Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Notices 21195

value of pursuing such agreements with

selected foreign regulatory bodies in its

1992 ‘‘Report of the Task Force on

International Harmonization.’’ The task

force concluded that the development of

memoranda of understanding (MOU’s)

is an effective means of facilitating

international harmonization; of ensuring

the safety, efficacy, and/or quality of

products that are offered for import into

the United States; and of efficiently

using agency inspectional resources.

The task force, however, cautioned that

the negotiation of MOU’s must be with

foreign regulatory agencies that have

appropriate authority and expertise to

ensure the proper implementation of

any MOU that may be agreed upon. A

properly conceived and executed

agreement with the European

Commission would permit the use of EU

Member State government inspectional

information to assist FDA in its

regulatory decisionmaking and could

help to set priorities for foreign

inspection or import surveillance

programs. Early initiatives to pursue an

MOU with the European Commission

did not receive high priority by either

side. Recently the MRA talks have

served as a catalyst for reinvigorating

these discussions.

The talks have been led by USTR and

DOC with the Directorate-General I as

their counterpart office in the European

Commission. There have been six

rounds of talks to date, beginning in

April 1994. The most recent round of

talks was held in Washington, DC, from

November 13 through 15, 1995. FDA has

participated in each round of

discussions.

To provide an opportunity for public

input into the pharmaceutical GMP

discussions with the European

Commission and the Member States,

FDA hosted a public exchange meeting

on March 31, 1995. The meeting was

attended by approximately 40 persons

representing the drug and biologics

industries, consultants, and other

organizations. Attendees expressed

support for, as well as concerns

regarding, the proposed agreement.

A delegation of FDA officials attended

a pharmaceutical GMP workshop hosted

by the European Commission in

Brussels from April 3 to 5, 1995. The

purpose of the meeting was to exchange

information on inspection programs in

the United States and the EU, and how

each of the EU Member States carries

out its role. The Canadian Health

Protection Branch also attended the

meeting and made a presentation on

their pharmaceutical GMP program. At

the conclusion of the workshop it was

agreed that further cooperative efforts

are needed before we could develop an

MRA or MOU. Such efforts could

include exchange of inspection reports,

joint inspections, joint training of

inspectors, and development of a joint

inventory of facilities requiring

inspection.

Also, following the conclusion of the

workshop, industry representatives from

the EU and the United States were

invited to express their views. Both

sides expressed support for an

agreement. The U.S. pharmaceutical

industry generally expressed the desire

for a harmonized approach. The EU

pharmaceutical industry expressed a

desire for an approach that provided for

mutual recognition of the current

systems.

On May 1, 1995, a delegation of FDA

officials also participated in meetings

with EU officials and notified body

representatives to allow both sides to

better understand their respective

medical device regulatory regimes. In

addition to useful exchange of

information and ‘‘confidence building,’’

the meetings helped to clarify several

technical issues related to an MRA on

medical devices.

Through this notice, FDA is

establishing a public docket in order to

make available at a convenient location

certain information concerning its

participation in these bilateral MRA

talks. Information currently contained

in this public docket includes the

following:

Minutes of the FDA-sponsored public

exchange meeting held on March 31, 1995.

Agenda of FDA-sponsored public exchange

meeting held on March 31, 1995.

Statements of participants presented at the

FDA-sponsored public exchange meeting

held on March 31, 1995.

Summary of the April 3 through 5, 1995,

Pharmaceutical GMP Workshop in Brussels.

Summary of the July 10 through 12, 1995,

MRA talks in Brussels concerning

pharmaceutical GMP’s.

FDA summary of November 13 through 15,

1995, round of negotiations.

Presentation of Walter Batts entitled

‘‘Mutual Recognition Agreement Negotiations

with EU re: Pharmaceutical GMP’s-FDA’s

Perspective,’’ February 13, 1996.

