Vaccines
for Children Program (VFC)
For Parents |
|
Federal
Register
NOTE:
The fee table was published in the Federal
Register on October 3, 1994 and remains
unchanged as of Dec. 2003.
|
|
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[MB-84-NC]
RIN 0938-AG77
Medicaid Program; Charges for Vaccine Administration
Under the Vaccines for Children (VFC) Program
AGENCY:
Health Care Financing Administration (HCFA),
HHS.
ACTION: Notice with comment period.
----------------
SUMMARY:
This notice with comment period lists, by State,
the interim regional maximum charges that providers
may impose for the administration of pediatric
vaccines to Federally vaccine-eligible children
under the Pediatric Immunization Distribution
Program, more commonly known as the Vaccines
for Children (VFC) program. This notice also
specifies the methodology that HCFA used to
establish the maximum administration charges.
In
addition, the notice provides States that purchase
vaccines for all children the option to use
these maximum charges or devise their own,
and clarifies that State Medicaid agencies
may establish lower fees than these maximums
if they can provide assurances of access to
immunizations for Medicaid eligible children
to the same extent as the general population.
The
publication of these administration charges
is essential to implementation of the VFC program,
which is mandated by law to become operational
on October 1, 1994. We intend that this list
be used on an interim basis until we issue
a separate Federal Register document that will
finalize these maximum regional charges and
respond to any relevant public comments.
EFFECTIVE
DATE: October 1, 1994.
FOR
FURTHER INFORMATION CONTACT: Marge Sciulli,
(410) 966-0691.
SUPPLEMENTARY
INFORMATION:
I.
Background
The
Omnibus Budget Reconciliation Act of 1993 (OBRA '93), Public Law
103-66, created the Pediatric Vaccine Distribution Program (more
commonly known and hereafter referred to as the Vaccines for Children
(VFC) Program), which takes effect on October 1, 1994. Section 13631
of OBRA '93 added section 1902(a)(62) to the Social Security Act
(the Act) to require that States provide for a program for the purchase
and distribution of pediatric vaccines to program-registered providers
for the immunization of vaccine-eligible children in accordance
with section 1928 of the Act. Section 13631 redesignated the existing
section 1928 as section 1931 and inserted a new section 1928. The
new section 1928 requires each State to establish a VFC Program
(which may be administered by the State department of health) under
which certain specified groups of children are entitled to receive
qualified pediatric immunizations without charge for the cost of
the vaccine.
Federally
purchased vaccines under the VFC Program will
be made available to children who are 18 years
of age or younger and—
o Who are eligible for Medicaid;
o Who are not insured under any form of health
insurance;
o Who are not insured with respect to the vaccine
and who are administered pediatric vaccines
by a federally qualified health center (FQHC)
or in a rural health clinic; or
o Who are Indians, as defined in section 4
of the Indian Health Care Improvement Act.
Under
the VFC program, vaccines must be administered
by program-registered providers. Section 1928(c)
defines a program-registered provider as any
health care provider that—
o Is licensed or authorized to administer pediatric
vaccines under the law of the State in which
the administration occurs without regard to
whether or not the provider is a Medicaid-participating
provider;
o Submits to the State an executed provider
agreement in the form and manner specified
by the Secretary; and
o Has not been found by the Secretary or the
State to have violated a provider agreement
or other requirements that may apply that are
established by the Secretary or the State.
Providers
may participate in the VFC program without
participating in Medicaid if they are qualified
to administer vaccines under applicable State
law. However, such providers will not be reimbursed
by Medicaid for their services in administering
the vaccine.
Under
the VFC Program, a provider may impose a fee
for the administration of a qualified pediatric
vaccine as long as the fee, in the case of
a Federally vaccine-eligible child, does not
exceed the cost of such administration (as
determined by the Secretary based on actual
regional costs for such administration). However,
a provider may not deny administration of a
qualified pediatric vaccine to a vaccine-eligible
child due to the inability of the child's parents
or legal guardian to pay the administration
fee.
II.
Provisions of This Notice With Comment Period
A.
General Statement
This
notice announces interim regional maximum charges.
These represent the maximum amount that a provider
in a State may charge for the administration
of qualified pediatric vaccines to Federally
vaccine-eligible children under the VFC Program.
