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.
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.
