[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Proposed Rules]
[Pages 17620-17690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08108]



[[Page 17619]]

Vol. 84

Thursday,

No. 80

April 25, 2019

Part IV





Department of Health and Human Services





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





Centers for Medicare & Medicaid Services





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





42 CFR Parts 409 and 413





Medicare Program; Prospective Payment System and Consolidated Billing 
for Skilled Nursing Facilities; Updates to the Quality Reporting 
Program and Value-Based Purchasing Program for Federal Fiscal Year 
2020; Proposed Rule

  Federal Register / Vol. 84 , No. 80 / Thursday, April 25, 2019 / 
Proposed Rules  

[[Page 17620]]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409 and 413

[CMS-1718-P]
RIN 0938-AT75


Medicare Program; Prospective Payment System and Consolidated 
Billing for Skilled Nursing Facilities; Updates to the Quality 
Reporting Program and Value-Based Purchasing Program for Federal Fiscal 
Year 2020

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

ACTION: Proposed rule.

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

SUMMARY: This proposed rule would update the payment rates used under 
the prospective payment system (PPS) for skilled nursing facilities 
(SNFs) for fiscal year (FY) 2020. We also propose minor revisions to 
the regulation text to reflect the revised assessment schedule under 
Patient Driven Payment Model (PDPM). Additionally, we propose to revise 
the definition of group therapy under the SNF PPS, and to implement a 
subregulatory process for updating the code lists (International 
Classification of Diseases, Tenth Version (ICD-10) codes) used under 
PDPM. We are also soliciting comments on stakeholder concerns regarding 
the appropriateness of the wage index used to adjust SNF payments. In 
addition, the proposed rule includes proposals for the SNF Quality 
Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) 
Program that will affect Medicare payment to SNFs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on June 18, 2019.

ADDRESSES: In commenting, please refer to file code CMS-1718-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1718-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    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-1718-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Penny Gershman, (410) 786-6643, for 
information related to SNF PPS clinical issues.
    Anthony Hodge, (410) 786-6645, for information related to payment 
for SNF-level swing-bed services.
    John Kane, (410) 786-0557, for information related to the 
development of the payment rates and case-mix indexes, and general 
information.
    Kia Sidbury, (410) 786-7816, for information related to the wage 
index.
    Bill Ullman, (410) 786-5667, for information related to level of 
care determinations and consolidated billing.
    Casey Freeman, (410) 786-4354, for information related to skilled 
nursing facility quality reporting program.
    James Poyer, (410) 786-2261, for information related to the skilled 
nursing facility value-based purchasing program.

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 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments.

Availability of Certain Tables Exclusively Through the Internet on the 
CMS Website

    As discussed in the FY 2014 SNF PPS final rule (78 FR 47936), 
tables setting forth the Wage Index for Urban Areas Based on CBSA Labor 
Market Areas and the Wage Index Based on CBSA Labor Market Areas for 
Rural Areas are no longer published in the Federal Register. Instead, 
these tables are available exclusively through the internet on the CMS 
website. The wage index tables for this proposed rule can be accessed 
on the SNF PPS Wage Index home page, at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
    Readers who experience any problems accessing any of these online 
SNF PPS wage index tables should contact Kia Sidbury at (410) 786-7816.
    To assist readers in referencing sections contained in this 
document, we are providing the following Table of Contents.

Table of Contents

I. Executive Summary
    A. Purpose
    B. Summary of Major Provisions
    C. Summary of Cost and Benefits
    D. Advancing Health Information Exchange
II. Background on SNF PPS
    A. Statutory Basis and Scope
    B. Initial Transition for the SNF PPS
    C. Required Annual Rate Updates
III. Proposed SNF PPS Rate Setting Methodology and FY 2020 Update
    A. Federal Base Rates
    B. SNF Market Basket Update
    C. Case-Mix Adjustment
    D. Wage Index Adjustment
    E. Wage Index Comment Solicitation
    F. SNF Value-Based Purchasing Program
    G. Adjusted Rate Computation Example
IV. Additional Aspects of the SNF PPS
    A. SNF Level of Care--Administrative Presumption
    B. Consolidated Billing
    C. Payment for SNF-Level Swing-Bed Services
V. Issues Relating to PDPM Implementation
    A. Revised Group Therapy Definition
    B. Updating ICD-10 Code Mappings
    C. Revisions to the Regulation Text
VI. Other Issues
    A. Skilled Nursing Facility (SNF) Quality Reporting Program 
(QRP)
    B. Skilled Nursing Facility Value-Based Purchasing Program (SNF 
VBP)
VII. Collection of Information Requirements
VIII. Response to Comments
IX. Economic Analyses
Regulations Text

I. Executive Summary

A. Purpose

    This proposed rule would update the SNF prospective payment rates 
for fiscal year (FY) 2020 as required under section 1888(e)(4)(E) of 
the Social Security Act (the Act). It would also respond to section 
1888(e)(4)(H) of the Act, which requires the Secretary to provide for 
publication in the Federal Register, before the August 1 that precedes 
the start of each FY, certain specified information relating to the 
payment update (see section II.C. of this proposed rule). This proposed 
rule also proposes to revise the definition of group therapy under the 
SNF PPS and to implement a subregulatory process for updating ICD-10 
code lists used under the PDPM.

[[Page 17621]]

Finally, this proposed rule would also update the Skilled Nursing 
Facility Quality Reporting Program (SNF QRP) and Skilled Nursing 
Facility Value-Based Purchasing Program (SNF VBP).

B. Summary of Major Provisions

    In accordance with sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5) of 
the Act, the federal rates in this proposed rule would reflect an 
update to the rates that we published in the SNF PPS final rule for FY 
2019 (83 FR 39162), as corrected in the FY 2019 SNF PPS correction 
notice (83 FR 49832), which reflects the SNF market basket update, as 
adjusted by the multifactor productivity (MFP) adjustment, for FY 2020. 
In addition, we are proposing to revise the definition of group therapy 
under the SNF PPS and to implement a subregulatory process for updating 
ICD-10 code lists used under the PDPM.
    This proposed rule proposes to update requirements for the SNF QRP, 
including the proposal of two Transfer of Health Information quality 
measures as well as standardized patient assessment data elements to 
begin collection on October 1, 2020 in satisfaction of the Improving 
Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. 
L. 113-185, enacted October 6, 2014). We are also proposing to exclude 
baseline nursing home residents from the Discharge to Community 
Measure. In addition, we are proposing to expand data collection for 
SNF QRP quality measures to all skilled nursing facility residents, 
regardless of their payer. Further, we are also proposing the public 
display of the quality measure, Drug Regimen Review Conducted With 
Follow-Up for Identified Issues- Post Acute Care (PAC) Skilled Nursing 
Facility (SNF) Quality Reporting Program (QRP). We are also proposing 
to revise references in regulation text to reflect enhancements to the 
system used for the submission of data. Finally, we are requesting 
information on quality measures and standardized resident assessment 
data elements under consideration for future years.
    In accordance with section 1888(h) of the Act, this proposed rule 
would update certain policies for the SNF VBP.

C. Summary of Cost and Benefits

                       Table 1--Cost and Benefits
------------------------------------------------------------------------
         Provision description                   Total transfers
------------------------------------------------------------------------
FY 2020 SNF PPS payment rate update....  The overall economic impact of
                                          this proposed rule is an
                                          estimated increase of $887
                                          million in aggregate payments
                                          to SNFs during FY 2020.
FY 2020 SNF VBP changes................  The overall economic impact of
                                          the SNF VBP Program is an
                                          estimated reduction of $213.6
                                          million in aggregate payments
                                          to SNFs during FY 2020.
------------------------------------------------------------------------

D. Advancing Health Information Exchange

    The Department of Health and Human Services (HHS) has a number of 
initiatives designed to encourage and support the adoption of 
interoperable health information technology and to promote nationwide 
health information exchange to improve health care. The Office of the 
National Coordinator for Health Information Technology (ONC) and CMS 
work collaboratively to advance interoperability across settings of 
care, including post-acute care.
    To further interoperability in post-acute care, we developed a Data 
Element Library (DEL) to serve as a publicly available centralized, 
authoritative resource for standardized data elements and their 
associated mappings to health IT standards. The DEL furthers CMS' goal 
of data standardization and interoperability, which is also a goal of 
the Improving Medicare Post-Acute Care Transformation Act of 2014 
(IMPACT Act). These interoperable data elements can reduce provider 
burden by allowing the use and exchange of healthcare data, support 
provider exchange of electronic health information for care 
coordination, person-centered care, and support real-time, data driven, 
clinical decision making. Standards in the Data Element Library 
(https://del.cms.gov/) can be referenced on the CMS website and in the 
ONC Interoperability Standards Advisory (ISA). The 2019 ISA is 
available at https://www.healthit.gov/isa.
    The 21st Century Cures Act (the Cures Act) (Pub. L. 114-255, 
enacted December 13, 2016) requires HHS to take new steps to enable the 
electronic sharing of health information ensuring interoperability for 
providers and settings across the care continuum. In another important 
provision, Congress defined ``information blocking'' as practices 
likely to interfere with, prevent, or materially discourage access, 
exchange, or use of electronic health information, and established new 
authority for HHS to discourage these practices. In March 2019, ONC and 
CMS published the proposed rules, ``21st Century Cures Act: 
Interoperability, Information Blocking, and the ONC Health IT 
Certification Program,'' (84 FR 7424) and ``Interoperability and 
Patient Access'' (84 FR 7610) to promote secure and more immediate 
access to health information for patients and healthcare providers 
through the implementation of information blocking provisions of the 
Cures Act and the use of standardized application programming 
interfaces (APIs) that enable easier access to electronic health 
information. These two proposed rules are open for public comment at 
www.regulations.gov. We invite providers to learn more about these 
important developments and how they are likely to affect SNFs.

II. Background on SNF PPS

A. Statutory Basis and Scope

    As amended by section 4432 of the Balanced Budget Act of 1997 (BBA 
1997) (Pub. L. 105-33, enacted on August 5, 1997), section 1888(e) of 
the Act provides for the implementation of a PPS for SNFs. This 
methodology uses prospective, case-mix adjusted per diem payment rates 
applicable to all covered SNF services defined in section 1888(e)(2)(A) 
of the Act. The SNF PPS is effective for cost reporting periods 
beginning on or after July 1, 1998, and covers all costs of furnishing 
covered SNF services (routine, ancillary, and capital-related costs) 
other than costs associated with approved educational activities and 
bad debts. Under section 1888(e)(2)(A)(i) of the Act, covered SNF 
services include post-hospital extended care services for which 
benefits are provided under Part A, as well as those items and services 
(other than a small number of excluded services, such as physicians' 
services) for which payment may otherwise be made under Part B and 
which are furnished to Medicare beneficiaries who are residents in a 
SNF during a covered Part A stay. A comprehensive discussion of these 
provisions appears in the May 12, 1998

[[Page 17622]]

interim final rule (63 FR 26252). In addition, a detailed discussion of 
the legislative history of the SNF PPS is available online at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Legislative_History_2018-10-01.pdf.
    Section 215(a) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added section 1888(g) 
to the Act requiring the Secretary to specify an all-cause all-
condition hospital readmission measure and an all-condition risk-
adjusted potentially preventable hospital readmission measure for the 
SNF setting. Additionally, section 215(b) of PAMA added section 1888(h) 
to the Act requiring the Secretary to implement a VBP program for SNFs. 
Finally, section 2(c)(4) of the IMPACT Act amended section 1888(e)(6) 
to the Act, which requires the Secretary to implement a quality 
reporting program for SNFs under which SNFs report data on measures and 
resident assessment data.

B. Initial Transition for the SNF PPS

    Under sections 1888(e)(1)(A) and 1888(e)(11) of the Act, the SNF 
PPS included an initial, three-phase transition that blended a 
facility-specific rate (reflecting the individual facility's historical 
cost experience) with the federal case-mix adjusted rate. The 
transition extended through the facility's first 3 cost reporting 
periods under the PPS, up to and including the one that began in FY 
2001. Thus, the SNF PPS is no longer operating under the transition, as 
all facilities have been paid at the full federal rate effective with 
cost reporting periods beginning in FY 2002. As we now base payments 
for SNFs entirely on the adjusted federal per diem rates, we no longer 
include adjustment factors under the transition related to facility-
specific rates for the upcoming FY.

C. Required Annual Rate Updates

    Section 1888(e)(4)(E) of the Act requires the SNF PPS payment rates 
to be updated annually. The most recent annual update occurred in a 
final rule that set forth updates to the SNF PPS payment rates for FY 
2019 (83 FR 39162), as corrected in the FY 2019 SNF PPS correction 
notice (83 FR 49832).
    Section 1888(e)(4)(H) of the Act specifies that we provide for 
publication annually in the Federal Register of the following:
     The unadjusted federal per diem rates to be applied to 
days of covered SNF services furnished during the upcoming FY.
     The case-mix classification system to be applied for these 
services during the upcoming FY.
     The factors to be applied in making the area wage 
adjustment for these services.
    Along with other revisions discussed later in this preamble, this 
proposed rule will provide the required annual updates to the per diem 
payment rates for SNFs for FY 2020.

III. Proposed SNF PPS Rate Setting Methodology and FY 2020 Update

A. Federal Base Rates

    Under section 1888(e)(4) of the Act, the SNF PPS uses per diem 
federal payment rates based on mean SNF costs in a base year (FY 1995) 
updated for inflation to the first effective period of the PPS. We 
developed the federal payment rates using allowable costs from 
hospital-based and freestanding SNF cost reports for reporting periods 
beginning in FY 1995. The data used in developing the federal rates 
also incorporated a Part B add-on, which is an estimate of the amounts 
that, prior to the SNF PPS, would be payable under Part B for covered 
SNF services furnished to individuals during the course of a covered 
Part A stay in a SNF.
    In developing the rates for the initial period, we updated costs to 
the first effective year of the PPS (the 15-month period beginning July 
1, 1998) using a SNF market basket index, and then standardized for 
geographic variations in wages and for the costs of facility 
differences in case mix. In compiling the database used to compute the 
federal payment rates, we excluded those providers that received new 
provider exemptions from the routine cost limits, as well as costs 
related to payments for exceptions to the routine cost limits. Using 
the formula that the BBA 1997 prescribed, we set the federal rates at a 
level equal to the weighted mean of freestanding costs plus 50 percent 
of the difference between the freestanding mean and weighted mean of 
all SNF costs (hospital-based and freestanding) combined. We computed 
and applied separately the payment rates for facilities located in 
urban and rural areas, and adjusted the portion of the federal rate 
attributable to wage-related costs by a wage index to reflect 
geographic variations in wages.

B. SNF Market Basket Update

1. SNF Market Basket Index
    Section 1888(e)(5)(A) of the Act requires us to establish a SNF 
market basket index that reflects changes over time in the prices of an 
appropriate mix of goods and services included in covered SNF services. 
Accordingly, we have developed a SNF market basket index that 
encompasses the most commonly used cost categories for SNF routine 
services, ancillary services, and capital-related expenses. In the SNF 
PPS final rule for FY 2018 (82 FR 36548 through 36566), we revised and 
rebased the market basket index, which included updating the base year 
from FY 2010 to 2014.
    The SNF market basket index is used to compute the market basket 
percentage change that is used to update the SNF federal rates on an 
annual basis, as required by section 1888(e)(4)(E)(ii)(IV) of the Act. 
This market basket percentage update is adjusted by a forecast error 
correction, if applicable, and then further adjusted by the application 
of a productivity adjustment as required by section 1888(e)(5)(B)(ii) 
of the Act and described in section III.B.4. of this proposed rule. For 
FY 2020, the growth rate of the 2014-based SNF market basket is 
estimated to be 3.0 percent, based on the IHS Global Insight, Inc. 
(IGI) first quarter 2019 forecast with historical data through fourth 
quarter 2018, before the multifactor productivity adjustment is 
applied.
    In section III.B.5. of this proposed rule, we discuss the 2 percent 
reduction applied to the market basket update for those SNFs that fail 
to submit measures data as required by section 1888(e)(6)(A) of the 
Act.
2. Use of the SNF Market Basket Percentage
    Section 1888(e)(5)(B) of the Act defines the SNF market basket 
percentage as the percentage change in the SNF market basket index from 
the midpoint of the previous FY to the midpoint of the current FY. For 
the federal rates set forth in this proposed rule, we use the 
percentage change in the SNF market basket index to compute the update 
factor for FY 2020. This factor is based on the FY 2020 percentage 
increase in the 2014-based SNF market basket index reflecting routine, 
ancillary, and capital-related expenses. In this proposed rule, the SNF 
market basket percentage is estimated to be 3.0 percent for FY 2020 
based on IGI's first quarter 2019 forecast (with historical data 
through fourth quarter 2018). Finally, as discussed in section II.B. of 
this proposed rule, we no longer compute update factors to adjust a 
facility-specific portion of the SNF PPS rates, because the initial 
three-phase transition period from facility-specific to full federal 
rates that started with cost reporting periods beginning in July 1998 
has expired.

[[Page 17623]]

3. Forecast Error Adjustment
    As discussed in the June 10, 2003 supplemental proposed rule (68 FR 
34768) and finalized in the August 4, 2003 final rule (68 FR 46057 
through 46059), Sec.  413.337(d)(2) provides for an adjustment to 
account for market basket forecast error. The initial adjustment for 
market basket forecast error applied to the update of the FY 2003 rate 
for FY 2004, and took into account the cumulative forecast error for 
the period from FY 2000 through FY 2002, resulting in an increase of 
3.26 percent to the FY 2004 update. Subsequent adjustments in 
succeeding FYs take into account the forecast error from the most 
recently available FY for which there is final data, and apply the 
difference between the forecasted and actual change in the market 
basket when the difference exceeds a specified threshold. We originally 
used a 0.25 percentage point threshold for this purpose; however, for 
the reasons specified in the FY 2008 SNF PPS final rule (72 FR 43425, 
August 3, 2007), we adopted a 0.5 percentage point threshold effective 
for FY 2008 and subsequent FYs. As we stated in the final rule for FY 
2004 that first issued the market basket forecast error adjustment (68 
FR 46058, August 4, 2003), the adjustment will reflect both upward and 
downward adjustments, as appropriate.
    For FY 2018 (the most recently available FY for which there is 
final data), the estimated increase in the market basket index was 2.6 
percentage points, and the actual increase for FY 2018 is 2.6 
percentage points, resulting in the actual increase being the same as 
the estimated increase. Accordingly, as the difference between the 
estimated and actual amount of change in the market basket index does 
not exceed the 0.5 percentage point threshold, the FY 2020 market 
basket percentage change of 3.0 percent would not be adjusted to 
account for the forecast error correction. Table 2 shows the forecasted 
and actual market basket amounts for FY 2018.

            Table 2--Difference Between the Forecasted and Actual Market Basket Increases for FY 2018
----------------------------------------------------------------------------------------------------------------
                                                                Forecasted FY    Actual FY 2018      FY 2018
                            Index                              2018 increase *    increase **       difference
----------------------------------------------------------------------------------------------------------------
SNF..........................................................             2.6              2.6              0.0
----------------------------------------------------------------------------------------------------------------
* Published in Federal Register; based on second quarter 2017 IGI forecast (2010-based index).
** Based on the first quarter 2019 IGI forecast, with historical data through the fourth quarter 2018 (2010-
  based index).

4. Multifactor Productivity Adjustment
    Section 1888(e)(5)(B)(ii) of the Act, as added by section 3401(b) 
of the Patient Protection and Affordable Care Act (Affordable Care Act) 
(Pub. L. 111-148, enacted on March 23, 2010) requires that, in FY 2012 
and in subsequent FYs, the market basket percentage under the SNF 
payment system (as described in section 1888(e)(5)(B)(i) of the Act) is 
to be reduced annually by the multifactor productivity (MFP) adjustment 
described in section 1886(b)(3)(B)(xi)(II) of the Act. Section 
1886(b)(3)(B)(xi)(II) of the Act, in turn, defines the MFP adjustment 
to be equal to the 10-year moving average of changes in annual economy-
wide private nonfarm business multi-factor productivity (as projected 
by the Secretary for the 10-year period ending with the applicable FY, 
year, cost-reporting period, or other annual period). The Bureau of 
Labor Statistics (BLS) is the agency that publishes the official 
measure of private nonfarm business MFP. We refer readers to the BLS 
website at http://www.bls.gov/mfp for the BLS historical published MFP 
data.
    MFP is derived by subtracting the contribution of labor and capital 
inputs growth from output growth. The projections of the components of 
MFP are currently produced by IGI, a nationally recognized economic 
forecasting firm with which CMS contracts to forecast the components of 
the market baskets and MFP. To generate a forecast of MFP, IGI 
replicates the MFP measure calculated by the BLS, using a series of 
proxy variables derived from IGI's U.S. macroeconomic models. For a 
discussion of the MFP projection methodology, we refer readers to the 
FY 2012 SNF PPS final rule (76 FR 48527 through 48529) and the FY 2016 
SNF PPS final rule (80 FR 46395). A complete description of the MFP 
projection methodology is available on our website at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html.
a. Incorporating the MFP Adjustment Into the Market Basket Update
    Per section 1888(e)(5)(A) of the Act, the Secretary shall establish 
a SNF market basket index that reflects changes over time in the prices 
of an appropriate mix of goods and services included in covered SNF 
services. Section 1888(e)(5)(B)(ii) of the Act, added by section 
3401(b) of the Affordable Care Act, requires that for FY 2012 and each 
subsequent FY, after determining the market basket percentage described 
in section 1888(e)(5)(B)(i) of the Act, the Secretary shall reduce such 
percentage by the productivity adjustment described in section 
1886(b)(3)(B)(xi)(II) of the Act (which we refer to as the MFP 
adjustment). Section 1888(e)(5)(B)(ii) of the Act further states that 
the reduction of the market basket percentage by the MFP adjustment may 
result in the market basket percentage being less than zero for a FY, 
and may result in payment rates under section 1888(e) of the Act being 
less than such payment rates for the preceding fiscal year. Thus, if 
the application of the MFP adjustment to the market basket percentage 
calculated under section 1888(e)(5)(B)(i) of the Act results in an MFP-
adjusted market basket percentage that is less than zero, then the 
annual update to the unadjusted federal per diem rates under section 
1888(e)(4)(E)(ii) of the Act would be negative, and such rates would 
decrease relative to the prior FY.
    The MFP adjustment, calculated as the 10-year moving average of 
changes in MFP for the period ending September 30, 2020, is estimated 
to be 0.5 percent based on IGI's first quarter 2019 forecast. Also, 
consistent with section 1888(e)(5)(B)(i) of the Act and Sec.  
413.337(d)(2), the market basket percentage for FY 2020 for the SNF PPS 
is based on IGI's first quarter 2019 forecast of the SNF market basket 
percentage, which is estimated to be 3.0 percent. In accordance with 
section 1888(e)(5)(B)(ii) of the Act and Sec.  413.337(d)(3), this 
market basket percentage is then reduced by the MFP adjustment of 0.5 
percent. The resulting MFP-adjusted SNF market basket update would be 
equal to 2.5 percent, or 3.0 percent less 0.5 percentage point.

[[Page 17624]]

5. Market Basket Update Factor for FY 2020
    Sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5)(i) of the Act require 
that the update factor used to establish the FY 2020 unadjusted federal 
rates be at a level equal to the market basket index percentage change. 
Accordingly, we determined the total growth from the average market 
basket level for the period of October 1, 2018, through September 30, 
2019 to the average market basket level for the period of October 1, 
2019, through September 30, 2020. This process yields a percentage 
change in the 2014-based SNF market basket of 3.0 percent. As further 
explained in section III.B.3. of this proposed rule, as applicable, we 
adjust the market basket percentage change by the forecast error from 
the most recently available FY for which there is final data and apply 
this adjustment whenever the difference between the forecasted and 
actual percentage change in the market basket exceeds a 0.5 percentage 
point threshold. Since the difference between the forecasted FY 2018 
SNF market basket percentage change and the actual FY 2018 SNF market 
basket percentage change (FY 2018 is the most recently available FY for 
which there is historical data) did not exceed the 0.5 percentage point 
threshold, the FY 2020 market basket percentage change of 3.0 percent 
would not be adjusted by the forecast error correction.
    Section 1888(e)(5)(B)(ii) of the Act requires us to reduce the 
market basket percentage change by the MFP adjustment (10-year moving 
average of changes in MFP for the period ending September 30, 2020) of 
0.5 percent, as described in section III.B.4 of this proposed rule. The 
resulting net SNF market basket update would equal 2.5 percent, or 3.0 
percent less the 0.5 percentage point MFP adjustment. We note that our 
policy has been that, if more recent data become available (for 
example, a more recent estimate of the SNF market basket and/or MFP 
adjustment), we would use such data, if appropriate, to determine the 
SNF market basket percentage change, labor-related share relative 
importance, forecast error adjustment, and MFP adjustment in the SNF 
PPS final rule.
    We also note that section 1888(e)(6)(A)(i) of the Act provides 
that, beginning with FY 2018, SNFs that fail to submit data, as 
applicable, in accordance with sections 1888(e)(6)(B)(i)(II) and (III) 
of the Act for a fiscal year will receive a 2.0 percentage point 
reduction to their market basket update for the fiscal year involved, 
after application of section 1888(e)(5)(B)(ii) of the Act (the MFP 
adjustment) and section 1888(e)(5)(B)(iii) of the Act (the 1 percent 
market basket increase for FY 2018). In addition, section 
1888(e)(6)(A)(ii) of the Act states that application of the 2.0 
percentage point reduction (after application of section 
1888(e)(5)(B)(ii) and (iii) of the Act) may result in the market basket 
index percentage change being less than 0.0 for a fiscal year, and may 
result in payment rates for a fiscal year being less than such payment 
rates for the preceding fiscal year. Section 1888(e)(6)(A)(iii) of the 
Act further specifies that the 2.0 percentage point reduction is 
applied in a noncumulative manner, so that any reduction made under 
section 1888(e)(6)(A)(i) of the Act applies only with respect to the 
fiscal year involved, and that the reduction cannot be taken into 
account in computing the payment amount for a subsequent fiscal year.
    Accordingly, for the reasons specified in this proposed rule, we 
are proposing to apply the FY 2020 SNF market basket increase factor of 
2.5 percent in our determination of the FY 2020 SNF PPS unadjusted 
federal per diem rates, which reflects a market basket increase factor 
of 3.0 percent, less the 0.5 percentage point MFP-adjustment.
6. Unadjusted Federal per Diem Rates for FY 2020
    As discussed in the FY 2019 SNF PPS final rule (83 FR 39162), we 
are implementing a new case-mix classification system to classify SNF 
patients under the SNF PPS, beginning in FY 2020, called the Patient 
Driven Payment Model (PDPM). As discussed in section V.B of that final 
rule, under PDPM, the unadjusted Federal per diem rates are divided 
into six components, five of which are case-mix adjusted components 
(Physical Therapy (PT), Occupational Therapy (OT), Speech-Language 
Pathology (SLP), Nursing, and Non-Therapy Ancillaries (NTA)), and one 
of which is a non-case-mix component, as exists under RUG-IV. In 
calculating the FY 2020 unadjusted Federal per diem rates that would be 
used under PDPM in FY 2020, we applied the FY 2020 MFP-adjusted market 
basket increase factor to the unadjusted Federal per diem rates 
provided in Tables 4 and 5 of the FY 2019 SNF PPS final rule (83 FR 
39169) and then applied the methodology for separating the RUG-IV base 
rates into the PDPM base rates, as discussed and finalized in section 
V.B.3 of the FY 2019 SNF PPS final rule (83 FR 39191 through 39194).
    Tables 3 and 4 reflect the proposed updated unadjusted federal 
rates for FY 2020, prior to adjustment for case-mix.

                                                Table 3--FY 2020 Unadjusted Federal Rate Per Diem--Urban
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Rate component                           PT               OT              SLP            Nursing            NTA          Non-case-mix
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per Diem Amount...................................          $61.16           $56.93           $22.83          $106.64           $80.45           $95.48
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 17625]]


                                                Table 4--FY 2020 Unadjusted Federal Rate Per Diem--Rural
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Rate component                           PT               OT              SLP            Nursing            NTA          Non-case-mix
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per Diem Amount...................................          $69.72           $64.03           $28.76          $101.88           $76.86           $97.25
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Case-Mix Adjustment

    Under section 1888(e)(4)(G)(i) of the Act, the federal rate also 
incorporates an adjustment to account for facility case-mix, using a 
classification system that accounts for the relative resource 
utilization of different patient types. The statute specifies that the 
adjustment is to reflect both a resident classification system that the 
Secretary establishes to account for the relative resource use of 
different patient types, as well as resident assessment data and other 
data that the Secretary considers appropriate. In the FY 2019 final 
rule (83 FR 39162, August 8, 2018), we finalized a new case-mix 
classification model, the PDPM, to take effect beginning October 1, 
2019. The RUG-IV model classifies most patients into a therapy payment 
group and primarily uses the volume of therapy services provided to the 
patient as the basis for payment classification, thus inadvertently 
creating an incentive for SNFs to furnish therapy regardless of the 
individual patient's unique characteristics, goals, or needs. PDPM 
eliminates this incentive and improves the overall accuracy and 
appropriateness of SNF payments by classifying patients into payment 
groups based on specific, data-driven patient characteristics, while 
simultaneously reducing the administrative burden on SNFs.
    The PDPM (like the RUG-IV) uses clinical data from the MDS to 
assign case-mix classifiers to each patient that are then used to 
calculate a per diem payment under the SNF PPS. As discussed in section 
IV.A. of this proposed rule, the clinical orientation of the case-mix 
classification system supports the SNF PPS's use of an administrative 
presumption that considers a beneficiary's initial case-mix 
classification to assist in making certain SNF level of care 
determinations. Further, because the MDS is used as a basis for 
payment, as well as a clinical assessment, we have provided extensive 
training on proper coding and the timeframes for MDS completion in our 
Resident Assessment Instrument (RAI) Manual. For an MDS to be 
considered valid for use in determining payment, the MDS assessment 
must be completed in compliance with the instructions in the RAI Manual 
in effect at the time the assessment is completed. For payment and 
quality monitoring purposes, the RAI Manual consists of both the Manual 
instructions and the interpretive guidance and policy clarifications 
posted on the appropriate MDS website at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html.
    Under section 1888(e)(4)(H), each update of the payment rates must 
include the case-mix classification methodology applicable for the 
upcoming FY. The FY 2020 payment rates set forth in this proposed rule 
reflect the use of the PDPM case-mix classification system from October 
1, 2019, through September 30, 2020. We list the proposed case-mix 
adjusted PDPM payment rates for FY 2020, provided separately for urban 
and rural SNFs, in Tables 6 and 7 with corresponding case-mix values.
    As discussed in the FY 2019 SNF PPS final rule (83 FR 39255 through 
39256), we finalized the implementation of PDPM in a budget neutral 
manner. To accomplish this, as discussed in the FY 2019 SNF PPS final 
rule (83 FR 39256), the unadjusted PDPM case mix indexes (CMIs) were 
multiplied by 1.46 so that the total estimated payments under the PDPM 
would be equal to the total actual payments under RUG-IV. Further, 
section 3.11.2 of the PDPM technical report, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/PDPM_Technical_Report_508.pdf, provided additional detail on the 
calculation of the PDPM CMIs in order to achieve budget neutrality. In 
that section, it states that ``to align the distribution of resources 
across components with the statutory base rates, Acumen set CMIs such 
that the average product of the CMI and the variable per diem 
adjustment factor for a day of care is the same (set to 1) for each of 
the five case-mix-adjusted components in PDPM. To do this, Acumen first 
calculated the product of the CMI and the adjustment factor for every 
utilization day for each component. Then, we calculated the average of 
this product for each component. Finally, Acumen calculated the ratio 
of 1 divided by the average product for each component. This ratio is 
the standardization multiplier, shown in Table 65 for each component.'' 
As discussed in section 3.11.2 of the PDPM Technical Report, the 
standardization multiplier is used to align the distribution of 
resources across components with the statutory base rates by setting 
the CMIs such that the average product of the component CMI and the 
variable per diem adjustment factor for that component for a day of 
care is the same. Effectively, the standardization multiplier is used 
to mitigate the effect of the variable per diem adjustment when 
calculating budget neutrality. The CMIs were adjusted such that total 
payments under PDPM, if it had been in effect in FY 2017, equal total 
actual payments made under RUG-IV in FY 2017.
    In this proposed rule, we propose to update the payment year used 
as the basis for the calculation of the standardization multiplier and 
budget neutrality multiplier, in order to best ensure that PDPM will be 
implemented in a budget neutral manner, as finalized in the FY 2019 SNF 
PPS final rule. The only difference in methodology between that used to 
calculate these multipliers and CMIs in the FY 2019 SNF PPS final rule 
and that used to calculate the multipliers and CMIs in this proposed 
rule is that, in this proposed rule, we are updating the data used from 
FY 2017 data to FY 2018 data. The impact of using the updated FY 2018 
data and the proposed updated adjustment multipliers for 
standardization and budget neutrality, is provided in Table 5. We would 
note that while the multipliers discussed in the FY 2019 SNF PPS final 
rule and in the PDPM Technical Report are given to the hundredths 
place, in order to make clear the effect of this change in data, the 
multipliers in Table 5 are shown to the thousandths place. The CMIs 
provided in Tables 6 and 7 reflect the use of the proposed multipliers 
in Table 5, based on the update to FY 2018 data.

[[Page 17626]]



                    Table 5--Proposed PDPM Standardization and Budget Neutrality Multipliers
----------------------------------------------------------------------------------------------------------------
                                                  FY 2017 data                          FY 2018 data
                                     ---------------------------------------------------------------------------
              Component                Standardization   Budget neutrality   Standardization   Budget neutrality
                                          multiplier         multiplier         multiplier         multiplier
----------------------------------------------------------------------------------------------------------------
PT..................................              1.031              1.458              1.028              1.463
OT..................................              1.030              1.458              1.028              1.463
SLP.................................              0.995              1.458              0.996              1.463
Nursing.............................              0.995              1.458              0.996              1.463
NTA.................................              0.817              1.458              0.811              1.463
----------------------------------------------------------------------------------------------------------------

    Given the differences between RUG-IV and PDPM in terms of patient 
classification and billing, it is important that the format of Tables 6 
and 7 reflect these differences. More specifically, under both RUG-IV 
and PDPM, providers use a Health Insurance Prospective Payment System 
(HIPPS) code on a claim in order to bill for covered SNF services. 
Under RUG-IV, the HIPPS code includes the three character RUG-IV group 
into which the patient classifies as well as a two character assessment 
indicator code that represents the assessment used to generate this 
code. Under PDPM, while providers would still use a HIPPS code, the 
characters in that code represent different things. For example, the 
first character represents the PT and OT group into which the patient 
classifies. If the patient is classified into the PT and OT group 
``TA'', then the first character in the patient's HIPPS code would be 
an A. Similarly, if the patient is classified into the SLP group 
``SB'', then the second character in the patient's HIPPS code would be 
a B. The third character represents the Nursing group into which the 
patient classifies. The fourth character represents the NTA group into 
which the patient classifies. Finally, the fifth character represents 
the assessment used to generate the HIPPS code.
    Therefore, we have modified the format of Tables 6 and 7 from what 
we have used for similar tables in prior SNF PPS rulemaking, such as 
Tables 6 and 7 of the FY 2019 SNF PPS final rule (83 FR 39170 through 
39172). Column 1 of Tables 6 and 7 represents the character in the 
HIPPS code associated with a given PDPM component. Columns 2 and 3 
provide the case-mix index and associated case-mix adjusted component 
rate, respectively, for the relevant PT group. Columns 4 and 5 provide 
the case-mix index and associated case-mix adjusted component rate, 
respectively, for the relevant OT group. Columns 6 and 7 provide the 
case-mix index and associated case-mix adjusted component rate, 
respectively, for the relevant SLP group. Column 8 provides the nursing 
case-mix group (CMG) that is connected with a given PDPM HIPPS 
character. For example, if the patient qualified for the nursing group 
CBC1, then the third character in the patient's HIPPS code would be a 
``P.'' Columns 9 and 10 provide the case-mix index and associated case-
mix adjusted component rate, respectively, for the relevant nursing 
group. Finally, columns 11 and 12 provide the case-mix index and 
associated case-mix adjusted component rate, respectively, for the 
relevant NTA group. Tables 6 and 7 do not reflect adjustments which may 
be made to the SNF PPS rates as a result of either the SNF QRP, 
discussed in section VI.B. of this proposed rule, or the SNF VBP 
program, discussed in sections III.B.5. and VI.C. of this proposed 
rule, or other adjustments, such as the variable per diem adjustment. 
Further, we use the revised OMB delineations adopted in the FY 2015 SNF 
PPS final rule (79 FR 45632, 45634), with updates as reflected in OMB 
Bulletin Nos, 15-01 and 17-01, to identify a facility's urban or rural 
status for the purpose of determining which set of rate tables would 
apply to the facility.
 BILLING CODE 4120-01-P

[[Page 17627]]

[GRAPHIC] [TIFF OMITTED] TP25AP19.004


[[Page 17628]]


[GRAPHIC] [TIFF OMITTED] TP25AP19.005

 BILLING CODE 4120-01-C

D. Wage Index Adjustment

    Section 1888(e)(4)(G)(ii) of the Act requires that we adjust the 
federal rates to account for differences in area wage levels, using a 
wage index that the Secretary determines appropriate. Since the 
inception of the SNF PPS, we have used hospital inpatient wage data in 
developing a wage index to be applied to SNFs. We propose to continue 
this practice for FY 2020, as we continue to believe that in the 
absence of SNF-specific wage data, using the hospital inpatient wage 
index data is appropriate and reasonable for the SNF PPS. As explained 
in the update notice for FY 2005 (69 FR 45786), the SNF PPS does not 
use the hospital area wage index's occupational mix adjustment, as this 
adjustment serves specifically to define the occupational categories 
more clearly in a hospital setting; moreover, the collection of the 
occupational wage data also excludes any wage data related to SNFs. 
Therefore, we believe that using the updated wage data exclusive of the 
occupational mix adjustment continues to be appropriate for SNF 
payments. As in previous years, we would continue to use the pre-
reclassified IPPS hospital wage data, unadjusted for occupational mix 
and the rural floor, as the basis for the SNF PPS wage index. For FY 
2020, the updated wage data are for hospital cost reporting periods 
beginning on or after October 1, 2015 and before October 1, 2016 (FY 
2016 cost report data).
    We note that section 315 of the Medicare, Medicaid, and SCHIP 
Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-
554, enacted on December 21, 2000) authorized us to establish a 
geographic reclassification procedure that is specific to SNFs, but 
only after collecting the data necessary to establish a SNF PPS wage 
index that is based on wage data from nursing homes. However, to date, 
this has proven to be unfeasible due to the volatility of existing SNF 
wage data and the significant amount of resources that would be 
required to improve the quality of that data. More specifically, 
auditing all SNF cost reports, similar to the process used to audit 
inpatient hospital cost reports for purposes of the Inpatient 
Prospective Payment System (IPPS) wage index, would place a burden on 
providers in terms of recordkeeping and completion of the cost report 
worksheet. As discussed in greater detail later in this section, 
adopting such an approach would require a significant commitment of 
resources by CMS and the Medicare Administrative Contractors, 
potentially far in excess of those required under the IPPS given that 
there are nearly five times as many SNFs as there are inpatient 
hospitals. Therefore, while we continue to believe that the development 
of such an audit process could improve SNF cost reports in such a 
manner as to permit us to establish a SNF-specific wage index, we do 
not regard an undertaking of this magnitude as being feasible within 
the current level of programmatic resources.
    In addition, we propose to continue to use the same methodology 
discussed in the SNF PPS final rule for FY 2008 (72 FR 43423) to 
address those geographic areas in which there are no hospitals, and 
thus, no hospital wage index data on which to base the calculation of 
the

[[Page 17629]]

FY 2019 SNF PPS wage index. For rural geographic areas that do not have 
hospitals, and therefore, lack hospital wage data on which to base an 
area wage adjustment, we would use the average wage index from all 
contiguous Core-Based Statistical Areas (CBSAs) as a reasonable proxy. 
For FY 2020, there are no rural geographic areas that do not have 
hospitals, and thus, this methodology would not be applied. For rural 
Puerto Rico, we would not apply this methodology due to the distinct 
economic circumstances that exist there (for example, due to the close 
proximity to one another of almost all of Puerto Rico's various urban 
and non-urban areas, this methodology would produce a wage index for 
rural Puerto Rico that is higher than that in half of its urban areas); 
instead, we would continue to use the most recent wage index previously 
available for that area. For urban areas without specific hospital wage 
index data, we would use the average wage indexes of all of the urban 
areas within the state to serve as a reasonable proxy for the wage 
index of that urban CBSA. For FY 2020, the only urban area without wage 
index data available is CBSA 25980, Hinesville-Fort Stewart, GA. The 
final wage index applicable to FY 2020 is set forth in Tables A and B 
available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html.
    In the SNF PPS final rule for FY 2006 (70 FR 45026, August 4, 
2005), we adopted the changes discussed in OMB Bulletin No. 03-04 (June 
6, 2003), which announced revised definitions for MSAs and the creation 
of micropolitan statistical areas and combined statistical areas. In 
adopting the CBSA geographic designations, we provided for a 1-year 
transition in FY 2006 with a blended wage index for all providers. For 
FY 2006, the wage index for each provider consisted of a blend of 50 
percent of the FY 2006 MSA-based wage index and 50 percent of the FY 
2006 CBSA-based wage index (both using FY 2002 hospital data). We 
referred to the blended wage index as the FY 2006 SNF PPS transition 
wage index. As discussed in the SNF PPS final rule for FY 2006 (70 FR 
45041), since the expiration of this 1-year transition on September 30, 
2006, we have used the full CBSA-based wage index values.
    In the FY 2015 SNF PPS final rule (79 FR 45644 through 45646), we 
finalized changes to the SNF PPS wage index based on the newest OMB 
delineations, as described in OMB Bulletin No. 13-01, beginning in FY 
2015, including a 1-year transition with a blended wage index for FY 
2015. OMB Bulletin No. 13-01 established revised delineations for 
Metropolitan Statistical Areas, Micropolitan Statistical Areas, and 
Combined Statistical Areas in the United States and Puerto Rico based 
on the 2010 Census, and provided guidance on the use of the 
delineations of these statistical areas using standards published on 
June 28, 2010 in the Federal Register (75 FR 37246 through 37252). 
Subsequently, on July 15, 2015, OMB issued OMB Bulletin No. 15-01, 
which provides minor updates to and supersedes OMB Bulletin No. 13-01 
that was issued on February 28, 2013. The attachment to OMB Bulletin 
No. 15-01 provides detailed information on the update to statistical 
areas since February 28, 2013. The updates provided in OMB Bulletin No. 
15-01 are based on the application of the 2010 Standards for 
Delineating Metropolitan and Micropolitan Statistical Areas to Census 
Bureau population estimates for July 1, 2012 and July 1, 2013. In 
addition, on August 15, 2017, OMB issued Bulletin No. 17-01 which 
announced a new urban CBSA, Twin Falls, Idaho (CBSA 46300). As we 
previously stated in the FY 2008 SNF PPS proposed and final rules (72 
FR 25538 through 25539, and 72 FR 43423), we wish to note that this and 
all subsequent SNF PPS rules and notices are considered to incorporate 
any updates and revisions set forth in the most recent OMB bulletin 
that applies to the hospital wage data used to determine the current 
SNF PPS wage index.
    Once calculated, we would apply the wage index adjustment to the 
labor-related portion of the federal rate. Each year, we calculate a 
revised labor-related share, based on the relative importance of labor-
related cost categories (that is, those cost categories that are labor-
intensive and vary with the local labor market) in the input price 
index. In the SNF PPS final rule for FY 2018 (82 FR 36548 through 
36566), we finalized a proposal to revise the labor-related share to 
reflect the relative importance of the 2014-based SNF market basket 
cost weights for the following cost categories: Wages and Salaries; 
Employee Benefits; Professional Fees: Labor-Related; Administrative and 
Facilities Support Services; Installation, Maintenance, and Repair 
Services; All Other: Labor-Related Services; and a proportion of 
Capital-Related expenses.
    We calculate the labor-related relative importance from the SNF 
market basket, and it approximates the labor-related portion of the 
total costs after taking into account historical and projected price 
changes between the base year and FY 2020. The price proxies that move 
the different cost categories in the market basket do not necessarily 
change at the same rate, and the relative importance captures these 
changes. Accordingly, the relative importance figure more closely 
reflects the cost share weights for FY 2020 than the base year weights 
from the SNF market basket.
    We calculate the labor-related relative importance for FY 2020 in 
four steps. First, we compute the FY 2020 price index level for the 
total market basket and each cost category of the market basket. 
Second, we calculate a ratio for each cost category by dividing the FY 
2020 price index level for that cost category by the total market 
basket price index level. Third, we determine the FY 2020 relative 
importance for each cost category by multiplying this ratio by the base 
year (2014) weight. Finally, we add the FY 2020 relative importance for 
each of the labor-related cost categories (Wages and Salaries, Employee 
Benefits, Professional Fees: Labor-Related, Administrative and 
Facilities Support Services, Installation, Maintenance, and Repair 
Services, All Other: Labor-related services, and a portion of Capital-
Related expenses) to produce the FY 2020 labor-related relative 
importance. Table 8 summarizes the proposed labor-related share for FY 
2020, based on IGI's first quarter 2019 forecast with historical data 
through fourth quarter 2018, compared to the labor-related share that 
was used for the FY 2019 SNF PPS final rule.

