,i #aadth ,,congress #b;d ,session ,h4 ,r4 #dfig ,,in ,,the ,,house ,,of ,,representatives ,march #c1 #bjaf ,ms4 ,esty 7for herself1 ,mr4 ,costello of ,pennsylvania1 and ,mr4 ,knight7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means and the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to provide for increased ,federal oversight of prescription opioid treatment and assistance to ,states in reducing opioid addiction1 diversion1 and deaths4 #a4 ,short title ,this ,act may be cited as the ,prevent ,drug ,addiction ,act of #bjaf4 #b4 ,consumer education campaign ,part ,a of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq47 is amended by adding at the end the following3 #ejf;,c4 ,consumer education campaign 7a7 ,in general ,the ,administrator shall award grants to ,states and nonprofit entities for the purpose of conducting culturally sensitive consumer education about opioid addiction1 including methadone addiction4 ,such education shall include information on the dangers of opioid addiction1 how to prevent opioid addiction including through safe disposal of prescription medications and other safety precautions1 and detection of early warning signs of addiction4 7b7 ,eligibility ,to be eligible to receive a grant under subsection 7a71 an entity shall-- 7#a7 be a ,state or nonprofit entity2 and 7#b7 submit to the ,administrator an application at such time1 in such manner1 and containing such information as the ,administrator may require4 7c7 ,priority ,in awarding grants under this section1 the ,administrator shall give priority to applicants that are ,states or communities with a high incidence of addiction to methadone and other opioids1 and opioid-related deaths4 7d7 ,evaluations ,the ,administrator shall develop a process to evaluate the effectiveness of activities carried out by grantees under this section at reducing addiction to methadone and other opioids4 7e7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #ae1jjj1jjj for each of fiscal years #bjag through #bjba4 4 #c4 ,practitioner education 7a7 ,education requirements 7#a7 ,registration consideration ,section #cjc7;f7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;f77 is amended by inserting after paragraph 7#e7 the following3 7#f7 ,the applicant's compliance with the training requirements described in subsection 7g77#c7 during any previous period in which the applicant has been subject to such training requirements4 4 7#b7 ,training requirements ,section #cjc7;g7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77 is amended by adding at the end the following3 7#c7 7,a7 ,to be registered to prescribe or otherwise dispense methadone or other opioids1 a practitioner described in paragraph 7#a7 shall comply with the #ab-;hour training requirement of subparagraph 7,b7 at least once during each #c-year period4 7,b7 ,the training requirement of this subparagraph is that the practitioner has completed not less than #ab hours of training 7through classroom situations1 seminars at professional society meetings1 electronic communications1 or otherwise7 with respect to-- 7i7 the treatment and management of opioid-dependent patients2 7ii7 pain management treatment guidelines2 and 7iii7 early detection of opioid addiction1 including through such methods as ,screening1 ,brief ,intervention1 and ,referral to ,treatment 7,,sbirt71 that is provided by the ,american ,society of ,addiction ,medicine1 the ,american ,academy of ,addiction ,psychiatry1 the ,american ,medical ,association1 the ,american ,osteopathic ,association1 the ,american ,psychiatric ,association1 the ,american ,academy of ,pain ,management1 the ,american ,pain ,society1 the ,american ,academy of ,pain ,medicine1 the ,american ,board of ,pain ,medicine1 the ,american ,society of ,interventional ,pain ,physicians1 or any other organization that the ,secretary determines is appropriate for purposes of this subparagraph4 4 7b7 ,requirements for participation in opioid treatment programs ,effective ,july #a1 #bjag1 a physician practicing in an opioid treatment program shall comply with the requirements of section #cjc7;g77#c7 of the ,controlled ,substances ,act 7as added by subsection 7a77 with respect to required minimum training at least once during each #c-year period4 7c7 ,definition ,in this section1 the term opioid treatment program has the meaning given such term in section #h4b of title #db1 ,code of ,federal ,regulations 7or any successor regulation74 7d7 ,funding ,the ,drug ,enforcement ,administration shall fund the enforcement of the requirements specified in section #cjc7;g77#c7 of the ,controlled ,substances ,act 7as added by subsection 7a77 through the use of a portion of the licensing fees paid by controlled substance prescribers under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq474 #d4 ,operation of opioid treatment programs ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7i7 7#a7 ,an opioid treatment program that is registered under this section1 and that closes for business on any weekday or weekend day1 including a ,federal or ,state holiday1 shall comply with the requirements of this subsection4 7#b7 ,the program shall make acceptable arrangements for each patient who is restricted1 by ,federal regulation or guideline or by the determination of the program medical director1 from having a take-home dose of a controlled substance related to the treatment involved1 to receive a dose of that substance under appropriate supervision during the closure4 7#c7 ,the ,administrator of the ,substance ,abuse and ,mental ,health ,services ,administration shall issue a notice that references regulations on acceptable arrangements under this subsection1 or shall promulgate regulations on such acceptable arrangements4 4 #e4 ,mortality reporting ,part ,a of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq471 as amended by section #c1 is further amended by adding at the end the following3 #ejf;,d4 ,mortality reporting 7a7 ,model ,opioid ,treatment ,program ,mortality ,report 7#a7 ,in general ,not later than ,july #a1 #bjag1 the ,secretary1 acting through the ,administrator1 shall require that a ,model ,opioid ,treatment ,program ,mortality ,report be completed and submitted to the ,administrator for each individual who dies while receiving treatment in an opioid treatment program4 7#b7 ,requirement of ,states that receive funding for the ,controlled ,substance ,monitoring ,program ,as a condition for receiving funds under section #cii,o1 each ,state shall require that any individual who signs a death certificate where an opioid drug is detected in the body of the deceased1 or where such drug is otherwise associated with the death1 report such death to the ,administrator by submitting a ,model ,opioid ,treatment ,program ,mortality ,report described in paragraph 7#c74 ,such report shall be submitted to the ,administrator on or before the later of-- 7,a7 #ij days after the date of signing the death certificate2 or 7,b7 as soon as practicable after the date on which the necessary postmortem and toxicology reports become available to such individual1 as required by the ,secretary4 7#c7 ,development ,the ,administrator1 in consultation with ,state and local medical examiners1 prescribing physicians1 hospitals1 and any other organization that the ,administrator determines appropriate1 shall develop a ,model ,opioid ,treatment ,program ,mortality ,report to be used under paragraphs 7#a7 and 7#b74 7b7 ,national ,opioid ,death ,registry 7#a7 ,in general ,not later than ,july #a1 #bjag1 the ,administrator shall establish and implement1 through the ,national ,center for ,health ,statistics1 a ,national ,opioid ,death ,registry 7referred to in this subsection as the ,registry7 to track opioid-related deaths and information related to such deaths4 7#b7 ,consultation ,in establishing the uniform reporting criteria for the ,registry1 the ,director of the ,centers for ,disease ,control and ,prevention shall consult with the ,administrator1 ,state and local medical examiners1 prescribing physicians1 hospitals1 and any other organization that the ,director determines is appropriate for purposes of this subsection4 7#c7 ,requirements ,the registry shall be designed as a uniform reporting system for opioid-related deaths and shall require the reporting of information with respect to such deaths1 including-- 7,a7 the particular drug formulation used at the time of death2 7,b7 the dosage level2 7,c7 a description of the circumstances surrounding the death in relation to the recommended dosage involved2 7,d7 a disclosure of whether the medication involved can be traced back to a physician's prescription2 7,e7 a disclosure of whether the individual was in an opioid treatment program at the time of death2 7,f7 the age and sex of the individual2 and 7,g7 other nonpersonal information such as that included in filed ,national ,association of ,medical ,examiners ,pediatric ,toxicology ,registry case reports as required under the privacy standard for