CLC Drugs of Abuse Booklet 9-11-12

Wake Forest Biotech Place575 N. Patterson Avenue, Suite 430Winston-Salem, NC 27101 • 877-722-8910 or 336-722-8910 • fax 336-722-8915

carolinachemistries.com

Drugs of Abuse

2012

Table of ContentsExecutive Summary..........................................................................................................1

CLC720 Brochure.........................................................................................................3-6

CLC480 Brochure......................................................................................................7-10

BioLis24i Brochure..................................................................................................11-14

Toxicology Clinic Example..........................................................................................15

CLC720 Calibration Curve..........................................................................................17

Test Menu.......................................................................................................................18

Patient Sample Report...................................................................................................19

MLN Matters............................................................................................................21-24

Profitability of G0431....................................................................................................25

Profitability of Semi-Quantitative Screen...................................................................27

High Complexity Letter................................................................................................29

High Complexity Laboratories....................................................................................30

ICD-9 Codes: Quick Reference ............................................................................31-32

Quantitative Coding.....................................................................................................33

Drugs of Abuse Coding Quick Reference..................................................................35

Millennium Letter: Billing/Coding Alert...................................................................37Centers for Medicare & Medicaid Services –Laboratory Requirements..........39-40

Estimated Reimbursement by Insurance Provider....................................................41

Health Insurance Claim Form.....................................................................................43

Drugs of Abuse Ordering Sheet...................................................................................45

Notes...............................................................................................................................47

Executive Summary

Faster turnaround time for laboratory results means quicker time to diagnose and treat. Prompt diagnosis and treatment saves lives – it’s that simple!

Pain management clinics that monitor patients use and potential misuse of prescription drugs can now perform drug testing within their own facility. This can improve patient care and increase revenue to sustain and grow the practice. An on-site laboratory addresses pharmatherapeutic and pharmacokinetic issues, substance abuse, misuse, diversion, addiction, and medical legal issues on the spot.

Carolina Liquid Chemistries Corp. (CLC) is a manufacturer, distributor and re-furbisher of chemistry systems and reagents. Carolina Liquid Chemistries offers the CLC720 and CLC480 / BioLis24i as a solution for clinics in need of a vehicle to perform drug testing in their own facilities. Each of these analyzers can run up to 25 drugs of abuse and over 90 different chemistry tests including renal and liver profiles. Practices can now set up laboratories within their own facility and obtain same day results rather than waiting on test results from an outside laboratory. Physicians can now make treatment decisions such as medication adjustments for their patients before they even leave their office. We offer some of the most extensive menus on the market and give practices the ability to set their own therapeutic test cutoffs in ng/mL. For larger laboratories, CLC also recycles and refurbishes Olympus AU instruments.

Operational ExpensesSetting up an on-site laboratory will require technical expertise, an investment in staff, equipment and compliance. CLC has been assisting laboratories in getting started for over 15 years. Should a laboratory need assistance in these areas CLC offers consulting services including: laboratory compliance and laboratory directorship. Our consultants have excellent credentials and are well respected in their fields. Our consultants are independent and “pass through” contractors. This means that CLC does not profit from their fees. CLC connects you with these consultants to save you time, thus eliminating your need to do the research. If planning on starting a laboratory, a sound estimated budget for fixed operational costs would be $52,000. This includes your Technical Director, High Complexity Laboratory Director and registered Technologist. Estimated ranges for variable costs are $17.09 per reportable test for a lab testing 10 patients per day to as low as $9.86 per reportable result for a lab testing 50 patients per day.

FinancialAll laboratories should check with their insurance carriers to confirm reimbursement for tests. Estimated profit projections are dependent on insurance mix and reimbursement by local carriers and Medicare. MLN Matters article addresses the 2011 Medicare reimbursement environment for DAUs. Please see link for further information: http://www.cms.gov/MLNMatterArticles/Downloads/SE1105.pdf

It is estimated that the financial feasibility for a laboratory running DAU testing can range from $216,000 per year for a laboratory running 10 specimens to $1,100,000 per year for a laboratory running 50 specimens.

After reviewing the cost/benefit and financial analysis, it is clear that in-house testing will improve care and practice sustainability.

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• Discrete, random access, fully automated

• Up to 560 tests per hour with ISE

• Up to 77 onboard chemistries plus Na+, K+, Cl-

• Refrigerated reagent compartment

• Sample tray: 90 positions

• Automatic probe cleaning, liquid level detection, clot detection, probe collision protection

• 8-step auto washing system

• 12 wavelengths: 340~800nm

• Automatic dilution of high samples above usable range

• Internal reagent and sample barcode reader

• Bi-directional LIS interface with host query

• Eliminates the need for cumbersome racks

• Pre-dilution for certain assays

• STAT capabilities

CLC720Chemistry AnalyzerCLC720Chemistry Analyzer

4

Real-time monitoring of working status.

Clot detection to avoid incorrect reaction at the very beginning of the reaction process.

High performance, reusable cuvettes, and accurate results.

carol inachemistr ies.comcarol inachemistr ies.com

CRP wide-rangeCystatin CD-dimerDigoxinDirect BilirubinEnzymaticFibrinogenFructosamineGentamicinGGTGlucoseGlucose, urineGlycoMark™

HaptoglobinHBDHDL-directHbA1cHomocysteinehsCRPIgAIgGIgMInsulinIronLactateLP(a)LDHLDL-directLidocaineLipaseLithiumMagnesiumMethadoneMethaqualoneMicroalbuminNAPA

OpiateOxycodonePancreatic AmyPhenobarbitalPhenytoinPhosphorusPhosphorus, urinePlac® TestPotassiumPotassium urinePrealbuminPrimidoneProcainamidePropoxypheneQuinidineRFSalicylateSodiumSodium,urineTheophyllineThyroxine (T4)TIBCTIBC DirectTobramycinTotal Bile AcidsTotal BilirubinTotal Protein, urineTransferrinTricyclicTriglyceridesT-UptakeUIBCUric AcidUric Acid, urineValproic AcidVancomycinPlac® Test is a registered trademark of diaDexus.

