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  6. MOU 225-16-004
  1. Domestic MOUs

MOU 225-16-004

I.           Purpose
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare &Services (CMS) as part of the Department of Health and Human Services (HHS), all United States Federal Government entities and hereinafter also referred to as "agencies.” The agencies enter this agreement in order to streamline and facilitate the efficient categorization  of investigational medical devices in order to support CMS's  ability to make Medicare coverage determinations for those investigational devices under 42 C.F.R. 405.201, et seq..
CMS is committed to strengthening and modernizing the nation's health care system to provide access to high quality care and improved health. CMS is focused on measurably improving care and population health by transforming the U.S. health care system into an integrated and accountable delivery system that continuously improves care, reduces unnecessary costs, prevents illness and disease progression, and promotes health.
FDA is a regulatory agency responsible for protecting the public health through the regulation of food, cosmetics, tobacco, and medical products, including drugs, biological products, animal drugs, and medical devices. FDA administers the Federal Food, Drug and Cosmetic Act (see 21 U.S.C. § 321 et seq.) and applicable sections of the Public Health Service Act (see e.g. 42 U.S.C. § 262), among other statutes. Among its duties, the FDA approves pre-market applications, conducts inspections of manufacturing facilities, and monitors post-marketing adverse events.
II.           Authority
CMS enters into this MOU in furtherance of its responsibility to make coverage determinations for items and services for Medicare beneficiaries under part B, pursuant to 42 U.S.C. § and 42 CFR 405.201, et. seq.
FDA enters into this MOU in furtherance of its responsibility to regulate the investigational use of devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of devices, which falls under the umbrella of the Investigational Device Exemption (IDE). See 21 U.S.C. § 360j(g); 21 CFR Part 812.
FDA and CMS also enter into this MOU under the authority of 21U.S.C. § 393(c), which directs the Secretary of HHS to implement programs and policies that foster collaboration between FDA and other science-based  Federal agencies to enhance the scientific and technical expertise available to the Secretary in the conduct of duties with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies.
III.          Background
In 1995, the CMS and FDA entered into an interagency agreement in which FDA agreed to categorize investigational devices for purposes of making Medicare coverage decisions. CMS has taken into account the FDA categorization as part of its determination of which devices meet the requirements for Medicare coverage under section 1862(a)(1)(A) of the Social Security Act (the "reasonable and necessary" clause).
In December 2013, CMS published a final rule in which it modified its regulations related to Medicare coverage of routine care items and services in Category A IDE studies and trials and Medicare coverage of Category B IDE devices and routine care items and services. 42 C.F.R. §405.211; 78 Fed. Reg. 74,230, 74,809 (Dec. 10, 2013).Medicare may cover any device that FDA categorizes as B. See 42 CFR § 405.211(b). By contrast, Medicare does not pay for any device that FDA categorizes as A. 42 C.F.R. §405.211(a). CMS established these scientific and ethical standards for clinical trials consistent with its authority under section 1862(m)(2)(B) and section 1871 of the Social Security Act. CMS also informed the public that as of January I, 2015, IDE coverage decisions for IDE clinical trials would be made by CMS centrally, rather than by Medicare Administrative Contractors. 78 Fed. Reg. at 74,432.
IV.          Purpose
FDA and CMS need to revise their shared understanding regarding investigational device categorization to reflect the changes in the 2013 CMS IDE regulation. See 78 Fed. Reg. at 74,809. Rather than amending the 1995 interagency agreement between the agencies, FDA and CMS have decided to enter into a Memorandum of Understanding (MOU). This MOU will cancel and replace the 1995 interagency agreement upon the effective date.
V.           Substance of the Agreement-Program Areas and Responsibilities/Activities
a.            For the purpose of assisting CMS in determining Medicare coverage, FDA will place all devices with FDA-approved applications for IDE into either Category A (Experimental)or Category B (Nonexperimental/Investigational).
FDA will classify investigational devices under the definitions set forth at 42 C.F.R. § 405.201.
Category A (Experimental) device 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.
Category B (Nonexperimental/lnvestigational)device 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.
b.              Each Federal partner will establish a principal point of contact to facilitate the actions carried out under this MOU.
c.             FDA and CMS agree to attend an initial meeting to establish the specific procedures and safeguards consistent with the regulations that are necessary to implement this MOU. The initial meeting will take place within 60 days of signing and approval of this MOU. Periodic meetings will be scheduled thereafter on an as needed basis.
VI.          Effect on Existing Statutes and Regulations
FDA and CMS will take actions under this collaboration that are consistent with existing statutes and regulations, and that nothing in the MOU shall be construed as changing the current requirements under the statutes and regulations administered and enforced by FDA and CMS including but not limited to:  Title 42 of the United States Code, the Public Health Service Act, and the Federal Food, Drug, and Cosmetic Act. Further, nothing contained in this MOU constitutes a mandate or a requirement imposed on FDA or CMS that is additional to the mandates or requirements imposed on FDA or CMS by Federal statutes and regulations.
IDE Regulatory Approval Request
Investigations covered under the IDE regulations at 21 CFR part 812 are subject to differing levels of regulatory control depending upon the level of risk. The IDE regulations distinguish between significant risk and non-significant risk device studies; non-significant risk studies are generally considered to have FDA approval as long as certain abbreviated requirements are met. See 21 CFR 812.2(b). Some types of studies are exempt from the IDE regulations. See 21 CFR 812.2(c). The following regulations pertain to device investigations: 21 CFR parts 50, 54, 56, 58, 812, and 820.30.
VII.         Assessment Mechanisms
FDA and CMS staff involved in implementing the MOU will provide regular and consistent oversight and reevaluation of all terms and conditions contained herein.
VIII.       Terms, Termination or Modification
This MOU becomes effective 6 months after the signature of both the FDA and CMS and will remain in effect for an indefinite period, unless otherwise terminated. This agreement may be modified by unanimous consent or terminated by any party upon 60 days written notice. This agreement may be modified by consent of both Federal partners or terminated by any party immediately upon written notice in the event that a Federal statute is enacted or a regulation is issued by a Federal partner that materially affects this MOU.
IX.           Principal Points of Contact
Centers for Medicare &Medicaid Services:
Rosemarie Hakim, Ph.D.
Coverage & Analysis Group
Centers for Medicare &Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
(410) 786-3934
U.S. Food and Drug Administration:
Owen Faris, Ph.D.
Center for Devices and Radiological Health
U.S. Food Administration
WO66/Rm 1522 
10903 New Hampshire Avenue
Silver Spring, MD 20993
(301) 796-6356
Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
December 1, 2015
Jeffrey Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
December 2, 2015 


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