Federal Register, Volume 82 Issue 9 (Friday, January 13, 2017)

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Rules and Regulations]
[Pages 4504-4591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00283]

[[Page 4503]]

Vol. 82

Friday,

No. 9

January 13, 2017

Part III

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 409, 410, 418, et al.

Medicare and Medicaid Program: Conditions of Participation for Home
Health Agencies; Final Rule

Federal Register / Vol. 82 , No. 9 / Friday, January 13, 2017 / Rules
and Regulations

[[Page 4504]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 410, 418, 440, 484, 485 and 488

[CMS-3819-F]
RIN 0938-AG81

Medicare and Medicaid Program: Conditions of Participation for
Home Health Agencies

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

ACTION: Final rule.

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SUMMARY: This final rule revises the conditions of participation (CoPs)
that home health agencies (HHAs) must meet in order to participate in
the Medicare and Medicaid programs. The requirements focus on the care
delivered to patients by HHAs, reflect an interdisciplinary view of
patient care, allow HHAs greater flexibility in meeting quality care
standards, and eliminate unnecessary procedural requirements. These
changes are an integral part of our overall effort to achieve broad-
based, measurable improvements in the quality of care furnished through
the Medicare and Medicaid programs, while at the same time eliminating
unnecessary procedural burdens on providers.

DATES: These regulations are effective on July 13, 2017.

FOR FURTHER INFORMATION CONTACT:
Danielle Shearer (410) 786-6617.
Mary Rossi-Coajou (410) 786-6051.
Maria Hammel (410) 786-1775.

SUPPLEMENTARY INFORMATION:

I. Background Information

A. The Home Health Benefit

Home health services are covered for the elderly and disabled under
the Hospital Insurance (Part A) and Supplemental Medical Insurance
(Part B) benefits of the Medicare program, and are described in section
1861(m) of the Social Security Act (the Act). These services, provided
under a plan of care that is established and periodically reviewed by a
physician, must be furnished by, or under arrangement with, a home
health agency (HHA) that participates in the Medicare or Medicaid
programs. Services are provided on a visiting basis in the
beneficiary's home, and may include the following:
Part-time or intermittent skilled nursing care furnished
by or under the supervision of a registered professional nurse.
Physical therapy, speech-language pathology, and
occupational therapy.
Medical social services under the direction of a
physician.
Part-time or intermittent home health aide services.
Medical supplies (other than drugs and biologicals) and
durable medical equipment.
Services of interns and residents if the HHA is owned by
or affiliated with a hospital that has an approved medical residency
training program.
Services at hospitals, skilled nursing facilities, or
rehabilitation centers when the services involve equipment too
cumbersome to bring to the home.
Under the authority of sections 1861(o) and 1891 of the Act, the
Secretary has established in regulations the requirements that an HHA
must meet to participate in the Medicare program. These requirements
are set forth in regulations at 42 CFR part 484, Home Health Services.
Current regulations at 42 CFR 440.70(d) specify that HHAs participating
in the Medicaid program must also meet the Medicare Conditions of
Participation (CoPs). Section 1861(o)(6) of the Act requires that an
HHA must meet the CoPs specified in section 1891(a) of the Act, and
other CoPs as the Secretary finds necessary in the interest of the
health and safety of patients. Section 1891(a) of the Act establishes
specific requirements for HHAs in several areas, including patient
rights, home health aide training and competency, and compliance with
applicable federal, state, and local laws. The CoPs for HHAs protect
all individuals under the HHA's care, unless a requirement is
specifically limited to Medicare beneficiaries. Section 1861(o) of the
Act describes an HHA for purposes of participation in the Medicare
program. All the requirements are stated generally, and are applicable
to the HHA's overall activity, not specifically to Medicare patients.
This provision, which was reaffirmed by the Congress in the Omnibus
Budget Reconciliation Act (OBRA), 1987 amendments to section 1891(a) of
the Act, has been in the law since the inception of the Medicare
program, and CMS' interpretation of it has remained the same. Under
section 1891(b) of the Act, the Secretary is responsible for assuring
that the CoPs, and their enforcement, are adequate to protect the
health and safety of individuals under the care of an HHA, and to
promote the effective and efficient use of Medicare funds. To implement
this requirement, State Survey Agencies and CMS-approved accrediting
organizations conduct surveys of HHAs to determine whether they are
complying with the CoPs.

B. Previous HHA Conditions of Participation Rules

On March 10, 1997 (62 FR 11004), we published a proposed rule,
entitled, ``Revision of the Conditions of Participation for Home Health
Agencies and Use of the Outcome and Assessment Information Set (OASIS)
as Part of the Revised Conditions of Participation for Home Health
Agencies,'' that would have revised the entire set of HHA CoPs. Due to
the significant volume of public comments and the rapidly changing
nature of the HHA industry at that time, this rule, in its entirety,
was never finalized.
Rather than finalizing all portions of the March 1997 rule, we
published a final regulation (64 FR 3764, January 25, 1999) that only
finalized the OASIS regulations. The January 1999 final rule required
that each patient receive from the HHA a patient-specific,
comprehensive assessment that identifies the patient's medical,
nursing, rehabilitation, social, and discharge planning needs.
We also issued an interim final rule with comment period on the
same day (64 FR 3748) that required HHAs to use the OASIS data
collection instrument that standardizes parts of the assessment and to
transmit the data to CMS. That rule implemented sections 1891(c)(2)(C)
and 1891(d)(1) of the Act, which require the Secretary to establish a
standardized assessment instrument for measuring the quality of care
and services furnished by HHAs. The OASIS data collection instrument
and data transmission rule was finalized on December 23, 2005 (70 FR
76199).
Although the OASIS requirements were finalized in separate rules,
we intended to proceed with another rule to finalize the remainder of
the requirements of the March 1997 proposed rule. However, section 902
of the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (MMA) added section 1871(a)(3) to the Act. This section
provided that, effective December 8, 2003, the Secretary, in
consultation with the Director of the Office of Management and Budget
(OMB), would have to establish and publish regular timelines for the
publication of Medicare proposed regulations based on the previous
publication of Medicare proposed or interim final regulations. Section
902 of the MMA further provided that the timeline could vary among
different regulations, but could

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not be longer than 3 years, except under exceptional circumstances.
Pursuant to the MMA, we issued a notice implementing this provision in
the Federal Register on December 30, 2004 (69 FR 78442). In that
notice, we interpreted section 902 as rendering ineffective any
proposed Medicare regulations that had been outstanding for 3 years or
more as of December 8, 2003; this included the proposed HHA CoPs.
Therefore, out of an abundance of caution, we decided not to finalize
the remaining provisions of the March 10, 1997 proposed rule, but begin
rulemaking again.
On October 9, 2014, we set forth proposed rules for HHAs that
choose to participate in Medicare and Medicaid (79 FR 61164). We
proposed to revise all of the existing CoPs, and to add several new
CoPs to address aspects of home health care that we believe need
attention.

C. Transforming the HHA Conditions of Participation

As the single largest payer for health care services in the United
States, the Federal government assumes a critical responsibility for
the delivery and quality of care furnished under its programs.
Historically, we have adopted a quality assurance approach that has
been directed toward identifying health care providers that furnish
poor quality care or fail to meet minimum Federal standards. Facilities
not meeting requirements would either correct the inappropriate
practice(s) or would be terminated from participation in the Medicare
or Medicaid programs. We have found that this problem-focused approach
has inherent limits. Ensuring quality through the enforcement of
prescriptive health and safety standards, rather than improving the
quality of care for all patients, has resulted in expending much of our
resources on dealing with marginal providers, rather than on
stimulating broad-based improvements in the quality of care delivered
to all patients.
Obtaining quality health care for Federal beneficiaries from CMS-
certified providers and suppliers requires taking advantage of
continuing advances in the health care delivery field. As a result, we
are revising the home health agency requirements to focus on a patient-
centered, data-driven, outcome-oriented process that promotes high
quality patient care at all times for all patients. Before we began
development of new proposed CoPs for Medicare and Medicaid
participating HHAs, we received recommendations from home health
providers, professional associations and practitioner communities,
consumer advocates and state and other governmental agencies with an
interest or responsibility in HHA regulation and oversight. We also
took into account the comments that were submitted by the public on the
March 1997 proposed rule and suggestions submitted by the HHA industry
in the summer of 2011, as well as developments since that time within
the industry. In light of this information, we have used the following
principles to assist in the development of the new HHA CoPs:
[ssquf] Develop a more continuous, integrated care process across
all aspects of home health services, based on a patient-centered
assessment, care planning, service delivery, and quality assessment and
performance improvement.
[ssquf] Use a patient-centered, interdisciplinary approach that
recognizes the contributions of various skilled professionals and their
interactions with each other to meet the patient's needs. Stress
quality improvements by incorporating an outcome-oriented, data-driven,
quality assessment and performance improvement program specific to each
HHA.
[ssquf] Eliminate the focus on administrative process requirements
that lack adequate consensus or evidence that they are predictive of
either achieving clinically relevant outcomes for patients or
preventing harmful outcomes for patients.
[ssquf] Safeguard patient rights.
We believe that the overall approach of the CoPs provides HHAs with
greatly enhanced flexibility. At the same time, we believe the new
requirements improve performance results for HHAs, in terms of
achieving needed and desired outcomes for patients, and increasing
patient satisfaction with services provided.

D. Organization of This Rule

This final rule is organized in the following manner:
Background Information. This section summarizes the Home
Health benefit, previous HHA CoP rules, and transforming the HHA CoP.
Provisions of the Proposed Regulations. This section
briefly summarizes all of the proposed requirements in numerical order
by CoP number.
Home Health Crosswalk. This section cross references
former requirements to their new location.
Analysis of and Responses to Public Comments. This section
summarizes and responds to all public comments that were received in
numerical order by CoP number.
Provisions of the Final Rule. This section lists all
changes that were made from the proposed version of the rule to the
final version of the rule.
Good Cause to Waive Notice and Comment Rulemaking. This
section explains why notice-and-comment is impracticable, unnecessary,
or contrary to the public interest.
Collection of Information and Regulatory Impact Analysis.
These sections describe the anticipated estimated burdens and savings
that will result from the implementation of this final rule in a
statistically typical HHA.
Regulatory Text. This section sets forth the regulations
that are being finalized in this rule.

II. Provisions of the Proposed Regulations

A. Overview

We proposed to make extensive changes in the organizational scheme
to group together all CoPs directly related to patient care and place
them near the beginning of part 484. Regulations concerning the
organization and administration of an HHA would follow in a separate
subpart entitled ``Organizational Environment.''

B. Proposed Subpart A, General Provisions

We proposed to reorganize this section to clarify the basis and
scope of this part. Part 484 is based on sections 1861(o) and 1891 of
the Act, which establish the conditions that an HHA must meet in order
to participate in the Medicare program. Part 484 is also based on
section 1861(z) of the Act, which specifies the institutional planning
standards that HHAs must meet. These provisions serve as the basis for
survey activities for the purposes of determining whether an agency
meets the requirements for participation in Medicare.
At Sec. 484.2, we proposed to clarify some of the definitions for
terms used in the HHA CoPs. We proposed to modify the definition for
``branch office'' by adding the requirement that the parent agency
offer more than the sharing of services; specifically, that it provide
supervision and administrative control of branches on a daily basis to
the extent that the branch depends upon the parent agency's supervision
and administrative functions in order to meet the CoPs, and could not
do so as an independent entity. Though the definition would no longer
require the branch office to be ``sufficiently close,'' the parent
agency would have to be

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available to meet the needs of any situation and respond to issues that
could arise with respect to patient care or administration of the
agency. A violation of a CoP in one branch office would apply to the
entire HHA.
We also proposed minor changes in the language of the current
definitions for ``clinical note,'' ``parent home health agency,''
``proprietary agency,'' and ``subdivision.'' We also proposed to
eliminate current definitions of the terms ``bylaws'' and
``supervision,'' ``home health agency,'' ``progress notes,'' and
``subunit.'' On the effective date of this rule, any existing subunits,
which already operate under their own provider number, will be
considered distinct HHAs and will be required to independently meet all
CoPs, including having an independent governing body and administrator.
Subject to state-specific laws and regulations, this federal regulatory
change will permit a subunit to apply to become a branch of its
existing parent HHA if the parent provides ``. . . direct support and
administrative control'' of the branch. The State Survey Agency and CMS
Regional Office will continue to be responsible for approving an HHA's
application for a branch office, in accordance with current CMS
guidance as set out in various survey and certification letters and
section 2182.4B of the State Operations Manual. No new subunits will be
approved upon implementation of this regulation, only ``branch
offices.''
Finally, we proposed to add definitions for the terms ``in
advance,'' ``quality indicator,'' ``representative,'' ``supervised
practical training,'' and ``verbal order.'' We proposed to define the
term ``representative'' in a patient-centered manner that enables
patients to choose their representatives, if they wish to do so. We
proposed to define the term ``verbal orders'' to mean those physician
orders that are delivered verbally (meaning spoken), by the physician,
to a nurse or other qualified medical personnel, and recorded in the
plan of care.
As discussed in detail in section III.D.4 of this preamble, we
proposed modifications to the current personnel qualifications
requirements, and proposed to relocate those requirements to Sec.
484.80, ``Home health aide services,'' and Sec. 484.115, ``Personnel
qualifications.''
We also proposed to retain the current definitions of ``primary
home health agency,'' ``public agency,'' and ``summary report'' without
change.

C. Proposed Subpart B, Patient Care

1. Release of Patient Identifiable OASIS Information (Proposed Sec.
484.40)
At Sec. 484.40, we proposed to recodify the current requirements
of Sec. 484.11, which require an HHA and its agents to ensure the
confidentiality of all patient-identifiable information in the clinical
record, including the OASIS data.
2. Reporting OASIS Information (Proposed Sec. 484.45)
In this CoP, we proposed to include most of the current
requirements of Sec. 484.20, which relate to the electronic reporting
of the OASIS data. We proposed to remove the requirement that an HHA
transmit data using electronic communications software that provides a
direct telephone connection from the HHA to the state agency or CMS
OASIS contractor. In its place, we proposed to add a requirement that
the OASIS data be transmitted in accordance with current CMS
transmission policy, which currently requires HHAs to transmit data
using electronic communications software that complies with the Federal
Information Processing Standard (FIPS 140-2, issued May 25, 2001).
3. Patient Rights (Proposed Sec. 484.50)
At Sec. 484.50, we proposed revised patient rights provisions
under six standards: (1) Notice of rights; (2) Exercise of rights; (3)
Rights of the patient; (4) Transfer and discharge; (5) Investigation of
complaints; and (6) Accessibility. In proposed Sec. 484.50(a), we
stated that each patient and patient representative (if the patient has
one), would have the right to be informed of his or her rights in a
language and manner the individual understands.
More specifically, under Sec. 484.50(a)(1), we proposed that the
HHA provide the patient and patient's representative with verbal notice
of the patient's rights in the primary or preferred language of the
patient or representative, and in a manner that the individual can
understand, during the initial evaluation visit, and in advance of care
being furnished by the HHA. We also proposed to require that the
patient be provided a written copy of the patient rights information.
The written information would be required to be provided in alternate
formats free of charge for persons with disabilities, when necessary,
to ensure effective communication. In addition, written notice would be
required to be understandable to persons who had limited English
proficiency. Furthermore, HHAs would be required to inform patients of
the availability of the services and instruct patients how to access
those services.
Proposed Sec. 484.50(a) (2) would require the HHA to provide each
patient with specific business contact information for the HHA's
administrator so that patients and caregivers could report complaints
and specific patient rights violations to the HHA administrator, and
could ask questions about the care being provided. We also proposed at
Sec. 484.50(a)(3) that the HHA provide a copy of the OASIS privacy
notice to all patients from whom the OASIS data are collected at the
same time that the general notice of rights is provided to the patient.
Finally, at Sec. 484.50(a)(4), we proposed to require that the HHA
obtain the patient's or representative's signature confirming that he
or she received a copy of the notice of rights and responsibilities.
At Sec. 484.50(b), ``Exercise of rights,'' we proposed that, in
the event that a patient was declared incompetent under state law by a
court of proper jurisdiction, the rights of that patient could be
exercised by the person appointed by the state court. If a state court
had not made a declaration, any representative, as chosen by the
patient, could exercise the rights of the patient in accordance with
the patient's preferences. In situations where a patient has been
adjudged to lack legal capacity under state law by a court of proper
jurisdiction, the patient would be allowed to exercise his or her
rights to the extent allowed by the court order.
Proposed Sec. 484.50(c) set forth the explicit rights of each home
health patient. At Sec. 484.50(c) (1), we proposed that the patient
would have a right to have his or her property and person treated with
respect. At Sec. 484.50(c) (2), we proposed that the patient would
have a right to be free from verbal, mental, sexual and physical abuse,
including injuries of unknown source, neglect, and misappropriation of
property. Under proposed Sec. 484.50(c)(3), the patient would have a
right to make complaints to the HHA regarding treatment or care that
was (or failed to be) furnished which the patient and/or their family
believe was inappropriate. Under proposed Sec. 484.50(c)(4), patients
and their representatives would also have the right to participate in,
be informed about, and consent to or refuse care. Moreover, each
patient would have the right to participate in and be informed about
the patient-specific comprehensive assessment, including an assessment
of the patient's goals and care preferences. Additionally, each patient
would have the right to participate in and be informed about the care
that the HHA plans to furnish

[[Page 4507]]

based on the needs identified during the comprehensive assessment,
establishing and revising that plan, the disciplines that will furnish
care, the frequency of visits, identifying expected outcomes of care,
and any factors that could impact treatment effectiveness. In
accordance with proposed Sec. 484.50(c)(4)(iii), each patient would
also have the right to receive a copy of his or her individualized HHA
plan of care, including all updated plans of care, as described in
proposed Sec. 484.60. HHAs would be required at Sec.
484.50(c)(4)(viii) to inform the patient about any changes in the care
to be furnished in advance of those changes being made in the patient's
plan of care. In addition to being involved in the care planning
process, we proposed to add a requirement at Sec. 484.50(c)(5) that
patients have the right to receive all of the services outlined in the
plan of care. Additionally, we proposed to retain the current
requirements from current Sec. 484.10(d), which concern the patient's
right to the confidentiality of his or her clinical records, under
proposed Sec. 484.50(c)(6). Proposed Sec. 484.50(c)(7) would retain
the requirements of the current standard at Sec. 484.10(e), Patient
liability for payment. This patient liability requirement would be
related to the home health advance beneficiary notice (ABN) and home
health change of care notices; therefore, we proposed to reference the
current requirements at Sec. 411.408(d)(2) and Sec. 411.408(f). HHAs
would be required to comply with all ABN requirements, including
restrictions related to who may receive the ABN on the patient's
behalf.
At Sec. 484.50(c)(8), we proposed that a patient would have the
right to receive proper written notice, in advance of a specific
service being furnished, if the HHA believes that the service may be
non-covered care; or in advance of the HHA reducing or terminating on-
going care. We proposed to incorporate a cross-reference to the
regulations regarding expedited reviews, found at 42 CFR part 405,
subpart J.
We proposed to retain the current regulations regarding the home
health hotline at proposed Sec. 484.50(c)(9). Patients would be
advised that the purpose of the hotline was to receive complaints or
questions about local HHAs. Additionally, under Sec. 484.50(c)(10),
patients would be advised of the names, addresses, and telephone
numbers for relevant federally and state-funded consumer information,
consumer protection, and advocacy agencies.
We also proposed at Sec. 484.50(c)(11), that patients have the
right to be free from discrimination or reprisal for exercising their
rights, whether by voicing grievances to the HHA or to an outside
entity. Finally, we proposed at Sec. 484.50(c)(12) that patients have
the right to be informed of their right to access auxiliary aids and
language services, and to be provided instruction on how to access
these services.
We proposed to add a new standard at Sec. 484.50(d), which would
mandate that all patients and representatives (if any), have the right
to be informed of the HHA's policies governing admission, transfer, and
discharge in advance of the HHA providing care. This proposed standard
set forth the criteria by which an HHA could discharge or transfer a
patient. Under this proposed standard, an HHA could only transfer,
discharge, or terminate care for the following reasons: (1) If the
physician responsible for the HHA plan of care and HHA agreed that the
HHA could no longer meet the patient's needs, based on the patient's
acuity; (2) when the patient or payer could no longer pay for the
services provided by the HHA; (3) if the physician responsible for the
HHA plan of care and HHA agreed that the patient no longer needed HHA
services because the patient's health and safety had improved or
stabilized sufficiently; (4) when the patient refused HHA services or
otherwise elected to be transferred or discharged (including if the
patient elected the Medicare hospice benefit); (5) when there was
cause; (6) when a patient died; or (7) when the HHA ceased to operate.
In accordance with the requirements of proposed Sec. 484.50(d)(1),
if the care needs of a patient exceeded the HHA's ability to provide
services, the HHA would be required to ensure that the patient received
a safe and appropriate transfer to another care entity better suited to
meeting the patient's needs.
We proposed to specify at Sec. 484.50(d)(5) that we would permit
discharge for cause if the patient's (or other persons in the patient's
home) behavior was so disruptive, abusive, or uncooperative that the
delivery of care to the patient or the ability of the HHA to operate
effectively and safely was seriously impaired. Before discharging a
patient for cause, the HHA would be required to advise the patient, the
representative (if any), the physician who was responsible for the home
health plan of care, and the patient's primary care practitioner or
other health care professional who would be responsible for providing
care and services to the patient after discharge from the HHA (if any)
that a discharge for cause was being considered, make efforts to
resolve the problem(s) presented by the patient's behavior or by other
person(s) in the home (as applicable), or situation (such as a
dangerous animal being loose in the home), document the problem(s) and
efforts made to resolve the problem(s), and enter this documentation
into its clinical records. Additionally, we proposed that the HHA would
be required to provide the patient and representative (if any), with
contact information for other agencies or providers who were
potentially able to provide care following the discharge.
Given the vulnerability of home health patients and in the interest
of patient safety, we proposed a standard at Sec. 484.50(e),
``Investigation of complaints,'' that would require the HHA to
investigate complaints made by patients, representatives, caregivers,
and families regarding treatment or care that was (or failed to be)
furnished, or was furnished inconsistently or inappropriately. In
addition, HHAs would be required to investigate allegations of
mistreatment, neglect, or verbal, mental, psychosocial, sexual, and
physical abuse, including injuries of unknown source, and
misappropriation of patient property by anyone furnishing services on
behalf of the HHA. Proposed Sec. 484.50(e)(1)(ii) would require the
HHA to document both the existence and the resolution of the complaint,
while Sec. 484.50(e)(1)(iii) would require the HHA to take immediate
action to prevent further potential abuse while the complaint was being
investigated.
Proposed Sec. 484.50(e)(2) would require any HHA staff, regardless
of whether they are employed directly or obtained under arrangements
with another entity, to immediately report to the HHA or other
appropriate authorities any incidences of mistreatment, neglect, or
abuse, and/or any misappropriation of patient property, which they have
noticed during the normal course of providing services to patients.
To address effective communication with patients who are limited
English proficiency (LEP) or have disabilities, we proposed a new
standard at Sec. 484.50(f), ``Accessibility.'' We proposed that
information that is provided to patients would have to be provided to
the individual in plain language, and in a manner that is both
accessible and timely.
In accordance with the requirements of the Medicare provider
agreement, HHAs must not discriminate against Medicare beneficiaries,
and if a participating HHA accepts non-Medicare patients at any given
level of acuity, it must also accept Medicare beneficiaries at a
similar level of acuity

[[Page 4508]]

as a condition of participating in the Medicare program. HHAs that
provide services to non-Medicare patients while refusing services to
Medicare patients in similar situations risk having their provider
agreements terminated, in accordance with Sec. 489.53(a)(2).
4. Comprehensive Assessment of Patients (Proposed Sec. 484.55)
We proposed to retain the majority of the substantive requirements
of current Sec. 484.55, with significant reorganization. We proposed
to retain the requirement that each patient be required to receive a
patient-specific comprehensive assessment. We also proposed to retain
the requirement that, for Medicare beneficiaries, the HHA would be
required to verify the patient's eligibility for the Medicare home
health benefit, including the patient's homebound status, at the
specified timeframes. Furthermore, we proposed to retain all
requirements related to the initial assessment visit at standard (a),
as well as the completion of the comprehensive assessment requirements
at standard (b).
We proposed to establish a new standard (c), ``Content of the
comprehensive assessment,'' that would incorporate much of the content
currently set forth in the introductory paragraph of the CoP, the drug
regimen review currently set forth in standard (c), and the
incorporation of the OASIS data items requirement currently set forth
at standard (e). We also proposed new content requirements, such as an
assessment of psychosocial and cognitive status, which we believe would
provide for a more holistic patient assessment. We believe that these
assessment areas are essential in the establishment of a more complete
understanding of the patient's condition (both medically and non-
medically), strengths and limitations, preferences, and risk factors.
Developing a more complete understanding of the patient will enable
HHAs and physicians to develop a plan of care that is more
comprehensive and more likely to achieve desired outcomes. We proposed
to require that the comprehensive assessment must accurately reflect
the patient's status, and would assess or identify (as applicable) the
following:
The patient's current health, psychosocial (new),
functional (new), and cognitive (new) status;
The patient's strengths, goals, and care preferences,
including the patient's progress toward achievement of the goals
identified by the patient and the measurable outcomes identified by the
HHA (new);
The patient's continuing need for home care;
The patient's medical, nursing, rehabilitative, social,
and discharge planning needs;
A review of all medications the patient is currently
using;
The patient's primary caregiver(s), if any, and other
available supports (new); and
The patient's representative (if any) (new).
The assessment would also be required to incorporate items from the
information collection set out in the OASIS data set, using the
language and groupings of the OASIS items, as specified by the
Secretary.
We proposed to retain the majority of the content of the
requirements of current Sec. 484.55(d), with one change. We proposed
to revise Sec. 484.55(d)(2) to allow for a physician-ordered
resumption of care date. Adding the physician ordered resumption of
care date as an alternative to the fixed 48 hour time frame for a post-
hospital reassessment allows physicians to specify a resumption of care
date that is tailored to the particular needs and preferences of each
patient.
5. Care Planning, Coordination of Services, and Quality of Care
(Proposed Sec. 484.60)
We proposed to create a new condition of participation, ``Care
planning, coordination of services, and quality of care'' at Sec.
484.60. This section would specify that the HHA would have to provide
the patient a plan of care that would set out the care and services
necessary to meet the patient-specific needs identified in the
comprehensive assessment, and the outcomes that the HHA anticipates
would occur as a result of developing the individualized plan of care
and subsequently implementing its elements.
In the CoP, we proposed that patients be accepted for treatment on
the basis of a reasonable expectation that the patient's medical,
nursing, rehabilitative, and social needs could be met adequately by
the agency in the patient's place of residence. Each patient would
receive an individualized written plan of care which would specify the
care and services necessary to meet the patient's needs, including the
patient and caregiver education and training that the HHA will provide,
specific to the patient's care needs. The individualized plan of care
would be revised or added to at intervals as necessary to continue to
meet patient care needs. We also proposed that the plan of care include
the patient-specific measurable outcomes which the HHA anticipates
would result from its implementation.
Under proposed Sec. 484.60(a)(1), Plan of care, we proposed that
all home health services furnished to patients would follow an
individualized written plan of care, setting out, among other things,
the frequency and duration of therapeutic interventions. The plan would
be established, periodically reviewed, and signed by a doctor of
medicine, osteopathy, or podiatric medicine acting within the
boundaries of all applicable state laws and regulations. Under
paragraph (a)(2), the individualized plan of care would be required to
include all pertinent diagnoses; the patient's mental, psychosocial,
and cognitive status; the types of services, supplies, and equipment
required; the frequency and duration of visits to be made; prognosis;
rehabilitation potential; functional limitations; activities permitted;
nutritional requirements; all medications and treatments; safety
measures to protect against injury; patient and caregiver education and
training to facilitate timely discharge or referral; patient-specific
measurable outcomes/goals; and any additional interventions/orders the
HHA or physician chose to include.
Under paragraph (a)(3), if HHA services are initiated following a
patient's hospital discharge, we proposed to require that the HHA
include an assessment of the patient's level of risk for hospital
emergency department visits and hospital re-admission. We proposed that
HHAs would be required to include in the patient's individualized plan
of care all appropriate interventions that are necessary to address and
mitigate identified risk factors that contribute to the HHA's
establishment of a particular risk level for a patient.
Proposed Sec. 484.60(b), ``Conformance with physician orders,''
would provide that drugs, services, and treatments be administered only
as ordered by the physician who is responsible for the home health plan
of care. We proposed to retain the current influenza and pneumococcal
vaccination requirement at Sec. 484.60(b)(2). Proposed Sec.
484.60(b)(3) would maintain the requirement that only personnel
authorized by applicable state laws and regulations and the HHA's
internal policies, may accept verbal orders from physicians. We
proposed at Sec. 484.60(b)(4) that a registered nurse (RN) or other
qualified practitioner licensed to practice by the state must document
a verbal order in writing in the patient's clinical record, with a
signature, time, and date. Verbal orders would also have to be recorded
in the patient's plan of care. If a

[[Page 4509]]

physician faxed orders or otherwise transmitted them through other
electronic methods from his or her office, those orders would also be
required to be included in the patient's clinical record and plan of
care. We would also require that verbal orders be authenticated, dated,
and timed by the physician according to the HHA's internal policies and
applicable state laws and regulations.
Under Sec. 484.60(c), ``Review and revision of the plan of care,''
we proposed that the individualized plan of care be reviewed and
revised by the physician who was responsible for the HHA plan of care
and the HHA as frequently as the patient's condition or needs requires,
but no less frequently than once every 60 days, beginning with the
start of care date. We proposed that the HHA promptly alert the
physician who is responsible for the HHA plan of care to any changes in
the patient's condition or needs that would suggest that measurable
outcomes are not being achieved and/or that the HHA should alter the
plan. At Sec. 484.60(c)(2), we proposed to require that the HHA revise
the plan of care, as necessary, to reflect current information from the
patient's updated comprehensive assessment, and to record the patient's
progress towards meeting the patient-specific measurable outcomes and
goals selected by the HHA and patient, as specified in the plan of
care.
Furthermore, we proposed at paragraph (c)(3) that it would be the
HHA's responsibility to notify the patient, representative (if any),
caregivers, and the physician who is responsible for the HHA plan of
care, when the individualized plan of care is updated due to a
significant change in the patient's health status. We also proposed
that, when the HHA makes updates related to plans for the patient's
discharge, the HHA would communicate these changes with the patient and
representative, caregivers, the physician who is responsible for the
HHA plan of care, and the patient's primary care practitioner or other
health care professional who will be responsible for providing care and
services (if any) to the patient after discharge from the HHA.
In Sec. 484.60(d), ``Coordination of care,'' we proposed in
paragraph (d)(1) to require that the HHA must integrate services,
whether services are provided directly or under arrangement, to assure
the identification of patient needs and factors that could affect
patient safety and treatment effectiveness, the coordination of care
provided by all disciplines, and communication with the physician. The
proposed standard at Sec. 484.60(d)(2) would also require the HHA to
coordinate care delivery to meet each patient's needs, and to involve
the patient, representative (if any), and caregiver(s), as appropriate,
in the coordination of care activities. Finally, under proposed Sec.
484.60(d)(3), we proposed that the HHA ensure that each patient and
caregiver, where applicable, receive ongoing training and education
from the HHA regarding the care and services identified in the plan of
care that the patient and caregiver are expected to implement. The HHA
would be required to ensure that each patient and caregiver receives
any training necessary for a timely discharge from the HHA. Each
skilled professional would be expected to be responsible for educating
the patient and/or caregiver about the care and services as appropriate
to the discipline.
At Sec. 484.60(e), ``Discharge or transfer summary,'' we proposed
that HHAs be required to compile a discharge or transfer summary for
each discharged or transferred patient. The summary would be required
to include the following:
The initial reason for referral to the HHA;
A brief description of the patient's HHA care;
A description of the patient's clinical, mental,
psychosocial, cognitive, and functional status at the start of care;
A list of all services provided by the HHA to the patient;
The start and end dates of HHA care;
A description of the patient's clinical, mental,
psychosocial, cognitive; and functional status at the end of care;
The patient's most recent drug profile;
Any recommendations for follow-up care;
The patient's current individualized plan of care; and
Any additional documentation that would assist in the
continuity of post-discharge or transfer care, or that was requested by
the receiving practitioner or facility.
6. Quality Assessment and Performance Improvement (QAPI) (Proposed
Sec. 484.65)
As part of our effort to reduce medical errors, and improve the
quality of health care in all settings, we propose to replace two
current HHA CoPs, Sec. 484.16, ``Group of professional personnel,''
and Sec. 484.52, ``Evaluation of the agency's program,'' with a
single, new CoP, at Sec. 484.65, ``Quality Assessment and Performance
Improvement'' (QAPI). We have organized this new CoP into the following
five standards: (1) Program scope; (2) Program data; (3) Program
activities; (4) Performance improvement projects; and (5) Executive
responsibilities.
In Sec. 484.65(a), ``Program scope,'' we proposed that this data-
driven QAPI program would be capable of showing measurable improvement
in indicators for which there was evidence that the improvement led to
improved health outcomes (for example, reduced hospitalizations and
readmissions), safety, and quality of care for patients. The HHA would
also have to measure, analyze, and track quality indicators, including
adverse patient events, as well as other indicators of performance so
that the agency could adequately assess its processes, services, and
operations.
We proposed, at Sec. 484.65(b), ``Program data,'' that an HHA's
QAPI program utilize quality indicator data, including measures derived
from the OASIS (CMS provided reports), where applicable, and other
relevant data, to assess the quality of care provided to patients, and
identify and prioritize opportunities for improvement. Quality
assessment efforts, including data collection, should focus on high
priority safety and health conditions, and other goals identified by an
HHA. The tools, collected data, and associated quality measures would
be used by the HHA to monitor the effectiveness and safety of its
services, as well as the quality of its care. In addition, the HHA
would use the quality measures that are calculated based on the data
collected to identify opportunities for improvement. We also proposed
that the HHA's governing body would be responsible for approving the
frequency of, and level of detail to be used in data collection.
At Sec. 484.65(c), ``Program Activities,'' we would require an
HHA's QAPI program activities to focus on high risk, high volume, or
problem-prone areas of service, and to consider the incidence,
prevalence, and severity of problems in those areas. We also proposed
that the HHA immediately correct any identified problems that directly
or potentially threaten the health and safety of patients.
Additionally, the HHA's QAPI activities would have to track incidents
and adverse patient events, as well as analyze those events, so that
preventive actions and mechanisms could be implemented by the HHA. We
also proposed that after steps have been taken to improve an area of
concern, the HHA would continue to monitor the area in order to assure
that improvements were sustained over time.

[[Page 4510]]

Proposed Sec. 484.65(d), ``Performance improvement projects,''
would require that the HHA's performance improvement projects,
conducted at least annually, reflect the scope, complexity, and past
performance of the HHA's services and operations. An agency would need
to focus on those areas of past performance which have proven to be
problematic for the HHA over time or areas where there was clear
evidence of poor patient outcomes, as well as areas of high-risk and
high-volume. Within this standard, we also proposed that the HHA
document the QAPI projects undertaken, the reasons for conducting these
projects, and the measurable progress achieved.
Finally, under proposed Sec. 484.65(e), ``Executive
responsibilities,'' we would require that the HHA's governing body
assume responsibility for the agency's QAPI program. This subsection
would require that the governing body assume the overall responsibility
for ensuring that the QAPI program reflected the complexity of the HHA
and its services, involved all services (including those provided under
contract or arrangement), focused on indicators related to improved
outcomes, and took actions that addressed the HHA's performance across
the spectrum of care, including the prevention and reduction of medical
errors. The governing body would be required to define, implement, and
maintain a program for quality improvement and patient safety that was
ongoing and agency-wide. The governing body would be required not only
to ensure that performance improvement efforts were prioritized, but
that they were also evaluated for effectiveness. We note that it is the
governing body which would be ultimately responsible for establishing
the HHA's expectations for patient safety through an agency-wide QAPI
program. Therefore, we proposed that the governing body establish clear
expectations for patient safety. We also proposed that the governing
body would appropriately address any findings of fraud or waste in
order to assure that resources are appropriately used for patient care
activities and that patients are receiving the right care to meet their
needs.
7. Infection Prevention and Control (Proposed Sec. 484.70)
We proposed to establish a new CoP at Sec. 484.70, ``Infection
prevention and control,'' organized under the following three
standards: (1) Prevention, (2) Control, and (3) Education. We proposed
in Sec. 484.70(a) that HHAs follow infection prevention and control
best practices, which include the use of standard precautions, to curb
the spread of disease. Under proposed standard Sec. 484.70(b),
``Control,'' we would expect the HHA to maintain a coordinated agency-
wide program for the surveillance, identification, prevention, control,
and investigation of infectious and communicable diseases.
Additionally, under this proposal, the program would be expected to be
an integral part of the agency's QAPI program. We proposed an education
standard within this CoP at Sec. 484.70(c). HHAs would be expected to
provide education on ``current best practices'' to staff, patients, and
caregivers.
8. Skilled Professional Services (Proposed Sec. 484.75)
This proposed new condition would set forth the requirements for
skilled professional services. Instead of specifically identifying
tasks, we proposed to broadly describe the expectations of the skilled
professionals who participate in the interdisciplinary team approach to
home health care delivery. Skilled professionals, within this context,
would provide services to HHA patients directly as employees of the HHA
or under a contractual agreement. We proposed that skilled
professionals actively participate in the coordination of all aspects
of care where appropriate. We have organized this proposed condition
into three areas: (1) Skilled professional services; (2)
Responsibilities of skilled professionals; and (3) Supervision of
skilled professional assistants. Skilled professional services, as
proposed in Sec. 484.75(a), include physician services, skilled
nursing services, physical therapy, speech-language pathology services,
occupational therapy, and medical social work services. Provision of
services by skilled professionals, as proposed in Sec. 484.75(b),
would specify that skilled professional services may only be provided
by health care professionals who meet the appropriate criteria spelled
out in proposed Sec. 484.115, ``Personnel qualifications,'' and who
practice according to the HHA's policies and procedures.
We proposed in Sec. 484.75(b), ``Responsibilities of skilled
professionals,'' that skilled professionals who provide services to HHA
patients directly, or under arrangement, participate in coordinating
all aspects of care, including:
Assuming responsibility for the ongoing interdisciplinary
assessment and development of the individualized plan of care in
partnership with the patient, representative (if any), and
caregiver(s);
Providing services that are ordered by the physician as
indicated in the plan of care;
Providing patient, caregiver, and family counseling;
Providing patient and caregiver education;
Preparing clinical notes;
Communicating with the physician who is responsible for
the home health plan of care and other health care practitioners (as
appropriate) related to the current home health plan of care; and
Participating in the HHA's quality assessment and
performance improvement program and HHA-sponsored in-service training.
In addition to the requirements for licensed professional services
described above, we proposed to include a requirement governing the
supervision of skilled professional assistants at Sec. 484.75(c). This
would require an RN identified by the HHA to supervise the care
provided by nurses such as licensed vocational nurses and licensed
practical nurses. We also proposed that all rehabilitative therapy
assistant services would be provided under the supervision of a
physical therapist (PT) or occupational therapist (OT) who meets the
appropriate requirements of Sec. 484.115. Furthermore, we believe that
it is essential for all medical social services to be provided under
the overall supervision of a Master of Social Work (MSW) prepared
social worker who meets the requirements of Sec. 484.115.
9. Home Health Aide Services (Proposed Sec. 484.80)
We proposed to organize the home health aide requirements as nine
standards under Sec. 484.80: (1) Home health aide qualifications; (2)
content and duration of home health aide classroom and supervised
practical training; (3) competency evaluation; (4) in-service training;
(5) qualifications for instructors conducting classroom and supervised
practical training; (6) eligible training and competency evaluation
organizations; (7) home health aide assignments and duties; (8)
supervision of home health aides; and (9) individuals furnishing
Medicaid personal care aide-only services under a Medicaid personal
care benefit.
At proposed Sec. 484.80(a)(1), we would specify the necessary
requirements for an individual to be considered a qualified home health
aide. A qualified home health aide would be an individual who has
successfully completed one of the following: (1) A training and
competency evaluation program that meets the requirements

[[Page 4511]]

described in Sec. 484.80(b) and Sec. 484.80(c); or (2) a competency
evaluation program that meets the requirements described in Sec.
484.80(c); or (3) a nurse aide training and competency evaluation
program that is approved by the state as meeting the requirements of
Sec. 483.151 through Sec. 483.154 and is currently listed in good
standing on the state nurse aide registry; or (4) a state licensure
program that meets the requirements described in Sec. 484.80(b) and
Sec. 484.80(c).
Under proposed Sec. 484.80(a)(2), we would specify when a home
health aide is deemed to have completed a program (as specified in
proposed Sec. 484.80(a)(1)). This determination would be based on
whether, since the most recent completion of a program, there was a
period of 24 months or greater since completion of the last home health
aide training during which none of the services furnished by the aide
were for compensation. We would also stipulate that, if there had been
a 24-month or greater lapse in furnishing services, the aide would need
to complete another program before the home health aide can provide
services, as specified in Sec. 484.80(a)(1).
We proposed, at Sec. 484.80(b), to set forth the requirements for
training content and its duration, training methods (classroom and
practical), and training documentation. At Sec. 484.80(b)(4), we
proposed to require the HHA to maintain documentation that the
requirements for content and duration of home health aide classroom and
supervised practical training have been met.
We proposed to address various requirements for the competency
evaluation of home health aides in Sec. 484.80(c). We proposed to
retain the requirement currently found at Sec. 484.36(b)(1), which
states that an individual may furnish home health aide services on
behalf of an HHA only after the successful completion of a competency
evaluation program as described in that section. In accordance with
proposed Sec. 484.80(c)(2), the competency evaluation described in
this paragraph may be offered by any organization, except an
organization that falls under one of the exceptions specified in the
regulation as described in proposed paragraph (f) of this section.
Section 484.80(c)(3) would maintain the current requirement that an RN
must perform the competency evaluation. In addition to the RN, we
proposed that the competency evaluation be done in consultation with
other skilled professionals, as appropriate. We proposed that, if a
home health aide is going to perform a task for which he or she was
rated ``unsatisfactory,'' it must be performed under the supervision of
a licensed nurse (either a licensed practical nurse or an RN) until he
or she achieves an evaluation of ``satisfactory.''
At Sec. 484.80(d), we would retain 12 as the minimum number of
hours of in-service training required for a 12-month period. The
training could occur while an aide was furnishing care to a patient.
Proposed Sec. 484.80(b) would set forth the elements that must
comprise home health aide classroom and supervised practical training,
thus suggesting that those elements of training should form a basis for
ongoing in-service training. We proposed that aide in-service training
could be offered by any organization, and that the training would be
required to be supervised by an RN.
We proposed to relocate the requirement that the RN that conducts
training possess a minimum of 2 years of nursing experience, of which
at least 1 year is in home health care, to standard (e),
``Qualifications for instructors conducting classroom and supervised
practical training.'' We continue to believe that RNs with nursing
experience in the home health field should be the principal instructors
in the basic training of home health aides. While other individuals
could provide instruction to home health aides, classroom and practical
training would be required to be under the general supervision of an RN
who possessed a minimum of 2 years nursing experience, at least 1 year
of which would have to be in home health care.
We proposed to retain the current requirements regarding
organizations that offer aide training at Sec. 484.80(f), ``Eligible
training and competency evaluation organizations.'' We proposed to
retain the current requirement that home health aide training may be
provided by any organization, except an organization that falls under
one of the exceptions specified in the regulation. These exceptions
include, but are not limited to, agencies that have been found out of
compliance with the home health aide requirements any time in the last
2 years, agencies that permitted an unqualified individual to function
as a home health aide, and agencies that have been found to have
compliance deficiencies that endangered patient health and safety. The
full list of exceptions are included in the regulatory text.
We proposed, at Sec. 484.80(g), ``Home health aide assignments and
duties,'' to set forth aide responsibilities and duties. Proposed Sec.
484.80(g)(1) would provide that the home health aide would be assigned
to a specific patient by the RN or other appropriate skilled
professional (that is, physical therapist, speech-language pathologist,
or occupational therapist). Proposed Sec. 484.80(g)(2) would require
that the home health aide provide services that are ordered by the
physician in the plan of care, that the home health aide is permitted
to perform under state law, and that are consistent with the home
health aide training. In Sec. 484.80(g)(3), we proposed to retain the
inclusive listing of duties for home health aides currently under Sec.
484.36(c)(2). At Sec. 484.80(g)(4) we proposed a requirement that home
health aides be members of the interdisciplinary team, must report
changes in the patient's condition to an RN or other appropriate
skilled professional, and must complete appropriate records in
compliance with the HHA's policies and procedures.
On-going home health aide supervision, as described in proposed
Sec. 484.80(h), ``Supervision of home health aides,'' is a necessary
component of quality care for HHAs, and ensures that services provided
by home health aides are in accordance with the agency's policies and
procedures and in accordance with state and federal law. In this
proposed standard, we would differentiate the aide supervision
requirements based on the skill level of the care required by the
patient. In proposed Sec. 484.80(h)(1), we proposed that if a patient
is receiving skilled care, the home health aide supervisor (RN or
therapist) must make an onsite visit to the patient's home no less
frequently than every 14 days. The home health aide would not have to
be present during this visit. If a potential deficiency in home health
aide service was noted by the home health aide supervisor, then the
supervisor would have to make an on-site visit to the location where
the patient was receiving care in order to observe and assess the home
health aide while he or she is performing care. In addition to the
regularly scheduled 14-day supervision visits and the as-needed
observation visits, HHAs would be required to make an annual on-site
visit to a patient's home to observe and assess each home health aide
while he or she is performing patient care activities. The HHA would be
required to observe each home health aide with at least one patient.
In proposed Sec. 484.80(h)(2), we would require that if home
health aide services are provided to a patient who is not receiving
skilled care, the RN must make an on-site visit to the location where
the patient is receiving care no less frequently than every 60 days in
order to observe and assess each home

[[Page 4512]]

health aide while he or she is performing care.
At proposed Sec. 484.80(h)(3), we would require that if a
deficiency in home health aide services was verified by the home health
aide supervisor during an on-site visit, then the agency would have to
conduct, and the home health aide would have to complete, a competency
evaluation in accordance with paragraph (c) of this section.
We also proposed to add a new paragraph at Sec. 484.80(h)(4) to
ensure that home health aide supervision visits focus on the aide's
ability to demonstrate initial and continued satisfactory performance
in meeting essential criteria. Supervision visits would be required to
assess the home health aide's success in following the patient's plan
of care; completing tasks assigned to the home health aide;
communicating with the patient, representative (if any), caregivers,
and family; demonstrating competency with assigned tasks; complying
with infection prevention and control policies and procedures;
reporting changes in the patient's condition; and honoring patient
rights.
Proposed Sec. 484.80(h)(5) would retain, with minor revisions, the
current requirements found under Sec. 484.36(d)(4) as they relate to
the HHA's responsibilities for home health aides who are furnishing
services under arrangement (that is, the aides are not employees of the
HHA). The HHA would be required to ensure the quality of home health
aide services, supervise aides as proposed in this section, and ensure
that aides have met the training and competency evaluation requirements
of this proposed part.
At proposed Sec. 484.80(i), ``Individuals furnishing Medicaid
personal care aide-only services under a Medicaid personal care
benefit,'' we proposed to retain the requirements at current Sec.
484.36(e), with some minor clarifying revisions. Under this provision,
a Medicare-certified HHA that provides personal care aide services to
Medicaid patients under a State Medicaid personal care benefit would be
required to determine and ensure the competency of individuals for
those Medicaid-approved services performed. In addition, the reference
to Sec. 440.170 in the current regulation at Sec. 484.36(e)(2) is
incorrect; it should read Sec. 440.167. Therefore, we proposed to make
the necessary correction.

D. Proposed Subpart C, Organizational Environment

1. Compliance With Federal, State, and Local Laws and Regulations
Related to Health and Safety of Patients (Proposed Sec. 484.100)
We proposed that HHAs must be in compliance with all Federal, State
and local laws related to the health and safety of patients, and that
HHA services must be furnished in accordance with accepted professional
standards and principles. We also proposed specific disclosure of
ownership requirements. At Sec. 484.100(a), we proposed to continue to
require HHAs to comply with the requirements of part 420, subpart C by
disclosing the names and addresses of all persons with an ownership or
controlling interest, the name and address of each officer, director,
agent, or managing employee, and the name and address of the entity
responsible for the management of the HHA along with the names and
addresses of the CEO and chairperson of the board of that entity.
Under the provisions of proposed Sec. 484.100(b), an HHA, its
branches, and its staff would be licensed, certified, or registered, as
applicable, by the state licensing authority if the state had
established licensure requirements. If a state requires an HHA to have
a license, then we would require that the provider be in compliance
with that state's law or regulation.
Finally, we proposed at Sec. 484.100(c), ``Laboratory services,''
to require that HHAs engaged in certain types of lab testing, with an
appliance that has been approved for that purpose by the Food and Drug
Administration, conduct testing in compliance with the requirements of
42 CFR 493 (Laboratory Requirements). This section would also prohibit
HHAs from substituting their own self-administered testing equipment in
lieu of a patient's self-administered testing equipment when assisting
a patient in administering the test. In addition, this section would
provide that if the HHA chose to refer specimens for laboratory
testing, the referral laboratory would have to be certified in
accordance with the applicable requirements of part 493. The laboratory
services standard is a federal requirement in accordance with the
Clinical Laboratory Improvement Amendments of 1988 (CLIA).
2. Organization and Administration of Services (Proposed Sec. 484.105)
We proposed at Sec. 484.105(a), ``Governing body,'' to require the
governing body to be able to assess the HHA's financial needs and to
assume responsibility for effectively managing its financial resources,
as well as assume full legal authority and responsibility for the
agency's overall management and operation, the provision of all home
health services, the review of the budget and operational plans, and
the agency's quality assessment and performance improvement program.
Proposed Sec. 484.105(b), ``Administrator,'' described the role of
the administrator and provisions for when the administrator is not
available. We proposed that the administrator be appointed by the
governing body, be responsible for all day to day operations of the
HHA, and be responsible for ensuring that a skilled professional as
described in Sec. 484.75 is available during all operating hours. We
proposed that, any time when the administrator is not available, a pre-
designated person, who is authorized in writing by the administrator
and governing body, would assume the same responsibilities and
obligations as the administrator, including the responsibility to be
available during all operating hours.
In addition to the overall management of the HHA by the governing
body and the administrator, we proposed a new clinical manager role at
Sec. 484.105(c). The clinical manager would be a qualified licensed
physician or registered nurse, identified by the HHA, who is
responsible for the oversight of all personnel and all patient care
services provided by the HHA, whether directly or under arrangement, to
meet patient care needs. The supervision of HHA personnel would include
assigning personnel, developing personnel qualifications, and
developing personnel policies.
In Sec. 484.105(d), we proposed a new standard, ``Parent-branch
relationship,'' to focus on the ability of the parent HHA to
demonstrate that it can monitor all services provided in its entire
service area, furnished by any branch offices, to ensure compliance
with the CoPs. We would require that HHAs report their branch locations
to the state survey agency at the time of an HHA's initial
certification request, at each survey, and at the time any proposed
additions or deletions were made.
We proposed at Sec. 484.105(e), ``Services under arrangement,'' to
govern all services provided under arrangement with another agency or
organization. The agency providing services under arrangement may not
have been denied Medicare enrollment; been terminated from Medicare,
another federal health care program, or Medicaid; had its Medicare or
Medicaid billing privileges revoked; or been

[[Page 4513]]

debarred from participating in any government program. We proposed to
require that the primary HHA have a written agreement with another
agency, with an organization, or with an individual, that it has
contracted with to provide services to its patients, which stipulates
that the primary HHA would maintain overall responsibility for all HHA
care provided to a patient in accordance with the patient's plan of
care, whether the care is provided directly or under arrangement. If
the primary HHA chooses to furnish some services under arrangement,
then it retains management, service oversight, and financial
responsibility for all services that are provided to the patient by its
contracted entities. All services provided by contracted entities would
be authorized by the primary HHA, and furnished in a safe and effective
manner by qualified personnel. In addition to this revision, we
proposed to correct a typographical error in the cross-reference
citation for the United States Code.
As stated in proposed Sec. 484.105(f)(1), skilled nursing and one
of the therapeutic services must be made available on a visiting basis
in the patient's home. At least one service would be required to be
provided directly by the HHA.
We proposed a requirement for compliance with accepted professional
standards and principles at Sec. 484.105(f)(2). We would require that
HHAs furnish all services in accordance with accepted professional
standards of practice. We also proposed to require that all HHA
services be provided in accordance with current clinical practice
guidelines.
We proposed to relocate the requirements for outpatient physical
therapy or speech pathology services to Sec. 484.105(g), without
change.
Finally, we proposed to retain the ``Institutional planning''
standard as required for HHAs under section 1861(z) of the Act at Sec.
484.105(h). We did not propose any revisions to this content.
3. Clinical Records (Proposed Sec. 484.110)
We proposed to retain, with some additional clarification, many of
the long-standing clinical record requirements. The primary requirement
under the proposed clinical records CoP would be that a clinical record
containing pertinent past and current relevant information would be
maintained for every patient who was accepted by the HHA to receive
home health services. We proposed to add the requirement that the
information contained in the clinical record would need to be accurate,
adhere to current clinical record documentation standards of practice,
and be available to the physician who is responsible for the home
health plan of care and appropriate HHA staff. The clinical record
would be required to exhibit consistency between the diagnosed
condition, the plan of care, and the actual care furnished to the
patient.
Proposed Sec. 484.110(a), ``Contents of clinical record,'' would
retain the requirement that the record include clinical notes, plans of
care, physician orders, and a discharge summary. We proposed to require
that the clinical record include: (1) The patient's current
comprehensive assessment, including all of the assessments from the
most recent home health admission, clinical visit notes, and
individualized plans of care; (2) all interventions, including
medication administration, treatments, services, and responses to those
interventions, which would be dated and timed in accordance with the
requirements of proposed Sec. 484.110(b); (3) goals in the patient's
plan of care and the progress toward achieving the goals; (4) contact
information for the patient and representative (if any); (5) contact
information for the primary care practitioner or other health care
professional who will be responsible for providing care and services to
the patient after discharge from the HHA; and (6) a discharge or
transfer summary note that would be sent to the patient's primary care
practitioner or other health care professional who will be responsible
for providing care and services to the patient after discharge from the
HHA within 7 calendar days, or, if the patient is discharged to a
facility for further care, to the receiving facility within 2 calendar
days of the patient's discharge or transfer.
We proposed to add a new standard at Sec. 484.110(b) to require
authentication of clinical records. We proposed that all entries be
legible, clear, complete, and appropriately authenticated, dated, and
timed.
At Sec. 484.110(c), we proposed to require that clinical records
be retained for 5 years after the discharge of the patient, unless
state law stipulates a longer period of time. We would require, in
Sec. 484.110(c)(2), that HHA policies provide for retention of records
even if the HHA discontinues operations. We also proposed that the HHA
would be required to notify the state agency as to where the agency's
clinical records would be maintained.
We also proposed at Sec. 484.110(d) to require that clinical
records, their contents, and the information contained therein, be
safeguarded against loss or unauthorized use.
We proposed to add a new standard at Sec. 484.110(e), ``Retrieval
of clinical records.'' We proposed that a patient's clinical records
(whether hard copy or electronic) be made readily available to a
patient or appropriately authorized individuals or entities upon
request. The provision of clinical records must be in compliance with
the rules regarding protected health information set out at 45 CFR,
parts 160 and 164.
Finally, in the preamble material explaining Sec. 484.110, we
provided information regarding the HHS Policy Priority to Accelerate
Interoperable Health Information Exchange, including Use of Certified
Electronic Health Record Technology.
4. Personnel Qualifications (Proposed Sec. 484.115)
We proposed a new ``Personnel qualifications'' CoP, with conforming
amendments to the regulations for the other provider types that cross-
reference the HHA personnel requirements. We proposed to retain the
current personnel qualifications for the following professions:
Audiologist, home health aide, licensed practical nurse, occupational
therapist, occupational therapy assistant, physical therapist, physical
therapist assistant, physician, registered nurse, social work
assistant, and social worker. We also proposed to replace the term
``practical (vocational) nurse,'' currently found in Sec. 484.4, with
the more widely used and accepted term, ``licensed practical nurse.''
We also proposed to revise the current personnel qualifications for
HHA administrators. Specifically, we proposed that an HHA administrator
would be required to be a licensed physician, or hold an undergraduate
degree, or be a registered nurse. We also proposed that an
administrator would have at least 1 year of supervisory or
administrative experience in home health care or a related health care
program.
Finally, we proposed at Sec. 484.115(m) to revise the personnel
qualifications for speech-language pathologists (SLP) in order to more
closely align the regulatory requirements with those set forth in
section 1861(ll)(4)(A) of the Act. We proposed that a qualified SLP is
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 these services. Should a state
choose to not offer licensure at some point in the future, we proposed
a second, more specific, option for qualification. In that

[[Page 4514]]

circumstance, we would require that a SLP has successfully completed
350 clock hours of supervised clinical practicum (or is in the process
of accumulating supervised clinical experience); 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 successfully completed a
national examination in speech-language pathology approved by the
Secretary.

