VA Drug Formulary
Drug Review Process Is Standardized at the National Level, but Actions Are Needed to Ensure Timely Adjudication of Nonformulary Drug Requests Gao ID: GAO-10-776 August 31, 2010In 2009, the Department of Veterans Affairs (VA) spent nearly $4 billion on prescriptions for veterans. In general, VA provides drugs on its national formulary. However, all VA medical centers must have a nonformulary drug request process that is overseen by their regional Veterans Integrated Service Network (VISN). This report responds to a House Committee on Appropriations report directing GAO to review VA's formulary process and to an additional congressional request. Specifically, GAO reviewed (1) the process VA uses to review drugs for its national formulary, (2) the approaches VISNs and medical centers take to implementing the nonformulary drug request process, (3) the extent to which VA ensures the timely adjudication of nonformulary drug requests, and (4) the mechanisms VA has in place to obtain beneficiary input on the national formulary and make the drug review process transparent. GAO reviewed VA policy guidance and VA's pharmacy-related information technology (IT) initiatives, analyzed 2008 and 2009 drug review data and 2009 nonformulary drug request data, and interviewed VA officials from the national level, each VISN, and a judgmental sample of four medical centers.
VA uses a standardized process to review drugs for its national formulary that is coordinated at the national level by its Pharmacy Benefits Management Services (PBM). The Chief Consultant from VA's PBM told us that most drug reviews are initiated in response to FDA's approval of drugs for use on the market. To begin the process of deciding whether to include a drug on the national formulary, PBM develops evidence-based drug monographs that include information on safety, efficacy, and cost. PBM seeks comments on these monographs from VISN and medical center staff and, when appropriate, subject-matter experts. Once a monograph is complete, PBM sends it to its Medical Advisory Panel and the VISN Pharmacist Executive Committee, which review the monograph and vote on whether to add the drug to the national formulary. According to information provided by PBM, reviews for a majority of the drugs VA considered for addition to the national formulary in 2008 and 2009 were completed within a year of FDA approval, but there were a number of factors, such as safety concerns, that caused some to take longer. VISNs and medical centers vary in how they implement the nonformulary drug request process, including how they adjudicate nonformulary drug requests, collect and report required data to VA's PBM, and address appeals of denied requests. GAO found that IT enhancements could help facilitate more consistent implementation of the process. Although VA is working on replacing its pharmacy IT system, officials could not tell GAO whether components that would support the nonformulary drug request process will be implemented. VA requires that nonformulary drug requests be adjudicated within 96 hours, but it is unable to determine the total number of adjudications that exceed this standard due to limitations in the way data are collected, reported, and analyzed. While the total number of nonformulary drug request adjudications that exceed 96 hours is unknown, GAO found that data reported to VA's PBM on quarterly average adjudication times for medical centers are sufficient to demonstrate that not all requests are adjudicated within this time frame. Additionally, PBM does not have the framework in place to ensure that appeals of denied nonformulary drug requests are resolved in a timely fashion. VA obtains input from beneficiaries on the national formulary mainly through Veterans Service Organization meetings and complaints, though some VISNs have taken additional steps to seek this input. Officials from VA's PBM told GAO that they make the drug review process transparent to veterans through national formulary information available on PBM's Web site, and some VISN and medical center officials described undertaking other activities to educate beneficiaries. At the national level, VA officials are considering options for increasing beneficiary input on the national formulary and improving the transparency of the drug review process, and most VISN and medical center officials told us there could be benefit to doing so. GAO recommends that VA establish additional mechanisms to ensure nonformulary drug requests are adjudicated in a timely fashion. VA concurred with this recommendation.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: John E. Dicken Team: Government Accountability Office: Health Care Phone: (202) 512-7043GAO-10-776, VA Drug Formulary: Drug Review Process Is Standardized at the National Level, but Actions Are Needed to Ensure Timely Adjudication of Nonformulary Drug Requests
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Report to Congressional Addressees:
United States Government Accountability Office:
GAO:
August 2010:
VA Drug Formulary:
Drug Review Process Is Standardized at the National Level, but Actions
Are Needed to Ensure Timely Adjudication of Nonformulary Drug Requests:
GAO-10-776:
GAO Highlights:
Highlights of GAO-10-776, a report to congressional addressees.
Why GAO Did This Study:
In 2009, the Department of Veterans Affairs (VA) spent nearly $4
billion on prescriptions for veterans. In general, VA provides drugs
on its national formulary. However, all VA medical centers must have a
nonformulary drug request process that is overseen by their regional
Veterans Integrated Service Network (VISN). This report responds to a
House Committee on Appropriations report directing GAO to review VA‘s
formulary process and to an additional congressional request.
Specifically, GAO reviewed (1) the process VA uses to review drugs for
its national formulary, (2) the approaches VISNs and medical centers
take to implementing the nonformulary drug request process, (3) the
extent to which VA ensures the timely adjudication of nonformulary
drug requests, and (4) the mechanisms VA has in place to obtain
beneficiary input on the national formulary and make the drug review
process transparent. GAO reviewed VA policy guidance and VA‘s pharmacy-
related information technology (IT) initiatives, analyzed 2008 and
2009 drug review data and 2009 nonformulary drug request data, and
interviewed VA officials from the national level, each VISN, and a
judgmental sample of four medical centers.
What GAO Found:
VA uses a standardized process to review drugs for its national
formulary that is coordinated at the national level by its Pharmacy
Benefits Management Services (PBM). The Chief Consultant from VA‘s PBM
told us that most drug reviews are initiated in response to FDA‘s
approval of drugs for use on the market. To begin the process of
deciding whether to include a drug on the national formulary, PBM
develops evidence-based drug monographs that include information on
safety, efficacy, and cost. PBM seeks comments on these monographs
from VISN and medical center staff and, when appropriate, subject-
matter experts. Once a monograph is complete, PBM sends it to its
Medical Advisory Panel and the VISN Pharmacist Executive Committee,
which review the monograph and vote on whether to add the drug to the
national formulary. According to information provided by PBM, reviews
for a majority of the drugs VA considered for addition to the national
formulary in 2008 and 2009 were completed within a year of FDA
approval, but there were a number of factors, such as safety concerns,
that caused some to take longer.
VISNs and medical centers vary in how they implement the nonformulary
drug request process, including how they adjudicate nonformulary drug
requests, collect and report required data to VA‘s PBM, and address
appeals of denied requests. GAO found that IT enhancements could help
facilitate more consistent implementation of the process. Although VA
is working on replacing its pharmacy IT system, officials could not
tell GAO whether components that would support the nonformulary drug
request process will be implemented.
VA requires that nonformulary drug requests be adjudicated within 96
hours, but it is unable to determine the total number of adjudications
that exceed this standard due to limitations in the way data are
collected, reported, and analyzed. While the total number of
nonformulary drug request adjudications that exceed 96 hours is
unknown, GAO found that data reported to VA‘s PBM on quarterly average
adjudication times for medical centers are sufficient to demonstrate
that not all requests are adjudicated within this time frame.
Additionally, PBM does not have the framework in place to ensure that
appeals of denied nonformulary drug requests are resolved in a timely
fashion.
VA obtains input from beneficiaries on the national formulary mainly
through Veterans Service Organization meetings and complaints, though
some VISNs have taken additional steps to seek this input. Officials
from VA‘s PBM told GAO that they make the drug review process
transparent to veterans through national formulary information
available on PBM‘s Web site, and some VISN and medical center
officials described undertaking other activities to educate
beneficiaries. At the national level, VA officials are considering
options for increasing beneficiary input on the national formulary and
improving the transparency of the drug review process, and most VISN
and medical center officials told us there could be benefit to doing
so.
What GAO Recommends:
GAO recommends that VA establish additional mechanisms to ensure
nonformulary drug requests are adjudicated in a timely fashion. VA
concurred with this recommendation.
View [hyperlink, http://www.gao.gov/products/GAO-10-776] or key
components. For more information, contact John E. Dicken at (202) 512-
7114 or dickenj@gao.gov.
[End of section]
Contents:
Letter:
Background:
VA's Process for Reviewing Drugs for Its National Formulary Is
Standardized:
VISNS and Medical Centers Vary in Approaches to Implementing the
Nonformulary Drug Request Process; Technology Enhancements Could
Further Standardize the Process:
VA's Efforts to Ensure the Timely Adjudication of Nonformulary Drug
Requests Have Limitations:
VA Has Some Mechanisms to Obtain Beneficiary Input on the National
Formulary and Make Its Drug Review Process Transparent and Is
Considering Additional Steps:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Comments from the Department of Veterans Affairs:
Appendix II: GAO Contact and Staff Acknowledgments:
Table:
Table 1: Status of VA's Review of New Drugs Approved by FDA in 2008
and 2009, as of March 2010:
Figures:
Figure 1: Key VA Officials and Entities for National Formulary
Management at the National, Regional, and Local Levels:
Figure 2: VA's Drug Review Process:
Abbreviations:
CPRS: Computerized Patient Record System:
DOD: Department of Defense:
FDA: Food and Drug Administration:
IT: information technology:
MAP: Medical Advisory Panel:
OI&T: Office of Information and Technology:
PBM: Pharmacy Benefits Management Services:
PRE: Pharmacy Reengineering:
P&T: pharmacy and therapeutics:
VA: Department of Veterans Affairs:
VHA: Veterans Health Administration:
VISN: Veterans Integrated Service Network:
VistA: Veterans Health Information Systems and Technology Architecture:
VPE: VISN Pharmacist Executive:
VSO: Veterans Service Organization:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
August 31, 2010:
Congressional Addressees:
In 2009, the Department of Veterans Affairs (VA) spent nearly $4
billion on the 249 million prescriptions it dispensed to veterans,
representing about 9 percent of VA's total health care budget. In
general, medications provided through the VA pharmacy benefit must be
prescribed by a VA provider, filled through a VA pharmacy, and listed
on the Veterans Affairs National Formulary.[Footnote 1] The national
formulary is a list of drugs, grouped by class, that VA providers are
expected to use when prescribing drugs for veterans.[Footnote 2]
Providers can request access to medications not listed on the national
formulary when it is clinically necessary to do so, and all VA medical
centers are required to have a nonformulary drug request process.
