View
219
Download
1
Category
Tags:
Preview:
Citation preview
Columbia UniversityMedical Center
Columbia UniversityMedical Center
Research Billing Compliancepresented by
Office for Billing Compliance
Research Billing Compliancepresented by
Office for Billing Compliance
HISTORY
“Every human being of adult years and sound mind has a
right to determine what shall be done with his own body;
and a surgeon who performs an operation without his
patient’s consent, commits an assault, for which he is liable
in damages.”
Justice Benjamin Cardozo, New York Court of Appeals
Schloendorff v. Society of New York Hospital, 1914
General Requirements of
DHHS Title 45 Code of Federal Regulations-46 CFR 116 –
and
FDA Guidance - 21 CFR Part 50 - Subpart B
Informed Consent of Human Subjects
both state that: “No [clinical] investigator may involve a human being as a
subject in research […] unless the investigator has obtained
the legally effective informed consent from the subject or
subject’s legally authorized representative.”
Basic Elements of the Informed ConsentFederally supported human subject research must comply with all regulations and policies:
•45 CFR 46.116: Protection of Human Subjects – Department of Health and Human Services National Institutes of Health Office for Protection from Research Risks
•21 CFR 50.25: Protection of Human Subjects – Food and Drug Administration Department of Health and Human Services
Basic Elements of the Informed ConsentA statement that the study involves research
An explanation of the purpose of the research
The trial treatment(s), and
The probability for random assignment to each treatment
The trial procedures to be followed, including all invasive procedures
The subject’s responsibilities
Identification of any procedures which are experimental
A description of any reasonably foreseeable risks or discomforts
A description of any benefits which may be expected from the research
An explanation of alternative procedure(s) or course(s) of treatment available
A description of compensation and/or treatment in the event of a trial related injury
Basic Elements of the Informed ConsentThe anticipated prorated payment (if any) for participating in the study
An explanation of anticipated expenses (if any) for participating in the study
An explanation that participating in the trial is voluntary, and an explanation that the subject may withdraw from the trial at any time without penalty or loss of benefit
An explanation that access to original medical records must be granted
That identifying study records will be kept confidential
An explanation of whom to contact for answers to questions about the research
An explanation of why trial participation may be terminated
An explanation of the expected duration of the subject’s participation
The approximate number of subjects involved in the trial
Informed Consent is an extension of
the Principal Investigator’s study protocol
It is more than just a signature on a form.
It is an educational process of information
exchange and before a subject can be
enrolled in a clinical trial, that subject must
agree to participate
Informed Consent Regulations require the consent document to include a description of any additional costs to the patient that may result from participation in the research
These costs can include:
- Routine Services
- Investigational Devices
Additional CostsThe Responsibility for Payment of Additional Costsmay reside with:
• Sponsor – this can be»Government
»Industry
»Private
• Medicare
• 3rd Party Payors
• Patient / Study Subject
The NIH defines research patient care costs as:
“the costs of routine and ancillary services provided by hospitals to individuals participating in research programs”
Medicare has determined that usual patient care be defined as:
“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”
ROUTINE COSTS
On June 7, 2000, the President of the United States issued an executive memorandum directing the Centers for Medicare & Medicaid Services (CMS) to
"explicitly authorize [Medicare] payment for routine patient care costs...and costs due to medical complications associated with participation in clinical trials”
ROUTINE COSTS
ROUTINE COSTS
Medicare’s consent to pay for routine costs provided to patients enrolled in human subject research means that these services must be provided in accordance with the federal guidelines that govern payment for patient services
Including:
»Patient cost-sharing obligations
»Fraud and Abuse laws and regulations
ROUTINE COSTS
Medicare deemed criteria:
–Trials funded by NIH, CDC, AHRQ, CMS, DOD, and the VA
–Trials supported by centers or cooperative groups that arefunded by NIH, CDC, AHRQ, DOD, CMS, and the VA
–Trials conducted under an investigational new drugapplication (IND) reviewed by the FDA
–Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs.