III. Home Health Crosswalk (Cross Reference of Former to New
Requirements)

The table below shows the relationship between the former sections
to the new regulations.

------------------------------------------------------------------------
Current CoPs Revised CoPs
------------------------------------------------------------------------
Sec. 484.1, Basis and scope.......... Revised at Sec. 484.1
Sec. 484.2, Definitions.............. Revised at Sec. 484.2
Sec. 484.4, Personnel qualifications. Revised at Sec. 484.115
Home health aide qualifications........ Revised at Sec. 484.80
Sec. 484.10, Patient rights.......... Sec. 484.50, Patient rights
Sec. 484.10(a)....................... Revised at Sec. 484.50(a)
Sec. 484.10(b)....................... Revised at Sec. Sec.
484.50(b), (c), and (e)
Sec. 484.10(c)....................... Revised at Sec. 484.50 (c)
Sec. 484.10(d)....................... Revised at Sec. 484.50(c)
Sec. 484.10(e)....................... Revised at Sec. 484.50(c)
Sec. 484.10(f)....................... Revised at Sec. 484.50(c)
New standard at Sec.
484.50(d), Transfer and
discharge.
New standard at Sec.
484.50(e), Investigation of
complaints.
Sec. 484.11, Release of patient Sec. 484.40, Release of
identifiable OASIS information. patient identifiable OASIS
information.
Sec. 484.12, Compliance with Federal, Sec. 484.100, Compliance with
State, and local laws, disclosure and Federal, State, and local laws
ownership information, and accepted and regulations related to the
professional standards and principles. health and safety of patients.
Sec. 484.12(a)....................... Revised at Sec. 484.100 and
Sec. 484.100(b)
Sec. 484.12(b)....................... Redesignated at Sec.
484.100(a).
Sec. 484.12(c)....................... Revised at Sec. 484.60, Sec.
484.70, and Sec. 484.105(f)
Sec. 484.14, Organization, services, Sec. 484.105, Organization
and administration. and administration of
services.
Sec. 484.14(a)....................... Revised at Sec. 484.105(f).
Sec. 484.14(b)....................... Revised at Sec. 484.105(a).
Sec. 484.14(c)....................... Revised at Sec. 484.105(b).
Sec. 484.14(d)....................... Revised at Sec. 484.105(b),
and Sec. 484.105(c)
Sec. 484.14(e)....................... Revised at Sec. 484.75(b) and
Sec. 484.115.
Sec. 484.14(f)....................... Revised at Sec. 484.105(e).
Sec. 484.14(g)....................... Revised at Sec. 484.60(d) and
Sec. 484.105(c).
Sec. 484.14(h)....................... Revised at Sec. 484.105(e).
Sec. 484.14(i)....................... Revised at Sec. 484.105(h).
Sec. 484.14(j)....................... Revised at Sec. 484.100(c).
Sec. 484.16, Group of professional Deleted, see Sec. 484.65,
personnel. Quality assessment and
performance improvement
(QAPI).
Sec. 484.18, Acceptance of patients, Sec. 484.60, Care planning,
plan of care, and medical supervision. coordination of services, and
quality of care.
Sec. 484.18(a)....................... Revised at Sec. 484.60(a).
Sec. 484.18(b)....................... Revised at Sec. 484.60(c).
Sec. 484.18(c)....................... Revised at Sec. 484.60(b).
New standard at Sec.
484.60(e), Written information
to the patient.
Sec. 484.20, Reporting OASIS Sec. 484.45, Reporting OASIS
information. information.
Sec. 484.30, Skilled nursing services Sec. 484.75, Skilled
professional services.
Sec. 484.32, Therapy services........ Sec. 484.75, Skilled
professional services.
Sec. 484.34, Medical social services. Sec. 484.75, Skilled
professional services.
Sec. 484.36, Home health aide Sec. 484.80, Home health aide
services. services.
Sec. 484.36(a)(1).................... Revised at Sec. 484.80(b).
Sec. 484.36(a)(2)(i)................. Revised at Sec. 484.80(f).
Sec. 484.36(a)(2)(ii)................ Revised at Sec. 484.80(e).
Sec. 484.36(a)(3).................... Revised at Sec. 484.80(b).
Sec. 484.36(b)(1).................... Revised at Sec. 484.80(c).
Sec. 484.36(b)(2)(i)................. Revised at Sec. 484.80(c).
Sec. 484.36(b)(2)(ii)................ Revised at Sec. 484.80(h).
Sec. 484.36(b)(2)(iii)............... Revised at Sec. 484.80(d).
Sec. 484.36(b)(3)(i)................. Revised at Sec. 484.80(c) and
(d).
Sec. 484.36(b)(3)(ii)................ Revised at Sec. 484.80(c) and
(d).
Sec. 484.36(b)(3)(iii)............... Revised at Sec. 484.80(c).
Sec. 484.36(b)(4).................... Revised at Sec. 484.80(c).
Sec. 484.36(b)(5).................... Redesignated at Sec.
484.80(c).
Sec. 484.36(b)(6).................... Deleted.
Sec. 484.36(c)....................... Revised at Sec. 484.80(g).
Sec. 484.36(d)....................... Revised at Sec. 484.80(h).
Sec. 484.36(e)....................... Revised at Sec. 484.80(i).
Sec. 484.38, Qualifying to furnish Revised at Sec. 484.105(g).
outpatient physical therapy or speech
pathology services.
Sec. 484.48, Clinical records........ Sec. 484.110, Clinical
records.
Sec. 484.48(a)....................... Revised at Sec. 484.110(c).

[[Page 4515]]

Sec. 484.48(b)....................... Revised at Sec. 484.110(d).
New standard at Sec.
484.110(a), Contents of
clinical record.
New standard at Sec.
484.110(b), Authentication.
New standard at Sec.
484.110(e), Retrieval of
clinical records.
Sec. 484.52, Evaluation of the Deleted, see Sec. 484.65,
agency's program. Quality assessment and
performance improvement and
Sec. 484.70, Infection
prevention and control.
Sec. 484.55, Comprehensive assessment Sec. 484.55, Comprehensive
of patients. assessment of patients.
------------------------------------------------------------------------

IV. Analysis of and Responses to Public Comments

We received 199 letters of public comment from HHA industry
associations, patient advocacy organizations, HHAs, and individuals. A
summary of the major issues and our responses follow.

Effective Date

Comment: The vast majority of commenters made suggestions related
to the effective date of the final rule. Commenters strongly expressed
a need for a significant period of time to prepare for implementation
of the new rules, noting that HHAs would need to adjust resource
allocation, staffing, and potentially even infrastructure. Recommended
implementation time frames ranged from 6 months to 5 years. The most
frequent suggestion was to implement the final rule 1 year following
its publication.
Response: We agree that it is appropriate to allow additional time
to implement the final rule in order to allow HHAs adequate time to
prepare for these changes. We believe that requiring HHAs to comply
with the requirements of this rule on July 13, 2017 is sufficient to
allow for appropriate HHA preparations to implement these changes.
Therefore, we are finalizing an effective date of July 13, 2017.

Definitions

Comment: We received a few comments in support of the branch and
parent office definition. One commenter strongly supported the change
and emphasized with the automation age and web-based storage and
access, the parent office can easily identify and investigate
exceptions to standards of care for all patients and all employees,
focusing administrative time on investigation, action and improvement.
One commenter suggested CMS use the term of ``Service Location'' in
lieu of ``Branch Office.'' Several commenters asked that CMS clarify
some concerns regarding the branch office definition. The commenters
asked that CMS provide guidance on what constitutes an adequate level
of supervision on a ``daily basis.'' They specifically asked if there
is a certain amount or type of communication between the branch and
parent offices. In addition, one commenter asked whether a survey
citation for a violation in a branch office would apply to the entire
HHA.
Response: We appreciate the public comments regarding this issue.
We will continue to use the term ``branch location'' because it has
been in use for more than a decade, and both HHAs and surveyors are
accustomed to the term. To change the terminology without a pressing
reason to do so would risk unnecessary and unwanted confusion among
HHAs and surveyors. The concept of an adequate level of supervision on
a daily basis is longstanding, and refers to the parent HHA's ability
to demonstrate administrative control over each branch. We did not
propose, nor are we finalizing, any specific requirements for
communication because our primary concern relates to the evidence of
control rather than the process for achieving it. As stated in the
proposed rule, a violation that occurred in care and services being
provided by a branch location would be considered a violation by the
HHA as a whole. Therefore, it is essential for the parent to exercise
adequate control, supervision, and guidance for all branches under its
leadership.
Comment: We received several comments supporting the inclusion of
the proposed definition of quality indicator. One commenter stated it
is a much needed addition. Another commenter stated the addition of
quality indicator as a definition would allow an HHA to take into
account its patient population and unique characteristics while meeting
the needs of the patients.
Response: We appreciate support from the public regarding this
definition, and are finalizing it without change.
Comment: Several commenters submitted comments regarding the
proposed definition of the term ``representative.'' Commenters
supported our goal of creating a patient-centered definition that
acknowledges the importance of patient choice, patient involvement in
his or her care, and the role of family, friends, and caregivers. A
commenter stated that this definition should facilitate more timely
communication and cooperation between the HHA, patient, and
representatives and family members. However, a few commenters expressed
concern with the potential for confusion between legally designated
representatives, such as a legal guardian, and patient-designated
representatives. One commenter stated that HHAs may face questions of
whom to listen to in situations where a patient has designated a
representative who may not have legal status to make health care
decisions. Another commenter stated that state laws regarding the
rights and responsibilities of those with health care power of attorney
can sometimes prevent an HHA from responding to communications and
requests from a caregiver or loved one. The commenter suggested that
the definition of ``representative'' should clearly acknowledge that
legal limitations may exist that limit the HHA's ability to be
responsive to communications and requests from patient-identified
representatives at any given point in time. Recognition of this fact in
the definition will assist agencies in managing those complex and
conflicted situations that arise in the delivery of home health
services. Similarly, another commenter suggested that the term
``representative'' be used only where the requirements include
decision-making authority, while a different term, such as
``caregiver'' be used when the requirement is in relation to those
individuals that provide support to the patient.
Response: We appreciate the broad-based support for this patient-
centered definition of the term ``representative.'' We acknowledge that
patients may have several different representatives, each serving a
different support and/or decision making role in the patient's life.
Although conflicts between representatives who have legal authority and
those who do not do have legal authority exist, we believe that these
situations are relatively uncommon. The resolution of such conflicts
would be dependent upon the exact scope of the legal representation.
For example, an

[[Page 4516]]

individual may serve as a patient's representative solely for financial
decision making, meaning that the individual would not have health care
decision making authority, and would therefore be in no more
significant of a position than any other individual chosen by the
patient to serve as a patient-selected representative. If an individual
was the legally designated or appointed health care decision maker, the
HHA would be expected to act in accordance with the decisions made by
that individual while still giving preference to patient choices within
the boundaries of that legal representation relationship. As stated in
the proposed rule (79 FR 61168), if an HHA has reason to believe that
the representative is not acting in accordance with what the patient
would want, is making decisions that could cause harm to the patient,
or otherwise cannot perform the required functions of a representative,
we would expect the HHA to make referrals and/or reports to the
appropriate agencies and authorities to assure the health and safety of
the patient. We do not believe that it would be appropriate to revise
the definition of the term ``representative'' in an attempt to factor
in the wide variety of legal relationships that may or may not exist;
as such an attempt would inevitably fail to account for every
possibility. We do agree that it is necessary to distinguish between
those representatives that are chosen by a patient, but who may not
have legal standing, and those representatives who are acting on legal
authority to make health care decisions for a patient. While a
commenter suggested that the term ``caregiver'' would be appropriate
for those representatives that are chosen by a patient, but who do not
have legally established decision making authority, we believe that the
phrase ``patient-selected representative'' is a more appropriate way to
express this concept. Likewise, when referring to those representatives
who are acting on legal authority to make health care decisions for a
patient, we will use the term ``legal representative.'' We believe that
using the modifiers ``patient-identified'' and ``legal'' when referring
to the types of ``representatives'' that a patient may have will help
clarify the expectations for HHAs.
Comment: A commenter suggested that, if a representative is not
following what the patient requests or is causing harm to the patient
in any way, the HHA staff should report such disagreements or harm to
HHA management so that HHA management can take appropriate steps to
ensure the safety of the patient, including reporting harm to outside
entities.
Response: We agree with this statement. As we stated in the
proposed rule, ``If an HHA has reason to believe that the
representative is not acting in accordance with what the patient would
want, is making decisions that could cause harm to the patient, or
otherwise cannot perform the required functions of a representative, we
would expect the HHA to make referrals and/or reports to the
appropriate agencies and authorities to assure the health and safety of
the patient.''
Comment: We received a few comments that directly asked for CMS to
revise or clarify the requirements for verbal orders. The commenters
stated that other licensed practitioners, such as physician's
assistants and nurse practitioners, should be permitted to give verbal
orders for treatment. Another commenter requested additional
clarification of the word ``spoken.''
Response: Section 1861(m) of the Act requires the HHA plan of care
to be under the direction of a physician. We do not have statutory
authority to allow other licensed practitioners to give verbal orders
for treatment, as such an allowance would mean that the plan of care
would no longer be under a plan established by a physician because
pieces of that plan would be established by non-physicians. We intended
a plain language meaning of the term ``spoken'' as meaning a
communication that is said aloud or communicated by sign language.
Comment: One commenter stated that he or she disagrees with what
appears to be another sub-regulatory process for the definitions of
``in advance,'' ``quality indicator'' and ``supervised practical
training.''
Response: The proposed rule included definitions for these terms
within the regulation. Thus, we did not propose a ``sub-regulatory''
process for these definitions.
Comment: One commenter asked if CMS meant to remove the definition
of ``nonprofit agency'' in the proposed rule.
Response: Removing the definition of the term ``nonprofit agency''
was intentional. This term is not used within the regulatory text;
therefore it is not necessary to define a term that no longer exists.
Comment: One commenter stated they did not support the
``subregulatory process'' and deletion of the terms ``bylaws'' and
``supervision'' in the proposed rule because they feel the two
definitions are important in the delivery of care and organizational
structure.
Response: We proposed to delete a definition of the term ``bylaws''
because the term is not included in the regulatory text. It is not
necessary to define a term that is not used. We proposed to delete the
term ``supervision'' because a single definition of the term cannot
adequately encompass the variety of ways in which the term is used in
this rule. To set forth a single definition of the term would create
more confusion rather than resolve it.
Comment: Several commenters asked CMS to amend Sec. 484.14(a) to
define ``agency employee'' by referencing common law definition of
employee, or issue other guidance clarifying that CMS will interpret
``agency employee'' in accordance with the common law definition of
employee. This guidance is utilized for payroll and accounting purposes
for issuance of W-2 forms for the HHA. One commenter asked that CMS
define the term ``professional employment organization.''
Response: The regulation does not include the term ``agency
employee;'' therefore we are not defining it. Where the term
``employee'' is used, CMS generally considers an employee someone for
whom the facility issues a W-2. The regulation does not include the
term ``professional employment organization''; therefore it is
unnecessary to set forth a definition for this term.
Comment: A commenter asked that CMS include the definition of
``caregiver'' in the final rule. They asked for CMS to clarify what the
term ``caregiver'' is meant to encompass and how the term differs from
``family.'' They suggest CMS use the term ``family caregivers,'' which
refers to any relative, partner, friend or neighbor of the patient who
has a significant relationship with, and who provides a broad range of
assistance to, the patient.
Response: The term ``caregiver'' refers to any individual who
renders uncompensated care to a patient, whereas the term ``family''
refers to legal and/or blood relationships. We do not believe that it
is necessary to define the term because it is not an HHA-specific term
of art, nor is it being used to have a special meaning in this rule.
Furthermore, we believe that adding a definition would run the risk of
inadventently excluding a type of caregiver, which would be detrimental
to patients, caregivers, and HHAs alike. Many times ``caregivers'' are
``family'' members, but this is not a requirement. For example, a
patient's child may live out of state and be considered a ``family''
member, but would not render care to the patient as distance would

[[Page 4517]]

preclude such an arrangement. Therefore, the daughter would be a
``family'' member, but not a ``caregiver.'' We do not believe that
using the term ``family caregivers'' would bring greater clarity to our
meaning, as such a term would inappropriately imply that only family
members can be caregivers. Rather than being inclusive of neighbors,
friends, church members, etc., the term ``family caregivers'' would
imply that these individuals are not included in the broad category of
``caregivers.''
Release of Patient Identifiable Outcome and Assessment Information Set
(OASIS) Information and Reporting OASIS Information
Comment: We received many supportive comments regarding the
proposed OASIS data reporting requirements. Several of the commenters
believe the changes are more consistent with electronic reporting
technology and software that is currently being utilized for data
transmission. One commenter stated they believe the proposed OASIS
changes combine most of the current requirements and the language
reflects current technological terms.
Response: We appreciate the support of the commenters, and are
finalizing these sections as proposed, with one change. We originally
proposed to change the transmission requirements for test OASIS data in
a manner that would bring the regulation in line with current
transmission guidelines that existed at the time when the proposed rule
was published. Specifically, at Sec. 484.45 we proposed to require
that an HHA must, ``Successfully transmit test data to the state agency
or CMS OASIS contractor.'' On January 1, 2015 CMS changed the OASIS
transmission guidelines to require that an HHA must successfully
transmit test data to the Quality Improvement and Evaluation System,
Assessment Submission and Processing, (QIES ASAP) System or CMS OASIS
contractor. We have revised the final rule at Sec. 484.45 to reflect
this change and maintain consistency between the transmission
guidelines and the regulatory requirements.
Comment: One commenter encouraged CMS to address the potential
implications and to coordinate its policies concerning data collection
with the requirements of the IMPACT Act. They specifically mentioned
the call for standardized post-acute care assessment data for quality,
payment, discharge planning and other purposes.
Response: We agree that data collection should be coordinated, and
have undertaken numerous efforts to align data elements across data
sets, where appropriate. On November 5, 2015, we finalized the CY 2016
Home Health Prospective Payment System Rate Update; Home Health Value-
Based Purchasing Model; and Home Health Quality Reporting Requirements
rule (80 FR 68623) that discusses implementation of the requirements of
the IMPACT Act for HHAs. We will be taking steps to implement the
IMPACT act over the next several years, in accordance with its
statutory deadlines.
Comment: Several commenters cautioned CMS on over-reliance on OASIS
to assess home health agency performance and for CMS to address
shortcomings with the OASIS data collection tool. They recommended that
CMS advise home health agencies to utilize available resources that
provide guidance in managing complex health conditions.
Response: While we appreciate these suggestions related to the
OASIS, the content of the OASIS and its use by CMS to assess the
quality of care provided by HHAs are not within the scope of this rule.
HHAs are encouraged to use all appropriate available resources to
manage patient care, such as those available on the CMS OASIS Web site
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/OASIS/index.html?redirect=/OASIS/01_Overview.asp).
Patient Rights
Comment: Many commenters supported the proposed patient rights
requirements, highlighting the patient-centered focus of the proposed
requirements, and stating that such requirements will help achieve
better health and better health outcomes. Conversely, a few commenters
questioned the need for an expanded set of patient rights and stated
that the new requirements would require too many forms. Others stated
that the proposed requirements were repetitive.
Response: We appreciate the support for this requirement, and agree
that it is a useful part of the overall goal to achieve better outcomes
for patients. We do not agree that the new requirement will result in a
greater number of forms per patient, as these changes can be
incorporated into the current patient rights process that HHAs are
already required to have. We also do not agree that the requirements
are repetitive in that each standard addresses a distinct aspect of
patient rights.
Comment: A few commenters suggested that CMS take an active role in
assisting HHAs in complying with the patient rights requirements by
requiring states to develop ombudsman services for home health care
patients to help patients resolve complaints and assist patients who
wish to appeal an HHA's decision to transfer or discharge them.
Commenters also suggested that CMS should create a consumer Web site to
provide information about patient rights in layperson's terms, and that
this Web site should be available in multiple languages.
Response: We appreciate these suggestions; however, they are beyond
the scope of this regulation. Therefore, we are precluded from acting
upon them in this rule. We will retain this suggestion for future
consideration.
Comment: A few commenters suggested that CMS develop standardized
patient rights materials, translated into the languages most commonly
used by Medicare beneficiaries. Commenters also suggested that CMS
should provide the OASIS privacy notice in languages other than English
and Spanish, and that the notice should be written in a way that is
understandable to persons who have limited English proficiency.
Response: The content and format of the OASIS privacy notice are
not within the scope of this rule; however we will retain this
suggestion for future consideration. We do not agree that requiring a
specific patient rights form would benefit HHAs or HHA patients, as the
use of a specific form would reduce HHA flexibility to include
additional HHA-specific information that may be relevant. In addition,
mandating a specific form may interfere with or duplicate the patient
rights information requirements established by states and accrediting
organizations. Therefore, this rule does not require the use of a
specific patient rights form. Rather, HHAs may use a means of their
choosing that conveys the required information. We remind HHAs that
where several regulatory bodies have established standards governing
the same subject matter, we expect HHAs to adhere to the most stringent
requirement. Absent a single mandated notice of patient rights, it is
not possible for CMS to provide translations.
Comment: A commenter requested clarification regarding the
provision of the notice of patient rights. The commenter asked whether
the HHA would be required to deliver notices to (1) both the patient
and the patient's representative, or (2) either the patient or the
patient's representative.
Response: We proposed, and are finalizing a requirement that the
notice of patient rights must be provided to both the patient and his
or her representative. This is particularly

[[Page 4518]]

necessary in situations where the representative legally possesses
health care decision making authority. In situations where the
representative is patient-selected and does not possess legal health
care decision making authority, a patient may choose to decline the
provision of the notice of rights to the patient-selected
representative because the definition of the term ``representative''
explicitly states that the patient determines the role of the
representative, to the extent possible. The patient may choose to
involve or not involve the patient-selected representative regarding
every interaction with the HHA. We would expect an HHA to document in
the patient's record that a patient declined to have a copy of the
notice of rights provided to the representative. We believe that
explicitly allowing patients to choose whether or not the information
is provided to the patient-selected representative will give patients
greater control over their care.
Comment: A few commenters referenced existing statutes and
regulations that relate to the proposed requirements. One commenter
stated that it would be helpful if CMS expressly stated that these
requirements are identical to the requirements under Title VI of the
Civil Rights Act to ensure that there is no discrepancy related to the
standard that will be applied. Another commenter referenced the
National Standards for Culturally and Linguistically Appropriate
Services in Health and Health Care (the National CLAS standards,
https://www.thinkculturalhealth.hhs.gov/content/clas.asp), and stated
that, under these standards, an agency may identify the dominant
languages in its patient population and prepare written materials in
the most frequently spoken languages. Individuals who speak less
commonly encountered languages receive a description of the contents of
the patient rights notice from an interpreter. The commenter asked
whether adherence to the National CLAS standards will meet the intent
of the proposed regulation. The commenter also suggested that we should
revise the regulation requirements at Sec. 484.50(a)(1)(ii) to
specifically allow interpreters to be used to help individuals who
speak a language not commonly found in the agency's service area to
understand the notice of patient rights. Yet another commenter
referenced the Office for Civil Rights (OCR) Guidance at http://www.hhs.gov/ocr/civilrights/resources/specialtopics/lep/hhslepguidancepdf.pdf, which states, ``. . . the starting point is an
individualized assessment that balances the following four factors: (1)
The number or proportion of limited English proficiency (LEP) persons
eligible to be served or likely to be encountered by the program or
grantee; (2) the frequency with which LEP individuals come in contact
with the program; (3) the nature and importance of the program,
activity, or service provided by the program to people's lives; and (4)
the resources available to the grantee/recipient and costs.'' The
commenter suggested that this guidance should be used as the basis for
the regulations.
Response: We appreciate the comments on this subject, but as stated
in the proposed rule, the regulation requirements on this subject are
already consistent with Department of Health and Human Services
guidance regarding Title VI of the Civil Rights Act. We agree that the
National Standards for Culturally and Linguistically Appropriate
Services in Health and Health Care (CLAS) is a good reference, but we
are unable to say with certainty that adherence to CLAS guarantees full
compliance with this rule because each situation is evaluated on its
own merits. In addition, we would like to clarify that regulation
requirements that state documents must be ``understandable'' does not
require or suggest that documents must be written in every language.
Comment: While commenters expressed general support for the concept
of effective communication with patients, a large number of commenters
posed questions regarding the proposed requirement to communicate with
patients in a language and manner that they understand. Commenters
wanted to know if all patient rights documents would be required to be
translated into the patient's preferred language both orally and in
writing. Commenters also requested clarification regarding the
responsibility of each HHA to have written notices in each possible
language the agency may encounter in the community, and asked that CMS
provide a more limited and nationally standardized set of languages in
which such notice must be conveyed. Additionally, commenters suggested
that we should differentiate between ``vital'' and ``non-vital''
patient rights information that would need to be provided, in writing,
in a language and manner that a patient understands, limiting required
written information to what is vital and permitting the communication
of non-vital information to an oral translation. Commenters further
noted the challenges associated with providing a written copy of the
notice of rights in the preferred language at the time of the initial
visit because there are times when an HHA is not aware of the referred
patient's language preference until the visit is initiated. The
commenter suggested that, in such situations, the HHA should be
required to provide the written notice in a reasonable amount of time
(for example, 72 hours). Similarly, a commenter questioned whether an
unforeseen inability to orally inform a patient of his or her rights in
understandable language and manner ``in advance of providing care''
would mean that the clinician performing the initial patient visit
would be prohibited from admitting the patient to services.
Response: We appreciate these comments and realize the task of
requiring agencies to communicate with patients in a language and
manner in which they understand may cause confusion when trying to meet
the regulations in a consistent manner to remain compliant. We do not
have the expectation that HHAs will be presenting a translated patient
rights document to every single patient in their native language when
they are admitted and before they begin receiving care. We want to
emphasize that the term ``understandable'' does not mean it is expected
to be written in every language. A general understanding means that
patients achieve a grasp of the explanation of something and not
necessarily a verbatim written translation. We expect HHAs to utilize
technology, such as telephonic interpreting services and any other
available resources for oral communication in the patient's primary or
preferred language prior to the completion of the second skilled visit.
The flexibility that is built into this requirement, allowing the use
of technology, remote interpretation services, and patient-selected
interpreters should accommodate most situations, alleviating potential
concerns regarding an ``unforeseen inability'' to communicate with
patients in advance of furnishing services. Based on the HHA location,
language needs will vary and often times a document will only have to
be translated once and then can be utilized again as needed without
extra translation burden. In addition, we have revised the requirements
to allow additional time for HHAs to provide oral notification of
rights, removing the requirement that oral notification be provided in
advance of providing care. We believe that this change will also
alleviate concerns regarding an unforeseen inability to orally inform a

[[Page 4519]]

patient of his or her rights in understandable language and manner
preventing the clinician performing the initial patient visit from
admitting the patient to services.
Comment: A commenter requested clarification of the term
``preferred language.''
Response: The Department of Health and Human Services 2013 Language
Access Plan described ``Preferred Language'' as the language that a
limited English proficiency (LEP) individual identifies as the
preferred language that he or she uses to communicate effectively.
Comment: Several commenters submitted comments regarding the role
of patient-selected, rather than professional, interpreters.
Specifically, commenters supported statements in the preamble that
would permit a patient to select his or her own interpreter in lieu of
a professional interpreter. Commenters noted that, even if a patient or
representative does offer to provide an interpreter, she or he should
still be informed of the availability of professional interpretation
services. A commenter requested clarification of the preamble statement
that an HHA ``may wish to document'' the refusal of a professional
interpreter, stating that some surveyors may interpret this suggestion
as a regulatory requirement.
Response: We appreciate these comments of support. We agree that a
patient should be informed of the availability of professional
interpretation services, regardless of whether the patient offers to
provide an interpreter. Section 484.50(c)(12) requires HHAs to provide
written notice, prior to the initiation of care, informing patients
that they have the right to access auxiliary aids and language
services, and how to access these services. Title VI of the Civil
Rights Act does not require documentation, and we do not intend to
require anything above and beyond what is currently required in Title
VI. HHAs have the flexibility to document more information, but it is
not a regulatory requirement.
Comment: A commenter disagreed with the idea that an HHA may
communicate patient rights information to the patient's representative
``if a patient is unable to effectively communicate directly with HHA
staff.'' The commenter asserted that this should only be true in
situations where the patient is unable to participate, to any degree,
in decision making regarding her or his health care. The commenter
stated that if a patient can participate in health care decision
making, it is essential that HHAs offer auxiliary aids, professional
interpretation services, and translated materials directly to the
patient, rather than relying on the representative to serve as an
interpreter.
Response: Our intent is to assure that HHAs communicate directly
with the patient in all situations where the patient has the mental
capacity to participate in and understand such communications. However,
if a patient is unable to effectively communicate and participate in
their care due to a compromised mental capacity as identified through
information provided by referral sources, clinical observations, and/or
clinical assessment, then the HHA is permitted to communicate with the
patient's representative.
Comment: A commenter disagreed with the way we characterized the
role of an interpreter in the preamble of the proposed rule. The
commenter stated that, in addition to our original description, it is
also an interpreter's role to facilitate two-way communication, so that
the patient can describe changes in his or her condition or experience
of care, ask questions, and articulate preferences and concerns.
Response: We agree that an interpreter's role also includes
facilitating two-way communication and patient participation in his or
her care. We encourage communication that will help the patient be an
active participant in his or her care. We emphasize the interpreter's
role in communications from the facility because the facility has a
legal obligation to communicate effectively with the patient or his/her
representative.
Comment: Some commenters agreed, while other commenters disagreed,
with the requirement that the HHA must ensure that the communication
via the interpreter of choice is effective. A commenter stated that
this requirement is impracticable, as by nature of the fact that the
HHA staff is using an interpreter means that staff member is unable to
communicate in the patient's language, rendering the staff member
incapable of ensuring the effectiveness of the communication. Another
commenter recommended that minors should be prohibited from acting as
patient-selected interpreters. This commenter stated that minors lack
clinical knowledge to be effective interpreters, and that performing
interpreter duties may result in minors being exposed to information
that is confusing or frightening to them, especially if they are
interpreting for a parent.
Response: The most reliable way to assure that communication is
effective is to use the services of a professional interpreter who
possesses appropriate training and certifications to perform his or her
job duties as an interpreter. Even so, patients have the right to
choose someone other than a professional interpreter. Absent a
professional interpreter, either because the patient has expressly
declined the use of one or the patient's language is so rare that an
interpreter, whether in person or by communication device such as the
telephone, cannot be located, the HHA may use a patient-selected
interpreter, such as the patient's representative. The patient's
representative, who could be a family member or friend, may act as a
liaison between the patient and the HHA to help the patient
communicate, understand, remember and cope with the interactions that
take place during the visit, and explain any instructions to the
patient that are delivered by the HHA staff. The HHA would be
responsible for verifying that communication to the representative was
effective and accurate communication, which could be accomplished by
having the patient representative repeat back instructions. An HHA
would be expected to observe the interactions between the patient-
selected interpreter and the patient to determine whether the
communication appears to be effective. For example, if a patient
continues to look confused after the information is presented, then the
HHA clinician may conclude that the communication was not effective in
conveying the necessary information. This regulation is consistent with
the current HHS guidance (``Guidance to Federal Assistance Recipients
Regarding Title VI Prohibition Against National Origin Discrimination
Affecting Limited English Proficient Persons,'' 68 FR 47311, August 8,
2003, (https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-federal-financial-assistance-recipients-title-VI/), and the HHA should respect patient preference to
use someone other than a professional interpreter (even after being
offered and denied). If the competency or accuracy of the patient-
selected interpreter is in serious question, for example, the clinician
speaks a paragraph of specific instructions and the interpreter
``interprets'' in a single sentence, the expectation would be to then
bring in the services of a professional interpreter. We agree that the
use of minors to serve as interpreters should be a last resort and only
used in emergency circumstances.
Comment: Several commenters raised concerns about translators,
particularly

[[Page 4520]]

in relationship to less common languages. Commenters requested guidance
on handling situations when an interpreter is not available in the
community. Other commenters requested guidance on the appropriate use
of available technologies that could be used to achieve compliance with
the accessibility requirements in this rule.
Response: We understand these concerns and agree that it is
occasionally difficult to locate an interpreter for certain less common
languages. Compliance with this requirement is achievable if the HHA
takes all reasonable steps and actions to provide meaningful access to
an interpreter as set forth by the HHA guidelines. HHAs are expected to
exhaust all avenues of technology such as telephone translation, video
conferencing, or online translation of written documents. All of those
choices are acceptable options when a local interpreter cannot be
located, provided that the chosen option meets the patient's
communication needs.
Comment: A commenter asked whether the regulation requires HHA
personnel to read the entire content of the notice of patient rights to
the patient or whether it is acceptable to explain the overall intent
and general content of the notice of patient rights without reviewing
the rights verbatim.
Response: The intent of this requirement is for HHAs to thoroughly
discuss the content of the notice of patient rights with the patient
and representative, and to allow patients and representatives an
opportunity to ask questions and otherwise seek clarification regarding
the notice of patient rights. HHA staff members are not required to
read the notice word-for-word to the patient. Rather HHA staff members
have the flexibility to provide comprehensive and accurate summaries of
each right in conversational language and tone in order to engage
patients and representatives in this discussion.
Comment: A large number of commenters submitted comments regarding
the proposed requirement to provide the notice of patient rights prior
to the initiation of care. Commenters expressed concern about providing
a large amount of information (both in paper form and in oral
explanation) at a single visit, and all prior to initiating care.
Commenters stated that this can be overwhelming for patients, and can
result in patients not retaining important information (for example,
how to make a complaint). The commenters suggested a multi-visit
approach to providing information regarding patient rights. Some
commenters suggested spreading the communications regarding patient
rights across two visits, while others suggested a more extended
approach. Commenters suggested that the first visit should include the
information deemed to be essential prior to the initiation of care,
with important, but not essential, information being reviewed during a
subsequent visit. A commenter also suggested that HHAs should be
required to provide the notice of rights whenever the plan of care is
revised or updated, and should be required to obtain the patient's
signature each time this is done.
Response: In accordance with the requirements of section
1891(a)(1)(F) of the Act, HHAs must provide notice in writing to each
patient regarding his or her rights in advance of providing care. We
agree that providing both written and oral notice in advance of
providing care may not be in the best interest of all HHA patients.
Therefore, we are revising the requirements at Sec. 484.50(a) to
require written notice in advance of providing care and oral notice by
the end of the second skilled visit. HHAs must obtain the signature of
the patient or the patient's legal representative to confirm that
written information was received. HHAs may conduct a thorough
conversation with the patient and representative regarding the content
and meaning of the notice of patient rights over the first two visits
by a skilled professional (nurse, therapist, and medical social
worker). We believe that extending the time frame for the oral
explanation of the notice of patient rights and responsibilities will
foster greater patient understanding of those rights, as well as assure
that the conversation does not inappropriately impede the delivery of
patient care. HHAs would still need to document in the patient's
clinical record that they have provided a complete oral explanation of
the notice of patient rights, in addition to the written notice
provided in advance of furnishing care. Documenting oral notice may be
done by obtaining the patient's or representative's signature, or by a
clinical note.
Comment: A commenter expressed concern with the proposed
requirement that the HHA must provide the patient and the patient's
representative (if any) with written and verbal notice of the patient's
rights and responsibilities during the initial evaluation visit, in
advance of care being provided to the patient. The commenter noted that
a patient-selected representative may not be available or identified at
the initial visit. Furthermore, the commenter stated that requiring the
provision of written and verbal notice of patient rights to the
representative in situations where a patient is competent may serve to
postpone the initiation of patient care, and negatively impact patient
health and safety. The commenter suggested that the requirements of
Sec. 484.50(a) should be clarified to allow for a patient's
representative to receive a written notice of the patient's rights upon
admission or as soon thereafter in situations when the patient is
competent to make his or her own decisions.
Response: If a patient has a legally appointed or designated
representative that has health care decision making authority, the HHA
must provide notice of the patient's rights prior to initiating care.
Notifying the individual with legal health care authority cannot be
postponed. However, we agree that providing notice to patient-selected
representatives that do not have legal health care decision making
authority is not always necessary prior to the initiation of care. As
stated previously, a patient may choose to decline the provision of the
notice of rights to the patient-selected representative. We believe
that HHAs would choose to document this in the patient's record in
order to demonstrate compliance upon survey. If the patient does not
decline to have the patient-selected representative be informed, and
such representative is not present at the time of care initiation, an
HHA may provide a copy to the patient-selected representative within 4
business days of initiating care. This information can be provided by
mail or electronic means. We have revised the regulatory text at Sec.
484.50(a) accordingly.
Comment: Some commenters strongly supported the proposed
requirement to provide each patient with contact information for the
HHA's administrator. A commenter stated that it would be appropriate to
provide contact information for the administrator, as well as the
administrator's designee, to meet the requirement. The administrator is
not always available, so naming an alternate contact at the agency
would facilitate more efficient and timely response to patient
complaints or questions. However, a commenter suggested that an
administrator should be responsible for receiving complaints, but not
for answering routine patient questions that may be more appropriate
for clinical staff and clinical managers. Other commenters suggested
that it would be more appropriate to provide contact information for
the HHA's 24-hour on-call service number or the HHA's general contact
information.

[[Page 4521]]

Response: We agree that routine patient questions may be more
appropriate for clinical staff and clinical managers; therefore at
Sec. 484.50(a) we have removed from the regulation text the
requirement for the administrator to receive questions. The requirement
that the administrator receive complaints remains in the regulation
because we believe this is an essential leadership function. We also
agree that providing contact information for the 24 hour call line
would be appropriate for answering patient questions; however we do not
believe that this is necessary to require in regulation. HHAs may
choose to incorporate this information, but would not be required to do
so. Similarly, HHAs may choose to include contact information for the
administrator's designee, but would not be required to do so.
Comment: A commenter questioned the necessity of requiring an HHA
to provide each patient with a copy of the OASIS privacy notice, given
that patients are also provided the Health Insurance Portability and
Accountability Act (HIPAA) privacy statement. The commenter stated
that, if the point of the OASIS privacy notice is to advise the patient
why the OASIS is being collected, this information can be more simply
stated and incorporated elsewhere.
Response: As stated in the June 18, 1999 notice related to the
implementation of the OASIS data set (64 FR 32984 through 32989), HHA
patients whose data will be collected and used by the federal
government must receive a notice of their privacy rights. These rights
include: (1) The right to be informed that OASIS information will be
collected and the purpose of collection; (2) the right to have the
information kept confidential and secure; (3) the right to be informed
that OASIS information will not be disclosed except for legitimate
purposes allowed by the Federal Privacy Act; (4) the right to refuse to
answer questions; and (5) the right to see, review, and request changes
on their assessment. The statements of patient privacy rights with
regard to the OASIS collection (one for Medicare/Medicaid patients, one
for all other patients served by the HHA) are included in the OASIS
privacy notice. Many of the topics addressed in the OASIS privacy
notice are not included in the HIPAA (Pub. L. 104-191, 110 Stat. 1936,
enacted August 21, 1996) privacy statement. Therefore, we do not
believe that the HIPAA privacy statement is an appropriate substitution
for the OASIS privacy notice, and we are maintaining the requirement
that HHAs must provide patients with both the HIPAA privacy statement
and the OASIS privacy notice.
Furthermore, we believe that the content of the OASIS privacy
notice is understandable to patients. As explained in the June 1999
notice, consumer testing was undertaken to determine whether Medicare
beneficiaries understood the overall message of the proposed Medicare
notice. The findings indicated that beneficiaries understood that the
notice was informing them about their rights relating to their personal
health care information and that these protections were good. In
addition, the majority of the beneficiaries found the notice's language
to be clear and easy to understand.
Comment: Most commenters supported the patient-centered, patient-
directed approach used in relationship to the role of the patient
representative, and several commenters offered suggestions for ways to
implement or clarify this role. A commenter suggested that HHAs should
build a conversation focused specifically on patient representation
into every admission visit. This conversation would allow the patient
to identify those person(s) with whom the agency may discuss their
care, or not discuss their care. The agency would document this in
whatever format is most appropriate for them (for example, the
electronic medical record (EMR)) and that would guide future
conversations. In addition, the commenter suggested that HHAs should
provide patients with written information, as part of the patient
rights information, that would inform the patient that he or she can
choose representatives, and make changes to that choice at any time by
contacting HHA staff. Another commenter suggested that, in order to
comply with the proposed requirement to allow patients to select their
representatives, HHAs would need to create timeframes for contacting
representatives, maintain documentation of patient preferences,
maintain documentation of contacts with representatives, and actually
involve representatives in care planning. Another commenter suggested
that HHAs should be required to establish a primary contact to which
all communication will be directed concerning the patient. That person
would receive all information regarding the patient's rights, plan of
care, and discharge plan updates.
Response: We appreciate all of the suggestions, and believe that
they are examples of best practices that an HHA may consider adopting
in order to facilitate compliance with the written regulations and
spirit of the rule.
Comment: A few commenters suggested changes to the wording used to
describe competency as it relates to rulings under state law.
Commenters stated that the regulation should include other designations
made under state law short of adjudication of ``incompetence.'' In
place of the term ``incompetence,'' commenters suggested that we use
the phrase ``lack legal capacity.'' Commenters also suggested that, if
a state court has not adjudged a patient to lack legal capacity, the
patient's representative should be permitted to exercise the patient's
rights, but doing so must be in accordance with state law and with the
patient's permission.
Response: While we believe that ``incompetence'' is a legally
appropriate term, we agree that there are degrees of competence and
incompetence, and that the term ``incompetence'' may not adequately
express the exact degree that we originally intended to convey. For
this reason, at Sec. 484.50(b) we have replaced the term
``incompetence'' with the more precise phrase ``lack legal capacity to
make health care decisions as defined by state law.'' The extent to
which patients who possess legal capacity to make their own health care
decisions choose to delegate that decision making authority to others
would be established by the patient, as recognized in the definition of
the term ``representative.'' The definition at Sec. 484.3 states that,
``the patient determines the role of the representative, to the extent
possible.'' HHAs are encouraged to engage patients in a thoughtful
discussion about the representative role that the patient desires. HHAs
may find resources related to supported health care decision making
agreements helpful in creating a framework for and documenting the
results of these discussions. (See http://autisticadvocacy.org/wp-content/uploads/2014/07/ASAN-Supported-Decisionmaking-Model-Legislature.pdf for one example of a supported health care decision
making agreement.)
Comment: A commenter suggested that the patient or his or her
representative should have the right, upon an oral or written request,
to inspect all records pertaining to himself or herself including
current clinical records within 48 hours (excluding weekends and
holidays); and to receive copies of electronic records free of charge
or to purchase, at a cost not to exceed the community standard,
photocopies of the records or any portions of those records with 2
working days of the HHA receiving the request.

