N.Y. Public Health Law § 274: Clinical drug review program

§ 274. Clinical drug review program. 1. In addition to the preferred

drug program established by this article, the commissioner may establish

a clinical drug review program. The commissioner may, from time to time,

require prior authorization under such program for prescription drugs or

patterns of utilization under state public health plans. When a

prescriber prescribes a drug which requires prior authorization under

this section, state public health plan reimbursement shall be denied

unless such prior authorization is obtained.

2. The clinical drug review program shall make available a twenty-four

hour per day, seven days per week response system.

3. In establishing a prior authorization requirement for a drug under

the clinical drug review program, the commissioner shall consider the

following:

(a) whether the drug requires monitoring of prescribing protocols to

protect both the long-term efficacy of the drug and the public health;

(b) the potential for, or a history of, overuse, abuse, drug diversion

or illegal utilization; and

(c) the potential for, or a history of, utilization inconsistent with

approved indications. Where the commissioner finds that a drug meets at

least one of these criteria, in determining whether to make the drug

subject to prior authorization under the clinical drug review program,

the commissioner shall consider whether similarly effective alternatives

are available for the same disease state and the effect of that

availability or lack of availability.

4. The commissioner shall obtain an evaluation of the factors set

forth in subdivision three of this section and a recommendation as to

the establishment of a prior authorization requirement for a drug under

the clinical drug review program from the drug utilization review board.

For this purpose, the commissioner and the board, as applicable, shall

comply with the following meeting and notice processes established by

this article:

(a) the open meetings law and freedom of information law provisions of

subdivision six of section two hundred seventy-one of this article; and

(b) the public notice and interested party provisions of subdivisions

seven, eight and nine of section two hundred seventy-two of this

article.

5. The board shall recommend a procedure and criteria for the approval

of drugs subject to prior authorization under the clinical drug review

program. Such criteria shall include the specific approved clinical

indications for use of the drug.

6. The commissioner shall identify a drug for which prior

authorization is required, as well as the procedures and criteria for

approval of use of the drug, under the clinical drug review program

after considering the recommendations from the board and any comments

received from prescribers, dispensers, consumers and manufacturers of

the drug. In no event shall the prior authorization criteria for

approval pursuant to this subdivision result in denial of the prior

authorization request based on the relative cost of the drug subject to

prior authorization.

7. In the event that the patient does not meet the criteria for

approval established by the commissioner in subdivision six of this

section, the clinical drug review program shall provide a reasonable

opportunity for a prescriber to reasonably present his or her

justification for prior authorization. If, after consultation with the

program, the prescriber, in his or her reasonable professional judgment,

determines that the use of the prescription drug is warranted, the

prescriber's determination shall be final and prior authorization shall

be granted under this section; provided, however, that prior

authorization may be denied in cases where the department has

substantial evidence that the prescriber or patient is engaged in fraud

or abuse relating to the drug.

8. In the event that a patient presents a prescription to a pharmacist

for a prescription drug that requires prior authorization under this

section and for which prior authorization has not been obtained, the

pharmacist shall, within a prompt period based on professional judgment,

notify the prescriber. The prescriber shall, within a prompt period

based on professional judgment, either seek prior authorization or shall

contact the pharmacist and amend or cancel the prescription. The

pharmacist shall, within a prompt period based on professional judgment,

notify the patient when prior authorization has been obtained or denied

or when the prescription has been amended or cancelled.

9. In the instance where a prior authorization determination is not

completed within twenty-four hours of the original request solely as the

result of a failure of the program (whether by action or inaction),

prior authorization shall be immediately and automatically granted

without further action by the prescriber and the prescriber shall be

notified of this determination. In the instance where a prior

authorization determination is not completed within twenty-four hours of

the original request for any other reason, a seventy-two hour supply of

the medication will be approved by the program and the prescriber shall

be notified of the determination.

10. When, in the judgment of the prescriber or the pharmacist, an

emergency condition exists, and the prescriber or pharmacist notifies

the program to confirm that such an emergency condition exists, a

seventy-two hour emergency supply of the drug prescribed shall be

immediately authorized by the program.

11. The department or the panel shall monitor the prior authorization

process for prescribing patterns which are suspected of endangering the

health and safety of the patient or which demonstrate a likelihood of

fraud or abuse. The department or the panel shall take any and all

actions otherwise permitted by law to investigate such prescribing

patterns, to take remedial action and to enforce applicable federal and

state laws.

12. The commissioner may implement all or a portion of the clinical

drug review program through contracts with administrators with expertise

in management of pharmacy services, subject to applicable laws.

13. No prior authorization under the clinical drug review program

shall be required for any prescription under EPIC until the commissioner

has made prior authorization applicable to EPIC under section two

hundred seventy-five of this article.

14. For the period of eighteen months, commencing with the date of

enactment of this article, the commissioner is authorized to continue

prior authorization requirements for prescription drugs subject to prior

authorization as of one day prior to the enactment of this article and

which are not described in subdivision fourteen of section two hundred

seventy-two of this article. At the conclusion of the eighteen month

period, any such drug shall be subject to the clinical drug review

program requirements of this section; provided, however, that the

commissioner is authorized to immediately subject any such drug to prior

authorization without regard to the provisions of subdivisions three

through six of this section.