Pacific Edge : C21 Comments on Novitas LCD DL39365

September 7, 2023

VIA Electronic Mail to:[e-mail]

Novitas Solutions

Medical Affairs

Suite 100

2020 Technology Parkway

Mechanicsburg, PA 17050

RE: Proposed LCD - Genetic Testing for Oncology (DL39365)

Dear Dr. Mann:

On behalf of the Coalition for 21st Century Medicine (C21), thank you for the opportunity to submit comments regarding the above-captioned proposed local coverage determination (LCD). C21 comprises many of the world's most innovative diagnostic technology companies, clinical laboratories, physicians, venture capital companies, and patient advocacy groups. C21's mission is to improve the quality of health care by encouraging research, development, and commercialization of innovative diagnostic technologies that will personalize patient care, improve patient outcomes, and substantially reduce health care costs.

For the reasons outlined below, C21 respectfully recommends that Novitas withdraw the draft LCD at the end of the comment period, and convene one or more Contractor Advisory Committee (CAC) meetings before engaging in future LCD development in genetic testing for oncology - both with respect to such tests in general, as well as the 13 specific tests evaluated in the proposed LCD. Engagement with the CAC would allow Novitas to obtain input from healthcare professionals, beneficiary representatives, and representatives of medical organizations to obtain meaningful feedback that would "ensure an unbiased and contemporary consideration of 'state of the art' technology and science" and would support the development of a clinically appropriate LCD.1 By considering the CAC's input (as well as that from interested stakeholders, like C21), Novitas could address key clinical questions and develop an updated proposal to ensure that Medicare beneficiaries will continue to have timely access to advanced molecular diagnostic tests.

Alternatively, if Novitas elects to finalize the LCD, C21 recommends that Novitas modify the LCD to remove the presumption against coverage for tests not supported in at least one of the three listed compendia, and convene a CAC meeting before finalizing non-coverage for the 13 specifically-referenced tests.

1 Medicare Program Integrity Manual ch. 13, § 13.2.4.3.

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1. SUPPORT FOR NOVITAS'S LONGSTANDING APPROACH TO COVERAGE OF DIAGNOSTIC TESTING SERVICES

For more than sixteen years, C21 has worked with the Centers for Medicare & Medicaid Services (CMS) and Medicare Administrative Contractors (MACs) on the development, promulgation, and implementation of policies intended to facilitate appropriate Medicare coverage and payment for high-quality clinical laboratory tests. C21 appreciates the work of Novitas over the past decade in reviewing novel advanced diagnostic tests and establishing LCD policies, including its current LCD for oncology tests, "Biomarkers for Oncology" (L35396). C21 strongly supports the current LCD, and appreciates Novitas's willingness to identify individual tests as covered services based on its assessment of the analytical validity, clinical validity, and clinical utility evidence supporting each test. As we noted in our Open Meeting presentation, we are concerned that the proposed "Genetic Testing for Oncology" LCD would, if finalized, significantly limit beneficiary access to advanced diagnostic tests, including many tests performed by C21 members with longstanding Medicare coverage following a previous test- specific evidence review by Novitas.

Historically, it has been both CMS' and Novitas' position that unless an LCD explicitly identifies a test as a non-covered service following an individualized review of the evidence for that test, such test would be eligible for Medicare coverage on a case-by-case basis. C21 strongly supports this position. Moreover, in recent years this requirement has been codified in federal law, as the 21st Century Cures Act prohibits Medicare contractors from implementing non-coverage policies unless the contractor makes an evidence-based determination that a test does not meet the statutory/regulatory criteria for Medicare coverage.2

2. CONCERNS WITH PROPOSED LCD FRAMEWORK

1. Novitas should not issue a final LCD that delegates coverage decisionmaking authority to external databases - particularly insofar as the the LCD does not contain a viable, timely alternative pathway to coverage.

