,,ii #aacth ,,congress #ast ,session ,s4 #cdh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #ad1 #bjac ,mr4 ,rockefeller 7for himself1 ,mr4 ,manchin1 and ,mrs4 ,gillibrand7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to provide for increased ,federal oversight of prescription opioid treatment and assistance to ,states in reducing opioid abuse1 diversion1 and deaths4 #a4 ,short title ,this ,act may be cited as the ,prescription ,drug ,abuse ,prevention and ,treatment ,act of #bjac4 #b4 ,findings ,congress makes the following findings3 7#a7 ,nonmedical use of prescription pain relievers is a matter of increasing public health concern4 ,according to the ,substance ,abuse and ,mental ,health ,services ,administration1 the proportion of all substance abuse treatment admissions aged #ab or older that reported any pain reliever abuse increased more than #djj percent between #aiih and #bjjh1 from #b4b to #i4h percent4 7#b7 ,in #bjjh1 among the population of the ,united ,states aged #ab or older1 nonmedical use of prescription pain relievers was the second most prevalent type of illicit drug use1 after marijuana use4 7#c7 ,when used properly under medical supervision1 prescription opiates enable individuals with chronic pain to lead productive lives4 ,however1 when taken without a physician's oversight and direction1 opiates can cause serious adverse health effects1 resulting in dependence1 abuse1 and death4 7#d7 ,as with any controlled substance1 there is a risk of abuse of methadone and other opiates4 7#e7 ,methadone is an extensively tested1 federally approved1 and widely accepted method of treating addiction to prescription pain relievers or opiates4 7#f7 ,for more than #cj years1 this synthetic prescription drug has been used for pain management and treatment for addiction to heroin1 morphine1 and other opioid drugs4 7#g7 ,the efficacy and lower cost of methadone has resulted in its being prescribed for pain management4 7#h7 ,prescriptions for methadone have increased by nearly #gjj percent from #aiih through #bjjf4 7#i7 ,according to the ,centers for ,disease ,control and ,prevention1 the number of poisoning deaths involving methadone increased nearly #g-;fold from almost #gij in #aiii to almost #e1dbj in #bjjf1 which is the most rapid increase among opioid analgesics and other narcotics involved in poisoning deaths4 7#aj7 ,the age-specific rates of methadone death are higher for persons age #ce to #dd and #de to #ed than for other age groups4 ,however1 the rate of methadone deaths in younger individuals 7age #ae to #bd7 increased #aa-;fold from #aiii through #bjje4 7#aa7 ,deaths from methadone and other opiates may actually be underreported4 ,there is no comprehensive database of drug-related deaths in the ,united ,states4 7#ab7 ,the lack of standardized reporting by ,medical ,examiners precludes a uniform definition of cause of death on death certificates4 7#ac7 ,the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 requires that every person who dispenses or who proposes to dispense controlled narcotics1 including methadone1 whether for pain management or opioid treatment obtain a registration from ,drug ,enforcement ,administration4 ,unfortunately there is no requirement as a condition of receiving the registration that these practitioners receive any education on the use of these controlled narcotics1 including methadone4 7#ad7 ,current ,federal oversight of methadone and other opioids is inadequate to address the growing number of opioid-related overdoses and deaths4 7#ae7 ,federal legislation is needed to avert opioid abuse1 misuse1 and death1 without reducing patient access to needed care4 #c4 ,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 abuse1 including methadone abuse4 ,such education shall include information on the dangers of opioid abuse1 how to prevent opioid abuse 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 abuse of 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 abuse of 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 #bjad through #bjah4 4 #d4 ,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 #af-;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 #af 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 #bjad1 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 #e4 ,moratorium on methadone hydrochloride tablets 7a7 ,in general ,notwithstanding any other provision of law1 during the period beginning on the date of enactment of this ,act and ending on the date described in subsection 7b71 no individual or entity may prescribe or otherwise dispense a #dj-mg diskette of methadone unless such prescription or dispensation is consistent with the methadone #dj-mg diskette policy of the ,drug ,enforcement ,administration as in effect on the date of enactment of this ,act1 except that such prohibition shall extend to hospitals unless such hospitals provide for direct patient supervision with respect to such methadone4 7b7 ,ending date of