- Visante

89 // Botulinum toxin PA – Are you exempt?

02-07-2023

The new year brings a new focus on resolutions including prior authorization processes. In July 2020, Medicare implemented a prior authorization process for select services including botulinum toxin. It’s time...

88 // Designer HCPCS Codes are in the Mainstream Spotlight

01-17-2023

The Pharmacy Revenue Cycle is starting out with a new fashion design for 2023 as there are 36 new brand-specific HCPCS codes. CMS has been reviewing its approach for assigning...

87 // Hospital Outpatient Prospective Payment System (OPPS) Final Rule- CY2023

12-22-2022

The Centers for Medicare & Medicaid Services (CMS) provided the OPPS Final Rule for CY2023 in the Federal Register on November 23, 2022. Provisions in this rule will be effective... for dates of service on or after January 1, 2023. Significant changes for drug reimbursement and coding occur in three areas: 340B-acquired drugs, non-opioid pain management reimbursement in Ambulatory Surgery Centers (ASC) and Hospital Outpatient Departments (HOPD), and new requirements for reporting waste in HOPD. 340B-acquired Drugs In light of the Supreme Court decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), CMS is applying the default rate, generally average sales price (ASP) plus 6 percent, to 340B acquired drugs and biologicals and removing the increase to the conversion factor that was made in CY 2018 to implement the 340B policy in a budget neutral manner. These changes are reflected in posted ASP Pricing Files and Addendum B reimbursement rates. Non-opioid pain management CMS will provide separate payment for five drugs in the ASC setting (but not in the HOPD setting) as non-opioid pain management drugs that function as supplies (Exparel, Omidria, Dextenza, Xaracoll, and Posimir). Note that Zynrelef received pass-through payment status on April 1, 2022 and is therefore eligible for separate payment in both the ASC and HOPD setting in CY2023. Drug Waste Reporting in Hospital Outpatient Departments New reporting requirements for drugs where there is no discarded waste were detailed in the CY2023 Physician Fee Schedule Rule and summarized in a recent Visante newsletter and podcast The following links and notes provide additional information on changes in drug reimbursement in HOPD for CY2023: Pass-through expirations CY 2022– 32 drugs will have pass-through payment end on December 31, 2022. Table 57 (page 198 pdf) Pass-through Drugs and biologicals that will receive one to four quarters of separate payment in CY 2023- 43 drugs will receive separate payment in one or more quarters in CY2023. Table 58 (pg 202 pdf) Pass-through Drugs and biologicals with pass-through payment status to expire after CY2023 (with pass-through payment end dates)- 49 drugs will continue with pass-through status throughout CY2023. Table 59 (pg 208 pdf) Packaging Threshold– CMS raises the per-day cost packaging threshold for separate payments from $130 to $135. Biosimilars– Visante has provided a recent newsletter that details payment increases for biosimilars. Hope this summary is helpful in evaluating your reimbursement for the coming year! SHOUT-OUT All pharmacy revenue cycle teams should review the OPPS CY 2023 Rule Final Rule and ensure systems are updated by January 1, 2023.

86 // Drug Waste is Packed with a Punch and a Refund

12-08-2022

Dive into the CY23 CMS Physician Fee Schedule rule as it relates to the new requirements for discarded drugs or drug waste. A JW and JZ modifier are required for...

85 // Payment Increases for Biosimilars

11-15-2022

On April 16th, 2022, the Inflation Reduction Act of 2022 was signed into law. Section 11403 requires a temporary increase in add-on payment for qualifying biosimilars from 6% to 8%...

84 // Car T-cell Therapy: Coverage and Billing-Outpatient (Updated – October 1, 2022)

11-01-2022

Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to... treat their cancer. This newsletter details coverage and billing instructions when the products are used on an outpatient basis and have been updated to reflect HCPCS codes current as of October 1, 2022. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a list of approved cellular and gene therapies including six that are Car T-cell therapies: ABECMA (idecabtagene vicleucel) BREYANZI (lisocabtagene maraleucel) CARVYKTI (ciltacabtagene autoleucel) KYMRIAH (tisagenlecleucel) TECARTUS (brexucabtagene autoleucel) YESCARTA (axicabtagene ciloleucel) Coverage CMS finalized a National Coverage Determination (NCD 110.24) on Car T-cell therapies on 8/7/2019. The NCD detailed that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when: Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) Used for a medically accepted indication, i.e. for either an FDA-approved indication as detailed in the FDA-approved label for the product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia When the above requirements are not met, the CAR T-cell therapy is non-covered. In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in NCD 310.1. Billing and Reimbursement HCPCS/CPT codes Billing for CAR T-cell therapy on outpatients includes HCPCS codes for the therapies as well as the administration. All CAR T-cell products should be billed with revenue code 891. Kymriah (tisagenlecleucel) is reported with HCPCS code Q2042- Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Yescarta (axicabtagene ciloleucel) is reported with HCPCS code Q2041- Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion. Tecartus- (brexucabtagene autoleucel) is reported with HCPCS code Q2053- Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, includimg leukapheresis and dose preparation procedures, per therapeutic dose. Breyanzi- (lisocabtagene maraleucel) is reported with HCPCS code Q2054- Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Abecma (idecabtagene vicleucel) is reported with HCPCS code Q2055- Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Carvykti (ciltacabtagene autoleucel) received FDA approval on 2/28/2022, and CMS has assigned a new HCPCS code effective October 1, 2022: code Q2056- Ciltacabtagene autoleucel, up to 100 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. The administration of any CAR T-cell therapy should be reported with CPT code 0540T- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. This CPT code should be reported with revenue code 874 – Infusion of Modified Cells w/CPT 0540T. Some payers also require that the claim include a new value code 86 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim. CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples of these two options for CAR T-cell billing for outpatients are available at CMS Transmittal #10454– (November 13, 2020). Revenue Codes CMS has also provided instructions for specific revenue codes to report all services associated with CAR T-cell therapy for inpatients and outpatients. The following Revenue Codes are used: 0871 – Cell Collection w/Current Procedural Technology (CPT) code 0537T 0872 – Specialized Biologic Processing and Storage – Prior to Transport w/CPT 0538T 0873 – Storage and Processing after Receipt of Cells from Manufacturer w/CPT 0539T 0874 – Infusion of Modified Cells w/CPT 0540T 0891 – Special Processed Drugs – FDA Approved Cell Therapy w/HCPCS Q2041, Q2042, or C9399 SHOUT-OUTS! Pharmacy and Revenue Integrity should determine if CAR T-cell therapy will be provided and ensure that appropriate chargemaster entries for the products are established with product specific HCPCS codes and the unique revenue code, 891. Pharmacy, Managed Care and Revenue Integrity should determine if any payers require the invoice cost to be added to the claim with value code 86 and establish a process to ensure that the invoice cost is correctly added to the claim. Revenue Integrity and HIM Coders should receive instructions as to which products will be utilized and the medical record location where the administration will be recorded. Pharmacy should ensure that if the product is administered under a clinical trial, or received at no cost from the manufacturer, it is clearly indicated in the medical record to ensure proper billing and coding. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

83 // Vacating the 340B Payment Reduction Policy

10-19-2022

On September 28, 2022 the US District Court issued a ruling that states the Department of Health and Human Services (HHS) is required to vacate the prospective portion of the...

82 // FY23 New Technology Add-On Payment for Inpatient Reimbursement

10-04-2022

The FY2023 Inpatient Prospective Payment System (IPPS) Final Rule was published in the Federal Register and is effective October 1, 2022. NTAP is considered for new services or technologies when:...

81 // Back to Flu Season

09-20-2022

It’s that time of year again when school supplies are purchased and vaccines are updated. Influenza vaccines continue to challenge organizations to ensure each NDC, CVX code and HCPCS code are...

80 // Comment Letter on IPPS FY2023 Proposed Rule and NDC Reporting for NTAP Drugs

07-19-2022

Dear Readers: Below is the content from a letter we submitted to CMS regarding their proposal in the IPPS FY2023 Proposed Rule to discontinue ICD-10-PCS codes for identifying drugs eligible... for NTAP and switch to requiring NDC numbers be reported on inpatient. We’ve made an alternate suggestion after talking with many of you, and also offered some important steps that should be taken to ensure the integrity of the data if CMS proceeds with this proposal. Please send us your feedback. We’ll do another analysis when the Final Rule is issued in August, prior to its implementation date of October 1, 2022. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. ****************************************** June 15, 2022 Via Electronic Submission to: http://www.regulations.gov (CMS-1771-P) Chiquita Brooks-Lasure, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS–1771-P P.O. Box 8013 Baltimore, MD 21244–1850 Re: Comments on The Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2023 Rate published in the May 10, 2022 Federal Register (CMS-1771-P) Dear Administrator Brooks-Lasure: We are pharmacists and consultants to health systems and practitioners in the area of pharmacy revenue cycle and are commenting on the proposal to change the claim identifier for drugs qualifying for New Technology Add-on Payment (NTAP) from the current ICD-10-PCS Code to the National Drug Code (NDC) number. This is found in section II.F.8.”Proposed Use of National Drug Codes (NDCs) To Identify Cases Involving Use of Therapeutic Agents Approved for New Technology Add-On Payment”- Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Proposed Rules/ page 28353. Background: The National Drug Code (NDC) number is a 10-digit number coordinated by the FDA which is reported on health claims as an 11-digit number. In the hospital environment, the NDC is stored in the Pharmacy IT system and is used in the clinical care of the patient for drug interaction checking, diagnosis conflicts, as well as safety aspects such as matching patient and medication through barcode medication administration and accurate restocking of floor stock supplies. Drug profiles are created in the Pharmacy IT system that have NDC numbers that link to billing information such as a procedure code, revenue code and HCPCS code as the HCPCS code has been the standard for reporting drugs for payment under the OPPS system since 2000. We understand that the ICD-10-PCS coding system was not designed to provide detailed coding for each drug manufactured. With the increased speed of FDA approval and the escalating costs of drugs, it has become cumbersome to have ICD-10-PCS codes issued for each drug, even when limiting the codes to only those drugs eligible for NTAP payment. I. Concerns in considering this proposal: Multiple ways to report drugs for payment based upon patient status and code sets Hospitals are faced with increasingly complex requirements to report drugs to secure reimbursement with variations based upon code sets and patient status. For Inpatient claims we have two ways of reporting drugs for additional payment: Hemophilia products are reported with HCPCS codes + billed units per date of service (DOS) NTAP-eligible drugs reported with ICD-10-PCS codes with only a single code independent of number of doses or days administered For Outpatient claims we report all drugs similar to Hemophilia products on inpatient claims (i.e. HCPCS code + billed units per DOS) with two nuances: Most oral drugs are not assigned HCPCS codes as they are typically self-administered drugs and not covered under Part B HCPCS Code C9399 (Unclassified drug or biological) is used for new drugs and biologicals that are approved by the FDA on or after January 1, 2004 for which a specific HCPCS code has not been assigned but CMS requires that the drug name, dose, amount of waste and National Drug Code (NDC) number be manually added to the remarks section of the claim. Hospital Pharmacy and Billing IT systems will need remediation with complex maintenance in order to accurately bill drugs based upon the type of drug, whether it is eligible for NTAP payment and the status of the patient. Changes in patient status will require programming to recalculate posted charges. Many hospitals currently do not bill some NTAP-eligible drugs due to the cumbersome process and low anticipated reimbursement. This can lead to inadvertent billing errors or omissions when a business decision is made that the anticipated payment will be less than the cost to remediate IT systems and maintain these complex billing rules. Inaccurate data could lead to erroneous future rate-setting by CMS when data is missing from claims. No national rules or standards on how to correctly code drugs using NDC numbers on 837I claims or that NDC numbers will be accepted by all payers on inpatient claims The 5010 HIPAA transaction standards define the NDC units of measure (F2, UN, GM, ML, ME), but do not define how they are to be applied in the hospital setting. There is no nationally recognized public or third-party database that authoritatively provides these instructions. State Medicaid programs have provided directions since requiring NDC numbers on outpatient claims beginning in 2006, but one eHR vendor has advised clients to use the “UN” unit of measure with a “unit” of “1” for all entries rather than using the most common four units of measure as directed by State Medicaid programs. In addition, vendors and providers also differ in the reporting of the actual NDC administered to the patient (usually captured with Bar-code Medication Administration (BCMA), or an NDC number that is retrieved from a database and “represents” what is administered to the patient matching only the generic identification but not the specific NDC number. Without specific guidance, current NDC reporting is often inaccurate resulting in increasing claim rejections for an invalid NDC number. Currently, some payers are requiring NDC numbers on outpatient claims, but rejecting the line if not reported with a HCPCS code. It is anticipated that this situation may occur similarly on inpatient claims with commercial payers. Future concerns with potential changes in FDA assignment of NDC numbers The FDA held public hearings in 2018 to receive input as the current structure of 10-digit NDC codes will run out of codes within 10-15 years. Although a path forward has not yet been announced, it is conceivable that a longer NDC number (e.g. 16 digits) may be required as early as 2028 requiring clinical and billing systems to be updated in all hospitals as well as updated 5010 requirements for standardized billing. CMS, MACs, and all payer systems will also require remediation to accommodate these changes. A summary of the public hearings is here: https://www.fda.gov/drugs/news-events-human-drugs/public-hearing-future-format-national-drug-code https://www.wolterskluwer.com/en/expert-insights/are-you-prepared-for-a-major-industry-change-to-the-national-drug-code-ndc-number II. Recommendations for CMS for this section of the Proposed Rule: Consider that NTAP-eligible drugs be billed on inpatient claims with the same instructions as currently used to report hemophilia products, i.e. with HCPCS codes and billing units by DOS. Having one way to bill drugs on inpatient and outpatient claims will reduce IT programming expense and reduce errors with increased standardization. Request that the CMS HCPCS Working Group assign HCPCS codes to items eligible for NTAP payments, even if they normally would not be assigned a HCPCS code (such as drugs with inpatient-only status, or an oral drug which is not usually covered under Part B). As HCPCS codes are assigned quarterly, this would eliminate the need for special notification if new NDC numbers are marketed after the implementation of the NTAP status and before the next rule-making cycle. If CMS adopts the proposed change to use NDC numbers to identify NTAP-eligible drugs on inpatient claims, we recommend that CMS should: Work with NUBC to provide further clarification on how these 5010 standard units of measure and billing quantities should be calculated and reported prior to utilizing the NDC number to drive payment. In effect, the unit of measure and billing quantity required with 5010 standards will be meaningless on inpatient or outpatient claims. Work with NUBC to require all payers to accept NDC numbers on inpatient claims to avoid payer-specific instructions which require complex and expensive IT programming. Provide additional details in rule-making which clarify whether the NDC reported on the claim must be from the package administered to the patient or whether it can be retrieved from a database and be “representative” of the drug administered to the patient, but not necessarily the exact NDC administered to the patient. Provide additional details in rule-making if multi-day therapies with NTAP-eligible drugs must be combined into a single line and reported only once at the start of therapy, or whether the NDC number can be reported on each DOS with the appropriate NDC unit of measure and NDC billed units and CMS will provide software logic to recognize the NDC and provide appropriate payment even if the NDC number is reported on multiple dates of service. Provide a notification process when a new NDC is marketed after final rule-making for the NTAP-eligible drug. This may be a result of improved packaging or when additional vial sizes are marketed. We appreciate CMS’ proposal to provide a streamlined mechanism for reporting certain drugs on inpatient claims as an alternative to ICD-10-PCS codes and appreciate the opportunity to comment on this proposal. Regards, Maxie Friemel, Pharm.D., CRCR. Visante, Senior Director, Pharmacy Revenue Cycle Agatha Nolen, Ph.D., D.Ph., FASHP, CRCR Visante, Billing Consultant

79 // Car T-cell Therapy: Coverage and Billing-Outpatient (7/1/2022 Update)

06-30-2022

Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to... treat their cancer. This newsletter details coverage and billing instructions when the products are used on an outpatient basis and has been updated to reflect HCPCS codes current as of July 1, 2022. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a list of approved cellular and gene therapies including six that are Car T-cell therapies: ABECMA (idecabtagene vicleucel) BREYANZI (lisocabtagene maraleucel) CARVYKTI (ciltacabtagene autoleucel) KYMRIAH (tisagenlecleucel) TECARTUS (brexucabtagene autoleucel) YESCARTA (axicabtagene ciloleucel) Coverage CMS finalized a National Coverage Determination (NCD 110.24) on Car T-cell therapies on 8/7/2019. The NCD detailed that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when: Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) Used for a medically accepted indication, i.e. for either an FDA-approved indication as detailed in the FDA-approved label for the product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia When the above requirements are not met, the CAR T-cell therapy is non-covered. In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in NCD 310.1. Billing and Reimbursement HCPCS/CPT codes Billing for CAR T-cell therapy on outpatients includes HCPCS codes for the therapies as well as the administration. All CAR T-cell products should be billed with revenue code 891. Kymriah (tisagenlecleucel) is reported with HCPCS code Q2042- Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Yescarta (axicabtagene ciloleucel) is reported with HCPCS code Q2041- Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion. Tecartus- (brexucabtagene autoleucel) is reported with HCPCS code Q2053- Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, includimg leukapheresis and dose preparation procedures, per therapeutic dose. Breyanzi- (lisocabtagene maraleucel) is reported with HCPCS code Q2054- Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Abecma (idecabtagene vicleucel) is reported with HCPCS code Q2055- Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Carvykti (ciltacabtagene autoleucel) received FDA approval on 2/28/2022, and CMS has assigned a HCPCS code effective July 1, 2022: code C9098- Ciltacabtagene autoleucel, up to 100 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. The administration of any CAR T-cell therapy should be reported with CPT code 0540T- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. This CPT code should be reported with revenue code 874 – Infusion of Modified Cells w/CPT 0540T. Some payers also require that the claim include a new value code 86 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim. CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples on these two options for CAR T-cell billing for outpatients is available at CMS Transmittal #10454– (November 13, 2020). Revenue Codes CMS has also provided instructions for specific revenue codes to report all services associated with CAR T-cell therapy for inpatients and outpatients. The following Revenue Codes are used: 0871 – Cell Collection w/Current Procedural Technology (CPT) code 0537T 0872 – Specialized Biologic Processing and Storage – Prior to Transport w/CPT 0538T 0873 – Storage and Processing after Receipt of Cells from Manufacturer w/CPT 0539T 0874 – Infusion of Modified Cells w/CPT 0540T 0891 – Special Processed Drugs – FDA Approved Cell Therapy w/HCPCS Q2041, Q2042, or C9399 SHOUT-OUTS! Pharmacy and Revenue Integrity should determine if CAR T-cell therapy will be provided and ensure that appropriate chargemaster entries for the products are established with product specific HCPCS codes and the unique revenue code, 891. Pharmacy, Managed Care and Revenue Integrity should determine if any payers require the invoice cost to be added to claim with value code 86 and establish a process to ensure that the invoice cost is correctly added to the claim. Revenue Integrity and HIM Coders should receive instructions as to which products will be utilized and the medical record location where the administration will be recorded. Pharmacy should ensure that if the product is administered under a clinical trial, or received at no cost from the manufacturer, that it is clearly indicated in the medical record to ensure proper billing and coding.

78 // What’s New? Using HCPCS Code C9399 (7/1/2022 Update)

06-15-2022

What’s NEW? Using HCPCS Code C9399 (July 1, 2022 update) HCPCS code C9399-Unclassifed drugs or biologicals, can be used to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that... are approved by the FDA on or after January 1, 2004 when a product-specific HCPCS code has not yet been assigned when furnished in hospital outpatient departments. (Medicare Claims Processing Manual, pg 63). This C9399 tool includes the generic and brand names, approval dates, manufacturer, and a link to the prescribing information (PI). (<link to spreadsheet on Tools>) for injectable drugs that have been approved by the FDA but have not been assigned a HCPCS code by CMS. This list is updated each quarter to reflect newly released HCPCS codes. These “Not-otherwise-classified codes” (e.g. C9399) should only be used when a more specific HCPCS code has not been assigned. What do I need to know about billing with C9399? HCPCS code C9399 is billed with a quantity of “1” (one) on the claim which is essentially a placeholder and directs the payer to review additional information in the NOTES section of the 837I claim. For Medicare and some other payers, discarded waste from separately payable single-dose vials must be recorded in the patient’s medical record. When reporting C9399, a separate charge line on the claim with the JW modifier should NOT be reported. Instead the amount administered and amount wasted (if documented) is reported in the NOTES section of the claim. For Medicare outpatients, when reporting C9399, hospitals must also report the National Drug Code (NDC) and quantity administered (expressed in the NDC unit of measure) as well as the date the drug was furnished in the NOTES section. For Medicare outpatients, the MAC will manually calculate the payment for the drug or biological at 95 percent of the average wholesale price (AWP). The MAC will pay 80 percent of the calculated payment to the hospital and the beneficiary will be responsible for the 20 percent co-pay after the deductible is met. Drugs/biologicals manually priced at 95 percent of AWP are not eligible for outlier payment. Other payers may pay similarly to Medicare or have an established fee schedules for new drugs. Some payers may provide alternate billing instructions (e.g. J3490, J3590) and they should be followed when available. Please note that physician offices are not eligible to bill using HCPCS codes beginning with “C”, and must select a different unclassified code, e.g. “J” code. Why have some drugs been approved for years, and still don’t have a HCPCS code assigned? The HCPCS Workgroup assigns HCPCS code quarterly and holds an annual Public Meeting to gain feedback on their preliminary decisions. Typically a manufacturer or insurer submits an on-line application requesting a HCPCS code assignment. Approved codes are posted on the CMS HCPCS Quarterly update page. What else should I know about these drugs that don’t have an assigned HCPCS code? Medicare may consider some of these drugs that are administered subcutaneously as “self-administered” and therefore not covered in a hospital outpatient department. For other payers, the drugs may be covered in a hospital outpatient department, or covered as a pharmacy benefit rather than the medical benefit. Medicare has also provided different instructions for billing diagnostic radiopharmaceuticals and contrast agents when a specific code has not been assigned. These instructions are available in the January 2017 OPPS update. Shout-outs! Pharmacy should review these 50+ C9399 drugs to determine if they are in use and if so, ensure that the HCPCS code C9399 is used for billing with revenue code 636. Finance should review payments for C9399 to determine if payers are reimbursing at 95% AWP (Medicare and payers like Medicare), or at a contracted fee schedule rate. Revenue Integrity should review any drugs in use to ensure they are not on the facility’s “Self-Administered Drug” listing from the MAC, and therefore not covered when furnished in a hospital outpatient department.

77 // Car T-cell Therapy-Billing and Coverage for Outpatients (Updated)

03-15-2022

Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to... treat their cancer. This newsletter details coverage and billing instructions when the products are used on an outpatient basis and has been updated to reflect HCPCS codes current as of April 1, 2022. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a list of approved cellular and gene therapies including six that are Car T-cell therapies: ABECMA (idecabtagene vicleucel) BREYANZI (lisocabtagene maraleucel) CARVYKTI (ciltacabtagene autoleucel) KYMRIAH (tisagenlecleucel) TECARTUS (brexucabtagene autoleucel) YESCARTA (axicabtagene ciloleucel) Coverage CMS finalized a National Coverage Determination (NCD 110.24) on Car T-cell therapies on 8/7/2019. The NCD detailed that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when: Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) Used for a medically accepted indication, i.e. for either an FDA-approved indication as detailed in the FDA-approved label for the product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia When the above requirements are not met, the CAR T-cell therapy is non-covered. In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in NCD 310.1. Billing and Reimbursement HCPCS/CPT codes Billing for CAR T-cell therapy on outpatients includes HCPCS codes for the therapies as well as the administration. All CAR T-cell products should be billed with revenue code 891. Kymriah (tisagenlecleucel) is reported with HCPCS code Q2042- Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Yescarta (axicabtagene ciloleucel) is reported with HCPCS code Q2041- Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion. Tecartus- (brexucabtagene autoleucel) is reported with HCPCS code Q2053- Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, includimg leukapheresis and dose preparation procedures, per therapeutic dose. Breyanzi- (lisocabtagene maraleucel) is reported with HCPCS code Q2054- Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Abecma (idecabtagene vicleucel) is reported with HCPCS code Q2055- Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Carvykti (ciltacabtagene autoleucel) (received FDA approval on 2/28/2022, but CMS has not yet assigned a HCPCS code and we recommend that this product be reported with C9399- Unclassified drugs or biologicals. This HCPCS code is used to report newly approved products prior to HCPCS specific code assignment. The administration of any CAR T-cell therapy should be reported with CPT code 0540T- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. This CPT code should be reported with revenue code 874 – Infusion of Modified Cells w/CPT 0540T. Some payers also require that the claim include a new value code 86

76 // If All Else Fails, Submit and Appeal

03-01-2022

It may seem like a scary or intimidating endeavor, but many pharmacy related denials can be overturned when following the appeal process. Medicare has five levels of appeals beginning with... a redetermination by the MAC to Judicial Review in the Federal District Court. Before beginning the appeals process, it is prudent to ensure that the claim was coded and billed accurately. Claims that have an error in billing may be corrected by re-submitting utilizing the corrected claim process. Additionally, it is important to understand the reason for the initial denial and ensure there is clinical justification or other supporting evidence for billing the denied service. Once your homework is complete and an appeal may be justified, follow the process outlined by the payer and work to overturn the denial. Each level of a Medicare appeal must be completed in writing and follow a specific set of instructions. This includes a specific form and each level outlines the number of days in which the appeal should be submitted from the time of the determination. Each appeal should clearly explain why the appellant disagrees with the decision made and provide any relevant documentation or other justification. First level of appeal is a redetermination by a Medicare Administrative Contractor (MAC), and must be submitted within 120 days from the date of the initial claim determination. Second level of appeal is a reconsideration by a Qualified Independent Contractor (QIC) in the event that any party is dissatisfied with the decision from the MAC. The appellant has 180 days from the receipt of the redetermination to file a reconsideration. Third level of appeal is to request a hearing before an Administrative Law Judge (ALJ). The hearing must be filed with the Office of Medicare Hearings and Appeals (OMHA) within 60 days of the reconsideration decision from the QIC. Fourth level of appeal is to request a review by the Medicare Appeals Council and must be filed within 60 days of the ALJ decision. Fifth level of appeal is to request a judicial review in Federal District Court within 60 days of the decision by the Council. Appealing a claim can be a lengthy process, but a worthy endeavor especially when high cost drug denials are on the line! Shout Outs! Revenue cycle teams should review denials to understand the root cause and submit a corrected claim (if applicable) prior to initiating an appeal. Pharmacy teams should be involved in the appeal process to assist with providing clinical justification for a denied drug. Revenue cycle teams should track each appeal to ensure reconsiderations are submitted in a timely fashion. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue. Reach out to Maxie! afriemel@visanteinc.com

75 // Convalescent Plasma: New HCPCS Code for Outpatients

02-15-2022

On December 28, 2021, the FDA revised the emergency use authorization (EUA) for COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies. It is now authorized in both the inpatient...

