(June 29, 2017): It has been estimated that from 1999 to 2014, more than 165,000 persons died from an overdose of opioid medications in the United States. Researchers also noted that during this same time period, sales of opioids increased in proportion to the rise in deaths resulting from an opioid-related overdose. In an effort to better protect patients from opioid abuse and the public from illegal opioid diversion, state and federal agencies have ramped up their audit and investigation efforts of physician, nurse practitioner, physician assistant, podiatrist and dentist opioid prescribing practices and are actively referring cases alleging improper opioid practices to State Licensure Boards. The Centers for Disease Control and Prevention (CDC) has taken a central role in establishing recommendations and guidance on the ordering of opioids by qualified prescribers when treating patients who suffer from chronic pain. In March 2016, the CDC published “The CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016.” As the document reflects, the CDC expressly intended for the guidance to:
Help ensure that clinicians and patients consider safer and more effective treatment;
Improve patient outcomes such as reduced pain and improved function, and
Reduce the number of persons who develop opioid use disorder, overdose, or experience other adverse events related to these drugs.
Over the past year, a number of state legislatures and professional licensing boards have followed-up with their own restrictions and / or guidance on the parameters to be observed when writing a prescription for opioids or other controlled substances. This article looks back at the CDC guidelines and examines the primary recommendations made by the agency.
I. Overview of the CDC’s Recommendations When Prescribing Opioids:
Although voluntary, the CDC guidance notes that a qualified health care provider’s decision to prescribe opioids should take a number of factors into account. A summary of the CDC’s recommendations are set out below:
Determining When to Initiate or Continue Opioids for Chronic Pain.
Recommendation #1: Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.
Recommendation #2: Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.
Recommendation #3: Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy. Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation.
Recommendation #4: When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.
Recommendation #5: When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to ?50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ?90 MME/day or carefully justify a decision to titrate dosage to ?90 MME/day.
Recommendation #6: Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.
Recommendation #7: Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.
Assessing Risk and Addressing Harms of Opioid Use.
Recommendation #8: Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (?50 MME/day), or concurrent benzodiazepine use, are present.
Recommendation #9: Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.
Recommendation #10: When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.
Recommendation #11: Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.
Recommendation #12: Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.
II. The CDC Prescribing Guidelines are Intended to Address Improper Opioid Prescribing Practices:
Importantly, the March 2016 guidance issued by the CDC was not intended to serve as a restrictive set of guidelines that would prevent a prescribing physician from exercising his or her independent medical judgement. As the Director for the CDC’s National Center Injury Prevention and Control wrote in response to the concerns of a patient suffering from pain:
“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. It helps physicians assess how to safely maintain or discontinue opioid use in patients who are currently on an opioid treatment plan. Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making. . . .
Furthermore, CDC encourages physicians to continue to use their clinical judgement and base their treatment on what they know about their patients. It is the ultimate goal of the Guidelines to ensure people who need them have access to opioids, while reducing opioid related deaths.” (emphasis added).
III. State Efforts to Address Improper Opioid Abuse and Diversion:
Many state legislatures and / or state licensing boards have taken affirmative steps to incorporate one or more of the CDC’s recommendations into their laws and regulations. For instance, legislation addressing improper opioid practices was signed into law by the Governor of Massachusetts at about the same time that the CDC’s guidance was formally published. On March 14, 2016, Governor Charlie Baker signed “An Act Relative to Substance Use Treatment, Education and Prevention.” A number of additional states (Ohio, Kentucky and Indiana) have also action to better ensure that physicians, nurse practitioners and physician assistants qualified to prescribe opioids do so in a manner that will protect patients from abuse and the public from illegal diversion. Most recently, on May 25, 2017, Maryland Governor Larry Hogan, signed-off on “The Prescriber Limits of 2017.” The legislation was enacted as an emergency measure and was found to be needed for the immediate preservation of the public’s health and safety. While all of these statutes are consistent with the overall purpose and goals of the CDC Mach 2016 guidelines, each of them address prescriber limits on opioids and other controlled substances in a different fashion. Moreover, a number of other states have similar legislation that is still pending. It is therefore essential that you carefully monitor the rules in your state, both at the legislative and at the licensing board level, to ensure that your prescribing practices are consistent with applicable standards of care and stay within the four corners of law.
