Genetic Testing: Regulatory Considerations - PowerPoint Presentation

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Genetic Testing: Regulatory Considerations

Sharon Zehe, JDVice President, Business Affairs, Mayo Medical LaboratoriesLegal Counsel, Mayo Clinic

Genetic Testing: Medicare Regulations and Policy Considerations

Andrew B. Wachler, Esq.Wachler & Associates, P.C.210 E. 3rd Street, Suite 204Royal Oak, MI 48067awachler@wachler.com248-544-0888

G2 Intelligence Lab Institute 2017

Washington, D.C.

October 26, 2017

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Topics to Cover

PrivacyDiscriminationStandard of Care in Laboratory Testing

Variants of Unknown Significance

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Privacy

Is genetic sequence protected health information?Sequence versus interpretation of sequenceFingerprint versus sequenceDelicate balance between sharing sequencing data and related data, while protecting identity of participants / patientsEnvironmental Clinical HistoryFamily History Treatment plans

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Privacy in ResearchHow can data be used and shared before consent required?

Direct-to-Consumer labsReferral laboratoriesMany states have enacted “opt in” research provisions relating to genetic researchDefinition of “genetic research” variesNot all include use of biospecimens

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Informed Consent

Consent for research versus waived consentOHRP RequirementsCommon Rule proposal regarding biospecimen use

Did not implement informed consent for use of biospecimens

Bearder lawsuit in MinnesotaResulted in destruction of a million newborn blood spots used for researchState law now requires consent for storage

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Discrimination

Genetic Information Nondiscrimination ActBecame law in 2008Goal is to protect individuals from discrimination based on genetic informationHealth InsuranceEmployment

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Discrimination

EmploymentPre and post employment testing prohibitedProhibits discriminationProhibits discrimination in health insuranceDoes not cover life insurance, disability insurance, or long-term care insurancePatients worried about results for these purposes

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Variants of Unknown Significance

Williams v. Quest / Athena (South Carolina):In 2007, Athena reported variant of unknown significance on 2 year old patientChild had a missense mutation SCN1A, which at the time was not clearly linked to Dravet SyndromeMother claims Athena should have known a defect in SCN1A was not of unknown significanceSuspected, but not fully validatedCase could impact the standard of care for genetic testing

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Potential Impacts

How do providers balance negligence standards against regulatory validation requirements?Suspicion of connection?CLIA standard?FDA standard?What is provider’s obligation to provide updates when VUS becomes known?Based on what was known at the time?Or will future standard of care require a look back?

If so, how far back?

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Issues in Reimbursement Is the Genetic Test:

A Covered Service?Medically Necessary and Reasonable?Documented?Physician Order / RequisitionPhysician AttestationSupporting Medical RecordsCovered by an LCD?Indicated?Subject to the MolDX Program?Assigned a CPT Code(s)?Other Payer Requirements?

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Covered Service - Diagnostic TestsMedicare Part B will cover “medical and other health services” which includes “diagnostic services” and “diagnostic laboratory tests.” Social Security Act §§ 1832(a)(2)(B), 1861(s)(2)-(3).

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Covered Service - Diagnostic TestsExcluded from coverage are services that are

not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Social Security Act § 1862(a)(1)(A); 42 CFR § 411.15(k)(1).12

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Covered Service - Diagnostic Tests

42 CFR § 410.32(a) - All diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary.(b)(1) - Basic rule. Except as indicated in paragraph (b)(2) of this section, all diagnostic x-ray and other diagnostic tests covered under section 1861(s)(3) of the Act and payable under the physician fee schedule must be furnished under the appropriate level of supervision by a physician as defined in section 1861(r) of the Act. Services furnished without the required level of supervision are not reasonable and necessary (see §411.15(k)(1) of this chapter).

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Shared Burden to Provide Documentation?

The burden rests with the “provider, supplier, or beneficiary, as appropriate, [to] furnish to the [contractor] sufficient information to determine whether payment is due and the amount of payment.” 42 CFR § 424.5(a)(6); see also Social Security Act § 1833(e). Our initial request for information is made to the entity submitting the claim. That entity should submit whatever documentation it has in support of the claim. If the documentation provided by the entity submitting the claim does not demonstrate that the service is reasonable and necessary, we will take the following action: (1) Provide the ordering physician information sufficient to identify the claim being reviewed; (2) request from the ordering physician those part of a beneficiary’s medical record that are relevant to the specific claim(s) being reviewed; and (3) if the ordering physician does not supply the documentation requested, inform the entity submitting the claim(s) that the documentation has not been supplied and deny the claim. Source: Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic Laboratory Services, Final Rule, 66 Fed. Reg. 58788, 58800 (Nov. 23, 2001)

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Medical NecessityMedicare Program Integrity Manual – Chapter 13

Section 13.3 – Individual Claim Determinations When making individual claim determinations, the contractor shall determine whether the item or service in question is covered by based on an LCD or the clinical judgment of the medical reviewer. An item or service may be covered by a contractor if it meets all of the conditions listed § 13.5.1, Reasonable and Necessary Provisions in LCDsSection 13.5.1 – Reasonable and Necessary Provisions in LCDsAn item or service may be covered by a contractor LCD if: It is reasonable and necessary under 1862(a)(1)(A) of The Act. Only reasonable and necessary provisions are considered part of the LCD.

