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University HealthSystem Consortium Medicare Coverage Billing for Clinical Research: Definitions, Requirements Authorities

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University HealthSystem Consortium Medicare Coverage Billing for Clinical Research: Definitions, Requirements Authorities
Medicare Coverage & Billing for Clinical Research: Definitions, Requirements & Authorities
TOPIC
DEFINITION/REQUIREMENT
AUTHORITIES
DEFINITIONS
“Approved Study”
“Clinical Research”
“Deemed Study”
“Device”
“Drug”
“Humanitarian Use
Device” (“HUD”)
“Humanitarian Device
Exemption” (“HDE”)
“IDE” required
NOT DEFINED Term introduced with new Q0 and Q1 modifiers
PROPOSED ONLY. CURRENT JULY 2007 CTP does NOT include definition of clinical research: “Clinical
Research” means any systematic investigation involving human participants which is designed to contribute to
generalizable knowledge and which involves a clinical intervention, care delivery strategy, or diagnostic technique
designed to potentially improve predefined health outcomes”
• funded by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Agency for
Healthcare Research and Quality (AHRQ), CMS, Department of Defense (DoD), and the Department of Veterans
Affairs (VA);
• supported by centers or cooperative groups funded by the NIH, CDC, AHRQ, CMS, DoD and VA;
• conducted under an investigational new drug application (IND) reviewed by the FDA; or
• a drug trial exempt from the need for an IND under 21 C.F.R. § 312.2(b)(1).
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.
• "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles
(other than food) intended to affect the structure or any function of the body of man or other animals”
• a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects
or is manifested in fewer than 4,000 individuals in the United States per year.”
• An HDE is an application that is similar to a PMA application, but is exempt from the effectiveness requirements
of sections 514 and 515 of the Food, Drug, and Cosmetic Act (the Act). FDA approval of an HDE authorizes an
applicant to market a HUD, subject to certain profit and use restrictions set forth in section 520(m) of the Act.
HUDs cannot be sold for profit except in narrow circumstances and they can only be used in a facility after an
IRB has approved their use in that facility, except in certain emergencies.
An investigational device exemption (IDE) is required to do the following:
• Investigate (in a clinical study) an unapproved “significant risk” device. [The majority of IDE studies are
conducted to collect safety and effectiveness data used to support a Premarket Approval (PMA) applications].
• Investigate a legally marketed device for a new indication.
1
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
•
•
Transmittal 1418 (CR 5805) Jan. 18, 2008
July 19, 2007 Proposed Decision Memorandum
(CAG-00071R2)
•
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
•
• FD&C Act, sec. 201(h), 21 USC 321(h)
[Definitions]
•
FD&C Act, sec. 201(g)(1), 21 USC 321(g)
•
•
21 CFR 814.3(n) [PreMarket Approval Definitions]
FDA Draft Guidance for HDE Holders (Aug 2008)
•
See generally 21 CFR Part 812
TOPIC
“IDE Exempt”
“Immediately Life
Threatening”
“Investigational new
drug”
“IND Exempt”
“Medically indigent”
DEFINITION/REQUIREMENT
Device studies exempt from IDE regulations generally include:
• Pre-1976 devices
• Investigations conducted with legally marketed devices (e.g.510(k) cleared and HDE- or PMA-approved), if
used in accordance with the approved labeling (May include consumer preference testing of marketed
device or combinations of legally marketed devices)
• Studies using in vitro diagnostics labeled for “research purpose only” as per regulations 21 CFR 809.10(c) and if
the testing: (1) is non-invasive, (2) does not require invasive sampling procedures that present significant risk;
(3) does not introduce energy into a subject; AND (4) is not used as a diagnostic procedure without
confirmation by another medically established diagnostic product or procedure
• custom devices (narrowly defined)
• foreign studies; declaration of Helsinki
“a stage of the 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.” [NOTE: CMS guidance indicates that CMS has adopted
the FDA definition of “immediately life threatening” ]
Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also
includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and
"investigational new drug" are deemed to be synonymous
(p) The term "new drug" means
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the
composition of which is such that such drug is not generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the
condition prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so
recognized shall not be deemed to be a "new drug" if at any time prior to the enactment of this Act [enacted June
25, 1938] it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling
contained the same representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the
composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness
for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations,
been used to a material extent or for a material time under such conditions.
(b) Exemptions. (1) The clinical investigation of a drug product that is lawfully marketed in the United States is
exempt from the requirements of this part if all the following apply:
(i) The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication
for use nor intended to be used to support any other significant change in the labeling for the drug;
(ii) If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation
is not intended to support a significant change in the advertising for the product;
(iii) The investigation does not involve a route of administration or dosage level or use in a patient population or
other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use
of the drug product;
(iv) The investigation is conducted in compliance with the requirements for institutional review set forth in part 56
and with the requirements for informed consent set forth in part 50; and
(v) The investigation is conducted in compliance with the requirements of§ 312.7.
Patients whose health insurance coverage, if any, does not provide full coverage for all their medical expenses and
that their medical expenses, in relationship to their income, would make them indigent if they were forced to pay
full charges for their medical expenses
2
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
AUTHORITIES
•
21 CFR 812.2(c)
•
•
MLN Matters #MM354 July 3, 2005
21 CFR Sec. 812.36 [Definition of Immediately
life threatening]
FD&C Act, sec. 201(h), 21 USC 321(h)
•
•
21 CFR 312.2(b)(1) [Exemptions to
Investigational new drug requirements]
•
MLN Matters #SE0822, September 30, 2008*
TOPIC
“Qualified Study”
DEFINITION/REQUIREMENT
Meets “3 Requirements” and is “deemed” to have 7 “highly desirable characteristics”
AUTHORITIES
•
•
“3 Reqirements”
“7 highly desirable
characteristics”
“related to”
• Evaluates a Medicare Benefit — The subject or purpose of the trial must be the evaluation of an item or
service that falls within a Medicare benefit category (e.g., physicians’ service, durable medical equipment,
diagnostic test) and is not statutorily excluded from coverage (e.g., eyeglasses or hearing aids).
• Has a Therapeutic Intent — The trial must be intended to test an item or service intended to help patients
(e.g., it is not solely to measure toxicity or disease pathology).
• Enrolls Diagnosed Beneficiaries — Trials of therapeutic interventions must enroll patients with diagnosed
diseases rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to
have a proper control group.
