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
c.
To authorize no more than a six-month supply of the
drug, including the original prescription order and all
refills;
2.
Submit:
a.
A written prescription order or copy of a written
prescription order to the Department as specified in
R9-6-404(A)(3);
and
b.
A written or oral prescription order to the vendor
pharmacy when:
i.
Prescribing a drug for a newly enrolled
individual,
ii.
Prescribing a new drug for an enrolled individual,
or
iii.
Authorizing an additional six-month supply of a drug
for an enrolled individual; and
3.
Notify the vendor pharmacy when discontinuing a
drug for an enrolled individual.
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 forward a written prescription
order submitted to the Department as specified in subsection (A)(2)(a) to the
vendor pharmacy within three business days of approving an individual for
initial enrollment.
C.
The vendor pharmacy shall:
1.
Maintain a supply of the drugs on the ADAP formulary
available for dispensing;
2.
Receive prescription orders issued by an enrolled
individual's primary care provider;
3.
Before dispensing drugs, verify:
a.
With an enrolled individual or the enrolled
individual's representative the address to which the enrolled individual or the
enrolled individual's representative wants the drugs delivered,
and
b.
An individual's enrollment status;
4.
Dispense up to a 30-day supply of a drug to an
enrolled individual:
a.
Upon receipt of a:
i.
Prescription order as specified in subsection
(C)(2), or
ii.
Request from the enrolled individual or the
enrolled individual's representative for a refill of the drug;
b.
To the address identified, as specified in
subsection (C)(3)(a); and
c.
So the drug is dispensed to the enrolled individual
no later than three business days after the vendor pharmacy:
i.
Receives a prescription order or request for
refill, as specified in subsection (C)(4)(a);
ii.
Has verified the address to which the drug is to be
delivered, as specified in subsection (C)(3)(a); and
iii.
Has verified the individual's enrollment status, as
specified in subsection (C)(3)(b); and
5.
Notify the Department upon receiving a request for
dispensing a drug for an individual who is neither enrolled nor provisionally
enrolled in 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).
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.
E.
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;
f.
g. A justification for
use of the
drug that is not on the
ADAP formulary by the enrolled individual;
g.
An attestation by the primary care provider that:
i.
To the best of the primary care provider's knowledge
and belief, the information presented in the request is accurate and complete;
and
ii.
The primary care provider understands that the
primary care provider is required to provide instructions to the enrolled
individual regarding the use of the restricted drug and monitor the enrolled
individual's use of the restricted drug;
h. Whether the Department should consider
adding the drug to the ADAP formulary and the reasons for the recommendation;
and
h.
i. The dated signature of the
HIV-care provider;
i.
An attestation by the enrolled individual or the
enrolled individual's representative that the enrolled individual or the
enrolled individual's representative understands that the enrolled individual
is required to:
i.
Follow the instructions of the enrolled individual's
primary care provider regarding the use of the restricted drug; and ii. Have
periodic laboratory analyses performed to support continuing use of the
restricted drug; and
j.
The dated signature of the enrolled individual or
the enrolled individual's representative;
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).
a.
The completed drug-specific form specified in
subsection (E)(1), and
b.
Copies of the results of the most recent laboratory
analyses to support the request for the restricted drug.
F.
If the restricted drug requested under subsection
(E) is approved by the Department for an enrolled individual, the enrolled
individual's primary care provider shall:
1.
Provide instructions to the enrolled individual
regarding the use of the restricted drug; and
2.
Monitor the enrolled individual's use of and
clinical response to the restricted drug.
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
c.
The vendor pharmacy.
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).
