Weekly Wrap-up and What’s Ahead

Hearings and Markups –

  • Tuesday, December 13
    • Senate Committee on Agriculture, Nutrition and Forestry, Subcommittee on Food and Nutrition, Specialty Crops, Organics, and Research, “Food as Medicine: Current Efforts and Potential Opportunities.” Additional information
    • House Committee on Veterans’ Affairs, “Review of the Role of VA’s Fourth Mission and Pandemic Response.” Additional information
  • Wednesday, December 14
    • House Committee on Veterans’ Affairs, Subcommittee on Health, “Reviewing the Program of Comprehensive Assistance for Family Caregivers.” Additional information
    • House Committee on Veterans’ Affairs, Subcommittee on Oversight and Investigations and Subcommittee on Technology Modernization, “Protecting the Privacy of Veterans’ Data.” Additional information
  • Thursday December 15
    • Senate Special Committee on Aging, “Setting the Table: Promoting Healthy and Affordable Food for Older Americans.” Additional information

Notable Policy Events –

  • Monday, December 12 – Tuesday, December 13
  • Monday, December 12
    • American Enterprise Institute, “The Relationship Between Substance Abuse and Child Welfare.” Additional information
    • CMS, “Addressing Health-Related Social Needs and Social Determinants of Health in Medicaid.” Additional information
    • Health Affairs, “Policy Spotlight: One-On-One with Ashish Jha, White House Coordinator of the COVID-19 Response.” Additional information
  • Tuesday, December 13
    • Brookings Institute, “Making Behavioral Health Work.” Additional information
    • Brookings Institute, “How are Federal Policies Affecting Seniors and Retirees in a post-COVID World?” Additional information
    • Center for Health Care Strategies, “Introduction to D-SNPs and D-SNP Contracting Basics.” Additional information
    • Kaiser Family Foundation, “What is the Future of Contraceptive Care in a Post-Roe World?” Additional information
    • National Academies of Sciences, Engineering, and Medicine (NASEM), “The Role of Business in Improving Health and Health Equity: A Workshop.” Additional information
  • Wednesday, December 14 – Thursday, December 15
  • Wednesday, December 14
  • Thursday, December 15
    • Better Care Playbook, “Integrating Bridge Clinics into Emergency Departments to Facilitate Access to Opioid Use Disorder Care.” Additional information
    • Center for Health Care Strategies, “Using D-SNPs to Integrate Care for Dually Eligible Individuals.” Additional information
    • CMS, “Medicare Ground Ambulance Data Collection System (GADCS): Overview of the Data Certifier Role.” Additional information
    •  Committee for a Responsible Federal Budget, “Health Solutions Summit: Options for the Next Congress.” Additional information
    • eHealth Exchange, “2022 Annual Meeting.” Additional information
    • Pandemic Response Accountability Committee, “Roundtable: How did states, cities, and counties involve their communities in the allocation of pandemic relief funds?” Additional information
    • Politico, “Who’s Caring? Family Care in America.” Additional information
    • U.S. News and World Report, “Inside the U.S. News Best Children’s Hospitals: A Quality Reporting Dialogue.” Additional information
  • Friday, December 16
    • Urban Institute, “Advancing Racial Equity in Our Communities: Involving Communities in Equitable Development.” Additional information

Weekly Wrap-Up: Notable Health Care Developments from Last Week
Medicare, Medicaid, Marketplaces & Coverage –

