Ariz. Admin. Code § 9-6-409

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-6-409 - Drug Prescription and Distribution Requirements

A. A primary care HIV-care provider shall:

1. Issue a prescription order:

a. For each drug on the ADAP formulary prescribed for an applicant or enrolled individual by the HIV-care provider; and

b. For dispensing up to a 30-day supply of the drug; and

2. Provide a written prescription order to the applicant or enrolled individual or an electronic prescription order to the contract pharmacy or a pharmacy at which the applicant or enrolled individual may request a drug through ADAP.

B. The Department shall:

1. Except as specified in subsection (D), provide up to a 30-day supply of a drug to an enrolled individual; and

2. Ensure that a drug to be shipped to an enrolled individual is sent to the address in Arizona provided by the enrolled individual according to R9-6-404(A)(1)(d) or R9-6-407(B)(1)(d).

C. The Department may authorize replacement of a drug when:

1. The drug has been dispensed by the contract pharmacy or a pharmacy in which the enrolled individual or the enrolled individual's representative requested a refill of the drug through ADAP ; and

2. The enrolled individual or the enrolled individual's representative claims the dispensed drug was lost, stolen, or damaged.

D. The Department may authorize an enrolled individual to receive more than a 30-day supply of a drug if the enrolled individual:

1. Submits to the Department:

a. The enrolled individual's name and date of birth;

b. The number of days for which the enrolled individual is requesting a supply of the drug; and

c. A justification for receiving more than a 30-day supply of a drug, such as that:

i. The enrolled individual will be out of Arizona for more than 30 days without changing residency, or

ii. The enrolled individual's health insurance coverage will allow for more than a 30-day supply of a drug; and

2. Is expected to continue to be enrolled in ADAP:

a. Past the number of days for which the enrolled individual is requesting a supply of the drug, and

b. Without needing to submit information or documentation for continuing enrollment, according to R9-6-407(E) or (F), during the time period.

E. For an enrolled individual who has health insurance coverage, the HIV-care provider of the enrolled individual, independently or through the contract pharmacy, may request approval of a drug on the ADAP formulary that is not covered by the enrolled individual's health insurance by submitting to the Department documentation that:

1. The drug is not covered by the enrolled individual's health insurance,

2. A request for health insurance coverage of the drug as a medical exception has been denied by the enrolled individual's health insurance, and

3. An appeal of the denial of the request in subsection (E)(2) has been denied by the enrolled individual's health insurance.

F. The HIV-care provider of an enrolled individual, independently or through the contract pharmacy, may request approval of a drug that is not covered by health insurance and not on the ADAP formulary for the enrolled individual by:

1. Providing to the Department the following information, in a Department-provided format, for each requested drug :

a. The name, business address, email address, and telephone number of the HIV-care provider;

b. The date of the request;

c. The enrolled individual's name and date of birth;

d. The name and any other identifier of the drug;

e. The cost of the drug, if available;

f. The expected duration of the enrolled individual's use of the drug, including whether:

i. Use of the drug is expected to be a one-time occurrence, or

ii. The enrolled individual is expected to need multiple refills of the drug and the expected number of refills;

g. A justification for use of the drug that is not on the ADAP formulary by the enrolled individual;

h. Whether the Department should consider adding the drug to the ADAP formulary and the reasons for the recommendation; and

i. The dated signature of the HIV-care provider;

2. Issuing a valid prescription order for the drug that is not on the ADAP formulary to the contract pharmacy; and

3. Unless the enrolled individual has no health insurance coverage, submitting to the Department the documentation required in subsections (E)(1) through (3).

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G. When the Department receives a request under subsection (E) or (F) for an enrolled individual, the Department shall:

1. Review the documents submitted according to subsection (E) or (F), as applicable;

2. Determine whether the information submitted to the Department:

a. Is complete; and

b. Substantiates that the enrolled individual's use of the drug is indicated; and

3. Notify, through the contract pharmacy, the following of the Department's decision within five working days after receiving the request:

a. The enrolled individual or the enrolled individual's representative, and

b. The enrolled individual's HIV-care provider

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H. If the Department denies a request under subsection (E) or (F) for an enrolled individual, the Department shall send to the enrolled individual or the enrolled individual's representative a written notice of denial setting forth the information required under A.R.S. § 41-1092.03.

I. The Department shall only authorize the distribution of drugs that are included on the ADAP formulary or approved for an enrolled individual according to subsection (F).

Ariz. Admin. Code § R9-6-409

Adopted effective October 19, 1993 (Supp. 93-4). Amended effective April 4, 1997 (Supp. 97-2). Former Section R9-6-409 renumbered to R9-6-902; new Section R9-6-409 renumbered from R9-6-408 and amended by final rulemaking at 8 A.A.R. 1953, effective April 3, 2002 (Supp. 02-2). Former R9-6-409 renumbered to R9-6-410; new R9-6-409 renumbered from R9-6-407and amended by final rulemaking at 13 A.A.R. 3329, effective November 10, 2007 (Supp. 07-3). Amended by final rulemaking at 25 A.A.R. 3614, effective 12/3/2019.