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Medicare Part B local coverage determination (LCD) comment summary

LCD Number

27130

Contractor Name

First Coast Service Options, Inc.

Contractor Number

09102 - Florida
09202 - Puerto Rico
09302 - U.S. Virgin Islands

Contractor Type

MAC Part B

LCD Title

Major Joint Replacement (Hip and Knee)

AMA CPT Copyright Statement

Start Date of Comment Period:

06/03/2011

End Date of Comment Period:

07/18/2011

Comments received:

Comment #1: There were several comments suggesting that the intent of the draft LCD Major Joint Replacement (Hip and Knee) was to limit access to care of standard procedures and limit utilization of procedures given Medicare program cost concerns.

Contractor Response: Medicare Administrative Contractors develop medical policies, known as Local Coverage Determinations (LCDs), pertinent to their area of jurisdiction (J9 is FL, PR, USVI). The Medicare Program Integrity Manual (PIM), CMS Publication IOM 100-08, Chapter 13, gives detailed instructions on LCDs. An LCD is a decision by a Medicare contractor whether to cover a particular item or service on a contractor-wide basis in accordance with Section 1862(a)(1)(A) of the Social Security Act (i.e., a determination as to whether the item or service is reasonable and necessary). LCDs are administrative and educational tools to assist providers in submitting correct claims for payment. Major joint replacements (DRG 470) was identified as a subject for policy given the high error rate noted by the national CERT (comprehensive error rate testing) contractor after a review of sampled hospital claims for certain major procedures. The focus of this policy is to emphasize the physician's documentation responsibility in support of a major procedure. Any major procedure has significant benefit and risk (injury or death) that the treating physician discusses with the patient. To meet Medicare’s reasonable and necessary (R&N) threshold for coverage of a procedure, the physician’s documentation for the case should clearly support both the diagnostic criteria for the indication (standard test results and/or clinical findings as applicable) and the medical need (the procedure does not exceed the medical need and is at least as beneficial as existing alternatives & the procedure is furnished with accepted standards of medical practice in a setting appropriate for the patient’s medical needs and condition). Lacking compelling arguments for an exception in the supporting documentation, the hospital and physician services can be denied. So the goal of this LCD is to improve the physician documentation in support of standard major procedures and to lower claim payment error rates that are based on the review of physician documentation for a given claim.

Comment #2: Multiple comments were received suggesting that the indications for total knee arthroplasty (TKA) be revised as follows: Under the advanced joint disease heading 1.) First bullet- add “MRI showing avascular necrosis” or add “avascular necrosis” to the conditions already listed as MRI supported evidence; 2.) Second bullet- change “Disabling pain and functional disability” to “Clinically significant pain or functional disability”. Both of these conditions are valid reasons for joint replacement and only one should be required to be present to consider knee replacement medically necessary. Also in this sentence, delete “range of motion of the joint is decreased”. There are many patients such as those with valgus arthritis of the knee, avascular necrosis, or ligamentously lax individuals who have normal range of motion but still have significant disease that requires total knee replacement. The above suggested revisions are reasonable and will align with current best practices for TKA. 3.) Third bullet delete “minimum of 12 weeks” from the second sentence. Suggest revising it to read “Conservative treatment should be implemented for an adequate amount of time”. The third sentence should be revised to read “Conservative treatments should include any or all of the following”. 12 weeks of some of the conservative treatments listed may not be clinically appropriate. There is no clinical data to support this time frame for conservative therapy. Most treatments for arthritis take effect much more rapidly than 12 weeks. Anti-inflammatory medications work in less than a week, analgesics work in less than one day, PT or home exercise work within 4 weeks. Most medications will work in a few days and most exercises should have shown a benefit within 2-3 weeks. When it comes to the conservative therapy options listed in the draft LCD, not all patients will be candidates for each one. For example, anti-inflammatory medication may not be indicated for patients with a history of renal failure, heart disease, hypertension or allergy to the medications. PT may not be appropriate if the patient cannot tolerate the pain induced by the therapy. Medicare currently has a cap on PT services. If the patient is required to have 12 weeks of PT prior to a TKA, then there is concern that the patient will not have access to the required amount of PT needed after a TKA. Assistive devices cannot be used, for example, if the patient has had an amputation of the arm, has arthritis of the shoulder or hand or has a rotator cuff tear of the shoulder. Injections may not be indicated since patients have allergy or needle phobia or the patient may be at diabetic risk of hyperglycemia from the steroid. The local injection may also damage articular cartilage. The list of possible conservative treatments should not include requiring a trial of all of the requirements currently listed, but rather only require those that the patient is a candidate for. The comments submitted do support requiring documentation that shows conservative treatments were attempted or a clinical explanation as to why the patient is not a candidate for conservative therapy.

Contractor response: Thank you for the comments and suggested language. MAC J9 has revised the LCD to add “avascular necrosis” as requested. MAC J9 has taken the requested language for #2 and #3 into consideration and made revisions addressing the concerns above.

