Medicare Part B local coverage determination (LCD) comment summary

LCD Number

22533

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

Lumbar Spinal Fusion for Instability and Degenerative Disc Conditions

AMA CPT Copyright Statement

CPT codes, descriptions, and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

Start Date of Comment Period:

06/03/2011

End Date of Comment Period:

07/18/2011

Comments received:

Comment #1: There were numerous comments from beneficiaries and some physicians expressing concerns that First Coast J-9 MAC may be limiting the Medicare benefit for lumbar spinal fusion surgery for Medicare beneficiaries.

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.   Lumbar spinal fusion 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: Several comments were received on the effectiveness that lumbar fusion has had on family members, or on themselves, and some of the comments suggested good outcomes from a minimally invasive procedure.

Contractor response: The goal of lumbar spinal fusion, also referred to as lumbar arthrodesis, is to permanently immobilize the spinal column vertebrae surrounding the disc(s) that are causing the discogenic low back pain.  Surgical techniques to achieve lumbar spinal fusion are numerous, and include different surgical approaches (anterior, posterior, lateral) to the spine, different areas of fusion (intervertebral body (interbody), transverse process (posterolateral)), different fusion materials (bone graft and/or metal instrumentation), and a variety of ancillary techniques to augment fusion.  The presacral interbody technique is noted in a separate LCD, titled Noncovered Services, and, therefore, is not a covered service in A/B MAC J9. However, this LCD, Lumbar Spinal Fusion for Instability and Degenerative Disc Conditions, does not address lumbar spinal fusion techniques, devices, instrumentation, or bone graft substitutes.  Some of the emerging techniques and associated tools (devices, spinal instrumentation, bone graft substitutes, etc.) are investigational, and this policy does not endorse such noncovered procedures. The scope of this LCD is the indications and medical need of Lumbar Spinal Fusion for instability and degenerative disc conditions. 

Comment #3: Numerous comments were received that included the following statements: The LCD represents very limited choices for other spinal surgeries and fusions; some people may still need to have back surgery to improve their quality of life because pain medication and physical therapy won’t necessarily alleviate all of the pain; Medicare appears to be like other insurance that will not pay for needed spinal conditions; this LCD will eliminate Medicare coverage for multi-level lumbar fusion for DDD as well as decompression discectomy without spondylolisthesis and should be revised or not be finalized. .

Contractor response: It is not the intent of the LCD to deny necessary spinal surgery.  The final revised LCD addresses some of these concerns with clarifications in the indications and limitation sections and an explanation added to the documentation requirements.

Medicare Administrative Contractors develop LCDs based on the strongest evidence available. The extent and quality of supporting evidence is key to a good policy, and the LCD development process ensures that there is adequate opportunity for interested stakeholders to supplement this evidence by submitting new information (hierarchy of evidence from physician input & expert opinion up to randomized controlled clinical trials published in peer reviewed medical journals) and/or by submitting suggested wording changes to the LCD.   The information in the public domain on lumbar spinal fusion is both complicated (large amount of literature and not always well categorized) and complex (multiple stakeholders all with some inherent bias).  When information in the public domain is not compelling (evidence insufficient) in support of a procedure/service for a given condition, the Contractor must balance the impacts of non coverage with the provision of access to care for the Medicare beneficiary who frequency has comorbidities.  As noted in the Contractor Response to comment #1, this LCD addresses the physician’s responsibility to document the indications and medical need for lumbar spinal fusion.  It emphasizes the opportunity for the physician to address the medical need (in the pre service documentation) for a given patient if the coverage criteria are an issue.  At the claim level, any denied services have appeal rights.   At the LCD (policy) level, any final LCD can be revised based on the LCD reconsideration process outlined on our website at http://www.fcso.com.

Comment #4: There is concern that the American Academy of Orthopedic Surgeons (AAOS), American Association of Neurological Surgeons/Congress of Neurosurgeons, and the Neurological Association need to have input in developing this LCD.

Contractor response: This draft LCD was presented to our “Contractor Advisory Committees which include representatives from numerous societies, including Orthopedics and Neurosurgery. In addition, comments with rationales and literature from specialty organizations have been submitted and reviewed and revisions to the LCD have been made based on comments and literature, which include comments from the National Association of Spinal Surgery (NASS), The International Society for the Advancement of Spine Surgery (ISASS) and the American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS) as well as other local societies. LCDs are developed to address various issues such as access to care or a validated widespread problem, and are based on the strongest evidence (e.g. peer reviewed literature) available.  This development process is not new and has been in place for many years (over a decade).  LCDs are developed three times per year and the policy process includes the development of drafts by the policy staff after research of peer reviewed literature in the public domain as well as input from the Contractor Advisory Committee (CAC) members that include the various specialty groups prescribed by the Centers for Medicare and Medicaid Services (CMS). When a draft LCD is posted, that starts a 45 day comment period that includes an open public meeting and discussion of the draft policies at the closed CAC meeting (in Orlando and San Juan, PR).  Any interested stakeholder can give input on a draft policy during the comment period (medical.policy@fcso.com), and we especially encourage the submission of the evidence based literature to support any revision recommendations.  After a draft LCD becomes effective/active, any stakeholder may request a revision to the policy, by following the reconsideration process as outlined on our website.

Comment #5: Under the “Limitations” section of the LCD, the following language needs to be added for the conditions listed as not considered medically necessary and are noncovered: “except in a situation where the space is unstable.” The physician’s judgment should not be taken away.

Contractor response: The revised finalized LCD incorporates this concern. .

Comment #6: Several comments were received concerning the requirement for cognitive therapy prior to surgery for the condition of spinal instability or degenerative disc disease (DDD) not being appropriate and reasonable. Cognitive therapy is valuable for those afflicted with chronic pain syndrome or concomitant psychological disease. For patients with mechanical and neurologic complaints, standard medical therapies are quite effective and surgery also has a high success rate. Also, cognitive therapy would not have a role for treatment such as fibromyalgia. It is recommended this section of the LCD should be reworded.