Dated: May 1, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–11517 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[MB–098–N]

Medicaid Program; Limitations on

Aggregate Payments to

Disproportionate Share Hospitals:

Federal Fiscal Year 1996

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

preliminary Federal fiscal year (FFY)

1996 national target and individual

State allotments for Medicaid payment

adjustments made to hospitals that serve

a disproportionate number of Medicaid

recipients and low-income patients with

special needs. We are publishing this

notice in accordance with the

provisions of section 1923(f)(1)(C) of the

Social Security Act and implementing

regulations at 42 CFR 447.297 through

447.299. The preliminary FFY 1996

State disproportionate share hospital

(DSH) allotments published in this

notice will be superseded by final FFY

1996 DSH allotments to be published in

the Federal Register subsequent to the

publication of this notice.

EFFECTIVE DATE: The preliminary DSH

payment adjustment expenditure limits

included in this notice apply to

Medicaid DSH payment adjustments

that are applicable to FFY 1996.

FOR FURTHER INFORMATION CONTACT:

Richard Strauss, (410) 786–2019.

SUPPLEMENTARY INFORMATION:

I. Background

Section 1902(a)(13)(A) of the Social

Security Act (the Act) requires States to

ensure that their Medicaid payment

rates include payment adjustments for

Medicaid-participating hospitals that

serve a large number of Medicaid

recipients and other low-income

individuals with special needs (referred

to as disproportionate share hospitals

(DSHs)). The payment adjustments are

calculated on the basis of formulas

specified in section 1923 of the Act.

Section 1923(f) of the Act and

implementing Medicaid regulations at

42 CFR 447.297 through 447.299 require

us to estimate and publish in the

Federal Register the national target and

each State’s allotment for DSH

payments for each Federal fiscal year

(FFY). The implementing regulations

provide that the national aggregate DSH

limit for a FFY specified in the Act is

a target rather than an absolute cap

when determining the amount that can

be allocated for DSH payments. The

national DSH target is 12 percent of the

total amount of medical assistance
21196 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Notices

expenditures (excluding total

administrative costs) that are projected

to be made under approved Medicaid

State plans during the FFY. (Note:

Whenever the phrases ‘‘total medical

assistance expenditures’’ or ‘‘total

administrative costs’’ are used in this

notice, they mean both the State and

Federal share of expenditures or costs.)

In addition to the national DSH target,

there is a specific State DSH limit for

each State for each FFY. The State DSH

limit is a specified amount of DSH

payment adjustments applicable to a

FFY above which FFP will not be

available. This is called the ‘‘State DSH

allotment’’.

Each State’s DSH allotment for FFY

1996 is calculated by first determining

whether the State is a ‘‘high-DSH State,’’

or a ‘‘low-DSH State.’’ This is

determined by using the State’s ‘‘base

allotment.’’ A State’s base allotment is

the greater of the following amounts: (1)

the total amount of the State’s actual

and projected DSH payment

adjustments made under the State’s

approved State plan applicable to FFY

1992, as adjusted by HCFA; or (2)

$1,000,000.

A State whose base allotment exceeds

12 percent of the State’s total medical

assistance expenditures (excluding

administrative costs) projected to be

made in FFY 1996 is referred to as a

‘‘high-DSH State.’’ The FFY 1996 State

DSH allotment for a high-DSH State is

limited to the State’s base allotment.

A State whose base allotment is equal

to or less than 12 percent of the State’s

total medical assistance expenditures

(excluding administrative costs)

projected to be made in FFY 1996 is

referred to as a ‘‘low-DSH State.’’ The

FFY 1996 State DSH allotment for a

low-DSH State is equal to the State’s

DSH allotment for FFY 1995 increased

by growth amounts and supplemental

amounts, if any. However, the FFY 1996

DSH allotment for a low-DSH State

cannot exceed 12 percent of the State’s

total medical assistance expenditures

for FFY 1996 (excluding administrative

costs).

A State that is classified as a highDSH State for one year, because its base

allotment exceeds 12 percent of its total

medical assistance expenditures for that

year, may not continue to meet the highDSH State definition in other years.

