Carolina Liquid Chemistries, Drugs of Abuse Booklet

Drugs of Abuse

2012

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

www.carolinachemistries.com

Table of Contents Executive Summary 1 BioLis 24i Brochure 3-6 BioLis 24i Quick Reference Guide

7

Sample Report 8 MLN Matters: Medicare Drug Screen Testing Info.

9-12

Quick List-Drugs of Abuse Coding

13

Quick Reference: ICD-9 Codes 14-15 High Complexity Documents 17-19

Executive Summary Faster turnaround times for laboratory results means quicker time to diagnose and treat.

Prompt diagnosis and treatment saves lives… it is 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 pharmacokentic issues, substance abuse, misuse, diversion, addiction, and medical legal issues on the spot.

Carolina Liquid Chemistries Corp. (CLC) manufacturer, distributor and service provider for reagents and chemistry systems is offering the BioLis 24i as a solution for clinics in need of a vehicle to perform drug testing in their own facilities. The BioLis 24i can run over 16 drugs of abuse and over 100 different chemistry tests including renal and liver profiles. This bench top chemistry analyzer has the flexibility of performing a baseline qualitative drug test as well as a more quantitative measurement. Practices can now set up laboratories within their own facility and obtain results and make treatment decisions and medication adjustments before the patient leaves the office – rather than waiting on test results from an outside laboratory. For larger laboratories CLC can provide refurbished Olympus and Beckman 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 can connect your facility with the best experts in billing, 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 an estimate number to use to budget, per year, for fixed operational costs would be $52,000. This would include 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. Profit pictures are dependent on insurance mix and reimbursement by local carriers and Medicare.

MLN Matters article (http://www.cms.gov/MLNMattersArticles/Downloads/SE1105.pdf), this document addresses the 2011 Medicare reimbursement environment for DAUs. 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.

1

carolinachemistries.com

BioLis 24i Chemistry Analyzer Routine chemistry. Special chemistry. Drugs of abuse.

510K Pending

3

BioLis 24i

Chemistry Analyzer

• Discrete, random access, fully automated • 400 tests per hour • 100 chemistry tests available • Requires no disposable cuvettes • 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 BioLis 24i above all others in its class.

4

The BioLis 24i has the most extensive menu of the benchtop chemistry analyzer market.

BioLis 24i 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 TDMs 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

DRUGS OF ABUSE 6-AM Alcohol Amphetamine (AMPH) Barbiturate (BARB) Benzodiazepine (BENZ) Buprenorphine Cannabinoid (THC) Cocaine (COCM) Cotinine Assay Ecstasy EIA Kit ETG Methadone (METD) Opiate (OP) Oxycodone Phencyclidine (PCP) Propoxyphene (PROX) TCA (Tricyclics)

Adulterants Adulterant Cals & Controls Aldehyde Cromate reagent Halogen Nitrite Oxidant pH reagent Spec Gravity Urine Creatinine

Plac® Test is a registered trademark of diaDexus.

carolinachemistries.com

5

BioLis 24i

Chemistry Analyzer Technical Specifications

System function:

Reaction System:

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

Automatic cell blank correction

Optical source: Bi-chromatic

Automatic, discrete, random access

Analysis: Optical source: Tungsten halogen lamp

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

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

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

Analysis method: Endpoint, rate, ISE, Turbidimetry

Cuvette material: 60 self-cleaning semi-permanent cuvettes

Stat interruption

Reaction: Displays graphic reaction curve

Calculated results

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

Auto dilution and rerun of out-of-range results

Reagent mixing: Dual chamber cuvette reagent mixing

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

User interface: Software: Windows® XP based

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

Bidirectional LIS interface – RS-232

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

Automatically programs patient ID and tests Barcodes – Code 39, Code 128, ITF, NW-7

Number of samples onboard: 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

STAT capabilities: STAT sample priority

Preventative maintenance screen

Reagents:

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

Dimension: 31.5” x 26.5” x 20.5” (W x D x H) Number onboard: 36 tests onboard

Weight: 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 BioLis24i.rv1dgtl.0212

6 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

2% 2%

16.0 16.0 16.0

BL-418 2 x 100 (200)

BL-413 2 x 100 (200)

BL-415 2 x 100 (200)

BL-423 2 x 100 (200)

Carolina Tests/Kit Cat. No.

