California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia and syphilis—which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on COVID-19.
The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.
By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care and give them more control over their health, say experts on infectious diseases.
“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”
But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network healthcare providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.
Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan, D-Sacramento, a pediatrician who wrote the law.
“We have children born in California with syphilis,” Pan said. “You’d think that went away in the Victorian era.”
Even before COVID, sexually transmitted infections hit all-time highs in the U.S. and California (PDF) for six years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.
The pandemic only worsened the problem because health departments were overwhelmed responding to the COVID emergency, and stay-at-home orders kept people away from clinics.
In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents—up to 78% in one survey (PDF)—have diverted some of their STI workforces to test and monitor COVID. A report that accompanied the most recent survey found that some STIs were “completely unchecked” due to reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.
Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus or penis.
Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.
Ivan Beas, a 25-year-old graduate student at UCLA, was getting tested frequently as part of a two-year research study. When clinics closed during the pandemic, researchers sent him a home kit.
The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea and trichomoniasis, was packaged discreetly and came with easy instructions. It took Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.
Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.
The last time he went to a clinic in person, “I spent two hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.
“If insurance were to cover it, I’d definitely do it more,” he said.
Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a healthcare provider.
Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests—if anything—depends on the type of plan they have, whether their provider is in-network, and if they fall into a category the federal government has designated for free screening.
Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.
The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.
The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.
Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.
Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.
Charlotte Gaydos, co-founder of the project, said that requests for test kits during the pandemic nearly tripled—and that she would expand to every state if she could bill insurance the way the California law mandates.
The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.
Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.
Vlad Carrillo, 31, experienced such trade-offs recently. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about seven hours away to Bishop, the only incorporated city in rural Inyo County.
“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.
Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.
“Going without it for so long was really hard on me,” Carrillo said.
https://www.fiercebiotech.com/medtech/sexually-transmitted-infections-off-charts-california-pushes-at-home-tests
