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Never say never: "never events" in Medicare.

INTRODUCTION

In 2004, James Klotz suffered a heart attack. After he was admitted to the hospital, surgeons surgically implanted a pacemaker in him. (1) While he recovered from surgery in the hospital, Klotz developed a drug-resistant staph infection Staph infection
Infection with Staphylococcus bacteria. These bacteria can infect any part of the body.

Mentioned in: Cephalosporins
 that required fifteen additional operations and eighty-four additional days in the hospital. (2) Klotz subsequently "lost his right leg, part of his left foot, a kidney, and most of his hearing." (3) Klotz sued his heart surgeon for medical malpractice Improper, unskilled, or negligent treatment of a patient by a physician, dentist, nurse, pharmacist, or other health care professional. . In 2008, a jury awarded Klotz and his wife $2.5 million. (4)

Who should bear the cost when medical errors (5) such as this occur.? (6) Critics of the traditional fee-for-service reimbursement model in which physicians are paid for each service performed--argue that it focuses too heavily on the quantity of care given, without regard to quality, outcomes, or overall costs of care. (7) Thus, they argue that the traditional model is flawed because it bases a doctor's compensation on the number of services rendered, instead of the overall health of the patient. (8) In other words Adv. 1. in other words - otherwise stated; "in other words, we are broke"
put differently
, "providers [that] deliver suboptimal Suboptimal
A solution is called suboptimal if a part of the solution has been optimized without regards to the overall objective.
 care may end up earning more for subsequent consultations, hospitalizations, and procedures than those whose skill yields a quick, definitive diagnosis and cure." (9) Some commentators have suggested replacing the traditional model with a "pay-for-performance model," (l0) which would predicate In programming, a statement that evaluates an expression and provides a true or false answer based on the condition of the data.  a physician's pay upon the health of the patient treated. (11) Accordingly, the doctor would only receive payment if the treatment proved to be helpful to the patient.

Recently, academics, the government, and the media have all, in various ways, suggested that a pay-for-performance model would help reduce preventable medical errors (PMEs). Their suggestions culminated in a change of the reimbursement policy used by the Centers for Medicaid and Medicare Services (CMS (1) See content management system and color management system.

(2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system.
) and many private insurers. In October 2008, CMS halted reimbursements for eight categories of hospital-acquired conditions (HACs)--conditions that CMS determined to be serious and reasonably preventable. (12) In its 2009 final rule, CMS expanded the number to ten. (13) Generally, these conditions are widely referred to as Never Events because they are events that should ideally never happen. (14) As a result, health care payers (including CMS) subject these conditions to reduced reimbursement and/or to reporting requirements. (15)

Refusing to reimburse hospitals for a preventable class of events should, theoretically, deter hospital complacency to the occurrence of those events. (16) By making the hospital (instead of the insurance company, or, alternatively, the patient) bear the costs of a medical error, the hospital will likely take enhanced preventative measures to avoid wasted costs that would thereby reduce the occurrence of the events. (17)

This Never Events policy represents a schism in the health care community. While CMS and private insurers argue that this policy will reduce medical errors and improve quality of care, (18) other commentators have suggested that the Never Events policy will have the opposite effect and adversely affect care. (19) In particular, these entities argue that the Never Events policy will negatively affect fundamental hospital relationships, such as the physician-client relationship (20) and the hospital-physician relationship. (21) Additionally, they argue that the Never Events policy will affect malpractice insurance Noun 1. malpractice insurance - insurance purchased by physicians and hospitals to cover the cost of being sued for malpractice; "obstetricians have to pay high rates for malpractice insurance"  premiums and coverage (22) and will restrict the access of those with poor health to healthcare services. (23)

The purpose of this Note is to discuss the history of Never Events and to illuminate how these events have evolved. This Note begins by briefly explaining what Never Events are, in broad terms. Section II explains the creation and evolution of the Never Events policy--tracing it from nonprofit patient advocacy Patient advocacy refers to speaking on behalf of a patient in order to protect their rights and help them obtain needed information and services. The role of patient advocate is frequently assumed by nurses, social workers, and other healthcare providers.  organizations to the federal and state governments. Section III argues that this policy unfairly punishes hospitals by refusing to reimburse for conditions that are not preventable. Finally, Section IV recommends that CMS should revise its Never Events policy to include only conditions that hospitals can truly prevent.

I. WHAT ARE NEVER EVENTS?

At a general level, a Never Event is a preventable condition that a patient acquires at a hospital. By definition, Never Events are secondary diagnoses, which are conditions concurrent to primary conditions. (24) In other words, Never Events are conditions that are distinct from the condition for which the hospital admitted the patient. Thus, Never Events are usually thought to be conditions that patients acquire in a hospital, although, as this Note will show, this belief does not always prove to be true. (25) Accordingly, because a "Never Event" typically occurs while the patient is in the hospital, it is crucially important that hospitals correctly diagnose and classify what conditions its patients present upon admission. To this end, CMS requires that hospitals indicate when a condition is present on admission through the use of a claim code. (26) Practically, this means that hospitals must have two specialists on staff: a doctor to diagnose what conditions the patient has; and a coding specialist, who must rely on the doctor's notes to determine what claim codes CMS requires. (27)

Depending on the source, the term can refer to different conditions. For example, the National Quality Forum ("NQF NQF National Qualifications Framework
NQF National Quality Forum
NQF Norsk Quilteforbund (Norwegian Quilt Association)
NQF Neutron Quality Factor
") originally listed twenty-eight preventable medical errors that it considered Never Events, (28) whereas CMS uses the term to refer to ten categories of preventable HACs. (29)

II. THE BACKGROUND OF NEVER EVENTS

For over ten years, various policy groups have attempted to shed light on Preventable Medical Errors (PMEs). In 1999, the Institute of Medicine ("IOM IOM

See: Index and Option Market
") published To Err is Human "To Err is Human: Building a Safer Health System" is a groundbreaking report issued in 2000 by the U.S. Institute of Medicine which resulted in an increased awareness of U.S. medical errors. The push for patient safety that followed its release currently continues. : Building a Safer Health Care System. (30) In that report, the IOM relied on different studies that estimated PMEs are responsible for the deaths of up to 98,000 patients each year, (31) making medical errors a leading cause of morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
 in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . (32) In other words, PMEs lead to more annual deaths in the United States than breast cancer, motor vehicles accidents, or AIDS. (33)

In addition, the IOM estimated that the total cost of PMEs falls somewhere between seventeen and twenty-nine billion dollars. (34) In a follow-up study, the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  ("CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
") estimated that hospital-acquired infections Hospital-Acquired Infections Definition

A hospital-acquired infection is usually one that first appears three days after a patient is admitted to a hospital or other health care facility.
 cost the U.S. health care system five billion dollars annually. (35) Other studies suggest that hospitals generally do not follow the recommended guidelines to avoid preventable hospital-acquired infections. (36) Accordingly, these studies suggest that doctors and staff could significantly reduce costs, save lives, and increase care by simply practicing rigorous hygiene--including washing hands, sterilizing equipment, and other simple precautions. (37) One report in particular suggested that eighty-seven percent of hospitals fail to take the recommended steps to avoid four of the most common infections. (38)

Expectedly, these pronouncements reverberated throughout the health care community. (39) Almost immediately afterwards, policy groups began to draft and discuss solutions that would, hopefully, decrease the occurrence of PMEs. (40)

In 2002, the National Quality Forum (NQF) (41) released Serious Reportable Events in Healthcare, (42) a report that listed twenty-seven clearly identifiable and preventable medical errors that posed serious consequences for patients. (43) In 2006, NQF updated the list to include "artificial insemination artificial insemination, technique involving the artificial injection of sperm-containing semen from a male into a female to cause pregnancy. Artificial insemination is often used in animals to multiply the possible offspring of a prized animal and for the breeding  with the wrong donor sperm or wrong egg" as a Never Event, bringing the total number to twenty-eight. (44) The NQF placed each event under one of six categories, (45) including patient protection (i.e., infant discharged to the wrong person), criminal events (i.e., sexual assaults on patients in a healthcare setting), and surgical events (i.e., surgery performed on the wrong body part), among others. (46)

Notably, the NQF primarily sought to establish a consensus among healthcare stakeholders about which events to select. (47) To facilitate this, NQF adopted a rigorous screening process to each proposed event and sought a consensus from physicians, hospitals, and healthcare providers, including "public and private purchasers; national, regional, state, and local groups representing consumers; accrediting bodies; supporting industries; and organizations involved in healthcare research or quality improvement." (48)

The 2006 NQF report termed these conditions "serious reportable events" or Never Events, indicating that these events should never happen in a hospital. (49) In reality, NQF applied a lower than "never" standard--stating that the conditions need be "largely preventable, and very serious." (50) NQF hoped that the list would be the basis for a nationwide reporting system that would subsequently reduce the occurrence of these events. (51)

Soon after, other organizations began to support similar initiatives. For example, the Leapfrog Group for Patient Safety52 endorsed the NQF's list of Never Events. (53) Additionally, Leapfrog announced that it would publicly recognize hospitals that: (1) apologized to the patient/family affected by the event; (2) reported the event to at least one reporting agency; (3) performed a root cause analysis; and (4) waived all costs directly related to the event. (54) Leapfrog has subsequently encouraged its members to support its policy, leading to public support of the plan by Aetna, GM, IBM (International Business Machines Corporation, Armonk, NY, www.ibm.com) The world's largest computer company. IBM's product lines include the S/390 mainframes (zSeries), AS/400 midrange business systems (iSeries), RS/6000 workstations and servers (pSeries), Intel-based servers (xSeries) , and others. (55)

States also adopted similar policies. In 2003, Minnesota began requiring hospitals to report the original twenty-eight Never Events as described by the NQF. (56) As of July 2008, nearly half of the hospitals participating in a Leapfrog survey have adopted Leapfrog policies. (57) In addition, hospital associations from Vermont, Massachusetts, and Washington have since agreed to stop billing for all or part of the errors identified by NQF. (58) State Medicaid programs have also begun to follow suit. For example, both Pennsylvania and New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 announced that they would terminate reimbursement for PMEs because they were not medically necessary medically necessary Managed care adjective Referring to a covered service or treatment that is absolutely necessary to protect and enhance the health status of a Pt, and could adversely affect the Pt's condition if omitted, in accordance with accepted  to treat illnesses. (59)

Private insurers have also taken notice of Never Events. Well-Point and CIGNA CIGNA CG (Connecticut General Life Insurance Company) INA (Insurance Company of North America)  announced that they would cease to pay hospitals when "serious preventable errors" occur. (60) Specifically, CIGNA would discontinue payments for conditions that could have been avoided by use of widely accepted industry standard procedures. (61)

The Federal Government soon began to take similar actions to reduce preventable medical errors. Most notably, Congress passed the Deficit Reduction Act of 2005 (62) ("DRA DRA Delta Regional Authority
DRA Developmental Reading Assessment (educational test)
DRA Division of Ratepayer Advocates (California)
DRA Data Research Associates
DRA Directory and Resource Administrator
"), which aimed to cut Medicaid and Medicare expenses by requiring the Secretary of Human Health and Services to choose at least two "high-cost or high-volume" preventable, hospital-acquired conditions that the CMS would no longer reimburse. (63) The DRA required that any the condition had to meet at least two out of the three guidelines:

(1) be either high cost, high volume, or both;

(2) be reasonably preventable through the application of evidence-based guidelines; (64) and

(3) have a diagnosis code that clearly identified the condition and assigned the patient to a higher pay rate. (65)

In its 2008 proposed rule, CMS initially considered adopting fourteen categories of HACs that the CMS would exclude from reimbursement and invited the public to comment to ensure that the events complied with the standards set by the DRA. (66) CMS further distinguished four of the proposed HACs as "serious preventable events" (67) because these conditions originated from the NQF's original list of Never Events. (68)

These conditions are as follows: leaving an object in a patient; performing the wrong surgery on a patient (surgery on the wrong body part, wrong patient, or the wrong surgery); failing to prevent air embolisms following certain surgeries; and providing incompatible blood or blood products to patients. (69)

In its 2008 Final Rule, CMS responded to the public comments and chose the following categories of HACs: (1) catheter-associated urinary tract infection urinary tract infection (UTI),
n infection in one or more of the structures that make up the urinary system. Occurs more often in women and is most commonly caused by bacteria.
 (UTI UTI urinary tract infection.

