340B omnibus guidance withdrawn

Feb 01, 2017 - 03:30 PM

The administration yesterday withdrew the Health Resources and Services Administration’s pending omnibus guidance for the 340B Drug Pricing Program. “We are pleased that the Administration chose not to finalize the Health Resources and Services Administration’s guidance, which, if enacted would have jeopardized hospitals’ ability to serve vulnerable populations, including low-income and uninsured individuals and patients receiving cancer treatments,” said AHA Executive Vice President Tom Nickels. AHA previously expressed strong concerns regarding HRSA’s proposed policy changes, stating that re-defining 340B patient eligibility would have narrowed inappropriately the number of drugs that qualify for 340B pricing and threatened access to care for patients who need it the most. In addition, AHA objected to HRSA’s proposals regarding infusion services, and urged that patients receiving infusion services provided at 340B hospitals or their outpatient sites be allowed to continue to qualify for 340B drug discount pricing. 

Related News Articles

Headline
HHS announces revised 340B Rebate Model Pilot Program; see AHA’s statement shared with media 
The Department of Health and Human Services today issued a notice announcing a revised 340B Rebate Model Pilot Program, allowing qualifying drug manufacturers…
Headline
CMS issues hospital inpatient payment final rule for FY 2027
The Centers for Medicare & Medicaid Services today issued a final rule that would increase Medicare rates by a net 2.3% in fiscal year 2027, compared with…
Headline
CMS releases 2025 report on program audits, enforcement for Medicare Advantage, Part D 
The Centers for Medicare & Medicaid Services July 27 released its Contract Year 2025 Part C and Part D Program Audit and Enforcement Report, outlining key…
Headline
Court rules that companies may not impose 340B rebate model without HHS approval
The U.S. District Court for the District of Columbia July 21 upheld a lower court’s decision that Section 340B of the Public Health Service Act does not …
Headline
CMS posts updated FAQ on PAMA clinical laboratory private payer data reporting 
The Centers for Medicare & Medicaid Services has released an updated FAQ on Protecting Access to Medicare Act private payer data reporting. The deadline is…
Headline
Draft guidance released for 2028 cycle of Medicare drug price negotiations 
The Centers for Medicare & Medicaid Services July 16 released draft guidance for the 2028 cycle of negotiations under the Medicare Drug Price Negotiation…