Federal Register, Volume 79 Issue 129 (Monday, July 7, 2014)

[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Proposed Rules]
[Pages 38366-38420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15736]

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Vol. 79

Monday,

No. 129

July 7, 2014

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 409, 424, 484, et al.

Medicare and Medicaid Programs; CY 2015 Home Health Prospective
Payment System Rate Update; Home Health Quality Reporting Requirements;
and Survey and Enforcement Requirements for Home Health Agencies;
Proposed Rule

Federal Register / Vol. 79 , No. 129 / Monday, July 7, 2014 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 424, 484, 488, 498

[CMS-1611-P]
RIN 0938-AS14

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would update the Home Health Prospective
Payment System (HH PPS) rates, including the national, standardized 60-
day episode payment rates, the national per-visit rates, and the non-
routine medical supply (NRS) conversion factor under the Medicare
prospective payment system for home health agencies (HHAs), effective
January 1, 2015. As required by the Affordable Care Act, this rule
implements the second year of the four-year phase-in of the rebasing
adjustments to the HH PPS payment rates. This rule provides information
on our efforts to monitor the potential impacts of the rebasing
adjustments and the Affordable Care Act mandated face-to-face encounter
requirement. This rule also proposes: Changes to simplify the face-to-
face encounter regulatory requirements; changes to the HH PPS case-mix
weights; changes to the home health quality reporting program
requirements; changes to simplify the therapy reassessment timeframes;
a revision to the Speech-Language Pathology (SLP) personnel
qualifications; minor technical regulations text changes; and
limitations on the reviewability of the civil monetary penalty
provisions. Finally, this proposed rule also discusses Medicare
coverage of insulin injections under the HH PPS, the delay in the
implementation of ICD-10-CM, and solicits comments on a HH value-based
purchasing (HH VBP) model.

DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 2,
2014.

ADDRESSES: In commenting, please refer to file code CMS-1611-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 http://www.regulations.gov. Follow the instructions under
the ``More Search Options'' tab.
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-1611-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1611-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
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,
please call (410) 786-7195 in advance to schedule your arrival with one
of our staff members.
Comments 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: Hillary Loeffler, (410) 786-0456, for
general information about the HH PPS.
Joan Proctor, (410) 786-0949, for information about the HH PPS
Grouper, ICD-9-CM coding, and ICD-10-CM Conversion.
Kristine Chu, (410) 786-8953, for information about rebasing and
the HH PPS case-mix weights.
Hudson Osgood, (410) 786-7897, for information about the HH market
basket.
Caroline Gallaher, (410) 786-8705, for information about the HH
quality reporting program.
Lori Teichman, (410) 786-6684, for information about HHCAHPS.
Peggye Wilkerson, (410) 786-4857, for information about survey and
enforcement requirements for HHAs.
Robert Flemming, (410) 786-4830, for information about the HH VBP
model.
Danielle Shearer, (410) 786-6617, for information about SLP
personnel qualifications.

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: http://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. EST. To schedule an appointment to view public comments,
phone 1-800-743-3951.

Table of Contents

I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Costs and Benefits
II. Background
A. Statutory Background
B. System for Payment of Home Health Services
C. Updates to the HH PPS
III. Provisions of the Proposed Rule
A. Monitoring for Potential Impacts--Affordable Care Act
Rebasing Adjustments and the Face-to-Face Encounter Requirement
1. Affordable Care Act Rebasing Adjustments

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2. Affordable Care Act Face-to-Face Encounter Requirement
B. Proposed Changes to the Face-to-Face Encounter Documentation
Requirements
1. Statutory and Regulatory Requirements
2. Proposed Changes to the Face-to-Face Encounter Narrative
Requirement and Non-Coverage of Associated Physician Certification/
Re-Certification Claims
3. Proposed Clarification on When Documentation of a Face-to-
Face Encounter is Required
C. Proposed Recalibration of the HH PPS Case-Mix Weights
D. CY 2015 Rate Update
1. Proposed CY 2015 Home Health Market Basket Update
2. Home Health Care Quality Reporting Program (HHQRP)
a. General Considerations Used for Selection of Quality Measures
for the HHQRP
b. Background and Quality Reporting Requirements
c. OASIS Data Submission and OASIS Data for Annual Payment
Update
d. Updates to HH QRP Measures Which Are Made as a Result of
Review by the NQF Process
e. Home Health Care CAHPS Survey (HHCAHPS)
3. Proposed CY 2015 Home Health Wage Index
4. Home Health Wage Index
a. Background
b. Update
c. Proposed Implementation of New Labor Market Delineations
5. Proposed CY 2015 Annual Payment Update
a. Background
b. Proposed CY 2015 National, Standardized 60-Day Episode
Payment Rate
c. Proposed CY 2015 National Per-Visit Rates
d. Low-Utilization Payment Adjustment (LUPA) Add-On Factors
e. Proposed CY 2015 Nonroutine Medical Supply Conversion Factor
and Relative Weights
f. Rural Add-On
E. Payments for High-Cost Outliers under the HH PPS
1. Background
2. Fixed Dollar Loss (FDL) Ratio and Loss-Sharing Ratio
F. Medicare Coverage of Insulin Injections under the HH PPS
G. Implementation of the International Classification of
Diseases, 10th Revision, Clinical Modification (ICD-10-CM)
H. Proposed Change to the Therapy Reassessment Timeframes
I. HHA Value-Based Purchasing Model
J. Advancing Health Information Exchange
K. Proposed Revisions to the Speech-Language Pathologist
Personnel Qualifications
L. Proposed Technical Regulations Text Changes
M. Survey and Enforcement Requirements for Home Health Agencies
1. Statutory Background and Authority
2. Reviewability Pursuant to Appeals
3. Technical Adjustment
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
VII. Federalism Analysis
Regulations Text

Acronyms

In addition, because of the many terms to which we refer by
abbreviation in this proposed rule, we are listing these abbreviations
and their corresponding terms in alphabetical order below:

ACH LOS Acute Care Hospital Length of Stay
ADL Activities of Daily Living
APU Annual Payment Update
BBA Balanced Budget Act of 1997, Pub. L. 105-33
BBRA Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999, Pub. L. 106-113
CAD Coronary Artery Disease
CAH Critical Access Hospital
CBSA Core-Based Statistical Area
CASPER Certification and Survey Provider Enhanced Reports
CHF Congestive Heart Failure
CMI Case-Mix Index
CMP Civil Money Penalty
CMS Centers for Medicare & Medicaid Services
CoPs Conditions of Participation
COPD Chronic Obstructive Pulmonary Disease
CVD Cardiovascular Disease
CY Calendar Year
DM Diabetes Mellitus
DRA Deficit Reduction Act of 2005, Pub. L. 109-171, enacted February
8, 2006
FDL Fixed Dollar Loss
FI Fiscal Intermediaries
FR Federal Register
FY Fiscal Year
HAVEN Home Assessment Validation and Entry System
HCC Hierarchical Condition Categories
HCIS Health Care Information System
HH Home Health
HHA Home Health Agency
HHCAHPS Home Health Care Consumer Assessment of Healthcare Providers
and Systems Survey
HH PPS Home Health Prospective Payment System
HHRG Home Health Resource Group
HIPPS Health Insurance Prospective Payment System
ICD-9-CM International Classification of Diseases, Ninth Revision,
Clinical Modification
ICD-10-CM International Classification of Diseases, Tenth Revision,
Clinical Modification
IH Inpatient Hospitalization
IRF Inpatient Rehabilitation Facility
LTCH Long-Term Care Hospital
LUPA Low-Utilization Payment Adjustment
MEPS Medical Expenditures Panel Survey
MMA Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, Pub. L. 108-173, enacted December 8, 2003
MSA Metropolitan Statistical Area
MSS Medical Social Services
NQF National Quality Forum
NRS Non-Routine Supplies
OASIS Outcome and Assessment Information Set
OBRA Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-2-3,
enacted December 22, 1987
OCESAA Omnibus Consolidated and Emergency Supplemental
Appropriations Act, Pub. L. 105-277, enacted October 21, 1998
OES Occupational Employment Statistics
OIG Office of Inspector General
OT Occupational Therapy
OMB Office of Management and Budget
MFP Multifactor productivity
PAMA Protecting Access to Medicare Act of 2014
PAC-PRD Post-Acute Care Payment Reform Demonstration
PEP Partial Episode Payment Adjustment
PT Physical Therapy
QAP Quality Assurance Plan
PRRB Provider Reimbursement Review Board
RAP Request for Anticipated Payment
RF Renal Failure
RFA Regulatory Flexibility Act, Pub. L. 96-354
RHHIs Regional Home Health Intermediaries
RIA Regulatory Impact Analysis
SAF Standard Analytic File
SLP Speech-Language Pathology
SN Skilled Nursing
SNF Skilled Nursing Facility
UMRA Unfunded Mandates Reform Act of 1995.

I. Executive Summary

A. Purpose

This proposed rule would update the payment rates for HHAs for
calendar year (CY) 2015, as required under section 1895(b) of the
Social Security Act (the Act). This would reflect the second year of
the four-year phase-in of the rebasing adjustments to the national,
standardized 60-day episode payment rate, the national per-visit rates,
and the NRS conversion factor finalized in the CY 2014 HH PPS final
rule (78 FR 72256), required under section 3131(a) of the Patient
Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as
amended by the Health Care and Education Reconciliation Act of 2010
(Pub. L. 111-152) (collectively referred to as the ``Affordable Care
Act''). Updates to payment rates under the HH PPS would also include a
proposal to change the home health wage index to incorporate the new
Office of Management and Budget (OMB) core-based statistical area
(CBSA) definitions and updates to the payment rates by the home health
payment update percentage, which would reflect the productivity
adjustment mandated by 3401(e) of the Affordable Care Act.
This proposed rule also discusses: Our efforts to monitor the
potential

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impacts of the Affordable Care Act mandated rebasing adjustments and
the face-to-face encounter requirement (sections 3131(a) and 6407,
respectively, of the Affordable Care Act); coverage of insulin
injections under the HH PPS; and the delay in the implementation of the
International Classification of Diseases, 10th Edition, Clinical
Modification (ICD-10-CM) as a result of recent Congressional action
(section 212 of the Protecting Access to Medicare Act, Public Law 113-
93 (``PAMA'')). This proposed rule also proposes changes to simplify
the regulations at Sec. 424.22(a)(1)(v) that govern the face-to-face
encounter requirement mandated by section 6407 of the Affordable Care
Act; changes to the HH PPS case-mix weights under section
1895(b)(4)(A)(i) and (b)(4)(B) of the Act; changes to the home health
quality reporting program requirements under section
1895(b)(3)(B)(v)(II) of the Act; changes to simplify the therapy
reassessment timeframes specified in regulation at Sec.
409.44(c)(2)(C) and (D); a revision to the personnel qualifications for
SLP at Sec. 484.4; and minor technical regulations text changes at
Sec. 424.22(b)(1) and Sec. 484.250(a)(1). This proposed rule would
also place limitations on the reviewability of CMS's decision to impose
a civil monetary penalty for noncompliance with federal participation
requirements. Finally, the proposed rule discusses and solicits
comments on a HH VBP model.

B. Summary of the Major Provisions

As required by section 3131(a) of the Affordable Care Act and
finalized in the CY 2014 HH final rule, ``Medicare and Medicaid
Programs; Home Health Prospective Payment System Rate Update for CY
2014, Home Health Quality Reporting Requirements, and Cost Allocation
of Home Health Survey Expenses'' (78 FR 77256, December 2, 2013), we
are implementing the second year of the four-year phase-in of the
rebasing adjustments to the national, standardized 60-day episode
payment amount, the national per-visit rates and the NRS conversion
factor in section III.D.4. The rebasing adjustments for CY 2015 would
reduce the national, standardized 60-day episode payment amount by
$80.95, increase the national per-visit payment amounts by 3.5 percent
of the national per-visit payment amounts in CY 2010 with the increases
ranging from $6.34 for medical social services to $1.79 for home health
aide services as described in section III.A, and reduce the NRS
conversion factor by 2.82 percent.
This proposed rule also discusses our efforts to monitor the
potential impacts of the rebasing adjustments and the Affordable Care
Act mandated face-to-face encounter requirement in section III.A and,
in section III.B. We would propose changes to the face-to-face
encounter narrative requirement. In addition, we are proposing that
associated physician claims for certification/re-certification of
eligibility (patient not present) not be eligible to be paid when a
patient does not meet home health eligibility criteria. We would also
clarify in sub-regulatory guidance when the face-to-face encounter
requirement would be applicable. In section III.C, we are proposing to
recalibrate the HH PPS case-mix weights, using the most current cost
and utilization data available, in a budget neutral manner. In section
III.D.1, we propose to update the payment rates under the HH PPS by the
home health payment update percentage of 2.2 percent (using the 2010-
based Home Health Agency (HHA) market basket update of 2.6 percent,
minus a 0.4 percentage point reduction for productivity as required by
1895(b)(3)(B)(vi)(I) of the Act. In section III.D.3, we propose to
update the home health wage index using a 50/50 blend of the existing
core-based statistical area (CBSA) designations and the new CBSA
designations outlined in a February 28, 2013, Office of Management and
Budget (OMB) bulletin, respectively. In section III.E, we propose no
changes to the fixed-dollar loss (FDL) and loss-sharing ratios used in
calculating high-cost outlier payments under the HH PPS.
This proposed rule also proposes changes to the home health quality
reporting program in section III.D.2, including the establishment of a
minimum threshold for submission of OASIS assessments for purposes of
quality reporting compliance, the establishment of a policy for the
adoption of changes to measures that occur in-between rulemaking cycles
as a result of the NQF process, and submission dates for the HHCAHPS
Survey moving forward through CY 2017. In section III.F, we discuss
recent analysis of home health claims identified with skilled nursing
visits likely done for the sole purpose of insulin injection
assistance, and the lack of any secondary diagnoses on the home health
claim to support that the patient was physically or mentally unable to
self-inject. We discuss, in section III.G, the delay in the
implementation of ICD-10-CM as a result of section 212 of PAMA. In
section III.H we seek to simplify the therapy reassessment regulations
by proposing that therapy reassessments are to occur every 14 calendar
days rather than before the 14th and 20th visits and once every 30
calendar days. Finally, in section III.I, we plan to discuss and
solicit comments on an HH VBP model; in section III.J, we propose to
revise the personnel qualifications for SLP; in section III.K we are
proposing minor technical regulations text changes; and in section
III.L we are proposing to place limitations on the reviewability of the
civil monetary penalty that is imposed on a HHA for noncompliance with
federal participation requirements.

C. Summary of Costs and Transfers

Table 1--Summary of Costs and Transfers
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Provision Description Costs Transfers
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CY 2015 HH PPS Payment Rate A net reduction in The overall economic
Update. burden of $21.55 impact of this
million associated proposed rule is an
with certifying estimated $58
patient eligibility million in
for home health decreased payments
services & to HHAs.
certification form
revisions.
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II. Background

A. Statutory Background

The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted
August 5, 1997), significantly changed the way Medicare pays for
Medicare HH services. Section 4603 of the BBA mandated the development
of the HH PPS. Until the implementation of the HH PPS on October 1,
2000, HHAs received payment under a retrospective reimbursement system.
Section 4603(a) of the BBA mandated the development of a HH PPS for
all Medicare-covered HH services provided under a plan of care (POC)
that were paid on a reasonable cost basis by adding section 1895 of the
Social Security Act (the Act), entitled ``Prospective Payment For Home
Health Services.'' Section 1895(b)(1) of the Act requires the Secretary
to establish a HH

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PPS for all costs of HH services paid under Medicare.
Section 1895(b)(3)(A) of the Act requires the following: (1) The
computation of a standard prospective payment amount include all costs
for HH services covered and paid for on a reasonable cost basis and
that such amounts be initially based on the most recent audited cost
report data available to the Secretary; and (2) the standardized
prospective payment amount be adjusted to account for the effects of
case-mix and wage levels among HHAs.
Section 1895(b)(3)(B) of the Act addresses the annual update to the
standard prospective payment amounts by the HH applicable percentage
increase. Section 1895(b)(4) of the Act governs the payment
computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act
require the standard prospective payment amount to be adjusted for
case-mix and geographic differences in wage levels. Section
1895(b)(4)(B) of the Act requires the establishment of an appropriate
case-mix change adjustment factor for significant variation in costs
among different units of services.
Similarly, section 1895(b)(4)(C) of the Act requires the
establishment of wage adjustment factors that reflect the relative
level of wages, and wage-related costs applicable to HH services
furnished in a geographic area compared to the applicable national
average level. Under section 1895(b)(4)(C) of the Act, the wage-
adjustment factors used by the Secretary may be the factors used under
section 1886(d)(3)(E) of the Act.
Section 1895(b)(5) of the Act gives the Secretary the option to
make additions or adjustments to the payment amount otherwise paid in
the case of outliers due to unusual variations in the type or amount of
medically necessary care. Section 3131(b)(2) of the Patient Protection
and Affordable Care Act of 2010 (the Affordable Care Act) (Pub. L. 111-
148, enacted March 23, 2010) revised section 1895(b)(5) of the Act so
that total outlier payments in a given year would not exceed 2.5
percent of total payments projected or estimated. The provision also
made permanent a 10 percent agency-level outlier payment cap.
In accordance with the statute, as amended by the BBA, we published
a final rule in the July 3, 2000 Federal Register (65 FR 41128) to
implement the HH PPS legislation. The July 2000 final rule established
requirements for the new HH PPS for HH services as required by section
4603 of the BBA, as subsequently amended by section 5101 of the Omnibus
Consolidated and Emergency Supplemental Appropriations Act (OCESAA) for
Fiscal Year 1999, (Pub. L. 105-277, enacted October 21, 1998); and by
sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP
Balanced Budget Refinement Act (BBRA) of 1999, (Pub. L. 106-113,
enacted November 29, 1999). The requirements include the implementation
of a HH PPS for HH services, consolidated billing requirements, and a
number of other related changes. The HH PPS described in that rule
replaced the retrospective reasonable cost-based system that was used
by Medicare for the payment of HH services under Part A and Part B. For
a complete and full description of the HH PPS as required by the BBA,
see the July 2000 HH PPS final rule (65 FR 41128 through 41214).
Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L.
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v)
to the Act, requiring HHAs to submit data for purposes of measuring
health care quality, and links the quality data submission to the
annual applicable percentage increase. This data submission requirement
is applicable for CY 2007 and each subsequent year. If an HHA does not
submit quality data, the HH market basket percentage increase is
reduced by 2 percentage points. In the November 9, 2006 Federal
Register (71 FR 65884, 65935), we published a final rule to implement
the pay-for-reporting requirement of the DRA, which was codified at
Sec. 484.225(h) and (i) in accordance with the statute. The pay-for-
reporting requirement was implemented on January 1, 2007.
The Affordable Care Act made additional changes to the HH PPS. One
of the changes in section 3131 of the Affordable Care Act is the
amendment to section 421(a) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173,
enacted on December 8, 2003) as amended by section 5201(b) of the DRA.
The amended section 421(a) of the MMA now requires, for HH services
furnished in a rural area (as defined in section 1886(d)(2)(D) of the
Act) with respect to episodes and visits ending on or after April 1,
2010, and before January 1, 2016, that the Secretary increase, by 3
percent, the payment amount otherwise made under section 1895 of the
Act.

B. System for Payment of Home Health Services

Generally, Medicare makes payment under the HH PPS on the basis of
a national standardized 60-day episode payment rate that is adjusted
for the applicable case-mix and wage index. The national standardized
60-day episode rate includes the six HH disciplines (skilled nursing,
HH aide, physical therapy, speech-language pathology, occupational
therapy, and medical social services). Payment for non-routine supplies
(NRS) is no longer part of the national standardized 60-day episode
rate and is computed by multiplying the relative weight for a
particular NRS severity level by the NRS conversion factor (See section
II.D.4.e). Payment for durable medical equipment covered under the HH
benefit is made outside the HH PPS payment system. To adjust for case-
mix, the HH PPS uses a 153-category case-mix classification system to
assign patients to a home health resource group (HHRG). The clinical
severity level, functional severity level, and service utilization are
computed from responses to selected data elements in the OASIS
assessment instrument and are used to place the patient in a particular
HHRG. Each HHRG has an associated case-mix weight which is used in
calculating the payment for an episode.
For episodes with four or fewer visits, Medicare pays national per-
visit rates based on the discipline(s) providing the services. An
episode consisting of four or fewer visits within a 60-day period
receives what is referred to as a low-utilization payment adjustment
(LUPA). Medicare also adjusts the national standardized 60-day episode
payment rate for certain intervening events that are subject to a
partial episode payment adjustment (PEP adjustment). For certain cases
that exceed a specific cost threshold, an outlier adjustment may also
be available.

C. Updates to the HH PPS

As required by section 1895(b)(3)(B) of the Act, we have
historically updated the HH PPS rates annually in the Federal Register.
The August 29, 2007 final rule with comment period set forth an update
to the 60-day national episode rates and the national per-visit rates
under the HH PPS for CY 2008. The CY 2008 HH PPS final rule included an
analysis performed on CY 2005 HH claims data, which indicated a 12.78
percent increase in the observed case-mix since 2000. Case-mix
represents the variations in conditions of the patient population
served by the HHAs. Subsequently, a more detailed analysis was
performed on the 2005 case-mix data to evaluate if any portion of the
12.78 percent increase was associated with a change in the actual
clinical condition of HH patients. We

[[Page 38370]]

examined data on demographics, family severity, and non-HH Part A
Medicare expenditures to predict the average case-mix weight for 2005.
We identified 8.03 percent of the total case-mix change as real, and
therefore, decreased the 12.78 percent of total case-mix change by 8.03
percent to get a final nominal case-mix increase measure of 11.75
percent (0.1278 * (1 - 0.0803) = 0.1175).
To account for the changes in case-mix that were not related to an
underlying change in patient health status, we implemented a reduction,
over 4 years, to the national, standardized 60-day episode payment
rates. That reduction was to be 2.75 percent per year for 3 years
beginning in CY 2008 and 2.71 percent for the fourth year in CY 2011.
In the CY 2011 HH PPS final rule (76 FR 68532), we updated our analyses
of case-mix change and finalized a reduction of 3.79 percent, instead
of 2.71 percent, for CY 2011 and deferred finalizing a payment
reduction for CY 2012 until further study of the case-mix change data
and methodology was completed.
In the CY 2012 HH PPS final rule (76 FR 68526), we updated the 60-
day national episode rates and the national per-visit rates. In
addition, as discussed in the CY 2012 HH PPS final rule (76 FR 68528),
our analysis indicated that there was a 22.59 percent increase in
overall case-mix from 2000 to 2009 and that only 15.76 percent of that
overall observed case-mix percentage increase was due to real case-mix
change. As a result of our analysis, we identified a 19.03 percent
nominal increase in case-mix. At that time, to fully account for the
19.03 percent nominal case-mix growth identified from 2000 to 2009, we
finalized a 3.79 percent payment reduction in CY 2012 and a 1.32
percent payment reduction for CY 2013.
In the CY 2013 HH PPS final rule (77 FR 67078), we implemented a
1.32 percent reduction to the payment rates for CY 2013 to account for
nominal case-mix growth from 2000 through 2010. When taking into
account the total measure of case-mix change (23.90 percent) and the
15.97 percent of total case-mix change estimated as real from 2000 to
2010, we obtained a final nominal case-mix change measure of 20.08
percent from 2000 to 2010 (0.2390 * (1 - 0.1597) = 0.2008). To fully
account for the remainder of the 20.08 percent increase in nominal
case-mix beyond that which was accounted for in previous payment
reductions, we estimated that the percentage reduction to the national,
standardized 60-day episode rates for nominal case-mix change would be
2.18 percent. Although we considered proposing a 2.18 percent reduction
to account for the remaining increase in measured nominal case-mix, we
finalized the 1.32 percent payment reduction to the national,
standardized 60-day episode rates in the CY 2012 HH PPS final rule (76
FR 68532).
Section 3131(a) of the Affordable Care Act requires that, beginning
in CY 2014, CMS apply an adjustment to the national, standardized 60-
day episode rate and other amounts that reflect factors such as changes
in the number of visits in an episode, the mix of services in an
episode, the level of intensity of services in an episode, the average
cost of providing care per episode, and other relevant factors.
Additionally, CMS must phase in any adjustment over a four-year period
in equal increments, not to exceed 3.5 percent of the amount (or
amounts) as of the date of enactment of the Affordable Care Act, and
fully implement the rebasing adjustments by CY 2017. The statute
specifies that the maximum rebasing adjustment is to be no more than
3.5 percent per year of the CY 2010 rates. Therefore, in the CY 2014 HH
PPS final rule (78 FR 72256) for each year, CY 2014 through CY 2017, we
finalized a fixed-dollar reduction to the national, standardized 60-day
episode payment rate of $80.95 per year, increases to the national per-
visit payment rates per year as reflected in Table 2, and a decrease to
the NRS conversion factor of 2.82 percent per year. We also finalized
three separate LUPA add-on factors for skilled nursing, physical
therapy, and speech-language pathology and removed 170 diagnosis codes
from assignment to diagnosis groups in the HH PPS Grouper.

Table 2--Maximum Adjustments to the National Per-Visit Payment Rates
[Not to exceed 3.5 percent of the amount(s) in CY 2010]
------------------------------------------------------------------------
Maximum
2010 National per- adjustments per
visit payment year (CY 2014
rates through CY 2017)
------------------------------------------------------------------------
Skilled Nursing................... $113.01 $3.96
Home Health Aide.................. 51.18 1.79
Physical Therapy.................. 123.57 4.32
Occupational Therapy.............. 124.40 4.35
Speech-Language Pathology......... 134.27 4.70
Medical Social Services........... 181.16 6.34
------------------------------------------------------------------------

III. Provisions of the Proposed Rule

A. Monitoring for Potential Impacts--Affordable Care Act Rebasing
Adjustments and the Face-to-Face Encounter Requirement

1. Affordable Care Act Rebasing Adjustments
As stated in the CY 2014 HH PPS final rule, we plan to monitor
potential impacts of rebasing. Although we do not have enough CY 2014
home health claims data to analyze as part of our effort in monitoring
the potential impacts of the rebasing adjustments finalized in the CY
2014 HH PPS final rule (78 FR 72293), we have analyzed 2012 home health
agency cost report data to determine whether the average cost per
episode was higher using 2012 cost report data compared to the 2011
cost report data used in calculating the rebasing adjustments.
Specifically, we re-estimated the cost of a 60-day episode using 2012
cost report and 2012 claims data, rather than using 2011 cost report
and 2012 claims data. To determine the 2012 average cost per visit per
discipline, we applied the same trimming methodology outlined in the CY
2014 HH PPS proposed rule (78 FR 40284) and weighted the costs per
visit from the 2012 cost reports by size,

[[Page 38371]]

facility type, and urban/rural location so the costs per visit were
nationally representative. The 2012 average number of visits was taken
from 2012 claims data. We estimate the cost of a 60-day episode to be
$2,413.82 using 2012 cost report data (Table 3).

Table 3--Average Costs per Visit and Average Number of Visits for a 60-Day Episode
----------------------------------------------------------------------------------------------------------------
2012 Average 2012 Average 2012 60-day
Discipline costs per visit number of visits episode costs
----------------------------------------------------------------------------------------------------------------
Skilled Nursing........................................ $130.49 9.55 $1,246.18
Home Health Aide....................................... 61.62 2.60 160.21
Physical Therapy....................................... 160.03 4.80 768.14
Occupational Therapy................................... 157.78 1.09 171.98
Speech-Language Pathology.............................. 172.08 0.22 37.86
Medical Social Services................................ 210.36 0.14 29.45
--------------------------------------------------------
Total.............................................. ................. ................. 2,413.82
----------------------------------------------------------------------------------------------------------------
Source: FY 2012 Medicare cost report data and 2012 Medicare claims data from the standard analytic file (as of
June 2013) for episodes ending on or before December 31, 2012 for which we could link an OASIS assessment.

Using the most current claims data--CY 2013 data (as of December
31, 2013), we re-examined the 2012 visit distribution and re-calculated
the 2013 estimated cost per episode using the updated 2013 visit
profile. We estimate the 2013 60-day episode cost to be $2,477.01(Table
4).

Table 4--2013 Estimated Cost per Episode
----------------------------------------------------------------------------------------------------------------
2012 Average 2013 Average 2013 Estimated
Discipline costs per number of 2013 HH market cost per
visit visits basket episode
----------------------------------------------------------------------------------------------------------------
Skilled Nursing................................. $130.49 9.30 1.023 $1,241.47
Home Health Aide................................ 61.62 2.42 1.023 152.55
Physical Therapy................................ 160.03 4.99 1.023 816.92
Occupational Therapy............................ 157.78 1.20 1.023 193.69
Speech-Language Pathology....................... 172.08 0.24 1.023 42.25
Medical Social Services......................... 210.36 0.14 1.023 30.13
---------------------------------------------------------------
Total....................................... .............. .............. .............. 2,477.01
----------------------------------------------------------------------------------------------------------------
Source: FY 2012 Medicare cost report data and 2013 Medicare claims data from the standard analytic file (as of
December 2013) for episodes ending on or before December 31, 2013 for which we could link an OASIS assessment.

In the CY 2014 HH PPS final rule (78 FR 72277), using 2011 cost
report data, we estimated the 2012 60-day episode cost to be about
$2,507.83 ($2,453.71 * 0.9981 * 1.024) and the 2013 60-day episode cost
to be $2,565.51 ($2,453.71 * 0.9981 * 1.024 * 1.023). Using 2012 cost
report data, the 2012 and 2013 estimated cost per episode ($2,413.82
and $2,477.01, respectively) are lower than the episode costs we
estimated using 2011 cost report data for the CY 2014 HH PPS final
rule. We note that the proposed CY 2015 national, standardized 60-day
episode payment rate is $2,922.76 as described in section III.D.4. of
this proposed rule.
In the CY 2014 HH PPS final rule, we stated that our analysis of
2011 cost report data and 2012 claims data indicated a need for a -3.45
percent rebasing adjustment to the national, standardized 60-day
episode payment rate each year for four years. However, as specified by
statute, the rebasing adjustment is limited to 3.5 percent of the CY
2010 national, standardized 60-day episode payment rate of $2,312.94
(74 FR 58106), or $80.95. We stated that given that a -3.45 percent
adjustment for CY 2014 through CY 2017 would result in larger dollar
amount reductions than the maximum dollar amount allowed under section
3131(a) of the Affordable Care Act of $80.95, we are limited to
implementing a reduction of $80.95 (approximately 2.8 percent) to the
national, standardized 60-day episode payment amount each year for CY
2014 through CY 2017. Our latest analysis of 2012 cost report data
suggests that an even larger reduction (4.29 percent) than the
reduction described in the CY 2014 final rule (3.45 percent) would be
needed in order to align payments to costs. We will continue to monitor
potential impacts of rebasing.
2. Affordable Care Act Face-to-Face Encounter Requirement
Effective January 1, 2011, section 6407 the Affordable Care Act
requires that as a condition for payment, prior to certifying a
patient's eligibility for the Medicare home health benefit, the
physician must document that the physician himself or herself, or an
allowed nonphysician practitioner (NPP), as described below, had a
face-to-face encounter with the patient. The regulations at
424.22(a)(1)(v) currently require that that the face-to-face encounter
be related to the primary reason the patient requires home health
services and occur no more than 90 days prior to the home health start
of care date or within 30 days of the start of the home health care. In
addition, as part of the certification of eligibility, the certifying
physician must document the date of the encounter and include an
explanation (narrative) of why the clinical findings of such encounter
support that the patient is homebound, as defined in subsections
1814(a) and 1835(a) of the Act, and in need of either intermittent
skilled nursing services or therapy services, as defined in Sec.
409.42(c). The face-to-face encounter requirement was enacted, in part,
to discourage physicians certifying patient eligibility for the
Medicare home health benefit from relying solely on

[[Page 38372]]

information provided by the HHAs when making eligibility determinations
and other decisions about patient care.
In the CY 2011 HH PPS final rule, in which we implemented the face-
to-face encounter provision of the Affordable Care Act, some commenters
expressed concern that this requirement would diminish access to home
health services (75 FR 70427). We examined home health claims data from
before implementation of the face-to-face encounter requirement (CY
2010), the year of implementation (CY 2011), and the years following
implementation (CY 2012 and CY 2013), to determine whether there were
indications of access issues as a result of this requirement.
Nationally, utilization held relatively constant between CY 2010 and CY
2011 and decreased slightly in CY 2012 (see Table 5). While Table 5
contains preliminary CY 2013 data, the discussion in this section will
focus mostly on CY 2010 through CY 2012 data. We will update our
analysis with complete CY 2013 data in the final rule. Between CY 2010
and CY 2011, there was a 0.81 percent decrease in number of episodes,
and a 1.37 percent decrease in the number of episodes between CY 2011
and CY 2012. However, there was a 0.51 percent increase in the number
of beneficiaries with at least one home health episode between CY 2010
and CY 2011 and between CY 2011 and CY 2012 the number of beneficiaries
with at least one episode held relatively constant. Home health users
(beneficiaries with at least one home health episode) as a percentage
of Part A and/or Part B fee-for-service (FFS) beneficiaries decreased
slightly from 9.3 percent in CY 2010 to 9.2 percent in CY 2011to 9.0
percent in CY 2012 and the number of episodes per Part A and/or Part B
FFS beneficiaries decreased slightly between CY 2010 and CY 2011, but
remained relatively constant 0.18 or 18 episodes per 100 Medicare Part
A FFS beneficiaries for CY 2012). We note these observed decreases
between CY 2010 and CY 2012, for the most part, are likely the result
of increases in FFS enrollment between CY 2010 and CY 2012. Newly
eligibly Medicare beneficiaries are typically not of the age where home
health services are needed and therefore, without any changes in
utilization, we would expect home health users and the number of
episodes per Part A and/or B FFS beneficiaries to decrease with an
increase in the number of newly enrolled FFS beneficiaries. The number
of HHAs providing at least one home health episode increased steadily
from CY 2010 through CY 2013 (see Table 5).

Table 5--Home Health Statistics, CY 2010 Through CY 2013
----------------------------------------------------------------------------------------------------------------
2013
2010 2011 2012 (Preliminary)
----------------------------------------------------------------------------------------------------------------
Number of episodes.............................. 6,833,669 6,821,459 6,727,875 6,600,631
Beneficiaries receiving at least 1 episode (Home 3,431,696 3,449,231 3,446,122 3,432,571
Health Users)..................................
Part A and/or B FFS beneficiaries............... 36,818,078 37,686,526 38,224,640 38,501,512
Episodes per Part A and/or B FFS beneficiaries.. 0.19 0.18 0.18 0.17
Home health users as a percentage of Part A and/ 9.3% 9.2% 9.0% 8.9%
or B FFS beneficiaries.........................
HHAs providing at least 1 episode............... 10,916 11,446 11,746 11,820
----------------------------------------------------------------------------------------------------------------
Source: National claims history (NCH) data obtained from Chronic Condition Warehouse (CCW)--Accessed on May 14,
2014. Medicare enrollment information obtained from the CCW Master Beneficiary Summary File. Beneficiaries are
the total number of beneficiaries in a given year with at least 1 month of Part A or Part B Fee For Service
Coverage without having any months of Medicare Advantage Coverage.
Note(s): These results include all episode types (Normal, PEP, Outlier, LUPA) and also include episodes from
outlying areas (outside of 50 States and District of Columbia). Only episodes with a through date in the year
specified are included. Episodes with a claim frequency code equal to ``0'' (``Non-payment/zero claims'') and
``2'' (``Interim--first claim'') are excluded. If a beneficiary is treated by providers from multiple states
within a year the beneficiary is counted within each state's unique number of beneficiaries served.

Although home health utilization at the national level appears to
have held relatively constant between CY 2010 and CY 2011 with a slight
decrease in utilization in CY 2012, the decrease in utilization in CY
2012 did not occur in all states. For example, the number of episodes
increased between CY 2010 and CY 2011 and again, in some instances,
between CY 2011 and CY 2012 in Alabama, California, and Virginia, to
name a few. The number of episodes per Part A and/or Part B FFS
beneficiaries for these states also remained roughly the same between
CY 2010 through CY 2012 (see Table 6).

Table 6--Home Health Statistics for Select States With Increasing Numbers of Home Health Episodes, CY 2010 Through CY 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year AL CA MA NJ VA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Episodes............................................. 2010 149,242 428,491 183,271 142,328 142,660
2011 151,131 451,749 186,849 143,127 149,154
2012 151,812 477,732 183,625 142,129 154,677
Beneficiaries Receiving at Least 1 Episode (Home Health Users). 2010 68,949 259,013 103,954 95,804 83,933
2011 70,539 270,259 107,520 97,190 86,796
2012 71,186 281,023 106,910 96,534 89,879
Part A and/or Part B FFS Beneficiaries......................... 2010 689,302 3,199,845 890,472 1,205,049 1,014,248
2011 717,413 3,294,574 934,312 1,228,239 1,055,516
2012 732,952 3,397,936 959,015 1,232,950 1,086,474
Episodes per Part A and/or Part B FFS beneficiaries............ 2010 0.22 0.13 0.21 0.12 0.14
2011 0.21 0.14 0.20 0.12 0.14
2012 0.21 0.14 0.19 0.12 14
Home Health Users as a Percentage of Part A and/or B FFS 2010 10.00% 8.09% 11.67% 7.95% 8.28%
beneficiaries.................................................

