It’s 2011, and America’s healthcare system is dying a death by a thousand cuts.  Each cut consists of a new rule or regulation or tweak of the payment system that adds to the physical and financial burden of taking care of sick people.  No cut in and of itself is fatal, but they are building up so quickly and so pervasively that the system itself is dying.  Each new nick reduces clinical productivity and reduces our ability to care for the ill in a financially sustainable way

One goal we have this year is to document and publicize as many of these small, but ultimately fatal blows to the system.  We’ll start with a brand new Medicare rule that may seem oh-so-minor, but will generate millions of hours of misery, expense and unproductive effort for clinicians nationwide each.  Your doctor will almost certainly be one of them.

This rule, which went into effect on January 1^st, 2011, says that each physician, physician assistant, nurse practitioner or other healthcare provider must personally sign each and every lab requisition that they wish to send to a clinical laboratory for processing.  This overturns a ten-year precedent set in 2000, when Medicare declared (and then repeatedly re-affirmed) that no such signature was required.  Furthermore, Medicare will require that each signature be an original – no rubber stamps or letter head or computerized signatures are allowed on these forms.  The requirement applies only to lab requisitions that are submitted on paper.  Requisitions submitted electronically using lab software or that are called in by the office don’t have to be signed.

Just what’s all of this about and why is it so important?

Clinical lab tests are probably the most commonly performed medical procedures on the planet.  Literally billions of them are ordered each year in the U.S. alone, and they include almost every sort of diagnostic and monitoring function that you can imagine.  Tests to count the number and type of cells in your blood.  Cultures to grow out disease-causing bacteria and viruses.  Chemistry tests to measure things like sugar, waste products, toxins, salts and acidity in bodily fluids.  Tests to look for crystals in joint fluid, cells in spinal fluid, and tuberculosis in sputum.  Doctors order lab tests for preventative medicine purposes to look for high cholesterol, diabetes and signs of cancer.  They are used to monitor the progress of treatment, whether the drugs you’re taking have reached a therapeutic or toxic level, and even if you’re taking your medicines at all.  In short, there is no aspect of modern medicine that does not rely on laboratory tests to one degree or another.  Ordering and interpreting these tests is a major part of what doctors do every day.  It’s critical to appreciate all of this because when you mess with labs, you mess with virtually the entire healthcare system.

(For the purposes of this post we’ll just look at ordering lab tests in the outpatient setting.  This is where Medicare’s new rule will have the most impact.)

How are labs ordered by doctors?  For as long as anyone can remember, the process has been the same:

1. A doctor decides that a lab test is needed.  He or she notes this in the medical record under the Assessment and Plan.  For this vast majority of medical practices, this constitutes an order to obtain the test.  If the doctor uses an electronic medical record (EMR), the EMR may print out a paper lab requisition slip that details the patient’s information and he lab tests requested.  Your doctor then immediately moves on to see his or her next patient.

2. Your doctor’s office staff then takes a look at the chart and fills out all of the paperwork needed to get you the necessary tests.  This typically involves filling out a detailed laboratory requisition of the type shown below.  As you can see, there is a lot of busywork involved with completing these forms, which is why the doctor generally doesn’t do it personally.  He simply doesn’t have the time.  Once the lab requisition is filled out, the office staff then either hands the requisition to you (the patient) to take to the lab, or obtains the samples of blood, urine or whatever to be tested and packages them up with the requisition.  The samples and requisitions are then sent to the lab for processing.

A Typical Lab Test Requisition Form

The process might seem pretty simple and old-fashioned because it is.  It’s the rare office indeed that has time to muck about with extra steps and bells and whistles when ordering labs.  There are simply too many of them, and there are too many other more important things to do for patient care.  Which gives rise to some questions about why the process isn’t even more streamlined than it is:

Q:  Why isn’t all of this done electronically?

A:  There are a couple of reasons.  First, most physicians still find that electronic medical records are expensive and inefficient to use, so they use paper-based notes and records because it’s much quicker and less expensive.  But even if you have an EMR that doesn’t necessarily mean that it’s able to create a lab requisition and send it electronically to the specific lab a patient needs.  That requires still more cost and trouble to create and implement an electronic interface between the two.  Nothing is as cheap or easy as it seems.

Q:  Can’t the lab just give you a computer that medical clinics can use to directly enter the lab request information?

A:  Well yes they can, but it’s important to understand that different patients may have to use completely different laboratories to run their tests because their health insurers insist on using one lab or another.  This means that you might be stuck installing three or four different computer ordering systems in your office, and use a different one for each patient, or even for different tests run on the same patient.  Even using a web interface is not necessarily an improvement since you still have to fill out all of the paperwork and then print out a physical requisition to accompany the lab specimen.

