On May 17, 2021, the Health Resources and Services Administration (HRSA) sent letters to six drug manufacturers notifying them that their actions placing restrictions on access to 340B-discounted drug prices by health care...more
On December 14, 2020, the Health Resources and Services Administration (HRSA) published in the Federal Register a final regulation to implement a 340B drug pricing program administrative dispute resolution (ADR) process. The...more
Members of Congress of both parties are requesting that the Department of Health and Human Services (HHS) take action to ensure that providers participating in the 340B drug pricing program can continue to receive discounted...more
On July 31, 2020, the D.C. Circuit Court of Appeals issued a decision reversing a lower court decision and upholding Medicare payment cuts to certain hospitals participating in the 340B drug pricing program that have been in...more
8/20/2020
/ Administrative Authority ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Hospitals ,
Medicare Part B ,
Medicare Payment Reform ,
Outpatient Prospective Payment System (OPPS) ,
Payment Rates ,
Reversal ,
Section 340B
On August 4, 2020, CMS issued a proposed rule to further reduce outpatient drug payment rates under Medicare to certain hospitals participating in the 340B drug pricing program. As part of the 2021 OPPS Proposed Rule, CMS...more
The Health Resources and Services Administration (HRSA) has issued guidance eliminating a longstanding enforcement position that delayed the ability of hospitals participating in the 340B drug pricing program to use...more
The Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) has created a COVID-19 Resources page on its website providing information for 340B drug pricing program stakeholders. In particular,...more
3/25/2020
/ Audits ,
Coronavirus/COVID-19 ,
Covered Entities ,
Group Purchasing Organizations (GPO) ,
Health Care Providers ,
HRSA ,
New Guidance ,
Prescription Drug Coverage ,
Prescription Drugs ,
Public Health Emergency ,
Section 340B ,
Telehealth ,
Telemedicine
Conversations also continue regarding the 340B drug pricing program, which requires drug manufacturers to sell outpatient drugs at discounted prices to safety net providers, including certain public and private non-profit...more
Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more
1/30/2020
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Discounts ,
Drug Pricing ,
GAO ,
Health Care Providers ,
Hospitals ,
HRSA ,
Information Reports ,
Medicaid ,
Medicare ,
Medicare Part B ,
MedPAC ,
New Guidance ,
Non-Profit Hospitals ,
Pay Reductions ,
Prescription Drugs ,
Provider Payments ,
Regulatory Agenda ,
Regulatory Oversight ,
Section 340B ,
State and Local Government
The D.C. Circuit Court of Appeals has scheduled oral arguments for November 8, 2019 in the ongoing lawsuit challenging Medicare payment cuts to hospitals in the 340B drug pricing program. The court is considering an appeal by...more
A federal district court has ruled, for a second time, in favor of hospitals challenging the legality of Medicare payment cuts targeting certain hospitals in the 340B drug pricing program. In a May 6, 2019 decision, the U.S....more
6/5/2019
/ Appeals ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Hospitals ,
Injunctive Relief ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pay Reductions ,
Payment Rates ,
Prescription Drugs ,
Provider Payments ,
Remand ,
Remedies ,
Section 340B ,
Stays ,
Unlawful Policies
The U.S. government has appealed a federal district court decision issued in December 2018 that found the Department of Health & Human Services (HHS) exceeded its authority by reducing Part B drug reimbursement to certain...more
3/19/2019
/ Abeyance ,
Appeals ,
Arbitrary and Capricious ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Hospitals ,
Lack of Authority ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drug Coverage ,
Prescription Drugs ,
Remedies ,
Section 340B
In an opinion issued December 27, 2018, a Federal District Court ruled that the Department of Health & Human Services (HHS) exceeded its authority by reducing Part B drug reimbursement to certain hospitals in the 340B drug...more
1/11/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Drug Pricing ,
DSH ,
Government Shutdown ,
Hospitals ,
Lack of Authority ,
Medicare ,
Motion To Stay ,
Outpatient Prospective Payment System (OPPS) ,
Permanent Injunctions ,
Remedies ,
Ripeness ,
Rural Health Care Providers ,
Section 340B ,
Subsequent Litigation ,
Trial Court Orders
Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more
12/13/2018
/ Affordable Care Act ,
Civil Monetary Penalty ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
Health Care Providers ,
Hospitals ,
HRSA ,
Manufacturer Liability ,
Office of Pharmacy Affairs Information System (OPAIS) ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more
10/25/2018
/ Audits ,
Corrective Actions ,
Covered Entities ,
Drug Pricing ,
Eligibility ,
Guidance Update ,
Health Care Providers ,
HRSA ,
Manufacturers ,
Pharmacies ,
Prescription Drugs ,
Provider Payments ,
Registration Requirement ,
Section 340B ,
Self-Disclosure Requirements
As the Trump Administration moves forward with proposed policy changes to address high drug prices, a common theme is emerging: a number of the proposals have the potential to reduce Medicare reimbursement to hospitals and...more
8/10/2018
/ Add-ons ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Health Care Programs (FHCP) ,
Health Care Providers ,
Hospitals ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
Outpatient Prospective Payment System (OPPS) ,
Pay Reductions ,
Physician Fee Schedule ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Provider Payments ,
Request For Information ,
Section 340B ,
Trump Administration
On July 31, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule outlining the proposed payment rates for 2019 under the Medicare Outpatient Prospective Payment System (OPPS), one of several payment...more
The Medicare program is once again looking to reduce payments to 340B hospitals for Part B drugs and biologicals. As part of its proposed payment regulation for hospitals under the Outpatient Prospective Payment System (OPPS)...more
8/7/2018
/ Biologics ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Dismissals ,
Disproportionate Share Adjustments ,
Hospitals ,
Injunctive Relief ,
Medicare ,
Medicare Part B ,
Off-Campus Departments ,
Outpatient Prospective Payment System (OPPS) ,
Pay Reductions ,
Prescription Drug Coverage ,
Provider Payments ,
Ripeness ,
Rural Health Care Providers ,
Section 340B ,
Trump Administration
The Government Accountability Office (GAO) issued a report on June 28, 2018 regarding federal oversight of compliance at 340B program contract pharmacies. The 340B drug pricing program requires drug manufacturers to sell...more
On Friday, May 11, President Donald Trump and Department of Health and Human Services (HHS) Secretary Alex Azar presented the Administration's long-awaited plan to address drug pricing. The proposed framework, entitled,...more
The Department of Health and Human Services (HHS) is soliciting comments from the public on the Administration's proposals to reduce drug prices and is targeting the 340B drug pricing program as an area of focus. ...more
On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more
4/12/2018
/ Appeals ,
Bipartisan Agreement ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Dismissals ,
Disproportionate Share Adjustments ,
Exemptions ,
Hospitals ,
Medicare ,
Medicare Advantage ,
Medicare Part B ,
New Guidance ,
Out of Network Provider ,
Outpatient Prospective Payment System (OPPS) ,
Pay Reductions ,
Preliminary Injunctions ,
Prescription Drugs ,
Proposed Legislation ,
Reversal ,
Ripeness ,
Rural Health Care Providers ,
Section 340B ,
Statutory Authority