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<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black">Hello, HIV and STI prevention partners!
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black">Welcome to this week’s HIV/STI Prevention listserv email! Please email me at
<a href="mailto:shelley.m.pearson@oha.oregon.gov">shelley.m.pearson@oha.oregon.gov</a> 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!<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black"><o:p> </o:p></span></p>
<div style="border:none;border-bottom:solid windowtext 1.0pt;padding:0in 0in 1.0pt 0in">
<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black">Just one item this week:
<o:p></o:p></span></p>
<ul style="margin-top:0in" type="disc">
<li class="MsoListParagraph" style="color:black;margin-left:0in;mso-list:l2 level1 lfo10">
<span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black">PrEP Access Updates from NASTAD</span><span style="font-size:12.0pt;font-family:"Verdana",sans-serif"><o:p></o:p></span></li></ul>
<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black"><o:p> </o:p></span></p>
</div>
<p class="MsoNormal"><b><span style="font-size:12.0pt;color:#337D59;mso-ligatures:none"><o:p> </o:p></span></b></p>
<div style="border:none;border-bottom:solid windowtext 1.0pt;padding:0in 0in 1.0pt 0in">
<p class="xparagraph" align="center" style="margin:0in;text-align:center;vertical-align:baseline">
<span style="font-size:13.0pt;font-family:"Calibri",sans-serif"><img border="0" width="290" height="82" style="width:3.0208in;height:.8541in" id="x_Picture_x0020_1" src="cid:image002.png@01DB3B66.63788F70"></span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span class="xeop"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#1B1B1B">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.
</span></span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in"><b><span style="color:#060606"> </span></b><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><b><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606;background:white">Updated PrEP Coverage Guidance</span></b><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><b><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606;background:white"> </span></b><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606;background:white">On October 21, the Department of Health and Human Services (HHS), Department of Labor, and Department
of Treasury issued </span><a href="https://www.cms.gov/files/document/faqs-implementation-part-68.pdf"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#019DE0;background:white">updated marketplace and private insurance guidance</span></a><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606;background:white"> 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
</span><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606">subject to all provisions of the Affordable Care Act<span style="background:white">
</span></span><span style="font-size:13.0pt;font-family:"Calibri",sans-serif"> 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<span style="color:black;background:white"> to utilize one formulation over another.
</span><span style="color:#060606;background:white">Current FDA-approved formulations include</span><span style="color:#060606">:
</span></span><o:p></o:p></p>
<ul type="disc">
<li class="xparagraph" style="color:#060606;mso-list:l3 level1 lfo7;vertical-align:baseline">
<span style="font-size:13.0pt;font-family:"Calibri",sans-serif;background:white">oral tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; brand name Truvada®)</span><o:p></o:p></li><li class="xparagraph" style="color:#060606;mso-list:l3 level1 lfo7;vertical-align:baseline">
<span style="font-size:13.0pt;font-family:"Calibri",sans-serif;background:white">oral tenofovir alafenamide fumarate and emtricitabine (TAF/FTC; brand name Descovy®), and</span><o:p></o:p></li><li class="xparagraph" style="color:#060606;mso-list:l3 level1 lfo7;vertical-align:baseline">
<span style="font-size:13.0pt;font-family:"Calibri",sans-serif;background:white">injectable cabotegravir (brand name Apretude®).</span><o:p></o:p></li></ul>
<p class="xparagraph" style="margin:0in"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606;background:white">Updated coverage requirements went into effect August 31, one year after the updated Grade A recommendation was released
in August 2023. </span><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606">The<span style="background:white"> updated guidance will not apply to future PrEP formulations approved by FDA, such as lenacapavir.
</span></span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606;background:white">Stay tuned for updates to NASTAD resources incorporating this guidance.<o:p></o:p></span></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><o:p> </o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span class="xeop"><b><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#1B1B1B">Gilead Sciences Payment Assistance Program Changes<o:p></o:p></span></b></span></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><o:p> </o:p></p>
<p class="xmsonormal" style="line-height:115%"><span style="font-size:13.0pt;line-height:115%">Gilead Sciences has announced that, beginning January 31, 2025, its Advancing Access patient assistance program (PAP) will stop providing Truvada<span style="color:#060606">®</span>
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<span style="color:#060606">®</span> 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).
</span><o:p></o:p></p>
<p class="xmsonormal" style="line-height:115%"> <o:p></o:p></p>
<p class="xmsonormal" style="line-height:115%"><span style="font-size:13.0pt;line-height:115%">The Advancing Access program has included an exception process for up to six months for individuals assigned female at birth prescribed Truvada<span style="color:#060606">®</span>
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<span style="color:#060606">®</span> 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.
</span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif">Advancing Access cost-sharing assistance for Truvada<span style="color:#060606">®</span>, along with Descovy<span style="color:#060606">®</span>, will continue
to remain available.<o:p></o:p></span></p>
<p class="xparagraph" style="margin:0in"><o:p> </o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span class="xeop"><b><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#1B1B1B">CMS’s PrEP for HIV National Coverage Determination<o:p></o:p></span></b></span></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><o:p> </o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span class="xeop"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#1B1B1B">On September 30, CMS released its final
</span></span><a href="https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=310"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif">National Coverage Determination</span></a><span class="xeop"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#1B1B1B">
(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.</span></span><o:p></o:p></p>
<ul type="disc">
<li class="xparagraph" style="color:#1B1B1B;mso-list:l6 level1 lfo8;vertical-align:baseline">
<span class="xeop"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif">Up to eight HIV screening tests every 12 months.</span></span><o:p></o:p></li><li class="xparagraph" style="color:#1B1B1B;mso-list:l6 level1 lfo8;vertical-align:baseline">
<span class="xeop"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif">A single screening for hepatitis B virus (HBV).</span></span><o:p></o:p></li></ul>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif">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.
