January 30, 2017 The Honorable Carolyn Lerner 1730 … FIle DI-14... · supplemental report....

DEPARTMENT OF VETERANS AFFAIRS Washington DC 20420

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

January 30, 2017

RE: OSC File No. D1-14-3637

Dear Ms. Lerner:

I am responding to your April 15, 2016, letter to the Department of Veterans Affairs (VA), Veterans Health Administration , National Transplant Program, National Surgery Office, Washington, DC regarding allegations made by a whistleblower at the -South Texas Veterans Health Care System (San Antonio VA Medical Center) , San Antonio, Texas, regarding the VA organ transplantation program, in general , and issues with that program at the Michael E. DeBakey VA Medical Center, Houston, Texas. The whistleblower made five allegations about the program that may constitute violations of law, 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 Under Secretary for Health directed the Office of the Medical Inspector to assemble and lead a VA team to conduct an investigation. The report substantiates one of the allegations, does not substantiate three others, and defers conclusions on the remaining one, pending an ongoing physician review of patient health records. VA makes three recommendations to the Medical Center and two to the Veterans Health Administration.

Thank you for the opportunity to respond .

Enclosure

Sincerely,

Gina S. Farrisee Acting Chief of Staff

DEPARTMENT OF VETERANS AFFAIRS Washington, DC

Report to the

Office of Special Counsel

OSC File Number Dl-14-3637

Department of Veterans Affairs (VA)

Veterans Health Administration

National Transplant Program/National Surgery Office

San Antonio and Houston, Texas

Report Date: January 23, 2017

TRIM 2016-D-2564

Executive Summary

The Under Secretary for Health directed the Office of the Medical Inspector {OMI) to assemble and lead a Department of Veterans Affairs {VA) team to investigate allegations lodged with the Office of Special Counsel {OSC) concerning the Veterans Health Administration {VHA), National Transplant Program, administered by the National Surgery Office {NSO), in Washington, DC, and concerning VA Transplant Centers {VATC) located throughout the country. The whistleblower alleged that employees who provide transplantation care are 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 Michael E. DeBakey VA Medical Center, Houston, Texas {Houston Medical Center) on June 6 and 7, 2016, and to the South Texas Veterans Health Care System, San Antonio, Texas {San Antonio Medical Center) on June 8 and 9, 2016.

In addition to reviewing policies and procedures and interviewing relevant staff members, we also initiated a peer review of the medical records of Veterans who have either undergone the transplantation of a kidney or a liver at a VATC or have been referred for that procedure. We wished to determine whether the standard of care had been met and whether that care had been delivered in a timely manner. We also want to know whether the eligibility criteria VA providers use to evaluate transplantation candidates is consistent with national eligibility criteria. The independent physician reviewers are at work on this project at present; their results will appear in a supplemental report. This report summarizes the findings, conclusions, and recommendations of the VA investigation.

Allegations

The whistleblower alleged that:

1. Communication between referring and receiving centers is problematic and results in delays in care;

2. VATCs apply inconsistent and overly restrictive eligibility criteria in evaluating candidates for liver and kidney transplants, further limiting patients' access to care;

3. Effectively requiring veterans to undergo transplants at one of only six or seven VATCs located throughout the country, or at a handful of affiliated hospitals, often requires veterans and their family members to relocate for weeks or months, causing significant hardship to veterans and a substantial expense for VA;

4. VA medical centers often lack the level of specialty care required to treat and care for post-transplant patients; and

5. VA's unwillingness to perform living donation kidney transplants denies patients timely, life-prolonging treatment options and results in VA spending millions of dollars in dialysis costs.

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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 with reasonable certainty about whether the alleged event or action took place.

After careful review of findings, VA makes the following conclusions and recommendations.

Conclusions for Allegation 1

Although VA substantiates that there were communication problems between the San Antonio Medical Center and the Houston Medical Center prior to 2013, we conclude that the recently installed Director of Transplantation Services at the Houston Medical Center has addressed and resolved the communication concerns of the San Antonio Medical Center staff. However, VA cannot address the allegation that these communication problems resulted in a delay in care until the independent physician review is completed.

Recommendation for Allegation 1

Since the communication problems between the San Antonio and Houston Medical Centers have been addressed, VA does not make a recommendation to those medical centers pending our receipt of the independent physician review.


The conclusions of VA's investigation are pending and will be included with our supplemental report.


The recommendations of VA's investigation are pending and will be included with our supplemental report.

Conclusion for Allegation 3

Although VA agrees that Veterans and their attendants often must travel for pretransplantation evaluation, procedure, and some post-transplantation care, we do not substantiate that this travel is a violation of law, rule or regulation, mismanagement or a substantial and specific threat to public health. We conclude that the system of VATCs, whose survival outcomes are comparable to national survival outcomes, and contracting outside the VATCs if necessary, provides the full range of quality transplantation care.

VA did identify one instance in which Choice Act funds were used to pay for Veteran transplantation care and another instance in which they were used to pay for pretransplantation care. Although there are challenges relating to furnishing

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transplantation care under VCP, such as the limit on rates VA can pay under the program, other contracting vehicles to pay for those costs are available. VA concludes that the reasons for the apparent low usage of the Choice Act authority and funding for transplantation is multifactorial, including comparatively low reimbursement rates available under VCP.

VA also concludes that VHA Handbook 16018.05 does not explicitly provide guidance for living donor travel reimbursement while VHA Directive 2012-018 states that travel for living donors to VATCs is reimbursed.

