Notice of Hearing: Reconsideration of Disapproval Louisiana Medicaid State Plan Amendment (SPA) 12-66-B, 14145-14146 [2015-06226]
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Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
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Leroy A. Richardson,
Chief, Information Collection Review Office,
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Prevention.
[FR Doc. 2015–06160 Filed 3–17–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Notice of Hearing: Reconsideration of
Disapproval Louisiana Medicaid State
Plan Amendment (SPA) 12–66–B
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of hearing:
Reconsideration of disapproval.
AGENCY:
This notice announces an
administrative hearing to be held on
April 30, 2015, at the Department of
Health and Human Services, Centers for
Medicare and Medicaid Services,
Division of Medicaid & Children’s
Health, Dallas Regional Office, 1301
Young Street, Room 730, Dallas, TX
75202, to reconsider CMS’ decision to
disapprove Louisiana’s Medicaid SPA
12–66–B.
Closing Date: Requests to participate
in the hearing as a party must be
received by the presiding officer by
April 2, 2015.
FOR FURTHER INFORMATION CONTACT:
Benjamin R. Cohen, Presiding Officer,
CMS, 2520 Lord Baltimore Drive, Suite
L, Baltimore, Maryland 21244,
Telephone: (410) 786–3169.
SUPPLEMENTARY INFORMATION: This
notice announces an administrative
hearing to reconsider CMS’ decision to
disapprove Louisiana’s Medicaid SPA
12–66B which was submitted to the
Centers for Medicare and Medicaid
Services (CMS) on December 20, 2012
and disapproved on December 11, 2014.
In part, this SPA requested CMS
approval to revise the current pharmacy
reimbursement methodology for
estimated acquisition cost (EAC) which
is currently calculated as average
acquisition cost (AAC) of the drug
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:26 Mar 17, 2015
Jkt 235001
dispensed to a new calculation of AAC
adjusted by a multiplier of 1.1 for
multiple source drugs and 1.01 for
single source drugs. In addition,
propose a reimbursement methodology
of wholesale acquisition cost (WAC)
adjusted by a multiplier of 1.05 for statedefined specialty therapeutic classes of
drugs.
The issues to be considered at the
hearing are:
• Whether the state’s proposed
increased payment methodology under
Louisiana Medicaid SPA 12–66–B
complies with the requirements of
section 1902(a)(30)(A) of the Act which
requires, in part, that states have
methods and procedures to assure that
payment rates are consistent with
efficiency, economy, and quality of care.
• Whether the state demonstrated that
the proposed payment increases are
consistent with the aggregate upper
payment limits set in implementing
regulations at 42 CFR 447.512 which
provide that payments for drugs are to
be based on the lower of: (1) The
ingredient EAC of the drug and a
reasonable dispensing fee; or (2) the
provider’s usual and customary charges
to the general public.
• Whether the proposed calculation
of EAC used in calculating upper
payment limits (based on a multiple of
the AAC) is consistent with the
definition of EAC in 42 CFR 447.502,
which defines EAC as ‘‘the agency’s best
estimate of the price generally and
currently paid by providers for a drug
marketed or sold by a particular
manufacturer or labeler in the package
size of drug most frequently purchased
by providers.’’
Section 1116 of the Act and federal
regulations at 42 CFR part 430, establish
Department procedures that provide an
administrative hearing for
reconsideration of a disapproval of a
state plan or plan amendment. CMS is
required to publish a copy of the notice
to a state Medicaid agency that informs
the agency of the time and place of the
hearing, and the issues to be considered.
If we subsequently notify the agency of
additional issues that will be considered
at the hearing, we will also publish that
notice.
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5/60
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Any individual or group that wants to
participate in the hearing as a party
must petition the presiding officer
within 15 days after publication of this
notice, in accordance with the
requirements contained at 42 CFR
430.76(b)(2). Any interested person or
organization that wants to participate as
amicus curiae must petition the
presiding officer before the hearing
begins in accordance with the
requirements contained at 42 CFR
430.76(c). If the hearing is later
rescheduled, the presiding officer will
notify all participants.
The notice to Louisiana announcing
an administrative hearing to reconsider
the disapproval of its SPA reads as
follows:
J. Ruth Kennedy
State Medicaid Director
Louisiana Department of Health and
Hospitals
628 N. 4th Street
P.O. Box 91030
Baton Rouge, LA 70821
Dear Ms. Kennedy:
I am responding to your request for
reconsideration of the decision to disapprove
Louisiana’s Medicaid state plan amendment
(SPA) 12–66B, which was submitted to the
Centers for Medicare and Medicaid Services
(CMS) on December 20, 2012, and
disapproved on December 11, 2014. I am
scheduling a hearing on your request for
reconsideration to be held on April 30, 2015,
at the Department of Health and Human
Services, Centers for Medicare and Medicaid
Services, Division of Medicaid & Children’s
Health, Dallas Regional Office, 1301 Young
Street, Room 730, Dallas, TX 75202.
