HOUSE OF REPRESENTATIVES

H.B. NO.

1289

TWENTY-NINTH LEGISLATURE, 2017

 

STATE OF HAWAII

 

 

 

 

 

 

A BILL FOR AN ACT

 

 

relating to PRESCRIPTION DRUGS.

 

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 


     SECTION 1.  The legislature finds that health insurance plans are increasingly making use of step therapy protocols under which patients are required to try one or more prescription drug alternatives before coverage is provided for the particular prescription drug selected by the patient's health care provider.  Step therapy protocols can play an important role in controlling health care costs when they are based on well-developed scientific standards and administered in a flexible manner that takes into account the individual needs of patients.  However, 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 required prescription drug alterative or may suffer harm if the step therapy protocol requires use of a drug that is inappropriate for the patient.

The legislature further finds that without uniform statewide policies in place for step therapy protocols, Hawaii residents' access to appropriate treatment may be dependent upon their insurance carrier instead of on their medical provider.  It is imperative that step therapy protocols in the State preserve heath care providers' right to make treatment decisions in the best interest of the patient.

The legislature finds that it is necessary for the protection of public health and safety to require health insurers to base step therapy protocols on appropriate clinical practice guidelines or published peer review data developed by independent experts with knowledge of the condition or conditions under consideration.  To protect the interest of patients statewide, step therapy protocols must include provisions to exempt patients for whom step therapy would be inappropriate to ensure that patients have access to a fair, transparent, and independent process for requesting an exemption to a step therapy protocol when the patients' physician deems it to be appropriate.

     The purpose of this Act is to require all insurers in the State to adopt minimum standards including clinical review criteria and procedural transparency to preserve the health and safety of Hawaii's residents.

     SECTION 2.  Chapter 431, Hawaii Revised Statutes, is amended by adding a new section to article 10A to be appropriately designated and to read as follows:

     "§431:10A-    Step therapy protocol; exceptions.  (a)  Clinical review criteria used to establish a step therapy protocol shall:

     (1)  Be based on clinical practice guidelines that recommend that the prescription drugs shall be taken in the specific sequence required by the step therapy protocol; and

         (A)  Were developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by:

              (i)  Requiring members to disclose any potential conflict of interests with entities, including insurers, health plans, and pharmaceutical manufacturers and recuse themselves of voting if they have a conflict of interest;

             (ii)  Using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through preparing evidence tables and facilitating consensus; and

            (iii)  Offering opportunities for public review and comments;

         (B)  Are based on high quality studies, research, and medical practices that employ explicit and transparent processes to:

              (i)  Minimize biases and conflicts of interest;

             (ii)  Explain the relationship between treatment options and outcomes;

            (iii)  Rate the quality of the evidence supporting recommendations; and

             (iv)  Consider relevant patient subgroups and preferences;

     (4)  Be continually updated through a review of new evidence, research, and newly developed treatments; and

     (5)  Take into account the needs of atypical patient populations and diagnoses.

     No insurer, utilization review organization, or health care provider shall be required to create any new entity to develop clinical review criteria used for step therapy protocols.  In the absence of the capacity to meet any requirement of this subsection, peer reviewed publications may be relied upon.

     (b)  When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer or utilization review organization through the use of a step therapy protocol, the patient and the prescribing practitioner shall have access to a clear, readily accessible, and convenient process to request a step therapy exception determination, which shall be publicly available through the insurer or utilization review organization's website.  An insurer or utilization review organization may use its existing medical exceptions or appeal process to satisfy this requirement; provided that the process complies with the requirements of this section.

     (c)  A step therapy exception shall be granted if, regardless of any current or prior insurance coverage, the patient's relevant medical condition is currently stabilized by a particular prescription drug prescribed by the patient's health care provider and the patient's health care provider has prescribed continued treatment with the same prescription drug.  A step therapy exception shall be granted to a patient whose relevant medical condition is not currently stabilized by a particular prescription drug if any prescription drug required under the applicable step therapy protocol:

     (1)  Is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient;

     (2)  Is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug;

     (3)  Has been previously prescribed to the patient or is in the same pharmacologic class or has the same mechanism of action as another prescription drug that has been prescribed to the patient and was discontinued by the patient's health care provider due to lack of efficacy or effectiveness, diminished effect, or an adverse event, regardless of any current or prior insurance coverage of the prescription drug; or

     (4)  Will not serve the best interest of the patient, based on medical necessity.

