Previous Chapter: 1 Introduction
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.

2

A History of the Policy Landscape

STRATEGIES IMPLEMENTED TO COMBAT THE OPIOID EPIDEMIC

This chapter provides a comprehensive, though not exhaustive, overview of the changing landscape around clinical guidelines and policies related to opioid prescribing since the mid-1990s. In addition to national efforts, this overview demonstrates early guidelines set forth by the Veterans Health Administration (VHA) in 2003 to support clinical decision making around pain management and opioid treatment. VHA clinical guidelines continued to evolve and were subsequently updated (2010, 2017, 2022) along with the agency-wide Department of Veterans Affairs (VA) Opioid Safety Initiative initiated in 2013, which, among many efforts, increased education and monitoring and promoted safe and effective prescribing. These efforts were complemented by other federal agency and state efforts, such as additional clinical guidelines from the Centers for Disease Control and Prevention (CDC) in 2016 and 2022 and the Department of Health and Human Services (HHS) in 2019. In addition, federal legislation was enacted during this time frame, such as the Veterans Access, Choice, and Accountability Act (2014), the Comprehensive Addiction and Recovery Act (2016), and the VA Mission Act (2018), to help support veterans and/or fight the opioid epidemic. The committee recognizes that understanding the policy landscape and how the implementation of new policies changed practices over time is crucial. This chapter describes the context for what individuals faced seeking relief from pain and support from providers and the health care system. Additional policy details are in Appendix D.

Early Attitudes Toward Prescribing Opioids and Pain Management

Attitudes toward managing pain in the mid-1990s and 2000s helped contribute to increased trends in opioid prescription. In 1995, the American Pain Society coined the phrase “pain as the fifth vital sign” (Campbell, 1995). Furthermore, in 1999, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)1 approved standardized pain assessment and management of all patients, which was required to be incorporated into policies of health care organizations and providers to obtain JCAHO-accreditation (Baker, 2017; Ahmedani et al., 2014).

___________________

1 A U.S, based nonprofit organization that accredits more than 22,000 health care organizations and programs in the country. (https://www.jointcommission.org/).

Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.

These new standards2 went into effect in 2012. In 1999, the VHA followed the American Pain Society recommendations, integrating the Pain as the 5th Vital Sign Initiative into the VHA National Pain Management Strategy, whereby routine screening, a published comprehensive pain assessment and management toolkit, and educational campaigns were launched (VA, 2000, 2018b; Mularski et al., 2006; Cleeland et al., 2003; Kerns et al., 2000). In addition, given efforts to improve pain management in patients and the pharmaceutical industry’s push of the use of opioid pharmacotherapy, several organizations, such as the Federation of State Medical Boards and Drug Enforcement Administration, reduced oversight and scrutiny to encourage providers to prescribe opioids to address the unmet needs of chronic pain patients (Tompkins et al., 2017; Van Zee, 2009).

Relevant Clinical Guidelines, Policies, Legislation

Guidelines, policies, and legislation have affected opioid prescribing practices within the context of changing attitudes toward pain management. To provide context, the committee reviewed several VA policies, VA clinical guidelines, and federal legislation that had an impact on opioid prescribing, including by VHA providers, and support for veterans during the study period (2007–2019). In addition, guidelines from other agencies, such as CDC and HHS, were also reviewed (Dowell et al., 2016, 2022; HHS, 2019). Table 2-1 outlines these efforts and includes a summary of VA clinical practice guidelines (CPGs) (inform clinical decision making within the VHA), VHA directives (outline mandatory department policies), federal legislation, and other relevant guidelines or efforts within the VA or of other agencies. Figure 2-1 depicts a timeline of key policies implemented by the VA, various federal agencies, and the federal government between 2001 and 2024.

This chapter is a brief summary of dynamic changes in the attitudes, policies, and CPGs that occurred during the study period of interest. Appendix D provides further detail of the policies and legislation outlined in Table 2-1 as well as other efforts, such as FDA’s Opioids Analgesic Risk Evaluation and Mitigation Strategies and state Prescription Drug Monitoring Programs. Given the dynamic aspects of opioid and benzodiazepine prescribing during the study period, the committee adjusted for these factors in the analytic models (see chapter 3 for more details, section on Accounting for Secular Trends and Variation by Facility).

