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.


THIS WEEK'S BRIEFING - APRIL 19, 2021


Medicare Sequester Moratorium Extended


Last week, the House of Representatives cleared legislation to delay Medicare sequestration cuts for an additional nine months. The House voted 384 to 38 to pass H.R. 1868, which had previously passed the Senate on March 25; the President signed the bill on April 14. The law suspends, through Dec. 31, Medicare sequestration that would reduce provider payments by 2% annually as required by the 2011 Budget Control Act. The cuts were initially scheduled to take effect at the end of last month, but the Centers for Medicare and Medicaid Services (CMS) has been holding claims given the expected moratorium


House Passes Slate of Health Bills


The House of Representatives passed a slate of health care-related bills last week under suspension of the rules. Bills advanced by the chamber include:

  • FASTER Act of 2021 (S.578), which would add sesame to the Food and Drug Administration’s (FDA) list of major food allergens beginning in 2023. The bill was previously passed by the Senate in March.
  • John Lewis NIMHD Research Endowment Revitalization Act of 2021 (H.R.189), which would permit the National Institute on Minority Health and Health Disparities (NIMHD) to provide research endowments to current and former centers of excellence at minority academic institutions.
  • TRANSPLANT Act of 2021 (H.R.941), which would reauthorize stem cell programs at the U.S. Department of Health and Human Services (HHS) through fiscal year (FY) 2026.
  • Advancing Education on Biosimilars Act of 2021 (S.164), which would direct HHS to create a central website for educational materials on biosimilars. The bill was passed by the Senate in March.
  • S. 415, which would narrow the criteria for a drug to receive exclusivity as a new chemical entity. The bill was passed by the Senate in March.
  • Debarment Enforcement of Bad Actor Registrants (DEBAR) Act of 2021 (H.R.1002), which would give the Drug Enforcement Administration (DEA) the authority to prohibit any person from registering to manufacture or dispense controlled substances if the individual has a history of suspended registrations.
  • Ensuring Compliance Against Drug Diversion Act of 2021 (H.R. 1899), which would require the DEA to terminate a person’s registration to manufacture or dispense controlled substances if they die, terminate their business, or surrender the registration.

The House also passed the Workplace Violence Prevention for Health Care and Social Service Workers Act (H.R. 1195) by a vote of 254-166. The legislation would require the Department of Labor to issue a rule requiring health care and social service employers to implement workplace violence prevention plans, defining workplace violence as any act or threat of force against an employee that could result in a physical injury, psychological trauma, or stress.


Ways and Means Ranking Member Brady Announces Retirement


Rep. Kevin Brady (R-Texas), Ranking Member of the House Ways and Means Committee, has announced that he will not seek reelection next year. Brady has served in the House since 1997 and has served as the top Republican on Ways and Means since 2015. He cited the GOP internal rule term limiting members to six consecutive years of committee leadership as a factor in his decision. Rep. Devin Nunes (R-Calif.) is the next most senior member of the committee, but he would have to step down from his position as ranking member of the House Intelligence Committee should he wish to lead Ways and Means. Brady’s Houston-area district is not expected to become competitive for Democrats in the 2022 midterm elections.


E&C Leaders Encourage Enforcement of Hospital Transparency Rule


Bipartisan leadership of the House Energy and Commerce Committee have sent a letter to the U.S. Department of Health and Human Services (HHS) expressing concerns about the implementation of the Trump administration’s Hospital Price Transparency Final Rule. The lawmakers cite reports of hospitals failing to comply with the new regulation, which went into effect on Jan. 1, 2021, and urge HHS “to revisit its enforcement tools, including the amount of the civil penalty, and to conduct regular audits of hospitals for compliance.” Under the regulation, hospitals are required to make public a machine-readable file listing all standard charges for items and services and to publish charges for the hospital’s 300 most shoppable services in a consumer-friendly format. The letter to HHS Secretary Xavier Becerra was signed by Chair Frank Pallone (D-N.J.), Ranking Member Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Anna Eshoo (D-Calif.), and Health Subcommittee Ranking Member Brett Guthrie (R-Ky.).


President Biden to Address Congress April 28


President Joe Biden has accepted House Speaker Nancy Pelosi’s (D-Calif.) invitation to address a joint session of Congress on April 28. The speech will fall right before the President’s 100th day in office. The address will be held in the chamber of the House of Representatives, and House and Senate members are expected to attend. According to administration officials, however, other logistics for the address – including COVID-19 testing requirements and who will attend in person – have yet to be determined.


ACIP to Reconvene This Week Amidst Pause on J&J Vaccine


The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met last week to consider the details surrounding reports that six people who received Johnson & Johnson’s COVID-19 vaccine a type of blood clot called cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets (thrombocytopenia). The meeting followed a statement from regulators earlier in the week that recommended a pause to the use of the shot. ACIP decided not to vote on a recommendation for how to proceed, instead deciding to gather more data to evaluate the shot’s safety. The panel is tentatively scheduled to meet on Friday, April 23 from 11 am to 5 pm to continue consideration of the Johnson & Johnson vaccine.



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