MeidasTouch
Jan 29, 2024
MeidasTouch host Ben Meiselas reports on the release of the Department of Defense Inspector General report on unlawful prescriptions of hard drugs in the Trump White House and how the White House became a pill-mill under Donald Trump.
Part 1 of 3
https://media.defense.gov/2024/Jan/09/2003373440/-1/-1/1/DODIG-2024-044_REDACTED%20SECURE.PDF
Report No. DODIG‑2024‑044
Inspector General
U.S. Department of Defense
JANUARY 8, 2024
Evaluation of the DoD Internal Controls Related to Patient Eligibility and Pharmaceutical Management Within the National Capital Region Executive Medicine Services
Results in Brief: Evaluation of the DoD Internal Controls Related to Patient Eligibility and Pharmaceutical Management Within the National Capital Region Executive Medicine Services
January 8, 2024
Objective
The objective of this evaluation was to determine the extent to which the DoD implemented appropriate controls for executive medicine services in the DoD’s National Capital Region related to identifying eligible patients and accounting for pharmaceuticals.
Background
In 2018, the DoD Office of Inspector General (DoD OIG) Hotline received complaints alleging that a senior military medical officer assigned to the White House Medical Unit engaged in improper medical practices. Additionally, several of the Hotline complaints were regarding the pharmaceutical practices and eligibility for care of some patients treated at DoD executive medicine facilities within the National Capital Region. In May 2018, the DoD OIG initiated an investigation of the allegations about the White House Medical Unit senior military medical officer.
In September 2019, the DoD OIG announced this evaluation to determine how executive medicine facilities within the National Capital Region, including the White House Medical Unit, implement internal controls to ensure safe pharmaceutical practices and patient eligibility. We conducted site visits to meet with key officials and observe executive medicine eligibility and pharmaceutical management practices. We interviewed over 120 officials, including interviews of hospital administrators, military medical providers, and pharmacists. We analyzed the transcripts of 70 interviews conducted by the DoD OIG Administrative Investigations (AI) Component of former White House Military Office employees who served within the White House between 2009 and 2018. This evaluation incorporates direct quotes from the testimony of these witnesses. We reviewed over 200 documents, including Federal criteria, DoD guidance, military Service policies, MTF internal standard operating procedures, and pharmacy procurement and inventory records.
For this report, we define Executive Medicine as the comprehensive primary and specialized medical care provided to senior military members (active and retired), eligible family members, and Government leaders. National Capital Region executive medicine services consist of services located at the White House Medical Unit Walter Reed National Military Medical Center, Fort Belvoir Community Hospital, DiLorenzo TRICARE Health Clinic, Fort McNair Army Health Clinic, and Andrew Rader U.S. Army Health Clinic.
Findings
We concluded that, except for the White House Medical Unit, the National Capital Region executive medicine clinics that we visited did not procure, store, or dispense controlled substances or other prescription medications; rather, they relied on full‑service military treatment facility pharmacies for all pharmaceutical support. The National Capital Region executive medicine clinics relied on full‑service base or post pharmacies for all pharmaceutical support. Additionally, other than the White House Medical Unit, the Joint Commission, an independent-health care accreditation agency, accredited all National Capital Region pharmacy operations, as required by DoD Manual 6025.13.
Conversely, the White House Medical Unit’s pharmaceutical services included the full scope of pharmacy operations, including storage and inventory, prescribing and dispensing, procurement, and disposal, and was not credentialed by any outside agency. We concluded that all phases of the White House Medical Unit’s pharmacy operations had severe and systemic problems due to the unit’s reliance on ineffective internal controls to ensure compliance with pharmacy safety standards. In addition, the Military Health System senior leaders did not oversee the White House Medical Unit’s pharmacy operation. Without oversight from qualified pharmacy staff, the White House Medical Unit’s pharmaceutical management practices may have been subject to prescribing errors and inadequate medication management, increasing the risk to the health and safety of patients treated within the unit. Additionally, the White House Medical Unit’s pharmaceutical management practices ineffectively used DoD funds by obtaining brand‑name medications instead of generic equivalents and increased the risk for the diversion of controlled substances.1 [Diversion is the unlawful distribution or use of prescription medications in any manner not intended by the prescriber.]
We found that the White House Medical Unit provided a wide range of health care and pharmaceutical services to ineligible White House staff in violation of Federal law and regulation and DoD policy. Additionally, the White House Medical Unit dispensed prescription medications, including controlled substances, to ineligible White House staff. In analyzing the testimonies of former White House Military Office employees, we found that White House Medical Unit senior leaders directed eligibility practices that did not comply with DoD guidance. This analysis also found that several former White House Medical Unit military medical providers stated that they were unable to act outside of the White House Medical Unit’s historical practices and that they were not empowered to deny requests from senior White House Medical Unit leaders. Additionally, we found that the White House Medical Unit did not follow DoD guidelines for verifying patient eligibility, and the Defense Health Agency and Service Surgeons General did not oversee the White House Medical Unit’s eligibility practices, as required by Public Law 114‑328, “National Defense Authorization Act for Fiscal Year 2017,” section 702.
As a result, the Military Health System did not bill non‑DoD beneficiaries for services rendered, and we found that the DoD funded and resourced care for an average of 6 to 20 non‑DoD beneficiary patients per week. Multiple former White House Medical Unit medical providers stated that they requested an early departure from the unit due to the unit’s practices.
Furthermore, we found that the National Capital Region Medical Directorate executive medicine facilities did not have consistent eligibility criteria for determining eligibility or access to care. This occurred because of a lack of oversight of executive medicine services. As a result, medical care was prioritized by seniority rather than medical need, which increased the risk to the health and safety of non‑executive medicine patients.