That is, if the State’s base allotment for

another year is equal to or less than 12

percent of its total medical assistance

for that year, the State would be

classified as a low-DSH State for that

year. As a low-DSH State, the State

could potentially receive growth for that

year.

The growth amount for FFY 1996 is

equal to the projected percentage

increase (the growth factor) in a lowDSH State’s total Medicaid program

expenditures between FFY 1995 and

FFY 1996 multiplied by the State’s final

DSH allotment for FFY 1995. Because

the national DSH limit is considered a

target, low-DSH States whose programs

grow from one year to the next can

receive a growth amount that would not

be permitted if the national limit was

viewed as an absolute cap.

There is no growth factor and no

growth amount for any low-DSH State

whose Medicaid program does not grow

(that is, stayed the same or declined)

between FFY 1995 and FFY 1996.

Furthermore, because a low-DSH State’s

FFY 1996 DSH allotment cannot exceed

12 percent of the State’s total medical

assistance expenditures, it is possible

for its FFY 1996 DSH allotment to be

lower than its FFY 1995 DSH allotment.

For example, this occurs when the State

experiences a decrease in its program

expenditures between FFY 1995 and

FFY 1996 and its 1995 FFY DSH

allotment is greater than 12 percent of

the total projected medical assistance

expenditures for the current FFY. This

is the case for the State of Rhode Island

for FFY 1996.

There is no supplemental amount

available for redistribution for FFY

1996. The supplemental amount, if any,

is equal to a low-DSH State’s

proportional share of a pool of funds

(the redistribution pool). The

redistribution pool is equal to the

national 12-percent DSH target reduced

by the total of the base allotments for

high-DSH States, the total of the State

DSH allotments for the previous FFY for

low-DSH States, and the total of the

low-DSH State growth amounts. Since

the sum of these amounts is above the

projected FFY 1996 national 12-percent

DSH target, there is no redistribution

pool and, therefore, no supplemental

amounts for FFY 1996.

As prescribed in the law and

regulations, no State’s DSH allotment

will be below a minimum of $1,000,000.

As an exception to the above

requirements, under section

1923(f)(1)(A)(I)(II) of the Act and

regulations at 42 CFR 447.296(b)(5) and

447.298(f), a State may make DSH

payments for a FFY in accordance with

the minimum payment adjustments

required by Medicare methodology

described in section 1923(c)(1) of the

Act. The State of Nebraska’s preliminary

State DSH allotment has been

determined in accordance with this

exception.

We are publishing in this notice the

preliminary FFY 1996 national DSH

target and State DSH allotments based

on the best available data we received

from the States’ August 1995

submissions of the Medicaid budget

report (Form HCFA–37), as adjusted by

HCFA. We intend to publish the final

FFY 1996 DSH allotments in the

Federal Register subsequent to the

publication of this notice.

The final allotments are calculated

using actual Medicaid expenditures for

FFY 1995 as reported to HCFA on

States’ quarterly expenditure reports

(Form HCFA–64) for FFY 1995 and

estimates of Medicaid expenditures for

FFY 1996 as reported to HCFA on

States’ Form HCFA–37 February 1996

submissions.

II. Calculations of the Preliminary FFY

1996 DSH Limits

The total of the preliminary State DSH

allotments for FFY 1996 is equal to the

sum of the base allotments for all highDSH States, the FFY 1995 State DSH

allotments for all low-DSH States, and

the growth amounts for all low-DSH

States. A State-by-State breakdown is

presented in section III of this notice.

We classified States as high-DSH or

low-DSH States. If a State’s base

allotment exceeded 12 percent of its

total unadjusted medical assistance

expenditures (excluding administrative

costs) projected to be made under the

State’s approved plan under title XIX of

the Act in FFY 1996, we classified that

State as a ‘‘high-DSH’’ State. If a State’s

base allotment was 12 percent or less of

its total unadjusted medical assistance

expenditures projected to be made

under the State’s approved plan under

title XIX of the Act in FFY 1996, we

classified that State as a ‘‘low-DSH’’

State. Based on this classification, there

are 36 low-DSH States and 14 high-DSH

States for FFY 1996.