• The principal purpose of the trial is to test whether the intervention potentially improves the participants’ health
outcomes.
• The clinical trial:
o is well-supported by available scientific and medical information or is intended to clarify or establish the health
outcomes of interventions already in common clinical use;
o does not unjustifiably duplicate existing studies;
o is appropriately designed;
o is sponsored by a credible organization or individual capable of successfully executing the proposed trial; and
o complies with federal regulations regarding human subjects.
• All aspects of the trial are conducted according to the appropriate standards of scientific integrity.
NOT Defined by statute or regulation. Following are examples of services “related to” and “not related to”
noncovered services while the beneficiary is an inpatient:
• A beneficiary was hospitalized for a noncovered service and broke a leg while in the hospital. Services related to
care of the broken leg during this stay is a clear example of “not related to” services and are covered.
• A beneficiary was admitted to the hospital for covered services, but during the course of hospitalization became a
candidate for a noncovered transplant or implant and actually received the transplant or implant during that
hospital stay. When the original admission was entirely unrelated to the diagnosis that led to a recommendation for
a noncovered transplant or implant, the services related to the admitting condition would be covered.
• A beneficiary was admitted to the hospital for covered services related to a condition which ultimately led to
identification of a need for transplant and receipt of a transplant during the same hospital stay. If, on the basis of
the nature of the services and a comparison of the date they are received with the date on which the beneficiary is
identified as a transplant candidate, the services could reasonably be attributed to preparation for the noncovered
transplant, the services would be “related to” noncovered services and would also be noncovered.
3
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
•
•
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
•
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
• Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
•
•
60 Fed Reg 48417, 4820 (Sept. 19, 1995)
Medicare Benefit Policy Manual (Pub. 100-2), Ch.
16, sec.180 [Services Related to and Required as
a Result of Services Which Are Not Covered
Under Medicare]
TOPIC
“routine costs”
“Significant Risk
Device”
“Therapeutic Intent”
“Usual Patient Care”
DEFINITION/REQUIREMENT
AUTHORITIES
Routine costs include 3 components:
• 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
noncovered 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.
Routine Costs EXCLUDE:
• 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.
Significant risk device means an investigational device that:
(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for
serious risk to the health, safety, or welfare of a subject;
(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise
preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of
a subject; or
(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
NOT DEFINED IN WRITING In an audio conference held by the AHLA on February 22, 2006, representatives
from CMS “strongly encouraged” providers to discuss therapeutic intent for non-device trials with the local Medicare
administrative contractors prior to implementation in instances where an institution cannot make this determination
on its own. Note, however, CMS noted that so long as therapeutic intent is within the objectives of the protocol, an
institution may find that there is support for a finding of therapeutic intent. Some Medical directors have indicated
that therapeutic intent must be found in a “primary objective” or “major objective”, others seem to be willing to
accept therapeutic intent in any of the objectives.
Usual patient care is “the care which is medically reasonable, necessary, and ordinarily furnished (absent any
research programs) in the treatment of patients by providers under the supervision of physicians as indicated by the
medical condition of the patients.”
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
• Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
“(w)here…research is conducted in conjunction with or as a part of the care of patients, the costs of usual patient
care are reimbursable to the extent such costs are not met by research funds”
•
•
•
•
•
21 CFR Sec. 812.3(m)
FDA Overview of Significant Risk vs NSR Devices
FDA Information Sheet Guidance (SR vs NSR,
including examples)
•
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
•
•
•
Medicare Provider Reimbursement Manual, Pub.
15-1, Ch. 5, sec 502.2
Medicare Provider Reimbursement Manual, Pub.
15-1, Ch. 5, sec. 504.1
NIH Grants Policy Statement (03/01) Research
Patient Care Costs
GENERAL COVERAGE PRINCIPLES
Item or service fits a
Medicare Benefit
Category
The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit
category (e.g., physicians' service, durable medical equipment, diagnostic test)
•
•
•
•
•
4
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
SSA sec. 1812 [Part A], 42 USC 1395d
SSA sec. 1832 [Part B], 42 USC 1395k
See generally Medicare Benefit Policy Manual,
Pub. 100-2
TOPIC
DEFINITION/REQUIREMENT
AUTHORITIES
Item or service is
reasonable and
necessary
A provider must only bill for reasonable and necessary medical services
•
SSA sec.1862(a)(1)(A), 42 USC 1395y(a)(1)(A)
Item or service is not
statutorily excluded
from Medicare
Coverage
The subject or purpose of the trial must not be statutorily excluded from coverage (e.g., cosmetic surgery, hearing
aids).
•
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
See 42 CFR sec. 411.15 for list of excluded
services
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
16, sec. 20 [Services not reasonable &
necessary]
42 CFR sec. 405.207 [Services related to NonCovered Device]
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
14, sec. 80
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
16, sec. 180
“No payment may be made under Part A or Part B for any expenses incurred for items or service … which … are not
reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a
malformed body member”
•
•
•
Item or service is not
related to a non
covered item/service
Medical and hospital services are sometimes required to treat a condition that arise as a result of services that are
not covered because they are determined to be not reasonable and necessary or because they are excluded from
coverage for other reasons. Services “related to” noncovered services (e.g., cosmetic surgery, noncovered organ
transplants, noncovered artificial organ implants, etc.), including services related to follow-up care and
complications of noncovered services which require treatment during a hospital stay in which the
noncovered service was performed, are not covered services under Medicare. Services “not related to”
Medicare Coverage
for Drugs and
Biologicals
used On-Label
Medicare Coverage
for Drugs and
Biologics
used OFF-Label
noncovered services are covered under Medicare.
Medicare generally covers drugs that are approved for inclusion in the following treatises: United States
Pharmacopoeia National Formulary (SUP-NF), the United States Pharmacopoeia-Drug Information (USD-DI), or the
American Dental Association (ADA Guide to Dental Therapeutics, excluding certain drugs unfavorably evaluated in
the ADA Guide to Dental Therapeutics. The extent of coverage depends on the part (Part A, Part B, Part D) of the
Medicare program that applies to the use of the drug or biological
• Medicare Part A generally covers drugs that are “ordinarily furnished by the hospital for the care and treatment
of inpatients”. Use must be “safe and effective” and otherwise “reasonable and necessary.” Drugs approved for
marketing by the FDA are considered “safe and effective” when used for indications specified on the labeling.”
