Provider Notice issued 11/30/12

Prior Approval Requirements for Clotting Factor

As a result of Public Act 097-0689 (pdf), referred to as the Save Medicaid Access and Resources Together (SMART) Act, the department developed a program of utilization review and control for patients with hemophilia. As part of this effort, the department will require prior approval for blood factor beginning December 10, 2012.   Each dispensing of blood factor will require prior approval before the department will reimburse a pharmacy for the product.

The requirement for prior approval will serve two distinct purposes:

• It will allow department staff to notify the treating physician when utilization patterns are indicative of clinical problems, such as excessive bleeds or non-compliance with a prophylactic dosing schedule;

• It will allow department staff to ensure that factor is dispensed in appropriate quantities so that patients have on hand a supply of factor that does not exceed that which is necessary to ensure uninterrupted therapy.

The department is committed to ensuring that this requirement is invisible to patients, and that they continue to receive appropriate services without interruption. Requests for factor will typically be reviewed within two hours of receipt. In emergency situations, when department staff are not available to make prior approval determinations, such as on weekends, pharmacies may dispense enough factor to resolve the emergency situation, and request prior approval when department staff are available. If the situation was an emergency, the department will approve the request and reimburse the pharmacy.

For the initial prior approval, the department will require that the prescriber or pharmacy provide the department with a copy of the original prescription, which includes the current dosing schedule. The department will allow the pharmacy to dispense factor, within a variance in assay to prescription/target dose that does not exceed +/- 5%, with prior approval. Approval will be for a specific date of service. Prior to each refill of the prescription, the pharmacy must request prior approval for the date of service of the refill.

Each time a prescription changes, including changes in brand of factor, dose of factor, or dosing schedule, the prescriber or pharmacy must submit a new prior approval request for the new prescription, and include a copy of the new prescription. The department is in the process of developing a prior approval request form specific to blood factor. That form will be posted on the Hemophilia Care Management Program Web page and at Pharmacy Criteria and Forms Web page.

Pharmacies are expected to do due diligence to ensure that when a client requests dispensing of blood factor, the client has utilized factor such that dispensing is appropriate. When a pharmacy requests prior approval for a refill for a client, that client should have on hand no more than a 7 day supply of factor, based on the prescription as ordered by the prescriber. If a client has missed doses, the pharmacy shall take the missed doses into account when determining the amount of factor to dispense to the client. If a client has not experienced a bleed since the prior dispensing, and the prior dispensing included doses to treat a bleed, the pharmacy shall not dispense additional factor for bleeds.

The department will soon send pharmacies a revised Standards of Care Agreement (SOCA), which will include additional requirements related to dispensing factor. Pharmacies who dispense blood factor must sign the revised agreement in order to be allowed to continue to dispense blood factor to participants in the department's Medical Assistance programs.

Any questions regarding this notice should be directed to the Bureau of Pharmacy Services at 1-877-782-5565, option 7.

Theresa A. Eagleson, Administrator

Division of Medical Programs