</span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif">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.</span><o:p></o:p></p>
<ul type="disc">
<li class="xparagraph" style="color:#0563C1;mso-list:l5 level1 lfo9;vertical-align:baseline">
<a href="https://www.cms.gov/files/document/fact-sheet-potential-medicare-part-b-coverage-preexposure-prophylaxis-prep-using-antiretroviral.pdf"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif">CMS Fact Sheet: Medicare Part B Coverage of Pre-exposure
Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention</span></a><o:p></o:p></li><li class="xparagraph" style="mso-list:l5 level1 lfo9;vertical-align:baseline"><a href="https://www.cms.gov/files/document/faq-prep-hiv-06242024.pdf"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif">PrEP for HIV National Coverage Determination
(NCD) Technical Frequently Asked Questions for Pharmacies</span></a><o:p></o:p></li></ul>
<p class="xparagraph" style="margin:0in"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606">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.
</span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606"> </span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606;background:white">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
</span><a href="mailto:PrEP@NASTAD.org"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;background:white">PrEP@NASTAD.org</span></a><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#060606;background:white">.
</span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif"> </span><o:p></o:p></p>
<p class="xparagraph" style="margin:0in;vertical-align:baseline"><span class="xnormaltextrun"><b><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#008FC5">Stephen Lee MD, MBA, DHSM</span></b></span><span class="xscxw125233974"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#008FC5"> </span></span><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#008FC5"><br>
</span><span class="xnormaltextrun"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#404040">Executive Director</span></span><span class="xeop"><span style="font-size:13.0pt;font-family:"Calibri",sans-serif;color:#404040"> </span></span><o:p></o:p></p>
<p class="MsoNormal"><span class="xnormaltextrun"><span style="font-size:13.0pt;color:black">Pronouns: He/Him/His</span></span><span class="xscxw125233974"><span style="font-size:13.0pt;color:black"> </span></span><span style="font-size:13.0pt;color:black"><br>
</span><span class="xnormaltextrun"><span style="font-size:13.0pt;color:#404040">202.897.0028 |
</span></span><a href="mailto:slee@NASTAD.org" target="_blank"><span class="xnormaltextrun"><span style="font-size:13.0pt">slee@NASTAD.org</span></span></a><span class="xscxw125233974"><span style="font-size:13.0pt"> </span></span><span style="font-size:13.0pt"><br>
<span class="xnormaltextrun"><b><span style="color:#008FC5">NASTAD</span></b><span style="color:#008FC5"> </span><span style="color:#404040">|
</span><span style="color:#0072C6">444 North Capitol Street NW, Suite 339 | Washington, DC 20001</span><span style="color:#404040">|
</span></span></span><a href="https://nastad.org/" target="_blank"><span class="xnormaltextrun"><span style="font-size:13.0pt;color:#404040">NASTAD.org</span></span></a><span class="xnormaltextrun"><span style="font-size:13.0pt;color:#404040"> </span></span><span class="xscxw125233974"><span style="font-size:13.0pt;color:#404040"> </span></span><span style="font-size:13.0pt;color:#404040"><br>
<br>
</span><span style="mso-ligatures:none"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="mso-ligatures:none"><o:p> </o:p></span></p>
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<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Verdana",sans-serif;color:black"><o:p> </o:p></span></p>
<p class="MsoNormal"><b><span style="font-size:14.0pt;color:black">Shelley Pearson</span></b><b><span style="font-size:14.0pt;color:black;mso-ligatures:none"><o:p></o:p></span></b></p>
<p class="MsoNormal"><i><span style="font-size:14.0pt;color:black">Pronouns: she/her/hers
<o:p></o:p></span></i></p>
<p class="MsoNormal"><span style="font-size:14.0pt;color:black">HIV/STI Administrative and Communications Specialist<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt;color:black">OREGON HEALTH AUTHORITY
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt;color:black">Public Health Division<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt;color:black"><a href="mailto:shelley.m.pearson@dhsoha.state.or.us">shelley.m.pearson@oha.oregon.gov</a>
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt;color:black">Phone: 503-381-6173<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt;color:black">Fax: 971-673-0178<o:p></o:p></span></p>
<p class="MsoNormal"><span style="color:black"><o:p> </o:p></span></p>
<p class="MsoNormal"><a href="http://www.endhivoregon.org/"><span style="mso-ligatures:none;text-decoration:none"><img border="0" width="132" height="101" style="width:1.375in;height:1.052in" id="Picture_x0020_1" src="cid:image003.png@01DB3B66.63788F70"></span></a><u><span style="color:#0563C1"><o:p></o:p></span></u></p>
<p class="MsoNormal"><span style="color:black"><o:p> </o:p></span></p>
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