the de-identification of health information pursuant to the regulations contained in part #afd of title #de1 ,code of ,federal ,regulations4 7#d7 ,authorization ,there is authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjag through #bjba to carry out this subsection4 7c7 ,report on ,registry information ,not later than the ,january #a of the first fiscal year beginning #b years after the date of enactment of this section1 and each ,january #a thereafter1 the ,director of the ,centers for ,disease ,control and ,prevention shall submit to the ,secretary a report1 based on information contained in the ,registry described in subsection 7b71 concerning the number of methadone-related deaths in the ,united ,states for the year for which the report is submitted4 4 #f4 ,development of prescription drug addiction prevention and treatment quality measures across each relevant provider setting ,subpart ,i of part ,d of title ,,ix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#ca et seq47 is amended by adding at the end the following3 #icb4 ,development of prescription drug addiction prevention and treatment quality measures across each relevant provider setting 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,agency for ,healthcare ,research and ,quality and in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,administrator of the ,substance ,abuse and ,mental ,health ,services ,administration1 and the ,director of the ,centers for ,medicare ,medicaid ,services1 shall require the development and application of specific prescription drug addiction prevention and treatment quality measures for each relevant health care provider setting1 as identified by the ,director4 7b7 ,dissemination ,not later than ,april #a1 #bjag1 the ,secretary shall disseminate the quality measure requirements developed under subsection 7a7 to all affected providers4 7c7 ,types of measures ,quality measures developed under this section may be structure-oriented 7such as the required presence of a hospital-based treatment program71 process-oriented 7such as requiring patients to be informed of the addictive qualities of the medication being prescribed71 or outcome-oriented 7such as assessing family satisfaction with care74 4 #g4 ,programs to prevent prescription drug addiction under ,medicare part ,d 7a7 ,drug management program for at-,risk beneficiaries 7#a7 ,in general ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77 is amended by adding at the end the following3 7#d7 ,drug management program for at-risk beneficiaries 7,a7 ,authority to establish ,a ,,pdp sponsor may establish a drug management program for at-risk beneficiaries under which1 subject to subparagraph 7,b71 the ,,pdp sponsor may1 in the case of an at-risk beneficiary for prescription drug addiction who is an enrollee in a prescription drug plan of such ,,pdp sponsor1 limit such beneficiary's access to coverage for addictive drugs under such plan to addictive drugs that are prescribed for such beneficiary by a prescriber selected under subparagraph 7,d71 and dispensed for such beneficiary by a pharmacy selected under such subparagraph4 7,b7 ,requirement for notices 7i7 ,in general ,a ,,pdp sponsor may not limit the access of an at-risk beneficiary for prescription drug addiction to coverage for addictive drugs under a prescription drug plan until such sponsor-- 7,i7 provides to the beneficiary an initial notice described in clause 7ii7 and a second notice described in clause 7iii72 and 7,,ii7 verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription drug addiction4 7ii7 ,initial notice ,an initial notice described in this clause is a notice that provides to the beneficiary-- 7,i7 notice that the ,,pdp sponsor has identified the beneficiary as potentially being an at-risk beneficiary for prescription drug addiction2 7,,ii7 information describing all ,state and ,federal public health resources that are designed to address prescription drug addiction to which the beneficiary has access1 including mental health services and other counseling services2 7,,iii7 notice of1 and information about1 the right of the beneficiary to appeal such identification under subsection 7h7 and the option of an automatic escalation to external review2 7,,iv7 a request for the beneficiary to submit to the ,,pdp sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor to select under subparagraph 7,d7 in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug addiction as described in clause 7iii77,i72 7,v7 