[[Page 4522]]

Response: We agree that patients and/or representative have the
right to request a copy of their clinical record. Patients may access
their records in accordance with Sec. 484.110(e), which requires that
a patient's clinical record (whether hard copy or electronic form) must
be made available to the patient upon request, free of charge, at the
next home visit, or within 4 business days (whichever comes first).
Comment: A commenter stated that it is redundant to require that
HHAs must assure that patients receive services in a manner that is
free from illegal actions, such as sexual abuse or physical abuse.
Response: We do not agree that it is redundant because the
enforcement mechanisms for criminal statutes and these CoPs are very
different. While certain actions, such as misappropriation of patient
property (theft) are illegal, HHA surveyors do not enforce criminal
statutes. However, we do believe that the HHA has a responsibility to
ensure that no illegal activity takes place, and should be penalized if
it does not take all necessary precautions to prevent its staff from
engaging in criminal activity. If this requirement at Sec. 484.50(c)
were removed, an HHA surveyor would have no mechanism to cite an HHA
for criminal acts committed by its staff. Therefore, we believe that it
is in the best interest of HHA patients to include this requirement and
enable an HHA surveyor to issue a deficiency citation for non-
compliance.
Comment: A commenter stated that the patient's right to participate
in, be informed about, and consent or refuse care in advance of and
during treatment, where appropriate, with respect to factors that could
impact treatment effectiveness is not a reasonable expectation in all
cases.
Response: We disagree with this comment. A patient's right to be
informed about care, and to consent or refuse any element of that care,
is fundamental. Furthermore, where internal or external factors exist
that may impact the effectiveness of a given treatment option, we
believe that it is a reasonable expectation that they would be
discussed with a patient in advance so that the patient can make an
informed decision about the care they are set to receive.
Comment: A commenter opposed the proposed requirement that a
patient has the right to participate in, be informed about, and consent
or refuse care in advance of and during treatment, where appropriate.
The commenter opposed the phrase ``where appropriate,'' stating that
there are no circumstances where it would not be appropriate for a
patient to participate in, be informed about, and consent or refuse
care in advance of and during treatment. The commenter also stated that
the term ``appropriate'' is subjective and would be defined by the HHA,
possibly resulting in limiting or even eliminating a patient's right to
be involved in his or her care.
Response: While we agree that patients have these fundamental
rights, and that those rights should be guaranteed in regulation, the
phrase ``where appropriate'' is necessary. The patient has the right to
determine the degree to which he or she wants to be involved in his or
her care, and the use of this phrase reflects the fact that each
patient will determine what is or is not appropriate in his or her own
way. We believe that most patients will not want to be involved in
every specific detail of care (for example, the type of supplies used).
Thus, these decisions would likely not require full explanation to, and
discussion with, the patient. To mandate the right to participate in,
be informed about, and consent or refuse care in advance of and during
treatment, for every single decision made by an HHA would be burdensome
to patients that have no interest in such a degree of participation,
and contrary to the goal of delivering care efficiently.
Comment: A commenter suggested that patients should have the right
to participate in, be informed about, and consent or refuse care in
advance of and during treatment with respect to the timing of visits
and who provides services.
Response: These concepts are already included in Sec.
484.55(c)(2), which requires the HHA to assess each patient's care
preferences, and Sec. 484.60, which requires that the individualized
plan of care be based on the assessment of the patient.
Comment: A commenter suggested that, rather than requiring that a
patient has the right to be informed about the patient-specific
comprehensive assessment, the regulation should require that a patient
has the right to be informed about all assessments throughout the
course of care. The commenter stated that patients and caregivers may
want to know the findings of any given assessment, rather than just the
comprehensive assessment, which is performed at specified periods of
time.
Response: We agree that the HHA's patients should be informed
about, and consent or refuse care in advance of and during treatment,
where appropriate, with respect to all patient assessments, rather than
just the ``comprehensive assessment.'' We have revised the regulation
text at Sec. 484.50(c)(4)(i) to reflect this change.
Comment: A commenter recommended that a patient's right to be
involved in establishing and revising the plan of care should be
limited to involvement in major revisions to the plan of care, such as
a change in the goal of care, the number of visits, or discharge date.
Response: The intent of this requirement is to assure that HHA
patients can be informed about and involved in establishing and
revising their plan of care as a whole. We believe the patient has a
right to be involved with all facets of the care they receive. It is
the HHA's responsibility to discuss the level of involvement that
patients and their representatives want to have in the plan of care.
This would include factors such as how much the patient is capable of
understanding and the extent they wish to be involved with the
development and updates to the plan of care. HHAs should make all
reasonable attempts to respect patient wishes.
Comment: The majority of commenters expressed concern regarding the
proposed requirement that an HHA must provide a patient with a copy of
his or her plan of care. While some commenters agreed with our position
that providing a patient with information about his or her plan of care
would improve patient understanding and compliance, most stated that,
as a clinically oriented document for use by medical personnel, the
plan of care is not created in a manner that would make sense to a
patient. Some commenters stated that patients would not want
information about their plan of care, and noted that all patients
already have a right to request copies of medical records, while other
commenters stated that patients would prefer to receive this
information. A few of these commenters suggested that the plan of care
should be required to be provided if the patient desires it or
specifically requests it. A single commenter sought reassurance that
the copy of the plan of care would be provided at no charge to the
patient. Still other commenters requested additional clarification
regarding the meaning of the term ``plan of care'' as it is used in
this section. These commenters stated that ``plan of care'' could mean
general items the patient, home health clinicians, and physician agree
the patient will be working on, or, it could mean all the physician
orders, medications, etc. Some commenters suggested that HHAs should be
required to provide each patient with an abbreviated plan of care, also
referred to as a care plan summary, as a distinctive product
specifically designed to engage

[[Page 4523]]

patients, their caregivers, and representatives as partners in
treatment and care. Commenters suggested the following elements for
this product: Patient condition, goals of care and measurable outcomes
that the agency and patient have identified, a list of homecare
services to be provided, specific training and interventions designed
to prevent the need for emergency department care and hospitalization,
a visit calendar for each discipline involved in the patient's care,
and any other information that is necessary to improve the patient's
health.
Response: We appreciate the many thoughtful comments that were
submitted on this subject. We agree with the large majority of
commenters that the plan of care (as set forth in Sec. 484.60(a)) is a
clinically oriented document that is written in medical terminology and
in a manner that may not be comprehensible to the majority of HHA
patients. For this reason, we agree that it is not appropriate to
require HHAs to routinely provide each patient with a copy of his or
her plan of care and we have removed this requirement from the
regulation at Sec. 484.50(c). However, HHAs are still required to
provide any information contained in the clinical record, including the
plan of care, free of charge, upon request from the patient, in
accordance with the requirements of Sec. 484.110(e). While we see the
potential benefit of requiring HHAs to prepare and provide a plan of
care summary to each patient, and believe that patients should be able
to easily access information pertinent to their care, we do not believe
that the significant burden that would be imposed with such a
requirement is justified at this time. Currently many HHAs do not
possess the technology, such as electronic medical records with secure
patient portals, to make implementation of a plan of care summary
requirement feasible. We will consider a plan of care summary
requirement in the future based on the evolving use of technology in
the HHA environment. While the plan of care described in this rule is
focused on services delivered by the HHA, we also note that the concept
of a ``plan of care'' continues to evolve, and future ``plans of care''
are likely to be more comprehensive documents that reflect the care
patients receive across settings. As plans of care become more
comprehensive, the importance of ensuring patients have access to this
document will also increase. It is important to note that HHAs are
still required to involve patients in the actual development and
updating of the plan of care as required by Sec. 484.50(c) and Sec.
484.60(c).
In addition, in response to comments requesting that CMS require
that written clinical and educational information be made available to
HHA patients and caregivers, we have added a new standard at Sec.
484.60(e), ``Written information to the patient.'' The new provision,
which partially replaces other requirements previously placed
elsewhere, requires the HHA to provide written instructions to the
patient and care giver outlining visit schedule including frequency of
visits, medication schedule/instructions, treatments administered by
HHA personnel and personnel acting on the behalf of the HHA, pertinent
instructions related to patient care and the name and contact
information of the HHA clinical manager. We believe that these
requirements will ensure that patients are actively engaged in their
own care. In addition, HHAs may use any form of communication (for
example, typed summaries, checklists, calendars, handwritten notes,
secure electronic communications, or orientation videos) to facilitate
patient knowledge and understanding of the care being provided.
Providing patients and caregivers written instructions that they may
refer to between visits is critical to both the quality and safety of
patient care.
Comment: Many commenters sought clarification regarding the format
for providing a copy of the plan of care to each patient. Specifically,
commenters questioned whether the plan of care could be provided via
electronic means, such as a secure patient portal. A few commenters
suggested that the regulations should only require information to be
communicated to patients orally, rather than in written form.
Commenters also sought clarification regarding the timing for providing
a copy of the plan of care. Commenters questioned whether the plan of
care needed to be signed by the physician before being provided to the
patient. Commenters also stated that requiring that patients be
immediately provided with a hard copy of their plan of care would be
extremely difficult in the current system of electronic medical record
(EMR) reliance, and urged that HHAs be allowed to mail a copy of the
plan of care within 24 hours of any actions that necessitate the copy
to be shared. Commenters also suggested that HHAs be permitted to
deliver the copy of the plan of care either to the patient or to the
patient's representative. Numerous commenters requested additional
information about the proposed requirement to provide each updated
version of the plan of care to each patient. Commenters questioned
whether updates could be delivered electronically by email or other
secure electronic means to the patient or to the patient's
representative. Other commenters sought clarification about the types
of updates that would be required to be communicated to patients.
Specifically, one commenter stated that in the preamble to the proposed
rule, we explained that an HHA would need to notify a patient when the
individualized plan of care is updated due to a significant change in
the patient's health status. However, the text of the proposed
regulation did not include the word ``significant,'' making it appear
as if slight changes in patient status that result in tweaks to the
plan would require notice. The commenter stated that we should include
the word ``significant'' in the final regulation. Commenters offered
suggestions regarding changes that would be significant, such as a
change in therapy from physical to occupational therapy, with new
caregivers coming to the home, or a change in medication, versus
changes that would not, in the commenter's opinion, be significant,
such as a change in visit frequencies or a change in medication dose.
Commenters also requested flexibility in the format for providing
notice, such as providing updates to the plan of care orally, with a
notation in the patient's clinical record to document this oral
communication. In addition to providing oral communication of changes
to the plan of care, one commenter suggested that, if the change of
plan of care involves teaching the patient skills to improve their
medical treatment, the HHA should provide written information, such as
flyers, that would help the patient remember and follow what they were
taught. Another commenter suggested that HHAs should be required to
manually update the copy of the first plan of care whenever there is a
change or new order, and then furnish a clean, current copy of the plan
of care upon request by the patient or representative, or whenever it
is apparent that the patient's copy is missing, incomplete,
inconsistent, or difficult to clearly read or follow.
Response: For the reasons set forth above, as well as in light of
the many logistical concerns raised by commenters, we have revised the
regulation at Sec. 484.50(c) to remove the requirement that HHAs must
routinely provide a copy of the plan of care to each patient. HHAs must
involve patients in the development and

[[Page 4524]]

updating of the plan of care to the degree that a patient chooses to be
involved in this process. HHAs are permitted to use any form of
communication (for example, typed summaries, checklists, calendars,
handwritten notes, secure electronic communications, or orientation
videos) to facilitate patient knowledge and understanding of the care
being provided.
Comment: A few commenters expressed concern regarding the
information security of leaving a copy of a patient's plan of care in
the home. The commenters were concerned that potentially sensitive
information, such as substance use[hyphen]related diagnoses, may be
included on the plan of care, and potentially disclosed in the act of
leaving a copy of the plan of care in the patient's home. A commenter
also stated that it would be burdensome to require HHAs to educate
patients and caregivers regarding the proper handling of sensitive
information. The commenter stated that patients and caregivers, not
HHAs, are in the best position to determine where this information
should be kept and who sees it.
Response: We appreciate the thoughtful comments regarding sensitive
patient information. For the reasons set forth above, we have revised
the regulation at Sec. 484.50(c) to remove the requirement that HHAs
must routinely provide a copy of the plan of care to each patient. HHA
patients retain the right to request a copy of any information
contained in the patient's clinical record, including the plan of care.
It is the HHA's responsibility to ensure proper and appropriate
education is provided to the patient regarding protecting their own
healthcare information. We do not agree that patient education
regarding protection of the plan of care is any different than the
patient education that is already provided regarding protection of
other information that HHAs routinely leave in the patient's home (for
example, aide visit calendars and patient rights information);
therefore there would not be an additional burden for this activity.
Rather, it is part of the cost of doing business. Teaching patients to
secure their personal healthcare information is basic information that
can be shared when giving the HHA contact information, policies and
procedures and plan of care in the initial phase of care. Patients and
their representatives have the ultimate responsibility to decide how
and where information will be kept in the home.
Comment: Many commenters were concerned with the burden that would
be placed upon HHAs in providing each patient with a copy of his or her
plan of care, as well as updates to that plan of care.
Response: For the reasons set forth above, as well as in light of
the many logistical and burden-related concerns raised by commenters,
we have revised the regulation at Sec. 484.50(c) to remove the
requirement that HHAs must routinely provide a copy of the plan of care
to each patient.
Comment: A few commenters asked for clarification about providing a
copy of the plan of care in relation to the requirement to communicate
with patients in a manner that they understand. Specifically,
commenters wanted to know whether the plan of care would need to be
provided in the language the patient is most comfortable with, whether
it would need to be understood at a 6th grade level, and whether it
would need to be provided in a format that accommodates individuals
with disabilities.
Response: For the reasons set forth above, as well as in light of
the many logistical concerns raised by commenters, we have revised the
regulation at Sec. 484.50(c) to remove the requirement that HHAs must
routinely provide a copy of the plan of care to each patient. HHAs are
permitted to use any form of communication (including, but not limited
to, typed summaries, checklists, calendars, handwritten notes, secure
electronic communications, and orientation videos) to facilitate
patient knowledge and understanding of the care being provided. Should
an HHA provide a written document to a patient, we would expect that
document to be understandable to the patient in accordance with the
requirements of Sec. 484.50(f). As clarified above, the term
``understandable'' means that patients achieve a grasp of the
explanation of something and not necessarily a verbatim written
translation. We expect HHAs to utilize technology, such as telephonic
interpreting services and any other available resources for timely oral
communication in the patient's primary or preferred language.
Comment: While some commenters agreed with the proposed requirement
that a patient would have the right to participate in establishing the
goals of care, other commenters identified some concerns with this
concept. Commenters observed that patients may not understand the
concept of establishing measurable goals of care, may have unrealistic
goals, or may have goals that are inconsistent with other goals of
care. One commenter requested guidance on how to comply with this
proposed requirement when the patient-identified goals are unclear or
unrealistic, while another commenter suggested that in these cases an
HHA should document the reason that the patient's goal cannot or should
not be accommodated.
Response: We appreciate the thoughtful comments. Regardless of
whether a patient can verbalize their goals, all patients have goals
even if it is as basic as feeling better today than they did yesterday.
It is part of the HHA's responsibility to help patients form and shape
achievable goals that are relevant to the delivery of the HHA care they
receive. There may be times when a patient's goal may be contrary to
the HHA healthcare goals. For example, a patient may wish to walk
outside unattended, but if the patient has serious cognitive
impairment, they may be at risk for wandering. We believe the HHA is
capable of discussing realistic goals with their patients and
documenting why a specific goal may not be appropriate. As part of the
re-directing process with the patient, the HHA is able to identify more
appropriate goals that are achievable.
Comment: A few commenters sought clarification regarding the
proposed patient right to refuse services. Commenters sought to
understand the scope of this right, asking questions such as whether
this right is meant to cover minor situations, such as refusing to have
their hair washed on a particular day because of feeling ill, or more
significant refusals such as the refusal of all services. Commenters
stated that, if a patient's refusal relates to a significant part of
the recommended care, the home health agency is faced with determining
whether continued home care is reasonable and necessary for claims
billing purposes or whether the home health patient should be
discharged. Commenters stated that further guidance in this area would
be appreciated.
Response: Patients have always had the right to refuse services.
Although this is the first time that we are including such a right
within the regulations, it is not a new concept. We expect HHAs to
already have policies and procedures in place to address these
situations. If a patient refuses something minor, such as declining a
bath due to fatigue that day, we would expect the HHA to document this
in the clinical record. If the patient or patient representative
refuses large aspects of care (such as dressing changes or essential
medications), then the HHA has the responsibility to document this in
the clinical record and communicate with the patient regarding
implications of the refusal. The HHA would also

[[Page 4525]]

need to communicate with the physician(s) responsible for the plan of
care regarding the refusal of one or more large aspects of care that
have the potential to compromise the HHA's ability to safely and
effectively deliver care to the extent that the HHA can no longer meet
the patient's needs, and discuss the options with the physician(s). The
HHA may need to consider discharge if the patient's refusal of services
compromises the HHA's ability to safely and effectively deliver care to
the extent that that the HHA can no longer meet the patient's needs. We
would expect HHAs to advise the patient, the representative (if any),
the physician(s) responsible for issuing orders related to the
element(s) of the plan of care that are refused, and the patient's
primary care practitioner or other health care professional who will be
responsible for providing care and services to the patient after
discharge from the HHA (if any) that a discharge is being considered.
HHAs should also provide the patient and representative (if any) with
contact information for other agencies or providers who may be able to
provide care in a manner that is consistent with the patient's
preferences.
Comment: A commenter suggested that the regulation should clearly
state that representatives and caregivers have a right to be involved
in establishing the goals of care and care preferences.
Response: This is an enumeration of the patient's rights. Legal
representatives with health care decision making authority make
decisions on behalf of the patient, and would therefore already have
the right to establish the goals of care and care preferences on the
patient's behalf. Additionally, if a patient has authorized a patient-
selected representative to make decisions on his or her behalf, this
individual would have the authority to establish the goals of care and
care preferences. We believe that these flexibilities are sufficient to
assure that representatives are able to represent the interests of
patients. As an enumeration of the rights of the patient, we do not
believe that it would be appropriate to set forth the distinct rights
of the caregiver. It is a best practice for HHAs to take caregiver
goals and preferences into account, but it is not a regulatory
requirement.
Comment: A few commenters questioned the need for regulations that
would enforce a patient's right to receive all of the services included
in the plan of care. Additionally, a commenter expressed concern with
this requirement in relation to specific service coverage limitations
that may be imposed by payment sources.
Response: We believe it is absolutely necessary to include in
regulations the right for the patient to receive all services outlined
in the plan of care. Since HHAs and physicians are responsible for the
items and services included in the plan of care, we presume they will
only include those items and services that are covered by the patient's
payment source or that the patient is willing to pay for.
Comment: A commenter suggested that HHAs should not be required to
inform patients regarding the health hotline and patient liability for
payment.
Response: These are statutory requirements for HHAs set forth at
1891(a)(1)(G) and (E), respectively, of the Act. Thus, it is
appropriate and necessary to include these requirements in the HHA
regulations.
Comment: Many commenters requested clarification regarding the
proposed requirement that an HHA include contact information for local
federally-funded and state-funded consumer information, protection, and
advocacy agencies. Many of these commenters requested flexibility to
determine, based on their patient population, which organizations would
be most appropriate to meet this requirement. Commenters also stated
that HHAs should not be required to assure that this list is
exhaustive. Other commenters suggested that CMS should provide a set
list of agencies to be included in the notice that is provided to
patients. A commenter suggested that any organizations or agencies that
are included on any list should be capable of substantive initial and
follow-up services. Another commenter suggested that the list should
include the local Center for Independent Living, transportation broker,
and housing authority. Some commenters noted potential difficulties
with this requirement, stating that it could be difficult to maintain
the list as organizations and agencies continue and discontinue
operations, relocate, etc. A commenter suggested that HHAs should be
required to prepare and update the list annually. Furthermore,
commenters noted that a universal list may not meet the needs of
different patient populations. Commenters also stated that not all
communities may be able to provide these types of services. Still other
commenters stated that the requirement was unnecessary because nurses
and social workers are available in HHAs to direct patients to the
resources that suit their needs. Instead, commenters suggested that CMS
should require that HHAs maintain accurate and up-to-date lists of
local, state, and federal support and services agencies available to
agency patients in the area where they reside.
Response: We agree that HHAs should have flexibility to include, at
their discretion, those national, state and local resources that would
appropriately meet the needs of their patient population. At the same
time, we also agree that there needs to be a minimum set list of
organizations and entities that all patients will receive. Therefore,
we are finalizing a requirement at Sec. 484.50(c) that an HHA must
provide the names, addresses, and telephone numbers for the regional
Agency on Aging (defined in section 102 of the Older Americans Act of
1965 (42 U.S.C. 3002), http://aoa.acl.gov/AoA_Programs/OAA/How_To_Find/Agencies/find_agencies.aspx), Center for Independent Living (as defined
in section 702 of the Rehabilitation Act of 1973 (29 U.S.C. 796a),
http://www.ilru.org/projects/cil-net/cil-center-and-association-directory), Protection and Advocacy Agency (http://www.ndrn.org/en/ndrn-member-agencies.html), Aging and Disability Resource Center (as
defined in section 102 of the Older Americans Act of 1965 (42 U.S.C.
3002), http://www.adrc-tae.acl.gov/tiki-index.php?page=ADRCLocator),
and Quality Improvement Organization (as set forth at sections 1152
through 1154 of the Social Security Act, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityImprovementOrgs/index.html?redirect=/QualityImprovementOrgs/)
that serves the area where the patient resides. These federally- and
state-funded community-based services and organizations provide care
for patients who are returning home or who want to avoid
institutionalization entities, and are required by federal statute to
help connect individuals to community services and supports. HHAs that
choose to provide the names, addresses, and telephone numbers of
additional organizations and entities may find the Eldercare Locator at
http://eldercare.gov/Eldercare.NET/Public/Index.aspx to be useful, both
as a reference for HHAs and as a reference to be provided to patients
and their representatives.
Comment: A commenter stated that patients should be counseled on
their right to access auxiliary aids and language services, and how to
access those services.
Response: Section 484.50(c)(12) of the final rule states that
patients have the

[[Page 4526]]

right to be informed of the right to access auxiliary aids and language
services, and of how to access these services. We believe that this
information would be included in the written notice of patient rights
that is understandable to the patient. Additionally, HHAs are required
to orally discuss the content of the notice of rights, and we believe
that this oral discussion is sufficient to meet patient needs.
Comment: Some commenters requested clarification regarding the
proposed requirement that an HHA provide a patient with information
regarding the HHA's admission, transfer, and discharge policies.
Specifically, commenters wanted to know whether the proposed
requirement means that the policies must be provided to the patient, or
that the HHA must notify the patient that such policies exist and are
available upon request. Commenters also wanted to know if this
information would be required to be provided orally or in writing.
Finally, commenters requested clarification regarding how this
requirement would be enforced in the survey process.
Response: HHAs are required to provide physical or electronic
documents for the patient's keeping that outline the acceptable reasons
for discharge or transfer, as set forth in 42 CFR 484.50(d)(1) through
(7). We agree that disclosure of admission policies is not necessary as
the patient would already be admitted to the HHA before any such
disclosure would take place, rendering the disclosure unnecessary.
Therefore, we have revised the regulation at Sec. 484.50(d) to clarify
that only those discharge policies set forth in this rule need to be
included in the notice. We expect that verification of distribution of
this notice would be incorporated into a home visit made by a state
surveyor.
Comment: A commenter suggested that we should add the following
requirement to the patient rights CoP: An HHA must ensure that a
patient is transferred or discharged to a setting in which he or she
will receive the level and type of care needed and make every effort to
honor a patient's preferences and choices. A transfer or discharge may
not occur until care in an appropriate setting is obtained. The HHA
must provide sufficient preparation and orientation to patients to
provide for a safe and orderly transfer or discharge from the HHA.
Response: HHAs have the responsibility of coordinating the
discharge and transfer plan to the greatest degree possible to assure a
smooth transition in accordance with patient preferences. We agree that
proper planning and thorough patient preparation is an important part
of a smooth transfer and discharge process. The patient,
representative, caregivers, follow-up care practitioner, etc. are
required to be informed of changes to the transfer or discharge plans
in accordance with the requirements of Sec. 484.60(c)(3)(ii), and we
believe this would be an appropriate time for HHAs to prepare patients
for a transfer and discharge. However, we note that HHAs cannot control
the availability and quality of post-discharge or post-transfer care
and should not be held responsible for those elements that are beyond
their control.
Comment: A few commenters submitted comments related to patient
involvement in the discharge or transfer process. Some commenters
suggested that the HHA should be required to provide written notice of
potential discharge or transfer to the patient, as well as the
caregiver or representative (as appropriate), at least 30 days in
advance of discharge or transfer. Furthermore, a commenter suggested
that the written notice should be required to include the following:
The reason for transfer or discharge;
The effective date of transfer or discharge;
The location to which the patient will be transferred or
discharged;
A statement that the patient has the right to appeal the
HHA's decision to transfer or discharge him or her; and
The address and telephone number of any agency/program
that can represent the patient at a hearing, including but not limited
to, the local office of the Legal Services Corporation; the state
protection and advocacy system; and the local long-term care ombudsman
if the state long-term care ombudsman program is authorized to serve
home care clients.
Additionally, a commenter suggested that HHAs should be required to
notify the State Survey Agency and Medicare contractor of its intention
to discharge for cause. Another commenter requested clarification
regarding whether patient consent is required for transfer. A commenter
suggested that the regulation should include a specific process for
patients to follow if they disagree with the HHA's decision to
discharge or transfer.
Response: We believe the commenters' concerns are sufficiently
addressed by Sec. 484.60(c)(3)(ii), which requires that any revisions
related to plans for the patient's discharge must be communicated to
the patient, representative, and caregiver(s). This is sufficient to
assure appropriate communications between the HHA and the patient,
representative, and caregiver(s) regarding transfer or discharge plans.
Specifically, we do not believe a thirty day notice of transfer or
discharge is a practical requirement for HHAs at this time. HHA
discharges can occur in much shorter timeframes for a variety of
unavoidable reasons ranging from a patient's decision to transfer to
another HHA to a patient's transfer to an acute care provider to a
situation in which HHA personnel are unable to deliver care due to an
unsafe home environment.
Comment: A few commenters suggested additional circumstances under
which HHAs should be permitted to discharge a patient. The commenters
suggested the following additions:
The HHA experiences a staffing change (unexpected staffing
shortage); and
The coverage requirements (that is, the face-to-face
encounter) have not been met.
Response: We do not agree that staffing changes would be an
appropriate reason for patient discharge. HHAs are responsible for
assuring adequate staffing at all times to consistently meet the needs
of all patients under their care. Likewise, we do not agree that it is
necessary to add a reason for discharge specifically related to
coverage requirements. In the event that coverage requirements are not
met, an HHA would be permitted to discharge a patient because the
patient or payer will no longer pay for the care (Sec. 484.50(d)(2)).
We believe that situations where an HHA patient does not meet Medicare
coverage requirements due to a failure to complete the face-to-face
encounter requirements should be exceptionally rare, as we have made
considerable efforts to streamline the requirements related to the
face-to-face encounter coverage requirement and there is ample time (a
120 day period) to complete this coverage requirement. We expect HHAs
to facilitate and coordinate efforts of the patient and physician to
ensure that the face-to-face encounter occurs timely. In the case where
the face-to-face encounter requirement is not met, an HHA cannot hold a
patient financially liable for services provided. Failure to meet a
condition for payment is not one of the criteria where an HHA can hold
a patient financially liable. Once a patient is admitted, an HHA cannot
abruptly discharge a patient unless the patient is properly notified
and there is a valid reason for discharge. Ideally, a face-to-face
encounter, as part of the

[[Page 4527]]

certification process, would occur before the patient received
services.
Comment: A few commenters made suggestions regarding the entities
to which patients are discharged. One commenter suggested that, in
addition to requiring an HHA to discharge a patient to a suitable
source of care, the regulation should also address situations where the
patient refuses further placement or care from another entity. The
commenter stated that patients have the right to refuse follow-up
services. Another commenter suggested that HHAs should not be required
to ``ensure'' a safe and appropriate transfer to another care entity
because HHAs are not in control of other healthcare providers and
cannot guarantee that another agency will take a patient under care.
Response: We appreciate these comments. All HHAs are required to
ensure that appropriate arrangements for transfer are made for those
patients whose acute care needs cannot be met by the HHA, and we have
revised the final regulation at Sec. 484.50(d)(1) to clarify this
responsibility. The Improving Medicare Post-Acute Care Transformation
Act of 2014 (IMPACT Act) (Pub. L. 113-185) requires HHAs to take into
account patient goals and preferences in discharge and transfer
planning. On November 3, 2015, we published a proposed rule, ``Medicare
and Medicaid Programs; Revisions to Requirements for Discharge Planning
for Hospitals, Critical Access Hospitals, and Home Health Agencies''
(80 FR 68126), that would implement this section of the IMPACT Act. The
HHA patient has the right to refuse a transfer to any provider or
supplier, and the HHA would be expected to document the refusal and
communicate with the patient and representative/care giver to help meet
their healthcare needs to the best of the HHA's ability.
Comment: A commenter disagreed with the proposed regulation that an
HHA would be permitted to discharge a patient when the patient or payer
will no longer pay for the services provided by the HHA. The commenter
stated that this regulation would conflict with the regulation in one
state. Another commenter suggested that the regulation should be
clarified with regard to what it means for a patient to no longer pay
for services. Specifically, the commenter stated that discharge for
non-payment should not be allowed in situations when a patient has
submitted to a third party payer the paperwork necessary for the bill
to be paid, and the bill is still pending.
Response: For those instances where state and federal laws overlap,
the stricter regulation would prevail. For example, if a state
regulation did not allow HHAs to discharge a patient due to a lack of
payment, then the HHA would have to comply with state law, since state
law prohibits discharge while federal regulations permit it. We agree
that a discharge for non-payment is not to be considered until all
payment source options have been fully explored and payment from a
third party is no longer considered pending.
Comment: Some commenters opposed the proposal that an HHA be
permitted to discharge a patient when the physician and HHA agreed that
the patient no longer needed HHA services because the patient's health
and safety had improved or stabilized sufficiently. The commenters
stated that this regulation would, in certain cases, violate Medicare
coverage law and regulations, as well as the settlement agreement in
Jimmo v. Sebelius (see Jimmo et al. v. Sebelius, D.Vt, No. 11-cv-17,
October 25, 2011, 2011 WL 5104355).
Response: The proposed rule stated that discharge or transfer would
be permitted if it is appropriate because the patient's health and
safety have improved or stabilized sufficiently, and the HHA and the
physician who is responsible for the home health plan of care agree
that the patient no longer needs the HHA's services. Our intent was
that, if the physician responsible for issuing orders related to the
reason that HHA care was initiated and the HHA both agree that a
patient has achieved the goals set forth in the plan of care (see Sec.
484.60(a)(2)(xiv)), then discharge would be appropriate because the
goals of care have been achieved. We have clarified this original
intent in the regulation to assure that it is appropriately
implemented. If the patient disagrees with a discharge or transfer, he
or she has the right to appeal the decision. As set forth in Sec.
484.50(c)(8), each patient has the right to receive proper written
notice, in advance of a specific service being furnished, if the HHA
believes that the service may be non-covered care; or in advance of the
HHA reducing or terminating on-going care. The HHA must also comply
with the requirements of 42 CFR 405.1200 through 405.1204. This written
notice includes information related to patient appeals. Finally, the
Jimmo settlement agreement pertains only to guidance, not to
regulations, and does not prevent implementation of new regulations.
Comment: A few commenters submitted suggestions to clarify the
proposed discharge requirements for situations when patients refuse HHA
services. One commenter noted that there are various degrees of which a
patient may refuse services. For example, a patient may refuse an IV
antibiotic, but accept therapy services in lieu of such treatment. The
commenter suggested that only a refusal of all HHA services would
warrant discharge. Other commenters suggested that it is not the
refusal of services in and of itself that would necessitate a
discharge. Rather, it is the effect of that refusal that may make
discharge appropriate. These commenters stated that HHAs should be
allowed to discharge or transfer a patient at any time when the refusal
of services or the refusal to follow the agreed upon plan of care
results in the HHA being unable to effectively deliver care.
Response: As stated previously, patients have the right to decline
services. If a patient declines something minor, such as declining a
bath due to fatigue that day, we would expect the HHA to document this
in the clinical record. If the patient or patient representative
declines large aspects of care (such as dressing changes or essential
medications) then the HHA has the responsibility to document this in
the clinical record and communicate with the patient regarding
implications of the decline. We would expect HHAs to explore
alternative options for providing care that is both consistent with
patient preferences that continues to meet the patient specific needs
as identified in the comprehensive assessment, and the measurable
outcomes and goals identified by the HHA and the patient. The HHA would
also need to communicate with the physician regarding the decline of
services that have the potential to compromise the HHA's ability to
safely and effectively deliver care to the extent that that the HHA can
no longer meet the patient's needs, and discuss the options. The HHA
may consider discharge if the patient's decline of services compromises
the HHA's ability to safely and effectively deliver care to the extent
that that the HHA can no longer meet the patient's needs. We would
expect HHAs to advise the patient, the representative (if any), the
physician(s) issuing orders for the home health plan of care, and the
patient's follow-up care professional (if any) that a discharge is
being considered because the HHA can no longer meet the patient's
needs. HHAs should also provide the patient and representative (if any)
with contact information for other agencies or providers who may be
able to provide care following discharge from the HHA.

[[Page 4528]]

Comment: Many commenters stated that HHAs should be explicitly
permitted to discharge a patient for cause if the safety of the HHA's
staff is threatened. In such situations, commenters suggested that
reporting the danger to the proper authorities, such as law
enforcement, protective services, etc., should suffice for
documentation of the significant safety hazard that warranted a
discharge. Other commenters suggested a broader list of reasons related
to staff well-being that they believed would warrant discharging a
patient from services, such as sexual harassment or verbal abuse. A
commenter also suggested that, if a patient is discharged for reasons
related to HHA staff safety and well-being, the HHA should be permitted
to conduct the discharge process via alternative means, such as by
phone, mail or electronic communication.
Response: The proposed regulation text states that if ``the
patient's (or other persons in the patient's home) behavior is
disruptive, abusive, or uncooperative to the extent that delivery of
care to the patient or the ability of the HHA to operate effectively is
seriously impaired,'' then the HHA may discharge the patient after
following certain intermediary steps to attempt to resolve the
issue(s). We believe this requirement already includes situations where
the HHA's staff feels threatened, as such situations would seriously
impair the HHA's ability to operate effectively in the delivery of
care. We also believe the proposed requirement for documenting the
problem and efforts made to resolve the problem will be sufficient for
documentation purposes. If HHA staff felt that re-entry to the
patient's residence was unsafe for them, the discharge process could be
handled by way of an alternative method (for example, phone or
electronic mail) rather than face-to-face communication.
Comment: While many commenters suggested that HHAs should be
permitted to discharge patients for cause at the discretion of the HHA,
without any regulatory limitations, other commenters strongly opposed
the concept of discharge for cause in its entirety, suggesting that a
discharge for cause provision would be used to ``dump'' patients (or
patients who have caregivers) who they could claim were being
``difficult.''
Response: While we acknowledge that the discharge for cause
provision may be subject to misuse in rare cases, we do not believe
that the potential for abuse is appropriately counteracted by the
complete removal of all discharge for cause options. Likewise, while we
acknowledge that the discharge for cause provisions impose significant
limits upon an HHA's ability to discharge patients who may be perceived
as being ``difficult,'' we believe that these restrictions are
essential in order to minimize the potential for inappropriate
discharges. As part of the survey monitoring process, HHA's may be
asked if there have been patients who have been discharged for cause.
The surveyor may also request the patient(s) record as part of the
clinical record review process during the survey. We believe that this
type of monitoring may mitigate potential negative behaviors in an HHA.
Comment: A commenter opposed a statement in the preamble of the
proposed rule that ``it would be incumbent upon the HHA to take all
reasonable steps to resolve safety and noncompliance issues prior to
taking steps to discharge a patient.'' The commenter stated that the
word ``all'' is overly broad and implies that corrective action is
entirely up to the agency.
Response: It appears that the intent of the statement was
misunderstood. Rather that requiring that ``all'' steps be taken, this
statement was intended to convey the message that ``all reasonable''
steps must be taken prior to discharging a patient for cause. HHAs
would be expected to take every reasonable step that is available to
them in order to resolve the issue(s) at hand prior to initiating a
discharge for cause.
Comment: A few commenters requested clarification regarding the
proposed requirement that HHAs investigate injuries of unknown source.
Commenters sought guidance on how and to what extent HHAs should
conduct such investigations. The commenters noted that patients are in
the presence of HHA personnel for a very limited amount of time, and
that HHAs should not be held responsible for minor injuries that occur
in the course of everyday life, such as bruises and cuts.
Response: We appreciate the commenters' views and the opportunity
to clarify the parameters an HHA should use when investigating an
injury of an unknown source. An injury should be classified as an
``injury of unknown source'' when both of the following conditions are
met: (1) The source of the injury was not observed by any person or the
source of the injury could not be explained by the patient; and (2) The
injury is suspicious because of the extent of the injury, or the
location of the injury (for example, the injury is located in an area
not generally vulnerable to trauma), or the number of injuries observed
at one particular point in time, or the recurring incidence of injuries
over time. The type, extent, process, and personnel involved for
investigations would be left to the discretion of the HHA. HHAs are
responsible for asking the questions necessary to determine whether
minor injuries are indicative of more significant concerns.
Furthermore, HHAs are responsible for complying with applicable state-
specific reporting laws, in accordance with the requirements of Sec.
484.50(e)(2).
Comment: While several commenters expressed strong support for the
proposed requirement to investigate patient complaints regarding
potential violations of patient rights, several other commenters
offered suggested revisions to this requirement. While one commenter
stated that CMS should recognize that investigations necessarily must
vary in terms of intensity and duration, depending on the complaint
alleged, and as such, any required investigation process should be
flexible enough to allow for calibration to the circumstances, other
commenters disagreed with the open-ended manner in which the standard
was written, calling it ``too vague.'' Some commenters sought specific
parameters for what constitutes appropriate reporting and
documentation. Others suggested that the regulation should include
examples of authorities to whom patient rights violations should be
reported, such as adult protective services, law enforcement, and the
state licensure agency. Additionally, others suggested that the
regulation should identify and delineate complaints into different
categories by level of severity, and implement a clear process for
investigation for each different level. Still another commenter
suggested that we should create a robust and detailed complaint
investigation standard that requires the following:
HHAs must have a complaint process, complete with policies
and procedures, that is provided, in writing, to the patient, the
patient's representative, and the patient's caregivers at the time of
admission and each time the plan of care is updated.
HHAs must provide a written report to the patient,
documenting the findings of the investigation and resolution of the
complaint within 14 calendar days of its receipt.
If the patient is not satisfied with the HHA's response,
the patient should be permitted to request another review, and the HHA
would be responsible for responding, in writing, within 30 days from
the date it received the patient's request for review.
The HHA's response to this second review would be required
to include the

[[Page 4529]]

telephone number and address of all agencies and programs with which a
complaint may be filed, and the telephone number of the state home
health hotline.
Response: We believe the proposed general language establishing an
expectation for patient complaint investigation and reporting, without
specifying details, is the most appropriate regulatory approach given
the wide variety of situations that HHAs will likely encounter. We
agree that HHAs will experience varying levels of intensity and
duration when investigating patient complaints. These investigation and
reporting suggestions from the commenters are all appropriate elements
for HHAs to include in their internal policies and procedures for
implementing this general requirement.
Comment: A few commenters sought clarification on the relationship
between the proposed patient rights violation reporting requirements
and existing state laws and regulations. One commenter stated that its
state law requires HHAs, rather than HHA staff, to report
misappropriation of patient property. Another commenter suggested that
the reporting requirement should be qualified by the phrase ``in
accordance with state law'' to assure that reporting meets current
state requirements. A commenter also suggested that any HHA staff
member who identifies, notices, or recognizes incidences or
circumstances of mistreatment, neglect, verbal, mental, sexual, and/or
physical abuse, including injuries of unknown source, or
misappropriation of patient property, should be required to report said
incidences or circumstances directly to law enforcement, in addition to
reporting to the HHA management.
Response: We agree with the commenter that reporting should occur
in accordance with state law, and have amended the regulations at Sec.
484.50(e) to include this requirement. We note that, where these
federal requirements are more stringent, HHAs are expected to comply
with the more stringent federal requirement. We believe allowing each
HHA to establish its own policies and precise chain of command for
reporting incidents will give them the flexibility to meet the various
levels of incidents and behavior, and to respond appropriately.
Comment: A commenter suggested that the regulation should state
that a patient complaint may not be investigated by any HHA staff
involved in the complaint.
Response: We agree that this is the appropriate policy for all
HHAs, and would expect HHAs to exercise appropriate discretion in their
investigations. However, we do not believe that this needs to be
incorporated into the regulatory text, which establishes the broad
goals for investigations rather than the specific mechanisms for them.
Comment: A commenter suggested that the regulation should clarify
that complaints by a patient, representative, or caregiver may include,
but are not limited to, complaints regarding treatment or care that is
(or fails to be) furnished, is furnished inconsistently, or is
furnished inappropriately. Another commenter suggested that the
regulation should state that the patient has the right to make
complaints ``without discrimination, retaliation or fear of retaliation
to the HHA and the state survey and certification agency.''
Response: We agree that the topics set forth in the proposed rule
are not the only issues that a patient may make complaints about, and
have revised regulatory text at Sec. 484.50(e) accordingly. We also
agree that patients have the right to exercise their right to complain
without discrimination, retaliation or fear of retaliation. This
concept is reflected in Sec. 484.50(c)(11), which states that the
patient has the right to be free from any discrimination or reprisal
for exercising his or her rights or for voicing grievances to the HHA
or an outside entity. This would include the right set forth in Sec.
484.50(c)(3) to ``Make complaints to the HHA regarding treatment or
care that is (or fails to be) furnished, and the lack of respect for
property and/or person by anyone who is furnishing services on behalf
of the HHA.''
Comment: A commenter suggested that the regulation should
specifically state that an HHA must take action to prevent further
potential violations, including retaliation, while the complaint is
being investigated.
Response: We agree that HHAs should take all appropriate steps to
prevent retaliation, and have incorporated this requirement into the
regulatory text at Sec. 484.50(e)(1)(iii).
Comment: A few commenters expressed concern regarding the proposed
requirement to provide auxiliary aids to patients for the purpose of
facilitating communication, citing the potentially large expense of
certain auxiliary aids. Commenters stated that HHAs should be expected
to make efforts to facilitate acquisition of auxiliary aids for
patients, but not be required to provide more expensive equipment
directly. Commenters also sought clarification of the proposed
requirement to provide patient rights information in alternate formats.
Specifically, the commenters stated that the term ``alternate formats''
is unclear.
Response: The provisions of the Americans with Disabilities Act and
Section 504 of the Rehabilitation Act require facilities to provide
equal access to individuals with disabilities. If the provision of
auxiliary aids becomes an ``undue burden,'' the HHA may seek protection
that is available under section 504 of the Rehabilitation Act. As we
noted in the preamble of the proposed regulation, the alternate formats
expectation includes, but is not limited to, the provision of qualified
interpreters, large print documents, Braille, digital versions of
documents, and audio recording.
Comment: Several commenters made suggestions regarding ways that
CMS and HHAs could address the issue of health disparities. Comments
ranged from providing a standardized notice of patient rights in
multiple languages to requiring HHAs to employ personnel who are
similar in age, gender, and background to the HHA's patient population
to formulating a CMS-wide response to the results of the vulnerable
care study mandated by the Affordable Care Act.
Response: We appreciate these suggestions that commenters
submitted; however, they are beyond the scope of this rule. We will
retain these suggestions for future consideration.
Comprehensive Assessment of Patients
Comment: A commenter stated that the requirement for each patient
to have an initial and comprehensive assessment should only apply to
those patients who are receiving skilled care. Another commenter asked
whether the proposed content elements of the comprehensive assessment
applied to patients from all payer sources, or only to a subset of
patients with certain specified payer sources, such as Medicare and
Medicaid.
Response: We do not believe that limiting the assessment
requirements solely to those patients set to receive skilled care
services or to those patients who have Medicare or Medicaid as a
payment source would be in the best interest of patients. The patient
assessment is designed to identify patient needs, and all patients will
have needs to be assessed. Therefore we are maintaining the requirement
that all patients must be assessed; otherwise they would not be
receiving HHA services in the first place.
Comment: The majority of commenters who submitted comments on this
section made suggestions regarding the professionals who are permitted
to complete the initial and

[[Page 4530]]

comprehensive patient assessments under various circumstances.
Suggestions included allowing a therapy discipline to complete the
assessments as long as that therapy is ordered, and allowing therapists
to complete all assessments in all situations to allowing occupational
therapists to complete the assessments in therapy-only, but not
necessarily occupational therapy-only, situations.
Response: The suggestions made by commenters go far beyond our
original intent to maintain the long-standing requirements that was
proposed in the October 2014 rule. Since this would be a significant
change to what was originally proposed, we believe that the most
appropriate course of action would be to address this issue in separate
notice and comment rulemaking at a future date. Therefore, we are
finalizing the proposed requirements, which is a continuation of
longstanding CMS policy.
Comment: A commenter stated that the 5 day time frame within which
HHAs must complete the comprehensive assessment may not be sufficient
to capture the full extent of some of these proposed factors in the
comprehensive assessment, such as psychosocial and cognitive status,
for certain patients. The commenter stated that this is due, in part,
to the nature of certain conditions--especially psychosocial
conditions--and, in part, to the focus on stabilization that consumes
much of the initial visit(s). The commenter recommended that CMS should
acknowledge this limitation, and should provide for additional time to
complete the comprehensive assessment in limited, necessary
circumstances.
Response: We do not agree that a period of greater than 5 days is
necessary to gather information regarding all elements of the patient
assessment. HHAs are already accustomed to completing the current
assessment requirements within 5 days, and there is no evidence that
patient care has suffered because of the failure of additional
conditions to manifest themselves within that timeframe. While we
acknowledge that this rule will expand the content of the assessment,
such expansion is in keeping with current best practices and can be
incorporated into HHA assessment timelines without undue burden. We
note that hospice care providers, who operate under similar conditions,
and who are also required to complete a patient assessment of very
similar content, have developed ways to successfully assess things such
as psychosocial condition within the same 5 day period as we are
finalizing in this rule. Given the success of another very similar
provider type in meeting this timeline, we believe that it is
appropriate to maintain the 5 day timeline for HHAs. The 5 day timeline
to complete the comprehensive assessment begins upon the physician
ordered start of care date. If an HHA is unable to begin care on that
date for any reason, we would expect the HHA to decline the referral
because it is unable to meet the patient's needs in a timely manner. It
is not acceptable for an HHA to seek a new referral with a new start of
care date that is more convenient for the HHA.
Comment: Several commenters expressed support for the proposed
requirement that, when occupational therapy is the only service ordered
by the physician who is responsible for the home health plan of care,
and if the need for that service establishes program eligibility, the
initial assessment visit may be made by the occupational therapist. The
commenters interpreted this requirement to mean that occupational
therapy in now permitted to establish eligibility for the Medicare home
health benefit.
Response: We appreciate the commenters' support. However, we did
not propose to change the requirements for establishing eligibility for
the Medicare home health benefit. Rather, we proposed that if
occupational therapy established eligibility, which may occur for a
non-Medicare home health benefit such as private insurance or for a
subsequent episode of home health care when the continuing need for
occupational therapy establishes Medicare eligibility for the home
health benefit, then the occupational therapist may perform the
assessment.
Comment: A commenter noted that the new requirements related to the
content of the comprehensive assessment will require revisions to forms
and electronic medical records in order to assure that all information
is documented appropriately.
Response: Neither the proposed rule nor the final rule mandate the
use of a specific assessment form or electronic medical records (EMRs),
which may also be referred to as electronic health records (EHRs). The
extent to which HHAs choose to revise their forms or EMRs is entirely
left to their discretion.
Comment: A commenter suggested that information about caregivers
should be gathered as part of the comprehensive assessment. The
commenter noted that oftentimes caregivers play a significant role in
care delivery, as indicated by the proposed rule's inclusion of
specific requirements related to caregiver education and training.
Given their important role in care delivery, the commenter suggested
that the patient assessment should include the following additional
elements: caregiver willingness and ability to provide care; caregiver
availability and schedules (for example, hours worked outside the
home); the caregiver's current level of comfort in carrying out
medical/nursing tasks or assisting with activities of daily living; and
a brief screen for caregiver strain or depression. The commenter
suggested that these elements are necessary in developing an
understanding of a caregiver's particular situation in order to best
provide appropriate and effective caregiver education and training.
Response: We agree that gathering certain key information about
caregivers is essential for effective HHA care planning activities.
HHAs cannot develop a schedule for turning a bed-bound patient, for
example, without knowing the times when a caregiver would be available
to perform the task. Thus, we are adding a requirement in this final
rule that, as part of assessing patient caregivers (proposed and
finalized at Sec. 484.55(c)(6)), HHAs will be required to gather
information regarding caregiver willingness, ability, availability, and
schedules. We believe that the concept of ``willingness and ability''
adequately covers a caregiver's level of comfort in carrying out tasks.
We believe that these concepts fit well with the finalized requirement
at Sec. 484.60(d)(5) that an HHA must ensure that each patient, and
his or her caregiver(s), receive ongoing education and training
provided by the HHA, as appropriate, regarding the care and services
identified in the plan of care. However, screening for caregiver
strain/depression is beyond the scope of HHA services as set forth in
the Act. While these screenings are certainly a best practice that we
encourage HHAs to incorporate on their own, we do not have the
authority to expand the unit of care beyond the patient.
Comment: A commenter recommended that the comprehensive assessment
regulation should address the use of standardized tests and measures by
home health clinicians. The commenter stated that the use of
standardized tests and measures early in an episode of care establishes
the baseline status of the patient, assists in the development of the
plan of care, and provides a means to quantify change in the patient's
functioning. Outcome measures, along with other standardized tests and
measures used throughout the episode of care, as part of periodic
reexamination, provide information

[[Page 4531]]

about whether predicted outcomes are being realized.
Response: We fully support the use of standardized data elements,
tools, and measures by HHAs. To that end, the OASIS already provides
standardized data elements that HHAs may use to establish the baseline
status of the patient, assist in the development of the plan of care,
and provide a means to quantify change in the patient's functioning.
For those aspects of the patient assessment that are not captured via
OASIS data elements, we encourage HHAs to use standardized data
elements, tools, and measures that are available from national sources.
This may include measurement scales such as the Functional Independence
Measure and Functional Assessment Measure (http://www.dementia-assessment.com.au/symptoms/fim_manual.pdf) and the Chedoke-McMaster
Stroke Assessment (http://www.rehabmeasures.org/pdf%20library/cmsa%20manual%20and%20score%20form.pdf) to name a few.
Comment: While most commenters expressed general support for our
proposal to expand the required elements of the comprehensive
assessment, several commenters requested additional clarification
regarding specific proposed elements of the comprehensive assessment as
follows: Psychosocial status, and cognitive status. Specifically,
commenters sought more information regarding the extent to which these
proposed elements may or may not differ from similar OASIS items
(M1700-M1750), the meaning and intent of the term ``psychosocial,'' and
the goals that CMS wants to achieve as a result of requiring an HHA to
assess psychosocial and cognitive status.
Response: We appreciate the opportunity to clarify the intent of
these requirements. Assessing a patient's psychosocial status refers to
an evaluation of his or her mental health, social status, and
functional capacity within the community by looking at issues
surrounding both a patient's psychological and social condition (for
example, education and marital history). This provision is intended to
be a screening for potential issues that may complicate or interfere
with the delivery of HHA services and the patient's ability to
participate in his or her own care. Based on the results of this
screening, an HHA may need to make referrals to additional care sources
and other outside entities. Assessing a patient's ``cognitive status''
refers to an evaluation of the degree of his or her ability to
understand, remember, and participate in developing and implementing
the plan of care. Numerous screening tools are available that HHAs may
choose to use in order to implement this requirement (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2117747/). We are not requiring
the use of any particular tool, nor are we prescribing the extent of
the cognitive status assessment. Our goal is to make cognitive
assessment a routine practice in HHAs so that HHAs can use this
information in developing and implementing the patient-specific plan of
care, and so that HHAs identify potentially unmet patient needs that
warrant follow-up care with another health care provider, with the HHA
making appropriate referrals as needed. We agree that there is
crossover between these assessment elements and those items already
included in the OASIS. However, those items included in the OASIS may
not be sufficient for all patients. That is to say, some patients may
require additional assessment beyond what is required in the OASIS, and
we expect HHAs to revise or expand their patient assessment, as needed,
to assure that each patient's psychosocial and cognitive status are
assessed. The goal of this requirement is to enable HHAs to develop a
more complete and person-centered understanding of the patient.
Comment: A commenter requested additional information regarding the
intent and meaning of the proposed requirement that an HHA would
identify a patient's strengths and care preferences. Another commenter
requested guidance on honoring patient care preferences in case-by-case
situations, such as when a patient prefers a shower bath on a day that
they are feeling well versus the bed bath that is scheduled for that
day.
Response: Traditionally the home health plan of care has been
developed with a focus on patient deficits that require treatment. The
physician and the HHA decide how to treat these deficits, and patients
are told what is going to be done. This model of care places patients
in a passive recipient role that does not optimize the achievement of
positive patient outcomes. First, this model does not take into account
those patient-strengths that can be harnessed by the HHA staff and plan
of care to facilitate patient well-being. Examples of patient strengths
that HHAs may identify, through observation and directly asking the
patient to identify his or her own strengths, may include things such
as knowledge of medications, motivation and readiness for change,
vocational interests/hobbies, interpersonal relationships and supports,
and financial stability. HHAs need to look at a patient's deficits as
well as their strengths in order to develop a complete understanding of
the patient, and we believe that this requirement will facilitate this
practice.
Second, the traditional model of home care tells patients what is
going to be done rather than asking patients what their care
preferences are. The requirement to gather information regarding
patient care preferences and take them into account when developing and
implementing the home health plan of care seeks to revise this
approach. We would expect patients to be engaged as active participants
in their own care, and this begins with gathering and taking into
account patient preferences regarding their care. For example, if a
patient prefers a shower on a day when a bed bath is scheduled, or,
conversely, if a patient prefers a bed bath on a day when a shower is
scheduled, we would expect the HHA to take this preference into account
and accommodate it to the greatest degree possible. Patient care
preferences may go beyond basic daily decisions. Some patients may
prefer to have a greater degree of pain control requiring medications
that impair the ability to safely function independently while other
patients may prefer to take less medication, even if that means a
higher level of pain, to allow a greater degree of independence to
safely function. Each patient has their own set of care preferences,
and we would require HHAs to both identify and respect these care
preferences to the greatest degree possible. Our goal is to assure that
HHAs plan for and provide care that is both patient-directed and in
accordance with the physician-ordered plan of care.
Comment: A few commenters requested clarification regarding
proposed Sec. 484.55(c)(8), which would require the comprehensive
assessment to include data items collected at inpatient facility
admission or discharge only. The commenters wanted to know what data
items were being referred to in this requirement. The commenters asked
if this requirement was in reference to the inpatient facility
discharge/home health agency referral paperwork, or if there were other
data items that we had in mind when developing this proposed
requirement.
Response: The phrase ``data items collected at inpatient facility
admission or discharge only'' is included in the regulations that HHAs
have been required to comply with for more than a decade. This phrase
refers to specific OASIS data elements (see https://www.cms.gov/
Medicare/Quality-

[[Page 4532]]

Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/
OASIS-C1-DataSets.html). Specifically, in OASIS-C1/ICD 10, ``data items
collected at inpatient facility admission'' is equivalent to those
items that must be collected for ``Transfer to an Inpatient Facility.''
The data items collected at ``discharge only'' are equivalent to those
items that must be collected for ``Discharge from Agency--Not to an
Inpatient Facility Death at home,'' and ``Discharge from agency.'' No
change to these data set items is being made at this time.
Comment: A commenter requested clarification on the criteria HHAs
should use to determine when a change in a patient's condition warrants
an update to the comprehensive assessment. The commenter interpreted
this requirement to mean that an update to the comprehensive assessment
is required only in situations where the change in a patient's
condition is significant enough that it warrants close monitoring by
HHA staff or results in a revision to the plan of care.
Response: The proposed provisions do not reflect a change in our
policy. Current policy requires each HHA to have a policy defining a
significant change in condition that would trigger an update to the
assessment. For example, an initiation or discontinuation of a service,
or a significant improvement or worsening of a patient's condition not
anticipated in the plan of care. It will be up to each individual HHA
to determine how a significant change in condition is to be defined.
Comment: All commenters who submitted comments regarding the
proposed allowance for a physician-ordered resumption of care date
fully supported this proposed change. One commenter suggested that the
requirement to update the comprehensive assessment within 48 hours of
the patient's return to the home from a hospital admission should be
reconsidered because a hospital stay is not the only marker of a change
in condition that would warrant an update to the comprehensive
assessment. The commenter noted that patients with extended emergency
room stays, patients who are in the hospital on observation status, and
patients who are accessing urgent care may all be appropriate
candidates for a physician-ordered re-assessment.
Response: We agree that extended patients who experience extended
emergency room stays, being kept in the hospital on observation status,
and utilizing urgent care services for urgent concerns may be in need
of an update to the comprehensive assessment. These situations are all
examples of a ``significant change in condition.'' The regulation at
Sec. 484.55(d) requires that the comprehensive assessment must be
updated and revised (including the administration of the OASIS) as
frequently as the patient's condition warrants due to a major decline
or improvement in the patient's health status, but not less frequently
than the last 5 days of every 60 days beginning with the start-of-care
date, unless there is a significant change in condition. Consistent
with current CMS policy, HHAs are expected to develop policies and
procedures that establish the parameters for what constitutes a
``significant change in condition.'' We believe that extended emergency
room stays, patients who are in the hospital on observation status, and
patients who are accessing urgent care are all experiencing a
``significant change in condition'' that would warrant a patient
assessment. Therefore, we do not believe that it is necessary to
explicitly incorporate these circumstances into the regulation because
they are already captured under the broader heading of ``significant
change in condition.''
Care Planning, Coordination of Services, and Quality of Care
Comment: A commenter suggested that the requirement to develop an
individualized plan of care should only apply to patients receiving
skilled services. In other words, the plan of care requirements should
not apply to those patients that only receive non-skilled (that is,
homemaker) services.
Response: All patient care, regardless of the level of clinical
skill involved, should be delivered in accordance with a plan of care.
To do otherwise would create opportunities for uncoordinated care,
duplication of services, and missing services.
Comment: A commenter stated that the use of the terms ``plan of
care'' and ``care plan'' throughout the rule is confusing because some
may interpret these two terms as being two separate documents. The
commenter suggested that a single term be used consistently in order to
avoid potential confusion.
Response: The use of ``care plan'' and ``plan of care'' were
intended to mean the same thing. However, in order to avoid the
potential for any confusion, we are using the term ``plan of care''
throughout to express this concept.
Comment: Most commenters expressed strong support for the overall
concept of an HHA developing a patient-specific, patient-centered plan
of care for each patient. The commenters stated that the revised
requirement would better ensure that the patient will, indeed, receive
all the services and education called for in the plan of care. One
commenter suggested that the requirement should specify that each plan
of care be individualized to the patient's needs, as reflected in the
comprehensive assessment.
Response: We agree that the plan of care should be based on the
assessment and that it is important for the plan to specify patient
education and training. We understand that is standard of practice for
the patient to receive written care information based off the
individualize plan of care, from the HHA outlining the medication
schedule/instructions, visit schedule and any other pertinent
instruction related to the patients care and treatments that the HHA
will provide. We believe that this is critical information to improve
the patient and caregiver comprehension of diagnosis and treatment,
improve compliance with medications and treatment schedules and promote
high quality care for the patient. Therefore, in response to comments,
we have revised our proposed rule to create a new standard at Sec.
484.60(e), ``Written information to the patient.'' The new provision
requires the HHA to provide written instructions to the patient and
care giver outlining visit schedule, including frequency of visits;
medication schedule/instructions; treatments administered by HHA
personnel and personnel acting on the behalf of the HHA; pertinent
instructions related to patient care; and the name and contact
information of the HHA clinical manager.
Comment: A commenter requested examples of effective
interdisciplinary teams.
Response: Interdisciplinary teams work together, each member
contributing their knowledge and skills, interacting with and building
upon each other, to enhance patient care. The interdisciplinary team
model is the foundation of care in other health care providers, such as
hospices and complex chronic care management practices. HHAs may choose
to develop interdisciplinary team models based on the experiences and
knowledge developed by these similar care providers, or may develop
their own strategies and structures to create effective
interdisciplinary teams.
Comment: A commenter requested clarification of the term ``social
needs'' in the context of the proposed requirement that patients are
accepted for treatment on the reasonable expectation that an HHA can
meet the patient's medical, nursing,

