Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
Drug  Enforcement  Administration 
Reporting  to  the  National  Practitioner 
Data  Bank 
# SERWCE$ 
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GIBBS  BROWN
S+W    JUNE 
Inspector  General
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6 
~++ # MARCH 1997 
%> d~a  OEI-12-96-00160 OFFICE  OF INSPECTOR  GENERAL 
The mission of the Office of InspectorGeneral(OIG), as mandatedby Public Law 
95452,  is to protecttheintegrityof theDepartmentof HealthandHumanServices 
programsaswell asthehealthandwelfareof beneficiariesservedby them. Thisstatutory 
missionis carriedoutthroughanationwideprogramof audits,investigationsinspections, 
sanctions,andfraudalerts. TheInspectorGeneralinformstheSecretaryof programand 
managementproblemsandrecommendslegislative,regulatory,andopenkionalapproaches 
to correct them. 
OffIce  of Evaluation  and Inspections 
The Office of EvaluationandInspections(OEI)is one of severalcomponentsof theOffkx 
of InspectorGeneral. It conductsshort-termmanagementandprogramevaluations(called 
inspections)thatfocus on issuesof concernto theDepartment,theCongress,andthe 
public.  The inspectionreportsprovidefindingsandrecommendationson theefficiency, 
vulnerability,andeffectivenessof departmentaplrograms. 
Thisreportwaspreparedby AlanLevine, SeniorProgramSpecialist,underthedirection 
of MaryE&hClarke,StaffDirector,PlanningandCoordinationStaff. 
To obtaina copy of thisreport,call (202) 619-0480.  TABLE  OF  CONTENTS 
PAGE 
EXECUTIVE SUMMARY 
BACKGROUND  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1 
FINDINGS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3 
 
VoluntaryiWthdrawalsare  not reported . . . . . . . . . . . . . . . . . . . . . . . . .  3 
RECOMMENDATIONS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  4 
APPENDIXA:  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..  A-l  EXECUTIVE  SUMMARY

PURPOSE 
To review the Drug Enforcement Administrationreporting of adverse actions to the 
National Practitioner Data Bank. 
BACKGROUND 
Hospitalsand other healthcare organizationsuse the NationalPractitionerData Bank 
(Data Bank) to help with employment background checks of health care practitioners. 
The Data Bank includesrecords of malpracticepaymentsand adverseactionstaken 
againsthealthcare practitioners. Under currentpolicy the Drug Enforcement 
Administrationis required to report to the Data Bankhealthcare practitionerswho 
have had their Controlled Substance Act registrationnumber revoked or suspended 
because of violations of this law. 
FINDING 
This study found that the Drug Enforcement Administrationwas not reporting to the 
Data Bar&practitionerswho voluntarilygave up theirregistrationnumberwhen 
confronted with a potential adverse action againstthem.  According to Drug 
Enforcement Administrationdat~ in 1994and 1995a totalof 509and 486 
practitioners,respectively,voluntarilygaveup theirlicensesratherthanshowcause. 
RECOMMENDATION 
We recommend that the Drug Enforcement Administrationand Data Bank officials 
work together to irdcude voluntarywithdrawalsas part of adverse action reporting to 
the Data Bank. 
The Administrator of the Health Resources and Services Administration,who is 
responsible for the Data Bar& agreed.  PURPOSE 
To review the Drug Enforcement Administrationreporting of adverse actions to the 
National PractitionerData Bank. 
BACKGROUND 
National Practitioner Data Bank 
The National PractitionerData Bank (Data Bank) was establishedby the Health Care 
QualityImprovementAct (Act) of 1986as a resultof congressionalinterestin 
improvingthe qualityof medicalpeer review.  The Data Bankwould serveas a 
clearinghouseor resource to assisthospitals,Statelicensingboards, and other health 
care entitiesin conductinginvestigationsof the qualificationsof the healthcare 
practitioners they wish to hire, license, or to whom they wish to grant membership or 
clinicalprivileges. 
The Act specified the types of information that had to be reported to the Data Bank. 
The Data Bankwasto includemedical malpracticepayments,adverseactionstaken 
againstpractitionersby hospitalsand other healthcare entities,and sanctionstaken 
againstpractitionersby professional societiesandStatemedicalboards.  Although the 
statuterequired suchreportingin the privatesector, reportingby Federal agencies 
with health care programs, such as the Veterans Administration,Department of 
Defense, and Department of Health and Human Semites (HHS) was optional. 
However, the law also provided that the Drug Enforcement Administration(DEA) 
should participate under a memorandum of agreement with HHS, which would 
operate the Data Bank. 
The Data Ba~  which became operational in September 1990, is operated by the 
SystemsResearch and Applications Corporation under contract to the Public Health 
Service (PHS).  As of March 31, 1996,it contained 104,087medical malpractice 
reports and 23,177adverseaction reports involvinghealthcare practitioners. A small 
number of these adverse action reports include DEA sanctions againstdoctors.  Due 
to the fact thatDEA had not submittedanyreports since January1995, PHS officials 
were concerned and informallyasked the Office of Inspector General (OIG)  to review 
the matter. 
