What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, July 11
    • Senate HELP Committee, “Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine.” Additional Information

Notable Policy Events – 

  • Tuesday, July 11 to Friday, July 14
    • Heritage Value-Based Care Conference Series, “The National Advanced Health Care at Home Summit” featuring Sirona Strategies Partner, Krista Drobac. Additional Information
  • Wednesday, July 12
    • Office of the National Coordinator for Health Information Technology (ONC), “ONC Health IT Certification Program Developer Roundtable.” Additional Information
  • Thursday, July 13

Weekly Wrap-Up: Notable Health Care Developments from Last Week

Executive Action – On July 7, the Biden Administration announced new actions to lower health care costs, protect consumers from short-term and fixed indemnity insurance, provide guidance on surprise medical billing, and released a request for information (RFI) on medical payment products that contribute to high health care costs and medical debt. Fact Sheet Press Release Guidance RFI

Medicare –

  • On June 27, CMS released the latest enrollment data for Medicare, Medicaid, and CHIP. As of March 2023, 65,748,297 people are enrolled in Medicare and 93,876,834 people are enrolled in Medicaid and CHIP. Enrollment Data
  • On June 28, CMS announced that it was making additional nursing home ownership data publicly available, including names of affiliated owners. Nursing Home Care Compare
  • On June 29, the HHS Office of Inspector General (OIG) released a resource guide for using Medicare’s enrollment rate and ethnicity data to support health equity work. Resource Guide
  • On June 30, CMS released a proposed rule to update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2024. Comments are due by August 25, 2023. Proposed Rule
  • Also on June 30, CMS issued the calendar year 2024 Home Health PPS Rate Update proposed rule, which updates Medicare payment policies and rates for Home Health Agencies. Fact Sheet Proposed Rule
  • Also on June 30, CMS announced revised guidance for the Medicare Drug Price Negotiation Program for the implementation of the Inflation Reduction Act. Notice Press Release
  • On July 7, CMS released the Medicare Program: Hospital Outpatient Prospective Payment system (OPPS): Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 proposed rule, which outlines a proposed remedy that will affect nearly all hospitals paid under the OPPS. Comments are due by September 5, 2023. Proposed Rule Fact Sheet

Medicaid –

  • On June 27, CMS released guidance to states outlining new mandatory coverage requirements for approved adult vaccines in Medicaid and CHIP. Guidance Fact Sheet
  • On June 28, the Government Accountability Office (GAO) released a report on the Medicaid Recovery Audit Contractor (RAC) program. The report highlights States’ use of the program, CMS’ oversight, and opportunities for CMS to improve the program. GAO’s review found that 34 states and the District of Columbia did not participate in this program during fiscal year 2021. Most states cited having other program-integrity initiatives as the reason for requesting an exemption Report
  • On July 3, CMS announced that it is publishing all state directed payment preprints on Medicaid.gov to provide transparency into state directed payments. Approved State Directed Payment Preprints

Marketplaces –

  • On July 5, CMS posted the Final 2023 Call Letter for the Quality Rating System (QRS) and the Qualified Health Plan (QHP) Enrollee Experience Survey. Call Letter
  • On July 7, HHS, the Department of Labor, and the Department of the Treasury issued a proposed rule that would amend the definition of short-term, limited-duration insurance (STLDI) among other provisions. Comments are due September 10, 2023. Proposed Rule Fact Sheet

Payment & Delivery System Models –

  • On June 27, CMS announced the 67 oncology physician group practices participating in the Enhancing Oncology Model (EOM), which launched on July 1, 2023. EOM Participants
  • On June 28, CMS released a frequently asked questions (FAQ) document for the Making Care Primary Model. CMS will continue to add common questions and answers as they become available. FAQs

Public Health Prevention, Preparedness, Surveillance & Data –

  • On June 29, CDC recommended that people ages 60 years and older get the RSV vaccine. Press Release Statement from HHS Secretary Becerra
  • Also on June 29, CDC released a report finding that the majority of people with hepatitis C still have not been cured nearly a decade after breakthrough treatments that clear the viral infection were first approved. CDC is looking to use these statistics to highlight the need for a proposed national program to end hepatitis C in the U.S. Press Release Report
  • On July 3, Senate HELP Committee Chair Sanders (I-VT), Ranking Member Cassidy (R-LA), and Sens. Casey (D-PA) and Romney (R-UT) released the bipartisan discussion draft to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). Comments are due by July 10.  Press Release Draft Legislation

Health IT, Privacy, & Digital Health – On July 3, HHS OIG released a final rule titled, “Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General’s Civil Money Penalty Rules”. This rule amends the civil money penalty (CMP) regulations of HHS OIG to incorporate new CMP authority for information blocking; incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; and increase the maximum penalties for certain CMP violations. The final rule is effective August 2, 2023. Final Rule

