Wireless Gastrointestinal Motility Monitoring Systems

LCD Information Document Information Source LCD ID N/A LCD ID L33455 Original ICD-9 LCD ID Not Applicable LCD Title Wireless Gastrointestinal Motility Monitoring Systems Proposed LCD in Comment Period N/A Source Proposed LCD N/A Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 09/09/2021 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. 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Issue Issue Description Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, §1862(a)(7) states Medicare will not cover any services or procedures associated with routine physical checkups.42 Code of Federal Regulations, §410.32(a) diagnostic x-ray test, diagnostic laboratory tests and other diagnostic tests.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80, requirements for diagnostic x-ray, diagnostic laboratory, and other diagnostic tests. Coverage Indications, Limitations, and/or Medical Necessity A Wireless Gastrointestinal Motility Monitoring System is an ingestible capsule with the trade name SmartPill Opens in a new window®. The SmartPill® records data enabling the estimation of regional and total gastrointestinal motility. The device is Food and Drug Administration (FDA) approved to evaluate patients with suspected delayed gastric emptying and the evaluation of colonic transit time in patients with chronic idiopathic constipation. The capsule device measures pH, temperature, and pressure while traveling through the gastrointestinal (GI) tract, sending the data to a wireless receiver worn on or near the patient. The data can be used to determine GI motility, gastric emptying, small bowel transit, colonic transit, and whole gut transit times. The capsule can also provide pressure patterns within the GI tract. The study can be done in a physician office after the patient has discontinued use of all medications that affect the GI tract. Indications The Wireless Motility Capsule (WMC) has been studied in many centers. The capsule does not use radioactive materials and has minimal safety risks. Palmetto GBA will cover the device when: It is used by a gastroenterologist trained to use and interpret the results. It is used to evaluate and/or treat patients with suspected gastroparesis of any nature. It is used to evaluate colonic transit in patients with chronic idiopathic constipation lasting over 6 months. Basic clinical investigations, including endoscopy, have failed to elucidate a diagnosis. Limitations The WMC should not be administered to patients with a history of gastric bezoar, swallowing disorders, dysphagia, suspected strictures/fistulae in the GI tract, physiologic GI obstruction, GI surgery within the previous 3 months, Crohn’s disease, diverticulitis, or who have an implanted electromechanical medical device (such as pacemaker or infusion pump). The capsule is not FDA approved for use in children. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) N/A

A Wireless Gastrointestinal Motility Monitoring System is an ingestible capsule with the trade name SmartPill ® . The SmartPill ® records data enabling the estimation of regional and total gastrointestinal motility. The device is Food and Drug Administration (FDA) approved to evaluate patients with suspected delayed gastric emptying and the evaluation of colonic transit time in patients with chronic idiopathic constipation. The capsule device measures pH, temperature, and pressure while traveling through the gastrointestinal (GI) tract, sending the data to a wireless receiver worn on or near the patient. The data can be used to determine GI motility, gastric emptying, small bowel transit, colonic transit, and whole gut transit times. The capsule can also provide pressure patterns within the GI tract. The study can be done in a physician office after the patient has discontinued use of all medications that affect the GI tract. Indications The Wireless Motility Capsule (WMC) has been studied in many centers. The capsule does not use radioactive materials and has minimal safety risks. Palmetto GBA will cover the device when: It is used by a gastroenterologist trained to use and interpret the results. It is used to evaluate and/or treat patients with suspected gastroparesis of any nature. It is used to evaluate colonic transit in patients with chronic idiopathic constipation lasting over 6 months. Basic clinical investigations, including endoscopy, have failed to elucidate a diagnosis. Limitations The WMC should not be administered to patients with a history of gastric bezoar, swallowing disorders, dysphagia, suspected strictures/fistulae in the GI tract, physiologic GI obstruction, GI surgery within the previous 3 months, Crohn’s disease, diverticulitis, or who have an implanted electromechanical medical device (such as pacemaker or infusion pump). The capsule is not FDA approved for use in children.