I am designating Mr. Benjamin R. Cohen as
the presiding officer. If these arrangements
present any problems, please contact Mr.
Cohen at (410) 786–3169. In order to
facilitate any communication that may be
necessary between the parties prior to the
hearing, please notify the presiding officer to
indicate acceptability of the hearing date that
has been scheduled and provide names of the
individuals who will represent the state at
the hearing. If the hearing date is not
acceptable, Mr. Cohen can set another date
mutually agreeable to the parties. The
hearing will be governed by the procedures
prescribed by federal regulations at 42 CFR
part 430.
In part, this SPA would revise the current
pharmacy reimbursement methodology for
estimated acquisition cost (EAC) which is
currently calculated as average acquisition
cost (AAC) of the drug dispensed to a new
E:\FR\FM\18MRN1.SGM
18MRN1
14146
Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
calculation of AAC adjusted by a multiplier
of 1.1 for multiple source drugs and 1.01 for
single source drugs. In addition, this SPA
would apply a reimbursement methodology
of wholesale acquisition cost (WAC) adjusted
by a multiplier of 1.05 for state-defined
specialty therapeutic classes of drugs.
The issues to be considered at the hearing
are:
• Whether the state’s proposed increased
payment methodology under Louisiana
Medicaid SPA 12–66–B complies with the
requirements of section 1902(a)(30)(A) of the
Act which requires, in part, that states have
methods and procedures to assure that
payment rates are consistent with efficiency,
economy, and quality of care.
• Whether the state demonstrated that the
proposed payment increases are consistent
with the aggregate upper payment limits set
in implementing regulations at 42 CFR
447.512 which provide that payments for
drugs are to be based on the lower of: 1) the
ingredient EAC of the drug and a reasonable
dispensing fee; or 2) the provider’s usual and
customary charges to the general public.
• Whether the proposed calculation of
EAC used in calculating upper payment
limits (based on a multiple of the AAC) is
consistent with the definition of EAC in 42
CFR 447.502, which defines EAC as ‘‘the
agency’s best estimate of the price generally
and currently paid by providers for a drug
marketed or sold by a particular
manufacturer or labeler in the package size
of drug most frequently purchased by
providers.’’
In the event that CMS and the state come
to agreement on resolution of the issues
which formed the basis for disapproval, this
SPA may be moved to approval prior to the
scheduled hearing.
Sincerely,
Andrew M. Slavitt
Section 1116 of the Social Security Act (42
U.S.C. 1316; 42 CFR 430.18) (Catalog of
Federal Domestic Assistance program No.
13.714. Medicaid Assistance Program.)
Dated: March 13, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–06226 Filed 3–17–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2015–N–0684]
Identification of Alternative In Vitro
Bioequivalence Pathways Which Can
Reliably Ensure In Vivo Bioequivalence
of Product Performance and Quality of
Non-Systemically Absorbed Drug
Products for Animals; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:00 Mar 17, 2015
Jkt 235001
Notification of public meeting;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public meeting
entitled ‘‘Identification of Alternative In
Vitro Bioequivalence Pathways Which
Can Reliably Ensure In Vivo
Bioequivalence of Product Performance
and Quality of Non-Systemically
Absorbed Drug Products for Animals’’.
The purpose of the public meeting is to
discuss the use of in vitro methods as
a mechanism for assessing the in vivo
product bioequivalence (BE) of nonsystemically absorbed drug products
intended for use in veterinary species.
FDA is seeking additional public
comment to the docket, and is
requesting that any written comments
be submitted by May 18, 2015.
Date and Time: The public meeting
will be held on April 16, 2015, from 9
a.m. to 4 p.m.
Location: The public meeting will be
held at the Center for Veterinary
Medicine (CVM), Food and Drug
Administration, 7519 Standish Pl., 3rd
Floor, Conference Room A, Rockville,
MD 20855. Parking is free.
Contact Person: Aleta Sindelar, CVM,
Food and Drug Administration, 7519
Standish Pl., Rm. 144, Rockville, MD
20855, 240–276–9230, FAX: 240–276–
9241, email: BioequivalencePublic
MeetingRegistration@fda.hhs.gov.
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in requesting
an opportunity to speak during the open
public comment period must register by
April 8, 2015, and must include a brief
summary of comments with their
registration. Those individuals will be
contacted prior to the meeting regarding
their participation. Persons interested in
attending this meeting who are not
requesting an opportunity to speak at
the meeting must register by April 14,
2015. For general questions about the
meeting, for assistance registering for
the meeting, to request an opportunity
to make an oral presentation, or to
request special accommodations due to
a disability, contact Aleta Sindelar (see
Contact Person). Please include your
name, organization, and contact
information. Early registration for the
meeting is encouraged due to limited
time and space.
