80 FR 14145 - Notice of Hearing: Reconsideration of Disapproval Louisiana Medicaid State Plan Amendment (SPA) 12-66-B
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 52 (March 18, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 52 (March 18, 2015)
| Page Range | 14145-14146 | |
| FR Document | 2015-06226 |
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)] [Notices] [Pages 14145-14146] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14145
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Pathologist ...................................................... Pathology Report—No standard form ............ 5 1 5/60
Next-of-kin for deceased miner ...................... 2.6 .................................................................. 5 1 15/60
Leroy A. Richardson, dispensed to a new calculation of AAC Any individual or group that wants to
Chief, Information Collection Review Office, adjusted by a multiplier of 1.1 for participate in the hearing as a party
Office of Scientific Integrity, Office of the multiple source drugs and 1.01 for must petition the presiding officer
Associate Director for Science, Office of the single source drugs. In addition, within 15 days after publication of this
Director, Centers for Disease Control and propose a reimbursement methodology notice, in accordance with the
Prevention. of wholesale acquisition cost (WAC) requirements contained at 42 CFR
[FR Doc. 2015–06160 Filed 3–17–15; 8:45 am] adjusted by a multiplier of 1.05 for state- 430.76(b)(2). Any interested person or
BILLING CODE 4163–18–P defined specialty therapeutic classes of organization that wants to participate as
drugs. amicus curiae must petition the
The issues to be considered at the presiding officer before the hearing
DEPARTMENT OF HEALTH AND begins in accordance with the
hearing are:
HUMAN SERVICES requirements contained at 42 CFR
• Whether the state’s proposed
Centers for Medicare & Medicaid increased payment methodology under 430.76(c). If the hearing is later
Services Louisiana Medicaid SPA 12–66–B rescheduled, the presiding officer will
complies with the requirements of notify all participants.
Notice of Hearing: Reconsideration of section 1902(a)(30)(A) of the Act which The notice to Louisiana announcing
Disapproval Louisiana Medicaid State requires, in part, that states have an administrative hearing to reconsider
Plan Amendment (SPA) 12–66–B methods and procedures to assure that the disapproval of its SPA reads as
payment rates are consistent with follows:
AGENCY: Centers for Medicare & J. Ruth Kennedy
Medicaid Services (CMS), HHS. efficiency, economy, and quality of care.
State Medicaid Director
ACTION: Notice of hearing:
• Whether the state demonstrated that Louisiana Department of Health and
Reconsideration of disapproval. the proposed payment increases are Hospitals
consistent with the aggregate upper 628 N. 4th Street
SUMMARY: This notice announces an payment limits set in implementing P.O. Box 91030
administrative hearing to be held on regulations at 42 CFR 447.512 which Baton Rouge, LA 70821
April 30, 2015, at the Department of provide that payments for drugs are to Dear Ms. Kennedy:
Health and Human Services, Centers for be based on the lower of: (1) The I am responding to your request for
Medicare and Medicaid Services, ingredient EAC of the drug and a reconsideration of the decision to disapprove
Division of Medicaid & Children’s reasonable dispensing fee; or (2) the Louisiana’s Medicaid state plan amendment
Health, Dallas Regional Office, 1301 provider’s usual and customary charges (SPA) 12–66B, which was submitted to the
to the general public. Centers for Medicare and Medicaid Services
Young Street, Room 730, Dallas, TX
(CMS) on December 20, 2012, and
75202, to reconsider CMS’ decision to • Whether the proposed calculation disapproved on December 11, 2014. I am
disapprove Louisiana’s Medicaid SPA of EAC used in calculating upper scheduling a hearing on your request for
12–66–B. payment limits (based on a multiple of reconsideration to be held on April 30, 2015,
Closing Date: Requests to participate the AAC) is consistent with the at the Department of Health and Human
in the hearing as a party must be definition of EAC in 42 CFR 447.502, Services, Centers for Medicare and Medicaid
received by the presiding officer by which defines EAC as ‘‘the agency’s best Services, Division of Medicaid & Children’s
April 2, 2015. Health, Dallas Regional Office, 1301 Young
estimate of the price generally and
Street, Room 730, Dallas, TX 75202.
FOR FURTHER INFORMATION CONTACT: currently paid by providers for a drug I am designating Mr. Benjamin R. Cohen as
Benjamin R. Cohen, Presiding Officer, marketed or sold by a particular the presiding officer. If these arrangements
CMS, 2520 Lord Baltimore Drive, Suite manufacturer or labeler in the package present any problems, please contact Mr.
