Health Care Policy Update – Weekly Wrap-up and What’s Ahead – November 7, 2022


Notable Policy Events –

  • Monday, November 7 – Wednesday, November 9
    • The Population Health Colloquium, “The Leading Forum on Population Health Innovations.” Additional information
  • Monday, November 7
    • American Enterprise Institute, “How Will the Inflation Reduction Act Affect the Cost of Medicines for Patients?” Additional information
    • NIHCM Foundation, “Health During and After Incarceration.” Additional information
    • Center for Medicare & Medicaid Innovation, “Interested Stakeholder Meeting.” Additional information
    • The Office of the National Coordinator for Health Information Technology (ONC), “Public Health Data Systems Task Force 2022.” Additional information
  • Tuesday, November 8
  • Wednesday, November 9
    • Mental Health Technology Transfer Center Network, “Medicaid and School Mental Health: A Guided Tour Through Available Resources.” Additional information
    • ONC, “Public Health Data Systems Task Force 2022.” Additional information
  • Wednesday, November 9 – Thursday, November 10
    • Health Care Payment Learning & Action Network (HCP LAN), “Accelerating Towards Action LAN Summit.”  Additional information
  • Thursday, November 10
    • ONC, “Health IT Advisory Committee (HITAC) Meeting.” Additional information
    • Center for Strategic & International Studies, “Report Launch: Transforming Health Crises with Pandemic Therapies.” Additional information

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

  • On October 31, CMS issued the calendar year (CY) 2023 Home Health Prospective Payment System (HH PPS) Rate Update Final Rule, which updates Medicare payment policies and rates for home health agencies (HHAs). Fact Sheet Final Rule
  • Also on October 31, CMS issued the CY 2023 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule, which updates the payment rates and policies under the ESRD PPS for renal dialysis services effective January 1, 2023. Fact Sheet Final Rule
  • Also on October 31, CMS launched the tenth year of Marketplace Open Enrollment, which runs from November 1, 2022, to January 15, 2023. Press Release
  • On November 1, CMS issued the CY 2023 Medicare Physician Fee Schedule (PFS) Final Rule which updates payment rates and finalizes policy changes for Medicare payments under the Physician Fee Schedule, and other Medicare Part B issues, effective January 1, 2023. Press Release Fact Sheet MSSP Fact Sheet Quality Payment Program Fact Sheet Blog on Behavioral Health Policies Final Rule
  • Also on November 1, CMS issued the CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System Final Rule, which updates payment rates and finalizes policy changes effective January 1, 2023. The final rule allows Critical Access Hospitals (CAHs) and small rural hospitals to convert to a Rural Emergency Hospital (REH) and pays hospital outpatient departments to provide remote behavioral health services to people at home. Press Release Fact Sheet New Provider Type Fact Sheet Final Rule
  • Also on November 1, CMS approved an amendment to Arkansas’ Medicaid section 1115 demonstration that will test interventions to address housing, food insecurity, and other health-related social needs. Press Release
  • Also on November 1, the White House issued a fact sheet claiming health care proposals put forward by congressional Republicans would result in coverage losses for Medicare, Medicaid, and Social Security beneficiaries and increased prescription drug prices. Fact Sheet
  • Also on November 1, Rep. Burgess (R-TX), House Budget Committee Ranking Member Smith (R-MO), and members of the Doctors Caucus sent a letter to House Budget Committee Chair Yarmuth (D-KY), expressing their concerns with the forthcoming sequester cuts to Medicare and urging a hearing on the statutory Pay-As-You-Go Act of 2010 (PAYGO) to prevent Medicare budget cuts in a fiscally responsible way. Press Release Letter
  • On November 2, CMS released an update to the Medicaid and CHIP COVID-19 data snapshot, which includes data on COVID-19-related service utilization by beneficiaries through April 2022. Data Snapshot
  • Also on November 2, a bipartisan group of 46 Senators signed a letter to Senate leadership expressing concerns regarding the stability of Medicare payments for physicians and support for bipartisan, long-term payment reform. Letter
  • Also on November 2, CMS opened the federal comment period for South Dakota’s application to extend the Former Foster Care Youth demonstration for a five-year period, which provides coverage for certain former foster care youth under age 26. Pending Application Comments
  • On November 3, Senate Finance Committee Chair Wyden (D-OR) released a report on deceptive marketing practices targeting seniors with Medicare Advantage plans. The Committee received evidence of fraudulent and misleading marketing practices from states and stakeholders. The report provides several recommendations to CMS that would reduce the prevalence of these tactics. Press Release Report

