A01174 Summary:

BILL NOA01174
 
SAME ASNo Same As
 
SPONSORRodriguez
 
COSPNSRAbinanti, Gunther, Bronson, Ramos, Cymbrowitz, Gottfried, Schimel, Arroyo, Jaffee, Perry, Weprin, Dinowitz, Rosenthal, Colton, Hooper, Zebrowski, Simanowitz, Magnarelli, Benedetto, Abbate, Aubry, Titone, Crespo, Quart, Cahill, Skoufis, Otis, Raia, Paulin, Montesano, Steck, Moya, Sepulveda
 
MLTSPNSRBrennan, Cook, Crouch, Duprey, Englebright, Giglio, Glick, Lavine, Lentol, Lifton, Lupardo, Magee, Peoples-Stokes, Rivera, Russell, Simon, Skartados, Thiele, Titus, Weinstein, Wright
 
Add 365-i, rpld 364-j subs 25 & 25-a, rpld & add 369-ee sub 2-b, Soc Serv L; amd 2511, 270 & 272, Pub Health L
 
Relates to prescription drugs in Medicaid managed care programs.
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A01174 Actions:

BILL NOA01174
 
01/08/2015referred to health
02/26/2015reported referred to codes
04/22/2015reported referred to ways and means
01/06/2016referred to health
01/21/2016reported referred to codes
04/05/2016reported referred to ways and means
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A01174 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A1174
 
SPONSOR: Rodriguez (MS)
  TITLE OF BILL: 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   PURPOSE OR GENERAL IDEA OF BILL: To restore the "prescriber prevails" principle for all drugs, and other basic consumer protections, to prescription drug coverage under Medicaid managed care and add it to Family Health Plus and Child Health Plus.   SUMMARY OF SPECIFIC PROVISIONS: This bill requires Medicaid managed care, Family Health Plus, and Child Health Plus plans to adopt the procedural protections of the Preferred Drug Program, including "pres- criber prevails," for all drugs. If a Medicaid managed care plan chooses not to do so, prescription drugs will be carved out of that plan and covered on a fee-for-service basis. Plans may also contract with the Department of Health to use the Department's PDP to carry out these functions.   JUSTIFICATION: In 2005, when Medicaid prescription drug coverage was administered directly, by Medicaid, rather than being contracted out to managed care plans, the Preferred Drug Program (PDP) was established to shift prescribing to "preferred" drugs: (a) drugs that are significantly better than others in their therapeutic class and (b) other drugs in the class whose manufacturers pay the state higher rebates, The PDP included a range of procedures to protect prescribers and patients, including the rule that if, after consulting with the program, a prescriber still insists on prescribing a "non-preferred" drug, the prescriber's judgment prevails and the prescription is approved. The PDP was quite effective at shifting prescribing to the preferred drugs, while also protecting prescriber judgments on behalf of their patients. It is a model of how to effectively organize health care. However, in 2011 the Legislature went along with the Governor's budget proposal to have Medicaid managed care plans take over the prescription drug benefit. "Prescriber prevails" was included only for atypical anti- psychotics and a small list of other drug classes. In the 2013-14 enacted budget, "prescriber prevails" was protected and expanded for some categories of drugs. This bill restores the "prescri- ber prevails" principle for all drugs and other basic consumer protections for prescription drug coverage under Medicaid managed care, and adds it to Family Health Plus and Child Health Plus.   PRIOR LEGISLATIVE HISTORY: A2335-C 2013-2014   FISCAL IMPLICATIONS: None.
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A01174 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          1174
 
