18930 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 

administer any RCRA hazardous waste 

permits or portions of permits which we 

issued prior to the effective date of this 

authorization. We will not issue any 

more new permits or new portions of 

permits for the provisions listed in the 

Table in this document after the 

effective date of this authorization. The 

EPA will continue to implement and 

issue permits for HSWA requirements 

for which Oklahoma is not yet 

authorized. 

J. How does today’s action affect Indian 

country (8 U.S.C. 1151) in Oklahoma? 

The State of Oklahoma Hazardous 

Program is not being authorized to 

operate in Indian Country. 

K. What is codification and is the EPA 

codifying Oklahoma’s hazardous waste 

program as authorized in this rule? 

Codification is the process of placing 

the State’s statutes and regulations that 

comprise the State’s authorized 

hazardous waste program into the CFR. 

We do this by referencing the 

authorized State rules in 40 CFR part 

272. We reserve the amendment of 40 

CFR part 272, subpart LL for this 

authorization of Oklahoma’s program 

changes until a later date. In this 

authorization application the EPA is not 

codifying the rules documented in this 

Federal Register notice. 

L. Administrative Requirements 

The Office of Management and Budget 

(OMB) has exempted this action from 

the requirements of Executive Order 

12866 (58 FR 51735, October 4, 1993), 

and therefore this action is not subject 

to review by OMB. The reference to 

Executive Order 13563 (76 FR 3821, 

January 21, 2011) is also exempt from 

review under Executive orders 12866 

(56 FR 51735, October 4, 1993). This 

action authorizes State requirements for 

the purpose of RCRA 3006 and imposes 

no additional requirements beyond 

those imposed by State law. 

Accordingly, I certify that this action 

will not have a significant economic 

impact on a substantial number of small 

entities under the Regulatory Flexibility 

Act (5 U.S.C. 601 et seq.). Because this 

action authorizes preexisting 

requirements under State law and does 

not impose any additional enforceable 

duty beyond that required by State law, 

it does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4). For the same 

reason, this action also does not 

significantly or uniquely affect the 

communities of Tribal governments, as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). This 

action will not have substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in Executive Order 13132 (64 

FR 43255, August 10, 1999), because it 

merely authorizes State requirements as 

part of the State RCRA hazardous waste 

program without altering the 

relationship or the distribution of power 

and responsibilities established by 

RCRA. This action also is not subject to 

Executive Order 13045 (62 FR 19885, 

April 23, 1997), because it is not 

economically significant and it does not 

make decisions based on environmental 

health or safety risks. This rule is not 

subject to Executive Order 13211, 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355 (May 

22, 2001)) because it is not a significant 

regulatory action under Executive Order 

12866. 

Under RCRA 3006(b), the EPA grants 

a State’s application for authorization as 

long as the State meets the criteria 

required by RCRA. It would thus be 

inconsistent with applicable law for the 

EPA, when it reviews a State 

authorization application to require the 

use of any particular voluntary 

consensus standard in place of another 

standard that otherwise satisfies the 

requirements of RCRA. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. As required by 

section 3 of Executive Order 12988 (61 

FR 4729, February 7, 1996), in issuing 

this rule, the EPA has taken the 

necessary steps to eliminate drafting 

errors and ambiguity, minimize 

potential litigation, and provide a clear 

legal standard for affected conduct. The 

EPA has complied with Executive Order 

12630 (53 FR 8859, March 15, 1988) by 

examining the takings implications of 

the rule in accordance with the 

‘‘Attorney General’s Supplemental 

Guidelines for the Evaluation of Risk 

and Avoidance of Unanticipated 

Takings’’ issued under the Executive 

Order. This rule does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.). The 

Congressional Review Act, 5 U.S.C. 801 

et seq., as added by the Small Business 

Regulatory Enforcement Fairness Act of 

1996, generally provides that before a 

rule may take effect, the agency 

promulgating the rule must submit a 

rule report, which includes a copy of 

the rule, to each House of the Congress 

and to the Comptroller General of the 

United States. The EPA will submit a 

report containing this document and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication in the Federal Register. A 

major rule cannot take effect until 60 

days after it is published in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). This 

action will be effective June 6, 2011. 

List of Subjects in 40 CFR Part 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous waste, Hazardous waste 

transportation, Indian lands, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements. 

Authority: This action is issued under the 

authority of sections 2002(a), 3006, and 

7004(b) of the Solid Waste Disposal Act as 

amended 42 U.S.C. 6912(a), 6926, 6974(b). 