[Footnote 3] Most drugs, whether on the national formulary or
nonformulary, are ordered electronically through the Veterans Health
Information Systems and Technology Architecture (VistA)--VA's health
information technology (IT) system.[Footnote 4] In 2009, 94 percent of
drugs dispensed by VA were national formulary drugs.
Until recently, drugs not listed on the national formulary might have
been available through formularies established at each of VA's 21
regional Veterans Integrated Service Networks (VISN); however,
effective January 2009, VA eliminated the use of VISN formularies,
making the national formulary the only drug formulary used by VA.
[Footnote 5] VA's Pharmacy Benefits Management Services (PBM) is the
office within the Veterans Health Administration (VHA) responsible for
administering VA's pharmacy benefit on a nationwide basis. VA's PBM
works in conjunction with the Medical Advisory Panel (MAP) and the
VISN Pharmacist Executive (VPE) Committee to manage the national
formulary, and also provides guidance for VISNs and medical centers
which are responsible for implementing the nonformulary drug request
process.[Footnote 6]
Members of Congress and interested stakeholders had questions about
whether VA's policies and practices for managing the national
formulary and processing nonformulary drug requests provide veterans
with timely access to needed medications. Additionally, they had
questions about the extent to which beneficiaries can provide input on
the national formulary and if VA's process for reviewing drugs for its
national formulary is sufficiently transparent. We conducted this work
in response to a House Committee on Appropriations report associated
with H.R. 3082, the 2010 Military Construction, Veterans Affairs, and
Related Agencies Appropriations Bill, which directed us to review and
report on VA's formulary process, and in response to a similar request
from the Chairman, Subcommittee on Health, House Committee on Veterans
Affairs.[Footnote 7] In this report, we (1) describe the process VA
uses to review drugs for its national formulary, (2) describe the
approaches VISNs and medical centers take to implementing the
nonformulary drug request process, (3) examine the extent to which VA
ensures the timely adjudication of nonformulary drug requests, and (4)
describe the mechanisms VA has in place to obtain beneficiary input on
the national formulary and make its drug review process transparent to
them.
To describe the process VA uses to review drugs for its national
formulary, we reviewed VA policy guidance, such as VA's formulary
management handbook.[Footnote 8] We obtained and summarized
information provided by VA's PBM on drug reviews VA conducted in 2008
and 2009 and identified (1) the number of reviews conducted, (2) the
outcomes of these reviews, and (3) drug review completion times. We
determined drug review completion times by calculating the amount of
time elapsed from the date PBM reported a drug as approved by the Food
and Drug Administration (FDA) to the date it reported VA completing
its review of the drug.[Footnote 9] We also obtained information from
PBM on the number of new drugs approved by FDA in 2008 and 2009 and
whether VA had completed reviews of these drugs as of March
2010.[Footnote 10] Additionally, we interviewed officials from VA at
the national, regional, and local levels. Specifically, we interviewed
national-level officials from PBM, including the Chief Consultant, and
VPEs from the 21 regional VISNs.[Footnote 11] To interview officials
at the local level, we identified a judgmental sample of four medical
centers. We selected the four medical centers to achieve variation in
the percentage of nonformulary drug prescriptions dispensed between
2006 and 2009 and variation in the total number of prescriptions
dispensed--both national formulary and nonformulary--during 2009.
[Footnote 12] We also considered geographic location. From each
medical center, we interviewed the chief of pharmacy and the physician
pharmacy and therapeutics (P&T) committee chair. Finally, we observed
a MAP meeting and interviewed some of the members.
To describe the approaches VISNs and medical centers take to
implementing the nonformulary drug request process, we reviewed VA's
formulary management handbook and interviewed officials from VA's PBM,
the 21 VPEs, and officials from our sample of four medical centers.
Additionally, we obtained documentation from VA on its pharmacy-
related health IT initiatives and interviewed officials from PBM and
VA's Office of Information and Technology (OI&T) who are responsible
for designing and implementing these initiatives. We also reviewed our
past and ongoing work on VA health IT initiatives.[Footnote 13]
To examine the extent to which VA ensures the timely adjudication of
nonformulary drug requests, we reviewed VA's formulary management
handbook for policies to use as criteria, and determined that VA
requires nonformulary drug requests to be adjudicated within 96 hours.
We interviewed officials from VA's PBM, the 21 VPEs, and officials
from our sample of four medical centers. We also obtained and analyzed
quarterly nonformulary drug request data on the average time taken to
adjudicate requests reported to PBM for calendar year 2009 at the VISN
and medical center levels. We reviewed related documentation,
interviewed knowledgeable VA officials, conducted tests for missing
data, outliers, and obvious errors, and determined that data reported
for 13 of the 21 VISNs and their medical centers were reliable for our
purposes.[Footnote 14]
To describe the mechanisms VA has in place to obtain beneficiary input
on the national formulary and make its drug review process transparent
to them, we reviewed VA's formulary management handbook as well as
reviewed the Web site for VA's PBM for the type of information
available to beneficiaries. In addition, we interviewed officials from
PBM, the 21 VPEs, and officials from our sample of four medical
centers as well as observed discussions at the MAP meeting we
attended. We also interviewed officials from the Department of Defense
(DOD) regarding its Uniform Formulary Beneficiary Advisory Panel and
attended a meeting of this group.[Footnote 15]
We conducted this performance audit from November 2009 through August
2010 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.
Background:
Formularies are used to help control pharmacy costs, enhance patient
safety, and improve quality of care by, among other things, limiting
drug choices to those a health care organization has determined are
the most medically appropriate and cost-effective for a given patient
population. As early as 1955, VA medical centers began using
formularies, and at the time, each medical center maintained its own
formulary at the local level. In September 1995, VA created a
centralized group to manage its pharmacy benefit nationwide, now
called PBM, and soon began the process of moving to a single, national
formulary. As an interim step, VA established regional formularies
operated by each VISN. On June 1, 1997, VA implemented the national
formulary to help standardize veterans' access to care across the
country, though the medical centers and VISNs continued to maintain
their own local and regional formularies. In 2001, VA abolished
medical center formularies and in 2009, VA eliminated VISN formularies.
Discussion of the elimination of the regional VISN formularies began
in 2005. In 2006, VA reviewed all drugs on VISN formularies that were
not on the national formulary to determine if these drugs should be
considered for inclusion on the national formulary. According to
officials from VA's PBM, in cases where VA decided not to add a drug
from a VISN formulary to the national formulary, VISN and medical
center staff were given 6 months to appeal the decision. In the end,
91 drugs from VISN formularies were added to the national formulary.
Around the same time that this review was taking place, VISNs were
asked to stop adding new drugs to their formularies, unless the drugs
were also being added at the national level.
While VISNs and medical centers no longer maintain their own
formularies, VA's decentralized approach to developing VistA means
that each medical center is still responsible for maintaining a local
drug file that matches VA's national drug file.[Footnote 16] In
addition to maintaining a local drug file, each medical center decides
whether and how it will customize other VistA applications onsite.
VistA contains over a hundred separate computer applications,
including the Computerized Patient Record System (CPRS). VA providers
can use CPRS to review and update patient medical records and to place
electronic orders for medications, procedures, and tests.
As part of its responsibilities for managing VA's pharmacy benefit at
the national level, VA's PBM updates the national formulary listing,
maintains databases that track drug use, and reviews data on
nonformulary drug requests that it requires each VISN to report
quarterly. PBM clinicians are responsible for maintaining a clinical
portfolio on drugs for certain diseases, and are expected to
continuously review information on new drugs that are relevant to
their portfolio, as well as stay current on information on existing
drugs. When appropriate, these clinicians will initiate a drug review.
PBM works with MAP and the VPE Committee to conduct reviews of drugs
for its national formulary, including the review of drugs approved by
FDA for use on the market.
In addition to working with VA's PBM on the national-level VPE
Committee, each VPE works in conjunction with its VISN formulary
committee at the regional level to provide oversight and guidance for
national formulary management activities for the medical centers
within the network.[Footnote 17] In turn, at the medical center level,
each chief of pharmacy works with the local P&T committee to implement
national formulary decisions and ensure compliance with these
decisions. (See figure 1.)
Figure 1: Key VA Officials and Entities for National Formulary
Management at the National, Regional, and Local Levels:
[Refer to PDF for image: entity chart]
National VA headquarters:
Top level:
Veterans Health Administration (VHA) Under Secretary for Health.
Second level, reporting to VHA Under Secretary for Health:
Pharmacy Benefits Management Services (PBM) Chief Consultant.
Third level, reporting to PBM Chief Consultant:
PBM.
Associated with PBM:
Medical Advisory Panel (MAP)/VPE Committee.
Regional Veterans Integrated Service Networks (VISNs):
Top level, associated with National VA headquarters PBM:
VISN.
Second level, reporting to VISN:
Chief Medical Officer;
VISN Pharmacist Executive (VPE).
Associated with VPE:
VISN formulary committees; these committees are also associated with
National VA headquarters, Medical Advisory Panel (MAP)/VPE Committee.
Local VA medical centers:
Top level:
Medical Center Director.
Second level, reporting to Medical Center Director:
Chief of Staff.