74 // Notice: Read All About an ABN

02-01-2022

Pharmacy teams are increasingly embedding themselves within revenue cycle teams and prior authorization processes within infusion and cancer centers as well as other outpatient departments. As this occurs the term... ABN may increasingly become an important factor that pharmacy teams otherwise would not originally have dealt with. Or, maybe you as a Medicare beneficiary have wondered what they are and their importance. Advance Beneficiary Notice of Noncoverage or ABN is a written notice given to Medicare fee-for-service or original Medicare beneficiaries to convey that the item or service may not be covered by Medicare Part B since they are medically unnecessary or custodial in nature. Examples of situations in which an ABN is required include: When a Medicare item or service isn’t reasonable and necessary When providing custodial care Experimental and investigational or considered research only Before providing preventative care that is usually covered but won’t be covered in specific situations in which it exceeds the frequency limits A more complete list may be found here ABNs are not required for items or services that are considered statutorily excluded by Medicare. They may be given on a voluntary basis or as a courtesy to the beneficiary notifying them of the potential financial liability. The primary example as it pertains to pharmacy is self-administered drugs that are statutorily excluded under payment from Medicare Part B. An ABN is prohibited when the service is denied due to a Medically Unlikely Edit or MUE or when Medicare covers the service under a bundled payment. Additionally, an ABN is not used for Medicare Part D. The ABN is a protective mechanism for both the Medicare beneficiary and provider related to financial liability. An ABN should be issued far enough in advance for the beneficiary to allow time for the patient to consider all available options. Ideally, an ABN is issued in person and explained in its entirety. The standard, approved form must be used and the patient must elect (option 1) to receive the treatment followed by a signature. When an ABN is issued appropriately to a beneficiary and the beneficiary agrees and signs, financial liability may shift from a provider to the beneficiary in the event of a Medicare denial. Shout Outs! Pharmacy and prior authorization teams should understand the ABN process upon evaluating National and Local Coverage Determinations (NCD and LCD) to understand when drugs may not be covered. Clinical teams should ensure documentation supports the medical necessity of the drug, and when a denial is received should determine if an appeal may be more appropriate based on clinical support prior to shifting liability to the patient. It is important to understand when it is required, voluntary and prohibited to issue an ABN to a Medicare beneficiary. Teams should evaluate that a signed form is on file prior to administering drugs that are considered not covered. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

73 // Aduhelm and Medicare Coverage

01-25-2022

On January 11, 2022, CMS released a proposed National Coverage Determination (NCD) decision memorandum which would cover monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage... with evidence development (CED). This means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in a qualifying clinical trial and it must be administered in a hospital outpatient setting. The proposed NCD is open to public comment and comments can be submitted until February 10, 2022 at the NCD database for CAG-00460N: https://www.cms.gov/medicare-coverage-database/view/nca.aspx?ncaid=305&bc=0. CMS anticipates a final decision by April 11, 2022. Currently Aduhelm is the only monoclonal antibody directed against amyloid beta approved by the FDA for the treatment of Alzheimer’s disease receiving approval on June 7, 2021. Initially the pharmaceutical company, Biogen, announced that the selling price would be $56,000 per patient per year. However, in December 2021, the company announced that it was cutting the price in half to $28,000 per patient per year. The cost and coverage has not been without controversy. As the target population is Medicare-age, CMS recalculated the premium costs for Part B coverage at the initial selling price, with Part B premiums increasing 14.5% in 2022 in part due to the uncertainty of the cost and coverage of Aduhelm. On January 10, 2022, Health and Human Services Secretary Xavier Becerra announced that he is instructing the Centers for Medicare & Medicaid Services to reassess this year’s standard premium in view of the proposed NCD and the manufacturer’s drop in price. To read the proposed National Coverage Determination decision memorandum, visit: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305 SHOUT-OUTS! 1. Pharmacy should be aware of developing CMS-criteria for monoclonal antibodies for the treatment of Alzheimer’s disease including the proposed requirement for the patient to be enrolled in a CMS-qualifying clinical trial with a final decision by April 11, 2022. 2. The monoclonal antibody must be administered in a hospital outpatient setting to be covered under the proposed NCD. 3. Facilities which anticipate providing monoclonal antibodies for Alzheimer’s patients should consider submitting comments to CMS by February 10, 2022 on the proposed NCD. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

72 // Covid Tidal Wave and Remdesivir Changes

01-18-2022

Many of you may be experiencing another tidal wave of surges with the Omicron Covid-19 variant. Though we have been fighting the pandemic for almost two years, each surge seems... to bring new battles. The NIH recently published new outpatient therapy guidelines to help combat the Omicron variant; as well as, we have received a few questions from our readers on how to handle the billing changes. Remdesivir is now among one of the treatment options for non-hospitalized patients when Omicron is the predominant circulating variant. CMS has designated HCPCS code J0248, injection remdesivir, 1 mg. The code is effective for dates of service beginning December 23, 2021 and may be used to rebill any previously administered outpatient remdesivir account. Remdesivir is FDA approved for hospitalized patients and utilizing remdesivir for outpatients is considered off-labeled. It is prudent to ensure patients meet the criteria outlined by the NIH to avoid any denials by the MACs. If denied for payment, following the appeal process to overturn any remdesiver when used according to recommendations. Note, Medicare beneficiaries will be responsible for the 20% deductible for the drug and administration of remdesivir. Currently, J0248 code for remdesivir has not been updated in the Outpatient Code Editor (OCE). Payers may not be able to process claims until this update has occurred. In which case, it may be advantageous to hold claims temporarily until the payers are ready to accept the newly created code. Other updates for Covid-19 Vaccine and Monoclonal Antibodies Effective January 1, 2022, Original Medicare (or Medicare Fee for Service) will no longer cover the vaccine or monoclonal antibodies on behalf of the Medicare Advantage (MA) plans. MA claims should have split any vaccine or covid related monoclonal antibodies to be billed to the Original Medicare plan. This claim split should be “undone” for any claims billed out after January 1, 2022. MA and Medicare plans will continue to cover the vaccine and monoclonal antibodies respectively once billed. Shout Outs! Pharmacy Revenue Cycle and Informatics Teams should update the CDM for remdesivir to reflect the new code J0248, injection 1 mg. Revenue Integrity teams should conduct an audit of any outpatient account who utilized remdesivir from dates of service December 23, 2021 to rebill accounts when used in accordance to the NIH guidelines. Revenue Integrity and Billing teams should monitor claims to ensure claim processing software at the MAC is accepting the new remdesivir code and may consider holding claims until they process cleanly. Billing teams should ensure that for dates of service Covid-19 vaccines and monoclonal antibody infusions prior to 2022 were billed to the Original Medicare for payment. Claims logic should be undone to allow for the traditional billing to both MA and Original Medicare. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

71 // Pegfilgrastim: Dose Change with New HCPCS Code

01-11-2022

January is always the biggest quarterly update for HCPCS codes and 2022 is no exception. Some changes are routine with new codes replacing temporary codes and new codes for newly...

70 // Sequestration Suspension Extended: Impact on Drug Reimbursement

01-04-2022

Pharmacy departments may periodically be asked to compare drug payment with cost, particularly when expensive drugs are utilized on outpatients. It is also important to calculate anticipated revenue when preparing... annual budgets. The ASP (Average Sales Price) file is published by CMS each quarter and can be used to verify payment for Medicare outpatients or commercial contracts which pay based upon Medicare payment. It sounds straightforward, but there is a catch: “sequestration”. Sequestration is the automatic reduction of federal spending originally established by Congress in the Balanced Budget and Emergency Deficit Control Act of 1985 (BBEDCA, also known as the Gramm-Rudman-Hollings Act). This applies to most areas of the federal budget but was first “triggered” for Medicare in FY2013 resulting in a 2% reduction in Medicare payments to providers over stated payment rates. This 2% reduction has continued each fiscal year until the pandemic when the sequestration was “suspended” meaning there is no current payment reduction and provided receive the full payment. The Protecting Medicare and American Farmers from Sequester Cuts Act was signed into law on December 10, 2021 and extends the suspension through March 31, 2022. However, the sequestration will be gradually applied once the extension expires. From April 1, 2022 through June 30, 2022, the payment adjustment will be 1% and effective July 1, 2022, the payment adjustment shall return to the 2% for all Medicare Fee-for-service claims. Any changes to this reinstatement would require further Congressional action. Because Medicare beneficiary co-payments are not subject to the payment reduction, they continue to pay the same co-payment amounts regardless of sequestration. Here’s a formula to use when the “sequestration” suspension begins to expire on April 1, 2022: ((Payment rate-copayment)*0.99)+ copayment Let’s take a drug example from January 2022. Using Addendum B, we see the following: Since Addendum B doesn’t have the dose description for this HCPCS code, we can find that information on the ASP file for the quarter: Denosumab, J0897 has a payment limit of $21.205 per 1 mg effective January 1, 2022 from the ASP file. Calculating the new payment rate when subject to a 1% sequestration results in the following: (($21.205-$4.25)*0.99) + $4.25 = $21.035 For a 60 mg dose, the payment difference is $10.173 (($21.205-$21.035)*60)) Note: The rates reflected in Addendum B are “unadjusted copayments” and these co-pay amounts may be different for different providers based upon geographic adjustments. SHOUT- OUTS Pharmacy and Finance should take into consideration if there is a payment “sequestration” triggered when projecting budgets and business plans especially for expensive drugs used on outpatients. Pharmacy and Finance should be aware of congressional actions which may impact drug payments. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

69 // Connecting the Dots: Pharmacy Involvement in Revenue Cycle

12-28-2021

It may seem like unnecessary work to review the items on our Quarterly Checklist each quarter to identify changes and updates. Some tasks may be delegated to other groups such... as Chargemaster Managers or Billers, but for one task, pharmacy is the best department to “connect the dots”: Restated Payment Rates. Our “action to take” recommendation is: “Map restated payments to the effective quarter, determine impact, and rebill as necessary.” We believe that the pharmacy department is in the best position to take this action and in some cases, increase pharmacy revenue. Let’s walk through an example in more depth. As noted on our Quarterly Checklist, CMS posts “restated payment rates” each quarter. For January 2022, the file has this information: Here are the steps to process this file to determine impact: 1. Review Addendum B for the appropriate quarter to determine what the posted payment rate was. Since the “payment” column includes the “copay”, it is only necessary to add the payment column from the previous quarter. 2. Calculate the payment difference. 3. Add the “short descriptor” from Addendum B to determine the HCPCS code dose amount. 4. If the “short descriptor” from Addendum B does not include the HCPCS code dose amount, go to the Alpha-Numeric HCPCS File on the HCPCS Quarterly Update page to retrieve the “long description”. Use the HCPCYYYY_MMM_ANWEB_vN.xlsx file. 5. Add prescribing information and calculate the average adult dose using 100 kg or 3M2 for BSA. For every 3 week regimens use 5 potential doses; for every 4 week regimens use 4 potential doses (assumes patient received first dose on first day of quarter). 6. Calculate the average payment difference for one quarter for one patient to determine financial impact of restated rates. In consultation with the Finance Department, Pharmacies should establish policies as to which payment difference amounts are “significant” to determine rebill potential. (In our example for January 2022, some providers would consider the $1320.00 to be significant and review accounts with HCPCS code J9353) 7. When rebill thresholds are met, Pharmacy should estimate the total change in revenue based upon actual patient usage and review potential rebills for the quarter with Finance to obtain authorization for rebilling. (Timely filing for Medicare is one year from date of service but rebills should be generated as soon as authorized). 8. Managed Care Contracting group should be notified to determine if any managed care contract payments are based upon Medicare rates and if rebilling of any commercial/Medicare advantage accounts is warranted. 9. Your completed analysis for finance review will look like this: SHOUT-OUTS 1. The Department of Pharmacy is in the best position to evaluate restated payment rates for drugs each quarter and provide information to Finance for potential rebilling opportunities. 2. The Finance Department should determine in advance a “payment threshold difference” which is considered “significant” to warrant further investigation into rebilling opportunities. 3. The Managed Care Contracting group should be notified if any HCPCS codes are selected to be rebilled to determine if any Commercial/Medicare Advantage payments are similarly impacted and to determine if those accounts should similarly be rebilled. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

68 // End of Year Checklist for New Codes

12-21-2021

The end of year brings joy and happiness, but it can also be a very busy time for the revenue cycle and finance teams conducting year end closes. Our goal...

67 // Dietary Supplements: Billing Pitfalls to Avoid

12-06-2021

Hospital pharmacies often carry and dispense dietary supplements and herbal products in order to maintain a patient on their home regimens. Pharmacies may determine which dietary supplements and herbal... products they carry based upon patient needs and internal policies, but they can’t be billed as a drug. What does that mean? Just like medical devices, dietary supplements and herbal products may be supplied by the pharmacy, but it is important that they NOT be billed as a drug as only drugs and biologicals are billed with revenue codes 25x (250-259) and 63x (631-637). It is important that these products NOT be set up in chargemasters under a 259 or 637 revenue code as these revenue codes are reserved for “self-administered drugs”. Since dietary supplements are not drugs, they can’t be billed as a self-administered drug and billed to a Medicare outpatient. Typically, facilities choose one of two options for billing and coding of dietary supplements and herbal products: Consider them as “supplies” and bill them with revenue code 27x, or Consider them as “nutritional supplements” including the cost in other services such as room and board on inpatients or within procedure charges for outpatients. A separate charge is not generated for this option. As we mentioned in our previous newsletter on medical devices, revenue codes are established by the National Uniform Billing Committee (NUBC) and they provide instructions on how they are to be used. All providers must follow the applicable rules from NUBC in billing for healthcare services. How can I tell if a product is a dietary supplement? There isn’t a comprehensive database like there is with drugs and the FDA NDC Directory. The easiest way is to look at the package (or Google an image) as these products must be clearly labelled as “dietary supplements”. Dietary supplements are prohibited from having an NDC number, so any 10- or 11-digit number on the package is for tracking only, and is not an NDC number. SHOUT-OUTS! 1. Pharmacy and Chargemaster Managers should review chargemaster entries to ensure that dietary supplements and herbal products are not billed with “pharmacy” revenue codes (i.e. 259 or 637) 2. Pharmacy should confirm that the set-up process for a new product includes checking to see if the product is a prescription or O-T-C drug, a medical device, a dietary supplement, or an herbal product. Only drugs and biologicals can be billed with pharmacy revenue codes such as 25x and 63x. 3. Pharmacy and Finance should determine if the facility will bill separately for non-drug products under a supply revenue code, 27x, or if they will not be billed separately and the cost will be included in charges for room and board or other procedures. Dietary supplements and herbal products are not drugs, and therefore cannot be billed to the patient as a self-administered drug with revenue code 259 or 637. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

66 // Everything’s made up and the points don’t matter. The points are like setting hospital drug charges.

12-14-2021

Have you ever thought the pharmacy charge structure could have been an intro to the Drew Carey Whose Line Is It Anyway? Well, that may be what most people think,... but with the new price transparency regulations that are being pushed forward, understanding how the drug charges are set and optimizing the charge structure is more important now than ever. CMS cannot dictate how much a provider charges, which leaves little guidance for hospitals. This edition will walk through at high level some strategies to consider when establishing the pharmacy markup structures. First and foremost! Charge enough so that the payer negotiated rate covers your actual acquisition cost. This may be a no-brainer, but is a common pitfall. Payer negotiated contracts should be taken into consideration when evaluating if the charge will recoup the cost. Take a deeper look at this simple example: Payer negotiated rate: 20% of charge Drug Cost: $1,000 Drug Markup: 1.5 x cost Gross Charge: $1,500 Reimbursement: $300 This is also true when charged at a flat fee schedule rate to ensure the charge is greater than the fee schedule. If charge is submitted less then the fee schedule, likely you will receive the lesser of the charge or fee schedule rate. This would be dependent on contract language, but emphasizes the importance of understanding payer contracts when evaluating pharmacy charge structure. Second, keep your strategy simple and justifiable. Markup structures range in complexity from very simple flat markups on cost to multi-cost tiers based on selected drug categories or methods. There are typically some basic elements to most charge structures. If not a straight markup, generally there are some form of categories or methods that drive drugs to selected markup formulas. Then, a base cost is selected (e.g. actual cost, WAC, AWP) and applied markup +/- additional fee. The multiple NDC, prices and dosages can all impact the charge for a similar drug. Drug categories or methods should be defined in a manner that can be consistently applied by all pharmacists, technicians or analysts who may build and maintain pharmacy charge records. Utilize a cost basis that is easily updated and preferably can be an automated process. Various wholesalers and EHR define units of measures differently and can lead to an over or underinflated charge. For example, you may purchase a bottle of 100 tablets as 1 each and dispense each tablet. Ensure you validate the “each” price in the EHR calculates that correct charge based on what is dispensed. Third, implement a routine maintenance process to ensure base cost is current. Updates or changes to the pharmacy markup structure should be a coordinated effort with the entities chargemaster and finance team. Small changes in drug markups may have large impacts on the hospital’s overall gross charge increase. Shout Outs! Review and understand drug markup structure and processes to ensure it is contemporary and definsable. Keep methodology and markup formulas simple. Updating pharmacy markup structures is a large undertaking and should be coordinated with the entity’s entire chargemaster charge updates. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

65 // The Basics of Critical Access Hospitals (CAHs)

11-29-2021

A reader inquired about Critical Access Hospitals (CAH), so we have put together a few items that pertain to the intricacies of CAHs and how they differ from the Hospital... Outpatient/Inpatient Departments. CAH are located in rural areas of a State that has established a Medicare rural hospital flexibility program, or located in a Metropolitan Statistical Area (MSA) that is treated as being located in a rural area based on law or regulation of the State. It is required to be more than a 35-mile drive from any other hospital or “necessary provider”. If located in mountainous terrain or areas with only secondary roads, the CAH is only required to be 15 miles from another necessary provider. Additional eligibility criteria include: Must provide 24-hour emergency care No more than 25 beds for acute inpatient care or skilled nursing facility swing beds Maintain an annual average length of stay of no longer than 96 hours Must be certified by CMS and required to meet the conditions of participations for CAH The first call out pertaining to CAH, is they are not reimbursed utilizing the inpatient prospective payment system (IPPS) or the outpatient prospective payment system (OPPS). The following reimbursement rules do not apply: The lesser of cost or charges rule Ceilings on hospital operating costs The reasonable compensation equivalent limits for physician services to hospitals 1- and 3- day payment window provisions. In other words, outpatient services provided within the 1- and 3- day payment window will continue to be paid as an outpatient service rather than bundled on the inpatient claim. Inpatient payment is based upon 101% of reasonable cost or some MACs may pay on a per diem rate. Outpatient payment can be made using one of two methods. Method I (standard option) in which professional services are billed to Part B and reimbursement is 101% of reasonable cost less the deductible and coinsurance amounts. CAHs have the option to elect an alternative payment method or Method II (optional) when professional services are billed to Part A. Payment is the sum of the 101% of the reasonable cost of the facility services and 115% of the Medicare Physician Fee Schedule (MPFS) for professional services, less any deductible or coinsurance. Refer to the respective MAC regarding billing guidance. CAH, while generally 340B eligible, are not required to report the TB or JG modifiers as we have discussed in a previous newsletter. CAH are not subject to regulations of the HOPPS; thus, regardless of payment methods chosen, they are not subject to the ASP reduction. Shout Outs! Health systems big or small should understand the differences and regulations when billing CAH from other hospital or physician departments. Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

64 // Top 5 Newsletters and NEWS

11-22-2021

Pharmacy Revenue Cycle News has brought you 61 tips to increase your pharmacy revenue since it was launched in September 2020. Since then, we’ve had over 13,000 visits to our... website with 278 subscribers! Thank you to our loyal subscribers! Our website is also a repository for regulatory information including billing and compliance information for hospitals, ambulatory surgery centers and physician offices. You can search the entire website here: https://www.pharmacyrevenuecycle.com/search-and-index. We’ve learned that some newsletters are more widely read than others. Our Top 5 newsletters of all time are: Don’t Let Rabies Take a Bite Out of Your Revenue! (1,323 visits) CAR T-cell Therapy: Coverage and Billing for Outpatients (1,136 visits) New Technology Add-on Payments (NTAP) (953 visits) Billing for Pharmacists’ Services provided in a Hospital Outpatient Department (706 visits) What about M1145? Don’t miss out on drug revenue (618 visits) We also have news! We are pleased to announce that Pharmacy Revenue Cycle will be joining forces with Visante in the coming weeks! Visante is a multidisciplinary, clinician-composed consulting firm specializing in transforming healthcare through pharmacy. Visante’s goal is to diagnose and solve complex problems, and our website, Pharmacy Revenue Cycle was created to make complex billing and coding issues more simple: it’s a natural fit! We plan to transition our subscribers seamlessly over the next few weeks so you will continue to receive Pharmacy Revenue Cycle News on its regular publication schedule. As always, if you would like to stop receiving our Newsletter, send a quick note to agatha@pharmacyrevenuecycle.com or maxie.friemel@pharmacyrevenuecycle.com and we’ll remove you from future emails. Thank you to our loyal subscribers. We’ve had great feedback in our first year and we hope to bring you useful information on increasing your pharmacy revenue for years to come! Maxie & Agatha Our goal is simple; we’re taking complex information and making it practical. Until our next edition, this is Maxie Friemel and Agatha Nolen providing you with tips for increasing your Pharmacy Revenue.

63 // Medical Devices: Billing Pitfalls to Avoid

11-15-2021

Hospital pharmacies often carry and dispense medical devices in order to administer medications, or as part of a package for operating room cases. Pharmacies may determine which medical devices... they carry based upon patient needs, but they can’t be billed as a drug. What does that mean? The National Uniform Billing Committee (NUBC) was formed in 1975 to develop and maintain a single billing form and standard data set to be used nationwide by institutional, private and public providers and payers for handling health care claims. Therefore, the Committee is responsible for establishing revenue codes that are used on hospital claims. Drugs and biologicals are billed with revenue codes 25x (250-259) and 63x (631-637). Special revenue codes have been developed for diagnostic and therapeutic radiopharmaceuticals (343/344) and Car T-cell therapy/gene therapy (891/892). Products which are NOT approved under the FDA’s drug and biological pathways are typically billed as a supply with revenue code 27x. Drugs and Biologics The pharmacy revenue codes are used to bill for drugs and biologics and include both prescription drugs and O-T-C drugs that have approval from the FDA and are listed in the National Drug Code Directory (which is updated daily). They also can be distinguished as entries often include an NDA/ANDA/BLA tag which indicates under which drug or biological pathway the products were approved. Often package inserts are available on the DAILYMED website that contains the necessary information. Medical Devices Medical Devices may include drugs within the device, but if the primary action of the product is due to the device and not the drug, it is labelled as a device rather than a drug. One common example is pre-filled heparin flush syringes of 1ml, 2 ml and 5 ml which are labelled as devices. However, products from Fresenius Kabi, Hospira, Baxter, and B. Braun which contain 200 units of heparin per 100 ml are all labeled as drugs (and approved under NDA/ANDAs). Other medical devices that may be dispensed by the hospital pharmacy include viscoelastics (Viscoat OVD, DuoVisc, DisCoVisc and Healon), Gelfilm and Gelfoam, and Aerochamber Plus. Other items that are used in the OR may appear similar but are approved as drugs or biologicals: Sterile Talc, Vistaseal, and Tisseel. By now you are probably asking: “So, I can go to the FDA NDC Directory, or DAILYMED to verify a product was approved under an NDA/ANDA or BLA, but where is a comprehensive list of all products labelled as a “device”? Unfortunately, the answer is, “There isn’t a list.” Medical Devices have a limited approval pathway and range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems. The FDA maintains the Medical Device Product Classification database which lists over 6,000 types of medical devices regulated by FDA’s Center for Medical Devices and Radiological Health (CDRH) and the classification assigned to each type. You can search the FDA Releasable 510(k) Database, but it often doesn’t return information unless the exact product name is searched. One of the best sources of information is the product itself where the package or package insert will often identify that it is a “device”. Why is this important? A product that is not a drug or biological cannot have a National Drug Code (NDC) number assigned. Payers who require an NDC number will often examine claim lines in revenue code 250 or 636 and require an NDC number. If non-drugs are reported in these revenue codes, 11-digit numbers reported are flagged as “invalid” and the entire claim may be rejected. Conversely, products labeled as drugs or biological should be reported in revenue codes 25x or 63x as managed care contracts often contain language for additional reimbursement for products appropriately reported in revenue code 636. Reporting these drugs/biologicals in a

62 // OPPS Final Rule Summary CY2022

11-08-2021

The Centers for Medicare & Medicaid Services (CMS) provided the Final Rule for CY2022 for the OPPS on November 2, 2021 as a display copy. This document was published in the Federal... Register on 11/16/2021 and will be effective for dates of service on or after January 1, 2022. (Links below and page numbers have been updated to reflect the Federal Register version). The good news is there aren’t major changes for drug reimbursement. We’ve recapped the majority of the drug-related issues here. Claims Data- Typically claims data from 2020 would be analyzed for determining payment starting January 1, 2022. However, due to the pandemic, CMS is exercising its authority and will use data from 2019 claims similar to what was proposed in the Inpatient Prospective Payment Rule for FY2022. Pass-through expirations CY 2021- 25 drugs had/will have pass-through payment expire between March 31, 2021 and December 31, 2021. Table 37. (page 63622 FR, 165 pdf) Pass-through expirations CY 2022- 26 drugs will have pass-through payment expire during CY2022. Table 38 (page 63625 FR, 168 pdf) Pass-through Drugs, devices and biologicals that will receive one to four quarters of separate payment in CY 2022- 27 drugs will receive separate payment in one or more quarters in CY2022. Table 43 (page 63662 FR, 205 pdf) Pass-through expirations after CY 2022- Due to the pandemic, CMS is using its equitable adjustment authority to provide up to four quarters of separate payment for 65 drugs and biologicals whose pass-through payment status after CY 2022. These are listed in Table 39 (page 63628 FR, 171 pdf) Packaging Threshold- CMS continues the per-day cost packaging threshold for separate payment at $130. 340B- CMS will continue lower reimbursement for 340B-purchased, non pass-through-drugs. Instead of the ASP+6% reimbursement for separately payable drugs, CMS will continue to reimburse at ASP-22.5%. Modifiers “JG” and “TB” will still be required. CMS explicitly states that any changes to the current 340B payment policy would be adopted through public notice and comment rulemaking. Biosimilar- CMS will continue its current policy to make all biological products eligible for pass-through payment and not just the first biosimilar product for a reference product. CMS will also continue its payment policy of paying non-pass-through biosimilars acquired under 340B at the biosimilar’s ASP-22.5% of the biosimilar ASP (and not the reference product ASP). Non-opioids-CMS will provide separate payment for four drugs in the ASC setting (but not in the HOPD setting) as non-opioid pain management drugs that function as supplies (Exparel, Omidria, Zynrelef, and Xaracoll). CMS finalized a regulatory text change to require that these and any additional non-opioid drugs have FDA approval, be approved for pain management or analgesia and for the drugs to have a per-day cost in excess of the OPPS drug packaging threshold, which for CY 2022 at $130. Hope this summary is helpful in evaluating your reimbursement for the coming year! SHOUT-OUT! All pharmacy revenue cycle teams should review the OPPS CY 2022 Rule Final Rule and ensure systems are updated by January 1, 2022.

