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340B Remedy Rule and Medicare Advantage Rates: Navigating Shifting Payments

On April 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the Announcement of Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, otherwise known as the rate announcement. The rate announcement is released annually and includes updates to the methodologies used to calculate MA plan payments, as well as other payment policies that impact Part D. The CY 2025 rate announcement finalizes the policies proposed in CMS’s January 2024 advance notice.

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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 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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Pharmacy Benefit Manager Reform: What’s on the Horizon? (December 2023 Update)

The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit managers (PBMs) are a key stakeholder in the drug supply chain, functioning as intermediaries between insurance providers and pharmaceutical manufacturers.

Congress and other stakeholders are raising questions about PBMs’ operations and their impact on drug prices and out-of-pocket costs for patients. In the 118th Congress, six key committees have advanced legislation that would increase PBM transparency and reporting obligations and modify other business practices. In the House, three committees combined to introduce H.R. 5378, the Lower Costs, More Transparency Act, which passed the House December 11, 2023. Read on as we review and compare policies in the Lower Costs, More Transparency Act and the PBM bills considered individually by the relevant House and Senate committees.

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Pharmacy Benefit Manager Reform: What’s on the Horizon?

The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government.

Pharmacy benefit managers (PBMs) are a key stakeholder in the drug supply chain, functioning as intermediaries between insurance providers and pharmaceutical manufacturers. PBMs administer prescription drug benefits and seek discounts for insurers as standalone plans, such as Medicare Part D plans, or as entities embedded in commercial insurance products, including Medicare Advantage, Medicaid Managed Care Organizations and employer-sponsored coverage.

PBMs are under increased scrutiny from policymakers due to the perceived opaqueness of their operations and their perceived role in increasing drug costs. As part of this scrutiny, Congress and other stakeholders are raising questions about PBMs’ impact on drug prices and out-of-pocket costs for patients. In the 118th Congress, several key committees have advanced legislation that would increase PBM transparency and reporting obligations and modify other business practices.

Read on for a side-by-side comparison of US House and US Senate PBM bills and our forecast of the possible effects of these proposed changes to PBM operations.




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Tenth Circuit Reaffirms Preemption of State Pharmacy Network Regulations

The US Court of Appeals for the Tenth Circuit recently held in Pharmaceutical Care Management Association v. Mulready (PCMA) that the Employee Retirement Income Security Act (ERISA) and Medicare Part D preempted several provisions of Oklahoma law regulating pharmacy benefit managers and pharmacy networks. Left unchallenged, these provisions threaten the ability of employers and Medicare Advantage organizations to design uniform nationwide health plans. The Tenth Circuit’s decision in favor of PCMA overturned a lower court decision that caused great concern about the ability of states to indirectly dictate the design of plans governed by ERISA and Medicare Part D.

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HHS OIG Develops Toolkit to Analyze Telehealth Claims to Assess Program Integrity Risks

The US Department of Health and Human Services Office of the Inspector General (HHS OIG) recently unveiled a new toolkit that seeks to help analyze telehealth claims for federal healthcare program integrity risks. It is based on methodologies highlighted in OIG’s September 2022 data brief; the data brief identified billing practices by Medicare providers that OIG was concerned posed a high risk to program integrity. OIG intends for the toolkit to be used by public and private parties—including Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units and other federal healthcare agencies—to assess program integrity risks and identify providers whose billing may warrant further scrutiny.

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Proposed Rule on MA and Part D Would Reinstate Historical Requirements, Make Changes to Prescription Drug Payment Structure

On January 6, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule regarding Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs, marking the Biden administration’s first proposed rule on these topics. The proposed rule includes proposed changes to the manner in which pharmacy price concessions are accounted for in the Part D benefit, the timing of network adequacy reviews for Medicare Advantage Organization (MAO) applicants, and new rules regarding oversight of third-party marketing organizations. The proposed rule also reverses course on some policy changes that were initiated under the prior administration, including changes related to medical loss ratio (MLR) reporting and past performance evaluations. The proposed rule includes proposed policy updates for Dual Eligible Special Needs Plans (D-SNPs) and a few provisions related to the ongoing COVID-19 public health emergency (PHE).

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CMS Releases Broad-Ranging Medicare Advantage and Part D Proposed Rule

CMS released a broad-ranging proposed rule for the Medicare Advantage and Part D Programs on Thursday, November 16, 2017. The proposed rule addresses a broad and diverse range of MA and Part D regulatory requirements, affecting not only Medicare Advantage Organizations and Part D Sponsors, but also health care providers, pharmacies, pharmaceutical manufacturers and others.

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