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The what, why and how of Medicare Coverage Analysis – Part I ...continued from page 45
5. It is sponsored by a credible organization/
individual who is capable of executing the
trial successfully.
6. It complies with federal regulations
regarding human subject protections.
7. It is conducted in accordance with appropriate
standards of academic integrity.
This certification process also requires that
the PI enrolls the trial in the Medicare clinical
trials registry. The registry, per CMS, is under
development and the option to qualify a
trial on the basis of the PI’s certification is,
as stated above, not practically available at
this time. Once a trial meets the criteria as
“qualifying” for Medicare coverage and in
order to be reimbursable by Medicare, each of
its items and services must be (1) identified as
a “routine cost” and (2) declared reasonable
and necessary. (The criteria and the review
process for each item and service to determine
if it is a “routine cost” will be covered in detail
by Part 2 of this article.)
The elaborate statutory environment and
intricate coverage issues present clinical trial
sites with complex regulatory requirements
and, potentially, far-reaching consequences for
non-compliance. In 1995, the Rush University
Medical Center settlement with the HHS
Office of Inspector General (OIG) for allegations
of research-related Medicare over-billing
included $1 million in reimbursement and
penalties and a Certification of Compliance
Full Name:
Title:
Organization:
Address:
City/State/Zip:
Telephone:
Fax:
E-mail:
Agreement (CCA.) Furthermore, the OIG
identified “…reporting of financial support
from other sources…” as a risk area in its 2004
Medicare Work Plan and the item remains a
priority in OIG’s annual work plans.
Evaluation of research billing operations is,
therefore, an integral part of any high-level
risk assessment of a clinical trial-participating
health care facility. In this context, an
inadequately performed and/or ineffectively
deployed MCA may represent a substantial
compliance risk. An analysis that does not
clearly identify a therapeutic intent; performs
an ad hoc classification of routine care;
or does not provide adequate support for
routine care classifications by an NCD and/or
LCD, rules, manuals, guidance documents,
compendia, etc could lead to allegations of
False Claims Act violation and subsequent
enforcement and legal action.
By contrast, a properly performed and
implemented MCA demonstrates careful
consideration and provides significant protection
against charges of FCA violation. The
MCA, therefore, has a vital role in a health
care entity’s risk management and compliance
programs as a key compliance control.
The MCA may be conducted by and within
a variety of business units in a health care
enterprise. It should also be performed by an
adequately-trained professional. The MCA
is, additionally, a product of a partnership
between key trial and operations stakeholders:
the PI, research staff, providers, the
Institutional Review Board (IRB), sponsors,
coders, billing staff, Financial, Compliance,
Contracts and Grants offices, and many more.
The correctly-conducted MCA is, therefore,
not only an essential billing compliance
control; it is also a cornerstone of a clinical
trial’s financial analysis and budget process.
In summary, Part I of this article about
Medicare Coverage Analysis, provided
statutory context, illustrated the need for and
benefits of the MCA process, and discussed
potential consequences for non-compliance.
It highlighted certain processes and a variety
of documents that jointly define coverage,
presented criteria for Medicare coverage,
and introduced key participants of the MCA
process. Part 2 of this article will focus on
the methodology and tools for conducting a
Medicare Coverage Analysis. n
1 42 U.S.C. §1395
2 P.L. 74-271
3 42 U.S.C. §1395y (a)(1)(A)
4 31 U.S.C. §3729-3733
5 P.L. 104-191
6 P.L. 105-33
7 P.L. 105-33, Section 4108 (b)(2)(D)
8 Pub 100-03, Medicare National Coverage Determinations for Routine
Costs in Clinical Trials (310.1)
9 Benefits Improvement and Protection Act (BIPA)
10 68 Fed Reg. 55634
11 63 Fed Reg. 68780
12 Social Security Act, Section 1861(t)(2)(B)(ii)(I)
13 http://www.cms.hhs.gov/mcd/overview.asp accessed June 23, 2008
14 FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization
of Investigational Devices September 15, 1995 (D95-2)
15 21 CFR 860
16 Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (MMA), section 731(b)
17 http://www.cms.hhs.gov/center/coverage.asp accessed June 23, 2008
18 Pub 100-03, Medicare National Coverage Determinations for Routine
Costs in Clinical Trials (310.1)
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