Wednesday, December 23, 2015

Noncovered services -- revision to the Part B LCD

LCD ID number: L29288 (Florida) LCD ID number: L29398 (Puerto Rico/U.S. Virgin Islands)

The Medical Policy & Procedures Department evaluated the following services and determined that they are not considered medically reasonable and necessary at this time based on current available published evidence (e.g., peer-reviewed medical literature, and published studies). Therefore, the following procedure codes have been added to the Noncovered Services LCD. After a draft LCD becomes effective/active, any stakeholder may request a revision to the LCD, by following the reconsideration process as outlined on our website.

• 0347T- Placement of interstitial device(s) in bone for radiostereometric analysis (RSA)
• 0348T – 0350T- Radiologic examination, radiostereometric analysis (RSA);
• 0351T - 0354T- Optical coherence tomography of breast
• 0355T- Gastrointestinal tract imaging, intraluminal (eg,capsule endoscopy), colon, with interpretation and report
• 0356T- Insertion of drug-eluting implant (including punctual dilation and implant removal when performed) into lacrimal canaliculus, each
• 0358T- Bioelectrical impedance analysis whole body composition assessment, supine position, with interpretation and report
• 0008M- Oncology (breast), MRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score. Prosigna™
• 0359T-Behavior identification assessment, by the physician or other qualified health care professional, face-to-face with patient and caregiver(s), includes administration of standardized and non-standardized tests, detailed behavioral history, patient observation and caregiver interview, interpretation of test results, discussion of findings and recommendations with the primary guardian(s)/caregiver(s), and preparation of report
• 0360T-0363T- Observational behavioral follow-up assessment
• 0364T-0374T- Adaptive behavior treatment by protocol, administered by technician, face-to-face with one patient; first 30 minutes of technician time

In determining if a service or procedure reaches the threshold for coverage, this contractor addresses the quality of the evidence per the program integrity manual.  When addressing the articles and related information in the public domain, the jurisdiction N (JN) Medicare administrative contractor (MAC) reached the determination that available evidence was of moderate to low quality, consisting of small case series, retrospective studies, and review articles reporting limited safety and efficacy data for sacroiliac joint fusion procedures for the treatment of pain-related sacroiliac conditions. Due to the unavailability of high quality evidence, the JN MAC reiterates that there is insufficient scientific evidence to support use of sacroiliac fusion in treating low back pain due to sacroiliac joint syndrome, and therefore is not considered reasonable and necessary under section 1862(a)(1)(a) of the Social Security Act.
Any denied claim would have Medicare’s appeal rights. The second level of appeal (Qualified Independent Contractor) requires review by a clinician to uphold any denial. Providers should submit for review all the relevant medical documentation and case specific information of merit and/or new information in the public domain.

An interested stakeholder can request a reconsideration of an LCD after the notice period has ended and the draft becomes active. In the case of the noncovered services LCD, the stakeholder may request the list of the articles and related information in the public domain that were considered by the Medical Policy department in making the noncoverage decision. If the stakeholder has new information based on the evaluation of the list of articles and related information, an LCD reconsideration can be initiated. It is the responsibility of the interested stakeholder to request the evidentiary list from the contractor and to submit the additional articles, data, and related information in support of their request for coverage. The request must meet the LCD reconsideration requirements outlined on the web site.

Also, any interested party could request CMS to consider developing a National Coverage Determination (NCD). Of note, if the evidence is not adequate for coverage under section 1862(a)(1)(A), an item or service may be considered for coverage under the CMS Coverage with Evidence Development (CED) policy in which “reasonable and necessary” is established under 1862(a)(1)(E) of the Act. Under the authority of section 1862(a)(1)(E), the NCD process may result in coverage if the item or service is covered only when provided within a setting in which there is a pre-specified process for gathering additional data, and in which that process provides additional protections and safety measures for beneficiaries, such as those present in certain clinical trials.

Effective date
The LCD revision is effective for services rendered on or after February 7, 2015.

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