What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, February 28
    • House Committee on Oversight and Accountability, Select Subcommittee on the Coronavirus Pandemic, “Preparing for the Future by Learning from the Past: Examining COVID Policy Decisions.” Additional information
  • Wednesday, March 1
    • House Energy & Commerce Committee, Innovation, Data, and Commerce Subcommittee, “Promoting U.S. Innovation and Individual Liberty Through a National Standard for Data Privacy.” Additional information
    • House Judiciary Committee, Subcommittee on Crime and Federal Government Surveillance, “The Fentanyl Crisis in America: Inaction is No Longer an Option.” Additional information
  • Thursday, March 2

Notable Policy Events –

  • Monday, February 27 to Tuesday, February 28
    • CDC Foundation, “CDC and Office of the National Coordinator for Health Information Technology (ONC) Industry Days.” Additional information
    • National Academies of Science, Engineering, and Medicine, “Improving the Health and Wellbeing of Children and Youth through Health Care System Transformation Committee Meeting 1.” Additional information
  • Monday, February 27
    • R Street, “Opioid Harm Reduction 201: The Rise of Fentanyl and What It Means for Harm Reduction.” Additional information
    • White House, “Briefing on the National Strategy on Gender Equity and Equality Progress Report.” Additional information
  • Tuesday, February 28
    • Agency for Healthcare Research and Quality (AHRQ), “Leveraging Digital Health Technologies to Address the Needs of Underserved Populations.” Additional information
    • The Hill, “Rare Disease Day:  A Look at 40 Years of the Orphan Drug Act.” Additional information
  • Wednesday, March 1 to Thursday, March 2
    • Physician-Focused Payment Model Technical Advisory Committee (PTAC), “March Public Meeting.” Additional information
  • Wednesday, March 1
    • HHS Office on Women’s Health, “Eating Disorder Diagnosis and Referral in the Primary Care Setting.” Additional information
  • Thursday, March 2 to Friday, March 3
    • AHRQ and the National Institute on Minority Health and Health Disparities, “Impacts of Healthcare Algorithms on Racial and Ethnic Healthcare Disparities.” Additional information
    • Medicare Payment Advisory Commission (MedPAC), “March Public Meeting.” Additional information
  • Thursday, March 2
    • Center for American Progress, “The Next Wave of Technology Regulation: The Need for New Authorities in the U.S. and Beyond.” Additional information
    • Medicaid and CHIP Payment and Access Commission (MACPAC), “March Public Meeting.” Additional information
  • Friday, March 3
    • Alliance for Health Policy, “Moving Beyond COVID-19: Considerations for using PHE Flexibilities to Improve Person-Centered Care.” Additional information

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

Medicare & Medicaid –

  • On February 21, CMS released a slide deck on Medicaid and CHIP disability and language access requirements, which includes a spotlight on accessibility during the public health emergency (PHE) unwinding period. Slide Deck
  • On February 22, CMS released a statement that it is not reconsidering the national coverage determination for FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. Statement
  • On February 23, CMS released a data snapshot providing information on COVID-19 related service utilization by beneficiaries for services through July 2022. Data Snapshot
  • Also on February 23, House Ways & Means Committee Chair Smith (R-MO), Senate Finance Committee Ranking Member Crapo (R-ID), and House Energy & Commerce Committee Chair Rodgers (R-WA) sent a letter to HHS Secretary Becerra and CMS Administrator Brooks-LaSure, raising questions regarding how the Administration will use the $3 billion in funds allocated in the Inflation Reduction Act to implement the Medicare drug price negotiation program. Press Release Letter
  • Also on February 23, CMS released updated guidance for ground ambulance providers and suppliers utilizing the public health emergency 1135 waivers. Guidance
  • Also on February 23, CMS released new quality improvement resources from the Improving Asthma Control Affinity Group as part of its efforts to offer quality improvement technical assistance to help states improve asthma control for people in the Medicaid and CHIP programs. Resources
  • On February 24, CMS issued a proposed rule to provide states and hospitals more clarity on how Medicaid disproportionate share hospital (DSH) payments will be calculated given recent legislative changes, and to make technical changes and clarifications to the DSH program. Comments are due April 25, 2023. Proposed Rule
  • Also on February 24, CMS released a notice announcing its decision to approve the Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs. Notice
  • Also on February 24, House Energy & Commerce Committee Chair Rodgers (R-WA) and House Ways & Means Committee Chair Smith (R-MO) issued a statement on the Administration’s decision to limit Medicare coverage for novel drugs to treat Alzheimer’s disease. Statement
  • Also on February 24, the HHS Office of Inspector General (OIG) published a report that found Florida improperly made Medicaid managed care capitation payments in August 2020 totaling $15.8 million for enrollees who were concurrently enrolled in Medicaid benefits in another state. Report in Brief Report

