November 6, 2017

Following on the heels of President Trump’s declaration of the opioid epidemic as a national public health emergency, the president’s commission on the opioid crisis last week issued its final report containing more than 50 recommendations for addressing what has been called the most serious drug problem in U.S. history.  The report, the heightened focus on opioid addiction and overdose deaths spurred by the president’s directive, and actions by the Centers for Medicare and Medicaid Services (CMS) and other agencies are likely to impact pain specialists and anesthesia providers in several spheres, including prescribing, treatment, prevention, documentation and compliance, diversion prevention, fraud and abuse detection, and reimbursement.

Among other things, the report recommends that Congress and the Administration:

• Distribute funds in the form of block grants to states for opioid abuse treatment and prevention programs and other opioid-related activities.
• Expand access to opioid addiction treatment services by eliminating the Medicaid Institutions for Mental Diseases (IMD) exclusion, which prohibits the use of Medicaid funds for care in mental health and substance use disorder residential treatment facilities with more than 16 beds.  [On November 1, CMS announced a new policy to allow states to design demonstration projects that boost access to treatment for opioid use disorder and other substance abuse disorders.  The policy gives states more flexibility to create programs that improve access to appropriate treatment.] 
• Improve patient privacy laws under the Health Insurance Portability and Accountability Act (HIPAA) to give providers access to information about a patient’s history of substance abuse disorders through the Overdose Prevention and Patient Safety Act.  [The HHS Office of Civil Rights (OCR) released special guidance for doctors shortly after the President’s announcement in order to clarify misunderstandings about when patient information can and cannot be shared.  For example, doctors are considered in compliance with HIPAA if they inform family, friends and caregivers of a patient’s abuse following an opioid overdose because “the patient poses a serious and imminent threat to his or her health through continued opioid abuse upon discharge.”]
• Amend the Controlled Substances Act to allow the Drug Enforcement Administration (DEA) to require all prescribers to participate in approved continuing medical education on opioid prescribing in order to be relicensed.  According to the Commission, this step would help address the findings that some states have not adopted the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain and that physician awareness of the guideline and safe opioid prescribing practices is lacking.  The report stresses that the Guideline “is intended for primary care clinicians, who are treating patients for chronic pain in outpatient settings, and more latitude in decision making should be given to physicians that have specialized training in pain management” so that patients who truly benefit from opioids in the management of their chronic pain conditions can continue to receive them. 
• Remove policy and reimbursement barriers to treatment for substance abuse disorders, including those that limit access to FDA-approved medication-assisted treatment.
• Increase data sharing among state prescription drug monitoring programs (PDMPs), which have been found to be useful in identifying doctor shopping, overdose prevention and other aspects of opioid misuse.
• Combat illicit fentanyl and other opioids by, among other things, establishing a coordinated federal/DEA effort to prevent and detect the diversion of licit fentanyl and other opioids for illicit use or distribution.
• Enforce the Mental Health Parity and Addiction Equity Act (MHPAEA) with a standardized parity compliance tool to ensure that health plans cannot impose less favorable benefits for mental health and substance use diagnoses versus physical health diagnoses.
• Develop model statutes, policies and regulations to ensure informed consent before receiving an opioid for chronic pain. In a section on origins of the epidemic, the report notes:

Sales of prescription opioids in the U.S. nearly quadrupled from 1999 to 2014, largely paid for by insurance carriers.  It is estimated that one out of five patients with non-cancer pain or pain-related diagnoses are prescribed opioids in office-based settings.  From 2007 to 2012, the rate of opioid prescribing steadily increased amongst specialists more likely to manage acute and chronic pain (pain medicine [49%], surgery [37%], physical medicine/rehabilitation [36%]).  Insurance carriers, including Medicare Part D plans, did not serve as a stop-gap to the huge influx of opioid prescriptions.

• Improve reimbursement by payers, including CMS, for a broader range of pain management and treatment services, including alternatives to opioids, physical therapy, PDMP checking and evidence-based behavioral health treatment.
• Use technology and telemedicine to expand the reach of effective drug abuse treatment programs and strategies to underserved areas, including rural communities that have been particularly hard hit.
• Implement naloxone co-prescribing pilot programs to confirm initial research on its effectiveness in preventing opioid overdoses.  The recommendation includes having the Office of National Drug Control Policy (ONDCP) and HHS distribute a summary of existing research on co-prescribing to stakeholders.