61 // What about C Codes?

11-01-2021

Drugs and biologicals are generally labeled with JXXXX series HCPCS, but there are a growing number of QXXXX, AXXXX, and now CXXXX. The C codes have generated some confusion and... are a pain point in maintaining the CDM. But what makes a C code different when it comes to the pharmacy revenue cycle? To start with a little history, C codes were created as a way to implement Section 201 of the Balanced Budget Refinement Act (BBRA) of 1999 or “pass through” payment. The C codes represented items that qualified for payment under the Outpatient Prospective Payment System (OPPS). Primarily, this was used exclusively for services that qualified for pass through payment. Drugs and biologicals, when qualified, are granted pass through status for 2 to 3 years before being assigned as non-pass through or packaged (see previous newsletter). CMS does not depend on the HCPCS assignment for a drug and biological for it to receive pass through status. Drugs may be assigned a C code, temporarily, until they are assigned a permanent HCPCS code. Prior to 2006, C codes were exclusively used by hospitals and were not payable by any other provider outside of the OPPS. As the C codes evolved, other providers requested the use of C codes. Effective October 1, 2006 following providers may elect to use a C code, but are not eligible to receive pass through payment: Critical Access Hospitals (CAH) Indian Health Service Hospitals (IHS) Hospitals located in American Samoa, Guam, Saipan or the Virgin Islands Maryland waiver hospitals The major call out in this list is missing professional or physician based offices. These locations are paid under the Medicare Physician Fee Schedule (MPFS) and are not considered an OPPS provider. Therefore, C codes are not eligible codes and an alternative non specified HCPCS may be required to bill as an alternative. Shout Outs! Pharmacy and Revenue Integrity – keep a close eye on any drugs assigned with a C code. These codes are temporary codes that may be replaced by permanent HCPCS codes. When they are updated, CDMs should be immediately updated or denials may be received. Pharmacy and Revenue Integrity teams with physician based offices – conduct a review of any C codes that potentially were billed in this setting as they may have ended in a denial or non-payment. Consider using an alternative J3590 or other non-specified code as an alternative.

60 // NDC Numbers: Medicaid Program Data

10-25-2021

CMS requires all State Medicaid Programs to require National Drug Code (NDC) numbers on “physician-administered” drugs which include those administered in hospital outpatient departments and physician offices. Since Medicaid programs... are jointly funded with CMS, this requirement applies to drugs which are covered under Medicare Part B. The program requires a drug manufacturer to enter into a national rebate agreements with the Secretary of the Department of Health and Human Services (HHS) in exchange for the State Medicaid program providing coverage for most of the manufacturer’s drugs. The manufacturer has to electronically submit product and pricing data to CMS when a new product is marketed. Manufacturers are required to report all covered outpatient drugs under their labeler code and may not be selective in reporting their NDC numbers. Manufacturers then pay a rebate to the State when payment is made under the state plan. CMS publishes a database of all NDC numbers reported to them as eligible for rebates. States cannot provide coverage for NDC numbers that are not included in the manufacturer’s agreement and many States use this database to evaluate claims submitted from hospital outpatient departments. If the NDC number is not listed in the database, an “invalid NDC” reason code may be sent back to the provider with a rejection for either the single line, or the entire claim. The database was last updated on August 30, 2021 and contains information pertaining to quarters from 2014 3QU through 2021 2QU. The 2021 2nd Quarter data contains 41,895 entries. The database can be filtered for any fields included in the database. The database contains prescription and OTC drugs with associated information such as the product name, unit type, units per package size, product name, FDA approval date and a clotting indicator, pediatric indicator, and innovator indicator. It is important to note that although some manufacturer catalogs assign an “NDC number” to other products such as medical devices and dietary supplements, these products are not registered with the FDA as drugs and therefore cannot have an NDC number assigned. These non-drug products should not be reported in a pharmacy revenue code (such as 25x or 63x), nor have an 11-digit number reported on the claim. Since they are not drugs and not included in the CMS Medicaid Rebate Program database, reporting these numbers for medical devices and dietary supplements will often cause claim rejections from State Medicaid Programs. Note that according to the Social Security Act, vaccines are not considered a covered outpatient drug under Part B. Although State Medicaid programs may provide coverage for vaccines, these NDC numbers are not reported to CMS for inclusion in the Medicaid rebate database. SHOUT OUTS! 1. Pharmacy and Pharmacy IT teams should ensure that only drugs (Prescription and OTC) are setup to report NDC number on outpatient claims. 2. Claims rejected with an “invalid NDC” reason code should be researched and rejected State Medicaid claims should be compared to the CMS Medicaid Rebate Program Data file to ensure the NDC administered to the patient is a “rebatable” drug and therefore a covered outpatient drug. 3. If a valid vaccine NDC number is rejected by a State Medicaid Program on a hospital outpatient claim, the State Medicaid program should be contacted to determine the reason for the rejection as a State Medicaid Program may require an NDC number for vaccines, but the NDC numbers are not reported to CMS for verification purposes.

59 // Preventative Vaccines

10-18-2021

Influenza, pneumococcal, and hepatitis B (intermediate or high risk, 50.4.4.2) may all be preventative vaccines, but the vaccine and its administration are covered 100% by Medicare Part B regardless of where...

58 // Cetuximab MUE increased to 150 units

10-11-2021

In our July 12, 2021 Newsletter, we reported that a new regimen was approved by the FDA for Cetuximab that exceeded the current Medically Unlikely Edits. We wrote a letter...

57 // Quarterly Update Checklist Tool

10-04-2021

“Teach a man to fish, and you’ve fed him for a lifetime” is a popular quote. Pharmacy Revenue Cycle News reviewed the July 1, 2021 updates for you, and now has...

56 // NTAP FY2022

09-27-2021

The FY2022 Inpatient Prospective Payment System (IPPS) Final Rule was published in the Federal Register and is effective October 1, 2021. Of which, the New Technology Add-on Payments (NTAP) are a... big aspect and impact the Pharmacy Revenue Cycle. NTAP is considered for new services or technologies when: 1) they are new and not substantially similar to other existing services or technology; 2) the services or technology is more costly or the MS-DRG payment is inadequate for coverage of the new technology; 3) and the service or technology demonstrates substantial clinical improvements over existing services or technology with the exception of certain antimicrobials. Antimicrobials approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) and are authorized by the FDA as a Qualified Infectious Disease Product (QIDP) are not required to meet the requirement that it represents an advance that substantially improves. The maximum add-on payment for the technology or service is equal to the lesser of 65% of the cost of the new technology or 65% of the amount by which the cost exceeds the standard DRG payment. For technology approved through the LPAD, the payment threshold is 75%. The NTAP tool provided by Pharmacy Revenue Cycle has been updated to reflect the FY22 changes that impact the drugs and biologicals. The crosswalk contains the newness start date, NTAP status, maximum NTAP payment and the associated ICD-10-PCS codes. It is noted that 2019 claims data was utilized over the 2020 for the purposes of restating payments thresholds. In summary: 9 drugs were granted an additional year of NTAP that would have otherwise been discontinued for FY22 based on the newness criterion 8 drugs continue NTAP eligibility 7 drugs became eligible 3 applications were denied NTAP eligible Fetroja and Recarbrio both submitted new applications based on the FDA approval of the indication hospital acquired bacterial pneumonia and ventilator-associated bacterial pneumonia despite having a baseline continued NTAP status. The max payment rates were adjusted to reflect updated data based on the new indication. Remdesivir (Veklury) was approved for NTAP with the newness date starting with the time it was authorized by the FDA for the Emergency Use Authorization (EUA). Remdesivir is the only drug that is approved for both NTAP and NCTAP (New Covid-19 Treatment Add0on Payment), but will continue to receive payment equal to that as if only it was eligible for NCTAP. Shout Outs! Pharmacy team and HIM/Coding teams should collaborate to ensure that the system is updated for proper capture and application of the ICD-10-PCS codes to the claim. Without the ICD-10-PCS code, the claim will not process the NTAP payment. Pharmacy teams should take into consideration NTAP payment in formulary decision making, but note these payments only last for 2 to 3 years.

55 // Happy Birthday Pharmacy Revenue Cycle News

09-21-2021

We started Pharmacy Revenue Cycle News in September 2020 to take complex billing and coding information for drugs and make it more simple. We’ve provided a weekly newsletter and podcast...

53 // Tocilizumab for Inpatient Covid-19 inpatients

09-07-2021

How do you bill an outpatient monoclonal antibody used in a hospitalized Covid-19 patient in which the facility incurs a cost? This seems to be one of many riddles to... solve as we continue to fight the Covid-19 pandemic. Tocilizumab under the EUA is approved for hospitalized patients > 2 years of age receiving corticosteroids and requiring supplemental oxygen. CMS issued its separate HCPCS, Q0249, from that of the original HCPCS, J3262 used when given for FDA approved indications. Similar to the vaccines, there are two separate HCPCS codes for the 1st administration (M0249) and 2nd administration (M0250). However, unlike the other monoclonal antibodies used for treatment of Covid-19, tocilizumab is provided in an inpatient setting. The tocilizumab should be billed on a 12X type of bill (inpatient Part B hospital claim) which must be separated from the type of bill 11x inpatient claim. Each MAC may have its own variation of how claims should be billed. Novitas outlines using 1 mg per billed unit (i.e. 200 units per dose) and billing only one line of Q0249 per day. Administration charges should be billed under a revenue code 771 with the condition code 91. Unlike remdesivir, they are not eligible for the New Covid-19 Technology Add on Payment (NCTAP). Q0249 should be paid at reasonable cost similar to billing influenza vaccine in the hospital setting. You may encounter additional scenarios where inpatients receive tocilizumab, but not for CVOD-19. Two examples would be for an inpatient who receives tocilizumab for rheumatoid arthritis and is due for another dose, or a CAR T-cell therapy patient who develops cytokine release syndrome. These scenarios are billed differently, with different anticipated reimbursements. A summary table for billing of tocilizumab in a hospital setting: Shout Outs! Pharmacy and Coding/HIM teams should collaborate on an appropriate workflow to ensure that the administration codes for tocilizumab are billed on the inpatient treated for Covid-19. Billing and Informatic teams should validate inpatient hospital claims and display the HCPCS codes Q0249, M0249, and M0250 on the claim and are not rolled into a single line under the respective revenue codes. Billing team should set up a process similar to the influenza vaccines that separates the tocilizumab onto a type of bill 12x inpatient Part B claim versus billing out on the type of bill 11x inpatient claim. Pharmacy or Revenue Integrity teams should conduct an audit to validate the coding, revenue codes and claims were billed correctly. CMS website with instructions on monoclonal antibody infusions is here.

53 // CAR T-cell Therapy: Coverage and Billing for Outpatients

09-13-2021

Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to... treat their cancer. Accurate billing for these products and the associated services is extremely important due to the cost and clinical resource intensity of administering the products. We previously provided instructions for the billing of CAR T-cell therapies when provided to an outpatient. This newsletter provides billing and reimbursement information when these products are administered to hospital inpatients. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a list of approved cellular and gene therapies including five that are Car T-cell therapies (current as of 09/09/2021): KYMRIAH (tisagenlecleucel) YESCARTA (axicabtagene ciloleucel) BREYANZI (lisocabtagene maraleucel) ABECMA (idecabtagene vicleucel) TECARTUS (brexucabtagene autoleucel) Coverage CMS finalized a National Coverage Determination (NCD 110.24) on CAR T-cell therapies on 8/7/2019 and has published a revision scheduled to be implemented on 09/20/2021. The revisions include additional general information about the use of CAR T-cell therapies in cancer, and to add HCPCS code C9076 for Breyanzi to the list of covered products. This information is in CMS Transmittal 10891 issued on July 20, 2021. The NCD details that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when: Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS), and, Used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) – i.e. is used for either an FDA-approved indication (according to the FDA-approved label for the product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia The use of non-FDA-approved autologous T-cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the requirements noted above are not met. In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in NCD 310.1. NOTE: The use of allogenic T-cells from healthy donors are not autologous CAR T treatments and should not be billed as autologous CAR-T treatments. NOTE: As specific codes are created for current and future FDA-approved CAR T-cell therapies, the MACs will update their local systems and websites accordingly. Billing and Reimbursement General Billing All CAR T-cell products should be billed using revenue code 891- – Special Processed Drugs – FDA (U.S. Food and Drug Administration) Approved Cell Therapy – Charges for Modified cell therapy. CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples on these two options for CAR T-cell billing for outpatients is available at CMS Transmittal #10454- (November 13, 2020) and MLN Matters Article SE19009 (May 28, 2019). Some payers also require that the claim include a new value code 86 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim. Product Reimbursement Kymriah and Yescarta From October 1, 2018 until September 30, 2020, Kymriah and Yescarta received New Technology Add

52 // Billing Tocilizumab and Alternatives

09-03-2021

Delta variant is creating some commotion to say the least. Tocilizumab (Actemra) used to treat rheumatoid arthritis among other things is now being used to treat hospitalized patients with Covid-19... under an EUA. The storm has created a world wide shortage leaving organizations up to their own devices to battle hospitalized Covid-19 patients and patients who were actively being treated with tocilizumab for other indications. While you focus on treating patients, we are here to help iron out the billing implications whichever method you choose. While we do not provide recommendations for clinical alternatives, here are some things to consider when transitioning patients to a new therapy in outpatient departments (hospital or physician office). Do you have an updated prior authorization in place for the alternative? Commercial payers may require a new prior authorization to be obtained when transitioning therapy to an alternative. Does the alternative meet medical necessity? CMS does not have prior authorization requirements for these agents, but should search for any LCD/NCD to ensure medical necessity is covered. Commercial payers may have additional requirements or policies for individual drugs that must be met to meet medical necessity. If the alternative is a subcutaneous formulation, is the medication considered a self-administered drug? Subcutaneous alternatives to tocilizumab may have a high propensity to be listed on the self-administered exclusion lists outlined by individual MACs. Neither the drug nor the administration of the drug may be billed to a Medicare beneficiary when listed as a self-administered drug. Denials for SAD may not be appealed since they are considered statutorily excluded from Medicare Part B payment. Reference our previous newsletter regarding billing for SADs. The alternative chosen did NOT have an FDA labeled indication for my patient and did not meet the medical necessity requirements in the policies. What should I do? Despite best efforts, there may be alternatives that are chosen that do not have an FDA approved indication for the respective patient diagnosis or the alternative did not meet all the requirements in the medical necessity policies. Ensure there is appropriate documentation in the chart that justifies why the alternative was chosen and document that the preferred agent, tocilizumab, is on a national shortage. Follow the claim and monitor for a potential denial. Upon receiving a denial, submit an appeal and provide the clinical justification for the alternative selected during a shortage. Reference our previous newsletter regarding billing when FDA off-labeled. Shout Outs! Pre-access, pharmacy, revenue integrity and appeals teams – coordinated efforts among the entire pharmacy revenue cycle process should be involved depending on the alternative therapy selected for tocilizumab during the shortage. Reference back to our previous newsletters regarding SAD and FDA off-label indications for more details on billing in these situations.

51 // Why Should I Report Every Drug Separately? Extra Money?

08-30-2021

We often hear, “We don’t bill the contrast material separately. We know it’s a drug, but we include the cost in the charge for the procedure so we don’t have... to keep updating the drug files” or “We only report HCPCS-coded drugs separately since we don’t get paid for the rest.” There are good reasons to report ALL Drugs, biologicals and radiopharmaceuticals separately on claims: CMS requires all separately payable drugs to be reported separately CMS requests all drugs be reported separately so that they can properly allocate packaged costs when setting payment rates in the OPPS rule each year Managed care payers often have “carve-out” payments for drugs reported in revenue code 636 (Drugs requiring detailed coding) when reported on both inpatient and outpatient claims Outlier payments are calculated on all charges reported for inpatients and outpatients. Since our focus is on revenue generation, let’s discuss more details for reasons #4 and #5. 1. Managed Care payers often have “carve-out” payments in revenue code 636 Commercial payers negotiate contracts that often contain “carve-out” payments for drugs that are reported in revenue code 636. These drugs must have a HCPCS code reported and the negotiated payment rate is based upon the charges aggregated in revenue code 636. This can apply to both outpatients (where HCPCS and revenue codes are reported), or inpatients (where the charges are aggregated into a single charge line for revenue code 636). So in the scenario where contrast media is not reported separately, the commercial payer cannot recognize that contrast was administered, and therefore will not make the additional payment as specified in the contract. We’ve seen contracts that pay 50-100% of charges, so this can add up quickly! And don’t forget that many “new” drugs should be billed with C9399 with revenue code 636 until they are assigned a permanent HCPCS code! Check out our quarterly C9399 tool here. 2. Outlier payments on inpatients and outpatients Outlier payments are calculated by CMS on both inpatient and outpatient claims and may be negotiated on commercial payer contracts. For CMS, “outlier payments” are calculated when the total charges on a claim exceed a standard threshold. For inpatient claims, Hospital-specific cost-to-charge ratios are applied to the covered charges for a case to determine whether the costs of the case exceed the fixed-loss outlier threshold. Payments for eligible cases are then made based on a marginal cost factor, which is a percentage of the costs above the threshold. The Proposed FY2022 IPPS Rule has proposed an outlier fixed-loss amount of $30,967. Outlier payments for any year are projected to be not less than 5 percent nor more than 6 percent of total operating payments plus outlier payments. For FY2022, the proposed target is 5.1 percent. By reporting all charges separately, it is more likely that all costs and charges are captured which can result in outlier payments. For outpatient claims, the projected target for aggregate outlier payments is 1.0 percent of the aggregate total payment under the OPPS. For CY2022, the proposed hospital outlier threshold would be set to trigger outlier payments when a hospital’s cost exceeds 1.75 times the APC payment and exceeds the APC Payment amount plus $6100. In addition, CMS recalculates outpatient payment rates for drugs every quarter and some drugs switch from being included as a “packaged payment” to being separately reimbursed. If you decide to only report drugs with separate payment, you have to keep up with payment changes every quarter. Isn’t it better to plan to report all drugs, biologicals and radiopharmaceuticals so that costs can appropriately be allocated and payments can be verified? SHOUT-OUTS Pharmacy IT teams should plan to create billing profiles for all drugs in use in a facility regardless of reimbursement status. I

50 // Why Should I Report Every Drug Separately? Extra Money?

08-23-2021

We often hear, “We don’t bill the contrast material separately. We know it’s a drug, but we include the cost in the charge for the procedure so we don’t have... to keep updating the drug files” or “We only report HCPCS-coded drugs separately since we don’t get paid for the rest.” There are good reasons to report ALL Drugs, biologicals and radiopharmaceuticals separately on claims: CMS requires all separately payable drugs to be reported separately CMS requests all drugs be reported separately so that they can properly allocate packaged costs when setting payment rates in the OPPS rule each year Managed care payers often have “carve-out” payments for drugs reported in revenue code 636 (Drugs requiring detailed coding) when reported on both inpatient and outpatient claims Outlier payments are calculated on all charges reported for inpatients and outpatients. Since our focus is on revenue generation, let’s discuss more details for reasons #4 and #5. 1. Managed Care payers often have “carve-out” payments in revenue code 636 Commercial payers negotiate contracts that often contain “carve-out” payments for drugs that are reported in revenue code 636. These drugs must have a HCPCS code reported and the negotiated payment rate is based upon the charges aggregated in revenue code 636. This can apply to both outpatients (where HCPCS and revenue codes are reported), or inpatients (where the charges are aggregated into a single charge line for revenue code 636). So in the scenario where contrast media is not reported separately, the commercial payer cannot recognize that contrast was administered, and therefore will not make the additional payment as specified in the contract. We’ve seen contracts that pay 50-100% of charges, so this can add up quickly! And don’t forget that many “new” drugs should be billed with C9399 with revenue code 636 until they are assigned a permanent HCPCS code! Check out our quarterly C9399 tool here. 2. Outlier payments on inpatients and outpatients Outlier payments are calculated by CMS on both inpatient and outpatient claims and may be negotiated on commercial payer contracts. For CMS, “outlier payments” are calculated when the total charges on a claim exceed a standard threshold. For inpatient claims, Hospital-specific cost-to-charge ratios are applied to the covered charges for a case to determine whether the costs of the case exceed the fixed-loss outlier threshold. Payments for eligible cases are then made based on a marginal cost factor, which is a percentage of the costs above the threshold. The Proposed FY2022 IPPS Rule has proposed an outlier fixed-loss amount of $30,967. Outlier payments for any year are projected to be not less than 5 percent nor more than 6 percent of total operating payments plus outlier payments. For FY2022, the proposed target is 5.1 percent. By reporting all charges separately, it is more likely that all costs and charges are captured which can result in outlier payments. For outpatient claims, the projected target for aggregate outlier payments is 1.0 percent of the aggregate total payment under the OPPS. For CY2022, the proposed hospital outlier threshold would be set to trigger outlier payments when a hospital’s cost exceeds 1.75 times the APC payment and exceeds the APC Payment amount plus $6100. In addition, CMS recalculates outpatient payment rates for drugs every quarter and some drugs switch from being included as a “packaged payment” to being separately reimbursed. If you decide to only report drugs with separate payment, you have to keep up with payment changes every quarter. Isn’t it better to plan to report all drugs, biologicals and radiopharmaceuticals so that costs can appropriately be allocated and payments can be verified? SHOUT-OUTS Pharmacy IT teams should plan to create billing profiles for all drugs in use in a facility regardless of reimbursement status. I

49 // MFN Model Rule-Proposal to Rescind

08-17-2021

CMS has issued a proposed rule to rescind the Most Favored Nation (MFN) interim final rule that appeared in the Federal Register on November 27, 2020. There will be a...

48 // CMS issues billing codes for 3rd dose of Pfizer and Moderna COVID-19 vaccine

08-09-2021

On August 16, 2021, CMS issued a special bulletin: Effective August 12, 2021, CMS will pay to administer additional doses of COVID-19 vaccines consistent with the FDA EUAs, using... CPT code 0003A for the Pfizer vaccine and CPT code 0013A for the Moderna vaccine. A table of all current COVID-19 vaccines and monoclonal antibody codes is available at this link. CMS will pay the same amount to administer this additional dose as they did for other doses of the COVID-19 vaccine (approximately $40 each (subject to site of care and geographic adjustments)). CMS continues to make it clear to private insurers and Medicaid programs that they are responsible to cover these products and administration services at no charge to beneficiaries. Please note: CMS will need to complete claims system updates in order to process and pay these new codes appropriately which they anticipate will be no later than August 27. CMS will hold, and then process all claims with these codes after they complete claims system updates. There are no changes in the CPT codes to report the vaccine products; these new codes are for the administration of the vaccine. The Centers for Disease Control and Prevention updated their website on August 16, 2021 to provide guidance on COVID-19 Vaccines for Moderately to Severely Immunocompromised People. Currently CDC is recommending that the following populations receive an additional dose: Been receiving active cancer treatment for tumors or cancers of the blood Received an organ transplant and are taking medicine to suppress the immune system Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome) Advanced or untreated HIV infection Active treatment with high-dose corticosteroids or other drugs that may suppress the immune response Although a physician’s order is not required to obtain the 3rd dose of the COVID-19 vaccine, the CDC recommends that individuals should talk with their healthcare provider about their medical condition, and whether getting an additional dose is appropriate for them. SHOUT-OUTS Pharmacy and Billing IT Systems should be updated with the appropriate HCPCS codes to bill for the administration of the 3rd dose of COVID-19 vaccines as specified in the newly revised Emergency Use Authorizations (EUA) for the Pfizer and Moderna vaccines. Prescribers ordering COVID-19 vaccines should indicate if the dose is a 3rd dose of Pfizer or Moderna vaccine to ensure that the correct billing code is reported on the claim. CDC is sponsoring an informational webinar on August 17 at 2PM ET. Registration is at this link. Providers should know the distinction between an “additional dose” and a “booster dose”. Additional dose vs booster dose definition: Additional dose: administration of an additional vaccine dose when the initial immune response following a primary vaccine series is likely to be insufficient. Booster dose: a dose of vaccine when the initial sufficient immune response to a primary vaccine series is likely to have waned over time. The need for and timing of a COVID-19 booster dose has not been established.

47 // Chemotherapy Administration Codes-Change in Billing Instructions

08-03-2021

The American Medical Association (AMA) is responsible for the maintenance of the Current Procedural Terminology (CPT) codes. Drug administration services are reported with CPT codes in the range 96360-96379 for... Hydration, Therapeutic, Prophylactic, and Diagnostic Injections and Infusions, and range 96401-96549 for Chemotherapy and Other Highly Complex Drug or Highly Complex Biologic Agent Administration. Drug Administration services codes are typically billed on outpatient claims. The CPT manual provides guidance on when the higher-reimbursed “Chemotherapy/Highly Complex” codes can be used which includes non-radionuclide anti-neoplastic agents, anti-neoplastic agents provided for noncancer diagnoses or substances such as certain monoclonal antibody agents (“MABs”) and other biologic response modifiers. Drugs which are included as billed with “Chemotherapy/Highly Complex” codes meet detailed criteria including requiring advanced training and competency for administration, have special considerations for preparation, dosage, or disposal and present significant patient risk and frequent monitoring. Additional criteria and examples are included in the CPT 2021 Professional Edition. In the Medicare Claims Processing Manual (100-04), Chapter 12, Section 30.5, (pg. 28 pdf), CMS provides guidance that typically, infliximab, rituximab, alemtuzumab, gemtuzumab and trastuzumab are considered to fall under the category of monoclonal antibodies and that leuprolide and goserelin acetate fall under the category of hormonal antineoplastics. CMS notes that this is not intended to be a complete list and that the MACs may provide additional guidance as to which drugs may be considered to be chemotherapy under Medicare. Previously, MACs would provide guidance in Local Coverage Articles (LCAs) both for drugs which should not be billed with chemotherapy administration codes and those which could. One example is a “retired” LCA from Noridian. This LCA stated that drugs in the J9000-J9999 range could be billed with chemo administration codes as well as drugs listed as Group 3 or Group 4 codes. However, it looks like there has been a procedural change. We’ve reviewed LCAs from all MACs and find the MACs are no longer listing drugs that can be billed with chemotherapy codes just based upon the drugs but instead are only listing those drugs that can’t be billed with chemotherapy codes. In fact, the current LCA (effective 07/23/2021) contains the following language: “The Medicare Administrative Contractor has determined in review of submitted claims that there is inappropriate use of CPT codes 96401-96549 for Chemotherapy and other highly complex drug or highly complex biologic agent administration.” The current LCA from Noridian: Local Coverage Article: Billing and Coding: Complex Drug Administration Coding (A58532) no longer contains a list of drugs permitted to be billed with a chemotherapy code. Although not stated, we suspect that the MACs will determine the appropriate use of chemotherapy administration codes based upon the medical record documentation rather than a “pre-approved” listing of drugs. Consequently, complete medical record documentation meeting the detail of the CPT codes will be even more important to substantiate chemotherapy drug administration services billing in the outpatient setting. SHOUT-OUTS 1. Coding Teams should be made aware of this procedural change in instruction from the MACs and ensure that billing with chemotherapy administration codes is substantiated by documentation in the patient’s medical record. 2. Revenue Integrity should review any “hard-coded” logic that may have automated the process for billing chemotherapy administration codes with the previously listed drugs to ensure that chemotherapy administration codes are not inadvertently billed based upon the drug name alone. 3. Revenue Integrity should periodically audit a sample of claims bil

46 // Back to Flu Season

07-26-2021

It’s that time of year again when school supplies are purchased and flu shots are given. A silver lining of the Covid-19 pandemic, flu transmission was relatively low in the...

