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Wednesday, January 17, 2001 Part II Department of Health and Human Services Substance Abuse and Mental Health Services Administration 21 CFR Part 291 42 CFR Part 8 Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Final Rule VerDate 11<MAY>2000 15:29 Jan 16, 2001 Jkt 194001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\17JAR2.SGM pfrm08 PsN: 17JAR2

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Page 1: 42 CFR Part 8 Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Final Rule

Wednesday,

January 17, 2001

Part II

Department ofHealth and HumanServicesSubstance Abuse and Mental HealthServices Administration

21 CFR Part 291

42 CFR Part 8Opioid Drugs in Maintenance andDetoxification Treatment of OpiateAddiction; Final Rule

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4076 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Substance Abuse and Mental HealthService Administration

21 CFR Part 291

42 CFR Part 8

[Docket No. 98N–0617]

RIN 0910–AA52

Opioid Drugs in Maintenance andDetoxification Treatment of OpiateAddiction;

AGENCY: Substance Abuse and MentalHealth Services Administration, HHS.ACTION: Final rule.

SUMMARY: The Department of Health andHuman Services and the SubstanceAbuse and Mental Health ServicesAdministration (SAMHSA) are issuingfinal regulations for the use of narcoticdrugs in maintenance and detoxificationtreatment of opioid addiction. This finalrule repeals the existing narcotictreatment regulations enforced by theFood and Drug Administration (FDA),and creates a new regulatory systembased on an accreditation model. Inaddition, this final rule shiftsadministrative responsibility andoversight from FDA to SAMHSA. Thisrulemaking initiative follows a study bythe Institute of Medicine (IOM) andreflects recommendations by the IOMand several other entities to improveopioid addiction treatment by allowingfor increased medical judgment intreatment.DATES: This final rule will becomeeffective on March 19, 2001.FOR FURTHER INFORMATION CONTACT:Nicholas Reuter, Center for SubstanceAbuse Treatment (CSAT), SAMHSA,Rockwall II, 5600 Fishers Lane, Rm 12–05, Rockville, MD 20857, 301–443–0457, email: [email protected] INFORMATION:

I. BackgroundIn the Federal Register of July 22,

1999, (64 FR 39810, July 22, 1999,hereinafter referred to as the July 22,1999, notice or July 22, 1999, proposal)SAMHSA, FDA, and the Secretary,Health and Human Services (HHS),jointly published a Notice of ProposedRulemaking (NPRM) to revise theconditions for the use of narcotic drugsin maintenance and detoxificationtreatment of opioid addiction. Theagencies also proposed the repeal of theexisting narcotic treatment regulationsenforced by the FDA, the creation of anew regulatory system based on an

accreditation model under new 42 CFRpart 8, and a shift in administrativeresponsibility and oversight from FDAto SAMHSA.

The July 22, 1999, notice traced thehistory of Federal regulatory oversightof Opioid Treatment Programs (‘‘OTPs,’’also known as narcotic treatmentprograms, or, methadone programs),focusing on Federal regulationsenforced by FDA since 1972. The July22, 1999, notice summarized theperiodic reviews, studies, and reportson the Federal oversight system,culminating with the 1995 Institute ofMedicine (IOM) Report entitled, FederalRegulation of Methadone Treatment(Ref. 1). As noted in the July 22, 1999,proposal, the IOM report recommendedthat the existing FDA process-orientedregulations should be reduced in scopeto allow more clinical judgment intreatment and greater reliance onguidelines. The IOM report alsorecommended designing a singleinspection format, having multipleelements, that would (1) provide forconsolidated, comprehensiveinspections conducted by one agency(under a delegation of Federal authority,if necessary), which serves all agencies(Federal, State, local) and (2) improvethe efficiency of the provision ofmethadone services by reducing thenumber of inspections andconsolidating their purposes.

To address these recommendations,SAMHSA proposed a ‘‘certification’’system, with certification based onaccreditation. Under the system, as setforth in the July 22, 1999, proposal, apractitioner who intends to dispenseopioid agonist medications in thetreatment of opiate addiction must firstobtain from SAMHSA, a certificationthat the practitioner is qualified underthe Secretary’s standards and willcomply with such standards. Eligibilityfor certification will depend upon thepractitioner obtaining accreditationfrom a private nonprofit entity, or froma State agency, that has been approvedby SAMHSA to accredit OTPs.Accreditation bodies would baseaccreditation decisions on a review ofan application for accreditation and onsurveys (on site inspections) conductedevery three years by addiction treatmentexperts. In addition, accreditationbodies will apply specific opioidtreatment accreditation elements thatreflect ‘‘state-of-the-art’’ opioidtreatment guidelines. Moreover,accreditation standards will require thatOTPs have quality assurance systemsthat consider patient outcomes.

As noted in the July 22, 1999,proposal, this new system wouldreplace the existing FDA regulatory

system. The existing system provides forFDA ‘‘approval’’ of programs, withdirect government inspection inaccordance with more detailed process-oriented regulations. These process-oriented regulations are less flexible andprescribe many aspects of treatment.The existing regulations do not requirethat programs have quality assurancesystems. Finally, under the existingsystem, programs are not subject toperiodic certification and there is no setschedule for inspections.

Proposed Subpart A addressedaccreditation and included steps thataccreditation bodies will follow toachieve approval to accredit OTPsunder the new system. It also set forththe accreditation bodies’responsibilities, including the use ofaccreditation elements duringaccreditation surveys. Proposed SubpartB established the sequence andrequirements for obtaining certification.This section addressed how and whenprograms must apply for initialcertification and renewal of theircertification. Finally, Subpart C ofproposed part 8 established theprocedures for review of the withdrawalof approval of the accreditation body orthe suspension and proposed revocationof an OTP certification.

In addition to proposing an entirelynew oversight system, the July 22, 1999,proposal included several other newprovisions. For example, the Federalopioid treatment standards weresignificantly reduced in scope to allowmore flexibility and greater medicaljudgment in treatment. Certainrestrictions on dosage forms wereeliminated so that OTPs may now usesolid dosage forms. Under the previousrules, OTPs were limited to the use ofliquid dosage forms. Several reportingrequirements and reporting forms wereeliminated, including the requirementsfor physician notifications (FDAReporting Form 2633) and therequirement that programs obtain FDAapproval prior to dosing a patient above100 milligrams. The proposal includeda more flexible schedule for medicationsdispensed to patients for unsuperviseduse, including provisions that permit upto a 31-day supply. Under the currentregulations, patients are limited to amaximum 6-day supply of medication.Many of these regulatory requirementshad been in place essentially unchangedfor almost 30 years.

SAMHSA distributed the July 22,1999, notice to each OTP listed in thecurrent FDA inventory, each StateMethadone Authority, and to otherinterested parties. Interested partieswere given 120 days, until November19, 1999, to comment on the July 22,

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1999, proposal. In addition, onNovember 1, 1999, SAMHSA, FDA, theOffice of National Drug Control Policy(ONDCP), the Drug EnforcementAdministration (DEA), and otherFederal agencies convened a PublicHearing on the proposal. The PublicHearing was announced in the FederalRegister published October 19, 1999,(64 FR 59624, October 19, 1999), andwas held in Rockville, MD. On January31 and May 10, 2000, the SAMHSA/CSAT National Advisory CouncilSubcommittee on Accreditation met toassist SAMHSA/CSAT in its review ofdata and information from SAMHSA/CSAT’s ongoing accreditation project.The SAMHSA/CSAT National AdvisoryCouncil convened to discuss the opioidaccreditation project on May 12, 2000.The May 12, 2000, Council meetingprovided an opportunity for commentsfrom the public (65 FR 25352, May 1,2000).

II. Comments and Agency Response

In response to the July 22, 1999,proposal, SAMHSA received almost 200submissions, each containing one ormore comments. The comments werefrom government, industry, industrytrade associations, academia, healthprofessionals, professionalorganizations, patient advocacyorganizations, and individual patients.

A. General Comments

1. Many comments agreed inprinciple that the shift to anaccreditation-based system willencourage OTPs to use individualized,clinically determined treatment plansthat are guided by current, best-practicemedical and clinical guidelines and toevaluate clinical outcomes. Othercomments noted that the accreditationproposal recognizes that opiateaddiction is a medical condition.Several comments affirmed that a majorsegment of the healthcare system in theUnited States is being reviewed throughaccreditation systems. As such, thesecomments stated that applyingaccreditation requirements to OTPsprovides the potential for mainstreammedicine to embrace opioid treatment.

While not opposing the proposal,some comments stated there should beno Federal regulations in this area.Other comments expressed concernsabout additional costs to OTPs and,ultimately patients, for accreditationand duplicative assessments, noting thatsome States will continue to enforceprocess-oriented regulations, supportedby considerable licensing fees. Basedupon these ‘‘uncertainties,’’ thesecomments suggest that SAMHSA wait

for the results of further study beforeimplementing new regulations.

The Secretary agrees that theSAMHSA-administered accreditation-based regulatory system will encouragethe use of best-practice clinicalguidelines and require qualityimprovement standards with outcomeassessments. As set forth below, theSecretary does not agree that commentson the uncertainty about accreditationcosts or State regulatory activitieswarrant additional study beforeimplementing these new rules.

2. Several comments addressed thecosts associated with accreditation andchallenged the estimates provided in theJuly 22, 1999, proposed rule. Onecomment included the results from asurvey of OTPs with accreditationexperience to indicate the indirect costsof accreditation will be considerable.According to the comment, these OTPshave had to spend considerable sums tohire consultants and additional staff,upgrade computers, develop infectioncontrol manuals, and make physicalplant improvements. In some casesthese costs were reported to approach$50,000. Some of these commentssuggested that SAMHSA await thecompletion of the ‘‘accreditation impactstudy’’ to obtain additional informationon costs, before proceeding. Othercomments stated that accreditation canlead to increased treatment capacity, butonly if additional funds are provided.One comment suggested that SAMHSAcreate a capital improvement fund,while another suggested that SAMHSAallow block grant funds to be used topay for accreditation.

The Secretary believes that theestimated costs as set forth in the July22, 1999, notice remain reasonablyaccurate. As discussed in greater detailbelow, information on accreditationdeveloped under the accreditationimpact study, together with otherongoing SAMHSA technical assistanceprograms, indicates that theaccreditation system will not producean excessive burden to programs towarrant delaying the implementation ofthis final rule.

There are many components toSAMHSA’s accreditation project thathave been proceeding concurrently withthis rulemaking. In April 1999,SAMSHA’s Center for Substance AbuseTreatment (CSAT) issued ‘‘Guidelinesfor the Accreditation of OpioidTreatment Programs.’’ These guidelinesare up-to-date best-practice guidelinesthat are based upon the Federal opioidtreatment standards set forth underproposed section 8.12 as well asSAMHSA/CSAT’s TreatmentImprovement Protocols (TIPs) that

address opiate addiction treatment. Twoaccreditation bodies, the Commissionfor the Accreditation of RehabilitationFacilities (CARF) and the JointCommission for the Accreditation ofHealthcare Organizations (JCAHO),under contract to SAMHSA/CSAT, usedthese guidelines to develop ‘‘state-of-the-art’’ accreditation elements. Thesetwo accreditation bodies have surveyeddozens of programs with these newaccreditation standards.

The July 22, 1999, proposal describedan ongoing accreditation impact study.Under the accreditation impact study,CARF and JCAHO trained over 170participating OTPs. In addition, morethan 50 OTPs have been accreditedunder this system with technicalassistance provided through a contractfunded by SAMHSA/CSAT. None of theaccredited programs have had to incurthe kind of ‘‘physical plant’’ and othercostly expenses predicted by some ofthe comments previously discussed.This direct and up-to-date informationindicates that the cost estimates in theJuly 22, 1999, notice are up-to-date andreasonable. On the other hand, thesurvey discussed above that wassubmitted with one comment reflectedaccreditation surveys performed over 10years ago. And, in some cases, theaccreditation experiences discussed inthese comments reflect accreditation ofpsychiatric hospitals, not OTPs.

The accreditation-based system whichis the subject of this rule includessafeguards to reduce the risk ofunnecessary and overly burdensomeaccreditation activities relating to OTPs.For example, SAMHSA will approveeach accreditation body after reviewingits accreditation elements, accreditationprocedures, and other pertinentinformation. SAMHSA will conveneperiodically an accreditationsubcommittee, as part of the SAMHSA/CSAT National Advisory Council. Thesubcommittee will review accreditationactivities and accreditation outcomesand make recommendations to the fullSAMHSA/CSAT Council, andultimately to SAMHSA on accreditationactivities and guidelines. Finally,SAMHSA/CSAT has been providingtechnical assistance to OTPs in theaccreditation impact study that hashelped programs in achievingaccreditation. SAMHSA/CSAT intendsto continue providing technicalassistance on accreditation during the3–5 year transition period and possiblylonger.

The Secretary does not agree that it isnecessary to establish a special fund tohelp programs pay for accreditation feesand indirect ‘‘physical plant’’improvements in order for OTPs to be

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able to achieve accreditation. As notedabove, the Secretary believes that theestimates in the July 22, 1999, proposalfor the cost of accreditation arereasonably accurate (approximately $4–5 million per year, $5400 per OTP peryear, $39 per patient per year).Nonetheless, the Secretary has takensteps to minimize the potential effects ofthis burden to OTPs, especially to OTPsthat are small businesses or that operatein under-served communities. First, theSecretary has determined that Statescould use funds provided by SAMHSAunder their Substance Abuse Preventionand Treatment (SAPT) Block Grants tooffset costs of accreditation for programsqualified to receive assistance under theState’s SAPT block grant. Second,SAMSHA has included in its budget, aplan to continue funding accreditation.Finally, SAMHSA will continue toprovide technical assistance which willaid those programs that need help inachieving accreditation.

3. One OTP that is participating in theaccreditation impact study, whilecommending the accreditationexperience and accreditation in general,commented that the proposed change ispremature. Some comments suggestedthat SAMHSA postpone implementationfor an indefinite period to allow for anunspecified number of CARF andJCAHO accreditation results. Anothercomment stated that the first series ofsurveys will determine the utility of thefirst generation of standards, noting thatthe process can be focused and modifiedin response to results from the impactstudy. A few comments questionedwhether all providers can make thetransition.

On the other hand, many commentsstated that the field has been subject toregulatory neglect long enough, and thatSAMHSA should minimize the delay infinalizing rules. One commentsubmitted the results of a survey thatsuggested that as many as 155 OTPscurrently need technical assistance inorder to provide treatment inaccordance with standards andregulations.

The Secretary does not believe thatthese final regulations should bedelayed until the completion of theaccreditation impact study. As stated inthe July 22, 1999, proposal, theDepartment of Health and HumanServices (HHS) has determined thataccreditation is a valid and reliablesystem for providing externalmonitoring of the quality of healthcare—including substance abuse andmethadone treatment. The SAMHSA/CSAT study is designed to provideadditional information on the processes,barriers, administrative outcomes, and

costs associated with an accreditation-based system. In addition, the study isexpected to provide importantinformation to allow SAMHSA to keepits guidelines, and its accreditationprogram, as responsive and up-to-dateas possible. Among other things, thestudy will allow HHS to continuouslymonitor the monetary costs ofaccreditation, to ensure that successfulOTPs are not precluded from operatingby the costs of accreditation, and thatpatients are not denied treatment basedon costs. The full study, whichcompares a representative sample ofOTPs 6 months following accreditationto their baseline status across severalvariables, will require a few years tocomplete. Regulations can be modifiedat any time. If SAMHSA believes thatthe results of the study merit changes inthe regulations, then such changes willbe the subject of a future rulemaking.

The Secretary has reviewedpreliminary results from theaccreditation study by two accreditationbodies, CARF and JCAHO, of almost 10percent (approximately 80 OTPs) of theentire inventory of approved outpatientOTPs. Well over 90 percent of the OTPssurveyed achieved accreditation underthe ‘‘methadone specific’’ accreditationstandards. Only a very few programsrequired a follow-up survey to achieveaccreditation. And, to date, only oneOTP failed to achieve accreditation.These accreditation outcome results arecomparable to the historical compliancerate under the previous FDA process-oriented regulatory system. In addition,these rates correspond to the assumedaccreditation resurvey rate stated in theJuly 22, 1999, proposal for estimatingthe indirect costs of accreditation.

These accreditation outcome resultshave been analyzed and presented toSAMHSA/CSAT’s National AdvisoryCouncil’s Accreditation Subcommittee(NACAS). As discussed in the July 22,1999, proposal, SAMHSA/CSATaugmented NACAS with consultantsrepresenting OTPs (both large and smallprograms), medical and other substanceabuse professionals, patients, and Stateofficials. The subcommittee has mettwice, on January 31 and May 10, 2000,and the public was provided anopportunity to participate in thisadvisory process. On May 12, 2000, theSAMHSA/CSAT National AdvisoryCouncil urged SAMHSA/CSAT to moveexpeditiously to finalize the July 22,1999, proposal.

The Secretary believes that theinterim results from the accreditationimpact study confirm that theaccreditation guidelines, along with theaccreditation process itself, are a validand reliable method for monitoring the

quality of care provided by OTPs. Theresults indicate that most OTPs canachieve accreditation and that treatmentcapacity has not declined as a result.While SAMHSA intends to continue thestudy to fulfill its objectives, theSecretary does not believe that it isappropriate or necessary to delayimplementation of these new rules untilthe full study is complete.

4. Many comments, especially fromcurrent and past OTP patients,questioned the impact of revisedFederal regulations in light of Stateregulations. These comments contendthat State regulations are much morerestrictive on medical and clinicalpractices than Federal regulations, andthat State regulatory authorities haveexpressed little or no interest inchanging their regulations or the wayState regulations are enforced.Comments from OTP sponsors statedthat accreditation costs would add toState licensing fees, which, in someStates, exceed several thousand dollarsannually.

The Secretary shares the concernsexpressed in these comments aboutState regulations and licensingrequirements. Indeed, the July 22, 1999,proposal discussed State licensure andregulatory issues. The proposal alsonoted that there was considerablevariation in the nature and extent ofoversight at the State level. Some Stateshave regulations and enforcementprograms that exceed Federalregulations. Others have reliedexclusively upon FDA and DEAregulatory oversight. An increasingnumber of States rely on accreditation,by nationally recognized accreditationbodies, for all or part of their healthcarelicensing functions.

The Secretary believes thatSAMHSA’s ongoing coordinationactivities with States will minimize theimpact of Federal-State regulatorydisparities upon OTPs. One objective ofthese activities is to increase Stateauthorities’ acceptance of the newaccreditation-based system. First,SAMHSA/CSAT’s OTP accreditationguidelines were developed by aconsensus process that includedrepresentation from State MethadoneAuthorities. In addition, some Stateofficials have accompanied CARF andJCAHO accreditation survey teams toobserve site visits. Finally, SAMHSA/CSAT has distributed information onaccreditation to each State. Thisinformation includes the SAMHSA/CSAT OTP accreditation guidelines, theCARF OTP accreditation standards andthe JCAHO OTP accreditation standards.SAMHSA/CSAT convened threenational meetings of State officials

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between 1997 and 2000 and intends tocontinue coordinating activities withState authorities and nationalorganizations such as the NationalAssociation of State Alcohol and DrugAbuse Directors (NASADAD).

This final rule includes provisionsthat would permit any State to apply forapproval as an accreditation body and,if approved, accredit OTPs under thenew Federal opioid treatment standards.Based on the above, the Secretaryexpects that many states will considerOTP accreditation and Federalcertification requirements as sufficientto fulfill all or a substantial part of theirlicensing requirements. Taken together,the Secretary believes that thesemeasures will minimize significantlythe existing disparity between Federaland State regulation of OTPs.

