A02834 Summary:
BILL NO | A02834D |
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SAME AS | SAME AS S03419-C |
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SPONSOR | Titone |
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COSPNSR | Gottfried, 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 |
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MLTSPNSR | Buchwald, 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 |
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Amd §§3217-a, 4324, 4900, 4902 & 4903, Ins L; amd §§4408, 4900, 4902 & 4903, Pub Health L | |
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Relates to expedited utilization review of prescription drugs. |
A02834 Memo:
Go to topNEW 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.
A02834 Text:
Go to top 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. LBD03838-08-6A. 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 [forty42nine] 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 toA. 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.