UTI
abbr.
urinary tract infection



UTI

urinary tract infection.

UTI Urinary tract infection, see there
); (70) (2) pressure ulcers; (71) (3) serious preventable event--foreign object left in the body after surgery; (4) serious preventable event--air embolism embolism

Obstruction of blood flow by an embolus—a substance (e.g., a blood clot, a fat globule from a crush injury, or a gas bubble) not normally present in the bloodstream. Obstruction of an artery to the brain may cause stroke.
; (72) (5) serious preventable event--blood incompatibility; (6) vascular catheter-associated infection; (7) falls/burns/crushing injuries; and (8) surgical site infections following coronary artery bypass graft surgery Coronary Artery Bypass Graft Surgery Definition

Coronary artery bypass graft surgery is a surgical procedure in which one or more blocked coronary arteries are bypassed by a blood vessel graft to restore normal blood flow to the heart.
. (73)

The next year, CMS selected two additional conditions--manifestations of poor control of blood sugar level and deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen.  (pulmonary embolism Pulmonary Embolism Definition

Pulmonary embolism is an obstruction of a blood vessel in the lungs, usually due to a blood clot, which blocks a coronary artery.
). (74) CMS also expanded the category of "Surgical Site Infections" to include infections following certain elective procedures. (75) With the addition of these two categories, CMS brought the total number of HACs to ten. (76)

In order to understand the effect that the Never Events policy will have, it is necessary to possess a brief understanding of how CMS reimbursement policy. (77) CMS reimburses hospitals through the Inpatient Prospective Payment System (IPPS IPPS International Parallel Processing Symposium
IPPS International Plant Propagators Society
IPPS Industrial Pollution Projection System
IPPS International Pelvic Pain Society
IPPS Integrated Personnel and Payroll System
IPPS Institute for Public Policy Studies
). (78) IPPS bases payment upon specific, prearranged rates for hospital care. (79) Typically, IPPS does not take into account the length of the hospital stay. (80) When a hospital admits a Medicare-insured patient, the hospital must classify the patient's conditions into a diagnosis-related group diagnosis-related group Managed care A prospective payment system used by Medicare and other insurers to classify illnesses according to diagnosis and treatment; DRGs are used to group all charges for hospital inpatient services into a single 'bundle' for payment  (a classification with pre-arranged reimbursement rates) and report the primary (81) and secondary (82) diagnoses. (83) When the coding for a Never Event appears during hospitalization, CMS will no longer pay the higher rate for treating the condition unless the present-on-admission code is present. (84) If the code is not present, Medicare assumes that the condition was hospital-acquired and refuses to pay for the higher reimbursement rates. (85)

III. THE DIFFERENT STANDARDS OF NEVER EVENTS

As previously indicated, the Never Events concept has evolved over time and so has the list of conditions and events to which that the label applies. (86) Accordingly, as the list changed, so did the standard used by the organization to compile that list. This section will argue that the standard CMS used to compile its list of Never Events was vastly different than the standard used by its predecessors, specifically the NQF. (87)

When NQF adopts a plan, it signifies that the plan has gone through a rigorous vetting process and that its "science ... and its salience sa·li·ence   also sa·li·en·cy
n. pl. sa·li·en·ces also sa·li·en·cies
1. The quality or condition of being salient.

2. A pronounced feature or part; a highlight.

Noun 1.
 in public reporting have been verified...." (88) This vetting process involves collaboration with all areas of the health care industry--including providers, insurers, employers, consumer groups, professional associations, and labor unions. (89) NQF refers to its consensus standards as the "gold standard" for the measurement of health care quality. (90)

The same cannot be said about CMS's vetting process. Whereas NQF strives for consensus among the health care industry, CMS seeks consensus within the Department of Human and Health Services health services Managed care The benefits covered under a health contract  and other federal departments. (91) As a result, NQF chooses conditions that medical professionals could easily prevent; whereas CMS chooses conditions that it could easily categorize and define. (92) Perhaps unsurprisingly, commentators have criticized CMS for its selection process and questioned whether hospitals could actually reduce the occurrence of these events by following CMS's suggestions. (93)

This distinction is significant, as NQF's list of Never Events would ultimately improve hospital care because each event meets two out of three key characteristics. First, that it is completely avoidable; second, that it is the result of a medical mistake--not simply a risk of hospitalization or an illness; and third, that it is avoidable through the adoption of simple, practical guidelines. As this section will demonstrate, by using a different standard to select Never Events, CMS chose events that are not avoidable, that are not the result of a medical mistake, and that do not have sufficient prevention guidelines to assist the hospital in averting the occurrence of an event.

This section begins by examining the standard set by NQF by analyzing two conditions it adopted as Never Events: "Wrong Site Surgery" and "Foreign Object Retained in the Body Following Surgery." Then, this section analyzes two of the CMS Never Events--"Catheter-Associated Urinary Tract Infections," and "Trauma Caused by Falls." Comparing the two standards, this section then contrasts the two standards to demonstrate how CMS's standard departs from that originally set by NQF. (94)

A. Foreign Objects Retained in the Body Following Surgery

Take, for example, "Foreign Objects Retained in the Body Following Surgery", a condition on the original NQF list. (95) Medical professionals accidentally leave a foreign object in a patient's body in one out of every thousand to fifteen hundred intra-abdominal operations. (96) One report suggests that foreign objects are left nearly indiscriminately throughout the body and in every major cavity following surgery. (97) Sponges are the most common objects left in the body following surgery, accounting for seventy percent of these events. (98) Other common objects include towels, instruments and sharps, and device fragments, including pieces of wire or tubes. (99) Further, retention of a foreign object is nine times as likely to occur in an emergency operation and four times as likely to occur when an operation involves an unexpected change in procedure. (100)

This condition demonstrates three important characteristics about the standard that NQF used in selecting a list. First, the event has serious consequences upon the patient. In the present example, leaving a foreign object in the body of a patient has very serious repercussions repercussions nplrépercussions fpl

repercussions nplAuswirkungen pl 
 on that patient's health (101) and may even lead to death. (102) A study in the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world.  examined twenty-four cases where a foreign object was accidentally left in the abdominal cavity following surgery. (103) In the twenty-four observed cases, all the patients suffered from serious complications arising from the retained object re·tained object
n.
An object in a passive construction that is identical to the object in the corresponding active construction, as story in Susan was told the story by John.

Noun 1.
, and two of the patients died as a result of the foreign object. (104) Other common adverse results include readmission to the hospital, additional surgery, infection, and small-bowel obstruction. (105) Financially, the costs of removing a foreign object can be extremely costly--costs can run up to $50,000 per incident. (106)

Second, the event is always the result of a hospital mistake. In other words, a foreign object retained in the body following surgery is "a medical error that should never happen, not a risk that every patient must accept." (107) Of the twenty-four cases, neither the hospital (where the operation occurred) nor the surgeons (who performed the operation) recognized that they had left an instrument inside the patient. (108) Instead, the hospitals discovered the error after the patients reported a wide array of symptoms to their physicians, including non-specified abdominal pain, persistent sinus, intra-abdominal sepsis, and vaginal discharge Vaginal discharge
discharge of secretions from the cervical glands of the vagina; normally clear or white

Mentioned in: Bacterial Vaginosis

vaginal discharge 
. (109)

Third, the event is avoidable. Many commentators consider the retention of sponges and foreign instruments in the body a completely avoidable event. (110) The American College of Surgeons recommends the following guidelines to prevent the retention of objects in the body following surgery: (1) standardized counting procedures for sponges, sharps, instruments; (2) methodical wound exploration exploring wounds before closure; and (3) effective communication among operative team members. (111) A report in the New England Journal of Medicine suggests that by standardizing counting procedures for medical instruments, such as designating team members responsible to methodically explore the wound before closure, hospital staff could greatly reduce any possibility of leaving a foreign object in a body following an operation. (112) Further, the U.S. Food and Drug Administration suggests that if medical professionals were to merely inspect devices prior to and immediately following usage, they would be able to determine whether the instrument was likely to be, or had been, damaged during surgery, a leading cause of retention. (113)

Thus, by analyzing "Foreign Objects Retained in a Body Following Surgery," one can learn a great deal about the high standard set by NQF in its selection of Never Events. Namely, that this event fits three important requirements. First, that the event is completely avoidable; 114 second, the event is always the result of a medical mistake--not the result of hospitalization or an illness; 115 and third, the event is avertable through the adoption of simple, practical guidelines. (116)

B. Wrong-Site Surgery

Similarly, other NQF Never Events exhibit the same high standard. For example, the NQF also vetted "surgery performed on the wrong body part" (or "wrong-site surgery") before selecting it as a Never Event. (117) In so doing, NQF ensured that it selected an event that was completely avoidable; the result of medical mistakes; and avertable through simple guidelines.