                               2015-2016 Regular Sessions
 
                   IN ASSEMBLY
 
                                     January 8, 2015
                                       ___________
 
        Introduced  by  M.  of  A. RODRIGUEZ, ABINANTI, GUNTHER, BRONSON, RAMOS,
          CYMBROWITZ, BROOK-KRASNY, GOTTFRIED, SCHIMEL, ARROYO,  JAFFEE,  PERRY,
          SCARBOROUGH,  WEPRIN,  DINOWITZ, CAMARA, GOLDFEDER, ROSENTHAL, COLTON,
          HOOPER, ZEBROWSKI, SIMANOWITZ, MAGNARELLI, BENEDETTO,  ABBATE,  AUBRY,
          TITONE,  ROBERTS,  CRESPO, QUART, CAHILL, SKOUFIS, OTIS, RAIA, PAULIN,
          MONTESANO -- Multi-Sponsored by -- M. of A.    BRENNAN,  CLARK,  COOK,
          CROUCH,    DUPREY,    GLICK,    HEASTIE,   LENTOL,   LUPARDO,   MAGEE,
          PEOPLES-STOKES, RUSSELL, SKARTADOS, THIELE, TITUS,  WEINSTEIN,  WRIGHT
          -- 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, title eleven-D of article
     8  five of this chapter with respect to the family health plus program, and
     9  title one-A of article twenty-five of the public health law with respect
    10  to the child health insurance program.
    11    (b) "Clinical drug review program"  means  the  clinical  drug  review
    12  program under section two hundred seventy-four of the public health law.
    13    (c)  "Emergency  condition" means a medical or behavioral condition as
    14  determined by the prescriber  or  pharmacist,  the  onset  of  which  is
    15  sudden,  that  manifests  itself  by  symptoms  of  sufficient severity,
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00660-01-5

        A. 1174                             2
 
     1  including severe pain,  and  for  which  delay  in  beginning  treatment
     2  prescribed by the patient's health care practitioner would result in:
     3    (i)  placing  the  health  or safety of the person afflicted with such
     4  condition or other person or persons in serious jeopardy;
     5    (ii) serious impairment to such person's bodily functions;
     6    (iii) serious dysfunction of any bodily organ or part of such person;
     7    (iv) serious disfigurement of such person; or
     8    (v) severe discomfort.
     9    (d) "Managed care  provider"  means  a  managed  care  provider  under
    10  section  three  hundred  sixty-four-j of this title, a managed long term
    11  care plan or other care  coordination  model  under  section  forty-four
    12  hundred three-f of the public health law, a family health insurance plan
    13  under section three hundred sixty-nine-ee of this article (family health
    14  plus  program),  an  approved  organization under title one-A of article
    15  twenty-five of the public health law (child health  insurance  program),
    16  or  any  other  entity  that  provides  or arranges for the provision of
    17  medical assistance services and supplies  to  participants  directly  or
    18  indirectly (including by referral), including case management, including
    19  the managed care provider's authorized agents.
    20    (e) "Non-preferred drug" means a prescription drug that requires prior
    21  authorization under the participant's managed care provider.
    22    (f)  "Participant"  means a medical assistance recipient who receives,
    23  is required to receive or elects to receive his or her  medical  assist-
    24  ance services from a managed care provider.
    25    (g)  "Preferred drug" means a prescription drug that is not a non-pre-
    26  ferred drug under the patient's managed care provider.  "Preferred  drug
    27  list" means a list of a managed care provider's preferred drugs.
    28    (h)  "Preferred  drug program" means the preferred drug program estab-
    29  lished under section two hundred seventy-two of the public health law.
    30    (i) "Prescriber"  means  a  health  care  professional  authorized  to
    31  prescribe  prescription  drugs  for  a  participant  of the managed care
    32  provider, acting within his or her lawful scope of practice.
    33    (j) "Prescription drug" or "drug" means a drug defined in  subdivision
    34  seven of section sixty-eight hundred two of the education law, for which
    35  a  prescription  is  required  under the federal food, drug and cosmetic
    36  act. Any drug that does not require a prescription under such  act,  but
    37  which  would  otherwise be eligible for reimbursement under this article
    38  when ordered by a prescriber and the  prescription  is  subject  to  the
    39  applicable  provisions  of this article and paragraph (a) of subdivision
    40  four of section three hundred sixty-five-a of this title.
    41    (k) "Prior authorization" means a process requiring the prescriber  or
    42  the  dispenser  to  verify  with the participant's managed care provider
    43  that the drug is appropriate for the needs of the specific patient.
    44    (l) "Qualified prescription drug system" or "system" means  a  process
    45  under  this  section,  approved  by  the  commissioner,  through which a
    46  managed care provider approves payment for a non-preferred  drug  for  a
    47  participant based on prior authorization.
    48    2.  Payment  for  prescription drugs under capitation. (a) Payment for
    49  prescription drugs shall be included  in  the  capitation  payments  for
    50  services or supplies provided to a managed care provider's participants,
    51  provided  that  the  managed  care  provider pays for prescription drugs
    52  under a qualified prescription  drug  system.  Every  prescription  drug
    53  eligible  for reimbursement under this article prescribed in relation to
    54  a service provided by the  managed  care  provider  shall  be  either  a
    55  preferred  or  non-preferred  drug under the qualified prescription drug
    56  system.  The commissioner shall approve a managed care provider's quali-

