Billing for Pharmacists’ Services provided in a Hospital Outpatient Department 3/1/21

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.

Note: Other payers may not recognize HCPCS Code G0463 and instruct that hospital clinic visits for pharmacist-managed services be billed with CPT codes 99211. In this scenario, payer instructions should be followed.

5. Items and services that are billed to any governmental payer (e.g. Medicare, TRICARE) must be “medically necessary”. 

• Current language on Healthcare.gov defines “medically necessary” as “health care services or supplies needed to diagnose or treat an illness, injury, condition, disease or its symptoms and that meet accepted standards of medicine”.

• Chapter 13, Section 13.5.4 of the Medicare Program Integrity Manual provides directions to the Medicare Administrative Contractors (MACs) that only items and services that are reasonable and necessary can be covered, and provide the following elements to support “reasonable and necessary”:

  • Safe and effective

  • Not experimental or investigational (with limited exceptions for routine costs in qualifying clinical trial services meeting NCD requirements)

  • Appropriate, including the duration and frequency that is considered appropriate for the item or service in terms of whether it is: 

    • furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member; 

    • furnished in a setting appropriate to the patient’s medical needs and condition; 

    • Ordered and furnished by qualified personnel

    • One that meets, but does not exceed, the patient’s medical need

    • At least as beneficial as an existing and available medically appropriate alternative. 

• In the past, some Medicare Administrative Contractors (MACs) have provided guidance to individual facilities that if the sole purpose of a visit is to draw blood or give an injection, then the visit code should not be billed if it is the only service rendered. Some health-systems have interpreted that to mean that if the INR is in the appropriate range and there is no change in the medication dosage that the clinic visit should not be billed, but that is not the stated position from CMS. For example, during the visit, the patient may voice concerns to the pharmacist, e.g. side effects of the medication, changes in dietary habits or nutritional supplements or issues with compliance. In this case, the pharmacist should document the patient history, any exam, the presenting problem, recommendations to resolve the problem (including education provided) and communication to the referring physician or other caregivers such as a retail pharmacist or dietician. In other cases, the timeframe for the therapy has been completed and the referring physician is contacted to discontinue the anticoagulant. In these limited examples, medical record documentation may help support the billing of an outpatient clinic visit as medically necessary even when the dosage of the medication is unchanged or the medication is no longer continued.

6. In 2019, a health system paid a $3 million settlement and entered into a CIA agreement for allegations that they were billing for services that were not medical necessary from an anticoagulation clinic. (The claims resolved by this settlement were allegations and the settlement was not an admission of liability by the health system, nor a concession by the United States that its claims are not well founded). The 5-year CIA agreement accepted by the OIG of HHS included specific information for auditing. In addition to reviewing other hospital department claims, anticoagulation clinic claims were particularly specified. The Independent Review Organization (IRO) would review a sample of 50 paid claims from the Anticoagulation Clinic from all paid claims for oral anticoagulation therapy for the 12-month period covered by the claims review period. 

SHOUT-OUTS

Using a pharmacist-managed anticoagulation clinic as an example, we recommend the following to substantiate billing for a clinic visit for pharmacists’ services in the hospital outpatient department:

✅ Pharmacy, Compliance and Legal should review scope of practice provisions in state pharmacy and medical board rules and regulations to determine if special credentialing, collaborative practice agreements, or other criteria must be met to provide the services. Processes should be developed to ensure that all practitioners providing cognitive services have appropriate credentials or signed agreements, credentialing is tracked, and that if credentials or agreements are time-limited (i.e. expire) that a process is in place to ensure that they are updated/renewed prior to expiration so there are no gaps in patient services.

✅ Pharmacy, Compliance and Legal should review State rules and regulations pertaining to the provision of pharmacist-managed services and ensure that all requirements are met in appropriate timelines. For example, if a State requires that a Collaborating Physician review the patient’s progress every 6 months, IT systems should be set with reminders and charts audited periodically to ensure that medical record documentation for each patient supports State rules and regulations.

✅ Pharmacy, Compliance and Legal should review existing agreements particularly for State Medicaid programs that may provide for monthly reimbursement for the total management of medications. If patients are covered under these reimbursement models and payment is made to other pharmacists, these payers should not be billed again for similar services provided in the hospital outpatient department.

✅ Pharmacy, Compliance and Revenue Integrity should meet and approve criteria and medical record documentation required for the appropriate billing of G0463 for Medicare outpatients based upon accepted “standards of medical care” and that demonstrate medical necessity. Ideally policies, protocols and algorithms should be approved by Medical Staff Committees and dates of approvals available when audits are performed or medical record requests are made by the payer. Elements that should be considered in developing criteria include:

• Medical Record statement documenting that service is provided in compliance with state scope of practice for a pharmacist (and credentials of rendering provider) and under a Collaborative Practice Agreement (if required)

• Frequency of patient visits compared to national standards of care and criteria in which frequency should be increased or decreased

• Documentation of need for hospital visit compared to physician office visit or at-home INR monitoring, (i.e. what are the patient’s needs or condition that make this the appropriate setting?)

• Order from a qualified healthcare provider for monitoring services (e.g. referral) and order, or intention to order from a qualified healthcare provider for any laboratory values required for monitoring

• Medical Record statement as to how this service is meeting the patient’s needs (but not exceeding them)

• Uniform facility-specified documentation of clinical services provided, including education, referrals to other practitioners, updates to referring physician and updates to supervising physician. This could be in a S-O-A-P format or the nationally-endorsed Pharmacists’ Patient Care Processes, or other recognized format.

• Hospital claims should include the National Provider Identification (NPI) number of the physician who is providing general supervision of the pharmacists’ services in the hospital outpatient department as required under OPPS. General supervision means that “the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure.”

✅ Pharmacy and Managed Care Contracting should meet with payers to include language in negotiated contracts and supplemental policies which provide reimbursement for pharmacists’ services in hospital outpatient departments based upon Medical staff approved standards of care, agreed upon medical record documentation and reimbursement rates.

✅ Pharmacy and Internal Audit should consider auditing a sample of 50 paid claims every 12 months to ensure that all payer specifications are met to substantiate the services billed and audit results maintained to provide evidence of sound billing practices.