[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Rules and Regulations]
[Pages 81767-81769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32967]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 413

[CMS-1628-CN2]
RIN 0938-AS48


Medicare Program; End-Stage Renal Disease Prospective Payment 
System, and Quality Incentive Program; Correction

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

ACTION: Final rule, correction.

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SUMMARY: This document corrects technical and typographical errors that 
appeared in the final rule published in the Federal Register on 
November 6, 2015, entitled ``Medicare Program; End-Stage Renal Disease 
Prospective Payment System, and Quality Incentive Program.''

DATES: This correction is effective on December 31, 2015.

FOR FURTHER INFORMATION CONTACT: CMS ESRD Payment mailbox at 
[email protected], for issues related to the ESRD PPS payment 
provisions. Heidi Oumarou, (410) 786-7942, for issues related to the 
ESRD market basket. Tamyra Garcia, (410) 786-0856, for issues related 
to the ESRD QIP.

SUPPLEMENTARY INFORMATION: 

I. Background

    In FR Doc. 2015-27928 of November 6, 2015 (80 FR 68967) 
(hereinafter referred to as the CY 2016 ESRD PPS final rule) there are 
technical and typographical errors that are discussed in the ``Summary 
of Errors,'' and further identified and corrected in the ``Correction 
of Errors'' section below. The provisions in this correction notice are 
effective as if they had been included in the CY 2016 ESRD PPS final 
rule published in the Federal Register on November 6, 2015.

II. Summary of Errors

    On page 68968, in the FOR FURTHER INFORMATION CONTACT section we 
found

[[Page 81768]]

an error in the email address provided to contact us for ESRD PPS 
payment issues. The correct email address is [email protected]. 
In addition, the telephone number provided for questions related to the 
ESRD market basket was incorrect for Heidi Oumarou. The correct 
telephone number is 410-786-7942.
    On page 68976, we made a typographic error by including the words 
``case-mix'' in the beginning of sentence.'' On page 68986, under the 
heading ``Body Surface Area (BSA)'', we made a typographical error in 
the value 1.020. We inadvertently inserted the letter ``I'' instead of 
the number ``1'' in that value.
    On page 69044, we made a technical error in the title of Table 17--
``Estimated Numerical Values for the Performance Standards for the PY 
2018 ESRD QIP Clinical Measures Using the Most Recently Available 
Data,'' by indicating that the values were estimates instead of 
finalized numerical values. In addition, there were errors in the 
achievement threshold, benchmark, and performance standard values 
presented in Table 17 ``for Payment Year 2018 of the End-Stage Renal 
Disease Quality Incentive Program. Specifically, the numerical values 
published for the Kt/V Adult Hemodialysis, Kt/V Pediatric Hemodialysis, 
Standardized Readmission Ratio clinical measures, and ICH CAHPS were 
incorrect because we inadvertently placed the numbers in the incorrect 
columns.
    On page 69069, in footnote 15 regarding the responsibilities of 
various staff, we found an error in the hyperlink to a document posted 
by the Bureau of Labor & Statistics.
    Finally, on page 69073, after ``e. Alternatives Considered,'' we 
inadvertenly did not include the subtitle ``1. CY 2016 End-Stage Renal 
Disease'' to delineate the analysis of alternatives policies considered 
for the ESRD PPS.

