L28810-LCD

Automated World Health

Local Coverage Determination (LCD) for Creatine Kinase (CK), (CPK) (L28810)

Contractor Information

Contractor Name First Coast Service Options, Inc. opens in new window

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28810

LCD Title Creatine Kinase (CK), (CPK)

Contractor's Determination Number A82550

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy N/A

Indications and Limitations of Coverage and/or Medical Necessity

Creatine kinase (CK or CPK) is an enzyme found in heart muscle (CK-MB), skeletal muscle and heart (CK-MM), and brain (CK-BB). The MM fraction is present in both cardiac and skeletal muscle, but the MB fraction is much more specific for cardiac muscle. Therefore, elevation in total CK is not specific for myocardial injury, because most CK is located in skeletal muscle. Elevations in total CK are possible from a variety of non-cardiac conditions, such as muscle disease, stroke, hypothyroidism, and may even be elevated after normal exercise. Other cardiac biomarkers (i.e., troponin, myoglobin) may be used in place of or in addition to CK to determine if there is myocardial damage.

Statins are low-density lipoprotein (LDL) lowering drugs that are widely used in clinical practice. The use of statins may produce muscle toxicity under some circumstances. Therefore, it would be expected that a baseline measurement of CK would be done prior to initiating statin therapy, as well as, titration of statin therapy or with clinical signs and symptoms of myopathy (i.e., muscle discomfort, weakness, brown urine, etc.). However, medical literature does not support routine monitoring of CK in the absence of clinical signs and symptoms.

Medicare will consider a CK test to be medically reasonable and necessary for the following conditions:

• Acute myocardial infarction

• Acute cerebrovascular disease

• Myocarditis

• Myositis

• Rhabdomyolysis

• Stroke

• Central nervous system trauma

• Neuroleptic malignant syndrome

• Muscle disease

• Rheumatoid arthritis

• Hypothyroidism

• Hypokalemia

• Malignant hyperthermia

• Alcoholic liver disease

• Acute renal failure

• Signs and symptoms of cardiac disease (i.e., chest pain, nausea, shortness of breath)

• Signs and symptoms of side effects from statin medications (i.e., muscle pain, tenderness, or weakness)

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient

014x Hospital - Laboratory Services Provided to Non-patients

021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient

072x Clinic - Hospital Based or Independent Renal Dialysis Center 085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0301 Laboratory - Chemistry

CPT/HCPCS Codes

82550 CREATINE KINASE (CK), (CPK); TOTAL

82552 CREATINE KINASE (CK), (CPK); ISOENZYMES

82553 CREATINE KINASE (CK), (CPK); MB FRACTION ONLY

82554 CREATINE KINASE (CK), (CPK); ISOFORMS

ICD-9 Codes that Support Medical Necessity XX000 Not Applicable

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Documentation must support that the services were ordered by a physician/non-physician practitioner, the service was performed, and the reason the service was performed. Documentation must support the medical necessity of services performed above the utilization parameters stated below.

Appendices

Utilization Guidelines The frequency at which a CK test is performed is dependent on the clinical presentation of the patient. It is expected that a CK would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity. Literature supports performing a CK for the following:

• Chest pain/cardiac symptoms on arrival at the emergency room, with follow-up test at established intervals for a total of three CK tests

• A patient presenting to the physician’s office with chest pain/cardiac symptoms to rule out cardiac involvement

• Prior to initiating statin therapy and for titration of medication. However, if the patient is asymptomatic and has two normal results returned, it would not be expected to repeat this test routinely.

Sources of Information and Basis for Decision

Bristol-Myers Squibb Company (2003). Package insert for Pravachol (Pravastatin Sodium), including indications, warnings, precautions, and side-effects.

National Guideline Clearinghouse. Guidelines on the diagnosis and treatment of acute heart failure. Retrieved from the web on 3/23/06, located at www.guideline.gov/summary/summary.aspx?doc_id=004184

National Guideline Clearinghouse. Guidelines on managing abnormal blood lipids. A collaborative approach. Retrieved from the web on 3/23/06, located at www.guideline.gov/summary/summary.aspx?doc_id=8463

Lab Tests Online (2004). Cardiac biomarkers. Retrieved from the web on 3/28/06, located at http://www.labtestsonline.org/understanding/analytes/cardiac_biomarkers/glance.html.

Pasternak, R., Smith, S.C., Bairey-Merz, C.N., Grundy, S.M., Cleeman, J., Lenfant, C. (2002). ACC/AHA/NHLBI clinical advisory on the use and safety of statins. Journal of the American College of Cardiology, Vol. 40, No. 3, p. 567-572.

Advisory Committee Meeting Notes

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28810) replaces LCD L23091 as the policy in notice. This document (L28810) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 14 was changed 8/1/2010 - The description for Bill Type Code 21 was changed 8/1/2010 - The description for Bill Type Code 22 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 72 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0301 was changed

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

82553 descriptor was changed in Group 1

82554 descriptor was changed in Group 1

Reason for Change