Add §365-i, rpld §364-j subs 25 & 25-a, Soc Serv L; amd §§2511, 270 & 272, Pub Health L
Requires Medicaid managed care, and Child Health Plus plans to adopt the procedural protections of the Preferred Drug Program, including "prescriber prevails," for all drugs.
STATE OF NEW YORK
________________________________________________________________________
2843
2019-2020 Regular Sessions
IN ASSEMBLY
January 25, 2019
___________
Introduced by M. of A. RODRIGUEZ, ARROYO, AUBRY, ABBATE, BENEDETTO,
JAFFEE, ABINANTI, RAIA, MAGNARELLI, PERRY, PAULIN, PEOPLES-STOKES,
GOTTFRIED -- Multi-Sponsored by -- M. of A. GIGLIO, GLICK, LAVINE,
LENTOL, LIFTON, LUPARDO, SIMON, THIELE -- read once and referred to
the Committee on Health
AN ACT to amend the social services law and the public health law, in
relation to prescription drugs in Medicaid managed care programs; and
to repeal certain provisions of the social services law, relating to
payments for prescription drugs
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The social services law is amended by adding a new section
2 365-i to read as follows:
3 § 365-i. Prescription drugs in Medicaid managed care programs. 1.
4 Definitions. As used in this section, unless the context clearly
5 requires otherwise:
6 (a) "Article" means title eleven of article five of this chapter with
7 respect to the medical assistance program, and title one-A of article
8 twenty-five of the public health law with respect to the child health
9 insurance plan.
10 (b) "Clinical drug review program" means the clinical drug review
11 program under section two hundred seventy-four of the public health law.
12 (c) "Emergency condition" means a medical or behavioral condition as
13 determined by the prescriber or pharmacist, the onset of which is
14 sudden, that manifests itself by symptoms of sufficient severity,
15 including severe pain, and for which delay in beginning treatment
16 prescribed by the patient's health care practitioner would result in:
17 (i) placing the health or safety of the person afflicted with such
18 condition or other person or persons in serious jeopardy;
19 (ii) serious impairment to such person's bodily functions;
20 (iii) serious dysfunction of any bodily organ or part of such person;
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD06484-02-9
A. 2843 2
1 (iv) serious disfigurement of such person; or
2 (v) severe discomfort.
3 (d) "Managed care provider" means a managed care provider under
4 section three hundred sixty-four-j of this title, a managed long term
5 care plan or other care coordination model under section forty-four
6 hundred three-f of the public health law, an approved organization under
7 title one-A of article twenty-five of the public health law (child
8 health insurance plan), or any other entity that provides or arranges
9 for the provision of medical assistance services and supplies to partic-
10 ipants directly or indirectly (including by referral), including case
11 management, including the managed care provider's authorized agents.
12 (e) "Non-preferred drug" means a prescription drug that requires prior
13 authorization under the participant's managed care provider.
14 (f) "Participant" means a medical assistance recipient who receives,
15 is required to receive or elects to receive his or her medical assist-
16 ance services from a managed care provider.
17 (g) "Preferred drug" means a prescription drug that is not a non-pre-
18 ferred drug under the patient's managed care provider. "Preferred drug
19 list" means a list of a managed care provider's preferred drugs.
20 (h) "Preferred drug program" means the preferred drug program estab-
21 lished under section two hundred seventy-two of the public health law.
22 (i) "Prescriber" means a health care professional authorized to
23 prescribe prescription drugs for a participant of the managed care
24 provider, acting within his or her lawful scope of practice.
25 (j) "Prescription drug" or "drug" means a drug defined in subdivision
26 seven of section sixty-eight hundred two of the education law, for which
27 a prescription is required under the federal food, drug and cosmetic
28 act. Any drug that does not require a prescription under such act, but
29 which would otherwise be eligible for reimbursement under this article
30 when ordered by a prescriber and the prescription is subject to the
31 applicable provisions of this article and paragraph (a) of subdivision
32 four of section three hundred sixty-five-a of this title.
33 (k) "Prior authorization" means a process requiring the prescriber or
34 the dispenser to verify with the participant's managed care provider
35 that the drug is appropriate for the needs of the specific patient.
36 (l) "Qualified prescription drug system" or "system" means a process
37 under this section, approved by the commissioner, through which a
38 managed care provider approves payment for a non-preferred drug for a
39 participant based on prior authorization.
40 2. Payment for prescription drugs under capitation. (a) Payment for
41 prescription drugs shall be included in the capitation payments for
42 services or supplies provided to a managed care provider's participants,
43 provided that the managed care provider pays for prescription drugs
44 under a qualified prescription drug system. Every prescription drug
45 eligible for reimbursement under this article prescribed in relation to
46 a service provided by the managed care provider shall be either a
47 preferred or non-preferred drug under the qualified prescription drug
48 system. The commissioner shall approve a managed care provider's quali-
49 fied prescription drug system if it conforms to the provisions of this
50 section.
