Nevada § 422.4032 - Exemption from required step therapy for certain drugs: Application process; form; approval; payment of cost of drug for which exemption applies

§ 422.4032. Exemption from required step therapy for certain drugs: Application process; form; approval; payment of cost of drug for which exemption applies

1. The Department or a pharmacy benefit manager or health maintenance organization

with which the Department contracts pursuant to NRS 422.4053 to manage prescription drug benefits shall allow a recipient of Medicaid who has

been diagnosed with stage 3 or 4 cancer or the attending practitioner of the recipient

to apply for an exemption from step therapy that would otherwise be required pursuant

to NRS 422.403 to instead use a prescription drug prescribed by the attending practitioner to treat

the cancer or any symptom thereof of the recipient of Medicaid. The application process must: (a) Allow the recipient or attending practitioner, or a designated advocate for the

recipient or attending practitioner, to present to the Department, pharmacy benefit

manager or health maintenance organization, as applicable, the clinical rationale

for the exemption and any relevant medical information. (b) Clearly prescribe the information and supporting documents that must be submitted

with the application, the criteria that will be used to evaluate the request and the

conditions under which an expedited determination pursuant to subsection 4 is warranted. (c) Require the review of each application by at least one physician, registered nurse

or pharmacist. 2. The information and supporting documentation required pursuant to paragraph (b)

of subsection 1: (a) May include, without limitation: (1) The medical history or other health records of the recipient demonstrating that

the recipient has: (I) Tried other drugs included in the pharmacological class of drugs for which the

exemption is requested without success; or (II) Taken the requested drug for a clinically appropriate amount of time to establish

stability in relation to the cancer and the guidelines of the prescribing practitioner;

and (2) Any other relevant clinical information. (b) Must not include any information or supporting documentation that is not necessary

to make a determination about the application. 3. Except as otherwise provided in subsection 4, the Department, pharmacy benefit

manager or health maintenance organization, as applicable, that receives an application

for an exemption pursuant to subsection 1 shall: (a) Make a determination concerning the application if the application is complete,

or request additional information or documentation necessary to complete the application

not later than 72 hours after receiving the application; and (b) If it requests additional information or documentation, make a determination concerning

the application not later than 72 hours after receiving the requested information

or documentation. 4. If, in the opinion of the attending practitioner, step therapy may seriously jeopardize

the life or health of the recipient, the Department, pharmacy benefit manager or health

maintenance organization that receives an application for an exemption pursuant to

subsection 1, as applicable, must make a determination concerning the application

as expeditiously as necessary to avoid serious jeopardy to the life or health of the

recipient. 5. The Department, pharmacy benefit manager or health maintenance organization, as

applicable, shall disclose to a recipient or attending practitioner who submits an

application for an exemption from step therapy pursuant to subsection 1 the qualifications

of each person who will review the application. 6. The Department, pharmacy benefit manager or health maintenance organization, as

applicable, must grant an exemption from step therapy in response to an application

submitted pursuant to subsection 1 if: (a) Any treatment otherwise required under the step therapy or any drug in the same

pharmacological class or having the same mechanism of action as the drug for which

the exemption is requested has not been effective at treating the cancer or symptom

of the recipient when prescribed in accordance with clinical indications, clinical

guidelines or other peer-reviewed evidence; (b) Delay of effective treatment would have severe or irreversible consequences for

the recipient and the treatment otherwise required under the step therapy is not reasonably

expected to be effective based on the physical or mental characteristics of the recipient

and the known characteristics of the treatment; (c) Each treatment otherwise required under the step therapy: (1) Is contraindicated for the recipient or has caused or is likely, based on peer-reviewed

clinical evidence, to cause an adverse reaction or other physical harm to the recipient;

or (2) Has prevented or is likely to prevent the recipient from performing the responsibilities

of his or her occupation or engaging in activities of daily living, as defined in 42 C.F.R. § 441.505 ; or (d) The condition of the recipient is stable while being treated with the prescription

drug for which the exemption is requested and the recipient has previously received

approval for coverage of that drug. 7. If the Department, pharmacy benefit manager or health maintenance organization,

as applicable, approves an application for an exemption from step therapy pursuant

to this section, the State must pay the nonfederal share of the cost of the prescription

drug to which the exemption applies. The Department, pharmacy benefit manager or health maintenance organization may

initially limit the coverage to a 1-week supply of the drug for which the exemption

is granted. If the attending practitioner determines after 1 week that the drug is effective

at treating the cancer or symptom for which it was prescribed, the State must continue

to pay the nonfederal share of the cost of the drug for as long as it is necessary

to treat the recipient for the cancer or symptom. The Department, pharmacy benefit manager or health maintenance organization, as

applicable, may conduct a review not more frequently than once each quarter to determine,

in accordance with available medical evidence, whether the drug remains necessary

to treat the recipient for the cancer or symptom. The Department, pharmacy benefit manager or health maintenance organization, as

applicable, shall provide a report of the review to the recipient. 8. The Department and any pharmacy benefit manager or health maintenance organization

with which the Department contracts pursuant to NRS 422.4053 to manage prescription drug benefits shall post in an easily accessible location

on an Internet website maintained by the Department, pharmacy benefit manager or health

maintenance organization, as applicable, a form for requesting an exemption pursuant

to this section. 9. As used in this section, “ attending practitioner ” means the practitioner, as defined in NRS 639.0125 , who has primary responsibility for the treatment of the cancer or any symptom of

such cancer of a recipient.