Recommendations
We recommend that the Director of the Defense Health Agency, in coordination with the White House Medical Unit Director, develop policy and procedures to manage controlled and non‑controlled medications, including, at a minimum, procurement, storage and inventory, prescribing and dispensing, and disposal.
We recommend that the Assistant Secretary of Defense (Health Affairs), in coordination with the Defense Health Agency and the Service Surgeons General, develop a pharmaceutical oversight plan for the White House Medical Unit.
We recommend that the Director of the Defense Health Agency, in coordination with the White House Medical Unit Director, establish controls for White House patient eligibility within the Military Health System.
We recommend that the Assistant Secretary of Defense (Health Affairs), in coordination with the Defense Health Agency Director and the Service Surgeons General, establish an oversight plan for the White House Medical Unit’s eligibility practices.
We recommend that the Defense Health Agency Director develop policy and an oversight plan for executive medicine services. This policy should include eligibility criteria and access to care practices for executive medicine services.
We recommend that the Defense Health Agency Director establish controls for billing and cost recovery for outpatient medical services provided to non‑military senior officials of the U.S. Government, as outlined in the Code of Federal Regulations.
Please see the Recommendations Table on the next page for the status of recommendations.
Management Comments and Our Response
The Assistant Secretary of Defense (Health Affairs) agreed with the recommendations and described the actions they plan to take to address the recommendations. The Assistant Secretary also agreed with the recommendations directed to the DHA Director, on their behalf. The Assistant Secretary’s planned actions meet the intent of the recommendations.
Therefore, the recommendations are resolved and will remain open until we verify that the actions were taken. Please see the Recommendations Table on the next page for the status of recommendations.
Recommendations Table
Management / Recommendations Unresolved / Recommendations Resolved / Recommendations Closed
Assistant Secretary of Defense for Health Affairs / None / A.2.a., A.2.b, A.2.c, A.2.d, A.2.e, B.2 / None
Defense Health Agency Director / None / A.1, A.2.a., A.2.b, A.2.c, A.2.d, A.2.e, B.1, B.2, C.1, C.2 / None
Note: The following categories are used to describe agency management’s comments to individual recommendations.
• Unresolved – Management has not agreed to implement the recommendation or has not proposed actions that will address the recommendation.
• Resolved – Management agreed to implement the recommendation or has proposed actions that will address the underlying finding that generated the recommendation.
• Closed – The DoD OIG verified that the agreed upon corrective actions were implemented.
***
OFFICE OF INSPECTOR GENERAL
DEPARTMENT OF DEFENSE
4800 MARK CENTER DRIVE
ALEXANDRIA, VIRGINIA 22350‑1500
January 8, 2024
MEMORANDUM FOR ASSISTANT SECRETARY OF DEFENSE (HEALTH AFFAIRS) DIRECTOR, DEFENSE HEALTH AGENCY DIRECTOR, WHITE HOUSE MEDICAL UNIT
SUBJECT: Evaluation of the DoD Internal Controls Related to Patient Eligibility and Pharmaceutical Management Within the National Capital Region Executive Medicine Services (Report No. DODIG‑2024‑044)
This final report provides the results of the DoD Office of Inspector General’s evaluation. We previously provided copies of the draft report and requested written comments on the recommendations. We considered management’s comments on the draft report when preparing the final report. These comments are included in the report.
A draft of this report was under review by the White House Military Office from May 2020 to July 2023. During this time we maintained contact with the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency, and the White House Military Office to provide updates on the status of the report. This final report includes our findings and recommendations.
The Assistant Secretary of Defense (Health Affairs) agreed to address all the recommendations presented in the report; therefore, we consider the recommendations resolved and open. We will close the recommendations when you provide us documentation showing that all agreed‑upon actions to implement the recommendations are completed. Therefore, please provide us your response concerning specific actions in process or completed on the recommendations within 90 days. Send your response to either [DELETE] if classified SECRET.
We appreciate the cooperation and assistance received during the evaluation. If you have any questions, please contact [DELETE]
FOR THE INSPECTOR GENERAL:
Michael J. Roark
Deputy Inspector General for Evaluations
***
Contents
Introduction
Objective ...........1
Background .....1
Findings
Finding A. The White House Medical Unit Pharmaceutical Management Practices Did Not Comply with Federal and DoD Guidance ..............6
The White House Medical Unit Pharmaceutical Management Practices Did Not Comply with Federal and DoD Guidance, While All Other NCR Executive Medicine Clinics’ Pharmaceutical Practices Complied with Federal and DoD Guidance .....8
The White House Medical Unit Lacked Effective Internal Controls to Ensure Compliance With Safety Standards Throughout Its Pharmaceutical Practices ...22
Senior Military Health System Leaders Did Not Provide Oversight of the White House Medical Unit’s Pharmacy Operations .........23
The White House Medical Unit Pharmaceutical Management Practices Increased the Risk to Patient Health and Safety and the Risk of Diversion of Controlled Substances ...25
Recommendations, Management Comments, and Our Response ......29
Finding B. The White House Medical Unit Routinely Provided Free Medical Care to Ineligible White House Staff in Violation of Federal Law and DoD Guidance .....31
The White House Medical Unit Routinely Provided Free Medical Care to Ineligible White House Staff in Violation of Federal Law and DoD Guidance .... 32
The White House Medical Unit’s Senior Leaders Directed Eligibility Practices That Did Not Comply with DoD Guidance ........37
The MHS Did Not Bill Ineligible Patients for Services Rendered Within the DoD Health Care System ..........40
Recommendations, Management Comments, and Our Response .......41
Finding C. The Defense Health Agency Did Not Establish Policies, Procedures, and Guidance for Executive Medicine Services Within the National Capital Region Medical Directorate ...... 43
The Defense Health Agency Did Not Establish Policies, Procedures, and Guidance for Executive Medicine Services Within the National Capital Region Medical Directorate ...... 44
The Military Health System Is at Risk for Expending Resources on Medical Activities Outside of Its Primary Mission ..... 54
Recommendations, Management Comments, and Our Response ...... 55
Appendix
Scope and Methodology ........... 57
Criteria for Executive Medicine ....... 58
Use of Computer‑Processed Data ......61
Prior Coverage ........ 6
Management Comments
Assistant Secretary of Defense (Health Affairs) ............ 63
Acronyms and Abbreviations 64
Glossary ............. 65
***
Introduction
Objective
The objective of this evaluation was to determine the extent to which the DoD implemented appropriate controls for executive medicine services in the DoD’s National Capital Region (NCR) related to identifying eligible patients and accounting for pharmaceuticals.
