[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Rules and Regulations]
[Pages 94268-94270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31019]



[[Page 94268]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 413, 414 and 494

[CMS-1651-CN]


Medicare Program; End-Stage Renal Disease Quality Incentive 
Program; Durable Medical Equipment, Prosthetics, Orthotics, and 
Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure, 
and Appeals Process for Breach of Contract Actions; 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 4, 2016, entitled ``Medicare Program; End-Stage Renal Disease 
Prospective Payment System, Coverage and Payment for Renal Dialysis 
Services Furnished to Individuals with Acute Kidney Injury, End-Stage 
Renal Disease Quality Incentive Program, Durable Medical Equipment, 
Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid 
Surety Bonds, State Licensure and Appeals Process for Breach of 
Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and 
Supplies Competitive Bidding Program and Fee Schedule Adjustments, 
Access to Care Issues for Durable Medical Equipment; and the 
Comprehensive End-Stage Renal Disease Care Model.''

DATES: This correction is effective on January 1, 2017.

FOR FURTHER INFORMATION CONTACT: Julia Howard, (410) 786-8645, for 
issues related to DMEPOS CBP and bid surety bonds, state licensure, and 
the appeals process for breach of DMEPOS CBP contract actions. 
Stephanie Frilling, (410) 786-4507, for issues related to the ESRD QIP.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2016-26152 of November 4, 2016 (81 FR 77834) 
(hereinafter referred to as the CY 2017 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 2017 ESRD PPS final 
rule published in the Federal Register on November 4, 2016.

II. Summary of Errors

    On page 77874, we inadvertently made technical errors with respect 
to the calculation of the performance standard values in Table 2, 
``Improvement of Performance Standards Over Time.''
    On page 77886, we inadvertently made technical errors with respect 
to the calculation based on the most recently available data of the 
Achievement Threshold and Performance Standard values that apply to the 
Kt/V Composite, Standardized Transfusion Ratio and Hypercalcemia 
measures, and the calculation based on the most recently available data 
of the Achievement Threshold, Benchmark and Performance Standard values 
that apply to the ICH CAHPS measure in Table 6, ``Finalized Numerical 
Values for the Performance Standards for the PY 2019 ESRD QIP Clinical 
Measures Using the Most Recently Available Data.'' We also 
inadvertently included values for the Achievement Threshold, Benchmark 
and Performance Standard for the Standardized Hospitalization Ratio 
Clinical Measure, which is not a measure that we have adopted for the 
PY 2019 program.
    On page 77897, we inadvertently included values for the 
Standardized Hospitalization Ratio Clinical Measure, which is not a 
finalized PY 2019 ESRD QIP measure, in Table 12, ``PY 2020 Clinical 
Measure Including Facilities With at Least 11 Eligible Patients Per 
Measure.''
    On page 77932 we made a technical error in our response to the 
first comment under ``1. Bid Surety Bond Requirement''. In our 
response, we stated ``While we acknowledge that there will be a number 
of entities that are required to make large expenditures in order to 
obtain a bid surety bond for each CBA in which they are submitting a 
bid, we anticipate that this revision on the bid surety bond amount 
from $100,000 to $50,000 will reduce that overall burden on all 
suppliers.'' We inadvertently included the term ``suppliers'' at the 
end of the sentence but the term should read ``bidders.''
    On page 77933 in our response to the comment on why the bid surety 
bond was only required until January 1, 2019, we inadvertently included 
a ``1'' in the reference to the round of competition in 2019 in which 
the bid surety bond requirement commences. The reference should read 
``Round 2019'' and not ``Round 1 2019.''
    At the top of page 77934 in our discussion on ``Appeals Process for 
a DMEPOS Competitive Bidding Breach of Contract Action'' we repeated a 
typographical error from the proposed rule (81 FR 42849) by stating 
that we proposed removing ``Sec.  414.423(g)(2)(i)'' from the 
regulation. The correct citation in this discussion should read ``Sec.  
414.422(g)(2)(i)'', consistent with the proposal to remove corrective 
action plan from the list of actions for a breach of contract in the 
regulation, as described in the preamble and regulation text of the 
proposed and final rules (81 FR 42849, 42878, and 81 FR 77934, 77967).

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 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.

[[Page 94269]]

    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 2017 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 2017 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. 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. 2016-26152 of November 4, 2016 (81 FR 77834), we make 
the following corrections:
    1. On page 77874, Table 2 is corrected to read as follows:

                             Table 2--Improvement of Performance Standards Over Time
----------------------------------------------------------------------------------------------------------------
             Measure                  PY 2015         PY 2016         PY 2017         PY 2018         PY 2019
----------------------------------------------------------------------------------------------------------------
Hemoglobin >12 g/dL.............              1%              0%  ..............  ..............  ..............
Vascular Access Type:
    % Fistula...................             60%           62.3%          64.46%          65.94%          65.93%
    % Catheter..................             13%           10.6%           9.92%           8.80%           9.19%
Kt/V:
    Adult Hemodialysis..........             93%           93.4%          96.89%          97.24%  ..............
    Adult Peritoneal Dialysis...             84%           85.7%          87.10%          89.47%  ..............
    Pediatric Hemodialysis......             93%             93%          94.44%          93.94%  ..............
    Pediatric Peritoneal          ..............  ..............  ..............          72.60%  ..............
     Dialysis...................
Hypercalcemia...................  ..............           1.70%           1.30%           1.19%           1.85%
NHSN Bloodstream Infection SIR..  ..............  ..............  ..............           0.861           0.797
Standardized Readmission Ratio..  ..............  ..............           0.998           0.998           0.998
Standardized Transfusion Ratio..  ..............  ..............  ..............           0.923           0.894
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    2. On page 77886, Table 6 is corrected to read as follows:

  Table 6--Finalized Numerical Values for the Performance Standards for the PY 2019 ESRD QIP Clinical Measures
                                     Using the Most Recently Available Data
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                                                            Achievement                           Performance
                        Measure                              threshold          Benchmark           standard
----------------------------------------------------------------------------------------------------------------
Vascular Access Type:
    %Fistula...........................................             53.66%             79.62%             65.93%
    %Catheter..........................................             17.20%              2.95%              9.19%
Kt/V Composite.........................................             86.99%             97.74%             93.08%
Hypercalcemia..........................................              4.24%              0.32%              1.85%
Standardized Transfusion Ratio.........................              1.488              0.421              0.901
Standardized Readmission Ratio.........................              1.289              0.624              0.998
NHSN Bloodstream Infection.............................              1.738                  0              0.797
ICH CAHPS: Nephrologists' Communication and Caring.....             56.41%             77.06%             65.89%
ICH CAHPS: Quality of Dialysis Center Care and                      52.88%             71.21%             60.75%
 Operations............................................
ICH CAHPS: Providing Information to Patients...........             72.09%             85.55%             78.59%
ICH CAHPS: Overall Rating of Nephrologists.............             49.33%             76.57%             62.22%
ICH CAHPS: Overall Rating of Dialysis Center Staff.....             48.84%             77.42%             62.26%
ICH CAHPS: Overall Rating of the Dialysis Facility.....             51.18%             80.58%             65.13%
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Data Sources: VAT measures: 2015 Medicare claims; SRR, STrR: 2015 Medicare claims; Kt/V: 2015 Medicare claims
  and 2015 CROWNWEB; Hypercalcemia: 2015 CROWNWeb; NHSN: CDC; CAHPS: 2015 ICH CAHPS surveys.


[[Page 94270]]

    3. On page 77897, Table 12 is corrected to read as follows:

                         Table 12--PY 2020 Clinical Measures Including Facilities With at Least 11 Eligible Patients per Measure
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                                                                                   Statistically
            Measure                   N       75th/25th   90th/10th   Std error      Indistin-       Truncated    Truncated      TCV        TCV's 0.10
                                             Percentile  Percentile                  guishable         mean          SD
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Kt/V Delivered Dose above              6210        96.0        98.0       0.093  No..............        92.5          4.20        0.05  Yes.
 minimum.
Fistula Use....................        5906        73.2        79.6       0.148  No..............        65.7          8.88        0.14  No.
Catheter Use...................        5921        5.43        2.89       0.093  No..............    \1\ 90.1          5.16       <0.01  Yes.
Serum Calcium >10.2............        6257        0.91        0.32       0.049  No..............    \1\ 97.8          1.48       <0.01  Yes.
NHSN--SIR......................        5781        0.41        0.00       0.011  No..............         0.963        0.57       <0.01  Yes.
SRR............................        5739        0.82        0.64       0.004  No..............         0.995        0.21       <0.01  Yes.
STrR...........................        5650        0.64        0.43       0.008  No..............         0.965        0.37       <0.01  Yes.
ICH CAHPS:
Nephrologists communication and        3349        71.8        77.1       0.159  No..............        65.7          7.11        0.11  No.
 caring.
Quality of dialysis center care        3349        66.2        71.2       0.134  No..............        60.9          6.20        0.10  No.
 and operations.
Providing information to               3349        82.4        85.6       0.101  No..............        78.4          4.61        0.06  Yes.
 patients.
Rating of Nephrologist.........        3349        69.9        76.6       0.204  No..............        62.0          9.29        0.15  No.
Rating of dialysis facility            3349        70.9        77.4       0.215  No..............        62.0          9.92        0.16  No.
 staff.
Rating of dialysis center......        3349        73.8        80.6       0.221  No..............        64.8         10.18        0.16  No.
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\1\ Truncated mean for percentage is reversed (100 percent-truncated mean) for measures where lower score = better performance.

    4. On page 77932, third column, line 17, the word ``suppliers'' is 
corrected to read as ``bidders''.
    5. On page 77933, first column, line 30, remove the number ``1'' 
before ``2019''.
    6. On page 77934, first column, line 3, the citation ``Sec.  
414.423(g)(2)(i)'' is corrected to read ``Sec.  414.422(g)(2)(i)''.

    Dated: December 19, 2016.
Madhura Valverde,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2016-31019 Filed 12-22-16; 8:45 am]
BILLING CODE 4120-01-P