,,ii #aagth ,,congress #b;d ,session ,s4 #cfbi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #aj1 #bjbb,mr4 ,markey 7for himself and ,mr4 ,paul7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to authorize a study on certain exemptions for treatment of opioid use disorder through opioid treatment programs during the ,,covid-#ai public health emergency1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,opioid ,treatment ,access ,act of #bjbb4 #b4 ,study on exemptions for treatment of opioid use disorder through opioid treatment programs during the ,,covid-#ai public health emergency 7a7 ,study ,the ,assistant ,secretary for ,mental ,health and ,substance ,use shall conduct a study1 in consultation with patients and other stakeholders1 on activities carried out pursuant to exemptions granted-- 7#a7 to a ,state 7including the ,district of ,columbia or any territory of the ,united ,states7 or an opioid treatment program2 7#b7 pursuant to section #h4aa7;h7 of title #db1 ,code of ,federal ,regulations2 and 7#c7 during the period-- 7,a7 beginning on the declaration of the public health emergency for the ,,covid-#ai pandemic under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bgd72 and 7,b7 ending on the earlier of-- 7i7 the termination of such public health emergency1 including extensions thereof pursuant to such section #cai2 and 7ii7 the end of calendar year #bjbb4 7b7 ,issues ,to be studied ,the study under subsection 7a7 shall1 with respect to exemptions described in such subsection1 include consideration of each of the following3 7#a7 ,the number of participating patients in each ,state4 7#b7 ,the percentage of participating patients in each ,state relative to the total number of patients in the respective ,state receiving treatment through an opioid treatment program4 7#c7 ,the number of participating patients in each ,state who cease treatment4 7#d7 ,the number of participating patients in each ,state who overdose on an opioid and cease treatment4 7#e7 ,the number of participating patients in each ,state who overdose on an opioid and continue treatment4 7#f7 ,the number of participating opioid treatment programs in each ,state4 7#g7 ,the percentage of participating opioid treatment programs in each ,state relative to the total number of opioid treatment programs in the respective ,state4 7#h7 ,the demographic1 socioeconomic1 and geographic characteristics of the participating patients and opioid treatment programs4 7#i7 ,any additional costs or savings from exemptions in each ,state4 7#aj7 ,an analysis of differences in the use of exemptions among ,states4 7#aa7 ,rates of medication adherence and diversion4 7c7 ,privacy ,the section does not authorize the disclosure by the ,department of ,health and ,human ,services of individually identifiable information about patients4 7d7 ,feedback ,in conducting the study under subsection 7a71 the ,assistant ,secretary for ,mental ,health and ,substance ,use shall gather feedback from the ,states and opioid treatment programs on their experiences in implementing exemptions described in subsection 7a74 7e7 ,report ,not later than #ahj days after the end of the period described in subsection 7a77#c77;,b71 and subject to subsection 7c71 the ,assistant ,secretary for ,mental ,health and ,substance ,use shall publish a report on the results of the study under this section4 #c4 ,changes to ,federal opioid treatment standards 7a7 ,mobile medication units ,section #cjb7;e7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7;e77 is amended by adding at the end the following3 7#c7 ,notwithstanding paragraph 7#a71 a registrant that is dispensing pursuant to section #cjc7;g7 narcotic drugs to individuals for maintenance treatment or detoxification treatment shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant's practice to dispense such narcotics at locations other than the registrant's principal place of business or professional practice described in paragraph 7#a71 so long as the registrant meets such standards for operation of a mobile medication unit as the ,attorney ,general may establish4 4 7b7 ,clarification in consideration of patients' responsibility in handling opioid drugs for unsupervised use ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate a final regulation1 or issue guidance1 clarifying section #h4ab7;i77#b77;i7 of title #db1 ,code of ,federal ,regulations 7and making such other changes as may be necessary7 so that a medical director may determine that a patient is sufficiently responsible in handling opioid drugs for unsupervised use1 as described in such section #h4ab7;i77#b7 of such title #db1 even if there is evidence of recent use of drugs 7opioid or nonnarcotic1 including alcohol74 7c7 ,periods for take-,home supply requirements 7#a7 ,first regulation ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate a final regulation amending paragraphs 7i77#c77;i7 through 7i77#c77vi7 of section #h4ab of title #db1 ,code of ,federal ,regulations 7and making such other changes as may be necessary7 so that-- 7,a7 the references to #ij days in paragraphs 7i77#c77;i7 through 7i77#c77;iii7 of such section #h4ab are each reduced to not more than #de days2 7,b7 the reference to the remaining months of the first year in paragraph 7i77#c77;iv7 of such section #h4ab is reduced to the remaining days of not more than the first six months of treatment2 7,c7 the reference to #a year in paragraph 7i77#c77v7 of such section #h4ab is reduced to not more than #f months2 and 7,d7 the reference to #b years in paragraph 7i77#c77vi7 of such section #h4ab is