A02834 Summary:

BILL NOA02834D
 
SAME ASSAME AS S03419-C
 
SPONSORTitone
 
COSPNSRGottfried, Rodriguez, Gunther, Zebrowski, Quart, Peoples-Stokes, Montesano, Cusick, Brindisi, Tedisco, Weprin, Rosenthal, Skoufis, Rozic, Johns, Jaffee, Stirpe, Steck, Otis, Abinanti, Barrett, Thiele, Pichardo, Kearns, Santabarbara, Colton, Crouch, Hunter, Paulin, Cook, Cymbrowitz, Joyner, Lavine, Castorina, Dilan, McDonald, Moya, Braunstein, Seawright, Raia, Woerner, Magnarelli, Blake, Solages, Walter, Lawrence, Simon, Harris
 
MLTSPNSRBuchwald, Ceretto, Crespo, Duprey, Englebright, Fahy, Friend, Galef, Glick, Hevesi, Hooper, Kolb, Lentol, Lupardo, Lupinacci, Markey, McDonough, McLaughlin, Murray, Oaks, Perry, Ra, Rivera, Schimel, Sepulveda, Tenney
 
Amd 3217-a, 4324, 4900, 4902 & 4903, Ins L; amd 4408, 4900, 4902 & 4903, Pub Health L
 
Relates to expedited utilization review of prescription drugs.
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A02834 Actions:

BILL NOA02834D
 
01/20/2015referred to insurance
05/07/2015amend (t) and recommit to insurance
05/07/2015print number 2834a
01/06/2016referred to insurance
02/29/2016amend and recommit to insurance
02/29/2016print number 2834b
05/27/2016amend (t) and recommit to insurance
05/27/2016print number 2834c
06/01/2016reported referred to rules
06/07/2016amend and recommit to rules 2834d
06/14/2016reported
06/14/2016rules report cal.266
06/14/2016substituted by s3419c
 S03419 AMEND=C YOUNG
 02/09/2015REFERRED TO INSURANCE
 05/06/2015AMEND (T) AND RECOMMIT TO INSURANCE
 05/06/2015PRINT NUMBER 3419A
 01/06/2016REFERRED TO INSURANCE
 03/16/2016AMEND AND RECOMMIT TO INSURANCE
 03/16/2016PRINT NUMBER 3419B
 06/07/2016AMEND (T) AND RECOMMIT TO INSURANCE
 06/07/2016PRINT NUMBER 3419C
 06/14/2016COMMITTEE DISCHARGED AND COMMITTED TO RULES
 06/14/2016ORDERED TO THIRD READING CAL.1675
 06/14/2016PASSED SENATE
 06/14/2016DELIVERED TO ASSEMBLY
 06/14/2016referred to insurance
 06/14/2016substituted for a2834d
 06/14/2016ordered to third reading rules cal.266
 06/16/2016passed assembly
 06/16/2016returned to senate
 12/20/2016DELIVERED TO GOVERNOR
 12/31/2016APPROVAL MEMO.30
 12/31/2016SIGNED CHAP.512
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A02834 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A2834D
 