Marketplaces & Insurance Coverage –

  • On February 21, CMS released the Draft Call Letter for the Quality Rating System (QRS) and the Qualified Health Plan (QHP) Enrollee Experience Survey, which communicates proposed changes to the QRS and QHP Enrollee Survey. CMS is requesting comments on these proposed refinements by March 22, 2023. Draft Call Letter
  • On February 22, Sens. Baldwin (D-WI) and Murphy (D-CT) led a group of 32 Senators in a letter to HHS Secretary Becerra urging action to limit the availability of short-term limited duration insurance (STLDI) plans. Press Release Letter
  • On February 24, the Internal Revenue Service (IRS), Employee Benefits Security Administration, and Pension Benefit Guaranty Corporation released the final forms and instructions revisions for the Form 5500 Annual Return/Report of Employee Benefit Plan and Form 5500-SF Short Form Annual Return/Report of Small Employee Benefit Plan, which affect employee pension and welfare benefit plans, plan sponsors, administrators, and service providers to plans subject to annual reporting requirements. Final Forms Revisions

Payment & Delivery System Models – 

  • On February 22, CMS announced it is accepting applications from Medicare-enrolled providers, suppliers, and Medicare Accountable Care Organizations (ACOs) to participate in the forthcoming two-year extension of the Bundled Payments for Care Improvement (BPCI) Advanced Model. The application deadline is May 31, 2023. BPCI Advanced Model Fact Sheet Applicant Resources
  • On February 23, CMS released the final Calendar Year (CY) 2023 Monitoring Guidelines for the Medicare Advantage (MA) Value-Based Insurance Design (VBID) Model, which outlines the reporting domains and requirements for MA Organizations participating in the VBID Model in CY 2023. Guidelines

Public Health Preparedness, Prevention, Surveillance, & Data – 

  • COVID-19 Data: To date, there are 103,268,408 total COVID-19 cases and 1,115,637 COVID-19 deaths in the United States. Also, 963,131,415 COVID-19 vaccines have been delivered and 671,582,379 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 443 tests under Emergency Use Authorizations (EUAs), including 298 molecular tests, 84 antibody tests and 60 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On February 23, CMS published updated guidance for providers on how Medicare, Medicaid, CHIP, and Marketplace program 1135 waivers and flexibilities will be affected at the conclusion of the PHE. Updates
  • Also on February 23, Senate Finance Committee Chair Wyden (D-OR) and Senate Special Committee on Aging Chair Casey (D-PA) released an investigative report examining emergency preparedness in long-term care facilities during the February 2021 winter storm in Texas. The report’s recommendations call for developing more inclusive disaster planning and management and improving transparency related to nursing home emergency preparedness plans. Press Release Report
  • On February 24, the Health Resources and Services Administration (HRSA) released a notice publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP). Notice
  • Also on February 24, the FDA issued an emergency use authorization for the first over-the-counter at-home diagnostic test to differentiate and detect the flu and COVID-19. Press Release

Health IT, Privacy, & Digital Health –

  • On February 21, the HRSA Office for Advancement of Telehealth released a fact sheet on health equity in telehealth. Specifically, the resource provides best practices on how telehealth can improve health care for underserved patients. Fact Sheet
  • Also on February 21, the National Institutes of Health’s (NIH) All of Us Research Program published a research opportunity announcement (ROA) to establish the Center for Linkage and Acquisition of Data (CLAD). This platform will securely acquire, process, and link new types of information to All of Us program participant data. Proposals are due April 17, 2023. Press Release ROA
  • Also on February 21, ONC announced that the public comment period for the 2023 Standards Version Advancement Process (SVAP) is now open. Comments will be accepted until May 22, 2023. Blog
  • On February 22, ONC announced a new Social Determinants of Health (SDOH) Information Exchange Toolkit. This resource is designed to aid the health IT community in the implementation of initiatives that recognize the importance of using SDOH information. Blog Toolkit
  • Also on February 22, HHS OIG released a report that assessed the effectiveness of HRSA’s cybersecurity defenses. HHS OIG found that HRSA’s cybersecurity controls needed improvements to better detect and prevent cyber threats on its network. Report in Brief Report
  • Also on February 22, Senate Special Committee on Aging Chair Casey (D-PA) released a statement asking the Department of Justice (DOJ) and entire federal government to prioritize technology and web accessibility and transparency for individuals with disabilities, following the DOJ release of data for the first time in a decade on the accessibility of federal government technology. Press Release Data
  • On February 24, HRSA released a notice requesting an extension to continue using the same performance measures to evaluate the effectiveness of the Telehealth Network Grant Program services and monitor its progress. Notice

