Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.
Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every 3 months for lab work and clinic visits.
Luckily for Howard, his doctor at Las Vegas' Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.
"If I hadn't been able to get into the trial, I wouldn't have kept taking PrEP," said Howard, 68, using the shorthand term for "preexposure prophylaxis." Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.
Starting this month, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs then without charging consumers anything out-of-pocket (some plans already began doing so last year).
Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an "A" recommendation by the US Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an "A" or "B" rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.
The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.
In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it's not clear if insurers are required to pick up all those costs.
"Cost sharing has been a problem," said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. "It's not just getting on PrEP and taking a pill. It's the lab and clinical services. That's a huge barrier for folks."
Whether you're shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
Q: How can people find out whether their health plan covers PrEP medications without charge?
The plan's list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.
Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn't owe anything out-of-pocket, no matter which tier they are on.
In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.
But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar's coverage.
Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.
"I acted like a shopper of insurance, just like any person would do," he said. "Even when the information is correct, [it's so] difficult to find [and there's] no uniformity."
It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
Q: Are all three drugs covered without cost sharing?
Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn't require prior authorization by the insurer. But if someone wants to take the name-brand drug, they have to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?
That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have bloodwork every 3 months to test for HIV, hepatitis B, and sexually transmitted infections and to check their kidney function.
The task force recommendation doesn't specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.
"If you've got a high-deductible plan and you've got to meet it before those services are covered, that's going to add up," said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. "We're trying to emphasize that it's integral to the intervention itself."
A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.
There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn't be charged for it.
CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. "CMS intends to contact state regulators, as appropriate, to discuss issuer's compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing," the agency said in a statement.
Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?
If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.
"They'd have to appeal to the insurance company and then to the state if they don't succeed," said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. "Most people don't know to do that."
Q: Are uninsured people also protected by this new cost-sharing change for PrEP?
Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don't benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
Kaiser Health News © 2021
Cite this: Michelle Andrews. Many Health Plans Now Must Cover Full Cost of Expensive HIV Prevention Drugs - Medscape - Jan 06, 2021.