By Melissa Patrick
Kentucky Health News
A bill to require private and public insurance plans in Kentucky to cover biomarker testing for cancer and screenings for genetic-based reactions to drugs has been posted for passage Tuesday in the state House.
The House Health Services Committee unanimously approved House Bill 180 Feb. 16. It is sponsored by committee chair Kim Moser, who said “We know that these biomarker and pharmacogenetic tests are evidence-based. They are standards of care for many cancer patients and others and they must be medically necessary in order to be prescribed. But the insurance coverage is failing to keep pace.”
Pharmacogenetic testing determines how a patient will respond to a medication. Biomarker testing “is a way to look for genes, proteins, and other substances (called biomarkers or tumor markers) that can provide information about cancer. Each person’s cancer has a unique pattern of biomarkers,” says the National Cancer Institute.
Kentucky ranks among the bottom 10 states for biomarker testing coverage, with 42 states having better access to such testing, according to Moser.
“House Bill 180 is about getting the right medical treatment at the right time, saving precious time, saving healthcare costs and saving lives,” Moser said. “This testing allows for precision or targeted treatment, less trial and error and of course less of the devastating side effects that we see and premature death.”
The American Cancer Society estimates that more than 10,000 Kentuckians will die from cancer this year and 30,000 will be diagnosed with it. “Having access to insurance-covered biomarker testing gives them the best chance of survival,” the society said in a press release.
Moser said the bill will require all private insurance plans, Medicaid and the state-employee health plan to cover the biomarker and pharmacogenetic tests when they are medically necessary.
Moser said the lack of consistent insurance coverage “especially affects the minority populations, Medicaid-eligible populations, and rural populations, where there’s less access to this care.”
Dr. Michael Gieske, a family practitioner at St. Elizabeth Healthcare in Northern Kentucky and the director of the hospital’s lung-cancer screening program, said biomarker screenings for people with lung cancer can make a big difference. He said 55% of people with lung cancer don’t meet the current screening criteria and many of this group would respond to precision medicine and targeted therapies, which first requires a biomarker test to determine.
“This treatment can be miraculous,” Gieske said. “We have patients that are 5, 10, 15, even 20 years out of their cancer diagnosis with late-stage lung cancer . . . . They have no evidence of disease and most of those patients are able to say that because of targeted therapies, because they had biomarker testing.”
He added, “These are medical advances that need to be embraced, they need to be available for all individuals, they should not be available for some and not others.”
Lung-cancer screening with an annual low-dose CT scan is recommended for adults aged 50 to 80 who have smoked at least 20 “pack-years” (a pack-year amounting to one pack of cigarettes a day for a year, or an equivalent amount, such as half a pack a day for two years) and either still smokes or has quit within the last 15 years.
Biomarker success stories
Leah Phillips, a stage 4 lung-cancer survivor from Oldham County, told the committee that she was diagnosed with the disease in 2019 as a healthy nonsmoker at the age of 43, and told she had a life expectancy of six months to a year.
On the recommendation of her oncologist, Phillips had a biomarker test that found one of her genes had stopped working, allowing the lung cancer to grow. There was a targeted therapy to treat that type of cancer.
“Had I not had the biomarker testing done, I would have just been treated like a typical lung-cancer patient, most of which are smokers, and been put on chemotherapy and immunotherapy,” Phillips said. “If I would have chosen that route of treatment my life expectancy and my quality of life would be much decreased. . . . So not only is this important in guiding my treatment plan but it’s also allowed me now to live for 38 months since diagnosis with now the life expectancy of five to seven years.”
|Boyd “Bo” and Brandy Rowe |
After the meeting, Boyd “Bo” Rowe of McCreary County told Kentucky Health News that he was diagnosed with stage 4 lung cancer in 2020 as a nonsmoker at the age of 41. He said the cancer had spread to his liver, hips, spine, ribcage and brain and he had a life expectancy of six months.
He said his biomarker test found a rare form of cancer called ALK-positive that could only be treated with a targeted therapy. He added that doctors didn’t even know about ALK-positive lung cancer 10 years ago and the medicine to treat it has only been around for five years. Rowe said he takes eight pills a day and will for the rest of his life, but his last scan showed 90% of the cancer that had been detected is no longer detected.
“Without the biomarker, you know, there would be a tombstone with my name on it,” he said. “I wouldn’t have been able to get the treatment that I’ve gotten, which insurance has paid for — but they didn’t pay for the [biomarker] test that allowed for the targeted treatment that I need.”
Tom Stephens, president of the Kentucky Association of Health Plans, said the lobbying group doesn’t oppose the bill, but wants to “make sure that there are appropriate guardrails on the legislation so that it isn’t misapplied.” He said the group is concerned that the mandated coverage will “significantly increase” the number of tests that insurers are required to cover, including tests that have not been found to improve health outcomes.
“Broad testing leads to unnecessary testing, raising costs and lowering affordability for all enrollees,” Stephens said.
He also noted that the bill’s fiscal-impact statement did not include Medicaid or the state-employee health plan. The statement
, from the Kentucky Department of Insurance
, said it did not expect the bill to materially increase premium or administrative costs for fully insured health plans.
Stephens asked the committee to delay consideration of the bill to consider those estimated impacts and his group’s proposed amendments.
KAHP lobbyist Scott Brinkman said one amendment would limit testing to detecting signs of cancer or a cancer-related health condition. “We also want to make clear that there has to be a medical necessity for the test,” he said, as well as a narrow definition of medical necessity and a later effective date: January 2025 instead of January 2024.
Moser said after the meeting that resistance to her bill has largely been about the “guardrails” around when the testing is required.
“I’ve done a lot of work with the insurance companies to date and I’ll continue working with them on their concerns,” she said. “But you know, I think that we’ve tightened this down to their specifications.”
In mid-February, Kentucky Health News asked Doug Hogan, the cancer society’s state-government relations director, about the costs associated with biomarker testing. “The cost really depends on the test and who is paying for it,” he wrote. “Single-gene tests will be far less expensive than more comprehensive testing, but could also require multiple biopsies and multiple tests. A recent actuarial analysis found that the average cost to insurers per biomarker test in the private market was $224, and the average cost in the Medicaid market was $78.71. However, a patient forced to pay out of pocket for a biomarker test that wasn’t covered would be much more than this.”
Kentucky Health News is an independent news service of the Institute for Rural Journalism and Community Issues, based in the School of Journalism and Media at the University of Kentucky, with support from the Foundation for a Kentucky