July 2021 Comes with a Star-Spangled Bang- CMS Quarterly Update 6/28/21

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. 

1. New HCPCS

   1. 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.

   2. Two new HCPCS codes that are replacing temporary codes that are being discontinued. 

   3. One new HCPCS code not eligible for pass-through status

   4. 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

1. 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).

2. 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

1. 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. 

1. COVID-19 vaccine and administration code revisions to the I/OCE

   1. Bamlanivimab and administration of Bamlanivimab codes will be deleted. Please reference our previous newsletter on “Covid Infusion Confusion”.

   2. 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).

   3. 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. 

Shout Outs!

1. Pharmacy and Revenue Integrity Teams should develop a process in which information is routinely being reviewed and evaluated on a quarterly basis. 

2. Pharmacy informatics and Chargemaster should coordinate efforts to ensure all internal build is update by the beginning of each quarter including new or changed HCPCS and changes in status indicator impacting the 340B TB and JG modifier application.