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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 DEXTM Diagnostics Exchange 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?

Michael F. Arrigo

Michael is Managing Partner & CEO of No World Borders, a leading healthcare management and IT consulting firm. He serves as an expert witness in Federal and State Court and was recently ruled as an expert by a 9th Circuit Federal Judge. He serves as a patent expert witness on intellectual property disputes, both as a Technical Expert and a Damages expert. His vision for the firm is to continue acquisition of skills and technology that support the intersection of clinical data and administrative health data where the eligibility for medically necessary care is determined. He leads a team that provides litigation consulting as well as advisory regarding medical coding, medical billing, medical bill review and HIPAA Privacy and Security best practices for healthcare clients, Meaningful Use of Electronic Health Records. He advises legal teams as an expert witness in HIPAA Privacy and Security, medical coding and billing and usual and customary cost of care, the Affordable Care Act and benefits enrollment, white collar crime, False Claims Act, Anti-Kickback, Stark Law, physician compensation, Insurance bad faith, payor-provider disputes, ERISA plan-third-party administrator disputes, third-party liability, and the Medicare Secondary Payer Act (MSPA) MMSEA Section 111 reporting. He uses these skills in disputes regarding the valuation of pharmaceuticals and drug costs and in the review and audit of pain management and opioid prescribers under state Standards and the Controlled Substances Act. He consults to venture capital and private equity firms on mHealth, Cloud Computing in Healthcare, and Software as a Service. He advises ERISA self-insured employers on cost of care and regulations. Arrigo was recently retained by the U.S. Department of Justice (DOJ) regarding a significant false claims act investigation. He has provided opinions on over $1 billion in health care claims and due diligence on over $8 billion in healthcare mergers and acquisitions. Education: UC Irvine - Economics and Computer Science, University of Southern California - Business, studies at Stanford Medical School - Biomedical Informatics, studies at Harvard Medical School - Bioethics. Trained in over 10 medical specialties in medical billing and coding. Trained by U.S. Patent and Trademark Office (USPTO) and PTAB Judges on patent statutes, rules and case law (as a non-attorney to better advise clients on Technical and Damages aspects of patent construction and claims). Mr. Arrigo has been interviewed quoted in the Wall Street Journal, New York Times, and National Public Radio, Fortune, KNX 1070 Radio, Kaiser Health News, NBC Television News, The Capitol Forum and other media outlets. See and for more about the company.

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