[[Page 4533]]

rehabilitative, and social needs in his or her place of residence.
Response: Patients come from a variety of backgrounds and settings,
each with their own social needs. Some patients require a more intense
level of services based on their social needs, and not all HHAs have
the staff (for example, social workers) or other capabilities to meet
the needs of all patients. Patient social needs may include
intrapersonal and interpersonal relationships in the immediate family,
financial status, homemaker/household needs, vocational rehabilitation
needs, family social problems, transportation needs, and recreational
needs. This requirement assures that, if a patient has social needs
that go beyond the capabilities of the HHA and/or they would interfere
with the HHA's ability to safely and effectively deliver patient care,
the HHA would not be expected to accept that patient for care.
Comment: A few commenters suggested that licensed practitioners,
such as nurse practitioners and physician assistants, should be
permitted to review, sign and order home health services for patients
served by Medicare certified HHAs. Other commenters suggested that
``physician extenders'' should be authorized to provide verbal orders.
The commenter stated that, as necessary, their orders could be co-
signed by the physicians to whom they report for the purposes of
billing.
Response: Section 1861(m) of the Act requires that the home health
plan of care be established and maintained by a physician. Section
1861(r) of the Act defines ``physician'' in a manner that does not
include other licensed practitioners, such as nurse practitioners and
physician assistants. Therefore, pursuant to statute, other licensed
practitioners may not establish and maintain the home health plan of
care, including reviewing, signing, and ordering home health services.
Comment: A commenter suggested that the individualized plan of care
should be required to identify caregiver needs.
Response: While the needs of caregivers are important, they are
beyond the scope of the home health benefit as set forth in the Social
Security Act. It would be inappropriate to require HHAs to identify
caregiver needs in the home health plan of care, as HHAs would then be
obligated to deliver care to meet those needs and such an obligation is
beyond the scope of covered HHA services.
Comment: A commenter stated that the regulation should include more
specificity regarding the proposed requirement that the plan of care
would include safety requirements, functional limitations and
nutritional requirements. The commenter stated that the regulation
should specify the data elements and level of detail for these aspects
of the plan of care because there are no industry standards for them.
Response: The intent of this final rule is to allow HHAs
flexibility, where appropriate, to tailor their practices to the needs
and preferences of their patients and staff, to the extent possible.
Thus, specifying the data elements and exact level of detail for these
aspects of the plan of care would not be in keeping with the intent of
this rule. HHAs may identify data elements at a level of detail that
meets the needs of patients and clinicians.
Comment: A small number of commenters requested clarification of
the proposed requirement that each patient's plan of care be required
to include the frequency and duration of visits to be made. One
commenter stated that HHAs currently indicate visit frequency and
duration in their plans of care, and questioned whether the proposed
requirement is different from this current practice. Another commenter
stated that some HHAs prescribe visit frequencies that span the entire
60 day certification period, while other HHAs prescribe visit
frequencies and durations based on the patient's condition and best
practices. The commenter wanted to know if the proposal would require
HHAs to assure that visit frequencies and durations are based on
assessment and plan of care findings, rather than on general episodes
of care.
Response: The term ``frequency'' is used to refer to the frequency
of services that are ordered by the physician (for example, nursing 2
to 4 times per week). Likewise, the term ``duration'' refers to the
amount of time for a given frequency (for example, 5 weeks of nursing
services, with nursing 2 to 4 times per week for the first 3 weeks, and
1 to 3 times per week for the last 2 weeks) and may, in the case of
therapy services, also refer to visit lengths and/or intervention
lengths (for example, 90 minute visit, 70 minutes therapeutic
interventions and 20 minutes heat application). We expect the plan of
care to contain visit frequencies and durations based on the patient-
specific needs as assessed in the patient assessment. This may or may
not mean that visit frequencies and durations will account for the
entire 60 day certification period.
Comment: A small number of commenters suggested that HHAs should
not be required to include a patient's rehabilitation potential in the
plan of care because some patients receive home health services for
skilled maintenance therapy and, therefore, this element may be
unnecessary. Commenters also expressed concern regarding the presence
of this element in the plan of care in relationship to the medical
review process that is related to HHA payment policy. These commenters
believe that including information related to rehabilitation potential
in the plan of care may create problems for HHAs during medical review.
Response: We believe that including ``rehabilitation potential'' on
the plan of care is appropriate for all patients, including those
patients receiving skilled maintenance therapy. Assuming all other
eligibility and coverage requirements are met, skilled maintenance
therapy services are covered when an individualized assessment of the
patient's clinical condition demonstrates that the specialized
judgment, knowledge, and skills of a qualified therapist are necessary
for the performance of a safe and effective maintenance program.
``Rehabilitation potential'' in the plan of care should include
expected outcomes and the plan of care must also list measureable
goals. The ``rehabilitation potential'' or the expected outcome of
maintenance therapy can be to preserve and maintain the patient's
current condition or to prevent or slow further deterioration. In
addition, the home health record must specify the purpose of the
skilled service required.
We remind the commenters that HHAs are required to report all
services provided to the beneficiary during each episode, this includes
reporting each visit in line-item detail. Therefore, it is expected
that the home health records for every visit will reflect the need for
the skilled care provided. In accordance with Chapter 7 of the Medicare
Benefit Policy Manual (Pub. 100-02, section 40.2.1, https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c07.pdf) these clinical notes are also expected to provide
important communication among all members of the home care team
regarding the development, course and outcomes of the skilled
observations, assessments, treatment and training performed. Taken as a
whole then, the clinical notes are expected to tell the story of the
patient's achievement towards his or her goals as outlined in the plan
of care. In this way, the notes will serve to demonstrate why a skilled
service is needed. Therefore, in accordance with Chapter 7 of the
Medicare Benefit Policy Manual, the

[[Page 4534]]

home health clinical notes must document as appropriate:
The history and physical exam pertinent to the day's
visit, (including the response or changes in behavior to previously
administered skilled services) and
The skilled services applied on the current visit, and
The patient/caregiver's immediate response to the skilled
services provided, and
The plan for the next visit based on the rationale of
prior results.
Clinical notes should be written such that they adequately describe
the reaction of a patient to his or her skilled care. Clinical notes
should also provide a clear picture of the treatment, as well as ``next
steps'' to be taken. When the skilled service is being provided to
either maintain the patient's condition or prevent or slow further
deterioration, Chapter 7 of the Medicare Benefit Policy Manual requires
that the clinical notes must also:
Include a detailed rationale that explains the need for
the skilled service in light of the patient's overall medical condition
and experiences,
Describe the complexity of the service to be performed,
and
Describe any other pertinent characteristics of the
beneficiary or home.
Finally, CMS requires the therapist to initially assess (and
reassess at least every 30 calendar days) the patient using a method
which allows for objective measurement of function and successive
comparison of measurements. The therapist must document the measurement
results in the clinical record.
Comment: All commenters who commented on the proposed requirement
that each patient's plan of care must include patient and caregiver
education and training to facilitate timely discharge expressed full
support for this proposal. One commenter highlighted resources for
caregiver education and training that are available from the
Alzheimer's Association. The Association provides a wide variety of
caregiver resources, which can be found at www.alz.org, as well as
through a 24/7 Helpline at 800-272-3900. A commenter also highlighted
the Chronic Disease Self-Management Program (CDSMP) based at Stanford
University's School of Medicine and the Skills2Care program, which
helps caregivers to manage the challenges of dementia in the home.
Response: We appreciate the support from commenters, and agree that
the resources noted in comments may be helpful to HHAs.
Comment: A single commenter requested guidance for handling
situations in which it has been determined by clinical assessment that
a patient is able to learn how to self[hyphen]administer insulin but
simply refuses to learn, and there is no able, willing and available
caregiver to teach.
Response: Section 40.1.2.4 in Chapter 7 of the Medicare Benefit
Policy Manual (Pub. 100-02) states that where a patient is either
physically or mentally unable to self-inject insulin and there is no
other person who is able and willing to inject the patient, the
injections would be considered a reasonable and necessary skilled
nursing service covered by the Medicare home health benefit. However,
Medicare would not cover this service for a patient who is capable of
learning and self-administering insulin, but refuses to do so, in which
case the HHA may choose to discharge a patient because the payment
source will no longer pay (see Sec. 484.50(d)(2)). However, we believe
that these situations are very rare. We would expect an HHA to explore
all possible avenues to identify one or more individuals who could
administer insulin to the patient as well as all possible options for
convincing a patient to learn the proper self-administration
techniques. We would also expect an HHA to thoroughly document all
steps taken to resolve this issue, converse with the patient regarding
the implications of this decision, communicate with the physician(s)
involved in the patient's home health care and the practitioner who
will be providing follow-up care, and provide the patient with
information regarding other possible sources of care that may meet the
patient's care preferences. For patients with other sources of payment
that would continue to pay for insulin administration to a patient who
is capable of learning self-administration, but refuses to do so, HHAs
are permitted to continue providing services until such time as the
patient is no longer in need of the HHA's services.
Comment: Several commenters supported the proposed requirement that
the plan of care would be required to include measurable outcomes and
goals identified by the HHA and the patient. One commenter stated that
patients and caregivers need to feel their concerns matter in order to
ensure their engagement. However, other commenters expressed concern
and requested additional clarification regarding this proposed
requirement. Commenters sought specific guidance regarding how to
document patient goals, comply with patient-identified goals, and
reconcile potential conflicts between patient-identified goals and the
physician-ordered plan of care. One commenter suggested that HHAs
should be required to establish the plan of care ``in collaboration''
with the patient, rather than ``in partnership'' because acting ``in
partnership'' would increase the burden to HHAs. A single commenter
asserted that patients don't know how to identify quantifiable,
measurable goals.
Response: We appreciate the support of the commenters who submitted
comments on this issue. We did not propose, nor are we finalizing,
specific documentation or implementation requirements for this
provision, as such requirements may impose unnecessary restrictions on
HHAs in achieving the ultimate goal of delivering goal-concordant care.
We acknowledge that patient established goals of care may be verbalized
in a different fashion than those that are established by the
physician(s) involved in the HHA plan of care. Nonetheless, we believe
that patients are capable of establishing goals and that these goals
can be successfully aligned with the goals established by the
physician(s). Where there is direct conflict between a patient-
established goal and a physician-established goal, we would expect the
HHA to educate the patient about why the physician-established goal
must be used to guide the care planning and delivery process. Patients
should also be encouraged to discuss concerns regarding their care
goals with their physician(s). We are finalizing this requirement as
proposed, including use of the phrase ``in partnership.'' We believe
that the phrase ``in partnership'' is equivalent to the suggested
phrase ``in collaboration'', and that there is no difference in burden
based on the use of one phrase over another.
Comment: Some commenters agreed with the proposed requirement that
the plan of care would include measurable outcomes, even suggesting
that such outcomes should be supported by evidence based measures
through the use of standardized test and measures when possible.
However, a single commenter contested the necessity of including
measurable outcomes in a patient's plan of care, stating that there is
not sufficient evidence to support the requirement. Other commenters
expressed concern with the potential implications of the proposed
requirement. These commenters stated that requiring measurable outcomes
may imply that the goal of helping patients safely and effectively
manage their health conditions in a community setting is not sufficient
in itself, and that

[[Page 4535]]

home health services should be available to clients only so long as
they demonstrate continued, quantifiable improvement from those
services. Additionally, commenters expressed concern that working with
the physician to establish such goals would be burdensome.
Response: The concept of measurable outcomes is well established in
health care. For example, measurable outcomes are used in physical
therapy to assess the effectiveness of interventions and are used in
medical social work to assess patient progress in mental health
therapy. Measurable outcomes can be used in home health care to measure
these elements, as well as outcomes related to nursing, patient safety,
and effective self-management, to name just a few. Measurable outcomes
jointly established by the patient, HHA, and physician(s) may include
measures related to self-medication management, avoidance of
unnecessary emergent care visits and hospital admissions, and more. We
do not agree that the phrase ``measurable outcomes'' would in any way
convey the message that the goal of helping patients safely and
effectively manage their health conditions in a community setting is
not sufficient of itself, and that home health services should be
available to clients only so long as they demonstrate continued,
quantifiable improvement from those services, as the commenter
asserted. Furthermore, we do not agree that establishing measurable
outcomes would be burdensome, as this should already be part of
standard care planning activities. Without the pre-establishment of
outcomes, it would be difficult to measure when a patient with a goal
of rehabilitation (the primary population currently served by HHAs) has
made sufficient progress to warrant discharge. Likewise, it would be
difficult to assess whether maintenance services have, in fact,
achieved their maintenance goals.
Comment: A commenter requested clarification of a statement in the
preamble related to the development of measurable outcomes and goals.
The preamble stated, ``An evidence and outcome based approach to
patient care that can be understood by the patient and caregivers, with
specificity of orders, and adherence to best practice interventions to
provide the basis for the development of an optimal plan of care and
goals.'' The commenter requested further explanation regarding evidence
and outcome based approaches, as well as how adherence to best
practices will be measured.
Response: The concept of evidence-based care, an approach to
decision-making in which the clinician uses the best evidence
available, in consultation with the patient, to decide upon the option
which suits that patient best, is well established. For example, in
1997 the Agency for Healthcare Research and Quality launched an
initiative to promote evidence-based patient care through its Evidence-
based Practice Center Program. Among other things, the Program develops
evidence reports on clinical topics and publishes those reports for
public use (see http://www.ahrq.gov/research/findings/evidence-based-reports/overview/ for more details). We expect HHAs to use evidence-
based care, often done through the implementation of best practices, to
improve the experience of care and outcomes of individual patients and
entire patient populations within an HHA's care.
Comment: One commenter requested examples of measurable outcomes,
while another commenter noted that the National Quality Forum recently
released recommendations on quality measurement and dementia that could
be considered by HHAs as they develop outcomes for persons with
dementia and their caregivers. This commenter also urged that patient-
or representative/caregiver-reported outcomes be included as measurable
outcomes in the plan of care, stating that patient and caregiver
perspective is often overlooked in favor of more quantifiable measures.
Response: Measurable outcomes may include anything from an
improvement in ambulation to a stabilizing of blood pressure to an
improvement in self-management. Measurable outcomes must be tailored to
the specific patient, including his or her circumstances, goals, and
condition. We believe that leaving the term as broad as possible is the
most appropriate way to account for this high degree of variability. We
believe that the suggestions provided by the commenter related to
available resources are appropriate and may be of value to HHAs in
implementing this requirement.
Comment: A commenter stated that, in addition to permitting the HHA
and physician to add additional items to the plan of care, the patient
should also be permitted to add items to the plan of care.
Response: HHAs are paid for their services based on a set of
covered services and items that is established by each payment source,
whether Medicare, a Medicaid state plan, private insurance, or the
patient him/herself. While we agree that patients have the right to
state their care preferences and goals (see Sec. 484.50) and that
those preferences and goals should be incorporated into the
individualized plan of care (see Sec. 484.60), we do not agree that
patients should be permitted to add items to the plan of care. Because
we require HHAs to provide all services set out in the plan of care,
such additions could possibly place HHAs in the position of being
required to deliver services and items that are not covered by the
payment source. This would be an unreasonable burden on HHAs.
Comment: Commenters supported the concept of assessing a patient's
risk for re-hospitalization, and several even suggested that the
requirement should apply to all patients rather than be limited to
those patients that are admitted to HHA services following a
hospitalization. One commenter requested clarification regarding the
exact patient population to which the requirement would apply, noting
that not all home care begins immediately following a post-acute
discharge. Commenters stated that identifying a patient's risk for re-
hospitalization and emergency department visits will help improve
patient care and reduce unnecessary and avoidable hospitalizations.
Response: We agree that, for the sake of patient safety and for the
sake of establishing a requirement that can be clearly and equally
applied by all HHAs, this requirement should be applied to all
patients, as all patients have some level of risk for a hospital
admission or emergency department visit. Therefore, we have made a
change to the regulatory text at Sec. 484.60(a)(2)(xii) to apply this
requirement to all HHA admissions. This requirement is consistent with
CMS's focus on reducing preventable re-admissions through a variety of
efforts such as HHA quality measures and CMS payment reforms.
Comment: Commenters identified opportunities for improved clarity
regarding the re-hospitalization risk assessment proposal. Commenters
noted that using ``low, medium, and high'' to rank each patient's risk
may result in significant variation among HHAs because these terms are
subjective and are not defined. One commenter suggested that CMS should
provide additional resources and training to facilitate compliance. A
few commenters suggested that, in order to achieve consistency, there
should be an instrument that has been validated for agencies to use.
Another commenter suggested that this risk assessment should be based
on a Patient Activation Measurement (PAM) score. The commenter stated
that peer-reviewed studies, have identified a strong link

[[Page 4536]]

between patient activation or having the knowledge, skills, and
confidence needed to manage one's health and hospital readmissions. A
study conducted at Boston Medical Center (Journal of Internal Medicine.
February 2014; 29(2): 349-355. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3912296/) found that patients with the lowest levels of
activation had nearly twice the risk of returning to the hospital
within 30 days, compared with patients with the highest levels of
activation. Systematic assessment of a beneficiary's level of
activation and self-management capability can guide more effective
approaches to provider interactions with beneficiaries during in-home
visits by skilled home healthcare professionals. Patients in the lower
two levels of activation are often overwhelmed by their medical
condition and struggle with health-related self-management tasks.
Knowing a beneficiary's level of activation allows home health
providers to tailor information, goals, and action steps to the
abilities of the patient.
Response: We agree that the terms ``low, medium, high'' are not
useful without further definition and standardized measurement tools
that all HHAs would use. Our goal is to bring this issue to the
forefront of patient care, and to assure that, within an HHA, it is
consistently examined and addressed for each patient. While there may
be benefits to establishing more inter-HHA consistency in the
application of this requirement, we do not believe that those benefits
would outweigh the cost of reducing HHA flexibility and innovation to
determine the best possible way to achieve the overall goal of reducing
unnecessary emergent care visits and hospital admissions. Therefore, at
Sec. 484.60(a)(2)(xii) we have removed the terms ``low, medium,
high'', and are not suggesting a specific tool or process at this time.
Comment: The proposed rule included a requirement that all patient
care orders, including verbal orders, must be recorded in the plan of
care. A commenter requested clarification regarding the need for, and
benefit of, including ALL orders (including verbal orders) in the
patient's plan of care. The commenter stated that including all orders
may cause confusion in cases where orders have changed several times
over the course of an episode.
Response: The plan of care is an evolving document that outlines
the patient's journey throughout HHA care and treatment. It is
essential that the plan of care be reflective of past orders and
current orders that are actively ongoing. As new orders are given to
initiate or discontinue an intervention, the plan of care is updated to
reflect those changes. New versions of the plan of care are created as
needed to assure that each clinician is working on the most recent plan
of care, with older versions being filed away in the clinical record in
any manner that meets the needs of the HHA.
Comment: Several commenters expressed concern with the proposed
requirement that drugs, services, and treatments are administered only
as ordered by the physician who is responsible for the home health plan
of care. Commenters stated that patients often have multiple physicians
who order treatments and medications, and that the physician
responsible for the home health plan of care is often not the ordering
physician for every drug and treatment included on the home health plan
of care. According to commenters, the standard practice is that the HHA
informs the physician responsible for the home health plan of care of
all treatments, drugs and services that the patient is receiving, and
if applicable, who the ordering physician is, without requiring that
this physician actually orders all of them himself or herself. Another
commenter stated that in certain situations one physician will not take
responsibility for the orders of another. One commenter stated that the
regulation should be revised to allow communication from the HHA to a
physician group practice, noting that some HHAs provide services
patients who receive care from a group of physicians, and these
patients do not necessarily have a single physician who is responsible
for the plan of care. Commenters suggested that the regulation should
be revised to reflect that drugs, services, and treatments be
administered only as directed by a physician who is responsible for the
care of the patient, and that the physician responsible for the home
health plan of care is made aware of all treatments that the patient is
receiving from the HHA.
Response: We agree that situations may exist in which multiple
physicians are directly involved in providing care for a patient at the
same time, and would thus be in a position to give orders to the HHA
related to the care of a single patient. Furthermore, we agree that it
is appropriate to revise the regulations to permit this arrangement. To
that end, we have revised the requirement specifically related to
physician orders to allow HHAs to accept orders directly from multiple
physicians who are involved in a patient's care at that point in time,
regardless of whether those physicians are part of the same group
practice or not. The physician that is responsible for care of the
condition that led to the initiation of home health care, and is thus
the main physician responsible for the home health plan of care would
have the opportunity to review all orders because all orders from all
physicians must be included in the plan of care (Sec. 484.60(a)(3))
and the plan of care must be reviewed and signed by the physician
responsible for the HHA plan of care (Sec. 484.60(a)). We have also
added new requirements within Sec. 484.60(d), Coordination of care, to
specifically address the role and responsibility of the HHA when it
chooses to accept orders from more than one physician. Specifically, in
addition to the proposed requirements that HHAs would be responsible
for coordinating HHA services and ensuring patient education and
training, we have added new requirements within Sec. 484.60(d) that
HHAs that choose to accept orders from multiple physicians are
responsible for:
(1) Assuring communication with all physicians involved in the plan
of care.
(2) Integrating orders from all physicians involved in the plan of
care to assure the coordination of all services and interventions
provided to the patient.
The purpose of assuring communication and integrating orders is to
avoid duplicate or contradictory physician orders and to assure that
all patient needs are being met (whether directly by the HHA or by the
physicians). We would expect HHAs to have appropriate systems and
processes in place to both identify and resolve conflicting or
duplicative orders. We believe that these expectations are consistent
with the role of the clinical manager at Sec. 484.105(c). In
particular, the clinical manager is responsible for assuring the
development, implementation, and updates of the individualized plan of
care. We believe that, in order to effectively assure the development,
implementation, and updates of the individualized plan of care, there
would have to be communication with all physicians involved in the plan
of care and integration of orders from all physicians involved in the
plan of care to assure the coordination of all services and
interventions provided to the patient. The requirement to integrate
orders from all physicians would include those orders related to
medications. Medication orders may be for long-term maintenance issues
(for example, cholesterol management medications) as well as shorter-
term medications for temporary issues that may or may not be directly
related to the reason that home

[[Page 4537]]

health care was initiated (for example, pain management medications
that may be used in the process of surgical recovery or may be used as
part of a treatment plan for a strained back that the patient just
happened to experience during the time that he or she receives HHA
care). We would continue to expect that all services or interventions
that are ordered are medically necessary, as supported by documentation
in the patient's record, in accordance with the requirements of 42 CFR
409.44 and 409.45.
Comment: One commenter requested clarification regarding the
proposed requirements permitting HHAs to offer vaccinations to patients
in accordance with HHA policy without obtaining a separate physician
order for each patient. The commenter requested that CMS define what
steps in the vaccination process it will hold providers accountable
for, and how CMS will reimburse providers for the vaccine.
Response: The proposed provisions do not reflect a change in our
policy. HHAs are permitted to, in consultation with a physician,
develop a policy for the administration of influenza and pneumococcal
vaccinations without a patient-specific physician order, such as in the
form of a standing order. We would expect that this policy would
address topics such as obtaining patient consent and assuring that it
is safe to administer a vaccination to a given patient prior to
administration. As a medical treatment, this rule would require that
any administered vaccines be documented in the patient's clinical
record in accordance with the requirements of Sec. 484.110(a).
Comment: A few commenters expressed confusion regarding the
relationship between the concept of ``verbal orders'' and orders that
are faxed or otherwise transmitted through other electronic methods.
The commenters were unclear as to whether faxed or other HIPAA-
compliant electronic orders are considered to be ``verbal orders.'' One
commenter suggested that emailed and faxed orders would be followed up
by a written order signed by the physician.
Response: In accordance with the definitions set forth in Sec.
484.2, a verbal order means a physician order that is spoken to
appropriate personnel and later put in writing for the purposes of
documenting as well as establishing or revising the patient's plan of
care. Faxed and other electronic orders are not considered verbal
orders because they do not meet this definition. However, all orders
need to be appropriately authenticated.
Comment: The proposed rule stated that, when services are provided
on the basis of a physician's verbal orders, the clinician receiving
the order(s) must document it in the patient's clinical record, and
sign, date, and time the order(s). While a single commenter supported
this proposal, the vast majority of commenters who submitted comments
regarding this proposal disagreed with the requirement that verbal
orders must be timed, questioning the relevancy and necessity of a
requirement in the home health care setting. A commenter also stated
that it is unclear whether the ``timed'' requirement applies to the
time that the care was provided or activity occurred; when the verbal
order was documented; or when the verbal order was signed by the
physician.
Response: While we acknowledge that most HHA patients do not
typically require rapidly changing orders, we nonetheless believe that
timing the receipt of verbal orders is necessary for those infrequent
occasions when such situations do arise. There are times when a
patient's condition rapidly changes, and clinicians are not necessarily
able to effectively predict when such situations are about to occur.
Therefore, we believe that it is necessary and appropriate to
proactively record the time of day that each verbal order is received
by an HHA clinician from a physician. This requirement corresponds with
the clinical record authentication requirements at Sec. 484.110(b),
which requires all entries in the clinical record to be timed.
Comment: The proposed rule stated that verbal orders must be
authenticated and dated by the physician in accordance with applicable
state laws and regulations, as well as the HHA's internal policies.
Several commenters understood this provision to also require timing of
the physician signature, and disagreed with that idea. One commenter
suggested that the regulation should include a timeframe for physician
signature, while other commenters strongly supported the proposed
deferral to applicable state laws and regulations. One commenter
cautioned states and HHAs against imposing 48 hour timeframes for
physician countersignature of verbal orders, stating that strict
deadlines could impose constraints on physicians' time and patient care
schedules, and could also negatively impact patients and Medicare
expenditures by leading to delays in receiving treatments.
Response: We appreciate the opportunity to clarify the proposed
requirement. We believe that there was some confusion among commenters,
and want to be clear that we did not propose, nor are we finalizing, a
requirement related to a physician timing the signature for a verbal
order. Rather, all verbal orders must be authenticated and dated by the
physician in accordance with applicable state laws and regulations, as
well as the HHA's internal policies. We do not believe that it is
necessary to require a specific timeframe for completing the
authentication process, as in general, this is already effectively
governed by existing state requirements. States and HHAs are permitted
to establish timeframes that meet their needs. We remind HHAs that
authentication must be completed in accordance with established billing
requirements for those patients for whom Medicare is a payment source.
Comment: A commenter expressed concern about the requirement in
Sec. 484.60(b)(4) that a registered nurse or qualified therapist must
document verbal orders. The commenter stated that state law allows
others to receive verbal orders, and that the requirement included in
the proposed regulation would limit an HHA's ability to employ licensed
practical nurses (LPNs).
Response: We agree that there is no health and safety-related
reason to prohibit a LPN from receiving and documenting verbal orders
because LPNs have the necessary training and skill to perform this
function. Therefore, we agree that it is appropriate to allow LPNs to
receive verbal orders as long as the LPN is acting within his or her
state licensure requirements and permitted in accordance with state
scope of practice. This policy is consistent with the regulations for
other providers, such as hospitals and hospice inpatient care
facilities, both of which permit LPNs to receive verbal orders in
accordance with state regulations and the organizations own policies
and procedures. We have revised the regulation text at Sec.
484.60(b)(4) to reflect this change.
Comment: A commenter requested clarification regarding the
relationship between the requirements for care plan reviews and the
timeframes for verbal order countersignature.
Response: All verbal orders must be authenticated and dated by the
physician in accordance with applicable state laws and regulations, as
well as the HHA's internal policies. This requirement applies to verbal
orders that occur at any time during the plan of care development,
implementation, and update cycle.
Comment: Commenters supported the proposed level of physician
involvement in updating the plan of care, as well as the proposed

[[Page 4538]]

requirement for an HHA to communicate with the physician as frequently
as the patient's condition or needs require, when any significant
changes in the patient's health care status occur, and at the time of
discharge from the HHA.
Response: We appreciate the support of these provisions, and are
finalizing these requirements at Sec. 484.60(c) with minor changes to
reflect situations where more than one physician issues orders for
patient care.
Comment: A few commenters suggested that the timeframes for
updating the plan of care should be modified. Commenters suggested that
the regulation should require a plan of care update when there is a
significant change in patient condition, and upon the request of the
patient or representative (if any), but no less frequently than once
every 60 days, beginning with the start of care date.
Response: The HHA should be in regular communication with the
patient and caregiver(s), and must assure that the plan of care is
achieving the goals established by the patient and physician(s).
However, we do not see a reason to explicitly state that the plan of
care should be updated at the request of the patient or representative.
The plan of care is not updated as long as it is meeting the goals
established by the physician(s) and the patient.
Comment: A small number of commenters disagreed with the proposed
requirement that a revised plan of care must reflect current
information from the patient's updated comprehensive assessment.
Commenters stated that a new assessment is not needed when there is a
revised plan of care. Commenters also stated that the proposed
requirement implies that any change in the plan of care, such as a
``minor'' change in orders that does not constitute a ``significant
change in condition'' (for example adjusted medication dose, revised
wound care procedure), requires an updated comprehensive assessment.
Response: The proposed provisions do not reflect a change in our
policy. Current policy requires each HHA to have a policy defining a
significant change in condition that would trigger an update to the
assessment (for example, an initiation or discontinuation of a service,
or a significant improvement or worsening of patient condition not
anticipated in the plan of care). It will be up to each individual HHA
to determine how a significant change in condition is be defined.
Comment: A few commenters sought clarification regarding
communications related to changes in the plan of care and the discharge
plan. We proposed that, if the plan of care is revised due to a change
in patient health status, an HHA must communicate the revisions to the
patient, representative (if any), caregiver, and the physician who is
responsible for the HHA plan of care. We also proposed that any
revisions related to plans for the patient's discharge must be
communicated to the patient, representative, caregiver, the physician
who is responsible for the HHA plan of care, and the patient's primary
care practitioner or other health care professional who will be
responsible for providing care and services to the patient after
discharge from the HHA (if any). Commenters asked the following
questions:
Does this mean that the care plan and discharge summary
must be communicated to a specific provider or can be communicated to
the patient's physicians' practice?
What are the timeframes for when communication regarding
revisions to the plan of care, including discharge planning, need to be
completed and documented?
Can these changes be communicated to the patient and the
physician physically by mail or electronically by email or other secure
electronic means?
Response: In the majority of cases where there is a specific
physician or practitioner with whom to communicate, we would expect
HHAs to communicate directly with that individual. In the small
minority of cases where there is no designated practitioner, HHAs may
communicate with the practitioner group. We are refraining from
specifying timeframes and formats in order to afford HHAs flexibility
in complying with these rules. Patient acuity and patient needs should
drive the timeframes for various communications, with critical and/or
time sensitive information being communicated as quickly as possible
and less critical or time sensitive information being communicated on
an as-needed basis. Likewise, the needs of the recipients should drive
the format of the information and any associated documentation. We do
not believe that it is necessary or appropriate to specify how
information is communicated, provided that the patient's right to a
confidential record is assured in accordance with Sec. 484.50(c)(6).
Comment: Many commenters supported the proposed requirement that an
HHA communicate changes in the plan of care to the patient,
representative (if any), caregiver, and the physician who is
responsible for the HHA plan of care, stating that, in order to
successfully implement the plan of care, everyone involved must be
aware of its contents. A few commenters suggested that the regulation
should clarify that such communications must occur only when there is a
significant change to the plan of care, such as when new orders are
needed from the physician.
Response: We appreciate the support of the commenters for the
requirement that an HHA communicate changes in the plan of care to the
patient, representative (if any), caregiver, and the physician. HHAs
are strongly encouraged to engage patients, representatives, and
caregivers in a conversation about the level of involvement that these
individuals prefer to have in developing and updating the plan of care,
and to act in accordance with those preferences. Some individuals may
prefer to have more involvement, desiring communication regarding every
change, while others may prefer communications regarding changes to
focus only on certain topics or occur no more than once a week. HHAs
would document these preferences and structure their communications
accordingly to meet them. In the absence of such patient-directed
guidelines for communication of changes, the default expectation from
CMS would be that all changes in the plan of care are communicated,
even ``minor'' ones, such as visit frequencies. We remind HHAs that
communications regarding updates to the plan of care to the patient,
representative, or caregivers can be done via telephone or secure
electronic means, with associated documentation in clinical record.
Comment: A commenter requested additional guidance regarding the
manner in which HHAs should document that they communicated changes to
the plan of care to patients, representatives, caregivers, and
physicians. The commenter requested that CMS clarify whether all
changes to the plan of care require the plan of care to be re-signed by
the physician, and if not, explicitly when that would and would not be
required. The commenter also suggested clarifying whether the HHA would
also need the patient and/or the patient's representative to sign the
plan of care to indicate that the HHA has communicated this
information. If a patient signature is not required, the commenter
requested information regarding how HHAs should provide evidence that
the communication occurred.
Response: The signature of the physician who is responsible for
issuing

[[Page 4539]]

orders related to the condition(s) that led to the initiation of home
health services should be on all iterations of the individualized plan
of care for each patient in accordance with the requirements of Sec.
484.60(a). We did not propose, nor are we finalizing, patient signature
requirements for the plan of care. HHAs may document communications
with the patient in regards to the patient's plan of care in any manner
that demonstrates compliance with the communication requirements of
Sec. 484.60. This could include documentation in clinical notes, a
specific section of the clinical record developed for this purpose,
printouts or .pdf versions of secure electronic communications that are
linked to or maintained within the clinical record, or any other method
that could be used to demonstrate compliance.
Comment: Several commenters submitted comments regarding the
proposed care coordination requirements. Commenters supported the goals
of care coordination, stating that communication between the HHA and
other physicians and practitioners is essential for producing the best
possible outcome of care. This is especially true with respect to
issues that are not directly connected to the issues being addressed by
the HHA. Commenters also stated that it was important to coordinate
care with those managing the patient's care after the patient is
discharged from the HHA. Commenters suggested that care coordination
should be led by a clinician, and should be patient centered, goal
oriented, and outcome based. Within the context of this broad support,
a few commenters raised specific concerns and points for additional
clarification. A commenter noted that carrying out these activities is
growing increasingly complex with the emergence of new models of care.
As managed care penetration grows, and new accountable care models gain
traction, patients with complex needs are experiencing care management
and care coordination on a number of fronts. There is a risk of
duplication of effort, and confusing or inconsistent communications to
patients and health care professionals. The commenter suggested that
the regulations should support efforts to streamline requirements among
various health care sources and increase flexibility in implementing
them. Another commenter cautioned that, while it is important to
involve family caregivers, as appropriate, in care coordination and
provide needed training, the coordination of care should also include
appropriate continuity of care and referrals to accessible home and
community-based services in the community, as needed. The commenter
sought to assure that care coordination activities would not be
delegated by an HHA to the caregiver.
Response: We agree with commenters that well implemented care
coordination within an HHA has the potential to improve patient care
and outcomes, and are finalizing this requirement. We note that the
proposed care coordination requirements were specifically referring to
coordinating care within an HHA. We expect HHAs to coordinate the
nursing, therapy, aide, and medical social work services that they
offer, whether these services are provided directly or under
arrangement. In addition to these expectations, as discussed
previously, in response to public comments we are finalizing a new
requirement for HHAs to be in communication with all physicians who are
writing orders related to the HHA plan of care. These activities are
the inherent responsibility of the HHA, and it would not be appropriate
for the HHA to delegate these tasks to a patient or caregiver under any
circumstances. We do not expect HHAs to coordinate the care being
provided by other entities beyond what is included in the HHA plan of
care. For example, we would expect the HHA to coordinate all services
and orders related to wound care for a patient receiving post-operative
hip replacement HHA care. We would not expect the HHA to coordinate
that patient's cardiac care with the patient's cardiologist and other
specialists if this care coordination is already performed by the
physician who is issuing the wound care orders, and if all orders for
all care (wound and otherwise) are issued by that single physician who
assumes the care coordinator role. It is only when HHAs choose to
accept orders from multiple physicians to be included in the plan of
care for a single patient that we would expect HHAs to coordinate the
orders of those physicians. If an HHA chooses place itself in the role
of a direct recipient of orders from multiple physicians, it is
incumbent upon the HHA (as required by Sec. 484.60(d)(2)) to assume
the role of a care coordinator in order to assure that patient needs
are continuously met and that there is no duplication or contradiction
of services. While there may be HHAs that participate in care
coordination programs where the HHA coordinates all aspects of a
patient's care, care coordination programs are separate programs that
have their own requirements, separate from the home health care
requirements set forth in this rule. In these situations, HHAs would be
expected to assume a care coordination role that meets the standards of
the care coordination program in which it is participating, as well as
meeting these HHA CoPs.
Comment: A commenter requested additional guidance on what
constitutes an ``adequate'' level of coordination across all
disciplines and the mechanism to conduct coordination. Another
commenter suggested that the regulation should require HHAs to
specifically document care coordination activities.
Response: Coordination of patient care entails assuring that
patient needs are continually assessed, addressed in the plan of care,
that care is delivered in a timely and effective manner, and that goals
of care are achieved. HHAs may document these activities in a manner
that suits their needs to demonstrate compliance.
Comment: Most commenters who submitted comments related to the
``Care planning, coordination of services, and quality of care''
requirement focused their comments on the proposed discharge summary
requirements. Many of these commenters stated that the regulations
should not include any requirements related to the discharge summary.
Other commenters suggested a pared down list of content elements
focused on the status of the patient at the time of discharge, such as
a current reconciled medication list, a copy of the most recent plan of
care, and recommendations for follow-up care.
Response: We appreciate the many suggestions that commenters
submitted on this topic. Two days prior to publication of the proposed
HHA CoPs, the Improving Medicare Post-Acute Care Transformation Act of
2014 (IMPACT Act) (Pub. L. 113-185) was signed into law. Section 2(a),
which added new section 1899B(i) to the Act, requires hospitals of
various types and HHAs to take into account quality measures, resource
use measures, and other measures to assist patients and their families
during the discharge planning process. We believe that this provision
will encourage hospital patients and their families to become active
participants in the planning of their transition to post-acute care
settings (or between post-acute care settings). This requirement will
allow patients and their families' access to information that will help
them to make informed decisions about their post-acute care, while
addressing their goals of care and treatment preferences. Due to the
very

[[Page 4540]]

close timing of this legislation in reference to publication of the HHA
rule, the proposed HHA rule did not take into account the requirements
of the IMPACT Act. In order to meet the requirements of the IMPACT Act
for HHAs, we have decided to withdraw our proposals related to the
content of the discharge summary. In its place, we are proposing a
separate rule (``Medicare and Medicaid Programs; Revisions to
Requirements for Discharge Planning for Hospitals, Critical Access
Hospitals, and Home Health Agencies,'' November 3, 2015 (80 FR 68126))
that would implement the discharge planning provisions of the IMPACT
Act and would address the content of the HHA discharge summary.
Comment: Many commenters responded to the request for additional
ways to increase and improve HHA-physician communication. Comments
ranged from statements that it is not necessary or desirable to
increase communications between HHAs and physicians to suggestions that
HHAs should be required to have medical directors overseeing clinical
operations. Additional suggestions included: The implementation of
interoperable health records to facilitate timely information exchange;
establishing a demonstration to test the use of licensed practitioners,
such as nurse practitioners, to oversee the home health plan of care;
and aligning physician financial incentives with the goal of reducing
hospital admissions and re-admissions while improving patient outcomes.
Response: The only commenter suggestion that could be implemented
through the CoPs is the suggestion that the regulations should require
each HHA to have a physician medical director. This concept was not
included in any manner in the proposed rule, and its inclusion would be
a significant change. We believe that, should this policy be considered
for implementation, it would be most appropriate to pursue separate
notice and comment rulemaking at a future date. All other suggestions
are beyond the scope of this rule.
Quality Assessment and Performance Improvement (QAPI)
Comment: We received many comments regarding the proposed Quality
Assessment and Performance Improvement (QAPI) requirements. The
comments supported our understanding of data collection as a driving
force in implementing evidence-based healthcare. The commenters stated
that HHAs that are using data to drive organizational change can expect
to improve the quality of care they provide to their patients. Many
commenters appreciated the flexibility of the proposed requirement that
allows HHAs to proactively identify risk areas and performance problems
through the QAPI program. The commenters also supported the concept
that each HHA would be expected to conduct its QAPI program in a way
that best met its needs and the needs of the HHA's patients. However,
we also received several comments that were not supportive of the QAPI
CoP. One commenter stated that QAPI might not be appropriate for a
home-based provider because the type of information collected through
QAPI is geared toward facility-based patients and facility-based
providers. In addition, this commenter stated that QAPI was too
burdensome and too costly relative to any increased benefit it will
provide. One commenter stated that the impact analysis for this
provision was far under their perceived estimate to implement a QAPI
program and the cost proposed by CMS would not allow the HHAs to
produce any credible results that would represent any fundamental
quality improvement change.
Response: We appreciate the support of this proposed requirement,
as it confirms our understanding of current HHA quality practices. We
do not agree with the assertion that QAPI is not appropriate for home-
based providers. Hospices and dialysis providers, both of which include
home-based services within their scope of services, have been
successfully complying with QAPI requirements since 2008. HHAs have an
abundance of standardized data elements and quality measures to select
from in order to facilitate compliance with this requirement. We note
that the impact analysis is neither a minimum nor a maximum level of
effort. It is merely an estimate of the time and associated costs for a
statistically typical HHA to develop and implement a basic QAPI
program. Each HHA, depending on its needs and circumstances, may need
more or less resources than estimated in the impact analysis.
Comment: Several commenters asked for a phased-in implementation
time frame beyond the other HHA regulations. The reasons for the
increased implementation time frame were because many states align
their licensure requirements with some of the federal CoP requirements
and the fact many HHAs do not currently have a comprehensive QAPI
program that meets the standards of the proposed CoP.
Response: We agree that a phased-in implementation time frame is
appropriate for the requirement that HHAs must conduct performance
improvement projects because it will take additional time to collect
the data necessary to identify areas for improvement that are
appropriate for performance improvement. We have added a phase-in to
allow HHAs the time necessary to collect data prior to implementing
performance improvement projects. This allows for a full 12 month time
period between the time that this final rule is published and the time
that HHAs must begin conducting performance improvement projects. All
other QAPI requirements can be implemented within the standard time
frame for implementation of the CoPs as a whole (by July 13, 2017).
Comment: One commenter suggested that CMS utilize the Patient
Activation Measure (PAM) as part of the requirements for HHAs under the
QAPI CoP. The commenter explained that PAM is a 10- or 13-item
questionnaire that assesses an individual's knowledge, skill and
confidence for managing their health and healthcare. They stated the
measure has strong psychometric properties and is being used in
clinical settings around the globe. In a related comment, a commenter
suggested that HHAs should use the ASHA Functional Communication
Measures, and should collect patient-level data related to speech,
language, cognition, and swallowing as areas of focus within their QAPI
programs.
Response: HHAs may choose to use data elements and measures that
meet their quality needs and goals, provided that those data elements
and measures meet the requirements of this final rule.
Comment: One commenter suggested it would be a good idea to have
families or patients participate in a survey about the quality of
service they are receiving from the HHA. They stated that having a
survey like this would allow for CMS and HHAs to understand and receive
feedback on the care they are providing.
Response: We agree that obtaining patient feedback is an important
aspect of assessing the quality of care provided by an HHA. For this
reason, in October 2009 HHAs began participating, on a voluntary basis,
in collecting this information through the Consumer Assessment of
Healthcare Providers and Systems (CAHPS[supreg]) Home Health Care
Survey (HH CAHPS). The survey is designed to measure the experiences of
people receiving home health care from Medicare-certified home health
care agencies. HHA participation in the survey became mandatory in late
2010. (https://homehealthcahps.org/) Information from the survey is
publicly reported on Home Health Compare on the Medicare.gov Web site
as of April

[[Page 4541]]

2012. (https://www.medicare.gov/homehealthcompare/search.html)
Comment: Several commenters urged CMS to consider the development
and use of tools that can be utilized by HHAs and shared with surveyors
to provide additional guidance. Some suggested that OASIS data be used
for QAPI, while others voiced concern over potential problems with
Private Duty Nursing (PDN) patients versus traditional home health
patients when utilizing OASIS data to measure HHA quality. Some
commenters suggested incorporating information from HHA surveys by
State Survey Agencies, and that quality measures should be
differentiated by HHA size (small, large and more complex HHAs).
Response: Accreditation organizations, industry associations,
universities, and other independent entities are all sources of quality
measures, tools, guides, and other resources that HHAs may use to aid
in the implementation of QAPI requirements. OASIS data and survey data
may or may not be an appropriate source of information for specific
quality measures, depending on the data needed. We believe that these
various sources of quality measures and tools make it unnecessary for
us to develop separate tools.
Comment: We received several comments that expressed concern over
the QAPI requirements, suggesting that CMS was providing too much
latitude to HHAs in designing and implementing their QAPI programs. The
commenters stated that such flexibility would allow some HHAs to evade
scrutiny or conveniently brush problems and violations under the rug.
They stated that in the absence of clear expectations, parameters and
standards for enforcement, less scrupulous providers will pay lip
service to QAPI requirements without making a meaningful effort to
address problem areas.
Response: While there may be a subset of providers that attempt to
do the bare minimum to comply with all of the requirements in this
rule, we do not believe that creating a more prescriptive requirement
will enhance overall patient care. Indeed, a prescriptive requirement
would likely lead to rote behaviors that lack the introspective
analysis that QAPI is based on. HHAs would be more likely to just do
something for the sake of compliance, rather than to think about ways
to continually improve. We believe that the HHA survey process, which
includes HHA surveys by State Survey Agencies or accreditation
organizations at least every 36 months, is effective in identifying
substandard providers and prompting the necessary corrections.
Comment: We received several general questions regarding the QAPI
requirements. One commenter asked if an HHA could fulfill the QAPI
requirements if it participated in a larger, system-based improvement
program that was implemented by their parent hospital/health system. A
second commenter asked about what would be considered to be an
``effective'' program. A third commenter stated they believed the
requirements should hold HHAs accountable for complying with the
requirement and not just require that the QAPI program be ``capable of
showing measurable improvement.'' A fourth commenter asked if HHAs
would be considered out of compliance if it chose an area that did not
meet the criteria of high risk, high volume or problem-prone. A fifth
commenter asked about what happens if improvements are not sustained.
Response: A QAPI program must be individualized to the HHA and must
be designed in a manner that will result in improving patient care and
HHA operations. We require that a program be ``capable of showing
measurable improvement'' because, despite an HHA's best efforts, not
all endeavors will result in actual improvements being made. Parts of
quality improvement are trial and error, figuring out which
interventions do and do not improve processes and outcomes. HHAs are
responsible for making all reasonable efforts to collect and analyze
data from a wide variety of sources (including, but not limited to,
patient care records, administrative records, and procurement records)
to assess its operations and care delivery, and for using that data to
develop and analyze performance improvement projects. For this reason,
we believe that it remains appropriate to require that an HHA QAPI
program be ``capable of showing measurable improvement.'' As stated
previously, this rule requires the QAPI program to be individualized to
the HHA. Participation in a larger, system-based improvement program
may or may not satisfy the requirements of this rule, depending on
whether the larger, system-based improvement program addresses the
specific areas of concern or weakness within the HHA component of the
system. HHAs are required to include, at a minimum, those areas that
are high risk, high volume, or problem-prone, and that reflect the
scope, complexity, and past performance of the HHA's services and
operations. If, for example, a system-based program focused on
infection prevention and control, while the HHA's historical area of
weakness is the effectiveness of occupational therapy in achieving
desired outcomes, then participation in the larger, system-based
improvement program would not be considered sufficient to meet the
requirements of this rule. Conversely, if an HHA chose to participate
in the system-based program that focuses on infection prevention and
control in addition to its own separate focus on occupational therapy,
then it could be considered to be in compliance. HHAs may choose to
focus on areas that are not high-risk, high-volume, or problem-prone in
addition to their efforts related to areas that are high-risk, high-
volume, or problem-prone. Regardless of the chosen focus areas, HHAs
are required to implement performance improvement projects, to monitor
their implementation, revise the projects as necessary to achieve
success, and assure that improvements are sustained over time. If
improvements are not sustained over time, we would expect HHAs to
continue to revise their approach as needed until improvements are
sustained.
Comment: We received several comments that suggested we remove or
revise language in the regulations. Several comments asked that CMS
remove or revise the language that used the term ``medical errors.''
They stated ``medical errors'' appears more applicable to hospitals and
there is a legal definition of ``medical error'' now associated with
liability insurance, so they cautioned CMS to use the term carefully.
One commenter suggested the removal of ``hospital admissions/re-
admissions'' and replace it with the terms ``emergent care/re-
hospitalization'' because they pertain more to home health care. One
commenter suggested we revise the requirement ``immediate correction of
any identified problem that directly or potentially threaten the health
and safety of patients'' because these types of situations indicate
``immediate jeopardy'' or emergency and should be corrected immediately
and not necessarily as a result of data collection.
Response: We appreciate the suggestions related to ``medical
errors'' and hospital admissions/re-admissions. In regards to the term
``medical errors'', we are not associating this term with HHA liability
insurance. While there may be liability insurance implications that may
occur as a result of identifying a ``medical error,'' such insurance
issues are not within the scope of this rule. Recognizing and
responding to ``medical errors'' is an essential responsibility of all
HHAs because medical errors are a significant quality

[[Page 4542]]

and safety concern. As for hospital admission/re-admissions, we agree
that using the term emergent/re-hospitalization is acceptable, however,
all three of these areas (hospital admissions, re-admissions and
emergent care) need to be considered by the HHA. We have revised the
regulation at Sec. 484.65 to include emergent care, in addition to
admissions and re-admissions. Lastly, we agree that any immediate
jeopardy situations that are identified, whether through an incident
report, patient complaint, staff observation, or data collection should
be corrected immediately. However, we do not agree that it is
appropriate to revise the regulatory requirement that there must be an
immediate correction of any problem that directly or potentially
threatens the health and safety of patients. A problem that directly or
potentially threatens the health and safety of patients should be
immediately corrected, and we see no reason to change this requirement.
Comment: We received several comments that asked who should work on
QAPI. One commenter stated the preamble mentioned physician
participation but did not include physicians specifically in the
regulatory language. One commenter pointed out that patients, their
representatives and caregivers are not included in the QAPI CoP
requirements.
Response: We do not agree that it is necessary or appropriate to
specify the persons that should be involved in QAPI. Each HHA may
choose different individuals representing different areas of knowledge
and experience in order to achieve their specific QAPI goals. HHAs may
choose to solicit specific information from physicians, patients,
representatives, and caregivers beyond the data that is already
gathered from them to use in QAPI efforts.
Comment: One commenter asked if the elimination of the ``Group of
Professional Personnel'' will eliminate physician involvement. The
commenter stated that the current group of professional personnel
requirement is the only factor that insures a physician has involvement
with the operations of the agency. On the other hand, another commenter
stated that maintaining the group of professional personnel ``was more
a troublesome administrative burden than a mechanism that yielded
demonstrable benefits for patient care.'' This commenter further stated
the QAPI program, based on the concepts articulated in the proposed
rules and prevailing QAPI accreditation standards, provides a better
basis for achievement of patient-focused, performance-based outcomes.
Another commenter stated that the previously-required 60 day summary of
care statement should be part of an HHA's evidence-based program of
quality improvement.
Response: HHAs may choose to involve physicians in their QAPI
efforts, and may benefit from seeking the input of a variety of
physicians, such as those who refer to home health care, those who
manage HHA plans of care, and those who have expertise in quality
measurement and improvement. However, we do not believe that it is
necessary to mandate physician involvement, because this would be a
significant cost to HHAs. Furthermore, HHAs may choose to assess the
timeliness and completeness of HHA-physician communications, in their
many forms, as part of their QAPI programs. We agree that this
measurement and subsequent analysis may be valuable. However, we do not
believe that it is appropriate to mandate such measures because they
may not meet the specific needs of all HHAs.
Comment: One commenter suggested that CMS add a CoP that requires
that every HHA receiving public dollars from Medicare and Medicaid
programs must implement an electronic visit verification mechanism.
They stated they believe this would provide electronic proof and record
accountability that a visit had taken place. In addition, they stated
this would be a common sense best practice approach to prevent fraud,
waste and abuse that all HHAs must comply with in order to participate
in the Medicare programs.
Response: While we agree that electronic visit verification
software may be a helpful tool for HHAs to use, there are no uniform
standards for the implementation of electronic visit verification. In
the absence of these standards, we do not believe that it is
appropriate to mandate the use of electronic visit verification
software.
Comment: We received several comments asking for clarification and
justification for the performance improvement projects. Several
commenters asked that CMS be more specific in the requirement for
performance improvement projects, specifically asking for a prescribed
level of detail regarding their content and frequency. Commenters
suggested that performance improvement projects may be warranted in
response to a deficiency cited by a survey. In addition, commenters
voiced concerns regarding the potential for inconsistent survey
processes and outcomes related to this requirement because the
requirement for QAPI is not prescriptive. One commenter asked why
performance improvement projects are required and expressed concern
that conducting performance improvement projects could distract and
take away from program activities that address critical problems.
Additionally, a commenter observed that the proposed requirement does
not call for the HHA to sustain these improvements. Absent such
requirements, the commenter stated that the time and resources would be
wasted on a short-lived effort whose effect does not last.
Response: The regulation already requires that performance
improvement projects, as part of the overall QAPI program, be focused
on indicators related to improved health outcomes, patient safety, and
quality of care; focused on high risk, high volume, or problem-prone
areas; and that the number and scope of distinct improvement projects
conducted annually be reflective of the scope, complexity, and past
performance of the HHA's services and operations. To be more specific
than these requirements would restrict the flexibility that HHAs need
in order to effectively and efficiently comply with these requirements.
Of particular note, we believe that the requirement to focus on high-
risk, high-volume, and problem-prone areas is the same as focusing on
program activities that address critical problems. Rather than
detracting from such efforts, the rule would require that they receive
the data and resources necessary to develop effective solutions.
Furthermore, the regulation at Sec. 484.65(c)(3) requires that ``The
HHA must take actions aimed at performance improvement, and, after
implementing those actions, the HHA must measure its success and track
performance to ensure that improvements are sustained.'' We believe
that this requirement will assure that HHAs sustain improvements over
time.
Comment: We received various comments on the role of the governing
body in the QAPI CoP. A few commenters stated that they supported the
concept of ``leadership from the top,'' and that the approval of data
collection should be the role of the HHA leaders, not the governing
body. We received comments that asked for clarification regarding the
role of the QAPI Committee, the Professional Advisory Committee, the
Interdisciplinary Record Review Committee and whether one takes the
place of another, whether they could be combined, if there were
expectations as to who served on what committee, how often each
committee would need to meet, whether or not HHAs would need

