Medical Necessity Criteria for Medication Safety: Controlled Substances Utilization Service Program
*This policy is managed through the Pharmacy benefit
One-Provider restriction may be considered medically necessary when there is evidence of excessive use, misuse, non-medical use, or diversion of one or more controlled substances by a member, and when one or more attempts to contact and work with the member to establish a plan for appropriate management of controlled substances via case management, chemical dependency treatment, enrollment in a pain management program, or self-imposed restriction to one prescriber, have failed.
When restricted to one-provider, a single provider will be identified for coverage of prescriptions of all controlled substances for the member. The pharmacy claims system will be locked to prevent coverage of prescriptions of controlled medications unless they are prescribed by that provider.
The existence of any one or more of the following criteria or behaviors may be used to identify individuals who may be engaged in the excessive use, misuse, non-medical use, or diversion of controlled substances:
Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.
Controlled substances are defined and categorized by the Drug Enforcement Administration (DEA) under classification C1 through C5 (or Schedule I to Schedule V). The categorization is based upon a substance’s medical use, potential for abuse, and safety or dependence liability. The medical policy encompasses all controlled substances; given all have potential for abuse; the data and evidence below are mainly focused on narcotics or opioids for the treatment of chronic noncancer pain (CNCP).
There are numerous available treatment modalities for CNCP including pharmacologic and non-pharmacologic interventions. Among these, opioids, known for their strong analgesic properties, have gained popularity over the past two decades. Their use is established in the setting of acute, postoperative pain, cancer pain and pain at the end of life. In contrast, the role of opioids for managing CNCP is controversial, owing to the paucity of high-quality evidence demonstrating effectiveness and safety in this patient population. Existing data are limited by suboptimal study designs characterized by largely observational, non-comparative studies, short-term follow-up and significant withdrawal rates. Two Danish epidemiologic studies showed that in a region where opioids are prescribed liberally for pain, the patients receiving opioid analgesics reported worse pain, higher utilization of healthcare, and lower activity levels compared to matched controls. A population-based cohort study from the same authors showed the odds of recovery from chronic pain were four times higher in patients not using opioids, compared with those using opioids for pain management (23, 27-29). While opioid analgesics are indeed effective in some patients, they may not be suitable for all. Therefore it is to the benefit of patients to constructively address the issue of over-prescribing, over-use, and misuse of opioid medications. Due to the substantial evidence of increasing morbidity and mortality associated with prescription opioid use, this medical policy which will guide appropriate use of controlled substances is necessary.
Opioids produce both analgesia and euphoria. The mood altering action of opioids in addition to the physical dependence and addictive qualities of this class of drugs encourages abuse (nonmedical use). Opioid abuse and misuse occurs for a variety of reasons, including self-medication, use for reward, compulsive use because of addiction, and diversion for profit (27). Individuals with chronic pain and co-occurring substance use disorders and/or mental health disorders, are at higher risk for misuse of prescribed opioids. The increasing use of opioid analgesics for treating chronic noncancer pain, and the introduction of high-dose, extended release oral tablet formulations of opioids with good bioavailability, has increased opportunities for the illicit use of prescription opioids. Such use has become a major societal problem, reaching epidemic proportions; it now exceeds the use of street narcotics in the United States. In April 2011, the White House unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the United States. The plan is a collaborative effort involving various agencies. According to the director of the White House Office of National Drug Control Policy (ONDCP) this plan “provides a national framework for reducing prescription drug abuse and the diversion of prescription drugs for recreational use.” Advocacy for prescribing opioids despite the lack of long-term effectiveness, unproven standards, and guidelines with conflicting recommendations, contributes to the epidemic of opioid abuse. Clinical decisions and practice recommendations must rely to a significant extent on practice experience and consensus rather than research evidence in assessing the treatment of acute and chronic noncancer pain.
