DEPARTMENT OF VETERANS AFFAIRS WASHINGTON DC 20420

The Honorable Carotyn N. Lerner Special Counsel U.S. Office of Special Counsel 1730 M Street, NW, Suite 300 Washington, DC 20036

RE: OSC File No. Dl-14-3310

Dear Ms. Lerner:

March 6, 2015

I am responding to your letter regarding allegations rnade by a whistleblower, Maurice Skillern, a physician assistant (hereafter, the whistleblower), at the Orthopedic Clinic at the Memphis Department of Veterans Affairs (VA) Medical Center, Memphis, Tennessee (hereafter the Medical Center). The whistleblower alleged that Medical Center management receives financial bonuses for limiting the number of non-VA referrals, thereby engaging in conduct that may constitute violations of laws, rules or regulations, and gross mismanagement, which may lead to a substantial and specific danger to public health. The Secretary has delegated to me the authority to sign the enclosed report and take any actions deemed necessary as referenced in 5 United States Code § 1213(d)(5).

The Secretary asked that the Interim Under Secretary for Health refer the whistleblower's allegations to the Office of the Medical Inspector, who assembled and led a VA team to investigate these allegations. The team cor:,ducted a site visit to the Medical Center on October 14-17, 2014. VA substantiated two of the four allegations but did not find actions that constituted a violation of laws, rules, regulations, gross mismanagement, or a danger to public health and safety.

VA made eight recommendations for the Medical Center. Findings from the investigation are contained in the report, which l am submitting for your review.

Thank you for the opportunity to respond.

Sincerely,

1 .C)~" #I'\(., l:J. ~ se D. Ri ja

hief of Staff

Enclosure

DEPARTMENT OF VETERANS AFFAIRS Washington, DC

Report to the

Office of Special Counsel

OSC File Number Dl-14-3310

Department of Veterans Affairs

Memphis Veterans Affairs Medical Center

Memphis, Tennessee

Report Date: February 12, 2015

TRIM 2014-D-1472

Executive Summary

At the request of the Secretary, the Interim Under Secretary for Health (USH) directed the Office of the Medical Inspector (OMI) to assemble and lead a team to investigate allegations lodged with the Office of Special Counsel (OSC) concerning the Orthopedic Clinic at the Memphis Department of Veterans Affairs (VA) Medical Center, Memphis, Tennessee (hereafter, the Medical Center) by Maurice Skillern, a physician assistant (hereafter the whistleblower), who consented to the disclosure of his name. The whistleblower alleged that Medical Center management receives financial bonuses for limiting the number of non-VA referrals, thereby engaging in conduct that may constitute violations of laws, rules or regulations, and gross mismanagement, which may lead to a substantial and specific danger to public health. The VA team conducted a site visit to the Medical Center on October 14-17, 2014.

Specific Allegations of the Whistleblower

1. Despite formerly sending patients needing full-joint replacement to private providers on a fee-basis, Memphis VAMC management has declined to do so since 2012.

2. The failure to send patients to private providers on a fee basis has resulted in a year-long wait for a joint replacement.

3. Patients waiting for joint replacement are frequently referred back to Primary Care where they are placed on prescription drugs for pain management.

4. The unnecessary extended wait time and referral back to Primary Care for these patients may have a negative effect on patients' health.

VA substantiated allegations when the facts and findings supported that the alleged events or actions took place and did not substantiate allegations when the facts and findings showed the allegations were unfounded. VA was not able to substantiate allegations when the available evidence was not sufficient to support conclusions about whether the alleged event or action took place with reasonable certainty.

After careful review of its investigative findings, VA made the following conclusions and recommendations.

Conclusions for Allegation 1

• VA did not substantiate the allegation that despite formerly sending patients needing total joint replacement to private providers on a fee basis (now referred to as "non-VA medical care"), the Medical Center management has declined to do so since 2012.

• The Medical Center has regularly used non-VA medical care to reduce its backlog of total joint replacements.

• The Medical Center is currently not staffed or supplied to provide the preoperative, intraoperative, and postoperative support for the operating room (OR) expansion.

Recommendations to the Medical Center

1. Continue to monitor patients in the queue for total joint replacements and manage appropriately.

2. Hire appropriate staff to support OR expansion and review OR scheduling to ensure that the maximum weekly number of total joint procedures can be performed.

3. Collaborate with Human Resources (HR), Workforce Development, and the University to hire orthopedic surgeons, nurses, and support staff to meet the needs of the expanded OR.

Conclusions for Allegation 2

• VA substantiated that in the past, there had been an 8-12 month waiting list for total joint replacements at the Medical Center; however, current wait times are 6-8 weeks.

• VA did not substantiate that the Medical Center failed to send patients for non-VA medical care.

• Appropriate use of the Electronic Wait List (EWL) will raise Medical Center leadership's awareness of wait times.

Recommendations for the Medical Center:

4. Reeducate and train the procedure schedulers for Orthopedics on utilizing the EWL to provide accurate data on wait times for patients cleared for surgery.

5. Improve clinical management oversight (Chief of Orthopedics, Chief of Surgery, and Deputy Chief of Staff (DCoS)) of the EWL for total joint replacements to continue to minimize wait times.

6. Make sure that patients are thoroughly informed of their options for total joint replacements, including any legally-available options to obtain the needed services through non-VA medical care contract providers, if wait times are greater than 30 days.

Conclusion for Allegation 3

• VA substantiated that patients waiting for total joint replacements are frequently referred to their primary care manager (PCM), where they are placed on prescription drugs for pain management. However, this multidisciplinary approach is a standard

practice, resulting in better overall pain management and control for individual patients.

Recommendation to the Medical Center

7. Continue offering "Pain Management Boot Camp" educational seminars or equivalent pain management training for new and current PCMs.

Conclusions for Allegation 4

• VA concluded that the Medical Center appropriately managed these Veterans' cases, addressing each patient's individual condition, treatment plan, and medically related issues.

• VA did not substantiate that unnecessary extended wait times and referrals back to PCMs for patients awaiting total joint replacement had a negative effect on their health.

