100-02 Medicare Benefit Policy Manual: Chapter 14 - Medical Devices

Medicare Benefit Policy Manual
Chapter 14 - Medical Devices
Table of Contents
(Rev. 198, 11- 06-14)
Transmittals for Chapter 14
10 - Coverage of Medical Devices
20 - Food and Drug Administration (FDA)-Approved Investigational Device Exemption
(IDE) Studies
20.1 - Medicare Requirements for Coverage of Items and Services in
FDA-Approved Category A and B IDE Studies
20.2 - Payment for Items and Services in Category A and B IDE Studies
20.3 – FDA Withdrawal of IDE Approval or Change in Categorization
20.4 – Confidentiality of IDE Information
20.5 – Re-evaluation of FDA-approved IDE Device Categorization Decision
30 - Hospital Institutional Review Board (IRB) Approved Non-significant Risk Devices
30.1 – Payment for Hospital IRB Approved Non-significant Risk Devices
40 - Services Related to and Required as a Result of Services Which are Not Covered
Under Medicare

10 - Coverage of Medical Devices
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
The Food and Drug Administration (FDA) defines a medical device as an instrument,
apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or
related article, including a component part, or accessory which is:
• 	Recognized in the official National Formulary, or the United States Pharmacopoeia,
or any supplement to them,
• 	Intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
• 	Intended to affect the structure or any function of the body of man or other animals,
and which does not achieve any of its primary intended purposes through chemical
action within or on the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its primary intended purposes.
For dates of service on or after November 1, 1995, Medicare may cover certain FDA-
approved and Institutional Review Board (IRB)-approved investigational devices and
services incident to, provided the investigational device meets certain requirements,
including:
• 	The device or services associated with the use of a device were provided to the
beneficiary within the start and end dates contained in the master file;
• 	There are no regulations, national coverage policies, or manual instructions that
would otherwise prohibit Medicare coverage.
Devices that may be covered under Medicare include the following categories:
• 	Devices approved by the FDA through the Pre-Market Approval (PMA) process;
• 	Devices cleared by the FDA through the 510(k) process;
• 	FDA-approved Investigational Device Exemption (IDE) Category B devices; and
• 	Hospital IRB-approved non-significant risk devices.
• 	NOTE: Study sponsors are not required to seek Medicare coverage in order to
conduct their studies or trials.
20 - Food and Drug Administration (FDA)-Approved Investigational
Device Exemption (IDE) Studies
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)

NOTE: Throughout this section, the terms “study” and “trial” are used
interchangeably.
The FDA assigns a special identifier number that corresponds to each device granted an
IDE. For purposes of assisting the Centers for Medicare & Medicaid Services (CMS) in
determining Medicare coverage of items and services in IDE studies, the FDA will place
all approved IDE devices in one of two categories:
Category A (Experimental) device, which refers to a device for which “absolute risk” of
the device type has not been established (that is, initial questions of safety and
effectiveness have not been resolved) and the FDA is unsure whether the device type can
be safe and effective;
or
Category B (Non-experimental/investigational) device, which refers to a device for which
the incremental risk is the primary risk in question (that is, initial questions of safety and
effectiveness of that device type have been resolved), or it is known that the device type
can be safe and effective because, for example, other manufacturers have obtained FDA
premarket approval or clearance for that device type.
The FDA notifies CMS when it notifies the IDE study sponsor (i.e. manufacturer) that the
device is categorized as either Category A or Category B.
Routine care items and services refers to items and services that are otherwise generally
available to Medicare beneficiaries (that is, a benefit category exists, it is not statutorily
excluded, and there is not a national non-coverage decision) that are furnished during a
clinical study and that would be otherwise furnished even if the beneficiary were not
enrolled in a clinical study.
20.1 - Medicare Requirements for Coverage of Items and Services in FDA-
approved Category A and B IDE Studies
(Rev. 198, Issued: 11- 06-14, Effective: 01-01-15, Implementation: 01-05-15)
A. Category A IDE Studies
Medicare covers routine care items and services furnished in an FDA-approved
Category A IDE study if CMS (or its designated entity) determines that the Medicare
coverage IDE study criteria are met (as described below).
B. Category B IDE Studies
Medicare may make payment for a Category B IDE device and routine care items and
services furnished in an FDA-approved Category B IDE study if CMS (or its designated

