June 7, 2000: The President of the United States issued an executive memorandum directing Centers for Medicare & Medicaid Services (CMS) to “explicitly authorize [Medicare] payment for routine patient care and costs due to medical complications associated with participation in clinical trials." Medicare covers the routine costs of qualifying clinical trials, as such costs are defined in National Coverage Determination (NCD) 310.1, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply. The definition of a routine cost excludes the investigational item or service, itself, unless otherwise covered outside of the clinical trial.
September 19, 2000: CMS implemented its initial Clinical Trial Policy through the NCD process--NCD for Routine Costs on Clinical Trials (310.1)
April 7, 2008: CR 5805 implemented to change HCPCS Modifiers used when billing clinical trials and CR 5790 implemented that requires the voluntary submission of an 8-digit clinical trial number on claims.
As a result of the activities noted in the timeline above Medicare will cover the routine costs of qualifying clinical trials and the reasonable and necessary items and services to diagnose and treat complications arising from the participation in ALL clinical trials.
Effective for items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.
Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial except:
The investigational item or service, itself unless otherwise covered outside of the clinical trial;
Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and
Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.
Routine costs in clinical trials include:
Items or services that are typically provided absent a clinical trial (e.g., conventional care);
Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications.
This policy does not withdraw Medicare coverage for items and services that may be covered according to local coverage determinations (LCDs) or the regulations on category B investigational device exemptions (IDE) found in 42 CFR 405.201-405.215, 411.15, and 411.406. For information about LCDs, refer to the Medicare Coverage Database, a searchable database of Medicare contractors' local policies.
For non-covered items and services, including items and services for which Medicare payment is statutorily prohibited; Medicare only covers the treatment of complications arising from the delivery of the non-covered item or service and unrelated reasonable and necessary care. However, if the item or service is not covered, by virtue of a national non-coverage policy in Publication 100-03 NCD Manual and is the focus of a qualifying clinical trial, the routine costs of the clinical trial (as defined above) will be covered by Medicare but the non-covered item or service, itself, will not.
November 6, 2014: Change Request (CR) 8921 was released by CMS with finalized changes effective on and after January 1, 2015, to Medicare coverage requirements and review procedures related to items and services in Food and Drug Administration (FDA) approved Category A and B IDE studies. CR8921 makes changes to the following Medicare manuals:
“Medicare Benefit Policy Manual,” Chapter 14;
“Medicare Benefit Policy Manual,” Chapter 16, Section 10; and
“Medicare Claims Processing Manual,” Chapter 32, Section 68.
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 must submit a request for review and approval to CMS. Revised Chapter 14 of the “Medicare Benefit Policy Manual” contains detailed instructions on seeking CMS approval of Category A and B IDE studies for purposes of Medicare coverage. Additional information regarding submission of Category A and B IDE study review requests, along with the list of CMS-approved studies is available on the CMS Coverage Website.
Category A and B IDE studies APPROVED by the FDA before January 1, 2015, will continue to be submitted to Novitas for review and approval using our Submission Requirements and Submission Checklist.
IDE studies approved by Novitas prior to January 1, 2015, will continue to be administered by Novitas. Study sponsors do not have to submit the protocol to CMS if the participating study investigator sites have already received approval from Novitas. Study sponsors should continue to follow the process established by Novitas for any site additions or protocol changes.
Medicare claims for routine care items and services related to Category A or B IDE studies and Category B IDE devices, whether approved by the FDA before or after January 1, 2015, should continue to be submitted to Novitas that will identify routine costs for which Medicare payment is made for each related claim.
The official instruction, CR8921, was issued to Novitas regarding this change, via two transmittals. The first updates the “Medicare Claims Processing Manual”. The second updates the “Medicare Benefit Policy Manual”.
MLN Matters Article Number MM8921 is also available for review on the CMS website.
November 1, 1995: Medicare coverage was expanded to allow coverage for certain medical devices that are being studied as part of a FDA approved clinical trial but have not yet been approved for marketing. Under this policy, CMS and the FDA have established a more precise mechanism for classifying devices that may be undergoing clinical trials and determining if these devices are eligible for Medicare coverage. These documents are available at the U.S. Food and Drug Administration web site.
The U.S. FDA recognizes three regulatory classes of medical devices—Class I, Class II, and Class III.
Class I devices are things that have minimal potential for harm and subject only to general controls.
Class II devices are subject to general controls and special controls because general controls by themselves are not sufficient to assure safety and effectiveness.
Class III devices are those for which insufficient information exists to establish the safety and effectiveness of the device through the general and specific control process. These devices are those that sustain or support life, are implanted into patients, or present a risk of illness or injury.
Category A IDE Device
Category A devices are considered experimental and are NOT covered by Medicare under the IDE request process. They are novel and represent first-of-their-kind technologies. Their safety and effectiveness has NOT been established by the FDA; they are Class III devices.
Medicare covers ONLY the routine costs of clinical trials that involve Category A IDE devices that are incurred on or after January 1, 2005; the cost of the device itself still remains non-covered. In addition the Medicare Prescription Drug, Improvement, and Modernization ACT
§731 (b) established criteria for trials initiated before January 1, 2010 to ensure that those devices involved in the clinical trials are intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. A life-threatening disease or condition is defined as, “A state 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.”
If the associated services in a clinical trial in which a Category IDE A is used meet the requirements for a qualified clinical trial, then the associated services of that trial may be covered.
Category B IDE
Category B devices are newer generations of proven devices (Class I, Class II or Class III) for which the questions of safety and effectiveness have been proven. The device can only be considered for use if it is part of a FDA and Institutional Review Board approved study. Medicare covers Category B devices under the IDE request process if they are considered reasonable and necessary AND if all other applicable Medicare coverage requirements are met. A request for approval of a Category B must be submitted to the contractor for review and determination of coverage eligibility (see requirements for that submission below). After the review by the contractor, it may be found that the Category B IDE does not meet all of the requirements and therefore will not be covered.