CLC720 Chemistry Analyzer Test MenuAcetaminophenAcid PhosAlbuminAlcoholAlk PhosALTAmikacinAmmoniaAmphetamineAmylaseAPO A1APO BASOASTBarbiturateBenzodiazepineBUNBUN, urineC3C4CalciumCalcium, urineCannabinoidCarbamazepineChlorideChloride, urineCholesterolCholinesteraseCKCK-MBCO2CocaineCotinineCreat, urineCreatinineCRP

DRUGS OF ABUSE6-AMAcetaminophenAlcohol (ETOH) Amphetamine (AMPH)Barbiturate (BARB)Benzodiazepine (BENZ)Buprenorphine (BUP)Cannabinoids (THC) Carisoprodol (CARI)*

Cocaine (COCM)Creatinine (UCREA) Ecstasy (XTSY) Ethylglucuronide (EtG)Fentanyl (FENT)*

Meperidine (MEP)*

Methadone (METD)Methadone Metabolites (EDDP)Opiate (OP)Oxycodone (OXYC)

Phencyclidine (PCP)Propoxyphene (PROX)Salicylate (SAL)Tapentadol) (TAP)*

Tricyclics (TCA)Tramadol (TRAM)*

Zolpidem (ZOL)*

ADULTERANTSAdulterantsAldehydeBUNChromate ReagentHalogenNitriteOxidantpH reagentSpecific Gravityand more...* for forensic use

5


• Up to 560 tests per hour with ISE

• Up to 77 onboard chemistries plus Na+, K+, Cl-

• Refrigerated reagent compartment

• Sample tray: 90 positions

• Automatic probe cleaning, liquid level detection, clot detection, probe collision protection

• 8-step auto washing system

• 12 wavelengths: 340~800nm

• Automatic dilution of high samples above usable range

• Internal reagent and sample barcode reader

• Bi-directional LIS interface with host query

• Eliminates the need for cumbersome racks

• Pre-dilution for certain assays



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carol inachemistr ies .com

CLC480Chemistry Analyzer

Routine chemistry. Special chemistry. Drugs of abuse.


CC480.rv2dgtl.0812

510K Pending


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• 400 tests per hour

• 100 chemistry tests available

• No disposable cuvettes required

• Barcoded sample tubes and reagents

• Barcoded ready-to-use reagents

• Bidirectional interface with host query

• Electrolytes by ion selection electrodes

• 30-day onboard reagent stability

• 14-day calibration stability (most analytes)

• 24-hour reagent cooling

• Less operational noise


• Wavelength 340-800 nm

• Automatically tracks reagent stability and position

• Controls assayed for Carolina Chemistries reagents with peer group survey


The versatility of use in varying laboratory environments puts the CLC480 above all others in its class.

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carol inachemistr ies.com

CLC480 Chemistry Analyzer Test MenuAcetaminophenAcid PhosAlbuminAlcoholAlk PhosALTAmikacinAmmoniaAmphetamineAmylaseAPO A1APO BASOASTBarbiturateBenzodiazepineBUNBUN, urineC3C4CalciumCalcium, urineCannabinoidCarbamazepineChlorideChloride, urineCholesterolCholinesteraseCKCK-MBCO2CocaineCotinineCreat, urineCreatinineCRP






Meperidine (MEP)*


The CLC480 has the most extensive menu of the benchtop chemistry analyzer market.



Zolpidem (ZOL)*

ADULTERANTSAldehydeBUNChromate ReagentHalogenNitriteOxidantpH reagentSpecific Gravityand more...* for forensic use

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System function: Fully automated, discrete, random access chemistry analyzer with water system.

Analysis: Number of test items onboard: 36+3 (ISE)

Throughput: 240 photometric plus 160 ISE, 400 tests/hour

Analysis method: Endpoint, rate, ISE, Turbidimetry

Stat interruption

Calculated results

Auto dilution and rerun of out-of-range results

Sample pre-dilution (1/10)

Antigen excess detection

Sample handling: Sample type: Serum, plasma, urine, CSF

Sample container: Sample cup, primary tube (5, 7, 10 ml)

Number of samples onboard: 55 position sample tray

3 to 30µL sample size

Sample volume level detection

STAT capabilities: STAT sample priority

Reagents: Number onboard: 36 tests onboard

Liquid ready-to-use

Barcoded

Tracks test remaining

30-day onboard stability

Calibration: Chemistry – 14-day stability

ISE – 24-hour stability

Single point, multi-point

Linear, spline, logit-log

Reaction System: Optical source: Bi-chromatic

Automatic, discrete, random access

Automatic cell blank correction

Optical source: Tungsten halogen lamp

Optical measurement: Wavelengths – 340, 380, 405, 505, 546, 570, 600, 700, 750 and 800 nm

Cuvette material: 60 self-cleaning semi-permanent cuvettes

Reaction: Displays graphic reaction curve

Cuvette washing: Alkaline, acid, automatic 10-step, high temp, cuvette washing

Reagent mixing: Dual chamber cuvette reagent mixing

User interface: Software: Windows® XP based

Bidirectional LIS interface – RS-232

Automatically programs patient ID and tests

Barcodes – Code 39, Code 128, ITF, NW-7

Levy Jennings QC monitoring

Water, wash and waste alarms

Water/drain – self contained

Preventative maintenance screen

Power supply: AC 100/115/230 volt (50/60 Hz)

Dimension: 31.5” x 26.5” x 20.5” (W x D x H)

Weight: Approx. 210 lbs.

