Federal Register, Volume 75, Number 219, November 15, 2010, Pages 69571-69850 Page: 69,593
viii, 69849, iii p. ; 28 cm.View a full description of this periodical.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
Federal Register/Vol. 75, No. 219/Monday, November 15, 2010 /Rules and Regulations
impacted by the revisions made to the
Medicaid Drug Rebate Program by the
Affordable Care Act.
Definition of Bona fide Service Fees
Comment: We received several
comments regarding the definition of
bona fide service fees. A few
commenters indicated the need for CMS
to ensure that when it promulgates new
regulations to implement the changes
made by the Affordable Care Act, it
seeks stakeholder input and provides
further clarity on the treatment of bona
fide service fees for the purposes of
AMP reporting. Two commenters
expressed concern that in the proposed
rule, CMS did not propose to withdraw
the definition of bona fide service fee.
These commenters recommended that
CMS also withdraw the definition of
bona fide service fee to be consistent
with the definition of bona fide service
fee enacted by the Affordable Care Act.
Other commenters recommended that
despite the change the Affordable Care
Act makes to the definition of bona fide
service fee, the existing definition
should remain intact and unchanged.
One commenter noted that the language
in the Affordable Care Act presupposes
a background definition of bona fide
service fees that would be applied to the
named fees and any others paid by a
manufacturer. Another commenter
recommended that CMS provide
clarification on how manufacturers
should evaluate the language in the
Affordable Care Act to be consistent
with the historical definition.
Response: We appreciate the
comments pertaining to bona fide
service fees. At this time, we believe it
would be inappropriate to withdraw the
definition of bona fide service fee from
the AMP final rule because the
definition of bona fide service fee that
is in 447.502 "Definitions" was
intended to apply to both AMP and best
price calculations. While the
Determination of AMP ( 447.504) is
being withdrawn, at this time, no
change is being made to the
Determination of Best Price ( 447.505).
Therefore, we see no need to withdraw
the definition of bona fide service fees.
We do note, however, that the definition
of bona fide service fee at 447.502
should not be used in the calculation of
AMP. Issues related to the Affordable
Care Act's treatment of bona fide service
fees will be addressed in future
rulemaking.
Definition of Multiple Source Drug
Comment: We received a few
comments on the definition of "multiple
source drug." One commenter indicatedthat an accurate definition of "multiple
source drug" is critical to the
implementation of the provisions of the
Affordable Care Act. Two commenters
stated that CMS should allow for public
review and comment on a definition for
what constitutes a "multiple source
drug" that is available for purchase by
retail community pharmacies on a
nationwide basis.
Response: CMS continues to believe
that the definition of "multiple source
drug" in 447.502 should be withdrawn
in light of changes to the relevant
statutory language in the Affordable
Care Act. In the absence of Federal
guidance or regulation, manufacturers
should rely on section 1927(k)(7) of the
Act, as amended by the Affordable Care
Act, for the definition of "multiple
source drug."
Withdrawal of Determination of AMP
( 447.504)
Comment: We received one comment
indicating support for the position that
AMP continue to be calculated using the
current regulation (42 CFR
447.504(g)(1)). This commenter
indicated that if CMS were to change
the definition of AMP and therefore
require manufacturers to purchase data
from wholesalers in order to calculate
AMP, it would be a substantial burden
and expense and could result in less
accurate data.
Response: CMS interpreted this
comment to mean the commenter
disagreed with the withdrawal of
447.504 in its entirety since the
commenter specifically mentioned
447.504(g)(1) in support of continuing
to calculate AMP using the current
regulation. We appreciate this comment,
but in light of the changes in relevant
statutory language, CMS continues to
believe that withdrawing 447.504 in
its entirety is the appropriate action at
this time.
Monthly AMP Calculations
Comment: One commenter suggested
that CMS modify the quarterly AMP
calculation requirement under
447.504(i)(2) by eliminating the
requirement that manufacturers report
monthly AMP for single source drugs.
Response: In light of the changes in
relevant statutory language made by the
Affordable Care Act, we continue to
believe it is necessary to withdraw all of
447.504 at this time. In addition, we
are not making further changes to the
monthly AMP reporting requirements in
this final rule.
Quarterly AMP Calculations
Comment: One commenter requested
that CMS confirm the methodology forcalculating quarterly AMPs stating that
the proposed rule would delete the
current provision (42 CFR
447.504(i)(2)) that provides that the
"[q]uarterly AMP is calculated as a
weighted average of the monthly AMPs
in the quarter." This commenter
requested clarification on whether
manufacturers should continue to
calculate quarterly AMPs as a function
of the monthly AMPs or whether a
separate calculated quarterly AMP
would be permitted or required.
Response: CMS recognizes that with
the deletion of 447.504 Determination
of AMP, manufacturers will have
questions regarding the calculation of
AMP, including monthly and quarterly
AMP calculations. Manufacturers
should rely on the statutory language
found at section 1927(k)(1) of the Act,
as amended by the Affordable Care Act,
and regulations (except those
regulations or portions thereof have
been withdrawn).
Customary Prompt Pay Discounts
Comment: We received a few
comments regarding the definition of
"customary prompt pay discounts." One
commenter noted that the removal of
447.504 would remove the definition
of "customary prompt pay discounts"
and would therefore create ambiguity as
to whether a discount is customary. The
commenter suggested that the definition
of "customary prompt pay discounts"
should remain in the regulation.
Another commenter requested that CMS
confirm that when it issues future
regulations, it does not intend to change
the definition of "customary prompt pay
discounts," which the proposed rule
would withdraw.
Response: Given the amendments
made by the Affordable Care Act, we
continue to believe that withdrawing
447.504 in its entirety is the
appropriate action at this time. We do
expect to address this issue in future
rulemaking. Until such time as those
rules are issued and finalized,
manufacturers should operate consistent
with the Medicaid drug rebate statute,
and regulations (except those
regulations or portions thereof that have
been withdrawn).
Reasonable Assumptions
Comment: We received one comment
asking if the proposed regulation was
designed to change the reasonable
assumption option provided to
manufacturers in the AMP final rule.
The commenter went on to request that
CMS confirm that manufacturers'
reasonable assumptions may include
assumptions based on the current AMPregulations to the extent that those
69593
Upcoming Pages
Here’s what’s next.
Search Inside
This issue can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Periodical.
United States. Office of the Federal Register. Federal Register, Volume 75, Number 219, November 15, 2010, Pages 69571-69850, periodical, November 15, 2010; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc52800/m1/31/?rotate=90: accessed April 23, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.