Bill Text: NY S03419 | 2015-2016 | General Assembly | Amended
Bill Title: Relates to expedited utilization review of prescription drugs.
Spectrum: Slight Partisan Bill (Democrat 11-7)
Status: (Passed) 2016-12-31 - SIGNED CHAP.512 [S03419 Detail]
Download: New_York-2015-S03419-Amended.html
STATE OF NEW YORK ________________________________________________________________________ 3419--C 2015-2016 Regular Sessions IN SENATE February 9, 2015 ___________ Introduced by Sens. YOUNG, AKSHAR, AVELLA, BRESLIN, CARLUCCI, GOLDEN, KAMINSKY, LANZA, LARKIN, LATIMER, LAVALLE, MARCHIONE, PARKER, PERKINS, RIVERA, SAVINO, SQUADRON, VALESKY -- read twice and ordered printed, and when printed to be committed 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 Senate Rule 6, sec. 8 -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee 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 8 (c-3) of section forty-nine hundred three of this chapter, and, where 9 appropriate, other clinical information which the insurer might consider 10 in its utilization review and the insurer may include with the informa- 11 tion a description of how it will be used in the utilization review 12 process; provided, however, that to the extent such information is 13 proprietary to the insurer, the insured or prospective insured shall 14 only use the information for the purposes of assisting the enrollee or 15 prospective enrollee in evaluating the covered services provided by the 16 organization. Such clinical review criteria, and other clinical informa- 17 tion shall also be made available to a health care professional as EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD03838-09-6S. 3419--C 2 1 defined in subsection (f) of section forty-nine hundred of this chapter, 2 on behalf of an insured and upon written request; 3 § 2. Paragraph 10 of subsection (b) of section 4324 of the insurance 4 law, as added by chapter 705 of the laws of 1996, is amended to read as 5 follows: 6 (10) 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 subsection (c-1), subsection (c-2) and subsection 10 (c-3) of section forty-nine hundred three of this chapter, and, where 11 appropriate, other clinical information which the corporation might 12 consider in its utilization review and the corporation may include with 13 the information a description of how it will be used in the utilization 14 review process; provided, however, that to the extent such information 15 is proprietary to the corporation, the subscriber or prospective 16 subscriber shall only use the information for the purposes of assisting 17 the subscriber or prospective subscriber in evaluating the covered 18 services provided by the organization. Such clinical review criteria, 19 and other clinical information shall also be made available to a health 20 care professional as defined in subsection (f) of section forty-nine 21 hundred of this chapter, on behalf of an insured and upon written 22 request; 23 § 3. Section 4900 of the insurance law is amended by adding two new 24 subsections (g-8) and (g-9) to read as follows: 25 (g-8) "Step therapy protocol override determination" means a determi- 26 nation made by a utilization review agent as defined in subsection (i) 27 of this section to override a step therapy protocol pursuant to 28 subsections (c-1), (c-2) and (c-3) of section forty-nine hundred three 29 of this title granting coverage for the health care professional's 30 selected prescription drug or drugs. Any step therapy override determi- 31 nation as defined by this subsection shall be eligible for appeal by an 32 insured pursuant to this article. 33 (g-9) "Step therapy protocol" means a policy, protocol or program 34 established by a utilization review agent as defined in subsection (i) 35 of this section that establishes the specific sequence in which 36 prescription drugs for a specified medical condition are approved for a 37 particular insured. Nothing in this chapter shall impair or prevent an 38 insured from having the right to appeal pursuant to this article relat- 39 ing to the imposition of a step therapy protocol. 40 § 4. Subsection (a) of section 4902 of the insurance law is amended by 41 adding two new paragraphs 10 and 11 to read as follows: 42 10. When establishing a step therapy protocol, a utilization review 43 agent shall utilize recognized evidence-based and peer reviewed clinical 44 review criteria that also takes into account the needs of atypical 45 patient populations and diagnoses when establishing the clinical review 46 criteria. 47 11. When conducting utilization review for a step therapy protocol 48 override determination, a utilization review agent shall utilize, in 49 addition to any other requirements of this article, recognized 50 evidence-based and peer reviewed clinical review criteria that is appro- 51 priate for the insured and the insured's medical condition. 