It also specifies the methodology that HCFA
used to establish these regional maximum charges.
We are interpreting “regional'' as specified
in the statute to be the “State'', as
discussed in section II.B.2. of this notice.
In addition, this notice gives Universal Purchase
States (that is, where the vaccines are purchased
by the State for all children in the State)
the right to develop administration charges
that differ from those established by HCFA,
provided they are reasonable. Therefore, Universal
Purchase States are provided the flexibility
to accept the maximum charges established by
the Secretary or to develop their own maximum
charges. In either case, the statute gives
State Medicaid agencies the option to establish
and apply vaccine administration fees that
are lower than the specified maximum charges
if they provide assurances that Medicaid children
have access to immunizations to the same extent
as the general population. Section 1902(a)(30)(A)
of the Act, as amplified by section 1926, requires
States to pay enough for obstetrical and pediatric
services (which include immunization services)
so that those services are available to the
“Medicaid population'' to the same extent
that are available to the general population
in the geographic area. These assurances must
be submitted to HCFA as part of the appropriate
State plan amendment to impose the fees. This
notice specifies guidelines for States to use
in setting lower administration fees.
The
administration charge cap applies to all VFC
Program-registered providers that administer
the vaccine to a Federally vaccine-eligible
child. It does not apply to children receiving
free vaccines under State purchase programs
or any other arrangement.
In
accordance with the statute, physicians participating
in the VFC Program can charge non-Medicaid
eligible children the maximum administration
charge (if that charge reflects the provider's
cost of administration) regardless of whether
the State has established a lower administration
fee under the Medicaid program. However, there
would be no Federal Medicaid matching funds
available for such administration. Although
the cost of the vaccines for the VFC Program
is funded under Title XIX of the Act, Medicaid
will not pay for the administration of vaccines
provided to children under the VFC Program
who are not eligible for Medicaid. A provider
may only bill Medicaid for the administration
of a vaccine if the child is Medicaid eligible.
Because
the VFC program is mandated by law to become
operational on October 1, 1994, we are announcing
these regional maximum administration charges
and guidelines for documenting access on an
interim basis, subject to comment and revision.
We will issue a final Federal Register document
setting forth the applicable requirements and
responding to public comments on the provisions
of this notice that we receive on a timely
basis.
B.
Methodology Used to Establish Administration
Charges
We
used the following methodology to establish
the regional maximum charges for administration
of qualified pediatric vaccines set forth under
section II.C. of this notice.
1.
Basis for Using Charge Data versus Cost Data
As
noted above, the statute provides that these
maximum charges are to be based in the actual
costs of vaccine administration, as determined
by the Secretary. This provision posed a serious
implementation problem for HCFA because of
the unavailability of usable actual cost data
on a nationwide basis and the urgency of promulgating
maximum fees before the VFC program begins
operation. We searched thoroughly for appropriate
data on the costs of vaccine administration.
We also consulted with several organizations
and with individuals with knowledge and expertise
in issues regarding physician payment, including
the Physician Payment Review Commission (PPRC).
We were informed that there are no data readily
available on physicians' actual costs that
would provide a valid basis for setting these
maximum charges on a nationwide scale. It also
was apparent to us that it would not be possible
to generate such data via field research within
the time available to implement the VFC program
on October 1, 1994. A proper analysis would
require detailed, expensive, and time-consuming
collection and evaluation of data on each element
of both direct and indirect costs, including
equipment, supplies and labor, as well as an
appropriate verification and allocation of
“overhead'' costs.
On
the basis of this information, we concluded
that we should explore setting the maximum
charges based on data regarding actual charges
for the administration of vaccines in physicians'
offices. This, too, posed a problem. We consulted
with insurance companies, physicians' groups,
trade associations, the PPRC, and other knowledgeable
experts. Again, we concluded that accurate,
consistent data on charges were not readily
available. There are a number of concerns about
the data that are available, including inconsistencies
in the coding of procedures and the fact that
most payers do not differentiate, or pay separately
for, the cost of the vaccine and its administration.
In light of these problems, we were unable
to construct a reliable data base by integrating
data from existing information sources.
We
concluded that it would be necessary to generate
a data base specifically for this purpose.
For the reasons stated above, it was not feasible
to generate a data base using actual costs,
but it was feasible to do one based on charges.