[[Page 17630]]



     Table 8--Labor-Related Relative Importance, FY 2019 and FY 2020
------------------------------------------------------------------------
                                         Relative           Relative
                                    importance, labor- importance, labor-
                                     related, FY 2019   related, FY 2020
                                    18:2 forecast \1\  19:1 forecast \2\
------------------------------------------------------------------------
Wages and salaries................               50.2               50.6
Employee benefits.................               10.1               10.0
Professional Fees: Labor-Related..                3.7                3.7
Administrative and facilities                     0.5                0.5
 support services.................
Installation, Maintenance and                     0.6                0.6
 Repair Services..................
All Other: Labor Related Services.                2.5                2.5
Capital-related (.391)............                2.9                2.9
                                   -------------------------------------
    Total.........................               70.5               70.8
------------------------------------------------------------------------
\1\ Published in the Federal Register; based on second quarter 2018 IGI
  forecast.
\2\ Based on first quarter 2019 IGI forecast, with historical data
  through fourth quarter 2018.

    In order to calculate the labor portion of the case-mix adjusted 
per diem rate, one would multiply the total case-mix adjusted per diem 
rate, which is the sum of all five case-mix adjusted components into 
which a patient classifies, and the non-case-mix component rate, by the 
FY 2020 labor-related share percentage provided in Table 8. The 
remaining portion of the rate would be the non-labor portion. In prior 
years, we have included tables which provide the case-mix adjusted RUG-
IV rates, by RUG-IV group, broken out by total rate, labor portion and 
non-labor portion, such as Table 9 of the FY 2019 SNF PPS final rule 
(83 FR 39175). However, under PDPM, as the total rate is calculated as 
a combination of six different component rates, five of which are case-
mix adjusted, and given the sheer volume of possible combinations of 
these five case-mix adjusted components, it is not feasible to provide 
tables similar to those that have existed in prior rulemaking.
    Therefore, to aid stakeholders in understanding the effect of the 
wage index on the calculation of the SNF per diem rate, we have 
included a revised hypothetical rate calculation in Table 9.
    Section 1888(e)(4)(G)(ii) of the Act also requires that we apply 
this wage index in a manner that does not result in aggregate payments 
under the SNF PPS that are greater or less than would otherwise be made 
if the wage adjustment had not been made. For FY 2020 (federal rates 
effective October 1, 2019), we would apply an adjustment to fulfill the 
budget neutrality requirement. We would meet this requirement by 
multiplying each of the components of the unadjusted federal rates by a 
budget neutrality factor equal to the ratio of the weighted average 
wage adjustment factor for FY 2019 to the weighted average wage 
adjustment factor for FY 2020. For this calculation, we would use the 
same FY 2018 claims utilization data for both the numerator and 
denominator of this ratio. We define the wage adjustment factor used in 
this calculation as the labor share of the rate component multiplied by 
the wage index plus the non-labor share of the rate component. The 
proposed budget neutrality factor for FY 2020 would be 1.0060.

E. Wage Index Comment Solicitation

    As discussed above, historically, we have calculated the SNF PPS 
wage index values using unadjusted wage index values from another 
provider setting. Stakeholders have frequently commented on certain 
aspects of the SNF PPS wage index values and their impact on payments. 
We are soliciting comments on concerns stakeholders may have regarding 
the wage index used to adjust SNF PPS payments and suggestions for 
possible updates and improvements to the geographic adjustment of SNF 
PPS payments.

F. SNF Value-Based Purchasing Program

    Beginning with payment for services furnished on October 1, 2018, 
section 1888(h) of the Act requires the Secretary to reduce the 
adjusted Federal per diem rate determined under section 1888(e)(4)(G) 
of the Act otherwise applicable to a SNF for services furnished during 
a fiscal year by 2 percent, and to adjust the resulting rate for a SNF 
by the value-based incentive payment amount earned by the SNF based on 
the SNF's performance score for that fiscal year under the SNF VBP 
Program. To implement these requirements, we finalized in the FY 2019 
SNF PPS final rule the addition of Sec.  413.337(f) to our regulations 
(83 FR 39178).
    Please see section VI.B. of this proposed rule for a discussion of 
our proposals for the SNF VBP Program.

G. Adjusted Rate Computation Example

    The following series of tables provides an example of how payment 
would be calculated during FY 2020 under PDPM for a hypothetical 30 day 
SNF stay, involving the hypothetical SNF XYZ, located in Frederick, MD 
(Urban CBSA 43524), for a hypothetical patient who is classified into 
such groups that the patient's HIPPS code is NHNC1. Table 9 shows the 
adjustments made to the federal per diem rates (prior to application of 
any adjustments under the SNF QRP and SNF VBP programs as discussed 
above) to compute the provider's case-mix adjusted per diem rate for FY 
2020, based on the patient's PDPM classification, as well as how the 
VPD adjustment factor affects calculation of the per diem rate for a 
given day of the stay. Table 10 shows the adjustments made to the case-
mix adjusted per diem rate from Table 9 to account for the provider's 
wage index. The wage index used in this example is based on the FY 2020 
SNF PPS wage index that appears in Table A available on the CMS website 
at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/WageIndex.html. Finally, Table 11 provides the case-mix and wage index 
adjusted per-diem rate for this patient for each day of the 30-day 
stay, as well as the total payment for this stay. Table 11 also 
includes the variable per diem (VPD) adjustment factors for each day of 
the patient's stay, to clarify why the patient's per diem rate changes 
for certain days of the stay. As illustrated in Table 11, SNF XYZ's 
total PPS payment for this particular patient's stay would equal 
$19,992.80.

[[Page 17631]]



                            Table 9--PDPM Case-Mix Adjusted Rate Computation Example
                                           [Per diem rate calculation]
----------------------------------------------------------------------------------------------------------------
                                                                                  VPD adjustment  VPD adjustment
               Component                     Component group      Component rate      factor           rate
----------------------------------------------------------------------------------------------------------------
PT....................................  TN......................          $90.52            1.00          $90.52
OT....................................  TN......................           85.40            1.00           85.40
SLP...................................  SH......................           65.29  ..............           65.29
Nursing...............................  CBC2....................          165.29  ..............          165.29
NTA...................................  NC......................          148.03            3.00          444.09
Non-Case-Mix..........................  ........................           95.48  ..............           95.48
                                                                 -----------------------------------------------
    Total PDPM Case-Mix Adj. Per Diem.  ........................  ..............  ..............          946.07
----------------------------------------------------------------------------------------------------------------


                                                 Table 10--Wage Index Adjusted Rate Computation Example
                                                        [PDPM wage index adjustment calculation]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     PDPM case-mix                                                                        Total case mix
                    HIPPS code                        adjusted per    Labor portion      Wage index       Wage index       Non-labor      and wage index
                                                          diem                                          adjusted rate       portion         adj. rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
NHNC1.............................................         $946.07          $669.82           0.9757          $653.54          $276.25          $929.79
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                   Table 11--Adjusted Rate Computation Example
----------------------------------------------------------------------------------------------------------------
                                                                                                   Case mix and
                                                                      NTA VPD        PT/OT VPD      wage index
                           Day of stay                              adjustment      adjustment     adjusted per
                                                                      factor          factor         diem rate
----------------------------------------------------------------------------------------------------------------
1...............................................................             3.0             1.0         $929.79
2...............................................................             3.0             1.0          929.79
3...............................................................             3.0             1.0          929.79
4...............................................................             1.0             1.0          638.83
5...............................................................             1.0             1.0          638.83
6...............................................................             1.0             1.0          638.83
7...............................................................             1.0             1.0          638.83
8...............................................................             1.0             1.0          638.83
9...............................................................             1.0             1.0          638.83
10..............................................................             1.0             1.0          638.83
11..............................................................             1.0             1.0          638.83
12..............................................................             1.0             1.0          638.83
13..............................................................             1.0             1.0          638.83
14..............................................................             1.0             1.0          638.83
15..............................................................             1.0             1.0          638.83
16..............................................................             1.0             1.0          638.83
17..............................................................             1.0             1.0          638.83
18..............................................................             1.0             1.0          638.83
19..............................................................             1.0             1.0          638.83
20..............................................................             1.0             1.0          638.83
21..............................................................             1.0            0.98          635.37
22..............................................................             1.0            0.98          635.37
23..............................................................             1.0            0.98          635.37
24..............................................................             1.0            0.98          635.37
25..............................................................             1.0            0.98          635.37
26..............................................................             1.0            0.98          635.37
27..............................................................             1.0            0.98          635.37
28..............................................................             1.0            0.96          631.91
29..............................................................             1.0            0.96          631.91
30..............................................................             1.0            0.96          631.91
                                                                 -----------------------------------------------
    Total Payment...............................................  ..............  ..............       19,992.80
----------------------------------------------------------------------------------------------------------------

IV. Additional Aspects of the SNF PPS

A. SNF Level of Care--Administrative Presumption

    The establishment of the SNF PPS did not change Medicare's 
fundamental requirements for SNF coverage. However, because the case-
mix classification is based, in part, on the beneficiary's need for 
skilled nursing care and therapy, we have attempted, where possible, to 
coordinate claims review procedures with the existing resident 
assessment process and case-mix classification system discussed in 
section III.C. of this proposed rule. This

[[Page 17632]]

approach includes an administrative presumption that utilizes a 
beneficiary's correct assignment, at the outset of the SNF stay, to one 
of the case-mix classifiers designated for this purpose to assist in 
making certain SNF level of care determinations.
    In accordance with the regulations at Sec.  413.345, we include in 
each update of the federal payment rates in the Federal Register a 
discussion of the resident classification system that provides the 
basis for case-mix adjustment. Under that discussion, we designate 
those specific classifiers under the case-mix classification system 
that represent the required SNF level of care, as provided in Sec.  
409.30. This designation reflects an administrative presumption that 
those beneficiaries who are correctly assigned one of the designated 
case-mix classifiers on the 5-day Medicare-required assessment are 
automatically classified as meeting the SNF level of care definition up 
to and including the assessment reference date (ARD) for that 
assessment.
    A beneficiary who does not qualify for the presumption is not 
automatically classified as either meeting or not meeting the level of 
care definition, but instead receives an individual determination on 
this point using the existing administrative criteria. This presumption 
recognizes the strong likelihood that those beneficiaries who are 
assigned one of the designated case-mix classifiers during the 
immediate post-hospital period would require a covered level of care, 
which would be less likely for other beneficiaries.
    In the July 30, 1999 final rule (64 FR 41670), we indicated that we 
would announce any changes to the guidelines for Medicare level of care 
determinations related to modifications in the case-mix classification 
structure. The FY 2018 final rule (82 FR 36544) further specified that 
we would henceforth disseminate the standard description of the 
administrative presumption's designated groups via the SNF PPS website 
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/index.html (where such designations appear in the paragraph 
entitled ``Case Mix Adjustment''), and would publish such designations 
in rulemaking only to the extent that we actually intend to make 
changes in them. Under that approach, the set of case-mix classifiers 
designated for this purpose under PDPM was finalized in the FY 2019 SNF 
PPS final rule (83 FR 39253) and is posted on the SNF PPS website 
(https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/index.html), in the paragraph entitled ``Case Mix Adjustment.''
    However, we note that this administrative presumption policy does 
not supersede the SNF's responsibility to ensure that its decisions 
relating to level of care are appropriate and timely, including a 
review to confirm that any services prompting the assignment of one of 
the designated case-mix classifiers (which, in turn, serves to trigger 
the administrative presumption) are themselves medically necessary. As 
we explained in the FY 2000 SNF PPS final rule (64 FR 41667), the 
administrative presumption is itself rebuttable in those individual 
cases in which the services actually received by the resident do not 
meet the basic statutory criterion of being reasonable and necessary to 
diagnose or treat a beneficiary's condition (according to section 
1862(a)(1) of the Act). Accordingly, the presumption would not apply, 
for example, in those situations where the sole classifier that 
triggers the presumption is itself assigned through the receipt of 
services that are subsequently determined to be not reasonable and 
necessary. Moreover, we want to stress the importance of careful 
monitoring for changes in each patient's condition to determine the 
continuing need for Part A SNF benefits after the ARD of the 5-day 
assessment. Finally, regarding the new set of case-mix classifiers 
designated under the PDPM for this purpose, we noted in the FY 2019 SNF 
PPS final rule (83 FR 39253, August 8, 2018) our intent ``. . . to 
review the new designations going forward and make further adjustments 
over time as we gain actual operating experience under the new 
classification model.'' Accordingly, to the extent that it may become 
evident in actual practice that these new criteria are not accurately 
performing their intended role (for example, by capturing cases that do 
not actually require an SNF level of care), we would propose 
appropriate adjustments to correct them.

B. Consolidated Billing

    Sections 1842(b)(6)(E) and 1862(a)(18) of the Act (as added by 
section 4432(b) of the BBA 1997) require a SNF to submit consolidated 
Medicare bills to its Medicare Administrative Contractor (MAC) for 
almost all of the services that its residents receive during the course 
of a covered Part A stay. In addition, section 1862(a)(18) of the Act 
places the responsibility with the SNF for billing Medicare for 
physical therapy, occupational therapy, and speech-language pathology 
services that the resident receives during a noncovered stay. Section 
1888(e)(2)(A) of the Act excludes a small list of services from the 
consolidated billing provision (primarily those services furnished by 
physicians and certain other types of practitioners), which remain 
separately billable under Part B when furnished to a SNF's Part A 
resident. These excluded service categories are discussed in greater 
detail in section V.B.2. of the May 12, 1998 interim final rule (63 FR 
26295 through 26297).
    A detailed discussion of the legislative history of the 
consolidated billing provision is available on the SNF PPS website at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Legislative_History_2018-10-01.pdf. In particular, section 
103 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act 
of 1999 (BBRA, Pub. L. 106-113, enacted on November 29, 1999) amended 
section 1888(e)(2)(A) of the Act by further excluding a number of 
individual high-cost, low probability services, identified by 
Healthcare Common Procedure Coding System (HCPCS) codes, within several 
broader categories (chemotherapy items, chemotherapy administration 
services, radioisotope services, and customized prosthetic devices) 
that otherwise remained subject to the provision. We discuss this BBRA 
amendment in greater detail in the SNF PPS proposed and final rules for 
FY 2001 (65 FR 19231 through 19232, April 10, 2000, and 65 FR 46790 
through 46795, July 31, 2000), as well as in Program Memorandum AB-00-
18 (Change Request #1070), issued March 2000, which is available online 
at www.cms.gov/transmittals/downloads/ab001860.pdf.
    As explained in the FY 2001 proposed rule (65 FR 19232), the 
amendments enacted in section 103 of the BBRA not only identified for 
exclusion from this provision a number of particular service codes 
within four specified categories (that is, chemotherapy items, 
chemotherapy administration services, radioisotope services, and 
customized prosthetic devices), but also gave the Secretary the 
authority to designate additional, individual services for exclusion 
within each of the specified service categories. In the proposed rule 
for FY 2001, we also noted that the BBRA Conference report (H.R. Rep. 
No. 106-479 at 854 (1999) (Conf. Rep.)) characterizes the individual 
services that this legislation targets for exclusion as high-cost, low 
probability events that could have devastating financial impacts 
because their costs far exceed the payment SNFs receive under the PPS. 
According to the conferees, section 103(a) of the BBRA is an attempt to 
exclude from the PPS certain services

[[Page 17633]]

and costly items that are provided infrequently in SNFs. By contrast, 
the amendments enacted in section 103 of the BBRA do not designate for 
exclusion any of the remaining services within those four categories 
(thus, leaving all of those services subject to SNF consolidated 
billing), because they are relatively inexpensive and are furnished 
routinely in SNFs.
    As we further explained in the final rule for FY 2001 (65 FR 
46790), and as is consistent with our longstanding policy, any 
additional service codes that we might designate for exclusion under 
our discretionary authority must meet the same statutory criteria used 
in identifying the original codes excluded from consolidated billing 
under section 103(a) of the BBRA: they must fall within one of the four 
service categories specified in the BBRA; and they also must meet the 
same standards of high cost and low probability in the SNF setting, as 
discussed in the BBRA Conference report. Accordingly, we characterized 
this statutory authority to identify additional service codes for 
exclusion as essentially affording the flexibility to revise the list 
of excluded codes in response to changes of major significance that may 
occur over time (for example, the development of new medical 
technologies or other advances in the state of medical practice) (65 FR 
46791). In this proposed rule, we specifically invite public comments 
identifying HCPCS codes in any of these four service categories 
(chemotherapy items, chemotherapy administration services, radioisotope 
services, and customized prosthetic devices) representing recent 
medical advances that might meet our criteria for exclusion from SNF 
consolidated billing. We may consider excluding a particular service if 
it meets our criteria for exclusion as specified above. Commenters 
should identify in their comments the specific HCPCS code that is 
associated with the service in question, as well as their rationale for 
requesting that the identified HCPCS code(s) be excluded.
    We note that the original BBRA amendment (as well as the 
implementing regulations) identified a set of excluded services by 
means of specifying HCPCS codes that were in effect as of a particular 
date (in that case, as of July 1, 1999). Identifying the excluded 
services in this manner made it possible for us to utilize program 
issuances as the vehicle for accomplishing routine updates of the 
excluded codes, to reflect any minor revisions that might subsequently 
occur in the coding system itself (for example, the assignment of a 
different code number to the same service). Accordingly, in the event 
that we identify through the current rulemaking cycle any new services 
that would actually represent a substantive change in the scope of the 
exclusions from SNF consolidated billing, we would identify these 
additional excluded services by means of the HCPCS codes that are in 
effect as of a specific date (in this case, as of October 1, 2019). By 
making any new exclusions in this manner, we could similarly accomplish 
routine future updates of these additional codes through the issuance 
of program instructions.

C. Payment for SNF-Level Swing-Bed Services

    Section 1883 of the Act permits certain small, rural hospitals to 
enter into a Medicare swing-bed agreement, under which the hospital can 
use its beds to provide either acute- or SNF-level care, as needed. For 
critical access hospitals (CAHs), Part A pays on a reasonable cost 
basis for SNF-level services furnished under a swing-bed agreement. 
However, in accordance with section 1888(e)(7) of the Act, SNF-level 
services furnished by non-CAH rural hospitals are paid under the SNF 
PPS, effective with cost reporting periods beginning on or after July 
1, 2002. As explained in the FY 2002 final rule (66 FR 39562), this 
effective date is consistent with the statutory provision to integrate 
swing-bed rural hospitals into the SNF PPS by the end of the transition 
period, June 30, 2002.
    Accordingly, all non-CAH swing-bed rural hospitals have now come 
under the SNF PPS. Therefore, all rates and wage indexes outlined in 
earlier sections of this final rule for the SNF PPS also apply to all 
non-CAH swing-bed rural hospitals. As finalized in the FY 2010 SNF PPS 
final rule (74 FR 40356 through 40357), effective October 1, 2010, non-
CAH swing-bed rural hospitals are required to complete an MDS 3.0 
swing-bed assessment which is limited to the required demographic, 
payment, and quality items. As discussed in the FY 2019 SNF PPS final 
rule (83 FR 39235), revisions were made to the swing bed assessment in 
order to support implementation of PDPM, effective October 1, 2019. A 
discussion of the assessment schedule and the MDS effective beginning 
FY 2020 appears in the FY 2019 SNF PPS final rule (83 FR 39229 through 
39237). The latest changes in the MDS for swing-bed rural hospitals 
appear on the SNF PPS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/index.html.

V. Issues Relating to PDPM Implementation

A. Revised Group Therapy Definition

    As set forth in the FY 2019 SNF PPS final rule (83 FR 39162), 
effective October 1, 2019 under the PDPM, patients will be classified 
into case-mix groups under each therapy component based on patient 
characteristics rather than using the volume of therapy services 
furnished to the patient as the basis for classification. Additionally, 
as discussed in the FY 2019 SNF PPS final rule (83 FR 39237 through 
39243), we finalized a combined limit on concurrent and group therapy 
furnished to a patient, specifically that, for each therapy discipline, 
no more than 25 percent of the therapy services furnished to a patient 
in a covered Medicare Part A stay may be in a group or concurrent 
setting. Given these policy changes relating to therapy classification 
and therapy provision under the PDPM, as well as recent efforts to 
increase standardization across PAC settings, we believed it was 
appropriate to evaluate other policies associated with therapy under 
PDPM to determine if other policies should be revised as well.
    In the FY 2012 SNF PPS final rule (76 FR 48511 through 48517), we 
finalized changes relating to the definition of group therapy and 
payment of group therapy services, specifically to define group therapy 
as the practice of one therapist or therapy assistant treating four 
patients at the same time while the patients are performing either the 
same or similar activities. In the FY 2012 SNF PPS final rule (76 FR 
48511), we noted that, using our STRIVE data as a baseline, we 
identified under RUG-IV two significant changes in provider behavior 
related to the provision of therapy services to Medicare beneficiaries 
in SNFs. First, we saw a major decrease in the amount of concurrent 
therapy (that is therapy provided to two patients by one therapist or 
therapy assistant doing different activities) performed in SNFs, the 
minutes for which are divided between the two concurrent therapy 
participants when determining the patient's appropriate RUG 
classification. At the same time, we found a significant increase in 
the amount of group therapy services, which were not subject to the 
allocation requirement. Given this increase in group therapy services, 
we expressed concern that the method for reporting group therapy on the 
MDS created an inappropriate payment incentive to perform the group 
therapy in place of individual therapy, because the method of reporting 
group therapy

[[Page 17634]]

time did not require allocation among patients.
    As we stated in the FY 2012 SNF PPS final rule (76 FR 48511), 
because in group therapy, patients are performing similar activities, 
in contrast to concurrent therapy, group therapy gives patients the 
opportunity to benefit from each other's therapy regimen by observing 
and interacting with one another and applying the lessons learned from 
others to one's own therapy program in order to progress. At that time, 
we stated that large groups, such as those of five or more 
participants, can make it difficult for the participants to engage with 
one another over the course of the session. In addition, we have long 
believed that individual therapists could not adequately supervise 
large groups, and since the inception of the SNF PPS in July 1998, we 
have capped the number of residents at four. Furthermore, we believed 
that groups of fewer than four participants did not maximize the group 
therapy benefit for the participants. As we stated in the FY 2012 final 
rule (76 FR 48511), we believed that in groups of two or three 
participants, the opportunities for patients in the group to interact 
and learn from each other are significantly diminished given the small 
size of the group. Thus, we revised the definition of group therapy to 
require a group size for the SNF setting of exactly four patients, 
which we believed was the size that permits the therapy participants to 
derive the maximum benefit from the group therapy setting.
    Since that time, we have monitored group therapy utilization and 
found that, as discussed in the FY 2019 SNF PPS final rule (83 FR 39237 
through 39238), group therapy represents a very small proportion of 
therapy provided to SNF patients. Further, as discussed in the FY 2019 
SNF PPS final rule (83 FR 39240 through 39241), some commenters 
suggested that we revise the definition of group therapy to include two 
to six participants doing the same or similar activities, as this would 
better align with the Inpatient Rehabilitation Facility (IRF) setting 
and allow increased flexibility so that patients in smaller SNFs, 
presumably where a group of exactly four patients may be difficult to 
attain, could utilize and benefit from group therapy. In our response 
to these comments, in the FY 2019 SNF PPS final rule (83 FR 39241), we 
stated that we may consider changing the definition of group therapy in 
future rulemaking. In the past we stated our concern that a group that 
consisted of more than 4 participants would not allow for adequate 
supervision of each participant as well as cause difficulty for 
participants to engage with one another in the most effective way. 
Conversely, we maintained that a group of fewer than 4 participants 
would not allow for effective interaction to best achieve the goals of 
a group. For these reasons, we defined group therapy as exactly 4 
participants. However, based on our review of the use of group therapy 
in the IRF and outpatient settings where the definition of group 
therapy is less restrictive than the current definition under the SNF 
PPS, we have found that therapists do seem capable of managing groups 
of various sizes. Based on this review, we believe therapists have the 
clinical judgment to determine whether groups of different sizes would 
clinically benefit their patients, which they should be able to 
demonstrate with adequate documentation. Patients can often benefit 
from the psycho-social aspect of groups, and in some situations, a 
group of six participants is not too large to provide that benefit to 
participants. For example, a cooking activity which will provide very 
functional therapy for patients planning to return home can be done in 
a group of six that will enhance the patient's psycho-social experience 
in the SNF. Alternatively, a group of 2-3 patients can be clinically 
useful for certain patients as well. For example, a group of 2-3 
patients who have pragmatic language difficulties following a stroke or 
head injury could very well benefit from a small communication group to 
work on the social aspects of language together without the concern of 
distraction that a larger group might cause. Thus, while we continue to 
maintain minimal concerns that some groups may be either too small or 
too large to allow for effective interaction, we believe that the 
potential clinical benefits of various size groups outweigh our 
concerns, and that it would be appropriate to allow therapists greater 
flexibility to perform therapy in groups of different sizes.
    In light of our discussion above and the comments in the FY 2019 
SNF PPS final rule, and to align the SNF PPS more closely with other 
settings, in this proposed rule, we propose to adopt a new definition 
of group therapy for use under PDPM, effective October 1, 2019, as 
further discussed below.
    In an effort to support CMS' cross-setting initiatives under the 
IMPACT Act and Meaningful Measures Initiative, we have looked at ways 
to align the definition of group therapy used under the SNF PPS more 
closely with the definitions used within the outpatient setting covered 
under Medicare Part B and under the IRF PPS, as this type of 
standardization would reduce administrative burden on providers by 
utilizing the same or similar definitions across settings. For group 
therapy in the outpatient setting, the Medicare Benefit Policy Manual, 
Chapter 15, Section 230 states that contractors pay for outpatient 
physical therapy services (which includes outpatient speech-language 
pathology services) and outpatient occupational therapy services 
provided simultaneously to two or more individuals by a practitioner as 
group therapy services (CPT code 97150). This manual section further 
states that the individuals can be, but need not be, performing the 
same activity. In addition, this section states that the physician or 
therapist involved in group therapy services must be in constant 
attendance, but one-on-one patient contact is not required. Under the 
IRF PPS, the definition of group therapy (found in Section 2 of the IRF 
PAI Training Manual, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/IRFPAI-1_5-2_0.zip) is 
the provision of therapy services by one licensed or certified 
therapist (or licensed therapy assistant, under the appropriate 
direction of a licensed or certified therapist) treating two to six 
patients at the same time who are performing the same or similar 
activities.
    We considered using the same definition as used in the outpatient 
setting covered under Medicare Part B, which is two or more patients 
performing either the same or different activity, as opposed to the IRF 
definition of two to six patients performing the same or similar 
activities. However, given the greater degree of similarity between the 
IRF and SNF settings in terms of the intensity of therapy and patient 
acuity, we believe that the IRF PPS definition would be more 
appropriate in the SNF setting.
    Accordingly, for the reasons discussed previously, we are proposing 
to define group therapy in the SNF Part A setting as a qualified 
rehabilitation therapist or therapy assistant treating two to six 
patients at the same time who are performing the same or similar 
activities. We believe this definition would offer therapists more 
clinical flexibility when determining the appropriate number for a 
group, without compromising the therapist's ability to manage the group 
and the patient's ability to interact effectively and benefit from 
group therapy.

[[Page 17635]]

    We continue to believe that individual therapy is the preferred 
mode of therapy provision and offers the most tailored service for 
patients. As we stated in the FY 2012 proposed rule (76 FR 26387), 
while group therapy can play an important role in SNF patient care, 
group therapy is not appropriate for either all patients or for all 
conditions, and is primarily effective as a supplement to individual 
therapy, which we maintain should be considered the primary therapy 
mode and standard of care in therapy services provided to SNF 
residents.
    Additionally, we continue to maintain that when group therapy is 
used in a SNF, therapists must document its use in order to demonstrate 
why it is the most appropriate mode of therapy for the patient who is 
receiving it. As stated in the FY 2012 proposed rule (76 FR 26388) 
regarding group therapy documentation, because group therapy is not 
appropriate for either all patients or all conditions, and in order to 
verify that group therapy is medically necessary and appropriate to the 
needs of each beneficiary, SNFs should include in the patient's plan of 
care an explicit justification for the use of group, rather than 
individual or concurrent, therapy. This description should include, but 
need not be limited to, the specific benefits to that particular 
patient of including the documented type and amount of group therapy; 
that is, how the prescribed type and amount of group therapy will meet 
the patient's needs and assist the patient in reaching the documented 
goals. In addition, we believe that the above documentation is 
necessary to demonstrate that the SNF is providing services to attain 
or maintain the highest practicable physical, mental, and psychosocial 
well-being of each resident in accordance with section 1819(b)(2) of 
the Act.

B. Updating ICD-10 Code Mappings and Lists

    In the FY 2019 SNF PPS final rule (83 FR 39162), we finalized the 
implementation of PDPM, effective October 1, 2019. The PDPM utilizes 
ICD-10 codes in several ways, including to assign patients to clinical 
categories used for categorization in the PT, OT, and SLP components, 
as well as identifying certain comorbidities relevant for 
classification under the SLP and NTA components. The ICD-10 mappings 
and lists that would be used under PDPM, once implemented, are 
available on the PDPM website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html.
    Each year, the ICD-10 Coordination and Maintenance Committee, a 
federal interdepartmental committee that is chaired by representatives 
from the National Center for Health Statistics (NCHS) and by 
representatives from CMS, meets biannually and publishes updates to the 
ICD-10 medical code data sets in June of each year. These changes 
become effective October 1 of the year in which these updates are 
issued by the committee. The ICD-10 Coordination and Maintenance 
Committee also has the ability to make changes to the ICD-10 medical 
code data sets effective on April 1, but has not yet done so.
    As providers are required to follow the most up to date coding 
guidance issued by this committee in accordance with 45 CFR part 162, 
subpart J, it is essential that we be able to update our code mappings 
and lists consistent with the latest coding guidance. Therefore, to 
ensure that the ICD-10 mappings and lists used under PDPM reflect the 
most up to date codes possible, we propose to update any ICD-10 code 
mappings and lists used under PDPM, as well as the SNF GROUPER software 
and other such products related to patient classification and billing, 
through a subregulatory process which would consist of posting updated 
code mappings and lists on the PDPM website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html. More 
specifically, beginning with the updates for FY 2020 (see discussion 
below), nonsubstantive changes to the ICD-10 codes included on the code 
mappings and lists under the PDPM would be applied through the 
subregulatory process described above, and substantive revisions to the 
ICD-10 codes on the code mappings and lists used under the PDPM would 
be proposed and finalized through notice and comment rulemaking.
    Nonsubstantive changes would be limited to those specific changes 
that are necessary to maintain consistency with the most current ICD-10 
medical code data set, which Medicare providers are generally required 
to use. Our intent in applying these nonsubstantive changes through the 
proposed subregulatory process would be to keep the same conditions in 
the PDPM clinical categories and comorbidities lists, but ensure that 
the codes used to identify those conditions are synchronized with the 
most current ICD-10 medical code data set. For example, to the extent 
that the ICD-10-CM Coordination and Maintenance Committee changes an 
ICD-10 code for a comorbid condition on our comorbidities lists into 
one or more codes that provide additional detail, we would update the 
SNF GROUPER software and ICD-10 mappings and lists on the CMS website 
to reflect the new codes through the subregulatory process proposed 
above. By contrast, we would use notice and comment rulemaking to make 
substantive changes to the ICD-10 code mappings and lists under the 
PDPM. For the purposes of this policy, a substantive change would be 
defined simply as any change that does not fall within the definition 
of a nonsubstantive change--that is, changes that go beyond the 
intention of maintaining consistency with the most current ICD-10 
medical code data set. For instance, changes to the assignment of a 
code to a comorbidity list or other changes that amount to changes in 
policy would be substantive changes. Taking the example above, there 
may be situations in which the addition of one or more of these new 
codes to the list of comorbidities may not be appropriate. For example, 
the ICD-10 code for a particular condition is divided into two more 
detailed codes, one of which represents a condition that generally is 
predictive of the costs of care in a SNF and one of which is not. We 
would propose through notice and comment rulemaking to delete the code 
that does not reflect increased costs of care in a SNF from the list of 
comorbidities in the SNF GROUPER software because removing the code 
would constitute a substantive change. We propose to indicate all 
changes to codes in the GROUPER software by posting a complete ICD-10 
mapping table, including new, discontinued, and modified codes, on the 
PDPM website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html. We also propose to report the complete list 
of ICD-10 codes associated with the SNF PDPM clinical categories and 
SLP/NTA comorbidities in the SNF GROUPER documentation, which is also 
posted on the PDPM website. All changes would be included in these 
documents, with substantive changes being included only after being 
finalized through notice and comment rulemaking.
    We believe that the proposed subregulatory update process (by which 
nonsubstantive changes to the ICD-10 code mappings and lists used under 
PDPM as well as the SNF GROUPER software and other such products 
related to patient classification and billing would be posted on the 
CMS websites specified above), is the best way for us to convey 
information about changes to the ICD-10 medical code

[[Page 17636]]

data set that affect the code mappings and lists used under the PDPM. 
We believe the proposed subregulatory process would help ensure 
providers have the most up-to-date information as soon as possible, in 
the clearest and most useful format, as opposed to publishing each 
nonsubstantive change to the ICD-10 codes in a rule after notice and 
comment rulemaking.
    Additionally, the proposed subregulatory process is in alignment 
with similar policies in the SNF PPS and the IRF PPS settings. For 
example, the SNF PPS already uses a subregulatory process to make 
nonsubstantive updates to the list of Healthcare Common Procedure 
Coding System (HCPCS) codes that are subject to the consolidated 
billing (CB) provision of the SNF PPS. We post routine annual updates 
to the lists of codes that are included or excluded from CB on the SNF 
CB website at https://www.cms.gov/Medicare/Billing/SNFConsolidatedBilling/index.html. The new codes identified in each 
update describe the same services that are subject to SNF PPS CB. No 
additional services are added by these routine updates; that is, these 
updates are necessary because of changes to the coding system, not 
because the services subject to SNF CB are being redefined. We believe 
the proposed subregulatory process to update ICD-10 codes associated 
with PDPM clinical categories and comorbidity lists is appropriate 
given that it is consistent with this subregulatory process already in 
use under the SNF PPS to make nonsubstantive coding updates.
    Likewise, the IRF PPS also utilizes processes similar to that 
proposed here. In the FY 2007 IRF PPS final rule (71 FR 48360 through 
48361), we implemented a similar subregulatory updating process for the 
IRF tier comorbidities list, and the FY 2018 IRF PPS final rule (82 FR 
36267 through 36269) established a similar process for updating the 
ICD-10 code lists used for the IRF presumptive compliance methodology. 
Both the IRF tier comorbidities list and the IRF presumptive compliance 
methodology also use ICD-10 codes. Therefore, we believe the 
subregulatory process proposed in this rule is appropriate because it 
is also consistent with processes used in another Medicare setting.
    We are proposing that this subregulatory process for updating the 
ICD-10 codes used under the PDPM would take effect beginning with the 
updates for FY 2020. The proposed ICD-10 code mappings and lists for 
use under the PDPM are available for download from the SNF PPS website 
(https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/PDPM.html). These mappings and lists reflect the adoption of the ICD-10 
Coordination and Maintenance Committee's draft changes to the ICD-10 
medical code data sets, effective October 1, 2018. The version of these 
mappings and lists that is finalized in conjunction with the FY 2020 
SNF PPS final rule would constitute the baseline for any future updates 
to the mappings and lists using the proposed process above.

C. Revisions to the Regulation Text

    Along with our proposed revisions as discussed elsewhere in this 
proposed rule, we are also proposing to make certain revisions to the 
regulations text itself to reflect the revised assessment schedule 
under the PDPM, as finalized in the FY 2019 SNF PPS final rule (83 FR 
39229). Specifically, we propose to revise the prescribed PPS 
assessment schedule as set forth in Sec.  413.343(b), to reflect the 
elimination, upon the conversion from RUG-IV to PDPM on October 1, 
2019, of all scheduled assessments after the initial 5-day, Medicare-
required assessment. We note that even though this assessment is 
commonly referred to as the ``5-day'' assessment (reflecting its 
original 5-day assessment window), an additional 3 grace days have 
always been available beyond that window for its actual completion. 
Further, because those additional 3 grace days will be directly 
incorporated into the assessment window itself effective October 1, 
2019 (as finalized in the FY 2019 SNF PPS final rule (83 FR 39231, 
39232, and 39234)), thus resulting in an overall 8-day assessment 
window, we additionally propose to include a conforming revision in 
Sec.  413.343(b) to make clear that the actual deadline for completing 
this assessment is no later than the 8th day of posthospital SNF care. 
In addition, because under the PDPM, there is only one scheduled 
patient assessment, we also propose to replace the phrase ``patient 
assessments'' in Sec.  413.343(b) with the phrase ``an initial patient 
assessment.'' Accordingly, we propose to revise Sec.  413.343(b) to 
state that the assessment schedule must include performance of an 
initial patient assessment no later than the 8th day of posthospital 
SNF care.
    We further propose to revise the existing language in Sec.  
413.343(b) that additionally requires the completion of ``such other 
assessments that are necessary to account for changes in patient care 
needs,'' to state ``such other interim payment assessments as the SNF 
determines are necessary to account for changes in patient care 
needs.'' As we finalized in the FY 2019 SNF PPS final rule (83 FR 39230 
through 39234), the optional Interim Payment Assessment (IPA) will 
serve as the instrument for conducting assessments under the PDPM that 
the SNF determines are necessary after the completion of the 5-day, 
Medicare-required assessment to address clinical changes throughout a 
SNF stay. We believe that our proposed language is consistent with the 
expectation expressed in the FY 2019 SNF PPS final rule for SNFs ``. . 
. to provide excellent skilled nursing and rehabilitative care and 
continually monitor and document patient status'' (83 FR 39233), and 
makes clear that the SNF's responsibility in this context would include 
recognizing those situations that warrant a decision to complete an IPA 
in order to account appropriately for a change in patient status. 
Finally, to ensure consistency, we also propose to make a conforming 
revision to the regulations text in the introductory paragraph of Sec.  
409.30, so that it would use the same terminology of ``initial patient 
assessment'' as would appear in revised Sec.  413.343(b). Specifically, 
in the introductory paragraph of Sec.  409.30, we would replace the 
phrase ``the 5-day assessment'' with ``the initial patient 
assessment.'' We note that the regulations text in the introductory 
paragraph of Sec.  409.30 would continue to specify that the assessment 
reference date (ARD) for this assessment must occur no later than the 
8th day of posthospital SNF care, consistent with the instructions set 
forth in sections 2.8 and 2.9 of the RAI Version 3.0 Manual.

VI. Other Issues

A. Skilled Nursing Facility (SNF) Quality Reporting Program (QRP)

1. Background
    The Skilled Nursing Facility Quality Reporting Program (SNF QRP) is 
authorized by section 1888(e)(6) of the Act and it applies to 
freestanding SNFs, SNFs affiliated with acute care facilities, and all 
non-CAH swing-bed rural hospitals. Under the SNF QRP, the Secretary 
must reduce by 2 percentage points the annual market basket percentage 
update described in section 1888(e)(5)(B)(i) of the Act applicable to a 
SNF for a fiscal year, after application of section 1888(e)(5)(B)(ii) 
of the Act (the MFP adjustment) and section 1888(e)(5)(B)(iii) of the 
Act, in the case of a SNF that does not submit data in accordance with 
sections 1888(e)(6)(B)(i) of the Act for that fiscal year. For more 
information on the

[[Page 17637]]

requirements we have adopted for the SNF QRP, we refer readers to the 
FY 2016 SNF PPS final rule (80 FR 46427 through 46429), FY 2017 SNF PPS 
final rule (81 FR 52009 through 52010), FY 2018 SNF PPS final rule (82 
FR 36566), and FY 2019 SNF PPS final rule (83 FR 39162 through 39272).
2. General Considerations Used for the Selection of Measures for the 
SNF QRP
    For a detailed discussion of the considerations we historically 
used for the selection of SNF QRP quality, resource use, and other 
measures, we refer readers to the FY 2016 SNF PPS final rule (80 FR 
46429 through 46431).
3. Quality Measures Currently Adopted for the FY 2021 SNF QRP
    The SNF QRP currently has 11 measures for the FY 2021 SNF QRP, 
which are set out in Table 12.

