K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On Tuesday, April 29, the Supreme Court of the United States issued one decision: Advocate Christ Medical Center v. Kennedy, No. 23-715: This case addresses the proper method for calculating the “disproportionate share...more
On January 25, 2022, the U.S. Court of Appeals for the Second Circuit issued an important opinion in Barrows v. Becerra that will have a significant impact on hospitals, skilled nursing facilities and, potentially, other...more
On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers...more
The Centers for Medicare and Medicaid Services (CMS) has proposed increasing the penalty for violations of the hospital price transparency rule in the proposed outpatient pay rule announced on July 19, 2021. Hospitals...more
Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more
By letter dated April 13, 2021 (Letter), the Democrat and Republican leadership of the House Committee on Energy and Commerce and its Subcommittee on Health, wrote United States Health and Human Services Secretary, Xavier...more
On December 29, 2020, the United States Court of Appeals for the District of Columbia issued its opinion in American Hospital Association v. Azar (the Opinion) upholding the Hospital Transparency Regulation (the Rule) issued...more
On December 29, 2020, the U.S. Court of Appeals for the District of Columbia Circuit upheld a CMS final rule promulgated in November 2019 that requires hospitals to disclose various forms of pricing information related to the...more
On November 13, 2020, the D.C. Court of Appeals upheld a key ruling regarding disproportionate share hospital (“DSH”) payments, in Bethesda Health Inc. v. Azar, a significant victory for hospitals. Hospitals that treat a...more
As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more
The U.S. Department of Health and Human Services (HHS) recently issued new guidance regarding reporting and auditing requirements that may impact providers and suppliers who retain payments received from the Public Health and...more
On June 23, the U.S. District Court for the District of Columbia dismissed a challenge to a federal rule requiring hospitals to disclose prices they privately negotiated with insurers....more
The United States Attorney for the District of Massachusetts is proactively seeking to find, investigate, and prosecute unlawful attempts to exploit the COVID-19 pandemic and is asking hospitals to assist. U.S. Attorney...more
Effective March 15, 2020, certain hospitals that fail to comply with specific HIPAA Privacy Rule requirements will not be subject to HIPAA sanctions and penalties, according to a “COVID-19 & HIPAA Bulletin” issued by U.S....more
On September 17, 2019, the US District Court for the District of Columbia ruled in American Hospital Association, et al. v. Alex Azar, II, et al that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory...more
The Issue: On June 24, 2019, President Trump signed an executive order, which instructed the Department of Health and Human Services to publish rules requiring hospitals to publicly disclose their negotiated rates for...more
In a long-awaited ruling, on May 6, 2019, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia declined to vacate the Secretary’s CYs 2018 and 2019 Outpatient Prospective Payment System (OPPS)...more
On December 27, 2018, the U.S. District Court for the District of Columbia issued a permanent injunction to the Department of Health and Human Services (HHS) to stop a major reduction in Medicare reimbursement to hospitals...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more
This episode outlines the basics of the 340B Drug Pricing Program and discusses potential changes affecting the program, including CMS’s recent proposal to cut reimbursement for Part B drugs purchased under the 340B program....more
On July 25, 2017, the United States Court of Appeals for the District of Columbia Circuit held that HHS violated the terms of the Medicare statute by failing to undertake notice-and-comment rulemaking in implementing its...more
On March 10, 2017, Judge John Bates of the U.S. District Court for the District of Columbia upheld CMS’s three-year cost report reopening limitation, as applied to “predicate fact” determinations. The regulation at issue is...more
The 21st Century Cures Act (Cures) was signed into law December 13, 2016. While the primary focus of the 996-page Act centered on biomedical innovation, several components of Cures have significant implications for health...more
Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more
On October 27, 2016, a three-judge panel for the United States Court of Appeals for the First Circuit issued an opinion concluding that a Medicare fiscal intermediary (Intermediary) does not have the authority to enter into a...more