2015 Annual Physician Notice

Transcription

1 0 Annual Physician Notice The Office of Inspector General (OIG) recommends clinical laboratories send notices to physicians and other providers who use their services, at least once a year, to inform the recipients of the laboratory s policies for test ordering and billing and provide certain other information regarding the laws and regulations that govern laboratory services. This Annual Notice is provided pursuant to that recommendation. The following information is intended to promote awareness of federal regulations and to explain the requirement for physicians to furnish appropriate documentation when ordering testing services. If you have questions about the contents in this notice, we encourage you to contact us for more information. Medical Necessity: Medicare will only pay for tests that meet the Medicare coverage criteria and are medically necessary for the diagnosis or treatment of the individual patient. Criteria to establish medical necessity for drug testing must be based on patient-specific elements identified during the clinical assessment and documented by the clinician in the patient s medical record. Tests used for routine screening of patients without regard to their individual need are not usually covered by the Medicare Program, and therefore are not reimbursed. As a participating provider in the Medicare Program, Millennium Health (Millennium) has a responsibility to make a good faith effort to ensure all tests requested are performed and billed in a manner consistent with all federal and state law regulations. As the physician, you are responsible for documenting medical necessity in the patient s permanent medical record and for providing appropriate diagnostic information in the form of ICD 9 codes to the highest level of specificity or a narrative to Millennium. The Office of Inspector General takes the position that a physician who orders medically unnecessary tests for which Medicare or Medicaid reimbursement is claimed may be subject to civil penalties under the False Claims Act. Earlier this year, we sent a communication introducing a documentation tool and describing recent policy changes and Health Plan actions, including increased use of post-payment audits, to more aggressively enforce long-standing policies that patients medical records must include documentation of medical necessity for ordered tests. The tool was developed with expert input to assist you with documenting key elements of ordering and implementing definitive testing into patient-specific treatment plans. It should supplement, rather than replace, other forms of documentation and notes you currently utilize. A copy of this communication and the documentation tool can be found on our website at Medicare National and Local Coverage Determinations: The Medicare Program publishes National Coverage Determinations (NCDs) and local Medicare contractors publish Local Coverage Determinations (LCDs) for certain tests. These policies identify the conditions for which the included tests are or are not covered or reimbursed by Medicare with reference to specific ICD 9 codes (diagnostic information). As of January 0, neither Millennium s local Medicare carrier nor the national Medicare program has published a coverage determination relevant to the tests Millennium offers. However, some other local Medicare contractors have issued LCDs that apply to qualitative drug screens (presumptive tests), and confirmatory or quantitative drug tests (definitive testing) furnished within their region of jurisdiction. These policies can be found through the Medicare website at: Millennium also will make these LCDs available to any interested physician upon request. 1 copy or distribute without express written permission from Millennium Health, LLC. MLI-ADF001 Millennium Health, LLC /0

2 Particularly noteworthy is a December 0 LCD issue by Palmetto GBA Medicare entitled Controlled Substance Monitoring and Drugs of Abuse Testing (L35105). This policy is available on the Palmetto / CMS website (see link below*) and, among other things, provides guidance regarding appropriate indications and expected frequency for Urine Drug Testing (UDT) for the safe management of prescribed controlled substances in chronic pain and/or in identifying and treating substance use disorders. *Link: metto+gba+(0%c+mac+-+part+b)&doctype=active&lcntrctr=3*1&bc=agacaaiaaaaaaa%3d%3d& Presently, this policy is applicable only to laboratories located in Palmetto GBA s jurisdiction, which encompasses North Carolina, South Carolina, Virginia and West Virginia, and thus is NOT applicable in Millennium s Medicare coverage jurisdiction, regardless of the location of the ordering clinician. However, we believe many of the requirements included in this LCD eventually will be adopted by the individual CMS contractors nationwide, and thus are preparing to ensure both our and your compliance with the Palmetto standards, including through revised test requisition forms and the documentation tool mentioned above. Test Ordering: A standard Millennium test requisition form should be used when ordering tests. This requisition is designed to emphasize physician choice and encourage physicians to order only those tests which the physician believes are appropriate and medically necessary for the diagnosis or treatment of each patient. The requisition also contains important information regarding how the various tests we offer are performed and billed. If Millennium receives a test order on a non Millennium requisition form or an incomplete Millennium requisition form, processing of your test order may be delayed. As necessary, Millennium will contact physicians to have them resubmit the test order on a Millennium test requisition form or otherwise clarify each specific test being ordered. Physician Custom Profiles: Recent policy changes from Medicare Administrative Contractors outside of our jurisdiction, including the Palmetto LCD highlighted above, support a growing movement away from physicians use of non-patient specific custom profiles when ordering laboratory drug testing. We support these efforts to help better ensure that only medically necessary tests are ordered for each patient and we are taking steps to further the interests of both our clinician and health plan customers. As of April 1, 0, we are no longer accepting any custom profile test orders from healthcare providers in select states, including Massachusetts and California, and expect to implement the same changes across a broader geography in the coming months. In the meantime, we encourage physicians who presently use Custom Profiles to consider making the transition to ordering all testing via individual requisitions. Non-Custom Profile test requisition forms may be obtained from your Millennium representative upon request. For those physicians who have established Custom Profiles, on an annual basis we require you to review and submit a new Custom Profile, noting your changes or renewing the Custom Profile in its current state. Also, you may amend your Custom Profile at any time. We ask that you review your Custom Profile and contact us immediately should there be any mistakes so that they may be corrected. We also suggest that you keep a copy of the Custom Profile readily available when ordering laboratory test services as a reference to help ensure that only medically necessary tests are ordered. We also suggest that physicians routinely review their Custom Profiles to ensure they continue to reflect the testing needs of their patients. copy or distribute without express written permission from Millennium Health, LLC. MLI-ADF001 Millennium Health, LLC /0