moratorium ,the moratorium under subsection 7a7 shall cease to have force and effect-- 7#a7 on the date that the ,controlled ,substances ,clinical ,standards ,commission publishes in the ,federal ,register dosing guidelines for all forms of methadone1 in accordance with section #ejf;,d7b77#a77;,a7 of the ,public ,health ,service ,act 7as added by section #g72 and 7#b7 if1 as part of such dosing guidelines1 such ,commission finds that #dj-mg diskettes of methadone are safe and clinically appropriate4 #f4 ,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 #g4 ,establishment of the ,controlled ,substances ,clinical ,standards ,commission ,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 ,establishment of the ,controlled ,substances ,clinical ,standards ,commission 7a7 ,in general ,the ,secretary shall establish a ,controlled ,substances ,clinical ,standards ,commission 7referred to in this section as the ,commission71 to be composed of representatives from the ,administration1 the ,centers for ,disease ,control and ,prevention1 the ,food and ,drug ,administration1 the ,pain ,management ,consortia of the ,national ,institutes of ,health1 and other agencies that the ,secretary may deem necessary1 to develop-- 7#a7 appropriate and safe dosing guidelines for all forms of methadone1 including recommendations for maximum daily doses of all forms as provided for in subsection 7b77#a72 7#b7 benchmark guidelines for the reduction of methadone abuse1 as provided for in subsection 7b77#b72 7#c7 appropriate conversion factors for use by health care providers in transitioning patients from one opioid to another2 7#d7 specific guidelines for initiating pain management with methadone that prescribing practitioners shall comply with in order to meet certification requirements set forth in part ,c of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hba et seq472 and 7#e7 patient and practitioner education guidelines for both methadone maintenance therapy and pain management that apply to safe and effective use and include detoxification4 7b7 ,guidelines 7#a7 ,publication of dosing guidelines 7,a7 ,in general ,not later than #b years after the date of enactment of this section1 the ,commission established under subsection 7a7 shall publish in the ,federal ,register-- 7i7 safe and clinically appropriate dosing guidelines for all forms of methadone used for both pain management and opioid treatment programs1 including recommendations for maximum daily doses of all forms1 including recommendations for the induction process for patients who are newly prescribed methadone2 7ii7 requirements for individual patient care plans1 including initial and follow-up patient physical examination guidelines1 and recommendations for screening patients for chronic or acute medical conditions that may cause an immediate and adverse reaction to methadone2 7iii7 appropriate conversion factors for use by health care providers in transitioning patients from one opioid to another2 7iv7 specific guidelines for initiating pain management with methadone1 that prescribing physicians or other clinicians shall comply with in order to meet ,drug ,enforcement ,administration certification and re-certification requirements2 and 7v7 consensus guidelines for pain management with prescription opioid drugs4 7,b7 ,updating of guidelines ,not later than #c years after the publication of guidelines under subparagraph 7,a71 and at least every #c years thereafter1 the ,commission shall update such guidelines4 7#b7 ,publication of benchmark guidelines 7,a7 ,in general ,not later than #c years after the date of enactment of this section1 the ,commission established under subsection 7a7 shall publish in the ,federal ,register-- 7i7 the initial benchmark guidelines for the reduction of methadone abuse to be used-- 7,i7 by opioid treatment programs in providing methadone therapy2 and 7,,ii7 by entities in the initial accreditation or certification1 and the re-accreditation and re-certification1 of such opioid treatment programs2 7ii7 a model policy for dispensing methadone to be used by pharmacists that dispense methadone1 which should include education and training guidelines for such pharmacists2 7iii7 the continuing education guidelines that all prescribers shall comply with in order to meet ,drug ,enforcement ,administration certification and re-certification requirements1 as set forth in section #cjc7;g77#c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#c771 which should include a minimum of #af training hours at least every #c years that include the integration of both addiction and pain management curricula2 and 7iv7 patient education guidelines for both opioid treatment programs and pain management1 including recommendations for patient counseling prior to and during opioid addiction treatment or treatment for pain4 7,b7 ,updating of guidelines ,not later than #a year after the publication of guidelines under subparagraph 7,a71 and at least