Background
In 2018, the DoD Office of Inspector General (DoD OIG) Hotline received complaints alleging that a senior military medical officer assigned to the White House Medical Unit engaged in improper medical practices. Additionally, several Hotline complaints were made regarding the pharmaceutical practices and eligibility for care of some patients treated at DoD executive medicine facilities within the NCR.
In May 2018, the DoD OIG initiated an investigation of the allegations regarding the White House Medical Unit senior military medical officer. Subsequently, in September 2019, the DoD OIG initiated this evaluation to examine how executive medicine facilities within the NCR, including the White House Medical Unit, implemented internal controls to ensure safe pharmaceutical practices and patient eligibility. We interviewed Defense Health Agency (DHA) and National Capital Region Medical Directorate (NCRMD) executive medicine and senior pharmacy officials. We conducted site visits at pharmacies, primary care facilities, and executive medicine facilities at the White House Medical Unit, Walter Reed National Military Medical Center, Fort Belvoir Community Hospital, DiLorenzo TRICARE Health Clinic, Fort McNair Army Health Clinic, and Andrew Rader U.S. Army Health Clinic. Additionally, we analyzed the transcripts of 70 interviews conducted by DoD OIG Administrative Investigations (AI) team members with former White House Military Office employees who served within the White House between 2009 and 2018. This evaluation incorporates direct quotes from the testimony of these witnesses.
Governance and Administration of Medical Operations Within the National Capital Region
The Military Health System (MHS) is the DoD’s global health system that provides health care services and support to active duty Service members, military retirees, and their eligible family members. The Office of the Assistant Secretary of Defense for Health Affairs (ASD[HA]) manages health policy and budgeting across the Military Health System and directs the activities of the DHA.
In 2013, the Secretary of Defense directed the establishment of the DHA as part of the DoD’s effort to reform the MHS. The DHA supports the delivery of health care services to DoD beneficiaries and integrates clinical and business processes across the MHS. The DHA also manages the TRICARE health care plan, which provides comprehensive medical coverage to uniformed Service members, military retirees, and their families. The DHA develops guidance and regulations, as required, to manage TRICARE and to support the ASD(HA) in administration of all DoD medical and dental programs.
The National Capital Region Medical Directorate (NCRMD) is a directorate of the DHA and manages integrated health care delivery at MTFs within the NCR. The NCRMD exercises authority, direction, and control over Walter Reed National Military Medical Center (Walter Reed), Fort Belvoir Community Hospital, and Walter Reed and Fort Belvoir Community Hospital subordinate clinics, which includes the DiLorenzo TRICARE Health Clinic (DiLorenzo).2 [On January 30, 2020, the DHA disestablished the NCRMD and implemented the National Capital Region Market. The Market Director oversees, manages, and directs all health care delivery of the Military Medical Treatment Facilities and Dental Treatment Facilities in the National Capital Region Market.]
The Army, Navy, and Air Force Surgeons General serve as the principal advisors on all health and medical matters for their respective Services. In addition, the Service Surgeons General serve as medical advisors to the DHA Director on matters pertaining to military health readiness requirements and safety of their Service members.
Executive Medicine Services in the National Capital Region
Executive medicine within the DoD developed out of a need to provide focused medical care for flag and general officers that ensures the availability, security, and confidentiality of health care services for these senior leaders. Although executive medicine is not defined in DoD or MHS guidance, DoD health care officials generally described executive medicine as comprehensive primary and specialized medical care provided to senior Service members (active and retired), eligible family members, and senior Government leaders who are authorized to receive medical care under title 32 of the Code of Federal Regulations. According to DoD health care officials, as their responsibilities increased, senior military officers found themselves with less time and opportunity to tend to their health care needs. Additionally, medical providers stated that the presence of high‑ranking officers at military treatment facilities frequently disrupted medical care provision to the general population. Executive medicine facilities were created to provide coordinated care to accommodate senior leaders’ professional and personal schedules and to allow medical treatment facilities to provide uninterrupted routine medical care to other beneficiaries.
Since 1946, U.S. presidents, Cabinet secretaries, and top military leaders have received private, very important person (VIP) medical treatment within the NCR at either the National Naval Medical Center or the Walter Reed Army Medical Center.3 [In 2011, because of the Base Realignment and Closure Act, the National Naval Medical Center and the Walter Reed Army Medical Center were merged to create the Walter Reed National Military Medical Center.] Franklin Roosevelt was the first President to be seen at the National Naval Medical Center, which would later be known as the “President’s Hospital.” In 1977, a secure facility called the Eisenhower Executive Nursing Unit was established at the Walter Reed Army Medical Center to treat not only the President, but also high‑ranking military and Government officials. Now, these executive medicine services are provided at Walter Reed, Fort Belvoir Community Hospital, DiLorenzo TRICARE Health Clinic, Fort McNair Army Health Clinic, Andrew Rader U.S. Army Health Clinic, and the White House Medical Unit. However, the eligible population has expanded to include family members of active duty flag and general officers, retired flag and general officers and their families, and retired military who are now Senior Executive Service leaders and their families.
