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Response to Comments: Controlled Substance Monitoring and Drugs of Abuse Testing Comment Period Ending 05/02/2014.


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Response to Comments: Controlled Substance Monitoring and Drugs of Abuse Testing Comment Period Ending 05/02/2014.
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Response to Comments
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Article for Response to comments for Controlled Substance Monitoring and Drugs of Abuse Testing Comment Period Ending 05/02/2014.

Response To Comments

1Delay LCD until AMA CPT new drug testing codes are implemented in 2015.This LCD was originally posted on the Noridian website in December 2013 based on an original draft developed in collaboration with Palmetto GBA (the previous Jurisdiction E contractor). Palmetto GBA proceeded to revise and publish a final version that became effective in December 2014. Noridian chose to delay publication of a final version until the coding became more clear.
2Postpone LCD until additional policies and guidelines recently published on drug testing are assessed and evaluated by all affected parties. The commenter states that multiple updated state guidance documents and regulatory policies should be evaluated and considered by Noridian (in Consultation with Palmetto GBA). In additional, they specify that the National Association of Addiction Treatment Providers (NAATP) guidelines, to be issued later this year, and the American Society of Addiction Medicine’s (ASAM) recent white paper need to be assimilated by the public and all interested stakeholders prior to implementation of the LCD.Noridian (in Consultation with Palmetto GBA) has considered all current publications in its review and will update the policy as needed if additional publications indicate change is needed
3Strongly agree that:
  1. Drug test results obtained from chemistry analyzers must not be billed as confirmatory/definitive tests
  2. Agree with moderate and high complexity test qualifications
  3. Quantitative/definitive testing is performed by
    1. Certified high complexity lab
    2. Lab meets CLIA regulations
    3. Results performed by qualified clinical lab scientists
  4. Quantitation/definitive drug testing is “Reasonable and Necessary”
    1. To confirm positive screening/presumptive results
    2. To identify unsuspected negative screening/presumptive results
    3. When quantitative concentration is necessary to guide medical treatment or management to identify particular drug in large drug class, or
    4. To rule out false positive presumptive results
  5. It is the physician’s duty to order quantitative/definitive testing when medically necessary with proper documentation and order an individual panel for a specific patient.
  6. The appropriate placement of LC-MS/MS technology because of its technological complexity is in independent, high complexity reference labs.
  7. A test requisition for UDT does not require a clinician’s signature. CMS signature requirements for laboratory testing pertain to the patient medical records.
  8. Laboratories do not generally have patient specific information. They only have information that is supplied to them by the referring clinician (diagnoses codes and/or narrative).
    1. Have an order for ever service billed; and
    2. Assure accurate processing of test orders and submission of claims
Comments acknowledged.
4Policy restricts patient access to critical pain medication monitoring services and interferes with a physician’s clinical judgment in managing chronic pain.
  1. Draft policy severely limits the use of available tools to assess the true absence or presence of drug metabolites not detected in presumptive testing;
  2. Physician-partnered labs have the same technology, personnel, and rigorous certification requirements as do reference labs, but additionally provide more immediate testing results.
This policy does not restrict patient access or interfere with a physician’s clinical judgment in managing patients. This policy clarifies the physician’s responsibility to appropriately order drug tests based on clinical findings, risk assessment, drug use history, and other clinical factors as appropriate and document the reason for the testing in the medical record. The policy does cite recommendations established by recognized specialty groups which form the basis for this LCD. The policy describes the established and typical scenarios for the level of testing. As stated throughout the policy, we would expect the provider’s documentation to support the medical necessity of the testing ordered/performed.
