Transcript Challenges in Clinical Research Trials

Challenges in
Clinical Research Trials
Christee G. Laster
Smith Moore Leatherwood LLP
1180 W. Peachtree St. NW, Suite 2300
Atlanta, Georgia 30309
T (404) 962-1052
F (404) 962-1257
[email protected]
© 2011 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
PREVIEW
• Regulatory/Enforcement Framework
• Research Billing
• Fraud and Abuse Concerns
• Recent Enforcement Actions
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Regulatory Framework
Primary responsibility for regulation of clinical trials
rests with agencies of the U.S. Department of
Health and Human Services (HHS).
These are:
Office for Human Research Protections (OHRP)
Office of Civil Rights (OCR)
Food and Drug Administration (FDA)
Office of Research Integrity (ORI)
National Institutes of Health (NIH)
Centers for Medicare and Medicaid Services (CMS)
Over-arching regulatory concern:
Protection and well-being of human subjects.
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Regulatory/Enforcement
Framework
Three FDA centers regulate medical investigational
products for human use:
These are:
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
FDA’s Office of Regulatory Affairs (ORA) conducts onsite
bioresearch monitoring inspections of sponsors, PIs and IRBs
Enforcers: OIG/DOJ/FBI/State AGs/Health Care Fraud
Prevention and Enforcement Action Team
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PAYMENT FOR CLINICAL TRIALS
Research Billing
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PAYMENT
PAYMENTFOR
FORCLINICAL
CLINICALTRIALS
TRIALS
Medicare Coverage for Clinical Trials
CMS NCD 310.1: The Clinical Trial Policy
• CMS created the NCD in September 2000 (in response
to Pres. Clinton’s Executive Order) to help Medicare
beneficiaries participate more fully in clinical research.
-There were two reconsiderations (06/07) with final
revision effective July 2007.
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PAYMENT
PAYMENTFOR
FORCLINICAL
CLINICALTRIALS
TRIALS
Medicare Coverage for Clinical Trials
• NCD 310.1 states that Medicare will cover “routine costs of
qualifying clinical trials...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.” -NCD for Routine Cost in Clinical trials (310.1)
• Many commercial payers follow Medicare.
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PAYMENT FOR CLINICAL TRIALS
States That Require Health Plans to
Cover Patient Care Costs in Clinical Trials
Taken from the National Cancer Institute website, March 2011
http://www.cancer.gov/clinicaltrials/education/laws
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PAYMENT FOR CLINICAL TRIALS
Medicare will cover routine costs of “qualified” clinical trials. Study is
“qualified” if meets the desirable 7:
1. The principal purpose of the trial is to test whether the intervention
potentially improves the participants’ health outcomes;
2. The trial is well-supported by available scientific and medical information or
it is intended to clarify or establish the health outcomes of interventions already
in common clinical use;
3. The trial does not unjustifiably duplicate existing studies;
4. The trial design is appropriate to answer the research question being asked in
the trial;
5. The trial is sponsored by a credible organization or individual capable of
executing the proposed trial successfully;
6. The trial is in compliance with Federal regulations relating to the protection
of human subjects; and
7. All aspects of the trial are conducted according to the appropriate standards
of scientific integrity.
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PAYMENT FOR CLINICAL TRIALS
A study may be “deemed qualified” if:
Funded by NIH, CDC, AHRQ, CMS, DOD, and
VA;
Supported by centers/cooperative groups funded by
these agencies;
Subject to review by FDA under IND application;
or
 IND exempt under 21 CFR § 312.2(b)(1).
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PAYMENT FOR CLINICAL TRIALS
Routine costs are those items and services that would ordinarily be
provided to beneficiaries and covered by Medicare. However, the
NCD includes additional items that may be covered, including:
Conventional care (items or services typically provided absent a
clinical trial);
Items or services required solely for the provision of the
investigational service or item (e.g. administration of non-covered
chemotherapeutic agent);
Items or services needed for reasonable and necessary care
arising from the provision of the investigational service or item –
particularly for the diagnosis or treatment of complications.
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PAYMENT FOR CLINICAL TRIALS
Routine costs Do Not include the following:
Items which are statutorily excluded or for which there is a noncoverage decision;
Investigational item or service itself, unless otherwise covered
outside of the clinical trial;
Items and services used solely to meet data collection and
analysis requirements (e.g., monthly CT scans for a condition
usually requiring only a single scan); and
Items and services customarily provided free of charge by the
sponsor.
