Despite federal rules, HIV prevention drug still comes with costs

The billing errors have forced some to stop taking the medicine, putting them at heightened risk of contracting the virus.

Henry Henderson was billed more than $200 every three months for a medication he should have received free of charge.Craig F. Walker/Globe Staff

For more than two years, most insurers in Massachusetts and across the country have been required to cover — for free — a medication that reduces the risk of contracting HIV, now a largely preventable virus. But several patients and advocates interviewed by the Globe said insurers have rejected such claims, forcing them to pay out of pocket or stop taking the drug..

“It’s like an extra month of rent,” said Henry Henderson, a 36-year-old from Somerville. “It incentivizes me to think, do I really need to do this?”

Henderson has been charged between $100 to $300 almost every three months since 2020 for his daily oral HIV pre-exposure prophylaxis (PrEP) medication.

The bills, for doctor’s visits and quarterly lab tests, have come despite regular communication with his physician’s billing office and calls to his insurer, Tufts Health Plan. He tried filing a complaint with the state’s Division of Insurance, but the agency informed him his insurer wasn’t doing anything wrong.

Advocates say that several insurance companies are flouting mandates that grant most commercially insured patients free access to PrEP drugs, which reduce the risk of getting HIV from sex by about 99 percent and from injecting drugs by at least 74 percent when taken as prescribed, according to the CDC.

“We don’t want to put up any barriers to people accessing PrEP,” said Carl Schmid, executive director at HIV + Hepatitis Policy Institute. “People want to be on PrEP for a reason. They feel they could be vulnerable.”

Despite initially contesting Henderson’s claim with the Division of Insurance, Point32Health, the parent company of Tufts, said in a statement to the Globe that it had billed him in error.

“After conducting research into this particular issue, we discovered the claim submitted by the member’s provider was not billed in accordance with our preventive services policy,” the statement said. Point32Health pledged to work closely with Henderson’s provider to make sure the issue didn’t happen again and said it would refund Henderson for the costs he incurred.

Point32Health added that it would implement a “comprehensive review” to ensure that such billing has not occurred in other instances and would do more to educate providers about its policy.

The first drug for HIV PrEP was approved by the FDA in 2012. The daily oral pill is for those at high risk of getting HIV, including those who have a partner with HIV, inject drugs, or do not consistently use a condom.

Several states including California, New York, and Colorado saw the promise of PrEP and mandated insurers provide it without cost. In 2019, the Preventive Services Task Force gave daily oral PrEP an “A” grade, which qualified it for full coverage under the Affordable Care Act.

The task force is currently accepting public comment on its updated recommendations, including an “A” grade for injectable PrEP, which is administered every two months and was approved by the FDA in December 2021.

PrEP coverage mandates don’t apply to Medicare, and while MassHealth covers PrEP without cost in Massachusetts, other states’ Medicaid programs are not as comprehensive.

Though oral PrEP coverage requirements were in effect by January 2021, insurers were slow to adopt the policy. The Biden administration published new guidance six months later, further emphasizing that insurers must cover all the costs associated with PrEP — not only the medication itself but also the required quarterly testing for HIV and sexually transmitted diseases; kidney function and other blood tests; and regular doctor’s visits. The Departments of Labor, Health and Human Services, and Treasury said they would wait 60 days before taking action against insurers, to make sure payers had the time to come into line.

Over a year has passed, and patients say they are still encountering problems. The HIV + Hepatitis Policy Institute, which is headquartered in Washington, D.C., said they have heard from several patients in Massachusetts who received bills and subsequently stopped taking PrEP. The institute receives funding from Gilead Sciences and Viiv Healthcare, the makers of PrEP drugs, though the organization said that its policies were its own and that it represented patients.

Hundreds of people are newly diagnosed with HIV in Massachusetts annually, despite the tools to combat it. In 2020, the latest year for which data is available, over 23,000 people in the state were living with HIV, 63 percent of whom were “virally suppressed,” meaning they were not able to transmit the virus thanks to antiretroviral medication.

“We have an epidemic out of public view,” said Dr. Kenneth H. Mayer, medical research director at Fenway Health and co-director of The Fenway Institute. “We are still having over 35,000 new HIV infections [in the U.S.] a year when it’s totally preventable. That’s a tragedy.”

Mayer said Fenway has written more than 5,000 PrEP prescriptions, and 3,500 of the clinic’s patients have active prescriptions.

Programs exist to help individuals with any costs, including the Massachusetts Pre-Exposure Prophylaxis Drug Assistance Program. Websites such as PleasePrEPMe.org can help patients find doctors who will prescribe the drug, and there are online telehealth companies such as MISTR that provide no-cost access to PrEP via telehealth and help patients navigate patient assistance programs to ensure no out-of-pocket costs.

“If you can navigate the system, most people can get most things covered, but they don’t make it easy,” Mayer said.

Daniel Osofsky, 24, received his initial prescription without much of a problem but was billed more than $300 for a quarterly follow-up visit and lab tests.

Despite filing complaints with his doctor, his doctor’s billing department, his insurer — Blue Cross Blue Shield of Massachusetts, and the Division of Insurance, the bills remained.

The lab soon began sending letters demanding Osofsky pay his bills, even prohibiting him from accessing further tests at one visit because of his outstanding balance.

Finally, when he received notice that the bill from his doctor had gone to collections, he tweeted at Blue Cross Blue Shield of Massachusetts CEO Andrew Dreyfus. A few weeks later, Osofsky received a letter referencing the tweet, saying his charges had been dismissed and blaming the way his doctor had coded for the visits, though his doctor said he and his office had worked repeatedly with his insurer to code the bill properly.

“I was off PrEP for a while this summer…and I delayed getting back on it because I was so worried about this insurance process,” he said.

Blue Cross Blue Shield said in a statement that it was compliant with all federal mandates regarding PrEP, but inaccuracies in how providers code and bill can sometimes lead to errors.

“We believe statewide guidance would be helpful for clarifying how providers should code these services, and we expect such guidance to be issued in the new year,” said Michael Caljouw, vice president of government and regulatory affairs for the insurer. “In the meantime, we encourage any BCBSMA members who feel they may have been billed incorrectly for services related to PrEP to contact us so we can assist.”

Jeffrey Schaffer, program manager for sexual health at Outer Cape Health Services said he proactively tells people to reach out to the clinic if they encounter billing problems.

But cost is only one barrier to providing PrEP to at-risk populations. Schaffer said that some doctors refuse to prescribe the medication, telling patients they should just use condoms. The clinic helps counsel patients about ways to talk to their doctors about prescribing PrEP. They also help what is sometimes a tourist population in Provincetown access the medication while they are there.