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 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?
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).
l. 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.
m. 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:
1. 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.
2. 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.
3. 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 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.