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PAYMENT FOR CLINICAL TRIALS
Medicare Coverage for Medical Devices
The NCD clinical trials policy does not address
device studies. Institutions/sites should work with
their Medicare Contractor to determine coverage of
all device studies.
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PAYMENT FOR CLINICAL TRIALS
Medicare Coverage for Medical Devices:
•Devices approved through FDA pre-market
approval process
•Devices cleared through FDA 510(k) process
•FDA-approved IDE Category B devices
•IRB-approved medical devices
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PAYMENT FOR CLINICAL TRIALS
Medicare IDE Regulations:
• IDE device billing rules are found at 42 CFR §§
405.201-215, 411.15. and 411.406.
•The Medicare process for coverage of category B
IDEs is outline in Medicare Benefit Policy Manual
Chapter 14.
• The rules address coverage of Category A & B
devices and the routine care related to each IDE
device.
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PAYMENT FOR CLINICAL TRIALS
Medicare IDE Regulations:
• Category A Devices: not covered
• Category B Devices: may be covered if
approved by the Contractor
• What about items/services provided for the
device?
• “Routine care services related to a [Category B]
device that is furnished in conjunction with an
FDA approved clinical trial” 405.407(b)(3)
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PAYMENT FOR CLINICAL TRIALS
CMS Modifiers for Research have changed:
•CMS requires the use of particular HCPCS modifiers for billing in clinical
research. The modifiers are used to identify investigational and routine clinical
services provided in research studies.
•CMS has discontinued the following HCPCS modifiers as of December 31, 2007:
QA (FDA IDE), QR (Item or Service Provided in a Medicare Specified Study), and
QV (Item or Service Provided as Routine Care in a Medicare QCT).
•Effective for dates of service after 01/2008, the following new modifiers are used
solely to differentiate between routine and investigational clinical services:
•Q0 – Investigational clinical service provided in an approved;
•Q1 – Routine clinical service provided in an approved clinical research
study.
See, CMS Transmittal 1418,
https://www.cms.gov/transmittals/downloads/R1418CP.pdf
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PAYMENT FOR CLINICAL TRIALS
Common Billing Errors:
• Billing for services not rendered
• Billing Medicare (or other payers) for free
items/services
• Billing for non-reimbursable items/services
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PAYMENT FOR CLINICAL TRIALS
MEDICARE COVERAGE ANALYSIS
• A MCA is a review of clinical research items, services, procedures
and Medicare billing rules to determine the appropriate payer for
each item or service.
• Use of MCA and billing rules mitigates the primary compliance risk
and provides most defined standards for research billing.
• Properly performed MCA can be used for budget development, to
support contract negotiations, and for billing compliance.
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COMPLIANCE
Fraud and Abuse
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COMPLIANCE:FRAUD
FRAUD AND
AND ABUSE
COMPLIANCE:
ABUSE
January, 2011:
“We are pleased to have reached a settlement agreement
with the DoJ that fully resolves the post-market study
matter ... the company maintains that its post-market
studies and registries are legitimate clinical studies
designed to gather important scientific data ... the company
entered into a settlement agreement to avoid the potential
costs and risks associated with litigation.”
-Spokesperson for St. Jude Medical
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COMPLIANCE: FRAUD AND ABUSE
St. Jude Medical Investigation: Post-market
studies
• (Allegedly) conducted 3 post-market studies and a device
registry in which participating physicians were paid for each
St. Jude pacemaker and implantable cardiac device used (up to
$2000/pt).
• Research data was collected, but primary purpose was to
increase device sales by soliciting new users of the product or
converting physicians from competitor’s product.
$16 Million Settlement
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COMPLIANCE: FRAUD AND ABUSE
Medical device and pharmaceutical companies can
use post-market studies legitimately to obtain
information about how their products work in the
field, but they cannot use those studies, and the
honoraria associated with them, to induce physicians
to select their products.
-Government’s response
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COMPLIANCE: FRAUD AND ABUSE
The Big 3:
False Claims Act
Stark Law
Anti-Kickback Statute
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COMPLIANCE:
FRAUD
AND ABUSE
False Claims
Act
False Claims Act:
• Prohibits filing or causing the filing of false claims,
or creating a false record to get a claim paid.
• The core of a false claims case is that the
government was cheated in one form or another -the “false claim.”
