Washington Healthcare Update

July 24, 2023

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This Week in Washington: House Energy and Commerce Committee marks up 15 healthcare bills; Senate HELP Committee to hold mark up on primary care bill; CMS concerned over procedural Medicaid coverage terminations

Upcoming Hearings

Congress

House

Senate

Administration

Other Activity

Proposed Rules

Final Rules

CBO Cost Estimates

Upcoming Hearings

July 26

Senate

Senate Committee on Veterans’ Affairs Full Committee Hearing: “Implementing the PACT Act: One Year Later”
3:00 p.m., Russell Senate Office Building 418
Witnesses to be announced.

July 27

House

House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic Hearing: “Because I Said So: Examining the Science and Impact of COVID-19 Vaccine Mandates”
2:00 p.m., Rayburn House Office Building 2154
Witnesses to be announced.

House

House Energy and Commerce Committee Marks Up 15 Healthcare Bills

On July 19, the House Energy and Commerce Committee reported out of committee 15 healthcare bills. The bills are:

  • H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023

This legislation would expand COVID-19 telehealth flexibilities issued by the Departments of Health and Human Services (HHS), Labor and the Treasury, and allow employers to offer stand-alone coverage of telehealth-only services to employees.

  • H.R. 3226, Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act of 2023

This legislation would reauthorization the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Act for fiscal years (FYs) 2024 to 2028. It would direct the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) to strengthen efforts to reduce preterm births and infant mortality and would authorize a new study to analyze the financial costs of premature births on society.

  • H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023

This legislation would reauthorize federal support of state efforts to address disparities that exist in maternal health outcomes. It would require the CDC to work with HRSA to inform hospitals and healthcare providers of maternal mortality prevention strategies.

  • H.R. 3843, Action for Dental Health Act of 2023

This legislation would reauthorize Section 340G of the Public Health Service Act to address dental workforce needs.

  • H.R. 3884, Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023

This legislation would reauthorize Section 1106 of the Public Health Service Act for FYs 2024 to 2028 to continue research and treatment services.

  • H.R. 3821, Firefighter Cancer Registry Reauthorization Act of 2023

This legislation would reauthorize funding for FYs 2024 to 2028, for a voluntary CDC registry used to report firefighter cancer incidents.

  • H.R. 3391, Gabriella Miller Kids First Research Act 2.0

This legislation would reauthorize funding through FY 2028 for the National Institutes of Health (NIH) Gabriella Miller Kids First Pediatric Research Program. It would also enhance the coordination of federal pediatric cancer research efforts and require HHS to report on federally funded pediatric cancer research programs and initiatives.

  • H.R. 4421, Preparing for All Hazards and Pathogens Reauthorization Act

This legislation would reauthorize federal programs supporting public health security and all-hazards response, the Biomedical Advanced Research and Development Authority (BARDA), the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and the Strategic National Stockpile (SNS). It would also contain provisions aimed at streamlining emergency response authorities and medical countermeasure research and enhancing transparency across federal agencies.

  • H.R. 4420, Preparedness and Response Reauthorization Act

This legislation would reauthorize CDC programs that support the distribution of medical countermeasures and the control of biological agents and mosquito-borne diseases. It would also strengthen epidemiological monitoring.

  • H.R. 4529, Public Health Guidance Transparency and Accountability Act of 2023

This legislation would require the CDC to implement public participation requirements prior to finalizing and implementing guidance. It would also clarify that CDC guidance is nonbinding.

  • H.R. 4381, Public Health Emergency Congressional Review Act

This legislation would establish a congressional review process for a public health emergency (PHE) and would allow Congress to consider and vote on terminating a PHE six months after it was declared.

  • H.R. 3813, CDC Leadership Accountability Act of 2023

This legislation would require any director of the CDC appointed by the president on or after June 1, 2023, to be confirmed by the Senate.

  • H.R. 3836, Medicaid Primary Care Improvement Act

This legislation would clarify that current Medicaid law does not prohibit state Medicaid programs from using direct primary care to provide services to Medicaid beneficiaries. It would also require the Centers for Medicare and Medicaid Services (CMS) to report to Congress on existing Medicaid primary care contracting arrangements.

  • H.R. 4531, Support for Patients and Communities Reauthorization Act

This legislation would reauthorize portions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. It would reauthorize public health programs related to substance use disorder prevention, treatment and recovery and the permanent extension of Medicaid’s required coverage of medication-assisted treatments.

  • H.R. 3887, Children’s Hospital GME Support Reauthorization Act

This legislation would reauthorize payments to children’s hospitals that have Graduate Medical Education programs for FYs 2024 to 2028. It would also prohibit payments to children’s hospitals that furnish specified procedures or drugs for minors.

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter to FDA over Foreign Drug Manufacturing Inspections

On July 18, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chairman Brett Guthrie (R-KY) and Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf concerning FDA-led foreign drug manufacturing inspections. The FDA recently decided to allow the import of drugs from India and China to alleviate the ongoing U.S. critical drug shortage. The members are concerned that this decision may lead to drug products entering the U.S. that are in violation of FDA safety regulations.