52 § 5. Section 4903 of the insurance law is amended by adding three new 53 subsections (c-1), (c-2) and (c-3) to read as follows: 54 (c-1) A utilization review agent shall grant a step therapy protocol 55 override determination within seventy-two hours of the receipt of infor-S. 3419--C 3 1 mation that includes supporting rationale and documentation from a 2 health care professional which demonstrates that: 3 (1) The required prescription drug or drugs is contraindicated or will 4 likely cause an adverse reaction by or physical or mental harm to the 5 insured; 6 (2) The required prescription drug or drugs is expected to be ineffec- 7 tive based on the known clinical history and conditions of the insured 8 and the insured's prescription drug regimen; 9 (3) The insured has tried the required prescription drug or drugs 10 while under their current or a previous health insurance or health bene- 11 fit plan, or another prescription drug or drugs in the same pharmacolog- 12 ic class or with the same mechanism of action and such prescription drug 13 or drugs was discontinued due to lack of efficacy or effectiveness, 14 diminished effect, or an adverse event; 15 (4) The insured is stable on a prescription drug or drugs selected by 16 their health care professional for the medical condition under consider- 17 ation, provided that this shall not prevent a utilization review agent 18 from requiring an insured to try an AB-rated generic equivalent prior to 19 providing coverage for the equivalent brand name prescription drug or 20 drugs; or 21 (5) The required prescription drug or drugs is not in the best inter- 22 est of the insured because it will likely cause a significant barrier to 23 the insured's adherence to or compliance with the insured's plan of 24 care, will likely worsen a comorbid condition of the insured, or will 25 likely decrease the covered individual's ability to achieve or maintain 26 reasonable functional ability in performing daily activities. 27 (c-2) For an insured with a medical condition that places the health 28 of the insured in serious jeopardy without the prescription drug or 29 drugs prescribed by the insured's health care professional, the step 30 therapy protocol override determination shall be granted within twenty- 31 four hours of the receipt of information that includes supporting 32 rationale and documentation from a health care professional demonstrat- 33 ing one or more of the standards provided for in subsection (c-1) of 34 this section. 35 (c-3) Upon a determination that the step therapy protocol should be 36 overridden, the health plan shall authorize immediate coverage for the 37 prescription drug prescribed by the insured's treating health care 38 professional. 39 § 6. Subsection (g) of section 4903 of the insurance law, as added by 40 chapter 586 of the laws of 1998, is amended to read as follows: 41 (g) Failure by the utilization review agent to make a determination 42 within the time periods prescribed in this section shall be deemed to be 43 an adverse determination subject to appeal pursuant to section four 44 thousand nine hundred four of this title, provided, however, that fail- 45 ure to meet such time periods for a step therapy protocol as defined in 46 subsection (g-9) of section forty-nine hundred of this title or a step 47 therapy protocol override determination pursuant to subsections (c-1), 48 (c-2) and (c-3) of this section shall be deemed to be an override of the 49 step therapy protocol. 50 § 7. Paragraph (j) of subdivision 2 of section 4408 of the public 51 health law, as added by chapter 705 of the laws of 1996, is amended to 52 read as follows: 53 (j) upon written request, provide specific written clinical review 54 criteria relating to a particular condition or disease including clin- 55 ical review criteria relating to a step therapy protocol override deter- 56 mination pursuant to subdivisions three-a, three-b and three-c ofS. 3419--C 4 1 section forty-nine hundred three of this chapter, and, where appropri- 2 ate, other clinical information which the organization might consider in 3 its utilization review and the organization may include with the infor- 4 mation 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 organization, the enrollee or prospective enrollee 7 shall only use the information for the purposes of assisting the enrol- 8 lee or prospective enrollee in evaluating the covered services provided 9 by the organization. Such clinical review criteria, and other clinical 10 information shall also be made available to a health care professional 11 as defined in subdivision six of section forty-nine hundred of this 12 chapter, on behalf of an enrollee and upon written request; 13 § 8. Section 4900 of the public health law is amended by adding two 14 new subdivisions 7-f-2 and 7-f-3 to read as follows: 15 7-f-2. "Step therapy protocol override determination" means a determi- 16 nation made by a utilization review agent as defined in subdivision nine 17 of this section to override a step therapy protocol pursuant to subdivi- 18 sions three-a, three-b and three-c of section forty-nine hundred three 19 of this title granting coverage for the health care professional's 20 selected prescription drug or drugs. Any step therapy protocol override 21 determination as defined by this subdivision shall be eligible for 22 appeal by an enrollee pursuant to this article. 23 7-f-3. "Step therapy protocol" means a policy, protocol or program 24 established by a utilization review agent as defined in subdivision nine 25 of this section that establishes the specific sequence in which 26 prescription drugs for a specified medical condition are approved for a 27 particular enrollee. Nothing in this chapter shall impair or prevent an 28 insured from having the right to appeal pursuant to this article relat- 29 ing to the imposition of a step therapy protocol. 