LCD Reference Article Response To Comments Article

Response to Comments: Colon Capsule Endoscopy (CCE)

A58618

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A58618
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Article Title
Response to Comments: Colon Capsule Endoscopy (CCE)
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Response to Comments
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04/12/2021
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The comment period for the Colon Capsule Endoscopy (CCE) DL38755 Local Coverage Determination (LCD) began on 9/3/2020 and ended on 11/7/2020. The notice period for L38755 begins on 2/25/21 and will become effective on 4/11/21. The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

We are pleased to submit comments to on the proposed Local Coverage Determination Colon Capsule Endoscopy (DL38755).

We appreciate the effort that went into the development of the Proposed LCD Colon Capsule Endoscopy. We are pleased that the proposed LCD CCE is largely in alignment with the FDA approved indications for PillCam COLON 2. We appreciate, in particular, the recognition that PillCam COLON 2 qualifies for Medicare coverage as a diagnostic test, that it is safe and effective, as well as reasonable and necessary for a defined patient population.

As the manufacturer of CCE, we do, however, have some concerns with the Covered Indications in the Proposed LCD and we offer the following comments for Palmetto’s consideration.

Covered Indications

Primary Procedures

We appreciate the inclusion of medical necessity criteria for CCE as a primary procedure for patients with major risks for Optical Colonoscopy (OC) or moderate sedation as indicated from an evaluation of the patient by the physician.

In addition, we commend the recognition of physician autonomy concerning procedural risk decision making. We strongly believe these decisions are best left to the patient’s physician to determine based on the patient’s clinical presentation or history. Any additional requirements to this criterion could create unnecessary barriers to CCE as a diagnostic option; thus, potentially negatively impacting the continuum of care or early diagnosis and patient prognosis.

The proposed LCD’s criteria for CCE as a primary procedure for patients with major risks for OC or moderate sedation includes the requirement of either Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) or Multitarget Stool DNA (sDNA) Test positive. The FDA cleared indication for PillCam Colon does not define “evidence of lower GI bleeding.” We agree that FOBT and sDNA tests would help identify those patients with occult GI bleeding.

However, hemodynamically stable patients with overt GI bleeding, such as those with scant intermittent melena or hematochezia, may be candidates for PillCam and may not necessarily undergo a stool test given presumed positivity of the test. Therefore, requiring a positive stool test in these patients seems unnecessary. Therefore, we propose the addition of a third bullet point, “OR other evidence of lower GI bleeding.“

We also request consideration that additional ICD-10 codes be added to the Local Coverage Article: Billing and Coding: Colon Capsule Endoscopy (DA58321) including:

             K92.1 melena

             K92.2 gastrointestinal hemorrhage, unspecified

Secondary Procedures

Under the proposed LCD, CCE is covered as a secondary procedure for the surveillance of colon polyp(s) in previously diagnosed patients where OC was incomplete with adequate preparation and a complete evaluation of the colon was not technically possible or was contraindicated.

The proposed language would allow CCE as a secondary procedure after incomplete OC only in the setting of previously diagnosed polyps. However, the FDA cleared indication for CCE allows the device to be used for the detection of colon polyps after incomplete OC with adequate prep, regardless of history of colon polyps.

We are concerned that the proposed use of CCE after an incomplete colonoscopy is limited to patients with a history of polyps. When a colonoscopy is incomplete, the proximal colon may not be completely evaluated, potentially missing relevant polyps or other colonic findings. Under the proposed policy, a patient is required to have a prior polyp identified before CCE is medically necessary. This restriction limits the use of CCE in an important subset of patients that may have a polyp or other colonic findings in the proximal colon, however it was never detected because the proximal colon was not accessible by the colonoscope.

The importance of visualizing the proximal colon to the cecum is well supported in literature as listed below. Intubation of the cecum is of critical importance because interval cancers are often located in the proximal colon and the development of interval cancers is more frequent after an incomplete exam. Therefore, it important that providers have CCE as a diagnostic option to visualize the portion of the colon that could not be examined during the index colonoscopy.

  • Rex DK, Petrini JL, Baron TH, et Quality indicators for colonoscopy. Am J Gastroenterol. 2006 Apr;101(4):873-85.
  • Brenner H, Chang-Claude J, Seiler CM, et Interval cancers after negative colonoscopy: population-based case-control study. Gut. 2012 Nov;61(11):1576-82.
  • Lieberman DA, Holub JL, Morris CD, et Low rate of large polyps (>9 mm) within 10 years after an adequate baseline colonoscopy with no polyps. Gastroenterology. 2014 Aug;147(2):343-50.
  • Leaper M, Johnston MJ, Barclay M, et Reasons for failure to diagnose colorectal carcinoma at colonoscopy. Endoscopy. 2004 Jun;36(6):499-503.
  • Baxter NN, Sutradhar R, Forbes SS, et Analysis of administrative data finds endoscopist quality measures associated with postcolonoscopy colorectal cancer. Gastroenterology. 2011 Jan;140(1):65-72.
  • Brenner H, Chang-Claude J, Jansen L, et Role of colonoscopy and polyp characteristics in colorectal cancer after colonoscopic polyp detection: a population-based case-control study. Ann Intern Med. 2012 Aug 21;157(4):225-32.