Chemistry

XTSY

BL-419 2 x 100 (200)

OXYC

Carolina Tests/Kit Cat. No.

Carolina Tests/Kit Cat. No.

Chemistry

Chemistry

BL410 2 x 100 (200)

CANNAB

BL-421 2 x 100 (200)

Carolina Tests/Kit Cat. No.

Chemistry

ETHA

BL-424 2 x 100 (200)

BUP

Carolina Tests/Kit Cat. No.

Chemistry

Carolina Tests/Kit Cat. No.

Chemistry

BL-425 2 x 100 (200)

16.0

6AM

2%

16.0 0 ng/mL

0 ng/mL

0 ng/mL

0 ng/mL

0 ng/mL

0 ng/mL

0 ng/mL

0 ng/mL

2%

0 ng/mL

4%

0 ng/mL

8%

3%

N/A

Neg Cal

0 ng/mL

2%

0 ng/mL

18.0 NA: 1%!

3%

0 ng/mL

Sample W/R Neg Cal Size uL Precision P/N 0001

8.0

Sample W/R Neg Cal Size uL Precision P/N 0001

12.0

Sample W/R Size uL Precision

16.0

Sample W/R Neg Cal Size uL Precision P/N 0001

16.0

Sample W/R Neg Cal Size uL Precision P/N 0001

16.0

Sample W/R Neg Cal Size uL Precision P/N 0299

3%

16.0

BL-411 2 x 100 (200)

BL-414 2 x 100 (200) BL-416 2 x 100 (200)

3%

2%

2%

16.0

BL-417 2 x 100 (200)

2%

16.0

Sample W/R Neg Cal Size uL Precision P/N 0001

BL-412 2 x 100 (200)

Carolina Tests/Kit Cat. No.

PCP PROX

OP

METH

COCM

BENZ

BARB

AMPH

Chemistry

DRUGS OF ABUSE High Cal P/N 0805

500 ng/mL

Cutoff Cal P/N 0163

300 ng/mL

Cutoff Cal P/N 0246

100 mg/dL

Cutoff Cal

50 ng/mL

Cutoff Cal P/N 0075

10 ng/mL

Cutoff Cal P/N 0275

10 ng/mL

Cutoff Cal P/N 0293

High Cal P/N 0165

800 ng/mL

High Cal P/N 0249

N/A

High Cal

750 ng/mL 1000 ng/mL

Mid Cal P/N 0164

500 ng/mL

Mid Cal P/N 0248

N/A

Mid Cal

150 ng/mL

High Cal P/N 0078

Mid Cal P/N P/N 0077 100 ng/mL

40 ng/mL

High Cal P/N 0278

40 ng/mL

High Cal P/N 0295

20 ng/mL

Mid Cal P/N 0277

20 ng/mL

Mid Cal P/N 0294

600 ng/mL 1000 ng/mL

300 ng/mL

100 ng/mL

50 ng/mL

25 ng/mL

NA: 100.0-200.m mmol/L!