[[Page 38373]]

2011 9.83% 8.20% 11.51% 7.91% 8.22%
2012 9.71% 8.27% 11.15% 7.83% 8.27%
Providers Providing at Least 1 Episode......................... 2010 148 925 138 49 196
2011 150 1,013 150 48 209
2012 148 1,073 160 47 219
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: National claims history (NCH) data obtained from Chronic Condition Warehouse (CCW)--Accessed on May 14, 2014. Medicare enrollment information
obtained from the CCW Master Beneficiary Summary File. Beneficiaries are the total number of beneficiaries in a given year with at least 1 month of
Part A or Part B Fee For Service Coverage without having any months of Medicare Advantage Coverage.
Note(s): These results include all episode types (Normal, PEP, Outlier, LUPA) and also include episodes from outlying areas (outside of 50 States and
District of Columbia). Only episodes with a through date in the year specified are included. Episodes with a claim frequency code equal to ``0''
(``Non-payment/zero claims'') and ``2'' (``Interim--first claim'') are excluded. If a beneficiary is treated by providers from multiple states within
a year the beneficiary is counted within each state's unique number of beneficiaries served.

In general, between CY 2010 and CY 2012 the number of episodes for
states with the highest utilization of Medicare home health (as
measured by the number of episodes per Part A and/or Part B FFS
beneficiary) decreased; however, even with this decrease between CY
2010 and CY 2012, the five states listed in Table 7 continue to be
among the states with the highest utilization of Medicare home health
nationally (see Figure 1). If we were to exclude the five states listed
in Table 7 from the national figures in Table 5, home health users
(beneficiaries with at least one home health episode) as a percentage
of Part A and/or Part B fee-for-service (FFS) beneficiaries would
decrease from to 9.0 percent to 8.1 percent for CY 2012 and the number
of episodes per Part A and/or Part B FFS beneficiaries would decrease
from 0.18 (or 18 episodes per 100 Medicare Part A and/or Part B FFS
beneficiaries) to 0.14 (or 14 episodes per 100 Medicare Part A and/or
Part B FFS beneficiaries) for CY 2012. We also note that two of the
states with the greatest number of home health episodes per Part A and/
or Part B FFS beneficiaries (Table 7 and Figure 1) have areas with
suspect billing practices. Moratoria on enrollment of new HHAs,
effective January 30, 2014, were put in place for: Miami, FL; Chicago,
IL; Fort Lauderdale, FL; Detroit, MI; Dallas, TX; and Houston, TX.

Table 7--Home Health Statistics for the States With the Highest Number of Home Health Episodes per Part A and/or Part B FFS Beneficiaries, CY 2010
Through CY 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year TX FL OK MS LA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Episodes............................................. 2010 1,127,852 689,183 208,555 153,169 256,014
2011 1,107,605 701,426 203,112 153,983 249,479
2012 1,054,244 691,255 196,887 148,516 230,115
Beneficiaries Receiving at Least 1 Episode (Home Health Users). 2010 366,844 355,181 68,440 55,132 77,976
2011 363,474 355,900 67,218 55,818 77,677
2012 350,803 354,838 65,948 55,438 74,755
Part A and/or Part B FFS Beneficiaries......................... 2010 2,500,237 2,422,141 533,792 465,129 544,555
2011 2,597,406 2,454,124 549,687 476,497 561,531
2012 2,604,458 2,451,790 558,500 480,218 568,483
Episodes per Part A and/or Part B FFS beneficiaries............ 2010 0.45 0.28 0.39 0.33 0.47
2011 0.43 0.29 0.37 0.32 0.44
2012 0.40 0.28 0.35 0.31 0.40
Home Health Users as a Percentage of Part A and/or Part B FFS 2010 14.67% 14.66% 12.82% 11.85% 14.32%
Beneficiaries.................................................
2011 13.99% 14.50% 12.23% 11.71% 13.83%
2012 13.47% 14.47% 11.81% 11.54% 13.15%
Providers Providing at Least 1 Episode......................... 2010 2,352 1,348 240 53 213
2011 2,472 1,426 252 51 216
2012 2,549 1,430 254 48 213
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: National claims history (NCH) data obtained from Chronic Condition Warehouse (CCW)--Accessed on May 14, 2014. Medicare enrollment information
obtained from the CCW Master Beneficiary Summary File. Beneficiaries are the total number of beneficiaries in a given year with at least 1 month of
Part A or Part B Fee For Service Coverage without having any months of Medicare Advantage Coverage.
Note(s): These results include all episode types (Normal, PEP, Outlier, LUPA) and also include episodes from outlying areas (outside of 50 States and
District of Columbia). Only episodes with a through date in the year specified are included. Episodes with a claim frequency code equal to ``0''
(``Non-payment/zero claims'') and ``2'' (``Interim--first claim'') are excluded. If a beneficiary is treated by providers from multiple states within
a year the beneficiary is counted within each state's unique number of beneficiaries served.

[[Page 38374]]

[GRAPHIC] [TIFF OMITTED] TP07JY14.000

For CY 2011, in addition to the implementation of the Affordable
Care Act face-to-face encounter requirement, HHAs were also subject to
new therapy reassessment requirements, payments were reduced to account
for increases in nominal case-mix, and the Affordable Care Act mandated
that the HH PPS payment rates be reduced by 5 percent to pay up to, but
no more than 2.5 percent of total HH PPS payments as outlier payments.
The estimated net impact to HHAs for CY 2011 was a decrease in total HH
PPS payments of 4.78 percent. Therefore, any changes in utilization
between CY 2010 and CY 2011 cannot be solely attributable to the
implementation of the face-to-face encounter requirement. For CY 2012
we recalibrated the case-mix weights, including the removal of two
hypertension codes from scoring points in the HH PPS Grouper and
lowering the case-mix weights for high therapy cases estimated net
impact to HHAs, and reduced HH PPS rates in CY 2012 by 3.79 percent to
account for additional growth in aggregate case-mix that was unrelated
to changes in patients' health status. The estimated net impact to HHAs
for CY 2012 was a decrease in total HH PPS payments of 2.31 percent.
Again, any changes in utilization between CY 2011 and CY 2012 cannot be
solely attributable to the implementation of the face-to-face encounter
requirement. Given that a decrease in the number of episodes between CY
2010 and CY 2012 occurred in states that have the highest home health
utilization (number of episodes per Part A and/or Part B FFS
beneficiaries) and not all states experienced declines in episode
volume during that time period, we believe that the implementation of
the face-to-face encounter requirement could be considered a
contributing factor. We will continue to monitor for potential impacts
due to the implementation of the face-to-face encounter requirements
and other policy changes in the future. Independent effects of any one
policy may be difficult to discern in years where multiple policy
changes occur in any given year.

B. Proposed Changes to the Face-to-Face Encounter Requirements

1. Statutory and Regulatory Requirements
As a condition for payment, section 6407 of the Affordable Care Act
requires that, prior to certifying a patient's eligibility for the
Medicare home health benefit, the physician must document that the
physician himself or herself or an allowed nonphysician practitioner
(NPP) had a face-to-face encounter with the patient. Specifically,
sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act, as amended by the
Affordable Care Act, state that a nurse practitioner or clinical nurse
specialist, as those terms are defined in section 1861(aa)(5) of the
Act, working in collaboration with the physician in accordance with
state law, or a certified nurse-midwife (as defined in section 1861(gg)
of the Act) as authorized by state law, or a physician assistant (as
defined in section 1861(aa)(5) of the Act) under the supervision of the
physician may perform the face-to-face encounter.
The goal of the Affordable Care Act provision was to achieve
greater physician accountability in certifying a

[[Page 38375]]

patient's eligibility and in establishing a patient's plan of care. We
believed this goal could be better achieved if the face-to-face
encounter occurred closer to the start of home health care, increasing
the likelihood that the clinical conditions exhibited by the patient
during the encounter are related to the primary reason the patient
comes to need home health care. The certifying physician is responsible
for determining whether the patient meets the eligibility criteria
(that is, homebound and skilled need) and for understanding the current
clinical needs of the patient such that he or she can establish an
effective plan of care. As such, CMS regulations at Sec.
424.22(a)(1)(v) require that that the face-to-face encounter be related
to the primary reason the patient requires home health services and
occur no more than 90 days prior to the home health start of care date
or within 30 days of the start of the home health care. In addition, as
part of the certification of eligibility, the certifying physician must
document the date of the encounter and include an explanation
(narrative) of why the clinical findings of such encounter support that
the patient is homebound, as defined in sections 1835(a) and 1814(a) of
the Act, and in need of either intermittent skilled nursing services or
therapy services, as defined in Sec. 409.42(c).
The ``Requirements for Home Health Services'' describes certifying
a patient's eligibility for the Medicare home health benefit, and as
stated in the ``Content of the Certification'' under Sec. 424.22
(a)(1), a physician must certify that:
The individual needs or needed intermittent skilled
nursing care, physical therapy, and/or speech-language pathology
services as defined in Sec. 409.42(c).
Home health services are or were required because the
individual was confined to the home (as defined in sections 1835(a) and
1814(a) of the Act), except when receiving outpatient services.
A plan for furnishing the services has been established
and is or will be periodically reviewed by a physician who is a doctor
of medicine, osteopathy, or podiatric medicine (a doctor of podiatric
medicine may perform only plan of treatment functions that are
consistent with the functions he or she is authorized to perform under
state law).\1\
---------------------------------------------------------------------------

\1\ The physician cannot have a financial relationship as
defined in Sec. 411.354 of this chapter, with that HHA, unless the
physician's relationship meets one of the exceptions in section 1877
of the Act, which sets forth general exceptions to the referral
prohibition related to both ownership/investment and compensation;
exceptions to the referral prohibition related to ownership or
investment interests; and exceptions to the referral prohibition
related to compensation arrangements.
---------------------------------------------------------------------------

Home health services will be or were furnished while the
individual is or was under the care of a physician who is a doctor of
medicine, osteopathy, or podiatric medicine.
A face-to-face patient encounter occurred no more than 90
days prior to the home health start of care date or within 30 days of
the start of the home health care and was related to the primary reason
the patient requires home health services. This also includes
documenting the date of the encounter and including an explanation of
why the clinical findings of such encounter support that the patient is
homebound (as defined in Sec. 1835(a) and Sec. 1814(a) of the Act)
and in need of either intermittent skilled nursing services or therapy
services as defined in Sec. 409.42(c). The documentation must be
clearly titled and dated and the documentation must be signed by the
certifying physician.
For instances where the physician orders skilled nursing visits for
management and evaluation of the patient's care plan,\2\ the physician
must include a brief narrative that describes the clinical
justification of this need and the narrative must be located
immediately before the physician's signature. If the narrative exists
as an addendum to the certification form, in addition to the
physician's signature on the certification form, the physician must
sign immediately after the narrative in the addendum.
---------------------------------------------------------------------------

\2\ Skilled nursing visits for management and evaluation of the
patient's care plan are reasonable and necessary where underlying
conditions or complications require that only a registered nurse can
ensure that essential unskilled care is achieving its purpose. For
skilled nursing care to be reasonable and necessary for management
and evaluation of the patient's plan of care, the complexity of the
necessary unskilled services that are a necessary part of the
medical treatment must require the involvement of skilled nursing
personnel to promote the patient's recovery and medical safety in
view of the patient's overall condition (reference Sec. 409.33 and
section 40.1.2.2 in Chapter 7 of the Medicare Benefits Policy Manual
(Pub. 100-02)).
---------------------------------------------------------------------------

When there is a continuous need for home health care after an
initial 60-day episode of care, a physician is also required to
recertify the patient's eligibility for the home health benefit. In
accordance with Sec. 424.22 (b), a recertification is required at
least every 60 days, preferably at the time the plan is reviewed, and
must be signed and dated by the physician who reviews the plan of care.
In recertifying the patient's eligibility for the home health benefit,
the recertification must indicate the continuing need for skilled
services and estimate how much longer the skilled services will be
required. The need for occupational therapy may be the basis for
continuing services that were initiated because the individual needed
skilled nursing care or physical therapy or speech-language pathology
services. Again, for instances where the physician ordering skilled
nursing visits for management and evaluation of the patient's care
plan, the physician must include a brief narrative that describes the
clinical justification of this need and the narrative must be located
immediately before the physician's signature. If the narrative exists
as an addendum to the recertification form, in addition to the
physician's signature on the recertification form, the physician must
sign immediately after the narrative in the addendum.
In the CY 2012 HH PPS final rule (76 FR 68597), we stated that, in
addition to the certifying physician and allowed NPPs (as defined by
the Act and outlined above), the physician who cared for the patient in
an acute or post-acute care facility from which the patient was
directly admitted to home health care, and who had privileges in such
facility, could also perform the face-to-face encounter. In the CY 2013
HH PPS final rule (77 FR 67068) we revised our regulations so that an
allowed NPP, collaborating with or under the supervision of the
physician who cared for the patient in the acute/post-acute care
facility, can communicate the clinical findings that support the
patient's needs for skilled care and homebound status to the acute/
post-acute care physician. In turn, the acute/post-acute care physician
would communicate the clinical findings that support the patient's
needs for skilled care and homebound status from the encounter
performed by the NPP to the certifying physician to document. Policy
always permitted allowed NPPs in the acute/post-acute care setting from
which the patient is directly admitted to home health care to perform
the face-to-face encounter and communicate directly with the certifying
physician the clinical findings from the encounter and how such
findings support that the patient is homebound and needs skilled
services (77 FR 67106).
2. Proposed Changes to the Face-to-Face Encounter Narrative Requirement
and Non-Coverage of Associated Physician Certification/Re-Certification
Claims
Each year, the CMS' Office of Financial Management (OFM), under the
Comprehensive Error Rate Testing (CERT) program, calculates the
Medicare Fee-for-Service (FFS) improper payment rate. For the FY 2013

[[Page 38376]]

report period (reflecting claims processed between July 2011 and June
2012), the national Medicare FFS improper payment rate was calculated
to be 10.1 percent.\3\ For that same report period, the improper
payment rate for home health services was 17.3 percent, representing a
projected improper payment amount of approximately $3 billion.\4\ The
improper payments identified by the CERT program represent instances in
which a health care provider fails to comply with the Medicare coverage
and billing requirements and are not necessarily a result of fraudulent
activity.\5\
---------------------------------------------------------------------------

\3\ U.S. Department of Health and Human Services, ``FY 2013
Agency Financial Report'', accessed on April 23, 2014 at: http://www.hhs.gov/afr/2013-hhs-agency-financial-report.pdf.
\4\ U.S. Department of Health and Human Services, ``The
Supplementary Appendices for the Medicare Fee-for-Service 2013
Improper Payment Rate Report'', accessed on April 23, 2014 at:
http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/Downloads/November2013ReportPeriodAppendixFinal12-13-2013_508Compliance_Approved12-27-13.pdf.
\5\ The CERT improper payment rate is not a ``fraud rate,'' but
is a measurement of payments made that did not meet Medicare
requirements. The CERT program cannot label a claim fraudulent.
---------------------------------------------------------------------------

The majority of home health improper payments were due to
``insufficient documentation'' errors. ``Insufficient documentation''
errors occur when the medical documentation submitted is inadequate to
support payment for the services billed or when a specific
documentation element that is required (as described above) is missing.
Most ``insufficient documentation'' errors for home health occurred
when the narrative portion of the face-to-face encounter documentation
did not sufficiently describe how the clinical findings from the
encounter supported the beneficiary's homebound status and need for
skilled services, as required by Sec. 424.22(a)(1)(v).
The home health industry continues to voice concerns regarding the
implementation of the Affordable Care Act face-to-face encounter
documentation requirement. The home health industry cites challenges
that HHAs face in meeting the face-to-face encounter documentation
requirements regarding the required narrative, including a perceived
lack of established standards for compliance that can be adequately
understood and applied by the physicians and HHAs. In addition, the
home health industry conveys frustration with having to rely on the
physician to satisfy the face-to-face encounter documentation
requirements without incentives to encourage physician compliance.
Correspondence received to date has expressed concern over the
``extensive and redundant'' narrative required by regulation for face-
to-face encounter documentation purposes when detailed evidence to
support the physician certification of homebound status and medical
necessity is available in clinical records. In addition, correspondence
stated that the narrative requirement was not explicit in the
Affordable Care Act provision requiring a face-to-face encounter as
part of the certification of eligibility and that a narrative
requirement goes beyond Congressional intent.
We agree that there should be sufficient evidence in the patient's
medical record to demonstrate that the patient meets the Medicare home
health eligibility criteria. Therefore, in an effort to simplify the
face-to-face encounter regulations, reduce burden for HHAs and
physicians, and to mitigate instances where physicians and HHAs
unintentionally fail to comply with certification requirements, we
propose that:
(1) The narrative requirement in regulation at Sec.
424.22(a)(1)(v) would be eliminated. The certifying physician would
still be required to certify that a face-to-face patient encounter,
which is related to the primary reason the patient requires home health
services, occurred no more than 90 days prior to the home health start
of care date or within 30 days of the start of the home health care and
was performed by a physician or allowed non-physician practitioner as
defined in Sec. 424.22(a)(1)(v)(A), and to document the date of the
encounter as part of the certification of eligibility.
For instances where the physician is ordering skilled nursing
visits for management and evaluation of the patient's care plan, the
physician will still be required to include a brief narrative that
describes the clinical justification of this need as part of the
certification/re-certification of eligibility as outlined in Sec.
424.22(a)(1)(i) and Sec. 424.22(b)(2). This requirement was
implemented in the CY 2010 HH PPS final rule (74 FR 58111) and is not
changing.
(2) In determining whether the patient is or was eligible to
receive services under the Medicare home health benefit at the start of
care, we would review only the medical record for the patient from the
certifying physician or the acute/post-acute care facility (if the
patient in that setting was directly admitted to home health) used to
support the physician's certification of patient eligibility, as
described in paragraphs (a)(1) and (b) of this section. If the
patient's medical record, used by the physician in certifying
eligibility, was not sufficient to demonstrate that the patient was
eligible to receive services under the Medicare home health benefit,
payment would not be rendered for home health services provided.
(3) Physician claims for certification/re-certification of
eligibility for home health services (G0180 and G0179, respectively)
would not be covered if the HHA claim itself was non-covered because
the certification/re-certification of eligibility was not complete or
because there was insufficient documentation to support that the
patient was eligible for the Medicare home health benefit. However,
rather than specify this in our regulations, this proposal would be
implemented through future sub-regulatory guidance.
We believe that these proposals are responsive to home health
industry concerns regarding the face-to-face encounter requirements
articulated above. We invite comment on these proposals and the
associated change in the regulation at Sec. 424.22 in section VI.
3. Proposed Clarification on When Documentation of a Face-to-Face
Encounter Is Required
In the CY 2011 HH PPS final rule (75 FR 70372), in response to a
commenter who asked whether the face-to-face encounter is required only
for the first episode, we stated that the Congress enacted the face-to-
face encounter requirement to apply to the physician's certification,
not recertifications. In sub-regulatory guidance (face-to-face
encounter Q&As on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/Home-Health-Questions-Answers.pdf), response to Q&A 11 states that the
face-to-face encounter requirement applies to ``initial episodes'' (the
first in a series of episodes separated by no more than a 60-day gap).
The distinction between what is considered a certification (versus a
recertification) and what is considered an initial episode is important
in determining whether the face-to-face encounter requirement is
applicable.
Recent inquiries question whether the face-to-face encounter
requirement applies to situations where the beneficiary was discharged
from home health with goals met/no expectation of return to home health
care and readmitted to home health less than 60 days later. In this
situation, the second episode would be considered a certification, not
a recertification, because the HHA would be required to complete a new
start of care OASIS to initiate care. However, for payment

[[Page 38377]]

purposes, the second episode would be considered a subsequent episode,
because there was no gap of 60 days or more between the first and
second episodes of care. Therefore, in order to determine when
documentation of a patient's face-to-face encounter is required under
sections 1814(a)(2)(C) and 1835 (a)(2)(A) of the Act, we are proposing
to clarify that the face-to-face encounter requirement is applicable
for certifications (not recertifications), rather than initial
episodes. A certification (versus recertification) is considered to be
any time that a new start of care OASIS is completed to initiate care.
Because we are proposing to clarify that a certification is considered
to be any time a that a new start of care OASIS is completed to
initiate care, we would also revise Q&A 11 on the CMS Web site
(http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/Home-Health-Questions-Answers.pdf) to reflect
this proposed clarification. If a patient was transferred to the
hospital and remained in the hospital after day 61 (or after the first
day of the next certification period), once the patient returns home, a
new start of care OASIS must be completed. Therefore, this new episode
would not be considered continuous and a face-to-face encounter needs
to be documented as part of the certification of patient
eligibility.\6\
---------------------------------------------------------------------------

\6\ http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/OASIS/downloads/OASISConsiderationsforPPS.pdf.
---------------------------------------------------------------------------

C. Proposed Recalibration of the HH PPS Case-Mix Weights

For CY 2012, we removed two hypertension codes from our case-mix
system and recalibrated the case-mix weights in a budget neutral
manner. When recalibrating the case-mix weights for the CY 2012 HH PPS
final rule, we used CY 2005 data in the four-equation model used to
determine the clinical and functional points for a home health episode
and CY 2007 data in the payment regression model used to determine the
case-mix weights. We estimated the coefficients for the variables in
the four-equation model using CY 2005 data to maintain the same
variables we used for CY 2008 when we implemented the four-equation
model, thus minimizing substantial changes. Due to a noticeable shift
in the number of therapy visits provided as a result of the 2008
refinements, at the time, we decided to use CY 2007 data in the payment
regression. As part of the CY 2012 recalibration, we lowered the high
therapy weights and raised the low or no therapy weights to address
MedPAC's concerns that the HH PPS overvalues therapy episodes and
undervalues non-therapy episodes (March 2011 MedPAC Report to the
Congress: Medicare Payment Policy, p. 176). These adjustments better
aligned the case-mix weights with episode costs estimated from cost
report data. The CY 2012 recalibration, itself, was implemented in a
budget neutral manner. However, we note that in the CY 2012 HH PPS
final rule, we also finalized a 3.79 percent reduction to payments in
CY 2012 and a 1.32 percent reduction for CY 2013 to account for the
nominal case-mix growth identified through CY 2009.
For CY 2014, as part of the Affordable Care Act mandated rebasing
effort, we reset the case-mix weights, lowering the average case-mix
weight to 1.0000. To lower the case-mix weights to 1.0000, each case-
mix weight was decreased by the same factor (1.3464), thereby
maintaining the same relative values between the weights. This
resetting of the case-mix weights was done in a budget neutral manner,
inflating the starting point for rebasing by the same factor that was
used to decrease the weights. In the CY 2014 HH PPS final rule, we also
finalized a reduction ($80.95) to the national, standardized 60-day
episode payment amount each year from CY 2014 through CY 2017 to better
align payments with costs (78 FR 72293).
For CY 2015, we propose to recalibrate the case-mix weights,
adjusting the weights relative to one another using more current data
and aligning payments with current utilization data in a budget neutral
manner. We are also proposing to recalibrate the case-mix weights in
subsequent payment updates based on the methodology finalized in the CY
2012 HH PPS final rule (76 FR 68526) and the 2008 refinements (72 FR
25359-25392), with the proposed minor changes outlined below. We used
preliminary CY 2013 home health claims data (as of December 31, 2013)
to generate the proposed CY 2015 case-mix weights using the same
methodology finalized in the CY 2012 HH PPS final rule, except where
noted below. Similar to the CY 2012 recalibration, some exclusion
criteria were applied to the CY 2013 home health claims data used to
generate the proposed CY 2015 case-mix weights. Specifically, we
excluded Request for Anticipated Payment (RAP) claims, claims without a
matched OASIS, claims where total minutes equal 0, claims where the
payment amount equals 0, claims where paid days equal 0, claims where
covered visits equal 0, and claims without a HIPPS code. In addition,
the episodes used in the recalibration were normal episodes. PEP, LUPA,
outlier, and capped outlier (that is, episodes that are paid as normal
episodes, but would have been outliers had the HHA not reached the
outlier cap) episodes were dropped from the data file.\7\
---------------------------------------------------------------------------

\7\ At a later point, when normalizing the weights, PEP episodes
are included in the analysis.
---------------------------------------------------------------------------

Similar to the CY 2012 recalibration, the first step in the
proposed CY 2015 recalibration was to re-estimate the four-equation
model used to determine the clinical and functional points for an
episode. The dependent variable for the CY 2015 recalibration is the
same as the CY 2012 recalibration, wage-weighted minutes of care. The
wage-weighted minutes of care are determined using the CY 2012 Bureau
of Labor Statistics national hourly wage plus fringe rates for the six
home health disciplines and the minutes per visit from the claim.
The CY 2012 four-equation model contained the same variables and
restrictions as the four-equation model used in the CY 2008 refinements
(http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Reports/Downloads/Coleman_Final_April_2008.pdf).
The model was estimated using CY 2005 data, same data used in the CY
2008 refinements, thereby minimizing changes in the points for the CY
2012 four-equation model. For the CY 2015 four-equation model, we re-
examined all of the four-equation or ``leg'' variables for each of the
51 grouper variables in the CY 2008 model. Therefore, a grouper
variable that may have dropped out of the model in one of the four
equations in CY 2008 may be in the CY 2015 four-equation model and vice
versa. Furthermore, the specific therapy indicator variables that were
in the CY 2012 four-equation model were dropped in the CY 2015 four-
equation model so that the number of therapy visits provided had less
of an impact on the process used to create the case-mix weights.
The steps used to estimate the four-equation model are similar to
the steps used in the CY 2008 refinements. They are as follows: \8\
---------------------------------------------------------------------------

\8\ All the regressions mentioned in steps 1-4 are estimated
with robust standard errors clustered at the beneficiary ID level.
This is to account for beneficiaries appearing in the data multiple
times. When that occurs, the standard errors can be correlated
causing the p-value to be biased downward. Clustered standard errors
account for that bias.
---------------------------------------------------------------------------

(1) We estimated a regression model where the dependent variable is
wage-

[[Page 38378]]

weighted minutes of care. Independent variables were indicators for
which equation or ``leg'' the episode is in. The four legs of the model
are leg 1: Early episodes 0-13 therapy visits, leg 2: Early episodes
14+ therapy visits, leg 3: Later episodes 0-13 therapy visits, and leg
4: Later episodes 14+ therapy visits.\9\ Also, independent variables
for each of the 51 grouper variables for each leg of the model are
included in the model.
---------------------------------------------------------------------------

\9\ Early episodes are defined as the 1st or 2nd episode in a
sequence of adjacent covered episodes. Later episodes are defined as
the 3rd episode and beyond in a sequence of adjacent covered
episodes. Episodes are considered to be adjacent if they are
separated by no more than a 60-day period between claims.
---------------------------------------------------------------------------

(2) Once the four-equation model is estimated, we drop all grouper
variables with a coefficient less than 5 from the model. We re-estimate
the model and continue to drop variables and re-estimate until there
are no grouper variables with a coefficient of 5 or less.
(3) Taking the final iteration of the model in the previous step,
we drop all grouper variables with a p-value greater than 0.10. We then
re-estimate the model.
(4) Taking the model in the previous step, we begin to apply
restrictions to certain coefficients. Within a grouper variable we
first look across the coefficients for leg1 and leg3. We perform an
equality test on those coefficients. If the coefficients are not
significantly different from one another (using a p-value of 0.05), we
set a restriction for that grouper variable such that the coefficients
are equal across leg1 and leg3. We run these tests for all grouper
variables for leg1 and leg3. We also run these tests for all grouper
variables for leg2 and leg4.\10\ After all restrictions are set, we re-
run the regression again taking those restrictions into account.
---------------------------------------------------------------------------

\10\ In the CY 2008 rule, there was a further step taken to
determine if the coefficients of a grouper variable are equal across
all 4 legs. This step was not taken at this time.
---------------------------------------------------------------------------

(5) Taking in the model from step 4, we drop variables that have a
coefficient less than 5 and re-estimate the model a final time. Using
preliminary 2013 claims data, there was only 1 grouper variable with a
negative coefficient that was dropped from the model.
The results from the final four-equation model are used to
determine the clinical and functional points for an episode and place
episodes in the different clinical and functional levels used to
estimate the payment regression model. We take the coefficients from
the four equation model, divide them by 10, and round to the nearest
integer to determine the points associated with each variable. The
points for each of the grouper variables for each leg of the model are
shown in Table 8. The points for the clinical variables are added
together to determine an episode's clinical score. The points for the
functional variables are added together to determine an episode's
functional score.

Table 8--Case-Mix Adjustment Variables and Scores
--------------------------------------------------------------------------------------------------------------------------------------------------------

---------------------------------------------------------------------------------------------------------------------------------------------
Episode number within sequence of adjacent 1 or 2............................. 1 or 2 3+ 3+
episodes.
Therapy visits.............................. 0-13............................... 14+ 0-13 14+
EQUATION:................................... 1.................................. 2 3 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
CLINICAL DIMENSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Primary or Other Diagnosis = Blindness/Low ................................... ........... ........... ...........
Vision.
2 Primary or Other Diagnosis = Blood disorders ................................... 6 ........... 3
3 Primary or Other Diagnosis = Cancer, ................................... 8 ........... 8
selected benign neoplasms.
4 Primary Diagnosis = Diabetes................ ................................... 8 ........... 8
5 Other Diagnosis = Diabetes.................. 1.................................. ........... ........... ...........
6 Primary or Other Diagnosis = Dysphagia...... 2.................................. 16 1 9
AND.........................................
Primary or Other Diagnosis = Neuro 3--Stroke
7 Primary or Other Diagnosis = Dysphagia...... 2.................................. 7 ........... 7
AND.........................................
M1030 (Therapy at home) = 3 (Enteral).......
8 Primary or Other Diagnosis = ................................... ........... ........... ...........
Gastrointestinal disorders.
9 Primary or Other Diagnosis = ................................... 5 ........... ...........
Gastrointestinal disorders.
AND.........................................
M1630 (ostomy) = 1 or 2.....................
10 Primary or Other Diagnosis = ................................... ........... ........... ...........
Gastrointestinal disorders.
AND.........................................
Primary or Other Diagnosis = Neuro 1--Brain
disorders and paralysis, OR Neuro 2--
Peripheral neurological disorders, OR Neuro
3--Stroke, OR Neuro 4--Multiple Sclerosis.
11 Primary or Other Diagnosis = Heart Disease 1.................................. ........... ........... ...........
OR Hypertension.
12 Primary Diagnosis = Neuro 1--Brain disorders 3.................................. 11 6 11
and paralysis.
13 Primary or Other Diagnosis = Neuro 1--Brain ................................... ........... ........... ...........
disorders and paralysis.
AND.........................................
M1840 (Toilet transfer) = 2 or more.........
14 Primary or Other Diagnosis = Neuro 1--Brain 2.................................. 7 1 7
disorders and paralysis OR Neuro 2--
Peripheral neurological disorders.
AND.........................................
M1810 or M1820 (Dressing upper or lower
body) = 1, 2, or 3.
15 Primary or Other Diagnosis = Neuro 3--Stroke 3.................................. 10 2 ...........
16 Primary or Other Diagnosis = Neuro 3--Stroke ................................... 4 ........... 9
AND.
M1810 or M1820 (Dressing upper or lower
body) = 1, 2, or 3.
17 Primary or Other Diagnosis = Neuro 3--Stroke ................................... ........... ........... ...........
AND.........................................
M1860 (Ambulation) = 4 or more..............

[[Page 38379]]

18 Primary or Other Diagnosis = Neuro 4-- 3.................................. 8 6 14
Multiple Sclerosis AND AT LEAST ONE OF THE
FOLLOWING:.
M1830 (Bathing) = 2 or more.................
OR..........................................
M1840 (Toilet transfer) = 2 or more.........
OR..........................................
M1850 (Transferring) = 2 or more............
OR..........................................
M1860 (Ambulation) = 4 or more..............
19 Primary or Other Diagnosis = Ortho 1--Leg 8.................................. 1 8 4
Disorders or Gait Disorders.
AND.........................................
M1324 (most problematic pressure ulcer
stage) = 1, 2, 3 or 4.
20 Primary or Other Diagnosis = Ortho 1--Leg OR 3.................................. 4 3 ...........
Ortho 2--Other orthopedic disorders.
AND.........................................
M1030 (Therapy at home) = 1 (IV/Infusion) or
2 (Parenteral).
21 Primary or Other Diagnosis = Psych 1-- ................................... ........... ........... ...........
Affective and other psychoses, depression.
22 Primary or Other Diagnosis = Psych 2-- ................................... ........... ........... ...........
Degenerative and other organic psychiatric
disorders.
23 Primary or Other Diagnosis = Pulmonary ................................... ........... ........... ...........
disorders.
24 Primary or Other Diagnosis = Pulmonary ................................... ........... ........... ...........
disorders AND.
M1860 (Ambulation) = 1 or more..............
25 Primary Diagnosis = Skin 1--Traumatic 4.................................. 20 8 20
wounds, burns, and post-operative
complications.
26 Other Diagnosis = Skin 1--Traumatic wounds, 5.................................. 14 7 14
burns, post-operative complications.
27 Primary or Other Diagnosis = Skin 1-- 4.................................. ........... 1 ...........
Traumatic wounds, burns, and post-operative
complications OR Skin 2--Ulcers and other
skin conditions.
AND.........................................
M1030 (Therapy at home) = 1 (IV/Infusion) or
2 (Parenteral).
28 Primary or Other Diagnosis = Skin 2--Ulcers 2.................................. 17 8 17
and other skin conditions.
29 Primary or Other Diagnosis = Tracheostomy... 4.................................. 16 4 16
30 Primary or Other Diagnosis = Urostomy/ ................................... 18 ........... 14
Cystostomy.
31 M1030 (Therapy at home) = 1 (IV/Infusion) or ................................... 17 5 17
2 (Parenteral).
32 M1030 (Therapy at home) = 3 (Enteral)....... ................................... 16 ........... 7
33 M1200 (Vision) = 1 or more.................. ................................... ........... ........... ...........
34 M1242 (Pain) = 3 or 4....................... 2.................................. ........... 1 ...........
35 M1308 = Two or more pressure ulcers at stage 4.................................. 7 4 7
3 or 4.
36 M1324 (Most problematic pressure ulcer 3.................................. 18 7 15
stage) = 1 or 2.
37 M1324 (Most problematic pressure ulcer 8.................................. 31 11 26
stage) = 3 or 4.
38 M1334 (Stasis ulcer status) = 2............. 4.................................. 12 7 22
39 M1334 (Stasis ulcer status) = 3............. 7.................................. 17 10 17
40 M1342 (Surgical wound status) = 2........... 1.................................. 7 6 14
41 M1342 (Surgical wound status) = 3........... ................................... 6 5 10
42 M1400 (Dyspnea) = 2, 3, or 4................ ................................... 2 ........... 3
43 M1620 (Bowel Incontinence) = 2 to 5......... ................................... 3 ........... 3
44 M1630 (Ostomy) = 1 or 2..................... 4.................................. 11 3 11
45 M2030 (Injectable Drug Use) = 0, 1, 2, or 3. ................................... ........... ........... ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
FUNCTIONAL DIMENSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
46 M1810 or M1820 (Dressing upper or lower 2.................................. ........... 1 ...........
body) = 1, 2, or 3.
47 M1830 (Bathing) = 2 or more................. 6.................................. 3 5 ...........
48 M1840 (Toilet transferring) = 2 or more..... 1.................................. 3 ........... 3
49 M1850 (Transferring) = 2 or more............ 3.................................. 4 2 ...........
50 M1860 (Ambulation) = 1, 2 or 3.............. 7.................................. ........... 3 ...........
51 M1860 (Ambulation) = 4 or more.............. 7.................................. 8 6 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: CY 2013 home health claims data as of December 31, 2013 from the home health Standard Analytic File (SAF). We excluded LUPA episodes, outlier
episodes, and episodes with PEP adjustments.
Note(s): Points are additive, however points may not be given for the same line item in the table more than once. Please see Medicare Home Health
Diagnosis Coding guidance at: http://www.cms.hhs.gov/HomeHealthPPS/03_coding&billing.asp for definitions of primary and secondary diagnoses.