In the absence of valid studies to the contrary,
we think that, for this particular service,
charge data is a reasonable proxy for setting
these maximum fees until we are able to obtain
cost data. Our conclusion is reinforced by
the provision of the statute requiring physicians
to agree not to refuse to vaccinate a child
because of the family's inability to pay the
administration fee and by the knowledge that
many physicians currently either do not bill
indigent patients their full charge or accept
less than full payment from them.
Given
the statutory requirements that the administration
fees not exceed the costs of administration,
we recognize the importance of utilizing cost
data in developing the regional maximum charges.
We also realize that the use of charge data
in developing the maximum charges may result
in maximum charges that are too high. While
it appears that there are no useable cost data
readily available, our goal is to obtain information
that can be used in setting maximum charges
in the future. We will be conducting a study
to accumulate accurate cost data, and will
revise the maximum charges based on cost as
soon as possible.
The
fiscal year 1995 Department of Health and Human
Services appropriations bill specifically addresses
the use of charge versus cost data. (140 Cong.
Rec. H9306, Sept. 20, 1994) The Secretary is
directed to compute the actual cost of administering
vaccines and to revise the fees in accordance
with the requirements of the law. Because the
appropriations bill also states that this directive
is not intended to delay the start-up of the
VFC program, we will utilize the interim maximum
charges. However, as stated above, we will
conduct a study with the goal of obtaining
accurate cost data and will issue revised maximum
charge amounts as soon as possible.
2.
Charge Data Methodology
To
obtain a data base of physician charges, we
contracted with the American Academy of Pediatrics
(AAP) to purchase data on the normal fee charged
by its members for administering the vaccines
to be covered by this program. (We note that
AAP did not believe it could obtain cost data
by directly surveying its membership.) The
AAP had gathered these data from a national,
sample survey of its members. The sample was
large enough (approximately 1,114 responses)
to give us confidence in the national average,
but not large enough in each State to allow
us to set state-by-state maximum charges without
further adjustment. The preliminary results
of the survey indicated that the overall average
administration charge was $14.48. The final
national average administration charge we obtained
from the AAP was $15.09.
In
order to adjust this national average for regional
variations, we concluded that the most reliable
means available was the Geographic Practice
Cost Indices (GPCIs) established for the Medicare
physician fee schedule.
The
GPCI is an index developed by a joint effort
of the Urban Institute (UI) and the Center
for Health Economics Research (CHER) to measure
the differences in resource cost among localities
compared to the national average in the three
components of the relative value units--physician
work, practice expenses, excluding malpractice,
and malpractice. These three components are
weighted 54.2 percent, 40.2 percent, and 5.6
percent, respectively. The resource inputs
and their weights were obtained from the American
Medical Association's (AMA) Socioeconomic Characteristics
of Medical Practice. The weights for the current
GPCIs are from the AMA's l989 Socioeconomic
Monitoring System (SMS) Survey.
If
there is more than one GPCI for a State, we
used the GPCI with the highest values to derive
the maximum charge in order to assure that
the administration charge for providers in
high cost areas would fall within our established
maximum.
The
GPCIs are grouped by State and substate areas.
For purposes of developing the regional maximum
charges, we interpreted the term “regional''
used in the statute to mean “State''
because of the specific grouping of the data
using the GPCIs. While the GPCI is grouped
by State and substate areas, we decided to
use the State grouping only. The geographic
area of a State is clearly identifiable by
boundary lines recognized nationwide, as opposed
to a substate area. In other words, substate
areas do not necessarily represent counties,
which would be an easily identifiable geographic
area. Therefore, we believe using substate
geographic areas would be confusing to both
States and providers.
We
derived the amounts specified in the chart
under section II.C. of this notice as the maximum
charges that may be charged for the administration
of qualified pediatric vaccines for each State
on the basis of the following formula: National
charge data x total weighted GPCI = maximum
charge.