        A. 1174                             3
 
     1  fied prescription drug system if it conforms to the provisions  of  this
     2  section.
     3    (b)  If  the managed care provider does not pay for prescription drugs
     4  under  a  qualified  prescription  drug   system,   then   payment   for
     5  prescription drugs for the managed care provider's patients shall not be
     6  included  in  such  capitation  payments and prescription drugs shall be
     7  provided  for  the  managed  care  provider's  participants  under   the
     8  preferred drug program.
     9    3.  Qualified  prescription  drug  system;  criteria.  (a) A qualified
    10  prescription drug system shall promote  access  to  the  most  effective
    11  prescription  drugs  while reducing the cost of prescription drugs under
    12  this article. This subdivision and  subdivision  four  of  this  section
    13  apply to qualified prescription drug systems.
    14    (b)  When  a  prescriber prescribes a non-preferred drug for a partic-
    15  ipant,  reimbursement  may  be  denied  unless  prior  authorization  is
    16  obtained,  unless no prior authorization is required under this section.
    17  When a prescriber prescribes a preferred  drug  for  a  participant,  no
    18  prior  authorization  shall  be required for reimbursement, unless prior
    19  authorization is required under the clinical drug review program.
    20    (c) The commissioner shall establish performance standards for systems
    21  that, at a minimum, ensure that  systems  provide  sufficient  technical
    22  support and timely responses to consumers, prescribers and pharmacists.
    23    (d)  The  commissioner shall adopt criteria for qualified prescription
    24  drug systems after considering  recommendations  and  comments  received
    25  from  prescribers,  pharmacists, participants, and organizations repres-
    26  enting them.
    27    (e) The managed care provider shall develop its  preferred  drug  list
    28  based  initially on an evaluation of the clinical effectiveness, safety,
    29  and patient outcomes, followed by consideration of  the  cost-effective-
    30  ness  of the drugs. In each therapeutic class, the managed care provider
    31  shall determine whether there is one drug  that  is  significantly  more
    32  clinically  effective  and  safe, and that drug shall be included on the
    33  preferred drug list without consideration of cost. If, among two or more
    34  drugs in a therapeutic class, the difference in  clinical  effectiveness
    35  and  safety  is  not clinically significant, then cost-effectiveness may
    36  also be considered in determining which drug or drugs shall be  included
    37  on the preferred drug list.
    38    4. Prior authorization. (a) A qualified prescription drug system shall
    39  make available a twenty-four hour per day, seven days per week telephone
    40  call  center  that  includes  a  tollfree  telephone  line and dedicated
    41  facsimile line to respond to requests for prior authorization. The  call
    42  center  shall  include  qualified health care professionals who shall be
    43  available to consult with prescribers concerning prescription drugs that
    44  are non-preferred drugs. A prescriber seeking prior authorization  shall
    45  consult  with  the  program  call  line to reasonably present his or her
    46  justification for the prescription  and  give  the  program's  qualified
    47  health care professional a reasonable opportunity to respond.
    48    (b)  When  a patient's health care provider prescribes a non-preferred
    49  drug, the prescriber shall consult with the system to  confirm  that  in
    50  his  or  her  reasonable  professional  judgment, the patient's clinical
    51  condition is consistent with the criteria for approval of  the  non-pre-
    52  ferred drug. Such criteria shall include:
    53    (i) the preferred drug has been tried by the patient and has failed to
    54  produce the desired health outcomes;
    55    (ii)  the  patient  has  tried  the preferred drug and has experienced
    56  unacceptable side effects;