Payment & Delivery System Models –

Public Health Prevention, Surveillance & Data – 

  • COVID-19 Data: To date, there are 97,604,763 total COVID-19 cases and 1,068,667 COVID-19 deaths in the United States. Also, 928,460,585 COVID-19 vaccines have been delivered and 640,913,400 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 435 tests under Emergency Use Authorizations (EUAs), including 298 molecular tests, 85 antibody tests and 51 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On November 1, House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA), Subcommittee on Health Ranking Member Guthrie (R-KY), and Subcommittee on Oversight and Investigations Ranking Member Griffith (R-VA) sent a letter to the National Institutes of Health (NIH) Acting Director Tabak requesting information related to a National Institute of Allergy and Infectious Diseases (NIAID) monkeypox virus enhancement, which has reportedly made the disease 1,000 percent more lethal in mice. Press Release Letter
  • On November 2, HHS Secretary Becerra renewed the public health emergency (PHE) for monkeypox. Declaration
  • On November 3, HHS Office of Inspector General (OIG) released a report, which found that during the initial three months of the COVID-19 response, CDC’s personal protective equipment (PPE) trainings appear to have failed to meet two standards set by the Occupational Safety and Health Administration (OSHA). Report in Brief Report
  • Also on November 3, House Ways & Means Committee Ranking Member Brady (R-TX), along with Reps. Kelly (R-PA) and Smucker (R-PA), wrote a letter to HHS Secretary Becerra renewing calls for transparency and data on COVID-19-related nursing home deaths, particularly seeking summary reports provided to New York, Pennsylvania, Michigan, New Jersey, and California to determine if these states intentionally misled the public and federal government on COVID-19-related deaths in those facilities. Press Release Letter
  • On November 4, House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA), Subcommittee on Health Ranking Member Guthrie (R-KY), and Subcommittee on Oversight and Investigations Ranking Member Griffith (R-VA) sent a letter to CDC Director Walensky regarding faulty monkeypox diagnostic tests. Press Release Letter

Health IT, Privacy, & Digital Health –

  • On October 31, ONC published a blog on its recent coordination with the White House Office of Science & Technology Policy (OSTP) in the release of two Requests for Information (RFIs) seeking public input on data capture for clinical trials. Blog
  • Also on October 31, the Indian Health Service (IHS) announced the expansion of telehealth across IHS federal facilities to meet the needs of American Indian and Alaska Native patients. Using AA RingMD, the system protects personally identifiable information and protected health information for patients utilizing the telehealth service. Press Release
  • On November 3, Senate Select Committee on Intelligence Chair Warner (D-VA) published a policy options paper titled “Cybersecurity is Patient Safety,” which outlines the current cybersecurity threats facing health care providers and systems and offers for discussion a series of policy solutions to improve cybersecurity across the industry. Press Release Report

Mental Health and Substance Use Disorder Policy –

  • On November 3, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced CAPT Jennifer Fan as the Acting Director for the Center for Substance Abuse Prevention (CSAP). CAPT Fan will advise the Assistant Secretary on matters related to the substance use prevention policy and programs and serve as the primary contact within SAMHSA on all CSAP activities. Press Release
  • Also on November 3, CDC released updated and expanded recommendations for clinicians providing pain care for adult outpatients. These clinical recommendations, published in the CDC Clinical Practice Guideline for Prescribing Opioids for Pain, are intended to help clinicians work with patients to ensure safe and effective pain care is provided. Press Release Updated Recommendations

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On October 31, FDA issued a safety communication regarding a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. Safety Communication
  • On November 1, FDA released an executive summary from the meeting of the Anesthesiology Devices Advisory Committee. The Committee found that pulse oximeters used to measure blood oxygen saturation levels perform worse in people with darker skin tones. The Committee recommended that FDA should require higher clinical performance standards for their use. Executive Summary
  • On November 2, Rep. Porter (D-CA) released a report documenting how Big Pharma has continued to set high prices for new drugs. The report analyzes pricing and spending data to show how the prices of newly launched cancer drugs put patients and taxpayers at risk. Press Release Report
  • Also on November 2, Reps. Tonko (D-NY), LaHood (R-IL), Barragan (D-CA), and Upton (R-MI) sent a letter to HHS Secretary Becerra and CMS Administrator Brooks-LaSure calling for improved access to diagnostic tests able to detect Alzheimer’s disease. Press Release Letter
  • Also on November 2, Sen. Rubio (R-FL) and Reps. Balart (R-FL), Rutherford (R-FL), Bilirakis (R-FL), Dunn (R-FL), and Mast (R-FL) sent a letter to FDA Commissioner Califf requesting an update on Florida’s application to the FDA on approval for the Canadian Prescription Drug Importation Program within the Florida Agency for Health Care Administration (AHCA) to facilitate the commercial importation of certain prescription drugs into Florida from approved Canadian suppliers, and to expeditiously approve AHCA’s proposal. Press Release Letter
  • On November 3, House Committee on Oversight & Reform Chair Maloney (D-NY) released data on the Inflation Reduction Act and its impact on lowering prescription drug prices. Press Release Data
  • On November 4, HHS released a report on the potential impacts of select clinical strategies on the cost, duration, and phase transition probability associated with therapeutic complex medical device development stages. Report
  • Also on November 4, HHS released a report examining the potential impacts of select strategies on the cost, duration, and phase transition probability associated with drug, preventive vaccine, and therapeutic complex medical device development stages. Report