Following
is an example of application of the formula
for Hawaii:
Average
national administration charge = $15.09
Work expense = 1.003
Practice expense = 1.094
Malpractice expense = 1.025
Using
Medicare weights to weigh components of--
Work expense = 54.2 percent
Practice expense = 40.2 percent
Malpractice expense = 5.6 percent
Calculation:
Work expense............ 1.003 x 54.2 % =
.5436
Practice expense........ 1.094 x 40.2 % =
.4398
Malpractice expense.... 1.025 x 5.6
% = .0574
--------
1.0408
Hawaii's maximum charge for administration
of the vaccine is: $15.09 x 1.0408 = $15.71
Given
the circumstances discussed in the beginning
of section II.B. of this notice, the maximum
charge will be based on charge data and will
be applicable until we are able to obtain cost
data. Our goal is to obtain information that
can be used in setting maximum charges in the
future. We will revise the regional maximum
charges as we determine it is necessary, or
in response to public comments.
C.
Maximum Regional Charges for Vaccine Administration
by State
Based
on the methodology described, the maximum administration
charges are as follows:
State |
Regional
maximum charge |
Alabama |
$14.26 |
Alaska\1\ |
17.54 |
Arizona |
15.43 |
Arkansas |
13.30 |
California |
17.55 |
Colorado |
14.74 |
Connecticut\1\ |
16.56 |
Delaware |
15.13 |
District
of Columbia |
16.55 |
Florida |
16.06 |
Georgia |
14.81 |
Hawaii |
15.71 |
Idaho\1\ |
14.34 |
Illinois |
16.79 |
Indiana |
14.47 |
Iowa |
14.58 |
Kansas |
14.80 |
Kentucky |
14.17 |
Louisiana |
15.22 |
Maine\1\ |
14.37 |
Maryland |
15.49 |
Massachusetts\1\ |
15.78 |
Michigan |
16.75 |
Minnesota |
14.69 |
Mississippi |
13.92 |
Missouri |
15.07 |
Montana |
14.13 |
Nebraska |
13.58 |
Nevada |
16.13 |
New
Hampshire\1\ |
14.51 |
New
Jersey |
16.34 |
New
Mexico |
14.28 |
New
York |
17.85 |
North
Carolina\1\ |
13.71 |
North Dakota |
13.90 |
Ohio |
14.67 |
Oklahoma |
13.89 |
Oregon |
15.19 |
Pennsylvania |
15.76 |
Puerto
Rico |
12.24 |
Rhode
Island\1\ |
14.93 |
South
Carolina |
13.62 |
South
Dakota\1\ |
13.56 |
Tennessee |
13.70 |
Texas |
14.85 |
Utah |
14.52 |
Vermont\1\ |
13.86 |
Virginia |
14.71 |
Virgin
Islands |
15.09 |
Washington\1\ |
15.60 |
West
Virginia |
14.49 |
Wisconsin |
15.02 |
Wyoming\1\ |
14.31 |
----------------------------------------------------------
\1\According to available information, these
are Universal Purchase States. The Universal
Purchase States may accept the maximum charges
listed or develop their own maximum fees, as
indicated under section II.D. of this notice.
D.
Maximum Charges for Administration of Vaccines
in Universal Purchase States
States
that have programs under which the State purchases
vaccines for all children in the State (Universal
Purchase States) have the flexibility to accept
the maximum charges developed by HCFA or to
develop their own maximum charges. We believe
it is necessary that Universal Purchase States
are provided sufficient flexibility in developing
charges in order to ensure that there is equal
access to immunizations for all children. In
these States, we believe the State may wish
to set one overall charge cap in order to encourage
adequate provider participation. Furthermore,
it is our understanding that providers should
experience no cost differences between VFC
program eligible children and all other children
inasmuch as the provider never incurs the cost
of the vaccine.
While
Universal Purchase States have the flexibility
to develop their own caps, they must develop
these by utilizing a reasonable methodology
based upon the requirements of section 1928(c)(2)(C)(ii)
of the Act. The amount of the cap is not required
to be set in State law. However, the authority
to set an amount must be based in State law.
E.
Optional Lower Medicaid Administration Fees
State
Medicaid agencies are not obligated to set
the Medicaid payment for vaccine administration
at the level of the maximum charges set forth
in this notice. Section 1928(c)(2)(C)(ii) of
the Act allows them to set their payment at
a lower level, according to their own judgment.