Dated: March 19, 2011. 

Al Armendariz, 

Regional Administrator, Region 6. 

[FR Doc. 2011–8169 Filed 4–5–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 413 

[CMS–1435–IFC] 

RIN 0938–AQ94 

Medicare Programs: Changes to the 

End-Stage Renal Disease Prospective 

Payment System Transition BudgetNeutrality Adjustment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule with 

comment will revise the end-stage renal 

disease (ESRD) transition budgetneutrality adjustment finalized in the 

CY 2011 ESRD Prospective Payment 

System (PPS) final rule for renal dialysis 

services provided on April 1, 2011 

through December 31, 2011. We are 

revising the transition budget-neutrality 

adjustment to reflect the actual election 

decision to receive payment under the 

ESRD PPS for renal dialysis services 

furnished on or after January 1, 2011 


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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 18931 

made by ESRD facilities, rather than 

projected elections using the same 

methodology as described in the ESRD 

PPS proposed and final rules. This 

results in a zero percent adjustment for 

renal dialysis services furnished April 1, 

2011 through December 31, 2011. 

DATES: Effective date: April 1, 2011. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

June 6, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–1435–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed) 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–1435–IFC, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–1435–IFC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: a. For delivery in 

Washington, DC—Centers for Medicare 

& Medicaid Services, Department of 

Health and Human Services, Room 445– 

G, Hubert H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Terri Deutsch, (410) 786–9462. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://regulations.gov. 

Follow the search instructions on that 

Web site to view public comments. 

Comments received timely will be 

also available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

A. Establishment of the ESRD PPS 

Transition Budget-Neutrality 

Adjustment 

On August 12, 2010, we published a 

final rule (75 FR 49030 through 49214) 

in the Federal Register, entitled 

‘‘Medicare Program; End-Stage Renal 

Disease Prospective Payment System’’, 

hereinafter, referred to as the CY 2011 

ESRD PPS final rule. In the CY 2011 

ESRD PPS final rule, we implemented a 

case-mix adjusted bundled prospective 

payment system (PPS) for Medicare 

outpatient end-stage renal disease 

(ESRD) dialysis services furnished 

beginning January 1, 2011, in 

accordance with the statutory 

provisions set forth in section 153(b) of 

the Medicare Improvements for Patients 

and Providers Act of 2008 (MIPPA). 

Section 1881(b)(14) of the Social 

Security Act (the Act) requires a casemix adjusted bundled ESRD PPS for 

renal dialysis services furnished by 

ESRD facilities beginning January 1, 

2011, which replaces the basic case-mix 

adjusted composite payment system. 

Section 1881(b)(14)(E)(i) of the Act 

requires the Secretary to provide a ‘‘fouryear phase-in’’ of the payments under 

the ESRD PPS for renal dialysis services 

furnished on or after January 1, 2011. 

For the purposes of this interim final 

rule with comment, the term 

‘‘transition’’ will be used to describe the 

timeframe during which payments are 

based on the blend of the payment rates 

under the basic case-mix adjusted 

composite payment system and the 

ESRD PPS. Section 1881 (b)(14)(E)(ii) of 

the Act permits an ESRD facility to 

make a one-time election prior to 

January 1, 2011, in a form and manner 

specified by the Secretary of the 

Department of Health and Human 

Services (the Secretary), to be excluded 

from the transition and be paid entirely 

based on the payment amount under the 

ESRD PPS. 

As specified in regulations at 42 CFR 

413.239(b)(1), ESRD facilities were 

required to notify their fiscal 

intermediary or Medicare administrative 

contractor (FI/MAC) of their election 

choice to either be included or excluded 

from the 4-year transition period in a 

manner established by the FI/MAC no 

later than November 1, 2010. In 

addition, § 413.239(b)(1) provides that 

once a decision is made, the election to 

be excluded from the 4-year transition 

cannot be rescinded. As required under 

§ 413.239(b)(3), ESRD facilities that 

became certified for Medicare 

participation and began to furnish 

dialysis services on November 1, 2010 

through December 31, 2010, must have 

notified their FI/MAC of their election 

decision at the time of enrollment. For 

ESRD facilities that failed to make an 

election by November 1, 2010, 

§ 413.239(b)(2) requires that payment be 

based on the blended payment during 

the transition. Further, under 

§ 413.239(c), ESRD facilities that are 

certified for Medicare participation and 

begin furnishing renal or home dialysis 

services on or after January 1, 2011, are 

paid under the ESRD PPS. 

