STATE OF NEW YORK
________________________________________________________________________
8237--C
2011-2012 Regular Sessions
IN ASSEMBLY
June 8, 2011
___________
Introduced by M. of A. P. RIVERA, CASTRO, CYMBROWITZ, CRESPO, SCARBOR-
OUGH, N. RIVERA, JAFFEE, GIBSON, MOYA, HIKIND, ARROYO, J. RIVERA,
RODRIGUEZ, LINARES, STEVENSON, RAMOS, ROSENTHAL, ABINANTI, PERRY,
MILLMAN, GUNTHER, BURLING, HOOPER, WEISENBERG, SCHIMEL -- Multi-Spon-
sored by -- M. of A. COOK, GLICK, HEASTIE, V. LOPEZ, McDONOUGH, SWEE-
NEY, TITONE -- read once and referred to the Committee on Health --
committee discharged, bill amended, ordered reprinted as amended and
recommitted to said committee -- again reported from said committee
with amendments, ordered reprinted as amended and recommitted to said
committee -- recommitted to the Committee on Health in accordance with
Assembly Rule 3, sec. 2 -- committee discharged, bill amended, ordered
reprinted as amended and recommitted to said committee
AN ACT to amend the social services law, in relation to requiring
managed care providers to provide coverage of medically necessary
prescription drugs and medical supplies
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Subdivision 1 of section 364-j of the social services law
2 is amended by adding a new paragraph (z) to read as follows:
3 (z) "Pharmacy and therapeutics committee". An independent committee
4 used by a managed care provider to develop and manage a formulary or
5 preferred drug list that operates pursuant to the requirements of subdi-
6 vision twenty-six of this section.
7 § 2. Section 364-j of the social services law is amended by adding two
8 new subdivisions 26 and 27 to read as follows:
9 26. Notwithstanding any other provision of law to the contrary,
10 managed care providers shall cover medically necessary prescription
11 drugs and medical supplies in accordance with the following require-
12 ments:
13 (a) A managed care provider may utilize a formulary or preferred drug
14 list in the administration of this benefit provided that such formulary
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD11505-11-2
A. 8237--C 2
1 shall have been reviewed and approved by an independent pharmacy and
2 therapeutics committee comprised of members from various clinical
3 specialties that adequately represent the needs of enrollees including,
4 at a minimum, the following categories of members:
5 (i) New York state licensed, board certified physician practicing in
6 the community and serving the Medicaid population;
7 (ii) New York state licensed, board certified specialty physicians,
8 including, at a minimum:
9 (A) Physician who is board certified in cardiology, and
10 (B) Physician who is board certified in psychiatry;
11 (iii) New York state licensed pharmacist practicing in the community;
12 and
13 (iv) at least on a consulting basis, an adequate number of high volume
14 specialists, including, but not limited to, an HIV specialist, defined
15 as a physician that has met the criteria of:
16 (A) The HIV Medicine Association (HIVMA) definition of an HIV-experi-
17 enced provider, or
18 (B) HIV Specialist status accorded by the American Academy of HIV
19 Medicine (AAHIVM).
20 (b) The department of health shall develop standards to ensure that
21 each managed care provider's pharmacy and therapeutics committee members
22 come from various clinical specialties and adequately represent the
23 needs of plan beneficiaries. A majority of members shall be practicing
24 physicians or practicing pharmacists licensed pursuant to title eight of
25 the education law. Such department shall also develop standards to
26 ensure a transparent process for formulary development which shall
27 include the opportunity for public comment prior to any changes to the
28 formulary. Each managed care provider's committee shall meet no less
29 frequently than on a quarterly basis and shall meet the following
30 requirements:
31 (i) minutes of the meetings shall be made available to the public and
32 on the appropriate state internet website within ten business days after
33 such minutes are approved;
34 (ii) not less than thirty days prior to a meeting the pharmacy and
35 therapeutics committee shall post to the appropriate state internet
36 website (A) the meeting agenda, (B) a list of the drug classes to be
37 considered at the meeting, and (C) background materials and supporting
38 documentation provided to the members of such committee with respect to
39 drugs and drug classes that are before the committee for review; and
40 (iii) the pharmacy and therapeutics committee shall provide appropri-
41 ate opportunity for public testimony at each regularly scheduled commit-
42 tee meeting. Prior to deliberating on any recommendations regarding a
43 drug or a class of drugs, the committee shall accept testimony, in writ-
44 ing or in person, that is offered by a manufacturer of such drugs or
45 another interested party.
