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
It has certainly been a year of ups and downs for 340B hospitals. While litigation continues in the manufacturer 340B price restriction space, and 340B hospitals continue to experience financial, legal and operational...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
Wednesday, the United States Supreme Court handed down a highly anticipated, unanimous opinion, AHA v. Becerra, confirming that CMS exceeded its statutory authority when it implemented a discriminatory reimbursement structure...more
6/17/2022
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Lack of Authority ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
SCOTUS ,
Section 340B ,
Statutory Authority
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
On Monday, July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule). While the Proposed Rule...more
7/22/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drug Coverage ,
Prescription Drugs ,
Reimbursements ,
Section 340B
On November 27, 2020, CMS published its Most Favored Nation (MFN) Model Interim Final Rule (IFR) that seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive...more
12/10/2020
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Cross-Border Transactions ,
Drug Pricing ,
Interim Final Rules (IFR) ,
Medicare Part B ,
Most-Favored Nations ,
Prescription Drugs ,
Section 340B ,
Trump Administration
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
Late last week, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment System (“OPPS”) final rule [CMS-1717-FC]. While many hospitals had hoped for relief from recent...more
11/6/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Coding ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicaid Reform ,
Medicare ,
Medicare Payment Reform ,
Off-Campus Departments ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Services ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Recovery Audit Contractors (RACs) ,
Rulemaking Process ,
Section 340B
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 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
A federal district court granted a permanent injunction against the Medicare Part B 2018 Outpatient Prospective Payment System (“OPPS”) payment cuts for separately payable, non-pass through drugs purchased through the 340B...more
1/7/2019
/ Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Low-Income Issues ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Permanent Injunctions ,
Prescription Drugs ,
Section 340B
Significant Medicare Part B reimbursement rate cuts and burdensome claim modifiers apply to certain drugs purchased by hospitals through the 340B drug discount program effective on Jan. 1, 2018 after a federal judge declined...more
In its 2018 Outpatient Prospective Payment System final rule (Final Rule) issued Nov. 1, Centers for Medicare and Medicaid Services (CMS) implemented a significant Medicare Part B payment reduction for separately payable,...more
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
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
On Wednesday, May 6, the Health Resources and Services Administration, Office of Pharmacy Affairs (“OPA”) forwarded a draft copy of its 340B Program Omnibus Guidelines (“Guidelines”) to the Office of Management and Budget for...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
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