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Proposed Medicare Coverage Criteria for Cancer Genetic Tests Alarm Industry Stakeholders


NEW YORK – Diagnostic industry stakeholders are pushing back against two Medicare administrative contractors that have proposed a host of new coverage requirements for cancer genetic tests, including that their use be supported by evidence within third-party databases and practice guidelines. 

In a letter signed by 44 organizations, including the Association for Molecular Pathology (AMP), the American College of Medical Genetics and Genomics, and the American Clinical Laboratory Association, stakeholders raised concerns that the coverage criteria outlined by Novitas and First Coast Service Options (FCSO) in draft local coverage determinations issued in July would harm Medicare beneficiaries with cancer by hindering their access to genetic tests they need. 

The LCDs are broad and would apply to DNA and RNA, germline and somatic genetic tests used to diagnose cancer, gauge a patient's prognosis, predict the likelihood that a patient will benefit from a specific treatment, or identify therapeutic targets. In the draft documents, Novitas and FCSO also flag multiple tests that they would not cover as medically necessary for cancer patients: Castle Biosciences' DecisionDx-Melanoma and DecisionDx-SCC tests; Pacific Edge Diagnostics' Cxbladder Detect, Enhanced Detect, Monitor, Triage, Enhanced Triage, and Resolve assays; Interpace Biosciences' PancraGen; Clinical Genomics' Colvera; Abbott's UroVysion fluorescence in situ hybridization test; and the University of Pittsburgh Medical Center's ThyroSeq Cancer Risk Classifier and PancreaSeq Genomic Classifier. 

In a public meeting in August, Novitas Medical Director Patrick Mann said that the development of this LCD is "imperative for mitigating risk to Medicare beneficiaries and ensuring they receive only medically reasonable and necessary testing." He noted that "as more [genetic] tests become available, the potential for misuse and/or misunderstanding of tests also increases. In fact, current data and reports indicate Medicare beneficiaries are exposed to genetic testing that is not medically necessary and may negatively affect and harm beneficiaries." 

The US Food and Drug Administration has similar concerns that patients may be receiving tests that may harm them and wants to address this with regulation. On Friday, the FDA proposed its hotly anticipated rules for overseeing tests, including genetic tests, developed in a single lab. Historically, the FDA has largely exercised "enforcement discretion," choosing not to regulate lab-developed tests as long as they meet federal lab standards under the Clinical Laboratory Improvement Amendments. However, as LDTs have become more technically complex and widely marketed, the FDA said it has "evidence of problems associated with these tests" from anecdotal reports it has received, the scientific literature, and news articles. 

"Based on current safety signals, FDA is proposing to phase out the general enforcement discretion approach to help assure that patients are receiving accurate and reliable diagnostic test results regardless of where the tests are made," the agency said in its proposed rule

The new requirements in the draft LCDs from Novitas and FCSO would apply to many cancer genetic tests that are offered as LDTs, as well as some FDA-approved tests. 

Laundry list of complaints

These LCDs have a complicated history, and stakeholders have a laundry list of complaints against Novitas and FCOS, from the way these policies have been drafted without sufficient public comment, to the reliance on third-party databases to support the evidence for covered tests, to requirements around who can order testing. 

In June 2022, the two MACs issued draft LCDs for cancer genetic tests, allowing the public to comment on the coverage terms. In June this year, both MACs released much longer final versions of those LCDs that included coverage terms not in the draft. Industry stakeholders objected that the final LCDs were very different from the drafts and that the public hadn't had a chance to provide feedback. In response, the MACs withdrew those final LCDs in July and re-released them as drafts, allowing stakeholders further opportunity to weigh in in writing or in public. During the public comment period, which ended in early September, multiple stakeholders, including laboratories, oncologists, diagnostic companies, patient advocacy groups, and professional organizations, expressed concerns about the coverage terms. 

A major source of controversy in these LCDs is that the MACs say they won't cover genetic tests that don't have support in one of three third-party databases: the Clinical Genome Resource (ClinGen), the National Comprehensive Cancer Network's compendium or guidelines, or the Memorial Sloan Kettering Cancer Center-sponsored Oncology Knowledge Base (OncoKB). The FDA has recognized ClinGen and OncoKB as databases that test developers can use to support claims about genetic tests for hereditary diseases and cancer in regulatory submissions. Meanwhile, NCCN guidelines readily inform standard practices in cancer care, and payors look to see if an intervention is recommended by the organization when making coverage decisions.

