Tracker Entry #: 15
Document Category: Rule
Citation/Location:

86 FR 10181/ pp.10181


Relevant Dates:

Published 2/19/2021


Agency Actions: Final Rule
Summary:

Background/Summary: After a court-ordered delay of effective date on a final rule by HHS. This final rule detailed regulatory safe harbors to the Federal anti-kickback statute. On January 12, 2021, a lawsuit was filled to challenge this final rule and on January 30, 2021 the court ordered a postponement of the effective date of the provisions. The effective date of the amendments to paragraph 42 CFR 10001.952 (h)(5) to the final rule are now effective on January 1, 2023.


Analysis/ Additional Details:

This is a final notice with no comment period. WATCH for further developments.
https://www.federalregister.gov/documents/2021/02/19/2021-03167/fraud-and-abuse-removal-of-safe-harbor-protection-for-rebates-involving-prescription-pharmaceuticals
Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Delayed Effective Date