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What’s Ahead: This Week
Notable Policy Events –
- Tuesday, January 10
- American Enterprise Institute, “Accurate Race and Ethnic Representation in Pivotal Clinical Drug Trials: Why It Matters and Potential Approaches to Achieve It.” Additional information
- Health Affairs, “National Health Care Spending In 2021: Decline In Federal Spending Outweighs Greater Use Of Health Care.” Additional information
- Wednesday, January 11
- Office of the National Coordinator for Health IT (ONC), “Optimizing Data Capture for Clinical Trials, An OSTP/ONC Listening Session.” Additional information
- White House, “Health Community Engagement Call.” Additional Information
- Thursday, January 12 – Friday, January 13
- Thursday, January 12
- Friday, January 13
- University of Pennsylvania, Leonard Davis Institute of Health Economics, “Unpacking Consolidation in Health Care.” Additional information
Weekly Wrap-Up: Notable Health Care Developments from Last Week
Medicare –
- On January 3, the HHS Office of Inspector General (OIG) released a report which found that CMS has some oversight procedures in place to review average sales price data, but gaps exist that allow inaccurate data to impact Medicare Part B payment amounts. Report Report in Brief
- Also on January 3, HHS OIG released a report which identified a small number of inconsistencies in how average sales prices for Medicare Part B drugs are calculated and nine specific areas for which manufacturers believe additional CMS guidance may be needed. Report Report in Brief
- Also on January 3, CMS announced that it is accepting recommendations regarding potential new specialty measure sets and/or revisions to existing specialty measure sets for the 2024 performance year of the Merit-based Incentive Payment System (MIPS). Recommendations are due by February 13, 2023. Measure Specifications
- Also on January 3, President Biden announced the nomination of Demetrios L. Kouzoukas for Member of the Supplementary Medical Insurance Trust Fund Board of Trustees, the Federal Hospital Insurance Trust Fund Board of Trustees, and the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Board of Trustees. Announcement
- On January 6, HHS Secretary Becerra issued a notice delegating authority to the CMS Administrator to implement certain provisions of the Inflation Reduction Act pertaining to drug price negotiation and Medicare Part B and Part D inflation rebates. Notice
Medicaid –
- On January 3, the Government Accountability Office (GAO) released a notice requesting nominations for the Medicaid and CHIP Payment and Access Commission (MACPAC). Nominations are due by January 26, 2023 for MACPAC appointments effective May 2023. Notice
- On January 4, CMS released the latest enrollment figures for Medicare, Medicaid, and CHIP. As of September 2022, 65,103,807 people are enrolled in Medicare and 90,933,769 people are enrolled in Medicaid and CHIP. Enrollment Figures
- Also on January 4, CMS released guidance for states to enhance and expand the use of “in lieu of services and settings” in Medicaid managed care to address health-related social needs for Medicaid beneficiaries. Press Release Guidance
- Also on January 4, MACPAC released a brief, “Estimates of Medicaid Nursing Facility Payments Relative to Costs.” Brief
- On January 5, CMS announced that New York submitted a section 1115 demonstration amendment that seeks to authorize federal Medicaid matching funds for services delivered to beneficiaries in Institutions for Mental Diseases with behavioral health diagnoses. The comment period is open from January 5 through February 4, 2023. Pending Application Comments
- Also on January 5, CMS announced that Oklahoma submitted a five-year extension request for their section 1115 demonstration, which authorizes the SoonerCare Choice Patient-Centered Medical Home. The comment period is open from January 5 through February 4, 2023. Pending Application Comments
- Also on January 5, CMS released a State Health Official (SHO) letter that provides guidance on coverage and payment of interprofessional consultation in Medicaid and CHIP to create an easier path to specialty care for beneficiaries. Press Release Letter
- Also on January 5, CMS announced that Kansas submitted a five-year extension request of its Medicaid section 1115 demonstration “KanCare,” which proposes to transition some features into more permanent authorities and extend demonstration features including continuous eligibility for certain low-income adults and children. The comment period is open from January 5 through February 4, 2023. Pending Application Comments
- Also on January 5, CMS issued an informational bulletin on the provisions included in the Consolidated Appropriations Act, 2023 related to the Medicaid continuous enrollment condition. Bulletin
- On January 6, CMS released an updated resource on strategies to engage Medicaid managed care plans to maximize continuity of coverage following the end of the COVID-19 Medicaid continuous enrollment requirement. Resource
- Also on January 6, CMS announced that Rhode Island submitted a five-year extension request of its Medicaid section 1115 demonstration, “Rhode Island Comprehensive Demonstration,” which operates the state’s entire Medicaid program and offers a complete array of services. The comment period is open from January 6 through February 5, 2023. Pending Application Comments
Payment & Delivery System Models –
Public Health Prevention, Surveillance, & Data –
- COVID-19 Data: To date, there are 101,094,670 total COVID-19 cases and 1,091,184 COVID-19 deaths in the United States. Also, 942,343,115 COVID-19 vaccines have been delivered and 665,076,272 individual COVID-19 vaccine doses have been administered. Data
- FDA Action Update: To date, FDA has authorized 442 tests under Emergency Use Authorizations (EUAs), including 297 molecular tests, 85 antibody tests, 59 antigen tests, and one diagnostic breath test. FDA also continues to update COVID-19 FAQs.
