Pharmacogenetic (PGx) Testing

PGx testing may analyze genes related to:

• Pain medications like opioids
• Anticoagulants such as warfarin
• Antidepressants and antipsychotics
• Chemotherapy drugs
• Cardiovascular medications

PGx tests can be run preemptively before prescribing certain high-risk drugs. Testing may also be ordered after a patient experiences an unexpected response to medication. Samples are usually obtained with a simple cheek swab.

Billing for PGx involves coding the test ordered, specimen collection, and test analysis:

• CPT coding – The two main CPT codes for PGx testing are 81225 (CYP2D6 gene analysis) and 81226 (CYP2C19 gene analysis). Other gene-specific codes or stacked codes may also apply depending on the test.
• Diagnosis codes – Document the associated genetic susceptibility to drug response with ICD-10 code Z13.79. Also code the underlying condition for which the drug is prescribed.
• Lab versus physician billing – Labs perform the PGx analysis while doctors order the test. Confirm if your practice should bill the lab code or order code depending on arrangements with testing labs.
• Specimen collection – If collecting a specimen in-house, report CPT code 81000. You can bill for an office visit if the only purpose is PGx test collection.
• Medical necessity – Documentation must establish medical necessity through signs of adverse drug response, family history, drug dosage challenges, or preventive screening before high-risk prescribing.
  

Gaining payer coverage for PGx testing can be challenging since policies are still evolving:

• Medicare coverage – Currently, Medicare only covers pharmacogenomic testing for warfarin response under certain conditions with extensive documentation of medical necessity. Testing is not covered for other drugs.
• Private payers – Coverage varies by plan. Many insurers consider PGx experimental and will not reimburse without an appeals process. Secure pre-authorization when possible.
• Billing patients – Without insurance coverage, patients must pay out-of-pocket. Have financial consent forms clearly detailing costs ahead of testing.
• Appeals – Denied PGx claims should be appealed highlighting medical necessity and peer-reviewed evidence supporting clinical utility. Be prepared to negotiate single-case agreements with medical directors to gain approval.
• Prior authorization – Work with insurers upfront to determine coverage requirements. Prior authorization can verify reimbursement before testing.
• Patient assistance – Laboratories may offer patient assistance programs or cap out-of-pocket costs to improve access to pharmacogenomic testing.
  

PGx testing introduces additional considerations into standard revenue cycle workflows:

• Verifying insurance coverage – Check benefits to determine if PGx testing requires authorization or has coverage limitations. Alert patients if testing will be out-of-pocket.
• Coordinating authorizations – If the lab secures authorization, ensure the approved procedure and diagnosis codes match those submitted on your claim.
• Following up results – Create a process to follow up if test results recommend medication changes or dosage adjustments for the patient.
• Linking claims – If your practice orders PGx and the lab bills analysis, use matching diagnosis codes on each claim to link them for insurers.
• Managing rejections – Expect a higher denial rate for PGx testing claims. Be prepared with peer-reviewed studies, progress notes, and letters of medical necessity to support appeals.
• Patient collections – Collect estimated patient responsibility upfront before testing when not covered by insurance.
  

As PGx testing expands, medical billing processes will need to accommodate continued changes:

• Evolving payer policies – Insurers are still shaping coverage criteria and reimbursement rates for PGx testing. Stay updated on policies in your region.
• New CPT codes – More genetic testing-specific CPT codes are emerging, including stacked codes for multiple gene assays. Regularly review PGx coding guidelines.
• ICD-10 coding – Additional ICD-10 codes may develop to capture clinical details like affected drug metabolism and genetic polymorphisms.
• Lab regulation – Stricter FDA oversight of LDTs as medical devices could impact PGx labs. Follow updates on regulatory changes.
• Drug attachments – Medicare and insurers may eventually limit coverage to PGx tests tied to specific drug therapies.

As the evidence base grows, pharmacogenomic testing should gain broader reimbursement and coding options. Meanwhile, practices integrating PGx must optimize revenue cycle management through careful payer verification, detailed medical necessity documentation, and persistent appeals of claim denials.

Consider these tips to strengthen PGx billing and revenue cycle management:

• Leverage peer-reviewed evidence – Compile guidelines and clinical studies validating use of PGx testing for the specific drug therapy in question. Send this evidence to payers to justify coverage.
• Highlight clinical utility – Provide real-world examples and published data demonstrating how PGx testing changed medication selection or dosing in ways that improved patient outcomes. Concrete clinical utility aids in coverage reviews.
• Partner with labs – Work closely with PGx labs on upfront benefits investigation, prior authorizations, and appeals. Labs have experience navigating insurer policies.
• Train staff – Educate billing staff and clinicians on PGx testing guidelines, medical necessity documentation, and payer requirements to facilitate smooth claim submission.
• Appeal denials vigorously – Do not take no for an answer. Escalate appeals to medical directors. Get peer input if needed. Be relentless.
• Consider in-network options – Contract with network labs when possible. Insurers may cover PGx testing from an in-network lab at higher rates.
• Leverage genetic counselors – Get genetic counselors involved to provide documentation if insurers require their assessment before approving PGx testing.
• Enroll in clinical trials – Taking part in PGx research studies can provide patients access to free testing while building further evidence.
• Negotiate single-case agreements – Seek one-off approvals for coverage in exchange for sharing outcomes data with the payer to advance research.

As pharmacogenetic testing proliferates, following these tips can help obtain fair reimbursement, reduce claim denials, and establish positive coverage precedents with payors.