Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Biden Administration to End COVID-19 Emergency Declarations May 11

The Biden administration announced plans last week to end the COVID-19 emergency declarations on May 11. The decision applies to both the national emergency and public health emergency (PHE) in response to COVID-19 that have remained in place for over three years since they were first declared. The end of the emergency declarations will result in a restructured federal COVID-19 response that shifts much of the responsibility for vaccine and treatment distribution to the private sector. People without health insurance will be responsible for paying for vaccines, tests, and treatments out-of-pocket, while insured individuals may see the cost of such products increase. Vaccines will remain free for Medicare, Medicaid, and Children’s Health Insurance Program beneficiaries. Other flexibilities and regulatory authorities instituted in response to the COVID-19 PHE would also end, though some measures have already been de-linked from the emergency declaration. The Consolidated Appropriations Act, 2023, for example, extends certain telehealth policies through 2024 and permits states to resume Medicaid redeterminations in April. Other provisions, such as the Medicare coverage requirement waivers (like the three-day hospital stay requirement prior to a skilled nursing facility admission) and permission for patients to get extended supplies of many drugs under the Medicare prescription drug benefit, were not extended in the year-end funding bill. Hospitals will also no longer receive the 20% increased Medicare payment for the treatment of COVID-19 patients. According to a senior administration official, the transition period over the next three months will allow the White House to “begin the process of a smooth operational wind-down of the flexibilities enabled by the COVID-19 emergency declarations.” The announcement was made within a series of White House statements in opposition to several bills passed by the House of Representatives warning that ending the PHE too soon would have “highly significant impacts on our nation’s health system and government operations.” The bills passed the House include:

  • H.R. 497 - Freedom for Health Care Workers Act, to block the federal COVID-19 vaccine mandate for health care workers under the Medicare and Medicaid programs;
  • H.R. 382 - Pandemic is Over Act, to end the COVID-19 PHE;
  • H.R. 139 - SHOW UP Act of 2023, to end COVID-era telework policies for federal workers; and
  • H.J. Res. 7, to terminate the national emergency declared on March 13, 2020.
This week, the House plans to vote on legislation (H.R. 185) that would end the COVID-19 vaccine mandate for international travelers entering the U.S. Proponents of the bill argue that the requirement should be dropped given the ending of the COVID-19 emergency declarations on May 11.

Presidentís FY24 Budget to Be Released March 9

The White House plans to release President Joe Biden’s fiscal year (FY) 2024 budget on Thursday, March 9. According to Brian Deese, National Economic Council Director, and Shalanda Young, Office of Management and Budget Director, the budget will “show how the President plans to invest in America, continue to lower costs for families, protect and strengthen Social Security and Medicare, and reduce the deficit.” They called on Republicans to release their own budget containing proposals for reducing the deficit. Majority Leader Steve Scalise (R-La.) confirmed the House GOP’s plan to release their proposed budget by April. Republicans have stated their intent to balance the federal budget within the next decade.

Wyden Requests Details on IRAís Drug Rebate Provisions

Senate Finance Committee Chair Ron Wyden (D-Ore.) has sent a letter to the Centers for Medicare and Medicaid Services (CMS) requesting information on how the agency plans to collect the Medicare Part B and Part D inflation rebates created as a part of the drug pricing provisions in last year’s Inflation Reduction Act. The law requires manufacturers to pay a rebate to Medicare when they increase their drug prices faster than the rate of inflation, with Medicare penalizing manufacturers for price increases that outpace inflation starting in October 2022 for Part D drugs and in January 2023 for Part B drugs. Wyden asks for an explanation of how rebates will be calculated and a timeline for their implementation.

Senators Criticize Lack of FDA Vaping Regulation Enforcement

Abipartisan group of 13 senators has sent a letter to the U.S. Department of Health and Human Services criticizing the “repeated failures” of the Food and Drug Administration (FDA) to regulate the tobacco and e-cigarette market and to take action against companies marketing illegal vaping products. The agency recently estimated that it will not finish reviewing marketing applications from e-cigarette manufacturers until the end of December, six months later than previously projected. The FDA already stands 16 months past a court-ordered deadline to complete review of e-cigarette marketing applications. The lawmakers argue that as many as one million children will be at risk of starting e-cigarette use because of this delay. Their letter follows a report from the Reagan-Udall Foundation which found that the absence of “timely enforcement action jeopardizes public health and undermines creditability and effectiveness in tobacco product regulation.”