45 // What, No Changes? OPPS CY2022 Proposed Rule Summary

07-26-2021

The Centers for Medicare & Medicaid Services (CMS) provided the Proposed Rule for CY2022 for the OPPS System on July 20, 2021. This document is scheduled to be published in... the Federal Register on 08/04/2021. Comments are due to CMS on September 17, 2021. The good news is there aren’t major changes for drug reimbursement. We’ve recapped the majority of the drug-related issues here. 1. Claims Data- Typically claims data from 2020 would be analyzed for determining payment starting January 1, 2022. However, due to the pandemic, CMS is exercising its authority and will use data from 2019 claims similar to what was proposed in the Inpatient Prospective Payment Proposed Rule for FY2022. 2. Pass-through expirations CY 2021- 25 drugs had/will have pass-through payment expire between March 31, 2021 and December 31, 2021. These are listed in Table 27 (page 266 pdf) 3. Pass-through expirations CY 2022- 26 drugs will have pass-through payment expire during CY2022 in Table 28 (page 270 pdf) 4. Pass-through extensions- Due to the pandemic, CMS is using its equitable adjustment authority to provide up to four quarters of separate payment for 27 drugs and biologicals whose pass-through payment status will expire between December 31, 2021 and September 30, 2022. These drugs are listed in Table 33 (page 324 pdf). 5. Packaging Threshold- CMS proposes to continue the per-day cost packaging threshold for separate payment at $130. 6. 340B- CMS has proposed to continue lower reimbursement for 340B-purchased, non pass-through-drugs. Instead of the ASP+6% reimbursement for separately payable drugs, CMS will continue to reimburse at ASP-22.5%. Modifiers “JG” and “TB” will still be required. CMS explicitly states that any changes to the current 340B payment policy would be adopted through public notice and comment rulemaking. 7. Biosimilar- CMS proposed to continue its current policy to make all biological products eligible for pass-through payment and not just the first biosimilar product for a reference product. CMS will also continue its payment policy of paying non-pass-through biosimilars acquired under 340B at the biosimilar’s ASP-22.5% of the biosimilar ASP (and not the reference product ASP). 8. Non-opioids-CMS will continue to provide separate payment for two drugs in the ASC setting as non-opioid pain management drugs that function as supplies (Exparel and Omidria). However, CMS is proposing a regulatory text change to require that these and any additional non-opioid drugs have FDA approval, be approved for pain management or analgesia and for the drugs to have a per-day cost in excess of the OPPS drug packaging threshold, which is proposed for CY 2022 at $130. CMS has asked for comments on whether the current policy of paying separately at ASP+6% in the ASC setting should be extended to the HOPD setting where they currently are packaged payment (unless designated as pass-through status). Hope this summary is helpful in evaluating your reimbursement for the coming year! SHOUT-OUT 1. All pharmacy revenue cycle teams should review the Proposed OPPS CY 2022 Rule and provide any comments to CMS by September 17, 2021.

44 // ASP Calculations and Self-Administered Drugs

07-20-2021

Did you notice the decrease in payment rate in abatacept and certolizumab in the July 2021 quarterly update? They decreased by 22% and 19% respectively, but did you dive into... the details? Changes in payment rates are difficult to track and understand their correlation with the ASP value and the price in which your organization may pay for the drug. ASP values are calculated based on submission of sales price net any price concessions (e.g. volume discounts, prompt pay, cash discounts) by the manufacturer during the quarter and generally have a two quarter lag. Manufacturers submit the information by NDC, and CMS then later crosswalks the NDC to the HCPCS. The Social Security Act requires that payment be determined without regard to any special packaging, labeling, or identifiers on the dosage form or product or package. The OIG published a report in November 2017, “Excluding Noncovered Versions When Setting Payment for Two Part B Drugs Would Have Resulted in Lower Drug Cost for Medicare and its Beneficiaries”, and determined CMS interprets the inclusion of NDC for ASP calculation to include: 1. All versions of the drug listed under the FDA approval number (e.g. NDA, BLA) must be considered the same drug or biological for payments made under Section 1847A of the Act, and 2. For a product marketed under the same approval number, labeling that indicates that a version may be used primarily when the drug is not covered under Part B cannot be used as a basis to exclude that version from a payment amount calculation. The OIG evaluated Orencia and Cimzia as having both an IV formulation that would be given as an infusion and a subcutaneous formulation generally self administered. During the time period of 2014-2016, the price of the two drugs was largely driven by the self administered formulation though CMS made payments only on the IV formulation covered under Part B. Had CMS not included the self administered formulation in its ASP/payment calculation it would have saved Medicare and its beneficiaries $366 million over 3 years. Fast forward in time and the country became overwhelmed by the Covid-19 pandemic, and the “Consolidated Appropriations Act of 2021” was signed into law. This legislation was fill ed with relief funding for Covid-19 among other things that overshadowed the section “special rule for determination of ASP in cases of certain noncovered self-administered drug products”. The legislation amended 1847A of the SSA by determining the payment amount, the lesser of the amount calculated using the current formulation or the calculated amount excluding self-administered drugs thus resulting in the decrease in payment for abatacept and certolizumab. Shout Outs! 1. Revenue Integrity and Pharmacy it is time to revisit routine and new regulation to ensure you and your teams have not missed any information. 2. Pharmacy teams to be aware of other drugs that may have an infusion and self-administered formulation and monitor for the impact in revenue and other contracting arrangements. 3. Pharmacy team to evaluate the quarterly payment changes to ensure your formulary is optimized with the cost vs. reimbursement structure. Sign up for our Newsletter!

43 // Take-Home Meds: To Bill or Not to Bill

07-12-2021

The past few years have seen an increase in “Take-Home Meds” Programs. There are specific billing rules that apply to Medicare patients with Part A, B and/or D coverage who... opt to receive “Take-Home Meds”. Inpatients If only a limited supply is needed to cover the time from discharge until an inpatient can get a prescription filled in a network pharmacy, hospitals are permitted to dispense a limited supply and include it in the Part A (inpatient) claim (and not bill Medicare Part D or the patient). Chapter 1, Section 30.5 Drugs For Use Outside the Hospital in the Medicare Benefit Policy Manual contains the following: “Drugs and biologicals furnished by a hospital to an inpatient for use outside the hospital are, in general, not covered as inpatient hospital services. However, if the drug or biological is deemed medically necessary to permit or facilitate the patient’s departure from the hospital, and a limited supply is required until the patient can obtain a continuing supply, the limited supply of the drug or biological is covered as an inpatient hospital service.” A patient does not need to have Part B or Part D coverage to receive this limited supply when being discharged from an inpatient status. Providers are encouraged to document the drugs dispensed to the patient noting that they were necessary to “permit or facilitate the patient’s departure.” Outpatients Take-home medications for outpatients (including observation and emergency department patients) completing their stay are subject to the October 2015 OIG policy. Although hospitals may waive or discount self-administered drugs that are provided for ingestion or administration while the patient is an outpatient of the hospital, the same discounting does not apply to medications which are provided as a “take-home” medication. (Note: A beneficiary is not considered an outpatient if the only service received from the hospital is the dispensing of a drug for subsequent self-administration). There are no provisions for protection from Federal anti-kickback, fraud and/or abuse statutes for a patient to receive a “limited supply” after an outpatient encounter without billing to the Part D insurance and/or beneficiary. SHOUT-OUTS! When developing “Take-Home Meds” programs, hospital pharmacies should identify the status (inpatient vs. outpatient) of Medicare patients to determine options available to provide the patient with a “limited supply” or a full prescription of medication upon discharge. Pharmacy and Revenue Integrity should ensure that a “limited supply” of medications to facilitate a discharge is added to the inpatient Part A claim and not billed to Part D insurance or the beneficiary and that an appropriate notation is included in the medical record. Pharmacy and Revenue Integrity should ensure that for Medicare outpatients, either a limited supply of “take-home” medications or a full prescription must be billed to the Part D plan and/or beneficiary. Medicare outpatients may include observation patients and emergency department patients.

42 // Cetuximab (ERBITUX): New Dosing Regimen exceeds MUE value

07-05-2021

We’ve previously written about Medically Unlikely Edits (MUE) published by CMS and how to appeal them on an individual patient case basis. This article also pertains to MUE values but... outlines a different process to ensure that clinically appropriate drugs are reimbursed for Medicare outpatients and uses a new dosing regimen for Cetuximab (Erbitux®) as an example. Background Cetuximab is a chemotherapy agent approved for patients with K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). On April 6, 2021, the FDA approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for ERBITUX (cetuximab). This approval provides a biweekly dosage regimen option in addition to the previously approved weekly (QW) dosage regimen (initial dose of 400 mg/m2 as a 120-minute intravenous infusion, and subsequent doses of 250 mg/m2 infused over 60 minutes once weekly) as a single agent or in combination with other chemotherapy. The HCPCS code for cetuximab is J9055-injection, cetuximab, 10 mg and currently has an MUE in the April 2021 and July 2021 tables of “120”. After publication of the July 2021 MUE tables on the CMS website, we corresponded with the NCCI Coordinator to request that the MUE value be raised from “120” to “150” to accommodate this new dosing regimen. In addition to convenience for the patient, the new dosing regimen may also decrease the amount of drug wasted. A copy of our letter is here. We are pleased to have received a response on June 28th indicating that they have reviewed and accepted our request and will be increasing the MUE to “150” in a future quarterly update. Until that update is finalized, we recommend that all claims for J9055-injection, cetuximab, 10 mg be reviewed and when the current MUE of “120” is appropriately exceeded, that pertinent information from the patient’s medical record (e.g. physician diagnosis, drug order, BSA calculation, MAR, documentation of discarded waste (if any)) be included with the original claim submission to ensure a medical review at the MAC to avoid a denial. A template letter that can be included with your submission is here.. What can you do if dosing regimens for other drugs also change the MUE in the future? Contact us through the CONTACT US page of the website and we’ll send the letter to the NCCI contractor for review. You can also submit a letter to NCCI asking for a review. SHOUT-OUTS! Pharmacy should identify trends when new dosing regimens are used to ensure that MUE values are not appropriately exceeded. Pharmacy and Revenue Integrity should collaborate when FDA labeling changes occur to ensure that MUEs are not exceeded. If they are, the initial claim submission for the full amount of drug utilized should be billed and a copy of pertinent portions of the medical record submitted with the claim submission. When new dosing regimens are exceeded, Pharmacy and Revenue Integrity should consider submitting a requester to the NCCI contractor to increase the MUE, or contact PHARMACY REVENUE CYCLE to submit the letter to request the increase.

41 // July 2021 CMS Quarterly Updates

06-28-2021

In order to foster innovation and expedite adoption of and patient access to new medical technologies, CMS has implemented a quarterly HCPCS code application opportunity for drugs and biological products... while other procedures are on a bi-annual application opportunity. Quarter 3, 2021 is packed with a bang and we have evaluated the key elements and a process for breaking down drugs and biologicals. There are a couple places in which you can find this information including the published transmittal (1082) and MLN matters (MM12316) which provide the information in a narrative form and by going to the tables directly and extracting from the CMS quarterly update page. A section within the MLN or transmittal will be labeled “Drugs, Biologicals, and Radiopharmaceuticals” and generally outlines four major changes including new or modified HCPCS and their descriptor, changes in status indicator, changes in payment rates, and restated payment rates. New HCPCS New HCPCS include 9 drugs and biologicals that have not previously been specified codes and will receive pass-through status (SI, G). These drugs previously may have required the use of C9399 or other non specified code if used. Two new HCPCS codes that are replacing temporary codes that are being discontinued. One new HCPCS code not eligible for pass-through status Two radiopharmaceuticals that will appear with a SI of G due to a late correction, but CMS will make a retroactive change to SI of N and no separate payment will be made. 2. Changes in status indicator Six HCPCS codes that will expire their pass-through status effective 6/30/2021 and will move to a non-pass through status (SI, K). J3399 (Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5×10^15 vector genomes) will change from a status indicator of K to A. This means it will no longer be paid under OPPS rather each MAC will require a manual adjudication utilizing a fee schedule or other payment methodology other than OPPS. See addendum D1 for definitions of each status indicator. 3. Changes in payment rates based on average sales price (ASP) ASP values are updated quarterly as well. Conduct an evaluation by comparing previous quarter ASP to the update. Table below displays separately payable drugs and biologicals with more than a 20% change in ASP. 4. Restated payment rates In a previous Pharmacy Revenue Cycle News, “Back to the Future: Restated Drug and Biological Payment Rates”, we discussed the importance of evaluating the restated payment rates. It is up to each organization to assess the payment difference and determine if there is an impact and rebill each claim. 5. New COVID-19 Vaccine and Administration codes Three new CPT codes for the Novavax Covid-19 vaccine are published and will have an effective date equal to that of the FDA Emergency Use Approval (EUA) or approval. Lastly, the July quarterly update also announces several other changes that have already gone into effect but reinform readers that the updates have been made in the I/OCE. COVID-19 vaccine and administration code revisions to the I/OCE Bamlanivimab and administration of Bamlanivimab codes will be deleted. Please reference our previous newsletter on “Covid Infusion Confusion”. The I/OCE has been updated with the monoclonal antibody HCPCS with the respective effective dates and the APC assignment from 5694 (level 4 drug administration) to 1506 (New Technology – Level 6). This increased the payment of the administration of casirivimab and imdevimab (M0243) and bamlanivimab and etesevimab (M0245). Two new codes, M0244 and M0246, representing administration of casirivimab with imdevimab and bamlanivimab with etesevimab in the home settings have been updated to APC 1509 (New Technology – Level 9) further increasing the reimbursement.

40 // Revenue Codes

06-21-2021

The National Uniform Billing Committee (NUBC) was formally organized in May 1975 and develops and maintains the UB-04 (uniform billing) data set used by the institutional health care community. The... NUBC is one of four organizations recognized in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for a special consultative role around the development and adoption of administrative transactions for the electronic exchange of health information. One of the primary responsibilities of the NUBC is to maintain and update the revenue codes used by institutional providers for billing. Revenue codes are not used on physician claims but are required on institutional claims. Typically, the revenue code indicates what department or place a procedure or treatment is performed, such as the emergency room, or operating room. However, drugs can be used in multiple locations, so the revenue codes pertaining to pharmacy (025x, 063x, 089x) describe drugs, biologicals and radiopharmaceuticals independent of where they are administered in the facility. It should be noted that these revenue codes are used exclusively for products labeled by the FDA as drugs, biologicals or radiopharmaceuticals and are not to be used to bill other products that a pharmacy may provide such as medical devices, supplies, or dietary supplements. It is a facility decision whether or not to bill these items under a non-pharmacy revenue code. Revenue codes are four-digit codes that begin with a “zero”. Let’s take a closer look at the most common revenue codes used for drug products. The 089x range is a new range where 0891 represents CAR T-cell therapy and 0892 represents Gene Therapy. The FDA maintains a list of approved cellular and gene therapy products that can be used to identify these products. In the 063x range, the most commonly used revenue code is 0636- Drugs requiring detailed coding. This revenue code cannot be billed without a valid HPCPS/CPT code. Another common revenue code is 0637-self-administrable drugs. The use of this revenue code indicates to CMS that the provider understands that there is no coverage under Part B, but the charges are being reported for information only, or so that CMS acknowledges the coverage status for potential billing to another insurer or the patient. In the 025x series, the most common pharmacy-related revenue codes are 0250- General and 0253-Take home drugs. Revenue code 0253 is used when drugs are given to the patient after a visit for the patient to take at home. This revenue code is also not covered under most circumstances and the charges are billed to a patient as a routine ambulatory prescription. Revenue code 0250 is used for all other drugs and biologicals when no HCPCS/CPT code is available for billing but where CMS coverage exists. Two other revenue codes may be used by pharmacy when setting up billing: 0343 and 0344. These codes are used to identify radiopharmaceuticals with 0343 designating diagnostic radiopharmaceuticals and 0344 designating therapeutic radiopharmaceuticals. Why are revenue codes important? One important aspect is determining whether a charge is covered by a payer. For example, CMS does not cover self-administered drugs, so listing a product on a claim with revenue code 0637 is an indication that the provider doesn’t expect to be paid for the product. It is important that the Managed Care contract negotiation group understand which products are reported in which revenue code and ensure that contracts are written to capture additional reimbursement for high cost drugs. For example, revenue code 0636 is often referenced in contracts to indicate an additional “drug carve-out” payment on outpatient claims. Failure to list drugs with HCPCS/CPT codes that meet payer criteria can result in lost payment if they appear on the claim in revenue code 0250. It is also important that medical devices and dietary su

39 // COVID Infusion Confusion

06-13-2021

The monoclonal antibody infusions may seem like old news at this point, especially as mask restrictions loosen and Covid-19 fears decrease. However, healthcare workers continue to battle the Covid-19 and...

38 // When is a Unit not a Unit?

06-07-2021

Well, a unit is not a unit when you are measuring human plasma-derived blood factors that are used to treat both Hemophilia A and Von Willebrand disease (VWD). Alphanate®, Humate-P®,...

37 // 340B Medicare Modifiers

05-01-2021

The interdisciplinary team collaboration between financial/revenue cycle team members and operations is increasingly important. The implementation of the Medicare billing modifiers and payment implications on 340B purchased drugs highlighted this... need for many organizations. Beginning January 1, 2018 CMS Outpatient Prospective Payment (OPPS) finalized payment reductions and billing modifier requirements for select entities who purchase drugs under the federal 340B pricing program and furnish to Medicare beneficiaries by a hospital who are paid under the OPPS. The organization is required to bill each drug line with the appropriate modifier to ensure proper payment. Modifier “JG” Drug or biological acquired with 340B drug pricing program discount Modifier “TB” Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes While the TB modifier is informational; it is required on OPPS claims (bill type 13X) for all applicable providers. JG modifier is considered a payment modifier and signals a reduction in payment to ASP-22%. Understanding some key elements (explained in the table below) may help simplify the ruling to determine how an organization should apply the modifiers and when payment reduction occurs (JG). The table below excludes vaccines as they are not eligible for 340B discounts and application of a JG or TB modifier does not apply. Additionally, CMS does not pay for packaged drugs separately; thus, the application of the JG or TB modifier is optional and excluded from the table. Table is adopted from CMS FAQ and updated based on 2021 HOPPS Final Rule JG and TB modifiers should be applied in addition to other required modifiers. Highlighted are some scenarios in which JG or TB modifiers may be billed in addition on a single drug line. Waste requires the application of a “JW” modifier “PN” or “PO” modifiers are required for off campus provider based departments “EA”, “EB” or “EC” modifiers are required for billing erythropoiesis stimulating drugs (ESA) Dual-eligible beneficiaries based on the state Medicaid program may require “UD” modifier when billing 340B purchased drugs SHOUT-OUTS! Revenue integrity and pharmacy teams should review their process for applying the appropriate JG or TB modifier. New drugs routinely enter the market, while other drug’s pass-through status may expire on a quarterly basis. It is important to continually update the application of the JG or TB modifier to prevent potential over- or underpayments. Pharmacy teams should take into consideration payment reduction on applicable 340B purchased drugs when performing financial analysis or formulary consideration. Review along with previous newsletter addressing pass-through status.

36 // Payment for Hemophilia Factors: Inpatient and Outpatient

05-24-2021

In recent newsletters, we’ve outlined some scenarios where drugs used on inpatients receive extra payment in addition to the MS-DRG reimbursement. Two examples are for hemophilia factors and drugs designated... for 2-3 years of new technology add-on payments. However, some drugs receive separate payment because the inpatient claim is coded differently and results in a higher-reimbursed MS-DRG. Let’s look at the scenario when tPA is administered to a stroke patient in the Emergency Department and then the patient is admitted. Although the tPA may be administered in the ED when the patient still has a status of outpatient, when the patient is admitted, all the outpatient charges must be combined and reflected on a single, inpatient claim (Three Day Payment Window). However, when we look at the MS-DRG reimbursement structure, we see that the cost of TPA is accounted for through the inpatient payment system (IPPS). The MS-DRG payment is calculated as the relative weight of the MS-DRG x hospital blended rate. Relative weights and hospital-specific rates are recalculated annually. The hospital blended rate is based upon many factors including urban vs. rural location, wage variations, teaching hospitals, and the disproportionate share of financially indigent patients. The actual payment for the same MS-DRG will vary between facilities based upon these and other variables (e.g. readmission rates). Let’s look at our scenario of tPA administration in the ED with subsequent inpatient admission. The DRG listing for stroke for FY2021 is MS-DRGs 061-066. Available in Table 5 of the FY2021 IPPS Rule are the relative weights for each MS-DRG: A full list of DRGs is available at: https://www.cms.gov/icd10m/version39-fullcode-cms/fullcode_cms/P0002.html In our example, let’s take a hospital whose blended base rate is $7,626.99 and compare the compensation for MS-DRG 63 vs. MS-DRG 66. MS-DRG 63 (no complications; received tPA) = $7626.99 x 1.7099 = $13,041.39 MS-DRG 66 (no complications; no tPA) = $7626.99 x 0.7109 = $5,422.03 The payment difference is around $7600+ The revenue reflected in a higher payment due to a different MS-DRG may be difficult to correlate with the direct expense incurred by pharmacy for the tPA since the difference in reimbursement will not be itemized on the Remittance Advice (RA) returned from the payer. Since these are inpatient claims, the individual HCPCS code for tPA will not be listed. Instead, HIM coders would put these ICD-10-PCS codes on the inpatient claim to identify those patients who received the thrombolytic so that a different MS-DRG will be reimbursed. SHOUT-OUTS! 1. Pharmacy and Finance should determine which drugs may result in higher MS-DRG patients when administered to inpatients. 2. Education should be provided to HIM coders as to where documentation for these drugs may be located in the patient’s medical record (e.g. Emergency Department record, Radiology notes, Medication Administration Record). 3. When drugs result in additional inpatient reimbursement based upon a higher relative weight for the MS-DRG, Pharmacy and Finance should incorporate the additional revenue into financial calculations when evaluating drug costs. As the reimbursement for the tPA will not be itemized on the Remittance Advice (RA), a separate financial calculation should be developed correlating the drug cost for the tPA and the additional revenue received.

35 // Payment for Hemophilia Factors: Inpatient and Outpatient

05-17-2021

Coverage Inpatient The Social Security Act (Section 1886(a)(4)) provides that hospitals receive extra payment for the costs of administering blood-clotting factor to Medicare hemophiliacs when they are hospital inpatients. Payment... is based upon a price per unit of clotting factor multiplied by the units provided. Medicare provides coverage for these factor products through Part A (inpatient) and B coverage (‘incident to’) and self-administered products when the patients are competent to use the factors without medical supervision. Medicare covers blood-clotting factors for the following conditions: Factor VIII deficiency (classic hemophilia, hemophilia A). Factor IX deficiency (hemophilia B, Christmas disease, plasma thromboplastin component). Congenital factor XI deficiency (Hemophilia C). Von Willebrand’s disease. Acquired hemophilia (acquired Factor VIII autoantibodies most frequently) and other coagulation factor deficiencies, intrinsic circulating anticoagulants, antibodies or inhibitors. Congenital deficiencies of other clotting factors (such as congenital afibrinogenemia and others). It is important to note that under Part A (inpatient), these are the only diagnoses that are eligible for add-on-payment. The FDA label may list additional diagnoses for the products but they are not separately payable under Part A; payment will be included in the MS-DRG payment. Outpatient For Part B (hospital outpatient, physician office), Medicare reimburses based upon HCPCS code and ASP pricing file and an annually updated ‘furnishing fee’. The ASP and Addendum B quarterly updates include the ‘furnishing fee’. MACs are instructed to add the furnishing fee to any blood clotting factors that are billed under a ‘not otherwise specified code’ requiring manual pricing by the MAC. In general under Part B, all FDA-labelled indications are covered, and those off-label uses that are supported by CMS-authorized compendia or significant published literature. Charging Most blood clotting factors are supplied as lot-specific products; each vial may have a different amount of active factor within a stated range. Providers are invoiced for the actual amount purchased, and therefore can only bill for that amount. For example, if a vial contains 484 units of Factor 8, it would not be appropriate to bill for 500 units even though it may be listed in a wholesaler catalog as a “rounded amount”. Billing in rounded increments often results in claims audits that result in payment refunds when the medical record substantiates a different amount was administered to the patient than the amount that was billed. Billing Both inpatient and outpatient claims require the blood clotting factor be listed by HCPCS code in revenue code 636 with the number of units administered to the patient. In general, inpatient claims remove the HCPCS detail and sum all charges per revenue code. When this occurs, the blood clotting factors may need to be added back to the inpatient claim so that appropriate payment can be calculated. Novitas Solutions, Inc. has provided detailed instructions for billing Hemophilia Factor products including guidance on billing for products when the dose administered exceeds the Medically Unlikely Edit (MUE) established for that HCPCS code. Novitas instructs that a maximum of 9999 units should be listed for each line. If the billing exceeds 9999 units per date of service, or exceeds the MUE established for that HCPCS code, subsequent lines should reflect the remainder of the units with modifier -76 (repeat procedure). An example is provided in the Novitas Local Coverage Article #56433. Blood Clotting Factors which generate additional inpatient add-on payment are designated on the ASP Pricing File which is updated quarterly. Column I, “Clotting Factor” contains a “1” for products which are eligible for reimbursement. A list of current designated clotting factor

34 // Did you mean to say EAPG?