SUPPLEMENTARY INFORMATION:
I. Background
Given the imprecision and logistic
challenges associated with clinical
endpoint BE studies, FDA is exploring
alternative pathways that can be applied
to help ensure the equivalence of
product performance and quality for
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
those products that are non-systemically
absorbed (locally acting).
The assessment of in vivo BE of nonsystemically absorbed drug products has
been a longstanding challenge facing
drug manufacturers and regulators of
human and animal health products.
Although blood level BE trials remain
the standard for comparing drug
products that are systemically absorbed
and that act at a target site reached via
the blood (systemic circulation), such
studies cannot confirm product in vivo
BE when a drug is either not
systemically absorbed or when it is
associated with therapeutic effects
occurring proximal to the site of
absorption. To date, unless the active
pharmaceutical ingredient met the
criteria for highly soluble, as defined in
CVM Guidance #171 entitled ‘‘Waivers
of In Vivo Demonstration of
Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles,’’ clinical endpoint BE trials
have provided the only option for
generating inter-product comparisons.
FDA is exploring whether an alternative
in vitro BE approach may be considered
when blood level BE studies are either
not feasible or not appropriate, and
when products do not meet the criteria
for applying a Guidance #171-based
biowaiver.
The assumption underlying the
application of the in vitro BE approach
is that equivalence in product
physicochemical attributes and in vitro
product performance translates to
equivalence in product in vivo behavior.
For sponsors with a right of reference to
underlying safety and effectiveness data,
the criteria for similarity of
physicochemical attributes would be
defined on the basis of the underlying
dataset to confirm the comparability of
the original formulation and pre- and
post-approval changes in formulation or
method of product manufacture. In the
case of generic products, a more rigid
approach to sameness would be used in
terms of product composition and
physicochemical characteristics. In both
situations, physicochemical
comparisons would be based upon a
battery of in vitro test procedures,
including a comparison of in vitro
dissolution behavior under a range of
physiologically-relevant conditions.
Examples of the kinds of products
where in vitro bioequivalence concepts
can potentially be applied include some
orally administered products (e.g., Type
A medicated articles), solutions,
emulsions, ointments, creams,
suspensions, transdermal products, and
intra-mammary formulations. Due to
unique issues raised by products
E:\FR\FM\18MRN1.SGM
18MRN1
]]>Agencies
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14145-14146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Notice of Hearing: Reconsideration of Disapproval Louisiana
Medicaid State Plan Amendment (SPA) 12-66-B
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of hearing: Reconsideration of disapproval.
-----------------------------------------------------------------------
SUMMARY: This notice announces an administrative hearing to be held on
April 30, 2015, at the Department of Health and Human Services, Centers
for Medicare and Medicaid Services, Division of Medicaid & Children's
Health, Dallas Regional Office, 1301 Young Street, Room 730, Dallas, TX
75202, to reconsider CMS' decision to disapprove Louisiana's Medicaid
SPA 12-66-B.
Closing Date: Requests to participate in the hearing as a party
must be received by the presiding officer by April 2, 2015.
FOR FURTHER INFORMATION CONTACT: Benjamin R. Cohen, Presiding Officer,
CMS, 2520 Lord Baltimore Drive, Suite L, Baltimore, Maryland 21244,
Telephone: (410) 786-3169.
SUPPLEMENTARY INFORMATION: This notice announces an administrative
hearing to reconsider CMS' decision to disapprove Louisiana's Medicaid
SPA 12-66B which was submitted to the Centers for Medicare and Medicaid
Services (CMS) on December 20, 2012 and disapproved on December 11,
2014. In part, this SPA requested CMS approval to revise the current
pharmacy reimbursement methodology for estimated acquisition cost (EAC)
which is currently calculated as average acquisition cost (AAC) of the
drug dispensed to a new calculation of AAC adjusted by a multiplier of
1.1 for multiple source drugs and 1.01 for single source drugs. In
addition, propose a reimbursement methodology of wholesale acquisition
cost (WAC) adjusted by a multiplier of 1.05 for state-defined specialty
therapeutic classes of drugs.
The issues to be considered at the hearing are:
Whether the state's proposed increased payment methodology
under Louisiana Medicaid SPA 12-66-B complies with the requirements of
section 1902(a)(30)(A) of the Act which requires, in part, that states
have methods and procedures to assure that payment rates are consistent
with efficiency, economy, and quality of care.
Whether the state demonstrated that the proposed payment
increases are consistent with the aggregate upper payment limits set in
implementing regulations at 42 CFR 447.512 which provide that payments
for drugs are to be based on the lower of: (1) The ingredient EAC of
the drug and a reasonable dispensing fee; or (2) the provider's usual
and customary charges to the general public.
