                                 CODE OF VIRGINIA

STEP THERAPY PROTOCOLS (§ 38.2-3407.9:05)

A. As used in this section:
			&#8220;Carrier&#8221; 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. &#8220;Carrier&#8221; includes any entity
administering a policy or plan providing health insurance coverage to state
employees pursuant to &#xA7; 2.2-2818 but does not include any entity
administering a policy or plan providing coverage pursuant to Title XVIII of the
Social Security Act, 42 U.S.C. &#xA7; 1395 et seq. (Medicare); Title XIX of the
Social Security Act, 42 U.S.C. &#xA7; 1396 et seq. (Medicaid); or Title XXI of
the Social Security Act, 42 U.S.C. &#xA7; 1397aa et seq. (CHIP).
			&#8220;Clinical practice guideline&#8221; means a systematically developed
statement to assist decision making by providers about appropriate health care
for a specific clinical circumstance or condition.
			&#8220;Clinical review criteria&#8221; means the written screening
procedures, decision abstracts, clinical protocols, and practice guidelines used
by a carrier, utilization review organization, or independent review
organization to determine the medical necessity and appropriateness of a health
care service.
			&#8220;Health benefit plan&#8221; 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. &#8220;Health benefit plan&#8221;
includes any policy or plan providing health insurance coverage to state
employees pursuant to &#xA7; 2.2-2818.
			&#8220;Patient&#8221; means a policyholder, subscriber, participant, or other
individual covered by a health benefit plan.
			&#8220;Provider&#8221; 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.
			&#8220;Step therapy exception&#8221; means overriding a step therapy protocol
in favor of immediate coverage of the provider&#8217;s selected prescription
drug provided that such drug is covered under the health benefit plan, which
determination is based on a review of the patient&#8217;s or prescribing
provider&#8217;s request for an override, along with supporting rationale and
documentation.
			&#8220;Step therapy protocol&#8221; means a protocol setting the sequence in
which prescription drugs for a specified medical condition and medically
appropriate for a particular patient are covered under a health benefit plan.
			&#8220;Utilization review organization&#8221; means an entity that conducts
utilization review, other than a carrier performing utilization review for its
own health benefit plans.

B. Carriers or utilization review organizations that develop step therapy
protocols for a health benefit plan shall ensure that those step therapy
protocols:

   1. 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 requiring members to disclose to the carrier any potential conflict
   of interest, including carriers and pharmaceutical manufacturers, and recuse
   themselves of voting if they have a conflict of interest;

   2. Are based on peer-reviewed research and medical practice, and may also
   consider published clinical practice guidelines established for relevant
   patient subgroups in addition to or in the absence of peer-reviewed research;
   and

   3. Are continually updated based on a review of new evidence, research, and
   newly developed treatments.

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

D. This section shall not be construed to require carriers to set up a new
entity to develop clinical review criteria used for step therapy protocols.

E. When coverage of a prescription drug for the treatment of any medical
condition is restricted for use by a carrier or utilization review organization
through the use of a step therapy protocol, the patient and prescribing provider
shall have access to a clear, readily accessible, and convenient process to
request a step therapy exception. A carrier or utilization review organization
may use its existing medical exceptions process to satisfy this requirement. The
process shall be made easily accessible on the carrier&#8217;s or utilization
review organization&#8217;s website.

F. A step therapy exception request shall be granted if the prescribing
provider&#8217;s submitted justification and supporting clinical documentation,
if needed, are determined to support the prescribing provider&#8217;s statement
that:

   1. The required prescription drug is contraindicated;

   2. The required drug would 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 step therapy-required prescription drug while
   under their current or a previous health benefit plan, and such prescription
   drug was discontinued due to lack of efficacy or effectiveness, diminished
   effect, or an adverse event; or

   4. The patient is currently receiving a positive therapeutic outcome on a
   prescription drug recommended by his provider for the medical condition under
   consideration while on a current or the immediately preceding health benefit
   plan.

G. Upon the granting of a step therapy exception, the carrier or utilization
review organization shall authorize coverage for the prescription drug
prescribed by the patient&#8217;s treating provider, provided that the
prescription drug is covered under the current health benefit plan.

H. The carrier or utilization review organization shall respond to a step
therapy exception request within 72 hours of receipt, including hours on
weekends, that the request is approved, denied, or requires supplementation. In
cases where exigent circumstances exist, a carrier or utilization review
organization shall respond within 24 hours of receipt, including hours on
weekends, that the request is approved, denied, or requires supplementation.

I. A patient may appeal any step therapy exception request denial made pursuant
to this section under the health benefit plan&#8217;s existing appeal
procedures.

J. Drug samples shall not be considered trial and failure of a preferred drug.

K. This section shall not be construed to prevent a carrier or utilization
review organization from requiring an enrollee to try an AB-rated generic
equivalent or interchangeable biological product prior to providing coverage, or
substitute a generic for a branded drug.

L. Pursuant to the authority granted by &#xA7; 38.2-223, the Commission may
promulgate such rules and regulations as it may deem necessary to implement this
section.

M. This section shall apply to any health benefit plan delivered, issued for
delivery, or renewed on or after January 1, 2020.

HISTORY: 2019, c. 337.