VA Health Care: Progress Made Towards Improving Opioid Safety, but Further Efforts to Assess Progress and Reduce Risk Are Needed

The Comprehensive Addiction and Recovery Act of 2016 and Senate Report 114-57 included provisions for GAO to report on VHA's OSI and the opioid prescribing practices of its health care providers.

This report examines, among other issues, (1) the extent to which VHA has met OSI goals established in 2014 and (2) the extent to which VHA providers adhere to key opioid risk mitigation strategies. To do this work, GAO reviewed data and documents related to OSI efforts and goals and interviewed VHA officials. In addition, GAO reviewed a random, nongeneralizable selection of medical records for 103 veterans who were prescribed opioids at five selected VHA medical facilities from March 2016 through March 2017. GAO selected the facilities to obtain diversity in geography and rates of opioid prescribing. At the selected facilities, GAO reviewed facility data and documents related to opioid safety and interviewed officials.

The Veterans Health Administration (VHA) has made progress improving opioid safety through its Opioid Safety Initiative (OSI). Launched in 2013, the OSI aims to help ensure that veterans are prescribed opioids in a safe and effective manner. Since the OSI began, VHA has seen reductions in opioid prescribing rates. For example, from the fourth quarter of fiscal year 2013 to the first quarter of fiscal year 2018, the percentage of patients dispensed an opioid decreased from about 17 percent to about 10 percent, or by about 267,000 veterans. Also, available evidence suggests VHA has accomplished six of nine OSI goals established in 2014; however, it is unclear whether the remaining three goals have been fully met. For example, in the case of OSI goal four (establishing safe and effective regional tapering programs for patients on opioids and benzodiazepines), GAO found that VHA lacked documentation that its regional networks established these programs. VHA also did not establish measures of safety or effectiveness under this goal. These limitations prevent VHA from fully evaluating progress and accurately determining the extent to which its efforts to help ensure safe and effective prescribing of opioids have been successful.

In a review of a nongeneralizable sample of 103 veterans' medical records at five selected VHA medical facilities, GAO found that VHA providers did not always adhere to key opioid risk mitigation strategies, which are required by VHA policy or relevant to OSI goals. For example, among 53 veterans who were prescribed long-term opioid therapy (defined as a 90-day supply in the last 6 months), GAO found that

40 veterans did not have their names queried in a state-run prescription drug monitoring program database. The databases are used to identify patients who are receiving multiple prescriptions that may place them at greater risk for misusing opioids or overdosing;

21 veterans did not have a urine drug screening within the year prior to having their prescription filled. The screenings are used to determine whether veterans are taking their opioid medications as prescribed; and

12 veterans did not provide written informed consent. Informed consent is a formal acknowledgement that the veteran has been educated on the risks and benefits of opioid use prior to initiating long-term opioid therapy.

GAO found several factors that may have contributed to inconsistent adherence to key opioid risk mitigation strategies at the selected VHA facilities. For example, four of the five selected facilities did not have a pain champion (a primary care position required by VHA that can help providers adhere to opioid risk mitigation strategies), and not all facilities had access to academic detailing, a program in which trained clinical pharmacists work one-on-one with providers to better inform them about evidence-based care related to the appropriate treatment of relevant medical conditions. In addition, three of the five facilities did not consistently review veterans' medical records to ensure provider adherence to these strategies. To the extent that these factors affect all VHA facilities, VHA will continue to face challenges ensuring that its providers prescribe opioids in a safe and effective manner.

GAO is making five recommendations to VHA, including that it document actions and develop measurable outcomes related to its OSI goals, ensure that providers are adhering to opioid risk mitigation strategies, and ensure that all its regional networks have implemented academic detailing programs and that all VHA medical facilities have a designated primary care pain champion, as required. The Department of Veterans Affairs concurred with GAO's recommendations and described steps it will take to implement them.

The United States is in the midst of an unprecedented opioid epidemic.  According to 2016 data from the Substance and Mental Health Services  Administration, nearly 12 million people age 12 or older misused opioids  in the previous year. In addition, Centers for Disease Control data show  that over 42,000 people died as a result of an opioid overdose in 2016— either from prescription opioids or illicit opioids such as heroin—a fivefold  increase since 1999. According to the Department of Veterans Affairs’  (VA) Veterans Health Administration (VHA), veterans are twice as likely to  die from an accidental overdose when compared to the non-veteran  population.

VHA has found that in its primary care settings, more than 50 percent of  male veterans report having chronic pain, and the incidence among  female veterans may be higher. To help ensure that veterans are  prescribed and use opioid pain medications in a safe and effective  manner, VHA launched its national Opioid Safety Initiative (OSI) in 2013.  In 2014, VHA established a number of goals and requirements under the  OSI aimed at improving the safety and care of veterans who are  prescribed opioids for pain. In addition, in 2017, VA, along with the  Department of Defense (DOD), updated its clinical practice guidelines  related to opioid therapy for chronic pain to increase providers’  awareness of evidence-based pain management practices.

The Comprehensive Addiction and Recovery Act (CARA) of 2016  requires VA to implement a number of efforts aimed at improving opioid  safety for veterans. CARA also includes a provision for GAO to assess  VHA’s recent efforts under the OSI as well as the opioid prescribing  practices of VHA health care providers. In addition, a Senate Report  accompanying H.R. 2029, enacted as the 2016 Consolidated  Appropriations Act, included a provision for GAO to review the  effectiveness of the OSI and overall opioid prescribing patterns  throughout VHA. In this report, we  1.  describe key efforts VHA has undertaken since 2013 as a part of the  2.  examine the extent to which VHA has met its OSI goals established in  2014 and implemented certain provisions of CARA related to  monitoring veterans who are prescribed opioids; and  3.  examine the extent to which VHA providers adhere to selected opioid  risk mitigation strategies and clinical practice guideline  recommendations related to prescribing opioids.

To describe key efforts VHA has undertaken since 2013 as a part of the  OSI, we reviewed VHA documents and interviewed VHA Central Office  officials regarding OSI efforts, including VHA efforts to monitor and  address opioid prescribing patterns. We also analyzed data VHA collects  under the OSI on four metrics related to rates of opioid prescribing and  urine drug screening among certain veterans from the fourth quarter of  fiscal year 2013 (roughly when the national OSI began at VHA) to the first  quarter of fiscal year 2018, the most current quarter of data available at  the time of our review. We also analyzed VHA data from its academic  detailing programs on the frequency with which program representatives  consulted with VHA providers on issues related to opioid safety. We  assessed the reliability of the data sources by reviewing relevant  documentation, interviewing knowledgeable agency officials, and  reviewing the data for missing values and outliers. Through these steps,  we determined that the data were sufficiently reliable for the purposes of  this reporting objective.

To examine VHA’s progress on its 2014 OSI goals, we reviewed VHA  documents and data relevant to OSI goals, including VHA opioid safety  training data and OSI metric data. We also interviewed VHA Central  Office officials, selected Veteran Integrated Service Network (VISN)  officials, and VHA medical facility officials from 5 of 170 VHA medical  facilities that we selected for our review. We selected the 5 VHA medical  facilities based on variation in geography and to reflect the full range of  variation in the rate of change over time in the percentage of veterans  who have been prescribed an opioid. Our findings from the selected  facilities are not generalizable to all VHA medical facilities. We examined  VHA’s progress on its OSI goals in the context of federal internal control  standards for documentation requirements and the establishment and  review of performance measures and indicators. We assessed the  reliability of the data sources by reviewing relevant documentation,  interviewing knowledgeable agency officials, and reviewing the data for  missing values and outliers. Through these steps, for the purposes of this  reporting objective, we determined that the VISN-level opioid safety  training assignment data were not reliable; however, all other data  sources we analyzed were sufficiently reliable. To assess whether VHA is  meeting certain provisions of CARA related to monitoring veterans who are prescribed opioids, we interviewed VHA Central Office officials and  reviewed documents related to these provisions.