ROUTINE COSTSRoutine costs DO include
(and are therefore covered)Routine costs do NOT include
(and are therefore are not covered)
Items or services that are typically provided absent a clinical trial (e.g. medically necessary conventional care)
Items and services required for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent)
Items and services required for the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications
Items and services that are medically necessary for the diagnosis or treatment of complications arising from the provision of an investigational item or service
The investigational item or service, itselfItems and services: --For which there is no Medicare benefit category, or -- Which are statutorily excluded, or -- That fall under a national non-coverageItems and services furnished solely to satisfy data collection and analysis needs 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 scans)Items and services customarily provided by the research sponsors free of charge for any enrollee in the trialItems and services provided solely to determine trial eligibility
ROUTINE COSTSInvestigational Drugs - Medicare covers routine costs
The Clinical Trial must
•Evaluate an item or service that falls into the Medicare benefit category and not have been statutorily excluded
•Have therapeutic intent or diagnostic intervention and all subjects must have the diagnosed disease (healthy volunteers are assigned proper control groups)
•Be deemed by Medicare and be:– Conducted under an IND application reviewed by the FDA, or
– Exempt from IND application under 21 CFR 312.2(b)(1)- which states that a trial is deemed until the qualifying criteria are developed and the certification process is in place
Sponsors of both IND trials and IND-exempt trials must identify themselves by email to: clinicaltrials@cms.hhs.gov
Investigational Devices
In 1996, Medicare coverage was expanded to include certain investigational medical devices and related medical procedures that are reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body member
FDA regulations generally allow sponsors to charge investigators for investigational devices and these costs can usually be passed on to the patients
Investigational Devices
Category A devices are not covered under Medicare as they do no satisfy the statutory requirement that Medicare pay for devices determined to be reasonable and necessary.
Category B devices may be covered under Medicare if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met
Investigational Devices
Medicare Coverage Criteria
•The device must be used within the context of an FDA approved clinical trial and according to approved patient protocols
•The device must follow established national or local policies for similar FDA approved devices
•The device must be medically necessary for the patient
•The device must be furnished in a setting appropriate to the patient’s medical needs and condition
Medicare Payment Criteria
•Applies to both inpatient and outpatient claims
•Deductible and coinsurance do apply
•Inpatient payment for the IDE is bundled into the DRG or non-PPS payment
Investigational Devices
Preparation for Reimbursement
The Principal Investigator must Provide Medicare with:
−A copy of FDA approval letter with approved IDE code number provided to the sponsor/manufacturer of the device
−Trade or common name of device and classification name
−Action taken to conform to any applicable IDE special controls
−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
−Indication of how device will be billed [ie: inpatient or outpatient]
−The name and social security numbers of all patients participating in the clinical trial
−The protocol for obtaining informed consents from study patients
Investigational Devices
Information supporting anticipated billing to Medicare for Investigational Devices should be submitted to:
Debi Reifsnyder
Education Specialist
Empire Medicare Services
PO Box 4846
Syracuse, NY 13202
Investigational Devices
The Medicare Prescription Drug, Improvement,
and Modernization Act of 2003: Implications for
Medical Device and Medical Equipment
Manufacturers
Investigational DevicesOutline of the New Coverage
Effective January 1, 2005
• Routine costs associated with Category A trials will be covered if the device is determined to be for use in:
-the diagnosis, the monitoring, and the treatment of an immediately life threatening disease or condition
• Device must be a Category A device
• Trials must meet criteria established by CMS(appropriate scientific and educational criteria)
Office For Billing ComplianceResearch Billing Compliance
Debra Fitzpatrick305-0571
IRBGeorge Gasparis, Director
305-5883http://www.cpmcirb.hs.columbia.edu/root/main.htm
MEDICARE-Centers for Medicare and Medicaid (CMS)
http://www.cms.hhs.gov/medlearn/refctmed.asp?#coverage
-Empire Medicare (Local Medicare Carrier)http://www.empiremedicare.com/
-
Recommended