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Genetic Test Medicare LCD development Standards

Genetic Test Medicare LCD

Medicare Local Coverage Determinations for Genetic Testing

Medicare Technical Assessment for Molecular Assays

To determine coverage for genetic test Medicare LCD, the Centers for Medicare and Medicaid (CMS) requires a Technical Assessment (TA) for molecular assays that are laboratory developed tests (LDT).  LDTs :

  1. utilize Next Generation Sequencing (NGS) technology,
  2. utilize new or novel technology, or
  3. have undefined or unproven clinical utility

During the TA period, test developers are requested by CMS to suspend submission of claims for the test. Before submitting a TA, a Medicare Administrative Contractor (MAC) such as Palmetto GBA may require that a lab register a test and obtain a unique identifier through the DEX Registry.

Medicare LCD development

The MAC may require that the assay must have :

  1. clinical utility (CU),
  2. fulfill the CMS “reasonable and necessary” criteria, and
  3. meet analytical and clinical validity (AV/CV) standards.

In addition to the ACCE criteria developed by the Centers for Disease Control and Prevention.

Medicare Requires use of ACCE Criteria for Genetic Test Coverage

CMS requests that Medicare LCDs for genetic tests be developed using “ACCE” which stands for:

  • analytic validity,
  • clinical validity,
  • clinical utility,
  • ethical, legal, and social implications

ACCE uses four categories for determining Medicare local coverage determinations (LCDs) for a genetic test. The ACCE methodology includes

  1. data collection,
  2. evaluation,
  3. interpretation, and
  4. reporting

regarding DNA and associated testing for disorders with a genetic component.  The methodology enables policymakers to access up-to-date and bioinformatic data for decision-making.

There are forty-four (44) questions:

The ACCE criteria are below:

ACCE Genomics 44 Targeted Questions

Elements (analytic validity, clinical validity, clinical utility ethical, legal and social implications)ComponentACCE Model Process Specific Question for Evaluating a Genetic Test (CMS has directed MolDX to follow the ACCE criteria developed by the Centers for Disease Control and Prevention in developing Medicare LCDs that define conditions of coverage for genetic tests)
Disorder/SettingN/A1. What is the specific clinical disorder to be studied?
Disorder/SettingN/A2. What are the clinical findings defining this disorder?
Disorder/SettingN/A3. What is the clinical setting in which the test is to be performed?
Disorder/SettingN/A4. What DNA test(s) are associated with this disorder?
Disorder/SettingN/A5. Are preliminary screening questions employed?
Disorder/SettingN/A6. Is it a stand-alone test or is it one of a series of tests?
Disorder/SettingN/A7. If it is part of a series of screening tests, are all tests performed in all instances (parallel) or are only some tests performed on the basis of other results (series)?
Analytic ValidityN/A8. Is the test qualitative or quantitative?
Analytic ValiditySensitivity9. How often is the test positive when a mutation is present?
Analytic ValiditySpecificity10. How often is the test negative when a mutation is not present?
Analytic ValiditySpecificity11. Is an internal QC program defined and externally monitored?
Analytic ValiditySpecificity12. Have repeated measurements been made on specimens?
Analytic ValiditySpecificity13. What is the within- and between-laboratory precision?
Analytic ValiditySpecificity14. If appropriate, how is confirmatory testing performed to resolve false positive results in a timely manner?
Analytic ValiditySpecificity15. What range of patient specimens have been tested?
Clinical ValiditySensitivity16. How often does the test fail to give a useable result?
Clinical ValiditySpecificity17. How similar are results obtained in multiple laboratories using the same, or different technology?
Clinical ValiditySpecificity20. Are there methods to resolve clinical false positive results in a timely manner?
Clinical ValidityPrevalence21. What is the prevalence of the disorder in this setting?
Clinical ValidityPrevalence22. Has the test been adequately validated on all populations to which it may be offered?
Clinical ValidityPrevalence23. What are the positive and negative predictive values?
Clinical ValidityPrevalence24. What are the genotype/phenotype relationships?
Clinical ValidityPrevalence25. What are the genetic, environmental or other modifiers?
Clinical UtilityIntervention26. What is the natural history of the disorder?
Clinical UtilityIntervention27. What is the impact of a positive (or negative) test on patient care?
Clinical UtilityIntervention28. If applicable, are diagnostic tests available?
Clinical UtilityIntervention29. Is there an effective remedy, acceptable action, or other measurable benefit?
Clinical UtilityIntervention30. Is there general access to that remedy or action?
Clinical UtilityIntervention31. Is the test being offered to a socially vulnerable population?
Clinical UtilityQuality Assurance32. What quality assurance measures are in place?
Clinical UtilityPilot Trials33. What are the results of pilot trials?
Clinical UtilityHealth Risks34. What health risks can be identified for follow-up testing and/or intervention?
Clinical UtilityHealth Risks35. What are the financial costs associated with testing?
Clinical UtilityEconomic36. What are the economic benefits associated with actions resulting from testing?
Clinical UtilityFacilities37. What facilities/personnel are available or easily put in place?
Clinical UtilityEducation38. What educational materials have been developed and validated and which of these are available?
Clinical UtilityEducation39. Are there informed consent requirements?
Clinical UtilityMonitoring40. What methods exist for long term monitoring?
Clinical UtilityMonitoring41. What guidelines have been developed for evaluating program performance?
ELSI (ethics, legal, and social issues)Impediments42. What is known about stigmatization, discrimination, privacy/confidentiality and personal/family social issues?
ELSI (ethics, legal, and social issues)Impediments43. Are there legal issues regarding consent, ownership of data and/or samples, patents, licensing, proprietary testing, obligation to disclose, or reporting requirements?
ELSI (ethics, legal, and social issues)Safeguards44. What safeguards have been described and are these safeguards in place and effective?
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Michael F. Arrigo

