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The World’s Only DME Treatment for GERD

MedClineMD is the world’s first and only durable medical equipment specifically designed to treat nocturnal gastroesophageal reflux disease (GERD). MedClineMD is an FDA Class I medical device backed by peer-reviewed studies performed by the top gastroenterologists and medical institutions in the US.

Exceeding Reimbursement Requirements

MedClineMD meets CMS and private payer requirements for reimbursement.

Treatment Gap for Refractory Patients

Up to 40% of GERD patients are refractory to PPI medications, meaning they continue to experience symptoms despite daily use of anti-reflux medications.1

Increased Utilization Costs

Failure to respond to a PPI is associated with increased health-care costs, including repetitive outpatient visits, diagnostic procedures, and prescription drugs.2

Finally! A DME Solution For Treating GERD.

MedClineMD provides immediate relief of nocturnal GERD while dramatically improving health-related quality of life.

Clinical Dossier

Finally! A DME Solution For Treating GERD.

MedClineMD provides immediate relief of nocturnal GERD while dramatically improving health-related quality of life.

Clinical Dossier

MedClineMD Meets CMS DME Definitions

GERD is a chronic condition. MedClineMD was thoughtfully designed to provide immediate and life-long relief.

Download DME Dossier

Intended for long-term usage, MedClineMD exceeds the minimum lifetime requirements to be used in a patient’s home for 3-5 years. The medical-grade foam used in the primary weight-bearing components demonstrate excellent dimensional stability through extensive cycle tests utilizing the constant force pounding standardized ASTM D3574 Test I₃. All MedClineMD components are encapsulated with durable hospital-grade impermeable undercovers with the final layer of removable outer covers made of a commercial-grade fabric. Strict adherence to minimum CMS lifetime requirements ensures that MedClineMD can withstand prolonged use.

For additional durability data: DME Dossier Download

Due to a 91% patient compliance, MedClineMD items are seldom returned as they are intended for long-term patient usage. Should a product need to be returned, the MedClineMD sterilization and re-deployment process will be followed by a CMS-Accredited DME supplier. Established in 2015, the rental cycle was developed in compliance with CDC and FDA Guidelines and follows the sterilization and re-deployment process utilized with hospital mattresses and pillows.3
MedClineMD is a class I medical device listed with the FDA. Developed based on decades of positional therapy research and in accordance with AGA/ACG clinical guidelines, MedClineMD creates and maintains a clinically superior positioning method to singular modes of positional therapy. Eight clinical trials validate MedClineMD as an effective treatment for uncontrolled nocturnal symptoms, providing protection against harmful esophageal acid exposure, and improving patient quality of life without the risks, serious side effects, and high costs of anti-reflux medications and surgery. By design, MedClineMD is not useful in the absence of GERD.

For additional medical necesity data: MedCline Clinical Dossier Download

Indicated for ICD-10 codes:

K21.0 GERD w/ esophagitis
K21.9 GERD w/o esophagitis
K22.7 Barrett’s esophagus
J69.0 Aspiration
C15.9 Esophageal cancer

MedClineMD is recognized by the FDA, EU, and TGA (Australia) for the medical purpose of treating nocturnal acid reflux related to GERD and laryngopharygeal reflux (LPR). Diagnostic codes outside of GERD would not be appropriate at this time. Available by Rx only, MedClineMD is indicated for GERD patients who are unresponsive to PPI medications; continue to suffer with breakthrough nocturnal symptoms; and/or for those who which drug interactions is a concern, especially polypharmacy concerns within the elderly population.

As DME, it is not appropriate to classify MedClineMD under the E0190 categorization. Prior commercial payers have billed MedClineMD utilizing HCPCS code E1399, which describes “durable medical equipment, miscellaneous” with diagnoses of gastroesophageal reflux disease or LPR. This code can be used to bill for inexpensive DME subject to the rules of 42 C.F.R.

CMS DME Criteria

E0190: Pillow/Cushion/Wedge

Can withstand repeated use;
Is primarily and customarily used to serve a medical purpose;
Generally not useful to a person in the absence of an illness or injury;
Is appropriate for use in the home; and
The equipment is necessary and reasonable for the treatment of the member’s illness or injury.

Clinically Proven Superiority

As a research-based company, validating MedClineMD as the most effective, natural treatment option for GERD is a top priority. To date, MedClineMD has been evaluated in eight clinical studies proving its clinical superiority. 

Medical University of South Carolina, Charleston, SC

There are volumes of research on elevated positioning and volumes on lateral positioning for nocturnal acid reflux relief. The MUSC clinical study was the first to combine these two positioning techniques. The compound inclined + left-side position was shown to be significantly more effective than either position alone offering a significantly more effective, natural treatment for nocturnal GERD.

