Saturday, January 24, 2009

New Never Events

In a sobering reminder of the challenges in eliminating preventable errors, on January 15 CMS issued three national coverage determinations (NCD) to protect patients from preventable surgical errors. These "never events" apply to surgical or other invasive procedures (sometimes collectively called "wrong site errors") including: CMS referenced a 2007 article estimating that wrong site errors might occur “once each year in a 300-bed hospital' and "surgeons who work on symmetrical structures may have a 1 in 4 chance to be involved in a wrong-site error during their careers." A 2006 study reported finding these errors in 1 of 112,994 operations. Finally, the 2006 AHRQ study reported that these errors "are extremely rare and major injury from them is even rarer."

To put the study's definition of "extremely rare" in perspective: the FAA's operational error rate (i.e., allowing two planes to be too close together) is 31% better (1 in 149,074 operations).

Effective immediately, Medicare does not cover these events, which apply to hospitals, doctors and "any other health care providers and suppliers involved in the erroneous surgeries. " This is a change in coverage limitations from some other 'never events', which had applied to hospitals only.

CMS, in an apparent moment of dark humor, stated that "instructions for processing such claims will occur at a later date." Yet CMS is quite serious about this, as only 11 states prohibit wrong-site billing.

Stories involving wrong site procedures regularly make the news such as this three time occurrence of wrong site brain surgery in Rhode Island (link on the picture):


Clarke J, Johnston J and Finley E. Getting Surgery Right. Annals of Surgery. 2007;246:395-405.

Kwaan M, Studdert D, Zinner M and Gawande A. Incidence, Patterns and Prevention of Wrong-Site Surgery. Archives of Surgery. 2006;141:353-358.

1 comment:

Anonymous said...

Yes, CMS has informed appropriate institutions (e.g. Hospitals, Clinics, etc.) many months in advance. Our organization has been holding meetings about the effects of the NCD on us. It should be said that a "Never Event" does NOT qualify for reimbursement. This is a (small) part of the CMS Value Added Purchasing Program or Pay for Performance. However, many institutions, including ours has had policies in place for years that mirror the CMS "Never Events" policy so the effect will not be as great for these institutions. There is controversy regarding what portion of the hospital stay qualifies for reimbursment in the case of a never event. Is it the entire stay or just the portion that relates to the never event itself? And then, depending on the situation, this can be subjective and subject to interpretation. As usual, this makes for a passionate discussion between healthcare institutions, their representatives (such as HANYS), and CMS as we continue to wrestle and posture.

Gennady Beyzarov
Healthcare Data Analyst
New York