Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies, 40835-40890 [2013-16107]
Download as PDF
<![CDATA[
Vol. 78
Monday,
No. 130
July 8, 2013
Part II
Department of Health and Human Services
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Centers for Medicare & Medicaid Services
42 CFR Parts 413 and 414
Medicare Program; End-Stage Renal Disease Prospective Payment
System, Quality Incentive Program, and Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies; Proposed Rule
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00001
Fmt 4717
Sfmt 4717
E:\FR\FM\08JYP2.SGM
08JYP2
40836
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 413 and 414
[CMS–1526–P]
RIN 0938–AR55
Medicare Program; End-Stage Renal
Disease Prospective Payment System,
Quality Incentive Program, and
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This rule proposes to update
and make revisions to the End-Stage
Renal Disease (ESRD) prospective
payment system (PPS) for calendar year
(CY) 2014. This rule also proposes to set
forth requirements for the ESRD quality
incentive program (QIP), including for
payment year (PY) 2016 and beyond. In
addition, this rule proposes to clarify
the grandfathering provision related to
the 3-year minimum lifetime
requirement (MLR) for Durable Medical
Equipment (DME). In addition, it
provides clarification of the definition
of routinely purchased DME. This rule
also proposes the implementation of
budget-neutral fee schedules for splints
and casts, and intraocular lenses (IOLs)
inserted in a physician’s office. Finally,
this rule would make a few technical
amendments and corrections to existing
regulations related to payment for
DMEPOS items and services.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. E.S.T on August 30, 2013.
ADDRESSES: In commenting, please refer
to file code CMS–1526–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1526–P, P.O. Box 8010, Baltimore,
MD 21244–8010.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
SUMMARY:
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
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–1526–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following addresses prior to the close of
the comment period: a. For delivery in
Washington, DC—Centers for Medicare
& Medicaid Services, Department of
Health and Human Services, Room 445–
G, Hubert H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Michelle Cruse, (410) 786–7540, for
issues related to the ESRD PPS.
Stephanie Frilling, (410) 786–4507, for
issues related to the ESRD PPS wage
index, home dialysis training, and the
delay in payment for oral-only drugs
under the ESRD PPS.
Heidi Oumarou, (410) 786–7942, for
issues related to the ESRD market
basket.
Anita Segar, (410) 786–4614, for issues
related to the ESRD QIP.
Sandhya Gilkerson, (410) 786–4085, for
issues related to the clarification of
the grandfathering provision related
to the 3-year MLR for DME.
Anita Greenberg (410) 786–4601, for
issues related to the clarification of
PO 00000
Frm 00002
Fmt 4701
Sfmt 4702
the definition of routinely purchased
DME.
Christopher Molling (410) 786–6399, for
issues related to DMEPOS technical
amendments and corrections.
Hafsa Vahora, (410) 786–7899, for issues
related to the implementation of
budget neutral fee schedules for
splints and casts, and IOLs inserted in
a physician’s office.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
Electronic Access
This Federal Register document is
also available from the Federal Register
online database through Federal Digital
System (FDsys), a service of the U.S.
Government Printing Office. This
database can be accessed via the
internet at https://www.gpo.gov/fdsys/.
Addenda Are Only Available Through
the Internet on the CMS Web site
In the past, a majority of the Addenda
referred to throughout the preamble of
our proposed and final rules were
available in the Federal Register.
However, the Addenda of the annual
proposed and final rules will no longer
be available in the Federal Register.
Instead, these Addenda to the annual
proposed and final rules will be
available only through the Internet on
the CMS Web site. The Addenda to the
End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS) rules
are available at: https://www.cms.gov/
ESRDPayment/PAY/list.asp. Readers
who experience any problems accessing
any of the Addenda to the proposed and
final rules of the ESRD PPS that are
posted on the CMS Web site identified
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
above should contact Michelle Cruse at
410–786–7540.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Table of Contents
To assist readers in referencing
sections contained in this preamble, we
are providing a Table of Contents. Some
of the issues discussed in this preamble
affect the payment policies, but do not
require changes to the regulations in the
Code of Federal Regulations (CFR).
I. Executive Summary
A. Purpose
1. End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS)
2. End-Stage Renal Disease (ESRD) Quality
Incentive Program (QIP)
3. Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS)
B. Summary of the Major Provisions
1. ESRD PPS
2. ESRD QIP
3. DMEPOS
C. Summary of Costs and Benefits
1. Impacts of the Proposed ESRD PPS
2. Impacts for ESRD QIP
3. Impacts for DMEPOS
II. Calendar Year (CY) 2013 End-Stage Renal
Disease (ESRD) Prospective Payment
System (PPS)
A. Background on the End-Stage Renal
Disease (ESRD) Prospective Payment
System (PPS)
B. Routine Updates and Proposed Policy
Changes to the CY 2014 ESRD PPS
1. Composite Rate Portion of the ESRD PPS
Blended Payment
2. ESRD PPS Base Rate
a. Proposed Adjustment to the ESRD PPS
Base Rate to Reflect Change in
Utilization of ESRD-Related Drugs and
Biologicals
i. Methodology for Reducing the CY 2014
ESRD PPS Base Rate
ii. Determining Utilization of ESRD-Related
Drugs and Biologicals
iii. Pricing of ESRD-Related Drugs and
Biologicals
iv. Calculation of the Amount of the Per
Treatment Reduction
v. Comparison of ASP versus PPI
3. ESRD Bundled Market Basket
a. Overview and Background
b. Proposed Market Basket Update Increase
Factor and Labor-related Share for ESRD
Facilities for CY 2014
c. Proposed Productivity Adjustment
d. Calculation of the ESRDB Market Basket
Update, Adjusted for Multifactor
Productivity for CY 2014
4. The Proposed CY 2014 Wage Index
a. Payment Under the ESRD PPS for
Facilities Located in Guam, American
Samoa, and the Northern Mariana
Islands and Proposed Wage Index Value
for Guam
b. Proposed Policies for Areas with No
Wage Data
c. Proposed Reduction to the ESRD Wage
Index Floor
d. Proposed Wage Index Budget-Neutrality
Adjustment
5. Application of the International
Classification of Diseases (ICD), Tenth
Revision, to the Comorbidity Payment
Adjustment Codes
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
a. One ICD–9–CM Code Crosswalks to One
ICD–10–CM Code
b. One ICD–9–CM Code Crosswalks to
Multiple ICD–10–CM Codes
c. Multiple ICD–9–CM Codes Crosswalk to
One ICD–10–CM Code
6. Proposed Revisions to the Outlier Policy
a. Impact of Proposed Changes to the
Outlier Policy
b. Outlier Policy Percentage
C. Discussion of Self-Dialysis and Home
Dialysis Training Add On Adjustment
and Request for Public Comments
a. Medicare Policy for Self-Dialysis
Training, Home Dialysis Training, and
Retraining
b. Payment Methodology
D. Delay of Payment for Oral-Only Drugs
Under the ESRD PPS
III. End-Stage Renal Disease (ESRD) Quality
Incentive Program (QIP)
A. Background
B. Considerations in Updating and
Expanding Quality Measures under the
ESRD QIP for PY 2016 and Subsequent
PYs
1. Value-Based Purchasing (VBP) Overview
2. Brief Overview of Proposed PY 2016
Measures
3. Measures Application Partnership
Review
C. Proposed Measures for the PY 2016
ESRD QIP and Subsequent PYs of the
ESRD QIP
1. PY 2015 Measures Continuing in PY
2016 and Future Payment Years
2. Proposal to Expand One PY 2015
Measure and Revise Two PY 2015
Measures for PY 2016 and Subsequent
Payment Years
a. Proposed Expanded ICH CAHPS
Reporting Measure
b. Proposed Revised Mineral Metabolism
Reporting Measure
c. Proposed Revised Anemia Management
Reporting Measure
3. New Measures Proposed for PY 2016
and Subsequent Payment Years of the
ESRD QIP
a. Proposed Clinical Anemia Management
Measure and Anemia Management
Clinical Measure Topic
i. Anemia Management: Hgb > 12
ii. Anemia of Chronic Kidney Disease:
Patient Informed Consent for Anemia
Treatment
b. Hypercalcemia
c. Use of Iron Therapy for Pediatric
Patients Reporting Measure
d. NHSN Bloodstream Infection in
Hemodialysis Outpatients Clinical
Measure
e. Comorbidity Reporting Measure
4. Other Measures under Development
5. Proposed Scoring for the PY 2016 ESRD
QIP and Future Payment Years
6. Proposed Performance Period for the PY
2016 ESRD QIP
7. Proposed Performance Standards for the
PY 2016 ESRD QIP and Future Payment
Years
a. Proposed Clinical Measure Performance
Standards
b. Estimated Performance Standards for
Proposed Clinical Measures
c. Proposed Performance Standards for
Reporting Measures
PO 00000
Frm 00003
Fmt 4701
Sfmt 4702
40837
8. Proposed Scoring for the PY 2016 ESRD
QIP Proposed Measures
a. Proposals for Scoring Facility
Performance on Clinical Measures Based
on Achievement
b. Proposals for Scoring Facility
Performance on Clinical Measures Based
on Improvement
c. Proposals for Calculating Facility
Performance on Reporting Measures
9. Proposals for Weighting the PY 2016
ESRD QIP Measures and Calculating the
PY 2016 ESRD QIP Total Performance
Score
a. Weighting Individual Measures to
Compute Measure Topic Scores for the
Kt/V Dialysis Adequacy measure topic,
the Vascular Access Type measure topic,
and the Anemia Management Clinical
measure topic
b. Proposal for Weighting the Total
Performance Score
c. Examples of the Proposed PY 2016 ESRD
QIP Scoring Methodology
10. Proposed Minimum Data for Scoring
Measures for the PY 2016 ESRD QIP and
Future Payment Years
11. Proposed Payment Reductions for the
PY 2016 ESRD QIP and Future Payment
Years
12. Data Validation
13. Proposals for Scoring Facilities Whose
Ownership has Changed
14. Proposals for Public Reporting
Requirements
IV. Clarification of the Definition of
Routinely Purchased Durable Medical
Equipment (DME)
A. Background
1. Background for DME
2. Medicare Guidance and Rulemaking
Regarding Definition of Routinely
Purchased DME
3. Payment for Inexpensive or Routinely
Purchased Items and Capped Rental
Items
B. Current Issues
C. Classification of Items under the
Existing Regulations and Definition of
Routinely Purchased Equipment
V. Clarification of the 3-year Minimum
Lifetime Requirement (MLR) for DME
A. Background
B. Current Issues
C. Scope of the 3-Year MLR
VI. Implementation of Budget-Neutral Fee
Schedules for Splints, Casts and
Intraocular Lenses (IOLs)
A. Background
1. Payment Under Reasonable Charges
2. Payment Under Fee Schedules
B. Provisions of the Proposed Regulations
VII. DMEPOS Technical Amendments and
Corrections
A. Background
B. Proposed Technical Amendments and
Corrections
VIII. Collection of Information Requirements
A. Legislative Requirement for Solicitation
of Comments
B. Requirements in Regulation Text
C. Additional Information Collection
Requirements
1. ESRD QIP
a. Proposed Expanded ICH CAHPS
Reporting Measure for PY 2016 and
Future Payment Years of the ESRD QIP
E:\FR\FM\08JYP2.SGM
08JYP2
40838
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
b. Proposed Data Validation Requirements
for the PY 2016 ESRD QIP
2. Clarification of the Definition of
Routinely Purchased Durable Medical
Equipment
3. Clarification of the 3-year Minimum
Lifetime Requirement for DME
4. Implementation of Budget-Neutral Fee
Schedules for Splints, Casts and
Intraocular Lenses
IX. Response to Comments
X. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
2. Statement of Need
3. Overall Impact
B. Detailed Economic Analysis
1. CY 2014 End-Stage Renal Disease
Prospective Payment System
a. Effects on ESRD Facilities
b. Effects on Other Providers
c. Effects on the Medicare Program
d. Effects on Medicare Beneficiaries
e. Alternatives Considered
2. End-Stage Renal Disease Quality
Incentive Program
a. Effects of the PY 2016 ESRD QIP
b. Alternatives Considered for the PY 2016
ESRD QIP
3. DMEPOS Provisions
a. Effects of the Implementation of Fee
Schedules for Splints, Casts and IOLs
b. Clarification of the 3-year MLR
c. Definition of Routinely Purchased DME
C. Accounting Statement.
XI. Regulatory Flexibility Act Analysis
XII. Unfunded Mandates Reform Act
Analysis
XIII. Federalism Analysis
XIV. Congressional Review Act
XV. Files Available to the Public via the
Internet
Regulations Text
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Acronyms
Because of the many terms to which
we refer by acronym in this final rule,
we are listing the acronyms used and
their corresponding meanings in
alphabetical order below:
AHRQ Agency for Healthcare Research and
Quality
ASP Average Sales Price
BLS Bureau of Labor Statistics
CBSA Core based statistical area
CCN CMS Certification Number
CDC Centers for Disease Control and
Prevention
CKD Chronic Kidney Disease
CY Calendar Year
DFC Dialysis Facility Compare
DME Durable Medical Equipment
DMEPOS Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
ESA Erythropoiesis stimulating agent
ESRD End-Stage Renal Disease
ESRDB End-Stage Renal Disease bundled
ESRD PPS End-Stage Renal Disease
Prospective Payment System
FDA Food and Drug Administration
GEM General Equivalence Mappings
HAIs Healthcare-Acquired Infections
HCPCS Healthcare Common Procedure
Coding System
HHS Department of Health and Human
Services
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
ICD International Classification of Diseases
ICD–9–CM International Classification of
Disease, 9th Revision, Clinical
Modification
ICH CAHPS In-Center Hemodialysis
Consumer Assessment of Healthcare
Providers and Systems
IGI IHS Global Insight
IOLs Intraocular Lenses
IPPS Inpatient Prospective Payment System
MAP Medicare Allowable Payment
MFP Multifactor Productivity
MLR Minimum Lifetime Requirement
NHSN National Health Safety Network
NQF National Quality Forum
OMB Office of Management and Budget
PFS Physician Fee Schedule
QIP Quality Incentive Program
SHR Standardized Hospitalization Ratio
Admissions
SMR Standardized Mortality Ratio
TPS Total Performance Score
VBP Value Based Purchasing
under the ESRD PPS before January 1,
2016.
I. Executive Summary
This rule would clarify the definition
of routinely purchased equipment
covered under the DME benefit category
and the scope of the 3-year minimum
lifetime requirement (MLR) for DME. In
addition, this rule proposes to
implement budget neutral fee schedules
for splints and casts as well as
intraocular lenses (IOLs) inserted in a
physician’s office. Finally, this rule
would make a few technical
amendments and corrections to existing
regulations related to payment for
DMEPOS items and services.
A. Purpose
1. End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS)
On January 1, 2011, we implemented
the ESRD PPS, a case-mix adjusted
bundled prospective payment system
for renal dialysis services furnished by
ESRD facilities. Effective January 1,
2014, the transition to the ESRD PPS
will conclude and all Medicare ESRD
facilities will be paid 100 percent under
the ESRD PPS. This rule proposes to
update and make revisions to the EndStage Renal Disease (ESRD) prospective
payment system (PPS) for calendar year
(CY) 2014. In accordance with section
1881(b)(14) of the Social Security Act
(the Act), as added by section 153(b) of
the Medicare Improvements for Patients
and Providers Act of 2008 (MIPPA)
(Public Law 110–275), and section
1881(b)(14)(F) of the Act, as added by
section 153(b) of MIPPA and amended
by section 3401(h) of the Affordable
Care Act (ACA) (Pub. L. 111–148),
established that beginning CY 2012, and
each subsequent year, the Secretary
shall reduce the market basket increase
factor by a productivity adjustment
described in section 1886(b)(3)(B)(xi)(II)
of the Act.
In addition, section 1881(b)(14)(I) of
the Act, as added by section 632(a) of
the American Taxpayer Relief Act of
2012 (ATRA) (Pub. L. 112–240) requires
the Secretary, by comparing per patient
utilization from 2007 with such data
from 2012, to reduce the single payment
amount to reflect the Secretary’s
estimate of the change in the utilization
of ESRD-related drugs and biologicals.
Section 632(b) of ATRA prevents the
Secretary from paying for oral-only
ESRD-related drugs and biologicals
PO 00000
Frm 00004
Fmt 4701
Sfmt 4702
2. End-Stage Renal Disease (ESRD)
Quality Incentive Program (QIP)
This rule also proposes to set forth
requirements for the ESRD Quality
Incentive Program (QIP), including for
payment year (PY) 2016. The program is
authorized under section 153(c) of
MIPPA, which added section 1881(h) to
the Social Security Act (the Act). The
ESRD QIP is the most recent step in
fostering improved patient outcomes by
establishing incentives for dialysis
facilities to meet performance standards
established by CMS.
3. Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS)
B. Summary of the Major Provisions
1. ESRD PPS
• Update to the ESRD PPS base rate
for CY 2014: For CY 2014, we propose
an ESRD PPS base rate of $216.95. This
amount reflects the application of the
proposed ESRD bundled (ESRDB)
market basket reduced by the
productivity adjustment, or 2.5 percent,
the wage index budget-neutrality
adjustment factor of 1.000411, and the
drug utilization adjustment to the CY
2013 ESRD PPS base rate of $240.36.
The proposed CY 2014 ESRDB market
basket increase factor is 2.9 percent. The
current forecast of the proposed CY
2014 productivity adjustment is 0.4
percent. The proposed drug utilization
adjustment factor to account for changes
in utilization as required by section
1881(b)(14)(I) is ¥12 percent.
• Updates to the wage index and
wage index floor: We adjust wage
indices on an annual basis using the
most current hospital wage data to
account for differing wage levels in
areas in which ESRD facilities are
located. In CY 2014, we are not
proposing any changes to the
application of the wage index budgetneutrality adjustment factor and will
continue to apply the budget-neutrality
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
adjustment to the base rate for the ESRD
PPS. We have been gradually decreasing
the wage index floor by .05 in an effort
to gradually phase out the floor. For CY
2014 and CY 2015 we are proposing to
continue our policy for the gradual
phase out of the wage index floor and
to reduce the wage index floor values to
0.45 and 0.40, respectively.
• Update to the outlier policy: We are
updating the outlier services fixed
dollar loss amounts for adult and
pediatric patients and Medicare
Allowable Payments (MAPs) for adult
patients for CY 2014 using 2012 claims
data. Based on the use of more current
data, the fixed-dollar loss amount for
pediatric beneficiaries would increase
from $47.32 to $54.23 and the MAP
amount would remain $38.65 as
compared to CY 2013 values. For adult
beneficiaries, the fixed-dollar loss
amount would decrease from $110.22 to
$94.26 and the MAP amount would
decrease from $61.38 to $52.45. The 1
percent target for outlier payments was
not achieved in CY 2012. We believe
using CY 2012 claims data to update the
outlier MAP and fixed dollar loss
amounts for CY 2014 will increase
payments for ESRD beneficiaries
requiring higher resource utilization in
accordance with a 1 percent outlier
percentage.
• Application of ICD–10–CM
Diagnosis Codes to the comorbidity
payment adjustment codes: Effective
October 1, 2014, CMS will implement
the 10th revision of the ICD coding
scheme. We discuss and provide a
crosswalk from ICD–9–CM to ICD–10–
CM for codes that are subject to the
comorbidity payment adjustment. We
propose that all ICD–10–CM codes to
which ICD–9–CM codes that are eligible
for the comorbidity payment adjustment
crosswalk will be eligible for the
comorbidity payment adjustment with
two exceptions.
2. ESRD QIP
This proposed rule proposes to
implement requirements for the ESRD
QIP. With respect to the PY 2016 ESRD
QIP, we propose to continue some of the
previous ESRD QIP measures, add new
measures, and expand the scope of some
of the existing measures to cover the
measure topics as follows:
• To evaluate anemia management:
Æ Hemoglobin Greater Than 12 g/dL,
a clinical measure
Æ Patient Informed Consent for
Anemia Treatment, a clinical
measure*
Æ Anemia Management, a reporting
measure†
Æ Pediatric Iron Therapy, a reporting
measure*
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
• To evaluate dialysis adequacy:
Æ A Kt/V measure for adult
hemodialysis patients, a clinical
measure
Æ A Kt/V measure for adult peritoneal
dialysis patients, a clinical measure
Æ A Kt/V measure for pediatric
hemodialysis patients, a clinical
measure
• To determine whether patients are
treated using the most beneficial
type of vascular access:
Æ An arteriovenous fistula measure, a
clinical measure
Æ A catheter measure, a clinical
measure
• To address effective bone mineral
metabolism management:
Æ Hypercalcemia, a clinical measure*
Æ Mineral Metabolism, a reporting
measure†
• To address safety:
Æ National Healthcare Safety Network
(NHSN) Bloodstream Infection in
Hemodialysis Outpatients, a
clinical measure*
• To assess patient experience:
Æ ICH CAHPS survey reporting
measure‡
• To gather data regarding
comorbidities:
Æ Comorbidity, a reporting measure*
* Denotes that this measure is new to
the ESRD QIP.
† Denotes that this measure is revised in
the ESRD QIP.
‡ Denotes that this measure is expanded
in the ESRD QIP.
It also proposes to establish CY 2014
as the performance period for the PY
2016 ESRD QIP, establish performance
standards for each measure, and adopt
scoring and payment reduction
methodologies that are similar to those
finalized for the PY 2015 ESRD QIP.
3. DMEPOS
• Definition of routinely purchased
DME: This rule would clarify the
definition of routinely purchased DME
set forth at section § 414.220(a), as well
as address the classification of and
payment for expensive items of DME
and accessories (over $150) as a capped
rental items in accordance with
§ 414.229, if the items were not acquired
by purchase on a national basis at least
75 percent of the time during the period
July 1986 through June 1987.
• Clarification of to the 3-year MLR
and Related Grandfathering Policy: This
rule would provide further clarification
about how we would apply the 3-year
minimum lifetime requirement (MLR)
set forth at § 414.202, which must be
satisfied for an item or device to be
considered durable medical equipment.
• Implementation of budget neutral
fee schedules for splints and casts, and
PO 00000
Frm 00005
Fmt 4701
Sfmt 4702
40839
IOLs inserted in a physician’s office: For
CY 2014, we are proposing to
implement budget neutral fee schedule
amounts for splints, casts, and IOLs
inserted in a physician’s office. Section
1842(s) of the Act authorizes CMS to
implement fee schedule amounts for
these items if they established so that
they are initially budget neutral. In
2011, total allowed charges for splints
and casts were $5.6 million, while total
allowed charges for intraocular lenses
inserted in a physician’s office were $76
thousand.
C. Summary of Costs and Benefits
In section X.B. of this proposed rule,
we set forth a detailed analysis of the
impacts that the proposed changes
would have on affected entities and
beneficiaries. The impacts include the
following:
1. Impacts of the Proposed ESRD PPS
The impact chart in section X.B.1. of
this proposed rule displays the
estimated change in payments to ESRD
facilities in CY 2014 compared to
estimated payments in CY 2013. The
overall impact of the CY 2014 changes
is projected to be a 9.4 percent decrease
in payments. Hospital-based ESRD
facilities have an estimated 9.3 percent
decrease in payments compared with
freestanding facilities with an estimated
9.4 percent decrease.
We estimate that the aggregate ESRD
PPS expenditures would decrease by
approximately $780 million from CY
2013 to CY 2014. This reflects a $210
million increase from the payment rate
update, a $30 million increase due to
the updates to the outlier threshold
amounts, and a $1.02 billion decrease in
expenditures specifically related to the
¥12 percent drug utilization adjustment
required by section 1881(b)(14)(I). The
estimated 9.4 percent overall payment
decrease would result in a $190 million
savings to beneficiaries.
2. Impacts for ESRD QIP
The overall economic impact of the
proposed ESRD QIP is an estimated
$26.4 million in PY 2016. In PY 2016,
we expect the total payment reductions
to be approximately $26.4 million, and
the costs associated with the collection
of information requirements for certain
measures to be approximately $39.5
thousand. For PY 2017 and future
payment years, we expect the costs
associated with the collection of
information requirements for the
expanded ICH CAHPS measure in the
proposed ESRD QIP to be approximately
$9.7 million.
The ESRD QIP will continue to
incentivize facilities to provide higher
E:\FR\FM\08JYP2.SGM
08JYP2
40840
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
quality care to beneficiaries. The
reporting measures associated with the
collection of information requirements
are critical to better understanding the
quality of care beneficiaries receive,
particularly patients’ experience of care,
and will be used to incentivize
improvements in the quality of care
provided.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
3. Impacts for DMEPOS
The overall impact of the DMEPOS
proposal to implement fee schedules for
splints and casts and IOLs inserted in a
physician’s office is insignificant. The
reasonable charge amounts that we
propose to convert to fee schedule
amounts would be budget neutral the
first year and would be updated
annually thereafter based on the
consumer price index for all consumers
(CPI–U) for the 12-month period ending
June 30 of the previous year and,
reduced by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II)
of the Act. For the 3-year MLR, we
believe that a vast majority of the
categories of items that were classified
as DME before January 1, 2012, did
function for 3 or more years (76 FR
70289). The 3-year MLR is designed to
represent a minimum threshold for
determination of durability for
equipment that is consistent with the
statutory DME payment provisions and
applies on a prospective basis, effective
January 1, 2012. CMS recognizes that
the healthcare industry and
beneficiaries have come to rely on items
that have qualified as DME on or prior
to January 1, 2012, regardless of whether
those items met the 3-year MLR set forth
at § 414.202. We note that given that
reliance and consistent with the
regulation at § 414.202, CMS will not
reopen those prior decisions and
reclassify the equipment in light of the
new 3-year standard. We believe that
continuing the Medicare coverage for all
the items that qualified as DME on or
prior to January 1, 2012, could avoid
disrupting the continuity of care for the
beneficiaries that received these items
for medical treatment prior to January 1,
2012, without creating a significant
fiscal impact on the Medicare Program.
We expect that the overall impact of
reaffirming the definition of routinely
purchased DME and our proposal for
classifying certain expensive items as
cap rental would be a decrease in
expenditures because payment on a 13month capped rental basis rather than a
lump sum purchase basis for certain,
very expensive items would lower total
payments for these items and because
many beneficiaries would not rent the
items for as long as 13 months.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
II. Calendar Year (CY) 2014 End-Stage
Renal Disease (ESRD) Prospective
Payment System (PPS)
A. Background on the End-Stage Renal
Disease (ESRD) Prospective Payment
System (PPS)
On August 12, 2010, we published in
the Federal Register a final rule (75 FR
49030 through 49214) titled, ‘‘End-Stage
Renal Disease Prospective Payment
System’’, hereinafter referred to as the
CY 2011 ESRD PPS final rule. In the CY
2011 ESRD PPS final rule, we
implemented a case-mix adjusted
bundled PPS for Medicare outpatient
ESRD dialysis services beginning
January 1, 2011, in accordance with
section 1881(b)(14) of the Act, as added
by section 153(b) of MIPPA.
On November 10, 2011, we published
in the Federal Register, a final rule (76
FR 70228 through 70316) titled,
‘‘Medicare Program; End-Stage Renal
Disease Prospective Payment System
and Quality Incentive Program;
Ambulance Fee Schedule; Durable
Medical Equipment; and Competitive
Acquisition of Certain Durable Medical
Equipment, Prosthetics, Orthotics and
Supplies’’ (hereinafter referred to as the
CY 2012 ESRD PPS final rule). In that
final rule, for the ESRD PPS, we made
a number of routine updates for CY
2012, implemented the second year of
the transition to the ESRD PPS, made
several policy changes and
clarifications, and made technical
changes.
On November 9, 2012, we published
in the Federal Register, a final rule (77
FR 67450 through 67531) titled,
‘‘Medicare Program; End-Stage Renal
Disease Prospective Payment System,
Quality Incentive Program, and Bad
Debt Reductions for All Medicare
Providers’’ (hereinafter referred to as the
CY 2013 ESRD PPS final rule). In that
final rule, for the ESRD PPS, we made
a number of routine updates for CY
2013, implemented the third year of the
transition to the ESRD PPS, and made
several policy changes and reiterations.
In that rule, we finalized the following:
• An ESRD PPS base rate of $240.36
per treatment for renal dialysis services.
The ESRD PPS base rate applies to the
ESRD PPS portion of the blended
payments during the transition and to
the ESRD PPS payments. This amount
reflected the CY 2013 ESRD bundled
(ESRDB) market basket update of 2.9
percent minus a multifactor
productivity adjustment of 0.6 percent,
that is, a 2.3 percent increase. This
amount also reflected the application of
the wage index budget-neutrality
adjustment of 1.000613.
PO 00000
Frm 00006
Fmt 4701
Sfmt 4702
• A composite base rate of $145.20
per treatment for renal dialysis services
that is used in the composite rate
portion of the ESRD PPS payment for
ESRD facilities receiving blended
payments during the transition. This
amount reflected the application of the
ESRDB market basket reduced by the
multifactor productivity adjustment, or
a 2.3 percent increase.
• A zero update to the drug add-on
adjustment and maintaining the $20.33
per treatment drug add-on amount for
the composite rate portion of the ESRD
PPS blended payment. This resulted in
a 14.0 percent drug add-on adjustment
to the composite rate portion of the
ESRD PPS blended payment.
• A 0.1 percent transition budgetneutrality adjustment factor.
• A 1.001141 wage index budgetneutrality adjustment factor for the
composite portion of the ESRD PPS
blended payment, which is applied to
the wage index values.
• A 1.000613 wage index budgetneutrality adjustment factor for the
ESRD PPS portion of the blended
payment and for the ESRD PPS, which
is applied to the ESRD PPS base rate.
• A 0.05 reduction to the wage index
floor which resulted in a wage index
floor of 0.500 under the ESRD PPS.
• A 0.501 wage index floor under the
composite rate portion of the blended
payment (1.500 × 1.001141 = 0.501).
• Revisions to the outlier policy.
Specifically, for pediatric beneficiaries,
a fixed-dollar loss amount of $47.32 and
a Medicare Allowable Payment (MAP)
amount of $41.39. For adult
beneficiaries, a fixed-dollar loss amount
of $110.22 and a MAP amount of
$59.42.
• Eliminating the restriction on
daptomycin to allow ESRD facilities to
receive separate payment by appending
the AY modifier on the claim for
daptomycin when the diagnosis
reported on the claim indicates the drug
was used to treat a non-ESRD related
condition.
• Excluding alteplase and other
thrombolytics from separate payment
for the composite rate portion of
blended payments during the remainder
of the transition.
• Use of the Average Sales Price
(ASP) methodology, including any
modifications finalized in the Physician
Fee Schedule (PFS) final rules, to
compute outlier MAP amounts, the drug
add-on, and any other policy that
requires the use of payment amounts for
drugs and biologicals that would be
separately paid absent the ESRD PPS
and for the composite rate portion of the
blended payment during the transition.
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
Finally, in the CY 2013 ESRD PPS
final rule, we reiterated policies
regarding the following billing practices
because we believed that ESRD facilities
may be billing renal dialysis services for
separate payment:
• Any item or service included in the
composite rate should not be identified
on ESRD claims.
• An AY modifier can be appended to
claims for drugs and laboratory tests
that are not ESRD-related to allow for
separate payment. The AY modifier
should not be used for renal dialysis
services and we have monitoring efforts
in place to analyze billing trends.
B. Routine Updates and Proposed Policy
Changes to the CY 2014 ESRD PPS
1. Composite Rate Portion of the ESRD
PPS Blended Payment
Section 1881(b)(14)(E)(i) of the Act
requires a 4-year transition under the
ESRD PPS. We are proposing to
implement the fourth year of the
transition for those ESRD facilities that
did not elect to receive 100 percent of
the payment amount under the ESRD
PPS. For CY 2014, under 42 CFR
413.239(a)(4), 100 percent of the
payment amount will be determined in
accordance with section 1881(b)(14).
Accordingly, a blended rate will no
longer be provided, all facilities will be
paid 100 percent under the ESRD PPS,
and there will no longer be a transition
budget neutrality adjustment factor
applied to these payments starting on
January 1, 2014. Therefore, facilities that
participate in the transition will no
longer receive a portion of their
payments based on the basic case-mix
adjusted composite rate payment
system. Because payments will no
longer be based on the basic case-mix
adjusted composite rate, we will not
update the drug add-on or wage index
values (which included a budget
neutrality adjustment factor) that
comprised that rate. In this proposed
rule we only discuss updates and policy
changes that affect the components of
the ESRD PPS.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
2. ESRD PPS Base Rate
In the CY 2011 ESRD PPS final rule
(75 FR 49071 through 49083), we
discussed the development of the ESRD
PPS per treatment base rate that is
codified in the Medicare regulations at
§ 413.220 and § 413.230. The CY 2011
ESRD PPS final rule also provides a
detailed discussion of the methodology
used to calculate the ESRD PPS base
rate and the computation of factors used
to adjust the ESRD PPS base rate for
projected outlier payments and budgetneutrality in accordance with sections
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii)
of the Act, respectively. Specifically, the
ESRD PPS base rate was developed from
CY 2007 claims (that is, the lowest per
patient utilization year as required by
section 1881(b)(14)(A)(ii) of the Act),
updated to CY 2011, and represented
the average per treatment Medicare
Allowable Payment (MAP) for
composite rate and separately billable
services. In accordance with section
1881(b)(14)(D) of the Act and codified in
regulations at § 413.230, the ESRD PPS
base rate is adjusted for the patientspecific case-mix adjustments,
applicable facility adjustments,
geographic differences in area wage
levels using an area wage index, as well
as applicable outlier payments or
training payments.
As discussed in section II.B.3., section
1881(b)(14)(F)(i) of the Act, as added by
section 153(b) of MIPPA and amended
by section 3401(h) of the Affordable
Care Act, provides that, beginning in
2012, the ESRD PPS payment amounts
are required to be annually increased by
the rate of increase in the ESRD market
basket, reduced by the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II). Accordingly, for
this proposed rule, we applied the 2.5
percent increase to the CY 2013 ESRD
PPS base rate of $240.36, which results
in a proposed CY 2014 ESRD PPS base
rate of $246.37 ($240.36 × 1.025 =
$246.37).
In addition, as discussed in section
II.B.4.d. of this proposed rule, for CY
2014 we are applying the wage index
budget-neutrality adjustment factor of
1.000411 to the CY 2014 ESRD PPS base
rate (that is, $246.37), yielding a
proposed CY 2014 ESRD PPS wageindex budget-neutrality adjusted base
rate of $246.47 ($246.37 × 1.000411 =
$246.47).
a. Proposed Adjustment to the ESRD
PPS Base Rate to Reflect Change in
Utilization of ESRD-Related Drugs and
Biologicals
Section 1881(b)(14)(I) of the Act, as
added by section 632(a) of the American
Taxpayer Relief Act of 2012 (ATRA),
requires that, for services furnished on
or after January 1, 2014, the Secretary
shall make reductions to the single
payment for renal dialysis services to
reflect the Secretary’s estimate of the
change in the utilization of ESRDrelated drugs and biologicals (excluding
oral-only ESRD-related drugs) by
comparing per patient utilization data
from 2007 with such data from 2012.
Section 1881(b)(14)(I) further requires
that in making the reductions, the
Secretary take into account the most
recently available data on Average Sales
PO 00000
Frm 00007
Fmt 4701
Sfmt 4702
40841
Prices (ASP) and changes in prices for
drugs and biologicals reflected in the
ESRD market basket percentage increase
factor under section 1881(b)(14)(F).
Consistent with these requirements, we
propose to apply a payment adjustment
to the CY 2014 ESRD PPS base rate that
reflects the change in utilization of
ESRD-related drugs and biologicals from
CY 2007 to CY 2012.
i. Methodology for Reducing the CY
2014 ESRD PPS Base Rate
We are proposing an adjustment that
would reduce the ESRD PPS base rate.
Because the ESRD PPS base rate is a per
treatment base rate, the adjustment
would be calculated on a per treatment
basis. We propose to calculate the
amount of the per treatment adjustment
by applying CY 2014 prices for ESRDrelated drugs and biologicals to the
utilization data for CY 2007 and CY
2012. We note the CY 2014 ESRD PPS
base rate is reflective of 2007 utilization
because the base rate is based on CY
2007 data. We believe using prices for
drugs and biologicals inflated to 2014
levels allows us to appropriately
measure changes that are attributable to
utilization patterns as opposed to
differences in pricing for drugs and
biologicals in 2007 and 2012. In
addition, we believe that because we are
proposing to make the reduction in CY
2014, we should price the ESRD-related
drugs and biologicals for the year in
which the adjustment applies. For
purposes of this analysis, we view
utilization of drugs and biologicals as
units of a drug or biological furnished
to a patient per treatment for ESRD. We
would take the estimated amount of the
per treatment difference between the
estimated spending of drugs and
biologicals in CY 2007 and CY 2012 and
reduce this amount by the same
adjustment factors that were used to
calculate the ESRD PPS base rate from
the CY 2007 unadjusted rate per
treatment, which are the
standardization, outlier, and the 98
percent budget-neutrality adjustments.
A detailed explanation of these
adjustment factors is provided in the CY
2011 ESRD PPS final rule (75 FR 49081
through 49082). We propose to reduce
the CY 2014 ESRD PPS base rate by the
resulting amount.
ii. Determining Utilization of ESRDRelated Drugs and Biologicals
Section 1881(b)(14)(I) requires the
single payment amount to be reduced by
an amount that ‘‘reflects the Secretary’s
estimate of the change in utilization of
drugs and biologicals described in
clauses (ii), (iii), and (iv) of
subparagraph (B) (other than oral-only
E:\FR\FM\08JYP2.SGM
08JYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
40842
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
ESRD-related drugs, as such term is
used in the final rule promulgated by
the Secretary in the Federal Register on
August 12, 2010 (75 FR 49030))’’. As we
mentioned above, for purposes of this
analysis, we view utilization of drugs
and biologicals as units of a drug or
biological furnished to a patient per
treatment. ESRD facilities report this
information on claims. To calculate this
adjustment, we analyzed the utilization
of erythropoiesis stimulating agents
(ESAs) and any oral forms of such
agents furnished to individuals for the
treatment of ESRD. We also analyzed
the utilization of other injectable drugs
and biologicals (such as iron sucrose
and doxercalciferol) and any oral
equivalent form of such drug or
biological furnished to individuals for
the treatment of ESRD that were
included in the expanded bundle of
services covered by the ESRD PPS. We
did not include diagnostic laboratory
tests or other items and services in the
comparison analysis because section
1811(b)(14)(I) only refers to estimating
the change in utilization of drugs and
biologicals.
Section 1881(b)(14)(I) of the Act
requires the Secretary to compare per
patient utilization data from 2007 with
per patient utilization data from 2012.
For the CY 2007 utilization data for
ESRD-related drugs and biologicals, we
propose to use the data analysis
prepared for the CY 2011 ESRD PPS
final rule. In the CY 2011 ESRD PPS
final rule (75 FR 49071 through 49083)
we discuss in detail the development of
the ESRD PPS base rate and as we stated
above, the base rate represents the
average MAP for composite rate and
separately billable services which was
based on 2007 claims data. We explain
in the CY 2011 ESRD PPS final rule that
in order to comply with section
1881(b)(14)(A)(ii) of the Act we
determined that 2007 was the year with
the lowest per patient utilization of
renal dialysis services by Medicare
ESRD beneficiaries among the years
2007, 2008, and 2009. Therefore,
utilization data for ESAs and other
drugs and biologicals including the oralequivalent forms of those drugs and
biologicals furnished for the treatment
of ESRD was readily available for
purposes of analyzing 2007 utilization.
For the CY 2012 utilization data for
ESRD-related drugs and biologicals, we
propose to use the latest available
claims data based on the CY 2012 ESRD
facility claims updated through
December 31, 2012 (that is, claims with
dates of service from January 1 through
December 31, 2012, that were received,
processed, paid, and passed to the
National Claims History File as of
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
December 31, 2012). For the CY 2014
ESRD PPS final rule, we will use the CY
2012 claims file updated through June
30, 2013, (that is, claims with dates of
service from January 1 through
December 31, 2012, that were received,
processed, paid, and passed to the
National Claims History File as of June
30, 2013) to calculate 2012 utilization.
We solicit comments on the proposed
use of 2007 and 2012 claims data to
capture the utilization of ESRD-related
drugs and biologicals in those years.
Because section 1881(b)(14)(I)
requires that we compare per patient
utilization of ESRD-related drugs and
biologicals in 2007 with per patient
utilization in 2012, we believe that this
would also include utilization of drugs
and biologicals furnished in ESRD
facilities located in the United States
Territories of Guam, American Samoa
and the Northern Mariana Islands (the
Pacific Rim), even though facilities in
the Pacific Rim were not paid under the
ESRD PPS during these years. Therefore,
we propose to use 2007 and 2012
utilization of ESRD-related drugs and
biologicals (including oral equivalents)
for ESRD facilities located in these
territories in our analysis of the
reduction required by section
1881(b)(14)(I). For this proposed rule,
we did not readily have access to the
2007 utilization data for the ESRD
facilities located in these areas;
however, we plan to include these data
in our calculation for the final rule.
Because there are very few ESRD
facilities in this region, we do not
believe that the inclusion of utilization
of drugs and biologicals furnished in CY
2007 at these facilities will have a
significant impact on the amount of the
adjustment. We solicit comments on the
proposal to include data on the
utilization of drugs and biologicals
furnished in ESRD facilities located in
the Pacific Rim when comparing
utilization of drugs and biologicals in
CY 2007 with CY 2012.
iii. Pricing of ESRD-Related Drugs and
Biologicals
As we stated above, we are proposing
to price ESRD-related drugs and
biologicals to CY 2014 to allow for an
accurate comparison between utilization
of those drugs and biologicals furnished
in CY 2007 with utilization in CY 2012.
In order to price ESRD-related drugs and
biologicals based on CY 2014 prices, we
started with CY 2011 prices as
established and published in the CY
2011 ESRD PPS final rule.
During the development of the ESRD
PPS base rate, we included the MAP
amounts for ESRD-related drugs and
biologicals that were, prior to January 1,
PO 00000
Frm 00008
Fmt 4701
Sfmt 4702
2011, separately paid under Part B. For
setting the CY 2011 ESRD PPS base rate,
for Part B separately billable drugs, we
used the first two quarters of ASP+6 and
then used the Producer Price Index (PPI)
to inflate the prices to CY 2011 (75 FR
49079). We also included the MAP
amounts for the ESRD-related oralequivalent drugs and biologicals that
were, prior to January 1, 2011,
separately paid under Part D (75 FR
49080). For setting the CY 2011 ESRD
PPS base rate for these drugs, we used
the growth rates for overall prescription
drug prices that were used in the
National Health Expenditure Projections
(NHE) for updating prices for former
Part D drugs to CY 2011 from CY 2007.
We propose to inflate the prices
established in the CY 2011 ESRD PPS
final rule for ESRD-related drugs and
biologicals and their oral equivalents to
CY 2014 by applying the ESRD bundled
(ESRDB) market basket, the productivity
adjustment, and the wage index budget
neutrality adjustment factors. Because
the base rate and the ESRDB market
basket account for ESRD-related drugs
and biologicals, and we have updated
all components of the base rate annually
using a market basket minus
productivity with wage index budget
neutrality adjustment factor, we believe
that using these inflation factors are
consistent with how these services are
paid under the ESRD PPS. The drug
component of the ESRDB market basket
uses the PPI for prescription drugs as a
proxy for the growth in drug prices. We
believe using the ESRDB market basket
to price drugs and biologicals for CY
2014 complies with the requirement in
section 1881(b)(14)(I) that the Secretary
take into account the changes in prices
for drugs and biologicals reflected in the
ESRDB market basket percentage
increase factor. The ESRDB market
basket minus productivity increase
factors were 2.1 percent and 2.3 percent
for CY 2012 and CY 2013, respectively.
The proposed CY 2014 update is 2.5
percent. The wage index budget
neutrality adjustment factors for the
same years are 1.001520, 1.000613, and
a proposed factor of 1.000411.
Therefore, we propose to use a total
growth update factor of 7.3 percent
(1.021*1.023*1.025*1.001520*
1.000613*1.000411 = 1.073) to inflate
prices for ESRD-related drugs and
biologicals from CY 2011 levels to CY
2014 levels. We solicit comments on the
use of the ESRDB market basket
percentage increase factor to inflate
prices for drugs and biologicals to CY
2014 levels.
E:\FR\FM\08JYP2.SGM
08JYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
iv. Calculation of the Amount of the per
Treatment Reduction
We applied the 2014 prices to the CY
2007 and CY 2012 drug and biological
utilization data to calculate aggregate
amounts for each year. For drugs and
biologicals for which we have
utilization data for CY 2012, but that
were not present on CY 2007 claims, we
priced these drugs using the ASP+6
percent price for 2012, which is an
average of the four quarter prices, and
inflated it using the CY 2013 and the CY
2014 proposed ESRDB market basket,
productivity, and wage index budget
neutrality adjustment factors. While
most of these drugs had minimal
utilization, we note that Feraheme was
the only significant exception.
Specifically, Feraheme was not
available until January 2010 and once
the drug was available, the use of the
drug rose to the top 12th drug furnished
to ESRD beneficiaries. Next, we divided
each year’s estimated aggregate amount
for drugs and biologicals by that year’s
count of treatments furnished to
Medicare beneficiaries to get an average
payment per treatment for the year. This
resulted in a per treatment amount for
drugs and biologicals of $83.76 in 2007
and a per treatment amount for drugs
and biologicals of $51.42 in 2012. We
then subtracted the average payment per
treatment for CY 2012 from the average
amount per treatment for CY 2007 to get
a total of $32.34 ($83.76¥$51.42 =
$32.34). We then reduced this amount
by the standardization, the outlier, and
the 98 percent budget neutrality
adjustments to get a total of $29.52
($32.34 × .9407 × .99 × .98 = $29.52). We
would apply these adjustments before
reducing the base rate because the base
rate was reduced by these adjustments
when it was first established, and the
reduction should be adjusted in the
same way to make the two figures
comparable. We would then reduce the
CY 2014 proposed base rate of $246.47
by $29.52, resulting in the CY 2014
proposed base rate of $216.95. A
reduction of $29.52 from the proposed
CY 2014 ESRD PPS base rate results in
a 12 percent reduction in Medicare
payments. We solicit comments on the
proposed methodology for the reduction
to the ESRD PPS base rate to reflect the
change in the utilization of ESRDrelated drugs and biologicals from CY
2007 to CY 2012.
While we propose to implement the
full reduction in CY 2014, we note that
we are also concerned that this one-time
reduction to the ESRD PPS base rate
could be a significant reduction to ESRD
facilities for the year and potentially
impact beneficiary access to care.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
Therefore, we are soliciting comments
on a potential transition or phase-in
period of the 12 percent reduction and
the number of years for such transition
or phase-in period.
v. Comparison of ASP Versus PPI
Section 1881(b)(14)(I) requires the
Secretary to ‘‘take into account the most
recently available data on average sales
prices and changes in prices for drugs
and biologicals reflected in the ESRDB
market basket percentage increase
factor’’ in making the reduction to the
ESRD PPS base rate to reflect the change
in utilization of ESRD-related drugs and
biologicals from CY 2007 to CY 2012.
While we could have chosen to inflate
prices for drugs and biologicals to 2014
levels with more recently available ASP
data, we believe using a growth based
on the ESRDB market basket is more
appropriate because it reflects what
Medicare is required to pay for the
drugs and biologicals through the ESRD
PPS base rate. We performed an
alternative analysis using prices based
on the first quarter 2013 ASP+6 percent
prices and the National Drug Code
(NDC) prices published on the CMS
Web site located at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/ESRDpayment/
Outlier_Services.html that are used for
outlier calculations, and the PPI to
project to CY 2014. The results are
minimally different (a difference of
$29.40 versus $29.52), and we believe
that the ESRDB market basket approach
is a more appropriate measure of how
Medicare pays for these drugs under the
ESRD PPS.
We are soliciting comments on the
potential use of ASP instead of the
ESRDB market basket to inflate drug
prices to 2014 levels for purposes of the
drug utilization adjustment.
3. ESRD Bundled Market Basket
a. Overview and Background
In accordance with section
1881(b)(14)(F)(i) of the Act, as added by
section 153(b) of MIPPA and amended
by section 3401(h) of the Affordable
Care Act, beginning in 2012, the ESRD
payment amounts are required to be
annually increased by an ESRD market
basket increase factor that is reduced by
the productivity adjustment described
in section 1886(b)(3)(B)(xi)(II) of the
Act. The application of the productivity
adjustment described may result in the
increase factor being less than 0.0 for a
year and may result in payment rates for
a year being less than the payment rates
for the preceding year. The statute also
provides that the market basket increase
factor should reflect the changes over
PO 00000
Frm 00009
Fmt 4701
Sfmt 4702
40843
time in the prices of an appropriate mix
of goods and services used to furnish
renal dialysis services.
b. Proposed Market Basket Update
Increase Factor and Labor-Related Share
for ESRD Facilities for CY 2014
As required under section
1881(b)(14)(F)(i) of the Act, CMS
developed an all-inclusive ESRDB input
price index (75 FR 49151 through
49162). Although ‘‘market basket’’
technically describes the mix of goods
and services used for ESRD treatment,
this term is also commonly used to
denote the input price index (that is,
cost categories, their respective weights,
and price proxies combined) derived
from a market basket. Accordingly, the
term ‘‘ESRDB market basket,’’ as used in
this document, refers to the ESRDB
input price index.
For this proposed rule, we propose to
use the same methodology and the CY
2008-based ESRDB market basket
described in the CY 2011 ESRD PPS
final rule (75 FR 49151 through 49162)
to compute the CY 2014 ESRDB market
basket increase factor and labor-related
share based on the best available data.
Consistent with historical practice, we
estimate the ESRDB market basket
update based on IHS Global Insight
(IGI), Inc.’s forecast using the most
recently available data. IGI is a
nationally recognized economic and
financial forecasting firm that contracts
with CMS to forecast the components of
the market baskets.
Using this methodology and the IGI
forecast for the first quarter of 2013 of
the CY 2008-based ESRDB market
basket (with historical data through the
fourth quarter of 2012), and consistent
with our historical practice of
estimating market basket increases
based on the best available data, the
proposed CY 2014 ESRDB market basket
increase factor is 2.9 percent.
For the CY 2014 ESRD payment
update, we propose to continue using a
labor-related share of 41.737 percent for
the ESRD PPS payment, which was
finalized in the CY 2011 ESRD final rule
(75 FR 49161).
c. Proposed Productivity Adjustment
Under section 1881(b)(14)(F)(i) of the
Act, as amended by section 3401(h) of
the Affordable Care Act, for CY 2012
and each subsequent year, the ESRD
market basket percentage increase factor
shall be reduced by the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act. The
statute defines the productivity
adjustment as equal to the 10-year
moving average of changes in annual
economy-wide private nonfarm business
E:\FR\FM\08JYP2.SGM
08JYP2
40844
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
multifactor productivity (MFP) (as
projected by the Secretary for the 10year period ending with the applicable
fiscal year, year, cost reporting period,
or other annual period) (the ‘‘MFP
adjustment’’). The Bureau of Labor
Statistics (BLS) is the agency that
publishes the official measure of private
nonfarm business MFP. Please see
https://www.bls.gov/mfp to obtain the
BLS historical published MFP data.
CMS notes that the proposed and final
methodology for calculating and
applying the MFP adjustment to the
ESRD payment update is similar to the
methodology used in other payment
systems, as required by section 3401 of
the Affordable Care Act.
The projection of MFP is currently
produced by IGI. The details regarding
the methodology for forecasting MFP
and how it is applied to the market
basket were finalized in the CY 2012
ESRD PPS final rule (76 FR 70232
through 70234). Using this method and
the IGI forecast for the first quarter of
2013 of the 10-year moving average of
MFP, the proposed CY 2014 MFP factor
is 0.4 percent.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
d. Calculation of the ESRDB Market
Basket Update, Adjusted for Multifactor
Productivity for CY 2014
Under section 1881(b)(14)(F) of the
Act, beginning in CY 2012, ESRD PPS
payment amounts shall be annually
increased by an ESRD market basket
percentage increase factor reduced by
the productivity adjustment. We are
proposing to use the same methodology
for calculating the ESRDB market basket
updates adjusted for MFP that was
finalized in the CY 2012 ESRD PPS final
rule (76 FR 70234).
Thus, in accordance with section
1881(b)(14)(F)(i) of the Act, the
proposed ESRDB market basket
percentage increase factor for CY 2014
is based on the 1st quarter 2013 forecast
of the CY 2008-based ESRDB market
basket, which is estimated to be 2.9
percent. This market basket percentage
is then reduced by the MFP adjustment
(the 10-year moving average of MFP for
the period ending CY 2014) of 0.4
percent, which is based on IGI’s 1st
quarter 2013 forecast. The resulting
proposed MFP-adjusted ESRDB market
basket update for CY 2014 is equal to
2.5 percent, or 2.9 percent less 0.4
percentage point. If more recent data is
subsequently available (for example, a
more recent estimate of the market
basket or MFP adjustment), we will use
such data, if appropriate, to determine
the CY 2014 market basket update and
MFP adjustment in the CY 2014 ESRD
PPS final rule.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
4. The Proposed CY 2014 Wage Index
Section 1881(b)(14)(D)(iv)(II) of the
Act provides that the ESRD PPS may
include a geographic wage index
payment adjustment, such as the index
referred to in section 1881(b)(12)(D) of
the Act. In the CY 2011 ESRD PPS final
rule (75 FR 49117), we finalized the use
of the Office of Management and
Budget’s (OMB) Core-Based Statistical
Areas (CBSAs)-based geographic area
designations to define urban and rural
areas and their corresponding wage
index values. In the CY 2012 ESRD PPS
final rule (76 FR 70239) we finalized
that, under the ESRD PPS, we will
continue to utilize the ESRD PPS wage
index methodology, first established
under the basic case-mix adjusted
composite rate payment system, for
updating the wage index values using
the OMB’s CBSA-based geographic area
designations to define urban and rural
areas and corresponding wage index
values; the gradual reduction of the
wage index floor during the transition;
and the policies for areas with no
hospital data. The CBSA-based
geographic area designations were
originally described in OMB bulletin
03–04, issued June 6, 2003. This
bulletin, as well as subsequent bulletins,
is available online at https://
www.whitehouse,gov/omb/bulletins.
OMB publishes bulletins regarding
CBSA changes, including changes to
CBSA numbers and titles. In accordance
with our established methodology, we
have historically adopted any CBSA
changes that are published in the OMB
bulletin that corresponds with the IPPS
hospital wage index. For FY 2014, we
use the FY 2013 pre-floor, prereclassified hospital wage index to
adjust the ESRD PPS payments. On
February 28, 2013, OMB issued OMB
Bulletin No. 13–01, which establishes
revised delineations of statistical areas
based on OMB standards published in
the Federal Register on June 28, 2010
and 2010 Census Bureau data. Because
the FY 2013 pre-floor, pre-reclassified
hospital wage index was finalized prior
to the issuance of this Bulletin, the FY
2013 pre-floor, pre-reclassified hospital
wage index does not reflect OMB’s new
area delineations based on the 2010
Census and, thus, the FY 2014 ESRD
PPS wage index will not reflect the
OMB changes. As stated in the FY 2014
IPPS/LTCH PPS proposed rule, CMS
intends to propose changes to the
hospital wage index based on this OMB
Bulletin in the FY 2015 IPPS/LTCH PPS
proposed rule (78 FR 27486 (May 10,
2013)). Therefore, we anticipate that the
OMB Bulletin changes will be reflected
in the FY 2015 hospital wage index.
PO 00000
Frm 00010
Fmt 4701
Sfmt 4702
Because we base the ESRD PPS wage
index on the hospital wage index from
the prior year, we anticipate that the
OMB Bulletin changes would be
reflected in the CY 2015 ESRD PPS
wage index.
For CY 2014, we will continue to use
the same methodology as finalized in
the CY 2011 ESRD PPS final rule (75 FR
49117), for determining the wage
indices for ESRD facilities in CY 2014.
Specifically, we propose to adjust wage
indices for CY 2014 to account for
annually updated wage levels in areas
in which ESRD facilities are located. We
propose to use the most recent, FY 2014
inpatient prospective payment system
(IPPS) pre-floor, pre-reclassified
hospital wage index. The ESRD PPS
wage index values are calculated
without regard to geographic
reclassifications authorized under
section 1886(d)(8) and (d)(10) of the Act
and utilize pre-floor hospital data that
are unadjusted for occupational mix.
The proposed CY 2014 wage index
values for urban areas are listed in
Addendum A (Wage Indices for Urban
Areas) and the proposed CY 2014 wage
index values for rural areas are listed in
Addendum B (Wage Indices for Rural
Areas). Addenda A and B are located on
the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ESRDpayment/
End-Stage-Renal-Disease-ESRDPayment-Regulations-and-Notices.html.
In the CY 2011 ESRD PPS final rule
(75 FR 49117), we finalized a policy to
use the labor-related share of 41.737 for
the ESRD PPS portion of the payment.
For the CY 2014 ESRD PPS we are not
proposing any changes to the laborrelated share of 41.737. Because all
providers that elected to participate in
the transition are entering their fourth
year of the transition and will begin
being paid 100 percent under the ESRD
PPS, the 53.711 labor-related share that
was applied to the composite rate
portion of the blended payment is no
longer applicable. We discuss the
methodology for the ESRD PPS laborrelated share in our CY 2011 ESRD PPS
final rule (75 FR 49161), where we note
that the labor-related share is typically
the sum of Wages and Salaries, Benefits,
Housekeeping and Operations,
Professional Fees, Labor-related
Services, and a portion of the Capitalrelated Building and Equipment
expenses. For additional discussions on
the labor-related share please refer to
section II.B.3.b. of this proposed rule.
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
a. Payment under the ESRD PPS for
Facilities Located in Guam, American
Samoa, and the Northern Mariana
Islands and Proposed Wage Index Value
for Guam
It came to our attention after the ESRD
PPS was implemented that ESRD
facilities located in the United States
Territories of Guam, American Samoa
and the Northern Mariana Islands (the
Pacific Rim) have been paid on the basis
of reasonable costs and charges, rather
than under the ESRD PPS. Because
section 1881(b)(14)(A)(i) of the Act
requires the Secretary to implement a
payment system under which a single
payment is made to a renal dialysis
facility for renal dialysis services in lieu
of any other payment for services
furnished on or after January 1, 2011,
ESRD facilities located in the Pacific
Rim must be paid under the ESRD PPS
and will be paid under this system
beginning for services furnished on or
after January 1, 2014. In order to pay
these facilities under the ESRD PPS, we
must identify an appropriate wage index
value for these areas as required under
§ 413.231 of the regulations. We propose
to use the current value calculated
under the existing methodology, that is,
the pre-floor, pre-reclassification,
hospital wage data that is unadjusted for
occupational mix for the island of Guam
of 0.9611, which is displayed in
Addendum B (Wage Indices for Rural
Areas). In addition, the most recent
proposed FY 2014 IPPS pre-floor, prereclassified hospital wage data does not
include wage data for American Samoa
and the Northern Mariana Islands.
Accordingly, we propose below to apply
the wage index value for Guam to
facilities located in American Samoa
and the Northern Mariana Islands.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
b. Proposed Policies for Areas with No
Wage Data
In the CY 2011 ESRD PPS final rule
(75 FR 49117), we finalized the use of
the CBSA-based geographic area
designations to define urban/rural areas
and corresponding wage index values
for the ESRD PPS. In that final rule (75
FR 49116 through 49117), we also
discussed and finalized the
methodologies we use to calculate wage
index values for ESRD facilities that are
located in urban and rural areas where
there is no hospital data. For urban
areas with no hospital data, we compute
the average wage index value of all
urban areas within the State and use
that value as the wage index. For rural
areas with no hospital data, we compute
the wage index using the average wage
index values from all contiguous CBSAs
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
to represent a reasonable proxy for that
rural area.
In the case of American Samoa and
the Northern Mariana Islands, we
believe that Guam represents a
reasonable proxy because the islands are
located within the Pacific Rim and share
a common status as United States
Territories. In addition, the Northern
Mariana Islands and American Samoa
are rural areas with no hospital data.
Therefore, we will use our established
methodology to compute an appropriate
wage index using the average wage
index values from contiguous CBSAs, to
represent a reasonable proxy. While we
appreciate that the islands of the Pacific
Rim are not actually contiguous, we
believe that same principle applies here,
and that Guam is a reasonable proxy for
American Samoa and the Northern
Marianas. We note that if hospital data
becomes available for any of the islands
of the Pacific Rim we will use that data
for the appropriate CBSA’s instead of
the proxy. As discussed previously, the
current wage index value using the
existing methodology for Guam is
0.9611. Therefore, for CY 2014, we
propose to apply this wage index value
of 0.9611 to ESRD facilities located in
America Samoa and the Northern
Mariana Islands, which we are
including in Addendum B.
For CY 2014, the only urban area
without wage index data is HinesvilleFort Stewart, GA. As we discussed in
our CY 2013 ESRD PPS (77 FR 67459),
we will continue to use the statewide
urban average based on the average of
all urban areas within the state for urban
areas without hospital data. For CY
2014 the wage index value for CBSA
#11 (Georgia) is 0.7482 and this is
included in Addendum A. Accordingly,
we propose to apply the statewide urban
average wage index value of 0.7582 to
Hinesville-Fort Stewart, GA.
c. Proposed Reduction to the ESRD
Wage Index Floor
A wage index floor value has been
used in lieu of the calculated wage
index values below the floor in making
payment for renal dialysis services
under the ESRD PPS. In the CY 2011
ESRD PPS final rule (75 FR 49116
through 49117), we finalized that we
would continue to reduce the wage
index floor by 0.05 for each of the
remaining years of the transition. We
further specified in the CY 2012 ESRD
PPS (76 FR 70241) that we finalized the
0.05 reduction to the wage index floor
for CYs 2012 and 2013, resulting in a
wage index floor of 0.550 and 0.500,
respectively.
Our intention has been to provide a
wage index floor only through the 4-
PO 00000
Frm 00011
Fmt 4701
Sfmt 4702
40845
year transition to 100 percent
implementation of the ERSD PPS (75 FR
49116 through 49117; 76 FR 70240
through 70241). Most recently, in the
CY 2013 ESRD PPS final rule (77 FR
67459 through 67461), we discussed the
elimination of the wage index floor
beginning in CY 2014, noting that we
would propose a new methodology in
CY 2014 to address wages in rural
Puerto Rico because we would no longer
be applying a wage index floor. The CY
2014 wage index values for both urban
and rural Puerto Rico remain below the
finalized CY 2013 ESRD PPS wage
index floor of 0.500 (77 FR 67459),
however, and we believe that both rural
and urban facilities in Puerto Rico
would benefit from continuing the
gradual reduction of the floor. We
believe that continuing the wage index
floor for CY 2014 and CY 2015 will
allow renal dialysis facilities located in
Puerto Rico the benefit afforded to other
geographical areas in the fifty states of
a gradual and systematic elimination of
the wage index floor. Therefore, for CY
2014 and for CY 2015, we propose to
continue to apply the wage index floor
to areas with wage indexes below the
floor. For CY 2014, Puerto Rico is the
only area with a wage index value
below the proposed floor; however, to
the extent that other geographical areas
fall below the floor in CY 2015 or
beyond we believe they should have the
benefit of a gradual reduction in the
floor as well. We will continue to
review wage index values and the
appropriateness of a wage index floor in
the future.
For CY 2014 and CY 2015, we also
propose to continue our policy of
gradually reducing the wage index floor
by 0.05 per year. Specifically, we
propose a wage index floor value of 0.45
for CY 2014 and a wage index floor
value of 0.40 for CY 2015. We believe
that continuing our policy of applying a
wage index floor for an additional two
years would allow Puerto Rico to benefit
from the anticipated and predictable
phase out of the wage index floor. While
we would not expect to continue this
policy past CY 2015, we will review the
appropriateness of a wage index floor
for CY 2016 at that time.
d. Proposed Wage Index BudgetNeutrality Adjustment
Section 1881(b)(14)(D)(iv)(II) of the
Act gives us broad discretion to
implement payment adjustments to the
ESRD PPS, including an adjustment of
the ESRD PPS by a geographic index.
Section 1881(b)(14)(D)(iv)(II)
specifically refers to section
1881(b)(12)(D) as an example of such a
geographic index, and in the CY 2011
E:\FR\FM\08JYP2.SGM
08JYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
40846
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
ESRD PPS final rule, we finalized the
use of the same wage index
methodology that we utilized under the
basic case-mix adjusted composite rate
payment system (75 FR 49116). We had
applied a wage index budget-neutrality
adjustment factor under the basic casemix adjusted composite payment
system, and accordingly, in the CY 2012
ESRD PPS final rule, we finalized a
policy for CY 2012 and future years to
apply wage index budget-neutrality
adjustment factors to the composite rate
portion of the ESRD PPS blended
payments for facilities participating in
the transition as well as to the base rate
for the ESRD PPS portion of the blended
payment and the full ESRD PPS for
those facilities that elected to receive
100 percent of their payment under that
system (76 FR 70241 and 70242). We
also finalized the methodology for
computing the wage index budgetneutrality adjustment factors for CY
2012 and subsequent years (76 FR
70242).
For CY 2014, we are not proposing
any changes to the methodology, but we
note that we will no longer compute a
budget neutrality adjustment factor for
the composite rate portion of the ESRD
PPS blended payment because all
facilities will be paid 100 percent under
the ESRD PPS in CY 2014. For ease of
reference, we explain the methodology
for computing the budget-neutrality
adjustment factor here. For the CY 2014
wage index budget-neutrality
adjustment factor, we use the fiscal year
(FY) 2014 pre-floor, pre-reclassified,
non-occupational mix-adjusted hospital
data to compute the wage index values,
2012 outpatient claims (paid and
processed as of December 31, 2012), and
geographic location information for each
facility, which may be found through
Dialysis Facility Compare. Dialysis
Facility Compare (DFC) can be found at
the DFC Web page on the CMS Web site
at https://www.medicare.gov/
dialysisfacilitycompare/. The FY 2014
hospital wage index data for each urban
and rural locale by CBSA may also be
accessed on the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/
index.html?redirect=/
AcuteInpatientPPS/WIFN/list.asp. The
wage index data are located in the
section entitled, ‘‘FY 2014 Proposed
Rule Occupational Mix Adjusted and
Unadjusted Average Hourly Wage and
Pre-Reclassified Wage Index by CBSA’’.
We computed the proposed CY 2014
wage index budget-neutrality
adjustment factor using treatment
counts from the 2012 claims and
facility-specific CY 2013 payment rates
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
to estimate the total dollar amount that
each ESRD facility would have received
in CY 2013. The total of these payments
became the target amount of
expenditures for all ESRD facilities for
CY 2014. Next, we computed the
estimated dollar amount that would
have been paid for the same ESRD
facilities using the proposed ESRD wage
index for CY 2014. The total of these
payments becomes the new CY 2014
amount of wage-adjusted expenditures
for all ESRD facilities. The wage index
budget-neutrality factor is calculated as
the target amount divided by the new
CY 2014 amount. When we multiplied
the wage index budget-neutrality factor
by the applicable CY 2014 estimated
payments, aggregate payments to ESRD
facilities would remain budget-neutral
when compared to the target amount of
expenditures. That is, the wage index
budget-neutrality adjustment factor
ensures that wage index adjustments do
not increase or decrease aggregate
Medicare payments with respect to
changes in wage index updates.
Therefore, we are proposing a wage
index budget-neutrality adjustment
factor of 1.000411, which would be
computed in ESRD PPS base rate
payment methodology when making
payment for renal dialysis services in
CY 2014.
5. Application of the International
Classification of Diseases (ICD), Tenth
Revision, to the Comorbidity Payment
Adjustment Codes
In the CY 2011 ESRD PPS final rule
(75 FR 49094), we explained that
section 1881(b)(14)(D)(i) of the Act, as
added by section 153(b) of MIPPA,
requires that the ESRD PPS include a
payment adjustment based on case-mix
that may take into account, among other
things, patient comorbidities.
Comorbidities are specific patient
conditions that coexist with the
patient’s principal diagnosis that
necessitates dialysis. The comorbidity
payment adjustment recognizes the
increased costs associated with
comorbidities and provides additional
payment for certain conditions that
occur concurrently with the need for
dialysis.
To develop the comorbidity payment
adjustment, we used a stepwise
regression model to analyze comorbidity
data and found that certain
comorbidities are predictors of variation
in payments for ESRD patients. Details
on the development of the comorbidity
categories eligible for the comorbidity
payment adjustment, including an
explanation of the stepwise regression
model that we used to analyze
comorbidity data, is discussed in the CY
PO 00000
Frm 00012
Fmt 4701
Sfmt 4702
2011 ESRD PPS final rule (75 FR 49094
through 49108). We analyzed the
comorbidity categories and excluded
those categories from the comorbidity
payment adjustment that met any of
three exclusion criteria (75 FR 49095
through 49100): (1) Inability to create
accurate clinical definitions; (2)
potential for adverse incentives
regarding care; and (3) potential for
ESRD facilities to directly influence the
prevalence of the co-morbidity either by
altering dialysis care, changing
diagnostic testing patterns, or
liberalizing the diagnostic criteria.
We finalized six comorbidity
categories eligible for the comorbidity
payment adjustment, each with
associated International Classification of
Disease, 9th Revision, Clinical
Modification (ICD–9–CM) diagnosis
codes (75 FR 49100). Among these
categories are three acute, short-term
diagnostic categories (pericarditis,
bacterial pneumonia, and
gastrointestinal tract bleeding with
hemorrhage) and three chronic
diagnostic categories (hereditary
hemolytic anemia with sickle cell
anemia, myelodysplastic syndrome, and
monoclonal gammopathy). The
comorbidity categories eligible for the
adjustment and their associated ICD–9–
CM codes were published in the
Appendix of the CY 2011 ESRD PPS
final rule as Table E: ICD–9–CM Codes
Recognized for a Comorbidity Payment
Adjustment (75 FR 49211).
In the CY 2012 ESRD PPS final rule
(76 FR 70252), we clarified that the
ICD–9–CM codes eligible for the
comorbidity payment adjustment are
subject to the annual ICD–9–CM coding
updates that occur in the hospital
inpatient PPS final rule and are effective
October 1st of every year. We explained
that any updates to the ICD–9–CM codes
that affect the categories of
comorbidities and the diagnoses within
the comorbidity categories that are
eligible for the comorbidity payment
adjustment would be communicated to
ESRD facilities through sub-regulatory
guidance. Accordingly, Change Request
(CR) 7476, Transmittal 2255, entitled,
‘‘Quarterly Update to the End-Stage
Renal Disease Prospective Payment
System, was issued on July 15, 2011 to
update the ICD–9–CM codes eligible for
the comorbidity payment adjustment in
accordance with the annual ICD–9–CM
update effective October 1, 2011. This
CR can be found on the CMS Web site
at the following link: https://
www.cms.gov/Regulations-andGuidance/Guidance/Transmittals/
Downloads/R2255CP.pdf. There have
not been updates to the ICD–9–CM
codes eligible for the comorbidity
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
payment adjustment since October 1,
2011.
Effective October 1, 2014, CMS will
implement the 10th revision of the ICD
coding scheme—ICD–10–CM. Because
the transition to ICD–10–CM coding will
occur during CY 2014, we discuss here
the crosswalk from ICD–9–CM to ICD–
10–CM codes for the purpose of
determining eligibility for the
comorbidity payment adjustment.
We crosswalked the ICD–9–CM codes
that are eligible for the comorbidity
payment adjustment to ICD–10–CM
codes using the General Equivalence
Mappings (GEM) tool, which is the
authoritative source for crosswalking
developed by the National Center for
Health Statistics and CMS. The
crosswalk from ICD–9–CM to ICD–10–
CM diagnosis codes resulted in three
scenarios: One ICD–9–CM code could
crosswalk to one ICD–10–CM code; one
ICD–9–CM code crosswalked to
multiple ICD–10–CM codes; or multiple
ICD–9–CM crosswalked to one ICD–10–
CM code. We applied the three
exclusion criteria listed above to each of
the ICD–10–CM codes to which the
ICD–9–CM codes crosswalked.
In our clinical evaluation, we found
the ICD–9–CM codes generally
crosswalked to one ICD–10–CM code
that codes for the same diagnosis, has
the same code descriptor, and does not
meet any of our exclusion criteria.
Accordingly, with the exceptions noted
below, we propose that ICD–10–CM
codes will be eligible for the
comorbidity payment adjustment where
they crosswalk from ICD–9–CM codes
that are eligible for the comorbidity
payment adjustment. There are,
however, two instances where ICD–9–
CM codes crosswalk to ICD–10–CM
codes that we believe meet one or more
of the exclusion criteria described
above, and we propose to exclude these
codes from eligibility for the
comorbidity payment adjustment.
a. One ICD–9–CM Code Crosswalks to
One ICD–10–CM Code
Table 1 lists all the instances in which
one ICD–9–CM code crosswalks to one
ICD–10–CM code. We propose that all of
those ICD–10–CM codes will be subject
to the comorbidity payment adjustment
with the exception of K52.81
Eosinophilic gastritis or gastroenteritis.
Currently, 535.71 Eosinophilic gastritis
with hemorrhage is one of 40 ICD–9–CM
diagnosis codes under the acute
comorbidity category of Gastrointestinal
(GI) Bleeding. The descriptor of K52.81,
the ICD–10–CM code to which this ICD–
40847
9–CM code crosswalks, does not include
the word ‘‘hemorrhage.’’ In the CY 2011
ESRD PPS final rule (75 FR 49097), we
specifically limited the GI bleeding
category for the comorbidity payment
adjustment to GI bleed with hemorrhage
because we believed that the
gastrointestinal tract bleeding category
met our first exclusion criterion—
inability to create accurate clinical
definitions—because it was overly
broad. We also believed that use of this
diagnosis category could lead to gaming
consistent with the second and third
exclusion criteria listed above. For these
reasons, we limited the gastrointestinal
tract bleeding diagnosis category to
gastrointestinal tract bleeding with
hemorrhage, which we believe creates
accurate clinical definitions and
mitigates the potential for adverse
incentives in ESRD care. Accordingly,
we propose to exclude ICD–10–CM code
K52.81 Eosinophilic gastritis or
gastroenteritis from eligibility for the
comorbidity payment adjustment
because the code descriptor does not
indicate the diagnosis of a hemorrhage.
We propose that all of the other ICD–
10–CM codes listed in the Table 1 below
will be eligible for the comorbidity
payment adjustment.
TABLE 1—ONE ICD–9–CM CODE CROSSWALKS TO ONE ICD–10–CM CODE
ICD–9
Descriptor
ICD–10
Descriptor
Gastrointestinal Bleeding
530.21 ...............
535.71 ...............
537.83 ...............
569.85 ...............
Ulcer of esophagus with bleeding .............................
Eosinophilic gastritis, with hemorrhage .....................
Angiodysplasia of stomach and duodenum with
hemorrhage.
Angiodysplasia of intestine with hemorrhage ...........
K22.11 ..............
K52.81 ..............
K31.811 ............
K55.21 ..............
Ulcer of esophagus with bleeding
Eosinophilic gastritis or gastroenteritis
Angiodysplasia of stomach and duodenum with
bleeding
Angiodysplasia of colon with hemorrhage
Bacterial Pneumonia
003.22 ...............
482.0 .................
482.1 .................
482.2 .................
A02.22 ..............
J15.0 .................
J15.1 .................
