On May 2, 2022, news outlet Politico published a draft of the Supreme Court’s upcoming decision in Dobbs v. Jackson Women’s Health Organization, a case challenging Mississippi’s ban on abortion after 15 weeks. The central argument of the case rests on the constitutionality of abortion, creating an opportunity to reassess the landmark 1973 Roe v.…

On May 17, 2022, the U.S. district court for the District of Columbia granted the Pharmaceutical Research and Manufacturers of America (PhRMA)’s motion for summary judgement and thereby vacated the patient assistance penalty provision in the accumulator adjustment rule of 2020 (WHG summary of the rule here). The issue in contention was the finalized provision…

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…

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…

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…

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.…

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…

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…

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…

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…