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
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
The Centers for Medicare and Medicaid Services (CMS) issued guidance on March 28, 2020, outlining how Medicare providers and suppliers can access accelerated and advanced Medicare payments to address financial burdens during...more
Both the U.S. Senate and House of Representatives have now passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and the President is expected to sign the bill into law shortly. The CARES Act appropriates...more
3/27/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Federal Funding ,
Health Care Providers ,
Hospitals ,
Medical Research ,
National Institute of Health (NIH) ,
Rural Health Care Providers ,
SAMHSA ,
Substance Abuse
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
On Thursday, March 19, Majority Leader Mitch McConnell introduced the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), which contains provisions to provide emergency assistance for individuals, families and...more
Introduction - On March 14, 2020, the House passed H.R. 6201, known as the Families First Coronavirus Response Act. An issue arose regarding a needed "technical amendment" that required further action by the House. That work...more
On January 30, 2020, CMS issued long-awaited guidance to states regarding the opportunity to access Medicaid funding through block grants or per-capita caps....more
As part of a government spending package enacted in late December, Congress approved government funding through the end of FY20 (September 30, 2020)....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
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
On May 3, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a draft of long-awaited guidance for hospitals on how they can share space, services and staff with other co-located hospitals and health care...more
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
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