Recommendation to the Medical Center

8. In accordance with VHA Directive 1005 on pain management, make sure that opioid contracts are in place for all appropriate Veterans who receive narcotics while awaiting total joint replacement

Summary Statement

OMI has developed this report in consultation with other VA and VHA offices to address OSC's concerns that the Medical Center may have violated law, rule or regulation, engaged in gross mismanagement, an abuse of authority, or risked public health or safety. In particular, the Office of General Counsel (OGC) has provided a legal review and the Office of Accountability Review (OAR) has examined the issues from an HR perspective, establishing individual accountability, when appropriate, for improper personnel practices. VA did not find any violations at the Medical Center.

Table of Contents

Executive Summary ...................................................................................................... ii

I. Introduction ............................................................................................................... 1

II. Facility Profile .......................................................................................................... 1

Ill. Specific Allegations of the Whistleblower ............................................................... 2

IV. Conduct of Investigation ......................................................................................... 2

V. Findings, Conclusions, and Recommendations ...................................................... 3

VI. Summary Statement ............................................................................................. 17

Attachment A. .............................................................................................................. 19

I. Introduction

At the request of the Secretary, the Interim USH directed OM! to assemble and lead a team to investigate allegations lodged with OSC concerning the Orthopedic Clinic at the Medical Center by the whistleblower, who alleged that Medical Center management receives financial bonuses for limiting the number of non~VA referrals, thereby engaging in conduct that may constitute violations of laws, rules or regulations, and gross mismanagement, which may lead to a substantial and specific danger to public health. The VA team conducted a site visit to the Medical Center on October 14-17, 2014.

II. Facility Profile

The Medical Center is a complexity level 1 a tertiary care facility consisting of one main campus with 243 inpatient beds, including a 60-bed Spinal Cord Injury Unit It maintains an average daily census of 133, and currently has a 68 percent occupancy rate; it had 891,965 outpatient visits and performed 3,279 surgical procedures during fiscal year (FY) 2014 as of June 30, 2014. 1 The Medical Center operates nine community-based outpatient clinics (CBOC) to bring services to more than 206,000 Veterans living ln 53 counties of Tennessee, Arkansas, and Mississippi. Three of the CB0Cs (Memphis North, Memphis South, and Memphis Jackson) are staffed by VA; the rest are contracted (Helena and Jonesboro, Arkansas; Byhalia and SmithvHle, Mississippi; and Dyersburg and Savannah, Tennessee). The Medical Center is part of the Veterans Integrated Service Network (VISN) 9.

As a teaching hospital providing a full range of patient care services, with state-of-the­art technology, as well as extensive education and research programs, the Medical Center offers comprehensive primary, secondary, and tertiary health care in rnedicine, general surgery, cardiovascular and neurological surgery, orihopedics, physical medicine and rehabilitation, spinal cord injury, neurology, oncology, psychiatry, dentistry. and geriatrics. Specialized outpatient services are provided through general, specialty, and subspecialty outpatient clinics, including a women's health center. The Medical Center is affiliated with the University of Tennessee Health Science Center, College of Medicine and with the University of Tennessee, School of Dentistry. The facility offers residency training in all major medical and surgical specialties and subspecialties, and trains medical students and dental residents annually, along with students from other schools completing clinical rotations in associated health fields.

1 Complexity level 1c: complexity levels are determined by patient population (volume and complexity of care}, complexity of clinical services offered, and education and research {number of residents, affiliated teaching programs, and research dollars). Complexity level 1 is the most complex and level 3 are the least comp!ex; complexity for level 2 facilities is considered moderate. {Veterans Health Administration Executive Decision Memo (EDM), 2011 Facility Complexity Level Model).

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Ill. Specific Allegations of the Whistleblower

1. Despite formerly sending patients need ing full-joint replacement to private providers on a fee basis, Memphis VAMC management has declined to do so since 2012.

2. The fa ilure to send patients to private providers on a fee basis has resulted in a yearlong wait for a joint replacement.

3. Patients waiting for joint replacement are frequently referred back to Primary Care where they are placed on prescription drugs for pain management.

4. The unnecessary extended wait time and referral back to Primary Care for these patients may have a negative effect on patients' health .

IV. Conduct of Investigation

The VA team visiting the Medical Center consisted of-·- · ......,..,--------,,-,--...,.,..,~-Deputy Medical Inspector (general surgeon); , Nurse Practitioner (NP), Clinical Program Manager, both from OMI; , V ISN 6 Business Implementation Manager; and Supervisory HR Specialist. VA reviewed relevant policies, procedures, professional standards, reports, memorandums, and other documents listed in Attachment A. We toured the OR, the inpatient ward for postoperative orthopedic patients, and the Orthopedic Clinic. We also held entrance and exit briefings with Medical Center leadership.

VA initially interviewed the whistleblower via teleconference on September 17, 2014, , Chief of Staff (CoS), on October 9, and , ,_ _________ ....

Former Chief of Purchased Care on October 21. We conducted a second off-site interview with the whistleblower on October 14.

We also interviewed the following Medical Center employees:

• • 0

• • 0

• • • 0

0

0

• • 0

• •

, Medical Center Director ;.:::;.:':iiiiiiii"=====;--:A~ssociate Director for Patient Care Services (ADPCS)

, Deputy Cos (DCoS) ==iiiiii======i"Assistant CoS (ACoS), Education Services

Interim ACoS, Ambulatory Care =:;;;;:====~. Chief, Surgical Services

Chief, Orthopedic Surgery ====~--,. Chief, Ambulatory Care

, OR Manager liiciii==iiiii=======i""'

, Patient Flow Coordinator =====.:... Orthopedic Nurse Liaison

==.:::;;;;;;:======;,-' Non-VA Care Consult Coordinator , Physician Assistant (PA), Orthopedic Clinic

=:;;;;:======i,, MD, Contract Orthopedic Surgeon , MD, Contract Orthopedic Surgeon

====:' , Patient Advocate ==-='iiiiiii'==='i""

, Chief, Business Office -----2

• • • • •

:, Chief, Purchased Care ~===.;, Former Chief, Purchased Care

,HR ~;.;:==,--;:A-,d:-m:-:-in".":"istrative Officer, Surgical Service c..::..=-=.. ___ _,1 , Chief, Logistics

V. Findings, Conclusions, and Recommendations

Background

The approved hierarchy for ordering care for Veterans is:

1. VA health care facilities; 2. Sharing Agreements with Department of Defense facilities or affiliated

universities; 3. Contracts; 4. Invoice-based non-VA facilities (related to certain reimbursement claims).