J14 ....................
Salmonella pneumonia
Pneumonia due to Klebsiella pneumoniae
Pneumonia due to Pseudomonas
Pneumonia due to Hemophilus influenzae
J15.3 .................
J15.20 ...............
J15.211 .............
482.49 ...............
482.82 ...............
482.83 ...............
Salmonella pneumonia ..............................................
Pneumonia due to Klebsiella pneumonia .................
Pneumonia due to Pseudomonas .............................
Pneumonia due to Hemophilus influenzae [H.
influenzae].
Pneumonia due to Streptococcus, group B ..............
Pneumonia due to Staphylococcus, unspecified ......
Methicillin susceptible pneumonia due to Staphylococcus aureus.
Methicillin resistant pneumonia due to Staphylococcus aureus.
Other Staphylococcus pneumonia ............................
Pneumonia due to escherichia coli [E. coli] ..............
Pneumonia due to other gram-negative bacteria .....
482.84 ...............
507.0 .................
507.8 .................
Pneumonia due to Legionnaires’ disease .................
Pneumonitis due to inhalation of food or vomitus ....
Pneumonitis due to other solids and liquids .............
A48.1 ................
J69.0 .................
J69.8 .................
510.0 .................
510.9 .................
Empyema with fistula ................................................
Empyema without mention of fistula .........................
J86.0 .................
J86.9 .................
Pneumonia due to streptococcus, group B
Pneumonia due to staphylococcus, unspecified
Pneumonia due to Methicillin susceptible Staphylococcus aureus
Pneumonia due to Methicillin resistant Staphylococcus aureus
Pneumonia due to other staphylococcus
Pneumonia due to Escherichia coli
Pneumonia due to other aerobic Gram-negative
bacteria
Legionnaires’ disease
Pneumonitis due to inhalation of food and vomit
Pneumonitis due to inhalation of other solids and
liquids
Pyothorax with fistula
Pyothorax without fistula
482.32 ...............
482.40 ...............
482.41 ...............
tkelley on DSK3SPTVN1PROD with PROPOSALS2
482.42 ...............
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00013
Fmt 4701
J15.212 .............
J15.29 ...............
J15.5 .................
J15.6 .................
Sfmt 4702
E:\FR\FM\08JYP2.SGM
08JYP2
40848
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
TABLE 1—ONE ICD–9–CM CODE CROSSWALKS TO ONE ICD–10–CM CODE—Continued
ICD–9
Descriptor
ICD–10
Descriptor
Pericarditis
420.91 ...............
Acute idiopathic pericarditis ......................................
I30.0 .................
Acute nonspecific idiopathic pericarditis
Hereditary Hemolytic and Sickle Cell Anemia
282.0 .................
282.1 .................
282.41 ...............
282.43 ...............
282.44 ...............
282.45 ...............
282.46 ...............
282.47 ...............
282.49 ...............
282.61 ...............
282.63 ...............
282.68 ...............
Hereditary spherocytosis ...........................................
Hereditary elliptocytosis ............................................
Sickle-cell thalassemia without crisis ........................
Alpha thalassemia .....................................................
Beta thalassemia .......................................................
Delta-beta thalassemia ..............................................
Thalassemia minor ....................................................
Hemoglobin E-beta thalassemia ...............................
Other thalassemia .....................................................
Hb-SS disease without crisis ....................................
Sickle-cell/Hb-C disease without crisis .....................
Other sickle-cell disease without crisis .....................
D58.0 ................
D58.1 ................
D57.40 ..............
D56.0 ................
D56.1 ................
D56.2 ................
D56.3 ................
D56.5 ................
D56.8 ................
D57.1 ................
D57.20 ..............
D57.80 ..............
Hereditary spherocytosis
Hereditary elliptocytosis
Sickle-cell thalassemia without crisis
Alpha thalassemia
Beta thalassemia
Delta-beta thalassemia
Thalassemia minor
Hemoglobin E-beta thalassemia
Other thalassemias
Sickle-cell disease without crisis
Sickle-cell/Hb-C disease without crisis
Other sickle-cell disorders without crisis
Myelodysplastic Syndrome
238.7 .................
238.73 ...............
238.74 ...............
Essential thrombocythemia .......................................
High grade myelodysplastic syndrome lesions .........
Myelodysplastic syndrome with 5q deletion ..............
D47.3 ................
D46.22 ..............
D46.C ...............
238.76 ...............
Myelofibrosis with myeloid metaplasia ......................
D47.1 ................
b. One ICD–9–CM Code Crosswalks to
Multiple ICD–10–CM Codes
Table 2 lists all of the instances in
which one ICD–9–CM code crosswalks
to multiple ICD–10–CM codes. In those
instances, we propose that all the
crosswalked ICD–10–CM codes will be
subject to the comorbidity payment
adjustment, with the exception of D89.2
Hypergammaglobulinemia, unspecified.
ICD–9–CM code 273.1 Monoclonal
paraproteinemia is the only ICD–9–CM
code eligible for the comorbidity
payment adjustment under the chronic
comorbidity category of Monoclonal
gammopathy. ICD–9–CM code 273.1
Monoclonal paraproteinemia crosswalks
to two ICD–10–CM codes: D47.2
Monoclonal gammopathy and D89.2
Essential (hemorrhagic) thrombocythemia
Refractory anemia with excess of blasts 2
Myelodysplastic syndrome with isolated del(5q)
chromosomal abnormality
Chronic myeloproliferative disease
Hypergammaglobulinemia, unspecified.
We analyzed both of these ICD–10–CM
codes and determined that D47.2
Monoclonal gammopathy should be
eligible for the comorbidity payment
adjustment because, like ICD–9–CM
code 273.1 Monoclonal
paraproteinemia, it indicates that there
is an excessive amount of a single
monoclonal gammaglobulin. When we
analyzed the comorbidity category for
the CY 2011 ESRD PPS final rule, single
monoclonal gammaglobulin was shown
to have an association with higher
erythropoiesis stimulating agent (ESA)
usage, thereby resulting in higher costs
to dialysis facilities. After clinical
evaluation of D89.2
Hypergammaglobulinemia, unspecified,
however, we determined that this ICD–
10–CM code should not be eligible for
the comorbidity payment adjustment
because D89.2
Hypergammaglobulinemia, unspecified
indicates only that 1 or more
immunoglobulins are elevated, but does
not identify which immunoglobulin(s)
are elevated. We believe that the lack of
specificity of this particular code results
in an inability to create an accurate
clinical definition, which is the first of
the three exclusion criteria.
Accordingly, we propose that D89.2
Hypergammaglobulinemia, unspecified
will not be eligible for the comorbidity
payment adjustment. We propose that
all of the other ICD–10–CM codes listed
in Table 2 below will be eligible for the
comorbidity payment adjustment.
TABLE 2—ONE ICD–9–CM CODE CROSSWALKS TO MULTIPLE ICD–10–CM CODES
ICD–9
Descriptor
ICD–10
Descriptor
Gastrointestinal Bleeding
562 ....................
Diverticulosis of small intestine with hemorrhage .....
K57.11 ..............
K57.51 ..............
tkelley on DSK3SPTVN1PROD with PROPOSALS2
562.03 ...............
Diverticulitis of small intestine with hemorrhage .......
K57.01 ..............
K57.13 ..............
K57.41 ..............
K57.53 ..............
562.12 ...............
VerDate Mar<15>2010
Diverticulosis of colon with hemorrhage ...................
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00014
Fmt 4701
K57.31 ..............
Sfmt 4702
Diverticulosis of small intestine without perforation
or abscess with bleeding.
Diverticulosis of both small and large intestine without perforation or abscess with bleeding.
Diverticulitis of small intestine with perforation and
abscess with bleeding.
Diverticulitis of small intestine without perforation or
abscess with bleeding.
Diverticulitis of both small and large intestine with
perforation and abscess with bleeding.
Diverticulitis of both small and large intestine without perforation or abscess with bleeding.
Diverticulosis of large intestine without perforation
or abscess with bleeding.
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
40849
TABLE 2—ONE ICD–9–CM CODE CROSSWALKS TO MULTIPLE ICD–10–CM CODES—Continued
ICD–9
Descriptor
ICD–10
Descriptor
K57.91 ..............
Diverticulosis of intestine, part unspecified, without
perforation or abscess with bleeding.
Diverticulosis of both small and large intestine without perforation or abscess with bleeding.
Diverticulitis of large intestine with perforation and
abscess with bleeding.
Diverticulitis of large intestine without perforation or
abscess with bleeding.
Diverticulitis of both small and large intestine with
perforation and abscess with bleeding.
Diverticulitis of both small and large intestine without perforation or abscess with bleeding.
K57.51 ..............
562.13 ...............
Diverticulitis of colon with hemorrhage .....................
K57.21 ..............
K57.33 ..............
K57.41 ..............
K57.53 ..............
Bacterial Pneumonia
513.0 .................
Abscess of lung .........................................................
J85.0 .................
J85.1 .................
J85.2 .................
Gangrene and necrosis of lung.
Abscess of lung with pneumonia.
Abscess of lung without pneumonia.
Pericarditis
420.0 .................
Acute pericarditis in diseases classified elsewhere ..
420.90 ...............
Acute pericarditis, unspecified ..................................
420.99 ...............
Other acute pericarditis .............................................
A18.84 ..............
I32 ....................
M32.12 .............
I30.1 .................
I30.9 .................
I30.8 .................
I30.9 .................
Tuberculosis of heart.
Pericarditis in diseases classified elsewhere.
Pericarditis in systemic lupus erythematosus.
Infective pericarditis.
Acute pericarditis, unspecified.
Other forms of acute pericarditis.
Acute pericarditis, unspecified.
Hereditary Hemolytic and sickle cell anemia
282.2 .................
Anemias due to disorders of glutathione metabolism
D55.0 ................
D55.1 ................
282.3 .................
Other hemolytic anemias due to enzyme deficiency
282.42 ...............
Sickle-cell thalassemia with crisis .............................
282.62 ...............
Hb-SS disease with crisis .........................................
282.64 ...............
Sickle-cell/Hb-C disease with crisis ..........................
D55.2 ................
D55.3 ................
D55.8 ................
D55.9 ................
D57.411 ............
D57.412 ............
D57.419 ............
D57.00 ..............
D57.01 ..............
D57.02 ..............
D57.211 ............
Other sickle-cell disease with crisis ..........................
D57.212 ............
D57.219 ............
D57.811 ............
282.69 ...............
D57.812 ............
D57.819 ............
Anemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency.
Anemia due to other disorders of glutathione metabolism.
Anemia due to disorders of glycolytic enzymes.
Anemia due to disorders of nucleotide metabolism.
Other anemias due to enzyme disorders.
Anemia due to enzyme disorder, unspecified.
Sickle-cell thalassemia with acute chest syndrome.
Sickle-cell thalassemia with splenic sequestration.
Sickle-cell thalassemia with crisis, unspecified.
Hb-SS disease with crisis, unspecified.
Hb-SS disease with acute chest syndrome.
Hb-SS disease with splenic sequestration.
Sickle-cell/Hb-C disease with acute chest syndrome.
Sickle-cell/Hb-C disease with splenic sequestration.
Sickle-cell/Hb-C disease with crisis, unspecified.
Other sickle-cell disorders with acute chest syndrome.
Other sickle-cell disorders with splenic sequestration.
Other sickle-cell disorders with crisis, unspecified.
Monoclonal Gammopathy
273.1 .................
Monoclonal paraproteinemia .....................................
D47.2 ................
D89.2 ................
Monoclonal gammopathy.
Hypergammaglobulinemia, unspecified.
Myelodysplastic Syndrome
tkelley on DSK3SPTVN1PROD with PROPOSALS2
238.72 ...............
Low grade myelodysplastic syndrome lesions ..........
D46.0 ................
D46.1 ................
D46.20 ..............
D46.21 ..............
D46.4 ................
D46.A ................
D46.B ................
238.75 ...............
VerDate Mar<15>2010
Myelodysplastic syndrome, unspecified ....................
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00015
Fmt 4701
D46.9 ................
Sfmt 4702
Refractory anemia without ring sideroblasts, so stated.
Refractory anemia with ring sideroblasts.
Refractory anemia with excess of blasts, unspecified.
Refractory anemia with excess of blasts 1.
Refractory anemia, unspecified.
Refractory cytopenia with multilineage dysplasia.
Refractory cytopenia with multilineage dysplasia
and ring sideroblasts.
Myelodysplastic syndrome, unspecified.
E:\FR\FM\08JYP2.SGM
08JYP2
40850
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
TABLE 2—ONE ICD–9–CM CODE CROSSWALKS TO MULTIPLE ICD–10–CM CODES—Continued
ICD–9
Descriptor
ICD–10
D46.Z ................
c. Multiple ICD–9–CM Codes Crosswalk
to One ICD–10–CM Code
Table 3 displays the crosswalk where
multiple ICD–9–CM codes crosswalk to
Descriptor
Other myelodysplastic syndromes.
one ICD–10–CM code. For the reasons
explained above, we propose that all of
the crosswalked ICD–10–CM codes
listed below will be eligible for the
comorbidity payment adjustment.
TABLE 3—MULTIPLE ICD–9–CM CODES CROSSWALK TO ONE ICD–10–CM CODE
ICD–9
Descriptor
ICD–10
Descriptor
Gastrointestinal Bleeding
533.20 ...............
533.21 ...............
533.40 ...............
533.41 ...............
533.60 ...............
533.61 ...............
534.00 ...............
534.01 ...............
534.20 ...............
534.21 ...............
534.40 ...............
534.41 ...............
534.60 ...............
534.61 ...............
Acute peptic ulcer of unspecified site with hemorrhage and perforation, without mention of obstruction.
Acute peptic ulcer of unspecified site with hemorrhage and perforation, with obstruction.
Chronic or unspecified peptic ulcer of unspecified
site with hemorrhage, without mention of obstruction.
Chronic or unspecified peptic ulcer of unspecified
site with hemorrhage, with obstruction.
Chronic or unspecified peptic ulcer of unspecified
site with hemorrhage and perforation, without
mention of obstruction.
Chronic or unspecified peptic ulcer of unspecified
site with hemorrhage and perforation, with obstruction.
Acute gastrojejunal ulcer with hemorrhage, without
mention of obstruction.
Acute gastrojejunal ulcer, with hemorrhage, with obstruction.
Acute gastrojejunal ulcer with hemorrhage and perforation, without mention of obstruction.
Acute gastrojejunal ulcer with hemorrhage and perforation, with obstruction.
Chronic or unspecified gastrojejunal ulcer with hemorrhage, without mention of obstruction.
Chronic or unspecified gastrojejunal ulcer, with
hemorrhage, with obstruction.
Chronic or unspecified gastrojejunal ulcer with hemorrhage and perforation, without mention of obstruction.
Chronic or unspecified gastrojejunal ulcer with hemorrhage and perforation, with obstruction.
K27.2 ................
Acute peptic ulcer, site unspecified, with both hemorrhage and perforation.
K27.4 ................
Chronic or unspecified peptic ulcer, site unspecified,
with hemorrhage.
K27.6 ................
Chronic or unspecified peptic ulcer, site unspecified,
with both hemorrhage and perforation.
K28.0 ................
Acute gastrojejunal ulcer with hemorrhage.
K28.2 ................
Acute gastrojejunal ulcer with both hemorrhage and
perforation.
K28.4 ................
Chronic or unspecified gastrojejunal ulcer with hemorrhage.
K28.6 ................
Chronic or unspecified gastrojejunal ulcer with both
hemorrhage and perforation.
Bacterial Pneumonia
tkelley on DSK3SPTVN1PROD with PROPOSALS2
482.30
482.31
482.39
482.81
482.89
...............
...............
...............
...............
...............
Pneumonia
Pneumonia
Pneumonia
Pneumonia
Pneumonia
due
due
due
due
due
to
to
to
to
to
Streptococcus, unspecified .........
Streptococcus, group A.
other Streptococcus.
anaerobes ...................................
other specified bacteria.
In summary, based on our clinical
evaluation of the ICD–10–CM codes to
which the eligible ICD–9–CM codes
crosswalk, we propose that both D89.2
Hypergammaglobulinemia, unspecified
and K52.81 Eosinophilic gastritis or
gastroenteritis would not be eligible for
the comorbidity payment adjustment.
We propose that all other ICD–10–CM
codes to which eligible ICD–9–CM
codes crosswalk that are listed in the
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
J15.4 .................
Pneumonia due to other streptococci.
J15.8 .................
Pneumonia due to other specified bacteria.
Tables above will be eligible for the
comorbidity payment adjustment
effective October 1, 2014. We are
soliciting comments on the ICD–10–CM
codes that we propose to exclude and
those we propose will be eligible for the
comorbidity payment adjustment.
PO 00000
Frm 00016
Fmt 4701
Sfmt 4702
6. Proposed Revisions to the Outlier
Policy
Section 1881(b)(14)(D)(ii) of the Act
requires that the ESRD PPS include a
payment adjustment for high cost
outliers due to unusual variations in the
type or amount of medically necessary
care, including variability in the amount
of erythropoiesis stimulating agents
(ESAs) necessary for anemia
management. Our regulations at 42 CFR
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
§ 413.237(a)(1) provide that ESRD
outlier services are the following items
and services that are included in the
ESRD PPS bundle: (i) ESRD-related
drugs and biologicals that were or
would have been, prior to January 1,
2011, separately billable under
Medicare Part B; (ii) ESRD-related
laboratory tests that were or would have
been, prior to January 1, 2011,
separately billable under Medicare Part
B; (iii) medical/surgical supplies,
including syringes, used to administer
ESRD-related drugs, that were or would
have been, prior to January 1, 2011,
separately billable under Medicare Part
B; and (iv) renal dialysis service drugs
that were or would have been, prior to
January 1, 2011, covered under
Medicare Part D, excluding ESRDrelated oral-only drugs.
In the CY 2011 ESRD PPS final rule
(75 FR 49142), we stated that for
purposes of determining whether an
ESRD facility would be eligible for an
outlier payment, it would be necessary
for the facility to identify the actual
ESRD outlier services furnished to the
patient by line item on the monthly
claim. The ESRD-related drugs,
laboratory tests, and medical/surgical
supplies that we would recognize as
outlier services were specified in
Attachment 3 of Change Request 7064,
Transmittal 2033 issued August 20,
2010, rescinded and replaced by
Transmittal 2094, dated November 17,
2010. With respect to the outlier policy,
Transmittal 2094 identified additional
drugs and laboratory tests that may be
eligible for ESRD outlier payment.
Transmittal 2094 was rescinded and
replaced by Transmittal 2134, dated
January 14, 2011, which was issued to
correct the subject on the Transmittal
page and made no other changes.
In the CY 2012 ESRD PPS final rule
(76 FR 70246), we eliminated the
issuance of a specific list of eligible
outlier service drugs which were or
would have been separately billable
under Medicare Part B prior to January
1, 2011. However, we use separate
guidance to continue to identify renal
dialysis service drugs which were or
would have been covered under Part D
for outlier eligibility purposes in order
to provide unit prices for calculating
imputed outlier services. We also can
identify, through our monitoring efforts,
items and services that are incorrectly
being identified as eligible outlier
services in the claims data. Any updates
to the list of renal dialysis items and
services that qualify as outlier services
are made through administrative
issuances, if necessary.
Our regulations at 42 CFR
§ 413.237(a)(2) through (a)(6), (b), and
(c) specify the methodology used to
calculate outlier payments. An ESRD
facility is eligible for an outlier payment
if its actual or imputed Medicare
Allowable Payment (MAP) amount per
treatment for ESRD outlier services
exceeds a threshold. The MAP amount
represents the average incurred amount
per treatment for services that were or
would have been considered separately
billable services prior to January 1,
2011. The threshold is equal to the
ESRD facility’s predicted ESRD outlier
services MAP amount per treatment
(which is case-mix adjusted) plus the
fixed dollar loss amount. In accordance
with § 413.237(c) of the regulations,
facilities are paid 80 percent of the per
treatment amount by which the imputed
MAP amount for outlier services (that is,
the actual incurred amount) exceeds
this threshold. ESRD facilities are
eligible to receive outlier payments for
treating both adult and pediatric
dialysis patients.
In the CY 2011 ESRD PPS final rule,
using 2007 data, we established the
outlier percentage at 1.0 percent of total
payments (75 FR 49142 through 49143).
We also established the fixed dollar loss
amounts that are added to the predicted
outlier services MAP amounts. The
outlier services MAP amounts and fixed
dollar loss amounts are different for
adult and pediatric patients due to
differences in the utilization of
separately billable services among adult
and pediatric patients (75 FR 49140).
As we explained in the CY 2011 ESRD
PPS final rule (75 FR 49138 and 49139),
the predicted outlier services MAP
amounts for a patient are determined by
multiplying the adjusted average outlier
services MAP amount by the product of
the patient-specific case-mix adjusters
40851
applicable using the outlier services
payment multipliers developed from the
regression analysis to compute the
payment adjustments. The average
outlier services MAP amount per
treatment for CY 2011 was based on
payment amounts reported on 2007
claims and adjusted to reflect projected
prices for 2011. For CY 2012, the outlier
services MAP amounts and fixed dollar
loss amounts were based on 2010 data
(76 FR 70250). Thus, for CYs 2011 and
2012, the MAP and fixed dollar loss
amounts were computed based on preESRD PPS claims data and utilization.
For CY 2013, the outlier services MAP
amounts and fixed dollar loss amounts
were based on 2011 data (77 FR 67464).
Therefore, the outlier thresholds for CY
2013 were based on utilization of ESRDrelated items and services furnished
under the ESRD PPS. Because of the
lower utilization of epoetin and other
outlier services in CY 2011, we lowered
the MAP amounts and fixed dollar loss
amounts for both adult and pediatric
patients for CY 2013 to allow for an
increase in payments for ESRD
beneficiaries requiring higher resources.
a. Impact of Proposed Changes to the
Outlier Policy
For CY 2014, we are not proposing
any changes to the methodology used to
compute the MAP or fixed dollar loss
amounts. Rather, in this proposed rule,
we are updating the outlier services
MAP amounts and fixed dollar loss
amounts to reflect the utilization of
outlier services reported on the 2012
claims using the December 2012 claims
file. Accordingly, for CY 2014, the MAP
and fixed dollar loss amounts are based
on the ESRD PPS claims and utilization.
The impact of this update is shown in
Table 4, which compares the outlier
services MAP amounts and fixed dollar
loss amounts used for the outlier policy
in CY 2013 with the updated estimates
for this proposed rule. The estimates for
the proposed outlier CY 2014 outlier
policy, which are included in Column II
of Table 4, were inflation-adjusted to
reflect projected 2014 prices for outlier
services.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
TABLE 4—OUTLIER POLICY: IMPACT OF USING UPDATED DATA TO DEFINE THE OUTLIER POLICY
Column I
Final outlier policy for CY2013
(based on 2011 data price
inflated to 2013) *
Age
<18
Average outlier services MAP amount per treatment 1 ...................................
Adjustments
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00017
Fmt 4701
Sfmt 4702
Age
>= 18
$38.65
E:\FR\FM\08JYP2.SGM
$61.38
08JYP2
Column II
Proposed outlier policy for
CY2014 (based on 2012 data
price inflated to 2014) *
Age
<18
$38.65
Age
>= 18
$52.45
40852
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
TABLE 4—OUTLIER POLICY: IMPACT OF USING UPDATED DATA TO DEFINE THE OUTLIER POLICY—Continued
Column I
Final outlier policy for CY2013
(based on 2011 data price
inflated to 2013) *
Age
<18
Standardization for outlier services 2 ........................................................
MIPPA reduction .......................................................................................
Adjusted average outlier services MAP amount 3 ....................................
Fixed dollar loss amount that is added to the predicted MAP to determine
the outlier threshold 4 ...................................................................................
Patient months qualifying for outlier payment .................................................
Age
>= 18
Column II
Proposed outlier policy for
CY2014 (based on 2012 data
price inflated to 2014) *
Age
<18
Age
>= 18
1.0927
0.98
$41.39
0.9878
0.98
$59.42
1.0960
0.98
$41.51
0.9893
0.98
$50.85
$47.32
7.6%
$110.22
5.1%
$54.23
6.2%
$94.26
5.1%
tkelley on DSK3SPTVN1PROD with PROPOSALS2
* The outlier services MAP amounts and fixed dollar loss amounts were inflation adjusted to reflect updated prices for outlier services (that is,
2013 prices in Column I and projected 2014 prices in Column II).
1 Excludes patients for whom not all data were available to calculate projected payments under an expanded bundle. The outlier services MAP
amounts are based on 2012 data. The medically unbelievable edits of 400,000 units for EPO and 1,200 mcg for Aranesp that are in place under
the ESA claims monitoring policy were applied.
2 Applied to the average outlier MAP per treatment. Standardization for outlier services is based on existing case mix adjusters for adult and
pediatric patient groups.
3 This is the amount to which the separately billable (SB) payment multipliers are applied to calculate the predicted outlier services MAP for
each patient.
4 The fixed dollar loss amounts were calculated using 2012 data to yield total outlier payments that represent 1% of total projected payments
for the ESRD PPS.
As seen in Table 4, the estimated
fixed dollar loss amount that determines
the 2014 outlier threshold amount for
adults (Column II) is lower than that
used for the 2013 outlier policy
(Column I). The estimated fixed dollar
loss amount that determines the 2014
outlier threshold amount for pediatric
patients (Column II) is higher than that
used for the 2013 outlier policy
(Column I). The main reason for the
reduction for adult patients is that the
lower utilization of epoetin and other
outlier services continued to decline
during the second year of the PPS. This
can be seen by comparing the outlier
service MAP amount per treatment for
adult patients in Column I ($61.38,
which is based on 2011 data) with that
amount in Column II ($52.45, which is
based on 2012 data).
For pediatric patients, there was no
change in the overall average outlier
service MAP amount between 2011 and
2012 ($38.65 per treatment in both
Columns I and II). In addition, there was
a greater tendency in 2012 for a
relatively small percentage of pediatric
patients to account for a
disproportionate share of the total
outlier service MAP amounts. The one
percent target for outlier payments is
therefore expected to be achieved based
on a smaller percentage of pediatric
outlier cases using 2012 data compared
to 2011 data (6.2 percent of pediatric
patient months are expected to qualify
for outlier payments rather than 7.6
percent). These patterns led to the
estimated fixed dollar loss amount for
pediatric patients being higher for the
outlier policy for CY 2014 compared to
the outlier policy for CY 2013.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
Generally, there is a relatively higher
likelihood for pediatric patients that the
outlier threshold may be adjusted to
reflect changes in the distribution of
outlier service MAP amounts. This is
due to the much smaller overall number
of pediatric patients compared to adult
patients, and therefore to the fact that
the outlier threshold for pediatric
patients is calculated based on data for
a much smaller number of pediatric
patients compared to adult patients.
We propose to update the fixed dollar
loss amounts that are added to the
predicted MAP amounts per treatment
to determine the outlier thresholds for
CY 2014 from $110.22 to $94.26 for
adult patients and from $47.32 to $54.23
for pediatric patients compared with CY
2013 amounts. We estimate that the
percentage of patient months qualifying
for outlier payments under the current
policy will be 5.1 percent and 6.2
percent for adult and pediatric patients,
respectively, based on the 2012 data.
The pediatric outlier MAP and fixed
dollar loss amounts continue to be
lower for pediatric patients than adults
due to the continued lower use of
outlier services (primarily reflecting
lower use of epoetin and other
injectable drugs).
b. Outlier Policy Percentage
42 CFR 413.220(b)(4) stipulates that
the per treatment base rate is reduced by
1 percent to account for the proportion
of the estimated total payments under
the ESRD PPS that are outlier payments.
Based on the 2012 claims, outlier
payments represented approximately
0.2 percent of total payments, again
falling short of the 1 percent target due
PO 00000
Frm 00018
Fmt 4701
Sfmt 4702
to the continuing decline in use of
outlier services. Use of 2012 data to
recalibrate the thresholds, which reflect
lower utilization of EPO and other
outlier services, is expected to result in
aggregate outlier payments close to the
1 percent target in CY 2014. We believe
the proposed update to the outlier MAP
and fixed dollar loss amounts for CY
2014 will increase payments for ESRD
beneficiaries requiring higher resource
utilization and come closer to meeting
our 1 percent outlier policy.
We note that recalibration of the fixed
dollar loss amounts in this proposed
rule for CY 2014 outlier payments
results in no change in payments to
ESRD facilities for beneficiaries with
renal dialysis items and services that are
not eligible for outlier payments, but
increases payments to providers for
beneficiaries with renal dialysis items
and services that are eligible for outlier
payments. Therefore, beneficiary coinsurance obligations would also
increase for renal dialysis services
eligible for outlier payments.
C. Discussion of Self-Dialysis and Home
Dialysis Training Add-on Adjustment
and Request for Public Comments
a. Medicare Policy for Self-Dialysis
Training, Home Dialysis Training, and
Retraining
The existing Medicare policy for
furnishing self-dialysis training, home
dialysis training, and retraining was
finalized in our CY 2011 ESRD PPS final
rule (75 FR 49062 through 49064) and
further discussed in the Medicare
Benefits Policy Manual, (Publication
100–02, Chapter 11). Self-dialysis or
home dialysis can only be performed
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
after an ESRD patient has completed an
appropriate course of training. The
scope of training services that a certified
ESRD facility must furnish to ESRD
patients as a condition of coverage is
described at 42 CFR 494.100(a). For
instance, 42 CFR 494.100(a)(2) states
that the training must be conducted by
a registered nurse. For additional
information on the requirements for
ESRD facilities in furnishing dialysis
training, see 42 CFR Part 494, and
additional information regarding home
dialysis training certification, see the
State Operations Manual, which may be
viewed on the Medicare Web site at the
following link: https://www.cms.gov/
Medicare/Provider-Enrollment-andCertification/
GuidanceforLawsAndRegulations/
Dialysis.html.
42 CFR 494.70 (Condition: Patients’
rights) requires that facilities inform
patients (or their representatives) of
their rights and responsibilities when
they begin their treatment and protect
and provide for the exercise of those
rights. Our regulation at 42 CFR
§ 494.70(7) requires a facility to inform
patients about all treatment modalities’
and settings, including but not limited
to transplantation, home dialysis
modalities, and in-facility hemodialysis.
This includes the patient’s right to
receive resource materials for dialysis
modalities not offered by the facility.
We expect that all ESRD facilities
comply with this regulation and furnish
resource information on home
hemodialysis, even if this modality is
not offered by the facility. When ESRD
facilities are certified for home dialysis
training we expect the facility to
provide training throughout the selfdialysis or home dialysis experience (42
CFR 494.100). Self-dialysis or home
dialysis training services and supplies
may include but are not limited to
personnel services; dialysis supplies,
parenteral items used in dialysis,
written training manuals and materials,
and ESRD-related items and services.
We discuss Medicare’s training
policies in Table 5 (Medicare’s Self or
40853
Home Training by Modality) for the
following dialysis modalities:
• Home Hemodialysis Training
• Intermittent Peritoneal Dialysis
Training
• Continuous Ambulatory Peritoneal
Dialysis Training
• Continuous Cycling Peritoneal
Dialysis Training
We would expect that patients who
elect self-dialysis or home dialysis
training will be good candidates for
these modalities and that they will be
successful in completing the method of
training. This includes compliance with
patient assessments as described in 42
CFR 494.80(a)(9) ‘‘Evaluation of the
patient’s abilities, interests, preferences,
and goals, including the desired level of
participation in the dialysis care
process; the preferred modality
(hemodialysis or peritoneal dialysis),
and setting (for example, home dialysis),
and the patients expectations of care
outcomes.’’
TABLE 5—MEDICARE’S SELF OR HOME TRAINING BY MODALITY
Home Hemodialysis (HHD) Training ..................
Intermittent Peritoneal Dialysis (IPD) Training ...
Continuous Ambulatory Peritoneal Dialysis
(CAPD) Training.
Continuous Cycling Peritoneal Dialysis (CCPD)
Training.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
b. Payment Methodology
In our CY 2011 ESRD PPS final rule
(75 FR 49062 through 49064), we stated
that the ESRD PPS base rate alone does
not account for the staffing costs
associated with training treatments
furnished by a registered nurse. Thus,
we finalized the training add-on
payment adjustment, to be added on to
the ESRD PPS base rate, when one-onone self or home dialysis training is
furnished by a nurse, working for a
Medicare-certified training facility, to a
Medicare beneficiary for either
hemodialysis or the peritoneal dialysis
training modalities listed above.
Likewise, we noted in our CY 2012
ESRD PPS final rule (76 FR 70252), that
‘‘ESRD facilities receive a per-treatment
payment that accounts for case-mix,
geographic location, low-volume, and
outlier payment regardless [of whether]
the patient receives dialysis at home or
in the facility, plus the training addon[,]’’ if applicable.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
HHD training is generally furnished in 4 weeks. Medicare will pay the ESRD facility for up to
25 HHD training sessions. In some HHD programs, the dialysis caregiver is trained to perform the dialysis treatment in its entirety and the patient plays a secondary role. In other
programs, the patient performs most of the treatment and is only aided by a helper.
IPD training is generally furnished in 4 weeks. Medicare will pay the ESRD facility for up to 15
PD training sessions. In the IPD program, the patient’s caregiver is usually trained to carry
out the dialysis care. The patient plays a minimal role, as most are unable to perform selfcare dialysis because of other debilitating conditions.
CAPD training is generally furnished in 2 weeks. Medicare will pay the ESRD facility for up to
15 PD training sessions. In CAPD programs both the patient and the caregiver are trained.
CCPD training is generally furnished in 2 weeks. Medicare will pay the ESRD facility for up to
15 PD training sessions. In CCPD programs both the patient and the caregiver are trained.
The add-on payment adjustment is
also for retraining sessions after a
patient or caregiver has completed the
initial training program and if the
patient continues to be an appropriate
candidate for self or home dialysis
modalities. We would expect that most
Medicare beneficiaries receive
retraining sessions when they receive
new equipment, have a change in
caregiver, or modality change. The
ESRD facility may not bill Medicare for
retraining services when they install
home dialysis equipment or furnish
monitoring services. For example, an
ESRD facility nurse may not bill for
retraining sessions when they update a
home dialysis patient’s treatment
record, order monthly supplies, or
instruct the patient on the use of a new
medication for the treatment of
infection. When retraining sessions are
furnished to a patient or caregiver, there
is an expectation that the patient or
caregiver is already knowledgeable of
PO 00000
Frm 00019
Fmt 4701
Sfmt 4702
the elements of home dialysis, and if
additional training is being done for a
change of equipment or a change in
modality, fewer sessions would be
necessary because of the transferability
of certain basic skills for home dialysis.
We discuss our policy for retraining
sessions in the Medicare Benefit Policy
Manual, Publication 100–02, Chapter
11. If a Medicare beneficiary exceeds the
maximum amount of training sessions
based upon their modality, and, if they
continue to be a good candidate for
home modalities, additional training
sessions or retraining sessions may be
paid by Medicare with medical
justification. In such cases, the ESRD
facility must indicate the medical
justification on the claim for the training
or retraining session submitted for
payment. Because the requirement of
medical justification is specific to the
patient’s training needs, circumstances
(such as a change in caregiver), or
condition (change in modality), we
E:\FR\FM\08JYP2.SGM
08JYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
40854
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
would not expect that an ESRD facility
would routinely bill Medicare for
training or retraining sessions on any
patient.
For CY 2011, we finalized the amount
for the training add-on adjustment at
$33.44 per treatment, and noted that
this amount would be added to the
ESRD PPS base rate payment when a
training treatment is furnished by the
ESRD facility. In addition, we noted that
because the training add-on adjustment
is directly related to nursing salaries
and that nursing salaries differ greatly
based on geographic location, we would
adjust the training add-on payment by
the geographic area wage index
applicable to the ESRD facility. (For
further discussions on wage indexes,
please see section II.B.4. of this
proposed rule.) When home dialysis
training sessions are furnished to a
Medicare beneficiary by a Medicarecertified training facility, Medicare will
make the ESRD PPS computed base rate
payment with all applicable
adjustments, and then the separate addon payment for self or home dialysis
training.
In our CY 2013 ESRD final rule (77 FR
67468 through 67469), we addressed
comments on Medicare’s self and home
dialysis training policies under the
ESRD PPS. In that final rule, we stated
that commenters were concerned that
the payment for home dialysis training
is insufficient and does not reflect the
true costs of training and that they
indicated various ranges of time
required for home training in terms of
time per day and number of training
sessions. At that time, we responded to
those comments by confirming that
CMS will continue to monitor and
analyze trends in home dialysis
training, but that we believe our
payment methodology is adequate for
ESRD facilities furnishing training
services.
In this proposed rule we are seeking
comments on the costs associated with
furnishing self or home dialysis
training. We request comments on the
elements of PD vs. HHD training
sessions, specifically the costs of
furnishing such training, the
appropriate number of training sessions,
and the duration of the training
sessions. Lastly, we are also seeking
comments on a ‘‘holdback’’ payment
methodology, which we discussed in
the CY 2011 ESRD PPS final rule (75 FR
49063). Under this methodology, a
portion of the training payments would
be withheld from the ESRD facility until
the ESRD patient demonstrates that they
have successfully transitioned to a home
modality. Specifically, we are seeking
comments on the length of time
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
necessary for a successful transition to
a home dialysis modality and the
percentage of the payment that should
be held back.
D. Delay of Payment for Oral-Only
Drugs Under the ESRD PPS
Section 1881(b)(14)(A)(i) of the Act, as
added by section 153(b) of the Medicare
Improvements for Patients and
Providers Act of 2008 (MIPPA), requires
the Secretary to implement a payment
system under which a single payment is
made to a provider of services or a renal
dialysis facility for ‘‘renal dialysis
services’’ in lieu of any other payment.
Section 1881(b)(14)(B) defines renal
dialysis services, and subclause (iii) of
that section states that these services
include ‘‘other drugs and biologicals
that are furnished to individuals for the
treatment of ESRD and for which
payment was (before the application of
this paragraph) made separately under
this title, and any oral equivalent form
of such drug or biological[.]’’ We
interpreted this provision as including
not only injectable drugs and biologicals
(other than ESAs, which are included
under clause (ii)) used for the treatment
of ESRD, but also all non-injectable
drugs furnished under Title XVIII. We
also concluded that, to the extent ESRDrelated oral-only drugs do not fall
within clause (iii) of the statutory
definition of renal dialysis services,
such drugs would fall under clause (iv),
and constitute other items and services
used for the treatment of ESRD that are
not described in clause (i). Accordingly,
we defined ‘‘renal dialysis services’’ at
42 CFR 413.174 as including, among
other things, ‘‘[o]ther items and services
that are furnished to individuals for the
treatment of ESRD and for which
payment was (prior to January 1, 2011)
made separately under title XVIII of the
Act (including drugs and biologicals
with only an oral form).’’ Although oralonly drugs are included in the
definition of renal dialysis services, in
the CY 2011 ESRD PPS final rule, we
also finalized a policy to delay payment
for these drugs under the PPS until
January 1, 2014 (75 FR 49044). We
stated that there were certain advantages
to delaying the implementation of
payment for oral-only drugs, including
allowing ESRD facilities additional time
to make operational changes and
logistical arrangements in order to
furnish oral-only ESRD-related drugs
and biologicals to their patients.
Accordingly, 42 CFR 413.174(f)(6)
provides that payment to an ESRD
facility for renal dialysis service drugs
and biologicals with only an oral form
is incorporated into the PPS payment
rates effective January 1, 2014.
PO 00000
Frm 00020
Fmt 4701
Sfmt 4702
On January 3, 2013, Congress enacted
the American Taxpayer Relief Act of
2012 (ATRA). Section 632(b) of ATRA
states that the Secretary ‘‘may not
implement the policy under section
413.176(f)(6) of title 42, Code of Federal
Regulations (relating to oral-only ESRDrelated drugs in the ESRD prospective
payment system), prior to January 1,
2016.’’ Accordingly, payment for oralonly drugs will not be made under the
ESRD PPS before January 1, 2016,
instead of on January 1, 2014, which is
the date originally finalized for payment
of ESRD-related oral-only drugs under
the ESRD PPS (75 FR 49044). We
propose to pay for oral-only drugs
consistent with section 632(b) of ATRA
and implement this delay by revising
the effective date for providing payment
for oral-only ESRD-related drugs under
the ESRD PPS at section 42 CFR
413.174(f)(6) from January 1, 2014 to
January 1, 2016.
Because we propose that oral-only
drugs will be included in the ESRD PPS
starting in CY 2016, we also propose to
change the reference to January 1, 2014
in section 42 CFR 413.237(a)(1)(iv) to
January 1, 2016. In the CY 2011 ESRD
PPS final rule (75 FR 49138), we defined
outlier services as including oral-only
drugs effective January 1, 2014. In
addition to modifying the date on which
oral-only drugs will be eligible for
outlier payments, we also propose to
clarify our regulation at 413.237(a)(1)(iv)
by changing the word ‘‘excluding’’ to
‘‘including’’ to make clear that oral-only
drugs are ESRD outlier services for
purposes of the outlier policy effective
January 1, 2016, consistent with the
policy we established in the CY 2011
final rule (75 FR 49138).
III. End-Stage Renal Disease (ESRD)
Quality Incentive Program (QIP)
A. Background
For more than 30 years, monitoring
the quality of care provided to patients
with end-stage renal disease (ESRD) by
dialysis facilities has been an important
component of the Medicare ESRD
payment system. The ESRD quality
incentive program (QIP) is the most
recent step in fostering improved
patient outcomes by establishing
incentives for dialysis facilities to meet
or exceed performance standards
established by CMS. The ESRD QIP is
authorized by section 1881(h) of the
Social Security Act (the Act), which was
added by section 153(c) of Medicare
Improvements for Patients and
Providers Act (MIPPA). CMS
established the ESRD QIP for payment
year (PY) 2012, the initial year of the
program in which payment reductions
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
were applied, in two rules published in
the Federal Register on August 12,
2010, and January 5, 2011 (75 FR 49030
and 76 FR 628, respectively).
Subsequently, on November 10, 2011,
CMS published a rule in the Federal
Register outlining the PY 2013 and PY
2014 ESRD QIP requirements (76 FR
70228). On November 9, 2012, CMS
published a rule in the Federal Register
outlining the ESRD QIP requirements
for PY 2015 and future payment years
(77 FR 67450).
Section 1881(h) of the Act requires
the Secretary to establish an ESRD QIP
by (i) selecting measures; (ii)
establishing the performance standards
that apply to the individual measures;
(iii) specifying a performance period
with respect to a year; (iv) developing a
methodology for assessing the total
performance of each facility based on
the performance standards with respect
to the measures for a performance
period; and (v) applying an appropriate
payment reduction to facilities that do
not meet or exceed the established Total
Performance Score (TPS). This proposed
rule discusses each of these elements
and our proposals for their application
to PY 2016 and future payment years of
the ESRD QIP. As of January 1, 2014,
ESRD facilities located in Guam,
American Samoa, and the Northern
Mariana Islands will be paid under the
ESRD PPS. Under section 1881(h)(1)(A)
of the Act, these facilities will receive a
reduction to their ESRD PPS payments,
beginning with January 1, 2014 dates of
service, if they do not meet the
requirements of the ESRD QIP.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
B. Considerations in Updating and
Expanding Quality Measures Under the
ESRD QIP for PY 2016 and Subsequent
PYs
1. Value-Based Purchasing (VBP)
Overview
Throughout the past decade, Medicare
has been transitioning from a program
that pays for healthcare based on
particular services furnished to a
beneficiary to a program that ties
payments to providers and suppliers
based on the quality of services they
deliver. By paying for the quality of care
rather than quantity of care, we believe
we are strengthening the healthcare
system by focusing on better care and
lower costs through improvement,
prevention and population health,
expanded healthcare coverage, and
enterprise excellence—while also
advancing the National Strategy for
Quality Improvement in Health Care
(National Quality Strategy). CMS is
currently working to update a set of
domains and specific measures of
VerDate Mar<15>2010
18:07 Jul 05, 2013
Jkt 229001
quality for our VBP programs, and to
link the aims of the National Quality
Strategy with our payment policies on a
national scale. We are working in
partnership with beneficiaries,
providers, advocacy groups, the
National Quality Forum (NQF), the
Measures Application Partnership,
operating divisions within the
Department of Health and Human
Services (HHS), and other stakeholders
to develop new measures where gaps
exist, refine measures requiring
adjustment, and remove measures when
appropriate. We are also collaborating
with stakeholders to ensure that the
ESRD QIP serves the needs of our
beneficiaries and also advances the
goals of the National Quality Strategy to
coordinate healthcare delivery, reduce
healthcare costs, enhance patient
satisfaction, promote healthy
communities, and increase patient
safety.1
We believe that the development of an
ESRD QIP that is successful in
supporting the delivery of high-quality
healthcare services in dialysis facilities
is paramount. We seek to adopt
measures for the ESRD QIP that promote
better, safer, and more efficient care.
Our measure development and selection
activities for the ESRD QIP take into
account national priorities such as those
established by the National Priorities
Partnership (https://
www.nationalprioritiespartnership.org/),
HHS Strategic Plan (https://
www.hhs.gov/secretary/about/priorities/
priorities.html), the National Strategy
for Quality Improvement in Healthcare
(https://www.healthcare.gov/center/
reports/quality03212011a.html), and the
HHS National Action Plan to Prevent
Healthcare Associated Infections (HAIs)
(https://www.hhs.gov/ash/initiatives/hai/
esrd.html). To the extent feasible and
practicable, we have sought to adopt
measures that have been endorsed by a
national consensus organization,
recommended by multi-stakeholder
organizations, and developed with the
input of providers, beneficiaries, and
other stakeholders.
2. Brief Overview of Proposed PY 2016
Measures
For the PY 2016 ESRD QIP and future
payment years, we are proposing a total
of 14 measures. We believe that the PY
2016 ESRD QIP proposed measures
promote high-quality care for patients
with ESRD, and also strengthen the
goals of the National Quality Strategy.
Annual Progress Report to Congress:
National Strategy for Quality Improvement in
Health Care, https://www.ahrq.gov/
workingforquality/nqs/nqs2012annlrpt.pdf.
PO 00000
1 2012
Frm 00021
Fmt 4701
Sfmt 4702
40855
The following measures seek to evaluate
facilities on the clinical quality of care:
• To evaluate anemia management:
Æ Hemoglobin Greater Than 12 g/dL,
a clinical measure
Æ Patient Informed Consent for
Anemia Treatment, a clinical
measure*
Æ Pediatric Iron Therapy, a reporting
measure*
Æ Anemia Management, a reporting
measure (revised)
• To evaluate dialysis adequacy:
Æ A Kt/V measure for adult
hemodialysis patients, a clinical
measure
Æ A Kt/V measure for adult peritoneal
dialysis patients, a clinical measure
Æ A Kt/V measure for pediatric
hemodialysis patients, a clinical
measure
• To determine whether patients are
treated using the most beneficial type
of vascular access:
Æ An arterial venous (AV) fistula
measure, a clinical measure
Æ A catheter measure, a clinical
measure
• To address effective bone mineral
metabolism management:
Æ Hypercalcemia, a clinical measure*
Æ Mineral Metabolism, a reporting
measure (revised)
• To address patient safety:
Æ National Healthcare Safety Network
(NHSN) Bloodstream Infection in
Hemodialysis Outpatients, a
clinical measure*
• To address patient-centered
experience:
Æ In-Center Hemodialysis Consumer
Assessment of Healthcare Providers
and Systems (ICH CAHPS), a
reporting measure**
• To gather data regarding
comorbidities:
Æ Comorbidity, a reporting measure*
** Indicates that the measure is new to the
ESRD QIP.
*** Indicates that the measure is newly
expanded or converted to a clinical measure
in the ESRD QIP.
At this time, we are not proposing to
adopt measures that address care
coordination, efficiency, population and
community health, or cost of care.
However, we are soliciting comments in
this proposed rule on potential
measures that would cover these areas.
We welcome further comments on these
and other potential measures for future
program years.
3. Measures Application Partnership
Review
Section 1890A(a)(1) of the Act, as
added by section 3014(b) of the
E:\FR\FM\08JYP2.SGM
08JYP2
40856
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
Affordable Care Act, requires the entity
with a contract under section 1890(a) of
the Act (currently the NQF) to convene
multi-stakeholder groups to provide
input to the Secretary on the selection
of quality and efficiency measures for
use in certain programs. Section
1890A(a)(2) of the Act requires the
Secretary to make available to the public
(not later than December 1 of each year)
a list of quality and efficiency measures
that are under consideration for use in
certain programs. Section 1890A(a)(3) of
the Act requires the entity with a
contract under section 1890(a) of the
Act to transmit the input of the multistakeholder groups to the Secretary not
later than February 1 of each year,
beginning in 2012. Section 1890A(a)(4)
of the Act requires the Secretary to take
into consideration the input of the
multi-stakeholder groups in selecting
quality and efficiency measures. The
Measures Application Partnership is the
public/private partnership comprised of
multi-stakeholder groups convened by
NQF for the primary purpose of
providing input on measures as required
by sections 1890A(a)(1) and (3) of the
Act. The Measures Application
Partnership’s input on the quality and
efficiency measures under consideration
for adoption in CY 2013 was transmitted
to the Secretary on February 1, 2013,
and is available at (https://
www.qualityforum.org/
Setting_Priorities/Partnership/
MAP_Final_Reports.aspx). As required
by section 1890A(a)(4) of the Act, we
considered these recommendations in
selecting quality and efficiency
measures for the ESRD QIP.
We publicly made available a number
of measures in accordance with section
1890A(a)(2) of the Act, and these
measures were reviewed by the
Measures Application Partnership. Of
these measures, a subset is related to a
number of proposed new measures for
the PY 2016 ESRD QIP (one each for
anemia management, hypercalcemia,
infection monitoring, comorbidity
reporting, and ESA usage). The
Measures Application Partnership
supported the following:
• NQF-endorsed measure NQF #1454:
Proportion of patients with
hypercalcemia
• NQF-endorsed measure NQF #1433:
Use of Iron Therapy for Pediatric
Patients (which forms the basis for the
proposed Pediatric Iron Therapy
reporting measure)
• NQF-endorsed measure NQF #1460:
National Healthcare Safety Network
(NHSN) Bloodstream Infection
Measure (which forms the basis for
the proposed Bloodstream Infection in
Hemodialysis Outpatients clinical
measure)
• NQF-endorsed measure NQF #0369:
Dialysis Facility Risk-adjusted
Standardized Mortality Ratio (the
proposed Comorbidity reporting
measure may assist in calculating
performance on this measure, should
we propose to adopt it in the future)
The Measures Application Partnership
supported the direction of the following
measures:
• NQF-endorsed measure NQF #1463:
Standardized Hospitalization Ratio for
Admissions (the proposed
Comorbidity reporting measure may
assist in calculating performance on
this measure, should we propose to
adopt it in the future)
• Measures Application Partnership
#2774: Blood Transfusion
Appropriateness (which forms the
basis for the Patient Informed Consent
for Anemia Treatment clinical
measure)
We have taken comments from the
Measures Application Partnership and
the NQF into consideration for the PY
2016 ESRD QIP. In the measures section
below, we further discuss these
considerations, describe our proposals
for the PY 2016 ESRD QIP, and provide
rationale for why we believe it is
appropriate to propose the measures at
this time.
C. Proposed Measures for the PY 2016
ESRD QIP and Subsequent PYs of the
ESRD QIP
We previously finalized ten measures
in the CY 2013 ESRD PPS final rule for
the PY 2015 ESRD QIP and future PYs
(77 FR 67471), and these measures are
summarized in Table 6 below. We are
proposing to continue to use nine of the
ten measures for the PY 2016 ESRD QIP
and future payment years, modifying
three of the measures as follows:
• ICH CAHPS (reporting measure):
Expand
• Mineral Metabolism (reporting
measure): Revise
• Anemia Management (reporting
measure): Revise
For the PY 2016 ESRD QIP and future
payment years, we are also proposing to
add three new clinical measures (Patient
Informed Consent for Anemia
Treatment, Hypercalcemia, and NHSN
Bloodstream Infection in Hemodialysis
Outpatients), and two new reporting
measures (Pediatric Iron Therapy, and
Comorbidity). (See Table 7) We believe
that, collectively, these measures will
continue to promote improvement in
dialysis care in the PY 2016 ESRD QIP
and in future payment years.
TABLE 6—MEASURES ADOPTED FOR THE PY 2015 ESRD QIP AND FUTURE PAYMENT YEARS
NQF No.
Measure title and description
N/A ....................
Anemia Management: Hgb >12.
Percentage of Medicare patients with a mean hemoglobin value greater than 12 g/dL.
Hemodialysis Adequacy: Minimum delivered hemodialysis dose.
Percent of hemodialysis patient-months with spKt/V greater than or equal to 1.2.
Peritoneal Dialysis Adequacy: Delivered dose above minimum.
Percent of peritoneal dialysis patient-months with spKt/V greater than or equal to 1.7 (dialytic + residual) during the four
month study period.
Pediatric Hemodialysis Adequacy: Minimum spKt/V.
Percent of pediatric in-center hemodialysis patient-months with spKt/V greater than or equal to 1.2.
Vascular Access Type: Arterial Venous (AV) Fistula.
Percentage of patient-months on hemodialysis during the last hemodialysis treatment of the month using an autogenous AV
fistula with two needles.
Vascular Access Type: Catheter >= 90 days.
Percentage of patient-months for patients on hemodialysis during the last hemodialysis treatment of month with a catheter
continuously for 90 days or longer prior to the last hemodialysis session.
National Healthcare Safety Network (NHSN) Dialysis Event Reporting.
Number of months for which facility reports NHSN Dialysis Event data to the Centers for Disease Control and Prevention
(CDC).
In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey Administration +.
Attestation that facility administered survey in accordance with specifications.
0249 ..................
0318 ..................
1423 ..................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
0257 ..................
0256 ..................
N/A 1 ..................
N/A 2 ..................
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00022
Fmt 4701
Sfmt 4702
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
40857
TABLE 6—MEASURES ADOPTED FOR THE PY 2015 ESRD QIP AND FUTURE PAYMENT YEARS—Continued
NQF No.
Measure title and description
N/A 3 ..................
Mineral Metabolism Reporting +.
Number of months for which facility reports uncorrected serum calcium and phosphorus for each Medicare patient.
Anemia Management Reporting +.
Number of months for which facility reports ESA dosage (as applicable) and hemoglobin/hematocrit for each Medicare patient.
N/A ....................
1 We
note that an NQF-endorsed bloodstream infection measure (NQF#1460) exists.
note that a related measure utilizing the results of this survey has been NQF-endorsed (#0258). It is our intention to use this measure in
future years of the ESRD QIP. We believe that a reporting measure is a necessary step in reaching our goal to implement NQF#0258.
3 We note that this measure is based upon a current NQF-endorsed serum phosphorous measure (#0255), and a calcium monitoring measure
that NQF had previously endorsed (#0261).
+ Indicates a measure we are proposing to revise for PY 2016 and future years of the ESRD QIP.
2 We
TABLE 7—NEW MEASURES PROPOSED FOR THE PY 2016 ESRD QIP AND FUTURE PAYMENT YEARS
NQF No.
Measure title
N/A ....................
N/A 1 ..................
1454 ..................
N/A 2 ..................
N/A 3 ..................
Anemia of chronic kidney disease: Patient Informed Consent for Anemia Treatment.
Use of Iron Therapy for Pediatric Patients Reporting.
Proportion of Patients with Hypercalcemia.
NHSN Bloodstream Infection in Hemodialysis Outpatients.
Comorbidity Reporting.
1 We
note that the NQF has previously endorsed a pediatric iron therapy measure (#1433) upon which this measure is based.
note that the NQF has previously endorsed a National Healthcare Safety Network (NHSN) bloodstream infection measure (#1460) upon
which this measure is based.
3 We note that the NQF has previously endorsed risk-adjusted hospitalization and mortality measures (#1463 and #0369). The proposed Comorbidity reporting measure may assist in calculating performance on these measures, should we propose to adopt them in the future.
2 We
tkelley on DSK3SPTVN1PROD with PROPOSALS2
1. PY 2015 Measures Continuing in PY
2016 and Future Payment Years
We are continuing using six measures
adopted in the CY 2013 ESRD PPS final
rule for the PY 2016 ESRD QIP and
future payment years of the program.
We are also continuing to use two
measure topics adopted. Proposals for
scoring these measures are discussed in
sections III.C.5 through III.C.11 and
III.C.13. For the reasons stated in the CY
2012 ESRD PPS final rule (76 FR 70262,
70264 through 70265, 70269) and in the
CY 2013 ESRD PPS final rule (77 FR
67478 through 67480, 67487 through
67490), we will continue using:
1. (i) The Hemoglobin Greater than 12
g/dL measure.
The Dialysis Adequacy measure topic,
which is comprised of
2. (a) Hemodialysis Adequacy Clinical
Performance Measure III: Hemodialysis
Adequacy—HD Adequacy—Minimum
Delivered Hemodialysis Dose (NQF
#0249),
3. (b) Peritoneal Dialysis Adequacy
Clinical Performance Measure III—
Delivered Dose of Peritoneal Dialysis
Above Minimum (NQF #0318); and
4. (c) Minimum spKt/V for Pediatric
Hemodialysis Patients (NQF #1423); and
The Vascular Access Type measure
topic, which is comprised of
5. (a) Vascular Access Type: Arterial
Venous (AV) Fistula (NQF #0257); and
6. (b) Vascular Access Type: Catheter
>= 90 days (NQF #0256).
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
The technical specifications for these
measures can be found at: https://
www.dialysisreports.org/
ESRDMeasures.aspx.
2. Proposal To Expand One PY 2015
Measure and Revise Two PY 2015
Measures for PY 2016 and Subsequent
Payment Years
As stated earlier, we believe it is
important to continue using measures
from one payment year to the next
payment year of the program to
encourage continued improvements in
patient care. Therefore, we are
proposing to expand and revise the
measures discussed below that we
finalized in the CY 2013 ESRD PPS final
rule. For all measures except for ICH
CAHPS reporting measure, these
proposed and revised requirements
would apply to the measures for PY
2016 and future payment years. For the
ICH CAHPS measure, certain proposed
expanded requirements would apply to
PY 2016, and some additional proposed
requirements would apply to PY 2017
and future payment years.
a. Proposed Expanded ICH CAHPS
Reporting Measure
Patient-centered experience is an
important measure of the quality of
patient care. It is a component of the
National Quality Strategy. The NQF
endorses and the Measures Application
Partnership supports a clinical measure
on this topic, NQF #0285: CAHPS InCenter Hemodialysis Survey, which is
PO 00000
Frm 00023
Fmt 4701
Sfmt 4702
based on how facilities perform on the
CAHPS survey. In PY 2015, we
continued to use a reporting measure
related to the ICH CAHPS survey,
requiring that facilities attest they had
administered the survey according to
the specifications set by the Agency for
Healthcare Research and Quality
(AHRQ), but not requiring the
submission of survey data. We required
that facilities attest by January 31, 2014
to administering the ICH CAHPS survey
during the performance period (77 FR
67480 through 67481).
We are taking several steps to develop
the baseline data necessary to propose
and implement NQF #0258 as a clinical
measure in the PY 2018 ESRD QIP. We
expect to be able to certify ICH CAHPS
survey vendors beginning in early CY
2014. We are also building the capacity
to accept survey data, developing
detailed specifications for administering
the ICH–CAHPS survey in light of
questions vendors asked about previous
procedures, and developing
specifications for submitting data to
CMS, such as file specifications,
structure and instructions that the
survey vendors will use. We have taken
these steps in order to make it possible
for facilities to contract with third party
vendors to transfer survey data results to
CMS, so that we might collect the
baseline data necessary to propose and
implement NQF #0258.
For PY 2016, we are proposing that
each facility arrange by July 2014 for a
CMS-approved vendor to conduct the
E:\FR\FM\08JYP2.SGM
08JYP2
40858
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
ICH CAHPS survey according to CMS
(rather than AHRQ) specifications,
available at the ICH CAHPS Web site
(https://ichcahps.org). Facilities will
need to register on the https://
ichcahps.org Web site in order to
authorize the CMS-approved vendor to
administer the survey and submit data
on their behalf. Each facility must then
administer (via its vendor) the survey
once during the proposed performance
period and, by 11:59 ET on January 28,
2015, report the survey data to CMS
using the specifications on the ICH
CAHPS Web site.
For PY 2017 and subsequent payment
years, we are proposing similar
requirements except that each facility
must arrange to have the survey
administered twice during each
performance period and must report the
data (via its CMS-approved vendor) to
CMS by the date specified on the ICH
CAHPS Web site.
Although we have required that other
types of providers, including home
health agencies and acute care hospitals,
administer and submit CAHPS survey
data on a monthly, continuous basis, we
recognize that there are generally low
rates of turnover in dialysis facility
patient populations. For this reason, we
do not see the same need to require
facilities to administer the survey as
frequently and, as proposed above,
would require facilities to administer
the survey once during the performance
period for PY 2016 (in order to allow
facilities enough time to select a vendor)
and twice for subsequent payment
years. We believe that this frequency of
survey administration will enable us to
gather sufficient data to adopt in future
rulemaking, a clinical version of this
measure without unduly burdening
facilities. We request comment on this
proposal. The technical specifications
for this measure are located at https://
www.dialysisreports.org/pdf/esrd/
public-measures/ICHCAHPS2016NPRM.pdf.
b. Proposed Revised Mineral
Metabolism Reporting Measure
Adequate management of bone
mineral metabolism and disease in
ESRD patients continues to be a high
priority because it can cause severe
consequences such as osteoporosis,
osteomalacia, and hyperparathyroidism.
The PY 2015 ESRD QIP has a reporting
measure focused on mineral metabolism
(77 FR 67484 through 67487). We are
proposing two changes for PY 2016 and
future payment years. First, when we
finalized the measure in the CY 2013
ESRD PPS final rule, we inadvertently
excluded home peritoneal patients from
the measure specifications. For PY 2016
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
and future payment years, we are now
proposing to include home peritoneal
patients in the Mineral Metabolism
reporting measure. Therefore, we are
proposing that a qualifying case for this
measure will be defined as (i) an incenter Medicare patient who had been
treated at least seven times by the
facility; and (ii) a home dialysis
Medicare patient for whom the facility
submitted a claim at least once per
month.
Second, if the proposed
Hypercalcemia clinical measure
(described below) is finalized based on
public comment, then we believe it
would be redundant, and unduly
burdensome, for facilities to also
continue reporting serum calcium levels
as part of the mineral metabolism
reporting measure. Accordingly, in light
of our proposal to adopt the
hypercalcemia measure, we are
proposing to change the specifications
for the mineral metabolism measure
such that it no longer requires facilities
to report serum calcium levels. We
welcome comments on this proposal,
and in particular on whether we should
retain the reporting of serum calcium
levels as part of the mineral metabolism
reporting measure if we do not finalize
the proposed hypercalcemia measure.
As described in more detail below
(Proposed Minimum Data for Scoring
Measures), we are also proposing to
eliminate the 11-case minimum for this
measure, which was finalized in the CY
2013 ESRD PPS final rule at 77 FR
67486. Because of the proposed revised
case minimum, and because there are
circumstances that might make it
challenging for a facility to draw a
sample from certain patients, such as
those who are admitted to hospital
during the month, we are proposing
that, in order to receive full points on
this measure, facilities that treat 11 or
more qualifying cases over the entire
performance period will have to report
at the lesser of the 50th percentile of
facilities in CY 2013 or 97 percent per
month, on a monthly basis, for each
month of the performance period. We
are further proposing that facilities that
treat fewer than 11 qualifying cases
during the performance period will have
to report on a monthly basis the
specified levels for all but one
qualifying case. If a facility only has one
qualifying case during the entire
performance period, a facility will have
to attest to that fact in CROWNWeb by
January 31 of the year following the
performance period in order to avoid
being scored on the measure. We make
this proposal because we seek to ensure
the highest quality of care regardless of
facility size, and because we seek to
PO 00000
Frm 00024
Fmt 4701
Sfmt 4702
mitigate cherry-picking by ensuring that
one patient does not skew a facility’s
score (77 FR 67474).
We welcome comments on this
proposal. Technical specifications for
this proposed measure can be found at:
https://www.dialysisreports.org/pdf/esrd/
public-measures/MineralMetabolismHypercalcemia-2016NPRM.pdf.
c. Proposed Revised Anemia
Management Reporting Measure
Section 1881(h)(2)(A)(i) requires
‘‘measures on anemia management that
reflect the labeling approved by the
Food and Drug Administration (FDA)
for such management.’’ In the CY 2013
ESRD PPS final rule, we finalized an
Anemia Management reporting measure
for the reasons stated in that final rule
(77 FR 67491 through 67495). However,
we inadvertently excluded home
peritoneal patients from the measure
specifications. For PY 2016 and future
payment years, we are now proposing to
include home peritoneal patients in the
Anemia Management reporting measure.
Therefore, we are proposing that a
qualifying case for this measure will be
defined as (i) an in-center Medicare
patient who had been treated at least
seven times by the facility; and (ii) a
home dialysis Medicare patient for
whom the facility submitted a claim at
least once per month.
We believe that there are
circumstances that might make it
challenging to draw a sample from
certain patients, and therefore, we are
proposing that, in order to receive full
points on this measure, facilities that
treat 11 or more qualifying cases over
the entire performance period must
report at the lesser of the 50th percentile
of facilities in CY 2013 or 99 percent per
month, on a monthly basis for each
month of the performance period. In
addition, we are proposing that, in order
to receive full points on this measure,
facilities that treat fewer than 11
qualifying cases during the performance
period must report on a monthly basis
the specified levels for all but one
qualifying case. If a facility only has one
qualifying case during the entire
performance period, a facility will have
to attest to that fact in CROWNWeb by
January 31 of the year following the
performance period in order to avoid
being scored on the measure. We make
this proposal because we seek to ensure
the highest quality of care regardless of
facility size, and because we seek to
mitigate cherry-picking by ensuring that
one patient does not skew a facility’s
score (77 FR 67474).
Technical specifications for this
proposed measure can be found at:
https://www.dialysisreports.org/pdf/esrd/
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
public-measures/AnemiaManagementReporting-2016NPRM.pdf. We request
comment on this proposal to revise the
Anemia Management reporting measure.
3. New Measures Proposed for PY 2016
and Subsequent Payment Years of the
ESRD QIP
As the program evolves, we believe it
is important to continue to evaluate and
expand the measures selected for the
ESRD QIP. Therefore, for the PY 2016
ESRD QIP and future payment years, we
are proposing to adopt five new
measures. The proposed new measures
include two measures on anemia
management, one measure on mineral
metabolism, one measure on
bloodstream infection monitoring, and
one measure on comorbidities.
a. Proposed Anemia Management
Clinical Measure Topic and Measures
Section 1881(h)(2)(A)(i) of the Act
states that the measures specified for the
ESRD QIP are required to include
measures on ‘‘anemia management that
reflect the labeling approved by the
Food and Drug Administration for such
management.’’ For PY 2016 and future
payment years, we are proposing to
create a new anemia management
clinical measure topic, which consists
of one measure initially finalized in the
PY 2012 ESRD QIP final rule and most
recently finalized for PY 2015 and
future PYs in the CY 2013 ESRD PPS
final rule, and one new proposed
measure, described below. We note that,
like other measure topics, we are
proposing that the Anemia Management
clinical measure topic consist only of
clinical and not reporting measures.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
i. Anemia Management: Hgb>12
For the PY 2016 ESRD QIP and future
payment years of the program, we are
proposing to include the current
Hgb>12 measure in a new Anemia
Management Clinical Measure Topic. In
the event that the Patient Informed
Consent for Anemia Treatment measure
described below is not finalized, we
would retain the Hgb>12 measure as an
independent measure. We welcome
comments on this proposal.
ii. Anemia of Chronic Kidney Disease:
Patient Informed Consent for Anemia
Treatment
This is a measure of the proportion of
dialysis patients for whom a facility
attests that risks, potential benefits, and
alternative treatment options for anemia
were evaluated, and that the patient
participated in the decision-making
regarding an anemia treatment strategy.
We believe that this measure is
consistent with recent changes to the
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
FDA-approved labeling 2 for ESAs and
Kidney Disease: Improving Global
Outcomes (KDIGO) Anemia
Management Guidelines 3 that highlight
the evolving understanding of risks
associated with ESA therapy, as
required in section 1881(h)(2)(A)(i) of
the Act. We believe it is appropriate for
facilities and physicians to ensure that
steps are taken to make patients aware
of those potential risks within the
context of treatment for anemia. For
these reasons, we are proposing to adopt
this measure (Anemia of Chronic
Kidney Disease: Patient Informed
Consent for Anemia Treatment) for the
ESRD QIP in PY 2016 and future
payment years of the program. In order
to meet the requirements of this
proposed measure, facilities must attest
in CROWNWeb for each qualifying
patient, on an annual basis, that
informed consent was obtained from
that patient, or that patient’s legally
authorized representative, during the
performance period. We propose that
qualifying cases for this measure would
be defined as patients who received
dialysis in the facility for 30 days or
more. The proposed deadline for
reporting these attestations for the PY
2016 ESRD QIP will be January 31, 2015
or, if that is not a regular business day,
the first business day thereafter. Missing
attestation data for a patient will be
interpreted as failure to obtain informed
consent from that patient.
We welcome comments on this
proposed measure. Technical
specifications for this proposed measure
can be found at: https://
www.dialysisreports.org/pdf/esrd/
public-measures/AnemiaManagementInformedConsent-2016NPRM.pdf.
b. Hypercalcemia
Section 1881(h)(2)(A)(iii)(II) of the Act
states that the measures specified for the
ESRD QIP shall include other measures
as the Secretary specifies, including, to
the extent feasible, measures of bone
mineral metabolism. Abnormalities of
bone mineral metabolism are
exceedingly common, and contribute
significantly to morbidity and mortality
in patients with advanced Chronic
Kidney Disease (CKD). Many studies
have associated disorders of mineral
metabolism with mortality, fractures,
cardiovascular disease, and other
morbidities. Therefore, we believe it is
critical to adopt a clinical measure that
encourages adequate management of
2 https://www.fda.gov/Drugs/DrugSafety/
ucm259639.htm.
3 Kidney Disease: Improving Global Outcomes
(KDIGO) Anemia Work Group. KDIGO Clinical
Practice Guideline for Anemia in Chronic Kidney
Disease. Kidney inter., Suppl. 2012 (2): 279–335.
PO 00000
Frm 00025
Fmt 4701
Sfmt 4702
40859
bone mineral metabolism and disease in
ESRD patients.
Elevated serum calcium level (or
hypercalcemia) has been shown to be
significantly associated with increased
all-cause mortality in patients with
advanced Chronic Kidney Disease
(CKD). Both KDIGO Clinical Practice
Guideline for the Diagnosis, Evaluation,
Prevention, and Treatment of Chronic
Kidney Disease—Mineral and Bone
Disorder (CKD—MBD) and the National
Kidney Foundation’s Kidney Disease
Outcomes Quality Initiative (KDOQI)
support maintaining serum calcium
levels within reference ranges.
Hypercalcemia is also a proxy for
vascular and/or valvular calcification 4 5
and subsequent risk for cardiovascular
deaths. We previously proposed a
hypercalcemia clinical measure for the
PY 2015 ESRD QIP (77 FR 40973
through 40974), but decided not to
finalize the measure because we lacked
baseline data that could be used to
calculate performance standards,
achievement thresholds, and
benchmarks (77 FR 67490 through
67491). We now possess enough
baseline data to calculate these values.
Therefore, we are proposing to adopt the
NQF-endorsed measure NQF #1454:
Proportion of Patients with
Hypercalcemia, for PY 2016 and future
payment years of the ESRD QIP.
The proposed Hypercalcemia measure
assesses the number of patients with
uncorrected serum calcium greater than
10.2 mg/dL for a 3-month rolling
average. (‘‘Uncorrected’’ means not
corrected for serum albumin
concentration.) In order to enable us to
calculate this measure, each facility will
be required to enter in CROWNWeb, on
a monthly basis, an uncorrected calcium
level for each in-center and home
dialysis patient over the age of eighteen.
Performance on this measure is
expressed as a proportion of patientmonths for which the 3-month rolling
average exceeds 10.2 mg/dL. The
numerator is the total number of eligible
patient-months where the 3-month
rolling average is greater than 10.2 mg/
dL and the demoninator is the total
number of eligible patient-months. We
are proposing that facilities would begin
to submit data on this measure based on
January 2014 uncorrected serum
4 Wang A, Woo J, Law C, et al. Cardiac Valve
Calcification as an Important Predictor for AllCause Mortality and Cardiovascular Mortality in
Long-Term Peritoneal Dialysis Patients: A
Prospective Study. J Am. S. Nephrology 2011
(14/1): 159–168.
5 Wang A, Ho S, Wang M, et al. Cardiac Valvular
Calcification as a Marker of Atherosclerosis and
Arterial Calcification in End-stage Renal Disease.
JAMA 2005 (165/3): 327–332.
E:\FR\FM\08JYP2.SGM
08JYP2
40860
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
calcium levels but that we would
calculate the first 3-month rolling
average for each eligible patient in
March 2014 using January, February,
and March 2014 data. We would then
calculate a new 3-month rolling average
each successive eligible patient-month
(April through December measure
calculations) by dropping the oldest
month’s data and using instead the
newest month’s data in the 3-month
period. The facility’s performance will
be determined by calculating the
proportion of the 3-month averages
calculated monthly (March through
December, each time using the latest
three months of data) for all eligible
patients that was greater than 10.2 mg/
dL.
Because we are proposing to adopt
this measure not only for PY 2016, but
also subsequent payment years, we also
propose that, beginning with the PY
2017 program, we would measure
hypercalcemia beginning in January of
the applicable performance period. This
will allow us to have a 3-month rolling
average for all months in the
performance period. We propose that
the 3-month rolling average rate for
January would be calculated using the
rates from November and December of
the previous year as well as January of
that year. Likewise, we propose that the
rate for February would be calculated
using the rates from December, January
and February to calculate the 3-month
rolling average, and so on.
Technical specifications for this
measure can be found at https://
www.dialysisreports.org/pdf/esrd/
public-measures/MineralMetabolismHypercalcemia-2016NPRM.pdf. We
welcome comments on this proposal.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
c. Use of Iron Therapy for Pediatric
Patients Reporting Measure
Section 1881(h)(2)(A)(i) states that the
ESRD QIP must include measures on
‘‘anemia management that reflect the
labeling approved by the Food and Drug
Administration for such management.’’
Appropriate anemia management
requires the presence of sufficient stores
of iron.6 Iron deficiency is a leading
cause of non-response to ESA therapy,
and several studies suggest that
providing oral or IV iron is effective in
correcting iron deficiency in the
pediatric population.7 8 Pediatric
6 Seeherunvong W, Rubio L, Abitbol CL, et al.
Identification of poor responders to erythropoietin
among children undergoing hemodialysis. J Pediatr
2001 (138/5):710–714.
7 Warady BA, Zobrist RH, Wu J, Finan E. Sodium
ferric gluconate complex therapy in anemic
children on hemodialysis. Pediatr Nephrol 20:
1320–7, 2005.
8 Frankenfield DL, Neu AM, Warady BA, et al.
Anemia in pediatric hemodialysis patients: Results
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
patients have previously been excluded
from all anemia management measures,
limiting the participation of dialysis
facilities with substantial numbers of
pediatric patients in the ESRD QIP. In
an effort to address this issue, and
account for the quality of care dialysis
facilities provide to pediatric patients,
we are proposing to adopt a pediatric
iron therapy measure for the ESRD QIP
in PY 2016 and future payment years of
the program.
