On September 30, 2021, the Departments of Health and Human Services (HHS), Labor, and Treasury (the Departments), along with the Office of Personnel Management (OPM), released an interim final rule with comment period (IFC)...more
On July 1, 2021, the Departments of Health and Human Services (HHS), Labor, and Treasury (the Departments), along with the Office of Personnel Management (OPM), released an interim final rule with comment period (IFC)...more
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 Friday, June 11, 2021, the Department of Health and Human Services (HHS) announced the deadlines by when health care providers must use COVID-19 Provider Relief Fund (PRF) payments and submit reports to HHS on use of...more
As part of the FY 2022 Inpatient Prospective Payment System (IPPS) proposed rule issued on April 27, 2021, CMS intends to repeal a requirement that hospitals report their median payer-specific negotiated charges with Medicare...more
On April 13, 2021, four key lawmakers in the U.S. House of Representatives wrote to the U.S. Department of Health and Human Services (HHS) expressing concern over reports of non-compliance with hospital price transparency...more
On March 11, 2021, President Biden signed into law the American Rescue Plan Act, a $1.9 trillion package to provide relief related to the COVID-19 public health emergency. The final legislation, which passed with support from...more
3/22/2021
/ American Rescue Plan Act of 2021 ,
Biden Administration ,
CARES Act ,
Children's Health Insurance Program (CHIP) ,
COBRA ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Grants ,
Health Care Providers ,
Health Insurance ,
Medicaid ,
Medicare ,
Mental Health ,
Public Health ,
Relief Measures ,
Rural Health Care Providers ,
Skilled Nursing Facility ,
Vaccinations
On December 21, 2020, the House and Senate passed fiscal year (FY) 2021 federal omnibus appropriations legislation that included the fifth measure passed by Congress to address the COVID-19 pandemic. In addition to providing...more
12/28/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Funding ,
Financial Stimulus ,
Health Care Providers ,
Healthcare Facilities ,
Medicaid ,
Medicare ,
Popular ,
Relief Measures
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 September 19, 2020, the Department of Health and Human Services (HHS) released detailed guidance outlining reporting requirements for health care providers that receive payments from the COVID-19 Provider Relief Fund...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 June 9, 2020, the Department of Health and Human Services (HHS) announced additional payments under the COVID-19 Provider Relief Fund to reimburse providers for health care related expenses and revenue losses attributable...more
On May 1, 2020, the Department of Health and Human Services (HHS) announced additional payments under the COVID-19 Provider Relief Fund to reimburse providers for health care related expenses and revenue losses attributable...more
5/15/2020
/ Attestation Requirements ,
CARES Act ,
Compliance ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Eligibility ,
Funding Portal ,
Guidance Update ,
Health Care Providers ,
Hospitals ,
Long Term Care Facilities ,
MACPAC ,
Overpayment ,
Provider Relief Fund ,
Reporting Requirements ,
Rural Health Care Providers
On April 23, 2020, the House of Representatives passed the Paycheck Protection Program and Health Care Enhancement Act, which previously passed the Senate on April 21, 2020, and is expected to be signed into law by the...more
4/26/2020
/ Biomedical Advanced Research and Development Authority (BARDA) ,
Centers for Disease Control and Prevention (CDC) ,
Community Health Systems ,
Coronavirus/COVID-19 ,
Dentists ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Health Care Providers ,
Indian Health Service (IHS) ,
Manufacturers ,
Medical Research ,
National Institute of Health (NIH) ,
Paycheck Protection Program (PPP) ,
Paycheck Protection Program and Health Care Enhancement Act ,
Popular ,
Relief Measures ,
Rural Health Care Providers ,
Skilled Nursing Facility ,
Small Business Loans ,
Uninsured Patients ,
Virus Testing
Health care providers are beginning to receive payments from the Department of Health and Human Services (HHS) to address expenses and revenue losses related to coronavirus (COVID-19). On April 10, 2020, HHS announced the...more
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
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
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