There has been a lot of talk lately about so-called “never events.” In 2002, the National Quality Forum (NQF) endorsed a list of 27 events that it deemed should be reported by all licensed healthcare facilities due to their preventable nature. The NQF’s list was updated in 2006 to include an additional event, bringing the total number of “never events” to 28. The NQF defines these events as those that should theoretically never happen in the hospital setting.

Pursuant to the Deficit Reduction Act of 2005, the Centers for Medicare, and Medicaid Services (CMS) began selecting hospital-acquired conditions (HACs) that were determined to be reasonably preventable. If a condition is not present upon admission, but is subsequently acquired during the hospital stay, Medicare will no longer pay the additional cost of the hospitalization. These HACs were largely adopted from the NQF’s list of “never events.” CMS had proposed eight new HACs in 2008. After public comment, only three new HACs were adopted for 2009, bringing the current number to 11. The three new HACs include:

  • Surgical site infections following certain elective procedures, including certain orthopedic surgeries, and bariatric surgery for obesity.
  • Certain manifestations of poor control of blood sugar levels; and
  • Deep vein thrombosis or pulmonary embolism following total knee replacement and hip replacement procedures.

These three new HACs will be added to the following list of eight preventable conditions for which additional Medicare payment will be denied: Foreign objects retained after surgery; Air embolism; Blood incompatibility; Stage III and IV pressure ulcers; Falls and trauma; Catheter-associated urinary tract infections; Vascular catheter-associated infections; and Mediastinitis after coronary artery bypass graft.

In addition to the obvious budgetary concerns, “never events” and HACs raise serious questions in terms of liability and risk management. The fact is that many of these “never events” can and do occur in the absence of negligence. While most would agree events such as operating on the wrong side of a patient’s body should never happen, there are less obvious instances in which “never events” simply are not preventable. For example, a patient may attempt to ambulate without assistance in contravention of their doctor’s orders, thereby sustaining injury as the result of a fall. There are also instances in which a patient’s physical condition may predispose them to injury; an example being the diabetic patient who develops pressure ulcers despite a hospital’s best efforts towards prevention.

A growing worry in the insurance defense community is that the NQF’s growing list of “never events” may increase the risk of litigation. Following Medicare’s lead, some of the larger insurance companies such as Aetna and WellPoint have incorporated “never events” into their coverage contracts. Patients may increasingly find themselves without insurance coverage for hospital treatment arising from a “never event.” This will provide added incentive for patients to bring legal action against the hospital. There is also the very real threat that “never events” will morph into a new arena of strict liability. Should it become accepted that these events should never happen, then it follows that there would be no defense to their occurrence. It is also possible that “never events,” while perhaps not quite reaching the level of strict liability, may instead be used to redefine the community standard of care for physicians charged with medical negligence.

Medicare will undoubtedly continue adding to its list of “never events,” and the insurance industry appears to be following suit, seeing the same potential as the government does in what these policies could mean for its bottom line. There are also a growing number of state governments that are taking a proactive approach to this issue. Pennsylvania and New York Medicaid agencies have enacted policies of non-payment for certain “never events.” Maine has enacted legislation prohibiting providers from billing for any “never events.” Under California law, hospitals are required to report the occurrence of any of the 28 “never events.” Beginning January 1, 2009, the California Department of Public Health began making reports of substantiated “never events” available to the public, as well as any subsequent investigations or inspections. By January 1, 2015, this information must be posted on the California Department of Public Health’s website.

Several hospitals have begun voluntarily agreeing to non-payment for “never events.” Some of the hospital acquiescence may be attributable to The Leapfrog Group, a private organization which has been applying pressure to hospitals to adopt policies including waiving all costs connected to a never event; apologizing to the patient and/or family; reporting the event to at least one agency; and performing a root cause analysis consistent with instructions from the chosen reporting agency.

What does this all mean for hospitals and healthcare professionals? The simple answer is increased vigilance. If a condition is not present upon admission, but is subsequently acquired during the hospital stay, it is the hospital, not Medicare, who will ultimately be responsible for the additional cost of the hospitalization. Given the current economic crisis, increasing costs are something hospitals and healthcare professionals cannot afford. Screening patients upon admission becomes increasingly important considering CMS’s newly expanded list of HACs. Any sign of infection or ulcers must be thoroughly documented to prevent future payment disputes and, of course, to dissuade malpractice suits. Hospitals made need to reevaluate their standard protocols for treating patients or even the products they are accustomed to using. Anything that can reduce the instance of HACs must be considered. It is also imperative hospitals provide additional training to their entire staff in this regard, not just doctors and nurses. Not only should staff be familiar with “never events” and their implication on the hospital’s bottom line, but they must also be instructed on proper procedure for prevention of these events.

These new regulations may be cumbersome in their implementation, and the jury is out on whether they will increase the quality of healthcare. However, regardless of their efficacy in improving the quality of treatment, the simple fact is that “never events” and HACs are here to stay. The sooner hospitals take proactive steps to address their impact, the better able they will be able to adapt and continue providing their services to the public.

If the reader has further questions regarding “never events,” or for more detailed information on the new CMS regulations, we welcome you to contact our law firm. We have significant experience in litigating complex professional negligence and elder abuse actions and would be more than happy to assist you in navigating these regulatory changes.