Laboratory stakeholders urge CMS to revise its policy decision on NGS

Interview by Steve Halasey

At the end of January, a group 63 healthcare organizations came together to voice their concern over the way that the Centers for Medicare and Medicaid Services (CMS) is implementing its 2018 national coverage determination (NCD) on the use of next-generation sequencing (NGS) tests for patients with cancer. In a letter to CMS Administrator Seema Verma, MPH, the organizations expressed their concern that the agency’s new interpretation of its policy “will restrict patients’ access to medically necessary and relevant testing of germline mutations in cancer patients, and will adversely impact cancer patients’ care and outcomes.”1

In their letter, the organizations urged CMS to revise its current interpretation of the NCD by limiting it to somatic tumor testing, and to communicate this change to its Medicare administrative contractors (MACs).

“It is essential that CMS unequivocally maintain coverage for medically necessary NGS-based tests,” says Julie Khani, president of the American Clinical Laboratory Association.“Imposing broad restrictions on standard-of-care testing will have serious consequences for Medicare beneficiaries and negatively impact their care.”

To find out more about how CMS’s implementation of its NCD will affect clinical laboratories and their patients, CLP recently spoke to Victoria M. Pratt, PhD, associate professor of clinical medicine and molecular genetics at Indiana University, and current president of the Association for Molecular Pathology.

CLP: In March 2018, CMS issued a national coverage determination favoring the use of NGS for patients with advanced cancer. What evidence did the agency use in making its determination?

Victoria M. Pratt, PhD: CMS offered a detailed summary of the evidence considered during its review in Section VII of the March 2018 decision memo.2 The evidence used was primarily 30 articles about clinical trials published in peer-reviewed medical journals, which had been cited by the requestor, as well as those found by a CMS literature review. However, those 30 publications focused on somatic tumor testing, not inherited mutations.

NGS-based testing is now the standard of care for cancer patients. But CMS’s current interpretation implies that NGS-based testing for both germline and somatic tumors will be non-covered for patients with early-stage cancer. This decision has a direct impact on beneficiaries’ access to and coverage for essential testing that can make a fundamental difference in their treatment. In particular, those with early-stage cancer who may have a genetic predisposition based on family history or other criteria will not be eligible for testing using NGS-based methods. Restricting patients with early-stage cancers from accessing hereditary testing may lead to poorer outcomes, as they may not receive optimal therapy based on their genetic status.

CLP: How did this national coverage determination evolve over time to account for the latest advances in NGS technology?

Pratt: CMS initiated its national coverage analysis to thoroughly review the evidence and determine whether a diagnostic laboratory test using NGS for cancer patients may be covered nationally under the Medicare program. The initial request for the analysis and determination was for the F1CDx test, Foundation Medicine’s NGS comprehensive genomic profiling test for solid metastatic tumors, including stage IV and recurrent cancers.3 The test was reviewed and considered as part of the FDA/CMS parallel review pathway and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies.

CMS posted its proposed decision memorandum in November 2017.4 During the following open comment period, numerous stakeholders submitted more than 300 comments that expressed concern about both the overly restrictive and vaguely written non-coverage section of the policy and its potential application to germline testing. The comments offered detailed recommendations to CMS with supporting evidence to refocus the scope of the final policy, and also highlighted significant inconsistencies with current coverage and coding structures for molecular pathology procedures utilizing NGS-based platforms.

After considering the comments and additional evidence, CMS revised and finalized its decision in March 2018.2 The finalized NCD removed the non-coverage section and seemed to restrict the scope of the determination to somatic tumor testing only. The finalized NCD also added a new section that permits Medicare administrative contractors (MACs) to determine coverage of other NGS-based tests for advanced cancer. Thus, local coverage determinations (LCDs) for NGS-based tests for cancer and other conditions could continue to be promulgated at the local level.

At the time, AMP and other stakeholders considered the final NCD to be a vast improvement over the earlier draft. AMP members actively worked with many patient advocacy groups, academic medical centers, leading cancer institutions, and clinical laboratory professionals to share our collective expertise, educate stakeholders, and convince CMS to make significant improvements.

CLP: What has happened to take the course of CMS’s finalized NCD off track?

Pratt: Since the release of the final NCD, AMP has been closely following the implementation of this policy. Unfortunately, CMS is now communicating instructions that do not align with what was outlined in the finalized NCD. The contractor transmittal released in January includes some of the non-coverage language that had appeared in the initial draft policy, but was later discarded and not included in the final version.

In spite of the fact that the initial determination was requested for a somatic-based test, it is our understanding that CMS has been instructing MACs to apply the terms of the NCD to germline NGS testing as well. Such an interpretation implies that both germline and somatic tumor NGS-based testing will be non-covered for patients with early-stage cancer.

CLP: Is there an evidence base to support CMS’s broad interpretation of the national coverage decision on the use of NGS?

Pratt: No. The focus of the evidence review within the NCD memo is on publications about somatic tumor testing, not inherited mutations. To make matters worse, there was never a formal opportunity to submit comments or discuss the implementation of this policy.

CLP: Why was there no public comment period for this policy change? Doesn’t the requirement for notice-and-comment rulemaking apply here?

