Medicare’s Proposed NCD for PrEP: Coverage Shift to Part B & Zero Dollar Cost-sharing

Relevant to: Utilization Management, Part D

Each week, we scan the latest CMS memos to find the most important ones that apply for PACE programs. Below is a summary of what you need to know.

Disclaimer: The content provided on this site is a summary for informational purposes only, and Grane PBM, Inc. assumes no liability for any errors or omissions in the site’s content. The information does not constitute legal or regulatory advice or replace the original CMS memo. Readers are advised to consult the CMS memo in its entirety and to verify information independently before making any decisions based on this information.

Click here to read the complete memo from CMS.

Introduction

The Centers for Medicare & Medicaid Services (CMS) has proposed a significant change in the National Coverage Determination (NCD) for Preexposure Prophylaxis (PrEP) for HIV prevention. This proposal outlines the coverage of FDA-approved antiretroviral drugs and counseling visits for high-risk individuals, transitioning PrEP coverage from Part D to Part B. The final decision is anticipated in September 2024, aiming to streamline access and ensure minimal cost-sharing for beneficiaries.

Key Dates and Deadlines

  • Proposed Decision Memorandum Published: July 12, 2023
  • Date of Memo: August 1, 2024
  • Expected Date for Final NCD Posting: Late September 2024
  • Expected Effective Date of Final NCD: Same as Posting Date

PACE Compliance

This memo is relevant to PACE programs because of its implications for coverage of preexposure prophylaxis (PrEP) for HIV prevention under Medicare. The proposed National Coverage Determination (NCD) outlines specific requirements for coverage of PrEP, including antiretroviral drugs approved by the FDA and related counseling services.

Plans must adhere to the proposed NCD by ensuring PrEP is covered along with the additional screening tests and counseling services without any cost-sharing when provided by in-network providers. This compliance is critical to ensure that individuals at high risk for HIV have access to necessary preventive care and medications.

PACE organizations, like other Medicare Advantage Organizations, are expected to coordinate with their network pharmacies and providers to facilitate a smooth transition and accurate point-of-sale transactions. This coordination is necessary to make certain that coverage determinations are made expeditiously and align with the enrollee’s health requirements as stipulated in the proposed NCD.

Moreover, PACE organizations must communicate these changes to beneficiaries, ensuring they understand the transition of PrEP from Part D to Part B coverage and are informed about the cost-sharing implications associated with the new coverage policy.

Timely communication and advanced preparation by PACE organizations can help mitigate any potential disruptions in care and ensure beneficiaries continue to receive their necessary preventive services without unnecessary hurdles.

Required Actions

On July 12, 2023, CMS issued a proposed decision memorandum to cover PrEP for HIV prevention. This memorandum outlines that CMS will cover the use of antiretroviral drugs approved by the FDA and up to seven individual counseling visits per year. Final decisions for the National Coverage Determination (NCD) are expected in late September 2024. MA organizations and Part D plans will need to prepare for potential transitions from Part D to Part B coverage.

1. Encourage pharmacies and interested parties to prepare for the transition of PrEP coverage from Part D to Part B. Guidance for transitioning will help minimize disruption to care.

2. Communicate the expected change in coverage to beneficiaries. Ensure those affected are informed about the shift from Part D to Part B and the classification of PrEP as a zero-dollar cost-sharing preventive service under Part B.

3. Coordinate with network providers and pharmacies to ensure accurate and timely point-of-sale transactions, accommodating the new status of PrEP under Part B. Part D plan sponsors should implement point-of-sale messaging to inform pharmacies of PrEP’s coverage change to Part B.

FAQs

  • What is the proposed National Coverage Determination (NCD) for HIV prevention?
  • How will the NCD affect coverage of PrEP for Medicare beneficiaries?
  • What preparations should Medicare Advantage (MA) organizations and Part D plan sponsors make for the change in PrEP coverage?
  • Will there be any cost-sharing for PrEP under the new NCD?
  • How can pharmacies prepare for billing PrEP under Part B?

Click here to read the complete memo from CMS.

Contact Us

Let's Discuss How We Can Support Your Business

Get real-time memo alerts in your inbox