        A. 1174                             4
 
     1    (iii) the patient has been stabilized  on  a  non-preferred  drug  and
     2  transition to the preferred drug would be medically contraindicated; or
     3    (iv)  other clinical indications identified by the commissioner or the
     4  managed care provider for the patient's use of the  non-preferred  drug,
     5  which  shall include consideration of the medical needs of special popu-
     6  lations, including children,  elderly,  chronically  ill,  persons  with
     7  mental  health conditions, and persons affected by HIV/AIDS or Hepatitis
     8  C.
     9    (c) In the event that the patient does not meet the criteria in  para-
    10  graph  (b)  of  this  subdivision, the prescriber may provide additional
    11  information to the managed care provider to justify the use  of  a  non-
    12  preferred  drug. The system shall provide a reasonable opportunity for a
    13  prescriber to reasonably present  his  or  her  justification  of  prior
    14  authorization.  If,  after  consultation with the managed care provider,
    15  the prescriber, in his or her reasonable professional  judgment,  deter-
    16  mines   that   the  use  of  a  non-preferred  drug  is  warranted,  the
    17  prescriber's determination shall be final.
    18    (d) If a prescriber meets the requirements of paragraph (b) or (c)  of
    19  this  subdivision,  the  prescriber shall be granted prior authorization
    20  under this section.
    21    (e) In the instance where a prior authorization determination  is  not
    22  completed  within  twenty-four  hours of the original request, solely as
    23  the result of a failure of the system (whether by action  or  inaction),
    24  prior  authorization shall be immediately and automatically granted with
    25  no further action by the prescriber and the prescriber shall be notified
    26  of this determination. In  the  instance  where  a  prior  authorization
    27  determination  is not completed within twenty-four hours of the original
    28  request for any other reason, a seventy-two hour supply of  the  medica-
    29  tion  shall  be approved by the system and the prescriber shall be noti-
    30  fied of this determination.
    31    (f) When, in the judgment of the  prescriber  or  the  pharmacist,  an
    32  emergency  condition  exists,  and the prescriber or pharmacist notifies
    33  the managed care provider that an emergency condition exists,  a  seven-
    34  ty-two hour emergency supply of the drug prescribed shall be immediately
    35  authorized by the managed care provider.
    36    (g)  In  the event that a patient presents a prescription to a pharma-
    37  cist for a prescription drug that is a non-preferred drug and for  which
    38  the  prescriber  has  not obtained a prior authorization, the pharmacist
    39  shall, within a prompt period based on professional judgment, notify the
    40  prescriber. The prescriber  shall,  within  a  prompt  period  based  on
    41  professional  judgment, either seek prior authorization or shall contact
    42  the pharmacist and amend or  cancel  the  prescription.  The  pharmacist
    43  shall, within a prompt period based on professional judgment, notify the
    44  patient when prior authorization has been obtained or denied or when the
    45  prescription has been amended or cancelled.
    46    (h)  Once prior authorization of a prescription for a drug that is not
    47  on the preferred drug list is obtained, prior authorization shall not be
    48  required for any refill of the prescription.
    49    (i) No prior authorization under a qualified prescription drug  system
    50  shall  be  required for: (i) atypical anti-psychotics; (ii) anti-depres-
    51  sants; (iii) anti-retrovirals used in the treatment of HIV/AIDS or Hepa-
    52  titis C; (iv) anti-rejection drugs used in the treatment  of  organ  and
    53  tissue  transplants;  and (v) any other therapeutic class for the treat-
    54  ment of mental illness, HIV/AIDS or Hepatitis C, approved by the commis-
    55  sioner.