For more information, click here.

Senate

Senate HELP Committee Marks Up Pandemic and All-Hazards Preparedness and Response Act

On July 20, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up and voted in favor of authorizing the Pandemic and All-Hazards Preparedness and Response (PAHPARA) Act. The legislation would improve U.S. biosecurity capabilities and pandemic preparedness and response capabilities among state and federal healthcare agencies. The legislation would:

  • Improve planning and coordination efforts among federal agencies during public health emergencies, natural disasters and biological, chemical and nuclear threats;
  • Reauthorize the Hospital Preparedness Program;
  • Update the National Health Security Strategy, the Annual Threat-Based Review for the Strategic National Stockpile (SNS), the Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP);
  • Encourage the Biomedical Advanced Research and Development Authority (BARDA) to support innovate medical countermeasures and identify virus families with significant pandemic potential; and
  • Direct the Government Accountability Office (GAO) to study the economic impact and health outcomes of COVID-19 response strategies.

During the markup, the committee adopted two amendments offered by Sens. Budd (R-NC), Hassan (D-NH) and Hickenlooper (D-CO) that seek to strengthen the SNS and establish an emerging pathogen preparedness program at the Food and Drug Administration (FDA).

For more information, click here.

Senate HELP Committee Chairman Introduces Primary Care Bill

On July 19, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sander (I-VT) introduced the Primary Care and Health Workforce Expansion Act. The legislation would:

  • Authorize $86.5 billion in funding for the Community Health Center Fund, the National Health Service Corps, the Children’s Hospital Graduate Medical Education Program, the Teaching Health Center Graduate Medical Education Program, the Primary Care Training and Enhancement Program and other education and loan repayment programs through fiscal year (FY) 2028;
  • Require insurance plans to use electronic prior authorization forms;
  • Prohibit insurance plans from imposing duplicate prior authorization requirements on patients who switch their health plans while receiving treatment;
  • Prohibit hospitals from charging facility fees when patients receive care from off-site physicians;
  • Prohibit hospitals and physicians from billing separately for a given service; and
  • Cap hospital and physician fees to equal no more than the median amount that health plans and issuers pay for the service in a physician’s office.

The legislation is the Chairman’s response to a bill introduced last week by HELP Committee Ranking Member Bill Cassidy (R-LA) that also seeks to reauthorize various primary care and medical education programs. The Chairman and Ranking Member have been unable to agree on funding levels and negotiations have stalled between their staff. A markup of the Chairman’s bill has been scheduled for July 26.

For more information, click here.

Senate Finance Committee to Consider PBM Legislation on July 26

The Senate Finance Committee will hold a markup on July 26 to consider legislation to reform pharmacy benefit managers (PBM). The legislation builds upon the bipartisan framework released in April and a subsequent draft released by Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID).

For more information, click here.

Seventeen Senators Send Letter Concerning HIPAA Privacy Regulations

On July 18, Senate Finance Committee Chairman Ron Wyden (D-OR) and Senate Appropriations Committee Chairman Patty Murray (D-WA) led a group of 17 senators and 28 members of the House of Representatives in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra. The letter urges HHS to add additional provisions to a proposed rule that HHS issued in April that seeks to strengthen federal privacy requirements under the Health Insurance Portability and Accountability (HIPAA) Act. The members are urging HHS to:

  • Require law enforcement agencies to obtain a warrant before requiring doctors, pharmacists and healthcare providers to pass along patient health information (PHI);
  • Prohibit PHI from being shared among law enforcement agencies unless it is needed to further an investigation specified in a warrant application; and
  • Inform patients when their PHI is shared with law enforcement agencies.

For more information, click here.

SUPPORT for Patients and Communities Reauthorization Act of 2023 Introduced

On July 20, Senate Health, Education, Labor and Pensions (HELP) Ranking Member Bill Cassidy (R-LA) introduced the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Reauthorization Act of 2023. The legislation would reauthorize programs that support mental illness and substance use-disorder prevention, treatment and recovery services. It would also:

  • Reauthorize programs that support first responder training, child and youth mental health, pregnant and postpartum women, and work-reentry;
  • Increase access to treatment for patients with treatment-resistance depression;
  • Direct the Food and Drug Administration (FDA) to carry out a review of at-home drug disposal standards and systems;
  • Require the Department of Labor (DOL) to report on the 25-year implementation of mental health parity laws;
  • Direct the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) to issue a special registration process for practitioners who prescribe controlled substances via telehealth; and
  • Provide guidance to states on how to treat children with serious emotional disturbance and individuals with serious mental illness.

In addition, on July 19 the House Energy and Commerce Committee reported its version H.R. 4531, the Support for Patients and Communities Reauthorization Act out of committee.

For more information, click here.

PBM Oversight Act of 2023 Introduced

On July 20, Sens. Carper (D-DE) and Grassley (R-IA) introduced the PBM Oversight Act of 2023. The legislation would increase oversight over the practices pharmacy benefit managers (PBMs) use to determine which medications are included on drug formularies and would require the Government Accountability Office (GAO) to conduct a study on the practices and report their findings to Congress. It would also require the GAO to study the practices that pharmacy and therapeutic committees use when developing drug formularies under Medicare Part D.

