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Sunday, August 19, 2007

Insuarance: Medicare Won't Pay for Certain Preventable Procedures (eg., hospital acquired infections); however, the patient cannot be billed for these either, and hospitals will absorb expense. But has a purely preventable Pandora's box been presented?

UPDATED 8/20/2007:  Here is a link to the Medicare Press release  (also printed below the fold of this post)

In this recent story on Medicare NOT paying for certain preventable procedures ("Medicare won't pay if hospitals err"), what was left way under the fold was the fact that the medical provider will not be able to be the patient for these procedures that Medicare has denied payment. 

I have three quick remarks on this story as a unanswered questions are not present and their implications on not only payment, but on patient care and claims with a Pandora's box been presented over the issues of purely preventable medical procedures?

First, some of the stories address the large number of infections acquired by patients' stays at hospitals - "The Atlanta-based U.S. Centers for Disease Control and Prevention estimates patients develop 1.7 million infections in hospitals each year, and it says those infections cause or contribute to the death of 99,000 people a year —- about 270 a day."

What an interesting twist this would have had if the Medicare procedures would have been in effect at the time of the infections occurred which served as the basis of the suit against Jewish Hospital, and their relevance not only in the claim of medical negligence, but now with regard to the hospital's smack down counter suit against the attorneys for filing the suit against the hospital in the first place.  This lawsuit was eventually dropped by the attorneys due to the high cost of prosecuting the claim.  Although the legal admissibility of the evidence would have been the subject of debate then and now, the effect on the public perception of the problem and the countersuit is enormous and puts the lawyers' actions lawsuit against the hospital in a much more favorable light.  If nearly a 100,000 people die each year from hospital-developed infections with 1.7 million people getting infected each year, do you really need an expert prior to filing suit?  Can anyone really fault attorneys for filing such a suit in the first place? 

Second,  no "balance billing" of the patient for Medicare-denied reimbursement is good news at billing time, but will it have any impact on the quality of the procedures provided in futuro?  The story addresses the obvious human response of more diagnostic testing which would document when the infection occurred, and if it is found that the infection occurred PRIOR to the hospital stay, then what? 

Well, the "then what" presents an unusual situation when such infections, bed sores, or other conditions were acquired separate from the hospital stay and the hospital infection control team is left with the cleaning up after another's purely preventable problem?  Does the hospital treat the patient and then seek indemnity from the putative cause of the problem (nursing home, physician)?  And who should ultimately pay for these tests for causation?

Pressure sores (bed sores, decubiti) are generally considered by many to be preventable by proper care.  Nonetheless they persist.  However, in the area of medical negligence claims, the standard defense is typically one of causation and casting a finger of blame elsewhere.

Third, if and when private health insurers join in with the problem, then you have the same questions as to balance billing, medical negligence, and causation of the problem; not to mention the question of continued care. 

Fourth, when does the fact that the government and health insurers all question payment for bed sores and certain other conditions solely based upon potential prevention rise to the level of negligence per se and/or res ipsa loquitor on the questions of medical negligence and the degree of proof or need for experts?

Medicare won't pay if hospitals err
By ROBERT PEAR
The New York Times

WASHINGTON — Bush administration officials say Medicare will no longer pay the extra costs of treating preventable errors, injuries and infections that occur in hospitals.

The rule change is among several initiatives the administration says are intended to improve the accuracy of Medicare's payment for hospital patients who receive acute care and to encourage hospitals to improve the quality of their services.

Private insurers are considering similar changes.

Consumer groups welcomed the change, set forth in rules to be published Wednesday. While hospital executives endorsed the goal of patient safety, they said the policy would require them to collect large amounts of data they do not now have.

Under the new rules, Medicare will not pay hospitals for treating certain "conditions that could reasonably have been prevented."

Among the conditions that will be affected are bedsores, or pressure ulcers; injuries caused by falls; and infections resulting from the prolonged use of catheters in blood vessels or the bladder.

In addition, Medicare says it will not pay for the treatment of "serious preventable events," such as leaving a sponge or other object in a patient during surgery or providing a patient with incompatible blood or blood products. * * *

The rules implement a directive from Congress included in a 2006 law. When the rules were proposed in May, consumer advocates said they feared some hospitals might charge patients for costs that Medicare refused to pay.

But that is forbidden. "The hospital cannot bill the beneficiary for any charges associated with the hospital-acquired complication," the final rules say. Hospitals, instead, will be expected to pick up the extra cost. * * *

Eileen O'Neill-Pardo of Everett, Wash., said her experience showed the need for the rules. Her 82-year-old mother, Margaret O'Neill, died of an infection that developed during intestinal surgery at a Seattle hospital in 2004.

"The operation —- to remove scar tissue —- was successful, but the patient died," O'Neill-Pardo said.

