This bill sets specifications on the development and use of and exceptions to
step therapy protocols for prescription drug coverage. A step therapy protocol, as
defined in the bill, is a protocol that establishes the specific sequence in which
prescription drugs for a specified medical condition that are medically appropriate
for a particular patient are covered by a policy or plan. When establishing a step
therapy protocol, an insurer, pharmacy benefit manager, or utilization review
organization must use clinical review criteria based on clinical practice guidelines
that meet certain criteria specified in the bill.

If an insurer, pharmacy benefit manager, or utilization review organization
restricts the coverage of a prescription drug through a step therapy protocol, the
insurer, pharmacy benefit manager, or utilization review organization must provide
access to a process to request an exception to the step therapy protocol, though an
existing medical exceptions process may be used to satisfy this requirement. The
insurer, pharmacy benefit manager, or utilization review organization must grant an
exception to the step therapy protocol if the prescribing provider submits complete,
clinically relevant written documentation supporting the request and any of the

circumstances specified in the bill apply, including when the drug is contraindicated
for the patient or will likely cause a serious adverse event for the patient; the drug
is expected to be ineffective based on certain evidence and the known characteristics
of the patient and the drug regimen; the patient previously tried the drug or a similar
drug and its use by the patient was discontinued under circumstances described in
the bill; or the patient is stable on a different drug under this or a previous policy or
plan. Upon granting an exception to the step therapy protocol, the insurer, pharmacy
benefit manager, or utilization review organization must authorize coverage for the
drug prescribed by the patient's treating health care provider to the extent the drug
is covered under the patient's policy or plan. An insured may appeal a denied request
for an exception to the step therapy protocol. An insurer, pharmacy benefit manager,
or utilization review organization must grant or deny a request for an exception
within three business days, or by the end of the next business day in exigent
circumstances, of receipt of supporting documentation. If this deadline is not met,
the exception is considered granted.