[Congressional Record (Bound Edition), Volume 154 (2008), Part 15]
[Senate]
[Pages 20714-20715]
[From the U.S. Government Publishing Office, www.gpo.gov]




                        MEDICAL ``NEVER EVENTS''

  Mr. BARRASSO. Mr. President, this morning I would like to speak about 
medical safety, about patient care, about the cost of that care, and 
about how Medicare is dealing with this.
  In 1999, the Institute of Medicine issued a groundbreaking report on 
medical errors. The report was called ``To Err Is Human: Building a 
Safer Health System.'' The Institute of Medicine findings provoked 
heated and extensive professional and public dialog. The report left 
few doubting that preventable medical injuries occur and continue to be 
a serious problem in America.
  It identified a number of solutions, solutions to stop hospitals and 
physicians from performing unsafe practices. It also asked lawmakers to 
partner with health care providers to create and to adhere to strict, 
ambitious, quantitative and well-tracked national goals.
  The National Quality Forum Set out to do just that. The forum's 
mission is to bring people together to create health care quality 
initiatives that are safe, effective, and patient-centered.
  In 2001, the former National Quality Forum CEO first coined the term 
``never event.'' Well, he was referring to particularly shocking 
medical errors that really should never happen, medical errors such as 
surgery performed on the wrong body part, surgery performed on the 
wrong patient, or the wrong surgical procedure performed on a patient.
  By 2002, the National Quality Forum had identified 27 so-called never 
events. Now, the ``group'' is listed in six different categories: 
surgical, product or device, patient protection, care management, 
environmental, and criminal.
  The Agency for Healthcare Research and Quality says that most never 
events are very rare. They estimate that a typical hospital might have 
a wrong-site surgery case once every 5 or 10 years.
  As public reporting on health care quality gained momentum, lawmakers 
focused on eliminating never events. They did it as a way to increase 
accountability as well as to contain costs. More and more surgeons 
began physically signing the surgical site with a marking pen in the 
pre-op holding area. Now, they did this while the patient was still 
awake just to make sure everyone agreed what operation was being done 
on what body part.
  The Deficit Reduction Act of 2005 required the Secretary of Health 
and Human Services to select at least two conditions that could be 
reasonably prevented. This is where Washington went too far. The 
Washington bureaucrats identified eight conditions as never events. 
Here is the list: object left in during surgery; air embolism; blood 
incompatibility; pressure ulcers; falls and trauma; catheter-associated 
urinary tract infections; vascular catheter-associated infections; and 
surgical-site infection. Why is this important, this list of eight? 
Well, it is important because some of this list of eight conditions 
really should never happen. Some of these eight conditions, though, can 
and do occur with regularity, even under the best of circumstances.
  Well, what is the impact of the rules on patients and the medical 
profession? Medicare says it will pay to treat the underlying diagnosis 
but will not pay the hospital to treat complications from any of these 
eight conditions if the medical problem develops during the patient's 
hospital stay. For example, the patient is treated for a stroke, has no 
other complications during the hospital stay, and the hospital is paid 
a little over $5,000 by Medicare. If the same patient was to have a 
severe pressure ulcer when they arrived at the hospital in addition to 
the stroke, Medicare pays about $3,000 more for the treatment of both 
the stroke and the ulcers. But Medicare says: If the pressure ulcers 
developed after the patient arrived at the hospital, then Medicare will 
only reimburse to treat the stroke, not to treat the pressure ulcer.
  The problem with pressure ulcers is they will not show up until the 
patient has usually been in the hospital for awhile. The damage to the 
tissue occurs at the time the patient with the stroke or with a broken 
hip lies motionless at home waiting until someone finds them, as often 
happens with somebody who lives alone. The damage occurs before the 
patient is even taken to the hospital, but the hospital is going to 
lose up to $3,000 to treat the pressure ulcer regardless of the medical 
condition that caused the problem in the first place. The bureaucrats 
are saying it should never happen, yet it happens all the time.
  Although the never events program is in its infancy, I am troubled by 
the direction these Washington bureaucrats are headed. I believe the 
negative long-term impact on patient care is going to be significant. 
This year, Washington bureaucrats expanded the never events. They 
expanded the list to include even more conditions: surgical-site 
infections following elective procedures, blood sugar control, and 
deep-vein thrombosis/pulmonary embolism.
  When you take a closer look at the entire process, it does show a 
disturbing trend. I agree that a foreign object left behind inside a 
patient after surgery is an event that should never occur. The fact is 
that most of the never events on the Government's list, selected and 
targeted in the rulemaking process, are impossible to eliminate.
  These bureaucrats clearly did not fulfill their requirement in the 
Deficit Reduction Act, a requirement to choose never events that are 
reasonably preventable by applying evidence-based guidelines. To be 
reasonably preventable, the Washington bureaucrats must have peer-
reviewed, published literature showing clinicians can reduce the 
incidence of the chosen never event to zero or near zero. Current data 
shows that even when all appropriate care is administered, we do not 
know how to reduce the rates to zero or near zero of many of the 
conditions now on the list. Some patients, particularly high-risk 
folks, will develop conditions on the list regardless of how good the 
care is that they receive at the hospital.
  Here is an example. The bureaucrats have listed deep-vein thrombosis/
pulmonary embolism as a never event. Well, the best scientific studies 
on large numbers of total hip and total knee procedures--and this is 
from the time I started in medical school and we were trying to lower 
the risk of those blood clots--showed that under no circumstances, no 
matter what different treatments the best scientists have come up with, 
there is no current treatment available today worldwide that would 
decrease the blood clot risk to zero.
  Now, I want to tell you about a patient who had a broken hip, a 
broken