Use of FDA-Approved drug or biological is covered if:
o
It was injected on or after the date of FDA’s approval;
o
It is reasonable and necessary for the individuals patient; and
o
All other applicable coverage requirements are met.
• Medicare Part B generally covers drugs that are NOT usually “self-administered,” and that are furnished either
(i) by a hospital to an outpatient “incident to” a physician service, or (ii) by a physician (or the physician’s office
staff) to a patient “incident to” a physician’s service.
•
Exceptions to Part B’s “self-administered” coverage restrictions are made for anti-cancer drugs and
accompanying anti-emetics, and for immunosuppressive drugs needed by transplant recipients
• Off label uses of drugs. Off-label uses of drugs may be covered if the Medicare Contractor determines the use
to be medically acceptable taking into consideration major drug compendia, authoritative medical literature
and/or accepted local standards of medical practice.
• Unlabeled use for anti-cancer. Medicare may cover if the off-labeled drug or regimen of drugs if it is listed in
one of the recognized compendia and not listed as “not indicated” in any of the compendia or if the use is
supported by clinical research that appears in peer-reviewed medical literature.
5
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
•
•
•
•
•
•
•
•
•
SSA Sec. 1861(t)(1)
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
1, sec. 30 [Drugs and Biologicals]
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
15, sec. 50.1 [Definition of a drug or biologic]
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
15, sec. 50.2 [Determining self-administration of
Drug or Biological]
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
15, sec. 50.4 [Reasonableness and Necessity]
Medicare-Anti-Cancer Compendia info (SSA 1861
(t)(2))
• SSA sec 1927(k)(2), 2 USC 1396r-8
• SSA sec. 1861(s)(2)(A) & (B) 42 USC sec 1395x
•
•
•
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
15, sec. 50.4.2 [Unlabeled Use of Drug]
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
15, sec. 50.4.5 [Unlabeled Use of anti-Cancer
drugs]
Medicare-Anti-Cancer Compendia info (SSA 1861
(t)(2))
TOPIC
Medicare Part D
Coverage for Drugs
and Biologics
State Mandated
Coverage for Drugs in
certain clinical trials
Research Costsallowable costs
DEFINITION/REQUIREMENT
• Medicare Part D generally covers drugs that may be dispensed only upon a prescription and that are approved
by the FDA or exempted from the FDA approval process
A growing number of states have passed legislation or instituted special agreements requiring health plans to pay
the cost of routine medical care received as a participant in a clinical trial.
For example: The Michigan Consensus Agreement requires private insurance plans, HMOs and the Michigan
Medicaid Program to cover Phase II and III cancer clinical trials that are sponsored or approved by any one of the
following:
• National Institutes of Health (NIH)
• National Cancer Institute
• U.S. Food and Drug Administration
• U.S. Department of Defense
• U.S. Department of Veterans Affairs
• Centers for Medicare and Medicaid Services
• Centers for Disease Control and Prevention
The agreement also covers any side effects from the clinical trial treatment, including hospitalization costs.
• Coverage for Phase I trials is under consideration.
(a) Principle. Costs incurred for research purposes, over and above usual patient care, are not includable as
allowable costs.
(b) Application.
(1) There are numerous sources of financing for health-related research activities. Funds for this purpose are
provided under many Federal programs and by other tax-supported agencies. Also, many foundations, voluntary
health agencies, and other private organizations, as well as individuals, sponsor or contribute to the support of
medical and related research. Funds available from such sources are generally ample to meet basic medical and
hospital research needs. A further consideration is that quality review should be assured as a condition of
governmental support for research. Provisions for such review would introduce special difficulties in the Medicare
programs.
(2) If research is conducted in conjunction with, and as a part of, the care of patients, the costs of usual patient
care and studies, analyses, surveys, and related activities to serve the provider’s administrative and program needs
are allowable costs in the determination of payment under Medicare.
6
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
AUTHORITIES
•
SSA Sec. 1860D-2, 42 USC 1395w-102
•
NCI: States Requiring Health Plans to Cover
Patient Care Costs in Clinical Trials
State Example: Michigan Working Group to
Improve Cancer Outcomes
•
•
42 CFR sec. 413.90
TOPIC
FDA on Devices
DEFINITION/REQUIREMENT
Medicare coverage of a device is related to the FDA’s determination that the device is “safe and effective”. The FDA
determines whether a product is safe and effective as a condition of approval while CMS determines if the device is
reasonable and necessary as a condition of coverage for the Medicare population.
• The Food, Drug and Cosmetic Act requires a manufacture of medical devices to notify the FDA of its intent to
market a medical device. (Premarket Notification “PMN” or 510(k))
• The FDA determines whether new device is “substantially equivalent” to device marketed prior to passage of
Medical Device Amendments of 1976 to Food, Drug & Cosmetic Act.
o If FDA determines device is substantially equivalent, it may be marketed immediately and is regulated in the
same class as the equivalent device
o If not substantially equivalent, clinical testing and premarket approval is required for a new device, unless the
device is reclassified into a lower class. Once the studies are completed, the sponsor continues with the PMA
application process. A PMA application approved by the FDA permits the applicant to market the device
commercially.
• 3 classes of Medical Devices exist: Class I (General Controls—subject to least regulatory control, e.g. bandages,
gloves); Class II (Special Controls—must meet certain performance standards or special controls developed by
fed, e.g. powered wheelchairs, infusion pumps), Class III (Pre-Market Approval—including life-supporting, lifesustaining or implantable devices or devices that present potentially unreasonable risk of illness or injury. A
Class III device must undergo a pre-market approval process that includes scientific review to ensure the safety
and effectiveness of the device)
• Applicants must support a Pre-market Approval (PMA) application with clinical data demonstrating the safety
and effectiveness of the device. FDA may issue an investigational device exemption (IDE) that permits the
device to be used in a clinical study in order to develop safety and efficacy data.
