81_FR_94515 81 FR 94268 - 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

81 FR 94268 - 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

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

Federal Register Volume 81, Issue 247 (December 23, 2016)

Page Range94268-94270
FR Document2016-31019

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.''

Federal Register, Volume 81 Issue 247 (Friday, December 23, 2016)
[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Rules and Regulations]
[Pages 94268-94270]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------
                                                            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%
----------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Statistically
            Measure                   N       75th/25th   90th/10th   Std error      Indistin-       Truncated    Truncated      TCV        TCV's 0.10
                                             Percentile  Percentile                  guishable         mean          SD
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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



                                                94268            Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Rules and Regulations

                                                DEPARTMENT OF HEALTH AND                                rule published in the Federal Register                DMEPOS Competitive Bidding Breach
                                                HUMAN SERVICES                                          on November 4, 2016.                                  of Contract Action’’ we repeated a
                                                                                                                                                              typographical error from the proposed
                                                Centers for Medicare & Medicaid                         II. Summary of Errors
                                                                                                                                                              rule (81 FR 42849) by stating that we
                                                Services                                                   On page 77874, we inadvertently                    proposed removing ‘‘§ 414.423(g)(2)(i)’’
                                                                                                        made technical errors with respect to                 from the regulation. The correct citation
                                                42 CFR Parts 413, 414 and 494                           the calculation of the performance                    in this discussion should read
                                                                                                        standard values in Table 2,                           ‘‘§ 414.422(g)(2)(i)’’, consistent with the
                                                [CMS–1651–CN]                                           ‘‘Improvement of Performance                          proposal to remove corrective action
                                                Medicare Program; End-Stage Renal                       Standards Over Time.’’                                plan from the list of actions for a breach
                                                                                                           On page 77886, we inadvertently                    of contract in the regulation, as
                                                Disease Quality Incentive Program;
                                                                                                        made technical errors with respect to                 described in the preamble and
                                                Durable Medical Equipment,
                                                                                                        the calculation based on the most                     regulation text of the proposed and final
                                                Prosthetics, Orthotics, and Supplies
                                                                                                        recently available data of the                        rules (81 FR 42849, 42878, and 81 FR
                                                Competitive Bidding Program Bid                         Achievement Threshold and
                                                Surety Bonds, State Licensure, and                                                                            77934, 77967).
                                                                                                        Performance Standard values that apply
                                                Appeals Process for Breach of                           to the Kt/V Composite, Standardized                   III. Waiver of Proposed Rulemaking,
                                                Contract Actions; Correction                            Transfusion Ratio and Hypercalcemia                   60-Day Comment Period, and Delay of
                                                                                                        measures, and the calculation based on                Effective Date
                                                AGENCY:  Centers for Medicare &
                                                Medicaid Services (CMS), HHS.                           the most recently available data of the                  Under 5 U.S.C. 553(b) of the
                                                ACTION: Final rule; correction.
                                                                                                        Achievement Threshold, Benchmark                      Administrative Procedure Act (APA),
                                                                                                        and Performance Standard values that                  the agency is required to publish a
                                                SUMMARY:   This document corrects                       apply to the ICH CAHPS measure in                     notice of the proposed rule in the
                                                technical and typographical errors that                 Table 6, ‘‘Finalized Numerical Values                 Federal Register before the provisions
                                                appeared in the final rule published in                 for the Performance Standards for the                 of a rule take effect. Similarly, section
                                                the Federal Register on November 4,                     PY 2019 ESRD QIP Clinical Measures                    1871(b)(1) of the Act requires the
                                                2016, entitled ‘‘Medicare Program; End-                 Using the Most Recently Available                     Secretary to provide notice of the
