Visante 
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.