The Atlanta-based U.S. Centers for Disease Control and Prevention estimates patients develop 1.7 million infections in hospitals each year, and it says those infections cause or contribute to the death of 99,000 people a year —- about 270 a day.

Some studies:

  • The Impact of Hospital-Acquired Bloodstream Infections
    Richard P. Wenzel and Michael B. Edmond
    Medical College of Virginia, Virginia Commonwealth University, Richmond, Virginia, USA

    Nosocomial bloodstream infections are a leading cause of death in the United States. If we assume a nosocomial infection rate of 5%, of which 10% are bloodstream infections, and an attributable mortality rate of 15%, bloodstream infections would represent the eighth leading cause of death in the United States. Because most risk factors for dying after bacteremia or fungemia may not be changeable, prevention efforts must focus on new infection-control technology and techniques.
  • CDC Infection Tracking System Now Available to All U.S. Hospitals

    A secure, Web-based reporting network that lets facilities track infections associated with health care is now available to all health care facilities in the United States, the Centers for Disease Control and Prevention (CDC) announced today.

    The National Healthcare Safety Network (NHSN) provides multiple options for data analysis and more flexibility for sharing information both within and outside a facility -- including the general public, if the facility so chooses.
  • Essentials of Public Reporting of Healthcare-Associated Infections: A Tool Kit PDF 255KB / 4 pages
    Published: January 2007
  • Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006 PDF 235KB

    New HICPAC guideline on the management of multidrug-resistant organisms in healthcare settings.

updated with medicare press release:::::::

For Immediate Release: Thursday, May 18, 2006
Contact: CMS Office of Public Affairs
202-690-6145

ELIMINATING SERIOUS, PREVENTABLE, AND COSTLY MEDICAL ERRORS - NEVER EVENTS

OVERVIEW:

As part of its ongoing effort to pay for better care, not just more services and higher costs, the Centers for Medicare & Medicaid Services (CMS) today announced that it is investigating ways that Medicare can help to reduce or eliminate the occurrence of “never events” – serious and costly errors in the provision of health care services that should never happen.  “Never events,” like surgery on the wrong body part or mismatched blood transfusion, cause serious injury or death to beneficiaries, and result in increased costs to the Medicare program to treat the consequences of the error.

BACKGROUND:

According to the National Quality Forum (NQF), “never events” are errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients, and that indicate a real problem in the safety and credibility of a health care facility.  The criteria for “never events” are listed in Appendix 1.  Examples of “never events” include surgery on the wrong body part; foreign body left in a patient after surgery; mismatched blood transfusion; major medication error; severe “pressure ulcer” acquired in the hospital; and preventable post-operative deaths.  NQF’s full list is included in Appendix 2.  NQF developed this list with support from CMS.

While the exact number of “never events” is not known, they result in many deaths and additional health care costs.  In 1999, the Institute of Medicine (IOM) estimated that as many as 98,000 deaths a year were attributable to medical errors, and recommended that error-related deaths be decreased by 50 percent over five years.  A second study concluded that “never events” add significantly to Medicare hospital payments, ranging from an average of an additional $700 per case to treat decubitus ulcers to $9,000 per case to treat postoperative sepsis.  Another study, reviewing 18 types of medical events, concluded that medical errors may account for 2.4 million extra hospital days, $9.3 billion in excess charges (for all payers), and 32,600 deaths.

Some states have enacted legislation requiring reporting of incidents on the NQF list.  For example, in 2003, the Minnesota legislature, with strong support from the state hospital association, was the first to pass a statute requiring mandatory reporting of “never events”.  The Minnesota law requires hospitals to report the NQF’s 27 “never events” to the Minnesota Hospital Association’s web-based Patient Safety Registry.  The law requires hospitals to investigate each event, report its underlying cause, and take corrective action to prevent similar events.  In addition, the Minnesota Department of Health publishes an annual report and provides a forum for hospitals to share reported information across the state and to learn from one another.

During the first year of Minnesota ’s mandatory reporting program, 30 hospitals reported 99 events that resulted in 20 deaths and four serious disabilities.  In the second year, 47 hospitals reported 106 events that resulted in 12 deaths and nine serious injuries.  These included 53 surgical events, and 39 patient care management events.  A more detailed listing of the most recent Minnesota findings is attached as Appendix 3.

In 2004, New Jersey  enacted a law requiring hospitals to report serious, preventable adverse events to the state and to patients’ families, and Connecticut adopted a mix of 36 NQF and state-specific reportable events for hospitals and outpatient surgical facilities.  An Illinois law passed in 2005 will require hospitals and ambulatory surgery centers to report 24 “never events” beginning in 2008.   Several other states have considered or are currently considering never event reporting laws.