  • On December 5, the Government Accountability Office (GAO) released a report on the 2023 Medicare Physician Fee Schedule, which assessed CMS’ compliance with procedural steps and stated that the final rule does not have the required 60-day delay in its effective date. Report
  • On December 6, CMS issued a proposed rule on interoperability and prior authorization for Medicare Advantage organizations, state Medicaid and CHIP agencies and managed care entities, and Qualified Health Plan issuers on the Federally-facilitated Exchanges. The proposed rule also includes five requests for information (RFI). Comments are due by March 13, 2023. Press Release Fact Sheet Proposed Rule
  • Also on December 6, the HHS Office of Inspector General (OIG) released a report on Medicare Part B add-on tests, which found that certain labs billed Medicare Part B for questionably high levels of add-on tests alongside COVID-19 tests in 2020. Report
  • Also on December 6, Reps. Golden (D-ME), Turner (R-OH), Kildee (D-MI), and Spartz (R-IN) sent a letter urging congressional leadership to include a reauthorization of the Health Coverage Tax Credit in any end of year tax extenders legislation. Press Release Letter
  • On December 7, CMS announced that nearly 5.5 million people have selected an ACA Marketplace plan since the start of the 2023 Open Enrollment Period. Press Release Fact Sheet
  • Also on December 7, CMS released a notice with request for comment, acknowledging the receipt of an application from the Center for Improvement in Healthcare Quality for initial recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs. Notice
  • Also on December 7, the Congressional Budget Office (CBO) released a report,
    Options for Reducing the Deficit, 2023 to 2032,” which includes two volumes containing proposed options such as changes to Medicare Advantage benchmarks, changes to the cost-sharing rules for Medicare, restricting Medigap insurance, and reducing Medicare’s coverage of bad debt. Volume I Volume II
  • On December 8, CMS announced that the comment period for New Hampshire’s application to extend the state’s Substance Use Disorder, Serious Mental Illness, and Serious Emotional Disturbance Treatment Recovery and Access section 1115 demonstration is open from December 8, 2022 to January 6, 2023. Pending Application Comments
  • On December 9, a bipartisan group of 14 Senators sent a letter to HHS Secretary Becerra and CMS Administrator Brooks-LaSure urging CMS to update its national coverage determination, which limits Medicare coverage of certain brain imaging, to improve equitable access for people managing Alzheimer’s disease and other dementias. Letter

Payment & Delivery System Models –

  • On December 5, CMS released the evaluation report for the first year of the Primary Care First (PCF) model, which found that practices’ care delivery changes were largely enhancements of existing activities and that PCF payments were about 20 percent higher than participating practices would have otherwise received. Two Pager At-A-Glance Report Evaluation Report
  • On December 8, the Department of Defense released the notice of demonstration for the National Defense Authorization Act for Fiscal Year 2023, which authorizes a three-year ACO demonstration for TRICARE. The demonstration would test whether value-driven incentives can reduce health care spending and improve health care quality for TRICARE beneficiaries in Atlanta. The bill passed the House on December 8.  Bill Text Notice
  • Also on December 8, Sens. Warren (D-MA), Sanders (I-VT), and Booker (D-NJ), and 18 House Democrats, sent a letter to CMS Administrator Brooks-LaSure requesting CMS examine the participants in the ACO REACH model and take action to prevent those with histories of fraud and abuse from participating in the model. Letter Press Release

Public Health Prevention, Surveillance, & Data – 

  • COVID-19 Data: To date, there are 99,241,649 total COVID-19 cases and 1,080,472 COVID-19 deaths in the United States. Also, 926,257,435  COVID-19 vaccines have been delivered and 657,927,289 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 440 tests under Emergency Use Authorizations (EUAs), including 298 molecular tests, 86 antibody tests, 55 antigen tests, and 1 diagnostic breath test. FDA also continues to update COVID-19 FAQs.
  • On December 8, FDA amended emergency use authorizations (EUAs) of updated Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children as young as six months of age. Press Release
  • Also on December 8, Senate Homeland Security and Governmental Affairs Committee Chair Peters (D-MI) released a new report detailing findings of a two-year investigation into the federal government’s initial response to COVID-19 from 2019 through March 2020. Press Release Report 
  • On December 9, CDC released a report finding that people who received one or two doses of the Jynneos mpox vaccine contracted the infection at lower rates compared to unvaccinated people. Press Release Report
  • Also on December 9, CDC announced that it expanded the use of updated (bivalent) COVID-19 vaccines for children ages six months through five years of age. Press Release
  • Also on December 9, the Select Subcommittee on the Coronavirus Crisis released its final report, culminating over two years of investigations related to the nation’s coronavirus response. Press Release Report