A 2006 study by the Archives of Surgery The Archives of Surgery is a monthly professional medical journal published by the American Medical Association. Archives of Surgery publishes original, peer-reviewed clinical and basic research articles addressing new operative techniques, important clinical findings, and , which examined over two million malpractice liability cases in Massachusetts over a twenty-year period, estimated that non-spine wrong-site surgery occurs once in nearly one hundred thirteen thousand operations. (118) If this statistic holds up nationally, it would mean that throughout the country "wrong-site surgery was reported to insurance companies or a lawsuit was filed once every five to ten years at any one hospital." (119)

According to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 the Joint Commission on Accreditation of Healthcare Organizations Joint Commission on Accreditation of Healthcare Organizations,
n.pr the United States body that accredits healthcare organizations.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO/TJC),
n.
 ("JCAHO JCAHO Joint Commission on Accreditation of Healthcare Organizations, see there "), the number of wrong-site surgeries increased during the years 1996 through 2002. (120) Wishing to counteract this trend, JCAHO identified a number of factors that increased the risk of wrong-site surgeries. (121) Increased risk was present when more than one surgeon was involved in the operation, when surgeons performed multiple procedures on a patient during a single operation, when unusual time pressures were involved, when emergencies and operations involved unusual patient characteristics, (122) JCAHO named communication breakdowns as the leading cause of wrong-site surgeries. (123) Put another way, wrong-site surgery is a reflection of "the accuracy and completeness of information brought to the point of care, the quality of professional communication, and the degree of teamwork among the members of the operating team operating team Surgery The participants–surgeons, nurses, etc–in a sterile surgical procedure performed under general–less commonly, local anesthesia ." (124)

As noted, wrong-site surgery is rare, making it difficult to evaluate the effectiveness of guidelines. (125) However, JCAHO refers to certain protocols as baselines upon which all hospitals would be able to build. (126) These protocols are applicable to all settings (127) and include three independent verifications of the surgical site, (128) unequivocally marking the operation site, (129) and ensuring agreement of the procedure with the operating surgeon, anesthesiologist Anesthesiologist
A medical specialist who administers an anesthetic to a patient before he is treated.

Mentioned in: Anesthesia, General, Appendectomy, Parathyroidectomy

anesthesiologist
, and circulating nurses. (130) Confirming this, an article in the Permanente Journal suggests that a simple pre-operation discussion with operation staff could have a significant impact on reducing the occurrence of wrong-site surgeries. (131) Further, the Annals of Surgery study found that hospital staff could have prevented over sixty percent of the incidents by following standard hospital protocol, such as marking the operation site before surgery, using a preoperative pre·op·er·a·tive
adj.
Preceding a surgical operation.



preoperative

preceding an operation.


preoperative care
the preparation of a patient before operation.
 verification process, and resolving uncertainties with staff through proper communication. (132)

As with "Foreign Retention of Objects in the Body Following Surgery," one can learn a great deal about the high standard set by NQF in its selection of Never Events. First, wrong-site surgery is an avoidable event. Second, wrong-site surgery is "a medical error that should never happen, it is not a medical risk that a patient must accept ...." (133) It is often the direct result of negligence by the doctors and staff, or the result of a communication breakdown between members of the operating team. (134) Third, that a hospital could completely avoid wrong-site surgery through the use of simple guidelines. (135) Here, again, NQF chose an event that met the same three key characteristics--the event is avoidable; the result of a medical error; and is avertable through the adoption of simple guidelines.

C. The Standard Set by CMS

As this section will demonstrate, CMS's list of Never Events demonstrates a much lower standard than that applied by the NQF. (136) Accordingly, though CMS asserts that its list of Never Events are reasonably preventable through evidence-based guidelines, some commentators have suggested that CMS abandoned, to a great deal, the consensus that the National Quality Forum (NQF) used as a framework to select the original list of Never Events. (137) Notably, there are serious problems with the evidence-based guidelines that CMS advocates. (138) As discussed in Section II, one of the DRA's requirements was that any HAC HAC Housing Assistance Council
HAC Hill-Start Assist Control (automobiles)
HAC Hearing Aid Compatible
HAC Havre Athletic Club (Le Havre, France)
HAc Acetic Acid
HAC Honourable Artillery Company
 that CMS chose must "reasonably have been prevented through the application of evidence-based guidelines." (139)

This is the case for three reasons. First, CMS often chose conditions that are not preventable. In other words, they are conditions that would occur even with proper medical care. Second, the HACs are often the result of ordinary medical risks and not, as was the case with the NQF list, the result of a medical mistake. Third, CMS advocates that hospitals adopt evidence-based guidelines (to avoid the occurrence of a HAC) that are often vague and inapplicable in·ap·pli·ca·ble  
adj.
Not applicable: rules inapplicable to day students.



in·ap
. As a result, CMS financially punishes a hospital for events that are beyond the hospital's control and for not following unrealistic, inapplicable guidelines. This section illustrates the effect of this change by analyzing two of the events chose by CMS--urinary tract infection and "Injuries Sustained from Falls."

1. Catheter-Associated Urinary Tract Infection (UTI)

At first glance, catheter-associated urinary tract infection (UTI) might seem like a strong candidate to be included as a Never Event--it affects a common necessity of hospitalization--the use of a catheter (140)--and is among the most common infections in acute and long-term care facilities (141)-- affecting between six hundred thousand to one million patients a year. (142) Of the original thirteen conditions it proposed, CMS believed that this condition best met the criteria for an HAC. (143) Further, catheters are among the most widely used devices in hospitals. (144) Moreover, the consequences of a UTI can be devastating, ranging from an additional day of hospital care to death. (145) Additionally, UTIs have a large financial impact--costing the health care system an estimated $400 million annually. (146)

However, CMS there are two main problems here. First, UTI is not an avoidable through proper care of the hospital staff, and second, it is often a medical risk of hospitalization. In fact, CMS admits that most clinicians and infectious disease Infectious disease

A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions.
 control experts do not believe that catheter-associated UTIs are preventable. (147) Many of the contributing factors of UTI are outside the control of the hospital staff. (148) The risk of developing a catheter-associated UTI catheter-associated UTI Catheter-associated urinary tract infectionUrology A UTI linked to use of a catheter–1% to 5% of Pts develop a UTI after a single catheterization, 100% after an indwelling catheter is in place for 4+ days Agents E coli,  depends, in part, upon two several key factors, among them the duration of the catheter once in place, the patient's susceptibility to infection. (149) UTIs are generally considered unavoidable when a catheter is left in the patients for more than four days because of the buildup of bacteria. (150) Thus, patients who require intermediate or long-term use of catheters and/or are confined to a hospital bed have a baseline rate of acquiring a UTI. (151)

Additionally, CMS does not provide simple guidelines that would enable medical professionals to avoid UTIs. CMS instead relies largely upon evidence-based guidelines that were set by a twenty-eight-year-old CDC report. (152) That report asserts prevention guidelines that presume that hospitals could avoid UTIs by properly managing an indwelling catheter indwelling catheter Any catheter, usually understood to be for the urinary bladder–eg, a 'Foley' left in place for a prolonged period of time , (153) by limiting the duration of catheter placements, and by only using catheters when necessary. (154) Proper management, according to that report, includes such actions as catheterizing only when necessary, emphasizing hand washing, and inserting catheter using aseptic aseptic /asep·tic/ (-tik) free from infection or septic material.

a·sep·tic
adj.
Of, relating to, or characterized by asepsis.
 technique and sterile equipment. (155)

CMS reiterated these prevention guidelines in the 2008 Proposed Rule, stating "[t]he primary prevention intervention would be not using catheters or removing catheters as soon as possible...." (156) However, as previously indicated, one of the major risk factors in the development of UTI is the presence of a catheter, which may be necessary to properly care for patients. (157) Despite this, CMS does not make any exception for patients requiring long-term catheter care, for which long-term catheter use is critical to the management of urinary elimination. (158)

For example, consider the Intensive Care Unit, where patients are often immobile and unable to use the restroom. As stated above, in some contexts, the risk of a UTI is unavoidable, even with the use of proper sanitation, if the catheter is used at all. (159) Accordingly, the only way that the hospital could ensure that the patient in the example would not contract a catheter-associated UTI is to not use the device. The hospital thus has two choices: it can leave the patient alone, in increasing pain and discomfort; or administer proper care that necessarily carries with it a risk of infection. Thus, as a result of the Never Events Policy, some hospitals would provide proper treatment (by providing a catheter to a patient in need) and not be reimbursed. (160) Accordingly, one can see a markedly different standard in CMS's adoption of UTI as a "Never Event." A UTI is not avoidable; it is the result of a medical risk; and CMS does not adequately present guidelines to demonstrate how medical professionals could avert UTIs. In other words, whereas NQF chose conditions that were avoidable, the result of hospital mistakes, and avertable through the adoption of simple guidelines; CMS chose a condition that is common, unavoidable and the often, contracted despite proper hospital care.

2. Falls

One can further observe the insufficiency of CMS's standard for selecting Never Events by analyzing its adoption of trauma caused by falls from wheelchairs, chairs, beds, other furniture and commodes as an HAC. (161)

First, the event is not entirely avoidable. As in the case of catheter-associated UTIs, certain patients are much more susceptible to falls--the elderly perhaps most prominently. (162) The incidence of falls and the severity of complications arising from a fall increase with age, increased disability, and functional impairment. (163) For instance, nearly one-third of people sixty-five years of age or older fall at least once per year, (164) at number that rises to fifty percent once people turn eighty years or older. (165) Among the elderly, falls were the second leading cause of death due to unintentional injuries in 1994. (166)

Thus, it may not seem surprising that CMS was more hesitant to include falls as an HAC. (167) In its 2008 Proposed Rule, CMS plainly stated that falls may not be preventable and, as a result, did not initially propose adopting "trauma caused from falls" as an HAC. (168) But it still invited comments on the exclusion of falls as a HAC. (169) Notwithstanding its initial proposal, in its 2008 Final Rule, CMS adopted falls as an HAC. (170) CMS did not provide any compelling reason for its decision, stating generically that falls could be reduced through the application of evidence-based guidelines. (171) CMS simply stated that falls should be reasonably avoidable by hospitals and presented no further support for the idea. (172)

Second, falls are not the result of mistakes that the hospital workers make. While the number of falls can be reduced through the adoption of fall prevention, it is not a medical mistake that should "Never Happen." (173) A 2008 article in the New England Journal of Medicine study compared two hospital staffs: one that adopted risk assessments and strategies for the prevention of falls and one that did not. (174) In the study, the staff that applied the fall-risk prevention strategies reduced the total number of falls by only eleven percent. (175) Put conversely, eighty-nine percent of the falls happened in spite of fall-reduction strategies. (176) In response to the New England Journal of Medicine study, (177) the President of the American Geriatrics Society predicted that no evidence-based intervention could reasonably prevent all falls in elderly patients. (178)

A 1999 article from the Journal of the American Medical Association JAMA: The Journal of the American Medical Association is an international peer-reviewed general medical journal, published 48 times per year by the American Medical Association. JAMA is the most widely circulated medical journal in the world.  seems to confirm these findings, arguing that nationwide fall injuries would not have been reduced through a change of any hospitalization policy, short of favoring outpatient care. (179) In other words, even through the best care available, it may be impossible to completely prevent the elderly from suffering from falls in a hospital setting.

Third, CMS did not provide guidelines that would enable a hospital to avoid the event. Instead, CMS referred to a website that lists all the Patient Safety Indicators (180) as evidence-based guidelines that would help a hospital prevent falls, (181) which does not mention fall reduction. (182) These indicators directly contradict the CMS-given definition that evidence-based guidelines are "best practices for performing certain medical procedures or treatments." (183) Accordingly, any hospital would likely find it difficult to reduce the occurrence of falls through the adoption of these contradictory guidelines.

