Originally published Jan. 27.
By Turna Ray
A bill introduced in the New York State Assembly would require insurance companies to cover genetic testing to gauge cancer susceptibility for those deemed by doctors to be at high risk of getting the disease based on family history. The bill, introduced by New York Assemblyman J. Gary Pretlow, is broad in its scope, and doesn't curry favor with insurers during a time when payors are becoming increasingly serious about reining in unnecessary testing.
The bill (No. A02325) would amend the current insurance law in New York by requiring accident and health insurance polices to "cover the cost of genetic testing [for a] person with a family history of cancer when the attending physician determines [the] person has a significant risk" for getting the disease.
A person with "significant risk" of cancer is defined in the bill as someone who has a family history of cancer, where more than one generation has had the disease; the person has a family member who has had more than one occurrence of the disease; or the person has a family member less than 45 years of age who has been diagnosed with the disease.
Although the text of the bill doesn't specify what type of cancer susceptibility testing it seeks to mandate coverage for, a memo accompanying the bill notes that that purpose of the proposed legislative mandate is to require "insurance companies to cover genetic screening and counseling costs incurred by patients determined to be at 'significant risk' of the development of breast cancer."
Then, the memo goes on to cite the example of BRCA1 and BRCA2 mutation testing as "justification" for the bill. BRCA1 and BRCA2 "mutations account for 33 percent of all early-onset breast cancer and may be detected early through genetic screening," the memo states. "Currently, screening for such mutations is conducted by the simple withdrawal of a minimal amount of blood. We feel that by offering this test to more patients through insurance coverage, the cost of the test as well as that of follow-up counseling will be significantly decreased."
Mandated coverage for this type of cancer susceptibility testing would save insurers money, the sponsor of the bill believes. "Due to the exorbitant cost of retroactive treatment for breast cancer, we feel this bill will not only save costs in proactive treatment but will also save lives," the memo says.
However, insurers that PGx Reporter spoke to believe that broadly covering medical procedures via state mandates, without evidence that the intervention is cost effective and clinically useful, would lead to unnecessary procedures and cost hikes for consumers.
"We would encourage the NY state legislature to consult with the American Society of Clinical Oncologists or the National Cancer Care Network to carefully align this proposed legislation with the best available science and clinical guidelines so as not to pass a law that could lead to a dramatic overuse of these tests, bringing both needless worry to consumers and needless expense to the healthcare system — with virtually no impact on the quality of care available to New Yorkers," said a spokesperson from the national insurer Aetna.
The bill has been read once and been referred to the NY State Assembly's Committee on Insurance. The materials posted about the bill on the state assembly website do not suggest that it is up for a vote.
Pretlow, a Democrat representing the 87th district in the New York State Assembly since 1992, previously attempted to introduce a similar insurance mandate for cancer susceptibility genetic testing. During those prior attempts, employer and insurance groups similarly raised concerns that such a broad coverage requirement would raise healthcare costs, not lower them.
Citing figures from the Employer Alliance for Affordable Health Care, Aetna noted that the incremental build-up of coverage mandates over two decades has led health insurance costs for New Yorkers to be 25 percent higher than the national average.
"With more than 30 benefits currently mandated in New York, the average family in New York pays more than $1,000 per year to cover the cost of these mandates, and there are over 100 new mandates proposed every year," the Aetna spokesperson said. "As an unintended consequence, mandates make health insurance more expensive, leading more New Yorkers to drop out of insurance plans because the cost, even when shared with their employer, is too high."
Similarly, Susan Pisano, VP of communications at the payor interest group America’s Health Insurance Plans, told PGx Reporter that in general, the insurer community "has not been supportive of bills that mandate coverage for specific benefits in the states." In AHIP's view, the process of building benefit packages by state mandates doesn't take evidence into account — namely, whether the intervention improves outcomes, whether there are support services in the region, whether there are available treatments for those whom testing indicates need treatment, and whether the procedure is cost effective.
"Health plans would want to focus on tests for which there is evidence" supporting their use, Pisano stated. When considering whether to cover a genetic test, health plans look to see that the test meets some basic criteria, such as whether it is clinically validated, whether there is genetic counseling available, and whether there is a clinical basis for gauging who needs the test.
It is unclear from the text of the bill what economic analysis supports the current iteration of Pretlow's legislation. Furthermore, if the bill seeks to cover genetic testing for cancers other than breast cancer, data on the effectiveness and usefulness of these tests will also be needed to bolster the bill's chance of passage. Despite numerous attempts, Pretlow was unavailable for comment.
AHIP's Pisano noted that very few genetic tests have economic analysis suggesting that they save the healthcare system money. Cost savings estimates "would vary according to the test and the disease," she noted.
When it comes to BRCA mutation testing to gauge hereditary risk of breast and ovarian cancer — the only genetic test specifically mentioned in Pretlow's memo accompanying the bill — there is sufficient clinical utility data to suggest that the intervention is useful in identifying women at high risk for getting these types of cancers. However, it is also well documented that women are over-tested or unnecessarily tested for these mutations even when there is no family or medical history to suggest they are at high risk for cancer.
Several insurers, including Aetna, have reported that around 20 percent of requests for BRCA testing within their systems do not meet professional society guidelines for hereditary breast and ovarian cancer screening (PGx Reporter 11/04/09). As a result, many insurers require prior authorization of BRCA mutation testing, in which they will cover the cost of the test only when the person's medical and family history suggests the test is medically necessary according to guidelines from professional medical societies.
Cancer screening guidelines, issued in March 2009 by the American College of Obstetricians and Gynecologists, recommend OB-GYNs to routinely screen their patients for hereditary breast and ovarian cancer risk. The guidelines specifically advise OB-GYNs to conduct the initial screening evaluation by asking questions about personal and family history of breast cancer and ovarian cancer. After this general evaluation by the OB-GYN, however, ACOG advises doctors to send those patients who may be at higher risk to genetics experts for a more in-depth evaluation.
If it is deemed through the prior authorization process that BRCA testing is medically necessary for a woman, then those insurers are also providing genetic counseling services.
"In the absence of mandates, and in accordance with good science and good medicine, Aetna already has led the industry in recognizing the importance of genetic medicine and in promoting and covering access to medically appropriate genetic services," said the spokesperson from the insurance company. "We also have pioneered services that use genetic information to improve the quality and cost effectiveness of medical therapy, as well as programs to educate members about genetic testing and make genetic counseling more readily available to them."
Aetna is studying BRCA testing patterns throughout the US in a collaborative study with Georgetown University, University of South Florida, and the American Cancer Society. Last year, Aetna said it will review de-identified data on 13,000 of its members who have received BRCA testing in order to gain greater understanding of how physicians are making testing decisions and figure out whether access to such tests is limited for women from lower socioeconomic and minority groups. Additionally, the study will examine the how readily women use risk-reduction and screening services after testing (PGx Reporter 09/22/10).
In the end, Pretlow's mandate may be superfluous since most insurers, even with prior authorization schemes in place, appear to cover most of the BRCA tests performed by doctors. Myriad claims that as much as 96 percent of its revenue is paid by insurance companies, and 4 percent is paid by private individuals. On average, Myriad has said that insurers reimburse for approximately 92 percent of the $3,340 list price for BRACAnalysis.
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