The Centers for Medicare and Medicaid Services (“CMS”) has issued three Coverage Decision Memorandums establishing National Coverage Determinations (NCDs) that “wrong surgeries” — surgeries on the wrong body part, surgeries on the wrong patient, and the wrong procedure — are not covered by Medicare. The wrong body party, wrong patient, and wrong procedure NCDs are effective January 15, 2009 and apply to all provider types and coverage under both Part A and Part B.
Background
CMS has recently introduced several initiatives directed towards promoting higher quality, more efficient health care delivery through value-based purchasing (“VBP”). Included in these initiatives are changes to the Inpatient Prospective Payment System (“IPPS”) to address payment for hospital-acquired conditions (“HACs”) and the introduction of these NCDs for wrong surgeries. Changes to the IPPS to address payment for HACs and the NCDs for wrong surgeries target certain “never events” included in the list of Serious Reportable Adverse Events identified by the National Quality Forum (“NQF”).
Wrong Surgeries Not Reasonable and Necessary
Items and services that “are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member” are not covered by Medicare. In the Coverage Decision Memos, CMS explains that where there is evidence that demonstrates that an item or service improves outcomes, it can be determined to be reasonable and necessary. But in the case of wrong surgeries, CMS concluded that an evidentiary review is not necessary to determine that the occurrence of wrong body part, wrong patient, or wrong procedure will not improve health outcomes, citing various studies of wrong surgeries and position statements from the NQF and the Joint Commission. The wrong body part, wrong patient, and wrong procedure coverage decisions all propose that Medicare will not cover such a surgical or other invasive procedure because it is not a reasonable and necessary treatment for patient’s particular medical condition.
Scope – Surgical or Other Invasive Procedures
The scope of the wrong body part, wrong patient, and wrong procedure coverage decisions is based upon the definition of “surgical or other invasive procedures” as established by the NQF in its list of Serious Reportable Adverse Events. “Surgical or other invasive procedures” are defined in all three of the NCDs as:
[O]perative 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 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.
Definition of Wrong Surgeries
CMS has adopted the following definitions for wrong surgeries. As with the scope of the NCDs, these definitions are based upon definitions used by the NQF in its list of Serious Reportable Adverse Events.
Wrong Body Part – A surgical or other invasive procedure is considered to have been performed on the wrong body part if it is not consistent with the correctly documented informed consent for that patient. It includes surgery on the right body part, but on the wrong location on the body; for example, left versus right (appendages and/or organs), level (spine). 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).
Wrong Patient – A surgical or other invasive procedure is considered to have been performed on the wrong patient if that procedure is not consistent with the correctly documented informed consent for that patient.
Wrong Procedure – 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).
All of the definitions incorporate informed consent documents in determining when an event has occurred and, with the exception of wrong patient, include an exception for situations where obtaining informed consent for the surgical or other invasive procedure in question is not possible due to emergency situations. Furthermore, both the wrong body part and wrong procedure coverage decisions allow coverage where divergence from informed consent results from unexpected pathology in close proximity to the surgical site or unusual physical configuration of the surgical site that presumably could not have been discovered prior to commencing the surgical or other invasive procedure.
Implementation Issues
CMS stated in the Coverage Decision Memorandums that claims processing instructions specific to the three NCDs would be prepared and released by CMS following posting of the NCDs. This will most likely be a significant source of information for providers in better understanding the practical implications of these NCDs. As of the date this article was written, the NCDs had not yet been posted and no claims processing instructions had been made available. Further updates on this topic will be posted on this listserve as more information becomes available.
If you have any questions, regarding these NCDs, or CMS policies on coverage and payment of “never events” generally, please contact the author or another member of the McGuireWoods Health Care industry group.