We considered proposing an NQFendorsed clinical measure on the use of
iron therapy for pediatric patients as
part of the proposed Anemia
Management clinical measure topic
(NQF #1433: Use of Iron Therapy for
Pediatric Patients). This measure is an
assessment of the percentage of all
pediatric hemodialysis and peritoneal
dialysis patients who received IV iron or
were prescribed oral iron within three
months of attaining the following
conditions: (i) Patient had hemoglobin
less than 11.0 g/dL; (ii) patient had
simultaneous values of serum ferritin
concentration less than 11.0; and (iii)
patient’s transferrin saturation (TSAT)
was less than 20 percent. Upon
investigation, we discovered that there
were not enough patients who would
qualify for this measure to establish
reliable baseline data that would allow
us to propose to adopt this measure as
a clinical measure for PY 2016. We also
note that the clinical measure currently
presents other issues related to the
minimum number of cases that would
need to be reported for scoring, and we
are considering the use of an adjuster
that could be applied where the sample
size is small. While we continue to
consider these and other issues related
to the adoption of a pediatric iron
therapy clinical measure, we are
proposing a related reporting measure
for PY 2016 and future payment years
in order to acquire a sufficient amount
of baseline data for the development of
a clinical measure in the future.
For PY 2016 and future payment
years, we are proposing that facilities
must enter in CROWNWeb on a
quarterly basis, for each qualifying case
(defined in the next sentence): (i)
Patient admit/discharge date; (ii)
hemoglobin levels; (iii) serum ferritin
levels; (iv) TSAT percentages; (v) the
dates that the lab measurements were
taken for items (ii)–(iv); (vi) intravenous
IV iron received or oral iron prescribed
(if applicable); and (vii) the date that the
IV iron was received or oral iron was
prescribed (if applicable). We are
proposing that qualifying cases for this
from the 2001 Clinical Performance Measures
Project. Kidney International 64:1120–4, 2003.
PO 00000
Frm 00026
Fmt 4701
Sfmt 4702
measure would be defined as in-center
and home dialysis patients under the
age of eighteen.
As described in more detail below, we
are proposing that each facility must
report data on the Use of Iron Therapy
for Pediatric Patients measure if it treats
one or more qualifying cases during the
performance period. Because this
reporting measure requires that a facility
enter data in CROWNWeb only once per
quarter for each patient, we believe that
the burden is appropriate and will not
unduly impact small facilities, since it
is proportionate to the number of
patients that facilities treat. However,
for the same reasons stated in the final
description of the PY 2014 ESRD QIP
Mineral Metabolism measure (which
had a one patient minimum) (77 FR
67472 through 67474), we are proposing
that, in order to receive full points on
this measure, facilities that treat 11 or
more qualifying cases over the
performance period will have to report
at the lesser of the 50th percentile of
facilities in CY 2013 or 97 percent per
quarter, for each quarter of the
performance period. We are proposing
that facilities that treat fewer than 11
qualifying cases during the performance
period will have to report on a quarterly
basis the specified data elements for all
but one qualifying case. If a facility only
has one qualifying case during the entire
performance period, a facility will have
to attest to that fact in CROWNWeb by
January 31 of the year following the
performance period in order to avoid
being scored on the measure.
The technical specifications for this
measure can be found at: https://
www.dialysisreports.org/pdf/esrd/
public-measures/AnemiaManagementPediatricIronTherapyReporting2016NPRM.pdf. We welcome comment
on this proposal.
d. NHSN Bloodstream Infection in
Hemodialysis Outpatients Clinical
Measure
Healthcare-acquired infections (HAI)
are a leading cause of preventable
mortality and morbidity across different
settings in the healthcare sector,
including dialysis facilities.
Bloodstream infections are a pressing
concern in a population where
individuals are frequently immunocompromised and depend on regular
vascular access to facilitate dialysis
therapy. In a national effort to reduce
infection rates, CMS has partnered with
the CDC to encourage facilities to report
to the NHSN as a way to track and
facilitate action intended to reduce
HAIs. The NHSN is a secure, internetbased surveillance system that is
managed by the Division of Healthcare
E:\FR\FM\08JYP2.SGM
08JYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
Quality Promotion at the CDC. NHSN
has been operational since 2006 and
tracks data from acute care hospitals,
long-term care hospitals, psychiatric
hospitals, rehabilitation hospitals,
outpatient dialysis centers, ambulatory
surgery centers, and long-term care
facilities. We continue to believe that
accurately reporting dialysis events to
the NHSN by these facilities supports
national goals for patient safety,
particularly goals for the reduction of
HAIs. In addition, we believe that
undertaking other activities designed to
reduce the number of HAIs supports
national goals for patient safety. For
further information regarding the
NHSN’s dialysis event reporting
protocols, please see https://
www.cdc.gov/nhsn/dialysis/.
We have worked over the past two
years to help dialysis facilities become
familiar with the NHSN system through
the adoption of an NHSN Dialysis Event
reporting measure. We now believe that
facilities are sufficiently versed in
reporting this measure to the NHSN. In
light of the importance of monitoring
and preventing infections in the ESRD
population, and because a clinical
measure would have a greater impact on
clinical practice by holding facilities
accountable for their actual
performance, we are proposing to
replace the NHSN Dialysis Event
reporting measure that we adopted in
the CY 2013 ESRD PPS final rule (77 FR
67481 through 67484) with a new
clinical measure for PY 2016 and future
payment years. This proposed measure,
NHSN Bloodstream Infection in
Hemodialysis Outpatients, is based
closely NQF #1460, in that it evaluates
the number of hemodialysis outpatients
with positive blood cultures per 100
hemodialysis patient-months.
We are proposing that facilities must
submit 12 months of accurately reported
dialysis event data (defined in the next
sentence) to NHSN on a quarterly basis.
In order to ensure that a facility submits
data that can be used to identify the
source of bloodstream infections, to
preserve the internal validity of
bloodstream infection data, and to help
prevent future bloodstream infections,
we propose to define accurately
reported dialysis event data as data
reported by facilities that follow the
NHSN enrollment and training
guidelines specified by the CDC
(available at: https://www.cdc.gov/nhsn/
dialysis/enroll.html and https://
www.cdc.gov/nhsn/Training/dialysis/
index.html), according to the reporting
requirements specified within the
NHSN Dialysis Event Protocol. (This
protocol, which facilities are already
using to meet the requirements of the
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
NHSN Dialysis Event reporting measure,
includes information about IV
antimicrobial starts and evidence of
vascular access site infection, as well as
information about the presence of a
bloodstream infection.)
Additionally, we are proposing that
each quarter’s data would be due 3
months after the end of that quarter. For
example, data from January 1 through
March 31, 2014 would need to be
entered by June 30, 2014; data from
April 1 through June 30, 2014 would
need to be submitted by September 30,
2014; data from July 1 through
September 30, 2014 would need to be
submitted by December 31, 2014; data
from October 1 through December 31,
2014 would need to be submitted by
March 31, 2015. If facilities do not
report 12 months of these data
according to the requirements and the
deadlines specified above, we propose
that they would receive a score of zero
on the measure. We also propose that
facilities with a CCN open date after
January 1, 2014 will be excluded from
the measure. We note that in previous
payment years we have awarded partial
credit to facilities that submitted less
than twelve months of data to encourage
them to enroll in and report data in the
NHSN system. However, we are
proposing to require 12 months of data
on this clinical measure because
infection rates vary through different
seasons of the year.
We note that this proposed measure
only applies to facilities treating incenter hemodialysis patients (both adult
and pediatric). We will determine
whether a facility treats in-center
patients by referencing the facility’s
information in the Standard Information
Management System and CROWNWeb.
We recognize that the CDC has
published Core Interventions for BSI
Prevention in Dialysis, which are listed
at https://www.cdc.gov/dialysis/
prevention-tools/coreinterventions.html. We encourage
facilities to adopt the nine listed
interventions in order to help prevent
infections, but are not proposing to
require facilities to adopt any of these
interventions at this time.
We request comment on this proposal,
and in particular on the issue of
whether it is appropriate at this time to
convert the current NHSN Dialysis
Event Reporting measure into a clinical
measure. The technical specifications
for this measure are located at https://
www.dialysisreports.org/
ESRDMeasures.aspx.
e. Comorbidity Reporting Measure
The NQF endorsed a clinical measure
for Dialysis Facility Risk-Adjusted
PO 00000
Frm 00027
Fmt 4701
Sfmt 4702
40861
Standardized Mortality Ratio (#0369) in
2008, and a clinical measure for
Standardized Hospitalization Ratio for
Admissions (#1463) in 2011. We have
long been interested in adding a
Standardized Mortality Ratio (SMR)
measure and a Standardized
Hospitalization Ratio (SHR) measure to
the ESRD QIP. As articulated in the CY
2013 ESRD PPS final rule, ‘‘We believe
that dialysis facilities own partial
responsibility for the rate at which their
patients are hospitalized, in particular
when that rate is substantially higher
than at other peer facilities and may not
be explained by variation in the illness
of patients’’ (77 FR 67496). Similarly,
we continue to believe that the ‘‘SMR
may help distinguish the quality of care
offered by dialysis facilities as
determined by mortality, a key health
care outcome used to assess quality of
care in other settings, such as hospitals’’
(77 FR 67497).
Although we believe that SHR and
SMR capture important indicators of
morbidity and mortality, we are
considering whether, and how, we
might be able to adopt them through
future rulemaking in a way that
properly takes into account the effect
that comorbidities have on
hospitalization and mortality rates for
the ESRD population. We also
acknowledge concerns raised by
commenters in the past that the NQFendorsed SMR and SHR measures are
not adequately risk adjusted (77 FR
67496). Currently, information about
patient comorbidities is collected by
CMS via the Medical Evidence
Reporting Form 2728, which is typically
only submitted by facilities to CMS
when a new patient first begins to
receive dialysis treatment. We also use
Form 2728 to capture the date of first
dialysis in order to help determine
patient exclusions for all of the clinical
measures finalized in the PY 2013 ESRD
PPS final rule. However, facilities are
not required to update this form, which
makes it difficult to capture information
about comorbidities that develop after
the initiation of dialysis treatment. We
acknowledge the concerns of
commenters who stated that ‘‘there is
currently no mechanism either for
correcting or updating patient
comorbidity data on CMS’ Medical
Evidence Reporting Form 2728, and
these comorbidities affect the
calculation of the measure’’ (76 FR
70267).
We are proposing to adopt a
Comorbidity reporting measure for the
PY 2016 ESRD QIP and future payment
years of the ESRD QIP. The purpose of
this measure is two-fold. First, the
proposed reporting measure offers a
E:\FR\FM\08JYP2.SGM
08JYP2
40862
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
facility care, as opposed to factors
outside of a facility’s control.
Section 1881(h)(2)(B)(i) of the Act
requires that, unless the exception set
forth in section 1881(h)(2)(B)(ii) of the
Act applies, the measures specified for
the ESRD QIP under section
1881(h)(2)(A)(iii) of the Act must have
been endorsed by the entity with a
contract under section 1890(a) of the
Act (which is currently NQF). Under the
exception set forth in section
1881(h)(2)(B)(ii) of the Act, in the case
of a specified area or medical topic
determined appropriate by the Secretary
for which a feasible and practical
measure has not been endorsed by the
entity with a contract under section
1890(a) of the Act, the Secretary may
specify a measure that is not so
endorsed, so long as due consideration
is given to measures that have been
endorsed or adopted by a consensus
organization identified by the Secretary.
NQF has not endorsed a measure for
updating comorbidity information for
patients with ESRD. We have given due
consideration to endorsed measures, as
well as those adopted by a consensus
organization, and we are proposing this
measure under the authority of
1881(h)(2)(B)(ii) of the Act. We believe
that the proposed measure’s potential to
improve clinical understanding and
practice outweighs the minimal burden
it would impose upon facilities.
Additionally, we believe that this
measure will provide data that is
currently unavailable through Form
2728 because the measure accounts for
the most recent information about
patient risk factors, which may change
over time as a patient continues
receiving dialysis.
For this proposed reporting measure,
we are proposing each facility will
annually update in CROWNWeb up to
24 comorbidities, or indicate ‘‘none of
the above,’’ for each qualifying case. For
the purposes of this measure, we are
proposing to define a ‘‘qualifying case’’
as a hemodialysis or peritoneal dialysis
patient being treated at the facility as of
December 31 of the performance period,
according to admit and discharge dates
entered into CROWNWeb. In fulfilling
this reporting requirement, facilities
would select one or more of the
following for each qualifying case:
•
•
•
•
•
•
•
•
•
tkelley on DSK3SPTVN1PROD with PROPOSALS2
mechanism for collecting annual
information about patient comorbidities,
thereby providing a reliable source of
data that we can use to develop a riskadjustment methodology for the SHR
and SMR clinical measures, should we
propose to adopt such measures in the
future. Second, the reporting measure
will make it possible to improve our
understanding of the risk factors that
contribute to morbidity and mortality in
the ESRD patient population. The data
we gather will enable us to develop riskadjustment methodologies for possible
use in calculating the SHR and SMR
measures, should we propose to adopt
those measures in the future, and
therefore more reliably calculate
expected hospitalization and mortality
rates in future payment years of the
ESRD QIP. When we examine updated
data on comorbidities, we will
determine the appropriateness of
including that data as additional riskadjustment factors for the SMR and SHR
measures by considering the extent to
which each comorbidity may be
influenced by the quality of dialysis
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Congestive heart failure.
Atherosclerotic heart disease (ASHD).
Other cardiac disease.
Cerebrovascular disease (CVA, TIA).
Peripheral vascular disease.
History of hypertension.
Amputation.
Diabetes, currently on insulin.
None of the above.
Therefore, to receive full points on
this measure, we are proposing that
facilities would be required to provide
the updates in CROWNWeb by January
31, 2015 or, if that is not a regular
business day, the first business day
thereafter. While we are proposing to
require facilities to report a single
annual update per patient, we
encourage facilities to update this
information more frequently, in order to
more closely monitor their patients’ risk
factors, and to improve the quality of
the data.
Technical specifications for this
proposed measure can be found at
https://www.dialysisreports.org/pdf/esrd/
public-measures/ComorbidityReporting2016NPRM.pdf. We welcome comments
on these proposals.
Diabetes, on oral medications.
Diabetes, without medications.
Diabetic retinopathy.
Chronic obstructive pulmonary disease.
Tobacco use (current smoker).
Malignant neoplasm, Cancer.
Toxic nephropathy.
Alcohol dependence.
facilities to patients with ESRD. We are
considering the feasibility of developing
quality measures in other topic areas
(for example, blood transfusions, kidney
transplantation, quality of life, and
health information technology) for
quality improvement at the point of care
as well as for the electronic exchange of
information in support of care
coordination across providers and
settings. Additional areas of potential
interest include residual renal function,
complications associated with ESRD,
and frequently comorbid conditions (for
example, diabetes and heart disease).
We request comment on these potential
areas of future measurement, and
welcome suggestions on other topics for
measure development.
4. Other Measures Under Development
5. Proposed Scoring for the PY 2016
ESRD QIP and Future Payment Years
As part of our effort to continuously
improve the ESRD QIP, we continue to
work on developing additional robust
measures that provide valid assessments
of the quality of care furnished by
Section 1881(h)(3)(A)(i) of the Act
requires the Secretary to develop a
methodology for assessing the total
performance of each facility based on
the performance standards established
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00028
Fmt 4701
Sfmt 4702
Drug dependence.
Inability to ambulate.
Inability to transfer.
Needs assistance with daily activities.
Institutionalization—Assisted Living.
Institutionalization—Nursing Home.
Institutionalization—Other Institution.
Non-renal congenital abnormality.
with respect to the measures selected for
the performance period. We believe that
the methodology set forth in the CY
2013 ESRD PPS final rule incentivizes
facilities to meet the goals of the ESRD
QIP; therefore, with the exception of the
proposed changes further discussed in
the applicable section below, we are
proposing to adopt a scoring
methodology for the PY 2016 ESRD QIP
and future payment years that is nearly
identical to the one finalized in the CY
2013 ESRD PPS final rule. To the extent
that the scoring methodology differs,
those differences are proposed below.
6. Proposed Performance Period for the
PY 2016 ESRD QIP
Section 1881(h)(4)(D) of the Act
requires the Secretary to establish the
performance period with respect to a
year, and that the performance period
occur prior to the beginning of such
year. In the CY 2013 ESRD PPS final
rule, we finalized a performance period
of CY 2013. We stated our belief that, for
most measures, a 12-month performance
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
period is the most appropriate for the
program because this period accounts
for any potential seasonal variations that
might affect a facility’s score on some of
the measures, and also provides
adequate incentive and feedback for
facilities and Medicare beneficiaries.
For the reasons outlined in the CY 2013
ESRD PPS final rule (77 FR 67500), we
have determined for PY 2016 that CY
2014 is the latest period of time during
which we can collect a full 12 months
of data and still implement the payment
reductions beginning with renal dialysis
services furnished on January 1, 2016.
Therefore, for the PY 2016 ESRD QIP,
we are proposing to establish CY 2014
as the performance period for all of the
measures. We welcome comments on
this proposal.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
7. Proposed Performance Standards for
the PY 2016 ESRD QIP and Future
Payment Years
We are proposing to adopt
performance standards for the PY 2016
ESRD QIP measures that are similar to
what we finalized in the CY 2013 ESRD
PPS final rule. Section 1881(h)(4)(A)
provides that ‘‘the Secretary shall
establish performance standards with
respect to measures selected . . . for a
performance period with respect to a
year.’’ Section 1881(h)(4)(B) of the Act
further provides that the ‘‘performance
standards . . . shall include levels of
achievement and improvement, as
determined appropriate by the
Secretary.’’ We use the performance
standards to establish the minimum
score a facility must achieve to avoid a
Medicare payment reduction.
a. Proposed Clinical Measure
Performance Standards
For the same reasons stated in the CY
2013 ESRD PPS final rule (77 FR 67500
through 76502), we are proposing for PY
2016 to set the performance standards
(both achievement and improvement)
based on the national performance rate
(that is, the 50th percentile) of facility
performance in CY 2012, except as
specified below.
With respect to the proposed NHSN
Bloodstream Infection in Hemodialysis
Outpatients clinical measure, we are
proposing to begin data collection
beginning with CY 2014 events. We do
not have data prior to CY 2014 for
purposes of setting a performance
standard based on the national
performance rate of facility performance
in CY 2012. For that reason, we are
proposing that the performance
standard for the NHSN Bloodstream
Infection in Hemodialysis Outpatients
clinical measure for PY 2016 be the 50th
percentile of the national performance
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
rate on the measure during CY 2014.
Because we lack the baseline data
needed to calculate an improvement
score, we are also proposing that, for PY
2016, facilities be scored only on
achievement for this measure, and not
on the basis of improvement. Although
we recognize that with other measures
that lacked baseline data we instituted
a reporting measure to ensure that both
an achievement and improvement score
could be assessed, we believe that it is
appropriate, in this case, to adopt a
clinical measure without the baseline
data necessary for an improvement
score. Hospital Acquired Infections
(HAIs) are a leading cause of
preventable mortality and morbidity
across different settings in the
healthcare sector, including dialysis
facilities, costing patient lives and
billions of dollars. CMS has recognized
that reducing HAIs is critically
important to the Agency’s three main
goals of improving healthcare,
improving health, and reducing
healthcare costs. Because of the
abnormally great impact HAIs have
upon patients and the healthcare
industry, we believe it is important to
begin assessing facilities on the number
of these events as soon as possible,
rather than on merely whether they
report these events. Additionally, the
NHSN measure has been a reporting
measure since PY 2014, which will give
facilities two years to report data before
they are scored on the data results.
Thus, although we do not yet have
complete baseline data to give
improvement scores in PY 2016, we
believe it is appropriate to implement
this measure using only achievement
scores because of the urgency in
reducing these events and the time
facilities have had to prepare
themselves for such a measure. Finally,
we are proposing that facilities would
receive a score of zero on the NHSN
clinical measure if they do not submit
12 months of data, as defined in Section
III.C.3.d above, and by the deadlines
specified in Section III.C.3.d above.
For the proposed Patient Informed
Consent for Anemia Treatment, we
believe that facilities should meet the
standard 100 percent of the time.
However, we recognize that unexpected
events might make a 100 percent
standard difficult to meet, so we are
proposing that facilities should be
allowed to meet the standard for less
than 100 percent of their patients.
Because prior data are unavailable for
the establishment of a performance
standard, benchmark, and achievement
threshold, we developed a methodology
to determine appropriate achievement
PO 00000
Frm 00029
Fmt 4701
Sfmt 4702
40863
standards. As described in Section
III.C.10, we are proposing that a small
facility adjuster will be applied to
facilities with between 11 and 25
qualifying patients. Since facilities with
between 11 and 25 patients would be
subject to the favorable scoring
modifications applied by the small
facility adjuster, these facilities would
have an easier time achieving the
proposed achievement standards.
Therefore, the minimum number of
cases a facility may have and not benefit
from a small facility adjuster is 26. We
calculated that if a facility with 26 cases
failed to obtain consent for two
qualifying cases, it would have obtained
consent 92 percent of the time
(rounded). If the facility failed to obtain
consent for one case, it would have
obtained consent 96 percent of the time
(rounded). We believe that these values
(92 and 96 percent) encourage a high
consistency of care for patients with
ESRD that is reasonably attainable by all
facilities, while accounting for the
possibility that facilities would be
unable to obtain informed consent for
reasons beyond their control. Therefore,
we are proposing that the achievement
threshold be defined as obtaining
informed consent for 92 percent of
qualifying cases during the performance
period, and that the benchmark be
defined as obtaining informed consent
for 96 percent of such cases.
Furthermore, we propose to calculate
the proposed performance standard
using the average of the benchmark and
achievement threshold, which is 94
percent. We seek comments on this
performance standard.
Because we lack the baseline data
needed to calculate improvement scores
for the Patient Informed Consent for
Anemia Treatment measure, we are also
proposing that for PY 2016, facilities be
scored only on achievement for this
measure, and not on the basis of
improvement. We recognize that with
other measures that lacked baseline data
we adopted a reporting measure to
ensure that both an achievement and
improvement score could be assessed.
However, we believe that it is
appropriate, in this case, to adopt a
clinical measure without the baseline
data necessary for an improvement
score. Anemia management is a topic
highlighted in the ESRD QIP authorizing
statute, requiring measures that reflect
labeling approved by the Food and Drug
Administration. (See section
1881(h)(2)(A) of the Act.) The inclusion
of the topic in statue highlights its
importance to CMS and to dialysis
patients. ESA labeling has changed over
time as additional safety information
E:\FR\FM\08JYP2.SGM
08JYP2
40864
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
has become available, and the informed
consent process is designed to ensure
that the most current safety information
is communicated to patients before
ESAs are administered. In addition,
obtaining informed consent for anemia
treatment is a standard of practice that
should aready be in place at dialysis
facilities, so facilities should already
have procedures in place to support the
measure. Thus, although we do not yet
have complete baseline data to give
improvement scores in PY 2016, we
believe it is appropriate to implement
this measure using only achievement
scores because of the importance of
providing patients with current
information about the risks and benefits
of anemia therapy, and because this is
already a standard clinical practice.
For the proposed Hypercalcemia
measure, the first month that we can use
to establish the baseline is May 2012.
This is because the hypercalcemia
measure relies on CROWNWeb as its
data source, CROWNWeb was first
rolled out nationally in May 2012, and
data submitted to CROWNWeb before
that time is considered test or pilot data.
For that reason, we are proposing to set
the performance standard as the 50th
percentile of national performance from
May 2012 through November 2012. We
seek comment on this proposal.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
b. Estimated Performance Standards for
Proposed Clinical Measures
At this time, we do not have the
necessary data to assign numerical
values to the proposed performance
standards for the clinical measures,
because we do not yet have all of the
data from CY 2012 or the first portion
of CY 2013. However, we are able to
estimate these numerical values based
on the most recent data available. For all
of the proposed clinical measures
except Hypercalcemia, this data comes
from the period of January through
November 2012. For the Hypercalcemia
clinical measure, the most recent data
available comes from the period May
through November 2012. In Table 8, we
have provided the estimated
performance standards for all of the
measures except for the NHSN
Bloodstream Infection in Hemodialysis
Outpatients clinical measure, which
will be based on data from CY 2014. We
will publish updated values for all
measures except the NHSN Bloodstream
Infection in Hemodialysis Outpatients
clinical measure in the CY 2014 ESRD
PPS final rule.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
TABLE 8—ESTIMATED NUMERICAL VALUES FOR THE PERFORMANCE STANDARDS FOR THE PY 2016 ESRD QIP
CLINICAL MEASURES USING THE
MOST RECENTLY AVAILABLE DATA
Performance
standard
Measure
Vascular Access
Type:
%Fistula .................
%Catheter ..............
Kt/V:
Adult Hemodialysis
Adult, Peritoneal
Dialysis.
Pediatric Hemodialysis.
Anemia Management:
Hemoglobin > 12 g/
dL.
Patient Informed
Consent for Anemia Treatment 1.
Hypercalcemia ..........
NHSN Bloodstream
Infection in Hemodialysis Outpatients.
62.4%.
10.5%.
93.6%.
85.4%.
92.5%.
0%.
94%.
2.3%.
50th percentile of eligible facilities’ performance during
the performance
period.
1 As noted above, the performance standard
for the Patient Informed Consent for Anemia
Treatment is based on clinical standards, not
data collected through the ESRD QIP.
We believe that the ESRD QIP should
not have lower standards than in
previous years. In accordance with our
statements in the CY 2012 ESRD PPS
final rule (76 FR 70273), if the final
numerical values for the PY 2016
performance standards are worse than
PY 2015 for a measure, then we are
proposing to substitute the PY 2015
performance standard for that measure.
We request comments on this proposal.
c. Proposed Performance Standards for
Reporting Measures
For the proposed ICH CAHPS
reporting measure, we are proposing to
set the performance standard for PY
2016 as the facility’s successful
submission, by January 28, 2015, of ICH
CAHPS survey data collected during the
performance period in accordance with
the measure specifications to CMS as
specified at https://ichcahps.org. For PY
2017 and future payment years, we are
proposing that the PY 2016 performance
standard continue, except that in each
performance period, facilities are
required to submit data from the two
surveys conducted during the
performance period, rather than one,
and that the survey data must be
submitted by the dates specified by
CMS at https://ichcahps.org.
For the proposed Mineral Metabolism
reporting measure, we are proposing to
set the performance standard as
PO 00000
Frm 00030
Fmt 4701
Sfmt 4702
successfully reporting the measure for
the number of qualifying cases specified
in Section III.C.2.b for each month of the
12-month duration of the performance
period.
For the proposed Anemia
Management reporting measure, we are
proposing to set the performance
standard as successfully reporting the
measure for the number of qualifying
cases specified in Section III.C.2.c for
each month of the 12-month duration of
the performance period.
For the proposed Anemia
Management: Pediatric Iron Therapy
reporting measure, we are proposing to
set the performance standard as
successfully reporting for each
qualifying case each quarter the
following: (i) Patient admit/discharge
date; (ii) hemoglobin levels; (iii) serum
ferritin levels; (iv) TSAT percentages;
(v) the dates that the lab measurements
were taken for items (ii)–(iv); (vi)
intravenous IV iron prescribed or oral
iron prescribed (if applicable); and (vii)
the date that the IV iron or oral iron was
prescribed (if applicable).
For the proposed Comorbidity
reporting measure, we are proposing to
set the performance standard as
successfully updating in CROWNWeb at
least once during the performance
period for each qualifying case, the
patient’s comorbidities. We are further
proposing that the update be entered
into CROWNWeb by the January 31
following the conclusion of the
performance period or, if that is not a
regular business day, the first business
day thereafter.
8. Proposed Scoring for the PY 2016
ESRD QIP Proposed Measures
In order to assess whether a facility
has met the performance standards, we
finalized a methodology for the PY 2014
ESRD QIP under which we separately
score each clinical and reporting
measure. We score facilities based on an
achievement and improvement scoring
methodology for purposes of assessing
their performance on the clinical
measures (76 FR 70272 through 70273).
We are proposing to use a similar
methodology for purposes of scoring
facility performance on each of the
clinical measures for the PY 2016 ESRD
QIP and future payment years, except
that we are proposing that there will
only be an achievement score for the
NHSN Bloodstream Infection in
Hemodialysis Outpatients and Patient
Informed Consent for Anemia Treatment
clinical measures, because data are not
available to calculate an improvement
score.
In determining a facility’s
achievement score for the PY 2016
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
program and future payment years, we
are proposing to continue using the
current methodology described above,
under which facilities would receive
points along an achievement range
based on their performance during the
proposed performance period for each
measure, which we define as a scale
between the achievement threshold and
the benchmark explained below. We are
proposing to define the achievement
threshold for each of the proposed
clinical measures as the 15th percentile
of the national performance rate during
CY 2012, except as otherwise specified
below for the NHSN Bloodstream
Infection in Hemodialysis Outpatients
clinical measure, the Patient Informed
Consent for Anemia Treatment clinical
measure, and Hypercalcemia clinical
measure. We believe that this
achievement threshold will provide an
incentive for facilities to continuously
improve their performance, while not
reducing incentives to facilities that
score at or above the national
performance rate for the clinical
measures (77 FR 67503). We are
proposing to define the benchmark as
the 90th percentile of the national
performance rate during CY 2012,
except as proposed below for the NHSN
Bloodstream Infection in Hemodialysis
Outpatients clinical measure and the
Patient Informed Consent for Anemia
Treatment clinical measure, because it
represents a demonstrably high but
achievable standard of quality that the
high performing facilities reached.
For the proposed NHSN Bloodstream
Infection in Hemodialysis Outpatients
clinical measure, we are proposing that
the achievement threshold and
benchmark be the 15th and 90th
percentiles, respectively, of national
performance during CY 2014.
For the proposed Patient Informed
Consent for Anemia Treatment clinical
measure, and for the reasons described
in Section III.C.7.a, we are proposing
that the achievement threshold be
defined as obtaining informed consent
for 92 percent of qualifying cases during
the performance period, and that the
benchmark be defined as obtaining
informed consent for 96 percent of such
cases.
For the reasons described above, the
first month that we can use to establish
the baseline for the proposed
Hypercalcemia measure is May 2012.
Therefore, we are proposing to set the
achievement threshold as the 15th
percentile of national performance and
the benchmark as the 90th percentile of
national performance from May 2012
through November 2012. We request
comment on these proposals.
With the exception of the NHSN
Bloodstream Infection in Hemodialysis
Outpatients clinical measure and the
Patient Informed Consent Anemia
Treatment clinical measure, we are
proposing that facilities receive points
along an improvement range, defined as
a scale running between the
improvement threshold and the
benchmark. We are proposing to define
the improvement threshold as the
facility’s performance on the measure
during CY 2013. The facility’s
improvement score would be calculated
40865
by comparing its performance on the
measure during CY 2014 (the proposed
performance period) to its performance
rate on the measure during CY 2013.
Because we lack the baseline data
needed to calculate improvement scores
for the NHSN Bloodstream Infection in
Hemodialysis Outpatients clinical
measure and the Patient Informed
Consent for Anemia Treatment clinical
measure, we are proposing that facilities
will not receive improvement scores for
these measures for PY 2016.
Like the performance standards, we
do not have the necessary data at this
time to assign final numerical values to
the proposed achievement thresholds
and benchmarks for the clinical
measures. However, we are able to
estimate them based on the most recent
data available. For all of the clinical
measures except Hypercalcemia and
NHSN Bloodstream Infection in
Hemodialysis Outpatients, this data
comes from the period between January
2012 and November 2012. For the
Hypercalcemia clinical measure, the
data comes from the period between
May 2012 and November 2012. In Table
9, we have provided the estimated
achievement thresholds and
benchmarks for each of the measures
except for NHSN Bloodstream Infection
in Hemodialysis Outpatients clinical
measure (which would be based on data
from January 1, 2014 through December
31, 2104) and Patient Informed Consent
for Anemia Treatment (for which the
achievement threshold and benchmark
are proposed to be 92 percent and 96
percent, respectively).
TABLE 9—ESTIMATED PROPOSED ACHIEVEMENT THRESHOLDS AND BENCHMARKS FOR THE PROPOSED PY 2016 ESRD
QIP CLINICAL MEASURES USING THE MOST RECENTLY AVAILABLE DATA
Achievement threshold
%Fistula .............................................................
%Catheter ..........................................................
Kt/V:
Adult Hemodialysis .....................................
Adult, Peritoneal Dialysis ............................
Pediatric Hemodialysis ...............................
Anemia Management:
Hemoglobin > 12 g/dL .......................................
Patient Informed Consent for Anemia
Treatment 1.
Hypercalcemia ...................................................
NHSN Dialysis Event Reporting and Clinical
Bloodstream Infection.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Measure
Benchmark
49.8% ...............................................................
19.6% ...............................................................
77.1%.
3.0%.
85.9% ...............................................................
66.7% ...............................................................
83.3% ...............................................................
97.5%.
94.8%.
98.8%.
1.2% .................................................................
92% ..................................................................
0%.
96%.
6.1% .................................................................
15th percentile of eligible facilities’ performance during the performance period.
0.2%.
90th percentile of eligible facilities’ performance during the performance period.
1 As discussed above, the proposed achievement threshold and benchmark for the Patient Informed Consent for Anemia Treatment clinical
measure are based on clinical standards, not baseline data.
We believe that the ESRD QIP should
not have lower standards than previous
years. In accordance with our
statements in the CY 2012 ESRD PPS
final rule (76 FR 70273), if the final PY
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
2016 numerical values for the
achievement thresholds and
benchmarks are worse than PY 2015 for
a given measure, we are proposing to
substitute the PY 2015 achievement
PO 00000
Frm 00031
Fmt 4701
Sfmt 4702
thresholds and benchmarks for that
measure. We request comments on these
proposals.
E:\FR\FM\08JYP2.SGM
08JYP2
40866
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
reporting measure, using the following
formula:
Comorbidity reporting measure, we are
proposing that a facility receive a score
of 10 points if it satisfies the
performance standard for the measure,
and 0 points if it does not. We are
proposing to score these reporting
measures differently than the other
reporting measures because these
require annual or biannual reporting,
and therefore scoring based on monthly
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
Using this formula, a facility would
receive a score of 1 to 9 points for a
clinical measure based on a linear scale
distributing all points proportionately
between the achievement threshold and
the benchmark, so that the interval in
the performance between the score for a
given number of achievement points
and one additional achievement point is
the same throughout the range of
performance from the achievement
threshold to the benchmark.
b. Proposals for Scoring Facility
Performance on Clinical Measures
Based on Improvement
Using the same methodology we have
previously finalized for the ESRD QIP,
we are proposing that facilities would
earn between 0 and 9 points for each of
the clinical measures that will have an
improvement score (that is, all clinical
measures except NHSN Bloodstream
Infection in Hemodialysis Outpatients
clinical measure and Patient Informed
Consent for Anemia Treatment), based
on how much their performance on the
measure during CY 2014 improved from
their performance on the measure
during CY 2013 (77 FR 67504). A
specific improvement range for each
measure would be established for each
facility. We are proposing that if a
facility’s performance rate on a measure
during the performance period is:
PO 00000
Frm 00032
Fmt 4701
Sfmt 4702
[10 * ((Facility performance period rate
¥ Improvement threshold)/(Benchmark
¥ Improvement threshold))] ¥ .5, with
all scores rounded to the nearest integer,
with half rounded up.
Note that if the facility score is equal to
or greater than the benchmark, then it
would receive 10 points on the measure
based on the achievement score
methodology discussed above. We
request comments on this proposal.
c. Proposals for Calculating Facility
Performance on Reporting Measures
As noted above, reporting measures
differ from clinical measures in that
they are not scored based on clinical
values; rather, they are scored based on
whether facilities are successful in
achieving the reporting requirements
associated with each of these proposed
measures. The proposed criteria that
would apply to each reporting measure
are discussed below.
With respect to the proposed Anemia
Management reporting measure and the
proposed Mineral Metabolism reporting
measure, we are proposing to award
points to facilities using the same
formula that we finalized in the CY
2013 ESRD PPS final rule for Mineral
Metabolism and Anemia Management
(77 FR 67506):
or quarterly reporting rates is not
feasible.
We request comment on the proposed
methodology for scoring the PY 2016
ESRD QIP reporting measures.
E:\FR\FM\08JYP2.SGM
EP08JY13.001</GPH>
We are proposing to score the Pediatric
Iron Therapy measure differently than
the proposed Anemia Management
reporting measure and the proposed
Mineral Metabolism reporting measure
because it requires quarterly rather than
monthly reporting, and therefore scoring
based on monthly reporting rates is not
feasible.
With respect to the proposed ICH
CAHPS reporting measure and
• Less than the improvement
threshold, then the facility would
receive 0 points for improvement; or
• Equal to or greater than the
improvement threshold, but below the
benchmark, then the following formula
would be used to derive the
improvement score:
08JYP2
EP08JY13.000</GPH>
[9 * ((Facility’s performance period rate
¥ achievement threshold)/
(benchmark ¥ achievement
threshold))] + .5, with all scores
rounded to the nearest integer, with
half rounded up.
With respect to the proposed Use of
Iron Therapy for Pediatric Patients
tkelley on DSK3SPTVN1PROD with PROPOSALS2
a. Proposals for Scoring Facility
Performance on Clinical Measures
Based on Achievement
Using the same methodology we
finalized in the CY 2013 ESRD PPS final
rule, we are proposing to award between
0 and 10 points for each of the proposed
clinical measures (77 FR 67504). As
noted, we are proposing that the score
for each of these clinical measures will
be based upon the higher of an
achievement or improvement score on
each of the clinical measures, except for
NHSN Bloodstream Infection in
Hemodialysis Outpatients clinical
measure and the Patient Informed
Consent for Anemia Treatment clinical
measure, which we are proposing to
score on achievement alone. For
purposes of calculating achievement
scores for the clinical measures, we are
proposing to base the score on where a
facility’s performance rate falls relative
to the achievement threshold and the
benchmark for that measure.
(Performance standards do not enter
into the calculation of improvement or
achievement scores.) Identical to what
we finalized in the CY 2013 ESRD PPS
final rule, we are proposing that if a
facility’s performance rate during the
performance period is:
• Equal to or greater than the
benchmark, then the facility would
receive 10 points for achievement;
• Less than the achievement
threshold, then the facility would
receive 0 points for achievement; or
• Equal to or greater than the
achievement threshold, but below the
benchmark, then the following formula
would be used to derive the
achievement score:
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
9. Proposals for Weighting the PY 2016
ESRD QIP Measures and Calculating the
PY 2016 ESRD QIP Total Performance
Score
Section 1881(h)(3)(A)(iii) of the Act
provides that the methodology for
calculating the facility TPS shall
include a process to weight the
performance scores with respect to
individual measures to reflect priorities
for quality improvement, such as
weighting scores to ensure that facilities
have strong incentives to meet or exceed
anemia management and dialysis
adequacy performance standards, as
determined appropriate by the
Secretary. In determining how to
appropriately weight the PY 2016 ESRD
QIP measures for purposes of
calculating the TPS, we considered two
criteria: (1) The number of measures we
are proposing to include in the PY 2016
ESRD QIP; and (2) the National Quality
Strategy priorities.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
a. Weighting Individual Measures To
Compute Measure Topic Scores for the
Kt/V Dialysis Adequacy Measure Topic,
the Vascular Access Type Measure
Topic, and the Anemia Management
Clinical Measure Topic
In the CY 2013 ESRD PPS final rule,
we established a methodology for
deriving the overall scores for measure
topics (77 FR 67507). For the reasons
described in the CY 2013 ESRD PPS
final rule, we are proposing to use the
same methodology in PY 2016 and
future payment years to calculate the
scores for the three measure topics.
After calculating the individual measure
scores within a measure topic, we are
proposing to calculate a measure topic
score using the following steps: (i)
Dividing the number of patients in the
denominator of each measure by the
sum of the number of patients in each
denominator for all of the applicable
measures in the measure topic; (ii)
multiplying that figure by the facility’s
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
40867
score on the measure; (iii) summing the
results achieved for each measure; and
(iv) rounding this sum (with half
rounded up). We are proposing that if a
facility does not have enough patients to
receive a score on one of the measures
in the measure topic (as discussed
below), then that measure would not be
included in the measure topic score for
that facility. Only one measure within
the measure topic needs to have enough
cases to be scored in order for the
measure topic to be scored and included
in the calculation of the TPS. We are
also proposing that the measure topic
score would be equal to one clinical
measure in the calculation of the TPS.
For an additional explanation, see the
examples provided at 77 FR 67507.
We request comment on the proposed
method of weighting individual
measure scores to derive a measure
topic score.
number of cases with respect to one or
more of the measures or measure topics.
For the reasons stated in the CY 2013
ESRD PPS final rule, for PY 2016 and
future payment years, we are proposing
to continue to require a facility to have
at least one clinical and one reporting
measure score to receive a TPS (77 FR
67508). We request comment on our
proposals to require a facility to be
eligible for a score on at least one
reporting and one clinical measure in
order to receive a TPS.
Finally, we are proposing that the
TPSs be rounded to the nearest integer,
with half of an integer being rounded
up. We request comment on this
proposal. For further examples
regarding measure and TPS
calculations, we refer readers to the
figures below.
b. Proposal for Weighting the Total
Performance Score
In this section, we provide examples
to illustrate the proposed scoring
methodology for PY 2016. Figures 1–3
illustrate the scoring for a clinical
measure. Figure 1 shows Facility A’s
performance on an example clinical
measure. Note that for this example
clinical measure, the facility has
performed very well. The example
benchmark (the 90th percentile of
performance nationally in CY 2012)
calculated for this clinical measure is 77
percent, and the example achievement
threshold (which is the 15th percentile
of performance nationally in CY 2012)
is 46 percent. Therefore, facility A’s
performance of 86 percent on the
clinical measure during the performance
period exceeds the benchmark of 77
percent, so Facility A would earn 10
points (the maximum) for achievement
for this measure. (Because, in this
example, Facility A has earned the
maximum number of points possible for
this measure, its improvement score is
irrelevant.)
We continue to believe that weighting
the clinical measures/measure topics
equally will incentivize facilities to
improve and achieve high levels of
performance across all of these
measures, resulting in overall
improvement in the quality of care
provided to patients with ESRD. We
also continue to believe that, while the
reporting measures are valuable, the
clinical measures evaluate actual patient
outcomes and therefore justify a higher
combined weight (77 FR 67506 through
67508). For the reasons outlined in the
CY 2013 ESRD PPS final rule, we are
proposing to continue weighting clinical
measures as 75 percent and reporting
measures as 25 percent of the TPS. We
request comment on this proposed
methodology for weighting the clinical
and reporting measures.
We have also considered the issue of
awarding a TPS to facilities that do not
report data on the proposed minimum
PO 00000
Frm 00033
Fmt 4701
Sfmt 4702
c. Examples of the Proposed PY 2016
ESRD QIP Scoring Methodology
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Figure 2 shows an example of scoring
for another facility, Facility B. As
illustrated below, the facility’s
performance on the example clinical
measure improved from 26 percent in
CY 2013 to 54 percent during the
performance period. The achievement
threshold is 50 percent and the
achievement benchmark is 77 percent.
Because the facility’s performance
during the performance period is within
the achievement range and the
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
improvement range, we must calculate
the improvement and achievement
scores to determine the example clinical
measure score.
To calculate the achievement score,
we would apply the formula discussed
above. The result of this formula for this
example is [9 * ((54¥50)/(77¥50))] + .5,
which equals 1.83, and we round to the
nearest integer, which is 2.
Likewise, to calculate the
improvement score, we apply the
improvement formula discussed above.
PO 00000
Frm 00034
Fmt 4701
Sfmt 4702
The result of this formula for this is
example is [10 * ((54¥26)/
(77¥26))]¥.5, which equals 4.99 and
we round to the nearest integer, which
is 5.
Therefore, for this example clinical
measure, Facility B’s achievement score
is 3, and its improvement score is 5. We
award Facility B the higher of the two
scores for this clinical measure. Thus,
Facility B’s score on this example
measure is 5.
E:\FR\FM\08JYP2.SGM
08JYP2
EP08JY13.002</GPH>
40868
40869
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
Figure 2
Benchmark
Ii '1 II II 1
a
,
¥"
54-
9 X
,
=1.83, rounded to 2
+0.5
11-50
= Achievement Threshold
(15th percentile)
=Benchmark (10th percentile)
7
II
=4.99, rounded to
. :--"-.
!.
= Improvement Thl1l8hold
(2013 performance rate)
tkelley on DSK3SPTVN1PROD with PROPOSALS2
=Benchmark (10th percentile)
BILLING CODE 4120–01–P
In Figure 3, Facility C’s performance
on the example clinical measure drops
from 26 percent in CY 2013 to 23
percent during the performance period,
a decline of 3 percent. Because Facility
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
11l1s facIlity will earn a VAT - Fi.stula measure scor~~of1
t
~~-"~""'---~""-''''"~-~'.-'''''''''-""",.,..,..",-,,,"--'.~"'''--
based on
as the higher score derived
~m
I the two scoring methods.
----_.
C’s performance during the performance
period falls below the achievement
threshold of 26 percent, it receives 0
points for achievement. Facility C also
receives 0 points for improvement
because its performance during the
PO 00000
Frm 00035
Fmt 4701
Sfmt 4702
.~
performance period was lower than its
performance during CY 2013. Therefore,
in this example, Facility C would
receive 0 points for the example clinical
measure.
E:\FR\FM\08JYP2.SGM
08JYP2
EP08JY13.003</GPH>
r~--·-·-
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
The method illustrated above would
be applied to each clinical measure in
order to obtain a score for each measure.
Scores for reporting measures are
calculated based upon their individual
criteria, as discussed earlier.
After calculating the scores for each
measure, we would calculate the TPS.
As an example, by applying the
weighting criteria to a facility that
receives a score on all finalized
measures, we would calculate the
facility’s TPS using the following
formula:
Total Performance Score = [(.150 *
Vascular Access Type Measure
Topic) + (.150 * Kt/V Dialysis
Adequacy Measure Topic) + (.150 *
Anemia Management Clinical
Measure Topic) + (.150 *
Hypercalcemia Measure) + (.150 *
NHSN Bloodstream Infection in
Hemodialysis Outpatients) + (.05 *
ICH CAHPS Survey Reporting
Measure) + (.05 * Mineral
Metabolism Reporting Measure) +
(.05 * Anemia Management
Reporting Measure) + (.05 *
Pediatric Iron Therapy Reporting
Measure) + (.05 * Comorbidity
Reporting Measure) ] * 10.
The TPS would be rounded to the
nearest integer (and any individual
measure values ending in .5 would be
rounded to the next higher integer).
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
However, if, for example, a facility
did not receive a score (that is, did not
have enough qualifying cases) on the
proposed Hypercalcemia measure, then
the facility’s TPS would be calculated as
follows:
Total Performance Score = [(.188 *
Vascular Access Type Measure
Topic) + (.188 * Kt/V Dialysis
Adequacy Measure Topic) + (.188 *
Anemia Management Clinical
Measure Topic) + (.188 * NHSN
Bloodstream Infection in
Hemodialysis Outpatients) + (.05 *
ICH CAHPS Survey Reporting
Measure) + (.05 * Mineral
Metabolism Reporting Measure) +
(.05 * Anemia Management
Reporting Measure) + (.05 *
Pediatric Iron Therapy Reporting
Measure) + (.05 * Comorbidity
Reporting Measure) ] * 10.
Again, the TPS would be rounded to the
nearest integer (and any individual
measure values ending in .5 would be
rounded to the next higher integer).
Finally, for example, if a facility is
eligible for only two of the reporting
measures, then the facility’s TPS would
be calculated as follows:
Total Performance Score = [(.150 *
Vascular Access Type Measure
Topic) + (.150 * Kt/V Dialysis
Adequacy Measure Topic) + (.150 *
Anemia Management Cinical
PO 00000
Frm 00036
Fmt 4701
Sfmt 4702
Measure Topic) + (.150 *
Hypercalcemia Measure) + (.150 *
NHSN Bloodstream Infection in
Hemodialysis Outpatients) + (.125 *
Anemia Management Reporting
Measure) + (.125 * Comorbidity
Reporting Measure)] * 10.
Again, the TPS would be rounded to the
nearest integer (and any individual
measure values ending in .5 would be
rounded to the next higher integer).
10. Proposed Minimum Data for Scoring
Measures for the PY 2016 ESRD QIP and
Future Payment Years
For the same reasons described in the
CY 2013 ESRD PPS final rule (77 FR
67510 through 67512), for PY 2016 and
future payment years, we are proposing
to only score facilities on clinical and
reporting measures for which they have
a minimum number of qualifying cases
during the performance period. For PY
2016 and future payment years, we are
proposing that a facility must have a
threshold of at least 11 qualifying cases
for the entire performance period in
order to be scored on a clinical measure.
We are proposing that reporting
measures other than ICH CAHPS will
have a threshold of one qualifying case
during the performance period. The 11qualifying case minimum was intended
to reduce burden on facilities with
limited qualifying cases for earlier
E:\FR\FM\08JYP2.SGM
08JYP2
EP08JY13.004</GPH>
tkelley on DSK3SPTVN1PROD with PROPOSALS2
40870
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
reporting measures (77 FR 67480,
67483, 67486 and 67493). We are
proposing to set the reporting measure
case minimums at one because we plan
to use data to permit future
implementation of clinical measures. If
patients in small facilities are
systematically excluded, then we will
not be able to gather the robust data we
need to support the performance
standard, benchmark, and achievement
threshold calculations in future
payment years. For example, if we
excluded facilities with 10 or fewer
patients from the Pediatric Iron Therapy
reporting measure, then very few, if any,
facilities would be able to report the
measure, and we would be unable to
collect meaningful data for future
measure development. Similarly, if we
excluded facilities with 10 or fewer
patients from the comorbidity reporting
measure, then we would be unable to
use updated comorbidities for patients
in these facilities in a risk-adjusment
calculation should we propose to adopt
an SHR and/or SMR clinical measure in
the future. For those reasons, we are
proposing that the case minimum for all
reporting measures except for ICH
CAHPS be one.
For the proposed expanded ICH
CAHPS reporting measure, we are
proposing that facilities with fewer than
30 qualifying cases during the
performance period not be scored on the
measure. In the CY 2013 ESRD PPS final
rule, we excluded facilities with 10 or
fewer adult in-center hemodialysis
patients from the ICH CAHPS measure
because we recognized that, for many
small dialysis facilities, hiring a thirdparty administrator to fulfill the ICH
CAHPS survey requirements would
have been impractical or prohibitively
costly (77 FR 67480). As we move
toward developing a clinical measure,
we have determined that the survey
results are more reliable if there are at
least 30 surveys submitted per facility.
Therefore, we are proposing that for PY
2016 and future payment years,
facilities that treat fewer than 30
qualifying cases (defined as adult incenter hemodialysis patients) during the
performance period will be excluded
from this measure. We further are
proposing that we will consider a
facility to have met the 30-patient
threshold unless it affirmatively attests
in CROWNWeb by January 31 of the
year prior to the year in which payment
reductions will be made (for example,
January 31, 2015, for the PY 2016 ESRD
QIP) that it treated 29 or fewer adult incenter hemodialysis patients during the
performance period.
For the same reasons described in the
CY 2013 ESRD PPS final rule (77 FR
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
67510 through 67512), for PY 2016 and
future payment years, we are proposing
to apply to each clinical measure score
for which a facility has between 11 and
25 qualifying cases the same adjustment
factor we finalized in the CY 2013 ESRD
PPS final rule (77 FR 67511). We seek
public comment on these proposals.
For the PY 2016 ESRD QIP and future
payment years, we are also proposing to
continue to begin counting the number
of months or quarters, as applicable, for
which a facility is open on the first day
of the month after the facility’s CCN
open date. With the exception of the
ICH CAHPS expanded reporting
measure, we are proposing that only
facilities with a CCN open date before
July 1, 2014, be scored on the proposed
reporting measures. Under the
specifications for the proposed ICH
CAHPS reporting measure, facilities
would need to administer the survey
(via a CMS-approved, third-party
vendor) during the performance period.
Because arranging such an agreement
takes time, we are proposing that only
facilities with a CCN open date before
January 1 of the performance period to
be scored on this measure. Additionally,
we are proposing that facilities with
CCN open dates after January 1, 2014
will not be scored on the NHSN. We
note that in previous payment years we
have awarded partial credit to facilities
that submitted less than 12 months of
data to encourage them to enroll in and
report data in the NHSN system.
However, we are proposing to collect 12
months of data on this clinical measure
because infection rates vary through
different seasons of the year.
As discussed above, we are proposing
that a facility will not receive a TPS
unless it receives a score on at least one
clinical and one reporting measure. We
note that finalizing this proposal would
result in facilities not being eligible for
a payment reduction for the PY 2016
ESRD QIP and future payment years if
they have a CCN open date on or after
July 1 of the performance period (CY
2014 for the PY 2016 ESRD QIP). We
request comment regarding these
proposals.
11. Proposed Payment Reductions for
the PY 2016 ESRD QIP and Future
Payment Years
Section 1881(h)(3)(A)(ii) of the Act
requires the Secretary to ensure that the
application of the scoring methodology
results in an appropriate distribution of
payment reductions across facilities,
such that facilities achieving the lowest
TPSs receive the largest payment
reductions. For PY 2016, we are
proposing that a facility would not
receive a payment reduction if it
PO 00000
Frm 00037
Fmt 4701
Sfmt 4702
40871
achieves a minimum TPS that is equal
to or greater than the total of the points
it would have received if: (i) It
performed at the performance standard
for each clinical measure; (ii) it received
zero points for each clinical measure
that did not have a numerical value for
the performance standard published
with the PY 2016 final rule; and (iii) it
received five points for each reporting
measure. We request comments on these
proposals.
Section 1881(h)(3)(A)(ii) of the Act
requires that facilities achieving the
lowest TPSs receive the largest payment
reductions. For PY 2016 and future
payment years, we are proposing that
the payment reduction scale be the same
as the PY 2015 ESRD QIP (77 FR 67514
through 67516). We are proposing that,
for each 10 points a facility falls below
the minimum TPS, the facility would
receive an additional 0.5 percent
reduction on its ESRD PPS payments for
PY 2016 and future payment years, with
a maximum reduction of 2.0 percent. As
we stated in the CY 2012 ESRD PPS
final rule, we believe that such a sliding
scale will incentivize facilities to meet
the performance standards established
and continue to improve their
performance; even if a facility fails to
achieve the minimum TPS, such a
facility will still be incentivized to
strive for and attain better performance
rates in order to reduce the percentage
of its payment reduction (76 FR 70281).
We request comments on the proposed
payment reduction scale.
Because we are not yet able to
calculate the performance standards for
each of the clinical measures, we are
also not able to calculate the minimum
TPS at this time. Based on the estimated
performance standards listed above
using the most recent data available, we
estimate for PY 2016 that a facility must
meet or exceed a minimum TPS of 46.
For all of the clinical measures except
Hypercalcemia, this data comes from
the period between January 2012 and
November 2012. For the Hypercalcemia
clinical measure, the data comes from
the period between May 2012 and
November 2012. We are proposing that
facilities failing to meet the minimum
TPS (as will be published in the
Medicare Program; End-Stage Renal
Disease Prospective Payment System,
Quality Incentive Program, and Durable
Medical Equipment, Prosthetics,
Orthotics, and Supplies final rule in
November) will receive payment
reductions based on the estimated total
performance score ranges indicated in
Table 10 below.
E:\FR\FM\08JYP2.SGM
08JYP2
40872
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
TABLE 10—ESTIMATED PAYMENT REDUCTION SCALE FOR PY 2016
BASED ON THE MOST RECENTLY
AVAILABLE DATA
Total performance score
Reduction
(Percent)
tkelley on DSK3SPTVN1PROD with PROPOSALS2
100–46 * ................................
45–36 ....................................
35–26 ....................................
25–16 ....................................
15–0 ......................................
0
0.5
1.0
1.5
2.0
12. Data Validation
One of the critical elements of the
ESRD QIP’s success is ensuring that the
data submitted to calculate measure
scores and TPSs are accurate. We began
a pilot data-validation program in CY
2013 for the ESRD QIP, and we are now
in the process of procuring the services
of a data-validation contractor, who will
be tasked with validating a national
sample of facilities’ records as they
report CY 2013 data to CROWNWeb.
The first priority will be to develop a
methodology for validating data
submitted to CROWNWeb under the
pilot data-validation program; once this
methodology has been developed, CMS
will publicize it through a CROWN
Memo and solicit public comment. As
part of the CY 2013 ESRD QIP PPS final
rule (77 FR 67522 through 67523), we
finalized a requirement to sample
approximately 10 records from 750
randomly selected facilities; these
facilities will have 60 days to comply
once they receive requests for records.
We are proposing to extend this pilot
data-validation program to include
analysis of data submitted to
CROWNWeb during CY 2014. For the
PY 2016 ESRD QIP, sampled facilities
will be reimbursed by our validation
contractor for the costs associated with
copying and mailing the requested
records. Additionally, we are proposing
to reduce the annual random sample
size from 750 to 300. We believe that
this smaller sample size will still yield
a sufficiently precise estimate of QIP
reliability while imposing a smaller
burden on ESRD QIP-eligible facilities
and CMS alike. We are also proposing
to extend our policy that no facility will
receive a payment reduction resulting
from the validation process for CY 2014
during PY 2016. Once we have gathered
additional information based on these
initial validation efforts, we will
propose further procedures for
validating data submitted in future years
of the ESRD QIP. These procedures may
include a method for scoring facilities
based on the accuracy of the data they
submit to CROWNWeb, and a method to
assign penalties for submitting
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
inaccurate data. We solicit comments on
these proposals.
We are also considering a feasibility
study for validating data reported to
CDC’s NHSN Dialysis Event Module,
which may mirror the process used by
the Hospital Inpatient Quality Reporting
Program (77 FR 53539 through 53553).
Although this is still in the early stages
of development, we anticipate that this
study may mirror the validation sample
by targeting ‘‘candidate HAI events,’’
much like the methodology used by
CMS’s Hospital Inpatient Quality
Reporting Program. The feasibility study
will likely: (i) Estimate the burden and
associated costs to ESRD QIP-eligible
facilities for participating in an NHSN
validation program; (ii) assess the costs
to CMS to implement an NHSN
validation program on a statistically
relevant scale; and (iii) develop and test
a protocol to validate NHSN data in
nine ESRD QIP-eligible facilities.
Facilities would be selected on a
voluntary basis. Based on the results of
this study, we intend to propose more
detailed requirements for validating
NHSN data used in the ESRD QIP in the
future.
13. Proposals for Scoring Facilities
Whose Ownership Has Changed
During PY 2012 (our first
implementation year for the ESRD QIP),
facilities requested guidance regarding
how a change in ownership affects any
applicable ESRD QIP payment
reductions. Starting with the
implementation of the PY 2015 ESRD
QIP (which is CY 2013), the application
of an ESRD QIP payment reduction
depended on whether the facility
retained its CCN after the ownership
transfer. If the facility’s CCN remained
the same after the facility was
transferred, then we considered the
facility to be the same facility (despite
the change in ownership) for the
purposes of the ESRD QIP, and we
applied any ESRD QIP payment
reductions that would have applied to
the transferor to the transferee.
Likewise, as long as the facility retained
the same CCN, we calculated the
measure scores using the data submitted
during the applicable period, regardless
of whether the ownership changed
during one of these periods. If, however,
a facility received a new CCN as a result
of a change in ownership, then we
treated the facility as a new facility for
purposes of the ESRD QIP based on the
new facility’s CCN open date. We
believe that these proposals are the most
operationally efficient and will allow
facilities the greatest amount of
certainty when they change ownership.
We are proposing to continue applying
PO 00000
Frm 00038
Fmt 4701
Sfmt 4702
these rules during the PY 2016 ESRD
QIP and future years of the program,
and we request public comment on this
proposal.
14. Proposals for Public Reporting
Requirements
Section 1881(h)(6)(A) of the Act
requires the Secretary to establish
procedures for making information
available to the public about facility
performance under the ESRD QIP,
including information on the TPS (as
along with appropriate comparisons of
facilities to the national average with
respect to such scores) and scores for
individual measures achieved by each
facility. Section 1881(h)(6)(B) of the Act
further requires that a facility have an
opportunity to review the information to
be made public with respect to that
facility prior to publication. In addition,
section 1881(h)(6)(C) of the Act requires
the Secretary to provide each facility
with a certificate containing its TPS to
post in patient areas within the facility.
Finally, section 1881(h)(6)(D) of the Act
requires the Secretary to post a list of
facilities and performance-score data on
a CMS Web site.
In the PY 2012 ESRD QIP final rule,
we adopted uniform requirements based
on sections 1881(h)(6)(A) through
1881(h)(6)(D) of the Act, thereby
establishing procedures for facilities to
review the information to be made
public and for informing the public
through facility-posted certificates. We
are proposing to maintain the public
reporting requirements as finalized in
the CY 2013 ESRD PPS final rule, except
regarding the timing of when facilities
must post their certificates.
For PYs prior to PY 2014, we required
facilities to post certificates within 5
business days of us making these
certificates available for download from
dialysisreports.org in accordance with
section 1881(h)(6)(C) of the Act. (77 FR
67516 and 76 FR 637) In the CY 2013
ESRD PPS final rule, we noted that
many individuals responsible for
posting the certificates were away on
holiday during the December time
period when certificates typically
become available, and finalized that,
beginning in PY 2014, a facility must
post copies of its certificates by the first
business day after January 1 of the
payment year. (77 FR 67517) We also
noted that certificates are typically
available for download on or around
December 15 of each year, and stated
that we believe that this two week time
is enough to allow facilites to post them.
Since the CY 2013 ESRD PPS final
rule was finalized, we have noted that
a posting deadline of the first business
day after January 1 could create
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
difficulties for facilities if it were ever
the case that certificates were not
available for download in the typical
timeframe. We want to ensure that
facilities have adequate time to post
certificates as required in this
circumstance, and that the required
timing accommodates the December
holidays. Therefore, we propose that,
beginning in PY 2014, facilities must
post certificates within fifteen business
days of us making these certificates
available for download from
dialysisreports.org in accordance with
section 1881(h)(6)(C) of the Act. We
request comments on this proposal.
IV. Clarification of the Definition of
Routinely Purchased Durable Medical
Equipment (DME)
tkelley on DSK3SPTVN1PROD with PROPOSALS2
A. Background
1. Background for DME
Title XVIII of the Social Security Act
(the Act) governs the administration of
the Medicare program. The statute
provides coverage for broad categories
of benefits, including, but not limited to,
inpatient and outpatient hospital care,
skilled nursing facility care, home
health care, physician services, and
DME. ‘‘Medical and other health
services,’’ which is defined under
section 1861(s)(6) of the Act to include
DME, is a separate Medicare Part B
benefit for which payment is authorized
by section 1832 of the Act. In
accordance with section 1861(n) of the
Act, the term ‘‘durable medical
equipment’’ includes iron lungs, oxygen
tents, hospital beds, and wheelchairs
used in the beneficiary’s home,
including an institution used as his or
her home other than an institution that
meets the requirements of section
1861(e)(1) or section 1819(a)(1) of the
Act.
Section 1834(a) of the Act, as added
by section 4062 of the Omnibus Budget
Reconciliation Act of 1987 (OBRA 87),
Public Law 100–203, sets forth the
payment rules for DME furnished on or
after January 1, 1989. The Medicare
payment amount for a DME item is
generally equal to 80 percent of the
lesser of the actual charge or the fee
schedule amount for the item, less any
unmet Part B deductible. The
beneficiary’s coinsurance for such items
is generally equal to 20 percent of the
lesser of the actual charge or the fee
schedule amount for the item once the
deductible is met. The fee schedule
amounts are generally calculated using
average allowed charges from a base
period and then increased by annual
update factors. Sections 1834(a)(2)
through (a)(7) of the Act set forth
separate classes of DME and separate
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
payment rules for each class. The six
classes of items are: inexpensive and
other routinely purchased DME; items
requiring frequent and substantial
servicing; customized items; oxygen and
oxygen equipment; other covered items
(other than DME); and other items of
DME, also referred to as capped rental
items. The class for inexpensive and
other routinely purchased DME also
includes accessories used in
conjunction with nebulizers, aspirators,
continuous positive airway pressure
devices and respiratory assist devices.
Items of DME fall under the class for
other items of DME (capped rental
items) if they do not meet the
definitions established in the statute
and regulations for the other classes of
DME.
2. Medicare Guidance and Rulemaking
Regarding Definition of Routinely
Purchased DME
On July 14, 1988, CMS central office
issued a program memorandum to the
CMS regional offices containing
guidance for carriers to follow in
developing a data base that would be
used in identifying other routinely
purchased DME for the purpose of
implementing section 1834(a)(2)(a)(ii) of
the Act. For the purpose of identifying
routinely purchased items, the carriers
were instructed via the program
memorandum to ‘‘compute the
unduplicated count of beneficiaries who
purchased the item, by HCPCS code,
and a count of those who only rented
the item during the 7/1/86–6/30/87
period.’’ The carriers were instructed to
include purchase of new and used items
and beneficiaries who purchased an
item that was initially rented in the
count of beneficiaries who purchased
the item. The carriers made
determinations regarding whether DME
furnished during this period would be
rented (non-capped) or purchased based
on which payment method was more
economical.
In November 1988, CMS revised Part
3 (Claims Process) of the Medicare
Carriers Manual (HCFA Pub. 14–3) via
transmittal number 1279, by adding
section 5102 and detailed instructions
for implementation of the fee schedules
and payment classes for DME mandated
by section 4062 of OBRA 87. The new
implementing instructions were
effective for services furnished on or
after January 1, 1989. Section 5102.1
indicated that carriers would be
provided with a listing of the HCPCS
(Health Care Financing Administration
Common Procedure Coding System
prior to 2003 and Healthcare Common
Procedure Coding System beginning in
2003) codes for the equipment in the
PO 00000
Frm 00039
Fmt 4701
Sfmt 4702
40873
routinely purchased DME category. The
initial classifications were implemented
on January 1, 1989, in accordance with
the program instructions, and included
a listing of HCPCS codes for base
equipment such as canes and walkers,
as well as HCPCS codes for replacement
accessories such as cane tips, walker leg
extensions, and power wheelchair
batteries for use with medically
necessary, patient-owned base
equipment (canes, walkers, and power
wheelchairs). In the case of expensive
accessories that were not routinely
purchased during July 1986 through
June 1987, such as a wheelchair
attachment to convert any wheelchair to
one arm drive, these items fell under the
listing of HCPCS codes for capped rental
items. Medicare payment for DME
extends to payment for replacement of
essential accessories used with patientowned equipment or accessories,
attachments, or options that modify base
equipment, such as the addition of
elevating leg rests to a manual
wheelchair.
The Medicare definition of routinely
purchased equipment is under 42 CFR
§ 414.220(a)(2) and specifies that
routinely purchased equipment means
equipment that was acquired by
purchase on a national basis at least 75
percent of the time during the period
July 1986 through June 1987.’’ This
definition was promulgated via an
interim final rule (IFC) on December 7,
1992 (57 FR 57698), remaining
consistent with Medicare program
guidance in effect beginning in 1988
and discussed above, and finalized on
July 10, 1995 (60 FR 35492). In the
preamble of the 1992 IFC (57 FR 57679),
we discussed how items were classified
as routinely purchased DME based on
data from July 1986 through June 1987,
‘‘in the absence of a statutory directive
that defines the period for determining
which items are routinely purchased.’’
CMS indicated that it ‘‘selected the
period July 1, 1986 through June 30,
1987, because it is the same 12-month
period required by section
1834(a)(2)(B)(i) of the Act for calculating
the base fee schedule amount for
routinely purchased equipment.’’ This
period was therefore established as the
period from which data was used for
identifying the items that had been
acquired on a purchase basis 75 percent
of the time or more under the Medicare
rent/purchase program.
3. Payment for Inexpensive or Routinely
Purchased Items and Capped Rental
Items
Pursuant to 42 CFR § 414.220(b)
payment for inexpensive or routinely
purchased DME is made on a purchase
E:\FR\FM\08JYP2.SGM
08JYP2
40874
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
or rental basis, with total payments
being limited to the purchase fee
schedule amount for the item. If an item
is initially rented and then purchased,
the allowed purchase charge is based on
the lower of the actual charge or fee
schedule amount for purchase of the
item minus the cumulative allowed
charge for previously paid rental claims.
Pursuant to 42 CFR § 414.229(f),
payment for capped rental items is
made on a monthly rental basis for up
to 13 months of continuous use. The
supplier must transfer title to the
equipment to the beneficiary on the first
day following the 13th month of
continuous use.
B. Current Issues
Concerns have been raised about the
application of the definition of and
payment for routinely purchased DME,
as it applies to expensive DME
accessories. For example, recently one
manufacturer of a new, expensive
wheelchair accessory, included under a
HCPCS code that would result in a
corresponding Medicare fee schedule
amount of approximately $3,000, if
purchased, questioned why the HCPCS
code describing their product was
classified as capped rental DME. They
pointed out that codes added to the
HCPCS in recent years for other similar
and more expensive wheelchair
accessories costing $4,000 to $10,000
were classified as routinely purchased
DME even though the items were not
purchased under Medicare during the
period specified in § 414.220(b). As a
result, we began a review of expensive
items that have been classified as
routinely purchased equipment since
1989, that is, new codes added to the
HCPCS after 1989 for items costing more
than $150, to address this apparent
inconsistency.
As a result of this review, we found
some codes that are not classified
consistent with the regulatory definition
of routinely purchased equipment at
section § 414.220(a)(2). We found that
HCPCS codes added after 1989 for
expensive, durable accessories used
with base equipment, such as
wheelchairs, have been classified as
routinely purchased equipment. While
section 1834(a)(2)(A)(iii) of the Act and
42 CFR § 414.220(a)(3) of the regulations
allow payment for the purchase of
accessories used in conjunction with
nebulizers, aspirators, continuous
positive airway pressure devices
(CPAP), other items covered under the
DME benefit including DME other than
nebulizers, aspirators, CPAP devices,
respiratory assist devices and
accessories used in conjunction with
those items, are paid for in accordance
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
with the rules at section 1834(a) of the
Act and are classified under sections
1834(a)(3) thru (7) of the Act as
inexpensive and other routinely
purchased DME, items requiring
frequent and substantial servicing,
certain customized items, oxygen and
oxygen equipment, other covered items
other than DME, or other covered items
of DME.
Additionally, we found that in some
cases, expensive items of DME were
classified as routinely purchased based
on information suggesting that payers
other than Medicare were routinely
making payment for the items on a
purchase basis. We believe that
classifying an item as routinely
purchased equipment based on data and
information from other payers for the
purposes of implementing § 414.220(b)
is inappropriate because other payers do
not operate under the same payment
rules as Medicare. Other payers may
decide to purchase expensive items for
reasons other than a achieving a more
economical alternative to rental, the
basis Medicare contractors used in
deciding whether to purchase items
during July 1986 through June 1987. In
other cases, expensive items of DME
were classified as routinely purchased
equipment based on requests from
manufacturers of equipment primarily
used by Medicaid beneficiaries. We do
not believe we should classify an item
as routinely purchased equipment for
the purposes of implementing
§ 414.220(b) of the Medicare regulations
based on how this might affect other
payers such as Medicaid state agencies
because such classifications are not
consistent with the regulations, which
for Medicare purposes generally require
payment on a capped rental basis for
any item with a purchase cost of greater
than 150 dollars. After reviewing this
issue, we do not think the regulation
supports the classification of expensive
DME as routinely purchased equipment
based solely on whether other payers
routinely pay for the item on a purchase
basis or how manufacturers would
prefer that other payers pay for the item.
The classification of HCPCS codes for
expensive equipment added after 1989
as routinely purchased equipment based
on this kind of information does not
comply with the Medicare definition of
routinely purchased equipment and
defeats a fundamental purpose of the
capped rental payment methodology to
avoid paying the full purchase price of
costly equipment used only a short
time.
DME and accessories used in
conjunction with DME are paid for
under the DME benefit and in
accordance with the rules at section
PO 00000
Frm 00040
Fmt 4701
Sfmt 4702
1834(a) of the Act. We are clarifying the
existing definition of routinely
purchased equipment at § 414.220(a)(2)
and providing notice that certain
HCPCS codes for DME and DME
accessories added to the HCPCS after
1989 that are currently classified as
routinely purchased equipment should
be reclassified as capped rental items
(see Table 11 below). This applies to all
expensive items for which Medicare
claims data July 1986 through June 1987
does not exist or does not indicate that
the item was acquired by purchase on
a national basis at least 75 percent of the
time. In the case of expensive
accessories that are furnished for use
with complex rehabilitative power
wheelchairs, the purchase option for
complex rehabilitative power
wheelchairs at section 1834(a)(7)(A)(iii)
of the Act would also apply to these
accessories. For any wheelchair
accessory classified as a capped rental
item and furnished for use with a
complex rehabilitiave power wheelchair
(that is, furnished to be used as part of
the complex rehabilitative power
wheelchair), the supplier must give the
beneficiary the option of purchasing
these accessories at the time they are
furnished. These items would be
considered as part of the complex
rehabilitative power wheelchair and
associated purchase option set forth at
§ 414.229(a)(5).
We are soliciting comments on the
effective date(s) for reclassifying items
previously classified as routinely
purchased equipment to the capped
rental payment class in order to be in
compliance with current regulations.
Given that some items (HCPCS codes)
may be included in the Round 2 and/
or Round 1 Recompete phases of the
competitive bidding program, we do not
believe we can change the classification
for items furnished under these
programs until the contracts awarded
based on these competitions expire on
July 1, 2016, and January 1, 2017,
respectively, regardless of whether the
item is provided in an area subject to
competitive bidding or not. We propose
that the reclassification of items
previously classified as routinely
purchased equipment to the capped
rental payment class be effective
January 1, 2014, for all items that are not
included in either a Round 2 or Round
1 Recompete competitive bidding
program (CBP) established in
accordance with § 414.400. For any item
currently under a Round 2 CBP, instead
of a January 1, 2014, effective date we
propose July 1, 2016, for these
reclassifications, which would apply to
all items furnished in all areas of the
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
country, with the exception of items
furnished in a Round 1 Recompete CBP.
For items furnished in a Round 1
Recompete CBP, we propose an effective
date of January 1, 2017, which would
only apply to items furnished in the
nine Round 1 Recompete areas.
Therefore, we propose to generally base
the effect dates on when the competitive
bidding programs end. To summarize,
the proposed effective dates for the
reclassifications of these items from the
routinely purchased DME class to the
capped rental DME class would be:
• January 1, 2014, for items furnished
in all areas of the country if the item is
not included in Round 2 or Round 1
Recompete CBP;
• July 1, 2016, for items furnished in
all areas of the country if the item is
included in a Round 2 CBP and not a
Round 1 Recompete CBP and for items
included in a Round 1 Recompete CBP
but furnished in an area other than one
of the 9 Round 1 Recompete areas; and
• January 1, 2017, for items included
in a Round 1 Recompete CBP and
furnished in one of the nine Round 1
Recompete areas.
With the exception of the items
described in the fourth bullet, this
implementation strategy would allow
the item to be moved to the payment
class for capped rental items at the same
time in all areas of the country without
disrupting CBPs currently underway.