                                                Stage Renal Disease Prospective                         Data.’’ We also inadvertently included                proposed rule in the Federal Register
                                                Payment System, Coverage and Payment                    values for the Achievement Threshold,                 and provide a period of not less than 60
                                                for Renal Dialysis Services Furnished to                Benchmark and Performance Standard                    days for public comment. In addition,
                                                Individuals with Acute Kidney Injury,                   for the Standardized Hospitalization                  section 553(d) of the APA, and section
                                                End-Stage Renal Disease Quality                         Ratio Clinical Measure, which is not a                1871(e)(1)(B)(i) of the Act mandate a 30-
                                                Incentive Program, Durable Medical                      measure that we have adopted for the                  day delay in effective date after issuance
                                                Equipment, Prosthetics, Orthotics and                   PY 2019 program.                                      or publication of a rule. Sections
                                                Supplies Competitive Bidding Program                       On page 77897, we inadvertently                    553(b)(B) and 553(d)(3) of the APA
                                                Bid Surety Bonds, State Licensure and                   included values for the Standardized                  provide for exceptions from the notice
                                                Appeals Process for Breach of Contract                  Hospitalization Ratio Clinical Measure,               and comment and delay in effective
                                                Actions, Durable Medical Equipment,                     which is not a finalized PY 2019 ESRD                 date. APA requirements; in cases in
                                                Prosthetics, Orthotics and Supplies                     QIP measure, in Table 12, ‘‘PY 2020                   which these exceptions apply, sections
                                                Competitive Bidding Program and Fee                     Clinical Measure Including Facilities                 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
                                                Schedule Adjustments, Access to Care                    With at Least 11 Eligible Patients Per                Act provide exceptions from the notice
                                                Issues for Durable Medical Equipment;                   Measure.’’                                            and 60-day comment period and delay
                                                and the Comprehensive End-Stage Renal                      On page 77932 we made a technical                  in effective date requirements as well.
                                                Disease Care Model.’’                                   error in our response to the first                    Section 553(b)(B) of the APA and
                                                                                                        comment under ‘‘1. Bid Surety Bond                    section 1871(b)(2)(C) of the Act
                                                DATES: This correction is effective on
                                                                                                        Requirement’’. In our response, we                    authorize an agency to dispense with
                                                January 1, 2017.
                                                                                                        stated ‘‘While we acknowledge that                    normal rulemaking requirements for
                                                FOR FURTHER INFORMATION CONTACT: Julia                  there will be a number of entities that               good cause if the agency makes a
                                                Howard, (410) 786–8645, for issues                      are required to make large expenditures               finding that the notice and comment
                                                related to DMEPOS CBP and bid surety                    in order to obtain a bid surety bond for              process are impracticable, unnecessary,
                                                bonds, state licensure, and the appeals                 each CBA in which they are submitting                 or contrary to the public interest. In
                                                process for breach of DMEPOS CBP                        a bid, we anticipate that this revision on            addition, both section 553(d)(3) of the
                                                contract actions. Stephanie Frilling,                   the bid surety bond amount from                       APA and section 1871(e)(1)(B)(ii) of the
                                                (410) 786–4507, for issues related to the               $100,000 to $50,000 will reduce that                  Act allow the agency to avoid the 30-
                                                ESRD QIP.                                               overall burden on all suppliers.’’ We                 day delay in effective date where such
                                                SUPPLEMENTARY INFORMATION:                              inadvertently included the term                       delay is contrary to the public interest
                                                                                                        ‘‘suppliers’’ at the end of the sentence              and an agency includes a statement of
                                                I. Background
                                                                                                        but the term should read ‘‘bidders.’’                 support.
                                                   In FR Doc. 2016–26152 of November                       On page 77933 in our response to the                  In our view, this correcting document
                                                4, 2016 (81 FR 77834) (hereinafter                      comment on why the bid surety bond                    does not constitute rulemaking that
                                                referred to as the CY 2017 ESRD PPS                     was only required until January 1, 2019,              would be subject to these requirements.
                                                final rule) there are technical and                     we inadvertently included a ‘‘1’’ in the              This correcting document is simply
jstallworth on DSK7TPTVN1PROD with RULES