Kudos and Concerns

Not surprisingly, the president’s directive and the commission’s report have received a mixture of praise and disapproval.  Patrice A. Harris, MD, chair of the American Medical Association’s Opioid Task Force, said that while the declaration “will offer needed flexibility and help direct attention to opioid-ravaged communities,” ending the epidemic will require “follow through with resources, evidence-based treatment plans and smart public policies at the national and state levels . . . As it stands, it’s easier for patients to access heroin than to access evidence-based treatment and non-opioid pain care.“  But Dr. Harris praised the Commission’s report as “an excellent roadmap” for increasing access to medication-assisted treatment for patients with opioid disorders and to the full range of multidisciplinary pain treatment options.

Others said the report does not go far enough.  “Patients and families who have lost loved ones to the opioid epidemic need less talk and more action from the federal government,” Senator Richard Blumenthal of Connecticut said.  Though the report includes important measures to curb the crisis, “the glaring absence of any recommendation of robust, new funding is a punch in the gut for the countless individuals and families struggling with opioid addiction,” he stated, adding that a new bill, the Combating the Opioid Epidemic Act, would allocate $45 billion over 10 years to curbing the epidemic.

Some experts are skeptical that attempts to address the opioid crisis can be successful in an Administration that has proposed large budget cuts to the National Institutes of Health and the Centers for Disease Control and Prevention as well as the elimination of the Agency for Healthcare Research and Quality.  Andrew Kolodny, an opioid policy researcher at the Heller School for Social Policy and Management at Brandeis University, said the emergency declaration would do little to stem the crisis “without a substantial commitment of federal money and a clear strategy for overhauling the way the country treats addiction.”  He advocated funding to rapidly expand access to effective treatment, stating that “until those treatments are easier to access than heroin or fentanyl, overdose deaths will remain at record-high levels.”

Similarly, Michael Fiori, MD, director of addictions at the Mount Sinai Health System, said the declaration is a positive step, “but it's critical to actualize it with real money and resources immediately to fund outpatient and rehabilitation services and to educate patients, families, and caregivers about this chronic illness.” 

Tracy Jackson, MD, an anesthesiologist at Vanderbilt University, took issue with President Trump’s assertion that teaching people not to start taking drugs would go a long way toward addressing the problem.  That “just say no” approach reveals a fundamental misunderstanding of the nature and causes of opioid addiction and runs counter to decades of research, she said.  “What we really need to do instead of criminalizing or stigmatizing this is recognize that addiction is a chronic brain disease—and treat it as such.” 

The opioid crisis was a major topic at ANESTHESIOLOGY^® 2017, with discussions of new strategies, techniques and alternatives to help prevent opioid dependence and curb the epidemic a focus of many sessions.  So was the current climate for pain specialists, who often receive blame for the opioid crisis and who are likely to remain an ongoing target of audits by the Office of Inspector General.  (See our September 11, 2017 eAlert and the article by Vicki Myckowiak, Esq., in the fall issue of our quarterly newsletter, Communiqué.)

Unfortunately, a small handful of bad apples threaten to tarnish the image of a specialty whose clinicians overwhelmingly work diligently and honestly to deliver the safest, best care to patients with chronic pain.  On the same day President Trump made his announcement, the Department of Justice’s Opioid Fraud and Abuse Detection Unit, which uses data analytics to identify people who may be involved in illegal opioid distribution, announced its first indictment.  The 14-count indictment accuses a physician with Medical Frontiers, a holistic pain management practice in Gibsonia, Pennsylvania, of prescribing Schedule II narcotics “outside the usual course of professional practice and not for legitimate medical purpose.”  Government investigators are likely to be scrutinizing pain specialists more closely than ever.  We advise you to document your prescribing with extra care and review your prescribing practices to ensure that they are in compliance with current regulatory statutes in the states in which you practice.

More will be known in the coming weeks on actions that will be taken in the wake of the president’s directive.  We will continue to update you as new information becomes available.

With best wishes,

Tony Mira
President and CEO