In updating the four-equation model with 2013 data (the last update
to the four-equation model used 2005 data), there were significant
changes to the point values for the variables in the four-equation
model. These reflect changes in the relationship between the grouper
variables and resource use since 2005. The CY 2015 four-equation model
resulted in 121 point-giving variables being used in the model (as
compared to the 164 variables for the 2012 recalibration). There were
19 variables that were added to the model and 62 variables that were
dropped from the

[[Page 38380]]

model due to the lack of additional resources associated with the
variable. The points for 56 variables increased in the CY 2015 four-
equation model and the points for 28 variables in decreased in the CY
2015 four-equation model.
Since there were a number of significant changes to the point
values associated with the four-equation model, we are proposing to
redefine the clinical and functional thresholds so that they would be
reflective of the new points associated with the CY 2015 four-equation
model. Specifically, after estimating the points for each of the
variables and summing the clinical and functional points for each
episode, we looked at the distribution of the clinical score and
functional score, breaking the episodes into different steps. The
categorizations for the steps are as follows:
Step 1: First and second episodes, 0-13 therapy visits.
Step 2.1: First and second episodes, 14-19 therapy visits.
Step 2.2: Third episodes and beyond, 14-19 therapy visits.
Step 3: Third episodes and beyond, 0-13 therapy visits.
Step 4: Episodes with 20+ therapy visits.
Similar to the methodology used in the CY 2008 refinements, we then
divide the distribution of the clinical score for episodes within a
step such that a third of episodes are classified as low clinical
score, a third of episodes are classified as medium clinical score, and
a third of episodes are classified as high clinical score. The same
approach is then done looking at the functional score. It was not
always possible to evenly divide the episodes within each level, by
step, into thirds due to many episodes being clustered around one
particular score.\11\ Also, we looked at the average resource use
associated with each clinical and functional score and used that to
guide where we placed our thresholds. We tried to group scores with
similar average resource use within the same level (even if it means
that more or less than a third of episodes are placed within a level by
step). The new thresholds based off of the CY 2015 four-equation model
points are shown in Table 9.
---------------------------------------------------------------------------

\11\ For Step 1, 55% of episodes were in the medium functional
level (All with score 15).
For Step 2.1, 60.9% of episodes were in the low functional level
(Most with score 3, some with score 0).
For Step 2.2, 70.3% of episodes were in the low functional level
(All with score 0).
For Step 3, 52.3% of episodes were in the medium functional
level (all with score 9).
For Step 4, 41.6% of episodes were in the medium functional
level (almost all with score 3).

Table 9--CY 2015 Clinical and Functional Thresholds
--------------------------------------------------------------------------------------------------------------------------------------------------------
1st and 2nd episodes 3rd+ episodes All episodes
----------------------------------------------------------------------------------------------------
0 to 13 therapy 14 to 19 therapy 0 to 13 therapy 14 to 19 therapy
visits visits visits visits 20+ therapy visits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grouping Step: 1.................. 2................. 3................. 4................. 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Equation(s) used to calculate points: (see Table 8) 1.................. 2................. 3................. 4................. (2&4)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dimension...................... Severity Level....
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical....................... C1................ 0 to 1............. 0................. 0................. 0 to 3............ 0 to 3.
C2................ 2 to 3............. 1 to 7............ 1................. 4 to 12........... 4 to 16.
C3................ 4+................. 8+................ 2+................ 13+............... 17+.
Functional..................... F1................ 0 to 14............ 0 to 3............ 0 to 8............ 0................. 0 to 2.
F2................ 15................. 4 to 12........... 9................. 1 to 7............ 3 to 4.
F3................ 16+................ 13+............... 10+............... 8+................ 5+.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Once the thresholds were determined and each episode was assigned a
clinical and functional level, the payment regression was estimated
with an episode's wage-weighted minutes of care as the dependent
variable. Independent variables in the model were indicators for the
step of the episode as well for the clinical and functional levels
within each step of the episode. Like the four-equation model, the
payment regression model is also estimated with robust standard errors
that are clustered at the beneficiary level. Table 10 shows the
regression coefficients for the variables in the proposed payment
regression model. The R-squared value for the payment regression model
is 0.4691 (an increase from 0.3769 for the CY 2012 recalibration).

Table 10--Proposed Payment Regression Model
------------------------------------------------------------------------
Proposed CY 2015
payment
Variable description regression
coefficients
------------------------------------------------------------------------
Step 1, Clinical Score Medium........................ $24.43
Step 1, Clinical Score High.......................... 59.46
Step 1, Functional Score Medium...................... 81.03
Step 1, Functional Score High........................ 120.87
Step 2.1, Clinical Score Medium...................... 56.61
Step 2.1, Clinical Score High........................ 175.83
Step 2.1, Functional Score Medium.................... 25.84
Step 2.1, Functional Score High...................... 90.77
Step 2.2, Clinical Score Medium...................... 90.83
Step 2.2, Clinical Score High........................ 201.06
Step 2.2, Functional Score Medium.................... 18.50

[[Page 38381]]

Step 2.2, Functional Score High...................... 91.18
Step 3, Clinical Score Medium........................ 10.42
Step 3, Clinical Score High.......................... 85.74
Step 3, Functional Score Medium...................... 49.62
Step 3, Functional Score High........................ 84.57
Step 4, Clinical Score Medium........................ 77.85
Step 4, Clinical Score High.......................... 237.87
Step 4, Functional Score Medium...................... 38.26
Step 4, Functional Score High........................ 93.84
Step 2.1, 1st and 2nd Episodes, 14 to 19 Therapy 438.76
Visits..............................................
Step 2.2, 3rd+ Episodes, 14 to 19 Therapy Visits..... 448.05
Step 3, 3rd+ Episodes, 0-13 Therapy Visits........... -65.84
Step 4, All Episodes, 20+ Therapy Visits............. 857.63
Intercept............................................ 368.93
------------------------------------------------------------------------
Source: CY 2013 home health claims data as of December 31, 2013 from the
home health standard analytic file (SAF).

The method used to derive the proposed CY 2015 case-mix weights
from the payment regression model coefficients is the same as the
method used to derive the CY 2012 case-mix weights. This method is
described below.
(1) We used the coefficients from the payment regression model to
predict each episode's wage-weighted minutes of care (resource use). We
then divided these predicted values by the mean of the dependent
variable (that is, the average wage-weighted minutes of care across all
episodes used in the payment regression). This division constructs the
weight for each episode, which is simply the ratio of the episode's
predicted wage-weighted minutes of care divided by the average wage-
weighted minutes of care in the sample. Each episode was then
aggregated into one of the 153 home health resource groups (HHRGs) and
the ``raw'' weight for each HHRG was calculated as the average of the
episode weights within the HHRG.
(2) In the next step of weight revision, the weights associated
with 0 to 5 therapy visits were increased by 3.75 percent. Also, the
weights associated with 14-15 therapy visits were decreased by 2.5
percent and the weights associated with 20+ therapy visits were
decreased by 5 percent. These adjustments were made to discourage
inappropriate use of therapy while addressing concerns that non-therapy
services are undervalued. These adjustments to the case-mix weights are
the same as the ones used in the CY 2012 recalibration (76 FR 68557).
(3) After the adjustments in step (2) were applied to the raw
weights, the weights were further adjusted to create an increase in the
payment weights for the therapy visit steps between the therapy
thresholds. Weights with the same clinical severity level, functional
severity level, and early/later episode status were grouped together.
Then within those groups, the weights for each therapy step between
thresholds were gradually increased. We did this by interpolating
between the main thresholds on the model (from 0-5 to 14-15 therapy
visits, and from 14-15 to 20+ therapy visits). We used a linear model
to implement the interpolation so the payment weight increase for each
step between the thresholds (such as the increase between 0-5 therapy
visits and 6 therapy visits and the increase between 6 therapy visits
and 7-9 therapy visits) was constant. This interpolation is the
identical to the process finalized in the CY 2012 final rule (76 FR
68555).
(4) The interpolated weights were then adjusted so that the average
case-mix for the weights was equal to 1.\12\ This last step creates the
proposed CY 2015 case-mix weights shown in Table 11.
---------------------------------------------------------------------------

\12\ When computing the average, we compute a weighted average,
assigning a value of one to each normal episode and a value equal to
the episode length divided by 60 for PEPs.

Table 11--Proposed CY 2015 Case-Mix Payment Weights
----------------------------------------------------------------------------------------------------------------
Clinical and functional
Payment group Step (episode and/or levels (1 = Low; 2 = CY 2015 proposed
therapy visit ranges) Medium; 3= High) case-mix weights
----------------------------------------------------------------------------------------------------------------
10111.............................. 1st and 2nd Episodes, 0 to C1F1S1 0.5984
5 Therapy Visits.
10112.............................. 1st and 2nd Episodes, 6 C1F1S2 0.7250
Therapy Visits.
10113.............................. 1st and 2nd Episodes, 7 to C1F1S3 0.8515
9 Therapy Visits.
10114.............................. 1st and 2nd Episodes, 10 C1F1S4 0.9781
Therapy Visits.
10115.............................. 1st and 2nd Episodes, 11 to C1F1S5 1.1046
13 Therapy Visits.
10121.............................. 1st and 2nd Episodes, 0 to C1F2S1 0.7299
5 Therapy Visits.
10122.............................. 1st and 2nd Episodes, 6 C1F2S2 0.8380
Therapy Visits.
10123.............................. 1st and 2nd Episodes, 7 to C1F2S3 0.9461
9 Therapy Visits.
10124.............................. 1st and 2nd Episodes, 10 C1F2S4 1.0543
Therapy Visits.
10125.............................. 1st and 2nd Episodes, 11 to C1F2S5 1.1624
13 Therapy Visits.
10131.............................. 1st and 2nd Episodes, 0 to C1F3S1 0.7945
5 Therapy Visits.
10132.............................. 1st and 2nd Episodes, 6 C1F3S2 0.9095
Therapy Visits.

[[Page 38382]]

10133.............................. 1st and 2nd Episodes, 7 to C1F3S3 1.0245
9 Therapy Visits.
10134.............................. 1st and 2nd Episodes, 10 C1F3S4 1.1395
Therapy Visits.
10135.............................. 1st and 2nd Episodes, 11 to C1F3S5 1.2545
13 Therapy Visits.
10211.............................. 1st and 2nd Episodes, 0 to C2F1S1 0.6381
5 Therapy Visits.
10212.............................. 1st and 2nd Episodes, 6 C2F1S2 0.7739
Therapy Visits.
10213.............................. 1st and 2nd Episodes, 7 to C2F1S3 0.9098
9 Therapy Visits.
10214.............................. 1st and 2nd Episodes, 10 C2F1S4 1.0457
Therapy Visits.
10215.............................. 1st and 2nd Episodes, 11 to C2F1S5 1.1816
13 Therapy Visits.
10221.............................. 1st and 2nd Episodes, 0 to C2F2S1 0.7695
5 Therapy Visits.
10222.............................. 1st and 2nd Episodes, 6 C2F2S2 0.8870
Therapy Visits.
10223.............................. 1st and 2nd Episodes, 7 to C2F2S3 1.0044
9 Therapy Visits.
10224.............................. 1st and 2nd Episodes, 10 C2F2S4 1.1219
Therapy Visits.
10225.............................. 1st and 2nd Episodes, 11 to C2F2S5 1.2394
13 Therapy Visits.
10231.............................. 1st and 2nd Episodes, 0 to C2F3S1 0.8341
5 Therapy Visits.
10232.............................. 1st and 2nd Episodes, 6 C2F3S2 0.9585
Therapy Visits.
10233.............................. 1st and 2nd Episodes, 7 to C2F3S3 1.0828
9 Therapy Visits.
10234.............................. 1st and 2nd Episodes, 10 C2F3S4 1.2071
Therapy Visits.
10235.............................. 1st and 2nd Episodes, 11 to C2F3S5 1.3315
13 Therapy Visits.
10311.............................. 1st and 2nd Episodes, 0 to C3F1S1 0.6949
5 Therapy Visits.
10312.............................. 1st and 2nd Episodes, 6 C3F1S2 0.8557
Therapy Visits.
10313.............................. 1st and 2nd Episodes, 7 to C3F1S3 1.0166
9 Therapy Visits.
10314.............................. 1st and 2nd Episodes, 10 C3F1S4 1.1775
Therapy Visits.
10315.............................. 1st and 2nd Episodes, 11 to C3F1S5 1.3383
13 Therapy Visits.
10321.............................. 1st and 2nd Episodes, 0 to C3F2S1 0.8263
5 Therapy Visits.
10322.............................. 1st and 2nd Episodes, 6 C3F2S2 0.9688
Therapy Visits.
10323.............................. 1st and 2nd Episodes, 7 to C3F2S3 1.1112
9 Therapy Visits.
10324.............................. 1st and 2nd Episodes, 10 C3F2S4 1.2537
Therapy Visits.
10325.............................. 1st and 2nd Episodes, 11 to C3F2S5 1.3961
13 Therapy Visits.
10331.............................. 1st and 2nd Episodes, 0 to C3F3S1 0.8909
5 Therapy Visits.
10332.............................. 1st and 2nd Episodes, 6 C3F3S2 1.0403
Therapy Visits.
10333.............................. 1st and 2nd Episodes, 7 to C3F3S3 1.1896
9 Therapy Visits.
10334.............................. 1st and 2nd Episodes, 10 C3F3S4 1.3389
Therapy Visits.
10335.............................. 1st and 2nd Episodes, 11 to C3F3S5 1.4882
13 Therapy Visits.
21111.............................. 1st and 2nd Episodes, 14 to C1F1S1 1.2312
15 Therapy Visits.
21112.............................. 1st and 2nd Episodes, 16 to C1F1S2 1.4280
17 Therapy Visits.
21113.............................. 1st and 2nd Episodes, 18 to C1F1S3 1.6249
19 Therapy Visits.
21121.............................. 1st and 2nd Episodes, 14 to C1F2S1 1.2706
15 Therapy Visits.
21122.............................. 1st and 2nd Episodes, 16 to C1F2S2 1.4732
17 Therapy Visits.
21123.............................. 1st and 2nd Episodes, 18 to C1F2S3 1.6759
19 Therapy Visits.
21131.............................. 1st and 2nd Episodes, 14 to C1F3S1 1.3695
15 Therapy Visits.
21132.............................. 1st and 2nd Episodes, 16 to C1F3S2 1.5667
17 Therapy Visits.
21133.............................. 1st and 2nd Episodes, 18 to C1F3S3 1.7639
19 Therapy Visits.
21211.............................. 1st and 2nd Episodes, 14 to C2F1S1 1.3175
15 Therapy Visits.
21212.............................. 1st and 2nd Episodes, 16 to C2F1S2 1.5241
17 Therapy Visits.
21213.............................. 1st and 2nd Episodes, 18 to C2F1S3 1.7307
19 Therapy Visits.
21221.............................. 1st and 2nd Episodes, 14 to C2F2S1 1.3569
15 Therapy Visits.
21222.............................. 1st and 2nd Episodes, 16 to C2F2S2 1.5693
17 Therapy Visits.
21223.............................. 1st and 2nd Episodes, 18 to C2F2S3 1.7817
19 Therapy Visits.
21231.............................. 1st and 2nd Episodes, 14 to C2F3S1 1.4558
15 Therapy Visits.
21232.............................. 1st and 2nd Episodes, 16 to C2F3S2 1.6628
17 Therapy Visits.
21233.............................. 1st and 2nd Episodes, 18 to C2F3S3 1.8698
19 Therapy Visits.
21311.............................. 1st and 2nd Episodes, 14 to C3F1S1 1.4992
15 Therapy Visits.
21312.............................. 1st and 2nd Episodes, 16 to C3F1S2 1.7245
17 Therapy Visits.
21313.............................. 1st and 2nd Episodes, 18 to C3F1S3 1.9498
19 Therapy Visits.
21321.............................. 1st and 2nd Episodes, 14 to C3F2S1 1.5386
15 Therapy Visits.
21322.............................. 1st and 2nd Episodes, 16 to C3F2S2 1.7697
17 Therapy Visits.
21323.............................. 1st and 2nd Episodes, 18 to C3F2S3 2.0008
19 Therapy Visits.
21331.............................. 1st and 2nd Episodes, 14 to C3F3S1 1.6376
15 Therapy Visits.
21332.............................. 1st and 2nd Episodes, 16 to C3F3S2 1.8632
17 Therapy Visits.
21333.............................. 1st and 2nd Episodes, 18 to C3F3S3 2.0888
19 Therapy Visits.
22111.............................. 3rd+ Episodes, 14 to 15 C1F1S1 1.2454
Therapy Visits.
22112.............................. 3rd+ Episodes, 16 to 17 C1F1S2 1.4375
Therapy Visits.
22113.............................. 3rd+ Episodes, 18 to 19 C1F1S3 1.6296
Therapy Visits.
22121.............................. 3rd+ Episodes, 14 to 15 C1F2S1 1.2736
Therapy Visits.
22122.............................. 3rd+ Episodes, 16 to 17 C1F2S2 1.4752
Therapy Visits.
22123.............................. 3rd+ Episodes, 18 to 19 C1F2S3 1.6769
Therapy Visits.
22131.............................. 3rd+ Episodes, 14 to 15 C1F3S1 1.3843
Therapy Visits.
22132.............................. 3rd+ Episodes, 16 to 17 C1F3S2 1.5766
Therapy Visits.

[[Page 38383]]

22133.............................. 3rd+ Episodes, 18 to 19 C1F3S3 1.7689
Therapy Visits.
22211.............................. 3rd+ Episodes, 14 to 15 C2F1S1 1.3838
Therapy Visits.
22212.............................. 3rd+ Episodes, 16 to 17 C2F1S2 1.5683
Therapy Visits.
22213.............................. 3rd+ Episodes, 18 to 19 C2F1S3 1.7529
Therapy Visits.
22221.............................. 3rd+ Episodes, 14 to 15 C2F2S1 1.4120
Therapy Visits.
22222.............................. 3rd+ Episodes, 16 to 17 C2F2S2 1.6061
Therapy Visits.
22223.............................. 3rd+ Episodes, 18 to 19 C2F2S3 1.8001
Therapy Visits.
22231.............................. 3rd+ Episodes, 14 to 15 C2F3S1 1.5228
Therapy Visits.
22232.............................. 3rd+ Episodes, 16 to 17 C2F3S2 1.7074
Therapy Visits.
22233.............................. 3rd+ Episodes, 18 to 19 C2F3S3 1.8921
Therapy Visits.
22311.............................. 3rd+ Episodes, 14 to 15 C3F1S1 1.5518
Therapy Visits.
22312.............................. 3rd+ Episodes, 16 to 17 C3F1S2 1.7596
Therapy Visits.
22313.............................. 3rd+ Episodes, 18 to 19 C3F1S3 1.9673
Therapy Visits.
22321.............................. 3rd+ Episodes, 14 to 15 C3F2S1 1.5800
Therapy Visits.
22322.............................. 3rd+ Episodes, 16 to 17 C3F2S2 1.7973
Therapy Visits.
22323.............................. 3rd+ Episodes, 18 to 19 C3F2S3 2.0146
Therapy Visits.
22331.............................. 3rd+ Episodes, 14 to 15 C3F3S1 1.6908
Therapy Visits.
22332.............................. 3rd+ Episodes, 16 to 17 C3F3S2 1.8987
Therapy Visits.
22333.............................. 3rd+ Episodes, 18 to 19 C3F3S3 2.1065
Therapy Visits.
30111.............................. 3rd+ Episodes, 0 to 5 C1F1S1 0.4916
Therapy Visits.
30112.............................. 3rd+ Episodes, 6 Therapy C1F1S2 0.6424
Visits.
30113.............................. 3rd+ Episodes, 7 to 9 C1F1S3 0.7931
Therapy Visits.
30114.............................. 3rd+ Episodes, 10 Therapy C1F1S4 0.9439
Visits.
30115.............................. 3rd+ Episodes, 11 to 13 C1F1S5 1.0946
Therapy Visits.
30121.............................. 3rd+ Episodes, 0 to 5 C1F2S1 0.5721
Therapy Visits.
30122.............................. 3rd+ Episodes, 6 Therapy C1F2S2 0.7124
Visits.
30123.............................. 3rd+ Episodes, 7 to 9 C1F2S3 0.8527
Therapy Visits.
30124.............................. 3rd+ Episodes, 10 Therapy C1F2S4 0.9930
Visits.
30125.............................. 3rd+ Episodes, 11 to 13 C1F2S5 1.1333
Therapy Visits.
30131.............................. 3rd+ Episodes, 0 to 5 C1F3S1 0.6288
Therapy Visits.
30132.............................. 3rd+ Episodes, 6 Therapy C1F3S2 0.7799
Visits.
30133.............................. 3rd+ Episodes, 7 to 9 C1F3S3 0.9310
Therapy Visits.
30134.............................. 3rd+ Episodes, 10 Therapy C1F3S4 1.0821
Visits.
30135.............................. 3rd+ Episodes, 11 to 13 C1F3S5 1.2332
Therapy Visits.
30211.............................. 3rd+ Episodes, 0 to 5 C2F1S1 0.5085
Therapy Visits.
30212.............................. 3rd+ Episodes, 6 Therapy C2F1S2 0.6836
Visits.
30213.............................. 3rd+ Episodes, 7 to 9 C2F1S3 0.8586
Therapy Visits.
30214.............................. 3rd+ Episodes, 10 Therapy C2F1S4 1.0337
Visits.
30215.............................. 3rd+ Episodes, 11 to 13 C2F1S5 1.2088
Therapy Visits.
30221.............................. 3rd+ Episodes, 0 to 5 C2F2S1 0.5890
Therapy Visits.
30222.............................. 3rd+ Episodes, 6 Therapy C2F2S2 0.7536
Visits.
30223.............................. 3rd+ Episodes, 7 to 9 C2F2S3 0.9182
Therapy Visits.
30224.............................. 3rd+ Episodes, 10 Therapy C2F2S4 1.0828
Visits.
30225.............................. 3rd+ Episodes, 11 to 13 C2F2S5 1.2474
Therapy Visits.
30231.............................. 3rd+ Episodes, 0 to 5 C2F3S1 0.6457
Therapy Visits.
30232.............................. 3rd+ Episodes, 6 Therapy C2F3S2 0.8211
Visits.
30233.............................. 3rd+ Episodes, 7 to 9 C2F3S3 0.9965
Therapy Visits.
30234.............................. 3rd+ Episodes, 10 Therapy C2F3S4 1.1720
Visits.
30235.............................. 3rd+ Episodes, 11 to 13 C2F3S5 1.3474
Therapy Visits.
30311.............................. 3rd+ Episodes, 0 to 5 C3F1S1 0.6307
Therapy Visits.
30312.............................. 3rd+ Episodes, 6 Therapy C3F1S2 0.8149
Visits.
30313.............................. 3rd+ Episodes, 7 to 9 C3F1S3 0.9992
Therapy Visits.
30314.............................. 3rd+ Episodes, 10 Therapy C3F1S4 1.1834
Visits.
30315.............................. 3rd+ Episodes, 11 to 13 C3F1S5 1.3676
Therapy Visits.
30321.............................. 3rd+ Episodes, 0 to 5 C3F2S1 0.7112
Therapy Visits.
30322.............................. 3rd+ Episodes, 6 Therapy C3F2S2 0.8850
Visits.
30323.............................. 3rd+ Episodes, 7 to 9 C3F2S3 1.0587
Therapy Visits.
30324.............................. 3rd+ Episodes, 10 Therapy C3F2S4 1.2325
Visits.
30325.............................. 3rd+ Episodes, 11 to 13 C3F2S5 1.4063
Therapy Visits.
30331.............................. 3rd+ Episodes, 0 to 5 C3F3S1 0.7679
Therapy Visits.
30332.............................. 3rd+ Episodes, 6 Therapy C3F3S2 0.9525
Visits.
30333.............................. 3rd+ Episodes, 7 to 9 C3F3S3 1.1370
Therapy Visits.
30334.............................. 3rd+ Episodes, 10 Therapy C3F3S4 1.3216
Visits.
30335.............................. 3rd+ Episodes, 11 to 13 C3F3S5 1.5062
Therapy Visits.
40111.............................. All Episodes, 20+ Therapy C1F1S1 1.8217
Visits.
40121.............................. All Episodes, 20+ Therapy C1F2S1 1.8786
Visits.
40131.............................. All Episodes, 20+ Therapy C1F3S1 1.9611
Visits.
40211.............................. All Episodes, 20+ Therapy C2F1S1 1.9374
Visits.

[[Page 38384]]

40221.............................. All Episodes, 20+ Therapy C2F2S1 1.9942
Visits.
40231.............................. All Episodes, 20+ Therapy C2F3S1 2.0767
Visits.
40311.............................. All Episodes, 20+ Therapy C3F1S1 2.1750
Visits.
40321.............................. All Episodes, 20+ Therapy C3F2S1 2.2319
Visits.
40331.............................. All Episodes, 20+ Therapy C3F3S1 2.3144
Visits.
----------------------------------------------------------------------------------------------------------------

To ensure the changes to the case-mix weights are implemented in a
budget neutral manner, we propose to apply a case-mix budget neutrality
factor to the CY 2015 national, standardized 60-day episode payment
rate (see section III.D.4. of this proposed rule). The case-mix budget
neutrality factor is calculated as the ratio of total payments when CY
2015 case-mix weights are applied to CY 2013 utilization (claims) data
to total payments when CY 2014 case-mix weights are applied to CY 2013
utilization data. This produces the proposed case-mix budget neutrality
factor for CY 2015 of 1.0237. We note that the CY 2013 data used to
develop the proposed case-mix weights is preliminary (CY 2013 claims
data as of December 31, 2013) and we propose to update the case-mix
weights with more complete CY 2013 data (as of June 30, 2014) in the
final rule. Therefore, the points associated with each of the grouper
variables, the new clinical and functional thresholds, and the CY 2015
case-mix weights may change between the CY 2015 HH PPS proposed and
final rules.
Section 1895(b)(3)(B)(iv) of the Act gives CMS the authority to
implement payment reductions for nominal case-mix growth (that is,
changes in case-mix that are not related to actual changes in patient
characteristics over time). Previously, we accounted for nominal case-
mix growth from 2000 to 2009 through case-mix reductions implemented
from 2008 through 2013 (76 FR 68528-68543). In the CY 2013 HH PPS
proposed rule, we stated that we found that 15.97 percent of the total
case-mix change was real from 2000 to 2010 (77 FR 41553). In the CY
2014 HH PPS final rule, we used 2012 claims data to rebase payments (78
FR 72277). Since we were resetting the payment amounts with 2012 data,
we did not take into account nominal case-mix growth from 2009 through
2012.
For this proposed rule, we examined case-mix growth from CY 2012 to
CY 2013 using CY 2012 and preliminary CY 2013 claims data. In applying
the 15.97 percent estimate of real case-mix growth to the total
estimated case-mix growth from CY 2012 to CY 2013 (2.37 percent), we
estimate that a case-mix reduction of 2.00 percent, to account for
nominal case-mix growth, would be warranted. We considered adjusting
the case-mix budget neutrality factor to take into account the 2.00
percent growth in nominal case-mix, which would result in a case-mix
budget neutrality adjustment of 1.0037 rather than 1.0237. However, we
are proposing to apply the full 1.0237 case-mix budget neutrality
factor to the national, standardized 60-day episode payment rate. We
will continue to monitor case-mix growth and may consider whether to
propose nominal case-mix reductions in future rulemaking.

D. Proposed CY 2015 Rate Update

1. Proposed CY 2015 Home Health Market Basket Update
Section 1895(b)(3)(B) of the Act, as amended by section 3401(e) of
the Affordable Care Act, adds new clause (vi) which states, ``After
determining the home health market basket percentage increase . . . the
Secretary shall reduce such percentage . . . for each of 2011, 2012,
and 2013, by 1 percentage point. The application of this clause may
result in the home health market basket percentage increase under
clause (iii) being less than 0.0 for a year, and may result in payment
rates under the system under this subsection for a year being less than
such payment rates for the preceding year.'' Therefore, as mandated by
the Affordable Care Act, for CYs 2011, 2012, and 2013, the HH market
basket update was reduced by 1 percentage point.
Section 1895(b)(3)(B) of the Act requires that the standard
prospective payment amounts for CY 2015 be increased by a factor equal
to the applicable HH market basket update for those HHAs that submit
quality data as required by the Secretary. The proposed HH PPS market
basket update for CY 2015 is 2.6 percent. This is based on Global
Insight Inc.'s first quarter 2014 forecast of the 2010-based HH market
basket, with historical data through the fourth quarter of 2013. A
detailed description of how we derive the HHA market basket is
available in the CY 2013 HH PPS final rule (77 FR 67080-67090).
For CY 2015, section 3401(e) of the Affordable Care Act, requires
that, in CY 2015 (and in subsequent calendar years), the market basket
percentage under the HHA prospective payment system as described in
section 1895(b)(3)(B) of the Act be annually adjusted by changes in
economy-wide productivity. The statute defines the productivity
adjustment, described in section 1886(b)(3)(B)(xi)(II) of the Act, to
be equal to the 10-year moving average of change in annual economy-wide
private nonfarm business multifactor productivity (MFP) (as projected
by the Secretary for the 10-year period ending with the applicable
fiscal year, calendar 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 http://www.bls.gov/mfp to obtain the BLS
historical published MFP data. We note that the proposed methodology
for calculating and applying the MFP adjustment to the HHA payment
update is similar to the methodology used in other Medicare provider
payment systems as required by section 3401 of the Affordable Care Act.
The projection of MFP is currently produced by IHS Global Insight,
Inc.'s (IGI), an economic forecasting firm. To generate a forecast of
MFP, IGI replicated the MFP measure calculated by the BLS using a
series of proxy variables derived from IGI's U.S. macroeconomic models.
These models take into account a very broad range of factors that
influence the total U.S. economy. IGI forecasts the underlying proxy
components such as gross domestic product (GDP), capital, and labor
inputs required to estimate MFP and then combines those projections
according to the BLS methodology. In Table 12, we identify each of the
major

[[Page 38385]]

MFP component series employed by the BLS to measure MFP. We also
provide the corresponding concepts forecasted by IGI and determined to
be the best available proxies for the BLS series.

Table 12--Multifactor Productivity Component Series Employed by the
Bureau of Labor Statistics and IHS Global Insight
------------------------------------------------------------------------
BLS series IGI series
------------------------------------------------------------------------
Real value-added output................... Non-housing non-government
non-farm real GDP.
Private non-farm business sector labor Hours of all persons in
input. private non-farm
establishments adjusted for
labor composition.
Aggregate capital inputs.................. Real effective capital stock
used for full employment
GDP.
------------------------------------------------------------------------

IGI found that the historical growth rates of the BLS components
used to calculate MFP and the IGI components identified are consistent
across all series and therefore suitable proxies for calculating MFP.
For more information regarding the BLS method for estimating
productivity, please see the following link: http://www.bls.gov/mfp/mprtech.pdf.
During the development of this proposed rule, the BLS published a
historical time series of private nonfarm business MFP for 1987 through
2012. Using this historical MFP series and the IGI forecasted series,
IGI has developed a forecast of MFP for 2013 through 2024, as described
below.
To create a forecast of the BLS' MFP index, the forecasted annual
growth rates of the ``non-housing, nongovernment, non-farm, real GDP,''
``hours of all persons in private nonfarm establishments adjusted for
labor composition,'' and ``real effective capital stock'' series
(ranging from 2013 to 2024) are used to ``grow'' the levels of the
``real value-added output,'' ``private non-farm business sector labor
input,'' and ``aggregate capital input'' series published by the BLS.
Projections of the ``hours of all persons'' measure are calculated
using the difference between the projected growth rates of real output
per hour and real GDP. This difference is then adjusted to account for
changes in labor composition in the forecast interval. Using these
three key concepts, MFP is derived by subtracting the contribution of
labor and capital inputs from output growth. However, to estimate MFP,
we need to understand the relative contributions of labor and capital
to total output growth. Therefore, two additional measures are needed
to operationalize the estimation of the IGI MFP projection: Labor
compensation and capital income. The sum of labor compensation and
capital income represents total income. The BLS calculates labor
compensation and capital income (in current dollar terms) to derive the
nominal values of labor and capital inputs. IGI uses the
``nongovernment total compensation'' and ``flow of capital services
from the total private non-residential capital stock'' series as
proxies for the BLS' income measures. These two proxy measures for
income are divided by total income to obtain the shares of labor
compensation and capital income to total income. To estimate labor's
contribution and capital's contribution to the growth in total output,
the growth rates of the proxy variables for labor and capital inputs
are multiplied by their respective shares of total income. These
contributions of labor and capital to output growth is subtracted from
total output growth to calculate the ``change in the growth rates of
multifactor productivity:''

MFP = Total output growth - ((labor input growth * labor compensation
share) + (capital input growth * capital income share))

The change in the growth rates (also referred to as the compound
growth rates) of the IGI MFP are multiplied by 100 to calculate the
percent change in growth rates (the percent change in growth rates are
published by the BLS for its historical MFP measure). Finally, the
growth rates of the IGI MFP are converted to index levels to be
consistent with the BLS' methodology. For benchmarking purposes, the
historical growth rates of IGI's proxy variables were used to estimate
a historical measure of MFP, which was compared to the historical MFP
estimate published by the BLS. The comparison revealed that the growth
rates of the components were consistent across all series, and
therefore validated the use of the proxy variables in generating the
IGI MFP projections. The resulting MFP index was then interpolated to a
quarterly frequency using the Bassie method for temporal
disaggregation. The Bassie technique utilizes an indicator (pattern)
series for its calculations. IGI uses the index of output per hour
(published by the BLS) as an indicator when interpolating the MFP
index.
As described previously, the proposed CY 2015 HHA market basket
percentage update would be 2.6 percent. Section 3401(e) of the
Affordable Care Act amends section 1895(b)(3)(B) of the Act by adding a
new clause, which requires that after establishing the percentage
update for calendar year 2015 (and each subsequent year), ``the
Secretary shall reduce such percentage by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II)'' (which we refer to as the
multifactor productivity adjustment or MFP adjustment).
To calculate the MFP-adjusted update for the HHA market basket, we
propose that the MFP percentage adjustment be subtracted from the CY
2015 market basket update calculated using the CY 2010-based HHA market
basket. We propose that the end of the 10-year moving average of
changes in the MFP should coincide with the end of the appropriate CY
update period. Since the market basket update is reduced by the MFP
adjustment to determine the annual update for the HH PPS, we believe it
is appropriate for the data and time period associated with both
components of the calculation (the market basket and the productivity
adjustment) to end on December 15, 2015, so that changes in market
conditions are aligned.
Therefore, for the CY 2015 update, we propose that the MFP
adjustment be calculated as the 10-year moving average of changes in
MFP for the period ending December 31, 2015. We propose to round the
final annual adjustment to the one-tenth of one percentage point level
up or down as applicable according to conventional rounding rules (that
is, if the number we are rounding is followed by 5, 6, 7, 8, or 9, we
will round the number up; if the number we are rounding is followed by
1, 2, 3, or 4, we will round the number down).
The market basket percentage we are proposing for CY 2015 for the
HHA market basket is based on the 1st quarter 2014 forecast of the CY
2010-based HHA market basket update, which is estimated to be 2.6
percent. This market basket percentage would then be reduced by the MFP
adjustment (the 10-year moving average of MFP for the period ending
December 31, 2015) of 0.4 percent, which is calculated as described
above and based on IGI's 1st quarter 2014 forecast. The resulting MFP-
adjusted HHA market basket update is equal to 2.2 percent, or 2.6
percent less 0.4 percent. We propose that if more recent data are
subsequently available (for example, a more recent estimate of the
market basket and MFP adjustment), we would use such data, if
appropriate, to determine the CY 2015 market basket update and MFP
adjustment in the CY 2015 HHA PPS final rule.

