LCD Reference Article Response To Comments Article

Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF)

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A58195
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Article Title
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF)
Article Type
Response to Comments
Original Effective Date
05/28/2020
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The following are the comment summaries and contractor responses for the Novitas Solutions Proposed Local Coverage Determination (LCD) DL35130 Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF) which was posted for comment on December 26, 2019 and presented at the Open Meeting on January 16, 2020. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number Comment Response
1

The commenter states the indications in the proposed policy are beyond confusing and asks what does “including periosteal infiltration with one of the following” refer to, the non-hospitalized patient alone or both the hospitalized and non-hospitalized? What is pedicle periosteal infiltration? The references seem to indicate it is a sham procedure. Is Novitas saying a patient must undergo sham injection and fail before undergoing the procedure? Which patients require the “multidisciplinary team consensus” – the patient with severe impact only since the “and” follows that? Just the stable patients? Every patient? What does the close parenthesis refer to after “Neurologist”? It seems to be there doing nothing. I would suggest formatting this in a standard format for a hierarchy with appropriate indentation and not this mix of numbers and bullet dots that simply confuses everything. Here is the Wikipedia page if you need guidance. Link to Wikipedia provided.

The commenter asks why a radiologist is required to be part of the decision-making team if they are not the performing provider. Radiologists read the MRI and that is all. Commenter does not think it is standard of care to consult neurology if neurosurgery is already on the case. That is based on the European guideline where there is a single statement about “patient selection” that is not based on any evidence but merely the way it is done in Europe. There is no medical necessity for consulting neurology and that is a key tenet on CMS guidelines.

The commenter disagrees with multidisciplinary team consensus requirement. Commenter states this is not the standard of care. Commenter states we are requiring consultations that are not medically necessary and questions “why a neurologist?” Commenter also states we are asking a radiologist who reads an image to comment on the medical necessity of a procedure they never do unless they are performing the procedure itself.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to remove the sham periosteal injection requirement.

2

Multiple comments received indicating there is no literature evidence for the time of the fracture treatment, the requirement for periosteal infiltration or the requirement for multidisciplinary consensus. Multiple commenters provided the same suggested wording and changes in the indications and limitations sections.

Multiple commenters state the new LCD is not what was discussed and is not based on solid evidence. The new LCD will limit the number of patients that receive treatment with vertebral augmentation. The difference now is that we now know it is almost certain to increase mortality.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The sham and periosteal requirement has been removed.

3

The commenter states PVA or VCF is valuable in cancer patients and oncologists frequently refer for this process. The commenter requests that oncology be added to the list of members on the team. The commenter requests the deletion of the requirement that the patients need to be hospitalized for pain control as many oncologists try to keep cancer patients out of the hospital. The commenter indicates this procedure has been performed on outpatients many times with any complications.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The patient does not require hospitalization, and can be treated in a non-hospitalized setting provided the criteria outlined in the policy are met.

4

The commenter agrees with the acute coverage only, recommends the deletion of the requirement of a neurologist on the multidisciplinary team and to change the relative contraindication of “coagulopathy” to “uncorrected coagulopathy” to remove any ambiguity.

We appreciate your comment. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The relative contraindication term of coagulopathy has been amended to uncorrected coagulopathy.

5

The commenter disagrees with only covering acute fractures and the requirement of multidisciplinary consensus. The commenter states the contraindication in >3 vertebral fractures is too broad and vague as it does not specify age, treated or untreated. There is no guidance for fractures >6 weeks with continued edema on MRI “acute on chronic”, no guidance for the treatment of cancer patients and no guidance for those patients with sacral insufficiency fractures.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The scope of the policy is related to thoracolumbar fractures and does not include discussion of sacral fractures.

The contraindication of greater than three vertebral fractures will remain in the policy.

6

The commenter disagrees with the multidisciplinary consensus requirement and feels restricting access to the procedure is a disservice to patients.

We appreciate your comment. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

7

The commenter disagrees with the proposed changes and feels these changes will be limiting access. The commenter also disagrees with requiring the patient go through a sham injection to prove where and if the pain generator is the spinal fracture. The commenter requests Novitas not make access more difficult.

We appreciate your comment. After consideration, the policy has been amended to remove the sham and periosteal injection requirement.