Warranty: One year

Support: 877-722-8910

Wake Forest Biotech Place , 575 N. Patterson Avenue, Suite 430, Winston Salem, NC 27101 • 877-722-8910 or 336-722-8910 • fax 336-722-8915


Technical Specifications



CC480.rv2dgtl.0812

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Routine chemistry. Special chemistry. Drugs of abuse.

BioLis24iChemistry Analyzer


510K Pending


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• 400 tests per hour

• 100 chemistry tests available

• No disposable cuvettes required

• Barcoded sample tubes and reagents

• Barcoded ready-to-use reagents

• Bidirectional interface with host query

• Electrolytes by ion selection electrodes

• 30-day onboard reagent stability

• 14-day calibration stability (most analytes)

• 24-hour reagent cooling

• Less operational noise


• Wavelength 340-800 nm

• Automatically tracks reagent stability and position

• Controls assayed for Carolina Chemistries reagents with peer group survey

• Remote diagnostics

BioLis24iChemistry AnalyzerBioLis24iChemistry Analyzer

The versatility of use in varying laboratory environments puts the BioLis24i above all others in its class.

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carol inachemistr ies.com

The BioLis24i has the most extensive menu of the benchtop chemistry analyzer market.




BioLis24i Chemistry Analyzer Test MenuAcetaminophenAcid PhosAlbuminAlcoholAlk PhosALTAmikacinAmmoniaAmphetamineAmylaseAPO A1APO BASOASTBarbiturateBenzodiazepineBUNBUN, urineC3C4CalciumCalcium, urineCannabinoidCarbamazepineChlorideChloride, urineCholesterolCholinesteraseCKCK-MBCO2CocaineCotinineCreat, urineCreatinineCRP



Meperidine (MEP)*




Zolpidem (ZOL)*

ADULTERANTSAdulterantsAldehydeBUNChromate ReagentHalogenNitriteOxidantpH reagentSpecific Gravityand more...* for forensic use

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-

System function: Fully automated, discrete, random access chemistry analyzer with water system.

Analysis: Number of test items onboard: 36+3 (ISE)

Throughput: 240 photometric plus 160 ISE, 400 tests/hour

Analysis method: Endpoint, rate, ISE, Turbidimetry

Stat interruption

Calculated results

Auto dilution and rerun of out-of-range results

Sample pre-dilution (1/10)

Antigen excess detection

Sample handling: Sample type: Serum, plasma, urine, CSF

Sample container: Sample cup, primary tube (5, 7, 10 ml)

Number of samples onboard: 55 position sample tray

3 to 30µL sample size

Sample volume level detection

STAT capabilities: STAT sample priority

Reagents: Number onboard: 36 tests onboard

Liquid ready-to-use

Barcoded

Tracks test remaining

30-day onboard stability

Calibration: Chemistry – 14-day stability

ISE – 24-hour stability

Single point, multi-point

Linear, spline, logit-log

Reaction System: Optical source: Bi-chromatic

Automatic, discrete, random access

Automatic cell blank correction

Optical source: Tungsten halogen lamp

Optical measurement: Wavelengths – 340, 380, 405, 505, 546, 570, 600, 700, 750 and 800 nm

Cuvette material: 60 self-cleaning semi-permanent cuvettes

Reaction: Displays graphic reaction curve

Cuvette washing: Alkaline, acid, automatic 10-step, high temp, cuvette washing

Reagent mixing: Dual chamber cuvette reagent mixing

User interface: Software: Windows® XP based

Bidirectional LIS interface – RS-232

Automatically programs patient ID and tests

Barcodes – Code 39, Code 128, ITF, NW-7

Levy Jennings QC monitoring

Water, wash and waste alarms

Water/drain – self contained

Preventative maintenance screen

Power supply: AC 100/115/230 volt (50/60 Hz)

Dimension: 31.5” x 26.5” x 20.5” (W x D x H)

Weight: Approx. 210 lbs.

Warranty: One year

Support: 877-722-8910 Remote diagnostics available

Wake Forest Biotech Place , 575 N. Patterson Avenue, Suite 430, Winston-Salem, NC 27101 • 877-722-8910 or 336-722-8910 • fax 336-722-8915





BioLis24i.rv1dgtl.0812

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CLC720 CALIBRATION CURVETest: AMPH2 Rule: Spline Date/Time: 8/9/2012 2:05:57 PM

Absorbance

4900

4600

4300

4000

3700

3400

3100

2800

2500

2200

1900

Calibration Curve

0 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000

CALIBRATION DATACalibrators Concentration Absorbance

Blank 0 2440MDAU Low 500 3292MDAU Cutoff 1000 3903MDAU Med 1500 4265MDAU High 2000 4556

Concentration

INSTRUMENTED IMMUNOASSAY

IMPROVES SENSITIVITY

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CLC480 / CLC720 MENU

6-AMACETAMPHBARBBENZBUPCARI*

COCMEDDPETG

ETOH FENT*

MEP*

METDOPOXYCPCPPROXSALTAP*

TCATHCTRAM*

XTSYZOL*

AdulterantsAldehydeBUNCromate Reagent

HalogenNitriteOxidantpH reagentUCREASpecific Gravityand more...

