On June 13, 2008, the American Association of Orthopaedic Surgeons (AAOS) submitted a comment to the Centers for Medicare and Medicaid Services (CMS) on the hospital-acquired condition (HAC) payment policy for fiscal year 2009 inpatient prospective payment system. The following excerpts are from that comment.

General concerns regarding HAC policy
The AAOS … support[s] a payment system that reflects quality care, including withholding payment for certain “never events.” However, we are concerned that including complications other than true “never events” on the list of preventable HACs requires prudence and caution to minimize the risk of potential large-scale unintended consequences that may negatively impact patient access and quality of care…

Our primary concern with the HAC policy is its inability to adjust for condition/procedure and patient-specific risk factors. Both are necessary to apply to conditions that are not considered “never events.”

CMS must implement a multi-faceted approach to risk adjustment [that] take[s] into account the condition-specific and procedure-specific risk that would affect the preventability. Many hospitalized patients have comorbidities and other patient characteristics that put them at an increased risk of complications. CMS must take these factors into account to create a policy that is truly reasonable and equitable.

Another concern in regard to the HAC policy is its inability to account for the practice of evidence-based medicine…. Evidence-based guidelines are recommended processes and could be captured in quality measures. We believe this would be the appropriate way to incentivize following evidence-based guidelines and preventing an inequitable payment policy….

Another area of concern is that of professional liability. With risk adjustment mechanisms in their infancy and an inefficient tort system, the possibility that nonpayment for particular conditions and injuries contribute to litigation is likely and particularly inappropriate in the context of conditions that are not 100 percent preventable.

DVT and PE
The AAOS supports the routine use of VTE (venous thromboembolism) prophylaxis in orthopaedic surgery and believes it is the standard of care. We believe that CMS is already taking positive steps toward the reduction of DVT and PE by proposing to implement six VTE hospital quality measures from the VTE project on Jan. 1, 2009.

The AAOS agrees that DVT and PE are both major quality concerns for patients and resource concerns for hospitals and CMS. However, we have several concerns regarding labeling these conditions as “reasonably preventable” hospital-acquired conditions.

Currently, there is no evidence that DVT/PE is reasonably preventable in certain high-risk orthopaedic procedures. As cited in the AAOS, American College of Chest Physicians, and Institute for Clinical Systems Improvement guidelines, trauma and joint replacement patients are at the highest risk for DVT/PE is caused by venous trauma and stasis…. Clinical experience and evidence-based guidelines indicate DVT to be an unavoidable consequence in certain high-risk patients who undergo certain procedures. Even the best application of prophylaxis cannot prevent clot formation in every patient…. In addition, trauma and joint replacement patients have an increased risk of major bleeding, a risk that is increased in patients who receive pharmacologic VTE prophylaxis.

[I]t is important to balance the risks of both DVT/PE and major bleeding to maximize quality and patient outcomes in orthopaedic patients. The value of a physician’s ability to analyze and weigh all risks should not be impeded by a policy that incorrectly estimates the preventability of DVT/PE.

Surgical site infection in TKR
The AAOS supports…the development of clearly identified measures and validated surveillance systems to prevent surgical site infection. No surveillance system has been validated, however, and the true rate of nosocomial surgical site infection (SSI) in orthopaedic surgery is not well understood.

TKR is a successful orthopaedic procedure yet, like any other surgical procedure, it carries risks of complication which can be elevated based on an individual patient’s risk factors… TKR patients have generally low risk profiles, but we are concerned about a payment system that offers an incentive to disproportionately treat some patients but not others because of the risk of possible but manageable complications.

Even when practicing the best evidence-based medicine, including administration of appropriately selected preoperative antibiotics and discontinuation of antibiotics within 24 hours postoperatively, certain patients who undergo TKR will still develop SSI. Therefore, it is important to recognize this level of unavoidability and apply a method of risk adjustment that can adequately encompass the relevant risk factors. We believe that without risk adjustment the system creates a disincentive to treat patients who are at increased risk for infection.