05-12-2021

EAPG or the Enhanced Ambulatory Patient Grouping is among the models focused on transitioning fee for service to a value based payment. Over 25% of the state Medicaid programs in... addition to several commercial payers have adopted the EAPG outpatient prospective payment system. 3M developed the methodology to provide greater uniformity in payments across multiple diverse outpatient areas and designed to represent all patients, not just Medicare. There are 8 EAPG types that are assigned to each claim line to classify the services in a visit. The classification or logic is based on the presence of an APG (ambulatory procedure group), diagnosis codes, clinical signs and symptoms, and other ancillary tests. This form of classification is more complex and includes clinical variables within the visit than the traditional APC (ambulatory payment classification) system used by Medicare. EAPG Types Significant procedure, therapies, test Ancillary services Incidental procedures Medical Visits Drugs Durable Medical Equipment Per Diem Unassigned Once the EAPG is assigned it will pass through grouper functions that may apply pricing types including: full payment, consolidation, packaging, discounting or per diem to each individual line. Consolidation occurs when 2 or more significant procedures or clinically similar procedures are billed and only the primary or EAPG with highest weight receives full payment. Packaging occurs when ancillary services are used and considered to be part of the procedure, and discounting is payment receiving less than full payment. Each state Medicaid program or insurer that utilizes the EAPG methodology will develop the organization’s base rate and may have some variances in how they determine what is consolidated, packaged or discounted. Base rates may be determined based on cost to charge ratio or have other formulas based on regional variation. Final payment then applies the following formula: base rate x EAPG weight x policy adjuster (e.g. modifiers) x discount factor = payment. Base rates and relative EAPG are typically published on Medicaid portals; however, crosswalks of HCPC to EAPG are not publicly available and should be sourced through 3M. Shout Outs! Billing and revenue integrity teams should take some time and training to understand the implications of billing. Application and acceptance of modifiers and other billing requirements not addressed in this article may vary from traditional Medicare guidelines. Revenue cycle and pharmacy teams should monitor payment from programs that utilize an EAPG methodology. High cost drugs entering the market may or may not be built within the EAPG methodology accurately resulting in revenue leakage.

33 // Off-label Use and Reimbursement

05-04-2021

When the Food and Drug Administration (FDA) approves a drug for sale in the United States, the approval includes a section entitled “Indications for Use.” This section lists the one... or more diseases, conditions, or symptoms for which the drug’s sponsor (usually the manufacturer) has provided, to FDA’s satisfaction, evidence in support of the drug’s safety and effectiveness. Prescribing for these parameters is considered “on-label” or “labelled” uses. The FDA traditionally has not regulated the practice of medicine and therefore physicians may prescribe an FDA-approved drug for indications not listed in the official FDA-approved labels. This is considered as “off-label” or “unlabeled” use. Credible researchers have estimated that off-label use makes up as little as 12% or as much as 38% of office prescriptions, and up to 50% for anti-cancer drugs. When and how are off-label uses reimbursed by Medicare for Parts A and B? If Medicare has issued a National Coverage Determination (NCD), Local Coverage Determination (LCD), or other Medicare instruction, providers must follow the guidance to determine coverage. For example, NCD 110.24- National Coverage Determination (NCD) for Chimeric Antigen Receptor (CAR) T-cell Therapy indicates that coverage is for “FDA-approved indication, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.” What are the CMS-approved compendia for cancer drugs? CMS has established five drug compendia as authoritative sources on drug benefit category for cancer drugs. The approved compendia are as follows in no particular order. American Hospital Formulary Service-Drug Information (AHFS-DI) National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium Micromedex DrugDex Clinical Pharmacology Lexi-Drugs What about coverage for non-cancer drugs? CMS has addressed anti-cancer drugs in their internet-only manuals, but the MACs have provided direction for all drugs. This excerpt is from Noridian: Determination of approved and accepted off-label drug indications: For all drugs, including anti-cancer drugs, and in the absence of any statutory, CMS, or MAC exclusion of any drug or specific drug indication, Medicare recognizes an indication to be medically accepted if the indication is both: FDA-approved for the drug at the FDA published dose and frequency; or Listed in one or more of the approved compendia with an appropriate level of evidence of efficacy (see below); or Recognized, following Medicare’s review of the peer reviewed literature, as an appropriate treatment: (The requestor is expected to provide significant peer reviewed full articles to the Contractor for review) AND The use is not listed as unsupported, not indicated, not recommended (or equivalent terms) in any of the compendia. Any such listing precludes reimbursement for the drug. “Medically accepted” definitions by compendium: NCCN: The level of evidence for the indication is Category 1 or 2A. (If a provider chooses to use NCCN level 2B in support of a chemotherapeutic drug used for an off-label indication, the MAC expects that the provider will make available to the MAC significant peer reviewed phase II or phase III studies demonstrating such support.) DrugDex: The level of evidence for the indication is a Class I, Class IIa, or Class IIb. AHFS-DI or Clinical Pharmacology: The narrative text is supportive. Lexi-Drugs: The indication is listed as “Use: Off-Label” and rated as “Evidence Level A.” Not “medically accepted” by a compendium: NCCN: The level of evidence for the indication is Category 3 in NCCN. DrugDex: The level of evidence for the indication is Class III in DrugDex. AHFS-DI or Clinical Pharmacology: The narrative text is “not supportive” (or equivalent term). Lexi-Drugs: Indication is listed as “Use: Unsupported.”

32 // tPA-Drip anTime is Money – Diving into the details of Pass-Through Status

04-26-2021

Drugs continue to enter the market at a fast rate with a heavy price tag. This is complimented with lightning speed information flow directly to providers and patients creating a... quick uptake in the utilization. “Time is money”. This phrase has stood the test of time and is more important to consider in the evaluation of the pharmacy revenue cycle. CMS provides temporary or transitional pass-through payment for certain drugs, biologicals and radiopharmaceuticals as indicated in the Social Security Act Section 1833(t)(6). For the purposes of pass-through, radiopharmaceuticals are included as “drugs”. The following outlines at high level some of the key elements to transitional pass-through payment. This is not all inclusive and should refer back to the act for more details. An application must be submitted to CMS for approval of pass-through status Service is provided in a covered hospital outpatient department Service provided is not comparable to another group clinically and with respect to the use of resources to another category Drug is “new” and whose cost is not insignificant in relation to the associated OPPs payment for the procedure Pass-through payment will be made for at least 2 years, but not more than 3 years Pass-through payment applications are accepted on a quarterly basis and will expire quarterly to grant pass-through payment for as close to 3 years as possible (previously expiration occurred annually) Pass-through drugs are assigned a status indicator of “G” in Addenda A and B Payment is based on the ASP methodology and may use a basis of ASP, WAC, or AWP depending on data availability Pass-through status often creates confusion around biosimilars as this language has changed throughout the last five years. In CY2016 and 2017, biosimilars were included in their reference product HCPCS assignment and not subject to pass-through status. Upon the finalizing CY2018 Hospital Outpatient Prospective Payment, biosimilars were granted a separate HCPCS code and became eligible for pass-through status. Thus, each new biosimilar that enters the market regardless if it is not the first biosimilar in the category will be assigned a unique HCPCS code and is eligible to receive pass-through payment. Shout Outs! Pharmacy teams should monitor for new and expiring drugs with pass-through status. Pass-through status may aid in a formulary decision when assessing financial impact taking special consideration for biosimilars. Revenue integrity teams should monitor for new and expiring drugs with pass-through status and the associated change in status indicator. In select 340B eligible organizations, this change will drive changes in billing modifiers. (To be discussed in more detail in future article)

31 // tPA-Drip and Ship-Additional Reimbursement for Receiving Facilities

04-19-2021

An important element in the American Heart Association’s, “Get with the Guidelines-Stroke“ is that tPA should be administered within 4.5 hours of the first sign of stroke to dissolve the... blood clot, restore blood flow to the impacted area of the brain and reduce disability. “Drip and ship” means that front-line, community hospitals quickly administer tPA to people suffering an ischemic stroke, and then immediately transport them to a comprehensive stroke center. The front-line community hospital typically treats the patient in the Emergency Department, administers tPA and prepares the patient for transport. The community hospital will bill an outpatient ED claim including the HCPCS code for the tPA (J2997- Injection, alteplase recombinant, 1 mg), CPT codes for the administration of the bolus/infusion of the tPA and any additional services provided prior to transfer. The receiving hospital will admit the patient and assume responsibility for the patient’s care. Upon discharge, the hospital will bill the admission on an inpatient claim. In addition to services provided while an inpatient, the receiving hospital should also add ICD-10-CM code Z92.82 (Status post administration of tPA (rtPA) in a different facility within the last 24 hours prior to admission to current facility) as a secondary diagnosis. Including this code on the inpatient claim increases the reimbursement for the admission (in addition to the DRG payment). CMS coding guidance indicates that this code should be added even if the patient is still receiving the tPA at the time they are admitted to the receiving facility. Due to the specificity of the code, we recommend the transfer record be included in the medical record of the inpatient admission and that it is review to ensure that the documentation details that the patient received the tPA within 24 hours of admission. It may be difficult to identify these patients since the tPA was not administered at the receiving facility, and therefore J2997 would not be listed on the account. One approach is to review all inpatient discharges with a Point of Origin Code = 4 (Transfer from a hospital (different facility); Inpatient-The patient was admitted to this facility as a hospital transfer from an acute care facility where he or she was an inpatient or outpatient) that also have an ICD-10-CM diagnosis code of Stroke. Point of Origin codes are a required data field on the UB-04 or 837I (electronic equivalent of UB-04). SHOUT-OUTS! 1. Revenue Cycle and HIM should develop a process to identify inpatient stroke patients who received tPA and another acute-care facility prior to transfer. One approach is to review all claims with a Point of Origin Code = 4, and a ICD-10-CM Diagnosis code of Stroke. 2. HIM Coders should review the transfer record to ensure that there is documentation that the patient received tPA at the originating facility and add ICD-10-CM code Z92.82 as a secondary diagnosis which results in additional reimbursement.

30 // CAR T-cell Therapy: Coverage and Billing for Outpatients

04-12-2021

Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to... treat their cancer. This newsletter details coverage and billing instructions when the products are used on an outpatient basis. A future newsletter will provide instructions when used for an inpatient. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a list of approved cellular and gene therapies including five that are Car T-cell therapies: ABECMA (idecabtagene vicleucel) BREYANZI (lisocabtagene maraleucel) KYMRIAH (tisagenlecleucel) TECARTUS (brexucabtagene autoleucel) YESCARTA (axicabtagene ciloleucel) Coverage CMS finalized a National Coverage Determination (NCD 110.24) on Car T-cell therapies on 8/7/2019. The NCD detailed that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when: Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) Used for a medically accepted indication, i.e. for either an FDA-approved indication as detailed in the FDA-approved label for the product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia When the above requirements are not met, the CAR T-cell therapy is non-covered. In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in NCD 310.1. Billing and Reimbursement HCPCS/CPT codes Billing for CAR T-cell therapy on outpatients includes HCPCS codes for the therapies as well as the administration. All CAR T-cell products should be billed with revenue code 891. Kymriah (tisagenlecleucel) is reported with HCPCS code Q2042- Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Yescarta (axicabtagene ciloleucel) is reported with HCPCS code Q2041- Axicabtagene ciloleucel, up to 200 million autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion. Tecartus- (brexucabtagene autoleucel) is reported with HCPCS code Q2053- Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. Breyanzi- (lisocabtagene maraleucel) received FDA approval on 2/5/2021 and Abecma (idecabtagene vicleucel) received FDA approval on 3/26/2021. CMS has not yet assigned a HCPCS code to these new products and we would recommend that these be reported with C9399- Unclassified drugs or biologicals. This HCPCS code is used to report newly approved products prior to HCPCS specific code assignment. The administration of any CAR T-cell therapy should be reported with CPT code 0540T- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. This CPT code should be reported with revenue code 874 – Infusion of Modified Cells w/CPT 0540T. Some payers also require that the claim include a new value code 86 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim. CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples on these two options for CAR T-cell billing for ou

29 // On the Hunt, with TPE

04-05-2021

As Easter Eggs are hunted this weekend, CMS has picked back up their auditing services which were previously slowed due to Covid. The Targeted Probe and Educate (TPE) program is... a way to help you as an organization identify errors and provide one on one help to correct them. The TP&E specifically targets providers or suppliers who have high error claim rates or unusual billing practices and items and services that have high national error rates and are a financial risk to Medicare. Medicare Administrative Contractors (MAC) focus only on providers/suppliers that have been identified as potential risk to Medicare trust funds. If chosen for a TPE audit, you will receive a letter from your MAC. Approximately 20-40 claims will be selected for review and supporting medical records. If claims are determined to be compliant, the organization will not be reviewed for the selected topic for at least 1 year. If there are claims that are denied, you will be invited to a one-on-one education session. You will be given at least a 45 day period to make changes. Then a new set of 20-40 claims will be reviewed for up to 3 rounds allowing time for the organization to improve billing practices. Claims may be appealed throughout this process and any overturned will be taken into consideration in the error rate. Failure to improve after 3 rounds of reviews, the organization will be referred to CMS for next steps which may include: 100% prepay review Extrapolation of error rates from a sample of claims with potential of going back 6 years Referral to Recovery Auditor Initiation of exclusion of proceedings to terminate your Medicare participation Referral to Office of Inspector General for further investigation TPE may also include a targeted review of specific drugs. Some MAC may publish a checklist of common errors that are reviewed; while other MAC provide detailed reasons for denials. For example, denosumab has been a past TPE. Common denials seen with denosumab include lack of documentation to meet medical necessity (e.g. bone scans, indication) and lack of valid physician order with appropriate signature. Shout-Outs! Appeals/Audit teams to be prepared for the audits and work with the appropriate teams to quickly implement improvement processes prior to the next sample of audits. Pharmacy teams should attend educational sessions with the MACs to enhance overall response to the audits and strategy to prevent further billing errors. Continue to self-monitor past reasons for TPE or other prepayment audits to ensure billing systems are set up to minimize risk.

28 // Back to the Future: Restated Drug and Biological Payment Rates

03-29-2021

Each quarter, CMS recalculates the payment rates for drugs based upon data electronically submitted by the manufacturers. Occasionally a manufacturer reports an average sales price (ASP) incorrectly, or CMS makes... an error in blending multiple manufacturer submissions. However when audits occur, or providers request a recalculation, CMS will “restate” payment rates for both hospital outpatient departments and ambulatory surgery centers. These are posted each quarterly at the following CMS Locations: OPPS restated payment rates ASC restated payment rates So, what do we do with these tables? In general, there are usually only a handful of HCPCS codes with changed rates, but sometimes they involve multiple quarters. We’ve taken the April 2021 restated payment rates and compared them to the previous quarters. The columns in red were added from other CMS documents, or are calculated differences. Typically, claims with HCPCS codes with restated payment rates are not automatically re-processed. Providers need to bring the claims to the MACs attention and rebill the claim. Since payment rates can generate additional or lower payments, and there are costs associated with rebilling claims, pharmacy should review with compliance and revenue integrity and establish a policy that establishes a minimum cost threshold or percentage to consider re-billing and it should be uniformly applied for positive or negative changes in reimbursement. For example, some facilities may only do further review if the changes is greater than or less than 10%. In reviewing the April restated payment rates, it appears that most impacted HCPCS codes do not have a significant difference. But let’s apply the same process to the January 2021 update. Again, we’ve matched the long descriptors and original payment rates from other CMS files, but we see a different result! Look at the radiopharmaceutical that is reported with HCPCS Code A9600: Strontium sr-89 chloride, therapeutic, per millicurie. The original payment was around $2000, but the corrected rate is almost $4000, a difference of $2000. And remember this is “per millicurie”. In reviewing the FDA information, the recommended dose of Metastron™ is 148 MBq, 4 mCi, administered by slow intravenous injection (1-2 minutes). So the difference in payment rate from the original payment is almost $8000 per treatment! Although this radiopharmaceutical may not be given often, it illustrates that restated payment rates can be significant! Who in your organization reviews these adjustments every quarter and makes the decision to rebill when the difference is important to the bottom line? SHOUT-OUTS! 1. Pharmacy, Compliance and Revenue Cycle should develop a policy and procedure to establish which team will review the quarterly restated drug and biological payment rate files from CMS and request re-billing when differences are significant. 2. Revenue Cycle should review outpatient claims billed with dates of service between October 1, 2020 and December 31, 2020 for HCPCS code A9600 for potential rebilling to Medicare or any other payer who establishes payment rates based upon Medicare. Rebilling should be done within the payer-established timely filing limits (1 year for Medicare).

27 // Don’t Let Your Revenue Decay For Radiopharmaceuticals

03-22-2021

Advancements in cancer therapy continue to emerge and among those options are radiopharmaceuticals. Radiation therapy has been around for centuries, but radiopharmaceuticals are relatively new, with iodine-131 being the first radiopharmaceutical... to be approved by the FDA in 1951. Today, there are several new therapeutic radiolabeled compounds and isotopes that are causing organizations to pause to ensure charge capture and billing is appropriately addressed due to the increase in usage and cost of these agents. CMS addresses radiopharmaceuticals alongside other drugs and biologicals. Medicare Claims Processing Manual 90.2 directs hospitals to report charges for all drugs, biologicals and radiopharmaceuticals along with the correct HCPCS and billed units that were used in the care of the patient regardless of whether the service is packaged or paid separately. In 2008, the I/OCE required claims with a separately payable nuclear medicine procedure to include a radiolabeled product on the same claim. Similar to drugs and biologicals, radiopharmaceuticals are also eligible for transitional pass-through payment for at least 2 years but no more than 3 years. However, radiopharmaceuticals are further classified into two categories: diagnostic and therapeutic. Diagnostic radiopharmaceuticals that no longer receive pass-through status will become policy packaged into the nuclear medicine procedure. Therapeutic radiopharmaceuticals may continue to receive a separate payment or packaged based on a calculated per day cost. As we referenced in our previous newsletter, NDC requirements are becoming more stringent by the payers and increasingly difficult to manage. Several payers, including state Medicaid programs, have extended this requirement for radiopharmaceuticals. Lastly, it is important to call out that C9399 may only be used to bill new FDA approved therapeutic radiopharmaceuticals and not for those intended for diagnostic purposes. SHOUT-OUTS! CDM and/or IT teams to ensure radiopharmaceuticals are built in the EMR that allow the capture of the NDC, detailed HCPCS and apply the respective multiplier whether that is per millicurie or other dosing unit, or per study multiplier. Nuclear medicine or front end operations ensure processes are established that allow the capture of the radiopharmaceutical along with the nuclear medicine procedure. Validate the process charges for the amount that was used in the care of the patient. Billing teams ensure that claims are reporting NDC when applicable based on payer.

26 // March Madness: Double your money for COVID-19 vaccine administration

03-16-2021

CMS has increased the Medicare payment for administering the COVID-19 vaccine for doses given on or after March 15, 2021. The national average payment rates for physicians, hospitals, and pharmacies... is now $40 to administer each vaccine resulting in $40.00 for single dose vaccines, and $80.00 for vaccines requiring two doses. (This is an increase from previous payment rates of $28.39 for single dose vaccines and $45.33 for two dose vaccines). Note: all rates are geographically adjusted. For currently authorized vaccines, the following CPT codes should be used to bill for the administration. As the product itself is still furnished at no charge from the federal government, no codes should be reported on the claim for the vaccine product unless the provider’s billing system requires a token charge. Please note that although the payment rate is now the same for the 1st and 2nd dose of a two-dose vaccine, the codes used to report the administration are unique and should not be interchanged. As a reminder, these vaccines are authorized under an Emergency Use Authorization (EUA), so condition code 91 should be added to the claim for any COVID-19 vaccines administered on or after February 1, 2021. SHOUT-OUTS CMS has increased the reimbursement rate for COVID-19 vaccine administration to a national payment allowance of $40 per administration for any doses administered on or after March 15, 2021. Specific codes are available to bill for each product, and for products which require two doses there are two unique codes for the first and second doses. There’s a list on website. Don’t forget to add condition code 91 to all claims February 1, 2021 or after that indicates that these services are under an Emergency Use Authorization or EUA. As a reminder, although product codes are available, CMS has specifically instructed that the vaccine codes should not be reported on the claim when the product is provided at no cost. However, CMS recognizes that many provider billing systems require a charge to be submitted, even when a product is provided for free or without charge and then institutional providers must report the applicable drug HCPCS code and appropriate units with a token charge of less than $1.01. Providers cannot charge patients for the vaccine or vaccine administration when provided free from the government. Medicare patients receive COVID-19 vaccinations with no co-pay, deductible, or co-insurance. Medicare Advantage patients’ claims will be billed to Medicare Fee-For-Service through 2021. State Medicaid and CHIP agencies must provide vaccine administration with no cost sharing for nearly all beneficiaries during the public health emergency (PHE) and at least one year after it ends. The COVID vaccine administration will be fully federally funded by law signed by President Biden on March 11, 2021. Some States have also provided supplemental payment for administration to Medicaid beneficiaries. For Private Plans: CMS, along with the Departments of Labor and Treasury, is requiring that most private health plans and issuers cover the COVID-19 vaccine and its administration, both in-network and out-of-network, with no cost sharing during the public health emergency (PHE). Current regulations provide that out-of-network rates must be reasonable, as compared to prevailing market rates, and reference the Medicare reimbursement rates as a potential guideline for insurance companies. In light of CMS’s increased Medicare payment rates, CMS will expect commercial carriers to continue to ensure that their rates are reasonable in comparison to prevailing market rates. For individuals who are uninsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by the Health Resources and Services Administration (HRSA).

25 // Adding a Layer to the Onion – Route of Administration Modifiers

03-09-2021

Billing modifiers are typically two characters composed of either letter or numbers, and a CMS Form-1450 or UB-04 can accommodate up to four modifiers on each CPT (Level I HCPCS)...

24 // Billing for Pharmacists’ Services provided in a Hospital Outpatient Department

03-01-2021

CMS recently provided instructions on how pharmacists services provided in a physician office are billed on a 837P (electronic)/CMS-1500 claim form in the 2021 Physician Fee Schedule Rule published in... the Federal Register on December 28, 2020. (See our newsletter of February 8, 2021). However, there is no written guidance (CMS Rule or Transmittal) specifically addressing how pharmacists’ services provided in a hospital outpatient department should be billed. We’ve received a number of questions particularly involving the billing of anticoagulation monitoring services on a 837I/CMS-1450 claim form when these services are provided as a hospital outpatient clinic visit. We have compiled a list of key elements that should be considered when providing these services so that they are eligible for reimbursement. Please note that this information pertains to Medicare outpatient billing. For other payers, it is recommended that reimbursement rates are negotiated as part of the managed care contracting process and that specific documentation of pharmacists’ services should be agreed upon by both the facility and payer to substantiate the billing of the services provided. 1. The pharmacist must be acting within their scope of practice outlined in State rules and regulations for the state in which the facility provides services. This may include special certification (e.g. North Carolina Clinical Pharmacist Practitioner), and collaborative practice agreements. 2. Some States may have pilot or permanent programs for reimbursement that compensate a pharmacist on a monthly basis for total medication therapy based upon a risk-based member stratification. In general, if a patient has comprehensive MTM reimbursed under a monthly reimbursement to a pharmacist, additional reimbursement would not be available for a specific service such as anticoagulation management in a hospital outpatient department. One example is from Tennessee. 3. Elements of MTMS that are included in Medicare Part D payments cannot be included in billing from a hospital outpatient department for Part B services. For anticoagulation monitoring these services may have already been compensated when the prescription was filled under Part D: screening for potential drug therapy problems due to therapeutic duplication, age/gender-related contraindications, potential over-utilization and under-utilization, drug-drug interactions, incorrect drug dosage or duration of drug therapy, drug-allergy contraindications, and clinical abuse/misuse. 4. HCPCS code G0463 ((hospital outpatient clinic visit for assessment and management of a patient) was created in January 1, 2014 by CMS and replaced Current Procedural Terminology (CPT) Level I Codes 99201-99205 (new patient visit) and 99211-99215 (established patient visit) in the hospital environment for billing Medicare outpatients. Therefore, instead of being reimbursed based on the patient’s condition (acuity) or the types of hospital/nursing services rendered, all clinic visits were now paid a single flat rate. This code is only to be used to represent the hospital’s resources used for the clinic visit. The hospital is not required by CMS to use any specific criteria in determining a level of service since it is paid under a flat rate regardless of the intensity of the service provided. While this code change simplified the aspects of the billing process for hospitals, it did not eliminate the need for detailed clinical documentation. Clinical support staff should continue to document all pertinent information, including services and education provided. The documentation in the medical record should substantiate billing G0463 by the facility to represent overhead expenses incurred by the hospital. Therefore, if a provider is not paid by the hospital either as an employee or under a contracted arrangement, the hospital cannot bill for G0463 on the hospital claim.

