Compliance Perspectives: Drugs-of-Abuse Testing: Noridian DL34754 Raises Critical Compliance, Legal Issues for Clinical Labs

Testing for drugs of abuse in clinical practice is a balancing act for the laboratory and health care practitioner. Testing too few or too many drugs or testing too frequently or not frequently enough may have significant financial and legal consequences. Choosing between test methods is also a balancing act, and some methods have demonstrable utility in clinical practice while others are better suited to performance by an independent clinical laboratory. The clinical laboratory’s ability to achieve balance is related directly to its approach to and understanding of coverage determinations and applicable regulatory material on the need for testing. Failure to consider these issues may significantly impact the laboratory’s financial and legal viability and expose it to health care audits and investigation for fraud and abuse, among other potential charges and legal actions. MAC Attack (or Well-Coordinated Effort to Level the Playing Field?) Recently released draft local coverage determinations (LCDs) by Medicare administrative contractors (MACs) Noridian Healthcare Services (NHS, formerly Noridian Administrative Services) and Palmetto GBA (J11) signal the federal government’s intent to provide more structure to coverage decisions associated with drugs-of-abuse testing.¹ These draft LCDs seem coordinated and foretell additional system edits and provide guidance to audit and investigative personnel on where to look for trouble. Earlier LCDs for drugs-of-abuse testing lacked consistency and were almost devoid of helpful detail on medical necessity; they simply overlooked the importance of drugs-of-abuse testing in chronic pain management and circumvented testing frequency issues in chemical detoxification treatment. The recent NHS and Palmetto draft LCDs derive from the collective Medicare audit experience, including findings associated with Zone Protection Integrity Contractor audits and recent U.S. Department of Justice prosecutions of clinical laboratories, laboratory management, and health care practitioners. This article is not intended to involve a detailed analysis of DL34754 but contains a discussion of a few important compliance and legal challenges associated with the policy. Readers should consider these issues in light of their laboratory’s overall platform for drugs-of-abuse testing and seek clarification from a qualified health care attorney and industry compliance consultants. DL34754 is not part of a MAC attack to rid clinical laboratory from the health care system or to eliminate definitive testing following screening, but the policy does appear to hit the mark as the start of a well-coordinated effort by the MACs to level the playing field in clinical laboratory for drugs-of-abuse testing. DL34754 NHS is a MAC for jurisdiction E. On Jan. 7, 2014, NHS published DL34754 (titled “Drugs of Abuse Testing”). DL34754 contains significant new coverage guidance, and NHS recently extended the comment period for DL34754 from March 14, 2014, to May 2, 2014. DL34754 recognizes that drug testing is a clinical tool allowing practitioners to evaluate and monitor patient risk potentials for (1) overdose, drug-drug interaction, and toxicity in the emergency setting; (2) abstinence, new problems, and relapse in the substance abuse treatment setting; (3) developing drug abuse or misuse problems in the chronic opioid therapy setting; and (4) adherence to treatment plans involving the use of controlled medication. DL34754 fairly recognizes there is significant financial cost to the health care system when testing is not performed correctly or at all. DL34754 is intended to minimize overpayments to those who order medically unnecessary drug testing. DL34754 covers drugs-of-abuse testing for Medicare patients; it does not cover neonatal testing for suspected prenatal drug exposure. Unlike past LCDs, DL34754 provides a detailed “overview of distinctions between qualitative, confirmation and quantitative drugs of abuse testing, and clearly indicates that coverage is dependent on proper documentation of clinical decision-making and test orders that are tailored to the individual patient’s medical needs.” DL34754 makes it very clear that drug testing is useful in the clinical setting (at the point of care) because it may provide objective information to assist the provider in diagnosing and making treatment decisions. DL34754 lists coverage indications for qualitative drug screening in the clinical setting and for quantitative and confirmation testing when used to definitively answer questions directly relevant to the individual patient’s care situation. Wholesale retesting of qualitative screening results will not be covered and examples are provided. DL34754 establishes basic parameters for test methods, test panels, and specimen type. NHS believes drugs-of-abuse testing “should only be ordered and performed on a patient/drug specific basis, within the parameters outlined in [DL34754] and documented in the patient record.” This is not a new requirement. Earlier LCDs and the Office of Inspector General’s (OIG) Compliance Program Guidance for Clinical Laboratories both contain directives for individualized laboratory testing.² Clinical correlation between the individual patient record and the nature and the frequency of the testing ordered is a must for coverage. The connection between the test order and clinical decisionmaking following test results must be reasonable and medically necessary to the ongoing care of the patient. Drug Test Panels “No single drug panel is suitable for all clinical uses, and test options should be adapted to clinical needs through proper exercise of clinical decision-making.”³ Laboratory personnel should eliminate opportunities for health care practitioners to routinely order comprehensive drug panels without regard to the individual patient or clinical utility. For example, the routine testing of PCP, Ecstasy (MDMA, MDA, etc.), and barbiturates may present a coverage problem under DL34754. Of course, this does not mean that one should never test for these drugs, but the example offers insight into NHS’s position. Test menus should consider the “demographics of drugs abused in a particular geographic area.” Test forms should allow health care practitioners to identify the patient’s current prescribed medication, document the results of any qualitative screening, and provide a fairly obvious connection between the drugs prescribed, the drugs to be tested, the test results, and the ongoing treatment plan. Test utilization monitoring is very important, and DL34754 is a natural extension and modernization of the OIG’s guidance encouraging clinical laboratories to educate physicians about proper test ordering. Laboratories must market drug test assays based on demonstrable clinical utility rather than reimbursement value. It is not reasonable to expect that any health plan cover and reimburse custom panel testing just because the drugs might potentially be abused or because broad test panels offer maximum legal protection to the health care practitioner against claims of inappropriate prescribing. Reasonable compliance efforts may offer some protection against a claim of specific intent to defraud a payer and may be useful in other forms of negotiation with payers. DL34754 is clear: Medicare intends to exclude “routine use” of test panels and may deny claims for reimbursement when documentation does not tie the drugs tested to the Medicare beneficiary’s medical situation. Specimen Type DL34754 states urine is the preferred specimen and may be the “best source for broad qualitative drugs of abuse testing because blood is relatively insensitive for common drugs such as psychotropic agents, opioids, and stimulants.” DL34754 also acknowledges potential “clinical value in the limited use of other specimen types, such as saliva and serum, so long as clinical rationale therefore is clearly stated.” Stakeholders should work together to understand when urine is an appropriate specimen for drugs-of-abuse testing and when other specimen types may produce test results with higher clinical utility. Presently, there is no way to differentiate urine from other specimen types in claims (the Current Procedural Terminology allows for any specimen except breath or as otherwise indicated in the code descriptor). Thus, payers may seek documentation to ensure a valid claim. DL34754 preserves the long-standing Medicare decision to exclude from coverage “the testing of two different specimen types from the same patient on the same date of service.” More than payment is at stake for violations of these coverage limitations, and attempts to circumvent specimen type boundaries to increase test orders may be viewed as fraud. Clinical laboratories should explore this area carefully with legal counsel. Specimen Validity Testing DL34754 excludes specimen validity testing (SVT) from coverage because Medicare views it as a quality control measure. This is a matter of heated debate in the clinical laboratory community. Palmetto GBA’s DL34398 contains the same exclusion. NHS believes various aspects of specimen validity can be determined at the point of care and should not be left to the independent laboratory as part of confirmation or other definitive testing. This can be understood when a urine sample lacks a normal temperature just after collection or is off-color, suggesting possible adulteration or dilution. SVT is probably not an issue for other specimen types, such as saliva and serum, because the health care provider in effect performs an observed collection. Urine specimen collection, however, may not be observed, allowing patients the opportunity to adulterate, substitute, or tamper with their urine sample. Clinical laboratories argue that SVT is more than a quality control measure for urine drug testing. Clinical laboratories are in the best position to offer comments on SVT to NHS and should support submissions with validated clinical studies. Clinical laboratories would do well to recognize that NHS appears to believe that SVT is a quality control measure used to determine whether a urine specimen should be tested. In other words, if a specimen is not valid, it should not be tested, and test results based on invalid samples should not be billed because they are not medically necessary. Why not simply report to the provider that the specimen was “invalid” and not tested? Homework Clinical laboratories must be familiar with coverage decisions that impact the jurisdictions within which they operate. Clinical laboratories should also review state professional licensing board guidelines and rules governing health care practitioners who operate in the substance abuse treatment and pain management communities,⁴ and use these materials to support provider education on the frequency and nature of drugs-of-abuse testing in these patient populations. Clinical laboratories should attempt to reconcile any differences between testing frequencies and specific test panel requirements using coverage decisions and state regulatory materials. The reconciliation process should examine the potential for legal liability for both over- and underutilization of clinical laboratory services. Clinical laboratories may also want to:

1. Identify professional organization and society materials, such as consensus documents, guidelines, and position statements, about the role of drugs-of-abuse testing in clinical settings.
2. Review the OIG Compliance Program Guidance for Clinical Laboratories.
3. Review testing policies and protocols with laboratory and medical provider staff. This step can help minimize the potential for whistleblower efforts and misunderstandings about the need for and scope of drugs-of-abuse testing. Review periodically to ensure any compliance program remains current with the changing clinical and regulatory landscape.
4. Engage payer representatives, state licensing board officials, and law enforcement representatives in dialogue about the resources supporting their published position.
5. Keep a due diligence file that supports all of the laboratory’s compliance efforts to submit only medically necessary and reasonable claims for reimbursement.

Summary While imperfect, DL34754 represents progress in the battle for balance in drugs-of-abuse testing. Balance is achieved when drugs-of-abuse testing is targeted to the individual patient and test results are well-documented and properly used in the clinical setting to support ongoing treatment decisions, such as the continued use of opioids for pain management. Balance also means an awareness of which test methods are acceptable for the clinical setting. Some test methods enable the health care provider to make basic and timely treatment decisions, such as whether to provide the patient with a controlled substance prescription at that visit or whether to refer the patient to a facility for detoxification. Other test methods are more appropriate for the independent clinical laboratory setting because they require more sophistication in instrumentation or testing processes. DL34754 makes these points. Achieving balance here is no easy task, but it is part of creating a sustainable path forward. Clinical laboratories should seek the input of qualified health law counsel and compliance consultants to address concerns with DL34754. Expect more LCDs and related billing and coding articles this year on drugs-of-abuse testing. Stay current. Clinical laboratories will benefit from new coverage policies, as they will help level the playing field for all stakeholders and, most importantly, the patients who need clinical laboratory services as part of a quality health care package. Jennifer Bolen can be reached at jbolen@legalsideofpain.com or 865-368-3472. 1. NHS DL34754 and Palmetto GBA DL34398. 2. See First Coast Service Option’s MAC-Part B LCD 30574 (2009 and 2010), available online through the CMS Medicare Coverage Database. See also the OIG Compliance Program Guidance for Clinical Laboratories, available online at http://oig.hhs.gov/authorities/docs/cpglab.pdf. 3. DL34754. 4. Several states, including Georgia, Kentucky, and Tennessee, have pain clinic registration acts accompanied by requirements for drug testing policies and testing frequencies. Some state professional licensing boards have recently broadened practice guidelines and rules for substance abuse treatment (office- based treatment of opioid addiction) and chronic pain management to include specific directives regarding the use of drug testing in clinical practice.