Thus, one can see that CMS applied a low standard in its adoption of "trauma caused by falls" as a Never Event. Like catheter-associated UTI, CMS chooses an HAC that is unavoidable among certain patients; is not a medical mistake; and CMS does so without providing realistic guidelines on how to prevent or mitigate injuries caused from falls. Again, this standard is in stark contrast to the standard used to create the NQF list--events that are preventable; that result from medical mistakes; and that are avoidable through the adoption of simple guidelines. (184)

3. Further Questions

Further, this Never Events policy raises other complicating issues that CMS never addresses. (185) Though it is intended to reduce costs, this policy could have the opposite effect--and actually increase the cost of care as hospitals spend additional costs on screening and on an undefined appeals process. (186) Other commentators suggest that this policy will force hospitals to engage in cost shifting and thus, will not reduce costs at all. (187) Instead of facing a financial punishment, hospitals will simply allocate unpaid costs of care from one patient through above-cost charges to other patient populations. (188)

Additionally, hospitals will be forced to increase its resources towards screening. As previous indicated, CMS's policy is based upon the IPPS reimbursement billing system. (189) If the present-on-admission code is not present, CMS presumes that the condition was hospital-acquired and will not reimburse the hospital. (190) As a result, a hospital must ensure that it detects all preexisting conditions. (191) As previously indicated, a hospital must screen an entering patient through the use of a doctor or a trained technician in order to receive reimbursement for treating a Never Event. (192)

However, hospitals may be violating the law if they attempt to screen in an emergency. The Emergency Medical Treatment and Active Labor Act The Emergency Medical Treatment and Active Labor Act (, EMTALA) is a United States Act of Congress passed in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act.  (EMTALA EMTALA Emergency Medical Treatment & Active Labor Act, see there ) forbids a hospital from delaying medical examination and treatment in the emergency department in order to obtain insurance informationj93 or prior authorization prior authorization,
n See predetermination.

prior authorization Health insurance A cost containment measure that provides full payment of health benefits only if the hospitalization or medical treatment has been
 for care. (194) This may present a unique challenge with regard to Never Events, where the screening is necessary to receive reimbursement--and thus an attempt to receive authorization for care. (195) As a result, a hospital may not be able to thoroughly detect for the presence of some Never Events for patients that it admits for care. (196)

Consider an example where a man enters the emergency room complaining of chest pains. The physician quickly determines that the man is suffering from a heart attack and in need of emergency care. The man also exhibits many of the individual characteristics that make him more likely to be suffering from an early-stage pressure ulcer--a Never Event that is particularly hard to detect in early stages. (197) The physician is between a rock and a hard place. On one hand, she knows that if she does not thoroughly screen the man for a pressure ulcer Pressure ulcer
Also known as a decubitus ulcer, pressure ulcers are open wounds that form whenever prolonged pressure is applied to skin covering bony outcrops of the body. Patients who are bedridden are at risk of developing pressure ulcers.
, the hospital will not have the proper present-on-admission codes that it needs to receive reimbursement. (198) On the other hand, the patient is in need of emergency care for his heart, and further, the physician cannot delay treatment or else risk a violation of EMTALA for delaying treatment in order to obtain a form of "prior authorization for care." (199)

The hospital's only line of defense would be to appeal. However, it is not clear that a hospital would even have the right to appeal a Never Event ruling, or how it would do so. CMS declined to specify any appeals process, only stating that current procedures allow providers to challenge denials of reimbursement. (200) Accordingly, any hospitals that decide to appeal a denial in reimbursement may find themselves in a lengthy, undefined appeals process--a cost that could ultimately be passed on to its patients.

IV. RECOMMENDATIONS

This Section makes three recommendations. First, it suggests that CMS should revise the standard it uses when selecting future Never Events. Primarily, it should adopt a standard that is similar to the one used by the NQF. Second, this Section suggests that CMS should revise its current list of Never Events to those events that the NQF vetted. Doing so would reduce the number of HACs from ten to three and ensure that hospitals would have proper guidelines to avoid a Never Event. Third, CMS needs to change how it selects future Never Events.

First, CMS should revise the standard it uses when it selects future Never Events. As previously indicated, CMS's standard has inherent problems. (201) Accordingly, a hospital may find itself being denied reimbursement for a patient's unavoidable injuries caused by a non-preventable condition and without guidance from CMS on how the hospital could improve in the care.

Instead, CMS should reevaluate how it selects future events to be included in the list. CMS should account for three factors: (1) the ability of the hospital to completely avoid the event; (2) the existence of true industry-wide evidence-based guidelines; and (3) the effect that event has upon the patient's life. For example, had CMS used this standard in selecting its original list, it would have selected "foreign object retained in the body following surgery" as a Never Event and not a "Catheter-Associated U.T.I." By adopting this standard, CMS would only choose events that were both truly avoidable and largely disabling to patients.

Second, CMS should limit its current list of Never Events to completely preventable medical errors that have been vetted through a NQF-like collaboration process. (202) In doing so, CMS should distinguish between those events that are truly preventable (or medical m/stakes) and those that are complications of illness or hospital stays (or medical risks). (203) Coincidentally, of the ten categories of HACs, the only events that are always preventable are all found on the NQF's list of Never Events. Practically speaking, this change would mean reducing the number of Never Events to three: leaving foreign objects in the body during surgery; failing to prevent air embolisms following surgery; and providing incompatible blood or blood products during care. (204)

CMS could better serve hospitals by adopting guidelines that accurately reflect the practices used in the medical profession. (205) If CMS chooses to do this, it needs to carefully select guidelines that will enable hospitals, physicians, and medical care workers to completely avoid the Never Events. To facilitate this, CMS should follow the example set by the NQF, and seek a consensus from physicians, hospitals, and other healthcare providers, including "public and private purchasers; national, regional, state, and local groups representing consumers; accrediting bodies; supporting industries; and organizations involved in healthcare research or quality improvement." (206)

CONCLUSION

In conclusion, Never Events policies represent an effort to reduce costs and medical errors, but ultimately raise many unanswered questions, as this Note has attempted to demonstrate. (207) Although many groups have used the term "Never Events," the standard by which the events are selected has changed considerably over time. Whereas policy groups once used the term to mark the distinction between acceptable and unacceptable levels of hospital care, it has evolved into a government policy that punishes the occurrence of unavoidable events. In other words, while Never Events once referred to "events that should never happen," it now refers to events that are unavoidable hospital risks without guidance on how to improve in the future. Put simply, Never Events are now events that sometimes happen and cannot be avoided.

Further, a number of questions remain unanswered. For example, what ability does the hospital have to appeal a Never Event determination? How should a patient's unique characteristics affect a Never Events determination? (For example, the patient's age, mobility, etc.). How should a hospital improve its care in the future, so as to avoid a similar determination in the absence of appropriate evidence-based guidelines? Finally, how will EMTALA interact with physician's requirement to screen all patients on admission for a Never Event?

Ultimately, hospitals and patients will have to determine the answers to these questions. They will likely do so by paving the way through a costly appeals process and incurring a difficult financial burden that may ultimately increase, instead of reduce, costs. Accordingly, CMS should rethink this policy, and change the standard it uses in selecting Never Events. Until CMS does so, hospitals will likely find Never Events policies confusing, vague, difficult to implement, and ultimately, unhelpful to patient care.

(1) Betsy McCaughey, Hospital Infections: Preventable and Unacceptable, WALL ST. J., Aug. 14, 2008, at A11.

(2) Id.

(3) Id.

(4) Id.

(5) This Note generally differentiates medical risks' from medical errors, or mistakes. For purposes of this Note, a medical risk is the chance that the patient will suffer from a known, yet unintended, consequence of care that exists despite proper care of the doctors and/or staff. An example of a medical risk is the risk of an infection. In contrast, a medical mistake is a serious breach of proper care. An example of a medical mistake is an operation on the wrong limb.

(6) There is no universally accepted definition of what a medical error is. However, Albert W. Wu, et al. provide a helpful definition. They define a medical mistake as "[a] commission or an omission with potentially negative consequences for the patient that would have been judged wrong by skilled and knowledgeable peers at the time it occurred, independent of whether there were any negative consequences." Albert W. Wu et al., To Tell The Truth: Ethical and Practical Issues in Disclosing Medical Mistakes to Patients, 12 J. BEN. INTERNAL MED. 770, 770 (1997). Though Wu uses the term "mistake" instead of "error," the two are oftentimes used interchangeably. See, e.g., Richard T. Penson et al., Medical Mistakes. A Workshop on Personal Perspectives, 60NCOLOGIST 92, 94 (2001).

(7) See William M. Sage, Pay for Performance: Will it Work in Theory?, 3 IND. HEALTH L. REV. 305, 310 (2006).

(8) See Robin J. Fisk Fisk   , James 1834-1872.

American railroad financier and speculator who attempted in 1869 to corner the gold market with Jay Gould, leading to Black Friday, a day of nationwide financial panic.
, What Are Never Events and Why Do They Matter?, Nov. 6, 2008, http://www.passionforsubro.com/never-events/ what-are-never-events-and-why-do-they-matter/; see also CTRS CTRS Centers (street suffix)
CTRS Containers
CTRS Certified Therapeutic Recreation Specialist
CTRS Conventional Terrestrial Reference System
CTRS Center for Technology Risk Studies (University of Maryland) 
. FOR MEDICARE & MEDICAID SERVS SERVS Ship Escort Response Vessel System (Alyeska Pipeline Service Company) ., ELIMINATING SERIOUS, PREVENTABLE, AND COSTLY MEDICAL ERRORS--NEVER EVENTS (2006), http://www.cms.hhs.gov/apps/media/press/release .asp?Counter=1863.

(9) Sage, supra A relational DBMS from Cincom Systems, Inc., Cincinnati, OH (www.cincom.com) that runs on IBM mainframes and VAXs. It includes a query language and a program that automates the database design process.  note 7, at 310.

(10) Pay for Performance is perhaps best described by William M. Sage as a system that "[rewards] physicians for health rather than illness." Id. at 307.

(11) See id

(12) Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. 47,130, 47,218 (Aug. 22, 2007) (to be codified cod·i·fy  
tr.v. cod·i·fied, cod·i·fy·ing, cod·i·fies
1. To reduce to a code: codify laws.

2. To arrange or systematize.
 at 42 CFR CFR

See: Cost and Freight
 pts. 411,412, 413, 489).

(13) Bureau of Nat'l Affairs, CMS Cuts Number of 'Never Events" For Which it Won't Pay, Issues Other Rules, 17 BNA's HEALTH L. REP. 1069 (2008).

(14) McCaughey, supra note 1.

(15) See generally Fisk, supra note 8.

(16) Id.

(17) Hence, by refusing to reimburse the hospitals for the costs of care associated with these events, insurers create an incentive for doctors to invest in preventative measures that could presumably pre·sum·a·ble  
adj.
That can be presumed or taken for granted; reasonable as a supposition: presumable causes of the disaster.
 reduce hospitals errors. See id.

