,i #aafth ,,congress #ast ,session ,h4 ,r4 #bbgi ,,in ,,the ,,house ,,of ,,representatives ,april #aj1 #bjai,mr4 ,ruiz 7for himself and ,mr4 ,wenstrup7 introduced the following bill2 which was referred to the ,committee on ,education and ,labor ,a ,,bill ,to amend the ,employee ,retirement ,income ,security ,act of #aigd to require a group health plan 7or health insurance coverage offered in connection with such a plan7 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 ,in general ,the ,employee ,retirement ,income ,security ,act of #aigd is amended by inserting after section #gae of such ,act 7#bi ,u4,s4,c4 #aahe;d7 the following new section3 #gaf4 ,required exceptions process for medication step therapy protocols 7a7 ,in general ,in the case of a group health plan 7or health insurance coverage offered in connection with such a plan7 that provides coverage of a prescription drug pursuant to a medication step therapy protocol1 the plan or coverage shall-- 7#a7 implement a clear process for a participant or beneficiary 7or the prescribing health care provider7 to request an exception to such medication step therapy protocol2 and 7#b7 if such a request demonstrates 7through supporting documentation1 if necessary7 that any of the circumstances listed in subsection 7b7 exists1 authorize coverage for the prescription drug without regard to such medication step therapy protocol4 7b7 ,expedited approval ,the circumstances warranting an exception to a medication step therapy protocol1 pursuant to a request under subsection 7a71 are any of the following3 7#a7 ,the treatment otherwise required under the protocol1 or a drug or drugs in the same pharmacological class or having the same mechanism of action1 are contraindicated or have been ineffective in the treatment of the disease or condition of the participant or beneficiary4 7#b7 ,the treatment otherwise required under the protocol is reasonably expected to be ineffective based upon-- 7,a7 the known physical or mental characteristics of the participant or beneficiary1 including medical history2 and 7,b7 the known characteristics of such treatment4 7#c7 ,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 beneficiary4 7#d7 ,the treatment otherwise required under the protocol is not in the best interest of the participant or beneficiary1 based on medical necessity1 because the participant or beneficiary's use of such treatment is expected to decrease the participant or beneficiary's ability-- 7,a7 to achieve or maintain reasonable and safe functional ability in performing daily activities or occupational responsibilities2 or 7,b7 to adhere to the treatment plan as defined by the prescribing health care provider4 7#e7 ,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 provider4 7c7 ,clear process ,the process required by subsection 7a77#a7-- 7#a7 shall make information regarding such process readily available on the website of the group health plan1 including-- 7,a7 the requirements for requesting an exception to a medication step therapy protocol pursuant to this section2 and 7,b7 any necessary forms1 supporting information1 and contact information2 and 7#b7 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 7b7 exists4 7d7 ,timing for granting exception ,the process required by subsection 7a77#a7 shall provide for the disposition of requests received under such paragraph in accordance with the following3 7#a7 ,such a request shall be granted as quickly as the disease or condition of the participant or beneficiary requires1 but no later than #c days after the day of receipt of the request4 7#b7 ,for circumstances in which the applicable medication step therapy protocol may seriously jeopardize the life1 health1 or ability to regain maximum function of the participant or beneficiary1 such a request shall be granted-- 7,a7 on an expedited basis2 and 7,b7 no later than #bd hours after receipt of such request4 7e7 ,medication step therapy protocol ,in this section1 the term medication step therapy protocol means a protocol or program that establishes a specific sequence in which prescription drugs that-- 7#a7 are for a specified disease or condition2 and 7#b7 are medically necessary for a particular patient1 are covered under a pharmacy or medical benefit by a group health plan or a health insurance issuer offering group or individual health insurance coverage4 7f7 ,clarification ,this section shall apply with respect to any group health plan 7or health insurance coverage offered in connection with such a plan7 that provides coverage of a prescription drug pursuant to a policy that meets the definition of the term medication step therapy protocol in subsection 7e71 regardless of whether such policy is described by such group health plan 7or health insurance coverage7 as a step therapy protocol4 4 7b7 ,technical correction2 clerical change ,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 #gad the following new items3 ,sec4 #gae4 ,additional market reforms4 ,sec4 #gaf4 ,required exceptions process for medication step therapy protocols4 4 7c7 ,effective date 7#a7 ,in general ,the amendment made by subsection 7a7 applies to plan years beginning no sooner than #f months after the date of the enactment of this ,act4 7#b7 ,regulations ,not later than the date that is #i 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 #gaf of the ,employee ,retirement ,income ,security ,act of #aigd1 as added by subsection 7a74