Evidence supporting long-term benefit of opioid analgesics for managing CNCP is lacking, owing to the predominantly observational and short-term nature of studies. Furthermore, data comparing various opioids and opioids to other analgesics or to nonpharmacologic modalities are also lacking. The harms from prescription opioids to patients and others are substantial and increasingly recognized. When opioids are used, initial risk assessment, careful dose titration and monitoring including functional outcomes, while educating patients is key. It is also important to recognize patients at highest risk of adverse events – those receiving high opioid doses and from multiple providers.
Various guidelines which have been published all agree that prevention of controlled substance abuse is key. For providers, the ability to identify patients who are most “at-risk” for developing prescription drug abuse prior to initiation of opioids is critical. Screening patients to determine their risk of drug abuse prior to beginning opioid therapy is considered standard of practice (27). Several risk factors have been described and include sociodemographic factors, pain and drug-related factors, genetics and environment, psychosocial and family history, psychopathology, and alcohol and substance use disorders. It is suggested that the risk of prescription drug abuse is greatest when risk factors in 3 categories occur in the same individual. In the absence of psychosocial comorbidities and genetic predisposition, pain patients on stable doses of opioids in a controlled setting are unlikely to abuse opioids or develop addiction. On the other hand, patients with a personal or family history of substance abuse, and psychosocial comorbidity, are at increased risk, especially if treatment with opioids is not carefully structured and monitored (Ballantyne). Patients who are undergoing chronic opioid therapy for pain have been shown to have significantly higher Screener and Opioid Assessment for Patients with Pain (SOAPP), Current Opioid Misuse Measure (COMM), and drug misuse index (DMI) scores (p<0.001), indicating a higher risk for misuse (26). In a population-based observational study, subjects with evidence of doctor-shopping were significantly more likely to have a previous history of overdose, or a history of substance abuse (14). These data suggest that both patients and providers may benefit from other treatment options before beginning opioid therapy for pain such as exercise and cognitive behavioral therapy for chronic management.
Indicators of potential excessive use, misuse, non-medical use, or diversion of controlled substance
When treatment with controlled medications has already been initiated, identification of indicators of potential excessive use, misuse, non-medical use, or diversion becomes critical to preventing or intervening in cases of abuse, addiction, or serious adverse events. Clinical experience and studies have identified a number of factors that indicate potential excessive use, misuse, non-medical use, or diversion. There is no factor that is absolutely indicative of excessive use, misuse, non-medical use; identification of one or more factors requires individual patient evaluation to differentiate between inappropriate use and possible appropriate use given a patient’s unique clinical circumstances (23, 38).
The most common indicators of potential excessive use, misuse, non-medical use, or diversion are doctor shopping, and high or escalating doses of opioids. These two are widely used criterion to identify people who may be engaged in non-medical use of controlled substances.
Cantrell et al. (35) use the following criteria for identification of ‘doctor shopping’: 2 or more prescribers within 30 days, greater than 4 during 1 year, and greater than 5 during 1 year (14, 15, 34). Pradel et al. (19) defined doctor shopping as the amount of drug obtained through doctor shopping compared with the amount intended to be prescribed. The use of “pill mills,” in which a prescriber provides ready access to prescriptions or pills, can also be considered a form of doctor shopping (35).
Doctor shopping is directly associated with the incidence of deaths from opioids. Hall et al. (14), reviewed characteristics of decedents who died of prescription drugs in West Virginia and reported that opioid analgesics accounted for 93% of deaths. The authors determined the prescription history of the drug associated with each fatality. Patients who had received controlled drugs from 5 or more prescribers in the year before death were defined as engaging in “doctor shopping,” whereas those whose death was not associated with a valid prescription were considered to have obtained their drugs through “diversion.” Doctor shopping was associated with 63 (21%) of the fatalities and diversion was associated with 186 (63%) of the fatalities. Of the 295 total decedents, 279 (95%) had at least 1 indicator of substance abuse, and those differed according to whether the drug was obtained through diversion or doctor shopping. A report from the CDC reported a rise in prescription opioid-related deaths of 68% between 1999 and 2004. The CDC also studied prescription drug overdoses and found that 10% of patients seeing multiple doctors and typically involved in drug diversion accounted for 40% of the overdoses (see figure below). This illustrates that patients are more likely to overdose if they are seeing multiple doctors or if they are on a high dose of controlled drug.