For Round 1 Recompete items furnished
in nine areas of the country for the sixmonth period from July 1, 2016, thru
December 31, 2016, Medicare payment
would be on a capped rental basis in all
parts of the country other than these
nine areas.
Alternatively, the effective date for
the reclassifications could be January 1,
2014, for all items paid under the fee
schedule. In other words, the
reclassification would not affect
payments for items furnished under the
Round 2 or Round 1 Recompete CBPs in
the respective CBAs until the contract
entered into under these programs
expire on July 1, 2016, and January 1,
2017, respectively. However, this
alternative would result in an extensive
two and a half year period from Janary
2014 through June 2016, where
Medicare payment would be on a
capped rental basis for the items in half
of the country (non-competitive bidding
areas) and on a purchase basis in the
other half of the country (109 Round 2
and/or Round 1 Recompete competitive
bidding areas). We believe that this
bifurcation in payment classifications
would create confusion and would be
difficult to implement, and we are
soliciting comments on this alternative
implementation strategy.
We have identified approximately 80
HCPCS codes requiring reclassification
from the inexpensive or routinely
purchased DME payment class to the
capped rental DME payment class. The
codes are shown in Table 11 below. The
impacts of our changes are included in
the discussion of impacts in section X
of this rule.
As shown in Table 11, Column A of
the table shows the type of DME.
Columns B and C indicate the HCPCS
level II codes and the short descriptor.
The long descriptor for each code is
available at https://www.cms.gov/
Medicare/Coding/
HCPCSReleaseCodeSets/AlphaNumeric-HCPCS.html.
As shown in Column A, the majority
of codes relate to manual wheelchairs
and wheelchair accessories. In the case
of accessories that are only used with
complex rehabilitative power
wheelchairs classified as capped rental
items, the purchase option for complex
rehabilitative power wheelchairs
applies to these accessories because
they are part of the capped rental
wheelchair that the supplier is required
to offer to the beneficiary on a lump
sum purchase basis. We have displayed
in Column B the items that would be
associated with the purchase option set
forth at section § 414.229(a)(5).
Wheelchair accessories that are also
used with manual wheelchairs or
standard power wheelchairs would also
be subject to the purchase option if they
are furnished for use with a complex
rehabilitative power wheelchair.
TABLE 11—ROUTINELY PURCHASED ITEMS RECLASSIFIED TO CAPPED RENTAL
Group category
HCPCS
Automatic External Defibrillator .................................................
Canes/Crutches .........................................................................
Glucose Monitor ........................................................................
High Frequency Chest Wall Oscillation Device (HFCWO) .......
Hospital Beds/Accessories ........................................................
Misc. DMEPOS ..........................................................................
K0607 ...............
E0117 ...............
E0620 ...............
A7025 ...............
E0300 ...............
A4639 ...............
E0762 ...............
E1700 ...............
K0730 ...............
E0760 ...............
E0740 ...............
E0764 ...............
E0656 ...............
E0657 ...............
E0984 ...............
E0457 ...............
E2500 ...............
E2502 ...............
E2504 ...............
E2506 ...............
E2508 ...............
E2510 ...............
E0197 * .............
E0198 ...............
E0849 ...............
E0855 ...............
E0856 ...............
E0140 * .............
E0144 ...............
E0149 * .............
E1161 ...............
Nebulizers & Related Drugs ......................................................
Osteogenesis Stimulator ...........................................................
Other Neuromuscular Stimulators .............................................
Pneumatic Compression Device ...............................................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Power Operated Vehicles (POV) ..............................................
Respiratory Equipment ..............................................................
Speech Generating Devices ......................................................
Support Surfaces .......................................................................
Traction Equipment ...................................................................
Walkers ......................................................................................
Wheelchairs Manual ..................................................................
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00041
Fmt 4701
Sfmt 4702
40875
Descriptor
Repl battery for AED.
Underarm spring assist crutch.
Capillary blood skin piercing device laser.
Replace chest compress vest.
Enclosed ped crib hosp grade.
Infrared ht sys replacement pad.
Trans elec jt stim dev sys.
Jaw motion rehab system.
Ctrl dose inh drug deliv system.
Osteogenesis ultrasound stimulator.
Incontinence treatment system.
Functional neuromuscular stimulation.
Segmental pneumatic trunk.
Segmental pneumatic chest.
Add pwr tiller.
Chest shell.
SGD digitized pre-rec <=8min.
SGD prerec msg >8min <=20min.
SGD prerec msg >20min <=40min.
SGD prerec msg > 40 min.
SGD spelling phys contact.
SGD w multi methods messg/access.
Air pressure pad for mattress.
Water pressure pad for mattress.
Cervical pneum traction equip.
Cervical traction equipment.
Cervical collar w air bladder.
Walker w trunk support.
Enclosed walker w rear seat.
Heavy duty wheeled walker.
Manual adult wc w tiltinspac.
E:\FR\FM\08JYP2.SGM
08JYP2
40876
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
TABLE 11—ROUTINELY PURCHASED ITEMS RECLASSIFIED TO CAPPED RENTAL—Continued
Group category
HCPCS
Wheelchairs Options/Accessories .............................................
Wheelchairs Seating ..................................................................
E1232 ...............
E1233 ...............
E1234 ...............
E1235 ...............
E1236 ...............
E1237 ...............
E1238 ...............
E0985 * .............
E0986 ...............
E1002 ∧ .............
E1003 ∧ .............
E1004 ∧ .............
E1005 ∧ .............
E1006 ∧ .............
E1007 ∧ .............
E1008 ∧ .............
E1010 ∧ .............
E1014 ...............
E1020 * .............
E1028 * .............
E1029 ...............
E1030 ∧ .............
E2227 ...............
E2228 * .............
E2310 ∧ .............
E2311 ∧ .............
E2312 ∧ .............
E2313 ∧ .............
E2321 ∧ .............
E2322 ∧ .............
E2325 ∧ .............
E2326 ∧ .............
E2327 ∧ .............
E2328 ∧ .............
E2329 ∧ .............
E2330 ∧ .............
E2351 ∧ .............
E2368 * .............
E2369 * .............
E2370 * .............
E2373 ...............
E2374 ∧ .............
E2375 * .............
E2376 ∧ .............
E2377 ∧ .............
E2378 ...............
K0015 * .............
K0070 * .............
E0955 * .............
Descriptor
Folding ped wc tilt-in-space.
Rig ped wc tltnspc w/o seat.
Fld ped wc tltnspc w/o seat.
Rigid ped wc adjustable.
Folding ped wc adjustable.
Rgd ped wc adjstabl w/o seat.
Fld ped wc adjstabl w/o seat.
W/c seat lift mechanism.
Man w/c push-rim pow assist.
Pwr seat tilt.
Pwr seat recline.
Pwr seat recline mech.
Pwr seat recline pwr.
Pwr seat combo w/o shear.
Pwr seat combo w/shear.
Pwr seat combo pwr shear.
Add pwr leg elevation.
Reclining back add ped w/c.
Residual limb support system.
W/c manual swingaway.
W/c vent tray fixed.
W/c vent tray gimbaled.
Gear reduction drive wheel.
Mwc acc, wheelchair brake.
Electro connect btw control.
Electro connect btw 2 sys.
Mini-prop remote joystick.
PWC harness, expand control.
Hand interface joystick.
Mult mech switches.
Sip and puff interface.
Breath tube kit.
Head control interface mech.
Head/extremity control interface.
Head control interface nonproportional.
Head control proximity switch.
Electronic SGD interface.
Pwr wc drivewheel motor replace.
Pwr wc drivewheel gear box replace.
Pwr wc dr wh motor/gear comb.
Hand/chin ctrl spec joystick.
Hand/chin ctrl std joystick.
Non-expandable controller.
Expandable controller, replace.
Expandable controller, initial.
Pw actuator replacement.
Detach non-adjus hght armrst.
Rear whl complete pneum tire.
Cushioned headrest.
* Effective July 1, 2016. If the item is furnished in CBAs in accordance with contracts entered into as part of the Round 1 Recompete of
DMEPOS CBP, then effective January 1, 2017.
∧ Item billable with Complex Rehabilitative Power Wheelchair codes K0835–K0864.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
In summary, we are providing notice
of certain HCPCS codes that would be
reclassified as capped rental items (see
Table 11 of codes). We invite comments
on this section.
V. Clarification of the 3-Year Minimum
Lifetime Requirement (MLR) for DME
DME is covered by Medicare based, in
part, upon section 1832(a) of the Act,
which describes the scope of benefits
under the supplementary medical
insurance program (Medicare Part B), to
include ‘‘medical and other health
services,’’ which is further defined
VerDate Mar<15>2010
18:07 Jul 05, 2013
Jkt 229001
undersection 1861(s)(6) of the Act to
include DME. In addition, section
1861(m)(5) of the Act specifically
includes DME in the definition of the
term ‘‘home health services.’’ In
accordance with section 1861(n) of the
Act, the term ‘‘durable medical
equipment’’ includes iron lungs, oxygen
tents, hospital beds, and wheelchairs
used in the patient’s home whether
furnished on a rental basis or
purchased. The patient’s home includes
an institution used as his or her home
other than an institution that meets the
requirements of section 1861(e)(1) or
PO 00000
Frm 00042
Fmt 4701
Sfmt 4702
section 1819(a)(1) of the Act. Besides
being subject to this provision, the
coverage of DME must meet the
requirements of section 1862(a)(1)(A) of
the Act, which in general excludes from
payment any items or services that are
not reasonable and necessary for the
diagnosis or treatment of illness or
injury or to improve the functioning of
a malformed body member, and section
1862(a)(6) of the Act, which (except for
certain specified exceptions) precludes
payment for personal comfort items.
Section 414.202 defines DME as
equipment furnished by a supplier or a
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
home health agency that meets the
following conditions: (1) Can withstand
repeated use; (2) effective with respect
to items classified as DME after January
1, 2012, has an expected life of at least
3 years; (3) is primarily and customarily
used to serve a medical purpose; (4)
generally is not useful to an individual
in the absence of an illness or injury;
and is appropriate for use in the home.
Prior to 2012, the definition for DME
did not contain a 3-year minimum
lifetime requirement (MLR) although
Section 110.1 of chapter 15 of the
Medicare Benefit Policy Manual (CMSPub. 100–02) provided further guidance
with regard to the definition of DME
and durability of an item that is when
an item is considered durable.
B. Current Issues
On November 10, 2011, CMS issued a
final rule in which it revised the
definition of DME at § 414.200 by
adding a 3-year MLR effective January 1,
2012, that must be met by an item or
device in order to be considered durable
for the purpose of classifying the item
under the Medicare benefit category for
DME (76 FR 70228 (November 10,
2011)). Specifically, an additional
condition under § 414.200 is that DME
must be equipment furnished by a
supplier or a home health agency that,
effective with respect to items classified
as DME after January 1, 2012, has an
expected life of at least 3 years. The
change to the regulation was designed to
further clarify the meaning of the term
‘‘durable’’ and provide an interpretation
of the statute generally consistent with
the DME payment and coverage
provisions, including, Medicare
program guidance at section 280.1 of
chapter 1, part 4 of the Medicare
National Coverage Determinations
Manual (Pub. 100–03) which specifies
that an item can withstand repeated use
means that the item could normally be
rented and used by successive patients.
The 3-year MLR is intended to specify
that durable equipment is equipment
that can withstand repeated use over an
extended period of time. Since the vast
majority of items covered under the
DME benefit over the years last for 3 or
more years, the MLR is intended to
clarify the scope of the DME benefit
primarily for new items coming on the
market or in the process of being
developed. The standard set forth in
regulations gives manufacturers and the
public a clear understanding of how
long an item would need to withstand
repeated use in order the meet the
durability requirement for DME. The
rule also provides clear guidance to
CMS and other stakeholders for making
consistent informal benefit category
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
determinations and national coverage
determinations for DME.
The 3-year MLR is designed to
represent a minimum threshold for a
determination of durability for a piece
of equipment. The 3-year MLR is not an
indication of the typical or average
lifespan of DME, which in many cases
is far longer than 3 years. The 3-year
MLR does not apply to disposable
supplies or accessories covered for use
with DME such as masks, tubing, and
blood glucose test strips. The 3-year
MLR is prospective only and does not
apply to equipment classified as DME
before the regulation was effective, that
is, January 1, 2012.
We also determined that the 3-year
MLR should not apply to equipment
classified as DME before the effective
date to allow for continued coverage of
such equipment that healthcare industry
and beneficiaries have come to rely on,
regardless of whether those items met
the 3-year MLR set forth at 42 CFR
414.202 (76 FR 70288). Given that
reliance, we did not intend to reopen
those prior decisions and reclassify the
equipment in light of the 3-year
standard. We believe that continuing
Medicare coverage for items that
qualified as DME prior to the effective
date, helps avoid disrupting the
continuity of care for the beneficiaries
that received these items for medical
treatment prior to January 1, 2012.
Beneficiaries have been relying on
these items for their treatment to the
extent that the items have been covered
as DME under Medicare and applying
the 3-year MLR to these items could
impact the continuity of care for these
beneficiaries. Furthermore, we believed
that a vast majority of the categories of
items that were classified as DME before
January 1, 2012, did function for 3 or
more years. We also noted that the 3year durability rule would only apply to
new products, and, to the extent that a
modified product is not a new product,
the 3-year MLR would not be
applicable.
In response to the public comments
that requested further clarification on
the application of the grandfathering
provision for the 3-year MLR, we noted
that we would consider issuing
additional guidance to provide further
clarification, if necessary (76 FR 70290).
For purposes of providing additional
guidance on the scope of the
grandfathered items under the
provision, we invite public comments
on this issue.
C. Scope of the 3-Year MLR for DME
Under § 414.202, effective with
respect to items classified as DME after
January 1, 2012, an item is not
PO 00000
Frm 00043
Fmt 4701
Sfmt 4702
40877
considered durable unless it has an
expected life of at least 3 years.
Therefore, the 3-year MLR applies to
new items after January 1, 2012, and
does not apply to items covered under
the DME benefit on or prior to January
1, 2012. Items classified as DME on or
before January 1, 2012, are considered
‘‘grandfathered items’’ for the purpose
of this requirement, regardless of
whether they meet the 3-year rule.
For the purpose of providing further
guidance on the scope of the 3-year
MLR, we are providing clarification
about how we would regard
grandfathered items covered as DME
prior to the effective date and we
request comments on that clarification.
If the product is modified (upgraded,
refined, reengineered, etc.) after January
1, 2012, the item would still be
classified as DME as a grandfathered
item unless the modified product now
has an expected life that is shorter than
the expected lifetime for the item
covered as DME prior to January 1,
2012, In this case, we consider the item,
as modified, to be a new item that is
subject to the 3-year MLR. For example,
equipment covered prior to January 1,
2012, and described by code X has a life
of at least 2 years. If, after January 1,
2012, that item is modified such that it
no longer lasts 2 years, such
modification would render the item
‘‘new’’ and it would be subject to the 3year MLR. Therefore, since the new
(modified) product does not last 3 years,
it would not meet the definition of DME
under the regulation and could not be
covered or be billed using the code that
described the item before it was
modified.
We seek comments on this proposed
clarification.
VI. Implementation of Budget-Neutral
Fee Schedules for Splints, Casts and
Intraocular Lenses (IOLs)
A. Background
1. Payment Under Reasonable Charges
Payment for most items and services
furnished under Part B of the Medicare
program is made through contractors
known as Medicare Administrative
Contractors (MACs). These contractors
were previously referred to as carriers.
Prior to 1988, in accordance with
section 1842(b) of the Act, payment for
most of these items and services was
made on a reasonable charge basis by
these contractors, with the criteria for
determining reasonable charges set forth
at 42 CFR part 405, subpart E of our
regulations.
Under this general methodology,
several factors or ‘‘charge screens’’ were
developed for determining the
E:\FR\FM\08JYP2.SGM
08JYP2
40878
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
reasonable charge for an item or service.
In accordance with § 405.503, each
supplier’s ‘‘customary charge’’ for an
item or service, or the 50th percentile of
charges for an item or service over a 12month period, was one factor used in
determining the reasonable charge. In
accordance with § 405.504, the
‘‘prevailing charge’’ in a local area, or
the 75th percentile of suppliers’
customary charges for the item in the
locality, was also used in determining
the reasonable charge. For the purpose
of calculating prevailing charges, a
‘‘locality’’ is defined at § 405.505 of our
regulations and ‘‘may be a State
(including the District of Columbia, a
territory, or a Commonwealth), a
political or economic subdivision of a
State, or a group of States.’’ The
regulation further specifies that the
locality ‘‘should include a cross section
of the population with respect to
economic and other characteristics.’’ In
accordance with § 405.506, for certain
items, such as parenteral and enteral
nutrients, supplies, and equipment, an
additional factor referred to as the
‘‘lowest charge level’’ was used in
determining the reasonable charge for
an item or service. In accordance with
section 5025 of the Medicare Carriers
Manual (HCFA Pub. 14–3) and
§ 405.509 of our regulations, effective
for items furnished on or after October
1, 1985, an additional factor, the
‘‘inflation-indexed charge (IIC),’’ was
added to the factors taken into
consideration in determining the
reasonable charge for certain items and
services. The IIC is defined in
§ 405.509(a) as the lowest of the fee
screens used to determine reasonable
charges for items and services,
including supplies, and equipment
reimbursed on a reasonable charge basis
(excluding physicians’ services) that is
in effect on December 31 of the previous
fee screen year, updated by the inflation
adjustment factor. The inflation
adjustment factor is based on the
current percentage change in the
consumer price index for all urban
consumers (United States city average)
(CPI–U) for the 12-month period ending
June 30. The reasonable charge is
generally set based on the lowest of the
actual charge for the item or service or
the factors described above.
2. Payment Under Fee Schedules
Specific provisions have been added
to the Act mandating replacement of the
reasonable charge payment
methodology with fee schedules for
most items and services furnished under
Part B of the Medicare program. The
phase in of fee schedules to replace
reasonable charges for Medicare
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
payment purposes began with the fee
schedule for clinical diagnostic
laboratory tests in 1988. As of 1997,
very few items and services were still
paid on a reasonable charge basis,
which is a very time consuming and
laborious process. Contractors must
collect new charge data each year,
perform the various calculations, and
maintain pricing files and claims
processing edits for the various charge
screens. For each item that is paid on a
reasonable charge basis, administrative
funding must be provided to contractors
for the purpose of performing these
calculations and maintaining these
pricing files. Therefore, replacing
reasonable charge payments with fee
schedules eliminates the need to fund
these efforts and saves money that can
be used to implement other parts of the
program. Section 4315 of the Balanced
Budget Act of 1997 (BBA) amended the
Act at section 1842 by adding a new
subsection (s). Section 1842(s) of the Act
provides authority for implementing
statewide or other area wide fee
schedules to be used for payment of the
following services that were previously
on a reasonable charge basis:
• Medical supplies.
• Home dialysis supplies and
equipment (as defined in section
1881(b)(8) of the Act).
• Therapeutic shoes.
• Parenteral and enteral nutrients,
equipment, and supplies (PEN).
• Electromyogram devices.
• Salivation devices.
• Blood products.
• Transfusion medicine.
For Medicare payment purposes, we
interpret the category ‘‘medical
supplies’’ under section 1842(s) of the
Act to include all other items paid on
a reasonable charge basis as of 1997 that
do not fall under any of the other
categories listed in section 1842(s) of the
Act. We believe that section 1842(s) of
the Act is intended to provide authority
for establishing fee schedules for all of
the remaining, and relatively small
number of items and services still paid
for on a reasonable charge basis at the
time of enactment in 1997. In light of
this provision, we generally consider
‘‘intraocular lenses’’ to be paid as
‘‘medical supplies.’’ Therefore, in
addition to including splints and casts
under this category, we also propose to
include intraocular lenses inserted in a
physician’s office for the purpose of
implementing this specific section.
Although we recognize the terms
‘‘intraocular lenses’’ and ‘‘medical
supplies’’ are separately identified
under § 414.202, we note that such
terms are listed for purposes of defining
what constitutes orthotic and prosthetic
PO 00000
Frm 00044
Fmt 4701
Sfmt 4702
devices (that is, these terms are
excluded from such definition), and not
intended to suggest these are mutually
exclusive things. Accordingly, we do
not believe we are precluded from
establishing fee schedules for IOLs
under the category of medical supplies
under section 1842(s) of the Act.
Nevertheless, we are specifically
requesting comments on this issue.
Section 1842(s)(1) of the Act provides
that the fee schedules for the services
listed above are to be updated on an
annual basis by the percentage increase
in the CPI–U (United States city
average) for the 12-month period ending
with June of the preceding year, reduced
by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II)
of the Act. Total payments for the initial
year of the fee schedules must be
budget-neutral, or approximately equal
to the estimated total payments that
would have been made under the
reasonable charge payment
methodology. As explained below, we
used this authority to establish fee
schedules for parental and enteral
nutrition (PEN) items and services for
use in paying claims with dates of
service on or after January 1, 2002.
On July 27, 1999, we published a
notice of proposed rulemaking (64 FR
40534) to establish fee schedules for
PEN items and services, splints and
casts, intraocular lenses (IOLs) inserted
in a physician’s office, and various other
items and services for which section
1842(s) of the Act provided authority for
replacing the reasonable charge
payment methodology with fee
schedules. After reviewing public
comments on the proposed rule, we
decided to move ahead with a final rule
establishing fee schedules for the
Parenteral and Enteral Nutrition (PEN)
items and services, but not the other
items and services, primarily related to
concerns regarding data used for
calculating fee schedule amounts for
items and service that are no longer paid
on a reasonable charge basis. The final
rule for implementing the fee schedules
for PEN items and services was
published on August 28, 2001 (66 FR
45173). For splints and casts, national
reasonable charge amounts, updated on
an annual basis by the IIC, have been
used to pay for the splint and cast
materials. Converting these amounts to
national fee schedule amounts that are
updated by the same index factor used
in updating the reasonable charge
amounts would result in no change in
payment, or 100 percent budgetneutrality. Currently, very few IOLs are
inserted in a physician’s office
nationally. In 2011, total allowed
charges for 437 IOLs furnished to 287
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
beneficiaries equaled $75,914. Since
IOLs are considerably low volume items
furnished by very few suppliers
nationally, there are some states where
none of these items are furnished;
therefore, charge data for use in
calculating prevailing charges, even at
the state level, are not available and
budget-neutrality is not an issue. If the
national average allowed amount for
these items is used as the fee schedule
amount for the few IOLs that are still
inserted in a physician’s office, we do
not believe that total allowed charges in
the first year of the fee schedule would
be significantly different than what
would otherwise be paid nationally
under the current reasonable charge
payment methodology. For 2011, the
national average allowed charge for
covered claims for the 287 beneficiaries
receiving IOLs inserted in a physician’s
office was $174 ($75,914 ÷ 437). In some
cases, the allowed charge for specific
claims in 2011 was less than $174 and
in other cases the allowed charge was
more than $174. However, given the low
volume of items furnished nationally,
the budget impact of paying all of the
approximately 437 claims based on the
national average allowed amount would
be negligible. We believe establishing
budget-neutral fee schedule amounts for
splints and casts, and IOLs inserted in
a physician’s office will save
government resources in calculating the
reasonable charge payment for the low
volume items. We are proposing to
establish fee schedules for these items
effective for paying claims with dates of
service on or after January 1, 2014.
B. Provisions of the Proposed
Regulations
For the reasons we articulated above,
we propose, under section 1842(s) of the
Act, to implement fee schedules for
splints and casts, and IOLs inserted in
a physician’s office falling under the
category of medical supplies. In
addendum C of this proposed rule, we
have inserted the current 2013
reasonable charge amounts for splints,
casts and IOLs inserted in a physician’s
office. The splints and casts are
payment amount limits updated by the
CPI–U factor ending with June of the
preceding year, in this case June 2012.
The IOLs inserted in physician’s office
estimates the 2012 average allowed
charge. We would not have the entire
calendar year estimates for 2013 average
allowed charge for IOLs inserted in a
physician’s office in order to implement
the fee schedule amounts for these items
effective for paying claims with dates of
service on or after January 1, 2014;
therefore, we are using the estimate of
the 2012 average allowed charge. The
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
final fee schedule amount will be
specified in the final rule. We currently
do not have the percentage change in
the CPI–U for the 12-month period
ending with June of 2013 to update the
fee-schedule amounts for splints and
casts. Specifically, we are proposing to
amend 42 CFR § 414.106 and § 414.100
to include the general rule for updating
the fee schedules for splints, casts and
IOLs inserted in a physician’s office. We
are also proposing to add § 414.106 and
§ 414.108 to set forth the fee schedule
methodology and updates as explained
above for splints, casts, and IOLs
inserted in a physician’s office. Subject
to coinsurance and deductible rules,
Medicare payment for these services is
to be equal to the lower of the actual
charge for the item or the amount
determined under the applicable fee
schedule payment methodology.
For splints and casts, we propose
national fee schedule amounts for items
furnished from January 1, 2014, thru
December 31, 2014, based on 2013
reasonable charges updated by the
percentage increase in the consumer
price index for all urban consumers
(United States city average) for the 12month period ending with June 2013.
For subsequent years, the fee schedule
amounts would be updated by the
percentage increase in the consumer
price index for all urban consumers
(United States city average) for the 12month period ending with June of the
preceding year, reduced by the
productivity adjustment as described in
section 1886(b)(3)(B)(xi)(II) of the Act.
For IOLs inserted in a physician’s
office, we propose national fee schedule
amounts for items furnished from
January 1, 2014, thru December 31,
2014, based on the national average
allowed charge for the item from
January 1, 2012 through December 31,
2012, updated by the percentage
increase in the consumer price index for
all urban consumers (United States city
average) for the 24-month period ending
with June 2013. For subsequent years,
the fee schedule amounts would be
updated by the percentage increase in
the consumer price index for all urban
consumers (United States city average)
for the 12-month period ending with
June of the preceding year, reduced by
the productivity adjustment as
described in section 1886(b)(3)(B)(xi)(II)
of the Act.
VII. DMEPOS Technical Amendments
and Corrections
A. Background
Medicare pays for various DMEPOS
items and services based on payment
rules that are set forth in section 1834
PO 00000
Frm 00045
Fmt 4701
Sfmt 4702
40879
of the Act and 42 CFR Part 414, Subpart
D. We propose to make three minor,
conforming technical amendments to
the existing DMEPOS payment
regulations (the title of Subpart D and
42 CFR § 414.200 and § 414.226).
B. Proposed Technical Amendments
and Corrections
Below are the proposed technical
amendments.
• We propose to modify the title of
‘‘Subpart D—Payment for Durable
Medical Equipment, Prosthetic and
Orthotic Devices’’ to read ‘‘Subpart D—
Payment for Durable Medical
Equipment, Prosthetic and Orthotic
Devices, and Surgical Dressings’’ to
reflect that payment for surgical
dressings is addressed under this
subpart at § 414.220(g).
• In subpart § 414.200, we propose to
modify the phrase ‘‘This subpart
implements sections 1834 (a) and (h) of
the Act by specifying how payments are
made for the purchase or rental of new
and used durable medical equipment
and prosthetic and orthotic devices for
Medicare beneficiaries.’’ as follows:
‘‘This subpart implements sections 1834
(a),(h), and (i) of the Act by specifying
how payments are made for the
purchase or rental of new and used
durable medical equipment, prosthetic
and orthotic devices, and surgical
dressings for Medicare beneficiaries.’’
The Omnibus Budget Reconciliation Act
of 1993 amended section 1834 of the
Act by adding subsection (i), mandating
payment on a fee schedule basis for
surgical dressings. Although
§ 414.220(g) addresses this requirement,
the regulation at § 414.200 was not
updated to indicate that this subpart
implements section 1834(i) in addition
to sections 1834(a) and (h) of the Act.
• Section 1834(a)(9)(D) of the Act
provides authority for creating separate
classes of oxygen and oxygen
equipment. Section 1834(a)(9)(D)(ii) of
the Act prohibits CMS from creating
separate classes of oxygen and oxygen
equipment that result in expenditures
for any year that are more or less than
expenditures which would have been
made if the separate classes had not
been created. In other words, the new
classes and payment amounts for
oxygen and oxygen equipment must be
established so that creating the new
classes is annually budget-neutral. In
November 2006, we published a final
rule establishing separate classes for
oxygen and oxygen equipment and
included a methodology for meeting the
requirements of section 1834(a)(9)(D)(ii)
of the Act by applying annual
reductions to the monthly fee schedule
amounts for the stationary oxygen
E:\FR\FM\08JYP2.SGM
08JYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
40880
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
equipment class at § 414.226(c)(1)(i) in
order to establish budget neutrality for
total oxygen and oxygen expenditures
for all oxygen classes. Increases in
expenditures for oxygen and oxygen
equipment that are attributed to higher
payment amounts established for new
classes of oxygen and oxygen equipment
are off set by reducing the monthly
payment amount for stationary oxygen
equipment. Due to a drafting error in the
regulation text portion of the November
2006 final rule, CMS–1304–F (71 FR
65933), 42 CFR § 414.226(c)(6) needs to
be corrected. The regulation text at
§ 414.226(c)(6) mistakenly states that
budget neutrality should be achieved by
adjusting all oxygen class rates. Section
414.226(c)(6) should read that only the
stationary oxygen equipment rate
should be adjusted to achieve budget
neutrality. Therefore, we propose that
§ 414.226(c)(6) be revised to read as
follows: ‘‘Beginning in 2008, CMS
makes an annual adjustment to the
national limited monthly payment rate
for items described in paragraph (c)(1)(i)
of this section to ensure that such
payment rates do not result in
expenditures for any year that are more
or less than the expenditures that would
have been made if such classes had not
been established.’’
• We are also making a technical
correction to existing 42 CFR
§ 414.102(c) to conform the regulation
governing parenteral and enteral (PEN)
nutrients, equipment and supplies
covered item fee schedule update with
the statute. Although section
1842(s)(1)(B)(ii) of the Act is selfimplementing, the PEN nutrients,
equipment and supplies payment
regulations at 42 CFR 414 Subpart C
were not updated to reflect the
application of the multifactor
productivity adjustment to the CPI–U
update factor for 2011 and subsequent
calendar years. Therefore, we are
revising § 414.102(c) of our regulations
to specify that for years 2003 through
2010, the PEN items and services fee
schedule amounts of the preceding year
are updated by the percentage increase
in the CPI–U for the 12-month period
ending with June of the preceding year.
For each year subsequent to 2010, the
PEN items and services fee schedule
amounts of the preceding year are
updated by the percentage increase in
the CPI–U for the 12-month period
ending with June of the preceding year,
reduced by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II)
of the Act.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
VIII. Collection of Information
Requirements
A. Legislative Requirement for
Solicitation of Comments
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day 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. In order to fairly evaluate
whether an information collection
requirement should be approved by
OMB, section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995
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 estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
B. Requirements in Regulation Text
In section II.D. of this proposed rule,
we are proposing changes to regulatory
text for the ESRD PPS in CY 2014.
However, the changes that are being
proposed do not impose any new
information collection requirements.
C. Additional Information Collection
Requirements
This proposed rule does not impose
any new information collection
requirements in the regulation text, as
specified above. However, this proposed
rule does make reference to several
associated information collections that
are not discussed in the regulation text
contained in this document. The
following is a discussion of these
information collections.
1. ESRD QIP
a. Proposed Expanded ICH CAHPS
Reporting Measure for PY 2016 and
Future Payment Years of the ESRD QIP
As stated above in section III.C.2.a of
this proposed rule, we proposed to
include in the PY 2016 ESRD QIP an
expanded ICH CAHPS reporting
measure, which assesses facility usage
of the ICH CAHPS survey. Unlike the
ICH CAHPS reporting measure finalized
in the CY 2013 ESRD PPS final rule (77
FR 67480 through 67481), the proposed
expanded ICH CAHPS reporting
measure would require facilities to
report (via a CMS-approved vendor)
survey data to CMS once for PY 2016,
PO 00000
Frm 00046
Fmt 4701
Sfmt 4702
and, for PY 2017 and beyond, to
administer (via a CMS-approved
vendor) a second ICH CAHPS survey
and report the second set of survey data
to CMS. Therefore, for PY 2016, we
estimate the burden associated with this
requirement to be the time and effort
necessary for facilities to submit (via a
CMS-approved vendor) survey results to
CMS. For PY 2017 and future payment
years, we estimate the burden associated
with this requirement is the time and
effort necessary for facilities to
administer (via a CMS-approved
vendor) a second ICH CAHPS survey
and submit (via a CMS-approved
vendor) the survey results to CMS.
We estimate that approximately 5,506
facilities will treat adult, in-center
hemodialysis patients in PY 2016 and,
therefore, will be eligible to receive a
score on this measure. We further
estimate that all 5,506 facilities will
report (via a CMS-approved vendor)
survey results to CMS, and that it will
take each vendor approximately 5
minutes to do so. Therefore, the
estimated total annual burden
associated with meeting the measure
requirements in PY 2016 is 459 hours
[(5/60) hours × 5,506 facilities).
According to the Bureau of Labor
Statistics, the mean hourly wage of a
registered nurse is $32.66/hour. Since
we anticipate nurses (or administrative
staff who would be paid at a lower
hourly wage) will submit this data to
CMS, we estimate that the aggregate cost
of this requirement for PY 2016 will be
$14,991 (459 hours × $32.66/hour).
We estimate that approximately 5,693
facilities will treat adult, in-center
hemodialysis patients in PY 2017 and,
therefore, will be eligible to receive a
score on this measure. We estimate that
all 5,693 facilities will administer the
ICH CAHPS survey through a thirdparty vendor and arrange for the vendor
to submit the data to CMS. We estimate
that it would take each patient 30
minutes to complete the survey (to
account for variability in education
levels) and that approximately 103
surveys per year would be taken per
facility. Interviewers from each vendor
would therefore spend a total of
approximately 52 hours per year with
patients completing these surveys (0.5
hours * 103 surveys) or $1,698 (52 hours
× $32.66) for an estimated annual
burden of $9,666,714 ($1,698 per facility
× 5,693 facilities).9 We previously
estimated that the aggregate cost of
submitting survey data to CMS is
$14,991. Therefore, we estimate that the
9 We note that this total represents an
underestimate of the overall burden because it does
not include time costs for patients.
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
total annual burden for ESRD facilities
to comply with the collection of
information requirements associated
with the proposed expanded ICH
CAHPS measure for PY 2017 and future
payment years would be approximately
$9,681,705 ($9,666,714 + $14,991)
across all ESRD facilities.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
b. Proposed Data Validation
Requirements for the PY 2016 ESRD QIP
Section III.C.13 of the proposed rule
outlines our data validation proposals.
We proposed to randomly sample
records from 300 facilities; each
sampled facility would be required to
produce up to 10 records; and the
sampled facilities will be reimbursed by
our validation contractor for the costs
associated with copying and mailing the
requested records. The burden
associated with this validation
requirement is the time and effort
necessary to submit validation data to a
CMS contractor. We estimate that it will
take each facility approximately 2.5
hours to comply with these
requirements. If 300 facilities are tasked
with providing the required
documentation, the estimated annual
burden for these facilities across all
facilities would be 750 hours (300
facilities × 2.5 hours) at a total of
$24,495 (750 hours × $32.66/hour) or
$81.65 ($24,495/300 facilities) per
facility in the sample.
2. The discussion on clarifying the
definition of routinely purchased DME
does not contain any new information
collection requirements.
3. The clarification of the the 3-year
Minimum Lifetime Requirement for
DME does not contain any new
information collection requirements.
4. The proposed implementation of
Budget-Neutral Fee Schedules for
Splints, Casts and Intraocular Lenses
does not contain any new information
collection requirements.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
at https://www.cms.gov/
PaperworkReductionActof1995/PRAL/
list.asp#TopOfPage.
If you comment on these information
collection and recordkeeping
requirements, please do either of the
following:
1. Submit your comments
electronically as specified in the
ADDRESSES section of this proposed rule;
or
2. Submit your comments to the
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: CMS Desk Officer,
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
[CMS–1526–P], Fax: (202) 395–6974; or
Email: OIRA_submission@omb.eop.gov.
IX. 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.
X. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
We examined the impacts of this
proposed rule as required by Executive
Order 12866 (September 30, 1993,
Regulatory Planning and Review) and
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011). 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 economically
significant under section 3(f)(1) of
Executive Order 12866. Accordingly,
the rule has been reviewed by the Office
of Management and Budget. We have
prepared a Regulatory Impact Analysis
that to the best of our ability presents
the costs and benefits of the proposed
rule. We solicit comments on the
regulatory impact analysis provided.
2. Statement of Need
This rule proposes a number of
routine updates for renal dialysis
services in CY 2014, proposes to
implement the fourth year of the ESRD
PPS transition, and proposes to make
several policy changes to the ESRD PPS.
These include proposed updates and
changes to the ESRD PPS base rate,
wage index values, the wage index
budget-neutrality adjustment factor, and
the outlier payment policy. This rule
will also implement section
1881(b)(14)(I), which requires the
Secretary, by comparing per patient
utilization from 2007 with such data
from 2012, to reduce the single payment
amount to reflect the Secretary’s
PO 00000
Frm 00047
Fmt 4701
Sfmt 4702
40881
estimate of the change in the utilization
of ESRD-related drugs and biologicals.
Failure to publish this proposed rule
would result in ESRD facilities not
receiving appropriate payments in CY
2014.
This rule proposes to implement the
ESRD QIP for PY 2016 and beyond by
proposing to adopt measures, scoring,
and payment reductions to incentivize
improvements in dialysis care as
directed by section 1881(h) of the Act.
Failure to propose requirements for the
PY 2016 ESRD QIP would prevent
continuation of the ESRD QIP beyond
PY 2015.
3. Overall Impact
We estimate that the proposed
revisions to the ESRD PPS will result in
a decrease of approximately $970
million in payments to ESRD facilities
in CY 2014, which includes the amount
associated with the increase in the
ESRDB market basket reduced by the
productivity adjustment, updates to
outlier threshold amounts, the inclusion
of the Pacific Rim ESRD facilities,
updates to the wage index, and the drug
utilization adjustment required by
section 1881(b)(14)(I), as added by
section 632(a) of ATRA.
For PY 2016, we estimate that the
proposed requirements related to the
ESRD QIP will cost approximately $39.5
thousand and the predicted payment
reductions will equal about $26.4
million to result in a total impact from
the proposed ESRD QIP requirements of
$26.4 million. For PY 2017 and future
payment years, we expect the costs
associated with the collection of
information requirements for the
expanded ICH CAHPS measure in the
proposed ESRD QIP to be approximately
$9.7 million.
We estimate that the proposed
changes for implementing the fee
schedule amounts from reasonable
charge payments will be budget neutral
and will have no impact to DMEPOS
providers of splints, casts and
intraocular lenses inserted in a
physician’s office.
We estimate that our proposed
clarification of the definition of
routinely purchased DME and reclassification of certain items as cap
rental items would impact certain
DMEPOS providers. We estimate that
the clarification of the 3-year minimum
lifetime requirement for DME would
have no impact on DMEPOS suppliers.
E:\FR\FM\08JYP2.SGM
08JYP2
40882
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
B. Detailed Economic Analysis
1. CY 2014 End-Stage Renal Disease
Prospective Payment System
a. Effects on ESRD Facilities
To understand the impact of the
changes affecting payments to different
categories of ESRD facilities, it is
necessary to compare estimated
payments in CY 2013 to estimated
payments in CY 2014. To estimate the
impact among various types of ESRD
facilities, it is imperative that the
estimates of payments in CY 2013 and
CY 2014 contain similar inputs.
Therefore, we simulated payments only
for those ESRD facilities for which we
are able to calculate both current
payments and new payments.
For this proposed rule, we used the
December 2012 update of CY 2012
National Claims History file as a basis
for Medicare dialysis treatments and
payments under the ESRD PPS. We
updated the 2012 claims to 2013 and
2014 using various updates. The
updates to the ESRD PPS base rate are
described in section II.B of this
proposed rule. Table 12 shows the
impact of the estimated CY 2014 ESRD
payments compared to estimated
payments to ESRD facilities in CY 2013.
TABLE 12—IMPACT OF PROPOSED CHANGES IN PAYMENTS TO ESRD FACILITIES FOR CY 2014 PROPOSED RULE
All Facilities ..............................
Type:
Freestanding .....................
Hospital based ..................
Ownership Type:
Large dialysis organization
Regional chain ..................
Independent ......................
Hospital based 1 ................
Unknown ...........................
Geographic Location:
Rural .................................
Urban ................................
Census Region:
East North Central ............
East South Central ...........
Middle Atlantic ..................
Mountain ...........................
New England ....................
Pacific 2 .............................
Puerto Rico and Virgin Islands ..............................
South Atlantic ....................
West North Central ...........
West South Central ..........
Facility Size:
Less than 4,000 treatments 3 ..........................
4,000 to 9,999 treatments
10,000 or more treatments
Unknown ...........................
Percentage of Pediatric Patients:
Less than 2% ....................
Between 2% and 19% ......
Between 20% and 49% ....
More than 50% .................
Number of
facilities
Effect of 2014
changes in
outlier policy 4
(percent)
Effect of 2014
changes in
wage indexes
(percent)
A
Facility type
Number of
treatments
(in millions)
Effect of 2014
changes in
market
basket
minus
productivity
update
(percent)
B
C
D
E
Effect of 2014
changes in
base rate due
to drug
utilization
(percent)
Effect of
total 2014
changes 5
(percent)
F
G
5,771
38.1
0.4
0.0
2.5
¥12.0
¥9.4
5,270
501
35.4
2.7
0.4
0.3
0.0
0.1
2.5
2.5
¥12.0
¥11.9
¥9.4
¥9.3
3,769
885
614
400
103
25.9
6.1
3.9
2.1
0.2
0.4
0.4
0.2
0.2
0.3
0.0
0.0
0.1
0.1
¥0.2
2.5
2.5
2.5
2.5
2.5
¥12.0
¥12.0
¥12.0
¥11.9
¥12.0
¥9.4
¥9.4
¥9.5
¥9.4
¥9.6
1,257
4,514
6.3
31.8
0.4
0.4
¥0.1
0.0
2.5
2.5
¥12.0
¥12.0
¥9.5
¥9.4
946
477
634
340
170
684
5.7
2.9
4.6
1.8
1.3
5.3
0.4
0.5
0.4
0.3
0.4
0.1
¥0.2
¥0.2
0.5
0.1
0.2
0.4
2.5
2.5
2.5
2.5
2.5
2.5
¥11.9
¥11.9
¥12.0
¥12.0
¥12.0
¥12.0
¥9.5
¥9.5
¥9.0
¥9.4
¥9.2
¥9.3
41
1,288
416
775
0.3
8.8
2.0
5.5
0.4
0.5
0.4
0.5
¥2.3
¥0.3
¥0.1
¥0.1
2.5
2.5
2.5
2.5
¥11.9
¥12.0
¥12.0
¥11.9
¥11.5
¥9.6
¥9.5
¥9.5
1,044
2,157
2,400
170
2.6
10.4
24.7
0.4
0.4
0.4
0.4
0.4
0.0
¥0.1
0.0
¥0.1
2.5
2.5
2.5
2.5
¥12.0
¥12.0
¥12.0
¥12.0
¥9.4
¥9.5
¥9.4
¥9.5
5,662
44
6
59
37.7
0.3
0.0
0.1
0.4
0.3
0.1
0.0
0.0
0.0
¥0.3
0.1
2.5
2.5
2.5
2.5
¥12.0
¥11.9
¥12.0
¥12.0
¥9.4
¥9.5
¥9.9
¥9.7
1 Includes
hospital-based ESRD facilities not reported to have large dialysis organization or regional chain ownership.
ESRD facilities located in Guam, American Samoa, and the Northern Mariana Islands.
the 1,044 ESRD facilities with less than 4,000 treatments, only 375 qualify for the low-volume adjustment. The low-volume adjustment is
mandated by Congress, and is not applied to pediatric patients. The impact to these low-volume facilities is a 9.5 percent decrease in payments.
4 Includes the effect of including the Pacific Rim ESRD facilities of Guam, American Samoa, and the Northern Mariana Islands into the PPS.
5 Includes the effect of Market Basket minus productivity increase of 2.5 percent to the ESRD PPS base rate and the effect of the $29.52 decrease in the base rate due to the drop in drug utilization.
Note:Totals do not necessarily equal the sum of rounded parts, as percentages are multiplicative, not additive.
2 Includes
tkelley on DSK3SPTVN1PROD with PROPOSALS2
3 Of
Column A of the impact table
indicates the number of ESRD facilities
for each impact category and column B
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
indicates the number of dialysis
treatments (in millions). The overall
effect of the proposed changes to the
PO 00000
Frm 00048
Fmt 4701
Sfmt 4702
outlier payment policy described in
section II.B.6. of this proposed rule is
shown in column C. For CY 2014, the
E:\FR\FM\08JYP2.SGM
08JYP2
40883
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
impact on all facilities as a result of the
changes to the outlier payment policy
would be a 0.4 percent increase in
estimated payments. The estimated
impact of the changes to outlier
payment policy ranges from a 0.0
percent to a 0.5 percent increase. Nearly
all ESRD facilities are anticipated to
experience a positive effect in their
estimated CY 2014 payments as a result
of the proposed outlier policy changes.
Column D shows the effect of the
wage index on ESRD facilities and
reflects the CY 2014 wage index values
for the ESRD PPS payments. Facilities
located in the census region of Puerto
Rico and the Virgin Islands would
receive a 2.3 percent decrease in
estimated payments in CY 2014. Since
most of the facilities in this category are
located in Puerto Rico, the decrease is
primarily due to the reduction in the
wage index floor, (which only affects
facilities in Puerto Rico in CY 2014).
The other categories of types of facilities
in the impact table show changes in
estimated payments ranging from a 0.3
percent decrease to a 0.5 percent
increase due to the update of the wage
index.
Column E shows the effect of the
ESRDB market basket increase minus
productivity adjustment. The impact on
all facilities would be a 2.5 percent
increase.
Column F shows the effect of the drug
utilization adjustment required by
section 1881(b)(14)(I). For CY 2014, the
impact on all facilities as a result of the
$29.52 decrease to the base rate, as
described in section II.B.2.a., would be
a 12 percent decrease in estimated
payments. The estimated impact ranges
from 11.9 percent to 12 percent
decrease.
Column G reflects the overall impact
(that is, the effects of the proposed
outlier policy changes, the proposed
wage index, the effect of the ESRDB
market basket increase minus
productivity adjustment, and the effect
of the drug utilization adjustment
required by section 1881(b)(14)(I). We
expect that overall, ESRD facilities will
experience a 9.4 percent decrease in
estimated payments in 2014. ESRD
facilities in Puerto Rico and the Virgin
Islands are expected to receive an 11.5
percent decrease in their estimated
payments in CY 2014. This larger
decrease is primarily due to the negative
impact of the wage index. The other
categories of types of facilities in the
impact table show negative impacts
ranging from a decrease of 9.9 percent
to 9.0 percent in their 2014 estimated
payments.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
b. Effects on Other Providers
Under the ESRD PPS, ESRD facilities
are paid directly for the renal dialysis
bundle and other provider types such as
laboratories, DME suppliers, and
pharmacies, may no longer bill
Medicare directly for renal dialysis
services. Rather, effective January 1,
2011, such other providers can only
furnish renal dialysis services under
arrangements with ESRD facilities and
must seek payment from ESRD facilities
rather than Medicare. Under the ESRD
PPS, Medicare pays ESRD facilities one
payment for renal dialysis services,
which may have been separately paid to
suppliers by Medicare prior to the
implementation of the ESRD PPS.
Therefore, in CY 2014, the fourth year
of the ESRD PPS, we estimate that the
proposed ESRD PPS will have zero
impact on these other providers.
c. Effects on the Medicare Program
We estimate that Medicare spending
(total Medicare program payments) for
ESRD facilities in CY 2014 will be
approximately $8 billion. This estimate
takes into account a projected increase
in fee-for-service Medicare dialysis
beneficiary enrollment of 3.8 percent in
CY 2014.
d. Effects on Medicare Beneficiaries
Under the ESRD PPS, beneficiaries are
responsible for paying 20 percent of the
ESRD PPS payment amount. As a result
of the projected 9.4 percent overall
decrease in the proposed ESRD PPS
payment amounts in CY 2014, we
estimate that there will be a decrease in
beneficiary co-insurance payments of
9.4 percent in CY 2014, which translates
to approximately $190 million.
2. End-Stage Renal Disease Quality
Incentive Program
a. Effects of the PY 2016 ESRD QIP
The ESRD QIP provisions are
intended to prevent possible reductions
in the quality of ESRD dialysis facility
services provided to beneficiaries as a
result of payment changes under the
ESRD PPS by implementing a ESRD QIP
that reduces ESRD PPS payments by up
to 2 percent for dialysis facilities that
fail to meet or exceed a TPS with
respect to performance standards
established by the Secretary with
respect to certain specified measures.
The methodology that we are proposing
to determine a facility’s TPS is
described in section III.C.11 of this
proposed rule. Any reductions in ESRD
PPS payments as a result of a facility’s
performance under the PY 2016 ESRD
QIP would begin with services
furnished on January 1, 2016.
As a result, based on the ESRD QIP
outlined in this proposed rule, we
estimate that, of the total number of
dialysis facilities (including those not
receiving an ESRD QIP TPS),
approximately 36 percent or 2,069 of the
facilities would likely receive a payment
reduction in PY 2016. Facilities that do
not receive a TPS are not eligible for a
payment reduction.
The ESRD QIP impact assessment
assumes an initial count of 5,771
dialysis facilities paid through the PPS.
Table 13 shows the overall estimated
distribution of payment reductions
resulting from the PY 2016 ESRD QIP.
TABLE 13—ESTIMATED DISTRIBUTION
OF PY 2016 ESRD QIP PAYMENT
REDUCTIONS
Payment
reduction
percent
Number of
facilities
Percent of
facilities
e. Alternatives Considered
For this proposed rule, we proposed
to implement the full reduction required
by section 1881(b)(14)(I) in CY 2014. In
particular, we proposed a one-time
reduction of $29.52 to the ESRD PPS
base rate. We considered proposing to
implement the reduction using a
transition. For example, we considered
transitioning the reduction over a 2 or
3-year period. We chose to implement
the full reduction by reducing the ESRD
PPS base rate by an adjustment to reflect
change in the utilization of ESRDrelated drugs and biologicals by
comparing utilization data from 2007
with such data from 2012.
PO 00000
Frm 00049
Fmt 4701
Sfmt 4702
0.0
0.5
1.0
1.5
2.0
.....................
.....................
.....................
.....................
.....................
3,417
994
583
280
212
62.3
18.1
10.6
5.1
3.9
Note:This table excludes 285 facilities that
did not receive a score because they did not
have enough data to receive a Total Performance Score.
To estimate whether or not a facility
would receive a payment reduction
under the proposed approach, we
scored each facility on achievement and
improvement on several measures we
have previously finalized and for which
there were available data from
CROWNWeb and Medicare claims.
Measures used for the simulation are
shown in Table 14.
E:\FR\FM\08JYP2.SGM
08JYP2
40884
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
TABLE 14—DATA USED TO ESTIMATE PY 2016 ESRD QIP PAYMENT REDUCTIONS
Period of time used to calculate achievement thresholds,
performance standards, benchmarks, and improvement
thresholds
Measure
Hemoglobin Greater Than 12 g/dL ........................................
Vascular Access Type:
% Fistula .........................................................................
% Catheter ......................................................................
Kt/V:
Adult HD .........................................................................
Adult PD .........................................................................
Pediatric HD ...................................................................
Hypercalcemia .......................................................................
Clinical measures with less than 11
cases for a facility were not included in
that facility’s Total Performance Score.
Each facility’s Total Performance Score
was compared to the estimated
minimum Total Performance Score and
the payment reduction table found in
section III.C.11 of this proposed rule.
Facilities were required to have a score
on at least one clinical measure to
receive a Total Performance Score. For
these simulations, the NHSN
Bloodstream Infection in Hemodialysis
Outpatients and Patient Informed
Consent for Anemia Treatment clinical
measures, as well as the reporting
measures were not included due to lack
of data availability. Therefore, the
simulated facility Total Performance
Scores were calculated using only some
of the clinical measure scores.
To estimate the total payment
reductions in PY 2016 for each facility
Performance period
Jan 2012–Jun 2012 ..............................................................
July 2012–Dec 2012.
Jan 2011–Dec 2011 ..............................................................
Jan 2011–Dec 2011 ..............................................................
Jan 2012–Dec 2012.
Jan 2012–Dec 2012.
Jan
Jan
Jan
Jan
Jan 2012–Dec 2012.
Jan 2012–Dec 2012.
Jan 2012–Dec 2012.
May 2012–Dec
2012.
2011–Dec
2011–Dec
2011–Dec
2011–Dec
2011
2011
2011
2011
..............................................................
..............................................................
..............................................................
..............................................................
resulting from this proposed rule, we
multiplied the total Medicare payments
to the facility during the one year period
between January 2012 and December
2012 by the facility’s estimated payment
reduction percentage expected under
the ESRD QIP, yielding a total payment
reduction amount for each facility:
(Total ESRD payment in January 2012
through December 2012 times the
estimated payment reduction
percentage). For PY 2016 the total
payment reduction for all of the 2,069
facilities expected to receive a reduction
is approximately $26.4 million
($26,355,878). Further, we estimate that
the total costs associated with the
collection of information requirements
for PY 2016 described in section VII.B.2
of this proposed rule would be
approximately $15 thousand for all
ESRD facilities. As a result, we estimate
that ESRD facilities will experience an
aggregate impact of $26.4 million
($39,486 + $26,355,878= $26,395,364) in
PY 2016, as a result of the PY 2016
ESRD QIP.
Table 15 below shows the estimated
impact of the finalized ESRD QIP
payment reductions to all ESRD
facilities for PY 2016. The table details
the distribution of ESRD facilities by
facility size (both among facilities
considered to be small entities and by
number of treatments per facility),
geography (both urban/rural and by
region), and by facility type (hospital
based/freestanding facilities). Given that
the time periods used for these
calculations will differ from those we
propose to use for the PY 2016 ESRD
QIP, the actual impact of the PY 2016
ESRD QIP may vary significantly from
the values provided here.
TABLE 15—IMPACT OF PROPOSED QIP PAYMENT REDUCTIONS TO ESRD FACILITIES FOR PY 2016Q
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Number of
facilities
All Facilities ..........................................................................
Facility Type:
Freestanding .................................................................
Hospital-based ..............................................................
Ownership Type:
Large Dialysis ...............................................................
Regional Chain .............................................................
Independent ..................................................................
Hospital-based (non-chain) ...........................................
Unknown .......................................................................
Facility Size:
Large Entities ................................................................
Small Entities 1 ..............................................................
Unknown .......................................................................
Urban/Rural Status:
Rural .............................................................................
Urban ............................................................................
Census Region:
Northeast ......................................................................
Midwest .........................................................................
South .............................................................................
West ..............................................................................
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00050
Number of
Medicare
treatments
2012
(in millions) 3
Number of
facilities with
QIP score
Number of
facilities
expected to
receive a
payment
reduction
Payment
reduction
(percent
change
in total ESRD
payments)
5,771
38.1
5,486
2,069
¥0.35
5,270
501
35.4
2.7
5,116
370
1,854
215
¥0.32
¥0.67
3,769
885
614
400
103
25.9
6.1
3.9
2.1
0.2
3,710
849
572
289
66
1,228
355
292
169
25
¥0.29
¥0.36
¥0.52
¥0.66
¥0.47
4,654
1,014
103
32.0
5.9
0.2
4,559
861
66
1,583
461
25
¥0.30
¥0.57
¥0.47
1,257
4,514
6.3
31.8
1,191
4,295
416
1,653
¥0.31
¥0.35
786
1,325
2,501
998
5.8
7.7
17.1
7.0
741
1,233
2,440
966
309
478
923
302
¥0.40
¥0.37
¥0.34
¥0.27
Fmt 4701
Sfmt 4702
E:\FR\FM\08JYP2.SGM
08JYP2
40885
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
TABLE 15—IMPACT OF PROPOSED QIP PAYMENT REDUCTIONS TO ESRD FACILITIES FOR PY 2016Q—Continued
Number of
facilities
US Territories 2 .............................................................
Census Division:
Pacific Rim ....................................................................
East North Central ........................................................
East South Central .......................................................
Middle Atlantic ..............................................................
Mountain .......................................................................
New England ................................................................
Pacific ...........................................................................
South Atlantic ................................................................
West North Central .......................................................
West South Central ......................................................
US Territories 2 .............................................................
Facility Size (# of total treatments):
Less than 4,000 treatments ..........................................
4,000–9,999 treatments ................................................
Over 10,000 treatments ................................................
Unknown .......................................................................
Number of
Medicare
treatments
2012
(in millions) 3
Number of
facilities with
QIP score
Number of
facilities
expected to
receive a
payment
reduction
Payment
reduction
(percent
change
in total ESRD
payments)
161
0.5
106
57
¥0.66
7
946
477
634
340
170
677
1,288
416
775
41
0.1
5.7
2.9
4.6
1.8
1.3
5.2
8.8
2.0
5.5
0.3
7
868
465
595
325
154
652
1,245
383
754
38
5
354
147
254
82
58
224
490
129
298
28
¥0.92
¥0.38
¥0.27
¥0.42
¥0.21
¥0.28
¥0.30
¥0.37
¥0.34
¥0.34
¥0.86
1,044
2,157
2,400
170
2.6
10.4
24.7
0.4
853
2,136
2,384
113
273
730
1,027
39
¥0.36
¥0.30
¥0.38
¥0.41
1 Small
Entities include hospital-based and satellite facilities and non-chain facilities based on DFC self-reported status.
Puerto Rico and Virgin Islands.
3 Based on claims data through December 2012.
2 Includes
tkelley on DSK3SPTVN1PROD with PROPOSALS2
b. Alternatives Considered for the PY
2016 ESRD QIP
In the proposed PY 2016 ESRD QIP,
we selected measures that we believe
are important indicators of patient
outcomes and quality of care as
discussed in section III.C of this
proposed rule. Poor management of
anemia, for example, can lead to
avoidable hospitalizations, decreased
quality of life, and death. In order to
provide strong incentives to improve
patient outcomes in this clinically
important area, we considered
proposing a clinical measure for
Pediatric Iron Therapy. However, upon
further review we recognized that we
lacked the necessary baseline data to
establish achievement thresholds,
performance standards, and
benchmarks. We, therefore, proposed a
reporting measure in order to gather the
data we will need to introduce a clinical
measure in the future. In the case of the
NHSN Bloodstream Event in
Hemodialysis Outpatient measure, we
considered proposing a reporting
measure instead of a clinical measure,
because we lacked the necessary
baseline data to establish achievement
thresholds, performance standards, and
benchmarks. However, we decided not
to do so. Due to the great impact
hospital acquired infections have upon
patients and the industry, we believe it
is important to begin assessing facilities
on the number of these events rather
than on merely whether they report
these events as soon as possible.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
Similarly, in the case of the Patient
Informed Consent for Anemia Treatment
measure, we considered proposing a
reporting measure instead of a clinical
measure, because we lacked the
necessary baseline data to establish
achievement thresholds, performance
standards, and benchmarks. We decided
not to do because we believe that
providing counseling on the risks and
benefits of anemia treatment, and
seeking informed consent for such
treatment, is already a standard of
clinical care in the ESRD provider
community. We also considered
proposing the Standardized
Hospitalization Ratio Admissions (SHR)
measure and the Standardized Mortality
Ratio (SMR) measure as reporting
measures for the PY 2016 ESRD QIP. We
decided not to do so due to outstanding
concerns about the measures’ validity
and reliability. As an alternative, we
proposed the Comorbidity reporting
measure to provide a reliable source of
data that we can use to properly riskadjust SHR and SMR clinical measures
(should we propose to adopt such
measures in the future), and to improve
our understanding of the risk factors
that contribute to morbidity and
mortality in the ESRD patient
population.
In developing the proposed scoring
methodology for the PY 2016 ESRD QIP,
we considered several alternatives. For
example, we considered weighting the
clinical measures at 80 percent and the
reporting measures at 20 percent of the
PO 00000
Frm 00051
Fmt 4701
Sfmt 4702
Total Performance Score. We ultimately
decided to propose the weighting
methodology used in the PY 2015 ESRD
QIP because the ratio of clinical to
reporting measures did not change
significantly, and also because we
wanted to retain a strong incentive for
facilities to meet the requirements for
the reporting measures. We also
considered a number of ways to
establish achievement thresholds and
benchmarks for the NHSN clinical
measure. For example, we considered
using baseline data from CYs 2012
through 2013 to set achievement
thresholds and benchmarks. However,
we ultimately decided to propose to use
data from CY 2014 when establishing
baseline data for scoring purposes,
because facilities were not required to
submit twelve full months of NHSN
data during CY 2012–2013, and rates of
healthcare-acquired infections are
susceptible to seasonal variability. In
light of the importance of monitoring
and preventing infections in the ESRD
population, we decided that it would be
preferable to propose a clinical measure
with equivalent baseline and
performance periods, rather than a
reporting measure that would have less
of a direct impact on clinical practice.
We also considered a number of ways to
score the Patient Informed Consent for
Anemia Treatment clinical measure. In
this case, we lacked baseline data that
could be used to establish achievement
thresholds and benchmarks, so we
considered proposing a reporting
E:\FR\FM\08JYP2.SGM
08JYP2
40886
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
measure in place of the clinical
measure. In light of the importance of
the measure, however, we ultimately
decided to propose a clinical measure in
order to provide a stronger incentive for
facilities to obtain informed consent
from patients receiving anemia
treatment. In considering possible
scoring methodologies for the measure,
we specifically considered setting the
achievement threshold at 100 percent
because we believe that facilities should
always obtain informed consent from
patients receiving ESA. However, we
recognized that unexpected events in
the clinical setting might preclude the
possibility of obtaining informed
consent in every instance, so we
ultimately decided to propose to set the
achievement threshold for the measure
at 92 percent. We selected 92 percent
because this would allow facilities with
26 patients to meet the achievement
threshold if they failed to obtain
informed consent from 2 patients (see
section III.C.8 for more details).
3. DMEPOS Provisions
a. Effects of the Implementation of Fee
Schedules for Splints, Casts and IOLs
The implementation of fee schedules
for use in paying claims for splints,
casts, and IOLs inserted in a physician’s
office would result in administrative
savings associated with determining and
implementing the Medicare allowed
payment amounts for these items. As a
result, the agency would save
approximately $94,000 in annual
administrative expenses for calculating
reasonable charge payment amounts and
maintaining multiple pricing files
necessary for making payment on a
reasonable charge basis.
b. Clarification of the 3-Year MLR for
DME
We expect no significant impact
regarding application of the 3-year MLR
for DME. As we noted in the final
regulation for the 3-year MLR, we
believe that a vast majority of the
categories of items that were classified
as DME before January 1, 2012, did
function for 3 or more years (76 FR
70289). The 3-year MLR is designed to
represent a minimum threshold for
determination of durability for
equipment that is consistent with the
statutory DME payment provisions and
applies on a prospective basis, effective
January 1, 2012. CMS recognizes that
the healthcare industry and
beneficiaries have come to rely on items
that have qualified as DME prior to
January 1, 2012, regardless of whether
those items met the 3-year MLR set forth
at § 414.202. We note that given that
reliance and consistent with the
regulation at § 414.202, CMS will not
reopen those prior decisions and
reclassify the equipment in light of the
new 3-year standard. We believe that
continuing the Medicare coverage for all
the items that qualified as DME on or
prior to January 1, 2012, would avoid
disrupting the continuity of care for the
beneficiaries that received these items
for medical treatment prior to January 1,
2012. As noted in the final rule (76 FR
70301, 70311) it is difficult to predict
how many different types of new
devices will be introduced in the market
in the future that may or may not meet
the 3-year MLR. However, even absent
the 3-year MLR, it is likely that new
products which do not meet the 3-year
MLR will not qualify as DME based
upon our current interpretation of the
criteria for DME. It is possible that with
the clarification of the 3-year MLR, we
will limit what can be covered as DME
compared to what we would have
covered as DME absent this regulatory
clarification. Additionally, to the extent
the regulatory change is binding to some
new products, there may be reduced
program cost. The final rule does apply
to items that were classified as DME on
or before January 1, 2012 which tends
to lessen the overall impact to the
program. In general, we expect that the
final rule (76 FR 70311) and
clarification we are now proposing of
the 3-year MLR would have a minimal,
if any, savings impact on the
expenditures under program. This is
because the vast majority if items
classified as DME in the past have had
lifetimes of 3 years or more and so there
would be very few instances, if any,
where this clarification will have any
impact on classification of items as
DME.
c. Definition of Routinely Purchased
DME
As discussed in section IV of this rule,
this rule would clarify the definition of
routinely purchased equipment set forth
at section § 414.220(a) and would
classify an expensive item of DME or
accessory (over $150) as a capped rental
item if it was not acquired by purchase
on a national basis at least 75 percent of
the time during the period July 1986
through June 1987. Because concerns
were brought to our attention on the
application of the definition of routinely
purchased DME, we performed a review
of the approximately 250 HCPCS codes
assigned to the routinely purchased
category of DME in excess of $150.
Based on our review, and given the
definition of routinely purchased
equipment set forth at section § 414.220,
we would classify such items in the
capped rental category if the items were
not acquired by purchase on a national
basis at least 75 percent of the time
during the period July 1986 through
June 1987.
As shown in Table 11 of section IV of
the preamble, our review identified 80
current HCPCS codes requiring
reclassification from routinely
purchased DME to capped rental DME.
The majority of codes relate to manual
wheelchairs and wheelchair accessories.
We have displayed in Column B
accessories of complex rehabilitative
power wheelchairs that would be
classified as capped rental items and for
which suppliers must also offer to the
beneficiary on a lump sum purchase
basis in accordance with § 414.229(h)(3)
of the regulations. In addition, we have
displayed in Table 16 below and
Column B of Table 11 of section IV of
the preamble approximately 14 codes
which would be reclassified in two
stages effective July 1, 2016, rather than
January 1, 2014, for all items included
in competitive bidding programs other
than those furnished in the Round 1
Recompete programs and areas; and on
January 1, 2017, for those items
furnished as part of the Round I
Recompete competitive bidding
programs.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
TABLE 16—ITEMS RECLASSIFIED TO CAPPED RENTAL DME CATEGORY EFFECTIVE JULY 1, 2016 *
HCPCS category
HCPCS
Support Surfaces .........................................................
Walkers ........................................................................
Wheelchairs Options/Accessories ...............................
Wheelchair Seating ......................................................
E0197
E0140 E0149
E0985 E1020 E1028 E2228 E2368 E2369 E2370 E2375 K0015 K0070
E0955
* Items furnished in accordance with Round 1 Recompete contracts would be reclassified effective January 1, 2017.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00052
Fmt 4701
Sfmt 4702
E:\FR\FM\08JYP2.SGM
08JYP2
40887
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
eliminate the lump sum purchase
method for the certain items, and
instead payment would be made under
the monthly rental method resulting in
lower aggregate payments because many
beneficiaries do not rent items for as
TABLE 17—IMPACT OF ITEMS RECLAS- long as 13 months. In order to prepare
SIFIED TO CAPPED RENTAL DME our impact on the Medicare program,
we reviewed claims data and utilization
CATEGORY
for all items currently classified as
capped rental items from 2009 through
Impact to the federal
FY
government
2011 and determined that the weighted
(in $ millions)
average number of allowed monthly
rental services for beneficiaries
2014 ......................
¥20
2015 ......................
¥20 receiving capped rental items during
2016 ......................
¥20 that period was 8 months. We therefore
2017 ......................
¥30 used 8 months as the estimated number
2018 ......................
¥40 of months beneficiaries would rent
items in Table 11 of section IV of the
The decrease in expenditures is
preamble that would not have a
expected because the changes would
purchase option. All anticipated savings
In Table 17 below, we show estimated
savings associated with making
payment on a capped rental basis rather
than a lump sum purchase basis for
items that would be reclassified.
include the price growth for the covered
item fee schedule update factors for
DME mandated by section 1834(a)(14) of
the Act. In addition, our estimate takes
into account projected changes in DME
beneficiary enrollment. Furthermore, we
reflected the savings for these items that
are currently included under any
existing competitive bidding program
and which will be reclassified from
routinely purchased to capped rental
effective July 1, 2016.
From table 11 of section IV of the
preamble above, entitled Routinely
Purchased Items Reclassified to Capped
Rental, for items that would be paid on
a capped rental basis with no purchase
option, the highest volume items in
terms of 2012 allowed charges are:
TABLE 18—THREE HIGHEST VOLUME ROUTINELY PURCHASED ITEMS RECLASSIFIED TO CAPPED RENTAL
HCPCS
Item
E0760 ......................
E2510 ......................
E1161 ......................
Ultrasonic Bone Growth Stimulator .......................................................
Speech Generating Device ....................................................................
Tilt In Space Manual Wheelchair ..........................................................
The allowed charges in 2012 for these
three items combined were
approximately $60 million, which
makes up almost half of approximately
$130 million in allowed charges for
items that would no longer be eligible
for purchase. Under the capped rental
payment rules, these items would be
Purchase fee
rented for up to 13-continuous months,
following which title to the equipment
would transfer from the supplier to the
beneficiary.
C. Accounting Statement
As required by OMB Circular A–4
(available at https://
$3,514
7,356
2,571
Allowed
charges
Code added
$21,370,310
20,170,162
18,666,674
1997
2001
2003
www.whitehouse.gov/omb/
circulars_a004_a-4), in Table 19 below,
we have prepared an accounting
statement showing the classification of
the transfers and costs associated with
the various provisions of this proposed
rule.
TABLE 19—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED TRANSFERS AND COSTS/SAVINGS
Category
Transfers
ESRD PPS for CY 2014
Annualized Monetized Transfers. ....................................................................................
From Whom to Whom .....................................................................................................
Increased Beneficiary Co-insurance Payments ...............................................................
From Whom to Whom .....................................................................................................
$¥780 million.
Federal government to ESRD providers.
$¥190 million.
Beneficiaries to ESRD providers.
ESRD QIP for PY 2016
Annualized Monetized Transfers .....................................................................................
From Whom to Whom .....................................................................................................
¥$26.4 million *
Federal government to ESRD providers.
Category
Costs
Annualized Monetized ESRD Provider Costs .................................................................
$39.5 thousand **
tkelley on DSK3SPTVN1PROD with PROPOSALS2
DME Definition of Routinely Purchased DME
Category
Transfers
Annualized Monetized Transfer Payments .................................
¥$25.3 million .......
¥$25.7 million .......
From Whom to Whom .................................................................
Federal government to Medicare providers.
2013
2013
7%
3%
2014–2018
2014–2018
* It is the reduced payment to the ESRD facilities, which fall below the quality standards as stated in section III.C.11 of this proposed rule.
** It is the cost associated with the collection of information requirements for all ESRD facilities.
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PO 00000
Frm 00053
Fmt 4701
Sfmt 4702
E:\FR\FM\08JYP2.SGM
08JYP2
40888
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
XI. Regulatory Flexibility Act Analysis
The Regulatory Flexibility Act
(September 19, 1980, Pub. L. 96–354)
(RFA) requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions.
Approximately 18 percent of ESRD
dialysis facilities are considered small
entities according to the Small Business
Administration’s (SBA) size standards,
which classifies small businesses as
those dialysis facilities having total
revenues of less than $35.5 million in
any 1 year. Individuals and States are
not included in the definitions of a
small entity. For more information on
SBA’s size standards, see the Small
Business Administration’s Web site at
https://www.sba.gov/content/smallbusiness-size-standards (Kidney
Dialysis Centers are listed as 621492
with a size standard of $35.5 million).
We do not believe ESRD facilities are
operated by small government entities
such as counties or towns with
populations of 50,000 or less, and
therefore, they are not enumerated or
included in this estimated RFA analysis.
Individuals and States are not included
in the definition of a small entity.
For purposes of the RFA, we estimate
that approximately 18 percent of ESRD
facilities are small entities as that term
is used in the RFA (which includes
small businesses, nonprofit
organizations, and small governmental
jurisdictions). This amount is based on
the number of ESRD facilities shown in
the ownership category in Table 12.
Using the definitions in this ownership
category, we consider the 614 facilities
that are independent and the 400
facilities that are shown as hospitalbased to be small entities. The ESRD
facilities that are owned and operated
by LDOs and regional chains would
have total revenues of more than $35.5
million in any year when the total
revenues for all locations are combined
for each business (individual LDO or
regional chain), and are not, therefore,
included as small entities.
For the ESRD PPS updates proposed
in this rule, a hospital-based ESRD
facility (as defined by ownership type)
is estimated to receive a 9.4 percent
decrease in payments for CY 2014. An
independent facility (as defined by
ownership type) is estimated to receive
a 9.5 percent decrease in payments for
CY 2014.
Based on the proposed QIP payment
reduction impacts to ESRD facilities for
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
PY 2016, we estimate that of the 2,069
ESRD facilities expected to receive a
payment reduction, 461 ESRD small
entity facilities would experience a
payment reduction (ranging from 0.5
percent up to 2.0 of total payments), as
presented in Table 13 (‘‘Estimated
Distribution of PY 2016 ESRD QIP
Payment Reductions’’) and Table 15
(‘‘Impact of Proposed QIP Payment
Reductions to ESRD Facilities for PY
2016’’) above. We anticipate the
payment reductions to average
approximately $12,738 per facility
among the 2,069 facilities receiving a
payment reduction, with an average of
$13,810 per small entity facilities
receiving a payment reduction. Using
our projections of facility performance,
we then estimated the impact of
anticipated payment reductions on
ESRD small entities, by comparing the
total payment reductions for the 461
small entities expected to receive a
payment reduction, with the aggregate
ESRD payments to all small entities. We
estimate that there are a total of 1,014
small entity facilities. For this entire
group of 1,014 ESRD small entity
facilities, a decrease of 0.57 percent in
aggregate ESRD payments is observed.
Splints, casts and intraocular lenses
(IOLs) affected by this rule are generally
furnished by physicians. Approximately
95 percent of physicians are considered
to be small entities for the purposes of
the RFA. Individuals and states are not
included in the definition of a small
entity. The reasonable charge payment
amounts for splints and casts are based
on national reasonable charge amounts
increased each year by the 12-month
percentage change in the CPI–U ending
June of the previous year. These
national inflation-indexed charges can
easily be converted to fee schedule
amounts with no impact on the national
Medicare payment amounts for these
items. Therefore, the fee schedule
amounts that would take effect on
January 1, 2014, for splints and casts
would be the same as the reasonable
charge amounts that would take effect
on January 1, 2014, for these items. This
rule would have no impact on small
businesses that furnish these items.
Given that Medicare pays for very few
intraocular lenses inserted in a
physician’s office, these entities do not
rely on Medicare payment for these
items to support their businesses.
Because the fee schedule amounts that
would take effect on January 1, 2014, for
intraocular lenses inserted in a
physician’s office would be based on the
national average allowed charge for the
item, the payment amounts these
entities would receive under the fee
PO 00000
Frm 00054
Fmt 4701
Sfmt 4702
schedule will be, on average, the same
amounts they are currently paid for
these items when considering the small
national volume of claims as a whole.