[[Page 38386]]

Section 1895(b)(3)(B) of the Act requires that the home health
market basket percentage increase be decreased by 2 percentage points
for those HHAs that do not submit quality data as required by the
Secretary. For HHAs that do not submit the required quality data for CY
2015, the home health market basket update will be 0.2 percent (2.2
percent minus 2 percent). As noted previously, the home health market
basket was rebased and revised in CY 2013. A detailed description of
how we derive the HHA market basket is available in the CY 2013 HH PPS
final rule (77 FR 67080, 67090).
2. Home Health Care Quality Reporting Program (HH QRP)
a. General Considerations Used for Selection of Quality Measures for
the HH QRP
The successful development of the Home Health Quality Reporting
Program (HH QRP) that promotes the delivery of high quality healthcare
services is our paramount concern. We seek to adopt measures for the HH
QRP that promote more efficient and safer care. Our measure selection
activities for the HH QRP takes into consideration input we receive
from the Measure Applications Partnership (MAP), convened by the
National Quality Forum (NQF) as part of a pre-rulemaking process that
we have established and are required to follow under section 1890A of
the Act. The MAP is a public-private partnership comprised of multi-
stakeholder groups convened for the primary purpose of providing input
to CMS on the selection of certain categories of quality and efficiency
measures, as required by section 1890A(a)(3) of the Act. By February
1st of each year, the NQF must provide that input to CMS.
More details about the pre-rulemaking process can be found at
http://www.qualityforum.org/map.
MAP reports to view and download are available at http://www.qualityforum.org/Setting_Priorities/Partnership/MAP_Final_Reports.aspx.
Our measure development and selection activities for the HH QRP
take into account national priorities, such as those established by the
National Priorities Partnership (http://www.qualityforum.org/Setting_Priorities/NPP/National_Priorities_Partnership.aspx), the Department
of Health & Human Services (HHS) Strategic Plan (http://www.hhs.gov/secretary/about/priorities/priorities.html, the National Quality
Strategy (NQS) (http://www.ahrq.gov/workingforquality/reports.htm), and
the CMS Quality Strategy (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html).
To the extent practicable, we have sought to adopt measures that
have been endorsed by the national consensus organization under
contract to endorse standardized healthcare quality measures pursuant
to section 1890 of the Act, recommended by multi-stakeholder
organizations, and developed with the input of patients, providers,
purchasers/payers, and other stakeholders. At this time, the National
Quality Forum (NQF) is the national consensus organization that is
under contract with HHS to provide review and endorsement of quality
measures.
b. Background and Quality Reporting Requirements
Section 1895(b)(3)(B)(v)(II) of the Act states that ``each home
health agency shall submit to the Secretary such data that the
Secretary determines are appropriate for the measurement of health care
quality. Such data shall be submitted in a form and manner, and at a
time, specified by the Secretary for purposes of this clause.''
In addition, section 1895(b)(3)(B)(v)(I) of the Act states that
``for 2007 and each subsequent year, in the case of a home health
agency that does not submit data to the Secretary in accordance with
subclause (II) with respect to such a year, the home health market
basket percentage increase applicable under such clause for such year
shall be reduced by 2 percentage points.'' This requirement has been
codified in regulations at Sec. 484.225(i). HHAs that meet the quality
data reporting requirements are eligible for the full home health (HH)
market basket percentage increase. HHAs that do not meet the reporting
requirements are subject to a 2 percentage point reduction to the HH
market basket increase.
Section 1895(b)(3)(B)(v)(III) of the Act further states that
``[t]he Secretary shall establish procedures for making data submitted
under subclause (II) available to the public. Such procedures shall
ensure that a home health agency has the opportunity to review the data
that is to be made public with respect to the agency prior to such data
being made public.''
Medicare home health regulations, as codified at Sec. 484.250(a),
require HHAs to submit OASIS assessments and Home Health Care Consumer
Assessment of Healthcare Providers and Systems Survey (HH
CAHPS[supreg]) data to meet the quality reporting requirements of
section 1895(b)(3)(B)(v) of the Act. We provide quality measure data to
HHAs via the Certification and Survey Provider Enhanced Reports (CASPER
reports) which are available on the CMS Health Care Quality Improvement
System (QIES). A subset of the HH quality measures has been publicly
reported on the Home Health Compare (HH Compare) Web site since 2003.
The CY 2012 HH PPS final rule (76 FR 68576), identifies the current HH
QRP measures. The selected measures that are made available to the
public can be viewed on the HH Compare Web site located at http://www.medicare.gov/HHCompare/Home.asp. As stated in the CY 2012 and
CY2013 HH PPS final rules (76 FR 68575 and 77 FR 67093, respectively),
we finalized that we will also use measures derived from Medicare
claims data to measure HH quality.
In the CY 2014 HH PPS final rule, we finalized a proposal to add
two claims-based measures to the HH QRP, and also stated that we would
begin reporting the data from these measures to HHAs beginning in CY
2014. These claims based measures are: (1) Rehospitalization during the
first 30 days of HH; and (2) Emergency Department Use without Hospital
Readmission during the first 30 days of HH. Also, in this rule, we
finalized our proposal to reduce the number of process measures
reported on the CASPER reports by eliminating the stratification by
episode length for 9 process measures. While no timeframe was given for
the removal of these measures, we have scheduled them for removal from
the CASPER folders in October 2014. In addition, five short stay
measures which had previously been reported on Home Health Compare were
recently removed from public reporting and replaced with non-stratified
``all episodes of care'' versions of these measures.
c. OASIS Data Submission and OASIS Data for Annual Payment Update
(1) Statutory Authority
The Home Health conditions of participation (CoPs) at Sec.
484.55(d) require that the comprehensive assessment must be updated and
revised (including the administration of the OASIS) no less frequently
than: (1) The last 5 days of every 60 days beginning with the start of
care date, unless there is a beneficiary elected transfer, significant
change in condition, or discharge and return to the same HHA during the
60-day episode; (2) within 48 hours of the patient's return to the home
from a hospital admission of 24 hours

[[Page 38387]]

or more for any reason other than diagnostic tests; and (3) at
discharge.
It is important to note that to calculate quality measures from
OASIS data, there must be a complete quality episode, which requires
both a Start of Care (initial assessment) or Resumption of Care OASIS
assessment and a Transfer or Discharge OASIS assessment. Failure to
submit sufficient OASIS assessments to allow calculation of quality
measures, including transfer and discharge assessments, is failure to
comply with the CoPs.
HHAs do not need to submit OASIS data for those patients who are
excluded from the OASIS submission requirements. As described in the
December 23, 2005 Medicare and Medicaid Programs: Reporting Outcome and
Assessment Information Set Data as Part of the Conditions of
Participation for Home Health Agencies final rule (70 FR 76202), we
define the exclusion as those patients:
Receiving only non-skilled services;
For whom neither Medicare nor Medicaid is paying for HH
care (patients receiving care under a Medicare or Medicaid Managed Care
Plan are not excluded from the OASIS reporting requirement);
Receiving pre- or post-partum services; or
Under the age of 18 years.
As set forth in the CY 2008 HH PPS final rule (72 FR 49863), HHAs
that become Medicare-certified on or after May 31 of the preceding year
are not subject to the OASIS quality reporting requirement nor any
payment penalty for quality reporting purposes for the following year.
For example, HHAs certified on or after May 31, 2013 are not subject to
the 2 percentage point reduction to their market basket update for CY
2014. These exclusions only affect quality reporting requirements and
do not affect the HHA's reporting responsibilities as announced in the
December 23, 2005 final rule, ``Medicare and Medicaid Programs;
Reporting Outcome and Assessment Information Set Data as Part of the
Conditions of Participation for Home Health Agencies'' (70 FR 76202).
(2) Home Health Quality Reporting Program Requirements for CY 2015
Payment and Subsequent Years
In the CY 2014 Home Health Final rule (78 FR 72297), we finalized a
proposal to consider OASIS assessments submitted by HHAs to CMS in
compliance with HH CoPs and Conditions for Payment for episodes
beginning on or after July 1, 2012, and before July 1, 2013 as
fulfilling one portion of the quality reporting requirement for CY
2014. In addition, we finalized a proposal to continue this pattern for
each subsequent year beyond CY 2014, considering OASIS assessments
submitted for episodes beginning on July 1st of the calendar year 2
years prior to the calendar year of the Annual Payment Update (APU)
effective date and ending June 30th of the calendar year 1 year prior
to the calendar year of the APU effective date as fulfilling the OASIS
portion of the HH quality reporting requirement.
(3) Establishing a ``Pay-for-Reporting'' Performance Requirement for
Submission of OASIS Quality Data
Section 1895(b)(3)(B)(v)(I) of the Act states that ``for 2007 and
each subsequent year, in the case of a home health agency that does not
submit data to the Secretary in accordance with subclause (II) with
respect to such a year, the home health market basket percentage
increase applicable under such clause for such year shall be reduced by
2 percentage points.'' This ``pay-for-reporting'' requirement was
implemented on January 1, 2007. However, to date, the quantity of OASIS
assessments each HHA must submit to meet this requirement has never
been proposed and finalized through rulemaking or through the sub-
regulatory process. We believe that this matter should be addressed for
several reasons.
We believe that defining a more explicit performance requirement
for the submission of OASIS data by HHAs would better meet section
5201(c)(2) of the Deficit Reduction Act of 2005 (DRA), which requires
that ``each home health agency shall submit to the Secretary such data
that the Secretary determines are appropriate for the measurement of
health care quality. Such data shall be submitted in a form and manner,
and at a time, specified by the Secretary for purposes of this
clause.''
In February 2012, the Department of Health & Human Services Office
of the Inspector General (OIG) performed a study to: (1) Determine the
extent to which home health agencies (HHAs) meet Federal reporting
requirements for the Outcome and Assessment Information Set (OASIS)
data; (2) to determine the extent to which states meet federal
reporting requirements for OASIS data; and (3) to determine the extent
to which the Centers for Medicare & Medicaid Services (CMS) oversees
the accuracy and completeness of OASIS data submitted by HHAs. In a
report entitled, ``Limited Oversight of Home Health Agency OASIS
Data,'' \13\ the OIG stated their finding that ``CMS did not ensure the
accuracy or completeness of OASIS data.'' The OIG recommended that we
``identify all HHAs that failed to submit OASIS data and apply the 2-
percent payment reduction to them''. We believe that establishing a
performance requirement for submission of OASIS quality data would be
responsive to the recommendations of the OIG.
---------------------------------------------------------------------------

\13\ http://oig.hhs.gov/oei/reports/oei-01-10-00460.asp.
---------------------------------------------------------------------------

In response to these requirements and the OIG report, we directed
one of our contractors (the University of Colorado, Anschutz Medical
Campus) to design a pay-for-reporting performance system model that
could accurately measure the level of an HHA's submission of OASIS
quality data. After review and analysis of several years of OASIS data,
the researchers at the University of Colorado were able to develop a
performance system which is driven by the principle that each HHA would
be expected to submit a minimum set of two ``matching'' assessments for
each patient admitted to their agency. These matching assessments
together create what is considered a ``quality episode of care'', which
would ideally consist of a Start of Care (SOC) or Resumption of Care
(ROC) assessment and a matching End of Care (EOC) assessment. However,
the researchers at the University of Colorado determined that there are
several scenarios that could meet this ``matching assessment
requirement'' of the new pay-for-reporting performance requirement.
These scenarios have been defined as ``quality assessments'', which are
defined as assessments that create a quality episode of care during the
reporting period or could create a quality episode if the reporting
period were expanded to an earlier reporting period or into the next
reporting period.
Seven types of assessments submitted by an HHA fit this definition
of a quality assessment. These are:
A Start of Care (SOC) or Resumption of Care (ROC)
assessment that has a matching End of Care (EOC) assessment. EOC
assessments are assessments that are conducted at transfer to an
inpatient facility (with or without discharge), death, or discharge
from home health care. These two assessments (the SOC or ROC assessment
and the EOC assessment) create a regular quality episode of care and
both count as quality assessments.
An SOC/ROC assessment that could begin an episode of care,
but occurs in the last 60 days of the performance

[[Page 38388]]

period. This is labeled as a ``Late SOC/ROC'' quality assessment.
An EOC assessment that could end an episode of care that began in
the previous reporting period, (that is, an EOC that occurs in the
first 60 days of the performance period.) This is labeled as an ``Early
EOC'' quality assessment.
An SOC/ROC assessment that is followed by one or more
follow-up assessments, the last of which occurs in the last 60 days of
the performance period. This is labeled as an ``SOC/ROC Pseudo
Episode'' quality assessment.
An EOC assessment is preceded by one or more Follow-up
assessments, the last of which occurs in the first 60 days of the
performance period. This is labeled an ``EOC Pseudo Episode'' quality
assessment.
An SOC/ROC assessment that is part of a known one-visit
episode. This is labeled as a ``One-visit episode'' quality assessment.
SOC, ROC, and EOC assessments that do not meet any of
these definitions are labeled as ``Non-Quality'' assessments.
Follow-up assessments (that is, where the M0100 Reason for
Assessment = `04' or `05') are considered ``Neutral'' assessments and
do not count toward or against the pay for reporting performance
requirement.
Compliance with this performance requirement can be measured
through the use of an uncomplicated mathematical formula. This Pay for
Reporting performance requirement metric has been titled as the
``Quality Assessments Only'' (QAO) formula because only those OASIS
assessments that contribute, or could contribute, to creating a quality
episode of care are included in the computation. The formula based on
this definition is as follows:
[GRAPHIC] [TIFF OMITTED] TP07JY14.001

Our ultimate goal is to require all HHAs to achieve a Pay-for-
Reporting performance requirement compliance rate of 90 percent or
more, as calculated using the QAO metric illustrated above. However, we
propose to implement this performance requirement in an incremental
fashion over a 3 year period. We propose to require each HHA to reach a
compliance rate of 70 percent or better during the first reporting
period \14\ that the new Pay-for-Reporting performance requirement is
implemented. We further propose to increase the Pay-for-Reporting
performance requirement by 10 percent in the second reporting period,
and then by an additional 10 percent in the third reporting period
until a pay-for-reporting performance requirement of 90 percent is
reached.
---------------------------------------------------------------------------

\14\ The term ``reporting period'' is defined as the submission
of OASIS assessments for episodes between July 1 (of the calendar
year two years prior to the calendar year of the APU effective date)
through the following June 30th (of the calendar year one year prior
to the calendar year of the APU effective date) each year.
---------------------------------------------------------------------------

To summarize, we propose to implement the pay-for- reporting
performance requirement beginning with all episodes of care that occur
on or after July 1, 2015, in accordance with the following schedule:
For episodes beginning on or after July 1st, 2015 and
before June 30th, 2016, HHAs must score at least 70 percent on the QAO
metric of pay-for-reporting performance or be subject to a 2 percentage
point reduction to their market basket update for CY 2017.
For episodes beginning on or after July 1st, 2016 and
before June 30th, 2017, HHAs must score at least 80 percent on the QAO
metric of pay-for-reporting performance or be subject to a 2 percentage
point reduction to their market basket update for CY 2018.
For episodes beginning on or after July 1st, 2017, and
thereafter, and before June 30th, 2018 and thereafter, HHAs must score
at least 90 percent on the QAO metric of pay-for-reporting performance
or be subject to a 2 percentage point reduction to their market basket
update for CY 2019, and each subsequent year thereafter.
We solicit public comment on our proposal to implement the Pay-for-
Reporting performance requirement, as described previously, for the
Home Health Quality Reporting Program.
d. Updates to HH QRP Measures Which Are Made as a Result of Review by
the NQF Process
Section 1895(b)(3)(B)(v)(II) of the Act generally requires the
Secretary to adopt measures that have been endorsed by the entity with
a contract under section 1890(a) of the Act. This contract is currently
held by the NQF. The NQF is a voluntary consensus standard-setting
organization with a diverse representation of consumer, purchaser,
provider, academic, clinical, and other health care stakeholder
organizations. The NQF was established to standardize health care
quality measurement and reporting through its consensus development
process.\15\
---------------------------------------------------------------------------

\15\ For more information about the NQF Consensus Development
Process, please visit the NQF Web site using the following link:
http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx.
---------------------------------------------------------------------------

The NQF undertakes to: (1) Review new quality measures and national
consensus standards for measuring and publicly reporting on
performance; (2) provide for annual measure maintenance updates to be
submitted by the measure steward for endorsed quality measures; (3)
provide for measure maintenance endorsement on a 3-year cycle; (4)
conduct a required follow-up review of measures with time limited
endorsement for consideration of full endorsement; and (5) conduct ad
hoc reviews of endorsed quality measures, practices, consensus
standards, or events when there is adequate justification for a review.
In the normal course of measure maintenance, the NQF solicits
information from measure stewards for annual reviews to review measures
for continued endorsement in a specific 3-year cycle. In this measure
maintenance process, the measure steward is responsible for updating
and maintaining the currency and relevance of the measure and for
confirming existing specifications to the NQF on an annual basis. As
part of the ad hoc review process, the ad hoc review requester and the
measure steward are responsible for submitting evidence for review by a
NQF Technical Expert panel which, in turn, provides input to the
Consensus Standards Approval Committee which then makes a decision on
endorsement status and/or specification changes for the measure,
practice, or event.
Through the NQF's measure maintenance process, the NQF endorsed
measures are sometimes updated to incorporate changes that we believe
do not substantially change the nature of the measure. With respect to
what constitutes a substantive versus a non-substantive change, we
expect to make this determination on a measure-by-measure basis.
Examples of such non-substantive changes might include updated
diagnosis or procedure codes, medication updates for categories of

[[Page 38389]]

medications, broadening of age ranges, and changes to exclusions for a
measure. We believe that non-substantive changes may include updates to
measures based upon changes to guidelines upon which the measures are
based. These types of maintenance changes are distinct from more
substantive changes to measures that result in what can be considered
new or different measures, and that they do not trigger the same agency
obligations under the Administrative Procedure Act.
We are proposing that, if the NQF updates an endorsed measure that
we have adopted for the HH QRP in a manner that we consider to not
substantially change the nature of the measure, we would use a sub-
regulatory process to incorporate those updates to the measure
specifications that apply to the program. Specifically, we would revise
the information that is posted on the CMS Home Health Quality
Initiatives Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/HHQIQualityMeasures.html so that it clearly identifies the updates and
provides links to where additional information on the updates can be
found. In addition, we would refer HHAs to the NQF Web site for the
most up-to date information about the quality measures (http://www.qualityforum.org/). We would provide sufficient lead time for HHAs
to implement the changes where changes to the data collection systems
would be necessary.
We would continue to use the rulemaking process to adopt changes to
measures that we consider to substantially change the nature of the
measure. Examples of changes that we might consider to be substantive
would be those in which the changes are so significant that the measure
is no longer the same measure, or when a standard of performance
assessed by a measure becomes more stringent, such as changes in
acceptable timing of medication, procedure/process, test
administration, or expansion of the measure to a new setting. We
believe that our proposal adequately balances our need to incorporate
NQF updates to NQF endorsed measures used in the HH QRP in the most
expeditious manner possible, while preserving the public's ability to
comment on updates to measures that so fundamentally change an endorsed
measure that it is no longer the same measure that we originally
adopted.
We note that a similar policy was adopted for the Hospital IQR
Program, the PPS-Exempt Cancer Hospital (PCH) Quality Reporting
Program, the Long-Term Care Hospital Quality Reporting (LTCHQR)
Program, the Inpatient Rehabilitation Facility Quality Reporting
Program (IRF QRP) and the Inpatient Psychiatric Facility (IPF) Quality
Reporting Program.
We invite public comment on our proposal to adopt a policy in which
NQF changes to a measure that are non-substantive in nature will be
adopted using a sub-regulatory process and NQF changes that are
substantive in nature will be adopted through the rulemaking process.
e. Home Health Care CAHPS[supreg] Survey (HHCAHPS)
In the CY 2014 HH PPS final rule (78 FR 72294), we stated that the
HH quality measures reporting requirements for Medicare-certified
agencies includes the Home Health Care CAHPS[supreg] (HHCAHPS) Survey
for the CY 2014 APU. We maintained the stated HHCAHPS data requirements
for CY 2014 set out in previous rules, for the continuous monthly data
collection and quarterly data submission of HHCAHPS data.
(1) Background and Description of HHCAHPS
As part of the HHS Transparency Initiative, we implemented a
process to measure and publicly report patient experiences with home
health care, using a survey developed by the Agency for Healthcare
Research and Quality's (AHRQ's) Consumer Assessment of Healthcare
Providers and Systems (CAHPS[supreg]) program and endorsed by the NQF
in March 2009 (NQF Number 0517). The HHCAHPS survey is part of a family
of CAHPS[supreg] surveys that asks patients to report on and rate their
experiences with health care. The Home Health Care CAHPS[supreg]
(HHCAHPS) survey presents home health patients with a set of
standardized questions about their home health care providers and about
the quality of their home health care.
Prior to this survey, there was no national standard for collecting
information about patient experiences that will enable valid
comparisons across all HHAs. The history and development process for
HHCAHPS has been described in previous rules and is also available on
the official HHCAHPS Web site at https://homehealthcahps.org and in the
annually-updated HHCAHPS Protocols and Guidelines Manual, which is
downloadable from https://homehealthcahps.org.
For public reporting purposes, we report five measures from the
HHCAHPS Survey--three composite measures and two global ratings of care
that are derived from the questions on the HHCAHPS survey. The publicly
reported data are adjusted for differences in patient mix across HHAs.
We update the HHCAHPS data on Home Health Compare on www.medicare.gov
quarterly. Each HHCAHPS composite measure consists of four or more
individual survey items regarding one of the following related topics:
Patient care (Q9, Q16, Q19, and Q24);
Communications between providers and patients (Q2, Q15,
Q17, Q18, Q22, and Q23); and
Specific care issues on medications, home safety, and pain
(Q3, Q4, Q5, Q10, Q12, Q13, and Q14).
The two global ratings are the overall rating of care given by the
HHA's care providers (Q20), and the patient's willingness to recommend
the HHA to family and friends (Q25).
The HHCAHPS survey is currently available in English, Spanish,
Chinese, Russian, and Vietnamese. The OMB number on these surveys is
the same (0938-1066). All of these surveys are on the Home Health Care
CAHPS[supreg] Web site, https://homehealthcahps.org. We will continue
to consider additional language translations of the HHCAHPS in response
to the needs of the home health patient population.
All of the requirements about home health patient eligibility for
the HHCAHPS survey and conversely, which home health patients are
ineligible for the HHCAHPS survey are delineated and detailed in the
HHCAHPS Protocols and Guidelines Manual, which is downloadable at
https://homehealthcahps.org. Home health patients are eligible for
HHCAHPS if they received at least two skilled home health visits in the
past 2 months, which are paid for by Medicare or Medicaid.
Home health patients are ineligible for inclusion in HHCAHPS
surveys if one of these conditions pertains to them:
Are under the age of 18;
Are deceased prior to the date the sample is pulled;
Receive hospice care;
Receive routine maternity care only;
Are not considered survey eligible because the state in
which the patient lives restricts release of patient information for a
specific condition or illness that the patient has; or
No Publicity patients, defined as patients who on their
own initiative at their first encounter with the HHAs make it very
clear that no one outside of the agencies can be advised of their
patient status, and no one outside of the HHAs can contact them for any
reason.

[[Page 38390]]

We stated in previous rules that Medicare-certified HHAs are
required to contract with an approved HHCAHPS survey vendor. This
requirement continues, and Medicare-certified agencies also must
provide on a monthly basis a list of their patients served to their
respective HHCAHPS survey vendors. Agencies are not allowed to
influence at all how their patients respond to the HHCAHPS survey.
As previously required, HHCAHPS survey vendors are required to
attend introductory and all update trainings conducted by CMS and the
HHCAHPS Survey Coordination Team, as well as to pass a post-training
certification test. We have approximately 30 approved HHCAHPS survey
vendors. The list of approved HHCAHPS survey vendors is available at
https://homehealthcahps.org.
(2) HHCAHPS Oversight Activities
We stated in prior final rules that all approved HHCAHPS survey
vendors are required to participate in HHCAHPS oversight activities to
ensure compliance with HHCAHPS protocols, guidelines, and survey
requirements. The purpose of the oversight activities is to ensure that
approved HHCAHPS survey vendors follow the HHCAHPS Protocols and
Guidelines Manual. As stated previously in the five prior final rules
to this proposed rule, all HHCAHPS approved survey vendors must develop
a Quality Assurance Plan (QAP) for survey administration in accordance
with the HHCAHPS Protocols and Guidelines Manual. An HHCAHPS survey
vendor's first QAP must be submitted within 6 weeks of the data
submission deadline date after the vendor's first quarterly data
submission. The QAP must be updated and submitted annually thereafter
and at any time that changes occur in staff or vendor capabilities or
systems. A model QAP is included in the HHCAHPS Protocols and
Guidelines Manual. The QAP must include the following:
Organizational Background and Staff Experience;
Work Plan;
Sampling Plan;
Survey Implementation Plan;
Data Security, Confidentiality and Privacy Plan; and
Questionnaire Attachments
As part of the oversight activities, the HHCAHPS Survey
Coordination Team conducts on-site visits to all approved HHCAHPS
survey vendors. The purpose of the site visits is to allow the HHCAHPS
Coordination Team to observe the entire HHCAHPS Survey implementation
process, from the sampling stage through file preparation and
submission, as well as to assess data security and storage. The HHCAHPS
Survey Coordination Team reviews the HHCAHPS survey vendor's survey
systems, and assesses administration protocols based on the HHCAHPS
Protocols and Guidelines Manual posted at https://homehealthcahps.org.
The systems and program site visit review includes, but is not limited
to the following:
Survey management and data systems;
Printing and mailing materials and facilities;
Telephone call center facilities;
Data receipt, entry and storage facilities; and
Written documentation of survey processes.
After the site visits, HHCAHPS survey vendors are given a defined
time period in which to correct any identified issues and provide
follow-up documentation of corrections for review. HHCAHPS survey
vendors are subject to follow-up site visits on an as-needed basis.
In the CY 2013 HH PPS final rule (77 FR 67094, 67164), we codified
the current guideline that all approved HHCAHPS survey vendors fully
comply with all HHCAHPS oversight activities. We included this survey
requirement at Sec. 484.250(c)(3).
(3) HHCAHPS Requirements for the CY 2015 APU
In the CY 2014 HH PPS final rule (78 FR 72294), we stated that for
the CY 2015 APU, we will require continued monthly HHCAHPS data
collection and reporting for 4 quarters. The data collection period for
CY 2015 APU includes the second quarter 2013 through the first quarter
2014 (the months of April 2013 through March 2014). Although these
dates are past, we wished to state them in this proposed rule so that
HHAs are again reminded of what months constituted the requirements for
the CY 2015 APU. HHAs are required to submit their HHCAHPS data files
to the HHCAHPS Data Center for the HHCAHPS data from the first quarter
of 2014 data by 11:59 p.m., e.d.t. on July 17, 2014. This deadline is
firm; no exceptions are permitted.
(4) HHCAHPS Requirements for the CY 2016 APU
For the CY 2016 APU, we require continued monthly HHCAHPS data
collection and reporting for 4 quarters. The data collection period for
the CY 2016 APU includes the second quarter 2014 through the first
quarter 2015 (the months of April 2014 through March 2015). HHAs will
be required to submit their HHCAHPS data files to the HHCAHPS Data
Center for the second quarter 2014 by 11:59 p.m., e.d.t. on October 16,
2014; for the third quarter 2014 by 11:59 p.m., e.s.t. on January 15,
2015; for the fourth quarter 2014 by 11:59 p.m., e.d.t. on April 16,
2015; and for the first quarter 2015 by 11:59 p.m., e.d.t. on July 16,
2015. These deadlines will be firm; no exceptions will be permitted.
We will exempt HHAs receiving Medicare certification after the
period in which HHAs do their patient count (April 1, 2013 through
March 31, 2014) on or after April 1, 2014, from the full HHCAHPS
reporting requirement for the CY 2016 APU, because these HHAs will not
have been Medicare-certified throughout the period of April 1, 2013,
through March 31, 2014. These HHAs will not need to complete a HHCAHPS
Participation Exemption Request form for the CY 2016 APU.
We require that all HHAs that had fewer than 60 HHCAHPS-eligible
unduplicated or unique patients in the period of April 1, 2013 through
March 31, 2014 are exempt from the HHCAHPS data collection and
submission requirements for the CY 2016 APU, upon completion of the CY
2016 HHCAHPS Participation Exemption Request form. Agencies with fewer
than 60 HHCAHPS-eligible, unduplicated or unique patients in the period
of April 1, 2013, through March 31, 2014, will be required to submit
their patient counts on the HHCAHPS Participation Exemption Request
form for the CY 2016 APU posted on https://homehealthcahps.org on April
1, 2014, by 11:59 p.m., e.s.t. by March 31, 2015. This deadline will be
firm, as will be all of the quarterly data submission deadlines.
(5) HHCAHPS Requirements for the CY 2017 APU
For the CY 2017 APU, we require continued monthly HHCAHPS data
collection and reporting for 4 quarters. The data collection period for
the CY 2017 APU includes the second quarter 2015 through the first
quarter 2016 (the months of April 2015 through March 2016). HHAs will
be required to submit their HHCAHPS data files to the HHCAHPS Data
Center for the second quarter 2015 by 11:59 p.m., e.d.t. on October 15,
2015; for the third quarter 2015 by 11:59 p.m., e.s.t. on January 12,
2016; for the fourth quarter 2015 by 11:59 p.m., e.d.t. on April 21,
2016; and for the first quarter 2016 by 11:59 p.m., e.d.t. on July 21,
2016. These deadlines will be firm; no exceptions will be permitted.

[[Page 38391]]

We will exempt HHAs receiving Medicare certification after the
period in which HHAs do their patient count (April 1, 2014 through
March 31, 2015) on or after April 1, 2015, from the full HHCAHPS
reporting requirement for the CY 2016 APU, because these HHAs will not
have been Medicare-certified throughout the period of April 1, 2014,
through March 31, 2015. These HHAs will not need to complete a HHCAHPS
Participation Exemption Request form for the CY 2017 APU.
We require that all HHAs that had fewer than 60 HHCAHPS-eligible
unduplicated or unique patients in the period of April 1, 2014, through
March 31, 2015 are exempt from the HHCAHPS data collection and
submission requirements for the CY 2017 APU, upon completion of the CY
2017 HHCAHPS Participation Exemption Request form. Agencies with fewer
than 60 HHCAHPS-eligible, unduplicated or unique patients in the period
of April 1, 2014, through March 31, 2015, will be required to submit
their patient counts on the HHCAHPS Participation Exemption Request
form for the CY 2017 APU posted on https://homehealthcahps.org on April
1, 2015, by 11:59 p.m., e.s.t. by March 31, 2016. This deadline will be
firm, as will be all of the quarterly data submission deadlines.
(6) HHCAHPS Reconsiderations and Appeals Process
HHAs should monitor their respective HHCAHPS survey vendors to
ensure that vendors submit their HHCAHPS data on time, by accessing
their HHCAHPS Data Submission Reports on https://homehealthcahps.org.
This will help HHAs ensure that their data are submitted in the proper
format for data processing to the HHCAHPS Data Center.
We will continue HHCAHPS oversight activities as finalized in the
CY 2014 rule. In the CY 2013 HH PPS final rule (77 FR 6704, 67164), we
codified the current guideline that all approved HHCAHPS survey vendors
must fully comply with all HHCAHPS oversight activities. We included
this survey requirement at Sec. 484.250(c)(3).
We will continue the HHCAHPS reconsiderations and appeals process
that we have finalized and that we have used for prior periods for the
CY 2012, CY 2013, and CY 2014 APU determinations. We have described the
HHCAHPS reconsiderations process requirements in the Technical
Direction Letter that we send to the affected HHAs, on or about the
first Friday in September. HHAs have 30 days from their receipt of the
Technical Direction Letter informing them that they did not meet the
HHCAHPS requirements for the CY period, to send all documentation that
supports their requests for reconsideration to CMS. It is important
that the affected HHAs send in comprehensive information in their
reconsideration letter/package because we will not contact the affected
HHAs to request additional information or to clarify incomplete or
inconclusive information. If clear evidence to support a finding of
compliance is not present, the 2 percent reduction in the APU will be
upheld. If clear evidence of compliance is present, the 2 percent
reduction for the APU will be reversed. We will notify affected HHAs by
about mid-December. If we determine to uphold the 2 percent reduction,
the HHA may further appeal the 2 percent reduction via the Provider
Reimbursement Review Board (PRRB) appeals process.
(7) Summary
We are not proposing any changes to the participation requirements,
or to the requirements pertaining to the implementation of the Home
Health CAHPS[supreg] Survey (HHCAHPS). We again strongly encourage HHAs
to learn about the survey and view the HHCAHPS Survey Web site at the
official Web site for the HHCAHPS at https://homehealthcahps.org. HHAs
can also send an email to the HHCAHPS Survey Coordination Team at
[email protected], or telephone toll-free (1-866-354-0985) for more
information about HHCAHPS.
4. Home Health Wage Index
a. Background
Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the
Secretary to provide appropriate adjustments to the proportion of the
payment amount under the HH PPS that account for area wage differences,
using adjustment factors that reflect the relative level of wages and
wage-related costs applicable to the furnishing of HH services. Since
the inception of the HH PPS, we have used inpatient hospital wage data
in developing a wage index to be applied to HH payments. We propose to
continue this practice for CY 2015, as we continue to believe that, in
the absence of HH-specific wage data, using inpatient hospital wage
data is appropriate and reasonable for the HH PPS. Specifically, we
propose to continue to use the pre-floor, pre-reclassified hospital
wage index as the wage adjustment to the labor portion of the HH PPS
rates. For CY 2015, the updated wage data are for hospital cost
reporting periods beginning on or after October 1, 2010 and before
October 1, 2011 (FY 2011 cost report data).
We would apply the appropriate wage index value to the labor
portion of the HH PPS rates based on the site of service for the
beneficiary (defined by section 1861(m) of the Act as the beneficiary's
place of residence). Previously, we determined each HHA's labor market
area based on definitions of metropolitan statistical areas (MSAs)
issued by the OMB. In the CY 2006 HH PPS final rule (70 FR 68132), we
began adopting revised labor market area definitions as discussed in
the OMB Bulletin No. 03-04 (June 6, 2003). This bulletin announced
revised definitions for MSAs and the creation of micropolitan
statistical areas and core-based statistical areas (CBSAs). The
bulletin is available online at www.whitehouse.gov/omb/bulletins/b03-04.html. In adopting the CBSA geographic designations, we provided a
one-year transition in CY 2006 with a blended wage index for all sites
of service. For CY 2006, the wage index for each geographic area
consisted of a blend of 50 percent of the CY 2006 MSA-based wage index
and 50 percent of the CY 2006 CBSA-based wage index. We referred to the
blended wage index as the CY 2006 HH PPS transition wage index. As
discussed in the CY 2006 HH PPS final rule (70 FR 68132), since the
expiration of this one-year transition on December 31, 2006, we have
used the full CBSA-based wage index values.
We propose to continue to use the same methodology discussed in the
CY 2007 HH PPS final rule (71 FR 65884) to address those geographic
areas in which there are no inpatient hospitals, and thus, no hospital
wage data on which to base the calculation of the CY 2015 HH PPS wage
index. For rural areas that do not have inpatient hospitals, we will
use the average wage index from all contiguous CBSAs as a reasonable
proxy. For CY 2015, there are no rural areas that do not have inpatient
hospitals, and thus, this methodology would not be applied. For rural
Puerto Rico, we do not apply this methodology due to the distinct
economic circumstances that exist there (for example, due to the close
proximity to one another of almost all of Puerto Rico's various urban
and non-urban areas, this methodology would produce a wage index for
rural Puerto Rico that is higher than that in half of its urban areas).
Instead, we would continue to use the most recent wage index previously
available for that area. For urban areas without inpatient hospitals,
we use the average wage index of all urban areas within the state as a

[[Page 38392]]

reasonable proxy for the wage index for that CBSA. For CY 2015, the
only urban area without inpatient hospital wage data is Hinesville,
Georgia (CBSA 25980).
b. Update
On February 28, 2013, OMB issued Bulletin No. 13-01, announcing
revisions to the delineations of MSAs, Micropolitan Statistical Areas,
and CBSAs, and guidance on uses of the delineation of these areas. This
bulletin is available online at http://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf. This bulletin states that
it ``provides the delineations of all Metropolitan Statistical Areas,
Metropolitan Divisions, Micropolitan Statistical Areas, Combined
Statistical Areas, and New England City and Town Areas in the United
States and Puerto Rico based on the standards published on June 28,
2010, in the Federal Register (75 FR 37246-37252) and Census Bureau
data.''
While the revisions OMB published on February 28, 2013 are not as
sweeping as the changes made when we adopted the CBSA geographic
designations for CY 2006, the February 28, 2013 bulletin does contain a
number of significant changes. For example, there are new CBSAs, urban
counties that have become rural, rural counties that have become urban,
and existing CBSAs that have been split apart.
As discussed in the CY 2014 HH PPS final rule (78 FR 72302), the
changes made by the bulletin and their ramifications required extensive
review by CMS before using them for the HH PPS wage index. We have
completed our assessment and in the FY 2015 IPPS proposed rule (79 FR
27978), we proposed to use the most recent labor market area
delineations issued by OMB for payments for inpatient stays at general
acute care and long-term care hospitals (LTCHs). In addition, in the FY
2015 Skilled Nursing Facility (SNF) PPS proposed rule (79 FR 25767), we
proposed to use the new labor market delineations issued by OMB for
payments for SNFs. We are proposing changes to the HH PPS wage index
based on the newest OMB delineations, as described in OMB Bulletin No.
13-01.
c. Proposed Implementation of New Labor Market Delineations
We believe it is important for the HH PPS to use the latest OMB
delineations available to maintain a more accurate and up-to-date
payment system that reflects the reality of population shifts and labor
market conditions. While CMS and other stakeholders have explored
potential alternatives to the current CBSA-based labor market system
(we refer readers to the CMS Web site at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Wage-Index-Reform.html), no
consensus has been achieved regarding how best to implement a
replacement system. As discussed in the FY 2005 IPPS final rule (69 FR
49027), ``While we recognize that MSAs are not designed specifically to
define labor market areas, we believe they do represent a useful proxy
for this purpose.'' We further believe that using the most current OMB
delineations would increase the integrity of the HH PPS wage index by
creating a more accurate representation of geographic variation in wage
levels. We have reviewed our findings and impacts relating to the new
OMB delineations, and have concluded that there is no compelling reason
to further delay implementation.
We propose incorporating the new CBSA delineations into the CY 2015
HH PPS wage index in the same manner in which the CBSAs were first
incorporated into the HH PPS wage index in CY 2006 (70 FR 68138). We
propose to use a one-year blended wage index for CY 2015. We refer to
this blended wage index as the CY 2015 HH PPS transition wage index.
The transition wage index would consist of a 50/50 blend of the wage
index values using OMB's old area delineations and the wage index
values using OMB's new area delineations. That is, for each county, a
blended wage index would be calculated equal to fifty percent of the CY
2015 wage index using the old labor market area delineation and fifty
percent of the CY 2015 wage index using the new labor market area
delineation (both using FY 2011 hospital wage data). This ultimately
results in an average of the two values.
If we adopt the new OMB delineations, a total of 37 counties (and
county equivalents) that are currently considered part of an urban CBSA
would be considered rural beginning in CY 2015. Table 13 below lists
the 37 urban counties that would change to rural status.