  Table 12--Quality Measures Currently Adopted for the FY 2021 SNF QRP
------------------------------------------------------------------------
            Short name                   Measure name & data source
------------------------------------------------------------------------
             Resident Assessment Instrument Minimum Data Set
------------------------------------------------------------------------
Pressure Ulcer/Injury.............  Changes in Skin Integrity Post-Acute
                                     Care: Pressure Ulcer/Injury.
Application of Falls..............  Application of Percent of Residents
                                     Experiencing One or More Falls with
                                     Major Injury (Long Stay) (NQF
                                     #0674).
Application of Functional           Application of Percent of Long-Term
 Assessment/Care Plan.               Care Hospital (LTCH) Patients with
                                     an Admission and Discharge
                                     Functional Assessment and a Care
                                     Plan That Addresses Function (NQF
                                     #2631).
Change in Mobility Score..........  Application of IRF Functional
                                     Outcome Measure: Change in Mobility
                                     Score for Medical Rehabilitation
                                     Patients (NQF #2634).
Discharge Mobility Score..........  Application of IRF Functional
                                     Outcome Measure: Discharge Mobility
                                     Score for Medical Rehabilitation
                                     Patients (NQF #2636).
Change in Self-Care Score.........  Application of the IRF Functional
                                     Outcome Measure: Change in Self-
                                     Care Score for Medical
                                     Rehabilitation Patients (NQF
                                     #2633).
Discharge Self-Care Score.........  Application of IRF Functional
                                     Outcome Measure: Discharge Self-
                                     Care Score for Medical
                                     Rehabilitation Patients (NQF
                                     #2635).
DRR...............................  Drug Regimen Review Conducted With
                                     Follow-Up for Identified Issues-
                                     Post Acute Care (PAC) Skilled
                                     Nursing Facility (SNF) Quality
                                     Reporting Program (QRP).
------------------------------------------------------------------------
                              Claims-Based
------------------------------------------------------------------------
MSPB SNF..........................  Medicare Spending Per Beneficiary
                                     (MSPB)-Post Acute Care (PAC)
                                     Skilled Nursing Facility (SNF)
                                     Quality Reporting Program (QRP).
DTC...............................  Discharge to Community (DTC)-Post
                                     Acute Care (PAC) Skilled Nursing
                                     Facility (SNF) Quality Reporting
                                     Program (QRP).
PPR...............................  Potentially Preventable 30-Day Post-
                                     Discharge Readmission Measure for
                                     Skilled Nursing Facility (SNF)
                                     Quality Reporting Program (QRP).
------------------------------------------------------------------------

4. SNF QRP Quality Measure Proposals Beginning With the FY 2022 SNF QRP
    In this proposed rule, we are proposing to adopt two process 
measures for the SNF QRP that, as required by section 
1888(e)(6)(B)(i)(II) of the Act, would satisfy section 
1899B(c)(1)(E)(ii) of the Act, which requires that the quality measures 
specified by the Secretary include measures with respect to the quality 
measure domain titled ``Accurately communicating the existence of and 
providing for the transfer of health information and care preferences 
of an individual to the individual, family caregiver of the individual, 
and providers of services furnishing items and services to the 
individual when the individual transitions from a post-acute care (PAC) 
provider to another applicable setting, including a different PAC 
provider, a hospital, a critical access hospital, or the home of the 
individual.'' Given the length of this domain title, hereafter, we will 
refer to this quality measure domain as ``Transfer of Health 
Information.''
    The two measures we are proposing to adopt are: (1) Transfer of 
Health Information to the Provider-Post-Acute Care (PAC); and (2) 
Transfer of Health Information to the Patient-Post-Acute Care (PAC). 
Both of these proposed measures support our Meaningful Measures 
priority of promoting effective communication and coordination of care, 
specifically the Meaningful Measure area of the transfer of health 
information and interoperability.
    In addition to the two measure proposals, we are proposing to 
update the specifications for the Discharge to Community--PAC SNF QRP 
measure to exclude baseline nursing facility (NF) residents from the 
measure.
    We are seeking public comment on each of these proposals.
a. Proposed Transfer of Health Information to the Provider-Post-Acute 
Care (PAC) Measure
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) Measure is a process-based measure that assesses 
whether or not a current reconciled medication list is given to the 
subsequent provider when a patient is discharged or transferred from 
his or her current PAC setting.
(1) Background
    In 2013, 22.3 percent of all acute hospital discharges were 
discharged to PAC settings, including 11 percent who were discharged to 
home under the care of a home health agency, and nine percent who were 
discharged to SNFs.\1\ The proportion of patients being discharged from 
an acute care hospital to a PAC setting was greater among beneficiaries 
enrolled in Medicare fee-for-service (FFS). Among Medicare FFS patients 
discharged from an acute hospital, 42 percent went directly to PAC 
settings. Of that 42 percent, 20 percent were discharged to a SNF, 18 
percent were discharged to a home health agency (HHA), 3 percent were 
discharged to an IRF, and 1 percent were discharged to an LTCH.\2\ Of 
the Medicare FFS beneficiaries with a SNF stay in FY 2017, an estimated 
21 percent were discharged or transferred to an acute care hospital, 11 
percent discharged home with home health

[[Page 17638]]

services, and two percent discharged or transferred to another PAC 
setting (for example, an IRF, a hospice, or another SNF).\3\
---------------------------------------------------------------------------

    \1\ Tian, W. ``An all-payer view of hospital discharge to post-
acute care,'' May 2016. Available at https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
    \2\ Ibid.
    \3\ RTI International analysis of Medicare claims data for index 
stays in SNF 2017. (RTI program reference: IB55).
---------------------------------------------------------------------------

    The transfer and/or exchange of health information from one 
provider to another can be done verbally (for example, clinician-to-
clinician communication in-person or by telephone), paper-based (for 
example, faxed or printed copies of records), and via electronic 
communication (for example, through a health information exchange 
network using an electronic health/medical record, and/or secure 
messaging). Health information, such as medication information, that is 
incomplete or missing increases the likelihood of a patient or resident 
safety risk, and is often life-threatening.4 5 
6 7 8 9 Poor communication 
and coordination across health care settings contributes to patient 
complications, hospital readmissions, emergency department visits, and 
medication errors.10 11 12 
13 14 15 16 17 
18 19 Communication has been cited as the third 
most frequent root cause in sentinel events, which The Joint Commission 
\20\ defines as a patient safety event that results in death, permanent 
harm, or severe temporary harm. Failed or ineffective patient handoffs 
are estimated to play a role in 20 percent of serious preventable 
adverse events.\21\ When care transitions are enhanced through care 
coordination activities, such as expedited patient information flow, 
these activities can reduce duplication of care services and costs of 
care, resolve conflicting care plans, and prevent medical 
errors.22 23 24 25 
26
---------------------------------------------------------------------------

    \4\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G., 
``Medication reconciliation during transitions of care as a patient 
safety strategy: a systematic review,'' Annals of Internal Medicine, 
2013, Vol. 158(5), pp. 397-403.
    \5\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E., 
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission 
medication reconciliation on adverse drug events from admission 
medication changes,'' Archives of Internal Medicine, 2011, Vol. 
171(9), pp. 860-861.
    \6\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman, 
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital 
admission with unintentional discontinuation of medications for 
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \7\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J., 
``Prescribing errors on admission to hospital and their potential 
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol. 
23(1), pp. 17-25.
    \8\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., & 
Hansen, R.A., ``Medication errors during patient transitions into 
nursing homes: characteristics and association with patient harm,'' 
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6), 
pp. 413-422.
    \9\ Boling, P.A., ``Care transitions and home health care,'' 
Clinical Geriatric Medicine, 2009, Vol. 25(1), pp. 135-48.
    \10\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of 
medication information across settings--keeping it free from 
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
    \11\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander, 
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless 
of age: incorporating principles from geriatric medicine to improve 
care transitions for patients with complex needs,'' Journal of 
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
    \12\ Jencks, S.F., Williams, M.V., & Coleman, E.A., 
``Rehospitalizations among patients in the Medicare fee-for-service 
program,'' New England Journal of Medicine, 2009, Vol. 360(14), pp. 
1418-1428.
    \13\ Institute of Medicine. ``Preventing medication errors: 
quality chasm series,'' Washington, DC: The National Academies Press 
2007. Available at https://www.nap.edu/read/11623/chapter/1.
    \14\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G., 
``Developing a medication communication framework across continuums 
of care using the Circle of Care Modeling approach,'' BMC Health 
Services Research, 2013, Vol. 13(1), pp. 1-10.
    \15\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The 
revolving door of rehospitalization from skilled nursing 
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \16\ Institute of Medicine. ``Preventing medication errors: 
quality chasm series,'' Washington, DC: The National Academies Press 
2007. Available at https://www.nap.edu/read/11623/chapter/1.
    \17\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G., 
``Developing a medication communication framework across continuums 
of care using the Circle of Care Modeling approach,'' BMC Health 
Services Research, 2013, Vol. 13(1), pp. 1-10.
    \18\ Forster, A.J., Murff, H.J., Peterson, J.F., Gandhi, T.K., & 
Bates, D.W., ``The incidence and severity of adverse events 
affecting patients after discharge from the hospital.'' Annals of 
Internal Medicine, 2003,138(3), pp. 161-167.
    \19\ King, B.J., Gilmore-Bykovskyi, A.L., Roiland, R.A., 
Polnaszek, B.E., Bowers, B.J., & Kind, A.J. ``The consequences of 
poor communication during transitions from hospital to skilled 
nursing facility: a qualitative study,'' Journal of the American 
Geriatrics Society, 2013, Vol. 61(7), 1095-1102.
    \20\ The Joint Commission, ``Sentinel Event Policy'' available 
at https://www.jointcommission.org/sentinel_event_policy_and_procedures/.
    \21\ The Joint Commission. ``Sentinel Event Data Root Causes by 
Event Type 2004-2015.'' 2016. Available at https://www.jointcommission.org/assets/1/23/jconline_Mar_2_2016.pdf.
    \22\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The 
revolving door of rehospitalization from skilled nursing 
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \23\ Institute of Medicine, ``Preventing medication errors: 
quality chasm series,'' Washington, DC: The National Academies 
Press, 2007. Available at https://www.nap.edu/read/11623/chapter/1.
    \24\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C., 
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner, 
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and 
preventable adverse events among hospitalized children following 
implementation of a resident handoff bundle,'' JAMA, 2013, Vol. 
310(21), pp. 2262-2270.
    \25\ Pronovost, P., M.M.E. Johns, S. Palmer, R.C. Bono, D.B. 
Fridsma, A. Gettinger, J. Goldman, W. Johnson, M. Karney, C. Samitt, 
R.D. Sriram, A. Zenooz, and Y.C. Wang, Editors. Procuring 
Interoperability: Achieving High-Quality, Connected, and Person-
Centered Care. Washington, DC, 2018. National Academy of Medicine. 
Available at https://nam.edu/wp-content/uploads/2018/10/Procuring-Interoperability_web.pdf.
    \26\ Balaban RB, Weissman JS, Samuel PA, & Woolhandler, S., 
``Redefining and redesigning hospital discharge to enhance patient 
care: a randomized controlled study,'' J Gen Intern Med, 2008, Vol. 
23(8), pp. 1228-33.
---------------------------------------------------------------------------

    Care transitions across health care settings have been 
characterized as complex, costly, and potentially hazardous, and may 
increase the risk for multiple adverse outcomes.27 
28 The rising incidence of preventable adverse events, 
complications, and hospital readmissions have drawn attention to the 
importance of the timely transfer of health information and care 
preferences at the time of transition. Failures of care coordination, 
including poor communication of information, were estimated to cost the 
U.S. health care system between $25 billion and $45 billion in wasteful 
spending in 2011.\29\ The communication of health information and 
patient care preferences is critical to ensuring safe and effective 
transitions from one health care setting to another.30 
31
---------------------------------------------------------------------------

    \27\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander, 
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless 
of age: incorporating principles from geriatric medicine to improve 
care transitions for patients with complex needs,'' Journal of 
General Internal Medicine, 2014, Vol 29(6), pp. 932-939.
    \28\ Simmons, S., Schnelle, J., Slagle, J., Sathe, N.A., 
Stevenson, D., Carlo, M., & McPheeters, M.L., ``Resident safety 
practices in nursing home settings.'' Technical Brief No. 24 
(Prepared by the Vanderbilt Evidence-based Practice Center under 
Contract No. 290-2015-00003-I.) AHRQ Publication No. 16-EHC022-EF. 
Rockville, MD: Agency for Healthcare Research and Quality. May 2016. 
Available at https://www.ncbi.nlm.nih.gov/books/NBK384624/.
    \29\ Berwick, D.M. & Hackbarth, A.D. ``Eliminating Waste in US 
Health Care,'' JAMA, 2012, Vol. 307(14), pp.1513-1516.
    \30\ McDonald, K.M., Sundaram, V., Bravata, D.M., Lewis, R., 
Lin, N., Kraft, S.A. & Owens, D.K. Care Coordination. Vol. 7 of: 
Shojania K.G., McDonald K.M., Wachter R.M., Owens D.K., editors. 
``Closing the quality gap: A critical analysis of quality 
improvement strategies.'' Technical Review 9 (Prepared by the 
Stanford University-UCSF Evidence-based Practice Center under 
contract 290-02-0017). AHRQ Publication No. 04(07)-0051-7. 
Rockville, MD: Agency for Healthcare Research and Quality. June 
2006. Available at https://www.ncbi.nlm.nih.gov/books/NBK44015/.
    \31\ Lattimer, C., ``When it comes to transitions in patient 
care, effective communication can make all the difference,'' 
Generations, 2011, Vol. 35(1), pp. 69-72.
---------------------------------------------------------------------------

    Patients in PAC settings often have complicated medication regimens 
and require efficient and effective communication and coordination of 
care between settings, including detailed transfer of medication 
information.32 33 34 Individuals in 
PAC

[[Page 17639]]

settings may be vulnerable to adverse health outcomes due to 
insufficient medication information on the part of their health care 
providers, and the higher likelihood for multiple comorbid chronic 
conditions, polypharmacy, and complicated transitions between care 
settings.35 36 Preventable adverse drug events 
(ADEs) may occur after hospital discharge in a variety of settings 
including PAC.\37\ A 2014 Office of Inspector General report found that 
almost one-tenth of Medicare beneficiaries experienced an ADE, such as 
delirium, bleeding, fall or injury, or constipation, during their stay 
in a SNF in 2011. Of these, two-thirds were classified as 
preventable.\38\ Medication errors and one-fifth of ADEs occur during 
transitions between settings, including admission to or discharge from 
a hospital to home or a PAC setting, or transfer between 
hospitals.39 40
---------------------------------------------------------------------------

    \32\ Starmer A.J., Spector N.D., Srivastava R., West, D.C., 
Rosenbluth, G., Allen, A.D., Noble, E.L., & Landrigen, C.P., 
``Changes in medical errors after implementation of a handoff 
program,'' N Engl J Med, 2014, Vol. 37(1), pp. 1803-1812.
    \33\ Kruse, C.S. Marquez, G., Nelson, D., & Polomares, O., ``The 
use of health information exchange to augment patient handoff in 
long-term care: a systematic review,'' Applied Clinical Informatics, 
2018, Vol. 9(4), pp. 752-771.
    \34\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H., 
Thraen, I., Coarr, M.E., & Rupper, R., ``High prevalence of 
medication discrepancies between home health referrals and Centers 
for Medicare and Medicaid Services home health certification and 
plan of care and their potential to affect safety of vulnerable 
elderly adults,'' Journal of the American Geriatrics Society, 2016, 
Vol. 64(11), pp. e166 e170.
    \35\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E., 
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation 
during the transition to and from long-term care settings: a 
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
    \36\ Levinson, D.R., & General, I., ``Adverse events in skilled 
nursing facilities: national incidence among Medicare 
beneficiaries.'' Washington, DC: U.S. Department of Health and Human 
Services, Office of Inspector General, February 2014. Available at 
https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
    \37\ Battles J., Azam I., Grady M., & Reback K., ``Advances in 
patient safety and medical liability,'' AHRQ Publication No. 17-
0017-EF. Rockville, MD: Agency for Healthcare Research and Quality, 
August 2017. Available at https://www.ahrq.gov/sites/default/files/publications/files/advances-complete_3.pdf.
    \38\ Health and Human Services Office of Inspector General. 
Adverse events in skilled nursing facilities: National incidence 
among Medicare beneficiaries. OEI-06-11-00370). 2014. Available at 
https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
    \39\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of 
medication information across settings--keeping it free from 
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
    \40\ Gleason, K.M., Groszek, J.M., Sullivan, C., Rooney, D., 
Barnard, C., Noskin, G.A., ``Reconciliation of discrepancies in 
medication histories and admission orders of newly hospitalized 
patients,'' American Journal of Health System Pharmacy, 2004, Vol. 
61(16), pp. 1689-1694.
---------------------------------------------------------------------------

    Patients in PAC settings are often taking multiple medications. 
Consequently, PAC providers regularly are in the position of starting 
complex new medication regimens with little knowledge of the patients 
or their medication history upon admission. Furthermore, inter-facility 
communication barriers delay resolving medication discrepancies during 
transitions of care.\41\ Medication discrepancies are common,\42\ and 
found to occur in 86 percent of all transitions, increasing the 
likelihood of ADEs.43 44 45 Up to 90 
percent of patients experience at least one medication discrepancy in 
the transition from hospital to home care, and discrepancies occur 
within all therapeutic classes of medications.46 
47
---------------------------------------------------------------------------

    \41\ Patterson M., Foust J.B., Bollinger, S., Coleman, C., 
Nguyen, D., ``Inter-facility communication barriers delay resolving 
medication discrepancies during transitions of care,'' Research in 
Social & Administrative Pharmacy (2018), doi: 10.1016/
j.sapharm.2018.05.124.
    \42\ Manias, E., Annaikis, N., Considine, J., Weerasuriya, R., & 
Kusljic, S. ``Patient-, medication- and environment-related factors 
affecting medication discrepancies in older patients,'' Collegian, 
2017, Vol. 24, pp. 571-577.
    \43\ Tjia, J., Bonner, A., Briesacher, B.A., McGee, S., Terrill, 
E., Miller, K., ``Medication discrepancies upon hospital to skilled 
nursing facility transitions,'' J Gen Intern Med, 2009, Vol. 24(5), 
pp. 630-635.
    \44\ Sinvani, L.D., Beizer, J., Akerman, M., Pekmezaris, R., 
Nouryan, C., Lutsky, L., Cal, C., Dlugacz, Y., Masick, K., Wolf-
Klein, G.,''Medication reconciliation in continuum of care 
transitions: a moving target,'' J Am Med Dir Assoc, 2013, Vol. 
14(9), 668-672.
    \45\ Coleman E.A., Parry C., Chalmers S., & Min, S.J., ``The 
Care Transitions Intervention: results of a randomized controlled 
trial,'' Arch Intern Med, 2006, Vol. 166, pp. 1822-1828.
    \46\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, l.D., 
``Nurse identified hospital to home medication discrepancies: 
implications for improving transitional care,'' Geriatr Nurs, 2011, 
Vol. 31(3), pp. 188-196.
    \47\ Setter S.M., Corbett C.F., Neumiller J.J., Gates, B.J., 
Sclar, D.A., & Sonnett, T.E., ``Effectiveness of a pharmacist-nurse 
intervention on resolving medication discrepancies in older patients 
transitioning from hospital to home care: impact of a pharmacy/
nursing intervention,'' Am J Health Syst Pharm, 2009, Vol. 66, pp. 
2027-2031.
---------------------------------------------------------------------------

    Transfer of a medication list between providers is necessary for 
medication reconciliation interventions, which have been shown to be a 
cost-effective way to avoid ADEs by reducing errors,48 
49 50 especially when medications are reviewed by 
a pharmacist using electronic medical records.\51\
---------------------------------------------------------------------------

    \48\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E., 
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission 
medication reconciliation on adverse drug events from admission 
medication changes,'' Archives of Internal Medicine, 2011, Vol. 
171(9), pp. 860-861.
    \49\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G., 
``Medication reconciliation during transitions of care as a patient 
safety strategy: a systematic review,'' Annals of Internal Medicine, 
2013, Vol. 158(5), pp. 397-403.
    \50\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E., 
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation 
during the transition to and from long-term care settings: a 
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
    \51\ Agrawal A, Wu WY. ``Reducing medication errors and 
improving systems reliability using an electronic medication 
reconciliation system,'' The Joint Commission Journal on Quality and 
Patient Safety, 2009, Vol. 35(2), pp. 106-114.
---------------------------------------------------------------------------

(2) Stakeholder and Technical Expert Panel (TEP) Input
    The proposed measure was developed after consideration of feedback 
we received from stakeholders and four TEPs convened by our 
contractors. Further, the proposed measure was developed after 
evaluation of data collected during two pilot tests we conducted in 
accordance with the CMS Measures Management System Blueprint.
    Our measure development contractors constituted a TEP which met on 
September 27, 2016,\52\ January 27, 2017, and August 3, 2017 \53\ to 
provide input on a prior version of this measure. Based on this input, 
we updated the measure concept in late 2017 to include the transfer of 
a specific component of health information--medication information. Our 
measure development contractors reconvened this TEP on April 20, 2018 
for the purpose of obtaining expert input on the proposed measure, 
including the measure's reliability, components of face validity, and 
feasibility of being implemented across PAC settings. Overall, the TEP 
was supportive of the proposed measure, affirming that the measure 
provides an opportunity to improve the transfer of medication 
information. A summary of the April 20, 2018 TEP proceedings titled 
``Transfer of Health Information TEP Meeting 4-June 2018'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-

[[Page 17640]]

Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-
of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \52\ Technical Expert Panel Summary Report: Development of two 
quality measures to satisfy the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health 
Information and Care Preferences When an Individual Transitions to 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation 
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health 
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
    \53\ Technical Expert Panel Summary Report: Development of two 
quality measures to satisfy the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health 
Information and Care Preferences When an Individual Transitions to 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation 
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health 
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
---------------------------------------------------------------------------

    Our measure development contractors solicited stakeholder feedback 
on the proposed measure by requesting comment on the CMS Measures 
Management System Blueprint website, and accepted comments that were 
submitted from March 19, 2018 to May 3, 2018. The comments received 
expressed overall support for the measure. Several commenters suggested 
ways to improve the measure, primarily related to what types of 
information should be included at transfer. We incorporated this input 
into development of the proposed measure. The summary report for the 
March 19 to May 3, 2018 public comment period titled ``IMPACT 
Medication-Profile-Transferred-Public-Comment-Summary-Report'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(3) Pilot Testing
    The proposed measure was tested between June and August 2018 in a 
pilot test that involved 24 PAC facilities/agencies, including five 
IRFs, six SNFs, six LTCHs, and seven HHAs. The 24 pilot sites submitted 
a total of 801 records. Analysis of agreement between coders within 
each participating facility (266 qualifying pairs) indicated a 93-
percent agreement for this measure. Overall, pilot testing enabled us 
to verify its reliability, components of face validity, and feasibility 
of being implemented across PAC settings. Further, more than half of 
the sites that participated in the pilot test stated during the 
debriefing interviews that the measure could distinguish facilities or 
agencies with higher quality medication information transfer from those 
with lower quality medication information transfer at discharge. The 
pilot test summary report titled ``Transfer of Health Information 2018 
Pilot Test Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(4) Measure Applications Partnership (MAP) Review and Related Measures
    We included the proposed measure in the SNF QRP section of the 2018 
Measures Under Consideration (MUC) list. The MAP conditionally 
supported this measure pending NQF endorsement, noting that the measure 
can promote the transfer of important medication information. The MAP 
also suggested that CMS consider a measure that can be adapted to 
capture bi-directional information exchange, and recommended that the 
medication information transferred include important information about 
supplements and opioids. More information about the MAP's 
recommendations for this measure is available at http://www.qualityforum.org/Publications/2019/02/MAP_2019_Considerations_for_Implementing_Measures_Final_Report_-_PAC-LTC.aspx.
    As part of the measure development and selection process, we also 
identified one NQF-endorsed quality measure similar to the proposed 
measure, titled Documentation of Current Medications in the Medical 
Record (NQF #0419, CMS eCQM ID: CMS68v8). This measure was adopted as 
one of the recommended adult core clinical quality measures for 
eligible professionals for the EHR Incentive Program beginning in 2014, 
and was also adopted under the Merit-based Incentive Payment System 
(MIPS) quality performance category beginning in 2017. The measure is 
calculated based on the percentage of visits for patients aged 18 years 
and older for which the eligible professional or eligible clinician 
attests to documenting a list of current medications using all 
resources immediately available on the date of the encounter.
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) measure addresses the transfer of information whereas 
the NQF-endorsed measure #0419 assesses the documentation of 
medications, but not the transfer of such information. This is 
important as the proposed measure assesses for the transfer of 
medication information for the proposed measure calculation. Further, 
the proposed measure utilizes standardized patient assessment data 
elements (SPADEs), which is a requirement for measures specified under 
the Transfer of Health Information measure domain under section 
1899B(c)(1)(E) of the Act, whereas NQF #0419 does not.
    After review of the NQF-endorsed measure, we determined that the 
proposed Transfer of Health Information to the Provider-Post-Acute Care 
(PAC) measure better addresses the Transfer of Health Information 
measure domain, which requires that at least some of the data used to 
calculate the measure be collected as standardized patient assessment 
data through the post-acute care assessment instruments. Section 
1899B(e)(2)(A) of the Act requires that any measure specified by the 
Secretary be endorsed by the entity with a contract under section 
1890(a) of the Act, which is currently the National Quality Form (NQF). 
However, when a feasible and practical measure has not been NQF 
endorsed for a specified area or medical topic determined appropriate 
by the Secretary, section 1899B(e)(2)(B) of the Act allows the 
Secretary to specify a measure that is not NQF endorsed as long as due 
consideration is given to the measures that have been endorsed or 
adopted by a consensus organization identified by the Secretary. For 
the reasons discussed above, we believe that there is currently no 
feasible NQF-endorsed measure that we could adopt under section 
1899B(c)(1)(E) of the Act. However, we note that we intend to submit 
the proposed measure to the NQF for consideration of endorsement when 
feasible.
(5) Quality Measure Calculation
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) quality measure is calculated as the proportion of 
resident stays with a discharge assessment indicating that a current 
reconciled medication list was provided to the subsequent provider at 
the time of discharge. The proposed measure denominator is the total 
number of SNF resident stays, ending in discharge to a ``subsequent 
provider,'' which is defined as a short-term general acute-care 
hospital, a skilled nursing facility (SNF), intermediate care 
(intellectual and developmental disabilities providers), home under 
care of an organized home health service organization or hospice, 
hospice in an institutional facility, an inpatient rehabilitation 
facility (IRF), an LTCH, a Medicaid nursing facility, an inpatient 
psychiatric facility, or a critical access hospital (CAH). These health 
care providers were selected for inclusion in the denominator because 
they are identified as subsequent providers on the discharge 
destination item that is currently included on the resident assessment 
instrument minimum data set (MDS), the current version being MDS 3.0. 
The proposed measure numerator is the number of SNF resident stays with 
an MDS discharge assessment indicating a current reconciled medication 
list was provided to the subsequent provider at the time of discharge. 
For additional technical information about this proposed

[[Page 17641]]

measure, we refer readers to the document titled, ``Proposed 
Specifications for SNF QRP Quality Measures and Standardized Patient 
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. The data source for the proposed quality measure is the 
MDS assessment instrument for SNF residents.
    For more information about the data submission requirements we are 
proposing for this measure, we refer readers to section VI.A.8.c. of 
this proposed rule.
b. Proposed Transfer of Health Information to the Patient-Post-Acute 
Care (PAC) Measure
    Beginning with the FY 2022 SNF QRP, we are proposing to adopt the 
Transfer of Health Information to the Patient-Post-Acute Care (PAC) 
measure, a measure that satisfies the IMPACT Act domain of Transfer of 
Health Information, with data collection for discharges beginning 
October 1, 2020. This process-based measure assesses whether or not a 
current reconciled medication list was provided to the patient, family, 
or caregiver when the patient was discharged from a PAC setting to a 
private home/apartment, a board and care home, assisted living, a group 
home, transitional living or home under care of an organized home 
health service organization, or a hospice.
(1) Background
    In 2013, 22.3 percent of all acute hospital discharges were 
discharged to PAC settings, including 11 percent who were discharged to 
home under the care of a home health agency.\54\ Of the Medicare FFS 
beneficiaries with a SNF stay in fiscal year 2017, an estimated 11 
percent were discharged home with home health services, 41 percent were 
discharged home with self-care, and 0.2 percent were discharged with 
home hospice services.\55\
---------------------------------------------------------------------------

    \54\ Tian, W. ``An all-payer view of hospital discharge to 
postacute care,'' May 2016. Available at https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
    \55\ RTI International analysis of Medicare claims data for 
index stays in SNF 2017. (RTI program reference: IB55).
---------------------------------------------------------------------------

    The communication of health information, such as a reconciled 
medication list, is critical to ensuring safe and effective patient 
transitions from health care settings to home and/or other community 
settings. Incomplete or missing health information, such as medication 
information, increases the likelihood of a patient safety risk, often 
life-threatening.56 57 58 
59 60 Individuals who use PAC care services are 
particularly vulnerable to adverse health outcomes due to their higher 
likelihood of having multiple comorbid chronic conditions, 
polypharmacy, and complicated transitions between care 
settings.61 62 Upon discharge to home, 
individuals in PAC settings may be faced with numerous medication 
changes, new medication regimes, and follow-up details.63 
64 65 The efficient and effective communication 
and coordination of medication information may be critical to prevent 
potentially deadly adverse effects. When care coordination activities 
enhance care transitions, these activities can reduce duplication of 
care services and costs of care, resolve conflicting care plans, and 
prevent medical errors.66 67
---------------------------------------------------------------------------

    \56\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G., 
``Medication reconciliation during transitions of care as a patient 
safety strategy: a systematic review,'' Annals of Internal Medicine, 
2013, Vol. 158(5), pp. 397-403.
    \57\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E., 
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission 
medication reconciliation on adverse drug events from admission 
medication changes,'' Archives of Internal Medicine, 2011, Vol. 
171(9), pp. 860-861.
    \58\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman, 
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital 
admission with unintentional discontinuation of medications for 
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \59\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J., 
``Prescribing errors on admission to hospital and their potential 
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol. 
23(1), pp. 17-25.
    \60\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., & 
Hansen, R.A., ``Medication errors during patient transitions into 
nursing homes: characteristics and association with patient harm,'' 
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6), 
pp. 413-422.
    \61\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H., 
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of 
medication discrepancies between home health referrals and Centers 
for Medicare and Medicaid Services home health certification and 
plan of care and their potential to affect safety of vulnerable 
elderly adults,'' Journal of the American Geriatrics Society, 2016, 
Vol. 64(11), pp. e166-e170.
    \62\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E., 
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation 
during the transition to and from long-term care settings: a 
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
    \63\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H., 
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of 
medication discrepancies between home health referrals and Centers 
for Medicare and Medicaid Services home health certification and 
plan of care and their potential to affect safety of vulnerable 
elderly adults,'' Journal of the American Geriatrics Society, 2016, 
Vol. 64(11), pp. e166-e170.
    \64\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman, 
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital 
admission with unintentional discontinuation of medications for 
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \65\ Sheehan, O.C., Kharrazi, H., Carl, K.J., Leff, B., Wolff, 
J.L., Roth, D.L., Gabbard, J., & Boyd, C.M., ``Helping older adults 
improve their medication experience (HOME) by addressing medication 
regimen complexity in home healthcare,'' Home Healthcare Now. 2018, 
Vol. 36(1) pp. 10-19.
    \66\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The 
revolving door of rehospitalization from skilled nursing 
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \67\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C., 
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner, 
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and 
preventable adverse events among hospitalized children following 
implementation of a resident handoff bundle,'' JAMA, 2013, Vol. 
310(21), pp. 2262-2270.
---------------------------------------------------------------------------

    Finally, the transfer of a patient's discharge medication 
information to the patient, family, or caregiver is common practice and 
supported by discharge planning requirements for participation in 
Medicare and Medicaid programs.68 69 Most PAC EHR 
systems generate a discharge medication list to promote patient 
participation in medication management, which has been shown to be 
potentially useful for improving patient outcomes and transitional 
care.\70\
---------------------------------------------------------------------------

    \68\ CMS, ``Revision to state operations manual (SOM), Hospital 
Appendix A--Interpretive Guidelines for 42 CFR 482.43, Discharge 
Planning'' May 17, 2013. Available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-32.pdf.
    \69\ The State Operations Manual Guidance to Surveyors for Long 
Term Care Facilities (Guidance Sec.  483.21(c)(1) Rev. 11-22-17) for 
discharge planning process. Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
    \70\ Toles, M., Colon-Emeric, C., Naylor, M.D., Asafu-Adjei, J., 
Hanson, L.C., ``Connect-home: transitional care of skilled nursing 
facility patients and their caregivers,'' Am Geriatr Soc., 2017, 
Vol. 65(10), pp. 2322-2328.
---------------------------------------------------------------------------

(2) Stakeholder and Technical Expert Panel (TEP) Input
    The proposed measure was developed after consideration of feedback 
we received from stakeholders and four TEPs convened by our 
contractors. Further, the proposed measure was developed after 
evaluation of data collected during two pilot tests we conducted in 
accordance with the CMS MMS Blueprint.
    Our measure development contractors constituted a TEP which met on 
September 27, 2016,\71\ January 27, 2017,

[[Page 17642]]

and August 3, 2017 \72\ to provide input on a prior version of this 
measure. Based on this input, we updated the measure concept in late 
2017 to include the transfer of a specific component of health 
information--medication information. Our measure development 
contractors reconvened this TEP on April 20, 2018 to seek expert input 
on the measure. Overall, the TEP members supported the proposed 
measure, affirming that the measure provides an opportunity to improve 
the transfer of medication information. Most of the TEP members 
believed that the measure could improve the transfer of medication 
information to patients, families, and caregivers. Several TEP members 
emphasized the importance of transferring information to patients and 
their caregivers in a clear manner using plain language. A summary of 
the April 20, 2018 TEP proceedings titled ``Transfer of Health 
Information TEP Meeting 4--June 2018'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \71\ Technical Expert Panel Summary Report: Development of two 
quality measures to satisfy the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health 
Information and Care Preferences When an Individual Transitions to 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation 
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health 
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
    \72\ Technical Expert Panel Summary Report: Development of two 
quality measures to satisfy the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health 
Information and Care Preferences When an Individual Transitions to 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation 
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health 
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
---------------------------------------------------------------------------

    Our measure development contractors solicited stakeholder feedback 
on the proposed measure by requesting comment on the CMS Measures 
Management System Blueprint website, and accepted comments that were 
submitted from March 19, 2018 to May 3, 2018. Several commenters noted 
the importance of ensuring that the instruction provided to patients 
and caregivers is clear and understandable to promote transparent 
access to medical record information and meet the goals of the IMPACT 
Act. The summary report for the March 19 to May 3, 2018 public comment 
period titled ``IMPACT- Medication Profile Transferred Public Comment 
Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(3) Pilot Testing
    Between June and August 2018, we held a pilot test involving 24 PAC 
facilities/agencies, including five IRFs, six SNFs, six LTCHs, and 
seven HHAs. The 24 pilot sites submitted a total of 801 assessments. 
Analysis of agreement between coders within each participating facility 
(241 qualifying pairs) indicated an 87 percent agreement for this 
measure. Overall, pilot testing enabled us to verify its reliability, 
components of face validity, and feasibility of being implemented 
across PAC settings. Further, more than half of the sites that 
participated in the pilot test stated, during debriefing interviews, 
that the measure could distinguish facilities or agencies with higher 
quality medication information transfer from those with lower quality 
medication information transfer at discharge. The pilot test summary 
report titled ``Transfer of Health Information 2018 Pilot Test Summary 
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(4) Measure Applications Partnership (MAP) Review and Related Measures
    We included the proposed measure in the SNF QRP section of the 2018 
MUC list. The MAP conditionally supported this measure pending NQF 
endorsement, noting that the measure can promote the transfer of 
important medication information to the patient. The MAP recommended 
that providers transmit medication information to patients that is easy 
to understand because health literacy can impact a person's ability to 
take medication as directed. More information about the MAP's 
recommendations for this measure is available at http://www.qualityforum.org/Publications/2019/02/MAP_2019_Considerations_for_Implementing_Measures_Final_Report_-_PAC-LTC.aspx.
    Section 1899B(e)(2)(A) of the Act, requires that any measure 
specified by the Secretary be endorsed by the entity with a contract 
under section 1890(a) of the Act, which is currently the NQF. However, 
when a feasible and practical measure has not been NQF-endorsed for a 
specified area or medical topic determined appropriate by the 
Secretary, section 1899B(e)(2)(B) of the Act allows the Secretary to 
specify a measure that is not NQF-endorsed as long as due consideration 
is given to the measures that have been endorsed or adopted by a 
consensus organization identified by the Secretary. Therefore, in the 
absence of any NQF-endorsed measures that address the proposed Transfer 
of Health Information to the Patient-Post-Acute Care (PAC), which 
requires that at least some of the data used to calculate the measure 
be collected as standardized patient assessment data through the post-
acute care assessment instruments, we believe that there is currently 
no feasible NQF-endorsed measure that we could adopt under section 
1899B(c)(1)(E) of the Act. However, we note that we intend to submit 
the proposed measure to the NQF for consideration of endorsement when 
feasible.
(5) Quality Measure Calculation
    The calculation of the proposed Transfer of Health Information to 
the Patient-Post-Acute Care (PAC) measure would be based on the 
proportion of resident stays with a discharge assessment indicating 
that a current reconciled medication list was provided to the resident, 
family, or caregiver at the time of discharge.
    The proposed measure denominator is the total number of SNF 
resident stays ending in discharge to a private home/apartment, a board 
and care home, assisted living, a group home, transitional living or 
home under care of an organized home health service organization, or a 
hospice. These locations were selected for inclusion in the denominator 
because they are identified as home locations on the discharge 
destination item that is currently included on the MDS. The proposed 
measure numerator is the number of SNF resident stays with an MDS 
discharge assessment indicating a current reconciled medication list 
was provided to the resident, family, or caregiver at the time of 
discharge. For technical information about this proposed measure we 
refer readers to the document titled ``Proposed Specifications for SNF 
QRP Quality Measures and Standardized Patient Assessment Data 
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. 
Data for the proposed quality measure would be calculated using data 
from the MDS assessment instrument for SNF residents.
    For more information about the data submission requirements we are

[[Page 17643]]

proposing for this measure, we refer readers to section VI.A.8.c. of 
this proposed rule.
c. Proposed Update to the Discharge to Community--Post Acute Care (PAC) 
Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) Measure
    We are proposing to update the specifications for the Discharge to 
Community--PAC SNF QRP measure to exclude baseline nursing facility 
(NF) residents from the measure. This measure reports a SNF's risk-
standardized rate of Medicare FFS residents who are discharged to the 
community following a SNF stay, do not have an unplanned readmission to 
an acute care hospital or LTCH in the 31 days following discharge to 
community, and who remain alive during the 31 days following discharge 
to community. We adopted this measure in the FY 2017 SNF PPS final rule 
(81 FR 52021 through 52029).
    In the FY 2017 SNF PPS final rule (81 FR 52025), we addressed 
public comments recommending exclusion of SNF residents who were 
baseline NF residents, as these residents lived in a NF prior to their 
SNF stay and may not be expected to return to the community following 
their SNF stay. In the FY 2018 SNF PPS final rule (82 FR 36596), we 
addressed public comments expressing support for a potential future 
modification of the measure that would exclude baseline NF residents; 
commenters stated that the exclusion would result in the measure more 
accurately portraying quality of care provided by SNFs, while 
controlling for factors outside of SNF control.
    We assessed the impact of excluding baseline NF residents from the 
measure using CY 2015 and CY 2016 data, and found that this exclusion 
impacted both patient- and facility-level discharge to community rates. 
We defined baseline NF residents as SNF residents who had a long-term 
NF stay in the 180 days preceding their hospitalization and SNF stay, 
with no intervening community discharge between the NF stay and 
qualifying hospitalization for measure inclusion. Baseline NF residents 
represented 10.4 percent of the measure population after all measure 
exclusions were applied. Observed resident-level discharge to community 
rates were significantly lower for baseline NF residents (2.37 percent) 
compared with non-NF residents (53.32 percent). The national observed 
resident-level discharge to community rate was 48.01 percent when 
baseline NF residents were included in the measure, increasing to 53.32 
percent when they were excluded from the measure. After excluding 
baseline NF residents, 38.5 percent of SNFs had an increase in their 
risk-standardized discharge to community rate that exceeded the 
increase in the national observed resident-level discharge to community 
rate.
    Based on public comments received and our impact analysis, we are 
proposing to exclude baseline NF residents from the Discharge to 
Community--PAC SNF QRP measure beginning with the FY 2020 SNF QRP, with 
baseline NF residents defined as SNF residents who had a long-term NF 
stay in the 180 days preceding their hospitalization and SNF stay, with 
no intervening community discharge between the NF stay and 
hospitalization.
    For additional technical information regarding the Discharge to 
Community--PAC SNF QRP measure, including technical information about 
the proposed exclusion, we refer readers to the document titled 
``Proposed Specifications for SNF QRP Quality Measures and Standardized 
Resident Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We are inviting public comment on this proposal.
5. SNF QRP Quality Measures, Measure Concepts, and Standardized Patient 
Assessment Data Elements Under Consideration for Future Years: Request 
for Information
    We are seeking input on the importance, relevance, appropriateness, 
and applicability of each of the measures, standardized patient 
assessment data elements (SPADEs), and concepts under consideration 
listed in the Table 13 for future years in the SNF QRP.