Drugs of Abuse

* for forensic use

Reagents

ALBALPALTAST AmylaseAPO A1APO B Bile AcidBUNCA

CHOL CK CO2CREACRPDBILFRUCGGTGlycomarkGLU

HbA1cHDLDHYCInsulinIronLDHLDLD LipaseLithiumLp(a)MAIB

MGPO4RFTBILTIBCTPTransferrinTGUric AcidPlac® Test

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CAROLINA LIQUID CHEMISTRIES 575 N. PATTERSON AVE. SUITE 430

WINSTON-SALEM, NC 27106 TEL. 336-722-8910

Name: Carolina Liquid Chemistries SSN: 111-11-1111 Patient ID No.: CC 010101 Comment 1: Hemolysis: Lipemia: Fasting: Date of Birth: 01-01-1956 Age: 55 years Sex: Female Comment 2: Doctor: Draw Date: 01-01-2012 04:37PM Test Name Result Units Flag Reference Range AMPH 62 ng/mL 0 – 1000 BARB 12 ng/mL 0 – 200 BENZ 50 ng/mL 0 – 200 COCM 0 ng/mL 0 – 300 ETHA 0 ng/mL 0 – 100

METD 119

ng/mL 0 – 300 OP300 1421H ng/mL 0 – 300 PCP 2 ng/mL 0 – 25 PROX 1 ng/mL 0 – 300 THC50 0 ng/mL 0 – 50 OXYC 202 ng/mL 0 – 300 XTSY 0 ng/mL 0 – 500 UCRE 51 ng/mL 40 – 260 CUP 0 ng/mL 0 – 10 6 AM 0 ng/mL 0 – 10

-- End of Report –

Reviewed by:_____________________ Date:_______________ Page 1 SSN: 111-11-1111 Patient ID No: CC 010101 Printed 08-10-2012 Lab Results for: Carolina Liquid Chemistries

Provider’s Assessment of Immunoassay Results Results were reviewed during follow up visit

Immunoassay Results PARAMEDICAL Confirmation __ Consistent with compliance: no drugs of abuse __ Amphetamine __ Fentanyl __ Opiods (Class) __ No drugs of abuse detected __ Barbiturates (ELISA) __ Ketamine __ Consistent with potential aberrant behaviors V71.09 __ Oxycodone __ Benzodiazepines (Class) __ No medication reaches threshold of positive today __ MDA __ Phencyclidine (PCP) __ Buprenorphine __ Corrective action required. Consider: __ MDEA __ Propoxyphene __ Carisoprodol __ Restriction of interval between visits __ Meparidine __ THC (ELISA) __ Cocaine __ Cognitive Behavioral Counseling __ Methemphetamine __ Tramadol __ Physician Counseling or Referral __ Ectasy (MDMA) __ Methadone __ Other: _________ Medical Necessity Statement: Within the realm of reasonable medical certainty the physician has determined that frequent and periodic high complexity immunoassays (Qualitative and/or Quantitative) using the Carolina BioLis 24i are medically necessary to affirm compliance to the use of prescribed dangerous medications on a long term basis (V58.69) and/or to affirm the absence of other dangerous substances and ETOH that might cause adverse interactions or outcomes, or aggravate other mental conditions (V71.09). These tests are also medically necessary to detect and prevent abuse, accidental death by overdose, addiction, diversion of dangerous drugs, or aggravation of various mental conditions. __________________________ ____________________________ _____________________________ Carolina Liquid Chemistries, M.D. Carolina Liquid Chemistries NP-DC Carolina Liquid Chemistries, Lab Consultant

CLIA # 11A1111111 19

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News Flash – Looking for the latest Medicare Fee-For-Service (FFS) information? Then subscribe to a Medicare FFS Provider listserv that suits your needs! For information on how to register and start receiving the latest news, go to http://www.cms.gov/MLNProducts/downloads/MailingLists_FactSheet.pdf on the Centers for Medicare & Medicaid Services (CMS) website.

MLN Matters® Number: SE1105 Related Change Request (CR) #: N/A

Related CR Release Date: N/A Effective Date: N/A

Related CR Transmittal #: N/A Implementation Date: N/A

Medicare Drug Screen Testing

Provider Types Affected

This article is for clinical laboratories billing Medicare Carriers, Fiscal Intermediaries (FIs), or Part A/B Medicare Administrative Contractors (A/B MACs).

Provider Action Needed

This article describes how clinical diagnostic laboratories should bill for certain types of tests that are covered under Medicare and paid based on the Clinical Laboratory Fee Schedule (CLFS). Specifically, the article addresses the billing of two CLFS Healthcare Common Procedure Coding System (HCPCS) test codes - G0431 (Drug screen, qualitative; multiple drug classes by high complexity test method (e.g., immunoassay, enzyme assay), per patient encounter) and G0434 (Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter) - beginning January 1, 2011. HCPCS code G0434 is new for Calendar Year (CY) 2011. Please be certain that your billing staffs are aware of these changes.

Background

Each year, the Centers for Medicare and Medicaid Services (CMS) hosts an Annual Public Meeting to discuss test codes that have been established by the

Disclaimer This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents. CPT only copyright 2010 American Medical Association.

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MLN Matters® Number: SE1105 Related Change Request Number: N/A


Page 2 of 4

Common Procedural Terminology (CPT) committee, and may be covered by Medicare, and paid based on the CLFS in the upcoming calendar year.

During the 2009 Annual Public Meeting, CMS introduced two new CY 2010 HCPCS codes for reporting qualitative drug screen testing - G0430 (Drug screen, qualitative; multiple drug classes other than chromatographic method, each procedure), which was reported once per procedure and G0431, which is reported once per drug class. (Please note that G0430 was deleted beginning January 1, 2011). After the introduction of these codes, CMS determined that it needed to further refine these drug screen testing codes and revise the descriptors to avoid unnecessary or excessive utilization of code G0431 for relatively simple point-of-care tests that screen for multiple substances. During the 2010 Annual Public Meeting, CMS introduced code G0434 to report qualitative point-of-care drug screen testing and to limit billing for such testing to one time per patient encounter. CMS also revised the descriptor for code G0431 to emphasize that the code describes all screening for multiple drug classes per patient encounter.

