Medicare to Cover PrEP and Associated Services Under Part B Only
CMS announced that it expects to release a final National Coverage Determination (NCD) late next month that will move the PrEP coverage benefit from Medicare Part D to Medicare Part…
Two Covered Entity Hospitals Sue HRSA Over Johnson & Johnson Request for Audit
On July 24, 2024, two hospital-covered entities sued the Health Resources and Services Administration (“HRSA”), arguing that HRSA’s approval of J&J’s 340B audit request against them was unlawful and premature. The…
Alkermes and Viatris Impose 340B Program Contract Pharmacy Restrictions
Alkermes and Viatris have become the 36th and 37th manufacturers, respectively, to impose restrictions on contract pharmacy arrangements. These restrictions are effective July 22 and August 1, respectively, but please…
RWC-340B Signs Onto Joint Letter Providing Draft Guidance on the Inflation Reduction Act (IRA)
RWC-340B was asked to sign onto the attached letter to CMS commenting on its May 3, 2024 Draft Guidance implementing aspects of the Inflation Reduction Act (IRA). 340B Health drafted the…
RWC-340B Submits Comments to Senate 340B Working Group
RWC-340B carefully reviewed the draft legislation, explanatory statement, and supplemental request for information (RFI) that the Bipartisan 340B Senate Working Group (Working Group) shared with 340B stakeholders on February 2,…
Amgen Applies Contract Pharmacy Restrictions to Federal Grantees
Beginning March 19, 2024, Amgen will apply its contract pharmacy restriction policy to all covered entity types, including previously exempted federal grantees. Amgen’s policy applies to self-administered Amgen products—Repatha®, Enbrel®,…
Senate Working Group Releases SUSTAIN Act Discussion Draft of 340B Legislation
RWC-340B welcomes the release of the bipartisan Senate Working Group on 340B’s legislative discussion draft of the “SUSTAIN 340B Act.” The draft bill – formally titled, the Supporting Underserved and Strengthening…
RWC-340B Sends Letter of Support in Whistleblower Suit Alleging Manufacturer Overcharges
On January 24, 2024, RWC-340B sent a letter of support in connection with a False Claims Act case that, if successful, could clear a pathway for Ryan White clinics (RWCs)…
Gilead Expands Claims Submission Requirements to Wholly-Owned Contract Pharmacies; Government Declines to Appeal Genesis Patient Definition Decision; Egwim Steps Down as Director of OPA.
Gilead Expanded Policy Gilead expanded its existing restrictions on contract pharmacy arrangements, effective January 30, 2024, but only for covered entities that dispense 340B drugs through wholly-owned contract pharmacies. Gilead’s…
CMS Defers Decision on Part D 340B Modifier Proposal
CMS published revised guidance on December 14, 2023 to defer its decision to require 340B point-of-sale modifiers for Part D drugs beginning in 2026. RWC-340B submitted comments to CMS’s initial proposal…