III. Waiver of Proposed Rulemaking, 60-Day Comment Period, and Delay of 
Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rule in the 
Federal Register before the provisions of a rule take effect. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide notice of the proposed rule in the Federal Register and provide 
a period of not less than 60 days for public comment. In addition, 
section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act 
mandate a 30-day delay in effective date after issuance or publication 
of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for 
exceptions from the notice and comment and delay in effective date. APA 
requirements; in cases in which these exceptions apply, sections 
1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from 
the notice and 60-day comment period and delay in effective date 
requirements as well. Section 553(b)(B) of the APA and section 
1871(b)(2)(C) of the Act authorize an agency to dispense with normal 
rulemaking requirements for good cause if the agency makes a finding 
that the notice and comment process are impracticable, unnecessary, or 
contrary to the public interest. In addition, both section 553(d)(3) of 
the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to 
avoid the 30-day delay in effective date where such delay is contrary 
to the public interest and an agency includes a statement of support.
    In our view, this correcting document does not constitute 
rulemaking that would be subject to these requirements. This correcting 
document is simply correcting technical and typographical errors in the 
preamble and does not make substantive changes to the policies or 
payment methodologies that were adopted in the final rule, and 
therefore, it is unnecessary to follow the notice and comment procedure 
in this instance.
    Even if this were a rulemaking to which the notice and comment and 
delayed effective date requirements applied, we find that there is good 
cause to waive such requirements. Undertaking further notice and 
comment procedures to incorporate the corrections in this document into 
the CY 2016 ESRD PPS final rule or delaying the effective date would be 
contrary to the public interest because it is in the public's interest 
for dialysis facilities to receive appropriate payments in as timely a 
manner as possible, and to ensure that the CY 2016 ESRD PPS final rule 
accurately reflects our policies as of the date they take effect and 
are applicable. Further, such procedures would be unnecessary, because 
we are not altering the payment methodologies or policies, but rather, 
we are simply correctly implementing the policies that we previously 
proposed, received comment on, and subsequently finalized. This 
correcting document is intended solely to ensure that the CY 2016 ESRD 
PPS final rule accurately reflects these payment methodologies and 
policies. For these reasons, we believe we have good cause to waive the 
notice and comment and effective date requirements.

IV. Correction of Errors

    In FR Doc. 2015-27928 of November 6, 2015 (80 FR 68968), make the 
following corrections:
    1. On page 68968, first column, under section FOR FURTHER 
INFORMATION CONTACT:--
    a. In line 1, the email address ``CMS ESRD [email protected]'' is 
corrected to read ``ESRD[email protected]''.
    b. In lines 3 and 4, the telephone number ``410-786-7342'' is 
corrected to read ``410-786-7942''.
    2. On page 68976, first column, first full paragraph, line 21, 
remove the word ``case-mix''.
    3. On page 68986, second column, first paragraph under the heading 
``Body Surface Area (BSA),'' line 5, the figure ``l.020'' is corrected 
to read ``1.020''.
    4. On page 69044, Table 17 is corrected to read as follows:

 Table 17--Final Numerical Values for the Performance Standards for the PY 2018 ESRD QIP Clinical Measures Using
                                        the Most Recently Available Data
----------------------------------------------------------------------------------------------------------------
               Measure                  Achievement threshold          Benchmark           Performance standard
----------------------------------------------------------------------------------------------------------------
Vascular Access Type:
    %Fistula.........................  53.51%.................  79.60%.................  65.94%.
    %Catheter........................  16.79%.................  2.59%..................  8.80%.
Kt/V:
    Adult Hemodialysis...............  92.88%.................  99.43%.................  97.24%.
    Adult Peritoneal Dialysis........  75.42%.................  97.06%.................  89.47%.
    Pediatric Hemodialysis...........  81.25%.................  96.88%.................  93.94%.

[[Page 81769]]

 
    Pediatric Peritoneal Dialysis....  43.22%.................  88.39%.................  72.60%.
Hypercalcemia........................  3.92%..................  0.00%..................  1.19%.
NHSN Bloodstream Infection SIR.......  1.812..................  0......................  0.861.
Standardized Readmission Ratio.......  1.297..................  0.588..................  0.998.
Standardized Transfusion Ratio.......  1.470..................  0.431..................  0.923.
ICH CAHPS............................  15th percentile of       90th percentile of       50th percentile of
                                        eligible facilities'     eligible facilities'     eligible facilities'
                                        performance during CY    performance during CY    performance during CY
                                        2015.                    2015.                    2015.
----------------------------------------------------------------------------------------------------------------

    11. On page 69069, third column, bottom of the page, footnote 15, 
the reference to ``http://www.bls/gov/ooh/healthcare/medical-records-and-health-information-technicians.htm'' is corrected to read ``http://www.bls.gov/ooh/healthcare/medical-records-and-health-information-technicians.htm''.
    12. On page 69073, second column under the heading ``e. 
Alternatives Considered'' add the sub-heading ``1. CY 2016 End-Stage 
Renal Disease''.

    Dated: December 28, 2015.
Madhura Valverde,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2015-32967 Filed 12-30-15; 8:45 am]
 BILLING CODE 4120-01-P