CMS recognizes that there could be rare instances where a patient requires multiple, medically necessary screening tests for drugs of abuse to be performed in a single day. For instance, a patient seen in an outpatient pain clinic who requires a drug screening test as a part of his/her care is later admitted to an emergency department after an automobile accident and requires another medically necessary drug screening test. The use of “per patient encounter” will allow payment to be made for this rare circumstance.

Effective January 1, 2011, CMS will utilize two test codes to report drug screen testing:

• G0434 (Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter) will be used to report very simple testing methods, such as dipsticks, cups, cassettes, and cards, that are interpreted visually, with the assistance of a scanner, or are read utilizing a moderately complex reader device outside the instrumented laboratory setting (i.e., non-instrumented devices). This code is also used to report any other type of drug screen testing using test(s) that are classified as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity test(s), keeping the following points in mind:

o G0434 includes qualitative drug screen tests that are waived under CLIA as well as dipsticks, cups, cards, cassettes, etc, that are not CLIA waived.

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Page 3 of 4

o Laboratories with a CLIA certificate of waiver may perform only those tests cleared by the Food and Drug Administration (FDA) as waived tests. Laboratories with a CLIA certificate of waiver shall bill using the QW modifier.

o Laboratories with a CLIA certificate of compliance or accreditation may perform non-waived tests. Laboratories with a CLIA certificate of compliance or accreditation do not append the QW modifier to claim lines.

o Only one unit of service for code G0434 can be billed per patient encounter regardless of the number of drug classes tested and irrespective of the use or presence of the QW modifier on claim lines.

• G0431 (Drug screen, qualitative; multiple drug classes by high complexity test method (e.g., immunoassay, enzyme assay), per patient encounter) will be used to report more complex testing methods, such as multi-channel chemistry analyzers, where a more complex instrumented device is required to perform some or all of the screening tests for the patient. Note that the descriptor has been revised for CY 2011. This code may only be reported if the drug screen test(s) is classified as CLIA high complexity test(s) with the following restrictions:

o G0431 may only be reported when tests are performed using instrumented systems (i.e., durable systems capable of withstanding repeated use).

o CLIA waived tests and comparable non-waived tests may not be reported under test code G0431; they must be reported under test code G0434.

o CLIA moderate complexity tests should be reported under test code G0434 with one (1) Unit of Service (UOS).

o G0431 may only be reported once per patient encounter.o Laboratories billing G0431 must not append the QW modifier to claim

lines.

CMS has also made changes to the following related tests:

• G0430 was deleted as of January 1, 2011; • Code 80100 has not been priced under Medicare effective January 1, 2011;

and• Code 80104 has not been priced under Medicare effective January 1, 2011.

Also, please remember that code 80101 has not been priced under Medicare since July 1, 2010.

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Page 4 of 4

Additional Information

CMS publishes a list of test products with CLIA waived status each quarter. Providers may use this list to determine if a particular test product can be appropriately performed by a laboratory with a CLIA waiver and is eligible to be billed using the QW modifier. Concerning CLIA moderate or high complexity tests, providers should confirm a test’s status with the test manufacturer.

If you have any questions, please contact your carrier, FI, or A/B MAC at their toll-free number, which may be found at http://www.cms.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS website.

Additional information concerning the CLFS can be found at http://www.cms.hhs.gov/ClinicalLabFeeSched on the CMS website.

News Flash - It’s Not too Late to Give and Get the Flu Vaccine. Take advantage of each office visit and continue to protect your patients against the seasonal flu. Medicare will continue to pay for the seasonal flu vaccine and its administration for all Medicare beneficiaries through the entire flu season. The Centers for Disease Control and Prevention (CDC) recommends that patients, health care workers and caregivers be vaccinated against the seasonal flu. Protect your patients. Protect your family. Protect yourself. Get Your Flu Vaccine - Not the Flu.


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Additional Expenses for a High Complexity Lab • $24,000/Year for a consulting High Complexity Director • $5,000/Year for a Technical Director • $24,000/Year for a Registered Technologist • $52,000/Year Total Additional Expense • Running a Full 19 Test Profile The above are not included in the following analysis

Profitability G0431* Carolina Liquid Chemistries Analyzers

DAU Volume

# of Profiles / Day Estimated Profit Profit / Year **

10 $ 110,900

20 $ 278,000

30 $ 445,000

40 $ 613,000

50 $ 780,000 * General analysis more complete analysis on Specific Physician Customized Analysis TC/R G0431/82055/82570 – 5 Test Screen with ETOH and Urine Creatinine – includes instrument, reagents and calibrators ** Based on $100/profile reimbursement/Medicare profile

Additional Profiles Reimbursement CPT Code Liver Profile 11.29 80076

Renal 12.00 80069 Revenue projections are benchmarked using Medicare payout. Profit picture may change depending on your insurance mix. Profit is subject to change depending on local providers. Check with your providers for payouts in your area. Reimbursement is dependent upon ordering with proper ICD-9 Diagnosis Codes. Note: This is a general analysis. A more complete analysis can be provided that is specific to your practice.