                                                typographical errors that are discussed                 reference to the round of competition in              correcting technical errors in the
                                                in the ‘‘Summary of Errors,’’ and further               2019 in which the bid surety bond                     preamble and does not make substantive
                                                identified and corrected in the                         requirement commences. The reference                  changes to the policies or payment
                                                ‘‘Correction of Errors’’ section below.                 should read ‘‘Round 2019’’ and not                    methodologies that were adopted in the
                                                The provisions in this correction notice                ‘‘Round 1 2019.’’                                     final rule, and therefore, it is
                                                are effective as if they had been                          At the top of page 77934 in our                    unnecessary to follow the notice and
                                                included in the CY 2017 ESRD PPS final                  discussion on ‘‘Appeals Process for a                 comment procedure in this instance.


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                                                                       Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Rules and Regulations                                                                                                   94269

                                                  Even if this were a rulemaking to                                      is in the public’s interest for dialysis                                    to waive the notice and comment and
                                                which the notice and comment and                                         facilities to receive appropriate                                           effective date requirements.
                                                delayed effective date requirements                                      payments in as timely a manner as
                                                applied, we find that there is good cause                                possible, and to ensure that the CY 2017                                    IV. Correction of Errors
                                                to waive such requirements.                                              ESRD PPS final rule accurately reflects                                        In FR Doc. 2016–26152 of November
                                                Undertaking further notice and                                           our policies as of the date they take
                                                                                                                                                                                                     4, 2016 (81 FR 77834), we make the
                                                comment procedures to incorporate the                                    effect and are applicable. Further, such
                                                                                                                                                                                                     following corrections:
                                                corrections in this document into the                                    procedures would be unnecessary,
                                                CY 2017 ESRD PPS final rule or                                           because we are not altering the payment                                       1. On page 77874, Table 2 is corrected
                                                delaying the effective date would be                                     methodologies or policies. For these                                        to read as follows:
                                                contrary to the public interest because it                               reasons, we believe we have good cause

                                                                                               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 Dialysis .........................................                ........................   ........................   ........................              72.60%          ........................
                                                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



                                                  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
                                                                                                                                                                                    Achievement                                                        Performance
                                                                                                      Measure                                                                                                         Benchmark
                                                                                                                                                                                     threshold                                                          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 Operations .................................                                                      52.88%                          71.21%                           60.75%
                                                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%
                                                  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.
jstallworth on DSK7TPTVN1PROD with RULES




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                                                94270                     Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Rules and Regulations

                                                  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
                                                                                                                                                                    Statistically
                                                                                                                         75th/25th     90th/10th                                         Truncated     Truncated
                                                                      Measure                                   N                                      Std error      Indistin-                                      TCV       TCV’s 0.10
                                                                                                                         Percentile    Percentile                                          mean           SD
                                                                                                                                                                     guishable

