Holland & Knight Health Dose: May 9, 2023

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Holland & Knight
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Holland & Knight is a global law firm with nearly 2,000 lawyers in offices throughout the world. Our attorneys provide representation in litigation, business, real estate, healthcare and governmental law. Interdisciplinary practice groups and industry-based teams provide clients with access to attorneys throughout the firm, regardless of location.
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
United States Food, Drugs, Healthcare, Life Sciences
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LEGISLATIVE UPDATES

This Week: Congressional Leaders Discuss Debt Limit

The debt limit is taking much of the oxygen in the room as the "Big Four" congressional leaders and President Joe Biden meet in the Oval Office to discuss the nation's debt limit and potential spending cuts. The leaders are currently entrenched in opposing positions on the debt limit with neither looking to budge. Recently, Republicans in the U.S. House of Representatives passed a partisan debt limit proposal. From a health perspective, the bill includes provisions that would instate work requirements for Medicaid recipients.

Meanwhile, Democrats are opposed to anything but a clean bill that would raise the debt limit, untethering spending cuts to the issue. Democratic leadership has indicated that once a clean debt limit bill is passed, then they will begin spending cut negotiations. Additionally, the work requirements are a nonstarter for Democrats controlling the U.S. Senate and the White House.

Additionally, there are several hearings being held over the next several days, making for another busy health week on Capitol Hill. After being postponed last week, the Senate Committee on Health, Education, Labor and Pensions (HELP) will be continuing its markup of legislation on improving access to generic drugs and increasing transparency into the work of pharmacy benefit managers. The committee will hear from top pharmacy benefit manager (PBM) executives regarding insulin pricing in a hearing on May 10, 2023. Other health-related hearings this week include the Senate Committee on Finance's hearing on May 11, 2023, regarding pharmaceutical manufacturers and U.S. international tax policy; a House Committee on Ways and Means' Subcommittee on Health hearing on May 10, 2023, to examine policies that inhibit innovation and patient access; and the House Committee on Veterans' Affairs' Subcommittee on Technology Modernization's hearing on May 10, 2023, on pharmacy electronic health record modernization.

Senate Democrats Seek to Improve Mental Health Provider Directories

Several democratic members of the Senate Committee on Finance recently took issue with Medicare Advantage's "ghost networks," or what they fear are inaccurate directories that could impact how seniors choose a plan. Senate Finance Chair Ron Wyden (D-Ore.) released the results of a "secret shopper" study conducted by the committee majority staff that showed an 18 percent success rate in making an appointment with a mental healthcare provider. The study is part of his greater effort to address ghost networks and ensure mental health provider directories are accurate, and it follows the committee's hearing on the same issue last week.

Senate HELP Committee Holds Hearing on PAHPA

The Senate HELP Committee held a hearing on May 4, 2023, on preparing for the next public health emergency and reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA). PAHPA is set to expire on September 30, 2023, unless Congress takes action to reauthorize it. During the hearing, federal officials such as Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky expressed concerns about the increased frequency of outbreaks and called on the U.S. to do more to prepare for future pandemics and biological threats. Members of both sides emphasized how critical reauthorization and expansion of PAHPA is not just to prepare for pandemics but any crisis.

REGULATORY UPDATES

The End of the PHE and Several Vaccination Requirements

May 11, 2023, marks the official end of the COVID-19 public health emergency (PHE). Notably, the Biden Administration announced it will end the COVID-19 vaccine requirements for federal employees, federal contractors and international air travelers at the end of the day on May 11, 2023. These vaccination requirements were announced in 2021 and will end on the last day of the COVID-19 PHE. The U.S. Department of Health and Human Services (HHS) also announced on May 8, 2023, that it will start the process to end vaccination requirements for Centers for Medicare & Medicaid Services (CMS)-certified healthcare facilities and Head Start educators. HHS is expected to release further information in the coming days on the unwinding of its vaccination requirements. As a reminder, this policy is applicable to facilities that participate in/are certified under the Medicare/Medicaid programs and are regulated by Conditions of Participation (CoPs), Conditions for Coverage (CfCs) or Requirements for Participation - physician practices were largely outside of the scope.

Tanden To Serve as Next Head of the Domestic Policy Council

According to recent reports, President Biden will soon name Neera Tanden as the next director of the Domestic Policy Council. Tanden will replace Susan Rice, who has announced her plans to leave the administration later this month. Tanden currently serves as White House staff secretary and senior adviser. She was previously nominated to lead the Office of Management and Budget (OMB) but withdrew from consideration after bipartisan objections to her use of social media to criticize political opponents. President Biden's deputy assistant, Stefanie Feldman, will replace Tanden as staff secretary.