5Specimen Validity Testing Multiple commenters urge Noridian (in Consultation with Palmetto GBA) to reverse language in LCD and recognize that SVT is an integral part of the treatment process - that physicians rely on this testing to know whether patients are purposefully or mistakenly adulterating urine samples; that the results are used to make clinical decisions regarding the appropriate course of treatment; that the results are not “quality control issue”; and that POCT does not offer reliable results regarding the validity of specimen”. Provider states that pH, creatinine, and spec gravity are important to identify dilution and substitution, and abnormal results invalidate the sample for the laboratory. Another commenter cites that creatinine identifies purposeful over-hydration or use of diuretics, and results can be normalized to reflect the hydration status. This provider also states that creatinine allows trending of results for drugs that remain in a patient’s system for an extended period. They indicate that oxidants help determine whether the specimen has been tampered with to mask the presence of drugs and that oxidants interfere with test results. Other commenters state that pH and oxidant testing rarely provide actionable results. Another commenter notes that SVT are not a part of POCT. Another commenter states that SVT “tests provide integral diagnostic information relevant to patient hydration and specimen alterations status that is critical to the accurate interpretation of test results”. Without SVT, drug seeking/abusing patients may easily subvert the testing process by diluting or altering specimen to escape drug use detection. These services are necessary to accurately interpret any patient specimen are patient (not test) specific and not included in the valuation of the toxicology codes used by diagnostic laboratories”. “CMS should provide coverage when a treating physician specifically orders SVT testing in addition to quantitative/qualitative drug tests”. SVT is an internal laboratory procedure to determine whether the urine specimen has been diluted or adulterated that also assures and protects the laboratory from reporting invalid test results to the ordering physician. SVT must be performed on every specimen by the laboratory. Multiple commenters stated that “abnormal results invalidate the sample for the laboratory”, “drug seeking/abusing patients may easily subvert the testing process” and “provide integral diagnostic information relevant to patient hydration and specimen alterations status that is critical to the accurate interpretation of test results”. These commenters all recognize that testing relates to specimen integrity and accuracy, and not for direct patient management. SVT results provide information about the integrity of the urine specimen and does not define/establish criteria for a physician to prescribe/non- prescribe pain medication or dismiss a patient, and as such, is not a separately reimbursable Medicare service. In the Guidelines for Federal Workplace Drug Testing Programs, urine specimens collected for Federal workplace drug testing programs may only be tested for the purpose of detecting drug use and to determine the validity of the specimen. This testing is focused at identifying true positives and ruling out false positives. The SVT requirement refers to the “specimen” not the individual or employee tested. The definition for a “negative result” was revised to clarify that the specimen must not only be negative for drugs but must also be a valid urine specimen. This definition states that a “negative result” indicates that a specimen is not only negative for drugs but also that the specimen validity tests conducted on the specimen indicates that the specimen is a valid specimen. For workplace testing, SVT is a mandatory requirement for every specimen and include creatinine, specific gravity, pH and oxidants (73 CRF7 1858). Workplace drug testing, inclusive of SVT, consists of a single comprehensive price/reimbursement. Similar to workplace testing, SVT testing in clinical drug testing applies to the “specimen”, although some labs have attempted to shift the laboratory’s responsibility by allowing physicians to “order” SVT on their test requisition in order to justify individually billing Medicare for the SVT component analytes (pH, specific gravity, oxidants x 2, creatinine). Other labs bill for SVT without a physician’s order. Many labs do not bill for SVT as they fully recognize SVT as a laboratory responsibility. Despite providers who argue that SVT provides directly actionable patient management information, SVT is not a reimbursable service by Medicare.
6LC-MS/MS and GC-MS testing is “Reasonable and Necessary” in physician office setting
  1. Physicians with in-office high complexity labs including LC-MS/MS are equivalent to reference labs. Medicare contractor simply has no authorityto countermand or invalidate the certifications made by CMS in conformance with CLIA rules; Contractor giving preferential treatment to reference labs; contractor failed to provide “strongest evidence available” to justify policy; contractor disagrees with “general acceptance by the medical community”.
  2. The draft LCD would establish site-of-service coverage differentials based on lab ownership that are contrary to and more restrictive than CMS national policy.
  3. No evidence has been presented that justifies the proposed non-coverage policy, thus the policy would discriminate against qualified physician labs even though there has been no documentation of problems regarding the medical necessity of such tests.
  4. The need for faster results to enhance patient care and manage patient prescriptions has prompted physician office and physician-partnered labs to provide LC-MS/MS and GC-MS testing.
  5. Points to consider:
    • No evidence that physician-owned labs are any less accurate than reference labs.
    • In-office physician owned labs are protected by Anti-Kickback Safe Harbors.
    • This policy is anti-competitive.
    • This policy supports the lobbying efforts of large reference labs.
    • If finalized as posted, existing physicians owned or partnered labs should be grandfathered Physician-owned labs undergo the exact same stringent licensing and operate under the exact same regulations as reference labs.
    • At a time when physicians feel under attack, I would make enemies of large groups of physicians and their congressional representatives.