State Medicaid agencies typically set payment
rates taking into consideration a variety of
factors, including the need to assure adequate
participation by providers. Since the maximum
charges in this notice are based on the normal
charges billed by physicians, rather than on
the amounts actually collected by physicians
from insurers or patients, State Medicaid agencies
may determine that a lower payment level is
appropriate.
If
the State Medicaid agency elects to pay a lower
fee, it must provide assurances to HCFA, as
described below, that Medicaid-eligible children
will have access to vaccines. In addition,
a State Medicaid agency may elect to apply
the regional maximum charges in selected areas
of the State and a lower fee in other areas.
Any lower fees that a State Medicaid agency
elects to apply must be justified using the
guidelines specified in section II.F. of this
notice.
In
the case of Universal Purchase States that
elect to develop their own maximum charges,
State Medicaid agencies have the flexibility
to pay the maximum charge or to pay a lower
fee subject to the same provisions discussed
above.
F.
Documentation Guidelines for Optional Lower
Medicaid Administration Fees
1.
Pediatric Services Defined
As
defined in section 1926(a)(4)(B) of the Act,
the term “pediatric services'' means
“services covered under the State plan
provided by a pediatrician, family practitioner,
or certified pediatric nurse practitioner to
children under 18 years of age and does not
include inpatient or outpatient hospital services
or other institutional services.''
2.
Immunization Rate
In
applying any of the guidelines under section
II.F.3. of this notice, we believe it is necessary
to identify what children would be considered
immunized. In order to be counted toward the
immunization rate goals discussed, a child
must have received, within the year period
of measure for access, all immunizations required
for his or her particular age, including those
immunizations under a revised schedule because
of those missed from a previous year.
3.
Data Requirements
If
the State elects to pay an administration fee
lower than the maximum charge set forth in
section II.C. of this notice, it must provide,
via the obstetrical/pediatric State plan amendment
submittal, data that document that the lower
or varying fees meet the statutory requirements
of sections 1902(a)(30)(A) and 1926 of the
Act and the implementing regulatory requirements
of 42 CFR 447.204. Section 447.204 of the regulations
specify that a Medicaid agency's payments must
be sufficient to enlist enough providers so
that services under the plan are available
to recipients at least to the extent that those
services are available to the general population.
The
State may use one or more of the following
guidelines to document that the statutory and
regulatory requirements are met:
a.
Comparison of Ratios
Under
this guideline, the State would submit a comparison
between the following ratios:
(i)
The ratio of the number of children in the
general population immunized to the number
of children in the general population; and
(ii) The ratio of the number of Medicaid
children immunized to the number of Medicaid
children.
In
order for a State to use this guideline as
an equal access assurance, the ratio of Medicaid
children immunized to the number of Medicaid
children would have to be equal to or greater
than the ratio of the general population immunized
to the number of children in the general population.
b.
Comparison to Private Insurance
Another
alternative is for the State to do a comparison
of the Medicaid fees for administration of
pediatric vaccines to the administration fees
paid by a major insurance company.
In
order for the State to use this guideline as
an equal access assurance, the Medicaid rates
for the administration of pediatric vaccines
would have to be set at a rate equal to or
greater than the private insurance company's
rates up to the established State maximum fee.
c.
Practitioner Participation
The
State also may compare:
(i)
The number of Medicaid pediatric practitioners
(which includes practitioners listed in section
1926(a)(4)(B) of the Act) who are Medicaid
program- registered providers and who have
submitted pediatric immunization claims;
and
(ii) The total number of pediatric practitioners
providing immunizations to children.
The
program registered providers must have at least
one Medicaid pediatric immunization claim per
month or an average of 12 such claims during
the year. The State would need 50 percent participation
to show equal access through use of this guideline.
d.
Other
States
have the flexibility to devise alternative
measures of equal access to immunizations.
HCFA will evaluate these other methods by which
States can choose to demonstrate equal access.
G.
Submittal of State Plan Amendments
A
State Medicaid agency must specify the reimbursement
for the administration of pediatric vaccines
(and, if applicable, submit documentation of
equal access) as part of its obstetrical/pediatric
payment rate State Medicaid plan amendment
submittal that are due by April 1 of each year,
beginning April 1, 1995 (and which are effective
July 1, 1995). If the State Medicaid agency
elects to pay the maximum regional amount statewide
(including that established by the State in
Universal Purchase States), it need only specify
this in its State plan amendment submittal
(no additional documentation will be needed).