Veterans must be enrolled in the VA health care system as a condition for receiving the medical benefits package unless exempt from enrollment requirements and sti ll eligible for the package. See 38 C.F.R. § 17.36 and 17.37.2

Non-VA Medical Care

Generally speaking, VA establishes contracts for hospital care and medical services with non-VA facilities when it cannot furnish medical care because of lack of capability or geographic inaccessibility. In the absence of a sharing agreement entered under 38 U.S.C. § 8153, VA has limited contract authority to provide non-VA medical care and services to Veterans. See 38 U.S.C. 1703 and its implementing regulations at 38 C.F.R. §§17.52 and 17.53.

In addition, consistent with the start dates set forth in 38 C.F.R. § 17.1525, if a Veteran meets the eligibility criteria of section 101 of the Veterans Access, Choice, and Accountability Act of 2014, Pub. L. 113-146, as implemented by VA's interim fina l rule (codified at 38 C.F.R. §§ 17.1500 through 17.1540), then the Veteran may be eligible to elect to obtain needed care at VA expense from an elig ible entity or provider as defined in 38 C.F.R. § 17.1 530. Note that VA obtained this contract authority after the time­period at issue in this case.

Consultations for non-VA medical care must be entered and approved in the Veterans Health Information Systems and Technology Architecture (VistA) Computerized Patient Record System (CPRS) consult package and must comply with approved Non-VA Medical Care Coordination (NVCC) business processes. After the request is entered by

2 www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title38/38cfr17 _main.

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a provider at this Medical Center, it is authorized by the CoS's office and then goes to the purchased care office for processing.

Elective Surgery

An elective surgery is a planned , nonemergent surgical procedure, either medically indicated to remove or improve a disease process, or to address a cosmetic issue.3

Elective surgeries may extend life or improve the quality of life physically and/or psychologically. However, unlike emergency surgery (e.g., appendectomy), which must be performed immediately, an elective procedure can be scheduled at the convenience of both the patient and the surgeon .

Elective surgeries cover every system of the body; the most frequently performed are:

• Refractive: laser surgery for vision correction, • Gynecological: hysterectomies or tubal ligations, • Exploratory or diagnostic: to determine the origin and extent of a medical problem,

or to biopsy tissue samples, • Cardiovascular: improvements of blood flow or heart function, such as the

implantation of a pacemaker, and • Musculoskeletal: hip replacement or anterior cruciform ligament (ACL)

reconstruction .

In 2010, the Centers for Disease Control's National Hospital Discharge Survey reported U.S. surgeons performed more than one million total joint replacements, and the number of joint replacements is projected to increase, given our aging, increasingly active population.4

Allegation 1.

Despite formerly sending patients needing full-joint replacement to private providers on a fee basis, Memphis VAMC management has declined to do so since 2012.

Findings

VA interviewed a former Chief of Purchased Care who had served from June 2011 to August 2012. He stated that during his tenure the Medical Center never stopped providing non-VA medical care for total joint surgery; that the Director never made any decision declining non-VA medical care; that funding was always available; and that the facility has always been able to fund non-VA medical care at least at historical spending levels.

3 Encyclopedia of Surgery. Copyright © 2007-2014 Advameg, Inc. http://www.surgeryencyclopedia.com/ 4 Centers for Disease Control and Prevention , FastStats Home, May 14, 201 4:

http://www.cdc.gov/nch s/fastats/inpatient-su rgery . him

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The Chief of Orthopedic Surgery told VA that 3 or 4 years ago he referred a few patients to a non-VA Hospital in Jackson, Tennessee, but each of the patients treated there had negative surgical outcomes. They developed knee infections and had to be brought back to the Medical Center for revisions.5 The Medical Center has a long-standing agreement with its affiliate, the University of Tennessee, and its orthopedic group the Campbell Clinic, to provide VA with one full-time employee equivalent (FTEE) or 131,2 hours of surgical services per month, The Campbell Clinic also manages the orthopedic surgery residency program. Because of the contract with the Campbell Clinic's orthopedic surgeons and the history of bad outcomes with non-VA care, the Chief of Orthopedics was reluctant to refer patients out of the Medical Center, and although rt required a wait for surgery, he thought Veterans would have the best surgeons in the area operating on them at the Medical Center and experience better clinical outcomes. Consistent with outpatient scheduling policy and scheduling priority regulation, 38 C.F.R. 17.49, he indicated that priority for scheduling in-house elective surgery always went to service-connected Veterans, although Veterans with emergency fractures would move ahead of them on the list If patients did not want to wait more than 30 days for elective care at VA, and were eHgible for non-VA medical care, they would be referred as discussed above. He also stated that starting in 2012; the Medical Center encouraged the use of non-VA medical care to reduce patient wait times.

Staff members confirmed that in 2012 and 2013, the Orthopedic Ctinic had at any given time, between 40 and 70 patients being evaluated for total joint replacement However, they were not placed in the VistA software package until they came in for their pre­operative workup within 30 days of their surgical date. At that time they would appear on the EWL.6 The number of patients waiting for this surgery, coupled with the influx of new patients, resulted in an average wait time of 8-12 months for total joint replacements. Orthopedic surgeons and staff told VA that a number of Veterans appeared to be waiting for extended periods of time, when often they had not yet been medically cleared for surgery. For example, surgeons cannot operate safely on Veterans who have failed to lose the recommended amount of weight, or on patients with diabetes who are unable to achieve and maintain a hemoglobin A1C of !ess than seven. 7 The Orthopedic Nurse Liaison reiterated that Veterans are on the pending list for a variety of reasons, including medical and dental clearances; however, it was evident to us that she was not entirely familiar with the appropriate use of the EWL She was unable to answer basic questions about how to navigate the system, although she ctaimed to have recently received training on its use. A review of a hand-written

5 Reasons for revising a joint replacement include worn-out implants, infection of a replaced joint, and instability or malpositioning of an implanted joint. Revision Joint Replacement, Cluett J., January 1, 2014. http://orthopedics.about.com/cs/joi n trep!acement1 lg/revision. htm.