(18) E.g., Rachel Deutsch, The Federal Role in Reducing Hospital-Acquired Conditions: Are Medicare Reimbursement Incentives Enough? 42 COLUM. J.L. & SOC. PROBS. 1 (2008); see also Sheryl Tatar Tatar
 or Tartar

Any member of the Turkic-speaking peoples who today live mainly in west-central Russia east to the Ural Mountains, in Kazakhstan, and in western Siberia. They first appeared as nomadic tribes in northeastern Mongolia in the 5th century.
 Dasco et al., The "'Never Events ": What It Means For Physicians, 10 J. HEALTH CARE COMPLIANCE 33, 33 (2008).

(19) Dasco et al., supra note 18, at 34.

(20) Id.

(21) Id.

(22) Id. at 35.

(23) CTR See click-through rate. . FOR MEDICARE ADVOCACY, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic.

Antonym: dec.
., CMS TO HOSPITALS: IF IT SHOULD NEVER HAPPEN, WE WILL NEVER PAY, http://www.medicareadvocacy.org/ InfoByTopic/Reform/Reform 08 09.25.NeverEvents.htm (last visited May 3, 2010).

(24) For an explanation of primary and principal diagnoses, see generally, JOANN C. ROWELL & MICHELLE MICHELLE Mid-Infrared Echelle Spectrograph  A. GREEN, UNDERSTANDING HEALTH INSURANCE: A GUIDE TO PROFESSIONAL BILLING 123 (7th ed. 2004).

(25) This is so because a patient could develop a non-apparent condition before her admittance Admittance

The ratio of the current to the voltage in an alternating-current circuit. In terms of complex current I and voltage V, the admittance of a circuit is given by Eq. (1), and is related to the impedance of the circuit Z by Eq. (2).
 to a hospital and unless the condition is detected by the hospital during admission her condition could be labeled as a "Never Event." For example, a stage-one pressure ulcer is difficult to detect, especially in individuals with dark skin tones. WOUND OSTOMY ostomy

Surgical opening in the body, or the operation creating it, usually to allow discharge of wastes through the abdominal wall. It may be temporary, to relieve strain on damaged organs, or permanent, to replace normal channels congenitally missing or surgically removed
 & CONTINENCE continence /con·ti·nence/ (kon´tin-ens) the ability to control natural impulses.con´tinent

con·ti·nence
n.
1. Self-restraint; moderation.

2.
 NURSES SOC'Y, POSITION STATEMENT: PRESSURE ULCER STAGING (2007), http://www.wocn.org/pdfs/WOCN_Library/Position _Statements/PressureUlcerStaging.pdf.

(26) See Fisk, supra note 8.

(27) See Linda Wilson, POA Coding Challenges: Concern Grows" Over Quality of Documentation, MODERN HEALTHCARE, June 2, 2008, at 10.

(28) NAT'L QUALITY FORUM, SERIOUS REPORTABLE EVENTS IN HEALTHCARE 2006 UPDATE: A CONSENSUS REPORT (2007), http://www.qualityforum.org/ Publications/2007/03/Serious_Reportable_Events_in_Healthcare%E2%80%932006 Update.aspx [hereinafter NAT'L QUALITY FORUM 2006].

(29) These Hospital Acquired Conditions are: (1) foreign object retained after surgery; (2) air embolism air embolism: see embolus. ; (3) blood incompatibility; (4) stage III and IV pressure ulcers; (5) falls and traumas (fractures, dislocations, intracranial intracranial /in·tra·cra·ni·al/ (-kra´ne-al) within the cranium.

in·tra·cra·ni·al
adj.
Within the cranium.
 injuries, crushing injuries, burns and electric shock); (6) manifestations of poor glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


glycemic

pertaining to the level of glucose in the blood.
 control (diabetic ketoacidosis Diabetic Ketoacidosis Definition

Diabetic ketoacidosis is a dangerous complication of diabetes mellitus in which the chemical balance of the body becomes far too acidic.
, nonketotic hyperosmolar coma Nonketotic hyperosmolar coma (nonketotic hyperglycaemia) is a type of diabetic coma associated with a high mortality seen in diabetes mellitus type 2. The preferred term used by the American Diabetes Association is hyperosmolar nonketotic state (HNS). , hypoglycemic hypoglycemic /hy·po·gly·ce·mic/ (-gli-sem´ik)
1. pertaining to, characterized by, or causing hypoglycemia.

2. an agent that lowers blood glucose levels.
 coma, secondary diabetes with ketoacidosis, secondary diabetes with hyperosmolarity); (7) catheter associated urinary tract infection; (8) vascular catheter-associated infection; (9) surgical site infection following: coronary artery bypass Coronary artery bypass
Surgical procedure to reroute blood around a blocked coronary artery.

Mentioned in: Heart Failure

coronary artery bypass,
n
 gaft, bariatric surgery Bariatric Surgery Definition

Bariatric surgery promotes weight loss by changing the digestive system's anatomy, limiting the amount of food that can be eaten and digested.
 (laparoscopic gastric bypass gastric bypass
n.
A surgical procedure used for treatment of morbid obesity, consisting of the severance of the upper stomach, anastomosis of the small upper pouch of the stomach to the jejunum, and closure of the distal part of the stomach.
, gastroenterostomy, laparoscopic gastric restrictive surgery), orthopedic procedures (spine, neck, shoulder, elbow); and (10) deep vein thrombosis. Fisk, supra note 8.

(30) INST. OF MED., TO ERR IS HUMAN: BUILDING A SAFER HEALTH SYSTEM (Linda T. Kohn et al. eds., 2000), available at http://orsted.nap.edu/openbook/ 0309068371/html/.

(31) Id. at 1.

(32) Id.; see also Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates, 73 Fed. Reg. 48,434, 48,471 (Aug. 19, 2008) (to be codified at 42 C.F.R. pts. 411, 412, 413, 422, 489).

(33) INST. OF MED., supra note 30, at 1.

(34) Id. at 2.

(35) Nat'l Inst. of Child Health & Human Dev., Nat'l Inst. of Health, Story of Discovery: The First Vaccine Against Hospital-Acquired Infection, Sept. 1, 2006, http://www.nichd.nih.gov/news/resources/discovery/2004/staph.cfm.

(36) Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates, 73 Fed. Reg. at 48,471.

(37) See BETSY McCAUGHEY, UNNECESSARY DEATHS: THE HUMAN AND FINANCIAL COSTS OF HOSPITAL INFECTIONS 1 (2nd ed. 2006) (summarizing efforts taken by Denmark, Holland, and Finland that have successfully reduced hospital infections).

(38) The four common infections are aspiration and ventilator associated pneumonia, central venous catheter central venous catheter
n.
A catheter passed through a peripheral vein and ending in the thoracic vena cava; it is used to measure venous pressure or to infuse concentrated solutions.
 related bloodstream infection, surgical site infection, and influenza (staff vaccination against the flu). Press Release, Leapfrog Group, Eighty-Seven Percent of Hospitals Do Not Take Recommended Steps to Prevent Infections (Sept. 10, 2007), http://www.leapfroggroup.org/media/file/Leapfrog _hospital_acquired_infections_release.pdf.

(39) E.g., H.T. Stelfox et al., The "To Err is Human" Report and the Patient Safety Literature, QUALITY & SAFETY HEALTH CARE, Apr. 2006, at 174 (2006); see also Stephen M. Sullivan et al., Ensuring "Never Events" Never Happen. CMS Halts Reimbursement to Providers for Certain Conditions, 23 DENNIS BARRY'S REIMBURSEMENT ADVISOR 3, 3 (2007).

(40) See, e.g., Randall R. Bovbjerg & Laurence R. Tancredi, Liability Reform Should Make Patients Safer: "'Avoidable Classes of Events" Are a Key Improvement, 33 J.L. MED. & ETHICS 478 (2005) (arguing that Never Events claims should be paid promptly through an insurance process rather than through adjudication The legal process of resolving a dispute. The formal giving or pronouncing of a judgment or decree in a court proceeding; also the judgment or decision given. The entry of a decree by a court in respect to the parties in a case. ).

(41) NQF is a not-for-profit membership group, established to develop and implement a national strategy for health care quality measurement and reporting. NQF endorses quality measures for national use through the use of evidence-based quality information to develop preferred practices for all types of settings. JOINT COMM'N RES., TOOLS FOR PERFORMANCE MEASUREMENT HEALTH CARE: A QUICK REFERENCE GUIDE 14 (2nd ed. 2008).

(42) NAT'L QUALITY FORUM, SERIOUS REPORTABLE EVENTS IN HEALTHCARE: A CONSENSUS REPORT (2002), http://www.qualityforum.org/Publications/2002/Serious _Reportable_Events in Healthcare.aspx [hereinafter NAT'L QUALITY FORUM 2002].

(43) The 27 events are: unintended retention of a foreign object in a patient after surgery or other procedure; patient death or serious disability associated with patient elopement Elopement
Carker, James

with Dombey’s wife. [Br. Lit.: Dombey and Son]

Leonora

with Alvaro, rejected as suitor by her father. [Ital.
 (disappearance); patient death or serious disability associated with a medication error medication error Malpractice An error in the type of medication administered or dosage. See Adverse effect, Error.  (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration); patient death or serious disability associated with a hemolytic he·mo·lyt·ic
adj.
Destructive to red blood cells; hematolytic.


Hemolytic
Referring to the destruction of the cell membranes of red blood cells, resulting in the release of hemoglobin from the damaged cell.
 reaction due to the administration of ABO/HLA-incompatible blood or blood products; patient death or serious disability associated with an electric shock or elective cardioversion Cardioversion Definition

Cardioversion refers to the process of restoring the heart's normal rhythm by applying a controlled electric shock to the exterior of the chest.
 while being cared for in a healthcare facility; patient death or serious disability associated with a fall while being cared for in a healthcare facility; surgery performed on the wrong body part; surgery performed on the wrong patient; wrong surgical procedure performed on a patient; intraoperative or immediately post-operative death in an ASA Asa (ā`sə), in the Bible, king of Judah, son and successor of Abijah. He was a good king, zealous in his extirpation of idols. When Baasha of Israel took Ramah (a few miles N of Jerusalem), Asa bought the help of Benhadad of Damascus and  Class 1 patient; patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility; patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended; patient death or serious disability associated with intravascular intravascular /in·tra·vas·cu·lar/ (in?trah-vas´ku-lar) within a vessel.

in·tra·vas·cu·lar
adj.
Within one or more blood vessels.
 air embolism that occurs while being cared for in a healthcare facility; infant discharged to the wrong person; patient suicide, or attempted suicide resulting in serious disability, while being cared for in a healthcare facility; maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility; patient death or serious disability associated with hypoglycemia hypoglycemia: see diabetes.
hypoglycemia

Below-normal levels of blood glucose, quickly reversed by administration of oral or intravenous glucose. Even brief episodes can produce severe brain dysfunction.
, the onset of which occurs while the patient is being cared for in a healthcare facility; death or serious disability (kemicterus) associated with failure to identify and treat hyperbilirubinemia in neonates; stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility; patient death or serious disability due to spinal manipulative therapy Spinal manipulative therapy (SMT) is the generic term commonly given to a group of manually applied therapeutic interventions. [1] These interventions are usually applied with the aim of inducing intervertebral movement by directing forces to vertebrae, and include spinal ; any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substance; patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility; patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility; any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider; abduction of a patient of any age; sexual assault on a patient within or on the grounds of the healthcare facility; and death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the healthcare facility. See id. at 6-7.