Walter Reed National Military Medical Center Executive Medicine
The Walter Reed Executive Medicine Clinic provides personalized health care to senior military and Government leaders, including coordination with other health care providers for preventive and specialty care. Walter Reed does not have written guidance that establishes eligibility for executive medicine services. However, Walter Reed’s official website identified the following categories of Government officials as eligible for its executive medicine services:
• Active duty and retired flag and general officers and their beneficiaries
• Current Senior Executive Service personnel that are retired service members
• Members of the President’s Cabinet
• Members of the U.S. Congress
• U.S. Supreme Court Justices
• The Secretary, Deputy Secretary, and Assistant Secretaries of Defense and the Military Departments
Fort Belvoir Community Hospital Executive Medicine
The Fort Belvoir Community Hospital Executive Medicine Health and Wellness Clinic provides care for “authorized individuals, general officers of the armed services, and their eligible family members.” Fort Belvoir Community Hospital also provides assistance with the specialty referral process and expedites administrative paperwork for its patient population. Fort Belvoir Community Hospital’s eligible population mirrors that of Walter Reed. However, Fort Belvoir Community Hospital Administrative Instruction 6010.03 also designated the following individuals as eligible for its executive medicine services:
• Foreign military flag officers and their family members (including personnel from North Atlantic Treaty Organization members and allied nations with orders);
• the Sergeant Major of the Army, Master Chief Petty Officer of the Navy, Sergeant Major of the Marine Corps, Chief Master Sergeant of the Air Force, Master Chief Petty Officer of the Coast Guard, and their family members; and
• Medal of Honor recipients and their family members.
DiLorenzo TRICARE Health Clinic Executive Medicine
The DiLorenzo Executive Medicine Clinic is a subordinate facility of the Fort Belvoir Community Hospital. The clinic provides care to active duty and retired flag and general officers, current Senior Executive Service personnel that are retired service members, and individuals designated by the Fort Belvoir Community Hospital Director or the DiLorenzo Clinic Director as eligible for care. The clinic also arranges patient referrals with sub‑specialty clinics within the National Capital Region.
Fort McNair and Andrew Rader Executive Medicine
The Director of the National Capital Region Medical Directorate exercises enhanced Multi‑Service Market (eMSM) authorities over both Andrew Rader U.S. Army Health Clinic and Fort McNair Army Health Clinic. Fort McNair Army Health Clinic and Andrew Rader U.S. Army Health Clinic do not operate executive medicine clinics that are separate from the general medical treatment facility; however, both facilities offer specialized primary care services to general officers, flag officers, and their family members. Although the executive medicine patients are part of the general clinic population, they still receive coordinated care to accommodate their professional and personal schedules, similar to those patients who are seen at executive medicine clinics independent from the general treatment facility.
White House Medical Unit
The White House Medical Unit is a Joint Service military unit under the authority of the White House Military Office and was established in the West Wing in 1945. White House Medical Unit staff members are military and DoD civilian employees selected by the Executive Secretary of the Department of Defense. The staff is composed of physicians, physician assistants, nurses, clinical psychologists, administrators, and medics, and has tripled in size over the past 15 years. In 2019, the unit reported 60 medical personnel on staff, up from 20 medical personnel in 2005. White House Medical Unit officials stated that the Navy Bureau of Medicine and Surgery (BUMED) medical policies govern the White House Medical Unit’s medical practices. According to a BUMED historian, “Navy medical personnel have played an integral role in developing the very concept of the White House Medical Unit and defining the field of “Chief Executive Medicine.”4 [Sobocinski, André B., “Ten Curious Facts about Navy Medicine’s Presidential History,” HTTPS://NAVYMEDICINE. NAVYLIVE.DODLIVE.MIL/ARCHIVES/8049, accessed March 10, 2020.]
The White House Medical Unit comprises several medical clinics, including facilities at the Eisenhower Executive Office Building (EEOB), the New Executive Office Building (NEOB), the White House Communications Agency (WHCA), the White House Residence Clinic, the Medical Evaluation and Treatment Team at Walter Reed National Military Medical Center, and travel medicine for official travel. The primary mission of the White House Medical Unit is to complete all mission‑essential tasks related to the health and safety of the President and Vice‑President of the United States. The secondary mission of the White House Medical Unit is to ensure the health and safety of all individuals on the White House 18‑acre compound. The White House Medical Unit Executive Medicine Program provides special medical access to the Presidential Cabinet and Assistants to the President under the Secretarial Designee Program.5 [The Secretarial Designee Program establishes an eligibility for health care services in military treatment facilities for individuals who do not have pre-established eligibility.] Executive medical care consists of annual physicals, preventive medical care, acute medical care, travel medicine, vaccinations, wellness evaluations, pharmaceutical services, diagnostic procedures, and specialty consultation services.