To examine the extent to which VHA providers adhere to selected opioid  risk mitigation strategies and clinical practice guideline recommendations  related to prescription opioid therapy, we focused on three key VHA  opioid risk mitigation strategies and three VA/DOD clinical practice  guideline recommendations—all of which, generally speaking, are strong  evidence-based strategies for reducing the potential health risks  associated with opioid use. The three opioid risk mitigation strategies  are the following: an annual urine drug screening for patients on long-term opioid  therapy (defined by VHA as having had a 90-day supply in the last 6  months; increasing these screenings is an explicit goal of the OSI; a VHA-required annual query of a prescription database maintained  by a state prescription drug monitoring program when prescribing  controlled substances, including opioids, to check for whether patients  are receiving multiple prescriptions; and obtaining written informed consent from patients on the use of opioids  so that they have an informed understanding of the medications’ risks  and benefits, as required by VHA policy.

The three clinical practice guideline recommendations are the following:  the use of non-pharmacological treatments (such as cognitive  behavioral therapy and yoga) in addition to or in lieu of opioid therapy;  the prescribing of naloxone to help reverse opioid overdoses; and appropriate follow-up visits with a provider after an opioid is  prescribed and after an opioid prescription is changed.

To assess adherence to these opioid risk mitigation strategies and  guideline recommendations, we reviewed a random, nongeneralizable  sample of medical records for 103 veterans who had received long-term  opioid therapy between March 1, 2016 and March 31, 2017. The 103  records we reviewed included a minimum of 20 records each from our  five selected facilities. The sample of records also included records for 50  veterans at a greater risk of adverse events due to opioid use, including  25 veterans who received benzodiazepines concurrently with an opioid  and another 25 veterans who were categorized as “very high” risk in  VHA’s opioid safety monitoring tool, the Stratification Tool for Opioid Risk  Mitigation (STORM), during the summer and fall of 2017 when the  medical record review was conducted. As part of our work, we also  reviewed relevant documents and interviewed officials from the five  selected VHA medical facilities, the VISNs associated with the facilities,  and VHA Central Office.

We conducted this performance audit from November 2016 to May 2018  in accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

To help ensure that veterans are prescribed and use opioid pain  medications in a safe and effective manner, VHA launched its OSI  nationally in 2013. VHA established nine OSI goals in a December 2014  memorandum. For each of the goals, VHA directed its VISNs and their  associated VHA medical facilities to take specified actions to meet the  goals. (See table 1.)

VHA has also developed opioid risk mitigation strategies for its providers  to follow when prescribing opioid pain medications to veterans. These key  strategies include one whose increased use is an explicit goal for the OSI  and two that are requirements in VHA policy.  1.  Annual urine drug screening for veterans on long-term opioid therapy.

Providers should generally ensure that a urine drug screening has  been conducted for veterans who are on long-term opioid therapy at  least once in the 365 days prior to initiating or renewing an opioid  prescription. Urine drug screening allows providers to monitor the  types of drugs that are in a veteran’s system, including controlled and  illicit substances. Increasing the use of urine drug screening is OSI  goal two.  2.  Annual prescription drug monitoring program (PDMP) query. PDMPs  are state-run electronic databases used to track the prescribing and  dispensing of prescriptions for controlled substances, identify  suspected misuse or diversion (i.e., channeling drugs into illegal use),  and identify trends in drug utilization. In 2016, VHA began requiring in  policy that providers query state PDMPs at least once annually when  prescribing opioids to determine whether their patients have received  prescriptions for opioid medications or other controlled substances  from non-VA providers.  3.  Informed consent for long-term opioid therapy. In 2014, VHA began  requiring in policy that providers educate their patients on the risks  associated with the use of prescription opioids and to obtain veterans’  formal acknowledgment of these risks in writing prior to initiating long- term opioid therapy.

Clinical Practice Guidelines for the Treatment of Chronic Pain

In 2010, in coordination with DOD, VA developed clinical practice  guidelines for its providers to use when prescribing opioids for chronic  pain. These guidelines were updated in 2017. While clinical practice  guidelines contain evidence-based recommendations, they are not  required to be followed in all clinical situations; therefore, variations in  practice may occur based on individual patient needs subject to the  discretion of the provider.

The 2017 VA/DOD clinical practice guidelines related to opioid therapy for  chronic pain generally complement VHA’s OSI goals. For example, the  guidelines recommend a conservative use of opioids for chronic pain and  emphasize strategies to mitigate the risk of using opioids. The evidence- based clinical practice guideline recommendations include the following:  1.  Use of non-pharmacological treatments. The guidelines advise not  initiating opioid therapy for chronic pain. They also recommend  alternatives to opioid therapy, such as non-opioid medications and  non-pharmacological treatments. Non-pharmacological treatments for  chronic pain include, for example, cognitive behavioral therapy and  yoga.  2.  Naloxone prescribing. Naloxone is a highly effective, potentially life- saving intervention for reversing opioid overdoses, and it can be  prescribed to veterans as a preventive measure. Veterans who are  prescribed naloxone can use it when experiencing an overdose or a  family member can administer it on their behalf. According to the  clinical practice guidelines, naloxone should be offered as an antidote  to all patients at risk for an opioid overdose, including those who are  in the process of tapering from opioids. The guidelines describe  several significant risk factors which can indicate the prescribing of  naloxone, including the duration and dose of opioids, current or  history of depression or substance use disorder, and suicidality.  3.  Appropriate follow-up visits with a provider. According to the  guidelines, follow-up pain management visits should be scheduled at  least every 1-4 weeks after any change in medication regimen and at  least once every 1-3 months for the duration of the therapy to help  ensure that the treatment plan is optimized.

Under Its OSI, VHA Tracks Opioid Prescribing Patterns, Identifies Prescribing Outliers, and Educates Prescribers

VHA officials told us that the main focus of the OSI is changing the  prescribing patterns of providers to better align with evidence-based  practices. We found that this has been carried out by VHA through three  key efforts: tracking opioid prescribing rates and other trends, identifying  irregular prescribing patterns, and educating providers on best practices  through academic detailing.

Tracking Opioid Prescribing Patterns. Under the OSI, VHA uses quarterly  data derived from VHA’s electronic medical record system to monitor  prescription opioid use among veterans, the related prescribing patterns  of VHA providers, and the rates of urine drug screening for veterans  receiving long-term opioid therapy. Specifically, VHA tracks the  following four clinical indicators, known as the OSI metrics, for each of its  medical facilities:  1.  the percentage of patients dispensed an opioid,  2.  the percentage of patients dispensed an opioid and a benzodiazepine,  3.  the percentage of patients on long-term opioid therapy who received a  urine drug screen within the previous year of having their prescription  filled, and  4.  the percentage of patients dispensed greater than or equal to 100  morphine milligram equivalents per day.

Our analysis of quarterly OSI metric data shows that since the beginning  of the OSI in the fourth quarter of fiscal year 2013 to the first quarter of  fiscal year 2018 (the most recent data available at the time of our review),  the percentage of veterans dispensed an opioid has decreased by 7  percentage points, or roughly 267,000 veterans, while the rate of urine  drug screening for veterans on long-term opioid therapy increased  significantly—by over 47 percentage points. The increase in the  percentage of patients receiving a urine drug screening was driven more  by a reduction in the total number of patients on long-term opioid therapy  (about 197,000 veterans) than an increase in the number of patients  receiving the screening (about 27,000 veterans). (See table 2.)

Identifying Irregular Prescribing Patterns. As part of its monitoring of the  OSI metrics, VHA Central Office has periodically identified VHA medical  facilities and VHA providers who deviate from average prescribing rates  across VHA. For example:

Facilities. In 2014, VHA Central Office identified 39 of 140 medical  facilities across 12 VISNs with relatively higher rates of opioid  dispensing as outliers based on the OSI metric percentage of  veterans dispensed an opioid. VHA Central Office notified the VISNs  of these facilities and required each facility to submit a corrective  action plan to VHA Central Office outlining the actions they would take  to reduce opioid prescribing. Based on our analysis of VHA  documents, we found that the identified facilities in the five VISNs  selected for our review submitted information in response to VHA  Central Office’s request.