46 (c) A managed care provider that adopts a formulary shall cover
47 prescription drugs in all categories and classes for all disease states
48 and provide a broad range of therapeutic options for all USP model
49 guidelines for formulary key drug types and designated drug classes,
50 including all or substantially all drugs in the antidepressant, atypical
51 antipsychotic, antineoplastic, anticonvulsant, immunosuppressant and
52 anti-retroviral classes. A managed care provider shall also cover a
53 prescription drug when the pharmacy and therapeutics committee deter-
54 mines a drug is significantly more clinically effective or safe than
55 other drugs in the class.
A. 8237--C 3
1 (d) A managed care provider shall provide coverage for non-
2 preferred/non-formulary prescription drugs that were prescribed to the
3 participant to treat a condition that is treated on an ongoing basis,
4 either with continuous medication or a medication taken as needed prior
5 to prescription drugs being added to the managed care program or being
6 removed from the formulary.
7 (e) The prior authorization shall be processed, and a response sent to
8 the requesting pharmacist within two business days of submission. Prior
9 to the completion of the prior authorization process, a plan shall cover
10 a minimum seventy-two hour supply of the prescribed drug and the pharma-
11 cist shall be reimbursed for dispensing a seventy-two hour supply to an
12 enrollee.
13 (f) A managed care provider shall only implement reasonable and gener-
14 ally acceptable formulary and utilization management including, but not
15 limited to, prior authorization, step therapy and generic substitutions;
16 provided such tools are reviewed and approved by the pharmacy and thera-
17 peutics committee based on the strength of scientific evidence, stand-
18 ards of practice and nationally accepted treatment guidelines.
19 (g) Prior to removing a covered drug from its formulary, a managed
20 care provider must provide at least sixty days notice to enrollees,
21 authorized prescribers, network pharmacies and pharmacists prior to the
22 date such change becomes effective.
23 (h) A managed care provider shall review, through the pharmacy and
24 therapeutics committee, all drugs that receive approval from the federal
25 Food and Drug Administration within ninety days of their release in the
26 market, and decisions regarding inclusion in any formulary or preferred
27 drug list shall be made within one hundred eighty days of their release
28 in the market. Provided, however, that in the case of those drugs which
29 have received priority expedited review and approval of the Food and
30 Drug Administration, a decision for inclusion in the formulary or
31 preferred drug list shall be made within ninety days of such approval by
32 the Food and Drug Administration.
33 (i) A managed care provider shall be subject to and shall use the
34 grievance and appeals process, including the right to external review,
35 mandated by article forty-nine of the public health law and title 42 of
36 the Code of Federal Regulations, Part 438, upon receipt of an appeal of
37 a denial of a requested prescription drug, including a denial based on
38 step therapy or fail first protocols.
39 (j) On or before April first, two thousand thirteen, the department of
40 health shall develop standardized drug prior authorization request forms
41 to be utilized by healthcare providers, and accepted by managed care
42 organizations contracted by the state. To the extent electronic
43 prescribing systems are used, electronic prior authorization capabili-
44 ties shall be incorporated into the program.
45 27. The department of health shall prepare a report no later than
46 eighteen months after the implementation of any expansion of managed
47 care to a new population and/or for new benefits or services. The
48 department shall post a draft report on its website and provide an
49 opportunity for public comment. The final report shall be submitted to
50 the governor and the legislature, along with a description of the proc-
51 ess provided for public input. The report shall include an assessment of
52 the following:
53 (a) the impact of managed care on patient access to care, including an
54 evaluation of any barriers to use of services, including prescription
55 drugs, created by the use of medical management or cost containment
56 tools;
A. 8237--C 4
1 (b) the impact of the managed care expansion on utilization of
2 services, quality of care and patient outcomes; and
3 (c) the use of prior authorization and other utilization management
4 tools, including an assessment of whether these tools pose an undue
5 administrative burden for physicians and/or create barriers to needed
6 care.
7 § 3. This act shall take effect immediately; provided, however, that
8 the amendments to section 364-j of the social services law made by
9 sections one and two of this act shall not affect the repeal of such
10 section and shall be deemed repealed therewith.