Third level, reporting to Chief of Staff:
Chief of Medicine:
- VA physicians;
Chief of Pharmacy:
- VA pharmacists.
Associated with Chief of Pharmacy:
Local pharmacy and therapeutics (P&T) committees; these committees are
also associated with VISN formulary committees.
Source: GAO analysis of VA documents and interviews with VA officials.
[End of figure]
Although nearly all drugs that VA providers prescribe are on the
national formulary, in some cases, providers determine that it is
clinically necessary to prescribe nonformulary drugs.[Footnote 18] VA
monitors the prescription of nonformulary drugs to ensure appropriate
use and accordingly, each VA medical center must have a nonformulary
drug request process. While VISNs and medical centers are responsible
for implementing the nonformulary drug request process, VA has
outlined certain requirements within its formulary management
handbook. The handbook states that, at the local level, each VA
medical center is responsible for establishing a process to adjudicate
nonformulary drug requests that ensures decisions are evidence-based
in accordance with certain prescribing criteria.[Footnote 19] VA also
requires that medical centers adjudicate nonformulary drug requests
within 96 hours.[Footnote 20] Each medical center chief of staff is
responsible for establishing a system to address any provider-
initiated appeals of denied nonformulary drug requests.
At the regional level, VISNs are responsible for ensuring that medical
centers have a nonformulary drug request process in place. Each VISN
is also responsible for establishing a process to analyze nonformulary
drug request data at the VISN and medical center levels to determine
if the process is implemented appropriately and effectively in medical
centers, and report these data to VA's PBM on a quarterly basis.
Reported information must include the numbers of nonformulary drug
requests received, approved, and denied as well as the average time
taken to adjudicate completed requests.
In addition to requirements for the nonformulary drug request process,
the handbook requires that VISNs ensure that local forums exist where
formulary issues can be discussed with veterans service organizations
(VSOs) on an ongoing basis.[Footnote 21] While VSO meetings may also
be held at the regional and national level, there is no requirement
that these meetings organize specifically for the purposes of
discussing formulary issues.
We previously reported on the national formulary in December 1999 and
in January 2001.[Footnote 22] We found that veterans had access to
needed medications, but VA needed to improve its oversight activities.
In our 2001 report, we recommended that VA take steps to better ensure
that VISNs and medical centers comply with the national formulary and
nonformulary drug request policies and procedures. VA responded to
these recommendations by, among other things, having its PBM check
drug utilization data--which tracks drugs dispensed across VA--for
outliers and requiring that nonformulary drug requests be adjudicated
within 96 hours.
VA's Process for Reviewing Drugs for Its National Formulary Is
Standardized:
VA uses a standardized process to review drugs for its national
formulary that is coordinated at the national level by its PBM. PBM's
Chief Consultant told us that most reviews are initiated in response
to FDA's approval of drugs for use on the market. To begin reviewing a
drug for inclusion on the national formulary, clinicians from PBM
develop evidence-based drug monographs that include information on
safety, efficacy, and cost, and seek comments on these monographs from
VISN and medical center staff. Completed monographs are then reviewed
by MAP and the VPE Committee, who vote on whether to add the drug to
the national formulary. A majority of the drugs VA considered for
addition to the national formulary in 2008 and 2009 were reviewed
within one year of FDA approval, but there were various factors that
caused some reviews to take longer.
VA's PBM Initiates Most Drug Reviews in Response to FDA Approval of
Drugs:
VA's drug review process is coordinated at the national level by its
PBM, whose Chief Consultant told us that most reviews are initiated
following FDA's approval of a drug for use on the market to determine
whether to add the drug to the national formulary.[Footnote 23] While
there are different types of FDA approvals, PBM's Chief Consultant
said that most drug reviews are triggered by FDA approval of a new
drug.[Footnote 24] PBM also initiates drug reviews to consider whether
to remove a drug from the national formulary, such as in response to
the emergence of new safety issues. Additionally, PBM officials said
that they may decide to conduct a drug class review to determine
whether there is superiority of one or more drugs in a class, or if
the drugs are equivalent in terms of safety and efficacy. Such reviews
are undertaken when VA is considering negotiating a drug contract or
to determine a drug's place in therapy relative to other drugs in its
class.[Footnote 25]
According to VA officials, medical center staff can submit requests to
their local P&T committees to review a drug for addition to or removal
from the national formulary.[Footnote 26] P&T committees review and
forward approved requests to their regional VISN formulary committees.
If VISN formulary committees review and approve requests, they forward
them to VA's PBM for consideration at the national level.[Footnote 27]
In 2009, VISNs submitted 13 requests for drug reviews, and while 2 of
the requests were later withdrawn, PBM approved all of the requests
for national review.
VA Uses Evidence-Based Drug Reviews and Relies on Internal
Stakeholders to Select Drugs for Its National Formulary:
VA uses a standardized process to review drugs for inclusion on its
national formulary, which begins with a clinician from its PBM
researching relevant literature to develop an evidence-based drug
monograph. Each drug monograph includes the clinician's research
methodology, safety and efficacy tables, and data on cost.[Footnote
28] Further, the clinician may consult with VA subject matter experts
to assist with the development of monographs when necessary. Once a
draft of a monograph is ready, the clinician forwards it to the VPEs
and requests that the document be disseminated to VISN and medical
center staff, including physicians and pharmacists, for comment.
Generally, within a period of 2 to 4 weeks, comments about the
monograph are returned to the PBM clinician. The clinician compiles
and reviews these comments, and incorporates any changes deemed
appropriate to the monograph.[Footnote 29]
Once VA's PBM has completed a drug monograph, MAP and the VPE
Committee review PBM's findings and vote whether to add the drug to
the national formulary based on an assessment of the drug's safety,
efficacy, and cost as well as its relevance to the veteran population.
[Footnote 30] While most members of MAP and the VPE Committee are VA
staff, a clinical representative from DOD participates in the MAP and
VPE Committee meetings and votes on MAP decisions.[Footnote 31] A
number of MAP and VPE Committee members we interviewed told us that
they consider a drug's safety and efficacy before they consider cost
when reviewing a monograph. Most members also said that the two groups
typically agree on national formulary decisions, but that when
disagreements occur, they usually stem from operational issues, such
as establishing process guidelines for ordering a drug within VA. In
the event of a disagreement, VA's policy is that final decisions rest
with MAP.
MAP and the VPE Committee may also recommend that restrictions or
criteria for use be developed to better ensure a drug's appropriate
use.[Footnote 32] Criteria for use are reviewed by MAP and the VPE
Committee and then sent to VISN and medical center staff for comment.
Once comments are received, members vote to approve the final
document. Officials from VA's PBM told us that MAP and the VPE
Committee are also authorized to classify a drug as "no buy" for
purposes of prohibiting its use in cases where there are serious
safety concerns in a population similar to the VA population. However,
as of April 2010, there were no drugs on the national "no-buy" list.
In addition, PBM has developed national guidance to improve the safety
of "off-label" prescribing, which occurs when providers prescribe
drugs for indications other than those FDA has approved. While PBM
authorizes its providers to prescribe drugs "off-label," it recommends
that providers use an evidence-based approach and follow protocols
established by their local P&T committee.[Footnote 33] Figure 2
illustrates VA's drug review process.
Figure 2: VA's Drug Review Process:
[Refer to PDF for image: process map]
Review:
Clinicians from VA‘s Pharmacy Benefits Management Services (PBM)
research relevant literature to develop an evidence-based drug
monograph. VA subject matter experts offer comments, as appropriate.
Pharmacist executives from each Veterans Integrated Service Network
(VISN) receive the monograph and disseminate it to VISN and medical
center staff, including physicians and pharmacists. VISN and medical
center staff offer comments.
Clinicians from PBM compile and review comments, and incorporate any
changes deemed necessary.
The Medical Advisory Panel (MAP) and the VISN Pharmacist Executive
(VPE) Committee review the monograph and vote on the drug.
Decision outcomes:
1) Drug is included on the national formulary:
* Restrictions or criteria for use are developed to better ensure a
drug‘s appropriate use; or:
* Restrictions or criteria for use are not necessary.
2) Drug is made nonformulary:
* Restrictions or criteria for use are developed to better ensure a
drug‘s appropriate use; or:
* Restrictions or criteria for use are not necessary.
3) Drug is designated ’no buy“ to prohibit unsafe use.
Source: GAO analysis of VA documents and interviews with VA officials.
[End of figure]
After MAP and the VPE Committee make national formulary decisions,
VA's PBM updates the national drug file. VISN formulary committees
communicate national formulary decisions to medical center P&T
committees. P&T committees subsequently inform medical center staff of
these decisions. Pharmacy IT staff at each medical center update the
local drug file by matching the local drug file to the drug's code at
the national level. PBM officials we interviewed stated that it is
more difficult for some medical centers to update local drug files
than others, generally due to IT staffing resources.[Footnote 34]
In 2008 and 2009, VA considered 61 drugs for inclusion on the national
formulary. Of those, MAP and the VPE Committee voted to add 11 drugs
to the national formulary and to approve 50 drugs for nonformulary
use. In addition, MAP and the VPE Committee voted to add either
restrictions or criteria for use to 25 of these drugs to ensure they
were used appropriately. According to officials from VA's PBM, MAP and
the VPE Committee made the 50 drugs nonformulary for reasons including
(1) they determined the drug under review offered no significant
benefit over national formulary alternatives already available, (2)
they determined that the drug would have limited use for the veteran
population, or (3) they had concerns about ensuring the drug's safe
and appropriate use, and therefore required prospective review.