[[Page 4543]]

a medical director, and what role they would serve in meeting the QAPI
CoPs.
Response: The HHA governing body is responsible for approving data
collection, leaving HHA management responsible for all of the research
and decisions leading up to final approval by the governing body.
Furthermore, these regulations do not require any particular committees
to be used, so we are unable to clarify the roles, schedules, or
compositions of committees that HHAs may choose to develop or maintain.
Additionally, this regulation does not require an HHA to employ a
medical director. If an HHA chooses to employ a medical director, the
HHA would be allowed to incorporate the medical director into the QAPI
program in a manner that it sees fit.
Infection Prevention and Control
Comment: We received many positive comments that supported our new
infection control program requirements. Previously, the home health
regulations only briefly addressed infection control procedures. One
commenter stated they believed incorporating preventive care of
infectious diseases is the best addition to the CoPs. Other commenters
also agreed that infection control requirements will bring the focus of
care back to the patient, and that it will promote and help to improve
quality of care.
Response: We agree with commenters that the infection prevention
and control requirements are an important addition to the HHA CoPs, and
appreciate the support of the commenters.
Comment: Several commenters asked that CMS utilize a phased-in
approach for the infection control program. The rationale for a phased-
in approach was based on the fact that variation exists among home
health agencies with regard to the infection control elements required,
and will require additional resources for the agencies.
Response: This rule will be effective July 13, 2017. We believe
that this time period will be sufficient for HHAs to develop and
implement an infection prevention and control program that complies
with these requirements.
Comment: One commenter suggested that CMS consider the requirement
of an infectious disease specialist in implementing and maintaining
such a program. The commenter believed that having an infectious
disease specialist would help align the infection control efforts
within the broader, integrated network and could be relied upon to lead
the education programs for staff, patients and caregivers.
Response: The services of an infectious disease specialist may be
valuable for HHAs in the development and refinement of infection
prevention and control. However, we do not agree that the services of
an infectious disease specialist are necessary for establishing a
program that is capable of meeting the requirements of this rule. We
believe that non-specialist physicians, advanced practitioners, nurses,
and others have sufficient knowledge and training to create effective
programs without the added cost and logistics of consulting an
infectious disease specialist.
Comment: One commenter asked CMS to clarify the role of the
Infection Control Committee. They asked if it was part of the QAPI or
is it a separate committee.
Response: This rule does not require the use of an infection
control committee. HHAs are permitted to create an infection prevention
and control program using the expertise of all appropriate individuals.
Comment: Several commenters requested clarification on the method,
plan and use of ``standards of practice'' when implementing an
infection control program. They specifically asked for examples of
surveillance activities, which guidelines or current standards of
practice to use, and guidance on the type and amount of education and
whether or not it can be provided verbally or if it must be in writing.
Response: Federal and state agencies such as the Centers for
Disease Control and Prevention and state departments of health, as well
as accreditation organizations and national professional organizations,
have all developed infection prevention and control standards of
practice. There is a wide variety of information on this subject
available for HHAs to choose from in creating their own programs, and
we do not believe that it is appropriate to specify which standards
HHAs must use. We would expect an HHA to be able to identify the source
of the standards it selects and be capable of explaining why those
standards were chosen for incorporation into the HHA's infection
prevention and control program. Similarly, we do not believe that it is
appropriate to specify the form or content of patient and caregiver
education regarding infection prevention and control. The education,
both in content and format, must meet the needs of the patient and
caregivers. This means different things for different individuals. Some
understand better with written instructions while others understand
better with in person demonstrations and still others understand better
with video instructions. The form and content of the education efforts
need to meet the needs of the individual being educated. We would
expect HHAs to document these efforts in a manner that suits the
workflow of the HHA and successfully demonstrate upon survey that the
requirement was met.
Skilled Professional Services
Comment: One commenter suggested that this requirement should be
renamed ``Professional Services'' because use of the term ``skilled''
may be confusing in relationship to coverage requirements.
Additionally, the commenter recommended that CMS develop a more
comprehensive title for Sec. 484.75(b) by combining the language for a
more inclusive responsibility.
Response: The professions included in this section are all
``skilled''; therefore we believe that it is appropriate to maintain
this element of the title. Furthermore, we do not agree that standard
(b) should be re-named, as the content of the standard is directly
related to the responsibilities of skilled professionals.
Comment: While several commenters supported the grouping of
discipline-specific regulations under a single CoP, a small number of
commenters disagreed with this regulatory text organizational
structure. These commenters recommended retaining all of the current
provisions as separate CoPs, and adding new regulatory requirements
within each of those separate CoPs to support interdisciplinary
participation. One commenter was concerned that grouping discipline-
specific regulations under a single CoP would impede interdisciplinary
care by diluting the roles of professionals within the team. One
commenter also asked that ``physician extenders'' be recognized as part
of the interdisciplinary team, while another suggested that physician
services include those services provided by interns and residents.
Response: We appreciate the support for the reorganization of
skilled professional services. We believe it is in the best interest of
the HHA staff that each discipline be held to the same high standard,
and that combining all discipline-specific requirements into a single
standard will help assure that all disciplines are being equally held
to the same expectations. Furthermore, applying the same expectations
to all disciplines will facilitate HHA compliance with the regulations
as well as facilitate survey consistency. We do not agree that holding
all disciplines to the same expectations will dilute the roles of each
discipline. In regard to the

[[Page 4544]]

use of physician extenders, section 1861(m) of the Act specifically
defines HHA services as skilled nursing, PT, OT, SLP, medical social
services, and medical supplies. However, the Act does not include
physician extenders. Therefore, we do not think that it is appropriate
to include these professionals in the ``skilled professional services''
section. Lastly, there is only one place in section 1861(m)(6) of the
Act that refers to HHA physician services. The Act states that ``in the
case of a home health agency which is affiliated or under common
control of a hospital, medical services provided by an intern or
resident-in-training of such hospital, under a teaching program of such
hospital'' are part of HHA services. Since we do not have a specific
requirement for physician services in any part of this rule, they are
otherwise not part of HHA services, and are exceedingly rare.
Therefore, we do not believe that regulatory language is needed beyond
what is already included in the Act to govern these situations.
Home Health Aide Services
Comment: Several commenters offered support for the home health
aide proposed requirements. One commenter states they are pleased CMS
is proposing to enhance the current regulations to require HHAs to take
action when there is a potential or verified deficiency in aide
services. This new monitoring and oversight of aide performance would
help ensure ongoing quality care. Another commenter strongly supports
the incorporation of home health aides into the health care team
process and supports the proposal to add a new home health aide skill
requirement related to recognizing and reporting changes in skin
condition, including pressure ulcers. Lastly, commenters strongly
support the recognition of additional skilled professionals within the
interdisciplinary team and urges CMS to adopt an immediate effective
date for therapists and other appropriate skilled professionals to
determine home health aide assignments.
Response: We appreciate the support of commenters in moving forward
with these changes. While we acknowledge that some HHAs may wish to
implement select changes as soon as possible, most commenters requested
a significant period of time to implement the requirements of this
final rule. To accommodate commenter concerns, we are finalizing a July
13, 2017 effective date. Therefore, the provision permitting therapists
to determine home health aide assignments will be effective July 13,
2017.
We also appreciate the commenters' support for the new home health
aide skill requirement related to recognizing and reporting changes in
skin condition, including pressure ulcers. We believe that it is
important for home health aides to be taught to recognize and report
changes in skin condition; however, it has been brought to our
attention that the skills involved in reporting changes in the
condition of pressure ulcers are beyond the home health aide's normal
scope of practice. Therefore, in light of this information, we are
withdrawing our proposal to require home health aides to be taught to
recognize and report changes in pressure ulcers. The revision will
require only recognizing and reporting changes in skin condition.
Comment: One commenter stated that the regulations for education,
training, competency evaluations, certification and supervisory
requirements for certified home health aides are different in their
state than what is proposed.
Response: We acknowledge that states often have more stringent aide
requirements. In situations where a state has more stringent
requirements for aide education, training, competency evaluations,
certification and supervision, those state requirements would take
precedence over these federal requirements. Likewise, in situations
where the federal requirements are more stringent, those would take
precedence over the more lenient requirements.
Comment: Several commenters expressed concern that the regulation's
attention to home health aide service is excessive. Several other
commenters suggested that the regulations should allow state nursing
boards to set the standards.
Response: Many of the home health aide requirements, such as those
for aide training and entities prohibited from offering training, are
set forth in the Act and, as such, must be included in the regulation.
We have streamlined the home health aide requirements to the greatest
degree possible while still implementing the requirements of the Act
and assuring that all essential components of aide services that lead
to safe and effective patient care are addressed.
Comment: One commenter requested CMS to consider either not
requiring home health aides to obtain CNA certification, or change the
requirements to maintain CNA certification so a home health aide could
maintain CNA certification without undue burden.
Response: To clarify, the proposed regulation does not require CNA
training. Rather, the regulation proposed that CNA training (as opposed
to home health aide training) may be considered as an appropriate
qualification for an individual to be a home health aide.
Comment: A commenter disagreed with the proposed requirement that
the individual complete another aide training program before providing
services if, since the individual's most recent completion of the aide
training program(s), there has been a continuous period of 24
consecutive months during which none of the services furnished by the
individual were for compensation. Similarly another commenter
recommended that flexibility be incorporated into this requirement.
Another commenter stated that the aide 24-month lapse was not
necessary.
Response: This regulatory requirement directly implements section
1891(a)(3)(A) of the Act and cannot be altered via regulation.
Comment: We received many comments requesting clarification on
several different issues related to home health aides. A few commenters
specifically requested clarification on home health aide employment/
training. One commenter asked if a home health aide who had worked for
an HHA for 10 years and then stopped working for the agency for 2 years
to care for an aging parent, would then be required to complete a new
aide training program prior to returning to work for the agency?
Another commenter asked CMS to clarify what happens if an HHA aide
completed another training program but had not furnished home health
aide services for 24 months. This same commenter also requested a
definition of the term ``compensation.''
Response: We appreciate the opportunity to clarify the requirement
related to home health aides. Part of our requirements for home health
aides states, ``A home health aide or nurse aide is not considered to
have completed a training and competency evaluation program if, since
the individual's most recent completion of the program(s), there has
been a continuous period of 24 consecutive months during which no aide
services (personal care services, simple dressing changes, assistance
with medications that are ordinarily self-administered, assistance with
activities that are directly supportive of skilled therapy services,
and routine care of prosthetic and orthotic devices) were furnished for
compensation.'' In the examples from the commenters there was a 24-
month lapse in furnishing services for compensation. This means the

[[Page 4545]]

individual must complete another training and competency evaluation
program, or a competency evaluation program, before providing services.
If an individual has a 24 consecutive month lapse in furnishing aide
services for compensation, regardless of the circumstances surrounding
the lapse, he or she will be required to complete a new training and
competency evaluation program, or a competency evaluation program,
prior to providing aide services on behalf of the HHA. Compensation as
it relates to home health aide means monetary compensation, as set
forth in section 1891(a)(3)(A) of the Act.
Comment: A commenter cautions CMS against using the word
``clinical'' in the standard relating to communication skills. It
created a higher standard of clinical qualifications than may be
required by the state. Instead of ``verbally report clinical
information,'' the commenter suggested, ``verbally reporting
information relevant to the patient's clinical condition.'' In
addition, a commenter expressed concern about the possibility of
increased expectation regarding the aide's capability in preparing
documentation for the clinical record. The commenter asserted that HHA
aides are not ``certified'' and so their level of documentation skills
are not standardized. The commenter asked how a surveyor would assess
the documentation developed by an aide when documentation standards do
not exist for the aide. The commenter also stated that, unlike nurses,
who must meet documentation standards by virtue of licensure, aides do
not have such standards.
Response: We appreciate the opportunity to clarify the requirements
related to HHA aide documentation. We do not agree that the language
change to ``verbally reporting information relevant to the patient's
clinical condition . . .'' is any clearer than what was proposed.
Therefore, no changes will be made. The commenter also stated that HHA
aides are not ``certified'' and so their level of documentation skills
is not ``standard.'' To clarify, aides are expected to function within
their existing state licensure requirements to the extent applicable,
so no higher level of skill is expected than what is already
established under a state's laws and regulations. As for documentation,
this standard is related to the content of the aide training program.
By including ``documentation'' as an element of the basic aide training
program, training in documentation would become standardized, and both
HHAs and surveyors would be able to assess the accuracy and
effectiveness of aide documentation that is produced as a result of
this training. HHAs will be held responsible for the accuracy of
information in the clinical record that is created by HHA aides, in
accordance with the requirements of Sec. 484.110. HHAs will also be
held responsible for assuring that each aide completes, at a minimum, a
competency evaluation to assure that an aide's documentation skills are
sufficient.
Comment: We received several comments regarding HHA aide training.
A few commenters requested clarification on currently employed HHA
aides who have already been through basic training and competency
assessment. Specifically the commenter asked if agencies will need to
implement training regarding skin care, decubitus ulcers and
communication and if that could be met through in-service training.
Other commenters asked CMS to provide greater clarification as to the
requirements regarding home health aide communication skills, including
the required ability to read, write and verbally report clinical
information to patients, representatives and caregivers as well as HHA
staff. Several commenters suggested that the effective date for
compliance be phased in to accommodate those aides currently employed
by the agency to receive updated training in new areas through in-
service training. A few commenters proposed that a certified nurse aide
must successfully complete supplemental training in order to qualify as
a home health aide. One of the commenters went on to suggest that the
content of this training should be set by CMS and approved by the
state.
Response: This rule will be effective on July 13, 2017. We do not
believe that additional time for this provision is necessary because
current HHA aides would only require training on new skills (for
example, recognizing skin changes), which may be done through routine
in-service training. In accordance with the requirements of Sec.
484.80(a), individuals trained as nurse aides are already required to
complete a competency evaluation to assure that they have the skills
appropriate to furnish home health aide services to home health
patients. In accordance with the requirements of Sec. 484.80(c)(4),
any skills for which a HHA aide is evaluated as unsatisfactory may only
be done under the direct supervision of a registered nurse until such
time as he or she successfully completes a subsequent evaluation.
Retraining would be done as needed to assure competency in all required
skill areas. We believe that this competency evaluation process will
assure that nurse aides possess all necessary skills to furnish safe
and appropriate care to home health patients.
Comment: A commenter requested clarification as to whether HHAs
could use in-service education provided by another organization such as
the HHQI national campaign, accompanied by a post test, adding that the
HHA would still provide any educational needs or questions the aide may
have.
Response: We appreciate the opportunity to clarify the requirements
related to HHA aide in-service education. It would be permissible for
HHAs to use in-service education through another organization, as long
as it is under the supervision of an RN.
Comment: A commenter stated that the roles and responsibilities of
the home health aide should be clarified. For example, the proposed
language may be interpreted as allowing home health aides to provide
clinical information to the patient, which the commenter did not
support. In addition, the commenter recommends that this requirement
provide specific direction as to how home health aides are to be
involved on the interdisciplinary team.
Response: We appreciate the opportunity to clarify the requirements
related to home health aide roles and responsibilities. The role of the
aide is governed by the state licensure requirements. Therefore, CMS
believes aides should be able to communicate clinical information to
patients that is within the aide's licensure requirements (for example,
blood pressure). While we understand the request for clarification
related to the home health aide's involvement in the interdisciplinary
team, we believe that being prescriptive on how aides should be
involved in the team could limit the HHA's own creativity, flexibility
and innovation. It is up to the HHA to decide how it would like its
aides to be involved in the interdisciplinary team.
Comment: A commenter stated that Sec. 484.80(g)(3) could be
misinterpreted to imply that the physician-signed plan of care must
specifically identify each individual who would perform all of the
duties set out in subparagraphs (g)(3)(i) through (iv).
Response: We appreciate the opportunity to clarify these
requirements. We would expect the physician-established plan of care to
authorize aide services in general. However, the aide-specific plan of
care would be established by the RN or qualified professional, and
would be expected to contain the level of detail

[[Page 4546]]

set out at subparagraphs (g)(3)(i) through (iv).
Comment: A commenter requested clarification on which professionals
may give written instructions to aides. This commenter stated that many
times OT is involved in preparing the plan of care, but is not involved
for the duration of the care, and thus would not be supervising the
aide.
Response: While written patient care instructions for the aide must
be prepared by a licensed professional, preparing the written care
instructions includes overseeing the contributions from all disciplines
involved in the plan of care and synthesizing those contributions. As a
result, a discipline that is involved in the patient's care for a
portion of their time on service would contribute its information to
the clinician responsible for developing the written instructions.
Comment: We received several comments related to HHA supervision.
One commenter requested clarification on Sec. 484.80, stating ``please
clarify `professional'. Does this mean the actual professional (person)
who completes the home health aide plan of care, or can any
professional by discipline (for example, RN) perform the supervision?''
A commenter suggested that an RN, PT, or OT should be permitted to
supervise home health aides. One commenter requested clarification on
the requirements for supervision of aides caring for skilled care and
non-skilled care, specifically the 14-day versus the 60-day minimum
supervision timeframe requirement. Another commenter asked CMS to
clarify that the CoP requires the aide supervisor make at least one
home visit for each non-skilled case every 60 days rather than one home
visit per home health aide every 60 days. Some commenters were opposed
to the 14-day supervisory aide visit, requesting that we remove the
timeframe entirely, while others stated that phrasing the time frame as
``every 2 weeks'' provides the agency with more flexibility. Other
commenters stated that it is more practical to allow home health aide
supervision to be performed during a regularly scheduled skilled visit
and/or to occur when the home health aide is actually present in the
patient's home, while another commenter noted that skilled visits may
occur on an infrequent basis, such as every 3 weeks. Some commenters
stated that requiring the aide supervision to occur onsite, as opposed
to being completed via a phone call, adds undue burden on the HHA in
the form of non-billable nursing visits.
Response: We appreciate the opportunity to clarify the requirements
related to home health aide supervision. As originally proposed, the
requirement expected that written patient care instructions for the
aide would be prepared by the same clinician who would supervise the
aide. However, the proposed requirement generated significant
confusion, and we believe that it should be revised to be simpler. To
that end, we have removed the requirement that written patient care
instructions for the aide would be prepared by the same clinician who
would supervise the aide. In its place, we are finalizing a requirement
that the skilled professional who supervises aide services must be
familiar with the patient, the patient's plan of care, and the written
patient care instructions described in Sec. 484.80(g). This revision
accomplishes the same goal of assuring that the skilled professional
responsible for supervision has all of the information necessary to
effectively supervise the aide's services while removing the confusing
regulatory language that was originally proposed.
We also appreciate the opportunity to clarify the aide supervision
timeframes. If the patient is receiving skilled visits by an RN, PT,
OT, SLP, then a supervisory visit is required at least once every 14
days. If the patient is receiving non skilled visits, meaning that RN,
PT, OT, or SLP services are not being provided to that patient during
that episode of care, then a supervisory visit is required every 60
days for each patient. While we acknowledge the request to change the
``every 14 days'' to ``every 2 weeks,'' we disagree that this is an
appropriate substitute. The 14-day requirement provides a more reliably
frequent supervision schedule, whereas ``every 2 weeks'' creates the
possibility for excessively long gaps between supervisory visits.
Lastly, we believe that supervision by phone is not adequate. Without
the supervisor actually seeing the patient in person, the onus is
placed on the patient to report substandard care. The patient is not
necessarily qualified to recognize when standards of practice are not
followed. It is the responsibility of the HHA to ensure patient care is
being delivered according to best practices, as well as agency policies
and procedures. However, if a patient or representative report a
problem related to the delivery of aide services, the expectation would
be that the problem is noted by the supervisor and an onsite
supervisory visit to observe aide serves would occur. We believe in-
person supervision is in the best interest of the patient, ensuring
quality health care in a safe environment.
Comment: A commenter stated that they did not agree that if an aide
performed task(s) unsatisfactorily, only an RN could subsequently
supervise (rather than a LPN), stating that both RNs and LPNs are
qualified to supervise home health aides. The commenter proposes that
CMS consider allowing for the RN or LPN to be able to assess the aide's
proficiency of the task in a laboratory setting in addition to the
patient's home. Another commenter recommended that remediation on the
skill that was deemed deficient be required, rather than a complete
competency evaluation.
Response: A registered nurse is responsible for overall aide
supervision; therefore we believe that it is appropriate to require
that a registered nurse must be responsible for supervising an aide in
a task for which the aide's skills have been determined to be
unsatisfactory. In addition to this level of supervision, a competency
evaluation is necessary in situations where an aide's skill is noted to
be unsatisfactory because a deficiency in one skill area may indicate
higher likelihood of deficiencies in the aide's other skill areas. A
competency evaluation would provide HHAs the opportunity to note any
additional skill deficiencies, as well as the opportunity to reteach
aides on unsatisfactory skills, thus assuring safer patient care.
Comment: One commenter requested clarification regarding the
wording of Sec. 484.80(h)(1)(iii), stating that this requirement may
be interpreted as either requiring the HHA to provide an annual on-site
visit to one of the home health aide's patients while the aide is
working or that the HHA has to do an annual visit on each patient being
seen by each home health aide. The commenter also expressed concern
that in Sec. 484.80(h)(1)(ii), the term ``potential deficiency'' is
undefined and lacks a timeframe for what and when potential
deficiencies would require a follow-up visit by the supervisor. They
recommended that CMS change the term ``potential deficiency'' to a more
solid term necessitating follow-up such as ``identified deficiency.''
The commenter also requested further clarification of this requirement
by including a time frame for the supervisor's site visit and adding
this time frame requirement to Sec. 484.80(h)(3).
Response: We appreciate the opportunity to clarify the requirements
related to the aide supervisory visits. To clarify, the intent of this
standard is to require supervision of each aide with at least one
patient every year. We agree with the comments that the term
``potential deficiency'' may be misleading. Therefore we are amending

[[Page 4547]]

the language to state ``area of concern'', which is also consistent
with the way we express this same concept in the hospice CoPs. Lastly,
we disagree with the commenters suggestion to include a time frame for
the supervisor's site visit and adding this time frame requirement to
Sec. 484.80(h)(3). We want to ensure the necessary flexibility to
account for variations in aide visit frequencies to the patient's home,
as some patients have more frequent aide visits while others have less
frequent aide visits. We also want to allow HHAs to tailor the timing
of the direct supervision to the urgency of the area(s) of concern,
with those that may affect patient safety or outcomes requiring a
faster response time.
Comment: One commenter requested clarification on whether the
supervision elements set forth in (h)(4)(i) through (vi) must be
documented on each aide supervisory visit. Lastly, one commenter
requested clarification on what is meant by ``demonstrate specific
communication skills''?
Response: All elements set forth in paragraph (h)(4) need to be
accounted for in each and every supervisory visit. In other words, each
supervisory visit would need to provide for and document supervision
related to: Following the patient's plan of care for completion of
tasks assigned to a home health aide by the registered nurse or other
appropriate skilled professional; maintaining an open communication
process with the patient, representative (if any), caregivers, and
family; demonstrating competency with assigned tasks; complying with
infection prevention and control policies and procedures; reporting
changes in the patient's condition; and honoring patient rights. The
phrase ``demonstrate specific communication skills'' was never used in
the proposed rule, so we are unable to clarify its meaning or intent.
Compliance With Federal, State, and Local Laws and Regulations Related
to Health and Safety of Patients
Comment: We received several comments regarding lab services,
specifically, the prohibition on substituting home health agency
equipment for patient's equipment. Several commenters suggested that
CMS allow HHAs the flexibility of using agency equipment based on
individual patient need and with the patient's consent when assisting
with self-testing. A few commenters requested clarification regarding
situations when a patient could not afford equipment, or when testing
would be for a short period of time. Commenters also asked if testing
would be covered by a CLIA waiver, and, if an agency does not have a
CLIA waiver, would they be covered to use their own equipment. Another
commenter asked whether a patient's refusal to obtain equipment would
be a reason to discharge for cause.
Response: We proposed and are finalizing a requirement that HHAs
may not substitute HHA-owned self-administered testing equipment for
patient-owned self-administered testing equipment. As stated in the
preamble to the proposed rule, ``Agencies may also use their own self-
administered testing equipment for a short, defined period of time when
the patient has not yet obtained his or her own testing equipment, such
as in the days immediately following physician orders to obtain the
testing equipment when a patient may not have the time and resources
immediately available to complete the process. We would expect the HHA
to use available resources to assist the patient in obtaining his or
her own testing equipment as quickly as possible.'' We believe that
this establishes a reasonable expectation for the use of HHA owned
self-administered testing equipment on a short-term basis while a
patient obtains his or her own equipment. HHAs are expected to help
patients identify and access existing resources that mitigate or
alleviate any potential barriers to obtaining this essential equipment.
We believe that enabling patients to use their own equipment will
improve the quality of care management that they experience and will
avoid the potential for a patient to not have access to any testing
equipment in emergency situations when HHA staff may not be immediately
available to provide it. In cases specifically related to the use of
self-administered testing equipment for purposes of blood glucose
monitoring, if, despite all HHA efforts to help patients identify and
access existing resources that mitigate or alleviate any potential
barriers to obtaining this essential equipment, a patient refuses to
obtain his or her own testing equipment, and if the patient is
receiving the Medicare home health benefit, then the refusal to obtain
self-administered testing could be grounds for patient discharge.
Daily, and multiple daily visits for purposes of blood glucose
monitoring over a long period of time would not meet the criteria for
coverage of Medicare home health services under section 1861(m) of the
Act, which prohibits payment for services that are more than part-time
or intermittent. Therefore, an HHA would be permitted to discharge the
patient because the payment source will no longer pay (see Sec.
484.50(d)(2)). However, we believe that these situations are very rare.
We would expect an HHA to thoroughly document all steps taken to
resolve this issue, converse with the patient regarding the
implications of this decision, communicate with the physician
responsible for the home health plan of care and the practitioner who
will be providing follow-up care, and provide the patient with
information regarding other possible sources of care that may meet the
patient's care preferences.
If the HHA is only assisting an individual in self-administering a
test with an appliance that has been cleared for that purpose by the
Food and Drug Administration (regardless of appliance ownership
status), the testing self-administration assistance is not required to
be in compliance with the applicable requirements of part 493 of this
chapter. However, if the HHA engages in laboratory testing outside of
the context of assisting an individual in self-administering a test
with an appliance that has been cleared for that purpose by the Food
and Drug Administration, then the testing must be in compliance with
all applicable requirements of part 493 of this chapter.
Organization and Administration of Services
Comment: While one commenter strongly supported the proposed
requirement that an HHA organize, manage and administer its resources
to attain and maintain the highest practicable functional capacity for
each patient's medical, nursing and rehabilitative needs as indicated
by the plan of care, including overcoming those deficits that led to
the patient's need for home health services, another commenter
disagreed with this proposal. The commenter recommended revising the
requirement from ``overcoming those deficits that led to the patient's
need for home health services'' to ``providing optimal care to meet
patient's identified needs.''
Response: We agree that revising this statement is appropriate to
reflect the broad scope of HHA services that may be provided, including
maintenance services. The revised is as follows, ``The HHA must
organize, manage, and administer its resources to attain and maintain
the highest practicable functional capacity, including providing
optimal care to achieve the goals and outcomes identified in the
patient's plan of care, for each patient's medical, nursing, and
rehabilitative needs.''
Comment: A commenter recommended a total revision of the

[[Page 4548]]

organization and administration requirements in a manner that removes
established roles (for example, administrator and clinical manager) in
favor of a structure that focuses on parent offices, where non-patient
care administrative functions are performed and service locations from
which patient care functions are performed.
Response: A revision of this extent would be a significant
departure from the original proposal. Thus, we believe that, should we
choose to act upon this recommendation, such actions would be most
appropriately undertaken in separate rulemaking to allow all interested
parties the opportunity to comment on such changes.
Comment: Several commenters suggested that the regulations should
require an HHA to have a physician that serves as the HHA medical
director, similar to what is already required in the regulations for
nursing homes and hospices. Commenters suggested that the medical
director be responsible for the following:
Implementation of patient care policies;
Coordination of medical care within the HHA;
Coordination and oversight of related practitioners;
Clinical leadership regarding application of current
standards of practice for patient care and new or proposed treatments,
practices, and approaches to care;
Promoting attainment of optimal patient outcomes;
Serving as a clinical resource when attending physicians
are unavailable to ensure that urgent matters are addressed;
Diagnosing changes in patient condition;
Linking the HHA to the physician community to improve HHA-
physician relationships; and
Providing input for the HHA's QAPI program.

Additionally, commenters requested that the relationship between the
medical director and the governing body be defined.
Response: A new requirement of this magnitude, both in terms of
potential effect on HHA daily operations and HHA costs, would be a
significant departure from the original proposal. Thus, we believe
that, should we choose to act upon this recommendation, such actions
would be most appropriately undertaken in separate notice and comment
rulemaking to allow all interested parties the opportunity to comment
on such changes.
Comment: Commenters agreed with the proposed role of the governing
body, but asked for clarification regarding the composition of the
group. A commenter asked if the Professional Advisory Committee could
be considered the governing body for purposes of this rule. Commenters
also asked if there were specific disciplines that would be expected to
be represented in the membership of the governing body and if there
were specific requirements for how often the governing body would need
to meet. Lastly, commenters asked for further explanation of the
proposal that the governing body would assume ``full legal authority''
for the HHA.
Response: An HHA may establish a governing body composed of
individuals of its choosing. The individuals that comprise the
governing body are those who have the legal authority to assume
responsibility for assuring that management and operation of the HHA is
effective and operating within all legal bounds. Those individuals
could be members of the previously-required Professional Advisory
Committee, but that is not a requirement.
Comment: Many commenters submitted comments regarding the proposed
requirements for HHA administrators. Of those commenters, many
requested clarification on whether a single administrator would be
permitted to oversee the operations of multiple HHAs. Commenters
suggested that HHAs should be permitted to use this arrangement if it
could be demonstrated that the administrator could fully meet the
requirements of the duties set forth in the proposed rule. Commenters
suggested that, in order to permit this arrangement, the regulation
should be revised to clarify that the administrator be immediately
available ``in person or by telecommunications.''
Response: The HHA administrator is required, among other things, to
be responsible for all day to day operations of the HHA (Sec. 484.110)
and to be available to patients, representatives, and caregivers to
receive complaints (Sec. 484.50(c)(3)). Our expectation is that the
administrator will be actively involved in the daily responsibilities
of running the HHA, and that HHAs will be able to demonstrate such
involvement upon survey. We do not specify the manner in which this
daily involvement must occur. We did not propose, nor are we
finalizing, a requirement that each HHA have a full-time administrator.
Therefore, it is permissible within these regulations for an
administrator to work part-time for more than one HHA. However, we
believe that the expectation of active involvement in daily operations
and regular availability to patients, caregivers, and representatives
would be difficult, if not impossible, for an administrator to meet if
he or she is responsible for operating numerous HHAs on any given day.
Comment: A commenter suggested that the role of the administrator
should focus on the function of the HHA, assuring accountability to the
governing body, and managing problems that cannot be resolved on a
clinical level. Another commenter suggested that the role of the
administrator should include responsibility for acting as liaison with
the governing body, employing qualified personnel, ensuring adequate
staff education, and conducting evaluations.
Response: We agree that the administrator should be accountable to
and should report information to the governing body, and have added
this requirement to the final rule. We also agree that assuring that
the HHA employs qualified personnel is a responsibility of the HHA
administrator, and have made this change. This is particularly
important for the hiring and oversight of all management roles within
the HHA. We believe that this concept includes assuring the proper
education and training of those staff being hired. Furthermore, we
agree that managing problems that cannot be resolved on a clinical
level is part of the role of the administrator. However, we believe
that this concept is already embodied in the requirement that the
administrator must be responsible for all day-to-day operations of the
HHA. We do not agree that an HHA administrator would be responsible for
conducting staff evaluations, as directly evaluating all staff would be
an inefficient use of administrator resources, and would likely be the
appropriate responsibility of other managers within the organization.
Comment: A commenter suggested that the regulations should require
an HHA to have a qualified professional clinician available to provide
clinical oversight during all operating hours. The commenter noted that
the current HHA regulations require a supervising physician or nurse,
or equally qualified person, to be available at all times during
operating hours. The proposed regulation requires the administrator
(who may or may not be a clinician), or a pre-designated person who is
a skilled professional, be available during operating hours. The
proposed regulation did not require the clinical manager (who is a
registered nurse or physician) to be available during operating hours,
and did not require a designee in the clinical manager's absence.
Therefore, the commenter stated that there exists the potential for

[[Page 4549]]

a home health agency to be operating without the direction of a
clinician during operating hours. For example, when the administrator
is available, the proposed rule does not specify the need for any pre-
designated skilled professional to be available as well. If the
administrator is not a clinician, and the clinical manager is not on
duty, the home health agency would be operating without a designated
clinical manager.
Response: We agree with the commenter that, as originally proposed,
the regulations created the potential for a situation where a home
health agency would be operating without a designated clinician serving
in a manager role. This was not our intent, and we greatly appreciate
the commenter's insight into this matter. We believe that a gap in
clinical leadership would pose a threat to patient health and safety,
as clinicians in the field would not necessarily have ready access to
clinical management expertise and guidance when needed. In order to
remedy this oversight, we have revised the regulatory text at Sec.
484.105(b)(1)(iii) to require that a clinical manager, rather than a
skilled professional, be available during all operating hours.
Comment: Many commenters requested additional information regarding
the process for designating an individual to act on behalf of the
administrator in his or her absence. Commenters asked whether the
person designated to fill the role of the administrator, also referred
to as the administrator designee, would need to be registered with the
State Survey Agency. Commenters also asked for information regarding
the timing of the designation, wanting to know whether it could be done
a few days prior to the administrator being on planned leave. In
addition, commenters made suggestions regarding those responsible for
authorizing the administrator designee. One commenter suggested that
the administrator should be permitted to authorize the designee, while
another commenter suggested that any one member of the governing body
should be allowed to authorize the administrator designee.
Response: Section 484.100(a)(2), which implements section
1891(a)(2) of the Act, requires disclosure of certain specified
information regarding an officer, a director, an agent, or a managing
employee of the HHA. This statutory authority does not extend to
individuals who may act in a management capacity on an episodic basis
for a short period of time in the administrator's absence (for example,
2 weeks a year while the administrator is on vacation and on an
occasional basis when the administrator is ill). However, if an
individual were to act in a managing employee capacity as the
administrator designee on a frequent or regularly scheduled basis (for
example, 1 day a week every week, a few hours each day, or 2 weeks out
of each month), then that individual would be a managing employee, and
the HHA would be expected to disclose the required information in
accordance with Sec. 484.100(a). The timeframe for pre-designating the
individual who will be responsible for fulfilling the role of the
administrator in his or her absence should be established in each HHA's
own policies and procedures. We note that pre-designation needs to be
by both the administrator and the governing body as a whole. The time
necessary to obtain governing body approval for the designation should
be factored into the HHA's timeframe as established in its policies and
procedures. The goal of this requirement is to provide management
continuity within the HHA to the greatest degree possible. HHA staff
should know and be able to verbalize upon interview whom the pre-
designated individual(s) is/are for this role.
Comment: Several commenters made suggestions related to the number
of administrator designees that an HHA should be permitted to have.
Commenters agreed that having one administrator and one administrator
designee may not be sufficient to allow for situations of illness,
planned vacations, and various other factors. Some commenters suggested
that three administrator designees may be appropriate, while others
suggested having no limits to the number of designees that an HHA may
select. One commenter suggested that, rather than have the governing
body approve a single designated back up person to function in the
absence of the administrator, the regulation should allow the governing
body to approve the HHA's policy outlining how administrative oversight
will be transferred in the absence of the administrator.
Response: The number of administrator designees should be
determined by HHA needs and set forth in each HHA's policies and
procedures. As stated previously, the goal is to provide continuity
within the HHA to the greatest degree possible. HHA staff should know
and be able to indicate to a surveyor whom the pre-designated
individual(s) is/are for this role. We are retaining the requirement
that the governing body must approve the pre-designated individual(s).
The governing body is responsible for the administrator's appointment,
and should be similarly responsible for the designee's appointment.
Comment: A commenter suggested that the regulation should clearly
permit the clinical manager to serve as the administrator designee, as
long as he or she meets the qualifications for the administrator as
described in Sec. 484.115(a).
Response: The clinical manager may be the designee, as long as he
or she meets the personnel qualifications to do so. However, it would
not be appropriate to specify this in the regulatory text, as such an
addition may inaccurately imply that others within the HHA who also
meet the personnel requirements would not be permitted to be the
designee.
Comment: A commenter suggested that the term ``equally qualified
substitute'' be used in place of ``pre-designated person'' to describe
the individual who fills the administrator role in the absence of the
administrator.
Response: We believe that both the ``qualified'' and ``pre-
designated'' nature of the individual should be included in the
regulation, and have added ``qualified'' to the regulatory text. An
individual would be considered ``qualified'' to be the ``pre-designated
individual'' by meeting the personnel qualifications for the
administrator role as set forth in Sec. 484.115(a).
Comment: A commenter requested clarification of the phrase
``operating hours'' as it was used in terms of the availability of the
administrator. The commenter stated that HHAs typically have a nurse
available to see patients 24 hours per day, and wanted to know if this
availability would also mean that the administrator must be available
24 hours a day.
Response: As currently stated in the HHA interpretive guidelines
(http://cms.hhs.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_b_hha.pdf), the term ``operating hours'' means all
hours that staff from the agency are providing services to patients.
For the sake of consistency, we intend to maintain this understanding
of the term.
Comment: We received many comments related to the proposed
requirement that each HHA have a clinical manager who is responsible
for several duties. Many of these commenters were supportive of the new
requirement, stating that it more clearly articulates the
responsibility of the former supervising physician or supervising nurse
role, ensuring that patient needs are continually assessed, and
ensuring coordination of care,

[[Page 4550]]

coordination of referrals, and updating of plans, etc. While some
commenters suggested that the role be eliminated altogether, other
commenters sought clarification regarding its function, goals, and
operational implementation. A commenter asked if this role was intended
to be filled by the individual who would provide hands-on care in the
field, or if it could be filled by a supervisor who may not be out in
the field. Another commenter expressed a similar concern, asking
whether the clinical manager would be responsible for oversight of
certain agency functions (for example, making patient and personnel
assignments, coordinating referrals, and assuring that patient needs
were continually assessed) or whether the clinical manager would have
to perform the functions himself. Some commenters asked whether
multiple individuals would be permitted to fulfill the clinical manager
role, noting that in large HHAs it may be difficult for one single
individual to perform all of the proposed duties. Some suggested that
multiple people could all do the same job, each for an assigned subset
of the HHA's patient population, while others suggested that multiple
people could divide the duties of the clinical manager role, such as
one clinical manager is responsible for oversight of personnel and
another clinical manager is responsible for patient care services.
Other commenters suggested that the clinical manager should be
permitted to delegate to other individuals, both clinical and non-
clinical, to carry out the duties for which the clinical manager has
oversight responsibility. Some commenters supported the idea that the
clinical manager and the administrator should be separate roles filled
by separate individuals, while other commenters stated that the roles
should be permitted to be combined and filled by a single person.
Response: The clinical manager requirement is set forth as a list
of responsibilities, such as coordinating patient care and referrals
(Sec. 484.105(c)), in order to allow HHAs flexibility in its
implementation. In a small HHA one clinical manager may fulfill all of
these roles and for all patients. In a larger HHA, multiple clinical
managers may divide up the HHA's caseload, and each clinical manager
takes responsibility for assuring all of these functions for his or her
caseload. Alternatively an HHA may have one clinical manager that
delegates different aspects of the clinical manager role to different
individuals, assuring that each individual performs the necessary
duties and functions. The organizational structure for each HHA will
vary, as set forth in each HHA's own policies and procedures. While we
believe that it would be rare for a single individual to be capable of
effectively fulfilling all of the responsibilities of the administrator
and the clinical manager for an entire HHA, this rule would not
prohibit this arrangement, provided that the individual meets the
personnel qualifications for both roles as set forth in Sec. 484.115
and the quality of care provided to patients is not compromised.
However, we believe that in the vast majority of situations, HHAs will
find it necessary to have at least two individuals fulfilling the
administrator and clinical manager responsibilities separately.
Comment: Numerous commenters suggested that, in addition to
permitting a registered nurse or a physician to fill the clinical
manager role, the regulation should also permit a physical therapist,
speech-language pathologist, occupational therapist, audiologist, or
social worker to fill the clinical manager role.
Response: We agree that these skilled professionals may have the
appropriate qualifications to fill this role. HHAs will be responsible
for assuring that any skilled professional filling the role of the
clinical manager has the necessary clinical, managerial, and
communication skills needed to successfully fulfill his or her
responsibilities as a clinical manager. The regulatory text regarding
the qualifications for a clinical manager has been revised accordingly,
and has been moved to the ``Personnel Qualifications'' section of the
rule at Sec. 484.115.
Comment: A few commenters opposed the proposal that the clinical
manager be responsible for assuring the development of personnel
qualifications and policies. Commenters stated that this is the role of
the Human Resources staff, which has specialty knowledge regarding the
legal rights and obligations of professionals relative to their
employment with the organization. Commenters suggested that the
development of personnel qualifications and policies should be the
responsibility of the administrator and the human resources director,
with approval from the governing body. Commenters also suggested that
clinical managers should express the needs of the clinical program to
the Human Resources staff so that those needs could be reflected in
personnel policies (including, but not limited to, job duties, job
knowledge, expectations relating to the submission of clinical notes,
productivity expectations, and hours of work). These commenters
suggested that it would be more appropriate to require that the
clinical manager collaborate with the administrator regarding the
development of personnel qualifications and policies.
Response: We agree that assuring the development of personnel
qualifications, and policies and procedures, is a task more
appropriately assigned to the administrator, rather than the clinical
manager. We have revised the regulatory requirement at Sec.
484.105(b)(1)(iv) accordingly. The administrator may choose to delegate
these tasks to others, including the clinical manager, as appropriate,
while retaining the responsibility for assuring that tasks are
completed and duties performed.
Comment: A commenter recommended that the clinical manager be
responsible for ``supervision of staff.''
Response: Both the proposed and final rule require that the
clinical manager provide oversight of personnel. We believe that the
broad concept of ``oversight'' already includes the narrower concept of
``supervision.'' The extent to which the clinical manager directly
supervises personnel or delegates such functions to others, while
maintaining responsibility for assuring that supervision is done
appropriately, would be left to the discretion of HHAs as established
in their individual organization structures, as well as their own
policies and procedures.
Comment: A few commenters suggested alternate phrasing for the
clinical manager requirement in a way that avoids creating a specific
management position. While the commenters supported the concept of HHA
staff members performing the duties set forth in the proposed rule,
they opposed establishment of a specific managerial role for those
duties. Commenters suggested that the regulation should identify the
functions that need to be performed without using the ``clinical
manager'' title, and require that ``a designated HHA staff member'' who
is a qualified licensed physician or registered nurse provide
oversight. One commenter suggested that the regulation should be re-
named ``Oversight of Patient Care Services and Personnel.''
Response: As stated in the preamble of the proposed rule, our goal
is to consolidate under the direct responsibility and authority of HHA
management those areas that receive the most frequent deficiency
citations. We believe that the clinical manager role is essential for
managing the complex, interdisciplinary care of home health patients.
Although the current HHA rule

[[Page 4551]]

addresses these issues, it does so in a decentralized manner that has
not consistently led to the patient care outcomes that we seek to
achieve in this rule. Six of the twenty most frequently cited survey
deficiencies center on the need for patient care coordination and
implementation, including the most frequently cited deficiency related
to ensuring that each patient has a written and updated plan of care.
These frequent deficiency citations indicate that patient care, as
structured under the current CoPs, is not being sufficiently planned,
coordinated, and implemented to ensure the highest quality care for all
HHA patients at all times. As such, we believe that a new approach is
needed in order to consistently achieve improved patient outcomes, and
that consolidating these frequently deficient areas under the overall
responsibility of a designated management position will address this
need. HHAs may choose to organize one or more clinical managers in a
manner that meets their needs, but we believe that this designated
position is essential.
Comment: A few commenters expressed strong support for the proposed
parent-branch relationship, particularly the proposal to remove
distance between locations as a consideration in the branch approval
process, stating that, distance should not be a consideration as long
as the parent can demonstrate administrative control over the branch.
Commenters also supported the proposed requirement that the parent
office has direct day-to-day control and direct supervision of all
activities performed and services provided by/from the branch office,
including all contracts, personnel oversight, plans of care, services,
quality control, etc. However, one commenter stated that the proposed
rule did not go far enough in abandoning geography as an organizational
consideration. The commenter stated that advancements in technology
available to HHAs, including IT enhanced functions like clinical
software (including, but not limited to, assessments, plan of care, and
scheduling), IT support, payroll, communications, accounting/billing
and many administrative functions, such as HR administration, insurance
and strategic planning, are amenable to centralized configuration for
multiple service locations, as opposed to decentralized provision of
services and day-to-day supervision of services.
Response: We appreciate the support of most commenters, and believe
that the proposed, and finalized, requirements strike an appropriate
balance between the need for HHA flexibility in management and
structure, and the need to assure accountability throughout an
organization and its many possible locations in a manner that assures
patient safety and high quality patient care.
Comment: While some commenters supported the proposal to
discontinue the use of subunits, many commenters posed logistical
questions regarding the conversion of existing subunits to branches or
independent HHAs. One commenter indicated that its ``branches''
currently have their own provider number or NPI, and asked whether
those ``branches'' that currently do have their own NPI will be
required to be registered as a separate agencies. Other commenters
noted that the current CMS Manuals indicate that there is a process for
the conversion of a branch to a subunit; however, those Manuals are
silent on the process for the conversion of a subunit to a branch or to
a parent HHA. In light of this, commenters posed the following
questions:
How will the transition need to occur for patients who
span the conversion in terms of claim submission? Will agencies need to
close the patient under the subunit provider number and re-open the
patient's care under the parent provider number? Will that require a
new start of care and associated face-to-face evaluation?
Will a subunit converting to an independent HHA
automatically be ``recognized'' as an independent parent HHA without
any further application or formal conversion process? As a part of that
recognition, will the subunits converting be permitted to maintain
their current CMS certification numbers (``CCN'') so as not to
interrupt treatment, billing and reimbursement for current patients?
Will subunits undergoing the conversion process to
branches be treated as new enrollees?
Will subunits undergoing the conversion process be
required to submit new CMS Form 855A applications?
Will subunits undergoing the conversion process be subject
to survey as a ``new'' HHA?
Will subunits undergoing conversion be required to
discharge current patients and readmit them to the parent HHA or an
alternative HHA provider during the conversion process?
Will billing and claims processing for subunits undergoing
conversion to branch offices be interrupted, and how?
How will subunits being converted to branch offices be
added to their parent HHAs' CCNs?
If an 855A is required for a subunit being converted, is
there a way to streamline the process for approval if the subunit has a
positive compliance record?
How will subunits undergoing the conversion process to
become a branch be held accountable for data transmission, billing, and
compliance during the transition process?
Response: HHAs with subunits will need to work through a wide
variety of questions and concerns. As the commenters indicated,
guidance related to converting a branch to a subunit is set forth in
CMS manuals in section 2182.3 of the State Operations Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c02.pdf). Similarly, we believe that the logistics of converting
existing subunits to branches or independent HHAs is also more
appropriately addressed in CMS manuals than in this regulation.
Following publication of this final rule, we intend to issue a Survey
and Certification letter to the states that will explain the change in
terminology and revise the guidance to reflect the new terminology.
Additionally, we will revise sections of Chapter 2 of the State
Operations Manual that address branches and subunits to reflect the
changes finalized in this rule.
Comment: Many commenters suggested that, in order to smooth the
process of converting subunits to branches or independent HHAs, CMS
should reprioritize approval of new branches and new HHAs from a tier 4
priority to a tier 1 priority in the State Survey Agencies and CMS
Regional Offices.
Response: Subunits are already the equivalent of stand-alone HHAs
and will be able to continue functioning as such, relieving the need to
change to branches. Since there would be no threat to an HHA's ability
to function and serve its patients, we do not agree that it would be
appropriate for CMS to allocate survey resources to those HHAs that
desire to, but do not need to, convert a subunit to a branch. Thus, the
current process and priority levels will remain the same.
Comment: Numerous commenters stated that the final regulation
should provide ample time for HHAs to convert a subunit to either a
parent or a branch. Commenters stared that HHAs converting from
subunits to independent parent HHAs may need to put into place a new
governing body and/or appoint a new administrator, meaning that HHAs
may need time to recruit, hire, train and integrate these individuals.
Commenters also stated

[[Page 4552]]

that time may be needed for subunits to file new or amended state
licensure applications and complete the processes necessary to obtain
new or amended licenses. Lastly, commenters also stated that existing
subunits in some states would have to seek and obtain permission from
their respective state certificate of need agencies to convert to an
independent parent HHA before they could even apply for the necessary
state license. For these reasons, commenters requested a transition
period of 6 to 12 months to ensure that HHAs have adequate time and
preparation to come into compliance with the new parent-branch
requirements that eliminate the use of subunits.
Response: All requirements set forth in this rule, including the
removal of the subunit organizational structure, are effective July 13,
2017. We believe that this will provide HHAs with adequate time to make
any adjustments for a subunit to begin operations as a stand-alone HHA.
Comment: One commenter suggested that the regulations related to
HHA structure and parent-branch relationships could be streamlined by
eliminating the requirement for bordering states to have reciprocal
agreements in place in order to cross state borders. The commenter
stated that this would negate the necessity of the separate provider
number and resulting duplicative and unnecessary administrative costs.
Agencies' offices in bordering states could then function under the
revised branch definition, as proposed.
Response: This suggestion regarding reciprocal agreements between
State Survey Agencies is related to the survey process, and is not
within the scope of this rule, which sets forth the health and safety
requirements for HHAs. Therefore, we are not addressing it in the rule.
Comment: A commenter requested reassurance that HHAs with existing
subunits may choose to convert the subunit to either a parent or a
branch at the HHA's discretion, subject to state-specific laws and
regulations and the ability of the parent to demonstrate direct support
and administrative control.
Response: The commenter is correct. A subunit may choose to be a
distinct HHA (a parent) or go through the current approval process to
become a branch.
Comment: A commenter expressed concern with the proposal that an
HHA may not contract with an entity that has been denied Medicare or
Medicaid enrollment; been excluded or terminated from any federal
health care program or Medicaid; had its Medicare or Medicaid billing
privileges revoked; or been debarred from participating in any
government program. The commenter asked whether the entity's
attestation that it meets these conditions as part of the written
agreement would be sufficient to demonstrate compliance with this
requirement. The commenter stated that it would be very difficult for
an HHA to obtain this information directly.
Response: We appreciate the opportunity to clarify this
requirement. Enforcement of these provisions will vary based on the
specific provision to be verified. In order to identify whether or not
an entity has been denied enrollment or had its billing privileges
revoked, we agree that written and signed self-certification is the
most appropriate method to assure compliance because this is not
publicly available information that HHAs can check on their own.
However, we expect that HHAs will routinely check the List of Excluded
Individuals and Entities (https://oig.hhs.gov/exclusions/). HHAs should
also check the Special Advisory Bulletin (https://oig.hhs.gov/exclusions/advisories.asp). In addition, in order to check whether or
not an entity has been debarred, in accordance with the debarment
regulations at 2 CFR 180.300, an HHA may check the System for Award
Management (https://www.sam.gov/portal/SAM/#content) or obtain self-
certification from the entity. HHAs are responsible for assuring a
contracted entity's continued good standing, and would be expected to
establish policies and procedures for doing so.
Comment: A small number of commenters suggested that the
regulations should permit those individuals who are employed by a
``Professional Employer Organization'' (PEO) to be considered a direct
employee for purposes of the proposed requirement that at least one HHA
service must be provided directly.
Response: It is our longstanding policy to establish a ``direct''
relationship between an employer and employee through the issuance of a
W-2 by an employer to an employee without intermediaries. We did not
propose to revise our longstanding policy and the commenters did not
provide any evidence to demonstrate that the use of PEOs would improve
patient health and safety. Therefore, we are maintaining current CMS
policy that providing a service ``directly'' means providing a service
by employees who are issued a W-2 by the HHA.
Comment: A commenter suggested that the regulation should be
clarified so that a service would be considered to be provided
``directly'' in situations when that service is temporarily provided by
supplementary contracted staff. For example, an HHA may employ a large
number of nurses to provide nursing services directly, but use
contracted supplement nurses in situations such as a medical leave of
absence of an employed nurse or to fill an employed nurse position
while the HHA hires a new nurse. The commenter stated that having one
or two temporarily contracted staff should not preclude the HHA from
designating that service as being provide directly by the HHA.
Response: In order to assure compliance at all times with the
requirement of 484.105(f), which states that a HHA ``must provide at
least one of the services described in this subsection directly,'' an
HHA may not use contracted individuals to provide its chosen service
directly.
Comment: A commenter suggested that the services of mental health
professionals (Social Workers, Psychologists, Counselors, and
Therapists) should be part of home health services.
Response: Medical social services are already part of the HHA
benefit, as set forth in the Act. However, mental health services
beyond those provided as medical social work services are not within
the scope of HHA services as set forth in section 1861(m)(3) of the
Act. For this reason, it would not be appropriate to include the
services of other mental health professionals in this rule.
Comment: A commenter suggested that all regulations related to HHA
financial planning should be removed or replaced by a regulation that
focuses on the sufficiency of the HHA's operating budget to meet its
needs and provide services to the patients in its care.
Response: The financial planning requirements for HHAs are set
forth in section 1861(z) of the Act and these regulations implement
those statutory requirements. Therefore, we are required to retain the
financial planning requirements in this rule.
Clinical Records
Comment: We received many comments on the content of the clinical
record. A few commenters supported the requirement, stating that it
would decrease duplication by no longer requiring certain information
(for example, physician name and drug, treatment and activity orders)
be included in a dedicated part of the clinical record since this
information is also in the plan of care, which is a part