3 Verbal Test Orders: Medicare regulations require that all orders for laboratory tests be in writing. If a physician or his/her authorized representative orders a test by telephone or wishes to add a test to an existing order, a written order is required to support the verbal order. In these cases, Millennium will send a confirmation of the verbal order request to the ordering physician, requesting it to be signed and sent back to the laboratory for its records. Testing will not be performed until the signed confirmation or a properly completed Millennium requisition form is returned to the laboratory. Patient Privacy (HIPAA): Under the Health Insurance Portability and Accountability Act (HIPAA), Millennium is a health care provider and a covered entity. It is our policy to comply with the letter and intent of the HIPAA privacy and security standards. Our privacy policy is available at Inducements: Federal law prohibits offering or paying any remuneration meaning anything of value to induce the referral of tests that are covered by Medicare, Medicaid or other federal health care programs. Any form of kickback, payment or other remuneration that is intended to secure the referral of federal health care program testing business is strictly prohibited and should be reported to the Millennium compliance hotline by calling Clinical Consultants: Physicians and other clinicians authorized to order tests have the services of clinical consultants and toxicologists available to ensure proper test ordering and answer questions. They may be reached at (866) Prohibited Referrals: It is the policy of Millennium Health to comply with all aspects of the laws and regulations governing physician self referral, most notably including the federal Stark law. The Stark law s self referral ban states that if a financial relationship exists between a physician (or an immediate family member) and a laboratory (or certain other kinds of healthcare providers), and the relationship does not fit squarely into one of the law s exceptions, then (a) the physician may not refer Medicare patients to the laboratory, and (b) the laboratory may not bill Medicare for services referred by the physician. The kinds of relationships between laboratories and physicians that may be affected by these laws include the lease or rental of space or equipment and the purchase of medical or other services by a laboratory from a referring physician. Medicare Rates: Millennium s test list with CPT and HCPCS G Codes and Calendar Year 0 Medicare maximum reimbursement rates for each test is attached hereto as Exhibit 1. The Notes section to Exhibit 1 and each Millennium test requisition form also contains information regarding how particular tests and test combinations are billed to third party payers. Financial Assistance Programs: Millennium understands that providing quality patient care has a related cost, which in some situations may be burdensome for patients and result in some patients avoiding certain necessary services because they are concerned about the expense. Millennium is committed to delivering the best patient care to all, and to meet this objective has established a financial support program. This financial support program helps ensure affordable access to Millennium s services. Patients with special financial needs may be eligible for support to help defray some of Millennium s testing costs. Millennium encourages those patients who may not be able to pay fully for Millennium s services to contact us for an assessment of eligibility for financial support in accordance with federal guidelines. 3 copy or distribute without express written permission from Millennium Health, LLC. MLI-ADF001 Millennium Health, LLC /0