Drug Review Times Vary:
The time it takes VA to review a drug varies and is primarily
determined by whether there are factors that complicate the drug
review process, such as safety concerns, and the drug's priority
status. Of the 61 drugs that VA considered for addition to the
national formulary during 2008 and 2009, information provided by VA's
PBM indicates that 35 reviews were concluded within one year of the
time FDA approved the drug and an additional 17 reviews were completed
within 2 years of FDA approval. The remaining 9 reviews were completed
more than 2 years after the FDA approval, with 4 of these reviews
taking 3 to 5 years to complete. PBM officials reported a number of
reasons why some of these reviews took longer than others. In some
cases, safety concerns necessitated the development of criteria for
use, which delayed the drug review process. For example, one drug,
approved by FDA for the treatment of a rare blood disease, was
determined to potentially increase a patient's risk of infection and
took VA 18 months to review. Officials said that developing criteria
for use increased review time because the criteria were complicated
and required consultation with a hematologist. In other cases, reviews
were delayed because there was a lack of reputable information, such
as studies published in peer-reviewed journals. Additionally, drug
reviews took longer when alternative drugs were already available on
the national formulary and PBM decided to conduct a drug class review.
PBM officials told us that drug class reviews can take twice as long
as the review of an individual drug because they involve compiling
information on multiple drugs.
Officials from VA's PBM told us they experience a backlog of drugs to
review because there are always more potential reviews than they can
accommodate, and thus, they review high-priority drugs first.[Footnote
35] Additionally, the officials said they have implemented strategies
to alleviate the drug review workload, such as soliciting assistance
from VISN and medical center staff to prepare and present drug
monographs, and conducting abbreviated drug reviews when appropriate.
[Footnote 36] Some VPEs we spoke with said that they can talk to PBM
clinicians about moving a drug up on the priority list if necessary.
In addition to the 61 drugs VA considered for addition to the national
formulary in 2008 and 2009, we examined new drugs approved by FDA in
2008 and 2009, and the progress VA made in reviewing them. (See table
1.) According to information provided by VA's PBM, of the 52 new drugs
FDA approved for use on the market in 2008 and 2009, VA either
reviewed, or was in the process of reviewing, 38 of them as of March
2010.[Footnote 37] Reviews of the remaining 14 drugs were pending,
since VA categorized these drugs as a lower priority for reasons such
as there being a viable alternative drug on the national formulary or
the drug having limited use for the veteran population.
Table 1: Status of VA's Review of New Drugs Approved by FDA in 2008
and 2009, as of March 2010:
Review complete:
Approved in 2008: 9;
Approved in 2009: 7;
Total: 16.
Review in progress:
Approved in 2008: 8;
Approved in 2009: 14;
Total: 22.
Review pending:
Approved in 2008: 7;
Approved in 2009: 7;
Total: 14.
Total:
Approved in 2008: 24;
Approved in 2009: 28;
Total: 52.
Source: GAO summary of information provided by VA's PBM.
[End of table]
Although drug review times vary, if providers determine that it is
clinically necessary, veterans may be able to access a drug before a
national review is complete. Officials from VA's PBM told us that, due
to the length of time it takes for PBM to conduct a drug review, VISNs
and medical centers may develop interim guidance for reviewing and
approving nonformulary requests for a drug not yet reviewed at the
national level. The officials said that the VISN or medical center
creating interim guidance could develop drug monographs and criteria
for use for the purpose of evaluating nonformulary drug requests. PBM
officials also said that they neither encouraged nor discouraged this
practice, and think it is common among VISNs and medical centers.
Officials from one medical center we interviewed told us that they
conduct reviews of drugs that have not yet been reviewed at the
national level, and that if they approve a drug for nonformulary use,
they typically develop local restrictions or criteria for use until
national guidance is issued. Officials from another medical center
stated that they would not decide whether to permit nonformulary use
of drugs that have not been reviewed by MAP and the VPE Committee, but
noted that if a veteran urgently needed one of these medications, they
would forward the request to the VISN.
VISNS and Medical Centers Vary in Approaches to Implementing the
Nonformulary Drug Request Process; Technology Enhancements Could
Further Standardize the Process:
VISNs and medical centers vary in approaches to implementing the
nonformulary drug request process, including how they adjudicate
nonformulary drug requests, collect and report required data to VA's
PBM, and address appeals of denied requests. We found that IT
enhancements could help facilitate more consistent implementation of
the process. Although VA intends to replace its pharmacy IT system, it
is uncertain whether changes that would support the nonformulary drug
request process will be implemented.
Processes for Adjudicating Nonformulary Drug Requests, Collecting and
Reporting Required Data, and Addressing Appeals Vary:
The process for adjudicating nonformulary drug requests varies among
medical centers, in part due to differences in local IT resources.
Most medical centers use CPRS to electronically process nonformulary
drug requests, though providers can also make requests outside of the
system either through submitting paper-based requests or contacting
adjudicating officials directly to verbally request nonformulary
drugs.[Footnote 38] Further, the extent to which medical centers can
automate CPRS depends on the availability of onsite IT expertise. Some
medical centers, for example, are able to create drug-specific order
templates in CPRS for nonformulary drugs. Officials from VA's PBM told
us that these templates are interactive and prompt providers through
criteria checks to ensure appropriate use. If criteria are met, the
drug is automatically submitted for ordering. Although this method
further automates the nonformulary drug request process and better
ensures that information about the drug is easily accessible to
providers, some VPEs told us that it can be challenging from an IT
perspective and that not all medical centers have the IT resources
needed to create order templates. One VPE told us that the VISN has
created order templates so that medical centers with more limited IT
resources can use them, and another VPE said that the VISN would like
to do this.
While some medical centers are able to create drug-specific order
templates, most VPEs and medical center officials whom we interviewed
told us that CPRS is used to create electronic nonformulary drug
request forms, which providers submit to a pharmacist for
adjudication.[Footnote 39] The format of these request forms can vary.
For example, some may be used just for nonformulary drug requests,
while others may be used more broadly to request both national
formulary drugs that have restrictions and nonformulary drugs.
Additionally, some nonformulary drug request forms may be populated
with drug-specific information, while others require providers to fill-
in information for requested drugs. Officials from two of the four
medical centers whom we interviewed cited challenges with using
nonformulary drug request forms. For example, officials from one
medical center told us that due to the way the nonformulary drug
request form is designed, providers may not realize how to access
information needed to justify their requests and subsequently have
them denied.
VISNs vary in the processes they use to collect required nonformulary
drug request data and report these data at the VISN and medical center
levels to VA's PBM on a quarterly basis. VPEs from 18 of the 21 VISNs
told us they collect required data--which include the numbers of
nonformulary drug requests received, approved, and denied, as well as
the average time taken to adjudicate completed requests--from their
medical centers and report them to PBM, while 3 VPEs said that they
instruct medical centers to report nonformulary drug request data
directly to PBM. VPEs from the 18 VISNs obtain nonformulary drug
request data in a variety of ways, such as extracting data from shared
databases, or requiring medical center staff to complete spreadsheets
or input data into an internal VISN Web site.
Medical centers have established different processes for addressing
provider-initiated appeals of denied nonformulary drug requests, and
one VISN has centralized the appeals process.[Footnote 40] The VPEs we
interviewed stated that medical centers rely on different personnel to
adjudicate appeals of denied nonformulary drug requests, such as the
chief of staff, the chief of pharmacy, the P&T committee chair, or the
entire P&T committee. Furthermore, the appeals process may involve
several layers of review. For example, officials from one medical
center explained that appeals are first routed to a pharmacy
supervisor. If the pharmacy supervisor also denies the nonformulary
drug request, it is forwarded to the chief of medicine for review. If
the chief of medicine denies the request, the provider can make a
final appeal to the chief of staff. Some VPEs also said that VISN
chief medical officers and formulary committees may become involved in
adjudicating appeals at the regional level.
Technology Enhancements That Could Further Standardize the
Nonformulary Drug Request Process Have Been Considered, but
Implementation Is Not Planned:
Based on interviews with VA officials, we found that IT improvements
could facilitate more consistent implementation of the nonformulary
drug request process among VISNs and medical centers, and some of
these capabilities were included in the original scope of VA's
Pharmacy Reengineering (PRE) project.[Footnote 41] Since 2001, VA has
been working on PRE with the intention of improving pharmacy
operations, customer service, and patient safety by replacing current
pharmacy software with new technology.[Footnote 42] At the national
level, VA's Office of Information and Technology is responsible for
planning, executing, and providing oversight for PRE--which includes
allocating resources to the project--while its PBM is responsible for
developing and prioritizing PRE requirements.[Footnote 43] PBM
officials told us that PRE was expected to make adjudicating
nonformulary drug requests and to make collecting and reporting
related data easier and more standard systemwide. For example, PBM's
Chief Consultant said that with enhanced software, providers at all VA
medical centers would be prompted to complete a series of criteria
checks when requesting a nonformulary drug, and if met, the request
would be automatically approved.[Footnote 44] PBM officials also
stated that PRE would help improve data collection and reporting
related to nonformulary drug requests if it is implemented as
intended.[Footnote 45] VPEs from 15 of the 21 VISNs we spoke with
stated that improvements could be made to VA's pharmacy IT system, and
most cited various benefits that improvements could provide, such as
better ensuring that prescribing criteria are adhered to and enhancing
the ability to collect and report nonformulary drug request data.
However, VA has recently restructured the PRE project and has not
established plans for delivering all originally proposed capabilities.