Finding A
The White House Medical Unit Pharmaceutical Management Practices Did Not Comply with Federal and DoD Guidance
We concluded that, except for the White House Medical Unit, the NCR executive medicine clinics that we visited did not procure, store, or dispense controlled substances or other prescription medications. The NCR executive medicine clinics relied on full MTF pharmacies for all pharmaceutical support. These MTF pharmacies were accredited by the Joint Commission, as required by DoD Manual 6025.13.6 [DoD Manual 6025.13, “Medical Quality Assurance and Clinical Quality Management,” October 29, 2013.] Conversely, the White House Medical Unit’s pharmaceutical services, which were not accredited by the Joint Commission or any other outside agency, included the full scope of pharmacy operations, consisting of storage and inventory, prescribing and dispensing, procurement, and disposal. Additionally, we found that all phases of the White House Medical Unit’s pharmacy operations had severe and systemic problems. Specifically, we concluded that the White House Medical Unit implemented:
• Storage and inventory processes that were ineffective. In our analysis of the White House Medical Unit’s controlled substance records, we found that medications, such as opioids and sleep medications, were not properly accounted for, in violation of title 21 Code of Federal Regulations (CFR) section 1304.22 (2019).7 [Unit doses include tablets, vials, patches, and lozenges.] In addition, the White House Medical Unit used handwritten records to track the inventory of controlled substances. These records frequently contained errors in the medication counts, illegible text, or crossed out text that was not appropriately annotated.
• Prescribing practices that did not comply with the Code of Federal Regulations and Drug Enforcement Administration (DEA) policy, 21 CFR sec. 1306 (2019).8 [Title 21, chapter 2 of the Code of Federal Regulations establishes the roles and responsibilities of the DEA in the manufacture and distribution of controlled substances.] White House Medical Unit medical providers wrote prescriptions for controlled substances that often lacked the medical provider and patient information mandated by DEA policy.
• Dispensing practices that did not comply with Navy Manual of the Medical Department, NAVMED P‑117. NAVMED P‑117 requires that prescriptions be filled only for eligible beneficiaries with a valid identification check, and the guidance prohibits dispensing over the counter medications, such as Tylenol and cold medications, without a prescription. The White House Medical Unit dispensed non‑emergency controlled medications, such as Ambien and Provigil, without verifying the patient’s identity.9 [Ambien is a sedative medication used to treat insomnia, and Provigil is a stimulant medication used to promote wakefulness.] The White House Medical Unit also left over‑the‑counter medications in open bins for patient retrieval and use.
• Medication procurement practices that did not comply with 32 CFR sec. 199.21 (2019), which establishes requirements for the TRICARE Pharmacy Benefits Program. The regulation states that the “pharmacy benefits program generally requires mandatory substitution of generic drugs … for brand name drugs.” The White House Medical Unit routinely requested brand‑name drugs rather than generic equivalents when ordering controlled substances from Walter Reed. For example, over a 3‑year period, the White House Medical Unit spent an estimated $46,500 for brand name Ambien, which is 174 times more expensive than the generic equivalent. Over the same period, the White House Medical Unit also spent an estimated $98,000 for brand name Provigil, which is 55 times more expensive than the generic equivalent.
• Medication disposal practices that did not comply with Federal and Service policy. For example, 21 CFR Part 1317 (2019) requires the use of a reverse distributor, or on‑site destruction of controlled substances that renders the medication non‑retrievable. When disposing of controlled substances, the White House Medical Unit did not employ a reverse distributor or render the medications non‑retrievable, as required by the CFR. Additionally, the White House Medical Unit improperly disposed of both controlled and non‑controlled substances in sharps containers, which violates Service guidance.10 [Sharps containers are rigid, leak-proof plastic containers used to dispose of medical sharps, such as needles and syringes.] The Navy Pharmacy Advisory Board prohibits the disposal of medication in sharps containers and requires the use of specific pharmaceutical waste containers for medication disposal.
We concluded that these problems occurred because White House Medical Unit officials did not consider their operations to be a pharmacy and, therefore, relied on internal White House Medical Unit controls to ensure compliance with safety standards throughout its pharmaceutical practices. We concluded that the White House Medical Unit’s internal controls were ineffective. In addition, senior officials at the DHA and the Service Surgeons General stated that they did not provide oversight of the White House Medical Unit’s pharmacy operations and did not establish which organization would exercise primary authority for oversight of the White House Medical Unit.
Without oversight from qualified pharmacy staff, the White House Medical Unit’s pharmaceutical management practices might have been subject to prescribing errors. Additionally, the White House Medical Unit’s practices demonstrated inadequate medication management and increased risk to the health and safety of patients treated within the unit. Additionally, the White House Medical Unit’s pharmaceutical management practices ineffectively used DoD funds to purchase brand‑name medications instead of generic equivalents; this increased the risk for the diversion of controlled substances by not accounting for them appropriately.11 [Diversion is the unlawful distribution or use of prescription medications in any manner not intended by the prescriber.]
The White House Medical Unit Pharmaceutical Management Practices Did Not Comply with Federal and DoD Guidance, While All Other NCR Executive Medicine Clinics’ Pharmaceutical Practices Complied with Federal and DoD Guidance
We concluded that, except for the White House Medical Unit, the NCR executive medicine clinics did not procure, store, or dispense controlled substances or other prescription medications; rather, they relied on full‑service MTF pharmacies for all pharmaceutical support. We interviewed DHA and NCR executive medicine and senior pharmacy officials, and we conducted site visits at pharmacies, primary care facilities, and executive medicine facilities at the White House Medical Unit, Walter Reed National Military Medical Center, Fort Belvoir Community Hospital, DiLorenzo TRICARE Health Clinic, Fort McNair Army Health Clinic, and Andrew Rader U.S. Army Health Clinic. We found that full‑service MTF pharmacies provided all pharmaceutical support for the NCR executive medicine clinics, except the White House Medical Unit. Additionally, executive medicine clinics had limited stocks of pharmaceutical medication stored within their local electronic medication storage units. The MTF pharmacy maintained responsibility for inventorying all medications in the local electronic medication storage units. None of the executive medicine clinics stored controlled medications within the clinic. Executive medicine providers stated that they never fill prescriptions within the clinic; rather, all prescriptions for medications were entered into the patient’s official electronic medical record. Executive medicine patients were required to retrieve their medication at the MTF pharmacy. With the exception of the WHMU’s pharmaceutical operations, the Joint Commission accredited all NCR pharmacy operations, as required by DoD Manual 6025.13.12 [DoD Manual 6025.13, “Medical Quality Assurance and Clinical Quality Management,” October 29, 2013.]
