Issuu

Drugs of Abuse

2012

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

carolinachemistries.com

Table of Contents Executive 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...................................................................37 Centers for Medicare & Medicaid Services â€“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 Expenses Setting 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. Financial All 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.

CLC720

Chemistry Analyzer

• 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

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.

CLC720 Chemistry Analyzer Test Menu Acetaminophen Acid Phos Albumin Alcohol Alk Phos ALT Amikacin Ammonia Amphetamine Amylase APO A1 APO B ASO AST Barbiturate Benzodiazepine BUN BUN, urine C3 C4 Calcium Calcium, urine Cannabinoid Carbamazepine Chloride Chloride, urine Cholesterol Cholinesterase CK CK-MB CO2 Cocaine Cotinine Creat, urine Creatinine CRP

CRP wide-range Cystatin C D-dimer Digoxin Direct Bilirubin Enzymatic Fibrinogen Fructosamine Gentamicin GGT Glucose Glucose, urine GlycoMark™ Haptoglobin HBD HDL-direct HbA1c Homocysteine hsCRP IgA IgG IgM Insulin Iron Lactate LP(a) LDH LDL-direct Lidocaine Lipase Lithium Magnesium Methadone Methaqualone Microalbumin NAPA

Opiate Oxycodone Pancreatic Amy Phenobarbital Phenytoin Phosphorus Phosphorus, urine Plac® Test Potassium Potassium urine Prealbumin Primidone Procainamide Propoxyphene Quinidine RF Salicylate Sodium Sodium,urine Theophylline Thyroxine (T4) TIBC TIBC Direct Tobramycin Total Bile Acids Total Bilirubin Total Protein, urine Transferrin Tricyclic Triglycerides T-Uptake UIBC Uric Acid Uric Acid, urine Valproic Acid Vancomycin Plac® Test is a registered trademark of diaDexus.

DRUGS OF ABUSE 6-AM Acetaminophen Alcohol (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)* ADULTERANTS Adulterants Aldehyde BUN Chromate Reagent Halogen Nitrite Oxidant pH reagent Specific Gravity and more... * for forensic use

carolinachemistries.com

CLC720

Chemistry Analyzer

carolinachemistries.com

CLC480 Chemistry Analyzer Routine chemistry. Special chemistry. Drugs of abuse.

7 510K Pending

CLC480

Chemistry Analyzer

• Discrete, random access, fully automated • 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 • STAT capabilities • 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. 8

The CLC480 has the most extensive menu of the benchtop chemistry analyzer market. CLC480 Chemistry Analyzer Test Menu Acetaminophen Acid Phos Albumin Alcohol Alk Phos ALT Amikacin Ammonia Amphetamine Amylase APO A1 APO B ASO AST Barbiturate Benzodiazepine BUN BUN, urine C3 C4 Calcium Calcium, urine Cannabinoid Carbamazepine Chloride Chloride, urine Cholesterol Cholinesterase CK CK-MB CO2 Cocaine Cotinine Creat, urine Creatinine CRP

Phencyclidine (PCP) Propoxyphene (PROX) Salicylate (SAL) Tapentadol) (TAP)* Tricyclics (TCA) Tramadol (TRAM)* Zolpidem (ZOL)* ADULTERANTS Aldehyde BUN Chromate Reagent Halogen Nitrite Oxidant pH reagent Specific Gravity and more... * for forensic use

carolinachemistries.com

CLC480

Chemistry Chemistry Analyzer Analyzer Technical Technical Specifications Specifications

System function:

Reaction System:

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

Optical source:

Bi-chromatic Automatic, discrete, random access Automatic cell blank correction

Analysis: Number of test items onboard: Throughput: Analysis method:

Optical source:

36+3 (ISE) 240 photometric plus 160 ISE, 400 tests/hour

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

Endpoint, rate, ISE, Turbidimetry

Reaction:

Stat interruption

Cuvette washing:

Calculated results Auto dilution and rerun of out-of-range results

Reagent mixing:

Displays graphic reaction curve Alkaline, acid, automatic 10-step, high temp, cuvette washing Dual chamber cuvette reagent mixing

Sample pre-dilution (1/10) Antigen excess detection

User interface: Software:

Sample handling: Sample type: Sample container: Number of samples onboard:

STAT capabilities:

Bidirectional LIS interface – RS-232 Serum, plasma, urine, CSF

Automatically programs patient ID and tests

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

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

55 position sample tray

Levy Jennings QC monitoring

3 to 30µL sample size

Water, wash and waste alarms

Sample volume level detection

Water/drain – self contained Preventative maintenance screen

STAT sample priority Power supply:

Reagents:

Dimension: Number onboard:

Windows® XP based

Weight:

36 tests onboard

AC 100/115/230 volt (50/60 Hz) 31.5” x 26.5” x 20.5” (W x D x H) Approx. 210 lbs.

Liquid ready-to-use Barcoded Tracks test remaining 30-day onboard stability

Calibration:

Warranty:

One year

Support:

877-722-8910

Chemistry – 14-day stability ISE – 24-hour stability Single point, multi-point Linear, spline, logit-log CC480.rv2dgtl.0812

10 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

carolinachemistries.com

BioLis24i Chemistry Analyzer Routine chemistry. Special chemistry. Drugs of abuse.

11 510K Pending

BioLis24i

Chemistry Analyzer

The versatility of use in varying laboratory environments puts the BioLis24i above all others in its class. 12

The BioLis24i has the most extensive menu of the benchtop chemistry analyzer market. BioLis24i Chemistry Analyzer Test Menu Acetaminophen Acid Phos Albumin Alcohol Alk Phos ALT Amikacin Ammonia Amphetamine Amylase APO A1 APO B ASO AST Barbiturate Benzodiazepine BUN BUN, urine C3 C4 Calcium Calcium, urine Cannabinoid Carbamazepine Chloride Chloride, urine Cholesterol Cholinesterase CK CK-MB CO2 Cocaine Cotinine Creat, urine Creatinine CRP

carolinachemistries.com

BioLis24i

Chemistry Analyzer Technical Specifications

System function:

Reaction System:

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

Optical source:

Bi-chromatic Automatic, discrete, random access Automatic cell blank correction

Analysis: Number of test items onboard: Throughput: Analysis method:

Optical source:

36+3 (ISE) 240 photometric plus 160 ISE, 400 tests/hour

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

Endpoint, rate, ISE, Turbidimetry

Reaction:

Stat interruption

Cuvette washing:

Calculated results Auto dilution and rerun of out-of-range results

Reagent mixing:

Displays graphic reaction curve Alkaline, acid, automatic 10-step, high temp, cuvette washing Dual chamber cuvette reagent mixing

Sample pre-dilution (1/10) Antigen excess detection

User interface: Software:

Sample handling: Sample type: Sample container: Number of samples onboard:

STAT capabilities:

Bidirectional LIS interface – RS-232 Serum, plasma, urine, CSF

Automatically programs patient ID and tests

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

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

55 position sample tray

Levy Jennings QC monitoring

3 to 30µL sample size

Water, wash and waste alarms

Sample volume level detection

Water/drain – self contained Preventative maintenance screen

STAT sample priority Power supply:

Reagents:

Dimension: Number onboard:

Windows® XP based

Weight:

36 tests onboard

AC 100/115/230 volt (50/60 Hz) 31.5” x 26.5” x 20.5” (W x D x H) Approx. 210 lbs.

Liquid ready-to-use Barcoded Tracks test remaining 30-day onboard stability

Calibration:

Warranty:

One year

Support:

877-722-8910 Remote diagnostics available

Chemistry – 14-day stability ISE – 24-hour stability Single point, multi-point Linear, spline, logit-log BioLis24i.rv1dgtl.0812

14 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

CLC720 CALIBRATION CURVE Test:

AMPH2

Rule:

Spline

Date/Time: 8/9/2012 2:05:57 PM

Calibration Curve

Absorbance 4900 4600 4300 4000 3700

INSTRUMENTED IMMUNOASSAY IMPROVES SENSITIVITY

3400 3100 2800 2500 2200 1900 0

100

200

300

400

500

600

700

800

900 1000 1100

1200 1300 1400 1500 1600 1700 1800 1900 2000 Concentration

CALIBRATION DATA Calibrators

Blank MDAU Low MDAU Cutoff MDAU Med MDAU High

Concentration

0 500 1000 1500 2000

Absorbance

2440 3292 3903 4265 4556

CLC480 / CLC720 MENU Drugs of Abuse 6-AM ACET AMPH BARB BENZ BUP CARI* COCM EDDP ETG

TCA THC TRAM* XTSY ZOL* Adulterants Aldehyde BUN Cromate Reagent

ETOH FENT* MEP* METD OP OXYC PCP PROX SAL TAP*

Halogen Nitrite Oxidant pH reagent UCREA Specific Gravity and more... * for forensic use

Reagents

ALB ALP ALT AST Amylase APO A1 APO B Bile Acid BUN CA

CHOL CK CO2 CREA CRP DBIL FRUC GGT Glycomark GLU

HbA1c HDLD HYC Insulin Iron LDH LDLD Lipase Lithium Lp(a) MAIB

MG PO4 RF TBIL TIBC TP Transferrin TG Uric Acid Plac速 Test

CAROLINA LIQUID CHEMISTRIES 575 N. PATTERSON AVE. SUITE 430 WINSTON-SALEM, NC 27106 TEL. 336-722-8910 Name: Carolina Liquid Chemistries Patient ID No.: CC 010101 Date of Birth: 01-01-1956 Age: 55 years Doctor: Draw Date: 01-01-2012 04:37PM

SSN: 111-11-1111 Comment 1: Hemolysis: Comment 2:

Sex: Female

Lipemia:

Test Name

Result

Units

AMPH

ng/mL

0 – 1000

BARB

ng/mL

0 – 200

BENZ

ng/mL

0 – 200

COCM

ng/mL

0 – 300

ETHA

0 119

ng/mL

0 – 100

ng/mL

0 – 300

OP300

1421H

ng/mL

0 – 300

PCP

ng/mL

0 – 25

PROX

ng/mL

0 – 300

THC50

ng/mL

0 – 50

OXYC

202

ng/mL

0 – 300

XTSY

ng/mL

0 – 500

UCRE

ng/mL

40 – 260

CUP

ng/mL

0 – 10

6 AM

ng/mL

0 – 10

METD

Flag

Fasting:

Reference Range

-- End of Report –

Reviewed by:_____________________ Page 1 Printed 08-10-2012

Date:_______________

SSN: 111-11-1111

Patient ID No: CC 010101 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

__ No drugs of abuse detected __ Consistent with potential aberrant behaviors V71.09

__ Barbiturates (ELISA) __ Ketamine __ Oxycodone __ Benzodiazepines (Class)

__ No medication reaches threshold of positive today

__ MDA

__ Corrective action required. Consider: __ Restriction of interval between visits

__ MDEA __ Propoxyphene __ Carisoprodol __ Meparidine __ THC (ELISA) __ Cocaine

__ Cognitive Behavioral Counseling __ Physician Counseling or Referral

__ Methemphetamine __ Ectasy (MDMA) __ Methadone

__ Fentanyl

__ Opiods (Class)

__ Phencyclidine (PCP) __ Buprenorphine

__ Tramadol __ 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

News Flash â€“ 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 MattersÂŽ 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.

Page 1 of 4

MLN Matters® Number: SE1105

Related Change Request Number: N/A

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-ofcare 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.

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.

Page 2 of 4

MLN Matters® Number: SE1105

Related Change Request Number: N/A

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. 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.

Page 3 of 4

MLN Matters® Number: SE1105

Related Change Request Number: N/A

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 tollfree 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.

Page 4 of 4

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

Estimated Profit

# of Profiles / Day

Profit / Year **

$ 110,900

$ 278,000

$ 445,000

$ 613,000

$ 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 Liver Profile Renal

Reimbursement 11.29 12.00

CPT Code 80076 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.