Providers. In February 2017, VHA Central Office identified 320  outliers out of 8,351 providers at 94 VHA medical facilities based on  the relatively high proportion of their patients who were prescribed  opioids. VHA Central Office directed the VHA medical facilities  associated with these outlier providers to review their prescribing  rates in the context of their clinical practice, and to report back with  any feedback given or actions taken. According to officials from the  five facilities in our review, outlier providers tended to be surgeons,  pain management specialists, or physical rehabilitation providers who  might be expected to prescribe opioids at a higher-than-average rate  due to the nature of their specialty and the types of patients they treat.  According to a VHA Central Office progress report, the facilities  provided feedback and follow-up actions for 319 out of 320 outlier  providers. In May 2017, VHA identified a second round of 303  outliers out of 8,505 providers; 187 of these providers were previously  identified as outliers in February 2017. According to one VHA  Central Office official, as of September 2017, VHA was reviewing  these outlier data and will evaluate whether VHA facilities will be  asked to conduct further reviews of these prescribers.

Educating Providers through Academic Detailing. To help change the  prescribing patterns of providers, VHA has also implemented a system- wide academic detailing program to educate providers and improve the  delivery of evidence-based health care at facilities. In 2015, VHA required  each VISN to establish such a program to improve performance on all  OSI metrics. According to VHA Central Office officials, academic  detailers are responsible for reviewing facility-level data on the  prescribing patterns of providers and identifying potential areas of  improvement. Detailers can educate providers with higher-than-average  prescribing rates—such as those outliers identified in February and May  2017 by VHA Central Office—to help ensure providers are delivering safe  and effective care for pain.

According to VHA, as of January 2018, academic detailers have  conducted over 20,000 opioid-related visits to VHA providers. According  to VHA officials, their data also show that academic detailing results in  greater patient safety for veterans taking opioids. For example, compared with those who did not receive academic detailing visits, providers who  did receive such visits experienced (1) greater reductions in the  proportion of their patients on high-dose opioids, (2) reductions in their  patients’ average morphine milligram equivalent daily dosage, and (3)  increases in their naloxone prescribing rates.

VHA Has Made Progress on OSI Goals, but Performance Measurement Limitations Exist for Some Goals and Certain CARA Provisions Have Not Been Fully Implemented

VHA Has Made Progress on Many 2014 OSI Goals, but for Some Goals, Performance Measurement Limitations Prevent an Accurate Determination of their Completion

Based on our analysis of VHA information, we found evidence suggesting  that the agency has accomplished six of the nine 2014 OSI goals. For  example, the agency has seen increases in the use of urine drug  screening for veterans on long-term opioid therapy, and it has developed  provider tools to identify veterans at a higher risk for adverse events while  using opioids. For several goals, although VHA did not implement the  actions required in all those instances, the agency provided us with  information or data demonstrating that the goals had effectively been met.  However, for three OSI goals, it is unclear if the goal has been fully met  because VHA lacks documentation showing that it has implemented the  required action under the goal or the required action is still in progress.  (See table 3.)  (See appendix I for a more detailed description of VHA’s known efforts  and data related to each goal).

When asked about the lack of documentation for two of its OSI goals  (goals four and seven), VHA officials told us that relevant documentation  could not be produced. This lack of documentation is inconsistent with  federal internal control standards. Specifically, according to federal  internal control standards, management should evaluate and document  the results of monitoring. By not documenting the actions it is taking  under each of its OSI goals, VHA lacks assurance that these actions have  been implemented by the VISNs or VHA medical facilities. As a result,  VHA does not know whether it has fully met these OSI goals.

Moreover, for the OSI goal related to establishing safe and effective VISN  tapering programs for veterans using opioids and benzodiazepines (goal  four), VHA officials told us that they addressed this goal by issuing  national tapering guidance, including a provider reference guide in 2014,  an opioid taper decision tool in 2016, and the VA/DOD clinical practice  guidelines in 2017. However, these actions do not appear to be sufficient  for meeting the goal as it is currently written, because issuing national  guidance alone does not ensure that safe and effective tapering programs  are established. Furthermore, VHA did not specify how safety and  effectiveness within a tapering program would be measured, nor did the  agency specify a deadline for the required action as described in  December 2014. According to federal internal control standards relating  to the establishment and review of performance measures and indicators,  government agencies should use appropriate information to adequately  assess performance, including establishing milestones or numerical  targets, as appropriate. Without clearly defined and measurable  outcomes, VHA cannot fully assess its progress towards meeting this OSI  goal.

VHA Has Not Implemented Certain CARA Requirements Related to Monitoring Veterans Prescribed Opioids

We also found that VHA has not implemented two CARA requirements  intended to improve opioid safety for veterans. First, CARA requires that  VHA’s Opioid Therapy Risk Report (OTRR) have the ability to determine  whether a provider has prescribed opioids to a veteran without checking  that veteran’s information in the OTRR. Available to providers through  VHA’s electronic medical record system, OTRR is a clinical tool that  provides information on any opioid and concurrent benzodiazepine  prescriptions a veteran is receiving, the veteran’s current and prior health  conditions, recent and upcoming appointments, and whether any opioid  risk mitigation strategies have been employed (such as urine drug  screening or PDMP query). However, we found that VHA Central Office  cannot track the extent to which VHA providers use OTRR because this  tool does not have this tracking capability. VHA officials said that adding  tracking capabilities to OTRR is not a high priority for the agency due to  limited resources and competing priorities. Instead, according to a draft  memorandum, VHA Central Office is planning to address this CARA  provision by requiring VHA providers to document the use of OTRR in a  standardized way that VHA can monitor. However, as of March 2018,  VHA has not established this requirement or outlined the process for  monitoring providers’ use of OTRR. Without the ability to track the use of  OTRR, VHA cannot sufficiently monitor whether providers are using the  tool to help reduce the likelihood of opioid-related adverse events  occurring among veterans receiving care through VHA.

CARA also requires that VHA modify its electronic medical record system  so that any provider who accesses the record of a veteran will be notified  whether that veteran is receiving opioid therapy and has a history of  substance abuse disorder or prior instances of overdose; has a history of  opioid abuse; or is at risk of developing an opioid use disorder. However,  we found that VHA does not plan to modify its electronic medical record  system to implement this capability. When asked about this provision in  CARA, VHA officials said that VHA’s medical record currently has real- time alerts to inform providers about veterans’ existing opioid  prescriptions and that any patient exposed to an opioid could be at risk of  developing an opioid use disorder. Additionally, they said that an alert  regarding current or past history of opioid use disorder could have an  unintended consequence of discouraging veterans from reporting their  medical history due to the stigma surrounding drug use disorders.

VHA Providers Do Not Always Adhere to Required Opioid Safety Risk Mitigation Strategies and Guideline Recommendations for Prescribing Opioids in a Safe Manner

VHA Providers at Selected Medical Facilities Do Not Consistently Follow Opioid Risk Mitigation Strategies

Our review of selected VHA medical facilities shows that providers do not  always follow three key opioid risk mitigation strategies, two of which are  required under VHA policy. Specifically, increasing the use of urine drug  screening is an explicit goal of the OSI, and providers should generally  ensure that an annual urine drug screening has been conducted. VHA  policy requires providers to 1) query state PDMPs at least annually when  prescribing opioids to determine if the veteran has obtained opioid  medications or other controlled substances from a non-VA provider and  2) obtain written informed consent from patients about the risks of  initiating long-term opioid therapy. These strategies are intended to help  ensure that patients at VHA medical facilities are safely prescribed opioid  medications. Overall, based on our review of 103 veterans at five  selected facilities, we found that 75 percent of the veterans in our sample  had an annual urine screening, 26 percent had their names queried in a  PDMP, and 70 percent provided informed consent.

