Well...just as I was writing, this came through my email in response to my message to WPS:
Mr. Smith,
Thank you for your inquiry regarding L38213 Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) with a future effective date of 12/16/2019. The comment period for DL38213 was open 05/30/2019 through 07/14/2019.
The Local Coverage Determinations (LCDs) are written by the Medicare Administrative Contractors (MACs). MACs have the discretion to develop, revise or retire LCDs and Articles within their jurisdictions. WPS GHA adheres to IOM 100-08, Medicare Program Integrity Manual, Chapter 13, Local Coverage Determinations and guidance provided by CMS for the General LCD Process Overview. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c13.pdf
L38213 Coverage Indications states:
- Multidisciplinary team consensus (2) (ALL are required):
- Referring physician (e.g., rheumatologist, endocrinologist)
- Treating physician (i.e., performing the PVA)
- Radiologist
- Neurologist
Bibliography
- Tsoumakidou G, Too CW, Koch G, et al. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol. 2017;40(3):331-342.
A multidisciplinary team consisting of a radiologist, a neurologist, a spine surgeon and referring physician (rheumatologist, endocrinologist or oncologist) should come to a consensus which patients should undergo this procedure and they should ensure appropriate adjuvant therapy and the follow-up.
A detailed clinical history and examination with emphasis on neurological signs and symptoms should be performed to confirm that the VCF is the cause of debilitating back pain and to rule out other causes, like degenerative spondylosis, radiculopathy and neurological compromise. The typical patient suffering from VCF has midline non-radiating back pain that increases with weight bearing and manual palpation of the spinous process of the involved vertebra [21]. The clinical signs and symptoms should always be correlated with the imaging findings [1, 32]. In osteoporosis and metastatic disease, multiple fractures may be present; not all of the fractures necessarily require treatment.
The Local Coverage Determination (LCD) Reconsideration process is a method by which interested parties can request a revision to an active LCD. Information on the changes to the LCD reconsideration process can be found in Change Request (CR) 10901 .
The reconsideration process is only available for Final LCDs that are in effect. The entire LCD or any part of it is subject to reconsideration.
Sincerely,
Ryan Holzmacher, M.D.
J5 Contractor Medical Director, Medicare
Ann Everson RN
Policy Development Coordinator
Wisconsin Physicians Service Government Health Administrators
So, it would seem that they're sticking to their guns. It still isn't clear to me how they would determine compliance with this.
Dave
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David Smith FACMPE
Executive Director
United Imaging Consultants
Mission KS
(785) 393-8387
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Original Message:
Sent: 12-12-2019 15:00
From: David Smith
Subject: New CMS Requirement for Vertebroplasty/Kyphoplasty
You're welcome. BTW, I have traded some emails with Judi Buckalew at SIR Government Relations on this, and I believe they're working on the issue. I also sent an email to WPS myself.
Thanks for pointing it out!
Dave
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David Smith FACMPE
Executive Director
United Imaging Consultants
Mission KS
(785) 393-8387
Original Message:
Sent: 12-12-2019 14:56
From: Maegan Moore
Subject: New CMS Requirement for Vertebroplasty/Kyphoplasty
Thank you! This is very helpful information.
------------------------------
Maegan Moore
Director, Marketing & Physician Relations
Synergy Radiology Associates
an affiliate of MEDNAX
Houston, TX
Past President
Texas RBMA
Original Message:
Sent: 12-09-2019 17:53
From: David Smith
Subject: New CMS Requirement for Vertebroplasty/Kyphoplasty
Maegan
Since this is an LCD, it's coming from the individual MAC (in this case WPS), not CMS. Interestingly, I can see a proposed version DL38213 (which was apparently the version people commented on), that stated the requirement significantly differently:
------------
Inclusion criteria (ALL are required):
- Acute* (< 6 weeks) osteoporotic VCF (T5 – L5) by recent (within 30 days) advanced imaging (bone marrow edema on MRI or bone-scan/SPECT/CT uptake) (1-3,10,25)
- Symptomatic (ONE):
- Hospitalized with severe pain (Numeric Rating Scale (NRS) or Visual Analog Scale (VAS) pain score ≥ 8) (4-7)
- Non-hospitalized with moderate to severe pain (NRS or VAS ≥5) despite optimal non-surgical management (NSM) (10)** (ONE):
- Worsening pain
- Stable to improved pain (but NRS or VAS still ≥5) (with ≥ 2 of the following):
- Progression of vertebral body height loss
- > 25% vertebral body height reduction
- Kyphotic deformity
- Severe impact of VCF on daily functioning (Roland Morris Disability Questionnaire (RDQ) >17)
- Multidisciplinary team consensus (referring physician (e.g., rheumatologist, endocrinologist), treating physician (i.e., performing the PVA), radiologist, neurologist) (2)
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You can also see the comments at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=57631&ver=2&LCDId=38213&bc=AAAAAAABAAAA&
The change doesn't really seem to relate to any of the comments, so it's not clear why it was made. This might be a good topic to engage SIR or ACR on, or your IR docs could reach out to the MAC Medical Director.
Short of asking for records, it isn't clear to me how WPS would know whether a neuro consult was done.
------------------------------
David Smith FACMPE
Executive Director
United Imaging Consultants
Mission KS
(785) 393-8387
Original Message:
Sent: 12-09-2019 16:06
From: Maegan Moore
Subject: New CMS Requirement for Vertebroplasty/Kyphoplasty
Good Afternoon All,
Has anyone else seen the latest CMS requirement for Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) (L38213)? It looks like it is stating that as of 12/16/19, all PVAs (Vertebroplasty/Kyphoplasty), must have a Neurology consult. Does this sound accurate to everyone? Does anyone know if a neurosurgery or ER consult would suffice, given this terminology? Seems that this could be very impactful to outpatient IR consults coming from non-neuro referring physicians.
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38213
Thanks,
------------------------------
Maegan Moore
Director, Marketing & Physician Relations
Synergy Radiology Associates
an affiliate of MEDNAX
Houston, TX
Past President
Texas RBMA
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