Health IT, Privacy, & Digital Health –

  • On December 5, the Sequoia Project, the Recognized Coordinating Entity by the Office of the National Coordinator for Health IT (ONC) to support the Trusted Exchange Framework and Common Agreement (TEFCA), released the draft QHIN, Participant, and Subparticipant Additional Security Requirements Standard Operating Procedure (SOP). Announcement SOP
  • On December 7, the Federal Trade Commission (FTC), in conjunction with ONC and FDA, released an updated Mobile Health App Interactive Tool to help industry members determine what federal laws and regulations might apply to their apps. Press Release Tool
  • On December 8, House Energy & Commerce Committee Chair Pallone (D-NJ) and Ranking Member McMorris Rodgers (R-WA) sat down for an interview to discuss the importance of passing the American Data Privacy and Protection Act. Press Release Blog

Mental Health and Substance Use Disorder Policy –

  • On December 8, the White House Office of National Drug Control Policy (ONDCP) released the Non-Fatal Opioid Overdose Tracker to track non-fatal opioid overdose in the pre-hospital setting using nationally submitted Emergency Medical Services (EMS) data. Press Release Guide Tracker
  • Also on December 8, the Agency for Healthcare Research and Quality (AHRQ) released a report on racial and ethnic differences in emergency department visits related to substance use disorders in 2019. Report

Prescription Drugs, Medical Devices, & Biomedical Research –

  • On December 5, the FDA issued an update to a previous letter to health care providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP System manufactured by Abiomed. Press Release
  • Also on December 5, HHS released a report on the types and characteristics of medical device shortages in the US between the years 2006-2020. Report in Brief Report
  • On December 6, the FDA announced the availability of a final guidance entitled “Homeopathic Drug Products.” The guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products. Notice of Availability 
  • Also on December 6, the FDA released an updated version of the January 2022 safety communication on the use of Endologix AFX endovascular grafts used to treat patients with abdominal aortic aneurysm (AAA). Press Release
  • Also on December 6, Sen. Warren (D-MA) and Rep. Jayapal (D-WA) sent a letter to United States Patent and Trademark Office (USPTO) Director Kathi Vidal, following up on their June 2021 letter about the USPTO’s efforts to hold pharmaceutical companies accountable for anti-competitive business practices and tackle high drug prices. Press Release Letter
  • On December 8, House Ways & Means Committee Chair Neal (D-MA) sent letters to six stakeholder organizations requesting information on the environmental impacts of pressurized metered dose inhalers and how the sector is transitioning to more environmentally-friendly products. Press Release Letter
  • Also on December 8, Senate Finance Committee Chair Wyden (D-OR) sent a letter with a final request to Amgen for voluntary compliance in providing information about efforts to avoid billions in taxes through profit-shifting to subsidiaries in Puerto Rico. Press Release Letter

Veterans Health and Military Health –

  • On December 6, the Department of Veterans Affairs (VA) OIG released a report on the results of an evaluation of the inpatient and outpatient settings of the Louisville VA Medical Center and associated outpatient clinics in Indiana and Kentucky. The VA OIG issued five recommendations.  Report in Brief Report
  • On December 7, the VA OIG released a report assessing the merits of a January 2022 hotline allegation concerning inappropriate edits to community care referrals at the Puget Sound VA Health Care System in Seattle, WA. The VA OIG did not make any recommendations for corrective actions. Report in Brief Report
  • Also on December 7, the VA OIG released a report on the VA’s financial statements for fiscal years 2021 and 2022. Report in Brief Report
  • On December 8, the VA announced its intent to conduct a study to determine the most effective screening technique for liver cancer. The study, known as PREventing Liver Cancer Mortality through Imaging with Ultrasound vs. MRI (PREMIUM), will determine whether screening with abbreviated magnetic resonance imaging is better than ultrasound. Press Release
  • Also on December 8, the VA OIG released a report that found the Veterans Health Administration (VHA) and Medicare program made duplicate claim payments for community care services that were authorized by VHA. Report in Brief Report
  • Also on December 8, the VA OIG released a report outlining concerns with decision-making among Veterans Benefits Administration (VBA) leaders on issues that adversely affect some veterans and beneficiaries. Report in Brief Report
  • Also on December 8, the VA OIG released a report which found that the VBA’s Compensation Service did not fully accommodate veterans with visual impairments. Report in Brief Report
  • On December 9, the VA launched PACT Act Week of Action to inform Veterans, their families, and survivors about the PACT Act and encourage them to apply for health care and benefits. Press Release

