Merkley Steps Up for Prep Users

Thursday, Oregon’s U.S. Senator Jeff Merkley and Tina Smith
(D-MN) were joined by Senators Chris Van Hollen (D-MD), Elizabeth Warren
(D-MA), Bernie Sanders (I-VT), Tammy Baldwin (D-WI), Edward J. Markey (D-MA),
and Cory Booker (D-NJ) in a letter to AHIP, the trade association representing
health insurance companies. The letter expresses concerns about the continued
practice of unlawfully charging individuals for pre-exposure prophylaxis (PrEP)
medication and related care. 

The Senators’ letter follows a Wednesday court ruling that
further threatens affordable access to PrEP. As the legal process moves
forward, the Senators pressed the health insurance industry to abide by current
law to provide medication and ancillary services without charge. 

“It has been brought to our attention that enrollees in
your members’ health plans continue to be charged for necessary medications and
ancillary services-including provider consultations and laboratory
services-contrary to law and additional federal guidance issued by the
Departments of Labor, Health and Human Services, and Treasury,” wrote the
Senators. “We write to express our deep concern with these erroneous and
unlawful charges, and to request additional information on steps that AHIP is
taking to ensure that its members adhere to federal law and ensure the PrEP
drugs and the full scope of PrEP ancillary services are offered without charge
to enrollees.” 

A 2019 ruling by the U.S. Preventive Services Task Force
(USPSTF) gave PrEP an “A” rating as prevention intervention for
people at risk of Human Immunodeficiency Virus (HIV). This ruling brought PrEP
under section 2713 of the Public Health Service Act, which requires insurance
coverage for services or interventions that have been given an
“”A” or “B” rating from the USPSTF. 

Subsequent guidance, published by the Centers for Medicare
& Medicaid Services (CMS) in July 2021, further clarified their ruling.
Noting that “plans and issuers must cover PrEP consistent with the USPSTF
recommendation without cost sharing,” the ruling goes on to clarify that
PrEP is not just the medication, but also all of its necessary related services
including testing, screening, and provider visits. Despite this ruling and
subsequent clarification, individuals are still being wrongly charged
out-of-pocket expenses relating to their PrEP care. 

“In light of this clear guidance from CMS, we are
alarmed by continual reports that patients are routinely billed, either for
payment-in-full or for cost-sharing practices, related to medically-appropriate
medications and essential services,” they continued. “These costs can
be daunting. HIV advocates and clinical workers across the county have reported
that many patients are unaware that they do not have to pay out-of-pocket for
PrEP and ancillary services, assuming that many of these costs are simply
necessary for being on PrEP medication.” 

The Senators’ letter highlights the inequities in PrEP
uptake across communities at higher risk for HIV-including Black and Hispanic
communities and transgender women-due to limited access to financial resources
needed to cover costs of PrEP and associated medical visits and laboratory
tests, among other factors. 

In light of these concerns, the lawmakers ask the following
questions and request a response from AHIP within 30 days: 

  1. What
    information or guidance is AHIP currently providing to support its members
    in ensuring that their health plans are compliant with federal regulations
    clarifying that PrEP and ancillary services should be available at no-cost
    to patients? 
  2. What
    information and educational materials is AHIP recommending that its
    members supply to enrollees to ensure that patients know that PrEP,
    including its ancillary services, should be provided at no-cost to
  3. How is
    AHIP working with laboratories and health care providers to ensure the
    accurate coding of appointments and services so that enrollees are not
    erroneously billed for these services? 
  4. How is
    AHIP working with its partners to develop a full understanding of the
    scope of the issue, both in terms of the number of individuals impacted
    and the monetary impacts of erroneous bills? 
  5. How is
    AHIP working with its members to resolve issues for beneficiaries who have
    been wrongfully charged for PrEP and associated services in an expeditious

The letter is supported by PrEP4ALL, the HIV+Hepatitis
Policy Institute, the Center for Health and Democracy, and NMAC. 

“Unfortunately we have documented dozens of cases of
insurers still charging patients out-of-pocket fees for PrEP-related care, a
year after CMS and the Department of Labor issued their guidance,” said
Kenyon Farrow, Managing Director of Advocacy & Organizing with
PrEP4ALL.?”Ending the HIV epidemic will require us to ensure everyone with
insurance be able to get PrEP services with no cost-sharing, as the rule
intended. We applaud Sen. Merkley and Sen. Smith’s tireless advocacy on behalf
of patients.” 

“We appreciate Senators Merkley and Smith’s leadership
and all their colleagues desire to ensure that the preventative service
provisions of the Affordable Care Act are properly implemented. Private
insurers must provide PrEP drugs and associated services without patient
cost-sharing. We are receiving too many complaints from PrEP users that this is
not always happening. We trust with this letter insurers will ensure full
compliance,” said Carl Schmid, Executive Director of the HIV+Hepatitis
Policy Institute. 

“While appalling, it’s sadly not shocking to see Big
Health Insurance wrongfully billing enrollees for medications and ancillary
services as part of a PrEP regimen to prevent HIV, despite crystal clear
guidance from the Departments of Health and Human Services, Labor, and Treasury
not to do so,” said Wendell Potter, President of the Center for Health and
Democracy. “We’re grateful for the leadership of Senators Merkley and
Smith for sending this letter, underscoring their understanding of the
effectiveness of PrEP and their compassion for those at risk and their