___________________

2 In 2009, assessment of pain in all patients, except for those receiving behavioral health care, was eliminated as a standard, given concerns that the standards encouraged opioid use (Baker, 2017).

Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.

TABLE 2-1 Opioid Policy Landscape

Opioid-Related Policy and Programs Year Established Summary Source
Prescription Drug Monitoring Program (PDMP) 1939–1 Controlled substance monitoring database. State
VHA National Pain Management Strategy 1998 Established pain management as a national priority. Aims to provide a systemwide standard of care for preventable pain.

Includes the Pain as the 5th Vital Sign Initiative.
VHA
Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines (CPGs) for the Use of Opioids in the Management of Chronic Pain 2003 VA clinician guidelines for opioid initiation, dose, tapering, and assessment and risk management. VA
Veterans Health Administration (VHA) Directive 2009-053: Pain Management 2009 Outlined essential components of high-quality pain care:
  1. timely and appropriate pain assessment,
  2. development and enactment of a pain treatment plan, and
  3. subsequent reassessment of the effectiveness of the plan.

Led to the VHA’s Stepped Care Model for Pain Management (SCM-PM).

VA
VA/DoD Clinical Practice Guideline-Management of Opioid Therapy for Chronic Pain 2010 Updated VA clinician guidelines for opioid initiation, dose, tapering, and assessment of use and risk management. VA
VA Opioid Safety Initiative (OSI) 2013 VA systemwide initiative (strategies include education, pain management, risk mitigation, addiction treatment) to address the opioid crisis. VA
Veterans Access, Choice, and Accountability Act2 2014 Federal legislation to expand options for veterans to receive care from non-VA providers, also known as the “Veterans Choice Program (VCP).” Legislation
VHA Directive 1005: Informed Consent for Long-Term Opioid Therapy for Pain 2014 VA directive requiring education for patients and informed consent is required for long-term opioid therapy for pain. VA
Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain—United States 2016 CDC clinical guidelines for prescribing opioid pharmacotherapy in primary care patients. Advises against opioid and benzodiazepine co-prescribing. CDC
U.S. Food and Drug Administration (FDA) Box Warning 2016 FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepine; requires its strongest warning. FDA
VHA Directive 1306:
Querying State Prescription Drug Monitoring Programs
2016 VA directive that requires providers to query the PDMP for patients receiving a controlled substance prescription. VA
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Opioid-Related Policy and Programs Year Established Summary Source
Comprehensive Addiction and Recovery Act3 2016 Federal legislation requiring VA to
  • Submit patient data to state PDMPs,
  • Ensure VA prescribers have access to their own state’s PDMP,
  • Expand OSI to non-VA facilities caring for veterans,
  • Address veteran pain management.
Legislation
VA/DoD Clinical Practice Guidelines for the Use of Opioids in the Management of Chronic Pain 2017 Updated VA clinician guidelines for opioid initiation, dose, tapering, and assessment and risk management. Incorporates advice recommending against the co-prescribing of opioids and benzodiazepines. VA
VA/DoD Practice Guideline for the Management of Posttraumatic Stress Disorder (PTSD) 2017 VA clinician guidelines and recommendations for veterans with acute stress reaction/disorder, the assessment and diagnosis of PTSD, and the management of PTSD. Recommends against the routine use of benzodiazepines in veterans with PTSD. VA
VA Mission Act4 2018 Enhanced ability for eligible veterans to access health care from non-VHA providers. Legislation
Substance Use Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act5 2018 In Section 399O(a)(1)(ii)(II(c)), enhances state PDMP by linking to other state providers’ prescribing data, such as VHA facilities. Legislation
U.S. Department of Health and Human Services (HHS) Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics 2019 HHS clinical guidelines in reducing opioid dosage or discontinuing LTOT for chronic pain. HHS
Veterans Community Care Program 2019 Per Mission Act, VA program to further enhance veterans’ access to non-VA health care providers, replacing the VCP. VA
VA/DoD Clinical Practice Guidelines for the Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea (OSA) 2019 Provides a general guide to best practices in the assessment, diagnosis, treatment and management for service members or veterans with chronic insomnia disorder and/or OSA. VA/DoD
VA Consensus Paper: Alternatives to Opioids for Acute Pain Management After Dental Procedures 2021 VA consensus paper that reviews the evidence and recommends non-opioid pain pharmacotherapy to manage pain after dental procedures. Wehler et al., 2021
VA/DoD Clinical Practice Guidelines for the Use of Opioids in the Management of Chronic Pain 2022 Updated VA clinician guidelines for opioid initiation, dose, tapering, and assessment and risk management. VA/DoD
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Opioid-Related Policy and Programs Year Established Summary Source
CDC Guideline for Prescribing Opioids for Chronic Pain—United States 2022 Updated CDC clinical guidelines for prescribing opioid pain medication in primary care patients; incorporates HHS clinical opioid tapering guidelines (2019). CDC