On the other hand, the White House Medical Unit’s pharmaceutical services included the full scope of pharmacy operations, which includes storage and inventory, prescribing and dispensing, procurement, and disposal. The White House Medical Unit’s clinical and pharmaceutical operations were not credentialed by an outside agency. We concluded that all phases of the White House Medical Unit’s pharmacy operations had severe and systemic problems due to the unit’s reliance on ineffective internal controls to ensure compliance with pharmacy safety standards. In addition, senior officials at the DHA and the Offices of the Service Surgeons General did not provide oversight of the White House Medical Unit’s pharmacy operations, as required by Public Law 114‑328, “National Defense Authorization Act for Fiscal Year 2017,” section 702.
The White House Medical Unit’s Internal Controls for Pharmacy Operations Did Not Comply with Federal and DoD Guidelines
The White House Medical Unit conducted pharmacy operations with internal controls that did not comply with Federal Regulations and DoD guidelines. We interviewed White House Medical Unit senior leaders, reviewed White House Medical Unit’s pharmacy operations policy and records, and conducted site visits at the White House Medical Unit’s Eisenhower Executive Office Building, New Executive Office Building, and White House Communication Agency clinics. White House Medical Unit officials emphasized that the White House Medical Unit does not operate a true pharmacy, stating that the unit does not handle a large enough volume of pharmaceuticals to qualify as a pharmacy or to require a full time pharmacist. We did not find DoD guidance that outlines the volume of pharmaceutical services that would require a full time pharmacist. However, we concluded that while the White House Medical Unit may be performing a smaller number of pharmaceutical tasks, those tasks entail the full universe of pharmaceutical operations. During our site visits, we observed White House Medical Unit staff performing tasks customarily associated with those of a pharmacy, such as ordering and storing a variety of prescription and non‑prescription medications and dispensing medications to patients in conventional, amber‑colored pill bottles that were marked “White House Medical Unit” (see Figure 1). Additionally, at the WHCA clinic, we observed a sign that read “Pharmacy” outside a room housing the MedSelect unit.
Although the DoD does not define the term “pharmacy” in any of its published guidance, we concluded that White House Medical Unit’s pharmaceutical operations sufficiently resembled those of a traditional pharmacy, and we evaluated them against pharmaceutical‑related DoD policies and Federal regulations. Our analysis of White House Medical Unit pharmaceutical operations showed that the White House Medical Unit implemented:
• storage and inventory processes that were ineffective;
• prescribing practices that did not comply with the Code of Federal Regulations and DEA policy, 21 CFR sec. 1306 (2019), to include specific patient and provider information;
• dispensing practices that did not comply with Service guidance to maintain records of medications dispensed and to restrict access to over‑the‑counter medications;
• medication procurement practices that did not comply with TRICARE policy to purchase generic medications when available; and
• medication disposal practices that did not comply with Federal and Navy policies to either use the services of a reverse distributor or to render the medications non‑retrievable.
Additionally, White House Medical Unit officials stated that the unit receives its funding from the Navy Bureau of Medicine and Surgery (BUMED) and that BUMED policies govern White House Medical Unit practices. Therefore, we also applied relevant Navy policy and guidance to our evaluation of White House Medical Unit operations.
[x]
Figure 1. White House Medical Unit Pill Bottle Source: The DoD OIG.
The White House Medical Unit Implemented Storage and Inventory Processes That Were Not Effective
The White House Medical Unit operated a pharmacy with storage and inventory processes that did not comply with Federal Regulations and DoD guidelines for pharmacy operations. We examined records and storage of medications, including controlled substance medications, at the White House Medical Unit. Controlled prescription medications (controlled substances) are a special class of drugs regulated by the DEA under the authority of the Controlled Substances Act.13 [Public Law 91-513, “Comprehensive Drug Abuse Prevention and Control Act of 1970,” October 27, 1970.] All legitimate handlers of controlled substances (such as manufacturers, distributors, physicians, pharmacies, and researchers) must be registered with the DEA (as was the White House Medical Unit) and maintain strict accounting for all distributions.
SCHEDULES OF CONTROLLED SUBSTANCES
The Controlled Substances Act regulates five classes of drugs: narcotics (opioids), depressants, stimulants, hallucinogens, and anabolic steroids.14 [The DEA assigns the same meaning to the terms “narcotic” and “opioid;” for this evaluation, we use the term “opioid.”] The Act places these drugs into one of five schedules (I, II, III, IV, and V) based on the drug’s medical use, potential for abuse, and potential for physical or psychological dependence:
• Schedule I: These drugs have a high potential for abuse and no currently accepted medical treatment use in the United States.
• Schedule II: These drugs have a high potential for abuse that may lead to severe psychological or physical dependence. They have an accepted medical treatment use in the United States with severe restrictions. Schedule II includes opioid pain medications.
• Schedule III: These drugs have a potential for abuse less than those drugs in Schedules I and II and may lead to moderate psychological or physical dependence. They have an accepted medical treatment use in the United States.
