Corporate Medical Policy

Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: opioid_testing_in_pain_management_and_substance_abuse 01/01/2019 N/A 01/01/2020 01/01/2019 Policy Effective April 1, 2019 Description of Procedure or Service Definition of Pain Pain is defined by International Association of the Study of Pain (IASP) (Merskey, 2011) as an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. If pain persists for longer time than three months, pain is assumed to be chronic. Treatment options for pain management include opioid and non-opioid medications that could be measured in body fluids of patients. Laboratory drug testing is usually used for compliance monitoring and pharmacotherapy optimization in non-cancer pain patients with other clinical tools by prescribing physicians. Methodology/Lab The testing performed could be qualitative, semi-quantitative or quantitative. The most common technology used for drug testing is liquid or gas chromatography with or without mass spectrometry and immunoassays. In drug testing, terms such as definitive or presumptive are often used with quantitative or qualitative assays. Presumptive drug testing usually refers to drug testing that may be qualitative, semi-quantitative, or quantitative. Presumptive drug testing is used to identify use or non-use of a drug or a drug class, but this type of testing can t distinguish between structural isomers and therefore drug test result is presumptive. Definitive drug testing usually refers to a more definitive methodology such as mass spectrometry or chromatography because these methods are capable to identify use or non-use of a specific drug and/or its associated metabolites. Definitive drug testing can be either quantitative or qualitative (Jannetto & Langman, 2018). Medications used: Medications for acute pain: common non-narcotic analgesics Aspirin, Acetaminophen, Non-Steroidal Anti-Inflammatory Agents (NSAIDs) narcotic analgesics opioid and COX inhibitor combinations Medications for chronic pain: Antidepressants Anticonvulsants Neuroleptics Antispasmodics and muscle relaxants Chronic opioid medication NOTE: This policy does not address the use of drug testing in the following circumstances: Page 1 of 10

Policy A. State, Federally regulated and legally mandated drug testing (i.e., court-ordered drug screening, forensic examinations). B. Non-forensic testing for commercial driver s licensing or any other job related testing (i.e., as a prerequisite for employment or as a means for continuation of employment). C. As a component of routine physical/medical examination. D. As a component of care rendered in an urgent/emergency situation. E. As a routine component of a behavioral health assessment. ***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician. BCBSNC will provide coverage for opioid testing in pain management and substance abuse when it is determined to be medically necessary because the medical criteria and guidelines shown below are met. Benefits Application This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy. When Opioid Testing in Pain Management and Substance Abuse is covered 1. Presumptive drug screening (Qualitative, semi-quantitative or quantitative) IS CONSIDERED MEDICALLY NECESSARY when ANY of the following criteria are met: a. To assess a patient under treatment for pain or substance abuse or dependence when clinical evaluation of the patient (history/signs/symptoms) suggests the use of nonprescribed medications or illegal substances. b. In pregnant individuals at high-risk for substance abuse in whom suspicion of drug use exists as a result of the answers to substance abuse screening questions or indicated by information from the PDMP, as documented in the medical record. c. In newborns when there is a history of maternal substance abuse or agitated/altered mental status in the mother d. In candidates for organ transplant who have a history of substance abuse, to demonstrate abstinence prior to transplant 2. The random urine presumptive drug testing for management and compliance monitoring of a member under treatment for substance abuse or dependence IS CONSIDERED MEDICALLY NECESSARY at the following frequency after baseline at initial evaluation and must be documented in the patient s medical record: a. For patients with 0 to 90 consecutive days of abstinence, qualitative drug testing at a frequency of 1 to 2 per week is considered medically necessary b. For patients with > 90 consecutive days of abstinence, qualitative drug testing at a frequency of 1 to 3 in one month is considered medically necessary. 3. Presumptive urine drug testing in patients on opioid pain medication IS CONSIDERED MEDICALLY NECESSARY in chronic non-cancer pain patients when ANY of the following criteria are met: a. Prior to initiating chronic opioid pain therapy in chronic non-cancer pain, to determine if the patient has been exposed to controlled substances or potentially confounding illicit drugs. b. To verify a patient s compliance with treatment or identify undisclosed drug abuse as part of routine monitoring for individuals who are receiving treatment for non-cancer chronic pain with prescription opioid pain medication. The random testing interval and Page 2 of 10