For more information, click here.

Administration

White House Launches Office of Pandemic Preparedness and Response Policy

On July 21, the White House announced that it had established the Office of Pandemic Preparedness and Response Policy (OPPR). The OPPR will be a permanent office within the Executive Office of the President (EOP) and will be responsible for leading and coordinating preparedness and response actions in response to biological threats, pathogens and other public health disruptions. It will be led by Ret. Major General Paul Friedrichs, who currently serves as Special Assistant to the president and Senior Director for Global Health Security and Biodefense at the National Security Council (NSC).

For more information, click here.

FTC and DOJ Release Draft Merger Guidelines

On July 19, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) released 13 draft merger guidelines that seek to prevent anticompetitive mergers and strengthen federal antitrust laws. The guidelines could have a substantial impact on the healthcare industry due to the relatively high number of mergers and acquisitions that occur among healthcare entities.

The 13 guidelines are:

  • Mergers should not significantly increase concentration in highly concentrated markets;
  • Mergers should not eliminate substantial competition between firms;
  • Mergers should not increase the risk of coordination;
  • Mergers should not eliminate a potential entrant in a concentrated market;
  • Mergers should not substantially lessen competition by creating a firm that controls products or services that its rivals may use to compete;
  • Vertical mergers should not create market structures that foreclose competition;
  • Mergers should not entrench or extend a dominant position;
  • Mergers should not further a trend toward concentration;
  • When a merger is part of a series of multiple acquisitions, the agencies may examine the whole series;
  • When a merger involves a multi-sided platform, the agencies examine competition between platforms, on a platform or to displace a platform;
  • When a merger involves competing buyers, the agencies examine whether it may substantially lessen competition for workers or other sellers;
  • When an acquisition involves partial ownership or minority interests, the agencies examine its impact on competition; and
  • Mergers should not otherwise substantially lessen competition or tend to create a monopoly.

The FTC and DOJ are seeking public comment on the guidelines and comments will be accepted until Sept. 18, 2023.

For more information, click here.

CMS Concerned Over Procedural Medicaid Coverage Terminations

On July 19, Director of the Centers for Medicare and Medicaid Services (CMS) Center for Medicaid and CHIP Services Daniel Tsai announced that CMS is concerned over the high number of individuals who are losing Medicaid coverage due to procedural reasons in at least 12 states. An estimated 3 million people have lost coverage since April and data indicates that 75 percent of these disenrollments were due to procedural reasons.

According to data CMS released on July 19, nine states have agreed to pause procedural Medicaid terminations. These include DE, ID, IA, ME, MN, MS, NY, WV and WY.

CMS has issued mitigation plans to several states that are in violation of federal Medicaid renewal requirements. Many states were issued mitigation plans because their renewal forms were requesting more information than was necessary to determine eligibility. Approximately 20 states were not allowing beneficiaries to make use of all modalities to renew their coverage, including phone, mail, in-person and online resources. Twenty-six states were issued mitigation plans because they were not conducting renewals ex parte.

In addition, on July 20, CMS Administrator Chiquita Brooks-LaSure sent a letter to employers and health plan sponsors, urging them to extend the special enrollment periods for group health plans beyond the 60-day minimum. The administrator argued that more time will be needed due to the resumption of Medicaid and CHIP renewals.

For more information on the data released by CMS, click here.

For more information on the CMS Administrator’s letter, click here.

CMS Approves Two Requests for Mobile Crisis Team Behavioral Health Services

On July 20, the Centers for Medicare and Medicaid Services (CMS) approved requests submitted by California and Kentucky to provide behavioral health services through mobile crisis intervention teams. The two states will now be able to utilize mobile crisis teams to provide Medicaid services and assist eligible individuals with accessing behavioral health services. Mobile crisis teams are trained to provide rapid response, individual assessment and crisis de-escalation services.

For more information, click here.

CMS Proposes Medicare Part A and B Coverage for HIV Prophylaxis Drugs

On July 12, the Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo that recommends Medicare Part A and B plans cover oral and injectable pre-exposure prophylaxis (PrEP) drugs for HIV. CMS is also proposing that Medicare Part A and B plans:

  • Cover the administration of injectable PrEP using antiretroviral drugs;
  • Seven individual counseling visits every 12 months including an initial HIV risk assessment; and
  • Seven HIV screenings and one hepatitis B screening per year for seniors currently taking PrEP drugs.

Public comments on the proposed coverage policy will be accepted until Aug. 11 and CMS will issue a final national coverage determination (NCD) in October.

For more information, click here.

FDA Approves RSV Monoclonal Antibody Treatment for Infants

On July 17, the Food and Drug Administration (FDA) approved Beyfortus (nirsevimab-alip), a monoclonal antibody drug intended to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates, infants and children up to 24 months of age. The FDA decided to approve the drug after three clinical trials revealed that the incidence of medically attended RSV lower respiratory tract infection was lower among infants who received the drug versus those who