5. Office-Based Treatment. The July22, 1999, proposal discussed theconcept of ‘‘office-based opioidtreatment’’ and specifically solicitedcomments on how the Federal opioidtreatment standards might be modifiedto accommodate office-based treatmentand on whether a separate set of Federalopioid treatment standards should beincluded in this rule for office-basedtreatment.

The Secretary received many diversecomments on the office-based treatmentissue. Several comments from patientsand individual physicians believed thatoffice-based treatment provided anexcellent opportunity to expand opioidagonist treatment. These commentsreference opioid treatment deliverysystems in other countries and suggestthat the U.S. should adopt similarsystems. A few commentsrecommended that communitypharmacies be encouraged to dispensemethadone and LAAM as ‘‘medicationunits’’ as a way to make treatment moreconvenient for patients.

While many comments suggestedseparate standards for office-basedtreatment, others feared that differentstandards would result in a two-tieredsystem of treatment. Overall manycomments stated that existing andproposed rules do not facilitate thedevelopment of the office-based practicemodel. As such, accreditation andcertification would be prohibitivelyexpensive for individual physicians.

On the other hand, many commentsexpressed concerns with the concept of‘‘office-based’’ treatment andprescribing methadone and LAAM.Many of these comments reflectedconcern about the lack of trained andexperienced practitioners. Onecomment referenced literature reportsthat described experiences in Australiaand the United Kingdom with deaths

from iatrogenic methadone toxicityassociated with patients early intreatment. The experiences in these twocountries were associated with anaccelerated rate of patient admissionsand the involvement of new,inexperienced practitioners. Onecomment cited research on methadonemedical maintenance that indicated thatapproximately 15 percent of the patientstreated in physicians offices werereferred back to OTPs after ‘‘relapsing’’to illicit opiate use.

Generally, most comments on thisissue stated that there was not enoughinformation on office-based practice.These comments suggest that based onthe available information, office-basedtreatment warrants a gradual, step-wiseapproach, along with more use ofmedication units. This approach wouldserve to ‘‘diffuse opioid agonistmaintenance treatment into traditionalsettings.’’

After carefully considering the diversecomments, as well as other legal andregulatory factors, the Secretary is notincluding in this rule specific standardsthat would permit physicians toprescribe methadone and LAAM inoffice-based settings without anaffiliation with an OTP. Instead, untiladditional information is generated, theSecretary is announcing administrativemeasures to facilitate the treatment ofpatients under a ‘‘medical maintenance’’model.

Current regulations enforced by DEAdo not permit registrants to prescribenarcotic drugs, including opioid agonistmedications such as methadone andLAAM for the treatment of narcoticaddiction (see 21 CFR 1306.07(a)). Inaddition, the Secretary agrees that, atthe present time, there should be somelinkage between OTPs and physicianswho treat stable patients withmethadone and LAAM in their offices toaddress patients’ psychosocial needs inthe event of relapse. The Secretaryagrees with the comments about the lackof trained and experienced practitionersto diagnose, admit, and treat opiateaddicts who are not sufficientlystabilized, without the support of anOTP.

The Secretary has taken steps tofacilitate ‘‘medical maintenance,’’ thatwill result in more patients receivingtreatment with methadone and LAAMin an office-based setting. Medicalmaintenance refers to the treatment ofstabilized patients with increasedamounts of take-home medication forunsupervised use and fewer clinic visitsfor counseling or other services. First,the ‘‘take home’’ provisions in theserules have been revised from theprevious regulations under 21 CFR

§ 291.505 to permit stabilized patientsup to a one-month supply of treatmentmedication. In addition, SAMHSA/CSAT has developed treatmentguidelines and training curricula forpractitioners to increase the informationand education for practitioners in thisarea. Finally, SAMHSA/CSAT hasissued announcements to the fieldexplaining how patients and treatmentprograms can obtain authorizations formedical maintenance. Theseauthorizations were developed toaddress program-wide exemptionsunder 21 CFR 291.505; however,SAMHSA/CSAT envisions a similarapproach will be used under theprogram-wide exemption provisions of42 CFR 8.11(h).

Under the medical maintenancemodel, office-based physicians maintainformal arrangements with establishedOTPs. Typically, patients who havebeen determined by a physician to bestabilized in treatment may be referredto office-based physicians. It has beenestimated that over 12,000 currentpatients would be eligible for medicalmaintenance treatment. The Secretarybelieves that this is a reasonableapproach that will expand treatmentcapacity gradually while additionalinformation and experience isdeveloped to evaluate and refine office-based treatment models.

B. Comments on Subpart A—Definitionsand Accreditation

Proposed subpart A sets forthdefinitions as well as procedures,criteria, responsibilities andrequirements relating to accreditation.

1. A comment from a State authoritysuggested that the treatment plandefinition under § 8.2 should bemodified to require a reference to theservices determined necessary to meetthe goals identified in the plan. TheSecretary agrees with this suggestionand has revised the treatment plandefinition accordingly.

2. One comment suggested that theproposed definition of detoxificationtreatment specifies agonist and thereforeprecludes the use of mixed agonist oragonists in combination with otherdrugs. The Secretary has announcedplans to develop new rules specificallyfor partial agonist medications for thetreatment of opiate addiction (See 65 FR25894, May 4, 2000). Therefore, use ofthe term ‘‘agonist’’ is appropriate in thiscontext.

The use of ‘‘other drugs’’ (interpretedto mean non-narcotic substances) incombination with methadone andLAAM are not subject to the regulatoryrequirements of this rule.

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3. Several comments were submittedon the proposed definition of opiateaddiction. Some comments suggestedthat the definition should be revised toremove behavior-oriented concepts andrely on medical constructs only. Onecomment suggested substituting thedefinition of opiate addiction containedin the recent NIH consensus panelreport. The Secretary concurs, and hasrevised the definition of opiateaddiction to be more consistent with therecent NIH Consensus panel’srecommendations.

4. A few comments were concernedthat there would be only twoaccreditation bodies, CARF and JCAHO.In addition, these comments reflectconcern that accreditation would be anadditional requirement on top ofexisting FDA regulations.

As proposed in the July 22, 1999,notice (section 8.3(a)) any privatenonprofit organization, Stategovernmental entity, or politicalsubdivision thereof, capable of meetingthe requirements of subpart A is eligibleto apply to become an accreditationbody under the new rules. As discussedelsewhere in this final rule, some Stateauthorities have contacted SAMHSAand expressed interest in becoming anaccreditation body under subpart A. Inaddition, a number of non-governmentalentities have expressed similar interest.Accordingly, the Secretary believes thatthere will be more than twoaccreditation bodies that seek andobtain approval to become anaccreditation body under these rules.

The requirements for accreditationand SAMSHA certification under thisfinal rule will replace the requirementsfor FDA approval of OTPs underprevious regulations. The previousregulations in place under 21 CFR291.505 will be rescinded on March 19,2001.

5. The Secretary received aconsiderable number of diversecomments from State authorities, OTPs,and patients on the provision proposedunder section 8.3(a) that would permitStates to serve as accreditation bodiesunder the new rules. The preamble tothe July 22, 1999, notice emphasized theneed for States to consider serving asaccreditation bodies. This emphasis wasbased upon the recommendation in theIOM Report that strongly suggested thatthe Federal Government design aconsolidated inspection system thatreduces the burden on OTPs frommultiple (Federal, State, local)inspections.

State authorities provided a mixedresponse in their comments on thisissue. As discussed below, severalStates expressed an interest in becoming

accrediting bodies under the new rulesbut believed that they were ineligiblebecause they could not accredit 50 OTPsa year under proposed section 8.3. Onthe other hand, many States indicatedthat they were not interested inbecoming accreditation bodies, whileseveral indicated that they wereundecided and would await additionalinformation.

Comments from OTPs, for the mostpart, reflect a longstanding cooperativerelationship with State regulatoryauthorities. OTPs, in general, did notappear to oppose the concept of Stateauthorities serving as accreditationbodies under the proposed new system.Indeed, some OTPs, located withinStates that assess extensive licensingfees, commented that it would beimperative that States take on the roleof accreditation bodies under the newsystem in order to eliminate thefinancial impact of licensing andaccreditation fees.

Comments from patients on this issuesuggested caution. Many patients sensedthat State regulators would retain strict,‘‘process-oriented’’ regulations orphilosophies. These comments urgedthat if SAMHSA permitted States toserve as accreditation bodies then theagency should carefully monitoraccreditation standards and practices toassure that they conform with theFederal opioid treatment standards.

After considering the comments onthis issue, the Secretary is retaining theprovision that allows States to serve asaccreditation bodies under the newrules. The Secretary acknowledges thatmany States will choose not toparticipate as accreditation bodies.Some of these States already acceptaccreditation by recognizedaccreditation bodies for licensingpurposes. It is expected that moreStates, especially States with relativelyfew OTPs, will also choose to acceptaccreditation as meeting State licensurerequirements in time. Indeed, legislationenacted recently in New Hampshire toallow methadone maintenancetreatment incorporated a requirementfor CARF accreditation (Ref. 2). Finally,some States will apply accreditationreviews and findings to complementtheir licensing activities. The Secretaryrecognizes that the States’ role inadapting to the new system will changeover time as additional information onaccreditation is developed.

The Secretary believes that there areadequate safeguards to address patientconcerns about overly restrictive Stateregulations and oversight. Under section8.3(b)(3), SAMHSA will review eachapplicant accreditation body’s proposedaccreditation standards. As part of this

review, SAMHSA will determine theextent to which the accreditationstandards are consistent with theFederal opioid treatment standards. Inaddition, under section 8.5, SAMHSAwill evaluate periodically theperformance of accreditation bodies byinspecting a selected sample of theOTPs accredited by the accreditationbody. As part of this effort SAMHSAmay also consider follow-up inspectionsin cases where accreditation activitiesidentify public health, public safety,and patient care issues.

The Secretary continues to believe, asoutlined in the July 22 proposal, thatthere are benefits to States serving asaccreditation bodies under this rule.This feature provides the potential toreduce the overall number of OTPinspections. It also permits the use andapplication of the vast expertiseavailable within many State oversightagencies.

6. A number of State authorities andan accreditation body questioned therestriction under proposed section8.3(b)(3) that would requireaccreditation bodies to be able to surveyno less than 50 OTPs annually. Somecomments contend that this wouldunfairly and inappropriately excludesmaller States or States with fewer OTPsfrom participating. These commentssuggested that other requirementsshould be considered and applied or awaiver provision added. Oneaccreditation body commented thataccreditation bodies recognized by theHealth Care Financing Administrationare not subject to such arbitrarylimitations. Other comments suggestedthat the 50 survey per year minimumwas not necessary to achieve its statedpurpose—to ensure the quality ofaccreditation services and minimize thevariability of accreditation standards.

The Secretary concurs with thesecomments. The provisions of section8.3(b)(3) (submission and review ofproposed accreditation standards) andsection 8.5 (periodic evaluation ofaccreditation bodies) are adequate toenable SAMHSA to ensure the quality ofaccreditation services and minimize thepotential variability in accreditationstandards. Accordingly, section 8.3(b)has been modified to remove thisrequirement.

7. A few comments suggested thatState authorities and patient advocatesshould be permitted to participate in theapproval of accreditation bodies underthe new rules and in the accreditationprocess in general. These commentsbelieve that they can make substantialcontributions to the process.

The Secretary agrees that patients andState authorities can contribute

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substantially to the successful operationof the new system. State authorities andpatients have participated in thecommittees that have developedSAMHSA/CSAT’s AccreditationGuidelines. In addition, representativesfrom both these groups have served onthe Accreditation Subcommittee of theSAMHSA/CSAT National AdvisoryCouncil. Accreditation standardsinclude several provisions designed tosolicit and consider individual patientviews regarding treatment planning andother areas. Some, though not all,accreditation bodies also have patienthotlines that allow patients to conveyconcerns directly to accreditationbodies. Finally, SAMHSA and Stateauthorities will continue to consult andinteract under the new rules. TheSecretary believes that these measuresare adequate to assure the appropriatelevel of State authority and patientinput into the accreditation process.

8. Several comments addressedproposed section 8.3(b)(6), pertaining tothe qualifications of accreditation bodypersonnel and proposed section 8.4(h)on accreditation teams. One Stateauthority objected that the requirementthat there be a licensed physician on theaccreditation body staff was anunnecessary expense to accreditationbodies. Another commentrecommended that accreditation teamsshould include a physician certified fordispensing opioids. Some patientsadvocated that the accreditation teamshould include a current patient.

The Secretary believes therequirements for accreditationpersonnel and accreditation teams as setforth in the July 22, 1999, proposal aresufficient. It is not clear that every OTPwould benefit from having a physicianor opioid agonist patient on theaccreditation team. The Secretary hasreviewed the results of accreditationsurveys under the SAMHSA/CSATmethadone accreditation project. Basedon these reviews, the requirements setforth under section 8.4(h) are adequateto assure that accreditation bodiescarefully consider the qualifications ofaccreditation surveyors andaccreditation teams.

9. A considerable number ofcomments were submitted, mostly byState authorities, concerning theabsence of a definition for Stateauthority. These comments suggestedthat adding a definition for stateauthority could reduce confusion inStates that serve as accreditation bodies.In addition, these comments reflect abelief that this change would helpclarify the Federal-State consultationprocess set forth in the proposed rule.The Secretary agrees with these

comments and has added a definition ofState Authority. This definition tracksclosely with the definition contained inthe previous regulations under section21 CFR 291.505.

C. Subpart B—CertificationSubpart B establishes the criteria and

procedures for the certification of OTPs.This section also addresses theconditions for certification and theinteraction between the FederalGovernment and State authorities underthe new rules.

1. Many comments from Stateregulators noted that there was noreference to a requirement that OTPsobtain a license or permit from Statesbefore receiving certification from theFederal Government. These commentsreflect a concern that SAMHSA maycertify a program in a State where nomethadone authority exists, or withoutthe knowledge of the State authority.Other comments urged Federalcertification to pre-empt State licensing,noting that ‘‘initial State approval willremain a de facto requirement.’’

The Secretary believes that theconditions for certification as set forthin the July 22, 1999, proposal, includingthe provisions relating to Statelicensure, are adequate and appropriateto fulfill the objectives of this rule. TheSecretary’s role in the oversight ofnarcotic treatment is to set standards forthe appropriate use of narcotic drugs inthe treatment of addiction, and then toensure compliance with thosestandards. The States, on the otherhand, have a broader set ofresponsibilities, including regional andlocal considerations such as the numberand distribution of treatment facilities,the structural safety of each facility, andissues relating to the types of treatmentservices that should be available.Nothing in this part is intended torestrict State governments fromregulating the use of opioid drugs in thetreatment of opioid addiction. TheSecretary notes that many Statesexercise this authority by choosing notto authorize methadone treatment at all.

The Secretary does not believe thatOTPs will open and begin treatingpatients without State notification,review, and approval. The Secretary hasbeen careful to state throughout this rulethat OTPs (including medication units)must comply with all pertinent Stateand local laws as a condition of Federalcertification. As such, OTPs will also beresponsible for assuring that they havethe necessary approvals and licensure atthe State. Moreover, OTPs must obtainDEA registration prior to acceptingopioid addiction treatment drugs for thetreatment of opiate addiction. DEA

registration is explicitly contingentupon State authority approval.Importantly, as noted below, there willbe extensive consultation, coordination,and cooperation between SAMHSA andrelevant State authorities.

2. One State regulator requested thatthe regulation be modified at section8.11(c)(1) to add a requirement thatSAMSHA notify the State upon receiptof applications for certification as wellas approval and withdrawal. Thiscomment was based upon a concern thatprovisionally certified programs couldoperate without a State’s knowledge.

The Secretary agrees that it isimperative for States to be notified ofsignificant certification activities,including new program applications,program suspensions and withdrawals.SAMHSA intends to notify States of allsuch developments under theprovisions of section 8.11(c)(1). TheSecretary believes that the rules aresufficiently clear on this point.

3. Some State authorities suggestedrevising proposed section 8.11(h),which states that SAMHSA ‘‘may’’consult with State authorities prior togranting exemptions from a requirementunder sections 8.11 or 8.12.

Section 8.11(h) permits OTPs torequest exemptions from therequirements set forth under theregulation. This represents acontinuation of a long-standingprovision from the previous regulationunder 21 CFR 291.505. The Secretaryanticipates that most exemptionrequests under the new rule will be topermit variations from the treatmentstandards, including program-wideexemptions for medical maintenance.The Secretary agrees that it isappropriate and necessary to consultwith State authorities on requests forvariations from existing standards.Accordingly, section 8.11(h) is revisedto require consultation with the Stateauthority prior to granting anexemption.

4. Several comments from patientssuggested that Federal regulationsshould prevent States from imposingadditional regulatory requirementsbeyond the Federal regulations. Many ofthese comments contend that Stateregulations prevent treatmentexpansion, hinder accountability forquality treatment, limit patient access,and lead to patient abuses.

As noted above, the Secretaryacknowledges the authority within Stategovernment to regulate the practice ofmedicine. This rule does not pre-emptStates from enacting regulationsnecessary to carry out these importantresponsibilities.

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Many State regulations closelyresemble the previous Federalregulations under 21 CFR 291.505. Inaddition, many States are currentlyreevaluating their regulations todetermine if modifications are necessaryto reflect the changes in Federal rules.The Secretary encourages States toconsider the new information onchanges in the opioid addictiontreatment field, including phases oftreatment, measuring accountability forimproving the quality of patient care,and modern medication dosingpractices, as States proceed in revisingtheir regulations.

The Secretary also invites States tocontinue to enhance their partnershipwith Federal authorities in this area. Asnoted above, the final rule includes anew feature—the opportunity for Statesto serve as accreditation bodies. Thisnew activity adds to existingpartnership opportunities, such as theparticipation in the SAPT Block Grantprogram and its related technicalassistance program. The Secretary hopesthat these actions collectively willcontinue the regulatory reform startedwith the July 22, 1999, proposal.

5. A few comments expressed concernabout proposed section 8.11(e), whichpermits provisional certification for oneyear, while a program obtainsaccreditation. These comments believethat one year was ‘‘too long for aprogram to go without accreditation.’’

The Secretary believes that themaximum 1-year term (not includingthe 90-day extension allowed undersection 8.11(e)(2)) for provisionalcertification is reasonable andcustomary with accreditation in otherareas of healthcare. The purpose of thisprovision is to permit new OTPs toinitiate operations and generate patientrecords to aid in the accreditationapplication, survey, and review process.It should be noted that OTPs will besubject to SAMHSA, DEA, and Stateoversight during the tenure ofprovisional accreditation. These OTPsmust comply with Federal opioidtreatment regulations and are subject tocompliance actions at any time.

6. Section 8.11(i)(2) proposed thatcertification as an OTP would not berequired for the maintenance ordetoxification treatment of a patientwho is admitted to a hospital or long-term care facility for the treatment ofmedical conditions other thanaddiction. One comment noted that, aswritten, patients admitted to hospitalsfor cocaine or alcohol addiction wouldnot be eligible for treatment under thisprovision. The comment suggested thatadding the word ‘‘opioid’’ before‘‘addiction’’ would help to clarify this

issue. The Secretary concurs and thesection 8.11(i)(2) has been changed toreflect this change.

