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Health-Related Social Needs: Three Trends in Leveraging Community Partnerships

Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more

The Future of the 340B Program: 2023 Key Decisions

Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more

340B Hospitals Win in Medicare OPPS Supreme Court Decision

The Supreme Court issued a long-awaited victory to 340B hospitals this week, when it held in American Hospital Association et al. v. Becerra et al. that the Department of Health and Human Services (HHS) had set unlawful...more

New Provider Relief Funding and 60-day Grace Period for Reports on Funding Previously Received

Since Spring 2020, the Department of Health and Human Services (HHS) has distributed more than $150 billion in Provider Relief Funds (PRF) to health care providers that can be used to reimburse their expenses attributable to...more

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more

HHS Extends Timeline for Spending Provider Relief Fund

The U.S. Department of Health and Human Services (HHS) has issued new guidance extending the timeline for health care providers that received more than $10,000 in payments from the Provider Relief Fund (PRF) to expend and...more

Congress Requires New Medicaid Payment Reporting

As part of the omnibus Federal appropriations bill enacted into law on December 27, 2020, Congress established new reporting requirements for states that make Medicaid supplemental payments. The new requirements follow on the...more

Congress Overrides HHS Guidance on Use of Provider Relief Funds

Congress’ recently-passed Federal Appropriations Act includes new provisions modifying the scope of the Provider Relief Fund payments overseen by the U.S. Department of Health and Human Services (HHS), granting providers new...more

New HHS Board Will Hear 340B Drug Pricing Disputes

On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing...more

COVID-19: Provider Relief Fund General Distribution – Phase 3

On October 1, 2020, the Department of Health and Human Services (HHS) announced a new $20 billion Phase 3 of the Provider Relief Fund (PRF) General Distribution. Much like the Phase 2 funding, Phase 3 funding will be made...more

COVID-19: HHS Publishes Long-awaited Reporting Requirements for Provider Relief Fund Recipients

On September 19, 2020, the Department of Health and Human Services (HHS) released guidance establishing the reporting requirements for health care providers that received Provider Relief Fund (PRF) payments. These reporting...more

COVID-19: Take Two (for some) on Additional DHHS Provider Relief Funding

The Department of Health & Human Services (DHHS) announced some Medicare providers who experienced challenges in the Phase 1 general distribution application period will get a second chance to apply for funds. This limited...more

COVID-19: Understanding HHS’s Plans To Disperse Provider Relief Funds Authorized By The CARES Act

On Wednesday April 22, 2020, the U. S. Department of Human Health and Services (HHS) unveiled its plan to disperse an additional $70 billion in COVID-19 funding authorized by the Coronavirus Aid Relief and Economic Security...more

340B Rate Cuts: DC Court Enjoins and Remands CMS’ 2018 and 2019 Reductions for Hospital Outpatients

On May 6, 2019, a federal district court held that the Department of Health and Human Services’ (HHS) 2018 and 2019 rate reductions for 340B Program participants, including safety net On May 6, 2019, a federal district court...more

340B: DC Circuit Affirms Dismissal of Challenge to 2018 Reimbursement Cuts for 340B Hospitals; New Cuts Already Being Proposed by...

On Tuesday, July 17, 2018, the United States Court of Appeals for the District of Columbia ended a challenge brought by hospitals and hospital associations to the nearly 28 percent reimbursement cuts for 340B hospitals under...more

Court Rules Against 340B Hospitals, Allows Medicare Reimbursement Cuts to Go Forward

On Friday, December 29, 2017, the U.S. District Court for the District of Columbia dealt a blow to hospitals participating in the 340B Drug Pricing Program. By participating in the 340B program, eligible public and...more

CMS Finalizes Reimbursement Cuts for 340B Hospitals

In a striking blow to 340B hospitals, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) released a final Medicare Outpatient Prospective Payment System (OPPS) rule adopting its...more

Hawai’i Receives Approval for the First State Innovation (Section 1332) Waiver

The federal Department of Health and Human Services and Department of Treasury (the Departments) agreed that certain small employer health insurance coverage provisions of the Affordable Care Act (ACA) would be waived for the...more

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

HHS Withdraws Proposed 340B Drug Pricing Program "Mega Regs": Further Guidance Forthcoming

The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been...more

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

OIG Publishes Report Identifying Issues With 340B Contract Pharmacy Arrangements

On February 5, 2014, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) published a report (OIG Report) describing the results of a survey it had conducted of the use of contract...more

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