6 Electronic Walt List -A VistA software package designed for recording, tracking and reporting veterans unable to acquire appropriate appointments within a specific VA medical center. The EWL may be used as a tool to avoid pre-scheduling clinics until the appropriate retum interval, for example to track return appointment times for Advanced Clinic Access. VisfA e Electronic Wait List (EWL) for Scheduling and Primary Care Management

- Modufe (PCMM) User Manual, November 2002 (Revised July 2012}, ' The A 1 C test is a common bfood test used to diagnose type 1 and type 2 diabetes and to gauge how well a person

is managing diabetes. The higher the A 1 C level, the poorer the blood sugar control and thus the greater the risk of diabetes complications, Tests and Procedures: A1C test, Mayo Clinic Staff.© 1998-2014 Mayo Foundation for Medicai Education and Research, http://www,mayoclinic.org/tests-procedures/a1c-test/basics/definition/prc-20012585,

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scheduling book on her desk revealed patients projected out at least 2 months with workups pending.

In July 2013, VHA appointed the current Medical Center Director. She raised questions about orthopedic patient data and met with the Orthopedic Nurse Liaison to review the number of patients waiting for total joint replacements. After determining that Veterans were facing an 8-12 month wait for this surgery, she directed the staff to increase the number of referrals for non-VA medical care, as appropriate. The VISN furnished the Medical Center with additional funds, which it used to provide more non-VA medical care. The Director could not recall any time in her tenure when funding was not available for non-VA medical care for total joint replacements.

The Medical Center's Chief, Business Office told VA that once leadership became aware of the backlog of patients seeking total joint replacements, they requested additional funding through the VISN, and quickly received $3 million to pay for these procedures and the associated care, averaging approximately $45,000 per case. In the fall of 2013, the Chief of Purchased Care identified several local eligible orthopedic surgery groups with which the Medical Center could contract, but only one would accept VA's rate of payment. Upon agreement, consults were approved and patients were scheduled with providers from that practice. Shortly thereafter, the Medical Center became aware of a concern with one of the providers in the group. The issues with this provider were highlighted in the local papers. This publicity resulted in the DCoS discussing the issue with Regional Counsel. Together, they concluded that the Medical Center could not refer patients to this provider. This initial setback did slow, but did not stop, the efforts to eliminate the backlog. Following the Director's 2013 decision, physicians requested non-VA medical care for 70 total joint replacements and all requested consults were approved.

In 2014, with additional funds available from VA's Access to Care Initiative (ACI) the Medical Center Director had staff actively contact Veterans to ask them if they would receive their total joint replacement from an outside provider. If the Veteran agreed, the Medical Center generated a consult to provide this care. The Medical Center provided those Veterans who still wished to have their surgery at VA a firm date for their procedure. In FY 2014, the Medical Center requested and approved 100 total joint cases for referral to non-VA care. This campaign eliminated the backlog at that time. During the site visit, VA's review of the EWL confirmed that only one patient was awaiting surgery (at the patient's request) for January 2015.

The nurse who tracks consults for non-VA medical care told us that at no time during her tenure had the facility denied non-VA medical care.

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The Medical Center manages 4 ORs and is undergoing renovations to expand to 1 O ORs. This project began in June 2012, and is due to be completed by December 2015. By the end of January 2015, the Medical Center will have completed the next phase of its renovations and 7 ORs will be available. At the time of this investigation, orthopedic surgeons average two total joint replacements per week; when the OR is expanded to full capacity, they will be able to complete four or more per week.

Conclusions

• VA did not substantiate the allegation that despite formerly sending patients needing total joint replacement to private providers for non-VA medical care, the Medical Center management has declined to do so since 2012.

• The Medical Center has regularly used non-VA medical care to reduce its backlog of total joint replacements.

• The Medical Center is currently not staffed or supplied to provide the preoperative, intraoperative, and postoperative support for the OR expansion.

Recommendations to the Medical Center

1. Continue to monitor patients in the queue for total joint replacement and manage appropriately.

2. Hire appropriate staff to support OR expansion and review OR scheduling to ensure that the maximum weekly number of total joint procedures can be performed.

3. Collaborate with HR, Workforce Development, and the University to hire orthopedic surgeons, nurses, and support staff to meet the needs of the expanded OR

Allegation 2.

The failure to send patients to private providers on a fee basis has resulted in a yearlong wait for a joint replacement.

Findings

See findings in allegation 1 for additional details. Veterans at the Medical Center had experienced wait times up to 1 year for total joint replacement; however, during 2012-2014, the time period in question, the Medical Center never stopped sending patients out for non-VA medical care.

Also, as noted above, the Orthopedic Nurse Liaison case managed patients undergoing preoperative evaluations to ensure they were ready for surgical implant procedures; however, she did not place them in the VistA Surgical Package after clearance was completed, but rather waited until they were scheduled for their preoperative

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appointment, which was within 30 days of their surgery. For accurate data on wait times, patients should be placed in the VistA after all required evaluations and clearance for surgery is completed, and the patient has selected a date for an operation.

While the whistleblower alleged that the waiting time for a community provider to perform a total joint replacement was 4 weeks, he was unable to provide an example of a patient experiencing this quick turnaround, nor could he provide the name of a community provider who met this timeframe. According to the Chief of Orthopedics, the current waiting time for primary orthopedic surgery in the Memphis community is 6-8 weeks. One of the Campbell Clinic surgeons reported his private practice wait time was 8-12 weeks. In the Medical Center, patients are currently scheduled 6 weeks in advance for primary orthopedic procedures and 8-12 weeks for revision surgery; the Medical Center has one orthopedic surgeon who does revisions. Veterans are made aware of the wait times for surgery at the Medical Center, and if eligible, have the option of receiving non-VA medical care. The Medical Center can currently accommodate the patient's requested date of surgery.