drugs selected for testing should be based on the individual s history, condition and treatment, as documented in the medical record. Monitoring of low risk (as defined by a risk assessment tool) individuals on chronic opioid therapy, up to one (1) time per year after initiation of therapy. Monitoring of moderate risk (as defined by a risk assessment tool) individuals on chronic opioid therapy, up to two (2) times per year after initiation of therapy. Monitoring of high risk (as defined by a risk assessment tool) individuals on chronic opioid therapy, up to four (4) times per year after initiation of therapy. For individuals with aberrant behavior (lost prescriptions, multiple requests for early refills, and opioids from multiple providers, unauthorized dose escalation, apparent intoxication, etc.) testing at the time of visit is considered medically necessary. 4. Testing of cancer patients on opioid pain medication IS CONSIDERED MEDICALLY NECESSARY. 5. Drug Testing in patients with substance abuse disorder IS CONSIDERED MEDICALLY NECESSARY. 6. Confirmatory/definitive qualitative or quantitative drug testing IS CONSIDERED MEDICALLY NECESSARY when laboratory-based definitive drug testing is specifically requested, and the rationale documented by the patient s treating physician and ANY of the following conditions is met: a. The result of the presumptive drug screen is different than that suggested by the patient s medical history, clinical presentation or patient s own statement. For example: i. The test was negative for prescribed medications, ii. Positive for a prescription drug with abuse potential which was not prescribed, or iii. Positive for an illegal drug b. For diagnosing and monitoring individuals with substance use disorder or dependence, when accurate and reliable results are necessary for treatment decisions. i. For patients with 0 to 30 consecutive days of abstinence, random definitive drug testing at a frequency of not to exceed 1 per week is considered medically necessary. ii. For patients with 31 to 90 consecutive days of abstinence, random definitive drug testing at a frequency of 1 to 3 per month is considered medically necessary. More iii. than 3 definitive drug tests in one month does not meet coverage criteria. For patients with > 90 consecutive days of abstinence, definitive drug testing at a frequency of 1 to 3 every three months is considered medically necessary. More than 3 definitive drug tests in a 3 month period does not meet coverage criteria. c. For monitoring of individuals on opioid therapy, to ensure adherence to the therapeutic plan, for treatment planning, and for detection of other, non-prescribed opioids. d. A presumptive test does not exist or does not adequately detect the specific drug or metabolite to be tested (for example, specific drugs within the amphetamine, barbiturate, benzodiazepine, tricyclic antidepressants, and opiate/opioid drug classes as well as synthetic/analog or designer drugs) e. Definitively identify specific drugs in a large family of drugs f. To identify drugs when a definitive concentration of a drug is needed to guide management g. In newborns when there is a history of maternal substance abuse or agitated/altered mental status in the mother h. In candidates for organ transplant who have a history of substance abuse, to demonstrate abstinence prior to transplant When Opioid Testing in Pain Management and Substance Abuse is not covered Testing that is considered not medically necessary includes but is not limited to: Any panel coding other than G0480 (1-7 drug classes) Page 3 of 10

Same-day testing of the same drug or metabolites from two different samples (e.g. both a blood and a urine specimen) by either qualitative or definitive analyses. Blanket orders or routine standing orders for all patients in the physician s practice Reimbursement Limitations 1. Only Urine specimen will be covered. Blood specimen will be covered for patients with Chronic Renal Failure. 2. Confirmatory/definitive testing should be supported by documentation of rationale in the patient s medical record. 3. Confirmatory/definitive drug testing is allowed as meeting coverage criteria based on patient specific indications, including stage of screening, treatment, or recovery, medication response, and clinical assessment, and when accurate results are necessary to make clinical decisions. 4. It is not reasonable and necessary for a physician to perform qualitative point-of-care testing and order presumptive testing from a reference laboratory. In other words, more than one presumptive test result per patient per date of service regardless of the number of billing providers does not meet coverage criteria. 