Recommendation to VHA for Allegation 3

1. Review and consider updating the VHA Handbook 16018.05 so that it conforms to the guidance provided in VHA Directive 2012-018.


Although there is no VA requirement that Veterans who have undergone solid organ transplantation receive their post-operative transplantation care from physicians with a particular level of training, VA is concerned that San Antonio VA Medical Center physicians responsible for caring for patients who have received livers expressed concern about their ability to do so without readily available in-house liver transplantation expertise. However, because the physicians caring for these Veterans had some training and experience in caring for them and because additional expertise was locally available from private medical providers in the San Antonio area, VA does not substantiate that a substantial and specific threat to public health existed. In addition, while VA does not substantiate that a substantial and specific threat to public health existed for patients who had undergone kidney transplantation, we are concerned that without appropriate replacement of the kidney transplantation supervising physician, such a threat could develop.

Recommendations to the San Antonio Medical Center

1. Review the post-transplantation care of all patients who have undergone liver transplantation to ensure the standard of care has been met.

2. Establish a post-liver transplantation care program either with San Antonio VA Medical Center resources or with non-VA providers that ensures that the care standard is met.

3. Ensure that an appropriate kidney transplantation supervising physician is identified either from the San Antonio medical staff or from non-VA providers.

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VA does not substantiate that VHA is unwilling to perform living donor kidney transplantations. However, VA observes that the rate of these transplantations performed at VATCs appears to be lower than the rate in patients undergoing kidney transplantation throughout the United States, even with some correction for age. Although we did not find evidence of barriers to living donor kidney transplantation, we are concerned that this lower rate for Veterans may be the result of one or more barriers that we did not observe.

Recommendation to VHA

2. Through the National Surgery Office, encourage transplantation providers to continue to consider use of living kidney donors and to ensure that there are no barriers to living donor kidney transplantation in all VATCs.

VI. Summary Statement

OMI has developed this report in consultation with other VHA and VA offices to address OSC's concerns that employees who provide transplantation care may have violated law, rule or regulation, engaged in gross mismanagement and abuse of authority, or created a substantial and specific danger to public health and safety. In particular, the Office of General Counsel (OGC) has provided a legal review, and the Office of Accountability Review (OAR) has reviewed the report and has or will address potential senior leadership accountability. VA found no violations of VA and VHA policy, and found no substantial and specific danger to public health.

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Table of Contents

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

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

II. VHA Transplanation Profile and Background ........................................................... 1

111. Allegations .............................................................................................................. 1

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

V. Findings, Conclusions, and Recommendations ....................................................... 2

VI. Summary Statement ............................................................................................. 12

Attachment A .............................................................................................................. 13

Attachment B ................................................................................................................ 14

Attachment C ................................................................................................................ 16

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I. Introduction

The Under Secretary for Health directed the Office of the Medical Inspector (OMI) to assemble and lead a Department of Veterans Affairs (VA) team to investigate allegations lodged with the Office of Special Counsel (OSC) concerning the Veterans Health Administration (VHA) National Transplant Program administered by the National Surgery Office (NSO), in Washington DC and concerning VA Transplant Centers (VATC) located throughout the country. --= = ____,,-.the whistleblower), a registered nurse (RN) and Transplant Program Manager (TPM) at the South Texas Veterans Health Care System, San Antonio, Texas (San Antonio Medical Center) alleged that employees are engaging in conduct that may constitute violations of laws, rules or regulations, gross mismanagement, a gross waste of funds, and a substantial and specific danger to public health.

II. VHA Transplant Program Profile and Background

Human solid organ transplantation is a technically complex therapy in which the functioning organ of one person is implanted in a patient whose organ has failed or is failing.1 This procedure is often lifesaving and VA has provided Veterans with this therapy since 1961. VHA's NSO is responsible for clinical and operational oversight of the 13 VATCs currently performing solid organ and bone marrow transplantation procedures, and for VHA Transplant Program policy development. Of these 13 VA TCs, 12 perform solid organ transplantations of heart, kidney, liver, or lung.2

Between January 1 and December 31, 2015, NSO reported that a total of 319 solid organ transplantation procedures were conducted in VATCs: five VATCs performed 37 heart transplantations, six performed 140 kidney transplantations, six performed 129 liver transplantations, and two performed 13 lung transplantations. Attachment A lists the VATCs where these organ transplantation procedures occurred. During the same period, 1,059 Veterans were evaluated for potential transplantation of these solid organs.

Ill. Allegations

The whistleblower alleged that:

1. Communication between referring and receiving centers is problematic and results in delays in care;

2. VATCs apply inconsistent and overly restrictive eligibility criteria in evaluating candidates for liver and kidney transplants, further limiting patients' access to care;

3. Effectively requiring veterans to undergo transplants at one of only six or seven VATCs located throughout the country, or at a handful of affiliated hospitals, often requires veterans

1 Bone marrow transplantation is also a common transplantation procedure performed by VA but it is not considered solid organ transplantation. Also, in solid organ transplantation procedures, the organ is harvested from a donor, living or deceased; in some bone marrow transplantation procedures, however, the transplanted material may not be harvested from a donor and implanted in the patient. Some bone marrow procedures may be autologous, meaning the transplanted material is harvested from the patient, stored and injected back into the patient after some treatment like chemotherapy or radiation therapy. 2 The San Antonio Medical Center does bone marrow transplantations exclusively.

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and their family members to relocate for weeks or months, causing significant hardship to veterans and a substantial expense for VA;

4. VA medical centers often lack the level of specialty care required to treat and care for post-transplant patients; and

5. VA's unwillingness to perform living donation kidney transplants denies patients timely, life-prolonging treatment options and results in VA spending millions of dollars in dialysis costs.