     (d)  An insurer or utilization review organization shall make a step therapy exception determination within seventy-two hours of receipt of a request for determination or filing of an appeal or within twenty-four hours if exigent circumstances exist.  If no determination has been made within the time specified, the exception shall be deemed to be granted.

     Upon the grant of a step therapy exception, the insurer or utilization review organization shall authorize coverage for the particular prescription drug prescribed by the patient's health care provider.  Any adverse determination under this subsection shall be subject to appeal pursuant to the insurer or utilization review organization's existing appeal procedures.

     (e)  Every insurer or utilization review organization subject to this section shall certify annually to the insurance commissioner that the insurer or utilization review organization's step therapy protocol meets the requirements of this section.  Any proposed change in protocol or clinical review criteria shall be submitted to the insurance commissioner for approval before it may be implemented by the insurer or organization. 

     (f)  Nothing in this section shall be interpreted to prevent:

     (1)  An insurer or utilization review organization from requiring a patient to try an AB-rated generic equivalent drug prior to providing coverage for a name-brand prescription drug; or

     (2)  A health care provider from prescribing any prescription drug that the provider finds to be medically appropriate for the patient.

     (g)  As used in this section, unless the context indicates otherwise:

     "AB-rated generic equivalent drug" means a prescription drug product that is considered by the federal Food and Drug Administration to be therapeutically equivalent to a particular name brand prescription drug.

     "Clinical practice guidelines" means a systematically developed statement to assist decisionmaking by health care providers and patients about appropriate health care for specific clinical circumstances and conditions.

     "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by an insurer or utilization review organization to determine the medical necessity and appropriateness of health care services.

     "Step therapy protocol" means a protocol or program that requires the use of specified prescription drugs in a specific sequence as a condition of coverage under a pharmacy or medical benefit plan.

     "Step therapy exception determination" means a determination as to whether a step therapy protocol should apply in a particular situation or be overridden in favor of immediate coverage of a health care provider's selected prescription drug based on a review of the patient's or prescriber's request for an override, along with supporting rationale and documentation.

     "Utilization review organization" means an entity that conducts utilization reviews, other than an insurer that performs utilization reviews for its own policies."

     SECTION 3.  Chapter 432, Hawaii Revised Statutes, is amended by adding a new section to article 1 to be appropriately designated and to read as follows:

     "§432:1-    Step therapy protocol; exceptions.  (a)  Clinical review criteria used to establish a step therapy protocol shall:

     (1)  Be based on clinical practice guidelines that recommend that the prescription drugs shall be taken in the specific sequence required by the step therapy protocol; and

         (A)  Were developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by:

              (i)  Requiring members to disclose any potential conflict of interests with entities, including insurers, health plans, and pharmaceutical manufacturers and recuse themselves of voting if they have a conflict of interest;

             (ii)  Using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through preparing evidence tables and facilitating consensus; and

            (iii)  Offering opportunities for public review and comments;

         (B)  Are based on high quality studies, research, and medical practices that employ explicit and transparent processes to:

              (i)  Minimize biases and conflicts of interest;

             (ii)  Explain the relationship between treatment options and outcomes;

            (iii)  Rate the quality of the evidence supporting recommendations; and

             (iv)  Consider relevant patient subgroups and preferences;

     (4)  Be continually updated through a review of new evidence, research, and newly developed treatments; and

     (5)  Take into account the needs of atypical patient populations and diagnoses.

     No mutual benefit society, utilization review organization, or health care provider shall be required to create any new entity to develop clinical review criteria used for step therapy protocols.  In the absence of the capacity to meet any requirement of this subsection, peer reviewed publications may be relied upon.

     (b)  When coverage of a prescription drug for the treatment of any medical condition is restricted for use by a mutual benefit society or utilization review organization through the use of a step therapy protocol, the patient and the prescribing practitioner shall have access to a clear, readily accessible, and convenient process to request a step therapy exception determination, which shall be publicly available through the mutual benefit society or utilization review organization's website.  An mutual benefit society or utilization review organization may use its existing medical exceptions or appeal process to satisfy this requirement; provided that the process complies with the requirements of this section.