  Table 13--Future Measures, Measure Concepts, and Standardized Patient
  Assessment Data Elements (SPADEs) Under Consideration for the SNF QRP
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Assessment-Based Quality Measures and Measure Concepts:
    Functional maintenance outcomes.
    Opioid use and frequency.
    Exchange of electronic health information and interoperability.
Claims-Based:
    Healthcare-Associated Infections in Skilled Nursing Facility (SNF)--
     claims-based.
Standardized Patient Assessment Data Elements (SPADEs):
    Cognitive complexity, such as executive function and memory.
    Dementia.
    Bladder and bowel continence including appliance use and episodes of
     incontinence.
    Care preferences, advance care directives, and goals of care.
    Caregiver Status.
    Veteran Status.
    Health disparities and risk factors, including education, sex and
     gender identity, and sexual orientation.
------------------------------------------------------------------------

    While we will not be responding to specific comments submitted in 
response to this Request for Information in the FY 2020 SNF PPS final 
rule, we intend to use this input to inform our future measure and 
SPADE development efforts
6. Proposed Standardized Patient Assessment Data Reporting Beginning 
With the FY 2022 SNF QRP
    Section 1888(e)(6)(B)(i)(III) of the Act requires that, for fiscal 
years 2019 and each subsequent year, SNFs must report standardized 
patient \73\ assessment data (SPADE) required under section

[[Page 17644]]

1899B(b)(1) of the Act. Section 1899B(a)(1)(C) of the Act requires, in 
part, the Secretary to modify the PAC assessment instruments in order 
for PAC providers, including SNFs, to submit SPADEs under the Medicare 
program. Section 1899B(b)(1)(A) of the Act requires PAC providers to 
submit SPADEs under applicable reporting provisions (which, for SNFs, 
is the SNF QRP) with respect to the admission and discharge of an 
individual (and more frequently as the Secretary deems appropriate), 
and section 1899B(b)(1)(B) of the Act defines standardized patient 
assessment data as data required for at least the quality measures 
described in section 1899B(c)(1) of the Act and that is with respect to 
the following categories: (1) Functional status, such as mobility and 
self-care at admission to a PAC provider and before discharge from a 
PAC provider; (2) cognitive function, such as ability to express ideas 
and to understand, and mental status, such as depression and dementia; 
(3) special services, treatments, and interventions, such as need for 
ventilator use, dialysis, chemotherapy, central line placement, and 
total parenteral nutrition; (4) medical conditions and comorbidities, 
such as diabetes, congestive heart failure, and pressure ulcers; (5) 
impairments, such as incontinence and an impaired ability to hear, see, 
or swallow, and (6) other categories deemed necessary and appropriate 
by the Secretary.
---------------------------------------------------------------------------

    \73\ In the FY 2018 SNF PPS final rule, we used the term 
``standardized resident assessment data'' to refer to standardized 
assessment data elements collected from SNF residents. However, in 
this proposed rule and going forward, we will use the term 
``standardized patient assessment data'' to refer to the collect of 
SPADEs from SNF residents.
---------------------------------------------------------------------------

    In the FY 2018 SNF PPS proposed rule (82 FR 21059 through 21076), 
we proposed to adopt SPADEs that would satisfy the first five 
categories. In the FY 2018 SNF PPS final rule, commenters expressed 
support for our adoption of SPADEs in general, including support for 
our broader standardization goal and support for the clinical 
usefulness of specific proposed SPADEs. However, we did not finalize 
the majority of our SPADE proposals in recognition of the concern 
raised by many commenters that we were moving too fast to adopt the 
SPADEs and modify our assessment instruments in light of all of the 
other requirements we were also adopting under the IMPACT Act at that 
time (82 FR 36598 through 36600). In addition, we noted our intention 
to conduct extensive testing to ensure that the standardized patient 
assessment data elements we select are reliable, valid, and appropriate 
for their intended use (82 FR 36599).
    We did, however, finalize the adoption of SPADEs for two of the 
categories described in section 1899B(b)(1)(B) of the Act: (1) 
Functional status: Data elements currently reported by SNFs to 
calculate the measure Application of Percent of Long-Term Care Hospital 
Patients with an Admission and Discharge Functional Assessment and a 
Care Plan That Addresses Function (NQF #2631); and (2) Medical 
conditions and comorbidities: The data elements used to calculate the 
pressure ulcer measures, Percent of Residents or Patients with Pressure 
Ulcers That Are New or Worsened (Short Stay) (NQF #0678) and the 
replacement measure, Changes in Skin Integrity Post-Acute Care: 
Pressure Ulcer/Injury. We stated that these data elements were 
important for care planning, known to be valid and reliable, and 
already being reported by SNFs for the calculation of quality measures.
    Since we issued the FY 2018 SNF PPS final rule, SNFs have had an 
opportunity to familiarize themselves with other new reporting 
requirements that we have adopted under the IMPACT Act. We have also 
conducted further testing of the SPADEs, as described more fully below, 
and believe that this testing supports the use of the SPADEs in our PAC 
assessment instruments. Therefore, we are now proposing to adopt many 
of the same SPADEs that we previously proposed to adopt, along with 
other SPADEs.
    We are proposing that SNFs would be required to report these SPADEs 
beginning with the FY 2022 SNF QRP. If finalized as proposed, SNFs 
would be required to report these data with respect to SNF admissions 
and discharges that occur between October 1, 2020 and December 31, 2020 
for the FY 2022 SNF QRP. Beginning with the FY 2023 SNF QRP, we propose 
that SNFs must report data with respect to admissions and discharges 
that occur during the subsequent calendar year (for example, CY 2021 
for the FY 2023 SNF QRP, CY 2022 for the FY 2024 SNF QRP).
    We are also proposing that SNFs that submit the Hearing, Vision, 
Race, and Ethnicity SPADEs with respect to admission only will be 
deemed to have submitted those SPADEs with respect to both admission 
and discharge, because it is unlikely that the assessment of those 
SPADEs at admission will differ from the assessment of the same SPADEs 
at discharge.
    In selecting the proposed SPADEs below, we considered the burden of 
assessment-based data collection and aimed to minimize additional 
burden by evaluating whether any data that is currently collected 
through one or more PAC assessment instruments could be collected as 
SPADE. In selecting the proposed SPADEs below, we also took into 
consideration the following factors with respect to each data element:
    (1) Overall clinical relevance;
    (2) Interoperable exchange to facilitate care coordination during 
transitions in care;
    (3) Ability to capture medical complexity and risk factors that can 
inform both payment and quality; and
    (4) Scientific reliability and validity, general consensus 
agreement for its usability.
    In identifying the SPADEs proposed below, we additionally drew on 
input from several sources, including TEPs held by our data element 
contractor, public input, and the results of a recent National Beta 
Test of candidate data elements conducted by our data element 
contractor (hereafter ``National Beta Test'').
    The National Beta Test collected data from 3,121 patients and 
residents across 143 LTCHs, SNFs, IRFs, and HHAs from November 2017 to 
August 2018 to evaluate the feasibility, reliability, and validity of 
candidate data elements across PAC settings. The National Beta Test 
also gathered feedback on the candidate data elements from staff who 
administered the test protocol in order to understand usability and 
workflow of the candidate data elements. More information on the 
methods, analysis plan, and results for the National Beta Test are 
available in the document titled, ``Development and Evaluation of 
Candidate Standardized Patient Assessment Data Elements: Findings from 
the National Beta Test (Volume 2),'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Further, to inform the proposed SPADEs, we took into account 
feedback from stakeholders, as well as from technical and clinical 
experts, including feedback on whether the candidate data elements 
would support the factors described above. Where relevant, we also took 
into account the results of the Post-Acute Care Payment Reform 
Demonstration (PAC PRD) that took place from 2006 to 2012.
7. Proposed Standardized Patient Assessment Data by Category
a. Cognitive Function and Mental Status Data
    A number of underlying conditions, including dementia, stroke, 
traumatic brain injury, side effects of medication, metabolic and/or 
endocrine imbalances, delirium, and depression, can affect cognitive 
function and mental status in

[[Page 17645]]

PAC patient and resident populations.\74\ The assessment of cognitive 
function and mental status by PAC providers is important because of the 
high percentage of patients and residents with these conditions,\75\ 
and because these assessments provide opportunity for improving quality 
of care.
---------------------------------------------------------------------------

    \74\ National Institute on Aging. (2014). Assessing Cognitive 
Impairment in Older Patients. A Quick Guide for Primary Care 
Physicians. Retrieved from https://www.nia.nih.gov/alzheimers/publication/assessing-cognitive-impairment-older-patients.
    \75\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute 
Care Payment Reform Demonstration (Final report, Volume 4 of 4). 
Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------

    Symptoms of dementia may improve with pharmacotherapy, occupational 
therapy, or physical activity,76 77 78 and promising 
treatments for severe traumatic brain injury are currently being 
tested.\79\ For older patients and residents diagnosed with depression, 
treatment options to reduce symptoms and improve quality of life 
include antidepressant medication and 
psychotherapy,80 81 82 83 and targeted services, such as 
therapeutic recreation, exercise, and restorative nursing, to increase 
opportunities for psychosocial interaction.\84\
---------------------------------------------------------------------------

    \76\ Casey D.A., Antimisiaris D., O'Brien J. (2010). Drugs for 
Alzheimer's Disease: Are They Effective? Pharmacology & 
Therapeutics, 35, 208-211.
    \77\ Graff M.J., Vernooij-Dassen M.J., Thijssen M., Dekker J., 
Hoefnagels W.H., Rikkert M.G.O. (2006). Community Based Occupational 
Therapy for Patients with Dementia and their Care Givers: Randomised 
Controlled Trial. BMJ, 333(7580): 1196.
    \78\ Bherer L., Erickson K.I., Liu-Ambrose T. (2013). A Review 
of the Effects of Physical Activity and Exercise on Cognitive and 
Brain Functions in Older Adults. Journal of Aging Research, 657508.
    \79\ Giacino J.T., Whyte J., Bagiella E., et al. (2012). 
Placebo-controlled trial of amantadine for severe traumatic brain 
injury. New England Journal of Medicine, 366(9), 819-826.
    \80\ Alexopoulos G.S., Katz I.R., Reynolds C.F. 3rd, Carpenter 
D., Docherty J.P., Ross R.W. (2001). Pharmacotherapy of depression 
in older patients: a summary of the expert consensus guidelines. 
Journal of Psychiatric Practice, 7(6), 361-376.
    \81\ Arean P.A., Cook B.L. (2002). Psychotherapy and combined 
psychotherapy/pharmacotherapy for late life depression. Biological 
Psychiatry, 52(3), 293-303.
    \82\ Hollon S.D., Jarrett R.B., Nierenberg A.A., Thase M.E., 
Trivedi M., Rush A.J. (2005). Psychotherapy and medication in the 
treatment of adult and geriatric depression: which monotherapy or 
combined treatment? Journal of Clinical Psychiatry, 66(4), 455-468.
    \83\ Wagenaar D., Colenda C.C., Kreft M., Sawade J., Gardiner 
J., Poverejan E. (2003). Treating depression in nursing homes: 
practice guidelines in the real world. J Am Osteopath Assoc. 
103(10), 465-469.
    \84\ Crespy S.D., Van Haitsma K., Kleban M., Hann C.J. Reducing 
Depressive Symptoms in Nursing Home Residents: Evaluation of the 
Pennsylvania Depression Collaborative Quality Improvement Program. J 
Healthc Qual. 2016. Vol. 38, No. 6, pp. e76-e88.
---------------------------------------------------------------------------

    In alignment with our Meaningful Measures Initiative, accurate 
assessment of cognitive function and mental status of patients and 
residents in PAC is expected to make care safer by reducing harm caused 
in the delivery of care; promote effective prevention and treatment of 
chronic disease; strengthen person and family engagement as partners in 
their care; and promote effective communication and coordination of 
care. For example, standardized assessment of cognitive function and 
mental status of patients and residents in PAC will support 
establishing a baseline for identifying changes in cognitive function 
and mental status (for example, delirium), anticipating the patient's 
or resident's ability to understand and participate in treatments 
during a PAC stay, ensuring patient and resident safety (for example, 
risk of falls), and identifying appropriate support needs at the time 
of discharge or transfer. Standardized patient assessment data elements 
will enable or support clinical decision-making and early clinical 
intervention; person-centered, high quality care through facilitating 
better care continuity and coordination; better data exchange and 
interoperability between settings; and longitudinal outcome analysis. 
Therefore, reliable standardized patient assessment data elements 
assessing cognitive function and mental status are needed in order to 
initiate a management program that can optimize a patient's or 
resident's prognosis and reduce the possibility of adverse events.
    The data elements related to cognitive function and mental status 
were first proposed as standardized patient assessment data elements in 
the FY 2018 SNF PPS proposed rule (82 FR 21060 through 21063). In 
response to our proposals, a few commenters noted that the proposed 
data elements did not capture some dimensions of cognitive function and 
mental status, such as functional cognition, communication, attention, 
concentration, and agitation. One commenter also suggested that other 
cognitive assessments should be considered for standardization. Another 
commenter stated support for the standardized assessment of cognitive 
function and mental status, because it could support appropriate use of 
skilled therapy for beneficiaries with degenerative conditions, such as 
dementia, and appropriate use of medications for behavioral and 
psychological symptoms of dementia.
    We are inviting comment on our proposals to collect as standardized 
patient assessment data the following data with respect to cognitive 
function and mental status.

 Brief Interview for Mental Status (BIMS)

    We are proposing that the data elements that comprise the BIMS meet 
the definition of standardized patient assessment data with respect to 
cognitive function and mental status under section 1899B(b)(1)(B)(ii) 
of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21060 
through 21061), dementia and cognitive impairment are associated with 
long-term functional dependence and, consequently, poor quality of life 
and increased health care costs and mortality.\85\ This makes 
assessment of mental status and early detection of cognitive decline or 
impairment critical in the PAC setting. The intensity of routine 
nursing care is higher for patients and residents with cognitive 
impairment than those without, and dementia is a significant variable 
in predicting readmission after discharge to the community from PAC 
providers.\86\
---------------------------------------------------------------------------

    \85\ Ag[uuml]ero-Torres, H., Fratiglioni, L., Guo, Z., Viitanen, 
M., von Strauss, E., & Winblad, B. (1998). ``Dementia is the major 
cause of functional dependence in the elderly: 3-year follow-up data 
from a population-based study.'' Am J of Public Health 88(10): 1452-
1456.
    \86\ RTI International. Proposed Measure Specifications for 
Measures Proposed in the FY 2017 IRF QRP NPRM. Research Triangle 
Park, NC. 2016.
---------------------------------------------------------------------------

    The BIMS is a performance-based cognitive assessment screening tool 
that assesses repetition, recall with and without prompting, and 
temporal orientation. The data elements that make up the BIMS are seven 
questions on the repetition of three words, temporal orientation, and 
recall that result in a cognitive function score. The BIMS was 
developed to be a brief, objective screening tool, with a focus on 
learning and memory. As a brief screener, the BIMS was not designed to 
diagnose dementia or cognitive impairment, but rather to be a 
relatively quick and easy to score assessment that could identify 
cognitively impaired patients as well as those who may be at risk for 
cognitive decline and require further assessment. It is currently in 
use in two of the PAC assessments: The MDS used by SNFs and the IRF-PAI 
used by IRFs. For more information on the BIMS, we refer readers to the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/

[[Page 17646]]

IMPACT-Act-Downloads-and-Videos.html.
    The data elements that comprise the BIMS were first proposed as 
standardized patient assessment data elements in the FY 2018 SNF PPS 
proposed rule (82 FR 21060 through 21061). In that proposed rule, we 
stated that the proposal was informed by input we received through a 
call for input published on the CMS Measures Management System 
Blueprint website. Input submitted from August 12 to September 12, 2016 
expressed support for use of the BIMS, noting that it is reliable, 
feasible to use across settings, and will provide useful information 
about patients and residents. We also stated that the data collected 
through the BIMS will provide a clearer picture of patient or resident 
complexity, help with the care planning process, and be useful during 
care transitions and when coordinating across providers. A summary 
report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, a 
few commenters supported the use of the BIMS as standardized patient 
assessment data elements. Other commenters were critical of the BIMS, 
noting its limitations for assessing mild cognitive impairment and 
functional cognition. Another stated that the BIMS should be 
administered with respect to discharge, as well as admission to capture 
changes during the stay. One expressed concern that the BIMS cannot be 
completed by patients and residents who are unable to communicate.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
BIMS was included in the National Beta Test of candidate data elements 
conducted by our data element contractor from November 2017 to August 
2018. Results of this test found the BIMS to be feasible and reliable 
for use with PAC patients and residents. More information about the 
performance of the BIMS in the National Beta Test can be found in the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the proposed 
standardized patient assessment data elements and the TEP supported the 
assessment of patient or resident cognitive status at both admission 
and discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. Some commenters also expressed concern that the BIMS, if used 
alone, may not be sensitive enough to capture the range of cognitive 
impairments, including mild cognitive impairment (MCI). A summary of 
the public input received from the November 27, 2018 stakeholder 
meeting titled ``Input on Standardized Patient Assessment Data Elements 
(SPADEs) Received After November 27, 2018 Stakeholder Meeting'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We understand the concerns raised by stakeholders that BIMS, if 
used alone, may not be sensitive enough to capture the range of 
cognitive impairments, including functional cognition and MCI, but note 
that the purpose of the BIMS data elements as SPADEs is to screen for 
cognitive impairment in a broad population. We also acknowledge that 
further cognitive tests may be required based on a patient's condition 
and will take this feedback into consideration in the development of 
future standardized assessment data elements. However, taking together 
the importance of assessing for cognitive status, stakeholder input, 
and strong test results, we are proposing that the BIMS data elements 
meet the definition of standardized patient assessment data with 
respect to cognitive function and mental status under section 
1899B(b)(1)(B)(ii) of the Act and to adopt the BIMS as standardized 
patient assessment data for use in the SNF QRP.

 Confusion Assessment Method (CAM)

    We are proposing that the data elements that comprise the Confusion 
Assessment Method (CAM) meet the definition of standardized patient 
assessment data with respect to cognitive function and mental status 
under section 1899B(b)(1)(B)(ii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21061), 
the CAM was developed to identify the signs and symptoms of delirium. 
It results in a score that suggests whether a patient or resident 
should be assigned a diagnosis of delirium. Because patients and 
residents with multiple comorbidities receive services from PAC 
providers, it is important to assess delirium, which is associated with 
a high mortality rate and prolonged duration of stay in hospitalized 
older adults.\87\ Assessing these signs and symptoms of delirium is 
clinically relevant for care planning by PAC providers.
---------------------------------------------------------------------------

    \87\ Fick, D.M., Steis, M.R., Waller, J.L., & Inouye, S.K. 
(2013). ``Delirium superimposed on dementia is associated with 
prolonged length of stay and poor outcomes in hospitalized older 
adults.'' J of Hospital Med 8(9): 500-505.
---------------------------------------------------------------------------

    The CAM is a patient assessment that screens for overall cognitive 
impairment, as well as distinguishes delirium or reversible confusion 
from other types of cognitive impairment. The CAM is currently in use 
in two of the PAC assessments: A four-item version of the CAM is used 
in the MDS in SNFs and a six-item version of the CAM is used in the 
LTCH CARE Data Set (LCDS) in LTCHs. We are proposing the four-item 
version of the CAM that assesses acute change in mental status, 
inattention, disorganized thinking, and altered level of consciousness. 
For more information on the CAM, we refer readers to the document 
titled ``Proposed Specifications for SNF QRP Quality Measures and 
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The data elements that comprise the CAM were first proposed as 
standardized patient assessment data

[[Page 17647]]

elements in the FY 2018 SNF PPS proposed rule (82 FR 21061). In that 
proposed rule, we stated that the proposal was informed by input we 
received on the CAM through a call for input published on the CMS 
Measures Management System Blueprint website. Input submitted from 
August 12 to September 12, 2016 expressed support for use of the CAM, 
noting that it would provide important information for care planning 
and care coordination and, therefore, contribute to quality 
improvement. We also stated that those commenters had noted the CAM is 
particularly helpful in distinguishing delirium and reversible 
confusion from other types of cognitive impairment. A summary report 
for the August 12 to September 12, 2016 public comment period titled 
``SPADE August 2016 Public Comment Summary Report'' is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, a 
few commenters supported the use of the CAM as standardized patient 
assessment data elements, with one noting that it distinguishes 
delirium or reversible confusion from other types of cognitive 
impairments to share across settings for care coordination.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
CAM was included in the National Beta Test of candidate data elements 
conducted by our data element contractor from November 2017 to August 
2018. Results of this test found the CAM to be feasible and reliable 
for use with PAC patients and residents. More information about the 
performance of the CAM in the National Beta Test can be found in the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although they did not 
specifically discuss the CAM data elements, the TEP supported the 
assessment of patient or resident cognitive status with respect to both 
admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for delirium, 
stakeholder input, and strong test results, we are proposing that the 
CAM data elements meet the definition of standardized patient 
assessment data with respect to cognitive function and mental status 
under section 1899B(b)(1)(B)(ii) of the Act and to adopt the CAM as 
standardized patient assessment data elements for use in the SNF QRP.
b. Patient Health Questionnaire--2 to 9 (PHQ-2 to 9)
    We are proposing that the Patient Health Questionnaire--2 to 9 
(PHQ-2 to 9) data elements meet the definition of standardized patient 
assessment data with respect to cognitive function and mental status 
under section 1899B(b)(1)(B)(ii) of the Act. The proposed data elements 
are based on the PHQ-2 mood interview, which focuses on only the two 
cardinal symptoms of depression, and the longer PHQ-9 mood interview, 
which assesses presence and frequency of nine signs and symptoms of 
depression. The name of the data element, the PHQ-2 to 9, refers to an 
embedded a skip pattern that transitions residents with a threshold 
level of symptoms in the PHQ-2 to the longer assessment of the PHQ-9. 
The skip pattern is described further below.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21062 
through 21063), depression is a common and under-recognized mental 
health condition. Assessments of depression help PAC providers better 
understand the needs of their patients and residents by: Prompting 
further evaluation after establishing a diagnosis of depression; 
elucidating the patient's or resident's ability to participate in 
therapies for conditions other than depression during their stay; and 
identifying appropriate ongoing treatment and support needs at the time 
of discharge.
    The proposed PHQ-2 to 9 is based on the PHQ-9 mood interview. The 
PHQ-2 consists of questions about only the first two symptoms addressed 
in the PHQ-9: Depressed mood and anhedonia (inability to feel 
pleasure), which are the cardinal symptoms of depression. The PHQ-2 has 
performed well as both a screening tool for identifying depression, to 
assess depression severity, and to monitor patient mood over 
time.88 89 If a patient demonstrates signs of depressed mood 
and anhedonia under the PHQ-2, then the patient is administered the 
lengthier PHQ-9. This skip pattern (also referred to as a gateway) is 
designed to reduce the length of the interview assessment for residents 
who fail to report the cardinal symptoms of depression. The design of 
the PHQ-2 to 9 reduces the burden that would be associated with the 
full PHQ-9, while ensuring that patients with indications of depressive 
symptoms based on the PHQ-2 receive the longer assessment.
---------------------------------------------------------------------------

    \88\ Li, C., Friedman, B., Conwell, Y., & Fiscella, K. (2007). 
``Validity of the Patient Health Questionnaire 2 (PHQ-2) in 
identifying major depression in older people.'' J of the A 
Geriatrics Society, 55(4): 596-602.
    \89\ L[ouml]we, B., Kroenke, K., & Gr[auml]fe, K. (2005). 
``Detecting and monitoring depression with a two-item questionnaire 
(PHQ-2).'' J of Psychosomatic Research, 58(2): 163-171.
---------------------------------------------------------------------------

    Components of the proposed data elements are currently used in the 
OASIS for HHAs (PHQ-2) and the MDS for SNFs (PHQ-9). We are proposing 
altering the administration instructions for the existing data elements 
to adopt the PHQ-2 to 9 gateway logic, meaning that administration of 
the full PHQ-9 is contingent on resident responses to questions about 
the cardinal symptoms of depression. For more information on the PHQ-2 
to 9, we refer readers to the document titled ``Proposed Specifications 
for SNF QRP Quality Measures and Standardized Patient Assessment Data 
Elements,'' available at https://www.cms.gov/Medicare/Quality-

[[Page 17648]]

Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The PHQ-2 data elements were first proposed as SPADEs in the FY 
2018 SNF PPS proposed rule (82 FR 21062 through 21063). In that 
proposed rule we stated that the proposal was informed by input we 
received from the TEP convened by our data element contractor on April 
6 and 7, 2016. The TEP members particularly noted that the brevity of 
the PHQ-2 made it feasible to administer with low burden for both 
assessors and PAC patients or residents. A summary of the April 6 and 
7, 2016 TEP meeting titled ``SPADE Technical Expert Panel Summary 
(First Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. That proposed rule was also informed by public input 
through a call for input published on the CMS Measures Management 
System Blueprint website. Input was submitted from August 12 to 
September 12, 2016 on three versions of the PHQ depression screener: 
The PHQ-2; the PHQ-9; and the PHQ-2 to 9 with the skip pattern design. 
Many commenters provided feedback on using the PHQ-2 for the assessment 
of mood. Overall, commenters believed that collecting these data 
elements across PAC provider types was appropriate, given the role that 
depression plays in well-being. Several commenters expressed support 
for an approach that would use PHQ-2 as a gateway to the longer PHQ-9 
while still potentially reducing burden on most patients and residents, 
as well as test administrators, and ensuring the administration of the 
PHQ-9, which exhibits higher specificity,\90\ for patients and 
residents who showed signs and symptoms of depression on the PHQ-2. A 
summary report for the August 12 to September 12, 2016 public comment 
period titled ``SPADE August 2016 Public Comment Summary Report'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \90\ Arroll B., Goodyear-Smith F., Crengle S., Gunn J., Kerse 
N., Fishman T., et al. Validation of PHQ-2 and PHQ-9 to screen for 
major depression in the primary care population. Annals of family 
medicine. 2010;8(4):348-353. doi: 10.1370/afm.1139 pmid:20644190; 
PubMed Central PMCID: PMC2906530.
---------------------------------------------------------------------------

    In response to our proposal to use the PHQ-2 in the FY 2018 SNF PPS 
proposed rule, a few commenters supported screening residents for 
depression with the PHQ-2. One commenter opposed the replacement of the 
PHQ-9 on the MDS with PHQ-2 because of the clinical significance of 
depression on quality of care and resident outcomes in the SNF 
population. Another expressed concern about the use of multi-step 
``gateway'' questions, because use of the PHQ-2 and PHQ-9 may result in 
data not being standardized across settings and providers gathering 
data unrelated to the appropriateness of care.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
PHQ-2 to 9 was included in the National Beta Test of candidate data 
elements conducted by our data element contractor from November 2017 to 
August 2018. Results of this test found the PHQ-2 to 9 to be feasible 
and reliable for use with PAC patients and residents. More information 
about the performance of the PHQ-2 to 9 in the National Beta Test can 
be found in the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the PHQ-2 to 
9. The TEP was supportive of the PHQ-2 to 9 data element set as a 
screener for signs and symptoms of depression. The TEP's discussion 
noted that symptoms evaluated by the full PHQ-9 (for example, 
concentration, sleep, appetite) had relevance to care planning and the 
overall well-being of the patient or resident, but that the gateway 
approach of the PHQ-2 to 9 would be appropriate as a depression 
screening assessment, as it depends on the well-validated PHQ-2 and 
focuses on the cardinal symptoms of depression. A summary of the 
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel 
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for depression, 
stakeholder input, and strong test results, we are proposing that the 
PHQ-2 to 9 data elements meet the definition of standardized patient 
assessment data with respect to cognitive function and mental status 
under section 1899B(b)(1)(B)(ii) of the Act and to adopt the PHQ-2 to 9 
data elements as standardized patient assessment data elements for use 
in the SNF QRP.
c. Special Services, Treatments, and Interventions Data
    Special services, treatments, and interventions performed in PAC 
can have a major effect on an individual's health status, self-image, 
and quality of life. The assessment of these special services, 
treatments, and interventions in PAC is important to ensure the 
continuing appropriateness of care for the patients and residents 
receiving them, and to support care transitions from one PAC provider 
to another, an acute care hospital, or discharge. In alignment with our 
Meaningful Measures Initiative, accurate assessment of special 
services, treatments, and interventions of patients and residents 
served by PAC providers is expected to make care safer by reducing harm 
caused in the delivery of care; promote effective prevention and 
treatment of chronic disease; strengthen person and family engagement 
as partners in their care; and promote effective communication and 
coordination of care.
    For example, standardized assessment of special services, 
treatments, and

[[Page 17649]]

interventions used in PAC can promote patient and resident safety 
through appropriate care planning (for example, mitigating risks such 
as infection or pulmonary embolism associated with central intravenous 
access), and identifying life-sustaining treatments that must be 
continued, such as mechanical ventilation, dialysis, suctioning, and 
chemotherapy, at the time of discharge or transfer. Standardized 
assessment of these data elements will enable or support: Clinical 
decision-making and early clinical intervention; person-centered, high 
quality care through, for example, facilitating better care continuity 
and coordination; better data exchange and interoperability between 
settings; and longitudinal outcome analysis. Therefore, reliable data 
elements assessing special services, treatments, and interventions are 
needed to initiate a management program that can optimize a patient's 
or resident's prognosis and reduce the possibility of adverse events.
    A TEP convened by our data element contractor provided input on all 
of the proposed data elements for special services, treatments, and 
interventions. In a meeting held on January 5 and 6, 2017, this TEP 
found that these data elements are appropriate for standardization 
because they would provide useful clinical information to inform care 
planning and care coordination. The TEP affirmed that assessment of 
these services and interventions is standard clinical practice, and 
that the collection of these data by means of a list and checkbox 
format would conform with common workflow for PAC providers. A summary 
of the January 5 and 6, 2017 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Second Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Comments on the category of special services, treatments, and 
interventions were also submitted by stakeholders during the FY 2018 
SNF PPS proposed rule (82 FR 21063 through 21073) public comment 
period. A comment across all special services, treatments, and 
interventions data elements requested that the additional reporting 
burden of the special services, treatments, and interventions data 
elements be addressed in payment calculations. Another comment 
submitted for several special services, treatments, and interventions 
data elements requested additional time be allowed before the providers 
are required to submit these data. One commenter expressed concern 
about increased reporting burden of the data elements proposed in FY 
2018 because they would require an additional look-back time frame. 
Several commenters supported the inclusion of nutritional data elements 
as standardized data elements noting their importance in capturing 
information on care coordination and safe care transitions. One 
commenter noted the limitations of the nutritional data elements, 
namely that they do not capture information on swallowing or the 
clinical rationale for feeding/nutrition needs.
    Information on data element performance in the National Beta Test, 
which collected data between November 2017 and August 2018, is reported 
within each data element proposal below. Clinical staff who 
participated in the National Beta Test supported these data elements 
because of their importance in conveying patient or resident 
significant health care needs, complexity, and progress. However, 
clinical staff also noted that, despite the simple ``check box'' format 
of these data element, they sometimes needed to consult multiple 
information sources to determine a patient's or resident's treatments.
    We are inviting comment on our proposals to collect as standardized 
patient assessment data the following data with respect to special 
services, treatments, and interventions.
(1) Cancer Treatment: Chemotherapy (IV, Oral, Other)
    We are proposing that the Chemotherapy (IV, Oral, Other) data 
element meets the definition of standardized patient assessment data 
with respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21063 
through 21064), chemotherapy is a type of cancer treatment that uses 
drugs to destroy cancer cells. It is sometimes used when a patient has 
a malignancy (cancer), which is a serious, often life-threatening or 
life-limiting condition. Both intravenous (IV) and oral chemotherapy 
have serious side effects, including nausea/vomiting, extreme fatigue, 
risk of infection due to a suppressed immune system, anemia, and an 
increased risk of bleeding due to low platelet counts. Oral 
chemotherapy can be as potent as chemotherapy given by IV, and can be 
significantly more convenient and less resource-intensive to 
administer. Because of the toxicity of these agents, special care must 
be exercised in handling and transporting chemotherapy drugs. IV 
chemotherapy is administered either peripherally, or more commonly, 
given via an indwelling central line, which raises the risk of 
bloodstream infections. Given the significant burden of malignancy, the 
resource intensity of administering chemotherapy, and the side effects 
and potential complications of these highly-toxic medications, 
assessing the receipt of chemotherapy is important in the PAC setting 
for care planning and determining resource use. The need for 
chemotherapy predicts resource intensity, both because of the 
complexity of administering these potent, toxic drug combinations under 
specific protocols, and because of what the need for chemotherapy 
signals about the patient's underlying medical condition. Furthermore, 
the resource intensity of IV chemotherapy is higher than for oral 
chemotherapy, as the protocols for administration and the care of the 
central line (if present) for IV chemotherapy require significant 
resources.
    The Chemotherapy (IV, Oral, Other) data element consists of a 
principal data element (Chemotherapy) and three response option sub-
elements: IV chemotherapy, which is generally resource-intensive; Oral 
chemotherapy, which is less invasive and generally requires less 
intensive administration protocols; and a third category, Other, 
provided to enable the capture of other less common chemotherapeutic 
approaches. This third category is potentially associated with higher 
risks and is more resource intensive due to chemotherapy delivery by 
other routes (for example, intraventricular or intrathecal). If the 
assessor indicates that the resident is receiving chemotherapy on the 
principal Chemotherapy data element, the assessor would then indicate 
by which route or routes (for example, IV, Oral, Other) the 
chemotherapy is administered.
    A single Chemotherapy data element that does not include the 
proposed three sub-elements is currently in use in the MDS in SNFs. We 
are proposing to expand the existing Chemotherapy data element in the 
MDS to include sub-elements for IV, Oral, and Other. For more 
information on the Chemotherapy (IV, Oral, Other) data element, we 
refer readers to the document titled ``Proposed Specifications for SNF 
QRP Quality Measures and Standardized Patient Assessment Data 
Elements,'' available at https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/Post-Acute-

[[Page 17650]]

Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-
Videos.html.
    The Chemotherapy data element was first proposed as a standardized 
patient assessment data element in the FY 2018 SNF PPS proposed rule 
(82 FR 21063 through 21064). In that proposed rule, we stated that the 
proposal was informed by input we received through a call for input 
published on the CMS Measures Management System Blueprint website. 
Input submitted from August 12 to September 12, 2016 expressed support 
for the IV Chemotherapy data element and suggested it be included as 
standardized patient assessment data. We also stated that those 
commenters had noted that assessing the use of chemotherapy services is 
relevant to share across the care continuum to facilitate care 
coordination and care transitions and noted the validity of the data 
element. Commenters also noted the importance of capturing all types of 
chemotherapy, regardless of route, and stated that collecting data only 
on patients and residents who received chemotherapy by IV would limit 
the usefulness of this standardized data element. A summary report for 
the August 12 to September 12, 2016 public comment period titled 
``SPADE August 2016 Public Comment Summary Report'' is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of Chemotherapy (IV, Oral, Other) 
as standardized patient assessment data elements.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Chemotherapy data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the 
Chemotherapy data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
Chemotherapy data element in the National Beta Test can be found in the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP members 
did not specifically discuss the Chemotherapy data element, the TEP 
members supported the assessment of the special services, treatments, 
and interventions included in the National Beta Test with respect to 
both admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for chemotherapy, 
stakeholder input, and strong test results, we are proposing, we are 
proposing that the Chemotherapy (IV, Oral, Other) data element with a 
principal data element and three sub-elements meet the definition of 
standardized patient assessment data with respect to special services, 
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act and to adopt the Chemotherapy (IV, Oral, Other) data element as 
standardized patient assessment data for use in the SNF QRP.
(2) Cancer Treatment: Radiation
    We are proposing that the Radiation data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21064 
through 21065), radiation is a type of cancer treatment that uses high-
energy radioactivity to stop cancer by damaging cancer cell DNA, but it 
can also damage normal cells. Radiation is an important therapy for 
particular types of cancer, and the resource utilization is high, with 
frequent radiation sessions required, often daily for a period of 
several weeks. Assessing whether a patient or resident is receiving 
radiation therapy is important to determine resource utilization 
because PAC patients and residents will need to be transported to and 
from radiation treatments, and monitored and treated for side effects 
after receiving this intervention. Therefore, assessing the receipt of 
radiation therapy, which would compete with other care processes given 
the time burden, would be important for care planning and care 
coordination by PAC providers.
    The proposed data element consists of the single Radiation data 
element. The Radiation data element is currently in use in the MDS in 
SNFs. For more information on the Radiation data element, we refer 
readers to the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Radiation data element was first proposed as a SPADE in the FY 
2018 SNF PPS proposed rule (82 FR 21064 through 21065). In that 
proposed rule, we stated that the proposal was informed by input we 
received through a call for input published on the CMS Measures 
Management System Blueprint website. Input submitted from August 12 to 
September 12, 2016, expressed support for the Radiation data element, 
noting its importance and clinical usefulness for patients and 
residents in PAC settings, due to the side effects and consequences of 
radiation treatment on patients and residents that need to be 
considered in care planning and care transitions, the feasibility of 
the item, and the potential for it to improve quality. A summary

[[Page 17651]]

report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of Radiation as a standardized 
patient assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Radiation data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the Radiation 
data element to be feasible and reliable for use with PAC patients and 
residents. More information about the performance of the Radiation data 
element in the National Beta Test can be found in the document titled 
``Proposed Specifications for SNF QRP Quality Measures and Standardized 
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP members 
did not specifically discuss the Radiation data element, the TEP 
members supported the assessment of the special services, treatments, 
and interventions included in the National Beta Test with respect to 
both admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present results of the National Beta 
Test and solicit additional comments. General input on the testing and 
item development process and concerns about burden were received from 
stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for radiation, 
stakeholder input, and strong test results, we are proposing that the 
Radiation data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt 
the Radiation data element as standardized patient assessment data for 
use in the SNF QRP.
(3) Respiratory Treatment: Oxygen Therapy (Intermittent, Continuous, 
High-Concentration Oxygen Delivery System)
    We are proposing that the Oxygen Therapy (Intermittent, Continuous, 
High-Concentration Oxygen Delivery System) data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21065), 
oxygen therapy provides a patient or resident with extra oxygen when 
medical conditions such as chronic obstructive pulmonary disease, 
pneumonia, or severe asthma prevent the patient or resident from 
getting enough oxygen from breathing. Oxygen administration is a 
resource-intensive intervention, as it requires specialized equipment 
such as a source of oxygen, delivery systems (for example, oxygen 
concentrator, liquid oxygen containers, and high-pressure systems), the 
patient interface (for example, nasal cannula or mask), and other 
accessories (for example, regulators, filters, tubing). The data 
element proposed here captures patient or resident use of three types 
of oxygen therapy (intermittent, continuous, and high-concentration 
oxygen delivery system), which reflects the intensity of care needed, 
including the level of monitoring and bedside care required. Assessing 
the receipt of this service is important for care planning and resource 
use for PAC providers.
    The proposed data element, Oxygen Therapy, consists of the 
principal Oxygen Therapy data element and three response option sub-
elements: Continuous (whether the oxygen was delivered continuously, 
typically defined as >=14 hours per day); Intermittent; or High-
concentration oxygen delivery system. Based on public comments and 
input from expert advisors about the importance and clinical usefulness 
of documenting the extent of oxygen use, we added a third sub-element, 
high-concentration oxygen delivery system, to the sub-elements, which 
previously included only intermittent and continuous. If the assessor 
indicates that the resident is receiving oxygen therapy on the 
principal oxygen therapy data element, the assessor then would indicate 
the type of oxygen the patient receives (for example, Continuous, 
Intermittent, High-concentration oxygen delivery system).
    These three proposed sub-elements were developed based on similar 
data elements that assess oxygen therapy, currently in use in the MDS 
in SNFs (``Oxygen Therapy''), previously used in the OASIS (``Oxygen 
(intermittent or continuous)''), and a data element tested in the PAC 
PRD that focused on intensive oxygen therapy (``High O2 Concentration 
Delivery System with FiO2 >40 percent''). For more information on the 
proposed Oxygen Therapy (Continuous, Intermittent, High-concentration 
oxygen delivery system) data element, we refer readers to the document 
titled ``Proposed Specifications for SNF QRP Quality Measures and 
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Oxygen Therapy (Continuous, Intermittent) data element was 
first proposed as standardized patient assessment data in the FY 2018 
SNF PPS proposed rule (82 FR 21065). In that proposed rule, we stated 
that the proposal was informed by input we received on the single data 
element, Oxygen (inclusive of intermittent and continuous oxygen use), 
through a call for input published on the CMS Measures Management 
System Blueprint website. Input submitted from August 12 to September 
12, 2016 expressed the importance of the Oxygen data element, noting 
feasibility of this item in PAC, and the relevance of it to

[[Page 17652]]

facilitating care coordination and supporting care transitions, but 
suggesting that the extent of oxygen use be documented. A summary 
report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, a 
few commenters supported the adoption of Oxygen Therapy (Continuous, 
Intermittent) as a standardized patient assessment data element. 
Another commenter recommended that an option for high-concentration 
oxygen be added. In response to public comments, we added a third sub-
element for ``High-Concentration Oxygen Delivery System'' to the Oxygen 
Therapy data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Oxygen Therapy data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the Oxygen 
Therapy data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
Oxygen Therapy data element in the National Beta Test can be found in 
the document titled ``Proposed Specifications for SNF QRP Quality 
Measures and Standardized Patient Assessment Data Elements,'' available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Oxygen Therapy data element, the TEP supported 
the assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing oxygen therapy, 
stakeholder input, and strong test results, we are proposing that the 
Oxygen Therapy (Continuous, Intermittent, High-concentration Oxygen 
Delivery System) data element with a principal data element and three 
sub-elements meets the definition of standardized patient assessment 
data with respect to special services, treatments, and interventions 
under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Oxygen 
Therapy (Continuous, Intermittent, High-concentration Oxygen Delivery 
System) data element as standardized patient assessment data for use in 
the SNF QRP.
(4) Respiratory Treatment: Suctioning (Scheduled, as Needed)
    We are proposing that the Suctioning (Scheduled, As needed) data 
element meets the definition of standardized patient assessment data 
with respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21065 
through 21066), suctioning is a process used to clear secretions from 
the airway when a person cannot clear those secretions on his or her 
own. It is done by aspirating secretions through a catheter connected 
to a suction source. Types of suctioning include oropharyngeal and 
nasopharyngeal suctioning, nasotracheal suctioning, and suctioning 
through an artificial airway such as a tracheostomy tube. Oropharyngeal 
and nasopharyngeal suctioning are a key part of many patients' care 
plans, both to prevent the accumulation of secretions than can lead to 
aspiration pneumonias (a common condition in patients and residents 
with inadequate gag reflexes), and to relieve obstructions from mucus 
plugging during an acute or chronic respiratory infection, which often 
lead to desaturations and increased respiratory effort. Suctioning can 
be done on a scheduled basis if the patient is judged to clinically 
benefit from regular interventions, or can be done as needed when 
secretions become so prominent that gurgling or choking is noted, or a 
sudden desaturation occurs from a mucus plug. As suctioning is 
generally performed by a care provider rather than independently, this 
intervention can be quite resource intensive if it occurs every hour, 
for example, rather than once a shift. It also signifies an underlying 
medical condition that prevents the patient from clearing his/her 
secretions effectively (such as after a stroke, or during an acute 
respiratory infection). Generally, suctioning is necessary to ensure 
that the airway is clear of secretions which can inhibit successful 
oxygenation of the individual. The intent of suctioning is to maintain 
a patent airway, the loss of which can lead to death or complications 
associated with hypoxia.
    The Suctioning (Scheduled, As needed) data element consists of a 
principal data element, and two sub-elements: Scheduled; and As needed. 
These sub-elements capture two types of suctioning. Scheduled indicates 
suctioning based on a specific frequency, such as every hour; As needed 
means suctioning only when indicated. If the assessor indicates that 
the resident is receiving suctioning on the principal Suctioning data 
element, the assessor would then indicate the frequency (for example, 
Scheduled, As needed). The proposed data element is based on an item 
currently in use in the MDS in SNFs which does not include our proposed 
two sub-elements, as well as data elements tested in the PAC PRD that 
focused on the frequency of suctioning required for patients with 
tracheostomies (``Trach Tube with Suctioning: Specify most intensive 
frequency of suctioning during stay [Every __hours]''). We are 
proposing to expand the existing Suctioning data element on the MDS to 
include sub-elements for Scheduled and As Needed. For more information 
on the Suctioning data element, we refer readers to the document titled 
``Proposed Specifications for SNF QRP Quality Measures and Standardized 
Patient

[[Page 17653]]

Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Suctioning data element was first proposed as standardized 
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 
21065 through 21066). In that proposed rule, we stated that the 
proposal was informed by input we received on the Suctioning data 
element currently included in the MDS in SNFs through a call for input 
published on the CMS Measures Management System Blueprint website. 
Input submitted from August 12 to September 12, 2016 expressed support 
for this data element. The input noted the feasibility of this item in 
PAC, and the relevance of this data element to facilitating care 
coordination and supporting care transitions. We also stated that those 
commenters had suggested that we examine the frequency of suctioning to 
better understand the use of staff time, the impact on a patient or 
resident's capacity to speak and swallow, and intensity of care 
required. Based on these comments, we decided to add two sub-elements 
(Scheduled and As needed) to the suctioning element. The proposed 
Suctioning data element includes both the principal Suctioning data 
element that is included on the MDS in SNFs and two sub-elements, 
Scheduled and As needed. A summary report for the August 12 to 
September 12, 2016 public comment period titled ``SPADE August 2016 
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of Suctioning (Scheduled, As 
needed) as a standardized patient assessment data element. One 
commenter objected to ``scheduled'' suctioning as a response option due 
to a clinical practice guideline recommendation that suctioning should 
only be performed when clinically indicated and not on a scheduled 
basis.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Suctioning data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the Suctioning 
data element to be feasible and reliable for use with PAC patients and 
residents. More information about the performance of the Suctioning 
data element in the National Beta Test can be found in the document 
titled ``Proposed Specifications for SNF QRP Quality Measures and 
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Suctioning data element, the TEP supported the 
assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicited additional comments. General input on the 
testing and item development process and concerns about burden were 
received from stakeholders during this meeting and via email through 
February 1, 2019. A summary of the public input received from the 
November 27, 2018 stakeholder meeting titled ``Input on Standardized 
Patient Assessment Data Elements (SPADEs) Received After November 27, 
2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for suctioning, 
stakeholder input, and strong test results, we are proposing that the 
Suctioning (Scheduled, As needed) data element with a principal data 
element and two sub-elements meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to 
adopt the Suctioning (Scheduled, As needed) data element as 
standardized patient assessment data for use in the SNF QRP.
(5) Respiratory Treatment: Tracheostomy Care
    We are proposing that the Tracheostomy Care data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21066 
through 21067), a tracheostomy provides an air passage to help a 
patient or resident breathe when the usual route for breathing is 
obstructed or impaired. Generally, in all of these cases, suctioning is 
necessary to ensure that the tracheostomy is clear of secretions, which 
can inhibit successful oxygenation of the individual. Often, 
individuals with tracheostomies are also receiving supplemental 
oxygenation. The presence of a tracheostomy, albeit permanent or 
temporary, warrants careful monitoring and immediate intervention if 
the tracheostomy becomes occluded or if the device used becomes 
dislodged. While in rare cases the presence of a tracheostomy is not 
associated with increased care demands (and in some of those instances, 
the care of the ostomy is performed by the patient) in general the 
presence of such as device is associated with increased patient risk, 
and clinical care services will necessarily include close monitoring to 
ensure that no life-threatening events occur as a result of the 
tracheostomy. In addition, tracheostomy care, which primarily consists 
of cleansing, dressing changes, and replacement of the tracheostomy 
cannula (tube), is a critical part of the care plan. Regular cleansing 
is important to prevent infection such as pneumonia, and to prevent any 
occlusions with which there are risks for inadequate oxygenation.
    The proposed data element consists of the single Tracheostomy Care 
data element. The proposed data element is currently in use in the MDS 
in SNFs (``Tracheostomy care''). For more information on the 
Tracheostomy Care data element, we refer readers to the document titled 
``Proposed Specifications for SNF QRP Quality

[[Page 17654]]