IV. Conduct of Investigation

The VA team conducting the investigation consisted of lasoecto_r o ~atiooalAssessmeais

Deputy Medical · al Program --HA-CM, and ______ Statistician. We

reviewed relevant policies, procedures, professional standards, reports, memorandums, and other documents, all listed in Attachment B. The VA team interviewed the whistleblower by telephone on May 2, 2016.

We conducted a site visit to the Michael E. DeBakey VA Medical Center, Houston, Texas (Houston Medical Center), on June 6 and 7 and to the South Texas Veterans Health Care System, San Antonio (San Antonio Medical Center) on June 8 and 9, 2016.

On June 6, we held an entrance briefing with the following members of the Houston Medical Center leadership: the Director, the Deputy Director, the Associate Chief for Patient Care Services, the Chief of Staff (CoS) and those interviewed individually listed in Attachment C. The Veterans Integrated Service Network (VISN) 16 personnel participated by conference call. On June 7, we held an exit briefing with leadership. On June 8, we conducted an entrance briefing with the following members of the San Antonio Medical Center leadership: the Cos, the Acting Associate Director, and the Associate Director for Patient Care Services. We individually interviewed the personnel listed in Attachment C, as well as the whistleblower on June 8. On June 9, we held an exit briefing with the CoS, the Acting Associate Director, and the Associate Director for Patient Care Services.

In addition to reviewing policies and procedures and interviewing relevant staff members, we initiated a peer review of the medical records of Veterans who have either undergone the transplantation of a kidney or a liver at a VATC or have been referred for that procedure. We wished to determine whether the standard of care had been met and whether the care had been delivered in a timely manner. We also want to know whether the eligibility criteria VA providers use to evaluate transplantation candidates is consistent with national eligibility criteria. The independent physician reviewers are at work on this project at present; their results will appear in a supplemental report. This report summarizes the findings, conclusions, and recommendations of the VA investigation.

V. Findings, Conclusions, and Recommendations

Allegation 1: Communication between referring and receiving centers is problematic and results in delays in care.

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Findings

As it does bone marrow transplants only, the San Antonio Medical Center refers patients needing solid organ transplantation to other VATCs. Each referral is managed by a nonphysician transplantation coordinator (TC) and overseen by a physician with training in the appropriate specialty. The TCs are responsible for pre-referral evaluation and for coordination with the VATC if transplantation is indicated. The TC usually provides these pre-transplantation services for a specific organ. We interviewed the TC and supervising physician who refer patients for kidney, liver, and lung transplantations and the supervising physician who refers patients for heart transplantation. In addition, the San Antonio Medical Center emoloys a TPM, ______ who assists but does not supervise the TCs . .__ ____ organized the referral process for all transplantation referrals and assisted individual TCs if they ran into difficulty with a VATC on the referral of an individual case. Between June 20, 2013, and June 20, 2016, the San Antonio Medical Center evaluated 113 patients for kidney, 75 for liver, 7 patients for heart, and 6 patients for lung transplantation.

In order to better define the nature of the alleged communication problem, we interviewed the transplantation supervising physicians and TCs at the San Antonio Medical Center because the whistleblower's VA experience is there. The kidney TC and supervising physician told us that in the past they had had difficulties in communicating with the director of the Houston Medical Center Kidney Transplant Program regarding pre- and post-transplantation care. In 2013, however, the Houston Medical Center hired a new director for that program, and according to both the TC and the supervising physician, "Houston is assessing the patients more timely, with an increased willingness to work closely with us on all kidney cases."

The liver TC and supervising physician told us that in the past they had had difficulties in communicating with the consulting liver transplantation specialist at the Houston Medical Center. In particular the supervising physician told us that "it is a little difficult to be communicating by email...l send emails. If I don't hear back, I send another email," but he also told us that " ... it has gotten better for me."

The heart supervising physician told us that although he managed the care of roughly 30 Veterans who had had heart transplantation in the past, he had not referred a patient to a VATC for heart transplantation: all the patients he cares for received their hearts in the private sector, so he has had no experience communicating with VATCs regarding posttransplantation care.

The lung TC and supervising physician told us that they were caring for six posttransplantation Veterans who had all gotten their procedures in a private institution. The TC also said that she had two Veterans who were under evaluation for lung transplantation at the VATC in Madison, Wisconsin, at the time of our interview. She said the communication with that VATC "was fine." The supervising physician had no experience communicating with a VATC directly.

A TC at the VA Texas Valley Coastal Bend Health Care System, Harlingen, Texas told us that she coordinated the pre-transplantation evaluation and the post-transplantation care for Veterans in the Harlingen, Laredo, McAllen, and Corpus Christi, Texas area. She coordinates the care for patients who are being considered for or have undergone

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Employee 1

transplantation of all solid organs. When we asked her if she had trouble communicating with VATCs, she said, "I don't have trouble mostly with the transplant centers."

The San Antonio Medical Center TPM told us that "[it] is so difficult to communicate to try to get your patients [to the Houston Medical Center]." However, he did relate that " ... kidney has gotten better with Houston's kidney proJlram. as far as seeing the patient in a more timely manner and trying to be more involved. -----.---:-:--:---:-c----the new Transplantation Director at the Houston Medical Center] visited us here. He's the only one who's ever visited us from any of the transplant centers."