Using the most recent data from the

States’ August 1995 budget projections

(Form HCFA–37), we estimate the

States’ FFY 1996 national total medical

assistance expenditures to be

$160,184,881,000. Thus, the overall

preliminary national FFY 1996 DSH

expenditure target is $19,222,186,000

(12 percent of $160,184,881,000).

In the preliminary FFY 1996 State

DSH allotments, we provide a total of

$519,764,000 ($310,963,000 Federal

share) in growth amounts for the 36

low-DSH States. The growth factor

percentage for each of the low-DSH

States was determined by calculating

the Medicaid program growth

percentage for each low-DSH State

between FFY 1995 and FFY 1996. To

compute this percentage, we first

ascertained each low-DSH State’s total

FFY 1995 medical assistance and
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Notices 21197

administrative expenditures as reported

on the State’s August 15, 1995,

submission of the Medicaid Budget

Report (Form HCFA–37) through the

‘‘cutoff’’ date of September 8, 1995. The

cutoff date is the date through which the

August 1995 Medicaid budget report

submission estimates are accepted and

applied in preparing the States’

Medicaid grant award for the upcoming

quarter (October through December

1995). Next, we compared those

estimates to each low-DSH State’s total

estimated unadjusted FFY 1996 medical

assistance and administrative

expenditures as reported to HCFA on

the States’ August 1995 Form HCFA–37

submission.

The growth factor percentage was

multiplied by the low-DSH States’ final

FFY 1995 DSH allotment amount to

establish the States’ preliminary growth

amount for FFY 1996.

Since the sum of the total of the base

allotments for high-DSH States, the total

of the State DSH allotments for the

previous FFY for low-DSH States, and

the growth for low- DSH States

($19,602,716,000) is greater than the

preliminary FFY 1996 national target

($19,222,186,000), there is no

preliminary FFY 1996 redistribution

pool.

The low-DSH States’ growth amount

was then added to the low-DSH States’

final FFY 1995 DSH allotment amount

to establish the preliminary total lowDSH State DSH allotment for FFY 1996.

If a State’s growth amount, when added

to its final FFY 1995 DSH allotment

amount, exceeds 12 percent of its FFY

1996 estimated medical assistance

expenditures, the State only receives a

partial growth amount that, when added

to its final FFY 1995 allotment, limits its

total State DSH allotment for FFY 1996

to 12 percent of its estimated FFY 1996

medical assistance expenditures. For

this reason, six of the low-DSH States

received partial growth amounts.

As explained above, Rhode Island’s

preliminary FFY 1996 DSH allotment is

lower than its final FFY 1995 DSH

allotment. Also, in accordance with the

minimum payment adjustments

required by Medicare methodology,

Nebraska’s FFY 1996 State DSH

allotment is $11,000,000.

In summary, the total of all

preliminary State DSH allotments for

FFY 1996 is $19,602,716,000

($11,137,851,000 Federal share). This

total is composed of the prior FFY’s

final State DSH allotments

($19,084,239,000) plus growth amounts

for all low-DSH States ($519,764,000),

minus the amount of reduction in

Rhode Island’s FFY 1996 DSH allotment

($1,286,000), plus supplemental

amounts for low-DSH States ($0). The

total of all preliminary FFY 1996 State

DSH allotments is 12.2 percent of the

total medical assistance expenditures

(excluding administrative costs)

projected to be made by these States in

FFY 1996. The total of all preliminary

DSH allotments for FFY 1996 is

$380,531,000 over the FFY 1996

national target amount of

$19,222,186,000.