- On January 5, CDC announced an order requiring negative pre-departure COVID-19 test results or documentation of recovery from COVID-19 for aircraft passengers traveling to the U.S. from the People’s Republic of China or departing from a designated airport if the passenger has been in the People’s Republic of China within the 10 days prior to their departure for the U. S. Notice
- On January 6, CDC released a report on mpox cases among cisgender women and pregnant persons, finding that among 769 mpox cases reported among cisgender women, Black or African American and Hispanic or Latino women were disproportionately affected. Report
- Also on January 6, CDC issued a notice announcing the establishment of the Center for Forecasting and Outbreak Analytics, which would advance U.S. forecasting, outbreak analytics, and surveillance capacities related to disease outbreaks, epidemics, and pandemics to support public health response and preparedness. Notice
Health IT, Privacy, & Digital Health –
- On January 3, HHS announced a settlement with Life Hope Labs, LLC in Sandy Springs, Georgia, concerning a potential violation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule’s right of access provision. Press Release
- Also on January 3, the National Institutes of Health (NIH) All of Us Research Program announced awards of up to $4.75 million in FY2023 for research grants to advance precision medicine. These grants will help support analysis of the Researcher Workbench data using standard tools and methods, as well as the development and use of new tools or methods. Announcement
- On January 4, the ONC published a blog on the history and current state of the adoption and implementation of bulk data APIs. Blog
- On January 5, the ONC published a blog on a recent ONC study that sought to identify racial and ethnic disparities in patient portal offers, access, and use. Blog Study
- Also on January 5, NIH launched the Home Test to Treat program, an entirely virtual community health intervention that will provide free COVID-19 health services—at-home rapid tests, telehealth sessions and at-home treatments—in selected communities. Press Release
- Also on January 5, the Health Resources and Services Administration (HRSA) released an information collection request outlining updates to its uniform data system (UDS), including demographic characteristics, quality of care measures, and health center health information technology capabilities. Comments are due by February 6, 2023. Information Collection Request
- Also on January 5, CMS announced that it added a new telehealth indicator on clinician profile pages on Medicare Care Compare and in the Provider Data Catalog (PDC). This indicator helps beneficiaries and caregivers more easily find clinicians who provide telehealth services. Fact Sheet
- On January 6, HRSA released an information collection request for the Office for the Advancement of Telehealth’s (OAT) Evidence Based Telehealth Network Program. Comments are due by February 8, 2023. Information Collection Request
- Also on January 6, the HHS OIG released audit findings which found that Illinois generally made telehealth payments that were in accordance with federal and state requirements when claiming Medicaid reimbursement for telehealth payments during COVID-19. Report in Brief Report
Mental Health and Substance Use Disorder Policy –
- On January 4, the Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of its annual National Survey on Drug Use and Health (NSDUH), which shows how people living in America reported about their experience with mental health conditions, substance use, and pursuit of treatment in 2021. SAMHSA Press Release HHS Press Release Report Report Highlights
Prescription Drugs, Medical Devices, & Biomedical Research –
- On January 5, NIH announced that a research team developed a new approach to better understand the biology of polycystic kidney disease (PKD). The results could lead to better ways to test and develop treatments for PKD, and perhaps other diseases. Press Release
- On January 6, the FDA approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Announcement CMS Statement
Veterans Health and Military Health –
- On January 4, the Department of Veterans Affairs (VA) announced the screening of one million Veterans for military exposures as part of the PACT Act, which was signed into law on August 10, 2022. Press Release
- Also on January 4, GAO released a report on the Veterans Health Administration (VHA) updated specialty care scheduling process, VHA’s scheduling timeliness standards, and VHA’s efforts to provide training on the updated process. GAO made three recommendations, including that VHA conduct an analysis of scheduling timeliness data from all VA medical centers and require training. Report in Brief Report
Health Systems, Public Health, & Health Equity –