SPONSOR: Titone (MS)
  TITLE OF BILL: An act to amend the insurance law and the public health law, in relation to expedited utilization review of prescription drugs   PURPOSE OR GENERAL IDEA OF BILL: The purpose of this bill is to regulate insurance companies, health maintenance organizations (HMOs), and utilization review agents who impose step therapy protocols on patients and to provide for an expe- dited appeals process for patients and their health care professionals to override such protocols.   SUMMARY OF SPECIFIC PROVISIONS: Sections 1 and 2 amend Section 3217-a (b)(10) and Section 4324 (b) (10) of the Insurance Law to require health insurance companies to provide patients and health care professionals with specific written information on their clinical review criteria relating to a decision made to utilize a step therapy protocol for a particular patient. Section 3 amends Section 4900 of the Insurance Law to define key terms such as "Step therapy protocol override determination" and "Step therapy protocol." Step therapy protocol means a policy, protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition are approved for a particular patient. Step therapy protocol override determination means a determination made by a utilization review agent to override a step therapy protocol. Section 4 amends Section 4902 (a) of the Insurance Law by adding a two new subdivisions (10) and (11). Subdivision 10 requires a utilization review agent to utilize evidenced-based and peer reviewed clinical review criteria that is appropriate for a patient's medical condition when establishing a step therapy protocol. Subdivision 11 requires a utilization review agent to utilize evidence-based and peer reviewed clinical review criteria that is appropriate to a particular patient and such patient's medical condition when making a determination about whether to override a step therapy protocol. Section 5 adds three new subsections (c-1), (c-2) and (c-3) to the Insurance Law to provide an expedited process for patients and health care providers to override a step therapy protocol. A determination must be made within 72 hours of the receipt of all information from the patient and/or health care provider in emergency cases. This section establishes standards for an override determination. Upon a determi- nation that the step therapy protocol should be overridden, the health plan must authorize immediate coverage for the prescription drug prescribed by the patient's treating health care provider. Section 6 amends Section 4903 (g) of the Insurance Law to provide that if an insurance company or utilization review agent fails to respond within the required timeframes, the appeal shall be deemed granted in favor of the patient. Sections 7, 8, 9, 10 and 11 make identical amendments as those described above to the Public Health Law to regulate step therapy or fail first protocols imposed by HMOs. Section 12 is an amendment of the Unconsolidated Laws to provide that the bill shall not be construed to prevent: a health care plan, utiliza- tion review agent, or pharmacy benefit manager from requiring a patient to try an AB-rated generic equivalent prior to providing coverage for the equivalent branded prescription drug; or a health care provider from prescribing a prescription drug that is determined to be medically appropriate. Section 13 provides for an effective date of January 1, 2017 applicable to health insurance and health benefit plans delivered, issued for delivery, or renewed after such date.   JUSTIFICATION: The Legislature makes the following findings: (1) Health insurance plans are increasingly making use of step therapy or "fail first" protocols under which patients are required to try one or more prescription drugs before coverage is provided for a drug selected by the patient's health care provider. (2) Step therapy protocols, where they are based on well-developed scientific standards and administered in a flexible manner that takes into account the individual needs of patients, can play an important role in controlling health care costs. (3) In some cases, requiring a patient to follow a step therapy protocol may have adverse and even dangerous consequences for the patient who may either not realize a benefit from taking a prescription drug or may suffer harm from taking an inappropriate drug. (4) Without uniform policies in the State for step therapy protocols, all patients may not receive the equivalent or most appropriate treat- ment. (5) It is imperative that step therapy protocols in the State preserve the health care provider's right to make treatment decisions in the best interests of the patient. (6) Therefore, it is a matter of public interest to require health insurance companies and utilization review organizations to base step therapy protocols on appropriate clinical practice guidelines or published peer review data developed by independent experts with know- ledge of the condition or conditions under consideration; that patients be exempt from step therapy protocols when inappropriate or otherwise not in the best interest of the patients; and that patients have access to a fair, transparent and independent process for requesting an excep- tion to a step therapy protocol when the patients' physician deems appropriate. The following states have enacted strong laws to prohibit or limit step therapy or fail first practices: Connecticut, Kentucky, Louisiana, Mary- land, Mississippi, Indiana and Washington. Patients in New York current- ly subject to step therapy or fail first practices require similar protections.   PRIOR LEGISLATIVE HISTORY: (2011-12) A.9397 Referred to Insurance (2013-14) A5124 Referred to Insurance   FISCAL IMPLICATIONS: Undetermined at this time.   EFFECTIVE DATE: The act would take effect on January 1, 2017 and apply to health insur- ance and health benefit plans delivered, issued for delivery, or renewed after such date.
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A02834 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         2834--D
 
