UnitedHealth Draws Fire on Truvada Policy

UnitedHealthcare recently took heat on a coverage policy for Gilead’s HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) that patient rights groups said was designed to steer HIV or potential HIV patients away from joining — or staying — in their plan. This growing pattern of requiring preauthorization (PA) every three months for Truvada among some health plans — along with placing HIV, multiple sclerosis (MS) and other costly drugs and their generic equivalents on the highest tier — is drawing more attention. The Affordable Care Act (ACA) has discrimination protections for patients, but if these should be repealed, advocacy groups say they have other outlets for recourse that they are turning to as the complaints roll in. UnitedHealthcare’s quick reversal of its July 1 policy could be an indication that there are some teeth in activists’ efforts, so health plans might want to rethink their policies.

UnitedHealthcare is not the first or only health plan to require PA for Truvada, an HIV prevention and treatment medication, but it may be among the first to change course so quickly over pressure from patient rights groups. Industry insiders see this trend only growing.

On July 1, the UnitedHealth Group unit instituted a policy that made getting Truvada much more difficult, if not impossible, in addition to humiliating for its members, according to the AIDS Institute in Washington, D.C. The policy required PA every three months for Truvada for pre-exposure prophylaxis (PrEP) to prevent HIV, an indication for which it is considered to be highly effective. The plan also required the medication to be acquired only through mail order, in violation of the ACA, the institute says. That’s why, when OptumRx, UnitedHealth’s PBM subsidiary, sent a letter to a member denying coverage, it drew ire and sent the member to the AIDS Institute for help.

The institute’s copy of the OptumRx letter reads: “Your request for coverage for Truvada is denied. This decision is based on health plan criteria for Truvada. The information you sent in shows you are taking this medication for high risk homosexual sexual behavior. This medication is only covered if you have HIV Infection, Post exposure prophylaxis (PEP) to reduce the risk of acquisition from either an occupational or non-occupational known or suspected possible exposure to HIV, Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk or Hepatitis B and meet indications specific criteria. You do not meet any of these criteria.”

The institute and 13 other patient rights organizations wrote to UnitedHealthcare, complaining that the new policy required “invasive personal information” for PA and violated ACA non-discrimination provisions. National media coverage ensued.

United updated its website within hours of receiving the letter, according to Carl Schmid, deputy executive director of the AIDS Institute: “We apologize for the insensitive language appearing in the letter and regret any difficulty it caused. We have corrected our letters, removed the prior authorization requirement for Truvada and members can fill their prescription at the network pharmacy of their choice.”

Schmid tells AIS Health that he has not seen other health plans require such an “invasive discriminatory” PA for Truvada when using the drug as a PrEP. “This was so egregious and stigmatizing,” he says. “Here we are trying to prevent HIV and if someone wants to be on Truvada and their plan covers it and if their provider prescribes it, plans should make it easy to access the [prescription].”

Craig Pulsipher, state affairs specialist, government affairs, at AIDS Project Los Angeles (APLA), says physicians have reported similar problems with approvals for PrEP at other health plans. “We will certainly be following up,” he says.

The institute and other groups are calling for action from the HHS Office for Civil Rights (OCR), state insurance commissioners and attorneys general to act, Schmid says. They have won such battles in the past.

Industry groups agree that affordability is another disturbing issue. “Insurers are increasingly using utilization (e.g., prior authorization), high deductibles, coinsurance and multiple cost sharing tiers, which result in high cost sharing and limited access for some patients,” says spokesperson Holly Campbell, for the Pharmaceutical Research and Manufacturers of America (PhRMA). “Insurance coverage should provide patients with access to high quality medicines and not discriminate against patients with chronic conditions such as cancer, HIV and multiple sclerosis.”

Amy Killelea, an attorney and the director of health systems integration at the National Association of State and Territorial Apprenticeship Directors (NASTAD), which represents officials who administer HIV programs, says her group has seen health plans restrict access to HIV medications. “This has included plans not covering single tablet regimens that improve adherence, placing all or most HIV medications on the highest cost-sharing tiers, or employing excessive prior authorization requirements on HIV medications,” she says.

NASTAD issued a report last year that reveals “pervasive deficiencies” in marketplace plans’ coverage and pricing of HIV medications and “highlights the direct relationship between drug prices and insurer restrictions.” NASTAD says it has shared the report with CMS.

“For PrEP, we have seen an uptick in some access restrictions, but the UnitedHealthcare requirements were the most egregious,” Killelea says. There have been “numerous complaints filed under the ACA’s non-discrimination protections citing discriminatory plan designs that effectively bar people living with HIV from access to lifesaving medications,” she says. “The AIDS Institute and NHeLP [the National Health Law Program] filed a complaint in Florida and with the OCR [i.e., HHS Office for Civil Rights], and the Center for Health Law and Policy Innovation at Harvard Law School has filed a dozen complaints with OCR that are still pending.”

Despite the non-discrimination protections under ACA, plans still have “a great deal of discretion” in the area of utilization management that they can use to restrict coverage, according to Killelea.

NASTAD applauds UnitedHealthcare’s “swift reversal of what was clearly a discriminatory policy not in line with public health best practices,” she says, adding that NASTAD hopes that state and federal regulators take note. “We hope that other issuers review their policies to ensure they are reflective of both federal HIV treatment guidelines and CDC PrEP guidelines.”

“The ACA’s protections explicitly prohibit issuers from employing plan design features — including prior authorization requirements — that bar people living with high-cost conditions from access,” she says, “and if these practices continue, we will continue to see federal complaints submitted to OCR and to state insurance regulators.”

Attorney Katie Keith, a steering committee member for the group Out2Enroll, a national organization that focuses on health insurance outreach and education for the lesbian, gay, bisexual and transgender community, says the incident with United “could violate” the protections in Section 1557 of the ACA. “If a plan had maintained this type of denial, we would urge a consumer to vigorously appeal the decision with their insurer and through external review, as well as file a complaint with their state insurance department,” she says.

Keith adds that although other insurers do not appear to be citing sexual orientation as a reason for denial, Out2Enroll has noticed an increase in utilization management restrictions being placed on Truvada, as well as other drugs used to treat HIV. “This is of great concern because it imposes additional barriers that patients may not be able or willing to jump through, ultimately reducing drug adherence and raising the risk of HIV transmission. It means that we lose Truvada as a significant tool that we need in the fight against HIV.”

Adapted from the 8/14/17 issue of AIS’s Health Plan Week.