23 // What could go wrong? Dealing with an ‘invalid NDC’ charge rejection

02-22-2021

We are hearing from more health-systems that they are receiving an increasing number of charges rejected for an “invalid NDC number”. How can this be? Let’s walk through some history... and then look at the most common reasons for the denial. History: State Medicaid programs began requiring National Drug Code (NDC) numbers on outpatient claims in 2006 based upon a federal mandate from the Deficit Reduction Act of 2005. CMS provided instructions to the States with full implementation by 2008. The purpose was so that State Medicaid programs could include physician-administered drugs from physician offices and hospital outpatient departments in the volume reported to manufacturers for rebates. Some States issued specific instructions on billing including which revenue codes are included (e.g. 636 vs. 250), which products were included (e.g. excluding vaccines and radiopharmaceuticals), and how to convert a 10-digit NDC to 11-digits. Most hospital IT systems required updating in order to accommodate the specific requirements. In addition, to State Medicaid Programs, Medicare Advantage programs for dual eligible (Medicare primary, Medicaid secondary) also began requiring NDC numbers to adjudicate claims. By 2016, some payers were requiring NDC numbers for all lines of business (i.e. commercial, Medicare Managed Care) with varying instructions. Invalid NDC numbers: So, how can an 11-digit number be rejected by a payer as “invalid”? Here are the top reasons: 1. It’s not a drug. Only a “drug” (either prescription or OTC) can have an NDC number according to the FDA. The FDA website includes this statement: Assignment of NDC number to non-drug products is prohibited. So—those products labeled as medical devices (e.g. Healon, Gelfoam) are not drugs and should not be billed under revenue code 25x or 636 as these revenue codes are used for drugs and biologicals only. Your Compliance department may instruct that they can be billed under a supply revenue code like 270 or 272. 2. An oral vitamin is usually not a drug, it is a dietary supplement. Other items may also be considered dietary supplements like Coenzyme-Q. See #1. Based upon facility decision these may be billed as a supply or not billed at all. 3. It’s a drug, but it is “unfinished” or “excluded”. The FDA has created two additional files which list drugs that are not “final” drugs or “excluded” because the manufacturer has failed to comply with statutory requirements to update their on-line drug submissions. NDC numbers in these files are considered to be “unapproved drugs” and therefore not covered by Medicare or other payers. These should not be billed to any payer unless there are specific coverage terms within the payer contract for unapproved drugs. (Note: Drugs authorized under an Emergency Use Authorization (EUA) are still “unapproved”, but CMS provides special billing instructions and condition codes for these products). 4. It’s a drug, but it isn’t listed in the FDA NDC Directory. Payers are using two files to evaluate NDC numbers on claims: the FDA NDC Directory, and the CMS ASP HCPCS-NDC crosswalk. a. The CMS ASP HCPCS-NDC crosswalk is published quarterly. Due to the time lag, new drugs may not appear in the NDC crosswalk for multiple quarters from the time first marketed. b. The FDA NDC Directory is updated daily but also contains a limitation: some manufacturers only report a “carton” NDC and not both a “carton” and “vial” NDC when they are different. This may lead to inappropriate rejections. Payers also have provided conflicting instructions on how to address this limitation. For example Cigna instructs to use the NDC from the “vial administered to the patient”. However, Blue Cross/Blue Shield of Illinois instructs that the “NDC on the box (outer packaging) is recommended.” And United Healthcare recognizes the

22 // Don’t be “SAD”… An Alternative Way to Handle Self-Administered Drugs

02-15-2021

Self-administered drugs (SAD) have been a long-standing controversy when administered in a hospital outpatient setting from the perspectives of a patient, frontline healthcare workers, and billing. “Why does my Tylenol cost... $10 per tablet, but the 1,000 count bottle I have at home was purchased for $3?” This question is often difficult to answer and may lead to unintended operational consequences. SAD is defined as medication that is usually administered by the patient. “Administered” refers to the physical process in which the drug enters the body. Oral, topical, suppositories, and others are typically considered medications that can be self administered by the patient. “Usually” means more than 50 percent of the time for all Medicare beneficiaries who use the drug. “By the patient” refers to the beneficiary themselves excluding caregivers, spouse, etc. It is up to the Medicare Administrative Contractor (MAC) to make an individual determination on the classification of a SAD, the above definitions can be used to apply exclusions to other formulations. Intramuscular medications are presumed to be not self-administered while subcutaneous are presumed to be self-administered. However, when making this determination the MAC also considers if the drug is used for an acute condition making it less likely to be self-administered, and the frequency of the administration. If given once per month, the medication is less likely to be self-administered. Each MAC has listed injectable medications they have deemed to be self-administered and direct links can be found under our resource files. These MAC lists are updated at least annually, but can be updated more frequently. (Links on the resource page were updated 2/15/2021). Drugs that appear to be self-administered drugs based upon route or frequency but are used as an integral part of a procedure or directly related to the procedure are billed to Medicare as a supply and packaged into the payment of the procedure. These drugs should not be billed separately to the beneficiary. Examples include: Sedatives in a pre- or post-operative setting Ophthalmic drops Antibiotics Topicals Contrast media for diagnostic test Other medications that are administered immediately before, during or after a procedure Billing for SAD may be further clarified by each individual MAC or commercial payers; however, Medicare Claims Processing Manual outlines “payment condition 1” representing items and services being billed that are statutorily excluded from Original Medicare. These services, including SADs, do not require any advance liability notices (i.e. ABN) and may be billed as non-covered on the Medicare claim. When a SAD is billed on the claim with other covered services, a GY modifier may be used to represent the noncovered line item. Medicare also accepts any National Uniform Billing Committee approved revenue codes. It is fairly routine that patients will need a SAD during a hospital outpatient visit including observation status and emergency room visits. Markups in these settings are often much higher than what a patient can purchase the drugs for home use. Since Medicare does not cover SADs, this may leave the patient fully responsible for the full “$10 per Tylenol tablet”. It should be noted that these drugs are typically covered under the DRG payment when administered to a patient in inpatient status. Prior to 2015, it was required that a provider bill and make a good faith effort to collect their usual and customary charge for a SAD that are not covered under Medicare Part B due to potential implications of the Federal anti-kickback statute. The Office of Inspector General (OIG) recognized this concern and issued a statement that hospitals will not be subject to OIG administrative sanction if they discount or waive amounts that Medicare beneficiaries owe for noncovered SADs as long as the following is met: The policy only applies to discounts on, or waivers of, the amount the Medicare beneficiary owes for a noncovered SAD The policy must be uniformly applied to all Medicare beneficiaries Hospitals cannot market or advertise the discount/waiver Hospitals cannot claim the discount/waived amount as bad debt Shout Outs! Pharmacy teams should collaborate with the revenue cycle team to categorize or define each of the medications as a SAD. Particularly, when reviewing medications that are primarily given in advance of outpatient surgery (i.e. ophthalmic drops) and integral to a procedure such as a radiology procedure (e.g. oral contrast media).. Chargemaster/billing teams should evaluate to ensure when a SAD is used it is appropriately reflected in the correct revenue code with the GY modifier (if applicable) and represents a non-covered charge. Organizations should make a decision to discount or waive the usual and customary charge for SADs to the Medicare beneficiary. This should be consistently applied to all Medicare beneficiaries. Visit our resource page on Pharmacyrevenuecycle.com for more information regarding SADs including links to the MAC’s SAD lists. (Links updated 2/15/2021)

21 // Billing for Pharmacists’ Services provided in a Physician Office

02-08-2021

The Physician Fee Schedule (PFS) Final Rule was published in the Federal Register on December 28, 2020 and includes instructions on the billing of services provided by pharmacists “incident to”... physicians’ services when provided in the physician office setting (Place of Service Code=11). These services are billed by the physician on a 837P or CMS-1500 claim form. The rule includes the following clarifications: Medication management is covered under both Medicare Part B and Part D. When the services are provided and paid under the Part D benefit, the services are not also reportable or paid for under Part B. Pharmacists fall within the regulatory definition of auxiliary personnel under CFR Title 42 Section 410.26. Payers other than Medicare may consider pharmacists to be a qualified health care professional (QHCP) and provide direct payment, but there is no Medicare statutory benefit allowing pharmacists to enroll, bill and receive direct payment for Physician Fee Schedule (PFS) services. Pharmacists are not among the physicians and QHP’s that can furnish and bill for the 2021 office/outpatient E/M visit codes because levels two through five (99202-99205) are by definition only performed and directly reported by physicians or QHP’s. For example, when time is used to select visit level, only the time of the physician or QHP is counted. Pharmacists may provide services “incident to” the services of physicians or NPP (non-physician practitioners) and they must be an integral part of the service of a physician (or other practitioner) in the diagnosis or treatment of an injury or illness. Pharmacists must provide services under the appropriate level of supervision (direct), and must be acting within their scope of practice and any applicable laws or rules and regulations. When medication management is offered as part of the Part D benefit, Part B payment is also not available for services included in the Medicare Part D dispensing fees: pharmacist’s time in checking the computer for information about an individual’s coverage, measurement or mixing of the Part D drug, filling the container, and physically providing or delivering the completed prescription to the Part D beneficiary screening for potential drug therapy problems due to therapeutic duplication, age/gender-related contraindications, potential over-utilization and under-utilization, drug-drug interactions, incorrect drug dosage or duration of drug therapy, drug-allergy contraindications, and clinical abuse/misuse CPT code 99211 (may not require the presence of a physician or other qualified health care professional and is used when the presenting problem(s) are minimal) may represent services provided by the pharmacist. Code 99211 has a status indicator of “B” in the OPPS and is therefore not recognized for payment in hospital outpatient departments, but is payable in physician office settings. CMS agreed with some commenters that under the general CPT framework, pharmacists could be considered QHPs or clinical staff, depending on their role in a given service. However, CMS reiterated that under the current Medicare law, CMS does not have the ability to pay (or even price) services that are furnished and billed directly by pharmacists. CMS did acknowledge that new coding might be useful to identify particular models of care (e.g. collaborative practice agreements) in the future. SHOUT-OUTS Under current Medicare law, pharmacists may provide clinical services in a physician office setting incident to the professional services or other NPP similar to other clinical staff and within their scope of practice, but the physician or NPP is limited to billing only CPT Code 99211 for these services as levels two through five can only be performed and reported by a QHP. Current Medicare Law does not allow pharmacists’ services to be billed directly to CMS when furnished in a physician office. Services included in the payment of Part D benefits cannot also be billed to Part B and include some medication therapy management services in addition to preparation and dispensing of the drug. Other payers may have different instructions on billing for pharmacists’ services or individual agreements may be negotiated with commercial payers.

20 // It’s Groundhog Time Again… C9399 and Drug Billing with Waste Again…

02-03-2021

In a previous newsletter, we addressed the efforts surrounding billing for drug waste and the importance of applying the JW modifier. Separately, we discussed the importance of billing a FDA approved drug with... a C9399 that has not been assigned a permanent HCPCS. Though it seems intuitive to apply the waste billing logic to a drug coded with C9399, most EMRs are unable to perform this cleanly and may leave you with an area of revenue leakage. First, let us review the elements required to bill for C9399 and drug waste. ✅ HCPCS code C9399 is billed with a quantity of “1” (one) on the claim which is essentially a placeholder. ✅ HCPCS C9399 must also report the National Drug Code (NDC) and quantity administered (expressed in the NDC unit of measure). ✅ Detailed information including, C9399, drug name, NDC, and amount administered, should be entered into the NOTES/REMARKS on the claim. ✅ Discarded waste from separately payable single-dose vials must be recorded in the patient’s medical record. ✅ A separate charge line on the claim with the JW modifier should be reported when billing waste for drugs with a permanent HCPCS (not C9399) unless the payer has alternative instructions. ✅ CMS does not allow for fractional billed units in which case the administered dose may need to be rounded up, and the wasted portion should not exceed the total billed units within the vial uses. The majority of Medicare Administrative Contractors (MAC) do not provide further guidance on how they would like to see the claim when waste is generated from a C9399 except Palmetto GBA. Thus, this leaves you with two options: Option 1: Using one charge line only, report the HCPCS C9399 with a quantity of 1. The NOTES/REMARKS section within a claim should include both the administered and wasted portion reported with the JW modifier. Option 2 (according to Palmetto): Use 2 charge lines, one reporting C9399 reflecting the amount of drug administered to the patient and one line representing the wasted portion including the JW modifier. Both the administered and wasted amount should be clearly explained in the NOTES/REMARKS section on the claim. Shout Outs! Pharmacy teams. Ensure waste is documented in the patient’s medical record if you plan to bill for the waste. Billing teams. Validate that there is a process to capture all drugs with C9399 and record detailed information regarding the administered and wasted portion of the drug in the NOTES/REMARKS section. Revenue Integrity. Payment on a C9399 is a manual process by the MAC and it is important to validate that this is completed accurately for the dose and wasted portion. Pharmacy teams. Monitor the 340B accumulation (if applicable). Depending on how your extracts pull from your EHR, the waste portion may be omitted. Thanks to our readers and listeners for asking these unique questions!

19 // Come One, Come All for the Covid-19 Vaccine

01-25-2021

In addition to back-to-back winter storms predicted for this week in Washington, D.C., President Biden issued a Memorandum on January 20, 2021 for the Heads of Executive Departments and Agencies: “Regulatory... Freeze Pending Review.” In this document, President Biden has directed Agency Directors to “pause” the implementation of pending regulations (unless emergency situations exist) to allow President Biden’s appointees to review and approve the rules. This regulatory “freeze” applies to two rules’ statuses: 1) those regulations that have been sent to the Office of the Federal Register (OFR) but have not yet been published, and 2) those regulations that have been published in the Federal Register but have not yet taken effect. Rules with statutory or judicial deadlines are not included in this freeze. For the first group (those not yet published), the rules are immediately withdrawn from the OFR. For the second group (those published, but not yet implemented), department heads are instructed to consider postponing the rules’ effective dates for 60 days from the date of the memorandum (to March 22) and to consider opening a 30-day comment period. In the memorandum, “rule” is interpreted broadly and includes regulatory actions, guidance documents and substantive actions that may lead to an agency statement of policy. These five rules are drug-related rules that we anticipate will be impacted by the 60-day delay: Implementation of Executive Order on Access to Affordable Life-Saving Medications (Display copy; scheduled to be published in Federal Register on 1/26/2021). Original Rule: December 23, 2020 Federal Register. This EO delays the effective date from January 22, 2021 to March 22, 2021 to allow additional time for review. The Final Rule applied to Federally Qualified Health Centers (FQHC) and required them to make 340B-purchased insulin and injectable epinephrine available at or below the 340B purchase price (plus a minimal administration fee) to qualifying, low income patients. This proposed delay of effective date and request for comments further delays the effective date from March 22, 2021 to July 20, 2021. This proposed delay was published in the Federal Register on March 11, 2021. The Most Favored Nation Model Interim Final Rule was scheduled to be implemented on January 1, 2021, however numerous court cases have delayed its implementation. Comments are due to CMS by 5PM EST on January 26, 2021, although that deadline may be extended based upon the White House Memorandum. We expect a delayed implementation date, rule revision, or rule revocation with further notice in the Federal Register prior to March 22. The MFN Model focuses on 50 Medicare Part B drugs that encompass a high percentage of Medicare Part B drug spending. CMS proposed paying providers such as hospitals, ambulatory surgery centers and physician offices the lowest price that drug manufacturers receive in other similar countries. In addition, providers would receive a flat add-on payment for each dose of the drug. Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” was published in the Federal Register on Jan 23, 2021 with an original effective date of March 15, 2021. Although this rule pertains primarily to a new pathway for coverage of innovative medical devices, the rule also includes a definition of “reasonable and necessary” which would be applied to all items and services that are furnished under Part A and Part B, including drugs. Update (3/17/21): This interim final rule was published in the Federal Register on March 17, 2021 and delays implementation until May 15, 2021. Comments can be submitted to CMS by April 16, 2021 as specified in the Notice. Update (5/18/21): This interim final rule was published in the Federal Register on May 18, 2021 and delays implementation until December 15, 2021. A review of comments received is included in this notification. Update (9/15/21): This proposed rule would repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule, which was published on January 14, 2021, and would be effective on December 15, 2021. Comments are due to CMS by October 15, 2021. Update (11/15/2021): This final rule repeals the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule, which was originally published on January 14, 2021. Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Managers Service Fees with an original effective date of January 29, 2021. (Update: 1/29/2021- Rule effective date has now been delayed to March 22, 2021.) (Additional update: 1/29/2021- Biden administration has agreed to delay the rule’s elimination of safe harbors for drug rebates by one year to January 1, 2023 (court order)) Clarifies and amends the discount safe harbor such that rebates paid from drug manufacturers to Medicare Part D prescription drug plan sponsors or their pharmacy benefit managers (PBMs) are not protected from liability under the discount safe harbor and adds a new safe harbor for point-of-sale reductions in price that are passed on directly to a buyer and an additional safe harbor for “legitimate” service fees paid to PBMs by drug manufacturers. Secure Electronic Prior Authorization for Medicare Part D with an original effective date of February 1, 2021. (Update: 1/29/2021- Rule has been delayed with new effective date of March 30, 2021.) Names a new transaction standard for Medicare Part D e-prescribing program to ensure secure electronic prior authorization request and response transmissions and requires support of version 2017071 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for use in certain electronic Prior Authorization (ePA) transactions with prescribers. Required use of the standard by January 1, 2022. In addition, two other drug-related rules have been recently implemented but had limited notice and comment periods. These rules may also come under additional scrutiny by the incoming Presidential Administration but are currently implemented: Department of Health and Human Services Good Guidance Practices with an implementation date of January 6, 2021. Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for Information Regarding Drugs Potentially Generally Recognized as Safe and Effectivewith an implementation date of December 25, 2021. Update (5/27/2021): Federal Register notice that original notice terminating the Food and Drug Administration’s Unapproved Drugs Initiative has been rescinded. https://public-inspection.federalregister.gov/2021-11257.pdf The Inpatient Prospective Payment System (IPPS), Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule Rules have statutory deadlines and were implemented on or before January 1, 2021 so we do not expect to have changes to the rules currently in effect. We will continue to follow these rules and implementation delays closely and provide updates when they are available. SHOUT-OUT! Watch for our newsletter or subscribe to our Apple Podcast-Pharmacy Revenue Cycle News for updates to these regulations as they become available!

18 // Come One, Come All for the Covid-19 Vaccine

01-18-2021

By now many of you have mobilized operations to begin the initial phases of vaccinating for Covid-19, but it doesn’t stop there. Operations are continually evolving invoking new challenges daily... (if not hourly). Billing for the Covid-19 vaccines has also presented some unique obstacles to overcome. The Coronavirus Aid, Relief and Economic Security (CARES) Act outlines several of these requirements. Billed Claim When the vaccines are provided free of charge, the vaccine product code should NOT be included on the claim. Only the administration codes should be reflected on the claims. Note, this is a different process than we typically see when we bill other drugs provided free of charge. CPT/HCPCS CMS has provided tables that call out each code, payment allowance and its effective date for the vaccines. There are a few reasons why these are unique and have created challenges around accurate charge capture and reconciliation. Each administration CPT is unique to the product administered The vaccine administration CPT are also unique to the dose administered Cost Sharing per Payer Medicare Part B: Covid-19 vaccine and its administration has been added to the preventive vaccines that are covered under Medicare Part B without deductible or coinsurance. Medicare Advantage Beneficiaries: Covid-19 vaccine and its administration for Medicare Advantage Beneficiaries will be covered through the original fee-for-service Medicare program for 2020 and 2021. Private Health Plans Non-grandfathered group or individual health plans must offer coverage to the Covid-19 vaccine and administration without cost sharing. No cost sharing also applies for both in-network and out-of-network plans. Medicaid, CHIP, and Basic Health Program: State Medicaid programs have seen a temporary increase in the Federal Medical Assistance Percentage (FMAP) to provide the Covid-19 vaccine and administration to its beneficiaries without cost sharing. There are some exceptions based on individual states’ statutes and offerings. Uninsured The Health Resources and Service Administration (HRSA) may cover the Covid-19 vaccine and administration. To receive HRSA funds, organizations must confirm the patient is uninsured. You must accept payment in full, and agree to not balance the bill patient. Also, you understand that payment is subject to post-reimbursement audit review. Shout Outs! Chargemaster and IT teams should ensure that only the vaccine administration codes are billed on the claim. The vaccine product code should not be billed out, even with a token charge while the vaccine is provided free of charge. Since the vaccine administration codes are unique to the product, these claims should not be held up in claims processor edits. Chargemaster and IT teams to validate the correct combination of vaccine manufacturers to administration codes are set up properly. It may be advantageous to have a validation process in place to monitor for miss-matches as patients begin receiving their second dose. Billing and Claims teams should ensure claims for Medicare Advantage Plans are set up to bill directly to original Medicare FFS. This may also require the claim to split from other services provided during that visit that should still be billed to the Medicare Advantage Plan. Billing and Claims teams to ensure out of network plans are set up to not balance bill the patient. Billing and Claims teams to also establish a process to validate patients are not eligible for any federal benefits and bill the HRSA program for any patients with limited benefits.

17 // MFN Model Rule under Temporary Restraining Order (TRO)

01-13-2021

(NUBC) has announced two new condition codes to be reported on CMS-1450 (UB-04)/837I (Institutional) claims effective February 1, 2021 that impact drug products. Condition Code 90– Expanded Access Approval (Service provided... as part of an Expanded Access Approval) Condition Code 91– Emergency Use Authorization (Service provided as part of an Emergency Use Authorization. Condition codes are added to institutional claims to identify events relating to billing that may affect processing. The current UB-04 (837I) claim has 11 fields for condition codes. They are 2-character alphanumeric fields and are reported in numerical order. The condition codes are reported “per claim” and are not associated with a specific line on the claim. Expanded Access The FDA indicates that “expanded access” is also known as “compassionate use” and is a pathway for patients to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. When a patient receives a “compassionate use” medication, Condition Code 90 should be added to the claim. Emergency Use Authorization The FDA maintains a list of products that have received the designation of Emergency Use Authorization which include in vitro diagnostic products, personal protective equipment and related medical devices, ventilators and other medical devices and drug and biological products. A specific list of drug and biological products is found here. As of 1/13/2021, the following drug products are listed as Emergency Use Authorizations and will require Condition Code 91 on the claim for dates of service on or after February 1, 2021: Moderna COVID-19 Vaccine 2. Pfizer-BioNTech COVID-19 Vaccine 3. Casirivimab and Imdevimab 4. Baricitinib (Olumiant) in Combination with remdesivir (Veklury) 5. Bamlanivimab 6. COVID-19 convalescent plasma 7. REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit 8. Fresenius Kabi Propoven 2% 9. Remdesivir for Certain Hospitalized COVID-19 Patients 10. Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions Other current EUAs are related to: Anthrax, Ebola Virus, Enterovirus D68 (EV-D68), Freeze Dried Plasma, H7N9 Influenzae, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Nerve Agent, and Zika Virus. Shout-Outs! Two new condition codes effective February 1, 2021 are reported on claims when products are used under “Expanded Access” (Compassionate Use), or “Emergency Use Authorization”. “Expanded Access” or “Compassionate Use” drugs may be administered for any investigational drug when approval is granted by the FDA.Pharmacyshould establish a process to notify Clinical Trial Coordinators, Revenue Integrity and Billers to ensure that these drugs are properly identified in the medical record and billers are notified to add the condition code to the claim. Clinical Trial Coordinators, Revenue Integrity and Billersshould be made aware of these new codes and processes established to ensure the drug with “Emergency Use Authorization” designation is properly identified in the medical record and that the codes are added to claims when these drug products are administered. FDA’s “Emergency Use Authorization”can be granted or retracted at any time. The FDA website should be reviewed frequently by Pharmacy and Pharmacy IT to determine the status of drug products. When changes occur, IT systems should be appropriately updated so that the medical record reflects the current drug status. Impacted personnel should also be notified of changes. **Please note that the listing of drug-related EUAs is current as of 1/13/2021. We recommend that you check the FDA link above frequently to determine drug status on or after 2/1/2021. The National Uniform Billing Committee (NUBC) was formed in 1975 to develop and maintain a single billing form and standard data set to be used nationwide by institutional, private and public providers and payers for handling health care claims and maintains the integrity of the UB-92 data set. The data set has become more than just a billing instrument as public health and health researchers use the data to gauge the delivery of health care services to patients.

16 // MFN Model Rule under Temporary Restraining Order (TRO)

01-04-2021

As we all ring in the New Year, let’s make the Pharmacy Revenue Cycle a priority for the New Year. This letter brings you a compilation of the top information... to set your Pharmacy Revenue Cycle information on the right foot with updates on the MFN Model Interim Final Rule, CY2021 OPPS Final Rule and updated tools for C9399 and Hemophilia Factor reporting. Most Favored Nation (MFN) Update On December 28, 2020, the US District Court for the Northern District of California issued a preliminary injunction that will prevent implementation of the MFN Payment Model Interim Final Rule at least until the completion of the notice and comment period on January 26, 2021. Notably, the M1145- MFN drug add-on, per dose has been published in CMS Addendum B effective January 1, 2021 with a payment status indicator of E1. CMS defines E1 as an item, code or services that are not covered by Medicare in Addendum D1. The I/OCE has not been published as of 1/4/2021; however, when posted in should be locatedhere. 2021 HOPPS Final Rule A few items to call out within the Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for 2021. The list is not designed to be all inclusive, but means to draw your attention to a few updates. Pass-through payment status expired for 29 drugs and biologicals at the end of December 2020 and another 25 that will end in CY2021. Payment methodology is unchanged from CY2020. The packaging per day cost threshold remains at $130 and the 340B payment discount continues at ASP- 22.5%. Pharmacy Revenue Cycle Tool Updates Drugs eligible for billing C9399 was updated as of January 1, 2021. Please reference our previous newsletter for more information regarding billing C9399. New FDA approved drugs added to the list include: setmelanotide, naxitamab-gqqk, rituximab-arrx, and ansuvimab-zykl. Drugs removed from the list as they have a unique HCPCS assignment include: daratumumab and hyaluronidase (J9144) and Mitomycin instillation (J9281). Payment Allowance Limits for Medicare Part B Drugs with Clotting Factor Designation. This list represents the CMS defined clotting factors and the payment allowance for both inpatient and outpatient hospital claims. Shout Outs! Pharmacy & Revenue Cycle Teams should have a dialogue on how to best proceed with managing the MFN claims. Due to the uncertainty of the rule implementation, a decision could be made to apply the M1145 to the claim now but strip the charge and code due to the E1 status indicator, or wait to apply the code and determine if rebilling is appropriate when the implementation status of the MFN Model Interim Final Rule becomes clear. Chargemaster and/or Informatics: Review the changes in HCPCS, status indicator and payment for the Hospital Outpatient Departments and ASC. Ensure the changes are reflected in the EMR for proper billing including the application of the TB vs. JG modifier for 340B eligible purchases. Chargemaster and/or Informatics: Review the list of drugs eligible for billing with a C9399 or listed as a hemophilia clotting factor. Changes may be required to ensure that you populate the final claims with the correct information.

15 // MFN Model Rule under Temporary Restraining Order (TRO)

12-28-2020

According to news reports from Reuters and Modern Healthcare (subscriber only content), a judge in Maryland has issued a temporary restraining order (TRO) for 14 days (which will expire January 6th) to prevent CMS... from implementing the Most Favored Nation (MFN) Model Rule on January 1, 2021. The restraining order was on the basis that CMS did not give adequate notice as required under the Administrative Procedures Act and that there is the potential for irreparable harm. The TRO can be extended again, a hearing can be held during the order, or the TRO can expire. A reader has asked, “What do we do now?” and our response, “We don’t know exactly what will happen!” The M1145 code is posted in the CMS quarterly updates as a valid code, but since the definition includes “MFN drug” and that is defined in the rule that is under the TRO, it is unclear if that is really a valid code on 1/1/2021. In addition, CMS has not released either the Addendum B or the OCE update (as of this morning 12/28/2020) which will have the payment rates for 1/1/2021 that are embedded in the software that the MACs use to process claims. So it is possible that even through there is the TRO, the “payments” may be the MFN rates until this is resolved. Claims could potentially be reprocessed by CMS whichever direction it goes in. So—as far as advice to our readers—that all depends. Typically facilities will hold outpatient claims each quarter until the Outpatient Grouper is loaded which usually takes 10-14 days. Then the facility will “regroup” the claims to pick up the new/revised codes. So we do probably have about 2 weeks for this to shake out before it impacts our actual claims processing. With that, you could: If the programming is in place to automate M1145, you could implement on 1/1/2021 and hold claims until the outpatient grouper is loaded. At that point you can make a decision to process them as is, or to put in an edit to “strip” the M1145 code before transmitting the claim if the rule is delayed. You could not implement the M1145 and wait to see what happens. You will report the same HCPCS code for the drug no matter if the rule is further delayed or not, so you are really talking about the drug add-on payment (M1145) as being in dispute. Then if by the time you get ready to transmit your claims, you can decide whether to go back and add the M1145 to your existing claims, if needed. So—you are right. It is anyone’s guess. We don’t have a crystal ball. We would suspect that CMS will continue to argue that it is necessary for price controls, however, they may delay implementation for a quarter or two to give everyone an opportunity to provide comments by the deadline of January 26 and for CMS to respond to them. We have a number of questions open with CMS right now, but have not heard back from them on any of them yet but are following these developments closely and will let everyone know as the court case progresses. Happy New Year! Maxie and Agatha

14 // A Christmas Present-Will the MFN rates increase or decrease your drug revenue?