Table 13--Counties That Would Change to Rural Status
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBSA No. under
County State CY 2014 HH PPS CBSA Name
--------------------------------------------------------------------------------------------------------------------------------------------------------
Greene County.......................... IN 14020 Bloomington, IN.
Anson County........................... NC 16740 Charlotte-Gastonia-Rock Hill, NC-SC.
Franklin County........................ IN 17140 Cincinnati-Middletown, OH-KY-IN.
Stewart County......................... TN 17300 Clarksville, TN-KY.
Howard County.......................... MO 17860 Columbia, MO.
Delta County........................... TX 19124 Dallas-Fort Worth-Arlington, TX.
Pittsylvania County.................... VA 19260 Danville, VA.
Danville City.......................... VA 19260 Danville, VA.
Preble County.......................... OH 19380 Dayton, OH.
Gibson County.......................... IN 21780 Evansville, IN-KY.
Webster County......................... KY 21780 Evansville, IN-KY.
Franklin County........................ AR 22900 Fort Smith, AR-OK.
Ionia County........................... MI 24340 Grand Rapids-Wyoming, MI.
Newaygo County......................... MI 24340 Grand Rapids-Wyoming, MI.
Greene County.......................... NC 24780 Greenville, NC.
Stone County........................... MS 25060 Gulfport-Biloxi, MS.
Morgan County.......................... WV 25180 Hagerstown-Martinsburg, MD-WV.
San Jacinto County..................... TX 26420 Houston-Sugar Land-Baytown, TX.
Franklin County........................ KS 28140 Kansas City, MO-KS.
Tipton County.......................... IN 29020 Kokomo, IN.
Nelson County.......................... KY 31140 Louisville/Jefferson County, KY-IN.
Geary County........................... KS 31740 Manhattan, KS.

[[Page 38393]]

Washington County...................... OH 37620 Parkersburg-Marietta-Vienna, WV-OH.
Pleasants County....................... WV 37620 Parkersburg-Marietta-Vienna, WV-OH.
George County.......................... MS 37700 Pascagoula, MS.
Power County........................... ID 38540 Pocatello, ID.
Cumberland County...................... VA 40060 Richmond, VA.
King and Queen County.................. VA 40060 Richmond, VA.
Louisa County.......................... VA 40060 Richmond, VA.
Washington County...................... MO 41180 St. Louis, MO-IL.
Summit County.......................... UT 41620 Salt Lake City, UT.
Erie County............................ OH 41780 Sandusky, OH.
Franklin County........................ MA 44140 Springfield, MA.
Ottawa County.......................... OH 45780 Toledo, OH.
Greene County.......................... AL 46220 Tuscaloosa, AL.
Calhoun County......................... TX 47020 Victoria, TX.
Surry County........................... VA 47260 Virginia Beach-Norfolk-Newport News, VA-NC.
--------------------------------------------------------------------------------------------------------------------------------------------------------

If we finalize our proposal to implement the new OMB delineations,
a total of 105 counties (and county equivalents) that are currently
located in rural areas would be considered part of an urban CBSA
beginning in CY 2015. Table 14 lists the 105 rural counties that would
change to urban status.

Table 14--Counties That Would Change to Urban Status
--------------------------------------------------------------------------------------------------------------------------------------------------------
County State CBSA No. CBSA Name
--------------------------------------------------------------------------------------------------------------------------------------------------------
Utuado Municipio....................... PR 10380 Aguadilla-Isabela, PR.
Linn County............................ OR 10540 Albany, OR.
Oldham County.......................... TX 11100 Amarillo, TX.
Morgan County.......................... GA 12060 Atlanta-Sandy Springs-Roswell, GA.
Lincoln County......................... GA 12260 Augusta-Richmond County, GA-SC.
Newton County.......................... TX 13140 Beaumont-Port Arthur, TX.
Fayette County......................... WV 13220 Beckley, WV.
Raleigh County......................... WV 13220 Beckley, WV.
Golden Valley County................... MT 13740 Billings, MT.
Oliver County.......................... ND 13900 Bismarck, ND.
Sioux County........................... ND 13900 Bismarck, ND.
Floyd County........................... VI 13980 Blacksburg-Christiansburg-Radford, VA.
De Witt County......................... IL 14010 Bloomington, IL.
Columbia County........................ PA 14100 Bloomsburg-Berwick, PA.
Montour County......................... PA 14100 Bloomsburg-Berwick, PA.
Allen County........................... KY 14540 Bowling Green, KY.
Butler County.......................... KY 14540 Bowling Green, KY.
St. Mary's County...................... MD 15680 California-Lexington Park, MD.
Jackson County......................... IL 16060 Carbondale-Marion, IL.
Williamson County...................... IL 16060 Carbondale-Marion, IL.
Franklin County........................ PA 16540 Chambersburg-Waynesboro, PA.
Iredell County......................... NC 16740 Charlotte-Concord-Gastonia, NC-SC.
Lincoln County......................... NC 16740 Charlotte-Concord-Gastonia, NC-SC.
Rowan County........................... NC 16740 Charlotte-Concord-Gastonia, NC-SC.
Chester County......................... SC 16740 Charlotte-Concord-Gastonia, NC-SC.
Lancaster County....................... SC 16740 Charlotte-Concord-Gastonia, NC-SC.
Buckingham County...................... VA 16820 Charlottesville, VA.
Union County........................... IN 17140 Cincinnati, OH-KY-IN.
Hocking County......................... OH 18140 Columbus, OH.
Perry County........................... OH 18140 Columbus, OH.
Walton County.......................... FL 18880 Crestview-Fort Walton Beach-Destin, FL.
Hood County............................ TX 23104 Dallas-Fort Worth-Arlington, TX.
Somervell County....................... TX 23104 Dallas-Fort Worth-Arlington, TX.
Baldwin County......................... AL 19300 Daphne-Fairhope-Foley, AL.
Monroe County.......................... PA 20700 East Stroudsburg, PA.
Hudspeth County........................ TX 21340 El Paso, TX.
Adams County........................... PA 23900 Gettysburg, PA.
Hall County............................ NE 24260 Grand Island, NE.
Hamilton County........................ NE 24260 Grand Island, NE.
Howard County.......................... NE 24260 Grand Island, NE.
Merrick County......................... NE 24260 Grand Island, NE.
Montcalm County........................ MI 24340 Grand Rapids-Wyoming, MI.
Josephine County....................... OR 24420 Grants Pass, OR.
Tangipahoa Parish...................... LA 25220 Hammond, LA.

[[Page 38394]]

Beaufort County........................ SC 25940 Hilton Head Island-Bluffton-Beaufort, SC.
Jasper County.......................... SC 25940 Hilton Head Island-Bluffton-Beaufort, SC.
Citrus County.......................... FL 26140 Homosassa Springs, FL.
Butte County........................... ID 26820 Idaho Falls, ID.
Yazoo County........................... MS 27140 Jackson, MS.
Crockett County........................ TN 27180 Jackson, TN.
Kalawao County......................... HI 27980 Kahului-Wailuku-Lahaina, HI.
Maui County............................ HI 27980 Kahului-Wailuku-Lahaina, HI.
Campbell County........................ TN 28940 Knoxville, TN.
Morgan County.......................... TN 28940 Knoxville, TN.
Roane County........................... TN 28940 Knoxville, TN.
Acadia Parish.......................... LA 29180 Lafayette, LA.
Iberia Parish.......................... LA 29180 Lafayette, LA.
Vermilion Parish....................... LA 29180 Lafayette, LA.
Cotton County.......................... OK 30020 Lawton, OK.
Scott County........................... IN 31140 Louisville/Jefferson County, KY-IN.
Lynn County............................ TX 31180 Lubbock, TX.
Green County........................... WI 31540 Madison, WI.
Benton County.......................... MS 32820 Memphis, TN-MS-AR.
Midland County......................... MI 33220 Midland, MI.
Martin County.......................... TX 33260 Midland, TX.
Le Sueur County........................ MN 33460 Minneapolis-St. Paul-Bloomington, MN-WI.
Mille Lacs County...................... MN 33460 Minneapolis-St. Paul-Bloomington, MN-WI.
Sibley County.......................... MN 33460 Minneapolis-St. Paul-Bloomington, MN-WI.
Maury County........................... TN 34980 Nashville-Davidson-Murfreesboro-Franklin, TN.
Craven County.......................... NC 35100 New Bern, NC.
Jones County........................... NC 35100 New Bern, NC.
Pamlico County......................... NC 35100 New Bern, NC.
St. James Parish....................... LA 35380 New Orleans-Metairie, LA.
Box Elder County....................... UT 36260 Ogden-Clearfield, UT.
Gulf County............................ FL 37460 Panama City, FL.
Custer County.......................... SD 39660 Rapid City, SD.
Fillmore County........................ MN 40340 Rochester, MN.
Yates County........................... NY 40380 Rochester, NY.
Sussex County.......................... DE 41540 Salisbury, MD-DE.
Worcester County....................... MA 41540 Salisbury, MD-DE.
Highlands County....................... FL 42700 Sebring, FL.
Webster Parish......................... LA 43340 Shreveport-Bossier City, LA.
Cochise County......................... AZ 43420 Sierra Vista-Douglas, AZ.
Plymouth County........................ IA 43580 Sioux City, IA-NE-SD.
Union County........................... SC 43900 Spartanburg, SC.
Pend Oreille County.................... WA 44060 Spokane-Spokane Valley, WA.
Stevens County......................... WA 44060 Spokane-Spokane Valley, WA.
Augusta County......................... VA 44420 Staunton-Waynesboro, VA.
Staunton City.......................... VA 44420 Staunton-Waynesboro, VA.
Waynesboro City........................ VA 44420 Staunton-Waynesboro, VA.
Little River County.................... AR 45500 Texarkana, TX-AR.
Sumter County.......................... FL 45540 The Villages, FL.
Pickens County......................... AL 46220 Tuscaloosa, AL.
Gates County........................... NC 47260 Virginia Beach-Norfolk-Newport News, VA-NC.
Falls County........................... TX 47380 Waco, TX.
Columbia County........................ WA 47460 Walla Walla, WA.
Walla Walla County..................... WA 47460 Walla Walla, WA.
Peach County........................... GA 47580 Warner Robins, GA.
Pulaski County......................... GA 47580 Warner Robins, GA.
Culpeper County........................ VA 47894 Washington-Arlington-Alexandria, DC-VA-MD-WV.
Rappahannock County.................... VA 47894 Washington-Arlington-Alexandria, DC-VA-MD-WV.
Jefferson County....................... NY 48060 Watertown-Fort Drum, NY.
Kingman County......................... KS 48620 Wichita, KS.
Davidson County........................ NC 49180 Winston-Salem, NC.
Windham County......................... CT 49340 Worcester, MA-CT.
--------------------------------------------------------------------------------------------------------------------------------------------------------

In addition to rural counties becoming urban and urban counties
becoming rural, several urban counties would shift from one urban CBSA
to another urban CBSA under our proposal to adopt the new OMB
delineations. In other cases, applying the new OMB delineations would
involve a change only in CBSA name or number, while the CBSA continues
to encompass the same constituent counties. For example, CBSA 29140
(Lafayette, IN), would experience both a change to its number and its
name, and would become CBSA 29200 (Lafayette-West Lafayette, IN), while
all of its three constituent counties would remain the same. We are not
discussing these proposed changes in this section because they are
inconsequential changes with respect to the HH PPS wage index. However,
in

[[Page 38395]]

other cases, if we adopt the new OMB delineations, counties would shift
between existing and new CBSAs, changing the constituent makeup of the
CBSAs.
In one type of change, an entire CBSA would be subsumed by another
CBSA. For example, CBSA 37380 (Palm Coast, FL) currently is a single
county (Flagler, FL) CBSA. Flagler County would be a part of CBSA 19660
(Deltona-Daytona Beach-Ormond Beach, FL) under the new OMB
delineations.
In another type of change, some CBSAs have counties that would
split off to become part of or to form entirely new labor market areas.
For example, CBSA 37964 (Philadelphia Metropolitan Division of MSA
37980) currently is comprised of five Pennsylvania counties (Bucks,
Chester, Delaware, Montgomery, and Philadelphia). If we adopt the new
OMB delineations, Montgomery, Bucks, and Chester counties would split
off and form the new CBSA 33874 (Montgomery County-Bucks County-Chester
County, PA Metropolitan Division of MSA 37980), while Delaware and
Philadelphia counties would remain in CBSA 37964.
Finally, in some cases, a CBSA would lose counties to another
existing CBSA if we adopt the new OMB delineations. For example,
Lincoln County and Putnam County, WV would move from CBSA 16620
(Charleston, WV) to CBSA 26580 (Huntington-Ashland, WV KY OH). CBSA
16620 would still exist in the new labor market delineations with fewer
constituent counties. Table 15 lists the urban counties that would move
from one urban CBSA to another urban CBSA if we adopt the new OMB
delineations.

Table 15--Counties That Would Change to a Different CBSA
------------------------------------------------------------------------
Previous CBSA New CBSA County State
------------------------------------------------------------------------
11300........................ 26900 Madison County. IN
11340........................ 24860 Anderson County SC
14060........................ 14010 McLean County.. IL
37764........................ 15764 Essex County... MA
16620........................ 26580 Lincoln County. WV
16620........................ 26580 Putnam County.. WV
16974........................ 20994 DeKalb County.. IL
16974........................ 20994 Kane County.... IL
21940........................ 41980 Ceiba Municipio PR
21940........................ 41980 Fajardo PR
Municipio.
21940........................ 41980 Luquillo PR
Municipio.
26100........................ 24340 Ottawa County.. MI
31140........................ 21060 Meade County... KY
34100........................ 28940 Grainger County TN
35644........................ 35614 Bergen County.. NJ
35644........................ 35614 Hudson County.. NJ
20764........................ 35614 Middlesex NJ
County.
20764........................ 35614 Monmouth County NJ
20764........................ 35614 Ocean County... NJ
35644........................ 35614 Passaic County. NJ
20764........................ 35084 Somerset County NJ
35644........................ 35614 Bronx County... NY
35644........................ 35614 Kings County... NY
35644........................ 35614 New York County NY
35644........................ 20524 Putnam County.. NY
35644........................ 35614 Queens County.. NY
35644........................ 35614 Richmond County NY
35644........................ 35614 Rockland County NY
35644........................ 35614 Westchester NY
County.
37380........................ 19660 Flagler County. FL
37700........................ 25060 Jackson County. MS
37964........................ 33874 Bucks County... PA
37964........................ 33874 Chester County. PA
37964........................ 33874 Montgomery PA
County.
39100........................ 20524 Dutchess County NY
39100........................ 35614 Orange County.. NY
41884........................ 42034 Marin County... CA
41980........................ 11640 Arecibo PR
Municipio.
41980........................ 11640 Camuy Municipio PR
41980........................ 11640 Hatillo PR
Municipio.
41980........................ 11640 Quebradillas PR
Municipio.
48900........................ 34820 Brunswick NC
County.
49500........................ 38660 Gu[aacute]nica PR
Municipio.
49500........................ 38660 Guayanilla PR
Municipio.
49500........................ 38660 Pe[ntilde]uelas PR
Municipio.
49500........................ 38660 Yauco Municipio PR
------------------------------------------------------------------------

As discussed in the FY 2015 SNF PPS proposed rule (79 FR 25767), we
proposed to adopt OMB's new delineations in the SNF PPS in the same
manner that we are proposing to adopt the new delineations in the HH
PPS. The FY 2015 SNF PPS proposed rule includes extensive analysis of
the application of OMB's new delineations as well as other alternatives
considered.
For the reasons discussed above, and based on provider reaction
during the CY 2006 rulemaking cycle to the proposed adoption of the new
CBSA definitions, we are proposing to apply a

[[Page 38396]]

one-year blended wage index in CY 2015 for all geographic areas to
assist providers in adapting to these proposed changes. This transition
policy would be for a one-year period, going into effect January 1,
2015, and continuing through December 31, 2015. Thus, beginning January
1, 2016, the wage index for all HH PPS payments would be fully based on
the new OMB delineations. We invite comments on our proposed transition
methodology, as well as on the other transition options discussed
above.
The wage index Addendum provides a crosswalk between the CY 2015
wage index using the current OMB delineations in effect in CY 2014 and
the CY 2015 wage index using the revised OMB delineations. Addendum A
shows each state and county and its corresponding proposed transition
wage index along with the previous CBSA number, the new CBSA number and
the new CBSA name. Due to the calculation of the blended transition
wage index, some CBSAs may have more than one transition wage index
value associated with that CBSA. However, each county will have only
one transition wage index. Therefore, for counties located in CBSAs
that correspond to more than one transition wage index, a number other
than the CBSA number would be used for claims submission for CY 2015
only. These numbers are shown in the last column of Addendum A. The
proposed CY 2015 transition wage index as set forth in Addendum A is
available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html.
5. Proposed CY 2015 Annual Payment Update
a. Background
The Medicare HH PPS has been in effect since October 1, 2000. As
set forth in the July 3, 2000 final rule (65 FR 41128), the base unit
of payment under the Medicare HH PPS is a national, standardized 60-day
episode payment rate. As set forth in 42 CFR 484.220, we adjust the
national, standardized 60-day episode payment rate by a case-mix
relative weight and a wage index value based on the site of service for
the beneficiary.
To provide appropriate adjustments to the proportion of the payment
amount under the HH PPS to account for area wage differences, we apply
the appropriate wage index value to the labor portion of the HH PPS
rates. The labor-related share of the case-mix adjusted 60-day episode
rate will continue to be 78.535 percent and the non-labor-related share
will continue to be 21.465 percent as set out in the CY 2013 HH PPS
final rule (77 FR 67068). The CY 2015 HH PPS rates would use the same
case-mix methodology as set forth in the CY 2008 HH PPS final rule with
comment period (72 FR 49762) and adjusted as described in section
III.C. of this rule. The following are the steps we take to compute the
case-mix and wage-adjusted 60-day episode rate:
(1) Multiply the national 60-day episode rate by the patient's
applicable case-mix weight.
(2) Divide the case-mix adjusted amount into a labor (78.535
percent) and a non-labor portion (21.465 percent).
(3) Multiply the labor portion by the applicable wage index based
on the site of service of the beneficiary.
(4) Add the wage-adjusted portion to the non-labor portion,
yielding the case-mix and wage adjusted 60-day episode rate, subject to
any additional applicable adjustments.
In accordance with section 1895(b)(3)(B) of the Act, this document
constitutes the annual update of the HH PPS rates. Section 484.225 sets
forth the specific annual percentage update methodology. In accordance
with Sec. 484.225(i), for a HHA that does not submit HH quality data,
as specified by the Secretary, the unadjusted national prospective 60-
day episode rate is equal to the rate for the previous calendar year
increased by the applicable HH market basket index amount minus two
percentage points. Any reduction of the percentage change will apply
only to the calendar year involved and will not be considered in
computing the prospective payment amount for a subsequent calendar
year.
Medicare pays the national, standardized 60-day case-mix and wage-
adjusted episode payment on a split percentage payment approach. The
split percentage payment approach includes an initial percentage
payment and a final percentage payment as set forth in Sec.
484.205(b)(1) and Sec. 484.205(b)(2). We may base the initial
percentage payment on the submission of a request for anticipated
payment (RAP) and the final percentage payment on the submission of the
claim for the episode, as discussed in Sec. 409.43. The claim for the
episode that the HHA submits for the final percentage payment
determines the total payment amount for the episode and whether we make
an applicable adjustment to the 60-day case-mix and wage-adjusted
episode payment. The end date of the 60-day episode as reported on the
claim determines which calendar year rates Medicare will use to pay the
claim.
We may also adjust the 60-day case-mix and wage-adjusted episode
payment based on the information submitted on the claim to reflect the
following:
A low-utilization payment adjustment (LUPA) is provided on
a per-visit basis as set forth in Sec. 484.205(c) and Sec. 484.230.
A partial episode payment (PEP) adjustment as set forth in
Sec. 484.205(d) and Sec. 484.235.
An outlier payment as set forth in Sec. 484.205(e) and
Sec. 484.240.
b. Proposed CY 2015 National, Standardized 60-Day Episode Payment Rate
Section 1895(3)(A)(i) of the Act required that the 60-day episode
base rate and other applicable amounts be standardized in a manner that
eliminates the effects of variations in relative case mix and area wage
adjustments among different home health agencies in a budget neutral
manner. To determine the proposed CY 2015 national, standardized 60-day
episode payment rate, we would apply a wage index standardization
factor, a case-mix budget neutrality factor described in section III.C,
the rebasing adjustment described in section II.C, and the MFP-adjusted
home health market basket update discussed in section III.D.1 of this
proposed rule.
To calculate the wage index standardization factor, henceforth
referred to as the wage index budget neutrality factor, we simulated
total payments for non-LUPA episodes using the 2015 wage index and
compared it to our simulation of total payments for non-LUPA episodes
using the 2014 wage index. By dividing the total payments for non-LUPA
episodes using the 2015 wage index by the total payments for non-LUPA
episodes using the 2014 wage index, we obtain a wage index budget
neutrality factor of 1.0012. We would apply the wage index budget
neutrality factor of 1.0012 to the CY 2015 national, standardized 60-
day episode rate.
As discussed in section III.C of this proposed rule, to ensure the
changes to the case-mix weights are implemented in a budget neutral
manner, we would apply a case-mix weights budget neutrality factor to
the CY 2015 national, standardized 60-day episode payment rate. The
case-mix weights budget neutrality factor is calculated as the ratio of
total payments when CY 2015 case-mix weights are applied to CY 2013
utilization (claims) data to total payments when CY 2014 case-mix

[[Page 38397]]

weights are applied to CY 2013 utilization data. The case-mix budget
neutrality factor for CY 2015 would be 1.0237 as proposed in section
III.C of this proposed rule.
Then, we would apply the -$80.95 rebasing adjustment finalized in
the CY 2014 HH PPS final rule (78 FR 72256) and discussed in section
II.C. Lastly, we would update the payment rates by the CY 2015 HH
payment update percentage of 2.2 percent (MFP-adjusted home health
market basket update) as described in section III.D.1 of this proposed
rule. The proposed CY 2015 national, standardized 60-day episode
payment rate would be $2,922.76 as calculated in Table 16.

Table 16--CY 2015 60-Day National, Standardized 60-Day Episode Payment Amount
--------------------------------------------------------------------------------------------------------------------------------------------------------
CY 2014 national, Proposed CY 2015
standardized 60-day Wage index budget Case-mix weights budget CY 2015 Rebasing CY 2015 HH payment national, standardized
episode payment neutrality factor neutrality factor adjustment update percentage 60-day episode payment
--------------------------------------------------------------------------------------------------------------------------------------------------------
$2,869.27 x 1.0012 x 1.0237 - $80.95 x 1.022 = $2,922.76
--------------------------------------------------------------------------------------------------------------------------------------------------------

The proposed CY 2015 national, standardized 60-day episode payment
rate for an HHA that does not submit the required quality data is
updated by the CY 2015 HH payment update percentage (2.2 percent) minus
2 percentage points and is shown in Table 17.

Table 17--For HHAs That Do Not Submit the Quality Data--Proposed CY 2015 National, Standardized 60-Day Episode Payment Amount
--------------------------------------------------------------------------------------------------------------------------------------------------------
CY 2014 National, CY 2015 HH Payment Proposed CY 2015
standardized 60-day Wage index budget Case-mix weights budget CY 2015 Rebasing update percentage minus national, standardized
episode payment neutrality factor neutrality factor adjustment 2 percentage points 60-day episode payment
--------------------------------------------------------------------------------------------------------------------------------------------------------
$2,869.27 x 1.0012 x 1.0237 - $80.95 x 1.002 = $2,865.57
--------------------------------------------------------------------------------------------------------------------------------------------------------

c. Proposed National Per-Visit Rates
The national per-visit rates are used to pay LUPAs (episodes with
four or fewer visits) and are also used to compute imputed costs in
outlier calculations. The per-visit rates are paid by type of visit or
HH discipline. The six HH disciplines are as follows:
Home health aide (HH aide);
Medical Social Services (MSS);
Occupational therapy (OT);
Physical therapy (PT);
Skilled nursing (SN); and
Speech-language pathology (SLP).
To calculate the CY 2015 national per-visit rates, we start with
the CY 2014 national per-visit rates. We then apply a wage index budget
neutrality factor to ensure budget neutrality for LUPA per-visit
payments and increase each of the six per-visit rates by the maximum
rebasing adjustments described in section II.C. of this rule. We
calculate the wage index budget neutrality factor by simulating total
payments for LUPA episodes using the 2015 wage index and comparing it
to simulated total payments for LUPA episodes using the 2014 wage
index. By dividing the total payments for LUPA episodes using the 2015
wage index by the total payments for LUPA episodes using the 2014 wage
index, we obtain a wage index budget neutrality factor of 1.0000. We
would apply the wage index budget neutrality factor of 1.0000 to the CY
2015 national per-visit rates.
The LUPA per-visit rates are not calculated using case-mix weights.
Therefore, there is no case-mix weights budget neutrality factor is
needed to ensure budget neutrality for LUPA payments. Finally, the per-
visit rates for each discipline are updated by the CY 2015 HH payment
update percentage of 2.2 percent. The national per-visit rates are
adjusted by the wage index based on the site of service of the
beneficiary. The per-visit payments for LUPAs are separate from the
LUPA add-on payment amount, which is paid for episodes that occur as
the only episode or initial episode in a sequence of adjacent episodes.
The proposed CY 2015 national per-visit rates are shown in Tables 18
and 19.

Table 18--Proposed CY 2015 National Per-Visit Payment Amounts for HHAs That DO Submit the Required Quality Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
CY 2015 HH
HH Discipline type CY 2014 Per-visit Wage index budget CY 2015 Rebasing Payment update Proposed CY 2015
payment neutrality factor adjustment percentage per-visit payment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home Health Aide......................................... $54.84 x 1.0000 + $1.79 x 1.022 $57.88
Medical Social Services.................................. $194.12 x 1.0000 + $6.34 x 1.022 $204.87
Occupational Therapy..................................... $133.30 x 1.0000 + $4.35 x 1.022 $140.68
Physical Therapy......................................... $132.40 x 1.0000 + $4.32 x 1.022 $139.73
Skilled Nursing.......................................... $121.10 x 1.0000 + $3.96 x 1.022 $127.81
Speech-Language Pathology................................ $143.88 x 1.0000 + 4.70 x 1.022 $151.85
--------------------------------------------------------------------------------------------------------------------------------------------------------

The proposed CY 2015 per-visit payment rates for an HHA that does
not submit the required quality data are updated by the CY 2015 HH
payment update percentage (2.2 percent) minus 2

[[Page 38398]]

percentage points and is shown in Table 19.

Table 19--Proposed CY 2015 National Per-Visit Payment Amounts for HHAs That DO NOT Submit the Required Quality Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
CY 2015 HH
Payment update
HH Discipline Type CY 2014 Per-visit Wage index budget CY 2015 Rebasing percentage minus Proposed CY 2015
rates neutrality factor adjustment 2 percentage per-visit rates
points
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home Health Aide......................................... $54.84 x 1.0000 + $1.79 x 1.002 $56.74
Medical Social Services.................................. $194.12 x 1.0000 + $6.34 x 1.002 $200.86
Occupational Therapy..................................... $133.30 x 1.0000 + $4.35 x 1.002 $137.93
Physical Therapy......................................... $132.40 x 1.0000 + $4.32 x 1.002 $136.99
Skilled Nursing.......................................... $121.10 x 1.0000 + $3.96 x 1.002 $125.31
Speech-Language Pathology................................ $143.88 x 1.0000 + 4.70 x 1.002 $148.88
--------------------------------------------------------------------------------------------------------------------------------------------------------

d. Low-Utilization Payment Adjustment (LUPA) Add-On Factors
LUPA episodes that occur as the only episode or as an initial
episode in a sequence of adjacent episodes are adjusted by applying an
additional amount to the LUPA payment before adjusting for area wage
differences. In the CY 2014 HH PPS final rule, we changed the
methodology for calculating the LUPA add-on amount by finalizing the
use of three LUPA add-on factors: 1.8451 for SN; 1.6700 for PT; and
1.6266 for SLP (78 FR 72306). We multiply the per-visit payment amount
for the first SN, PT, or SLP visit in LUPA episodes that occur as the
only episode or an initial episode in a sequence of adjacent episodes
by the appropriate factor to determine the LUPA add-on payment amount.
For example, for LUPA episodes that occur as the only episode or an
initial episode in a sequence of adjacent episodes, if the first
skilled visit is SN, the payment for that visit will be $235.82 (1.8451
multiplied by $127.81).
e. Proposed Non-Routine Medical Supply (NRS) Conversion Factor Update
Payments for NRS are computed by multiplying the relative weight
for a particular severity level by the NRS conversion factor. To
determine the CY 2015 NRS conversion factor, we start with the 2014 NRS
conversion factor ($53.65) and apply the -2.82 percent rebasing
adjustment calculated in section II.C. of this rule (1 - 0.0282 =
0.9718). We then update the conversion factor by the CY 2015 HH payment
update percentage (2.2 percent). We do not apply a standardization
factor as the NRS payment amount calculated from the conversion factor
is not wage or case-mix adjusted when the final claim payment amount is
computed. The proposed NRS conversion factor for CY 2015 is shown in
Table 20.

Table 20--Proposed CY 2015 NRS Conversion Factor for HHAs That DO Submit the Required Quality Data
----------------------------------------------------------------------------------------------------------------
Proposed CY
CY 2015 CY 2015 HH 2015 NRS
CY 2014 NRS conversion factor Rebasing Payment update conversion
adjustment percentage factor
----------------------------------------------------------------------------------------------------------------
$53.65....................................................... x 0.9718 x 1.022 = $53.28
----------------------------------------------------------------------------------------------------------------

Using the proposed CY 2015 NRS conversion factor, the proposed
payment amounts for the six severity levels are shown in Table 21.

Table 21--Proposed CY 2015 NRS Payment Amounts for HHAs That DO Submit the Required Quality Data
----------------------------------------------------------------------------------------------------------------
Proposed CY 2015
Severity level Points (scoring) Relative weight NRS payment
amounts
----------------------------------------------------------------------------------------------------------------
1.......................................... 0............................ 0.2698 $14.37
2.......................................... 1 to 14...................... 0.9742 51.91
3.......................................... 15 to 27..................... 2.6712 142.32
4.......................................... 28 to 48..................... 3.9686 211.45
5.......................................... 49 to 98..................... 6.1198 326.06
6.......................................... 99+.......................... 10.5254 560.79
----------------------------------------------------------------------------------------------------------------

For HHAs that do not submit the required quality data, we again
begin with the CY 2014 NRS conversion factor ($53.65) and apply the -
2.82 percent rebasing adjustment discussed in section II.C of this
proposed rule (1- 0.0282 = 0.9718). We then update the NRS conversion
factor by the CY 2015 HH payment update percentage (2.2 percent) minus
2 percentage points. The proposed CY 2015 NRS conversion factor for
HHAs that do not submit quality data is shown in Table 22.

[[Page 38399]]

Table 22--Proposed CY 2015 NRS Conversion Factor for HHAs That DO NOT Submit the Required Quality Data
----------------------------------------------------------------------------------------------------------------
CY 2015 HH Payment
CY 2015 Rebasing update percentage Proposed CY 2015
CY 2014 NRS conversion factor adjustment minus 2 percentage NRS conversion
points factor
----------------------------------------------------------------------------------------------------------------
$53.65.............................................. x 0.9718 x 1.002 $52.24
----------------------------------------------------------------------------------------------------------------

The proposed payment amounts for the various severity levels based
on the updated conversion factor for HHAs that do not submit quality
data are calculated in Table 23.

Table 23--Proposed CY 2015 NRS Payment Amounts for HHAs That DO NOT Submit the Required Quality Data
----------------------------------------------------------------------------------------------------------------
Proposed CY 2015
Severity level Points (scoring) Relative weight NRS payment
amounts
----------------------------------------------------------------------------------------------------------------
1.......................................... 0............................ 0.2698 $14.09
2.......................................... 1 to 14...................... 0.9742 50.89
3.......................................... 15 to 27..................... 2.6712 139.54
4.......................................... 28 to 48..................... 3.9686 207.32
5.......................................... 49 to 98..................... 6.1198 319.70
6.......................................... 99+.......................... 10.5254 549.85
----------------------------------------------------------------------------------------------------------------

f. Rural Add-On
Section 421(a) of the MMA required, for HH services furnished in a
rural areas (as defined in section 1886(d)(2)(D) of the Act), for
episodes or visits ending on or after April 1, 2004, and before April
1, 2005, that the Secretary increase the payment amount that otherwise
will have been made under section 1895 of the Act for the services by 5
percent.
Section 5201 of the DRA amended section 421(a) of the MMA. The
amended section 421(a) of the MMA required, for HH services furnished
in a rural area (as defined in section 1886(d)(2)(D) of the Act), on or
after January 1, 2006 and before January 1, 2007, that the Secretary
increase the payment amount otherwise made under section 1895 of the
Act for those services by 5 percent.
Section 3131(c) of the Affordable Care Act amended section 421(a)
of the MMA to provide an increase of 3 percent of the payment amount
otherwise made under section 1895 of the Act for HH services furnished
in a rural area (as defined in section 1886(d)(2)(D) of the Act), for
episodes and visits ending on or after April 1, 2010, and before
January 1, 2016.
Section 421 of the MMA, as amended, waives budget neutrality
related to this provision, as the statute specifically states that the
Secretary shall not reduce the standard prospective payment amount (or
amounts) under section 1895 of the Act applicable to HH services
furnished during a period to offset the increase in payments resulting
in the application of this section of the statute.
Refer to Tables 24 through 27 for the proposed payment rates for
home health services provided in rural areas.

