IE 4: Week 13 Ethical Legal Reimbursement

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

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

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

• Sent to the consumers directly without clinician’s guidance

What are concerns in DTC Pgx testing?

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

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

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

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

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

      
      

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

    
    

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

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

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?

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?

Do all insurance companies cover PGx testing?

• No

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

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)

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)

  
  

Standard programs cover PGx testing under what?

• The medical benefit

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

      
      

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

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

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

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

• Health system level

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

    
    

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

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

  
  

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