Reporting by the Drug Enforcement Administration 
In order to practice medicine in a particularState,a doctor mustbe licensedby that 
States medical board.  Such licensure includes the authorityto dispense regular 
prescription drugs.  However, some drugsare seen ashavingpotentialfor abuse apart 
from their use for bona fide medical purposes, and may not be prescribed without an 
1
 additional form of licensure. These drugs are called controlled substancesand are 
regulated by the Controlled SubstanceAct of 1970,which classifiesthem into five 
categories (or schedules), according to their potential for abuse.  In order to 
prescribe or dispense these drugs, a doctor, or other State licensed health care 
practitioners, must obtain (and periodically renew) a Federal Drug Enforcement 
Administrationregistrationnumber,technicallycalled a Certificateof Registration. 
In addition,some Statesthemselvesrequire a license (i.e. controlled substance 
registration) separate from the medical license for controlled substance authori~, 
other Statesdo not have thisrequirement. In theseStates,controlled substance 
authorityis part of the medicallicense.  SeparateDEA registrations,and appropriate 
State authorizations,are required for each State in which a practitioner maintainsa 
primaxyplace of business. 
As of October  1995,DEA had registrationsfor 825,000healthcare practitioners 
(including physicians,dentists,podiatrists,veterinarians,optometrists,and mid-level 
practitioners).  Registrationcostspractitioners$210andisvalidfor 3 years. The DEA 
makes availablethe namesof allregisteredpractitionersto the public throughthe 
National Technical Information Service, which is part of the Department of 
Commerce. 
Memorandum of Agreement 
Under a memorandum of agreement between DEA and HHS, DEA is to routinely 
report sanctionedpractitionersto the NationalPractitionerData Bank.  The 
agreement callsfor reportingallactionsinvolvingthe denial,suspensionor revocation 
of a registrationnumber.  This memorandumof agreementisbased on Section 432(c) 
of the Health Care QualityImprovementAct which statesthatthe HHS Secretaryand 
the Administrator of DEA  shall enter into a memorandum of agreement to provide 
for: 
...thereportingby theAdministratorto the Secretaryof informationrespecting 
physiciansand other practitionerswhose registrationto dispensecontrolled 
substanceshasbeen suspendedor revoked undersection 304of the Controlled 
SubstancesAct. 
The DEA  does not report such actions to other authorities,such as State medical 
licensing boards or the Federation of State Medical Boardsl.  However, suspensions 
or revocations are published in the Federal Registeq consequently, medical boards, 
hospitals,and other healthcare entitiescan learnabout such actionsthroughthe 
Federal Register. 
An organization  representing all State medical  licensing boards. It maintains  its own data 
base on adverse actions taken by State medical  licensing boardk 
2
 FINDING 
The Drug Enforcement AdministrationDoes Not Report PractitionersWho 
VoluntarilySurrenderTheir Certificate Of Registration 
The DEA  takes action to revoke or suspend a DEA registrationnumber when a 
practitionerviolatesthe Controlled SubstanceAct of 1970(e.g., improperlyselling 
controlled drugs).  The DEA also takessuch actionwhen a practitionerissanctioned 
by a State licensing authorityor law enforcement agency (e.g., State medical board 
revoking a license for a physicianwho sexuallyabused patients). 
When DEA  takes action againsta registrantfor violation of the Controlled Substance 
ACLseveralcourses of action are available. The DEA mayissuean Order to Show 
Cause why DEA  should not revoke, suspend or deny a practitioners registration. In 
this case, if a hearing is requested the matter is heard by an AdministrativeLaw Judge 
whose recommendation is forwarded to the Deputy Administrator. The Deputy 
Administrator renders all final determinationswhether a hearing is requested or not. 
The Final Order, which may or may not be revocation or denial, is then published in 
the Federal Register.  The registrantmay appeal the final rulingto the U.S. Circuit 
Court of Appeals.  As an alternativeto the Show Cause Order, DEA may ask the 
registrantto voluntarilysurrender his or her controlled substance registration. In these 
instances,the registrantis advisedthathe/she hasa rightto a hearingandthatthe 
surrender is voluntary.  When health care practitionersvoluntarilygive up their 
registrationnumber, they complete Form Number 104. 
According to both PHS and DEA officials, since September 1990,when the Data 
Bank opened, DEA has reported a total of about 150 actions to the Data Bank. 
However, according to D~  it annuallysanctionsabout three timesthe number of 
providers reported to the Data Bank.  These sanctionsare not reported because they 
involve health care providers who voluntarilygave up their DEA registration 
number, i.e., they signed Form Number 104. According to DEA data, in 1994 and 
1995a total of 509 and 486practitioners,respectively,voluntarilygaveup theirlicense 
rather than show cause. 
