Everyone’s talking about never events, ever since CMS announced its no pay policy for never events last month. But, hey, the CMS reg just implemented a DRA provision that’s a couple years old. Not only that, the commercial P4P gang — e.g., the Leapfrog Group — already has never events policies in place that go beyond the CMS reg (including apologies and real no-pay rules).

Update 9/25/07:  In an email exchange, the Leapfrog Group’s Rachel Weissburg elaborates:  "Leapfrog supports CMS’s policy but would like to see it expand to address all 28 Serious Reportable Events. . . .  Leapfrog’s Never Events policy . . . also asks hospitals to apologize, report the event, and perform a root cause analysis – critical steps in preventing the event from ever occurring again and also healing the breach of trust between physican/hospital and patient."

Per Managed Care magazine,

The proposed CMS rule change is more limited in scope. If adopted, it will take effect on Oct. 1, 2008, and "will mean that hospitals will not benefit from higher reimbursement for [specific] conditions that were not present at the patient’s admission," says CMS spokeswoman Ellen Griffith-Cohen. "We cannot speculate how the private sector will respond."

So why the brouhaha now?  Well, chalk it up to the 800-pound gorilla nature of CMS.  And some hospital folk just get wrapped around the axle of rules like this.  Consider one of the issues on the table in today’s Boston Globe article on never events and the no-pay rule: does the rule mean a hospital can’t bill for additional surgeries required because of an HAI? Probably.  Does it mean that it has to pay a crosstown rival’s bills if a patient with an HAI wants to go elsewhere for followup treatment?  Hmm.

Yes, there are issues to be ironed out, but the core concept is a sound one. 

What I find fascinating here is that in an arena where the regulated community is basically saying that "never" is a mighty tough standard, there has been no discussion of a "substantial compliance" standard, a la OBRA ’87.  (If there has been and I’ve missed it, please clue me in.)

Anyone out there know what I’m talking about?  HCFA — predecessor to CMS — and the regulated community took ten years and a bajillion pages of comments to hash out a regulatory scheme designed to implement a zero tolerance statutory scheme governing nursing facility survey and certification. (Echoes of never events.)  In the real world, the statutory standard of absolute "compliance" with Medicare conditions of participation morphed into "substantial compliance."  Maybe, at first blush, that seems incompatible with the concept of never events.  However, it seems to me that some real-world testing of the never event concept needs to happen, including an approach that recognizes that not all never events can be tied to medical errors, just as the lawyer-bashers out there (come, come, you know who you are) would have it that not all bad outcomes can be tied to negligence or malpractice.

While the core concept may be sound, another argument against no-pay for never events is that the dollars at stake are not significant enough to get hospitals’ attention.  Lest that be construed as an invitation to add more never events to the list and add penalties to withholding of payment, let me simply suggest that CMS and other payors could get more bang for the buck in other quality initiatives.

HAI is just one of the many never events flagged by both Leapfrog and CMS.  Massachusetts’ Department of Public Health has been wrestling with the issue as well, as illustrated by a recent report on HAI in Massachusetts.  Last week, DPH revealed (in a presentation by Paul Dreyer to the Public Health Council) that it would like to expand its hospital surveyor staff and add review of infection control policies, practices and outcomes — and sharing of best practices across institutions — to the work of the survey teams.  Like the Leapfrog initiative, this approach is focused on rooting out the bad and nurturing the good.  And it seems that it can be more positive than punitive.

David Harlow