,,ii #aaith ,,congress #ast ,session ,s4 #bijc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #ah 7legislative day1 ,september #af71 #bjbe,ms4 ,murkowski 7for herself1 ,ms4 ,hassan1 ,mr4 ,marshall1 ,ms4 ,rosen1 ,mr4 ,padilla1 ,mr4 ,hickenlooper1 ,mr4 ,merkley1 ,mr4 ,sullivan1 ,mr4 ,warnock1 ,mrs4 ,hyde-,smith1 ,ms4 ,cortez ,masto1 ,mr4 ,moran1 ,mr4 ,cramer1 ,mr4 ,kaine1 ,mr4 ,budd1 ,mrs4 ,shaheen1 ,mr4 ,booker1 ,mr4 ,wyden1 and ,mr4 ,coons7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,employee ,retirement ,income ,security ,act of #aigd 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 protocol1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,safe ,step ,act4 #b4 ,required exceptions process for medication step therapy protocols 7a7 ,required exceptions process for medication step therapy protocols ,the ,employee ,retirement ,income ,security ,act of #aigd is amended by inserting after section #gac of such ,act 7#bi ,u4,s4,c4 #aahe;b7 the following new section3 #gac;,a4 ,required exceptions process for medication step therapy protocols 7a7 ,in general ,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 protocol1 the plan or issuer shall-- 7#a7 implement a clear1 prompt1 and transparent process for a participant or beneficiary 7or the prescribing health care provider 7referred to in this section as the prescriber7 on behalf of the participant or beneficiary7 to request an exception to such medication step therapy protocol1 pursuant to subsection 7b72 and 7#b7 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 7b71 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 year4 7b7 ,circumstances for exception approval ,the circumstances requiring an exception to a medication step therapy protocol1 pursuant to a request under subsection 7a71 are any of the following3 7#a7 ,any treatments otherwise required under the protocol1 or treatments in the same pharmacological class or having the same mechanism of action1 including treatments provided prior to the effective date of the participant's or beneficiary's coverage under the plan or coverage1 have been ineffective in the treatment of the disease or condition of the participant or beneficiary1 when prescribed consistent with clinical indications1 clinical guidelines1 or other peer-reviewed evidence1 based on the prescribing health care professional's judgement or relevant information provided by the participant or beneficiary 7including the medical records of the participant or beneficiary74 7#b7 ,delay of effective treatment would lead to severe or irreversible consequences1 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 treatment4 7#c7 ,any treatments otherwise required under the protocol are contraindicated for the participant or beneficiary or have caused1 or are likely to cause1 based on clinical1 peer-reviewed evidence1 an adverse reaction or other physical or mental harm to the participant or beneficiary4 7#d7 ,any treatment otherwise required under the protocol has prevented1 will prevent1 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 7as defined in section #dda4eje of title #db1 ,code of ,federal ,regulations 7or successor regulations774 7#e7 ,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 plan4 7#f7 ,other circumstances1 as determined by the ,secretary4 7c7 ,requirement of a clear process 7#a7 ,in general ,the process required by subsection 7a7 shall-- 7,a7 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 exception2 7,b7 develop and use a standard form and instructions for the request of an exception under subsection 7b71 available in paper and electronic forms1 and allow for submission of such form by paper and electronic means2 7,c7 provide both paper and electronic means for the submission of requests for additional information2 7,d7 clearly set forth all required information and the specific criteria that will be used to determine whether an exception is warranted1 which may require disclosure of-- 7i7 the medical history or other health records of the participant or beneficiary demonstrating that the participant or beneficiary seeking an exception-- 7,i7 has tried other drugs included in the drug therapy class without success2 or 7,,ii7 has taken the requested drug for a clinically appropriate amount of time to establish stability1 in relation to the condition being treated and prescription guidelines given by the prescribing physician2 or 7ii7 other clinical information that may be relevant to conducting the exception review2 7,e7 not require the submission of any information or supporting documentation beyond what is strictly necessary 7as determined by the ,secretary7 to determine whether a circumstance listed in subsection 7b7 exists2 7,f7 clearly outline conditions under which an exception request warrants expedited resolution from the group health plan or health insurance issuer1 pursuant to subsection 7d77#b72 and 7,g7 allow a representative of a participant or beneficiary1 which may include a designated third-party advocate1 to act on behalf of the participant or beneficiary4 7#b7 ,availability of process information ,the group health plan or health insurance issuer shall make information regarding the process required under subsection 7a7 readily available in the relevant plan materials1 including the summary of benefits and1 if available1 on the website of the group health plan or health insurance issuer4 ,such information shall include-- 7,a7 the