    • Since this policy applies to urine drug testing labs, and not physician-owned genetics testing and blood chemistry testing, my relationship with national reference labs is more transparent.
  6. A Medicare contractor simply has no authority to countermand or invalidate the certifications made by CMS in conformance with CLIA rules.
While some physician’s office labs and physician-partnered labs may meet the CLIA qualification for high complexity designation we do have a concern that some physician practices may have purchased MS instruments from vendors whose “application notes” promote “plug and play” testing without appropriate method development and validation by qualified professionals. We feel the use of “application notes” could put providers at risk for reporting inaccurate test results. Only FDA 510K cleared test methods should be distributed by vendors. While we have removed the specific limitation on POLs, we would expect any lab performing these high complexity tests to continue to perform these tests according to established standards. Noridian (in Consultation with Palmetto GBA)has chosen not to address comments that we have failed to disclose evidence of utilization practices by physician-based and physician-partnered laboratories beyond the fact that it clearly demonstrates a pattern of utilization (frequency and units of service) significantly higher for quantitative testing for physician office-based and physician-partnered labs in comparison to other providers of this service.
7Want to confirm/quantitate all positive and all negative presumptive test results. Multiple providers want to have definitive testing on all negative screening/ presumptive results. They indicate that the policy removes their ability to practice pain management as they choose and goes against some state laws that require confirmation of negative preliminary assays. ASAM notes that definitive testing should be done for specific indications. They specify that “in general, positive IA results need only be subjected to definitive testing when the results conflict with patients’ account of their drug use or when drug specificity is needed in class-specific assays (amphetamines, benzodiazepines, opiates). In a pain practice it is sometimes, but not always, important to identify the specific drug, not just the class of the drug”. ASAM specifies “there is no compelling rationale for subjecting all negative IA results to definitive testing”. While the sensitivity of MS-based technology changes “some analytical false-negative IA results into true-positive definitive results, the clinical value of this additional information must be balanced by the costs associated with its acquisition. However, when the unexpected absence of a prescribed drug on an IA test is at odds with the patient’s account of medication use, definitive testing of the specimen is strongly suggested. In a patient with a history of misuse or substance use disorder, periodic definitive testing of negative IA test results for specific drugs or metabolites is warranted”.
8Risk stratification using subjective and objective tools have limitations:
  1. Self-reporting results in under-reporting.
  2. NIDA-self report is less valid for stigmatized drugs (i.e. cocaine) and for more recent use.
  3. No single validated tool applies for clinical use in chronic pain population.
Risk stratification tools are not a replacement for the practice of medicine. They are tools to assist the physician, in addition to medical history, previous drug test results and use, and clinical finding, in obtaining, assessing and utilizing clinical information.
9Use of laboratory-created or physician-generated panel is a long standing and medically appropriate practice. Some physicians want custom panels on all patients in their practice. A commenter notes that “the use of panels was not prohibited in either the Corporate Integrity Agreements entered into by laboratories with CMS, or the OIG Model Compliance Guidance for laboratories. CMS guided laboratories to ensure that there is adequate choice on requisitions, to ensure full disclosure of all of the components in panels, and to ensure that pricing does not encourage physicians to order panels instead of individual tests. Laboratories should offer a range of choices to physicians”. A commenter notes that “if a particular combination of tests is appropriate for a significant portion of the physician’s patient population, a requisition or electronic ordering solution that provides the physician with a choice of individual tests and medically-justified qualitative panels is entirely appropriate”. Another commenter notes that patient-specific standing orders may be reasonable and necessary depending on the clinical situation. Physicians in a large orthopedic/sports medicine group want custom panels that they “deem medically relevant for every patient." They indicate there would be no difference whether they selected each drug individually or selected a standard custom panel. Removing this option takes away our medical opinion on how to best treat each individual patient.” Noridian (in Consultation with Palmetto GBA)agrees that presumptive panels are acceptable as screening tests because the service is billed on a “per encounter” basis. However, no single definitive panel, regardless of whether the panel is offered by a reference lab or physician-directed, is reasonable and necessary for all patients in a practice at every encounter. The availability of multiple panels with limited numbers of drugs, regardless of whether laboratory-created or physician-directed, allows clinicians the opportunity to select the best panel for a given patient profile, provided the panel does not include unnecessary tests. Panels with limited numbers of drugs, and individually listed drugs on a test requisition, allows the physician to truly customize definitive testing for a given patient without unnecessary testing or cost to the healthcare system.