In July 2009, the department suspended IT projects--including PRE--
that had either fallen behind schedule or gone over budget.[Footnote
46] Subsequently, the department instituted a new IT project
management approach that, among other things, requires projects to
plan and deliver releases of new IT functions in increments of up to 6
months.[Footnote 47] In October 2009, VA restarted PRE with plans for
an initial set of four increments and has since identified two
additional increments, for a total of six increments. According to
officials from VA's OI&T and PBM, the six increments reflect an effort
to meet the department's highest priority pharmacy reengineering needs
while delivering new IT functions more frequently.[Footnote 48]
However, capabilities that directly support the nonformulary drug
request process and related data collection and reporting are not
included in these increments, and as of May 2010, future increments
had not been planned. Furthermore, VA's development and implementation
of future increments could be impacted by delays the project is
experiencing with the first six increments. Specifically, while
increment four was scheduled to be implemented by June 2010, in August
2010 officials said that they intended to implement this increment by
the end of the month. Officials also told us that increments five and
six may not meet their estimated implementation date of December
2010.[Footnote 49] As a result, the extent to which PRE will help
standardize the nonformulary drug request process, as the project was
originally envisioned, is uncertain.
VA's Efforts to Ensure the Timely Adjudication of Nonformulary Drug
Requests Have Limitations:
Per VA policy, nonformulary drug requests must be adjudicated within
96 hours; however, VA is unable to determine the total number of
adjudications that exceed this standard due to limitations in the way
data are collected, reported, and analyzed. While the total number of
nonformulary drug request adjudications that exceed 96 hours is
unknown, we found that data reported to VA's PBM on quarterly average
adjudication times for medical centers are sufficient to demonstrate
that not all requests are adjudicated within this time frame.
Additionally, PBM has limited oversight of the timeliness of appeals
of denied nonformulary drug requests.
VA Is Unable to Determine the Total Number of Nonformulary Drug
Request Adjudications That Exceed Its 96-Hour Standard, but Reported
Data Are Sufficient to Demonstrate That Not All Are Completed within
This Time Frame:
VA policy requires that nonformulary drug requests be adjudicated
within 96 hours, but it is unable to determine the total number of
adjudications that exceed this standard due to limitations in the way
data are collected, reported, and analyzed. As previously noted, VISNs
are required to report nonformulary drug request average adjudication
times at the VISN and medical center levels to VA's PBM on a quarterly
basis. VA's decision to limit data collection and analysis of the
timeliness of nonformulary drug request adjudications to average
adjudication times has oversight implications compared to collecting
and analyzing data on individual requests. First, without collecting
and analyzing request-level data, the total number of adjudications
that exceed 96 hours is unknown systemwide. Second, averages can be
strongly influenced by the presence of a few extreme values, or
outliers, and may not give an accurate view of the typical
adjudication times at medical centers.[Footnote 50]
Additionally, inconsistencies in the way nonformulary drug request
data are collected and reported across VA means that data reported for
some VISNs and their medical centers may not be entirely accurate or
complete. VPEs for 8 of the 21 VISNs told us that medical centers in
their regions may include requests for restricted national formulary
drugs in the nonformulary drug request data that they report to VA's
PBM.[Footnote 51] If quarterly average adjudication times were to
exceed 96 hours at medical centers within these VISNs, it would not be
possible to determine whether this was the result of requests for
restricted national formulary drugs or requests for nonformulary
drugs. PBM officials said that they were not aware of this practice
and would remind VPEs that only requests for nonformulary drugs are to
be reported. Also, VISNs and medical centers determine how they will
collect and report data on nonformulary drug requests made through
paper-based forms and direct verbal communications with adjudicators,
and some medical centers may not include these types of requests in
reported data. Specifically, officials whom we interviewed from one
medical center told us that only requests for 26 nonformulary drugs
are made through CPRS and reported to PBM, while other nonformulary
drug requests are made through direct communications with adjudicators
to manage workloads. The VPE for this medical center said that steps
are being taken to ensure that it includes all nonformulary drug
requests in the data it reports. Finally, six medical centers did not
report nonformulary drug request data for every quarter in 2009. PBM
officials told us they were not aware of this issue and would ensure
that VPEs check that all medical centers report data.
While VA is unable to determine the total number of nonformulary drug
request adjudications that exceed 96 hours, we found that data
reported to VA's PBM on quarterly average adjudication times for
medical centers are sufficient to demonstrate that not all requests
are adjudicated within this time frame.[Footnote 52] To conduct our
review of the data reported to PBM, we limited our analysis to the 13
VISNs and their medical centers where VPEs told us that requests for
restricted national formulary drugs are not included in reported
nonformulary drug request data. Therefore, even though reported data
for these VISNs and medical centers may be incomplete due to, for
example, missing paper-based and verbal requests, the data are
sufficiently reliable to show that at least some nonformulary drug
requests are not being adjudicated within VA's 96-hour standard.
Specifically, we found that during 2009, 7 of these VISNs each had one
or more medical centers that took longer than 96 hours--on average--to
adjudicate nonformulary drug requests in a given quarter.[Footnote 53]
Quarterly average adjudication times that exceeded 96 hours within the
7 VISNs ranged from just over 97 hours at one medical center to 240
hours at another medical center.[Footnote 54]
Officials from VA's PBM told us that they analyze nonformulary drug
request data aggregated at the VISN level to monitor the timeliness of
adjudications; however, this approach may not alert them to
adjudication problems occurring at medical centers. PBM officials
stated that VISNs and medical centers are primarily responsible for
ensuring compliance with nonformulary drug request policies; thus,
while medical center-level nonformulary drug request data are
collected and reported to PBM, it analyzes data aggregated at the VISN
level to ensure timely adjudications and expects VISNs and medical
centers to monitor medical center-level data. PBM officials told us
that they would follow-up with VISNs if aggregated data showed an
average adjudication time that was greater than 96 hours. However,
while at least 7 VISNs had medical centers with reported quarterly
average adjudication over 96 hours in 2009, none of the VISN-level
averages exceeded VA's standard.
VA's PBM Has Limited Oversight of the Timeliness of Appeals of Denied
Nonformulary Drug Requests:
At the national level, VA's PBM does not have the framework in place
to ensure that appeals of denied nonformulary drug requests are
resolved in a timely fashion. While PBM officials told us that they
expect nonformulary drug request appeals to be adjudicated in a timely
manner, they have not established a time frame in policy. Most VPEs
also told us that they expect appeals to be adjudicated in a timely
manner, and some stated that the 96-hour nonformulary drug request
adjudication threshold also applies to appeals. However, we found that
not all appeals processes may be structured to produce timely results.
For example, officials from one medical center told us that the local
P&T committee adjudicates appeals for nonformulary drugs that are not
urgently needed. However, one official noted that appeals that go to
the P&T committee can take a month or more to resolve as they are
dependent on the P&T committee's meeting schedule. Other VPEs also
stated that the medical centers in their regions may require P&T
committees to adjudicate appeals.
Furthermore, VA's PBM does not require VISNs and medical centers to
collect and analyze data on the nonformulary drug request appeals
process; therefore, the number of appeals, outcomes, and adjudication
times are unknown systemwide. Of the 21 VISNs, only one VPE reported
that the VISN collects and analyzes data on nonformulary drug request
appeals.[Footnote 55] Some VPEs told us that medical centers may track
nonformulary drug request appeals data. However, officials from three
of the medical centers whom we interviewed told us that their sites do
not collect such data, with an official from one noting that this is
because the medical center has yet to receive any appeals. An official
from the fourth medical center whom we interviewed said that appeals
are published in P&T committee meeting notes, but that the medical
center does not aggregate these data.
VA Has Some Mechanisms to Obtain Beneficiary Input on the National
Formulary and Make Its Drug Review Process Transparent and Is
Considering Additional Steps:
VA obtains beneficiary input on the national formulary mainly through
VSO meetings and complaints, though some VISNs have taken additional
steps to seek this input. Officials from VA's PBM told us that they
make the drug review process transparent to veterans through online
information about the national formulary, and some VPEs and medical
center officials described undertaking other activities to educate
beneficiaries. At the national level, VA officials are considering
options for increasing beneficiary input on the national formulary and
improving the transparency of the drug review process, and most VPEs
and medical center officials told us there could be benefit to doing
so.
VA Obtains Beneficiary Input on the National Formulary Mainly through
VSO Meetings and Complaints:
VA officials told us that they may obtain beneficiary input on the
national formulary through VSO meetings; although the extent to which
pharmacy staff attend these meetings varies among VISNs and medical
centers, and officials said that national formulary issues are not
frequently discussed. All VPEs told us that medical centers in their
regions hold local VSO meetings, and many said that there are VSO
meetings held at the regional level as well. However, 3 of the 21 VPEs
said that they or a VISN-level pharmacy representative regularly
attend VSO meetings either at the regional or local level. Eleven VPEs
said that they sometimes attend these meetings, and 7 said that they
do not attend, but noted that pharmacy staff at medical centers may
attend the meetings.[Footnote 56] Of the medical center chiefs of
pharmacy we interviewed, one attends VSO meetings at the medical
center regularly, two attend if invited, and one does not currently
attend these meetings.
While officials from most VISNs and medical centers whom we
interviewed told us that pharmacy benefits are discussed during VSO
meetings, many also said that issues related to the national formulary
are not often raised. Rather, they stated that pharmacy benefit
concerns tend to focus on operational issues, such as copayments and
ordering medication refills. A few VPEs noted that when questions
about the national formulary are raised during VSO meetings, they are
usually patient-specific and addressed outside of the meetings.
At the national level, the Chief Consultant from VA's PBM said that,
as necessary, he discusses national formulary issues at VSO meetings
held by VA's Under Secretary for Health on a quarterly basis; however,
the Chief Consultant has only attended one of these meetings in the
past 6 years. He said that he also receives occasional questions from
VSO representatives about the national formulary.