Under the proposed LCD, a genetic test must have adequate support in one of three databases to be covered: (i) National Comprehensive Cancer Network's (NCCN) database, (ii) National Institutes of Health (NIH)-sponsored clinical genome resource, ClinGen, or (iii) Memorial Sloan Kettering's tumor mutation database, OncoKBTM. All tests not supported in one or more of these compendia would be presumptively non-covered, unless/until they successfully complete the LCD reconsideration process. This proposed coverage framework raises several concerns, including:

• While third-party guidelines/recommendations can provide useful information when deciding whether to cover a test, relying solely on such determinations is not a

2 Social Security Act § 1862(l)(5)(D).

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permissible substitute for evidence-based,test-specific review. Under the 21st Century Cures Act, MACs must include a "a summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence" (emphasis added) as well as "[a]n explanation of the rationale that supports such determination."3 Furthermore, while the Medicare Program Integrity Manual allows MACs to "supplement their research… with clinical guidelines, consensus documents, or consultation by experts," the Manual does not allow the MACs use these sources as a substitute for its own review.4 Therefore, the decision to cover or not cover a particular test must be based on evidence reviewed by Novitas, and Novitas must memorialize its rationale by publishing an explanation for the decision. Relying on a third-partydatabase without itself engaging in a test-specificevaluation or offering a test- specific rationale - as proposed - would be contrary to the Act, and amount to a preemptive non-coveragedetermination without the requisite test-specific,evidence- based review. Such reliance is particularly problematic insofar as there is no assurance that any of the compendia will have reviewed any individual test, particularly for novel assays.

• Novitas does not have authority to delegate coverage decisions to third parties. Congress delegated to the HHS Secretary the authority to "enter into contracts with any eligible entity to serve as a [MAC]" and establish LCDs.5 Congress did not, however, grant the Secretary or the MACs the authority to delegate powers to other private parties. The U.S. Court of Appeals for the District of Columbia Circuit has stated that that "subdelegations to outside parties are assumed to be improper absent an affirmative showing of congressional authorization."6
  The court's concern is particularly relevant here. When private entities (like NCCN or MSK) update their databases, or NIH updates ClinGen, they are not required to comply with any of the procedural controls that normally apply to the development of LCDs.
  Specifially, they are:

1. Not required to issue a proposed decision that explains their rationale; o Not required to accept public comments on those proposals;
   o Not required to hold an open meeting to collect stakeholder feedback; and
   o Not required to consider and respond to public comments when finalizing their decisions.

As a result, the decisions made by NCCN, MSK, and/or NIH are not subject to the same procedural controls and safeguards - and may be made with a different set of substantive considerations - than those that would have been required had the government's authorized delegate (Novitas) made the decision via the process required by law.

1. Id.
2. Medicare Program Integity Manual ch. 13, § 13.2.3.
3. 42 U.S.C. §§ 1395kk-1(a)(1), (a)(4).
4. U.S. Telecom Ass'n v. F.C.C., 359 F.3d 554, 565 (D.C. Cir. 2004).

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In support of its ability to delegate coverage decisions to third parties, Novitas points to Medicare's use of third-party compendia when deciding whether to cover certain chemotherapy drugs off-label.7 However, this precedent is distinguishable from the diagnostic testing in three key respects.

1. First, the Social Security Act explicitly requires Medicare to consider certain compendia when determining coverage for off-label uses for cancer chemotherapy drugs.8 There is no analogous instruction that allows Novitas to use the compendia in the same way for clinical laboratory tests.

1. Second, in the cancer drug context, the compendia are used to expandcoverage beyond FDA-approved labeling for certain drugs - not to restrict coverage.