Mental Health and Substance Use Disorder Policy –

  • On February 23, the Substance Abuse and Mental Health Services Administration (SAMHSA) released an advisory, which focuses on the risks and harms of cannabidiol. Advisory
  • Also on February 23, SAMHSA released a report on the Optimizing Recovery Funding project. The project aims to identify and recommend best practices and strategies to optimize funding for high quality and effective recovery support services. Report
  • On February 24, the Biden Administration published a proclamation taking action to address eating disorders and mental health. Press Release
  • Also on February 24, the White House Office of National Drug Control Policy (ONDCP) published a press release outlining takeaways from ONDCP Director Gupta’s recent meeting with public health leaders and law enforcement officials in New Jersey on expanding access to addiction treatment in jails and prisons. Press Release
  • Also on February 24, the Drug Enforcement Administration (DEA) issued two proposed rules outlining specifications for the prescribing of controlled medications via telemedicine. The proposed rules would allow medical providers to prescribe a 30-day supply of Schedule III-IV non-narcotic controlled substances or a 30-day supply of buprenorphine to treat opioid use disorder prior to a requirement for an in-person evaluation or referral. Comments are due 30 days after publication in the Federal Register. Press Release Buprenorphine Proposed Rule Telemedicine Prescribing of Controlled Substances Proposed Rule

Prescription Drugs, Medical Devices, & Biomedical Research –

  • On February 21, the FDA announced the availability of draft guidance that provides recommendations on product-specific guidance meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted an abbreviated new drug application (ANDA). Notice Draft Guidance
  • On February 23, the FDA published a blog on the agency’s efforts to advance medical products for patients with rare diseases, including the announcement of FDA’s Rare Disease Day on Monday, February 27. Blog
  • Also on February 23, the FDA released a letter to health care providers about the potential for exposure to airborne chemicals that may be released from neonatal incubators. Letter
  • On February 24, the FDA announced the availability of draft guidance that provides recommendations to sponsors developing drugs intended to treat neovascular age-related macular degeneration. Notice Draft Guidance
  • Also on February 24, FDA Commissioner Califf published a blog on the agency’s efforts in 2022 across several workstreams, including: supply chain; diagnostic testing; dietary supplements; FDA advisory committees; chronic diseases, including mental health; interagency collaboration; data science and statistics; genome modification; substance use disorder and associated overdose deaths; and cannabis and its over 30 derivatives. Blog

Veterans Health and Military Health –

  • On February 22, the Department of Veterans Affairs (VA) OIG released a report on police staffing shortages and growing concerns about incidents at VA facilities. VA OIG visited 70 VA medical facilities and identified multiple security vulnerabilities and deficiencies at these facilities. Report in Brief Report
  • Also on February 22, the VA finalized an interim final rule that amended its medical regulations concerning payment or reimbursement for emergency treatment for non-service-connected conditions at non-VA facilities. The final rule will be effective April 24, 2023. Final Rule
  • On February 23, VA OIG released a report on an audit that was conducted and identified issues with staff background checks for the Beckley VA Medical Center in West Virginia. Report in Brief Report
  • Also on February 23, the VA announced that veterans can now access their disability benefit claim decision notice letters electronically on VA.gov. Press Release
  • Also on February 23, the Government Accountability Office (GAO) released a report on a requirement that Veterans Health Administration (VHA) medical centers get a waiver before employing anyone with a controlled substance-related felony conviction whose job gives them access to such substances. GAO recommended VHA implement a policy regarding these employment waivers to protect veterans. Report in Brief Report
  • On February 24, the VA announced the availability of nearly $16 million in grants to qualifying organizations to help veterans and service members with disabilities participate in adaptive sports. Press Release
  • Also on February 24, GAO released a report that describes the VHA’s expedited onboarding process for clinical staff and examines the data VHA uses to oversee the expedited onboarding. GAO found that VHA lacks reliable onboarding data for new clinical staff. Report in Brief Report

