CMS: Arthroscopic lavage, some debridement for knee osteoarthritis not covered
A group of orthopedic surgeons plans to voice its concern about the decision.
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The Centers for Medicare and Medicaid intends to issue a national noncoverage determination for arthroscopic lavage for patients with knee osteoarthritis, as well as for arthroscopic debridement for patients with knee pain only or with severe cases of osteoarthritis, according to a decision memo released July 3. “All other indications of debridement for patients with osteoarthritis of the knee will remain at contractor discretion,” the memo stated.
No effective date has been set.
Severe knee osteoarthritis (OA) was defined in the memo as Outerbridge classification III or IV, which is fragmentation or fissuring in an area >1 cm or cartilage erosion down to the bone, respectively.
The CMS decision comes after several months of reviewing clinical data pertaining to arthroscopic surgery as treatment for patients with knee OA, including the controversial study on the subject by Moseley et al published last July in the New England Journal of Medicine.
180 days to NCD
Prior to modifying current policies or putting any new ones into effect, CMS said it intended to issue documents providing specific directions to its claims-processing contractors about executing the guidelines outlined in the decision. Those documents, such as a program memorandum, CMS ruling or Federal Register Notice, will include an effective date and that will form the National Coverage Determination (NCD), the memo stated. The NCD will then be published in the Medicare Coverage Issues Manual.
In a telephone interview with Orthopedics Today, William W. Tipton, MD, director of medical affairs for the American Academy of Orthopaedic Surgeons (AAOS) said, “What we’re going to emphasize to our members is that what was released on July 3 is a national coverage analysis. There will be 180 days until the actual NCD is printed. Not that it’s open for public comment any more, but we do have an opportunity to share our concerns.”
Representatives of the AAOS, the Arthroscopy Association of North America (AANA), the American Orthopaedic Society for Sports Medicine, the American Association of Hip and Knee Surgeons and the Knee Society have worked with CMS during its coverage policy review, meeting with them in November and January to provide input for the decision.
Preparing a unified response
That same group met by teleconference July 8 and is crafting a memo to CMS about its response to the decision. According to Tipton, after representatives from all five groups have the chance to make suggestions, “it will be made public and sent to CMS as step one.”
The memo is expected to state the group’s agreement with two key aspects of the analysis, both of which correspond with what they presented to CMS last December in a report entitled, “Arthroscopic Surgery and Osteoarthritis of the Knee.”
“One is that lavage alone is not indicated in the osteoarthritic knee. We don’t have a problem with that. And second, debridement is not indicated in those OA patients with knee pain only. We’re comfortable with both of those,” Tipton said.
Two concerns
Concerns center on using the Outerbridge classification to determine which patients have severe knee OA and the final sentence in the decision summary, where coverage for treatment of patients in certain subgroups would be left to contractor discretion.
“The Outerbridge classification is an arthroscopic classification, which means they have to scope the patient to be able to classify them,” Tipton said. Instead, the group plans to recommend that a radiographic classification be used.
Because the decision’s last sentence is vague, the orthopedic group will ask for clarification because different carriers’ interpretations of it could lead to inconsistencies in coverage.
“The development of guidelines for contractors will be a topic of conversation with CMS,” Tipton said. “We would want physician involvement in the process of guideline development.”
The group plans to request another meeting with CMS, possibly in September, to discuss their concerns and recommendations in person. An offer to educate AAOS members about the NCD will also be made, Tipton said.
Alan H. Morris, MD, of St. Louis, who worked with the group during its communications with CMS, said in a telephone interview the contractor discretion sentence neither supports nor contradicts the fact that there is a subpopulation in which the surgery is effective. “Because there are several articles that support that position, CMS is saying … that coverage would continue for arthroscopic surgery debridement in OA in that certain subpopulation with appropriate mechanical symptoms and indications.”
But, he said, steps should be taken to ensure the language is appropriate and clear. “What we don’t want to have happen is that based upon this coverage policy an orthopedic surgeon does an operation on a patient with OA with appropriate indications, and payment for his procedure is denied because of the carrier’s misinterpretation of this coverage policy. That’s how it’s going to affect the individual orthopedic surgeon,” said Morris, an Orthopedics Today, editorial board member.
Wake-up call
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Orthopedics Today, Chief Medical Editor Douglas W. Jackson, MD, who testified before CMS on the subject Jan. 30, put the decision in perspective: “CMS establishing indications for a surgical procedure based on its willingness to reimburse is a wake- up call for our professional organizations, putting them in a defensive rather than proactive position. Ideally, surgical indications should be based on outcomes studies and evidence-based data that is peer reviewed.
“This type of clinical research is improving and currently being carried out for certain conditions, but it will take years to have more definitive conclusions for many current practices. These studies must be well-designed, have reproducible results, consider different subsets of populations and involve several surgeons at multiple centers.”
In a telephone interview with Orthopedics Today, J. Bruce Moseley, MD, lead author of the study which prompted CMS to evaluate its coverage policies for arthroscopic treatment of knee OA, said he had mixed feelings about the decision. “I think we need some guidelines for when and how to do arthroscopic surgery. So, in that regard, I think this is a positive step. But, on the other hand, I’m really disappointed these aren’t guidelines that are being hammered out and decided on by the doctors themselves. … It’s getting to the point that we’re basically letting the insurer decide what they’re willing to pay for.”
He said the fact that evidence-based medicine is not currently being practiced is part of the problem and called for more specifics in the CMS decision about when arthroscopic surgery is indicated. “My opinion is there is no true scientific data right now to say that it’s ever indicated. If you take our study as being accurate, and I think it is, we did not find any exceptions to our conclusions that it’s all a placebo effect. If they want to find a reason to do arthroscopy for an arthritic knee, then they need to do a study and prove that is actually the case.”
Moseley said he responded to CMS in early July to point out some problems with its decision. He recommended convening a group of interested and concerned orthopedic surgeons, including AAOS and AANA representatives, to work out some of the problems with the decision and its guidelines. “I’d be surprised if we changed their mind and quite honestly, I think they’re probably right. But, I would rather that the surgeons had come to that conclusion themselves.”
For more information:
- The CMS Web site containing the national coverage analysis for arthroscopy for knee OA is http://www.cms.gov/ncdr/trackingsheet.asp?id=7.