SECTION 1. Chapter 111 of the General Laws is hereby amended by adding the following section:-

Section 237. There shall be a commission on step therapy protocols within the department. The commission shall consist of: the commissioner of public health or the commissioner’s designee, who shall chair the commission; the commissioner of insurance or the commissioner’s designee; the director of MassHealth or the director’s designee; the director of the Center of Health Information and Analysis or the director’s designee; a member representing the Massachusetts Public Health Association; and 3 members to be selected by the Governor including: a member representing one of the top five health insurance companies in Massachusetts according to market share, a member representing a patient advocacy organization, and a member currently practicing as a licensed physician in Massachusetts.             

The commission on step therapy protocol shall study and assess the implementation of step therapy process reforms. The study shall address the impact of step therapy protocols on total medical expenses, health care quality outcomes, and costs to the Massachusetts health care system. The study shall also examine the impact of step therapy protocols on health disparities as relates to outcomes, access and medication adherence in the Commonwealth.

The commission shall convene no later than ninety days of the effective date of this act and meet as needed to meet the reporting requirements of this section.

The commission on step therapy protocols shall submit to the secretary of health and human services and the joint committee public health, nine months after the effective date of this act and annually thereafter, a report that includes findings from the commission’s review along with recommendations and any suggested legislation to implement those recommendations.  

SECTION 2. Commercial Health Insurance Step Therapy Exceptions

(a)(1) “Clinical practice guidelines” means a systematically developed statement to assist decision making by health care providers and patient decisions about appropriate healthcare for specific clinical circumstances and conditions.

(2) “Clinical review criteria” means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of healthcare services.

(3) “Medically necessary” mean health services and supplies that under the applicable standard of care are appropriate: (a) to improve or preserve health, life, or function;  (b) to slow the deterioration of health, life, or function; or (c) for the early screening, prevention, evaluation, diagnosis or treatment of a disease, condition, illness or injury.

(4) “Step therapy protocol” means a protocol, policy, or program that establishes the specific sequence in which prescription drugs for a specified medical condition and medically appropriate for a particular patient are covered by an insurer or health plan.

(5) “Step therapy exception” means that a step therapy protocol should be overridden in favor of immediate coverage of the health care provider’s selected prescription drug.

(6) “Utilization review organization” means an entity that conducts utilization review, other than a insurer or health plan performing utilization review for its own health benefit plans.

(b)(1) Clinical review criteria used to establish a step therapy protocol shall be based on clinical practice guidelines that:

(A) Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.

(B) Are 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 from 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 the preparation of evidence tables and facilitating consensus.

(iii) Offering opportunities for public review and comments.

(C) Are based on high quality studies, research, and medical practice.

(D) Are created by an explicit and transparent process that:

(i) Minimizes biases and conflicts of interest;

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

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

(iv) Considers relevant patient subgroups and preferences.

(E) Are continually updated through a review of new evidence, research and newly developed treatments.

(2) In the absence of clinical guidelines that meet the requirements in subsection (b)(1) of this section, peer reviewed publications may be substituted.

(3) When establishing a step therapy protocol, a utilization review agent shall also take into account the needs of atypical patient populations and diagnoses when establishing clinical review criteria.

(4) This section shall not be construed to require insurers, health plans or the state to set up a new entity to develop clinical review criteria used for step therapy protocols.

(c)(1) When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, or utilization review organization through the use of a step therapy protocol, the patient and prescribing practitioner shall have access to a clear readily accessible and convenient process to request a step therapy exception. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be made easily accessible on the insurer’s, health plan’s, or utilization review organization’s website.

(2) A step therapy exception shall be expeditiously granted if:

(A) The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient;

(B) The required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen;

(C) The patient has tried the required prescription drug while under their current or a previous health insurance or health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;

(D) The required prescription drug is not in the best interest of the patient, based on medical necessity.

(E) The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan.

(3) Upon the granting of a step therapy exception, the insurer, health plan, or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient’s treating health care provider.

(4) The insurer, health plan, or utilization review organization shall grant or deny a step therapy exception request or an appeal within seventy-two hours of receipt. In cases where exigent circumstances exist an insurer, health plan, or utilization review organization shall respond within twenty-four hours of receipts. Should a response by an insurer, health plan, or utilization review organization not be received within the time allotted, the exception or appeal shall be deemed granted.

(5) This section shall apply to [LIST ALL STATE REGULATED COMMERCIAL PLAN TYPES] that provide coverage of a prescription drug pursuant to a policy that meets the definition of a medication step therapy protocol as defined in this Act, regardless of whether the policy is described as a step therapy protocol.

(d)  Any step therapy exception as defined in this Act shall be eligible for appeal by an insured.

(e) Notwithstanding any law to the contrary, the [Division of Insurance] shall promulgate any regulations necessary to enforce this section.

(f) This Act shall apply only to a health insurance and/or health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2020.

SECTION 3. Medicaid Program Step Therapy Exceptions

(a) “Medically necessary,” “step therapy protocol,” “step therapy exception,” and “utilization review organization” shall have the same meaning in this section as in Section 1.

(b)(1) On or after January 1, 2020, when coverage of a prescription drug for the treatment of any medical condition is restricted for use by MassHealth, or by a managed care organization or utilization review organization contracted with MassHealth to provide coverage to Medicaid recipients, through the use of a step therapy protocol, a request for exception from such requirements shall be expeditiously granted if:

(A) The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient;

(B) The required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen;

(C) The patient has tried the required prescription drug while covered under MassHealth, a managed care organization or utilization review organization contracted with MassHealth or a previous health insurance or health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;

(D) The required prescription drug is not in the best interest of the patient, based on medical necessity.

(E) The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration while covered under MassHealth, a managed care organization or utilization review organization contracted with MassHealth or previous health insurance or health benefit plan.

(2) Upon the granting of a step therapy exception, MassHealth or a managed care organization or utilization review organization contracted with MassHealth shall authorize coverage for the prescription drug prescribed by the patient’s treating health care provider.

(3) The MassHealth or a managed care organization or utilization review organization contracted with MassHealth review process for step therapy exception requests shall meet the requirements set forth in 1972(d)(5)(A) of the federal Social Security Act.

Section 3. Limitations

(a) Nothing in this Act shall not be construed to prevent:

(1) A pharmacist from effecting substitutions of prescription drugs consistent with [insert state pharmacy substitution law reference(s)].

(2) A health care provider from prescribing a prescription drug that is determined to be medically appropriate.