For example, in 2011, the average
allowed charge for an IOL inserted in a
physician’s office was $174 for just 287
cases nationwide. If a particular
physician office is a small business that
charges less than $174 per IOL, a
national fee schedule amount of $174
could increase payment for this small
business for this item. Alternatively, if
a particular physician office is a small
business that charges more than $174
per IOL, a national fee schedule amount
of $174 could decrease payment for this
small business for this item. However,
with only 287 cases nationwide,
implementing a national fee of $174
would not have a significant impact on
any physician office that is a small
business because the volume of claims
indicates that the small businesses are
not relying on payment for these items
to fund their businesses (physician
practices) as a whole. Therefore, we
expect that the overall impact of this
rule on small businesses that are
physician offices that insert IOLs
covered by Medicare would be minimal.
Approximately 85 percent of suppliers
of DMEPOS in general are considered to
be small entities for the purposes of the
RFA. We expect that the impact of
moving certain expensive DME items
from the routinely purchased payment
class to the capped rental payment class
on small business will be minimal since
the suppliers would still receive 105
percent of the purchase fee for items
that are rented for the full 13-month
capped rental period. In addition, the
supplier would retain ownership of
equipment that is not used for 13
months and can furnish the equipment
to another beneficiary, beginning a new,
separate 13-month capped rental period
for the same item.
Therefore, the Secretary has
determined that this proposed rule will
have a significant economic impact on
a substantial number of small entities.
We solicit comment on the RFA analysis
provided.
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. Any such regulatory impact
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 a metropolitan
statistical area and has fewer than 100
beds. We do not believe this proposed
rule will have a significant impact on
E:\FR\FM\08JYP2.SGM
08JYP2
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
40889
operations of a substantial number of
small rural hospitals because most
dialysis facilities are freestanding.
While there are 159 rural hospital-based
dialysis facilities, we do not know how
many of them are based at hospitals
with fewer than 100 beds. However,
overall, the 159 rural hospital-based
dialysis facilities will experience an
estimated 10.1 percent decrease in
payments. As a result, this proposed
rule is estimated to have a significant
impact on small rural hospitals.
Therefore, the Secretary has determined
that this proposed rule will have a
significant impact on the operations of
a substantial number of small rural
hospitals.
XV. Files Available to the Public via the
Internet
XII. Unfunded Mandates Reform Act
Analysis
List of Subjects
6. Section 414.100 is revised to read
as follows:
42 CFR Part 413
§ 414.100
Health facilities, Kidney diseases,
Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 414
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medicare,
and 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 follows:
This subpart implements fee
schedules for PEN items and services,
splints and casts, and IOLs inserted in
a physician’s office as authorized by
section 1842(s) of the Act.
■ 7. Section 414.102 is amended by
revising paragraphs (a) introductory
text, (a)(2), (b)(1), and (c) to read as
follows:
§ 414.102
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Pub. L. 104–4) also requires that
agencies assess anticipated costs and
benefits before issuing any rule whose
mandates require spending in any 1 year
$100 million in 1995 dollars, updated
annually for inflation. In 2013, that
threshold is approximately $141
million. This proposed rule does not
include any mandates that would
impose spending costs on State, local, or
Tribal governments in the aggregate, or
by the private sector, of $141 million.
XIII. Federalism Analysis
Executive Order 13132 on Federalism
(August 4, 1999) establishes certain
requirements that an agency must meet
when it promulgates a proposed rule
(and subsequent final rule) that imposes
substantial direct requirement costs on
State and local governments, preempts
State law, or otherwise has Federalism
implications. We have reviewed this
proposed rule under the threshold
criteria of Executive Order 13132,
Federalism, and have determined that it
will not have substantial direct effects
on the rights, roles, and responsibilities
of States, local or Tribal governments.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
XIV. Congressional Review Act
This proposed rule 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.
In accordance with the provisions of
Executive Order 12866, this proposed
rule was reviewed by the Office of
Management and Budget.
VerDate Mar<15>2010
18:07 Jul 05, 2013
Jkt 229001
This section lists the Addenda
referred to in the preamble of this
proposed rule. Beginning in CY 2012,
the Addenda for the annual ESRD PPS
proposed and final rulemakings will no
longer appear in the Federal Register.
Instead, the Addenda will be available
only through the Internet. We will
continue to post the Addenda through
the Internet.
Readers who experience any problems
accessing the Addenda that are posted
on the CMS Web site at https://
www.cms.gov/ESRDPayment/PAY/
list.asp, should contact Michelle Cruse
at (410) 786–7540.
PART 413—PRINCIPLES OF
REASONABLE COST
REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE
SERVICES; OPTIONAL
PROSPECTIVELY DETERMINED
PAYMENT RATES FOR SKILLED
NURSING FACILITIES
1. The authority citation for part 413
is revised to read as follows:
■
Authority: Secs. 1102, 1812(d), 1814(b),
1815, 1833(a), (i), and (n), 1861(v), 1871,
1881, 1883 and 1886 of the Social Security
Act (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 Pub. L. 106–113 (113 Stat. 1501A–
332), sec. 3201 of Pub. L. 112–96 (126 Stat.
156), and sec. 632 of Pub. L. 112–240 (126
Stat. 2354).
§ 413.174
[Amended]
2. Section 413.174 (f)(6) is amended
by removing ‘‘January 1, 2014’’ and by
adding in its place ‘‘January 1, 2016.
■
§ 413.237
[Amended]
3. Section 413.237(a)(1)(iv) is
amended by removing ‘‘excluding’’ and
by adding in its place ‘‘including’’; and
by removing ‘‘January 1, 2014’’ and
adding in its place ‘‘January 1, 2016’’.
■
PO 00000
Frm 00055
Fmt 4701
Sfmt 4702
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
4. The authority citation for part 414
continues to read as follows:
■
Authority: Secs. 1102, 1871, and 1881(b)(1)
of the Social Security Act (42 U.S.C. 1302,
1395hh, and 1395rr(b)(1)).
5. The heading for subpart C is revised
to read as follows:
■
Subpart C—Fee Schedules for
Parenteral and Enteral Nutrition (PEN)
Nutrients, Equipment and Supplies,
Splints, Casts, and Certain Intraocular
Lenses (IOLs)
■
Purpose.
General payment rules.
(a) General rule. For PEN items and
services furnished on or after January 1,
2002, and for splints and casts and IOLs
inserted in a physician’s office on or
after January 1, 2014, Medicare pays for
the items and services as described in
paragraph (b) of this section on the basis
of 80 percent of the lesser of—
*
*
*
*
*
(2) The fee schedule amount for the
item or service, as determined in
accordance with §§ 414.104 thru
414.108.
(b) * * *
(1) CMS or the carrier determines fee
schedules for parenteral and enteral
nutrition (PEN) nutrients, equipment,
and supplies, splints and casts, and
IOLs inserted in a physician’s office, as
specified in §§ 414.104 thru 414.108.
*
*
*
*
*
(c) Updating the fee schedule
amounts. For the years 2003 through
2010 for PEN items and services, the fee
schedule amounts of the preceding year
are updated by the percentage increase
in the CPI–U for the 12-month period
ending with June of the preceding year.
For each year subsequent to 2010 for
PEN items and services and for each
year subsequent to 2014 for splints and
casts, and IOLs inserted in a physician’s
office, the fee schedule amounts of the
preceding year are updated by the
percentage increase in the CPI–U for the
12-month period ending with June of
E:\FR\FM\08JYP2.SGM
08JYP2
40890
Federal Register / Vol. 78, No. 130 / Monday, July 8, 2013 / Proposed Rules
the preceding year, reduced by the
productivity adjustment described in
section 1886(b)(3)(B)(xi)(II) of the Act.
■ 8. Section 414.106 is added to read as
follows:
updated by the percentage increase in
the CPI–U for the 24-month period
ending with June of 2013.
■ 10. Revise the heading to Subpart D to
read as follows:
§ 414.106
Subpart D—Payment for Durable
Medical Equipment, Prosthetic and
Orthotic Devices, and Surgical
Dressings
Splints and casts.
(a) Payment rules. Payment is made in
a lump sum for splints and casts.
(b) Fee schedule amount. The fee
schedule amount for payment for an
item or service furnished in 2014 is the
reasonable charge amount for 2013,
updated by the percentage increase in
the CPI–U for the 12-month period
ending with June of 2013.
■ 9. Section 414.108 is added to read as
follows:
§ 414.108
office.
IOLs inserted in a physician’s
tkelley on DSK3SPTVN1PROD with PROPOSALS2
(a) Payment rules. Payment is made in
a lump sum for IOLs inserted in a
physician’s office.
(b) Fee schedule amount. The fee
schedule amount for payment for an IOL
furnished in 2014 is the national
average allowed charge for the IOL
furnished from in calendar year 2012,
VerDate Mar<15>2010
16:44 Jul 05, 2013
Jkt 229001
*
*
*
*
*
11. Section § 414.200 is revised to
read as follows:
■
§ 414.200
Purpose.
This subpart implements sections
1834(a), (h) and (i) of the Act by
specifying how payments are made for
the purchase or rental of new and used
durable medical equipment, prosthetic
and orthotic devices, and surgical
dressings for Medicare beneficiaries.
■ 12. Section 414.226 is amended by
revising paragraph (c)(6) to read as
follows:
§ 414.226
Oxygen and oxygen equipment.
*
*
PO 00000
*
Frm 00056
*
Fmt 4701
*
Sfmt 9990
(c) * * *
(6) Beginning in 2008, CMS makes an
annual adjustment to the national
limited monthly payment rate for items
described in paragraph (c)(1)(i) of this
section to ensure that such payment
rates do not result in expenditures for
any year that are more or less than the
expenditures that would have been
made if such classes had not been
established.
*
*
*
*
*
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: June 19, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: June 26, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2013–16107 Filed 7–1–13; 4:15 pm]
BILLING CODE 4120–01–P
E:\FR\FM\08JYP2.SGM
08JYP2
]]>Agencies
[Federal Register Volume 78, Number 130 (Monday, July 8, 2013)]
[Proposed Rules]
[Pages 40835-40890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16107]
[[Page 40835]]
Vol. 78
Monday,
No. 130
July 8, 2013
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 413 and 414
Medicare Program; End-Stage Renal Disease Prospective Payment System,
Quality Incentive Program, and Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies; Proposed Rule
Federal Register / Vol. 78 , No. 130 / Monday, July 8, 2013 /
Proposed Rules
[[Page 40836]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 413 and 414
[CMS-1526-P]
RIN 0938-AR55
Medicare Program; End-Stage Renal Disease Prospective Payment
System, Quality Incentive Program, and Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This rule proposes to update and make revisions to the End-
Stage Renal Disease (ESRD) prospective payment system (PPS) for
calendar year (CY) 2014. This rule also proposes to set forth
requirements for the ESRD quality incentive program (QIP), including
for payment year (PY) 2016 and beyond. In addition, this rule proposes
to clarify the grandfathering provision related to the 3-year minimum
lifetime requirement (MLR) for Durable Medical Equipment (DME). In
addition, it provides clarification of the definition of routinely
purchased DME. This rule also proposes the implementation of budget-
neutral fee schedules for splints and casts, and intraocular lenses
(IOLs) inserted in a physician's office. Finally, this rule would make
a few technical amendments and corrections to existing regulations
related to payment for DMEPOS items and services.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. E.S.T on August 30,
2013.
ADDRESSES: In commenting, please refer to file code CMS-1526-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1526-P, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1526-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period: a. For delivery in Washington, DC--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Room 445-G, Hubert H. Humphrey Building, 200
Independence Avenue SW., Washington, DC 20201
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Michelle Cruse, (410) 786-7540, for issues related to the ESRD PPS.
Stephanie Frilling, (410) 786-4507, for issues related to the ESRD PPS
wage index, home dialysis training, and the delay in payment for oral-
only drugs under the ESRD PPS.
Heidi Oumarou, (410) 786-7942, for issues related to the ESRD market
basket.
Anita Segar, (410) 786-4614, for issues related to the ESRD QIP.
Sandhya Gilkerson, (410) 786-4085, for issues related to the
clarification of the grandfathering provision related to the 3-year MLR
for DME.
Anita Greenberg (410) 786-4601, for issues related to the clarification
of the definition of routinely purchased DME.
Christopher Molling (410) 786-6399, for issues related to DMEPOS
technical amendments and corrections.
Hafsa Vahora, (410) 786-7899, for issues related to the implementation
of budget neutral fee schedules for splints and casts, and IOLs
inserted in a physician's office.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Electronic Access
This Federal Register document is also available from the Federal
Register online database through Federal Digital System (FDsys), a
service of the U.S. Government Printing Office. This database can be
accessed via the internet at https://www.gpo.gov/fdsys/.
Addenda Are Only Available Through the Internet on the CMS Web site
In the past, a majority of the Addenda referred to throughout the
preamble of our proposed and final rules were available in the Federal
Register. However, the Addenda of the annual proposed and final rules
will no longer be available in the Federal Register. Instead, these
Addenda to the annual proposed and final rules will be available only
through the Internet on the CMS Web site. The Addenda to the End-Stage
Renal Disease (ESRD) Prospective Payment System (PPS) rules are
available at: https://www.cms.gov/ESRDPayment/PAY/list.asp. Readers who
experience any problems accessing any of the Addenda to the proposed
and final rules of the ESRD PPS that are posted on the CMS Web site
identified
[[Page 40837]]
above should contact Michelle Cruse at 410-786-7540.
Table of Contents
To assist readers in referencing sections contained in this
preamble, we are providing a Table of Contents. Some of the issues
discussed in this preamble affect the payment policies, but do not
require changes to the regulations in the Code of Federal Regulations
(CFR).
I. Executive Summary
A. Purpose
1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)
2. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP)
3. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS)
B. Summary of the Major Provisions
1. ESRD PPS
2. ESRD QIP
3. DMEPOS
C. Summary of Costs and Benefits
1. Impacts of the Proposed ESRD PPS
2. Impacts for ESRD QIP
3. Impacts for DMEPOS
II. Calendar Year (CY) 2013 End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS)
A. Background on the End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS)
B. Routine Updates and Proposed Policy Changes to the CY 2014 ESRD
PPS
1. Composite Rate Portion of the ESRD PPS Blended Payment
2. ESRD PPS Base Rate
a. Proposed Adjustment to the ESRD PPS Base Rate to Reflect
Change in Utilization of ESRD-Related Drugs and Biologicals
i. Methodology for Reducing the CY 2014 ESRD PPS Base Rate
ii. Determining Utilization of ESRD-Related Drugs and
Biologicals
iii. Pricing of ESRD-Related Drugs and Biologicals
iv. Calculation of the Amount of the Per Treatment Reduction
v. Comparison of ASP versus PPI
3. ESRD Bundled Market Basket
a. Overview and Background
b. Proposed Market Basket Update Increase Factor and Labor-
related Share for ESRD Facilities for CY 2014
c. Proposed Productivity Adjustment
d. Calculation of the ESRDB Market Basket Update, Adjusted for
Multifactor Productivity for CY 2014
4. The Proposed CY 2014 Wage Index
a. Payment Under the ESRD PPS for Facilities Located in Guam,
American Samoa, and the Northern Mariana Islands and Proposed Wage
Index Value for Guam
b. Proposed Policies for Areas with No Wage Data
c. Proposed Reduction to the ESRD Wage Index Floor
d. Proposed Wage Index Budget-Neutrality Adjustment
5. Application of the International Classification of Diseases
(ICD), Tenth Revision, to the Comorbidity Payment Adjustment Codes
a. One ICD-9-CM Code Crosswalks to One ICD-10-CM Code
b. One ICD-9-CM Code Crosswalks to Multiple ICD-10-CM Codes
c. Multiple ICD-9-CM Codes Crosswalk to One ICD-10-CM Code
6. Proposed Revisions to the Outlier Policy
a. Impact of Proposed Changes to the Outlier Policy
b. Outlier Policy Percentage
C. Discussion of Self-Dialysis and Home Dialysis Training Add On
Adjustment and Request for Public Comments
a. Medicare Policy for Self-Dialysis Training, Home Dialysis
Training, and Retraining
b. Payment Methodology
D. Delay of Payment for Oral-Only Drugs Under the ESRD PPS
III. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP)
A. Background
B. Considerations in Updating and Expanding Quality Measures
under the ESRD QIP for PY 2016 and Subsequent PYs
1. Value-Based Purchasing (VBP) Overview
2. Brief Overview of Proposed PY 2016 Measures
3. Measures Application Partnership Review
C. Proposed Measures for the PY 2016 ESRD QIP and Subsequent PYs
of the ESRD QIP
1. PY 2015 Measures Continuing in PY 2016 and Future Payment
Years
2. Proposal to Expand One PY 2015 Measure and Revise Two PY 2015
Measures for PY 2016 and Subsequent Payment Years
a. Proposed Expanded ICH CAHPS Reporting Measure
b. Proposed Revised Mineral Metabolism Reporting Measure
c. Proposed Revised Anemia Management Reporting Measure
3. New Measures Proposed for PY 2016 and Subsequent Payment
Years of the ESRD QIP
a. Proposed Clinical Anemia Management Measure and Anemia
Management Clinical Measure Topic
i. Anemia Management: Hgb > 12
ii. Anemia of Chronic Kidney Disease: Patient Informed Consent
for Anemia Treatment
b. Hypercalcemia
c. Use of Iron Therapy for Pediatric Patients Reporting Measure
d. NHSN Bloodstream Infection in Hemodialysis Outpatients
Clinical Measure
e. Comorbidity Reporting Measure
4. Other Measures under Development
5. Proposed Scoring for the PY 2016 ESRD QIP and Future Payment
Years
6. Proposed Performance Period for the PY 2016 ESRD QIP
7. Proposed Performance Standards for the PY 2016 ESRD QIP and
Future Payment Years
a. Proposed Clinical Measure Performance Standards
b. Estimated Performance Standards for Proposed Clinical
Measures
c. Proposed Performance Standards for Reporting Measures
8. Proposed Scoring for the PY 2016 ESRD QIP Proposed Measures
a. Proposals for Scoring Facility Performance on Clinical
Measures Based on Achievement
b. Proposals for Scoring Facility Performance on Clinical
Measures Based on Improvement
c. Proposals for Calculating Facility Performance on Reporting
Measures
9. Proposals for Weighting the PY 2016 ESRD QIP Measures and
Calculating the PY 2016 ESRD QIP Total Performance Score
a. Weighting Individual Measures to Compute Measure Topic Scores
for the Kt/V Dialysis Adequacy measure topic, the Vascular Access
Type measure topic, and the Anemia Management Clinical measure topic
b. Proposal for Weighting the Total Performance Score
c. Examples of the Proposed PY 2016 ESRD QIP Scoring Methodology
10. Proposed Minimum Data for Scoring Measures for the PY 2016
ESRD QIP and Future Payment Years
11. Proposed Payment Reductions for the PY 2016 ESRD QIP and
Future Payment Years
12. Data Validation
13. Proposals for Scoring Facilities Whose Ownership has Changed
14. Proposals for Public Reporting Requirements
IV. Clarification of the Definition of Routinely Purchased Durable
Medical Equipment (DME)
A. Background
1. Background for DME
2. Medicare Guidance and Rulemaking Regarding Definition of
Routinely Purchased DME
3. Payment for Inexpensive or Routinely Purchased Items and
Capped Rental Items
B. Current Issues
C. Classification of Items under the Existing Regulations and
Definition of Routinely Purchased Equipment
V. Clarification of the 3-year Minimum Lifetime Requirement (MLR)
for DME
A. Background
B. Current Issues
C. Scope of the 3-Year MLR
VI. Implementation of Budget-Neutral Fee Schedules for Splints,
Casts and Intraocular Lenses (IOLs)
A. Background
1. Payment Under Reasonable Charges
2. Payment Under Fee Schedules
B. Provisions of the Proposed Regulations
VII. DMEPOS Technical Amendments and Corrections
A. Background
B. Proposed Technical Amendments and Corrections
VIII. Collection of Information Requirements
A. Legislative Requirement for Solicitation of Comments
B. Requirements in Regulation Text
C. Additional Information Collection Requirements
1. ESRD QIP
a. Proposed Expanded ICH CAHPS Reporting Measure for PY 2016 and
Future Payment Years of the ESRD QIP
[[Page 40838]]
b. Proposed Data Validation Requirements for the PY 2016 ESRD
QIP
2. Clarification of the Definition of Routinely Purchased
Durable Medical Equipment
3. Clarification of the 3-year Minimum Lifetime Requirement for
DME
4. Implementation of Budget-Neutral Fee Schedules for Splints,
Casts and Intraocular Lenses
IX. Response to Comments
X. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
2. Statement of Need
3. Overall Impact
B. Detailed Economic Analysis
1. CY 2014 End-Stage Renal Disease Prospective Payment System
a. Effects on ESRD Facilities
b. Effects on Other Providers
c. Effects on the Medicare Program
d. Effects on Medicare Beneficiaries
e. Alternatives Considered
2. End-Stage Renal Disease Quality Incentive Program
a. Effects of the PY 2016 ESRD QIP
b. Alternatives Considered for the PY 2016 ESRD QIP
3. DMEPOS Provisions
a. Effects of the Implementation of Fee Schedules for Splints,
Casts and IOLs
b. Clarification of the 3-year MLR
c. Definition of Routinely Purchased DME
C. Accounting Statement.
XI. Regulatory Flexibility Act Analysis
XII. Unfunded Mandates Reform Act Analysis
XIII. Federalism Analysis
XIV. Congressional Review Act
XV. Files Available to the Public via the Internet
Regulations Text
Acronyms
Because of the many terms to which we refer by acronym in this
final rule, we are listing the acronyms used and their corresponding
meanings in alphabetical order below:
AHRQ Agency for Healthcare Research and Quality
ASP Average Sales Price
BLS Bureau of Labor Statistics
CBSA Core based statistical area
CCN CMS Certification Number
CDC Centers for Disease Control and Prevention
CKD Chronic Kidney Disease
CY Calendar Year
DFC Dialysis Facility Compare
DME Durable Medical Equipment
DMEPOS Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies
ESA Erythropoiesis stimulating agent
ESRD End-Stage Renal Disease
ESRDB End-Stage Renal Disease bundled
ESRD PPS End-Stage Renal Disease Prospective Payment System
FDA Food and Drug Administration
GEM General Equivalence Mappings
HAIs Healthcare-Acquired Infections
HCPCS Healthcare Common Procedure Coding System
HHS Department of Health and Human Services
ICD International Classification of Diseases
ICD-9-CM International Classification of Disease, 9th Revision,
Clinical Modification
ICH CAHPS In-Center Hemodialysis Consumer Assessment of Healthcare
Providers and Systems
IGI IHS Global Insight
IOLs Intraocular Lenses
IPPS Inpatient Prospective Payment System
MAP Medicare Allowable Payment
MFP Multifactor Productivity
MLR Minimum Lifetime Requirement
NHSN National Health Safety Network
NQF National Quality Forum
OMB Office of Management and Budget
PFS Physician Fee Schedule
QIP Quality Incentive Program
SHR Standardized Hospitalization Ratio Admissions
SMR Standardized Mortality Ratio
TPS Total Performance Score
VBP Value Based Purchasing
I. Executive Summary
A. Purpose
1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)
On January 1, 2011, we implemented the ESRD PPS, a case-mix
adjusted bundled prospective payment system for renal dialysis services
furnished by ESRD facilities. Effective January 1, 2014, the transition
to the ESRD PPS will conclude and all Medicare ESRD facilities will be
paid 100 percent under the ESRD PPS. This rule proposes to update and
make revisions to the End-Stage Renal Disease (ESRD) prospective
payment system (PPS) for calendar year (CY) 2014. In accordance with
section 1881(b)(14) of the Social Security Act (the Act), as added by
section 153(b) of the Medicare Improvements for Patients and Providers
Act of 2008 (MIPPA) (Public Law 110-275), and section 1881(b)(14)(F) of
the Act, as added by section 153(b) of MIPPA and amended by section
3401(h) of the Affordable Care Act (ACA) (Pub. L. 111-148), established
that beginning CY 2012, and each subsequent year, the Secretary shall
reduce the market basket increase factor by a productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act.
In addition, section 1881(b)(14)(I) of the Act, as added by section
632(a) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-
240) requires the Secretary, by comparing per patient utilization from
2007 with such data from 2012, to reduce the single payment amount to
reflect the Secretary's estimate of the change in the utilization of
ESRD-related drugs and biologicals. Section 632(b) of ATRA prevents the
Secretary from paying for oral-only ESRD-related drugs and biologicals
under the ESRD PPS before January 1, 2016.
2. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP)
This rule also proposes to set forth requirements for the ESRD
Quality Incentive Program (QIP), including for payment year (PY) 2016.
The program is authorized under section 153(c) of MIPPA, which added
section 1881(h) to the Social Security Act (the Act). The ESRD QIP is
the most recent step in fostering improved patient outcomes by
establishing incentives for dialysis facilities to meet performance
standards established by CMS.
3. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS)
This rule would clarify the definition of routinely purchased
equipment covered under the DME benefit category and the scope of the
3-year minimum lifetime requirement (MLR) for DME. In addition, this
rule proposes to implement budget neutral fee schedules for splints and
casts as well as intraocular lenses (IOLs) inserted in a physician's
office. Finally, this rule would make a few technical amendments and
corrections to existing regulations related to payment for DMEPOS items
and services.
B. Summary of the Major Provisions
1. ESRD PPS
Update to the ESRD PPS base rate for CY 2014: For CY 2014,
we propose an ESRD PPS base rate of $216.95. This amount reflects the
application of the proposed ESRD bundled (ESRDB) market basket reduced
by the productivity adjustment, or 2.5 percent, the wage index budget-
neutrality adjustment factor of 1.000411, and the drug utilization
adjustment to the CY 2013 ESRD PPS base rate of $240.36. The proposed
CY 2014 ESRDB market basket increase factor is 2.9 percent. The current
forecast of the proposed CY 2014 productivity adjustment is 0.4
percent. The proposed drug utilization adjustment factor to account for
changes in utilization as required by section 1881(b)(14)(I) is -12
percent.
Updates to the wage index and wage index floor: We adjust
wage indices on an annual basis using the most current hospital wage
data to account for differing wage levels in areas in which ESRD
facilities are located. In CY 2014, we are not proposing any changes to
the application of the wage index budget-neutrality adjustment factor
and will continue to apply the budget-neutrality
[[Page 40839]]
adjustment to the base rate for the ESRD PPS. We have been gradually
decreasing the wage index floor by .05 in an effort to gradually phase
out the floor. For CY 2014 and CY 2015 we are proposing to continue our
policy for the gradual phase out of the wage index floor and to reduce
the wage index floor values to 0.45 and 0.40, respectively.
Update to the outlier policy: We are updating the outlier
services fixed dollar loss amounts for adult and pediatric patients and
Medicare Allowable Payments (MAPs) for adult patients for CY 2014 using
2012 claims data. Based on the use of more current data, the fixed-
dollar loss amount for pediatric beneficiaries would increase from
$47.32 to $54.23 and the MAP amount would remain $38.65 as compared to
CY 2013 values. For adult beneficiaries, the fixed-dollar loss amount
would decrease from $110.22 to $94.26 and the MAP amount would decrease
from $61.38 to $52.45. The 1 percent target for outlier payments was
not achieved in CY 2012. We believe using CY 2012 claims data to update
the outlier MAP and fixed dollar loss amounts for CY 2014 will increase
payments for ESRD beneficiaries requiring higher resource utilization
in accordance with a 1 percent outlier percentage.
Application of ICD-10-CM Diagnosis Codes to the
comorbidity payment adjustment codes: Effective October 1, 2014, CMS
will implement the 10th revision of the ICD coding scheme. We discuss
and provide a crosswalk from ICD-9-CM to ICD-10-CM for codes that are
subject to the comorbidity payment adjustment. We propose that all ICD-
10-CM codes to which ICD-9-CM codes that are eligible for the
comorbidity payment adjustment crosswalk will be eligible for the
comorbidity payment adjustment with two exceptions.
2. ESRD QIP
This proposed rule proposes to implement requirements for the ESRD
QIP. With respect to the PY 2016 ESRD QIP, we propose to continue some
of the previous ESRD QIP measures, add new measures, and expand the
scope of some of the existing measures to cover the measure topics as
follows:
To evaluate anemia management:
[cir] Hemoglobin Greater Than 12 g/dL, a clinical measure
[cir] Patient Informed Consent for Anemia Treatment, a clinical
measure*
[cir] Anemia Management, a reporting measure[dagger]
[cir] Pediatric Iron Therapy, a reporting measure*
To evaluate dialysis adequacy:
[cir] A Kt/V measure for adult hemodialysis patients, a clinical
measure
[cir] A Kt/V measure for adult peritoneal dialysis patients, a
clinical measure
[cir] A Kt/V measure for pediatric hemodialysis patients, a
clinical measure
To determine whether patients are treated using the most
beneficial type of vascular access:
[cir] An arteriovenous fistula measure, a clinical measure
[cir] A catheter measure, a clinical measure
To address effective bone mineral metabolism management:
[cir] Hypercalcemia, a clinical measure*
[cir] Mineral Metabolism, a reporting measure[dagger]
To address safety:
[cir] National Healthcare Safety Network (NHSN) Bloodstream
Infection in Hemodialysis Outpatients, a clinical measure*
To assess patient experience:
[cir] ICH CAHPS survey reporting measure[Dagger]
To gather data regarding comorbidities:
[cir] Comorbidity, a reporting measure*
* Denotes that this measure is new to the ESRD QIP.
[dagger] Denotes that this measure is revised in the ESRD
QIP.
[Dagger] Denotes that this measure is expanded in the ESRD
QIP.
It also proposes to establish CY 2014 as the performance period for
the PY 2016 ESRD QIP, establish performance standards for each measure,
and adopt scoring and payment reduction methodologies that are similar
to those finalized for the PY 2015 ESRD QIP.
3. DMEPOS
Definition of routinely purchased DME: This rule would
clarify the definition of routinely purchased DME set forth at section
Sec. 414.220(a), as well as address the classification of and payment
for expensive items of DME and accessories (over $150) as a capped
rental items in accordance with Sec. 414.229, if the items were not
acquired by purchase on a national basis at least 75 percent of the
time during the period July 1986 through June 1987.
Clarification of to the 3-year MLR and Related
Grandfathering Policy: This rule would provide further clarification
about how we would apply the 3-year minimum lifetime requirement (MLR)
set forth at Sec. 414.202, which must be satisfied for an item or
device to be considered durable medical equipment.
Implementation of budget neutral fee schedules for splints
and casts, and IOLs inserted in a physician's office: For CY 2014, we
are proposing to implement budget neutral fee schedule amounts for
splints, casts, and IOLs inserted in a physician's office. Section
1842(s) of the Act authorizes CMS to implement fee schedule amounts for
these items if they established so that they are initially budget
neutral. In 2011, total allowed charges for splints and casts were $5.6
million, while total allowed charges for intraocular lenses inserted in
a physician's office were $76 thousand.
C. Summary of Costs and Benefits
In section X.B. of this proposed rule, we set forth a detailed
analysis of the impacts that the proposed changes would have on
affected entities and beneficiaries. The impacts include the following:
1. Impacts of the Proposed ESRD PPS
The impact chart in section X.B.1. of this proposed rule displays
the estimated change in payments to ESRD facilities in CY 2014 compared
to estimated payments in CY 2013. The overall impact of the CY 2014
changes is projected to be a 9.4 percent decrease in payments.
Hospital-based ESRD facilities have an estimated 9.3 percent decrease
in payments compared with freestanding facilities with an estimated 9.4
percent decrease.
We estimate that the aggregate ESRD PPS expenditures would decrease
by approximately $780 million from CY 2013 to CY 2014. This reflects a
$210 million increase from the payment rate update, a $30 million
increase due to the updates to the outlier threshold amounts, and a
$1.02 billion decrease in expenditures specifically related to the -12
percent drug utilization adjustment required by section 1881(b)(14)(I).
The estimated 9.4 percent overall payment decrease would result in a
$190 million savings to beneficiaries.
2. Impacts for ESRD QIP
The overall economic impact of the proposed ESRD QIP is an
estimated $26.4 million in PY 2016. In PY 2016, we expect the total
payment reductions to be approximately $26.4 million, and the costs
associated with the collection of information requirements for certain
measures to be approximately $39.5 thousand. For PY 2017 and future
payment years, we expect the costs associated with the collection of
information requirements for the expanded ICH CAHPS measure in the
proposed ESRD QIP to be approximately $9.7 million.
The ESRD QIP will continue to incentivize facilities to provide
higher
[[Page 40840]]
quality care to beneficiaries. The reporting measures associated with
the collection of information requirements are critical to better
understanding the quality of care beneficiaries receive, particularly
patients' experience of care, and will be used to incentivize
improvements in the quality of care provided.
3. Impacts for DMEPOS
The overall impact of the DMEPOS proposal to implement fee
schedules for splints and casts and IOLs inserted in a physician's
office is insignificant. The reasonable charge amounts that we propose
to convert to fee schedule amounts would be budget neutral the first
year and would be updated annually thereafter based on the consumer
price index for all consumers (CPI-U) for the 12-month period ending
June 30 of the previous year and, reduced by the productivity
adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. For
the 3-year MLR, we believe that a vast majority of the categories of
items that were classified as DME before January 1, 2012, did function
for 3 or more years (76 FR 70289). The 3-year MLR is designed to
represent a minimum threshold for determination of durability for
equipment that is consistent with the statutory DME payment provisions
and applies on a prospective basis, effective January 1, 2012. CMS
recognizes that the healthcare industry and beneficiaries have come to
rely on items that have qualified as DME on or prior to January 1,
2012, regardless of whether those items met the 3-year MLR set forth at
Sec. 414.202. We note that given that reliance and consistent with the
regulation at Sec. 414.202, CMS will not reopen those prior decisions
and reclassify the equipment in light of the new 3-year standard. We
believe that continuing the Medicare coverage for all the items that
qualified as DME on or prior to January 1, 2012, could avoid disrupting
the continuity of care for the beneficiaries that received these items
for medical treatment prior to January 1, 2012, without creating a
significant fiscal impact on the Medicare Program.
We expect that the overall impact of reaffirming the definition of
routinely purchased DME and our proposal for classifying certain
expensive items as cap rental would be a decrease in expenditures
because payment on a 13-month capped rental basis rather than a lump
sum purchase basis for certain, very expensive items would lower total
payments for these items and because many beneficiaries would not rent
the items for as long as 13 months.
II. Calendar Year (CY) 2014 End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS)
A. Background on the End-Stage Renal Disease (ESRD) Prospective Payment
System (PPS)
On August 12, 2010, we published in the Federal Register a final
rule (75 FR 49030 through 49214) titled, ``End-Stage Renal Disease
Prospective Payment System'', hereinafter referred to as the CY 2011
ESRD PPS final rule. In the CY 2011 ESRD PPS final rule, we implemented
a case-mix adjusted bundled PPS for Medicare outpatient ESRD dialysis
services beginning January 1, 2011, in accordance with section
1881(b)(14) of the Act, as added by section 153(b) of MIPPA.
On November 10, 2011, we published in the Federal Register, a final
rule (76 FR 70228 through 70316) titled, ``Medicare Program; End-Stage
Renal Disease Prospective Payment System and Quality Incentive Program;
Ambulance Fee Schedule; Durable Medical Equipment; and Competitive
Acquisition of Certain Durable Medical Equipment, Prosthetics,
Orthotics and Supplies'' (hereinafter referred to as the CY 2012 ESRD
PPS final rule). In that final rule, for the ESRD PPS, we made a number
of routine updates for CY 2012, implemented the second year of the
transition to the ESRD PPS, made several policy changes and
clarifications, and made technical changes.
On November 9, 2012, we published in the Federal Register, a final
rule (77 FR 67450 through 67531) titled, ``Medicare Program; End-Stage
Renal Disease Prospective Payment System, Quality Incentive Program,
and Bad Debt Reductions for All Medicare Providers'' (hereinafter
referred to as the CY 2013 ESRD PPS final rule). In that final rule,
for the ESRD PPS, we made a number of routine updates for CY 2013,
implemented the third year of the transition to the ESRD PPS, and made
several policy changes and reiterations. In that rule, we finalized the
following:
An ESRD PPS base rate of $240.36 per treatment for renal
dialysis services. The ESRD PPS base rate applies to the ESRD PPS
portion of the blended payments during the transition and to the ESRD
PPS payments. This amount reflected the CY 2013 ESRD bundled (ESRDB)
market basket update of 2.9 percent minus a multifactor productivity
adjustment of 0.6 percent, that is, a 2.3 percent increase. This amount
also reflected the application of the wage index budget-neutrality
adjustment of 1.000613.
A composite base rate of $145.20 per treatment for renal
dialysis services that is used in the composite rate portion of the
ESRD PPS payment for ESRD facilities receiving blended payments during
the transition. This amount reflected the application of the ESRDB
market basket reduced by the multifactor productivity adjustment, or a
2.3 percent increase.
A zero update to the drug add-on adjustment and
maintaining the $20.33 per treatment drug add-on amount for the
composite rate portion of the ESRD PPS blended payment. This resulted
in a 14.0 percent drug add-on adjustment to the composite rate portion
of the ESRD PPS blended payment.
A 0.1 percent transition budget-neutrality adjustment
factor.
A 1.001141 wage index budget-neutrality adjustment factor
for the composite portion of the ESRD PPS blended payment, which is
applied to the wage index values.
A 1.000613 wage index budget-neutrality adjustment factor
for the ESRD PPS portion of the blended payment and for the ESRD PPS,
which is applied to the ESRD PPS base rate.
A 0.05 reduction to the wage index floor which resulted in
a wage index floor of 0.500 under the ESRD PPS.
A 0.501 wage index floor under the composite rate portion
of the blended payment (1.500 x 1.001141 = 0.501).
Revisions to the outlier policy. Specifically, for
pediatric beneficiaries, a fixed-dollar loss amount of $47.32 and a
Medicare Allowable Payment (MAP) amount of $41.39. For adult
beneficiaries, a fixed-dollar loss amount of $110.22 and a MAP amount
of $59.42.
Eliminating the restriction on daptomycin to allow ESRD
facilities to receive separate payment by appending the AY modifier on
the claim for daptomycin when the diagnosis reported on the claim
indicates the drug was used to treat a non-ESRD related condition.
Excluding alteplase and other thrombolytics from separate
payment for the composite rate portion of blended payments during the
remainder of the transition.
Use of the Average Sales Price (ASP) methodology,
including any modifications finalized in the Physician Fee Schedule
(PFS) final rules, to compute outlier MAP amounts, the drug add-on, and
any other policy that requires the use of payment amounts for drugs and
biologicals that would be separately paid absent the ESRD PPS and for
the composite rate portion of the blended payment during the
transition.
[[Page 40841]]
Finally, in the CY 2013 ESRD PPS final rule, we reiterated policies
regarding the following billing practices because we believed that ESRD
facilities may be billing renal dialysis services for separate payment:
Any item or service included in the composite rate should
not be identified on ESRD claims.
An AY modifier can be appended to claims for drugs and
laboratory tests that are not ESRD-related to allow for separate
payment. The AY modifier should not be used for renal dialysis services
and we have monitoring efforts in place to analyze billing trends.
B. Routine Updates and Proposed Policy Changes to the CY 2014 ESRD PPS
1. Composite Rate Portion of the ESRD PPS Blended Payment
Section 1881(b)(14)(E)(i) of the Act requires a 4-year transition
under the ESRD PPS. We are proposing to implement the fourth year of
the transition for those ESRD facilities that did not elect to receive
100 percent of the payment amount under the ESRD PPS. For CY 2014,
under 42 CFR 413.239(a)(4), 100 percent of the payment amount will be
determined in accordance with section 1881(b)(14). Accordingly, a
blended rate will no longer be provided, all facilities will be paid
100 percent under the ESRD PPS, and there will no longer be a
transition budget neutrality adjustment factor applied to these
payments starting on January 1, 2014. Therefore, facilities that
participate in the transition will no longer receive a portion of their
payments based on the basic case-mix adjusted composite rate payment
system. Because payments will no longer be based on the basic case-mix
adjusted composite rate, we will not update the drug add-on or wage
index values (which included a budget neutrality adjustment factor)
that comprised that rate. In this proposed rule we only discuss updates
and policy changes that affect the components of the ESRD PPS.
2. ESRD PPS Base Rate
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), we
discussed the development of the ESRD PPS per treatment base rate that
is codified in the Medicare regulations at Sec. 413.220 and Sec.
413.230. The CY 2011 ESRD PPS final rule also provides a detailed
discussion of the methodology used to calculate the ESRD PPS base rate
and the computation of factors used to adjust the ESRD PPS base rate
for projected outlier payments and budget-neutrality in accordance with
sections 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) of the Act,
respectively. Specifically, the ESRD PPS base rate was developed from
CY 2007 claims (that is, the lowest per patient utilization year as
required by section 1881(b)(14)(A)(ii) of the Act), updated to CY 2011,
and represented the average per treatment Medicare Allowable Payment
(MAP) for composite rate and separately billable services. In
accordance with section 1881(b)(14)(D) of the Act and codified in
regulations at Sec. 413.230, the ESRD PPS base rate is adjusted for
the patient-specific case-mix adjustments, applicable facility
adjustments, geographic differences in area wage levels using an area
wage index, as well as applicable outlier payments or training
payments.
As discussed in section II.B.3., section 1881(b)(14)(F)(i) of the
Act, as added by section 153(b) of MIPPA and amended by section 3401(h)
of the Affordable Care Act, provides that, beginning in 2012, the ESRD
PPS payment amounts are required to be annually increased by the rate
of increase in the ESRD market basket, reduced by the productivity
adjustment described in section 1886(b)(3)(B)(xi)(II). Accordingly, for
this proposed rule, we applied the 2.5 percent increase to the CY 2013
ESRD PPS base rate of $240.36, which results in a proposed CY 2014 ESRD
PPS base rate of $246.37 ($240.36 x 1.025 = $246.37).
In addition, as discussed in section II.B.4.d. of this proposed
rule, for CY 2014 we are applying the wage index budget-neutrality
adjustment factor of 1.000411 to the CY 2014 ESRD PPS base rate (that
is, $246.37), yielding a proposed CY 2014 ESRD PPS wage-index budget-
neutrality adjusted base rate of $246.47 ($246.37 x 1.000411 =
$246.47).
a. Proposed Adjustment to the ESRD PPS Base Rate to Reflect Change in
Utilization of ESRD-Related Drugs and Biologicals
Section 1881(b)(14)(I) of the Act, as added by section 632(a) of
the American Taxpayer Relief Act of 2012 (ATRA), requires that, for
services furnished on or after January 1, 2014, the Secretary shall
make reductions to the single payment for renal dialysis services to
reflect the Secretary's estimate of the change in the utilization of
ESRD-related drugs and biologicals (excluding oral-only ESRD-related
drugs) by comparing per patient utilization data from 2007 with such
data from 2012. Section 1881(b)(14)(I) further requires that in making
the reductions, the Secretary take into account the most recently
available data on Average Sales Prices (ASP) and changes in prices for
drugs and biologicals reflected in the ESRD market basket percentage
increase factor under section 1881(b)(14)(F). Consistent with these
requirements, we propose to apply a payment adjustment to the CY 2014
ESRD PPS base rate that reflects the change in utilization of ESRD-
related drugs and biologicals from CY 2007 to CY 2012.
i. Methodology for Reducing the CY 2014 ESRD PPS Base Rate
We are proposing an adjustment that would reduce the ESRD PPS base
rate. Because the ESRD PPS base rate is a per treatment base rate, the
adjustment would be calculated on a per treatment basis. We propose to
calculate the amount of the per treatment adjustment by applying CY
2014 prices for ESRD-related drugs and biologicals to the utilization
data for CY 2007 and CY 2012. We note the CY 2014 ESRD PPS base rate is
reflective of 2007 utilization because the base rate is based on CY
2007 data. We believe using prices for drugs and biologicals inflated
to 2014 levels allows us to appropriately measure changes that are
attributable to utilization patterns as opposed to differences in
pricing for drugs and biologicals in 2007 and 2012. In addition, we
believe that because we are proposing to make the reduction in CY 2014,
we should price the ESRD-related drugs and biologicals for the year in
which the adjustment applies. For purposes of this analysis, we view
utilization of drugs and biologicals as units of a drug or biological
furnished to a patient per treatment for ESRD. We would take the
estimated amount of the per treatment difference between the estimated
spending of drugs and biologicals in CY 2007 and CY 2012 and reduce
this amount by the same adjustment factors that were used to calculate
the ESRD PPS base rate from the CY 2007 unadjusted rate per treatment,
which are the standardization, outlier, and the 98 percent budget-
neutrality adjustments. A detailed explanation of these adjustment
factors is provided in the CY 2011 ESRD PPS final rule (75 FR 49081
through 49082). We propose to reduce the CY 2014 ESRD PPS base rate by
the resulting amount.
ii. Determining Utilization of ESRD-Related Drugs and Biologicals
Section 1881(b)(14)(I) requires the single payment amount to be
reduced by an amount that ``reflects the Secretary's estimate of the
change in utilization of drugs and biologicals described in clauses
(ii), (iii), and (iv) of subparagraph (B) (other than oral-only
[[Page 40842]]
ESRD-related drugs, as such term is used in the final rule promulgated
by the Secretary in the Federal Register on August 12, 2010 (75 FR
49030))''. As we mentioned above, for purposes of this analysis, we
view utilization of drugs and biologicals as units of a drug or
biological furnished to a patient per treatment. ESRD facilities report
this information on claims. To calculate this adjustment, we analyzed
the utilization of erythropoiesis stimulating agents (ESAs) and any
oral forms of such agents furnished to individuals for the treatment of
ESRD. We also analyzed the utilization of other injectable drugs and
biologicals (such as iron sucrose and doxercalciferol) and any oral
equivalent form of such drug or biological furnished to individuals for
the treatment of ESRD that were included in the expanded bundle of
services covered by the ESRD PPS. We did not include diagnostic
laboratory tests or other items and services in the comparison analysis
because section 1811(b)(14)(I) only refers to estimating the change in
utilization of drugs and biologicals.
Section 1881(b)(14)(I) of the Act requires the Secretary to compare
per patient utilization data from 2007 with per patient utilization
data from 2012. For the CY 2007 utilization data for ESRD-related drugs
and biologicals, we propose to use the data analysis prepared for the
CY 2011 ESRD PPS final rule. In the CY 2011 ESRD PPS final rule (75 FR
49071 through 49083) we discuss in detail the development of the ESRD
PPS base rate and as we stated above, the base rate represents the
average MAP for composite rate and separately billable services which
was based on 2007 claims data. We explain in the CY 2011 ESRD PPS final
rule that in order to comply with section 1881(b)(14)(A)(ii) of the Act
we determined that 2007 was the year with the lowest per patient
utilization of renal dialysis services by Medicare ESRD beneficiaries
among the years 2007, 2008, and 2009. Therefore, utilization data for
ESAs and other drugs and biologicals including the oral-equivalent
forms of those drugs and biologicals furnished for the treatment of
ESRD was readily available for purposes of analyzing 2007 utilization.
For the CY 2012 utilization data for ESRD-related drugs and
biologicals, we propose to use the latest available claims data based
on the CY 2012 ESRD facility claims updated through December 31, 2012
(that is, claims with dates of service from January 1 through December
31, 2012, that were received, processed, paid, and passed to the
National Claims History File as of December 31, 2012). For the CY 2014
ESRD PPS final rule, we will use the CY 2012 claims file updated
through June 30, 2013, (that is, claims with dates of service from
January 1 through December 31, 2012, that were received, processed,
paid, and passed to the National Claims History File as of June 30,
2013) to calculate 2012 utilization. We solicit comments on the
proposed use of 2007 and 2012 claims data to capture the utilization of
ESRD-related drugs and biologicals in those years.
Because section 1881(b)(14)(I) requires that we compare per patient
utilization of ESRD-related drugs and biologicals in 2007 with per
patient utilization in 2012, we believe that this would also include
utilization of drugs and biologicals furnished in ESRD facilities
located in the United States Territories of Guam, American Samoa and
the Northern Mariana Islands (the Pacific Rim), even though facilities
in the Pacific Rim were not paid under the ESRD PPS during these years.
Therefore, we propose to use 2007 and 2012 utilization of ESRD-related
drugs and biologicals (including oral equivalents) for ESRD facilities
located in these territories in our analysis of the reduction required
by section 1881(b)(14)(I). For this proposed rule, we did not readily
have access to the 2007 utilization data for the ESRD facilities
located in these areas; however, we plan to include these data in our
calculation for the final rule. Because there are very few ESRD
facilities in this region, we do not believe that the inclusion of
utilization of drugs and biologicals furnished in CY 2007 at these
facilities will have a significant impact on the amount of the
adjustment. We solicit comments on the proposal to include data on the
utilization of drugs and biologicals furnished in ESRD facilities
located in the Pacific Rim when comparing utilization of drugs and
biologicals in CY 2007 with CY 2012.
iii. Pricing of ESRD-Related Drugs and Biologicals
As we stated above, we are proposing to price ESRD-related drugs
and biologicals to CY 2014 to allow for an accurate comparison between
utilization of those drugs and biologicals furnished in CY 2007 with
utilization in CY 2012. In order to price ESRD-related drugs and
biologicals based on CY 2014 prices, we started with CY 2011 prices as
established and published in the CY 2011 ESRD PPS final rule.
During the development of the ESRD PPS base rate, we included the
MAP amounts for ESRD-related drugs and biologicals that were, prior to
January 1, 2011, separately paid under Part B. For setting the CY 2011
ESRD PPS base rate, for Part B separately billable drugs, we used the
first two quarters of ASP+6 and then used the Producer Price Index
(PPI) to inflate the prices to CY 2011 (75 FR 49079). We also included
the MAP amounts for the ESRD-related oral-equivalent drugs and
biologicals that were, prior to January 1, 2011, separately paid under
Part D (75 FR 49080). For setting the CY 2011 ESRD PPS base rate for
these drugs, we used the growth rates for overall prescription drug
prices that were used in the National Health Expenditure Projections
(NHE) for updating prices for former Part D drugs to CY 2011 from CY
2007.
We propose to inflate the prices established in the CY 2011 ESRD
PPS final rule for ESRD-related drugs and biologicals and their oral
equivalents to CY 2014 by applying the ESRD bundled (ESRDB) market
basket, the productivity adjustment, and the wage index budget
neutrality adjustment factors. Because the base rate and the ESRDB
market basket account for ESRD-related drugs and biologicals, and we
have updated all components of the base rate annually using a market
basket minus productivity with wage index budget neutrality adjustment
factor, we believe that using these inflation factors are consistent
with how these services are paid under the ESRD PPS. The drug component
of the ESRDB market basket uses the PPI for prescription drugs as a
proxy for the growth in drug prices. We believe using the ESRDB market
basket to price drugs and biologicals for CY 2014 complies with the
requirement in section 1881(b)(14)(I) that the Secretary take into
account the changes in prices for drugs and biologicals reflected in
the ESRDB market basket percentage increase factor. The ESRDB market
basket minus productivity increase factors were 2.1 percent and 2.3
percent for CY 2012 and CY 2013, respectively. The proposed CY 2014
update is 2.5 percent. The wage index budget neutrality adjustment
factors for the same years are 1.001520, 1.000613, and a proposed
factor of 1.000411. Therefore, we propose to use a total growth update
factor of 7.3 percent (1.021*1.023*1.025*1.001520* 1.000613*1.000411 =
1.073) to inflate prices for ESRD-related drugs and biologicals from CY
2011 levels to CY 2014 levels. We solicit comments on the use of the
ESRDB market basket percentage increase factor to inflate prices for
drugs and biologicals to CY 2014 levels.
[[Page 40843]]
iv. Calculation of the Amount of the per Treatment Reduction
We applied the 2014 prices to the CY 2007 and CY 2012 drug and
biological utilization data to calculate aggregate amounts for each
year. For drugs and biologicals for which we have utilization data for
CY 2012, but that were not present on CY 2007 claims, we priced these
drugs using the ASP+6 percent price for 2012, which is an average of
the four quarter prices, and inflated it using the CY 2013 and the CY
2014 proposed ESRDB market basket, productivity, and wage index budget
neutrality adjustment factors. While most of these drugs had minimal
utilization, we note that Feraheme was the only significant exception.
Specifically, Feraheme was not available until January 2010 and once
the drug was available, the use of the drug rose to the top 12th drug
furnished to ESRD beneficiaries. Next, we divided each year's estimated
aggregate amount for drugs and biologicals by that year's count of
treatments furnished to Medicare beneficiaries to get an average
payment per treatment for the year. This resulted in a per treatment
amount for drugs and biologicals of $83.76 in 2007 and a per treatment
amount for drugs and biologicals of $51.42 in 2012. We then subtracted
the average payment per treatment for CY 2012 from the average amount
per treatment for CY 2007 to get a total of $32.34 ($83.76-$51.42 =
$32.34). We then reduced this amount by the standardization, the
outlier, and the 98 percent budget neutrality adjustments to get a
total of $29.52 ($32.34 x .9407 x .99 x .98 = $29.52). We would apply
these adjustments before reducing the base rate because the base rate
was reduced by these adjustments when it was first established, and the
reduction should be adjusted in the same way to make the two figures
comparable. We would then reduce the CY 2014 proposed base rate of
$246.47 by $29.52, resulting in the CY 2014 proposed base rate of
$216.95. A reduction of $29.52 from the proposed CY 2014 ESRD PPS base
rate results in a 12 percent reduction in Medicare payments. We solicit
comments on the proposed methodology for the reduction to the ESRD PPS
base rate to reflect the change in the utilization of ESRD-related
drugs and biologicals from CY 2007 to CY 2012.
While we propose to implement the full reduction in CY 2014, we
note that we are also concerned that this one-time reduction to the
ESRD PPS base rate could be a significant reduction to ESRD facilities
for the year and potentially impact beneficiary access to care.
Therefore, we are soliciting comments on a potential transition or
phase-in period of the 12 percent reduction and the number of years for
such transition or phase-in period.
v. Comparison of ASP Versus PPI
Section 1881(b)(14)(I) requires the Secretary to ``take into
account the most recently available data on average sales prices and
changes in prices for drugs and biologicals reflected in the ESRDB
market basket percentage increase factor'' in making the reduction to
the ESRD PPS base rate to reflect the change in utilization of ESRD-
related drugs and biologicals from CY 2007 to CY 2012. While we could
have chosen to inflate prices for drugs and biologicals to 2014 levels
with more recently available ASP data, we believe using a growth based
on the ESRDB market basket is more appropriate because it reflects what
Medicare is required to pay for the drugs and biologicals through the
ESRD PPS base rate. We performed an alternative analysis using prices
based on the first quarter 2013 ASP+6 percent prices and the National
Drug Code (NDC) prices published on the CMS Web site located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Outlier_Services.html that are used for outlier calculations, and the
PPI to project to CY 2014. The results are minimally different (a
difference of $29.40 versus $29.52), and we believe that the ESRDB
market basket approach is a more appropriate measure of how Medicare
pays for these drugs under the ESRD PPS.
We are soliciting comments on the potential use of ASP instead of
the ESRDB market basket to inflate drug prices to 2014 levels for
purposes of the drug utilization adjustment.
3. ESRD Bundled Market Basket
a. Overview and Background
In accordance with section 1881(b)(14)(F)(i) of the Act, as added
by section 153(b) of MIPPA and amended by section 3401(h) of the
Affordable Care Act, beginning in 2012, the ESRD payment amounts are
required to be annually increased by an ESRD market basket increase
factor that is reduced by the productivity adjustment described in
section 1886(b)(3)(B)(xi)(II) of the Act. The application of the
productivity adjustment described may result in the increase factor
being less than 0.0 for a year and may result in payment rates for a
year being less than the payment rates for the preceding year. The
statute also provides that the market basket increase factor should
reflect the changes over time in the prices of an appropriate mix of
goods and services used to furnish renal dialysis services.
b. Proposed Market Basket Update Increase Factor and Labor-Related
Share for ESRD Facilities for CY 2014
As required under section 1881(b)(14)(F)(i) of the Act, CMS
developed an all-inclusive ESRDB input price index (75 FR 49151 through
49162). Although ``market basket'' technically describes the mix of
goods and services used for ESRD treatment, this term is also commonly
used to denote the input price index (that is, cost categories, their
respective weights, and price proxies combined) derived from a market
basket. Accordingly, the term ``ESRDB market basket,'' as used in this
document, refers to the ESRDB input price index.
For this proposed rule, we propose to use the same methodology and
the CY 2008-based ESRDB market basket described in the CY 2011 ESRD PPS
final rule (75 FR 49151 through 49162) to compute the CY 2014 ESRDB
market basket increase factor and labor-related share based on the best
available data. Consistent with historical practice, we estimate the
ESRDB market basket update based on IHS Global Insight (IGI), Inc.'s
forecast using the most recently available data. IGI is a nationally
recognized economic and financial forecasting firm that contracts with
CMS to forecast the components of the market baskets.
Using this methodology and the IGI forecast for the first quarter
of 2013 of the CY 2008-based ESRDB market basket (with historical data
through the fourth quarter of 2012), and consistent with our historical
practice of estimating market basket increases based on the best
available data, the proposed CY 2014 ESRDB market basket increase
factor is 2.9 percent.
For the CY 2014 ESRD payment update, we propose to continue using a
labor-related share of 41.737 percent for the ESRD PPS payment, which
was finalized in the CY 2011 ESRD final rule (75 FR 49161).
c. Proposed Productivity Adjustment
Under section 1881(b)(14)(F)(i) of the Act, as amended by section
3401(h) of the Affordable Care Act, for CY 2012 and each subsequent
year, the ESRD market basket percentage increase factor shall be
reduced by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity
adjustment as equal to the 10-year moving average of changes in annual
economy-wide private nonfarm business
[[Page 40844]]
multifactor productivity (MFP) (as projected by the Secretary for the
10-year period ending with the applicable fiscal year, year, cost
reporting period, or other annual period) (the ``MFP adjustment''). The
Bureau of Labor Statistics (BLS) is the agency that publishes the
official measure of private nonfarm business MFP. Please see https://www.bls.gov/mfp to obtain the BLS historical published MFP data.
CMS notes that the proposed and final methodology for calculating
and applying the MFP adjustment to the ESRD payment update is similar
to the methodology used in other payment systems, as required by
section 3401 of the Affordable Care Act.
The projection of MFP is currently produced by IGI. The details
regarding the methodology for forecasting MFP and how it is applied to
the market basket were finalized in the CY 2012 ESRD PPS final rule (76
FR 70232 through 70234). Using this method and the IGI forecast for the
first quarter of 2013 of the 10-year moving average of MFP, the
proposed CY 2014 MFP factor is 0.4 percent.
d. Calculation of the ESRDB Market Basket Update, Adjusted for
Multifactor Productivity for CY 2014
Under section 1881(b)(14)(F) of the Act, beginning in CY 2012, ESRD
PPS payment amounts shall be annually increased by an ESRD market
basket percentage increase factor reduced by the productivity
adjustment. We are proposing to use the same methodology for
calculating the ESRDB market basket updates adjusted for MFP that was
finalized in the CY 2012 ESRD PPS final rule (76 FR 70234).
Thus, in accordance with section 1881(b)(14)(F)(i) of the Act, the
proposed ESRDB market basket percentage increase factor for CY 2014 is
based on the 1st quarter 2013 forecast of the CY 2008-based ESRDB
market basket, which is estimated to be 2.9 percent. This market basket
percentage is then reduced by the MFP adjustment (the 10-year moving
average of MFP for the period ending CY 2014) of 0.4 percent, which is
based on IGI's 1st quarter 2013 forecast. The resulting proposed MFP-
adjusted ESRDB market basket update for CY 2014 is equal to 2.5
percent, or 2.9 percent less 0.4 percentage point. If more recent data
is subsequently available (for example, a more recent estimate of the
market basket or MFP adjustment), we will use such data, if
appropriate, to determine the CY 2014 market basket update and MFP
adjustment in the CY 2014 ESRD PPS final rule.
4. The Proposed CY 2014 Wage Index
Section 1881(b)(14)(D)(iv)(II) of the Act provides that the ESRD
PPS may include a geographic wage index payment adjustment, such as the
index referred to in section 1881(b)(12)(D) of the Act. In the CY 2011
ESRD PPS final rule (75 FR 49117), we finalized the use of the Office
of Management and Budget's (OMB) Core-Based Statistical Areas (CBSAs)-
based geographic area designations to define urban and rural areas and
their corresponding wage index values. In the CY 2012 ESRD PPS final
rule (76 FR 70239) we finalized that, under the ESRD PPS, we will
continue to utilize the ESRD PPS wage index methodology, first
established under the basic case-mix adjusted composite rate payment
system, for updating the wage index values using the OMB's CBSA-based
geographic area designations to define urban and rural areas and
corresponding wage index values; the gradual reduction of the wage
index floor during the transition; and the policies for areas with no
hospital data. The CBSA-based geographic area designations were
originally described in OMB bulletin 03-04, issued June 6, 2003. This
bulletin, as well as subsequent bulletins, is available online at
https://www.whitehouse,gov/omb/bulletins.
OMB publishes bulletins regarding CBSA changes, including changes
to CBSA numbers and titles. In accordance with our established
methodology, we have historically adopted any CBSA changes that are
published in the OMB bulletin that corresponds with the IPPS hospital
wage index. For FY 2014, we use the FY 2013 pre-floor, pre-reclassified
hospital wage index to adjust the ESRD PPS payments. On February 28,
2013, OMB issued OMB Bulletin No. 13-01, which establishes revised
delineations of statistical areas based on OMB standards published in
the Federal Register on June 28, 2010 and 2010 Census Bureau data.
Because the FY 2013 pre-floor, pre-reclassified hospital wage index was
finalized prior to the issuance of this Bulletin, the FY 2013 pre-
floor, pre-reclassified hospital wage index does not reflect OMB's new
area delineations based on the 2010 Census and, thus, the FY 2014 ESRD
PPS wage index will not reflect the OMB changes. As stated in the FY
2014 IPPS/LTCH PPS proposed rule, CMS intends to propose changes to the
hospital wage index based on this OMB Bulletin in the FY 2015 IPPS/LTCH
PPS proposed rule (78 FR 27486 (May 10, 2013)). Therefore, we
anticipate that the OMB Bulletin changes will be reflected in the FY
2015 hospital wage index. Because we base the ESRD PPS wage index on
the hospital wage index from the prior year, we anticipate that the OMB
Bulletin changes would be reflected in the CY 2015 ESRD PPS wage index.
For CY 2014, we will continue to use the same methodology as
finalized in the CY 2011 ESRD PPS final rule (75 FR 49117), for
determining the wage indices for ESRD facilities in CY 2014.
Specifically, we propose to adjust wage indices for CY 2014 to account
for annually updated wage levels in areas in which ESRD facilities are
located. We propose to use the most recent, FY 2014 inpatient
prospective payment system (IPPS) pre-floor, pre-reclassified hospital
wage index. The ESRD PPS wage index values are calculated without
regard to geographic reclassifications authorized under section
1886(d)(8) and (d)(10) of the Act and utilize pre-floor hospital data
that are unadjusted for occupational mix. The proposed CY 2014 wage
index values for urban areas are listed in Addendum A (Wage Indices for
Urban Areas) and the proposed CY 2014 wage index values for rural areas
are listed in Addendum B (Wage Indices for Rural Areas). Addenda A and
B are located on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html.
In the CY 2011 ESRD PPS final rule (75 FR 49117), we finalized a
policy to use the labor-related share of 41.737 for the ESRD PPS
portion of the payment. For the CY 2014 ESRD PPS we are not proposing
any changes to the labor-related share of 41.737. Because all providers
that elected to participate in the transition are entering their fourth
year of the transition and will begin being paid 100 percent under the
ESRD PPS, the 53.711 labor-related share that was applied to the
composite rate portion of the blended payment is no longer applicable.
We discuss the methodology for the ESRD PPS labor-related share in our
CY 2011 ESRD PPS final rule (75 FR 49161), where we note that the
labor-related share is typically the sum of Wages and Salaries,
Benefits, Housekeeping and Operations, Professional Fees, Labor-related
Services, and a portion of the Capital-related Building and Equipment
expenses. For additional discussions on the labor-related share please
refer to section II.B.3.b. of this proposed rule.
[[Page 40845]]
a. Payment under the ESRD PPS for Facilities Located in Guam, American
Samoa, and the Northern Mariana Islands and Proposed Wage Index Value
for Guam
It came to our attention after the ESRD PPS was implemented that
ESRD facilities located in the United States Territories of Guam,
American Samoa and the Northern Mariana Islands (the Pacific Rim) have
been paid on the basis of reasonable costs and charges, rather than
under the ESRD PPS. Because section 1881(b)(14)(A)(i) of the Act
requires the Secretary to implement a payment system under which a
single payment is made to a renal dialysis facility for renal dialysis
services in lieu of any other payment for services furnished on or
after January 1, 2011, ESRD facilities located in the Pacific Rim must
be paid under the ESRD PPS and will be paid under this system beginning
for services furnished on or after January 1, 2014. In order to pay
these facilities under the ESRD PPS, we must identify an appropriate
wage index value for these areas as required under Sec. 413.231 of the
regulations. We propose to use the current value calculated under the
existing methodology, that is, the pre-floor, pre-reclassification,
hospital wage data that is unadjusted for occupational mix for the
island of Guam of 0.9611, which is displayed in Addendum B (Wage
Indices for Rural Areas). In addition, the most recent proposed FY 2014
IPPS pre-floor, pre-reclassified hospital wage data does not include
wage data for American Samoa and the Northern Mariana Islands.
Accordingly, we propose below to apply the wage index value for Guam to
facilities located in American Samoa and the Northern Mariana Islands.
b. Proposed Policies for Areas with No Wage Data
In the CY 2011 ESRD PPS final rule (75 FR 49117), we finalized the
use of the CBSA-based geographic area designations to define urban/
rural areas and corresponding wage index values for the ESRD PPS. In
that final rule (75 FR 49116 through 49117), we also discussed and
finalized the methodologies we use to calculate wage index values for
ESRD facilities that are located in urban and rural areas where there
is no hospital data. For urban areas with no hospital data, we compute
the average wage index value of all urban areas within the State and
use that value as the wage index. For rural areas with no hospital
data, we compute the wage index using the average wage index values
from all contiguous CBSAs to represent a reasonable proxy for that
rural area.
In the case of American Samoa and the Northern Mariana Islands, we
believe that Guam represents a reasonable proxy because the islands are
located within the Pacific Rim and share a common status as United
States Territories. In addition, the Northern Mariana Islands and
American Samoa are rural areas with no hospital data. Therefore, we
will use our established methodology to compute an appropriate wage
index using the average wage index values from contiguous CBSAs, to
represent a reasonable proxy. While we appreciate that the islands of
the Pacific Rim are not actually contiguous, we believe that same
principle applies here, and that Guam is a reasonable proxy for
American Samoa and the Northern Marianas. We note that if hospital data
becomes available for any of the islands of the Pacific Rim we will use
that data for the appropriate CBSA's instead of the proxy. As discussed
previously, the current wage index value using the existing methodology
for Guam is 0.9611. Therefore, for CY 2014, we propose to apply this
wage index value of 0.9611 to ESRD facilities located in America Samoa
and the Northern Mariana Islands, which we are including in Addendum B.
For CY 2014, the only urban area without wage index data is
Hinesville-Fort Stewart, GA. As we discussed in our CY 2013 ESRD PPS
(77 FR 67459), we will continue to use the statewide urban average
based on the average of all urban areas within the state for urban
areas without hospital data. For CY 2014 the wage index value for CBSA
11 (Georgia) is 0.7482 and this is included in Addendum A.
Accordingly, we propose to apply the statewide urban average wage index
value of 0.7582 to Hinesville-Fort Stewart, GA.
c. Proposed Reduction to the ESRD Wage Index Floor
A wage index floor value has been used in lieu of the calculated
wage index values below the floor in making payment for renal dialysis
services under the ESRD PPS. In the CY 2011 ESRD PPS final rule (75 FR
49116 through 49117), we finalized that we would continue to reduce the
wage index floor by 0.05 for each of the remaining years of the
transition. We further specified in the CY 2012 ESRD PPS (76 FR 70241)
that we finalized the 0.05 reduction to the wage index floor for CYs
2012 and 2013, resulting in a wage index floor of 0.550 and 0.500,
respectively.
Our intention has been to provide a wage index floor only through
the 4-year transition to 100 percent implementation of the ERSD PPS (75
FR 49116 through 49117; 76 FR 70240 through 70241). Most recently, in
the CY 2013 ESRD PPS final rule (77 FR 67459 through 67461), we
discussed the elimination of the wage index floor beginning in CY 2014,
noting that we would propose a new methodology in CY 2014 to address
wages in rural Puerto Rico because we would no longer be applying a
wage index floor. The CY 2014 wage index values for both urban and
rural Puerto Rico remain below the finalized CY 2013 ESRD PPS wage
index floor of 0.500 (77 FR 67459), however, and we believe that both
rural and urban facilities in Puerto Rico would benefit from continuing
the gradual reduction of the floor. We believe that continuing the wage
index floor for CY 2014 and CY 2015 will allow renal dialysis
facilities located in Puerto Rico the benefit afforded to other
geographical areas in the fifty states of a gradual and systematic
elimination of the wage index floor. Therefore, for CY 2014 and for CY
2015, we propose to continue to apply the wage index floor to areas
with wage indexes below the floor. For CY 2014, Puerto Rico is the only
area with a wage index value below the proposed floor; however, to the
extent that other geographical areas fall below the floor in CY 2015 or
beyond we believe they should have the benefit of a gradual reduction
in the floor as well. We will continue to review wage index values and
the appropriateness of a wage index floor in the future.
For CY 2014 and CY 2015, we also propose to continue our policy of
gradually reducing the wage index floor by 0.05 per year. Specifically,
we propose a wage index floor value of 0.45 for CY 2014 and a wage
index floor value of 0.40 for CY 2015. We believe that continuing our
policy of applying a wage index floor for an additional two years would
allow Puerto Rico to benefit from the anticipated and predictable phase
out of the wage index floor. While we would not expect to continue this
policy past CY 2015, we will review the appropriateness of a wage index
floor for CY 2016 at that time.
d. Proposed Wage Index Budget-Neutrality Adjustment
Section 1881(b)(14)(D)(iv)(II) of the Act gives us broad discretion
to implement payment adjustments to the ESRD PPS, including an
adjustment of the ESRD PPS by a geographic index. Section
1881(b)(14)(D)(iv)(II) specifically refers to section 1881(b)(12)(D) as
an example of such a geographic index, and in the CY 2011
[[Page 40846]]
ESRD PPS final rule, we finalized the use of the same wage index
methodology that we utilized under the basic case-mix adjusted
composite rate payment system (75 FR 49116). We had applied a wage
index budget-neutrality adjustment factor under the basic case-mix
adjusted composite payment system, and accordingly, in the CY 2012 ESRD
PPS final rule, we finalized a policy for CY 2012 and future years to
apply wage index budget-neutrality adjustment factors to the composite
rate portion of the ESRD PPS blended payments for facilities
participating in the transition as well as to the base rate for the
ESRD PPS portion of the blended payment and the full ESRD PPS for those
facilities that elected to receive 100 percent of their payment under
that system (76 FR 70241 and 70242). We also finalized the methodology
for computing the wage index budget-neutrality adjustment factors for
CY 2012 and subsequent years (76 FR 70242).
For CY 2014, we are not proposing any changes to the methodology,
but we note that we will no longer compute a budget neutrality
adjustment factor for the composite rate portion of the ESRD PPS
blended payment because all facilities will be paid 100 percent under
the ESRD PPS in CY 2014. For ease of reference, we explain the
methodology for computing the budget-neutrality adjustment factor here.
For the CY 2014 wage index budget-neutrality adjustment factor, we use
the fiscal year (FY) 2014 pre-floor, pre-reclassified, non-occupational
mix-adjusted hospital data to compute the wage index values, 2012
outpatient claims (paid and processed as of December 31, 2012), and
geographic location information for each facility, which may be found
through Dialysis Facility Compare. Dialysis Facility Compare (DFC) can
be found at the DFC Web page on the CMS Web site at https://www.medicare.gov/dialysisfacilitycompare/. The FY 2014 hospital wage
index data for each urban and rural locale by CBSA may also be accessed
on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/?redirect=/AcuteInpatientPPS/WIFN/list.asp. The wage index data are located in the
section entitled, ``FY 2014 Proposed Rule Occupational Mix Adjusted and
Unadjusted Average Hourly Wage and Pre-Reclassified Wage Index by
CBSA''.
We computed the proposed CY 2014 wage index budget-neutrality
adjustment factor using treatment counts from the 2012 claims and
facility-specific CY 2013 payment rates to estimate the total dollar
amount that each ESRD facility would have received in CY 2013. The
total of these payments became the target amount of expenditures for
all ESRD facilities for CY 2014. Next, we computed the estimated dollar
amount that would have been paid for the same ESRD facilities using the
proposed ESRD wage index for CY 2014. The total of these payments
becomes the new CY 2014 amount of wage-adjusted expenditures for all
ESRD facilities. The wage index budget-neutrality factor is calculated
as the target amount divided by the new CY 2014 amount. When we
multiplied the wage index budget-neutrality factor by the applicable CY
2014 estimated payments, aggregate payments to ESRD facilities would
remain budget-neutral when compared to the target amount of
expenditures. That is, the wage index budget-neutrality adjustment
factor ensures that wage index adjustments do not increase or decrease
aggregate Medicare payments with respect to changes in wage index
updates. Therefore, we are proposing a wage index budget-neutrality
adjustment factor of 1.000411, which would be computed in ESRD PPS base
rate payment methodology when making payment for renal dialysis
services in CY 2014.
5. Application of the International Classification of Diseases (ICD),
Tenth Revision, to the Comorbidity Payment Adjustment Codes
In the CY 2011 ESRD PPS final rule (75 FR 49094), we explained that
section 1881(b)(14)(D)(i) of the Act, as added by section 153(b) of
MIPPA, requires that the ESRD PPS include a payment adjustment based on
case-mix that may take into account, among other things, patient
comorbidities. Comorbidities are specific patient conditions that
coexist with the patient's principal diagnosis that necessitates
dialysis. The comorbidity payment adjustment recognizes the increased
costs associated with comorbidities and provides additional payment for
certain conditions that occur concurrently with the need for dialysis.
To develop the comorbidity payment adjustment, we used a stepwise
regression model to analyze comorbidity data and found that certain
comorbidities are predictors of variation in payments for ESRD
patients. Details on the development of the comorbidity categories
eligible for the comorbidity payment adjustment, including an
explanation of the stepwise regression model that we used to analyze
comorbidity data, is discussed in the CY 2011 ESRD PPS final rule (75
FR 49094 through 49108). We analyzed the comorbidity categories and
excluded those categories from the comorbidity payment adjustment that
met any of three exclusion criteria (75 FR 49095 through 49100): (1)
Inability to create accurate clinical definitions; (2) potential for
adverse incentives regarding care; and (3) potential for ESRD
facilities to directly influence the prevalence of the co-morbidity
either by altering dialysis care, changing diagnostic testing patterns,
or liberalizing the diagnostic criteria.
We finalized six comorbidity categories eligible for the
comorbidity payment adjustment, each with associated International
Classification of Disease, 9th Revision, Clinical Modification (ICD-9-
CM) diagnosis codes (75 FR 49100). Among these categories are three
acute, short-term diagnostic categories (pericarditis, bacterial
pneumonia, and gastrointestinal tract bleeding with hemorrhage) and
three chronic diagnostic categories (hereditary hemolytic anemia with
sickle cell anemia, myelodysplastic syndrome, and monoclonal
gammopathy). The comorbidity categories eligible for the adjustment and
their associated ICD-9-CM codes were published in the Appendix of the
CY 2011 ESRD PPS final rule as Table E: ICD-9-CM Codes Recognized for a
Comorbidity Payment Adjustment (75 FR 49211).