an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription drug addiction1 including an explanation of the drug management program established by the ,,pdp sponsor pursuant to subparagraph 7,a72 7,,vi7 clear instructions that explain how the beneficiary can contact the ,,pdp sponsor in order to submit to the ,,pdp sponsor the preferences described in subclause 7,,iv7 and any other communications relating to the drug management program for at-risk beneficiaries established by the ,,pdp sponsor2 and 7,,vii7 contact information for other organizations that can provide the beneficiary with assistance regarding such drug management program 7similar to the information provided by the ,secretary in other standardized notices provided to part ,d eligible individuals enrolled in prescription drug plans under this part74 7iii7 ,second notice ,a second notice described in this clause is a notice that provides to the beneficiary notice-- 7,i7 that the ,,pdp sponsor has identified the beneficiary as an at-risk beneficiary for prescription drug addiction2 7,,ii7 that such beneficiary is subject to the requirements of the drug management program for at-risk beneficiaries established by such ,,pdp sponsor for such plan2 7,,iii7 of the prescriber and pharmacy selected for such individual under subparagraph 7,d72 7,,iv7 of1 and information about1 the beneficiary's right to appeal such identification under subsection 7h7 and the option of an automatic escalation to external review2 7,v7 that the beneficiary can1 in the case that the beneficiary has not previously submitted to the ,,pdp sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor select under subparagraph 7,d71 submit such preferences to the ,,pdp sponsor2 and 7,,vi7 that includes clear instructions that explain how the beneficiary can contact the ,,pdp sponsor4 7iv7 ,timing of notices 7,i7 ,in general ,subject to subclause 7,,ii71 a second notice described in clause 7iii7 shall be provided to the beneficiary on a date that is not less than #fj days after an initial notice described in clause 7ii7 is provided to the beneficiary4 7,,ii7 ,exception ,in the case that the ,,pdp sponsor1 in conjunction with the ,secretary1 determines that concerns identified through rulemaking by the ,secretary regarding the health or safety of the beneficiary or regarding significant drug diversion activities require the ,,pdp sponsor to provide a second notice described in clause 7iii7 to the beneficiary on a date that is earlier than the date described in subclause 7,,ii71 the ,,pdp sponsor may provide such second notice on such earlier date4 7,c7 ,at-risk beneficiary for prescription drug addiction 7i7 ,in general ,for purposes of this paragraph1 the term at-risk beneficiary for prescription drug addiction means a part ,d eligible individual who is not an exempted individual described in clause 7ii7 and-- 7,i7 who is identified through the use of guidelines developed by the ,secretary in consultation with ,,pdp sponsors and other stakeholders described in section #aj7;f77#b77;,a7 of the ,prevent ,drug ,addiction ,act of #bjaf2 or 7,,ii7 with respect to whom the ,,pdp sponsor of a prescription drug plan1 upon enrolling such individual in such plan1 received notice from the ,secretary that such individual was identified under this paragraph to be an at-risk beneficiary for prescription drug addiction under the prescription drug plan in which such individual was most recently previously enrolled and such identification has not been terminated under subparagraph 7,f74 7ii7 ,exempted individual described ,an exempted individual described in this clause is an individual who-- 7,i7 receives hospice care under this title2 or 7,,ii7 the ,secretary elects to treat as an exempted individual for purposes of clause 7i74 7,d7 ,selection of prescribers 7i7 ,in general ,with respect to each at-risk beneficiary for prescription drug addiction enrolled in a prescription drug plan offered by such sponsor1 a ,,pdp sponsor shall1 based on the preferences submitted to the ,,pdp sponsor by the beneficiary pursuant to clauses 7ii77,,iv7 and 7iii77,v7 of subparagraph 7,b71 select-- 7,i7 one or more individuals who are authorized to prescribe addictive drugs 7referred to in this paragraph as prescribers7 who may write prescriptions for such drugs for such beneficiary2 and 7,,ii7 one or more pharmacies that may dispense such drugs to such beneficiary4 7ii7 ,reasonable access ,in making the selection under this subparagraph1 a ,,pdp sponsor