D. Subpart B—Treatment Standards1. A number of comments were

submitted on proposed section 8.12 ingeneral. These comments stated that theFederal Opioid Treatment standards arevague and lack specificity. As such,these comments contend that thestandards are unenforceable asregulations. One comment suggestedthat the SAMHSA/CSAT AccreditationGuidelines be incorporated asregulations.

The Secretary believes that theFederal Opioid Treatment Standards areenforceable, and do not need to bemodified to accomplish their purposeunder the new rules. The July 22, 1999,proposal noted that in the past, HHS hasattempted to write all facets oftreatment, including required services,into regulation. In addition, theproposal acknowledged that it is nowaccepted that (a) different patients, atdifferent times, may need vastlydifferent services, and (b) the state of theclinical art has changed, to reflectscientific developments and clinicalexperience, and is likely to continue tochange and evolve as our understandingof more effective treatment methodsincreases. Accordingly, the Secretaryproposed a more flexible approach witha greater emphasis on performance andoutcome measurement. With guidancefrom SAMHSA, the accreditation bodieswill develop the elements needed todetermine whether a given OTP ismeeting patient needs for requiredservices. SAMHSA will review theseelements as part of the accreditationbody’s initial and renewal applicationsto ensure that accreditation bodies haveincorporated the Federal opioidtreatment standards into theiraccreditation elements. SAMHSA willalso review accreditation body elementsto ensure that the elements do notexceed Federal expectations in terms ofopioid agonist treatment. Incorporatingaccreditation guidelines into regulationswould subvert this approach.

As noted in the July 22, 1999,proposal, the Secretary believes that thestandards are ‘‘enforceable regulatoryrequirements that treatment programsmust follow as a condition ofcertification (64 FR 39810, July 22,1999).’’ While the new regulationsincrease the flexibility and clinicaljudgement in the way OTPs meet theregulatory requirements, they are setforth under section 8.12 as the services,assessments, procedures, etc., that OTPs‘‘must’’ and ‘‘shall’’ provide. As such,the new standards are as enforceable as

the previous regulations under 21 CFR291.505. OTPs that do not substantiallyconform with the Federal OpioidTreatment standards set forth undersection 8.12 will risk losing SAMHSAcertification.

2. One comment recommended thatproposed section 8.12(b) should bemodified to require a standard thatOTPs should have adequate facilities.The comment stated that this provisionexisted in the previous regulation. TheSecretary agrees and has added arequirement that OTP’s must maintainadequate facilities. The Secretary notes,however, that SAMHSA/CSATaccreditation guidelines andaccreditation standards used in theSAMHSA accreditation impact study,address the adequacy of the OTP’sfacility. These accreditation standards,in conjunction with treatmentoutcomes, will help determine whetherfacilities are adequate under the newrules.

3. One comment addressed proposedsection 8.12(b), stating that rules shouldexpressly require compliance with civilrights laws, not just ‘‘pertinent’’ Federallaws. As such, the comment suggeststhat the standards should requiredetailed patient grievance procedures,including appeals to neutral parties. TheSecretary believes that it is notnecessary to modify the rule to reflectcivil rights laws specifically. These lawsare included under the requirement aswritten. In addition, SAMHSA/CSATAccreditation Guidelines, as well as theaccreditation standards developed fromthem include provisions for acceptingand acting upon patient grievances.

4. A number of respondentscommented on proposed section 8.12(d)which addresses OTP staff credentials.Under the July 22, 1999, proposal, theSecretary proposed that each personengaged in the treatment of opiateaddiction must have sufficienteducation, training, or experience or anycombination thereof, to enable thatperson to perform the assignedfunctions. Further, all licensedprofessional care providers mustcomply with the credentialingrequirements of their professions. Theproposal encouraged, but did notrequire, that treatment programs retaincredentialed staff.

Some comments requested that thisstandard be clarified to requireAmerican Society of AddictionMedicine (ASAM)-certified medicalprofessionals. Another commentquestioned whether personnel had to belicensed in the State where thetreatment program is located. Anothercomment from a State Authority,recommended that the regulations

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specify the license, training, experience,as well as the number of licensedcounselors in a program, including aminimum counselor-to-patient ratio. Onthe other hand, an OTP medical directorcommented that none of the citedcredentials ‘‘conferred competence indealing with opioid dependent patients,per se.’’ According to this comment,SAMHSA/CSAT should instead developcurricula for medical directors and othercare givers.

Except for the requirements of section8.12(h), which relate to thequalifications for practitioners whoadminister or order medications, theSecretary does not believe that it isappropriate to further prescribe thequalifications for health professionals inthis regulation. Under sections 8.12(b),(d), (e), (f) services must be provided byprofessionals qualified by education andtraining. The Secretary does not believethat one credentialing organizationshould be specified as a requirement forqualifications. Instead, the Secretaryintends to rely on guidelines andaccreditation standards together withpatient outcome assessments todetermine the adequacy of training andeducation level of professionals inOTPs. SAMHSA/CSAT is activelydeveloping model training curricula inthis area.

5. A few comments suggested that theregulations specify the outcomemeasures for quality assessment plansunder section 8.12(c)(1). Similarly, somecomments suggested that diversioncontrol plans, which OTPs are requiredto develop under section 8.12(c)(2),should also be spelled out inregulations.

The Secretary believes that theregulation as proposed providessufficient detail on outcome measuresand diversion control plans. In keepingwith the intent of the regulation reform,these general requirements areelaborated in best-practice guidelinesand in ‘‘state-of-the-art’’ accreditationstandards. Indeed, following a review ofthe accreditation standards that arebased upon SAMHSA/CSAT’s opioidtreatment accreditation guidelines, theSecretary has determined that they areadequate to ensure that OTPs will beable to develop meaningful outcomeassessment and diversion control plans.In addition, these SAMHSA/CSATaccreditation guidelines andaccreditation standards reflect the latestresearch findings in this area. Unlike theFederal regulations, these guidelinesand standards will be updatedperiodically to reflect new research andclinical experience.

6. The Secretary received aconsiderable number of comments on

the proposed definition and thestandards for short-and long-termdetoxification treatment. Most of thesecomments suggested that the word‘‘detoxification’’ is a pejorative non-medical term and does not constitutetreatment, because few, if any, patientscan be stabilized in such a short periodof time. These comments suggested thatall references to detoxification shouldbe deleted from the regulations, or atleast renamed.

These comments fail to recognize thedistinction between opiate dependence,for which detoxification treatment isappropriate, and opiate addiction, forwhich maintenance treatment isappropriate. The Narcotic AddictionTreatment Act of 1974 (NATA) andregulations have long recognized thesedistinctions. While a majority of theavailable treatment research, includingrecent studies, concludes thatmaintenance treatment is much moreeffective than detoxification regimens,the Secretary believes that it is stillnecessary to retain distinct standards formaintenance and detoxificationtreatment (Ref. 3).

7. Several comments were submittedin response to the Secretary’s specificrequest for comments on proposedsection 8.12(e)(4) which set forthminimum requirements fordetoxification treatment. The July 22,1999, proposal retained the requirementfrom the existing regulation that ‘‘apatient is required to wait no less than7 days between concluding onedetoxification episode before beginninganother.’’ Essentially, while sympatheticto the need for limits on detoxificationtreatment, all the comments on this itemopposed continuing any waiting periodbetween detoxification episodes. Theserespondents believe that seven days is‘‘artificial * * * or more time than isneeded.’’ In addition, these commentsindicate that OTPs often request and aregranted exemptions from the waitingperiod requirement under the existingregulation, creating an unnecessarypaperwork burden for OTPs, as well asState and Federal regulators. Instead,the comments suggested a limit on thenumber of unsuccessful detoxificationepisodes in one year before the patientis assessed for opioid agonistmaintenance or other treatment. Inaddition, these comments recommendedthat an unsuccessful detoxificationattempt be defined to include anyrelapse to abuse.

The Secretary agrees with therecommendations that the intent of therestrictions on detoxification can beaccomplished without a mandated timeinterval between detoxificationadmissions. The standards for

detoxification treatment set forth undersection 8.12(e)(2) and (4) have beenrevised to state that patients with two ormore unsuccessful detoxificationepisodes within a 12-month period mustbe assessed by the OTP physician forother forms of treatment. This change isconsistent with SAMHSA/CSATaccreditation guidelines which alsoelaborate on unsuccessful detoxificationtreatment attempts.

8. A considerable number of diversecomments addressed proposed section8.12(f) relating to required services. Thissection of the July 22, 1999, proposalrequires that ‘‘adequate medical,counseling, vocational, educational andassessment services are fully andreasonably available to patients enrolledin an OTP.’’

Two comments stronglyrecommended that the regulationrequire integrated, simultaneoustreatment by specially cross-trainedstaff, for co-occurring opioid treatmentand mental illness. These respondentsbelieve that integrated services forpersons with an addiction(s) and apsychiatric disorder are crucial. Thesedually-diagnosed patients represent 50–80 percent of substance dependentpopulations.

The Secretary agrees with theimportance of providing adequateintegrated services for opiate-addictedpatients who also suffer frompsychiatric disorders. Indeed, theSAMHSA/CSAT AccreditationGuidelines, along with the accreditationstandards developed by CARF andJCAHO all address the need to evaluatepatients for co-occurring illnesses,including mental illness. CARF OpioidTreatment Program AccreditationStandards state that services for co-occurring illness should be provided onsite or by referral. However, the samestandards note that ‘‘coexistingconditions, especially in persons fromdisenfranchised populations, are mosteffectively treated at a single site.’’ TheSecretary takes note that theseprovisions for co-occurring disordersunder these new rules will be a vastimprovement over the previousregulatory system, which did notaddress co-occurring opiate addictionand psychiatric disorders at all. Assuch, under the new rules, patients’access to effective treatment for co-occurring disorders will be enhancedsubstantially. However, the Secretarybelieves that it would be prohibitivelyexpensive to require every OTP to hireand retain specialists in the treatment ofco-occurring disorders.

Other comments on this section statedthat the regulations should specify aschedule for services. Some comments

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recommended that the regulationsrequire OTPs to document that patientsactually receive services when they arereferred to off-site providers. Othercomments suggested that accreditationbodies should monitor the extent towhich services are provided as part oftheir periodic onsite surveys. Still othercomments, mostly from patients,suggested the requirement for servicesbe eliminated, maintaining thatmedication is all they needed.

The Secretary believes that therequirements for services as stated inthe July 22, 1999, proposal, togetherwith the accreditation process, provideadequate assurance that patientsenrolled in OTPs receive the servicesthat they have been assessed to need.The July 22, 1999, proposal emphasizedthe need for these services as anessential part of treatment. However, inshifting to an accreditation approachwith an emphasis on performanceoutcomes, the Secretary was no longerattempting to ‘‘write all facets of theserequired services into regulation.’’ OTPsmust initially and periodically assesseach patient and ensure that adequateservices are available to patientsdetermined to need them. SAMHSA/CSAT Accreditation Guidelines andaccreditation standards will elaborateon the standards for services. OTPs willbe accountable through theaccreditation process to assure thatpatients receive the appropriate servicesthey need for successful treatmentoutcomes; for some patients, medicationservices may be sufficient to producepositive outcomes.

9. A number of respondents submittedcomments on proposed section8.12(f)(2), which requires a completemedical examination within the first 30days following admission. Some ofthese comments noted that thisprovision, as proposed, permittedpatients to enter treatment while tests,some of which required several days,are completed. Others commented thatthe 30 days was too long to wait for amedical exam to be completed, notingthat information from the exam iscrucial to the first few days of treatment.Finally, some comments suggested thatregulations should specify the contentsof the medical exam.

The intent of proposing 30 days forthe completion of the physical examwas to allow patients into treatmentwhile OTPs wait for the results ofserology and other tests that require, insome cases, several days to complete.Section 8.12(f)(2) has been revised toclarify the requirement for a physicalexam upon admission, with serologyand other tests results completed w/in14 days. The Secretary does not agree

that regulations should specify thecontents of the medical examination.Instead, the Secretary believes thataccreditation guidelines should expressthe state-of-the-art content for a medicalexam appropriate for the treatment ofopiate addiction.

10. The July 22, 1999, notice proposedthat OTPs conduct at least eight randomdrug abuse tests per year for eachpatient. Many comments suggested thatthe Federal standards specify morefrequent drug abuse tests, includingweekly testing, to balance the moreflexible proposed take-home schedule.Other comments suggested that Federalregulations should specify measures toprevent adulteration. On the other hand,some comments suggested that quarterlydrug abuse testing is appropriate.Moreover, one comment recommendedsubstituting an ‘‘honor system’’ becausepatients can corrupt the testing processand falsify results.

After considering the comments onthis issue, the Secretary is retaining therequirement for a minimum of eightrandom drug abuse tests per year formaintenance treatment. The Secretarybelieves that this is an adequate andbalanced standard for drug abusetesting. There is extensive discussion ondrug abuse testing issues in theSAMHSA/CSAT TreatmentImprovement Protocols and theSAMHSA/CSAT AccreditationGuidelines. In addition, these guidelineselaborate on measures to address thecorruption and falsification of results.Finally, as the Federal standard is aminimum, OTPs can require morefrequent tests if desired.

11. The Secretary received manycomments on proposed section8.12(g)(2) which requires OTPs todetermine and document that patientsare not enrolled in other programs. Mostrespondents question how suchdeterminations could be made withouta patient registry. One comment statedthat multiple enrollments areattributable to inadequate medicationdosing practices.

The July 22, 1999, proposal retainedthe provisions relating to multipleenrollments from the previousregulations under 21 CFR 291.505. Inproposing to retain the requirement, theSecretary noted that there have beencases of patients enrolling in more thanone treatment program; however, theextent of this practice is undeterminedbut not considered to be widespread.The intent of this provision is for OTPsto make a good faith effort, usingavailable resources and mechanisms toascertain whether or not a prospectivepatient was currently enrolled inanother OTP. Some individual States

with OTPs concentrated within acommunity have established a patientregistry and require OTPs to report newpatients and patients who havediscontinued in treatment. In otherjurisdictions, patient registries aredeveloped and maintained voluntarilyby OTPs. OTPs also often contact otherOTPs in the vicinity to determine if thepatient is currently enrolled in an OTP,or they ask the patient. If used, thesemechanisms must be used inaccordance with the provisions at 42CFR 2.34, regarding disclosures toprevent multiple enrollments. TheSecretary acknowledges that none ofthese mechanisms can determine withcomplete certainty whether or not apatient is enrolled in more than oneOTP. Accordingly, the Secretary expectsthat OTPs will document in eachpatient’s record that the OTP made agood faith effort to review whether ornot the patient is enrolled in any otherOTP. Section 8.12(g)(2) has been revisedaccordingly.

12. The Secretary received manycomments on proposed section 8.12(j),relating to interim methadonemaintenance. Most of these commentswere from patients who suggestedinterim maintenance as a model for longstanding patients who have beenstabilized in treatment. As such, thesecomments suggested that the term forinterim methadone maintenance beextended beyond 120 days.

These comments reflect amisunderstanding of interim methadonemaintenance. Interim methadonemaintenance was mandated by theADAMHA Reorganization Act of 1992as a measure to address shortages intreatment capacity and documentedwaiting lists (Pub. L. 102–321, See also58 FR 495, January 5, 1993). Thelegislation included several restrictionswhich were incorporated and retainedinto Federal regulations. Although veryfew programs have applied forauthorization to provide interimmethadone maintenance, the Secretarydoes not at this time believe it isnecessary or appropriate to change thestandards. Instead, as discussedelsewhere in this notice, the Secretarybelieves that medical maintenanceprovides a more reasonable approach forexpanding treatment capacity.

13. The Secretary received commentson proposed section 8.11(h), whichprovides for exemptions from treatmentstandards or certification requirements.One comment suggested that theexamples in the previous regulation forexemptions, be retained in the final newregulations. The comment suggests thatthis would encourage individualphysicians, pharmacists, or both to

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provide methadone treatment in ruralareas where methadone treatment isscarce or unavailable. Another commentsuggested that SAMHSA streamline theexemption process and do more topublicize the availability of suchregulatory options. The Secretaryaccepts both of these suggestions, andsection 8.11(h) has been revisedaccordingly. In addition, SAMHSA hasalready taken steps to streamline theexemption process and publicize theavailability of certain exemptions (Ref.4).

14. Most comments stronglysupported the provisions in proposedsection 8.12(h)(3)(i) which permitsOTPs to use solid dosage forms. Somepatients reported spoilage anddecomposition problems with 14-daysupplies of liquid dosage form. Othercomments suggested that the use ofsolid medication will reduce treatmentcost modestly by eliminating the needfor dosage bottles for solutions. TheSecretary agrees that permitting OTPs touse solid medication will reducetreatment costs and increase treatmentconvenience to patients.

15. The Secretary received manycomments on proposed section8.11(h)(3)(iii) that would have requiredthe program physician to justify in thepatient record all doses above 100 mg.Most comments viewed thisrequirement as an inappropriate ‘‘valuejudgement’’ that hampers clinicaljudgement. The Secretary agrees that therequirement to justify a dose above 100mg, which is a modification of arequirement under the previousregulation, is not necessary to reducethe risk of medication diversion.Accordingly, this requirement has beeneliminated from the final rule.

16. The Secretary specificallyrequested and received comments onproposed changes to the requirementsunder section 8.12(i) pertaining tomedications dispensed for unsuperviseduse (hereinafter ‘‘take-homes’’). The July22, 1999, proposal set forth four optionsfor addressing take-homes. Theseoptions ranged from retaining theprevious requirements to a schemebased on a maximum dose. Optionnumber 2 was discussed as the optionpreferred by HHS and endorsed by DEA.This option resembles the requirementunder the previous regulations andretains the 8-point take-home criteria.However, option number 2 permittedpatients in stable treatment for one yearto receive up to a 31-day supply ofmedication, while the previousregulation included a maximum take-home supply of 6 days.

Most comments supported proposedoption 2, with modifications. In

supporting option 2, current patientsstated that less frequent clinicattendance will make treatment muchmore convenient. In addition, Option 2will eliminate travel hardships andfacilitate employment commitments,ultimately increasing retention intreatment and rehabilitation. Option 1,which encompassed the take-homeschedule from the previous regulation,was viewed by many comments as toorestrictive. Many comments opposedoption 3, which proposed a set 2-weekmaximum milligram amount for take-homes, because it unfairly penalizedpatients receiving higher doses.

On the other hand, a form lettercirculated and submitted by severaltreatment programs stated that nopatients should be eligible for a 31-daytake-home supply. According to thesecomments, all patients must report toclinics often so that their rehabilitationcan be monitored appropriately. Inaddition, these comments stated thatallowing any patient a 31-day take-homesupply presents an unacceptable risk ofdiversion.

The Secretary does not agree withthese comments. Indeed, there isconsiderable evidence that manypatients can responsibly handlesupplies of take-home medicationsbeyond the 6-day maximum allowedunder the previous regulations. Inaddition, FDA has permitted hundredsof patients to receive monthly take-home supplies of methadone throughexemptions or Investigational New DrugApplications. These investigations havebeen analyzed and reported in scientificliterature and indicate that patientssuccessfully continue in rehabilitation(Ref. 5). Moreover, these cases indicatethat rehabilitation is enhanced throughthese ‘‘medical maintenance’’ models.Accordingly, and in response to anincreased interest in this issue, FDA andSAMHSA/CSAT issued a ‘‘DearColleague’’ letter on March 30, 2000,that advised the field on procedures forobtaining OTP exemptions for medicalmaintenance, which include a provisionfor up to a 31-day supply of take-homemedication (Ref 4).

