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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 dates of service specified below, the Centers for Medicare & Medicaid Services 
(CMS) has determined that PILD will be covered by Medicare when provided in a clinical study under section 
1862(a)(1)(E)of the Social Security Act (the Act) through Coverage with Evidence Development (CED) for 
beneficiaries with LSS who are enrolled in an approved clinical study that meets the criteria in section I or II 
below: 
 
I. Effective for services performed on or after January 9, 2014, 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. 
 
    i. Does PILD provide a clinically meaningful improvement of function and/or quality of life in Medicare 
beneficiaries with LSS compared to other treatments? 
    ii. Does PILD provide clinically meaningful reduction in pain in Medicare beneficiaries with LSS compared 
to other treatments? 
   iii. Does PILD affect the overall clinical management of LSS and decision making, including use of other 
medical treatments or services, compared to other treatments? 
 
All CMS-approved clinical research studies must adhere to the following standards of scientific integrity and 
relevance to the Medicare population: 
 
    a. The principal purpose of the study is to test whether the item or service meaningfully improves health 
outcomes of affected beneficiaries who are represented by the enrolled subjects. 
 
 
   b. The rationale for the study is well supported by available scientific and medical evidence. 
   c. The study results are not anticipated to unjustifiably duplicate existing knowledge. 
   d. The study design is methodologically appropriate and the anticipated number of enrolled subjects is 
sufficient to answer the research question(s) being asked in the National Coverage Determination. 
   e. The study is sponsored by an organization or individual capable of completing it successfully. 
   f. The research study is in compliance with all applicable Federal regulations concerning the protection of 
human subjects found in the CFR at 45 CFR Part 46. If a study is regulated by the FDA, it is also in compliance 
with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies 
conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding 
the risks associated with the study items and/or services, and the use and eventual disposition of the collected 
data. 
    g. All aspects of the study are conducted according to appropriate standards of scientific integrity. 
   h. The study has a written protocol that clearly demonstrates adherence to the standards listed here as 
Medicare requirements. 
    i. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. 
Such studies may meet this requirement only if the disease or condition being studied is life threatening as 
defined in 21 CFR ?312.81(a) and the patient has no other viable treatment options. 
    j. The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the 
principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in 
the AHRQ Registry of Patient Registries (RoPR). 
    k. 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 12 months of the study?s primary completion date, which is the date the final 
subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The 
results must include number started/completed, summary results for primary and secondary outcome measures, 
statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in 
a peer-reviewed scientific journal (in print or on-line), in an on-line publicly accessible registry dedicated to the 
dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in 
abbreviated format (e.g., for studies with negative or incomplete results). 
    l. The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service 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 in 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. 
    m. The study protocol explicitly discusses how the results are or are not expected to be generalizable to 
affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations 
eligible for Medicare due to age, disability or Medicaid eligibility. 
 
    Consistent with section 1142 of the Act, tAHRQ supports clinical research studies that CMS determines 
meet the above-listed standards and address the above-listed research questions. 
 
You can find this information in Medicare's National Coverage Determination (NCD) for 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.