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 November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more
12/3/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Manufacturers ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors
On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period (IFC) to implement a payment model that will significantly reduce Medicare reimbursement rates for...more
12/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Interim Final Rules (IFR) ,
Manufacturers ,
Medicare ,
Payment Methods ,
Prescription Drugs ,
Reimbursements
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 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
Both Congress and the White House continue to push for bipartisan action to address high drug prices, with hopes of enacting legislation as part of a spending package that must pass by May 22, 2020....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
Both the House and Senate are expected to consider legislation to address high drug prices when Congress returns. Meanwhile, the Administration has faced roadblocks to several of its high-profile proposals to address drug...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
Health care issues will remain a central focus in Washington throughout 2019. Having gained control of the House following the 2018 mid-term elections, Democrats now have the ability to block President Trump's legislative...more
2/12/2019
/ Affordable Care Act ,
Block Grants ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Congressional Oversight ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid Expansion ,
Medicare ,
Medicare for All ,
Political Parties ,
Popular ,
Prescription Drugs ,
Repeal ,
Stark Law ,
State Medicaid Programs ,
Trump Administration ,
Waivers
On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more
2/5/2019
/ Anti-Kickback Statute ,
Arm's Length Principle ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fair Market Value ,
Managed Care Contracts ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare Part D ,
OIG ,
Pharmaceutical Benefits Scheme ,
Prescription Drugs ,
Price Reduction Clause ,
Proposed Regulation ,
Public Comment ,
Rebates ,
Safe Harbors
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
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