WynneSights Blog

Commentary, news, and updates from the Wynne Health Group.


To Extend or Not Extend? Biden Administration Prepares States for Decision on PHE

By Lauren Testa | May 12, 2022

The current COVID-19 public health emergency (PHE) declaration ends on July 15. Notification of the PHE’s end is anticipated by Monday, May 16, given the Biden administration’s promise to provide states with a 60-day warning to support a smooth post-PHE transition. There has been some discussion about continuing the PHE another 90 days given the…

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E&C FDA User Fee Reauthorization Package Addresses the Accelerated Approval Pathway, Clinical Trial Diversity, and Generic Market Entry

By Erin Slifer | May 5, 2022

Yesterday, the House Energy and Commerce (E&C) Committee released the legislative text for the reauthorization of the Food and Drug Administration (FDA) user fee agreements, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA) (press…

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Senate HELP Hearing on FDA User Fees: Advancing Medical Product Regulation and Innovation for Benefits and Patients

By Erin Slifer | April 27, 2022

On April 26, 2022, the Senate Committee on Health, Education, Labor, and Pensions (HELP) convened a hearing with the directors of the Food and Drug Administration (FDA) to discuss the reauthorization of the FDA user fee amendment programs. Directors from the FDA Centers discussed how the Prescription Drug User Fee Amendments (PDUFA), the Biosimilar User…

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State of the Union Addresses Drug Pricing, COVID-19, Mental Health, and More

By Erin Slifer | March 3, 2022

President Biden addressed Congress in his first State of the Union address. While most of his remarks were focused on the evolving situation in Ukraine and the economy, the President addressed several health care priorities including lingering provisions from the Build Back Better Act (BBBA), COVID-19, and mental health, among other topics. Additional details on health care priorities follow.…

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What’s Ahead for Rulemaking: Medicare Edition

By Josh LaRosa | February 22, 2022

With Congress in recess this week, we look ahead to what is underway on the administrative front with respect to Medicare – including changes to electronic prior authorization, Medicare payment updates, Medicare Advantage (MA) and Part D Advance Notice, and modifications to Medicare enrollment. A lookahead for key Medicaid-focused changes is available here. March 23…

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What’s Ahead for Rulemaking: Medicaid Edition

By Alyssa Llamas | February 22, 2022

The Centers for Medicare and Medicaid Services (CMS) is preparing for the unwinding of the COVID-19 public health emergency (PHE) when states will resume Medicaid eligibility redeterminations. The PHE is currently set to expire on April 16. However, we anticipate HHS Secretary Xavier Becerra will renew the PHE another 90 days through July 16, since…

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E&C Health Members Discuss Aduhelm, Pandemics, Rare Diseases in FDA User Fee Reauthorization Hearing

By Billy Wynne | February 7, 2022

On Feb. 3, 2022, the Subcommittee on Health of the House Committee on Energy & Commerce (E&C) convened a hearing on the reauthorization of three Food and Drug Administration (FDA) user fee programs (hearing memo). These include the seventh reauthorization of the Prescription Drug User Fee Act (PDUFA VII), the third reauthorization of the Generic…

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U.S. Capitol

Key Takeaways from Senate HELP Hearing on Mental Health and SUD; Top Legislative Priorities for Bipartisan Package

By Alyssa Llamas | February 7, 2022

On Feb. 1, 2022, the Senate Committee on Health, Education, Labor and Pensions (HELP) Committee convened a hearing to discuss priorities and proposals for bipartisan legislation addressing mental health and substance use disorders (SUD). The discussion signaled that the legislation could be comparable to the SUPPORT for Patients and Communities Act (P.L. 115-271) in terms…

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President Biden’s American Families Plan; Addresses Child Care, Paid Leave, Nutrition, Education; Makes Permanent ACA Premium Tax Credit Increase; No Drug Pricing

By Alyssa Llamas | April 28, 2021

In advance of President Joe Biden’s address to a Joint Session of Congress this evening, the White House unveiled the American Families Plan, the “human infrastructure” component of the Administration’s broader infrastructure plan (fact sheet). The roughly $1.8 trillion proposal calls for investments in child care, paid leave, nutrition, and education as well as various…

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Multi-Stakeholder Taskforce Offers Long-Term Recommendations on Telehealth

By Josh LaRosa | September 17, 2020

On September 15, 2020, the Taskforce on Telehealth Policy (TTP) – convened by the National Committee for Quality Assurance, Alliance for Connected Care, and American Telemedicine Association – convened a public briefing on its findings and recommendations regarding the COVID-19 telehealth flexibility expansions (full report). First announced in June 2020 (details), the TTP was convened…

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