[[Page 4553]]

of the total clinical record. Other commenters requested clarification
on what was meant by the term ``current'' comprehensive assessment. One
commenter questioned the rationale for requiring that the home health
clinical record contain the current assessment, including all of the
assessments from the most recent home health admission. This commenter
went on to say that assessments from prior admissions would have
limited value in providing an accurate picture of a patient without all
other components of the clinical record from that time frame.
Furthermore, ``most recent admissions'' leaves home health agencies in
the position of having to guess at the required time frame and the
number of assessments needed to meet the requirement. The commenter
recommended that CMS remove the requirement to include the assessments
from prior admissions in the current clinical record since these
assessments can be retrieved and viewed in the context of the total
previous record for 5 years, in accord with record retention
requirements.
Response: The current assessment would be the assessment that was
completed with the most recent date. We did not propose, nor are we
finalizing, that the record must include assessments from prior
admissions. The patient's record is meant to provide a full history of
that patient's care and status while he or she is under the care of the
HHA. Therefore, it must contain all assessments ever related to the
patient's current admission. HHAs may choose to keep the most current/
recent assessment in a different part of the record to differentiate it
from older, out of date assessments, if that would improve clarity for
users of the clinical record.
Comment: One commenter urged CMS to require listing the inclusion
of contact information for caregivers, not just the patient and any
representative, in the patient's clinical record (Sec. 484.110(a)).
The commenter goes on to say that while the comprehensive assessment
identifies caregivers and itself is part of the clinical record,
specifically including contact information for the caregivers is
appropriate in light of the various responsibilities specified for HHAs
with respect to a patient's caregivers throughout the CoPs.
Response: We agree that, in addition to the patient representative
contact information (whether legal or patient-selected), it is
important to include contact information for the primary caregiver(s)
as well. We believe this would be helpful to the HHA staff as they
coordinate and deliver care. Therefore, we amended the language at
Sec. 484.110(a)(4) by adding this requirement to the final rule.
Comment: One commenter expressed concern that it may be difficult
for some organizations to obtain and keep contact information for the
patient's primary care practitioner who will be responsible for
providing the patient's care after discharge. The commenter also states
that the requirement is very broad in scope, and in many cases the
practitioner who will care for the patient after discharge may work
within a practice in which one specific provider may not be identified
for the patient. In addition, the practitioner who will care for the
patient after discharge may not be the same as the physician(s) writing
home health orders for the patient. The commenter continues on to say
that this is often problematic for organizations to determine which
practitioner will be providing care for the patient after they have
completed their home health visits.
Response: We understand the commenter's concerns with obtaining
contact information for the patient's follow-up care practitioner.
However, we strongly believe this information benefits the patient by
supporting continuity and transition of care between the HHA and the
primary care or other practitioner. The practitioner(s) who will be
responsible for providing post-discharge care need to be identified in
the record so that HHAs know with whom to communicate regarding
discharge planning, as required in Sec. 484.60(c). We understand that
the patient's practitioner(s) may be different than the physician(s)
issuing orders for the HHA plan of care, which is why we strongly
believe that requiring separate identification of the practitioner in
the patient's clinical record is so important. Lastly, we understand it
may not be possible to identify the name and contact information for a
specific practitioner where the practice as a whole furnishes care to
the patient. In such cases it is acceptable for the HHA to include the
contact information of the health care practice.
Comment: We received many comments regarding clinical records and
the proposed discharge summary requirements. Some commenters supported
the transfer/discharge requirement, with one commenter stating that
they wanted to reinforce their belief that CMS was correct in assuming
that most agencies do develop and send a discharge summary to the
physician at the time of discharge. Many commenters stated that the 7
day and 2 day proposed timeframes to send the discharge or transfer
summary was not enough time. Commenters stated that transfers and
discharges could occur on weekends or holidays when staffing,
specifically administrative staffing, is lower. Commenters suggested
numerous alternative timeframes, as follows:
2 business (rather than calendar) days for transfer
summaries.
7 business days for both discharge and transfer summaries.
Transfer summaries on the day of transfer and discharge
summaries in 2 calendar days.
5 business days for transfer summaries and 10 business
days for discharge summaries.
7 to 14 business days for discharge summaries
No timeframes for any summaries
Another commenter requested that if the HHA is not able to meet the
timeframe requirements, CMS should permit the HHA to document the
reason(s) in the medical record.
Response: We appreciate the wide array of comments. While most
commenters believed that transfer and discharge summaries are
important, the time frames suggested varied greatly. We believe both
transfer and discharge summaries are important for care continuity and
transitions. Transfer summaries prepared and sent on the day of
transfer, and discharge summaries prepared and sent in 2 calendar days
after discharge are ideal, and we strongly encourage all HHAs to meet
these timeframes. However, we understand that this may not be feasible
in all transfer and discharge situations. The CoP requirements are
meant to establish maximum timeframes. Thus, we believe that 2 business
days for a transfer summary and 5 business days for discharge summary
are appropriate maximum standards, and have amended the regulatory
language at Sec. 484.110(a)(6)(i) and (ii) to reflect these new
timeframes.
Comment: Some commenters stated that HHAs may not know that a
patient was transferred to a facility for several days after that
transfer has occurred, and therefore suggest starting the 2 day clock
when the HHA becomes aware of the transfer. In addition, one commenter
stated that no discharge/transfer summary for urgent/emergent
admissions should be required, because HHAs usually do not know about
these until several days later, and providing discharge/transfer
summary days after the fact is not helpful to the receiving provider.
One commenter suggested that the regulation should not require HHAs to
send discharge or transfer summaries to hospitals; while another
commenter

[[Page 4554]]

requested CMS to consider allowing the HHA to develop their own policy
on how to best communicate patient information at the time of transfer
or discharge, which could include a verbal or written report. The
commenter stated that in many cases, it is uncertain who at a hospital
should receive the information. Additionally, the commenter stated
that, generally, the discharge or transfer information would not be
used in the diagnosis or treatment of the hospitalized individual.
Response: We understand the commenters' concerns regarding the
issues surrounding an unplanned transfer to a facility, and agree that
it would be difficult for the HHA to comply with the requirements if it
was not aware that the transfer had occurred. Therefore, we have
amended the regulatory requirement at Sec. 484.110(a)(6)(iii) to
require that the HHA sends a completed transfer summary within 2
business days of becoming aware of an unplanned transfer, only if the
patient is still receiving care in the receiving health care facility
at the time when the HHA becomes aware of the unplanned transfer. We
believe that this revision strikes an appropriate balance between
sharing information, when such sharing has the potential to be helpful
because the patient is still under the care of the inpatient provider,
and conserving HHA resources when the patient has been admitted and
discharged from the inpatient care provider before the HHA is even
aware of the situation. In the future, as the use of interoperable
health records becomes widespread in the HHA industry, we may consider
a shorter timeframe for sending a transfer summary in order to make the
information exchange more timely and relevant to patient care.
Comment: One commenter suggested that transfers without an agency
discharge, where the agency will be resuming care, should require that
a transfer summary be provided only if a transfer summary was requested
by the receiving facility. In addition, others stated that a transfer
summary would only be needed if a patient was being discharged with no
plan to return to the HHA. Another commenter suggested that an agency
should be relieved of this requirement if the patient was admitted to
home health from a facility and returned to that same facility.
Response: We appreciate these comments. While we understand that
patients may be discharged for a period of time and then return to the
HHA, we strongly believe that a transfer summary should be proactively
sent, and that this information benefits the patient by supporting
continuity and transition of care between the HHA and the receiving
facility or practitioner. Therefore, no additional changes have been
made to the transfer summary requirements at Sec. 484.110(a)(6)(iii).
Comment: One commenter stated that CMS may want to consider
including the requirement to send the discharge or transfer summary in
Sec. 484.60(e), Discharge or transfer, in addition to or instead of
Sec. 484.110(a), Contents of the clinical record. This requirement is
more aligned with care coordination than clinical records, and moving
its placement could make it easier to find for HHA staff working on
discharge policies.
Response: While this requirement could also be grouped with those
related to the content of the discharge or transfer plan, it is equally
appropriate to include this requirement in the clinical record section
because it addresses timeframes for distributing items that are
maintained within the clinical record. In developing their own policies
and procedures surrounding the discharge or transfer process, HHAs are
free to gather information from all sections of the CoPs that are
appropriate to inform the development of relevant HHA policies and
procedures.
Comment: One commenter recommended that the regulation require the
HHA to send a copy of the discharge or transfer summary to the patient,
representative (if any) and the caregiver.
Response: Section 484.60(c)(3)(ii) requires that changes in the
discharge plan must be communicated to the patient, representative and
caregiver. We believe that this communication is appropriate and
necessary for the patient, representative and caregivers. However, the
discharge and transfer summary is written for medical professionals and
is not necessarily appropriate for the patient's use. Therefore, we do
not think that it is necessary to require HHAs to provide a copy of the
discharge summary to each patient. Additionally, HHAs are required to
educate patients and caregivers regarding their roles in implementing
the plan of care, so patients and caregivers should already have the
knowledge and skills necessary to meet any ongoing care needs following
cessation of home health services.
Comment: We received a few comments regarding the proposed clinical
record authentication requirements. Some commenters supported the need
to document the actual time of administration of treatments and/or
medication administration, but were unsure as to why each entry into
the record, which is not a time sensitive issue, must be timed. In
addition, one commenter requested that CMS clarify ``timed'' in the
sentence ``dated and timed.'' One commenter also went on to ask if this
requirement would include all records of case conferences, phone calls,
interdisciplinary communications, etc. be timed and dated; and if so,
what would be the supporting reasoning as to the need to time such
communications. An additional commenter also supported this requirement
but noted that these requirements are often part of organizational
policy. This commenter went on to state that some organizations will
have difficulty meeting the requirements due to failure of staff to
date and time their entries and encourages CMS to provide education for
all home care organizations on these requirements.
Response: There seems to be confusion related to what we mean by
the term ``timed.'' To clarify, ``timed'' means the actual time that an
event occurred, which is not necessarily the time when the
documentation was entered into the record. The date and time
requirement applies to all entries in the record. We believe it is
extremely important that the clinical record accurately reflects a
clear account of the patient's entire course of care. The clinical
record should tell a linear story of the course of the patient's care
that is managed and delivered by the HHA. Without timing entries, there
is the risk for a disjointed record and a possibility for the
occurrence of avoidable medical errors.
Comment: We received a few comments on authentication. One
commenter requested that the regulations be more specific about what is
required for electronic signature, and require electronic audit trails
which show if any changes were made in a patient's electronic health
record, exactly what changes were made, who made those changes, and
when those changes were made in all electronic health records. The
commenter stated that HHAs experience problems with vendors when HHA
surveys identify documentation problems. One commenter recommended that
language relating to ``signature and title'' be replaced with the
broader requirement for ``authentication'' without specifying how that
authentication would be accomplished. Lastly, one commenter recommended
that CMS allow providers that maintain clinical records electronically
to scan the ``signature'' documents and then destroy the paper copies.

[[Page 4555]]

Response: We appreciate the comments received on the subject of
record authentication. ``Electronic signatures'' may mimic paper
signatures, complete with a signature and a title (occupation), or may
be a secured computer entry by an identifier that is unique to the
individual creating the entry. These requirements, particularly those
for a ``signature and title'' are standard practice, and we see no
reason to deviate from them at this time. While we understand that HHAs
may desire to destroy paper copies of signature documents in order to
reduce physical paper storage space, we believe that maintaining the
original, signed paper documents is essential for purposes of
authentication of the documents. Furthermore, while we agree that
electronic audit trails may be a useful tool for some HHAs, we do not
believe that they should be incorporated into the regulations as a
minimum requirement for all HHAs because there is more than one way for
an HHA to achieve the goals accomplished by electronic audit trails.
Furthermore, electronic audit trails would not apply to those HHAs that
choose to use paper records. HHAs bear ultimate responsibility for
continuous compliance with the requirements of these regulations, and
are expected to manage all contracts, including those with software
vendors, to assure such compliance. We urge HHAs to engage in due
diligence to ensure that their vendors are providing them with EHR
technology solutions that support patient health.
Comment: CMS received a few comments on record retention. One
commenter recommended that retention of records mirror the timeframes
in other federal law or regulation. For example, 5 years does not
correlate with requirements for HIPAA or the look back periods for
recovery audit contractors or zone program integrity contractors. While
another commenter supported the 5 year time frame; stating it
simplifies the timeframe during which the patient's records are kept (5
years from discharge as opposed to from filing of cost report) and for
some states record retention regulations are stricter, requiring
records be held form 6 years. Therefore this standard would not impose
burdens on agencies in the state.
Response: We believe that retaining records for a period of 5 years
is sufficient for health and safety purposes. We acknowledge that other
rules may exist that contain different record retention or compliance
documentation timeframes. HHAs need to develop their own agency-
specific policies and procedures to assure that records are retained in
accordance with the law, regulation, or policy that requires the
longest retention period, which may exceed the 5 year period
established here.
Comment: We received a few comments on the availability of clinical
records. One commenter supports the standard, stating it facilitates
access to records by patients, authorized individuals and entities to
ensure transparency and continuity of care. Another commenter requested
clarification on the timeframe for making records available, stating
that, in cases where individuals are onsite awaiting information, HHAs
should be allowed sufficient time to assemble records. In many HHAs,
not all materials are electronic, including signed verbal orders, files
from hospitals, and other content. HHAs may need several hours to
compile the most up-to-date records. For other purposes, the commenter
recommended that HHAs be allowed a minimum of 4 business days to make
records available. Another commenter stated that this proposed
condition will encourage more requests for copies of medical records
which will increase costs. The commenters internal analysis indicates
that as much as $230,000 annually may be incurred on HHAs should there
be a large increase in medical record requests and urges CMS to
acknowledge the increase in costs of this requirement.
Response: We believe that all patients should have the right to
receive information contained in the clinical record, including the
plan of care, free of charge. We agree with the commenter that
suggested HHAs be allowed a maximum of 4 business days to make records
available. Additionally we understand that the HHA may have another
scheduled visit with the patient before the 4-day mark and that it
would be advantageous for the HHA to deliver the record at that next
scheduled visit. Likewise, if a patient requests to have the plan of
care emailed, the HHA would have a maximum of 4 business days to
comply. Therefore, we are finalizing this requirement to state that
``[a] patient's clinical record (whether hard copy or electronic form)
must be made available to a patient, free of charge, upon request at
the next home visit, or within 4 business days (whichever comes
first).'' HHAs may also be governed by state laws and regulations that
pertain to this issue, and are expected to comply with such laws and
regulations to the extent that they provide greater rights of patient
access than HIPAA. We also understand and agree that it may take
several hours to assemble a complete clinical record to be reviewed
onsite, such as for state surveyor review. We do not think that this
regulation is going to dramatically increase record requests. For
additional information and guidance on the HIPAA requirements for
patient access with which HHA's must also comply, please see guidance
issued earlier this year from the OCR available at http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html.
Comment: We received several comments related to electronic health
records (EHRs). A few commenters stated that incentives should be given
to offset the costs and detailed training guidelines should be offered
to HHAs who make the switch. One commenter offered support for EHRs,
stating that they encourage the exchange of health information across
all providers to improve the quality of care and care transitions.
According to commenters, EHRs have been proven to reduce medical error
rates and help improve the coordination of patient care. Therefore,
according to commenters, assisting HHAs in making the leap to EHRs
would be beneficial to improving the quality of patient care.
Response: We appreciate the commenter feedback related to EHRs. The
Department of Health and Human Services is committed to accelerating
health information exchange through the use of EHRs and other types of
health information technology (health IT) 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 health IT and health information exchange services
through Medicare and Medicaid payment policies; (2) adoption of common
standards and certification requirements for interoperable health IT;
(3) support for privacy and security of patient information across all
health information exchange-focused initiatives; and (4) governance of
health information networks. These initiatives are designed to improve
care delivery and coordination across the entire care continuum and
encourage the electronic exchange of health information 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 such programs. However, providing additional
incentives to any provider, including HHAs, is beyond the scope of this
rule and subject to the limitations of statutory authority.
Comment: One commenter believes that HIE, in theory, is an
outstanding idea. The efforts nationwide, however, are scattered and of
varying success. In

[[Page 4556]]

the absence of ACA funding, some are failing. The commenter stated that
he does not believe that use of an HIE should be addressed in the CoPs.
With regard to interoperability, the commenter recommended
consideration of the most recent ONC statement on interoperability, and
stated that at this time full interoperability is too far in the future
to make HIE an element of CoPs. Another commenter stated that a
certification program, required or voluntary, cannot be successful
without industry and provider commitment to the necessity of such a
program and without participation requirements applicable to the
provider community. The commenter also expressed concern that voluntary
or required certification without the implementation of Meaningful Use
Stage 3 will neither substantially improve the alignment of existing
federal and state programs nor appropriately balance the required costs
and benefits due to the current low adoption rates of Meaningful Use
Stage 2 requirements by hospitals and other eligible providers.
Response: We agree that this is not the appropriate time to
require, in the CoPs, the use of HIEs or compliance with any stage of
the Meaningful Use criteria. We will continue to monitor the voluntary
use of certified record systems and HIEs, and would use the notice and
comment rulemaking process to promulgate any future HHA regulations
related to these issues.
Comment: One commenter stated that it was important to point out
that as a result of the growing discussion related to the use of
massive collections of data, an integrated information database that is
aimed at improving quality standards in HHAs and aimed at a more
comprehensive approach towards current and long term health care
specifically designed for each individual patient could be a wonderful
tool if used correctly. The commenter cautioned, however, that the
amassing of data and the technology that is used to analyze it may be
vulnerable to exploitation.
Response: We agree that it is incumbent upon HHAs to appropriately
secure data, and the systems used to collect and analyze it, against
inappropriate access and use. Section 484.110(d), Protection of
records, requires that HHAs must be in compliance with the HIPAA
Privacy and Security rules regarding protected health information set
out at 45 CFR parts 160 and 164. We believe that this requirement
establishes an appropriate expectation of security in the maintenance
of patient data, and the systems used to collect and analyze it. In
addition to the steps taken by HHAs to assure the confidentiality of
data that they collect, CMS takes all appropriate steps to assure the
security of all data that is submitted to CMS by HHAs.
Personnel Qualifications
Comment: We received many supportive comments regarding personnel
requirements. One commenter supported the retention of the requirement
that ``social work assistants'' be supervised by a qualified social
worker. One organization strongly supports the proposal to retain
personnel qualification requirements, including those for occupational
therapy. This commenter stated that keeping the qualification
requirements intact protects the public health, safety, and welfare of
the patients served by occupational therapy practitioners and ensures
that services are performed by trained and qualified providers.
Response: We appreciate the support of the commenters, and agree
that establishing minimum personnel qualifications is an essential part
of assuring the safety and quality of HHA care.
Comment: We received many comments on the personnel qualification
of the administrator. A few commenters requested that CMS grandfather
in the current administrators, with one commenter stating that there
should be an exception policy in place that acknowledges years of
experience in the Medicare certified home health field as an
appropriate qualification for a home health administrator. One
commenter stated that they applaud expanding the standard for
eligibility for the administrator. The commenter added that they
supported the role of administrator being provided by persons with
skill sets that do not require medical or nursing degrees. A few
commenters requested that CMS not require a degree and experience,
stating that experience all on its own is good enough and requiring
both is too burdensome. One commenter stated that an undergraduate
degree and 1 year of experience does not seem adequate to fulfill the
role of administrator, which requires knowledge in many areas. The
commenter suggested that a graduate degree or specialized clinical
certification and additional years of experience in management would be
appropriate. Another commenter advised that CMS not have any
qualification requirements.
Response: It was not our intent to disqualify any currently
employed administrator from continuing to perform his or her job duties
with his or her current employer. Therefore, we agree that
administrators who do not meet these qualifications should be allowed
to continue employment in their current position, and we have revised
the regulation at Sec. 484.115(a) to reflect this policy. In light of
the various suggestions from the public regarding the appropriate
qualifications for those administrators that begin working for an HHA
after the effective date of this final rule (July 13, 2017), we have
chosen to finalize the originally proposed requirement. An
administrator who begins working for an HHA after the effective date of
this final rule, even if he or she was previously employed as an
administrator for a different HHA, is required to be a licensed
physician, a registered nurse, or hold an undergraduate degree. A
registered nurse would include a Nurse Practitioner or other advance
practice nurse. Additionally, an administrator who begins working for
an HHA after the effective date of this final rule is required to have
experience in health service administration, with at least 1 year of
supervisory or administrative experience in home health care or a
related health care program. We believe that this combination of
education and experience requirements strikes an appropriate balance
between those commenters who sought to require that an administrator
must possess a graduate degree and those who sought to remove all
personnel requirements for an administrator. Furthermore, we believe
that adding these personnel requirements for all future administrators
will serve as a disincentive to the creation of HHAs that are operated
with fraudulent intent, as many of these entities are opened by
individuals who would not meet these minimum qualifications. Such HHAs
pose a significant threat to the health and safety of Medicare
beneficiaries in need of HHA services. The personnel requirements set
forth in this rule are the minimum requirements. HHA governing bodies
may establish more stringent requirements that meet the needs of their
organizations.
Comment: We received one comment on the personnel requirements for
occupational therapists and one comment on occupational therapy
assistants. The commenter stated that the qualifications for
occupational therapists are almost identical to current regulation.
However, the current regulations allow therapists educated abroad to
meet part of the necessary criteria by successfully completing a
program that is substantially equivalent to occupational therapist
entry-level

[[Page 4557]]

education in the U.S. offered by one of four categories of
organizations. In the proposed rule, the therapist must have
successfully completed a program that is substantially equivalent to
occupational therapist assistant entry-level education in the U.S. by
one of the four categories of organizations. The commenter questioned
why the word ``assistant'' appears here, since there is a separate set
of qualifications for occupational therapy assistants. The commenter
who asked about occupational therapy assistants is requesting
clarification stating that the qualifications outlined in the proposed
rule for an occupational therapy assistant are almost exactly the same
as those in current regulation. However, the proposed rule states that
an occupational therapy assistant is a person who ``[a]fter January 1,
2010, meets the requirements in paragraph (b)(6)(i) of this section.''
There is no paragraph (b)(6)(i) in the proposed rule text.
Response: Our intent was to maintain all of the current
qualification options for occupational therapists and occupational
therapy assistants, without change. We have revised the regulatory
requirements to correct these technical errors.
Comment: We received a few comments on the personnel qualifications
for physical therapists and physical therapy assistants. For physical
therapists, one commenter requests clarification, stating that in the
proposed rule, physical therapists must be licensed (if applicable) and
must meet one of several additional categories of qualifications. In
current regulations, the first category requires physical therapists to
have successfully completed a physical therapist education program and
passed an examination for physical therapists approved by the state. In
the proposed rule, the word ``and'' is dropped, and the text is
renumbered in a way that could imply that either education or passage
of an exam is acceptable. An additional commenter requests
clarification as to whether CMS intended to propose this change,
stating that under current standards, the fifth category requires a
physical therapist to have been admitted to membership by the American
Physical Therapy Association (APTA); or admitted to registration by the
American Registry of Physical Therapists; or have graduated from a
physical therapy curriculum in a 4-year college or university approved
by a state department of education. In the proposed rule, the fifth
option includes the above mentioned membership, registration and
graduation from a physical therapy curriculum. We received one comment
on physical therapy assistants requesting that CMS consider clarifying
and revising the qualifications for physical therapy assistants. This
commenter stated that under the proposed rule, a physical therapy
assistant is a person licensed, registered or certified as a physical
therapy assistant, if applicable, by the state in which the assistant
is practicing, unless licensure does not apply. In addition, the
assistant must meet one of two other categories of criteria. In the
first category, the assistant must meet the same specified education as
listed in current regulations. In the second category, the assistant
must have passed a national exam for physical therapist assistants
before 2010, and he or she must meet one of the following criteria:
Is licensed, or otherwise regulated in the state in which
practicing; or
In states where licensure or other regulations do not
apply, graduated before 2010 from a 2-year college-level program
approved by APTA and after January 1, 2010, meets the requirements of
paragraph (b)(8) of this section.
The commenter stated that it was unclear what was meant by the
reference to (b)(8) of this section, as there was no (b)(8) in the
proposed regulations text.
Response: We did not intend to alter the content of the
requirements for physical therapists and physical therapy assistants in
any way. Any appearance of alteration is due to changes in numbering
and/or the unintentional switching of the terms ``and'' and ``or'',
which we have revised accordingly in this final rule. We have also made
other technical corrections, as described in this preamble.
Comment: We received several comments that noted the definition of
Physician at 42 CFR 410.20(b) is not consistent with the specialties of
physicians who may certify and establish the plan of care for home
health services in the regulation at 42 CFR 424.22(a)(1)(iii). The
commenter recommended the requirements for a physician should refer to
42 CFR 424.22(a)(1)(iii).
Response: The personnel requirements for a physician refer only to
those physicians who are employed by, or are under arrangement with, an
HHA. These requirements would not apply to hospital and community-based
physicians who are responsible for issuing orders that establish the
home health plan of care, as they would function outside of the purview
of the HHA. The requirements set forth at Sec. 424.22(a)(1)(iii) are
specific Medicare payment requirements for physicians who certify the
eligibility of patients for the Medicare home health benefit. We do not
believe that it would be necessary or appropriate to narrow down the
group of physicians who are eligible for HHA employment to just those
physician types set forth in the payment regulations because HHA
physicians may perform many roles that do not relate to certification
of HHA patients.
Comment: We received a few comments on the personnel qualifications
for social workers. One commenter supported the addition of doctoral
degree as a qualification option. Another commenter stated that
baccalaureate (BSW), master's (MSW), or doctoral degree in social work
is the only sufficient preparation for social work.
Response: We agree that a master's or doctoral degree is an
appropriate qualification, and are finalizing this proposal without
change. HHAs may choose to further restrict those individuals who are
employed as social workers in order to meet their specific needs;
however we do not agree that it is appropriate for these regulations to
impose such a restriction, as it would disqualify many long time social
workers who happen to have degrees in other related fields. Therefore
we are maintaining the current requirement that a degree in a related
field would be considered an appropriate qualification for a social
worker.
Comment: We received one comment on the personnel qualifications
for speech language pathologists. Specifically, this commenter states
that CMS is correct in the assumption that all states now have
licensing requirements for speech-language pathologists (SLPs).
However, the commenter asserted that ASHA certification and completion
of a degree from a Council on Academic Accreditation in Audiology and
Speech-Language Pathology (CAA) approved program remains the standard
and ensures that speech-language pathologists are participating in a
minimum number of continuing education hours. Additionally, not all
U.S. Territories have licensure; therefore, continued use of ASHA
certification is warranted. The commenter recommends that CMS continue
to reference ASHA certification for minimum qualifications and requests
that the revision maintain the ASHA certification.
Response: Section 1861(ll)(4)(A) of the Act, on which the
regulation is based, does not limit SLPs to only those individuals who
meet the ASHA certification standards. Since this

[[Page 4558]]

limitation does not exist in the Act, we do not believe it should exist
in the regulations. Therefore, in order to align the regulatory
requirements with those requirements set forth in the Act, we are not
making the suggested change. States are free to require ASHA
certification as part of their SLP licensure standards.
Comment: We received one comment on the personnel requirements for
the clinical manager. The commenter states that while they support the
creation of the clinical manager position, they advise that CMS
consider the inclusion of specific qualification requirements for the
clinical manager, since there are frequent deficient practices related
to reassessments, referrals, coordination of care and updating plans of
care.
Response: We agree that it is appropriate to establish minimum
personnel requirements for clinical managers. In the October 2014
proposed rule we proposed that a clinical manager be either a licensed
physician or RN (79 FR 61164, 61183). As stated previously, commenters
also suggested a therapist or social worker could fill this role. We
agree that those professionals may also be qualified to fulfill the
duties of the clinical manager. Thus, we are finalizing a requirement
at Sec. 484.115(c), Clinical manager, requiring that a clinical
manager be a licensed physician, physical therapist, speech-language
pathologist, occupational therapist, audiologist, social worker, or a
registered nurse. A registered nurse would include a Nurse Practitioner
or other advance practice nurse.
Comment: We received a few comments related to criminal background
checks. Specially, one commenter stated that background checks should
be done for all staff members, especially those who plan to go to a
patient's home to deliver health care. A few additional commenters
advised that CMS should require reasonable and appropriate standards
for criminal background screenings and that criminal background checks
should be required for all owners, operators, or employees that have
direct patient contact or access to patient records in order to
validate competency according to minimum standards established by the
Secretary.
Response: The National Background Check Program (NBCP), as
established by the Affordable Care Act, aims to create a nationwide
system for conducting comprehensive background checks on applicants for
employment by the LTC facilities and providers. The term ``long-term
care facility or provider'' means the following facilities or
providers: Skilled nursing facility, nursing facility, home health
agency, provider of hospice care, a long-term care hospital, a provider
of personal care services, a provider of adult day care, a residential
care provider that arranges for, or directly provides, long-term care
services, including an assisted living facility, an intermediate care
facility for the intellectually disabled, and any other facility or
provider of long-term care services as the participating state
determines appropriate. Prior to passage of this law and creation of
the NBCP, many states already required background checks for LTC
workers, but state requirements and programs varied. The intent of the
NBCP is to set-up a standard, effective, and economical program to
conduct background checks that also includes fingerprint-based criminal
history checks. The U.S. Department of Health and Human Services,
Centers for Medicare & Medicaid Services (CMS) administers the NBCP.
Since the start of the program in 2010, CMS has awarded nearly $57
million in grant funds to a total of 25 states and U.S. Territories to
design, implement, and operate background check programs that meet CMS
criteria. We believe that this comprehensive program that fosters
consistency in implementation is a preferable way to improve the volume
and scope of background checks that are conducted for HHA employees and
contractors.
Summary of Care
Comment: We received many comments on the removal of the 60-day
summary of care requirement (79 FR 61166). A few commenters supported
the elimination of the summary of care notification every 60 days. One
commenter stated that their physicians did not see true value in having
another document to review, but instead valued the verbal communication
with them at pertinent times related to the care and treatment of their
patient(s). Other commenters requested clarification as to whether it
would be expected that the information typically contained in the
summary of care notice would be provided to the physician by some other
means or format. However, other commenters did not support the removal
of the summary of care every 60 days. These commenters stated that,
although immediate communication of timely events is undeniably
important, it was not equivalent to summarizing the patient's status to
the physician at the time of recertifying the plan of care because
physicians do not always remember the relevant recent issues concerning
a particular patient when asked to review and recertify a plan of care.
Another commenter stated that CMS did not offer any other support or
justification for this change. A commenter also stated that the Impact
Analysis was unclear, specifically, the calculation that this
requirement ``imposes a burden of 3 minutes per patient'' (it was
unclear if CMS meant 3 minutes every 60 days or cumulatively for a
year), and that removing the provision would amount to a savings of
nearly $17 million annually.
Response: Section 484.60(c)(1) requires that the HHA must promptly
alert the physician(s) issuing orders for the HHA plan of care to any
changes in the patient's condition or needs that suggest that outcomes
were not being achieved and/or that the plan of care should be altered;
the requirements at Sec. 484.60(c)(3) requires that revisions to the
plan of care due to a change in health status or a change in discharge
plans be communicated to the physician issuing orders for the
condition(s) that led to the initiation of home health care who was
responsible for the HHA plan of care; and Sec. 484.75(b)(7) requires
that every skilled professional be responsible for communicating with
the physician(s) issuing orders for the HHA plan of care. All three of
these requirements in this final rule clearly establish the expectation
that HHAs would apprise physicians of the information necessary to make
appropriate decisions regarding the content of the plan of care at all
times. We do not believe that a 60-day summary of care is a necessary
regulatory requirement on top of the requirements referenced above. The
burden imposed by the summary of care was originally estimated in the
currently-approved PRA package (OMB control number 0938-0365),
originally published in the Federal Register on July 12, 2013 (78 FR
41931).\1\ The burden estimate assumed a burden of 3 minutes per
patient to develop the summary of care, and assumed that each patient
would only be in HHA care long enough for a single 60-day summary of
care to be prepared. We did not receive any public comments on this
estimate at that time, and believe that they continue to be appropriate
to use in this rule for purposes of estimating potential savings to
HHAs. Savings to individual HHAs may be greater or lesser, depending on
the HHA's average length of stay and technical capabilities to automate
the production and distribution of the summary of care.
---------------------------------------------------------------------------

\1\ This collection will be discontinued when a new collection
is approved which will better align the PRA package with new
regulations.

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

[[Page 4559]]

Miscellaneous
Comment: We received a few comments related to home health agency
surveys. One commenter stated that home health agencies should go
through a health accreditation every year based on how their patients
receive care. Other commenters strongly urge CMS to ensure that the
interpretive guidelines provided to surveyors are developed in
collaboration with stakeholders across the industry, either through
direct participation in their development or by providing an
opportunity for stakeholders to comment on such guidelines before they
are used for enforcement purposes. Other commenters encouraged CMS to
share all such interpretive guidelines and surveyor training materials
with HHAs prior to the start of enforcement.
Response: We appreciate the comments on this subject. However, the
survey schedule, survey guidelines, and surveyor training materials are
not within the scope of this rule.
Comment: One commenter asked if patients can receive care at their
home if they are unable to go to a hospital. In addition, the commenter
requested clarification on the kind of benefits patients can receive.
Response: The services covered under the Medicare home health
benefit are set forth in section 1861(m) of the Act, as implemented in
regulation at 42 CFR 409 subpart E. Medicaid and private insurers
establish their own requirements for services, and we encourage the
public to contact the relevant programs for any information that may be
needed. HHA services are not meant to be a substitute for acute care
providers, such as hospitals, in urgent and emergent situations.
Rather, HHAs are expected to deliver part-time or intermittent skilled
care to homebound patients who would otherwise receive care in an
outpatient setting such as a physician office or physical therapy
office, but who are confined to the home.
Comment: A few commenters suggested ways CMS could improve patient
engagement. One commenter suggested that providing Medicare
beneficiaries with materials similar to the annual update to Medicare &
You that offer more details on the home health benefit and its
requirements would be a place to begin. The commenter also suggested
that a YouTube segment explaining the benefit would help beneficiaries,
their families, and other caregivers. A few commenters stated that it
would also help to hear from home health agency patients and their
families to gather information about the quality of service they were
observing, the necessity of certain procedures, and how they thought
the quality of care was meeting the standards set out in the proposed
rule.
Response: We appreciate these suggestions for additional Medicare
outreach options. However, Medicare outreach to beneficiaries is beyond
the scope of this rule. We will retain these suggestions for future
consideration. We agree that a patient care survey is a valuable tool
for quality of care purposes, and implemented the Home Health Consumer
Assessment of Healthcare Providers and Systems survey in October 2009
(https://homehealthcahps.org/).
Comment: We received many comments on referrals. One commenter
suggested that CMS should educate other providers about the value of
home health care. One commenter urged CMS to clarify, in regulation,
that care referrals to HHAs by emergency departments and other care
settings are appropriate. The commenters also suggested that we publish
guidance on appropriate care coordination pathways that would encourage
referrals to HHAs, making them more likely and possible. Another
commenter encouraged CMS to help HHAs educate emergency departments and
other providers to make more frequent and appropriate use of home
health care for a growing volume of beneficiaries with complex health
conditions. Lastly, one commenter recommended that CMS consider
updating the number of paid medical consultants, medical directors, and
physicians who are permitted to refer patients to home health services.
Response: We appreciate these suggestions for referral source
outreach. However, this topic is beyond the scope of this rule. We will
retain these suggestions for future consideration.
Comment: We received multiple comments related to HHA payment
policy issues. Some commenters stated the CMS should increase Medicare/
Medicaid rates for home health services. Another commenter suggested
that CMS should grant greater flexibility in the coverage and
reimbursement of home monitoring for oral anticoagulation therapy,
including CMS coverage for home visits by nurses to patients who find
it difficult to do their own home monitoring or travel to get tested.
One commenter requested that CMS provide funding to HHAs so that they
can develop the computer and related systems needed to share data with
physicians, hospitals and other providers.
Response: We appreciate these suggestions related to Medicare home
health coverage policy and Medicare payment rates. Medicare home health
coverage policy and payment rates are addressed in separate annual
rulemaking, and comments related to this topic can be submitted during
that process. This topic is beyond the scope of this rule therefore, we
are not addressing these suggestions at this time.
Comment: Numerous commenters made suggestions for ways to revise
Medicare home health coverage policy. One commenter requested that CMS
consider permitting non-physician practitioners to perform face-to-face
encounters and to sign a patient's plan of care, to the extent
permitted by the licensing authority in the state in which the
practitioner is licensed. Another organization urged CMS to re-examine
the Medicare homebound requirement for Medicare home health services
eligibility. One commenter shared that the home health industry
advocates have long argued that case or care management is a natural
activity for home health agencies, particularly for elderly individuals
with multiple co-morbidities. However, in order for agencies to be
successful care managers, the focus of the Medicare home health benefit
must shift from exclusively short-term, skilled, post-acute
intervention for the homebound patient to include a chronic care
management and oversight function for patients who may not need skilled
care or be homebound at any given point in time. Additionally, one
commenter stated the inclusion of maintenance therapy guidelines is
greatly needed, and that they agree with the new Medicare Benefit
Policy Manual update that the maintenance of the patient's current
condition and prevention or slowing of further deterioration of the
patient's condition may both warrant the use of skilled care provided
under the Medicare home health benefit. Another commenter suggested
that the social determinants of health should be considered as relevant
variables in the prospective payment system.
Response: We appreciate these suggestions related to Medicare home
health coverage policy. Medicare home health coverage policy is
addressed in separate annual rulemaking, and comments related to this
topic can be submitted during that process. As this topic is beyond the
scope of this rule, we are not addressing these suggestions at this
time.
Comment: We received a few comments related to OASIS. Commenters
urged CMS to update the OASIS instrument to:

[[Page 4560]]

Allow HHAs to indicate when referrals come from EDs and
other health care providers and settings; and
Reflect the social determinants of health.
Response: We appreciate these suggestions related to the content of
the OASIS; however, this topic is beyond the scope of this rule,
therefore we are not addressing these suggestions at this time. We will
retain these suggestions for future consideration.
Comment: A commenter stated that under the Patient Protection and
Affordable Care Act, CMS was required specifically to assess and
document the needs of vulnerable individuals accessing home health
services, and that this should be implemented in the CoPs.
Response: Section 3131(d) of the Affordable Care Act directed the
Secretary to conduct a study on HHA costs involved with providing
ongoing access to care to low-income Medicare beneficiaries or
beneficiaries in medically underserved areas, and in treating
beneficiaries with high levels of severity of illness. A Report to
Congress on this home health study was released at the end of 2014, and
is available to view at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/HH-Report-to-Congress.pdf. We
awarded a follow-on contract to Abt Associates to further explore
possible payment methodology changes as a result of the home health
study. The work is ongoing at this time.
Comment: A commenter expressed confusion with the ``reimbursement
rates'' described in the Collection of Information and Regulatory
Impact Analysis sections. The commenter stated that ``there seems to be
a discrepancy with how services will be reimbursed. According to the
2014-2015 outlook, the hourly rate for physicians, nurses, clinical
managers and administrators is $180, $63, $85, and $98; respectively.
There are asterisks near job titles and hourly rates performed by
nurses. For example, the clinical manager and administrator roles have
asterisks. Clarification is needed regarding the reimbursement rate for
other health care providers, including physicians, performing these
administrative roles.''
Response: The impact analysis does not set forth reimbursement
rates for any HHA services. Rather, as stated in the title of Table 1,
``Assumptions and estimates used throughout the information collection
and impact analysis section'', the impact analysis presents a set of
assumptions regarding how much a typical HHA pays in terms of the
salary, benefits, and overhead associated with a single hour of
employment for a given employee class. What an HHA chooses to pay an
individual fulfilling an administrative role is entirely up to the
discretion of the HHA. For purposes of our analysis, we assumed that a
typical HHA would pay a typical administrator $98 per hour (including
salary, benefits, and overhead). A given HHA may pay more or less than
this amount.
Comment: We received a few comments related to CMS data collection
and one comment related to emergency preparedness. Specifically, one
commenter encouraged CMS to consider collecting data on the quality of
the HHA's respective training/education programs. The commenter stated
that data should measure the impact of the training/education program
from the patient's, family caregiver's, and, as appropriate, from the
direct care staff's perspectives. CMS should consider whether a quality
measure in this area is appropriate and feasible. Another commenter
wrote that CMS's proposed rule, ``Medicare and Medicaid Programs:
Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers'' (78 FR 79082, 79111, December
27, 2013) would require the home health agency to develop an emergency
preparedness plan and conduct training and a mock drill or table top
exercise annually, and that these requirements should be included as a
standard under the organization and administration CoP.
Response: We appreciate suggestions related to the development of
additional CMS data collection items and quality measures. Furthermore,
we appreciate the suggestion related to the placement of future
emergency preparedness requirements. However, these topics are not
within the scope of this rule and are addressed in separate rule
(Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers, 81 FR 63859).
Comment: One commenter expressed concern on the economic impact to
rural communities will lead to barriers to access in some areas due to
a combination of negative margins, new standards, and limited referral
sources.
Response: As its measure of significant economic impact, HHS uses a
change in revenue of more than 3 to 5 percent. We estimate that the
cost of this rule on a per-HHA basis is minimal (approximately a
$30,000 net increase in burden per non-accredited HHA in the 1st year,
and a $15,000 savings increase for accredited HHAs in the 1st year).
Furthermore, many of the burdens occur on a one-time basis as HHAs
update their forms, and policies and procedures to conform to the
updated requirements. We believe that this rule offers sufficient
implementation flexibility to be adapted to the operations of a wide
variety of HHAs, including those in rural areas.
Comment: One commenter encourages CMS to think creatively about how
to leverage HHAs and home health services to improve health outcomes
and quality of care, and avoid unnecessary hospitalizations and other
institutional admissions. For example, the commenter suggested that if
HHA personnel were providing services to an individual, and while, in
the course of working with the family caregiver, saw that the family
caregiver had health needs, the HHA staff could offer advice, make
referrals, or provide a simple service to the caregiver that could
improve their health (indirectly assisting the home health patient),
especially if the caregiver is receiving Medicare or Medicaid services.
Another commenter suggested that CMS ensure the operational capability
of providers by requiring those agencies with new provider numbers to
demonstrate proof of sufficient capital to operate for 1 year, and by
requiring that existing agencies provide a $100,000 surety bond.
Additionally, one commenter suggested that CMS establish a 2-year
moratorium on the entry of new home health agencies into counties with
demonstrable over-penetration (subject to certain exceptions). Another
commenter suggested CMS identify and withhold payment for aberrant
episodes and LUPA claims. Another commenter suggested that CMS consult
with the Inspector General of the Department of Health and Human
Services to establish a claims validation process by screening each
claim (or a sample of claims) so that, before payment is made, the
Secretary would validate claims on the basis of an HHA's submission of
OASIS assessments (or some other data set approved for home health
agencies).
Response: We appreciate the commenters' suggestions. However, we
believe these comments are outside the scope of this rule.

V. Provisions of the Final Regulations

We are adopting as final the provisions set forth in the proposed
rule published in the Federal Register on October 9, 2014 (79 FR
61164), with the following changes:
Revised the definition of ``representative'' at Sec.
484.2 for additional clarity.
Revised 484.45(c)(2) to align the regulatory text with the
current CMS guidelines for data transmission by replacing the
requirement that test data

[[Page 4561]]

be transmitted to the ``state agency'' with a requirement that test
data be transmitted to the ``QIES ASAP system.'' We proposed to require
that an HHA must, ``Successfully transmit test data to the state agency
or CMS OASIS contractor.'' On January 1, 2015, CMS changed the OASIS
transmission guidelines to require that an HHA must successfully
transmit test data to the QIES ASAP System or CMS OASIS contractor. We
have revised the final rule at Sec. 484.45 to reflect this change and
maintain consistency between the transmission guidelines and the
regulatory requirements. We ordinarily publish a notice of proposed
rulemaking in the Federal Register and invite public comment on the
proposal. This procedure can be waived, however, if an agency finds
good cause to do so. In section VI of this preamble, we have provided
our rationale for finalizing these provisions without prior notice and
comment.
Revised Sec. 484.50(a)(1) to clarify that it is the
patient's legal representative that must be informed of the patient
rights information prior to the start of care.
Revised Sec. 484.50(a)(1)(i) to require that an HHA must
provide each patient with written notice regarding the HHA's transfer
and discharge policies. This requirement was originally proposed at
484.50(d).
Redesignated proposed Sec. 484.50(a)(1)(ii) as Sec.
484.50(a)(3).
Redesignated proposed Sec. 484.50(a)(2) as Sec.
484.50(a)(1)(ii) and removed the requirement that HHA administrators
are expected to receive patient questions.
Redesignated proposed Sec. 484.50(a)(3) as Sec.
484.50(a)(1)(iii).
Redesignated proposed Sec. 484.50(a)(4) as Sec.
484.50(a)(2), and clarified that a signature confirming receipt of the
notice of patient rights is only required from a patient or a patient's
legal representative.
Revised Sec. 484.50(a)(3), requiring that the HHA must
provide verbal notice of the patient's rights no later than the
completion of the second visit from a skilled professional.
Added new Sec. 484.50(a)(4), requiring that the HHA
provide written notice of the patient's rights and the HHA's discharge
and transfer policies to a patient-selected representative within 4
business days after the initial evaluation visit.
Revised 484.50(b) to replace the term ``incompetence''
wherever it appears with the more precise term ``lack legal capacity to
make health care decisions.''
Revised Sec. 484.50(c)(4)(i) to clarify that patients
have the right to participate in and be informed about all assessments,
rather than just the comprehensive assessment.
Removed the requirement at Sec. 484.50(c)(4)(iii)
regarding providing a copy of the plan of care to each patient.
Revised Sec. 484.50(c)(10) to require HHAs to provide
contact information for a defined group of federally-funded and state-
funded entities.
Revised Sec. 484.50(d) to remove the requirement for HHAs
to provide patients with information regarding HHA admission policies
and clarified that the ``transfer and discharge policies'' are those
set forth in paragraphs (1) through (7) of this standard.
Revised Sec. 484.50(d)(1) to clarify that HHAs are
responsible for making arrangements for a safe and appropriate
transfer.
Revised Sec. 484.50(d)(3) to clarify that discharge is
appropriate when the physician and the HHA both agree that the patient
has achieved the measurable outcomes and goals established in the
individualized plan of care.
Revised Sec. 484.50(e)(1)(i) to clarify that the subject
matter about which patients may make complaints is not limited to those
subjects specified in the regulation. HHAs must investigate all such
complaints.
Revised Sec. 484.50(e)(1)(iii) to specify that HHAs must
take action to prevent retaliation while a patient complaint is being
investigated.
Revised Sec. 484.50(e)(2) to specify that circumstances
of mistreatment, neglect, abuse, or misappropriation of patient
property must be reported in accordance with the requirements of state
law.
Added a requirement at Sec. 484.55(c)(6)(i) and (ii) that
the comprehensive assessment must include information about caregiver
willingness and ability to provide care, and availability and
schedules.
Added a requirement at Sec. 484.60 that patient and
caregiver receive education and training including written instructions
outlining medication schedule/instructions, visit schedule and any
other pertinent instruction related to the patients care and treatments
that the HHA will provide, specific to the patient's care needs.
Moved proposed Sec. 484.60(a)(3) to Sec.
484.60(a)(2)(xii), making it applicable to all patients, and removed
the terms ``low,'' ``medium,'' and ``high.''
Revised Sec. 484.60(b)(1) to permit drugs, services and
treatment to be ordered by any physician, not just the one responsible
for the patient's plan of care.
Revised Sec. 484.60(b)(4) to permit any nurse acting in
accordance with state licensure requirements to receive verbal orders
from a physician.
Added requirements at Sec. 484.60(d)(1) and (2) that HHAs
must assure communication with all physicians involved in the plan of
care, and integrate orders from all physicians involved in the plan of
care to assure the coordination of all services and interventions
provided to the patient.
Redesignated proposed Sec. 484.60(d)(1) through (3) as
Sec. 484.60(d)(3) through (5).
Added a requirement at Sec. 484.60(e), Written
information to the patient.
Revised Sec. 484.65 to require that QAPI program
indicators include the use of emergent care services.
Revised Sec. 484.75(b)(7) to require skilled
professionals to communicate with all physicians involved in the plan
of care.
Revised Sec. 484.80(b)(3)(xiii) by withdrawing part of
the provision under home health aide training requirements for aides to
recognize and report changes in pressure ulcers. We ordinarily publish
a notice of proposed rulemaking in the Federal Register and invite
public comment on the proposal. This procedure can be waived, however,
if an agency finds good cause to do so. In section VI of this preamble,
we have provided our rationale for finalizing these provisions without
prior notice and comment.
Revised Sec. 484.80(g)(1) by removing the requirement
that the skilled professional who is responsible for the supervision of
a home health aide must be the individual who prepares written patient
care instructions for the home health aide.
Revised Sec. 484.80(h)(1)(i) by adding a requirement that
the registered nurse or other appropriate skilled professional who
conducts supervision of a home health aide must be familiar with the
patient, the patient's plan of care, and the written patient care
instructions described in Sec. 484.80(g).
Revised Sec. 484.80(h)(1)(ii) by removing the word
``potential deficiency'' and replacing it with ``area of concern.''
Redesignated Sec. 484.22--Emergency Preparedness under
subpart B as Sec. 484.102 under subpart C to align with CoP's related
to ``Organizational Environment.'' Section 484.22 was implemented as
part of the Emergency Preparedness final rule published on September
16, 2016 (81 FR 63859).
Revised the requirement at Sec. 484.105 to clarify that
an HHA must

[[Page 4562]]

organize, manage, and administer its resources to attain and maintain
the highest practicable functional capacity, including providing
optimal care to achieve the goals and outcomes identified in the
patient's plan of care, for each patient's medical, nursing, and
rehabilitative needs.
Added a requirement at Sec. 484.105(b)(1)(i) that the
administrator must report to the governing body.
Revised Sec. 484.105(b)(1)(iii) to require that the
administrator assures that a clinical manager is available during all
operating hours.
Added a requirement at Sec. 484.105(b)(1)(iv) that the
administrator must ensure that the HHA employs qualified personnel,
including assuring the development of personnel qualifications and
policies.
Revised Sec. 484.105(b)(2) to clarify that an individual
that is pre-designated to fill the administrator role in the absence of
the administrator (including the clinical manager) must be qualified to
do so.
Revised Sec. 484.105(c) to specify that one or more
qualified individuals must provide oversight of all patient care
services and personnel.
Revised Sec. 484.105(c) Clinical manager by retaining a
description of the clinical manager's duties while relocating the
personnel specifications for this role to new Sec. 484.115(c), which
sets for the specific personnel requirements for the clinical manager.
Removed Sec. 484.105(c)(6).
Added a requirement at Sec. 484.110(a)(4) that the
clinical record must include contact information for the patient's
primary caregiver(s).
Revised Sec. 484.110(a)(6)(i) by changing the discharge
summary deadline for completion from 7 calendar days to 5 business
days.
Revised Sec. 484.110(a)(6)(ii) by changing the transfer
summary deadline for completion from 2 calendar days to 2 business days
of a planned transfer, if the patient's care will be immediately
continued in a health care facility.
Added Sec. 484.110(a)(6)(iii), requiring that a completed
transfer summary must be sent within 2 business days of becoming aware
of an unplanned transfer, if the patient is still receiving care in a
health care facility at the time when the HHA becomes aware of the
transfer.
Revised Sec. 484.110(e), requiring that a patient's
clinical record (whether hard copy or electronic form) must be made
available to a patient, free of charge, upon request at the next home
visit, or within 4 business days (whichever comes first).
Revised the personnel qualification requirements for HHA
administrators at Sec. 484.115(a) to grandfather in currently employed
HHA administrators.
Added Sec. 484.115(c) to specify personnel qualifications
for clinical managers.
Redesignated paragraphs Sec. 484.115 (c) through (m) as
(d) through (n).
Revised the proposal at Sec. 484.115(e) licensed
practical nurse to utilize existing regulatory language regarding
vocational nurses, and align the requirement with state practice acts.
We ordinarily publish a notice of proposed rulemaking in the Federal
Register and invite public comment on the proposal. This procedure can
be waived, however, if an agency finds good cause to do so. In section
VI of this preamble, we have provided our rationale for finalizing
these provisions without prior notice and comment.
Made technical changes to the requirements at Sec.
484.115(f) through (i) to align with current personnel qualification
requirements for occupational therapists, occupational therapy
assistants, physical therapists, and physical therapy assistants.

