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2016 SESSION

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16102546D
SENATE BILL NO. 332 Offered January 13, 2016 Prefiled January 8, 2016 A BILL to amend the Code of Virginia by adding a section numbered 38.2-3407.13:3, relating to accident and sickness insurance; step therapy protocols. ---------- Patron-- DeSteph ---------- Referred to Committee on Commerce and Labor ----------

Be it enacted by the General Assembly of Virginia:

1. That the Code of Virginia is amended by adding a section numbered 38.2-3407.13:3 as follows:

§ 38.2-3407.13:3. Step therapy protocols.

A. As used in this section:

"Carrier" means any (i) insurer issuing individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis; (ii) corporation providing individual or group accident and sickness subscription contracts; or (iii) health maintenance organization providing a health care plan for health care services.

"Covered person" means a policyholder, subscriber, enrollee, participant, or other individual covered by a health benefit plan.

"Health benefit plan" means a policy, contract, certificate, or agreement offered by a carrier to provide, deliver, arrange for, pay for, or reimburse any of the costs of services for the diagnosis, prevention, treatment, cure, or relief of a health condition, illness, injury, or disease, and that provides coverage for prescription drugs.

"Provider" means a hospital, physician, or any type of provider licensed, certified, or authorized by statute to provide a covered service under the health benefit plan.

"Step therapy override determination" means a determination, based on a review of the covered person's or prescriber's request for an override along with supporting rationale and documentation, 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 provider's selected prescription drug.

"Step therapy protocol" means a protocol or program that (i) establishes the specific sequence in which prescription drugs for a specified medical condition are medically appropriate for a particular covered person and are covered by a health benefit plan or (ii) in any way conditions coverage of a prescription medication on a covered person's first trying an alternative medication without success.

"Utilization review entity" has the same meaning ascribed to the term in § 32.1-137.7.

B. Any carrier that offers a health benefit plan that restricts the use of any prescription drug for the treatment of any health condition, illness, injury, or disease through the use of a step therapy protocol shall have in place a clear, convenient, and expeditious process for a prescribing provider to request an override of such restrictions for a given enrollee, such that if the request is granted by the insurer the step therapy protocol shall not apply to the prescription drug for that enrollee. The process shall be made easily accessible on the carrier's or utilization review entity's website. The insurer shall notify each prescribing provider in writing of the procedures for submitting such a request.

C. A step therapy protocol override determination request shall be expeditiously granted if any of the following apply:

1. The required prescription drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the covered person;

2. The required prescription drug is expected to be ineffective on the basis of the known relevant physical or mental characteristics of the covered person and the known characteristics of the prescription drug regimen;

3. The covered person has tried the required prescription drug while under his current or a previous 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; or

4. The required prescription drug is not in the best interest of the covered person, based on medical appropriateness.

D. A carrier shall not require a step therapy protocol for any prescription drug prescribed for a covered person who previously has satisfied a step therapy protocol with respect to that prescription drug, or for whom the step therapy protocol has been overridden with respect to that prescription drug, provided that the covered person or the prescribing provider submits documentation demonstrating to the insurer that the step therapy protocol has been overridden.