This spring, the Centers for Medicare and Medicaid Services (CMS) released its final National Coverage Determination (NCD) for next-generation sequencing (NGS) for Medicare beneficiaries with advanced cancer. Considering the unclear and potentially harmful language in the preliminary draft version, the final NCD policy should be considered a major success for clinical laboratory professionals, academic medical centers, leading cancer institutions, patient advocacy groups, and, most importantly, cancer patients across the country. While our collective efforts to share expertise and educate stakeholders ultimately helped convince CMS to make significant improvements to the policy, many important questions still remain unanswered. Clinical laboratory professionals are now intently focused on understanding how this policy will be operationalized and implemented.
I currently chair the Economic Affairs Committee (EAC) for the Association for Molecular Pathology (AMP). AMP is a global organization representing more than 2,400 physicians, doctoral scientists, and medical technologists who are among the early adopters of molecular testing in clinical settings. Our members are committed to ensuring broad patient access and coverage for the thousands of high-quality, clinically-proven NGS-based tests that are currently recognized as the standard of care in oncology diagnostics.
When the preliminary policy was released, the EAC and AMP members actively engaged congressional offices on both sides of the aisle to express concerns and share success stories of how NGS-based tests, including laboratory developed procedures (LDPs), are being used to benefit Medicare cancer patients every day. During the open comment period for the proposed coverage determination, AMP’s EAC submitted detailed recommendations with supporting evidence to refocus the scope of the final policy, highlighting significant inconsistencies with current coverage and coding structures for molecular pathology procedures utilizing NGS-based platforms.
We are encouraged that CMS considered our feedback and made important changes. Specifically, the final NCD aligns with AMP’s recommendations in two major ways:
First, AMP recommended that the final NCD should apply only to FDA-approved NGS-based in vitro diagnostics. The coverage was authored as part of the parallel review process and therefore appropriately addresses FDA-reviewed tests. However, as originally drafted, the policy went significantly further and excluded coverage for all other NGS-based testing for cancer patients. NGS-based LDPs provide clinically significant information for cancer patients and have already been designed and validated to meet or exceed Clinical Laboratories Improvement Amendment (CLIA) standards, and/or other federal, state, and professional accreditation organizations’ standards. The final NCD acknowledged these existing, time-tested LDP oversight entities and focused the national policy limitation primarily on FDA-reviewed NGS-based assays.
Second, AMP recommended that coverage for other appropriately validated NGS-based tests should continue to be determined by Local Coverage Determinations (LCDs) administered by Medicare Administrative Contractors (MACs). The broadly restrictive preliminary NCD would have superseded existing LCDs with established evidence-based coverage policies, thereby reducing patient access to these valuable tests. The policy would have disrupted the current high-quality patient care provided by many academic hospitals, leading cancer institutions, and community medical centers across the country.
Now that the final NCD has been released, the task of operationalizing its directives is underway. Within the coming months, CMS is expected to provide coding and implementation instructions to the MACs. These instructions will reveal CMS’s true intent. Hopefully, the final instructions will provide further positive developments in the form of patient-centered interpretive directives. In the meantime, laboratories are left with unanswered important questions. AMP is now working to obtain clarity on specific aspects of the NCD via direct communication with CMS, including:
- How will the new NCD align with the patient criteria outlined in both existing and new LCDs? For example, will MACs be able to provide coverage in LCDs that is broader than the NCD criteria, such as coverage in stage 2 patients?
- Is the specific terminology used to describe staging for advanced cancer in the final NCD meant to encompass all advanced malignancies? If so, how should the terminology be understood? Additionally, how should the NCD be interpreted for cancers that do not utilize traditional staging terminology?
- As science evolves and/or new indications are added to FDA labeling, how will the NCD be updated?
With the finalizing of the NCD, AMP believes the most significant issues with the policy were avoided. However, many questions about what the NCD means for individual laboratories remain. Because most molecular testing is provided at the local level, AMP members in those laboratories are sailing in the proverbial uncharted waters.
AMP is committed to working with policymakers to ensure appropriate implementation of the national policy that maintains access to NGS-based testing by laboratories across the country. Moving forward, members will continue to share our collective expertise, provide specific examples, and work with key stakeholders to further improve Medicare coverage and overall quality of patient care. We remain intently focused on preserving broad access to all of the accurate and reliable procedures, including the thousands of successful laboratory-developed testing procedures that benefit patients every day. Without precision diagnostics, there is no precision medicine.