Q:  If Medicare wants the doctor to sign each and every lab requisition, what’s the big deal?

A:  Well it’s not such a big deal for any given requisition form.  But in aggregate it’s a huge deal because there are so many.  Once completed, each requisition will have to wait for the doctor to finish seeing their current patient.  A staff member will then need to nab him to sign the form so that the sample can be sent.  Waiting until the end of the day would make it impossible to pick up and process the specimens in a timely manner.  (Imagine if the post office had to wait until 5PM each day to pick up and start processing the mail!  It would be the same way for picking up and processing the lab specimens.)

How big a deal is it?   Let’s say that it takes an average of just thirty seconds for the doctor to interrupt what he’s doing, grab each form, sign it, and hand it back to their office staff.  And let ‘s assume that a typical provider has just 20 of these to process each day.  (This is a conservative estimate for virtually any primary care doctor.)  That’s an extra ten minutes per day, 3.33 hours per month, or 39.96 hours per year.  An entire work week for each doctor to do nothing but sign lab requisition forms! The average doctor could have seen an additional 125-175 patients during that time.  Or to put it another way, that’s about 150 patient per year who simply won’t be seen and cared for because all of those requisitions need to be signed.  There are about 880,000 clinically active physicians in the U.S., and over a million “providers” if you include physician assistants and nurse practitioners.  If just one-third (say 350,000 of them) are affected by this new rule, it amounts to 14,000,000 lost working hours and nearly 53 million patient visits that won’t be taking place.   Valuing this lost provider time at $100 per hour would raise the administrative cost of healthcare in the United States by $1.4 billion per year.

This dear reader, is not just a road, but a freeway to Hellth.

So what the heck is going on?  Why has Medicare suddenly decided to do this?  According to the CMS’ “negotiated rulemaking committee’s” entry into the Federal Register, previous Medicare rulings had specified that requisitions did not ever need to be signed as long as an order for the test was documented in the clinician’s own medical record.

“To resolve any existing confusion surrounding the implementation of the policy in 2001 and subsequent transmittals, we restated and solicited public comments on our policy in the CY 2010 PFS proposed rule (74 FR 33641). Our current policy is that a physician’s signature is not required on a requisition for clinical diagnostic laboratory tests paid on the basis of the CLFS. However, it must be evident, in accordance with our regulations at § 410.32(d)(2) and (3), that the physician ordered the services.”

CMS has been stating and re-stating this exact same thing for many years and at every opportunity.  So many times, in fact, and so adamantly that they claim that it confused people.

“During the proposed and final rulemaking process for CY 2010, we received numerous comments on these issues, including, among others: Expressions of continued confusion over the difference between an ‘‘order’’ and a ‘‘requisition’’; requests that we develop a single policy for all outpatient laboratory services, without the distinction for those paid under the CLFS or the PFS; and concerns about reference laboratory technicians who believed compelled to perform a test in order to protect the viability of the specimen although they did not have the proper documentation.”

That is to say, Medicare own policies and repeated admonitions about “having everything documented or it’s fraud” had gotten clinical laboratories so paranoid that they felt compelled to seek reassurance at every opportunity.  Medicare took this paranoia as a sign that still more paperwork must be required in order to make everyone feel better.  “Besides,” they reasoned, “it was only asking for one more little signature.”

“Therefore, in the CY 2011 PFS proposed rule (75 FR 40162), we proposed to require a physician’s or NPP’s signature on requisitions for clinical diagnostic laboratory tests paid on the basis of the CLFS. We stated that we believe that this policy would result in a less confusing process because a physician’s signature would then be required for all requisitions and orders, eliminating uncertainty over whether the documentation is a requisition or an order, whether the type of test being ordered requires a signature, or which payment system does or does not require a physician or NPP signature. We also stated that we believe that it would not increase the burden on physicians because it is our understanding that, in most instances, physicians are annotating the patient’s medical record with either a signature or an initial (the ‘‘order’’), as well as providing a signature on the paperwork that is provided to the clinical diagnostic laboratory that identifies the test or tests to be performed for a patient (the ‘‘requisition’’) as a matter of course.” [emphasis added – Ed.]

So CMS reasons that this new requirement will be no trouble at all because most doctors are already signing the requisition forms to be sent to the labs.  Really? How the heck could they understand that?  Did they actually talk to any real, actual practicing physicians before reaching this “understanding”?  Take another look at the typical requisition form that we saw earlier.  You’ll notice that there’s not even a place on the form for the physician to sign it!  Why?  Because for the past five decades, Medicare has specifically never asked or required that it be signed.  Why on Earth would physicians already be signing these stupid things “in most instances” if it’s never, ever been required previously?  CMS then went on to argue:

“Further, we stated that this policy would make it easier for the reference laboratory technicians to know whether a test is appropriately requested, and potential compliance problems would be minimized for laboratories during the course of a subsequent Medicare audit because a signature would be consistently required.”

