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National Coverage Determination (NCD)

Wrong Surgical or Other Invasive Procedure Performed on a Patient

140.6

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Tracking Information

Publication Number
100-3
Manual Section Number
140.6
Manual Section Title
Wrong Surgical or Other Invasive Procedure Performed on a Patient
Version Number
1
Effective Date of this Version
01/15/2009
Ending Effective Date of this Version
Implementation Date
07/06/2009
Implementation QR Modifier Date

Description Information

Benefit Category
Diagnostic Tests (other)
Federally Qualified Health Center Services
Home Health Services
Inpatient Hospital Services
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services
Rural Health Clinic Services
Skilled Nursing Facility


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

In 2002, the National Quality Forum (NQF) published “Serious Reportable Events in Healthcare: A Consensus Report"1, which listed 27 adverse events that were “serious, largely preventable and of concern to both the public and health care providers.” These events and subsequent revisions to the list became known as “never events.” This concept and need for the proposed reporting led to NQF’s “Consensus Standards Maintenance Committee on Serious Reportable Events,” which maintains and updates the list which currently contains 28 items. Among surgical events on the list is “Wrong surgical procedure performed on a patient.” Similar to any other patient population, Medicare beneficiaries experience serious injury and/or death if wrong surgeries are performed and may require additional healthcare in order to correct adverse outcomes resulting from such errors.
Indications and Limitations of Coverage

B. Nationally Covered Indications

N/A

C. Nationally Non-Covered Indications

The CMS does not cover a particular surgical or other invasive procedure to treat a particular medical condition when a practitioner erroneously performs a different procedure on a Medicare beneficiary because that particular surgical or other invasive procedure is not a reasonable and necessary treatment for the Medicare beneficiary’s particular medical condition.

A surgical or other invasive procedure is considered to be the wrong procedure if it is not consistent with the correctly documented informed consent for that patient. Emergent situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent are not considered erroneous under this decision. Also, the event is not intended to capture changes in the plan upon surgical entry into the patient due to the discovery of pathology in close proximity to the intended site when the risk of a second surgery outweighs the benefit of patient consultation; or the discovery of an unusual physical configuration (e.g., adhesions, spine level/extra vertebrae).

Surgical and other invasive procedures are defined as operative procedures in which skin or mucous membranes and connective tissue are incised or an instrument is introduced through a natural body orifice. Invasive procedures include a range of procedures from minimally invasive dermatological procedures (biopsy, excision, and deep cryotherapy for malignant lesions) to extensive multi-organ transplantation. They include all procedures described by the codes in the surgery section of the Current Procedural Terminology (CPT) and other invasive procedures such as percutaneous transluminal angioplasty and cardiac catheterization. They include minimally invasive procedures involving biopsies or placement of probes or catheters requiring the entry into a body cavity through a needle or trocar. They do not include use of instruments such as otoscopes for examinations or very minor procedures such as drawing blood.

D. Other

N/A

(NCD last reviewed January 2009.)

1 http://www.qualityforum.org/pdf/reports/sre.pdf
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
102
Coverage Transmittal Link
http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R102NCD.pdf
Revision History

07/2009 - Effective Date: 01/15/2009. Implementation Date: 07/06/2006 (TN 102) (CR6405). Transmittal 101, Change Request 6405, dated June 12, 2009 is being rescinded and replaced, to correct manual references to the Benefit Policy Manual. All other information remains the same.

06/2009 - Effective Date: 01/15/2009. Implementation Date: 07/06/2006. (TN 101) (CR6405)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Wrong Surgical or Other Invasive Procedure Performed on a Patient 1 01/15/2009 - N/A You are here
CPT 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.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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