As the deadline approaches to submit comments, we are resending this e-mail for the benefit of those who may not have seen it. If you have already responded, thank you.
CMS has proposed an extension of Coverage with Evidence Development (CED) and the introduction of new requirements for coverage for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis. The recently completed CMS-approved study (MiDAS ENCORE) fulfilled the original requirements for CED as stated in the Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis (CAG-00433N).
The results of this study and the existing body of literature clearly establish mild® as reasonable and medically necessary. Efficacy and safety are comparable or exceed currently covered surgical, interventional, and conservative therapies. As such, unrestricted coverage without the need for additional studies under CED should be granted. We therefore respectfully request that you change your draft coverage policy on PILD to a final coverage policy that grants full coverage for the mild® procedure without the requirement of doing another study. Not reversing this illogical and inappropriate decision is deleterious to patient access and investment in innovations.
Here is our draft comment letter to Tamara Syrek Jensen, JD, Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services, on the Proposed Decision Memorandum for Percutaneous Image-guided Lumbar Decompression (PILD). The attached letter details our opposition to the proposed extension of Coverage with Evidence Development (CED) and the new requirement for coverage.
We need your support on this measure and we need to move quickly ahead of the upcoming comment period deadline. Please look over the letter and let us know if you would like to support this letter by having your name added.
For your name to be included, please send your name and those who are willing to sign on, including titles, as well as your city and state to Kasi Stunson at [email protected] by October 2 at 5:00 pm CST.
Thanks,
Laxmaiah Manchikanti, MD
Chairman of the Board and Chief Executive Officer, ASIPP and SIPMS
Medical Director, Pain Management Center of Paducah
Clinical Professor, Anesthesiology and Perioperative Medicine
University of Louisville
, Kentucky
2831 Lone Oak Road
Paducah
, KY 42003
Phone: 270-554-8373 ext. 101
Aaron K. Calodney, MD
President, ASIPP
Director of Clinical Research
Precision Spine Care
Texas
Spine and Joint Hospital
PO Box
130459
Tyler
TX 75713-0459
Phone: 903-531-2500
