Today we're releasing a new white paper that surveys the landscape of Medicare policy for Minimal Residual Disease testing (MRD testing).
This important new class of oncology diagnostics is having major impacts on the management of cancer patients. Medicare policy for coverage is based primarily on a master foundational LCD used in the MolDx states - about 29 states. (The other states, under the NGS MAC and Novitas/First Coast systems, have no policies yet for MRD testing).
But local coverage for MRD, which usually matched to up-to-date cancer guidelines, sometimes collides with a 2018 national coverage decision (NCD) on all cancer testing involving next-generation sequencing. That 2018 document was based on the then-new coverage for the Foundation Medicine tumor panel test, and targeted coverage to advanced cancers, with one test per patient. Those principles are now obviously outdated, since MRD testing can be a valuable test for completeness of resection, even in stage 2 cancers, and may be used as serial tests for therapy management or for relapse detection.
We lay out the history, policies, and potential policy improvements in a new white paper.
- Find the PDF here.
AI Corner
While the 25-page white paper is "manually" written - and this is about the tenth draft! - I don't think I can do a better job of summarizing it than Chat GPT 4 can. Here's an AI summary of the white paper:
Summary of the White Paper:
Minimal Residual Disease Testing: A Case Study for Policy Reforms
Introduction and Key Findings The white paper delves into Minimal Residual Disease (MRD) testing, emphasizing its critical role in detecting cancer recurrence, monitoring therapy response, and assessing the completeness of cancer resection. It highlights the transformative potential of MRD tests, particularly those based on circulating tumor DNA (ctDNA), over traditional imaging methods like CT and MRI. The paper reviews current MRD technologies, their applications, and the need for policy reforms to support their broader adoption.
Technologies for MRD MRD tests have evolved significantly, with key players like Adaptive Biotechnologies' ClonoSEQ, Natera's Signatera, and Guardant Health's Reveal leading the field. These tests use various technologies, from bespoke sequencing approaches to standardized tests for specific cancers. The paper discusses the diverse applications of MRD, including:
- Detecting cancer recurrence earlier than imaging.
- Monitoring therapy response.
- Assessing the completeness of cancer resection.
Insurance Coverage and Policy Issues Insurance coverage for MRD testing varies widely. The paper outlines the discrepancies in Medicare coverage across different regions, highlighting the advanced policies of the MolDx program and the lack of systematic policies in other Medicare regions. Key policy issues include:
- The restrictive national coverage decision (NCD) for NGS-based testing, which limits serial testing and coverage for early-stage cancers.
- The 14-day rule for inpatient services, causing delays in test availability post-surgery.
- The complex and fragmented coding system, with a proliferation of PLA codes that are not widely accepted.
- Slow and non-transparent pricing processes for new tests.
Stakeholder Analysis The white paper examines the perspectives of various stakeholders:
- Payers: MRD can reduce costs and improve patient outcomes by enabling more precise treatment decisions.
- Diagnostic labs: Leading labs like Natera emphasize the importance of reimbursement dynamics and intellectual property positioning.
- Biopharma: MRD tests offer new surrogate markers for clinical trials, particularly in adjuvant and neoadjuvant therapy.
- FDA: The regulatory landscape is evolving, with new guidelines and approvals for MRD tests expected to impact the market.
Regulatory and Legislative Uncertainties Two significant areas of uncertainty are highlighted:
- The impact of new FDA regulations bringing lab-developed tests under FDA control by 2027.
- The influence of state biomarker coverage laws, which mandate coverage for biomarker tests by commercial insurers in some states.
Future Directions and Recommendations The white paper concludes with several recommendations to improve MRD testing policies:
- Reopen NCD 90.2 to enhance coverage for early-stage cancers and serial testing.
- Revise the 14-day rule to allow immediate testing post-discharge.
- Develop general CPT codes for major types of MRD testing.
- Increase transparency in coverage decisions, particularly within the MolDx program.