Table 24--Proposed CY 2015 Payment Amounts for 60-Day Episodes for Services Provided in a Rural Area
--------------------------------------------------------------------------------------------------------------------------------------------------------
For HHAs that DO submit quality data For HHAs that DO NOT submit quality data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed CY 2015 Proposed CY 2015
Multiply by rural national, CY 2015 national, Multiply by rural national,
CY 2015 national, standardized 60-day episode payment rate the 3 standardized 60- standardized 60- the 3 standardized 60-
percent day episode day episode percent day episode
rural add-on payment rate payment rate rural add-on payment rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
$2,922.76....................................................... x 1.03 $3,010.44 $2,865.57 x 1.03 $2,951.54
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 25--Proposed CY 2015 Per-Visit Amounts for Services Provided in a Rural Area
----------------------------------------------------------------------------------------------------------------
For HHAs that DO submit quality data For HHAs that DO NOT submit quality
-------------------------------------------------------------------------- data
--------------------------------------
Multiply by Proposed CY Multiply by
CY 2015 per- the 3 2015 rural the 3 Proposed CY
HH discipline type visit rate percent per-visit CY 2015 per- percent 2015 rural
rural add- rates visit rate rural add- per-visit
on on rates
----------------------------------------------------------------------------------------------------------------
HH Aide $57.88 x 1.03 $59.62 $56.74 x 1.03 $58.44
MSS 204.87 x 1.03 211.02 200.86 x 1.03 206.89
OT 140.68 x 1.03 144.90 137.93 x 1.03 142.07
PT 139.73 x 1.03 143.92 136.99 x 1.03 141.10
SN 127.81 x 1.03 131.64 125.31 x 1.03 129.07

[[Page 38400]]

SLP 151.85 x 1.03 156.41 148.88 x 1.03 153.35
----------------------------------------------------------------------------------------------------------------

Table 26--Proposed CY 2015 NRS Conversion Factor for Services Provided in Rural Areas
--------------------------------------------------------------------------------------------------------------------------------------------------------
For HHAs that DO submit quality data For HHAs that DO NOT submit quality data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed CY Proposed CY
Multiply by the 2015 rural NRS CY 2015 Multiply by the 2015 rural NRS
CY 2015 conversion factor 3 percent rural conversion conversion 3 percent rural conversion
add-on factor factor add-on factor
--------------------------------------------------------------------------------------------------------------------------------------------------------
$53.28............................................................. x 1.03 $54.88 $52.24 x 1.03 $53.81
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 27--Proposed CY 2015 NRS Payment Amounts for Services Provided in Rural Areas
--------------------------------------------------------------------------------------------------------------------------------------------------------
For HHAs that DO submit quality data For HHAs that DO NOT submit quality data
(proposed CY 2015 NRS conversion factor = (proposed CY 2015 NRS conversion factor =
$54.88) $53.81)
Severity level Points (scoring) ---------------------------------------------------------------------------------------
Proposed CY 2015 NRS Proposed CY 2015 NRS
Relative weight payment amounts for Relative weight payment amounts for
rural areas rural areas
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..................................... 0....................... 0.2698 $14.81 0.2698 $14.52
2..................................... 1 to 14................. 0.9742 53.46 0.9742 52.42
3..................................... 15 to 27................ 2.6712 146.60 2.6712 143.74
4..................................... 28 to 48................ 3.9686 217.80 3.9686 213.55
5..................................... 49 to 98................ 6.1198 335.85 6.1198 329.31
6..................................... 99+..................... 10.5254 577.63 10.5254 566.37
--------------------------------------------------------------------------------------------------------------------------------------------------------

E. Payments for High-Cost Outliers Under the HH PPS

1. Background
Section 1895(b)(5) of the Act allows for the provision of an
addition or adjustment to the national, standardized 60-day case-mix
and wage-adjusted episode payment amounts in the case of episodes that
incur unusually high costs due to patient care needs. Prior to the
enactment of the Affordable Care Act, section 1895(b)(5) of the Act
stipulated that projected total outlier payments could not exceed 5
percent of total projected or estimated HH payments in a given year. In
the Medicare Program; Prospective Payment System for Home Health
Agencies final rule (65 FR 41188 through 41190), we described the
method for determining outlier payments. Under this system, outlier
payments are made for episodes whose estimated costs exceed a threshold
amount for each HH Resource Group (HHRG). The episode's estimated cost
is the sum of the national wage-adjusted per-visit payment amounts for
all visits delivered during the episode. The outlier threshold for each
case-mix group or PEP adjustment is defined as the 60-day episode
payment or PEP adjustment for that group plus a fixed-dollar loss (FDL)
amount. The outlier payment is defined to be a proportion of the wage-
adjusted estimated cost beyond the wage-adjusted threshold. The
threshold amount is the sum of the wage and case-mix adjusted PPS
episode amount and wage-adjusted FDL amount. The proportion of
additional costs over the outlier threshold amount paid as outlier
payments is referred to as the loss-sharing ratio.
In the CY 2010 HH PPS final rule (74 FR 58080 through 58087), we
discussed excessive growth in outlier payments, primarily the result of
unusually high outlier payments in a few areas of the country. Despite
program integrity efforts associated with excessive outlier payments in
targeted areas of the country, we discovered that outlier expenditures
still exceeded the 5 percent, target and, in the absence of corrective
measures, would continue do to so. Consequently, we assessed the
appropriateness of taking action to curb outlier abuse. To mitigate
possible billing vulnerabilities associated with excessive outlier
payments and adhere to our statutory limit on outlier payments, we
adopted an outlier policy that included a 10 percent agency-level cap
on outlier payments. This cap was implemented in concert with a reduced
FDL ratio of 0.67. These policies resulted in a projected target
outlier pool of approximately 2.5 percent. (The previous outlier pool
was 5 percent of total HH expenditure). For CY 2010, we first returned
5 percent of these dollars back into the national, standardized 60-day
episode rates, the national per-visit rates, the LUPA add-on payment
amount, and the NRS conversion factor. Then, we reduced the CY 2010
rates by 2.5 percent to account for the new outlier pool of 2.5
percent. This outlier policy was adopted for CY 2010 only.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through
70399), section 3131(b)(1) of the Affordable Care Act amended section
1895(b)(3)(C) of the Act. As amended, ``Adjustment for outliers,''
states that ``The Secretary shall reduce the standard prospective
payment amount (or amounts) under this paragraph applicable to HH
services furnished during a period by such proportion as will result in
an aggregate reduction in payments for the period equal to 5 percent of
the total payments estimated to be made based on the prospective
payment system under this subsection for the period.'' In addition,

[[Page 38401]]

section 3131(b)(2) of the Affordable Care Act amended section
1895(b)(5) of the Act by re-designating the existing language as
section 1895(b)(5)(A) of the Act, and revising it to state that the
Secretary, ``subject to [a 10 percent program-specific outlier cap],
may provide for an addition or adjustment to the payment amount
otherwise made in the case of outliers because of unusual variations in
the type or amount of medically necessary care. The total amount of the
additional payments or payment adjustments made under this paragraph
for a fiscal year or year may not exceed 2.5 percent of the total
payments projected or estimated to be made based on the prospective
payment system under this subsection in that year.''
As such, beginning in CY 2011, our HH PPS outlier policy is that we
reduce payment rates by 5 percent and target up to 2.5 percent of total
estimated HH PPS payments to be paid as outliers. To do so, we first
returned the 2.5 percent held for the target CY 2010 outlier pool to
the national, standardized 60-day episode rates, the national per visit
rates, the LUPA add-on payment amount, and the NRS conversion factor
for CY 2010. We then reduced the rates by 5 percent as required by
section 1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of
the Affordable Care Act. For CY 2011 and subsequent calendar years we
target up to 2.5 percent of estimated total payments to be paid as
outlier payments, and apply a 10 percent agency-level outlier cap.
2. Fixed Dollar Loss (FDL) Ratio and Loss-Sharing Ratio
For a given level of outlier payments, there is a trade-off between
the values selected for the FDL ratio and the loss-sharing ratio. A
high FDL ratio reduces the number of episodes that can receive outlier
payments, but makes it possible to select a higher loss-sharing ratio,
and therefore, increase outlier payments for outlier episodes.
Alternatively, a lower FDL ratio means that more episodes can qualify
for outlier payments, but outlier payments per episode must then be
lower.
The FDL ratio and the loss-sharing ratio must be selected so that
the estimated total outlier payments do not exceed the 2.5 percent
aggregate level (as required by section 1895(b)(5)(A) of the Act).
Historically, we have used a value of 0.80 for the loss-sharing ratio
which, we believe, preserves incentives for agencies to attempt to
provide care efficiently for outlier cases. With a loss-sharing ratio
of 0.80, Medicare pays 80 percent of the additional estimated costs
above the outlier threshold amount. We are not proposing a change to
the loss-sharing ratio in this proposed rule.
In the CY 2011 HH PPS final rule (75 FR 70398), in targeting total
outlier payments as 2.5 percent of total HH PPS payments, we
implemented an FDL ratio of 0.67, and we maintained that ratio in CY
2012. Simulations based on CY 2010 claims data completed for the CY
2013 HH PPS final rule showed that outlier payments were estimated to
comprise approximately 2.18 percent of total HH PPS payments in CY
2013, and as such, we lowered the FDL ratio from 0.67 to 0.45. We
stated that lowering the FDL ratio to 0.45, while maintaining a loss-
sharing ratio of 0.80, struck an effective balance of compensating for
high-cost episodes while allowing more episodes to qualify as outlier
payments (77 FR 67080). The national, standardized 60-day episode
payment amount is multiplied by the FDL ratio. That amount is wage-
adjusted to derive the wage-adjusted FDL amount, which is added to the
case-mix and wage-adjusted 60-day episode payment amount to determine
the outlier threshold amount that costs have to exceed before Medicare
will pay 80 percent of the additional estimated costs.
Based on simulations using preliminary CY 2013 claims data, the
proposed CY 2015 payments rates in section III.D.4 of this proposed
rule, and the FDL ratio of 0.45; we estimate that outlier payments
would comprise approximately 2.26 percent of total HH PPS payments in
CY 2015. Simulating payments using preliminary CY 2013 claims data and
the CY 2014 payment rates (78 FR 72304 through 72308), we estimate that
outlier payments would comprise 2.01 percent of total payments. Given
the proposed increases to the CY 2015 national per-visit payment rates,
our analysis estimates an additional 0.25 percentage point increase in
estimated outlier payments as a percent of total HH PPS payments each
year that we phase-in the rebasing adjustments described in section
II.C. We estimate that for CY 2016, estimated outlier payments as a
percent of total HH PPS payments will increase to 2.51 percent. We note
that these estimates do not take in to account any changes in
utilization that may have occurred in CY 2014, and would continue to
occur in CY 2015. Therefore, we are not proposing a change to the FDL
ratio for CY 2015. In the final rule, we will update our estimate of
outlier payments as a percent of total HH PPS payments using the most
current and complete year of HH PPS data. We will continue to monitor
the percent of total HH PPS payments paid as outlier payments to
determine if future adjustments to either the FDL ratio or loss-sharing
ratio are warranted.

F. Medicare Coverage of Insulin Injections Under the HH PPS

Home health policy regarding coverage of home health visits for the
sole purpose of insulin injections is limited to patients that are
physically or mentally unable to self-inject and there is no other
person who is able and willing to inject the patient.\16\ However, the
Office of Inspector General concluded in August 2013 that some
previously covered home health visits for the sole purpose of insulin
injections were unnecessary because the patient was physically and
mentally able to self-inject.\17\ In addition, results from analysis in
response to public comments on the CY 2014 HH PPS final rule found that
episodes that qualify for outlier payments in excess of $10,000 had, on
average, 160 skilled nursing visits in a 60-day episode of care with 95
percent of the episodes listing a primary diagnosis of diabetes or
long-term use of insulin (78 FR 72310). Therefore, we conducted a
literature review regarding generally accepted clinical management
practices for diabetic patients and conducted further analysis of home
health claims data to investigate the extent to which episodes with
visits likely for the sole purpose of insulin injections are in fact
limited to patients that are physically or mentally unable to self-
inject.
---------------------------------------------------------------------------

\16\ Medicare Coverage Benefit Policy Manual (Pub. 100-02),
Section 40.1.2.4.B.2 ``Insulin Injections''.
\17\ Levinson, Daniel R. Management Implication Report 12-0011,
Unnecessary Home Health Care for Diabetic Patients.
---------------------------------------------------------------------------

As generally accepted by the medical community, older patients (age
65 and older) are more likely to have impairments in dexterity,
cognition, vision, and hearing.\18\ While studies have shown that most
elderly patients starting or continuing on insulin can inject
themselves, these conditions may affect the elderly individual's
ability to self-inject insulin. It is clinically essential that there
is careful assessment prior to the initiation of home care, and
throughout the course of treatment, regarding the patient's capacity
for self-injection. There are multiple reliable, and validated
assessment tools that may be used to assess the elderly individual's
ability to self-inject. These tools assess the individual's ability to
perform activities of daily living (ADLs), as well as, cognitive,
functional, and

[[Page 38402]]

behavioral status.\19\ These assessment tools have also proved valid
for judging patients' ability to inject insulin independently and to
recognize and deal with hypoglycemia.\20\
---------------------------------------------------------------------------

\18\ Strategies for Insulin Injection Therapy in Diabetes Self-
Management. (2011). American Association of Diabetes Educators.
\19\ Hendra, T.J. Starting insulin therapy in elderly patients.
(2012). Journal of the Royal Society of Medicine. 95(9), 453-455.
\20\ Sinclair AJ, Turnbull CJ, Croxson SCM. Document of care for
older people with diabetes. Postgrad Med J 1996;72: 334-8.
---------------------------------------------------------------------------

Another important consideration with regards to insulin
administration in the elderly population is the possibility of dosing
errors.\21\ Correct administration and accurate dosing is important in
order to prevent serious complications, such as hypoglycemia and
hyperglycemia. The traditional vial and syringe method of insulin
administration involves several steps, including injecting air into the
vial, drawing an amount out of the vial into a syringe with small
measuring increments, and verifying the correct dose visually.\22\ In
some cases, an insulin pen can be used as an alternative to the
traditional vial and syringe method.
---------------------------------------------------------------------------

\21\ Coscelli C, Lostia S, Lunetta M, Nosari I, Coronel GA.
Safety, efficacy, acceptability of a pre-filled insulin pen in
diabetic patients over 60 years old. Diabetes Research and Clinical
Practice. 1995;38:173-7. [PubMed]
\22\ Flemming DR. Mightier than the syringe. Am J Nurs.
2000;100:44-8. [PubMed]
---------------------------------------------------------------------------

Insulin pens are designed to facilitate easy self-administration,
the possession of which would suggest the ability to self-inject.
Additionally, insulin pens often come pre-filled with insulin or must
be used with a pre-filled cartridge thus potentially negating the need
for skilled nursing for the purpose of calculating and filling
appropriate doses. It is recognized that visual impairment, joint
immobility and/or pain, peripheral neuropathy, and cognitive issues may
affect the ability of elderly patients to determine correct insulin
dosing and injection. Our literature review indicates that insulin pen
devices may be beneficial in terms of safety for elderly patients due
to these visual or physical disabilities.\23\ To determine whether to
use a traditional vial and syringe method of insulin administration
versus an insulin pen, the physician must consider and understand the
advantages these devices offer over traditional vials and syringes.
These advantages include:
---------------------------------------------------------------------------

\23\ Wright, B., Bellone, J., McCoy, E. (2010). A review of
insulin pen devices and use in elderly, diabetic population.
Clinical Medicine Insights: Endocrinology and Diabetes. 3:53-63.
Doi: 10.4137/CMED.S5534.
---------------------------------------------------------------------------

Convenience, as the insulin pen eliminates the need to
draw up a dose;
Greater dose accuracy and reliability, especially for low
doses which are often needed in the elderly;
Sensory and auditory feedback associated with the dial
mechanism on many pens may also benefit those with visual impairments;
Pen devices are also more compact, portable and easier to
grip, which may benefit those with impairments in manual dexterity; and
Less painful injections and overall ease of use.\24\
---------------------------------------------------------------------------

\24\ Wright, B., Bellone, J., McCoy, E. (2010). A review of
insulin pen devices and use in elderly, diabetic population.
Clinical Medicine Insights: Endocrinology and Diabetes. 3:53-63.
Doi: 10.4137/CMED.S5534.
---------------------------------------------------------------------------

Although pen devices are often perceived to be more costly than
vialed insulin, study results indicate that elderly diabetic patients
are more likely to accept pen devices and adhere to therapy, which
leads to better glycemic control that decreases long-term complications
and associated healthcare costs.\25\ The significantly improved safety
profiles of pen devices also avert costly episodes of hypoglycemia.\26\
It also should be noted that most insurance plans, including Medicare
Part D plans, charge the patient the same amount for a month supply of
insulin in the pen device as insulin in the vial.\27\ Furthermore,
pharmacoeconomic data reveal cost benefits for using pens versus
syringes due to improved treatment adherence and reduced health care
utilization.\28\ Additionally, in some cases the individual with
coverage for insulin pens may have one co-pay, resulting in getting
more insulin than if purchasing a vial. And, there is less waste with
pens because insulin vials should be discarded after 28 days after
opening. However, there may be clinical reasons for the use of the
traditional vial and insulin syringe as opposed to the insulin pen,
including the fact that not all insulin preparations are available via
insulin pen. In such circumstances, there are multiple assistive aids
and devices to facilitate self-injection of insulin for those with
cognitive or functional limitations. These include: nonvisual insulin
measurement devices; syringe magnifiers; needle guides; prefilled
insulin syringes; and vial stabilizers to help ensure accuracy and aid
in insulin delivery.\29\ It is expected that providers will assess the
needs, abilities, and preference of the patient requiring insulin to
facilitate patient autonomy, efficiency, and safety in diabetes self-
management, including the administration of insulin.
---------------------------------------------------------------------------

\25\ Strategies for Insulin Injection Therapy in Diabetes Self-
Management. (2011). American Association of Diabetes Educators.
\26\ Strategies for Insulin Injection Therapy in Diabetes Self-
Management. (2011). American Association of Diabetes Educators.
\27\ Wright, B., Bellone, J., McCoy, E. (2010). A review of
insulin pen devices and use in elderly, diabetic population.
Clinical Medicine Insights: Endocrinology and Diabetes. 3:53-63.
Doi: 10.4137/CMED.S5534
\28\ Strategies for Insulin Injection Therapy in Diabetes Self-
Management. (2011). American Association of Diabetes Educators.
\29\ Strategies for Insulin Injection Therapy in Diabetes Self-
Management. (2011). American Association of Diabetes Educators.
---------------------------------------------------------------------------

Further research regarding self-injection of insulin, whether via a
vial and syringe method or insulin pen, shows that education for
starting insulin and monitoring should be provided by a diabetes nurse
specialist, and typically entails 5 to 10 face-to-face contacts either
in the patient's home or at the diabetes clinic; these are in addition
to telephone contacts to further reinforce teaching and to answer
patient questions.\30\ This type of assessment and education allows for
patient autonomy and self-efficiency and is often a preferred mode for
diabetes self-management.
---------------------------------------------------------------------------

\30\ Hendra, T.J. Starting insulin therapy in elderly patients.
(2012). Journal of the Royal Society of Medicine. 95(9), 453-455.
http://www.ncbi.nlm.nih.gov.
---------------------------------------------------------------------------

In the CY 2014 HH PPS final rule (78 FR 72256), we noted ``The
Office of Inspector General (OIG) released a ``Management Implications
Report in August of 2013'' that concluded there is a ``systemic
weakness that results in Medicare coverage of unnecessary home health
care for diabetic patients''. The OIG report noted that investigations
show that the majority of beneficiaries involved in fraudulent schemes
have a primary diagnosis of diabetes. The report noted that OIG Special
Agents found falsified medical records documenting patients having hand
tremors and poor vision preventing them from drawing insulin into a
syringe, visually verifying the correct dosage, and injecting the
insulin themselves, when the patients did not in fact suffer those
symptoms.
In light of the OIG report, we conducted analysis and performed
simulations using CY 2012 claims data and described our findings in the
CY 2014 Home Health PPS Final Rule (78 FR 72310). We found that nearly
44 percent of the episodes that would qualify for outlier payments had
a primary diagnosis of diabetes and 16 percent of episodes that would
quality for outlier payments had a primary diagnosis of ``Diabetes
mellitus without mention of complication, type II or unspecified type,
not stated as uncontrolled.'' Qualifying for outlier

[[Page 38403]]

payments should indicate an increased resource and service need.
However, uncomplicated and controlled diabetes typically would be
viewed as stable without clinical complications and would not warrant
increased resource and service needs nor would it appear to warrant
outlier payments. Our simulations estimated that approximately 81
percent of outlier payments would be paid to proprietary HHAs and that
approximately two-thirds of outlier payments would be paid to HHAs
located in Florida (27 percent), Texas (24 percent) and California (15
percent). We also conducted additional analyses on episodes in our
simulations that would have resulted in outlier payments of over
$10,000. Of note, 95 percent of episodes that would have resulted in
outlier payments of over $10,000 were for patients with a primary
diagnosis of diabetes or long-term use of insulin, and most were
concentrated in Florida, Texas, New York, California, and Oklahoma. On
average, these outlier episodes had 160 skilled nursing visits in a 60-
day episode of care.\31\
---------------------------------------------------------------------------

\31\ This analysis simulated payments using CY 2012 claims data
and CY 2012 payment rates. The simulations did not take into account
the 10-percent outlier cap. Some episodes may have qualified for
outlier payments in the simulations, but were not paid accordingly
if the HHA was at or over its 10 percent cap on outlier payments as
a percent of total payments.
---------------------------------------------------------------------------

Based upon the initial data analysis described above and the
information found in the literature review, we conducted further data
analysis with more recent home health claims and OASIS data (CY 2012
and CY 2013) to expand our understanding of the diabetic patient in the
home health setting. Specifically, we investigated the extent to which
beneficiaries with a diabetes-related principal diagnosis received home
health services likely for the primary purpose of insulin injection
assistance and whether such services were warranted by other documented
medical conditions. We also analyzed the magnitude of Medicare payments
associated with home health services provided to this population of
interest. The analysis was conducted by Acumen, LLC because of their
capacity to provide real-time claims data analysis across all parts of
the Medicare program (that is, Part A, Part B, and Part D).
Our analysis began with identifying episodes for the home health
diabetic population based on claims and OASIS assessments most likely
to be associated with insulin injection assistance. We used the
following criteria to identify the home health diabetic population of
interest: (1) A diabetic condition listed as the principal/primary
diagnosis on the home health claim; (2) Medicare Part A or Part B
enrollment for at least three months prior to the episode and during
the episode; and (3) episodes with at least 45 skilled visits. This
threshold was determined based on the distribution in the average
number and length of skilled nursing visits for episodes meeting
criteria 1 and 2 above using CY 2013 home health claims data. The
average number of skilled nursing visits for beneficiaries who receive
at least one skilled nursing visit appeared to increase from 20 visits
at the 90th percentile, to 50 visits at the 95th percentile.
Additionally, the average length of a skilled nursing visit for
episodes between the 90th and 95th percentiles was 37 minutes, less
than half the length of visits for episode between the 75th and 90th
percentiles.
Approximately 49,100 episodes met the study population criteria
described above, accounting for approximately $298 million in Medicare
home health payments in CY 2013. Of the 49,100 episodes of interest, 71
percent received outlier payments and, on average, there were 86
skilled nursing visits per episode. In addition, 12 percent of the
episodes in the study population were for patients prescribed an
insulin pen to self-inject and more than half of the episodes billed
(27,439) were for claims that listed ICD-9-CM 2500x, ``Diabetes
Mellitus without mention of complication'', as the principal diagnosis
code. ICD-9-CM describes the code 250.0x as diabetes mellitus without
mention of complications (complications can include hypo- or
hyperglycemia, or manifestations classified as renal, ophthalmic,
neurological, peripheral circulatory damage or neuropathy). Clinically,
this code generally means that the diabetes is being well-controlled
and there are no apparent complications or symptoms resulting from the
diabetes. Diabetes that is controlled and without complications does
not warrant intensive intervention or daily skilled nursing visits;
rather, it warrants knowledge of the condition and routine monitoring.
As discussed above in this section, the traditional vial and
syringe method of insulin administration is one of two methods of
insulin administration (excluding the use of insulin pumps). The
alternative to the traditional vial and syringe method is the use of
insulin pens. We believe that insulin pens are usually prescribed for
those beneficiaries that are able to self-administer the insulin via an
insulin pen. Therefore, the possession of a prescribed insulin pen
would suggest the ability to self-inject. Since insulin pens often come
pre-filled with insulin or must be used with a pre-filled cartridge, we
believe there would not be a need for skilled nursing for the purpose
of insulin injection assistance. We expect providers to assess the
needs, abilities, and preference of the patient requiring insulin to
facilitate patient autonomy, efficiency, and safety in diabetes self-
management, including the administration of insulin. As noted above,
approximately 12 percent of the episodes in the study population with
visits likely for the purpose of insulin injection assistance were for
patients prescribed an insulin pen to self-inject, which does not
conform to our current policy that home health visits for the sole
purpose of insulin injection assistance is limited to patients that are
physically or mentally unable to self-inject and there is no other
person who is able and willing to inject the patient.
Furthermore, we recognize that our current sub-regulatory guidance
may not adequately address the method of delivery. We are considering
additional guidance that may be necessary surrounding insulin injection
assistance provided via a pen based upon our analyses described above.
We have found that literature supports that insulin pens may reduce
expenses for the patient in the form of co-pays and may increase
patient adherence to their treatment plan. Therefore, we encourage
physicians to consider the potential benefits derived in prescribing
insulin pens, when clinically appropriate, given the patient's
condition.
We also investigated whether secondary diagnosis codes listed on
home health claims support that the patient, either for physical or
mental reasons, cannot self-inject. Our contractor, Abt Associates,
with review and clinical input from CMS clinical staff and experts,
created a list of ICD-9-CM codes that indicate a patient has
impairments in dexterity, cognition, vision, and/or hearing that may
cause the patient to be unable to self-inject insulin. We found that 49
percent of home health episodes in our study population did not have a
secondary diagnosis from that ICD-9-CM code list on the home health
claim that supported that the patient was physically or mentally unable
to self-inject. When examining only the initial home health episodes of
our study population, we found that 67 percent of initial home health
episodes with skilled nursing visits likely for insulin injections did
not have a secondary diagnosis on the home health claim that supported
that the patient was physically or mentally unable to self-

[[Page 38404]]

inject. Using the same list of ICD-9-CM diagnosis codes, we examined
both the secondary diagnoses on the home health claim and diagnoses on
non-home health claims in the three months prior to starting home
health care for initial home health episodes. We found that for initial
home health episodes in our study population that the percentage of
episodes that did not have a secondary diagnosis to support that the
patient cannot self-inject would decrease from 67 percent to 47 percent
if the home health claim included diagnoses found in other claim types
during the three months prior to entering home care. We do recognize
that, in spite of all of the education, assistive devices and support,
there may still be those who are unable to self-inject insulin and will
require ongoing skilled nursing visits for insulin administration
assistance. However, there is an expectation that the physician and the
HHA would clearly document detailed clinical findings and rationale as
to why an individual is unable to self-inject, including the reporting
of an appropriate secondary condition that supports the inability of
the patient to self-inject.
As described above, a group of CMS clinicians and contractor
clinicians developed a list of conditions that would support the need
for ongoing home health skilled nursing visits for insulin injection
assistance for instances where the patient is physically or mentally
unable to self-inject and there is no able or willing caregiver to
provide assistance. We expect the conditions included in Table 28 to be
listed on the claim and OASIS to support the need for skilled nursing
visits for insulin injection assistance.

Table 28--ICD-9-CM Diagnosis Codes That Indicate a Potential Inability
To Self-Inject Insulin
------------------------------------------------------------------------
ICD-9-CM Code Description
------------------------------------------------------------------------
Amputation:
V49.61............................... Thumb Amputation Status.
V49.63............................... Hand Amputation Status.
V49.64............................... Wrist Amputation Status.
V49.65............................... Below elbow amputation status.
V49.66............................... Above elbow amputation status.
V49.67............................... Shoulder amputation status.
885.0................................ Traumatic amputation of thumb w/o
mention of complication.
885.1................................ Traumatic amputation of thumb w/
mention of complication.
886.0................................ Traumatic amputation of other
fingers w/o mention of
complication.
886.1................................ Traumatic amputation of other
fingers w/mention of
complication.
887.0................................ Traumatic amputation of arm and
hand, unilateral, below elbow w/
o mention of complication.
887.1................................ Traumatic amputation of arm and
hand, unilateral, below elbow,
complicated.
887.2................................ Traumatic amputation of arm and
hand, unilateral, at or above
elbow w/o mention of
complication.
887.3................................ Traumatic amputation of arm and
hand, unilateral, at or above
elbow, complicated.
887.4................................ Traumatic amputation of arm and
hand, unilateral, level not
specified, w/o mention of
complication.
887.5................................ Traumatic amputation of arm and
hand, unilateral, level not
specified, complicated.
887.6................................ Traumatic amputation of arm and
hand, bilateral, any level, w/o
mention of complication.
887.7................................ Traumatic amputation of arm and
hand, bilateral, any level,
complicated.
Vision:
362.01............................... Background diabetic retinopathy.
362.50............................... Macular degeneration (senile) of
retina unspecified.
362.51............................... Nonexudative senile macular
degeneration of retina.
362.52............................... Exudative senile macular
degeneration of retina.
362.53............................... Cystoid macular degeneration of
retina.
362.54............................... Macular cyst hole or pseudohole
of retina.
362.55............................... Toxic maculopathy of retina.
362.56............................... Macular puckering of retina.
362.57............................... Drusen (degenerative) of retina.
366.00............................... Nonsenile cataract unspecified.
366.01............................... Anterior subcapsular polar
nonsenile cataract.
366.02............................... Posterior subcapsular polar
nonsenile cataract.
366.03............................... Cortical lamellar or zonular
nonsenile cataract.
366.04............................... Nuclear nonsenile cataract.
366.09............................... Other and combined forms of
nonsenile cataract.
366.10............................... Senile cataract unspecified.
366.11............................... Pseudoexfoliation of lens
capsule.
366.12............................... Incipient senile cataract.
366.13............................... Anterior subcapsular polar senile
cataract.
366.14............................... Posterior subcapsular polar
senile cataract.
366.15............................... Cortical senile cataract.
366.16............................... Senile nuclear sclerosis.
366.17............................... Total or mature cataract.
366.18............................... Hypermature cataract.
366.19............................... Other and combined forms of
senile cataract.
366.20............................... Traumatic cataract unspecified.
366.21............................... Localized traumatic opacities.
366.22............................... Total traumatic cataract.
366.23............................... Partially resolved traumatic
cataract.
366.8................................ Other cataract.
366.9................................ Unspecified cataract.
366.41............................... Diabetic cataract.
366.42............................... Tetanic cataract.
366.43............................... Myotonic cataract.

[[Page 38405]]

366.44............................... Cataract associated with other
syndromes.
366.45............................... Toxic cataract.
366.46............................... Cataract associated with
radiation and other physical
influences.
366.50............................... After-cataract unspecified.
369.00............................... Impairment level not further
specified.
369.01............................... Better eye: total vision
impairment; lesser eye: total
vision impairment.
369.10............................... Moderate or severe impairment,
better eye, impairment level not
further specified.
369.11............................... Better eye: severe vision
impairment; lesser eye: blind
not further specified.
369.13............................... Better eye: severe vision
impairment; lesser eye: near-
total vision impairment.
369.14............................... Better eye: severe vision
impairment; lesser eye: profound
vision impairment.
369.15............................... Better eye: moderate vision
impairment; lesser eye: blind
not further specified.
369.16............................... Better eye: moderate vision
impairment; lesser eye: total
vision impairment.
369.17............................... Better eye: moderate vision
impairment; lesser eye: near-
total vision impairment.
369.18............................... Better eye: moderate vision
impairment; lesser eye: profound
vision impairment.
369.20............................... Moderate to severe impairment;
Low vision both eyes not
otherwise specified.
369.21............................... Better eye: severe vision
impairment; lesser eye;
impairment not further
specified.
369.22............................... Better eye: severe vision
impairment; lesser eye: severe
vision impairment.
369.23............................... Better eye: moderate vision
impairment; lesser eye:
impairment not further
specified.
369.24............................... Better eye: moderate vision
impairment; lesser eye: severe
vision impairment.
369.25............................... Better eye: moderate vision
impairment; lesser eye: moderate
vision impairment.
369.3................................ Unqualified visual loss both
eyes.
369.4................................ Legal blindness as defined in
U.S.A..
377.75............................... Cortical blindness.
379.21............................... Vitreous degeneration.
379.23............................... Vitreous hemorrhage.
Cognitive/Behavioral:
290.0................................ Senile dementia uncomplicated.
290.3................................ Senile dementia with delirium.
290.40............................... Vascular dementia, uncomplicated.
290.41............................... Vascular dementia, with delirium.
290.42............................... Vascular dementia, with
delusions.
290.43............................... Vascular dementia, with depressed
mood.
294.11............................... Dementia in conditions classified
elsewhere with behavioral
disturbance.
294.21............................... Dementia, unspecified, with
behavioral disturbance.
300.29............................... Other isolated or specific
phobias.
331.0................................ Alzheimer's disease.
331.11............................... Pick's disease.
331.19............................... Other frontotemporal dementia.
331.2................................ Senile degeneration of brain.
331.82............................... Dementia with lewy bodies.
Arthritis:
715.11............................... Osteoarthrosis localized primary
involving shoulder region.
715.21............................... Osteoarthrosis localized
secondary involving shoulder
region.
715.31............................... Osteoarthrosis localized not
specified whether primary or
secondary involving shoulder
region.
715.91............................... Osteoarthrosis unspecified
whether generalized or localized
involving shoulder region.
715.12............................... Osteoarthrosis localized primary
involving upper arm.
715.22............................... Osteoarthrosis localized
secondary involving upper arm.
715.32............................... Osteoarthrosis localized not
specified whether primary or
secondary involving upper arm.
715.92............................... Osteoarthrosis unspecified
whether generalized or localized
involving upper arm.
715.13............................... Osteoarthrosis localized primary
involving forearm.
715.23............................... Osteoarthrosis localized
secondary involving forearm.
715.33............................... Osteoarthrosis localized not
specified whether primary or
secondary involving forearm.
715.93............................... Osteoarthrosis unspecified
whether generalized or localized
involving forearm.
715.04............................... Osteoarthrosis generalized
involving hand.
715.14............................... Osteoarthrosis localized primary
involving hand.
715.24............................... Osteoarthrosis localized
secondary involving hand.
715.34............................... Osteoarthrosis localized not
specified whether primary or
secondary involving hand.
715.94............................... Osteoarthrosis unspecified
whether generalized or localized
involving hand.
716.51............................... Unspecified polyarthropathy or
polyarthritis involving shoulder
region.
716.52............................... Unspecified polyarthropathy or
polyarthritis involving upper
arm.
716.53............................... Unspecified polyarthropathy or
polyarthritis involving forearm.
716.54............................... Unspecified polyarthropathy or
polyarthritis involving hand.
716.61............................... Unspecified monoarthritis
involving shoulder region.
716.62............................... Unspecified monoarthritis
involving upper arm.
716.63............................... Unspecified monoarthritis
involving forearm.
716.64............................... Unspecified monoarthritis
involving hand.
716.81............................... Other specified arthropathy
involving shoulder region.
716.82............................... Other specified arthropathy
involving upper arm.
716.83............................... Other specified arthropathy
involving forearm.
716.84............................... Other specified arthropathy
involving hand.
716.91............................... Unspecified arthropathy involving
shoulder region.
716.92............................... Unspecified arthropathy involving
upper arm.

[[Page 38406]]

716.93............................... Unspecified arthropathy involving
forearm.
716.94............................... Unspecified arthropathy involving
hand.
716.01............................... Kaschin-Beck disease shoulder
region.
716.02............................... Kaschin-Beck disease upper arm.
716.04............................... Kaschin-Beck disease forearm.
716.04............................... Kaschin-beck disease involving
hand.
719.81............................... Other specified disorders of
joint of shoulder region.
719.82............................... Other specified disorders of
upper arm joint.
719.83............................... Other specified disorders of
joint, forearm.
719.84............................... Other specified disorders of
joint, hand.
718.41............................... Contracture of joint of shoulder
region.
718.42............................... Contracture of joint, upper arm.
718.43............................... Contracture of joint, forearm.
718.44............................... Contracture of hand joint.
714.0................................ Rheumatoid arthritis.
Movement Disorders:
332.0................................ Paralysis agitans (Parkinson's).
332.1................................ Secondary parkinsonism.
333.1................................ Essential and other specified
forms of tremor.
736.05............................... Wrist drop (acquired).
After Effects from Stroke/Other
Disorders of the Central Nervous
System/Intellectual Disabilities:
438.21............................... Hemiplegia affecting dominant
side.
438.22............................... Hemiplegia affecting nondominant
side.
342.01............................... Flaccid hemiplegia and
hemiparesis affecting dominant
side.
342.02............................... Flaccid hemiplegia and
hemiparesis affecting
nondominant side.
342.11............................... Spastic hemiplegia and
hemiparesis affecting dominant
side.
342.12............................... Spastic hemiplegia and
hemiparesis affecting
nondominant side.
438.31............................... Monoplegia of upper limb
affecting dominant side.
438.32............................... Monoplegia of upper limb
affecting nondominant side.
343.3................................ Congenital monoplegia.
344.41............................... Monoplegia of upper limb
affecting dominant side.
344.42............................... Monoplegia of upper limb
affecting nondominant side.
344.81............................... Locked-in state.
344.00............................... Quadriplegia unspecified.
344.01............................... Quadriplegia c1-c4 complete.
344.02............................... Quadriplegia c1-c4 incomplete.
344.03............................... Quadriplegia c5-c7 complete.
344.04............................... Quadriplegia c5-c7 incomplete.
343.0................................ Congenital diplegia.
343.2................................ Congenital quadriplegia.
344.2................................ Diplegia of upper limbs.
318.0................................ Moderate intellectual
disabilities.
318.1................................ Severe intellectual disabilities.
318.2................................ Profound intellectual
disabilities.
------------------------------------------------------------------------

Although we are not proposing any policy changes at this time, we
are soliciting public comments on whether the conditions in Table 28
represent a comprehensive list of codes that appropriately indicate
that a patient may not be able to self-inject and the use of insulin
pens in home health. We plan to continue monitoring claims that are
likely for the purpose of insulin injection assistance. Historical
evidence in the medical record must support the clinical legitimacy of
the secondary condition(s) and resulting disability that limit the
beneficiary's ability to self-inject.

G. Implementation of the International Classification of Diseases, 10th
Revision, Clinical Modification (ICD-10-CM)

On April 1, 2014, the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) was enacted. Section 212 of the PAMA, titled
``Delay in Transition from ICD-9 to ICD-10 Code Sets,'' provides that
``[t]he Secretary of Health and Human Services may not, prior to
October 1, 2015, adopt ICD-10 code sets as the standard for code sets
under section 1173(c) of the Social Security Act (42 U.S.C. 1320d-2(c))
and Sec. 162.1002 of title 45, Code of Federal Regulations.''
On May 1, 2014, the Secretary announced that HHS expects to issue
an interim final rule that will require use of ICD-10 beginning October
1, 2015 and continue to require use of ICD-9-CM through September 30,
2015. This announcement, which is available on the CMS Web site at
http://cms.gov/Medicare/Coding/ICD10/index.html, means that ICD-9-CM
diagnosis codes will continue to be used for home health claims
reporting until October 1, 2015, when ICD-10-CM is required. Diagnosis
reporting on home health claims must adhere to ICD-9-CM coding
conventions and guidelines regarding the selection of principal
diagnosis and the reporting of additional diagnoses until that time.
The current ICD-9-CM Coding Guidelines refer to the use of the
International Classification of Diseases,

[[Page 38407]]

9th Revision, Clinical Modification (ICD-9-CM) and are available
through the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html or on the CDC's Web site at
http://www.cdc.gov/nchs/icd/icd9cm.htm. We plan to disseminate this
information through the HHA Center Web site, the Home Health, Hospice
and DME Open Door Forum, and in the CY 2015 HH PPS final rule.