Contractor response: The final LCD notes, “If cognitive, behavioral, or addiction issues are identified, the documentation should support assessment and treatment prior to surgical management.” Therefore, the responsibility of such assessment and treatment is based on the physician’s pre-surgical evaluation and non-surgical medical management. Of note, the evidence based literature clearly supports such interventions. Recommendation #2 of the evidenced based clinical guideline (Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain from the American Pain Society) notes:

In patients with nonradicular low back pain who do not respond to usual, noninterdisciplinary interventions, it is recommended that clinicians consider intensive interdisciplinary rehabilitation with a cognitive/behavioral

emphasis (strong recommendation, high-quality evidence). Chronic back pain is a complex condition that involves

biologic, psychological, and environmental factors. For patients with persistent and disabling back pain

despite recommended noninterdisciplinary therapies, clinicians should counsel patients about interdisciplinary

rehabilitation (defined as an integrated intervention with rehabilitation plus a psychological and/or social/

occupational component) as a treatment option.

Comment # 7: Comments were received stating this LCD will compromise the surgeon’s ability to provide patients with the best care available and will increase the frequency of repeat surgery and ultimately increase the cost rather than decrease it. Surgeons must have all options available to provide seniors with the best care available without subjecting them to not having a successful outcome. This LCD is not in the best interest of the patients.

Proposed changes in Medicare for lumbar fusion procedures are not the best medical practice, but are driven by industry analysts for the purpose of denying coverage and saving money. There is no data to support they improve outcome of lumbar fusion surgery and limits the physician’s ability to treat patients. It may cause physicians to withdraw from Medicare if kept from practicing and providing the best care for patients by unreasonable, unscientific, and unfair government mandates.

Contractor response: Refer to Contractor response #1 above regarding the goal of this of this LCD. Also, refer to Contractor response to #s 3 & 4 above regarding the LCD development process and evidence. Low back pain in the role of spinal fusion is a complex subject (large volume of peer reviewed literature and not well categorized, and multiple stakeholders such as, patients, physicians, providers, device manufacturers etc). The final LCD has been revised based on stakeholder input. As with any LCD, this LCD gives physicians the opportunity to support their decision making.

Comment # 8: Verbiage should be added to the LCD stating that if on review of the inpatient claim there is insufficient evidence for coverage, services for both the hospital and physician services will be denied.

Contractor response: J9 MAC agrees that if the documentation is insufficient to support that the inpatient claim meets the threshold of reasonable and necessary services, the physician’s services could also be denied. (assuming the same documentation was submitted to support the physician services).

Comment # 9: A comment was received in support of this LCD because frequently patients with back pain and spine pathology inappropriately undergo overly aggressive surgery without the benefit of utilization criteria based on outcomes registries. This LCD covers lumbar spinal fusion only when select rarely present criteria are met, and to no longer globally cover multi-level lumbar fusion of symptomatic degenerative disc disease. A certain segment of orthopaedic and neurosurgeons who do back surgery in Florida have taken advantage of a carte blanche attitude and approach to back pain management. Most spine surgeons who are competent, caring and have only their patient’s best interest in mind will not be affected by this LCD and continue to provide high quality multimodal care for back pain.

Contractor response: J9 MAC appreciates the support of this LCD. Our goal, as noted in Contractor response in #1 above, is to cover medically reasonable and necessary services by including indications and limitations of coverage and documentation requirements. Also, CMS has addressed some concerns with their National Medicare Coverage Committee in 2006, and draft technology assessment by the Agency for Healthcare Research and Quality (AHRQ) entitled, “Spinal Fusion for Treatment of Degenerative Disease Affecting the Lumbar Spine.” It is hoped that this draft will be finalized with a more current assessment of published data.

Comment # 10: A comment was received stating while inclusive of many indications for fusion, the LCD ignores key diseases that necessitate fusion such as disc collapse with foraminal stenosis, and severe foraminal stenosis requiring resection of greater than 50% of the facet.

· In the setting of severe disc collapse, the foramen can be compressed causing neurologic pain and dysfunction. When refractory to nonoperative management, the proper surgical solution is restoring the disc height and thus foraminal height. The only way to perform this is to perform an interbody fusion. Thus, object ion is made to this proposed LCD in its current form as it is incomplete and would harm patients. One scenario which would be denied under this proposal is a patient presenting with the above condition, leg pain, a foot drop or weakness. Patients would wrongly be denied the proper surgery, and only authorized a decompression procedure which would be doomed to fail. Please reconsider your proposal to include interbody fusion for the above condition

· In the setting of severe facet arthropathy, the foramen can be so compressed as to require resection of greater than 50% of the facet to adequately decompress the foramen. Without fusing the segment, the patient is doomed to segmental instability and a decompression alone would lead to failure of the procedure. The proposed policy would wrongly deny the patient the proper surgery, and only authorize a decompression procedure which would be doomed to fail. Please reconsider your proposal to include fusion for the above condition.

Contractor response: The final revised LCD incorporates some of these concerns. J9 MAC welcomes any supporting documentation to address indications that do not appear to be addressed in this LCD. After a draft LCD becomes effective/active, any stakeholder may request a revision to the policy, by following the reconsideration process as outlined on our website.

Comment # 11: Comments were received stating the restrictions proposed in this draft LCD are discriminatory and will result in limited access to care and appropriate treatment for thousands of Medicare beneficiaries. Many patients suffer from multilevel lumbar stenosis and performing fusion only at one level would subject the patient to returning after 6-12 months to have additional surgery performed. Decompression (laminectomy) and concurrent stabilization (spinal fusion) often avoids a second surgery. Repeat spinal surgery entails increased risks to the patient, higher costs, and generally poor results in the end. Requiring 6 to 12 months of conservative management prior to consideration of fusion can result in severe financial hardship.

The criteria listed in # 4 for degenerative disc disease includes 6 consecutive months of physician supervised physical therapy and cognitive therapy. Conservative measures such as cognitive and physical therapy cannot provide long term relief for patients. Co-payments for physical therapy may be out of reach for many patients, particularly those on limited incomes. I am not aware that cognitive therapy has any bearing on the results of a spinal condition.