Health Systems, Public Health, & Health Equity –

  • On December 5, CMS released a new training video to educate the public about their rights under the Emergency Medical Treatment and Labor Act (EMTALA). Training
  • Also on December 5, Sens. Shaheen (D-NH) and Hassan (D-NH) and Reps. Kuster (D-NH) and Pappas (D-NH) sent a letter to HHS Secretary Becerra urging HHS to support sexual education providers following the New Hampshire Executive Council’s decision to block their funding. Press Release Letter
  • Also on December 5, AHRQ released a blog post, “We Must Not Underestimate the Impacts of Gun Violence on Healthcare Workers.” Blog
  • On December 6, AHRQ released a report on hospital stays among children and adolescents in 2019. Report
  • Also on December 6, AHRQ released a report on changes in hospitalizations and in-hospital deaths from April-December 2020 in 38 states and DC. Report
  • Also on December 6, the FDA released findings from an external evaluation of the FDA’s Human Foods Program. Press Release Evaluation
  • On December 6 and 7, the White House hosted a series of meetings focused on how state legislators can advance policies in their upcoming legislative sessions, including lowering costs, expanding access to health care and housing, and supporting reproductive rights, gender equity, and LGBTQI+ equality. Meeting Readout
  • On December 7, CDC released a report on changes in twin births from 2019 to 2021. Report
  • Also on December 7, the HHS OIG released a report on the FDA’s approach to overseeing online tobacco retailers, concluding that improved oversight is needed to prevent youth tobacco use. Report
  • On December 8, CDC released a report on the characteristics of residents in residential care communities. Report
  • Also on December 8, CDC released updated guidance to state, tribal, local, and territorial public health agencies, and other partners on patterns of disease in communities, including cancer, and environmental concerns. Press Release Guidance
  • Also on December 8, the White House Office of Science and Technology Policy (OSTP) released a press release detailing progress from the Cancer Cabinet and private sector during the Cancer Moonshot week of action. Press Release
  • On December 9, AHRQ released a RFI on the development of a National Healthcare System Action Alliance to Advance Patient Safety. Comments are due by January 26, 2023. RFI
  • Also on December 9, AHRQ released a RFI seeking scientific information to inform the review on “Healthcare System Level Strategies to Address Racial/Ethnic and Related Disparities in Health and Healthcare,” which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Comments are due by January 11, 2023. RFI

Reproductive & Maternal Health  –

  • On December 2, HHS launched a new “Hear Her” campaign to improve American Indian and Alaska Native maternal health outcomes by raising awareness of life-threatening warning signs during and after pregnancy and improving communication between health care providers and their patients. Press Release

Misc. –

  • On December 5, the HHS OIG released a Semiannual Report to Congress identifying significant risks, problems, abuses, deficiencies, remedies, and investigative outcomes relating to the administration of HHS programs and operations that were disclosed during the semiannual reporting period April 1, 2022 – September 30, 2022. Press Release Report
  • On December 7, HHS issued a RFI to solicit public input on a proposed revised framework for evaluating a scoring peer review criteria for National Institutes of Health (NIH) research project grant applications. RFI
  • Also on December 7, House Energy & Commerce Committee Chair Pallone (D-NJ) and Senate HELP Committee Chair Murray (D-WA) sent a letter expressing their support for the Biden Administration’s implementation of key provisions of the No Surprises Act. Letter Press Release
  • On December 9, the Department of Justice and HHS OIG signed a memorandum of understanding (MOU) to strengthen the partnership between the two agencies and better protect and promote competition in health care markets. MOU