Mental Health and Substance Use Disorder Policy –

  • On June 27, SAMHSA released the Mental and Substance Use Disorders Prevalence Study, which provides updated national prevalence estimates for a number of mental and substance use disorders. Study Press Release
  • On June 28, SAMHSA awarded $31.5 million in behavioral health grants for children, youth and young adults. Press Release

Prescription Drugs, Medical Devices, Biomedical Research, & Health Innovation –

  • On July 5, Senate HELP Committee Ranking Member Cassidy (R-LA) penned an op-ed in STAT News outlining his approach to lowering drug prices. Press Release Op-Ed
  • On July 6, the FDA converted Leqembi, a treatment for adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Press Release

Population Health, Public Health & Health Equity –

  • On June 26, the Biden Administration awarded $50 million to launch the Persistent Poverty Initiative, an initiative to alleviate the cumulative effects of persistent poverty on cancer outcomes by building research capacity, fostering cancer prevention research, and promoting the implementation of community-based programs. Press Release
  • On June 28, HHS released a report highlighting evidence-based interventions to support physical activity among adults ages 65 years and older. Press Release Report 
  • Also on June 28, HHS Office of Minority Health (OMH) released a guide highlighting resources for advancing equity for Asian American, Native Hawaiian and Pacific Islander communities in COVID-19 response efforts. Blog Post Resource Guide
  • On June 29, the CMS OMH announced a new funding opportunity for the Health Equity Data Access Program (HEDAP), which assists researchers in gaining access to CMS restricted data for minority health research. The deadline to submit applications is Tuesday, August 15, 2023. Grant Information
  • Also on June 29, HHS released a request for information (RFI) on its Draft 2023 Framework to Support and Accelerate Smoking Cessation. Comments are due July 30, 2023. Fact Sheet RFI

Health Systems & Health Care Workforce –

  • On July 3, the Health Resources and Services Administration (HRSA) released a notice with all health professional shortage areas (HPSAs) in a designated status as of April 28, 2023. Notice
  • On July 6, HHS Secretary Becerra announced the HHS Health Workforce Initiative which is focused on federal investments to support, strengthen and grow the health workforce, including physicians, nurses, behavioral health care providers, and community health workers. Press Release

Misc. –

  • On June 26, the Congressional Budget Office (CBO) sent a letter to Senate Budget Chair Whitehouse (D-RI) on CBO’s work related to climate change and health care delivery systems. Letter 
  • Also on June 26, the Indian Health Service (IHS) released an update to its 2023 IHS Agency Work Plan, which is nearing the completion of its second quarter and demonstrating progress, with 92 percent of activities complete or on track to reach target goals. Press Release Second Quarter Update

Legislative Activity –
Introduced Legislation –

  • On June 27, Rep. Schiff (D-CA) and 30 cosponsors introduced the Equal Access to Reproductive Care Act (H.R. 4391), which would treat certain assisted reproduction expenses as medical expenses of the taxpayer. Bill Text Press Release
  • Also on June 27, Rep. Schiff (D-CA) and 53 cosponsors introduced the PrEP Access and Coverage Act (H.R. 4392), which would increase access to pre-exposure prophylaxis to reduce the transmission of HIV. Sen. Smith (D-MN) introduced the companion legislation in the Senate (S. 2188) on June 22. Bill Text Press Release
  • On June 30, Rep. Cleaver (D-MO) introduced the Reentry Resource Guide Act (H.R. 4404), which would establish a pilot program to develop, expand, and maintain digital community resource guides to advance the reentry efforts of individuals returning to their communities after incarceration. Bill Text Press Release
  • Also on June 30, Rep. Green (R-TN) introduced the States Choose Life Act of 2023 (H.R. 4414), which would prohibit requiring a recipient or subrecipient of funds to provide referrals for abortion. Bill Text Press Release
  • Also on June 30, Rep. Newhouse (R-WA) and six bipartisan cosponsors introduced the Law Enforcement Officers Preventing Overdose Deaths Act (H.R. 4431), which would provide for a pilot program under the Comprehensive Opioid Abuse Grant Program for local law enforcement agencies located in rural areas to purchase naloxone to prevent and reduce opioid overdose deaths. Bill Text Press Release
  • Also on June 30, Rep. Salazar (R-FL) and eight bipartisan cosponsors introduced the John W. Walsh Alpha-1 Home Infusion Act (H.R. 4438), which would provide for coverage and payment of Alpha-1 Antitrypsin Deficiency Disorder treatment under part B. Bill Text Press Release
  • On July 6, Reps. Arrington (R-TX), Lesko (R-AZ), and Burgess (R-TX) introduced the Medicare Patient Access to Cancer Treatment (MPACT) Act of 2023 (H.R. 4473), which would provide for site neutral payment for cancer care services under part B of the Medicare program. Press Release