Several comments included concerns regarding the draft LCD prohibiting surgery from being performed on patients who smoke. It is not fair or appropriate to discriminate against one group of patients based on their smoking alone. This in itself should not deny multi-level lumbar fusion.

There is no awareness that the committee making these determinations included anyone representing organized neurosurgery or orthopedic spinal surgery. It appears this draft LCD allows for local discriminatory power to be placed in the hands of a committee when allocating resources for a national healthcare program.

The references in the LCD are misleading and unsupportive and suggest NASS agrees with the draft LCD when there is no such conclusion. Review of the cited articles found no direct comparison of active treatment to an untreated control group.

Contractor response: Refer to Contractor response #1 above regarding the goal of this LCD. Also, refer to Contractor response to #s 3 & 4 above regarding the LCD development process and evidence. The finalized LCD has been revised and incorporates some of these concerns in regard to the documentation of conservative therapy (non-surgical medical management). The peered reviewed literature does not consistently support multi-level (2 levels or more) spinal fusion for DDD, and in fact it is not recommended for elderly patients by some experts in the field. The physician has opportunity to make his/her case for the specific indication for two level or the rare three or more level spinal fusion for DDD. The case specific indications for the two level or the rare three or more level planned fusion procedure must be directly addressed in the pre-procedure record with clinical correlation to diagnostic testing results.

Comment # 12: A comment was received stating while many of the indications in Milliman are sound, they serve to treat a limited minority of pathologies and not the majority of the etiologies related to pain and dysfunction for which patients seek and receive surgical care. Furthermore, these guidelines were devised without regional or global consideration of spinal motion segment function (the 2 “limitations” in the LCD), which the entire spinal community now considers as the standard (arguably making the proposed draft LCD guidelines marginally relevant or, at best, case specific.) Spinal surgery guidelines can only be made with significant input from contemporary, practicing spinal surgeons. In addition, references in the draft LCD do not provide sufficient scientific evidence to support the indications and limitations of coverage for DDD. There is a departure from standard of care and the LCD should not be adopted. We would be happy to discuss and participate in establishing algorithms based on best practices and an analysis of current clinical evidence.

Contractor response: See Contractor response to #s1 & 3 above for the goals and evidence of this LCD. The finalized LCD has been revised and incorporates many of these concerns. After a draft LCD becomes effective/active, any stakeholder may request a revision to the policy by following the reconsideration process as outlined on our website.

Of note, the current Medicare regulatory guidance in review of documentation in support of hospital claims includes the current use of screening tools and clinical judgment. The current screening tools used by Medicare Contractors throughout the country are usually Milliman and InterQual. Therefore, such screening criteria are already being utilized regardless of an LCD.

Comment # 13: Numerous comments were received regarding the need of multi-level fusion and literature summaries and references were submitted. One comment stated thousands of Medicare patients in Florida will be denied access to spinal surgery procedures that have been established standards of care for many years. There are several situations where a multi-level fusion of the spine is indicated in the degenerative spine (i.e. Lumbar stenosis with scoliosis, lumbar stenosis with multilevel spondylolisthesis, 2-3 level degenerative disc disease to name a few). There are no double blinded randomized studies to say that multilevel fusions do not work. Peer related articles can be flawed in study design and make-up with many bias. The Milliman criteria have not been approved by any spine surgery society or academic spine centers. This LCD will cost Medicare more money in the future. The 2-3 level fusion currently being performed in one sitting will now take place with 2-3 separate surgeries. There is not one spine surgeon on your current committee to discuss the draft proposal, this is inexcusable.

Contractor response: This draft LCD was presented to our “Contractor Advisory Committee” which includes representatives from numerous societies, including Orthopedics and Neurosurgery. Refer to Contractor response #s 3 & 4 above regarding the LCD development process and evidence. See Contractor response #11 above regarding multi-level DDD.

Comment # 14: Comments were received from the North American Spine Society (NASS), Neurosurgery group practice, and others with multiple suggestions/rationales for revising the draft LCD in various sections which are bulleted below. The Contractor responses will be given under each individual bullet below:

Under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD:

· The statement “Lumbar fusion of more than two segments (single level), is not typically recommended except in some situations such as trauma or for neoplasm” is an outdated understanding of the benefits of lumbar spinal fusion. Multilevel spinal fusion has become a well established surgical technique and is well described in the spine surgery literature for a variety of indications beyond trauma and neoplasm.

Contractor response: Refer to Contractor response # 3 regarding LCD evidence approach. The revised finalized LCD incorporates some of these concerns.

Under # 1 of the “Indications” section of the LCD:

· “Epidural abscess” should be added to the list of indications as this condition frequently results in neurological compromise from neural compression that requires removal of boney elements that can result in instability, thus requiring fusion and stabilization.

· The term “acute spinal fracture does not include acute ligamentous instability without fracture and should be changed to “acute spinal injury, with or without neurological deficit.”

· If may be appropriate to add “degenerative dynamic instability,” which can be defined as gross change in anteroposterior alignment as noted on flexion and extension views, to the list in the this section. This can occur without spinal stenosis spondylolisthesis as noted on an MRI or CT (these studies are obtained in a supine position and dynamic instability is elicited when a patient is standing.)

Contractor response: J-9 MAC agrees that lumbar spinal instability would include epidural compression or vertebral destruction from tumor or abscess. Therefore, the final revised LCD includes this indication. When the LCD becomes effective/active after the 45-day notice period, any stakeholder may request a change to the LCD by following the LCD Reconsideration process as outlined on our web site. We will be happy to review any supporting literature for fusion of acute ligamentous instability without fracture and/or supporting literature for degenerative dynamic instability as an indication for spinal fusion when submitted with a formal reconsideration request.

Under # 2 of the “Indications” section of the LCD:

· Prefer the term “nonoperative treatment” instead of “3 months of conservative treatment’ except in cases with a progressive neurological deficit, such as a new-onset foot drop.

