POLICY BRIEFINGS

---

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 Key Policy Personnel
• Guide to the 118th Congress

THIS WEEK'S BRIEFING - APRIL 17, 2023

---

• President Biden Signs Resolution Terminating the COVID-19 National Emergency
• Democratic Senators Request Continued Coverage of Free At- Home Covid Tests
• Continuous Enrollment in Medicaid Begins Unwinding
• HHS Announces National Cancer Plan to Advance Cancer Moonshot
• Nursing Workforce Survey Released
• Republican Health Committee Leaders Raise Concerns with Biden Administration Drug Price Setting Guidance
• Senate HELP Committee Drug Pricing Markup Postponed
• Democratic Health Committee Leaders Seek Information from Health Plans on Preventive Care Coverage After Court Ruling
• HHS Proposes New Rule on Transparency for Artificial Intelligence
• States, Federal Government Consider Scope of Practice Legislation
• Senators Return to Capitol Hill, but Senate Majority Continues to Lack Full Operating Capacity
• EPA Proposes to Reduce Exposure to Gas Used to Sterilize Medical Devices
• Upcoming Congressional Hearings and Markups
• Recently Introduced Health Legislation

President Biden Signs Resolution Terminating the COVID-19 National Emergency

On April 10, President Biden signed into law H.J. Res. 7, the Pandemic is Over Act, a joint resolution terminating the national emergency related to the COVID-19 pandemic. The Biden administration previously announced its intention to end both the COVID-19 pandemic national emergency and public health emergency (PHE) declarations on May 11, 2023. Congress acted to end the national emergency ahead of this timeline. The House of Representatives adopted H.J.Res.7 at the end of January with 11 Democrats joining House Republicans supporting the measure. The Senate adopted the joint resolution on March 29 by a vote of 68 to 23. President Biden’s signature on H.J. Res. 7 puts an end to the COVID-19 national emergency originally declared on March 13, 2020—which provided a framework for the Secretary of the U.S. Department of Health and Human Services (HHS) to exercise certain emergency authorities with appropriate congressional oversight. According to the Centers for Medicare and Medicaid Services (CMS), the end of the national emergency, “does not impact current operations at HHS, and does not impact the planned May 11 expiration of the federal PHE for COVID-19 or any associated unwinding plans...any existing waivers currently in effect and authorized under the 1135 waiver authorization for the pandemic, would remain in place until the end of the federal PHE for COVID-19.”

Democratic Senators Request Continued Coverage of Free At- Home Covid Tests

On April 4, Senators Bob Casey (D-Pa.), Chairman of the Senate Special Committee on Aging, and Ron Wyden (D-Ore.), Chairman of the Senate Finance Committee, led a group of nearly 20 Senators in sending a letter to HHS Secretary Xavier Becerra urging the agency to continue providing Medicare coverage of rapid, at-home COVID-19 tests beyond the termination of the PHE. In the letter, the senators argue for continued Medicare coverage for the tests, stating, “Easy access to testing with quick results has prevented the spread of COVID-19, reduced severe infection, and enabled many Americans to resume normal life... Ending Medicare coverage for at-home COVID-19 tests could undo much of this progress and make it harder for Medicare beneficiaries to obtain accurate and timely information about their health. For example, without coverage under Medicare, many older Americans will not be able to afford to pay out-of-pocket for these critical tests and simply won’t test.” House Energy and Commerce Health Subcommittee Ranking Member Anna Eshoo (D-Ca.) sent a similar letter to the agency in September. The PHE is set to terminate on May 11, at which point access to free COVID-19 tests will end and coverage will vary by health plan.

Continuous Enrollment in Medicaid Begins Unwinding

Astatutory provision included in the Families First Coronavirus Response Act (FFCRA) required states to allow continuous enrollment in Medicaid, regardless of eligibility, through the end of the COVID-19 PHE in exchange for increased federal funding. Congress separated the provision from the PHE in the Consolidated Appropriations Act, 2023 and established a clear end date of April 1 for the provision. In January, CMS published an Informational Bulletin outlining timelines for states to unwind the requirement and submit a renewal redistribution plan. The Biden Administration estimates that upwards of 15 million individuals may lose Medicaid coverage as a result. Several states, including Arizona, Arkansas, Idaho, New Hampshire, and South Dakota have already started the disenrollment process.

HHS Announces National Cancer Plan to Advance Cancer Moonshot

On April 3, HHS announced the creation of a National Cancer Plan to advance the President and First Lady’s Cancer Moonshot vision of cutting cancer mortality by at least half within 25 years and improving quality of life for those impacted by cancer. Developed by the National Institutes of Health’s National Cancer Institute (NCI) in collaboration with the cancer community, the plan provides a framework for the federal government and all of society to collaborate to end cancer. The plan establishes eight goals and corresponding strategies, to: prevent cancer; detect cancers early; develop effective treatments; eliminate inequities; deliver optimal care; engage every person; maximize data utility; and optimize the workforce. The President’s Fiscal Year (FY) 2024 proposed budget requests Congress provide a $503 million increase from FY2023 levels for NCI and additional funding for the Cancer Moonshot initiative.

