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Centers for Medicare & Medicaid ServicesCMS Roundup
Today, the Centers for Medicare & Medicaid Services (CMS) provides an at-a-glance summary of news from around the agency.
*CMS Proposes Rule to the Mitigate Impact of Significant, Anomalous, and Highly Suspect (SAHS) Billing Activity on Medicare Shared Savings Program *
June 28: CMS released a proposed rule titled “Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023.” As outlined in CMS' newly released Physician Fee Schedule, this proposed rule is part of a larger strategy to address SAHS billing activity within the accountable care organizations (ACO) reconciliation process. Details of the proposed rule can be found in this fact sheet [ https://www.cms.gov/newsroom/fact-sheets/proposed-rule-mitigating-impact-significant-anomalous-and-highly-suspect-billing-activity-medicare ], and the proposed rule can be found in the Federal Register here [ https://www.federalregister.gov/documents/2024/07/03/2024-14601/medicare-program-mitigating-the-impact-of-significant-anomalous-and-highly-suspect-billing-activity ], with the comment period ending July 29, 2024.
*CMS Releases Request for Application for States to Participate in the Cell and Gene Therapy Access Model*
June 28: CMS announced the state Request for Applications [ https://www.cms.gov/files/document/cgt-model-rfa.pdf ] (RFA) for participants in the Cell and Gene Therapy (CGT) Access Model. The CGT Access Model is a voluntary model that aims to improve the lives of people with Medicaid living with rare and severe diseases by increasing access to potentially transformative treatments. All states and U.S. territories that participate in the Medicaid Drug Rebate Program (MDRP) are eligible to apply to participate in the model. More details on the RFA are included in this fact sheet [ https://www.cms.gov/files/document/cgt-model-rfa-fact-sheet.pdf ].
*CMS Publishes Program Year 2023 Open Payments Data*
June 28: CMS published Program Year 2023 Open Payments data to the public website as part of its ongoing commitment to improving transparency in health care. The data includes Program Year 2023 data submitted and attested to by applicable manufacturers and group purchasing organizations that are required to annually report payments made to certain health care providers, including physicians and teaching hospitals.
*CMS Issues 4th Evaluation Report of the Vermont All-Payer Accountable Care Organization Model*
June 28: CMS released the 4th Annual Evaluation Report [ https://www.cms.gov/priorities/innovation/data-and-reports/2024/vtapm-4th-eval-full-report ] of the Vermont All-Payer Accountable Care Organization Model [ https://www.cms.gov/priorities/innovation/innovation-models/vermont-all-payer-aco-model ] (VTAPM). This model tests whether scaling an accountable care organization (ACO) model across all major payers in the state facilitates broad care delivery transformation, reduces statewide spending, and improves population health outcomes. The VTAPM achieved statistically significant cumulative gross and net Medicare spending reductions over the first five performance years (2018-2022) for people with Medicare who were aligned with the Medicare ACO initiative. Spending reductions appear to be primarily driven by declines in acute care utilization. There are also noted reductions in specialist visits among those served by ACOs in the initiative, triggered by increasing demand and a lack of sufficient providers. In addition to the full report, a two-page “At-A-Glance” summary can be found here [ https://www.cms.gov/priorities/innovation/data-and-reports/2024/vtapm-4th-eval-report-aag ].
*Oregon Implements Basic Health Program Approved by CMS*
July 1: Following CMS’ approval [ https://www.medicaid.gov/basic-health-program/downloads/or-basic-hlth-prgm-blprnt-jun-2024.pdf ] of its Basic Health Program Blueprint, the State of Oregon has implemented the Oregon Basic Health Program (BHP), which provides essential health benefits to individuals with incomes from 138% to 200% of the federal poverty level who would otherwise be eligible for enrollment in the Marketplace. Oregon became the third state to implement a BHP and expects to cover some 55,000 residents. Additional information about the Oregon BHP can be found here [ https://content.govdelivery.com/accounts/ORHA/bulletins/3a6091e ].
*CMS Announces Coverage of Kisunla for the Treatment of Alzheimer’s Disease*
July 2: CMS announced Medicare coverage is now available for Eli Lilly’s Kisunla (donanemab-azbt) following the Food and Drug Administration’s (FDA) move to grant traditional approval to the drug that treats individuals with Alzheimer’s disease. Kisunla joins Biogen and Eisai’s Leqembi (the brand name for lecanemab-irmb) as the second monoclonal amyloid beta antibody treatment granted traditional FDA approval for Alzheimer’s disease. Medicare covers the drugs with traditional FDA approval in this class when a prescribing clinician or their staff decides the Medicare coverage criteria are met and submits information to help answer treatment questions in a qualifying study. CMS posted updated fact sheets for providers [ https://qualitynet.cms.gov/files/64a7151bd15911001c695b32?filename=Provider%20Factsheet%20Alzheimers%20Treatment.pdf ] and consumers [ https://qualitynet.cms.gov/files/64a7152ed15911001c695b35?filename=Consumer%20Factsheet%20Alzheimers%20Treatment.pdf ] about the CMS National Patient Registry for New Alzheimer’s Drugs. Additional information on Kisunla's approval can be found here [ https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease ].
