Bill Summary
This legislation, also known as the "Safe Step Act," aims to amend the Employee Retirement Income Security Act of 1974 by adding a new section that requires group health plans (or health insurance coverage offered in connection with such a plan) to provide an exceptions process for any medication step therapy protocols. This means that if a patient or their prescribing healthcare provider believes that following a certain sequence of prescription drugs, known as a medication step therapy protocol, would not be in the best interest of the patient, they can request an exception to the protocol. The process for requesting an exception must be clear and readily available, and the plan cannot require unnecessary information or documentation. The decision to grant an exception must be made in a timely manner, with expedited options for cases where the protocol could seriously jeopardize the life, health, or ability of the patient. This legislation also clarifies that it applies to any group health plan that covers prescription drugs under a medication step therapy protocol, regardless of how it is labeled. It will take effect 6 months after being enacted, with final regulations to be issued by the Secretary of Labor within 9 months.
Possible Impacts
1. A person with a chronic illness that requires a specific medication may have difficulty accessing it under their group health plan's medication step therapy protocol. This could result in delays or denial of coverage, leading to higher out-of-pocket costs for the medication or even potentially harmful effects on their health.
2. A patient may have to go through a lengthy and complicated process to request an exception to a medication step therapy protocol, which could be overwhelming and time-consuming for the patient and their healthcare provider. This could affect their ability to adhere to their treatment plan and potentially cause adverse health effects.
3. The legislation may lead to increased administrative and regulatory burdens for group health plans and healthcare providers, as they must now implement and adhere to an exceptions process for medication step therapy protocols. This could result in higher costs for these entities, which could potentially be passed on to patients through higher premiums or deductibles.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2279 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 2279
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
April 10, 2019
Mr. Ruiz (for himself and Mr. Wenstrup) 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 715 of such Act (29 U.S.C.
1185d) the following new section:
``SEC. 716. 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 process for a participant or
beneficiary (or the prescribing health care provider) to
request an exception to such medication step therapy protocol;
and
``(2) if such a request demonstrates (through supporting
documentation, if necessary) that any of the circumstances
listed in subsection (b) exists, authorize coverage for the
prescription drug without regard to such medication step
therapy protocol.
``(b) Expedited Approval.--The circumstances warranting an
exception to a medication step therapy protocol, pursuant to a request
under subsection (a), are any of the following:
``(1) The treatment otherwise required under the protocol,
or a drug or drugs in the same pharmacological class or having
the same mechanism of action, are contraindicated or have been
ineffective in the treatment of the disease or condition of the
participant or beneficiary.
``(2) The treatment otherwise required under the protocol
is reasonably expected to be ineffective based upon--
``(A) the known physical or mental characteristics
of the participant or beneficiary, including medical
history; and
``(B) the known characteristics of such treatment.
``(3) The treatment otherwise required under the protocol
will cause or is likely to cause an adverse reaction or other
physical harm to the participant or beneficiary.
``(4) The treatment otherwise required under the protocol
is not in the best interest of the participant or beneficiary,
based on medical necessity, because the participant or
beneficiary's use of such treatment is expected to decrease the
participant or beneficiary's ability--
``(A) to achieve or maintain reasonable and safe
functional ability in performing daily activities or
occupational responsibilities; or
``(B) to adhere to the treatment plan as defined by
the prescribing health care provider.
``(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.
``(c) Clear Process.--The process required by subsection (a)(1)--
``(1) shall make information regarding such process readily
available on the website of the group health plan, including--
``(A) the requirements for requesting an exception
to a medication step therapy protocol pursuant to this
section; and
``(B) any necessary forms, supporting information,
and contact information; and
``(2) 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.
``(d) Timing for Granting Exception.--The process required by
subsection (a)(1) shall provide for the disposition of requests
received under such paragraph in accordance with the following:
``(1) Such a request shall be granted as quickly as the
disease or condition of the participant or beneficiary
requires, but no later than 3 days after the day of receipt of
the request.
``(2) For circumstances in which the applicable medication
step therapy protocol may seriously jeopardize the life,
health, or ability to regain maximum function of the
participant or beneficiary, such a request shall be granted--
``(A) on an expedited basis; and
``(B) no later than 24 hours after receipt of such
request.
``(e) Medication Step Therapy Protocol.--In this section, the term
`medication step therapy protocol' means a protocol or program that
establishes a specific sequence in which prescription drugs that--
``(1) are for a specified disease or condition; and
``(2) are medically necessary for a particular patient,
are covered under a pharmacy or medical benefit by a group health plan
or a health insurance issuer offering group or individual health
insurance coverage.
``(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) Technical Correction; Clerical Change.--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 714 the following new items:
``Sec. 715. Additional market reforms.
``Sec. 716. Required exceptions process for medication step therapy
protocols.''.
(c) Effective Date.--
(1) In general.--The amendment made by subsection (a)
applies to plan years beginning no sooner than 6 months after
the date of the enactment of this Act.
(2) Regulations.--Not later than the date that is 9 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 716 of the
Employee Retirement Income Security Act of 1974, as added by
subsection (a).
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