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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 state that effective for dates of service specified below, the Centers for Medicare & Medicaid 
Services (CMS) has determined that Percutaneous Image-Guided Lumbar Decompression (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: 
 
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. 
 
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. 
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports 
clinical research studies that CMS determines meet the above-listed standards and address the above-listed 
research questions. 
 
Effective for services performed on or after December 7, 2016, CMS will cover through a prospective, 
longitudinal study PILD procedures using an FDA-approved/cleared device that completed a CMS-approved 
randomized control trial (RCT) that met the criteria listed in section I above. 
The CMS-approved prospective, longitudinal study must answer at least one of the following questions: 
 
Does PILD provide a clinically meaningful improvement of function (e.g., reduced acute and post-acute 
hospitalizations, nursing home care or inpatient rehabilitation services) and/or quality of life in Medicare 
beneficiaries with LSS compared to other treatments? 
Does PILD provide a clinically meaningful reduction in pain (e.g., as measured by class, dose, duration of 
prescription pain medication use) in Medicare beneficiaries with LSS compared toother treatments? 
Does PILD affect the overall clinical management of LSS and decision making, including use of other medical 
treatments or services (e.g., repeat PILD procedures, other interventions and surgical treatments), compared to 
other treatments? 
The prospective, longitudinal study must also meet the following criteria: 
 The 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 the benefit. 
The eligibility requirements, both inclusion and exclusion criteria that were specified in the CMS-approved 
RCT protocol, must be maintained in the new prospective, longitudinal study. 
All study sites and study results must be listed in the ClinicalTrials.gov database. 
All CMS-approved clinical research studies must adhere to the following standards of scientific integrity and 
relevance to the Medicare population: 
 
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. 
 
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. 
The rationale for the study is well supported by available scientific and medical evidence. 
The study results are not anticipated to unjustifiably duplicate existing knowledge. 
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. 
The study is sponsored by an organization or individual capable of completing it successfully. 
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. 
All aspects of the study are conducted according to appropriate standards of scientific integrity. 
The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare 
requirements. 
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. 
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). 
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 studys 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). 
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. 
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. 
 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.