· The requirement of at least 4mm of anterior translation to be sufficient for the diagnosis of spondylolisthesis is not a clinically appropriate parameter and is not rooted in any clinical studies to our knowledge. The majority of modern spine surgery literature uses a grading system based on the percentage of vertebral body translation. Some patients have a diagnosis of retrolisthesis or rotational-listhesis. The absolute measurement of mm of spondylolisthesis has not been defined as an important prognostic factor or decision-making variable. The grade of slippage is more commonly used. The majority of degenerative spondylolisthesis patients with stenosis are Grade I slips, defined as less than or equal to 25% of the anteroposterior diameter of the superior endplate the lower vertebra. Strongly suggest changing the radiographic requirement to “Radiographic evidence of at least a Grade I slip at the level of stenosis.” A diagnosis of grade one or greater spondylolisthesis (anterio, retro, or rotational) is widely used and more appropriate indication for lumbar spinal fusion.

Contractor response: Verbiage in the LCD will be revised to define conservative therapy as “non-surgical medical management. In addition, language will be revised to include “or other documented evidence of instability (e.g. facet joint instability (iatrogenic) related to decompression) with listed criteria.

There is supporting literature that the Meyerding’s Grading System is commonly used by clinicians to measure the degrees of slippage in spondylolisthesis with grades I and II slips considered stable and grades III and higher slips as unstable. Therefore, the language in the LCD will be revised to include radiographic evidence described in classification of grade slips.

Under #3 of the “Indications” section of the LCD:

· The time requirement of 6 to 12 months of conservative treatment for symptomatic low-grade spondylolisthesis is unnecessarily long. Recommend changing the interval to 3 to 6 months for this indication, which would allow earlier access to surgical treatment in a patient population that clearly benefits from surgical intervention. One source suggested to delete the words “after at least 6-12 months of conservative treatment” in the 4^th bullet of this section.

· The criterion “Neurologic compromise symptomatic high-grade spondylolisthesis demonstrated on plain x-rays” is confusing. There are 2 distinct patient types that can fall in this category. One is the patient who is asymptomatic but has a high grade (more than 50% slippage) that poses a significant and impending risk of neurological compromise. This patient is reasonably offered a lumbar fusion. The second type is the patient with a high-grade slip who has frank neurological compromise and is symptomatic, who clearly should be offered a fusion and decompression. Another comment stated the diagnosis of neurologic compromise symptomatic high-grade spondylolisthesis may be made on CT imaging as well. Therefore, the criteria should read “demonstrated on plain X-rays or CT imaging.”

Contractor response: There is conflicting information about the time requirement for conservative therapy for spondylolysis. Since some sources recommend fewer months of conservative treatment, the language in the LCD in this section has been revised to incorporate this concern. In addition, language in the LCD has been revised for clarification regarding the other concerns.

Under # 4 of the “Indications” section of the LCD:

· The LCD is appropriately stringent and selective. It was suggested that the reference of 6 consecutive months of non-surgical management in this section be changed to 3 months. In addition, seeking smoking cessation to proceed with surgery is a reasonable goal. However, requiring such cessation is unnecessarily burdensome. Recommend to delete the smoking cessation requirement from the LCD. Another comment requested to change language in the LCD to read “The patient is a nonsmoker, or has been advised to refrain from smoking for at least 6 weeks prior to surgery and 6 months after surgery.”

Contractor response: The final LCD has been revised to incorporate some of these concerns regarding conservative therapy (non-surgical medical management.

Under # 5 of the “Indications” section of the LCD:

· The requirement of at least 4mm of anterior translation is not rooted in clinical data. Any degree of anterolisthesis present after surgery that was not present before surgery should be considered a sign of instability. It is recommended to remove 4 mm criteria and replace with grade one spondylolisthesis in this section of the LCD. Also, any evidence of dynamic instability is also considered postoperative instability. Retro- and rotational-listhesis are possible diagnoses for associated spondylolisthesis.

· In addition, it is recommended to remove “Failure of at least 3 months conservative management” for lumbar fusion following prior spinal surgery under the 7^th bullet in this section.

Contractor response: Language in this section of the LCD has been revised to state “Instability is documented by appropriate imaging.” The final revised LCD notes “clinically appropriate,” so an exception to 3 months of non-surgical medical management can be addressed in the documentation.

Under # 6 of the “Indications” section of the LCD:

· The requirements for fusion for treatment of pseudoarthrosis appear to be reasonable. However there are some circumstances in which pseudoarthrosis can lead to hardware failure and potential irreversible bone loss or neurological risks that make waiting 12 months imprudent. In such situations, we feel that revision surgery for a pseudoarthrosis should be considered acceptable 6 months after index surgery. In the absence of these specific situations, 12 months is a reasonable time interval for revision fusion surgery. Another comment requested the 12 month requirement for treatment of psuedoarthrosis be removed as well as the 3 month requirement of failed conservative management in this section.

Contractor response: Documentation requirements in the LCD will specify that if a patient does not meet all the required criteria outlined I the LCD for a procedure, but the treating physician feels that the procedure is a covered procedure given the current standards of care, then the docuemnttion must clearly outline the patient’s episode of care that supports the major procedure and must clearly address the reason(s) for coverage. Any requested revisions may be addressed through the reconsideration process.

Under the “Limitations” section of the LCD:

· There is strong agreement with the LCD that fusion should not be performed in the vast majority of cases of primary laminectomy or discectomy for stenosis or disc herniations without spondylolisthesis. There are rare exceptions – cases of foraminal stenosis or disc herniations, adequate decompression often necessitates aggressive removal of a facet joint. This can lead to iatrogenic instability that would best be treated by fusion at the time of the index surgery.

· It is wholeheartedly agreed that fusion for multi-level degenerative disc disease (DDD) should not be covered.

Contractor response: Refer to last contractor response above regarding documentation requirements in the LCD.

Comment # 15: Several comments were received from The American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS), and AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves, and others with suggestions/rationales for revising the draft LCD. The following suggestions for revising various sections of the LCD are given below with the Contractor responses given under each individual bullet:

Under # 2 of the “Indications” section of the LCD for spinal stenosis with associated spondylolisthesis for a single level, when ALL criteria are met:

· There is concern about the need to meet “all” relevant criteria offered in the LCD as this may generate denials of coverage in patients where operative intervention is appropriate, requiring appeals that may delay appropriate patient care. Example is a patient with dynamic instability arising from a spondylolisthesis may not manifest stenosis on radiographic imaging, but may have severe symptoms due to degenerative spinal instability. It is felt that “all of the following” in this section be changed to “the following pertinent criteria are met.” In addition, a suggestion was made to remove the word “ALL” and replace with “ANY” in this section of the LCD as well as remove the requirement for 3 months conservative medical management.

