Course Correction: The Opioid Crisis, Regulatory Efforts, and the Role of PhysiciansBy all accounts, the opioid addiction epidemic is one of the most profound tradgedies and public health challenges of our time. Each day, the news is replete with stories about the the significance and wide-ranging impact of the opioid crisis in the United States. The overwhelming flow of addictive pain medications is a topic at the forefront of our national awareness. This article provides an overview of key statistics that show historical trends culminating in the current crisis, a summary of recent regulatory efforts to deal with the epidemic, and practice points on the central role physicians have to fill in addressing the crisis.
The Bad News: Startling Statistics and Scary Truths
The increase in the prescription of opioids over time is startling. Between 1999 and 2015, the amount of opioids prescribed per person tripled. By 2015, Americans were being prescribed enough opioids for every American to be medicated 24/7 for three weeks. In some states, more prescriptions have been dispensed for opioid pain pills than there are people in the state. The rates of opioid prescribing are important because, not surprisingly, the rates of opioid overdose deaths have been shown to closely track these prescribing rates.
The significance and result of the extensive prescription of opioids cannot be overstated. The current statistics tell a harrowing tale of the tremendous cost of the opioid crisis in the form of economic losses, a corresponding heroin epidemic, and in deaths. First, from a purely financial perspective, it is estimated that in a single year, prescription opioid misuse and overdose cost the United States over $78 billion for substance abuse treatment, criminal justice, productivity losses, and increased health care expenses. Additionally, clinicians and law enforcement recognize that the overuse of opioids has, in turn, contributed to a heroin epidemic. As one physician explained: “up to 80 percent of the heroin users we see started off on prescription opioids.”
Finally, and most tragic of all, are the deaths attributable to this epidemic. Opioid overdoses kill 91 Americans each day, and over 165,000 Americans died from a prescription opioid overdose between 1999 and 2014. In 2015 alone, more than 15,000 people died from overdoses involving prescription opioids.
Physicians have questioned the appropriateness of “pain as the fifth vital sign” and the use of a pain scale due to its subjective nature and some suggest that it has contributed to the opioid epidemic. Commenters have also suggested that pain management questions in patient satisfaction surveys “created pressure on hospital staff to prescribe more opioids in order to achieve higher scores on this dimension.” The intense attention on the crisis has brought the opportunities to address these problems into focus.
The Good News: Wide-Ranging Regulatory Efforts
For a number of years, regulators took little or no action to address the problem of overprescribing of opioid pain medications. Fortunately, now state and federal regulators are focused on the issue and have taken a number of overlapping steps to limit inappropriate prescribing, prosecute “pill mill” practitioners, and expand the capacity of the health care system to screen and treat opioid use disorders. These guidelines and new requirements can be helpful tools for physicians who find themselves on the front lines of the battle against opioid abuse.
In March 2016, the CDC published Guidelines for Prescribing Opioids for Chronic Pain (CDC Guidelines). While the CDC Guidelines have no force of law, the document has been foundational for much of the state and federal legislative activity that has occurred in the past 18 months. The guidelines can also be especially helpful for practicing physicians. Key points from the CDC Guidelines are briefly summarized as follows:
- Indication: Opioids are not first-line or routine therapy for chronic pain.
- Initial Prescription Decision: Before starting opioid therapy, clinicians should establish treatment goals; discuss with patients known risks and realistic benefits of opioid therapy; and clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to safety.
- Prescribe lowest effective dose and no more than needed: When opioids are started, clinicians should prescribe the lowest effective dose. Clinicians should reassess evidence of individual benefits and risks when increasing dosage to > 50 MME/day, and avoid increasing dosage to > 90 MME/day or carefully justify such a decision. When opioids are needed for acute pain, prescribe no more than needed (three days or less is often sufficient, rarely more than seven days will be needed).
- Monitoring and follow-up: Clinicians should evaluate benefits and harms with patients within one to four weeks of starting opioid therapy for chronic pain or dose escalation; clinicians should evaluate benefits and harms with patients every three months or more frequently. If benefits do not outweigh harms, clinicians should taper and discontinue.