Key Stat:
87% reduction of recumbent acid exposure compared to a bed wedge when on left side

Download Abstract

Reference: Person, EB, Rife CC, Castell DO, et al. A novel sleep-assist device prevents gastroesophageal reflux: A randomized controlled trial. Am J Gastroenterology 2013; 108:S1-S36.

Digestive Disease Institute, Cleveland Clinic, Cleveland, OH

Up to 40% of patients continue to experience symptoms despite daily use of anti-reflux medications leaving much of the GERD population without a complete treatment plan for their nighttime symptoms. Cleveland Clinic sought to determine if MedClineMD could bring relief to these patients. MedClineMD did.

Key Finding:
77% reduction in nocturnal GERD symptom scores for Refractory GERD patients

Download Abstract

Reference: Allampati S, Lopez R, Thota PN, Ray M, Birgisson S, Gabbard SL. Use of a Positional Therapy Device Significantly Improves Nocturnal Gastroesophageal Reflux Symptoms. Dis Esophagus. 2016 Sep 15. doi: 10.1111/dote.12495148, Issue 4, Supplement 1, Page S-617.

Head and Neck Institute, Cleveland Clinic, Cleveland, OH

While the most common symptoms of GERD are heartburn and regurgitation, extra-esophageal symptoms include chronic cough, asthma, hoarseness, laryngitis, chronic sinusitis, headaches, and dental erosions. These extra-esophageal symptoms are typically experienced by those patients suffering with laryngopharyngeal reflux (LPR) or silent reflux. Cleveland Clinic sought to determine if MedClineMD could bring relief to these patients too. MedClineMD did.

Key Finding:
75% improvement in LPR (silent reflux) symptoms scores after 4 weeks

Download Abstract

Reference: Gabbard SL, Tierney WS, Bryson PC. Use of a Positional Therapy Device Significantly Improves Nocturnal Laryngopharyngeal Reflux Symptoms. American Journal of Gastroenterology 2015; 110: S693-S739.

University of Southern California, Department of Thoracic Surgery

After an esophagectomy, patients need to sleep on an incline for the rest of their lives to avoid severe acid reflux due to the elimination of the lower esophageal sphincter (LES) during the surgical procedure. All of the patients in this Cleveland Clinic study were sleeping on an incline prior to the study, including sleeping on a bed wedge, in a recliner, or on an adjustable bed. MedClineMD brought superior relief to these patients than any other incline technique.

Key Finding:
95% of patients reported an overall improvement in sleep quality when using MedClineMD

Download Abstract

Reference: Boys JA, Om SA, Patel R, Oh DS, Hagen JA, DeMeester SR. Nocturnal Regurgitation after Esophagectomy Before and After Implementation of a Novel Sleep Assist Device. Journal of the American College of Surgeons, October 2015, Vol. 221, Issue 4, S14–S15.

Women’s Health Institute, Cleveland Clinic, Cleveland, OH

There are volumes of research on elevated positioning and volumes on lateral positioning for nocturnal acid reflux relief. The MUSC clinical study was the first to combine these two positioning techniques. The compound inclined + left-side position was shown to be significantly more effective than either position alone offering a significantly more effective, natural treatment for nocturnal GERD.

Key Finding:
87% reduction of recumbent acid exposure compared to a bed wedge when on left side

Download Abstract

Reference: Kichler A, Alzubaidi M, Emery J, Gabbard SL. Use of a Positional Therapy Device Significantly Improves Nocturnal Gastroesophageal Reflux Disease Symptoms in Pregnant Women. American Journal of Gastroenterology 2015; 110: S693-S739.

GI Departments at Kaiser Permanente, Northern and Southern California

MedClineMD was further validated through pilot program with Kaiser Permanente. Patients along the GERD continuum with uncontrolled nocturnal symptoms showed repeatable results in a managed care setting.

Key Finding:

Average N-GSSIQ Point Reduction: 34.6 points

Over 100,000 Patients Treated

MedClineMD is changing the lives of patients suffering from refractory GERD, LPR, and nocturnal acid reflux. 

So very pleased with Medcline! My husband has cancer had most of his stomach and esophagus removed. He could not sleep in bed due to acid reflux. I ordered Medcline and extremely pleased that he is able to sleep in bed in comfort! The best money I have ever spent! So very pleased with Medcline! My husband has cancer had most of his stomach and esophagus removed. He could not sleep in bed due to acid reflux. I ordered Medcline and extremely pleased that he is able to sleep in bed in comfort! The best money I have ever spent!

Laurie. S

My husband used to have terrible acid reflux to the point he would wake up and throw up bile. He was on medication that sometimes helped but not always. I bought one of these pillows for him using our FSA card. He said it takes a bit to get used to but he doesn’t wake up throwing up from acid reflux anymore so that’s worth it!’ My husband used to have terrible acid reflux to the point he would wake up and throw up bile. He was on medication that sometimes helped but not always. I bought one of these pillows for him using our FSA card. He said it takes a bit to get used to but he doesn’t wake up throwing up from acid reflux anymore so that’s worth it!’

