Federal Register, Volume 75, Number 226, November 24, 2010, Pages 71519-72652 Page: 71,972
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71972 Federal Register/Vol. 75, No. 226/Wednesday, November 24, 2010/Rules and Regulations
rule were generally supportive of the
ASP methodology for payment for
therapeutic radiopharmaceuticals in the
HOPD, and we are finalizing an ASP
payment methodology for separately
payable therapeutic
radiopharmaceuticals for CY 2011, as
discussed in section V.B.3.c. of this final
rule with comment period.
We are finalizing our CY 2011
proposals, without modification, to
provide payment for new therapeutic
radiopharmaceuticals with HCPCS
codes but without pass-through status, if
ASP information is not available, based
on WAC. If WAC information is also
unavailable, we will make payment for
new therapeutic radiopharmaceuticals
at 95 percent of the product's most
recent AWP. In addition, we are
assigning status indicator "K" to HCPCS
codes for new therapeutic
radiopharmaceuticals in CY 2010 that
do not have pass-through status.
Consistent with other ASP-based
payments, for CY 2011, we proposed to
announce any changes to the payment
amounts for new drugs and biologicals
in the CY 2011 OPPS/ASC final rule
with comment period and also on a
quarterly basis on the CMS Web site
during CY 2011 if later quarter ASP
submissions (or more recent WACs or
AWPs) indicate that changes to the
payment rates for these drugs and
biologicals are necessary. The payment
rates for new therapeutic
radiopharmaceuticals will also be
changed accordingly, based on later
quarter ASP submissions. We note that
the new CY 2011 HCPCS codes for
drugs, biologicals, and therapeutic
radiopharmaceuticals were not available
at the time of development of the
proposed rule. However, they are
included in Addendum B to this CY
2011 OPPS/ASC final rule with
comment period. They are assigned
comment indicator "NI" in Addendum B
to reflect that their interim final OPPS
treatment is open to public comment on
this CY 2011 OPPS/ASC final rule with
comment period.
We did not receive any public
comments on our proposal to announce,
via the CMS Web site, any changes to
the OPPS payment amounts for new
drugs and biologicals on a quarterly
basis. Therefore, we are finalizing ourproposal and will update payment rates
for new drugs, biologicals, and
therapeutic radiopharmaceuticals, as
necessary, in association with our
quarterly update process and provide
this information on the CMS Web site.
There are several nonpass-through
drugs and biologicals that were payable
in CY 2009 and/or CY 2010, for which
we did not have CY 2009 hospital
claims data available for the proposed
rule and for which there are no other
HCPCS codes that describe different
doses of the same drug. These drugs and
biologicals do have pricing information
available for the ASP methodology. In
the CY 2011 OPPS/ASC proposed rule
(75 FR46281), we noted that there are
currently no therapeutic
radiopharmaceuticals in this category.
In order to determine the packaging
status of these products for CY 2011, we
calculated an estimate of the per day
cost of each of these items by
multiplying the payment rate for each
product based on ASP+6 percent,
similar to other nonpass-through drugs
and biologicals paid separately under
the OPPS, by an estimated average
number of units of each product that
would typically be furnished to a
patient during one administration in the
hospital outpatient setting. We proposed
to package items for which we estimated
the per administration cost to be less
than or equal to $70, which was the
general packaging threshold that we
proposed for drugs, nonimplantable
biologicals, and therapeutic
radiopharmaceuticals in CY 2011. We
proposed to pay separately for items
with an estimated per day cost greater
than $70 (with the exception of
diagnostic radiopharmaceuticals,
contrast agents, and implantable
biologicals, which we proposed to
continue to package regardless of cost
(as discussed in more detail in section
V.B.2.d. of this final rule with comment
period)) in CY 2011. We proposed that
the CY 2011 payment for separately
payable items without CY 2009 claims
data would be ASP+6 percent, similar to
payment for other separately payable
nonpass-through drugs and biologicals
under the OPPS. In accordance with the
ASP methodology used in the
physician's office setting, in the absenceof ASP data, we proposed to use the
WAC for the product to establish the
initial payment rate. However, we noted
that if the WAC is also unavailable, we
would make payment at 95 percent of
the most recent AWP available.
We did not receive any public
comments on our proposal to use
estimated per day costs for these drugs
and biologicals or on the resulting
packaging status of these drugs and
biologicals. However, upon receiving
updated CY 2009 claims data for HCPCS
codes J1835 (Injection, itraconazole, 50
mg), J2724 (Injection, protein c
concentrate, intravenous, human 10 iu)
and CPT code 90725 (Cholera vaccine
for injectable use), for this final rule
with comment period, we determined
that we no longer needed to calculate an
estimated average number of units for
these two items. Therefore, for CY 2011,
we calculated the packaging status for
HCPCS codes J1835 and J2724 using our
standard methodology as described
above. These codes and their packaging
status are discussed further in section
V.B.2.b. of this final rule with comment
period. We discuss the CY 2011 final
status indicator for 90725 below.
Therefore, we are finalizing our CY 2011
proposal, with modification, to use the
estimated number of units per day
included in Table 35 below, excluding
the estimated number of units for
HCPCS codes J1835, J2724 and CPT
code 90725, to determine estimated per
day costs for the corresponding drugs
and biologicals for CY 2011. Further, we
are finalizing our proposal to package
those drugs with an estimated per day
cost less than or equal to $70 and to
provide separate payment for those
drugs and biologicals (other than
diagnostic radiopharmaceuticals,
contrast agents and implantable
biologicals) with estimated per day costs
over $70 for CY 2011. For those drugs
and biologicals that we determined to be
separately payable in CY 2011, payment
will be made at ASP+5 percent. If ASP
information is not available, payment
will be based on WAC or 95 percent of
the most recently published AWP if
WAC is not available. The final
estimated units per day and status
indicators for these items are displayed
in Table 35 below.TABLE 35-DRUGS AND BIOLOGICALS WITHOUT CY 2009 CLAIMS DATA
Estimated
CY 2011 average num- CY 2011 CY 2011
HCPCS CY 2011 long descriptor ber of units SI APC
code per administra-
tion90681 ........... Rotavirus vaccine, human, attenuated, 2 dose schedule, live, for oral use ....
J0205 ........... Injection, alglucerase, per 10 units ....................................1
420K
K1239
0900
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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/m1/461/: accessed April 25, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.