Comment #3: Multiple comments were received requesting that the indication “Malignancy of joint” under the indications for total knee arthroplasty be revised to read “Malignancy of the distal femur, proximal tibia or knee joint or adjacent soft tissues. The wording “malignancy of joint” does not adequately capture the likely clinical indications.

Contractor response: Thank you for the comment. MAC J9 has made the revision as requested.

Comment #4: Multiple comments were received requesting that the following additional indications be added to the current list of indications for TKA: 1.) avascular necrosis of the knee and 2.) proximal tibia fracture. Avascular necrosis of the knee is a fairly common disease that can result in abrupt onset of disabling pain due to arthritis from the collapse of the bone from necrosis. Older patients with a depression fracture of the tibial plateau are candidates for a TKA.

Contractor response: Thank you for the comment. MAC J9 has made the revisions as requested.

Comment #5: Multiple comments were received related to the subsection of indications for TKA titled “Replacement/Revision of TKA”. The comments ask for the following revisions: 1.) The first bullet should be revised to delete “disabling pain and functional disability” and replace it with “clinically significant pain or functional disability”. The patient should not be required to have clinically significant pain and functional disability. Each of these alone is an indication for a replacement/revision TKA. 2.) Add “dislocation of the knee joint” and “instability of the knee joint” as indications for replacement/revision TKA. Dislocation is rare but when it does happen it is an indication for replacement/revision TKA. Instability of the knee joint is the one of the most common indications for a revision TKA.

Contractor response: Thank you for the comments. MAC J9 has made revisions to this section of the LCD which addresses the concerns expressed in the comments.

Comment #6: Multiple comments were received suggesting that the indications for total hip arthroplasty (THA) be revised as follows: Under the advanced joint disease heading, 1.) First bullet add MRI showing avascular necrosis; 2.) Second bullet- change “Disabling pain and functional disability” to read “Clinically significant pain or functional disability”. Both of these are valid criteria for joint replacement and only one should be required to be present to consider THA replacement medically necessary. Also in this sentence, delete “range of motion of the joint is decreased”. Some patients have significant joint pathology (e.g., avascular necrosis) but may have preserved range of motion. 3.) Third bullet delete “minimum of 12 weeks” from the second sentence. Suggest revising it to read “Conservative treatment should be implemented for an adequate amount of time”. The third sentence should be revised to read “Conservative treatments should include any or all of the following”. The comments received do not support a minimum of 12 weeks to demonstrate failure of conservative therapy since most treatments for arthritis take affect much more rapidly than 12 weeks. One of the comments stated “conservative treatments should be implemented for a minimum of 8 weeks.

Comment #7: Multiple comments were received requesting the following revisions for the indications list for total hip arthroplasty: 1.) revise “malignancy of the joint” to read “malignancy involving the bones or soft tissues of the pelvis or proximal femur”. 2.) Third bullet-delete the word “displaced” and have it state ”fracture of the femoral neck”. In a patient with pre-existing degenerative joint disease (DJD) and non-displaced femoral neck fracture one would consider THA and that patient would have had time to fail non-operative management required for THA while treating their arthritis. 3.) Add the following additional indications for THA: a.) acetabular fracture, b.) non-union or failure of previous hip fracture surgery, c.) malunion of acetabular or proximal femur fracture. Regarding acetabular fractures, some are better managed acutely with total hip rather than attempted reconstruction of the fracture rather than exposing the patient to a second surgery to replace the hip.

Response: Thank you for the comments. MAC J9 has made the requested revisions.

Comment#8: Multiple comments were received asking that additional indications be added to the subheading for “Revision/Replacement total hip arthroplasty”. These indications are 1.) Clinically significant leg length inequality 2.) Progressive or substantial bone loss, 3.) Clinically significant squeaking and 4.) Adverse local tissue reaction. Some total hip replacements result in significant leg length inequality and require revision. Some metal on metal hips and even some non-metal hips develop significant bone loss from allergic hypersensitivity or excessive wear requiring revision. After ceramic/ceramic or metal/metal hips develop bizarre dramatic audible noises requiring revision. A patient with metallosis with soft tissue mass, even if bone loss was not dramatic but significant soft tissue masses would be a candidate for revision.

Response: Thank you for the comments. The finalized LCD has been revised and incorporates some of the recommendations.