Section 1881(b)(14)(E)(iii) of the Act 

requires that we make an adjustment to 

payments for renal dialysis services 

provided by ESRD facilities during the 

transition so that the estimated total 

amount of payments under the ESRD 

PPS, including payments under the 

transition, equal the estimated total 

amount of payments that would 

otherwise occur under the ESRD PPS 

without a transition. We refer to this 

provision as the transition budgetneutrality adjustment. As described in 

the CY 2011 ESRD PPS final rule (75 FR 


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49082), the transition budget-neutrality 

adjustment is comprised of two parts. 

The first part created a payment 

adjustment under the basic case-mix 

adjusted composite payment system 

portion of the blended rate during the 

transition. The second part created a 

factor that would make the estimated 

total amount of payments under the 

ESRD PPS, including payments under 

the transition, equal the estimated total 

amount of payments that would 

otherwise occur without such a 

transition. In this interim final rule with 

comment, we are addressing the second 

part of the transition budget-neutrality 

adjustment finalized in the CY 2011 

ESRD PPS final rule. 

B. Transition Budget-Neutrality 

Adjustment 

In the CY 2011 ESRD PPS final rule 

(75 FR 49082), we explained that 

section 1881(b)(14)(E)(iii) of the Act 

requires that we make an adjustment to 

payments for renal dialysis services 

furnished by the ESRD facilities during 

the transition so that the estimated total 

amount of payments under the ESRD 

PPS, including payments under the 

transition, equals the estimated total 

amount of payments that would 

otherwise occur under the ESRD PPS 

without such a transition. In calculating 

the transition budget-neutrality 

adjustment, we first determined the 

estimated increases in payments under 

the transition and then determined an 

offset factor, based on certain 

assumptions of which facilities would 

choose to opt out of the transition (74 

FR 49946). We explained that using 

estimates of simulated payments under 

the basic case-mix adjusted composite 

payment and under the ESRD PPS by 

facility, we estimated that 43 percent of 

the 4,951 ESRD facilities would choose 

to be excluded from the transition and 

that 57 percent of those ESRD facilities 

would choose to be paid the blended 

rate during the transition. As a result, 

we estimated that during the first year 

of the transition, total payments would 

exceed the estimated payments under 

the ESRD PPS in the absence of the 

transition (75 FR 49083). 

In order to maintain the 98 percent 

budget-neutrality requirement in section 

1881 (b)(14)(A)(ii) of the Act during the 

initial year of the transition period, we 

finalized the reduction of all payments 

to ESRD facilities in CY 2011 by a factor 

that is equal to 1 minus the ratio of 

estimated payments under the ESRD 

PPS if there were no transition, to the 

total estimated payments under the 

transition, or 3.1 percent. This approach 

resulted in a 3.1 percent reduction in all 

payments to ESRD facilities (that is, the 

3.1 percent adjustment would be 

applied to both the blended payments 

made under the transition and payments 

made 100 percent under the ESRD PPS). 

We stated that we believed that because 

the application of the 3.1 percent 

reduction to all payments would evenly 

distribute the effect of the transition 

adjustment, it would not have affected 

the decision of ESRD facilities when 

choosing whether or not to opt out of 

the transition. 

In the CY 2011 ESRD PPS final rule 

(75 FR 49082 through 49083), we 

acknowledged that the transition 

budget-neutrality adjustment may not 

reflect the actual choices made by the 

ESRD facilities regarding whether or not 

to opt out of the ESRD PPS transition. 

We also indicated that we were not able 

to wait until November 1, 2010, when 

ESRD facilities were to notify their 

respective FI/MACs, to establish the 

transition budget-neutrality adjustment. 

We explained that we based the final 

budget-neutrality adjustment on our 

best projections of how ESRD facilities 

would fare under the ESRD PPS 

compared to the basic case-mix adjusted 

composite payment system. We stated 

that we believed that ESRD facilities 

would choose to be excluded from the 

blended payment if payment under the 

ESRD PPS provided financial benefits. 

We also indicated that the transition 

budget-neutrality adjustment would be 

updated each year of the transition to 

reflect the appropriate blend of the PPS 

and composite rate payments. Finally, 

we noted that given that the transition 

budget-neutrality adjustment applies in 

each transition year, we would consider 

whether we would prospectively correct 

for an over or understatement of the 

number of facilities that chose to opt out 

of the transition when we updated the 

adjustment for CY 2012. 

