This article is more than 5 years old. Information may no longer be current.
CMS may adopt VTE performance measures, but some orthopedists are concerned
If endorsed by the National Quality Forum, some orthopedic surgeons may face changing how they prevent venous thromboembolism.
The National Quality Forum will soon vote on whether to endorse two quality performance measures for monitoring how well hospitals manage the risk for venous thromboembolism among surgery patients.
But some orthopedists are unhappy with the proposals and told Orthopedics Today the new measures may force them to apply unnecessary prophylaxis measures.
The Centers for Medicare and Medicaid Services (CMS) developed the proposed measures with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) as part of the Surgical Care Improvement Project (SCIP). It then submitted them to the National Quality Forum (NQF) for endorsement. The NQF’s Board of Directors were to vote on the measures mid- May.
A formal endorsement would effectively create voluntary consensus standards for administering venous thromboembolism (VTE) prophylaxis, which CMS could use for public reporting.
If endorsed, hospitals can begin voluntarily collecting data on the two measures beginning in October.
|
The proposed measures have some orthopedists concerned. The candidate consensus standards are closely based on recommendations in the American College of Chest Physicians (ACCP) 2004 guidelines. These guidelines address VTE prevention across all types of inpatient surgery, focusing on use of aggressive chemoprophylaxis agents, including low molecular weight heparin, fondaparinux (Arixtra, GlaxoSmithKline) and warfarin. Some orthopedists feel the recommendations may not be entirely applicable to their patients and may force them to apply treatments that are not in their patients’ best interests, according to Paul A. Lotke, MD, a professor of orthopedic surgery at the University of Pennsylvania.
Surgical advances over the past decade, such as early mobilization, regional anesthesia, and surgical techniques with shorter operating times and less tissue trauma, all have contributed to reduce the risk of thromboembolic disease. “Because of that, we have to be careful about choosing an anticoagulant, which now may be more risky than the disease we are trying to prevent,” Lotke told Orthopedics Today.
Voluntary consensus standards
The NQF works under a formal, open process, which allows for public comment, a formal vote and an appeals process. It also involves all health care stakeholders, such as purchasers, consumers and providers.
Endorsed measures receive special legal status as voluntary consensus standards. This means that under federal law, if CMS imposes any sort of standards, it must use voluntary consensus standards when such standards exist unless it can explain otherwise, according to Philip Dunn, NQF vice president of communications and public affairs.
The bottom line for orthopedic surgeons is that once once adopted, the voluntary standards could eventually become mandatory — possibly before the end of 2007.
|
At present, two VTE performance measures are candidates for NQF endorsement. The first deals with “the proportion of patients who have appropriate VTE prophylaxis ordered.” The second deals with “the proportion of the patients who have appropriate prophylaxis actually administered within 24 hours before or after surgery,” according to Dale Bratzler, DO, MPH, co-chair of the NQF’s Venous Thromboembolism Prevention and Care Technical Advisory Panel.
Once endorsed by the NQF, CMS considers the measures endorsed for public reporting. Thus, hospitals that begin voluntarily collecting VTE performance data in October, should they submit it to CMS, could find the data publicly reported on the Web site hospitalcompare.hhs.gov, which is maintained by the Department of Health and Human Services.
Not guidelines per se
Bratzler noted that the performance measures — or consensus standards — are not guidelines per se: Clinical practice guidelines are typically published by specialty societies following a comprehensive evidence-based literature review and provide specific recommendations. The NQF performance measures, though based on the ACCP guidelines, are instead intended to measure the quality of a hospital’s care.
“When the NQF endorses performance measures, they are considered suitable for public reporting of quality,” said Bratzler, who is also medical director of the Oklahoma Foundation for Medical Quality in Oklahoma City. “Essentially, we are creating performance measures to assess hospital compliance with recommendations that are published in guidelines. It’s really used for assessment of quality of care.”
Bratzler added that CMS could eventually add the VTE performance measures to the list of those CMS requires hospitals to report to receive full annual Medicare payment updates. Under the Deficit Reduction Act recently passed by Congress, CMS must define quality measures that hospitals must report publicly or possibly face losing up to 2% of their annual Medicare payment update. Currently, CMS has 10 NQF-endorsed consensus standards, and hospitals that do not report on them lose 0.4% of their annual Medicare update.
