IE 4: Week 13 Ethical Legal Reimbursement

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27 Terms

1

What are the types of genetic testing?

  • Direct-to-consumer genetic testing (DTC-GT)

  • Provider-mediated genetic testing (PM-GT)

    • Engages a healthcare professional (HCP) in a non-traditional role, i.e., HCP involvement might be limited to placing the test order or approving the order with minimal interaction/discussion with the consumer

  • Clinic-based genetic testing

    • Ordered, interpreted, and disclosed by an HCP through a traditional healthcare professional-patient relationship

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2

Describe the types of genetic testing in terms of description, who orders it, and results?

  • Direct to consumer genetic testing → HCP not involved → consumer orders test → reported directly to consumer

  • Provider mediated genetic testing → consumer initiated with HCP involved → consumer or HCP orders test → reported directly to consumer with optional access to HCP

  • Clinic based genetic testing → facilitated by HCP → HCP orders test → results facilitated by HCP

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3

In Direct to consumer testing, where are results sent to?

  • Sent to the consumers directly without clinician’s guidance

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4

What are concerns in DTC Pgx testing?

  • Concerns of test validity and quality, misinterpretation of results, and the potential for inappropriate medical decisions

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5

In 2013 FDA issued a warning to 23 and me to cease genetic tests for concerns about what? What happened in 2018?

  • 2013 FDA issued a warning letter to 23andMe, Inc., to cease marketing of genetic tests for concerns about disease susceptibility testing, pharmacogenomic testing and the potential for consumers to abandon therapy or self-manage dose adjustments based on results

  • FDA approved 23andMe’s Personal Genome Service Pharmacogenetic Report on October 31, 2018

    • Analytically and clinically valid

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6

DTC PGx test result may not be used for what?

  • DTC PGx test result may not be used for clinical decision making unless FDA-approved

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7

What are ethical issues (genetic discrimination) in PGx?

  • Overrepresentation of European ancenstry → generalizability is an issue, self reported vs continental ancestry in study enrollment, treatment guidelines of formulary

  • Genetic discrimination → set copay amounts for coverage, determine premiums

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8

What are ethical implications in PGx testing?

  • Confidentiality - sharing genetic information

    • DTC tests

    • Highly sensitive information impacting beyond the patient

  • Data use - how the genetic data will be used and shared

    • Children

      • Who should receive the results? The child, his/her legal representative, his/her doctor

      • How and what should be reported?

    • Use by Government, law-enforcement

      • Current laws only protects against employers and health insurers


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9

What are legal implications in PGx testing?

  • Health Insurance Portability and Accountability Act (HIPAA)

    • Specifies how protected health information is
      maintained and transmitted by covered entities

  • Genetic Information Nondiscrimination Act (GINA) - prohibits
    discrimination by health insurers and employers

  • How about discrimination by life insurers, lenders or other investors?

    • 2011 “CalGINA” (the California Genetic
      Information Nondiscrimination Act)- prohibits discrimination in housing and employment


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10

What does medical insurance cover?

  • Covers outpatient clinic services

  • Covers office delivered prescriptions

  • Covers most inpatient costs

    • Services

    • Drugs

  • May cover vaccines (some or all)

  • Retroactive billing

  • PGx testing falls under Medical
    Insurance

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11

What does pharmacy benefits cover?

  • Covers all outpatient drugs

  • May cover specific inpatient or clinic delivered medications

  • Do not cover inpatient drugs

  • Cover some vaccines

  • May cover MTM or other pharmacy cognitive services

  • Upfront adjudication

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12

For medical benefit review of PGX, what is the focus on?

  • Focus is on:

    • Is PGX testing likely to reduce number of clinic visits?

    • Does PGX prevent potential serious adverse events?

    • Can successful treatment option be chosen without PGX?

    • How long will it take for the medical benefit to recoup the testing costs?

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13

For pharmacy benefit review of PGX what is the focus on?

  • Focus is on:

    • Are the results of the test likely to result in the use of a non-preferred agent?

    • Will the test require that patient uses a high cost, brand-name only medication?