High or escalating doses of opioids are also associated with a greater incidence of adverse outcomes, including opioid-related fatal overdoses. In a study (24) of 9,940 adults receiving long-term opioid therapy for chronic noncancer pain, those who received 100mg/day or more of morphine equivalent had an 8.9 fold increase in overdose risk (95% CI 4.0-19.7). Although there is not uniform agreement on what constitutes an excessive dose of opioid, there is a general consensus that doses above 200 mg Morphine Equivalent Dose (MED) total daily dose should be considered to be excessive (27).
In addition to doctor shopping and high or escalating doses, other factors that have been identified as indicators of potential excessive use, misuse, non-medical use, or diversion include multiple prescribers of controlled substances, use of multiple pharmacies to fill controlled substances prescriptions, the number of controlled prescriptions in defined time periods, and overlapping or concomitant controlled substances prescriptions. Manchikanti et al. (24) noted that available national data overwhelmingly suggest that the increased supply of opioids, high medical users, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of fatalities. They observed that on average, patients were exposed to 2 different opioids and had 3 different opioid prescribers. Braker et al. (39) found that a retrospective review of payer opioid prescription data and patient charts from a rural family medicine group identified patients with 3 or more prescriptions (average 8.4; standard deviation = 5.5; range 3-28) from 2 or more providers (average 3.7; SD = 1.8, range 2-10) over a 6-month period. Concurrent use of nonopioid analgesics, escalating opioid dosage, and number of providers were the best predictors for adverse events. Findings form other studies are summarized in the table below.
Parente et al. (2) developed a claims-based method to identify patients who may be misusing controlled substances and prescribers who may be providing pharmacologic management that warrants evaluation. They drew data from health insurance claims and used an 11-member multidisciplinary expert panel to define criteria for identifying controlled substance patterns of utilization requiring evaluation. The goal in defining the criteria was to have this be widely applicable to claims databases to identify possible abuse or diversion of controlled substances by patients or mismanagement by prescribers. The table below outlines the ten patterns that were most positively associated with identification of a misuse case.
Additional factors that have been identified as potential indicators of excessive use, misuse, non-medical use, or diversion include (1) frequent early refill requests; altered or forged prescriptions; multiple reports of misplaced, lost, or stolen medications or prescriptions; insistence on a specific controlled substance; missing medical appointments except when a controlled substance refill is expected or needed; increasing symptoms in spite of being on controlled substances; declining activity or functioning in spite of being on controlled substances; refusal to try other non-controlled pharmacologic and non-pharmacologic treatments; reports of or appearing to be intoxicated, somnolent, sedated, or exhibiting withdrawal symptoms; positive results for controlled medications on drug screening tests when none have been prescribed; absence of positive results for controlled medications on drug screening tests when they are being prescribed; concurrent prescriptions for buprenorphine (Suboxone or Subutex) and an opioid; unwillingness to take medications as prescribed; and unwillingness or failure to engage in evidence-based patient management methods.