(44) NAT'L QUALITY FORUM 2006, supra note 28, at 14.

(45) The categories are: surgical, product of device, patient protection, care management, environment, or criminal. NAT'L QUALITY FORUM, SERIOUS REPORTABLE EVENTS (SREs): TRANSPARENCY & ACCOUNTABILITY ARE CRITICAL TO REDUCING MEDICAL ERRORS, http://www.lumetrasolutions.com/uploadedFiles/ consulting/about-lumetra/enewsletters/lqi/about-lumetra/NQF_NeverEvents Factsheet%281%29.pdf (last visited May 3, 2010) [hereinafter NAT'L QUALITY FORUM SRE SRE Secretaría de Relaciones Exteriores (México)
SRE Sex and Relationship Education
SRE Serum Response Element (biochemistry)
SRE Software Reliability Engineering
SRe Seychelles Rupee
].

(46) Id.

(47) See NAT'L QUALITY FORUM 2006, supra note 28, at 2.

(48) See NAT'L QUALITY FORUM SRE, supra note 45.

(49) LEAP FROG GROUP, FACTSHEET: NEVER EVENTS (2008).

(50) Press Release, The Nat'l Quality Forum, National Quality Forum Updates Endorsement of Serious Reportable Events in Healthcare 1 (Oct. 16, 2006), http://s.wsj.net/public/resources/documents/WSJ_PRSeriousReportableEvents 10-15-06.pdf.

(51) Id.

(52) Leapfrog Group for Patient Safety is an advocacy group that represents many of the nation's largest corporations and purchasers of health benefits with a stated goal of "mobilizing employer purchasing power Purchasing Power

1. The value of a currency expressed in terms of the amount of goods or services that one unit of money can buy. Purchasing power is important because, all else being equal, inflation decreases the amount of goods or services you'd be able to purchase.

2.
 to alert America's health industry that big leaps in health care safety, quality and customer value will be recognized and rewarded." Leapfrog Group, About Us, http://www.leapfroggroup.org/ about_us (last visited May 3, 2010).

(53) Leapfrog Group, Leapfrog Group Position Statement on Never Events, http://www.leapfroggroup.org/for_hospitals/ leapfrog_hospital_quality_and_safety survey copy/never events (last visited May 3, 2010).

(54) Id.

(55) Id.

(56) MINNESOTA DEP'T OF HEALTH, ADVERSE HEALTH EVENTS IN MINNESOTA: 5TH ANNUAL PUBLIC REPORT 1 (2009), http://www.health.state.mn.us/ patientsafety/ae/09ahereport.pdf.

(57) Press Release, Nat'l Bus. Coal. on Health, National Business Coalition on Health Endorses New CMS 'Never Events' Policy (Sept. 29, 2008), http://nbch.org/ index.asp?bid=78.

(58) Fisk, supra note 8.

(59) JoNel Aleccia, More States' Shred Bills for Awful Medical Errors', MSNBC.com, Aug. 12, 2008, http://www.msnbc MSNBC Microsoft/National Broadcasting Company .msn.com/id/26081421.

(60) Cigna denies complete reimbursement for serious preventable errors and grants only partial reimbursement for "avoidable hospital conditions." Cigna defines serious preventable errors as "surgical procedures that are performed on the wrong side, wrong site, wrong body part or wrong person." Cigna defines avoidable hospital conditions as: "objects left inside a patient during surgery; air embolism, or sudden artery blockage from air bubbles introduced during surgery; use of the wrong blood type during transfusions; infections from urinary catheters; pressure ulcers, also known as bed sores; infections from central vein catheters; mediastinitis, an often fatal inflammation in lung tissue; and hospital-acquired injuries, such as fractures, dislocations, and bums." CIGNA HEALTHCARE, PROMOTING PATIENT SAFETY: CIGNA TO STOP REIMBURSING HOSPITALS FOR NEVER EVENTS AND AVOIDABLE HOSPITAL CONDITIONS (2008), http://newsroom.cigna.com/article_display.cfm? article_id=888.

(61) Fisk, supra note 8.

(62) The Deficit Reduction Act of 2005, codified at 42 U.S.C. [section] 1395ww(d)(4)(D)(iv) (2007).

(63) Id.

(64) [section] 1395 ww(d)(4)(D)(iv)(I-II) (2006). In explaining "evidence-based guidelines," CMS stated: "[s]elected conditions must be considered reasonably preventable through the application of evidence-based guidelines. By reviewing guidelines from professional organizations, academic institutions, and entities ... we evaluated whether guidelines are available that hospitals should follow to prevent the condition from occurring in the hospital." Thus, evidence-based guidelines might be described as any guidelines that would help a hospital avoid these events. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates, 73 Fed. Reg. 23,527, 23,549 (Apr. 30, 2008) (to be codified at 42 C.F.R. pts. 41 l, 412, 413 et al.). A guideline is evidence-based if it is based on clinical research. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates, 73 Fed. Reg. 48,434, 48,474 (Aug. 19, 2008) (to be codified at 42 C.F.R. pts. 411, 412, 413, 422, 489). CMS did not further define the reasonably preventable standard or list any criteria that would make a condition reasonably preventable. CMS simply stated that the DRA "does not require that a condition be 'always preventable' in order to qualify as an HAC" and that reasonably preventable "... implies something less than 100%." Id.

(65) Medicare Program; Proposed Changes to the Hospital Inpatient Prospec tive Payment Systems and Fiscal Year 2008 Rates, 72 Fed. Reg. 24,679, 24,716 (proposed May 3, 2007) (to be codified at 42 C.F.R. pts. 411,412, 413, 489). For an explanation of diagnosis-related groups and the IPPS reimbursement, see generally id. at 24,716-24,718.

(66) Id.

(67) Id. at 24,718.

(68) Although NQF also lists "Stage 3 or 4 Pressure Ulcers" as a Never Event, CMS confusingly does not list Pressure Ulcers as an SPE SPE - Software Practice and Experience . See NAT'L QUALITY FORUM 2006, supra note 28, at 14.

(69) See Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. 47,130, 47,218 (Aug. 22, 2007) (to be codified at 42 CFR pts. 41 l, 412,413,489).

(70) Catheter-Associated UTI is the most common type of healthcare-related infection. CTR. FOR DISEASE CONTROL & PREVENTION, AN OVERVIEW OF CATHETERASSOCIATED URINARY TRACT INFECTIONS (UTI) (2009), http://www.cdc.gov/ncidod/ dhqp/dpac_uti.html.

(71) A pressure ulcer is a wound in the skin that can be caused by pressure from sitting or lying in one place too long. NAT'L HEALTH QUALITY CAMPAIGN, PRESSURE ULCER FACT SHEET (2008), http://www.nhqualitycampaign.org/files/ factsheets/Staff%20Fact%20Sheet%20-%20Reducing%20Pressure%20Ulcers.pdf.

(72) Air embolisms result from gas bubbles entering the arteries, veins or capillaries. This results in poor oxygen delivery to the areas supplied by the affected circulation and can lead to death. Undersea & Hyperbaric hyperbaric /hy·per·bar·ic/ (-bar´ik) having greater than normal pressure or weight; said of gases under greater than atmospheric pressure, or of a solution of greater specific gravity than another used as a reference standard.  Med. Soc'y, Air or Gas Embolism Gas Embolism Definition

Gas embolism, also called air embolism, is the presence of gas bubbles in the bloodstream that obstruct circulation.
Description
, http://www.uhms.org/ResourceLibrary/Indications/AirorGasEmbolism/ tabid/271/Default.aspx (last visited May 3, 2010).

(73) Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. at 47,217-47,218. In addition, the following were considered but not chosen: (1) ventilator-associated pneumonia; (2) staphylococcus aureus Staphylococcus au·re·us
n.
A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning.


Staphylococcus aureus Staphylococcus pyogenes
 septicemia septicemia (sĕptĭsē`mēə), invasion of the bloodstream by virulent bacteria that multiply and discharge their toxic products. The disorder, which is serious and sometimes fatal, is commonly known as blood poisoning. ; (3) deep vein thrombosis/pulmonary embolism; (4) methicillin-resistant staphylococcus aureus methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline, ; (5) clostridium difficile Clostridium difficile A common cause of bacterial colitis; it is the causative agent in 99% of pseudomembranous colitis, and 20-30% of antibiotic-associated diarrhea ; and (6) wrong surgery. Id.

(74) Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates, 73 Fed. Reg. 48,434, 48,475 48,489 48,481. (Aug. 19, 2008) (to be codified at 42 C.F.R. pts. 411, 412, 413, 422, 489).

(75) Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates, 73 Fed. Reg. at 48,477 48,478 48,479. CMS proposed nine conditions originally, but ended up only selecting two. The nine conditions it proposed are: (1) surgical site infections following certain elective procedures; (2) Legionnaires' Disease; (3) extreme blood sugar derangement de·range·ment
n.
1. Disturbance of the regular order or arrangement of parts in a system.

2. Mental disorder; insanity.



de·range
; (4) collapse of the lung resulting from medical treatment; (5) delirium delirium

Condition of disorientation, confused thinking, and rapid alternation between mental states. The patient is restless, cannot concentrate, and undergoes emotional changes (e.g., anxiety, apathy, euphoria), sometimes with hallucinations.
; (6) ventilator-associated pneumonia; (7) deep vein thrombosis/pulmonary embolism; (8) staph infection in the bloodstream; and (9) Clostridium clostridium

Any of the rod-shaped, usually gram-positive bacteria (see gram stain) that make up the genus Clostridium. They are found in soil, water, and the intestinal tracts of humans and other animals. Some species grow only in the complete absence of oxygen.
 Difficile-Associated Disease ("CDAD CDAD Clostridium Difficile-Associated Diarrhea
CDAD Component Data Administrator
"). Id. at 48,433-49,083.

(76) Sage, supra note 7, at 307; see also CTRS. FOR MEDICARE & MEDICAID SERVS., HOSPITAL-ACQUIRED CONDITIONS, http://www.cms.hhs.gov/HospitalAcq Cond/06Hospital-AcquiredConditions.asp (last visited May 3, 2010).

(77) See generally CTRS. FOR MEDICARE & MEDICAID SERVS., ACUTE INPATIENT PPS (Packets Per Second) The measurement of activity in a local area network (LAN). In LANs such as Ethernet, Token Ring and FDDI, as well as the Internet, data is broken up and transmitted in packets (frames), each with a source and destination address. : OVERVIEW (2009), http://www.cms.hhs.gov/acuteinpatientpps/(describing the payment system for operating costs of acute care hospital impatient stays under Medicare based on prospectively set rates).