requirements for requesting an exception to a medication step therapy protocol pursuant to this section2 and 7,b7 any forms1 supporting information1 and contact information1 as appropriate4 7d7 ,timing for determination of exception ,the process required under subsection 7a77#a7 shall provide for the disposition of requests received under such paragraph in accordance with the following3 7#a7 ,subject to paragraph 7#b71 not later than #gb hours after receiving an initial exception request1 the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 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 7b7 are met4 ,the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 with a determination of exception eligibility no later than #gb hours after receipt of the additional required information4 7#b7 ,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 beneficiary1 may jeopardize the ability of the participant or beneficiary to regain maximum function1 or may subject the participant or beneficiary to severe pain that cannot be adequately managed without the treatment that is the subject of the request1 the plan or issuer shall conduct a review of the request and respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 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 7b7 are met1 in accordance with the following3 7,a7 ,if the plan or issuer can make a determination of exception eligibility without additional information1 such determination shall be made on an expedited basis1 and no later than #bd hours after receipt of such request4 7,b7 ,if the plan or issuer requires additional information before making a determination of exception eligibility1 the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 with a request for such information within #bd hours of the request for a determination1 and shall respond with a determination of exception eligibility as quickly as the condition or disease requires1 and no later than #bd hours after receipt of the additional required information4 7e7 ,duration of a grant ,if an exception to a medication step therapy protocol is granted under this section to a participant or beneficiary1 coverage for the requested drug shall remain in effect with respect to such participant or beneficiary for not less than one year4 7f7 ,medication step therapy protocol ,in this section1 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 prescribed4 7g7 ,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 7f71 regardless of whether such policy is described by such group health plan or health insurance coverage as a step therapy protocol4 7h7 ,reporting 7#a7 ,reporting to the ,secretary ,not later than #c years after the date of enactment of the ,safe ,step ,act and not later than ,october #a of each year thereafter1 each group health plan and health insurance issuer offering group health insurance coverage shall report to the ,secretary1 in such manner as the ,secretary shall require1 the following3 7,a7 ,the number of step therapy exception requests received for each exception circumstance described in paragraphs 7#a7 through 7#f7 of subsection 7b71 and the numbers of such requests for each such circumstance that were-- 7i7 approved2 7ii7 denied1 and the reasons for the denials2 7iii7 initially denied and appealed2 and 7iv7 initially denied and then subsequently reversed by internal appeals or external reviews4 7,b7 ,the number of times a plan or issuer requested additional information in response to a step therapy exception request1 by exception circumstance described in paragraphs 7#a7 through 7#f7 of subsection 7b74 7,c7 ,the number of exception requests submitted by participants or beneficiaries1 and the number of exception requests submitted by prescribers1 by medical specialty4 7,d7 ,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 by1 or physical or mental harm to1 the participant or beneficiary1 as described in subsection 7b77#c74 7,e7 ,the entities responsible for providing pharmacy benefit management services for the group health plan or health insurance coverage4 7#b7 ,information ,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 7#a74 7#c7 ,reports to ,congress ,not later than #c years after the date of enactment of the ,safe ,step ,act1 and not later than ,october #a of each year thereafter1 the ,secretary shall submit to ,congress1 and make publicly available1 a report that contains a summary and analysis of the information reported under paragraph 7#a71 including an analysis of1 with respect to requests for exceptions under this section1 approvals1 and denials1 including the reasons for denials2 appeals and external reviews2 and trends1 if any1 in exception requests by medical specialty or medical condition4 4 7b7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is amended by inserting after the item relating to section #gac the following new item3 ,sec4 #gac;,a4 ,required exceptions process for medication step therapy protocols4 4 7c7 ,effective date 7#a7 ,in general ,the amendment made by subsection 7a7 applies with respect to plan years beginning with the first plan year that begins at least #f months after the date of the enactment of this ,act4 7#b7 ,regulations ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,labor shall issue final regulations1 through notice and comment rulemaking1 to implement the provisions of section #gac;,a of the ,employee ,retirement ,income ,security ,act of #aigd1 as added by subsection 7a74