The Secretary notes that manycomments provided suggestions onrefining the basic schedule for take-home eligibility outlined in proposedoption 2. For example, many commentssuggested that one year of stabletreatment was still too short a period oftime to evaluate whether patients canresponsibly handle a 31-day supply oftake-home medication. These commentssuggested an interim step that permits a14-day take-home supply after one yearof stable treatment before a patient iseligible for a 31-day supply.

The Secretary concurs with thesecomments. The 2-year time in treatmentrequirement is more consistent with thestudies and exemptions for medicalmaintenance granted to date under theprevious rules. In addition, thisschedule is more consonant with theschedule set forth in the SAMHSA/CSAT Accreditation Guidelines and theaccreditation body standards.Accordingly, section 8.12(i)(3) has beenrevised to reflect a 14-day take-homestep after one year of stable treatmentand to reflect that patients are eligiblefor a take-home supply up to 31 daysafter two years of stable treatment. Thelanguage in other parts of section8.12(i)(3) has been modified slightly forclarity to lengthen the duration of thesteps within the first year of treatment,and to remove some requirements forobserved ingestion.

17. Comments overwhelminglysupported the proposal to permit take-home use of LAAM and suggest that theSecretary apply the same schedule asmethadone, e.g. option 2. A commentfrom a practitioner who has treated over500 patients, stated that patients dislikebeing switched from LAAM tomethadone when necessary for travelpurposes. Most comments suggestedthat diversion of LAAM is no morelikely than the diversion of methadonewhich generally is not problematic. Onecomment submitted the results of a 149-patient study on LAAM take-home use.Patients were randomized into take-home and clinic only groups. As part ofthe study, 545 take-home doses ofLAAM were distributed to patients, andpatients were subject to random‘‘callbacks.’’ There was no evidence oftampering, diversion, or interest inobtaining LAAM take-home suppliesillicitly. In addition, there were nodifferences between the two groups inthe measured outcome variables. Theinvestigator concluded that methadoneand LAAM should be subject to thesame take-home requirements. TheSecretary concludes that LAAM shouldbe available for take-home use underthis rule.

18. A comment submitted by aphysician discussed his successfulexperience using LAAM fordetoxification treatment, finding LAAMto be superior to methadone fordetoxification with some patients. Thecomment suggested that the regulationsshould be modified to permit the use ofLAAM for detoxification.

Although previous Federal Registernotices may have suggested that LAAMwas not available for use indetoxification treatment (58 FR 38704,July 20, 1993), the July 22, 1999,proposal does not prohibit the use of

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methadone or LAAM for detoxificationtreatment. Indeed, the current FDAapproved labeling for LAAM discussesand provides guidance on withdrawingpatients from LAAM therapy:

ORLAAM is indicated for the managementof opiate dependence * * * There is alimited experience with detoxifying patientsfrom ORLAAM in a systematic manner, andboth gradual reduction (5 to 10% a week) andabrupt withdrawal schedules have been usedsuccessfully. The decision to discontinueORLAAM therapy should be made as part ofa comprehensive treatment plan.

The Secretary believes that theregulations are adequately clear on thispoint.

19. A few respondents commentedupon the proposed implementation planand whether OTPs could be expected tocomply with the timetables forachieving accreditation. Underproposed section 8.11(d), treatmentprograms approved under the previousregulations are deemed certified underthe new rules. This ‘‘transitionalcertification’’ would expire on June 18,2001 unless the OTPs certify with awritten statement signed by the programsponsor that they will apply foraccreditation within 90 days of the dateSAMHSA approves the firstaccreditation body. Transitionalcertification, in that case, will expire onMarch 19, 2003. SAMHSA may extendtransitional certification on a case-by-case basis for up to one year undercertain conditions. The commentsquestioned whether SAMHSA hadempirical evidence that OTPs couldmeet this timetable.

The Secretary believes that thetimetables proposed in the July 22,1999, notice remain reasonable. Asignificant number of OTPs havealready had experience withaccreditation. This includes programslocated in Department of VeteransAffairs Medical Centers, as well as OTPslocated in the several States that requireaccreditation of OTPs (Maryland,Indiana, North Carolina, Georgia, SouthCarolina, and Michigan). Moreover, asdiscussed previously, as part ofSAMHSA/CSAT’s accreditationimplementation plan, two accreditationbodies conducted accreditation surveysof OTPs and accredited over 50 OTPs injust a few months. SAMHSA/CSAT hasplanned additional training andtechnical assistance to enable OTPs tounderstand and comply with the newregulations. In addition, the regulationshave been streamlined with fewerreporting and recordkeepingrequirements. OTPs have had ampleopportunity to prepare for this finalrule, and the SAMHSA/CSATAccreditation Guidelines as well as the

CARF and JCAHO accreditationstandards have been widely availablefor years. Taken together, these factorsprovide the Secretary with reasonableconfidence that OTPs can apply for andachieve accreditation within two yearsfrom the effective date of this rule.

The Secretary is sensitive to concernsabout OTPs contacting accreditationbodies and scheduling accreditationreviews in a convenient manner.Therefore, while not changing thetimetables for achieving accreditationunder the final rule, the Secretary hasmodified section 8.11(d) to state thatprograms will agree to apply foraccreditation within 90 days from thedate SAMSHA announces the approvalof the second accreditation body. TheSecretary believes that tying thiscertification for OTPs to apply from thedate SAMHSA announces the approvalof the first accreditation body to the dateSAMHSA announces approval of thesecond accreditation body will facilitateOTPs contacting and achievingaccreditation under the final rule.

20. A few comments requested thatOTPs that have been previouslyaccredited by JCAHO and CARF shouldbe ‘‘grandfathered’’ somehow under thenew final regulations.

There are no provisions in the finalrule to accept accreditation byaccreditation bodies that have not beenapproved by SAMHSA under section8.3(d). These accreditation bodies didnot develop and apply accreditationstandards that were based upon theopioid agonist treatment standards setforth under section 8.12. SAMHSA,however, will consider on a case-by-case basis, whether OTPs that achievedaccreditation under the SAMHSA/CSATimplementation initiative can beexempted from re-accreditation underthis final rule, pursuant to section8.11(h).

E. Subpart C—Procedures for Review ofSuspension or Proposed Revocation ofOTP Certification, and of AdverseAction Regarding Withdrawal ofApproval of an Accreditation Body

1. One comment recommended thatsubpart C should be revised to adddiscovery provisions. This would enableOTPs to obtain crucial information onhow ‘‘accreditation bodies conductedtheir investigation.’’ The Secretarybelieves that the provisions of subpart Athat require that accreditation bodieshave appeals procedures in theiraccreditation decision-making process isadequate to assure that OTPs can obtainthe information they need onaccreditation activities.

2. One comment suggested thatsubpart C should be revised to allow

applicant OTPs to appeal decisions todeny approval of an initial application.The Secretary does not agree and pointsout that OTPs will be able to appealdenials of accreditation by accreditationbodies under § 8.3(b)(4)(vii).

3. Response times in § 8.26(a), (b) and(c) have been lengthened, as have theoral presentation timeframes in§ 8.27(d), and expedited procedures in§ 8.28(a) and (d).

F. Conclusion and Delegation ofAuthority

After considering the commentssubmitted in response to the July 22,1999, proposal, along with theinformation presented during theNovember 1, 1999, Public Hearing, theSecretary has determined that theadministrative record in this proceedingsupports the finalization of new rulesunder 42 CFR part 8.

In a notice to be published in a futureissue of the Federal Register, theSecretary will announce the delegationof authority to the Administrator ofSAMHSA, with the authority toredelegate, responsibility for theadministration of 42 CFR part 8.

III. Analysis of Economic ImpactsThe Secretary has examined the

impact of this rule under ExecutiveOrder 12866. Executive Order 12866directs Federal agencies to assess allcosts and benefits of available regulatoryalternatives and, when regulation isnecessary, to select regulatoryapproaches that maximize net benefits(including potential economic,environmental, public health and safety,and other advantages, distributiveimpacts, and equity). According toExecutive Order 12866, a regulatoryaction is ‘‘significant’’ if it meets anyone of a number of specified conditions,including having an annual effect on theeconomy of $100 million; adverselyaffecting in a material way a sector ofthe economy, competition, or jobs; or ifit raises novel legal or policy issues.While this rule is not a significanteconomic regulation, the Secretary findsthat this rule is a significant regulatoryaction as defined by Executive Order12866. As such, this rule has beenreviewed by the Office of Managementand Budget (OMB) under the provisionsof that Executive Order. In addition, ithas been determined that this rule is nota major rule for the purpose ofcongressional review. For the purpose ofcongressional review, a major rule isone which is likely to cause an annualeffect on the economy of $100 million;a major increase in costs or prices;significant effects on competition,employment, productivity, or

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innovation; or significant effects on theability of U.S.-based enterprises tocompete with foreign-based enterprisesin domestic or export markets.

A. IntroductionAs noted in the July 22, 1999,

proposal, approximately 900 OTPsprovide opioid agonist treatment toapproximately 140,000 patients in theU.S. For almost 30 years, FDA hasapplied process-oriented regulationswith periodic inspections to approveand monitor these OTPs. This final ruleestablishes an accreditation-basedregulatory system, administered bySAMHSA, to carry out theseresponsibilities. In addition, this finalrule includes changes that will make theregulations more flexible, and providethe opportunity to increase treatmentcapacity. OTPs will incur additionalcosts under the new accreditation-basedsystem, but these additional costs aremodest, and the Secretary believes areoffset by benefits set forth under thenew rules.

The additional costs under these newrules are attributable to the costs ofaccreditation. FDA did not assess feesfor inspections under the previousregulations. Under the new rules,private not-for-profit accreditationbodies will assess accreditation surveyfees, and if necessary, reinspection fees.The July 22, 1999, proposal estimatedthat the direct and indirect costs ofaccreditation at $4.9 million per year.These annual cost equal approximately$5,400 per facility and $39 per patient.The cost estimates were based ondiscussions with three accreditationbodies. Overall, the net costs of the newsystem over the existing FDA system,factoring in SAMHSA’s estimatedannual oversight costs of $3.4 million,was $4.4 million. The July 22, 1999,proposal noted that additionalinformation on accreditation costswould be derived from SAMHSA/CSATongoing accreditation implementationproject and requested specificcomments on the estimates provided.

As discussed above, although anumber of comments submitted inresponse to the July 22, 1999, proposalpredicted that accreditation costs couldbe higher, these predictions were basedupon accreditation experiences in thepast, not associated with the specificaccreditation standards set forth underthe new system. The results fromapproximately 50 accreditation surveysunder the SAMHSA accreditationimpact study suggest that the costs, asestimated in the July 22, 1999, proposal,are reasonably accurate.

The July 22, 1999, proposal discussedthe benefits of the proposed rule in

terms of the advantages of accreditationand in terms of relapse rates as afunction of retention in treatment.Although difficult to quantify, theSecretary believes that the accreditation-based system will provide morefrequent quality surveys of OTPs andallow greater flexibility in the deliveryof opioid treatment. In addition,patients have commented that theincreased flexibility of the newregulations, particularly in thestandards for medications dispensed forunsupervised use, will increase patientconvenience, increase patientsatisfaction, and increase patientretention in treatment. Importantly,changes in the regulations will facilitateand expand medical maintenancetreatment freeing resources to expandtreatment capacity. As noted in the July22, 1999, proposal, increasing retentionin treatment and increasing the numberof patients in treatment will lead todecreases in mortality and morbidityassociated with opiate addiction,decrease health expenditures, anddecrease criminal activity. Thesebenefits are likely to be significantlygreater than the costs of these newregulations.

B. Small Entity AnalysisThe Regulatory Flexibility Act (RFA)

requires agencies to analyze regulatoryoptions that would minimize anysignificant impact of a rule on asubstantial number of small entities.SAMHSA included such an analysis inthe July 22, 1999, proposal.

1. Description of ImpactThe July 22, 1999, proposal provided

an extensive description of the industry,and concluded that, although theregulations were streamlined under theproposal with fewer forms and reportingrequirements, the proposed ruleconstituted a significant impact on asubstantial number of small entities.This impact is attributable to therequirement that all OTPs, regardless ofsize, must be accredited and maintainaccreditation in order to continue totreat patients. Overall, the July 22, 1999,proposal estimated that the cost perpatient for a ‘‘small’’ OTP (defined as anOTP treating 50 or fewer patients)would increase slightly more than theindustry average ($50 compared to $39).

2. Analysis of AlternativesThe July 22, 1999, notice included a

brief discussion of alternatives to theproposed accreditation-based regulatoryscheme. In the analysis set forth initiallyin the July 22, 1999 notice, theDepartment discussed but dismissed thealternative of continuing the existing

direct, FDA monitored, regulatorysystem because of the findings andcriticisms of that system identified inthe Institute of Medicine Report andelsewhere. In addition, the alternative ofallowing self-certification wasdiscussed, but rejected due to concernsabout diversion and insufficientenforceability.

The preamble to the proposed rulealso included a brief discussion ofalternatives that would minimize theeconomic impact of the new regulationson small businesses and other smallentities. For example, the noticediscussed the alternative of exemptingsmall facilities from some requirements.It was also noted that small facilitiescould seek arrangements with largerfacilities that could lower costs witheconomy-of-scale features.

The issues in this initial analysis werehighlighted for specific comment, andthe notice itself was sent to every OTPidentified in the FDA inventory ofapproved programs. Except to say thatsmall programs should not have to closeunder the new rules, or that smallprograms should be exempt fromaccreditation, very few commentsaddressed the issue specifically, orprovided information on alternatives.Therefore, this initial analysis does notrequire changing and is adopted as thefinal regulatory flexibility analysis.

3. Response to Comments From SmallEntities

These issues were highlighted forspecific comment, and the notice itselfwas sent to every OTP identified in theFDA inventory of approved programs.Except to say that small programsshould not have to close under the newrules, or that small programs should beexempt from accreditation, very fewcomments addressed the issuespecifically, or provided information onalternatives.

As discussed above, SAMHSA hasevaluated the results of accreditationsurveys of OTPs conducted pursuant tothe proposed Federal opioid treatmentstandards. As such, SAMHSA has abetter understanding of howaccreditation will work in both largeand small OTPs. Moreover, SAMHSAhas provided technical assistance toparticipating programs to help themachieve accreditation. SAMHSA expectsto continue providing technicalassistance to programs during and afterthe transition to the new system.

The accreditation-based system, thesubject of these new rules, includesflexibility measures for small OTPs. TheSecretary anticipates that there will bea number of approved accreditationbodies to choose from, including those

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that will adjust accreditation fees on asliding scale tied to the patient census.In addition, SAMHSA will retain theauthority to certify programs withoutaccreditation and could apply thisprovision, if necessary, to addressburdens to OTPs with low patientcensuses. SAMHSA prefers this case-by-case approach to a blanket exemptionfrom accreditation requirements forprograms below an arbitrary size. Sucha blanket exemption would not beconsistent with the intent of thisregulatory initiative—to enhance thequality of opioid agonist treatment. TheSecretary believes that, taken together,these considerations can mitigate theimpact on small entities, while stillmeeting the objectives of thisrulemaking.

C. Unfunded Mandates Reform Act of1995

The Secretary has examined theimpact of this rule under the UnfundedMandates Reform Act of 1995 (UMRA)(Public Law 104–4). This rule does nottrigger the requirement for a writtenstatement under section 202(a) of theUMRA because it does not impose amandate that results in an expenditureof $100 million (adjusted annually forinflation) or more by State, local, andtribal governments in the aggregate, orby the private sector, in any one year.

IV. Environmental ImpactThe Secretary has previously

considered the environmental effects ofthis rule as announced in the proposedrule (64 FR 39810 at 39825). No newinformation or comments have beenreceived that would affect the agency’sprevious determination that there is nosignificant impact on the humanenvironment and that neither anenvironmental assessment nor anenvironmental impact statement isrequired.

V. Executive Order 13132: FederalismThe Secretary has analyzed this final

rule in accordance with Executive Order

13132: Federalism. Executive Order13132 requires Federal agencies tocarefully examine actions to determineif they contain policies that havefederalism implications or that preemptState law. As defined in the Order,‘‘policies that have federalismimplications’’ refer to regulations,legislative comments or proposedlegislation, and other policy statementsor actions that have substantial directeffects on the States, on the relationshipbetween the national government andthe States, or on the distribution ofpower and responsibilities among thevarious levels of government.

The Secretary is publishing this finalrule to set forth treatment regulationsthat provide for the use of approvedopioid agonist treatment medications inthe treatment of opiate addiction. TheNarcotic Addict Treatment Act (theNATA, Pub. L. 93–281) modified theControlled Substances Act (CSA) toestablish the basis for the Federalcontrol of narcotic addiction treatmentby the Attorney General and theSecretary. Because enforcement of thesesections of the CSA is a Federalresponsibility, there should be little, ifany, impact from this rule on thedistribution of power andresponsibilities among the variouslevels of government. In addition, thisregulation does not preempt State law.Accordingly, the Secretary hasdetermined that this final rule does notcontain policies that have federalismimplications or that preempt State law.

VI. Paperwork Reduction Act of 1995

This final rule contains informationcollection provisions which are subjectto review by the Office of Managementand Budget (OMB) under the PaperworkReduction Act of 1995 (the PRA)(44U.S.C. 3507(d)). The title, descriptionand respondent description of theinformation collections are shown in thefollowing paragraphs with an estimateof the annual reporting burden.Included in the estimate is the time for

reviewing instructions, searchingexisting data sources, gathering andmaintaining the data needed, andcompleting and reviewing the collectionof information.

Title: Narcotic Drugs in Maintenanceand Detoxification Treatment ofNarcotic Dependence; Repeal of CurrentRegulations and Adoption of NewRegulations.

Description: The Secretary is issuingregulations to establish an accreditation-based regulatory system to replace thecurrent system that relies solely upondirect Federal inspection of treatmentprograms for compliance with process-oriented regulations.

These new rules are intended toenhance the quality of opioid treatmentby allowing increased clinical judgmentin treatment and by the accreditationprocess itself with its emphasis oncontinuous quality assessment. As setforth in this final rule, there will befewer reporting requirements and fewerrequired forms under the new system.The total reporting requirements areestimated at 2,071 hours for treatmentprograms, and 341 hours for accreditingorganizations as outlined in Tables 1and 2.

The regulation requires a one-timereporting requirement for transitioningfrom the old system to the new system.The estimated reporting burden for‘‘transitional certification’’ isapproximately 475 hours. The proposalalso requires ongoing certification on a3-year cycle, with an estimatedreporting burden of approximately 300hours.

Description of Respondents: Businessor other for-profit; Not-for-profitinstitutions; Federal Government; State,local or tribal government.

No comments were submitted inresponse to the Secretary’s invitation inthe July 22, 1999, proposal to commenton the information collectionrequirements.

TABLE 1.—ANNUAL REPORTING BURDEN FOR TREATMENT PROGRAMS

42 CFR citation Purpose Number ofrespondents

Responses/respondent

Hours/response Total hours

8.11(b) .............................. New programs approval (SMA–162) ........................ 75 1 1.50 112.508.11(b) .............................. Renewal of approval (SMA–162) 1 ........................... 300 1 1.00 300.008.11(b) .............................. Relocation of program (SMA–162) ........................... 35 1 1.17 40.838.11(d) .............................. Application for transitional certification (SMA–162) 2 300 1 1.58 475.008.11(e)(1) .......................... Application for provisional certification ..................... 75 1 .50 37.508.11(e)(2) .......................... Application for extension of provisional certification 30 1 .25 7.508.11(f)(5) ........................... Notification of sponsor or medical director change .. 60 1 .33 20.008.11(g)(2) .......................... Documentation to SAMHSA for interim mainte-

nance.1 1 2 2.00

8.11(h) .............................. Request to SAMHSA for Exemption from 8.11 and8.12.