That’s odd, because it’s not what the clinical laboratory members of the American Clinical Laboratory Association seem to think.  It’s on record as vigorously opposing the need for physician signatures on lab requisitions.  As is says on their website:

“Requiring a physician signature will be a significant change in procedure for laboratories, physicians and patients.

 

Currently, physicians are not required to sign requisitions for laboratory services. That rule was adopted in 2000, as part of a Congressionally-mandated negotiated rulemaking at which CMS and 18 organizations representing laboratories participated. All participants, including CMS, unanimously agreed that signatures should not be required and were simply one way of documenting a request for laboratory services. That rule has continued in place, without question or confusion, for over ten years. As a result, physicians simply do not sign requisitions today; rather, the requisition is handed off to nonphysician staff, who are expected to fill out the requisition pursuant to the physician’s direction. If the physician has to sign the requisition, it will add a new, and unnecessary, step to the patient encounter, disrupt the work and paper flow in the physician’s office, and could cause the patient to wait before being able to leave. Although physicians sign or initial medical records today, they may do so after the patient has left the office, often at the end of the day.

 

Similarly, laboratories currently do not have systems in place to ensure that the requisition is signed when a patient comes into the laboratory’s service center to have his or her blood drawn. Further, laboratories do not have any process to deal with the unsigned requisitions that arrive at the laboratory from the doctor’s office, along with the tens of thousands of other test requests that come in each day. Indeed, many requisitions used by laboratories today do not even have a space for the physician to sign or instructions that the physician do so. Even if CMS decides to keep the current policy in place, which we believe would be unfortunate for all the reasons set out below, there simply is no way for laboratories and physicians to comply before January 1, 2012.

 

The one person certain to be adversely affected is the Medicare beneficiary.

 

Although laboratories will not usually refuse to do testing when they receive a specimen at the laboratory, the situation is different where a patient shows up at a laboratory service center to have blood drawn. In this case, if the patient presents with an unsigned requisition, laboratories will have no choice but to request that the patient return to the physician to obtain a signed requisition (or wait while the physician’s office is contacted). This may be especially problematic for an elderly Medicare patient for whom travel is difficult, or if the patient has had to fast for some period, as is required for some testing.”

So if doctors don’t want this, and labs don’t want this, and patients aren’t asking for it, what possible justification and rationale could CMS have for implementing this policy?  Medicare’s Federal Register entry makes one lame attempt to claim that it might have something to do with “fraud and abuse”:

“Comment: The commenters [sic] suggested that a pre-printed physician signature or letterhead showing the physician’s name should serve in the place of a ‘signature.’

 

Response: A pre-printed signature or letterhead cannot be construed as a document, the contents of which a physician or NPP has affirmed. In order to discourage fraud and abuse, and to affirm that a medical service was ordered by a medical practitioner who currently works in the practice, a signature is required.”

This is nothing more than a fig leaf.  If people really wanted to defraud Medicare by ordering lots of lab tests, there are many of alternative ways to do so.  Anyone can forge a signature.  Or phone in a lab – in which case no signature is required.  And what is the evidence that substantial numbers of fraudulent lab tests are being ordered now in the absence of physician signatures?  Does CMS really think that clinic staff are ordering lots of extra tests on Medicare patients just to see what the results are?  Mightn’t doctors notice all of those unexpected lab results coming back?  Of course they would.

No.  If you think about it, the only reasonable explanation for this new requirement (aside from bureaucratic stupidity) is that it’s yet another means of covertly rationing healthcare services to the Medicare population.  The numbers speak for themselves.  Every busy, lab-requiring physician will have one full week less per year to practice medicine and therefore incur costs.  Fifty-three million potential Medicare visits will never take place.  None of those visits will generate physician fees, medical tests or prescriptions that Medicare will need to pay for.  If we assume that each of these visits might have generated an average of $200 in additional costs to Medicare, the hidden savings to CMS would total some $10.6 billion each year.  Furthermore, if labs go ahead and process lab specimens (because, after all, the patients do actually need them) but without physician signatures, Medicare won’t have to pay for the tests.  Or if it does, it can then accuse the laboratories of “fraud” for not having all of those signatures on file, and levy billions of dollars in financial penalties.   Doctors and laboratories may pay a high price for this little rule, but all of these quite tangible savings cost Medicare nothing other than a bit of ink in the Federal Register.  And American healthcare will be that much closer to dying the death of a thousand cuts.

Hmmm.  If you’re a Medicare beneficiary who happened to need one of those canceled visits, you might even have an opportunity to die along with it.