HR 5509
Safe Step Act
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Bill overview
The Safe Step Act amends the Employee Retirement Income Security Act (ERISA) to require group health plans and health insurance coverage to establish a clear process for participants or beneficiaries to request an exception to medication step therapy protocols. This process must be prompt, transparent, and allow for the presentation of clinical information. The bill also outlines specific circumstances under which an exception can be granted, such as ineffective treatments, potential severe consequences, contraindications, or functional ability impacts, and sets timelines for responses and expedited reviews in critical cases.
Key provisions
- Requires group health plans and insurers to implement a process for medication step therapy exception requests.
- Specifies circumstances for exception approval, including treatment ineffectiveness, potential harm, and functional ability impacts.
- Mandates a clear, prompt, and transparent exception request process with defined timelines for responses.
- Requires plans to provide information about the exception process to participants and beneficiaries.
- Establishes a one-year duration for granted exceptions.
- Defines ‘medication step therapy protocol’ for the purpose of the bill.
- Requires reporting of exception requests and outcomes to the Secretary of Labor.
- Sets a timeframe for the Department of Labor to issue implementing regulations.
Who is affected
- Individuals with health insurance coverage
- Group health plans
- Health insurance issuers
- Prescribers
- Pharmacy Benefit Managers
Sponsors
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Primary sponsor
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119th CONGRESS — 1st Session
H. R. 5509
IN THE HOUSE OF REPRESENTATIVES
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.
This Act may be cited as the Safe Step Act
.
The Employee Retirement Income Security Act of 1974 is amended by inserting after section 713 of such Act (29 U.S.C. 1185b) the following new section:
In the case of a group health plan or health insurance issuer offering 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 issuer shall—
implement a clear, prompt, and transparent process for a participant or beneficiary (or the prescribing health care provider (referred to in this section as the prescriber
) on behalf of the participant or beneficiary) to request an exception to such medication step therapy protocol, pursuant to subsection (b); and
where the participant or beneficiary or prescriber'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 plan or coverage for patient cost-sharing rates or amounts at the beginning of the plan year.
The circumstances requiring an exception to a medication step therapy protocol, pursuant to a request under subsection (a), are any of the following:
Any treatments otherwise required under the protocol, or treatments in the same pharmacological class or having the same mechanism of action, including treatments provided prior to the effective date of the participant's or beneficiary's coverage under the plan or coverage, 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, based on the prescribing health care professional’s judgement or relevant information provided by the participant or beneficiary (including the medical records of the participant or beneficiary).
Delay of effective treatment would lead to severe or irreversible consequences, or worsen disease progression or a comorbidity and the treatment otherwise required under the protocol is reasonably expected by the prescriber to be ineffective based upon the documented physical or mental characteristics of the participant or beneficiary and the known characteristics of such treatment.
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 or mental harm to the participant or beneficiary.
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)).
The participant or beneficiary is stable for his or her disease or condition on the prescription drug or drugs selected by the prescriber and has previously received approval for coverage of the relevant drug or drugs for the disease or condition by any public or private health plan.
Other circumstances, as determined by the Secretary.
The process required by subsection (a) shall—
provide the prescriber or participant or beneficiary an opportunity to present such prescriber’s clinical rationale and relevant medical information for the group health plan or health insurance issuer to evaluate such request for exception;
develop and use a standard form and instructions for the request of an exception under subsection (b), available in paper and electronic forms, and allow for submission of such form by paper and electronic means;
the medical history or other health records of the participant or beneficiary demonstrating that the participant or beneficiary seeking an exception—
has tried other drugs included in the drug therapy class without success; or
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
other clinical information that may be relevant to conducting the exception review;
not require the submission of any information or supporting documentation beyond what is strictly necessary (as determined by the Secretary) to determine whether a circumstance listed in subsection (b) exists;
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); and
allow a representative of a participant or beneficiary, which may include a designated third-party advocate, to act on behalf of the participant or beneficiary.
The group health plan or health insurance issuer shall make information regarding the process required under subsection (a) readily available in the relevant plan materials, including the summary of benefits and, if available, on the website of the group health plan or health insurance issuer. Such information shall include—
the requirements for requesting an exception to a medication step therapy protocol pursuant to this section; and
any forms, supporting information, and contact information, as appropriate.
The process required under subsection (a)(1) shall provide for the disposition of requests received under such paragraph in accordance with the following:
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, may jeopardize the ability of the participant or beneficiary to regain maximum function, or may subject the participant or beneficiary to severe pain that cannot be adequately managed without the treatment that is the subject of the request, the plan or issuer shall conduct a review of the request and respond to the participant or beneficiary and, if applicable, 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:
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.
If the plan or issuer requires additional information before making a determination of exception eligibility, the plan or issuer shall respond to the participant or beneficiary and, if applicable, the requesting prescriber, 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.
If an exception to a medication step therapy protocol is granted under this section to a participant or beneficiary, coverage for the requested drug shall remain in effect with respect to such participant or beneficiary for not less than one year.
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.
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 (f), regardless of whether such policy is described by such group health plan or health insurance coverage as a step therapy protocol.
Safe Step Act
and not later than October 1 of each year thereafter, each group health plan and health insurance issuer offering group health insurance coverage shall report to the Secretary, in such manner as the Secretary shall require, the following:The number of times a plan or issuer requested additional information in response to a step therapy exception request, by exception circumstance described in paragraphs (1) through (6) of subsection (b).
The number of exception requests submitted by participants or beneficiaries, and the number of exception requests submitted by prescribers, by medical specialty.
The medical conditions for which participants and beneficiaries were granted exceptions due to the likelihood that switching from a prescription drug will likely cause an adverse reaction by, or physical or mental harm to, the participant or beneficiary, as described in subsection (b)(3).
The entities responsible for providing pharmacy benefit management services for the group health plan or health insurance coverage.
A group health plan or health insurance issuer offering group health insurance coverage shall not enter into a contract with a third-party administrator or an entity providing pharmacy benefit management services on behalf of the plan or coverage that prevents the plan or issuer from obtaining from the third-party administrator or the entity providing pharmacy benefit management services any information needed for the plan or issuer to comply with the reporting requirements under paragraph (1).
Not later than 3 years after the date of enactment of the
Safe Step Act
, and not later than October 1 of each year thereafter, the Secretary shall submit to Congress, and make publicly available, a report that contains a summary and analysis of the information reported under paragraph (1), including an analysis of, with respect to requests for exceptions under this section, approvals, and denials, including the reasons for denials; appeals and external reviews; and trends, if any, in exception requests by medical specialty or medical condition.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 713 the following new item:
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.
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 713A of the Employee Retirement Income Security Act of 1974, as added by subsection (a).