51 (b) If the managed care provider does not pay for prescription drugs
52 under a qualified prescription drug system, then payment for
53 prescription drugs for the managed care provider's patients shall not be
54 included in such capitation payments and prescription drugs shall be
55 provided for the managed care provider's participants under the
56 preferred drug program.
A. 2843 3
1 3. Qualified prescription drug system; criteria. (a) A qualified
2 prescription drug system shall promote access to the most effective
3 prescription drugs while reducing the cost of prescription drugs under
4 this article. This subdivision and subdivision four of this section
5 apply to qualified prescription drug systems.
6 (b) When a prescriber prescribes a non-preferred drug for a partic-
7 ipant, reimbursement may be denied unless prior authorization is
8 obtained, unless no prior authorization is required under this section.
9 When a prescriber prescribes a preferred drug for a participant, no
10 prior authorization shall be required for reimbursement, unless prior
11 authorization is required under the clinical drug review program.
12 (c) The commissioner shall establish performance standards for systems
13 that, at a minimum, ensure that systems provide sufficient technical
14 support and timely responses to consumers, prescribers and pharmacists.
15 (d) The commissioner shall adopt criteria for qualified prescription
16 drug systems after considering recommendations and comments received
17 from prescribers, pharmacists, participants, and organizations repres-
18 enting them.
19 (e) The managed care provider shall develop its preferred drug list
20 based initially on an evaluation of the clinical effectiveness, safety,
21 and patient outcomes, followed by consideration of the cost-effective-
22 ness of the drugs. In each therapeutic class, the managed care provider
23 shall determine whether there is one drug that is significantly more
24 clinically effective and safe, and that drug shall be included on the
25 preferred drug list without consideration of cost. If, among two or more
26 drugs in a therapeutic class, the difference in clinical effectiveness
27 and safety is not clinically significant, then cost-effectiveness may
28 also be considered in determining which drug or drugs shall be included
29 on the preferred drug list.
30 4. Prior authorization. (a) A qualified prescription drug system shall
31 make available a twenty-four hour per day, seven days per week telephone
32 call center that includes a tollfree telephone line and dedicated
33 facsimile line to respond to requests for prior authorization. The call
34 center shall include qualified health care professionals who shall be
35 available to consult with prescribers concerning prescription drugs that
36 are non-preferred drugs. A prescriber seeking prior authorization shall
37 consult with the program call line to reasonably present his or her
38 justification for the prescription and give the program's qualified
39 health care professional a reasonable opportunity to respond.
40 (b) When a patient's health care provider prescribes a non-preferred
41 drug, the prescriber shall consult with the system to confirm that in
42 his or her reasonable professional judgment, the patient's clinical
43 condition is consistent with the criteria for approval of the non-pre-
44 ferred drug. Such criteria shall include:
45 (i) the preferred drug has been tried by the patient and has failed to
46 produce the desired health outcomes;
47 (ii) the patient has tried the preferred drug and has experienced
48 unacceptable side effects;
49 (iii) the patient has been stabilized on a non-preferred drug and
50 transition to the preferred drug would be medically contraindicated; or
51 (iv) other clinical indications identified by the commissioner or the
52 managed care provider for the patient's use of the non-preferred drug,
53 which shall include consideration of the medical needs of special popu-
54 lations, including children, elderly, chronically ill, persons with
55 mental health conditions, and persons affected by HIV/AIDS or Hepatitis
56 C.
A. 2843 4
1 (c) In the event that the patient does not meet the criteria in para-
2 graph (b) of this subdivision, the prescriber may provide additional
3 information to the managed care provider to justify the use of a non-
4 preferred drug. The system shall provide a reasonable opportunity for a
5 prescriber to reasonably present his or her justification of prior
6 authorization. If, after consultation with the managed care provider,
7 the prescriber, in his or her reasonable professional judgment, deter-
8 mines that the use of a non-preferred drug is warranted, the
9 prescriber's determination shall be final.
10 (d) If a prescriber meets the requirements of paragraph (b) or (c) of
11 this subdivision, the prescriber shall be granted prior authorization
12 under this section.
13 (e) In the instance where a prior authorization determination is not
14 completed within twenty-four hours of the original request, solely as
15 the result of a failure of the system (whether by action or inaction),
16 prior authorization shall be immediately and automatically granted with
17 no further action by the prescriber and the prescriber shall be notified
18 of this determination. In the instance where a prior authorization
19 determination is not completed within twenty-four hours of the original
20 request for any other reason, a seventy-two hour supply of the medica-
21 tion shall be approved by the system and the prescriber shall be noti-
22 fied of this determination.
23 (f) When, in the judgment of the prescriber or the pharmacist, an
24 emergency condition exists, and the prescriber or pharmacist notifies
25 the managed care provider that an emergency condition exists, a seven-
26 ty-two hour emergency supply of the drug prescribed shall be immediately
27 authorized by the managed care provider.