Volunta.xySurrender and Reporting by Medical Boards and Othem 
Although the memorandum of agreement between DEA and HHS, as well as Section 
432 of the Health Care Quality Improvement Act, indicate that only DEA revocations 
and suspensions must be reporte~  other sections of the Act deal differentlywith the 
voluntarysurrender issue.  Section 422 of the Act requires medical boards to report: 
...a description of the acts or omissions or other reasons (if known) for 
the revocation, suspension, or surrender of license, and such other 
informationrespectingthe circumstancesof the action or surrenderas 
the Secretary deems appropriate... 
3  Section 423 statesthathealthcare entities(i.e., hospitals,healthmaintenance 
organizations)mustreport each professional reviewaction thatadverselyaffects the 
clinicalprivilegesof a physicianfor a period of longer than30 daysincludingthe 
surrenderof clinicalprivilegesunder the following circumstances: 
...whilethe physicianis under an investigation...orin returnfor not 
conducting such an investigation... 
According to the House report on thislegislation,Congressintendedthat: 
The purpose of requiringreports even for circumstancesin which 
physicianssurrender their privileges is to ensure that health care entities 
will not resort to plea bargainsin which a physicianagrees to such a 
surrenderin returnfor the healthcare entityspromise not to inform 
other healthcare entitiesabout the circumstancesof the physicians 
surrender of privileges. While such agreements may serve the 
immediateself-interestsof the two partiesinvolved,theymayjeopardize 
the health and safety of future patients... 
Clearly,congressionalintentseemsto warrantDEA reportingof %oluntary 
withdrawals. 
DEA Position on Increased Reporting 
In discussionsabout the reporting of voluntarywithdrawals,DEA officials have 
indicated a willingnessto report such actions, provided the reporting could be 
accomplished by electronic tape or hard copy printout. The DEA also agreed to 
revise the memorandum of agreement to include the reporting of voluntarily 
withdrawalsprovided the increased reporting can be accomplished by either of these 
methods. 
RECOMMENDA~ON 
Data Bank Officials Should Work With The Drug Enforcement AdministrationTo 
Expand Reporting To Include VoluntaryWithdrawals. 
In order to assure that the Data Bank maintainsas comprehensive a data base as 
possible, Data Bank officials should work with DEA to expand DEA reporting. 
Such reporting would include only those voluntarywithdrawalsthatare the resultof 
misconduct.  For example, it should exclude those health care providers who 
voluntarilygive up their DEA registrationwhen they retire in order to avoid 
registrationcosts. 
Expansion of DEA  reporting will provide credentiallingand hiring officials with 
additional information with which to evaluate prospective employees. 
4  Since the memorandum of agreement between HHS and DEA does not now require 
the reporting of voluntarywithdrawals,the agreement should be modified accordingly. 
The agreement should specify which voluntarywithdrawalsare reportable and those 
that are not. 
The HRSA  concurred with the recommendation in the draft report and indicated that 
HRSA and DEA will work together on reporting issues. 
A copy of the HRSA response is included as Appendix A to this report. 
5
 APPENDIX  A 
A-1  z
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L  DEPARTMENT  OF HEALTH  &  HUMAN  SERVICES  f%blic Health Service 
< 
Health Resources and 
Servioas Administration 
IIECI81996  Rockvilie MD  20857 
TO:  Inspector  General,  DHHS 
nFROM:  Deputy  Administrator 
SUBJECT:	 OIG  Draft  Report:  !Il)rug  13nforceMent  Administration 
Reporting  to  the  National  Practitioner  Data  Bank,~[ 
0EI-12-96-O0160 
In  accordance  with  your  Sep~ember  6  request,  HRSA has  reviewed 
the  subject  draft  report  and  has  the  following  comments. 
OIG  Recommendation 
Data  Bank  Officials  should  work  with  the  Drug  Enforcement 
Administration  to  expand  reporting  to  include  voluntary 
withdrawals. 
HRSA Comments 
HRSA agrees  that  Data  Bank  officials  should  work  with  staff  from 
DEA to  determine  the  best  way  to  provide  the  Data  Bank~s  querying 
entities  with  access  to  DEA reports.  Data  Bank  officials  will 
neet  periodically  with  DEA staff  to  ensure  that  current  reporting 
requirements,  as  outlined  in  the  current  memorandum  of  agreement 
(MOE), are  fully  met.  In  addition,  at  these  periodic  meetings,
Data  Bank  and  DEA staff  will  discuss  other  reporting 
possibilities  and  ascertain  whether  the  current  MOA should  be 
expanded.  I  have  asked  for  a  status  report,  from  the  Division  of 
Quality  Assurance,  BHPr,  concerning  current  implementation  of  the 
MOA and  the  need  to  revise  or  amend  it.