HF 3196

1st Engrossment - 90th Legislature (2017 - 2018) Posted on 05/23/2018 03:10pm

A bill for an act
relating to health insurance; establishing a step therapy protocol and override for
prescription drug coverage; proposing coding for new law in Minnesota Statutes,
chapter 62Q.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

[62Q.184] STEP THERAPY OVERRIDE.

Subdivision 1.

Definitions.

(a) For the purposes of this section, the terms in this
subdivision have the meanings given them.

(b) "Clinical practice guideline" means a systematically developed statement to assist
health care providers and enrollees in making decisions about appropriate health care services
for specific clinical circumstances and conditions developed independently of a health plan
company, pharmaceutical manufacturer, or any entity with a conflict of interest.

(c) "Clinical review criteria" means the written screening procedures, decision abstracts,
clinical protocols, and clinical practice guidelines used by a health plan company to determine
the medical necessity and appropriateness of health care services.

(d) "Health plan company" has the meaning given in section 62Q.01, subdivision 4, but
does not include a managed care organization or county-based purchasing plan participating
in a public program under chapters 256B or 256L, or an integrated health partnership under
section 256B.0755.

(e) "Step therapy protocol" means a protocol or program that establishes the specific
sequence in which prescription drugs for a specified medical condition, including
self-administered and physician-administered drugs, are medically appropriate for a particular
enrollee and are covered under a health plan.

(f) "Step therapy override" means that the step therapy protocol is overridden in favor
of coverage of the selected prescription drug of the prescribing health care provider because
at least one of the conditions of subdivision 3, paragraph (a), exists.

Subd. 2.

Establishment of a step therapy protocol.

A health plan company shall
consider available recognized evidence-based and peer-reviewed clinical practice guidelines
when establishing a step therapy protocol. Upon written request of an enrollee, a health plan
company shall provide any clinical review criteria applicable to a specific prescription drug
covered by the health plan.

Subd. 3.

Step therapy override process; transparency.

(a) When coverage of a
prescription drug for the treatment of a medical condition is restricted for use by a health
plan company through the use of a step therapy protocol, enrollees and prescribing health
care providers shall have access to a clear, readily accessible, and convenient process to
request a step therapy override. The process shall be made easily accessible on the health
plan company's Web site. A health plan company may use its existing medical exceptions
process to satisfy this requirement. A health plan company shall grant an override to the
step therapy protocol if at least one of the following conditions exist:

(1) the prescription drug required under the step therapy protocol is contraindicated
pursuant to the pharmaceutical manufacturer's prescribing information for the drug or, due
to a documented adverse event with a previous use or a documented medical condition,
including a comorbid condition, is likely to do any of the following:

(i) cause an adverse reaction to the enrollee;

(ii) decrease the ability of the enrollee to achieve or maintain reasonable functional
ability in performing daily activities; or

(iii) cause physical or mental harm to the enrollee;

(2) the enrollee has had a trial of the required prescription drug covered by their current
or previous health plan, or another prescription drug in the same pharmacologic class or
with the same mechanism of action, and was adherent during such trial for a period of time
sufficient to allow for a positive treatment outcome, and the prescription drug was
discontinued by the enrollee's health care provider due to lack of effectiveness, or an adverse
event. This clause does not prohibit a health plan company from requiring an enrollee to
try another drug in the same pharmacologic class or with the same mechanism of action if
that therapy sequence is supported by the evidence-based and peer-reviewed clinical practice
guideline, Food and Drug Administration label, or pharmaceutical manufacturer's prescribing
information; or

(3) the enrollee is currently receiving a positive therapeutic outcome on a prescription
drug for the medical condition under consideration if, while on their current health plan or
the immediately preceding health plan, the enrollee received coverage for the prescription
drug and the enrollee's prescribing health care provider gives documentation to the health
plan company that the change in prescription drug required by the step therapy protocol is
expected to be ineffective or cause harm to the enrollee based on the known characteristics
of the specific enrollee and the known characteristics of the required prescription drug.

(b) Upon granting a step therapy override, a health plan company shall authorize coverage
for the prescription drug if the prescription drug is a covered prescription drug under the
enrollee's health plan.

(c) The enrollee, or the prescribing health care provider if designated by the enrollee,
may appeal the denial of a step therapy override by a health plan company using the
complaint procedure under sections 62Q.68 to 62Q.73.

(d) In a denial of an override request and any subsequent appeal, a health plan company's
decision must specifically state why the step therapy override request did not meet the
condition under paragraph (a) cited by the prescribing health care provider in requesting
the step therapy override and information regarding the procedure to request external review
of the denial pursuant to section 62Q.73. A denial of a request for a step therapy override
that is upheld on appeal is a final adverse determination for purposes of section 62Q.73 and
is eligible for a request for external review by an enrollee pursuant to section 62Q.73.

(e) A health plan company shall respond to a step therapy override request or an appeal
within five days of receipt of a complete request. In cases where exigent circumstances
exist, a health plan company shall respond within 72 hours of receipt of a complete request.
If a health plan company does not send a response to the enrollee or prescribing health care
provider if designated by the enrollee within the time allotted, the override request or appeal
is granted and binding on the health plan company.

(f) Step therapy override requests must be accessible to and submitted by health care
providers, and accepted by group purchasers electronically through secure electronic
transmission, as described under section 62J.497, subdivision 5.

(g) Nothing in this section prohibits a health plan company from:

(1) requesting relevant documentation from an enrollee's medical record in support of
a step therapy override request; or

(2) requiring an enrollee to try a generic equivalent drug pursuant to section 151.21, or
a biosimilar, as defined under United States Code, chapter 42, section 262(i)(2), prior to
providing coverage for the equivalent branded prescription drug.

(h) This section shall not be construed to allow the use of a pharmaceutical sample for
the primary purpose of meeting the requirements for a step therapy override.

EFFECTIVE DATE.

This section is effective January 1, 2019, and applies to health
plans offered, issued, or sold on or after that date.