Medi-Cal Nixes Requirement Barriers for Truvada Access

LOS ANGELES—Last month, in a move that won the deep support of three leading AIDS-prevention organizations, Medi-Cal removed requirement barriers for people on Medi-Cal seeking access to Truvada, the pre-exposure prophylaxis (PrEP) medication that has been shown to reduce the risk of getting the HIV virus by as much as 99 percent if used properly. Previous to the change in policy, doctors were required to complete an authorization request when prescribing PrEP for HIV negative individuals.

Also, according to a press release issued last month by AIDS Project LA, "Medi-Cal patients asking for Truvada could have been asked to meet several conditions outlined in the TAR for 'high risk' individuals. Some of these conditions could have required the provision of condoms and monthly HIV testing—not necessarily real world conditions."

Lauding the decision, APLA added, "Many in the HIV/AIDS community consider PrEP a groundbreaking HIV prevention tool. The authorization request is considered an obstacle for both doctors and patients. With Medi-Cal’s action, doctors will now be able to prescribe the drug for men and women who test HIV negative and indicate that they are 'at risk' of infection through HIV exposure."

According to Medi-Cal data, the majority of people in the state living with AIDS are insured through Medi-Cal, as are 1 in 5 Californians under the age of 65, and 1 in 3 of the state's children. But perhaps more relevant to the Truvada issue, the passage of the Affordable Care Act, combined with California's embrace of the ACA's Medi-Cal expansion provisions, means that Medi-Cal will see its rolls balloon over the next few years, adding as many as 1.2 million more Californians.

“The Medi-Cal ruling is a game changer in HIV prevention,” said APLA executive director Craig E. Thompson. “Appropriate access to PrEP through Medi-Cal provides us with another intervention—along with safer sex and condom use—to reduce the number of new HIV infections.

Medi-Cal’s action also brings "an element of health equity to the program’s low-income beneficiaries,” he added. “Private insurance plans have been covering PrEP for some time, often without prior authorization.”

According to, "The policy change resulted from discussions with Mike Wofford, Medi-Cal’s pharmacy policy branch chief, and representatives from APLA, the L.A. Gay & Lesbian Center and Project Inform. The discussions focused on how well doctors were informed about Truvada, possible side effects associated with long-term use of Truvada such as kidney and bone damage, and community acceptance of Truvada as a tool to help prevent HIV infection."

Removing barriers to Truvada may also have a positive impact on the adult entertainment industry in the state and beyond. Not only may some adult performers and their families be eligible for Medi-Cal coverage, but the publicity surrounding the change in policy by the nation's largest Medicaid program, as well as the subsequent groundswell of support for the decision, reinforces arguments in favor of the use of Truvada by adult performers.

Indeed, on both the gay and straight sides of the adult entertainment industry, the subject of PrEP has been in play for several years, even if it now seems to be coming to a head.

In April, just days before the Medi-Cal announcement, New York-based gay producer Michael Lucas penned an editorial for condemning Michael Weinstein, the president of the AIDS Healthcare Foundation, for dismissing Truvada as a "party drug."

"In this man’s prurient imagination," he wrote of Weinstein, "gays are too busy enjoying their bareback orgies to be trusted with taking a once-daily pill. In his view, gay men using PrEP will stir up a frothy new drug-resistant strain of the virus. What evidence exists that this is a valid scientific concern? None. He has not even credited the fact that this form of prevention might and is being used by responsible gay men regardless of the sexual activity they are engaged in. Mr. Weisnstein’s anti-PrEP position is an extension of his long-standing anti-promiscuity crusade and more importantly his continuation of harmful shame tactics."

This month, founder Peter Acworth also addressed PrEP in a open letter to Weinstein, who was arguing against the drug as long ago as 2012.

"I know you have mixed feelings about PrEP, the new medical regimen that can help prevent HIV transmission," he wrote. "It’s not well-understood yet by performers, but I believe we owe it to the communities we serve to evaluate this on its merits. The fact is, none of the performers you bring to your press conferences would have been protected had AB1576 been passed ten years ago, because no California condom law is going to protect performers during their personal lives, or shooting on unregulated sets overseas. PrEP, if it works as advertised, could do just that. In fact, we’ve recently begun working with HIV and sex worker health organizations to develop an educational program about PrEP specifically targeting adult performers—it would be great if you could be a part of it."