12-21-2020

CMS has posted the Most Favored Nation (MFN) Model final payment rates on the Innovation Center website here: January 2021 MFN Model Drug Pricing File (XLS). The drugs will be reimbursed... based upon 75% of the applicable ASP and 25% of the MFN price for which MFN pricing was available. Otherwise the payments rates are 100% of ASP. Column D contains the MFN Drug Payment Amount Limit. This payment will continue to be subject to Medicare co-pays and deductibles, however the payment rate for M1145 will not as Medicare will reimburse the full amount to providers with no co-pays or deductible requirements from beneficiaries. The Innovations Center also contains a slide deck of addition information on the Rule: MFN Model: Billing Information Slides (PDF) We noted that CMS has clarified a statement in the rule and indicated that Hospital Outpatient Departments paid under OPPS may report a token charge for M1145, but will continue to be reimbursed $148.73. The claims processing systems will reimburse the lesser amount of the allowed amount or billed amount to other providers such as physician offices. Modeling of the new Rule is complex as the ASP Pricing File for January 2021 continues to reflect ASP+6% rates. For the 50 impacted drugs, these rates will need to be adjusted to arrive at the ASP price. In addition excepted and non-excepted departments are reimbursed at different rates for 340B-purchased drugs. It is important to distinguish the type of departmental registration in order to calculate any reimbursement shifts based upon the rule. We appreciate CMS’ posting of the new files, but we still have questions that we are submitting to the CMS MFN mailbox and will be including in our Rule Comment Letter due January 26, 2021. Will you help us by reviewing these questions and then submitting any additional questions to us so that we can forward them to CMS for a response? Drug Payment Issues For pass-through drugs in hospital outpatient departments (status indicator=G) (J0517- Inj., benralizumab, 1 mg, J9311-Inj rituximab, hyaluronidase, Q5111-Injection, udenyca 0.5 mg): Will providers receive ASP+6% until the drugs’ pass-through status expires, or will they be subject to the MFN blended payment as of January 1, 2021? (The CY2021 OPPS Final Rule (Display Copy-page 539-540) indicates that drugs with pass-through status purchased under 340B will continue to be billed with the “TB” modifier and paid at ASP+6% as currently). Excepted 340B hospitals report a TB modifier for drugs represented by a K or G status indicator. In the CY2021 OPPS Final Rule, states hospitals shall continue to receive ASP+6%. Will providers who report the TB modifier receive the current rate or the MFN blended payment model? Will the 2% hospital sequestration scheduled to be enforced again on January 1, 2021 reduce the MFN Drug payment rates by 2% of will they not be impacted by sequestration? If these Part B drugs are administered under Home Health benefits or in a “Hospital without walls” scenario in the patient’s home, are the payment rates the MFN blended payment rates? Calculation and billing of M1145 dose “units” In a situation where two National Drug Codes (NDCs) are used to make one dose (e.g. Rituximab 500 mg and 100 mg vials), the two lines are reported separately when NDCs are reported. For M1145 reporting, will this count as “1” or “2” doses since there are two lines? In a situation where a dose is split between two lines because of an MUE with a line edit, does that count as “1” dose or “multiple doses” depending upon the number of lines? Reference Novitas Local Coverage Article: Billing and Coding: Hemophilia FACTOR Products (A56433) which instructs to bill on multiple lines with modifier -76. If we are reporting a HCPCS code for a “NO COST” item based upon CMS Transmittal 4013- Institutional Billing of No Cost Items, should we also report M1145 with a dose of “1” if the no cost item is a HCPCS for an MFN drug? In a scenario where a patient receives the same drug twice in one day, we assume that we should report M1145 with units of “2” for two separate doses. Is there a modifier that we should use to indicate that it is correct and not a billing error? We see the notation about hospital outpatient departments ability to submit a token charge but still be paid at the $148.73 rate. Is this true for ambulatory surgery centers also, or will they be reimbursed like physician offices: the lower of the billed or allowed amount? We assume that for recurring accounts that are only billed once every 30 days, CMS claims processing will recognize multiple claim lines with M1145 for each day that an MFN drug is billed. Is that correct? Since M1145 is an add-on payment for the drug, we assume that it should be reported in revenue code 636. However, there is no NDC number associated with M1145. For dual eligible patients (Medicare primary/Medicaid secondary), will Medicaid programs be instructed to NOT require an NDC number on M1145 when receiving claims electronically from the Medicare system and carve M1145 out of the editing processes for “NDC required for Line Item”? Drug Shortage Leuprolide Acetate (J9217) appeared on the FDA Drug Shortage listing as of December 11. Will the posted payment rates for January 1 be updated to reflect that J9217 will be reimbursed at ASP+M1145 add-on payment instead of the MFN rate (a difference of $26.318 per 7.5 mg)? Policy The Outpatient Prospective Payment System is a budget neutral payment methodology. Will the savings from the lower payments for MFN drugs be redistributed to other Part B non-drug services similar to the redistribution with the savings from the lower 340B payment rates? IF YOU HAVE A QUESTION NOT LISTED ABOVE, PLEASE SUBMIT TO OUR WEBSITE AT: https://www.pharmacyrevenuecycle.com/contact-us. We’ll respond with an answer, or submit it to CMS and then forward you their response when we receive it. Happy Holidays! Agatha & Maxie

13 // Questions on the Most Favored Nation (MFN) Model Rule

12-14-2020

We’ve had another great question this week about the “Most Favored Nation” Model Rule and billing the new HCPCS code, M1145- MFN drug, add-on payment. Question: How would you... suggest establishing the M1145 charge in the charge router in order to ensure billing compliance across all financial classes? Answer: We agree that there are a number of factors that contribute to this decision and it is a gray area in the Interim Final Rule. Without additional guidance from CMS or other payers, we recommend billing M1145 on all patients regardless of payer or patient type. Below we’ve outlined some pertinent Medicare instructions on establishing charges, balancing of primary and secondary payer claims, as well as previous situations where Medicare created special HCPCS codes that result in “add-on” payments for drugs that you should consider in setting up your Chargemaster with this new HCPCS code. Provider Reimbursement Manual Instructions First, let’s talk about the charge instructions. The Medicare Provider Reimbursement Manual- Part 1, Chapter 22 includes section 2202.4 which is the definition for “Charges”: “Charges refer to the regular rates established by the provider for services rendered to both beneficiaries and to other paying patients. Charges should be related consistently to the cost of the services and uniformly applied to all patients whether inpatient or outpatient. Based upon this definition, we interpret that your charges need to relate to your overall costs (which include handling, storage and overhead), and are applied to both Medicare patients and other paying patients. The charges also need to be the same whether the patient is an inpatient or outpatient status. Medicare indicates that these charges are reported at “gross value”; i.e., charges before the application of allowances and discounts deductions. Based upon these instructions we believe it would be appropriate to bill M1145 to all payers and patient types. These are billing instructions only, not necessarily payment. Although Medicare will pay at a rate of $148.73 in the 1stQU2021 per billed unit, other payers may choose to not recognize M1145 or to not pay any additional separate payment based upon contracted terms or subsequent policies. We hope that other payers will not choose to reject claims entirely since it is a valid HCPCS code, effective January 1, 2021. If a payer continues to reject a claim stating the M1145 is not recognized, an alternative recommendation may be to remove the HCPCS and bill the charge under revenue code 250 to ensure the total charges on the claim balance regardless of payer. Matching of Primary and Secondary Payer Claims: Total charges Second, it is important that any charges billed to a primary payer also be represented on the claim for a secondary payer as the charges need to match in order to determine what portion the primary payer has paid and what amount the secondary payer is responsible for. In the case of dual eligible patients with Medicare primary and Medicaid secondary, CMS electronically submits the claim after adjudication to the appropriate Medicaid program so the M1145 will be transmitting automatically. It is unclear if State Medicaid programs will recognize this as an “add-on” payment and NOT require an NDC number on the charge line even if the charge is reported in revenue code 636 or 250. Under Medicare Secondary Payer rules, the amount the provider bills for services rendered (Charge Amount) should match the amount billed to both the primary insurer and Medicare. For other secondary payers, removing the M1145 charge from either payer claim will cause balancing issues when reconciling insurer payments and patient responsibility. If a secondary payer rejects a claim with the new M1145 code, it is recommended that the payer be contacted for clarification as it is a valid HCPCS code. We do not recommend that billers automatically mark the charges as non-covered for both Medicare and non-Medicare as this will result in a loss of revenue from non-billing of a valid service. Another consideration is that insurance information often gets changed from the original information provided at registration. If a facility is selectively reporting the M1145 code based upon the insurance plan, resequencing of payer information can lead to claim processing delays. Other situations when Medicare has established a drug add-on payment In 2006, CMS recognized that Intravenous Immune Globulin (IVIG) products were in short supply and significant resources were expended in locating IVIG products in both hospitals and physician offices. HCPCS code G0332 – Preadministration-Related Services for Intravenous Infusion of Immunoglobulin, (this service is to be billed in conjunction with administration of immunoglobulin) was used to bill for the service of locating and shipping of IVIG. This HCPCS code had to be billed on the same claim as the IVIG product and the same date of service. Medicare established an add-on payment of $75 in the hospital outpatient setting and expected the G0332 to be billed only once per date of service. This payment was in addition to the payment for the drug and the drug administration service. Medicare established edits so if G0332 was billed without the drug product HCPCS code and a drug administration service, the claim was returned to the provider to be reviewed and revised. An edit also rejected a claim if G0332 was billed with a unit of more than “1” for each date of service. This payment was continued through CY2008 and eliminated as of January 1, 2009. (Note: Medicare has not indicated yetwhether they will establish similar edits for the MFN Model drugs with HCPCS code M1145). In 2013, Medicare established HCPCS code Q9969- Tc-99m from non-highly enriched uranium source, full cost recovery add-on, per study dose (FR page 68316) to be billed separately from the TC-99m radiopharmaceuticals that are used in diagnostic procedures. Medicare provided instructions that the code would be paid at $10.00 per dose. HCPCS code Q9969 continues as an active code with a payment rate of $10.00 per dose in the October2020 Addendum B. (Note: Medicare has reminded providers that for the MFN Model, they will pay the lower of the established payment rate of $148.73 or the claim charge, so in order to receive the $148.73 per dose, providers should ensure that M1145 has an established charge of $148.73 or greater). In summary: We recommend that M1145 be set up to bill all payers on both inpatients and outpatients based upon: Medicare instructions that charges for services should be the same for all payers and patient types and based upon costs (including handling, storage, and overhead), the requirement that primary and secondary payer claims balance regarding individual and total charges to ensure appropriate reconciliation of payer and patient financial responsibility, and, previous precedents where Medicare has established specific drug add-on codes with payment rates. We also recommend that initial claims be closely scrutinized to verify that the units of M1145 are being billed correctly (‘per dose’), that Medicare is applying the appropriate payment rate, that other payers are not rejecting claims which contain M1145, (effective January 1, 2021) and are reimbursing according to contracted terms and policies.

12 // Questions on the Most Favored Nation (MFN) Model Rule

12-08-2020

Thank you for continuing to read our newsletters and submit comments and questions! We have heard several questions related to our previous newsletter regarding the recently issued rule by CMS... impacting Part B medication payments, Most Favored Nation (MFN). Today’s edition is geared toward answering your questions! Please reference last week’s newsletter for an overview of the MFN rule: Black Friday Price Drop!!!-For Drug Payments?? What is the add on payment for the new MFN drugs? CMS has published the HCPCS M1145 – MFN drug add-on, per dose. This code is to be billed with each dose of an MFN drug and will be reimbursed $148.73 in Q1,2021. M1145 will replace the 6% of ASP add on payment that most providers receive today for the same drug. How do I bill the per add on dose? M1145 represents “per dose”. A dose is defined as a line item for that HCPCS code by Date of Service and does not include lines that report waste with a JW modifier. This HCPCS code must be added as a single line item per claim, and all “doses” of MFN-designated drugs totaled so that the billed units of M1145 is equal to the total doses of all MFN-designated drugs billed on the claim To illustrate this: The organization on a monthly billing cycle infuses 2 doses of rituximab (J9312) 450 mg with 50 mg of waste with each dose. No other services are provided. Note the billing for the drug and administration services do not change and should reflect the practice your organization is doing today. The M1145 is a new line item that should be added to the claim per date of service. This example displays M1145 with 2 lines which represent the 2 doses received on 11/05/2020 & 11/19/2020 respectively. To further illustrate, we applied a markup on top of the payment amount of $148.73. We recommend your markup reflect your standard of practice within your organization, but covers the handling, storage and other overhead cost of the drug. For 340B institutions, what is the payment rate when a JG vs. TB modifier is applied? Select 340B providers have been required to apply a TB or JG modifier to 340B purchased drugs. Today and continuing for CY2021, a TB modifier is informational only and a JG modifier signals a payment reduction by CMS to ASP – 22.5%. When a MFN drug is used and purchased at the 340B price in which a JG modifier is applied CMS will be pay the lower of: ASP – 22.5% (see the OPPS Final Rule), or ASP+MFN blended payment In either scenario, CMS will also apply the add-on payment (M1145) to all 340B eligible drugs. It is unclear in the MFN rule how the drugs in which the TB modifier is applied will be paid. A TB modifier may be applied to a 340B purchased drug with “pass-through” status or applied to a 340B purchased drug at an excepted location. CMS has language within the OPPS that grants a manufacturer 2-3 years of pass-through status for eligible drugs and continues to receive a payment rate of ASP+6%. The language is conflicting and further guidance is needed from CMS. Do I do anything different as a provider when a drug is listed on the FDA drug shortage list? Drugs listed on the FDA listing of drug shortages will revert back to ASP+6% reimbursement on the first day of the next quarter in which they appear on the drug shortage list. Providers should continue to bill the add on code (M1145) when using the MFN drug even while it is listed on the FDA drug shortage list. CMS will determine how to temporarily pay providers at the ASP+6% versus the ASP + MFN blended payment. How often will the list of drugs be updated? According to the rule, the list of drugs will be updated annually, effective each January 1. In general, these Top 50 drugs will remain on the list, but new drugs may be added each year. Other information will change on a quarterly basis. For example, the ASP and Most-Favored Nation Model payment rates will be recalculated each quarter. In addition, a drug that appears on the FDA drug shortage list will have the payment revert back to ASP on the first day of the next quarter and will remain until it is removed from the drug shortage list when it will move back to the MFN Model payment on the first day of the next quarter. The expectation is that manufacturers will lower their price for these products when they are used on Medicare beneficiaries so that providers will not be reimbursed less than the payment they receive. Are you aware of any manufacturers that have announced price decreases? We have not seen any manufacturers publicly stating that they will be offering price reductions based upon this Rule, but it is early since the Rule was just published in the Federal Register on November 27, 2020. However, if manufacturers do provide different pricing, they have to exclude those sales units when they report the average sales price (ASP) the next quarter to CMS so that it doesn’t dilute out the ASP pricing calculation. This may be problematic as manufacturers may require providers to accumulate those purchases separately. One option is to set up a separate account similar to 340B accounts. The rule does not specify a specific process to track products paid under the Most Favored Nation Model, so it will be up to each manufacturer to determine how best to verify the information. When will we know the final payment rates effective January 2, 2021? We don’t know. According to the rule, it appears that there will be a separate table posted on a unique CMS website devoted to the Most Favored Nation Model. That website is: https://innovation.cms.gov/innovation-models/most-favored-nation-model. We recommend checking the website often. Please continue to submit your questions and have your question answered!

11 // Black Friday Price Drop!!!- for Drug Payments??

11-30-2020

Does 2020 have more surprises for us? Well, CMS released an Interim Final Rule published in the November 27, 2020 issue of the Federal Register that will potentially decrease payment... for fifty expensive drugs provided in hospital outpatient departments and physician offices starting January 1, 2021 (“Most Favored Nation (MFN) Model”). Although a similar advance notice of proposed rulemaking (ANPRM) (83 FR 54546) was issued in October 2018, this Final Rule has significant logistical differences from the original proposal, including specific instructions on claims billing. What We Know Who is impacted? All beneficiaries enrolled in Medicare Part B who have Medicare as a primary payer and are not covered under Medicare Advantage or another group health plan are included and receive an MFN Model Drug from an MFN provider. Providers are generally those who submit a claim for a separately payable drug under Part B that is an MFN Model drug, e.g. physician offices, outpatient hospital departments (including on- or off- campus provider-based departments) and Ambulatory Surgery Centers. This rule does not apply to Critical Access Hospitals, certain Children’s Hospitals, Rural Health Clinics, Federally Qualified Health Centers, and certain Cancer Hospitals. Hospitals who receive payment on a fully capitated or global budget basis will be excluded for first and second quarter of performance year 1. What drugs are impacted? Medicare has identified the Top 50 single-source Part B drugs with the highest annual 2019 spend by HCPCS code (with a few exceptions) that will be subject to “Most Favored Nation” (MFN)” Model pricing starting January 1, 2021. A list of the 50 HCPCS impacted for January 1, 2021 is here: Table 2: Performance Year 1 MFN Model Drug HCPCS Codes List with Top Billing Specialties. How will the drugs be paid? The model will be phased in over 7 years, with Year 1 paying for these drugs with a 75% ASP reimbursement and 25% MFN pricing. The MFN pricing is the lowest per capita Gross Domestic Product-adjusted (GDP-adjusted) price of any non-U.S. member country of the Organisation for Economic Co-operation and Development (OECD) with a GDP per capita that is at least sixty percent of the U.S. GDP per capita, based on available data. If the applicable ASP is less than the MFN Price, the MFN Price will be established as equal to the ASP. (Note: this is the ASP (average sales price), not the ASP+6% amount as published in the current ASP pricing files, and Addendum B). 340B purchased drugs will be paid the lower of: 1) proposed reimbursement in Hospital Outpatient Prospective Payment System (OPPS) Final Rule (which has not been released as of today, 11/30), or 2) the (ASP+MFN blended payment) + add-on payment. 340B purchased drugs will be eligible for the add-on payment regardless of which payment methodology is used. What about the add-on payment? Medicare will pay an “add-on payment” in the amount of$148.73per “dose”. A dose is defined as a line item for that HCPCS code by Date of Service and does not include lines that report waste with a JW modifier. A new HCPCS code has been assigned: “M1145-MFN drug add-on, per dose” to compensate for the overhead and handling of the products. MFN participants will need to ensure that they submit an appropriate charge for the add-on payment since Medicare allows the lesser of the applicable payment amount or the billed amount. (Providers who bill less than the $148.73 per dose, will receive the lower amount as payment). The MFN add-on payment will be adjusted each quarter for inflation. This HCPCS code, M1145must be added as a single line item per claim, and all “doses” of MFN-designated drugs totaled so that the billed units of M1145 is equal to the total doses of all MFN-designated drugs billed on the claim. There will be no co-pays or deductibles for the beneficiary for the add-on payment, but co-pays and deductibles will continue to apply for the base drug payment. What about drugs on the FDA drug shortage list? Drugs listed on the FDA listing of drug shortages will revert back to ASP+6% reimbursement on the first day of the next quarter in which they appear on the drug shortage list. (This initial list does not contain IVIG products since two products are currently on the drug shortage list). However, in the future, products in drug shortage will not be removed from the list, but will temporarily be reimbursed at the ASP rate (+ the add-on payment) until the shortage is resolved. These changes will occur on a quarterly basis. How will the drug list and payment rates be updated each quarter? CMS will add drugs to the list annually, but does not anticipate removing drugs, except only rarely. Under very limited circumstances, drugs may be removed from the list on a quarterly basis. According to the rule, MFN Model payment amounts and other information and materials will be posted at https://innovation.cms.gov/innovation-models/most-favored-nation-model in advance of each calendar quarter. How will CMS monitor the impact of the Model? CMS will be monitoring claims to determine if utilization has shifted to newer, more expensive drugs, or if beneficiary access to services changes adversely. CMS will be conducting beneficiary surveys to determine beneficiary satisfaction with the new model. What information will manufacturers need from providers to adjust their ASP submissions? Manufacturers must exclude MFN Model drug units furnished to MFN beneficiaries for which payment is allowed from their calculation of ASP (Average Sales Price). In order to determine the number of units to exclude, CMS anticipates that manufacturers may establish mechanisms to obtain such information, for example, manufacturers could require separate purchasing accounts, or reporting of information about units of MFN Model drugs furnished to MFN beneficiaries and for which payment was allowed. SHOUT-OUTS Pharmacyand Finance should review the list of 50 Most Favored Nation Model Drugs to determine utilization and calculate reimbursement changes when payment rates are posted in late December (presumably with new MFN Model tables on CMS website). Illustrative payment changes are available in Table 6 of the rule. Pharmacyshould work with their Group Purchasing Organization (GPO) to determine if there are any anticipated decreases in contracted costs commensurate with decreased reimbursement for MFN Model drugs for Medicare beneficiaries effective January 1, 2021. Pharmacyand Health-System Administration should dialogue with Medical Staff members to determine if some infusions may transition to hospital outpatient departments due to reimbursement shifts (Table 8 describes anticipated changes in revenue per Medical Staff Specialty). Finance, Revenue Cycle and ITshould explore automating the process of adding the add-on payment HCPCS code M1145 to the claim with the correct number of billed units calculated using the total “doses” of MFN-designated drugs represented on the claim. If automation is not feasible,Revenue Cycleshould stop every claim with an MFN-designated drug to have the M1145 billed units calculated and added manually to the claim. Billersshould be educated that if a payer rejection results in an MFN-designated dose to be marked non-covered (e.g. for medical necessity), the biller must review the billed units for M1145 and adjust the billed units accordingly by removing the number of “doses” that were marked as non-covered. If only the billed units of the drug are adjusted (e.g. an MUE lowers the billed units), the billed units of the add-on payment does not need to be adjusted as the payment is “per dose” regardless of the size of the dose. Finance, Revenue Cycle and ITshould explore how they will capture the billed units per HCPCS code and per manufacturer in order to provide the information to the manufacturer for ASP reporting. ITwho loads CMS tables for modeling or expected payment should be aware that Addendum B payment rates will be overridden by MFN Model payment rates + add-on payments and MFN payment rates will be available on a separate CMS table. Managed Care Contractingshould review any third-party payer contracts with statements that pay for outpatient drugs “like Medicare” or that use Medicare payment rates as a basis for their contract. What we don’t know? We don’t know when the actual rates will be posted for January 1, 2021 as the sources files of pricing from other countries has not yet been determined. According to the rule, MFN Model payment amounts and other information and materials will be posted athttps://innovation.cms.gov/innovation-models/most-favored-nation-modelin advance of each calendar quarter. We presume that if a “dose” is split into two lines to report two different National Drug Code numbers (NDC) on a dual eligible patient for Medicaid, that the units of M1145 will be “1” for the dose, even though the dose will be reported on two separate lines with two different NDC numbers. An example would be for Rituximab (J9310) where both 100 mg and 500 mg vials are used to admix a single dose and each NDC is reported separately. We don’t know if manufacturers will provide alternative costs for MFN Model drugs, and if the manufacturers will require providers to submit usage data to the manufacturers to adjust ASP reporting. Although unlikely for this group of drugs, we presume that if a patient receives two doses in one outpatient visit for one date of service, that will be counted as “two doses”. However, there are no modifiers or any additional qualifiers that can be added to the claim to explain this anomaly. We don’t know what notification process will be in place to notify providers that a drug has been placed on the FDA drug shortage list and therefore will revert back to ASP + add-on payment reimbursement. Since the Outpatient Prospective Payment System (OPPS) is budget-neutral, it is unclear if the “savings” from the MFN Model for hospital outpatient departments will be redistributed as increased payments for other services. (as of 11/30/2020, the CY2021 OPPS Final Rule has not been posted). It is unclear for recurring accounts with multiple dates of service, if multiple lines with HCPCS code M1145 will be permitted, calculated per date of service. Comments are due to CMS by 5PM (Eastern) on January 26, 2021 with electronic submission instructions included in the Interim Final Rule. Please check our website frequently for updates!

10 // Covid-19 Monoclonal Antibody – Can you say Bamlanivimab 10 times fast?

11-16-2020

Likely, you just heard of Bamlanivimab, and like wildfire it is being repeated in meeting after meeting within your organization. On November 9th, the FDA issued an emergency use authorization (EUA) for the... investigational monoclonal antibody therapy, bamlanivimab for the treatment of mild-to-moderate COVID-19 patients. The monoclonal antibody is expected to be distributed within the next week. Unlike the investigational therapies before it, this infusion will target your outpatient sites of care and add a layer of complexity with billing in which we have outlined. Bamlanivimab EUA is extended to patients with a positive SARS-CoV-2 test, >12 years, weighs at least 40kg, and who are at high risk of progressing to severe COVID-19 and/or hospitalization. The authorization does not extend to patients hospitalized, requiring oxygen therapy due to COVID-19, or individuals with increased oxygen requirements due to COVID-19. Additionally, bamlanivimab may only be administered in a location in which the healthcare provider has immediate access to treat a severe infusion reaction. In the CMS bulletin, two codes have been published to represent the drug and the administration of the drug. 1) Q0239, injection, bamlanivimab-xxxx 700 mg to be used to represent the drug 2) M0239, intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring The administration code is inclusive of the one hour infusion and post infusion monitoring in a hospital outpatient setting. CMS has established a payment rate for the administration of the intravenous infusion, M0239, of $309.60 (not inclusive of the geographical adjustments). This payment rate is aligned with a level 4 drug administration. When bamlanivimab is provided free of charge, CMS has directed providers to ONLY bill for the administration and the Q0239 should NOT be included on the claim. This is different from other drugs provided free of charge in which the HCPCS representing the drug code should be listed on the claim with a token charge to allow the claim to bypass claim edits. Services for beneficiaries covered under Medicare Advantage Plans should have claims billed directly to the Original Medicare (Medicare Fee For Service) for bamlanivimab administration through 2020 and 2021. SHOUT-OUTS! CDM and Billing Teams. When provided free of charge, validate the Q0239 for the drug is not listed on the claim. This is a different practice from other drugs provided free of charge. Consider holding claims until the MAC, claim processors and alike have the time to update their software to accept the new codes. Pharmacy Teams. Ensure documentation in the patients’ medical record includes a positive COVID-19 test documented and they meet the criteria outlined in the EUA. Billing Teams. Validate claims are being sent to Original Medicare for all Medicare Advantage Plans and monitor a few claims to ensure they are processed correctly. Additionally, validate the billing code or charge is set up to not drop to patient responsibility for the copay or deductible. PLEASE NOTE: This information is current as of the publication date of this newsletter (11/16/2020). The FDA and CMS may publish additional instructions which may supersede the information in this article.