- Use available risk mitigation tools: Check Prescription Drug Monitoring Programs (PDMPs) for high doses and prescriptions from other providers.
States have set in motion numerous initiatives intended to roll back the epidemic, focusing on increasing use of PDMPs, aligning prescribing activity and payment for prescriptions with the CDC Guidelines and other best practices, and identifying and disciplining or prosecuting individuals and companies responsible for overprescribing. Currently, all 50 states and the District of Columbia have enacted legislation authorizing PDMPs—electronic databases that track prescribing and dispensing of controlled substances and can serve as essential resources for physicians and their practices. While widespread, PDMPs vary in effectiveness, primarily because their use is not mandatory in every state. States with the most comprehensive mandates require that all prescribers query the PDMP when initially prescribing any opioid or benzodiazepines, and perform subsequent checks of the database at three month intervals if prescribing continues. However, some states require PDMP queries based only on subjective criteria, such as a prescriber’s judgment of possible inappropriate use, and other states only require prescribers to query the PDMP in certain contexts, such as opioid treatment programs, workers’ compensation programs, or pain clinics. Increased utilization of PDMPs is associated with declines in opioid prescribing. PDMPs are an important tool for physicians in evaluating the appropriateness of prescribing opioids for individual patients.
A number of states have worked to align prescribing activity and payment for opioid prescriptions with CDC Guidelines or other best practices. For instance, several states have imposed quantity limits on initial opioid prescriptions for acute pain. These types of laws often exclude initial prescriptions for chronic pain, prescriptions for pain associated with cancer diagnosis or treatment and palliative care, and include exceptions when the prescriber determines that the patient’s condition requires a greater dose than that permitted by law. Other states have adopted quasi-regulatory or advisory treatment guidelines.
Some states have taken steps to modify the formulary policies and drug plan management for formularies subject to state control, such as Medicaid or workers’ compensation formularies, to reinforce prescribing guidelines and to minimize use of opioids. For instance, the Texas Department of Insurance created a closed formulary beginning in September 2011, and saw an 81% reduction in prescription for opioids on the “not-recommended” drug list; use of other opioids fell by 8%. The Centers for Medicare and Medicaid Services (CMS) has also urged state Medicaid agencies to require step therapy or prior authorization to limit access to particular opioids.
With respect to enforcement, state medical boards have stepped up disciplinary activity. While traditionally state professional boards have only taken action in response to complaints received, recently some states have granted medical boards access to the state PDMP for the purpose of monitoring prescribing patterns. State attorneys general have also formed partnerships with other state and federal agencies to leverage investigatory resources and enforcement efforts against prescribers as well as against opioid manufacturers and distributors. Forty-one attorneys general are now participants in a national investigation of the companies responsible for manufacturing and distributing the majority of the nation’s opioids, recently serving Civil Investigative Demands and information demand letters as part of their coordinated effort.
Finally, many state medical, nursing, and pharmacy boards have expanded access to professional continuing education on safe prescribing practices, increasingly imposing mandatory requirements. The increased availability of education on this subject is designed to inform physicians about the challenges with opioids and how to address abuse.
The federal government has also unleashed its financial, regulatory, and prosecutorial resources to fight the opioid epidemic.
CMS published an Opioid Misuse Strategy, which identified four priority areas of focus in CMS’ efforts to combat opioid misuse and promote treatment and recovery supports: (1) implement more effective person-centered and population-based strategies to reduce the risk of opioid use disorders, overdoses, inappropriate prescribing, and drug diversion; (2) expand naloxone use, distribution, and access, when clinically appropriate; (3) expand screening, diagnosis, and treatment of opioid use disorders with an emphasis on increasing access to medication-assisted treatment; and (4) increase the use of evidence-based practices for acute and chronic pain management.
