Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

novel procedure known as MILD (minimally invasive lumbar decompression) under investigation for the treatment of lumbar spinal stenosis. Heavily marketed as superior to open procedure though the FDA indication is limited to a subset of patients (Vertos Medical makes the kithttp:// www.vertosmed.com/physician/mild_procedure_anim.php) A) Is MILD superior to an indicated lumbar laminectomy for a patient suffering from spinal stenosis- what is the quality of the evidence B) MILD vs. sham- what it the quality of the evidence C) MILD vs interventional pain management procedures for pain (such as epidural injections) neurogenic claudication- what is the quality of the evidence D) When is Rx for spinal stenosis indicated with any surgical procedure – open, percutaneous, or so called "minimally invasive"

Outcomes- recurrence of pain, functional disability, operative complications short and long term.

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:

Open surgical vs. percutaneous vs. this so called minimally invasive approach vs. non-surgical medical management (including analgesics/steroid injections)

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.)

Lumbar spinal stenosis can be a degenerative process and would be most common in the Medicare age group

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Sub group analysis may be helpful but more important to assess the patient selection for the reported results which may bias results in the public domain

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Decreased or elimination of pain and improved functional status (walking etc). Fewer complications than open procedure if compared adequately.

Describe any health-related risks, side effects, or harms that you are concerned about.

Procedure complications. Procedure done by non-surgeons. Post complication- infection, pain etc. Longer term. Need for open procedure or more non-surgical medical management.

Appropriateness for EHC Program

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)

• Arthritis and nontraumatic joint disorders
• Functional limitations and disability

AHRQ Priority Populations

• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Spinal stenosis is a common condition (lumbar in this case)- when to Rx and how to intervene requires a comprehensive patient assessment. Procedures can be driven by specialty interest. This appears to be an issue of interventional pain physicians learning a new technique to address pain though the intervention can impact structure and function. Neurosurgeons and Orthopedic spine physicians have yet to assess the role of such approaches and the published literature on this procedure to date has some inherent bias that needs vetting.

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.)

As a Medicare Administrative Contractor, we non cover this procedure and have been concerned with the adequacy of the data. We have had challenges to our non coverage policy. Interventions for symptoms related degenerative spine conditions are high utilization.

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:

Noncoverage – stakeholders disagree. Many neurosurgeons agree that the data has not reached the threshold for coverage.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

Will impact help improve local coverage determinations (Medicare local policy)

Describe the timeframe in which an answer to your question is needed.

asap

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Unfortunately there can be over utilization of pain therapies and this procedure should be clarified as a definitive treatment under investigation or as pain management intervention under investigation for the vulnerable elderly population. The complication rates need to be better understood in regard to this procedure as well as the positive outcomes.

Nominator Information

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)

Will impact help improve local coverage determinations (Medicare local policy)

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