What Does Medicare Cover In Device Trials? Medicare Part

what does medicare cover in device trials? medicare part b now considers coverage for some investigational devices if the food and drug adm

What does Medicare cover in Device trials?
Medicare Part B now considers coverage for some investigational
devices if the Food and Drug Administration (FDA) considers the
device(s) safe and/or effective.
This expanded coverage became effective for claims received on or
after Oct. 1, 1996, for dates of service on or after Nov. 1, 1995.
Under this policy, CMS and the FDA have reclassified devices
undergoing clinical trials to allow Medicare coverage for some of the
devices.
The new policy revises Medicare’s previous policy stating that all
medical devices studied in clinical trials are experimental, and
therefore, not reasonable and necessary and not covered. The new
policy categorizes the devices as follows:
*
Category A consists of novel, first-of-a-kind technologies.
Because the FDA cannot verify the safety and effectiveness of
these experimental devices, Medicare will not consider them for
coverage and will exclude payment.
*
Category B consists of devices that are newer generations of
proven technologies. Because initial questions of safety and
effectiveness have been resolved, Medicare will consider these
devices for payment consideration.
Medicare may cover devices that are:
Approved by FDA through the Pre-Market approval (PMA) process
Cleared by FDA through the 510 (k) process.
FDA-approved Investigational Device Exemption (IDE) Category B
devices.
Hospital Institutional Review Board (IRB) approved IDE devices
Other medical devices not requiring FDA approval
Keep in mind that Medicare will not cover all devices that fall into
Category B unless they meet Medicare’s other coverage requirements as
determined by the Local Medicare contractor/ carrier and meet the
criteria below:
1.
The device must be used within the context of the FDA approved
clinical trial with each device available at a certain number of
sites, for a specified number of patients
2.
The device must be used according to the clinical trial’s approved
patient protocols
3.
Established national policy as contained in existing manual
instructions (e.g., Coverage Issues Manual instructions, etc.) NCD
http://www.cms.hhs.gov/ClinicalTrialPolicies/
4.
In the absence of national policy, local policy for similar
FDA-approved devices Policy/position papers or recommendations
made by pertinent national and or local specialty societies
5.
The device must be medically necessary for the particular patient,
and you must determine whether the amount, duration, and frequency
of use or application of the service are medically appropriate
6.
Furnished in a setting appropriate to the patient’s medical needs
and condition
The policy does not provide coverage for any devices not otherwise
covered by Medicare Part B, (e.g., statutorily excluded devices, or
items or services excluded from coverage through regulation or current
manual instructions).
How do we get Medicare’s approval to bill for Investigational Device
Trials?
Effective January 1, 2015, the Centers for Medicare and Medicaid
Services added criteria for coverage of investigational device
exemption (IDE) studies that changed from local Medicare
administrative contractor (MAC) review and approval to a centralized
review and approval.
https://www.cms.gov/Medicare/Coverage/IDE/index.html
It is the responsibility of the investigator of the clinical trial to
furnish all necessary information concerning the device, the clinical
trial and participating Medicare beneficiaries that the contractor
deems necessary for a coverage determination and claims processing.
Each research site submits a written coverage request to the Local
Medicare director before submitting claims for the IDE devices and
services.
Reminder: Notification of the intent to participate in and submit
claims for category B device trials is required before payment can be
made. Once you have obtained the CMS approval letter, please forward a
copy to [email protected]
If these requirements are met, Medicare will base payment for Category
B devices on
Medicare’s payment for comparable approved devices.
After approving a manufacturer to conduct a clinical trial on the
device, the FDA assigns each investigational device an identification
code. This code, called the Investigation Device Exemption (IDE)
number, allows Medicare to consider payment for each device
separately. The IDE number is seven positions (one alpha and six
numeric Ex: A000000).
Effective for routine costs incurred on or after January 1, 2005,
Medicare will cover the routine costs of clinical trials involving
Investigational Device Exemption (IDE) Category A devices (used in the
diagnosis, monitoring, or treatment of an immediately life-threatening
disease or condition).
