Local Coverage Determination (LCD)

Wireless Gastrointestinal Motility Monitoring Systems

L33455

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

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

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Current Dental Terminology © 2023 American Dental Association. All rights reserved.

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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 Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

The documentation in the patient’s medical record must support the need for the WMC test as it relates to the patient’s medical condition. The record must be legible and meet the coverage criteria given in the indications and limitations section of this policy. The medical record must also include evidence that the procedure was performed. The WMC test will be denied as not reasonable and necessary if the record is illegible or does not contain the required documentation to support a medical necessity for the test.

Sources of Information
N/A
Bibliography
  1. Camilleri M, Thorne NK, Ringel Y, et al. Wireless pH-motility capsule for colonic transit: Prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterol Motil. 2010;22(8):874-882.
  2. Rauch S, Krueger K, Turan A, You J, Roewer N, Sessler DI. Use of wireless motility capsule to determine gastric emptying and small intestinal transit times in critically ill trauma patients. Journal of Critical Care. 2012; 27(5):534.e7 - 534.e12.
  3. Saad RJ, Hasler WL. A technical review and clinical assessment of the wireless motility capsule. Gastroenterology and Hepatology. 2011;7(12):795-804.
  4. Tran K, Brun R. Kuo B. Evaluation of regional and whole gut motility using the wireless motility capsule: Relevance in clinical practice. Therapeutic Advances in Gastroenterology. 2012;5(4):249-260.
  5. United Healthcare Medical Policy. Gastrointestinal Motility Disorders, Diagnosis and Treatment. Effective 5/1/2019. Accessed 8/3/21.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
09/09/2021 R10

Under Coverage Indications, Limitations and/or Medical Necessity moved the hyperlink for FDA indication to this section from the Sources of Information section. Under Bibliography changes were made to citations to reflect AMA citation guidelines.

  • Provider Education/Guidance
10/24/2019 R9

This LCD is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Wireless Gastrointestinal Motility Monitoring Systems A56724 article.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
07/25/2019 R8

All coding located in the Coding Information section has been moved into the related Billing and Coding: Wireless Gastrointestinal Motility Monitoring Systems A56724 article and removed from the LCD. 

Under Sources of Information added U.S. Food and Drug Administration (FDA) source for SmartPill®. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the LCD. 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
02/26/2018 R7 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
10/01/2017 R6

Under ICD-10 Codes that Support Medical Necessity deleted ICD-10 code K56.69. This revision is due to the 2017 Annual ICD-10 Updates.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
05/11/2017 R5 Under CMS National Coverage Policy for Title XVIII of the Social Security Act, §1862(a)(1)(A) revised the verbiage to read “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” and for Title XVIII of the Social Security Act, §1862(a)(7) revised the verbiage to read “states Medicare will not cover any services or procedures associated with routine physical checkups”.
  • Provider Education/Guidance
10/01/2016 R4 Under ICD-10 Codes That Support Medical Necessity added ICD-10 codes K59.03, K59.04, K58.1, K58.2 and K58.8. This revision is due to the Annual ICD-10 Code Update and becomes effective 10/1/16.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
06/03/2016 R3 Under CMS National Coverage Policy the acronym SSA was removed throughout the section. The word “check-ups” was replaced with “examinations” in the second citation. The spelling of “diagnostic” was corrected in the fourth citation. In references five through seven, the “s” was removed from “Manuals” and “Publication” was abbreviated to “Pub.”. In the sixth reference the abbreviation for chapter was replaced with the word “Chapter”. The “s” was removed from “requirements” in the seventh citation. The citations were corrected to conform to the American Medical Association citation style. Under Coverage Indications, Limitations and/or Medical Necessity “SmartPill” was rewritten “SmartPill®”, to denote the trademark. The words “is” and “approved” were added and the acronyms FDA and GI were defined. Under Indications corrected “Mobility” to Motility” and created two sentences to form the paragraph, adding “s” to patient in the third bullet. Under Limitations an “a” was added before the word “pacemaker”. Under Associated Information – Documentation Requirements the paragraph was rephrased to more clearly define the documentation requirements. Under Sources of Information and Basis for Decisionthe month was removed the month from the first four references and the formatting corrected.
  • Provider Education/Guidance
  • Typographical Error
10/01/2015 R2 Under CMS National Coverage Policy in sixth citation, removed “-10.1.7, ICD-9-CM Coding for Diagnostic Tests” and added “General Rules for Diagnosis Codes” due to CR 8692. Under Sources of Information and Basis for Decision, in first reference, removed authors’ names Hasler WL, Kuo B, and Esfandyari T, and removed doi to remain consistent with AMA format. Corrected page numbers in this reference and in fourth reference.

  • Provider Education/Guidance
  • Other (Maintenance
    Annual Review)
10/01/2015 R1 Under CMS National Coverage Policy added citations, Title XVIII of the Social Security Act, Section §1862 (a) (7), excludes routine physical check-ups, and CMS Internet-Only Manuals, Publication 100-04, Medicare Claims Processing Manual, Chapter 23, §10.1 - 10.1.7 ICD-9-CM Coding for Diagnostic Tests. Under Sources of Information and Basis for Decision added the Volume, issue and page numbers to reference #2.
  • Provider Education/Guidance
  • Public Education/Guidance
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
09/03/2021 09/09/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • WGMMS

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