The simulation (resulting in the 3.1 

percent reduction) was based on 

determining which payment approach 

(that is, blended payments or 100 

percent ESRD PPS payments) would 

financially benefit an ESRD facility. 

However, based upon analysis of the 

elections submitted by ESRD facilities, 

we found that the decision to receive 

payment under the blend or under the 

ESRD PPS did not appear to be based 

solely on which payment approach 

would be more financially 

advantageous. Rather than 43 percent of 

ESRD facilities electing to receive 100 

percent payment under the ESRD PPS as 

was determined by simulating 2007 

payments, 87 percent of ESRD facilities 

elected to opt out of the transition and 

elected to receive full payment under 

the ESRD PPS. We received elections 

from 5,645 ESRD facilities. Of the 5,645 

elections received, 5,068 (or 90 percent) 

opted to receive payment under the 

ESRD PPS. We matched the 5,645 

elections received in 2010 from ESRD 

facilities to the 4,951 facilities in 2007 

that were used in the simulation. Of the 

4,951 facilities, we received 

terminations for three facilities and 

therefore, we removed those three 

facilities from our computation. In 

addition, we did not receive an election 

for 210 facilities. As § 413.239(b)(2) 

requires that payment be made under 

the blend during the transition for 

facilities that fail to make an election by 

November 1, 2010, we considered the 

210 facilities to have elected the 

transition. Therefore, after matching the 

5,645 elections to the 4,951 facilities in 

2007 (including 3 terminations and 210 

assumptions), we determined that 4,324 

of the 4,951 ESRD facilities in 2007 (or 

87 percent) elected to receive payment 

under the ESRD PPS for CY 2011. 

II. Provisions of the Interim Final Rule 

With Comment 

In this interim final rule with 

comment, we are revising the ESRD 

transition budget-neutrality adjustment 

finalized in the CY 2011 ESRD PPS final 

rule (75 FR 49030 through 49214). We 

believe that this updated adjustment 

better reflects the actual elections made 

by ESRD facilities with regard to the 

transition because there is a significant 

difference between the projected and 

the actual number of ESRD facilities that 

elected to receive full payment under 

the ESRD PPS. 

Subsequent to the publication of the 

CY 2011 ESRD PPS final rule, we 

received numerous comments from 

stakeholders including ESRD facilities 

and major ESRD associations requesting 

that we not defer reconciling any 

discrepancies between the estimated 

simulated election decisions with the 

actual decisions made by ESRD 

facilities. These stakeholders cited many 

negative outcomes that would result 

from a 3.1 percent transition budgetneutrality adjustment reduction, 

including limiting or reducing renal 

dialysis services which would result in 

individuals with ESRD experiencing 

difficulties in accessing vital and lifesustaining dialysis services. 

Additionally, these stakeholders cited 

that as a result of the 3.1 percent 

transition budget-neutrality adjustment 

reduction, they would have difficulty 

recruiting and retaining staff, staff to 

patient ratios would decrease, and renal 

dialysis services could be limited. 

We find these requests compelling 

specifically because the number of 

ESRD facilities electing to receive full 

payment under the ESRD PPS is 


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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 18933 

substantially greater than the number of 

facilities that we estimated would elect 

to receive full payment under the ESRD 

PPS and therefore, the assumption used 

in the simulation to calculate the 

transition budget-neutrality adjustment 

was understated. We believe that rather 

than provide for a prospective 

adjustment in CY 2012, it is important 

to revise the transition budget-neutrality 

adjustment at this time for services 

furnished on April 1, 2011 through 

December 31, 2011. 

As discussed in detail below, in this 

interim final rule with comment, we are 

revising the transition budget-neutrality 

adjustment by using the actual number 

of ESRD facilities that elected to receive 

100 percent payment under the ESRD 

PPS. We believe that revising the 

transition budget-neutrality adjustment 

and eliminating the 3.1 percent 

reduction to payments in CY 2011, as 

discussed below, will mitigate 

difficulties cited above in patient access 

to renal dialysis services that could 

result from ESRD facilities limiting 

renal dialysis services due to the 

reduction in payments. 

We are revising the transition budgetneutrality adjustment by re-calculating 

the transition budget-neutrality 

adjustment based on the actual elections 

received by the FI/MACs using the same 

methodology as described in the CY 

2011 ESRD PPS proposed and final 

rules. This results in a zero percent 

adjustment. The zero percent 

adjustment is equal to 1 minus the ratio 

of the estimated payments under the 

ESRD PPS were there no transition (that 

is, 98 percent of total estimated 

payments that would have been made 

under the basic case-mix adjusted 

composite payment) to the total 

estimated payments under the 

transition. 