However, if the State Medicaid agency elects
to vary the vaccine administration fee by geographic
areas within the State, the State must list
the administration fee for each area, and specify
the methodology, and provide the data and methodology
it used to demonstrate equal access to the
vaccines for each geographic area where the
maximum charges are not applied. This documentation
requirement is consistent with the requirements
currently imposed for submittal of State Medicaid
plan amendments for obstetrical and pediatric
payment rates under sections 1902(a)(30)(A)
and 1926 of the Act. We also believe that documenting
access to immunizations by each geographic
area provides a more accurate picture of access
and areas where access is problematic.
The
State plan amendment must be submitted by December
31, 1994 and be effective on October 1, 1994.
For the interim period of October 1, 1994 through
March 31, 1995, States may claim Federal matching
funds for the costs of administration of vaccines
to Medicaid-eligible children using the maximum
charges or the lower fees established on the
basis of the guidance provided in this notice.
For this interim State plan amendment, the
State will not be required to submit the data
to document access to immunizations but will
be required to list the methodology by which
Medicaid beneficiary access to immunizations
is assured. Beginning April 1, 1995, documentation
of equal access to immunizations will be required
to be included as part of the yearly Obstetrical/Pediatric
State plan amendment submittal in accordance
with section 1926 of the Act.
III.
Impact Statement
For
notices such as this, we generally prepare
a flexibility analysis that is consistent with
the Regulatory Flexibility Act (RFA) (5 U.S.C.
601 through 612), unless the Secretary certifies
that a notice will not have a significant economic
impact on a substantial number of small entities.
For purposes of a RFA, States and individuals
are not considered small entities. However,
providers are considered small entities.
In
addition, section 1102(b) of the Act requires
the Secretary to prepare a regulatory impact
analysis for any notice of proposed rulemaking
that may have a significant impact on the operation
of a substantial number of small rural hospitals.
Such an analysis must conform to the provisions
of section 604 of the RFA. For purposes of
section 1102(b) of the Act, we define a small
rural hospital as a hospital that is located
outside of a Metropolitan Statistical Area
and has fewer than 50 beds.
This
notice with comment period implements a provision
of section 1928 of the Act. Specifically, this
notice with comment period announces interim
regional maximum charges that providers may
impose for administering pediatric vaccines
to Federally vaccine-eligible children under
the VFC Program. Section 1928 of the Act directs
the Secretary to establish regional maximum
fees. As discussed in section II. B of this
notice, HCFA contracted with the American Academy
of Pediatrics to conduct a survey to obtain
national charge data for the administration
of pediatric vaccines. HCFA used this data
to develop a national charge amount and then
adjusted this amount to take into account regional
variations to establish a charge for each State.
The GPCIs established for the Medicare physician
fee schedule were used to make this adjustment.
Universal Purchase States have the flexibility
to accept the maximum charges developed by
HCFA or to develop their own maximum charges.
HCFA is also permitting State Medicaid agencies
to develop a lower administration fee than
the maximum charge if they can demonstrate
equal access for children to the vaccines.
The
impact of implementing the provision of section
1928(c)(2)(C)(ii) of the Act is discussed further
below. We do not believe that this provision
will have a significant effect on a substantial
number of small entities.
To
the extent that a legislative provision being
implemented by a notice such as this may have
a significant effect on recipients or providers
or may be viewed as controversial, we believe
that we should address any potential concerns.
In this instance, it is difficult to predict
what the fiscal impact of this notice will
be. There are several unknown factors. Among
them are the number of program-eligible providers
who will elect to administer the vaccines.
In addition, State Medicaid agencies are not
required to pay the maximum charges. State
Medicaid agencies may establish and apply lower
vaccine administration fees if they document
that Medicaid children have access to immunizations
to the same extent as the general population.