Nursing Workforce Survey Released

The National Council of State Boards of Nursing released a new survey titled “Examining the Impact of the COVID-19 Pandemic on Burnout & Stress Among U.S. Nurses.” The survey reveals that during the COVID-19 pandemic approximately 100,000 registered nurses retired or resigned due to stress and burnout. One-fifth of registered nurses are estimated to leave the nursing workforce by 2027. Reasons cited include increased workload, feeling emotionally drained and fatigued, among others. The survey also looked at the continued downward trend of the number of licensed practical/ vocational nurses.

Republican Health Committee Leaders Raise Concerns with Biden Administration Drug Price Setting Guidance

On April 12, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) wrote to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure voicing concerns with Inflation Reduction Act implementation guidance related to the drug price-setting provisions in the law. The letter emphasizes concerns, stating “This guidance exacerbates the law’s statutory flaws and compounds the profound uncertainty and risk posed by the legislation’s sweeping drug price controls. We encourage you to reconsider the many components of the initial guidance that will otherwise stifle medical innovation and quality improvement, discourage proven public- private partnerships, undermine American intellectual property (IP) protections, and provide unacceptable conditions for public feedback. If finalized as proposed, these provisions will serve to make bad policy worse, harming patients, caregivers, and health care providers across the United States for generations to come.” HHS published the initial program guidance on March 15 and provided a limited commenting opportunity that closed on April 14. By September 1, the agency will announce the first set of Medicare Part D drugs subject to price negotiation under the program. In 2026, a maximum of ten high-expenditure Part D drugs will have maximum fair prices set under the program.

Senate HELP Committee Drug Pricing Markup Postponed

The Senate Health, Education, Labor and Pensions (HELP) Committee has postponed an anticipated markup of bipartisan drug pricing legislation. The new legislation has yet to be made public but is expected to focus on policies related to pharmacy benefit managers (PBMs) and generics, potentially drawing from previous proposals on these topics. Staff indicated that the committee is waiting for a significant amount of technical assistance before proceeding. Earlier this year, the committee announced a series of planned, closed-door roundtables to hear from experts on several topics. The committee has heard and will continue to hear from a range of industry experts, including innovative drug makers, the generics and biosimilars industries, and PBMs.

Democratic Health Committee Leaders Seek Information from Health Plans on Preventive Care Coverage After Court Ruling

On March 30, a federal judge’s ruling in Texas struck down an Affordable Care Act (ACA) requirement for health plans to fully cover certain preventative healthcare services recommended by the U.S. Preventive Services Task Force without cost-sharing. In response, five Democratic health committee leaders sent letters to 12 health plans seeking information on future coverage plans for preventive services, such as mammograms and screenings for cervical cancer, colorectal cancer, osteoporosis, hepatitis B virus, HIV, and lung cancer. In the letter, the committee leaders state, “We are very concerned that the decision will unnecessarily cause confusion, force consumers to pay out-of-pocket, and result in patients foregoing preventive services screenings and treatment altogether. There is evidence that even modest cost-sharing deters patients from accessing care and exposure to cost-sharing reduces the use of preventive care. We are very concerned that the decision will roll back the significant health care gains that have been made under the ACA and will worsen racial and ethnic inequities.” The letter was signed by House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.), House Ways and Means Committee Ranking Member Richard Neal (D-Mass.) House Education and the Workforce Ranking Member Robert “Bobby” Scott (D-Va.), Senate Finance Committee Chairman Ron Wyden (D-OR), and Senate HELP Committee Chairman Bernie Sanders (I-Vt.). On April 13, U.S. Department of Justice announced it was seeking a stay in Braidwood v. Becerra. HHS Secretary stated that “President Biden, and this entire Administration, will do everything possible to protect and defend Americans’ right to the health care they need and deserve.”

HHS Proposes New Rule on Transparency for Artificial Intelligence

On April 11, the HHS Office of the National Coordinator (ONC) issued a notice of proposed rulemaking (HT1-1 proposed rule) to alter the ONC Health IT Certification Program. The HTI-1 proposed rule would implement provisions of the 21st Century Cures Act and according to the agency, seeks to “advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.” As part of the rulemaking, those creating Artificial Intelligence (AI) used in health care will be required to publicly disclose information on data used to inform algorithms to receive HHS’ certification. Currently, certification is voluntary except for certain technologies. The Food and Drug Administration (FDA) has also taken steps to regulate AI. Earlier in April, FDA issued draft guidance related to increasing patient access to AI/machine learning-enabled devises to advance public health. The HTI-1 proposed rule will be formally published on April 18 and public comments will be accepted through June 20, 2023.

April 17, 2023: | Page 1 Page 2 Page 3