• Schedules IV and V: These drugs have a low potential for abuse and may lead to limited psychological or physical dependence. They have an accepted medical treatment use in the United States.
TYPES OF MEDICATIONS MAINTAINED AT THE WHITE HOUSE MEDICAL UNIT
We visited three clinics at White House offices in the NCR that store prescription medications: The Eisenhower Executive Office Building (EEOB), the New Executive Office Building (NEOB), and the White House Communication Agency (WHCA). White House Medical Unit officials stated that the EEOB clinic served as the central facility for receipt and storage of White House Medical Unit’s inventory of non‑prescription and prescription medications. White House Medical Unit staff distributed controlled substances from the EEOB to all other White House Medical Unit clinics. Some examples of non‑prescription medications in the White House Medical Unit’s standard inventory supply include allergy, pain relief, and cold and flu medications. Prescription medications are classified as either non‑controlled or controlled medications. Non‑controlled prescription medications include antibiotic, anti‑inflammatory, and asthma medications.
FEDERAL RECORD‑KEEPING REQUIREMENTS FOR CONTROLLED SUBSTANCES
The Code of Federal Regulations requires that all persons who manufacture, distribute, or dispense controlled substances obtain a registration number from the DEA. These registration numbers allow the DEA to trace controlled substances from initial manufacture through final dispensing to the patient. The CFR also requires that registered pharmacies maintain inventories and records of Schedule II controlled substances separately from all other pharmacy records.15 [21 CFR SEC. 1304.04 (2019).] DEA registrants must also maintain an inventory record that lists the number of controlled substance units distributed or disposed of, including the date and manner of distribution or disposal.
On September 24, 2019, we sent a request for information to Walter Reed and White House Medical Unit officials for five years of data (January 1, 2014, through December 31, 2018) related to the ordering, storing, dispensing, and accounting for controlled medications. White House Medical Unit officials stated that the unit only maintains pharmaceutical records for two years and provided us with data from 2017 to 2019. Walter Reed Pharmacy also provided us with the White House Medical Unit’s controlled substance requisition records from 2017 to 2019. Additionally, in January 2020, we requested that NCRMD pharmacy officials provide five years of data (January 1, 2014, through December 31, 2018) on all medications obtained under the White House Medical Unit’s DEA number. NCRMD pharmacy officials stated that, due to system limitations, they were only able to provide two years of data (February 2018 to February 2020) from a DoD pharmaceutical supplier.
We used data provided by the NCRMD, Walter Reed, and the White House Medical Unit to generate a list of all medications ordered by the White House Medical Unit. We also used tracking forms provided by the White House Medical Unit to generate a list of all controlled substances received from Walter Reed Pharmacy. We also used inventory forms provided by the White House Medical Unit to generate a list of controlled substances that the White House Medical Unit dispensed or disposed of. We then analyzed these lists to assess the White House Medical Unit’s controlled substance inventory tracking process and the accuracy of its inventory records.
The Code of Federal Regulations requires that registered pharmacies maintain inventories and records of Schedule II controlled substances separately from all other pharmacy records.16 [21 CFR sec. 1304.04 (2019).] In our site visit to the EEOB Clinic, we concluded that the clinic maintained the controlled substance inventory records in a binder on hand‑written paper logs, stored in the EEOB clinic’s medication dispensing area. The inventory records showed that White House Medical Unit stocked four different types of Schedule II opioid pain medications (fentanyl, hydrocodone, morphine, and oxycodone), as well as medications from Schedules III through V, such as stimulants and sedatives. However, White House Medical Unit kept the records for its Schedule II medications in the EEOB’s inventory binder together with records for all other controlled medications and not maintained separately as required by the CFR.
The Code of Federal Regulations also requires that registrants’ inventory records list the number of controlled substance units distributed or disposed of, including the date and manner of distribution or disposal.17 [21 CFR sec. 1304.22 (2019).] White House Medical Unit staff used a medication receipt log, called CSIB (Controlled Substance Inventory Board) Receipt Tracking, to record the receipt of controlled substance orders at the EEOB. The receipt log records the number of medication units ordered and the number of medication units actually received. They also used an inventory log, called the Narcotic and Controlled Drug Account Record (NAVMED form), to track each controlled substance order by unit.18 [NAVMED Form 6710/1, “Narcotic and Controlled Drug Account Record”, January 2002.] The inventory log records the number of medication units dispensed to patients, distributed to other White House Medical Unit clinics, or disposed of, accounting for the total number of units received.
In our analysis of White House Medical Unit’s inventory records, we concluded that White House Medical Unit’s controlled substance records did not accurately reflect the unit’s procurement, inventory, or disposal of controlled substances.
As shown in the White House Medical Unit Controlled Substance Requisition form (Figure 2) and the White House Medical Unit Controlled Substance Receipt Tracking form (Figure 3), the White House Medical Unit’s hand‑written inventory logs frequently contained errors in the medication counts, illegible text, or crossed out text that was not appropriately annotated, making it hard to accurately track the disposition of controlled substances. A DHA pharmacy official also stated that the DHA did not have oversight of the controlled medications that Walter Reed supplied to the White House Medical Unit.
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Figure 2. Sample of the White House Medical Unit Controlled Substance Requisition Form Source: White House Medical Unit.[/b]
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[i]Figure 3. Sample of the White House Medical Unit Controlled Substance Receipt Tracking Form Source: White House Medical Unit.
