Potential Impact of Healthcare Reform Legislation on

Clinical Trials:
Clinical Research Billing,
MSP, MMSEA, and Other
Issues Meant to
Complicate Our Lives
2011 Corporate Council Meeting
17 February 2011
Honolulu, HI
Samuel M Silver, M.D., Ph.D.
Professor, Department of Internal Medicine
Assistant Dean for Research
University of Michigan Health System
Topic Overview
• Medicare & Clinical Research
• Healthcare Reform & Clinical
• Medicare Secondary Payer Issues
• MMSEA and Clinical Trials
• The increasing complexity of TPAs
and self-funded companies
The Current Landscape:
State Laws
34 States and the District of Columbia
Have Clinical Trials Coverage Laws or
Agreements, Although Specifics Vary
from State to State
The Current Landscape:
Federal Laws
• Presidential Executive Memorandum
for Medicare, 2000
• Medicare, Medicaid and State
Children’s Health Insurance
Program Extension Act (MMSEA),
• Patient Protection and Affordable
Care Act (PPACA), 2010
Executive Memorandum
• President Clinton signed an executive
memorandum on June 7, 2000 directing the
Secretary of Health and Human Services to
“explicitly authorize (Medicare) payment for
routine patient care costs. . .and costs due to
medical complications associated with
participation in clinical trials”.
Source: CMS Transmittal AB-00-89
Overarching Goals of the
Medicare NCD
• Allow Medicare beneficiaries to participate in
research studies
• Encourage research that adds to the
knowledge base regarding Medicare
• Allow Medicare beneficiaries to receive care
that may have a health benefit
Covered Routine Costs
• All items and services that are otherwise
generally available to Medicare beneficiaries,
– Those provided absent a clinical trial (e.g.,
conventional care)
– Those required solely for the provision of the
investigational item or service (e.g., administration
of a non-covered chemotherapeutic agent)
– Those required for clinically appropriate monitoring
of effects of investigational item or service, or
prevention of complications
– Those needed for reasonable and necessary care,
for diagnosis or treatment of complications
What is Not Covered
According to the NCD…
“Routine costs of a clinical trial include all items and services
that are otherwise generally available to Medicare
beneficiaries (i.e., there exists a benefit category, it is not
statutorily excluded, and there is not a national non-coverage
decision) that are provided in either the experimental or the
control arms of a clinical trial except:
• The investigational item or service, itself unless otherwise
covered outside of the clinical trial;
• Items and services provided solely to satisfy data
collection and analysis needs and that are not used in the
direct clinical management of the patient (e.g., monthly
CT scans for a condition usually requiring only a single
scan); and
• Items and services customarily provided by the research
sponsors free of charge for any enrollee in the trial.”
Source: CMS. NCD for Routine Costs in Clinical Trials (310.1).
Patient Protection and
Affordable Care Act (PPACA)
Clinical Trials Provision (H.R. 3590,
Sec. 2709)
Signed into law in 2010
Will be effective in 2014
Regulations Pending
Court Challenges
Clinical Trials Coverage
• Coverage required for routine
costs of clinical trials
• Does not require insurer to cover
experimental product or data
collection required solely for the
• Does not preempt state law if
more protective
PPACA is Not a Panacea for
Clinical Trials Coverage
• The PPACA legislation does not include the
– Items and services required for the provision of the
investigational item (e.g., administration of the noncovered chemotherapy drug);
– 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 and treatment of complications arising
from the provision of an investigational item or
PPACA is Not a Panacea for
Clinical Trials Coverage
• “Grandfathered plans”
– Clinical Trial coverage provisions
will not affect employer-based
insurance health plans currently in
effect as of March 23, 2010.
Patient Protection and Affordable Care Act
and Grandfathering (Not just the huge multistate companies):
The University of Michigan believes the
University of Michigan Group Health Plan is a
“grandfathered health plan” under the Patient
Protection and Affordable Care Act (the
Affordable Care Act). As permitted by the
Affordable Care Act, a grandfathered health plan
can preserve certain basic health coverage that
was already in effect when that law was
enacted. Being a grandfathered health plan
means that your plan may not include certain
consumer protections of the Affordable Care Act
that apply to other plans…
What is the Medicare as
Secondary Payer (MSP) rule?
1. Clinical
3. Who Pays
CMS MSP Position
• CMS’s current position is that if a
private sponsor of a clinical trial
agrees to cover any costs of
subject injuries that were denied
by third party payers then the
sponsor has made a commitment
to be the primary payer. MSP laws
are clear that Medicare is always
the secondary payer. Medicaid
laws confirm that Medicaid is
always the payer of last resort.
Contract Language with
MSP Issues
• ". . .Wonder Biotech will pay
reasonable and appropriate
medical and hospital expenses for
the treatment of adverse events,
where the claim is denied by the
study subject's insurance, which
occur to Study subjects as direct
result of the proper administration
of Study drug, or proper
performance of research
procedures specifically required by
the Protocol . . . ."
MSP and Routine Care
Recently CMS has extended their MSP
guidance beyond the costs of research
related injuries to the topic of routine
care. CMS states that if the research
sponsor agrees to pay routine care
costs when there is no expectation of
payment from any other source and
without regard to the beneficiary’s
ability to pay, then Medicare cannot
pay and the beneficiary cannot be
charged for the services. CMS views
this scenario as one where there is no
legal obligation for the patient to pay
and therefore Medicare cannot
reimburse for the services.
Subject Injuries in a Trial:
Section 111 of the MMSEA
• The liability carrier, including a
clinical sponsor who is liable for
injuries, is required to report one
time payments and ongoing
liability for Medicare beneficiaries.
Language from An Insurance Plan
from a Self-Funded Company
• The term “Experimental” when used in
reference to a drug, device, treatment
and/or procedure…satisfies..the following:
a drug, device, treatment or procedure
which Reliable Evidence shows is the
subject of an on-going Phase I, II, or III
clinical trial or is under study to determine
its maximum tolerated dose, its toxicity, its
safety, or its efficacy as compared with a
standard means of treatment or

similar documents