Contractor response: Language in the LCD has been revised to include “other documented evidence of instability” and the “ALL” criteria will be revised to incorporate clinically appropriate exceptions.

Under # 4 of the “Indications” section of the LCD for DDD in the absence of instability when ALL criteria have been met:

· There is concern regarding mandating that “all” of these criteria be met by every patient in this section. While the incidence of depression in chronic pain patients is quite high, requiring psychiatric or neuropsychological evaluation of all patients with low back pain may not be appropriate. Use of nicotine increases the risk of wound complications and decreases incidence of bone healing after spine surgery. However, nicotine use is generally not considered an absolute contraindication to spine surgery procedures. It is recommended to edit the LCD to read “when the following pertinent criteria are met” in this section.

Contractor response: J-9 MAC agrees that “ALL” criteria may not be valid for each patient. Therefore, language in this section of the LCD has been revised to state “clinically appropriate for the patient’s current episode of care.” This would include treatment prior to surgical management if cognitive, behavioral, or addiction issues are identified. In addition, regarding patients who smoke, counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted have been added.

Under the “Limitations” section of the LCD for conditions not considered medically necessary and noncovered:

· Surgical treatment of lumbar stenosis or lumbar disc herniations may generate iatrogenic instability. With foraminal or extraforaminal disc herniations, a total resection of the involved lumbar facet joint may be required to identify and remove the herniated disc fragment and to decompress the involved nerve root. In cases where a greater than 50% facet resection is required to achieve decompression of neural elements, a spinal stabilization may be required. The LCD should allow for spinal stabilization procedures in cases where iatrogenic instability is anticipated.

· Limiting the LCD to only single level lumbar DDD is questioned. Numerous studies have attested to the potential benefit of two level fusions for lumbar DDD as treatment for carefully selected patients with disabling low-back pain due to one- or two-level degenerative disease without stenosis or spondylolisthesis. Based on spine surgery literature that demonstrates excellent clinical outcomes can be achieved in select patients with 2-level fusion procedures, and recommended guidelines by specialty societies, it is recommended the LCD not restrict surgical treatment of lumbar DDD to a single level.

· A suggestion was made to eliminate the verbiage “for a single level” limitation or in the alternative, change the language to “for one or two levels;” and another suggestion was to change the limitation to “when performed with greater than two-level DDD.”

Another suggestion was made to add “unless stenosis is also associated with a spinal deformity or treatment requires wide decompression or facetectomy that may result in iatrogenic lumbar instability” under # 1 of the “Limitations” section of the LCD.

Contractor response: The final revised LCD has incorporated most of these concerns.

· It is suggested that this draft LCD be postponed for immediate implementation to allow a meeting of interested parties to further discuss concerns and suggestions. Even though this draft LCD was posted on the website in early June and discussed at a CAC meeting, most neurosurgeons were completely unaware of this proposal until recently and would welcome the opportunity to meet directly with FCSO J-9 MAC and other appropriate representatives to discuss the implementation of a final LCD in more detail.

Contractor response: This LCD has been finalized after review of submitted literature, comments, and input from numerous specialty societies. After the 45 days notice period, any interested stakeholder can request an LCD reconsideration. Refer to Contractor response # 3 above for FCSO J9-MAC website.

Comment # 16: Comments were received stating the following with Contractor response under each bullet below:

· There are times when performing a laminectomy that the surgeon may feel a fusion is required due to instability developing during the procedure. In such instances, fusion should be allowed if the physician feels it is medically necessary to ensure stability.

Contractor response: The final revised “Limitations” section of the LCD incorporates this concern.

· The indication of treatment of cancer should be included for lumbar spinal fusion.

Contractor response: The third paragraph of the LCD includes the situation such as neoplasm as an indication for lumbar fusion of more than a single level. Cancer alone would not be a covered diagnosis without documentation of spinal instability.

· There are concerns with the requirement of at least 3 months conservative care for spinal stenosis. If the neurologic compromise becomes profound with possible bowel or bladder loss or compromise of lower extremity function, flexibility to provide medically necessary care is needed.

Contractor response: The final revised LCD incorporates this concern.

· Six to twelve months of conservative treatment for symptomatic low grade spondylolisthesis may be difficult to comply given the limitations of therapy benefits available to Medicare beneficiaries.

Contractor response: J-9 MAC agrees conservative treatment may be different for individual patients. Therefore, language in the LCD has been revised to incorporate this concern.

· Discography as a provocative concordant adjunct test, after all other treatments have failed, should remain an option if medically necessary.

Contractor response: The LCD does not prohibit needed diagnostic testing but states imaging studies or radiographic evidence for some indications. Of note, the evidence based literature is not compelling in regard to discography.

Comment # 17: The following comments were received from a Health Care representative and physicians for the draft LCD with explanations of why the draft needs to be modified with Contractor response under each category section below:

· Under the “Limitations” section that states “When performed with initial primary laminectomy/discectomy for nerve root decompression or spinal stenosis, without documented spondylolisthesis” the LCD fails to consider the instance when a patient’s decompression surgery would result in instability, making a fusion surgery necessary. The LCD also fails to consider coverage when there are signs of instability such as synovial cysts and facet joint widening.

· Under the “Limitations” section that states “When performed with multiple-level (i.e., >1 level) DDD” this draft LCD fails to acknowledge the need for two level fusions including patients who have no other option for treatment of their chronic low back pain when other treatments have failed. While literature on surgical treatment of lumbar DDD remains controversial, the highest quality prospective and controlled randomized study of surgery for lumbar DDD showed clear benefits in operatively treated patients.