VI. Good Cause To Waive Notice and Comment Rulemaking

As discussed in section IV of this preamble, at Sec. 484.45 we
proposed to require that an HHA must, ``Successfully transmit test data
to the state agency or CMS OASIS contractor.'' However, on January 1,
2015, CMS changed the OASIS transmission guidelines to require that an
HHA must successfully transmit test data to the QIES ASAP System or CMS
OASIS contractor. We have revised the final rule at Sec. 484.45 to
reflect this change and maintain consistency between the transmission
guidelines and the regulatory requirements.
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposal. The notice
of proposed rulemaking includes a reference to the legal authority
under which the rule is proposed, and the terms and substance of the
proposed rule or a description of the subjects and issues involved.
This procedure can be waived, however, if an agency finds good cause
that a notice-and-comment procedure is impracticable, unnecessary, or
contrary to the public interest and incorporates a statement of the
finding and its reasons in the rule issued. We believe that finalizing
the previously proposed language is contrary to the public interest
because it conforms our rules to transmission guidelines that have
changed since this rule has been proposed. We wish to waive notice and
comment for rulemaking because waiting until a future rulemaking to
resolve this inconsistency would create unnecessary confusion within
the HHA community. Such confusion would likely lead to inconsistent
compliance with either the regulations or the transmission guidelines,
potentially leading to information gaps in CMS databases that could
negatively impact HHA payments and the accuracy of quality measure
information that is reported to the public. Because this change is
operational, non-controversial, and has already been implemented at the
sub-regulatory level, we find good cause to waive the notice of
proposed rulemaking related to this change, and to issue this provision
of the final rule.
In section IV of this preamble, at Sec. 484.80 ``Condition of
participation: Home Health Aide Services,'' we proposed to add a
requirement under home health aide training at Sec. 484.80(b)(3)(xiii)
to require home health aides to be trained on ``Recognizing and
reporting changes in skin condition, including pressure ulcers.'' We
believe that it is important for home health aides to be taught to
recognize and report changes in skin condition; however, during the
process of developing this final rule, CMS stakeholders identified
concerns that this requirment is beyond the aide's scope of practice
and possibly the aide's ability to report changes in pressure ulcers.
Out of an abundance of caution, we are withdrawing the proposal for the
aide to be taught to recognize and report changes in pressure ulcers.
The revision will require only recognizing and reporting changes in
skin condition.
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposal. The notice
of proposed rulemaking includes a reference to the legal authority
under which the rule is proposed, and the terms and substance of the
proposed rule or a description of the subjects and issues involved.
This procedure can be waived, however, if an agency finds good cause
that a notice-and-comment procedure is impracticable, unnecessary, or
contrary to the public interest and incorporates a statement of the
finding and its reasons in the rule issued. We believe that finalizing
the previously proposed language is contrary to the public interest
because requiring home health aides to perform skills that are
inconsistent with their state scope of practice requirements would
create a direct conflict between state and federal requirements. This
direct conflict would

[[Page 4563]]

impede the ability of home health aides to do their jobs efficiently
and effectively, and would negatively impact patient care and outcomes.
Therefore, we find good cause to waive the notice of proposed
rulemaking related to this change, and to withdraw this provision from
the final rule.
In section IV of this preamble, at Sec. 484.115 ``Condition of
participation: Personnel qualifications,'' we proposed to remove the
word ``vocational'' from the current CFR at Sec. 484.4, ``Personnel
qualifications.'' During a meeting of state leaders that occurred
outside of the public comment process we were notified that two states
currently use the term ``licensed vocation nurse.'' We believe that
there are no significant substantive differences that exist between
LPNs and LVNs other than the geographical locations and local variants
in nomenclature; there are no major differences in educational
preparation, licensure, roles, or skill sets. Therefore, after
discussions with the states and an internal review we have amended
Sec. 484.115(e). We have withdrawn our proposal to delete the word
``vocational'' from the position title, and have amended the proposed
definition to utilize existing regulatory language inclusive of both
LVNs and LPNs. The final provision states: Licensed Practical
(vocational) Nurse. A person who has completed a practical (vocational)
nursing program, is licensed in the state where practicing, and who
furnishes services under the supervision of a qualified registered
nurse.
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposal. The notice
of proposed rulemaking includes a reference to the legal authority
under which the rule is proposed, and the terms and substance of the
proposed rule or a description of the subjects and issues involved.
This procedure can be waived, however, if an agency finds good cause
that a notice-and-comment procedure is impracticable, unnecessary, or
contrary to the public interest and incorporates a statement of the
finding and its reasons in the rule issued. We believe that finalizing
the previously proposed language is contrary to the public interest
because the only significant difference between LPNs and LVNs is the
geographical locations in which these terms are used. The terms are
used interchangeably, and continuing the use of both terms, as has been
required in the HHA CoPs for more than a decade, will have no impact on
patient care or HHA operations. Therefore, we find good cause to waive
the notice of proposed rulemaking related to this change, and to
withdraw this provision from the final rule.

VII. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We solicited public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs) during the proposed rulemaking.

Assumptions and Estimates

We have made several assumptions and estimates in order to assess
both the time that it would take for an HHA to comply with the new
provisions as well as the costs associated with that compliance. We
have detailed these assumptions and estimates in Table 1, and have used
these assumptions as the basis for both the Collection of Information
and the Regulatory Impact Analysis sections of this rule.

Table 1--Assumptions and Estimates Used Throughout the Information
Collection and Impact Analysis Sections
------------------------------------------------------------------------

------------------------------------------------------------------------
Number of Medicare participating HHAs nationwide in 2015 12,602
Number of Medicare participating HHAs that are 4,972
accredited in 2015.....................................
Number of HHA patients in Medicare participating HHAs 17,751,840
nationwide in 2014.....................................
Number of HHA patients in Medicare participating in 7,005,548
2015, accredited HHAs..................................
Number of Medicare beneficiaries in HHAs in 2015........ 3,475,730
Average number of new HHAs per year (based on growth in 455
the number of HHAs from 2010-2015).....................
Average number of new, non-accredited HHAs per year 14
(based on growth in the number of HHAs from 2010-2015).
Average number of patients per HHA per year............. 1,409
Hourly rate of registered nurse *....................... $63
Hourly rate of HHA office employee *.................... $26
Hourly rate of administrator *.......................... $98
Hourly rate of home health aide *....................... $20
Hourly rate of clinical manager *....................... $85
Hourly rate of QAPI coordinator **...................... $63
Hourly rate of physician *.............................. $180
Hourly rate of therapist (average of PT, OT, SLP) *..... $72
Hourly rate of clinician (average of Nurse, Aide, $60
Therapist) *...........................................
------------------------------------------------------------------------
* Estimate from the Bureau of Labor Statistics Occupational Outlook
Handbook, 2014-2015 edition; includes 100 percent benefit and overhead
package.
** Based on a registered nurse fulfilling this role.

[[Page 4564]]

Collection of Information Requirements--Discussion and Summary

A. ICRs Regarding Condition of Participation: Reporting OASIS
Information (Sec. 484.45)

Section 484.45 states that HHAs must electronically report all
OASIS data in accordance with Sec. 484.55. Specifically, an HHA would
have to encode and electronically transmit each completed OASIS
assessment to the state agency or the CMS OASIS contractor within 30
days of completing an assessment of a beneficiary. The burden
associated with this requirement is the time and effort necessary to
conduct the OASIS assessment on a beneficiary and encode and transmit
the information to the state agency or the CMS OASIS contractor. We did
not make any changes to the OASIS data set, so the time to conduct the
OASIS assessment on a beneficiary has stayed the same. We did change
the destination of transmitted data; however, this does not change the
time necessary to encode and transmit the data. While this requirement
is subject to the PRA, the burden is currently approved under OMB
control number 0938-1279.

B. ICRs Regarding Condition of Participation: Patient Rights (Sec.
484.50)

Section 484.50 implements the patient rights provisions of section
1891(a)(1) of the Act, which are currently specified in Sec. 484.10.
The purpose is to recognize certain rights that home health patients
are entitled to, and protect their rights. HHAs are required to inform
each patient of their rights. In Sec. 484.50, we require HHAs to
inform patients about the expected outcomes of treatment and the
factors that could affect treatment. The HHAs are asked to devote
efforts to improve patient's health literacy which lead to an increased
comprehension of diagnosis and treatment for both patients and family.
Increased comprehension allows patients to remain active and make the
best possible decisions for their medical care. The requirements
currently specified in Sec. 484.10, that are retained in the final
rule include:
An HHA must provide the patient and representative (legal
or patient-selected) with an oral and a written notice of the patient's
rights in a manner that the individual can understand. The HHA must
also document that it has complied with the requirements of this
section.
An HHA must document the existence and resolution of
complaints about the care furnished by the HHA that were made by the
patient, representative, and family.
An HHA must advise the patient in advance of the
disciplines that will furnish care, the plan of care, expected
outcomes, factors that could affect treatment, and any changes in the
care to be furnished.
An HHA must advise the patient of the HHA's policies and
procedures regarding the disclosure of patient records.
An HHA must advise the patient of his or her liability for
payment.
An HHA must advise the patient of the number, purpose, and
hours of operation of the state home health hotline.
In addition to the retained requirements, we require that HHAs must
also advise the patient of the following:
The names, addresses, and telephone numbers of specified
State-funded and federally-funded entities.
The right to access auxiliary aids and language services,
and how to access these services.
We foresee that HHAs will develop a standard notice of rights to
fulfill the requirements contained in Sec. 484.50(a) of this section.
A copy of the signed notice would serve as documentation of compliance.
We estimate that a home health agency will utilize an administrator to
develop the patient rights form. All newly established HHAs would need
to develop a notice of patient rights document. In order to speed up
the process of becoming Medicare-approved, the majority of new HHAs are
choosing to become accredited by a national accrediting organization
for Medicare deeming purposes. The patient rights standards and patient
notification requirements of the national accrediting organizations
would meet or exceed those included in this rule; therefore this rule
does not impose a burden upon those new HHAs that choose to obtain
accreditation status for Medicare deeming purposes. We estimate that it
would take 8 hours for each new non-accredited home health agency to
develop the form. The total annual burden for new HHAs is 112 hours (8
hours per HHA x 14 HHAs). The estimated cost associated with this
requirement is $784 per HHA and $10,976 for all new non-accredited
HHAs, annually. In addition, we estimate that it would take each
existing HHA 1 hour to update its existing patient rights form, for a
one-time total of 12,602 hours and a cost of $1,234,996.
The burden associated with Sec. 484.50(e), which requires an HHA
to document both the existence of a patient complaint regarding care
provided (or not provided) or inappropriate treatment by HHA staff and
those working on behalf of the HHA, and the resolution of the
complaint, would be the time and effort necessary to document a patient
complaint and its resolution. We estimate that, in a 1 year period, an
HHA would need to document complaints involving about 5 percent (70) of
its patients. We estimate that the documentation would require 5
minutes per investigation. HHAs accredited by the Joint Commission, the
Community Health Accreditation Partner, and the Accreditation
Commission for Health Care are already required by their accrediting
bodies to adhere to stringent patient rights violation investigation
and record-keeping standards; therefore accredited HHAs are not be
burdened by this new standard. The total annual burden per non-
accredited HHA (7,630) would be 6 hours (70 investigations x 5 minutes
per investigation/60).
We believe that the requirements of standard (f),
``Accessibility,'' related to providing information to patients in a
manner that can be understood would not impose a burden because all
HHAs have already attested to CMS that they are in compliance with the
requirements of Title VI of the Civil Rights Act of 1964, the Americans
With Disabilities Act, and section 504 of the Rehabilitation Act (see
42 CFR 489.10, as implemented by form HHS-690, currently approved under
OMB control number 0938-1279, current expiration August 31, 2017).
Since HHAs have already attested that they are in compliance with these
longstanding requirements, and since the requirements of this rule are
not intended to go beyond these statutes, no new burden would be
imposed.

C. ICRs Regarding Condition of Participation: Comprehensive Assessment
of Patients (Sec. 484.55)

Section 484.55 requires the HHA to conduct, document and update,
within a defined timeframe, a patient-specific comprehensive assessment
that identifies the patient's need for HHA care and services, and the
patient's need for physical, psychosocial, emotional and spiritual
care. Although we have included additional areas of focus within the
patient assessment requirements, these areas are already addressed in
the OASIS data set that HHAs have been required to collect since 1999.
Therefore, no new burden has been added with these changes. The
information collection burden associated with the OASIS data set is
currently approved under OMB control

[[Page 4565]]

number 0938-1279. The current expiration date is December 31, 2019.

D. ICRs Regarding Condition of Participation: Care Planning,
Coordination of Services, and Quality of Care (Sec. 484.60)

The requirements in this section reflect an interdisciplinary,
coordinated approach to home health care delivery. Section 484.60
requires that each patient's written plan of care specify the care and
services necessary to meet the patient specific needs identified in the
comprehensive assessment. Additionally, the written plan of care will
be required to contain the measurable outcomes that the HHA anticipates
will occur as a result of implementing and coordinating the plan of
care. This section incorporates several of the requirements under
former Sec. 484.18. Section 484.18 consists of longstanding
requirements that implement statutory provisions found in sections
1835, 1814, and 1891(a) of the Act. While these requirements are
subject to the PRA, the associated collection is currently approved
under OMB control number 0938-0365.\2\ Additionally the plan of care
must also specify the patient and caregiver education and training
specific to the patient's care needs. A typical HHA patient will have
one original plan of care, and we believe compliance with the new plan
of care requirements, such as addressing each patient's psychosocial
status and interventions to address readmission risk factors, will
impose a new burden of 10 minutes per patient, per plan of care. We
believe that most HHAs are already addressing these areas during the
care planning process, so for purposes of this analysis only, we assume
that 90 percent of HHAs are already compying with these requirements
and that 10 percent will need to comply. We estimate that the 1,260
HHAs that are not already addressing these new factors in their care
planning process will use 296,482 hours (1,409 patients per HHA x 0.167
hours per patient x 1,260 HHAs) at a cost of $18,678,366 for a nurse to
document the new required information in the plan of care.
---------------------------------------------------------------------------

\2\ This collection will be discontinued when a new collection
is approved which will better align the PRA package with new
regulations.
---------------------------------------------------------------------------

Section 484.60(a) requires that each patient's written plan of care
be established and periodically reviewed by a doctor of medicine,
osteopathy, or podiatry. While HHAs average 1,409 home health patient
admissions per year, on average 276 of those are Medicare patients.
Having a doctor of medicine, osteopathy, or podiatry establish and
periodically review the HHA plan of care is also a requirement for
Medicare payment; therefore HHAs do this in the absence of this
requirement. Thus this requirement will not impose a burden with
respect to those 276 Medicare patients. The anticipated burden
associated with this requirement involves a member of the office
support staff who would facilitate interaction with the physician with
regard to non-Medicare patients. We estimate that this would take 5
minutes per admission for a total estimated burden of 94 hours per HHA
([1,133 non-Medicare admits per year x 5 minutes]/60 minutes per hour).
Section 484.60(a)(4) and (b)(1) requires HHAs to conform and
fulfill all medical orders issued in writing or telephone (and later
authenticated) by a patient's physician or qualified medical
professional. We believe compliance with this requirement will
constitute a usual and customary business practice and will not be
subject to the PRA in accordance with the implementing regulations of
the PRA at 5 CFR 1320.3 (b)(2). Issuing orders for patient care is one
of the most fundamental tasks performed by physicians. Likewise,
documenting and adhering to physician orders is one of the most
fundamental tasks performed by the physician and all other clinicians
within a patient's health care team, including the nurses, therapists,
and social workers that are involved in home health care.
Section 484.60(c) requires an HHA to review, revise and document
the plan on a timely basis. The burden associated with these
requirements is the time and effort associated with reviewing,
revising, and maintaining the plan of care. We believe compliance with
the new plan of care requirements, such as addressing each patient's
psychosocial status and interventions to address readmission risk
factors, will impose a new burden of 5 minutes per patient, per updated
plan of care. Assuming that a typical HHA patient will have one update
to the plan of care, we estimate that all HHAs will use 147,353 hours
(1,409 patients per HHA x 0.083 hours per patient x 1260 HHAs) at a
cost of $9,283,329 for a nurse to document the new required information
in the plan of care.
Section 484.60(e) is a new provision that was added based on
comments and which partially replaces other requirements previously
placed elsewhere. This provision requires the HHA to provide written
instructions to the patient and care giver outlining visit schedule
including frequency of visits, medication schedule/instructions,
treatments administered by HHA personnel and personnel acting on the
behalf of the HHA, pertinent instructions related to patient care, and
the name and contact information of the HHA clinical manager. Giving
written instruction to the patient and care giver outlining the
medication schedule/instructions, visit schedule, pertinent instruction
related to the patient's care and treatments and contact information of
the HHA has been a long standing practice in the home health industry
and is one of the most fundamental elements in patient education. For
purposes of this analysis only, we assume that 90 percent of HHAs are
already providing this information and 10 percent are not. We estimate
that it would take 20 minutes to provide a patient with this written
information and that each patient will receive written information
twice while under the HHA's care. Based on these assumptions, we
estimate that this provision will impose 1,182,376 hours of burden at a
cost of $74,489,688 for a nurse to provide the written information.

E. ICRs Regarding Condition of Participation: Quality Assessment and
Performance Improvement (QAPI) (Sec. 484.65)

Section 484.65 requires HHAs to develop, implement, maintain and
evaluate an effective, data driven quality assessment and performance
improvement program. We have not prescribed the structures and methods
for implementing this requirement and have focused the condition toward
the expected results of the program. This provides flexibility to the
HHA, as it is free to develop a creative program that meets the HHA's
needs and reflects the scope of its services. This new provision
replaces the former conditions at Sec. 484.16, ``Group of professional
personnel,'' and Sec. 484.52, ``Evaluation of an agency's program.''
The first standard under Sec. 484.65 requires that an HHA's
quality assessment and performance improvement program must include,
but not be limited to, the use of objective measures to demonstrate
improved performance. The second standard requires the HHA to track its
performance to assure that improvements are sustained over time. The
third standard requires that the HHA must set priorities for
performance improvement, consider prevalence and severity of identified
problems, and give priority to improvement activities that affect
clinical outcomes. Lastly, the fourth standard requires the HHA to
conduct performance improvement

[[Page 4566]]

projects that reflect the scope, complexity, and past performance of
the HHA's services and operations, and document these projects.
We believe the writing of internal policies governing the HHA's
approach to the development, implementation, maintenance, and
evaluation of the quality assessment and performance improvement
program, as described in Sec. 484.65, will impose a new burden. We
want HHAs to utilize maximum flexibility in their approach to quality
assessment and performance improvement programs. Flexibility is
provided to HHAs to ensure that each program reflects the scope of its
services. We believe that this requirement provides a performance
expectation that HHAs will set their own QAPI plan and goals and use
the information to continuously strive to improve their performance
over time. Given the variability across HHAs and the flexibility
provided, we believe that the burden associated with writing the
internal policies governing the approach to the development,
implementation, and evaluation of the quality assessment and
performance improvement program will reflect that diversity. We
estimate that the burden associated with writing the internal policies
would be an average of 4 hours annually per HHA, for an industry-wide
total of 30,520 hours. (4 hours per HHA x 7,630 non-accredited HHAs),
and an industry-wide cost of $1,922,760 (30,520 hours x $63/hour).
HHAs accredited by the Joint Commission, the Community Health
Accreditation Partner, and the Accreditation Commission for Health Care
are already required by their accrediting bodies to undertake and
document performance improvement projects. In the absence of
accreditation requirements, we believe that most HHAs already document
the quality projects that they have undertaken as part of standard
business practice. For purposes of this analysis only, we assume that
10 percent of non-accredited HHAs would use additional resources to
document their quality projects. We we estimate that the affected HHAs
would use 1 hour per quarter to document performance improvement
project activities and that the QAPI coordinator would perform this
function, for a total of 3,052 hours (0.1 x 7,630 non-accredited HHAs x
1 hour per quarter x 4 quarters per year) at a cost of $192,276.

F. ICRs Regarding Condition of Participation: Infection Prevention and
Control (Sec. 484.70)

Section 484.70 requires an HHA to maintain and document an
infection control program with the goal of preventing and controlling
infections and communicable diseases. Specifically, Sec. 484.70(b)
states that the HHA must maintain a coordinated agency-wide program for
the surveillance, identification, prevention, control, and
investigation of infectious and communicable diseases that is an
integral part of the HHA's QAPI program. Section 484.70(c) requires
that each HHA provide infection control education to staff, patients,
and caregivers. All aspects of the infection prevention and control
CoP, from teaching patients and caregivers about proper prevention
practices to monitoring infectious disease occurrences within an HHA's
population to cooperating with outside bodies during disease outbreaks,
are current standards of practice. Since health care-acquired
infections have been a source of significant research, education, and
training efforts by both the public and private health care sectors for
more than a decade, we believe that all HHAs already have infection
prevention and control programs. The burden associated with the
infection prevention and control program would be the time necessary to
document the program. We estimate that each HHA will spend 1 hour per
quarter documenting its infection prevention and control program, for a
total of 50,408 hours at a cost of $3,175,704 for a nurse to complete
the documentation.

G. ICRs Regarding Condition of Participation: Skilled Professional
Services (Sec. 484.75)

We consolidated former provisions governing skilled nursing
services at Sec. 484.30, therapy services at Sec. 484.32, and medical
social services at Sec. 484.34, under one new condition, Sec. 484.75.
Section 484.75 requires skilled professionals who provide services to
HHA patients as employees or under arrangement to participate in all
aspects of care. This includes, but is not limited to, participation in
the on-going patient assessment process; development and maintenance of
the interdisciplinary plan of care; patient, caregiver, and family
counseling; patient and caregiver education; and communication with
other health care providers. Section 484.75 also requires skilled
professionals to be actively involved in the HHA's QAPI program and
participate in HHA in-service trainings. Furthermore, Sec. 484.75
requires skilled professional services to be supervised. In the
proposed rule that published on October 9, 2014 (79 FR 61114), we
incorrectly stated that these requirements would be exempt under the
implementing regulations of the PRA at 5 CFR 1320.3(b)(3). We still
maintain that the burden associated with these requirements would be
exempt; however, the correct exemption is located at 5 CFR
1320.3(b)(2). These are usual and customary business practices.
Clinician involvement in patient care, quality improvement efforts, and
continuing education are all commonly accepted as good medical practice
and are typically part of state licensure requirements. The supervision
of clinician services is also standard medical practice to ensure that
patient care is delivered in a safe and effective manner.

H. ICRs Regarding Condition of Participation: Home Health Aide Services
(Sec. 484.80)

This section governs the requirements for home health aide
services. Many requirements in this section directly mirror the
statutory requirements of sections 1891 and 1861 of the Act and include
the following requirements: (1) The HHA must maintain sufficient
documentation to demonstrate that training requirements are met; (2)
The HHA's competency evaluation must address all required subjects; (3)
The HHA must maintain documentation that demonstrates that requirements
of competency evaluation are met; and (4) a registered nurse or
appropriate skilled professional prepares written instructions for care
to be provided by the home health aide.
We retained, for the most part, the requirements at previous Sec.
484.36, but place them in a new condition of participation at Sec.
484.80. We also added the provisions from previous Sec. 484.4
concerning the qualifications for home health aides. All home health
aide services must be provided by individuals who meet the personnel
requirements and training criteria as specified. An HHA is required to
maintain documentation that each home health aide meets these
qualifications as specified in Sec. 484.80(a). The burden associated
with these standards is the time required to document that each new
aide meets the qualification requirements. We estimate that it will
take 5 minutes per newly hired home health aide per year to document
the information. We assume that the average home health agency would
replace 30 percent of its home health aides in a given year, or roughly
two home health

[[Page 4567]]

aides a year based an average of six home health aide FTEs (Basic
Statistics About Home Care Updated 2010, National Association for Home
Care, http://www.nahc.org/facts/10HC_Stats.pdf). Based on an estimate
of 5 minutes per newly hired aide and two newly hired aides per agency,
per year, we estimate that there will be 2,100 annual burden hours ([5
minutes per aide x 2 aides per HHA]/60 minutes per hour x 12,602 HHAs)
for the home health industry. We assume, based on our experience with a
similar requirement in the hospice environment, that an office employee
($26/hour) would perform this function at a cost of $4 per HHA per
year. The total cost for all HHAs is $54,600 (2,100 hours x $26/hour).
Section 484.80(b)(1) through (3) sets forth the content and
duration of the home health aide classroom and supervised practical
training. With respect to the recordkeeping requirements, Sec.
484.80(b)(4) states that an HHA is required to maintain documentation
that demonstrates that the requirements of this standard have been met.
The burden associated with this requirement would be the time and
effort necessary to document the information and maintain the
documentation as part of the HHAs records. We estimate that it would
take each of the 12,603 HHAs 5 minutes per newly hired aide per year to
document that the requirements of this standard have been met. The
estimated annual burden is 2,100 hours ([5 minutes per aide x 2 aides
per HHA]/60 minutes per hour x 12,602 HHAs). The cost burden associated
with this requirement is $54,600, based on an office employee
completing the documentation ($26/hour x 2,100 hours).
Section 484.80(c) contains the standard for competency evaluation.
An individual could furnish home health services on behalf of an HHA
only after that individual has successfully completed a competency
evaluation program as described in this section. With respect to the
recordkeeping requirements, Sec. 484.80(c)(5) states that an HHA is
required to maintain documentation that demonstrates that the
requirements of this standard have been met. The burden associated with
this requirement would be the time and effort necessary to document the
information and maintain the documentation as part of the HHAs records.
We estimate that it would take each of the 12,602 HHAs 5 minutes per
newly hired aide per year to document that the requirements of this
standard have been met. The estimated annual burden is 2,100 hours ([5
minutes per aide x 2 aides per HHA]/60 minutes per hour x 12,602 HHAs).
The cost burden associated with this requirement is $54,600, based on
an office worker completing the documentation ($26/hour x 2,100 hours).
Section 484.80(d) states that a home health agency is required to
maintain documentation that all home health aides have received at
least 12 hours of in-service training during each 12-month period. The
burden associated with this requirement would be the time and effort
necessary to document and maintain records of the required in-service
training. We assume that it would require 5 minutes per aide to
document the in-service training, and that these trainings would be
conducted on a quarterly basis, for a total of approximately 2 hours
per HHA, annually, to meet this requirement ([0.083 hours (aka 5
minutes) per aide per training x 4 trainings per year x 6 aides]/60
minutes per hour). The estimated total annual burden for this
requirement is 25,103 hours (0.083 hours (aka 5 minutes) per aide per
training x 4 trainings per year x 6 aides per HHA x 12,602 HHAs).
Section 484.80(g) states that written patient care instructions for
a home health aide must be prepared by a registered nurse or other
appropriate skilled professional who is responsible for the supervision
of a home health aide. The burden associated with this requirement
would be the time and effort necessary for a registered nurse or other
skilled professional to draft written patient care instructions for a
home health aide. Providing written patient care instructions is a
usual and customary business practice in accordance with the
implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Home health
aide licensure standards require aides to practice under the direction
of a nurse or other qualified medical professional. Likewise, the scope
of practice for nurses and other qualified medical professionals
includes the preparation of patient care instructions.
This rule at Sec. 484.80(h) also requires HHAs to document the
supervision of home health aides in accordance with specified
timeframes. Supervising employees to ensure the safe and effective
provision of patient care is standard business practice throughout the
health care community. Likewise, documenting that this supervision has
occurred for internal personnel, accreditation, and state and federal
compliance purposes constitutes a usual and customary business practice
and will not be subject to the PRA in accordance with the implementing
regulation of the PRA at 5 CFR 1320.3(b)(2).

I. ICRs Regarding Condition of Participation: Compliance With Federal,
State, and Local Laws and Regulations Related to the Health and Safety
of Patients (Sec. 484.100)

We are retaining most of the provisions of former Sec. 484.12,
``Compliance with Federal, State and local laws, disclosure of
ownership information and accepted professional standards and
principles'' with minor changes, now set forth at Sec. 484.100. As
stated in Sec. 484.100(a), the HHA is required to disclose to the
state survey agency at the time of the HHA's initial request for
certification the name and address of all persons with an ownership or
control interest in the HHA, the name and address of all officers,
directors, agents, and managers of the HHA, as well as the name and
address of the corporation or association responsible for the
management of the HHA and the chief executive and chairman of that
corporation or association. This requirement directly implements
section 1891 of the Act. This provision expands upon a similar
requirement currently contained in Sec. 405.1221(b). It would impose a
minimal burden of adding the necessary additional information to the
current disclosure used by HHAs as required by former Sec. 484.12(b),
which further reference the requirements of 42 CFR part 420, subpart C
related to Medicare Program Integrity requirements. We estimate that
modifying the current disclosure would require 5 minutes (0.083 hours)
per HHA, for a total of 1,046 hours for the HHA industry as a whole on
a one-time basis (0.083 hours per modification x 12,602 existing
agencies). Additionally, we estimate that it would require new HHAs 1
hour to develop a disclosure statement, for a total of 455 annual hours
industry wide each year (1 hour per new HHA x 455 new HHAs).

J. ICRs Regarding Condition of Participation: Organization and
Administration of Services (Sec. 484.105)

This section sets forth the organization and administration of
services provided by an HHA. It states that the HHA must organize,
manage, and administer its resources to attain and maintain the highest
practicable functional capacity for each patient regarding medical,
nursing, and rehabilitative needs as indicated by the plan of care.
Although there are reporting and documentation requirements associated
with the requirements, these activities are

[[Page 4568]]

standard business practice and would not impose a burden on HHAs. For
example, Sec. 484.105(d)(1) states that the parent HHA is responsible
for reporting all branch locations of the HHA to the state survey
agency at the time of the HHA's request for initial certification, at
each survey, and at the time the parent proposes to add or delete a
branch. Similarly, Sec. 484.105(e)(2) states that an HHA must have a
written agreement with another agency, with an organization, or with an
individual when that entity or individual furnishes services under
arrangement to the HHA's patients. We believe the burden associated
with the aforementioned will constitute a usual and customary business
practice and will not be subject to the PRA in accordance with the
implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Paragraph
(h) of this section, ``Institutional planning,'' imposes a minimal
burden of the time required by new HHAs to develop the initial plan and
by existing HHAs to review and revise the existing plan. We estimate
the burden for developing a new plan at 1\1/2\ hours (90 minutes) and
the burden for reviewing and revising an existing plan at 30 minutes.
Accredited HHAs are required by their accrediting bodies to engage in
institutional planning efforts that exceed these minimum federal
requirements; therefore this requirement would not impose a burden upon
accredited agencies. In addition, the vast majority of new HHAs are
entering the Medicare program via accreditation from a national
accrediting body; therefore this provision would not be imposing a
burden upon new agencies as well. The estimated annual burden for
existing HHAs is 3,815 hours ([7,630 existing non-accredited HHAs x 30
minutes]/60 minutes per hour). The estimated annual burden for
anticipated new HHAs is 21 hours (1.5 hours per HHA x 14 new HHAs).

K. ICRs Regarding Condition of Participation: Clinical Records (Sec.
484.110)

This section sets forth the requirements that clinical records
contain pertinent past and current findings, and are maintained for
every patient who is accepted by the HHA for home health services. A
clinical record containing pertinent past and current findings would be
maintained for every patient receiving home health services. All
entries in the clinical record must be authenticated, dated and timed,
which is usual and customary clinical practice and does not impose a
burden. Clinical records must be retained for 5 years after the month
the cost report for the records is filed with the intermediary. HHAs
are required to have written procedures that govern the use and removal
of records, and the conditions for release of information. This section
contains longstanding provisions that are specifically required in
section 1861(o) of the Act, and are necessary to preserve the patient's
privacy and the quality of care. The aforementioned documentation and
record retention requirements are considered usual and customary
business practices; therefore the burden associated with those
requirements will not be subject to the PRA in accordance with the
implementing regulation of the PRA at 5 CFR 1320.3(b)(2). At Sec.
484.110(a)(5) HHAs are required to send a copy of a patient's discharge
or transfer summary to the patient's primary care practitioner or other
health care professional who will be responsible for providing care and
services to the patient after discharge from the HHA, or the facility,
if the patient leaves HHA care to enter a facility for further
treatment. We estimate that an HHA would spend 5 minutes per patient
sending the discharge or transfer summary to the patient's next source
of health care services, for a total of 117 hours per average HHA
annually ([5 minutes per patient x 1,409 patients]/60 minutes per hour)
at a cost of $3,042 for an office employee to send the required
documentation ($26 per hour x 117 hours).
Furthermore, a patient's clinical record (whether hard copy or
electronic form) must be made available to a patient, free of charge,
upon request at the next home visit, or within 4 business days
(whichever comes first). The burden associated with this requirement is
the time and effort required to disclose a clinical record to an
appropriate authority. Making clinical records available to the
appropriate authority is part of the survey and certification process,
and we believe compliance with this requirement will constitute a usual
and customary business practice. Therefore, the burden associated with
this requirement will not be subject to the PRA in accordance with the
implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Furthermore,
we do not believe that this requirement would alter the frequency or
scope of requests stemming from other appropriate authorities such as
law enforcement.

L. ICRs Regarding Personnel Qualifications (Sec. 484.115)

In Sec. 484.115, we defer to state certification or state
licensure requirements in cases where personnel requirements are not
statutory or do not relate to a specific payment provision. As defined
in the implementing regulations of the PRA at 5 CFR 1320.3(b)(2), these
requirements are usual and customary business practices. In accordance
with the implementing regulations of the PRA at 5 CFR 1320.3(b)(3), we
believe this state requirement would exist even in the absence of the
federal requirement; therefore, the associated burden is not subject to
the PRA.

Table 2--Burden and Cost Estimates Associated With Information Collection Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hourly labor
Burden per Total annual cost of Total cost Total costs
Regulation section OMB control No. Respondents Responses response (in burden (in reporting of reporting ($)
hours) hours) ($) ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 484.50(a)*................ 0938-New........... 14 14 8 * 112 98 10,976 10,976
Sec. 484.50(a)*................ 0938-New........... 12,602 12,602 1 * 12,602 98 1,234,996 1,234,996
Sec. 484.50(e)................. 0938-New........... 7,630 534,100 0.083 44,330 63 2,792,790 2,792,790
Sec. 484.60(a)................. 0938-New........... 12,602 14,276,110 0.083 1,184,917 26 30,809,662 30,809,662
Sec. 484.60(a)................. 0938-New........... 1260 1,775,340 0.167 296,482 63 18,678,366 18,678,366
Sec. 484.60(c)................. 0938-New........... 1260 1,775,340 0.083 147,353 63 9,283,239 9,283,239
Sec. 484.60(e)................. 0938-New........... 1260 3,550,680 0.333 1,182,376 63 74,489,688 74,489,688
Sec. 484.65(e)*................ 0938-New........... 7,630 7,630 4 * 30,520 63 1,922,760 1,922,760
Sec. 484.65(d)................. 0938-New........... 763 3,052 1 3,052 63 192,276 192,276
Sec. 484.70.................... 0938-New........... 12,602 50,408 1 50,408 63 3,175,704 3,175,704
Sec. 484.80(a)................. 0938-New........... 12,602 25,204 0.083 2,100 26 54,600 54,600

[[Page 4569]]

Sec. 484.80(b)................. 0938-New........... 12,602 25,204 0.083 2,100 26 54,600 54,600
Sec. 484.80(c)................. 0938-New........... 12,602 25,204 0.083 2,100 26 54,600 54,600
Sec. 484.80(d)................. 0938-New........... 12,602 302,448 0.083 25,103 26 652,678 652,678
Sec. 484.100(a)................ 0938-New........... 12,602 12,602 0.083 1,046 98 102,508 102,508
Sec. 484.100(a)*............... 0938-New........... 455 455 1 * 455 98 44,590 44,590
Sec. 484.105(h)................ ................... 7,630 7,630 0.5 3,815 98 373,870 373,870
Sec. 484.105(h)................ 0938-New........... 14 14 1.5 21 98 2,058 2,058
Sec. 484.110(a)................ 0938-New........... 12,602 17,751,840 0.083 1,473,403 26 38,308,478 38,308,478
-------------------------------------------------------------------------------------------------
Total........................ ................... 140,189 40,135,877 19 4,462,805 1,185 182,350,264 182,350,264
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Denotes a one-time information collection requirement.

There are no capital/maintenance costs associated with the
information collection requirements contained in this rule; therefore,
we have removed the associated column from Table 2. In addition, the
column for the total costs is also represents the total cost of
reporting; therefore, we have removed the total cost of reporting
column from Table 2 as well.

VIII. 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 Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (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). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
This final rule is a revision of the Medicare and Medicaid CoPs for
HHAs. The CoPs are the basic health and safety requirements that an HHA
must meet in order to receive payment from the Medicare and Medicaid
programs. This final rule incorporates advances and current medical
practices in caring for home health patients while removing unnecessary
process and procedure requirements contained in the current CoPs. This
is a major rule because the overall economic impact for all of the new
CoPs is estimated to be $293.3 million in year 1 and $290.1 million in
year 2 and thereafter.

B. Statement of Need

As the single largest payer for health care services in the United
States, the federal government assumes a critical responsibility for
the delivery and quality of care furnished under its programs.
Historically, we have adopted a quality assurance approach that has
been directed toward identifying health care providers that furnish
poor quality care or fail to meet minimum federal standards, but this
problem-focused approach has inherent limits. Ensuring quality through
the enforcement of prescriptive health and safety standards, rather
than improving the quality of care for all patients, has resulted in
our expending much of our resources on dealing with marginal providers,
rather than on stimulating broad-based improvements in the quality of
care delivered to all patients.
This final rule adopts a new approach that focuses on the care
delivered to patients by home health agencies while allowing HHAs
greater flexibility and eliminating unnecessary procedural
requirements. As a result, we are revising the HHA requirements to
focus on a patient-centered, data-driven, outcome-oriented process that
promotes high quality patient care at all times for all patients. We
have developed a set of fundamental requirements for HHA services that
encompasses patient rights, comprehensive patient assessment, and
patient care planning and coordination by an interdisciplinary team.
Overarching these requirements is a QAPI program that builds on the
philosophy that a provider's own quality management system is key to
improved patient care performance.
These regulations contain two critical improvements that support
and extend our focus on patient-centered, outcome-oriented surveys.
First, the regulations are designed to enable surveyors to look at
outcomes of care, because the regulations specify that each individual
receives the care which his or her assessed needs demonstrate is
necessary, rather than focusing simply on the services and processes
that must be in place. Second, the addition of a strong QAPI
requirement not only stimulates the HHA to continuously monitor its
performance and find opportunities for improvement, it also affords the
surveyor the ability to assess how effectively the provider was
pursuing a continuous quality improvement agenda. All of the changes
are be directed toward improving patient-centered outcomes of care. We
believe that the overall approach of the final CoPs will increase
performance expectations for HHAs, in terms of achieving needed and
desired outcomes for patients and increasing patient satisfaction with
services provided.

C. Public Comments

As discussed in section III, ``Analysis of and Responses to Public
Comments,'' of this rule, we received several public comments related
to the estimates presented in the RIA section of the proposed rule. As
a general summation, commenters stated that the estimates did not fully
account for the burdens that HHAs will encounter in implementing this
rule. However, by and large, commenters did not provide suggestions for
estimates that should be used or evidence to guide the development of
new estimates. Responses to particular comments are included under the
relevant subject

[[Page 4570]]

matter headings. That is to say, comments regarding the RIA estimates
related to patient rights, for example, are located in the discussion
of all other patient rights comments. Those who submitted comments on
particular burden estimates made general, vague statements that the
estimates for the time and cost associated with compliance were
understated. With one exception, commenters did not provide suggestions
of more appropriate estimates. We received one specific comment, which
asserted that requiring HHAs to notify patients of their right to
access their own medical records would cost the HHA and additional
$230k, annually, because many more patients would be accessing their
records. However, notifying each patient of his right to receive a copy
of information contained in his medical record is already included in
the standard HIPAA notice that HHAs are required to provide (see 45 CFR
164.520, as accounted for by OMB Control Number 0945-0003). Therefore,
we are not creating a new right, nor are we creating a new notice of
this right. Thus, we do not believe that this requirement will create
the exponential increase in record requests that the commenter claims.

D. Summary of Impacts

Section VII of this rule, Collection of Information Requirements,
provides a detailed analysis of the burden hours and associated costs
for all burdens related to the collection of information by HHAs that
is required by this rule. That section, in tandem with this regulatory
impact analysis section, present a full account of the burdens that
will be imposed by this rule. Because the burdens have already been
assessed in the Collection of Information Requirements section, we will
not recount them in this RIA section. All estimates presented in this
RIA section are based on the assumptions presented in Table 1, located
at the beginning of the Section VII of this rule, Collection of
Information Requirements.
Although we endeavor to provide the most accurate account of the
burdens that will be imposed by this rule that is possible, we
acknowledge that such analysis is inevitably imprecise. We believe that
many of the tasks set forth in this final rule are already being done
by the majority of HHAs as part of good business and health care
practice. We have identified several activities, such as developing and
updating a written plan of care for each patient, as usual and
customary practices that would occur in the absence of regulation.
While we believe that these identifications are an accurate reflection
of current HHA practices as a whole, uncertainty remains regarding
whether such usual and customary practices occur in all HHAs in all
appropriate circumstances. Additionally, there are some estimates for
which we lack information regarding implementation in the HHA
environment because we have not previously regulated those activities.
Following implementation of this final rule, we will monitor HHA
practices to assess the impact of these new regulations.
Where appropriate, we have differentiated between the burdens that
this rule would impose on accredited versus non-accredited HHAs in
recognition of the fact that current accreditation standards
established by the three main HHA accreditation entities will meet or
exceed the minimum standards that are established in this rule.
Accredited HHAs will experience less burden when implementing new the
patient rights, QAPI, infection prevention and control, and
organization and administration of services requirements.
In addition to analyzing the burden hours and associated costs for
all burdens related to these requirements, we have also assessed the
potential savings associated with our removal of certain outdated,
burdensome requirements that exist in the current HHA CoPs.

Table 3--Summary of Estimated Burden for All CoPs
----------------------------------------------------------------------------------------------------------------
Annual cost in
CoP Total time Total cost in year 2 and
(hours) year 1 thereafter
----------------------------------------------------------------------------------------------------------------
Burden and Cost Estimates Associated with Information 4,462,805 $182,350,264 $179,136,942
Collection Requirements...............................
Patient rights......................................... 2,398,446 147,326,970 147,326,970
QAPI................................................... 618,030 29,070,300 25,316,340
Infection prevention and control....................... 595,140 37,493,820 37,493,820
Removal of 60 day summary requirement.................. 887,592 -16,864,248 -16,864,248
Removal of Group of professional personnel requirement. 203,620 -16,924,452 -16,924,452
Removal of Evaluation of the agency's program.......... 1,335,073 -69,111,119 -69,111,119
--------------------------------------------------------
Total.............................................. 5,648,136 293,341,535 290,128,213
----------------------------------------------------------------------------------------------------------------

1. Burden Assessment
Reporting OASIS Information (Sec. 484.45)
We are making one change to replace the requirement that an HHA has
a ``direct telephone connection'' to transmit the OASIS data with a
requirement that an HHA must transmit data using electronic
communications software that complies with the Federal Information
Processing Standard (FIPS 140-2, issued May 25, 2001) from the HHA or
the HHA contractor to the CMS collection site. The FIPS 140-2 applies
to all federal agencies that use cryptographic-based security systems
to protect sensitive information in computer and telecommunication
systems (including voice systems) as defined in section 5131 of the
Information Technology Management Reform Act of 1996, Public Law 104-
106, including CMS. Therefore, this requirement does not impose a new
burden upon HHAs.
Patient Rights (Sec. 484.50)
The final rule requires that an HHA must provide a patient with a
written notice of rights. The final rule requires that an HHA must
provide a patient's representative (legal) with a written notice of
rights, and must provide a patient's representative (patient-selected)
with a written notice of rights in accordance with patient preferences.
Communicating with patients and representatives, including the
provision of a written notice of rights, is a standard practice in the
health care industry and would impose no additional costs. Similar
requirements already exist for many other health care provider types,
including hospice providers, long term care facilities, ambulatory
surgery centers, and end-stage renal disease facilities.

[[Page 4571]]

Verbal notification of rights in a language and manner that the
individual understands, however, may create a new burden for some HHAs.
The national accrediting organizations already require their accredited
HHAs to orally apprise their patients of their rights in situations
where patients cannot read or understand the written notice. We assume,
for purposes of this analysis only, that accredited HHAs are providing
oral notification to the 25 percent of their patients that cannot read
or understand the written notice. Based on this assumption, 1,751,387
patients are already orally notified of their rights each year;
therefore, we are excluding these patients from this analysis. For the
remaining 75 percent of patients receiving care from an accredited HHA,
we estimate that it would take approximately 5 minutes per patient to
describe the content of the notice of rights and obtain the patient's
signature confirming that he or she has received a copy of the notice.
We assume that patients would be informed of their rights by a
registered nurse at a cost of $5 per patient (5 minutes x $63/hour).
The total number of hours per accredited HHA would be 88 hours (1,057
patients x 5 minutes per patient/60 minutes), at a cost of $5,285
(1,057 patients x $5 per patient).
For non-accredited HHAs, the requirement to provide this verbal
notice is a new requirement for all 1,409 patients served in an average
HHA each year. The total cost of this provision per non-accredited HHA
would be $7,045 (1,409 patients x $5 per patient). The total number of
hours per non-accredited HHA would be 117 hours (1,409 patients x 5
minutes per patient/60 minutes). The total cost for all HHAs would be
$80,030,370 ([$7,045 per non-accredited x 7,630 HHAs] + [$5,285 per
accredited HHA x 4,972 HHAs]). The total number of hours for all HHAs
would be 1,330,246 hours ([117 hours per non-accredited HHA x 7,630
HHAs] + [88 hours per non-accredited HHA x 4,972 HHAs]).
We note that the requirement to communicate with patients in a
language and manner that the patient understands is not a new
expectation for Medicare-approved HHAs, as they are already required to
be in compliance with the current civil rights requirements and
guidance (see 42 CFR 489.10(b)). Specifically, HHAs are already
required to comply with the requirements of Title VI of the Civil
Rights Act of 1964, section 504 of the Rehabilitation Act of 1973, the
Age Discrimination Act of 1975, section 1557 of the Affordable Care Act
and ``other pertinent requirements of the Office for Civil Rights of
HHS.'' HHS guidance, issued in 2003, further explains the expected role
of interpreters in communications with patients (``Guidance to Federal
Assistance Recipients Regarding Title VI Prohibition Against National
Origin Discrimination Affecting Limited English Proficient Persons,''
August 8, 2003, 68 FR 47311). As such, the requirement to communicate
with patients in a language and manner that the patient understands
would not impose a new burden on HHAs.
Standard 484.50(e) requires that all patient/family complaints be
investigated. We estimate that, in a 1 year period, an HHA would need
to investigate complaints involving about 5 percent (70) of its
patients, and that each investigation would take 2 hours to complete.
The total annual burden per HHA would be 140 hours (70 investigations x
2 hour per investigation). All national accrediting organizations
already require their accredited HHAs to document, investigate, and
resolve patient complaints; therefore all 4,972 accredited HHAs would
not be burdened by this requirement. The total annual burden hours for
the industry would be 1,068,200 (140 hours per HHA x 7,630 non-
accredited HHAs). The total annual cost for the QAPI coordinator to
complete all investigations would be $8,820 per HHA ($63/hour x 140
hours), and $67,296,600 for all non-accredited HHAs ($63/hour x
1,068,200 hours).

Table 4--Patient Rights
----------------------------------------------------------------------------------------------------------------
Time per HHA Total time
Standard (hours) (hours) Cost per HHA Total cost
----------------------------------------------------------------------------------------------------------------
Providing notice of rights (annual, non- 117/88 1,330,246 $7,045/5,285 $80,030,370
accredited/accredited HHAs)...............
Investigations (annual, non-accredited 140 1,068,200 $8,820 $67,296,600
HHAs).....................................
--------------------------------------------------------------------
Total (annual, non-accredited/ 257 or 88 2,398,446 $15,865 or $5,285 $147,326,970
accredited)...........................
----------------------------------------------------------------------------------------------------------------

Comprehensive Assessment of Patients (Sec. 484.55)
We are retaining the requirements of current Sec. 484.55, with a
reorganization of several sections related to the content of the
comprehensive assessment and the addition of several broad focus areas.
We believe that the new focus areas (for example, cognitive status and
patient goals) are standard practice and would not impose an additional
burden. In addition, we are making a minor change to allow for the
completion of an OASIS update upon the physician-ordered resumption of
care date. Allowing for a physician to order the resumption of care
date increases HHA flexibility; therefore there is no new burden
associated with this retention.
Care Planning, Coordination of Services, and Quality of Care (Sec.
484.60)
The current regulations at Sec. 484.12(c), ``Compliance with
accepted professional standards and principles''; Sec. 484.14(g),
``Coordination of patient services''; and Sec. 484.18 ``Acceptance of
patients, plan of care, and medical supervision,'' are reorganized and
revised at Sec. 484.60.
The change in Sec. 484.18, ``Acceptance of patients, plan of care,
and medical supervision,'' requires each patient to receive an
individualized written plan of care, including any additions or
revisions. The plan of care includes all orders, specifies the care and
services necessary to meet the patient-specific needs and the
measurable outcomes that the HHA anticipates would occur as a result of
implementing and coordinating the plan of care with the patient and
physician, and includes all patient and caregiver education and
training. The intent of the current standard at Sec. 484.12(c) is
retained under this CoP with the requirement that services be furnished
in accordance with accepted standards of practice. No burden is
associated with this part of the CoPs, as these requirements constitute
current industry practices regarding plans of care.
Standard 484.60(a), ``Plan of care,'' codifies current industry
standards of practice through the revision of current Sec. 484.18(a),
``Plan of care,'' including references to the identification of
patient-specific needs and measurable outcomes that are already
currently required under current Sec. 484.55,

[[Page 4572]]

``Comprehensive assessment of patients.'' Therefore, this requirement
does not present a new burden.
Proposed Sec. 484.60(b), ``Conformance with physician orders,''
retains the provision of the current regulation at 42 CFR 484.18(c)
that allows HHAs to administer influenza and pneumococcal vaccinations
without specific physician orders, provided that certain requirements
are adhered to. As an allowance of flexibility, rather than an
imposition of a specific requirement, we believe that this provision
does not impose a burden upon HHAs.
This standard also retains many of the current requirements
regarding verbal orders with the exception of the requirement at Sec.
484.60(b)(5), ``Conformance with physician orders,'' which requires the
physician to countersign and date all verbal orders. Although this
requirement is not in the current regulations, this and similar
physician order practices are consistent with current standards of
practice and with many state laws. Therefore, we expect no new burden
with this provision.
Standard 484.60(c), ``Review and revision of the plan of care,''
incorporates some current requirements. Although there has been some
revision to current Sec. 484.18(b), ``Periodic review of plan of
care,'' to include mention of measurable outcomes for patients, the
intent of this requirement already exists at Sec. 484.55,
``Comprehensive assessment of patients.'' Section 484.55 requires an
HHA to demonstrate patient progress toward the achievement of desired
outcomes. Therefore, the current standard remains essentially intact in
this final rule and the new standard does not constitute any new
burden.
Standard 484.60(d), ``Coordination of care,'' revises current Sec.
484.14(g), ``Coordination of patient services,'' and some elements of
current Sec. 484.18(a), ``Plan of care.'' The intent of the current
standards remains intact, and these revisions do not generate new
burden.
Standard 484.60(e), ``Written information to the patient,''
requires the HHA to provide written instructions to the patient and
care giver outlining visit schedule including frequency of visits,
medication schedule/instructions, treatments administered by HHA
personnel and personnel acting on the behalf of the HHA, pertinent
instructions related to patient care and the name and contact
information of the HHA clinical manager. Giving written instruction to
the patient and care giver has been a longstanding practice in the home
health industry and is one of the most fundamental elements in patient
education. Patient education practices are fundamental to patient care
and are consistent with current standards of practice. Therefore, we
expect no new burden with this provision.
Quality Assessment and Performance Improvement (QAPI) (Sec. 484.65)
The quality assessment and performance improvement (QAPI)
requirement replaces the current quality-related requirements of Sec.
484.16, ``Group of professional personnel,'' and Sec. 484.52,
``Evaluation of the agency's program.'' Quality assessment is already
part of standard HHA practice through annual evaluations of an agency's
total program using both administrative reviews and a quarterly review
of a sample of clinical records. Furthermore, HHAs are already familiar
with the basic concept of measuring quality on both a patient and
aggregate level. This rule further refines current HHA quality efforts
and brings HHA quality programs in line with their counterparts in a
variety of other settings, such as hospitals and hospices. Likewise,
this rule brings non-accredited HHA quality practices in line with
those of their accredited counterparts. The national accrediting
organizations have spent a decade or more enhancing, expanding, and
refining their quality-related standards, and those standards far
exceed the current Medicare regulations. Indeed, many of the current
quality-related standards established by the accrediting organizations,
we believe, exceed those that we require in this rule. Since accredited
HHAs already have QAPI programs that should meet the requirements of
this rule by virtue of meeting the already existing accreditation
standards, we are not including accredited HHAs in our analysis of the
impact of this requirement. This rule provides a basic outline of what
QAPI is and how we expect it to function in the HHA environment. Each
HHA is free to decide how to implement the QAPI requirement in a manner
that reflects its own unique needs and goals.
For purposes of this impact analysis we have described the impact
in three general phases that we believe an average HHA will go through.
These phases are based on our experience in implementing the QAPI
requirements in hospices, another home-based provider type with a
similar operating structure and patient population. While we have
outlined these phases below, we stress that an HHA is not be required
to approach QAPI in this manner. The QAPI requirement does not
stipulate that an HHA must collect data for a specific domain; use
specific quality measures, policies and procedures, or forms; submit
QAPI data to an outside body; or conduct a specified number of
performance improvement projects. An HHA may choose to implement a
data-driven, comprehensive QAPI program that meets the requirements of
this rule in any way that meets its individual needs. These phases
described below simply provide a framework for assessing the potential
impact of the QAPI requirement upon an average non-accredited HHA. In
phase one, we believe that an HHA will--
Identify quality domains and measurements that reflect its
organizational complexity; involve all HHA services; affect patient
outcomes, patient safety, and quality of care; focus on high risk, high
volume, or problem-prone areas; and track adverse patient events;
Develop and revise policies and procedures to ensure that
data is consistently collected, documented, retrieved, and analyzed in
an accurate manner; and
Educate HHA employees and contractors about the QAPI
requirement, philosophy, policies, and procedures. In phase two, we
believe that an HHA will--
Enter data into patient clinical records during patient
assessments;
Aggregate data by collecting the same pieces of data from
patient clinical records and other sources (for example, human resource
records);
Analyze the data that is aggregated through charts,
graphs, and various other methods to identify patterns, anomalies,
areas of concern, etc. that may be useful in targeting areas for
improvement; and
Develop, implement, and evaluate major and minor
performance improvement projects based on a thorough analysis of the
data collected. In phase three, we believe that an HHA will--
Identify new domains and measures that may replace or be
in addition to the domains and measures already being monitored by the
HHA;
Develop and/or revise policies and procedures to
accommodate the new domains and measures; and
Educate HHA employees and contractors on the new domains
and measures, as well as the policies and procedures for them.
In addition to these three phases, an HHA will likely allocate
resources to an individual responsible for the general overall
coordination of its QAPI program. For simplicity, we refer to this
individual as the QAPI coordinator; however, an HHA is not required to
use this title. For purposes of this analysis only, we assume that an
HHA would

[[Page 4573]]

choose a QAPI coordinator who has a clinical background, such as a
nurse.
Based on these three phases, we have anticipated the impact of the
QAPI requirement on an HHA's resources. In phase one, we anticipate
that an HHA will use 9 hours to identify quality domains and measures.
HHA quality domains and measures are readily available. Indeed, HHAs
already collect data for a wide variety of domains and measures each
year as part of the OASIS patient assessment data collection tool, and
this data is already used to calculate quality measures as presented in
OBQI, OBQM, and PBQI reports and the home health compare Web site.
These sources provide a robust starting point for HHAs in the quality
measurement efforts. We expect that these hours will be distributed
among the three members of the HHA's QAPI committee. While we do not
require an HHA to have a QAPI committee, we believe that most HHAs
would choose to do so to ensure a variety of perspectives are
represented in the QAPI decision-making process. We believe that the
QAPI committee will include the QAPI coordinator, the HHA
administrator, and a clinical manager. We estimate that the QAPI
committee will meet three times per year for 1 hour each meeting to
identify appropriate quality domains and measures. We estimate that, in
total, the QAPI committee will need 9 hours annually to identify
appropriate quality domains and measures (3 staff hours per meeting x 3
meetings per year). The total annual cost for an average HHA to
identify the domains and measures is $738 ($189 per QAPI coordinator +
$294 per administrator + $255 per clinical manager). The total cost for
all HHAs is $5,630,940 ($738 per HHA x 7,630 non-accredited HHAs).
In addition to selecting measures and developing policies and
procedures for QAPI activities, we anticipate that HHAs will train
appropriate staff in data collection for any new data elements
necessary to calculate quality measures, as well as the overall QAPI
philosophy and efforts within the agency. For purposes of this
analysis, we assume HHAs will train all clinical staff in the basic
concept of QAPI, the agency's implementation of this requirement, and
any agency-specific policies and procedures. We estimate that an HHA
will spend 1 hour per staff member to provide this training, as many
staff are already familiar with data collection and its role in quality
measurement and improvement through the OASIS, OBQI, and PBQI
instruments. For purposes of our analysis we are including patient care
clinicians because they are the staff members that are most likely to
be performing data collection. In 2009, Medicare-certified HHAs had
242,020 clinician FTEs, for an average of 24 clinical FTEs per HHA. The
cost per HHA is $1,824. (1 hour per clinical staff member x 24 clinical
staff members x $76 per hour per clinical staff member) The total hour
for non-accredited HHAs is 183,120 (24 hours per average HHA x 7,630
non-accredited HHAs) and the total cost is $13,917,120 (183,120 hours x
$76/hour).
Phase two is related to gathering, entering, and analyzing data for
quality assessment and performance improvement purposes. Thoroughly
assessing a patient and collecting patient data in a standardized
manner is already standard practice due to the OASIS regulations. The
presence of the OASIS data set and quality reporting measures has been
in place for several years and the concepts of each are fully
integrated into standard HHA practices. Therefore, we do not believe
that it would be a burden for HHAs to incorporate new data gathered for
dual patient care planning and QAPI purposes into their current systems
and processes.
We believe that any additional burden will arise from the act of
entering, aggregating, and analyzing other types of available data that
HHAs already collect for other purposes (for example, staffing
productivity, staff vacancy rates, timeliness of delivery of services).
We estimate that, in order to ensure that the volume of gathered data
is manageable, an HHA will gather its data once a month. An HHA may
choose to gather data on a more or less frequent basis to suit its
needs and circumstances. Some HHAs may choose to gather all patient-
level data, but we believe that most HHAs will choose to gather data
from a sample of clinical records. Likewise, some HHAs may choose to
gather data from a wide variety of administrative files, while others
may choose to select only a few administrative data sources. There are
many combinations that an HHA may choose to use when it comes to
gathering data, and no single approach is considered preferable to
another. Given this variability, it is difficult to estimate how long
an average HHA may spend gathering and organizing data. For purposes of
this analysis only, we assume that an average HHA will use 4 hours per
month to gather data, for a total of 48 hours a year. We believe that
an office employee would perform the data aggregation and organization
at a cost of $1,248 (4 hours x 12 months x $26/hour) per HHA. The total
cost is $9,522,240 ($1,248 per HHA x 7,630 HHAs). Following data
gathering and organization, an HHA will analyze the data to identify
trends, patterns, anomalies, areas of strength and concern. We believe
that this data analysis will be done by the QAPI committee described
previously. In order to identify trends and patterns, the committee
will need to examine several months of data at the same time.
Therefore, we assume that the committee will meet once every quarter to
examine the data and make decisions based on the analysis. Meeting to
discuss quality measure data is standard practice in the HHA industry.
HHAs are well versed in quality measure reports due to the OBQI and
PBQI reports produced by CMS, and the quality measure reports available
to the public on the Home Health Compare Web site. Since HHAs already
meet to discuss and analyze quality measure results, we do not believe
that this requirement will impose a new burden.
Performance improvement projects follow all of the data entry,
gathering, organization, and analysis. An HHA must conduct projects to
improve its performance in areas where a weakness was identified.
Performance improvement projects must reflect the HHA's scope,
complexity, and past performance. They must also be data-driven, and
affect patient outcomes, patient safety, and quality of care. Although
this rule more clearly describes a performance improvement project, its
basis, and its purpose, it is based on the same concept as the current
requirement at Sec. 484.52, ``Evaluation of the agency's program,''
which requires that ``Results of the evaluation are reported and acted
upon by those responsible for the operation of the agency. . . .''
Since an HHA already takes action to ensure that its program is
appropriate, adequate, effective, and efficient, and since providing
safe and effective care at all times for all patients is the essential
charge of all health care providers, we believe that conducting both
major and minor performance improvement projects is already a standard
of practice within the HHA industry. Therefore, there will be no
additional burden associated with this provision. Although we do not
believe that the requirement to conduct performance improvement
projects will require additional time and resources, we do believe that
the required focus of such projects, and their data-driven nature, will
help HHAs improve the efficiency and effectiveness that they achieve in
these projects. We believe that the improved project efficiency and
effectiveness may result in improved patient outcomes,

[[Page 4574]]

avoidance of future adverse events, more appropriate resource
allocation, and a wide variety of other beneficial outcomes, based on
the projects selected by each HHA.
Phase three of the QAPI process builds upon the QAPI program that
an HHA already has in place. We estimate that an HHA will use 3 hours a
year to identify new domains and quality measures, and we believe that
the QAPI committee will perform this task, at a total cost of $246 (1
hour x $63/hour for QAPI coordinator + 1 hour x $98/hour for
administrator + 1 hour x $85/hour rate for clinical manager). The total
annual cost for non-accredited HHAs in updating domain and measures is
$1,876,980 ($246 per HHA x 7,630 HHAs) in year 2 and thereafter.