Pratt: This is a question that AMP and the 62 other cosigning organizations seek to understand. We are extremely frustrated that CMS’s interpretation contradicts and reverses previously established policies. The NCD supersedes existing local coverage determinations that provide crucial coverage of NGS-based genetic testing for mutations associated with inherited cancer syndromes—such as hereditary breast and ovarian cancer and Lynch syndrome—in patients without advanced cancer.

CLP: How does CMS’s interpretation of the NGS NCD relate to previously existing local coverage determinations favoring broader use of NGS?

Pratt: AMP believes that CMS’s overly broad interpretation is a significant policy overreach that directly contradicts previously established policies and negatively affects the quality of care for early-stage cancer patients. The NCD supersedes existing LCDs that provide crucial coverage of NGS-based genetic testing for mutations associated with inherited cancer syndromes—such as hereditary breast and ovarian cancer and Lynch syndrome—in patients without advanced cancer.

For example, there are existing LCDs allowing testing for early-stage cancer patients to receive germline testing for BRCA1 and BRCA2. However, as a result of the contractor transmittal, Palmetto, Noridian, CGS, and WPS have revised their local coverage determinations to indicate they will no longer cover NGS-based tests to determine whether women with stage 1 or stage 2 cancer have an inherited predisposition for breast and ovarian cancer.

During the open comment period after the draft decision memo was released, numerous organizations submitted comments that expressed serious concerns and advocated that:

  • The non-coverage section of the proposed NCD be removed.
  • MACs retain the authority to maintain their existing LCDs for NGS-based germline tests for early-stage cancer patients, such as BRCA1 and BRCA2 genetic testing for patients suspected of hereditary breast or ovarian cancer syndromes.
  • MACs retain the ability to implement new policies in their jurisdiction for germline and other NGS-based testing that is not related to advanced cancers.

While we were pleased that CMS revised the national coverage analysis to allow MACs to retain the ability to develop LCDs for certain NGS-based tests, we are now very alarmed that CMS is communicating instructions that do not align with what was outlined in the finalized NCD.

CLP: What is the likely effect of this seeming shift in policy?

Pratt: We are very concerned that CMS’s recent interpretation of the NCD will restrict patient access to medically necessary and relevant testing for germline mutations, and adversely affect cancer patient care and outcomes. CMS should not be creating additional barriers to Medicare beneficiaries’ access to clinically appropriate NGS-based testing.

AMP believes that CMS’s overly broad interpretation is a significant policy overreach that directly contradicts previously established policies and negatively impacts the quality of care for early-stage cancer patients.

CLP: What are the potential harms to patients if CMS’s interpretation of the NGS NCD is allowed to stand?  

Pratt: CMS’s overly broad interpretation of its NCD restricts the access of Medicare beneficiaries to vital testing and adversely affects cancer care. As a result of this overly broad interpretation, Medicare patients with early-stage cancer will receive suboptimal care.

In particular, patients with early-stage cancer who may have a genetic predisposition based on family history or other criteria will not be eligible for testing using NGS-based methods, which is now the standard of care for cancer patients. Such patients will not able to learn more about their risk of subsequent cancer nor be able to inform at-risk family members.

In addition, germline NGS testing increasingly has indications for cancer therapeutics, as when a patient’s mutational status suggests the use of poly (ADP-ribose) polymerase (PARP) inhibitors. Restricting patients from accessing hereditary testing means that they will not receive optimal therapy based on their genetic status.

CLP: Can CMS resolve this issue as quickly as it was created, by changing its interpretation of the NGS NCD?

Pratt: Yes, CMS can revise its interpretation and its contractor transmittal of the NCD quickly, so that the interpretation appropriately aligns with the language and evidence provided in the finalized decision memo.

CLP: What correctives are stakeholders suggesting to get CMS’s policy back on track? What do you hope CMS will do to resolve this issue?

Pratt: AMP and the 62 other leading cosigned healthcare organizations strongly urge CMS to limit its current interpretation of the NCD to somatic tumor testing, and to communicate this change to the MACs as soon as possible. We hope CMS will consider the collective comments from this diverse community of healthcare organizations and reinstate coverage for medically necessary hereditary cancer tests.

AMP will continue to work with CMS, local MACs, and other stakeholders to preserve broad patient access to the thousands of clinically and analytically validated NGS-based test procedures for cancer and other conditions that benefit patients each and every day. Without precision diagnostics, there can be no precision medicine.

References

  1. Letter from 63 Healthcare Organizations to Seema Verma, Administrator, Centers for Medicare and Medicaid Services [online]. Washington, DC: Association for Molecular Pathology, 2019. Available at: www.amp.org/amp/assets/file/advocacy/group_stakeholder_letter_ngsncd-final-1-31-2019.pdf. Accessed February 7, 2019.
  1. Decision Memo for Next-Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) [online]. Baltimore, Md: Centers for Medicare and Medicaid Services, 2018. Available at: www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?ncaid=290#top. Accessed February 7, 2019.
  1. Formal Request for an NCD: Comprehensive Genomic Profile Testing with Foundation One CDx [online]. Cambridge, Mass: Foundation Medicine, 2017. Available at: www.cms.gov/medicare/coverage/determinationprocess/downloads/id290.pdf. Accessed February 7, 2019.
  1. Proposed Decision Memo for Next-Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) [online]. Baltimore, Md: Centers for Medicare and Medicaid Services, 2017. Available at: www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?ncaid=290&bc=aaaaaaaaacaa&. Accessed February 7, 2019.

Steve Halasey is chief editor of CLP.