Health Care Policy Update – Weekly Wrap-Up and What’s Ahead – October 11, 2022


Notable Policy Events – 

  • Tuesday, October 11
    • CMS, “Encore Presentation: Navigating Performance Feedback Reports: Interim Performance Report (IPR) and Annual Performance Report (APR).” Additional information
    • AcademyHealth, “Turning Data into Digital Tools with the 2022 Health Equity DataJam Winners.” Additional information
    • Kaiser Health News, “The Long Shadow of Covid: Older People and the Ongoing Pandemic.” Additional information
    • Center for Health Care Strategies, “Involving Community Partners in Data and Policy Initiatives to Advance Health Equity.” Additional information
  • Wednesday, October 12
    • CMS, “DLTSS Training Series: Using Data to Inform and Improve 1915(c) Incident Management Systems.” Additional information
    • Social Interventions Research & Evaluation Network (SIREN), “Racial Health Equity in Social Care.”  Additional information
    • Consumer Technology Association, “Health Data Privacy in the Digital Age.” Additional information
    • Urban Institute, “Launching Urban’s Disability Equity Policy Initiative: A Conversation on Including Disability in Research.” Additional information
    • U.S. News & World Report, “How Child Mental Health Impacts the Workforce.” Additional information
    • Alliance for Health Policy, “The State of HIV/AIDS Progress & Applying Lessons Learned to Current Public Health Emergencies.” Additional information
    • Fierce Healthcare, “Fierce Health Payer Forum: Spotlight on Medicare Advantage.” Additional information
  • Wednesday, October 12 – Thursday, October 13
Weekly Wrap-Up: Notable Health Care Developments from Last Week
Medicare, Medicaid & Marketplaces – 

  • On October 3, the HHS Office of Inspector General (OIG) released a report examining Unified Program Integrity Contractors (UPICs) for Medicare fee-for-service (FFS) and the Medicaid programs. HHS OIG found that program integrity work was much more prevalent in Medicare FFS compared to Medicaid and that UPICs faced several program integrity challenges in Medicaid, including data availability and quality, as well as state differences in policies and regulations. Report in Brief Report 
  • Also on October 3, HHS Secretary Becerra and CMS Administrator Brooks-LaSure issued statements on the implementation of Medicare Part B payment changes for certain biosimilars, one of the first Medicare provisions of the Inflation Reduction Act (IRA) to go into effect. Qualifying biosimilars will now temporarily be paid the average sales price (ASP) plus eight percent (rather than plus six percent) of the reference biological product’s ASP for a five year period. Press Release October 2022 Part B Drug Pricing File
  • Also on October 3, HHS OIG released a report with findings from an audit of a Medicare Advantage organization examining high-risk diagnosis codes, which found that most of the selected diagnosis codes submitted to CMS for risk adjustment did not comply with federal requirements. Report in Brief Report
  • On October 4, HHS OIG released a report with findings from an audit of a Medicare Advantage organization which focused on nine groups of high-risk diagnosis codes and found that most of the selected diagnosis codes submitted to CMS for risk adjustment did not comply with federal requirements. Report in Brief Report
  • On October 5, CMS released Frequently Asked Questions (FAQs) regarding how IRA will impact Medicare benefits and prescription drug coverage and prices, as well as an implementation timeline of provisions including Medicare Part B qualifying biosimilars, Part D drug rebates, and insulin cost-sharing. Press Release FAQs Timeline
  • Also on October 5, CMS published states’ CHIP Annual Reports for federal fiscal years 2020 and 2021. The reports describe a variety of topics including program changes, state enrollment and uninsurance data, state policies and operations, and CHIP program financing/budgets. Reports
  • Also on October 5, Rep. Brown (D-OH) led 27 members of Congress in a letter urging House and Senate leaders to take action to prevent detrimental cuts to Medicare that are scheduled to go into effect soon. Press Release Letter
  • On October 6, CMS released the 2023 Star Ratings for Medicare Advantage and Medicare Part D prescription drug plans to help people with Medicare compare plans ahead of Medicare Open Enrollment, which begins on October 15. Press Release Fact Sheet
  • On October 7, HHS OIG released a report on whether Texas claimed federal funds for Medicaid uncompensated care (UC) payments in accordance with applicable Federal and State requirements. Report Press Release

Payment & Delivery System Models –

  • On October 6, CMS released the Updated interim Report to Congress for the Medicare Intravenous Immune Globulin (IVIG) Demonstration. Report
Public Health Prevention, Surveillance & Data – 