H. Proposed Change to the Therapy Reassessment Timeframes

As discussed in our CY 2011 HH PPS final rule (75 FR 70372),
effective January 1, 2011, therapy reassessments must be performed on
or ``close to'' the 13th and 19th therapy visits and at least once
every 30 days. A qualified therapist, of the corresponding discipline
for the type of therapy being provided, must functionally reassess the
patient using a method which would include objective measurement. The
measurement results and corresponding effectiveness of the therapy, or
lack thereof, must be documented in the clinical record. We anticipated
that policy regarding therapy coverage and therapy reassessments would
address payment vulnerabilities that have led to high use and sometimes
overuse of therapy services. We also discussed our expectation that
this policy change would ensure more qualified therapist involvement
for beneficiaries receiving high amounts of therapy. In our CY 2013 HH
PPS final rule (77 FR 67068), effective January 1, 2013, we provided
further clarifications regarding therapy coverage and therapy
reassessments. Specifically, similar to the existing requirements for
therapy reassessments when the patient resides in a rural area, we
finalized changes to Sec. 409.44(c)(2)(i)(C)(2) and (D)(2) specifying
that when multiple types of therapy are provided, each therapist must
assess the patient after the 10th therapy visit but no later than the
13th therapy visit and after the 16th therapy visit but no later than
the 19th therapy visit for the plan of care. In Sec.
409.44(c)(2)(i)(E)(1), we specified that when a therapy reassessment is
missed, any visits for that discipline prior to the next reassessment
are non-covered.
Our analysis of data from CYs 2010 through 2013 shows that the
frequency of episodes with therapy visits reaching 14 and 20 therapy
visits did not change substantially as a result of the therapy
reassessment policy implemented in CY 2011 (see Table 29). The
percentage of episodes with at least 14 covered therapy visits was 17.2
percent in CY 2010 and decreased to 16.0 percent in CY 2011. In CY 2013
the percentage of episodes with at least 14 covered therapy visits
increased to 16.3 percent. Likewise, the percentage of episodes with at
least 20 covered therapy visits was 6.0 percent in CY 2010 and
decreased to 5.4 percent in CY 2011. In CY 2013, the percentage of
episodes with at least 20 covered therapy visits was 5.3 percent. We
analyzed data for specific types of providers (for example, non-profit,
for profit, freestanding, facility-based), and we found the similar
trends in the number of episodes with at least 14 and 20 covered
therapy visits. For example, for non-profit HHAs, the percentage of
episodes with at least 14 covered therapy visits decreased from 11.8
percent in CY 2010 to 11.1 in CY 2011 and episodes with at least 20
covered therapy visits decreased from 4.2 percent in CY 2010 to 3.9
percent in CY 2011. For proprietary HHAs, the percentage of episodes
with at least 14 covered therapy visits decreased from 19.7 percent in
CY 2010 to 18.2 percent in CY 2011 and episodes with at least 20
covered therapy visits decreased from 6.8 percent in CY 2010 to 6.1
percent in CY 2011.
As we stated in section III.A of this proposed rule, in addition to
the implementation of the therapy reassessment requirements in CY 2011,
HHAs were also subject to the Affordable Care Act face-to-face
encounter requirement, payments were reduced to account for increases
nominal case-mix, and the Affordable Care Act mandated that the HH PPS
payment rates be reduced by 5 percent to pay up to, but no more than
2.5 percent of total HH PPS payments as outlier payments. The estimated
net impact to HHAs for CY 2011 was a decrease in total HH PPS payments
of 4.78 percent. The independent effects of any one policy may be
difficult to discern in years where multiple policy changes occur in
any given year. We note that in our CY 2012 HH PPS final rule (76 FR
68526), we recalibrated and reduced the HH PPS case-mix weights for
episodes reaching 14 and 20 therapy visits, thereby greatly diminishing
the payment incentive for episodes at those therapy thresholds.

Table 29--Percentage of Episodes With 14 and 20 Therapy Visits, CY 2010 Through 2013
----------------------------------------------------------------------------------------------------------------
Episodes with at Episodes with at Episodes with at
Calendar year least 1 covered least 14 covered least 20 covered
therapy visit therapy visits therapy visits
----------------------------------------------------------------------------------------------------------------
2010................................................... 54.1% 17.2% 6.0%
2011................................................... 54.2% 16.0% 5.4%
2012................................................... 55.2% 15.6% 5.2%
2013................................................... 56.3% 16.3% 5.3%
----------------------------------------------------------------------------------------------------------------
Source: CY 2010 claims from the Datalink file and CY 2011 through CY 2013 claims from the standard analytic file
(SAF).
Note(s): For CY 2010, we included all episodes that began on or after January 1, 2010 and ended on or before
December 31, 2010 and we included a 20% sample of episodes that began in CY 2009 but ended in CY 2010. For CY
2011 and CY 2013, we included all episodes that ended on or before December 31 of that CY (including 100% of
episodes that began in the previous CY, but ended in the current CY).

Since the therapy reassessment requirements were implemented in CY
2011, providers have expressed frustration regarding the timing of
reassessments for multi-discipline therapy episodes. In multiple
therapy episodes, therapists must communicate when a planned visit and/
or reassessment is missed to accurately track and count visits.
Otherwise, therapy reassessments may be in jeopardy of not being
performed during the required timeframe increasing the risk of
subsequent visits being non-covered. As stated above, our recent
analysis of claims data from CY 2010 through CY 2013 shows no
significant change in the percentage of cases reaching the 14 therapy
visit and 20 therapy visit thresholds between CY 2010 and CY 2011.
Moreover, payment increases at the 14 therapy visit and 20 therapy
visit thresholds have been mitigated since the recalibration of the
case-mix weights in CY 2012. Therefore, we propose to simplify Sec.
409.44(c)(2) to require a qualified therapist (instead of an assistant)
from each discipline to provide the needed therapy service and
functionally reassess the patient in

[[Page 38408]]

accordance with Sec. 409.44(c)(2)(i)(A) at least every 14 calendar
days.
The requirement to perform a therapy reassessment at least once
every 14 calendar days would apply to all episodes regardless of the
number of therapy visits provided. All other requirements related to
therapy reassessments would remain unchanged, such as a qualified
therapist (instead of an assistant), from each therapy discipline
provided, would still be required to provide the ordered therapy
service and functionally reassess the patient using a method which
would include objective measurements. The measurement results and
corresponding effectiveness of the therapy, or lack thereof, would be
documented in the clinical record. We believe that revising this
requirement would make it easier and less burdensome for HHAs to track
and to schedule therapy reassessments every 14 calendar days as opposed
to tracking and counting therapy visits, especially for multiple-
discipline therapy episodes. We also believe that this proposal would
reduce the risk of non-covered visits so that therapists could focus
more on providing quality care for their patients, while still
promoting therapist involvement and quality treatment for all
beneficiaries, regardless of the level of therapy provided.
We invite comment on this proposal and the associated change in the
regulation at Sec. 409.44 in section VI. of this proposed rule.

I. HHA Value-Based Purchasing Model

As we discussed previously in the FY 2009 proposed rule for Skilled
Nursing Facilities (73 FR 25918, 25932, May 7, 2008), value-based
purchasing (VBP) programs, in general, are intended to tie a provider's
payment to its performance in such a way as to reduce inappropriate or
poorly furnished care and identify and reward those who furnish quality
patient care. Section 3006(b)(1) of the Affordable Care Act directed
the Secretary to develop a plan to implement a VBP program for home
health agencies (HHAs) and to issue an associated Report to Congress
(Report). The Secretary issued that Report, which is available online
at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/downloads/stage-2-NPRM.PDF.
The Report included a roadmap for HHA VBP implementation. The
Report outlined the need to develop a HHA VBP program that aligns with
other Medicare programs and coordinates incentives to improve quality.
The Report indicated that a HHA VBP program should build on and refine
existing quality measurement tools and processes. In addition, the
Report indicated that one of the ways that such a program could link
payment to quality would be to tie payments to overall quality
performance.
Section 402 of Public Law 92-603 provided authority for the CMS to
conduct the Home Health Pay-for-Performance (HHPFP) Demonstration that
ran from 2008 to 2010. The results of that Demonstration found limited
quality improvement in certain measures after comparing the quality of
care furnished by Demonstration participants to the quality of care
furnished by the control group. One important lesson learned from the
HHPFP Demonstration was the need to link the home health agency's
quality improvement efforts and the incentives. HHAs in three of the
four regions generated enough savings to have incentive payments in the
first year of the Demonstration, but the size of payments were unknown
until after the conclusion of the Demonstration. This time lag on
paying incentive payments did not provide a sufficient incentive to
HHAs to make investments necessary to improve quality. The
Demonstration suggested that future models could benefit from ensuring
that incentives are reliable enough, of sufficient magnitude, and paid
in a timely fashion to encourage HHAs to be fully engaged in the
quality of care initiative. The evaluation report is available online
at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Reports/Downloads/HHP4P_Demo_Eval_Final_Vol1.pdf.
We have already successfully implemented the Hospital Value-Based
Purchasing (HVBP) program where 1.25 percent of hospital payments in FY
2014 are tied to the quality of care that the hospitals provide. This
percentage amount will gradually increase to 2.0 percent in FY 2017 and
subsequent years. The President's 2015 Budget proposes that value-based
purchasing should be extended to additional providers including skilled
nursing facilities, home health agencies, ambulatory surgical centers,
and hospital outpatient departments. Therefore, we are now considering
testing a HHA VBP model that builds on what we have learned from the
HVBP program. The model also presents an opportunity to test whether
larger incentives than what have been previously tested will lead to
even greater improvement in the quality of care furnished to
beneficiaries. The HHA VBP model that is being considered would offer
both a greater potential reward for high performing HHAs as well as a
greater potential downside risk for low performing HHAs. If
implemented, the model would begin at the outset of CY 2016, and
include an array of measures that can capture the multiple dimensions
of care that HHAs furnish. Building upon the successes of other related
programs, we are seeking to implement a model with greater upside
benefit and downside risk to motivate HHAs to make the substantive
investments necessary to improve the quality of care furnished by HHAs.
As currently envisioned, the HHA VBP model would reduce or increase
Medicare payments, in a 5-8 percent range, depending on the degree of
quality performance in various measures to be selected. The model would
apply to all HHAs in each of the projected five to eight states
selected to participate in the model. The distribution of payments
would be based on quality performance, as measured by both achievement
and improvement across multiple quality measures. Some HHAs would
receive higher payments than standard fee-for-service payments and some
HHAs would receive lower payments, similar to the HVBP program. We
believe the payment adjustment at risk would provide an incentive among
all HHAs to provide significantly better quality through improved
planning, coordination, and management of care. To be eligible for any
incentive payments, HHAs would need to achieve a minimal threshold in
quality performance with respect to the care that they furnish. The
size of the award would be dependent on the level of quality furnished
above the minimal threshold with the highest performance awards going
to HHAs with the highest overall level of or improvement in quality.
HHAs that meet or exceed the performance standards based on quality
and efficiency metrics would be eligible to earn performance payments.
The size of the performance payment would be dependent upon the
provider's performance relative to other HHAs within its participating
state. HHAs that exceed the performance standards and demonstrate the
greatest level of overall quality or quality improvement on the
selected measures would have the opportunity to receive performance
payment adjustments greater than the amount of the payment reduction,
and would therefore see a net payment increase as a result of this
model. Those HHAs that fail to meet the performance standard would
receive lower payments than what would have been reimbursed

[[Page 38409]]

under the traditional FFS Medicare payment system, and would therefore
see a net payment decrease to Medicare payments as a result of this
model. We are proposing to use the waiver authority under section 1115A
of the Act to waive the applicable Medicare payment provisions for HHAs
in the selected states and apply a reduction or increase to current
Medicare payments to these HHAs, which would be dependent on their
performance.
We are considering an HHA VBP model in which participation by all
HHAs in five to eight selected states is mandatory. We believe
requiring all HHAs in selected states to participate in the model will
ensure that: (1) There is no selection bias, (2) participating HHAs are
representative of HHAs nationally, and (3) there is sufficient
participation to generate meaningful results. In our experience,
providers are generally reluctant to participate voluntarily in models
in which their Medicare payments are subject to reduction. In this
proposed rule, we invite comments on the HHA VBP model outlined above,
including elements of the model, size of the payment incentives and
percentage of payments that would need to be placed at risk in order to
spur HHAs to make the necessary investments to improve the quality of
care for Medicare beneficiaries, the timing of the incentive payments,
and how performance payments should be distributed. We also invite
comments on the best approach for selecting states for participation in
this model. Approaches could include: (1) Selecting states randomly,
(2) selecting states based on quality, utilization, health IT, or
efficiency metrics or a combination, or (3) other considerations.
We note that if we decide to move forward with the implementation
of this HHA VBP model in CY 2016, we intend to invite additional
comments on a more detailed model proposal to be included in future
rulemaking.

J. Advancing Health Information Exchange

HHS believes all patients, their families, and their healthcare
providers should have consistent and timely access to their health
information in a standardized format that can be securely exchanged
between the patient, providers, and others involved in the patient's
care. (HHS August 2013 Statement, ``Principles and Strategies for
Accelerating Health Information Exchange.'') The Department is
committed to accelerating health information exchange (HIE) through the
use of electronic health records (EHRs) and other types of health
information technology (HIT) across the broader care continuum through
a number of initiatives including: (1) Alignment of incentives and
payment adjustments to encourage provider adoption and optimization of
HIT and HIE services through Medicare and Medicaid payment policies,
(2) adoption of common standards and certification requirements for
interoperable HIT, (3) support for privacy and security of patient
information across all HIE-focused initiatives, and (4) governance of
health information networks. These initiatives are designed to
encourage HIE among all health care providers, including professionals
and hospitals eligible for the Medicare and Medicaid EHR Incentive
Programs and those who are not eligible for the EHR Incentive programs,
and are designed to improve care delivery and coordination across the
entire care continuum. To increase flexibility in the Office of the
National Coordinator for Health Information Technology's (ONC)
regulatory certification structure and expand HIT certification, ONC
has proposed a voluntary 2015 Edition EHR Certification rule to more
easily accommodate HIT certification for technology used by other types
of health care settings where individual or institutional health care
providers are not typically eligible for incentive payments under the
EHR Incentive Programs, such as long-term and post-acute care and
behavioral health settings (79 FR 10880).
We believe that HIE and the use of certified EHRs by HHAs (and
other providers ineligible for the Medicare and Medicaid EHR Incentive
programs) can effectively and efficiently help providers improve
internal care delivery practices, support management of patient care
across the continuum, and enable the reporting of electronically
specified clinical quality measures (eCQMs). More information on the
identification of EHR certification criteria and development of
standards applicable to HH can be found at:
http://healthit.gov/policy-researchers-implementers/standards-and-certification-regulations
http://www.healthit.gov/facas/FACAS/health-it-policy-committee/hitpc-workgroups/certificationadoption
http://wiki.siframework.org/LCC+LTPAC+Care+Transition+SWG
http://wiki.siframework.org/Longitudinal+Coordination+of+Care

K. Proposed Revisions to the Speech-Language Pathologist Personnel
Qualifications

We propose to revise the personnel qualifications for speech-
language pathologists (SLP) to more closely align the regulatory
requirements with those set forth in section 1861(ll) of the Act. We
propose to require that a qualified SLP be an individual who has a
master's or doctoral degree in speech-language pathology, and who is
licensed as a speech-language pathologist by the State in which he or
she furnishes such services. To the extent of our knowledge, all states
license SLPs; therefore, all SLPs would be covered by this option. We
believe that deferring to the states to establish specific SLP
requirements would allow all appropriate SLPs to provide services to
Medicare beneficiaries. Should a state choose to not offer licensure at
some point in the future, we propose a second, more specific, option
for qualification. In that circumstance, we would require that an SLP
successfully complete 350 clock hours of supervised clinical practicum
(or is in the process of accumulating such supervised clinical
experience); perform not less than 9 months of supervised full-time
speech-language pathology services after obtaining a master's or
doctoral degree in speech-language pathology or a related field; and
successfully complete a national examination in speech-language
pathology approved by the Secretary. These specific requirements are
set forth in the Act, and we believe that they are appropriate for
inclusion in the regulations as well.
We invite comments on this technical correction and associated
change in the regulations at Sec. 484.4 in section VI.

L. Proposed Technical Regulations Text Changes

We propose to make technical corrections in Sec. 424.22(b)(1) to
better align the recertification requirements with the Medicare
Conditions of Participation (CoPs) for home health services.
Specifically, we propose that Sec. 424.22(b)(1) would specify that
recertification is required at least every 60 days when there is a need
for continuous home health care after an initial 60-day episode to
coincide with the CoP requirements in Sec. 484.55(d)(1), which require
the HHA to update the comprehensive assessment in the last 5 days of
every 60-day episode of care. As stated in Sec. 484.55, the
comprehensive assessment must identify the patient's continuing need
for home care and meet the patient's medical, nursing, rehabilitative,
social, and discharge planning needs. We also propose to specify in
Sec. 424.22(b)(1) that recertification is required at least every 60
days unless there is a beneficiary elected transfer or a discharge with
goals met and return to the same HHA

[[Page 38410]]

during the 60-day episode. The word ``unless'' was inadvertently left
out of the payment regulations text. Inserting ``unless'' into Sec.
424.22(b) (1) realigns the recertification requirements with the CoPs
at Sec. 484.55(d)(1).
As outlined in the ``Medicare Program; Prospective Payment System
for Home Health Agencies'' final rule published on July 3, 2000 (65 FR
41188 through 41190), a partial episode payment (PEP) adjustment
applies to two intervening events: (1) Where the beneficiary elects a
transfer to another HHA during a 60-day episode or the patient; or (2)
a discharge and return to the same HHA during the 60-day episode when a
beneficiary reached the treatment goals in the plan of care. To
discharge with goals met, the plan of care must be terminated with no
anticipated need for additional home health services for the balance of
the 60-day period. A PEP adjustment proportionally adjusts the
national, standardized 60-day episode payment amount to reflect the
length of time the beneficiary remained under the agency's care before
the intervening event.
We propose to revise Sec. 424.22(b)(1)(ii) to clarify that if a
beneficiary is discharged with goals met and/or no expectation of a
return to home health care and returns to the same HHA during the 60-
day episode a new start of care would be initiated (rather than an
update to the comprehensive assessment) and thus the second episode
would be considered a certification, not a recertification,\32\ and
would be subject to Sec. 424.22(a)(1).
---------------------------------------------------------------------------

\32\ http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/OASIS/downloads/OASISConsiderationsforPPS.pdf.
---------------------------------------------------------------------------

We also propose to make a technical correction in Sec.
484.250(a)(1) to remove the ``-C'' after ``OASIS'' in Sec.
484.250(a)(1), so that the regulation refers generically to the version
of OASIS currently approved by the Secretary, and to align this section
with the payment regulations at Sec. 484.210(e). Specifically, an HHA
must submit to CMS the OASIS data described at Sec. 484.55(b)(1) and
(d)(1) for CMS to administer the payment rate methodologies described
in Sec. 484.215, Sec. 484.230, and Sec. 484.235 and to meet the
quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.
We invite comments on these technical corrections and associated
changes in the regulations at Sec. 424.22 and Sec. 484.250 in section
VI.

M. Survey and Enforcement Requirements for Home Health Agencies

1. Statutory Background and Authority
Section 4023 of the Omnibus Budget Reconciliation Act of 1987 (OBRA
'87) (Pub. L 100-203, enacted on December 22, 1987) added subsections
1891(e) and (f) to the Act, which expanded the Secretary's options to
enforce federal requirements for home health agencies (HHAs or the
agency). Sections 1861(e)(1) and (2) of the Act provide that if CMS
determines that an HHA is not in compliance with the Medicare home
health Conditions of Participation and the deficiencies involved either
do or do not immediately jeopardize the health and safety of the
individuals to whom the agency furnishes items and services, then we
may terminate the provider agreement, impose an alternative
sanction(s), or both. Section 1891(f)(1)(B) of the Act authorizes the
Secretary to develop and implement appropriate procedures for appealing
determinations relating to the imposition of alternative sanctions.
In the November 8, 2012 Federal Register (77 FR 67068), we
published in the ``Alternative Sanctions for Home Health Agencies With
Deficiencies'' final rule (part 488, subpart J), as well as made
corresponding revisions to sections Sec. 489.53 and Sec. 498.3. This
subpart J added the rules for enforcement actions for HHAs including
alternative sanctions. Section 488.810(g) provides that 42 CFR part 498
applies when an HHA requests a hearing on a determination of
noncompliance that leads to the imposition of a sanction, including
termination. Section 488.845(b) describes the ranges of CMPs that may
be imposed for all condition-level findings: upper range ($8,500 to
$10,000); middle range ($1,500 to $8,500); lower range ($500 to
$4,000), as well as CMPs imposed per instance of noncompliance ($1,000
to $10,000).
Section 488.845(c)(2) addresses the appeals procedures when CMPs
are imposed, including the need for any appeal request to meet the
requirements of Sec. 498.40 and the option for waiver of a hearing.
2. Reviewability Pursuant to Appeals
We propose to amend Sec. 488.845 by adding a new paragraph (h)
which would explain the reviewability of a CMP that is imposed on a HHA
for noncompliance with federal participation requirements. The new
language will provide that when administrative law judges, state
hearing officers (or higher administrative review authorities) find
that the basis for imposing a civil money penalty exists, as specified
in Sec. 488.485, he or she may not set a penalty of zero or reduce a
penalty to zero; review the exercise of discretion by CMS or the state
to impose a civil money penalty; or, in reviewing the amount of the
penalty, consider any factors other than those specified in Sec.
488.485(b)(1)(i) through (b)(1)(iv). That is, when the administrative
law judge or state hearing officer (or higher administrative authority)
finds noncompliance supporting the imposition of the CMP, he or she
must retain some amount of penalty consistent with the ranges of
penalty amounts established in Sec. 488.845(b). The proposed language
for HHA reviews is similar to the current Sec. 488.438(e) governing
the scope of review for civil money penalties imposed against skilled
nursing facilities, and is also consistent with section 1128A(d) of the
Act which requires that specific factors be considered in determining
the amount of any penalty.
3. Technical Adjustment
We are also proposing to amend Sec. 498.3, Scope and
Applicability, by revising paragraph (b)(13) to include specific cross
reference to proposed Sec. 488.845(h) and to revise the reference to
section Sec. 488.740 which was a typographical error and replace it
with section Sec. 488.820 which is the actual section that lists the
sanctions available to be imposed against an HHA. We are also amending
Sec. 498.3(b)(14)(i) to include cross reference to proposed Sec.
488.845(h) which establishes the scope of CMP review for HHAs. Finally,
we are proposing to amend Sec. 498.60 to include specific references
to HHAs and proposed Sec. 488.845(h).

IV. Collection of Information Requirements

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. To
fairly evaluate whether an information collection 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

[[Page 38411]]

affected public, including automated collection techniques.
We are soliciting public comment the information collection
requirement (ICR) related to the proposed changes to the home health
face-to-face encounter requirements in section III.B and the proposed
change to the therapy reassessment timeframes in section III.H. These
proposed changes are associated with ICR approved under OMB control
number as 0938-1083.

A. Proposed Changes to the Face-to-Face Encounter Requirements

The following assumptions were used in estimating the burden for
the proposed changes to the home health face-to-face requirements:

Table 30--Home Health Face-to-Face Encounter Burden Estimate Assumptions
------------------------------------------------------------------------

------------------------------------------------------------------------
Number of Medicare-billing HHAs, from CY 11,521
2013 claims with matched OASIS
assessments..............................
Hourly rate of an office employee $20.54 ($15.80 x 1.30)
(Executive Secretaries and Executive
Administrative Assistants, 43-6014)......
Hourly rate of an administrator (General $64.65 ($49.73 x 1.30)
and Operations Managers, 11-1021)........
Hourly rate of Family and General $112.91 ($86.85 x 1.30)
Practitioners (29-1062)..................
------------------------------------------------------------------------
Note: CY = Calendar Year

All salary information is from the Bureau of Labor Statistics (BLS)
Web site at http://www.bls.gov/oes/current/naics4_621600.htm and
includes a fringe benefits package worth 30 percent of the base salary.
The mean hourly wage rates are based on May 2013 BLS data for each
discipline, for those providing ``home health care services.''
1. Proposed Changes to the Face-to-Face Encounter Narrative Requirement
Sections 1814(a)(2)(C) and 1835 (a)(2)(A) of the Act, as amended by
section 6407 of the Affordable Care Act require that, as a condition
for payment, prior to certifying a patient's eligibility for the
Medicare home health benefit the physician must document that the
physician himself or herself or an allowed nonphysician practitioner
(NPP) had a face-to-face encounter with the patient. Section
424.22(a)(1)(v) currently requires that the face-to-face encounter be
related to the primary reason the patient requires home health services
and occur no more than 90 days prior to the home health start of care
date or within 30 days after the start of the home health care. In
addition, as part of the certification of eligibility, the certifying
physician must document the date of the encounter and include an
explanation (narrative) of why the clinical findings of such encounter
support that the patient is homebound, as defined in section 1835(a) of
the Act, and in need of either intermittent skilled nursing services or
therapy services, as defined in Sec. 409.42(c).
To simplify the face-to-face encounter regulations, reduce burden
for HHAs and physicians, and to mitigate instances where physicians and
HHAs unintentionally fail to comply with certification requirements, we
propose to eliminate the narrative requirement at Sec.
424.22(a)(1)(v). The certifying physician will still be required to
certify that a face-to-face patient encounter, which is related to the
primary reason the patient requires home health services, occurred no
more than 90 days prior to the home health start of care date or within
30 days of the start of the home health care and was performed by a
physician or allowed non-physician practitioner as defined in Sec.
424.22(a)(1)(v)(A), and to document the date of the encounter as part
of the certification of eligibility.
In eliminating the face-to-face encounter narrative requirement, we
assume that there will be a one-time burden for the HHA to modify the
certification form, which the HHA provides to the certifying physician.
The revised certification form must allow the certifying physician to
certify that a face-to-face patient encounter, which is related to the
primary reason the patient requires home health services, occurred no
more than 90 days prior to the home health start of care date or within
30 days of the start of the home health care and was performed by a
physician or allowed NPP as defined in Sec. 424.22(a)(1)(v)(A). In
addition, the certification form must allow the certifying physician to
document the date that the face-to-face encounter occurred.
We estimate that it would take a home health clerical staff person
15 minutes (15/60 = 0.25 hours) to modify the certification form, and
the HHA administrator 15 minutes (15/60 = 0.25 hours) to review the
revised form. The clerical time plus administrator time equals a one-
time burden of 30 minutes or (30/60) = 0.50 hours per HHA. For all
11,521 HHAs, the total time required would be (0.50 x 11,521) = 5,761
hours. At $20.54 per hour for an office employee, the cost per HHA
would be (0.25 x $20.54) = $5.14. At $64.65 per hour for the
administrator's time, the cost per HHA would be (0.25 x $64.65) =
$16.16. Therefore, the total one-time cost per HHA would be $21.30, and
the total one-time cost for all HHAs would be ($21.30 x 11,521) =
$245,397.
In the CY 2011 HH PPS final rule (75 FR 70455), we estimated that
the certifying physician's burden for composing the face-to-face
encounter narrative, which includes how the clinical findings of the
encounter support eligibility (writing, typing, or dictating the face-
to-face encounter narrative) signing, and dating the patient's face-to-
face encounter, was 5 minutes for each certification (5/60 = 0.0833
hours). Because it has been our longstanding manual policy that
physicians sign and date certifications and recertifications, there is
no additional burden to physicians for signing and dating the face-to-
face encounter documentation. We estimate that there would be 3,096,680
initial home health episodes in a year based on 2012 claims data from
the home health Datalink file. As such, the estimated burden for the
certifying physician to write the face-to-face encounter narrative
would have been 0.0833 hours per certification (5/60 = 0.0833 hours) or
257,953 hours total (0.0833 hours x 3,096,680 initial home health
episodes). The estimated cost for the certifying physician to write the
face-to-face encounter narrative would have been $9.41 per
certification (0.0833 x $112.91) or $29,139,759 total ($9.41 x
3,096,680) for CY 2015.
Although we are proposing to eliminate the narrative, the
certifying physician will still be required to document the date of the
face-to-face encounter as part of the certification of eligibility. We
estimate that it would take no more than 1 minute for the certifying
physician to document the date that the face-to-face encounter occurred
(1/60 = 0.0166 hours). The estimated burden for the certifying
physician to continue to document the date of the face-to-face
encounter would be 0.0166 hours per certification or 51,405 hours total
(0.0166 hours x 3,096,680 initial home health episodes). The estimated
cost for the certifying physician to continue to document the date of
the face-to-face encounter would be $1.87 per certification (0.0166 x

[[Page 38412]]

$112.91) or $5,790,792 total ($1.87 x 3,096,680) for CY 2015.
Therefore, in eliminating the face-to-face encounter narrative
requirement, as proposed in section III.B. of this proposed rule, we
estimate that burden and costs will be reduced for certifying
physicians by 206,548 hours (257,953 - 51,405) and $23,348,967
($29,139,759 - $5,790,792), respectively for CY 2015.
2. Proposed Clarification on When Documentation of a Face-to-Face
Encounter is Required
To determine when documentation of a patient's face-to-face
encounter is required under sections 1814(a)(2)(C) and 1835 (a)(2)(A)
of the Act, we are proposing to clarify that the face-to-face encounter
requirement is applicable for certifications (not recertifications),
rather than initial episodes. A certification (versus recertification)
is generally considered to be any time that a new start of care OASIS
is completed to initiate care. We estimate that of the 6,562,856
episodes in the CY 2012 home health Datalink file, 3,096,680 start of
care assessments were performed on initial home health episodes. If
this proposal is implemented, an additional 830,287 episodes would
require documentation of a face-to-face encounter for subsequent
episodes that were initiated with a new start of care OASIS assessment.
We estimate that it would take no more than 1 minute for the certifying
physician to document the date that the face-to-face encounter occurred
(1/60 = 0.0166 hours). The estimated burden for the certifying
physician to document the date of the face-to-face encounter for each
certification (any time a new start of care OASIS is completed to
initiate care) would be 0.0166 hours or 13,783 total hours (0.0166
hours x 830,287 additional home health episodes). The estimated cost
for the certifying physician to document the date of the face-to-face
encounter for each additional home health episode would be $1.87 per
certification (0.0166 x $112.91) or $1,552,637 total ($1.87 x 830,287)
for CY 2015.

Table 31--Estimated One-Time Form Revision Burden for HHAs
--------------------------------------------------------------------------------------------------------------------------------------------------------
OMB No. Requirement HHAs Responses Hr. burden Total time Total dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
0938-1083............................ Sec. 11,521 1 0.5 hour................ 5,761 hours............ $245,397
424.22(a)(1)(v)
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 32--Estimated Burden Reduction for Certifying Physicians
[No Longer Drafting a Face-to-Face Encounter Narrative]
--------------------------------------------------------------------------------------------------------------------------------------------------------
OMB No. Requirement Certifications Responses Hr. burden Total time Total dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
0938-1083........................... Sec. 3,096,680 1 (0.0667) hour.......... (206,548) hours....... ($23,348,967)
424.22(a)(1)(v)
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 33--Estimated Burden for Certifying Physicians
[Documenting the Date of the Face-to-Face Encounter for Additional Certifications]
--------------------------------------------------------------------------------------------------------------------------------------------------------
OMB No. Requirement Certifications Responses Hr. burden Total time Total dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
0938-1083........................... Sec. 830,287 1 0.0166 hour............ 13,783 hours.......... $1,552,637
424.22(a)(1)(v)
--------------------------------------------------------------------------------------------------------------------------------------------------------

In summary, all of the proposed changes to the face-to-face
encounter requirements in section III.B of this proposed rule,
including changes to Sec. 424.22(a)(1)(v), will result in an estimated
net reduction in burden for certifying physicians of 192,765 hours or
$21,796,330 (see Tables 32 and 33). The proposed changes to the face-
to-face encounter requirements at Sec. 424.22(a)(1)(v) will result in
a one-time burden for HHAs to revise the certification form of 5,761
hours or $245,397 (Table 31).

B. Proposed Change to the Therapy Reassessment Timeframes

Currently, section 409.44(c) requires that patient's function must
be initially assessed and periodically reassessed by a qualified
therapist, of the corresponding discipline for the type of therapy
being provided, using a method which would include objective
measurement. If more than one discipline of therapy is being provided,
a qualified therapist from each of the disciplines must perform the
assessment and periodic reassessments. The measurement results and
corresponding effectiveness of the therapy, or lack thereof, must be
documented in the clinical record. At least every 30 days a qualified
therapist (instead of an assistant) must provide the needed therapy
service and functionally reassess the patient. If a patient is expected
to require 13 and/or 19 therapy visits, a qualified therapist (instead
of an assistant) must provide all of the therapy services on the 13th
visit and/or 19th therapy visit and functionally reassess the patient
in accordance with Sec. 409.44(c)(2)(i)(A). When the patient resides
in a rural area or if the patient is receiving multiple types of
therapy, a therapist from each discipline (not an assistant) must
assess the patient after the 10th therapy visit but no later than the
13th therapy visit and after the 16th therapy visit but no later than
the 19th therapy visit for the plan of care. In instances where the
frequency of a particular discipline, as ordered by a physician, does
not make it feasible for the reassessment to occur during the specified
timeframes without providing an extra unnecessary visit or delaying a
visit, then it is acceptable for the qualified therapist from that
discipline to provide all of the therapy and functionally reassess the
patient during the visit associated with that discipline that is
scheduled to occur closest to the 14th and/or 20th Medicare-covered
therapy visit, but no later than the 13th and/or 19th Medicare-covered
therapy visit. When a therapy reassessment is missed, any visits for
that discipline prior to the next reassessment are non-covered.

[[Page 38413]]

To lessen the burden on HHAs of counting visits and to reduce the
risk of noncovered visits so that therapists can focus more on
providing quality care for their patients, we propose to simplify Sec.
409.44(c) to require that therapy reassessments must be performed at
least once every 14 calendar days. The requirement to perform a therapy
reassessment at least once every 14 calendar days would apply to all
episodes regardless of the number of therapy visits provided. All other
requirements related to therapy reassessments would remain unchanged. A
qualified therapist (instead of an assistant), from each therapy
discipline provided, must provide the ordered therapy service and
functionally reassess the patient using a method which would include
objective measurement. The measurement results and corresponding
effectiveness of the therapy, or lack thereof, must be documented in
the clinical record.
In the CY 2011 HH PPS final rule we stated that the therapy
reassessment requirements in Sec. 409.44(c) are already part of the
home health CoPs, as well as from accepted standards of clinical
practice, and therefore, we believe that these requirements do not
create any additional burden on HHAs (75 FR 70454). As stated in the CY
2011 HH PPS final rule, longstanding CoP policy at Sec. 484.55
requires HHAs to document progress toward goals and the regulations at
Sec. 409.44(c)(2)(i) already mandate that for therapy services to be
covered in the home health setting, the services must be considered
under accepted practice to be a specific, safe, and effective treatment
for the beneficiary's condition. The functional assessment does not
require a special visit to the patient, but is conducted as part of a
regularly scheduled therapy visit. Functional assessments are necessary
to demonstrate progress (or the lack thereof) toward therapy goals, and
are already part of accepted standards of clinical practice, which
include assessing a patient's function on an ongoing basis as part of
each visit. The CY 2011 HH PPS final rule goes on to state that both
the functional assessment and its accompanying documentation are
already part of existing HHA practices and accepted standards of
clinical practice. Therefore, we continue to believe that changing the
required reassessment timeframes from every 30 days and prior to the
14th and 20th visits to every 14 calendar days does not place any new
documentation requirements on HHAs.
We are revising the currently approved PRA package (OMB
0938-1083) to describe these changes to the regulatory text.

C. Submission of PRA-Related Comments

If you comment on these information collection and recordkeeping
requirements, please submit your comments electronically as specified
in the ADDRESSES section of this proposed rule.
PRA-specific comments must be received on/by August 6, 2014.

V. 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.

VI. Regulatory Impact Analysis

A. Introduction

We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the
Unfunded Mandates Reform Act of 1995 (UMRA, March 22, 1995; Pub. L.
104-4), Executive Order 13132 on Federalism (August 4, 1999), and the
Congressional Review Act (5 U.S.C. 804(2)).
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 proposed rule has been designated as economically
significant under section 3(f)(1) of Executive Order 12866, since the
aggregate transfer impacts in calendar year 2015 will exceed the $100
million threshold. The net transfer impacts are estimated to be -$58
million. Furthermore, we estimate a net reduction of $21.55 million in
calendar year 2015 burden costs related to the certification
requirements for home health agencies and associated physicians.
Lastly, this proposed rule is a major rule under the Congressional
Review Act and as a result, we have prepared a regulatory impact
analysis (RIA) that, to the best of our ability, presents the costs and
benefits of the rulemaking. In accordance with the provisions of
Executive Order 12866, this regulation was reviewed by the Office of
Management and Budget.