· Data on 2 level DDD surgery is currently under consideration by the FDA as part of an investigational device exemption (IDE). This data indicated significant improvement from 2 level DDD surgery. Therefore, the non-coverage of 2 level DDD surgery in the LCD would be premature against best medical evidence in 2011.

Contractor response: The “Limitations” section of the final LCD has been revised and addresses these concerns.

· Under the “Indications” section of the LCD, spondylolisthesis is defined as being 4mm of anterior translation only. This definition eliminates the consideration of retrolisthesis as indicator of instability. Within the spinal community, 2mm of listhesis is considered physiological. Beyond 2mm is considered abnormal (not 4mm). If a measurement is applied to define listhesis, it should be >3mm in any direction (anteriolisthesis, retrolisthesis, or lateral listhesis). The failure to consider instability in any other plane other than anterior is a significant oversight in this draft LCD.

Contractor response: The final revised LCD incorporates this concern.

· The LCD fails to consider the instance when a patient’s decompression surgery would result in instability, making a fusion surgery necessary. Denying the surgeon’s intra-operative judgment will result in delayed care for patients and increased cost to the healthcare system. Ultimately, the patient would require a second procedure to correct the instability that could have been corrected during the initial surgery.

Contractor response: The “Limitations” section of the final LCD has been revised and addresses these concerns.

· The AANS and CNS are beginning a prospective accrual of outcomes data in a variety of spine surgery patients, including lumbar degenerative disease undergoing operative therapy. Spine SCOAP is starting as an implementation of the Swedish Spine Registry as a multilateral collaborative between spine surgeons, hospitals, third part insurers and patients. AO Spine N.A. has initiated an unprecedented patient safety initiative through a series of multicenter studies aimed at improving real time data recording of leading academic spine centers throughout North America. Implementation of the proposed LCD may therefore be premature.

Contractor response: Refer to Contractor response #s 1, 3, & 4 above. This LCD was developed as a result of errors found by the Comprehensive Error Rate Testing (CERT) when reviewing inpatient hospital claims for lumbar spinal fusion surgery. Any requested revisions may be addressed through the reconsideration process.

Comment # 18: Comments were received stating this draft LCD will be more expensive, result in more drug dependent elderly and repeat surgery. Medicare has tried to go more toward double blinded/evidence based medicine indications to support treatment modalities. However, spine industry and specialists are reticent to pursue or participate in such studies due to differencing pathologies, neurological deficits, and motivation which make it nearly impossible to obtain adequate comparable patient populations in adequate numbers despite the number of spinal fusions performed each year. This draft LCD is unrealistic about costs, literature, available treatments, and the true goal and success rate of spinal fusion in the diverse disease that it is.

If you cover only procedures that are supported by literature then it would be more helpful to fund research to look at the “indications” for fusion or put together a panel of spinal surgeons and nonoperative clinicians to come up with a consensus regarding the appropriate use of fusion surgery. The criteria in this LCD do not accurately reflect all of the appropriate indications for a surgical fusion of the spine and would put the physician in a position of having to defend the decision to perform a fusion.

Contractor response: Refer to Contractor response #1 above regarding the goal of this LCD. Also, refer to Contractor response to #s 3 & 4 above regarding the LCD development process and evidence. This LCD was developed as a result of errors found by the Comprehensive Error Rate Testing (CERT) when reviewing inpatient hospital claims for lumbar spinal fusion surgery. Any requested revisions may be addressed through the reconsideration process.

Comment # 19: Comments were received with disagreement of the “Limitations” section as well as some prior sections of the LCD. FCSO is taking a “one size fits all” approach to patient care and removing the traditional physician patient relationship for the equation. The following examples were given in contradiction of the limitations in the LCD:

· Initial primary laminectomy for the patient requiring a “far lateral” discectomy for intractable radiculopathy can occasionally result in destabilizing the segment due to the need for complete facetecomy in order to achieve adequate decompression of the affected nerve root. The limitation in the LCD removes the pre-operatively and intraoperatively decision for discectomy, possible fusion from the patient and physician.

· Defining “instability” with a specific measurement of anteriolisthesis ignores total translation from posterior to anterior on flexion/extension films as well as specific patient parameters. For example, a 250lb disabled laborer who translates with 3mm retrolisthesis to 3mm anteriolisthesis has a total of 6mm of instability yet would fit into the limitations cited for noncoverage.

· Determining noncoverage for anything other than 1 level DDD ignores the extensive experience of practicing spine surgeons and published literature. The disabled laborer noted above who meets all listed criteria including a positive discogram at L4-5 and L5-S1 is a candidate for 2-level fusion. Also the patient who as >4mm degenerative spondylolisthesis at one level and a positive discogram at an adjacent level with radiographic DDD. Another comment stated multilevel lumbar fusion for DDD would be reasonable for a patient with radiographic evidence of moderate to severe DDD at L3-4, L4-5, and L5-S1 who is referred for a discogram. During the discogram, the patient reports sever e concordant pain during injection at L3-4. This patient may reasonably consider L4-5 and L5-S1 lumbar fusion because there is clinical evidence of pain generation at two segments.

· Degeneration of multiple motion segments can lead to coronal as well as sagittal plane imbalances in a subset of these patients. Patients with complex multilevel lumbar degenerative deformities frequently have significant impairment and surgery, including multilevel fusion, is a “quality of life issue” for these individuals.

Contractor response: The final revised LCD addresses many of these concerns. Any requested revisions may be addressed through the reconsideration process.

Comment # 20: The following comments were received for the “Indications” and “Limitations” sections of the LCD with Contractor response under each referenced bullet section below:

· Under # 2 of the limitations section: It is felt there are patients with spinal stenosis and spondylolisthesis with back pain, without neurologic claudication symptoms or radicular pain, who are appropriate candidates for fusion and who respond favorably to fusion. The 4mm anterior translation requirement ignores retro-listhesis and lateral-listhesis.

Contractor response: The final revised LCD has been revised and addresses these concerns.

· Under # 3 of the limitations section: Confirmed progressive deformity is unclear and seems to suggest it would not allow surgery for an otherwise appropriate candidate until radiographic studies show worsening of deformity which would create delay and poorer outcome. The requirement of 6-12 months of conservative treatment for less than grade 3 slippage will result in similar poor results.