800 3 .438 1050.00

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TABLE 1.—ANNUAL REPORTING BURDEN FOR TREATMENT PROGRAMS—Continued

42 CFR citation Purpose Number ofrespondents

Responses/respondent

Hours/response Total hours

8.11(i)(1) ........................... Notification to SAMHSA Before Establishing Medi-cation Units.

3 1 .25 .75

8.12(j)(2) ........................... Notification to State Health Officer When PatientBegins Interim Maintenance.

1 1 .33 .33

8.24 .................................. Contents of Appellant Request for Review of Sus-pension.

2 1 .25 .50

8.25(a) .............................. Informal Review Request .......................................... 2 1 1.00 2.008.26(a) .............................. Appellant’s Review File and Written Statement ....... 2 1 5.00 10.008.28(a) .............................. Appellant’s Request for Expedited Review .............. 2 1 1.00 2.008.28(c) .............................. Appellant’s Review File and Written Statement ....... 2 1 5.00 10.00

Total ....................... ................................................................................... ...................... ...................... ...................... 2,070.91

1 Applications for renewal of certification are required every 3 years.2 Transitional Certification is a one-time requirement and will be included in the total annualized burden but averaged over the 3-year period of

the OMB collection activity approval.

The final rule does not increase theestimated annualized burden. Certainreporting requirements have beeneliminated, such as submissions forauthorizations to use LAAM, therequirement to submit a physicianresponsibility statement (FDA Form2633), and elimination of therequirement to obtain Federal approvalfor take-home doses of methadone inexcess of 100 mg that exceed a 6-daysupply. The new rule adds a one-time

requirement for existing programs toapply for transitional certification, anda requirement to apply for certificationrenewal every third year. Theannualized burdens associated withthese new reporting requirements offsetthe burdens eliminated, resulting in noestimated net change.

Accreditation bodies will also requiretreatment programs to submitinformation as part of the standardoperating procedures for accreditation.

As mentioned earlier in this notice,accreditation bodies, under contract toSAMHSA, have accredited existingOTPs as part of an initiative to gainmore information on the accreditation ofOTPs. SAMHSA prepared a separateOMB Paperwork Reduction notice andanalysis for that information collectionactivity (63 FR 10030, February 27,1998, OMB approval number 0930–0194).

TABLE 2.—ANNUAL REPORTING BURDEN FOR ACCREDITATION ORGANIZATIONS

42 CFR citation Purpose No. ofrespondents

Responses/respondent

Hours/response Total hours

8.3 (b) (1–11) ................... Initial approval (SMA–163) ....................................... 10 1 3.0 30.08.3 (c) ............................... Renewal of approval (SMA-163) .............................. 3 1 1.0 3.08.3 (e) ............................... Relinguishment notification ....................................... 1 1 0.5 0.58.3 (f) (2) .......................... Non-renewal notification to accredited OTP’s .......... 1 90 0.1 9.08.4 (b) (1) (ii) .................... Notification to SAMHSA for serious noncompliant

programs.2 2 1.0 4.0

8.4 (b) (1) (iii) ................... Notification to OTP for serious noncompliance ........ 2 2 1.0 4.08.4 (d) (1) ......................... General document and information to SAMHSA

upon request.10 2 0.5 10.0

8.4 (d) (2) ......................... Accrediation survey to SAMHSA upon request ........ 10 6 0.2 12.08.4 (d) (3) ......................... List of surveys, surveyors to SAMHSA upon re-

quest.10 6 0.2 12.0

8.4 (d) (4) ......................... Less than full accrediation report to SAMHSA ......... 10 7.5 0.5 37.58.4 (d) (5) ......................... Summaries of Inspections ........................................ 10 30 0.5 150.08.4 (e) ............................... Notifications of Compliants ....................................... 10 1 0.5 5.08.6 (a) (2) and (b) (3) ....... Revocation notification to Accredited OTP’s ............ 1 90 0.3 27.08.6 (b) ............................... Submission of 90-day Corrective plan to SAMHSA 1 1 10 10.08.6 (b) (1) ......................... Notification to accredited OTP’s of Probationary

Status.1 90 0.3 27.0

Total ....................... ................................................................................... 82 ...................... ...................... 341

Note: Because some of the numbers underlying these estimates have been rounded, figures in this table are approximate. There are no main-tenance and operation costs nor start up and capital costs.

Recordkeeping—The recordkeepingrequirements for OTPs set forth in sec.8.12 include maintenance of thefollowing: A patient’s medicalevaluation and other assessments whenadmitted to treatment, and periodicallythroughout treatment Sec. 8.12(f)(4));

the provision of needed services,including any prenatal supportprovided the patient (Sec. 8.12(f)(3) and(f)(4)) justification of exceptional initialdoses; changes in a patient’s dose anddosage schedule; justification forvariations from the approved product

labeling for LAAM and futuremedications (Sec. 8.12(h)(4)); and therationale for decreasing a patient’s clinicattendance (Sec. 8.12(i)(3)).

In addition, sec. 8.4(c)(1) will requireaccreditation bodies to keep and retainfor 5 years certain records pertaining totheir respective accreditation activities.

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These recordkeeping requirements forOTPs and accreditation bodies arecustomary and usual practices withinthe medical and rehabilitativecommunities, and thus impose noadditional response burden hours orcosts.

Disclosure—This final rule retainsrequirements that OTPs andaccreditation organizations discloseinformation. For example, sec. 8.12(e)(1)requires that a physician explain thefacts concerning the use of opioid drugtreatment to each patient. This type ofdisclosure is considered to be consistentwith the common medical practice andis not considered an additional burden.Further, the new rules require undersec. 8.4(i)(1) that each accreditationorganization shall make public its feestructure. The Secretary notes that thepreceding section of this notice containspublicly available information on thefee structure for each of threeaccreditation bodies. This type ofdisclosure is standard business practiceand is not considered a burden in thisanalysis.

Individuals and organizations maysubmit comments on these burdenestimates or any other aspect of theseinformation collection provisions,including suggestions for reducing theburden, and should direct them to:SAMHSA Reports Clearance Officer,Room 16–105, Parklawn Building, 5600Fishers Lane, Rockville, MD 20857.

The information collection provisionsin this final rule have been approvedunder OMB control number 0930–0206.This approval expires 09/30/2002. Anagency may not conduct or sponsor, anda person is not required to respond to,a collection of information unless itdisplays a currently valid OMB controlnumber.

Nelba Chavez,Administrator, Substance Abuse and MentalHealth Services, Administration.

Dated: January 5, 2001.Donna E. Shalala,Secretary of Health and Human Services.

VII. ReferencesThe following references have been

placed on display at SAMHSA/CSATReading Room (7–220), 5515 SecurityLane, Rockville, MD 20852.

1. Institute of Medicine, Federal Regulationof Methadone Treatment, National AcademyPress, 1995.

2. ‘‘New Hampshire Legislature AllowsMethadone Treatment,’’ Copyright 2000,Alcoholism & Drug Abuse Weekly, ManissesCommunications Group, Inc., Vol. 12, No. 23,Monday, June 5, 2000.

3. Sees, K.L., D.O., et al., ‘‘MethadoneMaintenance vs 180-Day PsychosociallyEnriched Detoxification for Treatment of

Opioid Dependence, A RandomizedControlled Trial,’’ Journal of the AmericanMedical Association, Vol 283, No. 10 p1303–1310, March 8, 2000.

4. Clark, H. Westly, M.D., Lepay, David,M.D., ‘‘Dear Colleague Letter on MedicalMaintenance’’, March 30, 2000.

5. Schwartz, M.D., et al., ‘‘A 12-YearFollow-Up of a Methadone MedicalMaintenance Program, Am J Addiction, Vol.8, pp 293–299, 1999.

List of Subjects

21 CFR Part 291

Health professions, Methadone,Reporting and recordkeepingrequirements.

42 CFR Part 8

Health professions, Levo-Alpha-Acetyl-Methadol (LAAM), Methadone,Reporting and recordkeepingrequirements.

Therefore, under the ComprehensiveDrug Abuse Prevention and Control Actof 1970, the Controlled Substances Actas amended by the Narcotic AddictTreatment Act of 1974, the PublicHealth Service Act, and applicabledelegations of authority thereunder,titles 21 and 42 of the Code of FederalRegulations are amended as follows:

21 CFR Chapter I

PART 291—[REMOVED]

1. Under authority of sections 301(d),543, 1976 of the Public Health ServiceAct (42 U.S.C. 241(d), 290dd–2, 300y–11); 38 U.S.C. 7332, 42 U.S.C. 257a; andsection 303(g) of the ControlledSubstances Act (21 U.S.C. 823(g)),amend title 21 of the Code of FederalRegulations by removing part 291.

42 CFR Chapter I

2. Amend 42 CFR Chapter I by addingpart 8 to subchapter A to read asfollows:

PART 8—CERTIFICATION OF OPIOIDTREATMENT PROGRAMS

Subpart A—Accreditation

Sec.8.1 Scope.8.2 Definitions.8.3 Application for approval as an

accreditation body.8.4 Accreditation body responsibilities.8.5 Periodic evaluation of accreditation

bodies.8.6 Withdrawal of approval of accreditation

bodies.

Subpart B—Certification and TreatmentStandards

8.11 Opioid treatment programcertification.

8.12 Federal opioid treatment standards.

8.13 Revocation of accreditation andaccreditation body approval.

8.14 Suspension or revocation ofcertification.

8.15 Forms.

Subpart C—Procedures for Review ofSuspension or Proposed Revocation ofOTP Certification, and of Adverse ActionRegarding Withdrawal of Approval of anAccreditation Body

8.21 Applicability.8.22 Definitions.8.23 Limitation on issues subject to review.8.24 Specifying who represents the parties.8.25 Informal review and the reviewing

official’s response.8.26 Preparation of the review file and

written arguments.8.27 Opportunity for oral presentation.8.28 Expedited procedures for review of

immediate suspension.8.29 Ex parte communications.8.30 Transmission of written

communications by reviewing officialand calculation of deadlines.

8.31 Authority and responsibilities of thereviewing official.

8.32 Administrative record.8.33 Written decision.8.34 Court review of final administrative

action; exhaustion of administrativeremedies.

Authority: 21 U.S.C. 823; 42 U.S.C. 257a,290aa(d), 290dd–2, 300x–23, 300x–27(a),300y–11.

Subpart A—Accreditation

§ 8.1 Scope.The regulations in this part establish

the procedures by which the Secretaryof Health and Human Services (theSecretary) will determine whether apractitioner is qualified under section303(g) of the Controlled Substances Act(21 U.S.C. 823(g)) to dispense opioiddrugs in the treatment of opioidaddiction. These regulations alsoestablish the Secretary’s standardsregarding the appropriate quantities ofopioid drugs that may be provided forunsupervised use by individualsundergoing such treatment (21 U.S.C.823(g)(1)). Under these regulations, apractitioner who intends to dispenseopioid drugs in the treatment of opioidaddiction must first obtain from theSecretary or by delegation, from theAdministrator, Substance Abuse andMental Health Services Administration(SAMHSA), a certification that thepractitioner is qualified under theSecretary’s standards and will complywith such standards. Eligibility forcertification will depend upon thepractitioner obtaining accreditationfrom an accreditation body that hasbeen approved by SAMHSA. Theseregulations establish the procedureswhereby an entity can apply to becomean approved accreditation body. This

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part also establishes requirements andgeneral standards for accreditationbodies to ensure that practitioners areconsistently evaluated for compliancewith the Secretary’s standards for opiateaddiction treatment with an opioidagonist treatment medication.

§ 8.2 Definitions.The following definitions apply to

this part:Accreditation means the process of

review and acceptance by anaccreditation body.

Accreditation body means a body thathas been approved by SAMHSA under§ 8.3 to accredit opioid treatmentprograms using opioid agonist treatmentmedications.

Accreditation body application meansthe application filed with SAMHSA forpurposes of obtaining approval as anaccreditation body, as described in§ 8.3(b).

Accreditation elements mean theelements or standards that aredeveloped and adopted by anaccreditation body and approved bySAMHSA.

Accreditation survey means an onsitereview and evaluation of an opioidtreatment program by an accreditationbody for the purpose of determiningcompliance with the Federal opioidtreatment standards described in § 8.12.

Accredited opioid treatment programmeans an opioid treatment program thatis the subject of a current, validaccreditation from an accreditation bodyapproved by SAMHSA under § 8.3(d).

Certification means the process bywhich SAMHSA determines that anopioid treatment program is qualified toprovide opioid treatment under theFederal opioid treatment standards.

Certification application means theapplication filed by an opioid treatmentprogram for purposes of obtainingcertification from SAMHSA, asdescribed in § 8.11(b).

Certified opioid treatment programmeans an opioid treatment program thatis the subject of a current, validcertification under § 8.11.

Comprehensive maintenancetreatment is maintenance treatmentprovided in conjunction with acomprehensive range of appropriatemedical and rehabilitative services.

Detoxification treatment means thedispensing of an opioid agonisttreatment medication in decreasingdoses to an individual to alleviateadverse physical or psychologicaleffects incident to withdrawal from thecontinuous or sustained use of anopioid drug and as a method of bringingthe individual to a drug-free state withinsuch period.

Federal opioid treatment standardsmeans the standards established by theSecretary in § 8.12 that are used todetermine whether an opioid treatmentprogram is qualified to engage in opioidtreatment. The Federal opioid treatmentstandards established in § 8.12 alsoinclude the standards established by theSecretary regarding the quantities ofopioid drugs which may be provided forunsupervised use.

For-cause inspection means aninspection of an opioid treatmentprogram by the Secretary, or by anaccreditation body, that may beoperating in violation of Federal opioidtreatment standards, may be providingsubstandard treatment, or may beserving as a possible source of divertedmedications.

Interim maintenance treatment meansmaintenance treatment provided inconjunction with appropriate medicalservices while a patient is awaitingtransfer to a program that providescomprehensive maintenance treatment.

Long-term detoxification treatmentmeans detoxification treatment for aperiod more than 30 days but not inexcess of 180 days.

Maintenance treatment means thedispensing of an opioid agonisttreatment medication at stable dosagelevels for a period in excess of 21 daysin the treatment of an individual foropioid addiction.

Medical director means a physician,licensed to practice medicine in thejurisdiction in which the opioidtreatment program is located, whoassumes responsibility for administeringall medical services performed by theprogram, either by performing themdirectly or by delegating specificresponsibility to authorized programphysicians and healthcare professionalsfunctioning under the medical director’sdirect supervision.

Medical and rehabilitative servicesmeans services such as medicalevaluations, counseling, andrehabilitative and other social programs(e.g., vocational and educationalguidance, employment placement), thatare intended to help patients in opioidtreatment programs become and/orremain productive members of society.

Medication unit means a facilityestablished as part of, butgeographically separate from, an opioidtreatment program from which licensedprivate practitioners or communitypharmacists dispense or administer anopioid agonist treatment medication orcollect samples for drug testing oranalysis.

Opiate addiction is defined as acluster of cognitive, behavioral, andphysiological symptoms in which the

individual continues use of opiatesdespite significant opiate-inducedproblems. Opiate dependence ischaracterized by repeated self-administration that usually results inopiate tolerance, withdrawal symptoms,and compulsive drug-taking.Dependence may occur with or withoutthe physiological symptoms of toleranceand withdrawal.

Opioid agonist treatment medicationmeans any opioid agonist drug that isapproved by the Food and DrugAdministration under section 505 of theFederal Food, Drug, and Cosmetic Act(21 U.S.C. 355) for use in the treatmentof opiate addiction.

Opioid drug means any drug havingan addiction-forming or addiction-sustaining liability similar to morphineor being capable of conversion into adrug having such addiction-forming oraddiction-sustaining liability.

Opioid treatment means thedispensing of an opioid agonisttreatment medication, along with acomprehensive range of medical andrehabilitative services, when clinicallynecessary, to an individual to alleviatethe adverse medical, psychological, orphysical effects incident to opiateaddiction. This term encompassesdetoxification treatment, short-termdetoxification treatment, long-termdetoxification treatment, maintenancetreatment, comprehensive maintenancetreatment, and interim maintenancetreatment.

Opioid treatment program or ‘‘OTP’’means a program or practitionerengaged in opioid treatment ofindividuals with an opioid agonisttreatment medication.

Patient means any individual whoundergoes treatment in an opioidtreatment program.

Program sponsor means the personnamed in the application forcertification described in § 8.11(b) asresponsible for the operation of theopioid treatment program and whoassumes responsibility for all itsemployees, including any practitioners,agents, or other persons providingmedical, rehabilitative, or counselingservices at the program or any of itsmedication units. The program sponsorneed not be a licensed physician butshall employ a licensed physician forthe position of medical director.

Registered opioid treatment programmeans an opioid treatment program thatis registered under 21 U.S.C. 823(g).

Short-term detoxification treatmentmeans detoxification treatment for aperiod not in excess of 30 days.

State Authority is the agencydesignated by the Governor or otherappropriate official designated by the

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Governor to exercise the responsibilityand authority within the State orTerritory for governing the treatment ofopiate addiction with an opioid drug.

Treatment plan means a plan thatoutlines for each patient attainableshort-term treatment goals that aremutually acceptable to the patient andthe opioid treatment program and whichspecifies the services to be provided andthe frequency and schedule for theirprovision.

§ 8.3 Application for approval as anaccreditation body.

(a) Eligibility. Private nonprofitorganizations or State governmentalentities, or political subdivisionsthereof, capable of meeting therequirements of this part may apply forapproval as an accreditation body.

(b) Application for initial approval.Three copies of an accreditation bodyapplication form [SMA–163] shall besubmitted to SAMHSA at rm. 12–105,5600 Fishers Lane, Rockville, MD20857, and marked ATTENTION: OTPCertification Program. SAMHSA willconsider and accept the electronicsubmission of these materials whenelectronic submission systems aredeveloped and available. Accreditationbody applications shall include thefollowing information and supportingdocumentation:

(1) Name, address, and telephonenumber of the applicant and aresponsible official for the accreditationbody. The application shall be signed bythe responsible official;

(2) Evidence of the nonprofit status ofthe applicant (i.e., of fulfilling InternalRevenue Service requirements as anonprofit organization) if the applicantis not a State governmental entity orpolitical subdivision;

(3) A set of the accreditation elementsor standards and a detailed discussionshowing how the proposedaccreditation elements or standards willensure that each OTP surveyed by theapplicant is qualified to meet or ismeeting each of the Federal opioidtreatment standards set forth in § 8.12;

(4) A detailed description of theapplicant’s decisionmaking process,including:

(i) Procedures for initiating andperforming onsite accreditation surveysof OTPs;

(ii) Procedures for assessing OTPpersonnel qualifications;

(iii) Copies of an application foraccreditation, guidelines, instructions,and other materials the applicant willsend to OTPs during the accreditationprocess, including a request for acomplete history of prior accreditationactivities and a statement that all

information and data submitted in theapplication for accreditation is true andaccurate, and that no material fact hasbeen omitted;

(iv) Policies and procedures fornotifying OTPs and SAMHSA ofdeficiencies and for monitoringcorrections of deficiencies by OTPs;

(v) Policies and procedures forsuspending or revoking an OTP’saccreditation;

(vi) Policies and procedures that willensure processing of applications foraccreditation and applications forrenewal of accreditation within atimeframe approved by SAMHSA; and

(vii) A description of the applicant’sappeals process to allow OTPs tocontest adverse accreditation decisions.