[[Page 20715]]

hip on the left side, and at the same time of the injury, she bruised 
her right hip but did not break it. We know that patients with either a 
broken hip or who have received an artificial hip, that right after 
surgery, for the first couple of weeks, they have an increased risk of 
getting a blood clot. We treat them with blood thinners. Still, blood 
clots happen.
  So this is a patient who was given a blood thinner. We were trying to 
find out what the right delicate balance was. We worked with an 
internist and others. We thought we had the right delicate balance for 
the right dose of medication. On her right side where she had the 
bruise, she bled into that wound, and that bruise got more blood 
accumulated, a hematoma. On the left side, the side with the broken 
hip, she got a blood clot. She was on the blood thinners and bled into 
the one side, had a blood clot on the other side, and yet they call it 
a never event. How can Washington bureaucrats say that this is a never 
event?
  Let's look at another so called never event that made the list. Many 
of the ventilator-assisted pneumonia cases I saw practicing medicine in 
Casper, WY, occurred in trauma patients. The Wyoming Medical Center is 
a centrally located trauma facility. I saw patients brought in from 
accidents that occurred around all the State.
  Many of the patients are treated and stabilized at a local hospital 
100 to 250 miles away. They are transferred to the Wyoming Medical 
Center. Trauma physicians have no way to determine whether the 
pneumonia is secondary to aspiration that occurred right there at the 
site of the accident or whether it occurred as a result of something 
that happened at the first hospital. In the physician's initial 
assessment, a pneumonia has not yet developed. It takes time before it 
shows signs. Even the Washington bureaucrats that wrote the proposed 
rule agree. The rule is clear and scientific evidence is clear that 60 
to 80 percent of ventilator-assisted pneumonia cases cannot be 
prevented. How can they call that a never event?
  I have been a doctor for 30 years. I can share lots of similar 
examples with Members. Each example begs the following question: So 
what if the never event occurs in one hospital and then the patient 
needs to be transferred to another medical facility for advanced 
specialty care? Medicare says they are not going to pay for that 
treatment. Does that mean the second physician in the second hospital 
will not get paid? If the receiving hospital will get paid but the 
first one will not, isn't that surely going to lead to more transfers 
from one hospital to another, moving the patient from a hospital where 
the hospital will not get paid to the hospital where payment will 
occur?
  Look at it on the other side. If the receiving hospital will not get 
paid for a complication that occurred at the first hospital, then why 
should they accept the patient in transfer for the care they need? Is 
there any way for hospitals to appeal the decision of the Washington 
bureaucrats? What impact will this whole process have on medical 
liability? Will this list of so-called never events lead to increased 
litigation? After all, if something is never supposed to happen because 
the Government list says it doesn't but then it happens, does that mean 
someone is at fault?
  Where guidelines and proven medical strategies exist, doctors and 
hospitals strive every day to make sure serious adverse events do not 
ever occur. Never events should never occur.
  It is important to remember that the 1999 Institute of Medicine 
report which called attention to medical errors in the first place said 
bad systems and not bad people lead to most errors. As an orthopedic 
surgeon, I have spent my entire professional career trying to make 
people better. I have been on call in the middle of the night when 
folks have been involved in traumatic accidents. There are people with 
incredible talents practicing medicine, trying to do their best, but 
government policies continue to needlessly hamstring the ability to 
help their patients. The health care of this Nation is going to be hurt 
by the direction that Washington bureaucrats are headed.
  ``Never events'' should never happen. When Washington bureaucrats 
stretch the meaning of the word ``never'' to keep from paying 
hospitals, they mislead the public and cheat our Nation's hospitals and 
health care providers. Perhaps Washington should start to focus its 
regulatory efforts on eliminating waste, fraud, and abuse in the 
Medicare system. This year alone we have seen one news report after 
another uncovering Medicare wasting American tax dollars. Medicare is 
paying billions for wheelchairs, prosthetics, canes, prescription 
drugs, and other medical supplies, as the report shows, all prescribed 
by doctors who are dead, some who died 10 years ago. The Washington 
check writers honored hundreds of thousands of these fraudulent claims. 
I wonder who is holding these bureaucrats accountable.
  In 2001, they pledged to fix the problem identified by the Health and 
Human Services Office of the Inspector General. That was 7 years ago. 
Recent reports estimate Medicare loses approximately $70 to $90 billion 
each year to waste, fraud, and abuse. This strips our health care 
system of vital resources, resources we should be devoting to care for 
the elderly, the frail, the vulnerable. Federal officials have an 
opportunity to show leadership. They could have chosen to work with 
hospitals and physicians to develop evidence-based guidelines. Instead 
they have decided to issue a rule aimed at withholding money from 
hospitals, not improving patient care.
  It is time to rethink this flawed policy. Policies must work to 
improve patient care, not to punish hospitals. Hospital doors must 
remain open.
  I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER (Mr. Nelson of Nebraska). The clerk will call 
the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. CORNYN. I ask unanimous consent that the order for the quorum 
call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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