Contractor response: Confirmed progressive deformity in section # 3 for spondylolysis is one of any of the required criteria listed in this section. It is not a standalone requirement and should be documented if indicated. The final revised LCD addresses the time requirement for non-surgical medical management.

· Under # 4 of the limitations section: Fusion for DDD can be appropriate. It is not clear what cognitive therapy includes and there are some patients who are unable to exercise due to pain. The prohibition of surgery for depression, drug or alcohol abuse, and smoking are unacceptable criteria in the LCD.

Contractor response: The final revised LCD addresses these concerns.

· Under the “Limitations” section of the LCD: The limitations for spinal fusion for primary laminectomy/discectomy for nerve root decompression or spinal stenosis, without documented spondylolisthesis, ignore proper indications for fusion including iatrogenic or undetected instability found at the time of surgery. There are appropriate cases with DDD, widened facet joints on preoperative studies, with axial back pain, that respond favorably to fusion procedures.

Contractor response: This comment has been addressed in the final revised LCD.

· Feel a 6 month extension of the comment period should be allowed so proper needed input can be obtained

Contractor response: Refer to last Contractor response in # 15 above.

Comment # 21: A comment was received stating there are no evidence-based studies for a multiplicity of spinal conditions and neurologic diseases as well as no Level I studies to support the LCD parameters to allow or deny multi-level lumbar fusions. This LCD eliminates the spine surgeons’ independence and decision-making prerogatives. The following requirements in the LCD are erroneous and potentially dangerous:

· There is no mention on post-fusion pseudoarthrosis as a cause of instability, or instability due to fractures or infections.

· The diagnosis of DDD is broad and can involve many different permutations and conditions that eliminating lumbar fusion and stabilization as a viable option would indirectly harm many patients by discarding the best option for treatment.

Contractor response: Under I of the “Indications” section of the final revised LCD, acute spinal fracture and spinal debridement for infection are listed. Under VI of the “Indications” section of the final revised LCD, pseudoarthrosis at the same level from prior surgery would be considered spinal instability. Under IV of the final revised LCD, criteria for DDD is addressed based on clinically appropriate for the current episode of care.

Comment # 22: Comments were received disagreeing with the radiographic evidence of spondylolisthesis as being 4mm of anterior translation only, as described in the indications section of the LCD. Flexion, neutral and extension radiographs are routinely used by spinal surgeons to determine motion segment instability in the sagittal plane. This definition eliminates the consideration of retrolisthesis as being a potentially important factor in determining sagittal plane instability. It is felt instability should be determined by a total of 4mm of sagittal translation, anterior, posterior or combined anterior/posterior in both one and two level pathologies.

In addition, spinal fusion should not be restricted to a single level when specific diagnostic criteria are evident. DDD is broad and includes facet joints, vertebral endplates, boney elements and soft tissues. Therefore, DDD incorrectly implies that only the disc is involved in the degenerative process when in fact the process involves biologic, structural and functional changes in the entire motion segment. Degeneration of multiple motion segments can lead to coronal as well as sagittal plane imbalances n a subset of individuals. Surgery, including multilevel fusion is a “quality of life issue.”

The following criteria for determining multilevel lumbar spine fusion should be covered:

· Severe intractable low back pain with or without neurological deficit

· Radiographic evidence of moderate to severe multilevel disc space collapse

· Radiographic evidence of significant sagittal and/or coronal plane imbalance

· Demonstration of Modic Type I inflammatory endplate changes on MRI

· Absence of psychological co-morbidities, litigation or compensation issues

· Failure to respond to 12 months of conservative therapies (unless acute or chronic functional neurological deficit develops)

Another comment stated 6 months instead of 12 months in the last bullet listed above.

Contractor response: The final revised LCD incorporates many of these concerns.

Comment # 23: A comment was received stating a difference can be made relating to the need for instrumented versus non-instrumented fusion. Instrumented fusion is much more expensive, promoted by industry, and unproven superiority over non-instrumented fusion and certainly carries more risk. Also, it is felt this LCD has for the most part no merits and a task force should be formed with prominent spine surgeons and administrators to address the issues in the LCD.

Contractor response: This LCD does not address instrumentation for fusion. The scope of this LCD is the indications and medical need of lumbar spinal fusion for instability and degenerative disc conditions. Refer to Contractor response #1 above regarding the goal of this LCD. Also, refer to Contractor response to #s 3 & 4 above regarding the LCD development process and evidence

Comment # 24: A comment was received asking what constitutes cognitive therapy , what type provider(s) can it be provided by, is there defined criteria as to what format the cognitive therapy must follow or what information must be included to be considered cognitive therapy training, and what is the frequency of the cognitive therapy within the conservative management program?

Contractor response: The need for cognitive therapy is based on the physician’s assessment and ordered treatment prior to surgical management. Depending on what is ordered, only performing providers who are trained and work in the scope of their practice should perform this therapy. Covered therapy services would fall under current Medicare guidelines which are not addressed in this LCD.

Comment # 25: Comments were received from a manufacturer outlining the following proposed changes to the LCD. In addition, references from multiple leading neurological organizations and other referenced literature were given as support of one to two fusion levels. The Contractor response is given under each referenced bullet below:

· Under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD, The motion “segment “ is comprised of two vertebrae and the intervening intervertebral disc. The description in the LCD is confusing as written and suggests that spinal conditions are typically single vertebral (boney) problems, when it is typically the joint (intervertebral disc and/or facet joints) at issue in degenerative conditions, and therefore, immobilization of the motion segment is by fusing one vertebra to the next. The comment that fusion of more than two segments is not typically recommended except in tumor and trauma is incorrect. Multi-level instability is common in the degenerative spine, where significant collapse of disc height results in foraminal stenosis and accompanying radicular symptoms, slippage results in abnormal motion as well as stenosis symptoms, and asymmetrical multi-level disc collapse leads to degenerative scoliosis with accompanying back and often radicular pain.