5. It is not reasonable and necessary for a physician to perform presumptive immunoassay testing and order presumptive immunoassay testing from a reference laboratory with or without reflex testing. More than one presumptive test result per patient per date of service regardless of the number of billing providers does not meet coverage criteria. Policy Guidelines According to the National Institute on Drug Abuse (2015), illicit drug use continues to rise within the United States. In 2013, an estimated 24.6 million Americans aged 12 or older 9.4 percent of the population had used an illicit drug in the past month. This number is up from 8.3 percent in 2002. The increase mostly reflects a recent rise in use of marijuana, the most commonly used illicit drug (National Institute on Drug Abuse, 2015). Methamphetamine use has increased as well. The National Survey on Drug Use and Health (2013) presented this summary on national findings: In 2013, the rate of current illicit drug use among adults aged 26 or older was 7.3 percent, including rates of 5.6 percent for current use of marijuana and 2.1 percent for current nonmedical use of psychotherapeutic drugs. Less than 1 percent of adults in this age group were current users of cocaine (0.5 percent), hallucinogens (0.3 percent), heroin (0.1 percent), and inhalants (0.1 percent). The rate of current illicit drug use in 2013 was similar to the rate in 2012 (7.0 percent), but it was higher than the rates in 2002 to 2011 (ranging from 5.5 to 6.6 percent). Also, the rate of current marijuana use in 2013 (5.6 percent) was similar to the rate in 2012 (5.3 percent), but it was higher than the rates in 2002 to 2011 (ranging from 3.9 to 4.8 percent). Among adults aged 50 to 64, the rate of current illicit drug use increased from 2.7 percent in 2002 to 6.0 percent in 2013. For adults aged 50 to 54, the rate increased from 3.4 percent in 2002 to 7.9 percent in 2013. Among those aged 55 to 59, the rate of current illicit drug use increased from 1.9 percent in 2002 to 5.7 percent in 2013. Among those aged 60 to 64, the rate of current illicit drug use increased from 1.1 percent in 2003 and 2004 to 3.9 percent in 2013. State and Federal Regulations, as applicable There are 383 results in FDA 510 (k) Premarket Notification list as of 04/16/2018. A multitude of urine drug tests are available. Guidelines and Recommendations Several organizations recognize the benefit of drug screening/testing for the identification and management of drug misuse and abuse, standard guidelines for who should be tested, what test should be used, and how frequently testing should occur, are lacking. Page 4 of 10

The Centers for Disease Control and Prevention (CDC) and the American College of Obstetricians and Gynecologists (ACOG) recommend that providers discuss drug use with all women and utilize appropriate screening tools for identification of those women who have a drug problem. Also, care should be taken when prescribing pain medications to a pregnant woman, to ensure that only the amount of drug needed to address the current pain is prescribed, and that the medication will not adversely interact with other medications she is taking. Use of PDMPs are also encouraged. ACOG does not recommend universal drug testing for all pregnant women. Rather, they support targeted testing for those individuals with a positive verbal interview screen, noting that urine drug screening is an adjunct to detect or confirm substance abuse, but should be performed only with the patient s consent and in compliance with state laws. In 2016, the Centers for Disease Control and Prevention (CDC) published guidelines for prescribing opioids for chronic pain (Dowell et al, 2016). The CDC recommended that 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 category: B, evidence type: 4). The CDC stated that urine drug tests can provide information about drug use that is not reported by the patient. In addition, urine drug tests can assist clinicians in identifying when patients are not taking opioids prescribed for them, which might in some cases indicate diversion or other clinically important issues such as difficulties with adverse effects The Federation of State Medical Boards (FSMB) indicates in their Guidelines for Chronic Use of Opioid Analgesics policy that for patients being prescribed opioids for chronic pain management that the initial work-up should include a system review and relevant physical examination, as well as laboratory investigations as indicated (FSMB, 2017). They also note the utility of periodic testing for monitoring adherence to the patient s treatment plan and to detect non-prescribed drugs. Regarding frequency of testing, Patients being treated for addiction should be tested as frequently as necessary to ensure therapeutic adherence, but for patients being treated for pain, clinical judgment trumps recommendations for frequency of testing. Additionally, relative to how testing should be performed, the Federation of State Medical Boards notes that POC tests have significant limitations in both sensitivity and specificity, and therefore the use of point of care testing for the making of more long term and permanent changes in management of people with the disease of addiction and other clinical situations may not be justified until the results of confirmatory testing with more accurate methods are obtained. They also note that initial testing could be done using immunoassays