100 ng/mL

Low Cal P/N 0162

100 ng/mL

Low Cal P/N 0243

N/A

Low Cal

20 ng/mL

Low Cal P/N 0073

5 ng/mL

Low Cal P/N 0273

5 ng/mL

Low Cal P/N 0292

150 ng/mL

12.5 ng/mL 375 ng/mL

35 ng/mL

2500 ng/mL

375 ng/mL

190 ng/mL

300 ng/mL

300 ng/mL

625 ng/mL

Control Lev 2 P/N 0808

30 days

30 days

30 days

30 days

30 days

30 days

30 days

30 days

On-Board Stability

12.5 ng/mL

30 days

13 ng/mL

30 days

62.5 ng/mL

30 days

300 ng/mL

30 days

375 ng/mL

30 days

375 ng/mL

625 ng/mL

30 days

Control Lev 1 Control Lev 2 P/N On-Board P/N 0167 0168 Stability

225 ng/mL

Control Lev 1 Control Lev 2 P/N On-Board P/N 0245 0247 Stability

50 ng/mL

Control Lev 1 Control Lev 2 P/N On-Board P/N 0224 0225 Stability

37.5 ng/mL

Control Lev 1 Control Lev 2 P/N On-Board P/N 0007 0008 Stability

7 ng/mL

Control Lev 1 Control Lev 2 P/N On-Board P/N 0274 0276 Stability

7.5 ng/mL

7 days

Calibration Frequency

7 days

Calibration Frequency

7 days

Calibration Frequency

7 days

Calibration Frequency

7 days

Calibration Frequency

7 days

Calibration Frequency

7 days

7 days

7 days

7 days

7 days

7 days

7 days

7 days

Calibration Frequency

QRGbl-001.3/REV. MAR-2011

Enzyme Immunoassay

Method

Enzyme Immunoassay

Method

Enzyme Immunoassay

Method

Enzyme Immunoassay

Method

Enzyme Immunoassay

Method

Enzyme Immunoassay

Method

Enzyme Immunoassay

Enzyme Immunoassay

Enzyme Immunoassay

Enzyme Immunoassay

Enzyme Immunoassay

Enzyme Immunoassay

Enzyme Immunoassay

Enzyme Immunoassay

Method

391 Technology Way Winston-Salem, NC 27101 877-722-8910 (Office) 336-722-8915 (Fax)

Control Lev 1 Control Lev 2 P/N On-Board P/N 0297 0298 Stability

225 ng/mL

18 ng/mL

1500 ng/mL

110 ng/mL

100 ng/mL

100 ng/mL

375 ng/mL

Control Lev 1 P/N 0807

1000 ng/mL 2000 ng/mL 4000 ng/mL 6000 ng/mL

300 ng/mL 1000 ng/mL

500 ng/mL 1000 ng/mL

500 ng/mL 1000 ng/mL

750 ng/mL 1000 ng/mL

Mid Cal P/N 0804

225 ng/mL

300 ng/mL

150 ng/mL

200 ng/mL

200 ng/mL

500 ng/mL

Cutoff Cal P/N 0803

600 ng/mL 1000 ng/mL

150 ng/mL

75 ng/mL

100 ng/mL

100 ng/mL

250 ng/mL

Low Cal P/N 0802

Reagents for use on BiOLiS 24i Clinical Analyzers

Quick Reference Guide

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Stratford medical Associates 2215 Main Street Blue Creek, OH 45616 Tel. 937-451-8597 Fax. 937-451-8532

Name: Patient ID No.: Date of Birth: Doctor: Draw Date: 08-12-2011

SSN: Comment 1: Hemolysis: Lipemia: Comment 2: Patient taking oxycodone

Test Name Results

Units Flag Reference Range

AMPH BARB BENZ ETHA THC50 OXYC XTSY

ng/mL ng/mL ng/mL ng/mL ng/mL ng/mL ng/mL

Run Date:

0 0 0 185 0 750H 0

Fasting:

08-12-2011 11:51 AM

0 - 1000 0 - 200 0 - 200 0 - 2000 0 - 50 0 - 300 0 - 500

---- End of Report ---Reviewed by: ________________

Date: _________________

Page 1 SSN: Printed: 08-12-2011 11:51 AM

Patient ID No: Lab Results for:

m a S

8

e l p

p e R

t r o

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 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

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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.

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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.

11

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.

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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Page 4 of 4

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 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 Benzodiazepine Methadone PCP THC Propoxyphene Oxycodone 59 Ecstasy Buprenorphine Urine Creatinine Alcohol

G0431 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 G0431-59 GO431G0431-59 G0431-59 82570 82055

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

13

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

14

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

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 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.

15

High Complexity Laboratories

17

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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