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CMS Issues Guidance on Usage of AI in Making Coverage Determinations

On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) issued a letter to all Medicare Advantage (MA) organizations and Medicare-Medicaid plans. The letter covered frequently asked questions and answers related to the coverage criteria and utilization management requirements in the CMS Final Rule issued on April 5, 2023.

Among the FAQs was guidance related to the use of artificial intelligence (AI) and other technologies to assess coverage decisions. CMS wrote, “An algorithm or software tool can be used to assist MA plans in making coverage determinations, but it is the responsibility of the MA organization to ensure that the algorithm or artificial intelligence complies with all applicable rules for how coverage determinations by MA organizations are made.” For example, in a decision to terminate post-acute care services, an algorithm or software tool can be used to predict the potential length of stay, but that prediction alone cannot be used as the basis to terminate services.

CMS also expressed concern that algorithms and AI technologies can exacerbate discrimination and biases, emphasizing that MA organizations must comply with nondiscrimination requirements of Section 1557 of the Affordable Care Act.




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CMS Releases CY 2025 Advance Notice for Medicare Advantage and Part D

On January 31, 2024, the US Centers for Medicare & Medicaid Services (CMS) released the Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and D Payment Policies. CMS also released a press release and fact sheet. The advance notice is released on an annual basis and includes proposed updates to the capitation and risk adjustment methodologies used to calculate payments to MA plans, as well as other payment policies that impact Part D. The final CY 2025 rate announcement will be published no later than April 1, 2024.

The advance notice discusses several updates the Inflation Reduction Act of 2022 (IRA) made for 2025, including:

As a result of the IRA, CMS proposes updates to the Part D risk adjustment model to reflect the Part D benefit design.

CMS is annually required to update the parameters for the defined standard Part D drug benefit. This is meant to ensure that the actuarial value of the drug benefit tracks changes in Part D expenses. For non-low-income subsidy beneficiaries, the advance notice outlines the benefit parameters for defined standard benefits in 2025 as follows:




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CMS Announces New GUIDE Model to Support People Living with Dementia and Their Caregivers

To support people living with dementia and their unpaid caregivers, the US Centers for Medicare & Medicaid Services recently announced the Guiding an Improved Dementia Experience (GUIDE) Model, a new, voluntary and nationwide test model designed specifically for these two rapidly growing demographic groups. The model will offer care coordination and care management for individuals living with dementia and provide education, support and respite services for their caregivers.

The GUIDE model will launch on July 1, 2024.

Read more here.




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CMS Seeks Provider and Stakeholder Feedback on First National Directory of Healthcare Providers and Services

CMS is soliciting feedback on the creation of the first national directory of healthcare providers and services (NDH), which would contain information on healthcare providers and services across the country. CMS states that the NDH would improve and support interoperability throughout the healthcare sector for payers and providers while making it easier for patients to identify, compare and locate providers who meet their specific needs and preferences, such as those related to office accessibility, languages spoken or other data. CMS proposes that consolidating provider data into a single source would ultimately reduce the unnecessary burden placed on providers to maintain dozens of separate directories while improving access to care. The new system would be used in place of commercial payor directories and allow payers to update their own directories seamlessly from a single directory. CMS is proposing integrating the NDH with current CMS-maintained systems (i.e., NPPES, PECOS and Care Compare).

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CMS Recommends Cost Savings Be Passed Along to Medicare Part B Beneficiaries

The US Centers for Medicare & Medicaid Services (CMS) recently released a report recommending that cost savings from lower-than-expected Medicare Part B spending be passed along to individuals with Medicare Part B coverage in the calculation of the 2023 Part B premium.

CMS’s recommendations are based upon the development of the Part B premium and the potential effects of factors that have changed since a premium was announced on a drug used for the treatment of Alzheimer’s disease. CMS builds in a reserve to ensure the Medicare Supplementary Medical Insurance (SMI) Trust Fund remains adequately financed for the year. In 2021, CMS built in a reserve to ensure the SMI Trust Fund could cover the potential costs of the Alzheimer’s disease drug and similar drugs.

Read McDermott’s latest Healthcare Regulatory Check-Up newsletter here.




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Federal Vaccine Mandates Are Back in Play (For Now)

The courts continue to move the vaccine mandate goalposts on employers as dozens of legal challenges work their way through the courts. The latest developments are major game changers for employers. As of today, the US Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) vaccine-or-test rule is enforceable nationwide, and the US Centers for Medicare & Medicaid Services (CMS) Interim Final Rule (IFR) mandating vaccination, subject to exemptions, is enforceable in 25 states.

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