Provider Adherence to Three Veterans Health Administration (VHA) Opioid Risk Mitigation Strategies at Five Selected  Medical Facilities, March 2016 through March 2017 Increasing the use of urine drug screening is an explicit goal of VHA’s Opioid Safety Initiative (OSI), and providers should generally  ensure that an annual urine drug screening has been conducted. VHA policy requires providers to (1) query state prescription drug  monitoring programs (PDMP) at least annually when prescribing opioids to determine if the veteran has obtained opioid medications  or other controlled substances from a non-VA provider, and (2) obtain written informed consent from patients about the risks of  initiating long-term opioid therapy. However, our review of medical records for a random nongeneralizable selection of 103 veterans  subject to these risk mitigation strategies found that  Of the 53 veterans who received long-term opioid therapy:  32 veterans received an annual urine drug screening, which allows providers to monitor the types of medications in a  veteran’s system, including controlled and illicit substances;  13 veterans had their names queried annually in a state PDMP to see if they had received prescriptions for controlled  substances, including opioids from non-VHA prescribers; and  41 veterans had provided informed consent indicating that they had been educated on the risks and benefits of opioid use.

Of the 25 veterans prescribed an opioid and benzodiazepine concurrently:  17 veterans received an annual urine drug screening;  8 veterans had an annual PDMP query; and  22 veterans had provided informed consent.

Of the 25 veterans with the highest risk of an adverse event, such as a suicide, overdose, fall, or accident, based on their Stratified  Tool for Opioid Risk Mitigation (STORM) risk score:  24 veterans received an annual urine drug screening;   5 veterans had an annual PDMP query; and  11 veterans had provided informed consent.

We identified a number of factors that may have contributed to the  inconsistent adherence to the three key opioid risk mitigation strategies at  our selected VHA medical facilities. These factors may impede providers’  ability to consistently follow these strategies for all applicable patients at  these facilities. To the extent that these factors are present across other  facilities, VHA’s ability to ensure that all veterans are prescribed opioids in  a safe and effective manner may be limited.

PDMP access issues. Officials at four of the five selected medical  facilities faced PDMP access issues. Officials at two facilities told us that  not all facility staff can access state PDMPs due to state laws and  regulations that do not allow access to all types of providers, such as  nurses and pharmacists. Officials at one of these selected facilities  explained that nurse practitioners in that state cannot access the state’s  PDMP, so they must rely on other providers to obtain information from the  PDMP about their patients. In addition, in some states, only providers  licensed in the state may access the state’s PDMP. Because providers at  VHA facilities may not be licensed in the state where the VHA facility is  located but licensed in another state, these providers may be unable to  access the state’s PDMP. Officials at two selected facilities also  described difficulties accessing PDMPs in neighboring states that are part  of the catchment area for the facility and where the veteran may reside.  The low rates of adherence we identified may also be attributed to the  fact that VHA did not require providers to query the PDMP until October  2016, 7 months into our review of patients from March 2016 to March  2017.

CARA directed VA to ensure access by VHA providers to information on  controlled substances prescribing through state PDMPs, including by  seeking to enter into memoranda of understanding with states to allow  shared access of such information between states and the VA. According  to VHA officials, VHA Central Office has not taken steps to develop  memoranda of understanding with states, nor has it developed any  related guidance. Officials said this issue is likely being addressed by  individual VISNs and medical facilities. In addition, VHA officials told us  they have communicated with Members of Congress and the National  Governors Association to address issues related to VHA provider access  to the state PDMPs.

Lack of required staff to support providers. We also found that not all of  the selected medical facilities and their respective VISNs had filled  required staff positions that can help ensure provider adherence to opioid  risk mitigation strategies—specifically, academic detailers and pain  champions.

At the time of our review, not all facilities had access to VISN  academic detailing services, which, according to VHA, can help  ensure that providers follow opioid risk mitigation strategies. While  VHA officials said that most VISNs across VHA had implemented an  academic detailing program as required by VHA policy, two of the five  VISNs for the selected facilities in our review had not. Nationally, as  of March 2018, four VISNs had not implemented an academic  detailing program. Additionally, 11 facilities across VHA had not  received a visit from a detailer.

At the time of our review, four of five selected facilities did not have a  Pain Champion as required by VHA policy beginning in March 2015.  Pain champions are generally primary care providers knowledgeable  about pain care who can serve as a resource for other primary care  providers by promoting safe and effective pain care. According to  VHA officials, pain champions play a critical role in opioid safety and  can help providers remedy gaps in pain care management for  individual patients, such as incomplete opioid risk mitigation  strategies.

Lack of clinical opioid safety alerts. Another factor that may limit  adherence to the opioid risk mitigation strategies is the fact that none of  the selected facilities employ electronic reminders to help remind primary  care nurses of strategies that have not been completed. Primary care  nurses are typically responsible for ensuring adherence to these  strategies, and VHA facilities often employ electronic alerts to notify  providers when certain tasks need to be completed, such as regular  screenings for depression and traumatic brain injury. Although VHA  facilities are not required to develop these alerts, according to some  primary care nurses we interviewed, it would be helpful to receive a  reminder when a veteran is due for a PDMP query, urine drug screening,  or has not given long-term opioid use informed consent. According to the  nurses, such an alert could be issued through the electronic medical  record system.

Limited facility monitoring. We found that facilities’ monitoring of provider  adherence to the opioid risk mitigation strategies was limited across the  five selected facilities in our review, which could hinder identification of  non-adherence to these strategies. Specifically, while we found that all  five medical facilities and VISNs in our review have an active pain  management committee, facility officials told us that three of five facility  committees do not conduct regular medical record reviews, which VHA  encourages under its pain management directive to improve pain  management. The directive states that facility pain management  committees should monitor the pain management practices at their  facility. For example, the pain management committee could monitor  providers’ care plans for individual veterans, which are to be documented  in the veterans’ medical records. These types of medical record reviews  could help identify providers who are not adhering to VHA’s opioid safety  requirements.

Some VHA Providers Do Not Consistently Follow Clinical Practice Guideline Recommendations Related to Opioid Safety

We also found that some VHA providers at selected facilities do not  consistently follow selected clinical practice guideline recommendations  related to opioid safety. Our findings are based on our review of a random  selection of medical records for 103 veterans prescribed opioids between  March 2016 and March 2017. These guidelines recommend, for example,  that providers consider using non-pharmacological treatments, such as  acupuncture and yoga, for chronic pain and prescribe naloxone, a  potentially lifesaving drug, as warranted. The guidelines provide  evidence-based recommendations designed to assist in provider  decision-making; however, they are not VHA requirements and variations  in practice will occur based on provider discretion and the needs of  individual patients. Overall, we found that, 20 percent of veterans in our  sample were prescribed a non-pharmacological therapy, 23 percent of the  veterans were prescribed naloxone, 54 percent had appropriate  maintenance follow-up visits with a provider while prescribed opioids, and  17 percent had appropriate follow-up visits with a provider after a change  in their opioid prescription.

Provider Adherence to Selected Clinical Practice Guideline Recommendations for Management of Opioid Therapy for  Chronic Pain at Five Selected Veterans Health Administration (VHA) Medical Facilities, March 2016 through March 2017 Clinical practice guidelines provide evidence-based recommendations designed to assist in provider decision-making; however, they  are not VHA requirements and variations in practice will occur based on provider discretion and the needs of individual patients. Our  review of medical records for a random, nongeneralizable selection of 103 veterans subject to the recommendations found that   Of the 53 veterans who had been prescribed long-term opioids:  11 veterans were prescribed a non-pharmacological therapy, such as yoga, or cognitive behavioral therapy;  13 veterans were prescribed naloxone, which is a highly effective intervention for reversing an overdose;  29 veterans had a maintenance follow-up visit at least once every 30-180 days for the duration of the veteran’s opioid  therapy; and  3 of 21 veterans who had a change in their opioid medication during the time of our review had a follow-up visit between 14  and 28 days following the change.

Of the 25 veterans prescribed a concurrent opioid and benzodiazepine:  6 veterans were prescribed a non-pharmacological therapy;  4 veterans were prescribed naloxone;  11 veterans had a maintenance follow-up visit; and  0 of 9 veterans who had a change in their opioid medication during the time of our review had a follow-up visit between 14  and 28 days following the medication change.