• Clinical investigations of IDE devices must be conducted according to the FDA’s IDE regulations.
o Investigational devices subject to IDE regulations are classified as either “significant risk” or “nonsignificant
risk”
o IDE devices are further classified as either Category A or Category B
ƒ Category A (Experimental/Investigational) Novel, “first of kind” experimental investigational devices for
which the initial questions of safety and effectiveness of the device have not been proven
ƒ Category B (Nonexperimental and/or investigational) devices believed to be in classes I or II or devices
believed to be in Class III where the incremental risk is the primary risk in question (i.e., underlying
questions of safety and effectiveness have been resolved)
• Certain clinical investigations of devices (i.e. lawfully marketed devices) are exempt from the IDE regulations
7
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
AUTHORITIES
•
FDA Overview of Device Regulations
•
US FDA/CDRH: Device Advice - Device Classes
•
42 CFR Sec. 405.201 [Definition/Categorization
of Class I, Class II and Class III devices]
•
•
FDA IDE Overview
21 CFR sec. 812.3(m) [Definition of Significant
Risk Device]
21 CFR sec. 812.36 [Treatment use of an
Investigational Device]
•
•
21 CFR sec 812.2(c) [Exemption to IDE regs]
TOPIC
Medicare Coverage of
Devices
Local Contractor
review of clinical trial
services
DEFINITION/REQUIREMENT
•
•
•
Category A devices-CMS does not cover Category A devices under Medicare because they do not satisfy the
statutory requirement that Medicare pay for devices determined to be reasonable and necessary.
• Category B devices- CMS may cover Category B devices if they are considered reasonable and necessary and if
all other applicable Medicare coverage requirements are met. Local contractor must apply the following criteria
when making coverage determinations on FDA-approved IDE Category B devices:
o The device must be used within the context of the FDA-approved clinical trial;
o The device must be used according to the clinical trial’s approved patient protocols;
o There may be an established national policy as contained in existing manual instructions, e.g., National
Coverage Determinations Manual instructions, etc.;
o In the absence of national policy, there may be a local policy for similar FDA-approved devices;
o There may be position papers or recommendations made by national and/or local specialty societies.
Contractors should also consider, among other factors, whether the device is:
o Medically necessary for the particular patient and whether the amount, duration, and frequency of use or
application of the service are medically appropriate; and
o Furnished in a setting appropriate to the patient’s medical needs and condition.
• Local contractors are directed to “not develop new or revised LMRPs for clinical trial services. Clinical trial
services that meet the requirements of the NCD are considered reasonable and necessary.”
•
Local contractors must consider whether any restrictions concerning site of service, indications for use, or any
other list of conditions for coverage have been placed on a device’s use.
•
Coverage with
Evidence
Development
AUTHORITIES
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 IDE Category B devices; and
• Hospital Institutional Review Board (IRB) approved IDE devices
Investigational Devices
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.
If the item or service is not considered “reasonable & necessary” under section 1862(a)(1)(A), it may still be
considered for coverage under Section 1862(a)(1)(E), which is the basis for CMS’ Coverage with Evidence
Development (CED). Section 1862(a)(1)(E) is linked to Section 1142 of the Social Security Act, which allows CMS to
work jointly with the Agency for Healthcare Research and Quality (AHRQ) to evaluate and empower CMS to pay for
the clinical costs of research. The purpose of CED is to generate data on the utilization and impact of the item or
service evaluated in the NCD, so that Medicare can (1) document the appropriateness of use of that item or service
in Medicare beneficiaries under current coverage; (2) consider future changes in coverage for the item or service;
and (3) generate clinical information that will improve the evidence base on which providers base their
recommendations to Medicare beneficiaries regarding the item or service.
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© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
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•
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Medicare Benefit Policy Manual, Pub. 100-2, Ch
14, sec. 10 [Coverage of Medical Devices]
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
14 sec. 20 [FDA Approval Investigational Device
Exemptions (IDEs)]
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
14 sec. 30 [Coverage of FDA approved IDEs]
SSA 1862(m) [Coverage for routine costs
associated with certain clinical trails of Category
devices]
42 CFR sec 405.201 [Definitions]
42 CFR sec. 405.203 [FDA categorization of
investigational devices]
42 CFR sec. 405.205 [Coverage for Nonexperimental/investigational Category B device]
42 CFR sec. 405.209 [Payment for Cat B device]
45 CFR sec. 211 [Procedures for Contractors
Making Coverage Decisions for Cat B devices]
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 69.4 [Local Medical Review Policy]
42 CFR sec. 405.211(c) [Procedures for
Contractors in making coverage decisions for a
non-experimental/investigational (Cat B) device]
42 CFR sec. 405.215 [Confidential commercial
and trade secret information]
SSA 1862(a)(1)(E)
CMS Guidance on Coverage with Evidence
Development [including coverage with Clinical
study participation (“CSP”)]
CMS-Coverage with Evidence Development
[Includes links to approved CED studies]
TOPIC
CHARGES
Waiving Charges for
routine care provided
in a clinical trial (no
evidence of
indigency)
Waiving charges for
routine care provided
in a clinical trial for
“indigent” patients
Waiving charges for
co-pays related to
clinical trial items or
services
Setting Charges for
an Investigational
Drug
Setting charges for
an Investigational
Device
DEFINITION/REQUIREMENT
If the routine costs of the clinical trial are furnished gratuitously (i.e., without regard to the beneficiary’s ability to
pay and without expectation of payment from any other source), then Medicare payment cannot be made and the
beneficiary cannot be charged. If private insurers deny the routine costs and the provider of services does not
pursue the non-Medicare patients for payment after the denials (even though the non-Medicare patient has
the ability to pay), Medicare payment cannot be made and the beneficiary cannot be charged for the routine costs.
If the routine costs of the clinical trial are not billed to indigent non-Medicare patients because of their inability to
pay (but are being billed to all the other patients in the clinical trial who have the financial means to pay even when
his/her private insurer denies payment for the routine costs), then a legal obligation to pay exists. Therefore,
Medicare payment may be made and the beneficiary (who is not indigent) will be responsible for the applicable
Medicare deductible and coinsurance amounts.
If a research sponsor offers to pay cost-sharing amounts owed by the beneficiary (such as co-pays), this could be a
fraud and abuse problem [particularly for industry sponsored studies]
(d) Charging for and commercialization of investigational drugs –
• (1) Clinical trials under an IND. Charging for an investigational drug in a clinical trial under an IND is not
permitted without the prior written approval of FDA. In requesting such approval, the sponsor shall
provide a full written explanation of why charging is necessary in order for the sponsor to undertake or continue
the clinical trial, e.g., why distribution of the drug to test subjects should not be considered part of the normal
cost of doing business.