In addition, a number of studies have been published on the use of PillCam Colon after incomplete OC regardless of previous history of polyps or GI bleeding. Please see references below for studies that were not referenced in the Draft LCD bibliography.

  • Nogales, et Therapeutic impact of colon capsule endoscopy with PillCam Colon 2 after incomplete standard colonoscopy: a Spanish multicenter study. Rev Esp Enferm Dig. 2017;109(5):322-327.
  • Baltes, et PillCam Colon 2 after incomplete colonoscopy – A prospective multicenter study. World J Gastroenterol. 2018;24(31):3556-3566.
  • Triantafyllou, et al. Colon capsule endoscopy is feasible to perform after incomplete colonoscopy and guides further workup in clinical Gastrointest Endosc. 2014;79:307-316.
  • Franco, et Approach to incomplete colonoscopy: new techniques and technologies. Gastroenterology and Hepatology. 2017;13(8): 476-483.

We recognize that CCE should not be used as a primary screening test for colorectal cancer and nor are we requesting coverage for CCE as a screening test. Moreover, we recognize the challenges and difficulties that contractors are facing when developing LCDs for diagnostic tests that do not conflict with Medicare’s coverage for colorectal cancer screening tests. We recognize that the proposed LCD has attempted to establish a fair and accurate CCE coverage policy. We are, however, concerned the proposed criteria will limit CCE access to patients after incomplete colonoscopy; therefore, we request modification to the currently proposed language to better reflect the FDA cleared indication for PillCam Colon and supporting literature.

We propose the following alternative phrasing for consideration: “Secondary procedure for the detection or surveillance of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.”

Conclusion

We appreciate the opportunity to submit these comments. If you have any questions or would like further information, please do not hesitate to contact me.

References were provided for review.

Thank you for your comments. We have revised the indications for primary and secondary procedures to include "other evidence of lower GI bleeding in hemodynamically stable patients" as a third bullet. We have added diagnosis codes K92.1 (melena) and K92.2 (gastrointestinal hemorrhage, unspecified) as codes that support medical necessity. We have revised the secondary procedure wording to state "for the detection or surveillance of colon polyp(s) if the diagnostic OC was incomplete OR…."

2

We appreciate the opportunity to make the following comments. We offer the following language for consideration to the History/Background and/or General Information section:

  • Request to strike language noted below as it is device specific.
    • “As the capsule travels through the digestive tract, the camera takes pictures that are transmitted to a recorder worn by the patient. The images are then transmitted to a computer with special software where the images are strung together to create a video. The provider reviews the video to look for any abnormalities within the gastrointestinal tract."
  • We request that you consider instead:
    • “As the capsule travels through the digestive tract, the camera system takes pictures. The images are then transmitted to a computer with special software where the images are strung together to create a video. The provider reviews the video to look for any abnormalities within the gastrointestinal tract."

We request that the reference in the Notice section with live link to the PillCam Colon 2 be removed as other CCE devices in development will be cleared for marketing in the future. Instead we offer the following language be added to the Coverage Indications, Limitations and/or Medical Necessity.

  • CCE devices are covered when the device has received Food and Drug Administration (FDA) Premarket Approval (PMA) or FDA clearance for that device's FDA-approved or cleared indication, or is used in a CMS approved clinical trial and meet all of the conditions specified.

Further, in the Summary of Evidence Section, we request that the following sentence be struck from the text as it implies that the policy is device/brand specific. This is inconsistent with other draft MAC policies for CCE and removal of the language will minimize confusion when other devices are cleared for marketing.

  • PillCam™ COLON 2 is a capsule endoscopy device.

Finally, we suggest the following change to the Limitations number 2. Patients with a cardiac pacemaker or another implanted electro-medical device. The current issue with patient who have an electro-medical device is because the currently approved colon capsule endoscopy device emits a radiofrequency signal. Devices in development do not and therefore, patients with an implanted electro-medical device would be able to have a procedure if it were performed with such a device when it is cleared for marketing by the U.S. Food and Drug Administration. We request that the language be updated to read:

  1. Patients with a cardiac pacemaker of another implanted electro-medical device if the CCE device is contraindicated due to emission of a radiofrequency signal or other interfering signal.

Thank you for your consideration of these comments and the recognition of CCE as an important diagnostic device for appropriate patients.

Thank you for your comments. We have revised the History/background and/or General Information section as suggested and have reworded limitation #2.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L38755 - Colon Capsule Endoscopy (CCE)
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Updated On Effective Dates Status
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Keywords

  • Colon Capsule Endoscopy
  • CCE