Veterans Health and Military Health –

  • On October 31, the Department of Veterans Affairs (VA) OIG released a report that assessed VA’s compliance with requirements to report staffing and vacancy data on its website. The review team found that VA could strengthen its explanation of vacant positions and increase the value of its reported information by summarizing and identifying trends in the expanded time-to-hire data. Report in Brief Report
  • On November 1, VA OIG released a report on the Care in the Community health care inspection program that examines clinical and administrative processes associated with providing quality outpatient health care to veterans. This report provides a focused evaluation of Veterans Integrated Service Network (VISN) 15 and its oversight of the quality of care delivered. Report in Brief Report
  • On November 3, VA OIG released a report on the Veteran Health Administration’s (VHA) progress in monitoring their follow up of canceled appointments during the COVID-19 pandemic and concluded that VHA can strengthen its oversight by monitoring follow up rates and reassessing what constitutes follow up activities. Report in Brief Report
  • Also on November 3, the VA announced preliminary results of the 2022 Point-in-Time Count showing an 11 percent decline in Veteran homelessness since early 2020, the last time a full count was conducted. Press Release Point-in-Time Count
  • On November 4, Reps. Welch (D-VT) and Soto (D-FL) led 17 House Members in a letter to Acting Assistant Secretary of Defense for Health Affairs Seileen Mullen, calling on the Department of Defense to ensure TRICARE beneficiaries can continue to receive medical care at local community pharmacies. Press Release Letter

Health Systems, Public Health & Health Equity –

  • On October 31, the Health Resources and Services Administration (HRSA) announced $8 million in funding to Meharry Medical College, a Historically Black College and University (HBCU), to improve and expand HIV care and treatment in Africa. Press Release
  • Also on October 31, Sen. Padilla (D-CA) and Rep. Lee (D-CA) sent a letter to HHS Secretary Becerra, urging him to declare a national public health emergency on gun violence. Press Release Letter
  • On November 1, HHS Secretary Becerra met with New York state advocates to discuss efforts to close equity gaps in health care, particularly through Medicaid. Press Release
  • On November 2, HHS announced $4.5 billion in assistance to help lower heating costs for American families this winter. The Low-Income Home Energy Assistance Program (LIHEAP) funds will go to states, territories, and tribes to subsidize home heating costs and help families make cost-effective home energy repairs. Press Release White House Fact Sheet
  • Also on November 2, HHS announced the three winners of the final phase of the HIV Challenge, a national competition to reduce HIV-related stigma and disparities. Press Release HIV Challenge
  • On November 6, the Biden Administration announced actions to advance equity and opportunity for African American families. Actions to advance health include dismantling barriers to United States Department of Agriculture (USDA) programs, lowering health care costs, diversifying the health care workforce, among others. Press Release

Reproductive, Maternal & Infant Health –

  • On November 1, Sens. Hirono (D-HI), Warren (D-MA) Duckworth (D-IL) and Smith (D-MN) released a report revealing the consequences of state abortion bans and restrictions. The report details the effects of these laws on women’s access to health care as described by health care organizations. Press Release Report
  • On November 2, the FDA provided an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s increased flexibilities. Press Release
  • On November 3, HRSA released an RFI on the two draft recommendations to update the HRSA-Supported Women’s Preventive Services Guidelines relating to Screening for Diabetes in Pregnancy and Screening for Type 2 Diabetes after Pregnancy. Comments are due by December 5, 2022. RFI

Legislative Activity –

Introduced Legislation –

  • On October 31, Reps. Trahan (D-MA), Carey (R-OH), Stewart (R-UT), and Porter (D-CA) introduced the Stop Online Suicide Assistance Forums Act (H.R. 9260), which would prohibit the use of mail or interstate communications to assist suicide. Bill text Press release
  • Also on October 31, Reps. Williams (D-GA), Jacobs (D-CA), Garcia (D-TX), Lee (D-CA), and Escobar (D-TX) introduced the HHS Reproductive and Sexual Health Ombuds Act of 2021 (H.R. 9254), which would establish within the Department of Health and Human Services an Ombuds for Reproductive and Sexual Health. Bill text Press release

On November 3, Reps. Schakowsky (D-IL), LaHood (R-IL), Quigley (D-IL), Hern (R-OK), Newman (D-IL), Roybal-Allard (D-CA), Casten (D-IL), Schneider (D-IL), and Bost (R-IL) introduced the Dr. Joanne Smith Memorial Rehabilitation Innovation Centers Act of 2022 (H.R. 9271), which would preserve access to rehabilitation innovation centers under the Medicare program. Press release