4 Urine Test List Drug Class Description EXPIRED 0 AMA CPT Code Presumptive Screen- AMA CPT Code (CMS G-code) Alcohols ALCOHOL copy or distribute without express written permission from Millennium Health, LLC. MLI-ADF001 Millennium Health, LLC /0 Notes 8 Definitive Quantitative Test - CPT Codes Definitive Quantitative Test- CMS HCPCS G-Codes 8030 G600 $.70 Temporary CMS HCPCS Code 0 Reimbursement ACETAMINOPHEN EIA AMPHETAMINES 85 METHAMPHETAMINE 85 PHENTERMINE 85 - BARBITURATES /10 /10 13 Test Method ENZYME ASSAY 803 G60 $1. LC-MS/MS 803 G60 $1. LC-MS/MS $.58 LC-MS/MS Barbiturates PHENOBARBITAL $.58 LC-MS/MS Barbiturates SECOBARBITOL G603 $.58 LC-MS/MS Barbiturates BUTALBITAL G603 $.58 LC-MS/MS Benzodiazepines;1 to 1 BENZODIAZEPINES 80 Buprenorphine BUPRENORPHINE 8395 NOS NOS Skeletal Muscle Relaxants; 1 to 3 to 5 NOS; to 6 /7 / G6031 $5.17 LC-MS/MS 8038 G6056 $6.8 LC-MS/MS BUPROPION $.58 LC-MS/MS VENLAFAXINE $.58 LC-MS/MS CARISOPRODOL CITALOPRAM 85 - DULOXETINE 85 - FLUOXETINE 85 - PAROXETINE 85 - n/a CLOZAPINE OLANZAPINE 85 - QUETIAPINE 85 - RISPERIDONE 85 - ARIPIPRAZOLE 85 - HALOPERIDOL Cocaine COCAINE 850 Alcohol Biomarkers; 1 to ETHYL GLUCURONIDE 85 n/a G605 $3.98 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS $5.17 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS $19.8 EIA LC-MS/MS $.58 LC-MS/MS G60 $0.6 LC-MS/MS $.58 LC-MS/MS Fentanyl s FENTANYL G6056 $6.8 LC-MS/MS Gabapentin, non-blood GABAPENTIN $18.0 LC-MS/MS

5 Heroin Metabolite HEROIN 8395 Ketamine and Norketamine Methylenedioxyamphetamines G6058 $18.03 LC-MS/MS KETAMINE $.58 LC-MS/MS MDMA n/a Methadone METHADONE or MEPERIDINE 8395 NALOXONE - - NALTREXONE 85 - DEXTROMETHORPHAN (DXM) Methylphenidate METHYLPHENIDATE n/a - / G60 $1. LC-MS/MS G6053 $. LC-MS/MS 8036 G6056 $6.8 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS $.58 LC-MS/MS G6056 $6.8 LC-MS/MS $.58 LC-MS/MS Methylphenidate RITALINIC ACID $.58 LC-MS/MS Alkaloids; not elsewhere specified Alkaloids; not elsewhere specified 1 or more 1 or more 1 or more MITRAGYNINE ALKALOID (KRATOM) NICOTINE OPIATES G601 $0.85 LC-MS/MS CODEINE/MORPHINE HYDROCODONE HYDROMORPHONE Oxycodone OXYCODONE 8395 Phencyclidine PHENCYCLIDINE 8399 / / G6055 $3.3 EIA G6056 $6.8 LC-MS/MS G605 $8.10 LC-MS/MS G606 $3.98 LC-MS/MS G6056 $6.8 LC-MS/MS $18.99 LC-MS/MS Pregabalin PREGABALIN $.58 LC-MS/MS Synthetic; 1 to 3 Synthetic; to 6 Synthetic; 7 or more SYNTHETIC CANNABINOIDS (SPICE) single drug $.58 LC-MS/MS n/a $.58 LC-MS/MS n/a $.58 LC-MS/MS Tapentadol TAPENTADOL G6056 $6.8 LC-MS/MS Tramadol TRAMADOL 85 Tricyclic and other cyclicals: Skeletal Muscle Relaxants: Tricyclic and other cyclicals: Tricyclic and other TRICYCLIC ANTIDEPRESSANTS AMITRIPTYLINE 80 - CYCLOBENZAPRINE 85 - DESIPRAMINE IMIPRAMINE $.58 LC-MS/MS G6030 $.36 LC-MS/MS $.58 LC-MS/MS G603 $3. LC-MS/MS G6036 $3. LC-MS/MS EIA EIA 5 copy or distribute without express written permission from Millennium Health, LLC. MLI-ADF001 Millennium Health, LLC /0