L, Baltimore, Maryland 21244, size of drug most frequently purchased Cohen at (410) 786–3169. In order to
Telephone: (410) 786–3169. by providers.’’ facilitate any communication that may be
SUPPLEMENTARY INFORMATION: This Section 1116 of the Act and federal necessary between the parties prior to the
hearing, please notify the presiding officer to
notice announces an administrative regulations at 42 CFR part 430, establish indicate acceptability of the hearing date that
hearing to reconsider CMS’ decision to Department procedures that provide an has been scheduled and provide names of the
disapprove Louisiana’s Medicaid SPA administrative hearing for individuals who will represent the state at
12–66B which was submitted to the reconsideration of a disapproval of a the hearing. If the hearing date is not
Centers for Medicare and Medicaid state plan or plan amendment. CMS is acceptable, Mr. Cohen can set another date
mutually agreeable to the parties. The
mstockstill on DSK4VPTVN1PROD with NOTICES
Services (CMS) on December 20, 2012 required to publish a copy of the notice
and disapproved on December 11, 2014. to a state Medicaid agency that informs hearing will be governed by the procedures
In part, this SPA requested CMS the agency of the time and place of the prescribed by federal regulations at 42 CFR
part 430.
approval to revise the current pharmacy hearing, and the issues to be considered. In part, this SPA would revise the current
reimbursement methodology for If we subsequently notify the agency of pharmacy reimbursement methodology for
estimated acquisition cost (EAC) which additional issues that will be considered estimated acquisition cost (EAC) which is
is currently calculated as average at the hearing, we will also publish that currently calculated as average acquisition
acquisition cost (AAC) of the drug notice. cost (AAC) of the drug dispensed to a new
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![14146 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
calculation of AAC adjusted by a multiplier ACTION: Notification of public meeting; those products that are non-systemically
of 1.1 for multiple source drugs and 1.01 for request for comments. absorbed (locally acting).
single source drugs. In addition, this SPA The assessment of in vivo BE of non-
would apply a reimbursement methodology The Food and Drug Administration systemically absorbed drug products has
of wholesale acquisition cost (WAC) adjusted (FDA) is announcing a public meeting been a longstanding challenge facing
by a multiplier of 1.05 for state-defined entitled ‘‘Identification of Alternative In
specialty therapeutic classes of drugs.
drug manufacturers and regulators of
Vitro Bioequivalence Pathways Which human and animal health products.
The issues to be considered at the hearing Can Reliably Ensure In Vivo
are:
Although blood level BE trials remain
Bioequivalence of Product Performance the standard for comparing drug
• Whether the state’s proposed increased and Quality of Non-Systemically
payment methodology under Louisiana products that are systemically absorbed
Medicaid SPA 12–66–B complies with the
Absorbed Drug Products for Animals’’. and that act at a target site reached via
requirements of section 1902(a)(30)(A) of the The purpose of the public meeting is to the blood (systemic circulation), such
Act which requires, in part, that states have discuss the use of in vitro methods as studies cannot confirm product in vivo
methods and procedures to assure that a mechanism for assessing the in vivo BE when a drug is either not
payment rates are consistent with efficiency, product bioequivalence (BE) of non- systemically absorbed or when it is
economy, and quality of care. systemically absorbed drug products associated with therapeutic effects
• Whether the state demonstrated that the intended for use in veterinary species. occurring proximal to the site of
proposed payment increases are consistent FDA is seeking additional public
with the aggregate upper payment limits set
absorption. To date, unless the active
comment to the docket, and is pharmaceutical ingredient met the
in implementing regulations at 42 CFR
447.512 which provide that payments for
requesting that any written comments criteria for highly soluble, as defined in
drugs are to be based on the lower of: 1) the be submitted by May 18, 2015. CVM Guidance #171 entitled ‘‘Waivers
ingredient EAC of the drug and a reasonable Date and Time: The public meeting of In Vivo Demonstration of
dispensing fee; or 2) the provider’s usual and will be held on April 16, 2015, from 9 Bioequivalence of Animal Drugs in
customary charges to the general public. a.m. to 4 p.m. Soluble Powder Oral Dosage Form
• Whether the proposed calculation of Location: The public meeting will be Products and Type A Medicated
EAC used in calculating upper payment held at the Center for Veterinary Articles,’’ clinical endpoint BE trials
limits (based on a multiple of the AAC) is Medicine (CVM), Food and Drug have provided the only option for
consistent with the definition of EAC in 42 Administration, 7519 Standish Pl., 3rd
CFR 447.502, which defines EAC as ‘‘the
generating inter-product comparisons.
