(Medicare Benefit Policy Manual)

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 Device s 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 Medicar e 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 Pharmacopoei a, 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 m an 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 requirem ents, 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) proce ss;   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 r esolved) 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 n otifies 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 benef iciaries (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 m et (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 questi on(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 Healths National Library of Medicines 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 st udy 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 instruc tions).   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 FDAs 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 a s 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 decisio n 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 f or 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