Whether the proposed calculation of EAC used in
calculating upper payment limits (based on a multiple of the AAC) is
consistent with the definition of EAC in 42 CFR 447.502, which defines
EAC as ``the agency's best estimate of the price generally and
currently paid by providers for a drug marketed or sold by a particular
manufacturer or labeler in the package size of drug most frequently
purchased by providers.''
Section 1116 of the Act and federal regulations at 42 CFR part 430,
establish Department procedures that provide an administrative hearing
for reconsideration of a disapproval of a state plan or plan amendment.
CMS is required to publish a copy of the notice to a state Medicaid
agency that informs the agency of the time and place of the hearing,
and the issues to be considered. If we subsequently notify the agency
of additional issues that will be considered at the hearing, we will
also publish that notice.
Any individual or group that wants to participate in the hearing as
a party must petition the presiding officer within 15 days after
publication of this notice, in accordance with the requirements
contained at 42 CFR 430.76(b)(2). Any interested person or organization
that wants to participate as amicus curiae must petition the presiding
officer before the hearing begins in accordance with the requirements
contained at 42 CFR 430.76(c). If the hearing is later rescheduled, the
presiding officer will notify all participants.
The notice to Louisiana announcing an administrative hearing to
reconsider the disapproval of its SPA reads as follows:
J. Ruth Kennedy
State Medicaid Director
Louisiana Department of Health and Hospitals
628 N. 4th Street
P.O. Box 91030
Baton Rouge, LA 70821
Dear Ms. Kennedy:
I am responding to your request for reconsideration of the
decision to disapprove Louisiana's Medicaid state plan amendment
(SPA) 12-66B, which was submitted to the Centers for Medicare and
Medicaid Services (CMS) on December 20, 2012, and disapproved on
December 11, 2014. I am scheduling a hearing on your request for
reconsideration to be held on April 30, 2015, at the Department of
Health and Human Services, Centers for Medicare and Medicaid
Services, Division of Medicaid & Children's Health, Dallas Regional
Office, 1301 Young Street, Room 730, Dallas, TX 75202.
I am designating Mr. Benjamin R. Cohen as the presiding officer.
If these arrangements present any problems, please contact Mr. Cohen
at (410) 786-3169. In order to facilitate any communication that may
be necessary between the parties prior to the hearing, please notify
the presiding officer to indicate acceptability of the hearing date
that has been scheduled and provide names of the individuals who
will represent the state at the hearing. If the hearing date is not
acceptable, Mr. Cohen can set another date mutually agreeable to the
parties. The hearing will be governed by the procedures prescribed
by federal regulations at 42 CFR part 430.
In part, this SPA would revise the current pharmacy
reimbursement methodology for estimated acquisition cost (EAC) which
is currently calculated as average acquisition cost (AAC) of the
drug dispensed to a new
[[Page 14146]]
calculation of AAC adjusted by a multiplier of 1.1 for multiple
source drugs and 1.01 for single source drugs. In addition, this SPA
would apply a reimbursement methodology of wholesale acquisition
cost (WAC) adjusted by a multiplier of 1.05 for state-defined
specialty therapeutic classes of drugs.
The issues to be considered at the hearing are:
Whether the state's proposed increased payment
methodology under Louisiana Medicaid SPA 12-66-B complies with the
requirements of section 1902(a)(30)(A) of the Act which requires, in
part, that states have methods and procedures to assure that payment
rates are consistent with efficiency, economy, and quality of care.
Whether the state demonstrated that the proposed
payment increases are consistent with the aggregate upper payment
limits set in implementing regulations at 42 CFR 447.512 which
provide that payments for drugs are to be based on the lower of: 1)
the ingredient EAC of the drug and a reasonable dispensing fee; or
2) the provider's usual and customary charges to the general public.
Whether the proposed calculation of EAC used in
calculating upper payment limits (based on a multiple of the AAC) is
consistent with the definition of EAC in 42 CFR 447.502, which
defines EAC as ``the agency's best estimate of the price generally
and currently paid by providers for a drug marketed or sold by a
particular manufacturer or labeler in the package size of drug most
frequently purchased by providers.''
In the event that CMS and the state come to agreement on
resolution of the issues which formed the basis for disapproval,
this SPA may be moved to approval prior to the scheduled hearing.
Sincerely,
Andrew M. Slavitt
Section 1116 of the Social Security Act (42 U.S.C. 1316; 42 CFR
430.18) (Catalog of Federal Domestic Assistance program No. 13.714.
Medicaid Assistance Program.)
Dated: March 13, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-06226 Filed 3-17-15; 8:45 am]
BILLING CODE 4120-01-P
