How regulation adds layers

Secretary of HHS Kathleen Sebelius recently proudly announced that three burdensome regulations in the health care world had been changed.  In an article entitled "Reducing Red Tape to Help Hospitals Improve Care and Reduce Costs," she explained the first change:

[T]oday hospitals must have a single Director of Outpatient Services who manages all of the various outpatient services throughout the hospital. This requirement was created years ago when most of the care given in a hospital was inpatient. Back then, it made sense to have 1 person in charge. But these days, everything from arthroscopic knee surgery to tonsil removal can be done on an outpatient basis. And each of these departments oversees its own services. This has made having 1 director oversee all of these specialty directors an unnecessary administrative burden on hospitals. So as part of the proposed rules, we would do away with this requirement and allow hospitals to decide the best way to oversee and manage these patients.

Directionally, of course, this is very sensible, as are the two other changes discussed in the article. One would also allow Critical Access Hospitals in rural areas to have lab work, radiology services, and other items be done outside of the hospital.  (Who knew that they couldn't?)  The other would free up hospitals to use advanced practice registered nurses and other non-physician providers to their fullest potential.

When I ran a hospital, I became aware of the Conditions of Participation under which hospitals were eligible for federal reimbursement.  These and hundreds of other regulatory standards are immensely detailed and complicated.  It is easy to imagine how they got that way.  There were likely two main categories.  One category consisted of rules that were written because in some hospital, somewhere, something harmful happened to a patient.  This would provoke a rule.

I am guessing, for example, that the 18-inch rule came from such an incident.  What's that rule?  The purpose is to prevent storage or any other obstruction from interfering with the spray of water from a sprinkler head during a fire.  So, when your hospital is surveyed by the Joint Commission or CMS, inspectors go around measuring the top of storage containers to make sure nothing is within 18 inches of the ceiling.

This one has some logic, although it is often applied more stringently that necessary.  For example, some hospitals and inspectors apply it even where there is no chance of obstruction, e.g., when the storage area is against a wall and not in the way of a sprinkler or the spray pattern.  But that is just a minor burden.  Other rules that are not necessary can be quite expensive, or perhaps harmful.

For example, there was the one imposed by the Joint Commission in 2004 that required giving patients an antibiotic within four hours of presentation if they went to an emergency department and were discharged with a diagnosis of pneumonia.  The standard was developed after publication of 2 large retrospective studies showing an association between antibiotic timing and outcomes in patients with pneumonia.   But doctors have explained to me that this approach could also result in overuse of these medicines, in that it was not dependent on growing and identifying cultures within that amount of time, or even sufficient certainty that pneumonia was, in fact, present.  This latter point was documented in a study from the University of Connecticut School of Medicine:

What the researchers found, as reported in the July 2006 issue of the journal Chest, was that there was too much “diagnostic uncertainty” to deliver antibiotics to 22 percent of patients.

Perhaps in response to this kind of analysis, the standard was modified in 2006 to require the finding of a positive chest x-ray or CT scan during the hospitalization to confirm the diagnosis of pneumonia.  It was later modified to extend the 4 hour period to 6 hours.  But in the interim, thousands of patients received antibiotics without sufficient reason -- at a time when we are told that overuse of antibiotics is an important cause of drug resistance in bacteria.

Let's now go to the next category.

I suspect, but cannot prove, that some portion of existing rules were put in place to protect the jobs or economic interests of various constituencies.  It feels like the two mentioned above -- requiring in-house radiology and labs, and limiting the roles of advanced practice nurses -- might have originated in that way.  I imagine, too, that there are howls of complaint from affected special interests when these types of changes are proposed.

So, congratulations to the Secretary for moving in the right direction on these three items.  The fact that there were only three is indicative of how hard it is to change rules once they are put in place.