                               2015-2016 Regular Sessions
 
                   IN ASSEMBLY
 
                                    January 20, 2015
                                       ___________
 
        Introduced by M. of A. TITONE, GOTTFRIED, RODRIGUEZ, GUNTHER, ZEBROWSKI,
          QUART,  PEOPLES-STOKES,  MONTESANO, CUSICK, BRINDISI, TEDISCO, WEPRIN,
          ROSENTHAL, SKOUFIS, ROZIC, JOHNS, JAFFEE, STIRPE, STECK, OTIS, ABINAN-
          TI, BARRETT, THIELE, PICHARDO, KEARNS, SANTABARBARA,  COLTON,  CROUCH,
          HUNTER,  PAULIN, COOK, CYMBROWITZ, JOYNER, GOLDFEDER, LAVINE, CASTORI-
          NA, DILAN,  McDONALD,  MOYA,  BRAUNSTEIN,  SEAWRIGHT,  RAIA,  WOERNER,
          MAGNARELLI,  BLAKE,  SOLAGES, WALTER -- Multi-Sponsored by -- M. of A.
          BUCHWALD, CERETTO, CRESPO, DUPREY, ENGLEBRIGHT, FAHY,  FRIEND,  GALEF,
          GLICK,  HEVESI,  KOLB, LENTOL, LUPARDO, LUPINACCI, McDONOUGH, McLAUGH-
          LIN, MURRAY, PERRY, RA, RIVERA, SCHIMEL,  SEPULVEDA,  TENNEY  --  read
          once   and  referred  to  the  Committee  on  Insurance  --  committee
          discharged, bill amended, ordered reprinted as amended and recommitted
          to said committee -- recommitted to  the  Committee  on  Insurance  in
          accordance  with Assembly Rule 3, sec. 2 -- committee discharged, bill
          amended, ordered reprinted as amended and recommitted to said  commit-
          tee  --  again  reported  from said committee with amendments, ordered
          reprinted as amended and recommitted to said committee -- reported and
          referred to the Committee on Rules -- Rules Committee discharged, bill
          amended, ordered reprinted as amended and recommitted to the Committee
          on Rules
 
        AN ACT to amend the insurance law and the public health law, in relation
          to expedited utilization review of prescription drugs
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1.  Paragraph  10  of subsection (b) of section 3217-a of the
     2  insurance law, as added by chapter 705 of the laws of 1996,  is  amended
     3  to read as follows:
     4    (10)  upon  written  request, provide specific written clinical review
     5  criteria relating to a particular condition or disease  including  clin-
     6  ical review criteria relating to a step therapy protocol override deter-
     7  mination  pursuant  to subsection (c-1), subsection (c-2) and subsection
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD03838-08-6

        A. 2834--D                          2
 
     1  (c-3) of section forty-nine hundred three of this  chapter,  and,  where
     2  appropriate, other clinical information which the insurer might consider
     3  in  its utilization review and the insurer may include with the informa-
     4  tion  a  description  of  how  it will be used in the utilization review
     5  process; provided, however, that  to  the  extent  such  information  is
     6  proprietary  to  the  insurer,  the insured or prospective insured shall
     7  only use the information for the purposes of assisting the  enrollee  or
     8  prospective  enrollee in evaluating the covered services provided by the
     9  organization. Such clinical review criteria, and other clinical informa-
    10  tion shall also be made available  to  a  health  care  professional  as
    11  defined in subsection (f) of section forty-nine hundred of this chapter,
    12  on behalf of an insured and upon written request;
    13    §  2.  Paragraph 10 of subsection (b) of section 4324 of the insurance
    14  law, as added by chapter 705 of the laws of 1996, is amended to read  as
    15  follows:
    16    (10)  upon  written  request, provide specific written clinical review
    17  criteria relating to a particular condition or disease  including  clin-
    18  ical review criteria relating to a step therapy protocol override deter-
    19  mination  pursuant  to subsection (c-1), subsection (c-2) and subsection
    20  (c-3) of section forty-nine hundred three of this  chapter,  and,  where
    21  appropriate,  other  clinical  information  which  the corporation might
    22  consider in its utilization review and the corporation may include  with
    23  the  information a description of how it will be used in the utilization
    24  review process; provided, however, that to the extent  such  information
    25  is  proprietary  to  the  corporation,  the  subscriber  or  prospective
    26  subscriber shall only use the information for the purposes of  assisting
    27  the  subscriber  or  prospective  subscriber  in  evaluating the covered
    28  services provided by the organization. Such  clinical  review  criteria,
    29  and  other clinical information shall also be made available to a health
    30  care professional as defined in subsection  (f)  of  section  forty-nine
    31  hundred  of  this  chapter,  on  behalf  of  an insured and upon written
    32  request;
    33    § 3. Section 4900 of the insurance law is amended by  adding  two  new
    34  subsections (g-8) and (g-9) to read as follows:
    35    (g-8)  "Step therapy protocol override determination" means a determi-
    36  nation made by a utilization review agent as defined in  subsection  (i)
    37  of  this  section  to  override  a  step  therapy  protocol  pursuant to
    38  subsections (c-1), (c-2) and (c-3) of section forty-nine  hundred  three
    39  of  this  title  granting  coverage  for  the health care professional's
    40  selected prescription drug or drugs. Any step therapy override  determi-
    41  nation  as defined by this subsection shall be eligible for appeal by an
    42  insured pursuant to this article.
    43    (g-9) "Step therapy protocol" means  a  policy,  protocol  or  program
    44  established  by  a utilization review agent as defined in subsection (i)
    45  of  this  section  that  establishes  the  specific  sequence  in  which
    46  prescription  drugs for a specified medical condition are approved for a
    47  particular insured.  Nothing in this chapter shall impair or prevent  an
    48  insured  from having the right to appeal pursuant to this article relat-
    49  ing to the imposition of a step therapy protocol.
    50    § 4. Subsection (a) of section 4902 of the insurance law is amended by
    51  adding two new paragraphs 10 and 11 to read as follows:
    52    10. When establishing a step therapy protocol,  a  utilization  review
    53  agent shall utilize recognized evidence-based and peer reviewed clinical
    54  review  criteria  that  also  takes  into  account the needs of atypical
    55  patient populations and diagnoses when establishing the clinical  review
    56  criteria.

