House Appropriators to Mark Up FDA Bill This Week

The House Appropriations Subcommittee on Agriculture, Food and Drug Administration (FDA), and Related Agencies marked up its draft fiscal year 2023 spending bill last week. The legislation totals $27.2 billion, an 8% increase over the previous year. It includes $3.65 billion in discretionary funding for the FDA, a $341 million increase and slightly higher than the President’s budget request. Appropriations Chair Rosa DeLauro (D-Conn.) stated the extra funds would support the inspection of baby formula and review of new products. The bill was advanced by voice vote, despite GOP opposition to the increases in FDA food safety funding. The full Appropriations Committee is scheduled to meet on Thursday to markup the legislation, which lawmakers hope to bring to the floor of the full House next month.

Senate Finance Leadership Release Youth Mental Health Discussion Draf

Bipartisan leadership of the Senate Finance Committee released a draft bill to overhaul the youth mental health care system as a part of an expansive mental health care package. The discussion draft would expand mental health programs in schools and proposes to allow health care providers to receive Medicaid payments for the delivery of behavioral and physician health care services on the same day. The proposal, drafted by Chair Ron Wyden (D-Ore.), Ranking Member Mike Crapo (R-Idaho), Sen. Tom Carper (D-Del.), and Sen. Bill Cassidy (R-La.), would compel states to clarify Medicaid guidance on allowable payments, improve screening and diagnostic benefits, and require Medicaid to issue guidance on care for foster youth with mental health care needs.

MedPAC June 2022 Report to the Congress

The Medicare Payment Advisory Commission (MedPAC) released its June 2022 Report to Congress last week. The report asserts that the Medicare program would have spent $6.6 billion less in 2019, and beneficiaries would have saved $1.7 billion in out-of-pocket costs, if payment rates between hospital outpatient departments, ambulatory surgical centers, and doctors’ offices were aligned. The report also recommends that the Centers for Medicare and Medicaid Services (CMS) consider using a population-based payment approach that reduces the number of accountable care organization model tracks, transitioning to periodic administrative updates of benchmarks using a growth factor, and using a mandatory national episode-based payment model for certain clinical episodes to reduce the number of Medicare alternative payment models. In response to the rising launch prices of certain drugs approved with limited clinical evidence, MedPAC recommends that Congress give the U.S. Department of Health and Human Services (HHS) Secretary the discretion to use coverage with evidence development and to cap a drug’s price based on existing evidence. The report also recommends that the HHS Secretary be granted the authority to use internal reference pricing to establish a maximum reimbursement level for a group of drugs. Other topics covered in the report include vulnerable Medicare beneficiaries’ access to care; a framework for identifying safety net providers and whether new funding may be warranted; and options to improve the accuracy of Medicare Advantage payments.

WH to Release New Pandemic Preparedness Plan

The Biden administration is getting ready to release a new plan to prepare for future pandemics and other biological threats, according to a senior administration official. The plan to improve the nation’s framework for preparedness, response, and recovery is the result of more than a year of work by national security and public health officials. The administration could release the National Biodefense Strategy as soon as this month. It will outline an approach for countering biological threats to humans, animals, environments, and crops. The Strategy aims to more clearly delineate the responsibilities of federal agencies in pandemic response. The first iteration of the National Biodefense Strategy was released in September 2018 by the Trump administration.

Becerra, Fauci Test Positive in Breakthrough COVID Cases

U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra tested positive for COVID-19 last week after taking an antigen test. He is fully vaccinated and boosted against COVID-19 and was experiencing mild symptoms. He previously tested positive for COVID-19 last month. He was not considered a close contact of President Joe Biden or Vice President Kamala Harris and planned to work in isolation in accordance with the Centers for Disease Control and Prevention guidance. This is the second time in about a month that the HHS Secretary has tested positive for COVID-19.

President Joe Biden’s Chief Medical Officer and Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci has also tested positive for COVID-19. He is fully vaccinated and has been boosted twice and was experiencing mild symptoms of the virus. Fauci planned to isolate and work from his home and was not considered a close contact for President Biden or other senior government officials.

COVID Vaccines Authorized for Nationís Youngest Children

The U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 vaccine and the PfizerBioNTech COVID-19 vaccine for the prevention of COVID-19 to include use in children down to 6 months of age last week. The emergency use authorization was followed by the Centers for Disease Control and Prevention’s endorsement of a unanimous recommendation from the Advisory Committee on Immunization Practices (ACIP) to vaccinate all children as young as 6 months old with one of the two vaccines. The two vaccines for this population use different dosages, a different number of shots, and different intervals between shots. While severe disease and death from COVID-19 remain uncommon in children compared to adults, COVID-19 is still a leading cause of death among children and adolescents, including children aged one to four.

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