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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
The rules say that effective for services performed on or after January 9, 2014, Percutaneous Image-Guided 
Lumbar Decompression (PILD) will be covered by Medicare through CED for beneficiaries with LSS who are 
enrolled in an approved clinical study that meets the following criteria. CMS has a particular interest in 
improved beneficiary function and quality of life, specific characteristics that identify patients who may benefit 
from the procedure, and the duration of benefit. A clinical study seeking Medicare payment for PILD for LSS 
must address one or more aspects of the following questions in a prospective, randomized, controlled design 
using current validated and reliable measurement instruments and clinically appropriate comparator treatments, 
including appropriate medical or surgical interventions or a sham controlled arm, for patients randomized to the 
non-PILD group. 
The study protocol must specify a statistical analysis and a minimum length of patient follow up time that 
evaluates the effect of beneficiary characteristics on patient health outcomes as well as the duration of benefit. 
 
Does PILD provide a clinically meaningful improvement of function and/or quality of life in Medicare 
beneficiaries with LSS compared to other treatments? 
Does PILD provide clinically meaningful reduction in pain in Medicare beneficiaries with LSS compared to 
other treatments? 
Does PILD affect the overall clinical management of LSS and decision making, including use of other medical 
treatments or services, compared to other treatments? 
These studies must be designed so that the contribution of treatments in addition to the procedure under study 
are either controlled for or analyzed in such a way as to determine their impact. 
 The principal purpose of the research study is to test whether a particular intervention potentially improves the 
participants health outcomes. 
The research study is well supported by available scientific and medical information or it is intended to clarify 
or establish the health outcomes of interventions already in common clinical use. 
The research study does not unjustifiably duplicate existing studies. 
The research study design is appropriate to answer the research question being asked in the study. 
The research study is sponsored by an organization or individual capable of executing the proposed study 
successfully. 
The research study is in compliance with all applicable Federal regulations concerning the protection of human 
subjects found at 45 Code of Federal Regulations (CFR) Part 46. If a study is regulated by the Food and Drug 
Administration (FDA), it must be in compliance with 21 CFR parts 50 and 56. 
All aspects of the research study are conducted according to appropriate standards of scientific integrity (see 
http://www.icmje.org). 
The research study has a written protocol that clearly addresses, or incorporates by reference, the standards 
listed here as Medicare requirements for CED coverage. 
The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy 
individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet 
this standard only if the disease or condition being studied is life threatening as defined in 21 CFR312.81(a) 
and the patient has no other viable treatment options. 
The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator 
prior to the enrollment of the first study subject. 
The research study protocol specifies the method and timing of public release of all prespecified outcomes to 
be measured including release of outcomes if outcomes are negative or study is terminated early. The results 
must be made public within 24 months of the end of data collection. If a report is planned to be published in a 
peer reviewed journal, then that initial release may be an abstract that meets the requirements of the 
International Committee of Medical Journal Editors (http://www.icmje.org ). 
The research study protocol must explicitly discuss subpopulations affected by the treatment under 
investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and 
exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said 
populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the 
recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are 
necessary. 
The research study protocol explicitly discusses how the results are or are not expected to be generalizable to 
the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate 
discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or 
Medicaid eligibility. 
 
You can find this information in the National Coverage Determination (NCD) Percutaneous Image-Guided 
Lumbar Decompression for Lumbar Spinal Stenosis 150.13. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.