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Additional Expenses for a High Complexity Lab • $24,000/Year for a consulting High Complexity Director • $5,000/Year for a Technical Director • $24,000/Year for a Registered Technologist • $52,000/Year Total Additional Expense • Running a Full 19 Test Profile The above are not included in the following analysis

Profitability Semi-Quantitative Screen* Carolina Liquid Chemistries Analyzers

DAU Volume

# of Profiles / Day Estimated Profit Profit / Year **

TC/R Profile***

10 $ 1,079,210 $ 68.26

20 $ 2,245,281 $ 51.56

30 $ 3,411,352 $ 45.99

40 $ 4,577,423.99 $ 43.20

50 $ 5,743,495.10 $ 41.53 * General analysis more complete analysis on Specific Physician Customized Analysis ** Based on $476.27/profile reimbursement/Medicare profile *** TC/R Semi-Quantitative/82055/82570 – 22 Test Semi-Quantitative Screen with ETOH and Urine Creatinine – includes instrument, reagents and calibrators

Additional Profiles Reimbursement CPT Code Liver Profile 11.29 80076

Renal 12.00 80069 Revenue projections are benchmarked using Medicare payout. Profit picture may change depending on your insurance mix. Profit is subject to change depending on local providers. Check with your providers for payouts in your area. Reimbursement is dependent upon ordering with proper ICD-9 Diagnosis Codes. Note: This is a general analysis. A more complete analysis can be provided that is specific to your practice.

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High Complexity Laboratories

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Quick Reference ICD-9 Codes Associated with Drugs of Abuse Panels and Drug Screen Panels

291.1 Alcohol amnestic syndrome 291.2 Alcohol dementia, other 291.3 Alcohol withdrawal with hallucinosis 291.4 Idiosyncratic alcohol intoxication 291.5 Alcoholic jealousy 291.8 Other specified alcoholic psychosis 291.9 Unspecified alcoholic psychosis 292.1 Paranoid and/or hallucinatory states induced by drugs 292.11 Drug-induced organic delusional syndrome 292.8 Other specified drug-induced mental disorders 292.82 Drug-induced dementia 292.83 Drug-induced amnestic syndrome 292.84 Drug-induced organic effective syndrome 292.9 Unspecified drug-induced mental disorder 295.0 Schizophrenic disorders. Simple type 295.1 Schizophrenic disorders. Disorganized type 295.6 Schizophrenic disorders. Residual schizophrenia 295.7 Schizophrenic disorders. Schizo-affective type 296.0 Affective psychoses. Manic disorder, single episode 296.9 Affective psychoses. Other and unspecified affective psychoses 296.99 Affective psychoses. Other specified affective psychoses 297.0 Paranoid state, simple 297.1 Paranoia 297.9 Unspecified paranoid state 298.0 Depressive type psychosis 298.1 Excitative type psychosis 298.2 Reactive confusion 298.3 Acute paranoid reaction 298.4 Psychogenic paranoid psychosis 298.8 Other and unspecified reactive psychosis 298.9 Unspecified psychosis 300.0 Neurotic disorders. Anxiety states 300.00 Anxiety state, unspecified 300.01 Panic disorder 300.02 Generalized anxiety disorder 300.09 Anxiety sate. Other. 300.11 Hysteria. Conversion disorder 300.13 Hysteria. Psychogenic fugue 300.15 Hysteria. Psychogenic Dissociative disorder or reaction, unspecified 300.19 Hysteria. Other and unspecified factitious illness 300.4 Neurotic depression 300.5 Neurasthenia 300.9 Unspecified neurotic disorder 301.0 Paranoid personality disorder 301.3 Explosive personality disorder 304.0 Drug dependence. Opioid type dependence 304.1 Drug dependence. Barbiturate and similarity acting sedative or hypnotic dependence

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304.2 Cocaine dependence 304.3 Cannabis dependence 304.4 Amphetamine and other psychostimulant dependence 304.7 Combinations of opioid type drug with any other 304.8 Combinations of drug dependence excluding opioid type drug 304.9 Unspecified drug dependence 305.2 Cannabis abuse 305.4 Barbiturate and similarly acting sedative or hypotonic abuse 305.5 Opioid abuse 305.6 Cocaine abuse 305.7 Amphetamine or related acting sympathomimetic abuse 305.8 Antidepressant type abuse 305.9 Other, mixed or unspecified drug abuse 345.1 Epilepsy. Generalized convulsive 345.3 Epilepsy. Grand mal status 345.9 Epilepsy, unspecified 780.0 General symptoms. Alteration of consciousness 780.01 Coma 780.02 Transient alteration of awareness 780.1 Hallucinations 780.2 Syncope and collapse 780.3 Convulsions 780.39 Other convulsions 785.0 Symptoms involving cardiovascular system. Tachycardia, unspecified 785.1 Palpitations 786.50 Chest pain, unspecified 796.0 Nonspecific abnormal toxicological findings Disclaimer: The information provided on this website is current as of February 2005 and was obtained from third-party sources and is subject to change without notice as a result of changes in reimbursement laws, regulations, rules, policies, and payment amounts. All content on this website is informational only, general in nature, and does not cover all situations or all payers’ rules and policies. This content is not intended to instruct hospitals and/or physicians on how to use or bill for healthcare procedures, including new technologies outside of Medicare national guidelines. A determination of medical necessity is a prerequisite that Carolina Chemistries assumes will have been made prior to assigning codes or requesting payments. Hospitals and physicians should consult with appropriate payers, including Medicare fiscal intermediaries and carriers, for specific information on proper coding, billing, and payment levels for healthcare procedures.