Given the availability of free vaccines and
the fact that State payments for all pediatric
and obstetrical services, including, presumably,
vaccine administration, have for some time
been subject to access demonstration requirements
under 42 CFR 447.204 and sections 1902(a)(30)(A)
and 1926 of the Act, we believe that a large
proportion of States will be able to demonstrate
equal access for Medicaid-eligible children
at rates lower than the maximum charges. In
addition, should a State Medicaid agency not
be able to demonstrate equal access at its
current rates, the State Medicaid agency would
only have to increase its rates to where there
would be equal access. The publication of the
maximum charge schedule will certainly create
pressure in States with vaccine administration
fees for Medicaid-eligible children lower than
the maximums to raise those fees. However,
to the extent that these States can provide
the required assurances, they will not need
to raise their fees. (Currently, it appears
that most States pay for vaccine administration
under Medicaid at rates well below the proposed
maximum. This is allowable under the statute.)
Hence,
the magnitude of any increase in Medicaid outlays
is difficult to ascertain. Because of the pre-existing
equal access demonstration requirements, we
find it hard to estimate how much of any increase
in charges would be attributable to the specific
guidelines of this notice and how much would
occur without publication of the notice. We
invite public comment on the impact of both
the equal access assurances and anticipated
fee increases.
We
are providing a voluntary regulatory flexibility
analysis because of the large number of children
and providers who may be affected. Normally,
a regulatory flexibility analysis requires
the agency to discuss various alternatives
to the provisions in a notice. As discussed
above, however, HCFA is implementing the provisions
of section 1928(c)(2)(C)(ii) of the Act. The
focus of this legislation is upon expanding
the number of children who are eligible to
receive free pediatric vaccines. We have provided
State Medicaid agencies with an option of using
a lower fee than the maximum charges set forth
in this notice or using a charge established
by a Universal Purchase State at their option
if they can demonstrate equal access of children
to the pediatric vaccines. Because indicated
Congressional intent was to expand the coverage
for vaccines, we believe that permitting State
Medicaid agencies to use a lower fee where
they can demonstrate equal access of children
to the pediatric vaccines is consistent with
the statute. In addition, we note that this
option, if utilized by State Medicaid agencies,
will cost Federal and State governments less
money than if the State Medicaid agencies were
using the maximum regional charges as set forth
in this notice, while simultaneously achieving
Congress' goal.
A
brief summary of the impact of the provisions
of this notice with comment period upon various
groups is provided below.
1.
Providers
Each
program-registered provider who administers
a qualified pediatric vaccine is entitled to
receive the vaccine without charge either for
the vaccine or its delivery to the provider.
This notice specifically establishes maximum
regional charges for providers to administer
the vaccines. As a result of these maximum
regional charges, we believe that the number
of providers who may be willing to administer
the vaccines would be maintained or increased.
In addition to a potential increase in the
number of providers who may be willing to administer
these vaccines, there may be an increase in
the number of patients that they treat since
section 1928 of the Act expands the number
of children who are eligible to receive the
vaccine without charge.
2.
Children
The
greatest benefit of this provision is that
it expands the number of children who are eligible
to receive pediatric vaccines without charge
for the vaccines. We believe that there will
be an increase in the number of children receiving
pediatric vaccines. As the number of children
who are vaccinated increases, we believe that
savings will accrue as a result of a decline
in the number of children who will require
treatment for vaccine-preventable illnesses.
3.
States
States
may also benefit under various provisions of
the VFC Program. Specifically, this program
will provide free vaccines and free delivery
to States thus saving States monies that would
otherwise be spent on purchase and delivery
of vaccines. Where they can demonstrate equal
access, State Medicaid agencies are given the
option of using the regional charge as specified
in this notice or a lower fee. States could
experience an increase in the number of children
who are receiving the vaccines, thus achieving
Congress' goal though increasing their pediatric
immunization costs. As discussed above, fewer
children may be treated for vaccine-preventable
illnesses which may provide a savings to the
States.
We
are not preparing a rural impact statement
since we have determined, and the Secretary
has certified, that this notice with comment
period will not have a significant impact on
the operations of a substantial number of small
rural hospitals.
In
accordance with the provisions of Executive
Order 12866, this notice was reviewed by the
Office of Management and Budget.
(Catalog
of Federal Domestic Assistance Program No.
93.778, Medical Assistance Program)
Dated:
September 2, 1994.
Bruce
C. Vladeck,
Administrator, Health Care Financing Administration.
Dated:
September 23, 1994
Donna
E. Shalala, Secretary.
[FR
Doc. 94-24433 Filed 9-30-94; 8:45 am]
BILLING CODE 4120-01-P
|