K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more
In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
Drug Pricing Initiatives: In advance of the midterm elections in November, discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the...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
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
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
The Centers for Medicare and Medicaid Services (CMS) just released its 2021 Final Rule (Physician Fee Schedule), with telehealth policy changes and a list of new services covered under Medicare. Actions taken by CMS during...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 COVID-19 infection rates continue to rise in areas of the country, telehealth continues to play an important role in the delivery of healthcare, especially to those most vulnerable to the virus. The Public Health...more
On October 2, 2020, Health and Human Services (HHS) Secretary, Alex M. Azar II, announced the renewal of the public health emergency declaration due to the continued consequences of the COVID-19 pandemic. The 90-day renewal...more
As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...more
On September 13, 2020, President Trump issued an Executive Order seeking to establish most favored nation ("MFN") pricing for Medicare drug payments. The Trump Administration's Order, 'Lowering Drug Prices by Putting America...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
On August 3, 2020, President Trump signed Executive Order 13941 (the “Executive Order”) which expands access to certain telehealth services post-pandemic. The Executive Order focuses on telehealth access for individuals...more
On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”). One order – which has received the...more
[co-author: Daniel Weinstein] In response to widespread cash flow issues resulting from the COVID-19 public health emergency, Congress enacted two key pieces of legislation: the CARES Act and the Paycheck Protection...more
As previously reported, the CARES Act impacts long-term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs). In addition to this legislative action, the Centers for Medicare and...more
SUPPLY SHORTAGES - Provides for the National Academies to examine and report on the security of the U.S. medical product supply chain in order to assess U.S. dependence on critical drugs and devices sourced outside of the...more
In this week’s episode, Mary Beth Johnston, Carolyn Merritt and Leah Richardson discuss the ways in which the Centers for Medicare and Medicaid Services’ (CMS) response to the ongoing COVID-19 outbreak is easing certain...more
On March 30, 2020, the Secretary of the United States Department of Health and Human Services (“HHS”) exercised his authority to waive certain Medicare requirements during an emergency and issued blanket waivers of sanctions...more
In response to the growing concerns of the capacity of the health care workforce as a result of the COVID-19 pandemic, on March 24, 2020 the Secretary of Health and Human Services, Alex Azar, issued a letter and associated...more