HRSA furthered delayed implementation of a final rule codifying the calculation of the 340B ceiling price, and implementing civil monetary penalties for manufacturers that knowingly and intentionally overcharge 340B providers. The final rule had been published on January 5th under […]
In its proposed rule implementing changes to the Medicare Outpatient Prospective Payment System, CMS has proposed to reduce payments to hospitals for separately payable drugs that are eligible for discounts under the 340B Drug Pricing Program. Specifically, CMS would reduce […]
HRSA issued a rule further delaying until October 1, 2017, the implementation of a January 5th final rule codifying the calculation of the 340B ceiling price, and implementing civil monetary penalties for manufacturers that knowingly and intentionally overcharge 340B providers. A […]
Jan. 31, 2017: HRSA has withdrawn its 340B Program Omnibus Guidelines. HRSA’s Office of Pharmacy Affairs (OPA) first issued the guidance, which would have dramatically restricted key elements of the program, in August 2015. OPA submitted the final version of the […]
September 1, 2016: The 340B Omnibus Guidance notice is back at the Office of Management and Budget for review before issuance, just over a year after publication of the proposed version of the notice.
August 11, 2016: HRSA Proposes Dispute Resolution Process for 340B Discount Program
CMS Finalizes Requirement that States Conduct Medicaid Access Reviews, Excludes Regular Reviews of Access to Hospital Services
MACPAC issues congressionally-mandated report on Medicaid DSH, recommends better targeting of funds to hospitals most in need.
OIG Release 2016 Workplan; Includes Reviews of Hospital Provider-Based Status, Medicaid Provider Taxes and Medicare Payment for 340B Discounted Drugs
DC District Court overturns HRSA’s 340B guidance on orphan drug exclusion, applying less deference to the agency’s interpretation of the 340B statute; possible implications for proposed mega-guidance.