The quality and timeliness of the care provided to the example patient mentioned in Section I of the Special Counsel's letter to the Secretary will be reviewed by an independent physician reviewer and a supplemental report submitted. This review will include the review of the electronic health record (EHR) of 80 patients who either underwent transplantation therapy or was referred a VATC for consideration of that therapy. These reviews will evaluate whether the standard of care with regard to transplantation therapy was met and whether the therapy was timely. In the instances where the patient did not undergo transplantation therapy, the review will address whether the decision not to recommend that therapy met the standard of care.


Although VA substantiates that there were communication problems between the San Antonio Medical Center and the Houston Medical Center prior to 2013, we conclude that the recently installed Director of Transplantation Services at the Houston Medical Center has addressed and resolved the communication concerns of the San Antonio Medical Center staff. However, VA cannot address the allegation that these communication problems resulted in a delay in care until the independent physician review is completed.


Since the communication problems between the San Antonio and Houston Medical Centers have been addressed, VA does not make a recommendation to those medical centers pending our receipt of the independent physician review.

Allegation 2: VATCs apply inconsistent and overly restrictive eligibility criteria in evaluating candidates for liver and kidney transplants, further limiting patients' access to care;

Findings

This allegation will be addressed by the findings of the independent physician case review explained in the Findings of Allegation 1, above. The findings will be reported in a supplemental report.


The conclusions of VA's investigation are pending and will be included with our supplemental report.

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The recommendations ofVA's investigation are pending and will be included with our supplemental report.

Allegation 3: Effectively requiring veterans to undergo transplants at one of only six or seven VATCs located throughout the country, or at a handful of affiliated hospitals, often requires veterans and their family members to relocate for weeks or months, causing significant hardship to veterans and a substantial expense for VA.

Findings

Organ Transplantation in VATCs

Organ transplantation is one aspect of the comprehensive medical care VA provides to Veterans (38 U.S.C. Chapters 17 and 73; 38 CFR §§ 17.36-17.38). However, the specialized nature of that care is such that most VA medical facilities do not provide it because the number of transplantation cases they might perform is not enough to ensure a quality program.

In order to provide transplantation services, VA has established a VA Transplant Program which includes an extensive network of VATCs, and VHA policy that includes a mandate to provide solid organ transplantation to Veterans within the network of VATCs.3.4 The VA Transplant Program is integrated into the Organ Procurement and Transplant Network (OPTN) and follows national organ transplantation processes established by the United Network for Organ Sharing (UNOS), either as the sole transplantation provider or in collaboration with another institution, usually an academic affiliate that furnishes care pursuant to a contract with VA. 5•6 Organs for Veterans at VAT Cs are procured and distributed under the same guidelines as those procured from and distributed to private and other public institutions. Some VATCs provide the pre-transplantation evaluation, surgical care, and the other aspects of the postoperative transplantation care completely within the VATC. Others provide some of the transplantation-related care and contract with their academic affiliates to provide other aspects of the transplantation care, such as the surgical procedure.

One reason some of the VATCs contract with academic affiliates for this care is to satisfy UNOS case volume requirements. VA cardiac and lung transplantation needs typically are not enough to justify two separate transplantation programs, one at the VA and the other at the affiliate. For example, the heart transplantation program at the Hunter Holmes McGuire VA Medical Center (Richmond Medical Center) in Richmond, Virginia, is uniquely an inhouse program, while some services required for liver transplantation are contracted with Virginia Commonwealth University, as liver transplantation lacks a sufficient case volume to

3 See Attachment A. 4 VHA Directive 2012-018, Solid Organ and Bone Transplantation, July 9, 2012, 5 OPTN is the national network of medical providers established in 1984 that procures and distributes organs for transplantation (42 USC § 274). UNOS is the organization that administers the OPTN under a contract with the US Department of Health and Human Services. 6 An affiliation is a relationship between VA and an educational institution or a health care organization sponsoring educational programs or activities (VHA Handbook 1400.03). These relationships are for the purpose of education, research, and/or enhanced patient care.

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justify delivery of the care solely at the Richmond Medical Center. The VATC with a shared program still has the experts on staff and infrastructure to provide comprehensive pre- and post-transplantation care in house, even though the surgical procedure is performed at the affiliate.

The VA Transplant Program is more than the VATCs providing transplantation care in a stand-alone capacity in that it includes a secure electronic intranet-based system through which the Veteran is referred for transplantation evaluation by the referring VA medical center; travel benefits including lodging which are provided to the Veteran, the caregiver, and the living donor; and telehealth technology which is increasingly used to provide pre- and post-transplantation care, thus minimizing the need for Veteran travel.

In order to reduce the hardship associated with care delivered at a VATC that is distant from the Veteran's home, VA reimburses eligible Veterans and their attendants for the costs of travel under VA's Beneficiary Travel Program and provides temporary lodging where available.7 Also, under paragraph 4.b.(7)-(8) of VHA Directive 2012-018, VA reimburses the Veteran and a support person, and the living donor and a support person for all transplantation-related round-trip travel costs including pre-transplantation evaluation, transplantation episode, and the post-transplantation follow-up. Further, VA absorbs the cost of harvesting the organs either from cadaveric or living donors, along with other clinicallyrelated donor costs when performing transplants at the VATC on the grounds that the donorrelated harvesting and other associated donor costs are integral to (and part and parcel of) VHA delivering the needed care to the Veteran-recipient.