        A. 2834--D                          3
 
     1    11.  When  conducting  utilization  review for a step therapy protocol
     2  override determination, a utilization review  agent  shall  utilize,  in
     3  addition   to   any  other  requirements  of  this  article,  recognized
     4  evidence-based and peer reviewed clinical review criteria that is appro-
     5  priate for the insured and the insured's medical condition.
     6    §  5. Section 4903 of the insurance law is amended by adding three new
     7  subsections (c-1), (c-2) and (c-3) to read as follows:
     8    (c-1) A utilization review agent shall grant a step  therapy  protocol
     9  override determination within seventy-two hours of the receipt of infor-
    10  mation  that  includes  supporting  rationale  and  documentation from a
    11  health care professional which demonstrates that:
    12    (1) The required prescription drug or drugs is contraindicated or will
    13  likely cause an adverse reaction by or physical or mental  harm  to  the
    14  insured;
    15    (2) The required prescription drug or drugs is expected to be ineffec-
    16  tive  based  on the known clinical history and conditions of the insured
    17  and the insured's prescription drug regimen;
    18    (3) The insured has tried the  required  prescription  drug  or  drugs
    19  while under their current or a previous health insurance or health bene-
    20  fit plan, or another prescription drug or drugs in the same pharmacolog-
    21  ic class or with the same mechanism of action and such prescription drug
    22  or  drugs  was  discontinued  due  to lack of efficacy or effectiveness,
    23  diminished effect, or an adverse event;
    24    (4) The insured is stable on a prescription drug or drugs selected  by
    25  their health care professional for the medical condition under consider-
    26  ation,  provided  that this shall not prevent a utilization review agent
    27  from requiring an insured to try an AB-rated generic equivalent prior to
    28  providing coverage for the equivalent brand name  prescription  drug  or
    29  drugs; or
    30    (5)  The required prescription drug or drugs is not in the best inter-
    31  est of the insured because it will likely cause a significant barrier to
    32  the insured's adherence to or compliance  with  the  insured's  plan  of
    33  care,  will  likely  worsen a comorbid condition of the insured, or will
    34  likely decrease the covered individual's ability to achieve or  maintain
    35  reasonable functional ability in performing daily activities.
    36    (c-2)  For  an insured with a medical condition that places the health
    37  of the insured in serious jeopardy  without  the  prescription  drug  or
    38  drugs  prescribed  by  the  insured's health care professional, the step
    39  therapy protocol override determination shall be granted within  twenty-
    40  four  hours  of  the  receipt  of  information  that includes supporting
    41  rationale and documentation from a health care professional  demonstrat-
    42  ing  one  or  more  of the standards provided for in subsection (c-1) of
    43  this section.
    44    (c-3) Upon a determination that the step therapy  protocol  should  be
    45  overridden,  the  health plan shall authorize immediate coverage for the
    46  prescription drug prescribed  by  the  insured's  treating  health  care
    47  professional.
    48    §  6. Subsection (g) of section 4903 of the insurance law, as added by
    49  chapter 586 of the laws of 1998, is amended to read as follows:
    50    (g) Failure by the utilization review agent to  make  a  determination
    51  within the time periods prescribed in this section shall be deemed to be
    52  an  adverse  determination  subject  to  appeal pursuant to section four
    53  thousand nine hundred four of this title, provided, however, that  fail-
    54  ure  to meet such time periods for a step therapy protocol as defined in
    55  subsection (g-9) of section forty-nine hundred of this title or  a  step
    56  therapy  protocol  override determination pursuant to subsections (c-1),