annually thereafter1 the ,commission shall update the guidelines published under clauses 7iii7 and 7iv7 of such subparagraph4 7#c7 ,consultation ,in developing and publishing the guidelines under this section1 the ,commission shall consult with relevant professional organizations with expertise in the area of addiction1 relevant professional organizations with expertise in the area of pain management1 physician groups1 pharmacy groups 7including the ,national ,association of ,boards of ,pharmacy71 patient representatives1 and any other organization that the ,secretary determines is appropriate for purposes of this section4 7c7 ,website ,not later than #ahj days after the date of enactment of this section1 the ,commission shall establish and operate a ,commission website4 7d7 ,methadone toolkit ,not later than #a year after the date of enactment of this section1 the ,commission shall establish1 and distribute to practitioners that are registered to prescribe or otherwise dispense methadone1 a methadone toolkit4 ,the ,commission shall make the components of the toolkit that are available in electronic form available on the ,commission website4 7e7 ,practitioner education program ,the ,commission shall develop a practitioner education program that shall be used for the practitioner education described in section #cjc7;g77#c7 of the ,controlled ,substances ,act1 and shall make such program available to providers of such practitioner education4 7f7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years #bjad through #bjah4 4 #h4 ,prescription monitoring program ,section #cii,o of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#c7 is amended-- 7#a7 in subsection 7d77#a71 by inserting 7including prescribers of methadone7 after dispensers2 7#b7 in subsection 7e71 by adding at the end the following3 7#e7 ,subject to the requirements of section #edc1 the ,state shall1 at the request of a ,federal1 ,state1 or local officer whose duties include enforcing laws relating to drugs1 provide to such officer information from the database relating to an individual who is the subject of an active drug-related investigation conducted by the officer's employing government entity4 2 and 7#c7 by striking subsection 7n7 and inserting the following3 7n7 ,appropriations ,there is authorized to be appropriated to carry out this section #be1jjj1jjj for each of fiscal years #bjad through #bjah4 4 #i4 ,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 #g1 is further amended by adding at the end the following3 #ejf;,e4 ,mortality reporting 7a7 ,model ,opioid ,treatment ,program ,mortality ,report 7#a7 ,in general ,not later than ,july #a1 #bjad1 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 #bjad1 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 non-personal 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 #bjad through #bjah 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 #aj4 ,additional 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 #i1 is further amended by adding at the end the following3 #ejf;,f4 ,additional reporting 7a7 ,report on methadone usage 7#a7 ,in general ,not later than ,january #a of the first fiscal year beginning #b years after the date of enactment of this section1 and each ,january #a thereafter1 the ,administrator and the ,commissioner of ,food and ,drugs shall submit to the ,secretary a report containing detailed statistics on methadone usage for opioid treatment and pain management4 ,such statistics shall include-- 7,a7 information on the distribution of prescribed doses of methadone at federally qualified health centers1 opioid treatment clinics1 other health-related clinics1 physician offices1 pharmacies1 and hospitals2 and 7,b7 information relating to adverse health events resulting from such methadone usage4 7#b7 ,availability of information ,the ,secretary shall make the reports submitted under paragraph 7#a7 available to the general public1 including through the use of the ,internet website of the ,department of ,health and ,human ,services4 7b7 ,annual report on effectiveness ,not later than ,september #cj1 #bjad1 and annually thereafter until ,september #cj1 #bjaf1 the ,secretary shall submit to the appropriate committees of ,congress1 a report concerning the effectiveness of the methadone maintenance therapy program4 ,such report shall evaluate the success of efforts to reduce opioid addiction and methadone-related deaths1 including the impact of health care provider and patient education4 7c7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years #bjad through #bjah4 4 #aa4 ,development of prescription drug abuse 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 abuse 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 abuse prevention and treatment quality measures for each relevant health care provider setting1 as identified by the ,director4 7b7 ,dissemination ,not later than ,april #a1 #bjaf1 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