Federal Register, Volume 75, Number 226, November 24, 2010, Pages 71519-72652 Page: 71,934
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71934 Federal Register/Vol. 75, No. 226/Wednesday, November 24, 2010/Rules and Regulations
4. Provisions for Reducing Transitional
Pass-Through Payments for Diagnostic
Radiopharmaceuticals and Contrast
Agents to Offset Costs Packaged into
APC Groups
a. Background
Prior to CY 2008, diagnostic
radiopharmaceuticals and contrast
agents were paid separately under the
OPPS if their mean per day costs were
greater than the applicable year's drug
packaging threshold. In CY 2008 (72 FR
66768), we began a policy of packaging
payment for all nonpass-through
diagnostic radiopharmaceuticals and
contrast agents as ancillary and
supportive items and services into their
associated nuclear medicine procedures.
Therefore, beginning in CY 2008,
nonpass-through diagnostic
radiopharmaceuticals and contrast
agents were not subject to the annual
OPPS drug packaging threshold to
determine their packaged or separately
payable payment status, and instead all
nonpass-through diagnostic
radiopharmaceuticals and contrast
agents were packaged as a matter of
policy. In the CY 2011 OPPS/ASC
proposed rule (75 FR 46261), for CY
2011, we proposed to continue to
package payment for all nonpass-
through diagnostic
radiopharmaceuticals and contrast
agents, as discussed in section V.B.2.d.
of the proposed rule and this final rule
with comment period.
b. Payment Offset Policy for Diagnostic
Radiopharmaceuticals
As previously noted,
radiopharmaceuticals are considered to
be drugs for OPPS pass-through
payment purposes. As described above,
section 1833(t)(6)(D)(i) of the Act
specifies that the transitional pass-
through payment amount for pass-
through drugs and biologicals is the
difference between the amount paid
under section 1842(o) of the Act (or the
Part B drug CAP rate) and the otherwise
applicable OPD fee schedule amount.
There is currently one
radiopharmaceutical with pass-through
status under the OPPS, HCPCS code
A9582 (lobenguane, 1-123, diagnostic,
per study dose, up to 10 millicuries).
HCPCS code A9582 was granted pass-
through status beginning April 1, 2009
and will continue on pass-through
status in CY 2011. We currently apply
the established radiopharmaceutical
payment offset policy to pass-through
payment for this product. As described
earlier in section V.A.3. of this final rule
with comment period, new pass-through
diagnostic radiopharmaceuticals will bepaid at ASP+6 percent, while those
without ASP information will be paid at
WAC+6 percent or, if WAC is not
available, payment will be based on 95
percent of the product's most recently
published AWP.
As a payment offset is necessary in
order to provide an appropriate
transitional pass-through payment, we
deduct from the payment for pass-
through radiopharmaceuticals an
amount that reflects the portion of the
APC payment associated with
predecessor radiopharmaceuticals in
order to ensure no duplicate
radiopharmaceutical payment is made.
In CY 2009, we established a policy to
estimate the portion of each APC
payment rate that could reasonably be
attributed to the cost of predecessor
diagnostic radiopharmaceuticals when
considering a new diagnostic
radiopharmaceutical for pass-through
payment (73 FR 68638 through 68641).
Specifically, we utilize the "policy-
packaged" drug offset fraction for APCs
containing nuclear medicine
procedures, calculated as 1 minus (the
cost from single procedure claims in the
APC after removing the cost for "policy-
packaged" drugs divided by the cost
from single procedure claims in the
APC). In the CY 2010 OPPS/ASC final
rule with comment period (74 FR 60480
through 60484), we finalized a policy to
redefine "policy-packaged" drugs as
only nonpass-through diagnostic
radiopharmaceuticals and contrast
agents, as a result of the policy
discussed in sections V.A.4. and
V.B.2.d. of the CY 2010 OPPS/ASC final
rule with comment period (74 FR 60471
through 60477 and 60495 through
60499, respectively) that treats nonpass-
through implantable biologicals that are
surgically inserted or implanted
(through a surgical incision or a natural
orifice) and implantable biologicals that
are surgically inserted or implanted
(through a surgical incision or a natural
orifice) with newly approved pass-
through status beginning in CY 2010 or
later as devices, rather than drugs. To
determine the actual APC offset amount
for pass-through diagnostic
radiopharmaceuticals that takes into
consideration the otherwise applicable
OPPS payment amount, we multiply the
"policy-packaged" drug offset fraction
by the APC payment amount for the
nuclear medicine procedure with which
the pass-through diagnostic
radiopharmaceutical is used and,
accordingly, reduce the separate OPPS
payment for the pass-through diagnostic
radiopharmaceutical by this amount.
The I/OCE processes claims for
nuclear medicine procedures only when
they are performed with a radiolabeledproduct. Therefore, the radiolabeled
product edits in the I/OCE require a
hospital to report a diagnostic
radiopharmaceutical with a nuclear
medicine scan in order to receive
payment for the nuclear medicine scan.
We have received questions from
hospitals on how to bill for a nuclear
medicine scan when they receive a
diagnostic radiopharmaceutical free of
charge or with full credit. Currently, if
a hospital receives a diagnostic
radiopharmaceutical free of charge or
with full credit and uses it to provide a
nuclear medicine scan, the hospital
could choose not to bill for both the
nuclear medicine scan and the
diagnostic radiopharmaceutical in order
to bypass the radiolabeled product edits,
but the hospital clearly would not
receive OPPS payment for the scan or
the diagnostic radiopharmaceutical. The
hospital also could report the diagnostic
radiopharmaceutical with the nuclear
medicine scan and receive an APC
payment that includes payment for the
diagnostic radiopharmaceutical, but this
would lead to inaccurate billing and
incorrect payment. The OPPS should
not pay for a free item. We believe
neither of the above alternatives is
satisfactory.
In order to ensure that the OPPS is
making appropriate and equitable
payments under such circumstances
and that a hospital can comply with the
required radiolabeled product edits, in
the CY 2011 OPPS/ASC proposed rule
(75 FR 46261 through 46262), we
proposed for CY 2011 to instruct
hospitals to report the "FB" modifier on
the line with the procedure code for the
nuclear medicine scan in the APCs
listed in Table 22 of the proposed rule
in which the no cost/full credit
diagnostic radiopharmaceutical is used.
Modifier "FB" is defined as an "Item
Provided Without Cost to Provider,
Supplier or Practitioner, or Credit
Received for Replacement Device
(Examples, but not Limited to: Covered
Under Warranty, Replaced Due to
Defect, Free Samples)." Although this
modifier is specific to devices, it
captures the concept of the hospital
receiving a key component of the
service without cost. In cases in which
the diagnostic radiopharmaceutical is
furnished without cost or with full
credit, we proposed to instruct the
hospital to report a token charge of less
than $1.01. We refer readers to the CY
2008 OPPS/ASC final rule with
comment period for more background
information on the "FB" modifier
payment adjustment policies (72 FR
66743 through 66749). We proposed
that when a hospital bills with an "FB"modifier with the nuclear medicine
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United States. Office of the Federal Register. Federal Register, Volume 75, Number 226, November 24, 2010, Pages 71519-72652, periodical, November 24, 2010; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc52807/m1/423/: accessed April 19, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.