NEW YORK – Nonspecific language in California Gov. Gavin Newsom's recent veto of a bill aimed at mandating automatic insurance coverage of biomarker tests supported by medical and scientific evidence, caused confusion among the bill's proponents, prompting concern from at least one sponsor that those opposed to it had misunderstood certain parts of the legislation.
Specifically, Newsom wrote in a statement explaining his veto of the bill, SB 912, "would require the Department of Health Care Services to cover biomarker testing supported by local coverage determinations, which can contradict each other, and tests supported by 'nationally recognized clinical practice guidelines and consensus statements,' which may not be evidenced-based."
Adara Citron, principal analyst at the California Health Benefits Review Program (CHBRP), who led that program's analysis of the bill and the impact it would have if passed, suggested that the governor was drawing attention to the need to be "incredibly specific" in legislative language.
"One of the challenges with [SB 912] is there could be several different consensus statements published by different organizations, and they could contradict each other, and they could contradict what [payors] have already decided to use internally," said Citron.
Citron said that she and colleagues had found that most health insurance companies in California already cover biomarker testing where it is medically indicated and backed up with supporting evidence.
Without introducing changes to benefits and coverage she said, "is the additional regulation really necessary?"
However, Autumn Ogden-Smith, the director of California state legislation for the ACS CAN, which sponsored the bill, refuted this claim, stating "our bill clearly defined what the nationally recognized clinical practice guidelines are, and it also defines what consensus statements are," adding that "nothing in this bill requires coverage of any tests that are not evidence based."
In a response to the governor's veto, ACS CAN called attention to the fact that SB 912 defines "nationally recognized clinical practice guidelines" as "evidence-based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and are subject to a conflict-of-interest policy."
Similarly, the bill defines "consensus statements" as "statements developed by an independent, multidisciplinary panel of experts who utilize a transparent methodology and reporting structure and are subject to a conflict-of-interest policy."
Ogden-Smith expressed concern that California's Department of Health Care Services, one of the bill's opponents, may have incompletely understood portions of SB 912, saying that it was "a little surprising" that the department didn't want to apply the same guidelines used by the Centers for Medicare and Medicaid Services (CMS), preferring instead to rely upon a "gold standard" of guidelines from the National Academy of Medicine, upon which the governor said in his statement that Medi-Cal policy is based.
"But there's no gold standard," Ogden-Smith said. "There [are] guidelines. And the national determinations help to ensure that people get equitable access to the appropriate biomarker testing across all insurance types."
Anthony Cava, a spokesperson in the Office of Communications for the DHCS, pushed back however, saying that "'consensus statements' are, by definition, not evidence-based."
Cava pointed to a study published last year in the British Medical Journal that determined that "consensus-based guidelines often produce more recommendations violating the evidence-based medicine principles than evidence-based guidelines."
Cava also noted that while many organizations can claim to be nationally recognized and for their guidelines to be evidence-based, the National Academy of Medicine standard includes recommendations published by the United States Preventive Services Task Force (USPSTF) and the American Society of Clinical Oncology, both of which are used as a reference source for Medi-Cal coverage policy determinations. Furthermore, Cava noted, federal Medicaid law requires states to follow USPSTF recommendations.
Nonetheless, the bill's sponsors point to disparities in comprehensive and affordable biomarker testing access in California that are inadequately addressed by current legislation.
"A lot of Medicare, Medicaid, [and] Medi-Cal patients here in California are less likely to receive standard-of-care biomarker testing that's necessary to best treat their cancer," Ogden-Smith added. SB 912, she said, "is just going to make sure that everybody's receiving equitable access."
A study from the University of California, Davis, for example, found that cancer patients with Medi-Cal are less likely to get recommended treatment and have lower survival rates than patients with other types of insurance.
As an example of uneven test coverage, Ogden-Smith pointed to Guardant Health's Guardant360 liquid biopsy test as one often denied under Medi-Cal. In California, she explained, UnitedHealthcare, Aetna, and Anthem do not cover it, while Medi-Cal sometimes does, but only for non-small cell lung cancer (NSCLC), despite the test's inclusion in the National Comprehensive Cancer Network (NCCN) for eight tumor types.
A peer-reviewed study conducted by Genentech and the ACS CAN and published earlier this year in Future Medicine found most private insurance policies in the US are more restrictive than NCCN guidelines, including 35 percent of California policies related to biomarker tests for breast cancer, NSCLC, melanoma and/or prostate cancer.
Cava, however, noted that NCCN guidelines can sometimes conflict with USPFTF recommendations, which the groups opposing SB 912 feared would lead to conflict down the road.
"For example," said Cava, "a testing lab requested that DHCS cover a urine test to assess the risk for high-grade prostate cancer routinely for the general population. The lab cited National Comprehensive Cancer Network, a 'nationally recognized clinical practice guideline' that recommended the test under a consensus recommendation. However, this recommendation conflicts with the USPSTF's recommendation for prostate cancer screening."
In cases like this, opponents felt unsure how coverage mandates would be regulated under SB 912.
Opposition to the bill came from three trade organizations representing insurers and health plans, and from California's Department of Finance.
The trade groups America's Health Insurance Plans, the Association of California Life and Health Insurance Companies, and the California Association of Health Plans, wrote in a Senate floor analysis that biomarker testing is a broad category and includes some tests "that are still classified as experimental."
Although the term "experimental" carries a negative connotation, it is nonspecific. As one regulatory and reimbursement expert who was not involved in SB 912 explained, speaking on background, many tests that lack strong evidence of clinical utility and could be considered experimental may still be included in clinical guidelines.
That same expert explained that while CMS does not cover "experimental" tests per se, except under "coverage with evidence development" (CED) or similar structures, it was unclear upon reading the bill what would be acceptable under its criteria of "nationally recognized clinical practice guidelines and consensus statements." The expert further pointed out that the quality and rigor of evidentiary review of guidelines and consensus statements can vary significantly from one organization to another, noting that "the devil is in the details."
CED is a vehicle by which Medicare, after a formal review of medical literature, "covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data."
The Department of Finance wrote that it opposed SB 912 mainly because the bill would create costs that the department hadn't accounted for in the current state administration's spending plan. While CHBRP noted in its analysis that the bill would likely lead to increased insurance spending, this could be offset by the lower overall spending on therapy resulting from more efficient, targeted treatment use.
Bills very similar to SB 912 have passed in states including Illinois, Arizona, and Rhode Island, giving the California bill's proponents hope that a better version of SB 912 may pass in the future.
"We are currently working through the channels to determine our next steps," said Ogden-Smith. "A new bill may be in the offering that addresses the concerns of the [DHCS] but we are waiting to hear back from the governor's office and the department to figure out what that means."
In a statement, Sen. Monique Limón, the bill's primary sponsor, also hinted at the possibility of revisiting a bill to expand biomarker testing, although she did not offer details.
"I am proud to have authored bipartisan legislation to improve access to biomarker testing, which will help patients treat diseases like cancer, slow disease recurrence or progression, and lead to a better quality of life," she wrote. "While it was regrettably vetoed, I am grateful for the support of my colleagues and our sponsors the American Cancer Society, Action Network and The University of California. The fight for biomarker accessibility isn't over, and I look forward to working with stakeholders to continue to increase healthcare accessibility."