The whistleblower alleged that management received performance bonuses for not utilizing non-VA medical care; he did not, however, provide specific evidence to support his allegation. We reviewed the performance documents from FYs 2012, 2013, and 2014, pertaining to all management officials involved with non-VA medical care approval, and found none containing performance measures that would reward a decrease in non-VA medical care. We found measures in the performance plans of the DCoS and the ACoS/E mandating their assistance in the review of non-VA medical care requests; however, these measures contained nothing regarding either the number of requests they must review or numbers or percentages they must approve or disapprove, and they contained no mention of maintenance or adherence to a budget. In addition, we interviewed no one who was aware of any performance bonuses linked to limiting non-VA medical care.

Conclusions

• VA substantiated that in the past, there had been an 8-12 month waiting list for total joint replacements at the Medical Center; however, current wait times are 6-8 weeks.

• VA did not substantiate that the Medical Center failed to send patients for non-VA medical care.

• Appropriate use of the EWL will raise Medical Center leadership's awareness of wait times.

Recommendations to the Medical Center:

4. Reeducate and train the procedure schedulers for Orthopedics on utilizing the EWL to provide accurate data on wait times for patients cleared for surgery.

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5. Improve clinical management oversight (Chief of Orthopedics, Chief of Surgery, and DCoS) of the EWL for total joint replacements to continue to minimize wait times.

6, Make sure that patients are thoroughly informed of their options for total joint replacements, including any !egallywavailable options to obtain the needed services through non-VA medical care contract providers, if wait times are greater than 30 days.

VII. Allegation 3

Patients waiting for joint replacement are frequently referred back to Primary Care where they are placed on prescription drugs for pain management

Findings

Medical Center leadership said that they had adopted a two-pronged approach to managing orthopedic patients:

• The Orthopedic staff follows patients who are awaiting surgery and require surgical clearances; these providers typically prescribe nonsteroidal anti-inflammatory drugs, and also provide steroid injections for pain relief, instructing patients to follow up with their PCM for other modalities of treatment or stronger pain relief. The Chief of Orthopedics instructs hls staff not to prescribe any narcotics for patients other than those immediately postsurgical: any refills must be written by the patient's PCM.

a The Orthopedic staff refers all patients needing pain management to PCMs. Both the Interim ACoS for Ambulatory Care and the Chief of Ambulatory Care stated that orthopedics follows this practice to ensure that patients awaiting surgery are receiving coordinated care. Non-cancer patients requiring narcotics for more than 90 days are placed on opioid contracts and are closely monitored by their PCMs.8

PCMs routinely perform chart reviews and evaluate whether they can offer patients alternative treatments to alleviate pain. In their pain management plans, PC Ms also make referrals, as appropriate, into the community, using non-VA medical care funding for chiropractic, acupuncture, and aqua therapy,

VA found that the Medical Center does not have a pain management clinic; however, during our site visit an educatlonal seminar, "Pain Management Boot Camp," was underway for the PCMs, and the facility had already scheduled another one for October 22, 2014. The seminars employed a multidisciplinary approach involving pharmacy, physical therapy, mental health, health promotion, and disease prevention.

8 VHA Directive 1005, Informed Consent For Long-Term Opiod Therapy For Pain, May 6, 2014

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Conclusion

• VA substantiated that patients waiting for total joint replacements are frequently referred to PC, where they are placed on prescription drugs for pain management. However, this multidisciplinary approach is a standard practice, resulting in better overall pain management and control for individual patients.

Recommendation to the Medical Center

7. Continue "Pain Management Boot Camp" educational seminars or equivalent pain management training for new and current Primary care providers.

Al legation 4

The unnecessary extended wait time and referral back to Primary Care for these patients may have a negative effect on patients' health.

Findings

Wait times for elective procedures can vary. First, the orthopedic surgeon must decide whether the patient is a candidate for the orthopedic procedure, and if so, the surgeon will write orders for the Orthopedic Nurse Liaison to coordinate a pre-operational work­up. Certain factors - such as age, cardiac conditions, dental screening, immune system disorders or infection, pulmonary conditions (including smoking), obesity, liver functions, and diabetes - can extend the length of time a patient must wait for surgery.9 Before elective surgery can proceed, PCMs optimize patients' medical conditions.

Clinical Care

VA reviewed the medical records of 16 Veterans who had lodged complaints with the patient advocate concerning orthopedic wait times for total joint replacements to assess whether any of them had experienced negative health effects as a result of waiting for surgery.

Veteran 1

Veteran 1 is an male being followed by orthopedics for bilateral knee pain. An orthopedic PA and orthopedic surgery resident initially evaluated him on .,_,,,_ _ __. 2012. They managed him conservatively with injections, anti-inflammatory medications, and assistive devices (walker) and placed him on the wait list. On he saw his PCM and discussed the surgery and whether he wanted to wait or go to an outside facility. He was seen again in orthopedics on

by the attending surgeon and informed that the wait list was 8-12 ___ ......... months. The attending surgeon told him to speak with the orthopedic PA and his

9 Preoperative Risk Stratification and Risk Reduction for Total Joint Reconstruction. Ng, V.Y., Lustenberger, D., Hoang, K., et al, The Journal of Bone and Joint Surgery. 2013 ;95:e19 (1-15).

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PCM about arthritic pain medication, and said that he would be contacted for a surgery date. PCM and orthopedics continued to follow him for his joint pain, and urology, physical therapy, and audiology continued to follow him as well. Orthopedics called him on 2013, and scheduled him for surgery on

. The service cancelled the operation due to a "heavy caseload." On ,___...., Veteran had a total left knee arthroplasty; the surgery was uneventful, and they discharged the patient on . He is reportedly doing well 1 year postsurgery. The Veteran received postoperative pain management of Oxycodone (5/325 acetaminophen) upon discharge and again on and ------2013, with an increased dosage (5/500). He has not received any additional opioid analgesics.