Legislative Activity –

Votes and Committee Activity –

  • On December 5, the Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act (H.R. 1193) passed the House by a voice vote. The bill would increase education, awareness, or diagnosis of valvular heart disease (VHD), and reduce cardiac deaths caused by the disease, including publishing best practices for physicians and health care providers who provide care to individuals with VHD. The bill now heads to the President to sign into law. Press release
  • On December 6, the Data Mapping to Save Moms’ Lives Act (S. 198) passed the House by a vote of 380-46. The bill would require the Federal Communications Commission to incorporate data on maternal health outcomes into its broadband health maps. The bill now heads to the President to sign into law. Bill text House Energy & Commerce Committee Press Release House Energy & Commerce Committee GOP Press Release
  • Also on December 6, the Rural Opioid Abuse Prevention Act (S. 2796) passed the House by a vote of 408-11. The bill would provide for the eligibility of rural community response pilot programs for funding under the Comprehensive Opioid Abuse Grant Program. The bill now heads to the President to sign into law. Bill text Press release
  • Also on December 6, the Early Hearing Detection and Intervention Act of 2022 (S. 4052) passed the House by a vote of 408-17. The bill would reauthorize a program for early detection, diagnosis, and treatment regarding deaf and hard-of-hearing newborns, infants, and young children. The bill now heads to the President to sign into law. Bill text Press release
  • Also on December 6, the Patents for Humanity Act of 2022 (H.R. 5796) passed the House by a vote of 396-24. The bill would establish a competition to award certificates that can be redeemed to accelerate certain matters at the Patent and Trademark Office. The bill now heads to the President to sign into law.  Bill text
  • On December 8, the James M. Inhofe National Defense Authorization Act (NDAA) for Fiscal Year 2023 (H.R. 7776) passed the House. The NDAA included key health care provisions, such as the Fighting Emerging Narcotics through Additional Nations to Yield Lasting (FENTANYL) Results Act, which would increase global cooperation in the fight against synthetic drug trafficking, among other provisions. The bill now heads to the President to sign into law. Bill text Press release
  • Also on December 8, the Disaster Assistance for Rural Communities Act (S. 1617) passed the House by a vote of 406-8. The bill would modify the requirements for the Administrator of the Small Business Administration relating to declaring a disaster in a rural area. The bill now heads to the President to sign into law. Bill text Press release

Introduced Legislation –

  • On December 5, Rep. Castor (D-FL) introduced the Creating Access to Residency Education Act of 2022 (H.R. 9424), which would authorize grants for graduate medical education partnerships in States with a low ratio of medical residents relative to the general population. Bill text
  • Also on December 5, Reps. Joyce (R-PA), O’Halleran (D-AZ), Panetta (D-CA), and Dunn (R-FL) introduced the Sustainable Cardiopulmonary Rehabilitation Services in the Home Act (H.R. 9427), which would permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to COVID-19. Press release
  • Also on December 5, Sens. Tester (D-MT) and Moran (R-KS) introduced the American Indian and Alaska Native Veterans Mental Health Act (S. 5181), which would make certain improvements relating to mental health and suicide prevention outreach to minority veterans and American Indian and Alaska Native veterans. Bill text Press release
  • On December 7, Sen. Gillibrand (D-NY) introduced the Helen Keller National Center Reauthorization Act of 2022 (S. 5201), which would reauthorize the Helen Keller National Center for Youths and Adults Who Are Deaf-Blind. Bill text
  • On December 8, Rep. Kirkpatrick (D-AZ) and 13 cosponsors introduced the Teacher and Educator Access to Crucial Health and Wellness (TEACH) Act (H.R. 9475), which would conduct a study on the impact of COVID-19 on the mental health of education professionals, to direct the Secretary of Education to award grants to implement or improve health and wellness programs for education professionals. Bill text Press release
  • Also on December 8, Sen. Shaheen (D-NH) and six cosponsors introduced the No Tax Subsidies for E-Cigarette and Tobacco Ads Act (S. 5213), which would deny the deduction for advertising and promotional expenses for tobacco products and electronic nicotine delivery systems. Bill text Press release
  • Also on December 8, Sen. Baldwin (D-WI) and ten cosponsors introduced the Reproductive Health Travel Fund Act (S. 5227), which would authorize grants to eligible entities to pay for travel-related expenses and logistical support for individuals with respect to accessing abortion services. Bill text Press release One pager