10Modify draft LCD to provide Medicare coverage for LC-MS/MS as a stand-alone (direct to LC-MS/MS) test to improve the health of Medicare beneficiaries. Drug testing should be random, with comprehensive testing, with defined maximum frequency for reimbursement Allow definitive panel of “40 or more drugs” and reimburse at flat rate per encounter. The “draft LCD should not rely on IA technology alone as an appropriate drug testing methodology and should more clearly permit and encourage the use of LC-MS/MS as a stand-alone test and as definitive testing after an initial IA screen”. The commenter notes that “IA methods in the office setting is a behavioral tool to maximize the effects of substance use treatment, or for generating presumptive tests results for the purpose of immediate prescribing of pain medications pending definitive testing. IA methods are woefully inadequate when used for the purpose of accurately determining whether and how patients are abusing or misusing drugs or whether they are taking multiple medications which may interact with opioids, leading to negative outcomes”. The commenter notes that “in pain treatment, if clinicians are not testing false negatives, they will continue to prescribe controlled medications resulting in potential duplication of certain types of drugs, prescribe drugs for a patient who is taking an illicit substance, or prescribe medications that may interact with other medications, all of which could ultimately increase risk for patient distress or death.” A number of commenters strongly suggested establishment of a “G” code that provides coverage for confirmatory/definitive LC-MS/MS panels with a flat rate per encounter. Commenters indicate that regardless of whether one or more specific definitive tests are ordered, LC-MS/MS technology permits identification of a large number (>40) of drugs/metabolites during the run, sometimes significant drugs/metabolites are identified and the results must be provided to the physician. A single code with a single reimbursement rate would provide definitive results to physicians that need to know and eliminate overutilization and fraud. LC-MS/MS technology allows comprehensive definitive confirmation of roughly 40 or more drugs, metabolites and illicit drugs in a single run. A single definitive confirmatory panel of drugs and metabolites, with or without prior presumptive testing, offers a cost effective means to provide comprehensive drug results given the fact that unsuspected drugs/metabolites are identified in upward of 40% of urine specimens. Neither the existing nor the proposed AMA CPT codes provide for a single code for a comprehensive definitive confirmatory panel (CDDP) and at the current time, CMS does not recognize a comprehensive confirmatory panel. To allow providers to unbundle the service and bill individual definitive codes would result in significant over-payment that itself is not reasonable and necessary. Laboratories offering comprehensive definitive testing should notify their respective Medicare Administrative Contractors (MAC) to establish the correct coding (i.e. NOC) and to establish reimbursement. Drug testing frequency is patient specific and in compliance with generally recommended pain management and addiction treatment guidelines as set forth in this policy.
11Need to add CPT 83789; and add ICD-9s.CPT 83789 and submitted ICD-9s have been added to the policy.
12Reflex Testing A commenter asked for clarification regarding presumptive testing that reflexes to definitive testing without further contact from the referring physician for positive presumptive results, or when the presumptive test provides an unexpected negative for a prescribed pain medication. When urine specimens are submitted to reference labs for testing, it is customary to reflex positive presumptive test results to definitive testing, or for unexpected negatives when prescribed medication is listed on the test requisition without further contact from the ordering physician due to logistical reasons. However, when presumptive testing is performed in a clinician’s office lab, and definitive testing is performed either by a physician’s lab or reference lab, it is expected that the physician is directly involved in determining the clinical appropriateness for all subsequent definitive testing, and documents the necessity in the patient’s medical record.
13Repetitive IA testing by physician and reference labSome office practices test for a presumptive panel and submit the specimen to a reference lab for additional IA tests that were not in the clinician’s presumptive panel. However, IA testing may only be billed once for the same service, so the reference lab may not be reimbursed for their additional IA testing. The date of service of the test is the date the specimen was collected and must never be changed simply to avoid denial as duplicative testing.
14Medication assisted addiction treatment such as Suboxone. A commenter inquired whether patient monitoring for medication assisted addiction treatment such as Suboxone was considered Group B or Group C. Suboxone, a combination of buprenorphine and naloxone, is used to treat narcotic (opiate) addiction. It is not for use as a pain medication. Consequently, it would be considered in Group B.

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