and followed up by a more specific technique such as GC/MS or other chromatography-based technique. They highlight the importance of knowing specific drug and metabolites, not just the class of drug for the pain management. The American Academy of Pain Medicine (AAPM) noted that urine and/or blood drug screening may be helpful in ruling out the issue of diversion, along with other non-testing actions (AAPM, 2013). They also noted that when appropriate, the patient should undergo a baseline drug screening exam. They highlighted the importance of random urine drug screening for the ongoing monitoring of patient compliance to the treatment plan. The American Pain Society and American Academy of Pain Medicine joint guidelines panel released their opioid treatment guidelines titled Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Non-cancer Pain in 2009 (Chou et al, 2009). In this document they addressed the monitoring of controlled substances use via UDT as part of a chronic opioid treatment (COT) program. Authors recommend periodic urine drug screening and suggest that random urine drug screens may be more informative than scheduled or routine testing. The guideline section on monitoring (Section 5) states: Page 5 of 10

5.1: Clinicians should reassess patients on COT periodically and as warranted by changing circumstances. Monitoring should include documentation of pain intensity and level of functioning, assessments of progress toward achieving therapeutic goals, presence of adverse events, and adherence to prescribed therapies (strong recommendation, low-quality evidence). 5.2: In patients on COT who are at high risk or who have engaged in aberrant drugrelated behaviors, clinicians should periodically obtain urine drug screens or other information to confirm adherence to the COT plan of care (strong recommendation, lowquality evidence). 5.3: In patients on COT not at high risk and not known to have engaged in aberrant drugrelated behaviors, clinicians should consider periodically obtaining urine drug screens or other information to confirm adherence to the COT plan of care (weak recommendation, low-quality evidence). Clinicians should periodically reassess all patients on COT. Regular monitoring of patients once COT is initiated is critical because therapeutic risks and benefits do not remain static. The American Society of Interventional Pain Physicians (ASIPP) (Manchikanti et al, 2012) Guidelines for Responsible Opioid Prescribing in Chronic Non-Cancer Pain: Part I-Evidence and Part 2-Guidance. ASIPP issued evidence-based clinical practice guidelines to improve the quality of care through responsible opioid prescribing in non-cancer pain. They have described evidence assessment followed in Part 1 of the guidelines and the recommended guidance in Part 2. ASIPP provided 11 recommendations including drug cut-offs and detection limits for drugs of abuse, drug crossreactants, guidance on interpretation of unexpected results for urine drug testing and urine drug testing algorithm. In their algorithm, ASIPP proposed to perform baseline assessment of the patient with chronic pain using POC immunoassay. Then, depending on the result to continue either compliance monitoring with random POC immunoassay in 1-3 months if initial results were appropriate or explained, followed-up with random testing in 6-12 months if the result remains appropriate. In the case when inappropriate or unexplained results are obtained, confirmatory testing is proposed with repeat urine drug testing in one month or next appointment. In their recommendation 1D, level of evidence good, ASIPP stated: Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. Additionally, they stated ( In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. Level of evidence is fair. The Washington State Agency Medical Directors' Group published an Interagency Guideline on opioid dosing for chronic non-cancer pain (AMDG, 2015). This guideline and related expert commentary support low-risk individuals having UDT up to once per year, moderate risk up to 2 per year, high risk individuals up to 3-4 tests per year, and individuals exhibiting aberrant behaviors should be tested at the time of the office visit. The American Pain Society guidelines (Chou et al, 2009) state that for individuals at low-risk for adverse outcomes, quarterly or semi-annual monitoring is sufficient. The risk for abuse may be measured using standard tools, such as the Screener and Opioid Assessment for Patients with Pain (SOAPP) and the Opioid Risk Tool. These types of tools may help clinicians assess the suitability of long-term opioid therapy for chronic pain patients, and may help differentiate those patients who require more or less clinician monitoring while on long-term opioid therapy. Both tools may be self-administered at or prior to an office visit, or completed as part of an interview with a nurse, physician or psychologist. Page 6 of 10