1 California became the first state to implement a PDMP program in 1939.

2 Public Law 113-146, Veterans Access, Choice and Accountability Act of 2014, 113th Congress, August 7, 2014.

3 Public Law 114-198, Comprehensive Addiction and Recovery Act of 2016. 114th Congress, July 22, 2016.

4 Public Law 115-182, VA Mission Act of 2018, 115th Congress, June 6, 2018.

5 Public Law 115-271, Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT), 115th Congress, October 24, 2018.

Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Timeline of relevant federal laws, clinical guidelines, and policies related to opioid prescribing in the United States (2001–2024)
FIGURE 2-1 Timeline of relevant federal laws, clinical guidelines, and policies related to opioid prescribing in the United States (2001–2024).
NOTES: FDA = Food and Drug Administration; HHS = Department of Health and Human Services; NASEM = National Academies of Sciences, Engineering, and Medicine; VA = Department of Veterans Affairs; VHA = Veterans Health Administration.
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.

REFERENCES

Ahmedani, B. K., E. L. Peterson, K. E. Wells, D. E. Lanfear, and L. K. Williams. 2014. Policies and events affecting prescription opioid use for non-cancer pain among an insured patient population. Pain Physician 17(3):205-216.

Baker, D. W. 2017. History of the Joint Commission’s pain standards: Lessons for today’s prescription opioid epidemic. JAMA 317(11):1117-1118.

Campbell, J. 1995. APS1995 Presidential Address. APS News. https://fbaum.unc.edu/teaching/articles/Campbell1996Pain.pdf (accessed May 13, 2024).

Cleeland, C. S., C. C. Reyes-Gibby, M. Schall, K. Nolan, J. Paice, J. M. Rosenberg, J. H. Tollett, and R. D. Kerns. 2003. Rapid improvement in pain management: The Veterans Health Administration and the Institute for Healthcare Improvement collaborative. The Clinical Journal of Pain 19(5).

Dowell, D., T. M. Haegerich, and R. Chou. 2016. CDC guideline for prescribing opioids for chronic pain—United States, 2016. JAMA 315(15):1624-1645.

Dowell, D., K. R. Ragan, C. M. Jones, G. T. Baldwin, and R. Chou. 2022. Prescribing opioids for pain — the new CDC clinical practice guideline. Morbidity and Mortality Weekly Report 71(3):1-95.

FDA (U.S. Food and Drug Administration). 2016. FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-serious-risks-and-death-when-combining-opioid-pain-or (accessed August 5, 2024).

HHS (Department of Health and Human Services). 2019. HHS guide for clinicians on the appropriate dosage reduction or discontinuation of long-term opioid analgesics. https://www.cms.gov/about-cms/story-page/cdcs-tapering-guidance.pdf (accessed August 14, 2024).