(78) Id.

(79) Fisk, supra note 8; Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates, 72 Fed. Reg. 24679 (May 3, 2007).

(80) Id.

(81) A "primary diagnosis is the most significant condition for which services and/or procedures were provided." ROWELL & GREEN, supra note 24, at 123.

(82) A secondary diagnosis encompasses any concurrent condition that coexists with the primary diagnosis and includes complications usually conditions that develop subsequent to inpatient admission. Id.

(83) See Dave Carpenter, "Never' Land, HOSP HOSP Hospital
HOSP House Sparrow
HOSP Hot Springs National Park (US National Park Service) 
. & HEALTH NETWORKS, Nov. 2007, at 34, 37-38.

(84) Fisk, supra note 8.

(85) Id.

(86) Cf NAT'L QUALITY FORUM 2002, supra note 42, with Fisk, supra note 8.

(87) Id.

(88) Jean DerGurahian, New Rules Drawing Fire: Hospitals Say CMS' New Policies Lack Direction, 38 MOD. HEALTHCARE 8, 8 (2008).

(89) JOINT COMM'N RES., supra note 50.

(90) Press Release, Nat'l Quality Forum, National Quality Forum Endorses Consensus Standards for Quality of Hospital Care (May 15, 2008), http://www.quality forum.org/News_And_Resources/Press_Releases/2008/ NATIONAL_QUALITY_FORUM_ENDORSES_CONSENSUS_STANDARDS _FOR_QUALITY OF HOSPITAL_CARE.aspx.

(91) CTRS. FOR MEDICARE & MEDICAID SERVS., THE RULE MAKING PROCESS FOR ADMINISTRATIVE SIMPLIFICATION: WHAT IS TAKING SO LONG?, http://www.cms .hhs.gov/H1PAAGenInfo/Downloads/RuleMakingProcess.pdf (last visited May 3, 2010).

(92) See DerGurahian, supra note 88.

(93) See id.

(94) Some commentators have expressed concerns that the Never Events policy could affect medical malpractice suits. See Charles D. Brown et al., Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 Impact of Never Events, HEALTH LAW. NEWS, Feb. 2008, at 27, available at http://www.fulbright.com/images/publications/Never%20Events%20Article-pdf. Never Events would likely only aid plaintiffs as a means of discrediting an expert witness or in support for the argument that the Never Events extend an already-existing inference of negligence.

First, Never Events could serve to discredit an expert witness. Id. Consider a scenario in which an elderly woman, recovering from hip displacement, voluntarily leaves her hospital bed and falls, even though the hospital staff implemented all proper fall precautions. Id. at 27.

As a result of the fall, the elderly woman suffers painful and costly injuries and sues the hospital for negligence. Id. The hospital would rely on an expert witness to argue that the staff did not act unreasonably. The plaintiff could pose the following line of questioning Noun 1. line of questioning - an ordering of questions so as to develop a particular argument
line of inquiry

line of reasoning, logical argument, argumentation, argument, line - a course of reasoning aimed at demonstrating a truth or falsehood; the
:

Ms. Expert, you have testified that you believe that falls can occur even where no negligence has occurred? You believe that not all falls are preventable? Are you aware that CMS has studied this precise issue? Id. at 28. Facing this line of questioning, the expert witness has two choices. Id. She could admit that she is aware that CMS determined that falls are reasonably preventable through the application of evidence-based guidelines; or admit that she is unaware of CMS's reimbursement policy which could make her look "unqualified, incompetent, and uninformed." Id.

Secondly, a plaintiff might argue that Never Events create a rebuttable Re`but´ta`ble   

a. 1. Capable of being rebutted.
 inference of negligence. Several states adopt a rebuttable inference of negligence for two Never Events when a foreign object was unintentionally left within the body of the patient following surgery; and when a surgical procedure was performed on the wrong patient, wrong limb or part of the patient's body. Lisa Frye Garrison, Addressing the Potential Litigation Impacts of CMS's "Never Events" Rules, http://www .healthcarelawnote.com/media/20080516handout.pdf (last visited May 3, 2010). A plaintiff could attempt to extend a similar rebuttable inference of negligence to all of the Never Events- and argue that CMS's refusal to reimburse a hospital implies a liability determination.

As a solution, states might consider the implementation of legislation that excludes the use of Never Events determinations as evidence of negligence of the hospital staff. A strong precedent for this is set by the so-called "apology laws." See Marlynn Wei, Doctors, Apologies and the Law. An Analysis and Critique of Apology Laws, 39 J. HEALTH L. 104 (2006). These laws exclude apologies from court as evidence of a doctor's liability. Id. In other words, as a result of these laws, a doctor can apologize for mistakes to his patient without legal liability implications. MAXWELL J. MEHLMAN & DALE A. NANCE, MEDICAL. INJUSTICE: THE CASE AGAINST HEALTH COURTS 98 (2007). Supporters of these laws believe that an apology would encourage doctors to disclose errors to patients, and force both parties to move towards reconciliation. Wei, supra, at 108.

Never Events share two important similarities to apologies. First, like apology-laws, Never Events were adopted for larger policy reasons a cost-cutting measure and an incentive for hospitals to improve care and not as an allocation or indication of fault. Second, like apology-laws, by removing Never Events from the courtroom, states would be encouraging disclosure and reconciliation. Specifically, legislatures would be encouraging the accurate reporting of preventable medical errors. Accordingly, legislatures should enact laws that forbid Never Events from being admitted as evidence in court.

(95) NAT'L QUALITY FORUM 2002, supra note 42; see supra note 43.

(96) Atul A. Gawande et al., Risk Factors for Retained Instruments and Sponges After Surgery, 348 NEW ENG. J. MED. 229, 230 (2003).

(97) See id. at 231.

(98) A. Gonzalez-Ojeda et al., Retained Foreign Bodies Following Intra Abdominal Surgery, 46 HEPATO-GASTROENTEROLOGY 808 (1999).

(99) Petra S. Berger & Gordon Sanders, Objects Retained During Surgery: Human Diligence Meets Systems Solutions, PATIENT SAFETY & QUALITY HEALTHCARE NEWSLETTER (Sept. 2008), available at http://www.psqb.com/sepoct08/ objects.html.

(100) Gawande, supra note 96, at 232.

(101) Cedars-Sinai Health Sys., Elimination of Retained Foreign Objects Task Force, http://www.csmc.educ/pf_11749.html (last visited May 3, 2010).

(102) A. Lincourt et al., Retained Foreign Bodies After Surgery, 138 J. SURGICAL RES. 170 (2007).

(103) Gonzalez-Ojeda et al., supra note 98.

(104) Id.

(105) Berger & Sanders, supra note 99.

(106) Gawande, supra note 96, at 232.

(107) See generally John R. Clarke et al., Getting Surgery Right, 246 ANNALS SURGERY 395 (2007) (reporting on state-wide incidents of wrong-site surgery in hospitals and ambulatory surgical centers).

(108) Id.

(109) Id.

(110) Lincourt et al., supra note 102.

(111) R.R. Cima et al., Incidence and Characteristics of Potential and Actual Retained Foreign Object Events in Surgical Patients, 207 J. AM. C. SURGEONS (2008).

(112) Gawande et al., supra note 96, at 234; see also Cima, supra note 111.

(113) U.S. Food & Drug Admin., Public Health Notification: Unretrieved Device Fragments (Jan. 15, 2008), http://www.fda.gov/cdrh/safety/ 011508-udf.html.

(114) Lincourt et al., supra note 102.

(115) Gwande, supra note 96.

(116) Id.

(117) Of the four NQF events that CMS considered adopting in its 2008 pro posed rule, wrong-site surgery is the only one that CMS did not select. Although commentators strongly urged for its adoption as an HAC, CMS could not fit the event into its pre-existing codes. See Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. 47,130, 47,218 (Aug. 22, 2007) (to be codified at 42 CFR pts. 411, 412, 413, and 489). However, some state Medicaid programs still received reimbursement requests for wrong-site surgery. See Medical News Today, New York Medicaid Program to Stop Reimbursing Hospitals for Preventable Errors (June 11, 2008), http://www.medicalnewstoday.com/articles/110769 .php.

(118) Mary R. Kwaan et al., Incidence, Patterns, and Prevention of Wrong-Site Surgery, 141 ARCHIVES SURGERY 353,354 (2006).

(119) Clarke et al., supra note 107, at 395.

(120) See Nancy M. Saufl, Sentinel Event sentinel event Health policy A term used by the JCAHO for a 'headliner' event that may cause an unexpected or unanticipated outcome or death, and trigger an investigation of a hospital's policies : Wrong-Site Surgery, 17 J. PERIANESTHESIA NURSING 420, 420 (2002).

(121) Id.

(122) Id.

(123) Joint Comm'n on Accreditation of Healthcare Orgs., Sentinel Event Alert: A Follow-up Review of Wrong Site Surgery (2001), http://www.jointcommission.org/ SentinelEvents/SentinelEventAlert/sea 24.htm.

(124) Clarke et al., supra note 107, at 402.

(125) Martin A. Makary et al., Operating Room operating room
n. Abbr. OR
A room equipped for performing surgical operations.
 Briefings and Wrong-Site Surgery, 204 J. AM. C. SURGEONS 236, 236 (2007) (citing Martin A. Makary, Patient Safety in Surgery, 243 ANNALS SURGERY 628, 628 (2006)).

(126) Joint Comm'n on Accreditation, supra note 123.

(127) Id.

(128) Press Release, N.Y. State Dep't of Health, New York State Health Department Releases Pre-Operative Protocols to Enhance Safe Surgical Care (Feb. 8, 2001), http://www.health.state.ny.us/press/releases/2001/preop.htm.

(129) Id.

(130) Id.

(131) James Defontes & Stephanie Surbida, Preoperative Safety Briefing Project, 8 PERMANENTE J. 21 (2004).

(132) Kwaan et al., supra note 118, at 355.

(133) Clarke et al., supra note 107, at 395.

(134) Cf Defontes et al., supra note 131 (addressing the problems of wrong anatomical site or wrong patient surgical procedures through an improved climate of communication among members on the surgical team).

(135) See generally Clarke et al., supra note 107.

(136) CMS focuses largely on the costs of care, which may not be synonymous with the standard of care. Accordingly, CMS selects events that have high costs over events that a hospital could truly prevent and could thereby improve the standard of care.

(137) See DerGurahian, supra note 88.