Comment#9: Multiple comments were received requesting the following revisions to the Limitations section of the draft for total knee and total hip arthroplasty: 1.) “Active infection of the hip or knee or any other region” should be changed to read “Active infection of the hip or knee or active systemic bacteria”. Deleting the phrase “or any other region” takes into account many other chronic infections such as chronic hepatitis, chronic sinusitis that are not contraindications to total hip and total knee arthroplasty. 2.) Delete “Unhealthy skin around the hip or knee” and replace with “Active skin infection or open wound within the planned surgical site of the hip or knee replacement”. Some patients have previous scars, radiation, psoriasis, etc. that does not put the patient at increased risk, but the risk/benefit should be up to the clinician and patient as such skin conditions are often chronic. 3.) Revise “Severe vascular disease” to read “Severe vascular disease that affects the planned surgical site of the hip or knee replacement or would impede ambulation”. If there is good vascularity to the surgical site, the severe vascular disease is not a reasonable contraindication since it will not affect healing of the surgical site. 4.) Delete the limitation “Functional knee or hip implant is present (for revision total knee or hip)”.This is a duplication of the necessary indications, and are some reasons as indicated above where surgery is still indicated (previously eliminated infection, bone loss, instability, squeaking, leg length inequality, avascular necrosis, etc.) 5.) Delete the limitation “Co-morbidities that would make proceeding with surgery increase the morbidity or mortality of the patient”. Any surgical procedure results in temporary increased morbidity and most candidates for TKA/THA have several co-morbidities. Making decisions that balance the risks and benefits of any surgical procedure requires a conversation between the patient and their physician. Several commenters suggested alternative language for this limitation could state “patients who have significant medical co-morbidities that are determined by an internist or medical specialist to have unacceptably high risk of joint replacement are not candidates for TKA or THA. 5.) Delete “Past history of osteomyelitis of the hip or knee joint”. As stated under the revision/replacement subheading for TKA/THA, prior history of hip or knee infection is an indication for joint replacement, not a limitation. Several commenters suggested alternative wording for this limitation could be “Active osteomyelitis of the hip or knee joint. Active osteomyelitis is an indication for a temporary hip or knee replacement otherwise known as an antibiotic spacer”.

Response: Thank you for the comments. MAC J9 has made the requested revisions, although instead of deleting the bullet for “co-morbidities”, MAC J9 has revised that bullet to address the issue of co-morbidities being taken into consideration for non-cardiac, elective procedures.

Comment #10: A comment was received stating that the draft LCD inappropriately cites the American Academy of Orthopaedic Surgeons (AAOS) as a source for information and the basis of the draft LCD. Information found on https://orthoinfo.aaos.org does not reflect official positions of the AAOS as the disclaimer clearly states. The AAOS has not reviewed or approved the references to that site, and they should not be cited as official positions of the AAOS. The AAOS requests the citations be amended to remove the references to the AAOS. In addition, the document titled “Treatment of osteoarthritis of the knee (non-arthroplasty): Full guideline” is recognized as an official position of the AAOS, as its Board of Directors has approved this clinical practice guideline. This document is appropriately cited as an opinion of the AAOS. However, as evidenced by the title of the draft LCD, this particular practice guideline does not relate to arthroplasty. In fact, it relates specifically to treatments of osteoarthritis of the knee other than arthroplasty. The document does not specifically address TKA effectiveness or indications, and it certainly does not provide any guidance relating to hip treatments. The AAOS requests that within the LCD this be made clear in any references to AAOS’ Osteoarthritis of the Knee guideline.

Response: Thank you for the comments. MAC J9 understands the concerns expressed regarding the use of the guideline cited, “Treatment of osteoarthritis of the knee (non-arthroplasty): Full guideline” as a source of information for this LCD. However, MAC J9 feels this was used appropriately with respect to developing background information in this LCD and for addressing pathology (i.e., osteoarthritis) that could lead to the need for a TKA. The LCD does not state that this guideline established indications for performing a TKA. With regard to the other references mentioned, MAC J9 has made revisions to the references from https://orthoinfo.aaos.org and noted that these are not endorsed by the AAOS.

Comment#11: A comment was received stating that FCSO MAC J9 cover in full all the non-surgical services referenced in the draft LCD and not simultaneously limit coverage for the same non-surgical services the draft LCD suggests as alternative treatments for knee and hip conditions.

Response: As noted in response to comment #1, the goal of this LCD is to improve the physician documentation in support of a medically necessary and reasonable major hospital based procedure. Such documentation should address the indications and medical need specific to the patient’s episode of care. The peer reviewed medical literature supports that in most cases unsuccessful non- surgical medical management is a reasonable criterion to address for elective hip or knee replacement procedures. Except for the reasonable recommendations addressing home activity, exercise, life style modification, etc. that would be discussed during evaluation and management services, the final LCD does now require any non-surgical medical management that is outside of the Medicare benefit structure. The LCD allows the physician to address unsuccessful non-surgical medical management as it applies to the patient in their episode of care for significant hip or knee advanced joint disease. Also, comments noted that the physical therapy benefit has a yearly cap. Though physical therapy may not be prescribed for every patient immediately prior to hip/knee replacement, there is an exception process that can be addressed if a patient does exceed the cap in a given year based on on-going problems and/or the need for post operative therapy that require physical medicine modalities under a PT plan of care.