Crystal S.

I’ve been using my ‘system’ for about two years now and love it. I no longer take medications for GERD! It is a pricey item but well worth it considering the cost of meds year over year!”‘ I’ve been using my ‘system’ for about two years now and love it. I no longer take medications for GERD! It is a pricey item but well worth it considering the cost of meds year over year!”‘

Howard. F

This has been life changing for me. I have horrible acid reflux and night time was the worst for me. At first, I thought I wasn’t going to like it took me about a week to get used to the pillow but now I love it. I’m off my night time meds so for me, it was worth every penny!’ This has been life changing for me. I have horrible acid reflux and night time was the worst for me. At first, I thought I wasn’t going to like it took me about a week to get used to the pillow but now I love it. I’m off my night time meds so for me, it was worth every penny!’

Felicia R.
I got my MedCline a few months ago. I suffer from Barrett’s esophagus which can cause severe reflux and that can lead to cancer so it is critical I not sleep laying flat. MedCline makes all the difference. Instead of being propped up on a bunch of pillows that I slide down off of once I am asleep I put my arms through the holes in the MedCline and it keeps me in place. I got my MedCline a few months ago. I suffer from Barrett’s esophagus which can cause severe reflux and that can lead to cancer so it is critical I not sleep laying flat. MedCline makes all the difference. Instead of being propped up on a bunch of pillows that I slide down off of once I am asleep I put my arms through the holes in the MedCline and it keeps me in place.
Cheri B.

I had esophageal cancer surgery 16 months ago. I absolutely have to maintain my proper sleep position in order to prevent reflux. I’ve tried several different wedges but none of them allowed me to stay in the proper position. The MedCline works great for me. Thanks for a wonderful product! I had esophageal cancer surgery 16 months ago. I absolutely have to maintain my proper sleep position in order to prevent reflux. I’ve tried several different wedges but none of them allowed me to stay in the proper position. The MedCline works great for me. Thanks for a wonderful product!

Debby S.

Dangers of GERD

The dangers posed specifically by nocturnal acid reflux are particularly significant as prolonged esophageal acid exposure has been linked to serious health complications4, such as:

  • Erosive esophagitis
  • Peptic stricture
  • Esophageal ulcerations
  • Barrett’s esophagus
  • Adenocarcinoma of the esophagus

Nocturnal acid reflux presents an 11-fold increase in the risk of developing esophageal adenocarcinoma, which is the fastest growing cancer in the United States.4

The PPI Problem. Growing in Scope and Urgency.

Drugs are not the solution.

In 2015, 29% of all Medicare Part D beneficiaries received a prescription for a proton pump inhibitor (PPI), a 12% increase from 2013. PPIs have created a minefield of drug-to-drug interactions, and in recent years, PPIs have been linked to very serious side effects with long-term use.

Contact Us

For questions regarding clinical studies, coding, and reimbursement:

info@amenityhealth.com

1-800-610-1607

Looking for cash-pay or HSA/FSA approved relief from nocturnal GERD?

www.MedCline.com

References
  1. Donnellan C, Sharma N, Preston C, Moayyedi P. Medical treatments for the maintenance therapy of reflux oesophagitis and endoscopic negative reflux disease. Cochrane Database Syst Rev 2005; 4: CD003245.
  2. Hussain ZH, Henderson EE, Maradey-Romerao C, George N, Fass R, Lacy BE. The Proton Pump Inhibitor Non-Responder: A Clinical Conundrum. Clinical and Translational Gastroenterology. 2015;6(8):e106-. doi:10.1038/ctg.2015.32.
  3. Allampati S, Lopez R, Thota PN, Ray M, Birgisson S, Gabbard SL. Use of a Positional Therapy Device Significantly Improves Nocturnal Gastroesophageal Reflux Symptoms. Dis Esophagus. 2016 Sep 15. doi: 10.1111/dote.12495148, Issue 4, Supplement 1, Page S-617.
  4. Lagergren, J, Bergstrom R, Lindgren A, et al. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med 1999; 340: 825-831.
  5. Fass R, Murthy U, Hayden CW, et al. Omeprazole 40 mg once a day is equally effective as lansoprazole 30 mg twice a day in symptom control of patients with gastro-oesophageal reflux disease (GERD) who are resistant to conventional-dose lansoprazole therapy-a prospective, randomized, multi-centre study. Aliment Pharmacol Ther 2000;14:1595-1603.
  6. Scarpignato C, Gatta L, Zullo A, et al. Effective and safe proton pump inhibitor therapy in acid-related diseases – A position paper addressing benefits and potential harms of acid suppression. BMC Medicine. 2016;14:179. doi:10.1186/s12916-016-0718-z.