Measures and Standardized Patient Assessment Data Elements,'' available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Tracheostomy Care data element was first proposed as 
standardized patient assessment data in the FY 2018 SNF PPS proposed 
rule (82 FR 21066 through 21067). In that proposed rule, we stated that 
the proposal was informed by input we received on the Tracheostomy Care 
data element through a call for input published on the CMS Measures 
Management System Blueprint website. Input submitted from August 12 to 
September 12, 2016, supported this data element, noting the feasibility 
of this item in PAC, and the relevance of this data element to 
facilitating care coordination and supporting care transitions. A 
summary report for the August 12 to September 12, 2016 public comment 
period titled ``SPADE August 2016 Public Comment Summary Report'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
we received a few comments in support of the adoption of Tracheostomy 
Care as a standardized patient assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Tracheostomy Care data element was included in the National Beta Test 
of candidate data elements conducted by our data element contractor 
from November 2017 to August 2018. Results of this test found the 
Tracheostomy Care data element to be feasible and reliable for use with 
PAC patients and residents. More information about the performance of 
the Tracheostomy Care data element in the National Beta Test can be 
found in the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Tracheostomy Care data element, the TEP 
supported the assessment of the special services, treatments, and 
interventions included in the National Beta Test with respect to both 
admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for tracheostomy care, 
stakeholder input, and strong test results, we are proposing that the 
Tracheostomy Care data element meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to 
adopt the Tracheostomy Care data element as standardized patient 
assessment data for use in the SNF QRP.
(6) Respiratory Treatment: Non-Invasive Mechanical Ventilator (BiPAP, 
CPAP)
    We are proposing that the Non-invasive Mechanical Ventilator 
(Bilevel Positive Airway Pressure [BiPAP], Continuous Positive Airway 
Pressure [CPAP]) data element meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21067), 
BiPAP and CPAP are respiratory support devices that prevent the airways 
from closing by delivering slightly pressurized air via electronic 
cycling throughout the breathing cycle (BiPAP) or through a mask 
continuously (CPAP). Assessment of non-invasive mechanical ventilation 
is important in care planning, as both CPAP and BiPAP are resource-
intensive (although less so than invasive mechanical ventilation) and 
signify underlying medical conditions about the patient or resident who 
requires the use of this intervention. Particularly when used in 
settings of acute illness or progressive respiratory decline, 
additional staff (for example, respiratory therapists) are required to 
monitor and adjust the CPAP and BiPAP settings and the patient or 
resident may require more nursing resources.
    The proposed data element, Non-invasive Mechanical Ventilator 
(BIPAP, CPAP), consists of the principal Non-invasive Mechanical 
Ventilator data element and two response option sub-elements: BiPAP and 
CPAP. If the assessor indicates that the resident is receiving non-
invasive mechanical ventilation on the principal Non-invasive 
Mechanical Ventilator data element, the assessor would then indicate 
which type (for example, BIPAP, CPAP). Data elements that assess non-
invasive mechanical ventilation are currently included on LCDS for the 
LTCH setting (``Non-invasive Ventilator (BIPAP, CPAP)''), and the MDS 
for the SNF setting (``Non-invasive Mechanical Ventilator (BiPAP/
CPAP)''). We are proposing to expand the existing BiPAP/CPAP data 
element on the MDS, retaining and relabeling the BiPAP/CPAP data 
element to be Non-invasive Mechanical Ventilator (BiPAP, CPAP), and 
adding two sub-elements for BiPAP and CPAP. For more information on the 
Non-invasive Mechanical Ventilator (BIPAP, CPAP) data element, we refer 
readers to the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Non-invasive Mechanical Ventilator data element was first 
proposed as standardized patient assessment data elements in the FY 
2018 SNF PPS proposed rule (82 FR 21067). In that proposed rule, we 
stated that the proposal was informed by input we received through a 
call for input

[[Page 17655]]

published on the CMS Measures Management System Blueprint website. 
Input submitted from August 12 to September 12, 2016 on a single data 
element, BiPAP/CPAP, that captures equivalent clinical information but 
uses a different label than the data element currently used in the MDS 
in SNFs and LCDS in LTCHs, expressed support for this data element, 
noting the feasibility of these items in PAC, and the relevance of this 
data element for facilitating care coordination and supporting care 
transitions. In addition, we also stated that some commenters supported 
separating out BiPAP and CPAP as distinct sub-elements, as they are 
therapies used for different types of patients and residents. A summary 
report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of Non-Invasive Mechanical 
Ventilator (BiPAP, CPAP) as a standardized patient assessment data 
element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Non-invasive Mechanical Ventilator data element was included in the 
National Beta Test of candidate data elements conducted by our data 
element contractor from November 2017 to August 2018. Results of this 
test found the Non-invasive Mechanical Ventilator data element to be 
feasible and reliable for use with PAC patients and residents. More 
information about the performance of the Non-invasive Mechanical 
Ventilator data element in the National Beta Test can be found in the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Non-invasive Mechanical Ventilator data 
element, the TEP supported the assessment of the special services, 
treatments, and interventions included in the National Beta Test with 
respect to both admission and discharge. A summary of the September 17, 
2018 TEP meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for non-invasive 
mechanical ventilation, stakeholder input, and strong test results, we 
are proposing that the Non-invasive Mechanical Ventilator (BiPAP, CPAP) 
data element with a principal data element and two sub-elements meets 
the definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act and to adopt the Non-invasive Mechanical 
Ventilator (BiPAP, CPAP) data element as standardized patient 
assessment data for use in the SNF QRP.
(7) Respiratory Treatment: Invasive Mechanical Ventilator
    We are proposing that the Invasive Mechanical Ventilator data 
element meets the definition of standardized patient assessment data 
with respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21067 
through 21068), invasive mechanical ventilation includes ventilators 
and respirators that ventilate the patient through a tube that extends 
via the oral airway into the pulmonary region or through a surgical 
opening directly into the trachea. Thus, assessment of invasive 
mechanical ventilation is important in care planning and risk 
mitigation. Ventilation in this manner is a resource-intensive therapy 
associated with life-threatening conditions without which the patient 
or resident would not survive. However, ventilator use has inherent 
risks requiring close monitoring. Failure to adequately care for the 
patient or resident who is ventilator dependent can lead to iatrogenic 
events such as death, pneumonia, and sepsis. Mechanical ventilation 
further signifies the complexity of the patient's underlying medical or 
surgical condition. Of note, invasive mechanical ventilation is 
associated with high daily and aggregate costs.\91\
---------------------------------------------------------------------------

    \91\ Wunsch, H., Linde-Zwirble, W. T., Angus, D. C., Hartman, M. 
E., Milbrandt, E. B., & Kahn, J. M. (2010). ``The epidemiology of 
mechanical ventilation use in the United States.'' Critical Care Med 
38(10): 1947-1953.
---------------------------------------------------------------------------

    The proposed data element, Invasive Mechanical Ventilator, consists 
of a single data element. Data elements that capture invasive 
mechanical ventilation are currently in use in the MDS in SNFs and LCDS 
in LTCHs. The MDS currently assesses invasive mechanical ventilation 
with the Ventilator or Respirator data element. We are proposing to 
rename this data element in the MDS to be Invasive Mechanical 
Ventilator. For more information on the Invasive Mechanical Ventilator 
data element, we refer readers to the document titled ``Proposed 
Specifications for SNF QRP Quality Measures and Standardized Patient 
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Invasive Mechanical Ventilator data element was first proposed 
as standardized patient assessment data in the FY 2018 SNF PPS proposed 
rule (82 FR 21067 through 21068). In that proposed rule, we stated that 
the proposal was informed by input we received through a call for input 
published on the CMS Measures Management System Blueprint website on 
data elements that assess invasive ventilator use and weaning status 
that were tested in the PAC PRD (``Ventilator--Weaning'' and 
``Ventilator--Non-Weaning''). Input submitted from August 12 to 
September 12, 2016 expressed support for this data

[[Page 17656]]

element, highlighting the importance of this information in supporting 
care coordination and care transitions. We also stated that some 
commenters had expressed concern about the appropriateness for 
standardization given: The prevalence of ventilator weaning across PAC 
providers; the timing of administration; how weaning is defined; and 
how weaning status in particular relates to quality of care. These 
public comments guided our decision to propose a single data element 
focused on current use of invasive mechanical ventilation only, which 
does not attempt to capture weaning status. A summary report for the 
August 12 to September 12, 2016 public comment period titled ``SPADE 
August 2016 Public Comment Summary Report'' we received is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, a 
few commenters supported the adoption of Invasive Mechanical Ventilator 
as a standardized patient assessment data element. One commenter stated 
that a data element to indicate ``weaning'' is important because it 
indicates higher resource utilization.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Invasive Mechanical Ventilator data element was included in the 
National Beta Test of candidate data elements conducted by our data 
element contractor from November 2017 to August 2018. Results of this 
test found the Invasive Mechanical Ventilator data element to be 
feasible and reliable for use with PAC patients and residents. More 
information about the performance of the Invasive Mechanical Ventilator 
data element in the National Beta Test can be found in the document 
titled ``Proposed Specifications for SNF QRP Quality Measures and 
Standardized Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Invasive Mechanical Ventilator data element, 
the TEP supported the assessment of the special services, treatments, 
and interventions included in the National Beta Test with respect to 
both admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present results of the National Beta 
Test and solicit additional comments. General input on the testing and 
item development process and concerns about burden were received from 
stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for invasive mechanical 
ventilation, stakeholder input, and strong test results, we are 
proposing that the Invasive Mechanical Ventilator data element that 
assesses the use of an invasive mechanical ventilator meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act and to adopt the Invasive Mechanical 
Ventilator data element as standardized patient assessment data for use 
in the SNF QRP.
(8) Intravenous (IV) Medications (Antibiotics, Anticoagulants, 
Vasoactive Medications, Other)
    We are proposing that the IV Medications (Antibiotics, 
Anticoagulants, Vasoactive Medications, Other) data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21068 
through 21069), when we proposed a similar data element related to IV 
medications, IV medications are solutions of a specific medication (for 
example, antibiotics, anticoagulants) administered directly into the 
venous circulation via a syringe or intravenous catheter. IV 
medications are administered via intravenous push, single, 
intermittent, or continuous infusion through a catheter placed into the 
vein. Further, IV medications are more resource intensive to administer 
than oral medications, and signify a higher patient complexity (and 
often higher severity of illness).
    The clinical indications for each of the sub-elements of the IV 
Medications data element (Antibiotics, Anticoagulants, Vasoactive 
Medications, and Other) are very different. IV antibiotics are used for 
severe infections when the bioavailability of the oral form of the 
medication would be inadequate to kill the pathogen or an oral form of 
the medication does not exist. IV anticoagulants refer to anti-clotting 
medications (that is, ``blood thinners''). IV anticoagulants are 
commonly used for hospitalized patients who have deep venous 
thrombosis, pulmonary embolism, or myocardial infarction, as well as 
those undergoing interventional cardiac procedures. Vasoactive 
medications refer to the IV administration of vasoactive drugs, 
including vasopressors, vasodilators, and continuous medication for 
pulmonary edema, which increase or decrease blood pressure or heart 
rate. The indications, risks, and benefits of each of these classes of 
IV medications are distinct, making it important to assess each 
separately in PAC. Knowing whether or not patients and residents are 
receiving IV medication and the type of medication provided by each PAC 
provider will improve quality of care.
    The IV Medications (Antibiotics, Anticoagulants, Vasoactive 
Medications, and Other) data element we are proposing consists of a 
principal data element (IV Medications) and four response option sub-
elements: Antibiotics, Anticoagulants, Vasoactive Medications, and 
Other. The Vasoactive Medications sub-element was not proposed in the 
FY 2018 SNF PPS proposed rule. We added the Vasoactive Medications sub-
element to our proposal in order to harmonize the proposed IV 
Medications element with the data currently collected in the LCDS.
    If the assessor indicates that the resident is receiving IV 
medications on the principal IV Medications data element, the assessor 
would then indicate which types of medications (for

[[Page 17657]]

example, Antibiotics, Anticoagulants, Vasoactive Medications, Other). 
An IV Medications data element is currently in use on the MDS in SNFs 
and there is a related data element in OASIS that collects information 
on Intravenous and Infusion Therapies. We are proposing to expand the 
existing IV Medications data element in the MDS to include sub-elements 
for Antibiotics, Anticoagulants, Vasoactive Medications, and Other. For 
more information on the IV Medications (Antibiotics, Anticoagulants, 
Vasoactive Medications, Other) data element, we refer readers to the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    An IV Medications data element was first proposed as SPADEs in the 
FY 2018 SNF PPS proposed rule (82 FR 21068 through 21069). In that 
proposed rule, we stated that the proposal was informed by input we 
received on Vasoactive Medications through a call for input published 
on the CMS Measures Management System Blueprint website. Input 
submitted from August 12 to September 12, 2016 supported this data 
element with one noting the importance of this data element in 
supporting care transitions. We also stated that those commenters had 
criticized the need for collecting specifically Vasoactive Medications, 
giving feedback that the data element was too narrowly focused. In 
addition, public comment received indicated that the clinical 
significance of vasoactive medications administration alone was not 
high enough in PAC to merit mandated assessment, noting that related 
and more useful information could be captured in an item that assessed 
all IV medication use. A summary report for the August 12 to September 
12, 2016 public comment period titled ``SPADE August 2016 Public 
Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of Intravenous (IV) Medications 
(Antibiotics, Anticoagulation, Other) as a standardized patient 
assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
IV Medications data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the IV 
Medications data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
IV Medications data element in the National Beta Test can be found in 
the document titled ``Proposed Specifications for SNF QRP Quality 
Measures and Standardized Patient Assessment Data Elements,'' available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the IV Medications data element, the TEP supported 
the assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for IV medications, 
stakeholder input, and strong test results, we are proposing that the 
IV Medications (Antibiotics, Anticoagulants, Vasoactive Medications, 
Other) data element with a principal data element and four sub-elements 
meets the definition of standardized patient assessment data with 
respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act and to adopt the IV Medications 
(Antibiotics, Anticoagulants, Vasoactive Medications, Other) data 
element as standardized patient assessment data for use in the SNF QRP.
(9) Transfusions
    We are proposing that the Transfusions data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21069), 
transfusion refers to introducing blood or blood products into the 
circulatory system of a person. Blood transfusions are based on 
specific protocols, with multiple safety checks and monitoring required 
during and after the infusion in case of adverse events. Coordination 
with the provider's blood bank is necessary, as well as documentation 
by clinical staff to ensure compliance with regulatory requirements. In 
addition, the need for transfusions signifies underlying patient 
complexity that is likely to require care coordination and patient 
monitoring, and impacts planning for transitions of care, as 
transfusions are not performed by all PAC providers.
    The proposed data element consists of the single Transfusions data 
element. A data element on transfusion is currently in use in the MDS 
in SNFs (``Transfusions'') and a data element tested in the PAC PRD 
(``Blood Transfusions'') was found feasible for use in each of the four 
PAC settings. For more information on the Transfusions data element, we 
refer readers to the document titled ``Proposed Specifications for SNF 
QRP Quality Measures and Standardized Patient Assessment Data 
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.

[[Page 17658]]

    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of Transfusions as a standardized 
patient assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Transfusions data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the 
Transfusions data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
Transfusions data element in the National Beta Test can be found in the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Transfusions data element, the TEP supported 
the assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for transfusions, 
stakeholder input, and strong test results, we are proposing that the 
Transfusions data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt 
the Transfusions data element as standardized patient assessment data 
for use in the SNF QRP.
(10) Dialysis (Hemodialysis, Peritoneal Dialysis)
    We are proposing that the Dialysis (Hemodialysis, Peritoneal 
dialysis) data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21070), 
dialysis is a treatment primarily used to provide replacement for lost 
kidney function. Both forms of dialysis (hemodialysis and peritoneal 
dialysis) are resource intensive, not only during the actual dialysis 
process but before, during, and following. Patients and residents who 
need and undergo dialysis procedures are at high risk for physiologic 
and hemodynamic instability from fluid shifts and electrolyte 
disturbances, as well as infections that can lead to sepsis. Further, 
patients or residents receiving hemodialysis are often transported to a 
different facility, or at a minimum, to a different location in the 
same facility for treatment. Close monitoring for fluid shifts, blood 
pressure abnormalities, and other adverse effects is required prior to, 
during, and following each dialysis session. Nursing staff typically 
perform peritoneal dialysis at the bedside, and as with hemodialysis, 
close monitoring is required.
    The proposed data element, Dialysis (Hemodialysis, Peritoneal 
dialysis) consists of the principal Dialysis data element and two 
response option sub-elements: Hemodialysis and Peritoneal dialysis. If 
the assessor indicates that the resident is receiving dialysis on the 
principal Dialysis data element, the assessor would then indicate which 
type (Hemodialysis or Peritoneal dialysis). Dialysis data elements are 
currently included on the MDS in SNFs and the LCDS in LTCHs and assess 
the overall use of dialysis. We are proposing to expand the existing 
Dialysis data element in the MDS to include sub-elements for 
Hemodialysis and Peritoneal dialysis.
    As the result of public feedback described below, in this proposed 
rule, we are proposing a data element that includes the principal 
Dialysis data element and two sub-elements (Hemodialysis and Peritoneal 
dialysis). For more information on the Dialysis data elements, we refer 
readers to the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Dialysis data element was first proposed as standardized 
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 
21070). In that proposed rule, we stated that the proposal was informed 
by input we received on a singular Hemodialysis data element through a 
call for input published on the CMS Measures Management System 
Blueprint website. Input submitted from August 12 to September 12, 2016 
supported the assessment of hemodialysis and recommended that the data 
element be expanded to include peritoneal dialysis. We also stated that 
those commenters had supported the singular Hemodialysis data element, 
noting the relevance of this information for sharing across the care 
continuum to facilitate care coordination and care transitions, the 
potential for this data element to be used to improve quality, and the 
feasibility for use in PAC. In addition, we received comment that the 
item would be useful in improving patient and resident transitions of 
care. We also noted that several commenters had stated that peritoneal 
dialysis should be included in a standardized data element on dialysis 
and recommended collecting information on peritoneal dialysis in 
addition to hemodialysis. The rationale for including peritoneal 
dialysis from commenters included the fact that patients and residents 
receiving peritoneal dialysis will have different needs at post-acute 
discharge compared to those receiving hemodialysis or not having any 
dialysis. Based on these comments, the Hemodialysis data element was 
expanded to include a principal Dialysis data element and two sub-
elements, Hemodialysis and Peritoneal dialysis. We are proposing the 
version of the Dialysis element that

[[Page 17659]]

includes two types of dialysis. A summary report for the August 12 to 
September 12, 2016 public comment period titled ``SPADE August 2016 
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of Dialysis (Hemodialysis, 
Peritoneal dialysis) as a standardized patient assessment data element.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Dialysis data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the Dialysis 
data element to be feasible and reliable for use with PAC patients and 
residents. More information about the performance of the Dialysis data 
element in the National Beta Test can be found in the document titled 
``Proposed Specifications for SNF QRP Quality Measures and Standardized 
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although they did not 
specifically discuss the Dialysis data element, the TEP supported the 
assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for dialysis, 
stakeholder input, and strong test results, we are proposing that the 
Dialysis (Hemodialysis, Peritoneal dialysis) data element with a 
principal data element and two sub-elements meets the definition of 
standardized patient assessment data with respect to special services, 
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act and to adopt the Dialysis (Hemodialysis, Peritoneal dialysis) data 
element as standardized patient assessment data for use in the SNF QRP.
(11) Intravenous (IV) Access (Peripheral IV, Midline, Central line)
    We are proposing that the IV Access (Peripheral IV, Midline, 
Central line) data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21070 
through 21071), patients or residents with central lines, including 
those peripherally inserted or who have subcutaneous central line 
``port'' access, always require vigilant nursing care to keep patency 
of the lines and ensure that such invasive lines remain free from any 
potentially life-threatening events such as infection, air embolism, or 
bleeding from an open lumen. Clinically complex patients and residents 
are likely to be receiving medications or nutrition intravenously. The 
sub-elements included in the IV Access data elements distinguish 
between peripheral access and different types of central access. The 
rationale for distinguishing between a peripheral IV and central IV 
access is that central lines confer higher risks associated with life-
threatening events such as pulmonary embolism, infection, and bleeding.
    The proposed data element, IV Access (Peripheral IV, Midline, 
Central line), consists of the principal IV Access data element and 
three response option sub-elements: Peripheral IV, Midline, and Central 
line. The proposed IV Access data element is not currently included on 
any of the PAC assessment instruments. For more information on the IV 
Access (Peripheral IV, Midline, Central line) data element, we refer 
readers to the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The IV Access data element was first proposed as standardized 
patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 
21070 through 21071). In that proposed rule, we stated that the 
proposal was informed by input we received on one of the PAC PRD data 
elements, Central Line Management, a type of IV access, through a call 
for input published on the CMS Measures Management System Blueprint 
website. Input submitted from August 12 to September 12, 2016 supported 
the assessment of central line management and recommended that the data 
element be broadened to also include other types of IV access. Several 
commenters noted feasibility and importance of facilitating care 
coordination and care transitions. However, a few commenters 
recommended that the definition of this data element be broadened to 
include peripherally inserted central catheters (``PICC lines'') and 
midline IVs. Based on public comment feedback and in consultation with 
expert input, described below, we created an overarching IV Access data 
element with sub-elements for other types of IV access in addition to 
central lines (that is, peripheral IV and midline). This expanded 
version of IV Access is the data element being proposed. A summary 
report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of the IV Access (Peripheral IV, 
Midline,

[[Page 17660]]

Central line, Other) as a standardized patient assessment data element, 
with one commenter encouraging clear guidance in the Resident 
Assessment Instrument User Manual to distinguish between coding 
instructions for this data element and those for other data elements on 
IV treatments.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
IV Access data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the IV Access 
data element to be feasible and reliable for use with PAC patients and 
residents. More information about the performance of the IV Access data 
element in the National Beta Test can be found in the document titled 
``Proposed Specifications for SNF QRP Quality Measures and Standardized 
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the IV Access data element, the TEP supported the 
assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present results of the National Beta 
Test and solicit additional comments. General input on the testing and 
item development process and concerns about burden were received from 
stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for IV access, 
stakeholder input, and strong test results, we are proposing that the 
IV access (Peripheral IV, Midline, Central line) data element with a 
principal data element and three sub-elements meets the definition of 
standardized patient assessment data with respect to special services, 
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act and to adopt the IV Access (Peripheral IV, Midline, Central line) 
data element as standardized patient assessment data for use in the SNF 
QRP.
(12) Nutritional Approach: Parenteral/IV Feeding
    We are proposing that the Parenteral/IV Feeding data element meets 
the definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21071 
through 21072), parenteral nutrition/IV feeding refers to a patient or 
resident being fed intravenously using an infusion pump, bypassing the 
usual process of eating and digestion. The need for IV/parenteral 
feeding indicates a clinical complexity that prevents the patient or 
resident from meeting his or her nutritional needs enterally, and is 
more resource intensive than other forms of nutrition, as it often 
requires monitoring of blood chemistries and the maintenance of a 
central line. Therefore, assessing a patient's or resident's need for 
parenteral feeding is important for care planning and resource use. In 
addition to the risks associated with central and peripheral 
intravenous access, total parenteral nutrition is associated with 
significant risks such as air embolism and sepsis.
    The proposed data element consists of the single Parenteral/IV 
Feeding data element. The proposed Parenteral/IV Feeding data element 
is currently in use in the MDS in SNFs, and equivalent or related data 
elements are in use in the LCDS, IRF-PAI, and OASIS. For more 
information on the Parenteral/IV Feeding data element, we refer readers 
to the document titled ``Proposed Specifications for SNF QRP Quality 
Measures and Standardized Patient Assessment Data Elements,'' available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Parenteral/IV Feeding data element was first proposed as a 
SPADE in the FY 2018 SNF PPS proposed rule (82 FR 21071 through 21072). 
In that proposed rule, we stated that the proposal was informed by 
input we received on Total Parenteral Nutrition (an item with nearly 
the same meaning as the proposed data element, but with the label used 
in the PAC PRD) through a call for input published on the CMS Measures 
Management System Blueprint website. Input submitted from August 12 to 
September 12, 2016 supported this data element, noting its relevance to 
facilitating care coordination and supporting care transitions. After 
the public comment period, the Total Parenteral Nutrition data element 
was renamed Parenteral/IV Feeding, to be consistent with how this data 
element is referred to in the MDS in SNFs. A summary report for the 
August 12 to September 12, 2016 public comment period titled ``SPADE 
August 2016 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of the Parenteral/IV Feeding as a 
standardized patient assessment data element, with one requesting 
``universal'' guidance for coding, which would be clearly defined and 
more broadly applicable to patients and residents in all PAC settings.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Parenteral/IV Feeding data element was included in the National Beta 
Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Parenteral/IV Feeding data element to be feasible and 
reliable for use with PAC patients and residents. More information 
about the performance of the Parenteral/IV Feeding data element in the 
National Beta Test can be found in the document titled ``Proposed 
Specifications for SNF QRP Quality Measures and Standardized Patient 
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/
Quality-

[[Page 17661]]

Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Parenteral/IV Feeding data element, the TEP 
supported the assessment of the special services, treatments, and 
interventions included in the National Beta Test with respect to both 
admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for parenteral/IV 
feeding, stakeholder input, and strong test results, we are proposing 
that the Parenteral/IV Feeding data element meets the definition of 
standardized patient assessment data with respect to special services, 
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act and to adopt the Parenteral/IV Feeding data element as standardized 
patient assessment data for use in the SNF QRP.
(13) Nutritional Approach: Feeding Tube
    We are proposing that the Feeding Tube data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21072), 
the majority of patients admitted to acute care hospitals experience 
deterioration of their nutritional status during their hospital stay, 
making assessment of nutritional status and method of feeding if unable 
to eat orally very important in PAC. A feeding tube can be inserted 
through the nose or the skin on the abdomen to deliver liquid nutrition 
into the stomach or small intestine. Feeding tubes are resource 
intensive and, therefore, are important to assess for care planning and 
resource use. Patients with severe malnutrition are at higher risk for 
a variety of complications.\92\ In PAC settings, there are a variety of 
reasons that patients and residents may not be able to eat orally 
(including clinical or cognitive status).
---------------------------------------------------------------------------

    \92\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The 
link between nutritional status and clinical outcome: can 
nutritional intervention modify it?'' Am J of Clinical Nutrition, 
47(2): 352-356.
---------------------------------------------------------------------------

    The proposed data element consists of the single Feeding Tube data 
element. The Feeding Tube data element is currently included in the MDS 
for SNFs, and in the OASIS for HHAs, where it is labeled Enteral 
Nutrition. A related data element, collected in the IRF-PAI for IRFs 
(``Tube/Parenteral Feeding''), assesses use of both feeding tubes and 
parenteral nutrition. For more information on the Feeding Tube data 
element, we refer readers to the document titled ``Proposed 
Specifications for SNF QRP Quality Measures and Standardized Patient 
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Feeding Tube data element was first proposed as a SPADE in the 
FY 2018 SNF PPS proposed rule (82 FR 21072). In that proposed rule, we 
stated that the proposal was informed by input we received through a 
call for input published on the CMS Measures Management System 
Blueprint website. Input submitted from August 12 to September 12, 2016 
on an Enteral Nutrition data element (the Enteral Nutrition data item 
is the same as the data element we are proposing in this proposed rule, 
but is used in the OASIS under a different name) supported the data 
element, noting the importance of assessing enteral nutrition status 
for facilitating care coordination and care transitions. After the 
public comment period, the Enteral Nutrition data element used in 
public comment was renamed Feeding Tube, indicating the presence of an 
assistive device. A summary report for the August 12 to September 12, 
2016 public comment period titled ``SPADE August 2016 Public Comment 
Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of the Feeding Tube as a 
standardized patient assessment data element. Another commenter 
recommended that the term ``enteral feeding'' be used instead of 
``feeding tube.''
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Feeding Tube data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the Feeding 
Tube data element to be feasible and reliable for use with PAC patients 
and residents. More information about the performance of the Feeding 
Tube data element in the National Beta Test can be found in the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Feeding Tube data element, the TEP supported 
the assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-

[[Page 17662]]

Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-
of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for feeding tubes, 
stakeholder input, and strong test results, we are proposing that the 
Feeding Tube data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt 
the Feeding Tube data element as standardized patient assessment data 
for use in the SNF QRP.
(14) Nutritional Approach: Mechanically Altered Diet
    We are proposing that the Mechanically Altered Diet data element 
meets the definition of standardized patient assessment data with 
respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21072 
through 21073), the Mechanically Altered Diet data element refers to 
food that has been altered to make it easier for the patient or 
resident to chew and swallow, and this type of diet is used for 
patients and residents who have difficulty performing these functions. 
Patients with severe malnutrition are at higher risk for a variety of 
complications.\93\
---------------------------------------------------------------------------

    \93\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The 
link between nutritional status and clinical outcome: can 
nutritional intervention modify it?'' Am J of Clinical Nutrition, 
47(2): 352-356.
---------------------------------------------------------------------------

    In PAC settings, there are a variety of reasons that patients and 
residents may have impairments related to oral feedings, including 
clinical or cognitive status. The provision of a mechanically altered 
diet may be resource intensive, and can signal difficulties associated 
with swallowing/eating safety, including dysphagia. In other cases, it 
signifies the type of altered food source, such as ground or puree that 
will enable the safe and thorough ingestion of nutritional substances 
and ensure safe and adequate delivery of nourishment to the patient. 
Often, patients and residents on mechanically altered diets also 
require additional nursing supports, such as individual feeding or 
direct observation, to ensure the safe consumption of the food product. 
Assessing whether a patient or resident requires a mechanically altered 
diet is therefore important for care planning and resource 
identification.
    The proposed data element consists of the single Mechanically 
Altered Diet data element. The proposed data element is currently 
included on the MDS for SNFs. A related data element (``Modified food 
consistency/supervision'') is currently included on the IRF-PAI for 
IRFs. Another related data element is included in the OASIS for HHAs 
that collects information about independent eating that requires ``a 
liquid, pureed or ground meat diet.'' For more information on the 
Mechanically Altered Diet data element, we refer readers to the 
document titled ``Proposed Specifications for SNF QRP Quality Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Mechanically Altered Diet data element was first proposed as 
standardized patient assessment data in the FY 2018 SNF PPS proposed 
rule (82 FR 21072 through 21073).
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported the adoption of the Mechanically Altered Diet 
as a standardized patient assessment data element, with one requesting 
``universal'' guidance for coding, which would be clearly defined and 
more broadly applicable to patients and residents in all PAC settings.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Mechanically Altered Diet data element was included in the National 
Beta Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Mechanically Altered Diet data element to be feasible and 
reliable for use with PAC patients and residents. More information 
about the performance of the Mechanically Altered Diet data element in 
the National Beta Test can be found in the document titled ``Proposed 
Specifications for SNF QRP Quality Measures and Standardized Patient 
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Mechanically Altered Diet data element, the 
TEP supported the assessment of the special services, treatments, and 
interventions included in the National Beta Test with respect to both 
admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.

[[Page 17663]]

    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for mechanically 
altered diet, stakeholder input, and strong test results, we are 
proposing that the Mechanically Altered Diet data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act and to adopt the Mechanically Altered 
Diet data element as standardized patient assessment data for use in 
the SNF QRP.
(15) Nutritional Approach: Therapeutic Diet
    We are proposing that the Therapeutic Diet data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21073), a 
therapeutic diet refers to meals planned to increase, decrease, or 
eliminate specific foods or nutrients in a patient's or resident's 
diet, such as a low-salt diet, for the purpose of treating a medical 
condition. The use of therapeutic diets among patients and residents in 
PAC provides insight on the clinical complexity of these patients and 
residents and their multiple comorbidities. Therapeutic diets are less 
resource intensive from the bedside nursing perspective, but do signify 
one or more underlying clinical conditions that preclude the patient 
from eating a regular diet. The communication among PAC providers about 
whether a patient is receiving a particular therapeutic diet is 
critical to ensure safe transitions of care.
    The proposed data element consists of the single Therapeutic Diet 
data element. This data element is currently in use in the MDS in SNFs. 
For more information on the Therapeutic Diet data element, we refer 
readers to the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Therapeutic Diet data element was first proposed as 
standardized patient assessment data in the FY 2018 SNF PPS proposed 
rule (82 FR 21073). In response to our proposal in the FY 2018 SNF PPS 
proposed rule, commenters supported the adoption of the Therapeutic 
Diet as a standardized patient assessment data element. Two commenters 
stated that the coding instructions should be clear and more broadly 
applicable to patients and residents in all PAC settings. Another two 
commenters suggested that the definition of Therapeutic Diet should be 
aligned with the Academy of Nutrition and Dietetics' definition, with 
one stating that ``medically altered diet'' should be added to the 
nutritional data elements.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Therapeutic Diet data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the 
Therapeutic Diet data element to be feasible and reliable for use with 
PAC patients and residents. More information about the performance of 
the Therapeutic Diet data element in the National Beta Test can be 
found in the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. Although the TEP did not 
specifically discuss the Therapeutic Diet data element, the TEP 
supported the assessment of the special services, treatments, and 
interventions included in the National Beta Test with respect to both 
admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on Standardized Patient Assessment 
Data Elements (SPADEs) Received After November 27, 2018 Stakeholder 
Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for therapeutic diet, 
stakeholder input, and strong test results, we are proposing that the 
Therapeutic Diet data element meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to 
adopt the Therapeutic data element as standardized patient assessment 
data for use in the SNF QRP.
(16) High Risk Drug Classes: Use and Indication
    We are proposing that the High-Risk Drug Classes: Use and 
Indication data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    Most patients and residents receiving PAC services depend on short- 
and long-term medications to manage their medical conditions. However, 
as a treatment, medications are not without risk; medications are in 
fact a leading cause of adverse events. A study by the

[[Page 17664]]

U.S. Department of Health and Human Services found that 31 percent of 
adverse events that occurred in 2008 among hospitalized Medicare 
beneficiaries were related to medication.\94\ Moreover, changes in a 
patient's condition, medications, and transitions between care settings 
put patients and residents at risk of medication errors and adverse 
drug events (ADEs). ADEs may be caused by medication errors such as 
drug omissions, errors in dosage, and errors in dosing frequency.\95\
---------------------------------------------------------------------------

    \94\ U.S. Department of Health and Human Services. Office of 
Inspector General. Daniel R. Levinson. Adverse Events in Hospitals: 
National Incidence Among Medicare Beneficiaries. OEI-06-09-00090. 
November 2010.
    \95\ Boockvar K.S., Liu S., Goldstein N., Nebeker J., Siu A., 
Fried T. Prescribing discrepancies likely to cause adverse drug 
events after patient transfer. Qual Saf Health Care. 2009;18(1):32-
6.
---------------------------------------------------------------------------

    ADEs are known to occur across different types of healthcare 
settings. For example, the incidence of ADEs in the outpatient setting 
has been estimated at 1.15 ADEs per 100 person-months,\96\ while the 
rate of ADEs in the long-term care setting is approximately 9.80 ADEs 
per 100 resident-months.\97\ In the hospital setting, the incidence has 
been estimated at 15 ADEs per 100 admissions.\98\ In addition, 
approximately half of all hospital-related medication errors and 20 
percent of ADEs occur during transitions within, admission to, transfer 
to, or discharge from a hospital.99 100 101 ADEs are more 
common among older adults, who make up most patients receiving PAC 
services. The rate of emergency department visits for ADEs is three 
times higher among adults 65 years of age and older compared to that 
among those younger than age 65.\102\
---------------------------------------------------------------------------

    \96\ Gandhi T.K., Seger A.C., Overhage J.M., et al. Outpatient 
adverse drug events identified by screening electronic health 
records. J Patient Saf 2010;6:91-6.doi:10.1097/PTS.0b013e3181dcae06.
    \97\ Gurwitz J.H., Field T.S., Judge J., Rochon P., Harrold 
L.R., Cadoret C., et al. The incidence of adverse drug events in two 
large academic long-term care facilities. Am J Med. 2005; 
118(3):2518. Epub 2005/03/05. https://doi.org/10.1016/j.amjmed.2004.09.018 PMID: 15745723.
    \98\ Hug B.L., Witkowski D.J., Sox C.M., Keohane C.A., Seger 
D.L., Yoon C., Matheny M.E., Bates D.W.. Occurrence of adverse, 
often preventable, events in community hospitals involving 
nephrotoxic drugs or those excreted by the kidney. Kidney Int. 2009; 
76:1192-1198. [PubMed: 19759525].
    \99\ Barnsteiner J.H. Medication reconciliation: transfer of 
medication information across settings-keeping it free from error. J 
Infus Nurs. 2005;28(2 Suppl):31-36.
    \100\ Rozich J., Roger, R. Medication safety: one organization's 
approach to the challenge. Journal of Clinical Outcomes Management. 
2001(8):27-34.
    \101\ Gleason K.M., Groszek J.M., Sullivan C., Rooney D., 
Barnard C., Noskin G.A. Reconciliation of discrepancies in 
medication histories and admission orders of newly hospitalized 
patients. Am J Health Syst Pharm. 2004;61(16):1689-1695.
    \102\ Shehab N., Lovegrove M.C., Geller A.I., Rose K.O., Weidle 
N.J., Budnitz D.S. US emergency department visits for outpatient 
adverse drug events, 2013-2014. JAMA. doi: 10.1001/jama.2016.16201.
---------------------------------------------------------------------------

    Understanding the types of medication a patient is taking and the 
reason for its use are key facets of a patient's treatment with respect 
to medication. Some classes of drugs are associated with more risk than 
others.\103\ We are proposing one High-Risk Drug Class data element 
with six sub-elements. The six medication classes response options are: 
anticoagulants; antiplatelets; hypoglycemics (including insulin); 
opioids; antipsychotics; and antibiotics. These drug classes are high-
risk due to the adverse effects that may result from use. In 
particular: bleeding risk is associated with anticoagulants and 
antiplatelets; 104 105 fluid retention, heart failure, and 
lactic acidosis are associated with hypoglycemics; \106\ misuse is 
associated with opioids; \107\ fractures and strokes are associated 
with antipsychotics; 108 109 and various adverse events, 
such as central nervous systems effects and gastrointestinal 
intolerance, are associated with antimicrobials,\110\ the larger 
category of medications that include antibiotics. Moreover, some 
medications in five of the six drug classes included in this data 
element are included in the 2019 Updated Beers Criteria[supreg] list as 
potentially inappropriate medications for use in older adults.\111\ 
Finally, although a complete medication list should record several 
important attributes of each medication (for example, dosage, route, 
stop date), recording an indication for the drug is of crucial 
importance.\112\
---------------------------------------------------------------------------

    \103\ Ibid.
    \104\ Shoeb M., Fang M.C. Assessing bleeding risk in patients 
taking anticoagulants. J Thromb Thrombolysis. 2013;35(3):312-319. 
doi: 10.1007/s11239-013-0899-7.
    \105\ Melkonian M., Jarzebowski W., Pautas E. Bleeding risk of 
antiplatelet drugs compared with oral anticoagulants in older 
patients with atrial fibrillation: a systematic review and 
meta[hyphen]analysis. J Thromb Haemost. 2017;15:1500-1510. DOI: 
10.1111/jth.13697.
    \106\ Hamnvik O.P., McMahon G.T. Balancing Risk and Benefit with 
Oral Hypoglycemic Drugs. The Mount Sinai journal of medicine, New 
York. 2009; 76:234-243.
    \107\ Naples J.G., Gellad W.F., Hanlon J.T. The Role of Opioid 
Analgesics in Geriatric Pain Management. Clin Geriatr Med. 2016;32 
(4):725-735.
    \108\ Rigler S.K., Shireman T.I., Cook-Wiens G.J., Ellerbeck 
E.F., Whittle J.C., Mehr D.R., Mahnken J.D. Fracture risk in nursing 
home residents initiating antipsychotic medications. J Am Geriatr 
Soc. 2013; 61(5):715-722. [PubMed: 23590366].
    \109\ Wang S., Linkletter C., Dore D. et al. Age, 
antipsychotics, and the risk of ischemic stroke in the Veterans 
Health Administration. Stroke 2012;43:28-31. doi:10.1161/
STROKEAHA.111.617191.
    \110\ Faulkner C.M., Cox H.L., Williamson J.C. Unique aspects of 
antimicrobial use in older adults. Clin Infect Dis. 2005;40(7):997-
1004.
    \111\ American Geriatrics Society 2019 Beers Criteria Update 
Expert Panel. American Geriatrics Society 2019 Updated Beers 
Criteria for Potentially Inappropriate Medication Use in Older 
Adults. J Am Geriatr Soc 2019; 00:1-21. DOI: 10.1111/jgs.15767.
    \112\ Li Y., Salmasian H., Harpaz R., Chase H., Friedman C. 
Determining the reasons for medication prescriptions in the EHR 
using knowledge and natural language processing. AMIA Annu Symp 
Proc. 2011;2011: 768-76.
---------------------------------------------------------------------------

    The High-Risk Drug Classes: Use and Indication data element 
requires an assessor to record whether or not a resident is taking any 
medications within the six drug classes. The six response options for 
this data element are high-risk drug classes with particular relevance 
to PAC patients and residents, as identified by our data element 
contractor. The six response options are Anticoagulants, Antiplatelets, 
Hypoglycemics, Opioids, Antipsychotics, and Antibiotics. For each drug 
class, the assessor is asked to indicate if the resident is taking any 
medications within the class, and, for drug classes in which 
medications were being taken, whether indications for all drugs in the 
class are noted in the medical record. For example, for the response 
option Anticoagulants, if the assessor indicates that the resident is 
taking anticoagulant medication, the assessor would then indicate if an 
indication is recorded in the medication record for the 
anticoagulant(s).
    The High-Risk Drug Classes: Use and Indication data element that is 
being proposed as a SPADE was developed as part of a larger set of data 
elements to assess medication reconciliation, the process of obtaining 
a patient's multiple medication lists and reconciling any 
discrepancies. Similar data elements on some high-risk medications are 
already included in the MDS. We are proposing to modify and expand 
existing data elements in the MDS to include additional high-risk drug 
classes and indications for all drug classes. For more information on 
the High-Risk Drug Classes: Use and Indication data element, we refer 
readers to the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.

