Safe Step Act
This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer.
A request for such an exception to the protocol must be granted if (1) an otherwise required treatment has been ineffective, (2) such treatment is expected to be ineffective and delaying effective treatment would lead to irreversible consequences, (3) such treatment will cause or is likely to cause an adverse reaction to the individual, (4) such treatment is expected to prevent the individual from performing daily activities or occupational responsibilities, (5) the individual is stable based on the prescription drugs already selected, or (6) there are other circumstances as determined by the Employee Benefits Security Administration.
The bill requires a group health plan to implement and make readily available a clear process for an individual to request an exception to the protocol, including required information and criteria for granting an exception. The bill further specifies timelines under which plans must respond to such requests.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2163 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 2163
To amend the Employee Retirement Income Security Act of 1974 to require
a group health plan or health insurance coverage offered in connection
with such a plan to provide an exceptions process for any medication
step therapy protocol, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 23, 2021
Mr. Ruiz (for himself, Mr. Wenstrup, Mrs. McBath, and Mrs. Miller-
Meeks) introduced the following bill; which was referred to the
Committee on Education and Labor
_______________________________________________________________________
A BILL
To amend the Employee Retirement Income Security Act of 1974 to require
a group health plan or health insurance coverage offered in connection
with such a plan to provide an exceptions process for any medication
step therapy protocol, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Safe Step Act''.
SEC. 2. REQUIRED EXCEPTIONS PROCESS FOR MEDICATION STEP THERAPY
PROTOCOLS.
(a) In General.--The Employee Retirement Income Security Act of
1974 is amended by inserting after section 725 of such Act (29 U.S.C.
1185d) the following new section:
``SEC. 726. REQUIRED EXCEPTIONS PROCESS FOR MEDICATION STEP THERAPY
PROTOCOLS.
``(a) In General.--In the case of a group health plan or health
insurance coverage offered in connection with such a plan that provides
coverage of a prescription drug pursuant to a medication step therapy
protocol, the plan or coverage shall--
``(1) implement a clear and transparent process for a
participant or beneficiary (or the prescribing health care
provider on behalf of the participant or beneficiary) to
request an exception to such medication step therapy protocol,
pursuant to subsection (b); and
``(2) where the participant or beneficiary or prescribing
health care provider's request for an exception to the
medication step therapy protocols satisfies the criteria and
requirements of subsection (b), cover the requested drug in
accordance with the terms established by the health plan or
coverage for patient cost-sharing rates or amounts at the time
of the participant's or beneficiary's enrollment in the health
plan or health insurance coverage.
``(b) Circumstances for Exception Approval.--The circumstances
requiring an exception to a medication step therapy protocol, pursuant
to a request under subsection (a), are any of the following:
``(1) Any treatments otherwise required under the protocol,
or treatments in the same pharmacological class or having the
same mechanism of action, have been ineffective in the
treatment of the disease or condition of the participant or
beneficiary, when prescribed consistent with clinical
indications, clinical guidelines, or other peer-reviewed
evidence.
``(2) Delay of effective treatment would lead to severe or
irreversible consequences, and the treatment otherwise required
under the protocol is reasonably expected to be ineffective
based upon the documented physical or mental characteristics of
the participant or beneficiary and the known characteristics of
such treatment.
``(3) Any treatments otherwise required under the protocol
are contraindicated for the participant or beneficiary or have
caused, or are likely to cause, based on clinical, peer-
reviewed evidence, an adverse reaction or other physical harm
to the participant or beneficiary.
``(4) Any treatment otherwise required under the protocol
has prevented, will prevent, or is likely to prevent a
participant or beneficiary from achieving or maintaining
reasonable and safe functional ability in performing
occupational responsibilities or activities of daily living (as
defined in section 441.505 of title 42, Code of Federal
Regulations (or successor regulations)).
``(5) The participant or beneficiary is stable for his or
her disease or condition on the prescription drug or drugs
selected by the prescribing health care provider and has
previously received approval for coverage of the relevant drug
or drugs for the disease or condition by any group health plan
or health insurance issuer.
``(6) Other circumstances, as determined by the Secretary.