shall ensure that the beneficiary continues to have reasonable access to drugs described in subparagraph 7,g71 taking into account geographic location1 beneficiary preference1 affordability1 and reasonable travel time4 7iii7 ,beneficiary preferences 7,i7 ,in general ,if an at-risk beneficiary for prescription drug addiction submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the ,,pdp sponsor select in response to a notice under subparagraph 7,b71 the ,,pdp sponsor shall-- 7aa7 review such preferences2 7bb7 select or change the selection of a prescriber or pharmacy for the beneficiary based on such preferences2 and 7cc7 inform the beneficiary of such selection or change of selection4 7,,ii7 ,exception ,in the case that the ,,pdp sponsor determines that a change to the selection of a prescriber or pharmacy under item 7bb7 by the ,,pdp sponsor is contributing or would contribute to prescription drug addiction or drug diversion by the beneficiary1 the ,,pdp sponsor may change the selection of a prescriber or pharmacy for the beneficiary without regard to the preferences of the beneficiary described in subclause 7,i74 7iv7 ,confirmation ,before selecting a prescriber or pharmacy under this subparagraph1 a ,,pdp sponsor must request and receive confirmation from the prescriber or pharmacy acknowledging and accepting that the beneficiary involved is in the drug management program for at-risk beneficiaries4 7,e7 ,terminations and appeals ,the identification of an individual as an at-risk beneficiary for prescription drug addiction under this paragraph1 a coverage determination made under a drug management program for at-risk beneficiaries1 and the selection of a prescriber or pharmacy under subparagraph 7,d7 with respect to such individual shall be subject to reconsideration and appeal under subsection 7h7 and the option of an automatic escalation to external review to the extent provided by the ,secretary4 7,f7 ,termination of identification 7i7 ,in general ,the ,secretary shall develop standards for the termination of identification of an individual as an at-risk beneficiary for prescription drug addiction under this paragraph4 ,under such standards such identification shall terminate as of the earlier of-- 7,i7 the date the individual demonstrates that the individual is no longer likely1 in the absence of the restrictions under this paragraph1 to be an at-risk beneficiary for prescription drug addiction described in subparagraph 7,c77i72 or 7,,ii7 the end of such maximum period of identification as the ,secretary may specify4 7ii7 ,rule of construction ,nothing in clause 7i7 shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription drug addiction under subparagraph 7,c77i7 after such termination on the basis of additional information on drug use occurring after the date of notice of such termination4 7,g7 ,addictive drug ,for purposes of this subsection1 the term addictive drug means a drug that is determined by the ,secretary to be addictive or frequently diverted and that is-- 7i7 a ,controlled ,drug ,substance in ,schedule ,,cii-,,civ2 7ii7 within the same class or category of drugs as a ,controlled ,drug ,substance in ,schedule ,,cii-,,civ2 or 7iii7 within another class or category of drugs that the ,secretary determines1 in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services1 is at high risk for diversion or addiction4 7,h7 ,data disclosure ,in the case of an at-risk beneficiary for prescription drug addiction whose access to coverage for addictive drugs under a prescription drug plan has been limited by a ,,pdp sponsor under this paragraph1 such ,,pdp sponsor shall disclose data1 including any necessary individually identifiable health information1 in a form and manner specified by the ,secretary1 about the decision to impose such limitations and the limitations imposed by the sponsor under this part4 7,i7 ,education ,the ,secretary shall provide education to enrollees in prescription drug plans of ,,pdp sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph1 including education-- 7i7 provided by ,medicare administrative contractors through the improper payment outreach and education program described in section #ahgd;,a7h72 and 7ii7 through current education efforts 7such as ,state health insurance assistance programs described in subsection 7a77#a77;,a7 of section #aai of the ,medicare ,improvements for ,patients and ,providers ,act of #bjjh 7#db ,u4,s4,c4 #acie;b-#c note77 and materials directed toward such