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Medical Necessity

Medicare Program Integrity Manual – Chapter 13Section 13.5.1 – Reasonable and Necessary Provisions in LCDsReasonable and NecessaryContractors shall describe in the draft LCD the circumstances under which the item or service is reasonable and necessary under 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:Safe and EffectiveNot experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary); andAppropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:

Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;Furnished in a setting appropriate to the patient's medical needs and condition;Ordered and furnished by qualified personnel;

One that meets, but does not exceed, the patient's medical need; andAt least as beneficial as an existing and available medically appropriate alternative.16

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Medical Necessity

Medicare Program Integrity Manual – Chapter 13Section 13.7.1 – Evidence Supporting LCDsContractor LCDs shall be based on the strongest evidence available. The extent and quality of supporting evidence is key to defending challenges to LCDs. The initial action in gathering evidence to support LCDs shall always be a search of published scientific literature for any available evidence pertaining to the item or service in question. In order of preference, LCDs should be based on:Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, andGeneral acceptance by the medical community (standard of practice), as supported by sound medical evidence based on:Scientific data or research studies published in peer-reviewed medical journals;

Consensus of expert medical opinion (i.e., recognized authorities in the field); orMedical opinion derived from consultations with medical associations or other health care experts;Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community. The broad range of available evidence must be considered and its quality shall be evaluated before a conclusion is reached.

LCDs which challenge the standard of practice in a community and specify that an item or service is never reasonable and necessary shall be based on sufficient evidence to convincingly refute evidence presented in support of coverage. Less stringent evidence is needed when allowing for individual consideration.17

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Palmetto GBA - MolDX

Molecular Diagnostic Services Program – MolDXThe purpose of the MolDX program is to identify tests, determine coverage, and determine reimbursement.MolDx recognizes that molecular diagnostic tests “present challenges because the Clinical Laboratory Fee Schedule pricing methodology does not account for the unique characteristics of these test.”To establish consistency in coverage and pricing decisions for molecular diagnostic tests, laboratories must bill with the correct CPT/HCPCS code and must also apply for and obtain a unique test identifier prior to billing for most molecular diagnostic tests.

Currently implemented in 6 Medicare jurisdictionsJE A/B MAC (California, Nevada, Hawaii and the US Pacific Territories of Guam, American Samoa and the Northern Marianas) administered by Noridian Healthcare SolutionsJF A/B MAC (Oregon, Washington, Idaho, Utah, Montana, Wyoming, Nevada, Arizona, North Dakota, South Dakota, Alaska, and the Aleutian Islands) administered by

Noridian Healthcare SolutionsJM A/B MAC (North Carolina, South Carolina, Virginia, and West Virginia) administered by Palmetto GBAJ5 A/B MAC (Iowa, Kansas, Missouri, and Nebraska) administered by WPS Government Health AdministratorsJ8 A/B MAC (Michigan and Indiana) administered by WPS Government Health AdministratorsJ15 A/B MAC (Ohio and Kentucky) administered by CGS Administrators, LLC18

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Local Coverage DeterminationsExample: Local Coverage Determination (LCD):

MolDX: BRCA1 and BRCA2 Genetic Testing (L36161)Original Effective Date: 4/15/2016Important Considerations:Coverage IndicationsLimitations on CoverageCoding InformationCPT/HCPCS CodesICD-9/ICD-10 Codes that Support Medical NecessityDocumentation Requirements

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Medicare Audit Contractors

Medicare Administrative Contractors (MACs) Zone Program Integrity Contractors (ZPICs) Uniform Program Integrity Contractors (UPICs)Recovery Audit Contractors (RACs)Medicare RACs & Medicaid RACsSupplemental Medical Review Contractor (SMRC)Office of Inspector General (OIG) audits

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Medicare Appeals Process

Rebuttal and Discussion PeriodRedeterminationAppeal deadline: 120 days (30 days to avoid recoupment) Reconsideration Appeal deadline: 180 days (60 days to avoid recoupment)Full and early presentation of evidence requirementAdministrative Law Judge HearingAppeal deadline: 60 daysCMS will recoup any alleged overpayment during this and following stages of appeal

Medicare Appeals Council (MAC)Appeal deadline: 60 daysFederal District CourtAppeal deadline: 60 days

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CMS Final Rule: New Regulations to Address Backlog

Major changes in the Final Rule include:Precedential authority to selected Medicare Appeals Council decisionsAttorney Adjudicators at OMHASubmission of Evidence for Medicare appeals

Appointed RepresentativesCMS Contractors participation in ALJ proceedings

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Settlement Conference Facilitation (SCF)

Designed to bring CMS and Appellant together to discuss the potential of a mutually agreeable resolution for claims appealed to the ALJIf a settlement cannot be reached, claims return to ALJ appeal levelSCF ExpansionPhase I (Implemented June 2014) – Limited Part B claim eligibilityPhase II (October 2015) – Expanded Part B claims eligibility requirementsPhase III (February 2016) – Part A claims eligible

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Statistical Sampling Initiative

Provides appellants an additional avenue to handle large volumes of claims appealed to the ALJ appeal level.Statistical sampling draws a random sample from a universe of claims and extrapolates (projects) the results of the sample to the entire universe of claims OMHA statistical sampling is conducted using a trained and experienced statistical expert to develop the appropriate sampling methodology in accordance with Medicare guidance (CMS, Medicare Program Integrity Manual (Pub. 100-08), ch. 8) and randomly select the sample units ALJ then review the sample units and make findings and a decision on those sample units

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QUESTIONS?

Sharon

Zehe

, JDVice President, Business Affairs, Mayo Medical LaboratoriesLegal Counsel, Mayo Clinic25

Andrew B. Wachler, Esq.

awachler@wachler.com

248-544-0888