- On January 4, HRSA released an information collection request on the Health Center Patient Survey (HCPS), which surveys patients of HRSA-supported health centers. Comments are due by March 6, 2023. Information Collection Request
- Also on January 4, HRSA released an information collection request on Health Professional Shortage Area designations and Medically Underserved Area/Medically Underserved Population designations, which identify and dedicate resources to areas and populations in greatest need of providers. Comments are due by March 6, 2023. Notice
- Also on January 4, HRSA released a request for information on the perspectives of Healthy Start grantees, community members, people with lived experience, health care providers, community health workers, birthing people, parents, and other members of the public to inform future Healthy Start program development. Comments are due by February 3, 2023. Request for Information
- On January 5, HRSA released a notice with updates to the Bright Futures Periodicity Schedule, as part of the HRSA-supported preventive services guidelines for infants, children, and adolescents. Notice
- On January 6, CDC released a report on racial and ethnic differences in rates of COVID-19 vaccination status among young children. Report
Reproductive & Maternal Health –
- On January 3, the FDA released a notice modifying the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to reduce burden and to ensure the benefits of the product outweigh the risks. This modification will enable more pharmacies to dispense the drug, among other changes. FDA Announcement Notice
- On January 5, HRSA released a notice outlining updates to the HRSA-supported Women’s Preventive Services Guidelines related to screening for diabetes in pregnancy and screening for diabetes after pregnancy. Notice
- Also on January 5, Sens. Warren (D-MA) and Hirono (D-HI), and Rep. Bush (D-MO), sent a letter to Department of Labor (DOL) Principal Deputy Administrator Looman urging DOL to ensure independent contractors receive abortion benefits. Press Release Letter
- On January 6, CDC released statistics on the percentage of mothers with gestational diabetes between 2016 and 2021. Report
Misc. –
- On January 4, the White House released a fact sheet on 2023 plans for implementing the Bipartisan Infrastructure Law. Fact Sheet
- Also on January 4, the Office of Management and Budget (OMB) released the fall regulatory agenda, which lists anticipated rulemaking from federal agencies over the next year. Regulatory Agenda
- On January 5, the Federal Trade Commission (FTC) issued a notice of proposed rulemaking (NPRM) to prohibit employers from imposing noncompete clauses on workers, supporting President Biden’s Executive Order on Promoting Competition in the American Economy. Comments are due 60 days after the rule is published in the Federal Register. Proposed Rule Fact Sheet Press Release
- Also on January 5, President Biden announced key regional appointments at the General Services Administration (GSA) and HHS. Press Release
Legislative Activity –
Votes and Committee Activity –
- On January 1, House Committee on Rules Republicans introduced a resolution containing its proposed Rules package for the 118th Congress. Notable rule changes that will have implications on health policies include the creation of a select panel to investigate the origins of the COVID-19 pandemic and replacement of pay-go rules with a cut-as-you-go rule, among others. Resolution text Section-by-section
- On January 5, President Biden signed the Dr. Joanne Smith Memorial Rehabilitation Innovation Centers Act of 2022 (S.2834) into law. The legislation directs CMS to publish and biennially update a list of all rehabilitation innovation centers. Bill text Press release
- Also on January 5, President Biden signed the Childhood Cancer STAR Reauthorization Act (S. 4120) into law. The legislation reauthorizes the program through FY2028 and modifies pediatric cancer research and related programs, including to expand collection of and access to relevant biospecimens and to support the transition of pediatric cancer survivors to primary care. Bill text Press release
- Also on January 5, President Biden signed the State Offices of Rural Health Program Reauthorization Act of 2022 (S. 4978) into law. The legislation reauthorizes grants awarded to state offices of rural health for improving health care in rural areas through FY2027. Bill text Press release
- Also on January 5, President Biden signed the Colonel Mary Louise Rasmuson Campus of the Alaska VA Healthcare System Act of 2022 (S. 5016) into law. The legislation designates the medical center of the Department of Veterans Affairs in Anchorage, Alaska, as the Colonel Mary Louise Rasmuson Campus of the Alaska VA Healthcare System. Bill text Press release
- On January 7, Rep. McCarthy (R-CA) was elected Speaker of the House of Representatives. Votes
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