        A. 2834--D                          4
 
     1  (c-2) and (c-3) of this section shall be deemed to be an override of the
     2  step therapy protocol.
     3    §  7.  Paragraph  (j)  of  subdivision 2 of section 4408 of the public
     4  health law, as added by chapter 705 of the laws of 1996, is  amended  to
     5  read as follows:
     6    (j)  upon  written  request,  provide specific written clinical review
     7  criteria relating to a particular condition or disease  including  clin-
     8  ical review criteria relating to a step therapy protocol override deter-
     9  mination  pursuant  to  subdivisions  three-a,  three-b  and  three-c of
    10  section forty-nine hundred three of this chapter, and,  where  appropri-
    11  ate, other clinical information which the organization might consider in
    12  its  utilization review and the organization may include with the infor-
    13  mation a description of how it will be used in  the  utilization  review
    14  process;  provided,  however,  that  to  the  extent such information is
    15  proprietary to the organization, the enrollee  or  prospective  enrollee
    16  shall  only use the information for the purposes of assisting the enrol-
    17  lee or prospective enrollee in evaluating the covered services  provided
    18  by  the  organization. Such clinical review criteria, and other clinical
    19  information shall also be made available to a health  care  professional
    20  as  defined  in  subdivision  six  of section forty-nine hundred of this
    21  chapter, on behalf of an enrollee and upon written request;
    22    § 8. Section 4900 of the public health law is amended  by  adding  two
    23  new subdivisions 7-f-2 and 7-f-3 to read as follows:
    24    7-f-2. "Step therapy protocol override determination" means a determi-
    25  nation made by a utilization review agent as defined in subdivision nine
    26  of this section to override a step therapy protocol pursuant to subdivi-
    27  sions  three-a,  three-b and three-c of section forty-nine hundred three
    28  of this title granting  coverage  for  the  health  care  professional's
    29  selected  prescription drug or drugs. Any step therapy protocol override
    30  determination as defined by  this  subdivision  shall  be  eligible  for
    31  appeal by an enrollee pursuant to this article.
    32    7-f-3.  "Step  therapy  protocol"  means a policy, protocol or program
    33  established by a utilization review agent as defined in subdivision nine
    34  of  this  section  that  establishes  the  specific  sequence  in  which
    35  prescription  drugs for a specified medical condition are approved for a
    36  particular enrollee.  Nothing in this chapter shall impair or prevent an
    37  insured from having the right to appeal pursuant to this article  relat-
    38  ing to the imposition of a step therapy protocol.
    39    §  9.  Section  4902 of the public health law is amended by adding two
    40  new subdivisions 3 and 4 to read as follows:
    41    3. When establishing a step therapy  protocol,  a  utilization  review
    42  agent shall utilize recognized evidence-based and peer reviewed clinical
    43  review  criteria  that  takes into account the needs of atypical patient
    44  populations and diagnoses as well when establishing the clinical  review
    45  criteria.
    46    4.  When  conducting  utilization  review  for a step therapy protocol
    47  override determination, a utilization review  agent  shall  utilize,  in
    48  addition   to   any  other  requirements  of  this  article,  recognized
    49  evidence-based and peer reviewed clinical review criteria that is appro-
    50  priate for the enrollee and the enrollee's medical condition.
    51    § 10. Section 4903 of the public health law is amended by adding three
    52  new subdivisions 3-a, 3-b and 3-c to read as follows:
    53    3-a. A utilization review agent shall grant a  step  therapy  protocol
    54  override determination within seventy-two hours of the receipt of infor-
    55  mation  that  includes  supporting  rationale  and  documentation from a
    56  health care professional which demonstrates that:

