On May 17, 2021, the Health Resources and Services Administration (HRSA) sent letters to six drug manufacturers notifying them that their actions placing restrictions on access to 340B-discounted drug prices by health care...more
On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more
12/3/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Manufacturers ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors
Members of Congress of both parties are requesting that the Department of Health and Human Services (HHS) take action to ensure that providers participating in the 340B drug pricing program can continue to receive discounted...more
On August 4, 2020, CMS issued a proposed rule to further reduce outpatient drug payment rates under Medicare to certain hospitals participating in the 340B drug pricing program. As part of the 2021 OPPS Proposed Rule, CMS...more
Conversations also continue regarding the 340B drug pricing program, which requires drug manufacturers to sell outpatient drugs at discounted prices to safety net providers, including certain public and private non-profit...more
Both Congress and the White House continue to push for bipartisan action to address high drug prices, with hopes of enacting legislation as part of a spending package that must pass by May 22, 2020....more
The D.C. Circuit Court of Appeals has scheduled oral arguments for November 8, 2019 in the ongoing lawsuit challenging Medicare payment cuts to hospitals in the 340B drug pricing program. The court is considering an appeal by...more
Both the House and Senate are expected to consider legislation to address high drug prices when Congress returns. Meanwhile, the Administration has faced roadblocks to several of its high-profile proposals to address drug...more
Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more
12/13/2018
/ Affordable Care Act ,
Civil Monetary Penalty ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
Health Care Providers ,
Hospitals ,
HRSA ,
Manufacturer Liability ,
Office of Pharmacy Affairs Information System (OPAIS) ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
The Government Accountability Office (GAO) issued a report on June 28, 2018 regarding federal oversight of compliance at 340B program contract pharmacies. The 340B drug pricing program requires drug manufacturers to sell...more
On Friday, May 11, President Donald Trump and Department of Health and Human Services (HHS) Secretary Alex Azar presented the Administration's long-awaited plan to address drug pricing. The proposed framework, entitled,...more
The Department of Health and Human Services (HHS) is soliciting comments from the public on the Administration's proposals to reduce drug prices and is targeting the 340B drug pricing program as an area of focus. ...more