The ProMark Certification and Training Registry (CTR) has been established to enable Medicare coverage for eligible patients. Under Local Coverage Determination (LCD) L36665, the ProMark test is considered "reasonable and necessary" for Medicare patients meeting identified coverage criteria and when ordered by a physician certified in the CTR.
1. Provider Certification
- Carefully review all ProMark Assay CTR program documents.
- Complete necessary training online at www.promarktest.com
- Sign Healthcare Provider Certification.
- If you opt out using an electronic signature within www.promarktest.com please print, sign and either give the form to your Metamark Genetics representative, email to ProMarkCTR@metamarkgenetics.com.
2. ProMark Assay Testing
- Patients should be counseled on the benefits and risks of the ProMark assay.
- Test results should be appropriately explained to the patient.
- The need for continued, appropriate monitoring should be explained to the patient.
- Schedule and document patient's medical record appropriate follow-up visits, tests and procedures for patients tested under ProMark CTR.
3. Data Reporting
- For patients who were deemed Low-risk by the assay and did not receive treatment, the provider should report:
- Prostate Cancer Progression
- Prostate Cancer Metastasis
- Prostate Cancer Specific Mortality
- Complete the Adverse Event Report and submit it to Metamark Genetics.
4. Program Compliance
- The LCD requires registered healthcare providers to comply with all obligations of the ProMark CTR in order to maintain their certification.
- As sponsor of the ProMark CTR, Metamark Genetics may contact you from time-to-time to assist you with your continued compliance with the ProMark CTR.
- In the event of a continued failure to remain in compliance with the terms of the LCD and the ProMark CTR, Metamark Genetics is charged with taking appropriate measures to bring registered healthcare providers into compliance, including by instituting corrective actions up to and including de-certification.