CS/HB 185 STEP THERAPY GUIDELINES

Rep Elizabeth "Liz" Thomson

Actions: [2] not prntd-HRC [3] w/drn-prntd-ref- HHHC/HJC-HHHC [7] DNP-CS/DP-HJC

Scheduled: Not Scheduled

 HB185 provides new guidlines for step therapy relates to pharmaceutical perscriptions provided by health plans and Medicaid.  

 Synopsis: HB185 relates to health coverage by enacting new sections of the Health Care Purchasing Act, The Public Assistance Act, The New Mexico Insurance Code, The Health Maintenance Organization Law and the Nonprofit Health Care Plan Law to establish guidelines relating to step therapy for prescription drug coverage and eliminate step therapy requirements for certain conditions. 
Analysis: HB185 makes modifications to step therapy guidelines that effect multiple health insurance statutes including the Health Care Purchasing Act, The Public Assistance Act, The New Mexico Insurance Code, The Health Maintenance Organization Law and the Nonprofit Health Care Plan Law. 
In certain instances such as the Secretary of a department, is to be responsible for implementing changes to the step therapy requirements as found in the Public Assistance Act. 
New language now state: step therapy protocols that are required shall establish clinical review criteria for those step therapy protocols. The clinical review criteria shall be based on clinical practice guidelines that: (1) recommend that the prescription drugs subject to step therapy protocols be taken in the specific sequence required by the step therapy protocol,
And  (2) are developed and endorsed by an interdisciplinary panel of experts that manages conflicts of interest among the members of the panel of experts by: (a) requiring members to: 1) disclose any potential conflicts of interest with group health plan administrators, insurers, health maintenance organizations, health care plans, pharmaceutical manufacturers, pharmacy benefits managers and any other entities; and 2) recuse themselves if there is a conflict of interest; and (b) using analytical and methodological experts to work to provide objectivity in data analysis and ranking of evidence through the preparation of evidence tables and facilitating consensus; (3) are based on high-quality studies, research and medical practice, and  
(4) are created pursuant to an explicit and transparent process that: (a) minimizes bias and conflicts of interest; (b) explains the relationship between treatment options and outcomes; (c) rates the quality of the evidence supporting recommendations; and (d) considers relevant patient subgroups and preferences; and (5) consider the needs of atypical patient populations and diagnoses. 
Peer reviewed publications may used if clinical guidelines are not available.
When a health plan restricts coverage of a prescription drug for the treatment of any medical condition through the use of a step therapy protocol, an enrollee and the practitioner prescribing the prescription drug shall have access to a clear, readily accessible and convenient process to request a step therapy exception determination.
A health plan may use its existing process as long as it contains the processes stated above as part of that medical exception process, as long as the plan makes available on its publicly accessible  website.
A group health plan shall expeditiously grant an exception to the group health plan's step therapy protocol, based on medical necessity and a clinically valid explanation from the patient's prescribing practitioner as to why a drug on the plan's formulary that is therapeutically equivalent to the prescribed drug should not be substituted for the prescribed drug.
Reasons for not allowing the substitution may include , (1) the prescription drug that is the subject of the exception request is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient; (2) the prescription drug that is the subject of the exception request is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen; (3) while under the enrollee's current health coverage or previous health coverage, the enrollee has tried the prescription drug that is the subject of the exception request or another prescription drug in the same pharmacologic class or with the same mechanism of action as the prescription drug that is the subject of the exception request and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or (4) the prescription drug required pursuant to the step therapy protocol is not in the best interest of the patient, based on clinical appropriateness, because the patient's use of the prescription drug is expected to: (a) cause a significant barrier to the patient's adherence to or compliance with the patient's plan of care; (b) worsen a comorbid condition of the patient; or (c) decrease the patient's ability to achieve or maintain reasonable functional ability in performing daily activities.
Once granting an exception, the exception will remain in existence for the life of the patient for that exception. 
A response from the plan is expected with in seventy-two hours of the request for exception. Under certain circumstances a response is expected with in twenty-four hours. 
A rejection of a request for exception shall be subject to the appeal process found in the Patient Protection Act.
 
A health plans may not be prohibited from allowing  for prescribing generic equivalent drugs, and also, a practitioner from prescribing a prescription drug that the practitioner has determined to be medically necessary.
The effective date of these modification to the step therapy protocol will January 1, 2025.

Medical necessity, or ,medically necessary, means health care services determined by a practitioner, in consultation with the group health plan administrator, to be appropriate or necessary according to: (1) any applicable, generally accepted principles and practices of good medical care; (2) practice guidelines developed by the federal government or national or professional medical societies, boards or associations; or (3) any applicable clinical protocols or practice guidelines developed by the group health plan consistent with federal, national and professional practice guidelines. These standards shall be applied to decisions related to the diagnosis or direct care and treatment of a physical or behavioral health condition, illness, injury, or disease.

Section 59A-22B-8 NMSA 1978 (being Laws 2023, Chapter 114, Section 13) refers to the prohibition of prior authorization and step therapy for drugs prescribed for substance abuse. New language in SB185 reads: Coverage for medication approved by the federal food and drug administration that is prescribed for the treatment of an autoimmune disorder, a behavioral health condition, cancer or a substance use disorder, pursuant to a health care provider's medical necessity determination, shall not be subject to prior authorization, except in cases in which a generic version is available.

Also, a health insurer shall not impose step therapy requirements before authorizing coverage for medication approved by the federal food and drug administration that is prescribed for the treatment of an autoimmune disorder, a behavioral health condition, cancer or a substance use disorder, pursuant to a health care provider's medical necessity determination, except in cases in which a generic version is available. 
The reference above to auto immune disorders is new language as part of this bill. 



 

 Amended February 2,2024 in HHHC
HHHC/HB185 The House Health and Human Services Committee Substitute shall require that an exemption of a step therapy protocol will require that the group health administrator shall approve an exception for the life of the patient. Also, a group health plan shall include in its evidence of coverage, language describing the enrollee’s rights regarding step therapy exceptions. This refers to Section 1 requiring step therapy protocols. The same language regarding enrollees rights applies to health maintenance contracts, individual and group health plans.
Drugs for auto-immune, behavioral health conditions, and cancer are not subject to step therapy. 
An earlier reference to applicability of the Act by January 1, 2019 is struck.