June 27, 2022

Volume XII, Number 178

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June 27, 2022

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McDermottPlus Check-Up: February 18, 2022

THIS WEEK’S DOSE

The Senate passed a short-term continuing resolution (CR) this week, preventing a government shutdown and extending federal funding through March 11. The chamber also confirmed Robert Califf to be the next Food and Drug Administration (FDA) Commissioner.

CONGRESS

Senate Passes Short-Term CR. On February 17, the Senate approved (65-27) a continuing resolution (CR) to provide short-term funding to federal programs through March 11. The CR passed the House of Representatives on February 7, and now heads to President Biden for his signature. The Senate also voted on three amendments, which all failed: (1) Amendment #4929 offered by Senator Lee which aimed to defund all federal COVID-19 vaccine mandates (vote 46-47); (2) Amendment #4927 offered by Senator Cruz on stopping federal funding to schools and child care centers that require COVID-19 vaccines (44-49); and (3) Amendment #4930 offered by Senator Braun requiring a balanced federal budget (47-45), which would have required 60 affirmative votes to pass.

The stopgap funding bill will avoid a government shutdown when the current continuing resolution expires today, February 18. Appropriators will now have three more weeks to reach a bipartisan agreement on fiscal year 2022 spending bills. Republicans and Democrats are close to reaching a bipartisan agreement and remain optimistic that they will produce a comprehensive funding measure by the deadline.

Conversations around additional COVID-19 relief are ongoing. This week, the Department of Health and Human Services (HHS) gave Congress a $30 billion funding request focused mostly on testing and vaccine procurement and development.

This request included:

  • $17.9 billion – Procurement of oral antivirals, monoclonal antibodies, and vaccines

  • $4.9 billion – Sustaining test capacity, continuation of community testing sites, continuation of accelerated development of at-home tests

  • $3 billion – Continuation of the uninsured fund

  • $3.7 billion – Development of vaccines that protect against future variants

  • $0.5 billion – CDC surveillance and operations around the detection of emerging variants and other infectious disease threats

The Administration request did not include funding for international vaccine distribution or broader potential Administration needs beyond HHS. Nor did it include any additional direct support for healthcare providers despite urgent pleas from hospitals and other healthcare providers for more support for the Provider Relief Fund. Members of Congress from both parties have questioned whether HHS needs additional funding on top of previously allocated dollars, leaving questions as to whether Congress will provide additional COVID funding.

Senate Confirms Robert Califf as FDA Commissioner. After over a year without a Senate-confirmed FDA lead, the Senate narrowly approved Dr. Robert Califf to be the next FDA Commissioner. Dr. Califf previously briefly served as FDA Commissioner at the end of the Obama Administration. However, his ties to the pharmaceutical industry since then brought new scrutiny. Commissioner Califf faces a significant workload in his new role, including working to successfully negotiate and deliver user fee agreements (UFA) to Congress for full consideration and passage. Current UFAs are set to expire on September 30, 2022, at which point the FDA would face significant furloughs and program funding shortages.

Senate Finance Committee Holds Second Hearing on Youth Mental Health. On February 15, the Senate Committee on Finance held a hearing on “Protecting Youth Mental Health: Part II – Identifying and Addressing Barriers to Care”. The hearing discussed the role telehealth can play in rural health and in schools by increasing access to specialty providers, acting to de-stigmatize mental health, fostering formal partnerships with community behavioral health providers and training non-mental health clinicians. There was also discussion concerning the challenges associated with telehealth, such as reimbursement, access to broadband, and state licensure requirements. The conversation also touched on the mental health workforce, specifically around adequate reimbursement in Medicaid.

This hearing follows last week’s committee hearing on February 8 which focused on a U.S. Surgeon General Advisory and call to action regarding the youth mental health crisis. Key members of the Committee are outlining comprehensive mental health legislation for consideration later this year. The House Energy and Commerce Committee also held a hearing on mental health on February 17, entitled “American’s in Need: Responding to the National Mental Health Crisis.”

ADMINISTRATION

CMS Reconsiders Direct Contracting Model. Under pressure from progressive Democratic members, the Biden Administration has been weighing changes to the Direct Contracting model. Direct Contracting models, including the Global, Professional and Geographic models, were created during the Trump Administration. The Global and Professional Direct Contracting models build on 10-years of accountable care organization (ACO) policy and represent the next step in the evolution from Pioneer and Next Generation ACO models, at the Centers for Medicare & Medicaid Services Innovation Center. A third option, the Geographic Direct Contracting model, seems to be provoking the most angst among lawmakers given that it would have allowed random attribution of beneficiaries and participation by a broader array of entity types. Notably, the Biden Administration placed the Geographic model on hold and to date, it has not been implemented.