Each State should monitor and make

any necessary adjustments to its DSH

spending during FFY 1996 to ensure

that its actual FFY 1996 DSH payment

adjustment expenditures do not exceed

its preliminary State DSH allotment for

FFY 1996 published in this notice. As

the ongoing reconciliation between

actual FFY 1996 DSH payment

adjustment expenditures and the FFY

1996 DSH allotments takes place, each

State should amend its plan as may be

necessary to make any adjustments to its

FFY 1996 DSH payment adjustment

expenditure patterns so that the State

will not exceed its FFY 1996 DSH

allotment.

The FFY 1996 reconciliation of DSH

allotments to actual expenditures will

take place on an ongoing basis as States

file expenditure reports with HCFA for

DSH payment adjustment expenditures

applicable to FFY 1996. Additional DSH

payment adjustment expenditures made

in succeeding FFYs that are applicable

to FFY 1996 will continue to be

reconciled with each State’s FFY 1996

DSH allotment as additional

expenditure reports are submitted to

ensure that the FFY 1996 DSH allotment

is not exceeded. As a result, any DSH

payment adjustment expenditures for

FFY 1996 in excess of the FFY 1996

DSH allotment will be disallowed; and

therefore, subject to the normal

Medicaid disallowance procedures.

III. Preliminary FFY 1996 DSH

Allotments Under Public Law 102–234

Key to Chart:

Column/Description

Column A = Name of State

Column B = Final FFY 1995 DSH

Allotments for All States. For a highDSH State, this is the State’s base

allotment, which is the greater of the

State’s FFY 1992 allowable DSH

payment adjustment expenditures

applicable to FFY 1992, or

$1,000,000. For a low-DSH State, this

is equal to the final DSH allotment for

FFY 1995, which was published in

the Federal Register on September 8,

1995.

Column C = Growth Amounts for LowDSH States. This is an increase in a

low-DSH State’s final FFY 1995 DSH

allotment to the extent that the State’s

Medicaid program grew between FFY

1995 and FFY 1996.

Column D = Preliminary FFY 1996 State

DSH Allotments. For high-DSH States,

this is equal to the base allotment

from column B. For low-DSH States,

this is equal to the final State DSH

allotments for FFY 1995 from column

B plus the growth amounts from

column C.

Column E = High- or Low- DSH State

Designation for FFY 1996. ‘‘High’’

indicates the State is a high-DSH State

and ‘‘Low’’ indicates the State is a

low-DSH State.

IV. Regulatory Impact Statement

We generally prepare a regulatory

flexibility analysis that is consistent

with the Regulatory Flexibility Act

(R.A.) (5 U.S.C. 601 through 612), unless

we certify that a notice would not have

a significant economic impact on a

substantial number of small entities. For

purposes of an R.A., States and

individuals are not considered small

entities. However, providers are

considered small entities. Additionally,

section 1102(b) of the Act requires us to

prepare a regulatory impact analysis if

a notice may have a significant impact

on the operations of a substantial

number of small rural hospitals. Such

an analysis must conform to the

provisions of section 604 of the R.A. 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 sets forth no changes in

our regulations; rather, it reflects the

DSH allotments for each State as

determined in accordance with

§§ 447.297 through 447.299.

We have discussed the method of

calculating the preliminary FFY 1996

national aggregate DSH target and the

preliminary FFY 1996 individual State

DSH allotments in the previous sections

of this notice. These calculations should

have a positive impact on payments to

DSHs. Allotments will not be reduced

for high-DSH States since we interpret

the 12-percent limit as a target. LowDSH States will get their prior FFY DSH

allotments plus their growth amounts.

In accordance with the provisions of

Executive Order 12886, this notice was

reviewed by the Office of Management

and Budget.

(No. 93.778, Medical Assistance Program)
21198 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Notices

Dated: February 21, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: April 5, 1996.

Donna E. Shalala,

Secretary.