09 // Don’t Let Rabies Take a Bite Out of Your Revenue

11-09-2020

Seems like a slam dunk, doesn’t it? A patient comes to the Emergency Department with an animal bite. A standard CDC protocol for rabies post-exposure prophylaxis (PEP) outlines initial therapy with both... rabies immune globulin and rabies vaccine, with additional vaccine on Days 3, 7, and 14. An 5th dose of vaccine may be needed on Day 28 if the patient is immunocompromised.What can possibly go wrong with the reimbursement? Well apparently a lot, since we see many write-offs, mostly for visits when the patient returns to the Emergency Department for their subsequent vaccine doses. The CDC tell us that 55,000 Americans receive post-exposure prophylaxis for rabies each year, so that’s approximately 220,000 ED visits per year, and it is predominantly in areas where there are wildlife such as bats, raccoons, skunks, and foxes. Just for the immune globulin alone, the estimate is over $165 million in reimbursement. Almost all State Health Departments have stopped providing rabies immune globulin and rabies vaccine at no charge, so these patients all end up in hospital emergency departments. What do I need to do to prepare claims for rabies treatment? There are two CPT codes for rabies immune globulin, 90375, and 90376 if the product is heat-treated. Typically, the heat-treated product is reimbursed at a higher rate (about $58 more per 150 I.U. from Medicare effective October 1, 2020) so it’s important to get the code right based upon the product used. There are two different codes for rabies vaccine, 90675 for intramuscular and 90676 for intradermal. These also have a payment differential. Rabies immune globulin is available in two strengths depending upon the product: 150 international units (I.U.)/ml and 300 I.U/ml. CMS indicates on the ASP NDC-HCPCS crosswalk that CPT codes 90375 and 90376 should be billed per 150 I.U. so the billing set-up is important.It’s also important that you don’t inadvertently bill “per vial” since the products come in multiple product sizes and per vial charges always result in lost revenue. If a portion of the immune globulin product is used for infiltration, the amount should be clearly documented in the medical record in addition to the amount administered intramuscularly so the total amount can be billed. If any amount is discarded, it should be documented in the medical record and billed as drug waste (with a JW modifier if required by the payer). Emergency department caregivers should be reminded to clearly document return visits aspost-exposure prophylaxis as well as the suspected animal. The coders can then be specific in coding as payers may distinguish coverage based upon whether the vaccine is administered: for prophylaxis (Z23 (encounter for immunization)) or, post-exposure prophylaxis (Z20.3 (contact with and (suspected) exposure to rabies)). Payers often do not pay for routine immunizations, but do pay for post-exposure prophylaxis. The specific “Z” code on the claim distinguishes the two. Documenting “contact with suspected exposure to rabies” should be done for EACH ED visit. ICD-10-CM codes are unique and distinguish between bites by mice, rats, squirrels, other rodents, dog, cat, horse, cow, other hoof stock, pig, raccoon, and other mammals. During times of drug shortage, the WHO recommends intradermal administration as a means to preserve vaccine supplies which uses fewer vials. Since this is an off-label dose and route, we recommend documenting in the patient’s medical record that rabies vaccine was in short supply which necessitated the intradermal administration protocol. SHOUT-OUTS! The Pharmacy Department should ensure that the correct HCPCS codes are billing for the administered product and that heat-treated rabies immune globulin is distinguished from non-heat-treated for billing purposes and that the billed units are per 150 I.U. The Pharmacy Department should meet with the ED Physicians to ensure that documentation of “contact with suspected exposure to rabies from <type of animal>” is associated with the initial visit as well as subsequent visits so that the claim isn’t inadvertently billed as a preventive immunization. Patients who are immunocompromised should have their immune status clearly documented in the medical record if they return for a 5th dose of vaccine on Day 28. Coders should query physicians if incomplete documentation is in the record, (e.g. “Patient has returned for second dose of rabies vaccine) to ensure that the correct diagnosis code indicating exposure is included in the claim. Pharmacy and Revenue Integrity should explore patient assistance programs that cover some rabies vaccine and rabies immune globulin when appropriate.

08 // Remdesivir added to C9399 Tool

11-02-2020

In this Special Bulletin of Pharmacy Revenue Cycle News, we are answering questions sent to us from Michael from a health-system in Indiana. Michael writes, “When do you use HCPCS code C9399 versus...

07 // Medically Unlikely Edits (MUE)

10-26-2020

Medically unlikely edits or MUE are designed to help reduce the number of billing errors, but have the potential to create obstacles within the pharmacy revenue cycle. The National Correct Coding... Initiative (NCCI) Policy Manual for Medicare Services was developed to encourage consistent and correct coding thereby reducing inappropriate payments. The NCCI Policy Manual for Medicare Services contains 13 narrative chapters in which chapter XII which addresses HCPCS Level II codes and MUE. Each quarter the NCCI is updated to reflect changes from 3 sources 1) additions, deletions, or modifications in the CPT manual or HCPCS 2) CMS policy initiatives and 3) comments from the American Medical Association and other national or locally recognized healthcare organizations. It is important to note that all NCCI edits will auto-deny a claim but may be appealed. A MUE value represents the maximum number of units of service or billed units for a given HCPCS or CPT that are allowable for the same provider, same beneficiary on the same date of service. Each HCPCS or CPT is associated with a MUE Adjudication Indicator or MAI along with the MUE value. An MAI of “1” indicates that the edit is a claim line edit and a modifier may be necessary when billed in excess of an MUE. An MAI of “2” is a per date of service based on policy and has undergone a rigorous review. It would be impossible to justify a claim that has been billed in excess of the MUE limit as it would be contrary to statute, law or other subregulatory guidance. An MAI of “3” are per day edits based on clinical benchmarks. It would be possible but medically unlikely that a service would exceed an MUE value. If the provider can provide evidence to the Medicare contractor for the services billed in excess these auto-denials may be overturned. The majority of drugs and biologics are represented with a MAI of “3”. CMS uses several factors when determining the MUE value for drugs and biologicals. Some of these factors include maximum daily dose based on prescribing data, maximum daily dose calculated based on body weight and other published material related to the drug or biological. These attributes are evaluated in combination with claims data to develop the final value for the MUE. The MUE values for a HCPCS or CPT are located on the CMS website under the NCCI subsection (here). The file contains the HCPCS and CPT, representing MUE value, MAI and the MUE rationale. For example, J9041 (bortezomid (Velcade) 0.1 mg) has a MUE value of 35 and an MAI of 3. This means when any dose above 3.5 mg is billed on the same date of service to a beneficiary, the claim will auto-deny. Bortezomid dose is based on body surface area in which some patients may exceed a dose of 3.5 mg. In this case, the claim must be appealed. Shoutouts! Collaborate! Understanding and appropriately appealing MUE denials lends itself to collaboration among pharmacy, billing and denial teams. Monitor denials that are due to excess MUE. Validate the claims were billed appropriately based on the service provided. Appeal the denial if there is evidence to support its use.

06 // What’s New? Using HCPCS Code C9399

10-19-2020

HCPCS code C9399-Unclassified drugs or biologicals, can be used to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the FDA on or after January 1, 2004... when a product-specific HCPCS code has not yet been assigned when furnished in hospital outpatient departments. (Medicare Claims Processing Manual, pg 63). This C9399 tool includes the generic and brand names, approval dates, manufacturer, and a link to the prescribing information (PI) for injectable drugs that have been approved by the FDA but have not been assigned a HCPCS code by CMS. This list will be updated each quarter to reflect newly released HCPCS codes. These “Not-otherwise-classified codes” (e.g. C9399) should only be used when a more specific HCPCS code has not been assigned. **Please note that the FDA approves new drugs daily. If a “new drug” has been approved since our list was last updated, please submit a question to us via our CONTACT USpage. We’ll research the drug and respond. What do I need to know about billing with C9399? HCPCS code C9399 is billed with a quantity of “1” (one) on the claim which is essentially a placeholder and directs the payer to review additional information in the NOTES/REMARKS section of the 837I claim. For Medicare and some other payers, discarded waste from separately payable single-dose vials must be recorded in the patient’s medical record. When reporting C9399, a separate charge line on the claim with the JW modifier should NOT be reported. Instead the amount administered and amount wasted (if documented) is reported in the NOTES/REMARKS section of the claim. For Medicare outpatients, when reporting C9399, hospitals must also report the National Drug Code (NDC) and quantity administered (expressed in the NDC unit of measure) as well as the date the drug was furnished in the NOTES/REMARKS section. For Medicare outpatients, the MAC will manually calculate the payment for the drug or biological at 95 percent of the average wholesale price (AWP). The MAC will pay 80 percent of the calculated payment to the hospital and the beneficiary will be responsible for the 20 percent co-pay after the deductible is met. Drugs/biologicals manually priced at 95 percent of AWP are not eligible for outlier payment. Other payers may pay similarly to Medicare or have an established fee schedules for new drugs. Some payers may provide alternate billing instructions (e.g. J3490, J3590) and they should be followed when available. Please note that physician offices are not eligible to bill using HCPCS codes beginning with “C”, and must select a different unclassified code, e.g. “J” code. (Transmittal R976CP, June 9, 2006) Why have some drugs been approved for years, and still don’t have a HCPCS code assigned? The HCPCS Workgroup assigns HCPCS code quarterly and holds an annual Public Meeting to gain feedback on their preliminary decisions. Typically a manufacturer or insurer submits an on-line application requesting a HCPCS code assignment. Approved codes are posted on the CMS HCPCS Quarterly update page. What else should I know about these drugs that don’t have an assigned HCPCS code? Medicare may consider some of these drugs that are administered subcutaneously as “self-administered” and therefore not covered in a hospital outpatient department. For other payers, the drugs may be covered in a hospital outpatient department, or covered as a pharmacy benefit rather than the medical benefit. Medicare has also provided different instructions for billing diagnostic radiopharmaceuticals and contrast agents when a specific code has not been assigned. These instructions are available in the January 2017 OPPS update. Shoutouts! Pharmacy should review these 46 C9399-eligible drugs to determine if they are in use and if so, ensure that the HCPCS code C9399 is used for billing with revenue code 636. (Exception: Brexucabtagene autoleucel (Tecartus™) should be reported in revenue code 891). Finance should review payments for C9399 to determine if payers are reimbursing at 95% AWP (Medicare and payers like Medicare), or at a contracted fee schedule rate. Revenue Integrity should review any drugs in use to ensure they are not on the facility’s“Self-Administered Drug” listingfrom the MAC, and therefore not covered when furnished in a hospital outpatient department. Managed Care Contracting should ensure that all “new” drugs are covered in contracts and reimbursed as a percentage of AWP, percentage of charges, or identified in separately paid fee schedules.

05 // Let’s Talk About Billing Drug Waste

10-12-2020

Have you ever questioned… “Is charging for waste worth the effort?” “Am I required to charge for drug waste?” “My organization states we have been charging for waste for over... a decade, what is all the hoopla for now?” Billing for the waste of drugs and biologicals has been embedded in the CMS manuals for many years. CMS has always encouraged providers to administer drugs in a manner that minimizes waste when clinically appropriate. For example, providers may consider scheduling patients in a way that allows multiple patient doses prepared from the same vial(s) reducing any waste. However, the direction on billing drug waste has been left murky. In 2007 CMS revised their manual to include language surrounding discarded drugs and biologicals. Educational material and information directed by the Medicare Administrative Contractors (MAC) was unclear and contractors inconsistently mandated the use of the JW modifier (Drug amount discarded/Not administered to any patient). In 2016 CMS attempted to require the use of the JW modifier but rescinded the change requests several times pushing back the effective date. Finally, effective January 1, 2017, CMS implemented a change to Section 40 – Discarded Drugs and Biologicals of Chapter 17 of the Claims Processing Manual 100-04. The change requires the use of a JW modifier to identify unused portions of a single dose vial or package for Part B drugs and biologicals. Additionally, the unused drug or biologics must be properly discarded and documented in the patient’s medical record. CMS has published an FAQ that provides more answers to specific questions. Listed below are a few key points to take into consideration. If the provider (hospital or supplier) seeks payment for the billed waste, the JW modifier is required for separately payable drugs or biologics. These are identified by the status indicator of G (Pass-Through Drugs and Biologicals) or K (Nonpass-Through Drugs and Biologicals). Status indicator N (items or services packaged into APC rates) drugs are not required to report the JW modifier. The unused drug or biologic must be reported on a separate line on the claim with a JW modifier and appropriately reflect the amount of drug waste in terms of billed units. CMS does not allow for fractional billed units; thus, when the wasted portion of the vial is less than 1 billed unit the waste should be left off the claim. Example: Patient X was administered cyclophosphamide 1450 mg dose with 50 mg of waste. The medical record documented the use of a 1,000 mg vial and a 500 mg vial to create the dose. This resulted in 50 mg of waste in the medical record. Cyclophosphamide represents 100 mg per billing unit. The 50 mg of waste are less than the one billed unit; thus, cannot be reported on the claim. The dose of 1450 mg will be rounded up to 15 billed units on the claim and accounts for all the billing units in the vials. Billing for waste in the scenario would represent overbilling as the 50 mg would also round up to 1 billing unit totally 16. Shoutouts! “Is charging for waste worth the effort?” YES! Organizations should work with their finance team or analyst to help determine the annual net revenue impact on your high cost drugs. Waste is inevitable and can lead to large amounts of revenue leakage for not charging. “Am I required to charge for drug waste?” Not necessarily. However, if you are seeking payment for the unused portion of a drug or biologic it is required that you identify the line appropriately with a JW modifier. “My organization states we have been charging for waste for over a decade, what is all the hoopla for now?” It is great if your organization has already developed a mechanism to apply the JW modifier; however, the regulations effective January 1, 2017 expanded the direction to all MACs to require the use of the JW modifier for unused portions of a single use vial or package for Part B drugs and biologicals AND documentation in the medical record must support the billed waste.

04 // October 2020 Quarterly code updates

10-05-2020

This edition of Pharmacy Revenue Cycle News is a compilation of all quarterly resource files that detail code changes pertinent to drug billing effective October 1, 2020. Here’s a listing... of the files and a short description of what each one contains. We recommend that pharmacy, finance, and revenue integrity review all files for changes pertinent to drugs in use at the facility, and update their IT systems to reflect the current information. We have three shoutouts; two pertain to reviewing previous claims for potential rebilling, and also an evaluation of formulary status for drugs with status indicator changes regarding separate payment. October 2020 OPPS Update Revised update posted on September 24 with HCPCS code changes (Section 8, page 5 of pdf file) MLN Matters: OPPS Update Educational materials for health care professionals on CMS programs, policies, and initiatives Outpatient Code Editor (OCE) Release Files Summary of code changes used to edit Medicare outpatient claims Addenda A and B Provide payment rates for all services under OPPS (Hospital Outpatient and Ambulatory Surgery Centers October 2020 Restated Payment Rates Corrected payment rates for two HCPCS codes (Q5107-Mvasi and J1557-Gammaplex) Medically Unlikely Edits (MUE) Maximum units of service expected for a single beneficiary on a single date of service per HCPCS code October 2020 ASP Drug Pricing Files ASP Pricing File– Payment rates for drugs with Column J indicating new additions, “Added October 2020” NOC Pricing File– Payment rates for select drugs which have not been assigned a HCPCS code October 2020 Drug NDC-HCPCS Crosswalks ASP NDC-HCPCS Crosswalk– all drugs with assigned HCPCS codes that are used in HOPD, ASC, and physician offices OPPS NDC-HCPCS Crosswalk– for assigned codes used only in HOPD and Ambulatory Surgery Centers (ASC) NOC NDC-HCPCS Crosswalk– for Not Otherwise Classified (NOC) codes AWP NDC-HCPCS Crosswalk– for flu, pneumonia, hepatitis B and albumin when paid on an AWP basis CMS Medicaid Drug Rebate File (most recent file is for 2ndQU 2020) Listing of National Drug Codes (NDC) covered under State Medicaid Programs AMA- CPT Codes for Vaccines New codes are published in January and July, therefore no update in October AMA- Annual CPT code release New codes are released in January, therefore no update in October FY2021 ICD-10-CM and ICD-10-PCS codes Annual code release for diagnosis, and inpatient procedure codes Shout-outs! 1. The Finance Team will want to review previous claims with retroactively revised status indicators. For this quarter, the status indicator for HCPCS code Q5121 (Injection, infliximab-axxq, biosimilar, (avsola), 10 mg) for the period of July 6, 2020 through September 30, 2020 will be changed retroactively from status indicator =”E2” to status indicator = “K” indicating that it will now be separately paid from its FDA approval data of July 6. Facilities who administered Avsola during the 3rd quarter should review outpatient claims to determine if they received payment, and if not, consider rebilling claims to recoup the additional payment. This may impact Medicare, Medicaid, TRICARE, and commercial payers with rate schedules similar to Medicare. 2. The Finance Team will want to review previous claims with two HCPCS codes that have restated payment rates. For October 2020, two drug HCPCS codes are listed with restated payment rates (Q5107-Mvasi and J1557-Gammaplex). Depending upon the significance of the difference and usage volumes, a facility could choose to rebill previously submitted claims to receive any additional payment. For J1557, payment rates have been adjusted back to April 1, 2020. For Q5107, the payment rate has been adjusted to July 1, 2019. 3. Pharmacy and P&T Committee should review the OPPS Update and Addendum B to identify any drugs which will now receive separate payment and those with separate payment expiring to determine if the formulary status of these drugs should be re-evaluated. (Section 8, page 5 of the pdf file).

03 // TRICARE NTAP and Investigational Drugs related to COVID-19

09-28-2020

The Department of Defense published an Interim Final Rule in the Federal Register on September 3, 2020 with two provisions which directly impact payment for drugs on TRICARE inpatient and outpatient claims. ... The first provision is that TRICARE will adopt the payment criteria and formulas for new technology add-on payments (NTAP) as outlined in CMS Inpatient Prospective Payment System (IPPS) Final Rule. This is a new payment provision and will be made retroactive to January 1, 2020. In the future, TRICARE will adopt CMS’s effective date of October 1 of each year. This is listed as a permanent change. For a tool listing the FY2020 and FY2021 drugs eligible for CMS NTAP payments (and now applying to TRICARE), see: NTAP Tool. The second provision is a temporary provision where TRICARE, for the first time, will cover not just the care associated with administration of an investigational drug, but the investigational drug itself, when the investigational drug is for the treatment of COVID–19 or its associated sequelae. This use may be authorized in any setting for which the FDA allows treatment use of an investigational drug under expanded access to proceed. The change under this provision is temporary for the duration of the President’s national emergency for the COVID–19 outbreak, but the drug may continue to be covered beyond the national emergency if the course of treatment was started prior to the end of the national emergency. TRICARE indicated that it intends to use this national emergency period to re-evaluate their current exclusion on coverage of treatment INDs and may revise the regulation to cover investigational drugs for treatment use under expanded access for all indications if appropriate after they evaluate the costs, benefits, risks, and other considerations. Coverage for investigational drugs may impact both inpatient and outpatient TRICARE claims as the charges may contribute to outlier payments and there may be additional separate reimbursement on outpatient claims depending upon the cost incurred by the facility. TRICARE has 9.4 million beneficiaries who receive healthcare in a network of civilian providers and military hospitals and clinics. TRICARE beneficiaries are the men and women of the Armed Forces and their families including active duty and retirees, as well as National Guard and Reserve members SHOUTOUTS! The Finance Teamwill want to review all FY2020 CMS NTAP-eligible drugs to determine if any were used on TRICARE inpatients with claim dates on or after January 1, 2020. The appropriate ICD-10-PCS codes should be added if not already on the claim and rebilled to TRICARE. The Finance Teamwill want to include TRICARE accounts in any edits or monitoring for FY2021 NTAP drugs (similar to their current process for Medicare), to ensure that appropriate ICD-10-PCS codes are added to the claim. ThePharmacy and P&T Committeeshould include Medicare and TRICARE data when evaluating NTAP-designated drugs for formulary status.

02 // New Technology Add-on Payments (NTAP)

09-21-2020

Question: “Don’t all inpatient claims receive the same fixed payment based upon the diagnosis? Why should I itemize charges on an inpatient?” Answer: “YES; you should itemize because you may... receive extra reimbursement in addition to the MS-DRG payment.” One scenario that generates extra payment is when services, (including drugs) are used on inpatients that are designated for New Technology Add-on Payments (NTAP). Next question: “What do I need to do to receive the extra payment?” The medical record must contain a valid order for the drug, The medical record must contain documentation of the administration of at least one dose, and, The appropriate ICD-10-PCS code for the administration of the drug must be added to the claim. For FY2021, effective October 1, 2020, nineteen drugs are eligible for maximum NTAP payments ranging from $1014.79 to $125,448.05 per case. Eligible drug products for FY2021 are summarized in the attached tool with the maximum reimbursement per case and the related ICD-10-PCS codes listed. 9 products were continued from last year (Zemdri, AndexXa, Azedra, Cablivi, Elzonris, Balversa, Spravato, Xospata and Jakafi) 3 are newly approved with the normal pathway (Imfinzi, Tecentriq, and Soliris) 5 newly approved Qualified Infectious Disease Products (QIDP) (Fetroja, Nuzyra, Recarbio, Xenleta, Zerbaxa) 1 QIDP that has not yet been approved by the FDA but received conditional NTAP approval: Contepo. ◦Contepo will be eligible for NTAP payment effective for discharges the quarter after the date of FDA marketing authorization provided that the technology receives FDA marketing authorization before July 1, 2021. Six drugs that were previously eligible for NTAP payments will no longer be eligible as of October 1, 2020: Kymriah/Yescarta, Vyxeos, Vabomere, Giapreza, Erleada). NTAP payments are approved annually by CMS. On a per claim basis, Medicare makes an add-on payment equal to the lesser of: 65 percent of the costs of the new medical technology (as established in the IPPS Final Rule), or 65 percent of the amount by which the costs of the case exceed the standard DRG payment (with costs being calculated based upon the hospital’s cost-to-charge ratio). Note: Drugs approved under the QIDP pathway use 75 percent rather than 65 percent in the calculations. Since the total charges on the claim are used for the calculation, it is important that all eligible services, including all drugs, be separately reported so that they are counted in the total charges. This includes anesthesia agents, contrast agents, IV fluids and other drugs which may be overlooked. The application process starts with the manufacturer applying to CMS for the designation which may result in 2-3 years of additional payment. For FY2022, the application deadline is October 16, 2020. In order to be eligible for NTAP, the technology must meet three criteria. It must be: new costly, such that the DRG rate otherwise is determined to be inadequate; and a substantial clinical improvement over existing services or technologies. Note: Drugs approved under the QIDP pathway are deemed to meet the “newness” and “substantial clinical improvement criteria” and therefore only need to meet the cost criteria for NTAP eligibility. Shoutouts! The Pharmacy Director should have a general understanding of which drugs are awarded NTAP status each year so that it can be used in formulary decision-making. The NTAP process was implemented to encourage medical innovation, so that new technology would have a 2-3 year period when physicians could use the drugs with additional reimbursement to see if they had advantages over older therapies. The Finance Team should work to ensure that when these drugs are administered to inpatients, the claims are identified and held to ensure that the coders can review them and get the appropriate ICD-10-PCS codes on the claim before they are final billed. Either a HCPCS code or NDC number would be a good way to identify usage in the system and stop the claim for coding prior to the final bill being released. The Finance Team will want make sure that each time an NTAP drug is administered to an inpatient, the ICD-10-PCS code is verified on the claim. With the claim payment, the payer is required to add value code 77 to the remittance advice which indicates the additional payment for NTAP. Each drug administration should be tracked all the way through to the payer and back to the payment received to ensure that if eligible, NTAP money is received as expected. Since some drugs will have their NTAP designation expire on October 1, it would be good to have the P&T Committee review previous usage and outcomes and determine if the drug’s formulary status should remain the same or be revised.

01 // Influenza Vaccines

09-12-2020

Healthcare organizations are being asked to manage ventilators, drug shortages, establish telehealth services, manage a budget, and downsize staff among other tasks amid the pandemic. You may leave the day... feeling as if you were Thor conquering the Nine Realms. The Pharmacy Revenue Cycle Newsletter aims to put the Mjölnir (hammer of Thor) into your hands and provide you with helpful tips, resources, and emerging updates that can improve your pharmacy revenue. “Pharmacy Revenue Cycle” (www.pharmacyrevenuecycle.com) is brought to you by Agatha Nolen, Ph.D., CRCR, FASHP and Maxie Friemel, PharmD, MS, BCPS, CRCR. Together we bring over 25 years of experience working with CFO’s, pharmacy directors, billing & charge master teams, informatics, and alike. Recognizing organizations’ gaps in understanding the pharmacy revenue cycle and the increasing impact pharmaceuticals have on our budget, our goal is simple. We take complex and ever changing rules and regulations, bring you awareness and practical tools that can help you understand and enhance your pharmacy revenue cycle. Each year the influenza season brings about its own challenges from distribution to billing. In the midst of a pandemic, influenza billing may seem trivial which is more the reason a simplified tool could boost your accuracy. For our debut of the Pharmacy Revenue Cycle Newsletter and website, we bring you an Influenza Billing Tool. The influenza tool extracts the influenza products and packages from the CDC. This information is then mapped to available CMS Flu Shot Coding which contains the HCPCS/CPT and descriptions for each vaccine. When mapping NDC to CPT codes, caution is taken to ensure accuracy based upon dosage, valency, formulation (e.g. MDV, SDV) among other attributes of each individual product. Lastly, we have included the CMS payment allowance which is calculated at 95% of AWP. This is the estimated reimbursement for Medicare Part B beneficiaries with the exception of Hospital Outpatient Departments which are paid at reasonable cost. Shoutouts! Sanofi Pastuer has developed a high dose formulation that is dosed at 0.7 mL versus the traditional 0.5 mL. CPT code 90662 will be used to code this product, but is the same code as previous years 0.5 mL dosage. Ensure the CDM or billing crosswalks reflect the updated 0.7 mL per billed units or is based on a per dose and only 1 billed unit is calculated per dose. CPT 90686 and 90685 differ only by the dosage administered but often represent the same NDC. Validate that your system produces the correct CPT based on the dose administered.

Pharmacy Revenue Cycle

92 // Heavy Hitters for the July Quarterly Updates

91 // Beat Inflation with a Part B Rebate

90 // Don’t be “SAD”… An Alternative Way to Handle Self-Administered Drugs