     (c)  A step therapy exception shall be granted if, regardless of any current or prior insurance coverage, the patient's relevant medical condition is currently stabilized by a particular prescription drug prescribed by the patient's health care provider and the patient's health care provider has prescribed continued treatment with the same prescription drug.  A step therapy exception shall be granted to a patient whose relevant medical condition is not currently stabilized by a particular prescription drug if any prescription drug required under the applicable step therapy protocol:

     (1)  Is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient;

     (2)  Is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug;

     (3)  Has been previously prescribed to the patient or is in the same pharmacologic class or has the same mechanism of action as another prescription drug that has been prescribed to the patient and was discontinued by the patient's health care provider due to lack of efficacy or effectiveness, diminished effect, or an adverse event, regardless of any current or prior insurance coverage of the prescription drug; or

     (4)  Will not serve the best interest of the patient, based on medical necessity.

     (d)  A mutual benefit society or utilization review organization shall make a step therapy exception determination within seventy-two hours of receipt of a request for determination or filing of an appeal or within twenty-four hours if exigent circumstances exist.  If no determination has been made within the time specified, the exception shall be deemed to be granted.

     Upon the grant of a step therapy exception, the mutual benefit society or utilization review organization shall authorize coverage for the particular prescription drug prescribed by the patient's health care provider.  Any adverse determination under this subsection shall be subject to appeal pursuant to the mutual benefit society or utilization review organization's existing appeal procedures.

     (e)  Every mutual benefit society or utilization review organization subject to this section shall certify annually to the insurance commissioner that the mutual benefit society or utilization review organization's step therapy protocol meets the requirements of this section.  Any proposed change in protocol or clinical review criteria shall be submitted to the insurance commissioner for approval before it may be implemented by the mutual benefit society or utilization review organization.

     (f)  Nothing in this section shall be interpreted to prevent:

     (1)  A mutual benefit society or utilization review organization from requiring a patient to try an AB-rated generic equivalent drug prior to providing coverage for a name-brand prescription drug; or

     (2)  A health care provider from prescribing any prescription drug that the provider finds to be medically appropriate for the patient.

     (g)  As used in this section, unless the context indicates otherwise:

     "AB-rated generic equivalent drug" means a prescription drug product that is considered by the federal Food and Drug Administration to be therapeutically equivalent to a particular name brand prescription drug.

     "Clinical practice guidelines" means a systematically developed statement to assist decision making by health care providers and patients about appropriate health care for specific clinical circumstances and conditions.

     "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a mutual benefit society or utilization review organization to determine the medical necessity and appropriateness of health care services.

     "Step therapy protocol" means a protocol or program that requires the use of specific prescription drugs in a specific sequence as a condition of coverage under a pharmacy or medical benefit plan.

     "Step therapy exception determination" means a determination as to whether a step therapy protocol should apply in a particular situation or be overridden in favor of immediate coverage of a health care provider's selected prescription drug based on a review of the patient's or prescriber's request for an exception and supporting rationale and documentation.

     "Utilization review organization" means an entity that conducts utilization reviews, other than a mutual benefit society that performs utilization reviews for its own health benefit plans."

     SECTION 4.  Section 432D:23, Hawaii Revised Statutes, is amended to read as follows:

     "§432D-23  Required provisions and benefits.  Notwithstanding any provision of law to the contrary, each policy, contract, plan, or agreement issued in the State after January 1, 1995, by health maintenance organizations pursuant to this chapter, shall include benefits provided in sections 431:10-212, 431:10A-115, 431:10A-115.5, 431:10A-116, 431:10A-116.2, 431:10A-116.5, 431:10A-116.6, 431:10A-119, 431:10A-120, 431:10A-121, 431:10A-122, 431:10A-125, 431:10A-126, 431:10A-132, 431:10A-133, 431:10A-140, [and] 431:10A-134, and 431:10A-    and chapter 431M."

     SECTION 5.  This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun before its effective date.

     SECTION 6.  Statutory material to be repealed is bracketed and stricken.  New statutory material is underscored.

     SECTION 7.  This Act shall take effect upon its approval, and shall apply to all health insurance and health benefit plans, contracts, and agreements issued or renewed in this State after December 31, 2017.

 

INTRODUCED BY:

_____________________________



 

Report Title:

Health Insurance; Prescription Drugs; Step Therapy Protocol

 

Description:

Establishes requirements for step therapy protocols to ensure patient access to the particular prescription drugs prescribed by health care providers.  Establishes insurance coverage requirements and standards for appeal of coverage determinations.

 

 

 

The summary description of legislation appearing on this page is for informational purposes only and is not legislation or evidence of legislative intent.