Patient must have a demonstrated history of treatment adherence.
Prior authorization must be obtained from the Council of Community Clinics on the Ryan White Care Act / HIV Resistance Testing Program Request (Attachment B) before ordering the test. The Council of Community Clinics will not pay the laboratory for unauthorized tests. The lab will bill your clinic for the full cost of the test.
Once authorization is obtained, draw the patient's blood per the detailed instructions below and submit it with a completed ViroLogic requisition form (Attachment D). The authorization number received from the Council of Community Clinics must be written in the comments section of the form. The top copy must accompany the specimen to ViroLogic, while the bottom copy is for your records.
Detailed Instructions:
Ryan White CARE Act / HIV Resistance Testing Program Request, Part A
Part A of the form must be completed and faxed to the Council of Community Clinics for authorization before ordering the test.
Identification
Please write the patient's basic identifying information and your contact information in the top section. Enter the patient's most recent CD4 count and viral load with their respective test dates below. Be sure to indicate whether the viral load was obtained with a PCR or b-DNA assay. Also indicate the client's ethnicity, home geographic region of the county, risk status and case management status.
Treatment History
Please mark the patient's current antiretroviral regimen in the first column (1), any previously taken antiretrovirals (2), and your proposed regimen in the third column (3). Include medications that were used for seven days. If a medication is not listed, please write it in the space below and indicate whether it is in the patient's current, past or proposed regimen. Please also indicate the date the patient's current regimen was started.
Requested Assay
PhenoSense is available in 12- and 15-drug versions. The 12-drug Select version costs $750 and tests Ziagen (abacavir), Videx (didanosine/ddI), Epivir (lamivudine/3TC), Zerit (stavudine/d4T), Retrovir (zidovudine/AZT), Sustiva (efavirenz), Viramune (nevirapine), Agenerase (amprenavir), Crixivan (indinavir), Viracept (nelfinavir), Norvir (ritonavir) and Fortovase (saquinavir).
The 15-drug Comprehensive version costs $930 and also tests Preveon (adefovir), Hivid (zalcitabine/ddC) and Rescriptor (delavirdine). Preveon is still under review in Europe but will likely be removed from the test within the next few months.
Limited funding requires us to restrict clients to one phenotypic resistance test per year. You may order the 12- or 15-drug panel at your discretion, but the Office of AIDS Coordination asks that you consider ordering the 12-drug version to maximize the number of tests that may be offered.
Other Funding Sources
Some clinics have had success in convincing private insurers to pay for resistance testing. If your patient has private insurance, document their medical need for testing in as much detail as possible and approach their insurer before contacting the Council of Community Clinics. If denied, check the appropriate box on the Ryan White CARE Act / HIV Resistance Testing Program Request form and attach any Explanations of Benefits or other denial forms.
Optional Consultation
Consultations are available with staff of the local AIDS Education and Training Center antiviral therapy program. Please review Attachment C for information about what services are offered. If interested in a free, no-obligation consult, please check the appropriate box.
Signature
Sign and date the form to certify that your patient meets both the letter and spirit of the resistance testing guidelines approved by the Planning Council.
Once Part A of the form is completed, fax it to the Council of Community Clinics at (619) 265-9011. To ensure quick turnaround, please call the Council's resistance testing program coordinator at (619) 265-2100 x308 as you send the request form. The coordinator will verify that your patient meets the eligibility guidelines, assign your request an authorization number and fax the form back to you. Once you have the authorization number, complete the requisition form.
ViroLogic PhenoSense Requisition Form
Your clinic information will be pre-printed on the requisition form. Enter the patient's name, date of birth and gender. The SSN/Unique Identifier field can be used for the patient's medical record number if you choose.
Indicate your choice of the 12- or 15-drug tests, as well as the patient's most recent viral load (result and date of test). Be sure to write the Council of Community Clinics authorization number in the Comments section of the requisition. The Council will not pay the lab without this number and your clinic will receive the bill.
Indicate the patient's most recent CD4 count and the date of the test, and complete the Current Treatment section of the requisition. Also indicate the patient's race/ethnicity and all previous treatment regimen(s). Enter the dates the patient started and stopped taking each medication.
Specimen Collection and Preparation
Draw whole blood in sterile tubes containing EDTA as the anticoagulant (lavender top). Centrifuge unfrozen blood within six hours of collection, at 1000-1200g at room temperature for 10-15 minutes. Remove the plasma immediately after separation (3mL requested, 2mL absolute minimum) and transfer to an 8mL screw-top polyethylene tube, preferably one with an O-ring seal. PPT's are acceptable if in-house separation is not possible. Plasma samples or PPTs must be frozen immediately and maintained at or below -20°C. Record the date and time of collection and freezing on the requisition form.
Once the sample is frozen, call ViroLogic customer service at (800) 777-0177 and request a pickup. The office is open Monday through Friday, 8 a.m. - 6 p.m., and same-day pickup is available if you call before 2 p.m. The courier will have dry ice and all necessary shipping materials. If you choose to ship samples on your own, contact ViroLogic customer service for packing materials and all necessary forms. Samples must be shipped frozen on dry ice.
Turnaround and Billing
ViroLogic will fax and mail the test results within two weeks of sending in the specimen. A sample report is included as Attachment E. ViroLogic will bill the Council of Community Clinics for the test using the authorization number received for the Council. If you do not obtain an authorization number before requesting a test, your clinic will be liable for the cost of that test.
Ryan White CARE Act / HIV Resistance Testing Program Request, Part B
Please order new CD4 and viral load tests between four and eight weeks after the patient has begun his or her new regimen. Record the results on Part B of the Ryan White CARE Act / HIV Resistance Testing Program Request form, note the patient's new regimen and the date the patient started the regimen in the appropriate spaces, and fax the form to the Council of Community Clinics at (619) 265-1417. If you requested a consult with the AIDS Education and Training Center, indicate if their recommendations were used.
