PURPOSE OF THE POLICY To establish a process and guidelines for requests of Medical Exception, Tier Exceptions and Coverage Determinations on non-formulary and formulary Medicare Part D drugs including those with Utilization Management requirements. STATEMENT OF THE POLICY Health Alliance Medical Plans will establish a process and guidelines for requests of Medical Exception, Tier Exceptions and Coverage Determinations on drugs not included on the Medicare Part D Formulary for Medicare Part D Members, as well as those Part D drugs on the formulary and those which may have utilization management requirements. PROCEDURES 1. Criteria for Medical Exception 1.1 Documented failure of all formulary medications (and generic equivalent if a multi-

source brand) within the same therapeutic class OR 1.2 Documented allergy to a formulary medication (and generic equivalent if a multi-source

brand), with no other formulary options. 1.3 Patient is successfully maintained on a specific drug entity within select drug classes

where switching to an alternative entity may cause a health risk: • Antiarrhythmics • Theophylline products • Seizure medications • Antipsychotics • Antidepressants • Antiretrovirals • Antineoplastics • Immunosupressants (for prophylaxis of organ transplant rejection)

2. Criteria for Tier Exceptions (for Open and Closed formulary) 2.1 Same criteria as outlined above. 2.2 Tier 2 Generics are eligible for tier lowering to Preferred Generic Tier (Tier 1). 2.3 Non-preferred Drugs (brand and generic) are eligible for tier lowering to Preferred Brand

Tier (Tier 3) only. 2.4 Certain high cost Part D drugs such as genomic and biotech drugs which are classified as

Specialty Medications on the Medicare Part D Formulary are not subject to review for tiering exceptions.

2.5 Non-formulary drugs that have been approved under the formulary exception process are not eligible for tier exception

3. Criteria Used To Determine Medical Necessity Include 3.1 FDA labeling 3.2 Evidence-based practice guidelines

3.3 Standards of medical practice 3.4 A physician’s statement must document reasons why formulary/preferred products cannot

be used for the enrollee. Reasons could include contraindications, previous adverse reactions, or because the formulary/preferred products would be less effective.

4. Process for Medical Exception/Coverage Determination 4.1 Health Alliance will promptly determine if a complaint or Prior Authorization request is

standard coverage determination or an expedited coverage redetermination. The pharmacist who reviews the Prior Authorization request will also determine if the request is for a routine Prior Authorization request or a request for an exception to the approved criteria. Pharmacy maintains a toll-free call center to respond to members, physicians and other providers for information related to exceptions and prior authorizations. To request a Medical Exception for a medication on behalf of a member, or to request further information, please call Health Alliance at 1-800-851-3379, extension #8048, or fax the Preauthorization/Medical Exception form to (217) 255-4598.

4.2 Information required when requesting a Medical Exception include: • Patient name and Health Alliance identification number • Physician name or other authorized prescriber, address, and phone number • Drug name and strength • Patient diagnosis • Chart documentation / documentation of previous medical history pertaining to the

requested drug • Pharmacy name and phone number • If granted Medical Exception, then medication will be adjudicated with a Non-

Preferred Brand co-payment 4.3 Members of Long Term Care Facilities will be granted a 30 day supply of the medication

at Non-Preferred Brand co-payment, while filing for Medical Exception 4.4 All after business hours and weekend requests for Expedited coverage determinations will

be handled by Health Alliance’s Pharmacy Benefit Manager, OptumRx’s helpdesk. They will make coverage determinations based on Health Alliance’s policy and procedures.

4.5 Member inquiries to the Pharmacy toll-free call center about appeals will be communicated to the appropriate personnel to be reviewed in accordance with the Medicare Advantage Reconsideration Appeals Process for Medicare Part D (Prescription Benefit) policy. Appeals to the decision may be made by contacting Health Alliance at 1-800-851-3379 extension 8048.

5. Notification and Timeframes 5.1 Standard benefit coverage or exception request

• Member and physician or other authorized prescriber will be notified by mail using approved notice language stating specific reasons for denial and provide rights for redetermination, and by fax within 72 hours after receipt of request, or, for exceptions request, from receipt of the physician’s or other authorized prescriber’s supporting documentation.

5.2 Expedited benefit coverage or exception request • Member and physician or other authorized prescriber will be notified by phone no

later than 24 hours after receipt of request, or, for an exceptions request, from receipt of the physician’s or other authorized prescriber’s supporting documentation

• When an expedited coverage determination is not granted, Health Alliance will promptly provide written notice of denial within 72 hours in compliance with CMS requirements including the process of requesting the 72 hour timeframe for standard determination, inform of right to file expedited grievance, inform of right to resubmit

request for expedited determination with physician’s or other authorized prescriber’s supporting documentation and provide instructions on grievance.

5.3 Standard Re-determinations • Member and physician or other authorized prescriber will be notified by mail and/or

fax, using approved notice language stating specific reasons for denial and provide rights for determination, as expeditiously as the enrollee’s health condition requires, but no later than seven (7) calendar days from receipt of request.

5.4 Expedited Re-determinations • Member and physician or other authorized prescriber will be notified by mail and/or

fax, using approved notice language stating specific reasons for denial and provide rights for determination, as expeditiously as the enrollee’s health condition requires, but no later than 72 hours after receiving the request.

5.5 Health Alliance will forward the enrollee’s request to the Independent Review Entity (IRE) within 24 hours of the expiration of the appropriate adjudication timeframe if a decision could not be made to the following address:

Maximus Federal Services, Inc. Medicare Reconsideration Project 50 Square Drive, Suite 210 Victor, New York 14565

5.6 For favorable determinations, Health Alliance will make payment within 30 calendar days after receiving the request or, for an exceptions request, after receiving the physician’s or other authorized prescriber’s supporting documentation.

6. Tier & Quantity Override Exception Process

• Tier & quantity override exceptions have the same process as above. Only those medications which are on the Medicare Part D formulary at a Non-preferred Tier are eligible for Tier lowering. Certain high cost Part D drugs such as genomic and biotech drugs which are classified as Specialty Medications on the Medicare Part D Formulary are not subject to review for tiering exceptions.

7. Emergency Supply for an Exception Medication After Hours and On Weekends 7.1 A five (5) day supply, with no copay, will be overridden by the Pharmacy Benefit

Manager, Medimpact, in the event a Medicare Part D Member requests an emergency supply of an exception medication after hours and on weekends.