On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers....more
4/22/2024
/ Claim Procedures ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Healthcare ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Recently, HRSA verbally confirmed that it has assigned Administrative Dispute Resolution (ADR) panelists, a key development to move a handful of pending ADR complaints forward. Those complaints contain allegations that drug...more
There are initial indications that the Health Resources and Services Administration (HRSA), which administers the federal 340B drug pricing program, may allow hospitals to begin using 340B drugs at offsite locations (“Child...more
In this issue, Polsinelli’s 340B and Reimbursement teams provide an update on the most recent developments in the ongoing 340B /Part B Payment litigation and also highlight recent Government Accountability Office (“GAO”)...more
5/16/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
GAO ,
Health Care Providers ,
HRSA ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Provider Payments ,
Section 340B
The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more
1/25/2017
/ Affordable Care Act ,
Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Freeze ,
Section 340B ,
Trump Administration
On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more
8/30/2016
/ Arbitration ,
Comment Period ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Healthcare ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more
10/20/2015
/ Biopharmaceutical ,
Covered Entities ,
GPOs ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Rural Health Care Providers ,
Section 340B ,
Summary Judgment
As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more
9/17/2015
/ AIDS ,
Covered Entities ,
Fee-for-Service ,
GPOs ,
Healthcare ,
HRSA ,
Managed Care Contracts ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
The Health Resources and Services Administration (“HRSA”) released an advanced copy of its long-awaited proposed 340B Omnibus Guidance (“Guidance”) today. The document can be found here. Polsinelli is currently reviewing the...more
Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more
The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more
On Thursday, HRSA formally withdrew its much-anticipated 340B Mega-Reg from the rulemaking process, effectively abandoning its effort to overhaul existing 340B program guidance through new regulations. Commander Krista...more