IV. Medicare and Medicaid Patient Considerations:
It is important to keep in mind that deaths due to prescription opioid overdoses have been disproportionately high in elderly and financially disadvantaged populations. Last June, the Office of Inspector General (OIG), issued its report “High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns.” As the report details, in 2015, 1 in 3 Medicare beneficiaries received a prescription for a commonly abused opioid. Additionally, OIG found that these Medicare beneficiaries received prescriptions for an average of five commonly abused opioids during 2015. Moreover, the Medicare population has one of the highest and fastest growing rates of diagnosed opioid use disorder. One researcher found that more than 6 out of every 1000 Medicare beneficiaries suffer from this condition. Unfortunately, the Medicaid population is even worse, at 8.7 per 1000 beneficiaries. The prevalence of opioid use disorder among Medicaid patients is more than 10 times higher than that of populations covered by private insurance.
V. The Collateral Impact of Opioid Misuse on Medicare and Medicaid Program Integrity Audits:
Over the last year, we have seen a significant increase in the number of Medicare and Medicaid audits of pain management physicians and practices by program integrity contractors working for the Centers for Medicare and Medicaid Services (CMS). On the Medicare side, these audits have been dominated by Zone Program Integrity Contractors (ZPICs) and the National Benefit Integrity Medicare Drug Integrity Contractor (NBI MEDIC) responsible for performing data analyses to identify questionable physician prescribing practices.
On the Medicaid side, these audits have typically been conducted by the Medicaid Integrity Contractor (MIC) handling a particular state. In some jurisdictions, where the contractor consolidation process has progressed, pain management professionals have received audit letter from a Unified Program Integrity Contractor (UPIC). UPICs are intended to replace and consolidate the various Medicare and Medicaid program integrity contractors into a single contracting entity.
CMS is actively utilizing its program integrity contractors to identify opioid prescription practices of physicians, nurse practitioners and physician assistants that appear to be different from those of their peers OR appear to be contrary to the best practices outlined in CDC’s guidance. Please keep in mind – once an audit is initiated, every aspect of the care and treatment provided will be subject to review. Even though a physician’s prescribing habits may have been the impetus for an audit, once medical records are submitted for review, the program integrity contractor will examine multiple aspects of the care in its determination of whether the services at issue were medically necessary and qualify for coverage and payment.
As a final point, it is important to remember pursuant to Chapter 4 of the Medicare Program Integrity Manual, Section 4.18.2, that if a ZPIC or UPIC determines that a Medicare provider engaged in “unethical or improper practices,” it is REQUIRED to also make a referral’s to the provider’s state licensure authority, medical boards and professional societies so that these organizations can review the practices and decide whether disciplinary action is required.
VI. Improper Opioid Prescriber Practices are Leading to Sanctions by State Licensure Boards:
To be clear, the government's interest in opioid and controlled substance prescribing practices isn't new. A cursory look at the list of administrative sanctions taken by almost any state's Medical Board and / or Dental Board will confirm that pain medications have been, and will likely continue to be, a significant problem. Unfortunately, the number of opioid-related complaint referrals has risen over the last six months due to the rise in NBI MEDIC and ZPIC audits of provider care, treatment and prescribing practices. Nevertheless, prescribing practices of Federal and state regulators are carefully monitoring the opioid prescribing practices of qualified physicians, nurse practitioners, physician assistants, podiatrists and dentists in their respective jurisdiction. Despite the fact that the CDC March 2016 guidance is “voluntary,” we recommend that pain management professionals review their prescribing practices and verify whether their particular practices are consistent with the recommendations set out in the CDC’s March 2016 guidance. Additionally, you should ensure that your opioid prescribing practices also comply with any requirements established by your state legislature and any state licensing authorities.
Robert W. Liles is Managing Partner at the health law firm, Liles Parker, PLLC. With offices in Washington, DC, Houston, TX, McAllen, TX and Baton Rouge, LA, our attorneys represent pain management physicians and practices around the country in connection with Medicare / Medicaid audits, Compliance Plan reviews and state peer review actions. Should you have any questions, please call us for a free consultation. Robert can be reached at: 1 (800) 475-1906.