“These VTE measures are not to that point yet,” Bratzler noted. “But I think it is quite reasonable to expect that down the road, because VTE is considered such a huge problem nationally.”
Areas of conflict, concern
The performance measures primarily focus on identifying VTE risk factors and implementing appropriate prophylaxis. In this respect, orthopedists are actually already substantially ahead of the rest of medicine, given that VTE is a major concern for hip fracture and hip and knee replacement patients.
|
The problem: how the measures define “appropriate prophylaxis,” notes Vincent Pellegrini Jr., MD, professor and chair of the department of orthopedics at the University of Maryland School of Medicine, Baltimore, and a member of the NQF’s VTE Prevention and Care Technical Advisory Panel.
Pellegrini and Jay R. Lieberman, MD, a member of the NQF's VTE Prevention and Care Steering Committee, represented the American Academy of Orthopedic Surgeons to the NQF.
According to sources, the proposed measures are based on ACCP guidelines developed from prospective, randomized, controlled trial data. But many common VTE practices in orthopedics are based on data from lower-grade trials. And therein lies the conflict: “Some of the orthopedic literature that is most helpful is not from randomized, prospective trials,” Pellegrini told Orthopedics Today.
Aspirin recommended against
The most contentious area recommended against involves aspirin use, which many orthopedists choose as their main prophylaxis method, said Pellegrini. The data really do not specifically support using aspirin except in conjunction with regional epidural or spinal anesthesia — not general anesthesia — nor even in conjunction with pneumatic compression devices, Pellegrini said. The candidate consensus standards also recommend against using compression stockings alone or combined with aspirin after elective THA unless there is a documented risk for increased bleeding. Data show pneumatic compression does decrease the risk of calf DVT, but increases the risk of post-THA thigh DVT.
And surgeons who use warfarin may be in a controversial position, too. The guidelines state that warfarin should be used at an International Normalized Ratio (INR) of 2 to 3. Most orthopedists do use an INR of 2 — not exactly in line with the measures. “Loosely interpreted, it may fall under the acceptable category, because an INR of 2 is the low end of what they say is acceptable. But it depends on whether surgeons usually use warfarin at [an INR] of 1.8 or 2.2,” Pellegrini said.
Bratzler noted that the performance measures do allow mechanical forms of prophylaxis, such as graduated compression stockings or intermittent pneumatic compression, both alone or in combination with any other modality for both hip and knee arthroplasty. However, the surgeon must document “any” concern with increased bleeding risk.
“The measures do not specify what the nature of the bleeding risk has to be,” Bratzler said. “As long as the surgeons document their concern, they do not have to use pharmacologic prophylaxis.”
Using an alternative VTE protocol outside the purview of the measures could place practitioners in a precarious medico-legal situation should a thromboembolic event occur — particularly without alternative guidelines or a position statement endorsed by the orthopedic community, according to Pellegrini and Lotke.
“There needs to be organized a workgroup to come up with some guidelines, constructed by a group that is predominantly orthopedic surgeons in addition to other medical specialists. But [orthopedic] surgeons need to be better represented than ... on the ACCP panel because our concern is to counterbalance the risk of bleeding that occurs with using some of the stronger anticoagulants,” Pellegrini said. “The discussion really is about balancing the risk of pulmonary embolism and fatal pulmonary embolism, if not treated, versus the risk of bleeding directly related to the anticoagulant treatment or prophylaxis.”
Some subspecialty societies, including the Hip Society and the Knee Society, have begun an effort to provide some recommendations to the AAOS. But Pellegrini said it will require a larger movement to mitigate the ACCP recommendations, such as an National Institutes of Health consensus conference. “I would be more confident that such a group’s recommendations would be given the appropriate weight to moderate the ACCP guidelines and give orthopedists a leg to stand on,” he said.
Editors note: Sanofi-Aventis, which markets the low-molecular-weight heparin Lovenox/Clexane, funded the NQF VTE consensus standards project through an unrestricted grant.