    • Do the results of the test require long-term use of a high-cost agent?

    • Are there alternative assessments to better evaluate appropriateness of a prescription drug?

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14

Do all insurance companies cover PGx testing?

  • No

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15

How has PGx testing historically been viewed as what?

  • PGx testing has historically been viewed as non-essential testing outside of oncology

    • You can prescribe a medication without PGx testing

    • If a safety or effectiveness issue arises, drugs can be switched

    • Many patients will receive proper medication without PGx testing

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16

What Is a barrier in PGx testing?

  • Significant complexity in coverage as barrier

    • PGx testing is typically thought of as a lab test (medical benefit)

    • PGx testing primarily impact drug prescribed (prescription benefit)

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17

For medicare and medical, how are test grouped? Which tests are covered?

  • Tests are grouped into Tiers

  • Tests which are Tier 1 are covered by Medicare and Medical (CMS)


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18

Standard programs cover PGx testing under what?

  • The medical benefit

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19

Coverage is limited to what based on evidence reviews? For example what does Aetna cover and not cover?

  • Coverage limited to certain drug-gene pairs based on evidence review

    • Aetna covers:

      • CYP2C19 for clopidogrel

      • Tumor biomarkers

    • Aetna Does NOT cover:

      • CYP2D6 for donepezil

      • CYP2D6 for beta blocker choice

      • Other P450 polymorphisms


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20

What are barriers to PGx testing in a medical benefit?

  • Unless you implement, you can’t prove financial benefit. If you don’t have evidence of financial benefit, less likely to be implemented

  • Few utilization management strategies to encourage testing

    • Cost utility, cost benefit, cost effectiveness analysis

  • Testing is largely left to provider discretion

  • Medical benefits do not have strategies built to require testing before prescribing

  • Historically there have been few links between pharmacy and medical benefit

    • Makes it difficult to restrict reimbursement per drug

    • Require pre-authorization before running a test

    • Easier for insurers to restrict payment than encourage

      • Slows process

      • May result in limited use

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21

For cost analysis of PGx testing, how are multiple budgets impacted?

  • Prescription drug costs impacts PBM budget

  • Cost of lab test impacts medical benefit budget

  • Theoretic savings typically impacts medical benefit budget

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22

For cost analysis of PGx testing, return on investment requires company to what?

  • Be focused on total cost of care

  • Be able to link medical and pharmacy benefit

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23

For implementing a PGx testing program, how it it currently managed?

  • Health system level

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24

How should a system implement testing process to occur?

  • At diagnosis/assessment of need

  • Prior to a medication being prescribed

    • Need to ensure patient understands results of test and its implication

    • Ensure pharmacist is engaged in the process


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25

What is the PA approach to implement pharmacogenomics testing?

  • 1.) Prescription is ordered

  • 2.) Patient tries to pick up prescription

  • 3.) PBM denies coverage and requires PA

  • 4.) PA informs prescriber that a pharmacogenomic test is required first

  • 5.) Pt sent pharmacogenomic test or returns to clinic

  • 6.) Test result come back

  • 7.) Results are reviewed by someone (who?)

  • 8.) Rx approved or denied based on results

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26

The patient impact of PGx testing can result in what?

  • Increased lab costs (depending on if they pay for labs)

  • Increased out of pocket cost for medications

    • Plavix is available generically and comes with Tier 1 copayment /coinsurance

    • Effient is now available as generic prasugrel and comes with Tier 2 copayment/coinsurance

    • Brilinta is available brand name only, which typically require either PA or Tier 3 copayment/coinsurance

  • May cause patient delays in starting therapy

  • Places increased burden on the patient


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27

What are barriers to implementing PGx?

  • Lack of sufficient knowledge of PGx

  • Minimal PGx training for healthcare providers other than pharmacists

  • Added cost of PGx testing (lack of insurance coverage)

  • Lack of actionable guidelines for drug selection and dosing using PGx

  • Lack of consistency in PGx testing and reporting

  • Lack of informatics infrastructure to integrate PGx data with other clinical data


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