Outside of VSO meetings, most VPEs and medical center officials said
that VA obtains beneficiary input on the national formulary through
complaints by veterans or those acting on their behalf, such as
providers, patient advocates, or members of Congress.[Footnote 57]
Almost all VPEs noted that, at the regional level, they do not receive
many complaints related to the national formulary and that most
complaints are handled locally. Officials from three of the four
medical centers we spoke with discussed receiving complaints on the
national formulary. For example, an official from one medical center
said that the medical center receives complaints from patients who
transferred to VA from the private sector and want to stay on a
medication that is not on VA's national formulary.
Officials from VA's PBM told us that, at the national level, they
occasionally receive complaints about the national formulary, but they
do not routinely monitor beneficiary input in a centralized way. For
example, while patient advocates are required to collect data on
veteran complaints at medical centers, PBM officials reported that
they do not have information on these or other local complaints. PBM
officials also told us that while VA's Office of Quality and
Performance administers the Survey of Healthcare Experiences of
Patients, this survey is limited in scope and they do not use it to
obtain beneficiary input on the national formulary. PBM officials
reported that they are not aware of other surveys conducted for this
purpose.
Some VISNs have taken additional steps to seek beneficiary input on
the national formulary. For example, one VPE whom we interviewed
conducts site visits at medical centers in the region and talks to
beneficiaries about national formulary issues during these visits.
Another VPE said that the VISN recently added a 2-hour session at the
end of its Executive Leadership Council meetings for beneficiaries to
attend and discuss concerns. The VPE said that so far pharmacy benefit
concerns have been raised at every meeting, including concerns about
access to national formulary and nonformulary drugs. A VPE from a
third VISN said that the region tried adding comment cards for
pharmacy suggestions, but that they did not receive many suggestions.
VA's PBM Provides National Formulary Information on Its Web Site, and
Some VISNs and Medical Centers Engage in Other Activities to Educate
Beneficiaries about the Drug Review Process:
Officials from VA's PBM told us that they make the drug review process
transparent to beneficiaries through national formulary information
that is available online. Our review of PBM's Web site found that PBM
posts the national formulary listing via an Excel spreadsheet, with a
separate spreadsheet that highlights formulary changes. In addition,
PBM provides a link to its Ez-Minutes newsletter, which is accessible
online or through an e-mail subscription. Ez-Minutes provides a
listing of national formulary decisions, but does not provide context
for these decisions, such as when a drug is made nonformulary due to
safety concerns.[Footnote 58] PBM also posts documents related to the
drug review process on its Web site, such as drug monographs and
criteria for use documents. Finally, the Web site provides answers to
frequently asked questions about the national formulary.
In addition to the information provided by VA's PBM, some VPEs and
medical center officials described undertaking other activities to
educate beneficiaries on VA's drug review process at the regional and
local levels. For example, one VPE whom we interviewed said that the
VISN had begun a new program called, "Formulary Awareness: Veterans
Helping Veterans." The VPE told us that this program has a number of
components including recruiting individuals to be in waiting rooms and
wear buttons that say "Ask! Is your medication on formulary?" and
providing brochures, pens, and tent cards at medical centers with
information that includes a national formulary fact of the month.
Another VPE said that the VISN sends a newsletter to veterans in its
region that includes a section on how the national formulary works,
points veterans to PBM's Web site, and provides pharmacist contact
information if veterans have any questions. Likewise, one medical
center official whom we interviewed posts explanations about why VA
has a national formulary on the bulletin boards in pharmacy waiting
room areas. Also, officials from three of the medical centers whom we
interviewed noted that they send letters to beneficiaries when
national formulary changes impact them, and officials from the fourth
medical center said that they ask providers to inform veterans of
these changes.
VA Officials Are Considering Options for Increasing Beneficiary Input
and Improving the Transparency of the Drug Review Process:
At the national level, VA officials are considering options for
increasing beneficiary input on the national formulary and improving
the transparency of the drug review process. Options were discussed
during a MAP meeting in January 2010, and while no formal decision was
made, the overall consensus was to try to work within existing lines
of communication. Following this meeting, officials from VA's PBM told
us that MAP and the VPE Committee were in discussions to develop a
process whereby veteran input at local VSO meetings could be reported
and addressed nationally. The officials said that they would like to
use local VSO meetings as a mechanism for obtaining input, because it
would be easier for veterans to travel to meetings in their local area
and these meetings may allow for input on not only national formulary
issues, but also other pharmacy benefit issues that may be local in
scope. In June 2010, options were again discussed during a meeting of
MAP and the VPE Committee. PBM's chief consultant told us that a final
decision was not made during this meeting, but that the next step is
to discuss the issue with VHA management.
Officials from most VISNs and medical centers we interviewed told us
that there could be benefit to increasing beneficiary input on the
national formulary or improving the transparency of VA's drug review
process, and a number gave suggestions for doing so. For example, one
medical center official said that the Ez-Minutes newsletter contains
technical language and that it would be beneficial for VA's PBM to
create something that was easier for beneficiaries and their
representatives to understand. Likewise, a VPE suggested that national
formulary changes be sent to local VSOs along with non-technical
explanations of the reasons for the changes. Another VPE said that one
way to better obtain beneficiary input on the national formulary would
be to survey patients through an independent organization.
While VA officials are considering options for increasing beneficiary
input on the national formulary and improving the transparency of the
drug review process, they have concerns about formally involving
beneficiaries or their representatives in national formulary
decisions. Specifically, this matter was raised during the January MAP
meeting around a discussion about DOD's Uniform Formulary Beneficiary
Advisory Panel.[Footnote 59] During our interviews, VPEs and medical
center officials also raised concerns about this issue. Their concerns
included that lay people may not have the technical knowledge to make
evidence-based decisions, and that they could be unduly influenced by
direct to consumer advertising from pharmaceutical companies.
Officials were also concerned that another layer of review would slow
down the drug review process. We spoke with DOD officials about the
Uniform Formulary Beneficiary Advisory Panel, and they said that
although the panel's input on DOD's formulary decisions is limited, it
has provided useful feedback on how to operationalize formulary
decisions, and resulted in DOD communicating formulary decisions in
less technical terms to beneficiaries.
Conclusions:
In 2009, VA provided millions of prescriptions to veterans through its
pharmacy benefit. While VA's process for reviewing drugs to decide
whether they should be included on its national formulary is overseen
by its PBM, VISNs and medical centers are responsible for implementing
the nonformulary drug request process, and there is variation in the
approaches that VISNs and medical centers take. For example, some
VISNs and medical centers have more automated approaches to
adjudicating nonformulary drug requests and collecting and reporting
required data than others. In response to recommendations we made in
our 2001 report, VA established a requirement for routine nonformulary
drug requests to be adjudicated within 96 hours. However, some
adjudications continue to surpass this threshold, and data reported to
monitor timeliness are not always accurate or complete for all VISNs
and their medical centers. Additionally, reported data are only
required to include average adjudication times for nonformulary drug
requests, which do not capture the total number of adjudications that
fall outside VA's 96-hour standard. Finally, VA does not require that
appeals of denied nonformulary drug requests are resolved within a
certain time frame or that the outcomes of appeals are tracked. Given
these limitations, additional steps are needed to ensure that veterans
receive clinically necessary nonformulary drugs in a timely manner.
VA is in the process of making changes to its pharmacy IT system
through its PRE project, which could help facilitate more consistent
implementation of the nonformulary drug request process among VISNs
and medical centers. We previously reported on delays and challenges
VA has faced implementing PRE, and it remains unclear when PRE will be
complete. If PRE does not move forward, VA will continue to rely on
its current IT system to manage its pharmacy benefit and depend on
locally developed IT solutions to adjudicate nonformulary drug
requests and collect data on outcomes.
Recommendations for Executive Action:
To provide assurance that requests for nonformulary drugs are
adjudicated in a timely fashion, we recommend that the Secretary of
Veterans Affairs take three actions. Specifically, the Secretary
should direct the Under Secretary for Health to establish mechanisms
to ensure that:
* reported nonformulary drug request data are accurate and complete;
* reported nonformulary drug request data are collected at the request-
level and analyzed by VA's PBM, VISNs, and medical centers at this
level; and:
* appeals of denied nonformulary drug requests are tracked.
Additionally, we recommend that the Secretary of Veterans Affairs
direct the Chief Information Officer to clarify plans regarding when
functionality related to the nonformulary drug request process will be
implemented under PRE.
Agency Comments and Our Evaluation:
In commenting on a draft of this report, VA stated that it generally
agreed with our conclusions and concurred with our recommendations.
VA's comments are reprinted in appendix I. Specifically, with regard
to our first recommendation to establish mechanisms to ensure that
requests for nonformulary drugs are adjudicated in a timely fashion,
VA set a target date of October 30, 2010 for developing these
mechanisms and plans to implement them during the first quarter of
fiscal year 2011. With regard to our recommendation to clarify plans
for when functionality related to the nonformulary drug request
process will be implemented under PRE, VA acknowledged the importance
of improving the nonformulary drug request process through PRE, but
stated that addressing patient safety issues in VA's current pharmacy
software takes precedence. VA reported that the department intends to
complete field testing of currently approved PRE increments related to
patient safety by November 1, 2010. VA further stated that it can then
begin an analysis, which could be completed within 90 days, to
determine how improvements to the nonformulary drug request process
will be addressed in future PRE increments. We appreciate VA's focus
on patient safety within PRE, but reiterate the importance of VA
clarifying its plans for the remainder of the project. VA also
provided technical comments, which we incorporated where appropriate.
We are sending copies of this report to the Secretary of Veterans
Affairs and appropriate congressional committees. In addition, the
report is available at no charge on the GAO Web site at [hyperlink,
http://www.gao.gov].