enrollees4 4 7#b7 ,information for consumers ,section #ahfj;,d-#d7;a77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#a77;,b77 is amended by adding at the end the following3 7v7 ,the drug management program for at-risk beneficiaries under subsection 7c77#d74 4 7b7 ,utilization management programs ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c771 as amended by subsection 7a71 is amended-- 7#a7 in paragraph 7#a71 by inserting after subparagraph 7,d7 the following new subparagraph3 7,e7 ,a utilization management tool to prevent drug addiction 7as described in paragraph 7#e77;,a774 2 and 7#b7 by adding at the end the following new paragraph3 7#e7 ,utilization management tool to prevent drug addiction 7,a7 ,in general ,a tool described in this paragraph is any of the following3 7i7 ,a utilization tool designed to prevent addiction to addictive drugs by individuals and to prevent the diversion of such drugs at pharmacies4 7ii7 ,retrospective utilization review to identify-- 7,i7 individuals that receive addictive drugs at a frequency or in amounts that are not clinically appropriate2 and 7,,ii7 providers of services or suppliers that may facilitate the addiction to or diversion of addictive drugs by beneficiaries4 7iii7 ,consultation with the ,contractor described in subparagraph 7,b7 to verify if an individual enrolling in a prescription drug plan offered by a ,,pdp sponsor has been previously identified by another ,,pdp sponsor as an individual described in clause 7ii77,i74 7,b7 ,reporting ,a ,,pdp sponsor offering a prescription drug plan in a ,state shall submit to the ,secretary and the ,medicare drug integrity contractor with which the ,secretary has entered into a contract under section #ahic with respect to such ,state a report1 on a monthly basis1 containing information on-- 7i7 any provider of services or supplier described in subparagraph 7,a77ii77,,ii7 that is identified by such plan sponsor during the #cj-;day period before such report is submitted2 and 7ii7 the name and prescription records of individuals described in paragraph 7#d77;,c74 4 7c7 ,expanding ,activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs7 ,section #ahic of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;ddd7 is amended by adding at the end the following new subsection3 7j7 ,expanding ,activities of ,medicare ,drug ,integrity ,contractors 7,m,e,d,i,cs7 7#a7 ,access to information ,under contracts entered into under this section with ,medicare drug integrity contractors1 the ,secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies1 prescription drug plans1 and physicians with respect to an individual in order for such contractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug addiction1 as defined in section #ahfj;,d-#d7;c77#d77;,c74 7#b7 ,requirement for acknowledgment of referrals ,if a ,,pdp sponsor refers information to a contractor described in paragraph 7#a7 in order for such contractor to assist in the determination described in such paragraph1 the contractor shall-- 7,a7 acknowledge to the ,,pdp sponsor receipt of the referral2 and 7,b7 in the case that any ,,pdp sponsor contacts the contractor requesting to know the determination by the contractor of whether or not an individual has been determined to be an individual described such paragraph1 shall inform such ,,pdp sponsor of such determination on a date that is not later than #ae days after the date on which the ,,pdp sponsor contacts the contractor4 7#c7 ,making data available to other entities 7,a7 ,in general ,for purposes of carrying out this subsection1 subject to subparagraph 7,b71 the ,secretary shall authorize ,m,e,d,i,cs to respond to requests for information from ,,pdp sponsors1 ,state prescription drug monitoring programs1 and other entities delegated by ,,pdp sponsors using available programs and systems in the effort to prevent fraud1 waste1 and abuse4 7,b7 ,,hipaa compliant information only ,information may only be disclosed by a ,,medic under subparagraph 7,a7 if the disclosure of such information is permitted under the ,federal regulations 7concerning the privacy of individually identifiable health information7 promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 4 7d7 ,treatment of certain complaints for purposes of quality or performance assessment ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb7 is amended by adding at the end the following new subsection3 7d7 ,treatment of certain complaints for purposes of quality or performance assessment ,in conducting a quality or performance assessment of a ,,pdp sponsor1 the ,secretary shall develop or utilize existing screening methods for reviewing and considering complaints that are received from enrollees in a prescription drug plan offered by such ,,pdp sponsor and that are complaints regarding the lack of access by the individual to prescription drugs due to a drug management program for at-risk beneficiaries4 4 7e7 ,,gao studies and reports 7#a7 ,studies ,the ,comptroller ,general of the ,united ,states shall conduct a study on each of the following3 7,a7 ,the implementation of the amendments made by this section4 7,b7 ,the effectiveness of the at-risk beneficiaries for prescription drug addiction drug management programs authorized by section #ahfj;,d-#d7;c77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77#d771 as added by subsection 7a77#a71 including an analysis of-- 7i7 the impediments1 if any1 that impair the ability of individuals described in subparagraph 7,c7 of such section #ahfj;,d-#d7;c77#d7 to access clinically appropriate levels of prescription drugs2 and 7ii7 the types of-- 7,i7 individuals who1 in the implementation of such section1 are determined to be individuals described in such subparagraph2 and 7,,ii7 prescribers and pharmacies that are selected under subparagraph 7,d7 of such section4 7#b7 ,reports ,not later than ,january #a1 #bjag1 the ,comptroller ,general of the ,united ,states shall begin work1 with respect to each study described in paragraph 7#a71 on a report that describes the result of such study4 ,upon the completion of each such report1 such ,comptroller ,general shall submit the report to each of the committees described in paragraph 7#c74 7#c7 ,committees described ,the committees described in this paragraph are the following3 7,a7 ,the ,committee on ,ways and ,means of the ,house of ,representatives4 7,b7 ,the ,committee on ,energy and ,commerce of the ,house of ,representatives4 7,c7 ,the ,committee on ,finance of the ,senate4 7,d7 ,the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7,e7 ,the ,special ,committee on ,aging of the ,senate4 7f7 ,effective date 7#a7 ,in general ,the amendments made by this section shall apply to prescription drug plans for plan years beginning on or after ,january #a1 #bjah4 7#b7 ,stakeholder meetings prior to effective date 7,a7 ,in general ,not later than ,january #a1 #bjag1 the ,secretary shall convene stakeholders1 including individuals entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act or enrolled under part ,b of such title of such ,act1 advocacy groups representing such individuals1 clinicians1 plan sponsors1 and entities delegated by plan sponsors1 for input regarding the topics described in subparagraph 7,b74 7,b7 ,topics described ,the topics described in this subparagraph are the topics of-- 7i7 ensuring affordability and accessibility to prescription drugs for enrollees in prescription drug plans of ,,pdp sponsors who are at-risk beneficiaries for prescription drug addiction 7as defined in paragraph 7#d77;,c7 of section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c771 as added by subsection 7a77#a772 7ii7 the use of an expedited appeals process under which such an enrollee may appeal an identification of such enrollee as an at-risk beneficiary for prescription drug addiction under such paragraph 7similar to the processes established under the ,medicare ,advantage program under part ,c of title ,,xviii of the ,social ,security ,act that allow an automatic escalation to external review of claims submitted under such part72 7iii7 the types of enrollees that should be treated as exempted individuals1 as described in clause 7ii7 of such paragraph2 7iv7 the manner in which terms and definitions in paragraph 7#d7 of such section #ahfj;,d-#d7;c7 should be applied1 such as the use of clinical appropriateness in determining whether an enrollee is an at-risk beneficiary for prescription drug addiction as defined in subparagraph 7,c7 of such paragraph 7#d72 7v7 the information to be included in the notices described in subparagraph 7,b7 of such section and the standardization of such notices2 and 7vi7 with respect to a ,,pdp sponsor that establishes a drug management program for at-risk beneficiaries under such paragraph 7#d71 the responsibilities of such ,,pdp sponsor with respect to the implementation of such program4 7,c7 ,rulemaking ,the ,secretary shall promulgate regulations based on the input gathered pursuant to subparagraph 7,a74