ICD-9 Codes Continued

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Quantitative Coding Code for Initial Urine Cup Drug Screen – G0434 Drug screen, other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter Reimbursement - $20.00/Cup* Code for Quantitative Drug Screen Assay Estimated Allowable Code Cannabinoid $ 19.40 Cpt Code – 80299-59

Opiate $ 27.56 Cpt Code – 83925

Cocaine $ 21.33 Cpt Code – 82520

Ampthetamine $ 21.87 Cpt Code – 82145

Propoxyphene $ 27.56 Cpt Code – 83925

Phencyclidine PCP $ 19.27 Cpt Code – 80299-59

Barbituate $ 16.12 Cpt Code – 82205

Benzodiazapine $ 26.03 Cpt Code – 80154

Oxicodone $ 27.38 Cpt Code – 83925-59

Ecstacy $ 19.27 Cpt Code – 80299-59

6-Acetylmorphine (6-AM) $ 27.56 Cpt Code – 83925-59

Buprenorphine $ 27.56 Cpt Code – 83925-59

Alcohol $ 15.30 Cpt Code – 82055

Methadone $ 23.13 Cpt Code – 83840

Carisoprodol $ 19.40 Cpt Code – 80299-59

Methadone Metabolite $ 23.13 Cpt Code – 83840-59

Ethylglucuronide $ 19.40 Cpt Code – 80299-59

Fentanyl $ 19.40 Cpt Code – 80299-59

Meperidine $ 19.40 Cpt Code – 80299-59

Tapentadol $ 19.40 Cpt Code – 80299-59

Zolpidem $ 19.40 Cpt Code – 80299-59

Tramadol $ 19.40 Cpt Code – 80299-59

Creatinine $ 7.07 Cpt Code – 82570

Reimbursement - $476.27/Profile *Revenue projections are estimated and benchmarked using Medicare payout. Profit picture may change depending on your insurance mix. Profit is subject to change depending on local providers. Check with your providers for payouts in your area. Reimbursement is dependent upon ordering with proper ICD-9 Diagnosis Codes.

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Quick Reference List – Drugs of Abuse Coding The methodology for the BioLis 24i is Enzyme Immunoassay. Today, the BioLis 24i is considered a highly complex analyzer. The Drugs of Abuse (DAU) assays used on the BioLis 24i are both qualitative and semi-quantitative yielding an actual number. In 2011, the new code for the qualitative screen is G0431. This does not include the Creatinine and Alcohol tests which have separate codes.

Quantitative Qualitative

Opiates 83925 Opiates G0431 Cocaine 82520 Cocaine G0431-59 Amphetamines 82145 Amphetamines G0431-59 Barbiturates 82205 Barbiturates G0431-59 Benzodiazepines 80154 Benzodiazepines G0431-59 Methadone 83840 Methadone G0431-59 PCP 83992 PCP G0431-59 THC 80299-91 THC G0431-59 Propoxyphene 83925 Propoxyphene G0431-59 Oxycodone 80299-91 Oxycodone G0431-59 Ecstasy 80299-91 Ecstasy G0431-59 Buprenorphine 83925 Buprenorphine G0431-59 Urine Creatinine 82570 Urine Creatinine 82570 Alcohol 82055 Alcohol 82055

Note: It is the responsibility of each laboratory to check with their local carriers to confirm the accuracy of the codes used.

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Trailblazer, the Medicare contractor for Texas, Oklahoma, New Mexico and Colorado just issued a coding bulletin similar to the Palmetto one regarding the proper billing for tests performed on Immunoassay Instruments in physician office labs. They deem the use of high complexity qualitative codes (G0431) or quantitative codes as systematic upcoding. We can discuss on Monday the best method for distributing this information to our clients. Finally!!

Billing/Coding Alert: Semi-Quantitative Drug Testing Date: (3/22/2012) Notice ID: 14875 Potential Primary Billers at Risk: Pain Management Physicians and other providers may be at risk for audits or overpayment requests if they bill drug monitoring services to monitor drugs of abuse and submit a claim using a code for a quantitative test rather than a qualitative test. In order to effectively treat chronic pain, physicians often use drug testing to monitory prescribed medications and drugs of abuse (see the “Qualitative Drug Screening” Local Coverage Determination (LCD)). Practices may purchase or lease Enzyme Immunoassay (EIA) devices to provide preliminary qualitative or semi-quantitative test results for monitoring purposes. EIA devices and the reagents used to perform in-office drug testing are Food and Drug Administration (FDA)-cleared only to obtain qualitative or semi-quantitative initial screen/preliminary results. Since an immunoassay and an enzyme assay are by definition moderate complexity tests that produce qualitative and semi-quantitative results, they may not be reported with a quantitative code. Confirmation or quantification of the preliminary result is not usually produced in a point-of-care setting. The initial drug screen/preliminary result should be reported with code G0434 – Drug screen other than chromatographic; any number of drug classes, by CLIA waived test or moderate complexity test, per patient encounter. The following codes should not be reported for the initial screen/preliminary result when performed by EIA:

• G0431 – Drug screen, qualitative; multiple drug classes by high complexity test method. • CPT “Chemistry” section, codes 82000-84999. • CPT “Drug Testing” section, codes 80100-80104. • CPT “Therapeutic Drug Assays” section, codes 80150-80299.