Prior to the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), the Centers for Medicare & Medicaid
Services (CMS) limited coverage of clinical trials to:
· IDE Category B trials (21 CFR 405.201); and
· Routine costs for qualifying clinical trials (National Coverage
Determinations (NCD)Manual 310.1).
The MMA (Section 731(b)) expands the ability of CMS to cover costs in
clinical trials by authorizing coverage of routine costs in certain
clinical trials involving IDE Category A devices effective for routine
costs incurred on or after January 1, 2005.
This extension of coverage refers to the routine services performed
for such a trial, and the Category A device itself remains
non-covered.
Category A (experimental/investigational) devices are innovative
medical devices about which the Food and Drug Administration (FDA) has
major questions regarding safety and effectiveness. For a trial to
qualify for payment of routine costs, it must meet certain criteria
established by the Secretary of the Department of Health and Human
Services to ensure that the trial conforms to appropriate scientific
and ethical standards.
In addition, the MMA established additional criteria for trials
initiated before January 1, 2010, to ensure that the devices involved
in these trials be intended for use in the:
1. Diagnosis;
2. Monitoring; or
3. Treatment of an immediately life-threatening disease or condition
(“a stage of a disease in which there is a reasonable likelihood that
death will occur within a matter of months or in which premature death
is likely without early treatment).
Providers participating in the clinical trial are responsible for
furnishing all information that Medicare Services deems necessary for
coverage determination and claims processing regarding:
1.
The device;
2.
The clinical trial; and
3.
The participating Medicare beneficiaries.
Remember: Routine costs are determined in the same manner as in
qualified trials under the NCD.
The provider must contact the local Medicare Contractor (MAC) before
billing for this service. Emails can be sent to www.ngsmedicare.com
and hard copies sent to the address below for Rhode Island:
National Government Services, Inc. (14411-A and B MAC)
Medical Director- Laurence Clark, MD
P.O.Box 7108
Indianapolis, IN 46207
We suggest you send the packet via certified mail, with a request for
signature on delivery. It is important that the research site maintain
copies of the letter to the director/contractor and its response in
the study files.
Be certain to request of the sponsor a copy of the FDA letter
notifying the company as to whether the product is a Category A or a
Category B device. All sponsors receive such a letter at the same time
the FDA notifies Medicare of the device categorization. No sponsor
should refuse or be reluctant to give this information to you. If the
sponsor refuses, do not agree to proceed with the trial unless they
agree to pay for trial care, so that you don’t risk billing Medicare
inappropriately.
What will be covered?
Medicare will pay for the investigational device and related services.
“Related Services” include all services furnished in preparation for
the use of an investigational device, services furnished along with
and necessary to the use of an investigational device and services
furnished as necessary aftercare that are incident to recovery from
the use of the device. Example: A surgical procedure to implant a
device is considered a related service.
Payment for investigational devices applies to both inpatient and
outpatient unless otherwise indicated as a restriction.
Deductibles and co-insurance apply. Reimbursement for a device is
limited to what Medicare would have paid for a comparable approved
device.
The hospital my accept an investigational device from a manufacturer
or research sponsor at no charge for use in a clinical trial. In such
cases, the hospital must not charge the patient or Medicare for the
device. When the hospital received the device “free” or at no charge,
the hospital may bill Medicare for services related to the use of the
device so long as the device meets all other Medicare coverage
requirements.
What isn’t covered?
*
Medical or hospital services related to the use of the device that
the insurer/contractor decides are not “reasonable or necessary”
*
Medical and hospital services related to the use of a device that
are excluded from coverage for other reasons (i.e., no benefit
category or a national non coverage determination exists for the
device comparable to the study device)
Helpful Links:
National and/or Local Coverage Determinations list
http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd
IDE Approved study list for CMS coverage
https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html
LORA 09062016