Legislators Urge Elevation of ONDCP

Abipartisan, bicameral group of 55 legislators is urging President Joe Biden to reinstate the Director of the Office of National Drug Control Policy (ONDCP) to a cabinet-level position amid rising rates of drug overdoses across the United States. They request that the President announce the change during this week’s State of the Union address, arguing that re-elevating “ONDCP to the Cabinet will allow it to marshal the full resources of the federal government against this scourge of overdoses and demonstrate to the Congress and the American people [his] commitment to ending it.” Overdoses currently represent the leading cause of death for Americans aged 18 to 45.

Lawmakers Request More Funding for KidneyX

Abipartisan, bicameral group of lawmakers is asking the Biden administration to increase funding for kidney care in the President’s fiscal year 2024 budget. The lawmakers request a $25 million investment in KidneyX – a partnership between the U.S. Department of Health and Human Services and the American Society of Nephrology that aims to encourage innovation in the prevention, diagnosis, and treatment of kidney diseases. “With more funding, KidneyX could expand the number of innovators it supports and accelerate the development of transformative technologies, particularly the artificial kidney,” the letter states. The lawmakers argue this investment could ultimately reduce the amount of money the nation spends on kidney care and the treatment of kidney failure. The letter was signed by Sens. Ben Cardin (D-Md.) and Todd Young (R-Ind.), and Reps. Suzan DelBene (D-Wash.) and Larry Bucshon (R-Ind.).

Democrats Ask Manufacturer to Revise Mifepristone Label

Agroup of Senate Democrats led by Sens. Mazie K. Hirono (D-Hawaii), Maggie Hassan (D-N.H.), and Elizabeth Warren (D-Mass.) is urging Danco Laboratories to add a miscarriage management indication to the drug label for Mifeprex (mifepristone). The lawmakers argue that because miscarriage is not currently included on the approved label, health care providers lack clear legal guidance on the product’s use and “patients experiencing early pregnancy loss who need mifepristone cannot easily access this critical treatment, placing them at risk of serious injury and death.” The Food and Drug Administration recently rejected a citizen petition filed by the American College of Obstetricians and Gynecologists, along with 48 other organizations, for such a label change on the grounds that only the manufacturer of the drug has the authority to request this type of change.

GAO Releases Report on Nationís Ability to Investigate Pandemic Origins

The Government Accountability Office (GAO) released a new report last week examining the United States’ lack of a national strategy for investigating the origins of disease outbreaks and pandemics. The report details the technologies available for researchers to investigate a pandemic’s origin – such as genomic sequencing, bioinformatics analysis, genetic databases, serology, and epidemiological surveillance – and their limitations. Experts told the GAO, however, that such technologies are not the limiting factor for determining the likely origin of a pandemic. The agency identified three cross- cutting challenges facing disease origin investigations: a lack of sufficient access to samples and genetic sequence data; a lack of standardized processes for submitting, accessing, and using genetic sequence data; and a lack of a sufficient and skilled interdisciplinary workforce. The report also outlines five policy options to address these challenges:

  1. Establish multilateral agreements for accessing and sharing samples and genetic sequence data;
  2. Develop standardized processes for genetic sequence database use;
  3. Improve current, or develop new, genetic sequence database tools;
  4. Encourage the development, retention, and growth of a workforce with the critical skills needed for pandemic origin investigations; and
  5. Augment or develop a national strategy to better coordinate and collaborate domestically and internationally on pandemic origin investigations.
A GAO representative testified before the House Energy and Commerce Oversight and Investigations Subcommittee during the panel’s first hearing of the 118th Congress, titled “Challenges and Opportunities to Investigating the Origins of Pandemics and Other Biological Events” last week. Republican leadership of the full committee have also revived their investigative work into the origins of COVID-19, sending letters to the National Institutes of Health and EcoHealth Alliance requesting documents related to research done at the Wuhan Institute of Virology.

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