(5) Policies and proceduresestablished by the accreditation body toavoid conflicts of interest, or theappearance of conflicts of interest, bythe applicant’s board members,commissioners, professional personnel,consultants, administrative personnel,and other representatives;

(6) A description of the education,experience, and training requirementsfor the applicant’s professional staff,accreditation survey team membership,and the identification of at least onelicensed physician on the applicant’sstaff;

(7) A description of the applicant’straining policies;

(8) Fee schedules, with supportingcost data;

(9) Satisfactory assurances that thebody will comply with the requirementsof § 8.4, including a contingency planfor investigating complaints under§ 8.4(e);

(10) Policies and proceduresestablished to protect confidentialinformation the applicant will collect orreceive in its role as an accreditationbody; and

(11) Any other information SAMHSAmay require.

(c) Application for renewal ofapproval. An accreditation body thatintends to continue to serve as anaccreditation body beyond its currentterm shall apply to SAMHSA forrenewal, or notify SAMHSA of itsintention not to apply for renewal, inaccordance with the followingprocedures and schedule:

(1) At least 9 months before the dateof expiration of an accreditation body’sterm of approval, the body shall informSAMHSA in writing of its intent to seekrenewal.

(2) SAMHSA will notify the applicantof the relevant information, materials,and supporting documentation requiredunder paragraph (b) of this section that

the applicant shall submit as part of therenewal procedure.

(3) At least 3 months before the dateof expiration of the accreditation body’sterm of approval, the applicant shallfurnish to SAMHSA three copies of arenewal application containing theinformation, materials, and supportingdocumentation requested by SAMHSAunder paragraph (c)(2) of this section.

(4) An accreditation body that doesnot intend to renew its approval shall sonotify SAMHSA at least 9 months beforethe expiration of the body’s term ofapproval.

(d) Rulings on applications for initialapproval or renewal of approval. (1)SAMHSA will grant an application forinitial approval or an application forrenewal of approval if it determines theapplicant substantially meets theaccreditation body requirements of thissubpart.

(2) If SAMHSA determines that theapplicant does not substantially meetthe requirements set forth in thissubpart. SAMHSA will notify theapplicant of the deficiencies in theapplication and request that theapplicant resolve such deficiencieswithin 90 days of receipt of the notice.If the deficiencies are resolved to thesatisfaction of SAMHSA within the 90-day time period, the body will beapproved as an accreditation body. Ifthe deficiencies have not been resolvedto the satisfaction of SAMHSA withinthe 90-day time period, the applicationfor approval as an accreditation bodywill be denied.

(3) If SAMHSA does not reach a finaldecision on a renewal application beforethe expiration of an accreditation body’sterm of approval, the approval will bedeemed extended until SAMHSAreaches a final decision, unless anaccreditation body does not rectifydeficiencies in the application withinthe specified time period, as required inparagraph (d)(2) of this section.

(e) Relinquishment of approval. Anaccreditation body that intends torelinquish its accreditation approvalbefore expiration of the body’s term ofapproval shall submit a letter of suchintent to SAMHSA, at the address inparagraph (b) of this section, at least 9months before relinquishing suchapproval.

(f) Notification. An accreditation bodythat does not apply for renewal ofapproval, or is denied such approval bySAMHSA, relinquishes its accreditationapproval before expiration of its term ofapproval, or has its approvalwithdrawn, shall:

(1) Transfer copies of records andother related information as required bySAMHSA to a location, including

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another accreditation body, andaccording to a schedule approved bySAMHSA; and

(2) Notify, in a manner and timeperiod approved by SAMHSA, all OTPsaccredited or seeking accreditation bythe body that the body will no longerhave approval to provide accreditationservices.

(g) Term of approval. An accreditationbody’s term of approval is for a periodnot to exceed 5 years.

(h) State accreditation bodies. Stategovernmental entities, includingpolitical subdivisions thereof, mayestablish organizational units that mayact as accreditation bodies, providedsuch units meet the requirements of thissection, are approved by SAMHSAunder this section, and have takenappropriate measures to prevent actualor apparent conflicts of interest,including cases in which State orFederal funds are used to supportopioid treatment services.

§ 8.4 Accreditation body responsibilities.(a) Accreditation surveys and for

cause inspections. (1) Accreditationbodies shall conduct routineaccreditation surveys for initial,renewal, and continued accreditation ofeach OTP at least every 3 years.

(2) Accreditation bodies must agree toconduct for-cause inspections upon therequest of SAMHSA.

(3) Accreditation decisions shall befully consistent with the policies andprocedures submitted as part of theapproved accreditation bodyapplication.

(b) Response to noncompliantprograms. (1) If an accreditation bodyreceives or discovers information thatsuggests that an OTP is not meetingFederal opioid treatment standards, or ifsurvey of the OTP by the accreditationbody otherwise demonstrates one ormore deficiencies in the OTP, theaccreditation body shall as appropriateeither require and monitor correctiveaction or shall suspend or revokeaccreditation of the OTP, as appropriatebased on the significance of thedeficiencies.

(i) Accreditation bodies shall eithernot accredit or shall revoke theaccreditation of any OTP thatsubstantially fails to meet the Federalopioid treatment standards.

(ii) Accreditation bodies shall notifySAMHSA as soon as possible but in nocase longer than 48 hours afterbecoming aware of any practice orcondition in an OTP that may pose aserious risk to public health or safety orpatient care.

(iii) If an accreditation bodydetermines that an OTP is substantially

meeting the Federal opioid treatmentstandards, but is not meeting one ormore accreditation elements, theaccreditation body shall determine thenecessary corrective measures to betaken by the OTP, establish a schedulefor implementation of such measures,and notify the OTP in writing that itmust implement such measures withinthe specified schedule in order toensure continued accreditation. Theaccreditation body shall verify that thenecessary steps are taken by the OTPwithin the schedule specified and thatall accreditation elements are beingsubstantially met or will besubstantially met.

(2) Nothing in this part shall preventaccreditation bodies from grantingaccreditation, contingent on promisedprogrammatic or performance changes,to OTPs with less substantial violations.Such accreditation shall not exceed 12months. OTPs that have been grantedsuch accreditation must have theiraccreditation revoked if they fail tomake changes to receive unconditionalaccreditation upon resurvey orreinspection.

(c) Recordkeeping. (1) Accreditationbodies shall maintain records of theiraccreditation activities for at least 5years from the creation of the record.Such records must contain sufficientdetail to support each accreditationdecision made by the accreditationbody.

(2) Accreditation bodies shallestablish procedures to protectconfidential information collected orreceived in their role as accreditationbodies that are consistent with, and thatare designed to ensure compliance with,all Federal and State laws, including 42CFR part 2.

(i) Information collected or receivedfor the purpose of carrying outaccreditation body responsibilities shallnot be used for any other purpose ordisclosed, other than to SAMHSA or itsduly designated representatives, unlessotherwise required by law or with theconsent of the OTP.

(ii) Nonpublic information thatSAMHSA shares with the accreditationbody concerning an OTP shall not befurther disclosed except with thewritten permission of SAMHSA.

(d) Reporting. (1) Accreditation bodiesshall provide to SAMHSA anydocuments and information requestedby SAMHSA within 5 days of receipt ofthe request.

(2) Accreditation bodies shall make asummary of the results of eachaccreditation survey available toSAMHSA upon request. Suchsummaries shall contain sufficient

detail to justify the accreditation actiontaken.

(3) Accreditation bodies shall provideSAMHSA upon request a list of eachOTP surveyed and the identity of allindividuals involved in the conduct andreporting of survey results.

(4) Accreditation bodies shall submitto SAMHSA the name of each OTP forwhich the accreditation body accreditsconditionally, denies, suspends, orrevokes accreditation, and the basis forthe action, within 48 hours of theaction.

(5) Notwithstanding any reports madeto SAMHSA under paragraphs (d)(1)through (d)(4) of this section, eachaccreditation body shall submit toSAMHSA semiannually, on January 15and July 15 of each calendar year, areport consisting of a summary of theresults of each accreditation surveyconducted in the past year. Thesummary shall contain sufficient detailto justify each accreditation actiontaken.

(6) All reporting requirements listedin this section shall be provided toSAMHSA at the address specified in§ 8.3(b).

(e) Complaint response. Accreditationbodies shall have policies andprocedures to respond to complaintsfrom SAMHSA, patients, facility staff,and others, within a reasonable periodof time but not more than 5 days of thereceipt of the complaint. Accreditationbodies shall also agree to notifySAMHSA within 48 hours of receipt ofa complaint and keep SAMHSAinformed of all aspects of the responseto the complaint.

(f) Modifications of accreditationelements. Accreditation bodies shallobtain SAMHSA’s authorization prior tomaking any substantive (i.e.,noneditorial) change in accreditationelements.

(g) Conflicts of interest. Theaccreditation body shall maintain andapply policies and procedures thatSAMHSA has approved in accordancewith § 8.3 to reduce the possibility ofactual conflict of interest, or theappearance of a conflict of interest, onthe part of individuals who act onbehalf of the accreditation body.Individuals who participate inaccreditation surveys or otherwiseparticipate in the accreditation decisionor an appeal of the accreditationdecision, as well as their spouses andminor children, shall not have afinancial interest in the OTP that is thesubject of the accreditation survey ordecision.

(h) Accreditation teams. (1) Anaccreditation body survey team shallconsist of healthcare professionals with

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expertise in drug abuse treatment and,in particular, opioid treatment. Theaccreditation body shall consider factorssuch as the size of the OTP, theanticipated number of problems, andthe OTP’s accreditation history, indetermining the composition of theteam. At a minimum, survey teams shallconsist of at least two healthcareprofessionals whose combined expertiseincludes:

(i) The dispensing and administrationof drugs subject to control under theControlled Substances Act (21 U.S.C.801 et seq.);

(ii) Medical issues relating to thedosing and administration of opioidagonist treatment medications for thetreatment of opioid addiction;

(iii) Psychosocial counseling ofindividuals undergoing opioidtreatment; and

(iv) Organizational and administrativeissues associated with opioid treatmentprograms.

(2) Members of the accreditation teammust be able to recuse themselves at anytime from any survey in which eitherthey or the OTP believes there is anactual conflict of interest or theappearance of a conflict of interest.

(i) Accreditation fees. Fees charged toOTPs for accreditation shall bereasonable. SAMHSA generally willfind fees to be reasonable if the fees arelimited to recovering costs to theaccreditation body, including overheadincurred. Accreditation body activitiesthat are not related to accreditationfunctions are not recoverable throughfees established for accreditation.

(1) The accreditation body shall makepublic its fee structure, including thosefactors, if any, contributing to variationsin fees for different OTPs.

(2) At SAMHSA’s request,accreditation bodies shall provide toSAMHSA financial records or othermaterials, in a manner specified bySAMHSA, to assist in assessing thereasonableness of accreditation bodyfees.

§ 8.5 Periodic evaluation of accreditationbodies.

SAMHSA will evaluate periodicallythe performance of accreditation bodiesprimarily by inspecting a selectedsample of the OTPs accredited by theaccrediting body and by evaluating theaccreditation body’s reports of surveysconducted, to determine whether theOTPs surveyed and accredited by theaccreditation body are in compliancewith the Federal opioid treatmentstandards. The evaluation will include adetermination of whether there aremajor deficiencies in the accreditationbody’s performance that, if not

corrected, would warrant withdrawal ofthe approval of the accreditation bodyunder § 8.6.

§ 8.6 Withdrawal of approval ofaccreditation bodies.

If SAMHSA determines that anaccreditation body is not in substantialcompliance with this subpart, SAMHSAshall take appropriate action as follows:

(a) Major deficiencies. If SAMHSAdetermines that the accreditation bodyhas a major deficiency, such ascommission of fraud, material falsestatement, failure to perform a majoraccreditation function satisfactorily, orsignificant noncompliance with therequirements of this subpart, SAMHSAshall withdraw approval of thataccreditation body.

(1) In the event of a major deficiency,SAMHSA shall notify the accreditationbody of the agency’s action and thegrounds on which the approval waswithdrawn.

(2) An accreditation body that has lostits approval shall notify each OTP thathas been accredited or is seekingaccreditation that the accreditationbody’s approval has been withdrawn.Such notification shall be made withina time period and in a manner approvedby SAMHSA.

(b) Minor deficiencies. If SAMHSAdetermines that the accreditation bodyhas minor deficiencies in theperformance of an accreditationfunction, that are less serious or morelimited than the types of deficienciesdescribed in paragraph (a) of thissection, SAMHSA will notify the bodythat it has 90 days to submit toSAMHSA a plan of corrective action.The plan must include a summary ofcorrective actions and a schedule fortheir implementation. SAMHSA mayplace the body on probationary statusfor a period of time determined bySAMHSA, or may withdraw approval ofthe body if corrective action is nottaken.

(1) If SAMHSA places anaccreditation body on probationarystatus, the body shall notify all OTPsthat have been accredited, or that areseeking accreditation, of theaccreditation body’s probationary statuswithin a time period and in a mannerapproved by SAMHSA.

(2) Probationary status will remain ineffect until such time as the body candemonstrate to the satisfaction ofSAMHSA that it has successfullyimplemented or is implementing thecorrective action plan within theestablished schedule, and the correctiveactions taken have substantiallyeliminated all identified problems.

(3) If SAMHSA determines that anaccreditation body that has been placedon probationary status is notimplementing corrective actionssatisfactorily or within the establishedschedule, SAMHSA may withdrawapproval of the accreditation body. Theaccreditation body shall notify all OTPsthat have been accredited, or are seekingaccreditation, of the accreditationbody’s loss of SAMHSA approval withina time period and in a manner approvedby SAMHSA.

(c) Reapplication. (1) An accreditationbody that has had its approvalwithdrawn may submit a newapplication for approval if the body canprovide information to SAMHSA toestablish that the problems that weregrounds for withdrawal of approvalhave been resolved.

(2) If SAMHSA determines that thenew application demonstrates that thebody satisfactorily has addressed thecauses of its previous unacceptableperformance, SAMHSA may reinstateapproval of the accreditation body.

(3) SAMHSA may request additionalinformation or establish additionalconditions that must be met beforeSAMHSA approves the reapplication.

(4) SAMHSA may refuse to accept anapplication from a former accreditationbody whose approval was withdrawnbecause of fraud, material falsestatement, or willful disregard of publichealth.

(d) Hearings. An opportunity tochallenge an adverse action takenregarding withdrawal of approval of anaccreditation body shall be addressedthrough the relevant procedures setforth in subpart C of this part, exceptthat the procedures in § 8.28 forexpedited review of an immediatesuspension would not apply to anaccreditation body that has beennotified under paragraph (a) or (b) ofthis section of the withdrawal of itsapproval.

Subpart B—Certification andTreatment Standards

§ 8.11 Opioid treatment programcertification.

(a) General. (1) An OTP must be thesubject of a current, valid certificationfrom SAMHSA to be consideredqualified by the Secretary under section303(g)(1) of the Controlled SubstancesAct (21 U.S.C. 823(g)(1)) to dispenseopioid drugs in the treatment of opioidaddiction. An OTP must be determinedto be qualified under section 303(g)(1) ofthe Controlled Substances Act, andmust be determined to be qualified bythe Attorney General under section303(g)(1), to be registered by the

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Attorney General to dispense opioidagonist treatment medications toindividuals for treatment of opioidaddiction.

(2) To obtain certification fromSAMHSA, an OTP must meet theFederal opioid treatment standards in§ 8.12, must be the subject of a current,valid accreditation by an accreditationbody or other entity designated bySAMHSA, and must comply with anyother conditions for certificationestablished by SAMHSA.

(3) Certification shall be granted for aterm not to exceed 3 years, except thatcertification may be extended during thethird year if an application foraccreditation is pending.

(b) Application for certification. Threecopies of an application for certificationmust be submitted by the OTP to theaddress identified in § 8.3(b). SAMHSAwill consider and accept the electronicsubmission of these materials whenelectronic submission systems aredeveloped and available. Theapplication for certification shallinclude:

(1) A description of the currentaccreditation status of the OTP;

(2) A description of the organizationalstructure of the OTP;

(3) The names of the personsresponsible for the OTP;

(4) The addresses of the OTP and ofeach medication unit or other facilityunder the control of the OTP;

(5) The sources of funding for the OTPand the name and address of eachgovernmental entity that provides suchfunding; and

(6) A statement that the OTP willcomply with the conditions ofcertification set forth in paragraph (f) ofthis section.

(7) The application shall be signed bythe program sponsor who shall certifythat the information submitted in theapplication is truthful and accurate.

(c) Action on application. (1)Following SAMHSA’s receipt of anapplication for certification of an OTP,and after consultation with theappropriate State authority regardingthe qualifications of the applicant,SAMHSA may grant the application forcertification, or renew an existingcertification, if SAMHSA determinesthat the OTP has satisfied therequirements for certification or renewalof certification.

(2) SAMHSA may deny theapplication if SAMHSA determines that:

(i) The application for certification isdeficient in any respect;

(ii) The OTP will not be operated inaccordance with the Federal opioidtreatment standards established under§ 8.12;

(iii) The OTP will not permit aninspection or a survey to proceed, orwill not permit in a timely manneraccess to relevant records orinformation; or

(iv) The OTP has mademisrepresentations in obtainingaccreditation or in applying forcertification.

(3) Within 5 days after it reaches afinal determination that an OTP meetsthe requirements for certification,SAMHSA will notify the DrugEnforcement Administration (DEA) thatthe OTP has been determined to bequalified to provide opioid treatmentunder section 303(g)(1) of the ControlledSubstances Act.

(d) Transitional certification. OTPsthat before March 19, 2001 were thesubject of a current, valid approval byFDA under 21 CFR, part 291 (containedin the 21 CFR Parts 200 to 299 edition,revised as of July 1, 2000), are deemedto be the subject of a current validcertification for purposes of paragraph(a)(11) of this section. Such ‘transitionalcertification’ will expire on June 18,2001 unless the OTP submits theinformation required by paragraph (b) ofthis section to SAMHSA on or beforeJune 18, 2001. In addition to thisapplication, OTPs must certify with awritten statement signed by the programsponsor, that they will apply foraccreditation within 90 days of the dateSAMHSA approves the secondaccreditation body. Transitionalcertification, in that case, will expire onMarch 19, 2003. SAMHSA may extendthe transitional certification of an OTPfor up to one additional year providedthe OTP demonstrates that it hasapplied for accreditation, that anaccreditation survey has taken place oris scheduled to take place, and that anaccreditation decision is expectedwithin a reasonable period of time (e.g.,within 90 days from the date of survey).Transitional certification under thissection may be suspended or revoked inaccordance with § 8.14.

(e) Provisional certification. (1) OTPsthat have no current certification fromSAMHSA, but have applied foraccreditation with an accreditationbody, are eligible to receive aprovisional certification for up to 1 year.To receive a provisional certification, anOTP shall submit the informationrequired by paragraph (b) of this sectionto SAMHSA along with a statementidentifying the accreditation body towhich the OTP has applied foraccreditation, the date on which theOTP applied for accreditation, the datesof any accreditation surveys that havetaken place or are expected to takeplace, and the expected schedule for

completing the accreditation process. Aprovisional certification for up to 1 yearwill be granted, following receipt of theinformation described in this paragraph,unless SAMHSA determines that patienthealth would be adversely affected bythe granting of provisional certification.