Therefore, in this interim final rule 

with comment, the revised transition 

budget-neutrality adjustment of zero 

percent will apply prospectively to 

renal dialysis services furnished April 1, 

2011 through December 31, 2011. As 

discussed earlier, we are not changing 

the application of the transition budgetneutrality adjustment factor. We are 

applying the zero percent transition 

budget-neutrality adjustment to both the 

blended payments under the transition 

and payments under the ESRD PPS. 

We note that in the analysis of the 

2010 ESRD facility elections and in our 

computation of the revised transition 

budget-neutrality adjustment using 

actual facility elections that we are 

finalizing in this interim final rule with 

comment, we did not change the 

methodology that was described in the 

CY 2011 ESRD PPS proposed rule (75 

FR 49944 through 49947) published on 

September 29, 2009, and finalized in the 

CY 2011 ESRD PPS final rule (75 FR 

49030 through 49214) for determining 

the revision to the transition budgetneutrality adjustment that will apply to 

renal dialysis services furnished on 

April 1, 2011 through December 31, 

2011; rather, we are merely changing the 

number of ESRD facilities that elected to 

opt out of the transition that was used 

in the transition budget-neutrality 

calculation to reflect the actual rather 

than projected elections. All other 

provisions finalized in the CY 2011 

ESRD PPS final rule remain unchanged. 

III. Waiver of Notice of Proposed 

Rulemaking and the 30-Day Delay in 

the Effective Date 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register in accordance with 5 U.S.C. 

section 553(b) of the Administrative 

Procedure Act (APA) and invite public 

comment on the proposed rule. The 

notice of proposed rulemaking includes 

a reference to the legal authority under 

which the rule is proposed, and the 

terms and substances of the proposed 

rule or a description of the subjects and 

issues involved. This procedure can be 

waived, however, if an agency finds 

good cause that a notice-and-comment 

procedure is impracticable, 

unnecessary, or contrary to the public 

interest and incorporates a statement of 

the finding and its reasons in the rule 

issued. 

In addition, we ordinarily provide a 

30-day delay in the effective date of the 

provisions of an interim final rule with 

comment. Section 553(d) of the APA (5 

U.S.C. section 553(d)) ordinarily 

requires a 30-day delay in the effective 

date of final rules after the date of their 

publication in the Federal Register. 

This 30-day delay in effective date can 

be waived, however, if an agency finds 

for good cause that the delay is 

impracticable, unnecessary, or contrary 

to the public interest, and the agency 

incorporates a statement of the finding 

and its reasons in the rule issued. In 

addition, similar notice-and-comment 

procedures and a 30-day delay in 

effective date are required, but can be 

waived under section 1871 of the Act. 

We find good cause that it is 

unnecessary to undertake notice-andcomment rulemaking to revise the ESRD 

transition budget-neutrality adjustment 

by updating estimated figures with 

actual figures, because we are not 

changing our underlying methodology 

for computing or applying the transition 

budget-neutrality adjustment. The 

numbers we are updating pertain to 

elections made by ESRD facilities with 

regard to participation in the transition. 

Because we are not attempting to further 

project how ESRD facilities would 

behave and are instead using the actual 

number of the facilities that opted out 

of the transition, we find notice and the 

opportunity for public comment 

unnecessary. 

In addition, we also find good cause 

to waive these procedures with regard to 

revising the transition budget-neutrality 

adjustment because it would be contrary 

to the public interest to maintain the 

adjustment finalized in the CY 2011 

ESRD PPS final rule for the remainder 

of CY 2011. In particular, we believe 

that delaying the revision of the 

transition budget-neutrality adjustment 

until the CY 2012 rulemaking in order 

to allow ESRD facilities an opportunity 

to comment on the revised adjustment 

that converts a 3.1 percent payment 

reduction to zero percent payment 

adjustment, could further decrease renal 

dialysis services to a vulnerable 

population that relies on these services 

to maintain their lives. For example, 

stakeholders have informed us that as a 

result of the 3.1 percent transition 

budget-neutrality adjustment reduction 

based on CMS’ estimation of the ESRD 

facilities that would elect to receive full 

payment under the ESRD PPS, they will 

have difficulty recruiting and retaining 

staff, staff to patient ratios could 

decrease, and services could decrease 

due to decreases in staff and supplies. 