*CMS Announces First States to Participate in AHEAD Model*
July 2: CMS announced that Maryland, Vermont, and Connecticut have been selected as the first states to participate in the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model [ https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmNtcy5nb3YvcHJpb3JpdGllcy9pbm5vdmF0aW9uL2lubm92YXRpb24tbW9kZWxzL2FoZWFkIiwiYnVsbGV0aW5faWQiOiIyMDI0MDcwMy45NzExOTU5MSJ9.c365KMvHBn2oVjwCjoHGpyzCDDRL1zqvxp_swkKe1Mo/s/258887569/br/245187548323-l ]. Hawaii will also participate, pending satisfaction of certain requirements. CMS will issue Cooperative Agreements to each state, which will have the opportunity to receive up to $12 million from CMS during the first five and a half years of the model to support implementation.
Under AHEAD, CMS will collaborate with states to curb health care cost growth, improve population health, and advance health equity by reducing disparities in health outcomes. CMS will support participating states through various AHEAD Model components that aim to increase investment in primary care, provide financial stability for hospitals, and support people’s connection to community resources.
Applications to participate in Cohort 3 of the model are due August 12, 2024 at 3:00 p.m. ET. An announcement about states selected to participate in Cohort 3 is planned for Q4 2024. Resources to support states in the development of their applications are available on the AHEAD Model webpage.
*CMS Launches Guiding an Improved Dementia Experience Model*
July 8: CMS launched the Guiding an Improved Dementia Experience (GUIDE) Model on July 1 and announced the 390 organizations participating in the model, representing every state, in a blog [ https://www.cms.gov/blog/guiding-improved-dementia-experience-clearing-path-comprehensive-high-quality-dementia-care ]. The GUIDE Model [ https://www.cms.gov/priorities/innovation/innovation-models/guide ] focuses on dementia care management and aims to improve quality of life for people living with dementia, reduce strain on their unpaid caregivers, and enable people living with dementia to remain in their homes and communities.
*CMS Releases 2nd Annual Evaluation Report for the Global and Professional Direct Contracting Model*
July10: CMS released the 2nd Annual Report [ https://www.cms.gov/priorities/innovation/data-and-reports/2024/gpdc-2nd-ann-report ] for the Global and Professional Direct Contracting (GPDC) Model [ https://www.cms.gov/priorities/innovation/innovation-models/gpdc-model ]. In the second year of GPDC, the model improved quality but increased net spending. New Entrants and High Needs Direct Contracting Entities (DCEs) reduced gross spending through improvements in utilization and minor improvements in quality. Standard DCEs improved multiple quality measures but increased gross spending driven by hospital-affiliated participants. CMS is reviewing the impact of these increases in net spending on the ACO REACH Model. A two-page “At-A-Glance” summary can be found here [ https://www.cms.gov/priorities/innovation/data-and-reports/2024/gpdc-2nd-ann-report-aag ].
*CMS Launches Making Care Primary Model and Announces Model Participants*
July 10: CMS launched the Making Care Primary (MCP) Model on July 1 and announced model participants [ https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary ]. The model aims to improve primary care management and care coordination, equip primary care clinicians with tools to form partnerships with health care specialists, and leverage community-based connections to address patients’ health needs as well as their health-related social needs (HRSNs). The model will be tested in eight states with 133 participants representing 772 practices, including 55 participants that are Federally Qualified Health Centers and 94 participants that are small primary care organizations with 5 or fewer practices.
*CMS Infographic Spotlights Autism-Related Data on Children Covered by Medicaid and CHIP*
July 11: CMS released an infographic [ https://www.medicaid.gov/medicaid/benefits/downloads/2024-autism-infographic.pdf ] with information on children with Medicaid and Children's Health Insurance Program (CHIP) diagnosed with Autism. The infographic provides an overview of the prevalence of autism, characteristics of Medicaid and CHIP beneficiaries with autism, prevalence of common co-occurring health conditions, and utilization of treatment services. Approximately 5% of children with Medicaid or CHIP coverage are currently reported to have Autism or Autism Spectrum Disorder, which is significantly higher than children covered by private insurance or children without insurance coverage.
*Other Recent Releases: *
July 2: Biden-Harris Administration Reaffirms Commitment to EMTALA Enforcement [ https://www.cms.gov/newsroom/press-releases/biden-harris-administration-reaffirms-commitment-emtala-enforcement ]
July 2: HHS Authorizes Five States to Provide Historic Health Care Coverage for People Transitioning out of Incarceration [ https://www.cms.gov/newsroom/press-releases/hhs-authorizes-five-states-provide-historic-health-care-coverage-people-transitioning-out ]
_ _July 10: Biden Harris Administration Proposes Policies to Reduce Maternal Mortality, Advance Health Equity, and Support Underserved Communities [ https://www.cms.gov/newsroom/press-releases/biden-harris-administration-proposes-policies-reduce-maternal-mortality-advance-health-equity-and ]
July 10: HHS Proposes Physician Payment Rule to Drive Whole-Person Care and Improve Health Quality for All Individuals with Medicare [ https://www.cms.gov/newsroom/press-releases/hhs-proposes-physician-payment-rule-drive-whole-person-care-and-improve-health-quality-all ]_ _
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CMS, an agency within the U.S. Department of Health and Human Services, serves the public as a trusted partner and steward, dedicated to advancing health equity, expanding coverage, and improving health outcomes. The agency protects public health by administering the Medicare program and working in partnership with state governments to administer Medicaid, CHIP, and the Health Insurance Marketplace.
Get CMS news at cms.gov/newsroom [ https://www.cms.gov/newsroom ], sign up for CMS news via email [ https://www.cms.gov/About-CMS/Agency-Information/Aboutwebsite/EmailUpdates ], and follow CMS on Twitter @CMSgov [ https://twitter.com/cmsgov ]
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