Appeal type: unknown
Decision: unknown

 
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  
I.  
a. 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. 
b. 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. 
II. 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: i. 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? 
ii. 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? 
iii. 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: 
iv. 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. 
v. 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. 
vi. 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: 
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 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). 
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 rule at Centers for 
Medicare and Medicaid Services, 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.