RE: Consideration of compliance clearance to offer educational training and at-risk screening through medical practices.

"PGx America's At-Risk Outreach Program"

Pharmacogenomics (referred to as PGx) testing is indicated as a predictor of Adverse Drug Reactions and other Acquired Conditions.  This simple, inexpensive cheek swab genetically indicates how drugs metabolize and interact within an individual.   While PGx is simple to administer and medically necessary, it can seem daunting so PGx America is offering new practices the "At-Risk Outreach Program" to help practice personnel learn while PGx America staff ad    minister this vital genetic screening to the most at-risk of patients.  At-Risk is determined using CMS guidance on both number and nature of drugs as well as a patient’s particular malady.

 Here is how the program works:

 -Upon acceptance as a PGx Clinic, entire staff will be enrolled in PGx University, a weeklong series of short email lessons designed to gently expand staff understanding of this test.  

 -Our Medical Director will spend a few minutes with office staff identifying those patients whom CMS guidance indicates are at least 80% likely to have an Adverse Drug Reaction.

 -A PGx America staffer will call those determined by the practice as most at-risk and schedule them to come in for this 20-second mouth swab. Our staffer will thoroughly explain the test, answering all questions.  

 -On Day One a PGx clinician and a billing expert will come to your practice and administer the test to up to 50 patients.  From the time we take the patients back to the exam room, through the paperwork, to putting the samples in a Fedex bag for the lab, our people perform functions as the staff watches and learns.  The only staffing requirement will be requesting a practice member to actually stick the swab in the patient’s mouth for 20 seconds per side to encourage participation.   A few hours later practice staff will be on the sharpest edge of diagnostic science by watching and learning.

 -The billing specialist then teachs  staff proper charting to assure transparent and compliant billing.

 -PGx America affliated labs will forward test results to other providers prescribing medications to patients including consultations on those results with written authorization from patients.

  "At-Risk Outreach" days may continue to be scheduled as long as a practice feels it is needed as an educational program for staff, ensuring the most vulnerable of patients are leaving offices safer from Adverse Drug Reactions. 


Our company always values compliance as the first priority.  It is in that spirit that we constantly review any revenue programs assuring us of conformity to regulations and ethics.

To assure our providers are compliant with all ethical and regulatory guidelines we submit all potential revenue components to the Dept. Of Health & Human Services.  This is the submitted description of our fast-start program to ensure the health of your most at risk patients.