(2) An extension of provisionalcertification may be granted inextraordinary circumstances orotherwise to protect public health. Toapply for a 90-day extension ofprovisional certification, an OTP shallsubmit to SAMHSA a statementexplaining its efforts to obtainaccreditation and a schedule forobtaining accreditation as expeditiouslyas possible.

(f) Conditions for certification. (1)OTPs shall comply with all pertinentState laws and regulations. Nothing inthis part is intended to limit theauthority of State and, as appropriate,local governmental entities to regulatethe use of opioid drugs in the treatmentof opioid addiction. The provisions ofthis section requiring compliance withrequirements imposed by State law, orthe submission of applications orreports required by the State authority,do not apply to OTPs operated directlyby the Department of Veterans Affairs,the Indian Health Service, or any otherdepartment or agency of the UnitedStates. Federal agencies operating OTPshave agreed to cooperate voluntarilywith State agencies by grantingpermission on an informal basis fordesignated State representatives to visitFederal OTPs and by furnishing a copyof Federal reports to the State authority,including the reports required underthis section.

(2) OTPs shall allow, in accordancewith Federal controlled substances lawsand Federal confidentiality laws,inspections and surveys by dulyauthorized employees of SAMHSA, byaccreditation bodies, by the DEA, andby authorized employees of any relevantState or Federal governmental authority.

(3) Disclosure of patient recordsmaintained by an OTP is governed bythe provisions of 42 CFR part 2, andevery program must comply with thatpart. Records on the receipt, storage,and distribution of opioid agonisttreatment medications are also subjectto inspection under Federal controlledsubstances laws and under the FederalFood, Drug, and Cosmetic Act (21 U.S.C.321 et seq.). Federally-sponsoredtreatment programs are subject toapplicable Federal confidentialitystatutes.

(4) A treatment program ormedication unit or any part thereof,including any facility or any individual,shall permit a duly authorized employee

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of SAMHSA to have access to and tocopy all records on the use of opioiddrugs in accordance with the provisionsof 42 CFR part 2.

(5) OTPs shall notify SAMHSA within3 weeks of any replacement or otherchange in the status of the programsponsor or medical director.

(6) OTPs shall comply with allregulations enforced by the DEA under21 CFR chapter II, and must beregistered by the DEA beforeadministering or dispensing opioidagonist treatment medications.

(7) OTPs must operate in accordancewith Federal opioid treatment standardsand approved accreditation elements.

(g) Conditions for interimmaintenance treatment programapproval. (1) Before a public ornonprofit private OTP may provideinterim maintenance treatment, theprogram must receive the approval ofboth SAMHSA and the chief publichealth officer of the State in which theOTP operates.

(2) Before SAMHSA may grant suchapproval, the OTP must provideSAMHSA with documentation from thechief public health officer of the State inwhich the OTP operates demonstratingthat:

(i) Such officer does not object to theproviding of interim maintenancetreatment in the State;

(ii) The OTP seeking to provide suchtreatment is unable to place patients ina public or nonprofit privatecomprehensive treatment programwithin a reasonable geographic areawithin 14 days of the time patients seekadmission to such programs;

(iii) The authorization of the OTP toprovide interim maintenance treatmentwill not otherwise reduce the capacityof comprehensive maintenancetreatment programs in the State to admitindividuals (relative to the date onwhich such officer so certifies); and

(iv) The State certifies that eachindividual enrolled in interimmaintenance treatment will betransferred to a comprehensivemaintenance treatment program no laterthan 120 days from the date on whicheach individual first requestedtreatment, as provided in section 1923of the Public Health Service Act (21U.S.C. 300x-23).

(3) SAMHSA will provide notice tothe OTP denying or approving therequest to provide interim maintenancetreatment. The OTP shall not providesuch treatment until it has receivedsuch notice from SAMHSA.

(h) Exemptions. An OTP may, at thetime of application for certification orany time thereafter, request fromSAMHSA exemption from the

regulatory requirements set forth underthis section and § 8.12. An example ofa case in which an exemption might begranted would be for a privatepractitioner who wishes to treat alimited number of patients in a non-metropolitan area with few physiciansand no rehabilitative servicesgeographically accessible and requestsexemption from some of the staffing andservice standards. The OTP shallsupport the rationale for the exemptionwith thorough documentation, to besupplied in an appendix to the initialapplication for certification or in aseparate submission. SAMHSA willapprove or deny such exemptions at thetime of application, or any timethereafter, if appropriate. SAMHSAshall consult with the appropriate Stateauthority prior to taking action on anexemption request.

(i) Medication units, long-term carefacilities and hospitals. (1) CertifiedOTPs may establish medication unitsthat are authorized to dispense opioidagonist treatment medications forobserved ingestion. Before establishing amedication unit, a certified OTP mustnotify SAMHSA by submitting formSMA–162. The OTP must also complywith the provisions of 21 CFR part 1300before establishing a medication unit.Medication units shall comply with allpertinent state laws and regulations.

(2) Certification as an OTP under thispart will not be required for themaintenance or detoxification treatmentof a patient who is admitted to ahospital or long-term care facility for thetreatment of medical conditions otherthan opiate addiction and who requiresmaintenance or detoxification treatmentduring the period of his or her stay inthat hospital or long-term care facility.The terms ‘‘hospital’’ and ‘‘long-termcare facility’’ as used in this section areto have the meaning that is assignedunder the law of the State in which thetreatment is being provided. Nothing inthis section is intended to relievehospitals and long-term care facilitiesfrom the obligation to obtain registrationfrom the Attorney General, asappropriate, under section 303(g) of theControlled Substances Act.

§ 8.12 Federal opioid treatment standards.(a) General. OTPs must provide

treatment in accordance with thestandards in this section and mustcomply with these standards as acondition of certification.

(b) Administrative and organizationalstructure. An OTP’s organizationalstructure and facilities shall be adequateto ensure quality patient care and tomeet the requirements of all pertinentFederal, State, and local laws and

regulations. At a minimum, each OTPshall formally designate a programsponsor and medical director. Theprogram sponsor shall agree on behalf ofthe OTP to adhere to all requirementsset forth in this part and any regulationsregarding the use of opioid agonisttreatment medications in the treatmentof opioid addiction which may bepromulgated in the future. The medicaldirector shall assume responsibility foradministering all medical servicesperformed by the OTP. In addition, themedical director shall be responsible forensuring that the OTP is in compliancewith all applicable Federal, State, andlocal laws and regulations.

(c) Continuous quality improvement.(1) An OTP must maintain currentquality assurance and quality controlplans that include, among other things,annual reviews of program policies andprocedures and ongoing assessment ofpatient outcomes.

(2) An OTP must maintain a current‘‘Diversion Control Plan’’ or ‘‘DCP’’ aspart of its quality assurance programthat contains specific measures toreduce the possibility of diversion ofcontrolled substances from legitimatetreatment use and that assigns specificresponsibility to the medical andadministrative staff of the OTP forcarrying out the diversion controlmeasures and functions described in theDCP.

(d) Staff credentials. Each personengaged in the treatment of opioidaddiction must have sufficienteducation, training, and experience, orany combination thereof, to enable thatperson to perform the assignedfunctions. All physicians, nurses, andother licensed professional careproviders, including addictioncounselors, must comply with thecredentialing requirements of theirrespective professions.

(e) Patient admission criteria.—(1)Maintenance treatment. An OTP shallmaintain current procedures designed toensure that patients are admitted tomaintenance treatment by qualifiedpersonnel who have determined, usingaccepted medical criteria such as thoselisted in the Diagnostic and StatisticalManual for Mental Disorders (DSM-IV),that the person is currently addicted toan opioid drug, and that the personbecame addicted at least 1 year beforeadmission for treatment. In addition, aprogram physician shall ensure thateach patient voluntarily choosesmaintenance treatment and that allrelevant facts concerning the use of theopioid drug are clearly and adequatelyexplained to the patient, and that eachpatient provides informed writtenconsent to treatment.

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(2) Maintenance treatment for personsunder age 18. A person under 18 yearsof age is required to have had twodocumented unsuccessful attempts atshort-term detoxification or drug-freetreatment within a 12-month period tobe eligible for maintenance treatment.No person under 18 years of age may beadmitted to maintenance treatmentunless a parent, legal guardian, orresponsible adult designated by therelevant State authority consents inwriting to such treatment.

(3) Maintenance treatment admissionexceptions. If clinically appropriate, theprogram physician may waive therequirement of a 1-year history ofaddiction under paragraph (e)(1) of thissection, for patients released from penalinstitutions (within 6 months afterrelease), for pregnant patients (programphysician must certify pregnancy), andfor previously treated patients (up to 2years after discharge).

(4) Detoxification treatment. An OTPshall maintain current procedures thatare designed to ensure that patients areadmitted to short- or long-termdetoxification treatment by qualifiedpersonnel, such as a program physician,who determines that such treatment isappropriate for the specific patient byapplying established diagnostic criteria.Patients with two or more unsuccessfuldetoxification episodes within a 12-month period must be assessed by theOTP physician for other forms oftreatment. A program shall not admit apatient for more than two detoxificationtreatment episodes in one year.

(f) Required services.—(1) General.OTPs shall provide adequate medical,counseling, vocational, educational, andother assessment and treatment services.These services must be available at theprimary facility, except where theprogram sponsor has entered into aformal, documented agreement with aprivate or public agency, organization,practitioner, or institution to providethese services to patients enrolled in theOTP. The program sponsor, in anyevent, must be able to document thatthese services are fully and reasonablyavailable to patients.

(2) Initial medical examinationservices. OTPs shall require each patientto undergo a complete, fullydocumented physical evaluation by aprogram physician or a primary carephysician, or an authorized healthcareprofessional under the supervision of aprogram physician, before admission tothe OTP. The full medical examination,including the results of serology andother tests, must be completed within14 days following admission.

(3) Special services for pregnantpatients. OTPs must maintain current

policies and procedures that reflect thespecial needs of patients who arepregnant. Prenatal care and other genderspecific services or pregnant patientsmust be provided either by the OTP orby referral to appropriate healthcareproviders.

(4) Initial and periodic assessmentservices. Each patient accepted fortreatment at an OTP shall be assessedinitially and periodically by qualifiedpersonnel to determine the mostappropriate combination of services andtreatment. The initial assessment mustinclude preparation of a treatment planthat includes the patient’s short-termgoals and the tasks the patient mustperform to complete the short-termgoals; the patient’s requirements foreducation, vocational rehabilitation, andemployment; and the medical,psychosocial, economic, legal, or othersupportive services that a patient needs.The treatment plan also must identifythe frequency with which these servicesare to be provided. The plan must bereviewed and updated to reflect thatpatient’s personal history, his or hercurrent needs for medical, social, andpsychological services, and his or hercurrent needs for education, vocationalrehabilitation, and employmentservices.

(5) Counseling services. (i) OTPs mustprovide adequate substance abusecounseling to each patient as clinicallynecessary. This counseling shall beprovided by a program counselor,qualified by education, training, orexperience to assess the psychologicaland sociological background of patients,to contribute to the appropriatetreatment plan for the patient and tomonitor patient progress.

(ii) OTPs must provide counseling onpreventing exposure to, and thetransmission of, humanimmunodeficiency virus (HIV) diseasefor each patient admitted or readmittedto maintenance or detoxificationtreatment.

(iii) OTPs must provide directly, orthrough referral to adequate andreasonably accessible communityresources, vocational rehabilitation,education, and employment services forpatients who either request suchservices or who have been determinedby the program staff to be in need ofsuch services.

(6) Drug abuse testing services. OTPsmust provide adequate testing oranalysis for drugs of abuse, including atleast eight random drug abuse tests peryear, per patient in maintenancetreatment, in accordance with generallyaccepted clinical practice. For patientsin short-term detoxification treatment,the OTP shall perform at least one

initial drug abuse test. For patientsreceiving long-term detoxificationtreatment, the program shall performinitial and monthly random tests oneach patient.

(g) Recordkeeping and patientconfidentiality. (1) OTPs shall establishand maintain a recordkeeping systemthat is adequate to document andmonitor patient care. This system isrequired to comply with all Federal andState reporting requirements relevant toopioid drugs approved for use intreatment of opioid addiction. Allrecords are required to be keptconfidential in accordance with allapplicable Federal and Staterequirements.

(2) OTPs shall include, as an essentialpart of the recordkeeping system,documentation in each patient’s recordthat the OTP made a good faith effort toreview whether or not the patient isenrolled any other OTP. A patientenrolled in an OTP shall not bepermitted to obtain treatment in anyother OTP except in exceptionalcircumstances. If the medical director orprogram physician of the OTP in whichthe patient is enrolled determines thatsuch exceptional circumstances exist,the patient may be granted permissionto seek treatment at another OTP,provided the justification for findingexceptional circumstances is noted inthe patient’s record both at the OTP inwhich the patient is enrolled and at theOTP that will provide the treatment.

(h) Medication administration,dispensing, and use. (1) OTPs mustensure that opioid agonist treatmentmedications are administered ordispensed only by a practitionerlicensed under the appropriate State lawand registered under the appropriateState and Federal laws to administer ordispense opioid drugs, or by an agent ofsuch a practitioner, supervised by andunder the order of the licensedpractitioner. This agent is required to bea pharmacist, registered nurse, orlicensed practical nurse, or any otherhealthcare professional authorized byFederal and State law to administer ordispense opioid drugs.

(2) OTPs shall use only those opioidagonist treatment medications that areapproved by the Food and DrugAdministration under section 505 of theFederal Food, Drug, and Cosmetic Act(21 U.S.C. 355) for use in the treatmentof opioid addiction. In addition, OTPswho are fully compliant with theprotocol of an investigational use of adrug and other conditions set forth inthe application may administer a drugthat has been authorized by the Foodand Drug Administration under aninvestigational new drug application

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under section 505(i) of the FederalFood, Drug, and Cosmetic Act forinvestigational use in the treatment ofopioid addiction. Currently thefollowing opioid agonist treatmentmedications will be considered to beapproved by the Food and DrugAdministration for use in the treatmentof opioid addiction:

(i) Methadone; and(ii) Levomethadyl acetate (LAAM).(3) OTPs shall maintain current

procedures that are adequate to ensurethat the following dosage form andinitial dosing requirements are met:

(i) Methadone shall be administeredor dispensed only in oral form and shallbe formulated in such a way as toreduce its potential for parenteral abuse.

(ii) For each new patient enrolled ina program, the initial dose of methadoneshall not exceed 30 milligrams and thetotal dose for the first day shall notexceed 40 milligrams, unless theprogram physician documents in thepatient’s record that 40 milligrams didnot suppress opiate abstinencesymptoms.

(4) OTPs shall maintain currentprocedures adequate to ensure that eachopioid agonist treatment medicationused by the program is administeredand dispensed in accordance with itsapproved product labeling. Dosing andadministration decisions shall be madeby a program physician familiar withthe most up-to-date product labeling.These procedures must ensure that anysignificant deviations from the approvedlabeling, including deviations withregard to dose, frequency, or theconditions of use described in theapproved labeling, are specificallydocumented in the patient’s record.

(i) Unsupervised or ‘‘take-home’’ use.To limit the potential for diversion ofopioid agonist treatment medications tothe illicit market, opioid agonisttreatment medications dispensed topatients for unsupervised use shall besubject to the following requirements.

(1) Any patient in comprehensivemaintenance treatment may receive asingle take-home dose for a day that theclinic is closed for business, includingSundays and State and Federalholidays.

(2) Treatment program decisions ondispensing opioid treatmentmedications to patients forunsupervised use beyond that set forthin paragraph (i)(1) of this section, shallbe determined by the medical director.In determining which patients may bepermitted unsupervised use, themedical director shall consider thefollowing take-home criteria indetermining whether a patient is

responsible in handling opioid drugs forunsupervised use.

(i) Absence of recent abuse of drugs(opioid or nonnarcotic), includingalcohol;

(ii) Regularity of clinic attendance;(iii) Absence of serious behavioral

problems at the clinic;(iv) Absence of known recent criminal

activity, e.g., drug dealing;(v) Stability of the patient’s home

environment and social relationships;(vi) Length of time in comprehensive

maintenance treatment;(vii) Assurance that take-home

medication can be safely stored withinthe patient’s home; and

(viii) Whether the rehabilitativebenefit the patient derived fromdecreasing the frequency of clinicattendance outweighs the potential risksof diversion.

(3) Such determinations and the basisfor such determinations consistent withthe criteria outlined in paragraph (i)(2)of this section shall be documented inthe patient’s medical record. If it isdetermined that a patient is responsiblein handling opioid drugs, the followingrestrictions apply:

(i) During the first 90 days oftreatment, the take-home supply(beyond that of paragraph (i)(1) of thissection) is limited to a single dose eachweek and the patient shall ingest allother doses under appropriatesupervision as provided for under theregulations in this subpart.

(ii) In the second 90 days of treatment,the take-home supply (beyond that ofparagraph (i)(1) of this section) is twodoses per week.

(iii) In the third 90 days of treatment,the take-home supply (beyond that ofparagraph (i)(1) of this section) is threedoses per week.

(iv) In the remaining months of thefirst year, a patient may be given amaximum 6-day supply of take-homemedication.

(v) After 1 year of continuoustreatment, a patient may be given amaximum 2-week supply of take-homemedication.

(vi) After 2 years of continuoustreatment, a patient may be given amaximum one-month supply of take-home medication, but must makemonthly visits.

(4) No medications shall be dispensedto patients in short-term detoxificationtreatment or interim maintenancetreatment for unsupervised or take-home use.

(5) OTPs must maintain currentprocedures adequate to identify the theftor diversion of take-home medications,including labeling containers with theOTP’s name, address, and telephone

number. Programs also must ensure thattake-home supplies are packaged in amanner that is designed to reduce therisk of accidental ingestion, includingchild-proof containers (see PoisonPrevention Packaging Act, Public Law91–601 (15 U.S.C. 1471 et seq.)).

(j) Interim maintenance treatment. (1)The program sponsor of a public ornonprofit private OTP may place anindividual, who is eligible for admissionto comprehensive maintenancetreatment, in interim maintenancetreatment if the individual cannot beplaced in a public or nonprofit privatecomprehensive program within areasonable geographic area and within14 days of the individual’s applicationfor admission to comprehensivemaintenance treatment. An initial and atleast two other urine screens shall betaken from interim patients during themaximum of 120 days permitted forsuch treatment. A program shallestablish and follow reasonable criteriafor establishing priorities fortransferring patients from interimmaintenance to comprehensivemaintenance treatment. These transfercriteria shall be in writing and shallinclude, at a minimum, a preference forpregnant women in admitting patientsto interim maintenance and intransferring patients from interimmaintenance to comprehensivemaintenance treatment. Interimmaintenance shall be provided in amanner consistent with all applicableFederal and State laws, includingsections 1923, 1927(a), and 1976 of thePublic Health Service Act (21 U.S.C.300x–23, 300x–27(a), and 300y–11).

(2) The program shall notify the Statehealth officer when a patient beginsinterim maintenance treatment, when apatient leaves interim maintenancetreatment, and before the date ofmandatory transfer to a comprehensiveprogram, and shall document suchnotifications.

