Running tests

Getting a sample

There are several ways that a patient can be tested with Macula Risk:

• The patient can be sampled in your office. Either the patient or the office staff can take the sample
• A patient can be referred to another local provider of the test. Contact us to find the most convenient location for you
• Some clinics have very high volumes of patients being tested, and have dedicated staff (Macula Risk Patient Services Technicians [PST's]) to help administer the test. Click here to schedule an appointment with a PST

For detailed instructions on how to collect a sample, please click here

Filling in the 1 page Test Requisition Form (TRF)

To qualify for re-imbursement, a patient must be diagnosed with AMD (whether Early, Intermediate or Advanced). One of the following ICD-9 diagnostic codes must be present:

The TRF must be completed to prevent processing delays at the laboratory. Photocopy the front and back of the patient's insurance card. Remember to discuss and acquire the patient's informed consent.

Shipping

Once both swabs are inside the Biohazard bag, remember to fill out the label on the front of the bag. The completed bag, together with the white copy of the TRF and insurance photocopies, are put inside the padded envelope and sealed. Overpacks are included in all kits in case you are shipping 2+ test samples.

Call FedEx 1 (800) 463-3339 to pick up the pre-paid / pre-addressed packs. Samples should be picked up on a weekly basis. This recommendation is based on keeping the office organized, not sample stability; as samples are stable for 1 year.

Interpreting Macula Risk Results

The patient report will be sent via fax and mail approximately 3 weeks after shipment. Page 1 contains the Macula Risk score as well as the detailed breakdown of the patients' genetics. Pages 2-5 contain information on test interpretation, details and references.

Macula Risk categorizes people into 5 levels of risk. The risk level is determined by an algorithm that takes into account the different markers associated with the Macula Risk test as well as the patient's smoking history. Risk levels 3, 4 and 5 represent 20% of people — they have a higher than average risk for vision loss from AMD.

Sample Risk Reports

Reimbursement & Privacy

Macula Risk is reimbursed by most insurers, including Medicare, for patients who have a diagnosis of AMD and valid insurance. Macula Risk is not recommended for those without an AMD diagnosis. Un-insured patients and those with no signs of AMD (no ICD-9 code) will be required to send a payment by check or credit card to the laboratory with their sample.

Medicare charges no deductibles or co-pays for laboratory tests.

Macula Risk^® is reimbursed when ordered with the following ICD9 codes:

ICD 9 CODES

• 362.50 (non-specific AMD)
• 362.51 (nonexudative senile macular degeneration)
• 362.52 (exudative senile macular degeneration)
• 362.57 (drusen)

Patient Payments: The only patient that will need to pay for the test is one who has no valid diagnosis (see above) or insurance coverage. This payment must occur at the time of testing.

Macula Risk Genetic Counseling

Genetic counseling is recommended for all genetic testing, including Macula Risk. There are free full-time certified genetic counsellors available for you or your patients, as required. To schedule a teleconference with a genetic counsellor to discuss Macula Risk testing, please begin by directing your inquiry to:

Janet Talbert, MS, CGC (TalbertJ@NJHealth.org)
Certified Genetic Counselor

PRIVACY

For those concerned with how insurance companies or employers might discriminate against patients who are tested please note that the Genetic Information Non-discrimination Act (GINA) was approved by US Congress in 2008. This legislation protects patients from third party discrimination based on genetic testing information.