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The what, why and how of Medicare Coverage Analysis – Part I ...continued from page 43
Review Policies (LMRPs), now named Local
Coverage Determination or LCDs). 9 LCDs
are crafted by Medicare contractors – Carriers,
Fiscal Intermediaries (FIs), and Medicare
Administrative Contractors (MACs) – to
address national or local policy gaps that
may result in billing for services or items that
could be considered neither reasonable nor
necessary. LCDs make up the majority of
current coverage determinations; they contain
decisions that supplement the CTPs; LCDs
may differ between contractors. A National
Coverage Analysis (NCA) may be initiated
to set rules that settle inconsistencies or vast
differences between LCDs.
A National Coverage Analysis (NCA), a
formal evidence-based evaluation process,
may also be triggered by industry, Carriers,
beneficiaries, and others. 10 The NCA considers
input from the Medicare & Coverage Advisory
Committee (MCAC), experts, and the
public in formulating rules about coverage. 11
Guidance about coverage is also available
from certain compendia. 12 The American
Medical Association Drug Evaluations and the
American Hospital Formulary Service (AHFS)
Drug Information, for example, are acceptable
as authoritative sources for the determination
of a “medically-accepted indication” for a drug.
The Medicare Coverage Database (MCD) 13
contains all NCDs, LCDs, local policy articles,
NCA reports, Coding Analyses for Labs
(CALs), MCAC proceedings, and additional
coverage guidance documents, which are
available to the MCA professional as a resource
in determining Medicare coverage for an item
or service.
Of special interest is Medicare coverage for
clinical trials involving medical devices.
Although the CTP allows reimbursement
for items and services that are “…reasonable
and necessary…” and are for “…diagnosis or
treatment…” these provisions were historically
interpreted as requiring that the service
or item (i.e., the device) is also safe and effective,
medically necessary and appropriate, and
not experimental (where experimental was
interchangeably used with investigational).
In September 1995, the regulator [the Food
and Drug Administration (FDA)], and the
purchaser [CMS] thus entered an interagency
agreement 14 that:
n Grouped medical devices, for coverage determination
purposes, into two categories
(A and B), and
n Extended Medicare coverage to select
Category A devices and, to a larger extent,
to certain Category B devices.
Category A devices are defined as “Innovative
devices believed to be in class III medical
device for which absolute risk of the device
type has not been established.” Category
B devices are defined as “Nonexperimental
and/or investigational devices believed to be
in classes I or II medical device 15 or devices
believed to be in class III where the incremental
risk is the primary risk in question or it is
known that the device type can be safe and
effective.... 16
Medicare coverage determinations are embedded
in a complex and, at-times, inconsistent
array of guidelines, manuals, Prospective
Payment Systems (PPS), and publications
– many of which are available at CMS’ website.
17 Criteria for coverage, on the other hand,
are derived from the regulations. 18 They state
that a clinical trial considered for potential
Medicare coverage for routine costs must:
1. Have the purpose of evaluating an item or
service that belongs to a Medicare benefit
category,
2. Have a therapeutic intent, and
3. Enroll patients with a diagnosed disease.
However, Medicare coverage is extended only
to routine costs in a trial that is:
1. Deemed as automatically qualified; or
2. Qualified by virtue of a certification by
the Principal Investigator (PI) that it
meets qualification criteria; or
3. Its routine costs are allowed under Coverage
with Evidence Development (CED).
Although option 2 above (certification by the
PI) is allowed per the regulations, no steps
were taken to date to implement it and, from
a practical standpoint, the option is currently
unavailable. A clinical trial is automatically
deemed as qualified if it is:
1. Funded by the National Institute of
Health (NIH), the Center for Disease
Control and Prevention (CDC), the
Agency for Healthcare Research and
Quality (AHRQ), CMS, the Department
of Defense (DOD), or the US Department
of Veterans Affairs (VA); or
2. Supported by a center or cooperative
group which is funded by the NIH,
CDC, AHRQ, CMS, DOD or VA; or
3. Conducted under an Investigational New
Drug application (IND) reviewed by the
FDA; or
4. Exempt from having an IND and until qualifying
criteria are developed and the process
for certifying trials by the PIs is in place.
To qualify a trial that is not deemed automatically
qualified, a PI is required to certify
that it meets the following criteria:
1. It tests whether the intervention potentially
improves the participants’ health
outcomes.
2. It is well-supported by scientific and
medical information or intends to clarify
or establish the health outcomes of interventions
already in common clinical use.
3. It does not unjustifiably duplicate an
existing trial.
4. It is properly designed to address the corresponding
hypothesis.
Continued on page 52
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
45
October 2008