Michael Arrigo, an expert witness, and healthcare executive, brings four decades of experience in the software, financial services, and healthcare industries. In 2000, Mr. Arrigo founded No World Borders, a healthcare data, regulations, and economics firm with clients in the pharmaceutical, medical device, hospital, surgical center, physician group, diagnostic imaging, genetic testing, health I.T., and health insurance markets. His expertise spans the federal health programs Medicare and Medicaid and private insurance. He advises Medicare Advantage Organizations that provide health insurance under Part C of the Medicare Act. Mr. Arrigo serves as an expert witness regarding medical coding and billing, fraud damages, and electronic health record software for the U.S. Department of Justice. He has valued well over $1 billion in medical billings in personal injury liens, malpractice, and insurance fraud cases. The U.S. Court of Appeals considered Mr. Arrigo's opinion regarding loss amounts, vacating, and remanding sentencing in a fraud case. Mr. Arrigo provides expertise in the Medicare Secondary Payer Act, Medicare LCDs, anti-trust litigation, medical intellectual property and trade secrets, HIPAA privacy, health care electronic claim data Standards, physician compensation, Anti-Kickback Statute, Stark law, the Affordable Care Act, False Claims Act, and the ARRA HITECH Act. Arrigo advises investors on merger and acquisition (M&A) diligence in the healthcare industry on transactions cumulatively valued at over $1 billion. Mr. Arrigo spent over ten years in Silicon Valley software firms in roles from Product Manager to CEO. He was product manager for a leading-edge database technology joint venture that became commercialized as Microsoft SQL Server, Vice President of Marketing for a software company when it grew from under $2 million in revenue to a $50 million acquisition by a company now merged into Cincom Systems, hired by private equity investors to serve as Vice President of Marketing for a secure email software company until its acquisition and multi $million investor exit by a company now merged into Axway Software S.A. (Euronext: AXW.PA), and CEO of one of the first cloud-based billing software companies, licensing its technology to Citrix Systems (NASDAQ: CTXS). Later, before entering the healthcare industry, he joined Fortune 500 company Fidelity National Financial (NYSE: FNF) as a Vice President, overseeing eCommerce solutions for the mortgage banking industry. While serving as a Vice President at Fortune 500 company First American Financial (NYSE: FAF), he oversaw eCommerce and regulatory compliance technology initiatives for the top ten mortgage banks and led the Sarbanes Oxley Act Section 302 internal controls I.T. audit for the company, supporting Section 404 of the Sarbanes Oxley Act. Mr. Arrigo earned his Bachelor of Science in Business Administration from the University of Southern California. Before that, he studied computer science, statistics, and economics at the University of California, Irvine. His post-graduate studies include biomedical ethics at Harvard Medical School, biomedical informatics at Stanford Medical School, blockchain and crypto-economics at the Massachusetts Institute of Technology, and training as a Certified Professional Medical Auditor (CPMA). Mr. Arrigo is qualified to serve as a director due to his experience in healthcare data, regulations, and economics, his leadership roles in software and financial services public companies, and his healthcare M&A diligence and public company regulatory experience. Mr. Arrigo is quoted in The Wall Street Journal, Fortune Magazine, Kaiser Health News, Consumer Affairs, National Public Radio (NPR), NBC News Houston, USA Today / Milwaukee Journal Sentinel, Medical Economics, Capitol ForumThe Daily Beast, the Lund Report, Inside Higher Ed, New England Psychologist, and other press and media outlets. He authored a peer-reviewed article regarding clinical documentation quality to support accurate medical coding, billing, and good patient care, published by Healthcare Financial Management Association (HFMA) and published in Healthcare I.T. News. Mr. Arrigo serves as a member of the board of directors of a publicly traded company in the healthcare and data analytics industry, where his duties include: member, audit committee; chair, compensation committee; member, special committee.

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