Veteran 2

Veteran 2 is a male evaluated by his PCM on 2012, and given a prescription for Oxycodone and an appointment to the Orthopedic Clinic. On that date, the orthopedic PA evaluated him and recommended that he follow up in orthopedics for a total hip replacement consultation. The orthopedic attending physician evaluated him on and on the Orthopedic Nurse Liaison scheduled his surgery for On , the Veteran received in injection in the right hip for pain relief, and surgery was delayed due to the injection. On the Veteran underwent a left total hip arthroscopy. He was discharged with pain medication (Oxycodone) on ___ .... 2013. On 2013, he was admitted to the Medical Center for right total hip arthroplasty. Upon discharge, he received pain medication and reportedly has not had any opioid analgesics since.

Veteran 3

Veteran 3 is a male with a history of multiple medical problems, including polysubstance abuse, and a previous history of a right total knee replacement in 2010. Orthopedics evaluated him on , 2012, and again on 2012, for right knee follow-up, and he was doing well with regards to his knee. His PCM evaluated him for back pain on , 2012, and the Veteran signed a pain management contract. The Veteran was under the care of PC, physical therapy, psychology, neurosurgery, kinesiotherapy, and optometry. On 2013, neurosurgery's evaluation for back pain resulted in a referral to orthopedics for evaluation of his right hipt as they felt this was contributing to his back pain. It is common with orthopedic injuries that changes in body mechanics result in problems with other joints. Orthopedics evaluated him on ______ ___, , 2012, for his right hip pain and diagnosed avascular necrosis of the joint with collapse and scheduled him for an elective right total hip arthroplasty on 2013. Preoperatively he was evaluated by physical therapy, psychiatry, nursing, and his PCM in prepara,ion for his elective procedure. They were arranging nursing home care, which required a 3 day hospitalization prior to acceptance; however, on , 2012, the Veteran reported experiencing

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severe pain in his hip and an inability to get out of bed, he was instructed to call emergency services. Upon presentation to the Medical Center, the Emergency Department (ED) diagnosed him with an acute right hip fracture. He underwent an emergent right total hip arthroplasty on , 2012, and was discharged on

', 2012, to a skilled nursing facility to continue rehabilitation. He ......_........., __ -!

continues to be followed by orthopedics, neurosurgery, his PCM, and psychology.

Veteran 4

Veteran 4 is male who presented to the ED on 2012, for left hip pain. His PCM evaluated him on 2012. The patient had an MRI on and subsequently the PCM informed him via telephone he had ordered a consult to orthopedics. On the orthopedic attending surgeon evaluated him and offered surgery as an option, but with a wait of approximately 12 months. The Veteran said he was willing to wait. The note stated that the Veteran would be contacted as his surgery date approached and that he should inform the clinic staff if any problems occurred prior to surgery. On , 2013, orthopedics scheduled the patient for surgery on _..__, 2013; however, on orthopedics rescheduled the surgery to , pending cardiac clearance post cardiac catheterization on 2013. The orthopedic surgeon's pre-op note on indicated that the patient had a urinary tract infection and needed to be cleared by Urology; his surgery was rescheduled for

Per notes on , 2013, "Due to staff inavailability we have rescheduled his Stryker left total hip to /13 per ." On that date, the surgery went as planned. On IIJ 2014, the Veteran requested a refill on pain medications and was informed that he did not qualify for narcotic pain medication because he had tested positive for cannabinoids on

, 2013. In a 2014, note the PCM wrote, "While treating .__,,,,_-,.,---,, patient's post-operative pain we were ignoring his multiple +UDS's (urinary drug screens) for illicit drug (cannabinoids). Now for patient to possibly continue receiving narcotic pain medication as a "chronic pain patient, we must return to the rules and regulations of the VA Pain Management Agreement." The PCM offered the Veteran a consult to addiction therapy, but he has not been evaluated by the service.

Veteran 5

male with a history of left knee pain. His PCM initially .....,,,-,,-...,,....... saw him on 2012, and consulted to orthopedics. He saw the orthopedic PA on and received a corticosteroid injection into the knee. The PA managed him conservatively. Physical Therapy and the Sleep Clinic were following the Veteran. On , 2013, the orthopedic surgeon evaluated and scheduled surgery fo He underwent a left total knee replacement and was discharged on . He went to a rehabilitation center upon discharge and has since been followed by urology, psychology, vascular surgery, orthopedics, and primary care.

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Veteran 6

Veteran 6 is an male with a history of bilateral knee pain. Orthopedics has been following him since 2011 , and he had been receiving injections bilaterally. The pain in the right knee was greater than in the left. On 2013, the orthopedic surgeon evaluated him and placed him on the surgical work-up list. On

---- the Veteran called the Orthopedic Nurse Liaison; he informed her that he will seek care at Campbell Clinic. On the Orthopedic Nurse Liaison called the Veteran to follow up. He told her that the Campbell Clinic surgeon had informed him that he was not a surgical candidate due to poor circu lation. On

---,-.,--!' his PCM referred him back to orthopedics , where he has since been

receiving injections of Synvisc® in both knees, with the last injection on 2014.10 ----

Veteran 7

Veteran 7 is a male who presented to the ED on , 2013, complaining of 8 months of progressively sharper pain in his right hip. An orthopedic PA evaluated him on and referred him to the orthopedic surgeon, who evaluated him on and placed him on the surgical workup list. On 2013, an orthopedic surgeon informed him that there was still a significant wait, and that he would be "given a call when his time comes up for his surgery." On 2014, the Veteran followed up with orthopedics and was noted that his surgical date would not be until "at least ." He was told to speak with the Patient Advocate to possibly have his care done outside VA. On

, 2014, he had a total right hip replacement at the Medical Center and was .....,..__,_ .... discharged on with prescription pain medications. Through the Prescription Drug Monitoring Program, Pharmacy noted that the Veteran had received contro lled substances from an outside VA provider. The pharmacist recommended a pain management contract if the patient should request additional pain medications from VA.