Use of the above codes to report preliminary qualitative or semi-quantitative test results is considered systematic upcoding and may lead to criminal and civil penalties. If you believe your practice has made this error, it may be in your best interest to take the following corrective actions:

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Code of Federal Regulations] [Title 42, Volume 5] [Revised as of October 1, 2010] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR493.17] [Page 516-517] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF PART 493_LABORATORY REQUIREMENTS Subpart A_General Provisions Sec. 493.17 Test categorization. (a) Categorization by criteria. Notices will be published in the Federal Register which list each specific test system, assay, and examination categorized by complexity. Using the seven criteria specified in this paragraph for categorizing tests of moderate or high complexity, each specific laboratory test system, assay, and examination will be graded for level of complexity by assigning scores of 1, 2, or 3 within each criteria. The score of ``1'' indicates the lowest level of complexity, and the score of ``3'' indicates the highest level. These scores will be totaled. Test systems, assays or examinations receiving scores of 12 or less will be categorized as moderate complexity, while those receiving scores above 12 will be categorized as high complexity. Note: A score of ``2'' will be assigned to a criteria heading when the characteristics for a particular test are intermediate between the descriptions listed for scores of ``1'' and ``3.'' (1) Knowledge. (i) Score 1. (A) Minimal scientific and technical knowledge is required to perform the test; and (B) Knowledge required to perform the test may be obtained through on-the-job instruction. (ii) Score 3. Specialized scientific and technical knowledge is essential to perform preanalytic, analytic or postanalytic phases of the testing. (2) Training and experience. (i) Score 1. (A) Minimal training is required for preanalytic, analytic and postanalytic phases of the testing process; and (B) Limited experience is required to perform the test. (ii) Score 3. (A) Specialized training is essential to perform the preanalytic, analytic or postanalytic testing process; or (B) Substantial experience may be necessary for analytic test performance. (3) Reagents and materials preparation. (i) Score 1. (A) Reagents and materials are generally stable and reliable; and

(B) Reagents and materials are prepackaged, or premeasured, or require no special handling, precautions or storage conditions.

(ii) Score 3. (A) Reagents and materials may be labile and may require special handling to assure reliability; or (B) Reagents and materials preparation may include manual steps such as gravimetric or volumetric measurements.

(4) Characteristics of operational steps. (i) Score 1. Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled.

(ii) Score 3. Operational steps in the testing process require close monitoring or control, and may require special specimen preparation, precise temperature control or timing of procedural steps, accurate pipetting, or extensive calculations.

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[[Page 517]] (5) Calibration, quality control, and proficiency testing materials.

(i) Score 1. (A) Calibration materials are stable and readily available; (B) Quality control materials are stable and readily available; and (C) External proficiency testing materials, when available, are stable.

(ii) Score 3. (A) Calibration materials, if available, may be labile; (B) Quality control materials may be labile, or not available; or (C) External proficiency testing materials, if available, may be labile. (6) Test system troubleshooting and equipment maintenance. (i) Score 1. (A) Test system troubleshooting is automatic or self-correcting, or clearly described or requires minimal judgment; and (B) Equipment maintenance is provided by the manufacturer, is seldom needed, or can easily be performed. (ii) Score 3. (A) Troubleshooting is not automatic and requires decision-making and direct intervention to resolve most problems; or (B) Maintenance requires special knowledge, skills, and abilities. (7) Interpretation and judgment. (i) Score 1. (A) Minimal interpretation and judgment are required to perform preanalytic, analytic and postanalytic processes; and (B) Resolution of problems requires limited independent interpretation and judgment; and (ii) Score 3. (A) Extensive independent interpretation and judgment are required to perform the preanalytic, analytic or postanalytic processes; and (B) Resolution of problems requires extensive interpretation and judgment. (b) Revisions to the criteria for categorization. The Clinical Laboratory Improvement Advisory Committee, as defined in subpart T of this part, will conduct reviews upon request of HHS and recommend to HHS revisions to the criteria for categorization of tests. (c) Process for device/test categorization utilizing the scoring system under Sec. 493.17(a). (1)(i) For new commercial test systems, assays, or examinations, the manufacturer, as part of its 510(k) and PMA application to FDA, will submit supporting data for device/test categorization. FDA will determine the complexity category, notify the manufacturers directly, and will simultaneously inform both CMS and CDC of the device/test category. FDA will consult with CDC concerning test categorization in the following three situations: (A) When categorizing previously uncategorized new technology; (B) When FDA determines it to be necessary in cases involving a request for a change in categorization; and (C) If a manufacturer requests review of a categorization decision by FDA in accordance with 21 CFR 10.75. (ii) Test categorization will be effective as of the notification to the applicant. (2) For test systems, assays, or examinations not commercially available, a laboratory or professional group may submit a written request for categorization to PHS. These requests will be forwarded to CDC for evaluation; CDC will determine complexity category and notify the applicant, CMS, and FDA of the categorization decision. In the case of request for a change of category or for previously uncategorized new technology, PHS will receive the request application and forward it to CDC for categorization.

(3) A request for recategorization will be accepted for review if it is based on new information not previously submitted in a request for categorization or recategorization by the same applicant and will not be considered more frequently than once per year.

(4) If a laboratory test system, assay or examination does not appear on the lists of tests in the Federal Register notices, it is considered to be a test of high complexity until PHS, upon request, reviews the matter and notifies the applicant of its decision. Test categorization is effective as of the notification to the applicant. (5) PHS will publish revisions periodically to the list of moderate and high complexity tests in the Federal Register in a notice with opportunity for comment. [57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]

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Reimbursement by Insurance Provider

Payer UDS Lab Reimbursement

UDS Initial (Cup) Reimbursement

Total Reimbursement

Cigna $ 161.97 $ 17.53 $ 179.50

Medicare $ 327.67 $ 15.74 $ 343.41

Blue Cross Blue Shield $ 204.07 $ 75.00 $ 279.07

Humana $ 328.45 $ 14.95 $ 343.40

United Healthcare $ 172.17 $ 16.64 $ 188.81

Aetna $ 211.63 $ 22.78 $ 234.41

Works Comp $ 593.89 $ 28.52 $ 622.41

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NOTES

Wake Forest Biotech Place575 N. Patterson Avenue, Suite 430

Winston-Salem, NC 27101 • 877-722-8910 or 336-722-8910 • fax 336-722-8915

carolinachemistries.com

Documents

CLC Drugs of Abuse Booklet 9-11-12