Of the 25 veterans with the highest risk of an adverse event, such as a suicide, overdose, fall, or opioid-induced respiratory  depression, based on their Stratified Tool for Opioid Risk Mitigation (STORM) risk score:  4 veterans were prescribed a non-pharmacological therapy;  7 veterans were prescribed naloxone;  16 veterans had a maintenance follow-up visit; and  5 of 17 veterans who had a change in their opioid medication during the time of our review had a follow-up visit between 14  and 28 days following the medication change.

There are a variety of reasons that VHA providers may not always follow  clinical practice guideline recommendations. For example, the availability  of these non-pharmacological therapies may be limited, according to  officials at all five selected VHA medical facilities. Officials at some  facilities noted that the availability of these therapies can be particularly  challenging for facilities in rural areas.

VHA officials explained that the biggest barrier to providing naloxone is  educating providers, so that they consistently consider prescribing  naloxone for their patients receiving opioid therapy. According to  officials, an education course for providers on naloxone prescribing  became available in December 2015, and naloxone education efforts are  a key focus of academic detailing programs. According to VHA data,  since fiscal year 2014, naloxone distribution has increased. Specifically,  as of March 2018, the agency has dispensed almost 142,000 naloxone  kits to veterans, an increase of about 58 percent since June 2017.

VHA is taking important steps under the OSI to help ensure that veterans  receive safe care. For example, VHA has begun tracking and publicly  reporting data on four key metrics related to opioid prescriptions, and  these data show that opioid prescription rates have decreased since  2013. In addition, our review also found that VHA has made progress on  most of its 2014 OSI goals. However, for two goals, VHA lacks  documentation showing whether VISNs and medical facilities have  completed required relevant actions, and in one case, VHA has not  specified measurable outcomes, which makes it challenging to determine  whether these goals have been accomplished. Without sufficient  documentation and measurable outcomes, VHA cannot determine  whether these OSI goals to help ensure safe and effective care for  veterans prescribed opioids have been fully successful.

Our review also shows that VHA needs to do more to ensure that its  providers are following three key opioid risk mitigation strategies when  prescribing an opioid medication to a veteran: conducting an annual urine  drug screening, querying a PDMP, and obtaining written informed  consent from the veteran on the benefits and risks of using opioid  medications.

VHA has several means at its disposal for improving adherence to these  strategies—at a minimum it should ensure that each VISN has a fully  staffed academic detailing program and that each facility has a  designated primary care pain champion, as VHA policy requires. In  addition to enforcing these requirements, VHA should direct its facilities to  strengthen monitoring efforts to help ensure providers’ adhere to the  opioid risk mitigation strategies. These efforts include regular reviews of  veterans’ medical records and creating electronic alerts reminding  providers when these risk mitigation strategies have not been completed.  Academic detailers and pain champions would also help educate  providers further about evidence-based clinical practice guideline  recommendations, such as non-pharmacological alternatives to opioid  therapy and prescribing naloxone. Without these efforts to improve  adherence to key opioid risk mitigation strategies, VHA’s ability to ensure  that all veterans are prescribed opioids in a safe and effective manner  may be limited.

We are making the following five recommendations to VA:

The Undersecretary for Health should ensure that Central Office,  VISNs, and medical facilities document the actions they take towards  achieving OSI goals. (Recommendation 1)

The Undersecretary for Health should ensure that any OSI goals that  have not been met have clearly defined, measurable outcomes,  including milestones or numerical targets, as appropriate, and  timeframes. (Recommendation 2)

The Undersecretary for Health should track the use of the OTRR (or  any subsequent tool) by providers prior to initiating opioid therapy.  (Recommendation 3)

The Undersecretary for Health should ensure that all VISNs have  implemented an academic detailing program that supports all medical  facilities in the VISN and that all VHA medical facilities have a  designated primary care pain champion as required.  (Recommendation 4)

The Undersecretary for Health should require VHA medical facilities to  take steps to ensure provider adherence to opioid risk mitigation  strategies, including querying PDMPs, obtaining written informed  consent, and conducting urine drug screening. For example, these  steps could include creating alerts in the electronic medical record  system to remind primary care teams when these actions should be  completed or strengthening facility monitoring of providers.  (Recommendation 5)

We provided a draft of this report to VA for comment. While VA was  reviewing a draft of this report, it requested further specificity in  recommendation two; as a result, we revised the recommendation to be  clearer. In its written comments, which are reproduced in appendix II, VA  concurred with our recommendations and provided technical comments,  which we have incorporated as appropriate.

In its comments, VA agreed that clarifying ongoing priorities and plans  and filling in gaps in implementation will help facilitate progress in its  opioid safety efforts.  VA stated that it will establish a workgroup to review  all OSI goals and ensure that the goals have clearly defined measurable  outcomes and timelines, and that documentation requirements are  established. VA also informed us that in March 2018 it published a notice  requiring VHA clinicians to conduct and document a data-based risk  review using one of VHA’s clinical decision support tools for opioid  management, such as STORM, prior to initiating opioid therapy. VA also  stated that it will take actions to ensure that academic detailing programs  are fully implemented and primary care pain champions are in place  across the system. To improve its clinicians’ adherence to opioid risk  mitigation strategies, VA stated that it will establish a workgroup to review  and develop methods for increasing adherence. VA expects to complete  all these actions by April 2019 or earlier.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of Veterans Affairs, the Undersecretary for  Health, and other interested parties. In addition, the report is available at  no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or clowersa@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix III.

Appendix I: Known Efforts and Data Related to the Veterans Health Administration’s (VHA) Opioid Safety Initiative (OSI) 2014 Goals, July 2013-December 2017

Description of known related efforts and data  According to VHA training system data, 13 of 21 VISNs  developed at least one education course addressing the  use of urine drug screening from January 1, 2015 through  April 29, 2017. Ten of the 13 VISNs developed at least  one course by the deadline (December 31, 2014) as  required. Further, 6 of the 13 VISNs had at least one  course with 30 or fewer providers completing it. Because  we found the VISN course assignment data unreliable, we  could not determine the completion rates for these  courses. However, we found that, in response to a 2015  White House memorandum that required all federal  employee opioid prescribers to complete training on the  appropriate prescribing of opioids (which included  discussion of urine drug screening) by April 15, 2017, of  20,231 prescribers who were identified and assigned the  course, 19,242 completed it, for a completion rate of  about 95 percent, according to VHA data from January 1,  2015 through April 29, 2017.

Urine drug screening targets based on  previous urine drug screening rates for  all VHA facilities must be reached by  2nd quarter, fiscal year 2015 (March 31,  2015)

According to VHA data, 151 of 157 facilities met or  exceeded their urine drug screening target by the  deadline (March 31, 2015) as required.  In addition, VHA OSI metric data also show that there has  been a 47 percentage point increase nationally in the  percentage of patients on long-term opioid therapy who  received a urine drug screen from the 4th quarter of fiscal  year 2013 to the 1st quarter of fiscal year 2018. The  increase in the percentage of patients receiving a urine  drug screening was driven more by a reduction in the total  number of patients on long-term opioid therapy rather  than an increase in the number of patients receiving the  screening.

VHA Central Office lacks certifications from all VISNs that  programs were established. Although officials at the five  VISNs in our review told us they had supported training  efforts on the use of PDMPs, only one VISN in our review  provided documentation that it had established a program  by the deadline (March 31, 2015) as required.  However, in October 2016, VHA issued a directive  requiring providers to query state PDMPs for patients  prescribed opioids and also issued guidance on how  PDMPs should be accessed and how these efforts should  be documented in VA’s electronic health record system.  In addition, according to VHA officials, querying the  PDMP was added to the 2015 White House-required  opioid safety training, as described earlier. According to  VHA data, there has been a 22 percent increase in the  querying of PDMPs by providers from 4th quarter, fiscal  year 2016 to 3rd quarter, fiscal year 2017.