8

Multiple commenters indicate procedures should be offered to symptomatic patients in both the acute and subacute phases with supporting documents and imaging. Omitting subacute fractures would be an additional measure of restricting care for a patient and subjecting them to increased mortality/morbidity. Optimal non-surgical management requiring a pedicle injection that penetrates the periosteum should be removed from the language as it is unnecessary and offers no sustainable value. The commenters disagree with making 3 points of deformity a requirement and disagree with requiring multispecialty consensus which further delays patient care.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the sham and periosteal injection requirement.

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The contraindication of greater than three vertebral fractures will remain in the policy.

9

The commenter indicates that performing a sham procedure will only prolong pain and delay treatment. The commenter further indicates having a neurology consult is not necessary and adds no benefit to the patient and again delays treatment.

We appreciate your comment. After consideration, the policy has been amended to remove the sham and periosteal injection requirement.

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

10

The proposed multi-specialty approach will absolutely delay care and prevent patients from undergoing a low risk and high reward procedure. The recommendation that a neurologist evaluate these patients is absurd. It is highly unreasonable for a patient in acute pain wait for any period of time. This procedure reduces inpatient stay and emergency department visits. Patients who undergo kyphoplasty have much improved quality of life with significantly reduced narcotic use. Requesting not to reduce access.

We appreciate your comment. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

11

Multiple commenters disagree with limiting access, requiring the sham procedure of periosteal injection and requiring multi-specialty consensus. The commenters feel this is a disservice to the patients.

We appreciate your comments. After consideration, the policy has been amended to remove the sham and periosteal injection requirement.

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

12

Multiple commenters indicate neurology opinions are not relevant to kyphoplasty procedures and disagree with the 6 week limitation. The commenters indicate the time limitation is not clinically valid as many fractures take longer to heal and incomplete healing is specifically noted on MRI. Additionally, placing a time limit on tumor patient’s treatment would be harmful to the patients.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

13

Multiple commenters disagree with the multidisciplinary consensus requiring a neurologist. Including a neurologist in the decision making process may lead to wrong treatment decisions, delays in care and added expenses. The commenter states the guidelines deter providers from offering VA and lead to more opioid use. In today’s society, clinically proven opioid sparing interventions should be facilitated not obstructed from the patient. The commenters also disagree with requiring a sham procedure.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to remove the sham and periosteal injection requirement.

14

The commenter indicates the proposed measures are burdensome, delay care, involve physicians (neurologists) unfamiliar with these treatments and will significantly increase costs, suffering and deaths. The added complexity as proposed will impede and delay the management of patients.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the sham and periosteal injection requirement.

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

15

The commenter disagrees with the requirement for a multidisciplinary team consensus – the reference to “neurologist” should be replaced with “neurosurgeon, orthopedic surgeon or neurologist”. It is unclear why radiologist is included here. If the radiology report is expected to reflect the acute changes referenced in the Covered Conditions then the appropriate statement should be added to the coverage criteria. However, a separate opinion from a radiologist should not be needed. The coverage criteria implies that providers who perform PVA would be expected to develop their own multidisciplinary team to review cases on a regular basis. This appears to be an overly burdensome requirement that would negatively affect patient access to care.

The Group1/Group 2 CPT codes included are reported for Percutaneous Vertebral Augmentation when performed for any condition. Thus, the diagnosis codes listed may not be considered the only covered diagnosis codes for Percutaneous Vertebral Augmentation. It would be inappropriate for systematic billing edits to be implemented that would deny/reject percutaneous vertebral augmentation claims for diagnoses other than those listed. Therefore, in the interest of clarity, the commenter strongly recommends the diagnosis codes be removed from the guidelines.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The diagnosis codes included in the article should be broad enough to cover patients who require this treatment.

16

The commenters have concerns with the exclusion of treatment for fractures over six weeks old and the requirement of a multidisciplinary team. The commenters proposed revisions to covered indications and exclusion criteria. The commenters indicate that limiting this procedure to fractures <6 weeks old will have a negative impact on patient outcomes and the providers’ ability to provide evidence-based and appropriate spine care to our patients. The commenters believe the multidisciplinary requirement is not established in the literature and will lead to increased costs and delays in patient care. The commenters recommend removing the reference to the Roland Morris Disability Questionnaire as multiple valid tools that demonstrate functional disability exist. The commenters also recommend using exclusion criteria that further stratify the degree of contraindication to allow for a more individualized approach to treatment in unusual circumstances. The relative contraindication regarding fracture retropulsion needs to be modified to include “with neurologic compromise”. The commenters do not believe the literature supports periosteal infiltration as a required treatment prior to vertebral augmentation.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to remove the sham and periosteal injection requirement.

