Federal Register, Volume 75, Number 219, November 15, 2010, Pages 69571-69850 Page: 69,594
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:
69594 Federal Register/Vol. 75, No. 219/Monday, November 15, 2010/Rules and Regulations
regulations do not appear inconsistent
with the statutory changes.
Response: We wish to remind
manufacturers that they may not rely on
regulatory provisions and language that
have been withdrawn. Until a
subsequent rule is issued and finalized,
manufacturers should rely on section
1927 of the Act, as amended by the
Affordable Care Act, and regulations
(except those regulations or portions
thereof that have been withdrawn).
Base Date AMP Recalculation
Comment: A few commenters noted
that CMS revised the language in the
regulatory text of 447.510(c),
pertaining to a manufacturer's
recalculation of the base date AMP. One
commenter suggested that CMS should
take this opportunity to amend
447.510(c)(1) by removing the notation
"[OFR: Insert publication date of the
final rule]" and specify when these
recalculations will be permitted in light
of the evolving definition of AMP.
Another commenter thought that the
revision implied that manufacturers
could submit revised base date AMPs on
a product-by-product basis. A third
commenter suggested that
manufacturers be allowed a one-time
restatement of AMP in order to have a
more accurate comparison between base
AMP and the current AMP.
Response: As indicated in the
proposed rule, CMS proposed
conforming regulatory amendments to
447.510, 447.512, and 447.518 as
these sections made specific references
to the provisions being proposed for
withdrawal. It would have been
inappropriate to keep these references to
447.504 and 447.514 since they
would no longer exist in the regulatory
text. By changing the references to
section 1927 of the Act, CMS did not
address whether manufacturers could
restate base date AMPs. The reference to
section 1927 of the Act merely replaces
the references to the withdrawn
regulatory text. As to the comment that
CMS take this opportunity to replace the
notation with the date when the
recalculations would be permitted,
while we appreciate the comment,
taking such action would be outside the
scope of the proposed rule.
Lagged Price Concessions
Comment: We received one comment
expressing confusion over whether the
proposed rule, if finalized, would delete
the regulatory language on the AMP
rolling average methodology for lagged
price concessions that currently appears
as 42 CFR 447.510(d)(2). Specifically,
this commenter questioned whether theproposed rule would delete all of
current 42 CFR 447.510(d)(2) and
replace it with a single sentence, or
whether it is just the first sentence being
replaced and the rolling average
provision would remain intact. The
commenter recommended that CMS
retain the current rolling average
provision in the regulations as this
approach has worked well to date and
is consistent with the Affordable Care
Act smoothing process. The commenter
further stated that during the first year
under the new AMP definition,
manufacturers would like confirmation
from CMS that they may choose
whether to blend pre-ACA lagged price
concessions with post-ACA lagged price
concessions.
Response: We appreciate the
commenter's concern about the
methodology previously described in
447.510(d)(2) regarding the calculation
of monthly AMP. We have decided to
revise the first sentence of this
paragraph as stated in the proposed rule
and delete the remaining sentences. We
will address this issue in future
rulemaking.
Regulatory Impact Statement
Comment: We received one comment
regarding CMS' determination that this
is not an economically significant rule.
The commenter expressed concern that
CMS indicated that the proposed rule
will not have a significant impact on a
substantial number of small entities.
The commenter went on to share their
view that withdrawing parts of the
existing regulation will undoubtedly
help maintain the economic viability of
some community retail pharmacies, but
remained concerned regarding CMS'
implementation of the Affordable Care
Act.
Response: This final rule withdraws
regulatory provisions that have been
superseded by the Affordable Care Act.
In light of the new provisions
established by the Affordable Care Act,
we do not expect that this final rule will
have any significant economic effects on
small business entities. Therefore, CMS
continues to believe this is not an
economically significant rule.
Issues Not Addressed in the Proposed
Rule
We received several comments on
issues that were not addressed in the
proposed rule. Many of the comments
were in regards to the implementation
of the Affordable Care Act. A summary
of these comments is provided below.
However, CMS does wish to clarify that
while we appreciate the comments
provided and recognize that the changes
made by the Affordable Care Act are farreaching, the comments that follow are
outside the scope of this proposed rule.
CMS plans on issuing a proposed
regulation addressing the Affordable
Care Act provisions.
Effective Date of Affordable Care Act
Changes to AMP and FULs
Comment: One commenter indicated
that manufacturers will have to
implement changes to AMP calculations
beginning in October 2011 rather than
October 2010.
Response: We wish to remind all
interested parties, as noted in the
"Background" section of this final rule,
that the new statutory definition of AMP
went into effect as of October 1, 2010.
Manufacturers should rely on the
statute, as revised by the Affordable
Care Act, in calculating AMP.
Implementation of New AMP Definition
Comment: We received a number of
comments regarding the changes the
Affordable Care Act makes to the
definition and determination of AMP.
Several commenters expressed concern
about the implementation of the new
Affordable Care Act definition when
CMS has yet to complete the rulemaking
process. These commenters requested
that CMS delay the implementation of
the new requirements until such time as
further guidance is provided. One
commenter encouraged CMS to provide
sub-regulatory guidance prior to the
issuance of regulations, while another
commenter indicated that CMS should
not issue sub-regulatory guidance as it
could result in ongoing revisions to
AMP calculations. This commenter
stated that manufacturers should be
provided the ability to make the
necessary reasonable assumptions for
AMP calculations until official
regulations are published. Some
commenters provided specific
recommendations as to how CMS
should define AMP, while other
commenters encouraged CMS to seek
stakeholder input as to how to interpret
the statute regarding which entities are
to be included and excluded from the
calculation of AMP, as well as the
planned implementation schedule. One
commenter specifically requested that
CMS ensure that PBM rebates be
excluded from AMP. Another
commenter requested that a smoothing
process be implemented for discounts to
minimize the potential fluctuations in
AMP from month to month. One
commenter stated that AMP calculations
should be consistent with both Average
Sales Price (ASP) and Non-Federal
Average Manufacturer Price (Non-
FAMP) for the VA.
Response: While we appreciate thesecomments and suggestions, they raise
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/m1/32/?rotate=90: accessed April 18, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.