Description of known related efforts and data  VHA Central Office lacks documentation from all VISNs  regarding VISN-specific protocols and implementation  plans. Only one of the five VISNs in our review provided  documentation regarding a VISN-specific protocol relating  to patients on opioids and benzodiazepines, which was  developed in 2013. Four of the five VISNs did not provide  documentation of a VISN-specific protocol or  implementation plans.  However, VHA officials told us that they addressed this  goal by issuing national tapering guidance including a  provider reference guide in 2014, an opioid taper decision  tool in 2016, and the VA/DOD clinical practice guideline in  2017. VHA officials said that the issuance of this guidance  made the VISN-required action irrelevant. In addition,  VHA OSI metric data show that there has been a 6.6  percentage point decrease nationally in the percentage of  patients dispensed an opioid and benzodiazepine from  the fourth quarter of fiscal year 2013 to the first quarter of  fiscal year 2018.

In 2016, VHA released its opioid risk stratification toolkit in  the form of an opioid safety monitoring tool called the  Stratification Tool for Opioid Risk Mitigation. In addition,  VHA updated its pain management opioid safety  education guide and quick reference guide for providers  in July 2017.

VHA-required action(s)   Each VISN must certify that the  treatment of all patients with a daily dose  of greater than 200 morphine milligram  equivalents has been reviewed by 2nd  quarter, fiscal year 2015 (March 31,  2015)

Description of known related efforts and data  VHA Central Office lacks certifications from all VISNs that  reviews were conducted. Although officials at the five  VISNs in our review told us they had completed these  reviews, only one VISN provided us with documentation  to conclude that its facilities completed their review.  However, VHA OSI metric data show that there has been  a 2.1 percentage point decrease nationally in the  percentage of patients dispensed greater than or equal to  100 morphine milligram equivalents per day from the  fourth quarter of fiscal year 2013 to the first quarter of  fiscal year 2018.

Each facility must provide evidence that  at least two evidence-based  behavioral/psychological treatments or  approved complementary or alternative  modalities can be provided by 2nd  quarter, fiscal year 2015 (March 31,  2015)

According to VHA 2nd quarter, fiscal year 2015 data, all  VHA medical facilities located in the United States  provided at least one psychosocial service and at least  one complementary and integrative health service.

In February 2016, VHA began a pilot to implement a  model of care known as the Collaborative Chronic Care  Model into existing Behavioral Health Interdisciplinary  Program teams at nine VHA medical facilities. According  to a VHA document, the pilot will provide facilitation  support to enhance existing Behavioral Health  Interdisciplinary Program teams by incorporating  evidence-based Collaborative Care Model elements,  which can include a care manager to proactively monitor  care and progress as well as other tools intended to  improve communication between primary care and  specialty care. In fiscal year 2017, efforts were expanded  to 30 additional VHA medical facilities. According to one  VHA official, the pilot is expected to be completed no  earlier than August 2019.

VISNs are regional networks that manage the VHA medical facilities located in their area. In October  2015, VHA began to implement a realignment of its VISN boundaries which resulted in the number of  its VISNs decreasing from 21 to 18.  One VISN provided evidence of one VHA medical facility’s tapering recommendations for patients on  opioids and benzodiazepines.  Based on information we obtained from VHA relative to this goal, “psychosocial” services refer to  “behavioral/psychological” treatments, and “integrated health” is a term that may be used to refer to  “complementary and alternative” modalities. According to a VHA official, the VHA facility in Manila,  the Philippines did not offer at least one psychosocial service and at least one integrative health  service for this time period.

Appendix II: Comments from the Department of Veterans Affairs

Appendix III: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Marcia A. Mann, Assistant  Director; Stella Chiang, Analyst-in-Charge; Emily Binek, Krister Friday,  Diona Martyn, and Michael Rose made key contributions to this report.  Also contributing were Zhi Boon and Emily Wilson.

The VA has been working to address opioid safety for veterans and has made progress in reducing opioid prescriptions. For example, VA has started a program to educate providers on best practices related to pain management and the optimal use of opioids.

However, we found that VA has not fully met all of its opioid safety goals. Its health care providers also are not consistently adhering to evidence-based opioid risk mitigation strategies (such as annual urine drug screenings).

We made a number of recommendations to help the VA improve opioid safety.


Veterans Affairs Contracting: Improvements in Buying Medical and Surgical Supplies Could Yield Cost Savings and Efficiency

VA spends hundreds of millions of dollars annually on medical supplies to meet the health care needs of about 7 million veterans. To provide a more efficient, cost-effective way for its medical centers to order supplies, the VA established the MSPV-NG program.

The program's goals include involving clinicians in requirements development, leveraging buying power when making competitive awards, and consolidating supplies used across medical centers. VA began developing requirements in early 2015 and launched the program in December 2016.

This testimony summarizes key information contained in GAO's November 2017 report, GAO-18-34 . Specifically, it addresses the extent to which VA's implementation of MSPV-NG has been effective in meeting program goals. GAO analyzed VA's requirements development and contracting processes, and identified key supply chain practices cited by four leading hospital networks. GAO also met with contracting and clinical officials at six medical centers, selected based on high dollar contract obligations in fiscal years 2014-2016 and geographic representation.

The Department of Veterans Affairs (VA) established the Medical Surgical Prime Vendor-Next Generation (MSPV-NG) program to provide an efficient, cost-effective way for its facilities to order supplies, but its initial implementation did not have an overarching strategy, stable leadership, and workforce capacity that could have facilitated medical center buy-in for the change. VA also developed requirements for a broad range of MSPV-NG items with limited clinical input. Further, starting in June 2015, VA planned to award competitive contracts, but instead, 79 percent of the items available for purchase under MSPV-NG were added through non-competitive agreements. (See figure).

As a result, the program did not meet the needs of medical centers, and usage remained below VA's 40 percent target. (See figure.)

VA has taken steps to address some deficiencies and is developing a new approach to the program. However, VA will likely continue to face challenges in meeting its goals until it fully addresses these existing shortcomings.

GAO made 10 recommendations in its November 2017 report, including that VA develop an overarching strategy, expand clinician input in requirements development, and establish a plan for awarding future competitive contracts. VA agreed with GAO's recommendations.

In December 2016, the Department of Veterans Affairs (VA) launched the  Medical Surgical Prime Vendor-Next Generation (MSPV-NG) program as  its primary means for purchasing supplies, such as bandages and  scalpels, for 170 VA medical centers. These supplies are intended to  meet the health care needs of about 7 million veterans. In fiscal year  2015, VA obligated $465 million for these types of supplies, and, in 2016,  it stated that it planned to achieve $150 million in cost avoidance through  a supply chain transformation effort, which includes MSPV-NG. This  transition represents a significant change to how medical and surgical  supplies are purchased, which has raised questions about whether  MSPV-NG will appropriately balance medical needs with logistical  efficiency, and whether VA can achieve its planned cost avoidance.  Effective supply chain management is an essential part of delivering  quality health care to veterans—for instance, an April 2017 interim report  issued by the VA Inspector General detailed supply management issues  at the District of Columbia VA Medical Center that posed risks to patient  care.

My remarks today are based on our recently issued report on the MSPV- NG program, and I will summarize a few key findings from that report.  Specifically, I will address the extent to which VA’s implementation of  MSPV-NG has been effective in meeting program goals.

As part of our work for our November 2017 report, we reviewed VA policy,  communications, briefings, and other documents, prior GAO reports on  best practices for organizational transformation, and internal control  standards. We interviewed Veterans Health Administration (VHA)- and  VA-wide procurement leaders, program office managers, and members of  three integrated product teams who helped develop the product  descriptions for supply items (known as requirements). We also  interviewed supply chain managers from four leading hospital networks  regarding their medical supply management practices and compared  them to those used by VA when implementing the MSPV-NG program.  To assess VA’s MSPV-NG contracting process, we analyzed the contents  of the formulary (a list of specific items that medical centers are allowed  to purchase) to determine what acquisition instrument was used to add  the items. We determined that the MSPV-NG formulary data were  sufficiently reliable by tracing data to a sample of source documents,  among other steps. We selected three VHA regional networks based on  those with the highest total contract obligations in fiscal years 2014  through 2016, geographic diversity, and other factors. We conducted site  visits to six medical centers within these three regional networks,  interviewing contracting and clinical officials. Finally, we obtained and  analyzed data on VA’s metrics for the program and determined the data  were sufficiently reliable for our purpose of measuring utilization by  interviewing officials responsible for maintaining the data and other  measures.