Veteran 8

Veteran 8 is a male with a history of chronic right hip pain. An orthopedic surgeon initially evaluated him on 2012, and informed him that joint replacement is an elective procedure, and that he should go forward with the procedure only if "he decides his symptoms negate the risks of surgery." On ,__ .... 2013, the attending orthopedic surgeon noted that "both the receptionist and nurse tried to talk with this man to schedule surgery. He was pleasant to me but rude and cursing at them (the receptionist and nurse). This behavior is not acceptable and our staff will not have to put up with his abuse. I will not put him on the schedule." On 2013, the patient called the clinic and requested to see

10 Synvisc® is indicated for the treatment of pain in osteoarthritis of the knee. It is an injection that supplements the fluid in the knee to help lubricate and cushion the joint, and can provide up to six months of osteoarthritis knee pain rel ief. http://www.synviscone.com/

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a particular surgeon; he was given an appointment with that surgeon for ----was seen on that date, and then scheduled for 2014, for a total right hip replacement. The surgery proceeded as scheduled, and the Veteran was discharged 2014. Since then, he has been followed by his PCM and orthopedics and is reportedly doing well. Prior to surgery, he received intermittent doses of narcotic pain medications, ranging from 30-60 pills every 2 to 4 months. Postoperatively, he received one prescription of pain medication and has not requested any refills.

Veteran 9

Veteran 9 is a male who underwent a right tota l knee arthroplasty on

---,,----. 2012, after which he was followed by orthopedics, physical therapy, and dermatology. He continued to make progress postoperatively according to the surgeon. The Veteran told the surgeon on that he felt pain in the knee and that it felt tight. The surgeon manually manipulated the knee to increase its range of motion. Orthopedics continued to follow the Veteran intermittently and instructed him to follow up at the 1-year mark for repeat x-rays. He received pain medication intermittently for pain relief. On 2013, the Chief of Orthopedics evaluated him and referred the Veteran to see the orthopedic surgeon for a left total knee replacement.

On 2013, the patient kept his appointment with the orthopedic surgeon, who noticed swelling in the right knee and requested bloodwork. On

, the Veteran was reevaluated and placed on the wait list for a left total ----,--knee replacement, with a possible revision of the right knee. On he followed up and was given a corticosteroid injection into the left knee and informed to follow up in 3 months or sooner if needed. When the Veteran returned on

he still had pain and difficulty ambulating. The surgeon recommended -----,-...... conservative treatment, and this time the Veteran asked to return to the clinic for another injection prior to a trip he was planning in 2014. On he received an injection for the left knee pain. His surgery was scheduled for

....,.._ ... 2014, pending lab work, but the operation was postponed due to an elevated Hemoglobin A1C of 7.6. On , his A1C was 6.6, and surgery was rescheduled for Surgery proceeded as scheduled , and the patient was discharged on

He continued to be followed by orthopedics, physical therapy, dermatology, psychology, and pharmacy. On the Veteran underwent left knee manipulation under anesthesia, and followed up with orthopedics on

Subsequently, pharmacy noted that the Veteran was to complete a pain management contract in order to continue receiving narcotic pain medication. His pain management contract was signed 2014.

Veteran 10

Veteran 10 is a male with right hip pain since 2011. At that time, the PCM noted that he was taking over-the-counter medications that effectively

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alleviated his pain. Physical therapy evaluated and educated him on his diagnoses. They provided exercises to increase strength, and informed him to follow up as needed. On , he followed up with his PCM, who obtained x-rays and referred him to orthopedics. Orthopedics evaluated him on and informed him that the best treatment option was left total hip replacement surgery. On 2013, his orthopedic surgeon urged him to discontinue smoking (one-half pack a day habit). Dental cleared the Veteran on , 2014, and he called orthopedics several times without success to schedule his surgery. Orthopedics performed his surgery on , and discharged him on ,ii,eoa-_.--, He has not used any narcotic pain medication since 2014, and has stated that he is doing well.

Veteran 11

Veteran 11 is a male seen in the ED on 2013, and referred to ambulatory surgery for a suspected hernia. A general surgeon evaluated him and referred him to orthoped ics for right hip pain. On 2014, the orthopedic PA evaluated him and recommended follow up with the orthoped ic surgeon within 3 weeks for possible right hip replacement. The surgeon evaluated him on

. and scheduled a preoperative evaluation. He underwent surgery on , and was discharged on . The Medical Center provided narcotic .__,,___.

pain medication postoperatively in 201 3, and 2014. The Veteran states he is doing well and continues to follow up with orthopedics, hematology/oncology, and internal medicine.

Veteran 12

Veteran 12 is a male with a history of diabetes, right total knee replacement (2006), and left knee pain. On 2013, his PCM evaluated him and consulted orthopedics. On . the orthopedic PA evaluated him and informed him that he would need a left total knee replacement. He provided a corticosteroid injection for left knee pain . On 2013, he saw the orthopedic surgeon, who recommended knee replacement. Orthopedics discussed their waiting time, and the Veteran said he was will ing to wait. While waiting, the patient was followed by dermatology, psychology, and his PCM. On , his PCM noted he had a hemoglobin A 1C of 7.9; and in 2013, it was 7.7. The PCM counseled the Veteran to "follow diet/activity regimen better." He also instructed him to follow up in 5-6 months with repeat laboratory tests prior to his appointment. On

2014, the Orthopedic Nurse Liaison scheduled the patient for surgery on (IIJ On the Veteran followed up with PC and his A1C was 8.2. The PCM

counseled the patient about weight reduction and dietary restrictions, as well as about regular exercise at least 4 days a week. The provider also increased his oral medications and insulin injections, informing him of the goal of reaching an A 1 C less than 7.0. On the surgeon informed the Veteran that he would be rescheduled once his diabetes was under control in order to avoid surgical complications.

