Background
On June 11, the Centers for Medicare & Medicaid Services (CMS) posted a future Local Coverage Determination (LCD) for Molecular Diagnostic Services Program (MoIDX): Pharmacogenomics Testing.The LCD, which includes broad coverage for pharmacogenomic (PGx) testing, will take effect on July 26, 2020.
LCD Coverage
The LCD covers single gene, multi-gene panels, and combination tests used to “improve safety in the use of specific medications by avoiding potentially harmful medications, doses, and/or adverse reactions.” Per the LCD, PGx tests are “indicated when medications are being considered for use (or already being administered) that are medically necessary, appropriate, and approved for use in the patient’s condition and are known to have a gene(s)-drug interaction that has been demonstrated to be clinically actionable as defined by the FDA (PGx information required for safe drug administration) or Clinical Pharmacogenetic Implementation Consortium (CPIC) guidelines (category A and B).” CMS notes that a diagnosis alone will not be a sufficient basis to order PGx testing.
To receive coverage, CMS requires that the PGx test be reasonable and necessary. Further, CMS requires that the PGx test undergo “technical assessment” that demonstrates clinical and analytical validity as well as clinical utility. Coverage is also contingent on the following documentation in a patient’s electronic health record:
- “The patient has a diagnosis for which pharmacologic therapy is reasonable and necessary, and the drug or drugs that the clinician is considering using must be reasonable and necessary for the treatment of the patient’s diagnosis.
- The clinician has made an initial personalized decision for the patient based on the patient’s diagnosis, the patient’s other medical conditions, other medications the patient is taking, professional judgement, clinical science and basic science pertinent to the drug (e.g. mechanism of action, side effects), the patient’s past medical history and when pertinent family history and the patient's preferences and values.
- The provider performing the service must have a record of what drug(s) is/are being considered and for what indication(s) to ensure the test performed is reasonable and necessary.”
The LCD does not specifically address whether pharmacists can order pharmacogenomics tests (PGX), but the LCD requires that the ordering provider have the “licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and also to prescribe medications for the condition either independently or in an arrangement as required by all the applicable state laws.” CMS’s reference to diagnosis suggests that pharmacists may not be able to independently order PGX tests at present. However, based on education and skills, pharmacists are uniquely qualified to engage in ordering PGX tests and for reporting and interpreting test results.
Next Steps
ASHP remains committed to advocating for pharmacist engagement in, and reimbursement for, medication management informed by PGX testing. ASHP will urge CMS to clarify that pharmacists can order and administer PGX tests and will urge states to expand their scopes of practice to include PGX testing. Additionally, ASHP co-chairs two GTMRx workgroups which focus on precision medicine, and PGx payment and policy. We will work through GTMRx to advocate for expanded coverage for pharmacogenomics testing and related comprehensive medication management..