• Typically occurs in research by double billing or
improper or unnecessary billing.
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COMPLIANCE:
FRAUD
AND ABUSE
False Claims
Act
False Claims Act:
As of Jan. 4, 2011, there were 1,341 qui tam cases under
investigation. Of these cases, 885 involve healthcare
fraud. A total of 180 qui tam cases are under seal that
allege pharmaceutical pricing and/or marketing
violations. An additional 80 cases involve hospital
fraud.
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COMPLIANCE: FRAUD AND ABUSE
• Pre-determine:
– Who is performing which service
– Who is responsible for payment for each
service (MCA)
– Identifying patients as research participants
(particularly for hospitals providing services)
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COMPLIANCE:
FRAUD
AND ABUSE
Anti-Kickback
Statute
Anti-Kickback Statute:
Prohibits paying, offering to pay, or receiving payment
in exchange for the referral of services or devices that
are covered under a federal health care program.
(PP)ACA: Kickback violations result in FCA violations
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COMPLIANCE:
FRAUD
AND ABUSE
Anti-kickback
Statute
Kickback violations often arise:
•
•
•
•
•
Post-market/data registry studies
Waivers of co-payments and deductibles
Inducements for future purchases, referrals
Off-label promotions
Investigator promotions
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COMPLIANCE: FRAUD AND ABUSE
Stark Law:
Prohibits referrals (and any related billing) of
designated health services by a physician to an
entity in which the physician or an immediate
family member has a financial interest
(compensation/ownership).
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COMPLIANCE: FRAUD AND ABUSE
Stark Law:
• Violations often arise when physician is not an
employee of the hospital – any contracts for research
services must take into account the Stark law
exceptions or risk the ability to refer DHS to the
hospital (even for DHS unrelated to the research).
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Recent Enforcement/Settlement Actions
•Company made payments to physicians through clinical trials to
induce physicians to prescribe off-label.
•Company promoted psychiatric drug for unapproved uses by
recruiting physicians to author articles about studies physicians did
not conduct.
•Paying illegal remuneration to health care professionals recruited to
conduct studies for unapproved uses.
•Company conducted clinical trials of medical device w/out FDA
authorization.
•Independent physician researcher conducted sham clinical study.
•Investigator quoted in magazines promoting an IND.
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COMPLIANCE: FRAUD AND ABUSE
Settlements:
• Criminal and Civil fines ranging from $24M to
$600M
• CIAs with specific obligations addressing researchrelated activities
• Payments to be disclosed consistent with payments
under Section 6002 of ACA
• Public disclosure of results, post-marketing
commitments
• Exclusion
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COMPLIANCE: FRAUD AND ABUSE
What to look for in the CTA/Budget:
– Payments for PI speaking – “sham” consults
– Bonuses for enrollment of patients
– Payments to patients
– Check CTA and any addendum/amendment language
carefully
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On The Horizon: FDA Proposed Regulations
and Draft Guidance
3/11/2011: FDA has issued a revised Compliance Program Guidance Manual for inspections
of Sponsors, Contract Research Organizations and Monitors,
http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133777.htm.
1/7/2011: Guidance - Electronic Source Documentation in Clinical Investigations. Provides
guidance to sponsors, CROs, data management centers, and clinical investigators on
capturing, using, and archiving electronic data in FDA-regulated clinical investigations.
Comments are due April 7, 2011
2/19/2010: Proposed rule - Reporting Information Regarding Falsification of Data. The
proposed rule will require sponsors to report information indicating that any person has,
or may have, engaged in the falsification of data involving studies including, but not
limited to, clinical investigations, nonclinical laboratory studies, and clinical studies in
animals. Comments are due May 20, 2010.
1/13/2010: Guidance - IRB Continuing Review After Clinical Investigation Approval.
Guidance intended to assist IRBs in carrying out their continuing review responsibility
under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the
criteria, process, and frequency of continuing review to assure the protection of the rights
and welfare of subjects in clinical investigations. The draft guidance should also help
clinical investigators and sponsors better understand their responsibilities related to
continuing review. Comments are due March 15, 2010.
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Questions
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CONTACT INFORMATION
Christee G. Laster
SMITH MOORE LEATHERWOOD LLP
One Atlantic Plaza, Suite 2300
1180 W. Peachtree Street
Atlanta, GA 30309
(404) 962-1052 Tel
[email protected]
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© 2011 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.