Questions have been raised about whether such mandatory reporting leads to accurate estimates, because of the continued potential for underreporting of “never events.”  Even with incomplete estimates, it is clear that, while there has been improvement in some areas of quality and safety since the IOM report, our health care system still has not reached the IOM’s goal of a 50 percent reduction in the number of deaths due to medical errors.  Consequently, working with provider associations and other public and private groups, the Centers for Medicare & Medicaid Services is taking further steps to prevent “never events.”

NEXT STEPS:

From its beginning, the Medicare program has generally paid for services under fee-for-service payment systems, without regard to quality, outcomes, or overall costs of care.  In the past several years, CMS has been working with provider groups to identify quality standards that can be a basis for public reporting and payment.  This includes the efforts of the Hospital Quality Alliance, which has developed an expanding set of quality measures. As a result of the Medicare Modernization Act and the Deficit Reduction Act, hospitals that publicly report these quality measures receive higher Medicare payment updates.  In addition, CMS has launched a number of demonstrations aimed at improving quality of care, including by tying payment to quality.  These include the Physician Group Practice Demonstration, the Premier Hospital Quality Incentive Demonstration, the Health Care Quality Demonstration, and the Care Management Performance Demonstration.  As the results of these demonstrations become available, CMS expects to work with Congress on legislation that would support adjusting payments based on quality and efficiency of care.

Clearly, paying for “never events” is not consistent with the goals of these Medicare payment reforms.  Reducing or eliminating payments for “never events” means more resources can be directed toward preventing these events rather than paying more when they occur.  The Deficit Reduction Act represents a first step in this direction, allowing CMS, beginning in FY 2008, to begin to adjust payments for hospital-acquired infections.  CMS is interested in working with our partners and Congress to build on this initial step to more broadly address the persistence of “never events.”

In particular, CMS is reviewing its administrative authority to reduce payments for “never events,” and to provide more reliable information to the public about when they occur.  CMS will also work with Congress on further legislative steps to reduce or eliminate these payments. CMS intends to partner with hospitals and other healthcare organizations in these efforts.

# # #

APPENDIX 1

CRITERIA FOR INCLUSION ON THE NEVER EVENT LIST

To be included on NQF’s list of “never events”, an event had to have been characterized as:

Unambiguous—clearly identifiable and measurable, and thus feasible to include in a reporting system;
Usually preventable—recognizing that some events are not always avoidable, given the complexity of health care;
Serious—resulting in death or loss of a body part, disability, or more than transient loss of a body function; and
Any of the following:
Adverse and/or,
Indicative of a problem in a health care facility’s safety systems and/or,
Important for public credibility or public accountability.
APPENDIX 2

CURRENT NATIONAL QUALITY FORUM LIST OF “NEVER EVENTS”

Surgical Events

Surgery performed on the wrong body part
Surgery performed on the wrong patient
Wrong surgical procedure on a patient
Retention of a foreign object in a patient after surgery or other procedure
Intraoperative or immediately post-operative death in a normal health patient (defined as a Class 1 patient for purposes of the American Society of Anesthesiologists patient safety initiative

Product or Device Events

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 air embolism that occurs while being cared for in a healthcare facility

Patient Protection Events

Infant discharged to the wrong person
Patient death or serious disability associated with patient elopement (disappearance) for more than four hours
Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a healthcare facility

Care Management Events

Patient death or serious disability associated with a medication error (e.g., error 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 reaction due to the administration of ABO-incompatible blood or blood products
Maternal death or serious disability associated with labor or delivery on a low-risk pregnancy while being cared for in a healthcare facility
Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility
Death or serious disability (kernicterus) 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

Environmental Events

Patient death or serious disability associated with an electric shock while being cared for in a healthcare facility
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 substances
Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility
Patient death associated with a fall 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

Criminal Events

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 a healthcare facility
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 a healthcare facility
APPENDIX 3

RESULTS OF MINNESOTA  ’S SECOND YEAR “NEVER EVENT” REPORTING

Surgical Events (53 events):

Foreign objects left in patients after surgery (26 events),
Wrong body part (16 events),
Wrong procedure (8 events),
Intra/post-op death (1 event), and
Wrong patient (2 events).

Care Management Events (39 events):

Stage three and four pressure ulcers (31 events),
Death or disability due to medication error (7 events), and
Death or disability associated with hypoglycemia (1 event).

Other Events

Other “never events” reported from the environmental (4 events), products or devices (6 events), patient protection (1 event), and criminal (3 events) categories included:

Death associated with a fall (3 events),
Death or disability associated with restraints (1 event),
Misuse or malfunction of device (4 events),
Contaminated drugs, devices or biologics (1 event),
Intravascular air embolism (1 event),
Suicide or attempted suicide (1 event),
Sexual assault of a patient (2 events), and
Death or injury of patient or staff from physical assault (1 event).

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