As the state acts to enhance protections for individuals on Medi-Cal by removing barriers (i.e. condoms and testing) to Truvada access, it is simultaneously working to create literal barriers (i.e., AB 1576)  for adult performers through the legal requirement that they use barrier protection (including but not limited to condoms and testing) when having penetrative sex on set.

Does that mean that California is less concerned about the health of Medi-Cal recipients than it is about the health of adult performers? If not, why would it be considering establishing the same requirements for the latter that is has already removed for the former? The explanation that one group is employed would seem to be rather weak, considering the fact that citizens covered by Medi-Cal are among the state's most vulnerable, and are thus dependent upon it for protection.

In related news, the Centers for Disease Control yesterday issued new guidelines titled "Preexposure Prophylaxis for the Prevention of HIV infection in the United States - 2014," that strongly advocates for the use of Truvada.

The report can be found here. The summary reads:

Preexposure Prophylaxis for HIV Prevention in the United States - 2013: A Clinical Practice

Guideline provides comprehensive information for the use of daily oral antiretroviral preexposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection in adults. The key messages of the guideline are as follows:

* Daily oral PrEP with the fixed-dose combination of tenofovir disoproxil fumarate (TDF) 300 mg and emtricitabine (FTC) 200 mg has been shown to be safe and effective in reducing the risk of sexual HIV acquisition in adults; therefore,

* PrEP is recommended as one prevention option for sexually-active adult MSM (men who have sex with men) at substantial risk of HIV acquisition  (IA)1

* PrEP is recommended as one prevention option for adult heterosexually active men and women who are at substantial risk of HIV acquisition. (IA)

* PrEP is recommended as one prevention option for adult injection drug users (IDU) at substantial risk of HIV acquisition. (IA)

* PrEP should be discussed with heterosexually-active women and men whose partners are known to have HIV infection (i.e., HIV-discordant couples) as one of several options to protect the uninfected partner during conception and pregnancy so that an informed decision can be made in awareness of what is known and unknown about benefits and risks of PrEP for mother and fetus (IIB)

* Currently the data on the efficacy and safety of PrEP for adolescents are insufficient.

Therefore, the risks and benefits of PrEP for adolescents should be weighed carefully in the context of local laws and regulations about autonomy in health care decision-making by minors. (IIIB)

* Acute and chronic HIV infection must be excluded by symptom history and HIV testing immediately before PrEP is prescribed. (IA)

* The only medication regimen approved by the Food and Drug Administration and recommended  for PrEP with all the populations specified in this guideline is daily TDF 300 mg co-formulated with FTC 200 mg (Truvada) (IA)

* TDF alone has shown substantial efficacy and safety in trials with IDUs and heterosexually active adults and can be considered as an alternative regimen for these populations, but not for MSM, among whom its efficacy has not been studied. (IC)

* The use of other antiretroviral medications for PrEP, either in place of or in addition to TDF/FTC (or TDF) is not recommended. (IIIA)

* The prescription of oral PrEP for coitally-timed or other noncontinuous daily use is not recommended. (IIIA)

* HIV infection should be assessed at least every 3 months while patients are taking PrEP so that those with incident infection do not continue taking it. The 2-drug regimen of TDF/FTC is inadequate therapy for established HIV infection, and its use may engender resistance to either or both drugs. (IA)

* Renal function should be assessed at baseline and monitored at least every 6 months while patients are taking PrEP so that those in whom renal failure is developing do not continue to take it. (IIIA)

* When PrEP is prescribed, clinicians should provide access, directly or by facilitated referral, to proven effective risk-reduction services. Because high medication adherence is critical to PrEP efficacy but was not uniformly achieved by trial participants, patients should be encouraged and enabled to use PrEP in combination with other effective prevention methods. (IIIA)