Wrong Surgical or Other Invasive Procedure Performed on a Patient

CMS National Coverage Determination | ncd_id=327 | manual_section=140.6 | coverage_level_code=3 | national_coverage_type=True | under_review=True | lab_ncd=False

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

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. 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) Benefit Categories: 20 - Diagnostic Tests (other); 27 - Federally Qualified Health Center Services; 30 - Home Health Services; 35 - Inpatient Hospital Services; 46 - Outpatient Hospital Services Incident to a Physician's Service; 52 - Physicians' Services; 61 - Rural Health Clinic Services; 68 - Skilled Nursing Facility Transmittal: transmittal_number=102 | transmittal_issue_date=2009-07-02 | change_request_number=6405