If you or your staffs have questions about this report, please contact
me at (202) 512-7114 or at dickenj@gao.gov. Contact points for our
Office of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff members who made key
contributions to this report are listed in appendix II.
Signed by:
John E. Dicken:
Director, Health Care:
List of Congressional Addressees:
The Honorable Tim Johnson:
Chairman:
The Honorable Kay Bailey Hutchison:
Ranking Member:
Subcommittee on Military Construction, Veterans' Affairs, and Related
Agencies:
Committee on Appropriations:
United States Senate:
The Honorable Chet Edwards:
Chairman:
The Honorable Zach Wamp:
Ranking Member:
Subcommittee on Military Construction, Veterans' Affairs, and Related
Agencies:
Committee on Appropriations:
House of Representatives:
The Honorable Michael H. Michaud:
Chairman:
Subcommittee on Health:
Committee on Veterans' Affairs:
House of Representatives:
[End of section]
Appendix I: Comments from the Department of Veterans Affairs:
Department of Veterans Affairs:
Office of the Secretary:
August 13, 2010:
Mr. John E. Dicken:
Director:
Health Care:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Mr. Dicken:
The Department of Veterans Affairs (VA) has reviewed the Government
Accountability Office's (GAO) draft report, VA DRUG FORMULARY: Drug
Review Process Is Standardized at the National Level, but Actions Are
Needed to Ensure Timely Adjudication of Non-formulary Drug Requests
(GA0-10-776) and generally agrees with GAO's conclusions and concurs
with GAO's recommendations to the Department.
The enclosure specifically addresses GAO's recommendations and
provides technical comments to the draft report. VA appreciates the
opportunity to comment on your draft report.
Sincerely,
John R. Gingrich:
Chief of Staff:
Enclosure:
[End of letter]
Enclosure:
Department of Veterans Affairs (VA) Comments to Government
Accountability Office (GAO) Draft Report:
VA Drug Formulary: Drug Review Process Is Standardized at the National
Level, but Actions Are Needed to Ensure Timely Adjudication of Non-
formulary Drug Requests (GA0-10-776):
GAO Recommendation 1: To provide assurance that requests for
nonformulary drugs are adjudicated in a timely fashion, we recommend
that the Secretary of Veterans Affairs take three actions.
Specifically, the Secretary should direct the Under Secretary for
Health to establish mechanisms that:
* Reported nonformulary drug request data are accurate and complete;
* Reported nonformulary drug request data are collected at the request-
level and analyzed by VA's PBM, VISNs, and medical centers at this
level; and;
* Appeals of denied nonformulary drug requests are tracked.
VA Comment: Concur. The Veterans Health Administration's Pharmacy
Benefits Management Office will develop mechanisms to improve the
collection, reporting and analysis of nonformulary request data and
will assist staff from the Office of the Deputy Under Secretary for
Health for Operations and Management to implement the new mechanisms.
The target completion date to develop the mechanisms is October 30,
2010, with implementation beginning in the first quarter of fiscal
year 2011.
GAO Recommendation 2: We recommend that the Secretary of Veterans
Affairs direct the Chief Information Officer to clarify plans
regarding when functionality related to the nonformulary drug request
process will be implemented under PRE.
VA Comment: Concur. Many of the requirements describing the non-
formulary request process are defined, but spread among the
requirements documents describing the Ordering, Clinical Monitoring,
Reporting and Drug file domains defined under the "original" Pharmacy
Reengineering program. Not all parts of these domains have to be
completed to implement the non-formulary request process, but parts of
each would be required. Significant effort will be required to extract
the requirements specific to these functions from those domains, and
to identify any new ones necessary to implement the non-formulary
request functions separate from the other features included in these
domains.
The PRE team and the Pharmacy Benefits Management resources supporting
Pharmacy reengineering are fully engaged to support the current
approved PRE increments for development under the Project Management
Accountability System (PMAS). These increments provide functionality
to address a number of patient safety issues existing in the legacy
pharmacy applications, and are currently planned to complete field
testing by November 1, 2010. While VA recognizes the importance of
improving the non-formulary request process, current safety related
pharmacy re-engineering projects take precedence, and improvements to
the non-formulary request process will be handled in future PMAS
increments. An analysis to determine the schedule and scope for this
work can begin immediately after completion of field testing of
current increments and could be completed within 90 days of initiation.
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
John E. Dicken, (202) 512-7114 or dickenj@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, Jennifer Grover, Assistant
Director; Mark Bird; Leonard Brown; Martha Kelly; Drew Long; Denise
McCabe; Lisa Motley; Jessica Smith; Rachel Svoboda; Eric Trout; and
Merry Woo made key contributions to this report.
[End of section]
Footnotes:
[1] For purposes of this report, we use "providers" to refer to health
care professionals with prescriptive authority within VA.
[2] Drug classes are groups of drugs similar in chemical structure,
pharmacological effect, or clinical use.
[3] For purposes of this report, we use "medical centers" to refer to
VA medical care facilities that provide drug prescriptions.
[4] VistA, which began operation in 1983 as the Decentralized Hospital
Computer Program, is the primary repository of clinical,
administrative, and infrastructure data in VA. VistA is not
standardized at the national level; rather, each medical center is
responsible for maintaining its own VistA system.
[5] VA established VISNs in 1995 to decentralize general decision-
making and budgetary duties from its headquarters. Each VISN oversees
heath care delivery for the VA medical centers in its designated area.
[6] MAP is comprised of practicing VA physicians and clinicians from
VA's PBM. The VPE Committee is comprised of pharmacists representing
each VISN who generally serve both as the VISN representative on the
VPE Committee and the manager of the VISN-Pharmacy Benefits Management
Office. According to PBM officials, a MAP representative sits on the
VPE Committee and a VPE Committee representative sits on MAP.
Additionally, a clinical representative from the Department of Defense
(DOD) sits on both committees.
[7] H.R. Rep. No. 111-188, at 41 (2009). Although H.R. 3082 did not
become law, the conference report for the Consolidated Appropriations
Act for 2010, which included appropriations for VA, noted that the
language of House Report 111-188 should be complied with unless
specifically addressed to the contrary. See H.R. Conf. Rep. No. 111-
366, at 1334 (2009).
[8] VHA Handbook 1108.08, VHA Formulary Management Process, February
2009.
[9] FDA is the agency within the Department of Health and Human
Services responsible for ensuring the safety and effectiveness of
medical products. Before a drug can be marketed in the United States,
it must be approved by the FDA.
[10] For purposes of this report, a "new drug" is an FDA-approved new
molecular entity, which is a drug that includes an active ingredient
that has not previously been approved for marketing in the United
States in any form.
[11] The Chief Consultant heads VA's PBM and is responsible for
planning and directing a variety of VA pharmacy issues including
formulary management.
[12] To achieve variation in the percentage of nonformulary drug
prescriptions dispensed between 2006 and 2009, we selected medical
centers that (1) consistently prescribed a higher level of
nonformulary drugs compared to the average level, (2) consistently
prescribed a lower level of nonformulary drugs compared to the average
level, and (3) prescribed a higher level of nonformulary drugs in 2006
and a markedly lower level in 2009.
[13] GAO, Veterans Affairs: Health Information System Modernization
Far from Complete; Improved Project Planning and Oversight Needed,
[hyperlink, http://www.gao.gov/products/GAO-08-805] (Washington, D.C.:
June 30, 2008).
[14] We determined that data for the remaining eight VISNs and their
medical centers were not reliable for our purposes, because VPEs for
these VISNs told us that medical centers in their regions may include
data on national formulary drugs in the nonformulary drug request data
that they report to VA's PBM.
[15] The National Defense Authorization Act for Fiscal Year 2000
directed the Secretary of Defense to establish a pharmacy benefits
program. See Pub. L. No. 106-65, § 701, 113 Stat. 512, 677-80 (1999)
(codified as amended at 10 U.S.C. § 1074g). As part of this program,
the law directed the Secretary of Defense to establish the P&T
Committee to develop the uniform formulary, and the Uniform Formulary
Beneficiary Advisory Panel to review and comment on the development of
the uniform formulary. The panel was required to include members that
represent the views and interests of beneficiaries.
[16] Local drug files categorize drugs used within VA by a number of
indicators, including whether a drug is on the national formulary or
whether it is a nonformulary drug. The national drug file provides for
standardization of the local drug files in all VA medical centers.
VISNs 2 and 15 have combined local drug files at the regional level.
[17] A VISN formulary committee is a group within each VISN comprised
of clinical personnel such as physicians and pharmacists.
[18] Although providers must receive authorization to prescribe
nonformulary drugs, veterans pay the same copayment for national
formulary and nonformulary drugs. There is no copayment for veterans
receiving medications for treatment of service-connected conditions,
veterans whose incomes fall below the maximum VA pension, and veterans
who are exempt by other special authority. Other veterans are
generally charged $8 for each 30-day prescription, though certain
eligibility groups are charged $9.
[19] According to VA's formulary management handbook, nonformulary
drug requests are only to be approved when: (1) a documented
contraindication exists to national formulary drug(s); (2) a
documented adverse reaction occurred to national formulary drugs(s);
(3) a documented therapeutic failure to national formulary
alternatives exists; (4) no national formulary alternative exists; (5)
the patient has previously responded to a nonformulary drug and
serious risk is associated with a change to a national formulary drug;
or (6) other circumstances having compelling evidence-based clinical
reasons.
[20] VA's formulary management handbook states that emergency requests
for nonformulary drugs are to be addressed immediately.
[21] VSOs are organizations that represent the interests of veterans.
In addition to VSO representatives, veterans can be invited to attend
VSO meetings.