The United States Drug Enforcement Administration (DEA) has taken administrative and criminal action against all participants in the distribution chain of controlled substances, including prescribers, pharmacies, distributors, and manufacturers. DEA is charged with enforcing the Controlled Substances Act (CSA), 21 U.S.C. 801 and accompanying regulations, which prohibit practitioners from dispensing controlled substances except “for a legitimate medical purpose” and “in the usual course of professional practice.” Practitioners who fail to comply with the CSA and accompanying regulations are subject to administrative action, including revocation of their DEA registration, and can be criminally prosecuted if they knowingly or intentionally prescribe not for a legitimate medical purpose or outside the usual course of professional practice. DEA, which also regulates manufacturers of controlled substances, has additionally proposed cutting the amount of controlled substances to be manufactured in 2018 by 20% compared to 2017.
The United States Department of Justice (DOJ) has vigorously prosecuted opioid overprescribers under the CSA, as well as under federal fraud and abuse statutes. On July 13, 2017, Attorney General Sessions and former Department of Health and Human Services (HHS) Secretary Tom Price announced the largest ever health care fraud enforcement action, which included 120 defendants charged for their roles in prescribing and distributing opioids. The focus of the enforcement was on billing for medically unnecessary drugs. Attorney General Sessions also announced a pilot Opioid Fraud and Abuse Unit, composed of 12 prosecutors designated to focus on investigating and prosecuting individuals contributing to the opioid epidemic in 12 federal districts in Florida, Michigan, Alabama, Tennessee, Kentucky, Maryland, Pennsylvania, Nevada, Ohio, California, North Carolina, and West Virginia.
Also this summer, the HHS Office of Inspector General (OIG) released a Data Brief, Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing, which identified about 400 prescribers with questionable opioid prescribing patterns. OIG identified the prescribers by (1) identifying beneficiaries receiving extreme amounts of opioids (> 240 mg daily MED for 12 months, (2) identifying beneficiaries who appear to be doctor shopping, and (3) identifying the prescribers who ordered opioids for the highest numbers of beneficiaries at serious risk. The Data Brief observes that nurse practitioners and physician assistants make up about one third of the prescribers with questionable prescribing patterns for beneficiaries at serious risk. The Data Brief demonstrates that the government has access to fairly sophisticated data mining tools that enable it to identify outlier prescribers, at least with respect to federal health care beneficiaries, and suggests that outlier prescribers are likely targets for enforcement.
Finally, CMS has worked to align Medicare plans, including Part D, with the CDC Guidelines.
Private Sector Activity
Even the private sector appears to be joining efforts to limit access to prescription opioid medications. On September 21, 2017, CVS announced that beginning in February 2018, it would limit opioid prescriptions to seven days or less for certain patients with acute pain who hadn’t previously taken an opioid prescription. It will also limit patients with chronic pain to a maximum daily dose of 90 morphine milligram equivalents, or MMEs. It remains to be seen whether other national pharmacy chains will follow suit.
The Role Of Physicians
Physicians’ role of helping and protecting their patients is at the heart of the practice of medicine. Focused rules and guidelines from many sources are aligning to provide support to physicians as they work to prevent opioid misuse and to detect and address opioid abuse in their patients. Physicians should get educated on the issues. Continuing education on these issues has become more available and, in some states, even mandatory.
- Physicians should be alert and attentive to the changing standard of care, complying with legal limits on opioid prescriptions which are newly enacted in many states.
- Physicians and their practices can look to the CDC Guidelines which, while voluntary, help direct parameters for initial prescriptions, dosages, and monitoring. These can serve as the basis for the implementation of internal policies relating to opioids.
- Available PDMPs should be used to their fullest extent. Although these are not mandatory in every state, they are an important tool to inform medical judgment and help identify patients with opioid problems, including those who may be doctor-shopping.
- Physicians can use legal limits on prescriptions, payment limits from private and government payers, and dosage limits imposed by pharmacies like CVS as additional support to bolster their limitation on opioid prescriptions for patients.
 Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. Prescription Opioid Overdose Data, citing Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement Administration; 1999 and QuintilesIMS Transactional Data Warehouse; 2015. Available at https://www.cdc.gov/ vitalsigns/opioids/infographic.html (last visited Oct. 12, 2017).