entity) determines prior to the submission of the first related claim that the Medicare
coverage IDE study criteria are met (as described below).
C. Seeking CMS Approval of Category A and B IDE Studies for Purposes of Medicare
Coverage
Effective for Category A and B IDE studies approved by the FDA on or after January 1,
2015, interested parties (i.e., study sponsors) that wish to seek Medicare coverage in
Category A or B IDE studies must submit a request for review and approval via email to
clinicalstudynotification@cms.hhs.gov or via hard copy to the following address:
Centers for Medicare and Medicaid Services
Center for Clinical Standards and Quality
Director, Coverage and Analysis Group
ATTN: Clinical Study Certification
Mail Stop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244
Interested parties do not need to submit both electronic and hard copies of requests.
Each request must include the following information:
• 	A request letter that describes the scope and nature of the IDE study, discussing
how the interested party believes that the IDE study meets each of the Medicare
Coverage IDE Study Criteria (described below),
• 	FDA approval letter of the IDE,
• 	IDE study protocol,
• 	IRB approval letter (interested parties need only submit one IRB approval letter
with their request),
• 	NCT number, and
• 	Supporting materials, as appropriate.
For each Category A or B IDE study approved for purposes of Medicare coverage, CMS
will post on the CMS Coverage Website the following information:
• 	Study title,
• 	Sponsor name,
• 	NCT number,

• 	IDE number, and
• 	CMS approval date.
Providers participating in and seeking Medicare reimbursement for items and services in
Category A or B IDE studies, prior to submitting claims, are responsible for checking the
CMS Coverage Website to identify whether CMS (or its designated entity) has approved
the study for purposes of Medicare coverage.
NOTE: For billing requirements for items and services in FDA-approved Category A
and B IDE studies, see Pub. 100-04, Medicare Claims Processing Manual, chapter 32,
section 68.
Contractors must check the CMS Coverage Website list of approved Category A and B
IDE studies prior to processing related claims for Medicare payment.
D. Medicare Coverage IDE Study Criteria
For purposes of Medicare coverage of items and services in Category A and B IDE
studies, an IDE study must meet all of the following criteria:
1. 	The principal purpose of the study is to test whether the device improves health
outcomes of appropriately selected patients.
2. 	The rationale for the 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.
3. 	The study results are not anticipated to unjustifiably duplicate existing knowledge.
4. 	The study design is methodologically appropriate and the anticipated number of
enrolled subjects is adequate to confidently answer the research question(s) being
asked in the study.
5. 	The study is sponsored by an organization or individual capable of successfully
completing the study.
6. 	The study is in compliance with all applicable Federal regulations concerning the
protection of human subjects found at 21 CFR parts 50, 56, and 812, and 45 CFR
part 46.
7. 	Where appropriate, the study is not designed to exclusively test toxicity or disease
pathophysiology in healthy individuals. Studies of all medical technologies
measuring therapeutic outcomes as one of the objectives may be exempt from this

criterion only if the disease or condition being studied is life threatening and the
patient has no other viable treatment options.
8. 	The study is registered with the National Institutes of Health’s National Library of
Medicine’s ClinicalTrials.gov.
9. 	The study protocol describes the method and timing of release of results on all pre-
specified outcomes, including release of negative outcomes, and that the release
should be hastened if the study is terminated early.
10. The study protocol must describe how Medicare beneficiaries may be affected by the
device under investigation, and how the study results are or are not expected to be
generalizable to the Medicare beneficiary population. Generalizability to
populations eligible for Medicare due to age, disability, or other eligibility status
must be explicitly described.
NOTE: These requirements do not provide coverage for any devices or services that
would otherwise not be covered by Medicare outside the study (e.g., statutorily excluded
devices or items and services excluded from coverage through regulation or manual
instructions).
20.2 - Payment for Items and Services in Category A and B IDE Studies
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Payment for Category A and B IDE study routine care items and services, or Category B
IDE devices, may not exceed what Medicare would have paid for comparable approved
routine care items and services and devices.
20.3 - FDA Withdrawal of IDE Approval or Change in Categorization
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
If the FDA becomes aware that a categorized device no longer meets certain
requirements and a sponsor (e.g., a manufacturer) loses its Category B status, or violates
relevant IDE requirements necessitating FDA’s withdrawal of IDE approval, all payment
for the device and related routine care items and services should cease. The CMS master
file and CMS Coverage Website will be updated to reflect withdrawals of FDA IDE
approvals and categorization changes, as appropriate.
20.4 – Confidentiality of IDE Information
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Contractors may not release claims information or information received that is
proprietary in nature to the sponsor (e.g., a manufacturer). Since the IDE number as
well as other information will be necessary to process claims, the contractor must take
appropriate action to ensure that the confidentiality of the information is protected.