In the CY 2012 ESRD PPS final rule (76 FR 70252), we clarified that
the ICD-9-CM codes eligible for the comorbidity payment adjustment are
subject to the annual ICD-9-CM coding updates that occur in the
hospital inpatient PPS final rule and are effective October 1st of
every year. We explained that any updates to the ICD-9-CM codes that
affect the categories of comorbidities and the diagnoses within the
comorbidity categories that are eligible for the comorbidity payment
adjustment would be communicated to ESRD facilities through sub-
regulatory guidance. Accordingly, Change Request (CR) 7476, Transmittal
2255, entitled, ``Quarterly Update to the End-Stage Renal Disease
Prospective Payment System, was issued on July 15, 2011 to update the
ICD-9-CM codes eligible for the comorbidity payment adjustment in
accordance with the annual ICD-9-CM update effective October 1, 2011.
This CR can be found on the CMS Web site at the following link: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2255CP.pdf. There have not been updates to the ICD-9-CM codes eligible
for the comorbidity
[[Page 40847]]
payment adjustment since October 1, 2011.
Effective October 1, 2014, CMS will implement the 10th revision of
the ICD coding scheme--ICD-10-CM. Because the transition to ICD-10-CM
coding will occur during CY 2014, we discuss here the crosswalk from
ICD-9-CM to ICD-10-CM codes for the purpose of determining eligibility
for the comorbidity payment adjustment.
We crosswalked the ICD-9-CM codes that are eligible for the
comorbidity payment adjustment to ICD-10-CM codes using the General
Equivalence Mappings (GEM) tool, which is the authoritative source for
crosswalking developed by the National Center for Health Statistics and
CMS. The crosswalk from ICD-9-CM to ICD-10-CM diagnosis codes resulted
in three scenarios: One ICD-9-CM code could crosswalk to one ICD-10-CM
code; one ICD-9-CM code crosswalked to multiple ICD-10-CM codes; or
multiple ICD-9-CM crosswalked to one ICD-10-CM code. We applied the
three exclusion criteria listed above to each of the ICD-10-CM codes to
which the ICD-9-CM codes crosswalked.
In our clinical evaluation, we found the ICD-9-CM codes generally
crosswalked to one ICD-10-CM code that codes for the same diagnosis,
has the same code descriptor, and does not meet any of our exclusion
criteria. Accordingly, with the exceptions noted below, we propose that
ICD-10-CM codes will be eligible for the comorbidity payment adjustment
where they crosswalk from ICD-9-CM codes that are eligible for the
comorbidity payment adjustment. There are, however, two instances where
ICD-9-CM codes crosswalk to ICD-10-CM codes that we believe meet one or
more of the exclusion criteria described above, and we propose to
exclude these codes from eligibility for the comorbidity payment
adjustment.
a. One ICD-9-CM Code Crosswalks to One ICD-10-CM Code
Table 1 lists all the instances in which one ICD-9-CM code
crosswalks to one ICD-10-CM code. We propose that all of those ICD-10-
CM codes will be subject to the comorbidity payment adjustment with the
exception of K52.81 Eosinophilic gastritis or gastroenteritis.
Currently, 535.71 Eosinophilic gastritis with hemorrhage is one of 40
ICD-9-CM diagnosis codes under the acute comorbidity category of
Gastrointestinal (GI) Bleeding. The descriptor of K52.81, the ICD-10-CM
code to which this ICD-9-CM code crosswalks, does not include the word
``hemorrhage.'' In the CY 2011 ESRD PPS final rule (75 FR 49097), we
specifically limited the GI bleeding category for the comorbidity
payment adjustment to GI bleed with hemorrhage because we believed that
the gastrointestinal tract bleeding category met our first exclusion
criterion--inability to create accurate clinical definitions--because
it was overly broad. We also believed that use of this diagnosis
category could lead to gaming consistent with the second and third
exclusion criteria listed above. For these reasons, we limited the
gastrointestinal tract bleeding diagnosis category to gastrointestinal
tract bleeding with hemorrhage, which we believe creates accurate
clinical definitions and mitigates the potential for adverse incentives
in ESRD care. Accordingly, we propose to exclude ICD-10-CM code K52.81
Eosinophilic gastritis or gastroenteritis from eligibility for the
comorbidity payment adjustment because the code descriptor does not
indicate the diagnosis of a hemorrhage. We propose that all of the
other ICD-10-CM codes listed in the Table 1 below will be eligible for
the comorbidity payment adjustment.
Table 1--One ICD-9-CM Code Crosswalks to One ICD-10-CM Code
----------------------------------------------------------------------------------------------------------------
ICD-9 Descriptor ICD-10 Descriptor
----------------------------------------------------------------------------------------------------------------
Gastrointestinal Bleeding
----------------------------------------------------------------------------------------------------------------
530.21....................... Ulcer of esophagus with K22.11....................... Ulcer of esophagus with
bleeding. bleeding
535.71....................... Eosinophilic gastritis, K52.81....................... Eosinophilic gastritis
with hemorrhage. or gastroenteritis
537.83....................... Angiodysplasia of K31.811...................... Angiodysplasia of
stomach and duodenum stomach and duodenum
with hemorrhage. with bleeding
569.85....................... Angiodysplasia of K55.21....................... Angiodysplasia of colon
intestine with with hemorrhage
hemorrhage.
----------------------------------------------------------------------------------------------------------------
Bacterial Pneumonia
----------------------------------------------------------------------------------------------------------------
003.22....................... Salmonella pneumonia.... A02.22....................... Salmonella pneumonia
482.0........................ Pneumonia due to J15.0........................ Pneumonia due to
Klebsiella pneumonia. Klebsiella pneumoniae
482.1........................ Pneumonia due to J15.1........................ Pneumonia due to
Pseudomonas. Pseudomonas
482.2........................ Pneumonia due to J14.......................... Pneumonia due to
Hemophilus influenzae Hemophilus influenzae
[H. influenzae].
482.32....................... Pneumonia due to J15.3........................ Pneumonia due to
Streptococcus, group B. streptococcus, group B
482.40....................... Pneumonia due to J15.20....................... Pneumonia due to
Staphylococcus, staphylococcus,
unspecified. unspecified
482.41....................... Methicillin susceptible J15.211...................... Pneumonia due to
pneumonia due to Methicillin susceptible
Staphylococcus aureus. Staphylococcus aureus
482.42....................... Methicillin resistant J15.212...................... Pneumonia due to
pneumonia due to Methicillin resistant
Staphylococcus aureus. Staphylococcus aureus
482.49....................... Other Staphylococcus J15.29....................... Pneumonia due to other
pneumonia. staphylococcus
482.82....................... Pneumonia due to J15.5........................ Pneumonia due to
escherichia coli [E. Escherichia coli
coli].
482.83....................... Pneumonia due to other J15.6........................ Pneumonia due to other
gram-negative bacteria. aerobic Gram-negative
bacteria
482.84....................... Pneumonia due to A48.1........................ Legionnaires' disease
Legionnaires' disease.
507.0........................ Pneumonitis due to J69.0........................ Pneumonitis due to
inhalation of food or inhalation of food and
vomitus. vomit
507.8........................ Pneumonitis due to other J69.8........................ Pneumonitis due to
solids and liquids. inhalation of other
solids and liquids
510.0........................ Empyema with fistula.... J86.0........................ Pyothorax with fistula
510.9........................ Empyema without mention J86.9........................ Pyothorax without
of fistula. fistula
----------------------------------------------------------------------------------------------------------------
[[Page 40848]]
Pericarditis
----------------------------------------------------------------------------------------------------------------
420.91....................... Acute idiopathic I30.0........................ Acute nonspecific
pericarditis. idiopathic pericarditis
----------------------------------------------------------------------------------------------------------------
Hereditary Hemolytic and Sickle Cell Anemia
----------------------------------------------------------------------------------------------------------------
282.0........................ Hereditary spherocytosis D58.0........................ Hereditary spherocytosis
282.1........................ Hereditary D58.1........................ Hereditary
elliptocytosis. elliptocytosis
282.41....................... Sickle-cell thalassemia D57.40....................... Sickle-cell thalassemia
without crisis. without crisis
282.43....................... Alpha thalassemia....... D56.0........................ Alpha thalassemia
282.44....................... Beta thalassemia........ D56.1........................ Beta thalassemia
282.45....................... Delta-beta thalassemia.. D56.2........................ Delta-beta thalassemia
282.46....................... Thalassemia minor....... D56.3........................ Thalassemia minor
282.47....................... Hemoglobin E-beta D56.5........................ Hemoglobin E-beta
thalassemia. thalassemia
282.49....................... Other thalassemia....... D56.8........................ Other thalassemias
282.61....................... Hb-SS disease without D57.1........................ Sickle-cell disease
crisis. without crisis
282.63....................... Sickle-cell/Hb-C disease D57.20....................... Sickle-cell/Hb-C disease
without crisis. without crisis
282.68....................... Other sickle-cell D57.80....................... Other sickle-cell
disease without crisis. disorders without
crisis
----------------------------------------------------------------------------------------------------------------
Myelodysplastic Syndrome
----------------------------------------------------------------------------------------------------------------
238.7........................ Essential D47.3........................ Essential (hemorrhagic)
thrombocythemia. thrombocythemia
238.73....................... High grade D46.22....................... Refractory anemia with
myelodysplastic excess of blasts 2
syndrome lesions.
238.74....................... Myelodysplastic syndrome D46.C........................ Myelodysplastic syndrome
with 5q deletion. with isolated del(5q)
chromosomal abnormality
238.76....................... Myelofibrosis with D47.1........................ Chronic
myeloid metaplasia. myeloproliferative
disease
----------------------------------------------------------------------------------------------------------------
b. One ICD-9-CM Code Crosswalks to Multiple ICD-10-CM Codes
Table 2 lists all of the instances in which one ICD-9-CM code
crosswalks to multiple ICD-10-CM codes. In those instances, we propose
that all the crosswalked ICD-10-CM codes will be subject to the
comorbidity payment adjustment, with the exception of D89.2
Hypergammaglobulinemia, unspecified. ICD-9-CM code 273.1 Monoclonal
paraproteinemia is the only ICD-9-CM code eligible for the comorbidity
payment adjustment under the chronic comorbidity category of Monoclonal
gammopathy. ICD-9-CM code 273.1 Monoclonal paraproteinemia crosswalks
to two ICD-10-CM codes: D47.2 Monoclonal gammopathy and D89.2
Hypergammaglobulinemia, unspecified. We analyzed both of these ICD-10-
CM codes and determined that D47.2 Monoclonal gammopathy should be
eligible for the comorbidity payment adjustment because, like ICD-9-CM
code 273.1 Monoclonal paraproteinemia, it indicates that there is an
excessive amount of a single monoclonal gammaglobulin. When we analyzed
the comorbidity category for the CY 2011 ESRD PPS final rule, single
monoclonal gammaglobulin was shown to have an association with higher
erythropoiesis stimulating agent (ESA) usage, thereby resulting in
higher costs to dialysis facilities. After clinical evaluation of D89.2
Hypergammaglobulinemia, unspecified, however, we determined that this
ICD-10-CM code should not be eligible for the comorbidity payment
adjustment because D89.2 Hypergammaglobulinemia, unspecified indicates
only that 1 or more immunoglobulins are elevated, but does not identify
which immunoglobulin(s) are elevated. We believe that the lack of
specificity of this particular code results in an inability to create
an accurate clinical definition, which is the first of the three
exclusion criteria. Accordingly, we propose that D89.2
Hypergammaglobulinemia, unspecified will not be eligible for the
comorbidity payment adjustment. We propose that all of the other ICD-
10-CM codes listed in Table 2 below will be eligible for the
comorbidity payment adjustment.
Table 2--One ICD-9-CM Code Crosswalks to Multiple ICD-10-CM Codes
----------------------------------------------------------------------------------------------------------------
ICD-9 Descriptor ICD-10 Descriptor
----------------------------------------------------------------------------------------------------------------
Gastrointestinal Bleeding
----------------------------------------------------------------------------------------------------------------
562.......................... Diverticulosis of small K57.11....................... Diverticulosis of small
intestine with intestine without
hemorrhage. perforation or abscess
with bleeding.
K57.51....................... Diverticulosis of both
small and large
intestine without
perforation or abscess
with bleeding.
562.03....................... Diverticulitis of small K57.01....................... Diverticulitis of small
intestine with intestine with
hemorrhage. perforation and abscess
with bleeding.
K57.13....................... Diverticulitis of small
intestine without
perforation or abscess
with bleeding.
K57.41....................... Diverticulitis of both
small and large
intestine with
perforation and abscess
with bleeding.
K57.53....................... Diverticulitis of both
small and large
intestine without
perforation or abscess
with bleeding.
562.12....................... Diverticulosis of colon K57.31....................... Diverticulosis of large
with hemorrhage. intestine without
perforation or abscess
with bleeding.
[[Page 40849]]
K57.91....................... Diverticulosis of
intestine, part
unspecified, without
perforation or abscess
with bleeding.
K57.51....................... Diverticulosis of both
small and large
intestine without
perforation or abscess
with bleeding.
562.13....................... Diverticulitis of colon K57.21....................... Diverticulitis of large
with hemorrhage. intestine with
perforation and abscess
with bleeding.
K57.33....................... Diverticulitis of large
intestine without
perforation or abscess
with bleeding.
K57.41....................... Diverticulitis of both
small and large
intestine with
perforation and abscess
with bleeding.
K57.53....................... Diverticulitis of both
small and large
intestine without
perforation or abscess
with bleeding.
----------------------------------------------------------------------------------------------------------------
Bacterial Pneumonia
----------------------------------------------------------------------------------------------------------------
513.0........................ Abscess of lung......... J85.0........................ Gangrene and necrosis of
lung.
J85.1........................ Abscess of lung with
pneumonia.
J85.2........................ Abscess of lung without
pneumonia.
----------------------------------------------------------------------------------------------------------------
Pericarditis
----------------------------------------------------------------------------------------------------------------
420.0........................ Acute pericarditis in A18.84....................... Tuberculosis of heart.
diseases classified
elsewhere.
I32.......................... Pericarditis in diseases
classified elsewhere.
M32.12....................... Pericarditis in systemic
lupus erythematosus.
420.90....................... Acute pericarditis, I30.1........................ Infective pericarditis.
unspecified.
I30.9........................ Acute pericarditis,
unspecified.
420.99....................... Other acute pericarditis I30.8........................ Other forms of acute
pericarditis.
I30.9........................ Acute pericarditis,
unspecified.
----------------------------------------------------------------------------------------------------------------
Hereditary Hemolytic and sickle cell anemia
----------------------------------------------------------------------------------------------------------------
282.2........................ Anemias due to disorders D55.0........................ Anemia due to glucose-6-
of glutathione phosphate dehydrogenase
metabolism. [G6PD] deficiency.
D55.1........................ Anemia due to other
disorders of
glutathione metabolism.
282.3........................ Other hemolytic anemias D55.2........................ Anemia due to disorders
due to enzyme of glycolytic enzymes.
deficiency.
D55.3........................ Anemia due to disorders
of nucleotide
metabolism.
D55.8........................ Other anemias due to
enzyme disorders.
D55.9........................ Anemia due to enzyme
disorder, unspecified.
282.42....................... Sickle-cell thalassemia D57.411...................... Sickle-cell thalassemia
with crisis. with acute chest
syndrome.
D57.412...................... Sickle-cell thalassemia
with splenic
sequestration.
D57.419...................... Sickle-cell thalassemia
with crisis,
unspecified.
282.62....................... Hb-SS disease with D57.00....................... Hb-SS disease with
crisis. crisis, unspecified.
D57.01....................... Hb-SS disease with acute
chest syndrome.
D57.02....................... Hb-SS disease with
splenic sequestration.
282.64....................... Sickle-cell/Hb-C disease D57.211...................... Sickle-cell/Hb-C disease
with crisis. with acute chest
syndrome.
D57.212...................... Sickle-cell/Hb-C disease
with splenic
sequestration.
D57.219...................... Sickle-cell/Hb-C disease
with crisis,
unspecified.
282.69....................... Other sickle-cell D57.811...................... Other sickle-cell
disease with crisis. disorders with acute
chest syndrome.
D57.812...................... Other sickle-cell
disorders with splenic
sequestration.
D57.819...................... Other sickle-cell
disorders with crisis,
unspecified.
----------------------------------------------------------------------------------------------------------------
Monoclonal Gammopathy
----------------------------------------------------------------------------------------------------------------
273.1........................ Monoclonal D47.2........................ Monoclonal gammopathy.
paraproteinemia.
D89.2........................ Hypergammaglobulinemia,
unspecified.
----------------------------------------------------------------------------------------------------------------
Myelodysplastic Syndrome
----------------------------------------------------------------------------------------------------------------
238.72....................... Low grade D46.0........................ Refractory anemia
myelodysplastic without ring
syndrome lesions. sideroblasts, so
stated.
D46.1........................ Refractory anemia with
ring sideroblasts.
D46.20....................... Refractory anemia with
excess of blasts,
unspecified.
D46.21....................... Refractory anemia with
excess of blasts 1.
D46.4........................ Refractory anemia,
unspecified.
D46.A........................ Refractory cytopenia
with multilineage
dysplasia.
D46.B........................ Refractory cytopenia
with multilineage
dysplasia and ring
sideroblasts.
238.75....................... Myelodysplastic D46.9........................ Myelodysplastic
syndrome, unspecified. syndrome, unspecified.
[[Page 40850]]
D46.Z........................ Other myelodysplastic
syndromes.
----------------------------------------------------------------------------------------------------------------
c. Multiple ICD-9-CM Codes Crosswalk to One ICD-10-CM Code
Table 3 displays the crosswalk where multiple ICD-9-CM codes
crosswalk to one ICD-10-CM code. For the reasons explained above, we
propose that all of the crosswalked ICD-10-CM codes listed below will
be eligible for the comorbidity payment adjustment.
Table 3--Multiple ICD-9-CM Codes Crosswalk to One ICD-10-CM Code
----------------------------------------------------------------------------------------------------------------
ICD-9 Descriptor ICD-10 Descriptor
----------------------------------------------------------------------------------------------------------------
Gastrointestinal Bleeding
----------------------------------------------------------------------------------------------------------------
533.20....................... Acute peptic ulcer of K27.2........................ Acute peptic ulcer, site
unspecified site with unspecified, with both
hemorrhage and hemorrhage and
perforation, without perforation.
mention of obstruction.
533.21....................... Acute peptic ulcer of
unspecified site with
hemorrhage and
perforation, with
obstruction.
533.40....................... Chronic or unspecified K27.4........................ Chronic or unspecified
peptic ulcer of peptic ulcer, site
unspecified site with unspecified, with
hemorrhage, without hemorrhage.
mention of obstruction.
533.41....................... Chronic or unspecified
peptic ulcer of
unspecified site with
hemorrhage, with
obstruction.
533.60....................... Chronic or unspecified K27.6........................ Chronic or unspecified
peptic ulcer of peptic ulcer, site
unspecified site with unspecified, with both
hemorrhage and hemorrhage and
perforation, without perforation.
mention of obstruction.
533.61....................... Chronic or unspecified
peptic ulcer of
unspecified site with
hemorrhage and
perforation, with
obstruction.
534.00....................... Acute gastrojejunal K28.0........................ Acute gastrojejunal
ulcer with hemorrhage, ulcer with hemorrhage.
without mention of
obstruction.
534.01....................... Acute gastrojejunal
ulcer, with hemorrhage,
with obstruction.
534.20....................... Acute gastrojejunal K28.2........................ Acute gastrojejunal
ulcer with hemorrhage ulcer with both
and perforation, hemorrhage and
without mention of perforation.
obstruction.
534.21....................... Acute gastrojejunal
ulcer with hemorrhage
and perforation, with
obstruction.
534.40....................... Chronic or unspecified K28.4........................ Chronic or unspecified
gastrojejunal ulcer gastrojejunal ulcer
with hemorrhage, with hemorrhage.
without mention of
obstruction.
534.41....................... Chronic or unspecified
gastrojejunal ulcer,
with hemorrhage, with
obstruction.
534.60....................... Chronic or unspecified K28.6........................ Chronic or unspecified
gastrojejunal ulcer gastrojejunal ulcer
with hemorrhage and with both hemorrhage
perforation, without and perforation.
mention of obstruction.
534.61....................... Chronic or unspecified
gastrojejunal ulcer
with hemorrhage and
perforation, with
obstruction.
----------------------------------------------------------------------------------------------------------------
Bacterial Pneumonia
----------------------------------------------------------------------------------------------------------------
482.30....................... Pneumonia due to J15.4........................ Pneumonia due to other
Streptococcus, streptococci.
unspecified.
482.31....................... Pneumonia due to
Streptococcus, group A.
482.39....................... Pneumonia due to other
Streptococcus.
482.81....................... Pneumonia due to J15.8........................ Pneumonia due to other
anaerobes. specified bacteria.
482.89....................... Pneumonia due to other
specified bacteria.
----------------------------------------------------------------------------------------------------------------
In summary, based on our clinical evaluation of the ICD-10-CM codes
to which the eligible ICD-9-CM codes crosswalk, we propose that both
D89.2 Hypergammaglobulinemia, unspecified and K52.81 Eosinophilic
gastritis or gastroenteritis would not be eligible for the comorbidity
payment adjustment. We propose that all other ICD-10-CM codes to which
eligible ICD-9-CM codes crosswalk that are listed in the Tables above
will be eligible for the comorbidity payment adjustment effective
October 1, 2014. We are soliciting comments on the ICD-10-CM codes that
we propose to exclude and those we propose will be eligible for the
comorbidity payment adjustment.
6. Proposed Revisions to the Outlier Policy
Section 1881(b)(14)(D)(ii) of the Act requires that the ESRD PPS
include a payment adjustment for high cost outliers due to unusual
variations in the type or amount of medically necessary care, including
variability in the amount of erythropoiesis stimulating agents (ESAs)
necessary for anemia management. Our regulations at 42 CFR
[[Page 40851]]
Sec. 413.237(a)(1) provide that ESRD outlier services are the
following items and services that are included in the ESRD PPS bundle:
(i) ESRD-related drugs and biologicals that were or would have been,
prior to January 1, 2011, separately billable under Medicare Part B;
(ii) ESRD-related laboratory tests that were or would have been, prior
to January 1, 2011, separately billable under Medicare Part B; (iii)
medical/surgical supplies, including syringes, used to administer ESRD-
related drugs, that were or would have been, prior to January 1, 2011,
separately billable under Medicare Part B; and (iv) renal dialysis
service drugs that were or would have been, prior to January 1, 2011,
covered under Medicare Part D, excluding ESRD-related oral-only drugs.
In the CY 2011 ESRD PPS final rule (75 FR 49142), we stated that
for purposes of determining whether an ESRD facility would be eligible
for an outlier payment, it would be necessary for the facility to
identify the actual ESRD outlier services furnished to the patient by
line item on the monthly claim. The ESRD-related drugs, laboratory
tests, and medical/surgical supplies that we would recognize as outlier
services were specified in Attachment 3 of Change Request 7064,
Transmittal 2033 issued August 20, 2010, rescinded and replaced by
Transmittal 2094, dated November 17, 2010. With respect to the outlier
policy, Transmittal 2094 identified additional drugs and laboratory
tests that may be eligible for ESRD outlier payment. Transmittal 2094
was rescinded and replaced by Transmittal 2134, dated January 14, 2011,
which was issued to correct the subject on the Transmittal page and
made no other changes.
In the CY 2012 ESRD PPS final rule (76 FR 70246), we eliminated the
issuance of a specific list of eligible outlier service drugs which
were or would have been separately billable under Medicare Part B prior
to January 1, 2011. However, we use separate guidance to continue to
identify renal dialysis service drugs which were or would have been
covered under Part D for outlier eligibility purposes in order to
provide unit prices for calculating imputed outlier services. We also
can identify, through our monitoring efforts, items and services that
are incorrectly being identified as eligible outlier services in the
claims data. Any updates to the list of renal dialysis items and
services that qualify as outlier services are made through
administrative issuances, if necessary.
Our regulations at 42 CFR Sec. 413.237(a)(2) through (a)(6), (b),
and (c) specify the methodology used to calculate outlier payments. An
ESRD facility is eligible for an outlier payment if its actual or
imputed Medicare Allowable Payment (MAP) amount per treatment for ESRD
outlier services exceeds a threshold. The MAP amount represents the
average incurred amount per treatment for services that were or would
have been considered separately billable services prior to January 1,
2011. The threshold is equal to the ESRD facility's predicted ESRD
outlier services MAP amount per treatment (which is case-mix adjusted)
plus the fixed dollar loss amount. In accordance with Sec. 413.237(c)
of the regulations, facilities are paid 80 percent of the per treatment
amount by which the imputed MAP amount for outlier services (that is,
the actual incurred amount) exceeds this threshold. ESRD facilities are
eligible to receive outlier payments for treating both adult and
pediatric dialysis patients.
In the CY 2011 ESRD PPS final rule, using 2007 data, we established
the outlier percentage at 1.0 percent of total payments (75 FR 49142
through 49143). We also established the fixed dollar loss amounts that
are added to the predicted outlier services MAP amounts. The outlier
services MAP amounts and fixed dollar loss amounts are different for
adult and pediatric patients due to differences in the utilization of
separately billable services among adult and pediatric patients (75 FR
49140).
As we explained in the CY 2011 ESRD PPS final rule (75 FR 49138 and
49139), the predicted outlier services MAP amounts for a patient are
determined by multiplying the adjusted average outlier services MAP
amount by the product of the patient-specific case-mix adjusters
applicable using the outlier services payment multipliers developed
from the regression analysis to compute the payment adjustments. The
average outlier services MAP amount per treatment for CY 2011 was based
on payment amounts reported on 2007 claims and adjusted to reflect
projected prices for 2011. For CY 2012, the outlier services MAP
amounts and fixed dollar loss amounts were based on 2010 data (76 FR
70250). Thus, for CYs 2011 and 2012, the MAP and fixed dollar loss
amounts were computed based on pre-ESRD PPS claims data and
utilization. For CY 2013, the outlier services MAP amounts and fixed
dollar loss amounts were based on 2011 data (77 FR 67464). Therefore,
the outlier thresholds for CY 2013 were based on utilization of ESRD-
related items and services furnished under the ESRD PPS. Because of the
lower utilization of epoetin and other outlier services in CY 2011, we
lowered the MAP amounts and fixed dollar loss amounts for both adult
and pediatric patients for CY 2013 to allow for an increase in payments
for ESRD beneficiaries requiring higher resources.
a. Impact of Proposed Changes to the Outlier Policy
For CY 2014, we are not proposing any changes to the methodology
used to compute the MAP or fixed dollar loss amounts. Rather, in this
proposed rule, we are updating the outlier services MAP amounts and
fixed dollar loss amounts to reflect the utilization of outlier
services reported on the 2012 claims using the December 2012 claims
file. Accordingly, for CY 2014, the MAP and fixed dollar loss amounts
are based on the ESRD PPS claims and utilization. The impact of this
update is shown in Table 4, which compares the outlier services MAP
amounts and fixed dollar loss amounts used for the outlier policy in CY
2013 with the updated estimates for this proposed rule. The estimates
for the proposed outlier CY 2014 outlier policy, which are included in
Column II of Table 4, were inflation-adjusted to reflect projected 2014
prices for outlier services.
Table 4--Outlier Policy: Impact of Using Updated Data To Define the Outlier Policy
----------------------------------------------------------------------------------------------------------------
Column I Final outlier policy Column II Proposed outlier
for CY2013 (based on 2011 data policy for CY2014 (based on
price inflated to 2013) * 2012 data price inflated to
-------------------------------- 2014) *
-------------------------------
Age <18 Age >= 18 Age <18 Age >= 18
----------------------------------------------------------------------------------------------------------------
Average outlier services MAP amount per $38.65 $61.38 $38.65 $52.45
treatment \1\..................................
Adjustments
[[Page 40852]]
Standardization for outlier services \2\.... 1.0927 0.9878 1.0960 0.9893
MIPPA reduction............................. 0.98 0.98 0.98 0.98
Adjusted average outlier services MAP amount $41.39 $59.42 $41.51 $50.85
\3\........................................
Fixed dollar loss amount that is added to the $47.32 $110.22 $54.23 $94.26
predicted MAP to determine the outlier
threshold \4\..................................
Patient months qualifying for outlier payment... 7.6% 5.1% 6.2% 5.1%
----------------------------------------------------------------------------------------------------------------
* The outlier services MAP amounts and fixed dollar loss amounts were inflation adjusted to reflect updated
prices for outlier services (that is, 2013 prices in Column I and projected 2014 prices in Column II).
\1\ Excludes patients for whom not all data were available to calculate projected payments under an expanded
bundle. The outlier services MAP amounts are based on 2012 data. The medically unbelievable edits of 400,000
units for EPO and 1,200 mcg for Aranesp that are in place under the ESA claims monitoring policy were applied.
\2\ Applied to the average outlier MAP per treatment. Standardization for outlier services is based on existing
case mix adjusters for adult and pediatric patient groups.
\3\ This is the amount to which the separately billable (SB) payment multipliers are applied to calculate the
predicted outlier services MAP for each patient.
\4\ The fixed dollar loss amounts were calculated using 2012 data to yield total outlier payments that represent
1% of total projected payments for the ESRD PPS.
As seen in Table 4, the estimated fixed dollar loss amount that
determines the 2014 outlier threshold amount for adults (Column II) is
lower than that used for the 2013 outlier policy (Column I). The
estimated fixed dollar loss amount that determines the 2014 outlier
threshold amount for pediatric patients (Column II) is higher than that
used for the 2013 outlier policy (Column I). The main reason for the
reduction for adult patients is that the lower utilization of epoetin
and other outlier services continued to decline during the second year
of the PPS. This can be seen by comparing the outlier service MAP
amount per treatment for adult patients in Column I ($61.38, which is
based on 2011 data) with that amount in Column II ($52.45, which is
based on 2012 data).
For pediatric patients, there was no change in the overall average
outlier service MAP amount between 2011 and 2012 ($38.65 per treatment
in both Columns I and II). In addition, there was a greater tendency in
2012 for a relatively small percentage of pediatric patients to account
for a disproportionate share of the total outlier service MAP amounts.
The one percent target for outlier payments is therefore expected to be
achieved based on a smaller percentage of pediatric outlier cases using
2012 data compared to 2011 data (6.2 percent of pediatric patient
months are expected to qualify for outlier payments rather than 7.6
percent). These patterns led to the estimated fixed dollar loss amount
for pediatric patients being higher for the outlier policy for CY 2014
compared to the outlier policy for CY 2013. Generally, there is a
relatively higher likelihood for pediatric patients that the outlier
threshold may be adjusted to reflect changes in the distribution of
outlier service MAP amounts. This is due to the much smaller overall
number of pediatric patients compared to adult patients, and therefore
to the fact that the outlier threshold for pediatric patients is
calculated based on data for a much smaller number of pediatric
patients compared to adult patients.
We propose to update the fixed dollar loss amounts that are added
to the predicted MAP amounts per treatment to determine the outlier
thresholds for CY 2014 from $110.22 to $94.26 for adult patients and
from $47.32 to $54.23 for pediatric patients compared with CY 2013
amounts. We estimate that the percentage of patient months qualifying
for outlier payments under the current policy will be 5.1 percent and
6.2 percent for adult and pediatric patients, respectively, based on
the 2012 data. The pediatric outlier MAP and fixed dollar loss amounts
continue to be lower for pediatric patients than adults due to the
continued lower use of outlier services (primarily reflecting lower use
of epoetin and other injectable drugs).
b. Outlier Policy Percentage
42 CFR 413.220(b)(4) stipulates that the per treatment base rate is
reduced by 1 percent to account for the proportion of the estimated
total payments under the ESRD PPS that are outlier payments. Based on
the 2012 claims, outlier payments represented approximately 0.2 percent
of total payments, again falling short of the 1 percent target due to
the continuing decline in use of outlier services. Use of 2012 data to
recalibrate the thresholds, which reflect lower utilization of EPO and
other outlier services, is expected to result in aggregate outlier
payments close to the 1 percent target in CY 2014. We believe the
proposed update to the outlier MAP and fixed dollar loss amounts for CY
2014 will increase payments for ESRD beneficiaries requiring higher
resource utilization and come closer to meeting our 1 percent outlier
policy.
We note that recalibration of the fixed dollar loss amounts in this
proposed rule for CY 2014 outlier payments results in no change in
payments to ESRD facilities for beneficiaries with renal dialysis items
and services that are not eligible for outlier payments, but increases
payments to providers for beneficiaries with renal dialysis items and
services that are eligible for outlier payments. Therefore, beneficiary
co-insurance obligations would also increase for renal dialysis
services eligible for outlier payments.
C. Discussion of Self-Dialysis and Home Dialysis Training Add-on
Adjustment and Request for Public Comments
a. Medicare Policy for Self-Dialysis Training, Home Dialysis Training,
and Retraining
The existing Medicare policy for furnishing self-dialysis training,
home dialysis training, and retraining was finalized in our CY 2011
ESRD PPS final rule (75 FR 49062 through 49064) and further discussed
in the Medicare Benefits Policy Manual, (Publication 100-02, Chapter
11). Self-dialysis or home dialysis can only be performed
[[Page 40853]]
after an ESRD patient has completed an appropriate course of training.
The scope of training services that a certified ESRD facility must
furnish to ESRD patients as a condition of coverage is described at 42
CFR 494.100(a). For instance, 42 CFR 494.100(a)(2) states that the
training must be conducted by a registered nurse. For additional
information on the requirements for ESRD facilities in furnishing
dialysis training, see 42 CFR Part 494, and additional information
regarding home dialysis training certification, see the State
Operations Manual, which may be viewed on the Medicare Web site at the
following link: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Dialysis.html.
42 CFR 494.70 (Condition: Patients' rights) requires that
facilities inform patients (or their representatives) of their rights
and responsibilities when they begin their treatment and protect and
provide for the exercise of those rights. Our regulation at 42 CFR
Sec. 494.70(7) requires a facility to inform patients about all
treatment modalities' and settings, including but not limited to
transplantation, home dialysis modalities, and in-facility
hemodialysis. This includes the patient's right to receive resource
materials for dialysis modalities not offered by the facility. We
expect that all ESRD facilities comply with this regulation and furnish
resource information on home hemodialysis, even if this modality is not
offered by the facility. When ESRD facilities are certified for home
dialysis training we expect the facility to provide training throughout
the self-dialysis or home dialysis experience (42 CFR 494.100). Self-
dialysis or home dialysis training services and supplies may include
but are not limited to personnel services; dialysis supplies,
parenteral items used in dialysis, written training manuals and
materials, and ESRD-related items and services.
We discuss Medicare's training policies in Table 5 (Medicare's Self
or Home Training by Modality) for the following dialysis modalities:
Home Hemodialysis Training
Intermittent Peritoneal Dialysis Training
Continuous Ambulatory Peritoneal Dialysis Training
Continuous Cycling Peritoneal Dialysis Training
We would expect that patients who elect self-dialysis or home dialysis
training will be good candidates for these modalities and that they
will be successful in completing the method of training. This includes
compliance with patient assessments as described in 42 CFR 494.80(a)(9)
``Evaluation of the patient's abilities, interests, preferences, and
goals, including the desired level of participation in the dialysis
care process; the preferred modality (hemodialysis or peritoneal
dialysis), and setting (for example, home dialysis), and the patients
expectations of care outcomes.''
Table 5--Medicare's Self or Home Training by Modality
------------------------------------------------------------------------
------------------------------------------------------------------------
Home Hemodialysis (HHD) HHD training is generally furnished in 4
Training. weeks. Medicare will pay the ESRD
facility for up to 25 HHD training
sessions. In some HHD programs, the
dialysis caregiver is trained to perform
the dialysis treatment in its entirety
and the patient plays a secondary role.
In other programs, the patient performs
most of the treatment and is only aided
by a helper.
Intermittent Peritoneal IPD training is generally furnished in 4
Dialysis (IPD) Training. weeks. Medicare will pay the ESRD
facility for up to 15 PD training
sessions. In the IPD program, the
patient's caregiver is usually trained
to carry out the dialysis care. The
patient plays a minimal role, as most
are unable to perform self-care dialysis
because of other debilitating
conditions.
Continuous Ambulatory CAPD training is generally furnished in 2
Peritoneal Dialysis (CAPD) weeks. Medicare will pay the ESRD
Training. facility for up to 15 PD training
sessions. In CAPD programs both the
patient and the caregiver are trained.
Continuous Cycling Peritoneal CCPD training is generally furnished in 2
Dialysis (CCPD) Training. weeks. Medicare will pay the ESRD
facility for up to 15 PD training
sessions. In CCPD programs both the
patient and the caregiver are trained.
------------------------------------------------------------------------
b. Payment Methodology
In our CY 2011 ESRD PPS final rule (75 FR 49062 through 49064), we
stated that the ESRD PPS base rate alone does not account for the
staffing costs associated with training treatments furnished by a
registered nurse. Thus, we finalized the training add-on payment
adjustment, to be added on to the ESRD PPS base rate, when one-on-one
self or home dialysis training is furnished by a nurse, working for a
Medicare-certified training facility, to a Medicare beneficiary for
either hemodialysis or the peritoneal dialysis training modalities
listed above. Likewise, we noted in our CY 2012 ESRD PPS final rule (76
FR 70252), that ``ESRD facilities receive a per-treatment payment that
accounts for case-mix, geographic location, low-volume, and outlier
payment regardless [of whether] the patient receives dialysis at home
or in the facility, plus the training add-on[,]'' if applicable.
The add-on payment adjustment is also for retraining sessions after
a patient or caregiver has completed the initial training program and
if the patient continues to be an appropriate candidate for self or
home dialysis modalities. We would expect that most Medicare
beneficiaries receive retraining sessions when they receive new
equipment, have a change in caregiver, or modality change. The ESRD
facility may not bill Medicare for retraining services when they
install home dialysis equipment or furnish monitoring services. For
example, an ESRD facility nurse may not bill for retraining sessions
when they update a home dialysis patient's treatment record, order
monthly supplies, or instruct the patient on the use of a new
medication for the treatment of infection. When retraining sessions are
furnished to a patient or caregiver, there is an expectation that the
patient or caregiver is already knowledgeable of the elements of home
dialysis, and if additional training is being done for a change of
equipment or a change in modality, fewer sessions would be necessary
because of the transferability of certain basic skills for home
dialysis.
We discuss our policy for retraining sessions in the Medicare
Benefit Policy Manual, Publication 100-02, Chapter 11. If a Medicare
beneficiary exceeds the maximum amount of training sessions based upon
their modality, and, if they continue to be a good candidate for home
modalities, additional training sessions or retraining sessions may be
paid by Medicare with medical justification. In such cases, the ESRD
facility must indicate the medical justification on the claim for the
training or retraining session submitted for payment. Because the
requirement of medical justification is specific to the patient's
training needs, circumstances (such as a change in caregiver), or
condition (change in modality), we
[[Page 40854]]
would not expect that an ESRD facility would routinely bill Medicare
for training or retraining sessions on any patient.
For CY 2011, we finalized the amount for the training add-on
adjustment at $33.44 per treatment, and noted that this amount would be
added to the ESRD PPS base rate payment when a training treatment is
furnished by the ESRD facility. In addition, we noted that because the
training add-on adjustment is directly related to nursing salaries and
that nursing salaries differ greatly based on geographic location, we
would adjust the training add-on payment by the geographic area wage
index applicable to the ESRD facility. (For further discussions on wage
indexes, please see section II.B.4. of this proposed rule.) When home
dialysis training sessions are furnished to a Medicare beneficiary by a
Medicare-certified training facility, Medicare will make the ESRD PPS
computed base rate payment with all applicable adjustments, and then
the separate add-on payment for self or home dialysis training.
In our CY 2013 ESRD final rule (77 FR 67468 through 67469), we
addressed comments on Medicare's self and home dialysis training
policies under the ESRD PPS. In that final rule, we stated that
commenters were concerned that the payment for home dialysis training
is insufficient and does not reflect the true costs of training and
that they indicated various ranges of time required for home training
in terms of time per day and number of training sessions. At that time,
we responded to those comments by confirming that CMS will continue to
monitor and analyze trends in home dialysis training, but that we
believe our payment methodology is adequate for ESRD facilities
furnishing training services.
In this proposed rule we are seeking comments on the costs
associated with furnishing self or home dialysis training. We request
comments on the elements of PD vs. HHD training sessions, specifically
the costs of furnishing such training, the appropriate number of
training sessions, and the duration of the training sessions. Lastly,
we are also seeking comments on a ``holdback'' payment methodology,
which we discussed in the CY 2011 ESRD PPS final rule (75 FR 49063).
Under this methodology, a portion of the training payments would be
withheld from the ESRD facility until the ESRD patient demonstrates
that they have successfully transitioned to a home modality.
Specifically, we are seeking comments on the length of time necessary
for a successful transition to a home dialysis modality and the
percentage of the payment that should be held back.
D. Delay of Payment for Oral-Only Drugs Under the ESRD PPS
Section 1881(b)(14)(A)(i) of the Act, as added by section 153(b) of
the Medicare Improvements for Patients and Providers Act of 2008
(MIPPA), requires the Secretary to implement a payment system under
which a single payment is made to a provider of services or a renal
dialysis facility for ``renal dialysis services'' in lieu of any other
payment. Section 1881(b)(14)(B) defines renal dialysis services, and
subclause (iii) of that section states that these services include
``other drugs and biologicals that are furnished to individuals for the
treatment of ESRD and for which payment was (before the application of
this paragraph) made separately under this title, and any oral
equivalent form of such drug or biological[.]'' We interpreted this
provision as including not only injectable drugs and biologicals (other
than ESAs, which are included under clause (ii)) used for the treatment
of ESRD, but also all non-injectable drugs furnished under Title XVIII.
We also concluded that, to the extent ESRD-related oral-only drugs do
not fall within clause (iii) of the statutory definition of renal
dialysis services, such drugs would fall under clause (iv), and
constitute other items and services used for the treatment of ESRD that
are not described in clause (i). Accordingly, we defined ``renal
dialysis services'' at 42 CFR 413.174 as including, among other things,
``[o]ther items and services that are furnished to individuals for the
treatment of ESRD and for which payment was (prior to January 1, 2011)
made separately under title XVIII of the Act (including drugs and
biologicals with only an oral form).'' Although oral-only drugs are
included in the definition of renal dialysis services, in the CY 2011
ESRD PPS final rule, we also finalized a policy to delay payment for
these drugs under the PPS until January 1, 2014 (75 FR 49044). We
stated that there were certain advantages to delaying the
implementation of payment for oral-only drugs, including allowing ESRD
facilities additional time to make operational changes and logistical
arrangements in order to furnish oral-only ESRD-related drugs and
biologicals to their patients. Accordingly, 42 CFR 413.174(f)(6)
provides that payment to an ESRD facility for renal dialysis service
drugs and biologicals with only an oral form is incorporated into the
PPS payment rates effective January 1, 2014.
On January 3, 2013, Congress enacted the American Taxpayer Relief
Act of 2012 (ATRA). Section 632(b) of ATRA states that the Secretary
``may not implement the policy under section 413.176(f)(6) of title 42,
Code of Federal Regulations (relating to oral-only ESRD-related drugs
in the ESRD prospective payment system), prior to January 1, 2016.''
Accordingly, payment for oral-only drugs will not be made under the
ESRD PPS before January 1, 2016, instead of on January 1, 2014, which
is the date originally finalized for payment of ESRD-related oral-only
drugs under the ESRD PPS (75 FR 49044). We propose to pay for oral-only
drugs consistent with section 632(b) of ATRA and implement this delay
by revising the effective date for providing payment for oral-only
ESRD-related drugs under the ESRD PPS at section 42 CFR 413.174(f)(6)
from January 1, 2014 to January 1, 2016.
Because we propose that oral-only drugs will be included in the
ESRD PPS starting in CY 2016, we also propose to change the reference
to January 1, 2014 in section 42 CFR 413.237(a)(1)(iv) to January 1,
2016. In the CY 2011 ESRD PPS final rule (75 FR 49138), we defined
outlier services as including oral-only drugs effective January 1,
2014. In addition to modifying the date on which oral-only drugs will
be eligible for outlier payments, we also propose to clarify our
regulation at 413.237(a)(1)(iv) by changing the word ``excluding'' to
``including'' to make clear that oral-only drugs are ESRD outlier
services for purposes of the outlier policy effective January 1, 2016,
consistent with the policy we established in the CY 2011 final rule (75
FR 49138).
III. End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP)
A. Background
For more than 30 years, monitoring the quality of care provided to
patients with end-stage renal disease (ESRD) by dialysis facilities has
been an important component of the Medicare ESRD payment system. The
ESRD quality incentive program (QIP) is the most recent step in
fostering improved patient outcomes by establishing incentives for
dialysis facilities to meet or exceed performance standards established
by CMS. The ESRD QIP is authorized by section 1881(h) of the Social
Security Act (the Act), which was added by section 153(c) of Medicare
Improvements for Patients and Providers Act (MIPPA). CMS established
the ESRD QIP for payment year (PY) 2012, the initial year of the
program in which payment reductions
[[Page 40855]]
were applied, in two rules published in the Federal Register on August
12, 2010, and January 5, 2011 (75 FR 49030 and 76 FR 628,
respectively). Subsequently, on November 10, 2011, CMS published a rule
in the Federal Register outlining the PY 2013 and PY 2014 ESRD QIP
requirements (76 FR 70228). On November 9, 2012, CMS published a rule
in the Federal Register outlining the ESRD QIP requirements for PY 2015
and future payment years (77 FR 67450).
Section 1881(h) of the Act requires the Secretary to establish an
ESRD QIP by (i) selecting measures; (ii) establishing the performance
standards that apply to the individual measures; (iii) specifying a
performance period with respect to a year; (iv) developing a
methodology for assessing the total performance of each facility based
on the performance standards with respect to the measures for a
performance period; and (v) applying an appropriate payment reduction
to facilities that do not meet or exceed the established Total
Performance Score (TPS). This proposed rule discusses each of these
elements and our proposals for their application to PY 2016 and future
payment years of the ESRD QIP. As of January 1, 2014, ESRD facilities
located in Guam, American Samoa, and the Northern Mariana Islands will
be paid under the ESRD PPS. Under section 1881(h)(1)(A) of the Act,
these facilities will receive a reduction to their ESRD PPS payments,
beginning with January 1, 2014 dates of service, if they do not meet
the requirements of the ESRD QIP.
B. Considerations in Updating and Expanding Quality Measures Under the
ESRD QIP for PY 2016 and Subsequent PYs
1. Value-Based Purchasing (VBP) Overview
Throughout the past decade, Medicare has been transitioning from a
program that pays for healthcare based on particular services furnished
to a beneficiary to a program that ties payments to providers and
suppliers based on the quality of services they deliver. By paying for
the quality of care rather than quantity of care, we believe we are
strengthening the healthcare system by focusing on better care and
lower costs through improvement, prevention and population health,
expanded healthcare coverage, and enterprise excellence--while also
advancing the National Strategy for Quality Improvement in Health Care
(National Quality Strategy). CMS is currently working to update a set
of domains and specific measures of quality for our VBP programs, and
to link the aims of the National Quality Strategy with our payment
policies on a national scale. We are working in partnership with
beneficiaries, providers, advocacy groups, the National Quality Forum
(NQF), the Measures Application Partnership, operating divisions within
the Department of Health and Human Services (HHS), and other
stakeholders to develop new measures where gaps exist, refine measures
requiring adjustment, and remove measures when appropriate. We are also
collaborating with stakeholders to ensure that the ESRD QIP serves the
needs of our beneficiaries and also advances the goals of the National
Quality Strategy to coordinate healthcare delivery, reduce healthcare
costs, enhance patient satisfaction, promote healthy communities, and
increase patient safety.\1\
---------------------------------------------------------------------------
\1\ 2012 Annual Progress Report to Congress: National Strategy
for Quality Improvement in Health Care, https://www.ahrq.gov/workingforquality/nqs/nqs2012annlrpt.pdf.
---------------------------------------------------------------------------
We believe that the development of an ESRD QIP that is successful
in supporting the delivery of high-quality healthcare services in
dialysis facilities is paramount. We seek to adopt measures for the
ESRD QIP that promote better, safer, and more efficient care. Our
measure development and selection activities for the ESRD QIP take into
account national priorities such as those established by the National
Priorities Partnership (https://www.nationalprioritiespartnership.org/),
HHS Strategic Plan (https://www.hhs.gov/secretary/about/priorities/priorities.html), the National Strategy for Quality Improvement in
Healthcare (https://www.healthcare.gov/center/reports/quality03212011a.html), and the HHS National Action Plan to Prevent
Healthcare Associated Infections (HAIs) (https://www.hhs.gov/ash/initiatives/hai/esrd.html). To the extent feasible and practicable, we
have sought to adopt measures that have been endorsed by a national
consensus organization, recommended by multi-stakeholder organizations,
and developed with the input of providers, beneficiaries, and other
stakeholders.
2. Brief Overview of Proposed PY 2016 Measures
For the PY 2016 ESRD QIP and future payment years, we are proposing
a total of 14 measures. We believe that the PY 2016 ESRD QIP proposed
measures promote high-quality care for patients with ESRD, and also
strengthen the goals of the National Quality Strategy. The following
measures seek to evaluate facilities on the clinical quality of care:
To evaluate anemia management:
[cir] Hemoglobin Greater Than 12 g/dL, a clinical measure
[cir] Patient Informed Consent for Anemia Treatment, a clinical
measure*
[cir] Pediatric Iron Therapy, a reporting measure*
[cir] Anemia Management, a reporting measure (revised)
To evaluate dialysis adequacy:
[cir] A Kt/V measure for adult hemodialysis patients, a clinical
measure
[cir] A Kt/V measure for adult peritoneal dialysis patients, a
clinical measure
[cir] A Kt/V measure for pediatric hemodialysis patients, a
clinical measure
To determine whether patients are treated using the most
beneficial type of vascular access:
[cir] An arterial venous (AV) fistula measure, a clinical measure
[cir] A catheter measure, a clinical measure
To address effective bone mineral metabolism management:
[cir] Hypercalcemia, a clinical measure*
[cir] Mineral Metabolism, a reporting measure (revised)
To address patient safety:
[cir] National Healthcare Safety Network (NHSN) Bloodstream
Infection in Hemodialysis Outpatients, a clinical measure*
To address patient-centered experience:
[cir] In-Center Hemodialysis Consumer Assessment of Healthcare
Providers and Systems (ICH CAHPS), a reporting measure**
To gather data regarding comorbidities:
[cir] Comorbidity, a reporting measure*
** Indicates that the measure is new to the ESRD QIP.
*** Indicates that the measure is newly expanded or converted to
a clinical measure in the ESRD QIP.
At this time, we are not proposing to adopt measures that address
care coordination, efficiency, population and community health, or cost
of care. However, we are soliciting comments in this proposed rule on
potential measures that would cover these areas. We welcome further
comments on these and other potential measures for future program
years.
3. Measures Application Partnership Review
Section 1890A(a)(1) of the Act, as added by section 3014(b) of the
[[Page 40856]]
Affordable Care Act, requires the entity with a contract under section
1890(a) of the Act (currently the NQF) to convene multi-stakeholder
groups to provide input to the Secretary on the selection of quality
and efficiency measures for use in certain programs. Section
1890A(a)(2) of the Act requires the Secretary to make available to the
public (not later than December 1 of each year) a list of quality and
efficiency measures that are under consideration for use in certain
programs. Section 1890A(a)(3) of the Act requires the entity with a
contract under section 1890(a) of the Act to transmit the input of the
multi-stakeholder groups to the Secretary not later than February 1 of
each year, beginning in 2012. Section 1890A(a)(4) of the Act requires
the Secretary to take into consideration the input of the multi-
stakeholder groups in selecting quality and efficiency measures. The
Measures Application Partnership is the public/private partnership
comprised of multi-stakeholder groups convened by NQF for the primary
purpose of providing input on measures as required by sections
1890A(a)(1) and (3) of the Act. The Measures Application Partnership's
input on the quality and efficiency measures under consideration for
adoption in CY 2013 was transmitted to the Secretary on February 1,
2013, and is available at (https://www.qualityforum.org/Setting_Priorities/Partnership/MAP_Final_Reports.aspx). As required by
section 1890A(a)(4) of the Act, we considered these recommendations in
selecting quality and efficiency measures for the ESRD QIP.
We publicly made available a number of measures in accordance with
section 1890A(a)(2) of the Act, and these measures were reviewed by the
Measures Application Partnership. Of these measures, a subset is
related to a number of proposed new measures for the PY 2016 ESRD QIP
(one each for anemia management, hypercalcemia, infection monitoring,
comorbidity reporting, and ESA usage). The Measures Application
Partnership supported the following:
NQF-endorsed measure NQF 1454: Proportion of patients
with hypercalcemia
NQF-endorsed measure NQF 1433: Use of Iron Therapy
for Pediatric Patients (which forms the basis for the proposed
Pediatric Iron Therapy reporting measure)
NQF-endorsed measure NQF 1460: National Healthcare
Safety Network (NHSN) Bloodstream Infection Measure (which forms the
basis for the proposed Bloodstream Infection in Hemodialysis
Outpatients clinical measure)
NQF-endorsed measure NQF 0369: Dialysis Facility
Risk-adjusted Standardized Mortality Ratio (the proposed Comorbidity
reporting measure may assist in calculating performance on this
measure, should we propose to adopt it in the future)
The Measures Application Partnership supported the direction of the
following measures:
NQF-endorsed measure NQF 1463: Standardized
Hospitalization Ratio for Admissions (the proposed Comorbidity
reporting measure may assist in calculating performance on this
measure, should we propose to adopt it in the future)
Measures Application Partnership 2774: Blood
Transfusion Appropriateness (which forms the basis for the Patient
Informed Consent for Anemia Treatment clinical measure)
We have taken comments from the Measures Application Partnership
and the NQF into consideration for the PY 2016 ESRD QIP. In the
measures section below, we further discuss these considerations,
describe our proposals for the PY 2016 ESRD QIP, and provide rationale
for why we believe it is appropriate to propose the measures at this
time.
C. Proposed Measures for the PY 2016 ESRD QIP and Subsequent PYs of the
ESRD QIP
We previously finalized ten measures in the CY 2013 ESRD PPS final
rule for the PY 2015 ESRD QIP and future PYs (77 FR 67471), and these
measures are summarized in Table 6 below. We are proposing to continue
to use nine of the ten measures for the PY 2016 ESRD QIP and future
payment years, modifying three of the measures as follows:
ICH CAHPS (reporting measure): Expand
Mineral Metabolism (reporting measure): Revise
Anemia Management (reporting measure): Revise
For the PY 2016 ESRD QIP and future payment years, we are also
proposing to add three new clinical measures (Patient Informed Consent
for Anemia Treatment, Hypercalcemia, and NHSN Bloodstream Infection in
Hemodialysis Outpatients), and two new reporting measures (Pediatric
Iron Therapy, and Comorbidity). (See Table 7) We believe that,
collectively, these measures will continue to promote improvement in
dialysis care in the PY 2016 ESRD QIP and in future payment years.
Table 6--Measures Adopted for the PY 2015 ESRD QIP and Future Payment
Years
------------------------------------------------------------------------
NQF No. Measure title and description
------------------------------------------------------------------------
N/A...................... Anemia Management: Hgb >12.
Percentage of Medicare patients with a mean
hemoglobin value greater than 12 g/dL.
0249..................... Hemodialysis Adequacy: Minimum delivered
hemodialysis dose.
Percent of hemodialysis patient-months with
spKt/V greater than or equal to 1.2.
0318..................... Peritoneal Dialysis Adequacy: Delivered dose
above minimum.
Percent of peritoneal dialysis patient-months
with spKt/V greater than or equal to 1.7
(dialytic + residual) during the four month
study period.
1423..................... Pediatric Hemodialysis Adequacy: Minimum spKt/
V.
Percent of pediatric in-center hemodialysis
patient-months with spKt/V greater than or
equal to 1.2.
0257..................... Vascular Access Type: Arterial Venous (AV)
Fistula.
Percentage of patient-months on hemodialysis
during the last hemodialysis treatment of
the month using an autogenous AV fistula
with two needles.
0256..................... Vascular Access Type: Catheter >= 90 days.
Percentage of patient-months for patients on
hemodialysis during the last hemodialysis
treatment of month with a catheter
continuously for 90 days or longer prior to
the last hemodialysis session.
N/A \1\.................. National Healthcare Safety Network (NHSN)
Dialysis Event Reporting.
Number of months for which facility reports
NHSN Dialysis Event data to the Centers for
Disease Control and Prevention (CDC).
N/A \2\.................. In-Center Hemodialysis Consumer Assessment of
Healthcare Providers and Systems (ICH CAHPS)
Survey Administration \+\.
Attestation that facility administered survey
in accordance with specifications.
[[Page 40857]]
N/A \3\.................. Mineral Metabolism Reporting \+\.
Number of months for which facility reports
uncorrected serum calcium and phosphorus for
each Medicare patient.
N/A...................... Anemia Management Reporting \+\.
Number of months for which facility reports
ESA dosage (as applicable) and hemoglobin/
hematocrit for each Medicare patient.
------------------------------------------------------------------------
\1\ We note that an NQF-endorsed bloodstream infection measure
(NQF1460) exists.
\2\ We note that a related measure utilizing the results of this survey
has been NQF-endorsed (0258). It is our intention to use this
measure in future years of the ESRD QIP. We believe that a reporting
measure is a necessary step in reaching our goal to implement
NQF0258.
\3\ We note that this measure is based upon a current NQF-endorsed serum
phosphorous measure (0255), and a calcium monitoring measure
that NQF had previously endorsed (0261).
\+\ Indicates a measure we are proposing to revise for PY 2016 and
future years of the ESRD QIP.
Table 7--New Measures Proposed for the PY 2016 ESRD QIP and Future
Payment Years
------------------------------------------------------------------------
NQF No. Measure title
------------------------------------------------------------------------
N/A...................... Anemia of chronic kidney disease: Patient
Informed Consent for Anemia Treatment.
N/A \1\.................. Use of Iron Therapy for Pediatric Patients
Reporting.
1454..................... Proportion of Patients with Hypercalcemia.
N/A \2\.................. NHSN Bloodstream Infection in Hemodialysis
Outpatients.
N/A \3\.................. Comorbidity Reporting.
------------------------------------------------------------------------
\1\ We note that the NQF has previously endorsed a pediatric iron
therapy measure (1433) upon which this measure is based.
\2\ We note that the NQF has previously endorsed a National Healthcare
Safety Network (NHSN) bloodstream infection measure (1460)
upon which this measure is based.
\3\ We note that the NQF has previously endorsed risk-adjusted
hospitalization and mortality measures (1463 and 0369). The proposed Comorbidity reporting measure may assist in
calculating performance on these measures, should we propose to adopt
them in the future.
1. PY 2015 Measures Continuing in PY 2016 and Future Payment Years
We are continuing using six measures adopted in the CY 2013 ESRD
PPS final rule for the PY 2016 ESRD QIP and future payment years of the
program. We are also continuing to use two measure topics adopted.
Proposals for scoring these measures are discussed in sections III.C.5
through III.C.11 and III.C.13. For the reasons stated in the CY 2012
ESRD PPS final rule (76 FR 70262, 70264 through 70265, 70269) and in
the CY 2013 ESRD PPS final rule (77 FR 67478 through 67480, 67487
through 67490), we will continue using:
1. (i) The Hemoglobin Greater than 12 g/dL measure.
The Dialysis Adequacy measure topic, which is comprised of
2. (a) Hemodialysis Adequacy Clinical Performance Measure III:
Hemodialysis Adequacy--HD Adequacy--Minimum Delivered Hemodialysis Dose
(NQF 0249),
3. (b) Peritoneal Dialysis Adequacy Clinical Performance Measure
III--Delivered Dose of Peritoneal Dialysis Above Minimum (NQF
0318); and
4. (c) Minimum spKt/V for Pediatric Hemodialysis Patients (NQF
1423); and
The Vascular Access Type measure topic, which is comprised of
5. (a) Vascular Access Type: Arterial Venous (AV) Fistula (NQF
0257); and
6. (b) Vascular Access Type: Catheter >= 90 days (NQF
0256).
The technical specifications for these measures can be found at: https://www.dialysisreports.org/ESRDMeasures.aspx.
2. Proposal To Expand One PY 2015 Measure and Revise Two PY 2015
Measures for PY 2016 and Subsequent Payment Years
As stated earlier, we believe it is important to continue using
measures from one payment year to the next payment year of the program
to encourage continued improvements in patient care. Therefore, we are
proposing to expand and revise the measures discussed below that we
finalized in the CY 2013 ESRD PPS final rule. For all measures except
for ICH CAHPS reporting measure, these proposed and revised
requirements would apply to the measures for PY 2016 and future payment
years. For the ICH CAHPS measure, certain proposed expanded
requirements would apply to PY 2016, and some additional proposed
requirements would apply to PY 2017 and future payment years.
a. Proposed Expanded ICH CAHPS Reporting Measure
Patient-centered experience is an important measure of the quality
of patient care. It is a component of the National Quality Strategy.
The NQF endorses and the Measures Application Partnership supports a
clinical measure on this topic, NQF 0285: CAHPS In-Center
Hemodialysis Survey, which is based on how facilities perform on the
CAHPS survey. In PY 2015, we continued to use a reporting measure
related to the ICH CAHPS survey, requiring that facilities attest they
had administered the survey according to the specifications set by the
Agency for Healthcare Research and Quality (AHRQ), but not requiring
the submission of survey data. We required that facilities attest by
January 31, 2014 to administering the ICH CAHPS survey during the
performance period (77 FR 67480 through 67481).
We are taking several steps to develop the baseline data necessary
to propose and implement NQF 0258 as a clinical measure in the
PY 2018 ESRD QIP. We expect to be able to certify ICH CAHPS survey
vendors beginning in early CY 2014. We are also building the capacity
to accept survey data, developing detailed specifications for
administering the ICH-CAHPS survey in light of questions vendors asked
about previous procedures, and developing specifications for submitting
data to CMS, such as file specifications, structure and instructions
that the survey vendors will use. We have taken these steps in order to
make it possible for facilities to contract with third party vendors to
transfer survey data results to CMS, so that we might collect the
baseline data necessary to propose and implement NQF 0258.
For PY 2016, we are proposing that each facility arrange by July
2014 for a CMS-approved vendor to conduct the
[[Page 40858]]
ICH CAHPS survey according to CMS (rather than AHRQ) specifications,
available at the ICH CAHPS Web site (https://ichcahps.org). Facilities
will need to register on the https://ichcahps.org Web site in order to
authorize the CMS-approved vendor to administer the survey and submit
data on their behalf. Each facility must then administer (via its
vendor) the survey once during the proposed performance period and, by
11:59 ET on January 28, 2015, report the survey data to CMS using the
specifications on the ICH CAHPS Web site.
For PY 2017 and subsequent payment years, we are proposing similar
requirements except that each facility must arrange to have the survey
administered twice during each performance period and must report the
data (via its CMS-approved vendor) to CMS by the date specified on the
ICH CAHPS Web site.
Although we have required that other types of providers, including
home health agencies and acute care hospitals, administer and submit
CAHPS survey data on a monthly, continuous basis, we recognize that
there are generally low rates of turnover in dialysis facility patient
populations. For this reason, we do not see the same need to require
facilities to administer the survey as frequently and, as proposed
above, would require facilities to administer the survey once during
the performance period for PY 2016 (in order to allow facilities enough
time to select a vendor) and twice for subsequent payment years. We
believe that this frequency of survey administration will enable us to
gather sufficient data to adopt in future rulemaking, a clinical
version of this measure without unduly burdening facilities. We request
comment on this proposal. The technical specifications for this measure
are located at https://www.dialysisreports.org/pdf/esrd/public-measures/ICHCAHPS-2016NPRM.pdf.
b. Proposed Revised Mineral Metabolism Reporting Measure
Adequate management of bone mineral metabolism and disease in ESRD
patients continues to be a high priority because it can cause severe
consequences such as osteoporosis, osteomalacia, and
hyperparathyroidism. The PY 2015 ESRD QIP has a reporting measure
focused on mineral metabolism (77 FR 67484 through 67487). We are
proposing two changes for PY 2016 and future payment years. First, when
we finalized the measure in the CY 2013 ESRD PPS final rule, we
inadvertently excluded home peritoneal patients from the measure
specifications. For PY 2016 and future payment years, we are now
proposing to include home peritoneal patients in the Mineral Metabolism
reporting measure. Therefore, we are proposing that a qualifying case
for this measure will be defined as (i) an in-center Medicare patient
who had been treated at least seven times by the facility; and (ii) a
home dialysis Medicare patient for whom the facility submitted a claim
at least once per month.
Second, if the proposed Hypercalcemia clinical measure (described
below) is finalized based on public comment, then we believe it would
be redundant, and unduly burdensome, for facilities to also continue
reporting serum calcium levels as part of the mineral metabolism
reporting measure. Accordingly, in light of our proposal to adopt the
hypercalcemia measure, we are proposing to change the specifications
for the mineral metabolism measure such that it no longer requires
facilities to report serum calcium levels. We welcome comments on this
proposal, and in particular on whether we should retain the reporting
of serum calcium levels as part of the mineral metabolism reporting
measure if we do not finalize the proposed hypercalcemia measure.
As described in more detail below (Proposed Minimum Data for
Scoring Measures), we are also proposing to eliminate the 11-case
minimum for this measure, which was finalized in the CY 2013 ESRD PPS
final rule at 77 FR 67486. Because of the proposed revised case
minimum, and because there are circumstances that might make it
challenging for a facility to draw a sample from certain patients, such
as those who are admitted to hospital during the month, we are
proposing that, in order to receive full points on this measure,
facilities that treat 11 or more qualifying cases over the entire
performance period will have to report at the lesser of the 50th
percentile of facilities in CY 2013 or 97 percent per month, on a
monthly basis, for each month of the performance period. We are further
proposing that facilities that treat fewer than 11 qualifying cases
during the performance period will have to report on a monthly basis
the specified levels for all but one qualifying case. If a facility
only has one qualifying case during the entire performance period, a
facility will have to attest to that fact in CROWNWeb by January 31 of
the year following the performance period in order to avoid being
scored on the measure. We make this proposal because we seek to ensure
the highest quality of care regardless of facility size, and because we
seek to mitigate cherry-picking by ensuring that one patient does not
skew a facility's score (77 FR 67474).
We welcome comments on this proposal. Technical specifications for
this proposed measure can be found at: https://www.dialysisreports.org/pdf/esrd/public-measures/MineralMetabolism-Hypercalcemia-2016NPRM.pdf.
c. Proposed Revised Anemia Management Reporting Measure
Section 1881(h)(2)(A)(i) requires ``measures on anemia management
that reflect the labeling approved by the Food and Drug Administration
(FDA) for such management.'' In the CY 2013 ESRD PPS final rule, we
finalized an Anemia Management reporting measure for the reasons stated
in that final rule (77 FR 67491 through 67495). However, we
inadvertently excluded home peritoneal patients from the measure
specifications. For PY 2016 and future payment years, we are now
proposing to include home peritoneal patients in the Anemia Management
reporting measure. Therefore, we are proposing that a qualifying case
for this measure will be defined as (i) an in-center Medicare patient
who had been treated at least seven times by the facility; and (ii) a
home dialysis Medicare patient for whom the facility submitted a claim
at least once per month.
We believe that there are circumstances that might make it
challenging to draw a sample from certain patients, and therefore, we
are proposing that, in order to receive full points on this measure,
facilities that treat 11 or more qualifying cases over the entire
performance period must report at the lesser of the 50th percentile of
facilities in CY 2013 or 99 percent per month, on a monthly basis for
each month of the performance period. In addition, we are proposing
that, in order to receive full points on this measure, facilities that
treat fewer than 11 qualifying cases during the performance period must
report on a monthly basis the specified levels for all but one
qualifying case. If a facility only has one qualifying case during the
entire performance period, a facility will have to attest to that fact
in CROWNWeb by January 31 of the year following the performance period
in order to avoid being scored on the measure. We make this proposal
because we seek to ensure the highest quality of care regardless of
facility size, and because we seek to mitigate cherry-picking by
ensuring that one patient does not skew a facility's score (77 FR
67474).
Technical specifications for this proposed measure can be found at:
https://www.dialysisreports.org/pdf/esrd/
[[Page 40859]]
public-measures/AnemiaManagement-Reporting-2016NPRM.pdf. We request
comment on this proposal to revise the Anemia Management reporting
measure.
3. New Measures Proposed for PY 2016 and Subsequent Payment Years of
the ESRD QIP
As the program evolves, we believe it is important to continue to
evaluate and expand the measures selected for the ESRD QIP. Therefore,
for the PY 2016 ESRD QIP and future payment years, we are proposing to
adopt five new measures. The proposed new measures include two measures
on anemia management, one measure on mineral metabolism, one measure on
bloodstream infection monitoring, and one measure on comorbidities.
a. Proposed Anemia Management Clinical Measure Topic and Measures
Section 1881(h)(2)(A)(i) of the Act states that the measures
specified for the ESRD QIP are required to include measures on ``anemia
management that reflect the labeling approved by the Food and Drug
Administration for such management.'' For PY 2016 and future payment
years, we are proposing to create a new anemia management clinical
measure topic, which consists of one measure initially finalized in the
PY 2012 ESRD QIP final rule and most recently finalized for PY 2015 and
future PYs in the CY 2013 ESRD PPS final rule, and one new proposed
measure, described below. We note that, like other measure topics, we
are proposing that the Anemia Management clinical measure topic consist
only of clinical and not reporting measures.
i. Anemia Management: Hgb>12
For the PY 2016 ESRD QIP and future payment years of the program,
we are proposing to include the current Hgb>12 measure in a new Anemia
Management Clinical Measure Topic. In the event that the Patient
Informed Consent for Anemia Treatment measure described below is not
finalized, we would retain the Hgb>12 measure as an independent
measure. We welcome comments on this proposal.
ii. Anemia of Chronic Kidney Disease: Patient Informed Consent for
Anemia Treatment
This is a measure of the proportion of dialysis patients for whom a
facility attests that risks, potential benefits, and alternative
treatment options for anemia were evaluated, and that the patient
participated in the decision-making regarding an anemia treatment
strategy. We believe that this measure is consistent with recent
changes to the FDA-approved labeling \2\ for ESAs and Kidney Disease:
Improving Global Outcomes (KDIGO) Anemia Management Guidelines \3\ that
highlight the evolving understanding of risks associated with ESA
therapy, as required in section 1881(h)(2)(A)(i) of the Act. We believe
it is appropriate for facilities and physicians to ensure that steps
are taken to make patients aware of those potential risks within the
context of treatment for anemia. For these reasons, we are proposing to
adopt this measure (Anemia of Chronic Kidney Disease: Patient Informed
Consent for Anemia Treatment) for the ESRD QIP in PY 2016 and future
payment years of the program. In order to meet the requirements of this
proposed measure, facilities must attest in CROWNWeb for each
qualifying patient, on an annual basis, that informed consent was
obtained from that patient, or that patient's legally authorized
representative, during the performance period. We propose that
qualifying cases for this measure would be defined as patients who
received dialysis in the facility for 30 days or more. The proposed
deadline for reporting these attestations for the PY 2016 ESRD QIP will
be January 31, 2015 or, if that is not a regular business day, the
first business day thereafter. Missing attestation data for a patient
will be interpreted as failure to obtain informed consent from that
patient.
---------------------------------------------------------------------------
\2\ https://www.fda.gov/Drugs/DrugSafety/ucm259639.htm.
\3\ Kidney Disease: Improving Global Outcomes (KDIGO) Anemia
Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic
Kidney Disease. Kidney inter., Suppl. 2012 (2): 279-335.
---------------------------------------------------------------------------
We welcome comments on this proposed measure. Technical
specifications for this proposed measure can be found at: https://www.dialysisreports.org/pdf/esrd/public-measures/AnemiaManagement-InformedConsent-2016NPRM.pdf.
b. Hypercalcemia
Section 1881(h)(2)(A)(iii)(II) of the Act states that the measures
specified for the ESRD QIP shall include other measures as the
Secretary specifies, including, to the extent feasible, measures of
bone mineral metabolism. Abnormalities of bone mineral metabolism are
exceedingly common, and contribute significantly to morbidity and
mortality in patients with advanced Chronic Kidney Disease (CKD). Many
studies have associated disorders of mineral metabolism with mortality,
fractures, cardiovascular disease, and other morbidities. Therefore, we
believe it is critical to adopt a clinical measure that encourages
adequate management of bone mineral metabolism and disease in ESRD
patients.
Elevated serum calcium level (or hypercalcemia) has been shown to
be significantly associated with increased all-cause mortality in
patients with advanced Chronic Kidney Disease (CKD). Both KDIGO
Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention,
and Treatment of Chronic Kidney Disease--Mineral and Bone Disorder
(CKD--MBD) and the National Kidney Foundation's Kidney Disease Outcomes
Quality Initiative (KDOQI) support maintaining serum calcium levels
within reference ranges. Hypercalcemia is also a proxy for vascular
and/or valvular calcification 4 5 and subsequent risk for
cardiovascular deaths. We previously proposed a hypercalcemia clinical
measure for the PY 2015 ESRD QIP (77 FR 40973 through 40974), but
decided not to finalize the measure because we lacked baseline data
that could be used to calculate performance standards, achievement
thresholds, and benchmarks (77 FR 67490 through 67491). We now possess
enough baseline data to calculate these values. Therefore, we are
proposing to adopt the NQF-endorsed measure NQF 1454:
Proportion of Patients with Hypercalcemia, for PY 2016 and future
payment years of the ESRD QIP.
---------------------------------------------------------------------------
\4\ Wang A, Woo J, Law C, et al. Cardiac Valve Calcification as
an Important Predictor for All-Cause Mortality and Cardiovascular
Mortality in Long-Term Peritoneal Dialysis Patients: A Prospective
Study. J Am. S. Nephrology 2011 (14/1): 159-168.
\5\ Wang A, Ho S, Wang M, et al. Cardiac Valvular Calcification
as a Marker of Atherosclerosis and Arterial Calcification in End-
stage Renal Disease. JAMA 2005 (165/3): 327-332.
---------------------------------------------------------------------------
The proposed Hypercalcemia measure assesses the number of patients
with uncorrected serum calcium greater than 10.2 mg/dL for a 3-month
rolling average. (``Uncorrected'' means not corrected for serum albumin
concentration.) In order to enable us to calculate this measure, each
facility will be required to enter in CROWNWeb, on a monthly basis, an
uncorrected calcium level for each in-center and home dialysis patient
over the age of eighteen.
Performance on this measure is expressed as a proportion of
patient-months for which the 3-month rolling average exceeds 10.2 mg/
dL. The numerator is the total number of eligible patient-months where
the 3-month rolling average is greater than 10.2 mg/dL and the
demoninator is the total number of eligible patient-months. We are
proposing that facilities would begin to submit data on this measure
based on January 2014 uncorrected serum
[[Page 40860]]
calcium levels but that we would calculate the first 3-month rolling
average for each eligible patient in March 2014 using January,
February, and March 2014 data. We would then calculate a new 3-month
rolling average each successive eligible patient-month (April through
December measure calculations) by dropping the oldest month's data and
using instead the newest month's data in the 3-month period. The
facility's performance will be determined by calculating the proportion
of the 3-month averages calculated monthly (March through December,
each time using the latest three months of data) for all eligible
patients that was greater than 10.2 mg/dL.