[[Page 17665]]

    We sought public input on the relevance of conducting assessments 
on medication reconciliation and specifically on the proposed High-Risk 
Drug Classes: Use and Indication data element. Our data element 
contractor presented data elements related to medication reconciliation 
to the TEP convened on April 6 and 7, 2016. The TEP supported a focus 
on high-risk drugs, because of higher potential for harm to patients 
and residents, and were in favor of a data element to capture whether 
or not indications for medications were recorded in the medical record. 
A summary of the April 6 and 7, 2016 TEP meeting titled ``SPADE 
Technical Expert Panel Summary (First Convening)'' is available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. Medication reconciliation data 
elements were also discussed at a second TEP meeting on January 5 and 
6, 2017, convened by our data element contractor. At this meeting, the 
TEP agreed about the importance of evaluating the medication 
reconciliation process, but disagreed about how this could be 
accomplished through standardized assessment. The TEP also disagreed 
about the usability and appropriateness of using the Beers Criteria to 
identify high-risk medications.\113\ A summary of the January 5 and 6, 
2017 TEP meeting titled ``SPADE Technical Expert Panel Summary (Second 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \113\ American Geriatrics Society 2015 Beers Criteria Update 
Expert Panel. American Geriatrics Society. Updated Beers Criteria 
for Potentially Inappropriate Medication Use in Older Adults. J Am 
Geriatr Soc 2015; 63:2227-2246.
---------------------------------------------------------------------------

    We also solicited public input on data elements related to 
medication reconciliation during a public input period from April 26 to 
June 26, 2017. Several commenters expressed support for the medication 
reconciliation data elements that were put on display, noting the 
importance of medication reconciliation in preventing medication errors 
and stated that the items seemed feasible and clinically useful. A few 
commenters were critical of the choice of 10 drug classes posted during 
that comment period, arguing that ADEs are not limited to high-risk 
drugs, and raised issues related to training assessors to correctly 
complete a valid assessment of medication reconciliation. A summary 
report for the April 26 to June 26, 2017 public comment period titled 
``SPADE May-June 2017 Public Comment Summary Report'' is available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The High-Risk Drug Classes: Use and Indication data element was 
included in the National Beta Test of candidate data elements conducted 
by our data element contractor from November 2017 to August 2018. 
Results of this test found the High-Risk Drug Classes: Use and 
Indication data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
High-Risk Drug Classes: Use and Indication data element in the National 
Beta Test can be found in the document titled ``Proposed Specifications 
for SNF QRP Quality Measures and Standardized Patient Assessment Data 
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. The TEP acknowledged the 
challenges of assessing medication safety, but were supportive of some 
of the data elements focused on medication reconciliation that were 
tested in the National Beta Test. The TEP was especially supportive of 
the focus on the six high-risk drug classes and using these classes to 
assess whether the indication for a drug is recorded. A summary of the 
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel 
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. These 
activities provided updates on the field-testing work and solicited 
feedback on data elements considered for standardization, including the 
High-Risk Drug Classes: Use and Indication data element. One 
stakeholder group was critical of the six drug classes included as 
response options in the High-Risk Drug Classes: Use and Indication data 
element, noting that potentially risky medications (for example, muscle 
relaxants) are not included in this list; that there may be important 
differences between drugs within classes (for example, more recent 
versus older style antidepressants); and that drug allergy information 
is not captured. Finally, on November 27, 2018, our data element 
contractor hosted a public meeting of stakeholders to present the 
results of the National Beta Test and solicit additional comments. 
General input on the testing and item development process and concerns 
about burden were received from stakeholders during this meeting and 
via email through February 1, 2019. Additionally, one commenter 
questioned whether the time to complete this SPADE would differ across 
settings. A summary of the public input received from the November 27, 
2018 stakeholder meeting titled ``Input on Standardized Patient 
Assessment Data Elements (SPADEs) Received After November 27, 2018 
Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing high-risk drugs and for 
whether or not indications are noted for high-risk drugs, stakeholder 
input, and strong test results, we are proposing that the High-Risk 
Drug Classes: Use and Indication data element meets the definition of 
standardized patient assessment data with respect to special services, 
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act and to adopt the High-Risk Drug Classes: Use and Indication data 
element as standardized patient assessment data for use in the SNF QRP.
d. Medical Condition and Comorbidity Data
    Assessing medical conditions and comorbidities is critically 
important for care planning and safety for patients and residents 
receiving PAC services, and the standardized assessment of selected 
medical conditions and comorbidities across PAC providers is important 
for managing care transitions and understanding medical complexity.
    Below we discuss our proposals for data elements related to the 
medical

[[Page 17666]]

condition of pain as standardized patient assessment data. Appropriate 
pain management begins with a standardized assessment, and thereafter 
establishing and implementing an overall plan of care that is person-
centered, multi-modal, and includes the treatment team and the patient. 
Assessing and documenting the effect of pain on sleep, participation in 
therapy, and other activities may provide information on undiagnosed 
conditions and comorbidities and the level of care required, and do so 
more objectively than subjective numerical scores. With that, we assess 
that taken separately and together, these proposed data elements are 
essential for care planning, consistency across transitions of care, 
and identifying medical complexities including undiagnosed conditions. 
We also conclude that it is the standard of care to always consider the 
risks and benefits associated with a personalized care plan, including 
the risks of any pharmacological therapy, especially opioids.\114\ We 
also conclude that in addition to assessing and appropriately treating 
pain through the optimum mix of pharmacologic, non-pharmacologic, and 
alternative therapies, while being cognizant of current prescribing 
guidelines, clinicians in partnership with patients are best able to 
mitigate factors that contribute to the current opioid crisis.\115\ 
\116\ \117\
---------------------------------------------------------------------------

    \114\ Department of Health and Human Services: Pain Management 
Best Practices Inter-Agency Task Force. Draft Report on Pain 
Management Best Practices: Updates, Gaps, Inconsistencies, and 
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \115\ . Department of Health and Human Services: Pain Management 
Best Practices Inter-Agency Task Force. Draft Report on Pain 
Management Best Practices: Updates, Gaps, Inconsistencies, and 
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \116\ Fishman S.M., Carr D.B., Hogans B., et al. Scope and 
Nature of Pain- and Analgesia-Related Content of the United States 
Medical Licensing Examination (USMLE). Pain Med Malden Mass. 
2018;19(3):449-459. doi:10.1093/pm/pnx336.
    \117\ Fishman S.M., Young H.M., Lucas Arwood E., et al. Core 
competencies for pain management: results of an interprofessional 
consensus summit. Pain Med Malden Mass. 2013;14(7):971-981. 
doi:10.1111/pme.12107.
---------------------------------------------------------------------------

    In alignment with our Meaningful Measures Initiative, accurate 
assessment of medical conditions and comorbidities of patients and 
residents in PAC is expected to make care safer by reducing harm caused 
in the delivery of care; promote effective prevention and treatment of 
chronic disease; strengthen person and family engagement as partners in 
their care; and promote effective communication and coordination of 
care. The SPADEs will enable or support: Clinical decision-making and 
early clinical intervention; person-centered, high quality care 
through: facilitating better care continuity and coordination; better 
data exchange and interoperability between settings; and longitudinal 
outcome analysis. Therefore, reliable data elements assessing medical 
conditions and comorbidities are needed in order to initiate a 
management program that can optimize a patient's or resident's 
prognosis and reduce the possibility of adverse events.
    We are inviting comment that apply specifically to the standardized 
patient assessment data for the category of medical conditions and co-
morbidities, specifically on:
(1) Pain Interference (Pain Effect on Sleep, Pain Interference With 
Therapy Activities, and Pain Interference With Day-to-Day Activities)
    In acknowledgement of the opioid crisis, we specifically are 
seeking comment on whether or not we should add these pain items in 
light of those concerns. Commenters should address to what extent 
collection of the data below through patient queries might encourage 
providers to prescribe opioids.
    We are proposing that a set of three data elements on the topic of 
Pain Interference (Pain Effect on Sleep, Pain Interference with Therapy 
Activities, and Pain Interference with Day-to-Day Activities) meet the 
definition of standardized patient assessment data with respect to 
medical condition and comorbidity data under section 1899B(b)(1)(B)(iv) 
of the Act.
    The practice of pain management began to undergo significant 
changes in the 1990s because the inadequate, non-standardized, non-
evidence-based assessment and treatment of pain became a public health 
issue.\118\ In pain management, a critical part of providing 
comprehensive care is performance of a thorough initial evaluation, 
including assessment of both the medical and any biopsychosocial 
factors causing or contributing to the pain, with a treatment plan to 
address the causes of pain and to manage pain that persists over 
time.\119\ Quality pain management, based on current guidelines and 
evidence-based practices, can minimize unnecessary opioid prescribing 
both by offering alternatives or supplemental treatment to opioids and 
by clearly stating when they may be appropriate, and how to utilize 
risk-benefit analysis for opioid and non-opioid treatment 
modalities.\120\ Pain is not a surprising symptom in PAC patients and 
residents, where healing, recovery, and rehabilitation often require 
regaining mobility and other functions after an acute event. 
Standardized assessment of pain that interferes with function is an 
important first step towards appropriate pain management in PAC 
settings. The National Pain Strategy called for refined assessment 
items on the topic of pain, and describes the need for these improved 
measures to be implemented in PAC assessments.\121\ Further, the focus 
on pain interference, as opposed to pain intensity or pain frequency, 
was supported by the TEP convened by our data element contractor as an 
appropriate and actionable metric for assessing pain. A summary of the 
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel 
Summary (Third Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \118\ Institute of Medicine. Relieving Pain in America: A 
Blueprint for Transforming Prevention, Care, Education, and 
Research. Washington (DC): National Academies Press (US); 2011. 
http://www.ncbi.nlm.nih.gov/books/NBK91497/.
    \119\ Department of Health and Human Services: Pain Management 
Best Practices Inter-Agency Task Force. Draft Report on Pain 
Management Best Practices: Updates, Gaps, Inconsistencies, and 
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \120\ National Academies. Pain Management and the Opioid 
Epidemic: Balancing Societal and Individual Benefits and Risks of 
Prescription Opioid Use. Washington DC: National Academies of 
Sciences, Engineering, and Medicine.; 2017.
    \121\ National Pain Strategy: A Comprehensive Population-Health 
Level Strategy for Pain. https://iprcc.nih.gov/sites/default/files/HHSNational_Pain_Strategy_508C.pdf.
---------------------------------------------------------------------------

    We appreciate the important concerns related to the misuse and 
overuse of opioids in the treatment of pain and to that end we note 
that in this proposed rule we have also proposed a SPADE that assess 
for the use of, as well as importantly the indication for that use of, 
high risk drugs, including opioids. Further, in the FY 2017 SNF PPS 
final rule (81 FR 52039) we adopted the Drug Regimen Review Conducted 
With Follow-Up for Identified Issues--Post Acute Care (PAC) SNF QRP 
measure which assesses whether PAC providers were responsive to 
potential or actual clinically significant medication issue(s), which 
includes issues associated with use and misuse of opioids for pain 
management, when such issues were identified.

[[Page 17667]]

    We also note that the proposed SPADE related to pain assessment are 
not associated with any particular approach to management. Since the 
use of opioids is associated with serious complications, particularly 
in the elderly,122 123 124 an array of successful non-
pharmacologic and non-opioid approaches to pain management may be 
considered PAC providers have historically used a range of pain 
management strategies, including non-steroidal anti-inflammatory drugs, 
ice, transcutaneous electrical nerve stimulation (TENS) therapy, 
supportive devices, acupuncture, and the like. In addition, non-
pharmacological interventions for pain management include, but are not 
limited to, biofeedback, application of heat/cold, massage, physical 
therapy, nerve block, stretching and strengthening exercises, 
chiropractic, electrical stimulation, radiotherapy, and 
ultrasound.125 126 127
---------------------------------------------------------------------------

    \122\ Chau, D.L., Walker, V., Pai, L., & Cho, L.M. (2008). 
Opiates and elderly: use and side effects. Clinical interventions in 
aging, 3(2), 273-8.
    \123\ Fine, P.G. (2009). Chronic Pain Management in Older 
Adults: Special Considerations. Journal of Pain and Symptom 
Management, 38(2): S4-S14.
    \124\ Solomon, D.H., Rassen, J.A., Glynn, R.J., Garneau, K., 
Levin, R., Lee, J., & Schneeweiss, S.. (2010). Archives Internal 
Medicine, 170(22):1979-1986.
    \125\ Byrd L. Managing chronic pain in older adults: a long-term 
care perspective. Annals of Long-Term Care: Clinical Care and Aging. 
2013;21(12):34-40.
    \126\ Kligler, B., Bair, M.J., Banerjea, R. et al. (2018). 
Clinical Policy Recommendations from the VHA State-of-the-Art 
Conference on Non-Pharmacological Approaches to Chronic 
Musculoskeletal Pain. Journal of General Internal Medicine, 33(Suppl 
1): 16. https://doi.org/10.1007/s11606-018-4323-z.
    \127\ Chou, R., Deyo, R., Friedly, J., et al. (2017). 
Nonpharmacologic Therapies for Low Back Pain: A Systematic Review 
for an American College of Physicians Clinical Practice Guideline. 
Annals of Internal Medicine, 166(7):493-505.
---------------------------------------------------------------------------

    We believe that standardized assessment of pain interference will 
support PAC clinicians in applying best-practices in pain management 
for chronic and acute pain, consistent with current clinical 
guidelines. For example, the standardized assessment of both opioids 
and pain interference would support providers in successfully tapering 
patients/residents who arrive in the PAC setting with long-term opioid 
use off of opioids onto non-pharmacologic treatments and non-opioid 
medications, as recommended by the Society for Post-Acute and Long-Term 
Care Medicine,\128\ and consistent with HHS's 5-Point Strategy To 
Combat the Opioid Crisis \129\ which includes ``Better Pain 
Management.''
---------------------------------------------------------------------------

    \128\ Society for Post-Acute and Long-Term Care Medicine (AMDA). 
(2018). Opioids in Nursing Homes: Position Statement. https://paltc.org/opioids%20in%20nursing%20homes.
    \129\ https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/index.html.
---------------------------------------------------------------------------

    The Pain Interference data elements consist of three data elements: 
Pain Effect on Sleep, Pain Interference with Therapy Activities, and 
Pain Interference with Day-to-Day Activities. Pain Effect on Sleep 
assesses the frequency with which pain effects a resident's sleep. Pain 
Interference with Therapy Activities assesses the frequency with which 
pain interferes with a resident's ability to participate in therapies. 
The Pain Interference with Day-to-Day Activities assesses the extent to 
which pain interferes with a resident's ability to participate in day-
to-day activities excluding therapy.
    A similar data element on the effect of pain on activities is 
currently included in the OASIS. A similar data element on the effect 
on sleep is currently included in the MDS instrument. We are proposing 
to expand and modify the existing Pain data elements in the MDS to 
include the Pain Effect on Sleep; Pain Interference with Therapy 
Activities; and Pain Interference with Day to Day Activities data 
elements. For more information on the Pain Interference data elements, 
we refer readers to the document titled ``Proposed Specifications for 
SNF QRP Quality Measures and Standardized Patient Assessment Data 
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We sought public input on the relevance of conducting assessments 
on pain and specifically on the larger set of Pain Interview data 
elements included in the National Beta Test. The proposed data elements 
were supported by comments from the TEP meeting held by our data 
element contractor on April 7 to 8, 2016. The TEP affirmed the 
feasibility and clinical utility of pain as a concept in a standardized 
assessment. The TEP agreed that data elements on pain interference with 
ability to participate in therapies versus other activities should be 
addressed. Further, during a more recent convening of the same TEP on 
September 17, 2018, the TEP supported the interview-based pain data 
elements included in the National Beta Test. The TEP members were 
particularly supportive of the items that focused on how pain 
interferes with activities (that is, Pain Interference data elements), 
because understanding the extent to which pain interferes with function 
would enable clinicians to determine the need for appropriate pain 
treatment. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We held a public input period in 2016 to solicit feedback on the 
standardization of pain and several other items that were under 
development in prior efforts. From the prior public comment period, we 
included several pain data elements (Pain Effect on Sleep; Pain 
Interference--Therapy Activities; Pain Interference--Other Activities) 
in a second call for public input, open from April 26 to June 26, 2017. 
The items we sought comment on were modified from all stakeholder and 
test efforts. Commenters provided general comments about pain 
assessment in general in addition to feedback on the specific pain 
items. A few commenters shared their support for assessing pain, the 
potential for pain assessment to improve the quality of care, and for 
the validity and reliability of the data elements. Commenters affirmed 
that the item of pain and the effect on sleep would be suitable for PAC 
settings. Commenters' main concerns included redundancy with existing 
data elements, feasibility and utility for cross-setting use, and the 
applicability of interview-based items to patients and residents with 
cognitive or communication impairments, and deficits. A summary report 
for the April 26 to June 26, 2017 public comment period titled ``SPADE 
May-June 2017 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Pain Interference data elements were included in the National 
Beta Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Pain Interference data elements to be feasible and reliable 
for use with PAC patients and residents. More information about the 
performance of the Pain Interference data elements in the National Beta 
Test can be found in the document titled ``Proposed Specifications for 
SNF QRP Quality Measures and Standardized Patient Assessment Data 
Elements,''

[[Page 17668]]

available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the 
standardized patient assessment data elements. The TEP supported the 
interview-based pain data elements included in the National Beta Test. 
The TEP members were particularly supportive of the items that focused 
on how pain interferes with activities (that is, Pain Interference data 
elements), because understanding the extent to which pain interferes 
with function would enable clinicians to determine the need for pain 
treatment. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. Additionally, one commenter expressed strong support for the Pain 
data elements and was encouraged by the fact that this portion of the 
assessment goes beyond merely measuring the presence of pain. A summary 
of the public input received from the November 27, 2018 stakeholder 
meeting titled ``Input on Standardized Patient Assessment Data Elements 
(SPADEs) Received After November 27, 2018 Stakeholder Meeting'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for the effect of pain 
on function, stakeholder input, and strong test results, we are 
proposing that the three Pain Interference data elements (Pain Effect 
on Sleep, Pain Interference with Therapy Activities, and Pain 
Interference with Day-to-Day Activities) meet the definition of 
standardized patient assessment data with respect to medical conditions 
and comorbidities under section 1899B(b)(1)(B)(iv) of the Act and to 
adopt the Pain Interference data elements (Pain Effect on Sleep, Pain 
Interference with Therapy Activities, and Pain Interference with Day-
to-Day Activities) data elements as standardized patient assessment 
data for use in the SNF QRP.
e. Impairment Data
    Hearing and vision impairments are conditions that, if unaddressed, 
affect activities of daily living, communication, physical functioning, 
rehabilitation outcomes, and overall quality of life. Sensory 
limitations can lead to confusion in new settings, increase isolation, 
contribute to mood disorders, and impede accurate assessment of other 
medical conditions. Failure to appropriately assess, accommodate, and 
treat these conditions increases the likelihood that patients and 
residents will require more intensive and prolonged treatment. Onset of 
these conditions can be gradual, so individualized assessment with 
accurate screening tools and follow-up evaluations are essential to 
determining which patients and residents need hearing- or vision-
specific medical attention or assistive devices and accommodations, 
including auxiliary aids and/or services, and to ensure that person-
directed care plans are developed to accommodate a patient's or 
resident's needs. Accurate diagnosis and management of hearing or 
vision impairment would likely improve rehabilitation outcomes and care 
transitions, including transition from institutional-based care to the 
community. Accurate assessment of hearing and vision impairment would 
be expected to lead to appropriate treatment, accommodations, including 
the provision of auxiliary aids and services during the stay, and 
ensure that patients and residents continue to have their vision and 
hearing needs met when they leave the facility.
    In alignment with our Meaningful Measures Initiative, we expect 
accurate and individualized assessment, treatment, and accommodation of 
hearing and vision impairments of patients and residents in PAC to make 
care safer by reducing harm caused in the delivery of care; promote 
effective prevention and treatment of chronic disease; strengthen 
person and family engagement as partners in their care; and promote 
effective communication and coordination of care. For example, 
standardized assessment of hearing and vision impairments used in PAC 
will support ensuring patient safety (for example, risk of falls), 
identifying accommodations needed during the stay, and appropriate 
support needs at the time of discharge or transfer. Standardized 
assessment of these data elements will: Enable or support clinical 
decision-making and early clinical intervention; person-centered, high 
quality care (for example, facilitating better care continuity and 
coordination); better data exchange and interoperability between 
settings; and longitudinal outcome analysis. Therefore, reliable data 
elements assessing hearing and vision impairments are needed to 
initiate a management program that can optimize a patient's or 
resident's prognosis and reduce the possibility of adverse events.
    Comments on the category of impairments were also submitted by 
stakeholders during the FY 2018 SNF PPS proposed rule (82 FR 21074 
through 21076) public comment period. A commenter stated hearing, 
vision, and communication assessments should be administered at the 
beginning of assessment process, to provide evidence about any sensory 
deficits that may affect the patient's or resident's ability to 
participate in the assessment and to allow the assessor to offer an 
assistive device. Another commenter supported the decision to assess 
hearing and vision with respect to admission only and not discharge, 
and to use existing MDS items for hearing and vision, thereby not 
creating additional burden.
    We are inviting comment on our proposals to collect as standardized 
patient assessment data the following data with respect to impairments.
(1) Hearing
    We are proposing that the Hearing data element meets the definition 
of standardized patient assessment data with respect to impairments 
under section 1899B(b)(1)(B)(v) of the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21074 
through 21075), accurate assessment of hearing impairment is important 
in the PAC setting for care planning and resource use. Hearing 
impairment has been associated with lower quality of life, including 
poorer physical, mental, social functioning, and emotional 
health.130 131 Treatment and

[[Page 17669]]

accommodation of hearing impairment led to improved health outcomes, 
including but not limited to quality of life.\132\ For example, hearing 
loss in elderly individuals has been associated with depression and 
cognitive impairment,133 134 135 higher rates of incident 
cognitive impairment and cognitive decline,\136\ and less time in 
occupational therapy.\137\ Accurate assessment of hearing impairment is 
important in the PAC setting for care planning and defining resource 
use.
---------------------------------------------------------------------------

    \130\ Dalton D.S., Cruickshanks K.J., Klein B.E., Klein R, Wiley 
T.L., Nondahl D.M. The impact of hearing loss on quality of life in 
older adults. Gerontologist. 2003;43(5):661-668.
    \131\ Hawkins K., Bottone F.G., Jr., Ozminkowski R.J., et al. 
The prevalence of hearing impairment and its burden on the quality 
of life among adults with Medicare Supplement Insurance. Qual Life 
Res. 2012;21(7):1135-1147.
    \132\ Horn K.L., McMahon N.B., McMahon D.C., Lewis J.S., Barker 
M., Gherini S. Functional use of the Nucleus 22-channel cochlear 
implant in the elderly. The Laryngoscope. 1991;101(3):284-288.
    \133\ Sprinzl G.M., Riechelmann H. Current trends in treating 
hearing loss in elderly people: A review of the technology and 
treatment options--a mini-review. Gerontology. 2010;56(3):351-358.
    \134\ Lin F.R., Thorpe R., Gordon-Salant S., Ferrucci L. Hearing 
Loss Prevalence and Risk Factors Among Older Adults in the United 
States. The Journals of Gerontology Series A: Biological Sciences 
and Medical Sciences. 2011;66A(5):582-590.
    \135\ Hawkins K., Bottone F.G., Jr., Ozminkowski R.J., et al. 
The prevalence of hearing impairment and its burden on the quality 
of life among adults with Medicare Supplement Insurance. Qual Life 
Res. 2012;21(7):1135-1147.
    \136\ Lin F.R., Metter E.J., O'Brien R.J., Resnick S.M., 
Zonderman A.B., Ferrucci L. Hearing Loss and Incident Dementia. Arch 
Neurol. 2011;68(2):214-220.
    \137\ Cimarolli V.R., Jung S. Intensity of Occupational Therapy 
Utilization in Nursing Home Residents: The Role of Sensory 
Impairments. J Am Med Dir Assoc. 2016;17(10):939-942.
---------------------------------------------------------------------------

    The proposed data element consists of the single Hearing data 
element. This data consists of one question that assesses level of 
hearing impairment. This data element is currently in use in the MDS in 
SNFs. For more information on the Hearing data element, we refer 
readers to the document titled ``Proposed Specifications for SNF QRP 
Quality Measures and Standardized Patient Assessment Data Elements,'' 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Hearing data element was first proposed as a SPADE in the FY 
2018 SNF PPS proposed rule (82 FR 21074 through 21075). In that 
proposed rule, we stated that the proposal was informed by input we 
received on the PAC PRD form of the data element (``Ability to Hear'') 
through a call for input published on the CMS Measures Management 
System Blueprint website. Input submitted from August 12 to September 
12, 2016 recommended that hearing, vision, and communication 
assessments be administered at the beginning of patient assessment 
process. A summary report for the August 12 to September 12, 2016 
public comment period titled ``SPADE August 2016 Public Comment Summary 
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported Hearing as a standardized patient assessment 
data element to facilitate care coordination. One stated that coding 
instructions about use of a hearing device by the resident should be 
more clearly defined. Commenters were supportive of adopting the 
Hearing data element for standardized cross-setting use, noting that it 
would help address the needs of patient and residents with disabilities 
and that failing to identify impairments during the initial assessment 
can result in inaccurate diagnoses of impaired language or cognition 
and can validate other information obtained from patient assessment.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Hearing data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the Hearing 
data element to be feasible and reliable for use with PAC patients and 
residents. More information about the performance of the Hearing data 
element in the National Beta Test can be found in the document titled 
``Proposed Specifications for SNF QRP Quality Measures and Standardized 
Patient Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on January 
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs, 
including the Hearing data element. The TEP affirmed the importance of 
standardized assessment of hearing impairment in PAC patients and 
residents. A summary of the January 5 and 6, 2017 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Second Convening)'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. Additionally, a commenter expressed support for the Hearing data 
element and suggested administration at the beginning of the patient 
assessment to maximize utility. A summary of the public input received 
from the November 27, 2018 stakeholder meeting titled ``Input on 
Standardized Patient Assessment Data Elements (SPADEs) Received After 
November 27, 2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for hearing, 
stakeholder input, and strong test results, we are proposing that the 
Hearing data element meets the definition of standardized patient 
assessment data with respect to impairments under section 
1899B(b)(1)(B)(v) of the Act and to adopt the Hearing data element as 
standardized patient assessment data for use in the SNF QRP.
(2) Vision
    We are proposing that the Vision data element meets the definition 
of SPADE with respect to impairments under section 1899B(b)(1)(B)(v) of 
the Act.
    As described in the FY 2018 SNF PPS proposed rule (82 FR 21075 
through 21076), evaluation of an individual's ability to see is 
important for assessing for risks such as falls and provides 
opportunities for improvement through treatment and the provision of 
accommodations, including auxiliary aids and services, which can 
safeguard patients and residents and improve their overall quality of 
life. Further, vision impairment is often a treatable risk factor 
associated with adverse events and poor quality of life. For example, 
individuals with visual impairment are more likely to experience falls 
and hip fracture, have less mobility, and report depressive

[[Page 17670]]

symptoms.138 139 140 141 142 143 144 Individualized initial 
screening can lead to life-improving interventions such as 
accommodations, including the provision of auxiliary aids and services, 
during the stay and/or treatments that can improve vision and prevent 
or slow further vision loss. In addition, vision impairment is often a 
treatable risk factor associated with adverse events which can be 
prevented and accommodated during the stay. Accurate assessment of 
vision impairment is important in the SNF setting for care planning and 
defining resource use.
---------------------------------------------------------------------------

    \138\ Colon-Emeric CS, Biggs DP, Schenck AP, Lyles KW. Risk 
factors for hip fracture in skilled nursing facilities: who should 
be evaluated? Osteoporos Int. 2003;14(6):484-489.
    \139\ Freeman EE, Munoz B, Rubin G, West SK. Visual field loss 
increases the risk of falls in older adults: the Salisbury eye 
evaluation. Invest Ophthalmol Vis Sci. 2007;48(10):4445-4450.
    \140\ Keepnews D, Capitman JA, Rosati RJ. Measuring patient-
level clinical outcomes of home health care. J Nurs Scholarsh. 
2004;36(1):79-85.
    \141\ Nguyen HT, Black SA, Ray LA, Espino DV, Markides KS. 
Predictors of decline in MMSE scores among older Mexican Americans. 
J Gerontol A Biol Sci Med Sci. 2002;57(3):M181-185.
    \142\ Prager AJ, Liebmann JM, Cioffi GA, Blumberg DM. Self-
reported Function, Health Resource Use, and Total Health Care Costs 
Among Medicare Beneficiaries With Glaucoma. JAMA ophthalmology. 
2016;134(4):357-365.
    \143\ Rovner BW, Ganguli M. Depression and disability associated 
with impaired vision: the MoVies Project. J Am Geriatr Soc. 
1998;46(5):617-619.
    \144\ Tinetti ME, Ginter SF. The nursing home life-space 
diameter. A measure of extent and frequency of mobility among 
nursing home residents. J Am Geriatr Soc. 1990;38(12):1311-1315.
---------------------------------------------------------------------------

    The proposed data element consists of the single Vision data 
element (Ability To See in Adequate Light) that consists of one 
question with five response categories. The Vision data element that we 
are proposing for standardization was tested as part of the development 
of the MDS in SNFs and is currently in use in that assessment. Similar 
data elements, but with different wording and fewer response option 
categories, are in use in the OASIS. For more information on the Vision 
data element, we refer readers to the document titled ``Proposed 
Specifications for SNF QRP Quality Measures and Standardized Patient 
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Vision data element was first proposed as a SPADE in the FY 
2018 SNF PPS proposed rule (82 FR 21075 through 21076). In that 
proposed rule, we stated that the proposal was informed by input we 
received on the Ability to See in Adequate Light data element (version 
tested in the PAC PRD with three response categories) through a call 
for input published on the CMS Measures Management System Blueprint 
website. Although the data element in public comment differed from the 
proposed data element, input submitted from August 12 to September 12, 
2016 supported assessing vision in PAC settings and the useful 
information a vision data element would provide. We also stated that 
commenters had noted that the Ability to See item would provide 
important information that would facilitate care coordination and care 
planning, and consequently improve the quality of care. Other 
commenters suggested it would be helpful as an indicator of resource 
use and noted that the item would provide useful information about the 
abilities of patients and residents to care for themselves. Additional 
commenters noted that the item could feasibly be implemented across PAC 
providers and that its kappa scores from the PAC PRD support its 
validity. Some commenters noted a preference for MDS version of the 
Vision data element in SNFs over the form put forward in public 
comment, citing the widespread use of this data element. A summary 
report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the FY 2018 SNF PPS proposed rule, 
two commenters supported Vision as a standardized patient assessment 
data element to facilitate care coordination. One stated that coding 
instructions for use of a vision device by the resident should be more 
clearly defined. Commenters recommended that hearing, vision, and 
communication assessments be administered at the beginning of patient 
assessment process. One commenter supported having a SPADE for vision 
across PAC settings, but stated it captures only basic information for 
risk adjustment, and more detailed information would need to be 
collected to use it as an outcome measure.
    Subsequent to receiving comments on the FY 2018 SNF PPS rule, the 
Vision data element was included in the National Beta Test of candidate 
data elements conducted by our data element contractor from November 
2017 to August 2018. Results of this test found the Vision data element 
to be feasible and reliable for use with PAC patients and residents. 
More information about the performance of the Vision data element in 
the National Beta Test can be found in the document titled ``Proposed 
Specifications for SNF QRP Quality Measures and Standardized Patient 
Assessment Data Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on January 
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs 
including the Vision data element. The TEP affirmed the importance of 
standardized assessment of vision impairment in PAC patients and 
residents. A summary of the January 5 and 6, 2017 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Second Convening)'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our on-going SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. Additionally, a commenter expressed support for the Vision data 
element and suggested administration at the beginning of the patient 
assessment to maximize utility. A summary of the public input received 
from the November 27, 2018 stakeholder meeting titled ``Input on 
Standardized Patient Assessment Data Elements (SPADEs) Received After 
November 27, 2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing for vision, stakeholder 
input, and strong test results, we are proposing that the Vision data 
element meets the definition of standardized patient assessment data 
with respect to

[[Page 17671]]

impairments under section 1899B(b)(1)(B)(v) of the Act and to adopt the 
Vision data element as standardized patient assessment data for use in 
the SNF QRP.
f. Proposed New Category: Social Determinants of Health
(1) Proposed Social Determinants of Health Data Collection To Inform 
Measures and Other Purposes
    Subparagraph (A) of section 2(d)(2) of the IMPACT Act requires CMS 
to assess appropriate adjustments to quality measures, resource 
measures, and other measures, and to assess and implement appropriate 
adjustments to payment under Medicare based on those measures, after 
taking into account studies conducted by ASPE on social risk factors 
(described below) and other information, and based on an individual's 
health status and other factors. Subparagraph (C) of section 2(d)(2) of 
the IMPACT Act further requires the Secretary to carry out periodic 
analyses, at least every three years, based on the factors referred to 
subparagraph (A) so as to monitor changes in possible relationships. 
Subparagraph (B) of section 2(d)(2) of the IMPACT Act requires CMS to 
collect or otherwise obtain access to data necessary to carry out the 
requirement of the paragraph (both assessing adjustments described 
above in such subparagraph (A) and for periodic analyses in such 
subparagraph (C)). Accordingly we are proposing to use our authority 
under subparagraph (B) of section 2(d)(2) of the IMPACT Act to 
establish a new data source for information to meet the requirements of 
subparagraphs (A) and (C) of section 2(d)(2) of the IMPACT Act. In this 
rule, we are proposing to collect and access data about social 
determinants of health (SDOH) to perform CMS' responsibilities under 
subparagraphs (A) and (C) of section 2(d)(2) of the IMPACT Act, as 
explained in more detail below. Social determinants of health, also 
known as social risk factors, or health-related social needs, are the 
socioeconomic, cultural and environmental circumstances in which 
individuals live that impact their health. We are proposing to collect 
information on seven proposed SDOH SPADE data elements relating to 
race, ethnicity, preferred language, interpreter services, health 
literacy, transportation, and social isolation; a detailed discussion 
of each of the proposed SDOH data elements is found in section 
VI.A.7.f.(2) of this proposed rule.
    We are also proposing to use the resident assessment instrument 
minimum data set (MDS), the current version being MDS 3.0, described as 
a PAC assessment instrument under section 1899B(a)(2)(B) of the Act, to 
collect these data via an existing data collection mechanism. We 
believe this approach will provide CMS with access to data with respect 
to the requirements of section 2(d)(2) of the IMPACT Act, while 
minimizing the reporting burden on PAC health care providers by relying 
on a data reporting mechanism already used and an existing system to 
which PAC health care providers are already accustomed.
    The IMPACT Act includes several requirements applicable to the 
Secretary, in addition to those imposing new data reporting obligations 
on certain PAC providers as discussed in section VI.A.7.f.(2) of this 
proposed rule. Subparagraphs (A) and (B) of section 2(d)(1) of the 
IMPACT Act require the Secretary, acting through the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE), to conduct two 
studies that examine the effect of risk factors, including individuals' 
socioeconomic status, on quality, resource use and other measures under 
the Medicare program. The first ASPE study was completed in December 
2016 and is discussed below, and the second study is to be completed in 
the fall of 2019. We recognize that ASPE, in its studies, is 
considering a broader range of social risk factors than the SDOH data 
elements in this proposal, and address both PAC and non-PAC settings. 
We acknowledge that other data elements may be useful to understand, 
and that some of those elements may be of particular interest in non-
PAC settings. For example, for beneficiaries receiving care in the 
community, as opposed to an in-patient facility, housing stability and 
food insecurity may be more relevant. We will continue to take into 
account the findings from both of ASPE's reports in future policy 
making.
    One of the ASPE's first actions under the IMPACT Act was to 
commission the National Academies of Sciences, Engineering, and 
Medicine (NASEM) to define and conceptualize socioeconomic status for 
the purposes of ASPE's two studies under section 2(d)(1) of the IMPACT 
Act. The NASEM convened a panel of experts in the field and conducted 
an extensive literature review. Based on the information collected, the 
2016 NASEM panel report titled, ``Accounting for Social Risk Factors in 
Medicare Payment: Identifying Social Risk Factors,'' concluded that the 
best way to assess how social processes and social relationships 
influence key health-related outcomes in Medicare beneficiaries is 
through a framework of social risk factors instead of socioeconomic 
status. Social risk factors discussed in the NASEM report include 
socioeconomic position, race, ethnicity, gender, social context, and 
community context. These factors are discussed at length in chapter 2 
of the NASEM report, titled ``Social Risk Factors.'' \145\ Consequently 
NASEM framed the results of its report in terms of ``social risk 
factors'' rather than ``socioeconomic status'' or ``sociodemographic 
status.'' The full text of the ``Social Risk Factors'' NASEM report is 
available for reading on the website at https://www.nap.edu/read/21858/chapter/1.
---------------------------------------------------------------------------

    \145\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for social risk factors in Medicare payment: 
Identifying social risk factors. Chapter 2. Washington, DC: The 
National Academies Press.
---------------------------------------------------------------------------

    Each of the data elements we are proposing to collect and access 
pursuant to our authority under section 2(d)(2)(B) of the IMPACT Act is 
identified in the 2016 NASEM report as a social risk factor that has 
been shown to impact care use, cost and outcomes for Medicare 
beneficiaries. CMS uses the term social determinants of health (SDOH) 
to denote social risk factors, which is consistent with the objectives 
of Healthy People 2020.\146\
---------------------------------------------------------------------------

    \146\ Social Determinants of Health. Healthy People 2020. 
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
---------------------------------------------------------------------------

    ASPE issued its first Report to Congress, titled ``Social Risk 
Factors and Performance Under Medicare's Value-Based Purchasing 
Programs,'' pursuant to section 2(d)(1)(A) of the IMPACT Act on 
December 21, 2016.\147\ Using NASEM's social risk factors framework, 
ASPE focused on the following social risk factors, in addition to 
disability: (1) Dual enrollment in Medicare and Medicaid as a marker 
for low income, (2) residence in a low-income area, (3) Black race, (4) 
Hispanic ethnicity, and; (5) residence in a rural area. ASPE 
acknowledged that the social risk factors examined in its report were 
limited due to data availability. The report also noted that the data 
necessary to meaningfully attempt to reduce disparities and identify 
and reward improved outcomes for beneficiaries with social risk factors 
have not been collected consistently on a national level in post-acute 
care settings. Where these data have been collected, the

[[Page 17672]]

collection frequently involves lengthy questionnaires. More information 
on the Report to Congress on Social Risk Factors and Performance under 
Medicare's Value-Based Purchasing Programs, including the full report, 
is available on the website at https://aspe.hhs.gov/social-risk-factors-and-medicares-value-based-purchasing-programs-reports.
---------------------------------------------------------------------------

    \147\ U.S. Department of Health and Human Services, Office of 
the Assistant Secretary for Planning and Evaluation. 2016. Report to 
Congress: Social Risk Factors and Performance Under Medicare's 
Value-Based Payment Programs. Washington, DC.
---------------------------------------------------------------------------

    Section 2(d)(2) of the IMPACT Act relates to CMS activities and 
imposes several responsibilities on the Secretary relating to quality, 
resource use, and other measures under Medicare. As mentioned 
previously, under subparagraph (A) of section 2(d)(2) of the IMPACT 
Act, the Secretary is required, on an ongoing basis, taking into 
account the ASPE studies and other information, and based on an 
individual's health status and other factors, to assess appropriate 
adjustments to quality, resource use, and other measures, and to assess 
and implement appropriate adjustments to Medicare payments based on 
those measures. Section 2(d)(2)(A)(i) of the IMPACT Act applies to 
measures adopted under subsections (c) and (d) of section 1899B of the 
Act and to other measures under Medicare. However, CMS' ability to 
perform these analyses, and assess and make appropriate adjustments is 
hindered by limits of existing data collections on SDOH data elements 
for Medicare beneficiaries. In its first study in 2016, in discussing 
the second study, ASPE noted that information relating to many of the 
specific factors listed in the IMPACT Act, such as health literacy, 
limited English proficiency, and Medicare beneficiary activation, are 
not available in Medicare data.
    Subparagraph 2(d)(2)(A) of the IMPACT Act specifically requires the 
Secretary to take the studies and considerations from ASPE's reports to 
Congress, as well as other information as appropriate, into account in 
assessing and implementing adjustments to measures and related payments 
based on measures in Medicare. The results of the ASPE's first study 
demonstrated that Medicare beneficiaries with social risk factors 
tended to have worse outcomes on many quality measures, and providers 
who treated a disproportionate share of beneficiaries with social risk 
factors tended to have worse performance on quality measures. As a 
result of these findings, ASPE suggested a three-pronged strategy to 
guide the development of value-based payment programs under which all 
Medicare beneficiaries receive the highest quality healthcare services 
possible. The three components of this strategy are to: (1) Measure and 
report quality of care for beneficiaries with social risk factors; (2) 
set high, fair quality standards for care provided to all 
beneficiaries; and (3) reward and support better outcomes for 
beneficiaries with social risk factors. In discussing how measuring and 
reporting quality for beneficiaries with social risk factors can be 
applied to Medicare quality payment programs, the report offered nine 
considerations across the three-pronged strategy, including enhancing 
data collection and developing statistical techniques to allow 
measurement and reporting of performance for beneficiaries with social 
risk factors on key quality and resource use measures.
    Congress, in section 2(d)(2)(B) of the IMPACT Act, required the 
Secretary to collect or otherwise obtain access to the data necessary 
to carry out the provisions of paragraph (2) of section 2(d) of the 
IMPACT Act through both new and existing data sources. Taking into 
consideration NASEM's conceptual framework for social risk factors 
discussed above, ASPE's study, considerations under section 2(d)(1)(A) 
of the IMPACT Act, as well as the current data constraints of ASPE's 
first study and its suggested considerations, we are proposing to 
collect and access data about SDOH under section 2(d)(2) of the IMPACT 
Act. Our collection and use of the SDOH data described in section 
VI.A.7.f.(1) of this proposed rule, under section 2(d)(2) of the IMPACT 
Act, would be independent of our proposal below (in section 
VI.A.7.f.(2) of this proposed rule and our authority to require 
submission of that data for use as SPADE under section 1899B(a)(1)(B) 
of the Act.
    Accessing standardized data relating to the SDOH data elements on a 
national level is necessary to permit CMS to conduct periodic analyses, 
to assess appropriate adjustments to quality measures, resource use 
measures, and other measures, and to assess and implement appropriate 
adjustments to Medicare payments based on those measures. We agree with 
ASPE's observations, in the value-based purchasing context, that the 
ability to measure and track quality, outcomes, and costs for 
beneficiaries with social risk factors over time is critical as 
policymakers and providers seek to reduce disparities and improve care 
for these groups. Collecting the data as proposed will provide the 
basis for our periodic analyses of the relationship between an 
individual's health status and other factors and quality, resource use, 
and other measures, as required by section 2(d)(2) of the IMPACT Act, 
and to assess appropriate adjustments. These data will also permit us 
to develop the statistical tools necessary to maximize the value of 
Medicare data, reduce costs and improve the quality of care for all 
beneficiaries. Collecting and accessing SDOH data in this way also 
supports the three-part strategy put forth in the first ASPE report, 
specifically ASPE's consideration to enhance data collection and 
develop statistical techniques to allow measurement and reporting of 
performance for beneficiaries with social risk factors on key quality 
and resource use measures.
    For the reasons discussed above, we are proposing under section 
2(d)(2) of the IMPACT Act, to collect the data on the following SDOH: 
(1) Race, as described in section VI.A.7.f.(2)(a) of this proposed 
rule; (2) Ethnicity, as described in section VI.A.7.f.(2)(a) of this 
proposed rule; (3) Preferred Language, as described in section 
VI.A.7.f.(2)(b) of this proposed rule; (4) Interpreter Services as 
described in section VI.A.7.f.(2)(b) of this proposed rule; (5) Health 
Literacy, as described in section VI.A.7.f.(2)(c) of this proposed 
rule; (6) Transportation, as described in section VI.A.7.f.(2)(d) of 
this proposed rule; and (5) Social Isolation, as described in section 
VI.A.7.f.(2)(e) of this proposed rule. These data elements are 
discussed in more detail below in section VI.A.7.f.(2) of this proposed 
rule. We welcome comment on this proposal.
(2) Standardized Patient Assessment Data
    Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to 
collect SPADEs with respect to other categories deemed necessary and 
appropriate. Below we are proposing to create a Social Determinants of 
Health SPADE category under section 1899B(b)(1)(B)(vi) of the Act. In 
addition to collecting SDOH data for the purposes outlined above under 
section 2(d)(2)(B) of the IMPACT Act, we are also proposing to collect 
as SPADE these same data elements (race, ethnicity, preferred language, 
interpreter services, health literacy, transportation, and social 
isolation) under section 1899B(b)(1)(B)(vi) of the Act. We believe that 
this proposed new category of Social Determinants of Health will inform 
provider understanding of individual patient risk factors and treatment 
preferences, facilitate coordinated care and care planning, and improve 
patient outcomes. We are proposing to deem this category necessary and 
appropriate, for the purposes of SPADE, because using common standards 
and definitions for

[[Page 17673]]

