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Medicare Coverage of Wegovy Raises Questions Regarding the Affordability and Accessibility of Novel Medications

The Centers for Medicare & Medicaid Services (CMS) announced in March that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they receive Food and Drug Administration (FDA) approval for an additional medically accepted indication.

In Wegovy’s case, the FDA recently approved an additional indication “to reduce the risk of major cardiovascular events (such as cardiovascular death, non-fatal myocardial infarction, or non-fatal strokes) in adults with established cardiovascular disease and either obesity or overweight” in combination with a reduced caloric diet and increased physical activity. As a result, Wegovy can be available for Medicare beneficiaries who have an established cardiovascular disease and are either overweight or obese. Part D coverage is still not available for weight-loss medications in beneficiaries who do not have the additional medically accepted indication.

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CMS Releases FY 2025 IPPS Proposed Update

On April 10, 2024, the Centers for Medicare & Medicaid Services (CMS) posted the Hospital Inpatient Prospective Payment System (IPPS) proposed update for fiscal year (FY) 2025, along with proposed policy and regulation changes. The proposed rule would update Medicare payment policies and quality reporting programs relevant for inpatient hospital services, and build on key agency priorities, including advancing health equity and improving the safety and quality of care.

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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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2024 Chart of Healthcare Regulations

During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies.

This chart displays health-related regulations that may be issued this year, organized by federal agency and date of potential release.

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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 Approves New York 1115 Medicaid Redesign Waiver

On January 9, 2024, the Centers for Medicare and Medicaid Services (CMS) approved the New York State (NY) 1115 Medicaid waiver “Medicaid Redesign Team” (MRT). The MRT is a long-standing waiver in NY that has continuously evolved to improve the administration, structure and financing of the NY Medicaid program; enhance Medicaid beneficiaries’ access to services; and improve health outcomes across the state. The recently approved waiver represents the next step in Medicaid redesign in NY and builds on the previous Delivery System Reform Incentive Payment (DSRIP) program.

This article reviews the major initiatives included in the MRT, components of the MRT that were excluded from the approval, implications for stakeholders and more.

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2024: The Year of the Telehealth Cliff

What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know?

Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date, directly impacting care and access for Medicare beneficiaries. What is this telehealth cliff?

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CMS Proposes to Prohibit Overrides in Medicare Advantage

On November 6, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule for the Medicare Advantage and Part D programs. Among other proposals, CMS proposed significant changes to longstanding rules on permissible payment structures for agents and brokers. Specifically, CMS proposes to prohibit “overrides” or administrative fees paid to agents and brokers outside of the fair market value enrollment compensation limits established by CMS. This could have a significant impact on MA and Part D plan arrangements with agents and brokers.

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Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare beneficiaries. On November 2, 2023, CMS released the calendar year 2024 final rule for services reimbursed under the Medicare Physician Fee Schedule. In the final rule, CMS clarified certain guidance for remote monitoring services, finalized separate reimbursement for remote monitoring provided by rural health centers and federally qualified health centers, and discussed a recent request for information for digital therapies.

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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.

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