Even though these resources may contain information useful to payors about the clinical validity of a genetic test, stakeholders felt that this can't be the main determinants of whether a test is covered by Novitas and FCSO. It is "essential that there is an alternative process — separate from whether a test is in any of the databases — to ensure coverage of evidence-based and guidelines-supported testing," Sarah Thibault-Sennett, senior director of reimbursement policy at the lab industry group ACLA, said via email. "If the LCDs are finalized as drafted, Medicare beneficiaries with cancer will lose coverage, and therefore access to clinically appropriate genetic testing, and their treatment teams will lose access to critically important tools for diagnosing and managing the Medicare beneficiaries' conditions." 

If a test is not included in one of the databases, laboratories will also lose out on reimbursement for that test, she noted. While the databases are "excellent resources for payors to utilize as they develop their own coverage policies," they shouldn't be used alone to determine coverage, she said.

In a letter to the MACs, ACLA further raised issue with the fact that the draft LCDs do not adhere to requirements under the Social Security Act stipulating that Medicare contractors summarize the evidence they used to make a coverage determination. The draft LCDs "include only an evaluation of the knowledgebases whose sponsors presumably have considered evidence regarding genetic testing," but the knowledgebases "are not designed with coverage determinations in mind, and they are not subject to notice-and-comment or public review by stakeholders," the organization wrote. 

Samuel Caughron, AMP's economic affairs committee chair, agreed that the databases included in the draft LCDs "were not designed to be validators of test technology for payment coverage policy." 

"Relying on these resources alone will create coverage gaps and will likely impact patient access to genetic testing of established clinical value," he said. "The policy must also recognize other evidence-based resources, including professional society guidelines" from AMP, the American Society of Clinical Oncology, the College of American Pathologists, and the World Health Organization, "as acceptable sources for coverage inclusion."

At Novitas' August public meeting, Brian Carey, a consultant to the Coalition for 21st Century Medicine, said many of the advocacy organization's member labs offer multianalyte algorithmic tests that may only be included in NCCN guidelines, but it can often be 18 months before such recommendations are updated with information about a new test. Novitas should offer flexibility, Carey said, and assess tests on a claim-by-claim basis, rather than automatically denying coverage for a test that isn't in NCCN guidelines at the time of review. 

ACLA also asked the MACs to do away with three documentation requirements listed in billing and coding articles associated with the LCDs: first, that every page of the record be legible and include appropriate patient identification information, as well as the legible signature of the healthcare provider providing care to the patient; and that the patient's treating clinician is also ordering the test.

The stipulation that for a test to be covered the clinician treating the patient must order it, "devalue(s) the critical role of the pathologist, run(s) counter to established workflows, and if finalized, will result in delaying care with the potential for substantial benefit to many patients," Caughron said.

Pathologists may need to order a molecular test to make a cancer diagnosis, for example, and requiring the treating clinician to order a genetic test "prevents the pathologist from completing the professional service and delays the diagnosis." 

At the public meeting, Novitas' Mann underscored the importance of "a knowledgeable provider" in ensuring proper use of "extremely complicated" genetic tests. "If the ordering provider is not directly involved in the management of a patient's cancer, their ordering of oncologic genetic testing is inappropriate," he added.

In a billing and coding article associated with the draft LCDs, stakeholders also flagged problems with the MACs' coding requirements. According to the article, many ICD-10 diagnosis codes for "unspecified" cancers or locations are not covered. Such codes, Caughron said, are often used to bill tests for patients with advanced disease, when the type or location of their cancer "defies specific coding." 

The lack of coverage for these codes "will create patient access barriers in these circumstances when patients need access to treatment the most." He further noted that more than 1,000 ICD-10 codes have been omitted from the draft billing and coding article.

There are other omissions from the draft LCDs that make the policies out of step with current genetic testing practices, he added. Neither LCD, for example, explicitly covers multi-gene panels or genomic sequencing procedures, Caughron noted. "The current standard of care in oncology includes the use of multi-gene panels to fully determine the biologic features of the cancer in patients with advanced disease," and that "is not recognized by appropriate corresponding coverage" by Novitas and FCSO. 