B. Statement of Need

Section 1895(b)(1) of the Act requires the Secretary to establish a
HH PPS for all costs of HH services paid under Medicare. In addition,
section 1895(b)(3)(A) of the Act requires (1) the computation of a
standard prospective payment amount include all costs for HH services
covered and paid for on a reasonable cost basis and that such amounts
be initially based on the most recent audited cost report data
available to the Secretary, and (2) the standardized prospective
payment amount be adjusted to account for the effects of case-mix and
wage levels among HHAs. Section 1895(b)(3)(B) of the Act addresses the
annual update to the standard prospective payment amounts by the HH
applicable percentage increase. Section 1895(b)(4) of the Act governs
the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of
the Act require the standard prospective payment amount to be adjusted
for case-mix and geographic differences in wage levels. Section
1895(b)(4)(B) of the Act requires the establishment of appropriate
case-mix adjustment factors for significant variation in costs among
different units of services. Lastly, section 1895(b)(4)(C) of the Act
requires the establishment of wage adjustment factors that reflect the
relative level of wages, and wage-related costs applicable to HH
services furnished in a geographic area compared to the applicable
national average level.
Section 1895(b)(5) of the Act gives the Secretary the option to
make changes to the payment amount otherwise paid in the case of
outliers because of unusual variations in the type or amount of
medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires
HHAs to submit data for purposes of measuring health care quality, and
links the quality data submission to the annual applicable percentage
increase. Also, section 1886(d)(2)(D) of the Act requires that HH
services furnished in a rural area for episodes and visits ending on or
after April 1, 2010, and before January 1, 2016, receive an increase of
3 percent the payment amount

[[Page 38414]]

otherwise made under section 1895 of the Act.
Section 3131(a) of the Affordable Care Act mandates that starting
in CY 2014, the Secretary must apply an adjustment to the national,
standardized 60-day episode payment rate and other amounts applicable
under section 1895(b)(3)(A)(i)(III) of the Act to reflect factors such
as changes in the number of visits in an episode, the mix of services
in an episode, the level of intensity of services in an episode, the
average cost of providing care per episode, and other relevant factors.
In addition, section 3131(a) of the Affordable Care Act mandates that
rebasing must be phased-in over a 4-year period in equal increments,
not to exceed 3.5 percent of the amount (or amounts) as of the date of
enactment (2010) under section 1895(b)(3)(A)(i)(III) of the Act, and be
fully implemented in CY 2017.

C. Overall Impact

The update set forth in this rule applies to Medicare payments
under HH PPS in CY 2015. Accordingly, the following analysis describes
the impact in CY 2015 only. We estimate that the net impact of the
proposals in this rule is approximately $58 million in decreased
payments to HHAs in CY 2015. We applied a wage index budget neutrality
factor and a case-mix weights budget neutrality factor to the rates as
discussed in section III.D.4. of this proposed rule; therefore, the
estimated impact of the 2015 wage index proposed in section III.D.3. of
this proposed rule and the recalibration of the case-mix weights for
2015 proposed in section III.C. of this proposed rule is zero. The -$58
million impact reflects the distributional effects of the 2.2 percent
HH payment update percentage ($427 million increase) and the effects of
the second year of the four-year phase-in of the rebasing adjustments
to the national, standardized 60-day episode payment amount, the
national per-visit payment rates, and the NRS conversion factor for an
impact of -2.5 percent ($485 million decrease). The $58 million in
decreased payments is reflected in the last column of the first row in
Table 34 as a 0.3 percent decrease in expenditures when comparing CY
2014 payments to estimated CY 2015 payments.
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. Most hospitals and most other providers and
suppliers are small entities, either by nonprofit status or by having
revenues of less than $7.0 million to $35.5 million in any one year.
For the purposes of the RFA, we estimate that almost all HHAs are small
entities as that term is used in the RFA. Individuals and states are
not included in the definition of a small entity. The economic impact
assessment is based on estimated Medicare payments (revenues) and HHS's
practice in interpreting the RFA is to consider effects economically
``significant'' only if greater than 5 percent of providers reach a
threshold of 3 to 5 percent or more of total revenue or total costs.
The majority of HHAs' visits are Medicare-paid visits and therefore the
majority of HHAs' revenue consists of Medicare payments. Based on our
analysis, we conclude that the policies proposed in this rule will not
result in an estimated total impact of 3 to 5 percent or more on
Medicare revenue for greater than 5 percent of HHAs. Therefore, the
Secretary has determined that this proposed rule will not have a
significant economic impact on a substantial number of small entities.
Further detail is presented in Table 34, by HHA type and location.
Executive Order 13563 specifies, to the extent practicable,
agencies should assess the costs of cumulative regulations. However,
given potential utilization pattern changes, wage index changes,
changes to the market basket forecasts, and unknowns regarding future
policy changes, we believe it is neither practicable nor appropriate to
forecast the cumulative impact of the rebasing adjustments on Medicare
payments to HHAs for future years at this time. Changes to the Medicare
program may continue to be made as a result of the Affordable Care Act,
or new statutory provisions. Although these changes may not be specific
to the HH PPS, the nature of the Medicare program is such that the
changes may interact, and the complexity of the interaction of these
changes would make it difficult to predict accurately the full scope of
the impact upon HHAs for future years beyond CY 2015. We note that the
rebasing adjustments to the national, standardized 60-day episode
payment rate and the national per-visit rates are capped at the
statutory limit of 3.5 percent of the CY 2010 amounts (as described in
the preamble in section II.C. of this proposed rule) for each year,
2014 through 2017. The NRS rebasing adjustment will be -2.82 percent in
each year, 2014 through 2017.
In addition, section 1102(b) of the Act requires us to prepare a
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 603 of 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. This proposed rule applies to HHAs. Therefore, the
Secretary has determined that this rule will not have a significant
economic impact on the operations of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any one year of
$100 million in 1995 dollars, updated annually for inflation. In 2014,
that threshold is approximately $141 million. This proposed rule is not
anticipated to have an effect on state, local, or tribal governments in
the aggregate, or by the private sector, of $141 million or more in CY
2015.

D. Detailed Economic Analysis

This proposed rule sets forth updates for CY 2015 to the HH PPS
rates contained in the CY 2014 HH PPS final rule (78 FR 72304 through
72308). The impact analysis of this proposed rule presents the
estimated expenditure effects of policy changes proposed in this rule.
We use the latest data and best analysis available, but we do not make
adjustments for future changes in such variables as number of visits or
case-mix.
This analysis incorporates the latest estimates of growth in
service use and payments under the Medicare HH benefit, primarily on
preliminary Medicare claims from 2013. We note that certain events may
combine to limit the scope or accuracy of our impact analysis, because
such an analysis is future-oriented and, thus, susceptible to errors
resulting from other changes in the impact time period assessed. Some
examples of such possible events are newly-legislated general Medicare
program funding changes made by the Congress, or changes specifically
related to HHAs. In addition, changes to the Medicare program may
continue to be made as a result of the Affordable Care Act, or new
statutory provisions. Although these changes may not be specific to the
HH PPS, the nature of the Medicare program is such that the changes may
interact, and the complexity of the interaction of these changes could
make it difficult to predict accurately the full scope of the impact
upon HHAs.

[[Page 38415]]

Table 34 represents how HHA revenues are likely to be affected by
the policy changes proposed in this rule. For this analysis, we used an
analytic file with linked CY 2013 HH claims data (as of December 31,
2013) for dates of service that ended on or before December 31, 2013,
and OASIS assessments. The first column of Table 34 classifies HHAs
according to a number of characteristics including provider type,
geographic region, and urban and rural locations. The third column
shows the payment effects of proposed CY 2015 wage index. The fourth
column shows the payment effects of the proposed CY 2015 case-mix
weights. The fifth column shows the effects of the rebasing adjustments
to the national, standardized 60-day episode payment rate, the national
per-visit payment rates, and NRS conversion factor. The sixth column
shows the effects of the CY 2015 home health payment update percentage
(the home health market basket update adjusted for multifactor
productivity as discussed in section III.D.1. of this proposed rule).
The last column shows the payment effects of all the proposed policies.
Overall, HHAs are anticipated to experience a 0.3 percent decrease
in payment in CY 2015, with freestanding HHAs anticipated to experience
a 0.3 percent decrease in payments while facility-based HHAs and non-
profit HHAs are anticipated to experience a 0.4 percent and a 0.6
percent increase in payments, respectively. Government-owned HHAs are
anticipated to experience a 0.3 percent decrease in payments and
proprietary HHAs are anticipated to experience a 0.6 percent decrease
in payments. Rural HHAs are anticipated to experience a decrease in
payments of 0.5 percent with rural freestanding government-owned HHAs
and rural facility-based proprietary HHAs both estimated to experience
a -1.1 percent decrease in payments. In contrast, rural facility-based
non-profit HHAs are estimated to experience a 0.5 percent increase in
payments. Urban HHAs are anticipated to experience a decrease in
payments of 0.2 percent. Urban freestanding proprietary HHAs estimated
to experience a 0.5 percent decrease in payments, whereas urban
freestanding and facility-based non-profit HHAs are estimated to
experience a 0.6 percent increase in payments for CY 2015. The overall
impact in the South is estimated to be a 0.9 percent decrease in
payments whereas the overall impact in the North is estimated to be a
1.1 percent increase in payments. The West South Central census region
is estimated to receive a 2.4 percent decrease in payments for CY 2015;
however, in contrast, the New England census region is estimated to
receive a 1.5 percent increase in payments for CY 2015. Finally, HHAs
with less than 100 first episodes are anticipated to experience a 0.6
percent decrease in payments compared to a 0.00 percent decrease in
payments in CY 2015 for HHAs with 1,000 or more first episodes. A
substantial amount of the variation in the estimated impacts of the
proposals in this proposed rule in different areas of the country can
be attributed to variations in the CY 2015 wage index used to adjust
payments under the HH PPS and to the effects of the recalibration of
the case-mix weights. Instances where the impact, due to the rebasing
adjustments, is less than others can be attributed to differences in
the incidence of outlier payments and LUPA episodes, which are paid
using the national per-visit payment rates that are subject to payment
increases due to the rebasing adjustments. We note that some individual
HHAs within the same group may experience different impacts on payments
than others due to the distributional impact of the CY 2015 wage index,
the extent to which HHAs had episodes in case-mix groups where the
case-mix weight decreased for CY 2015 relative to CY 2014, and the
degree of Medicare utilization.
For CY 2015, the average impact for all HHAs due to the effects of
rebasing is an estimated 2.5 percent decrease in payments. The overall
impact for all HHAs as a result of this proposed rule is a decrease of
approximately 0.3 percent in estimated total payments from CY 2014 to
CY 2015.

Table 34--Estimated Home Health Agency Impacts by Facility Type and Area of the Country, CY 2015
----------------------------------------------------------------------------------------------------------------
CY 2015 HH
Proposed CY CY 2015 payment Impact of
Number of 2015 wage case-mix Rebasing update all CY 2015
agencies index \1\ weights \2\ \3\ percentage policies
(percent) (percent) (percent) \4\ (percent)
(percent)
----------------------------------------------------------------------------------------------------------------
All Agencies...................... 11,521 0.0 0.0 -2.5 2.2 -0.3
Facility Type and Control:
Free-Standing/Other Vol/NP.... 1,031 0.4 0.3 -2.3 2.2 0.6
Free-Standing/Other 8,957 -0.1 -0.1 -2.5 2.2 -0.6
Proprietary..................
Free-Standing/Other Government 398 0.1 -0.3 -2.4 2.2 -0.4
Facility-Based Vol/NP......... 788 0.2 0.6 -2.4 2.2 0.6
Facility-Based Proprietary.... 113 -0.4 0.5 -2.5 2.2 -0.2
Facility-Based Government..... 234 -0.1 0.2 -2.4 2.2 -0.2
-----------------------------------------------------------------------------
Subtotal: Freestanding.... 10,386 0.0 -0.1 -2.5 2.2 -0.3
Subtotal: Facility-based.. 1,135 0.2 0.5 -2.4 2.2 0.4
Subtotal: Vol/NP.......... 1,819 0.3 0.4 -2.4 2.2 0.6
Subtotal: Proprietary..... 9,070 -0.1 -0.1 -2.5 2.2 -0.6
Subtotal: Government...... 632 0.0 -0.1 -2.4 2.2 -0.3
Facility Type and Control: Rural:
Free-Standing/Other Vol/NP.... 193 -0.3 0.1 -2.4 2.2 -0.4
Free-Standing/Other 136 0.4 -0.1 -2.5 2.2 0.0
Proprietary..................
Free-Standing/Other Government 459 0.0 -0.9 -2.4 2.2 -1.1
Facility-Based Vol/NP......... 255 0.4 0.4 -2.5 2.2 0.5
Facility-Based Proprietary.... 31 0.0 -0.8 -2.5 2.2 -1.1
Facility-Based Government..... 138 0.1 -0.1 -2.4 2.2 -0.1
Facility Type and Control: Urban:
Free-Standing/Other Vol/NP.... 891 0.4 0.4 -2.3 2.2 0.6
Free-Standing/Other 8,644 -0.1 -0.1 -2.5 2.2 -0.5
Proprietary..................
Free-Standing/Other Government 158 0.3 -0.3 -2.5 2.2 -0.3
Facility-Based Vol/NP......... 533 0.2 0.6 -2.4 2.2 0.6

[[Page 38416]]

Facility-Based Proprietary.... 82 -0.5 0.7 -2.4 2.2 0.0
Facility-Based Government..... 96 -0.2 0.3 -2.5 2.2 -0.2
Facility Location: Urban or Rural: ........... ........... ........... ........... ........... 0.0
Rural......................... 1,117 0.1 -0.3 -2.4 2.2 -0.5
Urban......................... 10,404 -0.0 0.0 -2.5 2.2 -0.2
Facility Location: Region of the
Country:
North......................... 857 0.7 0.4 -2.2 2.2 1.1
Midwest....................... 3,095 -0.1 0.5 -2.5 2.2 0.1
South......................... 5,613 -0.3 -0.4 -2.5 2.2 -0.9
West.......................... 1,916 0.3 0.2 -2.4 2.2 0.3
Other......................... 40 0.2 -0.4 -2.5 2.2 -0.5
Facility Location: Region of the
Country (Census Region):
New England................... 336 1.1 0.5 -2.3 2.2 1.5
Mid Atlantic.................. 521 0.4 0.4 -2.2 2.2 0.8
East North Central............ 2,358 -0.1 0.4 -2.5 2.2 -0.1
West North Central............ 737 0.2 0.9 -2.5 2.2 0.8
South Atlantic................ 2,028 -0.3 1.1 -2.5 2.2 0.5
East South Central............ 438 -0.7 -0.3 -2.6 2.2 -1.4
West South Central............ 3,147 -0.2 -2.0 -2.5 2.2 -2.4
Mountain...................... 679 -0.1 0.9 -2.4 2.2 0.7
Pacific....................... 1,237 0.5 -0.1 -2.4 2.2 0.1
Facility Size (Number of 1st
Episodes):
<100 episodes................. 3,126 -0.2 -0.2 -2.5 2.2 -0.6
100 to 249.................... 2,879 -0.2 -0.2 -2.5 2.2 -0.7
250 to 499.................... 2,453 -0.2 -0.2 -2.5 2.2 -0.6
500 to 999.................... 1,725 -0.1 0.0 -2.5 2.2 -0.4
1,000 or More................. 1,338 0.1 0.1 -2.4 2.2 0.0
----------------------------------------------------------------------------------------------------------------
Source: CY 2013 Medicare claims data for episodes ending on or before December 31, 2013 (as of December 31,
2013) for which we had a linked OASIS assessment.
\1\ The impact of the proposed CY 2015 home health wage index reflects the transition to new CBSA designations
as outlined in section III.D.3 of this proposed rule offset by the wage index budget neutrality factor
described in section III.D.4 of this proposed rule.
\2\ The impact of the proposed CY 2015 home health case-mix weights reflects the recalibration of the case-mix
weights as outlined in section III.C of this proposed rule offset by the case-mix weights budget neutrality
factor described in section III.D.4 of this proposed rule.
\3\ The impact of rebasing includes the rebasing adjustments to the national, standardized 60-day episode
payment rate (-2.75 percent after the CY 2014 payment rate was adjusted for the wage index and case-mix weight
budget neutrality factors), the national per-visit rates (+3.26 percent), and the NRS conversion factor (-
2.82%). The estimated impact of the NRS conversion factor rebasing adjustment is an overall -0.01 percent
decrease in estimated payments to HHAs. The overall impact of all the rebasing adjustments finalized in the CY
2014 HH PPS proposed rule and implemented for CY 2015 are lower than the overall impact in the CY 2014 due to
an increase in estimated outlier payments. As the national per-visit rates increase and the national,
standardized 60-day episode rate decreases more episodes qualify for outlier payments. In addition, we
decreased the fixed-dollar loss (FDL) ratio from 0.67 to 0.45 effective CY 2013 in order to qualify more
episodes as outliers and we use CY 2013 utilization in simulating impacts for the CY 2015 HH PPS proposed
rule.
\4\ The CY 2015 home health payment update percentage reflects the home health market basket update of 2.6
percent, reduced by a 0.4 percentage point multifactor productivity (MFP) adjustment as required under section
1895(b)(3)(B)(vi)(I) of the Act, as described in section III.D.1 of this proposed rule.
REGION KEY:
New England = Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle Atlantic =
Pennsylvania, New Jersey, New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia,
Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central = Illinois, Indiana,
Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Tennessee; West North Central
= Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central = Arkansas,
Louisiana, Oklahoma, Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming;
Pacific = Alaska, California, Hawaii, Oregon, Washington; Outlying = Guam, Puerto Rico, Virgin Islands.

E. Alternatives Considered

In recalibrating the HH PPS case-mix weights for CY 2015, as
proposed in section III.C. of this proposed rule, we considered
adjusting the payment rates in section III.D.4 to make the
recalibration budget neutral only with regards to our estimate of real
case-mix growth between CY 2012 and the CY 2013. Section
1895(b)(3)(B)(iv) of the Act gives CMS the authority to implement
payment reductions for nominal case-mix growth--changes in case-mix
that are unrelated to actual changes in patient health status. If we
were to implement the recalibration of the case-mix weights outlined in
section III.C in a budget neutral manner only with regards to our
estimate of real case-mix growth between CY 2012 and CY 2013, we
estimate that the aggregate impact would be a net decrease of $410
million in payments to HHAs, resulting from a $485 million decrease due
to the second year of the Affordable Care Act mandated rebasing
adjustments, a $427 million increase due to the home health payment
update percentage, and a $350 million decrease (-1.8 percent) due to
only making the case-mix weights recalibration budget neutral with
regards to our estimate of real increases in patient severity. However,
instead of implementing a case-mix budget neutrality factor that only
reflects our estimate of real increases in patient severity; we plan to
recalibrate the case-mix weights in a fully budget-neutral manner and
continue to monitor case-

[[Page 38417]]

mix growth (both real and nominal case-mix growth) as more data become
available.
With regard to the proposal discussed in section III.D.3 of this
proposed rule related to our adoption of the revised OMB delineations
for purposes of calculating the wage index, we believe implementing the
new OMB delineations would result in wage index values being more
representative of the actual costs of labor in a given area. We
considered having no transition period and fully implementing the
proposed new OMB delineations beginning in CY 2015. This would mean
that we would adopt the revised OMB delineations on January 1, 2015.
However, this would not provide any time for HHAs to adapt to the new
OMB delineations. We believe that it would be appropriate to provide
for a transition period to mitigate the potential for resulting short-
term instability and negative impact on certain HHAs, and to provide
time for HHAs to adjust to their new labor market area delineations. In
determining an appropriate transition methodology, consistent with the
objectives set forth in the FY 2006 SNF PPS final rule (70 FR 45041),
we first considered transitioning the wage index to the revised OMB
delineations over a number of years in order minimize the impact of the
proposed wage index changes in a given year. However, we also believe
this must be balanced against the need to ensure the most accurate
payments possible, which argues for a faster transition to the revised
OMB delineations. We believe that using the most current OMB
delineations would increase the integrity of the HH PPS wage index by
creating a more accurate representation of geographic variation in wage
levels. As such, we believe that utilizing a one-year (rather than a
multiple year) transition with a blended wage index in CY 2015 would
strike the best balance. Second, we considered what type of blend would
be appropriate for purposes of the transition wage index. We are
proposing that HHAs would receive a one-year blended wage index using
50 percent of their CY 2015 wage index based on the proposed new OMB
delineations and 50 percent of their CY 2015 wage index based on the FY
2014 OMB delineations. We believe that a 50/50 blend would best
mitigate the negative payment impacts associated with the
implementation of the proposed new OMB delineations. While we
considered alternatives to the 50/50 blend, we believe this type of
split balances the increases and decreases in wage index values
associated with this proposal, as well as provides a readily
understandable calculation for HHAs.
Next, we considered whether or not the blended wage index should be
used for all HHAs or for only a subset of HHAs, such as those HHAs that
would experience a decrease in their respective wage index values due
to implementation of the revised OMB delineations. As required in
section 1895(b)(3) of the Act, the wage index adjustment must be
implemented in a budget-neutral manner. As such, if we were to apply
the transition policy only to those HHAs that would experience a
decrease in their respective wage index values due to implementation of
the revised OMB delineations, the wage index budget neutrality factor,
discussed in section III.D.4, would result in reduced base rates for
all HHAs as compared to the budget neutrality factor that results from
applying the blended wage index to all HHAs.
For the reasons discussed above, we believe that our proposal to
use a one-year transition with a blended wage index in CY 2015
appropriately balances the interests of all HHAs and would best achieve
our objective of providing relief to negatively impacted HHAs.
Section 3131(a) of the Affordable Care Act mandates that starting
in CY 2014, the Secretary must apply an adjustment to the national,
standardized 60-day episode payment rate and other amounts applicable
under section 1895(b)(3)(A)(i)(III) of the Act to reflect factors such
as changes in the number of visits in an episode, the mix of services
in an episode, the level of intensity of services in an episode, the
average cost of providing care per episode, and other relevant factors.
In addition, section 3131(a) of the Affordable Care Act mandates that
rebasing must be phased-in over a 4-year period in equal increments,
not to exceed 3.5 percent of the amount (or amounts) as of the date of
enactment (2010) under section 1895(b)(3)(A)(i)(III) of the Act, and be
fully implemented in CY 2017. Therefore, in the CY 2014 HH PPS final
rule (78 FR 77256), we finalized rebasing adjustments to the national,
standardized 60-day episode payment amount, the national per-visit
rates and the NRS conversion factor. As we noted in the CY 2014 HH PPS
final rule, because section 3131(a) of the Affordable Care Act requires
a four year phase-in of rebasing, in equal increments, to start in CY
2014 and be fully implemented in CY 2017, we do not have the discretion
to delay, change, or eliminate the rebasing adjustments once we have
determined that rebasing is necessary (78 FR 72283).
Section 1895(b)(3)(B) of the Act requires that the standard
prospective payment amounts for CY 2015 be increased by a factor equal
to the applicable HH market basket update for those HHAs that submit
quality data as required by the Secretary. For CY 2015, section 3401(e)
of the Affordable Care Act, requires that, in CY 2015 (and in
subsequent calendar years), the market basket update under the HHA
prospective payment system, as described in section 1895(b)(3)(B) of
the Act, be annually adjusted by changes in economy-wide productivity.
Beginning in CY 2015, section 1895(b)(3)(B)(vi)(I) of the Act, as
amended by section 3401(e) of the Affordable Care Act, requires the
application of the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act to the HHA PPS for CY 2015 and each
subsequent CY. The -0.4 percentage point productivity adjustment to the
proposed CY 2015 home health market basket update (2.6 percent), is
discussed in the preamble of this rule and is not discretionary as it
is a requirement in section 1895(b)(3)(B)(vi)(I) of the Act (as amended
by the Affordable Care Act).
We invite comments on the alternatives discussed in this analysis.

F. Accounting Statement and Table

As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars_a004_a-4), in Table 35, we have
prepared an accounting statement showing the classification of the
transfers and costs associated with the provisions of this proposed
rule. Table 35 provides our best estimate of the decrease in Medicare
payments under the HH PPS as a result of the changes presented in this
proposed rule. Table 35 also reflects the estimated change in costs and
burden for certifying physicians and HHAs as a result of the proposed
changes to the face-to-face encounter requirements in section III.B. We
estimate a net reduction in burden for certifying physicians of 192,765
hours or $21,796,330 (see section IV of this proposed rule). In
addition, Table 35 reflects our estimate of a one-time burden for HHAs
to revise the certification form of 5,761 hours or $245,397 as
described in section IV. of this proposed rule.

[[Page 38418]]

Table 35--Accounting Statement: Classification of Estimated Transfers
and Costs, From the CYs 2014 to 2015 *
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
Annualized Monetized Transfers. -$58 million.
From Whom to Whom?............. Federal Government to HHAs.
------------------------------------------------------------------------
Category Costs
------------------------------------------------------------------------
Annualized Monetized Net -$21.55 million.
Reduction in Burden for
Physicians Certifying Patient
Eligibility for Home Health
Services & HHAs for
Certification Form Revision.
------------------------------------------------------------------------
* The estimates reflect 2014 dollars.

G. Conclusion

In conclusion, we estimate that the net impact of the proposals in
this rule is a decrease in Medicare payments to HHAs of $58 million for
CY 2015. The $58 million decrease in estimated payments for CY 2015
reflects the distributional effects of the 2.2 percent CY 2015 HH
payment update percentage ($427 million increase) and the second year
of the 4-year phase-in of the rebasing adjustments required by section
3131(a) of the Affordable Care Act ($485 million decrease). Also,
starting in CY 2015, certifying physicians are estimated to incur a net
reduction in burden costs of $21,796,330 and HHAs are expected to incur
a one-time increase in burden costs to revise the certification form of
$245,397 as a result of the proposal to eliminate the face-to-face
encounter narrative requirement. This analysis, together with the
remainder of this preamble, provides an initial Regulatory Flexibility
Analysis.

VII. Federalism Analysis

Executive Order 13132 on Federalism (August 4, 1999) establishes
certain requirements that an agency must meet when it promulgates a
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.

List of Subjects

42 CFR Part 409

Health facilities, Medicare.

42 CFR Part 424

Emergency medical services, Health facilities, Health professions,
Medicare, and Reporting and recordkeeping requirements.

42 CFR Part 484

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

42 CFR Part 488

Administrative practice and procedure, Health facilities, Medicare,
and Reporting and recordkeeping requirements.

42 CFR Part 498

Health facilities, Medicare, Reporting and recordkeeping
requirements.

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

PART 409--HOSPITAL INSURANCE BENEFITS

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

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).

0
2. Section 409.44 is amended by--
0
A. Removing ``intermediary's'' from paragraph (a) and adding ``Medicare
Administrative Contractor's'' in its place.
0
B. Removing ``30'' from paragraph (c)(2)(i)(B) adding ``14 calendar''
in its place each time it appears.
0
C. Removing paragraphs (c)(2)(i)(C) and (D).
0
D. Redesignating paragraphs (c)(2)(i)(E) through (H) as paragraphs
(c)(2)(i)(C) through (F).
0
E. Removing ``(c)(2)(i)(A), (B), (C), and (D) of this section,'' from
newly redesignated paragraph (c)(2)(i)(C) introductory text and adding
``(c)(2)(i)(A) and (B) of this section,'' in its place.
0
F. Removing ``(c)(2)(i)(E)(2) and (c)(2)(i)(E)(3) of this section are
met,'' from newly redesignated paragraph (c)(2)(i)(C)(1) and adding
``(c)(2)(i)(C)(2) and (c)(2)(i)(C)(3) of this section are met,'' in its
place.
0
G. Removing ``Sec. 409.44(c)(2)(i)(H) of this section.'' from newly
redesignated paragraph (c)(2)(i)(C)(3) and adding ``Sec.
409.44(c)(2)(i)(F) of this section.'' in its place.

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
3. The authority citation for part 424 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).

0
4. Section 424.22 is amended by--
0
A. Revising paragraphs (a) and (b) and adding new paragraph (c).
0
B. Removing ``(d)(i)'' from paragraph (d)(2) and adding ``(d)(1)'' in
its place.
The revisions read as follows:

Sec. 424.22 Requirements for home health services.

* * * * *
(a) Certification--(1) Content of certification. As a condition for
payment of home health services under Medicare Part A or Medicare Part
B, a physician must certify the patient's eligibility for the home
health benefit, as outlined in 1814(a)(2)(C) and 1835(a)(2)(A) of the
Act, as follows in paragraphs (a)(1)(i) through (v) of this section.
The patient's medical record, as specified in paragraph (c) of this
section, must support the certification of eligibility as outlined in
paragraph (a)(1)(i) through (v) of this section.
(i) The individual needs or needed intermittent skilled nursing
care, or physical therapy or speech-language pathology services as
defined in Sec. 409.42(c) of this chapter. If a patient's underlying
condition or complication requires a registered nurse to ensure that
essential non-skilled care is achieving its purpose, and necessitates a
registered nurse be involved in the development, management, and
evaluation of a patient's care plan, the physician will include a brief
narrative describing the clinical justification of this need. If the
narrative is part of the certification form, then the narrative must be
located immediately prior to the physician's signature. If the
narrative exists as an addendum to the certification form, in

[[Page 38419]]

addition to the physician's signature on the certification form, the
physician must sign immediately following the narrative in the
addendum.
(ii) Home health services are or were required because the
individual is or was confined to the home, as defined in sections
1835(a) and 1814(a) of the Act, except when receiving outpatient
services.
(iii) A plan for furnishing the services has been established and
will be or was periodically reviewed by a physician who is a doctor of
medicine, osteopathy, or podiatric medicine, and who is not precluded
from performing this function under paragraph (d) of this section. (A
doctor of podiatric medicine may perform only plan of treatment
functions that are consistent with the functions he or she is
authorized to perform under State law.)
(iv) The services will be or were furnished while the individual
was under the care of a physician who is a doctor of medicine,
osteopathy, or podiatric medicine.
(v) A face-to-face patient encounter, which is related to the
primary reason the patient requires home health services, occurred no
more than 90 days prior to the home health start of care date or within
30 days of the start of the home health care and was performed by a
physician or allowed non-physician practitioner as defined in paragraph
(a)(1)(v)(A) of this section. The certifying physician must also
document the date of the encounter as part of the certification.
(A) The face-to-face encounter must be performed by one of the
following:
(1) The certifying physician himself or herself.
(2) A physician, with privileges, who cared for the patient in an
acute or post-acute care facility from which the patient was directly
admitted to home health.
(3) A nurse practitioner or a clinical nurse specialist (as those
terms are defined in section 1861(aa)(5) of the Act) who is working in
accordance with State law and in collaboration with the certifying
physician or in collaboration with an acute or post-acute care
physician with privileges who cared for the patient in the acute or
post-acute care facility from which the patient was directly admitted
to home health.
(4) A certified nurse midwife (as defined in section 1861(gg) of
the Act) as authorized by State law, under the supervision of the
certifying physician or under the supervision of an acute or post-acute
care physician with privileges who cared for the patient in the acute
or post-acute care facility from which the patient was directly
admitted to home health.
(5) A physician assistant (as defined in section 1861(aa)(5) of the
Act) under the supervision of the certifying physician or under the
supervision of an acute or post-acute care physician with privileges
who cared for the patient in the acute or post-acute care facility from
which the patient was directly admitted to home health.
(B) The face-to-face patient encounter may occur through
telehealth, in compliance with Section 1834(m) of the Act and subject
to the list of payable Medicare telehealth services established by the
applicable physician fee schedule regulation.
(1) Timing and signature. The certification of need for home health
services must be obtained at the time the plan of care is established
or as soon thereafter as possible and must be signed and dated by the
physician who establishes the plan.
(2) [Reserved]
(b) Recertification--(1) Timing and signature of recertification.
Recertification is required at least every 60 days when there is a need
for continuous home health care after an initial 60-day episode.
Recertification should occur at the time the plan of care is reviewed,
and must be signed and dated by the physician who reviews the plan of
care. Recertification is required at least every 60 days unless there
is a--
(i) Beneficiary elected transfer; or
(ii) Discharge with goals met and/or no expectation of a return to
home health care.
(2) Content and basis of recertification. The recertification
statement must indicate the continuing need for services and estimate
how much longer the services will be required. Need for occupational
therapy may be the basis for continuing services that were initiated
because the individual needed skilled nursing care or physical therapy
or speech therapy. If a patient's underlying condition or complication
requires a registered nurse to ensure that essential non-skilled care
is achieving its purpose, and necessitates a registered nurse be
involved in the development, management, and evaluation of a patient's
care plan, the physician will include a brief narrative describing the
clinical justification of this need. If the narrative is part of the
recertification form, then the narrative must be located immediately
prior to the physician's signature. If the narrative exists as an
addendum to the recertification form, in addition to the physician's
signature on the recertification form, the physician must sign
immediately following the narrative in the addendum.
(c) Determining patient eligibility for Medicare home health
services. In determining whether a patient is or was eligible to
receive services under the Medicare home health benefit at the start of
home health care, only the medical record for the patient from the
certifying physician or the acute/post-acute care facility (if the
patient in that setting was directly admitted to home health) used to
support the physician's certification of patient eligibility, as
described in paragraphs (a)(1) and (b) of this section, will be
reviewed. If the patient's medical record used in certifying
eligibility is not sufficient to demonstrate that the patient is or was
eligible to receive services under the Medicare home health benefit,
payment will not be rendered for home health services provided.
* * * * *

PART 484--HOME HEALTH SERVICES

0
5. The authority citation for part 484 continues to read as follows:

Authority: Secs 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)) unless otherwise indicated.

0
6. Section 484.4 is amended by revising the definition of ``speech-
language pathologist'' to read as follows:

Sec. 484.4 Personnel qualifications.

* * * * *
Speech-language pathologist. A person who has a master's or
doctoral degree in speech-language pathology, and who meets either of
the following requirements:
(a) Is licensed as a speech-language pathologist by the State in
which the individual furnishes such services; or
(b) In the case of an individual who furnishes services in a State
which does not license speech-language pathologists:
(1) Has successfully completed 350 clock hours of supervised
clinical practicum (or is in the process of accumulating such
supervised clinical experience);
(2) Performed not less than 9 months of supervised full-time
speech-language pathology services after obtaining a master's or
doctoral degree in speech-language pathology or a related field; and
(3) Successfully completed a national examination in speech-
language pathology approved by the Secretary.
0
7. Section 484.250 is amended by revising paragraph (a)(1) to read as
follows:

Sec. 484.250 Patient assessment data.

(a) * * *

[[Page 38420]]

(1) The OASIS data described at Sec. 484.55(b)(1) and (d)(1) of
this part for CMS to administer the payment rate methodologies
described in Sec. Sec. 484.215, 484.230, and 484.235 of this subpart,
and to meet the quality reporting requirements of section
1895(b)(3)(B)(v) of the Act.
* * * * *

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
8. The authority citation for part 488 continues to read as follows:

Authority: Secs. 1102, 1128I and 1871 of the Social Security
Act, unless otherwise noted (42 U.S.C. 1302, 1320a-7j, and 1395hh);
Pub. L. 110-149, 121 Stat. 1819.

0
9. Section 488.845 is amended by adding paragraph (h) to read as
follows:

Sec. 488.845 Civil money penalties.

* * * * *
(h) Review of the penalty. When an administrative law judge or
state hearing officer (or higher administrative review authority) finds
that the basis for imposing a civil monetary penalty exists, as
specified in this part, the administrative law judge, State hearing
officer (or higher administrative review authority) may not--
(1) Set a penalty of zero or reduce a penalty to zero;
(2) Review the exercise of discretion by CMS to impose a civil
monetary penalty; and
(3) Consider any factors in reviewing the amount of the penalty
other than those specified in paragraph (b) of this section.

PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT
AFFECT THE PARTCIPATION OF ICFS/IID AND CERTAIN NFS IN THE MEDICAID
PROGRAM

0
10. The authority citation for part 498 continues to read as follows:

Authority: Secs. 1102, 1128I and 1871 of the Social Security Act
(42 U.S.C. 1302, 1320a-7j, and 1395hh).

0
11. Section 498.3 is amended by revising paragraphs (b)(13) and
(b)(14)(i) to read as follows:

Sec. 498.3 Scope and applicability.

* * * * *
(b) * * *
(13) Except as provided at paragraph (d)(12) of this section for
SNFs, NFs and HHAs, the finding of noncompliance leading to the
imposition of enforcement actions specified in Sec. 488.406 or Sec.
488.820 of this chapter, but not the determination as to which sanction
was imposed. The scope of review on the imposition if a civil money
penalty is specified in Sec. 488.438(e) and Sec. 488.845(h) of this
chapter.
(14) * * *
(i) The range of civil money penalty amounts that CMS could collect
(for SNFs or NFs, the scope of review during a hearing on the
imposition of a civil money penalty is set forth in Sec. 488.438(e) of
this chapter and for HHAs, the scope of review during a hearing on the
imposition of a civil money penalty is set forth in Sec. 488.845(h) of
this chapter); or
* * * * *
0
12. Section 498.60 is amended by revising paragraphs (c)(1) and (c)(2)
to read as follows:

Sec. 498.60 Conduct of hearing.

* * * * *
(c) * * *
(1) The scope of review is as specified in Sec. 488.438(e) and
Sec. 488.845(h) of this chapter; and
(2) CMS' determination as to the level of noncompliance of a SNF,
NF or HHA must be upheld unless it is clearly erroneous.

Dated: June 16, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
Approved: June 19, 2014.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2014-15736 Filed 7-1-14; 4:15 pm]
BILLING CODE 4120-01-P