  • On October 3, HHS Secretary Becerra amended the Public Readiness and Emergency Preparedness (PREP) Act declaration for smallpox medical countermeasures to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox, monkeypox virus, and other orthopoxviruses in a declared emergency. Press Release Amended Declaration
  • On October 6, HHS released a report on nursing home staffing and the COVID-19 pandemic. This study explored the impact of the pandemic on direct care staffing (CNAs, LPNs and RNs). Certified Nursing Assistants Issue Brief Research Brief Contract Staff Issue Brief
  • On October 7, HHS released a report on the COVID-19 vaccination program. The study found that the vaccination program, which has gotten over 90 percent of seniors fully vaccinated and over 70 percent of seniors a booster shot, is linked to more than 650,000 fewer COVID-19 hospitalizations and more than 300,000 fewer deaths among seniors and other Americans enrolled in Medicare. Press Release Report
Health IT, Privacy, & Digital Health –

  • On October 3, HHS announced two awards under the Leading Edge Acceleration Projects in Health Information Technology (LEAP in Health IT) funding opportunity. Press Release
  • On October 4, Sens. Warner (D-VA), Smith (D-MN), Klobuchar (D-MN), Baldwin (D-WI), Bennet (D-CO), Murphy (D-CT), Sanders (I-VT), and Booker (D-NJ) sent a letter to HHS and CMS leadership asking them to review and formally report on the adequacy of the Affordable Care Act’s Essential Health Benefits (EHBs). The letter expressed the need for a review of telehealth flexibilities and the impact that scaling back these service options will have on those who rely on telehealth capabilities for treatment. Letter Press Release
  • Also on October 4, the White House Office of Science and Technology Policy (OSTP) released the Blueprint for an AI Bill of Rights to help guide the design, development, and deployment of artificial intelligence (AI) and other automated systems so that they protect the rights of the American public. Press Release Blueprint
  • On October 5, CMS released a Request for Information (RFI) on establishing a National Directory of Healthcare Providers & Services (NDH) that could serve as a “centralized data hub” for health care provider, facility, and entity directory information nationwide. The RFI is seeking input on the current state of health care provider directories and steps that it could or should take to create an NDH. Comments are due by December 6. Press Release RFI
  • Also on October 5, the Office of the National Coordinator for Health IT (ONC) released the top three themes from ONC’s electronic health information (EHI) sharing workshop. During the workshop, participants explored technical approaches and lessons learned related to sharing EHI when and where it is needed, consistent with the information blocking regulations and other applicable laws. Press Release

Mental Health and Substance Use Disorder Policy –

  • On October 3, HHS announced awards of nearly $27 million to improve and expand mental health care for children. Press Release

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On October 3, FDA released the Medical Device User Fee Amendments of 2022 (MDUFA V), which amended the Federal Food, Drug, and Cosmetic Act to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2022, including De Novo classification requests. Final Guidance Press Release
  • On October 6, FDA published a blog on steps the agency is taking on clinical research regulations to harmonize human subject protection regulations with the HHS Common Rule to make clinical trials more efficient and improve information for potential participants. Press Release
  • On October 7, FDA approved Boostrix for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age. Press Release
  • Also on October 7, Rep. Carter (R-GA) published a report as part of an initiative to educate members of Congress and the public on the role of pharmacy benefit managers (PBMs) in driving up prescription drug costs. Press Release Report

Veterans Health and Military Health –

  • On October 1, the Department of Veterans Affairs (VA) announced that the Program of Comprehensive Assistance for Family Caregivers is expanding to include eligible Veterans and family caregivers of all eras. Press Release
  • On October 5, the VA published a Notice of Funding Opportunity (NOFO) for more than $11 million in legal services grants for Veterans experiencing or at risk of homelessness. Applications are due by December 30, 2022. Press Release NOFO

Health Systems, Public Health & Health Equity –

  • On October 3, CMS announced grantees for the Minority Research Grant Program (MRGP). Each grantee will receive $333,000 in funding to support their projects, which will examine public health disparities and increase health equity research capacities at minority-serving institutions. Press Release
  • Also on October 3, several members of Congress sent letters to HHS Secretary Becerra in support of the Biden Administration’s Nondiscrimination in Health Programs and Activities effectuates Section 1557 of the Affordable Care Act (Nondiscrimination) proposed rule, including House Energy & Commerce Committee Chair Pallone (D-NJ), House Ways & Means Committee Chair Neal (D-MA), and House Education & Labor Committee Chair Scott (D-VA);  Senate HELP Committee Chair Murray (D-WA), Senate Finance Committee Chair Wyden (D-OR), along with 16 other Senators; and Reps. Newman (D-IL), Jayapal (D-WA), and Wexton (D-VA), along with 35 other members of Congress. House Committee Press Release and Letter; Senate Committee Press Release and Letter; House Member Press Release and Letter
  • Also on October 3, HHS announced more than $4.8 million in grants to 10 organizations under its Community-Driven Approaches to Address Factors Contributing to Structural Racism in Public Health initiative. Press Release
  • Also on October 3, House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA) issued a statement against funding to EcoHealth Alliance after the National Institutes of Health (NIH) grants database indicated it has restored funding after suspending its grant for more than two years. Press Release
  • On October 4, the Administration for Community Living (ACL) announced a new grant to develop a National Transportation Accessibility Center (NTAC). This award seeks to expand access to transportation for people with disabilities and older adults by increasing awareness and adoption of transportation accessibility strategies, inclusive planning, and mobility on demand transportation systems. Press Release
  • On October 5, HHS released the Addressing Bias in Language (ABL) Workgroup of the HHS Evidence and Evaluation (E&E) Council, which describes principles for equitable communication within the context of program evaluation and other forms of evidence building. Report
  • Also on October 5, the Health Resources & Services Administration (HRSA) announced a grant opportunity, “Rural Health Network Development Planning Program,” to promote the planning and development of integrated health care networks. Applications are due by January 6, 2023. Grant
  • On October 6, HHS announced actions to improve meaningful communication with limited English proficient (LEP) individuals by relaunching its Language Access Steering Committee to support HHS’ implementation of language access obligations. Press Release
  • Also on October 6, CDC and FDA released a study on youth and e-cigarettes use in 2022. The study found that 2.55 million U.S. middle and high school students reported current (past 30-day) e-cigarette use in 2022. Press Release Study

