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Navigating CMS’s “Never Events”
Laura Loeb, JD*
King & Spalding LLP
Washington, DC, USA
George Sample, MD**
Washington Hospital Center
Washington, DC, USA
The Centers for Medicare and Medicaid Services (CMS) in October added three conditions to its list of non-reimbursable hospital-acquired conditions (HACs). Deemed “never events,” if these conditions occur after a patient’s hospital admission, CMS will make no additional payments related to the treatment of these complications.
CMS had planned to add up to nine conditions to the HAC list, but after receiving numerous comments from physician and hospital groups, it adopted only three new conditions: poor glycemic control, surgical site infection and deep vein thrombosis/pulmonary embolism.
The Society of Critical Care Medicine (SCCM), working with leaders from other professional healthcare organizations, was among those to submit comments to CMS. Representatives from SCCM, the American College of Chest Physicians, the American Thoracic Society, the National Association for Medical Direction of Respiratory Care, the American Association of Critical-Care Nurses and the American Association for Respiratory Care collaborated to send a formal letter to CMS expressing concern that many of the proposed conditions could not be deemed 100% preventable. Even with the strictest adherence to evidence- based guidelines, there will always be a case rate for some of the conditions; many could be considered “reducible,” but are “not completely preventable.” The group also argued that preventive measures for some proposed conditions have not been established or have not been proven conclusively in the peer-reviewed literature. In its final ruling, CMS rejected recommendations from SCCM and other organizations, deciding that conditions may be added if they are “reasonably preventable.” With this criteria, CMS added to its list the following conditions.
Poor Glycemic Control – The Society and its partners cited recent studies demonstrating that tight glycemic control in septic patients leads to poorer outcomes. CMS countered that argument, saying that manifestations of poor glycemic control are reasonably preventable through the application of evidence-based guidelines. Specifically, it argued that they are preventable through routine serum glucose measurement and control. This condition also was included in the National Quality Forum’s (NQF) list of Serious Reportable Adverse Events.
Surgical Site Infection – Other organizations, including the American College of Orthopedic Surgeons/Osteopathic Academy of Orthopedics, raised concerns that patient characteristics and other factors can place patients at risk for surgical site infections, even if best practice guidelines are followed. CMS noted that categorizing surgical site infections as non reimbursable will increase attention to these risk factors prior to surgery. The agency also noted that many risk factors, such as morbid obesity or diabetes, are considered complications that would place the surgery in a higher-paying diagnosis-related group anyway. Therefore, the advent of a surgical site infection would not prevent such occurrences from being reimbursed at the higher payment level. Given this, CMS argued that surgical site infection after certain orthopedic procedures (e.g., repair, replacement or fusion of various joints) and after bariatric surgery for obesity should be included on the HAC list. In future years, CMS also may consider adding infection following certain cardiac device procedures.
Deep Vein Thrombosis/ Pulmonary Embolism –The Society cited several studies to show that deep vein thrombosis/ pulmonary embolism were reducible events, but not 100% preventable preventable. It noted that it was not possible to recognize all deep vein thrombosis/pulmonary embolism events upon admission and stated that these conditions lack standard clinical definitions and diagnostic criteria. However, CMS rejected these arguments, stating that the conditions on this list only had to be reasonably preventable. CMS added deep vein thrombosis occurring after knee or hip replacement surgery to its final ruling.
After considering comments, six other conditions being considered were not added to the final ruling: delirium, ventilator-associated pneumonia, Staphylococcus aureus septicemia, Clostridium difficile-associated disease, Legionnaires disease and iatrogenic pneumothorax. The formal joint letter, which outlines recommendations for most of these conditions, can be found in the Public Health and Policy section of www.sccm.org.
Background
The genesis of non-reimbursable “never events” came out of efforts to improve quality of care and reduce medical errors, a priority for Congress and CMS ever since the Institute of Medicine issued its 1999 landmark report, To Err is Human. (1) That report showed HACs caused by medical errors to be a leading cause of morbidity and mortality in the United States, noting that as many as 98,000 patients die each year as a result of medical errors.
In 2000, the Centers for Disease Control and Prevention (CDC) estimated that hospital-acquired infections add nearly $5 billion to U.S. healthcare costs every year. (2) Further, a 2007 survey conducted by The Leapfrog Group found that 87% of 1,256 surveyed hospitals did not follow recommendations to prevent many of the most common hospitalacquired infections. (3)
In 2005, Congress authorized CMS to reduce Medicare inpatient payments to hospitals for certain HACs. If the agency determined that certain conditions could be prevented by following evidence-based guidelines, these could be categorized as non-reimbursable. Some physicians and hospitals have questioned whether these new programs will indeed promote better care or will simply penalize hospitals and physicians for circumstances beyond their control.
Physician Payment Linked To Performance
The belief is that it is only a matter of time before CMS will mount some effort to reduce physician payment for not preventing certain conditions and complications. CMS continues to offer small bonuses for physicians who report certain quality measures. For 2009, the bonus for quality measure reporting under the Physician Quality Reporting Initiative (PQRI) will be 2%.
References
1. Kohn LT, Corrigan JM, Donaldson MS (Institute of Medicine). To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 2000.
2. Centers for Disease Control and Prevention. Hospital infections cost U.S. billions of dollars annually. Available at: http://www.cdc.gov/od/oc/media/pressrel/r2k0306b.htm . Accessed December 8, 2008.
3. The Leapfrog Group. Eighty-seven percent of hospitals do not take recommended steps to prevent avoidable infections. Available at: http://www.leapfroggroup.org/media/file/Leapfrog_hospital_acquired_infections_release.pdf .Accessed December 8, 2008.
Disclosures
*Author has no disclosures to report
**Author has no disclosures to report
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