The Roland Morris Disability Questionnaire (RDQE) will remain in the policy to provide a mechanism to quantify documentation of the impact on daily functioning.

17

The commenter disagrees with the treatment timeframe and multidisciplinary consensus requirement.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

18

The commenter disagrees with the inclusion criteria limiting access for subacute fractures. The commenter disagrees with the periosteal infiltration requirement, the multidisciplinary team consensus and exclusion criteria listing absolute contraindications. The commenter recommends adopting the multidisciplinary expert group using the RAND/UCLA appropriateness criteria methodology.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the sham and periosteal injection requirement.

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

19

The commenter disagrees with the inclusion criteria eliminating subacute fractures, periosteal infiltration to be performed prior to augmentation procedure, multidisciplinary team which requires approval by four physicians, one of them a neurologist, and rapid access to emergency equipment. The commenter would like emergency equipment defined.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the rapid access to emergency equipment requirement.

The policy has been amended to remove the sham and periosteal injection requirement.

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

20

Multiple commenters indicate the proposed indication of “Osteolytic vertebral metastasis or myeloma with severe back pain related to a destruction of the vertebral body, not involving the major part of the cortical bone that meet the criteria listed” needs clarification on what defines major part. The commenter disagrees with the removal of coverage for subacute fractures and coverage for acute or acute on chronic fractures less than 6 weeks old, the use of periosteal infiltration and the multidisciplinary consensus.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to include both acute (<6 wks) and subacute (6-12 wks) fractures.

The policy has been amended to remove the sham and periosteal injection requirement.

21

The commenter states the timeline for fracture treatment needs to be changed to acute and subacute fractures and the multidisciplinary team consensus point needs to be eliminated.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

22

The commenter requests clarification – the commenter asks:

  • “Is this policy in relation to the current policy that addresses all types of compression fractures or will there be an additional Billing and Coding Article under this LCD, such as has been finalized by Noridian, to still address PVA for indications other than those osteoporotic/malignant in nature?”
  • “If the future LCD/LCA replaces the current one, does this mean all unaddressed indications outside of osteoporotic or malignant compression fractures are still covered?”
  • “In regards to the multidisciplinary team consensus, does this mean every patient must see a neurologist? We would not expect the patient to be referred to a neurologist unless it is medically necessary, however it appears that all of the physicians listed under multidisciplinary team must have consensus.
  • “What documentation would Novitas expect to see if the multidisciplinary team has consensus?”

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The scope of this policy is related to thoracolumbar osteoporotic fractures and the second subsection is related to malignant fractures.

23

Multiple commenters disagree with the requirement of treatment time of 6 weeks or less with no option of treating subacute fractures post 6 weeks, limiting the number of fractures treated to three, and the multidisciplinary consensus requirement.

The commenters suggest clarifying treatment timeline, inclusion criteria for non-hospitalized patients, and the multidisciplinary team consensus should be clarified as follows:

  • The treatment recommendation alone is adequate for treatment as long as it comes from a multidisciplinary team but is not required for treatment as a multidisciplinary team is most often not available.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

Greater than three vertebral fractures will remain as a contraindication.

24

The commenter requests the addition of the following ICD-10 codes: S22.000A wedge compression fracture of unspecified thoracic vertebra, initial encounter for closed fracture, S22008A other fracture of unspecified thoracic vertebra, initial encounter for closed fracture, S32.000A wedge compression fracture of unspecified lumbar vertebra, initial encounter for closed fracture, S32.008A other fracture of unspecified lumbar vertebra, initial encounter for closed fracture, S22.008D other fracture of unspecified thoracic vertebra, subsequent encounter for fracture with routine healing, S32.010A wedge compression fracture of first lumbar vertebra, initial encounter for closed fracture.

We appreciate your comment, after consideration, the codes on the current policy should be sufficient enough to support medical necessity of the procedure.

