What This Bill Does
This bill requires health insurance plans offered through employers to create a process that allows patients or their doctors to request an exception when the insurance company says a patient must try a different medication first. The bill sets specific reasons when insurance companies must approve these exception requests and establishes timelines for making decisions.
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Who It Affects
- Employees with group health insurance plans through their employers
- Doctors who prescribe medications to these employees
- Employers who offer health insurance
- Health insurance companies offering group health insurance
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Key Provisions
- Health plans must have a clear process for patients or their doctors to request exceptions to medication step therapy protocols (a practice where insurance requires trying cheaper drugs first) (Sec. 2(a))
- Plans must approve exceptions when prior medications in the same drug class have failed, when delaying treatment could cause serious harm, when required medications cause dangerous side effects, when required medications prevent someone from working or doing daily activities, or when a patient is stable on a different drug they've previously been approved for (Sec. 2(b))
- Health plans must respond to exception requests within 72 hours with either approval or a request for more information, and must respond again within 72 hours after receiving that information (Sec. 2(d)(1))
- In emergency situations where the medication step therapy protocol could seriously harm the patient's health, plans must respond within 24 hours (Sec. 2(d)(2))
- Plans must post information about how to request exceptions on their websites, including required forms and contact information (Sec. 2(c)(2))
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What Changes
If this becomes law, health insurance plans will be required to have formal exception processes they did not previously need to have. Insurance companies will have strict time limits for responding to requests and cannot ask for unnecessary paperwork. Patients will have legal rights to bypass the "try this drug first" requirement in specific medical situations.
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Important Definitions
**Medication step therapy protocol:** A policy where a health insurance company requires a patient to try a cheaper or preferred drug first before approving coverage for the drug the doctor actually prescribed (Sec. 2(e))
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Effective Date
The bill applies to health plan years beginning at least 6 months after the bill becomes law. The Secretary of Labor must issue final regulations within 6 months of the bill becoming law (Sec. 2(c))
I
118TH CONGRESS
1ST SESSION H. R. 2630
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 13, 2023
Mr. WENSTRUP (for himself, Mr. RUIZ, Mrs. MILLER-MEEKS, Mrs. MCBATH,
Mrs. CHAVEZ-DEREMER, and Mr. BLUMENAUER) introduced the fol-
lowing bill; which was referred to the Committee on Education and the
Workforce
A BILL
To amend the Employee Retirement Income Security Act
of 1974 to require a group health plan or health insur-
ance 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 Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Safe Step Act’’.
4
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SEC. 2. REQUIRED EXCEPTIONS PROCESS FOR MEDICA-
1
TION STEP THERAPY PROTOCOLS.
2
(a) IN GENERAL.—The Employee Retirement Income
3
Security Act of 1974 is amended by inserting after section
4
725 of such Act (29 U.S.C. 1185d) the following new sec-
5
tion:
6
‘‘SEC. 726. REQUIRED EXCEPTIONS PROCESS FOR MEDICA-
7
TION STEP THERAPY PROTOCOLS.
8
‘‘(a) IN GENERAL.—In the case of a group health
9
plan or health insurance coverage offered in connection
10
with such a plan that provides coverage of a prescription
11
drug pursuant to a medication step therapy protocol, the
12
plan or coverage shall—
13
‘‘(1) implement a clear and transparent process
14
for a participant or beneficiary (or the prescribing
15
health care provider on behalf of the participant or
16
beneficiary) to request an exception to such medica-
17
tion step therapy protocol, pursuant to subsection
18
(b); and
19
‘‘(2) where the participant or beneficiary or
20
prescribing health care provider’s request for an ex-
21
ception to the medication step therapy protocols sat-
22
isfies the criteria and requirements of subsection (b),
23
cover the requested drug in accordance with the
24
terms established by the health plan or coverage for
25
patient cost-sharing rates or amounts at the time of
26
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•HR 2630 IH
the participant’s or beneficiary’s enrollment in the
1
health plan or health insurance coverage.