• 1. And lastly, even if a particular off-label use is not supported in the compendia, Medicare explicitly retains the ability to review other published literature - i.e., Medicare is not solely bound based on the compendia's decision.9
• Availability of the LCD reconsideration process is not an adequate alternative pathway to coverage. Novitas states that interested stakeholders may request coverage for a test not supported in one of the three compendia via the LCD reconsideration process.
  However, this framework would not give test developers and other stakeholders an opportunity for public comment priorto implementation of non-coverage based on the compendia - even if the compendia themselves have not reviewed the evidence supporting a test. Therefore, reliance on the reconsideration process alone does not satisfy the requirement that MACs may not impose a policy restricting coverage for an item or service absent an evidentiary review. Rather, Novitas must review evidence, hold a public meeting, and consider public comment before making a non-coverage decision.
  Furthermore, Novitas makes no commitments regarding the timeframe on which it will substantively consider reconsideration requests, or how often it intends to update the LCD to reflect new evidence. MACs have 60 calendar days to determine whether a reconsideration request is valid.10 Once determined to be valid, however, CMS does not require the MACs to substantively respond to a reconsideration request within any specific period of time. As such, reconsideration requests may remain in a MAC's queue for several months, if not longer, depending on MAC workloads and priorities. Furthermore, even once a MAC decides to substantively respond to a reconsideration request issuing a proposed LCD, that MAC has up to 365 calendar days to issue a final LCD.11 As a result, tests not meeting compendia requirements may remain non-covered for multiple years, even if they otherwise have strong evidence supporting assay performance.

1. Article - Response to Comments: Genetic Testing for Oncology (A59417).
2. See Social Security Act § 1861(t)(2)(B) (applicable to Part B drugs); 1860D-2(e)(4) (applicable to Part D drugs); 1927(g)(1)(B) (applicable to drugs delivered to Medicaid beneficiaries).
3. See Medicare Benefit Policy Manual ch. 15, § 50.4.5(C).
4. See Medicare Program Integrity Manual ch. 13, §13.3.3.
5. Id. §13.5.1.

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• NCCN is the only pathway to coverage for multianalyte algorithmic tests to obtain coverage. Two of the three databases referenced by Novitas in the proposed LCD - ClinGen and OncoKB - do not review multianlayte algorithmic tests that may combine these variants with an empirically derived algorithm. These databases' restriction to single gene assays is plainly stated in their public-facingmaterials:

1. ClinGen: "We then use this data to answer a number of key curation questions: Is this gene associated with a disease, and by which mechanisms do variation cause this disease? Is this variant causative? Will this information affect medical management?"12 (emphasis added)

1. OncoKB: "Alteration- and tumor type-specific therapeutic implications are classified using the OncoKB™ Levels of Evidence system, which assigns clinical actionability to individual mutational events."13 (emphasis added)

(At the Open Meeting, a speaker from MSK/OncoKB explained that database does account for certain concurrent gene-gene interactions in its reporting. The speaker did not, however, refute the point that OncoKB does not include recommendations multianlyte algorithmic tests.) As a result, multianalyte tests would only be eligible for coverage if supported in NCCN.

Reliance on NCCN is not an appropriate substitute for evidence-based,test-specific review, as NCCN guidelines are largely consensus-based and may not reflect input from certain specialties or subsets of healthcare providers.14 Indeed, NCCN itself acknowledges the limitations of this approach:

The NCCN Guidelines® are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult the NCCN

Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes no representations or warranties of any kind regarding

1. https://clinicalgenome.org/start/.
2. https://www.oncokb.org/about.
3. NCCN, Development and Update of Guidelines,https://www.nccn.org/guidelines/guidelines-process/development-and-update-of-guidelines(last visited August 2023) ("Recommendations within the NCCN Guidelines are derived from critical evaluation of evidence, integrated with the clinical expertise and consensus of a multidisciplinary panel of cancer specialists, clinical experts and researchers in those situations where high-level evidence does not exist. Panels are charged with evaluating the efficacy of treatment, utility of tests or evaluations, and toxicity of the various interventions. Recommendations (or changes to existing recommendations) are agreed upon by Panel Members following review and discussion of the evidence during the Panel meetings. The Panel Members deliberate on the interpretation of the clinical evidence, and vote on how the evidence should be incorporated into the existing Guidelines. The Panel Chair and Panel Members then develop the wording to denote the specific recommendations within the Algorithms.")

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