More detailed information on our objectives, scope, and methodology for  our work can be found in our November 9, 2017 report. We conducted  the work on which this statement is based in accordance with generally  accepted government auditing standards. Those standards require that  we plan and perform the audit to obtain sufficient, appropriate evidence to  provide a reasonable basis for our findings and conclusions based on our  audit objectives. We believe that the evidence obtained provides a  reasonable basis for our findings and conclusions based on our audit  objectives.

For over a decade, each of VA’s 170 medical centers used VHA’s legacy  MSPV program to order medical supplies, such as bandages and  scalpels. Many of those items were purchased using the Federal Supply  Schedules, which provided medical centers with a great deal of flexibility.  However, as we reported in 2016, this legacy program prevented VHA  from standardizing items used across its medical centers and affected its  ability to leverage its buying power to achieve greater cost avoidance.  Standardization is a process of narrowing the range of items purchased to  meet a given need, such as buying 10 varieties of bandages instead of  100, in order to improve buying power, simplify supply chain  management, and provide clinical consistency. In part because of the  legacy MSPV program’s limited standardization, VHA decided to  transition to a new iteration, called MSPV-NG.

The transition to MSPV-NG has been a major effort, involving the MSPV- NG program office, stakeholders from the VHA’s Procurement and  Logistics Office and VA’s Strategic Acquisition Center (SAC)—a VA-wide  contracting organization—and logistics and clinical personnel at every  medical center. The program also includes hundreds of new contracts  with individual supply vendors and a new set of prime vendor contracts to  distribute the supplies.

VA’s goals for the MSPV-NG program include (1) standardizing  requirements for supply items for greater clinical consistency; (2)  demonstrating cost avoidance by leveraging VA’s substantial buying  power when making competitive awards; (3) achieving greater efficiency  in ordering and supply chain management, including a metric of ordering  40 percent of medical centers’ supplies from the MSPV-NG formulary;  and (4) involving clinicians in requirements development to ensure  uniform clinical review of medical supplies.

VHA launched the MSPV-NG program in December 2016, but allowed a  4-month transition period. After April 2017, medical centers could no  longer use the legacy program. MSPV-NG now restricts ordering to a  narrow formulary. VHA policy requires medical centers to use MSPV- NG—as opposed to other means such as open market purchase card  transactions—when purchasing items that are available in the formulary.

Supply Chain Practices Identified by Selected Leading Hospital Networks

Leading hospital networks we spoke with have similar goals to VA in  managing their supply chains, including clinical standardization and  reduced costs. These hospital networks reported they analyze their  spending to identify items purchased most frequently, and which ones  would be the best candidates to standardize first to yield cost savings.  The hospitals’ supply chain managers reported establishing consensus  with clinicians through early and frequent collaboration, understanding  that clinician involvement is critical to the success of any effort to  standardize their medical supply chain. By following these practices,  these hospital networks have reported they have achieved significant cost  savings in some cases, and the potential for improved patient care, while  maintaining buy-in from their clinicians.

VHA’s Implementation of MSPV-NG Program Has Not Yet Achieved Its Goals

VHA’s implementation of the MSPV-NG program—from its initial work to  identify a list of supply requirements in early 2015, through its roll-out of  the formulary to medical centers in December 2016—was not executed in  line with leading practices. Specifically, VHA lacked a documented  program strategy, leadership stability, and workforce capacity for the  transition that, if in place, could have facilitated buy-in for the change  throughout the organization. Further, the initial requirements development  process and tight time frames contributed to ineffective contracting  processes. As a result, VHA developed an initial formulary that did not  meet the needs of the medical centers and has yet to achieve utilization  and cost avoidance goals. VA made some changes in the second phase  of requirements development to address deficiencies identified in the  initial roll out. Key among these was to increase the level of clinical  involvement, that is, to obtain input from the doctors and nurses at VA’s  individual medical facilities. Despite changes aimed at improving  implementation, the agency continues to face challenges that prevent the  program from fully achieving its goals.

VA’s Lack of an Overarching Strategy and Leadership Instability Were Obstacles to Effective Implementation of MSPV-NG

VA did not document a clear overall strategy for the MSPV-NG program  at the start and has not done so to date. About 6 months after our initial  requests for a strategy or plan, a VHA official provided us with an October  2015 plan focusing on the mechanics of establishing the MSPV-NG  formulary. However, this plan was used only within the VHA Procurement  and Logistics Office and had not been approved by VHA or VA  leadership. Leading practices for organizational transformation state that  agencies must have well-documented plans and strategies for major  initiatives (such as MSPV-NG) and communicate them clearly and  consistently to all involved—which included VHA headquarters, the SAC,  and all 170 medical centers. Without such a strategy, VA could not  reasonably ensure that all stakeholders understood VHA’s approach for  MSPV-NG and worked together in a coordinated manner to achieve  program goals. In our November 2017 report, we recommended that the  Director of the MSPV-NG program office should, with input from SAC,  develop, document, and communicate to stakeholders an overarching  strategy for the program, including how the program office will prioritize  categories of supplies for future phases of requirement development and  contracting. VA agreed with this recommendation and reported it would  have a strategy in place by December 2017.

Leadership instability and workforce challenges also made it difficult for  VA to execute its transition to MSPV-NG. Our work has shown that  leadership buy-in is necessary to ensure that major programs like MSPV- NG have the resources and support they need to execute their missions.  Due to a combination of budget and hiring constraints, and lack of  prioritization within VA, the MSPV-NG program office has never been fully  staffed and has experienced instability in its leadership. As of January  2017, 24 of the office’s 40 positions were filled, and program office  officials stated that this lack of staff affected their ability to implement  certain aspects of the program within the planned time frames. In  addition, since the inception of MSPV-NG, the program office has had  four directors, two of whom were acting and two of whom were fulfilling  the director position while performing other collateral duties. For instance,  one of the acting MSPV-NG program office directors was on detail from a  regional health network to fulfill the position, but had to abruptly leave and return to her prior position due to a federal hiring freeze. In our November  2017 report, we recommended that VHA prioritize the hiring of a MSPV- NG program director on a permanent basis. VA agreed with this  recommendation and indicated a vacancy announcement will be posted  by the end of 2017.

The MSPV-NG Initial Requirements Development Process Had Limited Clinician Involvement and Did Not Prioritize Categories of Supplies

The MSPV-NG program office initially developed requirements for items  to be included in the formulary based almost exclusively on prior supply  purchases, with limited clinician involvement. The program office  concluded in its October 2015 formulary plan that relying on data from  previous clinician purchases would be a good representation of medical  centers’ needs and that clinician input would not be required for  identifying which items to include in the initial formulary. Further, rather  than standardizing purchases of specific categories of supplies—such as  bandages or scalpels—program officials told us they identified medical  and surgical items on which VA had spent $16,000 or more annually and  ordered at least 12 times per year, and made those items the basis for  the formulary. Officials said this analysis initially yielded a list of about  18,000 items, which the program office further refined to about 6,000  items by removing duplicate items or those that were not considered  consumable commodities, such as medical equipment. This approach to  requirements development stood in sharp contrast to those of the leading  hospital networks we met with, which rely heavily on clinician input to help  drive the standardization process and focus on individual categories of  supplies that provide the best opportunities for cost savings.

Requirements Development and Tight Time Frames Contributed to Ineffective Contracting Practices for Initial Formulary

Based on the requirements developed by the program office, SAC began  to issue competitive solicitations for the 6,000 items on the initial  formulary in June 2015. Medical supply companies had responded to  about 30 percent of the solicitations as of January 2016. As a result,  according to SAC officials, they conducted outreach and some of these  companies responded that VHA’s requirements did not appear to be  based on clinical input and instead consisted of manufacturer-specific  requirements that favored particular products instead of broader  descriptions. Furthermore, SAC did not solicit large groups of related  items, but rather issued separate solicitations for small groups of supply  items—consisting of three or fewer items. This is contrary to industry  practices of soliciting large groups of related supplies together. Therefore,  according to SAC officials, some medical supply companies told them  that submitting responses to SAC’s solicitations required more time and  resources than they were willing to commit.