2
‘‘(b) CIRCUMSTANCES FOR EXCEPTION APPROVAL.—
3
The circumstances requiring an exception to a medication
4
step therapy protocol, pursuant to a request under sub-
5
section (a), are any of the following:
6
‘‘(1) Any treatments otherwise required under
7
the protocol, or treatments in the same pharma-
8
cological class or having the same mechanism of ac-
9
tion, have been ineffective in the treatment of the
10
disease or condition of the participant or beneficiary,
11
when prescribed consistent with clinical indications,
12
clinical guidelines, or other peer-reviewed evidence.
13
‘‘(2) Delay of effective treatment would lead to
14
severe or irreversible consequences, and the treat-
15
ment otherwise required under the protocol is rea-
16
sonably expected to be ineffective based upon the
17
documented physical or mental characteristics of the
18
participant or beneficiary and the known character-
19
istics of such treatment.
20
‘‘(3) Any treatments otherwise required under
21
the protocol are contraindicated for the participant
22
or beneficiary or have caused, or are likely to cause,
23
based on clinical, peer-reviewed evidence, an adverse
24
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•HR 2630 IH
reaction or other physical harm to the participant or
1
beneficiary.
2
‘‘(4) Any treatment otherwise required under
3
the protocol has prevented, will prevent, or is likely
4
to prevent a participant or beneficiary from achiev-
5
ing or maintaining reasonable and safe functional
6
ability in performing occupational responsibilities or
7
activities of daily living (as defined in section
8
441.505 of title 42, Code of Federal Regulations (or
9
successor regulations)).
10
‘‘(5) The participant or beneficiary is stable for
11
his or her disease or condition on the prescription
12
drug or drugs selected by the prescribing health care
13
provider and has previously received approval for
14
coverage of the relevant drug or drugs for the dis-
15
ease or condition by any group health plan or health
16
insurance issuer.
17
‘‘(6) Other circumstances, as determined by the
18
Secretary.
19
‘‘(c) REQUIREMENT OF A CLEAR PROCESS.—
20
‘‘(1) IN
GENERAL.—The process required by
21
subsection (a)—
22
‘‘(A) shall provide the prescribing health
23
care provider or beneficiary or designated third-
24
party advocate an opportunity to present such
25
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•HR 2630 IH
provider’s clinical rationale and relevant med-
1
ical information for the group health plan or
2
health insurance issuer to evaluate such request
3
for exception;
4
‘‘(B) shall clearly set forth all required in-
5
formation and the specific criteria that will be
6
used to determine whether an exception is war-
7
ranted, which may require disclosure of—
8
‘‘(i) the medical history or other
9
health records of the participant or bene-
10
ficiary demonstrating that the participant
11
or beneficiary seeking an exception—
12
‘‘(I) has tried other drugs in-
13
cluded in the drug therapy class with-
14
out success; or
15
‘‘(II) has taken the requested
16
drug for a clinically appropriate
17
amount of time to establish stability,
18
in relation to the condition being
19
treated and prescription guidelines
20
given by the prescribing physician; or
21
‘‘(ii) other clinical information that
22
may be relevant to conducting the excep-
23
tion review;
24
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•HR 2630 IH
‘‘(C) may not require the submission of
1
any information or supporting documentation
2
beyond what is strictly necessary to determine
3
whether any of the circumstances listed in sub-
4
section (b) exists; and
5
‘‘(D) shall clearly outline conditions under
6
which an exception request warrants expedited
7
resolution from the group health plan or health
8
insurance issuer, pursuant to subsection (d)(2).
9
‘‘(2) AVAILABILITY
OF
PROCESS
INFORMA-
10
TION.—The group health plan or health insurance
11
issuer shall make information regarding the process
12
required under subsection (a) readily available on
13
the internet website of the group health plan or
14
health insurance issuer. Such information shall in-
15
clude—
16
‘‘(A) the requirements for requesting an
17
exception to a medication step therapy protocol
18
pursuant to this section; and
19
‘‘(B) any forms, supporting information,
20
and contact information, as appropriate.