25

Multiple commenters request clarification of the timeline to treat. Is the intent to cover fractures treated accurately (less than 6 weeks) as well as fractures older than 6 weeks but in which a patient continues to exhibit acute symptoms (thus the acute on chronic)? Or only less than 6 weeks? The commenters disagree with not covering subacute fractures, periosteal infiltration of the pedicle, multidisciplinary team consensus, non-coverage of sacroplasty, and no more than 3 fractures. The commenters recommend that for the inclusion of cancer related fractures to include a separate section to address cancer related fracture patients and their criteria be based on verbiage from previous policies as well as including payable diagnosis codes for cancer related fractures.

The commenters recommend the verbiage for no more than 3 fractures be changed to “no more than three vertebral fractures in a single treatment session.”

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks) and has removed the sham and periosteal injection requirement.

Greater than three vertebral fractures will remain as a contraindication.

The policy has been amended to remove the sham and periosteal injection requirement.

The scope of the policy is related to thoracolumbar fractures and does not include discussion of sacral fractures.

26

The commenter states serial CT scans weeks apart or serial CT scans with strong history indicating a fracture is new, requiring an MRI to confirm the obvious would be wasting resources. If acuity is in question an MRI or bone scan is necessary; however, this is not always the case. Further if a patient cannot have an MRI we are going to be wasting resources and delay care by ordering a needless bone scan. The commenter agrees nearly everyone does require a bone scan or MRI, putting absolute criteria like this delays care for the small percentage of patients whom serial imaging suffices. Additionally, it often takes longer than 30 days to see a specialist, especially with HMO plans. The commenter disagrees with the proposed change of >25% vertebral body height loss and requirement for multidisciplinary team consensus.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The proposed >25% vertebral body height loss will remain in the policy.

27

Multiple commenters disagree with the fracture timeline of <6 weeks duration and excludes coverage for fractures that are >6 weeks old. The commenters state this is not supported by medical literature or relevant specialty societies. The commenters recommend the removal of the reference to pedicle periosteal infiltration as this should not be a precondition for surgery. The commenter further recommends removal of the multispecialty team consensus requirement as this poses potentially serious delays in treatment.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the sham and periosteal injection requirement.

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

28

The commenter disagrees with the proposed timing of imaging/length of time since the fracture. The commenter does not agree that a defined age of the imaging should be of primary importance. Rather, it should be a part of the clinical decision making. The commenter disagrees with the proposed multidisciplinary consensus. There is no reason to include multiple physicians. Radiologists do not necessarily have any meaningful understanding of treating vertebral fractures. Neurologists have absolutely no mandated training in compression fractures and may not even know what a kyphoplasty is. The proposed guidelines create an insurmountable obstacle for the patient, which provides no added benefit for the patient.

We appreciate your comments. After consideration, the policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

29

The commenter disagrees with the timeframe, limiting to acute or acute on chronic fractures and excluding coverage for subacute fractures. The commenter disagrees with the multidisciplinary consensus to include a neurologist. The commenter disagrees with limiting the clinical questionnaire to the Roland Morris Disability Questionnaire when there are a number of other validated clinical instruments that have been used in clinical investigations. The commenter indicates it seems inappropriate to apply similar guidelines for osteolytic vertebral metastasis as those listed for osteoporotic vertebral compression fractures. Painful osteolytic have various multiple and complex pain generators that can result in severe and intermittent pain that treatment for their primary cancer may limit their ability to be treated within 6 weeks. Additionally, due to tumor related osteolysis can result in circulating neurostimulating cytokines these lesions can be extremely painful without limited, if any collapse, and certainly less than 25% the current proposed requirement.

We appreciate your comments. After consideration, the policy has been amended to include both acute (<6 wks) and subacute fractures (6-12 wks).

The policy has been amended to remove the “neurologist” and the “multidisciplinary team consensus” requirements to reduce the provider burden upon both the referring physician and treating physician. We encourage providers to refer patients presenting with vertebral compression fractures for evaluation of bone mineral density in addition to taking part in an osteoporosis prevention and treatment program.

The Roland Morris Disability Questionnaire (RDQE) will remain in the policy to provide a mechanism to quantify documentation of the impact on daily functioning.

The proposed >25% vertebral body height loss will remain in the policy.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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