(138) Critics have pointed out numerous concerns with evidence-based guide lines in general. See generally Carter L. Williams, Evidence-Based Medicine evidence-based medicine Decision-making 'The use of scientific data to confirm that proposed diagnostic or therapeutic procedures are appropriate in light of their high probability of producing the best and most favorable outcome'. See Meta-analysis.  in the Law Beyond Clinical Practice Guidelines clinical practice guidelines Clinical policies, practice guidelines, practice parameters, practice policies Medtalk Systematically developed statements to assist practitioner and Pt decisions about appropriate health care for specific clinical circumstances. See Psychology. . What Effect Will EBM EBM Evidence-Based Medicine
EBM Electronic Body Music
EBM ecosystem-based management
EBM Evidence Based Medical (statistics)
EBM Environmentally Benign Manufacturing
EBM Expressed Breast Milk
EBM Executive Board Meeting
 Have on the Standard of Care?, 61 WASH. & LEE L. REV. 479 (2004). For example, evidence-based guidelines do not reflect common clinical experience, and advocate inconsistent legal standards. Id. at 500 (stating that the "current standard of care analysis is potentially inconsistent with the practice of evidence-based medicine"). Accordingly, CMS's second criteria for the selection a Never Event that it be reasonably preventable through the application of evidence-based guidelines does not necessarily reflect a widely approved standard in the medical profession. In other words, what CMS advocates as an evidence-based guideline may be contrary to medical standards of care. Id. Accordingly, a hospital that is faced with the possibility of a Never Event would have two choices: institute a standard contrary to the medical standards of care (and thereby open itself up to tort litigation) or provide the patient proper care without hope for reimbursement.

(139) Deficit Reduction Act of 2005, supra note 62.

(140) An estimated twenty-five million indwelling urethral urethral

pertaining to or emanating from urethra.


urethral agenesis, urethral atresia
failure of development of all or part of the urethra: characterized by complete urine retention. A rare cause of neonatal uremia.
 catheters sold in the United States annually. Sanjay Saint et al., Are Physicians Aware of Which of Their Patients Have Indwelling Urinary Catheters?, 109 AM. J. MED. 476, 476 (2000).

(141) KENRAD E. NELSON & CAROLYN M. WILLIAMS, INFECTIOUS DISEASE EPIDEMIOLOGY THEORY AND PRACTICE 522 (2nd ed. 2007).

(142) Heidi L. Wald & Andrew M. Kramer, Nonpayment for Harms Resulting in Medical Care: Catheter-Associated Urinary Tract Infections, 298 JAMA 2782, 2783 (2007).

(143) Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates, 72 Fed. Reg. 24,719-24,720.

(144) Id.

(145) Saint et al., supra note 140, at 476.

(146) APIC (Advanced Programmable Interrupt Controller) A circuit that handles the priority of interrupts in a computer. Designed to support symmetric multiprocessing (SMP), the APIC handles more interrupts and is more flexible than the programmable interrupt controller , Guide to the Elimination of Catheter-Associated Urinary Tract Infections 32 2008), http://www.apic.org/Content/NavigationMenu/ PracticeGuidance/APICEliminationGuides/CAUTI_Guide_0609.pdf.

(147) Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates, 72 Fed. Reg. at 24,719.

(148) APIC, supra note 146, at 8.

(149) Id.

(150) Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates, 72 Fed. Reg. at 24,719.

(151) Wald & Kramer, supra note 142.

(152) The report that CDC relies upon is EDWARD S. WONG, CTRS. FOR DISEASE CONTROL & PREVENTION, DEP'T OF HEALTH & HUMAN SERVS., GUIDELINE FOR PREVENTION OF CATHETER-ASSOCIATED URINARY TRACT INFECTIONS (1981), available at http://www.cdc.gov/ncidod/dhqp/gl_catheter_assoc.html; see Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. 47,130, 47,203-47,204. (Aug. 22, 2007) (to be codified at 42 CFR pts. 411, 412, 413, and 489).

(153) See id. at 47,204.

(154) Id.

(155) WONG, supra note 152.

(156) Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. at 47,203.

(157) APIC, supra note 146, at 8; see also Fred Bazzoli, Cigna the Latest to Say It Won't Pay For Preventable Medical Errors, HEALTHCARE FIN. NEWS, Apr. 21, 2008, http://www.healthcarefinancenews.com/story.cms?id=7935.

(158) See Wald & Kramer, supra note 142.

(159) Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates, 72 Fed. Reg. 24,719.

(160) See Wald & Kramer, supra note 142. (Aug. 22, 2007).

(161) Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. 47,130, 47,214 (Aug. 22, 2007) (to be codified at 42 CFR pts. 411, 412, 413, and 489).

(162) Letter from John Murphy, President, Am. Geriatrics Soc'y, to Kerry Weems, Acting Adm'r, Ctrs. for Medicare & Medicaid Servs. (Aug. 25, 2008), http://www.americangeriatrics.org/products/positionpapers/ HAC_letter2008.pdf.

(163) Pekka Kannus et al., Fall-Induced Injuries and Deaths Among Older Adults, 281 JAMA 1895, 1895 (1999).

(164) Id.

(165) Letter from Murphy, supra note 162, at 3.

(166) Kannus et al., supra note 163.

(167) See Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates, 72 Fed. Reg. 24,718.

(168) Id.

(169) Id. at 24,724-24,725.

(170) Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. 47,130, 47,214 (Aug. 22, 2007) (to be codified at 42 CFR pts. 411,412, 413, and 489).

(171) Id.

(172) Id. at 47,214-47,215.

(173) Mary E. Tinetti et al., Effect of Dissemination of Evidence in Reducing

Injuries From Falls, 359 NEW ENG. J. MED. 252 (2008).

(174) Id. at 252.

(175) Id. at 258.

(176) Id.

(177) See Tinetti et al, supra note 173.

(178) Letter from Murphy, supra note 162, at 3.

(179) Kannus et al., supra note 163, at 1898.

(180) "Patient Safety Indicators (PSIs) are a set of measures that screen for ad verse events that patients experience as a result of exposure to the health care system." Agency for Health Care Research & Quality, U.S. Dep't of Health & Human Servs., Patient Safety Indicators Fact Sheet (2006), http://qualityindieators.ahrq.gov/ downloads/psi/2006-Feb-PatientSafetyIndicators.pdf.

(181) Id.

(182) Id.

(183) Fisk, supra note 8.

(184) See supra Part III.A.

(185) See generally Fisk, supra note 8.

(186) Id.

(187) Dobson et al., define cost shifting as "systematically higher prices (above cost) paid by one payer group to offset lower prices (below cost) paid by another." Allen Dobson et al., The Cost-Shift Payment 'Hydraulic': Foundation, History, and Implications, 25 HEALTH AFF AFF Affectionate
AFF Affirmative
AFF Adult FriendFinder (website)
AFF American FactFinder (US Census data retrieval system)
AFF Accelerated Free Fall (type of skydiving training) 
. 22, 23 (2006).

(188) See id.

(189) See supra Section I.

(190) See supra Section I.

(191) See supra Section I.

(192) See supra Section I; see also James Schlett, Medicare Won't Pay For Hospital-Acquired Injuries, DAILY GAZETTE, Sept. 28, 2008, at C1.

(193) The Emergency Medical Treatment and Active Labor Act ("EMTALA") 42 USCA USCA®

An abbreviation for U.S. Code Annotated.
 1395; see also PETER R. KONGSTVEDT, MANAGED CARE: WHAT IS IT AND How IT WORKS 83 (3d ed. 2008); see also Diana K. Quinn et al., The Emergency Medical Treatment and Active Labor Act of 1985 and the Practice of Psychiatry, 53 PSYCHIATRY SERVICES 1301, 1303 (2002) (providing a brief summary of the Emergency Medical Treatment and Active Labor Act of 1985).

(194) Gov. Accountability Office, Emergency Care: EMTALA Implementation and Enforcement Issues GAO-01-747 at 13 (June 22, 2001) (explaining that "the 1999 Special Advisory Bulletin [clarifying EMTALA issues] hospitals should not obtain prior authorization from an individual's insurance company before screening or stabilizing treatment begins.").

(195) For a description of the IPPS billing system, and the use of Present-On- Admission codes, see supra note 77 and accompanying text.

(196) Quinn et al., supra note 193, at 1301 (stating that "the intent of this legislation is not to punish physicians or hospitals but to protect patients and health care providers from economic, institutional and political pressures that might compromise health care providers' ability to evaluate and treat patients who are seeking emergency care").

(197) A pressure ulcer forms when an area of skin remains in one position for an extended period of time, due to the patient's inability to shift their body. Univ. of Md. Med. Ctr., Pressure Ulcer--Overview (2008), http://www.umm.edu/ency/article/ 007071.htm. There are five factors that make a person more susceptible to a pressure ulcer: immobility, inactivity, nutritional factors, fecal and urinary incontinence Urinary Incontinence Definition

Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it.
, and decreased sensory perception. Wound Care lnfo. Network, Staging Pressure Ulcers (2008), http://www.medicaledu.com/staging.htm. Hence, pressure ulcers often exist among obese patients, who are immobile, inactive, and have poor nutritional factors. Pressure ulcers exist in four separate stages, with symptoms ranging from "changes in ... skin temperature" (phase one) to "full thickness skin loss with extensive destruction" (phase four). Wound Care Info. Network, supra. Thus, a patient with a phase I pressure ulcer could enter a hospital with an unidentified pressure ulcer and have no visible symptoms. CMS responds to this by stating, "by selecting this condition, we would provide hospitals the incentive to perform careful examination of the skin of patients on admission to identify [pressure] ulcers." Final Rule Regarding Changes to the Medicare Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. 47,203

(198) EMTALA, supra note 193; see also KONGSTVEDT, supra note 200. This is because the hospital will not have the proper present-on-admission coding. For a brief description of IPPS coding, and Present-on-Admission coding, see Linda Wilson, POA Coding Challenges: Concern Grows over Quality of Documentation, MODERN HEALTHCARE, June 2, 2008, at 10.

(199) "A violation of EMTALA can result in fines of up to $50,000 per violation ... and loss of Medicare reimbursement." Quinn et al., supra note 193, at 1301.

(200) See Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems, 72 Fed. Reg. 47,130, 47,216 (Aug. 22, 2007) (to be codified at 42 CFR pts. 411, 412, 413, and 489).

(201) See supra Section III.

(202) Press Release, Nat'l Quality Forum, supra note 90.

(203) For a workable definition of medical errors, see Wu et al., supra note 6.

(204) This list intentionally excludes wrong-site surgery a NQF condition that CMS proposed but ultimately could not fit into its payment codes.

(205) Alternatively, CMS could abandon the requirement altogether. For a discussion on the problems with evidence-based guidelines, see supra, note 138.

(206) NAT'L QUALITY FORUM SRE, supra note 45. As discussed above, some consider NQF's process to be the "gold standard" of health care measurement. See Press Release, Nat'l Quality Forum, supra note 50.

(207) See supra Section I.

John Crist, J.D., Case Western Reserve University of Law, May 2010. M.B.A., Weatherhead School of Management The Weatherhead School of Management is a private business school of Case Western Reserve University located in Cleveland, Ohio. Weatherhead is considered a top-tier business school, with its strongest programs concentrated in organizational behavior, nonprofit business,  at Case Western Reserve University, May 2010. I am grateful to Professor Sharona Hoffman for her advice and guidance during the writing of this note.
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