6 cyclicals: Tricyclic and other cyclicals: natural Sedative Hypnotics (non benzodiazepines) Drug(s) or substances, definitive, qualitative or quantitative, NOS; 1-3 NORTRIPTYLINE THC (CANNABINOIDS) 85 ZOLPIDEM 85 VALIDITY TESTING G6037 $18. LC-MS/MS 8039 G6058 $18.03 LC-MS/MS $.58 LC-MS/MS CREATINE (CHEMICAL) $7.0 EIA ph $.87 EIA SPECIFIC GRAVITY $3.06 EIA NITRITE $9.5 EIA CATHINONES (BATH SALTS) PREGANCY SCREEN beta hcg $.58 LC-MS/MS n/a n/a n/a $10.3 EIA Oral Fluid Test List Drug Class Description EXPIRED 0 AMA CPT Code Benzodiazepine s;1 to 1 AMPHETAMINES 85 METHAMPHETAMIN E 85 BENZODIAZEPINES 80 Buprenorphine BUPRENORPHINE 8395 Presumptive Screen- AMA CPT Code (CMS G-code) 6 copy or distribute without express written permission from Millennium Health, LLC. MLI-ADF001 Millennium Health, LLC /0 Notes /10 /10 /7 /3 Definitive Quantitative Test AMA CPT Codes Definitive Quantitativ e Test- CMS HCPCS G-Codes Temporary CMS HCPCS Code 0 Reimbursemen t Test Method 803 G60 $1. LC-MS/MS 803 G60 $1. LC-MS/MS 8036 G6031 $5.17 LC-MS/MS 8038 G6056 $6.8 LC-MS/MS Skeletal Muscle Relaxants; 1 to CARISOPRODOL G605 $3.98 LC-MS/MS Cocaine COCAINE G60 $0.6 LC-MS/MS Fentanyl s FENTANYL G6056 $6.8 LC-MS/MS Heroin HEROIN 8395 Metabolite G6058 $18.03 LC-MS/MS Methylenedioxy MDMA n/a -amphetamines G60 $1. LC-MS/MS Methadone METHADONE G6053 $. LC-MS/MS Opioids and opiate MEPERIDINE 8395 / 8036 G6056 $6.8 LC-MS/MS OPIATES EIA G6056 $6.8 LC-MS/MS 1 or more CODEINE/MORPHINE HYDROCODONE G605 $8.10 LC-MS/MS

7 1 or more 1 or more HYDROMORPHONE Oxycodone OXYCODONE 8395 Phencyclidine PHENCYCLIDINE 8399 Tramadol TRAMADOL 85 natural THC (CANNABINOIDS) G606 $3.98 LC-MS/MS G6056 $6.8 LC-MS/MS $18.99 LC-MS/MS $.58 LC-MS/MS 8039 G6058 $18.03 LC-MS/MS Pharmacogenetics Test List Drug or Drug Class Drugs Targeted Genes Evaluated CPT Code 0 Medicare Payment Test Method Addiction Methadone CYPB6 879 TBD Naltrexone OPRM1 879 TBD Anticoagulants Warfarin CYPC9, VKORC1 817 $ TBD Anticonvulsants Carbamazepine, Eslicarbazepine, HLA-B*: $18.71 Forphenytoin, Lamotrigine, Oxcarbazepine, Phenytoin Citalopram,, Escitalopram, Sertraline, CYPC19, 815 $91.07 SSRIs/SNRI Fluoxetine, Paroxetine, Venlafaxine, CYPD6 816 $50.6 Vortioxetine L-methylfolate MTHFR 8191 $59.0 Tricyclic (TCA) Amitriptyline, Clomipramine, Doxepin, Imipramine, CYPC19, CYPD $91.07 $50.6 Desipramine, Nortriptyline CYPD6 816 $50.6 Antipsychotics Aripiprozole, Haloperidol, Risperidone CYPD6 816 $50.6 Clozapine, Olanzapine, Risperidone DRD 879 TBD Clozapine, Olanzapine HTRC 879 TBD ADHD Therapy Atomoxetine CYPD6 816 $50.6 Benzodiazepines Diazepam UGTB 879 TBD Lorazepam, Oxazepam CYPC $91.07 Muscle Relaxants Carisoprodol CYPC $91.07 NSAIDs Celecoxib CYPC9 817 $17.6 Opioids Codeine COMT, CYPD6, 879 TBD OPRM $50.6 TBD Fentanyl CYP3A, CYP3A5, OPRM Hydrocodone, Oxycodone, Tramadol CYPD6 816 $50.6 Methadone CYPB6 879 TBD Morphine OPRM1, COMT 879 TBD 879 Platelet Inhibitors Clopidogrel CYPC $91.07 TBD TBD TBD 7 copy or distribute without express written permission from Millennium Health, LLC. MLI-ADF001 Millennium Health, LLC /0

