Recent Blog Posts
- CMS Finalizes Policy and Technical Changes to the Medicare Advantage and Part D Programs for CY 2019 The Centers for Medicare and Medicaid Services (“CMS”) issued on April 2, 2018, an advanced copy of the final rule title “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” (“Final Rule”). This Final Rule will be published in the April 16, 2018 issue of the Federal Register.
This Final Rule implements provisions of the proposed rule that CMS released titled “Medicare... More
- White House 2019 Budget and White Paper Shape Ambitious Policy to Reduce Drug Prices Over the past week, the White House administration (the “Administration”) has issued two documents addressing drug pricing. First, on February 9, 2018, the White House’s Council of Economic Advisers released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad” (the “White Paper”). Second, on February 12, 2018, the Administration issued its 2019 Budget Proposal (“2019 Budget”).
Whereas the recommendations set forth in the White Paper are more conceptual or exploratory, the 2019 Budget purportedly reflects the Administration’s more specific... More
- CMS Final Rule Will Reduce Medicare Part B Drug Payments by Nearly 30% for 340B Hospitals On November 1, 2017, the Centers for Medicare & Medicaid Service (“CMS”) released the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) final rule (“Final Rule”), finalizing a Medicare payment reduction from Average Sales Price (“ASP”) + 6% to ASP – 22.5%, for 340B discounted drugs in the hospital outpatient setting, as was proposed in the OPPS proposed rule earlier this year. This payment reduction is effective January 1, 2018, and would primarily impact disproportionate share hospitals, rural referral centers, and... More
- U.S. District Court Vacates HRSA’s Interpretative Rule on Orphan Drugs On Wednesday, October 14, 2015, the U.S. District Court for the District of Columbia (the “Court”), Judge Rudolph Contreras, vacated the Health Resources and Services Administration’s (“HRSA”) interpretive rule on Orphan Drugs (“the Interpretative Rule”) as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” As a result of the ruling, pharmaceutical manufacturers are not required to provide 340B discounts to certain types of covered entities for Orphan Drugs, even when the drugs are prescribed for... More
- HRSA Issues Proposed “Omnibus Guidance” The Health Resources and Services Administration (“HRSA”) issued a notice proposing guidance under the 340B Drug Pricing Program. The proposed Omnibus Guidance was issued in pre-publication format and is available online at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-21246.pdf. The notice is scheduled to be published in the Federal Register on August 28, 2015 and will be available at https://www.federalregister.gov/articles/2015/08/28/2015-21246/guidance-340b-drug-pricing-program-omnibus.
HRSA intends to finalize the proposed guidance after consideration of public comments. The notice is open for a 60-day public comment period, with comments due on or... More
- House Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady
The House of Representatives Energy and Commerce Committee (“the Committee”) circulated draft language to include in its 21st Century Cures legislation earlier this week to reform the 340B drug discount program (the “340B Program”). Although the draft 340B language was pulled from the legislation yesterday, the language proposed provides insight into what future legislative reform may include. The draft language, if adopted, would have a substantial impact on all 340B... More
- Members of House Subcommittee Express Support for the 340B Program, but Need for Clarity, Oversight and Transparency On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee (the “Subcommittee”) held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and Services Administration (“HRSA”), the Director of the Office of Pharmacy Affairs (“OPA”) of HRSA, the Director of Health Care of the Government Accountability Office (“GAO”), and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General... More
- HRSA Withdraws 340B “Mega-Reg;” Plans to Issue Guidance in 2015 On November 13, 2014, the Health Resources and Services Administration (“HRSA”) announced its plans to abandon the much anticipated “mega-reg” amid questions concerning HRSA’s rule-making authority. The “mega-reg” was expected to provide much needed clarity to the 340B drug discount program (the “340B Program”) by addressing, among other things, the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility, and criteria for hospital off-site facilities.
HRSA submitted draft regulations to OMB in April 2014, and the proposed “mega-reg”... More
- HRSA Issues Interpretive Rule on 340b Orphan Drug in Response to Court Vacating Final Rule By Constance Wilkinson, Alan Arville, and Jonathan Hoerner
On July 23, 2014, the Health Resources and Services Administration (“HRSA”) issued an “interpretive rule” entitled “Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities under the 340B Program” (the “Interpretive Rule”). The Interpretive Rule follows the ruling by the U.S. District Court for the District of Columbia on May 23, 2014, that vacated the final rule previously released by HRSA on the treatment of orphan drugs under the 340B program... More
- Major Themes at 340B Coalition Winter Conference Include Contract Pharmacy Oversight, Medicaid Managed Care, and Anticipated 340B “Mega-Reg” By Alan J. Arville
Last week, the 2014 340B Coalition Winter Conference was held in San Diego, California (the “Winter Conference”), where representatives from the Health Resources and Services Administration (“HRSA”) of the United States Department of Health and Human Services (“HHS”), the Office of Inspector General (“OIG”) of HHS, and industry stakeholders (including Epstein Becker Green) presented on current developments with the 340B drug discount program (the “340B Program”). A brief summary of the 340B Program, including contract pharmacy arrangements,... More