(3) SAMHSA may revoke the interimmaintenance authorization for programsthat fail to comply with the provisionsof this paragraph (j). Likewise,SAMHSA will consider revoking theinterim maintenance authorization of aprogram if the State in which theprogram operates is not in compliancewith the provisions of § 8.11(g).

(4) All requirements forcomprehensive maintenance treatmentapply to interim maintenance treatmentwith the following exceptions:

(i) The opioid agonist treatmentmedication is required to beadministered daily under observation;

(ii) Unsupervised or ‘‘take-home’’ useis not allowed;

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(iii) An initial treatment plan andperiodic treatment plan evaluations arenot required;

(iv) A primary counselor is notrequired to be assigned to the patient;

(v) Interim maintenance cannot beprovided for longer than 120 days inany 12-month period; and

(vi) Rehabilitative, education, andother counseling services described inparagraphs (f)(4), (f)(5)(i), and (f)(5)(iii)of this section are not required to beprovided to the patient.

§ 8.13 Revocation of accreditation andaccreditation body approval.

(a) SAMHSA action followingrevocation of accreditation. If anaccreditation body revokes an OTP’saccreditation, SAMHSA may conduct aninvestigation into the reasons for therevocation. Following suchinvestigation, SAMHSA may determinethat the OTP’s certification should nolonger be in effect, at which timeSAMHSA will initiate procedures torevoke the facility’s certification inaccordance with § 8.14. Alternatively,SAMHSA may determine that anotheraction or combination of actions wouldbetter serve the public health, includingthe establishment and implementationof a corrective plan of action that willpermit the certification to continue ineffect while the OTP seeksreaccreditation.

(b) Accreditation body approval. (1) IfSAMHSA withdraws the approval of anaccreditation body under § 8.6, thecertifications of OTPs accredited bysuch body shall remain in effect for aperiod of 1 year after the date ofwithdrawal of approval of theaccreditation body, unless SAMHSAdetermines that to protect public healthor safety, or because the accreditationbody fraudulently accredited treatmentprograms, the certifications of some orall of the programs should be revoked orsuspended or that a shorter time periodshould be established for thecertifications to remain in effect.SAMHSA may extend the time in whicha certification remains in effect underthis paragraph on a case-by-case basis.

(2) Within 1 year from the date ofwithdrawal of approval of anaccreditation body, or within anyshorter period of time established bySAMHSA, OTPs currently accredited bythe accreditation body must obtainaccreditation from another accreditationbody. SAMHSA may extend the timeperiod for obtaining reaccreditation on acase-by-case basis.

§ 8.14 Suspension or revocation ofcertification.

(a) Revocation. Except as provided inparagraph (b) of this section, SAMHSAmay revoke the certification of an OTPif SAMHSA finds, after providing theprogram sponsor with notice and anopportunity for a hearing in accordancewith subpart C of this part, that theprogram sponsor, or any employee ofthe OTP:

(1) Has been found guilty ofmisrepresentation in obtaining thecertification;

(2) Has failed to comply with theFederal opioid treatment standards inany respect;

(3) Has failed to comply withreasonable requests from SAMHSA orfrom an accreditation body for records,information, reports, or materials thatare necessary to determine thecontinued eligibility of the OTP forcertification or continued compliancewith the Federal opioid treatmentstandards; or

(4) Has refused a reasonable request ofa duly designated SAMHSA inspector,Drug Enforcement Administration(DEA) Inspector, State Inspector, oraccreditation body representative forpermission to inspect the program or theprogram’s operations or its records.

(b) Suspension. Whenever SAMHSAhas reason to believe that revocationmay be required and that immediateaction is necessary to protect publichealth or safety, SAMHSA mayimmediately suspend the certification ofan OTP before holding a hearing undersubpart C of this part. SAMHSA mayimmediately suspend as well as proposerevocation of the certification of an OTPbefore holding a hearing under subpartC of this part if SAMHSA makes afinding described in paragraph (a) ofthis section and also determines that:

(1) The failure to comply with theFederal opioid treatment standardspresents an imminent danger to thepublic health or safety;

(2) The refusal to permit inspectionmakes immediate suspension necessary;or

(3) There is reason to believe that thefailure to comply with the Federalopioid treatment standards wasintentional or was associated withfraud.

(c) Written notification. In the eventthat SAMHSA suspends the certificationof an OTP in accordance with paragraph(b) of this section or proposes to revokethe certification of an OTP inaccordance with paragraph (a) of thissection, SAMHSA shall promptlyprovide the sponsor of the OTP withwritten notice of the suspension orproposed revocation by facsimile

transmission, personal service,commercial overnight delivery service,or certified mail, return receiptrequested. Such notice shall state thereasons for the action and shall statethat the OTP may seek review of theaction in accordance with theprocedures in subpart C of this part.

(d)(1) If SAMHSA suspendscertification in accordance withparagraph (b) of this section:

(i) SAMHSA will immediately notifyDEA that the OTP’s registration shouldbe suspended under 21 U.S.C. 824(d);and

(ii) SAMHSA will provide anopportunity for a hearing under subpartC of this part.

(2) Suspension of certification underparagraph (b) of this section shallremain in effect until the agencydetermines that:

(i) The basis for the suspensioncannot be substantiated;

(ii) Violations of required standardshave been corrected to the agency’ssatisfaction; or

(iii) The OTP’s certification shall berevoked.

§ 8.15 Forms.

(a) SMA–162—Application forCertification to Use Opioid AgonistTreatment Medications for OpioidTreatment.

(b) SMA–163—Application forBecoming an Accreditation Body under§ 8.3.

Subpart C—Procedures for Review ofSuspension or Proposed Revocationof OTP Certification, and of AdverseAction Regarding Withdrawal ofApproval of an Accreditation Body

§ 8.21 Applicability.The procedures in this subpart apply

when:(a) SAMHSA has notified an OTP in

writing that its certification under theregulations in subpart B of this part hasbeen suspended or that SAMHSAproposes to revoke the certification; and

(b) The OTP has, within 30 days ofthe date of the notification or within 3days of the date of the notification whenseeking an expedited review of asuspension, requested in writing anopportunity for a review of thesuspension or proposed revocation.

(c) SAMHSA has notified anaccreditation body of an adverse actiontaken regarding withdrawal of approvalof the accreditation body under theregulations in subpart A of this part; and

(d) The accreditation body has, within30 days of the date of the notification,requested in writing an opportunity fora review of the adverse action.

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§ 8.22 Definitions.

The following definitions apply tothis subpart C.

(a) Appellant means:(1) The treatment program which has

been notified of its suspension orproposed revocation of its certificationunder the regulations of this part andhas requested a review of thesuspension or proposed revocation, or

(2) The accreditation body which hasbeen notified of adverse actionregarding withdrawal of approval underthe regulations of this subpart and hasrequested a review of the adverse action.

(b) Respondent means SAMHSA.(c) Reviewing official means the

person or persons designated by theSecretary who will review thesuspension or proposed revocation. Thereviewing official may be assisted byone or more HHS officers or employeesor consultants in assessing andweighing the scientific and technicalevidence and other informationsubmitted by the appellant andrespondent on the reasons for thesuspension and proposed revocation.

§ 8.23 Limitation on issues subject toreview.

The scope of review shall be limitedto the facts relevant to any suspension,or proposed revocation, or adverseaction, the necessary interpretations ofthe facts the regulations, in the subpart,and other relevant law.

§ 8.24 Specifying who represents theparties.

The appellant’s request for reviewshall specify the name, address, andphone number of the appellant’srepresentative. In its first writtensubmission to the reviewing official, therespondent shall specify the name,address, and phone number of therespondent’s representative.

§ 8.25 Informal review and the reviewingofficial’s response.

(a) Request for review. Within 30 daysof the date of the notice of thesuspension or proposed revocation, theappellant must submit a written requestto the reviewing official seeking review,unless some other time period is agreedto by the parties. A copy must also besent to the respondent. The request forreview must include a copy of thenotice of suspension, proposedrevocation, or adverse action, a briefstatement of why the decision tosuspend, propose revocation, or take anadverse action is incorrect, and theappellant’s request for an oralpresentation, if desired.

(b) Acknowledgment. Within 5 daysafter receiving the request for review,

the reviewing official will send anacknowledgment and advise theappellant of the next steps. Thereviewing official will also send a copyof the acknowledgment to therespondent.

§ 8.26 Preparation of the review file andwritten arguments.

The appellant and the respondenteach participate in developing the filefor the reviewing official and insubmitting written arguments. Theprocedures for development of thereview file and submission of writtenargument are:

(a) Appellant’s documents and brief.Within 30 days after receiving theacknowledgment of the request forreview, the appellant shall submit to thereviewing official the following (with acopy to the respondent):

(1) A review file containing thedocuments supporting appellant’sargument, tabbed and organizedchronologically, and accompanied by anindex identifying each document. Onlyessential documents should besubmitted to the reviewing official.

(2) A written statement, not to exceed20 double-spaced pages, explaining whyrespondent’s decision to suspend orpropose revocation of appellant’scertification or to take adverse actionregarding withdrawal of approval of theaccreditation body is incorrect(appellant’s brief).

(b) Respondent’s documents andbrief. Within 30 days after receiving acopy of the acknowledgment of therequest for review, the respondent shallsubmit to the reviewing official thefollowing (with a copy to the appellant):

(1) A review file containingdocuments supporting respondent’sdecision to suspend or revokeappellant’s certification, or approval asan accreditation body, tabbed andorganized chronologically, andaccompanied by an index identifyingeach document. Only essentialdocuments should be submitted to thereviewing official.

(2) A written statement, not exceeding20 double-spaced pages in length,explaining the basis for suspension,proposed revocation, or adverse action(respondent’s brief).

(c) Reply briefs. Within 10 days afterreceiving the opposing party’ssubmission, or 20 days after receivingacknowledgment of the request forreview, whichever is later, each partymay submit a short reply not to exceed10 double-spaced pages.

(d) Cooperative efforts. Wheneverfeasible, the parties should attempt todevelop a joint review file.

(e) Excessive documentation. Thereviewing official may take anyappropriate steps to reduce excessivedocumentation, including the return ofor refusal to consider documentationfound to be irrelevant, redundant, orunnecessary.

(f) Discovery. The use ofinterrogatories, depositions, and otherforms of discovery shall not be allowed.

§ 8.27 Opportunity for oral presentation.(a) Electing oral presentation. If an

opportunity for an oral presentation isdesired, the appellant shall request it atthe time it submits its written requestfor review to the reviewing official. Thereviewing official will grant the requestif the official determines that thedecisionmaking process will besubstantially aided by oral presentationsand arguments. The reviewing officialmay also provide for an oralpresentation at the official’s owninitiative or at the request of therespondent.

(b) Presiding official. The reviewingofficial or designee will be the presidingofficial responsible for conducting theoral presentation.

(c) Preliminary conference. Thepresiding official may hold a prehearingconference (usually a telephoneconference call) to consider any of thefollowing: Simplifying and clarifyingissues; stipulations and admissions;limitations on evidence and witnessesthat will be presented at the hearing;time allotted for each witness and thehearing altogether; scheduling thehearing; and any other matter that willassist in the review process. Normally,this conference will be conductedinformally and off the record; however,the presiding official may, at thepresiding official’s discretion, produce awritten document summarizing theconference or transcribe the conference,either of which will be made a part ofthe record.

(d) Time and place of oralpresentation. The presiding official willattempt to schedule the oralpresentation within 45 days of the dateappellant’s request for review isreceived or within 15 days ofsubmission of the last reply brief,whichever is later. The oral presentationwill be held at a time and placedetermined by the presiding officialfollowing consultation with the parties.

(e) Conduct of the oral presentation.—(1) General. The presiding official isresponsible for conducting the oralpresentation. The presiding official maybe assisted by one or more HHS officersor employees or consultants inconducting the oral presentation andreviewing the evidence. While the oral

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presentation will be kept as informal aspossible, the presiding official may takeall necessary steps to ensure an orderlyproceeding.

(2) Burden of proof/standard of proof.In all cases, the respondent bears theburden of proving by a preponderanceof the evidence that its decision tosuspend, propose revocation, or takeadverse action is appropriate. Theappellant, however, has a responsibilityto respond to the respondent’sallegations with evidence and argumentto show that the respondent is incorrect.

(3) Admission of evidence. The rulesof evidence do not apply and thepresiding official will generally admitall testimonial evidence unless it isclearly irrelevant, immaterial, or undulyrepetitious. Each party may make anopening and closing statement, maypresent witnesses as agreed upon in thepre-hearing conference or otherwise,and may question the opposing party’switnesses. Since the parties have ampleopportunity to prepare the review file,a party may introduce additionaldocumentation during the oralpresentation only with the permissionof the presiding official. The presidingofficial may question witnesses directlyand take such other steps necessary toensure an effective and efficientconsideration of the evidence, includingsetting time limitations on direct andcross-examinations.

(4) Motions. The presiding officialmay rule on motions including, forexample, motions to exclude or strikeredundant or immaterial evidence,motions to dismiss the case forinsufficient evidence, or motions forsummary judgment. Except for thosemade during the hearing, all motionsand opposition to motions, includingargument, must be in writing and be nomore than 10 double-spaced pages inlength. The presiding official will set areasonable time for the party opposingthe motion to reply.

(5) Transcripts. The presiding officialshall have the oral presentationtranscribed and the transcript shall bemade a part of the record. Either partymay request a copy of the transcript andthe requesting party shall be responsiblefor paying for its copy of the transcript.

(f) Obstruction of justice or making offalse statements. Obstruction of justiceor the making of false statements by awitness or any other person may be thebasis for a criminal prosecution under18 U.S.C. 1001 or 1505.

(g) Post-hearing procedures. At thepresiding official’s discretion, thepresiding official may require or permitthe parties to submit post-hearing briefsor proposed findings and conclusions.Each party may submit comments on

any major prejudicial errors in thetranscript.

§ 8.28 Expedited procedures for review ofimmediate suspension.

(a) Applicability. When the Secretarynotifies a treatment program in writingthat its certification has beenimmediately suspended, the appellantmay request an expedited review of thesuspension and any proposedrevocation. The appellant must submitthis request in writing to the reviewingofficial within 10 days of the date theOTP received notice of the suspension.The request for review must include acopy of the suspension and anyproposed revocation, a brief statementof why the decision to suspend andpropose revocation is incorrect, and theappellant’s request for an oralpresentation, if desired. A copy of therequest for review must also be sent tothe respondent.

(b) Reviewing official’s response. Assoon as practicable after the request forreview is received, the reviewing officialwill send an acknowledgment with acopy to the respondent.

(c) Review file and briefs. Within 10days of the date the request for reviewis received, but no later than 2 daysbefore an oral presentation, each partyshall submit to the reviewing official thefollowing:

(1) A review file containing essentialdocuments relevant to the review,tabbed, indexed, and organizedchronologically; and

(2) A written statement, not to exceed20 double-spaced pages, explaining theparty’s position concerning thesuspension and any proposedrevocation. No reply brief is permitted.

(d) Oral presentation. If an oralpresentation is requested by theappellant or otherwise granted by thereviewing official in accordance with§ 8.27(a), the presiding official willattempt to schedule the oralpresentation within 20 to 30 days of thedate of appellant’s request for review ata time and place determined by thepresiding official following consultationwith the parties. The presiding officialmay hold a pre-hearing conference inaccordance with § 8.27(c) and willconduct the oral presentation inaccordance with the procedures of§§ 8.27(e), (f), and (g).

(e) Written decision. The reviewingofficial shall issue a written decisionupholding or denying the suspension orproposed revocation and will attempt toissue the decision within 7 to 10 daysof the date of the oral presentation orwithin 3 days of the date on which thetranscript is received or the date of thelast submission by either party,

whichever is later. All other provisionsset forth in § 8.33 apply.

(f) Transmission of writtencommunications. Because of theimportance of timeliness for theseexpedited procedures, all writtencommunications between the partiesand between either party and thereviewing official shall be sent byfacsimile transmission, personal service,or commercial overnight deliveryservice.

§ 8.29 Ex parte communications.Except for routine administrative and

procedural matters, a party shall notcommunicate with the reviewing orpresiding official without notice to theother party.

§ 8.30 Transmission of writtencommunications by reviewing official andcalculation of deadlines.

(a) Timely review. Because of theimportance of a timely review, thereviewing official should normallytransmit written communications toeither party by facsimile transmission,personal service, or commercialovernight delivery service, or certifiedmail, return receipt requested, in whichcase the date of transmission or dayfollowing mailing will be considered thedate of receipt. In the case ofcommunications sent by regular mail,the date of receipt will be considered 3days after the date of mailing.

(b) Due date. In counting days,include Saturdays, Sundays, andholidays. However, if a due date falls ona Saturday, Sunday, or Federal holiday,then the due date is the next Federalworking day.

§ 8.31 Authority and responsibilities of thereviewing official.

In addition to any other authorityspecified in this subpart C, thereviewing official and the presidingofficial, with respect to those authoritiesinvolving the oral presentation, shallhave the authority to issue orders;examine witnesses; take all stepsnecessary for the conduct of an orderlyhearing; rule on requests and motions;grant extensions of time for goodreasons; dismiss for failure to meetdeadlines or other requirements; orderthe parties to submit relevantinformation or witnesses; remand a casefor further action by the respondent;waive or modify these procedures in aspecific case, usually with notice to theparties; reconsider a decision of thereviewing official where a partypromptly alleges a clear error of fact orlaw; and to take any other actionnecessary to resolve disputes inaccordance with the objectives of theprocedures in this subpart.

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§ 8.32 Administrative record.The administrative record of review

consists of the review file; othersubmissions by the parties; transcriptsor other records of any meetings,conference calls, or oral presentation;evidence submitted at the oralpresentation; and orders and otherdocuments issued by the reviewing andpresiding officials.

§ 8.33 Written decision.(a) Issuance of decision. The

reviewing official shall issue a writtendecision upholding or denying thesuspension, proposed revocation, oradverse action. The decision will setforth the reasons for the decision anddescribe the basis for that decision inthe record. Furthermore, the reviewingofficial may remand the matter to therespondent for such further action as thereviewing official deems appropriate.

(b) Date of decision. The reviewingofficial will attempt to issue the

decision within 15 days of the date ofthe oral presentation, the date on whichthe transcript is received, or the date ofthe last submission by either party,whichever is later. If there is no oralpresentation, the decision will normallybe issued within 15 days of the date ofreceipt of the last reply brief. Onceissued, the reviewing official willimmediately communicate the decisionto each party.

(c) Public notice and communicationsto the Drug Enforcement Administration(DEA). (1) If the suspension andproposed revocation of OTPcertification are upheld, the revocationof certification will become effectiveimmediately and the public will benotified by publication of a notice in theFederal Register. SAMHSA will notifyDEA within 5 days that the OTP’sregistration should be revoked.

(2) If the suspension and proposedrevocation of OTP certification are

denied, the revocation will not takeeffect and the suspension will be liftedimmediately. Public notice will be givenby publication in the Federal Register.SAMHSA will notify DEA within 5 daysthat the OTP’s registration should berestored, if applicable.

§ 8.34 Court review of final administrativeaction; exhaustion of administrativeremedies.

Before any legal action is filed incourt challenging the suspension,proposed revocation, or adverse action,respondent shall exhaust administrativeremedies provided under this subpart,unless otherwise provided by Federallaw. The reviewing official’s decision,under § 8.28(e) or § 8.33(a), constitutesfinal agency action as of the date of thedecision.

[FR Doc. 01–723 Filed 1–16–01; 8:45 am]

BILLING CODE 4160–01–P

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