8 Billing Information Notes: (1) This option offers specific drug identification by a single definitive LC-MS/MS test. There is no initial qualitative/presumptive immunoassay screen or second confirmatory test by an alternative method. Except where noted, each separate drug tested is billed separately with the relevant CPT or HCPCS code. This testing should be ordered ONLY if the health care provider deems it necessary when no qualitative immunoassay test is available or where qualitative immunoassay testing alone will not provide the needed information. () Definitive LC-MS/MS test includes codeine, morphine, hydromorphone, and hydrocodone billed as a single unit with CPT 80361; or for HCPCS payers, as codeine and morphine billed as a single unit (G6056), hydromorphone (G606) and hydrocodone (G605) each billed separately. (3) Definitive LC-MS/MS test includes buprenorphine and norbuprenorphine billed as a single unit with CPT 8038 or HCPCS G6056. () Definitive LC-MS/MS test billed as a single unit with CPT 8036 for opioids/opiate analogs (including: dextromethorphan, meperidine, naloxone or naltrexone) and with CPT for 3 or opioids/opiate or for HCPCS payers, as dextromethorphan (85), meperidine (G6056), naloxone (G6056) and naltrexone (85) each billed separately. (5) Definitive test includes oxycodone and oxymorphone billed as a single unit with CPT or HCPCS G6056. (6) Definitive LC-MS/MS test includes butalbital, phenobarbital and secobarbital billed as a single unit with CPT 8035; or for HCPCS payers, as butalbital (G603), phenobarbital (8018) and secobarbital (G603) each billed separately. (7) Definitive LC-MS/MS test includes alprazolam, clonazepam, diazepam, lorazepam, oxazepam and temazepam billed as a single unit with CPT 8036 or HCPCS G6031. (8) Alcohol testing is performed as an enzyme assay and is billed as single unit with CPT or HCPCS G600. (9) Definitive LC-MS/MS test includes multiple spice analytes (see for a complete listing) billed as a single unit with CPT 8035 or HCPCS 85. (10) Definitive LC-MS/MS test includes amphetamines and methamphetamine billed as a single unit with CPT 803 or HCPCS G60. () Definitive LC-MS/MS test billed as a single unit with CPT for antidepressants (tricyclic and other cyclicals class) or with CPT for 3 to 5 antidepressants (tricyclic and other cyclicals class); or for HCPCS payers, as amitriptyline (G6030), desipramine (G603), imipramine (G6036), and nortriptyline (G6037) each billed separately. (1) Definitive LC-MS/MS test billed as a single unit with CPT 8033 for antidepressants (serotonergic class) or with CPT for 3 to 5 antidepressants (serotonergic class); or for HCPCS payers with HCPCS 85 for each antidepressant (serotonergic class) test ordered. (13) Definitive LC-MS/MS test for phentermine billed as a single unit with CPT 803 or HCPCS 85. If ordered with amphetamine and methamphetamine, billed as a single unit with CPT () Definitive LC-MS/MS test billed as a single unit with CPT 803 for 1 to 3 antipsychotics and with CPT 8033 for to 6 antipsychotics; or for HCPCS payers, as aripiprazole (85), clozapine (809), haloperidol (80173), olanzapine (85), quetiapine (85) and risperidone (85), each billed separately. () Depending on the specific tests ordered, immunoassay tests are billed as a single unit with CPT for drugs on the CPT Drug List A and with CPT for each procedure performed for drugs on Drug List B. See for a listing of the drugs in the CPT Drug Lists. For HCPCS payers, immunoassay tests are billed as a single unit with HCPCS G031. (16) This option offers definitive LC-MS/MS testing of qualitative presumptive screens with lower cut-off levels and specific drug identification. Except where noted, each separate drug tested is billed separately with the relevant CPT or HCPCS code. This testing should be ordered ONLY if the health care provider deems it necessary to have information that initial screening with qualitative immunoassays alone will not provide (e.g., where the health care provider deems it necessary to test at levels below the cutoff for the immunoassay screen, when specific drug identification and quantification may be necessary, or when cross-reactivity to other medications are concerns). (17) If creatinine is excluded from Specimen Validity Testing, historical graphed results will not be produced in reporting. (18) Offered as an immunoassay test and billed with CPT 8703 for both CPT and for HCPCS payers. Analysis for hcg must be conducted within three days of collection. Specimens received after three days will not be analyzed for hcg 8 copy or distribute without express written permission from Millennium Health, LLC. MLI-ADF001 Millennium Health, LLC /0