Wisconsin has recently issued the Chronic Opioid Clinical Management Guidelines for Wisconsin Worker s Compensation Patient Care (https://dwd.wisconsin.gov/wc/medical/pdf/chronic%20opioid%20clinical%20managem ENT%20GUIDELINES%20.pdf) accessed on 05/01/2018. They recommended for any worker s compensation patient who will need opioid treatment for a period of more than 90 days, that the treating physician should follow these guidelines and or consider referral to a Pain Management specialist. In their document, they stated that urine drug screening before starting chronic opioid therapy is imperative to verify that patient is not using illegal substances. In addition, according to their guidelines compliance monitoring is mandatory for all patients on chronic opioid therapy with several tools including urine drug screen for the first visit and with aberrant behavior and unannounced urine drug screens thereafter. Urine Drug Testing: Current Recommendations and Best Practices, guidelines from The Texas Pain Society published in 2012 Per American Society of Addictive Medicine (ASAM, 2013), quantification should not be used to determine adherence with a specific dosage or formulation regimen. There are, however, some specific reasons for obtaining quantitative data. For example, when several opioids are present in the urine of a patient prescribed a single opioid, quantification can help the clinician decide whether the presence of the other opioids is consistent with metabolism of the prescribed opioid or with contamination from the opioid manufacturing process, or if more than one drug within a class is being used. As well, in the setting of illicit drug use, serial creatinine-corrected quantitative values can help the clinician distinguish cessation of drug use from continued drug excretion from ongoing drug use. State laws may also guide testing decisions. The American Academy of Family Practice developed recommendations in 2012, Rational Use of Opioids for Management of Chronic Nonterminal Pain (http://www.aafp.org/afp/2012/0801/p252.html accessed06/29/2016) Veterans Administration/Department of Defense VA/DoD Clinical Practice Guidelines for COT: Management of Opioid Therapy for Chronic Pain (2010) http://www.healthquality.va.gov/guidelines/pain/cot/cot_312_full-er.pdf 2018 Laboratory Medicine Practice Guidelines from American Association in Clinical Chemistry (AACC) AACC have published Laboratory Practice Guidelines: Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management in 2018. The main goal of their guidelines was to provide evidence-based recommendations for the use of laboratory and point-of-care (POC) urine drug tests for detection of drugs. AACC s guidelines include 26 recommendations and 7 expert opinions. AACC gave no recommendations for the frequency of testing but stated that more frequent laboratory testing is recommended for patients with a personal or family history of substance abuse, mental illness, evidence of aberrant behavior, or other high-risk characteristics. (Evidence A, II). Authors recommended using other tools available to physicians in addition to urine drug screening for monitoring compliance. Urine drug testing is recommended for detection of drugs in pain management patients (Evidence B, II). Authors prefer and recommend definitive drug testing instead of immunoassays performed on laboratory-based analyzers (Evidence B, II). Also, qualitative definitive tests are recommended over immunoassays because they are more effective at drug identification and have superior sensitivity and specificity (Evidence A, II). POC qualitative presumptive tests offer similar performance characteristics to laboratory-based immunoassays and therefore AACC recommends that physicians use package inserts or consult laboratory personnel to accurately interpret lab results (Evidence B, II). They recommend the use of qualitative Page 7 of 10

immunoassays before prescribing controlled substances to identify illicit drug use in pain management patients (Evidence B, II). AACC stated, First-line definitive testing (qualitative or quantitative) is recommended for detecting the use of relevant over-the-counter medications, prescribed and non-prescribed drugs, and illicit substances in pain management patients (Evidence A, II). They also recommend confirming with definitive testing any immunoassays that are not consistent with clinical presentation of the patient (A, III). Although quantitative definitive urine testing is not more useful than qualitative definitive testing, according to AACC there are advantages to use quantitative definitive testing in certain situations such as: quantitative urine definitive testing is recommended to identify variant drug metabolism, detect pharmaceutical impurities, or metabolism through minor routes. Quantitative results may also be useful in complex cases to determine the use of multiple opioids, confirm spiked samples, and/or rule out other sources of exposure (e.g. morphine from poppy seeds) (Evidence A, II). Authors recommended to use specimen validity testing (eg. ph, temperature, etc.) for urine specimens (Evidence A, I) within 5 minutes at the point of collection using federal workplace cutoffs and the adulterated specimen must not undergo further testing (Evidence A, I). Specimen validity testing should be performed