• (2) Treatment protocol or treatment IND. A sponsor or investigator may charge for an investigational drug for a
treatment use under a treatment protocol or treatment IND provided: (i) There is adequate enrollment in the
ongoing clinical investigations under the authorized IND; (ii) charging does not constitute commercial marketing
of a new drug for which a marketing application has not been approved; (iii) the drug is not being commercially
promoted or advertised; and (iv) the sponsor of the drug is actively pursuing marketing approval with due
diligence. FDA must be notified in writing in advance of commencing any such charges, in an information
amendment submitted under 312.31. Authorization for charging goes into effect automatically 30 days after
receipt by FDA of the information amendment, unless the sponsor is notified to the contrary.
• (3) Noncommercialization of investigational drug. Under this section, the sponsor may not commercialize an
investigational drug by charging a price larger than that necessary to recover costs of manufacture, research,
development, and handling of the investigational drug.
• (4) Withdrawal of authorization. Authorization to charge for an investigational drug under this section may be
withdrawn by FDA if the agency finds that the conditions underlying the authorization are no longer satisfied.
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:
***
(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than
that necessary to recover costs of manufacture, research, development, and handling.
9
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© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
AUTHORITIES
•
•
MLN Matters #SE0822, September 30, 2008*
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
16, sec. 40 [No Legal Obligation to Pay or
Provide for Services]
•
•
MLN Matters #SE0822, September 30, 2008*
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
16, sec. 40 [No Legal Obligation to Pay or
Provide for Services]
•
•
MLN Matters #SE0822, September 30, 2008*
Medicare Benefit Policy Manual, Pub. 100-2, Ch.
16, sec. 40 [No Legal Obligation to Pay or
Provide for Services]
OIG Advisory Opinion 08-11 [Lott Study]
OIG Advisory Opinion 04-01 [BARI 2D Study]
OIG Advisory Opinion 02-16 [ACCORD Study]
OIG Advisory Opinion 00-5 [NETT Study]
21 CFR 312.7 [Promotion and charging for
investigational new drugs]
•
•
•
•
•
•
21 CFR sec. 812.7 [Prohibition of Promotion and
other practices]
TOPIC
No-Cost items
Placing Sponsor
Covered Charges on
the Claim form
DEFINITION/REQUIREMENT
• providers cannot bill Medicare for items provided free of charge by the sponsor
• In most cases, institutional providers [hospitals] are required to bill a no cost item due to system edits that will
ensure that an item (received at no cost or not) is billed along with an associated services (e.g., a device/drug
must be reported along with an implantation/administration). To report a no cost items, institutional providers
must place a token charge in the “Non-Covered” charge field for the no cost item.
• Outpatient hospitals billing “no cost” devices must append the -FB modifier to the procedure code for
implanting the “no cost” device, along with the appropriate condition code (in Table 1 above-BUT NOTE--no
code applicable to research). The modifier will identify the procedure code line for the “no cost” device,
while the condition code will explain the reason why the device was provided free of cost.
• Practitioners [physician] providers should not bill for no cost items as there is no ”Non-Covered” charges field on
the claims and there are also no [CMS] system edits in place to require providers to do so.
• Items and services provided free of charge by research sponsors may not be billed to be paid by Medicare, and
providers are not required to submit the charge to Medicare. If it is necessary for a provider to show the items
and services that are provided free of charge in order to receive payment for the covered routine costs (e.g.
administration of a non-covered chemotherapeutic agent), providers are instructed to submit such charges as
“non-covered” at the time of entry, while also assuring that the beneficiary is not held liable. By doing so, the
provider is accomplishing 4 things:
o communicating to the contractor that the provider is not seeking reimbursement for the no cost items; and
o reflecting, with completeness and accuracy, all services provided to the patient; and
o preventing the line item or claim from being rejected/denied by system edits that require an item to be billed
in conjunction with an associative procedure (such as implants or administrations); AND
o assuring that the patient and provider are not held liable for any charges for the no cost item.
AUTHORITIES
•
•
SSA sec 1862(a)(2)
Medicare Claims Processing Manual, Ch. 32, sec.
67 [No Cost Items]
•
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 67.1 and 67.2 [Practitioner and
Institutional billing for No Cost items]
•
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
Medicare Claims Processing Manual, Pub. 100-4,
Ch.
32,
sec.
69.3
[Medical
Records
Documentation Requirements]
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 69.5 [Billing Requirements General]
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare National Coverage Determinations
Manual, Pub. 100-03, Ch. 1, Part 4, sec. 310
[Clinical Trials]
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 69.6 [Billing Requirements for
Clinical Trials]
DOCUMENTATION AND CLAIM REQUIREMENTS
CRB Medical Record
Documentation
Requirements
The billing provider must include in the beneficiary's medical record the following
information: trial name, sponsor, and sponsor-assigned protocol number. This information does not need to be
submitted with the claim but must be provided if requested for medical review.
•
•
Separate Line Items
General Routine Care
Claim Requirements
Practitioners &
Suppliers
Physicians and hospitals should enter clinical trial and non-clinical trial services on separate line items when billing
both types of services on the same claim
For Qualified studies:
• V70.7 [Examination of participant in clinical trial] is required as primary diagnosis if healthy control. If subject
is not a healthy control place the V70.7 as the secondary diagnosis and the service will be processed as “a
therapeutic clinical trial service.”
• Modifier Q1
10
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© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
•
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•
TOPIC
DEFINITION/REQUIREMENT
AUTHORITIES
General Routine Care
Claim Requirements
Institutional
Providers
For Qualified studies:
• Condition code 30 (qualifying clinical trial) is reported at the claim level
• Modifier ‘Q1’ (only for institutional outpatient claims)
• V70.7 [Examination of participant in clinical trial] is required as the secondary diagnosis.
ƒ
V70.7
Means “examination of participant in clinical trial”
“do not submit claims with diagnosis code V70.7, unless there are covered charges, and they represent routine
patient care”
•
ƒ
•
Modifier Q0
Cat A or Cat B devices. Practitioner/suppliers must bill a Q0 modifier [“Investigational clinical service provided in a
clinical research study that is in an approved clinical research study”) along with the IDE number
“The use of this [Q0] modifier indicates that the provider is certifying FDA approval of a clinical trial for the device.”
•
•
•
Modifier Q1
Modifier Q1 [“Routine clinical service provided in a clinical research study that is in an approved clinical research
study”] is line item specific and must be used to identify items and services that constitute [1] medically necessary
routine patient care or [2] treatment of complications arising from a Medicare beneficiary’s participation in a
Medicare covered clinical trial. When billed in conjunction with the V70.7 diagnosis code, the Q1 modifier will serve
as the provider’s attestation that the service meets the Medicare coverage criteria (i.e., was furnished to a
beneficiary who is participating in a Medicare qualifying clinical trial and represents routine patient care, including
complications associated with qualifying trial participation).