PAC data elements is important in ensuring interoperable exchange of 
longitudinal information between PAC providers and other providers to 
facilitate coordinated care, continuity in care planning, and the 
discharge planning process from post-acute care settings.
    All of the Social Determinants of Health data elements we are 
proposing under section 1899B(b)(1)(B)(vi) of the Act have the capacity 
to take into account treatment preferences and care goals of residents 
and patients, and to inform our understanding of resident and patient 
complexity and risk factors that may affect care outcomes. While 
acknowledging the existence and importance of additional SDOH, we are 
proposing to assess some of the factors relevant for patients and 
residents receiving post-acute care that PAC settings are in a position 
to impact through the provision of services and supports, such as 
connecting patients and residents with identified needs with 
transportation programs, certified interpreters, or social support 
programs.
    As previously mentioned and described in more detail below we are 
proposing to adopt the following seven data elements as SPADE under the 
proposed Social Determinants of Health category: Race, ethnicity, 
preferred language, interpreter services, health literacy, 
transportation, and social isolation. To select these data elements, we 
reviewed the research literature, a number of validated assessment 
tools and frameworks for addressing SDOH currently in use (for example, 
Health Leads, NASEM, Protocol for Responding to and Assessing Patients' 
Assets, Risks, and Experiences (PRAPARE), and ICD-10), and we engaged 
in discussions with stakeholders. We also prioritized balancing the 
reporting burden for PAC providers with our policy objective to collect 
SPADEs that will inform care planning and coordination and quality 
improvement across care settings. Furthermore, incorporating SDOH data 
elements into care planning has the potential to reduce readmissions 
and help beneficiaries achieve and maintain their health goals.
    We also considered feedback received during a listening session 
that we held on December 13, 2018. The purpose of the listening session 
was to solicit feedback from health systems, research organizations, 
advocacy organizations and state agencies, and other members of the 
public on collecting patient-level data on SDOH across care settings, 
including consideration of race, ethnicity, spoken language, health 
literacy, social isolation, transportation, sex, gender identity, and 
sexual orientation. We also gave participants an option to submit 
written comments. A full summary of the listening session, titled 
``Listening Session on Social Determinants of Health Data Elements: 
Summary of Findings,'' includes a list of participating stakeholders 
and their affiliations, and is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(a) Race and Ethnicity
    The persistence of racial and ethnic disparities in health and 
health care is widely documented, including in PAC 
settings.148 149 150 151 152 Despite the trend toward 
overall improvements in quality of care and health outcomes, the Agency 
for Healthcare Research and Quality, in its National Healthcare Quality 
and Disparities Reports, consistently indicates that racial and ethnic 
disparities persist, even after controlling for factors such as income, 
geography, and insurance.\153\ For example, racial and ethnic 
minorities tend to have higher rates of infant mortality, diabetes and 
other chronic conditions, and visits to the emergency department, and 
lower rates of having a usual source of care and receiving 
immunizations such as the flu vaccine.\154\ Studies have also shown 
that African Americans are significantly more likely than white 
Americans to die prematurely from heart disease and stroke.\155\ 
However, our ability to identify and address racial and ethnic health 
disparities has historically been constrained by data limitations, 
particularly for smaller populations groups such as Asians, American 
Indians and Alaska Natives, and Native Hawaiians and other Pacific 
Islanders.\156\
---------------------------------------------------------------------------

    \148\ 2017 National Healthcare Quality and Disparities Report. 
Rockville, MD: Agency for Healthcare Research and Quality; September 
2018. AHRQ Pub. No. 18-0033-EF.
    \149\ Fiscella, K. and Sanders, M.R. Racial and Ethnic 
Disparities in the Quality of Health Care. (2016). Annual Review of 
Public Health. 37:375-394.
    \150\ 2018 National Impact Assessment of the Centers for 
Medicare & Medicaid Services (CMS) Quality Measures Reports. 
Baltimore, MD: U.S. Department of Health and Human Services, Centers 
for Medicare and Medicaid Services; February 28, 2018.
    \151\ Smedley, B.D., Stith, A.Y., & Nelson, A.R. (2003). Unequal 
treatment: confronting racial and ethnic disparities in health care. 
Washington, DC, National Academy Press.
    \152\ Chase, J., Huang, L. and Russell, D. (2017). Racial/ethnic 
disparities in disability outcomes among post-acute home care 
patients. J of Aging and Health. 30(9):1406-1426.
    \153\ National Healthcare Quality and Disparities Reports. 
(December 2018). Agency for Healthcare Research and Quality, 
Rockville, MD. http://www.ahrq.gov/research/findings/nhqrdr/index.html.
    \154\ National Center for Health Statistics. Health, United 
States, 2017: With special feature on mortality. Hyattsville, 
Maryland. 2018.
    \155\ HHS. Heart disease and African Americans. 2016b. (October 
24, 2016). http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
    \156\ National Academies of Sciences, Engineering, and Medicine; 
Health and Medicine Division; Board on Population Health and Public 
Health Practice; Committee on Community-Based Solutions to Promote 
Health Equity in the United States; Baciu A, Negussie Y, Geller A, 
et al., editors. Communities in Action: Pathways to Health Equity. 
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The 
State of Health Disparities in the United States. Available from: 
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
---------------------------------------------------------------------------

    The ability to improve understanding of and address racial and 
ethnic disparities in PAC outcomes requires the availability of better 
data. There is currently a Race and Ethnicity data element, collected 
in the MDS, LCDS, IRF-PAI, and OASIS, that consists of a single 
question, which aligns with the 1997 Office of Management and Budget 
(OMB) minimum data standards for federal data collection efforts.\157\ 
The 1997 OMB Standard lists five minimum categories of race: (1) 
American Indian or Alaska Native; (2) Asian; (3) Black or African 
American; (4) Native Hawaiian or Other Pacific Islander; (5) and White. 
The 1997 OMB Standard also lists two minimum categories of ethnicity: 
(1) Hispanic or Latino, and (2) Not Hispanic or Latino. The 2011 HHS 
Data Standards requires a two-question format when self-identification 
is used to collect data on race and ethnicity. Large federal surveys 
such as the National Health Interview Survey, Behavioral Risk Factor 
Surveillance System, and the National Survey on Drug Use and Health, 
have implemented the 2011 HHS race and ethnicity data standards. CMS 
has similarly updated the Medicare Current Beneficiary Survey, Medicare 
Health Outcomes Survey, and the Health Insurance Marketplace 
Application for Health Coverage with the 2011 HHS data standards. More 
information about the HHS Race and Ethnicity Data Standards are 
available on the website at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
---------------------------------------------------------------------------

    \157\ ``Revisions to the Standards for the Classification of 
Federal Data on Race and Ethnicity (Notice of Decision)''. Federal 
Register 62:210 (October 30, 1997) pp. 58782-58790. Available from: 
https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf.
---------------------------------------------------------------------------

    We are proposing to revise the current Race and Ethnicity data 
element for purposes of this proposal to conform to the 2011 HHS Data 
Standards for person-level data collection, while also meeting the 1997 
OMB minimum data

[[Page 17674]]

standards for race and ethnicity. Rather than one data element that 
assesses both race and ethnicity, we are proposing two separate data 
elements: One for Race and one for Ethnicity, that would conform with 
the 2011 HHS Data Standards and the 1997 OMB Standard. In accordance 
with the 2011 HHS Data Standards, a two-question format would be used 
for the proposed race and ethnicity data elements.
    The proposed Race data element asks, ``What is your race?'' We are 
proposing to include fourteen response options under the race data 
element: (1) White; (2) Black or African American; (3) American Indian 
or Alaska Native; (4) Asian Indian; (5) Chinese; (6) Filipino; (7) 
Japanese; (8) Korean; (9) Vietnamese; (10) Other Asian; (11) Native 
Hawaiian; (12) Guamanian or Chamorro; (13) Samoan; and, (14) Other 
Pacific Islander.
    The proposed Ethnicity data element asks, ``Are you Hispanic, 
Latino/a, or Spanish origin?'' We are proposing to include five 
response options under the ethnicity data element: (1) Not of Hispanic, 
Latino/a, or Spanish origin; (2) Mexican, Mexican American, Chicano/a; 
(3) Puerto Rican; (4) Cuban; and, (5) Another Hispanic, Latino, or 
Spanish Origin.
    We believe that the two proposed data elements for race and 
ethnicity conform to the 2011 HHS Data Standards for person-level data 
collection, while also meeting the 1997 OMB minimum data standards for 
race and ethnicity, because under those standards, more detailed 
information on population groups can be collected if those additional 
categories can be aggregated into the OMB minimum standard set of 
categories.
    In addition, we received stakeholder feedback during the December 
13, 2018 SDOH listening session on the importance of improving response 
options for race and ethnicity as a component of health care 
assessments and for monitoring disparities. Some stakeholders 
emphasized the importance of allowing for self-identification of race 
and ethnicity for more categories than are included in the 2011 HHS 
Standard to better reflect state and local diversity, while 
acknowledging the burden of coding an open-ended health care assessment 
question across different settings.
    We believe that the proposed modified race and ethnicity data 
elements more accurately reflect the diversity of the U.S. population 
than the current race/ethnicity data element included in MDS, LCDS, 
IRF-PAI and, OASIS.158 159 160 161 We believe, and research 
consistently shows, that improving how race and ethnicity data are 
collected is an important first step in improving quality of care and 
health outcomes. Addressing disparities in access to care, quality of 
care, and health outcomes for Medicare beneficiaries begins with 
identifying and analyzing how SDOH, such as race and ethnicity, align 
with disparities in these areas.\162\ Standardizing self-reported data 
collection for race and ethnicity allows for the equal comparison of 
data across multiple healthcare entities.\163\ By collecting and 
analyzing these data, CMS and other healthcare entities will be able to 
identify challenges and monitor progress. The growing diversity of the 
US population and knowledge of racial and ethnic disparities within and 
across population groups supports the collection of more granular data 
beyond the 1997 OMB minimum standard for reporting categories. The 2011 
HHS race and ethnicity data standard includes additional detail that 
may be used by PAC providers to target quality improvement efforts for 
racial and ethnic groups experiencing disparate outcomes. For more 
information on the Race and Ethnicity data elements, we refer readers 
to the document titled ``Proposed Specifications for SNF QRP Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \158\ Penman-Aguilar, A., Talih, M., Huang, D., Moonesinghe, R., 
Bouye, K., Beckles, G. (2016). Measurement of Health Disparities, 
Health Inequities, and Social Determinants of Health to Support the 
Advancement of Health Equity. J Public Health Manag Pract. 22 Suppl 
1: S33-42.
    \159\ Ramos, R., Davis, J.L., Ross, T., Grant, C.G., Green, B.L. 
(2012). Measuring health disparities and health inequities: do you 
have REGAL data? Qual Manag Health Care. 21(3):176-87.
    \160\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement. 
Washington, DC: The National Academies Press.
    \161\ ``Revision of Standards for Maintaining, Collecting, and 
Presenting Federal Data on Race and Ethnicity: Proposals From 
Federal Interagency Working Group (Notice and Request for 
Comments).'' Federal Register 82: 39 (March 1, 2017) p. 12242.
    \162\ National Academies of Sciences, Engineering, and Medicine; 
Health and Medicine Division; Board on Population Health and Public 
Health Practice; Committee on Community-Based Solutions to Promote 
Health Equity in the United States; Baciu A, Negussie Y, Geller A, 
et al., editors. Communities in Action: Pathways to Health Equity. 
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The 
State of Health Disparities in the United States. Available from: 
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
    \163\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement. 
Washington, DC: The National Academies Press.
---------------------------------------------------------------------------

    In an effort to standardize the submission of race and ethnicity 
data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in 
section 1899B(a)(1)(B) of the Act, while minimizing the reporting 
burden, we are proposing to adopt the Race and Ethnicity data elements 
described above as SPADEs with respect to the proposed Social 
Determinants of Health category.
    Specifically, we are proposing to replace the current Race/
Ethnicity data element with the proposed Race and Ethnicity data 
elements on the MDS. We are also proposing that SNFs that submit the 
Race and Ethnicity data elements with respect to admission will be 
considered to have submitted with respect to discharge as well, because 
it is unlikely that the results of these assessment findings will 
change between the start and end of the SNF stay, making the 
information submitted with respect to a resident's admission the same 
with respect to a resident's discharge.
(b) Preferred Language and Interpreter Services
    More than 64 million Americans speak a language other than English 
at home, and nearly 40 million of those individuals have limited 
English proficiency (LEP).\164\ Individuals with LEP have been shown to 
receive worse care and have poorer health outcomes, including higher 
readmission rates.165 166 167 Communication with individuals 
with LEP is an important component of high quality health care, which 
starts by understanding the population in need of language services. 
Unaddressed language barriers between a patient and provider care team 
negatively affects the ability to identify and address individual 
medical and non-medical care needs, to convey and understand clinical 
information, as well as discharge and follow up instructions, all of 
which are necessary for providing

[[Page 17675]]

high quality care. Understanding the communication assistance needs of 
residents and patients with LEP, including individuals who are Deaf or 
hard of hearing, is critical for ensuring good outcomes.
---------------------------------------------------------------------------

    \164\ U.S. Census Bureau, 2013-2017 American Community Survey 5-
Year Estimates.
    \165\ Karliner LS, Kim SE, Meltzer DO, Auerbach AD. Influence of 
language barriers on outcomes of hospital care for general medicine 
inpatients. J Hosp Med. 2010 May-Jun;5(5):276-82. doi: 10.1002/
jhm.658.
    \166\ Kim EJ, Kim T, Paasche-Orlow MK, et al. Disparities in 
Hypertension Associated with Limited English Proficiency. J Gen 
Intern Med. 2017 Jun;32(6):632-639. doi: 10.1007/s11606-017-3999-9.
    \167\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for social risk factors in Medicare payment: 
Identifying social risk factors. Washington, DC: The National 
Academies Press.
---------------------------------------------------------------------------

    Presently, the preferred language of residents and patients and 
need for interpreter services are assessed in two PAC assessment tools. 
The LCDS and the MDS use the same two data elements to assess preferred 
language and whether a patient or resident needs or wants an 
interpreter to communicate with health care staff. The MDS initially 
implemented preferred language and interpreter services data elements 
to assess the needs of SNF residents and patients and inform care 
planning. For alignment purposes, the LCDS later adopted the same data 
elements for LTCHs. The 2009 NASEM (formerly Institute of Medicine) 
report on standardizing data for health care quality improvement 
emphasizes that language and communication needs should be assessed as 
a standard part of health care delivery and quality improvement 
strategies.\168\
---------------------------------------------------------------------------

    \168\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement. 
Washington, DC: The National Academies Press.
---------------------------------------------------------------------------

    In developing our proposal for a standardized language data element 
across PAC settings, we considered the current preferred language and 
interpreter services data elements that are in LCDS and MDS. We also 
considered the 2011 HHS Primary Language Data Standard and peer-
reviewed research. The current preferred language data element in LCDS 
and MDS asks, ``What is your preferred language?'' Because the 
preferred language data element is open-ended, the patient or resident 
is able to identify their preferred language, including American Sign 
Language (ASL). Finally, we considered the recommendations from the 
2009 NASEM (formerly Institute of Medicine) report, ``Race, Ethnicity, 
and Language Data: Standardization for Health Care Quality 
Improvement.'' In it, the committee recommended that organizations 
evaluating a patient's language and communication needs for health care 
purposes, should collect data on the preferred spoken language and on 
an individual's assessment of his/her level of English proficiency.
    A second language data element in LCDS and MDS asks, ``Do you want 
or need an interpreter to communicate with a doctor or health care 
staff?'' and includes yes or no response options. In contrast, the 2011 
HHS Primary Language Data Standard recommends either a single question 
to assess how well someone speaks English or, if more granular 
information is needed, a two-part question to assess whether a language 
other than English is spoken at home and if so, identify that language. 
However, neither option allows for a direct assessment of a patient's 
or resident's preferred spoken or written language nor whether they 
want or need interpreter services for communication with a doctor or 
care team, both of which are an important part of assessing resident 
and patient needs and the care planning process. More information about 
the HHS Data Standard for Primary Language is available on the website 
at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
    Research consistently recommends collecting information about an 
individual's preferred spoken language and evaluating those responses 
for purposes of determining language access needs in health care.\169\ 
However, using ``preferred spoken language'' as the metric does not 
adequately account for people whose preferred language is ASL, which 
would necessitate adopting an additional data element to identify 
visual language. The need to improve the assessment of language 
preferences and communication needs across PAC settings should be 
balanced with the burden associated with data collection on the 
provider and patient or resident. Therefore we are proposing to retain 
the Preferred Language and Interpreter Services data elements currently 
in use on the MDS.
---------------------------------------------------------------------------

    \169\ Guerino, P. and James, C. Race, Ethnicity, and Language 
Preference in the Health Insurance Marketplaces 2017 Open Enrollment 
Period. Centers for Medicare & Medicaid Services, Office of Minority 
Health. Data Highlight: Volume 7--April 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf.
---------------------------------------------------------------------------

    In addition, we received feedback during the December 13, 2018 
listening session on the importance of evaluating and acting on 
language preferences early to facilitate communication and allowing for 
patient self-identification of preferred language. Although the 
discussion about language was focused on preferred spoken language, 
there was general consensus among participants that stated language 
preferences may or may not accurately indicate the need for interpreter 
services, which supports collecting and evaluating data to determine 
language preference, as well as the need for interpreter services. An 
alternate suggestion was made to inquire about preferred language 
specifically for discussing health or health care needs. While this 
suggestion does allow for ASL as a response option, we do not have data 
indicating how useful this question might be for assessing the desired 
information and thus we are not including this question in our 
proposal.
    Improving how preferred language and need for interpreter services 
data are collected is an important component of improving quality by 
helping PAC providers and other providers understand patient needs and 
develop plans to address them. For more information on the Preferred 
Language and Interpreter Services data elements, we refer readers to 
the document titled ``Proposed Specifications for SNF QRP Measures and 
Standardized Patient Assessment Data Elements,'' available on the 
website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of language data among 
IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we 
are proposing to adopt the Preferred Language and Interpreter Services 
data elements currently used on the MDS, and describe above, as SPADEs 
with respect to the Social Determinants of Health category.
(c) Health Literacy
    The Department of Health and Human Services defines health literacy 
as ``the degree to which individuals have the capacity to obtain, 
process, and understand basic health information and services needed to 
make appropriate health decisions.'' \170\ Similar to language 
barriers, low health literacy can interfere with communication between 
the provider and resident or patient and the ability for residents and 
patients or their caregivers to understand and follow treatment plans, 
including medication management. Poor health literacy is linked to 
lower levels of knowledge about health, worse health outcomes, and the 
receipt of fewer preventive services, but higher medical costs and 
rates of emergency department use.\171\
---------------------------------------------------------------------------

    \170\ U.S. Department of Health and Human Services, Office of 
Disease Prevention and Health Promotion. National action plan to 
improve health literacy. Washington (DC): Author; 2010.
    \171\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for social risk factors in Medicare payment: 
Identifying social risk factors. Washington, DC: The National 
Academies Press.

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

[[Page 17676]]

    Health literacy is prioritized by Healthy People 2020 as an 
SDOH.\172\ Healthy People 2020 is a long-term, evidence-based effort 
led by the Department of Health and Human Services that aims to 
identify nationwide health improvement priorities and improve the 
health of all Americans. Although not designated as a social risk 
factor in NASEM's 2016 report on accounting for social risk factors in 
Medicare payment, the NASEM noted that health literacy is impacted by 
other social risk factors and can affect access to care as well as 
quality of care and health outcomes.\173\ Assessing for health literacy 
across PAC settings would facilitate better care coordination and 
discharge planning. A significant challenge in assessing the health 
literacy of individuals is avoiding excessive burden on patients and 
residents and health care providers. The majority of existing, 
validated health literacy assessment tools use multiple screening 
items, generally with no fewer than four, which would make them 
burdensome if adopted in MDS, LCDS, IRF-PAI, and OASIS.
---------------------------------------------------------------------------

    \172\ Social Determinants of Health. Healthy People 2020. 
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
    \173\ U.S. Department of Health & Human Services, Office of the 
Assistant Secretary for Planning and Evaluation. Report to Congress: 
Social Risk Factors and Performance Under Medicare's Value-Based 
Purchasing Programs. Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs. Washington, DC: 2016.
---------------------------------------------------------------------------

    The Single Item Literacy Screener (SILS) question asks, ``How often 
do you need to have someone help you when you read instructions, 
pamphlets, or other written material from your doctor or pharmacy?'' 
Possible response options are: (1) Never; (2) Rarely; (3) Sometimes; 
(4) Often; and (5) Always. The SILS question, which assesses reading 
ability, (a primary component of health literacy), tested reasonably 
well against the 36 item Short Test of Functional Health Literacy in 
Adults (S-TOFHLA), a thoroughly vetted and widely adopted health 
literacy test, in assessing the likelihood of low health literacy in an 
adult sample from primary care practices participating in the Vermont 
Diabetes Information System.174 175 The S-TOFHLA is a more 
complex assessment instrument developed using actual hospital related 
materials such as prescription bottle labels and appointment slips, and 
often considered the instrument of choice for a detailed evaluation of 
health literacy.\176\ Furthermore, the S-TOFHLA instrument is 
proprietary and subject to purchase for individual entities or 
users.\177\ Given that SILS is publicly available, shorter and easier 
to administer than the full health literacy screen, and research found 
that a positive result on the SILS demonstrates an increased likelihood 
that an individual has low health literacy, we are proposing to use the 
single-item reading question for health literacy in the standardized 
data collection across PAC settings. We believe that use of this data 
element will provide sufficient information about the health literacy 
of SNF residents to facilitate appropriate care planning, care 
coordination, and interoperable data exchange across PAC settings.
---------------------------------------------------------------------------

    \174\ Morris, N.S., MacLean, C.D., Chew, L.D., & Littenberg, B. 
(2006). The Single Item Literacy Screener: evaluation of a brief 
instrument to identify limited reading ability. BMC family practice, 
7, 21. doi:10.1186/1471-2296-7-21.
    \175\ Brice, J.H., Foster, M.B., Principe, S., Moss, C., Shofer, 
F.S., Falk, R.J., Ferris, M.E., DeWalt, D.A. (2013). Single-item or 
two-item literacy screener to predict the S-TOFHLA among adult 
hemodialysis patients. Patient Educ Couns. 94(1):71-5.
    \176\ University of Miami, School of Nursing & Health Studies, 
Center of Excellence for Health Disparities Research. Test of 
Functional Health Literacy in Adults (TOFHLA). (March 2019). 
Available at https://elcentro.sonhs.miami.edu/research/measures-library/tofhla/index.html.
    \177\ Nurss, J.R., Parker, R.M., Williams, M.V., & Baker, D.W. 
David W. (2001). TOFHLA. Peppercorn Books & Press. Available from: 
http://www.peppercornbooks.com/catalog/information.php?info_id=5.
---------------------------------------------------------------------------

    In addition, we received feedback during the December 13, 2018 SDOH 
listening session on the importance of recognizing health literacy as 
more than understanding written materials and filling out forms, as it 
is also important to evaluate whether patients and residents understand 
their conditions. However, the NASEM recently recommended that health 
care providers implement health literacy universal precautions instead 
of taking steps to ensure care is provided at an appropriate literacy 
level based on individualized assessment of health literacy.\178\ Given 
the dearth of Medicare data on health literacy and gaps in addressing 
health literacy in practice, we recommend the addition of a health 
literacy data element.
---------------------------------------------------------------------------

    \178\ Hudson, S., Rikard, R.V., Staiculescu, I. & Edison, K. 
(2017). Improving health and the bottom line: The case for health 
literacy. In Building the case for health literacy: Proceedings of a 
workshop. Washington, DC: The National Academies Press.
---------------------------------------------------------------------------

    The proposed Health Literacy data element is consistent with 
considerations raised by NASEM and other stakeholders and research on 
health literacy, which demonstrates an impact on health care use, cost, 
and outcomes.\179\ For more information on the proposed Health Literacy 
data element, we refer readers to the document titled ``Proposed 
Specifications for SNF QRP Measures and Standardized Patient Assessment 
Data Elements,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \179\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for Social Risk Factors in Medicare Payment: 
Identifying Social Risk Factors. Washington, DC: The National 
Academies Press.
---------------------------------------------------------------------------

    In an effort to standardize the submission of health literacy data 
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we 
are proposing to adopt the SILS question, described above for the 
Health Literacy data element, as SPADE under the Social Determinants of 
Health Category. We are proposing to add the Health Literacy data 
element to the MDS.
(d) Transportation
    Transportation barriers commonly affect access to necessary health 
care, causing missed appointments, delayed care, and unfilled 
prescriptions, all of which can have a negative impact on health 
outcomes.\180\ Access to transportation for ongoing health care and 
medication access needs, particularly for those with chronic diseases, 
is essential to successful chronic disease management. Adopting a data 
element to collect and analyze information regarding transportation 
needs across PAC settings would facilitate the connection to programs 
that can address identified needs. We are therefore proposing to adopt 
as SPADE a single transportation data element that is from the Protocol 
for Responding to and Assessing Patients' Assets, Risks, and 
Experiences (PRAPARE) assessment tool and currently part of the 
Accountable Health Communities (AHC) Screening Tool.
---------------------------------------------------------------------------

    \180\ Syed, S.T., Gerber, B.S., and Sharp, L.K. (2013). 
Traveling Towards Disease: Transportation Barriers to Health Care 
Access. J Community Health. 38(5): 976-993.
---------------------------------------------------------------------------

    The proposed Transportation data element from the PRAPARE tool 
asks, ``Has lack of transportation kept you from medical appointments, 
meetings, work, or from getting things needed for daily living?'' The 
three response options are: (1) Yes, it has kept me from medical 
appointments or from getting my medications; (2) Yes, it has kept me

[[Page 17677]]

from non-medical meetings, appointments, work, or from getting things 
that I need; and (3) No. The patient or resident would be given the 
option to select all responses that apply. We are proposing to use the 
transportation data element from the PRAPARE Tool, with permission from 
National Association of Community Health Centers (NACHC), after 
considering research on the importance of addressing transportation 
needs as a critical SDOH.\181\
---------------------------------------------------------------------------

    \181\ Health Research & Educational Trust. (2017, November). 
Social determinants of health series: Transportation and the role of 
hospitals. Chicago, IL. Available at www.aha.org/transportation.www.aha.org/transportation.
---------------------------------------------------------------------------

    The proposed data element is responsive to research on the 
importance of addressing transportation needs as a critical SDOH and 
would adopt the Transportation item from the PRAPARE tool.\182\ This 
data element comes from the national PRAPARE social determinants of 
health assessment protocol, developed and owned by NACHC, in 
partnership with the Association of Asian Pacific Community Health 
Organization, the Oregon Primary Care Association, and the Institute 
for Alternative Futures. Similarly the Transportation data element used 
in the AHC Screening Tool was adapted from the PRAPARE tool. The AHC 
screening tool was implemented by the Center for Medicare and Medicaid 
Innovation's AHC Model and developed by a panel of interdisciplinary 
experts that looked at evidence-based ways to measure SDOH, including 
transportation. While the transportation access data element in the AHC 
screening tool serves the same purposes as our proposed SPADE 
collection about transportation barriers, the AHC tool has binary yes 
or no response options that do not differentiate between challenges for 
medical versus non-medical appointments and activities. We believe that 
this is an important nuance for informing PAC discharge planning to a 
community setting, as transportation needs for non-medical activities 
may differ than for medical activities and should be taken into 
account.\183\ We believe that use of this data element will provide 
sufficient information about transportation barriers to medical and 
non-medical care for SNF residents and patients to facilitate 
appropriate discharge planning and care coordination across PAC 
settings. As such, we are proposing to adopt the Transportation data 
element from PRAPARE. More information about development of the PRAPARE 
tool is available on the website at https://protect2.fireeye.com/url?k=7cb6eb44-20e2f238-7cb6da7b-0cc47adc5fa2-1751cb986c8c2f8c&u=http://www.nachc.org/prapare.
---------------------------------------------------------------------------

    \182\ Health Research & Educational Trust. (2017, November). 
Social determinants of health series: Transportation and the role of 
hospitals. Chicago, IL. Available at www.aha.org/transportation.
    \183\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
---------------------------------------------------------------------------

    In addition, we received stakeholder feedback during the December 
13, 2018 SDOH listening session on the impact of transportation 
barriers on unmet care needs. While recognizing that there is no 
consensus in the field about whether providers should have 
responsibility for resolving patient transportation needs, discussion 
focused on the importance of assessing transportation barriers to 
facilitate connections with available community resources.
    Adding a Transportation data element to the collection of SPADE 
would be an important step to identifying and addressing SDOH that 
impact health outcomes and patient experience for Medicare 
beneficiaries. For more information on the Transportation data element, 
we refer readers to the document titled ``Proposed Specifications for 
SNF QRP Measures and Standardized Patient Assessment Data Elements,'' 
available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of transportation data 
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we 
are proposing to adopt the Transportation data element described above 
as SPADE with respect to the Social Determinants of Health category. If 
finalized as proposed, we would add the Transportation data element to 
the MDS.
(e) Social Isolation
    Distinct from loneliness, social isolation refers to an actual or 
perceived lack of contact with other people, such as living alone or 
residing in a remote area.184 185 Social isolation tends to 
increase with age, is a risk factor for physical and mental illness, 
and a predictor of mortality.186 187 188 Post-acute care 
providers are well-suited to design and implement programs to increase 
social engagement of patients and residents, while also taking into 
account individual needs and preferences. Adopting a data element to 
collect and analyze information about social isolation in SNFs and 
across PAC settings would facilitate the identification of residents 
and patients who are socially isolated and who may benefit from 
engagement efforts.
---------------------------------------------------------------------------

    \184\ Tomaka, J., Thompson, S., and Palacios, R. (2006). The 
Relation of Social Isolation, Loneliness, and Social Support to 
Disease Outcomes Among the Elderly. J of Aging and Health. 18(3): 
359-384.
    \185\ Social Connectedness and Engagement Technology for Long-
Term and Post-Acute Care: A Primer and Provider Selection Guide. 
(2019). Leading Age. Available at https://www.leadingage.org/white-papers/social-connectedness-and-engagement-technology-long-term-and-post-acute-care-primer-and#1.1
    \186\ Landeiro, F., Barrows, P., Nuttall Musson, E., Gray, A.M., 
and Leal, J. (2017). Reducing Social Loneliness in Older People: A 
Systematic Review Protocol. BMJ Open. 7(5): e013778.
    \187\ Ong, A.D., Uchino, B.N., and Wethington, E. (2016). 
Loneliness and Health in Older Adults: A Mini-Review and Synthesis. 
Gerontology. 62:443-449.
    \188\ Leigh-Hunt, N., Bagguley, D., Bash, K., Turner, V., 
Turnbull, S., Valtorta, N., and Caan, W. (2017). An overview of 
systematic reviews on the public health consequences of social 
isolation and loneliness. Public Health. 152:157-171.
---------------------------------------------------------------------------

    We are proposing to adopt as SPADE a single social isolation data 
element that is currently part of the AHC Screening Tool. The AHC item 
was selected from the Patient-Reported Outcomes Measurement Information 
System (PROMIS[supreg]) Item Bank on Emotional Distress and asks, ``How 
often do you feel lonely or isolated from those around you?'' The five 
response options are: (1) Never; (2) Rarely; (3) Sometimes; (4) Often; 
and (5) Always.\189\ The AHC Screening Tool was developed by a panel of 
interdisciplinary experts that looked at evidence-based ways to measure 
SDOH, including social isolation. More information about the AHC 
Screening Tool is available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
---------------------------------------------------------------------------

    \189\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
---------------------------------------------------------------------------

    In addition, we received stakeholder feedback during the December 
13, 2018 SDOH listening session on the value of receiving information 
on social isolation for purposes of care planning. Some stakeholders 
also recommended assessing social isolation as an SDOH as opposed to 
social support.
    The proposed Social Isolation data element is consistent with NASEM 
considerations about social isolation as a function of social 
relationships that impacts health outcomes and increases mortality 
risk, as well as the current work of a NASEM committee examining how 
social isolation and loneliness impact health outcomes in adults 50

[[Page 17678]]

years and older. We believe that adding a Social Isolation data element 
would be an important component of better understanding resident and 
patient complexity and the care goals of residents and patients, 
thereby facilitating care coordination and continuity in care planning 
across PAC settings. For more information on the Social Isolation data 
element, we refer readers to the document titled ``Proposed 
Specifications for SNF QRP Measures and Standardized Patient Assessment 
Data Elements,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of social isolation data 
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we 
are proposing to adopt the Social Isolation data element described 
above as SPADE with respect to the proposed Social Determinants of 
Health category. We are proposing to add the Social Isolation data 
element to the MDS.
    We are soliciting comment on these proposals.
8. Proposed Form, Manner, and Timing of Data Submission Under the SNF 
QRP
a. Background
    We refer readers to the regulatory text at Sec.  413.360(b) for 
information regarding the current policies for reporting SNF QRP data.
b. Update to the CMS System for Reporting Quality Measures and 
Standardized Patient Assessment Data and Associated Procedural 
Proposals
    SNFs are currently required to submit MDS data to CMS using the 
Quality Improvement and Evaluation System (QIES) Assessment and 
Submission Processing (ASAP) system. We will be migrating to a new 
internet Quality Improvement and Evaluation System (iQIES) that will 
enable real-time upgrades over the next few years, and we are proposing 
to designate that system as the data submission system for the SNF QRP 
once it becomes available, but no later than October 1, 2021.
    We are proposing to revise our regulatory text at Sec.  413.360(a) 
by replacing ``Certification and Survey Provider Enhanced Reports 
(CASPER)'' with ``CMS designated data submission''. We are proposing to 
revise our regulatory text at Sec.  413.360(d)(1) by replacing the 
reference to the ``Quality Improvement Evaluation System (QIES) 
Assessment Submission and Processing (ASAP)'' with ``CMS designated 
data submission'' and Sec.  413.360(d)(4) by replacing the reference to 
``QIES ASAP'' with ``CMS designated data submission system'' effective 
October 1, 2019. In addition we are proposing to notify the public of 
any future changes to the CMS designated system using subregulatory 
mechanisms, such as website postings, listserv messaging, and webinars.
    We invite public comments on this proposal.
c. Proposed Schedule for Reporting the Transfer of Health Information 
Quality Measures Beginning With the FY 2022 SNF QRP
    As discussed in section VI.A.4. of this proposed rule, we are 
proposing to adopt the Transfer of Health Information to Provider-Post-
Acute Care (PAC) and Transfer of Health Information to Patient-Post-
Acute Care (PAC) quality measures beginning with the FY 2022 SNF QRP. 
We also are proposing that SNFs would report the data on those measures 
using the MDS. SNFs would be required to collect data on both measures 
for residents beginning with October 1, 2020 discharges.
    We refer readers to the FY 2018 SNF PPS final rule (82 FR 36601 
through 36603) for the data collection and submission time frames that 
we finalized for the SNF QRP.
    We invite public comment on this proposal.
d. Proposed Schedule for Reporting Standardized Patient Assessment Data 
Elements
    As discussed in section VI.A.6. of this proposed rule, we are 
proposing to adopt SPADEs beginning with the FY 2022 SNF QRP. We are 
proposing that SNFs would report the data using the MDS. Similar to the 
proposed schedule for reporting the Transfer of Health Information to 
the Provider-Post-Acute Care (PAC) and Transfer of Health Information 
to the Patient-Post-Acute Care (PAC) quality measures, SNFs would be 
required to collect the SPADEs for residents beginning with October 1, 
2020 admissions and discharges. SNFs that submit data with respect to 
admission for the Hearing, Vision, Race, and Ethnicity SPADEs would be 
considered to have submitted data with respect to discharges. We refer 
readers to the FY 2018 SNF PPS final rule (82 FR 36601 through 36603) 
for the data collection and submission time frames that we finalized 
for the SNF QRP.
e. Proposed Data Reporting on Residents for the SNF Quality Reporting 
Program Beginning With the FY 2022 SNF QRP
    We have received public input suggesting that the quality measures 
used in the SNF QRP should be calculated using data collected from all 
residents receiving SNF services, regardless of the residents' payer. 
This input was provided to us via comments requested about quality 
measure development on the CMS Measures Management System Blueprint 
website,\190\ the TEPs held by our measure development contractor,\191\ 
as well as through comments we received from stakeholders via our SNF 
QRP mailbox, and feedback received from the NQF-convened Measure 
Applications Partnership (MAP) as part of their recommendations on 
Coordination Strategy for Post-Acute Care and Long-Term Care 
Performance Measurement.\192\ Further, in the FY 2018 SNF PPS proposed 
rule (82 FR 21077), we sought input on expanding the reporting of 
quality data to include all residents, regardless of payer, so as to 
ensure that the SNF QRP makes publicly available information regarding 
the quality of the services furnished to the SNF population as a whole, 
rather than just those residents who have Medicare.
---------------------------------------------------------------------------

    \190\ Public Comment Summary Report Posting for Transfer of 
Health Information and Care Preferences. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Development-of-Cross-Setting-Transfer-of-Health-Information-Quality-Meas.pdf.
    \191\ Technical Expert Panel Summary Report: Development and 
Maintenance of Quality Measures for Skilled Nursing Facility Quality 
Reporting Program. April 2018. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/TEP-Summary-Report_April-2018_Development-and-Maintenance-of-Quality-Measures-for-SNF-QRP.pdf.
    \192\ MAP Coordination Strategy for Post-Acute Care and Long-
Term Care Performance Measurement. Feb 2012. http://www.qualityforum.org/Publications/2012/02/MAP_Coordination_Strategy_for_Post-Acute_Care_and_Long-Term_Care_Performance_Measurement.aspx.
---------------------------------------------------------------------------

    In response to that request for public input, several commenters, 
including MedPAC, submitted comments stating that they would be 
supportive of an effort to collect data specified under the SNF QRP 
from all SNF residents regardless of their payer. Benefits highlighted 
by commenters included that such data would serve to better inform 
beneficiaries on the broader quality of the entire SNF, as well as more 
comprehensive quality improvement efforts across payers. MedPAC also 
highlighted that while the data collection activity incurs some

[[Page 17679]]

cost, some providers currently assess all residents routinely. For a 
more detailed discussion we refer readers to the FY 2018 final rule (82 
FR 36603 through 36604).
    Further, we believe that the most accurate representation of the 
quality provided in SNFs to Medicare residents would be best conveyed 
using data collected via the MDS on all SNF residents, regardless of 
payer.
    Accordingly, we are proposing that for purposes of meeting the 
requirements of the SNF QRP, SNF would be required to collect and 
submit MDS data on all SNF residents regardless of their payer. We 
believe that this proposal will ensure that Medicare residents are 
receiving the same quality of SNF care as other residents.
    While we appreciate that collecting quality data on all residents 
regardless of payer may create additional burden, we are aware that 
many SNFs currently collect MDS data on all residents, regardless of 
their payer, and that some SNFs may consider it burdensome to separate 
out Medicare beneficiaries from other residents for purposes of 
submitting the assessments to CMS.
    We also note that collecting data on all SNF residents, regardless 
of their payer, would align our data collection requirements under the 
SNF QRP with the data collection requirements we have adopted for the 
LTCH QRP and Hospice QRP.
    This proposal, if finalized, would be effective beginning with the 
FY 2022 program year.
    We invite public comment on this proposal.
9. Proposed Policies Regarding Public Display of Measure Data for the 
SNF QRP
    Section 1899B(g) of the Act requires the Secretary to establish 
procedures for making the SNF QRP data available to the public after 
ensuring that SNFs have the opportunity to review their data prior to 
public display. Measure data are currently displayed on the Nursing 
Home Compare website, an interactive web tool that assists individuals 
by providing information on SNF quality of care. For more information 
on Nursing Home Compare, we refer readers to the website at https://www.medicare.gov/nursinghomecompare/search.html. For a more detailed 
discussion about our policies regarding public display of SNF QRP 
measure data and procedures for the opportunity to review and correct 
data and information, we refer readers to the FY 2017 SNF PPS final 
rule (81 FR 52045 through 52048).
    In this proposed rule, we are proposing to begin publicly 
displaying data for the Drug Regimen Review Conducted With Follow-Up 
for Identified Issues--Post Acute Care (PAC) Skilled Nursing Facility 
(SNF) Quality Reporting Program (QRP) measure beginning CY 2020 or as 
soon as technically feasible. We finalized the Drug Regimen Review 
Conducted With Follow-Up for Identified Issues--Post Acute Care (PAC) 
Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) measure 
in the FY 2017 SNF PPS final rule (81 FR 52034 through 52039).
    Data collection for this assessment-based measure began with 
patients admitted and discharged on or after October 1, 2018. We are 
proposing to display data based on four rolling quarters, initially 
using discharges from January 1, 2019 through December 31, 2019 
(Quarter 1 2019 through Quarter 4 2019). To ensure the statistical 
reliability of the data, we are proposing that we would not publicly 
report a SNF's performance on the measure if the SNF had fewer than 20 
eligible cases in any four consecutive rolling quarters. SNFs that have 
fewer than 20 eligible cases would be distinguished with a footnote 
that states, ``The number of cases/resident stays is too small to 
publicly report''. We invite public comment on our proposal.

B. Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP)

1. Background
    Section 215(b) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93) authorized the SNF VBP Program (the 
``Program'') by adding section 1888(h) to the Act. As a prerequisite to 
implementing the SNF VBP Program, in the FY 2016 SNF PPS final rule (80 
FR 46409 through 46426), we adopted an all-cause, all-condition 
hospital readmission measure, as required by section 1888(g)(1) of the 
Act and discussed other policies to implement the Program such as 
performance standards, the performance period and baseline period, and 
scoring. In the FY 2017 SNF PPS final rule (81 FR 51986 through 52009), 
we adopted an all-condition, risk-adjusted potentially preventable 
hospital readmission measure for SNFs, as required by section 
1888(g)(2) of the Act, and adopted policies on performance standards, 
performance scoring, and sought comment on an exchange function 
methodology to translate SNF performance scores into value-based 
incentive payments, among other topics. In the FY 2018 SNF PPS final 
rule (82 FR 36608 through 36623), we adopted additional policies for 
the Program, including an exchange function methodology for disbursing 
value-based incentive payments. Additionally, in the FY 2019 SNF PPS 
final rule (83 FR 39272 through 39282), we adopted more policies for 
the Program, including a scoring adjustment for low-volume facilities.
    The SNF VBP Program applies to freestanding SNFs, SNFs affiliated 
with acute care facilities, and all non-CAH swing-bed rural hospitals. 
Section 1888(h)(1)(B) of the Act requires that the SNF VBP Program 
apply to payments for services furnished on or after October 1, 2018. 
We believe the implementation of the SNF VBP Program is an important 
step towards transforming how care is paid for, moving increasingly 
towards rewarding better value, outcomes, and innovations instead of 
merely rewarding volume.
    For additional background information on the SNF VBP Program, 
including an overview of the SNF VBP Report to Congress and a summary 
of the Program's statutory requirements, we refer readers to the FY 
2016 SNF PPS final rule (80 FR 46409 through 46410). We also refer 
readers to the FY 2017 SNF PPS final rule (81 FR 51986 through 52009) 
for discussion of the policies that we adopted related to the 
potentially preventable hospital readmission measure, scoring, and 
other topics. We refer readers to the FY 2018 SNF PPS final rule (82 FR 
36608 through 36623) for discussions of the policies that we adopted 
related to value-based incentive payments, the exchange function, and 
other topics. Finally, we refer readers to the FY 2019 SNF PPS final 
rule (83 FR 39272 through 39282), where we adopted a corrections policy 
for numerical values of performance standards, a scoring adjustment for 
low-volume facilities, and addressed other topics.
2. Measures
a. Background
    For background on the measures we have adopted for the SNF VBP 
Program, we refer readers to the FY 2016 SNF PPS final rule (80 FR 
46419), where we finalized the Skilled Nursing Facility 30-Day All-
Cause Readmission Measure (SNFRM) (NQF #2510) that we are currently 
using for the SNF VBP Program. We also refer readers to the FY 2017 SNF 
PPS final rule (81 FR 51987 through 51995), where we finalized the 
Skilled Nursing Facility 30-Day Potentially Preventable Readmission 
Measure (SNFPPR) that we will use for the SNF VBP Program instead of 
the

[[Page 17680]]

SNFRM as soon as practicable, as required by statute.
b. SNFPPR Update--Change of Measure Name
    In the FY 2017 SNF PPS final rule (81 FR 51987 to 51995), we 
adopted the SNFPPR as the SNF all-condition risk-adjusted potentially 
preventable hospital readmission measure for the SNF VBP Program to 
meet the requirements in section 1888(g)(2) of the Act. This claims-
based measure assesses the facility-level risk-standardized rate of 
unplanned, potentially preventable hospital readmissions for SNF 
patients within 30 days of discharge from a prior admission to an 
Inpatient Prospective Payment System (IPPS) hospital, CAH, or 
psychiatric hospital. However, we have not yet transitioned the SNF VBP 
Program to using the SNFPPR.
    The SNFPPR is one of two potentially preventable readmission 
measures specified for use in the SNF setting. The SNFPPR is specified 
for use for the SNF VBP Program and a second measure, the Potentially 
Preventable 30-Day Post-Discharge Readmission Measure for Skilled 
Nursing Facility Quality Reporting Program, is specified for use in the 
SNF QRP. While these two measures are aligned in terms of exclusion 
criteria and risk adjustment approach, they differ in their readmission 
windows. The SNFPPR utilizes a 30-day post-hospital discharge 
readmission window whereas the SNF QRP potentially preventable 
readmission measure utilizes a 30-day post-SNF discharge readmission 
window, consistent with the discharge readmission window specified in 
other measures we have developed with respect to domains described in 
section 1899B of the Act, such as the Potentially Preventable 30-Day 
Post-Discharge Readmission Measure for Inpatient Rehabilitation 
Facility QRP and the Potentially Preventable 30-Day Post-Discharge 
Readmission Measure for Home Health QRP.
    As described in the FY 2017 SNF PPS final rule (81 FR 51992), our 
rationale for having two different measures was that the readmission 
window associated with each measure assesses different aspects of SNF 
care. The readmission window for the SNFPPR measure was developed to 
align with the SNFRM which was previously adopted for the SNF VBP 
Program. Both the SNFRM and SNFPPR measure specifications, including 
the readmission window, were designed to harmonize with CMS's Hospital 
Wide All-Cause Unplanned Readmission (HWR) measure used in the Hospital 
IQR Program. The advantage of this window is that it assesses 
readmissions both during the SNF stay and post-SNF discharge for most 
SNF patients, depending on the SNF length of stay (LOS).
    The readmission window used for the SNF QRP measure aligns with the 
readmission window used in other readmission measures for post-acute 
care (PAC) providers. The focus of this post-PAC only discharge 
readmission window is on assessing potentially preventable hospital 
readmissions during the 30 days after discharge from the PAC provider.
    While the SNFPPR and the SNF QRP potentially preventable 
readmission measures assess different aspects of SNF care, we have 
received stakeholder feedback that having two SNF potentially 
preventable readmission measures has caused confusion. To minimize the 
confusion surrounding these two different measures, we are changing the 
name of the SNFPPR to Skilled Nursing Facility Potentially Preventable 
Readmissions after Hospital Discharge. We believe this new measure name 
will clearly differentiate the SNF VBP potentially preventable 
readmission measure from the SNF QRP potentially preventable 
readmission measure, thereby reducing stakeholder confusion. We intend 
to submit the SNFPPR measure, hereafter referred to as the Skilled 
Nursing Facility Potentially Preventable Readmissions after Hospital 
Discharge measure, to the National Quality Forum (NQF) for endorsement 
review as soon as that is feasible.
3. FY 2022 Performance Period and Baseline Period and for Subsequent 
Years
    We refer readers to the FY 2016 SNF PPS final rule (80 FR 46422) 
for a discussion of our considerations for determining performance 
periods under the SNF VBP Program. Based on those considerations, as 
well as public comment, we adopted CY 2017 as the performance period 
for the FY 2019 SNF VBP Program, with a corresponding baseline period 
of CY 2015.
    Additionally, in the FY 2018 SNF PPS final rule (82 FR 36613 
through 36614), we adopted FY 2018 as the performance period for the FY 
2020 SNF VBP Program, with a corresponding baseline period of FY 2016. 
We refer readers to that rule for a discussion of the need to shift the 
Program's measurement periods from the calendar year to the fiscal 
year. Finally, we refer readers to the FY 2019 SNF PPS final rule (83 
FR 39277 through 39278), where we adopted FY 2019 as the performance 
period for the FY 2021 program year, with a corresponding baseline 
period of FY 2017. In that final rule, we also adopted a policy where 
we would adopt for each program year a performance period that is the 
1-year period following the performance period for the previous program 
year. We adopted a similar policy for the baseline period, where we 
stated that we would adopt for each program year a baseline period that 
is the 1-year period following the baseline period for the previous 
year.
    Under this policy, the performance period for the FY 2022 program 
year will be FY 2020, and the baseline period will be FY 2018.
4. Performance Standards
a. Background
    We refer readers to the FY 2017 SNF PPS final rule (81 FR 51995 
through 51998) for a summary of the statutory provisions governing 
performance standards under the SNF VBP Program and our finalized 
performance standards policy, as well as the numerical values for the 
achievement threshold and benchmark for the FY 2019 program year. We 
also responded to public comments on these policies in that final rule.
    We published the final numerical values for the FY 2020 performance 
standards in the FY 2018 SNF PPS final rule (82 FR 36613) and published 
the final numerical values for the FY 2021 performance standards in the 
FY 2019 SNF PPS final rule (83 FR 39276). We also adopted a policy 
allowing us to correct the numerical values of the performance 
standards in the FY 2019 SNF PPS final rule (83 FR 39276 through 
39277).
b. FY 2022 Performance Standards
    As we discuss in this proposed rule, we will adopt FY 2018 as the 
baseline period for the FY 2022 program year under our previously-
adopted policy of advancing the performance and baseline period for 
each program year automatically.
    Based on the baseline period for the FY 2022 program year, we are 
estimating that the performance standards would have the numerical 
values noted in Table 14. We note that these values represent estimates 
based on the most recently-available data, and we will update the 
numerical values in the FY 2020 SNF PPS final rule.

[[Page 17681]]



                        Table 14--Estimated FY 2022 SNF VBP Program Performance Standards
----------------------------------------------------------------------------------------------------------------
                                                                                  Achievement
                  Measure ID                         Measure description           threshold        Benchmark
----------------------------------------------------------------------------------------------------------------
SNFRM........................................  SNF 30-Day All-Cause                    0.79476          0.83212
                                                Readmission Measure (NQF
                                                #2510).
----------------------------------------------------------------------------------------------------------------

5. SNF VBP Performance Scoring
    We refer readers to the FY 2017 SNF PPS final rule (81 FR 52000 
through 52005) for a detailed discussion of the scoring methodology 
that we have finalized for the Program, along with responses to public 
comments on our policies and examples of scoring calculations. We also 
refer readers to the FY 2018 SNF PPS final rule (82 FR 36614 through 
36616) for discussion of the rounding policy we adopted, our request 
for comments on SNFs with zero readmissions, and our request for 
comments on a potential extraordinary circumstances exception policy.
    We also refer readers to the FY 2019 SNF PPS final rule (83 FR 
39278 through 39281), where we adopted (1) A scoring policy for SNFs 
without sufficient baseline period data, (2) a scoring adjustment for 
low-volume SNFs, and (3) an extraordinary circumstances exception 
policy.
    We are not proposing any updates to SNF VBP scoring policies in 
this proposed rule.
6. SNF Value-Based Incentive Payments
    We refer readers to the FY 2018 SNF PPS final rule (82 FR 36616 
through 36621) for discussion of the exchange function methodology that 
we have adopted for the Program, as well as the specific form of the 
exchange function (logistic, or S-shaped curve) that we finalized, and 
the payback percentage of 60 percent. We adopted these policies for FY 
2019 and subsequent fiscal years.
    We also discussed the process that we undertake for reducing SNFs' 
adjusted Federal per diem rates under the Medicare SNF PPS and awarding 
value-based incentive payments in the FY 2019 SNF PPS final rule (83 FR 
39281 through 39282).
    For estimates of FY 2020 SNF VBP Program incentive payment 
multipliers, we encourage SNFs to refer to FY 2019 SNF VBP Program 
performance information, available at: https://data.medicare.gov/Nursing-Home-Compare/SNF-VBP-Facility-Level-Dataset/284v-j9fz. Our 
analysis of historical SNF VBP data shows that the Program's incentive 
payment multipliers appear to be relatively consistent over time. As a 
result, we believe that the FY 2019 payment results represent our best 
estimate of FY 2020 performance at this time.
    We are not proposing any updates to SNF VBP payment policies in 
this proposed rule. However, for the reader's information, we modeled 
the estimated impacts of the low-volume adjustment policy that we 
established in the FY 2019 SNF PPS final rule for FY 2020 and estimate 
that the application of the low-volume adjustment policy to the FY 2020 
program year would redistribute an additional $8.1 million to these 
low-volume SNFs for that program year. This would increase the 60 
percent payback percentage for FY 2020 by approximately 1.51 percent, 
resulting in a payback percentage for FY 2020 that is 61.51 percent of 
the estimated $534.1 million in withheld funds for that fiscal year.
7. Public Reporting on the Nursing Home Compare Website
a. Background
    Section 1888(g)(6) of the Act requires the Secretary to establish 
procedures to make SNFs' performance information on SNF VBP Program 
measures available to the public on the Nursing Home Compare website or 
a successor, and to provide SNFs an opportunity to review and submit 
corrections to that information prior to its publication. We began 
publishing SNFs' performance information on the SNFRM in accordance 
with this directive and the statutory deadline of October 1, 2017.
    Additionally, section 1888(h)(9)(A) of the Act requires the 
Secretary to make available to the public certain information on SNFs' 
performance under the SNF VBP Program, including SNF Performance Scores 
and their ranking. Section 1888(h)(9)(B) of the Act requires the 
Secretary to post aggregate information on the Program, including the 
range of SNF Performance Scores and the number of SNFs receiving value-
based incentive payments, and the range and total amount of those 
payments.
    In the FY 2017 SNF PPS final rule (81 FR 52009), we discussed the 
statutory requirements governing public reporting of SNFs' performance 
information under the SNF VBP Program. We also sought and responded to 
public comments on issues that we should consider when posting 
performance information on Nursing Home Compare or a successor website. 
In the FY 2018 SNF PPS final rule (82 FR 36622 through 36623), we 
finalized our policy to publish SNF measure performance information 
under the SNF VBP Program on Nursing Home Compare after SNFs have had 
an opportunity to review and submit corrections to that information 
under the two-phase Review and Corrections process that we adopted in 
the FY 2017 SNF PPS final rule (81 FR 52007 through 52009) and for 
which we adopted additional requirements in the FY 2018 SNF PPS final 
rule. In the FY 2018 SNF PPS final rule, we also adopted requirements 
to rank SNFs and adopted data elements that we will include in the 
ranking to provide consumers and stakeholders with the necessary 
information to evaluate SNFs' performance under the Program.
b. Public Reporting of SNF Performance Scores, Achievement and 
Improvement Scores, and Ranking
    As we have considered issues associated with public reporting of 
SNFs' performance information on the Nursing Home Compare website, we 
have identified an issue that we believe warrants additional 
discussion. Specifically, we are concerned that the performance 
information available for display for a specific SNF may, as a result 
of the application of two policies we have finalized for the Program, 
be confusing to the public. Specifically, SNFs with fewer than 25 
eligible stays during the baseline period for a fiscal year will only 
be scored on achievement and will not have improvement information 
available for display. In addition, a SNF with fewer than 25 eligible 
stays during a performance period will receive an assigned SNF 
performance score for that Program year that results in a value-based 
incentive payment amount equal to the adjusted federal per diem rate 
that the SNF would have received for the fiscal year in the absence of 
the Program.
    In these cases, we do not believe it would be appropriate to 
suppress the SNF's information entirely given the statutory 
requirements in section 1888(h)(9)(A) of the Act to publicly report 
SNF-specific information, but we are concerned about publishing 
performance information that is not

[[Page 17682]]

based on enough data to convey a complete and reliable picture of a 
SNF's performance for the Program year.
    Based on these considerations, we propose to suppress the SNF 
information available to display as follows: (1) If a SNF has fewer 
than 25 eligible stays during the baseline period for a Program year, 
we would not display the baseline RSRR or improvement score, though we 
would still display the performance period RSRR, achievement score and 
total performance score if the SNF had sufficient data during the 
performance period; (2) if a SNF has fewer than 25 eligible stays 
during the performance period for a Program year and receives an 
assigned SNF performance score as a result, we would report the 
assigned SNF performance score and we would not display the performance 
period RSRR, the achievement score or improvement score; and (3) if a 
SNF has zero eligible cases during the performance period for a Program 
year, we would not display any information for that SNF. Based on 
historical data, we estimate that approximately 16 percent of SNFs will 
have fewer than 25 eligible stays during the performance period and 
similarly approximately 16 percent of SNFs will have fewer than 25 
stays in the baseline period for FY 2020.
    We believe that this policy will ensure that we publish as much 
information as possible about the SNF VBP Program's performance 
assessments while ensuring that the published information is reliable 
and based on a sufficient quantity of information. We further believe 
that this policy will provide stakeholders with meaningful information 
about SNFs' performance under the Program.
    We welcome public comment on this proposal.
8. Update to Phase One Review and Correction Deadline
    In the FY 2017 SNF PPS final rule (81 FR 52007 through 52009), we 
adopted a two-phase review and corrections process for SNFs' quality 
measure data that will be made public under section 1888(g)(6) of the 
Act and SNF performance information that will be made public under 
section 1888(h)(9) of the Act. We explained that we would accept 
corrections to the quality measure data used to calculate the measure 
rates that are included in any SNF's quarterly confidential feedback 
report, and that we would provide SNFs with an annual confidential 
feedback report containing the performance information that will be 
made public. We detailed the process for requesting Phase One 
corrections and finalized a policy whereby we would accept Phase One 
corrections to any quarterly report provided during a calendar year 
until the following March 31.
    However, as we have continued implementation of the SNF VBP 
Program, we have reconsidered what deadline would be appropriate for 
the Phase One correction process. Our experience managing the 2019 SNF 
VBP Program has shown that fewer than 10 facilities submitted 
sufficient correction information under the Phase One correction 
process after October 1, 2018 and before March 31, 2019. Additionally, 
we are concerned about the effects of the March 31 deadline on value-
based incentive payment calculations since the deadline is currently 6 
months after payment incentives begin. For example, performance score 
reports for the FY 2019 SNF VBP Program were provided in August 2018 
and incentive payments for that FY were made beginning with services 
provided on October 1, 2018, but SNFs still had until March 31, 2019 to 
make a correction. We believe that the March 31 deadline also creates 
uncertainty for SNFs because, as shown above in the timeline that 
applied to the FY 2019 Program, their payment incentives could 
potentially change 6 months after they take effect. If we approve a 
correction request, we then need to reprocess several months of claims 
for the SNF in question and potentially need to adjust the exchange 
function for the fiscal year depending on the scope of the correction 
and its effects on the payback percentage pool for the fiscal year. We 
do not believe these outcomes are beneficial to the Program or to SNFs 
that would have less predictability about their incentive payment 
percentages for the fiscal year. We believe that the lack of 
predictability for SNF payment percentages might adversely impact SNF 
financial planning because payment amounts would not be set for all 
SNFs until after the March 31 deadline.
    We believe that we can mitigate this uncertainty by adopting a 30-
day deadline for Phase One correction requests, and note that this 
proposal would align the Phase One review and correction process with 
the Phase Two process. Under current operations, we issue a report in 
June that contains all of the underlying claim information used to 
calculate the measure rate for the program year, as well as the measure 
rate itself. We are proposing that SNFs would have 30 days from the 
date that we issue that report to review the claims and measure rate 
information and to submit to us a correction request if the SNF 
believes that any of that information is inaccurate. We note that this 
proposal would not preclude a SNF from submitting a correction request 
for any claims for which it discovers an error prior to receiving the 
June report. However, the 30 day review and correction period would 
commence on the day that we issue the June report, and a SNF would not 
be able to request that we correct any underlying claims or its measure 
rate after the conclusion of that 30 day period.
    We are proposing this deadline in lieu of the current March 31 
deadline for Phase One corrections. We note that we initially proposed 
to adopt a 30-day deadline for Phase One corrections in the FY 2017 SNF 
PPS proposed rule (81 FR 24255), though we finalized a deadline of 
March 31 following the calendar year in which we provide the report. We 
adopted that extended deadline to balance our desire to ensure that 
measure data are sufficiently accurate with SNFs' need for sufficient 
information with which to evaluate those reports, as well as to provide 
SNFs with more time to review each quarter's data. In addition, we 
encouraged SNFs to review the quarterly reports provided with stay-
level information and make any corrections to claims before the 
proposed deadline. However, for the reasons discussed above, we now 
believe that a 30-day timeframe is sufficient for SNFs to determine if 
there were errors in its measure calculation by CMS or its contractor.
    We believe that this policy will ensure that the underlying claims 
data that we use to calculate quality measure performance for the SNF 
VBP Program will be finalized prior to their use in scoring and payment 
calculations. We believe that this policy will also ensure that any 
corrections submitted under Phase One do not result in changes to 
quality measure data months after incentive payment calculations, which 
will also avoid changes to the exchange function, and as a result, 
changes to other SNFs' value-based incentive payment percentages for a 
fiscal year because of data errors for any SNFs. Our experience 
managing the 2019 SNF VBP Program indicates that very few SNFs would be 
adversely impacted by the earlier deadline. We also seek to provide 
SNFs with earlier final annual payment percentage information for their 
financial planning purposes.
    We welcome public comments on this proposal.

VII. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et 
seq.), we are required to publish a 60-day

[[Page 17683]]

notice in the Federal Register and solicit public comment before a 
``collection of information'' requirement is submitted to the Office of 
Management and Budget (OMB) for review and approval. For the purposes 
of the PRA and this section of the preamble, collection of information 
is defined under 5 CFR 1320.3(c) of the PRA's implementing regulations.
    To fairly evaluate whether an information collection should be 
approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit 
comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be 
collected.
     Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    We are soliciting public comment on each of the section 
3506(c)(2)(A)-required issues for the following information collection 
requirements (ICRs).

A. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2017 National Occupational Employment and Wage 
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 15 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
the mean hourly wage), and the adjusted hourly wage. The adjusted wage 
is used to derive this section's average cost estimates.

                          Table 15--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    benefits and      Adjusted
                Occupation title                       code         wage ($/hr)    overhead ($/   hourly wage ($/
                                                                                        hr)             hr)
----------------------------------------------------------------------------------------------------------------
Health Information Technician...................         29-2071           20.59           20.59           41.18
Registered Nurse................................         29-1141           35.36           35.36           70.72
----------------------------------------------------------------------------------------------------------------

    As indicated, we are adjusting our employee hourly wage estimates 
by a factor of 100 percent. This is necessarily a rough adjustment, 
both because fringe benefits and overhead costs vary significantly from 
employer to employer, and because methods of estimating these costs 
vary widely from study to study. Nonetheless, we believe that doubling 
the mean hourly wage to help estimate the total cost is a reasonably 
accurate estimation method.

B. Proposed Information Collection Requirements (ICRs)

1. ICRs Regarding the SNF Quality Reporting Program (QRP)
    The following proposed changes will be submitted to OMB for 
approval under control number 0938-1140 (CMS-10387). The changes would 
not impose any new or revised burden. Subject to renewal, the control 
number is currently set to expire on February 28, 2022. It was last 
approved on February 12, 2019, and remains active.
    The Minimum Data Set (MDS) is part of the process for the clinical 
assessment of all SNF residents and serves multiple purposes. It is 
used as a data collection tool for SNFs in the PPS to inform the 
Patient Driven Payment Model (PDPM) for the purpose of reimbursement, 
for the SNF QRP for the purpose of monitoring the quality of care in 
SNFs, and under the requirements of Omnibus Budget Reconciliation Act 
(OBRA) 1987 for the collection of data for the purposes of 
comprehensive resident assessment, quality and care planning for SNF 
residents.
    Under sections 4204(b) and 4214(d) of OBRA 1987, requirements 
related to the submission and retention of resident assessment data are 
not subject to the PRA. The MDS assessments that are used to inform 
payment consist of the PPS 5-day assessment, the PPS discharge 
assessment, and the optional Interim Payment Assessment (IPA). The 
requirements necessary to administer the payment rate methodology 
described in 42 CFR 413.337 are subject to the PRA. Thus, the PPS 5-
day, PPS discharge, and IPA assessments are subject to the PRA and are 
active under OMB control number 0938-1140.\193\ For the readers' 
convenience, the active burden estimates are summarized below in Table 
16. It is important to note that SNFs currently collect and report data 
for the SNF QRP through the PPS 5-day and PPS discharge assessments, 
which are the same assessments used in the PDPM. The IPA is an optional 
assessment for the PDPM and is not used for the SNF QRP.
---------------------------------------------------------------------------

    \193\ Available at https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201809-0938-009.
---------------------------------------------------------------------------

    Section 2(a) of the IMPACT Act amended the statute by adding 
section 1899B to the Act, which requires, among other things, SNFs to 
report standardized patient assessment data, data on quality measures, 
and data on resource use and other measures. Under section 1899B(m) of 
the Act, modifications to the SNF assessment instrument, the MDS, 
required to achieve standardization of patient assessment data are 
exempt from PRA requirements. However, if the data elements for quality 
measures and standardized patient assessment data are finalized as 
proposed, then we believe that we will have met the requirements for 
standardization of patient assessment data. Therefore, the exemption of 
the SNF QRP from the PRA is no longer applicable such that the SNF QRP 
requirements and burden will be submitted to OMB for review and 
approval. The active ICR serves as the basis for which we now address 
the previously exempt requirements and burden.
    Under our active information collection, only the PPS 5-day and PPS 
discharge assessments used in the PDPM are also used as the assessments 
for collecting quality measure and standardized patient assessment data 
under the SNF QRP. Our active burden sets out 51 minutes (0.85 hours) 
per PPS 5-day assessment and 51 minutes per PPS discharge assessment. 
Consistent with the FY 2019 SNF PPS final rule (August 8, 2018; 83 FR 
39283) we continue to use the OMRA assessment (with 272 items) to 
estimate the amount of time to complete a PPS assessment. This is also 
consistent with our active information collection. In sections VI.A.4 
and VI.A.7 of this rule, we propose to add 60.5 items across the PPS 5-
day and PPS discharge assessments. Given that the PPS OMRA item set has 
272 items (as compared to the PPS discharge assessment with 143 items) 
that are approved under our active collection, the added items, while 
increasing burden for each of the assessments, have no impact on our 
currently approved burden estimates since the active collection uses 
the PPS

[[Page 17684]]

OMRA item set as a proxy for all assessments. Below, however, we are 
restating such burden as a courtesy to interested parties.
    When calculating the burden for each assessment, we estimate it 
will take 40 minutes (0.6667 hours) at $70.72/hr for an RN to collect 
the information necessary for preparing the assessment, 10 minutes 
(0.1667 hours) at $55.95/hr (the average hourly wage for RN ($70.72/hr) 
and health information technician ($41.18/hr)) for staff to code the 
responses, and 1 minute (0.0167 hours) at $41.18/hr for a health 
information technician to transmit the results. In total, we estimate 
that it will take 51 minutes (0.85 hours) to complete a single PPS 
assessment. Based on the adjusted hourly wages for the noted staff, we 
estimate that it will cost $57.17 [($70.72/hr x 0.6667 hr) + ($55.95/hr 
x 0.1667 hr) + ($41.18/hr x 0.0167 hr)] to prepare, code, and transmit 
each PPS assessment.
    Based on our most current data, there are 15,471 Medicare Part A 
SNFs. Based on FY 2017 data, we estimate that 2,406,401 5-day PPS 
assessments will be completed and submitted by Part A SNFs each year 
under the PDPM and SNF QRP. We used the same number of assessments 
(2,406,401) as a proxy for the number of PPS discharge assessments that 
would be completed and submitted each year, since all residents who 
require a 5-day PPS assessment will also require a discharge assessment 
under the PDPM and SNF QRP. We use the Significant Change in Status 
Assessment (SCSA) as a proxy to estimate the number of IPAs as the 
criteria for completing an SCSA is similar to that for the IPA. Based 
on FY 2017 data, 92,240 IPAs would be completed per year under the 
PDPM.
    The total number of PPS 5-day assessments, PPS discharge 
assessments, and IPAs that would be completed across all facilities is 
4,905,042 assessments (2,406,401 + 2,406,401 + 92,240, respectively). 
The total estimated time for all assessments across all facilities is 
4,169,286 hours per year (4,905,042 assessments x 0.85 hours/
assessment). For all assessments across all facilities, we estimate a 
burden of $280,421,251 (4,905,042 assessments x $57.17/assessment).
    Given that our proposal to add 60.5 items across the PPS 5-day and 
PPS discharge assessments is accounted for by using the OMRA assessment 
as a proxy for all assessments, and given that our estimate for the 
number of Medicare Part A SNFs and for the number PPS 5-day and PPS 
discharge assessments completed and submitted by Part A SNFs each year 
remains unchanged, we are not proposing to revise or adjust any of our 
active burden estimates. In this regard, we will be submitting a 
revised information collection request to OMB to account for the added 
items.
    In section VI.A.8.b. of this proposed rule, there are no burden 
implications associated with updating the data submission system to the 
iQIES for the SNF QRP once it becomes available, but no later than 
October 1, 2021. This designation is a replacement of the existing QIES 
ASAP data submission system and imposes no additional requirements or 
burden on the part of SNFs.
2. ICRs Regarding the SNF VBP Program
    We are not proposing to remove, add, or revise any of our SNF VBP 
measure-related requirements or burden. Because this proposed rule 
would not impose any new or revised SNF VBP collection of information 
requirements or burden, the rule contains no SNF-VBP related 
collections of information that would be subject to OMB approval under 
the authority of the PRA.

C. Summary of Proposed Requirements and Annual Burden Estimates

                        Table 16--Summary of Proposed Requirements and Annual Burden Estimates Under OMB Control Number 0938-1140
                                                                       [CMS-10387]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Number      Responses (per       Total         Time per       Total time     Labor cost per hour
          Program changes             respondents     respondent)      responses     response (hr)       (hr)              ($/hr)         Total cost ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active Burden.....................          15,471          317.04       4,905,042            0.85       4,169,286  varies..............     280,421,251
Proposed Changes..................               0               0               0               0               0  0...................               0
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................          15,471          317.04       4,905,042            0.85       4,169,286  varies..............     280,421,251
--------------------------------------------------------------------------------------------------------------------------------------------------------

D. Submission of PRA-Related Comments

    We have submitted a copy of this proposed rule to OMB for its 
review of the rule's information collection and recordkeeping 
requirements. The requirements are not effective until they have been 
approved by OMB.
    We invite public comments on our proposed information collection 
requirements/burden. If you wish to comment, please identify the rule 
(CMS-1718-P) along with the information collection's CMS ID number 
(CMS-10387) and OMB control number (0938-1140).
    To obtain copies of the supporting statement and any applicable 
supplementary materials, you may make your request using one of 
following:
    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Email your request, including your address, phone number, OMB 
control number, and CMS document identifier to [email protected].
    3. Call the Reports Clearance Office at 410-786-1326.
    See this rule's DATES and ADDRESSES sections for the comment due 
date and for additional instructions.

VIII. 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.

IX. Economic Analyses

A. Regulatory Impact Analysis

1. Statement of Need
    This proposed rule would update the FY 2019 SNF prospective payment 
rates as required under section 1888(e)(4)(E) of the Act. It also 
responds to section 1888(e)(4)(H) of the Act, which requires the 
Secretary to provide for publication

[[Page 17685]]

in the Federal Register before the August 1 that precedes the start of 
each FY, the unadjusted federal per diem rates, the case-mix 
classification system, and the factors to be applied in making the area 
wage adjustment. As these statutory provisions prescribe a detailed 
methodology for calculating and disseminating payment rates under the 
SNF PPS, we do not have the discretion to adopt an alternative approach 
on these issues.
2. Introduction
    We have examined the impacts of this proposed rule 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 Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA, March 
22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 
4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    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. This rule has been designated an economically significant 
rule, under section 3(f)(1) of Executive Order 12866. Accordingly, we 
have prepared a regulatory impact analysis (RIA) as further discussed 
below. Also, the rule has been reviewed by OMB.
3. Overall Impacts
    This proposed rule sets forth updates of the SNF PPS rates 
contained in the SNF PPS final rule for FY 2019 (83 FR 39162). We 
estimate that the aggregate impact will be an increase of approximately 
$887 million in payments to SNFs in FY 2020, resulting from the SNF 
market basket update to the payment rates. We note that these impact 
numbers do not incorporate the SNF VBP reductions that we estimate will 
total $527.4 million in FY 2020. We would note that events may occur to 
limit the scope or accuracy of our impact analysis, as this analysis is 
future-oriented, and thus, very susceptible to forecasting errors due 
to events that may occur within the assessed impact time period.
    In accordance with sections 1888(e)(4)(E) and 1888(e)(5) of the 
Act, we update the FY 2019 payment rates by a factor equal to the 
market basket index percentage change adjusted by the MFP adjustment to 
determine the payment rates for FY 2020. The impact to Medicare is 
included in the total column of Table 17. In updating the SNF PPS rates 
for FY 2020, we made a number of standard annual revisions and 
clarifications mentioned elsewhere in this proposed rule (for example, 
the update to the wage and market basket indexes used for adjusting the 
federal rates).
    The annual update set forth in this proposed rule applies to SNF 
PPS payments in FY 2020. Accordingly, the analysis of the impact of the 
annual update that follows only describes the impact of this single 
year. Furthermore, in accordance with the requirements of the Act, we 
will publish a rule or notice for each subsequent FY that will provide 
for an update to the payment rates and include an associated impact 
analysis.
4. Detailed Economic Analysis
    The FY 2020 SNF PPS payment impacts appear in Table 17. Using the 
most recently available data, in this case FY 2018, we apply the 
current FY 2019 wage index and labor-related share value to the number 
of payment days to simulate FY 2019 payments. Then, using the same FY 
2018 data, we apply the proposed FY 2020 wage index and labor-related 
share value to simulate FY 2020 payments. We tabulate the resulting 
payments according to the classifications in Table 17 (for example, 
facility type, geographic region, facility ownership), and compare the 
simulated FY 2019 payments to the simulated FY 2020 payments to 
determine the overall impact. The breakdown of the various categories 
of data Table 17 follows:
     The first column shows the breakdown of all SNFs by urban 
or rural status, hospital-based or freestanding status, census region, 
and ownership.
     The first row of figures describes the estimated effects 
of the various changes on all facilities. The next six rows show the 
effects on facilities split by hospital-based, freestanding, urban, and 
rural categories. The next nineteen rows show the effects on facilities 
by urban versus rural status by census region. The last three rows show 
the effects on facilities by ownership (that is, government, profit, 
and non-profit status).
     The second column shows the number of facilities in the 
impact database.
     The third column shows the effect of the transition to 
PDPM. This represents the effect on providers, assuming no changes in 
behavior or case-mix, from changing the case-mix classification model 
used to classify patients in a Medicare Part A SNF stay. The total 
impact of this change is 0.0 percent; however, there are distributional 
effects of this change.
     The fourth column shows the effect of the annual update to 
the wage index. This represents the effect of using the most recent 
wage data available. The total impact of this change is 0.0 percent; 
however, there are distributional effects of the change.
     The fifth column shows the effect of all of the changes on 
the FY 2020 payments. The update of 2.5 percent is constant for all 
providers and, though not shown individually, is included in the total 
column. It is projected that aggregate payments will increase by 2.5 
percent, assuming facilities do not change their care delivery and 
billing practices in response.
    As illustrated in Table 17, the combined effects of all of the 
changes vary by specific types of providers and by location. For 
example, due to changes in this proposed rule, providers in the urban 
Pacific region would experience a 1.7 percent increase in FY 2020 total 
payments.
 BILLING CODE 4120-01-P

[[Page 17686]]

[GRAPHIC] [TIFF OMITTED] TP25AP19.006

5. Estimated Impacts for the Skilled Nursing Facility (SNF) Quality 
Reporting Program (QRP)
    Estimated impacts for the SNF QRP are based on analysis discussed 
in section VII.B.1. of this proposed rule. The proposed SNF QRP 
requirements add no additional burden to the active OMB #0938-1140 
(CMS-10387).
6. Impacts for the SNF VBP Program
    Estimated impacts of the FY 2020 SNF VBP Program are based on 
historical data and appear in Table 18. We modeled SNF performance in 
the Program using SNFRM data from CY 2015 as the baseline period and CY 
2017 as the performance period. Additionally, we modeled a logistic 
exchange function with a payback percentage of 60 percent, as we 
finalized in the FY 2018 SNF PPS final rule (82 FR 36619 through 
36621), though we note that the 60 percent payback percentage for FY 
2020 will adjust to account for the low-volume scoring adjustment that 
we adopted in the FY 2019 SNF PPS final rule (83 FR 39278 through 
39280). Based on the 60 percent payback percentage (as modified by the 
low-income scoring adjustment), we estimate that we will redistribute 
approximately $320.4 million in value-based incentive payments to SNFs 
in FY 2020, which means that the SNF VBP Program is estimated to result 
in approximately $213.6 million in savings to the Medicare Program in 
FY 2020. We refer readers to the FY 2019 SNF PPS final rule (83 FR 
39278 through 39280) for additional information about payment 
adjustments for low-volume SNFs in the SNF VBP Program.
    Our detailed analysis of the impacts of the FY 2020 SNF VBP Program 
follows in Table 18.

[[Page 17687]]

[GRAPHIC] [TIFF OMITTED] TP25AP19.007

 BILLING CODE 4120-01-C
7. Alternatives Considered
    As described in this section, we estimated that the aggregate 
impact for FY 2020 under the SNF PPS will be an increase of 
approximately $887 million in payments to SNFs, resulting from the SNF 
market basket update to the payment rates.
    Section 1888(e) of the Act establishes the SNF PPS for the payment 
of Medicare SNF services for cost reporting periods beginning on or 
after July 1, 1998. This section of the statute prescribes a detailed 
formula for calculating base payment rates under the SNF PPS, and does 
not provide for the use of any alternative methodology. It specifies 
that the base year cost data to be used for computing the SNF PPS 
payment rates must be from FY 1995 (October 1, 1994, through September 
30, 1995). In accordance with the statute, we also incorporated a 
number of elements into the SNF PPS (for example, case-mix 
classification methodology, a market basket index, a wage index, and 
the urban and rural distinction used in the development or adjustment 
of the federal rates). Further, section 1888(e)(4)(H) of the Act 
specifically requires us to disseminate the payment rates for each new 
FY through the Federal Register, and to do so before the August 1 that 
precedes the start of the new FY; accordingly, we are not pursuing 
alternatives for this process.
8. Accounting Statement
    As required by OMB Circular A-4 (available online at https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/), in Tables 19 and 
20, we have prepared an accounting statement showing the classification 
of the expenditures associated with the provisions of this proposed 
rule for FY 2020. Tables 17 and 19 provide our best estimate of the 
possible changes in Medicare payments under the SNF PPS

[[Page 17688]]

as a result of the policies in this proposed rule, based on the data 
for 15,078 SNFs in our database. Tables 18 and 20 provide our best 
estimate of the possible changes in Medicare payments under the SNF VBP 
as a result of the policies in this proposed rule.

 Table 19--Accounting Statement: Classification of Estimated Expenditures, From the 2019 SNF PPS Fiscal Year to
                                          the 2020 SNF PPS Fiscal Year
----------------------------------------------------------------------------------------------------------------
              Category                                                 Transfers
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Transfers......  $887 million.*
From Whom To Whom?..................  Federal Government to SNF Medicare Providers.
----------------------------------------------------------------------------------------------------------------
* The net increase of $887 million in transfer payments is a result of the market basket increase of $887
  million.


    Table 20--Accounting Statement: Classification of Estimated Expenditures for the FY 2020 SNF VBP Program
----------------------------------------------------------------------------------------------------------------
              Category                                                 Transfers
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Transfers......  $320.4 million.*
From Whom To Whom?..................  Federal Government to SNF Medicare Providers.
----------------------------------------------------------------------------------------------------------------
* This estimate does not include the two percent reduction to SNFs' Medicare payments (estimated to be $527.4
  million) required by statute.

9. Conclusion
    This proposed rule sets forth updates of the SNF PPS rates 
contained in the SNF PPS final rule for FY 2019 (83 FR 39162). Based on 
the above, we estimate that the overall payments for SNFs under the SNF 
PPS in FY 2020 are projected to increase by approximately $887 million, 
or 2.5 percent, compared with those in FY 2019. We estimate that in FY 
2020 under PDPM, SNFs in urban and rural areas will experience, on 
average, a 1.8 percent increase and 6.4 percent increase, respectively, 
in estimated payments compared with FY 2019. Providers in the urban 
Outlying region will experience the largest estimated increase in 
payments of approximately 61.3 percent. Providers in the urban Middle 
Atlantic region will experience the largest estimated decrease in 
payments of 0.8 percent.

B. Regulatory Flexibility Act Analysis

    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, non-profit organizations, and small 
governmental jurisdictions. Most SNFs and most other providers and 
suppliers are small entities, either by reason of their non-profit 
status or by having revenues of $27.5 million or less in any 1 year. We 
utilized the revenues of individual SNF providers (from recent Medicare 
Cost Reports) to classify a small business, and not the revenue of a 
larger firm with which they may be affiliated. As a result, for the 
purposes of the RFA, we estimate that almost all SNFs are small 
entities as that term is used in the RFA, according to the Small 
Business Administration's latest size standards (NAICS 623110), with 
total revenues of $27.5 million or less in any 1 year. (For details, 
see the Small Business Administration's website at http://www.sba.gov/category/navigation-structure/contracting/contracting-officials/eligibility-size-standards). In addition, approximately 20 percent of 
SNFs classified as small entities are non-profit organizations. 
Finally, individuals and states are not included in the definition of a 
small entity.
    This proposed rule sets forth updates of the SNF PPS rates 
contained in the SNF PPS final rule for FY 2019 (83 FR 39162). Based on 
the above, we estimate that the aggregate impact for FY 2020 will be an 
increase of $887 million in payments to SNFs, resulting from the SNF 
market basket update to the payment rates. While it is projected in 
Table 18 that most providers would experience a net increase in 
payments, we note that some individual providers within the same region 
or group may experience different impacts on payments than others due 
to the distributional impact of the FY 2020 wage indexes, PDPM 
transition and the degree of Medicare utilization.
    Guidance issued by the Department of Health and Human Services on 
the proper assessment of the impact on small entities in rulemakings, 
utilizes a cost or revenue impact of 3 to 5 percent as a significance 
threshold under the RFA. In their March 2019 Report to Congress 
(available at http://medpac.gov/docs/default-source/reports/mar19_medpac_ch8_sec.pdf), MedPAC states that Medicare covers 
approximately 11 percent of total patient days in freestanding 
facilities and 19 percent of facility revenue (March 2019 MedPAC Report 
to Congress, 197). As a result, for most facilities, when all payers 
are included in the revenue stream, the overall impact on total 
revenues should be substantially less than those impacts presented in 
Table 18. As indicated in Table 18, the effect on facilities is 
projected to be an aggregate positive impact of 2.5 percent for FY 
2020. As the overall impact on the industry as a whole, and thus on 
small entities specifically, is less than the 3 to 5 percent threshold 
discussed previously, the Secretary has determined that this proposed 
rule will not have a significant impact on a substantial number of 
small entities for FY 2020.
    In addition, section 1102(b) of 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 603 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 an MSA and has fewer 
than 100 beds. This proposed rule will affect small rural hospitals 
that (1) furnish SNF services under a swing-bed agreement or (2) have a 
hospital-based SNF. We anticipate that the impact on small rural 
hospitals will be a positive impact. Moreover, as noted in previous SNF 
PPS final rules (most recently, the one for FY 2019 (83 FR 39288)), the 
category of small rural hospitals is included within the analysis of 
the impact of this proposed rule on small entities in general. As 
indicated in Table 18, the effect on facilities for FY 2020 is 
projected to be an aggregate positive impact of 2.5 percent. As the 
overall

[[Page 17689]]

impact on the industry as a whole is less than the 3 to 5 percent 
threshold discussed above, the Secretary has determined that this final 
rule will not have a significant impact on a substantial number of 
small rural hospitals for FY 2020.

C. Unfunded Mandates Reform Act Analysis

    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 2019, that 
threshold is approximately $154 million. This proposed rule will impose 
no mandates on state, local, or tribal governments or on the private 
sector.

D. Federalism Analysis

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues 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. This proposed rule would have no substantial direct 
effect on state and local governments, preempt state law, or otherwise 
have federalism implications.

E. Reducing Regulation and Controlling Regulatory Costs

    Executive Order 13771 (January 30, 2017) requires that the costs 
associated with significant new regulations ``to the extent permitted 
by law, be offset by the elimination of existing costs associated with 
at least two prior regulations.'' This proposed rule is not subject to 
the requirements of E.O. 13771 because it is expected to result in no 
more than de minimis costs.

F. Congressional Review Act

    This proposed regulation is subject to the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress 
and the Comptroller General for review.

G. Regulatory Review Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this proposed rule, we 
should estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on last year's proposed rule will be the number of reviewers 
of this year's proposed rule. We acknowledge that this assumption may 
understate or overstate the costs of reviewing this rule. It is 
possible that not all commenters reviewed last year's rule in detail, 
and it is also possible that some reviewers chose not to comment on the 
proposed rule. For these reasons, we thought that the number of past 
commenters would be a fair estimate of the number of reviewers of this 
rule. We welcome any comments on the approach in estimating the number 
of entities which will review the proposed rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this proposed rule, 
and therefore, for the purposes of our estimate we assume that each 
reviewer reads approximately 50 percent of the rule. We seek comments 
on this assumption.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $107.38 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average 
reading speed, we estimate that it would take approximately 4 hours for 
the staff to review half of the proposed rule. For each SNF that 
reviews the rule, the estimated cost is $429.52 (4 hours x $107.38). 
Therefore, we estimate that the total cost of reviewing this regulation 
is $124,561 ($429.52 x 290 reviewers).
    In accordance with the provisions of Executive Order 12866, this 
proposed rule was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 413

    Diseases, Health facilities, Medicare, Reporting and recordkeeping 
requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 409--HOSPITAL INSURANCE BENEFITS

0
1. The authority citation for part 409 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


Sec.  409.30   [Amended]

0
2. Section 409.30 is amended in the introductory text by removing the 
phrase ``the 5-day assessment'' and adding in its place the phrase 
``the initial patient assessment''.

PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR 
END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT 
RATES FOR SKILLED NURSING FACILITIES; PAYMENT FOR ACUTE KIDNEY 
INJURY DIALYSIS

0
3. The authority citation for part 413 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), 
(i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww; and sec. 
124 of Public Law 106-113, 113 Stat. 1501A-332; sec. 3201 of Public 
Law 112-96, 126 Stat. 156; sec. 632 of Public Law 112-240, 126 Stat. 
2354; sec. 217 of Public Law 113-93, 129 Stat. 1040; and sec. 204 of 
Public Law 113-295, 128 Stat. 4010; and sec. 808 of Public Law 114-
27, 129 Stat. 362.

0
4. Section 413.343 is amended by revising paragraph (b) to read as 
follows:


Sec.  413.343   Resident assessment data.

* * * * *
    (b) Assessment schedule. In accordance with the methodology 
described in Sec.  413.337(c) related to the adjustment of the Federal 
rates for case-mix, SNFs must submit assessments according to an 
assessment schedule. This schedule must include performance of an 
initial patient assessment no later than the 8th day of posthospital 
SNF care and such other interim payment assessments as the SNF 
determines are necessary to account for changes in patient care needs.
* * * * *
0
5. Section 413.360 is amended by revising paragraphs (a) and (d)(1) and 
(4) to read as follows:


Sec.  413.360   Requirements under the Skilled Nursing Facility (SNF) 
Quality Reporting Program (QRP).

    (a) Participation start date. Beginning with the FY 2018 program 
year, a SNF must begin reporting data in accordance with paragraph (b) 
of this section no later than the first day of the calendar quarter 
subsequent to 30 days after the date on its CMS Certification Number 
(CCN) notification letter, which designates the SNF as operating in the 
CMS designated data submission system. For purposes of this section, a 
program year is the fiscal year in which the market basket percentage 
described in Sec.  413.337(d) is reduced by two percentage points if 
the SNF does not

[[Page 17690]]

report data in accordance with paragraph (b) of this section.
* * * * *
    (d) * * *
    (1) SNFs that do not meet the requirements in paragraph (b) of this 
section for a program year will receive a notification of non-
compliance sent through at least one of the following methods: The CMS 
designated data submission system, the United States Postal Service, or 
via an email from the Medicare Administrative Contractor (MAC). A SNF 
may request reconsideration no later than 30 calendar days after the 
date identified on the letter of non-compliance.
* * * * *
    (4) CMS will notify SNFs, in writing, of its final decision 
regarding any reconsideration request through at least one of the 
following methods: CMS designated data submission system, the United 
States Postal Service, or via email from the CMS Medicare 
Administrative Contractor (MAC).
* * * * *

    Dated: March 26, 2019.
Seema Verma
Administrator, Centers for Medicare & Medicaid Services.

    Dated: April 2, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-08108 Filed 4-19-19; 4:15 p.m.]
 BILLING CODE 4120-01-P