The VA Transplant Program is resourced to provide care and service to Veterans eligible and enrolled across VA's integrated health care system. For the period between July 1, 2015, and June 30, 2016, the VA Transplant Program received 2,627 referrals, performed 1,621 evaluations in a median time of 25 days and placed 767 Veterans on the transplantation waitlist in a median time of 60 days.8 During this period the VA Transplant Program performed 556 solid organ and bone marrow transplants. Moreover, VA provides integrated care and services to more than 10,000 Veterans annually who have received a transplanted organ either in or outside the VA.

Examining the period between October 1, 2013, and June 30, 2016, VA found that 10 percent of the 1,500 Veterans who received transplantation by the VA Transplant Program lived within 100 miles of the VATC. Those Veterans living within 100 miles received an evaluation and were placed on the UNOS transplantation waitlist more quickly than those Veterans who lived greater than 100 miles from the VATC; however, we also found that the distance a Veteran traveled was not related to time to transplantation or to the death of the patient while awaiting a matching organ.

7 38 U.S.C. 101; 38 C.F.R. part 70; VHA Handbook 16018.05, Beneficiary Travel, July 21, 2010; 38 C.F.R. part 60. 8 A referral is an electronic consultation from a VA medical center asking a VATC to consider a specific patient for transplantation therapy. The referral includes some clinical information which allows the VATC to judge preliminarily whether the patient is a transplantation therapy candidate or not. An evaluation follows the referral if the VATC determines that the patient is a transplantation therapy candidate. The patient travels to the VATC for examination and further testing, if required, to determine if the patient should be listed on the waitlist for an available organ. The waitlist is administered by a non-VA organization, United Network for Organ Sharing (UNOS), see above.

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The risks of coordinating care and treatment between two health care systems include duplication of examinations and laboratory tests, and an increased risk of hospitalization. Although this transplantation services coordination between two health care systems has not been specifically studied, transplantation care is complex, and because of this complexity, adverse outcome is likely to be increased when managing care between the VA Transplant Program and a non-VA provider.

The Scientific Registry of Transplant Recipients (SRTR) maintains a database of com~rehensive information, including patient survival, on all solid organ transplantation in the U.S. The VHA NSO maintains a similar database tracking the 3-year survival of Veterans who have had solid organ transplantation at a VATC. Between January 1, 2006, and December 31, 2015, the NSO reports the following 3-year transplant survivals for all VATCs:

Survival Rates after 3 Years, VATC and SRTR

Organ Transplanted 3-Year Survival VATC 3-Year Survival SRTR

Kidney 92.8% 92.8% Liver 77.6% 82.2% Heart 84.8% 84.3% Lung 75.3% 68.8%

In the instance in which Department facilities are not capable of furnishing economical hospital care or medical services because of geographical inaccessibility, or are not capable of furnishing the care or services required, VA is authorized to contract with non-Department facilities to furnish the care or services to eligible veterans, pursuant to 38 U.S.C. 1703 (as implemented by 38 C.F.R. §§ 17.52-17.54). VA may also procure needed hospital care and medical services more broadly through the use of agreements under 38 U.S.C. § 8153.

Organ Transplantation under the Veterans Access. Choice, and Accountability Act

The Veterans Access, Choice, and Accountability Act of 2014 (Public Law 113-146) {Choice Act), as amended, established the Veterans Choice Program (VCP) that authorizes VA to pay for non-VA hospital care and medical services for Veterans who meet VCP eligibility criteria. To participate in VCP, a Veteran must be enrolled in the VA health care system and unable to schedule an appointment within VHA's wait time goals or the clinically-indicated date; reside more than 40 miles from the closest VA medical facility with a full time primary care provider (PCP); or meet one of the unusual or excessive burden provisions.10 To participate in VCP, providers must enter into an agreement with VA, accept rates established through regulations (generally Medicare rates), have the same or similar credentials as VA providers of the same service, and submit a copy of the medical records for medical care and services provided to Veterans for inclusion in the VA electronic record. 11

9 The SRTS operates under a contract from the US government administered by the Health Resources and Services Administration of the Department of Health and Human Services. (See https:/www.ncbi.nlm.nih.gov/pubmed/23481320, accessed November 17, 2016.) 10 See http://www.va.gov/opa/choiceact/index.asp. 11 See http://www.va.gov/opa/choiceact/for_providers.asp.

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If the Veteran and the provider meet the eligibility criteria for VCP, transplantation care may be provided under the Choice Act. As noted above, VA absorbs the cost of harvesting organs either from a cadaveric or living donor, along with other clinically-related donor costs when performing transplants at the VATCs. This justification applies equally to organ transplants performed at VA expense by community providers, including those participating inVCP.

However, as noted above, the payment rate under VCP generally is limited to the Medicare rate. VA's experience has been that community transplantation providers will not agree to accept care of the donor at applicable Medicare rates. For that reason, VA relies on its authority under 38 U.S.C. § 8153 to obtain the associated donor's care from these providers. When purchasing the donor's associated care under an§ 8153 agreement, all the associated clinical donor-related costs can be identified and purchased at a negotiated, mutually agreedupon rate, but this must be done prior to the procedure. This contracting approach has reportedly proven far more successful. Importantly, contracting under§ 8153 for the donorrelated costs does not delay the Veteran's access to care.

In addition to this payment challenge, there have been other issues with VCP implementation. VA believes that the co-payment and cost shares associated with a Veteran's other health insurance have also been a disincentive for some Veterans to opt into the VCP, as some cost shares may not be reimbursed by VA VA can reimburse the Veteran for them as long as the total payment by VA does not exceed the rate established in regulations, generally the Medicare rate (38 CFR § 17 .1535).

