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
On Friday, July 15th, CMS published its CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule) and gave 340B covered entities a glimpse into how the agency intends to react to...more
7/19/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Authority ,
Remedies ,
Section 340B
The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like...more
2/22/2022
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inpatient Prospective Payment System (IPPS) ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
Medicare Advantage ,
Outpatient Prospective Payment System (OPPS) ,
Payor Contracts ,
Physician Fee Schedule ,
Section 340B ,
Surprise Medical Bills ,
Telehealth
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
Without fanfare or any significant discussion, the Bipartisan Budget Act (Act) contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many...more
11/2/2015
/ Bipartisan Agreement ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Medicare ,
MedPAC ,
Obama Administration ,
OIG ,
OPPS ,
Pending Legislation ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
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 House Energy & Commerce Health Subcommittee on Health hearing entitled, “Examining the 340B Drug Pricing Program”, originally scheduled for Thursday, March 5th has been RESCHEDULED for March 24, 2015 at 10:00 a.m. EST. ...more
Thursday, March 5th at 10:00 a.m. EST, the House Energy & Commerce Health Subcommittee on Health will hold a hearing entitled, “Examining the 340B Drug Pricing Program.” The purpose of the hearing is to review the...more