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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 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? 
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. 
a. The principal purpose of the research study is to test whether a particular intervention 
potentially improves the participants health outcomes. b. 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. 
c. The research study does not unjustifiably duplicate existing studies. 
d. The research study design is appropriate to answer the research question being asked in the 
study. 
e. The research study is sponsored by an organization or individual capable of executing the 
proposed study successfully. 
f. 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. 
g. All aspects of the research study are conducted according to appropriate standards of scientific 
integrity (see http://www.icmje.org). 
h. The research study has a written protocol that clearly addresses, or incorporates by reference, 
the standards listed here as Medicare requirements for CED coverage. 
i. 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. 
j. 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. 
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 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 
You can find this rule at the Medicare National Coverage Determination (NCD) 150.13: Percutaneous Image-
Guided Lumbar Decompression for Lumbar Spinal Stenosis. 
 
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.