Because we are proposing to adopt this measure not only for PY
2016, but also subsequent payment years, we also propose that,
beginning with the PY 2017 program, we would measure hypercalcemia
beginning in January of the applicable performance period. This will
allow us to have a 3-month rolling average for all months in the
performance period. We propose that the 3-month rolling average rate
for January would be calculated using the rates from November and
December of the previous year as well as January of that year.
Likewise, we propose that the rate for February would be calculated
using the rates from December, January and February to calculate the 3-
month rolling average, and so on.
Technical specifications for this measure can be found at https://www.dialysisreports.org/pdf/esrd/public-measures/MineralMetabolism-Hypercalcemia-2016NPRM.pdf. We welcome comments on this proposal.
c. Use of Iron Therapy for Pediatric Patients Reporting Measure
Section 1881(h)(2)(A)(i) states that the ESRD QIP must include
measures on ``anemia management that reflect the labeling approved by
the Food and Drug Administration for such management.'' Appropriate
anemia management requires the presence of sufficient stores of
iron.\6\ Iron deficiency is a leading cause of non-response to ESA
therapy, and several studies suggest that providing oral or IV iron is
effective in correcting iron deficiency in the pediatric
population.7 8 Pediatric patients have previously been
excluded from all anemia management measures, limiting the
participation of dialysis facilities with substantial numbers of
pediatric patients in the ESRD QIP. In an effort to address this issue,
and account for the quality of care dialysis facilities provide to
pediatric patients, we are proposing to adopt a pediatric iron therapy
measure for the ESRD QIP in PY 2016 and future payment years of the
program.
---------------------------------------------------------------------------
\6\ Seeherunvong W, Rubio L, Abitbol CL, et al. Identification
of poor responders to erythropoietin among children undergoing
hemodialysis. J Pediatr 2001 (138/5):710-714.
\7\ Warady BA, Zobrist RH, Wu J, Finan E. Sodium ferric
gluconate complex therapy in anemic children on hemodialysis.
Pediatr Nephrol 20: 1320-7, 2005.
\8\ Frankenfield DL, Neu AM, Warady BA, et al. Anemia in
pediatric hemodialysis patients: Results from the 2001 Clinical
Performance Measures Project. Kidney International 64:1120-4, 2003.
---------------------------------------------------------------------------
We considered proposing an NQF-endorsed clinical measure on the use
of iron therapy for pediatric patients as part of the proposed Anemia
Management clinical measure topic (NQF 1433: Use of Iron
Therapy for Pediatric Patients). This measure is an assessment of the
percentage of all pediatric hemodialysis and peritoneal dialysis
patients who received IV iron or were prescribed oral iron within three
months of attaining the following conditions: (i) Patient had
hemoglobin less than 11.0 g/dL; (ii) patient had simultaneous values of
serum ferritin concentration less than 11.0; and (iii) patient's
transferrin saturation (TSAT) was less than 20 percent. Upon
investigation, we discovered that there were not enough patients who
would qualify for this measure to establish reliable baseline data that
would allow us to propose to adopt this measure as a clinical measure
for PY 2016. We also note that the clinical measure currently presents
other issues related to the minimum number of cases that would need to
be reported for scoring, and we are considering the use of an adjuster
that could be applied where the sample size is small. While we continue
to consider these and other issues related to the adoption of a
pediatric iron therapy clinical measure, we are proposing a related
reporting measure for PY 2016 and future payment years in order to
acquire a sufficient amount of baseline data for the development of a
clinical measure in the future.
For PY 2016 and future payment years, we are proposing that
facilities must enter in CROWNWeb on a quarterly basis, for each
qualifying case (defined in the next sentence): (i) Patient admit/
discharge date; (ii) hemoglobin levels; (iii) serum ferritin levels;
(iv) TSAT percentages; (v) the dates that the lab measurements were
taken for items (ii)-(iv); (vi) intravenous IV iron received or oral
iron prescribed (if applicable); and (vii) the date that the IV iron
was received or oral iron was prescribed (if applicable). We are
proposing that qualifying cases for this measure would be defined as
in-center and home dialysis patients under the age of eighteen.
As described in more detail below, we are proposing that each
facility must report data on the Use of Iron Therapy for Pediatric
Patients measure if it treats one or more qualifying cases during the
performance period. Because this reporting measure requires that a
facility enter data in CROWNWeb only once per quarter for each patient,
we believe that the burden is appropriate and will not unduly impact
small facilities, since it is proportionate to the number of patients
that facilities treat. However, for the same reasons stated in the
final description of the PY 2014 ESRD QIP Mineral Metabolism measure
(which had a one patient minimum) (77 FR 67472 through 67474), we are
proposing that, in order to receive full points on this measure,
facilities that treat 11 or more qualifying cases over the performance
period will have to report at the lesser of the 50th percentile of
facilities in CY 2013 or 97 percent per quarter, for each quarter of
the performance period. We are proposing that facilities that treat
fewer than 11 qualifying cases during the performance period will have
to report on a quarterly basis the specified data elements for all but
one qualifying case. If a facility only has one qualifying case during
the entire performance period, a facility will have to attest to that
fact in CROWNWeb by January 31 of the year following the performance
period in order to avoid being scored on the measure.
The technical specifications for this measure can be found at:
https://www.dialysisreports.org/pdf/esrd/public-measures/AnemiaManagement-PediatricIronTherapyReporting-2016NPRM.pdf. We welcome
comment on this proposal.
d. NHSN Bloodstream Infection in Hemodialysis Outpatients Clinical
Measure
Healthcare-acquired infections (HAI) are a leading cause of
preventable mortality and morbidity across different settings in the
healthcare sector, including dialysis facilities. Bloodstream
infections are a pressing concern in a population where individuals are
frequently immuno-compromised and depend on regular vascular access to
facilitate dialysis therapy. In a national effort to reduce infection
rates, CMS has partnered with the CDC to encourage facilities to report
to the NHSN as a way to track and facilitate action intended to reduce
HAIs. The NHSN is a secure, internet-based surveillance system that is
managed by the Division of Healthcare
[[Page 40861]]
Quality Promotion at the CDC. NHSN has been operational since 2006 and
tracks data from acute care hospitals, long-term care hospitals,
psychiatric hospitals, rehabilitation hospitals, outpatient dialysis
centers, ambulatory surgery centers, and long-term care facilities. We
continue to believe that accurately reporting dialysis events to the
NHSN by these facilities supports national goals for patient safety,
particularly goals for the reduction of HAIs. In addition, we believe
that undertaking other activities designed to reduce the number of HAIs
supports national goals for patient safety. For further information
regarding the NHSN's dialysis event reporting protocols, please see
https://www.cdc.gov/nhsn/dialysis/.
We have worked over the past two years to help dialysis facilities
become familiar with the NHSN system through the adoption of an NHSN
Dialysis Event reporting measure. We now believe that facilities are
sufficiently versed in reporting this measure to the NHSN. In light of
the importance of monitoring and preventing infections in the ESRD
population, and because a clinical measure would have a greater impact
on clinical practice by holding facilities accountable for their actual
performance, we are proposing to replace the NHSN Dialysis Event
reporting measure that we adopted in the CY 2013 ESRD PPS final rule
(77 FR 67481 through 67484) with a new clinical measure for PY 2016 and
future payment years. This proposed measure, NHSN Bloodstream Infection
in Hemodialysis Outpatients, is based closely NQF 1460, in
that it evaluates the number of hemodialysis outpatients with positive
blood cultures per 100 hemodialysis patient-months.
We are proposing that facilities must submit 12 months of
accurately reported dialysis event data (defined in the next sentence)
to NHSN on a quarterly basis. In order to ensure that a facility
submits data that can be used to identify the source of bloodstream
infections, to preserve the internal validity of bloodstream infection
data, and to help prevent future bloodstream infections, we propose to
define accurately reported dialysis event data as data reported by
facilities that follow the NHSN enrollment and training guidelines
specified by the CDC (available at: https://www.cdc.gov/nhsn/dialysis/enroll.html and https://www.cdc.gov/nhsn/Training/dialysis/),
according to the reporting requirements specified within the NHSN
Dialysis Event Protocol. (This protocol, which facilities are already
using to meet the requirements of the NHSN Dialysis Event reporting
measure, includes information about IV antimicrobial starts and
evidence of vascular access site infection, as well as information
about the presence of a bloodstream infection.)
Additionally, we are proposing that each quarter's data would be
due 3 months after the end of that quarter. For example, data from
January 1 through March 31, 2014 would need to be entered by June 30,
2014; data from April 1 through June 30, 2014 would need to be
submitted by September 30, 2014; data from July 1 through September 30,
2014 would need to be submitted by December 31, 2014; data from October
1 through December 31, 2014 would need to be submitted by March 31,
2015. If facilities do not report 12 months of these data according to
the requirements and the deadlines specified above, we propose that
they would receive a score of zero on the measure. We also propose that
facilities with a CCN open date after January 1, 2014 will be excluded
from the measure. We note that in previous payment years we have
awarded partial credit to facilities that submitted less than twelve
months of data to encourage them to enroll in and report data in the
NHSN system. However, we are proposing to require 12 months of data on
this clinical measure because infection rates vary through different
seasons of the year.
We note that this proposed measure only applies to facilities
treating in-center hemodialysis patients (both adult and pediatric). We
will determine whether a facility treats in-center patients by
referencing the facility's information in the Standard Information
Management System and CROWNWeb.
We recognize that the CDC has published Core Interventions for BSI
Prevention in Dialysis, which are listed at https://www.cdc.gov/dialysis/prevention-tools/core-interventions.html. We encourage
facilities to adopt the nine listed interventions in order to help
prevent infections, but are not proposing to require facilities to
adopt any of these interventions at this time.
We request comment on this proposal, and in particular on the issue
of whether it is appropriate at this time to convert the current NHSN
Dialysis Event Reporting measure into a clinical measure. The technical
specifications for this measure are located at https://www.dialysisreports.org/ESRDMeasures.aspx.
e. Comorbidity Reporting Measure
The NQF endorsed a clinical measure for Dialysis Facility Risk-
Adjusted Standardized Mortality Ratio (0369) in 2008, and a
clinical measure for Standardized Hospitalization Ratio for Admissions
(1463) in 2011. We have long been interested in adding a
Standardized Mortality Ratio (SMR) measure and a Standardized
Hospitalization Ratio (SHR) measure to the ESRD QIP. As articulated in
the CY 2013 ESRD PPS final rule, ``We believe that dialysis facilities
own partial responsibility for the rate at which their patients are
hospitalized, in particular when that rate is substantially higher than
at other peer facilities and may not be explained by variation in the
illness of patients'' (77 FR 67496). Similarly, we continue to believe
that the ``SMR may help distinguish the quality of care offered by
dialysis facilities as determined by mortality, a key health care
outcome used to assess quality of care in other settings, such as
hospitals'' (77 FR 67497).
Although we believe that SHR and SMR capture important indicators
of morbidity and mortality, we are considering whether, and how, we
might be able to adopt them through future rulemaking in a way that
properly takes into account the effect that comorbidities have on
hospitalization and mortality rates for the ESRD population. We also
acknowledge concerns raised by commenters in the past that the NQF-
endorsed SMR and SHR measures are not adequately risk adjusted (77 FR
67496). Currently, information about patient comorbidities is collected
by CMS via the Medical Evidence Reporting Form 2728, which is typically
only submitted by facilities to CMS when a new patient first begins to
receive dialysis treatment. We also use Form 2728 to capture the date
of first dialysis in order to help determine patient exclusions for all
of the clinical measures finalized in the PY 2013 ESRD PPS final rule.
However, facilities are not required to update this form, which makes
it difficult to capture information about comorbidities that develop
after the initiation of dialysis treatment. We acknowledge the concerns
of commenters who stated that ``there is currently no mechanism either
for correcting or updating patient comorbidity data on CMS' Medical
Evidence Reporting Form 2728, and these comorbidities affect the
calculation of the measure'' (76 FR 70267).
We are proposing to adopt a Comorbidity reporting measure for the
PY 2016 ESRD QIP and future payment years of the ESRD QIP. The purpose
of this measure is two-fold. First, the proposed reporting measure
offers a
[[Page 40862]]
mechanism for collecting annual information about patient
comorbidities, thereby providing a reliable source of data that we can
use to develop a risk-adjustment methodology for the SHR and SMR
clinical measures, should we propose to adopt such measures in the
future. Second, the reporting measure will make it possible to improve
our understanding of the risk factors that contribute to morbidity and
mortality in the ESRD patient population. The data we gather will
enable us to develop risk-adjustment methodologies for possible use in
calculating the SHR and SMR measures, should we propose to adopt those
measures in the future, and therefore more reliably calculate expected
hospitalization and mortality rates in future payment years of the ESRD
QIP. When we examine updated data on comorbidities, we will determine
the appropriateness of including that data as additional risk-
adjustment factors for the SMR and SHR measures by considering the
extent to which each comorbidity may be influenced by the quality of
dialysis facility care, as opposed to factors outside of a facility's
control.
Section 1881(h)(2)(B)(i) of the Act requires that, unless the
exception set forth in section 1881(h)(2)(B)(ii) of the Act applies,
the measures specified for the ESRD QIP under section
1881(h)(2)(A)(iii) of the Act must have been endorsed by the entity
with a contract under section 1890(a) of the Act (which is currently
NQF). Under the exception set forth in section 1881(h)(2)(B)(ii) of the
Act, in the case of a specified area or medical topic determined
appropriate by the Secretary for which a feasible and practical measure
has not been endorsed by the entity with a contract under section
1890(a) of the Act, the Secretary may specify a measure that is not so
endorsed, so long as due consideration is given to measures that have
been endorsed or adopted by a consensus organization identified by the
Secretary.
NQF has not endorsed a measure for updating comorbidity information
for patients with ESRD. We have given due consideration to endorsed
measures, as well as those adopted by a consensus organization, and we
are proposing this measure under the authority of 1881(h)(2)(B)(ii) of
the Act. We believe that the proposed measure's potential to improve
clinical understanding and practice outweighs the minimal burden it
would impose upon facilities. Additionally, we believe that this
measure will provide data that is currently unavailable through Form
2728 because the measure accounts for the most recent information about
patient risk factors, which may change over time as a patient continues
receiving dialysis.
For this proposed reporting measure, we are proposing each facility
will annually update in CROWNWeb up to 24 comorbidities, or indicate
``none of the above,'' for each qualifying case. For the purposes of
this measure, we are proposing to define a ``qualifying case'' as a
hemodialysis or peritoneal dialysis patient being treated at the
facility as of December 31 of the performance period, according to
admit and discharge dates entered into CROWNWeb. In fulfilling this
reporting requirement, facilities would select one or more of the
following for each qualifying case:
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Congestive heart failure. Diabetes, on oral Drug dependence.
medications.
Atherosclerotic heart Diabetes, without Inability to ambulate.
disease (ASHD). medications.
Other cardiac disease. Diabetic retinopathy. Inability to transfer.
Cerebrovascular disease Chronic obstructive Needs assistance with daily
(CVA, TIA). pulmonary disease. activities.
Peripheral vascular Tobacco use (current Institutionalization--
disease. smoker). Assisted Living.
History of hypertension. Malignant neoplasm, Cancer. Institutionalization--
Nursing Home.
Amputation. Toxic nephropathy. Institutionalization--Other
Institution.
Diabetes, currently on Alcohol dependence. Non-renal congenital
insulin. abnormality.
None of the above. .................................... ....................................
----------------------------------------------------------------------------------------------------------------
Therefore, to receive full points on this measure, we are proposing
that facilities would be required to provide the updates in CROWNWeb by
January 31, 2015 or, if that is not a regular business day, the first
business day thereafter. While we are proposing to require facilities
to report a single annual update per patient, we encourage facilities
to update this information more frequently, in order to more closely
monitor their patients' risk factors, and to improve the quality of the
data.
Technical specifications for this proposed measure can be found at
https://www.dialysisreports.org/pdf/esrd/public-measures/ComorbidityReporting-2016NPRM.pdf. We welcome comments on these
proposals.
4. Other Measures Under Development
As part of our effort to continuously improve the ESRD QIP, we
continue to work on developing additional robust measures that provide
valid assessments of the quality of care furnished by facilities to
patients with ESRD. We are considering the feasibility of developing
quality measures in other topic areas (for example, blood transfusions,
kidney transplantation, quality of life, and health information
technology) for quality improvement at the point of care as well as for
the electronic exchange of information in support of care coordination
across providers and settings. Additional areas of potential interest
include residual renal function, complications associated with ESRD,
and frequently comorbid conditions (for example, diabetes and heart
disease). We request comment on these potential areas of future
measurement, and welcome suggestions on other topics for measure
development.
5. Proposed Scoring for the PY 2016 ESRD QIP and Future Payment Years
Section 1881(h)(3)(A)(i) of the Act requires the Secretary to
develop a methodology for assessing the total performance of each
facility based on the performance standards established with respect to
the measures selected for the performance period. We believe that the
methodology set forth in the CY 2013 ESRD PPS final rule incentivizes
facilities to meet the goals of the ESRD QIP; therefore, with the
exception of the proposed changes further discussed in the applicable
section below, we are proposing to adopt a scoring methodology for the
PY 2016 ESRD QIP and future payment years that is nearly identical to
the one finalized in the CY 2013 ESRD PPS final rule. To the extent
that the scoring methodology differs, those differences are proposed
below.
6. Proposed Performance Period for the PY 2016 ESRD QIP
Section 1881(h)(4)(D) of the Act requires the Secretary to
establish the performance period with respect to a year, and that the
performance period occur prior to the beginning of such year. In the CY
2013 ESRD PPS final rule, we finalized a performance period of CY 2013.
We stated our belief that, for most measures, a 12-month performance
[[Page 40863]]
period is the most appropriate for the program because this period
accounts for any potential seasonal variations that might affect a
facility's score on some of the measures, and also provides adequate
incentive and feedback for facilities and Medicare beneficiaries. For
the reasons outlined in the CY 2013 ESRD PPS final rule (77 FR 67500),
we have determined for PY 2016 that CY 2014 is the latest period of
time during which we can collect a full 12 months of data and still
implement the payment reductions beginning with renal dialysis services
furnished on January 1, 2016. Therefore, for the PY 2016 ESRD QIP, we
are proposing to establish CY 2014 as the performance period for all of
the measures. We welcome comments on this proposal.
7. Proposed Performance Standards for the PY 2016 ESRD QIP and Future
Payment Years
We are proposing to adopt performance standards for the PY 2016
ESRD QIP measures that are similar to what we finalized in the CY 2013
ESRD PPS final rule. Section 1881(h)(4)(A) provides that ``the
Secretary shall establish performance standards with respect to
measures selected . . . for a performance period with respect to a
year.'' Section 1881(h)(4)(B) of the Act further provides that the
``performance standards . . . shall include levels of achievement and
improvement, as determined appropriate by the Secretary.'' We use the
performance standards to establish the minimum score a facility must
achieve to avoid a Medicare payment reduction.
a. Proposed Clinical Measure Performance Standards
For the same reasons stated in the CY 2013 ESRD PPS final rule (77
FR 67500 through 76502), we are proposing for PY 2016 to set the
performance standards (both achievement and improvement) based on the
national performance rate (that is, the 50th percentile) of facility
performance in CY 2012, except as specified below.
With respect to the proposed NHSN Bloodstream Infection in
Hemodialysis Outpatients clinical measure, we are proposing to begin
data collection beginning with CY 2014 events. We do not have data
prior to CY 2014 for purposes of setting a performance standard based
on the national performance rate of facility performance in CY 2012.
For that reason, we are proposing that the performance standard for the
NHSN Bloodstream Infection in Hemodialysis Outpatients clinical measure
for PY 2016 be the 50th percentile of the national performance rate on
the measure during CY 2014. Because we lack the baseline data needed to
calculate an improvement score, we are also proposing that, for PY
2016, facilities be scored only on achievement for this measure, and
not on the basis of improvement. Although we recognize that with other
measures that lacked baseline data we instituted a reporting measure to
ensure that both an achievement and improvement score could be
assessed, we believe that it is appropriate, in this case, to adopt a
clinical measure without the baseline data necessary for an improvement
score. Hospital Acquired Infections (HAIs) are a leading cause of
preventable mortality and morbidity across different settings in the
healthcare sector, including dialysis facilities, costing patient lives
and billions of dollars. CMS has recognized that reducing HAIs is
critically important to the Agency's three main goals of improving
healthcare, improving health, and reducing healthcare costs. Because of
the abnormally great impact HAIs have upon patients and the healthcare
industry, we believe it is important to begin assessing facilities on
the number of these events as soon as possible, rather than on merely
whether they report these events. Additionally, the NHSN measure has
been a reporting measure since PY 2014, which will give facilities two
years to report data before they are scored on the data results. Thus,
although we do not yet have complete baseline data to give improvement
scores in PY 2016, we believe it is appropriate to implement this
measure using only achievement scores because of the urgency in
reducing these events and the time facilities have had to prepare
themselves for such a measure. Finally, we are proposing that
facilities would receive a score of zero on the NHSN clinical measure
if they do not submit 12 months of data, as defined in Section
III.C.3.d above, and by the deadlines specified in Section III.C.3.d
above.
For the proposed Patient Informed Consent for Anemia Treatment, we
believe that facilities should meet the standard 100 percent of the
time. However, we recognize that unexpected events might make a 100
percent standard difficult to meet, so we are proposing that facilities
should be allowed to meet the standard for less than 100 percent of
their patients. Because prior data are unavailable for the
establishment of a performance standard, benchmark, and achievement
threshold, we developed a methodology to determine appropriate
achievement standards. As described in Section III.C.10, we are
proposing that a small facility adjuster will be applied to facilities
with between 11 and 25 qualifying patients. Since facilities with
between 11 and 25 patients would be subject to the favorable scoring
modifications applied by the small facility adjuster, these facilities
would have an easier time achieving the proposed achievement standards.
Therefore, the minimum number of cases a facility may have and not
benefit from a small facility adjuster is 26. We calculated that if a
facility with 26 cases failed to obtain consent for two qualifying
cases, it would have obtained consent 92 percent of the time (rounded).
If the facility failed to obtain consent for one case, it would have
obtained consent 96 percent of the time (rounded). We believe that
these values (92 and 96 percent) encourage a high consistency of care
for patients with ESRD that is reasonably attainable by all facilities,
while accounting for the possibility that facilities would be unable to
obtain informed consent for reasons beyond their control. Therefore, we
are proposing that the achievement threshold be defined as obtaining
informed consent for 92 percent of qualifying cases during the
performance period, and that the benchmark be defined as obtaining
informed consent for 96 percent of such cases. Furthermore, we propose
to calculate the proposed performance standard using the average of the
benchmark and achievement threshold, which is 94 percent. We seek
comments on this performance standard.
Because we lack the baseline data needed to calculate improvement
scores for the Patient Informed Consent for Anemia Treatment measure,
we are also proposing that for PY 2016, facilities be scored only on
achievement for this measure, and not on the basis of improvement. We
recognize that with other measures that lacked baseline data we adopted
a reporting measure to ensure that both an achievement and improvement
score could be assessed. However, we believe that it is appropriate, in
this case, to adopt a clinical measure without the baseline data
necessary for an improvement score. Anemia management is a topic
highlighted in the ESRD QIP authorizing statute, requiring measures
that reflect labeling approved by the Food and Drug Administration.
(See section 1881(h)(2)(A) of the Act.) The inclusion of the topic in
statue highlights its importance to CMS and to dialysis patients. ESA
labeling has changed over time as additional safety information
[[Page 40864]]
has become available, and the informed consent process is designed to
ensure that the most current safety information is communicated to
patients before ESAs are administered. In addition, obtaining informed
consent for anemia treatment is a standard of practice that should
aready be in place at dialysis facilities, so facilities should already
have procedures in place to support the measure. Thus, although we do
not yet have complete baseline data to give improvement scores in PY
2016, we believe it is appropriate to implement this measure using only
achievement scores because of the importance of providing patients with
current information about the risks and benefits of anemia therapy, and
because this is already a standard clinical practice.
For the proposed Hypercalcemia measure, the first month that we can
use to establish the baseline is May 2012. This is because the
hypercalcemia measure relies on CROWNWeb as its data source, CROWNWeb
was first rolled out nationally in May 2012, and data submitted to
CROWNWeb before that time is considered test or pilot data. For that
reason, we are proposing to set the performance standard as the 50th
percentile of national performance from May 2012 through November 2012.
We seek comment on this proposal.
b. Estimated Performance Standards for Proposed Clinical Measures
At this time, we do not have the necessary data to assign numerical
values to the proposed performance standards for the clinical measures,
because we do not yet have all of the data from CY 2012 or the first
portion of CY 2013. However, we are able to estimate these numerical
values based on the most recent data available. For all of the proposed
clinical measures except Hypercalcemia, this data comes from the period
of January through November 2012. For the Hypercalcemia clinical
measure, the most recent data available comes from the period May
through November 2012. In Table 8, we have provided the estimated
performance standards for all of the measures except for the NHSN
Bloodstream Infection in Hemodialysis Outpatients clinical measure,
which will be based on data from CY 2014. We will publish updated
values for all measures except the NHSN Bloodstream Infection in
Hemodialysis Outpatients clinical measure in the CY 2014 ESRD PPS final
rule.
Table 8--Estimated Numerical Values for the Performance Standards for
the PY 2016 ESRD QIP Clinical Measures Using the Most Recently Available
Data
------------------------------------------------------------------------
Measure Performance standard
------------------------------------------------------------------------
Vascular Access Type:
%Fistula................................ 62.4%.
%Catheter............................... 10.5%.
Kt/V:
Adult Hemodialysis...................... 93.6%.
Adult, Peritoneal Dialysis.............. 85.4%.
Pediatric Hemodialysis.................. 92.5%.
Anemia Management:
Hemoglobin > 12 g/dL.................... 0%.
Patient Informed Consent for Anemia 94%.
Treatment \1\.
Hypercalcemia............................. 2.3%.
NHSN Bloodstream Infection in Hemodialysis 50th percentile of eligible
Outpatients. facilities' performance
during the performance
period.
------------------------------------------------------------------------
\1\ As noted above, the performance standard for the Patient Informed
Consent for Anemia Treatment is based on clinical standards, not data
collected through the ESRD QIP.
We believe that the ESRD QIP should not have lower standards than
in previous years. In accordance with our statements in the CY 2012
ESRD PPS final rule (76 FR 70273), if the final numerical values for
the PY 2016 performance standards are worse than PY 2015 for a measure,
then we are proposing to substitute the PY 2015 performance standard
for that measure. We request comments on this proposal.
c. Proposed Performance Standards for Reporting Measures
For the proposed ICH CAHPS reporting measure, we are proposing to
set the performance standard for PY 2016 as the facility's successful
submission, by January 28, 2015, of ICH CAHPS survey data collected
during the performance period in accordance with the measure
specifications to CMS as specified at https://ichcahps.org. For PY 2017
and future payment years, we are proposing that the PY 2016 performance
standard continue, except that in each performance period, facilities
are required to submit data from the two surveys conducted during the
performance period, rather than one, and that the survey data must be
submitted by the dates specified by CMS at https://ichcahps.org.
For the proposed Mineral Metabolism reporting measure, we are
proposing to set the performance standard as successfully reporting the
measure for the number of qualifying cases specified in Section
III.C.2.b for each month of the 12-month duration of the performance
period.
For the proposed Anemia Management reporting measure, we are
proposing to set the performance standard as successfully reporting the
measure for the number of qualifying cases specified in Section
III.C.2.c for each month of the 12-month duration of the performance
period.
For the proposed Anemia Management: Pediatric Iron Therapy
reporting measure, we are proposing to set the performance standard as
successfully reporting for each qualifying case each quarter the
following: (i) Patient admit/discharge date; (ii) hemoglobin levels;
(iii) serum ferritin levels; (iv) TSAT percentages; (v) the dates that
the lab measurements were taken for items (ii)-(iv); (vi) intravenous
IV iron prescribed or oral iron prescribed (if applicable); and (vii)
the date that the IV iron or oral iron was prescribed (if applicable).
For the proposed Comorbidity reporting measure, we are proposing to
set the performance standard as successfully updating in CROWNWeb at
least once during the performance period for each qualifying case, the
patient's comorbidities. We are further proposing that the update be
entered into CROWNWeb by the January 31 following the conclusion of the
performance period or, if that is not a regular business day, the first
business day thereafter.
8. Proposed Scoring for the PY 2016 ESRD QIP Proposed Measures
In order to assess whether a facility has met the performance
standards, we finalized a methodology for the PY 2014 ESRD QIP under
which we separately score each clinical and reporting measure. We score
facilities based on an achievement and improvement scoring methodology
for purposes of assessing their performance on the clinical measures
(76 FR 70272 through 70273). We are proposing to use a similar
methodology for purposes of scoring facility performance on each of the
clinical measures for the PY 2016 ESRD QIP and future payment years,
except that we are proposing that there will only be an achievement
score for the NHSN Bloodstream Infection in Hemodialysis Outpatients
and Patient Informed Consent for Anemia Treatment clinical measures,
because data are not available to calculate an improvement score.
In determining a facility's achievement score for the PY 2016
[[Page 40865]]
program and future payment years, we are proposing to continue using
the current methodology described above, under which facilities would
receive points along an achievement range based on their performance
during the proposed performance period for each measure, which we
define as a scale between the achievement threshold and the benchmark
explained below. We are proposing to define the achievement threshold
for each of the proposed clinical measures as the 15th percentile of
the national performance rate during CY 2012, except as otherwise
specified below for the NHSN Bloodstream Infection in Hemodialysis
Outpatients clinical measure, the Patient Informed Consent for Anemia
Treatment clinical measure, and Hypercalcemia clinical measure. We
believe that this achievement threshold will provide an incentive for
facilities to continuously improve their performance, while not
reducing incentives to facilities that score at or above the national
performance rate for the clinical measures (77 FR 67503). We are
proposing to define the benchmark as the 90th percentile of the
national performance rate during CY 2012, except as proposed below for
the NHSN Bloodstream Infection in Hemodialysis Outpatients clinical
measure and the Patient Informed Consent for Anemia Treatment clinical
measure, because it represents a demonstrably high but achievable
standard of quality that the high performing facilities reached.
For the proposed NHSN Bloodstream Infection in Hemodialysis
Outpatients clinical measure, we are proposing that the achievement
threshold and benchmark be the 15th and 90th percentiles, respectively,
of national performance during CY 2014.
For the proposed Patient Informed Consent for Anemia Treatment
clinical measure, and for the reasons described in Section III.C.7.a,
we are proposing that the achievement threshold be defined as obtaining
informed consent for 92 percent of qualifying cases during the
performance period, and that the benchmark be defined as obtaining
informed consent for 96 percent of such cases.
For the reasons described above, the first month that we can use to
establish the baseline for the proposed Hypercalcemia measure is May
2012. Therefore, we are proposing to set the achievement threshold as
the 15th percentile of national performance and the benchmark as the
90th percentile of national performance from May 2012 through November
2012. We request comment on these proposals.
With the exception of the NHSN Bloodstream Infection in
Hemodialysis Outpatients clinical measure and the Patient Informed
Consent Anemia Treatment clinical measure, we are proposing that
facilities receive points along an improvement range, defined as a
scale running between the improvement threshold and the benchmark. We
are proposing to define the improvement threshold as the facility's
performance on the measure during CY 2013. The facility's improvement
score would be calculated by comparing its performance on the measure
during CY 2014 (the proposed performance period) to its performance
rate on the measure during CY 2013. Because we lack the baseline data
needed to calculate improvement scores for the NHSN Bloodstream
Infection in Hemodialysis Outpatients clinical measure and the Patient
Informed Consent for Anemia Treatment clinical measure, we are
proposing that facilities will not receive improvement scores for these
measures for PY 2016.
Like the performance standards, we do not have the necessary data
at this time to assign final numerical values to the proposed
achievement thresholds and benchmarks for the clinical measures.
However, we are able to estimate them based on the most recent data
available. For all of the clinical measures except Hypercalcemia and
NHSN Bloodstream Infection in Hemodialysis Outpatients, this data comes
from the period between January 2012 and November 2012. For the
Hypercalcemia clinical measure, the data comes from the period between
May 2012 and November 2012. In Table 9, we have provided the estimated
achievement thresholds and benchmarks for each of the measures except
for NHSN Bloodstream Infection in Hemodialysis Outpatients clinical
measure (which would be based on data from January 1, 2014 through
December 31, 2104) and Patient Informed Consent for Anemia Treatment
(for which the achievement threshold and benchmark are proposed to be
92 percent and 96 percent, respectively).
Table 9--Estimated Proposed Achievement Thresholds and Benchmarks for
the Proposed PY 2016 ESRD QIP Clinical Measures Using the Most Recently
Available Data
------------------------------------------------------------------------
Achievement
Measure threshold Benchmark
------------------------------------------------------------------------
%Fistula........................ 49.8%............. 77.1%.
%Catheter....................... 19.6%............. 3.0%.
Kt/V:
Adult Hemodialysis.......... 85.9%............. 97.5%.
Adult, Peritoneal Dialysis.. 66.7%............. 94.8%.
Pediatric Hemodialysis...... 83.3%............. 98.8%.
Anemia Management:
Hemoglobin > 12 g/dL............ 1.2%.............. 0%.
Patient Informed Consent for 92%............... 96%.
Anemia Treatment \1\.
Hypercalcemia................... 6.1%.............. 0.2%.
NHSN Dialysis Event Reporting 15th percentile of 90th percentile of
and Clinical Bloodstream eligible eligible
Infection. facilities' facilities'
performance performance
during the during the
performance performance
period. period.
------------------------------------------------------------------------
\1\ As discussed above, the proposed achievement threshold and benchmark
for the Patient Informed Consent for Anemia Treatment clinical measure
are based on clinical standards, not baseline data.
We believe that the ESRD QIP should not have lower standards than
previous years. In accordance with our statements in the CY 2012 ESRD
PPS final rule (76 FR 70273), if the final PY 2016 numerical values for
the achievement thresholds and benchmarks are worse than PY 2015 for a
given measure, we are proposing to substitute the PY 2015 achievement
thresholds and benchmarks for that measure. We request comments on
these proposals.
[[Page 40866]]
a. Proposals for Scoring Facility Performance on Clinical Measures
Based on Achievement
Using the same methodology we finalized in the CY 2013 ESRD PPS
final rule, we are proposing to award between 0 and 10 points for each
of the proposed clinical measures (77 FR 67504). As noted, we are
proposing that the score for each of these clinical measures will be
based upon the higher of an achievement or improvement score on each of
the clinical measures, except for NHSN Bloodstream Infection in
Hemodialysis Outpatients clinical measure and the Patient Informed
Consent for Anemia Treatment clinical measure, which we are proposing
to score on achievement alone. For purposes of calculating achievement
scores for the clinical measures, we are proposing to base the score on
where a facility's performance rate falls relative to the achievement
threshold and the benchmark for that measure. (Performance standards do
not enter into the calculation of improvement or achievement scores.)
Identical to what we finalized in the CY 2013 ESRD PPS final rule, we
are proposing that if a facility's performance rate during the
performance period is:
Equal to or greater than the benchmark, then the facility
would receive 10 points for achievement;
Less than the achievement threshold, then the facility
would receive 0 points for achievement; or
Equal to or greater than the achievement threshold, but
below the benchmark, then the following formula would be used to derive
the achievement score:
[9 * ((Facility's performance period rate - achievement threshold)/
(benchmark - achievement threshold))] + .5, with all scores rounded to
the nearest integer, with half rounded up.
Using this formula, a facility would receive a score of 1 to 9 points
for a clinical measure based on a linear scale distributing all points
proportionately between the achievement threshold and the benchmark, so
that the interval in the performance between the score for a given
number of achievement points and one additional achievement point is
the same throughout the range of performance from the achievement
threshold to the benchmark.
b. Proposals for Scoring Facility Performance on Clinical Measures
Based on Improvement
Using the same methodology we have previously finalized for the
ESRD QIP, we are proposing that facilities would earn between 0 and 9
points for each of the clinical measures that will have an improvement
score (that is, all clinical measures except NHSN Bloodstream Infection
in Hemodialysis Outpatients clinical measure and Patient Informed
Consent for Anemia Treatment), based on how much their performance on
the measure during CY 2014 improved from their performance on the
measure during CY 2013 (77 FR 67504). A specific improvement range for
each measure would be established for each facility. We are proposing
that if a facility's performance rate on a measure during the
performance period is:
Less than the improvement threshold, then the facility
would receive 0 points for improvement; or
Equal to or greater than the improvement threshold, but
below the benchmark, then the following formula would be used to derive
the improvement score:
[10 * ((Facility performance period rate - Improvement threshold)/
(Benchmark - Improvement threshold))] - .5, with all scores rounded to
the nearest integer, with half rounded up.
Note that if the facility score is equal to or greater than the
benchmark, then it would receive 10 points on the measure based on the
achievement score methodology discussed above. We request comments on
this proposal.
c. Proposals for Calculating Facility Performance on Reporting Measures
As noted above, reporting measures differ from clinical measures in
that they are not scored based on clinical values; rather, they are
scored based on whether facilities are successful in achieving the
reporting requirements associated with each of these proposed measures.
The proposed criteria that would apply to each reporting measure are
discussed below.
With respect to the proposed Anemia Management reporting measure
and the proposed Mineral Metabolism reporting measure, we are proposing
to award points to facilities using the same formula that we finalized
in the CY 2013 ESRD PPS final rule for Mineral Metabolism and Anemia
Management (77 FR 67506):
[GRAPHIC] [TIFF OMITTED] TP08JY13.000
With respect to the proposed Use of Iron Therapy for Pediatric
Patients reporting measure, using the following formula:
[GRAPHIC] [TIFF OMITTED] TP08JY13.001
We are proposing to score the Pediatric Iron Therapy measure
differently than the proposed Anemia Management reporting measure and
the proposed Mineral Metabolism reporting measure because it requires
quarterly rather than monthly reporting, and therefore scoring based on
monthly reporting rates is not feasible.
With respect to the proposed ICH CAHPS reporting measure and
Comorbidity reporting measure, we are proposing that a facility receive
a score of 10 points if it satisfies the performance standard for the
measure, and 0 points if it does not. We are proposing to score these
reporting measures differently than the other reporting measures
because these require annual or biannual reporting, and therefore
scoring based on monthly or quarterly reporting rates is not feasible.
We request comment on the proposed methodology for scoring the PY
2016 ESRD QIP reporting measures.
[[Page 40867]]
9. Proposals for Weighting the PY 2016 ESRD QIP Measures and
Calculating the PY 2016 ESRD QIP Total Performance Score
Section 1881(h)(3)(A)(iii) of the Act provides that the methodology
for calculating the facility TPS shall include a process to weight the
performance scores with respect to individual measures to reflect
priorities for quality improvement, such as weighting scores to ensure
that facilities have strong incentives to meet or exceed anemia
management and dialysis adequacy performance standards, as determined
appropriate by the Secretary. In determining how to appropriately
weight the PY 2016 ESRD QIP measures for purposes of calculating the
TPS, we considered two criteria: (1) The number of measures we are
proposing to include in the PY 2016 ESRD QIP; and (2) the National
Quality Strategy priorities.
a. Weighting Individual Measures To Compute Measure Topic Scores for
the Kt/V Dialysis Adequacy Measure Topic, the Vascular Access Type
Measure Topic, and the Anemia Management Clinical Measure Topic
In the CY 2013 ESRD PPS final rule, we established a methodology
for deriving the overall scores for measure topics (77 FR 67507). For
the reasons described in the CY 2013 ESRD PPS final rule, we are
proposing to use the same methodology in PY 2016 and future payment
years to calculate the scores for the three measure topics. After
calculating the individual measure scores within a measure topic, we
are proposing to calculate a measure topic score using the following
steps: (i) Dividing the number of patients in the denominator of each
measure by the sum of the number of patients in each denominator for
all of the applicable measures in the measure topic; (ii) multiplying
that figure by the facility's score on the measure; (iii) summing the
results achieved for each measure; and (iv) rounding this sum (with
half rounded up). We are proposing that if a facility does not have
enough patients to receive a score on one of the measures in the
measure topic (as discussed below), then that measure would not be
included in the measure topic score for that facility. Only one measure
within the measure topic needs to have enough cases to be scored in
order for the measure topic to be scored and included in the
calculation of the TPS. We are also proposing that the measure topic
score would be equal to one clinical measure in the calculation of the
TPS. For an additional explanation, see the examples provided at 77 FR
67507.
We request comment on the proposed method of weighting individual
measure scores to derive a measure topic score.
b. Proposal for Weighting the Total Performance Score
We continue to believe that weighting the clinical measures/measure
topics equally will incentivize facilities to improve and achieve high
levels of performance across all of these measures, resulting in
overall improvement in the quality of care provided to patients with
ESRD. We also continue to believe that, while the reporting measures
are valuable, the clinical measures evaluate actual patient outcomes
and therefore justify a higher combined weight (77 FR 67506 through
67508). For the reasons outlined in the CY 2013 ESRD PPS final rule, we
are proposing to continue weighting clinical measures as 75 percent and
reporting measures as 25 percent of the TPS. We request comment on this
proposed methodology for weighting the clinical and reporting measures.
We have also considered the issue of awarding a TPS to facilities
that do not report data on the proposed minimum number of cases with
respect to one or more of the measures or measure topics. For the
reasons stated in the CY 2013 ESRD PPS final rule, for PY 2016 and
future payment years, we are proposing to continue to require a
facility to have at least one clinical and one reporting measure score
to receive a TPS (77 FR 67508). We request comment on our proposals to
require a facility to be eligible for a score on at least one reporting
and one clinical measure in order to receive a TPS.
Finally, we are proposing that the TPSs be rounded to the nearest
integer, with half of an integer being rounded up. We request comment
on this proposal. For further examples regarding measure and TPS
calculations, we refer readers to the figures below.
c. Examples of the Proposed PY 2016 ESRD QIP Scoring Methodology
In this section, we provide examples to illustrate the proposed
scoring methodology for PY 2016. Figures 1-3 illustrate the scoring for
a clinical measure. Figure 1 shows Facility A's performance on an
example clinical measure. Note that for this example clinical measure,
the facility has performed very well. The example benchmark (the 90th
percentile of performance nationally in CY 2012) calculated for this
clinical measure is 77 percent, and the example achievement threshold
(which is the 15th percentile of performance nationally in CY 2012) is
46 percent. Therefore, facility A's performance of 86 percent on the
clinical measure during the performance period exceeds the benchmark of
77 percent, so Facility A would earn 10 points (the maximum) for
achievement for this measure. (Because, in this example, Facility A has
earned the maximum number of points possible for this measure, its
improvement score is irrelevant.)
[[Page 40868]]
[GRAPHIC] [TIFF OMITTED] TP08JY13.002
Figure 2 shows an example of scoring for another facility, Facility
B. As illustrated below, the facility's performance on the example
clinical measure improved from 26 percent in CY 2013 to 54 percent
during the performance period. The achievement threshold is 50 percent
and the achievement benchmark is 77 percent. Because the facility's
performance during the performance period is within the achievement
range and the improvement range, we must calculate the improvement and
achievement scores to determine the example clinical measure score.
To calculate the achievement score, we would apply the formula
discussed above. The result of this formula for this example is [9 *
((54-50)/(77-50))] + .5, which equals 1.83, and we round to the nearest
integer, which is 2.
Likewise, to calculate the improvement score, we apply the
improvement formula discussed above. The result of this formula for
this is example is [10 * ((54-26)/(77-26))]-.5, which equals 4.99 and
we round to the nearest integer, which is 5.
Therefore, for this example clinical measure, Facility B's
achievement score is 3, and its improvement score is 5. We award
Facility B the higher of the two scores for this clinical measure.
Thus, Facility B's score on this example measure is 5.
[[Page 40869]]
[GRAPHIC] [TIFF OMITTED] TP08JY13.003
BILLING CODE 4120-01-P
In Figure 3, Facility C's performance on the example clinical
measure drops from 26 percent in CY 2013 to 23 percent during the
performance period, a decline of 3 percent. Because Facility C's
performance during the performance period falls below the achievement
threshold of 26 percent, it receives 0 points for achievement. Facility
C also receives 0 points for improvement because its performance during
the performance period was lower than its performance during CY 2013.
Therefore, in this example, Facility C would receive 0 points for the
example clinical measure.
[[Page 40870]]
[GRAPHIC] [TIFF OMITTED] TP08JY13.004
The method illustrated above would be applied to each clinical
measure in order to obtain a score for each measure. Scores for
reporting measures are calculated based upon their individual criteria,
as discussed earlier.
After calculating the scores for each measure, we would calculate
the TPS. As an example, by applying the weighting criteria to a
facility that receives a score on all finalized measures, we would
calculate the facility's TPS using the following formula:
Total Performance Score = [(.150 * Vascular Access Type Measure Topic)
+ (.150 * Kt/V Dialysis Adequacy Measure Topic) + (.150 * Anemia
Management Clinical Measure Topic) + (.150 * Hypercalcemia Measure) +
(.150 * NHSN Bloodstream Infection in Hemodialysis Outpatients) + (.05
* ICH CAHPS Survey Reporting Measure) + (.05 * Mineral Metabolism
Reporting Measure) + (.05 * Anemia Management Reporting Measure) + (.05
* Pediatric Iron Therapy Reporting Measure) + (.05 * Comorbidity
Reporting Measure) ] * 10.
The TPS would be rounded to the nearest integer (and any individual
measure values ending in .5 would be rounded to the next higher
integer).
However, if, for example, a facility did not receive a score (that
is, did not have enough qualifying cases) on the proposed Hypercalcemia
measure, then the facility's TPS would be calculated as follows:
Total Performance Score = [(.188 * Vascular Access Type Measure Topic)
+ (.188 * Kt/V Dialysis Adequacy Measure Topic) + (.188 * Anemia
Management Clinical Measure Topic) + (.188 * NHSN Bloodstream Infection
in Hemodialysis Outpatients) + (.05 * ICH CAHPS Survey Reporting
Measure) + (.05 * Mineral Metabolism Reporting Measure) + (.05 * Anemia
Management Reporting Measure) + (.05 * Pediatric Iron Therapy Reporting
Measure) + (.05 * Comorbidity Reporting Measure) ] * 10.
Again, the TPS would be rounded to the nearest integer (and any
individual measure values ending in .5 would be rounded to the next
higher integer).
Finally, for example, if a facility is eligible for only two of the
reporting measures, then the facility's TPS would be calculated as
follows:
Total Performance Score = [(.150 * Vascular Access Type Measure Topic)
+ (.150 * Kt/V Dialysis Adequacy Measure Topic) + (.150 * Anemia
Management Cinical Measure Topic) + (.150 * Hypercalcemia Measure) +
(.150 * NHSN Bloodstream Infection in Hemodialysis Outpatients) + (.125
* Anemia Management Reporting Measure) + (.125 * Comorbidity Reporting
Measure)] * 10.
Again, the TPS would be rounded to the nearest integer (and any
individual measure values ending in .5 would be rounded to the next
higher integer).
10. Proposed Minimum Data for Scoring Measures for the PY 2016 ESRD QIP
and Future Payment Years
For the same reasons described in the CY 2013 ESRD PPS final rule
(77 FR 67510 through 67512), for PY 2016 and future payment years, we
are proposing to only score facilities on clinical and reporting
measures for which they have a minimum number of qualifying cases
during the performance period. For PY 2016 and future payment years, we
are proposing that a facility must have a threshold of at least 11
qualifying cases for the entire performance period in order to be
scored on a clinical measure. We are proposing that reporting measures
other than ICH CAHPS will have a threshold of one qualifying case
during the performance period. The 11-qualifying case minimum was
intended to reduce burden on facilities with limited qualifying cases
for earlier
[[Page 40871]]
reporting measures (77 FR 67480, 67483, 67486 and 67493). We are
proposing to set the reporting measure case minimums at one because we
plan to use data to permit future implementation of clinical measures.
If patients in small facilities are systematically excluded, then we
will not be able to gather the robust data we need to support the
performance standard, benchmark, and achievement threshold calculations
in future payment years. For example, if we excluded facilities with 10
or fewer patients from the Pediatric Iron Therapy reporting measure,
then very few, if any, facilities would be able to report the measure,
and we would be unable to collect meaningful data for future measure
development. Similarly, if we excluded facilities with 10 or fewer
patients from the comorbidity reporting measure, then we would be
unable to use updated comorbidities for patients in these facilities in
a risk-adjusment calculation should we propose to adopt an SHR and/or
SMR clinical measure in the future. For those reasons, we are proposing
that the case minimum for all reporting measures except for ICH CAHPS
be one.
For the proposed expanded ICH CAHPS reporting measure, we are
proposing that facilities with fewer than 30 qualifying cases during
the performance period not be scored on the measure. In the CY 2013
ESRD PPS final rule, we excluded facilities with 10 or fewer adult in-
center hemodialysis patients from the ICH CAHPS measure because we
recognized that, for many small dialysis facilities, hiring a third-
party administrator to fulfill the ICH CAHPS survey requirements would
have been impractical or prohibitively costly (77 FR 67480). As we move
toward developing a clinical measure, we have determined that the
survey results are more reliable if there are at least 30 surveys
submitted per facility. Therefore, we are proposing that for PY 2016
and future payment years, facilities that treat fewer than 30
qualifying cases (defined as adult in-center hemodialysis patients)
during the performance period will be excluded from this measure. We
further are proposing that we will consider a facility to have met the
30-patient threshold unless it affirmatively attests in CROWNWeb by
January 31 of the year prior to the year in which payment reductions
will be made (for example, January 31, 2015, for the PY 2016 ESRD QIP)
that it treated 29 or fewer adult in-center hemodialysis patients
during the performance period.
For the same reasons described in the CY 2013 ESRD PPS final rule
(77 FR 67510 through 67512), for PY 2016 and future payment years, we
are proposing to apply to each clinical measure score for which a
facility has between 11 and 25 qualifying cases the same adjustment
factor we finalized in the CY 2013 ESRD PPS final rule (77 FR 67511).
We seek public comment on these proposals.
For the PY 2016 ESRD QIP and future payment years, we are also
proposing to continue to begin counting the number of months or
quarters, as applicable, for which a facility is open on the first day
of the month after the facility's CCN open date. With the exception of
the ICH CAHPS expanded reporting measure, we are proposing that only
facilities with a CCN open date before July 1, 2014, be scored on the
proposed reporting measures. Under the specifications for the proposed
ICH CAHPS reporting measure, facilities would need to administer the
survey (via a CMS-approved, third-party vendor) during the performance
period. Because arranging such an agreement takes time, we are
proposing that only facilities with a CCN open date before January 1 of
the performance period to be scored on this measure. Additionally, we
are proposing that facilities with CCN open dates after January 1, 2014
will not be scored on the NHSN. We note that in previous payment years
we have awarded partial credit to facilities that submitted less than
12 months of data to encourage them to enroll in and report data in the
NHSN system. However, we are proposing to collect 12 months of data on
this clinical measure because infection rates vary through different
seasons of the year.
As discussed above, we are proposing that a facility will not
receive a TPS unless it receives a score on at least one clinical and
one reporting measure. We note that finalizing this proposal would
result in facilities not being eligible for a payment reduction for the
PY 2016 ESRD QIP and future payment years if they have a CCN open date
on or after July 1 of the performance period (CY 2014 for the PY 2016
ESRD QIP). We request comment regarding these proposals.
11. Proposed Payment Reductions for the PY 2016 ESRD QIP and Future
Payment Years
Section 1881(h)(3)(A)(ii) of the Act requires the Secretary to
ensure that the application of the scoring methodology results in an
appropriate distribution of payment reductions across facilities, such
that facilities achieving the lowest TPSs receive the largest payment
reductions. For PY 2016, we are proposing that a facility would not
receive a payment reduction if it achieves a minimum TPS that is equal
to or greater than the total of the points it would have received if:
(i) It performed at the performance standard for each clinical measure;
(ii) it received zero points for each clinical measure that did not
have a numerical value for the performance standard published with the
PY 2016 final rule; and (iii) it received five points for each
reporting measure. We request comments on these proposals.
Section 1881(h)(3)(A)(ii) of the Act requires that facilities
achieving the lowest TPSs receive the largest payment reductions. For
PY 2016 and future payment years, we are proposing that the payment
reduction scale be the same as the PY 2015 ESRD QIP (77 FR 67514
through 67516). We are proposing that, for each 10 points a facility
falls below the minimum TPS, the facility would receive an additional
0.5 percent reduction on its ESRD PPS payments for PY 2016 and future
payment years, with a maximum reduction of 2.0 percent. As we stated in
the CY 2012 ESRD PPS final rule, we believe that such a sliding scale
will incentivize facilities to meet the performance standards
established and continue to improve their performance; even if a
facility fails to achieve the minimum TPS, such a facility will still
be incentivized to strive for and attain better performance rates in
order to reduce the percentage of its payment reduction (76 FR 70281).
We request comments on the proposed payment reduction scale.
Because we are not yet able to calculate the performance standards
for each of the clinical measures, we are also not able to calculate
the minimum TPS at this time. Based on the estimated performance
standards listed above using the most recent data available, we
estimate for PY 2016 that a facility must meet or exceed a minimum TPS
of 46. For all of the clinical measures except Hypercalcemia, this data
comes from the period between January 2012 and November 2012. For the
Hypercalcemia clinical measure, the data comes from the period between
May 2012 and November 2012. We are proposing that facilities failing to
meet the minimum TPS (as will be published in the Medicare Program;
End-Stage Renal Disease Prospective Payment System, Quality Incentive
Program, and Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies final rule in November) will receive payment reductions based
on the estimated total performance score ranges indicated in Table 10
below.
[[Page 40872]]
Table 10--Estimated Payment Reduction Scale for PY 2016 based on the
Most Recently Available Data
------------------------------------------------------------------------
Reduction
Total performance score (Percent)
------------------------------------------------------------------------
100-46 *................................................ 0
45-36................................................... 0.5
35-26................................................... 1.0
25-16................................................... 1.5
15-0.................................................... 2.0
------------------------------------------------------------------------
12. Data Validation
One of the critical elements of the ESRD QIP's success is ensuring
that the data submitted to calculate measure scores and TPSs are
accurate. We began a pilot data-validation program in CY 2013 for the
ESRD QIP, and we are now in the process of procuring the services of a
data-validation contractor, who will be tasked with validating a
national sample of facilities' records as they report CY 2013 data to
CROWNWeb. The first priority will be to develop a methodology for
validating data submitted to CROWNWeb under the pilot data-validation
program; once this methodology has been developed, CMS will publicize
it through a CROWN Memo and solicit public comment. As part of the CY
2013 ESRD QIP PPS final rule (77 FR 67522 through 67523), we finalized
a requirement to sample approximately 10 records from 750 randomly
selected facilities; these facilities will have 60 days to comply once
they receive requests for records. We are proposing to extend this
pilot data-validation program to include analysis of data submitted to
CROWNWeb during CY 2014. For the PY 2016 ESRD QIP, sampled facilities
will be reimbursed by our validation contractor for the costs
associated with copying and mailing the requested records.
Additionally, we are proposing to reduce the annual random sample size
from 750 to 300. We believe that this smaller sample size will still
yield a sufficiently precise estimate of QIP reliability while imposing
a smaller burden on ESRD QIP-eligible facilities and CMS alike. We are
also proposing to extend our policy that no facility will receive a
payment reduction resulting from the validation process for CY 2014
during PY 2016. Once we have gathered additional information based on
these initial validation efforts, we will propose further procedures
for validating data submitted in future years of the ESRD QIP. These
procedures may include a method for scoring facilities based on the
accuracy of the data they submit to CROWNWeb, and a method to assign
penalties for submitting inaccurate data. We solicit comments on these
proposals.
We are also considering a feasibility study for validating data
reported to CDC's NHSN Dialysis Event Module, which may mirror the
process used by the Hospital Inpatient Quality Reporting Program (77 FR
53539 through 53553). Although this is still in the early stages of
development, we anticipate that this study may mirror the validation
sample by targeting ``candidate HAI events,'' much like the methodology
used by CMS's Hospital Inpatient Quality Reporting Program. The
feasibility study will likely: (i) Estimate the burden and associated
costs to ESRD QIP-eligible facilities for participating in an NHSN
validation program; (ii) assess the costs to CMS to implement an NHSN
validation program on a statistically relevant scale; and (iii) develop
and test a protocol to validate NHSN data in nine ESRD QIP-eligible
facilities. Facilities would be selected on a voluntary basis. Based on
the results of this study, we intend to propose more detailed
requirements for validating NHSN data used in the ESRD QIP in the
future.
13. Proposals for Scoring Facilities Whose Ownership Has Changed
During PY 2012 (our first implementation year for the ESRD QIP),
facilities requested guidance regarding how a change in ownership
affects any applicable ESRD QIP payment reductions. Starting with the
implementation of the PY 2015 ESRD QIP (which is CY 2013), the
application of an ESRD QIP payment reduction depended on whether the
facility retained its CCN after the ownership transfer. If the
facility's CCN remained the same after the facility was transferred,
then we considered the facility to be the same facility (despite the
change in ownership) for the purposes of the ESRD QIP, and we applied
any ESRD QIP payment reductions that would have applied to the
transferor to the transferee. Likewise, as long as the facility
retained the same CCN, we calculated the measure scores using the data
submitted during the applicable period, regardless of whether the
ownership changed during one of these periods. If, however, a facility
received a new CCN as a result of a change in ownership, then we
treated the facility as a new facility for purposes of the ESRD QIP
based on the new facility's CCN open date. We believe that these
proposals are the most operationally efficient and will allow
facilities the greatest amount of certainty when they change ownership.
We are proposing to continue applying these rules during the PY 2016
ESRD QIP and future years of the program, and we request public comment
on this proposal.
14. Proposals for Public Reporting Requirements
Section 1881(h)(6)(A) of the Act requires the Secretary to
establish procedures for making information available to the public
about facility performance under the ESRD QIP, including information on
the TPS (as along with appropriate comparisons of facilities to the
national average with respect to such scores) and scores for individual
measures achieved by each facility. Section 1881(h)(6)(B) of the Act
further requires that a facility have an opportunity to review the
information to be made public with respect to that facility prior to
publication. In addition, section 1881(h)(6)(C) of the Act requires the
Secretary to provide each facility with a certificate containing its
TPS to post in patient areas within the facility. Finally, section
1881(h)(6)(D) of the Act requires the Secretary to post a list of
facilities and performance-score data on a CMS Web site.
In the PY 2012 ESRD QIP final rule, we adopted uniform requirements
based on sections 1881(h)(6)(A) through 1881(h)(6)(D) of the Act,
thereby establishing procedures for facilities to review the
information to be made public and for informing the public through
facility-posted certificates. We are proposing to maintain the public
reporting requirements as finalized in the CY 2013 ESRD PPS final rule,
except regarding the timing of when facilities must post their
certificates.
For PYs prior to PY 2014, we required facilities to post
certificates within 5 business days of us making these certificates
available for download from dialysisreports.org in accordance with
section 1881(h)(6)(C) of the Act. (77 FR 67516 and 76 FR 637) In the CY
2013 ESRD PPS final rule, we noted that many individuals responsible
for posting the certificates were away on holiday during the December
time period when certificates typically become available, and finalized
that, beginning in PY 2014, a facility must post copies of its
certificates by the first business day after January 1 of the payment
year. (77 FR 67517) We also noted that certificates are typically
available for download on or around December 15 of each year, and
stated that we believe that this two week time is enough to allow
facilites to post them.
Since the CY 2013 ESRD PPS final rule was finalized, we have noted
that a posting deadline of the first business day after January 1 could
create
[[Page 40873]]
difficulties for facilities if it were ever the case that certificates
were not available for download in the typical timeframe. We want to
ensure that facilities have adequate time to post certificates as
required in this circumstance, and that the required timing
accommodates the December holidays. Therefore, we propose that,
beginning in PY 2014, facilities must post certificates within fifteen
business days of us making these certificates available for download
from dialysisreports.org in accordance with section 1881(h)(6)(C) of
the Act. We request comments on this proposal.
IV. Clarification of the Definition of Routinely Purchased Durable
Medical Equipment (DME)
A. Background
1. Background for DME
Title XVIII of the Social Security Act (the Act) governs the
administration of the Medicare program. The statute provides coverage
for broad categories of benefits, including, but not limited to,
inpatient and outpatient hospital care, skilled nursing facility care,
home health care, physician services, and DME. ``Medical and other
health services,'' which is defined under section 1861(s)(6) of the Act
to include DME, is a separate Medicare Part B benefit for which payment
is authorized by section 1832 of the Act. In accordance with section
1861(n) of the Act, the term ``durable medical equipment'' includes
iron lungs, oxygen tents, hospital beds, and wheelchairs used in the
beneficiary's home, including an institution used as his or her home
other than an institution that meets the requirements of section
1861(e)(1) or section 1819(a)(1) of the Act.
Section 1834(a) of the Act, as added by section 4062 of the Omnibus
Budget Reconciliation Act of 1987 (OBRA 87), Public Law 100-203, sets
forth the payment rules for DME furnished on or after January 1, 1989.
The Medicare payment amount for a DME item is generally equal to 80
percent of the lesser of the actual charge or the fee schedule amount
for the item, less any unmet Part B deductible. The beneficiary's
coinsurance for such items is generally equal to 20 percent of the
lesser of the actual charge or the fee schedule amount for the item
once the deductible is met. The fee schedule amounts are generally
calculated using average allowed charges from a base period and then
increased by annual update factors. Sections 1834(a)(2) through (a)(7)
of the Act set forth separate classes of DME and separate payment rules
for each class. The six classes of items are: inexpensive and other
routinely purchased DME; items requiring frequent and substantial
servicing; customized items; oxygen and oxygen equipment; other covered
items (other than DME); and other items of DME, also referred to as
capped rental items. The class for inexpensive and other routinely
purchased DME also includes accessories used in conjunction with
nebulizers, aspirators, continuous positive airway pressure devices and
respiratory assist devices. Items of DME fall under the class for other
items of DME (capped rental items) if they do not meet the definitions
established in the statute and regulations for the other classes of
DME.
2. Medicare Guidance and Rulemaking Regarding Definition of Routinely
Purchased DME
On July 14, 1988, CMS central office issued a program memorandum to
the CMS regional offices containing guidance for carriers to follow in
developing a data base that would be used in identifying other
routinely purchased DME for the purpose of implementing section
1834(a)(2)(a)(ii) of the Act. For the purpose of identifying routinely
purchased items, the carriers were instructed via the program
memorandum to ``compute the unduplicated count of beneficiaries who
purchased the item, by HCPCS code, and a count of those who only rented
the item during the 7/1/86-6/30/87 period.'' The carriers were
instructed to include purchase of new and used items and beneficiaries
who purchased an item that was initially rented in the count of
beneficiaries who purchased the item. The carriers made determinations
regarding whether DME furnished during this period would be rented
(non-capped) or purchased based on which payment method was more
economical.
In November 1988, CMS revised Part 3 (Claims Process) of the
Medicare Carriers Manual (HCFA Pub. 14-3) via transmittal number 1279,
by adding section 5102 and detailed instructions for implementation of
the fee schedules and payment classes for DME mandated by section 4062
of OBRA 87. The new implementing instructions were effective for
services furnished on or after January 1, 1989. Section 5102.1
indicated that carriers would be provided with a listing of the HCPCS
(Health Care Financing Administration Common Procedure Coding System
prior to 2003 and Healthcare Common Procedure Coding System beginning
in 2003) codes for the equipment in the routinely purchased DME
category. The initial classifications were implemented on January 1,
1989, in accordance with the program instructions, and included a
listing of HCPCS codes for base equipment such as canes and walkers, as
well as HCPCS codes for replacement accessories such as cane tips,
walker leg extensions, and power wheelchair batteries for use with
medically necessary, patient-owned base equipment (canes, walkers, and
power wheelchairs). In the case of expensive accessories that were not
routinely purchased during July 1986 through June 1987, such as a
wheelchair attachment to convert any wheelchair to one arm drive, these
items fell under the listing of HCPCS codes for capped rental items.
Medicare payment for DME extends to payment for replacement of
essential accessories used with patient-owned equipment or accessories,
attachments, or options that modify base equipment, such as the
addition of elevating leg rests to a manual wheelchair.
The Medicare definition of routinely purchased equipment is under
42 CFR Sec. 414.220(a)(2) and specifies that routinely purchased
equipment means equipment that was acquired by purchase on a national
basis at least 75 percent of the time during the period July 1986
through June 1987.'' This definition was promulgated via an interim
final rule (IFC) on December 7, 1992 (57 FR 57698), remaining
consistent with Medicare program guidance in effect beginning in 1988
and discussed above, and finalized on July 10, 1995 (60 FR 35492). In
the preamble of the 1992 IFC (57 FR 57679), we discussed how items were
classified as routinely purchased DME based on data from July 1986
through June 1987, ``in the absence of a statutory directive that
defines the period for determining which items are routinely
purchased.'' CMS indicated that it ``selected the period July 1, 1986
through June 30, 1987, because it is the same 12-month period required
by section 1834(a)(2)(B)(i) of the Act for calculating the base fee
schedule amount for routinely purchased equipment.'' This period was
therefore established as the period from which data was used for
identifying the items that had been acquired on a purchase basis 75
percent of the time or more under the Medicare rent/purchase program.
3. Payment for Inexpensive or Routinely Purchased Items and Capped
Rental Items
Pursuant to 42 CFR Sec. 414.220(b) payment for inexpensive or
routinely purchased DME is made on a purchase
[[Page 40874]]
or rental basis, with total payments being limited to the purchase fee
schedule amount for the item. If an item is initially rented and then
purchased, the allowed purchase charge is based on the lower of the
actual charge or fee schedule amount for purchase of the item minus the
cumulative allowed charge for previously paid rental claims. Pursuant
to 42 CFR Sec. 414.229(f), payment for capped rental items is made on
a monthly rental basis for up to 13 months of continuous use. The
supplier must transfer title to the equipment to the beneficiary on the
first day following the 13th month of continuous use.
B. Current Issues
Concerns have been raised about the application of the definition
of and payment for routinely purchased DME, as it applies to expensive
DME accessories. For example, recently one manufacturer of a new,
expensive wheelchair accessory, included under a HCPCS code that would
result in a corresponding Medicare fee schedule amount of approximately
$3,000, if purchased, questioned why the HCPCS code describing their
product was classified as capped rental DME. They pointed out that
codes added to the HCPCS in recent years for other similar and more
expensive wheelchair accessories costing $4,000 to $10,000 were
classified as routinely purchased DME even though the items were not
purchased under Medicare during the period specified in Sec.
414.220(b). As a result, we began a review of expensive items that have
been classified as routinely purchased equipment since 1989, that is,
new codes added to the HCPCS after 1989 for items costing more than
$150, to address this apparent inconsistency.
As a result of this review, we found some codes that are not
classified consistent with the regulatory definition of routinely
purchased equipment at section Sec. 414.220(a)(2). We found that HCPCS
codes added after 1989 for expensive, durable accessories used with
base equipment, such as wheelchairs, have been classified as routinely
purchased equipment. While section 1834(a)(2)(A)(iii) of the Act and 42
CFR Sec. 414.220(a)(3) of the regulations allow payment for the
purchase of accessories used in conjunction with nebulizers,
aspirators, continuous positive airway pressure devices (CPAP), other
items covered under the DME benefit including DME other than
nebulizers, aspirators, CPAP devices, respiratory assist devices and
accessories used in conjunction with those items, are paid for in
accordance with the rules at section 1834(a) of the Act and are
classified under sections 1834(a)(3) thru (7) of the Act as inexpensive
and other routinely purchased DME, items requiring frequent and
substantial servicing, certain customized items, oxygen and oxygen
equipment, other covered items other than DME, or other covered items
of DME.
Additionally, we found that in some cases, expensive items of DME
were classified as routinely purchased based on information suggesting
that payers other than Medicare were routinely making payment for the
items on a purchase basis. We believe that classifying an item as
routinely purchased equipment based on data and information from other
payers for the purposes of implementing Sec. 414.220(b) is
inappropriate because other payers do not operate under the same
payment rules as Medicare. Other payers may decide to purchase
expensive items for reasons other than a achieving a more economical
alternative to rental, the basis Medicare contractors used in deciding
whether to purchase items during July 1986 through June 1987. In other
cases, expensive items of DME were classified as routinely purchased
equipment based on requests from manufacturers of equipment primarily
used by Medicaid beneficiaries. We do not believe we should classify an
item as routinely purchased equipment for the purposes of implementing
Sec. 414.220(b) of the Medicare regulations based on how this might
affect other payers such as Medicaid state agencies because such
classifications are not consistent with the regulations, which for
Medicare purposes generally require payment on a capped rental basis
for any item with a purchase cost of greater than 150 dollars. After
reviewing this issue, we do not think the regulation supports the
classification of expensive DME as routinely purchased equipment based
solely on whether other payers routinely pay for the item on a purchase
basis or how manufacturers would prefer that other payers pay for the
item. The classification of HCPCS codes for expensive equipment added
after 1989 as routinely purchased equipment based on this kind of
information does not comply with the Medicare definition of routinely
purchased equipment and defeats a fundamental purpose of the capped
rental payment methodology to avoid paying the full purchase price of
costly equipment used only a short time.
DME and accessories used in conjunction with DME are paid for under
the DME benefit and in accordance with the rules at section 1834(a) of
the Act. We are clarifying the existing definition of routinely
purchased equipment at Sec. 414.220(a)(2) and providing notice that
certain HCPCS codes for DME and DME accessories added to the HCPCS
after 1989 that are currently classified as routinely purchased
equipment should be reclassified as capped rental items (see Table 11
below). This applies to all expensive items for which Medicare claims
data July 1986 through June 1987 does not exist or does not indicate
that the item was acquired by purchase on a national basis at least 75
percent of the time. In the case of expensive accessories that are
furnished for use with complex rehabilitative power wheelchairs, the
purchase option for complex rehabilitative power wheelchairs at section
1834(a)(7)(A)(iii) of the Act would also apply to these accessories.
For any wheelchair accessory classified as a capped rental item and
furnished for use with a complex rehabilitiave power wheelchair (that
is, furnished to be used as part of the complex rehabilitative power
wheelchair), the supplier must give the beneficiary the option of
purchasing these accessories at the time they are furnished. These
items would be considered as part of the complex rehabilitative power
wheelchair and associated purchase option set forth at Sec.
414.229(a)(5).
We are soliciting comments on the effective date(s) for
reclassifying items previously classified as routinely purchased
equipment to the capped rental payment class in order to be in
compliance with current regulations. Given that some items (HCPCS
codes) may be included in the Round 2 and/or Round 1 Recompete phases
of the competitive bidding program, we do not believe we can change the
classification for items furnished under these programs until the
contracts awarded based on these competitions expire on July 1, 2016,
and January 1, 2017, respectively, regardless of whether the item is
provided in an area subject to competitive bidding or not. We propose
that the reclassification of items previously classified as routinely
purchased equipment to the capped rental payment class be effective
January 1, 2014, for all items that are not included in either a Round
2 or Round 1 Recompete competitive bidding program (CBP) established in
accordance with Sec. 414.400. For any item currently under a Round 2
CBP, instead of a January 1, 2014, effective date we propose July 1,
2016, for these reclassifications, which would apply to all items
furnished in all areas of the
[[Page 40875]]
country, with the exception of items furnished in a Round 1 Recompete
CBP. For items furnished in a Round 1 Recompete CBP, we propose an
effective date of January 1, 2017, which would only apply to items
furnished in the nine Round 1 Recompete areas. Therefore, we propose to
generally base the effect dates on when the competitive bidding
programs end. To summarize, the proposed effective dates for the
reclassifications of these items from the routinely purchased DME class
to the capped rental DME class would be:
January 1, 2014, for items furnished in all areas of the
country if the item is not included in Round 2 or Round 1 Recompete
CBP;
July 1, 2016, for items furnished in all areas of the
country if the item is included in a Round 2 CBP and not a Round 1
Recompete CBP and for items included in a Round 1 Recompete CBP but
furnished in an area other than one of the 9 Round 1 Recompete areas;
and
January 1, 2017, for items included in a Round 1 Recompete
CBP and furnished in one of the nine Round 1 Recompete areas.
With the exception of the items described in the fourth bullet,
this implementation strategy would allow the item to be moved to the
payment class for capped rental items at the same time in all areas of
the country without disrupting CBPs currently underway. For Round 1
Recompete items furnished in nine areas of the country for the six-
month period from July 1, 2016, thru December 31, 2016, Medicare
payment would be on a capped rental basis in all parts of the country
other than these nine areas.
Alternatively, the effective date for the reclassifications could
be January 1, 2014, for all items paid under the fee schedule. In other
words, the reclassification would not affect payments for items
furnished under the Round 2 or Round 1 Recompete CBPs in the respective
CBAs until the contract entered into under these programs expire on
July 1, 2016, and January 1, 2017, respectively. However, this
alternative would result in an extensive two and a half year period
from Janary 2014 through June 2016, where Medicare payment would be on
a capped rental basis for the items in half of the country (non-
competitive bidding areas) and on a purchase basis in the other half of
the country (109 Round 2 and/or Round 1 Recompete competitive bidding
areas). We believe that this bifurcation in payment classifications
would create confusion and would be difficult to implement, and we are
soliciting comments on this alternative implementation strategy.
We have identified approximately 80 HCPCS codes requiring
reclassification from the inexpensive or routinely purchased DME
payment class to the capped rental DME payment class. The codes are
shown in Table 11 below. The impacts of our changes are included in the
discussion of impacts in section X of this rule.
As shown in Table 11, Column A of the table shows the type of DME.
Columns B and C indicate the HCPCS level II codes and the short
descriptor. The long descriptor for each code is available at https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html.
As shown in Column A, the majority of codes relate to manual
wheelchairs and wheelchair accessories. In the case of accessories that
are only used with complex rehabilitative power wheelchairs classified
as capped rental items, the purchase option for complex rehabilitative
power wheelchairs applies to these accessories because they are part of
the capped rental wheelchair that the supplier is required to offer to
the beneficiary on a lump sum purchase basis. We have displayed in
Column B the items that would be associated with the purchase option
set forth at section Sec. 414.229(a)(5). Wheelchair accessories that
are also used with manual wheelchairs or standard power wheelchairs
would also be subject to the purchase option if they are furnished for
use with a complex rehabilitative power wheelchair.
Table 11--Routinely Purchased Items Reclassified to Capped Rental
------------------------------------------------------------------------
Group category HCPCS Descriptor
------------------------------------------------------------------------
Automatic External K0607................. Repl battery for
Defibrillator. AED.
Canes/Crutches................ E0117................. Underarm spring
assist crutch.
Glucose Monitor............... E0620................. Capillary blood
skin piercing
device laser.
High Frequency Chest Wall A7025................. Replace chest
Oscillation Device (HFCWO). compress vest.
Hospital Beds/Accessories..... E0300................. Enclosed ped
crib hosp
grade.
Misc. DMEPOS.................. A4639................. Infrared ht sys
replacement
pad.
E0762................. Trans elec jt
stim dev sys.
E1700................. Jaw motion rehab
system.
Nebulizers & Related Drugs.... K0730................. Ctrl dose inh
drug deliv
system.
Osteogenesis Stimulator....... E0760................. Osteogenesis
ultrasound
stimulator.
