[HIV-STD-Prevention] Weekly Prevention Resources - 11/20/24 #u#

[Shelley Pearson (she/her)]

Hello, HIV and STI prevention partners!

Welcome to this week’s HIV/STI Prevention listserv email! Please email me at shelley.m.pearson at oha.oregon.gov<mailto:shelley.m.pearson at oha.oregon.gov> with any feedback about the listserv, with announcements/resources to share to the list, or if you have colleagues who would like to be added to the list. For more information about the resources shared, please reach out via the contact information in each item. Thank you!

Just one item this week:

  *   PrEP Access Updates from NASTAD



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The HIV pre-exposure prophylaxis (PrEP) access landscape has featured a number of changes this Fall. This memo provides details on the various announcements and updates that have occurred since late September of this year, including updated PrEP coverage guidance, changes to Gilead Science’s patient assistance programs, and the Centers for Medicare & Medicaid Service’s (CMS) final National Coverage Determination (NCD) for PrEP. Rather than sending members multiple emails on each topic, NASTAD has compiled these access updates into one streamlined memo – a bountiful harvest of PrEP access updates.



Updated PrEP Coverage Guidance



On October 21, the Department of Health and Human Services (HHS), Department of Labor, and Department of Treasury issued updated marketplace and private insurance guidance<https://www.cms.gov/files/document/faqs-implementation-part-68.pdf> regarding federal coverage requirements for PrEP. Following the USPTSF’s August 2023 re-release of an expanded Grade A recommendation for PrEP, the FAQ-based guidance document clarifies that health insurance plans subject to all provisions of the Affordable Care Act  must cover, without cost sharing, the three FDA-approved PrEP formulations (two oral and one injectable) and are not permitted to use utilization management techniques (e.g., prior authorization processes) to preferentially direct individuals prescribed PrEP to utilize one formulation over another. Current FDA-approved formulations include:

  *   oral tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; brand name Truvada®)
  *   oral tenofovir alafenamide fumarate and emtricitabine (TAF/FTC; brand name Descovy®), and
  *   injectable cabotegravir (brand name Apretude®).

Updated coverage requirements went into effect August 31, one year after the updated Grade A recommendation was released in August 2023. The updated guidance will not apply to future PrEP formulations approved by FDA, such as lenacapavir.

Stay tuned for updates to NASTAD resources incorporating this guidance.



Gilead Sciences Payment Assistance Program Changes



Gilead Sciences has announced that, beginning January 31, 2025, its Advancing Access patient assistance program (PAP) will stop providing Truvada® due to broad availability of generic TDF/FTC (current average pharmacy acquisition cost price: $18.00 per 30 tablets). Eligible Advancing Access enrollees will continue to receive Truvada® free of charge until January 31, 2025, and new enrollments in the program may continue until one month prior to the program end (December 31, 2024).



The Advancing Access program has included an exception process for up to six months for individuals assigned female at birth prescribed Truvada® for HIV prevention who have affordability challenges with generic TDF/FTC. Individuals assigned female at birth may receive notifications of termination since the free drug program does not currently distinguish gender as eligibility criteria. However, through an exceptions process, eligible individuals assigned female at birth can call Advancing Access (800-226-2056) and request an exception. For these eligible individuals, the Truvada® free drug program will end on July 31, 2025, and that will be the last day to both receive free product and to enroll in the program.

Advancing Access cost-sharing assistance for Truvada®, along with Descovy®, will continue to remain available.



CMS’s PrEP for HIV National Coverage Determination



On September 30, CMS released its final National Coverage Determination<https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=310> (NCD) regarding Medicare coverage for PrEP. Under this NCD, all PrEP services for Medicare beneficiaries are to be covered under Part B, including access to oral and injectable PrEP medications and other services without cost-sharing. The following PrEP services are added preventive benefits and should not incur any Medicare Part B deductible, copayment, or coinsurance costs to the beneficiary: Up to eight individual counseling visits every 12 months that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction, and medication adherence.  Counseling must be furnished by a physician or other health care practitioner.  Individuals must be competent and alert at the time that counseling is provided.

  *   Up to eight HIV screening tests every 12 months.
  *   A single screening for hepatitis B virus (HBV).

Prior to the final NCD, PrEP medications were covered under Medicare Part D and subject to deductibles and copayments. By moving the coverage of PrEP medications under Part B, CMS was able to require $0 cost-sharing associated with these drugs for beneficiaries vulnerable to HIV infection.

For patients to receive PrEP without cost-sharing, their PrEP medications must be dispensed by a pharmacy in the Medicare Part B network. To bill for oral HIV drugs, pharmacies must be enrolled as either 1) a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier (CMS855S), or 2) a Part B Pharmacy supplier (CMS-855B). CMS released fact sheets and FAQs leading up to the final NCD to help ease pharmacies with the transition of billing Medicare Part B. The fact sheet and FAQ contain helpful information, such as billing codes and Medicare enrollment information for pharmacies. These resources can be accessed below.

  *   CMS Fact Sheet: Medicare Part B Coverage of Pre-exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention<https://www.cms.gov/files/document/fact-sheet-potential-medicare-part-b-coverage-preexposure-prophylaxis-prep-using-antiretroviral.pdf>
  *   PrEP for HIV National Coverage Determination (NCD) Technical Frequently Asked Questions for Pharmacies<https://www.cms.gov/files/document/faq-prep-hiv-06242024.pdf>

Clinics and other providers of HIV prevention care services to Medicare beneficiaries may also be able to purchase PrEP medications themselves, dispense them directly, and include their costs as part of their Medicare Part B or Medicare Advantage billing processes.



NASTAD will continue to share updates on PrEP access landscape changes, and advocate for the implementation of updated PrEP coverage guidance. For questions on any of the updates shared in this memo, please contact PrEP at NASTAD.org<mailto:PrEP at NASTAD.org>.



Stephen Lee MD, MBA, DHSM
Executive Director
Pronouns: He/Him/His
202.897.0028 | slee at NASTAD.org<mailto:slee at NASTAD.org>
NASTAD | 444 North Capitol Street NW, Suite 339 | Washington, DC 20001| NASTAD.org<https://nastad.org/> 




Shelley Pearson
Pronouns: she/her/hers
HIV/STI Administrative and Communications Specialist
OREGON HEALTH AUTHORITY
Public Health Division
shelley.m.pearson at oha.oregon.gov<mailto:shelley.m.pearson at dhsoha.state.or.us>
Phone: 503-381-6173
Fax: 971-673-0178

[cid:image003.png at 01DB3B66.63788F70]<http://www.endhivoregon.org/>



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