Therefore, we believe that delaying this 

revision could result in difficulties in 

access of care. We believe that revising 

the transition budget-neutrality 

adjustment in the way we discussed 

above and applying it without delay 

will mitigate these concerns and 

difficulties, and therefore, we find good 

cause to waive notice and comment 

rulemaking. 

Also, for the reasons above, we 

believe that it is unnecessary and it is 

contrary to the public interest to delay 

the application of the revised transition 

budget-neutrality adjustment factor in 

order to provide for the required 30-day 

delay in the effective date of this interim 

final rule with comment. Delaying the 

effective date for an additional 30 days 

would further delay revising the 

adjustment (and therefore, the 

underestimation of how ESRD facilities 

would elect to receive payment under 

the ESRD PPS) and would continue to 

place a financial burden on ESRD 

facilities. 

Therefore, for the reasons stated 

above, we believe there is good cause to 

waive not only notice-and-comment 

procedures but also the 30-day delay in 

the effective date for this interim final 

rule with comment. 


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18934 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 

IV. Collection of Information 

Requirements 

This interim final rule with comment 

does not impose information collection 

and recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

VI. Regulatory Impact Statement 

We have examined the impact of this 

interim final rule with comment period 

as required by Executive Order 12866 

on Regulatory Planning and Review 

(September 30, 1993), Executive Order 

13563 on Improving Regulation and 

Regulatory Review (January 18, 2011), 

the Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, section 202 of the Unfunded 

Mandates Reform Act of 1995 (March 

22, 1995; Pub. L. 104–4), Executive 

Order 13132 on Federalism (August 4, 

1999) and the Congressional Review Act 

(5 U.S.C. 804(2)). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. A 

regulatory impact analysis (RIA) must 

be prepared for major rules with 

economically significant effects ($100 

million or more in any 1 year). This is 

not a significant rule and we have 

determined that this interim final rule 

with comment does not have a 

significant economic impact. Therefore, 

we have not prepared an RIA. 

With regards to the ESRD transition 

budget-neutrality adjustment, we 

believe that with a zero percent 

adjustment we are budget-neutral for 

payments made for renal dialysis 

services furnished on April 1, 2011 

through December 31, 2011. The zero 

percent transition budget-neutrality 

adjustment applied to payments made 

to ESRD facilities for renal dialysis 

services furnished on April 1, 2011 

through December 31, 2011 will 

increase payments to providers as 

compared to payments they would 

receive with a 3.1 percent transition 

budget-neutrality adjustment reduction. 

This will benefit all providers. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities, if a rule has a significant impact 

on a substantial number of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $7.0 million to $34.5 million in any 

1 year. Individuals and States are not 

included in the definition of a small 

entity. All ESRD facilities will receive a 

zero percent budget-neutrality 

adjustment to their payment for renal 

dialysis services furnished April 1, 2011 

through December 31, 2011, instead of 

a 3.1 percent reduction, including small 

dialysis facilities. We are not preparing 

an analysis for the RFA because the 

Secretary has determined that this 

interim final rule with comment will 

not have a significant economic impact 

on a substantial number of small 

entities. 

In addition, section 1102(b) of the 

Social Security Act (the Act) requires us 

to prepare a regulatory impact analysis 

if a rule may have a significant impact 

on the operations of a substantial 

number of small rural hospitals. This 

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 for Medicare payment 

regulations and has fewer than 100 

beds. We are not preparing an analysis 

for section 1102(b) of the Act because 

the Secretary has determined this rule 

does not have a substantial impact on 

small rural hospitals. Most dialysis 

facilities are free standing and we have 

determined that that this interim final 

rule with comment will not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2011, that threshold is approximately 

$136 million. This rule will have no 

consequential effect on State, local, or 

Tribal governments or on the private 

sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

Since this regulation does not impose 

any costs on State or local governments, 

the requirements of Executive Order 

13132 are not applicable. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services are revising the 3.1 

percent transition budget-neutrality 

adjustment reduction to a zero percent 

transition budget-neutrality adjustment 

for renal dialysis services furnished on 

April 1, 2011 through December 31, 

2011. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 18, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: March 29, 2011. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2011–8181 Filed 4–1–11; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2011–0002; Internal 

Agency Docket No. FEMA–8175] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities, where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP), that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 


erowe on DSK5CLS3C1PROD with RULES