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.