§ 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.