By its April 2016 deadline for having 6,000 items on the formulary, SAC  had been working on the effort for over a year and had established  competitive agreements for about 200 items, representing about 3  percent of the planned items. Without contracts for the items on the  formulary in place, VA delayed the launch of the MSPV-NG program until  December 2016 and SAC began establishing non-competitive  agreements in the last few months before the launch of MSPV-NG. As  shown in figure 1, these non-competitive agreements accounted for  approximately 79 percent of the items on the January 2017 version of the  formulary. While this approach enabled the MSPV-NG program office to  establish the formulary more quickly, it did so at the expense of one of the  primary goals of the MSPV-NG program—leveraging VA’s buying power  to obtain cost avoidance through competition.

Initial Formulary Did Not Meet Medical Center Needs, Resulting in Low Utilization of MSPV-NG and a Missed Opportunity to Leverage VA’s Large Buying Power

Once VA’s MSPV-NG initial formulary was established in December  2016, each medical center was charged with implementing it. According  to logistics officials we spoke with at selected medical centers, they had  varying levels of success due, in part, to incomplete guidance from the  program office. Without clear guidance, many medical centers reported  they were unable to find direct matches or substitutes on the MSPV-NG  formulary for a substantial number of items they routinely used, which  negatively impacted utilization rates for the initial formulary. In our  November 2017 report, we recommended that the Director of the MSPV- NG program office provide complete guidance to medical centers for  matching equivalent supply items. VA agreed with this recommendation  and indicated it would provide this guidance to medical centers by  December 2017.

According to SAC, as of June 2017, only about a third of the items on the  initial version of the formulary were being ordered in any significant  quantity by medical centers, indicating that many items on the formulary  were not those that are needed by medical centers. Senior VHA  acquisition officials attributed this mismatch to shortcomings in their initial  requirements development process as well as with VA’s purchase data.

VA had set a target that medical centers would order 40 percent of their  supplies from the MSPV-NG formulary, but utilization rates were below  this target with a nationwide average utilization rate across medical  centers of about 24 percent as of May 2017. Specifically, Chief Supply  Chain Officers—who are responsible for managing the ordering and  stocking of medical supplies at six selected medical centers—told us that  many items they needed were not included in the MSPV-NG formulary.  As such, we found that these six medical centers generally fell below  VA’s stated utilization target. As shown in figure 2, among the six selected  medical centers we reviewed, one met the target, while the remaining five  were below 25 percent utilization.

Instead of fully using MSPV-NG, the selected medical centers are  purchasing many items through other means, such as purchase cards or  new contracts awarded by their local contracting office, in part, because  they said the formulary does not meet their needs. These approaches run  counter to the goals of the MSPV-NG program and contribute to VA not  making the best use of taxpayer dollars.

Greater utilization of MSPV-NG is essential to VA achieving the cost  avoidance goal of $150 million for its supply chain transformation effort.  Under the legacy MSPV program, the National Acquisition Center tracked  cost avoidance achieved by comparing prices for competitively-awarded  MSPV supply contracts with prices available elsewhere. However, VHA  officials stated that they are not currently tracking cost avoidance related  specifically to MSPV-NG. In our November 2017 report, we  recommended that the VHA Chief Procurement and Logistics Officer, in  coordination with SAC, should calculate cost avoidance achieved by  MSPV-NG on an ongoing basis. VA agreed with this recommendation  and reported it would develop a new metric to measure cost avoidance by  June 2018.

VA Continues to Encounter Requirements Development and Contracting Challenges as It Works to Address MSPV-NG Shortcomings

In Phase 2 of MSPV-NG, the program office has taken some steps to  incorporate greater clinical involvement in subsequent requirements  development, but both its requirements development and SAC’s  contracting efforts have been hampered by staffing and schedule  constraints. In the fall of 2016, the program office began to establish  panels of clinicians to serve on MSPV-NG integrated product teams (IPT)  assigned to the task of developing updated requirements for the second  phase of the formulary. Program officials said they had difficulty recruiting  clinicians to participate. We found that slightly more than half (20 of the  38) of the IPTs had begun their work to review items and develop  updated requirements by the time the MSPV-NG program launched in  December 2016. Staff on the IPTs had to complete their responsibilities  by the end of March 2017 while simultaneously managing their regular  workload as physicians, surgeons, or nurses.

By early March 2017, the IPTs still had about 4,200 items to review.  Faced with meeting this unrealistic time frame, the MSPV-NG program  office had 9 IPT members travel to one location—with an additional 10  members participating virtually—to meet for 5 days to review the  remaining items. Members told us that this time pressure limited the  extent to which they were able to pursue the goal of standardizing  supplies, and that their review ended up being more of a data validation  exercise than a standardization review. VHA ultimately met this  compressed timeline, but in a rushed manner that limited the impact of  clinician involvement.

In our November 2017 report, we recommended that the VHA Chief  Procurement and Logistics Officer use input from national clinical  program offices to prioritize its requirements development and  standardization efforts beyond Phase 2 to focus on supply categories that  offer the best opportunity for standardization and cost avoidance. VA  agreed with this recommendation and stated it is in the process of  finalizing guidance that will detail the importance of involving the national  clinical program offices in MSPV-NG requirements development and  standardization efforts.

The SAC plans to replace the existing Phase 1 non-competitive  agreements with competitive awards based on the Phase 2 requirements  generated by the IPTs, but it may not be able to keep up with expiring  agreements due to an unrealistic schedule. Because they were made  on a non-competitive basis, the Phase 1 agreements were established for  a period of 1 year. In order to keep the full formulary available, the SAC  director said the staff must award 200 to 250 contracts before the Phase  1 agreements expire later this year. SAC officials acknowledged that it is  unlikely that they will be able to award the contracts by the time the  existing agreements expire. According to SAC officials, they are in the  process of hiring more staff to deal with the increased workload. Further,  the SAC division director told us that they canceled all outstanding Phase  2 solicitations in September 2017 due to low response rates, protests  from service-disabled veteran-owned small businesses, and changes in  overall MSPV-NG strategy.

In our November 2017 report, we recommended that the MSPV-NG  program office and SAC should establish a plan for how to mitigate the  potential risk of gaps in contract coverage while SAC is still working to  make competitive Phase 2 awards, which could include prioritizing supply  categories that are most likely to yield cost avoidance. VA agreed with  this recommendation and indicated it has developed a plan to mitigate the  risk of gaps in contract coverage with short- and mid-term procurement  strategies to ensure continued provision of medical and surgical supplies  to VHA facilities. The department also stated that it plans to replace the  current MSPV-NG contract and formulary process with a new approach  where the prime vendor would develop the formulary. However, VA will  likely face challenges in this new approach until it fully addresses the  existing shortcomings in the MSPV-NG program.

Chairman Roe, Ranking Member Walz, and Members of the Committee,  this concludes my prepared statement. I would be pleased to respond to  any questions that you may have at this time.

If you or your staff have any questions about this statement, please  contact Shelby S. Oakley at 202-512-4841 or OakleyS@gao.gov. In  addition, contact points for our Offices of Congressional Relations and  Public Affairs may be found on the last page of this statement. Individuals  who made key contributions to the report on which this testimony is based  are Lisa Gardner, Assistant Director; Emily Bond; Matthew T. Crosby;  Lorraine Ettaro; Michael Grogan; Jeff Hartnett; Katherine Lenane; Teague  Lyons; Roxanna Sun; and Colleen Taylor.

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The VA launched a new program last year, MSPV-NG, to streamline the way its medical centers buy supplies for treating 7 million vets.

As with any organizational transformation, the program's success depended on having a strong strategic plan, stable leadership, good communication, and stakeholder buy-in. But as we testified here, the VA was missing these elements when it launched the program; as a result, the program has yet to achieve key cost savings and efficiency goals.

In the report on which this testimony is based, we made 10 recommendations on how the VA can better manage future phases of the program and improve its purchasing.