30 § 9. Section 4902 of the public health law is amended by adding two 31 new subdivisions 3 and 4 to read as follows: 32 3. When establishing a step therapy protocol, a utilization review 33 agent shall utilize recognized evidence-based and peer reviewed clinical 34 review criteria that takes into account the needs of atypical patient 35 populations and diagnoses as well when establishing the clinical review 36 criteria. 37 4. When conducting utilization review for a step therapy protocol 38 override determination, a utilization review agent shall utilize, in 39 addition to any other requirements of this article, recognized 40 evidence-based and peer reviewed clinical review criteria that is appro- 41 priate for the enrollee and the enrollee's medical condition. 42 § 10. Section 4903 of the public health law is amended by adding three 43 new subdivisions 3-a, 3-b and 3-c to read as follows: 44 3-a. A utilization review agent shall grant a step therapy protocol 45 override determination within seventy-two hours of the receipt of infor- 46 mation that includes supporting rationale and documentation from a 47 health care professional which demonstrates that: 48 (a) The required prescription drug or drugs is contraindicated, will 49 likely cause an adverse reaction by or physical or mental harm to the 50 enrollee; 51 (b) The required prescription drug or drugs is expected to be ineffec- 52 tive based on the known clinical history and conditions of the enrollee 53 and the enrollee's prescription drug regimen; 54 (c) The enrollee has tried the required prescription drug or drugs 55 while under their current or a previous health insurance or health bene- 56 fit plan, or another prescription drug or drugs in the same pharmacolog-S. 3419--C 5 1 ic class or with the same mechanism of action and such prescription drug 2 or drugs was discontinued due to lack of efficacy or effectiveness, 3 diminished effect, or an adverse event; 4 (d) The enrollee is stable on a prescription drug or drugs selected by 5 their health care professional for the medical condition under consider- 6 ation, provided that this shall not prevent a utilization review agent 7 from requiring an insured to try an AB-rated generic equivalent prior to 8 providing coverage for the equivalent brand name prescription drug or 9 drugs; or 10 (e) The required prescription drug or drugs is not in the best inter- 11 est of the enrollee because it will likely cause a significant barrier 12 to the enrollee's adherence to or compliance with the enrollee's plan of 13 care, will likely worsen a comorbid condition of the enrollee, or will 14 likely decrease the covered enrollee's ability to achieve or maintain 15 reasonable functional ability in performing daily activities. 16 3-b. For an enrollee with a medical condition that places the health 17 of the insured in serious jeopardy without the prescription drug or 18 drugs prescribed by the insured's health care professional, the step 19 therapy protocol override determination shall be granted within twenty- 20 four hours of the receipt of information that includes supporting 21 rationale and documentation from a health care professional demonstrat- 22 ing one or more of the standards provided for in subdivision three-a of 23 this section. 24 3-c. Upon a determination that the step therapy protocol should be 25 overridden, the health plan shall authorize immediate coverage for the 26 prescription drug or drugs prescribed by the enrollee's treating health 27 care professional. 28 § 11. Subdivision 7 of section 4903 of the public health law, as added 29 by chapter 586 of the laws of 1998, is amended to read as follows: 30 7. Failure by the utilization review agent to make a determination 31 within the time periods prescribed in this section shall be deemed to be 32 an adverse determination subject to appeal pursuant to section [forty33nine] forty-nine hundred four of this title, provided, however, that 34 failure to meet such time periods for a step therapy protocol as defined 35 in subdivision seven-f-three of section forty-nine hundred of this title 36 or a step therapy protocol override determination pursuant to subdivi- 37 sions three-a, three-b and three-c of this section shall be deemed to be 38 an override of the step therapy protocol. 39 § 12. This act shall not be construed to prevent: a health care plan 40 or utilization review agent from requiring a patient to try an AB-rated 41 generic equivalent prior to providing coverage for the equivalent brand- 42 ed prescription drug; or a health care provider from prescribing a 43 prescription drug that is determined to be medically appropriate. 44 § 13. This act shall take effect on January 1, 2017, and shall apply 45 only to health insurance and health benefit plans delivered, issued for 46 delivery, or renewed after such date, provided further that effective 47 immediately the superintendent of financial services is authorized to 48 promulgate such rules and regulations and take any other measures as may 49 be necessary for the timely implementation of this act.