Test reimbursement consultant Bruce Quinn noticed other holes in the policies when it came to liquid biopsy and minimal residual disease testing, which are covered by Palmetto GBA and other MACs under the MolDx program. Caughron felt that Novitas and FCSO should cover liquid biopsy testing in cases where a high-quality tissue sample isn't available and it could be a complementary mode of testing. 

Beyond the actual coverage limitations, many detractors noted that the LCDs are confusingly written and hard to understand. Nikki Martin, senior director of precision medicine initiatives at the lung cancer nonprofit Lungevity Foundation, said the LCDs are written in a way that makes it hard to understand their full impact. The "dense and hard to read" language could also deter providers who aren't willing to spend the extra time deciphering coverage requirements from ordering a genetic test.

Moreover, third-party databases like ClinGen and OncoKB that MACs want to rely on to support coverage of genetic tests can provide evidence of a biomarker's role in cancer prognosis, diagnosis, or predicting treatment response, but these resources don't reference specific tests. This can make it hard to determine exactly which assays are covered and which aren't, Martin said. 

If the MACs decide not to cover a cancer genetic test based on the criteria in these draft LCDs, test sponsors can initiate a reconsideration process, but it can take up to 60 days to receive a response. Thibault-Sennett said this will add "unnecessary lead time" and is not a viable alternative. In its letter, ACLA urges Novitas and FCSO to remove the presumptive noncoverage limitation and include language supporting medically necessary reflex testing. 

ACLA recommends that both contractors design a transparent process for reviewing materials submitted for test coverage. That process "should involve a response to the submitting stakeholder, including the analysis of the MAC regarding the impact of the submitted material on a coverage consideration," Thibault-Sennett said. 

Addressing fraud concerns

The history of genetic testing billing fraud at Novitas and FCSO may be one reason why the MACs are tightening coverage criteria, some suspect. Quinn's analysis of data released last year by the US Centers for Medicare & Medicaid Services suggested labs were billing codes for rare disease and low-volume molecular pathology services at higher-than-expected rates in Novitas' and First Coast's regions. In 2021, total spending on these codes reached $595 million, with particularly high rates of that spending coming from states covered by Novitas and First Coast. That same year, both MACs released billing and coding articles saying that labs should rarely bill these codes, and when they do, they must identify the specific genes tested. 

Julie Eggington, the cofounder and CEO of the nonprofit Center for Genomic Interpretation, felt Novitas and FCSO are taking a "measured response" in releasing these new coverage criteria, "given how much money has been wasted and how much fraud has been committed through [the MACs]." 

The inclusion of the three knowledgebases in the LCDs is "a really great idea," she said, because they're very expansive, although she agreed that the databases weren't built for this purpose. Garnering support in one of these resources, however, shouldn't be hard if a laboratory is practicing evidence-based precision oncology, she added. Eggington said she couldn't imagine a test that should be given to a cancer patient if it didn't have support in NCCN guidelines, ClinGen, and OncoKB.

In contrast to other stakeholders, however, Eggington felt the MACs could be doing more to directly assess the quality of genetic tests. While the LCDs seem "very focused on trying to reduce the amount of fraud that's happening," the MACs aren't addressing the actual performance of these tests. "Even if your test meets all these requirements and it [includes] genes and biomarkers on one of these databases … it doesn’t mean that your test is actually going to work," she said. "You can check all the boxes off in this LCD and still have a test that gives you an inaccurate result."

CGI has been working with commercial payors, helping them directly assess the analytical and clinical validity claims that labs are making about their genetic tests. 

Eggington also took issue with ACLA's request to remove the requirements ensuring legibility of patient records and that the provider ordering the test is the patient's treating physician. The legibility requirement "seems reasonable," as there must be appropriate documentation that a patient needs this test, she said.

The requirement that the treating and ordering clinicians must be the same, however, could pose a problem for receiving high-quality care from multiple providers, she acknowledged. 

While stakeholders may disagree on the benefits and downsides of the LCDs, most agree that the proposed changes would broadly impact genetic test providers in the regions covered by Novitas and FCSO. The draft LCDs provide "sweeping and substantive change to coverage policy that has, in the case of some tests, been longstanding and widely accepted," AMP's Caughron said.