 The Healthcare Fraud Prevention Partnership Whitepaper. Healthcare Payer Strategies to Reduce the Harms of Opioids, p. 10 (Jan. 2017). Available at https:// downloads.cms.gov/files/hfpp/hfpp-opioid-white-paper.pdf (last visited Oct. 12, 2017).
 Id. at p. 9
 John W. Mitchell, Opioids: Addressing the Epidemic. Healthcare Journal of Baton Rouge (July/August 2017) at p. 33. (Quoting Stephen Mette, MD, Chief Medical Officer at the University of Arkansas for Medical Sciences).
 Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Division of unintentional Injury Prevention. Prescription Opioid Overdose Data. Available at https://www.cdc.gov/drugoverdose/data/ overdose.html (last visited Oct. 12, 2017).
 The Healthcare Fraud Prevention Partnership Whitepaper, supra note 3 at p. 10.
 Supra, note 6.
 In 1996, the American Pain Society introduced “pain as the 5th vital sign.” See National Pharmaceutical Counsel Whitepaper on Assessment of Pain. Available at http://americanpainsociety.org/uploads/education/section_2.pdf (last visited Oct. 12, 2017).
 See Practical Pointers for Hospitals Handling the Opioid Crisis. American Health Lawyers Association. Webinar (Sept. 9, 2007). See also John W. Mitchell, Opioids: Addressing the Epidemic. Healthcare Journal of Baton Rouge (July/August 2017) at p. 33. (Quoting Beau Clark, MD, East Baton Rouge Parish Coroner and emergency room physician).
 Quality Data Reporting Requirements for Specific Providers and Suppliers, CMS Final Rule, 82 Fed. Reg. 38322, 38329 (Aug. 14, 2017).
 See Centers for Disease Control, CDC Guidelines for Prescribing Opioids for Chronic Pain – United States, 2016 (March 18, 2016), https://www.cdc.gov/ mmwr/volumes/65/rr/rr6501e1.htm.
 See PDMP Prescriber Use Mandates: Characteristics, Current Status, and Outcomes in Selected States, Prescription Drug Monitoring Program Center of Excellence at Brandeis (May 2016), http://www.pdmpassist.org/pdf/COE_ documents/Add_to_TTAC/COE%20briefing%20on%20mandates%203rd%20 revision.pdf.
 The Federation of State Medical Boards (FSMB) has published a Model Policy, Guidelines for the Chronic Use of Opioid Analgesics, Treatment Guidelines, which may be incorporated by state legislatures or state medical boards as criteria for use in evaluating a clinician’s management of a patient with pain. See Federation of State Medical Boards, Guidelines for the Chronic Use of Opioid Analgesics (Apr. 2017), https://www.fsmb.org/Media/Default/PDF/Advocacy/Opioid%20 Guidelines%20As%20Adopted%20April%202017_FINAL.pdf. The Guidelines expressly state that the focus is to promote safe and evidence-based prescribing of opioids without creating any specific standard of care.
 See, e.g. Conn. Gen. Stat. 20-14o(b) (7 day limit for initial prescriptions for outpatient use); 32 MRSA 2210(1)(D) (7 day limit for treatment for acute pain); Mass Gen. Laws Ch. 94C Sec. 19D (7 day supply for initial opioid prescriptions in outpatient setting); N.J. Stat. 24:21-15.2 (5 day limit on initial prescriptions for acute pain); 35 PS. 873.3(a) (7 day limit for opioid prescriptions in ED or urgent care center).
 See, e.g., Medical Board of California, Guidelines for Prescribing Controlled Substances for Pain (Nov. 2014), http://www.mbc.ca.gov/licensees/prescribing/ pain_guidelines.pdf; Pennsylvania Department of Health, Pennsylvania Guidelines on the Use of Opioids to Treat Chronic Non-Cancer Pain; Pennsylvania Emergency Department Pain Treatment Guidelines, Pennsylvania Guidelines on the Use of Opioids in Dental Practice, http://www.health.pa.gov/My%20Health/ Diseases%20and%20Conditions/M-P/opioids/Pages/Prescribing-Guidelines. aspx#.WcUhcVtSyUk (last visited Sept. 22, 2017).