``(c) Requirement of a Clear Process.--
``(1) In general.--The process required by subsection (a)--
``(A) shall provide the prescribing health care
provider or beneficiary or designated third-party
advocate an opportunity to present such provider's
clinical rationale and relevant medical information for
the group health plan or health insurance issuer to
evaluate such request for exception;
``(B) shall clearly set forth all required
information and the specific criteria that will be used
to determine whether an exception is warranted, which
may require disclosure of--
``(i) the medical history or other health
records of the participant or beneficiary
demonstrating that the participant or
beneficiary seeking an exception--
``(I) has tried other drugs
included in the drug therapy class
without success; or
``(II) has taken the requested drug
for a clinically appropriate amount of
time to establish stability, in
relation to the condition being treated
and prescription guidelines given by
the prescribing physician; or
``(ii) other clinical information that may
be relevant to conducting the exception review;
``(C) may not require the submission of any
information or supporting documentation beyond what is
strictly necessary to determine whether any of the
circumstances listed in subsection (b) exists; and
``(D) shall clearly outline conditions under which
an exception request warrants expedited resolution from
the group health plan or health insurance issuer,
pursuant to subsection (d)(2).
``(2) Availability of process information.--The group
health plan or health insurance issuer shall make information
regarding the process required under subsection (a) readily
available on the internet website of the group health plan or
health insurance issuer. Such information shall include--
``(A) the requirements for requesting an exception
to a medication step therapy protocol pursuant to this
section; and
``(B) any forms, supporting information, and
contact information, as appropriate.
``(d) Timing for Determination of Exception.--The process required
under subsection (a)(1) shall provide for the disposition of requests
received under such paragraph in accordance with the following:
``(1) Subject to paragraph (2), not later than 72 hours
after receiving an initial exception request, the plan or
issuer shall respond to the requesting prescriber with either a
determination of exception eligibility or a request for
additional required information strictly necessary to make a
determination of whether the conditions specified in subsection
(b) are met. The plan or issuer shall respond to the requesting
provider with a determination of exception eligibility no later
than 72 hours after receipt of the additional required
information.
``(2) In the case of a request under circumstances in which
the applicable medication step therapy protocol may seriously
jeopardize the life or health of the participant or
beneficiary, the plan or issuer shall conduct a review of the
request and respond to the requesting prescriber with either a
determination of exception eligibility or a request for
additional required information strictly necessary to make a
determination of whether the conditions specified in subsection
(b) are met, in accordance with the following:
``(A) If the plan or issuer can make a
determination of exception eligibility without
additional information, such determination shall be
made on an expedited basis, and no later than 24 hours
after receipt of such request.
``(B) If the plan or issuer requires additional
information before making a determination of exception
eligibility, the plan or issuer shall respond to the
requesting provider with a request for such information
within 24 hours of the request for a determination, and
shall respond with a determination of exception
eligibility as quickly as the condition or disease
requires, and no later than 24 hours after receipt of
the additional required information.
``(e) Medication Step Therapy Protocol.--In this section, the term
`medication step therapy protocol' means a drug therapy utilization
management protocol or program under which a group health plan or
health insurance issuer offering group health insurance coverage of
prescription drugs requires a participant or beneficiary to try an
alternative preferred, prescription drug or drugs before the plan or
health insurance issuer approves coverage for the non-preferred drug
therapy prescribed.
``(f) Clarification.--This section shall apply with respect to any
group health plan or health insurance coverage offered in connection
with such a plan that provides coverage of a prescription drug pursuant
to a policy that meets the definition of the term `medication step
therapy protocol' in subsection (e), regardless of whether such policy
is described by such group health plan or health insurance coverage as
a step therapy protocol.''.
(b) Clerical Amendment.--The table of contents in section 1 of the
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et
seq.) is amended by inserting after the item relating to section 725
the following new items:
``Sec. 726. Required exceptions process for medication step therapy
protocols.''.
(c) Effective Date.--
(1) In general.--The amendment made by subsection (a)
applies with respect to plan years beginning with the first
plan year that begins at least 6 months after the date of the
enactment of this Act.
(2) Regulations.--Not later than 6 months after the date of
the enactment of this Act, the Secretary of Labor shall issue
final regulations, through notice and comment rulemaking, to
implement the provisions of section 726 of the Employee
Retirement Income Security Act of 1974, as added by subsection
(a).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Education and Labor.
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