LCD Reference Article Response To Comments Article

Response to Comments: Lower Esophageal Magnetic Sphincter Augmentation

A59759

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A59759
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Article Title
Response to Comments: Lower Esophageal Magnetic Sphincter Augmentation
Article Type
Response to Comments
Original Effective Date
05/30/2024
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The comment period for the Lower Esophageal Magnetic Sphincter Augmentation DL39780 Local Coverage Determination (LCD) began on 02/15/24 and ended on 03/30/24. The notice period for L39780 begins on 05/30/24 and will become effective on 07/14/24.

Response To Comments

Number Comment Response
1

It is with enthusiasm and expectation I write this letter in support of coverage for patients requiring and opting for Lower Esophageal Sphincter Magnetic Augmentation as part of their complicated GERD management. For background I hold position of Associate Professor and Chief of Thoracic & Foregut Surgery. We cover an area of over 20 counties, urban and rural, and over 1 million population total. I will keep it simple and avoid quoting all the medical published peer review data supporting each one of the following statements to convey and justify the need to maintain the safer cost-effective coverage for MS:

-Allows patients to avoid surgical fundoplication (Nissen, Toupet, etc.) surgeries plagued with complications, poor long-term outcomes, and high rates of returning to medical need for antiacids (PPI's, H blockers etc.)

-Allows sparring of the gastric anatomy avoiding functional issues and complications for patients

-MSA has higher rates of keeping patient's symptoms AND PPI us free in prospective randomized data.

-MSA is economically viable paying for itself in the middle run just in overall PPIs use cost avoidance over time.

-MSA avoids manipulation of the stomach, sparring its fundus and blood supply, hence maintaining patient's options should they evolve to cancers and other conditions that NEED a normal stomach for their treatment.

-MSA is the only FDA approved antireflux intervention as an ALTERNATIVE to medical therapy, and not just for complicated GERD. Hence patients that wish to avoid PPI or H blocker use, as well as those who cannot due to osteoporosis, dementia risk, renal disease, or other interactions have an option for treatment.

-MSA shows improved longer outcomes in preliminary data for small and large hiatal hernias.

-MSA is the only FDA approved antireflux option for restoring GEJ valve function in patients that have undergone bariatric sleeve gastroplasty for GERD treatment in these complicated patients that frequently cannot progress to a Roux-Y gastric bypass.

-MSA represents a safer and more cost-effective option FDA approved for management of the sleeve gastroplasty associated GERD. In the era of bariatric surgery where hundreds of thousands of these interventions are done yearly in the USA, the economic impact of a less costly safer intervention cannot be understated.

-MSA is the only antireflux option for restoring GEJ valve function in patients that have undergone benign peptic ulcer disease, bariatric or cancer interventions (sleeve gastroplasty, Bilroth I and II, or Roux-Y reconstructions)

-MSA gives patients an option to save their stomach from resection when fundoplications (Nissen, Toupet, etc.) frequently fail requiring re- intervention

-MSA allows for simpler surveillance and management of Barrett's esophagus by not altering and angulating the esophageal anatomy

-MSA is a different intervention than esophageal fundoplications (Nissen, Toupet, etc. It should be considered as such.

-MSA avoids the malabsorptive, blood supply, and internal heria complications of Roux-Y gastric bypass, and hence should be preferred in appropriate patient selection for complicated reflux management.

-Roux-Y esophagojejunostomy and gastrojejunostomy for end stage complicated GERD disease remains an extremely difficult process for insurance approval.

-MSA offers a more definitive solution for rural patients with less regular access to medical and specialist GI care in the rural communities, necessary when medical chronic PPI/H blocker management is chosen instead.

-MSA needs to remain an option for high volume academic centers as ours, where treatment of complicated disease processes falls off the classic "community cookie cutter" model of indications.

We do not make these assertions lightly and maintain an academic and critical approach to our patients care as a tertiary referral center. The Thoracic & Foregut Division follows in risk assessed national databases as the STS Database, outcomes and long-term results of our interventions. We participate in peer reviewed trials an scrutinize our data. We publish industry free trials in high impact peer review media, as well as keep a finger on the industry pulse in regard to changes. It is then with this complete and frankly, concerned for our patients' options, that we hope MSA remains an option they have access to. Please do not hesitate to contact us with questions or concerns.

Palmetto GBA thanks you for your comments and support of this 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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