Is the Wireless Motility Capsule (WMC) (i.e. SmartPill) safe and effective in the diagnosis and management of gastrointestinal motility disorders including gastroparesis and refractory constipation? Can it replace radiopaque markers?

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.: Is the Wireless Motility Capsule (WMC) (i.e. SmartPill) safe and effective in the diagnosis and management of gastrointestinal motility disorders including gastroparesis and refractory constipation? Can it replace radiopaque markers?
Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.): yes
If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:: Assessing motility and transit time using the traditional radiopaque markers.
What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.): Medicare population.
Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.): No.
Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.): Does this device improve diagnosis and management of patients with motility disorders?
Describe any health-related risks, side effects, or harms that you are concerned about.

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

AHRQ Priority Populations

Federal Health Care Program

Describe why this topic is important.: We have received a request from gastroenterologists to cover wireless motility capsue (WMC) rather than use the traditional radiopaque markers.
What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.): We have been requested to develop a Local Coverage Determination (LCD) that would cover WMC.
Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.): yes
If yes, please explain:: Is there any benefit for this device compared to traditional diagnostic tests?

How will an answer to your research question be used or help inform decisions for you or your group?: This answer will help us to decide whether to cover this new device for Medicare beneficiaries.
Describe the timeframe in which an answer to your question is needed.: 90 days.
Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate): This answer will help us to decide whether to cover this new device for Medicare beneficiaries.

Are you making a suggestion as an individual or on behalf of an organization?: Organization

Please tell us how you heard about the Effective Health Care Program: Presentation at the recent CMS LCD Writers Meeting

Effective Health Care Program