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VFC: Federal Register

Note: The fee table was published in the Federal Register on October 3, 1994 and remains unchanged as of Dec. 2003.

Summary

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-

• Who are eligible for Medicaid;
• Who are not insured under any form of health insurance;
• 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
• 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-

• 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;
• Submits to the State an executed provider agreement in the form and manner specified by the Secretary; and
• 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
Total: 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:

1. Comparison of Ratios
   
   Under this guideline, the State would submit a comparison between the following ratios:
   
   
   1. The ratio of the number of children in the general population immunized to the number of children in the general population; and
   2. 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.



2. 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.



3. Practitioner Participation
   
   The State also may compare:
   
   
   1. 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
   2. 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.



4. 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

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