CMS issued a final national coverage determination (NCD) stating that for claims with dates of service on or after Sept. 30 (the date CMS issued the NCD), pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV is covered as an additional preventive service, and is appropriate for individuals entitled to Medicare benefits under Part A or enrolled under Part B. CMS also covers furnishing HIV PrEP using antiretroviral drugs, including the supplying or dispensing of these drugs and the administration of injectable PrEP.
CMS stated that payment and coding specifics will be addressed in the implementing instructions given to Medicare contractors.
For individuals being assessed for or using PrEP to prevent HIV, CMS covers all the following as an additional preventive service: a) 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); b) Up to eight HIV screening tests every 12 months; and c) A single screening for hepatitis B virus.
In response to concerns from NCPA and others about administrative burden that the transition from Part D to Part B coverage would entail, CMS stated that it published a webpage containing additional resources, hosted office hours, and encouraged pharmacies and other affected parties to prepare for this transition. The website includes a fact sheet for pharmacies, recommending that those not already enrolled as a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier should enroll as a Part B Pharmacy, which has a lower level of burden and cost, is different than enrolling as a DMEPOS supplier, and has a different forms for enrollment (CMS-855S for DMEPOS suppliers versus form CMS-855B for Part B Pharmacy suppliers). Additionally, the website contains a “Technical Frequently Asked Questions for Pharmacies” document to provide more information for submitting future Medicare Part B claims for PrEP for HIV. CMS also issued a memo to communicate the transition to coverage of the oral PrEP drugs from Medicare Part D to Part B to the Medicare Advantage organizations and Part D plan sponsors. CMS engaged and coordinated outreach efforts with the Medicare administrative contractors for this change.
Commenters including NCPA had asked CMS to recognize the significant role that pharmacists play in making PrEP available and recommended that CMS expand coverage to include payment for services of pharmacists, including initiating PrEP and administering PrEP and related services, such as office visits and counseling, according to their state’s pharmacist scope of practice laws. Also, commenters including NCPA asked CMS to explicitly include pharmacists as one of the health care practitioners mentioned in the NCD text. In response, CMS stated that pharmacists are not recognized Medicare providers or suppliers and are not eligible to be paid directly for furnished services, and that pharmacists may provide, when all conditions are met, services as auxiliary personnel “incident to” a physician’s or other practitioner’s service in certain settings.
