The Future of Test Specificity with Precision Genetic Test Management


Avalon Healthcare Solutions hosted a webinar on the current challenges, changes, and opportunities in genetic testing. Dr. Gabriel Bien-Willner discussed the Palmetto GBA MolDX program and its role in spurring innovation in genetic lab testing followed by Avalon Chief Medical Officer, Dr. Rahul Singal, who covered the incorporation of Z-Code specificity into Avalon’s Evidence-based Policy Development, Avalon’s Product Manager, Sarah Bretz, highlighted an innovative technology solution addressing the complex challenges with genetic test management, and  Julie Barnes, the principal of Maverick Health Policy, wrapped up the session with a policy and regulatory forecast.

Innovation in Genetic Testing: The Palmetto GBA MolDX Program
The MolDX program was originally created to overcome the challenge of ensuring proper adjudication of claims of rapidly evolving molecular tests for Medicare. Palmetto GBA originally pitched this program to Medicare in 2011 and over the last 12 years it has substantially evolved to be scalable, fair, and equitable to providers and payors alike. The procedures and controls embedded in the MolDX program were created in a difficult regulatory environment, which required automated solutions that demonstrate transparency and assurance to providers, increased access to care to beneficiaries, and decreased costs to payors.

Avalon Policy Development
Avalon’s robust policies contain a detailed scientific review that includes analytical validity, clinical validity, and clinical utility. The breadth of Avalon’s policies and the depth of scientific review creates the foundation for Avalon to uniquely manage laboratory tests at scale. Specific to genetic testing, the incorporation of the MolDX Z-Codes into Avalon’s policies aligns clinical and payment policy with genetic test evolution -– ensuring the right test is provided for the right care.

Challenges and Opportunities with Genetic Testing
There is an overwhelming number of genetic tests available today, with more than 10 new tests being developed every day. These are complex, expensive tests and the number of procedure codes available are limited. As the number of tests grow exponentially, lack of test management and oversight, combined with lack of specific test identification, make it challenging for payors to determine coverage eligibility, test validity and utility and to create opportunities for potential fraud, waste, and abuse. Existing solutions are not adequately addressing these challenges. According to the Department of Justice, in 2022 alone there was more than $1.2 billion in alleged fraudulent telemedicine, cardiovascular and cancer genetic testing and DME schemes across non-MolDX participating states. CPT codes simply lack the specificity needed to enforce coverage policy rules.

Precision Genetic Test Management (PGTM)
The MolDX program is expanding rapidly, and with 20,000 tests vetted so far, it is quickly emerging as the industry standard. Avalon in partnership with Optum is leveraging the emerging standard to uniquely identify discrete test quality and ensure consistent coding with automated policy enforcement through an NCQA-certified prior authorization program.

The Precision Genetic Test Management solution provides the following benefits to health plans:

  • Compliance with State Medicaid and Medicare Advantage coverage rules
  • Improved quality of patient care by ensuring genetic tests meet quality standards
  • Enhanced provider experience through prior-auth auto approval
  • FWA Prevention
  • Unique innovation that sets health plans apart

What’s the Latest from Washington D.C.?
On December 13, 2022, CMS released a 402-page proposed rule to automate prior authorization processes and there are multiple proposed rules on the horizon. Federal agencies are preparing to promulgate several final rules and are seeking industry guidance on the following proposals:

  • 01/31 – Privacy rule about substance use disorder records (42 CFR Part 2 data) and alignment with HIPAA
  • 02/03 – Individual health plan market rules (2024 Notice of Benefit and Payment Parameters)
  • 02/13 – Medicare Advantage and Part D market rules (CY2024 Changes to MA/Part D Program)
  • 03/13 – EPA Proposed Rule
  • 03/21 – CMS Attachments, eSignature, Prior Auth Standards

Due to the breadth of the Electronic Prior Auth (ePA) proposed rule and its impact on health plans, Avalon will host a special policy and regulatory session on February 15. In December, CMS released the proposed rule to speed up and align the prior authorization process across all payers. The deadline to submit comments to CMS is March 13. Register for the special webinar HERE.

Closing Remarks
Barry Davis, Avalon Chief Growth Officer, closed the webinar by discussing the unique challenge of low-volume, high-cost genetic tests, the importance of test specificity in this rapidly evolving field, and the result of the combined effort of Palmetto GBA, Avalon, and Optum to address these challenges in a novel way with Precision Genetic Test Management.

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Tuesday, September 17
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