by keith | Nov 1, 2017 | 340B, News and Updates, Rulemaking
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...
by keith | Jul 20, 2017 | 340B, News and Updates
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...
by keith | May 18, 2017 | 340B, News and Updates, Rulemaking
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...
by keith | Jan 31, 2017 | 340B, News and Updates
Jan. 31, 2017: HRSA has withdrawn its 340B Program Omnibus Guidelines.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...
by keith | Sep 1, 2016 | 340B, News and Updates
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.