•
•
Condition Code 30
Requirement for institutional providers (only) to use Condition Code 30 on a claim level for qualified clinical trials
•
See also
Revenue Code 624
and IDE # in Device
section below
8-digit Registry
Number
[see Investigational Device Section Below]
•
Medicare Advantage
Not currently required, however, effective for clinical trial claims received after April 1, 2008, (regardless of date
of service) providers can begin to report an 8 digit clinical trial number
Covered clinical trial services furnished to beneficiaries enrolled in managed care plans shall be paid in accordance
with applicable fee for services rules
11
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© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
•
July 9, 2007 National Coverage Decision Routine
Costs in Clinical Trials ("CTP")
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 69.6 [Billing Requirements for
Clinical Trials]
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 69.6 [Billing Requirements for
Clinical Trials]
A14637 Riverbend Article. Billing for Clinical
Trials and IDEs (Oct. 10, 2003)
Transmittal 1418 (CR 5805) Jan. 18, 2008
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, secs. 68.3 [Cat A], 68.4 [Cat B], 69.6
[Billing Requirements for Clinical Trials]
ML Matters #MM5805 (Jan 18, 2008) [New
Healthcare Common Procedure Coding System
(HCPCS) Modifiers when Billing for Patient Care
in Clinical Research Studies]
Transmittal 1418 (CR 5805) Jan. 18, 2008
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, secs. 68.3 [Cat A], 68.4 [Cat B], 69.6
[Billing Requirements for Clinical Trials]
ML Matters #MM5805 (Jan 18, 2008) [New
Healthcare Common Procedure Coding System
(HCPCS) Modifiers when Billing for Patient Care
in Clinical Research Studies]
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 69.6 [Billing Requirements for
Clinical Trials]
• MLN Matters #5790 (April 7, 2008) CR5790,
Related CR Transmittal R10OTN
• CMS Transmittal 310 (CR 5790) Jan 18, 2008
• Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 69.6 [Billing Requirements for
Clinical Trials]
• Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 69.9 [Processing Fee For Service
Claims for Covered Clinical Trial Services
Furnished to Managed Care Enrollees]
TOPIC
INVESTIGATIONAL DEVICES
DEFINITION/REQUIREMENT
AUTHORITIES
Writing to
Contractors for
Approval of IDE
studies
Providers that participate in an IDE trial and anticipate filing Medicare claims must notify the Medicare contractor
prior to a submission of a claim for payment. Providers shall notify their contractor of the Category A IDE
device trial before billing routine costs of clinical trials involving a Category A device, as listed in Section 68.2
above.
•
IDE Study materials
required by
Contractors (Example
from Part A, National
Government
Services)
Electronic submission of
• A non-redacted copy of the FDA-approval letter provided to the sponsor or manufacturer of the device. The
approved IDE code number must be on the letter.
• [per 68.2, name of the device [both trade, common or usual, and classification name]
• A copy of the IRB-approved protocol [or, per 68.2, a brief summary of the study design].
• A description of any action(s) taken to conform to any applicable IDE special controls
• A narrative description of the device sufficient to make a payment determination.
• A statement indicating how the device is similar to and/or different from other comparable products.
• The protocol for obtaining informed consent from the beneficiary(ies) participating in the trial.
• Description of any items or services for which the providers (hospital / physicians) are being reimbursed by the
sponsor.
• Copies of at least two supporting scientific articles (full texts) for the investigational device and its
intended indication published in peer reviewed literature are also required.
• [per 68.2, an indication of whether the device will be billed on an inpatient or outpatient claim]
Cat A device must be intended for diagnosis monitoring or treatment of “immediately life-threatening
disease/condition.” Upon receiving the required information for the trial, the contractor will determine if the
Category A device, as used in the trial, is intended for the diagnosis, monitoring, or treatment of an immediately
life-threatening disease/condition. If the contractor determines that the device does, in fact, meet the requirements
of coverage, then the provider may begin billing the routine costs of a clinical trial involving a Category A device.
(so long as study is initiated prior to January 1, 20100)
In addition to billing the routine costs, providers must identify the line for which the Category A IDE device is being
billed.
•
Specific Cat A device
Study Requirements
•
•
•
•
•
•
Revenue Code 624
Cat A: Institutional providers must “bill” Cat A device involved in a clinical trial by placing the Cat. A IDE Number on
a 0624 (IDE) revenue code line, with the charges for the device placed in the “Non-covered” charges field.
•
Cat B: Institutional providers must bill the Category B IDE Number on a 0624 revenue code line with charges in the
covered charges field (providers receiving the device free of charge must bill the IDE charges as non-covered).
•
12
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
Medicare Claims Processing Manual, Pub. 100-4
Ch. 32, Sec. 68.2 [Notifying Contractors of an
IDE Trial], Sec. 68.3 [Billing Requirements for
Providers Billing Routine Costs of Clinical Trials
Involving a Category A IDE]
Medicare Claims Processing Manual, Ch. 32, Sec.
68.2 [Notifying Contractors of an IDE Trial,
Updated Dec. 2007]
Investigational Device Exemptions: Dec. 2007
Sample Form from National Government Services
69 Fed Register 66334 (Nov. 15, 2004) Preamble
commentary implementing MMA Sec. 731
[Coverage of Routine Costs for Category A
Clinical Trials]
MLN Matters #MM3548 (January 1, 2005)
CMS Transmittal 131 (Dec. 17, 2004)
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 68.3 [Billing Requirements for
Providers Billing Routine Costs of Clinical Trials
Involving a Category A IDE]
CMS FAQ No 5142 “What are the billing
instructions for costs covered by clinical trials
involving Investigational Device Exemption (IDE)
Category A devices?” (Updated 8/29/08)
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 68.3 [Billing Requirements for
Providers Billing Routine Costs of Clinical Trials
Involving a Category A IDE]
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, sec. 68.4 [Billing Requirements for
Providers Billing Routine Costs of Clinical Trials
Involving a Category B IDE]
TOPIC
IDE #
DEFINITION/REQUIREMENT
As a requirement for Category B IDE coverage, providers must bill a six-digit IDE Number that begins with a “G”
(i.e., G123456).
