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Discordance Between Medicare Administrative Contractors’ Policies Threatens
Uniform Access to Quality Care for Medicare Recipients with Lung Cancer

National Government Services, Inc. (NGS), the Medicare Administrative Contractor, or MAC, that covers certain geographies of the United States, including Massachusetts, issued a draft local coverage determination (LCD) on Thursday for the use of genomic sequencing panels to identify select driver mutations in patients with non-small cell lung cancer (NSCLC). Foundation Medicine has strong concerns with the draft policy and believes the policy, as written, threatens to undermine uniform access to high quality care for Medicare patients with Stage IIIb/IV NSCLC.

Specifically, our concerns for patient care center around three main areas:

1. Lack of quality standards in the LCD may threaten patient safety: In sharp contrast to the LCD issued in July by Palmetto GBA, a thought leading MAC in the area of molecular diagnostics, NGS’ draft policy makes no reference to minimum standards for test design and performance using a next generation sequencing platform, nor does the LCD attempt to define important criteria that establish high benchmarks for quality, accuracy and reliability of test results. Without a clear definition of which profiling tests qualify for coverage and without mandating published analytic and clinical validation of these complex genomic tests across all classes of genomic alteration, low-quality testing panels are likely find their way into cancer care. This trend will undermine patient safety, informed therapeutic treatment options, and clinical outcomes.

Further, this lack of validation will harm patients, as FMI has demonstrated in multiple peer-review publications. For example, there is an approximate 15-20% false negative rate for EGFR and ALK results alone among the multiple commercially available tests that the draft LCD proposes to cover. Missing these alterations would likely result in some patients not receiving highly effective targeted therapies for their lung cancer and instead these patients will receive only cytotoxic chemotherapy, a less effective approach, for their disease.

Highlighting this deficiency in the proposed LCD, NGS’ draft is in sharp contrast to both Palmetto GBA’s LCD, as well as a medical policy published by United Healthcare, one of the nation’s largest private payers. Both of those policies, in acknowledgement of abundant data regarding the variable quality of genomic testing, require high but achievable standards for analytic and clinical validation for covered tests. This necessary validation ensures that physicians will receive accurate and reliable test results on which to base very important prescribing decisions.

Several MACs (Noridian and CGS) across the country have moved swiftly to adopt Palmetto’s final coverage determination. They have done so because of the policy’s clear definition of what tests qualify, as well as the policy’s requirements for validation standards. Importantly, Palmetto’s LCD also makes the fundamental distinction between a comprehensive approach to genomic sequencing versus a limited gene panel test that fails to analyze the entire coding regions of cancer genes, thereby threatening to miss important targeted therapy options for patients. NGS’ draft policy LCD ignores this critically important and medically necessary comprehensive approach for Medicare patients.

2. Omissions compared with the National Comprehensive Cancer Network (NCCN) guidelines will limit patient access to FDA-approved treatments: NGS’ draft policy makes reference to a subset of NCCN guidelines for testing specific gene analytes in first line and refractory lung cancer. While the LCD claims to mirror the standard medical guidelines for high quality care, the policy overlooks testing for RET and HER2 contained in the NCCN Guidelines. Published literature clearly points to the fact that RET and HER2 are important markers in advanced, refractory lung cancer, and comprehensive testing for these analytes in both first line and metastatic lung cancer can lead to potential therapeutic treatment options for patients.

3. Disregard for national guidelines will limit access to promising emerging therapies: NGS’ draft policy is silent on NCCN’s guidelines that recommend broad molecular profiling to allow the identification of less common or rare driver mutations in lung cancer, which are results that often enable access to potentially beneficial clinical trials. Clinical trials have become a critical component of cancer care and are necessary to ensure access to targeted therapies for Medicare patients. Broad molecular profiling across all four classes of genomic alterations is required to comprehensively identify all clinically relevant treatment options, including the more than 3,000 targeted therapy trials enrolling patients today. By limiting coverage to undefined genomic sequencing panels of 5-50 genes without validation standards, many Medicare patients could be put in harm’s way, either by missing appropriate testing to identify therapeutic options, or by missing treatment based on erroneous understanding of the full breadth of clinically relevant genomic alterations in lung cancer. As drafted, NGS’ policy eliminates access to the full scope of FDA-approved treatment and clinical trial options for Medicare beneficiaries nationwide.

Beyond the limitations of uniform quality and access in this draft LCD, Foundation Medicine finds it particularly worrisome that there can exist such enormous discrepancies in policy decisions and processes among our nation’s MACs. While we acknowledge NGS’ policy is a draft, and it does extend testing to a broader set of lung cancer patients without discrimination by smoking status, much work is necessary to ensure a final policy is adopted that ensures all Medicare patients with late stage NSCLC receive safe and efficacious care.

Other MACs, as well as regional and national commercial payers, have invested years with Foundation Medicine learning about our approach, reviewing relevant data and understanding the benefits and limitations of comprehensive genomic profiling, all in an effort to make well-informed coverage decisions for their policy holders. NGS has not dedicated the same attention and effort. We believe strongly that collaboration with leading Medicare providers is essential to constructing truly informed coverage decisions about the benefits, risks and limitations of innovative technologies. Anything less is unacceptable for Medicare patients.

Foundation Medicine urges NGS to reconsider its draft policy. NGS could deliver a policy that provides the right approach medically, while ensuring important validation standards are achieved. NGS has the opportunity to broaden uniform patient access, adhere to national guidelines, prioritize patient safety and deliver a much-needed path for all Medicare patients to share in the promise of precision medicine.