Contractor response: The final revised LCD incorporates some of these concerns. Any requested revisions may be addressed through the reconsideration process.

· Under the “Indications” section for # 1, for “Progressive neurological impairment” fails to include radiculopathy due to central, lateral, or foraminal stenosis due to the loss of intervertebral disc height. In this same section for “Spinal deformity,” degenerative scoliosis need not meet the 40º idiopathic definition, but need only be “progressive.” This is consistent with adult de novo degenerative scoliosis definition of more than 10º and significantly correlated with pain.

Contractor response: While all types of progressive neurological impairment are not listed in the LCD, verbiage was added to give examples of progressive neurological impairment. This is not an all inclusive list but only examples.

· Under the “Indications” section for # 4, for DDD in the absence of instability, loss of intervertebral disc height should be included. “Where these medical management options are also covered by the LCD” should be added under this section for physician supervised conservative medical management criteria.

Contractor response: The LCD is being revised to include case specific indications for multi-level fusion for DDD. In addition, verbiage is being revised to require 6 months of clinically appropriate conservative therapy for pain and significant functional impairment which includes supervised PT or unsuccessful improvement after completion of intense multidisciplinary rehabilitation (IMR).

· Under the “Indications” section for # 6, for “failure of 3 months conservative management,” recommend documented concomitant medical management of pain along the course of expected fusion, even within the 12 months following primary surgery.

Contractor response: Language in this section of the LCD has been revised to address this concern.

· Inadequate coverage decisions are being repeated by other payer policies referenced in the LCD, who are also under dispute by spine care physicians as drafted without their clinical guidance or input.

Contractor Response: Refer to Contractor response to Comment # 3 and 4 above.

Comment # 26: Comments were received with disagreements and suggestions for the following limitations in the LCD with Contractor response to specific bullets below:

· By limiting coverage to single-level fusion, the policy fails to take into account the unique anatomic and clinical realities of the degenerative, aging spine. Neither the AANS nor NASS guidelines offer recommendations about the number of levels that should be fused for patients with stenosis. The policy would eliminate coverage of two-level fusion for patients with spinal stenosis with degenerative spondylolisthesis or DDD. There are multiple clinical scenarios in which this restriction would impose barriers to medically necessary spinal fusion.

It is suggested the limitations on the number of levels fused under indications # 2 & 4, and limitation #2 be removed. It is recommended the addition of a bullet to indication #5 to indicate that fusion may be indicated for any or all levels where prior spinal surgery has been performed.

Contractor Response: Refer to Contractor response #1 above regarding the goal of this LCD. Also, refer to Contractor response to #s 3 & 4 above regarding the LCD development process and evidence. The finalized LCD has been revised and incorporates some of these concerns in regard to the documentation of conservative therapy (non-surgical medical management). The peered reviewed literature does not consistently support multi-level (2 levels or more) spinal fusion for DDD, and in fact it is not recommended for elderly patients by some experts in the field. The physician has opportunity to make his/her case for the specific indication for two level or the rare three or more level spinal fusion for DDD. The case specific indications for the two level or the rare three or more level planned fusion procedure must be directly addressed in the pre-procedure record with clinical correlation to diagnostic testing results.

· The policy does not include decompression-associated iatrogenic instability as an indication for lumbar fusion.

It is suggested that iatrogenic instability as indication for lumbar fusion in patients with spinal stenosis, and modification of limitation #1 to stipulate “without documented spondylolisthesis or iatrogenic instability” be added.

· The LCD does not reflect the spectrum of multi-planar deformity and instability that manifest in the aging spine.

It is suggested inclusion of lateral listhesis, rotary subluxation, retrolisthesis, and kyphosis (regional, global, or segmental) within indications # 1 and #2, as appropriate.

· The LCD does not adequately address the role of fusion for patients with degenerative spondylolisthesis with or without neurologic compromise or those with low-grade isthmic slips with neurologic compromise.

It is suggested that indication # 3 be modified to include degenerative spondylolisthesis in conjunction with spondylolysis/isthmic spondylolisthesis and remove “high-grade” from criterion for neurologic compromise.

· The LCD does not provide surgeons with discretion to provide timely re-intervention after failed prior surgery. Examples are a patient presenting to a surgeon at 6 months after a fusion with persistent, debilitating pain at the index level with radiographic evidence of screw loosening; and a patient with a history of metabolic disease and/or medication use affecting bone-healing metabolism may present 6 months after an initial fusion procedure with debilitating pain, as well as radiographic evidence of insufficient fusion mass at the index level. An additional 6 months of debilitating pain may not be warranted, given that the patient’s age, co morbidities, clinical presentation, and radiographic findings are suggestive of a poor prognosis.

It is suggested the bullet mandating “some relief of pain symptoms following the prior spinal surgery” be removed for indications #5 and #6. For indication # 6, it is suggested that the 12-month criterion be removed.

Contractor Response: The final revised LCD addresses many of these concerns. Any requested revisions may be addressed through the reconsideration process.

Comment # 27: A comment was received stating the section of the LCD with the heading “ICD-9 Codes that Support Medical Necessity” was incorrect since the listed codes are procedures and not diagnoses. These codes represent both open and minimally invasive approaches to the procedure.

Contractor Response: This LCD does not address the ICD-9 diagnosis codes that would be submitted for lumbar fusion in the ICD-9 procedure codes in the Part A LCD. The hospital claims system (FISS) utilizes ICD-9 procedure codes and not CPT procedure codes.

Comment # 28: A comment was received asking the following questions concerning physical therapy: Will Medicare provide a specific payment to accommodate for the physical therapy and exercise as part of the conservative medical management? Currently Medicare coverage guidelines for a supervised six-month course of outpatient physical therapy would be considered maintenance therapy and not be reasonable and necessary. Therefore, after a short course of physical therapy, the patient would be discharged and expected to exercise independently. The draft LCD states the conservative medical management, including physical therapy and exercise, be supervised by a physician. How would the physician be able to attest that the patient had complied with the conservative medical management program unless that program is supervised?

Contractor Response: The final LCD has been revised and the language clarified. 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 not require any non surgical medical management that is outside of the Medicare benefit structure.