VHA Handbook 16018.05 outlines VHA policy regarding reimbursement for Veteran, attendant, and other person travel to VA facilities or to non-VA health care facilities where VA has approved care for an eligible beneficiary at VA expense. However, VHA Handbook 16018.05 does not explicitly address the reimbursement for living donor travel. But VHA Directive 2012-018 paragraph 4.b.(7) does address living donor travel in the instance where the transplantation is performed at a VATC stating:

(7) The Veteran and a support person, and the living donor and a support person, if applicable, are reimbursed for all transplant-related round-trip travel costs including pre-transplant evaluation, transplant episode, and post-transplant follow-up.

In addition, we reviewed VHA records for evidence of payment for transplantation services procured through the VCP. The Office of Community Care (OCC) searched the Medical SAS (MedSAS) Ancillary and Inpatient Datasets for fiscal year 2016 for procedures most commonly associated with transplantation care. 12 The procedures were identified by payments made for services related to inpatient visits occurring between October 1, 2015, and July 20, 2016, and having any of 85 transplantation-related Current Procedural Terminology (CPT) codes. 13 The procedures captured by the CPT codes were bone marrow,

12 SAS: Statistical Analysis System, a software program; MedSAS are comprehensive, administrative SAS-formatted data files that store VHA health care delivery data cumulating inpatient discharge and outpatient encounter information from EHRs to monitor care given to patients at all VA facilities, as well as that given to Veterans at non-VA facilities and paid for

~l i:~ent Procedural Terminology (CPT) is a medical code set that is used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies, and accreditation organizations. CPT codes identify the services rendered rather than the diagnosis on a claim.

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heart, kidney, liver, and lung transplantations. The OCC found 57 instances of one of the CPT codes (observations) for 22 patients and 6 unique codes. The number of observations was greater than the number of patients because some inpatient visits had more than one CPT code. We reviewed the EHR for these patients and found that one patient underwent lung transplantation paid for by VCP in a non-VA medical facility. A second patient received a complete work-up paid for by VCP for bone marrow transplantation at a non-VA medical facility, but did not receive the transplantation because he developed complications. None of the EHRs of the other 20 patients indicated that they had received transplantation care paid for byVCP.


Although VA agrees that Veterans and their attendants often must travel for pretransplantation evaluation, procedure, and some post-transplantation care, we do not substantiate that this travel is a violation of law, rule or regulation, mismanagement or a substantial and specific threat to public health. We conclude that the system of VATCs, whose survival outcomes are comparable to national survival outcomes, and contracting outside the VATCs if necessary, provides the full range of quality transplantation care.

VA did identify one instance in which Choice Act funds were used to pay for Veteran transplantation care and another instance in which they were used to pay for pretransplantation care. Although there are challenges relating to furnishing transplantation care under VCP, such as the limit on rates VA can pay under the program, other contracting vehicles to pay for those costs are available. VA concludes that the reasons for the apparent low usage of the Choice Act authority and funding for transplantation is multifactorial, including comparatively low reimbursement rates available under VCP.

VA also concludes that VHA Handbook 16018.05 does not explicitly provide guidance for living donor travel reimbursement while VHA Directive 2012-018 states that travel for living donors to VATCs is reimbursed.


1. Review and consider updating the VHA Handbook 16018.05 so that it conforms to the guidance provided in VHA Directive 2012-018.

Allegation 4: VA medical centers often lack the level of specialty care required to treat and care for post-transplant patients.

Findings

Post-transplantation care is complex, requiring close medical monitoring of patients to ensure proper administration of potentially toxic immunosuppressive medications. Most PCPs and many specialists rarely have more than one or two post-transplantation patients and lack the expertise to manage them. At the San Antonio Medical Center, all patients who have undergone solid organ transplantation are primarily managed by the organ specific transplantation coordinator and the supervising physician, not by their assigned PCPs.

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The kidney transplantation coordinator and supervising physician related that the renal physician was comfortable with, and very experienced in, caring for post-kidney transplantation patients; however, he was scheduled to retire soon and no physician with similar experience had been named or hired to replace him. The liver transplantation supervising physician felt that she did not have the training to independently care for patients who had undergone liver transplantation.14 Although she supervised the transplantation referral and did provide the post-transplantation care with the assistance of liver transplantation specialists at the Houston Medical Center and at the VA Portland Health Care System, she told us that she did not feel capable of providing the care without that assistance. The VA team also interviewed a gastroenterologist who told us that he also did not feel adequately trained to independently care for patients who had undergone liver transplantation.

The heart transplantation supervising physician told us that he has had training as a heart transplant cardiologist and currently cares for roughly 30 patients who have undergone transplantation. He related that he was "very comfortable" caring for these patients. The lung transplantation supervising physician has had experience with close to 500 lung transplant patients and was also very comfortable caring for them.


Although there is no VA requirement that Veterans who have undergone solid organ transplantation receive their postoperative transplantation care from physicians with a particular level of training, VA is concerned that San Antonio Medical Center physicians responsible for caring for patients who have undergone liver transplantation expressed concern about their ability to do so without readily available in-house liver transplantation expertise. However, because the physicians caring for Veterans who had undergone liver transplantation had some training and experience in caring for these patients and because additional expertise was locally available from private medical providers in the San Antonio area, VA does not substantiate that a substantial and specific threat to public health existed. In addition, VA does not substantiate that a substantial and specific threat to public health existed for patients who had undergone kidney transplantation, though we are concerned that without appropriate replacement of the kidney transplantation supervising physician such a threat could develop.

Recommendations to the San Antonio Medical Center for Allegation 4

1. Review the post-transplantation care of all patients who have undergone liver transplantation to ensure the standard of care has been met.