        A. 2834--D                          5
 
     1    (a) The required prescription drug or drugs is  contraindicated,  will
     2  likely  cause  an  adverse reaction by or physical or mental harm to the
     3  enrollee;
     4    (b) The required prescription drug or drugs is expected to be ineffec-
     5  tive  based on the known clinical history and conditions of the enrollee
     6  and the enrollee's prescription drug regimen;
     7    (c) The enrollee has tried the required  prescription  drug  or  drugs
     8  while under their current or a previous health insurance or health bene-
     9  fit plan, or another prescription drug or drugs in the same pharmacolog-
    10  ic class or with the same mechanism of action and such prescription drug
    11  or  drugs  was  discontinued  due  to lack of efficacy or effectiveness,
    12  diminished effect, or an adverse event;
    13    (d) The enrollee is stable on a prescription drug or drugs selected by
    14  their health care professional for the medical condition under consider-
    15  ation, provided that this shall not prevent a utilization  review  agent
    16  from requiring an insured to try an AB-rated generic equivalent prior to
    17  providing  coverage  for  the equivalent brand name prescription drug or
    18  drugs; or
    19    (e) The required prescription drug or drugs is not in the best  inter-
    20  est  of  the enrollee because it will likely cause a significant barrier
    21  to the enrollee's adherence to or compliance with the enrollee's plan of
    22  care, will likely worsen a comorbid condition of the enrollee,  or  will
    23  likely  decrease  the  covered enrollee's ability to achieve or maintain
    24  reasonable functional ability in performing daily activities.
    25    3-b. For an enrollee with a medical condition that places  the  health
    26  of  the  insured  in  serious  jeopardy without the prescription drug or
    27  drugs prescribed by the insured's health  care  professional,  the  step
    28  therapy  protocol override determination shall be granted within twenty-
    29  four hours of  the  receipt  of  information  that  includes  supporting
    30  rationale  and documentation from a health care professional demonstrat-
    31  ing one or more of the standards provided for in subdivision three-a  of
    32  this section.
    33    3-c.  Upon  a  determination  that the step therapy protocol should be
    34  overridden, the health plan shall authorize immediate coverage  for  the
    35  prescription  drug or drugs prescribed by the enrollee's treating health
    36  care professional.
    37    § 11. Subdivision 7 of section 4903 of the public health law, as added
    38  by chapter 586 of the laws of 1998, is amended to read as follows:
    39    7. Failure by the utilization review agent  to  make  a  determination
    40  within the time periods prescribed in this section shall be deemed to be
    41  an  adverse  determination  subject to appeal pursuant to section [forty
    42  nine] forty-nine hundred four of this  title,  provided,  however,  that
    43  failure to meet such time periods for a step therapy protocol as defined
    44  in subdivision seven-f-three of section forty-nine hundred of this title
    45  or  a  step therapy protocol override determination pursuant to subdivi-
    46  sions three-a, three-b and three-c of this section shall be deemed to be
    47  an override of the step therapy protocol.
    48    § 12. This act shall not be construed to prevent: a health  care  plan
    49  or  utilization review agent from requiring a patient to try an AB-rated
    50  generic equivalent prior to providing coverage for the equivalent brand-
    51  ed prescription drug; or a  health  care  provider  from  prescribing  a
    52  prescription drug that is determined to be medically appropriate.
    53    §  13.  This act shall take effect on January 1, 2017, and shall apply
    54  only to health insurance and health benefit plans delivered, issued  for
    55  delivery,  or  renewed  after such date, provided further that effective
    56  immediately the superintendent of financial services  is  authorized  to

        A. 2834--D                          6
 
     1  promulgate such rules and regulations and take any other measures as may
     2  be necessary for the timely implementation of this act.
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