21
‘‘(d) TIMING
FOR
DETERMINATION
OF
EXCEP-
22
TION.—The process required under subsection (a)(1) shall
23
provide for the disposition of requests received under such
24
paragraph in accordance with the following:
25
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•HR 2630 IH
‘‘(1) Subject to paragraph (2), not later than
1
72 hours after receiving an initial exception request,
2
the plan or issuer shall respond to the requesting
3
prescriber with either a determination of exception
4
eligibility or a request for additional required infor-
5
mation strictly necessary to make a determination of
6
whether the conditions specified in subsection (b)
7
are met. The plan or issuer shall respond to the re-
8
questing provider with a determination of exception
9
eligibility no later than 72 hours after receipt of the
10
additional required information.
11
‘‘(2) In the case of a request under circum-
12
stances in which the applicable medication step ther-
13
apy protocol may seriously jeopardize the life or
14
health of the participant or beneficiary, the plan or
15
issuer shall conduct a review of the request and re-
16
spond to the requesting prescriber with either a de-
17
termination of exception eligibility or a request for
18
additional required information strictly necessary to
19
make a determination of whether the conditions
20
specified in subsection (b) are met, in accordance
21
with the following:
22
‘‘(A) If the plan or issuer can make a de-
23
termination of exception eligibility without addi-
24
tional information, such determination shall be
25
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•HR 2630 IH
made on an expedited basis, and no later than
1
24 hours after receipt of such request.
2
‘‘(B) If the plan or issuer requires addi-
3
tional information before making a determina-
4
tion of exception eligibility, the plan or issuer
5
shall respond to the requesting provider with a
6
request for such information within 24 hours of
7
the request for a determination, and shall re-
8
spond with a determination of exception eligi-
9
bility as quickly as the condition or disease re-
10
quires, and no later than 24 hours after receipt
11
of the additional required information.
12
‘‘(e) MEDICATION STEP THERAPY PROTOCOL.—In
13
this section, the term ‘medication step therapy protocol’
14
means a drug therapy utilization management protocol or
15
program under which a group health plan or health insur-
16
ance issuer offering group health insurance coverage of
17
prescription drugs requires a participant or beneficiary to
18
try an alternative preferred, prescription drug or drugs be-
19
fore the plan or health insurance issuer approves coverage
20
for the non-preferred drug therapy prescribed.
21
‘‘(f) CLARIFICATION.—This section shall apply with
22
respect to any group health plan or health insurance cov-
23
erage offered in connection with such a plan that provides
24
coverage of a prescription drug pursuant to a policy that
25
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•HR 2630 IH
meets the definition of the term ‘medication step therapy
1
protocol’ in subsection (e), regardless of whether such pol-
2
icy is described by such group health plan or health insur-
3
ance coverage as a step therapy protocol.’’.
4
(b) CLERICAL AMENDMENT.—The table of contents
5
in section 1 of the Employee Retirement Income Security
6
Act of 1974 (29 U.S.C. 1001 et seq.) is amended by in-
7
serting after the item relating to section 725 the following
8
new items:
9
‘‘Sec. 726. Required exceptions process for medication step therapy protocols.’’.
(c) EFFECTIVE DATE.—
10
(1) IN
GENERAL.—The amendment made by
11
subsection (a) applies with respect to plan years be-
12
ginning with the first plan year that begins at least
13
6 months after the date of the enactment of this
14
Act.
15
(2) REGULATIONS.—Not later than 6 months
16
after the date of the enactment of this Act, the Sec-
17
retary of Labor shall issue final regulations, through
18
notice and comment rulemaking, to implement the
19
provisions of section 726 of the Employee Retire-
20
ment Income Security Act of 1974, as added by sub-
21
section (a).
22
Æ
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