        A. 1174                             5
 
     1    5. Clinical drug review program. In the case of a drug for which prior
     2  authorization is required under the clinical drug review program,  prior
     3  authorization  shall  be obtained under the clinical drug review program
     4  and not under this section.
     5    6.  Prescriber  conduct.  The managed care provider and the department
     6  shall  monitor  the  prior  authorization  process  under  a   qualified
     7  prescription drug system for prescribing patterns which are suspected of
     8  endangering  the health and safety of the patient or which demonstrate a
     9  likelihood of fraud or abuse. The managed care provider and the  depart-
    10  ment shall take any and all actions otherwise permitted by law to inves-
    11  tigate such prescribing patterns, to take remedial action and to enforce
    12  applicable federal and state laws.
    13    7. Use of preferred drug program. The commissioner may contract with a
    14  managed care provider for the provider to use the preferred drug program
    15  to  provide prior authorization under the managed care provider's quali-
    16  fied prescription drug system. The contract shall include terms required
    17  by the commissioner to maximize savings  to  the  Medicaid  program  and
    18  protect  the health and interests of the managed care provider's partic-
    19  ipants. The contract shall provide whether the  preferred  drug  program
    20  shall  use  the  managed care provider's lists of preferred and non-pre-
    21  ferred drugs or  the  preferred  drug  list  under  the  preferred  drug
    22  program, with respect to whether prior authorization is required.
    23    § 2. Subdivisions 25 and  25-a of section 364-j of the social services
    24  law are REPEALED.
    25    §  3.  Subdivision 2-b of section 369-ee of the social services law is
    26  REPEALED and a new subdivision 2-b is added to read as follows:
    27    2-b. Payment for prescription drugs. Payment  for  prescription  drugs
    28  shall  be  included  in  the capitated payments for services or supplies
    29  provided under a family health insurance plan or provided by an employer
    30  partnership for family health plus  plan  authorized  by  this  section,
    31  provided  that  the  plan  pays for prescription drugs under a qualified
    32  prescription drug system under section  three  hundred  sixty-five-i  of
    33  this  article.  Every prescription drug eligible for reimbursement under
    34  this article prescribed in relation to a service provided  by  the  plan
    35  shall  be  either  a preferred or non-preferred drug under the qualified
    36  prescription drug system. If the plan  does  not  pay  for  prescription
    37  drugs  under  a  qualified  prescription  drug  system, then payment for
    38  prescription drugs for the plan's patients shall not be included in such
    39  capitation payments and prescription drugs shall  be  provided  for  the
    40  approved organization's participants under the preferred drug program.
    41    §  4. Section 2511 of the public health law is amended by adding a new
    42  subdivision 22 to read as follows:
    43    22. Payment for prescription drugs.  Payment  for  prescription  drugs
    44  shall  be  included in the payments for services or supplies provided by
    45  the approved organization, provided that the plan pays for  prescription
    46  drugs  under  a  qualified  prescription drug system under section three
    47  hundred sixty-five-i of the social services law. Every prescription drug
    48  eligible for reimbursement under this article prescribed in relation  to
    49  a  service  provided  by  the  approved  organization  shall be either a
    50  preferred or non-preferred drug under the  qualified  prescription  drug
    51  system. If the approved organization does not pay for prescription drugs
    52  under   a   qualified   prescription   drug  system,  then  payment  for
    53  prescription drugs for the approved organization's patients shall not be
    54  included in such payments and prescription drugs shall be  provided  for
    55  the  approved  organization's  participants  under  the  preferred  drug
    56  program.

        A. 1174                             6
 
     1    § 5. Subdivision 11 of section  270  of  the  public  health  law,  as
     2  amended  by  section 2-a of part C of chapter 58 of the laws of 2008, is
     3  amended to read as follows:
     4    11.  "State  public  health plan" means the medical assistance program
     5  established by title eleven of article five of the social  services  law
     6  (referred  to in this article as "Medicaid"), the elderly pharmaceutical
     7  insurance coverage program established by title three of article two  of
     8  the  elder law (referred to in this article as "EPIC"), [and] the family
     9  health plus program established by section three  hundred  sixty-nine-ee
    10  of the social services law [to the extent that section provides that the
    11  program  shall  be subject to this article], and the child health insur-
    12  ance program under title one-A of article twenty-five of this chapter.
    13    § 6. Section 272 of the public health law is amended by adding  a  new
    14  subdivision 12 to read as follows:
    15    12.  No prior authorization shall be required under the preferred drug
    16  program for:
    17    (a) atypical anti-psychotics; (b) anti-depressants; (c)  anti-retrovi-
    18  rals  used  in the treatment of HIV/AIDS or Hepatitis C; (d) anti-rejec-
    19  tion drugs used in the treatment of organ and  tissue  transplants;  and
    20  (e)  any  other  therapeutic  class for the treatment of mental illness,
    21  HIV/AIDS or Hepatitis C, recommended by the board and  approved  by  the
    22  commissioner under this section.
    23    § 7. This act shall take effect on the one hundred eightieth day after
    24  it  shall  become a law; provided, however, that section two of this act
    25  shall take effect one year after  this  act  shall  become  a  law;  and
    26  provided  further,  that  the amendments to section 369-ee of the social
    27  services law made by section three of this  act  shall  not  affect  the
    28  repeal  of  such  section  and  shall  be  deemed repealed therewith and
    29  provided further, that the commissioner of health is immediately author-
    30  ized and directed to take actions necessary to implement this  act  when
    31  it takes effect.
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