14 The physician who supervises the liver transplantation referrals told us that she had completed training in internal medicine, 3 years of training after the completion of medical school. A specialist in the diagnosis and treatment of liver diseases would ordinarily undergo the 3-year training as an internal medicine physician followed by at least 3 additional years of training in gastroenterology, the diagnosis and treatment of intestinal diseases. The training in gastroenterology would include some training in the diagnosis and treatment of liver diseases. Often gastroenterologists who specialize in liver transplantation undergo an additional year of training beyond their training in gastroenterology. So a physician fully trained to diagnose and treat patients for their post-liver transplantation condition might have as many as 4 more years of training than the physician who supervised those patients at the San Antonio Medical Center.

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2. Establish a post-liver transplantation care program either with San Antonio Medical Center resources or with non-VA providers that ensures that the care standard is met.

3. Ensure that an appropriate kidney transplantation supervising physician is identified either from the San Antonio medical staff or from non-VA providers.

Allegation 5: VAs unwillingness to perform living donation kidney transplants denies patients timely, life-prolonging treatment options and results in VA spending millions of dollars in dialysis costs.

Findings

Between January 1, 2013, and December 31, 2015, VHA performed 439 kidney transplantations from living and cadaveric donors. 15 During this period, four of the six VATCs performing kidney transplantations did 42 (10 percent) kidney transplantations in which the donor was living. For the period January 1, 2014, through December 31, 2014, VHA performed 146 kidney transplantations with four of the six VATCs performing kidney transplantations doing 12 (8 percent) transplantations in which the donor was living.

For January 1, 2014, through December 31, 2014, the OPTN/SRTR 2014 Annual Data Report (Data Report) reports that of the 17,098 kidney transplantations performed in the United States in 2014, 5,291 (31 percent) kidney transplantations used organs from living donors.16 In the age group of 50 years and older, which is more comparable to the VHA Veteran enrollee population, the Data Report shows that 2,666 (26 percent) of 10, 130 kidney transplantations that were performed in the United States obtained the transplanted organ from living donors.


VA does not substantiate that VHA is unwilling to perform living donor kidney transplantations. However, we observe that the rate of living donor kidney transplantations performed at VATCs appears to be lower than the rate in patients undergoing kidney transplantation throughout the United States, even with some correction for age. Although we did not find evidence of barriers to living donor kidney transplantation, we are concerned that the lower rate of Veterans undergoing living donor kidney transplantation in VATCs may be the result of one or more barriers that we did not observe.

15 In a living donor kidney transplantation procedure, the transplanted organ is harvested from a living person rather than from a cadaver. The advantage of a living donor procedure is that the organ is available sooner than a cadaveric organ and, depending on the familial relationship between the donor and recipient, living donor organ survival may be improved over a cadaveric organ. 16 Hart, A., et.al., Special Issue: OPTN/SRTR 2014 Annual Data Report 2014, American Journal of Transplantation, January 2016, p. 27.

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2. The National Surgery Office encourage transplantation providers to continue to consider use of living donors in kidney transplantation procedures and ensure there are no barriers to living donor kidney transplantation in all VA TCs.

VI. Summary Statement

OMI has developed this report in consultation with other VHA and VA offices to address OSC's concerns that employees who provide transplantation care may have violated law, rule or regulation, engaged in gross mismanagement and abuse of authority, or created a substantial and specific danger to public health and safety. In particular, OGC has provided a legal review, and OAR has reviewed the report and has or will address potential senior leadership accountability. VA found no violations of VA and VHA policy, and found no substantial and specific danger to public health.

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Attachment A

VA Transplant Centers by Solid Organ Transplantation Service Offered during 2015

VATCs performing heart transplantations:

1. William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin; 2. Tennessee Valley Healthcare System, Nashville Campus, Nashville, Tennessee; 3. VA Palo Alto Health Care System, Palo Alto, California; 4. Hunter Holmes McGuire VA Medical Center, Richmond, Virginia; and 5. VA Salt Lake City Health Care System, Salt Lake City, Utah.

VATCs performing kidney transplantations:

1. Tennessee Valley Healthcare System, Nashville Campus, Nashville, Tennessee; 2. Birmingham VA Medical Center, Birmingham, Alabama; 3. Michael E. DeBakey VA Medical Center, Houston, Texas; 4. Iowa City VA Health Care System, Iowa City, Iowa; 5. VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and 6. VA Portland Health Care System, Portland, Oregon.

VATCs performing liver transplantations:

1. Michael E. DeBakey VA Medical Center, Houston, Texas; 2. William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin; 3. Tennessee Valley Healthcare System, Nashville Campus, Nashville, Tennessee; 4. VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; 5. VA Portland Health Care System, Portland, Oregon; and 6. Hunter Holmes McGuire VA Medical Center, Richmond, Virginia.

VATCs performing lung transplantations:

1. William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin; and 2. VA Puget Sound Health Care System, Seattle, Washington.