 See Texas Department of Insurance, Texas Reduces Costs, Opioid Use With Closed Formulary (Aug. 16, 2016), https://www.tdi.texas.gov/news/2016/ dwc08162016.html.
 U.S. Department of Health and Human Services, CMCS Informational Bulletin, Best Practices for Addressing Prescription Opioid Overdoses, Misuse, and Addiction (Jan. 28, 2016), https://www.medicaid.gov/federal-policy-guidance/ downloads/CIB-02-02-16.pdf.
 See North Carolina Medical Society, Medical Board Launches New Program to Monitor Opioid Prescribing (Apr. 20, 2016), http://www.ncmedsoc.org/medical-board-launches-new-program-to-monitor-opioid-prescribing/.
 See generally, National Association of Attorneys General, Attorney General Programs and Initiatives Listed by State, http://www.naag.org/publications/ papers-briefs-and-other-research/nagtri-prescription-opioid-projects/prescription-opioid-education-toolkit-for-consumer-education/attorney-general-program-and-initiatives-listed-by-state.php.
 41 States to Investigate Pharmaceutical Companies Over Opioids, NPR (Sept. 19, 2017), http://www.npr.org/sections/thetwo-way/2017/09/19/552135830/41- states-to-investigate-pharmaceutical-companies-over-opioids.
 CMS, Opioid Misuse Strategy (Jan. 5, 2017), https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse- Strategy-2016.pdf.
 See, e.g., Examining the Growing Problems of Prescription Drug and Heroin Abuse: Hearing Before the Subcomm. On Oversight and Investigations of the H. Comm. On Energy and Commerce, 113th Cong. (Apr. 29, 2014) (statement of Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, DEA). DEA was criticized recently by Mr. Rannazzisi, now former Deputy Assistant Administrator, for not being aggressive enough and for being derailed by pressure from Congress and the drug industry in enforcing drug control laws. See 60 Minutes: The Whistleblower (CBS television broadcast Oct. 15, 2017), available at https://www.cbsnews.com/news/ex-dea-agent-opioid-crisis-fueled-by-drug-industry-and-congress/; see also Scott Higham and Lenny Bernstein, The Drug Industry’s Triumph over the DEA, The Wall Street Journal (Oct. 15, 2017).
 The Controlled Substances Act makes it unlawful for any person, except as authorized by the statute and regulations, to “knowingly or intentionally . . . distribute or dispense, or possess with intent to . . . distribute or dispense a controlled substance.” 21 U.S.C. 841(a)(1). A practitioner who is licensed to administer and/or dispense such drugs under applicable state law and is registered with the DEA is exempt from this broad prohibition. 21 U.S.C. 353(B), 802(21), 829(b). However, a practitioner may only prescribe and/or dispense a controlled substance “for a legitimate medical purpose’ and “in the usual course of professional practice.” 21 C.F.R. 1306.04(a).
 See, e.g. United States v. Moore, 423 U.S. 122, 134 (1975); United States v. Hurwitz, 459 F.3d 463 (4th Cir. 2006);
 See Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018, 82 Fed. Reg. 36830-34.
 United States Department of Justice, Press Release, National Health Care Fraud Takedown Results in Charges Against Over 412 Individuals Responsible for $1.3 Billion in Fraud Losses (July 13, 2017), https://www.justice.gov/opa/pr/national-health-care-fraud-takedown-results-charges-against-over-412-individuals-responsible.
 United States Department of Justice Press Release, Attorney General Sessions Announces Opioid Fraud and Abuse Detection Unit (Aug. 2, 2017), https://www. justice.gov/opa/pr/attorney-general-sessions-announces-opioid-fraud-and-abuse-detection-unit.
 HHS OIG, Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing, https://oig.hhs.gov/oei/reports/oei-02-17-00250.pdf (last visited Sept. 27, 2017).
 CMS, Press Release, CMS finalizes 2018 payment and policy updates for Medicare Health and Drug Plans, and releases a Request for Information (Apr. 3, 2017), https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-04-03.html.
 CVS Health Moves to Limit Access to Opioid Painkillers, The Wall Street Journal (Sept. 21, 2017).