Note:
This article was revised on January 7, 2009, to delete the first question and
answer that was previously on page 2. All other information remains the same.
Provider Types Affected
All physicians, providers, and suppliers who submit claims to Medicare
contractors (carriers, Medicare Administrative Contractors (A/B MACs), durable
medical equipment Medicare Administrative Contractors (DME MACs), fiscal
intermediaries (FIs), and regional home health intermediaries (RHHIs)) for
services provided to Medicare beneficiaries in clinical trials.
Provider Action Needed
This Special Edition article provides clarification regarding Medicare
payment of routine costs associated with clinical trials. Be sure your billing
staff is aware of this information.
Background
The Centers for Medicare & Medicaid Services (CMS) reminds providers
that the policies for payment of the routine costs of the clinical trial are
outlined in chapter 16, section 40 of the Medicare Benefit Policy Manual. The
policy in the manual states:
"40 No Legal Obligation to Pay for or Provide Services
Program payment may not be made for items or services which neither the
beneficiary nor any other person or organization has a legal obligation to pay
for or provide. This exclusion applies where items and services are furnished
gratuitously without regard to the beneficiary’s ability to pay and without
expectation of payment from any source, such as free x-rays or immunizations
provided by health organizations. However, Medicare reimbursement is not
precluded merely because a provider, physician, or supplier waives the charge in
the case of a particular patient or group or class of patients, as the waiver of
charges for some patients does not impair the right to charge others, including
Medicare patients. The determinative factor in applying this exclusion is the
reason the particular individual is not charged."
Key Points of SE0822
There are two concerns addressed in this article regarding "Payment for
Routine Costs in a Clinical Trial" and they are addressed in the following
questions and answers:
- Question:
If the research sponsor pays for the routine costs
provided to an indigent non-Medicare patient (the provider has determined
that the patient is indigent due to a valid financial hardship) may Medicare
payment be made for Medicare beneficiaries?
Answer: 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. As noted at
http://www.cms.hhs.gov/AcuteInpatientPPS/downloads/FAQ_Uninsured.pdf,
"nothing in the Centers for Medicare & Medicaid Services’ (CMS’) regulations
or Program Instructions prohibit a hospital from waiving collection of
charges to any patients, Medicare or non-Medicare, including low-income,
uninsured or medically indigent individuals, if it is done as part of the
hospital’s indigency policy. By "indigency policy" we mean a policy
developed and utilized by a hospital to determine patients’ financial
ability to pay for services. By "medically indigent," we mean patients whose
health insurance coverage, if any, does not provide full coverage for all of
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. In addition to CMS’ policy, the Office
of Inspector General (OIG) advises that nothing in OIG rules or regulations
under the Federal anti-kickback statute prohibits hospitals from waiving
collection of charges to uninsured patients of limited means, so long as the
waiver is not linked in any manner to the generation of business payable by
a Federal health care program – a highly unlikely circumstance
Thus, the provider of services should bill the beneficiary for
co-payments and deductible, but may waive that payment for beneficiaries who
have a valid financial hardship.
- Question:
May a research sponsor pay Medicare co-pays for
beneficiaries in a clinical trial.
Answer: If a research
sponsor offers to pay cost-sharing amounts owed by the beneficiary, this
could be a fraud and abuse problem. In addition to CMS’ policy, the Office
of Inspector General (OIG) advises that nothing in OIG rules or regulations
under the Federal anti-kickback statute prohibits hospitals from waiving
collection of charges to uninsured patients of limited means, so long as the
waiver is not linked in any manner to the generation of business payable by
a Federal health care program.
The citations include 42 U.S.C. 1320a-7(a)(i)(6); OIG Special
Advisory Bulletin on Offering Gifts to Beneficiaries (http://oig.hhs.gov/fraud/docs/alertsandbulletins/SABGiftsandInducements.pdf)
and OIG Special Fraud Alert on Routine Waivers of Copayments and
Deductibles (http://oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html).
Additional Information
Chapter 16, Section 40 of the Medicare Benefit Policy Manual is
available at
http://www.cms.hhs.gov/manuals/Downloads/bp102c16.pdf on the CMS website.
If you have any questions, please contact your Medicare contractor at their
toll-free number, which may be found at
http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip
on the CMS website.
Clarification of Medicare Payment for Routine Costs in a Clinical Trial Reference: MLN: SE0822