Because this information is proprietary in nature, the contractor may not release it under
the Freedom of Information Act.
20.5 – Re-evaluation of an FDA-approved IDE Categorization Decision
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Any sponsor (i.e., manufacturer) that does not agree with the FDA decision that
categorizes its device as Category A may submit a written request asking the FDA to
reevaluate its categorization decision. The sponsor (i.e., a manufacturer) may send a
written request to the FDA at any time asking for a reevaluation of its original
categorization decision, submitting any additional evidence and information which it
believes supports a re-categorization. The FDA notifies both CMS and the sponsor (i.e.,
manufacturer) of its reevaluation decision.
If the FDA reconfirms its original decision on the categorization of the device, the
sponsor (e.g., a manufacturer) may seek a review by the CMS Central Office. The device
sponsor (e.g., a manufacturer) must submit its request in writing, and must include all
materials submitted with its reevaluation request to the FDA. Review requests must be
addressed to:
Centers for Medicare & Medicaid Services
Attn: IDE Categorization Review
Mail Stop: S3-02-01
Coverage and Analysis Group,
Center for Clinical Standards and Quality,
7500 Security Blvd.
Baltimore, MD 21244-1850
The CMS staff will review this information to determine whether to change the
categorization of the device and will issue a written decision notifying both the device
sponsor (e.g., a manufacturer) and the FDA of its decision. In evaluating a
manufacturer’s request for re-categorization, CMS will review only that information
submitted to the FDA. Information not submitted to the FDA for its consideration will
not be reviewed by CMS.
To the extent that CMS relies on confidential commercial or trade secret information in
any judicial proceeding, CMS will maintain confidentiality of the information in
accordance with Federal law.
No reviews of a categorization decision other than those described above are available to
a sponsor (e.g., a manufacturer). Neither the FDA original categorization decision or
reevaluation, nor CMS’ review constitutes an initial determination for purposes of the
Medicare appeals processes under part 405, subpart G or subpart H or parts 417, 473,
or 498 of title 42 of the Code of Federal Regulations.

30 - Hospital Institutional Review Board (IRB) Approved Non-significant
Risk Devices
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Clinical trials for non-significant risk devices (devices which do not require an FDA-
approved IDE) are the responsibility of the hospital’s IRB. While these devices do not
require an FDA-approved IDE, many of the FDA-approved IDE requirements apply to
these non-significant risk devices (e.g., they may not be legally marketed). Medicare
contractors are responsible for making the coverage determinations on non-significant
devices that are the responsibility of the hospital’s IRB. Contractors should apply the
same coverage criteria, where appropriate, to these devices as are applied to FDA-
approved IDE Category A and B IDE devices.
30.1 – Payment for Hospital IRB Approved Non-significant Risk Devices
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Payment for an IRB approved device (provided to a non-hospital patient) and the related
services may not exceed what Medicare would have paid for a comparable approved
device and related services.
40 - Services Related to and Required as a Result of Services Which are
Not Covered Under Medicare
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Medicare payment is not made for medical and hospital services that are related to the
use of a device that is not covered under Medicare. These non-covered services include
all services furnished in preparation for the use of a non-covered device, services
furnished contemporaneously with, and necessary to the use of, a non-covered device,
and services furnished as necessary after-care that are incident to recovery from the use
of the device or from receiving related non-covered services.
Refer to Pub. 100-02, Medicare Benefit Policy Manual, Chapter 16, “General Exclusions
from Coverage,” §180 - “Services Related to and Required as a Result of Services Which
Are Not Covered Under Medicare.”

Transmittals Issued for this Chapter
Rev # 	Issue Date 	Subject 	Impl Date CR#
R198BP 	11/06/2014 	Medicare Coverage of Items and Services in
Category A and B Investigational Device
Exemption (IDE) Studies
01/05/2015 8921
R1BP 	10/01/2003 	Initial Publication of Manual 	NA 	NA
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