Additional Expenses for a High Complexity Lab

Profitability Semi-Quantitative Screen* Carolina Liquid Chemistries Analyzers DAU Volume

Estimated Profit

# of Profiles / Day

Profit / Year **

TC/R Profile***

$ 1,079,210

$ 68.26

$ 2,245,281

$ 51.56

$ 3,411,352

$ 45.99

$ 4,577,423.99

$ 43.20

$ 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 Liver Profile Renal

Reimbursement 11.29 12.00

CPT Code 80076 80069

High Complexity Laboratories

Quick Reference ICD-9 Codes Associated with Drugs of Abuse Panels and Drug Screen Panels 291.1 291.2 291.3 291.4 291.5 291.8 291.9 292.1 292.11 292.8 292.82 292.83 292.84 292.9 295.0 295.1 295.6 295.7 296.0 296.9 296.99 297.0 297.1 297.9 298.0 298.1 298.2 298.3 298.4 298.8 298.9 300.0 300.00 300.01 300.02 300.09 300.11 300.13 300.15 300.19 300.4 300.5 300.9 301.0 301.3 304.0 304.1

Alcohol amnestic syndrome Alcohol dementia, other Alcohol withdrawal with hallucinosis Idiosyncratic alcohol intoxication Alcoholic jealousy Other specified alcoholic psychosis Unspecified alcoholic psychosis Paranoid and/or hallucinatory states induced by drugs Drug-induced organic delusional syndrome Other specified drug-induced mental disorders Drug-induced dementia Drug-induced amnestic syndrome Drug-induced organic effective syndrome Unspecified drug-induced mental disorder Schizophrenic disorders. Simple type Schizophrenic disorders. Disorganized type Schizophrenic disorders. Residual schizophrenia Schizophrenic disorders. Schizo-affective type Affective psychoses. Manic disorder, single episode Affective psychoses. Other and unspecified affective psychoses Affective psychoses. Other specified affective psychoses Paranoid state, simple Paranoia Unspecified paranoid state Depressive type psychosis Excitative type psychosis Reactive confusion Acute paranoid reaction Psychogenic paranoid psychosis Other and unspecified reactive psychosis Unspecified psychosis Neurotic disorders. Anxiety states Anxiety state, unspecified Panic disorder Generalized anxiety disorder Anxiety sate. Other. Hysteria. Conversion disorder Hysteria. Psychogenic fugue Hysteria. Psychogenic Dissociative disorder or reaction, unspecified Hysteria. Other and unspecified factitious illness Neurotic depression Neurasthenia Unspecified neurotic disorder Paranoid personality disorder Explosive personality disorder Drug dependence. Opioid type dependence Drug dependence. Barbiturate and similarity acting sedative or hypnotic dependence

ICD-9 Codes Continued 304.2 304.3 304.4 304.7 304.8 304.9 305.2 305.4 305.5 305.6 305.7 305.8 305.9 345.1 345.3 345.9 780.0 780.01 780.02 780.1 780.2 780.3 780.39 785.0 785.1 786.50 796.0

Cocaine dependence Cannabis dependence Amphetamine and other psychostimulant dependence Combinations of opioid type drug with any other Combinations of drug dependence excluding opioid type drug Unspecified drug dependence Cannabis abuse Barbiturate and similarly acting sedative or hypotonic abuse Opioid abuse Cocaine abuse Amphetamine or related acting sympathomimetic abuse Antidepressant type abuse Other, mixed or unspecified drug abuse Epilepsy. Generalized convulsive Epilepsy. Grand mal status Epilepsy, unspecified General symptoms. Alteration of consciousness Coma Transient alteration of awareness Hallucinations Syncope and collapse Convulsions Other convulsions Symptoms involving cardiovascular system. Tachycardia, unspecified Palpitations Chest pain, unspecified 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 payersâ€™ 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.

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.

Quick Reference List â€“ 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 Opiates Cocaine Amphetamines Barbiturates Benzodiazepines Methadone PCP THC Propoxyphene Oxycodone Ecstasy Buprenorphine Urine Creatinine Alcohol

Qualitative 83925 82520 82145 82205 80154 83840 83992 80299-91 83925 80299-91 80299-91 83925 82570 82055

Opiates Cocaine Amphetamines Barbiturates Benzodiazepines Methadone PCP THC Propoxyphene Oxycodone Ecstasy Buprenorphine Urine Creatinine Alcohol

G0431 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 82570 82055

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

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 pointof-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:

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.

[[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]

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

NOTES

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

carolinachemistries.com