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Attachment B

1. VHA Directive 2007-015-lnter-Facility Transfer Policy, May 7, 2007. 2. VHA Directive 2009-038, VHA National Dual Care Policy, August 25, 2009. 3. VHA Directive 2012-018 Solid Organ and Bone Marrow Transplantation, July 9, 2012. 4. VHA Directive 2012-033 Heart Failure Treatment Utilizing a Ventricular Assist Device

or Total Artificial Heart: Patient Selection and Funding, November 9, 2012. 5. VHA Directive 1601, NON-VA Medical Care Program, January 23, 2013. 6. VA Directive 1663, Health Care Resources Contracting-Buying Title 38 U.S.C. 8153,

August 10, 2006. 7. VHA Handbook 1101.03 Organ, Tissue, and Eye Donation Process, January 2, 2015. 8. VHA Handbook 1101.11 (2), Coordinated Care For Traveling Veterans. 9. VHA Handbook 1601B.05 Beneficiary Travel, July 21, 2010. 10. VHA Handbook 1102.07 Organ Donation After Circulatory Death (DCD),

November 15, 2013. 11. VHA Handbook 1102.01, National Surgery Office, January 30, 2013. 12. VHA Handbook 1400.03 Veterans Health Administration Educational Relationships,

February 16, 2016. 13. Under Secretary for Health's Information Letter, Hand and Face

TransplantationNascularized Composite Allograft Transplantations, November 8, 2013.

14. Memorandum, Organ Harvest in VHA Operating Rooms, January 29, 2010. 15. Memorandum, Use of Transplant Special Purpose Funding for non-VA Care,

January 12, 2015. 16. VHA Telehealth Services and Office of Surgical Services, Tele Transplant

Operational Manual Supplement 2015. 17. Interim Report to the Office of Special Counsel, VHA National Transplant Program OSC

File No. Dl-14-3637, July 18, 2016. 18. Department of Veterans Affairs, VHA National Surgery Office, Qtr. 1, FY 2016 VA

National Surgery Office Transplant Program Quarterly Report. 19. Department of Veterans Affairs, Office of Inspector General, Healthcare Inspection,

Alleged Program Inefficiencies and Delayed Care, VHA National Transplant Program, Report No. 15-00187-25, November 5, 2015.

20. Department of Veterans Affairs, Office of Inspector General, Healthcare Inspection, Liver Transplant Denial Veterans Health Administration, Report No. 11-03671-207, June 27, 2012.

21. Department of Veterans Affairs, Office of Inspector General, Healthcare Inspection, Alleged Poor Quality of Care and Refusal to Pay for Lung Transplantation, Iowa City VA Health Care System, Iowa City, Iowa, Report No. 15-01968-424, July, 9, 2015.

22. VHA Telehealth Services and Office of Surgical Services, Tele Transplant Operational Manual Supplement 2015.

23. VHA Veterans Choice Program (VCP) Overview, November 20, 2015. 24. VHA Comparison of Choice to Traditional VA and Non-VA Medical Care,

February 22, 2016. 25. VHA Veterans Access, Choice and Accountability Act of 2014 (VACAA), as Amended,

March 8, 2016. 26. 38 USC 8153: Sharing of health-care resources, text contains those laws in effect on

November 14, 2016.

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27. 38 U.S.C. 7301 - Functions of Veterans Health Administration: In general. 28. 38 U.S.C. 1703 - Contracts For Hospital Care And Medical Services In Non-Department

Facilities. 29. 38 CFR 17.53 Limitations on use of public or private hospitals. 30. Federal Practitioner, Pairing and Sharing For Kidney Transplant, Fed Pract. 2016

July; 33(7):e1. 31. E-mail documents of February 5 and June 17, 2013; April 8, August 4, and

November 5, 2014; and April 4, 2016. 32. National Marrow Donor Program, Referral Guidelines, Recommended Timing for

Transplant Consultation, June 2013.

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Employee 1

Attachment C

Houston Medical Center June 6 and 7, 2016

The following members of leadership participated in the Entrance and Exit Briefings either in person or by teleconference:

• • • • • • • • • • • • •

Network Director, VISN 16 Chief Medical Officer (CMO), VISN 16

Quality Management Officer, Quality Management (QM), VISN 16 Medical Center Director

---~ CoS

eputy Cos

Deputy Director

for Patient Care Services Associate Chief of Staff (ACoS), Ambulatory Care

Chief, Transplant Program :,;;;;_=====;;;;;;;;;;-=--:-".'"'"'":"--='

Chief, Surgery Chief, Medicine

,.__ ________ , QM Director

We individually interviewed the following:

. ' Acting Cos

• • • • • • •

Chief, Transplant Program . Chief, Surgery

Cbief, Medicine Chief, Primary Care , Kidney Transplant Surgeon

Kidney Transplant Coordinator/Nurse Kidney Transplant Coordinator/Nurse ...._ _______ _.

San Antonio Medical Center June 8 and 9, 2016

The following employees participated in the Entrance Briefing either in person or by teleconference:

• • • • • • •

. Associate Director for Patient Care Services Chief. Medicine

Chief, QM ----------16

WB

• •

Administrative Officer, QM AFGE Local 4032

We interviewed the following employees individually:

• • • • •

Chief of Staff Transplant Program Manager

Chief of Medicine Chief of Internal Medicine

Gastroenterologist • I . , ICU Director

• • • • • • • • •

=====::::.::::!..H!!:e~ atologist Psychologist

Transplant Coordinator VCB (VANTS line) Renal Transplant Coordinator

=======.;;;;L.;.;.M;..;;;SW, Social Work Bone Marrow Transplant Unit Pulmonary Service

~--~ GI Care Manager Transplant Cardiologist

---------· Renal Transplant

The following employees participated in the Exit Briefing:

• • • • • • •

QMO, VISN 17 Chief Medical Officer, VISN 17

cting Associate Director cos

Associate Director for Patient Care Services __ Chief.QM

Administrative Officer, QM

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January 30, 2017 The Honorable Carolyn Lerner 1730 … FIle DI-14... · supplemental report....

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