Rochelle Walensky to Leave as CDC Director Next Month

Rochelle Walensky will leave her position as director of the CDC, a post she has held since the start of the Biden Administration. The agency announced that Walensky submitted a letter of resignation - the same day that the World Health Organization (WHO) declared the end of the COVID-19 global health emergency.

Walensky plans to step down on June 30, 2023.

USPSTF Plans Major Change to Breast Cancer Screening Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends biennial screening mammography for women ages 40 to 74 years. This recommendation forms the basis of a draft recommendation statement published on May 9, 2023. For women ages 40 to 74 years, the USPSTF recommends biennial screening mammography (B recommendation). Notably, the task force's previous recommendation was for women to start mammograms at 50, and for women ages 40-49 to consider it, depending on personal risk and discussions with their healthcare provider. For women aged 75 years and older, the current evidence is insufficient to assess the balance of benefits and harms of screening mammography (I statement). The evidence is also insufficient to assess the benefits and harms of supplemental screening for breast cancer using breast ultrasonography or magnetic resonance imaging (MRI) in women identified with dense breasts on an otherwise negative screening mammogram (I statement). The draft evidence review and recommendation statement are posted for public comment. Comments can be submitted from May 9 through June 5, 2023.

DEA Temporarily Extends COVID-19 Telehealth Flexibilities

The Drug Enforcement Administration (DEA) announced last week that it will continue to permit providers to prescribe controlled substances via telehealth as the agency works to finalize its related proposed regulations in response to the end of the COVID-19 PHE. The rules proposed in February 2023 would have allowed doctors to prescribe only an initial 30-day supply of certain DEA-regulated drugs through telehealth. For other drugs - including Adderall - patients would be required to complete an in-person visit with a provider before receiving a prescription. The DEA stated that it received a record number of comments in response to the proposed rules. It did not specify how long the temporary extension of the COVID-19 era flexibilities will last.

Additional details are available on the DEA website. In related news, a bipartisan group of senators sent a letter to the DEA calling on the agency to address gaps in patient access to the opioid use disorder drug buprenorphine.

SAMHSA Launches Behavioral Health Equity Challenge

The Substance Abuse and Mental Health Services Administration (SAMHSA) recently announced a behavioral health equity challenge to expand outreach and engagement for underserved racial and ethnic communities.

To participate in the challenge, health systems or hospitals can collaborate with community-based organizations and share their innovative strategies to improve care among underserved populations. SAMHSA will award $500,000 across 10 participant groups, with each winner expected to receive $50,000. Details are available on the SAMHSA website, and the deadline to submit materials is June 8, 2023.

CMS Accepting 2023 MIPS EUC and Promoting Interoperability Exceptions

The Centers for Medicare and Medicaid Services (CMS) opened applications for the Merit-Based Incentive Payment System (MIPS) Extreme and Uncontrollable Circumstances (EUC) Exception and the Promoting Interoperability Performance Category Hardship Exception for performance year 2023. The applications will close at 8 p.m. ET on Jan. 2, 2024.

New MACPAC Commissioners Named

The comptroller general of the Government Accountability Office (GAO) recently named new commissioners to the Medicaid and CHIP Payment and Access Commission (MACPAC). The new members are:

  • Timothy Hill, MPA, vice president for client engagement at the American Institutes for Research (AIR)
  • Carolyn Ingram, MBA, executive vice president of Molina Healthcare, Inc.
  • Patti Killingsworth, senior vice president of long-term services and supports (LTSS) strategy at CareBridge
  • John B. McCarthy, MPA, founding partner at Speire Healthcare Strategies
  • Adrienne McFadden, MD, JD, chief medical officer of Medicaid at Elevance Health
  • Jami Snyder, MA, president and chief executive officer of JSN Strategies LLC

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Holland & Knight Health Dose: May 9, 2023

United States Food, Drugs, Healthcare, Life Sciences
Contributor
Holland & Knight is a global law firm with nearly 2,000 lawyers in offices throughout the world. Our attorneys provide representation in litigation, business, real estate, healthcare and governmental law. Interdisciplinary practice groups and industry-based teams provide clients with access to attorneys throughout the firm, regardless of location.
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