[Federal Register: August 3, 2004 (Volume 69, Number 148)]
[Notices]
[Page 46549-46550]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au04-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services
Notice of Hearing: Reconsideration of Disapproval of Vermont
State Plan Amendment (SPA) 03-015a
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of hearing.
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SUMMARY: This notice announces an administrative hearing to be held on
August 25, 2004, at 10 a.m., JFK Federal Building, Room 2325, Boston,
Massachusetts 02203-0003, to reconsider our decision to disapprove
Vermont State Plan Amendment (SPA) 03-015a.
DATES: Requests to participate in the hearing as a party must be
received by the presiding officer by August 18, 2004.
FOR FURTHER INFORMATION CONTACT: Kathleen Scully-Hayes, Presiding
Officer, CMS, Lord Baltimore Drive, Mail Stop LB-23-20, Baltimore,
Maryland 21244. Telephone: (410) 786-2055.
SUPPLEMENTARY INFORMATION: This notice announces an administrative
hearing to reconsider our decision to disapprove Vermont State Plan
Amendment (SPA) 03-015a, which Vermont submitted to the Centers for
Medicare & Medicaid Services (CMS) on September 30, 2003. In SPA 03-
15a, Vermont proposes to establish State-only Medicaid supplemental
rebate agreements under which pharmaceutical manufacturers would pay
supplemental rebates to the State based on Medicaid utilization in the
State, for the period from October 1, 2002, through June 30, 2003. The
level of the supplemental rebates would also be based on a ``multi-
state pooling'' arrangement to take into account aggregate utilization
levels among several participating states. The Centers for Medicare &
Medicaid Services (CMS) reviewed this proposal and determined it was
unable to approve SPA 03-015a for the reasons set forth below.
At issue is whether the requested effective date of October 1,
2002, is consistent with statutory and regulatory requirements. States
receiving Federal Medicaid funding must have approved state plans that
describe the nature and scope of the state Medicaid program and must
fulfill the requirements for approval set forth in section 1902(a) of
the Social Security Act (the Act) and pertinent regulations as set
forth in 42 CFR 430.15(a). Federal regulations at 42 CFR 430.20(b)
provide that the rules of 42 CFR 447.256 apply with respect to the
effective date of a plan amendment that changes the state's payment
methods and standards. Federal regulations at 42 CFR 447.256 provide
that the effective date of such amendments may not be earlier than the
first day of the calendar quarter in which an approvable plan is
submitted.
CMS concluded that the change proposed by Vermont amounted to a
change in the State's payment methods and standards, and that the
earliest approvable effective date would be the first day of the
calendar quarter in which the SPA was submitted, or July 1, 2003. In a
separate action, CMS approved SPA 03-15b, which authorized State-only
Medicaid supplemental rebate agreements and participation in a multi-
state pooling arrangement effective July 1, 2003.
In addition, section 1902(a)(19) of the Act requires that care and
services under the plan be provided in a manner
[[Page 46550]]
consistent with simplicity of administration and the best interests of
recipients. CMS was concerned that approval of a retroactive effective
date could, in some circumstances, adversely impact beneficiary access
and would be inconsistent with these provisions.
Based on the above, and after consultation with the Secretary of
the Department of Health and Human Services as required under Federal
regulations at 42 CFR 430.15(c)(2), CMS disapproved Vermont SPA 03-
015a.
Section 1116 of the Act and 42 CFR part 430 establish Departmental
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 Vermont announcing an administrative hearing to
reconsider the disapproval of its SPA reads as follows:
Mr. Charles P. Smith, Secretary, Vermont Agency of Human Services
103 South Main Street, Waterbury, VT 05671-0204.
Dear Mr. Smith: I am responding to your request for
reconsideration of the decision to disapprove Vermont State Plan
Amendment (SPA) 03-015a, which Vermont submitted on September 30,
2003. In SPA 03-15a, Vermont proposes to establish State-only
Medicaid supplemental rebate agreements under which pharmaceutical
manufacturers would pay supplemental rebates to the State based on
Medicaid utilization in the State, for the period from October 1,
2002, through June 30, 2003. The level of the supplemental rebates
would also be based on a ``multi-state pooling'' arrangement to take
into account aggregate utilization levels among several
participating states. The Centers for Medicare & Medicaid Services
(CMS) reviewed this proposal and was unable to approve SPA 03-015a
for the reasons set forth below.
At issue is whether the requested effective date of October 1,
2002, is consistent with statutory and regulatory requirements.
States receiving Federal Medicaid funding must have approved state
plans that describe the nature and scope of the state Medicaid
program and must fulfill the requirements for approval as set forth
in section 1902(a) of the Social Security Act (the Act) and
pertinent regulations as set forth in 42 CFR 430.15(a). Federal
regulations at 42 CFR 430.20(b) provide that the rules of 42 CFR
447.256 apply with respect to the effective date of a plan amendment
that changes the state's payment methods and standards. Federal
regulations at 42 CFR 447.256 provide that the effective date of
such amendments may not be earlier than the first day of the
calendar quarter in which an approvable plan is submitted.
CMS concluded that the change proposed by Vermont amounted to a
change in the State's payment methods and standards, and that the
earliest approvable effective date would be the first day of the
calendar quarter in which the SPA was submitted, or July 1, 2003. In
a separate action, CMS approved SPA 03-15b, which authorized State-
only Medicaid supplemental rebate agreements and participation in a
multi-state pooling arrangement effective July 1, 2003.
In addition, section 1902(a)(19) of the Act requires that care
and services under the plan be provided in a manner consistent with
simplicity of administration and the best interests of recipients.
CMS was concerned that approval of a retroactive effective date
could, in some circumstances, adversely impact beneficiary access
and would be inconsistent with these provisions.
Based on the above, and after consultation with the Secretary of
the Department of Health and Human Services as required under
Federal regulations at 42 CFR 430.15(c)(2), CMS disapproved Vermont
SPA 03-015a.
I am scheduling a hearing to be held on August 25, 2004, at
10:00 a.m., JFK Federal Building, Room 2325, Boston, Massachusetts
02203-0003, to reconsider our decision to disapprove Vermont SPA 03-
015a.
If this date is not acceptable, we would be glad to set another
date that is mutually agreeable to the parties. The hearing will be
governed by the procedures prescribed at 42 CFR Part 430.
I am designating Ms. Kathleen Scully-Hayes as the presiding
officer. If these arrangements present any problems, please contact
the presiding officer. In order to facilitate any communication that
may be necessary between the parties 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. The presiding officer may
be reached at (410) 786-2055.
Sincerely,
Mark B. McClellan, M.D., Ph.D.
Section 1116 of the Social Security Act (42 U.S.C. section
1316); 42 CFR Section 430.18.
(Catalog of Federal Domestic Assistance Program No. 13.714, Medicaid
Assistance Program.)
Dated: July 21, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-17578 Filed 8-2-04; 8:45 am]
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