Population Health, Public Health & Health Equity –

  • On February 21, AHRQ released a blog post, “For American Heart Month, AHRQ Offers New Tools for Expanding Cardiac Rehabilitation,” sharing newly available online training materials to improve the use of cardiac rehabilitation. Blog Post
  • On February 22, HHS released a notice with its Semiannual Regulatory Agenda, which contains an inventory of expected rulemaking in development aimed at expanding access to health care, tackling disparities and advancing equity, and supporting the wellbeing of families and communities, among other policy priorities. Notice
  • Also on February 22, the FDA announced it filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization. Press Release BAM Group LLC CMP Great American Vapes LLC CMP The Vapor Corner Inc. CMP 13 Vapor Co. LLC CMP
  • On February 23, the FDA released a blog post, “What FDA’s Foods Program Achieved in 2022 to Protect Consumers and the Food Supply.” Blog Post
  • Also on February 23, HHS published the 2023 Health Equity DataJam challenge and webpage, which invites teams to leverage data from healthdata.gov and other publicly available datasets to propose solutions at the juncture of health equity and the social determinants of health. Submissions are due by April 30, 2023. Challenge Application
  • On February 24, HHS released a notice announcing the availability of the draft Physical Activity Guidelines Midcourse Report on Older Adults. Comments on the draft report are due by March 10, 2023. Notice
  • Also on February 24, the FDA’s Center for Tobacco Products (CTP) outlined the steps it plans to take to strengthen the agency’s Tobacco Program. Press Release Actions

Health Systems & Health Care Workforce –

  • On February 22, Senate Finance Committee Chair Wyden (D-OR) and Sen. Warren (D-MA) sent a letter to a consulting firm raising questions about its role in helping nonprofit hospitals collect money from low-income patients. Press Release Letter
  • On February 23, HRSA Administrator Carole Johnson and House Energy & Commerce Committee Chair Rodgers (R-WA) visited the Spokane Teaching Health Center to highlight the role of the Teaching Health Center Graduate Medical Education (THCGME) program in bringing health care providers to communities that need them most by training directly in the community. Press Release
  • Also on February 23, Senate Finance Committee Chair Wyden (D-OR) and Sens. Merkley (D-OR) and Booker (D-NJ) sent a letter to Attorney General Merrick Garland, Assistant Attorney General Kristen Clark, and Disability Rights Section Chief Rebecca Bond urging investigations of offenses under the American Disabilities Act to include the practices of state medical license boards. Press Release Letter
  • On February 24, HRSA released a notice on information collected by the THCGME program recipients. Comments are due by March 26, 2023. Notice

Reproductive & Maternal Health  –

  • On February 21, the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation statement, recommending that anyone who is planning to or could become pregnant take a daily supplement containing 0.4 to 0.8 mg of folic acid. Draft Recommendation
  • Also on February 21, the U.S. Department of Agriculture (USDA) announced adjusted income eligibility guidelines to be used by State agencies in determining the income eligibility of persons applying to participate in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Notice
  • On February 23, the USDA issued a proposed rule to remove barriers to online ordering and internet-based transactions in the WIC program. Comments are due by May 24, 2023. Proposed Rule

Misc. –

Legislative Activity –

Introduced Legislation –

  • On February 21, Reps. Balderson (R-OH), Lee (D-NV), Hinson (R-IA), and Neguse (D-CO) introduced the Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act (H.R. 1110), which would direct the Secretary of HHS, MedPAC, and MACPAC to conduct studies and report to Congress on actions taken to expand access to telehealth services under the Medicare, Medicaid, and CHIP programs during the COVID-19 emergency. Press release
  • Also on February 21, Rep. Bera (D-CA) introduced the Easy Enrollment in Health Care Act (H.R. 1113), which would streamline enrollment in health insurance affordability programs and minimum essential coverage. Bill text Press release
  • Also on February 21, Reps. Castor (D-FL), Fitzpatrick (R-PA), and Underwood (D-IL) introduced the Advancing Safe Medications for Moms and Babies Act of 2023 (H.R. 1117), which would implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research. Bill text Press release Section-by-section
  • Also on February 21, Reps. Pfluger (R-TX), Smith (R-NJ), Alford (R-MO), and Steube (R-FL) introduced the Prohibiting Federal Emergencies for Abortion Act (H.R. 1143), which would prohibit the declaration of a Federal emergency relating to abortion. Bill text Press release
  • On February 24, Reps. Arrington (R-TX), Panetta (D-CA), and Hern (R-OK) introduced the Access to Future Cures Act (H.R. 1170), which would clarify that expenses for blood storage qualify as expenses for medical care. Press release
  • Also on February 24, Rep. Vargas (D-CA) introduced the Public Health Emergency Medical Supplies Enhancement Act of 2023 (H.R. 1166), which would enhance authorities under the Defense Production Act of 1950 to respond to the public health emergencies and to provide additional oversight of such authorities. Bill text Press release

Also on February 24, Rep. McHenry (R-NC) introduced the Data Privacy Act of 2023 (H.R. 1165), which would modernize the protection of the nonpublic personal information of individuals with whom financial institutions have customer or consumer relationship. Bill text