[22] GAO, VA Health Care: VA's Management of Drugs on Its National
Formulary, [hyperlink, http://www.gao.gov/products/GAO/HEHS-00-34]
(Washington, D.C.: Dec. 14, 1999); and GAO, VA Drug Formulary: Better
Oversight Is Required, but Veterans Are Getting Needed Drugs,
[hyperlink, http://www.gao.gov/products/GAO-01-183] (Washington, D.C.:
Jan. 29, 2001).
[23] VA does not review FDA-approved drugs that are not appropriate
for use in the VA population, such as pediatric drugs.
[24] As previously noted, for purposes of this report, a "new drug" is
an FDA-approved new molecular entity, which is a drug that includes an
active ingredient that has not previously been approved for marketing
in the United States in any form. FDA also approves drugs for other
reasons, such as when a prescription drug changes to over-the-counter
status or a drug is approved for a new indication.
[25] If VA determines that drugs within a class are therapeutically
interchangeable, a decision may be made to have drug companies
competitively bid for a committed-use contract. In these contracts, VA
commits to using a drug throughout its health care system, thereby
assuring the company a high volume of use. In turn, the drug company
is more likely to offer a lower price. These contracts do allow for
use of alternative drugs if it is determined that the committed-use
contract drug is not clinically appropriate for a patient.
[26] Other individuals or groups can submit drug review requests
directly to VA's PBM, including the VHA Chief Medical Consultant, the
VHA Chief Medical Officer, the VPE Committee, and MAP.
[27] VISN formulary committees must submit a standardized drug review
request form. Officials from VA's PBM said that they will deny drug
review requests that are not routed through or reviewed by a VISN
formulary committee, or if the request form is incomplete.
[28] Clinicians from VA's PBM develop safety tables to examine
reported adverse drug events within the patient population. The
efficacy tables compare the effectiveness of the drug with others
already on the national formulary and are based on the results of
clinical trials. VA defines an adverse drug event as an injury
resulting from the use of a drug, including adverse drug reactions and
overdoses.
[29] Officials from VA's PBM said that reviews of drugs for removal
from the national formulary are generally completed in a shorter
timeframe than reviews for drug additions and do not involve a formal
process for soliciting comments from VISN and medical center staff.
Officials said that drug class reviews also go through a process
similar to drug additions, but MAP and the VPE Committee must review
class reviews before they go to VA physicians and providers for
comment. Additionally, PBM requires conflict of interest statements
from staff submitting comments on drug class reviews, while for all
other drug reviews, conflict of interest statements are voluntary.
[30] Officials from VA's PBM told us that MAP and the VPE Committee
hold quarterly in-person meetings, three of which are joint meetings
of both groups. They said that the months when the committees do not
meet in-person, they hold separate monthly teleconferences. In-between
meetings, the committees communicate as needed.
[31] Officials from VA's PBM told us that a representative from VA
also sits on DOD's P&T Committee and votes on uniform formulary
decisions; however, VA does not often collaborate with DOD when
developing drug monographs or other documents related to the drug
review process.
[32] According to the Chief Consultant from VA's PBM, restrictions are
generally used to limit prescribing privileges to specially trained
providers or place a quantity limit on a drug. Criteria for use are
clinical guidance that provide instructions on how to appropriately
use a drug.
[33] If a drug does not have established protocols for "off-label"
use, VA's PBM recommends that providers consult with their P&T
committee to determine appropriate use.
[34] The Chief Consultant from VA's PBM told us that PBM monitors data
transmitted from local drug files to ensure that drugs are
appropriately marked as national formulary or nonformulary. If any are
not appropriately marked, PBM asks medical centers to fix this.
[35] Officials from VA's PBM stated that high priority is given to new
drugs and drugs with emerging safety issues. VA's formulary management
handbook states that the review of new drugs is prioritized based on
their relevance to the veteran population and the availability of
comprehensive, clinically relevant information, and that when these
criteria are met reviews of new drugs ordinarily do not exceed one
year. PBM officials also said that a drug may be given higher priority
if there is an increase in demand, the drug has a potential efficacy
benefit over existing drugs, or if there is a drug shortage for
existing alternatives.
[36] Officials from VA's PBM told us that abbreviated reviews are
shorter than standard reviews and are not sent to VISN and medical
center staff for comment. Abbreviated reviews are generally conducted
for new formulations of existing drugs, drugs for which little
available data exist, or drugs that will have little or no use in the
veteran population. Of the 61 drugs VA considered for inclusion on the
national formulary in 2008 and 2009, 24 of the reviews were
abbreviated.
[37] FDA's Web site lists 49 new drugs as being approved in 2008 and
2009. Officials from VA's PBM told us that VA includes all new
biologics in this category. In 2008 and 2009, some new biologics were
not included on FDA's list, which is why VA's number of new drugs
approved is slightly higher than FDA's number.
[38] At the end of 2009, 95 percent of medical centers reported using
CPRS to electronically process nonformulary drug requests.
[39] According to interviews with VPEs and medical center staff,
nonformulary drug requests are typically adjudicated by medical center
pharmacists. However, one VISN has centralized adjudications of
nonformulary drug requests and VISN-level pharmacists adjudicate most
requests.
[40] The VISN that centralized the appeals process is the same VISN
that centralized adjudications of nonformulary drug requests.
[41] In 2001, VHA undertook an initiative--called HealtheVet--to
standardize its health information technology system and eliminate the
approximately 128 different systems used by VISNs and medical centers.
PRE is one of the HealtheVet components.
[42] Among other things, PRE is expected to include new drug file and
pharmacy data management systems, as well as new functions related to
drug ordering, medication dispensing, and clinical monitoring.
[43] Officials from VA's PBM told us that they are prioritizing PRE
requirements based on patient safety.
[44] According to some VPEs whom we interviewed, not all medical
centers have the onsite IT expertise to customize CPRS to perform
these types of functions.
[45] VA officials told us that while OI&T has developed general
requirements for capabilities related to collecting and reporting
nonformulary drug request data, detailed specifications for these
capabilities have not been clearly defined.
[46] In 2008, we reported that VA had experienced significant delays
and challenges with the development and implementation of HealtheVet,
including PRE, and that VA had extended PRE's implementation date from
2008 into 2011. We recommended that VA take several steps to better
ensure the success of HealtheVet including that it develop a project
management plan and a schedule for performing milestone reviews of
HealtheVet projects.
[hyperlink, http://www.gao.gov/products/GAO-08-805].
[47] In June 2009, VA implemented the Program Management
Accountability System in an effort to increase efficiency and
accountability for IT projects, and allow the department to take
corrective actions sooner.
[48] Enhanced drug order checks are one of the capabilities the first
six PRE increments are intended to support. Of the over 40,000 adverse
drug events reported during fiscal year 2008, VA estimated that 526
events were related to dosage order checks and projected that enhanced
drug order checks could have prevented many of these. As a result, VA
has prioritized their development in PRE to better ensure patient
safety.
[49] OI&T officials told us that a number of factors have delayed
implementation of these increments, but that contracting difficulties
were the primary factor. Officials from VA's PBM noted that the way VA
awards contracts for PRE has caused problems. They explained that
contracts for IT staff are awarded for a specified time period rather
than the completion of a deliverable. For example, contractors have
been changed during the middle of major testing activities and halted
progress. OI&T officials said that new contracting guidance under the
Program Management Accountability System should help address this
issue.
[50] When outliers are present, it can be useful to calculate the
median which is the midpoint of the data that separates the lower half
of the distribution from the upper half.
[51] Medical centers that use CPRS to process nonformulary drug
requests electronically may also use it to process requests for
restricted national formulary drugs; however, not all medical centers
have customized CPRS so that it distinguishes the two types of
requests. As a result, CPRS-generated nonformulary drug request
reports may also include data on requests for restricted formulary
drugs.
[52] VPEs and medical center officials provided examples of why
nonformulary drug request adjudications could exceed 96 hours,
including medical center workload and staffing constraints, complex
patient cases, and the need for information from private providers
outside of VA.
[53] In addition to the 7 VISNs, several other VISNs each had at least
one medical center with a reported nonformulary drug request average
adjudication time over 96 hours in 2009. However, VPEs from these
VISNs told us that requests for restricted national formulary drugs
may be included in reported nonformulary drug request data, and as a
result, we did not include them in our total count.
[54] Overall, quarterly nonformulary drug request average adjudication
times for medical centers across the 13 VISNs ranged from 1 hour to
240 hours.
[55] This VPE was from the one VISN that has centralized adjudications
of nonformulary drug requests and appeals and told us that the VISN
reviews the percentage of appeals upheld and overturned by drug,
adjudicating VISN pharmacist, and medical center provider.
[56] A majority of the VPEs who said they sometimes attend VSO
meetings indicated that they do so to discuss pharmacy-related topics.
[57] Patient advocates are VA employees who are responsible for
receiving and acting on complaints from veterans at medical centers. A
report issued by the Institute of Medicine in 2000 found that national
formulary concerns constituted less than 1 percent of all complaints
reported to patient advocates, see Institute of Medicine, Description
and Analysis of the VA National Formulary (Washington, D.C.: 2000).
[58] Another approach, currently employed by DOD, is to make national
P&T committee meeting minutes available online. DOD's minutes include
a more comprehensive discussion of national formulary decisions than
VA's Ez-Minutes. In addition to listing decisions, DOD's minutes
include the clinical evidence used to make decisions, justification
for recommendations, and a breakdown of voting results. The minutes do
not include proprietary drug cost information.
[59] The Uniform Formulary Beneficiary Advisory Panel reviews and
comments on the recommendations of DOD's P&T Committee in order to
provide a beneficiary perspective on formulary decisions. Final
formulary decisions are based on both the P&T Committee's
recommendations and the Uniform Formulary Beneficiary Advisory Panel's
comments.
[End of section]
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