                                                Kt/V Delivered Dose above minimum ..                             6210           96.0         98.0          0.093    No   .............        92.5          4.20        0.05   Yes.
                                                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 car-                             3349           71.8         77.1          0.159    No .............         65.7           7.11        0.11   No.
                                                  ing.
                                                Quality of dialysis center care and op-                          3349           66.2         71.2          0.134    No .............         60.9           6.20        0.10   No.
                                                  erations.
                                                Providing information to patients .........                      3349           82.4         85.6          0.101    No   .............       78.4           4.61        0.06   Yes.
                                                Rating of Nephrologist .........................                 3349           69.9         76.6          0.204    No   .............       62.0           9.29        0.15   No.
                                                Rating of dialysis facility staff ...............                3349           70.9         77.4          0.215    No   .............       62.0           9.92        0.16   No.
                                                Rating of dialysis center .......................                3349           73.8         80.6          0.221    No   .............       64.8          10.18        0.16   No.
                                                   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                                   Avenue SE., Washington, DC 20590                               maintenance-of-way (MOW) employees
                                                17, the word ‘‘suppliers’’ is corrected to                                (telephone 202–493–6313); or Sam Noe,                          (81 FR 37894). MOW employees will
                                                read as ‘‘bidders’’.                                                      FRA Drug and Alcohol Program                                   become subject to FRA random drug
                                                   5. On page 77933, first column, line                                   Specialist (telephone 615–719–2951).                           and alcohol testing on June 12, 2017,
                                                30, remove the number ‘‘1’’ before                                        SUPPLEMENTARY INFORMATION: For the                             when the final rule takes effect. In 1994,
                                                ‘‘2019’’.                                                                 next calendar year, FRA determines the                         when FRA, in concert with the other
                                                   6. On page 77934, first column, line                                   minimum annual random drug testing                             DOT modes, established a drug MIS
                                                3, the citation ‘‘§ 414.423(g)(2)(i)’’ is                                 rate and the minimum annual random                             system (58 FR 68232, December 23,
                                                corrected to read ‘‘§ 414.422(g)(2)(i)’’.                                 alcohol testing rate for railroad                              1993), FRA set its initial minimum
                                                  Dated: December 19, 2016.                                               employees covered by hours of service                          random drug testing rate at 50 percent
                                                Madhura Valverde,                                                         laws and regulations (covered service                          for covered employees because of the
                                                                                                                          employees) based on the railroad                               lack of data to gauge the extent of the
                                                Executive Secretary to the Department,
                                                Department of Health and Human Services.                                  industry data available for the two                            drug abuse problem at that time. FRA
                                                                                                                          previous calendar years (for this Notice,                      set its minimum random alcohol testing
                                                [FR Doc. 2016–31019 Filed 12–22–16; 8:45 am]
                                                                                                                          calendar years 2014 and 2015). Railroad                        rate for covered employees at 25 percent
                                                BILLING CODE 4120–01–P
                                                                                                                          industry data submitted to FRA’s                               for the same reason. As its MIS data
                                                                                                                          Management Information System (MIS)                            continued to show consistently low
                                                                                                                          shows the rail industry’s random drug                          industry-wide drug and alcohol positive
                                                DEPARTMENT OF TRANSPORTATION                                              testing positive rate for covered service                      rates among covered employees, FRA
                                                                                                                          employees has continued to be below                            lowered its minimum annual random
                                                Federal Railroad Administration                                           1.0 percent for the applicable two                             drug and alcohol testing rates to their
                                                                                                                          calendar years. FRA’s Administrator has
                                                49 CFR Part 219                                                                                                                          current respective rates of 25 and 10
                                                                                                                          therefore determined the minimum
                                                                                                                                                                                         percent.
                                                [Docket No. FRA–2001–11213, Notice No.                                    annual random drug testing rate for the
                                                21]                                                                       period January 1, 2017, through                                  Similarly, because FRA has no MIS
                                                                                                                          December 31, 2017, will remain at 25                           data for MOW employees yet, the
                                                Drug and Alcohol Testing:                                                 percent of covered service employees                           Administrator has determined that for
                                                Determination of Minimum Random                                           under § 219.602 of FRA’s drug and                              the period June 12, 2017, through
                                                Testing Rates for 2017                                                    alcohol rule (49 CFR part 219). In                             December 31, 2017, the minimum
                                                                                                                          addition, because the industry-wide                            annual random drug testing rate will be
                                                AGENCY: Federal Railroad
                                                                                                                          random alcohol testing violation rate for                      set at 50 percent of MOW employees,
                                                Administration (FRA), Department of
                                                                                                                          covered service employees has                                  and the minimum annual random
                                                Transportation (DOT).
                                                                                                                          continued to be below 0.5 percent for                          alcohol testing rate will be set at 25
                                                ACTION: Notice of determination.                                                                                                         percent of MOW employees. As with
                                                                                                                          the applicable two calendar years, the
                                                SUMMARY:   This notice of determination                                   Administrator has determined the                               covered employees, because these rates
                                                provides the FRA Administrator’s                                          minimum random alcohol testing rate                            represent minimums, railroads may
                                                minimum annual random drug and                                            will remain at 10 percent of covered                           conduct FRA random testing of MOW
                                                alcohol testing rates for calendar year                                   service employees for the period                               employees at higher rates.
jstallworth on DSK7TPTVN1PROD with RULES




                                                2017.                                                                     January 1, 2017, through December 31,                            Issued in Washington, DC, on December
                                                                                                                          2017, under § 219.608. Because these                           20, 2016.
                                                DATES:Effective December 23, 2016.                                        rates represent minimums, railroads
                                                                                                                                                                                         Sarah E. Feinberg,
                                                FOR FURTHER INFORMATION CONTACT:  Jerry                                   may conduct FRA random testing at
                                                Powers, FRA Drug and Alcohol Program                                      higher rates.                                                  Administrator.
                                                Manager, W33–310, Federal Railroad                                           In a June 10, 2016, final rule, FRA                         [FR Doc. 2016–31009 Filed 12–22–16; 8:45 am]
                                                Administration, 1200 New Jersey                                           expanded the scope of part 219 to cover                        BILLING CODE 4910–06–P




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Document Created: 2016-12-23 12:30:06
Document Modified: 2016-12-23 12:30:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; correction.
DatesThis correction is effective on January 1, 2017.
ContactJulia 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.
FR Citation81 FR 94268 
CFR Citation42 CFR 413
42 CFR 414
42 CFR 494

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