Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

Drug Enforcement Administration 

Reporting to the National Practitioner 

Data Bank 

# SERWCE$ 

a+ %.... 

+ JUNE GIBBS BROWN SW Inspector General ~ 

s

‘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 protectthe integrityof the Departmentof Healthand HumanServices 

programsas well as thehealthandwelfare of beneficiariesservedby them. This statutory 

mission is carriedout througha nationwideprogramof audits,investigationsinspections, 

sanctions,and fraudalerts. The InspectorGeneralinforms the Secretaryof programand 

managementproblemsand recommendslegislative,regulatory,and openkionalapproaches 

to correct them. 

OffIce of Evaluation and Inspections 

The Office of EvaluationandInspections(OEI) is one of severalcomponentsof the Offkx 

of InspectorGeneral. It conductsshort-termmanagementandprogramevaluations(called 

inspections)thatfocus on issuesof concern to theDepartment,the Congress, andthe 

public. The inspectionreportsprovide findingsandrecommendationson the efficiency, 

vulnerability,andeffectivenessof departmentalprograms. 

This reportwas preparedby Alan Levine, SeniorProgramSpecialist,underthe direction 

of Mary E&h Clarke, Staff Director, PlanningandCoordinationStaff. 

To obtaina copy of thisreport, call (202) 619-0480. 
TABLE OF CONTENTS 

PAGE 

EXECUTIVE SUMMARY 

BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

� “VoluntaryWithdrawals’’are not reported . . . . . . . . . . . . . . . . . . . . . . . . . 

RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

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3 

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APPENDIXA: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. A-l 
EXECUTIVE SUMMARY


PURPOSE 

To review the Drug Enforcement Administrationreporting of adverse actions to the 

National Practitioner Data Bank. 

BACKGROUND 

Hospitals and other health care organizationsuse the National PractitionerData Bank 

(Data Bank) to help with employment background checks of health care practitioners. 

The Data Bank includes records of malpractice paymentsand adverse actions taken 

againsthealth care practitioners. Under current policy the Drug Enforcement 

Administrationis required to report to the Data Bank health care 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 their registrationnumber when 

confronted with a potential adverse action againstthem. According to Drug 

Enforcement Administrationdat~ in 1994 and 1995 a total of 509 and 486 

practitioners, respectively,voluntarilygave up their licenses rather than “show cause.” 

RECOMMENDATION 

We recommend that the Drug Enforcement Administrationand Data Bank officials 

work together to irdcude “voluntarywithdrawals”as 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 

Quality Improvement Act (Act) of 1986 as a result of congressional interestin 

improving the qualityof medical peer review. The Data Bank would serve as a 

clearinghouse or resource to assisthospitals,State licensingboards, and other health 

care entities in conducting investigationsof the qualificationsof the health care 

practitioners they wish to hire, license, or to whom they wish to grant membership or 

clinical privileges. 

The Act specified the types of information that had to be reported to the Data Bank. 

The Data Bank was to include medical malpractice payments,adverse actions taken 

againstpractitionersby hospitals and other health care entities,and sanctions taken 

againstpractitionersby professional societies and State medical boards. Although the 

statuterequired such reporting in the private sector, reporting by 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 23,177 adverse action reports involvinghealth care practitioners. A small 

number of these adverse action reports include DEA sanctions againstdoctors. Due 

to the fact that DEA had not submittedany reports 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 must be licensed by that 

State’s medical board. Such licensure includes the authorityto dispense regular 

prescription drugs. However, some drugs are seen as havingpotential for 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 substances”and 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 “Certificate of Registration.” 

In addition, some States themselvesrequire a license (i.e. “controlled substance 

registration”) separate from the medical license for controlled substance authori~, 

other States do not have this requirement. In these States,controlled substance 

authorityis part of the medical license. Separate DEA 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 825,000health care practitioners 

(including physicians,dentists,podiatrists,veterinarians,optometrists,and mid-level 

practitioners). Registration costs practitioners$210 and is valid for 3 years. The DEA 

makes available the names of all registered practitionersto the public through the 

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 sanctioned practitionersto the National PractitionerData Bank. The 

agreement calls for reporting all actions involvingthe denial, suspensionor revocation 

of a registrationnumber. This memorandum of agreementis based on Section 432(c) 

of the Health Care Quality Improvement Act which statesthatthe HHS Secretary and 

the Administrator of DEA shall enter into a memorandum of agreement to provide 

for: 

...the reporting by the Administratorto the Secretary of information respecting 

physiciansand other practitionerswhose registrationto dispense controlled 

substanceshas been suspended or revoked under section 304 of the Controlled 

Substances Act. 

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 health care entitiescan learn about such actions through the 

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

PractitionersWho 

FINDING 

The Drug Enforcement AdministrationDoes Not Report 

VoluntarilySurrenderTheir Certificate Of Registration 

The DEA takes action to revoke or suspend a DEA registrationnumber when a 

practitioner violates the Controlled SubstanceAct of 1970 (e.g., improperly selling 

controlled drugs). The DEA also takes such action when a practitioner is sanctioned 

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 

ACLseveral courses of action are available. The DEA may issue an Order to Show 

Cause why DEA should not revoke, suspend or deny a practitioner’s 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 advised that he/she has a rightto a hearing and thatthe 

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 times the number of 

providers reported to the Data Bank. These sanctionsare not reported because they 

involve health care providers who “voluntarily”gave up their DEA registration 

number, i.e., they signed Form Number 104. According to DEA data, in 1994 and 

1995 a total of 509 and 486 practitioners,respectively,voluntarilygave up their license 

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 

information respecting the circumstancesof the action or surrender as 

the Secretary deems appropriate... 

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Section 423 states thathealth care entities (i.e., hospitals,health maintenance 

organizations) must report each professional review action that adverselyaffects the 

clinical privileges of a physicianfor a period of longer than 30 days includingthe 

surrender of clinical privilegesunder the following circumstances: 

...while the physicianis under an investigation...orin return for not 

conducting such an investigation... 

According to the House report on this legislation,Congress intended that: 

The purpose of requiringreports even for circumstancesin which 

physicianssurrender their privileges is to ensure that health care entities 

will not resort to “plea bargains”in which a physicianagrees to such a 

surrender in return for the health care entity’spromise not to inform 

other health care entitiesabout the circumstancesof the physician’s 

surrender of privileges. While such agreements may serve the 

immediate self-interestsof the two parties involved, they mayjeopardize 

the health and safety of future patients... 

Clearly, congressional intent seems to warrantDEA reporting of %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 

withdrawals”provided 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 voluntarywithdrawalsthat are the result of 

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 
(~zL 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 disc”uss 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.