2016 -- S 2694

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LC005326

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2016

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A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -

STEP THERAPY PROTOCOL

     Introduced By: Senators Gallo, and Lynch Prata

     Date Introduced: March 08, 2016

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness

Insurance Policies" is hereby amended by adding thereto the following sections:

     27-18-82. Definitions. -- (a) As used in this chapter:

     (1) "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.

     (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 health care services.

     (3) "Medically necessary" means health services and supplies that under the applicable

standard of care are appropriate:

     (i) To improve or preserve health, life, or function; or

     (ii) To slow the deterioration of health, life, or function; or

     (iii) For the early screening, prevention, evaluation, diagnosis, or treatment of a disease,

condition, illness, or injury.

     (4) "Step therapy override exception determination" means a determination as to whether

a step therapy protocol should apply in a particular situation, or whether the step therapy protocol

should be overridden in favor of immediate coverage of the health care provider's selected

prescription drug. This determination is based on a review of the patient's or prescriber's request

for an override, along with supporting rationale and documentation.

     (5) "Step therapy protocol" means a protocol 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.

     (6) "Utilization review organization" means an entity that conducts a utilization review,

other than an insurer or health plan performing utilization reviews for its own health benefit

plans.

     27-18-83. Exceptions process transparency. -- (a) Exceptions process. 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 determination. 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 insurers, health plans, or

utilization review organization's website.

     (b) Exceptions. A step therapy override exception determination request shall be

expeditiously granted if:

     (1) The required prescription drug is contraindicated, or will likely cause an adverse

reaction or physical or mental harm to the patient;

     (2) 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;

     (3) 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;

     (4) The required prescription drug is not in the best interest of the patient based on

medical necessity;

     (5) The patient is stable on a prescription drug selected by their health care provider for

the medical condition under consideration;

     (6) The required prescription drug is likely to be diverted.

     (c) Effect of exception. Upon the granting of a step therapy override exception

determination, the insurer, health plan, or utilization review organization shall authorize coverage

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for the prescription drug prescribed by the patient's treating health care provider.

     (d) Limitations. This section shall not be construed to prevent:

     (1) An insurer, health plan, or utilization review organization from requiring a patient to

try an AB-rated generic equivalent prior to providing coverage for the equivalent branded

prescription drug;

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

medically appropriate.

     27-18-84. Regulations. – Notwithstanding any provision of the general or public laws to

the contrary, the office of the health insurance commissioner shall promulgate any regulations

necessary to enforce the provisions of §§27-18-82 and 27-18-83 in accordance with the

provisions of chapter 35 of title 42 ("administrative procedures act").

     SECTION 2. This act shall take effect upon passage and shall apply only to health

insurance and health benefit plans delivered, issued for delivery, or renewed on or after June 1,

2016.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -

STEP THERAPY PROTOCOL

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     This act would allow for a step therapy exception determination when coverage of a

prescription drug for the treatment of a medical condition is restricted for use by an insurer,

health plan, or utilization review organization.

     This act shall take effect upon passage and shall apply only to health insurance and health

benefit plans delivered, issued for delivery, or renewed on or after June 1, 2016.

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LC005326

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