reduced to not more than #a year4 7#b7 ,study ,not later than #ah months after the date of enactment of this ,act1 the ,assistant ,secretary for ,mental ,health and ,substance ,use shall-- 7,a7 complete a study1 in consultation with patients and other stakeholders1 on the impacts on patient rehabilitation of the changes made by the regulation under paragraph 7#a7 to the periods specified in section #h4ab7;i77#c7 of title #db1 ,code of ,federal ,regulations2 7,b7 submit a report to the ,congress on the results of such study2 and 7,c7 include in such report recommendations for policy changes4 7#c7 ,second regulation 7,a7 ,in general ,not later than two years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate a final regulation amending paragraphs 7i77#c77;i7 through 7i77#c77vi7 of section #h4ab of title #db1 ,code of ,federal ,regulations1 as appropriate based on the findings of the study under paragraph 7#b74 7,b7 ,limitation ,the regulation under subparagraph 7,a7 shall not amend section #h4ab of title #db1 ,code of ,federal ,regulations1 so as to-- 7i7 allow the dispensing of more than two consecutive doses of methadone for take-home use per week before the patient's #cjth day of treatment2 or 7ii7 prohibit a patient determined to be responsible in handling opioids from being given a maximum of a one-month supply of methadone for take-home use after two years of continuous treatment4 #d4 ,expansion of take-home prescribing of methadone through pharmacies 7a7 ,registration2 other care by telehealth ,section #cjc7;g7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77 is amended-- 7#a7 in paragraph 7#a71 by striking in paragraph 7#b7 and inserting in paragraphs 7#b7 and 7#c72 and 7#b7 by adding at the end the following3 7#c7 7,a7 ,at the request of a ,state1 the ,attorney ,general1 in consultation with the ,secretary1 may1 pursuant to paragraph 7#a71 register persons described in subparagraph 7,b7 to prescribe methadone to be dispensed through a pharmacy for individuals for unsupervised use4 7,b7 ,persons described in this subparagraph are persons who-- 7i7 are licensed1 registered1 or otherwise permitted1 by the ,united ,states or the jurisdiction in which they practice1 to prescribe controlled substances in the course of professional practice2 and 7ii7 are-- 7,i7 employees or contractors of an opioid treatment program2 or 7,,ii7 addiction medicine physicians or addiction psychiatrists who hold a subspecialty board certification in addiction medicine from the ,american ,board of ,preventive ,medicine1 a board certification in addiction medicine from the ,american ,board of ,addiction ,medicine1 a subspecialty board certification in addiction psychiatry from the ,american ,board of ,psychiatry and ,neurology1 or a subspecialty board certification in addiction medicine from the ,american ,osteopathic ,association4 7,c7 ,the prescribing of methadone pursuant to subparagraph 7,a7 shall be-- 7i7 exclusively by electronic prescribing2 7ii7 for a supply of not more than #a month pursuant to each prescription2 and 7iii7 subject to the restrictions listed in section #h4ab7;i77#c7 of title #db1 ,code of ,federal ,regulations1 including any amendments or exemptions to such section pursuant to section #c7;c7 of the ,opioid ,treatment ,access ,act of #bjbb1 or successor regulations or guidance4 7,d7 ,the dispensing of methadone to an individual pursuant to subparagraph 7,a7 shall be in addition to the other care which the individual continues to have access to through an opioid treatment program4 7,e7 ,persons registered in a ,state pursuant to subparagraph 7,a7 shall-- 7i7 ensure and document1 with respect to each patient treated pursuant to subparagraph 7,a71 informed consent to treatment2 and 7ii7 include in such informed consent1 specific informed consent regarding differences in confidentiality protections applicable when dispensing through an opioid treatment program versus dispensing through a pharmacy pursuant to subparagraph 7,a74 7,f7 ,at the request of a ,state1 the ,attorney ,general1 in consultation with the ,secretary1 shall-- 7i7 cease registering persons in the ,state pursuant to subparagraph 7,a72 and 7ii7 withdraw any such registration in effect for a person in the ,state4 7,g7 ,maintenance treatment or detoxification treatment provided pursuant to subparagraph 7,a71 as well as other care provided in conjunction with such treatment1 such as counseling and other ancillary services1 may be provided by means of telehealth as determined jointly by the ,state and the ,secretary to be feasible and appropriate4 4 7b7 ,annual reporting ,not later than #f months after the date of enactment of this ,act1 and annually thereafter1 the ,assistant ,secretary for ,mental ,health and ,substance ,use and the ,administrator of the ,drug ,enforcement ,agency1 acting jointly1 shall submit a report to the ,congress including-- 7#a7 the number of persons registered pursuant to section #cjc7;g77#c7 of the ,controlled ,substances ,act1 as added by subsection 7a72 7#b7 the number of patients being prescribed methadone pursuant to such section #cjc7;g77#c72 and 7#c7 a list of the ,states in which persons are registered pursuant to such section #cjc7;g77#c74 #e4 ,sense of ,congress on need to reduce barriers to patient care through opioid treatment programs ,it is the sense of the ,congress that-- 7#a7 patients receiving services through opioid treatment programs face barriers to their care2 and 7#b7 each ,state should align its regulation of opioid treatment programs in a manner that is consistent with the intent of this ,act4