28 (g) In the event that a patient presents a prescription to a pharma-
29 cist for a prescription drug that is a non-preferred drug and for which
30 the prescriber has not obtained a prior authorization, the pharmacist
31 shall, within a prompt period based on professional judgment, notify the
32 prescriber. The prescriber shall, within a prompt period based on
33 professional judgment, either seek prior authorization or shall contact
34 the pharmacist and amend or cancel the prescription. The pharmacist
35 shall, within a prompt period based on professional judgment, notify the
36 patient when prior authorization has been obtained or denied or when the
37 prescription has been amended or cancelled.
38 (h) Once prior authorization of a prescription for a drug that is not
39 on the preferred drug list is obtained, prior authorization shall not be
40 required for any refill of the prescription.
41 (i) No prior authorization under a qualified prescription drug system
42 shall be required for: (i) atypical anti-psychotics; (ii) anti-depres-
43 sants; (iii) anti-retrovirals used in the treatment of HIV/AIDS or Hepa-
44 titis C; (iv) anti-rejection drugs used in the treatment of organ and
45 tissue transplants; and (v) any other therapeutic class for the treat-
46 ment of mental illness, HIV/AIDS or Hepatitis C, approved by the commis-
47 sioner.
48 5. Clinical drug review program. In the case of a drug for which prior
49 authorization is required under the clinical drug review program, prior
50 authorization shall be obtained under the clinical drug review program
51 and not under this section.
52 6. Prescriber conduct. The managed care provider and the department
53 shall monitor the prior authorization process under a qualified
54 prescription drug system for prescribing patterns which are suspected of
55 endangering the health and safety of the patient or which demonstrate a
56 likelihood of fraud or abuse. The managed care provider and the depart-
A. 2843 5
1 ment shall take any and all actions otherwise permitted by law to inves-
2 tigate such prescribing patterns, to take remedial action and to enforce
3 applicable federal and state laws.
4 7. Use of preferred drug program. The commissioner may contract with a
5 managed care provider for the provider to use the preferred drug program
6 to provide prior authorization under the managed care provider's quali-
7 fied prescription drug system. The contract shall include terms required
8 by the commissioner to maximize savings to the Medicaid program and
9 protect the health and interests of the managed care provider's partic-
10 ipants. The contract shall provide whether the preferred drug program
11 shall use the managed care provider's lists of preferred and non-pre-
12 ferred drugs or the preferred drug list under the preferred drug
13 program, with respect to whether prior authorization is required.
14 § 2. Subdivisions 25 and 25-a of section 364-j of the social services
15 law are REPEALED.
16 § 3. Section 2511 of the public health law is amended by adding a new
17 subdivision 22 to read as follows:
18 22. Payment for prescription drugs. Payment for prescription drugs
19 shall be included in the payments for services or supplies provided by
20 the approved organization, provided that the plan pays for prescription
21 drugs under a qualified prescription drug system under section three
22 hundred sixty-five-i of the social services law. Every prescription drug
23 eligible for reimbursement under this article prescribed in relation to
24 a service provided by the approved organization shall be either a
25 preferred or non-preferred drug under the qualified prescription drug
26 system. If the approved organization does not pay for prescription drugs
27 under a qualified prescription drug system, then payment for
28 prescription drugs for the approved organization's patients shall not be
29 included in such payments and prescription drugs shall be provided for
30 the approved organization's participants under the preferred drug
31 program.
32 § 4. Subdivision 11 of section 270 of the public health law, as
33 amended by section 2-a of part C of chapter 58 of the laws of 2008, is
34 amended to read as follows:
35 11. "State public health plan" means the medical assistance program
36 established by title eleven of article five of the social services law
37 (referred to in this article as "Medicaid"), the elderly pharmaceutical
38 insurance coverage program established by title three of article two of
39 the elder law (referred to in this article as "EPIC"), [and the family
40 health plus program established by section three hundred sixty-nine-ee
41 of the social services law to the extent that section provides that the
42 program shall be subject to this article], and the child health insur-
43 ance plan under title one-A of article twenty-five of this chapter.
44 § 5. Section 272 of the public health law is amended by adding a new
45 subdivision 12 to read as follows:
46 12. No prior authorization shall be required under the preferred drug
47 program for:
48 (a) atypical anti-psychotics; (b) anti-depressants; (c) anti-retrovi-
49 rals used in the treatment of HIV/AIDS or Hepatitis C; (d) anti-rejec-
50 tion drugs used in the treatment of organ and tissue transplants; and
51 (e) any other therapeutic class for the treatment of mental illness,
52 HIV/AIDS or Hepatitis C, recommended by the board and approved by the
53 commissioner under this section.
54 § 6. This act shall take effect on the one hundred eightieth day after
55 it shall become a law; provided, however, that section two of this act
56 shall take effect one year after this act shall become a law; and
A. 2843 6
1 provided further, that the commissioner of health is immediately author-
2 ized and directed to take actions necessary to implement this act when
3 it takes effect.
