Friday, June 19, 2015

Noncovered services -- revision to the Part B LCD

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 local coverage determination (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.

• 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
• 0347T- Placement of interstitial device(s) in bone for radiostereometric analysis (RSA)
• 0348T – 0350T- Radiologic examination, radiostereometric analysis (rsa)
• 0351T - 0352T- Optical coherence tomography of breast or axillary lymph node, excised tissue, each specimen
• 0353T – 0354T - Optical coherence tomography of breast, surgical cavity
• 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
• 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 - Observational behavioral follow-up assessment, includes physician or other qualified health care professional direction with interpretation and report, administered by one technician; first 30 minutes of technician time, face-to-face with the patient
• 0361T - Observational behavioral follow-up assessment, includes physician or other qualified health care professional direction with interpretation and report, administered by one technician; each additional 30 minutes of technician time, face-to-face with the patient (List separately in addition to code for primary service)
• 0362T - Exposure behavioral follow-up assessment, includes physician or other qualified health care professional direction with interpretation and report, administered by physician or other qualified health care professional with the assistance of one or more technicians; first 30 minutes of technician(s) time, face-to-face with the patient
• 0363T - Exposure behavioral follow-up assessment, includes physician or other qualified health care professional direction with interpretation and report, administered by physician or other qualified health care professional with the assistance of one or more technicians; each additional 30 minutes of technician(s) time, face-to-face with the patient (List separately in addition to code for primary procedure)
• 0364T - 0365T- Adaptive behavior treatment by protocol, administered by technician, face-to-face with one patient
• 0366T – 0367T - Group adaptive behavior treatment by protocol, administered by technician, face-to-face with two or more patients
• 0368T – 0369T - Adaptive behavior treatment with protocol modification administered by physician or other qualified health care professional with one patient
• 0370T - Family adaptive behavior treatment guidance, administered by physician or other qualified health care professional (without the patient present)
• 0371T - Multiple-family group adaptive behavior treatment guidance, administered by physician or other qualified health care professional (without the patient present)
• 0372T - Adaptive behavior treatment social skills group, administered by physician or other qualified health care professional face-to-face with multiple patients
• 0373T – 0374T - Exposure adaptive behavior treatment with protocol modification requiring two or more technicians for severe maladaptive behavior(s)

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 these procedures. Due to the unavailability of high quality evidence, the JN MAC reiterates that there is insufficient scientific evidence to support these procedures, and therefore they are 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 website.

Also, any interested party could request the Centers for Medicare & Medicaid Services (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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