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Veteran 13

Veteran 13 is a -male who has been followed by orthopedics since 2008 for bilateral knee pain. Orthopedics initially discussed surgery; however noted he required dental clearance. On 2010, he had a total right knee replacement. On 2011 , he had a total left knee replacement. He continued to follow up with his PCM, gastroenterology, optometry, and orthopedics. On 2013, orthopedics reevaluated him to discuss a possible revision on his left knee "whenever the Veteran was ready. " The surgeon agreed to follow up with the Veteran every 6 months, or sooner, if he was having any difficulties. On orthopedics again saw the Veteran and scheduled him for surgery on , for a left total knee revision. On the surgery proceeded as planned , and the Veteran was discharged on lll) . He continued to be followed by orthopedics, physical medicine, physical therapy, and his PCM. He was also evaluated and followed for chronic lower back pain. On . 2014, he had a spine injection evaluation by physical medicine and was informed that he needed to be referred for non-VA Care. He understood the plan and verbally agreed. On the Veteran signed a pain management agreement, and on February 24 received a nerve block from an outside provider. On , he was evaluated by neurosurgery and was informed that he was not a surgical candidate. On , 2014, he was seen by an orthopedic surgeon, and at the Veteran's request, a consult was ordered for non-VA Care.

Veteran 14

male who underwent a left total hip replacement on On , orthopedics evaluated him for follow up and

left knee pain. They referred him to physical therapy and informed him to follow with orthopedics in 2 months. In 2013, he received a corticosteroid injection into the left knee for pain relief. He was then followed by his PCM, sleep clinic, recreation therapy, optometry, social work services, urology, and dental. On

2013, orthopedics re-evaluated him, and the surgeon made a clinical _ __,_,__..,...,... decision not to place him on the wait list for a total right hip replacement based on the Veterans' x-rays revealing mild to moderate arthritis. On , 2014, the orthopedic PA provided a left knee corticosteroid injection. On he requested and received another injection. His last visit with orthopedics was

', when he requested a consult to podiatry. No appointment has yet been ----scheduled.

Veteran 15

Veteran 15, a male with a long-standing history of bilateral knee pain, has been seen in orthopedics since 2009. In 2012, the orthopedic surgeon recommended that the patient be seen by a dentist for clearance due to his long-standing history of dental issues prior to placing him on the wait list for a right knee replacement. Dental evaluated him on and recommended additional

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dental work. He said that he would go to a private dentist to have the work completed . He was seen by his PCM in the interim. The Orthopedic Nurse Liaison contacted him several times, as did the dental staff, on , 2013, respectively. Dental cleared the Veteran on His orthopedic surgeon evaluated him on and scheduled surgery for His surgical date was moved up t , when he underwent a right total knee replacement. The patient reportedly is continuing to follow up with orthopedics and his PCM, as needed, and is relatively pain free. The Veteran did receive narcotic pain medications in · 2013.

Veteran 16

--- male, has been seen in orthopedics intermittently since --... 2013, the orthopedic PA evaluated him for bilateral knee pain and

administered a corticosteroid injection in both knees. On ., the orthopedic surgeon evaluated him and discussed the Veteran's surgical options and informed him that he would be placed on the wait list due to a 9-month backlog. The surgeon also told the Veteran to discuss his options with the patient advocate for non-VA Care. The Veteran saw his PCM and was given a consult for non-VA Care (orthopedic surgical care) on The Veteran underwent left total knee surgery on 2014, and was discharged on He reportedly continues to be followed up as needed by his PCM and non-VA Care.

Conclusions

• VA concluded that the Medical Center appropriately managed these Veterans' cases, addressing each patient's individual condition, treatment plan, and medically related issues.

• VA did not substantiate that unnecessary extended wait times and referrals back to PCMs for patients awaiting tota l joint replacement had a negative effect on their health.

Recommendation to the Medical Center

8. In accordance with VHA Directive 1005 on pain management, make sure that opioid contracts are in place for all appropriate Veterans who receive narcotics while awaiting total joint replacement.

VI. Summary Statement

OMI has developed this report in consultation with other VA and VHA offices to address OSC's concerns that the Medical Center may have violated law, rule or regulation, engaged in gross mismanagement, an abuse of authority, or risked public health or safety. In particular, the OGG has provided a legal review and the OAR has examined the issues from an HR perspective, in order to establish ind ividual accountability, when

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appropriate, for any improper personnel practices. VA did not find any violations at the Medical Center.

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Attachment A

Documents in addition to the Electronic Medical Records reviewed.

Memphis VAMC Bulletin, Authorization for Non-VA Medical Care, Number 2014-023, March 17, 2014.

Memphis VAMC, Chief of Staff Memorandum, Delegation of Clinical Approving Authorities, June 19, 2014.

Memphis VAMC, Business Planning Contract Fiscal Year (FY) 2014, Medicine Service, August 7, 2013.

Memphis VAMC. Non-VA Care Under VA Auspices, Policy Memorandum, 136-29, April 8, 2013.

Memphis VAMC, Non-VA Care Orthopedics Surgical Consults, FY 2011 -2014.

Memphis VAMC, OR Renovation Timeline, October 2014.

Memphis VAMC, Operating Room Schedule, July-August 2014.

Memphis VAMC, Operating Room Efficiency Reporls, FY 2012 2014.

Memphis VAMC, Orthopedic Authorization Report, FY 2012 - 2014.

Memphis VAMC, Orthopedic Surgery Consults, Fee Basis, FY 2012 -2014.

Memphis VAMC, Orthopedic Cancellations, FY 2014.

Memphis VAMC, Orthopedics Work-up List, FY 2014.

Memphis VAMC, Pain Management Boot Camp for Primary Care Providers, October 15, 2014.

Memphis VAMC, Patient Advocate Tracking System, Orthopedic Complaints, October 2012 - September 2014.

Memphis VAMC, Service Policy Memorandum, Daily Case Scheduling, Number 212/112/118-01, July 22, 2013.

Memphis VAMC, Service Policy Memorandum, Add On After Hour Case Scheduling and Classification, Number 212/112/118-02, July 22, 2013.

Memphis VAMC, Total Orthopedic Surgical Cases, FY 2012- 2014.

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VHA Directive1601, Non-VA Medical Care Program, January 23, 2013.

VHA Surgical Complexity listing of all VHA Facilities https://vaww.nso1.med.va.gov/vasgip/DUSHOMembeddedPages/complexity.aspx

VHA Directive 1005, Informed Consent For Long-Term Opiod Therapy For Pain, May 6, 2014

VHA Directive 2009-053, Pain Management, October 28, 2009

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