Physicians billing electronically must place the IDE number on the 2300 Investigational Device Exemption Number
REF segment, data element REF02 (REF01=LX) of the 837p claim format. If billing on the CMS-1500 paper form,
the IDE number must be in Item 23
Hospitals billing electronically must place the IDE number on 2300 Investigational Device Exemption Number REF
Segment, data element REF02 (REF01=LX) of the 837i claim format. If billing on the CMS-1450 paper form, the IDE
number must be in Form Locator 43
PMA #
Currently, in order to receive reimbursement for procedures performed as part of a carotid
artery stenting post-approval study, providers must include the FDA-issued PMA number
on each claim to indicate participation in a specific study.
Billing Post Approval Studies is similar to normal Category B IDEs billing procedures, except that under Post
Approval coverage, providers must bill the Pre-Market Approval (PMA) number assigned to the stent system by the
FDA. PMA numbers are like typical IDE Numbers in that they have six digits, but they begin with a “P” (i.e.,
P123456) instead of “G.”
AUTHORITIES
•
•
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, secs. 68.3, 68.4. & 160.1
[Billing
Requirements for Providers Billing Routine Costs
of Clinical Trials Involving a Category A, Category
B IDE, or Category B PTA study]
CMA FAQ No 5142 “What are the billing
instructions for costs covered by clinical trials
involving Investigational Device Exemption (IDE)
Category A devices?” (Updated 8/29/08)
•
Medicare Claims Processing Manual, Pub. 100-4,
Ch. 32, secs. 68.3, 68.4. & 160.1 [Post-approval
study coverage]
•
CMS Final Decision for Clinical Trial Policy - Q&As
(Oct. 17, 2007)
•
FDAAA (Public Law 110-85)
NON-QUALIFIED STUDIES
CMS re: what to do
with items and
services in NonQualified studies
„ Q4: How does CMS address the perception among the public and some Medicare contractors that
privately funded studies were not subject to the deeming process established by the 2000 policy?
„ A4. We understand that the current clinical trial policy has led to some confusion on this point. Trials that do not
meet the existing criteria for deemed trials should contact their local Medicare contractors to determine whether
items and services will be covered in that geographic area.
STUDY REGISTRATION
Registration
Requirements
• The Food and Drug Administration Modernization Act (FDAMA) of 1997 resulted in the establishment of
ClinicalTrials.gov and mandated registration of FDA-regulated efficacy drug trials for serious or life-threatening
diseases and conditions.
• Since 2005, many, if not most, medical journals began to require prospective public registration of certain
clinical trials as a prerequisite for publication. Included among them, for example are the International
Committee of Medical Journal Editors (ICMJE) member journals, including JAMA & New England Journal of
Medicine
• The Food and Drug Administration Amendments Act (FDAAA) of 2007 expanded the scope of clinical trials that
must be registered, requires registration information that was previously optional, adds a few additional
registration data elements, requires eventual inclusion of trial results information, and provides penalties for
noncompliance
13
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© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
TOPIC
DEFINITION/REQUIREMENT
Registration of Which
Studies?
Collectively, the FDAMA, FDAAA, and ICMJE requirements cover the following types of studies:
• Controlled clinical investigations of drugs and biologics subject to FDA regulation, other than Phase I
trials.
• Controlled trials with health outcomes of devices subject to FDA regulation (other than small feasibility
studies) and pediatric postmarket surveillance.
• Any research project that prospectively assigns human subjects to intervention and concurrent control or
comparison groups in order to study the cause-and-effect relationship between a medical intervention
and a health outcome.
• Clinically directive trials - those that test a clinical hypothesis about health outcomes, including all trials
whose primary purpose is to affect clinical practice
Some journals have additional specifications for which studies must be registered. For example, JAMA requires
registration of all randomized clinical trials (RCTs), except for Phase I trials, that "randomize" human research
participants to an intervention.
For ICMJE publication:
• Before beginning subject enrollment*
• Note: The ICMJE requirement is more stringent than the FDAAA requirement (below) for timing of
registration relative to patient/subject enrollment.
For FDAAA compliance:
• December 26, 2007 or 21 days after the first patient is enrolled* -- for trials initiated after 9/27/2007,
or trials that are ongoing as of 12/26/2007
• September 27, 2008 - for trials that were ongoing as of 9/27/2007 and do not involve a "serious or
life-threatening disease or condition"
•
Exception - Trials that (1) were ongoing as of 9/27/2007, (2) do involve a "serious or life threatening
disease or condition", and (3) are completed by 12/26/2007, are not subject to the FDAAA requirements,
but are likely to be subject to the pre-existing FDAMA registration requirements. For purposes of this
exception, the "completion date" is the date the final subject was examined or received an intervention
Registration of
Studies by when?
Registration of
Studies by Whom?
for the purposes of final collection of data for the primary outcome.
Sponsored clinical trials are likely to be registered on ClinicalTrails.gov by the lead sponsor (the clinical trial
agreement negotiated through DRDA may specify who is responsible). Clinical trials conducted under an FDA IND or
IDE are likely to be registered by the IND or IDE holder. Otherwise, trial registration falls to the study investigator.
Before investigators register a sponsored trial, they should search the ClinicalTrials.gov website to be sure that the
trial has not already been registered
AUTHORITIES
NOT-OD-08-023: Clinical Trials Registration in
ClinicalTrials.gov (Public Law 110-85): Competing
Applications and Non-Competing Progress Reports
NOT-OD-08-023: Clinical Trials Registration in
ClinicalTrials.gov (Public Law 110-85): Competing
Applications and Non-Competing Progress Reports
•
•
ClinicalTrials.gov
ClinicalTrials.gov Protocol Registration System
Info
•
42 USC sec. 1395y(b)(2)(A) [Medicare Secondary
Payor]
42 CFR sec. 411.20(a)
GENERAL OBLIGATIONS & PROHIBITIONS
Medicare Secondary
Payor
Medicare Secondary Payor laws prohibit Medicare payment (excluding conditional payments) for an item/service
where payment “has been made, or can reasonably be expected to be made under . . . [a primary plan] liability
insurance policy or plan (including a self-insured plan) . . .
