Medicare Programs: Changes to the End-Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment, 18930-18934 [2011-8181]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Rules and Regulations]
[Pages 18930-18934]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8181]


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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 Budget-Neutrality Adjustment

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment will revise the end-stage 
renal disease (ESRD) transition budget-neutrality 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

[[Page 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 https://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: https://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 
case-mix 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 
``four-year 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, Sec.  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 Sec.  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, Sec.  413.239(b)(2) requires that payment be based on 
the blended payment during the transition. Further, under Sec.  
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 budget-neutrality adjustment. As described in the CY 
2011 ESRD PPS final rule (75 FR

[[Page 18932]]

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 Sec.  
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 budget-neutrality adjustment reduction, including 
limiting or reducing renal dialysis services which would result in 
individuals with ESRD experiencing difficulties in accessing vital and 
life-sustaining 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

[[Page 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 budget-neutrality 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 budget-neutrality 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 budget-neutrality 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-and-
comment 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.

[[Page 18934]]

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]
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