on all urine drug tests for pain management patients (Evidence A, I). In addition, AACC recommended using Quantitative or proportional patterns of some drug and drug metabolites is recommended to explain complex cases and detect: the presence of pharmaceutical impurities, simulated compliance (e.g., adding drug directly to urine), and/or the major route of metabolism in a particular patient (Evidence I, II). Finally, they did not recommend using urine drug testing to approximate the time of last dose (Evidence B, II). Billing/Coding/Physician Documentation Information This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page. Applicable service codes: 80305, 80306, 80307, G0480, G0481, G0482, G0483, G0659 Code Number PA Required PA Not Required Not Covered 80305 X 80306 X 80307 X G0480 X G0481 X G0482 X G0483 X G0659 X Documentation Requirements The patient's medical record must contain documentation that fully supports the medical necessity for drug testing. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included. Scientific Background and Reference Sources ACOG Committee Opinion, At-Risk Drinking and Illicit Drug Use: Ethical Issues in Obstetric and Gynecological Practice. No. 422, December, 2008. Page 8 of 10

ACOG Committee Opinion, Opioid Abuse, Dependence, and Addiction in Pregnancy. No. 524, May, 2012. American Academy of Pain Medicine (2013). Use of Opioids for the Treatment of Chronic Pain A statement from the American Academy of Pain Medicine, March, 2013. Accessed 3.1.2014 at: http://www.painmed.org/patientcenter/position-statements/ American Society of Addictive Medicine (ASAM) (2013).Drug Testing: A White Paper of the American Society of Addictive Medicine. Retrieved online on April 24, 2017 from http://www.asam.org/docs/default-source/public-policy-statements/drug-testing-a-white-paper-byasam.pdf Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492. Chou, R., Fanciullo, G. J., Fine, P. G., Adler, J. A., Ballantyne, J. C., Davies, P., the American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. (2009). Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. The Journal of Pain : Official Journal of the American Pain Society, 10(2), 113 130. http://doi.org/10.1016/j.jpain.2008.10.008 Dowell, D., Haegerich, T.M., & Chou, R. (2016) CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016. MMWR Recomm Rep, 65(No. RR-1):1 49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 Federation of State Medical Boards (2017). Model Policy for the Use of Opioid Analgesics for the Treatment of Chronic Pain. Retrieved online on April 24, 2017 from http://www.fsmb.org/media/default/pdf/fsmb/advocacy/pain_policy_july2013.pdf Manchikanti, L., Abdi, S. Atluri, S. et al (2012). American Society of Interventional Pain Physicians (ASIPP) Guidelines for Responsible Opioid Prescribing in Chronic Non-Cancer Pain: Part 2 Guidance. Pain Physician, 15(3 Suppl):S67-116 National Institute on Drug Abuse (2015), Nationwide trends. Retrieved March 29, 2017, fromhttps://www.drugabuse.gov/publications/drugfacts/nationwide-trends National Survey on Drug Use and Health (2013). Results from the 2013 National Survey on Drug Use and Health: Summary of national findings. Retrieved March 29, 2017, from https://www.samhsa.gov/data/sites/default/files/nsduhresultspdfwhtml2013/web/nsduhresul ts2013.htm#3.1.2 Palmetto GBA, Local Coverage Determination (LCD): Controlled Substance Monitoring and Drugs of Abuse Testing, September 2015. Accessed 9.17.015 at: http://www.palmettogba.com/palmetto/palmetto.nsf/sitehome?readform Washington State Agency Medical Director s Group (2015). Interagency Guideline on Prescribing Opioids for Pain. Retrieved online on April 24, 2017 from http://www.agencymeddirectors.wa.gov/ Jannetto, P. J., & Langman, L. J. (2018). Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. The Journal of Applied Laboratory Medicine: An AACC Publication, 2(4), 471-472. doi:10.1373/jalm.2017.025304 Page 9 of 10

Merskey, H. a. B., A.P. (2011). Part III: Pain Terms, A Current List with Definitions and Notes on Usage. In e. b. H. M. a. N. B. IASP Task Force on Taxonomy (Ed.), Classification of Chronic Pain (Second Edition (Revised) ed., pp. pp 209-214). Seattle, WA: IASP Press. Policy Implementation/Update Information 1/1/19 New policy developed. BCBSNC will provide coverage for opioid testing in pain management and substance abuse when it is determined to be medically necessary because the medical criteria and guidelines are met. Medical Director review 1/1/2019. Policy noticed 1/1/2019 for effective date 4/1/2019. (an) Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits and eligibility are determined before medical guidelines and payment guidelines are applied. Benefits are determined by the group contract and subscriber certificate that is in effect at the time services are rendered. This document is solely provided for informational purposes only and is based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. Medical practices and knowledge are constantly changing and BCBSNC reserves the right to review and revise its medical policies periodically. Page 10 of 10