Kerns, R. D., E. J. Philip, A. W. Lee, and P. H. Rosenberger. 2011. Implementation of the Veterans Health Administration National Pain Management Strategy. Transl Behav Med 1(4):635-643.

Mularski, R. A., F. White-Chu, D. Overbay, L. Miller, S. M. Asch, and L. Ganzini. 2006. Measuring pain as the 5th vital sign does not improve quality of pain management. Journal of General Internal Medicine 21(6):607-612.

Tompkins, D. A., J. G. Hobelmann, and P. Compton. 2017. Providing chronic pain management in the “fifth vital sign” era: Historical and treatment perspectives on a modern-day medical dilemma. Drug and Alcohol Dependency 173 Suppl 1(Suppl 1):S11-S21.

VA (Department Veterans Affairs). 2000. Pain as the 5th vital sign toolkit, edited by Department of Veterans Affairs. https://www.va.gov/PAINMANAGEMENT/docs/TOOLKIT.pdf (accessed April 25, 2024).

VA. 2009. VHA Directive 2009-053: Pain management. Washington, DC: U.S. Department of Veterans Affairs, Department of Defense.

VA. 2016. Querying state prescription drug monitoring programs (PDMP). https://www.mhanet.com/mhaimages/opioid/toolkit/Appendix_VA_PDMP_Policy_2016.pdf (accessed July 2, 2024).

VA. 2019. VA/DoD clinical practice guideline for the management of chronic insomnia disorder and obstructive sleep apnea. Washington, DC: U.S. Department of Veterans Affairs, Department of Defense.

VA/DoD (Department of Veterans Affairs/Department of Defense). 2003. VA/DoD clinical practice guideline for the management of opioid therapy for chronic pain. Washington, DC: U.S. Department of Veterans Affairs, Department of Defense.

VA/DoD. 2010. VA/DoD clinical practice guideline: Management of opioid therapy for chronic pain. Washington, DC: U.S. Department of Veterans Affairs, Department of Defense.

VA/DoD. 2017. VA/DoD clinical practice guidelines for opioid therapy for chronic pain. Washington, DC: U.S. Department of Veterans Affairs, Department of Defense.

VA/DoD. 2022. VA/DoD clinical practice guideline for the use of opioids in the management of chronic pain. Washington, DC: U.S. Department of Veterans Affairs, Department of Defense.

Van Zee, A. 2009. The promotion and marketing of oxycontin: Commercial triumph, public health tragedy. American Journal of Public Health 99(2):221-227.

VHA (Veterans Health Administration). 2014. VHA Directive 1005: Informed Consent for Long-Term Opioid Therapy for Pain. Washington, DC: Departments of Veterans Affairs, Veterans Health Administration.

Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.

VHA. 2019. VHA Directive 1306(1) Querying State Prescription Drug Monitoring Programs (PDMP). Washington, DC: U.S. Department of Veterans Affairs.

VHA. 2020. VHA Directive 1005: Informed Consent for Long-Term Opioid Therapy for Pain. https://www.ethics.va.gov/docs/policy/VHA_Handbook_1005_Opioid_Therapy_IC.pdf (accessed May 13, 2024).

Wehler, C. J., N. H. Panchal, D. L. Cotchery 3rd, O. A. Farooqi, D. K. Ferguson, D. Foran, O. W. Hakki, R. Silva, G. M. Smith, and G. Gibson. 2021. Alternatives to opioids for acute pain management after dental procedures: A Department of Veterans Affairs consensus paper. Journal of the American Dental Association 152(8):641-652.

Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Page 29
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Page 30
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Page 31
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Page 32
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Page 33
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Page 34
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Page 35
Suggested Citation: "2 A History of the Policy Landscape." National Academies of Sciences, Engineering, and Medicine. 2025. Veterans, Prescription Opioids and Benzodiazepines, and Mortality, 2007–2019: Three Target Trial Emulations. Washington, DC: The National Academies Press. doi: 10.17226/28584.
Page 36
Next Chapter: 3 Setting the Stage
Subscribe to Email from the National Academies
Keep up with all of the activities, publications, and events by subscribing to free updates by email.