Roche Diagnostics introduced the AMPLICOR Patient Assistance Program (PAP) in June 1996, after receiving FDA approval for the AMPLICOR HIV-1 MONITOR Test, the first commercially available product that could accurately and precisely measure quantities of HIV-1 RNA in the blood ("viral load"). As part of the PAP, Roche offers free HIV viral load tests to patients who qualify, based on demonstrated financial need. The company is pleased to expand the PAP to include the AMPLICOR HIV-1 MONITOR UltraSensitive test. Approved by the FDA on March 3, 1999, the AMPLICOR HIV-1 MONITOR UltraSensitive test is a significant advance because it measures viral load down to 50 copies per milliliter of blood. The new test is now the most sensitive test available for measuring viral load.
The AMPLICOR PAP provides services to both patients and their providers. The first element of the program is a Reimbursement Assistance Helpline, servicing patients, their providers, and testing laboratories with important information about the handling of reimbursement claims. The second element of the program is assistance to patients and their providers in obtaining free AMPLICOR testing for patients who qualify for such testing under the PAP (see below). Another important element of the program is to assist patients in obtaining coverage for testing through alternative state, federal and local programs, if they do not qualify for free testing.
Patients can begin the application process by calling the PAP Program Administrator at 1-888-TEST-PCR (1-888-837-8727), or by submitting a completed application form directly to the Program Administrator. In most cases, application forms will be available from the patient's physician. If a patient begins the process by calling the toll-free number (Mondays through Fridays between 8:30 a.m. and 5:30 p.m. ET), a trained Program Information Specialist will ask questions such as about the patient's financial status, household size, household income, and household expenses. The Program Information Specialists can assist callers in English or Spanish.
The information gathered will assist the Program Specialist in determining the patient's possible eligibility for alternative state or federal programs. If the Program Specialist determines that a patient may be eligible for an alternative program, the patient will immediately be given the name, address and phone number of the alternative program for which he/she may be eligible. A letter to the patient will confirm this information.
If no alternative source of assistance is located during the initial screening, the patient will be eligible to apply to the PAP for free testing.
At that time, the patient will need to provide the Program with his/her physician's name and address. Within 24 hours, an application will be mailed directly to the physician. The physician will be required to complete a brief section and to forward the application to the patient for completion, and to return it to the Program Administrator for processing.
A determination of patient eligibility for free testing under the PAP can usually be made within 24 hours after receipt of a completed application. Patients who qualify for free testing will receive a letter advising him/her to contact their physician's office to arrange to obtain the AMPLICOR HIV-1 MONITOR Test or AMPLICOR HIV-1 MONITOR UltraSensitive test. At the same time, the physician will receive a letter indicating that the patient has been approved for a free test. The voucher will identify the participating laboratory to which the sample must be sent for processing. The patient will then be eligible to reapply to the program for additional testing, when such testing is recommended by his/her physician, for up to a maximum of five AMPLICOR tests annually.
If a patient's physician confirms that the patient has never received baseline testing with the AMPLICOR HIV-1 MONITOR Test, the physician will receive two vouchers to conduct baseline testing. After the baseline has been established, the patient will then be eligible to reapply to the program for additional testing, including UltraSensitive testing, for a total of five free AMPLICOR tests per year.
If the patient commences the application process by directly submitting a completed application form that he/she receives from the physician, the Program Administrator will contact the patient by phone or mail. At that time, the patient will either be asked for additional information or will be advised concerning his/her eligibility for free testing, or possible eligibility for an alternative program.