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
340B Covered Entities (CEs) are getting a glimpse into what they can expect to be repaid due the fallout from CMS’ unlawful 340B payment reduction that was struck down by the U.S. Supreme Court in June 2022. CMS discussed a...more
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
This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more
8/6/2019
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare Reform ,
MACs ,
Medicare Payment Reform ,
Payment Rates ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Remedies ,
Rulemaking Process ,
Section 340B ,
Underpayment
In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more
8/16/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reimbursements ,
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