Direct Contracting came under fire during the Senate Finance Committee hearing on February 2, entitled “The Hospital Insurance Trust Fund and the Future of Medicare Financing“, during which Chairwoman Elizabeth Warren (D-MA) called upon the Biden Administration to end the model immediately. However, this week the tenor of the debate seemed to change, as Don Berwick, a former Obama-era CMS Administrator, was quoted in the press saying it would be disruptive if the model were simply stopped cold and over 200 provider organizations urged the Administration to amend the model rather than ending it. An announcement on the future of the model, and any modifications, is expected soon.

Future Uncertain for the Public Health Emergency. The current national public health emergency (PHE) runs through April 16, 2022 and the Biden Administration has indicated it will give a 60-day notice before allowing the PHE to expire. This week, we passed the 60-day mark leaving many stakeholders anticipating a renewal. Calls to end the PHE are growing, particularly from Republicans. Some 70 House Republicans, led by Energy and Commerce Committee Republican lead Cathy McMorris Rodgers (R-WA), sent a letter to President Biden on February 10 calling on the Administration to submit a plan to end the PHE. This week, the Federation of American Hospitals, among others, weighed in with a letter to the Department of Health and Human Services expressing support for another PHE extension. Many health policy flexibilities are tied to the PHE, including telehealth flexibilities, state and federal regulatory modifications, and additional waivers for healthcare providers. Without congressional or agency action to extend or modify these flexibilities, stakeholders have noted that there may be adverse impacts across the health system.

QUICK HITS

  • The House Subcommittee on Immigration and Citizenship of the Committee on the Judiciary held a hearing entitled, “Is There a Doctor in the House? The Role of Immigrant Physicians in the U.S. Healthcare System” to examine the issues associated with immigrant physician’s ability to practice medicine in the United States.

  • The Medicaid Health Plans of America sent a letter to congressional lawmakers this week, detailing concerns around the impact a sudden end to the public health emergency would have on states’ federal Medicaid matching funds.

  • CMS released their quarterly health equity newsletter, which provided numerous research updates including those on trends in inequities under Medicare Advantage, disparities in influenza vaccination rates, and trends in hospital readmission rates.

  • Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced a bill that would extend the provider relief fund (PRF) spending deadline and would allow providers to use PRF funds throughout the PHE. It would also require HHS to release any outstanding COVID-19 relief by March 31, 2022. It does not include any new funding.

  • On February 17, the Department of Homeland Security (DHS) released a proposed rule on to change the previous Administration’s actions to broaden the so-called “public charge” rule. This rule is a measure used in the immigration application process to determine whether someone is likely to need to depend on the federal government. This proposed rule revises the definition to prevent the public charge rule from penalizing people who choose to access the public health benefits and other government services available to them.

NEXT WEEK’S DIAGNOSIS

Next week, both the House and Senate will be on recess giving lawmakers a brief week back in their districts before returning to Washington, DC to negotiate the FY 22 appropriations package. Additionally, decisions around funding for an additional COVID-19 relief and the expiration of healthcare policies tied to the PHE will likely garner congressional attention. Preparations are also under way for the State of the Union on March 1, 2022.

© 2022 McDermott Will & EmeryNational Law Review, Volume XII, Number 49
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About this Author

Debra Curtis Health Policy Attorney Congress McDermott Will Emery

Debbie is a highly respected health policy authority who helps clients advance their missions in Congress and beyond. With more than three decades of experience working both on the Hill and with the health insurance exchange marketplace, she helps clients execute payment strategy, see around the corner on policy and regulatory changes, and pursue effective advocacy. In addition, Debbie has deep experience working closely with payers, industry stakeholders and government officials at the federal, state and local levels.

During her 24 years as a...

202-756-8062
Madeline Hodge Health Policy Director McDermott Law Firm
Health Policy Director

Madeline advises and advocates for clients on key policy, legislative and regulatory matters. With more than 10 years of experience working on Capitol Hill and with healthcare leaders, she helps clients lobby, develop effective policy strategies and build their brand reputation and awareness in Congress and throughout the United States. Madeline also helps her clients form and foster strong relationships with health policy decision-makers on national and grassroots levels.

Madeline’s healthcare background includes leadership roles advocating for healthcare providers, with a specific...

202-951-6161
Kristen O’Brien Healthcare Executive McDermott Consulting
Execusitve

Kristen O’Brien is an accomplished healthcare executive with a deep understanding of regulatory advocacy and healthcare policy efforts.

Kristen offers a strong background and a keen eye for solutions to barriers and challenges impacting healthcare clients. With more than 10 years of experience, her work focuses on implementing new laws through the rulemaking process, as well as working with relevant agency officials to develop and improve agency guidance.

Kristen recently served as Principal of the Health Industry Policy and Regulatory Practice Group at a law and lobbying...

202-756-8964
Professional Advisor

Erica Stocker is a professional advisor in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office. Erica focuses primarily on health care, including provider reimbursements, quality of care and patient safety.

202 756 8334
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