Reproductive, Maternal & Infant Health –

  • On October 3, the U.S. Congress Joint Economic Committee (JEC) released an analysis finding that states with the most restrictive abortion laws have worse economic conditions for families. Report Press Release
  • On October 4, White House Gender Policy Council Director Klein sent a letter to the President’s Task Force on Reproductive Health Care Access detailing the state of reproductive health access 100 Days from the Supreme Court’s Decision in Dobbs. The letter also noted announcements made by the Administration to protect access to reproductive health care. Letter
  • Also on October 4, HHS announced more than $6 million for Title X Family Planning Research grants, Research-to-Practice Center grants, and Teenage Pregnancy Prevention Evaluation and Research grants as part of its work to protect and expand access to reproductive health care. Press Release
  • Also on October 4, HRSA announced a $25 million grant opportunity for HRSA-funded health centers to increase equitable access to maternal health care in underserved communities. Award recipients will develop and pilot innovative models of care delivery to improve health outcomes and address clinical and health-related social needs for patients at the highest risk of maternal morbidity and mortality. Applications are due by December 5, 2022. Grant Notice
  • Also on October 4, President Biden and Vice President Harris provided remarks at the second meeting of the Task Force on Reproductive Healthcare Access. Remarks
  • On October 5, Vice President Harris provided remarks on reproductive rights. Remarks
  • Also on October 5, President Biden announced the 26th Operation Fly Formula Mission to transport Nestlé Gerber Good Start Extensive HA formula from Netherlands to Newark, NJ. Press Release
  • On October 6, Senate HELP Committee Ranking Member Burr (R-NC) sent a letter to FDA Commissioner Califf condemning FDA’s inadequate internal review and continued failure to answer for its role in the infant formula shortage. Press Release Letter
  • Also on October 6, HHS announced that there were 11 Operation Fly Formula flights completed through the month of September importing more than 13.7 million eight-ounce bottle equivalents of infant formula to the United States. Press Release

Misc. –

  • On October 1, ACL announced it is accepting public comments for the 2022 National Strategy to Support Family Caregivers. Comments will be used to inform the ongoing work of two Congressionally mandated caregiving advisory councils, as well as to inform future updates to the strategy. Comments are due by December 1, 2022. Press Release Request for Comments
  • On October 3, CMS announced resources and flexibility to assist with the public health emergency (PHE) in South Carolina, including waivers for providers, disaster toolkit and support for Medicaid and CHIP agencies, and activating the Kidney Community Emergency Response (KCER) program. Press Release
  • Also on October 3, Monica Beragnolli began work as the 16th director of the National Cancer Institute. Press Release
  • On October 4, the Congressional Budget Office (CBO) released a report on policy approaches Congress could take to reduce the high prices private plans pay for hospital and physician services. Report

Legislative Activity –
Introduced Legislation –

  • On October 4, Reps. Buchanan (R-FL) and Barragan (D-CA) introduced the Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 9127), which would clarify the use of the national coverage determination process under the Medicare program. Press release
  • Also on October 4, Reps. Mullin (R-OK) and O’Halleran (D-AZ) introduced the State Offices of Rural Health Reauthorization Act of 2022 (H.R. 9137), which would reauthorize the State offices of rural health program. Bill text Press release
  • On October 6, Sens. Lee (R-UT), Lankford (R-OK), Lummis (R-WY), and Rubio (R-FL) introduced the Protecting Drug Innovation Act, which would repeal prescription drug control provisions of the Inflation Reduction Act. Bill text Press release
  • On October 7, Rep. Brown (D-OH) introduced the Supplemental Nutrition Assistance Program (SNAP) Access for Medically Vulnerable Children Act (H.R. 9144), which would allow households with children with chronic medical conditions to deduct allowable medical expenses incurred by such household member that exceeds $35 per month. Press release