[FR Doc. 96–11627 Filed 5–8–96; 8:45 am]

BILLING CODE 4120–01–P

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995 for

opportunity for public comment on

proposed data collection projects, the

Health Resources and Services

Administration (HRSA) will publish

periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, call the HRSA

Reports Clearance Officer on (301) 443–

1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Projects

Organ Procurement and

Transplantation Network (OPTN) Data

System

(OMB No. 0915–0157)—Extension

and Revision—The data collection

system of the OPTN and Scientific

Registry provides for collection of data

on organ transplantation, including

heart, kidney, liver, heart-lung, pancreas

and small intestine transplants. The

OPTN data collection is required under

Section 372 of the Public Health Service

Act and includes data on pre-transplant

activities. This includes cadaveric and

live donor characteristics, and

histocompatibility testing that is used in

the matching of donor organs with

recipients. Section 373 of the Public

Health Service Act requires the

Scientific Registry to collect, analyze

and report on clinical and scientific data

of importance to post-transplant graft

and patient function. This involves a

routine, periodic, submission of data for

each organ transplant patient at the time

of transplant, one-year (or six months

for heart transplant patients), and

annually post-transplant until graft

failure or patient death.

Information and data collected by the

OPTN and Scientific Registry are used

primarily to analyze policies for the

allocation of donor organs, and to assess

the clinical outcomes of transplantation.

The data are also used by the

committees and Board of Directors of

the OPTN for developing and reviewing

policies related to allocation, patient

listing criteria, optimal organ

preservation times, and infectious

disease screening.

Respondents include organ

procurement organizations (for

cadaveric donor data),

histocompatibility laboratories (for

tissue typing data), and transplant

hospitals (for pre- and post-transplant

data on recipients). The data are used to

issue two key reports—the Annual Data

Report and the Report of Patient and

Graft Survival Rates (issued biennially).

HRSA proposes to make only minor

changes to the data elements to obtain

more detailed information on transplant

patients and their post-clinical course.

For example, additional categories will

be added to several items on the forms.

HRSA invites comments on these and

other possible changes to the OPTN and

Scientific Registry datasets.

The estimated annual response

burden is as follows:

Form Type Number of

respondents

No. of responses per

respondent

Total responsesHours per responseTotal burden hours

1. Cadaver Donor Registration/Referral ................................................. 69 217 15,000 1 0.2 3,000

2. Living Donor Registration ................................................................... 69 54 3,700 0.2 740

3. Donor Histocompatibility ..................................................................... 51 196 10,000 0.1 1,000

4. Potential Recipient Form .................................................................... 69 275 19,000 0.1 1,900

5. Recipient Histocompatibility ................................................................ 51 392 20,000 0.1 2,000

6. Transplant Candidate Registration ..................................................... 69 638 44,000 0.1 4,400

7. Thoracic Registration .......................................................................... 166 21 3,500 0.3 1,050

8. Thoracic Follow-Up ............................................................................. 166 101 16,800 0.3 5,040

9. Kidney Registration ............................................................................ 248 49 12,200 0.3 3,660

10. Kidney Follow-Up ............................................................................. 248 399 111,000 2 0.2 22,200

11. Liver Registration .............................................................................. 119 34 4,000 0.4 1,600

12. Liver Follow-Up ................................................................................. 119 176 21,000 0.4 8,400

13. Pancreas Registration ...................................................................... 120 8 1,000 0.2 200

14. Pancreas Follow-Up ......................................................................... 120 34 4,100 0.2 820

15. Intestine Registration ........................................................................ 26 4 100 0.2 20

16. Intestine Follow-Up ........................................................................... 26 8 200 0.2 40

Total ........................................................................................................ 799 357 285,600 20 56,070

1 It is estimated that 15,000 of these forms will be completed each year but approximately 9,500 will be referrals only. For those patients, only

the first page of the form and one question on the second page will be completed. The average completion time for all 14,000 forms is 0.2 hours. 2 Includes an estimated 20,000 kidney transplant patients, transplanted prior to the initiation of the data system, October 1, 1987.