We observed that each White House Medical Unit clinic used an automated medication dispensing cabinet called MedSelect to store both controlled and non‑controlled medications, with the two types of medications stored in separate modules of the dispensing cabinet. At the three clinics, we observed the process for retrieving non‑controlled medications from the MedSelect, as well as the process for dispensing medications to patients. We observed the retrieval process for controlled medications only at the EEOB clinic, as White House Medical Unit officials stated that they did not store or distribute controlled medications at the NEOB and WHCA clinics. However, we could not verify the contents of the controlled substance module in the MedSelect at the NEOB or the WHCA. This was because officials at the WHCA clinic stated that staff were unable to open the controlled medication storage drawers and stated that the drawers were empty.
The White House Medical Unit Implemented Prescribing Practices That Did Not Comply with the Code of Federal Regulations and DEA Policy
The White House Medical Unit providers’ prescribing practices did not comply with the Code of Federal Regulations and DEA policy. We reviewed White House Medical Unit guidance on prescribing practices, DEA requirements for written prescriptions, and White House Medical Unit prescriptions. DEA policy requires that prescriptions for controlled substances contain the patient’s full name and address, as well as the name, address, and DEA registration number of the prescribing practitioner. The DEA policy also states that practitioners serving in the U.S. military must state their Service branch on controlled substance prescriptions as well as their Service identification number instead of a DEA registration number.
We concluded that the White House Medical Unit’s internal policy for controlled substance prescriptions was insufficient to meet the DEA requirements for controlled substance prescriptions, omitting the requirements for patient address and practitioner address, branch of Service, and Service identification number. We requested examples of White House Medical Unit provider prescriptions, and White House Medical Unit officials provided us with 11 examples of controlled substance prescriptions. We concluded that none of the prescriptions met all the DEA requirements for written prescriptions nor did they meet the requirements of White House Medical Unit’s Controlled Substances Inventory and Management Policy.19 [WHMU SOP 20-08, “Controlled Substances Inventory and Management Policy,” August 30, 2019.] In particular, the provider’s full name, address, Service branch, and Service identification number were missing from the prescriptions we reviewed.
White House Medical Unit officials redacted all patient information on the prescription examples they provided, so we were unable to determine whether the prescriptions met the DEA’s patient‑specific information requirements. Figure 4 demonstrates three examples of prescriptions for controlled substances that are missing information required by the DEA. The first example is missing the date and patient’s address, the second example is missing all of the provider’s information except the signature, and the third example is missing the provider’s address and DEA or Service number.
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Figure 4. Samples of White House Medical Unit Controlled Substance Prescriptions Source: White House Medical Unit.
The White House Medical Unit Implemented Dispensing Practices That Did Not Comply with Service Guidance
We concluded that the White House Medical Unit dispensed non‑emergency controlled medications, such as Ambien and Provigil, without verifying the patient’s identity. The White House Medical Unit senior leaders stated that the White House Medical Unit provided pharmaceutical support for travelers on White House official travel. This included the dispensing of controlled substances, such as Ambien and Provigil. In our review of the White House Medical Unit’s controlled substance disposition forms, we concluded that the White House Medical Unit also dispensed Schedule II and Schedule III controlled substances, which were generally outside the scope of outpatient care.
At the EEOB and WHCA clinics, we observed several self‑service, open‑access containers offering a limited selection of common over‑the‑counter medications, such as Motrin, Pepto‑Bismol, or cough drops. Patients and staff at these clinics retrieve the over‑the‑counter (OTC) medications as needed, without cost and without being seen by a medical provider. However, the Navy Manual of the Medical Department expressly prohibits this practice.
Under no circumstances will a patient be authorized to select their own medications. A health care screener (Hospital Corpsman that has completed the sick call screener course or nurse) must either assess a patient’s symptoms, select the appropriate item(s) on the approved list, and send the list with the patient to the pharmacy, or refer the patient for more definitive care.20 [NAVMED P-117, “Manual of the Medical Department U.S. Navy”, Change 163, March 5, 2018.]
As part of this evaluation, we analyzed the transcripts of 70 DoD OIG AI team interviews with DoD staff assigned to the White House Military Office between 2009 and 2018. This evaluation incorporates direct quotes from the testimony of these witnesses. The DoD OIG AI team interviewed former White House Medical Unit medical staff members who had direct responsibility for dispensing prescription medications. Several of these former staff members expressed concerns about the White House Medical Unit’s policies and procedures pertaining to the distribution of prescription medications. The following are examples of the responses from these witnesses that illustrate that the White House Medical Unit’s medication dispensing practices did not comply with military guidance.
Witness #1: Anything that took place at the White House Clinic was never written down, never recorded. [However,] the only record that you ever had that a patient came in and got any sort of medication would have been if it was a controlled substance that we were required to document for the pharmacy. But if you came in and got any other prescription medication that wasn’t classified as a controlled substance there would be no record that you came in and did anything.
Witness #2: So, traditionally, we would ‑‑ as part of the duty there in the President’s clinic, we would go ahead and make prepacks of medications. . . . Well, before we would get ready for a big overseas trip, one of our requirements was to go ahead and make packets up for the controlled medications. And those would typically be Ambien or Provigil and typically both, right. So we would normally make these packets of Ambien and Provigil, and a lot of times they’d be in like five tablets in a zip‑lock bag. And so traditionally, too, we would hand these out. . . . But a lot of times the senior staff would come by or their staff representatives . . . would come by the residence clinic to pick it up. And it was very much a, hey, I’m here to pick this up for Ms. X. And the expectation was we just go ahead and pass it out.
Witness #3: Dr. [X] asked if I could hook up this person with some Provigil as a parting gift for leaving the White House. And at the time, the corpsmen and the medics, the enlisted corpsmen and the medics, it was okay for us to dispense Provigil and Ambien without having a provider present. I’m not sure if it was okay as far as, like, what’s medically allowed. But in the unit, it was authorized for us to do that kind of stuff.
