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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 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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A Look into House Efforts on Hospital and Health Plan Price Transparency

In the 118th Congress, the US House of Representatives is keenly interested in healthcare price transparency. Three House committees—Energy and Commerce, Ways and Means, and Education and the Workforce—each approved legislation that would advance price transparency objectives. Generally, these bills seek to codify (or modify) the requirements around hospital and health plan price transparency as previously implemented by the Centers for Medicare & Medicaid Services.

While there are many similarities between the three bills, the committees and House leadership will need to negotiate certain key differences before a bill is brought to the House floor for a vote. It remains unclear which of the competing bills might get a vote.

This +Insight examines the hospital and health plan transparency provisions of these primary pieces of legislation and compares them with current regulations.

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CMS Releases Proposed Rule: Medicaid Program; Ensuring Access to Medicaid Services

On May 3, 2023, the Centers for Medicare & Medicaid Services (CMS) published the proposed rule Medicaid Program; Ensuring Access to Medicaid Services. The aim of the proposed rule is to enhance transparency in payment rates, establish uniformity in data and monitoring and provide states with fresh avenues to encourage the active involvement of beneficiaries in their Medicaid programs. These efforts are aimed at enhancing access to care. The rule places a special emphasis on home and community-based services (HCBS), encompassing mandates for direct care worker compensation, the development of grievance processes, defining critical incident reporting and implementing HCBS quality reporting measures.

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Federal Government to Wind Down Vaccination Mandates

The Biden administration has announced that the federal government will wind down its remaining COVID-19 vaccination mandates (including those for federal workers, contractors and international air travelers) effective May 11, 2023. This action coincides with the conclusion of the COVID-19 public health emergency (PHE). Additionally, the US Department of Health and Human Services (HHS) will initiate steps to terminate the vaccination prerequisites for healthcare facilities that are certified by the Centers for Medicare & Medicaid Services (CMS).

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Healthcare Preview for the Week of May 1, 2023

There has been a flurry of activity in Congress focused on healthcare issues over the last two weeks. Committees in both the US House and Senate held hearings on legislation focused on increasing transparency and competition in the healthcare system that could have significant impacts for certain healthcare providers, healthcare plans and pharmacy benefit managers.

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New California Law Requires Open Payments Notice to Patients

On September 29, 2022, California Governor Gavin Newsom signed Assembly Bill 1278, which requires physicians and their employers to provide patients with notices about the Open Payments database starting January 1, 2023.

The federal Open Payments program is designed to promote transparency by requiring applicable manufacturers of drugs, devices, and biological or medical supplies to annually report to the Centers for Medicare & Medicaid Services certain payments and other transfers of value made to physicians, certain advanced practice providers (e.g., nurse practitioners) and teaching hospitals. Currently, pharmaceutical companies in California must disclose their compliance program, including information related to the annual dollar limits on gifts, promotional materials or incentives provided to medical or health professionals (California Health & Safety Code § 119402). The enactment of this new legislation will impose new disclosure requirements specifically onto physicians and their employers regarding physicians’ financial relationships with pharmaceutical and medical device manufacturers.

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