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.
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).
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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/).
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).
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).
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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).
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:
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 |
| Opioid-Related Policy and Programs | Year Established | Summary | Source |
|---|---|---|---|
| Comprehensive Addiction and Recovery Act3 | 2016 |
Federal legislation requiring VA to
|
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 |
| 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.
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.
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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).
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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.
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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.
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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.
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.