TEJSD Response to Comments - JA DME

June 2014

Summary

Comments fell broadly into three groups as described below. Since there was significant business overlap among the responding entities this is not unexpected.

Coverage - General

All commenters presented reasons to allow coverage primarily centered on review of published evidence available as of the date of their comment and/or their empirical experience of the effectiveness of the therapy.

Response:

CMS Program Integrity Manual (PIM) sets out specific standards to be met when making a determination that an item or service is reasonable and necessary (PIM 13.5.1) and the quality of the evidence required for that assessment (PIM 13.7.1). The quality of the evidence submitted is insufficient to conclude that reimbursement for TEJSD is reasonable and necessary.

Coverage - Specific Criteria

Several commenters proposed specific coverage criteria.

• Consider requiring a face-to-face visit with a specialist in the OA field prior to ordering and placement of the device. 
• This device should not be considered for first line of treatment.
• Patient selection by qualified professionals should be limited to those patients with Grade 2 or higher radiological evidence of OA, plus moderate to early-severe impairment on a suitable clinical evaluation scale (5 out of 10 on the Physicians' Global or equivalent), and failure of at least 3 months of conservative therapy including non-narcotic pharmaceuticals and physical therapy.

Response:

We agree that clear and specific criteria would be appropriate were the item to be covered. In the absence of an affirmative coverage determination, the recommendations are moot.

Coding

Some commenters noted that the coding guidelines were too broad and would allow devices to be included in the code that were too dissimilar to the predicate product for E0762. It was also suggested that some of the alternatives might be less effective than the predicate or ineffective. Suggestions were made for coding criteria.

Proposed E0762 requirements for medical devices granted an E0762 code.

1. Medical device must be indicated to treat a full range of symptoms of a joint disease such as osteoarthritis of the knee – not just pain,
   1. Improvement of pain
   2. Improvement of associated symptoms (e.g. morning stiffness and range of motion) of the joint disease being treated, such as osteoarthritis of the knee
   3. Overall improvement of the joint as assessed by Physicians Global Evaluation
2. Clinical efficacy must be demonstrated with two or more published short-term randomized, double-blind, prospective, placebo device controlled clinical studies producing statistically significant outcomes using standard, validated outcome measures used by the FDA or recognized professional organizations such as the American College of Rheumatology (ACR), including Physicians Global Evaluation.
3. Clinical safety must be demonstrated by two or more long-term clinical studies of at least a year or longer producing statistically significant outcomes demonstrating continued benefit and no long-term harm resulting from the treatment.
4. Scientific papers of these studies must be published in professionally-recognized peer reviewed medical journals.
5. Medical device must produce clinical and functional results similar to the predicate.
6. Electrical device applicant must provide evidence of efficacy and safety of every electrical signal used by the device in the treatment of osteoarthritis, including broad frequency ranging signal generators.
7. Devices must successfully undergo Pricing, Data Analysis and Coding (PDAC) review.

Response:

We agree that code verification review is appropriate for this code.

Testimonials/Letters of Support

Numerous letters and e-mails were received encouraging coverage.

Response:

CMS Program Integrity Manual (PIM) sets out specific standards to be met when making a determination that an item or service is reasonable and necessary (PIM 13.5.1) and the quality of the evidence required for that assessment (PIM 13.7.1).  Testimonials etc. are not deemed sufficient evidence to justify coverage.