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© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
•
TOPIC
Prohibition on
making false
statements or
misrepresentations of
material facts
concerning requests
for payment under
Medicare
Prohibition on
making false
statement or
misrepresentation of
material facts
concerning requests
for payment under
[Michigan] Medicaid
State all payor false
claims Statutes
Prohibition on
knowingly and
willfully soliciting or
receiving or offering
or paying
remuneration in
exchange for
referrals/generation
of federal healthcare
business
DEFINITION/REQUIREMENT
AUTHORITIES
A provider shall not knowingly or with “deliberate ignorance” or “reckless disregard” make false statements or
misrepresentations of material facts concerning requests for payment under Medicare
•
42 USC sec. 1320a-7b(a) [making or causing to
be made false statements]
[Most states now have Medicaid false claims statutes with obligations and penalties at least as strong as the federal
false claims statute]
(1) A person shall not make or present or cause to be made or presented to an employee or officer of this state a
claim under the social welfare act, Act No. 280 of the Public Acts of 1939, as amended, being sections 400.1 to
400.121 of the Michigan Compiled Laws, upon or against the state, knowing the claim to be false.
(2) A person shall not make or present or cause to be made or presented a claim under the social welfare act, Act
No. 280 of the Public Acts of 1939, which he or she knows falsely represents that the goods or services for which
the claim is made were medically necessary in accordance with professionally accepted standards. Each claim
violating this subsection shall constitute a separate offense. A health facility or agency shall not be liable under this
subsection unless the health facility or agency, pursuant to a conspiracy, combination, or collusion with a physician
or other provider, falsely represents the medical necessity of the particular goods or services for which the claim
was made.
(3) A person who violates this section is guilty of a felony, punishable by imprisonment for not more than 4 years,
or by a fine of not more than $50,000.00, or both.
Many states have statutes prohibiting false claims for all payors
(1) A person shall not make or present or cause to be made or presented to a health care corporation or health
care insurer a claim for payment of health care benefits knowing the claim to be false.
(2) A person shall not make or present or cause to be made or presented to a health care corporation or health
care insurer a claim for payment of health care benefits which he or she knows falsely represents that the goods or
services were medically necessary in accordance with professionally accepted standards. Each claim which violates
this subsection shall constitute a separate offense. A health facility or agency shall not be liable under this
subsection unless the health facility or agency, pursuant to a conspiracy, combination, or collusion with a physician
or other provider, falsely represents the medical necessity of the particular goods or services for which the claim
was made.
(3) A person shall not knowingly make or cause to be made a false statement or false representation of a material
fact to a health care corporation or health care insurer for use in determining rights to health care benefits. Each
claim which violates this subsection shall constitute a separate violation.
A person shall not knowingly or willfully offer or pay any remuneration (including any kickback, bribe, or rebate)
directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person—
(A) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for
which payment may be made in whole or in part under a Federal health care program, or
(B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility,
service, or item for which payment may be made in whole or in part under a Federal health care program
•
MCL 400.607 [MI Medicaid False Claims Act]
•
MCL 752.1003 [MI Health care False Claims Act]
•
•
SSA sec. 1128B(b)
42 USC sec. 1320a-7b(b) [Illegal remuneration]
15
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
[see also list of advisory opinions under prohibition
on inducing Medicare/Medicaid beneficiaries.]
TOPIC
Prohibition on Billing
No Cost Items
Prohibition on Double
Billing.
DEFINITION/REQUIREMENT
AUTHORITIES
Providers are not to seek reimbursement from Medicare for no cost items
•
SSA sec. 1862(a)(2) [No legal obligation to pay]
On occasion, providers may receive an item (such as a device or drug) that is offered by a manufacturer/supplier
free of charge. Such items, for purposes of these instructions, are considered “no cost items.” Providers are not to
seek reimbursement for no cost items as noted in Section 1862(a)(2) of the Social Security Act.
A hospital or physician may not bill Medicare and simultaneously bill a liability insurer (or assert or maintain a
lien against the beneficiary’s liability insurance settlement) [or another source of payment, such as a sponsor
Sample CMS references to “double billing”
• Cases without medical need for replacement would be considered double billing.
• Collecting from a beneficiary [or other source such as sponsor] where full payment is made on a bundled basis
would constitute double billing.
•
Medicare Claims Processing Manual, Ch. 32, sec.
67 [No Cost Items]
•
CMS Transmittal 332 Oct. 22, 2004 [Policy and
Refinements on Billing Noncovered Charges to the
FI]
Medicare Claims Processing Manual, Pub. 100-04,
Ch. 1, Sec. 60.4.6 [Clarification on notice
requirements related to billing “bundled” noncovered institutional benefits]
MLMatters #SAE0424 [Clarification on Billing
LVADs]
SSA sec. 1128A(a)(5) 42 USC 1320a-7a
OIG Advisory Opinion 08-11 [Lott Study]
OIG Advisory Opinion 04-01 [BARI 2D Study]
OIG Advisory Opinion 02-16 [ACCORD Study]
OIG Advisory Opinion 00-5 [NETT Study]
Joint Commission standard RI.1.10, element of
performance 5
•
•
Prohibition on
inducing Medicare or
Medicaid
Beneficiaries
In the absence of financial need, offering a Medicare or Medicaid beneficiary “remuneration” may violate the
“beneficiary inducement statute” where the person offering the remuneration knows or should know that the
remuneration is “likely to influence” the beneficiary to order or receive items or services from a particular provider.
Remuneration includes waiver of cost sharing obligations
Hospital Obligation
for Ethical Billing
Hospital providers are required to follow “ethical behavior” in their care treatment, and services and business
practices. Hospital providers are to provide patients with information about charges for which they
will be responsible
•
•
•
•
•
•
GENERAL RESEARCH AUTHORITIES
Protection of Human
Subjects
Financial Disclosure
by Clinical
Investigators
Institutional Review
Boards
Prohibitions related
to Investigational
devices
21 CFR Sec. 50 [Protection of Human Subjects]
21 CFR Sec. 54 [Financial Disclosure by Clinical
Investigators]
21 CFR Sec. 56 [Institutional Review Boards]
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:
(a) Promote or test market an investigational device, until after FDA has approved the device for commercial
distribution.
(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than
that necessary to recover costs of manufacture, research, development, and handling.
(c) Unduly prolong an investigation.
If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be
justified or in the case of a class II device that it will not comply with an applicable performance standard or an
amendment to that standard, the sponsor shall promptly terminate the investigation.
(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.
16
2001 Spring Road · Suite 700 · Oak Brook, Illinois 60523-1890 · phone 630.954.1700 · fax 630.954.4730 · www.uhc.edu
© 2008 University HealthSystem Consortium. All rights reserved [VERSION 3].
21 CFR sec. 812.7 [Prohibition of Promotion and
other practices]
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