Floor, Conference Room A, Rockville, FDA is exploring whether an alternative
agency’s best estimate of the price generally
MD 20855. Parking is free. in vitro BE approach may be considered
and currently paid by providers for a drug
marketed or sold by a particular
Contact Person: Aleta Sindelar, CVM, when blood level BE studies are either
manufacturer or labeler in the package size Food and Drug Administration, 7519 not feasible or not appropriate, and
of drug most frequently purchased by Standish Pl., Rm. 144, Rockville, MD when products do not meet the criteria
providers.’’ 20855, 240–276–9230, FAX: 240–276– for applying a Guidance #171-based
In the event that CMS and the state come 9241, email: BioequivalencePublic biowaiver.
to agreement on resolution of the issues MeetingRegistration@fda.hhs.gov. The assumption underlying the
which formed the basis for disapproval, this Registration: Registration is free and application of the in vitro BE approach
SPA may be moved to approval prior to the available on a first-come, first-served is that equivalence in product
scheduled hearing. basis. Persons interested in requesting physicochemical attributes and in vitro
Sincerely, an opportunity to speak during the open product performance translates to
Andrew M. Slavitt public comment period must register by equivalence in product in vivo behavior.
Section 1116 of the Social Security Act (42 April 8, 2015, and must include a brief For sponsors with a right of reference to
U.S.C. 1316; 42 CFR 430.18) (Catalog of summary of comments with their underlying safety and effectiveness data,
Federal Domestic Assistance program No. registration. Those individuals will be the criteria for similarity of
13.714. Medicaid Assistance Program.) contacted prior to the meeting regarding physicochemical attributes would be
Dated: March 13, 2015. their participation. Persons interested in defined on the basis of the underlying
Andrew M. Slavitt, attending this meeting who are not dataset to confirm the comparability of
Acting Administrator, Centers for Medicare
requesting an opportunity to speak at the original formulation and pre- and
& Medicaid Services. the meeting must register by April 14, post-approval changes in formulation or
[FR Doc. 2015–06226 Filed 3–17–15; 8:45 am]
2015. For general questions about the method of product manufacture. In the
meeting, for assistance registering for case of generic products, a more rigid
BILLING CODE 4120–01–P
the meeting, to request an opportunity approach to sameness would be used in
to make an oral presentation, or to terms of product composition and
DEPARTMENT OF HEALTH AND request special accommodations due to physicochemical characteristics. In both
HUMAN SERVICES a disability, contact Aleta Sindelar (see situations, physicochemical
Contact Person). Please include your comparisons would be based upon a
Food and Drug Administration name, organization, and contact battery of in vitro test procedures,
information. Early registration for the including a comparison of in vitro
[Docket No. FDA–2015–N–0684] meeting is encouraged due to limited dissolution behavior under a range of
time and space. physiologically-relevant conditions.
Identification of Alternative In Vitro SUPPLEMENTARY INFORMATION: Examples of the kinds of products
mstockstill on DSK4VPTVN1PROD with NOTICES
Bioequivalence Pathways Which Can where in vitro bioequivalence concepts
I. Background can potentially be applied include some
Reliably Ensure In Vivo Bioequivalence
of Product Performance and Quality of Given the imprecision and logistic orally administered products (e.g., Type
Non-Systemically Absorbed Drug challenges associated with clinical A medicated articles), solutions,
Products for Animals; Public Meeting endpoint BE studies, FDA is exploring emulsions, ointments, creams,
alternative pathways that can be applied suspensions, transdermal products, and
AGENCY: Food and Drug Administration, to help ensure the equivalence of intra-mammary formulations. Due to
HHS. product performance and quality for unique issues raised by products
VerDate Sep<11>2014 19:00 Mar 17, 2015 Jkt 235001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1](https://thefederalregister.org/doc/80_FR_14197/page/2.svg)
Document Created: 2018-02-21 09:39:27
Document Modified: 2018-02-21 09:39:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of hearing: Reconsideration of disapproval. | |
| Dates | Requests to participate in the hearing as a party must be received by the presiding officer by April 2, 2015. | |
| Contact | Benjamin R. Cohen, Presiding Officer, CMS, 2520 Lord Baltimore Drive, Suite L, Baltimore, Maryland 21244, Telephone: (410) 786-3169. | |
| FR Citation | 80 FR 14145 |
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