Other Neuromuscular E0740................. Incontinence
Stimulators. treatment
system.
E0764................. Functional
neuromuscular
stimulation.
Pneumatic Compression Device.. E0656................. Segmental
pneumatic
trunk.
E0657................. Segmental
pneumatic
chest.
Power Operated Vehicles (POV). E0984................. Add pwr tiller.
Respiratory Equipment......... E0457................. Chest shell.
Speech Generating Devices..... E2500................. SGD digitized
pre-rec <=8min.
E2502................. SGD prerec msg
>8min <=20min.
E2504................. SGD prerec msg
>20min <=40min.
E2506................. SGD prerec msg >
40 min.
E2508................. SGD spelling
phys contact.
E2510................. SGD w multi
methods messg/
access.
Support Surfaces.............. E0197 *............... Air pressure pad
for mattress.
E0198................. Water pressure
pad for
mattress.
Traction Equipment............ E0849................. Cervical pneum
traction equip.
E0855................. Cervical
traction
equipment.
E0856................. Cervical collar
w air bladder.
Walkers....................... E0140 *............... Walker w trunk
support.
E0144................. Enclosed walker
w rear seat.
E0149 *............... Heavy duty
wheeled walker.
Wheelchairs Manual............ E1161................. Manual adult wc
w tiltinspac.
[[Page 40876]]
E1232................. Folding ped wc
tilt-in-space.
E1233................. Rig ped wc
tltnspc w/o
seat.
E1234................. Fld ped wc
tltnspc w/o
seat.
E1235................. Rigid ped wc
adjustable.
E1236................. Folding ped wc
adjustable.
E1237................. Rgd ped wc
adjstabl w/o
seat.
E1238................. Fld ped wc
adjstabl w/o
seat.
Wheelchairs Options/ E0985 *............... W/c seat lift
Accessories. mechanism.
E0986................. Man w/c push-rim
pow assist.
E1002 [supcaret]...... Pwr seat tilt.
E1003 [supcaret]...... Pwr seat
recline.
E1004 [supcaret]...... Pwr seat recline
mech.
E1005 [supcaret]...... Pwr seat recline
pwr.
E1006 [supcaret]...... Pwr seat combo w/
o shear.
E1007 [supcaret]...... Pwr seat combo w/
shear.
E1008 [supcaret]...... Pwr seat combo
pwr shear.
E1010 [supcaret]...... Add pwr leg
elevation.
E1014................. Reclining back
add ped w/c.
E1020 *............... Residual limb
support system.
E1028 *............... W/c manual
swingaway.
E1029................. W/c vent tray
fixed.
E1030 [supcaret]...... W/c vent tray
gimbaled.
E2227................. Gear reduction
drive wheel.
E2228 *............... Mwc acc,
wheelchair
brake.
E2310 [supcaret]...... Electro connect
btw control.
E2311 [supcaret]...... Electro connect
btw 2 sys.
E2312 [supcaret]...... Mini-prop remote
joystick.
E2313 [supcaret]...... PWC harness,
expand control.
E2321 [supcaret]...... Hand interface
joystick.
E2322 [supcaret]...... Mult mech
switches.
E2325 [supcaret]...... Sip and puff
interface.
E2326 [supcaret]...... Breath tube kit.
E2327 [supcaret]...... Head control
interface mech.
E2328 [supcaret]...... Head/extremity
control
interface.
E2329 [supcaret]...... Head control
interface
nonproportional
.
E2330 [supcaret]...... Head control
proximity
switch.
E2351 [supcaret]...... Electronic SGD
interface.
E2368 *............... Pwr wc
drivewheel
motor replace.
E2369 *............... Pwr wc
drivewheel gear
box replace.
E2370 *............... Pwr wc dr wh
motor/gear
comb.
E2373................. Hand/chin ctrl
spec joystick.
E2374 [supcaret]...... Hand/chin ctrl
std joystick.
E2375 *............... Non-expandable
controller.
E2376 [supcaret]...... Expandable
controller,
replace.
E2377 [supcaret]...... Expandable
controller,
initial.
E2378................. Pw actuator
replacement.
K0015 *............... Detach non-adjus
hght armrst.
K0070 *............... Rear whl
complete pneum
tire.
Wheelchairs Seating........... E0955 *............... Cushioned
headrest.
------------------------------------------------------------------------
* Effective July 1, 2016. If the item is furnished in CBAs in accordance
with contracts entered into as part of the Round 1 Recompete of DMEPOS
CBP, then effective January 1, 2017.
[supcaret] Item billable with Complex Rehabilitative Power Wheelchair
codes K0835-K0864.
In summary, we are providing notice of certain HCPCS codes that
would be reclassified as capped rental items (see Table 11 of codes).
We invite comments on this section.
V. Clarification of the 3-Year Minimum Lifetime Requirement (MLR) for
DME
DME is covered by Medicare based, in part, upon section 1832(a) of
the Act, which describes the scope of benefits under the supplementary
medical insurance program (Medicare Part B), to include ``medical and
other health services,'' which is further defined undersection
1861(s)(6) of the Act to include DME. In addition, section 1861(m)(5)
of the Act specifically includes DME in the definition of the term
``home health services.'' In accordance with section 1861(n) of the
Act, the term ``durable medical equipment'' includes iron lungs, oxygen
tents, hospital beds, and wheelchairs used in the patient's home
whether furnished on a rental basis or purchased. The patient's home
includes an institution used as his or her home other than an
institution that meets the requirements of section 1861(e)(1) or
section 1819(a)(1) of the Act. Besides being subject to this provision,
the coverage of DME must meet the requirements of section 1862(a)(1)(A)
of the Act, which in general excludes from payment any items or
services that are not reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member, and section 1862(a)(6) of the Act, which (except
for certain specified exceptions) precludes payment for personal
comfort items.
Section 414.202 defines DME as equipment furnished by a supplier or
a
[[Page 40877]]
home health agency that meets the following conditions: (1) Can
withstand repeated use; (2) effective with respect to items classified
as DME after January 1, 2012, has an expected life of at least 3 years;
(3) is primarily and customarily used to serve a medical purpose; (4)
generally is not useful to an individual in the absence of an illness
or injury; and is appropriate for use in the home. Prior to 2012, the
definition for DME did not contain a 3-year minimum lifetime
requirement (MLR) although Section 110.1 of chapter 15 of the Medicare
Benefit Policy Manual (CMS-Pub. 100-02) provided further guidance with
regard to the definition of DME and durability of an item that is when
an item is considered durable.
B. Current Issues
On November 10, 2011, CMS issued a final rule in which it revised
the definition of DME at Sec. 414.200 by adding a 3-year MLR effective
January 1, 2012, that must be met by an item or device in order to be
considered durable for the purpose of classifying the item under the
Medicare benefit category for DME (76 FR 70228 (November 10, 2011)).
Specifically, an additional condition under Sec. 414.200 is that DME
must be equipment furnished by a supplier or a home health agency that,
effective with respect to items classified as DME after January 1,
2012, has an expected life of at least 3 years. The change to the
regulation was designed to further clarify the meaning of the term
``durable'' and provide an interpretation of the statute generally
consistent with the DME payment and coverage provisions, including,
Medicare program guidance at section 280.1 of chapter 1, part 4 of the
Medicare National Coverage Determinations Manual (Pub. 100-03) which
specifies that an item can withstand repeated use means that the item
could normally be rented and used by successive patients. The 3-year
MLR is intended to specify that durable equipment is equipment that can
withstand repeated use over an extended period of time. Since the vast
majority of items covered under the DME benefit over the years last for
3 or more years, the MLR is intended to clarify the scope of the DME
benefit primarily for new items coming on the market or in the process
of being developed. The standard set forth in regulations gives
manufacturers and the public a clear understanding of how long an item
would need to withstand repeated use in order the meet the durability
requirement for DME. The rule also provides clear guidance to CMS and
other stakeholders for making consistent informal benefit category
determinations and national coverage determinations for DME.
The 3-year MLR is designed to represent a minimum threshold for a
determination of durability for a piece of equipment. The 3-year MLR is
not an indication of the typical or average lifespan of DME, which in
many cases is far longer than 3 years. The 3-year MLR does not apply to
disposable supplies or accessories covered for use with DME such as
masks, tubing, and blood glucose test strips. The 3-year MLR is
prospective only and does not apply to equipment classified as DME
before the regulation was effective, that is, January 1, 2012.
We also determined that the 3-year MLR should not apply to
equipment classified as DME before the effective date to allow for
continued coverage of such equipment that healthcare industry and
beneficiaries have come to rely on, regardless of whether those items
met the 3-year MLR set forth at 42 CFR 414.202 (76 FR 70288). Given
that reliance, we did not intend to reopen those prior decisions and
reclassify the equipment in light of the 3-year standard. We believe
that continuing Medicare coverage for items that qualified as DME prior
to the effective date, helps avoid disrupting the continuity of care
for the beneficiaries that received these items for medical treatment
prior to January 1, 2012.
Beneficiaries have been relying on these items for their treatment
to the extent that the items have been covered as DME under Medicare
and applying the 3-year MLR to these items could impact the continuity
of care for these beneficiaries. Furthermore, we believed that a vast
majority of the categories of items that were classified as DME before
January 1, 2012, did function for 3 or more years. We also noted that
the 3-year durability rule would only apply to new products, and, to
the extent that a modified product is not a new product, the 3-year MLR
would not be applicable.
In response to the public comments that requested further
clarification on the application of the grandfathering provision for
the 3-year MLR, we noted that we would consider issuing additional
guidance to provide further clarification, if necessary (76 FR 70290).
For purposes of providing additional guidance on the scope of the
grandfathered items under the provision, we invite public comments on
this issue.
C. Scope of the 3-Year MLR for DME
Under Sec. 414.202, effective with respect to items classified as
DME after January 1, 2012, an item is not considered durable unless it
has an expected life of at least 3 years. Therefore, the 3-year MLR
applies to new items after January 1, 2012, and does not apply to items
covered under the DME benefit on or prior to January 1, 2012. Items
classified as DME on or before January 1, 2012, are considered
``grandfathered items'' for the purpose of this requirement, regardless
of whether they meet the 3-year rule.
For the purpose of providing further guidance on the scope of the
3-year MLR, we are providing clarification about how we would regard
grandfathered items covered as DME prior to the effective date and we
request comments on that clarification. If the product is modified
(upgraded, refined, reengineered, etc.) after January 1, 2012, the item
would still be classified as DME as a grandfathered item unless the
modified product now has an expected life that is shorter than the
expected lifetime for the item covered as DME prior to January 1, 2012,
In this case, we consider the item, as modified, to be a new item that
is subject to the 3-year MLR. For example, equipment covered prior to
January 1, 2012, and described by code X has a life of at least 2
years. If, after January 1, 2012, that item is modified such that it no
longer lasts 2 years, such modification would render the item ``new''
and it would be subject to the 3-year MLR. Therefore, since the new
(modified) product does not last 3 years, it would not meet the
definition of DME under the regulation and could not be covered or be
billed using the code that described the item before it was modified.
We seek comments on this proposed clarification.
VI. Implementation of Budget-Neutral Fee Schedules for Splints, Casts
and Intraocular Lenses (IOLs)
A. Background
1. Payment Under Reasonable Charges
Payment for most items and services furnished under Part B of the
Medicare program is made through contractors known as Medicare
Administrative Contractors (MACs). These contractors were previously
referred to as carriers. Prior to 1988, in accordance with section
1842(b) of the Act, payment for most of these items and services was
made on a reasonable charge basis by these contractors, with the
criteria for determining reasonable charges set forth at 42 CFR part
405, subpart E of our regulations.
Under this general methodology, several factors or ``charge
screens'' were developed for determining the
[[Page 40878]]
reasonable charge for an item or service. In accordance with Sec.
405.503, each supplier's ``customary charge'' for an item or service,
or the 50th percentile of charges for an item or service over a 12-
month period, was one factor used in determining the reasonable charge.
In accordance with Sec. 405.504, the ``prevailing charge'' in a local
area, or the 75th percentile of suppliers' customary charges for the
item in the locality, was also used in determining the reasonable
charge. For the purpose of calculating prevailing charges, a
``locality'' is defined at Sec. 405.505 of our regulations and ``may
be a State (including the District of Columbia, a territory, or a
Commonwealth), a political or economic subdivision of a State, or a
group of States.'' The regulation further specifies that the locality
``should include a cross section of the population with respect to
economic and other characteristics.'' In accordance with Sec. 405.506,
for certain items, such as parenteral and enteral nutrients, supplies,
and equipment, an additional factor referred to as the ``lowest charge
level'' was used in determining the reasonable charge for an item or
service. In accordance with section 5025 of the Medicare Carriers
Manual (HCFA Pub. 14-3) and Sec. 405.509 of our regulations, effective
for items furnished on or after October 1, 1985, an additional factor,
the ``inflation-indexed charge (IIC),'' was added to the factors taken
into consideration in determining the reasonable charge for certain
items and services. The IIC is defined in Sec. 405.509(a) as the
lowest of the fee screens used to determine reasonable charges for
items and services, including supplies, and equipment reimbursed on a
reasonable charge basis (excluding physicians' services) that is in
effect on December 31 of the previous fee screen year, updated by the
inflation adjustment factor. The inflation adjustment factor is based
on the current percentage change in the consumer price index for all
urban consumers (United States city average) (CPI-U) for the 12-month
period ending June 30. The reasonable charge is generally set based on
the lowest of the actual charge for the item or service or the factors
described above.
2. Payment Under Fee Schedules
Specific provisions have been added to the Act mandating
replacement of the reasonable charge payment methodology with fee
schedules for most items and services furnished under Part B of the
Medicare program. The phase in of fee schedules to replace reasonable
charges for Medicare payment purposes began with the fee schedule for
clinical diagnostic laboratory tests in 1988. As of 1997, very few
items and services were still paid on a reasonable charge basis, which
is a very time consuming and laborious process. Contractors must
collect new charge data each year, perform the various calculations,
and maintain pricing files and claims processing edits for the various
charge screens. For each item that is paid on a reasonable charge
basis, administrative funding must be provided to contractors for the
purpose of performing these calculations and maintaining these pricing
files. Therefore, replacing reasonable charge payments with fee
schedules eliminates the need to fund these efforts and saves money
that can be used to implement other parts of the program. Section 4315
of the Balanced Budget Act of 1997 (BBA) amended the Act at section
1842 by adding a new subsection (s). Section 1842(s) of the Act
provides authority for implementing statewide or other area wide fee
schedules to be used for payment of the following services that were
previously on a reasonable charge basis:
Medical supplies.
Home dialysis supplies and equipment (as defined in
section 1881(b)(8) of the Act).
Therapeutic shoes.
Parenteral and enteral nutrients, equipment, and supplies
(PEN).
Electromyogram devices.
Salivation devices.
Blood products.
Transfusion medicine.
For Medicare payment purposes, we interpret the category ``medical
supplies'' under section 1842(s) of the Act to include all other items
paid on a reasonable charge basis as of 1997 that do not fall under any
of the other categories listed in section 1842(s) of the Act. We
believe that section 1842(s) of the Act is intended to provide
authority for establishing fee schedules for all of the remaining, and
relatively small number of items and services still paid for on a
reasonable charge basis at the time of enactment in 1997. In light of
this provision, we generally consider ``intraocular lenses'' to be paid
as ``medical supplies.'' Therefore, in addition to including splints
and casts under this category, we also propose to include intraocular
lenses inserted in a physician's office for the purpose of implementing
this specific section. Although we recognize the terms ``intraocular
lenses'' and ``medical supplies'' are separately identified under Sec.
414.202, we note that such terms are listed for purposes of defining
what constitutes orthotic and prosthetic devices (that is, these terms
are excluded from such definition), and not intended to suggest these
are mutually exclusive things. Accordingly, we do not believe we are
precluded from establishing fee schedules for IOLs under the category
of medical supplies under section 1842(s) of the Act. Nevertheless, we
are specifically requesting comments on this issue.
Section 1842(s)(1) of the Act provides that the fee schedules for
the services listed above are to be updated on an annual basis by the
percentage increase in the CPI-U (United States city average) for the
12-month period ending with June of the preceding year, reduced by the
productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of
the Act. Total payments for the initial year of the fee schedules must
be budget-neutral, or approximately equal to the estimated total
payments that would have been made under the reasonable charge payment
methodology. As explained below, we used this authority to establish
fee schedules for parental and enteral nutrition (PEN) items and
services for use in paying claims with dates of service on or after
January 1, 2002.
On July 27, 1999, we published a notice of proposed rulemaking (64
FR 40534) to establish fee schedules for PEN items and services,
splints and casts, intraocular lenses (IOLs) inserted in a physician's
office, and various other items and services for which section 1842(s)
of the Act provided authority for replacing the reasonable charge
payment methodology with fee schedules. After reviewing public comments
on the proposed rule, we decided to move ahead with a final rule
establishing fee schedules for the Parenteral and Enteral Nutrition
(PEN) items and services, but not the other items and services,
primarily related to concerns regarding data used for calculating fee
schedule amounts for items and service that are no longer paid on a
reasonable charge basis. The final rule for implementing the fee
schedules for PEN items and services was published on August 28, 2001
(66 FR 45173). For splints and casts, national reasonable charge
amounts, updated on an annual basis by the IIC, have been used to pay
for the splint and cast materials. Converting these amounts to national
fee schedule amounts that are updated by the same index factor used in
updating the reasonable charge amounts would result in no change in
payment, or 100 percent budget-neutrality. Currently, very few IOLs are
inserted in a physician's office nationally. In 2011, total allowed
charges for 437 IOLs furnished to 287
[[Page 40879]]
beneficiaries equaled $75,914. Since IOLs are considerably low volume
items furnished by very few suppliers nationally, there are some states
where none of these items are furnished; therefore, charge data for use
in calculating prevailing charges, even at the state level, are not
available and budget-neutrality is not an issue. If the national
average allowed amount for these items is used as the fee schedule
amount for the few IOLs that are still inserted in a physician's
office, we do not believe that total allowed charges in the first year
of the fee schedule would be significantly different than what would
otherwise be paid nationally under the current reasonable charge
payment methodology. For 2011, the national average allowed charge for
covered claims for the 287 beneficiaries receiving IOLs inserted in a
physician's office was $174 ($75,914 / 437). In some cases, the allowed
charge for specific claims in 2011 was less than $174 and in other
cases the allowed charge was more than $174. However, given the low
volume of items furnished nationally, the budget impact of paying all
of the approximately 437 claims based on the national average allowed
amount would be negligible. We believe establishing budget-neutral fee
schedule amounts for splints and casts, and IOLs inserted in a
physician's office will save government resources in calculating the
reasonable charge payment for the low volume items. We are proposing to
establish fee schedules for these items effective for paying claims
with dates of service on or after January 1, 2014.
B. Provisions of the Proposed Regulations
For the reasons we articulated above, we propose, under section
1842(s) of the Act, to implement fee schedules for splints and casts,
and IOLs inserted in a physician's office falling under the category of
medical supplies. In addendum C of this proposed rule, we have inserted
the current 2013 reasonable charge amounts for splints, casts and IOLs
inserted in a physician's office. The splints and casts are payment
amount limits updated by the CPI-U factor ending with June of the
preceding year, in this case June 2012. The IOLs inserted in
physician's office estimates the 2012 average allowed charge. We would
not have the entire calendar year estimates for 2013 average allowed
charge for IOLs inserted in a physician's office in order to implement
the fee schedule amounts for these items effective for paying claims
with dates of service on or after January 1, 2014; therefore, we are
using the estimate of the 2012 average allowed charge. The final fee
schedule amount will be specified in the final rule. We currently do
not have the percentage change in the CPI-U for the 12-month period
ending with June of 2013 to update the fee-schedule amounts for splints
and casts. Specifically, we are proposing to amend 42 CFR Sec. 414.106
and Sec. 414.100 to include the general rule for updating the fee
schedules for splints, casts and IOLs inserted in a physician's office.
We are also proposing to add Sec. 414.106 and Sec. 414.108 to set
forth the fee schedule methodology and updates as explained above for
splints, casts, and IOLs inserted in a physician's office. Subject to
coinsurance and deductible rules, Medicare payment for these services
is to be equal to the lower of the actual charge for the item or the
amount determined under the applicable fee schedule payment
methodology.
For splints and casts, we propose national fee schedule amounts for
items furnished from January 1, 2014, thru December 31, 2014, based on
2013 reasonable charges updated by the percentage increase in the
consumer price index for all urban consumers (United States city
average) for the 12-month period ending with June 2013. For subsequent
years, the fee schedule amounts would be updated by the percentage
increase in the consumer price index for all urban consumers (United
States city average) for the 12-month period ending with June of the
preceding year, reduced by the productivity adjustment as described in
section 1886(b)(3)(B)(xi)(II) of the Act.
For IOLs inserted in a physician's office, we propose national fee
schedule amounts for items furnished from January 1, 2014, thru
December 31, 2014, based on the national average allowed charge for the
item from January 1, 2012 through December 31, 2012, updated by the
percentage increase in the consumer price index for all urban consumers
(United States city average) for the 24-month period ending with June
2013. For subsequent years, the fee schedule amounts would be updated
by the percentage increase in the consumer price index for all urban
consumers (United States city average) for the 12-month period ending
with June of the preceding year, reduced by the productivity adjustment
as described in section 1886(b)(3)(B)(xi)(II) of the Act.
VII. DMEPOS Technical Amendments and Corrections
A. Background
Medicare pays for various DMEPOS items and services based on
payment rules that are set forth in section 1834 of the Act and 42 CFR
Part 414, Subpart D. We propose to make three minor, conforming
technical amendments to the existing DMEPOS payment regulations (the
title of Subpart D and 42 CFR Sec. 414.200 and Sec. 414.226).
B. Proposed Technical Amendments and Corrections
Below are the proposed technical amendments.
We propose to modify the title of ``Subpart D--Payment for
Durable Medical Equipment, Prosthetic and Orthotic Devices'' to read
``Subpart D--Payment for Durable Medical Equipment, Prosthetic and
Orthotic Devices, and Surgical Dressings'' to reflect that payment for
surgical dressings is addressed under this subpart at Sec. 414.220(g).
In subpart Sec. 414.200, we propose to modify the phrase
``This subpart implements sections 1834 (a) and (h) of the Act by
specifying how payments are made for the purchase or rental of new and
used durable medical equipment and prosthetic and orthotic devices for
Medicare beneficiaries.'' as follows: ``This subpart implements
sections 1834 (a),(h), and (i) of the Act by specifying how payments
are made for the purchase or rental of new and used durable medical
equipment, prosthetic and orthotic devices, and surgical dressings for
Medicare beneficiaries.'' The Omnibus Budget Reconciliation Act of 1993
amended section 1834 of the Act by adding subsection (i), mandating
payment on a fee schedule basis for surgical dressings. Although Sec.
414.220(g) addresses this requirement, the regulation at Sec. 414.200
was not updated to indicate that this subpart implements section
1834(i) in addition to sections 1834(a) and (h) of the Act.
Section 1834(a)(9)(D) of the Act provides authority for
creating separate classes of oxygen and oxygen equipment. Section
1834(a)(9)(D)(ii) of the Act prohibits CMS from creating separate
classes of oxygen and oxygen equipment that result in expenditures for
any year that are more or less than expenditures which would have been
made if the separate classes had not been created. In other words, the
new classes and payment amounts for oxygen and oxygen equipment must be
established so that creating the new classes is annually budget-
neutral. In November 2006, we published a final rule establishing
separate classes for oxygen and oxygen equipment and included a
methodology for meeting the requirements of section 1834(a)(9)(D)(ii)
of the Act by applying annual reductions to the monthly fee schedule
amounts for the stationary oxygen
[[Page 40880]]
equipment class at Sec. 414.226(c)(1)(i) in order to establish budget
neutrality for total oxygen and oxygen expenditures for all oxygen
classes. Increases in expenditures for oxygen and oxygen equipment that
are attributed to higher payment amounts established for new classes of
oxygen and oxygen equipment are off set by reducing the monthly payment
amount for stationary oxygen equipment. Due to a drafting error in the
regulation text portion of the November 2006 final rule, CMS-1304-F (71
FR 65933), 42 CFR Sec. 414.226(c)(6) needs to be corrected. The
regulation text at Sec. 414.226(c)(6) mistakenly states that budget
neutrality should be achieved by adjusting all oxygen class rates.
Section 414.226(c)(6) should read that only the stationary oxygen
equipment rate should be adjusted to achieve budget neutrality.
Therefore, we propose that Sec. 414.226(c)(6) be revised to read as
follows: ``Beginning in 2008, CMS makes an annual adjustment to the
national limited monthly payment rate for items described in paragraph
(c)(1)(i) of this section to ensure that such payment rates do not
result in expenditures for any year that are more or less than the
expenditures that would have been made if such classes had not been
established.''
We are also making a technical correction to existing 42
CFR Sec. 414.102(c) to conform the regulation governing parenteral and
enteral (PEN) nutrients, equipment and supplies covered item fee
schedule update with the statute. Although section 1842(s)(1)(B)(ii) of
the Act is self-implementing, the PEN nutrients, equipment and supplies
payment regulations at 42 CFR 414 Subpart C were not updated to reflect
the application of the multifactor productivity adjustment to the CPI-U
update factor for 2011 and subsequent calendar years. Therefore, we are
revising Sec. 414.102(c) of our regulations to specify that for years
2003 through 2010, the PEN items and services fee schedule amounts of
the preceding year are updated by the percentage increase in the CPI-U
for the 12-month period ending with June of the preceding year. For
each year subsequent to 2010, the PEN items and services fee schedule
amounts of the preceding year are updated by the percentage increase in
the CPI-U for the 12-month period ending with June of the preceding
year, reduced by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act.
VIII. Collection of Information Requirements
A. Legislative Requirement for Solicitation of Comments
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day 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. In
order to fairly evaluate whether an information collection requirement
should be approved by OMB, section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 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 estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
B. Requirements in Regulation Text
In section II.D. of this proposed rule, we are proposing changes to
regulatory text for the ESRD PPS in CY 2014. However, the changes that
are being proposed do not impose any new information collection
requirements.
C. Additional Information Collection Requirements
This proposed rule does not impose any new information collection
requirements in the regulation text, as specified above. However, this
proposed rule does make reference to several associated information
collections that are not discussed in the regulation text contained in
this document. The following is a discussion of these information
collections.
1. ESRD QIP
a. Proposed Expanded ICH CAHPS Reporting Measure for PY 2016 and Future
Payment Years of the ESRD QIP
As stated above in section III.C.2.a of this proposed rule, we
proposed to include in the PY 2016 ESRD QIP an expanded ICH CAHPS
reporting measure, which assesses facility usage of the ICH CAHPS
survey. Unlike the ICH CAHPS reporting measure finalized in the CY 2013
ESRD PPS final rule (77 FR 67480 through 67481), the proposed expanded
ICH CAHPS reporting measure would require facilities to report (via a
CMS-approved vendor) survey data to CMS once for PY 2016, and, for PY
2017 and beyond, to administer (via a CMS-approved vendor) a second ICH
CAHPS survey and report the second set of survey data to CMS.
Therefore, for PY 2016, we estimate the burden associated with this
requirement to be the time and effort necessary for facilities to
submit (via a CMS-approved vendor) survey results to CMS. For PY 2017
and future payment years, we estimate the burden associated with this
requirement is the time and effort necessary for facilities to
administer (via a CMS-approved vendor) a second ICH CAHPS survey and
submit (via a CMS-approved vendor) the survey results to CMS.
We estimate that approximately 5,506 facilities will treat adult,
in-center hemodialysis patients in PY 2016 and, therefore, will be
eligible to receive a score on this measure. We further estimate that
all 5,506 facilities will report (via a CMS-approved vendor) survey
results to CMS, and that it will take each vendor approximately 5
minutes to do so. Therefore, the estimated total annual burden
associated with meeting the measure requirements in PY 2016 is 459
hours [(5/60) hours x 5,506 facilities). According to the Bureau of
Labor Statistics, the mean hourly wage of a registered nurse is $32.66/
hour. Since we anticipate nurses (or administrative staff who would be
paid at a lower hourly wage) will submit this data to CMS, we estimate
that the aggregate cost of this requirement for PY 2016 will be $14,991
(459 hours x $32.66/hour).
We estimate that approximately 5,693 facilities will treat adult,
in-center hemodialysis patients in PY 2017 and, therefore, will be
eligible to receive a score on this measure. We estimate that all 5,693
facilities will administer the ICH CAHPS survey through a third-party
vendor and arrange for the vendor to submit the data to CMS. We
estimate that it would take each patient 30 minutes to complete the
survey (to account for variability in education levels) and that
approximately 103 surveys per year would be taken per facility.
Interviewers from each vendor would therefore spend a total of
approximately 52 hours per year with patients completing these surveys
(0.5 hours * 103 surveys) or $1,698 (52 hours x $32.66) for an
estimated annual burden of $9,666,714 ($1,698 per facility x 5,693
facilities).\9\ We previously estimated that the aggregate cost of
submitting survey data to CMS is $14,991. Therefore, we estimate that
the
[[Page 40881]]
total annual burden for ESRD facilities to comply with the collection
of information requirements associated with the proposed expanded ICH
CAHPS measure for PY 2017 and future payment years would be
approximately $9,681,705 ($9,666,714 + $14,991) across all ESRD
facilities.
---------------------------------------------------------------------------
\9\ We note that this total represents an underestimate of the
overall burden because it does not include time costs for patients.
---------------------------------------------------------------------------
b. Proposed Data Validation Requirements for the PY 2016 ESRD QIP
Section III.C.13 of the proposed rule outlines our data validation
proposals. We proposed to randomly sample records from 300 facilities;
each sampled facility would be required to produce up to 10 records;
and the sampled facilities will be reimbursed by our validation
contractor for the costs associated with copying and mailing the
requested records. The burden associated with this validation
requirement is the time and effort necessary to submit validation data
to a CMS contractor. We estimate that it will take each facility
approximately 2.5 hours to comply with these requirements. If 300
facilities are tasked with providing the required documentation, the
estimated annual burden for these facilities across all facilities
would be 750 hours (300 facilities x 2.5 hours) at a total of $24,495
(750 hours x $32.66/hour) or $81.65 ($24,495/300 facilities) per
facility in the sample.
2. The discussion on clarifying the definition of routinely
purchased DME does not contain any new information collection
requirements.
3. The clarification of the the 3-year Minimum Lifetime Requirement
for DME does not contain any new information collection requirements.
4. The proposed implementation of Budget-Neutral Fee Schedules for
Splints, Casts and Intraocular Lenses does not contain any new
information collection requirements.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site at https://www.cms.gov/PaperworkReductionActof1995/PRAL/list.asp#TopOfPage.
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
[CMS-1526-P], Fax: (202) 395-6974; or Email: OIRA_submission@omb.eop.gov.
IX. 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.
X. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
We examined the impacts of this proposed rule as required by
Executive Order 12866 (September 30, 1993, Regulatory Planning and
Review) and Executive Order 13563 on Improving Regulation and
Regulatory Review (January 18, 2011). 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 economically significant under section 3(f)(1) of Executive
Order 12866. Accordingly, the rule has been reviewed by the Office of
Management and Budget. We have prepared a Regulatory Impact Analysis
that to the best of our ability presents the costs and benefits of the
proposed rule. We solicit comments on the regulatory impact analysis
provided.
2. Statement of Need
This rule proposes a number of routine updates for renal dialysis
services in CY 2014, proposes to implement the fourth year of the ESRD
PPS transition, and proposes to make several policy changes to the ESRD
PPS. These include proposed updates and changes to the ESRD PPS base
rate, wage index values, the wage index budget-neutrality adjustment
factor, and the outlier payment policy. This rule will also implement
section 1881(b)(14)(I), which requires the Secretary, by comparing per
patient utilization from 2007 with such data from 2012, to reduce the
single payment amount to reflect the Secretary's estimate of the change
in the utilization of ESRD-related drugs and biologicals. Failure to
publish this proposed rule would result in ESRD facilities not
receiving appropriate payments in CY 2014.
This rule proposes to implement the ESRD QIP for PY 2016 and beyond
by proposing to adopt measures, scoring, and payment reductions to
incentivize improvements in dialysis care as directed by section
1881(h) of the Act. Failure to propose requirements for the PY 2016
ESRD QIP would prevent continuation of the ESRD QIP beyond PY 2015.
3. Overall Impact
We estimate that the proposed revisions to the ESRD PPS will result
in a decrease of approximately $970 million in payments to ESRD
facilities in CY 2014, which includes the amount associated with the
increase in the ESRDB market basket reduced by the productivity
adjustment, updates to outlier threshold amounts, the inclusion of the
Pacific Rim ESRD facilities, updates to the wage index, and the drug
utilization adjustment required by section 1881(b)(14)(I), as added by
section 632(a) of ATRA.
For PY 2016, we estimate that the proposed requirements related to
the ESRD QIP will cost approximately $39.5 thousand and the predicted
payment reductions will equal about $26.4 million to result in a total
impact from the proposed ESRD QIP requirements of $26.4 million. For PY
2017 and future payment years, we expect the costs associated with the
collection of information requirements for the expanded ICH CAHPS
measure in the proposed ESRD QIP to be approximately $9.7 million.
We estimate that the proposed changes for implementing the fee
schedule amounts from reasonable charge payments will be budget neutral
and will have no impact to DMEPOS providers of splints, casts and
intraocular lenses inserted in a physician's office.
We estimate that our proposed clarification of the definition of
routinely purchased DME and re-classification of certain items as cap
rental items would impact certain DMEPOS providers. We estimate that
the clarification of the 3-year minimum lifetime requirement for DME
would have no impact on DMEPOS suppliers.
[[Page 40882]]
B. Detailed Economic Analysis
1. CY 2014 End-Stage Renal Disease Prospective Payment System
a. Effects on ESRD Facilities
To understand the impact of the changes affecting payments to
different categories of ESRD facilities, it is necessary to compare
estimated payments in CY 2013 to estimated payments in CY 2014. To
estimate the impact among various types of ESRD facilities, it is
imperative that the estimates of payments in CY 2013 and CY 2014
contain similar inputs. Therefore, we simulated payments only for those
ESRD facilities for which we are able to calculate both current
payments and new payments.
For this proposed rule, we used the December 2012 update of CY 2012
National Claims History file as a basis for Medicare dialysis
treatments and payments under the ESRD PPS. We updated the 2012 claims
to 2013 and 2014 using various updates. The updates to the ESRD PPS
base rate are described in section II.B of this proposed rule. Table 12
shows the impact of the estimated CY 2014 ESRD payments compared to
estimated payments to ESRD facilities in CY 2013.
Table 12--Impact of Proposed Changes in Payments to ESRD Facilities for CY 2014 Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effect of 2014
changes in Effect of 2014
Number of Effect of 2014 Effect of 2014 market basket changes in Effect of
Facility type Number of treatments changes in changes in minus base rate due total 2014
facilities (in outlier policy wage indexes productivity to drug changes \5\
millions) \4\ (percent) (percent) update utilization (percent)
(percent) (percent)
A B C D E F G
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Facilities................................... 5,771 38.1 0.4 0.0 2.5 -12.0 -9.4
Type:
Freestanding................................. 5,270 35.4 0.4 0.0 2.5 -12.0 -9.4
Hospital based............................... 501 2.7 0.3 0.1 2.5 -11.9 -9.3
Ownership Type:
Large dialysis organization.................. 3,769 25.9 0.4 0.0 2.5 -12.0 -9.4
Regional chain............................... 885 6.1 0.4 0.0 2.5 -12.0 -9.4
Independent.................................. 614 3.9 0.2 0.1 2.5 -12.0 -9.5
Hospital based \1\........................... 400 2.1 0.2 0.1 2.5 -11.9 -9.4
Unknown...................................... 103 0.2 0.3 -0.2 2.5 -12.0 -9.6
Geographic Location:
Rural........................................ 1,257 6.3 0.4 -0.1 2.5 -12.0 -9.5
Urban........................................ 4,514 31.8 0.4 0.0 2.5 -12.0 -9.4
Census Region:
East North Central........................... 946 5.7 0.4 -0.2 2.5 -11.9 -9.5
East South Central........................... 477 2.9 0.5 -0.2 2.5 -11.9 -9.5
Middle Atlantic.............................. 634 4.6 0.4 0.5 2.5 -12.0 -9.0
Mountain..................................... 340 1.8 0.3 0.1 2.5 -12.0 -9.4
New England.................................. 170 1.3 0.4 0.2 2.5 -12.0 -9.2
Pacific \2\.................................. 684 5.3 0.1 0.4 2.5 -12.0 -9.3
Puerto Rico and Virgin Islands............... 41 0.3 0.4 -2.3 2.5 -11.9 -11.5
South Atlantic............................... 1,288 8.8 0.5 -0.3 2.5 -12.0 -9.6
West North Central........................... 416 2.0 0.4 -0.1 2.5 -12.0 -9.5
West South Central........................... 775 5.5 0.5 -0.1 2.5 -11.9 -9.5
Facility Size:
Less than 4,000 treatments \3\............... 1,044 2.6 0.4 0.0 2.5 -12.0 -9.4
4,000 to 9,999 treatments.................... 2,157 10.4 0.4 -0.1 2.5 -12.0 -9.5
10,000 or more treatments.................... 2,400 24.7 0.4 0.0 2.5 -12.0 -9.4
Unknown...................................... 170 0.4 0.4 -0.1 2.5 -12.0 -9.5
Percentage of Pediatric Patients:
Less than 2%................................. 5,662 37.7 0.4 0.0 2.5 -12.0 -9.4
Between 2% and 19%........................... 44 0.3 0.3 0.0 2.5 -11.9 -9.5
Between 20% and 49%.......................... 6 0.0 0.1 -0.3 2.5 -12.0 -9.9
More than 50%................................ 59 0.1 0.0 0.1 2.5 -12.0 -9.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Includes hospital-based ESRD facilities not reported to have large dialysis organization or regional chain ownership.
\2\ Includes ESRD facilities located in Guam, American Samoa, and the Northern Mariana Islands.
\3\ Of the 1,044 ESRD facilities with less than 4,000 treatments, only 375 qualify for the low-volume adjustment. The low-volume adjustment is mandated
by Congress, and is not applied to pediatric patients. The impact to these low-volume facilities is a 9.5 percent decrease in payments.
\4\ Includes the effect of including the Pacific Rim ESRD facilities of Guam, American Samoa, and the Northern Mariana Islands into the PPS.
\5\ Includes the effect of Market Basket minus productivity increase of 2.5 percent to the ESRD PPS base rate and the effect of the $29.52 decrease in
the base rate due to the drop in drug utilization.
Note:Totals do not necessarily equal the sum of rounded parts, as percentages are multiplicative, not additive.
Column A of the impact table indicates the number of ESRD
facilities for each impact category and column B indicates the number
of dialysis treatments (in millions). The overall effect of the
proposed changes to the outlier payment policy described in section
II.B.6. of this proposed rule is shown in column C. For CY 2014, the
[[Page 40883]]
impact on all facilities as a result of the changes to the outlier
payment policy would be a 0.4 percent increase in estimated payments.
The estimated impact of the changes to outlier payment policy ranges
from a 0.0 percent to a 0.5 percent increase. Nearly all ESRD
facilities are anticipated to experience a positive effect in their
estimated CY 2014 payments as a result of the proposed outlier policy
changes.
Column D shows the effect of the wage index on ESRD facilities and
reflects the CY 2014 wage index values for the ESRD PPS payments.
Facilities located in the census region of Puerto Rico and the Virgin
Islands would receive a 2.3 percent decrease in estimated payments in
CY 2014. Since most of the facilities in this category are located in
Puerto Rico, the decrease is primarily due to the reduction in the wage
index floor, (which only affects facilities in Puerto Rico in CY 2014).
The other categories of types of facilities in the impact table show
changes in estimated payments ranging from a 0.3 percent decrease to a
0.5 percent increase due to the update of the wage index.
Column E shows the effect of the ESRDB market basket increase minus
productivity adjustment. The impact on all facilities would be a 2.5
percent increase.
Column F shows the effect of the drug utilization adjustment
required by section 1881(b)(14)(I). For CY 2014, the impact on all
facilities as a result of the $29.52 decrease to the base rate, as
described in section II.B.2.a., would be a 12 percent decrease in
estimated payments. The estimated impact ranges from 11.9 percent to 12
percent decrease.
Column G reflects the overall impact (that is, the effects of the
proposed outlier policy changes, the proposed wage index, the effect of
the ESRDB market basket increase minus productivity adjustment, and the
effect of the drug utilization adjustment required by section
1881(b)(14)(I). We expect that overall, ESRD facilities will experience
a 9.4 percent decrease in estimated payments in 2014. ESRD facilities
in Puerto Rico and the Virgin Islands are expected to receive an 11.5
percent decrease in their estimated payments in CY 2014. This larger
decrease is primarily due to the negative impact of the wage index. The
other categories of types of facilities in the impact table show
negative impacts ranging from a decrease of 9.9 percent to 9.0 percent
in their 2014 estimated payments.
b. Effects on Other Providers
Under the ESRD PPS, ESRD facilities are paid directly for the renal
dialysis bundle and other provider types such as laboratories, DME
suppliers, and pharmacies, may no longer bill Medicare directly for
renal dialysis services. Rather, effective January 1, 2011, such other
providers can only furnish renal dialysis services under arrangements
with ESRD facilities and must seek payment from ESRD facilities rather
than Medicare. Under the ESRD PPS, Medicare pays ESRD facilities one
payment for renal dialysis services, which may have been separately
paid to suppliers by Medicare prior to the implementation of the ESRD
PPS. Therefore, in CY 2014, the fourth year of the ESRD PPS, we
estimate that the proposed ESRD PPS will have zero impact on these
other providers.
c. Effects on the Medicare Program
We estimate that Medicare spending (total Medicare program
payments) for ESRD facilities in CY 2014 will be approximately $8
billion. This estimate takes into account a projected increase in fee-
for-service Medicare dialysis beneficiary enrollment of 3.8 percent in
CY 2014.
d. Effects on Medicare Beneficiaries
Under the ESRD PPS, beneficiaries are responsible for paying 20
percent of the ESRD PPS payment amount. As a result of the projected
9.4 percent overall decrease in the proposed ESRD PPS payment amounts
in CY 2014, we estimate that there will be a decrease in beneficiary
co-insurance payments of 9.4 percent in CY 2014, which translates to
approximately $190 million.
e. Alternatives Considered
For this proposed rule, we proposed to implement the full reduction
required by section 1881(b)(14)(I) in CY 2014. In particular, we
proposed a one-time reduction of $29.52 to the ESRD PPS base rate. We
considered proposing to implement the reduction using a transition. For
example, we considered transitioning the reduction over a 2 or 3-year
period. We chose to implement the full reduction by reducing the ESRD
PPS base rate by an adjustment to reflect change in the utilization of
ESRD-related drugs and biologicals by comparing utilization data from
2007 with such data from 2012.
2. End-Stage Renal Disease Quality Incentive Program
a. Effects of the PY 2016 ESRD QIP
The ESRD QIP provisions are intended to prevent possible reductions
in the quality of ESRD dialysis facility services provided to
beneficiaries as a result of payment changes under the ESRD PPS by
implementing a ESRD QIP that reduces ESRD PPS payments by up to 2
percent for dialysis facilities that fail to meet or exceed a TPS with
respect to performance standards established by the Secretary with
respect to certain specified measures. The methodology that we are
proposing to determine a facility's TPS is described in section
III.C.11 of this proposed rule. Any reductions in ESRD PPS payments as
a result of a facility's performance under the PY 2016 ESRD QIP would
begin with services furnished on January 1, 2016.
As a result, based on the ESRD QIP outlined in this proposed rule,
we estimate that, of the total number of dialysis facilities (including
those not receiving an ESRD QIP TPS), approximately 36 percent or 2,069
of the facilities would likely receive a payment reduction in PY 2016.
Facilities that do not receive a TPS are not eligible for a payment
reduction.
The ESRD QIP impact assessment assumes an initial count of 5,771
dialysis facilities paid through the PPS. Table 13 shows the overall
estimated distribution of payment reductions resulting from the PY 2016
ESRD QIP.
Table 13--Estimated Distribution of PY 2016 ESRD QIP Payment Reductions
------------------------------------------------------------------------
Number of Percent of
Payment reduction percent facilities facilities
------------------------------------------------------------------------
0.0........................................... 3,417 62.3
0.5........................................... 994 18.1
1.0........................................... 583 10.6
1.5........................................... 280 5.1
2.0........................................... 212 3.9
------------------------------------------------------------------------
Note:This table excludes 285 facilities that did not receive a score
because they did not have enough data to receive a Total Performance
Score.
To estimate whether or not a facility would receive a payment
reduction under the proposed approach, we scored each facility on
achievement and improvement on several measures we have previously
finalized and for which there were available data from CROWNWeb and
Medicare claims. Measures used for the simulation are shown in Table
14.
[[Page 40884]]
Table 14--Data Used To Estimate PY 2016 ESRD QIP Payment Reductions
------------------------------------------------------------------------
Period of time
used to
calculate
achievement
thresholds,
Measure performance Performance period
standards,
benchmarks, and
improvement
thresholds
------------------------------------------------------------------------
Hemoglobin Greater Than 12 g/ Jan 2012-Jun July 2012-Dec 2012.
dL. 2012.
Vascular Access Type:
% Fistula............... Jan 2011-Dec Jan 2012-Dec 2012.
2011.
% Catheter.............. Jan 2011-Dec Jan 2012-Dec 2012.
2011.
Kt/V:
Adult HD................ Jan 2011-Dec Jan 2012-Dec 2012.
2011.
Adult PD................ Jan 2011-Dec Jan 2012-Dec 2012.
2011.
Pediatric HD............ Jan 2011-Dec Jan 2012-Dec 2012.
2011.
Hypercalcemia............... Jan 2011-Dec May 2012-Dec 2012.
2011.
------------------------------------------------------------------------
Clinical measures with less than 11 cases for a facility were not
included in that facility's Total Performance Score. Each facility's
Total Performance Score was compared to the estimated minimum Total
Performance Score and the payment reduction table found in section
III.C.11 of this proposed rule. Facilities were required to have a
score on at least one clinical measure to receive a Total Performance
Score. For these simulations, the NHSN Bloodstream Infection in
Hemodialysis Outpatients and Patient Informed Consent for Anemia
Treatment clinical measures, as well as the reporting measures were not
included due to lack of data availability. Therefore, the simulated
facility Total Performance Scores were calculated using only some of
the clinical measure scores.
To estimate the total payment reductions in PY 2016 for each
facility resulting from this proposed rule, we multiplied the total
Medicare payments to the facility during the one year period between
January 2012 and December 2012 by the facility's estimated payment
reduction percentage expected under the ESRD QIP, yielding a total
payment reduction amount for each facility: (Total ESRD payment in
January 2012 through December 2012 times the estimated payment
reduction percentage). For PY 2016 the total payment reduction for all
of the 2,069 facilities expected to receive a reduction is
approximately $26.4 million ($26,355,878). Further, we estimate that
the total costs associated with the collection of information
requirements for PY 2016 described in section VII.B.2 of this proposed
rule would be approximately $15 thousand for all ESRD facilities. As a
result, we estimate that ESRD facilities will experience an aggregate
impact of $26.4 million ($39,486 + $26,355,878= $26,395,364) in PY
2016, as a result of the PY 2016 ESRD QIP.
Table 15 below shows the estimated impact of the finalized ESRD QIP
payment reductions to all ESRD facilities for PY 2016. The table
details the distribution of ESRD facilities by facility size (both
among facilities considered to be small entities and by number of
treatments per facility), geography (both urban/rural and by region),
and by facility type (hospital based/freestanding facilities). Given
that the time periods used for these calculations will differ from
those we propose to use for the PY 2016 ESRD QIP, the actual impact of
the PY 2016 ESRD QIP may vary significantly from the values provided
here.
Table 15--Impact of Proposed QIP Payment Reductions to ESRD Facilities for PY 2016 q
----------------------------------------------------------------------------------------------------------------
Number of Payment
Number of facilities reduction
Number of Medicare Number of expected to (percent
facilities treatments facilities receive a change in
2012 (in with QIP score payment total ESRD
millions) \3\ reduction payments)
----------------------------------------------------------------------------------------------------------------
All Facilities.................. 5,771 38.1 5,486 2,069 -0.35
Facility Type:
Freestanding................ 5,270 35.4 5,116 1,854 -0.32
Hospital-based.............. 501 2.7 370 215 -0.67
Ownership Type:
Large Dialysis.............. 3,769 25.9 3,710 1,228 -0.29
Regional Chain.............. 885 6.1 849 355 -0.36
Independent................. 614 3.9 572 292 -0.52
Hospital-based (non-chain).. 400 2.1 289 169 -0.66
Unknown..................... 103 0.2 66 25 -0.47
Facility Size:
Large Entities.............. 4,654 32.0 4,559 1,583 -0.30
Small Entities \1\.......... 1,014 5.9 861 461 -0.57
Unknown..................... 103 0.2 66 25 -0.47
Urban/Rural Status:
Rural....................... 1,257 6.3 1,191 416 -0.31
Urban....................... 4,514 31.8 4,295 1,653 -0.35
Census Region:
Northeast................... 786 5.8 741 309 -0.40
Midwest..................... 1,325 7.7 1,233 478 -0.37
South....................... 2,501 17.1 2,440 923 -0.34
West........................ 998 7.0 966 302 -0.27
[[Page 40885]]
US Territories \2\.......... 161 0.5 106 57 -0.66
Census Division:
Pacific Rim................. 7 0.1 7 5 -0.92
East North Central.......... 946 5.7 868 354 -0.38
East South Central.......... 477 2.9 465 147 -0.27
Middle Atlantic............. 634 4.6 595 254 -0.42
Mountain.................... 340 1.8 325 82 -0.21
New England................. 170 1.3 154 58 -0.28
Pacific..................... 677 5.2 652 224 -0.30
South Atlantic.............. 1,288 8.8 1,245 490 -0.37
West North Central.......... 416 2.0 383 129 -0.34
West South Central.......... 775 5.5 754 298 -0.34
US Territories \2\.......... 41 0.3 38 28 -0.86
Facility Size ( of
total treatments):
Less than 4,000 treatments.. 1,044 2.6 853 273 -0.36
4,000-9,999 treatments...... 2,157 10.4 2,136 730 -0.30
Over 10,000 treatments...... 2,400 24.7 2,384 1,027 -0.38
Unknown..................... 170 0.4 113 39 -0.41
----------------------------------------------------------------------------------------------------------------
\1\ Small Entities include hospital-based and satellite facilities and non-chain facilities based on DFC self-
reported status.
\2\ Includes Puerto Rico and Virgin Islands.
\3\ Based on claims data through December 2012.
b. Alternatives Considered for the PY 2016 ESRD QIP
In the proposed PY 2016 ESRD QIP, we selected measures that we
believe are important indicators of patient outcomes and quality of
care as discussed in section III.C of this proposed rule. Poor
management of anemia, for example, can lead to avoidable
hospitalizations, decreased quality of life, and death. In order to
provide strong incentives to improve patient outcomes in this
clinically important area, we considered proposing a clinical measure
for Pediatric Iron Therapy. However, upon further review we recognized
that we lacked the necessary baseline data to establish achievement
thresholds, performance standards, and benchmarks. We, therefore,
proposed a reporting measure in order to gather the data we will need
to introduce a clinical measure in the future. In the case of the NHSN
Bloodstream Event in Hemodialysis Outpatient measure, we considered
proposing a reporting measure instead of a clinical measure, because we
lacked the necessary baseline data to establish achievement thresholds,
performance standards, and benchmarks. However, we decided not to do
so. Due to the great impact hospital acquired infections have upon
patients and the industry, we believe it is important to begin
assessing facilities on the number of these events rather than on
merely whether they report these events as soon as possible. Similarly,
in the case of the Patient Informed Consent for Anemia Treatment
measure, we considered proposing a reporting measure instead of a
clinical measure, because we lacked the necessary baseline data to
establish achievement thresholds, performance standards, and
benchmarks. We decided not to do because we believe that providing
counseling on the risks and benefits of anemia treatment, and seeking
informed consent for such treatment, is already a standard of clinical
care in the ESRD provider community. We also considered proposing the
Standardized Hospitalization Ratio Admissions (SHR) measure and the
Standardized Mortality Ratio (SMR) measure as reporting measures for
the PY 2016 ESRD QIP. We decided not to do so due to outstanding
concerns about the measures' validity and reliability. As an
alternative, we proposed the Comorbidity reporting measure to provide a
reliable source of data that we can use to properly risk-adjust SHR and
SMR clinical measures (should we propose to adopt such measures in the
future), and to improve our understanding of the risk factors that
contribute to morbidity and mortality in the ESRD patient population.
In developing the proposed scoring methodology for the PY 2016 ESRD
QIP, we considered several alternatives. For example, we considered
weighting the clinical measures at 80 percent and the reporting
measures at 20 percent of the Total Performance Score. We ultimately
decided to propose the weighting methodology used in the PY 2015 ESRD
QIP because the ratio of clinical to reporting measures did not change
significantly, and also because we wanted to retain a strong incentive
for facilities to meet the requirements for the reporting measures. We
also considered a number of ways to establish achievement thresholds
and benchmarks for the NHSN clinical measure. For example, we
considered using baseline data from CYs 2012 through 2013 to set
achievement thresholds and benchmarks. However, we ultimately decided
to propose to use data from CY 2014 when establishing baseline data for
scoring purposes, because facilities were not required to submit twelve
full months of NHSN data during CY 2012-2013, and rates of healthcare-
acquired infections are susceptible to seasonal variability. In light
of the importance of monitoring and preventing infections in the ESRD
population, we decided that it would be preferable to propose a
clinical measure with equivalent baseline and performance periods,
rather than a reporting measure that would have less of a direct impact
on clinical practice. We also considered a number of ways to score the
Patient Informed Consent for Anemia Treatment clinical measure. In this
case, we lacked baseline data that could be used to establish
achievement thresholds and benchmarks, so we considered proposing a
reporting
[[Page 40886]]
measure in place of the clinical measure. In light of the importance of
the measure, however, we ultimately decided to propose a clinical
measure in order to provide a stronger incentive for facilities to
obtain informed consent from patients receiving anemia treatment. In
considering possible scoring methodologies for the measure, we
specifically considered setting the achievement threshold at 100
percent because we believe that facilities should always obtain
informed consent from patients receiving ESA. However, we recognized
that unexpected events in the clinical setting might preclude the
possibility of obtaining informed consent in every instance, so we
ultimately decided to propose to set the achievement threshold for the
measure at 92 percent. We selected 92 percent because this would allow
facilities with 26 patients to meet the achievement threshold if they
failed to obtain informed consent from 2 patients (see section III.C.8
for more details).
3. DMEPOS Provisions
a. Effects of the Implementation of Fee Schedules for Splints, Casts
and IOLs
The implementation of fee schedules for use in paying claims for
splints, casts, and IOLs inserted in a physician's office would result
in administrative savings associated with determining and implementing
the Medicare allowed payment amounts for these items. As a result, the
agency would save approximately $94,000 in annual administrative
expenses for calculating reasonable charge payment amounts and
maintaining multiple pricing files necessary for making payment on a
reasonable charge basis.
b. Clarification of the 3-Year MLR for DME
We expect no significant impact regarding application of the 3-year
MLR for DME. As we noted in the final regulation for the 3-year MLR, we
believe that a vast majority of the categories of items that were
classified as DME before January 1, 2012, did function for 3 or more
years (76 FR 70289). The 3-year MLR is designed to represent a minimum
threshold for determination of durability for equipment that is
consistent with the statutory DME payment provisions and applies on a
prospective basis, effective January 1, 2012. CMS recognizes that the
healthcare industry and beneficiaries have come to rely on items that
have qualified as DME prior to January 1, 2012, regardless of whether
those items met the 3-year MLR set forth at Sec. 414.202. We note that
given that reliance and consistent with the regulation at Sec.
414.202, CMS will not reopen those prior decisions and reclassify the
equipment in light of the new 3-year standard. We believe that
continuing the Medicare coverage for all the items that qualified as
DME on or prior to January 1, 2012, would avoid disrupting the
continuity of care for the beneficiaries that received these items for
medical treatment prior to January 1, 2012. As noted in the final rule
(76 FR 70301, 70311) it is difficult to predict how many different
types of new devices will be introduced in the market in the future
that may or may not meet the 3-year MLR. However, even absent the 3-
year MLR, it is likely that new products which do not meet the 3-year
MLR will not qualify as DME based upon our current interpretation of
the criteria for DME. It is possible that with the clarification of the
3-year MLR, we will limit what can be covered as DME compared to what
we would have covered as DME absent this regulatory clarification.
Additionally, to the extent the regulatory change is binding to some
new products, there may be reduced program cost. The final rule does
apply to items that were classified as DME on or before January 1, 2012
which tends to lessen the overall impact to the program. In general, we
expect that the final rule (76 FR 70311) and clarification we are now
proposing of the 3-year MLR would have a minimal, if any, savings
impact on the expenditures under program. This is because the vast
majority if items classified as DME in the past have had lifetimes of 3
years or more and so there would be very few instances, if any, where
this clarification will have any impact on classification of items as
DME.
c. Definition of Routinely Purchased DME
As discussed in section IV of this rule, this rule would clarify
the definition of routinely purchased equipment set forth at section
Sec. 414.220(a) and would classify an expensive item of DME or
accessory (over $150) as a capped rental item if it was not acquired by
purchase on a national basis at least 75 percent of the time during the
period July 1986 through June 1987. Because concerns were brought to
our attention on the application of the definition of routinely
purchased DME, we performed a review of the approximately 250 HCPCS
codes assigned to the routinely purchased category of DME in excess of
$150. Based on our review, and given the definition of routinely
purchased equipment set forth at section Sec. 414.220, we would
classify such items in the capped rental category if the items were not
acquired by purchase on a national basis at least 75 percent of the
time during the period July 1986 through June 1987.
As shown in Table 11 of section IV of the preamble, our review
identified 80 current HCPCS codes requiring reclassification from
routinely purchased DME to capped rental DME. The majority of codes
relate to manual wheelchairs and wheelchair accessories. We have
displayed in Column B accessories of complex rehabilitative power
wheelchairs that would be classified as capped rental items and for
which suppliers must also offer to the beneficiary on a lump sum
purchase basis in accordance with Sec. 414.229(h)(3) of the
regulations. In addition, we have displayed in Table 16 below and
Column B of Table 11 of section IV of the preamble approximately 14
codes which would be reclassified in two stages effective July 1, 2016,
rather than January 1, 2014, for all items included in competitive
bidding programs other than those furnished in the Round 1 Recompete
programs and areas; and on January 1, 2017, for those items furnished
as part of the Round I Recompete competitive bidding programs.
Table 16--Items Reclassified to Capped Rental DME Category Effective
July 1, 2016 *
------------------------------------------------------------------------
HCPCS category HCPCS
------------------------------------------------------------------------
Support Surfaces....................... E0197
Walkers................................ E0140 E0149
Wheelchairs Options/Accessories........ E0985 E1020 E1028 E2228 E2368
E2369 E2370 E2375 K0015 K0070
Wheelchair Seating..................... E0955
------------------------------------------------------------------------
* Items furnished in accordance with Round 1 Recompete contracts would
be reclassified effective January 1, 2017.
[[Page 40887]]
In Table 17 below, we show estimated savings associated with making
payment on a capped rental basis rather than a lump sum purchase basis
for items that would be reclassified.
Table 17--Impact of Items Reclassified to Capped Rental DME Category
------------------------------------------------------------------------
Impact to the federal
FY government (in $
millions)
------------------------------------------------------------------------
2014........................................... -20
2015........................................... -20
2016........................................... -20
2017........................................... -30
2018........................................... -40
------------------------------------------------------------------------
The decrease in expenditures is expected because the changes would
eliminate the lump sum purchase method for the certain items, and
instead payment would be made under the monthly rental method resulting
in lower aggregate payments because many beneficiaries do not rent
items for as long as 13 months. In order to prepare our impact on the
Medicare program, we reviewed claims data and utilization for all items
currently classified as capped rental items from 2009 through 2011 and
determined that the weighted average number of allowed monthly rental
services for beneficiaries receiving capped rental items during that
period was 8 months. We therefore used 8 months as the estimated number
of months beneficiaries would rent items in Table 11 of section IV of
the preamble that would not have a purchase option. All anticipated
savings include the price growth for the covered item fee schedule
update factors for DME mandated by section 1834(a)(14) of the Act. In
addition, our estimate takes into account projected changes in DME
beneficiary enrollment. Furthermore, we reflected the savings for these
items that are currently included under any existing competitive
bidding program and which will be reclassified from routinely purchased
to capped rental effective July 1, 2016.
From table 11 of section IV of the preamble above, entitled
Routinely Purchased Items Reclassified to Capped Rental, for items that
would be paid on a capped rental basis with no purchase option, the
highest volume items in terms of 2012 allowed charges are:
Table 18--Three Highest Volume Routinely Purchased Items Reclassified to Capped Rental
----------------------------------------------------------------------------------------------------------------
Allowed
HCPCS Item Purchase fee charges Code added
----------------------------------------------------------------------------------------------------------------
E0760.............................. Ultrasonic Bone Growth $3,514 $21,370,310 1997
Stimulator.
E2510.............................. Speech Generating Device... 7,356 20,170,162 2001
E1161.............................. Tilt In Space Manual 2,571 18,666,674 2003
Wheelchair.
----------------------------------------------------------------------------------------------------------------
The allowed charges in 2012 for these three items combined were
approximately $60 million, which makes up almost half of approximately
$130 million in allowed charges for items that would no longer be
eligible for purchase. Under the capped rental payment rules, these
items would be rented for up to 13-continuous months, following which
title to the equipment would transfer from the supplier to the
beneficiary.
C. Accounting Statement
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/omb/circulars--a004--a-4), in Table 19 below, we
have prepared an accounting statement showing the classification of the
transfers and costs associated with the various provisions of this
proposed rule.
Table 19--Accounting Statement: Classification of Estimated Transfers
and Costs/Savings
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
ESRD PPS for CY 2014
------------------------------------------------------------------------
Annualized Monetized Transfers.......... $-780 million.
From Whom to Whom....................... Federal government to ESRD
providers.
Increased Beneficiary Co-insurance $-190 million.
Payments.
From Whom to Whom....................... Beneficiaries to ESRD
providers.
------------------------------------------------------------------------
ESRD QIP for PY 2016
------------------------------------------------------------------------
Annualized Monetized Transfers.......... -$26.4 million *
From Whom to Whom....................... Federal government to ESRD
providers.
------------------------------------------------------------------------
Category Costs
------------------------------------------------------------------------
Annualized Monetized ESRD Provider Costs $39.5 thousand **
------------------------------------------------------------------------
DME Definition of Routinely Purchased DME
----------------------------------------------------------------------------------------------------------------
Category Transfers
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Transfer -$25.3 million............ 2013 7% 2014-2018
Payments. -$25.7 million............ 2013 3% 2014-2018
---------------------------------------------------------------------------------
From Whom to Whom............. Federal government to Medicare providers.
----------------------------------------------------------------------------------------------------------------
* It is the reduced payment to the ESRD facilities, which fall below the quality standards as stated in section
III.C.11 of this proposed rule.
** It is the cost associated with the collection of information requirements for all ESRD facilities.
[[Page 40888]]
XI. Regulatory Flexibility Act Analysis
The Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354)
(RFA) requires agencies to analyze options for regulatory relief of
small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. Approximately 18 percent of ESRD dialysis
facilities are considered small entities according to the Small
Business Administration's (SBA) size standards, which classifies small
businesses as those dialysis facilities having total revenues of less
than $35.5 million in any 1 year. Individuals and States are not
included in the definitions of a small entity. For more information on
SBA's size standards, see the Small Business Administration's Web site
at https://www.sba.gov/content/small-business-size-standards (Kidney
Dialysis Centers are listed as 621492 with a size standard of $35.5
million).
We do not believe ESRD facilities are operated by small government
entities such as counties or towns with populations of 50,000 or less,
and therefore, they are not enumerated or included in this estimated
RFA analysis. Individuals and States are not included in the definition
of a small entity.
For purposes of the RFA, we estimate that approximately 18 percent
of ESRD facilities are small entities as that term is used in the RFA
(which includes small businesses, nonprofit organizations, and small
governmental jurisdictions). This amount is based on the number of ESRD
facilities shown in the ownership category in Table 12. Using the
definitions in this ownership category, we consider the 614 facilities
that are independent and the 400 facilities that are shown as hospital-
based to be small entities. The ESRD facilities that are owned and
operated by LDOs and regional chains would have total revenues of more
than $35.5 million in any year when the total revenues for all
locations are combined for each business (individual LDO or regional
chain), and are not, therefore, included as small entities.
For the ESRD PPS updates proposed in this rule, a hospital-based
ESRD facility (as defined by ownership type) is estimated to receive a
9.4 percent decrease in payments for CY 2014. An independent facility
(as defined by ownership type) is estimated to receive a 9.5 percent
decrease in payments for CY 2014.
Based on the proposed QIP payment reduction impacts to ESRD
facilities for PY 2016, we estimate that of the 2,069 ESRD facilities
expected to receive a payment reduction, 461 ESRD small entity
facilities would experience a payment reduction (ranging from 0.5
percent up to 2.0 of total payments), as presented in Table 13
(``Estimated Distribution of PY 2016 ESRD QIP Payment Reductions'') and
Table 15 (``Impact of Proposed QIP Payment Reductions to ESRD
Facilities for PY 2016'') above. We anticipate the payment reductions
to average approximately $12,738 per facility among the 2,069
facilities receiving a payment reduction, with an average of $13,810
per small entity facilities receiving a payment reduction. Using our
projections of facility performance, we then estimated the impact of
anticipated payment reductions on ESRD small entities, by comparing the
total payment reductions for the 461 small entities expected to receive
a payment reduction, with the aggregate ESRD payments to all small
entities. We estimate that there are a total of 1,014 small entity
facilities. For this entire group of 1,014 ESRD small entity
facilities, a decrease of 0.57 percent in aggregate ESRD payments is
observed.
Splints, casts and intraocular lenses (IOLs) affected by this rule
are generally furnished by physicians. Approximately 95 percent of
physicians are considered to be small entities for the purposes of the
RFA. Individuals and states are not included in the definition of a
small entity. The reasonable charge payment amounts for splints and
casts are based on national reasonable charge amounts increased each
year by the 12-month percentage change in the CPI-U ending June of the
previous year. These national inflation-indexed charges can easily be
converted to fee schedule amounts with no impact on the national
Medicare payment amounts for these items. Therefore, the fee schedule
amounts that would take effect on January 1, 2014, for splints and
casts would be the same as the reasonable charge amounts that would
take effect on January 1, 2014, for these items. This rule would have
no impact on small businesses that furnish these items. Given that
Medicare pays for very few intraocular lenses inserted in a physician's
office, these entities do not rely on Medicare payment for these items
to support their businesses. Because the fee schedule amounts that
would take effect on January 1, 2014, for intraocular lenses inserted
in a physician's office would be based on the national average allowed
charge for the item, the payment amounts these entities would receive
under the fee schedule will be, on average, the same amounts they are
currently paid for these items when considering the small national
volume of claims as a whole. For example, in 2011, the average allowed
charge for an IOL inserted in a physician's office was $174 for just
287 cases nationwide. If a particular physician office is a small
business that charges less than $174 per IOL, a national fee schedule
amount of $174 could increase payment for this small business for this
item. Alternatively, if a particular physician office is a small
business that charges more than $174 per IOL, a national fee schedule
amount of $174 could decrease payment for this small business for this
item. However, with only 287 cases nationwide, implementing a national
fee of $174 would not have a significant impact on any physician office
that is a small business because the volume of claims indicates that
the small businesses are not relying on payment for these items to fund
their businesses (physician practices) as a whole. Therefore, we expect
that the overall impact of this rule on small businesses that are
physician offices that insert IOLs covered by Medicare would be
minimal. Approximately 85 percent of suppliers of DMEPOS in general are
considered to be small entities for the purposes of the RFA. We expect
that the impact of moving certain expensive DME items from the
routinely purchased payment class to the capped rental payment class on
small business will be minimal since the suppliers would still receive
105 percent of the purchase fee for items that are rented for the full
13-month capped rental period. In addition, the supplier would retain
ownership of equipment that is not used for 13 months and can furnish
the equipment to another beneficiary, beginning a new, separate 13-
month capped rental period for the same item.
Therefore, the Secretary has determined that this proposed rule
will have a significant economic impact on a substantial number of
small entities. We solicit comment on the RFA analysis provided.
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. Any
such regulatory impact 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
a metropolitan statistical area and has fewer than 100 beds. We do not
believe this proposed rule will have a significant impact on
[[Page 40889]]
operations of a substantial number of small rural hospitals because
most dialysis facilities are freestanding. While there are 159 rural
hospital-based dialysis facilities, we do not know how many of them are
based at hospitals with fewer than 100 beds. However, overall, the 159
rural hospital-based dialysis facilities will experience an estimated
10.1 percent decrease in payments. As a result, this proposed rule is
estimated to have a significant impact on small rural hospitals.
Therefore, the Secretary has determined that this proposed rule will
have a significant impact on the operations of a substantial number of
small rural hospitals.
XII. Unfunded Mandates Reform Act Analysis
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Pub. L. 104-4) also requires that agencies assess anticipated costs
and benefits before issuing any rule whose mandates require spending in
any 1 year $100 million in 1995 dollars, updated annually for
inflation. In 2013, that threshold is approximately $141 million. This
proposed rule does not include any mandates that would impose spending
costs on State, local, or Tribal governments in the aggregate, or by
the private sector, of $141 million.
XIII. Federalism Analysis
Executive Order 13132 on Federalism (August 4, 1999) establishes
certain requirements that an agency must meet when it promulgates a
proposed rule (and subsequent final rule) that imposes substantial
direct requirement costs on State and local governments, preempts State
law, or otherwise has Federalism implications. We have reviewed this
proposed rule under the threshold criteria of Executive Order 13132,
Federalism, and have determined that it will not have substantial
direct effects on the rights, roles, and responsibilities of States,
local or Tribal governments.
XIV. Congressional Review Act
This proposed rule 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.
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
XV. Files Available to the Public via the Internet
This section lists the Addenda referred to in the preamble of this
proposed rule. Beginning in CY 2012, the Addenda for the annual ESRD
PPS proposed and final rulemakings will no longer appear in the Federal
Register. Instead, the Addenda will be available only through the
Internet. We will continue to post the Addenda through the Internet.
Readers who experience any problems accessing the Addenda that are
posted on the CMS Web site at https://www.cms.gov/ESRDPayment/PAY/list.asp, should contact Michelle Cruse at (410) 786-7540.
List of Subjects
42 CFR Part 413
Health facilities, Kidney diseases, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 414
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, and 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 follows:
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED
PAYMENT RATES FOR SKILLED NURSING FACILITIES
0
1. The authority citation for part 413 is revised to read as follows:
Authority: Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), and
(n), 1861(v), 1871, 1881, 1883 and 1886 of the Social Security Act
(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 Pub.
L. 106-113 (113 Stat. 1501A-332), sec. 3201 of Pub. L. 112-96 (126
Stat. 156), and sec. 632 of Pub. L. 112-240 (126 Stat. 2354).
Sec. 413.174 [Amended]
0
2. Section 413.174 (f)(6) is amended by removing ``January 1, 2014''
and by adding in its place ``January 1, 2016.
Sec. 413.237 [Amended]
0
3. Section 413.237(a)(1)(iv) is amended by removing ``excluding'' and
by adding in its place ``including''; and by removing ``January 1,
2014'' and adding in its place ``January 1, 2016''.
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
4. The authority citation for part 414 continues to read as follows:
Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).
0
5. The heading for subpart C is revised to read as follows:
Subpart C--Fee Schedules for Parenteral and Enteral Nutrition (PEN)
Nutrients, Equipment and Supplies, Splints, Casts, and Certain
Intraocular Lenses (IOLs)
0
6. Section 414.100 is revised to read as follows:
Sec. 414.100 Purpose.
This subpart implements fee schedules for PEN items and services,
splints and casts, and IOLs inserted in a physician's office as
authorized by section 1842(s) of the Act.
0
7. Section 414.102 is amended by revising paragraphs (a) introductory
text, (a)(2), (b)(1), and (c) to read as follows:
Sec. 414.102 General payment rules.
(a) General rule. For PEN items and services furnished on or after
January 1, 2002, and for splints and casts and IOLs inserted in a
physician's office on or after January 1, 2014, Medicare pays for the
items and services as described in paragraph (b) of this section on the
basis of 80 percent of the lesser of--
* * * * *
(2) The fee schedule amount for the item or service, as determined
in accordance with Sec. Sec. 414.104 thru 414.108.
(b) * * *
(1) CMS or the carrier determines fee schedules for parenteral and
enteral nutrition (PEN) nutrients, equipment, and supplies, splints and
casts, and IOLs inserted in a physician's office, as specified in
Sec. Sec. 414.104 thru 414.108.
* * * * *
(c) Updating the fee schedule amounts. For the years 2003 through
2010 for PEN items and services, the fee schedule amounts of the
preceding year are updated by the percentage increase in the CPI-U for
the 12-month period ending with June of the preceding year. For each
year subsequent to 2010 for PEN items and services and for each year
subsequent to 2014 for splints and casts, and IOLs inserted in a
physician's office, the fee schedule amounts of the preceding year are
updated by the percentage increase in the CPI-U for the 12-month period
ending with June of
[[Page 40890]]
the preceding year, reduced by the productivity adjustment described in
section 1886(b)(3)(B)(xi)(II) of the Act.
0
8. Section 414.106 is added to read as follows:
Sec. 414.106 Splints and casts.
(a) Payment rules. Payment is made in a lump sum for splints and
casts.
(b) Fee schedule amount. The fee schedule amount for payment for an
item or service furnished in 2014 is the reasonable charge amount for
2013, updated by the percentage increase in the CPI-U for the 12-month
period ending with June of 2013.
0
9. Section 414.108 is added to read as follows:
Sec. 414.108 IOLs inserted in a physician's office.
(a) Payment rules. Payment is made in a lump sum for IOLs inserted
in a physician's office.
(b) Fee schedule amount. The fee schedule amount for payment for an
IOL furnished in 2014 is the national average allowed charge for the
IOL furnished from in calendar year 2012, updated by the percentage
increase in the CPI-U for the 24-month period ending with June of 2013.
0
10. Revise the heading to Subpart D to read as follows:
Subpart D--Payment for Durable Medical Equipment, Prosthetic and
Orthotic Devices, and Surgical Dressings
* * * * *
0
11. Section Sec. 414.200 is revised to read as follows:
Sec. 414.200 Purpose.
This subpart implements sections 1834(a), (h) and (i) of the Act by
specifying how payments are made for the purchase or rental of new and
used durable medical equipment, prosthetic and orthotic devices, and
surgical dressings for Medicare beneficiaries.
0
12. Section 414.226 is amended by revising paragraph (c)(6) to read as
follows:
Sec. 414.226 Oxygen and oxygen equipment.
* * * * *
(c) * * *
(6) Beginning in 2008, CMS makes an annual adjustment to the
national limited monthly payment rate for items described in paragraph
(c)(1)(i) of this section to ensure that such payment rates do not
result in expenditures for any year that are more or less than the
expenditures that would have been made if such classes had not been
established.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: June 19, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
Approved: June 26, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2013-16107 Filed 7-1-13; 4:15 pm]
BILLING CODE 4120-01-P