Although most published studies focus on steps that providers can take to identify patients who are displaying evidence of possible excessive use, misuse, non-medical use, or diversion, a small but growing literature is establishing evidence of actions that can be taken by health insurance companies and managed care companies. For example, Gonzalez et al (26) studied the impact of a care coordination intervention by a managed care organization after identification of potential opioid misuse. Using their database of prescription claims, the organization identified members who filled controlled opioid medications prescribed by three or more providers and filled at three or more pharmacies in a three-month period. Half of these members were randomized to an intervention arm in which a letter was sent quarterly to the prescriber explaining their patient was receiving multiple opioid prescriptions filled at multiple locations. They were also sent a clinical medication report detailing each opioid prescription that was filled by their patient in the past three months, at which pharmacies, and who the other prescribers were. The prescriber was encouraged to contact the other prescribers listed in an effort to coordinate care. For members in the control group, generic letters were sent to the prescriber discussing the importance of opioid management, but no details or identifying information were given. The members in the intervention group showed a 24% greater reduction in number of prescribers, 16% greater reduction in the number of pharmacies used, and a 15% greater reduction in number of controlled opioid prescriptions compared to the control group. The authors concluded that managed care organizations have the opportunity to identify potential opioid misuse and implement care coordination interventions. Additionally the study revealed patients receiving opioid prescriptions from multiple prescribers and pharmacies during short time intervals is evidence of uncoordinated pain management and suggests misuse of opioid medications. Although dependence or addiction to opioid medications cannot be diagnosed by analysis of prescription claims alone, prescription claims may be used as a tool to guide future prescribing and to pinpoint factors associated with the uncoordinated care of a member.
One Prescriber Restrictions
Limiting the prescription and management of controlled substances to a single prescriber has become standard of care for patients receiving chronic treatment for non-cancer disorders. As noted in the previous section, evidence-based studies have documented a direct relationship between the number of prescribers of opioids for a patient and the severity of adverse effects including opioid-related deaths (24, 39). Conversely, limiting opioid prescription and management to a single prescriber significantly reduces the occurrence of severe adverse effects and fatal outcomes associated with treatment with opioids (40).
Systematic reviews of evidence-based treatment guidelines for pain management demonstrate almost universal agreement that controlled medications should be prescribed and managed by a single prescribing physician, or a single treatment team for patients who are managed by a clinic team (41, 42). When a patient’s health care is being managed by multiple provides, which is common, all providers should agree on a single designated prescriber for controlled pain medications (41).
Systematic reviews of evidence-based treatment guidelines have also established the usefulness of patient-provider agreements, also known as patient contracts, when controlled pain medications are utilized for the management of chronic non-cancer pain (41). Reviews of the specific components of patient-provider agreements have consistently identified the identification and utilization of a single prescriber of controlled medications as a key component of such agreements (23, 41).
A number of prominent provider organizations, concerned about escalating numbers and doses of opioid prescriptions, have taken steps to limit and prevent excessive use, misuse, non-medical use, diversion, and adverse outcomes. Group Health Cooperative in Washington state developed and implemented a comprehensive guideline for chronic opioid therapy for patients with chronic non-cancer pain. Compliance with the guideline is mandatory for all of Group Health’s clinicians. Among the stipulations in the guideline is the requirement that for patients taking opioids for chronic non-cancer pain, each patient’s opioids must be prescribed and managed by a single physician (43, 44).
Government agencies have also become increasingly concerned about escalating use of controlled prescription medications, particularly opioids due to the alarming increase in the number of deaths from accidental overdoses (BMJ). Various state and Federal agencies have devised programs targeting excessive use of opioids, including prescription monitoring programs that allow prescribing clinicians to access databases listing all controlled medications prescribed to patients. The state of Washington has also issued mandatory rules for the management of chronic non-cancer pain. Based on the best available evidence, the rules stipulate, among other provisions, that chronic non-cancer pain patients receive all chronic pain management prescriptions from one physician (45).
This policy is managed through the Pharmacy benefit
New policy added to Prescription Drug section. Policy approved with 90-day provide notification hold. The policy is effective February 11, 2013.
Policy effective date delayed and is now April 1, 2013.
Replace policy. Policy updated within the Policy Guidelines, clarifying criteria added, removed and rearranged; Description section removed; Rationale section significantly updated; references added, removed, renumbered and updated. Policy effective date remains 4/1/13.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).