Table 5--Quality Assessment and Performance Improvement
----------------------------------------------------------------------------------------------------------------
Time per HHA Total time
Standard (hours) (hours) Cost per HHA Total cost
----------------------------------------------------------------------------------------------------------------
Identify domains and measures (1st year)........ 9 68,670 $738 $5,630,940
Train staff (1st year and on-going)............. 24 183,120 1,824 13,917,120
Aggregate data (1st year and on-going).......... 48 366,240 1,248 9,522,240
Update domains and measures (on-going).......... 3 22,890 246 1,876,980
---------------------------------------------------------------
Total 1st year.............................. 81 618,030 3,810 29,070,300
===============================================================
Total yearly on-going................... 75 572,250 3,318 25,316,340
----------------------------------------------------------------------------------------------------------------

Infection Prevention and Control (Sec. 484.70)
There is no specific current requirement addressing infection
control in the current HHA CoPs. However, current Sec. 484.12(c),
``Compliance with accepted professional standards and principles,''
requires an HHA and its staff to comply with accepted professional
standards and principles that apply to professionals furnishing
services in an HHA. Given this broad requirement, we believe that HHA
personnel are already using well-documented infection control practices
and well-accepted professional standards and principles in their
patient care practices. This regulation reinforces positive infection
control practices and addresses the serious nature, as well as the
potential hazards, of infectious and communicable diseases in the home
health environment. This rule also brings non-accredited HHA quality
practices in line with those of their accredited counterparts. The
national accrediting organizations have spent a decade or more
developing and refining their infection prevention and control
standards in the absence of specific Medicare regulations. Indeed, the
current infection prevention and control standards established by the
accrediting organizations would, we believe, even exceed those that we
require in this rule.
Specifically, the regulation requires HHAs to have an organized,
agency-wide program for the surveillance, identification, prevention,
control, and investigation of infectious and communicable diseases that
is an integral part of the HHA's quality assessment and performance
improvement (QAPI) program. The agency's program is required to include
the following:
The use of accepted standards of practice, including
standard precautions, to prevent the transmission of infections and
communicable diseases;
A method for identifying infectious and communicable
disease problems;
A plan for the appropriate actions that are expected to
result in improvement and disease prevention; and
Education to staff, patients, and caregivers about
infection prevention and control issued and practices.
We believe that developing this organized program will require HHA
resources, and estimate that an HHA will use 1.5 hours of staff time
each week, or 78 hours per year (1.5 hours x 52 weeks), to develop and
maintain the infection prevention and control program. At a cost of $63
per hour for a nurse to provide program leadership, the cost will be
$4,914 per HHA (78 hours x $63/hour)
While we cannot quantify the benefits of having an organized
program for the prevention and control of infections or the costs of
replacing current infection control practices with practices conducted
under an organized program, we believe a program should produce
benefits for HHAs and their patients. For example, a program may
improve the manner in which HHAs identify to HHA staff those patients
who are infected or colonized with antibiotic resistant bacteria so
that staff may take additional precautions in order to protect
themselves during interactions with patients, thereby reducing the
amount of sick leave used by HHA staff. We do not have adequate data
from which to create accurate estimates of the potential benefits or
ongoing costs of this requirement, but we believe that they are
substantial.

Table 6--Infection Prevention and Control
----------------------------------------------------------------------------------------------------------------
Time per HHA Total time
Standard (hours) (hours) Cost per HHA Total cost
----------------------------------------------------------------------------------------------------------------
Develop and maintain program.................... 78 595,140 $4,914 $37,493,820
---------------------------------------------------------------
Total....................................... 78 595,140 4,914 37,493,820
----------------------------------------------------------------------------------------------------------------

Skilled Professional Services (Sec. 484.75)
We consolidated provisions previously located at Sec. 484.30,
``Skilled nursing services''; Sec. 484.32, ``Therapy services''; and
Sec. 484.34, ``Medical social services,'' into this new requirement.
We added a requirement that skilled professionals participate in the
QAPI program. Involvement in patient care and patient care-related
activities is a professional responsibility, and therefore we believe
involvement in the

[[Page 4575]]

agency's QAPI program imposes little or no additional burden. We also
added a requirement, somewhat similar to the requirement at Sec.
484.14(d), regarding the supervision of nursing assistants, therapy
assistants, and medical social service assistants. We require that all
nursing services be provided under the supervision of a registered
nurse; all rehabilitative therapy assistant services be provided under
the supervision of a physical therapist or occupational therapist; and
all medical social services be provided under the supervision of a
social worker. These supervision requirements codify current HHA
supervision practices, and therefore do not impose a new burden upon
HHAs.
Home Health Aide Services (Sec. 484.80)
Home health aide services are an integral part of home health care,
and the CoP retains many of the current longstanding requirements.
However, in an effort to make the current requirements for home health
aides more consistent throughout, improve overall clarity, and reflect
current standards of practice more accurately, we have reorganized and
revised the requirements in this CoP. The burdens associated with this
section are described in the Collection of Information section of this
rule. Therefore, we are not repeating those burdens in this section.
Other changes, such as requiring HHAs to supervise aides when
performing skills for which the aides have not passed a competency
evaluation or requiring aides to report changes in a patient's
condition to a registered nurse or other appropriate skilled
professional, constitute standard practice within the HHA industry.
Therefore, no new burdens are imposed by these changes.
Compliance With Federal, State, and Local Laws and Regulations Related
to Health and Safety of Patients (Sec. 484.100)
The current regulations at Sec. 484.12(a), ``Compliance with
Federal, State, and local laws and regulations''; Sec. 484.12(b),
``Disclosure of ownership and management information''; and Sec.
484.14(j), ``Laboratory services,'' have been reorganized with only
minor clarifying revisions to the language of each standard. The
current condition statement is modified slightly for clarification
purposes. However, the current regulation regarding compliance with all
applicable laws and regulations related to patient health and safety,
state licensing of HHAs, and laboratory services, essentially remains
intact under this rule. The burden associated with this provision is
the disclosure of certain information, which was discussed in the
Collection of Information section of this rule, and there are no other
burdens associated with this provision.
Organization and Administration of Services (Sec. 484.105)
Several of the requirements currently found at Sec. 484.14,
``Organization, services, and administration,'' have been reorganized
and revised under this condition.
In order to facilitate compliance with Sec. 484.60(d) and to
ensure that each patient's care is coordinated, we have combined,
revised, and elaborated on former Sec. 484.14(d) and (e) at Sec.
484.105(c), ``Clinical manager.'' This standard requires one or more
qualified individuals to provide oversight of all patient care services
and HHA personnel. Oversight includes making patient and personnel
assignments; coordinating patient care; coordinating referrals; and
assuring the development, implementation, and updates of the
individualized plan of care. The clinical manager role in the
regulations is a further refinement of the former ``Supervising
physician or registered nurse'' role found in regulation at Sec.
418.14(d); therefore the general duties described above are already
required of home health agencies. The complex, multi-disciplinary
nature of home health care necessitates both personnel supervision and
patient care coordination to ensure the effective delivery of patient
care and positive patient outcomes. The clinical manager position does
not constitute any new functions within an HHA; rather, it provides a
more structured approach for patient care coordination and personnel
supervision tasks. Since the various patient care coordination
functions already in existence are consolidated under the clinical
manager position and are thus be a realignment of current resource
allocations, we do not believe that this requirement poses a new
burden.
Clinical Records (Sec. 484.110)
The former regulation at Sec. 484.48, ``Clinical records,'' is
revised, and reorganized under this CoP. We believe that the majority
of the revisions to the former clinical record requirement reflect
contemporary professional standards already in place in the home health
industry. Therefore, no additional burden is imposed. In addition, the
requirements allow HHAs to maintain and send a patient's clinical
record in electronic form. This flexibility may result in a reduction
in burden for many HHAs with systems of electronic record keeping
already in place.
Personnel Qualifications (Sec. 484.115)
We reorganized the personnel qualification requirements formerly
found at Sec. 484.4, ``Personnel qualifications,'' in a new CoP
dedicated to personnel qualification standards. Within this new
condition we use the term ``licensed practical (vocational) nurse''
instead of the current term of ``practical (vocational) nurse'' since
state practice acts vary and both of these terms are accepted and
typically used interchangeably We also require that the possession of
any undergraduate degree would be sufficient for a newly-hired
administrator. In addition, we are expanding the qualifications for
social workers to include those individuals who possess either a
master's (M.S.W) or a doctor's degree (D.S.W.) in social work.
Furthermore, we are deferring to state licensure requirements as the
basis for determining the qualifications of SLPs. This expansion of the
qualifications for administrators, social workers, and SLPs could
provide an agency more flexibility in hiring these professions if it
chose, and could provide a potential reduction in burden, though we are
not able to quantify what this reduction might be at this time. These
changes create no new burden for HHAs.
2. Deleted Requirements
We deleted three requirements of the former HHA regulations in
their entirety. First, we deleted Sec. 484.14(g), removing the
requirement that an HHA must send a written summary report for each
patient to the attending physician every 60 days. This requirement
imposes a burden of 3 minutes per patient, and 887,592 hours, annually,
for all HHAs at a cost of $16,864,248, as indicated by the currently-
approved PRA package (OMB control number 0938-0365). Therefore,
removing this requirement saves HHAs $16,864,248 each year.
Second, we deleted Sec. 484.16, ``Group of professional
personnel,'' because the QAPI requirements address the same goals as
are currently required of the group of professional personnel. This
requirement imposes a documentation burden of 10 minutes per HHA, and
1,988 hours, annually, for all HHAs at a cost of $37,772, as indicated
by the currently-approved PRA package (OMB control number 0938-0365).
In addition to the burden related to documentation, we believe that
eliminating this requirement also alleviates the burden of holding
meetings with the group of professional

[[Page 4576]]

personnel for the sole purpose of complying with this regulatory
requirement. The regulation requires that the group must consist of at
least one physician, one registered nurse, and representation from
other professional disciplines, with at least one member who is not
employed by or an owner of the HHA. Since the regulations at Sec.
484.14(a) require HHAs to provide skilled nursing services as well as
the services of at least one other discipline, not including physician
services, we know that the group of professional personnel is required
to have at least three members. For purposes of this analysis, we
assume that the group of professional personnel would include a
physician ($180), a registered nurse ($63), a therapist ($72), and a
home health aide ($20). The regulation also requires that the group of
professional personnel must meet ``frequently.'' For purposes of this
analysis, we assume that the frequency requirement would be met by
holding quarterly meetings of the group. Furthermore, we assume that
most quarterly meetings would require 1 hour of each member's time, for
a total of 4 labor hours per meeting, or 16 labor hours per year per
HHA. We estimate the cost associated with this requirement to be $335
per meeting, or $1,340 per HHA per year ($335 per meeting x 4 meetings
per year), for a total of 201,632 hours (16 hours per HHA x 12,602
HHAs) at cost of $16,886,680 ($1,340 per HHA x 12,602 HHAs) per year.
Therefore, we estimate that the total reduction of burden is 203,620
hours (201,632 hours + 1,988 hours) and $16,924,452 ($16,886,680 +
$37,772).
Third, we deleted Sec. 484.52, ``Evaluation of the agency's
program,'' because the prescriptive quarterly review of clinical
records is outdated and unnecessary. This requirement currently imposes
a documentation burden of 11,863 hours, annually, for all HHAs at a
cost of $304,199, as indicated by the currently-approved PRA package
(OMB control number 0938-0365).
In addition to the documentation burden imposed by this
requirement, we believe that there is a burden associated with the time
necessary to complete the quarterly clinical record reviews. The
regulation requires that appropriate health professionals, representing
at least the scope of the program, review a sample of both active and
closed clinical records to determine whether established policies are
followed in furnishing services directly or under arrangement. There is
a continuing review of clinical records for each 60-day period that a
patient receives home health services to determine adequacy of the plan
of care and appropriateness of continuation of care. Each professional
may review the records separately, at different times. For purposes of
this analysis, we assume that an HHA would review a 5 percent sample of
its clinical records, or an average of 70 clinical records per year per
facility. Furthermore, for purposes of this analysis, we assume that a
registered nurse ($63/hour), a therapist ($72/hour), and a home health
aide ($20/hour) reviews each clinical record, and that each review
would require 30 minutes per discipline, for a total of 90 minutes per
record review. We estimate that each HHA uses 105 hours per year to
meet this requirement, for a total of 1,323,210 hours for all HHAs. The
total cost per record review is $78, or $5,460 per HHA per year, for a
total of $68,806,920 for all HHAs. Therefore, we believe that removing
this requirement alleviates a total burden of 1,335,073 hours and
$69,111,119.
3. Impact on Patient Care
Although the positive effects of these changes cannot be
quantified, we note that the changes are focused on improving the
delivery of care to each and every patient. For example, the QAPI
standard encourages HHAs to use their own internally-generated data to
proactively identify patient care inefficiencies, contradictions,
lapses, and other issues in the care delivery system so that HHAs can
rapidly implement performance improvement projects designed to remedy
the issue(s) at hand. Proactively identifying care issues and
implementing projects to correct those issues will ultimately lead to
more effective and efficient patient care and improved patient
outcomes. However, as previously indicated, we cannot quantify the
impact on patients.

E. Alternatives Considered

We considered finalizing the proposed requirement that HHAs must
proactively provide each patient with a copy of his or her plan of
care. We considered multiple options for implementing the originally
proposed requirement.
Option 1--Require HHAs to provide each patient with a copy of only
the initial plan of care. No written updates would be required in this
option. We estimate that this requirement would create approximately
600,000 annual burden hours, at a cost of $15.6 million, annually.
Option 2--Require HHAs to provide each patient with a copy of only
the initial plan of care, and require HHAs to translate key elements of
the plan of care into layman's terms. No written updates would be
required. We estimate that this requirement would create approximately
3 million annual burden hours at a cost of $189 million annually (based
on the assumption of a nurse using 10 minutes to translate the clinical
plan of care into layman's terms).
Option 3--Require HHAs to provide each patient with a copy of plan
of care for each 60-day episode of care. We estimate that this
requirement would create approximately 11 million annual burden hours
at a cost of $285 million, annually.
Option 4--Require HHAs to provide each patient with a copy of plan
of care and translate key elements of the plan of care into layman's
terms for each 60-day episode of care. We estimate that this
requirement would create approximately 55 million annual burden hours
at a cost of $3.5 billion, annually.
Option 5--Require HHAs to provide each patient with a copy of plan
of care and require it to be updated for significant changes. Assuming
4 plans of care per 60 day episode for complex patients and 1 plan of
care per 60 day episode for non-complex patients, we estimate that this
requirement would create approximately 31 million annual burden hours
at a cost of $799 million, annually.
Option 6--Require HHAs to provide each patient with a copy of plan
of care and translate key elements into layman's terms. Also require
the plan of care to be updated for significant changes. Assuming 4
plans of care per 60 day episode for complex patients and 1 plan of
care per 60 day episode for non-complex patients, we estimate that this
requirement would create approximately 153.6 million annual burden
hours at a cost of $9.7 billion, annually.
Option 7--Do not require HHAs to provide patients with written
information regarding the plan of care under any circumstances.
Removing this concept from the regulations entirely would be consistent
with current requirements, and would signal to HHAs, states, and
accreditation organizations that such written communication is
unnecessary. We believe that most HHAs are already providing certain
written information to patients. Removing this concept from the rules
entirely may encourage those entities to stop providing such written
information, thus reducing their self-imposed burden.
We also considered retaining the broad requirement from the
proposed rule that HHAs provide patients with the names, addresses, and
telephone

[[Page 4577]]

numbers of pertinent, Federally-funded and State-funded, State and
local consumer information, consumer protection, and advocacy agencies.
Commenters stated that such a broad requirement would impose a
significant burden due to the volume of entities to be identified and
the need to assure updated contact information for such entities at all
times. Although commenters did not provide an estimate of the burden,
we believe that HHAs may have expended one hour per quarter, or
approximately 50,000 hours annually at a cost of $1.3 million,
annually.

F. Accounting Statement

As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars_a004_a-4), we have prepared an
accounting statement in Table 7 showing the classification of the
transfers and costs associated with the provisions of this rule for
Calendar Year (CY) 2017 to 2021.

Table 7--Accounting Statement: Classification of Estimated Net Costs From CY 2017 to CY 2021
[In millions]
----------------------------------------------------------------------------------------------------------------
Units
-----------------------------------------------
Category Estimates Discount rate
Year dollar (%) Period covered
----------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized ($million/year)............ 291 2015 7 2017-2021
291 2015 3 2017-2021
----------------------------------------------------------------------------------------------------------------

Although the benefits and some of the costs of these changes cannot
be quantified, we note that the changes are focused on improving the
delivery of care to each and every patient. An increased focus on
identifying and proactively addressing risk factors for emergency
department visits and hospital re-admissions has the potential to
reduce both, leading to improved patient health and decreased payer
expenditures. Likewise, requiring HHAs to educate and teach patients
the necessary self-care skills to facilitate a timely discharge may
lead to more and better patient engagement in managing chronic health
conditions such as diabetes, ultimately leading to improved patient
health and reduced payer expenditures. However, as previously
indicated, we cannot quantify the impact on patients.

G. Regulatory Flexibility Act (RFA)

The RFA requires agencies to analyze options for regulatory relief
of small businesses, 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
government agencies. Individuals and states are not included in the
definition of a small entity. For the purposes of the RFA, most HHAs
are considered to be small entities, either by virtue of their
nonprofit status or government status, or by having revenues less than
$15 million in any 1 year (for details, see the Small Business
Administration's (SBA) Web site at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf (refer to the 620000 series).
There are 12,602 Medicare-certified HHAs with average annual patient
census of 1,409 patients per HHA. An average Medicare-participating HHA
in 2010 had annual revenues (all payment sources) of $6.55 million.
Therefore, the vast majority of these Medicare-certified HHAs would be
considered small entities under the SBA's NAICS.
As its measure of significant economic impact on a substantial
number of small entities, HHS uses a change in revenue of more than 3
to 5 percent. We do not believe that this threshold will be reached by
the requirements in this final rule because the cost of this rule on a
per-HHA basis is minimal (approximately a $15,100 net increase in
burden per typical non-accredited HHA in the 1st year, and a small net
savings of approximately $700 for accredited HHAs in the 1st year).
There are a small number of HHAs that will experience a larger increase
in burden than a typical HHA, ranging anywhere from an additional $500
to $59,000 per year, depending on which aspects of the rule constitute
a significant departure from their current practices. We believe that
these HHAs account for up to 10 percent of the entire HHA population.
An HHA tht would need to come into compliance with the most costly
provision (providing specified written information to patients per the
requirements of 484.60(e), approximately $59,000 per affected HHA)
would still only experience a change in revenue equal to 1.13 percent
($15,100+ $59,000). Therefore, we certify that this rule would not have
a significant economic impact on a substantial number of small
entities.
In addition, section 1102(b) of the Social Security Act requires us
to prepare a regulatory impact analysis if a rule may have a
significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 604 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a metropolitan statistical area and has fewer than 100 beds. We believe
that this rule would not have a significant impact on the operations of
a substantial number of small rural hospitals because there are few
HHAs in those facilities. Therefore, the Secretary has determined that
this final rule will not have a significant impact on the operations of
a substantial number of small rural hospitals.

H. Unfunded Mandates Reform Act (UMRA)

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 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2016, that
is approximately $146 million. It includes no mandates on state, local,
or tribal governments. The estimates presented in this section of the
final rule exceed this threshold and, as a result, we have provided a
detailed assessment of the anticipated costs and benefits in RIA
section as well as other parts of the preamble.

I. Federalism

Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct

[[Page 4578]]

requirement costs on state and local governments, preempts state law,
or otherwise has Federalism implications. This rule has no Federalism
implications.

J. Congressional Review Act

This regulation is subject to the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress
and the Comptroller General for review.
In accordance with the provisions of Executive Order 12866, this
final rule was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 409

Health facilities, Medicare.

42 CFR Part 410

Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural
areas, X-rays.

42 CFR Part 418

Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 440

Grant programs--health, Medicaid.

42 CFR Part 484

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

42 CFR Part 485

Grant programs--health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements.

42 CFR Part 488

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

For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 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. In the table below, for each section and paragraph indicated in the
first two columns, remove the reference indicated in the third column
and add the reference indicated in the fourth column:

----------------------------------------------------------------------------------------------------------------
Section Paragraphs Remove Add
----------------------------------------------------------------------------------------------------------------
Sec. 409.43...................... (a)................... Sec. 484.18(a)...... Sec. 484.60(a)
Sec. 409.43...................... (c)(1)(i)(C).......... 42 CFR 484.4.......... 42 CFR 484.115
Sec. 409.43...................... (d)................... Sec. 484.4.......... Sec. 484.115
Sec. 409.44...................... (b)(1) introductory Sec. 484.4.......... Sec. 484.115
text and (c)(2)(ii).
Sec. 409.45...................... (c)(4)................ Sec. 484.4.......... Sec. 484.115
Sec. 409.46...................... (b)................... Sec. 484.36(d)...... Sec. 484.80(h)
Sec. 409.47...................... (b) introductory text. Sec. 484.14(h)...... Sec. 484.105(e)
----------------------------------------------------------------------------------------------------------------

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
3. The authority citation for part 410 continues to read as follows:

Authority: Secs. 1102, 1834, 1871, 1881, and 1893 of the Social
Security Act (42 U.S.C. 1302. 1395m, 1395hh, and 1395ddd.

Sec. 410.62 [Amended]

0
4. In Sec. 410.62(a) introductory text, remove ``Sec. 484.4'' and add
in its place ``Sec. 484.115''.

PART 418--HOSPICE CARE

0
5. The authority citation for part 418 continues to read as follows:

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

0
6. In the table below, for each section and paragraph indicated in the
first two columns, remove the reference indicated in the third column
and add the reference indicated in the fourth column:

PART 440--SERVICES: GENERAL PROVISIONS

0
7. The authority citation for part 440 continues to read as follows:

Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).

Sec. 440.110 [Amended]

0
8. In Sec. 440.110(a)(2) and (b)(2), remove ``Sec. 484.4'' and add in
its place ``Sec. 484.115''.

PART 484--HOME HEALTH SERVICES

0
9. 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
10. Part 484 is amended by revising subparts A through C to read as
follows:
Subpart A--General Provisions
Sec.
484.1 Basis and scope.
484.2 Definitions.
Subpart B--Patient Care
484.40 Condition of participation: Release of patient identifiable
OASIS information.
484.45 Condition of participation: Reporting OASIS information.
484.50 Condition of participation: Patient rights.
484.55 Condition of participation: Comprehensive assessment of
patients.
484.60 Condition of participation: Care planning, coordination of
services, and quality of care.
484.65 Condition of participation: Quality assessment and
performance improvement (QAPI).
484.70 Condition of participation: Infection prevention and control.
484.75 Condition of participation: Skilled professional services.
484.80 Condition of participation: Home health aide services.

[[Page 4579]]

Subpart C--Organizational Environment
484.100 Condition of participation: Compliance with Federal, State,
and local laws and regulations related to health and safety of
patients.
484.102 Condition of participation: Emergency preparedness.
484.105 Condition of participation: Organization and administration
of services.
484.110 Condition of participation: Clinical records.
484.115 Condition of participation: Personnel qualifications.

Subpart A--General Provisions

Sec. 484.1 Basis and scope.

(a) Basis. This part is based on:
(1) Sections 1861(o) and 1891 of the Act, which establish the
conditions that an HHA must meet in order to participate in the
Medicare program and which, along with the additional requirements set
forth in this part, are considered necessary to ensure the health and
safety of patients; and
(2) Section 1861(z) of the Act, which specifies the institutional
planning standards that HHAs must meet.
(b) Scope. The provisions of this part serve as the basis for
survey activities for the purpose of determining whether an agency
meets the requirements for participation in the Medicare program.

Sec. 484.2 Definitions.

As used in subparts A, B, and C, of this part--
Branch office means an approved location or site from which a home
health agency provides services within a portion of the total
geographic area served by the parent agency. The parent home health
agency must provide supervision and administrative control of any
branch office. It is unnecessary for the branch office to independently
meet the conditions of participation as a home health agency.
Clinical note means a notation of a contact with a patient that is
written, timed, and dated, and which describes signs and symptoms,
treatment, drugs administered and the patient's reaction or response,
and any changes in physical or emotional condition during a given
period of time.
In advance means that HHA staff must complete the task prior to
performing any hands-on care or any patient education.
Parent home health agency means the agency that provides direct
support and administrative control of a branch.
Primary home health agency means the HHA which accepts the initial
referral of a patient, and which provides services directly to the
patient or via another health care provider under arrangements (as
applicable).
Proprietary agency means a private, for-profit agency.
Public agency means an agency operated by a state or local
government.
Quality indicator means a specific, valid, and reliable measure of
access, care outcomes, or satisfaction, or a measure of a process of
care.
Representative means the patient's legal representative, such as a
guardian, who makes health-care decisions on the patient's behalf, or a
patient-selected representative who participates in making decisions
related to the patient's care or well-being, including but not limited
to, a family member or an advocate for the patient. The patient
determines the role of the representative, to the extent possible.
Subdivision means a component of a multi-function health agency,
such as the home care department of a hospital or the nursing division
of a health department, which independently meets the conditions of
participation for HHAs. A subdivision that has branch offices is
considered a parent agency.
Summary report means the compilation of the pertinent factors of a
patient's clinical notes that is submitted to the patient's physician.
Supervised practical training means training in a practicum
laboratory or other setting in which the trainee demonstrates knowledge
while providing covered services to an individual under the direct
supervision of either a registered nurse or a licensed practical nurse
who is under the supervision of a registered nurse.
Verbal order means a physician order that is spoken to appropriate
personnel and later put in writing for the purposes of documenting as
well as establishing or revising the patient's plan of care.

Subpart B--Patient Care

Sec. 484.40 Condition of participation: Release of patient
identifiable OASIS information.

The HHA and agent acting on behalf of the HHA in accordance with a
written contract must ensure the confidentiality of all patient
identifiable information contained in the clinical record, including
OASIS data, and may not release patient identifiable OASIS information
to the public.

Sec. 484.45 Condition of participation: Reporting OASIS information.

HHAs must electronically report all OASIS data collected in
accordance with Sec. 484.55.
(a) Standard: Encoding and transmitting OASIS data. An HHA must
encode and electronically transmit each completed OASIS assessment to
the CMS system, regarding each beneficiary with respect to which
information is required to be transmitted (as determined by the
Secretary), within 30 days of completing the assessment of the
beneficiary.
(b) Standard: Accuracy of encoded OASIS data. The encoded OASIS
data must accurately reflect the patient's status at the time of
assessment.
(c) Standard: Transmittal of OASIS data. An HHA must--
(1) For all completed assessments, transmit OASIS data in a format
that meets the requirements of paragraph (d) of this section.
(2) Successfully transmit test data to the QIES ASAP System or CMS
OASIS contractor.
(3) Transmit data using electronic communications software that
complies with the Federal Information Processing Standard (FIPS 140-2,
issued May 25, 2001) from the HHA or the HHA contractor to the CMS
collection site.
(4) Transmit data that includes the CMS-assigned branch
identification number, as applicable.
(d) Standard: Data Format. The HHA must encode and transmit data
using the software available from CMS or software that conforms to CMS
standard electronic record layout, edit specifications, and data
dictionary, and that includes the required OASIS data set.

Sec. 484.50 Condition of participation: Patient rights.

The patient and representative (if any), have the right to be
informed of the patient's rights in a language and manner the
individual understands. The HHA must protect and promote the exercise
of these rights.
(a) Standard: Notice of rights. The HHA must--
(1) Provide the patient and the patient's legal representative (if
any), the following information during the initial evaluation visit, in
advance of furnishing care to the patient:
(i) Written notice of the patient's rights and responsibilities
under this rule, and the HHA's transfer and discharge policies as set
forth in paragraph (d) of this section. Written notice must be
understandable to persons who have limited English proficiency and
accessible to individuals with disabilities;
(ii) Contact information for the HHA administrator, including the
administrator's name, business address, and business phone number in
order to receive complaints.
(iii) An OASIS privacy notice to all patients for whom the OASIS
data is collected.
(2) Obtain the patient's or legal representative's signature
confirming

[[Page 4580]]

that he or she has received a copy of the notice of rights and
responsibilities.
(3) Provide verbal notice of the patient's rights and
responsibilities in the individual's primary or preferred language and
in a manner the individual understands, free of charge, with the use of
a competent interpreter if necessary, no later than the completion of
the second visit from a skilled professional as described in Sec.
484.75.
(4) Provide written notice of the patient's rights and
responsibilities under this rule and the HHA's transfer and discharge
policies as set forth in paragraph (d) of this section to a patient-
selected representative within 4 business days of the initial
evaluation visit.
(b) Standard: Exercise of rights. (1) If a patient has been
adjudged to lack legal capacity to make health care decisions as
established by state law by a court of proper jurisdiction, the rights
of the patient may be exercised by the person appointed by the state
court to act on the patient's behalf.
(2) If a state court has not adjudged a patient to lack legal
capacity to make health care decisions as defined by state law, the
patient's representative may exercise the patient's rights.
(3) If a patient has been adjudged to lack legal capacity to make
health care decisions under state law by a court of proper
jurisdiction, the patient may exercise his or her rights to the extent
allowed by court order.
(c) Standard: Rights of the patient. The patient has the right to--
(1) Have his or her property and person treated with respect;
(2) Be free from verbal, mental, sexual, and physical abuse,
including injuries of unknown source, neglect and misappropriation of
property;
(3) Make complaints to the HHA regarding treatment or care that is
(or fails to be) furnished, and the lack of respect for property and/or
person by anyone who is furnishing services on behalf of the HHA;
(4) Participate in, be informed about, and consent or refuse care
in advance of and during treatment, where appropriate, with respect
to--
(i) Completion of all assessments;
(ii) The care to be furnished, based on the comprehensive
assessment;
(iii) Establishing and revising the plan of care;
(iv) The disciplines that will furnish the care;
(v) The frequency of visits;
(vi) Expected outcomes of care, including patient-identified goals,
and anticipated risks and benefits;
(vii) Any factors that could impact treatment effectiveness; and
(viii) Any changes in the care to be furnished.
(5) Receive all services outlined in the plan of care.
(6) Have a confidential clinical record. Access to or release of
patient information and clinical records is permitted in accordance
with 45 CFR parts 160 and 164.
(7) Be advised of--
(i) The extent to which payment for HHA services may be expected
from Medicare, Medicaid, or any other federally-funded or federal aid
program known to the HHA,
(ii) The charges for services that may not be covered by Medicare,
Medicaid, or any other federally-funded or federal aid program known to
the HHA,
(iii) The charges the individual may have to pay before care is
initiated; and
(iv) Any changes in the information provided in accordance with
paragraph (c)(7) of this section when they occur. The HHA must advise
the patient and representative (if any), of these changes as soon as
possible, in advance of the next home health visit. The HHA must comply
with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR
411.408(f).
(8) Receive proper written notice, in advance of a specific service
being furnished, if the HHA believes that the service may be non-
covered care; or in advance of the HHA reducing or terminating on-going
care. The HHA must also comply with the requirements of 42 CFR 405.1200
through 405.1204.
(9) Be advised of the state toll free home health telephone hot
line, its contact information, its hours of operation, and that its
purpose is to receive complaints or questions about local HHAs.
(10) Be advised of the names, addresses, and telephone numbers of
the following Federally-funded and state-funded entities that serve the
area where the patient resides:
(i) Agency on Aging,
(ii) Center for Independent Living,
(iii) Protection and Advocacy Agency,
(iv) Aging and Disability Resource Center; and
(v) Quality Improvement Organization.
(11) Be free from any discrimination or reprisal for exercising his
or her rights or for voicing grievances to the HHA or an outside
entity.
(12) Be informed of the right to access auxiliary aids and language
services as described in paragraph (f) of this section, and how to
access these services.
(d) Standard: Transfer and discharge. The patient and
representative (if any), have a right to be informed of the HHA's
policies for transfer and discharge. The HHA may only transfer or
discharge the patient from the HHA if:
(1) The transfer or discharge is necessary for the patient's
welfare because the HHA and the physician who is responsible for the
home health plan of care agree that the HHA can no longer meet the
patient's needs, based on the patient's acuity. The HHA must arrange a
safe and appropriate transfer to other care entities when the needs of
the patient exceed the HHA's capabilities;
(2) The patient or payer will no longer pay for the services
provided by the HHA;
(3) The transfer or discharge is appropriate because the physician
who is responsible for the home health plan of care and the HHA agree
that the measurable outcomes and goals set forth in the plan of care in
accordance with Sec. 484.60(a)(2)(xiv) have been achieved, and the HHA
and the physician who is responsible for the home health plan of care
agree that the patient no longer needs the HHA's services;
(4) The patient refuses services, or elects to be transferred or
discharged;
(5) The HHA determines, under a policy set by the HHA for the
purpose of addressing discharge for cause that meets the requirements
of paragraphs (d)(5)(i) through (d)(5)(iii) of this section, that the
patient's (or other persons in the patient's home) behavior is
disruptive, abusive, or uncooperative to the extent that delivery of
care to the patient or the ability of the HHA to operate effectively is
seriously impaired. The HHA must do the following before it discharges
a patient for cause:
(i) Advise the patient, representative (if any), the physician(s)
issuing orders for the home health plan of care, and the patient's
primary care practitioner or other health care professional who will be
responsible for providing care and services to the patient after
discharge from the HHA (if any) that a discharge for cause is being
considered;
(ii) Make efforts to resolve the problem(s) presented by the
patient's behavior, the behavior of other persons in the patient's
home, or situation;
(iii) Provide the patient and representative (if any), with contact
information for other agencies or providers who may be able to provide
care; and
(iv) Document the problem(s) and efforts made to resolve the
problem(s), and enter this documentation into its clinical records;
(6) The patient dies; or
(7) The HHA ceases to operate.
(e) Standard: Investigation of complaints. (1) The HHA must--

[[Page 4581]]

(i) Investigate complaints made by a patient, the patient's
representative (if any), and the patient's caregivers and family,
including, but not limited to, the following topics:
(A) Treatment or care that is (or fails to be) furnished, is
furnished inconsistently, or is furnished inappropriately; and
(B) Mistreatment, neglect, or verbal, mental, sexual, and physical
abuse, including injuries of unknown source, and/or misappropriation of
patient property by anyone furnishing services on behalf of the HHA.
(ii) Document both the existence of the complaint and the
resolution of the complaint; and
(iii) Take action to prevent further potential violations,
including retaliation, while the complaint is being investigated.
(2) Any HHA staff (whether employed directly or under arrangements)
in the normal course of providing services to patients, who identifies,
notices, or recognizes incidences or circumstances of mistreatment,
neglect, verbal, mental, sexual, and/or physical abuse, including
injuries of unknown source, or misappropriation of patient property,
must report these findings immediately to the HHA and other appropriate
authorities in accordance with state law.
(f) Standard: Accessibility. Information must be provided to
patients in plain language and in a manner that is accessible and
timely to--
(1) Persons with disabilities, including accessible Web sites and
the provision of auxiliary aids and services at no cost to the
individual in accordance with the Americans with Disabilities Act and
Section 504 of the Rehabilitation Act.
(2) Persons with limited English proficiency through the provision
of language services at no cost to the individual, including oral
interpretation and written translations.

Sec. 484.55 Condition of participation: Comprehensive assessment of
patients.

Each patient must receive, and an HHA must provide, a patient-
specific, comprehensive assessment. For Medicare beneficiaries, the HHA
must verify the patient's eligibility for the Medicare home health
benefit including homebound status, both at the time of the initial
assessment visit and at the time of the comprehensive assessment.
(a) Standard: Initial assessment visit. (1) A registered nurse must
conduct an initial assessment visit to determine the immediate care and
support needs of the patient; and, for Medicare patients, to determine
eligibility for the Medicare home health benefit, including homebound
status. The initial assessment visit must be held either within 48
hours of referral, or within 48 hours of the patient's return home, or
on the physician-ordered start of care date.
(2) When rehabilitation therapy service (speech language pathology,
physical therapy, or occupational therapy) is the only service ordered
by the physician who is responsible for the home health plan of care,
and if the need for that service establishes program eligibility, the
initial assessment visit may be made by the appropriate rehabilitation
skilled professional.
(b) Standard: Completion of the comprehensive assessment. (1) The
comprehensive assessment must be completed in a timely manner,
consistent with the patient's immediate needs, but no later than 5
calendar days after the start of care.
(2) Except as provided in paragraph (b)(3) of this section, a
registered nurse must complete the comprehensive assessment and for
Medicare patients, determine eligibility for the Medicare home health
benefit, including homebound status.
(3) When physical therapy, speech-language pathology, or
occupational therapy is the only service ordered by the physician, a
physical therapist, speech-language pathologist or occupational
therapist may complete the comprehensive assessment, and for Medicare
patients, determine eligibility for the Medicare home health benefit,
including homebound status. The occupational therapist may complete the
comprehensive assessment if the need for occupational therapy
establishes program eligibility.
(c) Standard: Content of the comprehensive assessment. The
comprehensive assessment must accurately reflect the patient's status,
and must include, at a minimum, the following information:
(1) The patient's current health, psychosocial, functional, and
cognitive status;
(2) The patient's strengths, goals, and care preferences, including
information that may be used to demonstrate the patient's progress
toward achievement of the goals identified by the patient and the
measurable outcomes identified by the HHA;
(3) The patient's continuing need for home care;
(4) The patient's medical, nursing, rehabilitative, social, and
discharge planning needs;
(5) A review of all medications the patient is currently using in
order to identify any potential adverse effects and drug reactions,
including ineffective drug therapy, significant side effects,
significant drug interactions, duplicate drug therapy, and
noncompliance with drug therapy.
(6) The patient's primary caregiver(s), if any, and other available
supports, including their:
(i) Willingness and ability to provide care, and
(ii) Availability and schedules;
(7) The patient's representative (if any);
(8) Incorporation of the current version of the Outcome and
Assessment Information Set (OASIS) items, using the language and
groupings of the OASIS items, as specified by the Secretary. The OASIS
data items determined by the Secretary must include: clinical record
items, demographics and patient history, living arrangements,
supportive assistance, sensory status, integumentary status,
respiratory status, elimination status, neuro/emotional/behavioral
status, activities of daily living, medications, equipment management,
emergent care, and data items collected at inpatient facility admission
or discharge only.
(d) Standard: Update of the comprehensive assessment. The
comprehensive assessment must be updated and revised (including the
administration of the OASIS) as frequently as the patient's condition
warrants due to a major decline or improvement in the patient's health
status, but not less frequently than--
(1) The last 5 days of every 60 days beginning with the start-of-
care date, unless there is a--
(i) Beneficiary elected transfer;
(ii) Significant change in condition; or
(iii) 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 or more for any reason other than
diagnostic tests, or on physician-ordered resumption date;
(3) At discharge.

Sec. 484.60 Condition of participation: Care planning, coordination
of services, and quality of care.

Patients are accepted for treatment on the reasonable expectation
that an HHA can meet the patient's medical, nursing, rehabilitative,
and social needs in his or her place of residence. Each patient must
receive an individualized written plan of care, including any revisions
or additions. The individualized plan of care must specify the care and
services necessary to meet the patient-specific needs as identified in
the comprehensive assessment, including identification of the
responsible

[[Page 4582]]

discipline(s), and the measurable outcomes that the HHA anticipates
will occur as a result of implementing and coordinating the plan of
care. The individualized plan of care must also specify the patient and
caregiver education and training. Services must be furnished in
accordance with accepted standards of practice.
(a) Standard: Plan of care. (1) Each patient must receive the home
health services that are written in an individualized plan of care that
identifies patient-specific measurable outcomes and goals, and which is
established, periodically reviewed, and signed by a doctor of medicine,
osteopathy, or podiatry acting within the scope of his or her state
license, certification, or registration. If a physician refers a
patient under a plan of care that cannot be completed until after an
evaluation visit, the physician is consulted to approve additions or
modifications to the original plan.
(2) The individualized plan of care must include the following:
(i) All pertinent diagnoses;
(ii) The patient's mental, psychosocial, and cognitive status;
(iii) The types of services, supplies, and equipment required;
(iv) The frequency and duration of visits to be made;
(v) Prognosis;
(vi) Rehabilitation potential;
(vii) Functional limitations;
(viii) Activities permitted;
(ix) Nutritional requirements;
(x) All medications and treatments;
(xi) Safety measures to protect against injury;
(xii) A description of the patient's risk for emergency department
visits and hospital re-admission, and all necessary interventions to
address the underlying risk factors.
(xiii) Patient and caregiver education and training to facilitate
timely discharge;
(xiv) Patient-specific interventions and education; measurable
outcomes and goals identified by the HHA and the patient;
(xv) Information related to any advanced directives; and
(xvi) Any additional items the HHA or physician may choose to
include.
(3) All patient care orders, including verbal orders, must be
recorded in the plan of care.
(b) Standard: Conformance with physician orders. (1) Drugs,
services, and treatments are administered only as ordered by a
physician.
(2) Influenza and pneumococcal vaccines may be administered per
agency policy developed in consultation with a physician, and after an
assessment of the patient to determine for contraindications.
(3) Verbal orders must be accepted only by personnel authorized to
do so by applicable state laws and regulations and by the HHA's
internal policies.
(4) When services are provided on the basis of a physician's verbal
orders, a nurse acting in accordance with state licensure requirements,
or other qualified practitioner responsible for furnishing or
supervising the ordered services, in accordance with state law and the
HHA's policies, must document the orders in the patient's clinical
record, and sign, date, and time the orders. Verbal orders must be
authenticated and dated by the physician in accordance with applicable
state laws and regulations, as well as the HHA's internal policies.
(c) Standard: Review and revision of the plan of care. (1) The
individualized plan of care must be reviewed and revised by the
physician who is responsible for the home health plan of care and the
HHA as frequently as the patient's condition or needs require, but no
less frequently than once every 60 days, beginning with the start of
care date. The HHA must promptly alert the relevant physician(s) to any
changes in the patient's condition or needs that suggest that outcomes
are not being achieved and/or that the plan of care should be altered.
(2) A revised plan of care must reflect current information from
the patient's updated comprehensive assessment, and contain information
concerning the patient's progress toward the measurable outcomes and
goals identified by the HHA and patient in the plan of care.
(3) Revisions to the plan of care must be communicated as follows:
(i) Any revision to the plan of care due to a change in patient
health status must be communicated to the patient, representative (if
any), caregiver, and all physicians issuing orders for the HHA plan of
care.
(ii) Any revisions related to plans for the patient's discharge
must be communicated to the patient, representative, caregiver, all
physicians issuing orders for the HHA plan of care, and the patient's
primary care practitioner or other health care professional who will be
responsible for providing care and services to the patient after
discharge from the HHA (if any).
(d) Standard: Coordination of care. The HHA must:
(1) Assure communication with all physicians involved in the plan
of care.
(2) Integrate orders from all physicians involved in the plan of
care to assure the coordination of all services and interventions
provided to the patient.
(3) Integrate services, whether services are provided directly or
under arrangement, to assure the identification of patient needs and
factors that could affect patient safety and treatment effectiveness
and the coordination of care provided by all disciplines.
(4) Coordinate care delivery to meet the patient's needs, and
involve the patient, representative (if any), and caregiver(s), as
appropriate, in the coordination of care activities.
(5) Ensure that each patient, and his or her caregiver(s) where
applicable, receive ongoing education and training provided by the HHA,
as appropriate, regarding the care and services identified in the plan
of care. The HHA must provide training, as necessary, to ensure a
timely discharge.
(e) Standard: Written information to the patient. The HHA must
provide the patient and caregiver with a copy of written instructions
outlining:
(1) Visit schedule, including frequency of visits by HHA personnel
and personnel acting on behalf of the HHA.
(2) Patient medication schedule/instructions, including: medication
name, dosage and frequency and which medications will be administered
by HHA personnel and personnel acting on behalf of the HHA.
(3) Any treatments to be administered by HHA personnel and
personnel acting on behalf of the HHA, including therapy services.
(4) Any other pertinent instruction related to the patient's care
and treatments that the HHA will provide, specific to the patient's
care needs.
(5) Name and contact information of the HHA clinical manager.

Sec. 484.65 Condition of participation: Quality assessment and
performance improvement (QAPI).

The HHA must develop, implement, evaluate, and maintain an
effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's
governing body must ensure that the program reflects the complexity of
its organization and services; involves all HHA services (including
those services provided under contract or arrangement); focuses on
indicators related to improved outcomes, including the use of emergent
care services, hospital admissions and re-admissions; and takes actions
that address the HHA's performance across the spectrum of care,
including the prevention and reduction of medical errors. The HHA must
maintain documentary evidence of its QAPI

[[Page 4583]]

program and be able to demonstrate its operation to CMS.
(a) Standard: Program scope. (1) The program must at least be
capable of showing measurable improvement in indicators for which there
is evidence that improvement in those indicators will improve health
outcomes, patient safety, and quality of care.
(2) The HHA must measure, analyze, and track quality indicators,
including adverse patient events, and other aspects of performance that
enable the HHA to assess processes of care, HHA services, and
operations.
(b) Standard: Program data. (1) The program must utilize quality
indicator data, including measures derived from OASIS, where
applicable, and other relevant data, in the design of its program.
(2) The HHA must use the data collected to--
(i) Monitor the effectiveness and safety of services and quality of
care; and
(ii) Identify opportunities for improvement.
(3) The frequency and detail of the data collection must be
approved by the HHA's governing body.
(c) Standard: Program activities. (1) The HHA's performance
improvement activities must--
(i) Focus on high risk, high volume, or problem-prone areas;
(ii) Consider incidence, prevalence, and severity of problems in
those areas; and
(iii) Lead to an immediate correction of any identified problem
that directly or potentially threaten the health and safety of
patients.
(2) Performance improvement activities must track adverse patient
events, analyze their causes, and implement preventive actions.
(3) The HHA must take actions aimed at performance improvement,
and, after implementing those actions, the HHA must measure its success
and track performance to ensure that improvements are sustained.
(d) Standard: Performance improvement projects. Beginning January
13, 2018 HHAs must conduct performance improvement projects.
(1) The number and scope of distinct improvement projects conducted
annually must reflect the scope, complexity, and past performance of
the HHA's services and operations.
(2) The HHA must document the quality improvement projects
undertaken, the reasons for conducting these projects, and the
measurable progress achieved on these projects.
(e) Standard: Executive responsibilities. The HHA's governing body
is responsible for ensuring the following:
(1) That an ongoing program for quality improvement and patient
safety is defined, implemented, and maintained;
(2) That the HHA-wide quality assessment and performance
improvement efforts address priorities for improved quality of care and
patient safety, and that all improvement actions are evaluated for
effectiveness;
(3) That clear expectations for patient safety are established,
implemented, and maintained; and
(4) That any findings of fraud or waste are appropriately
addressed.

Sec. 484.70 Condition of participation: Infection prevention and
control.

The HHA must maintain and document an infection control program
which has as its goal the prevention and control of infections and
communicable diseases.
(a) Standard: Prevention. The HHA must follow accepted standards of
practice, including the use of standard precautions, to prevent the
transmission of infections and communicable diseases.
(b) Standard: Control. The HHA must maintain a coordinated agency-
wide program for the surveillance, identification, prevention, control,
and investigation of infectious and communicable diseases that is an
integral part of the HHA's quality assessment and performance
improvement (QAPI) program. The infection control program must include:
(1) A method for identifying infectious and communicable disease
problems; and
(2) A plan for the appropriate actions that are expected to result
in improvement and disease prevention.
(c) Standard: Education. The HHA must provide infection control
education to staff, patients, and caregiver(s).

Sec. 484.75 Condition of participation: Skilled professional
services.

Skilled professional services include skilled nursing services,
physical therapy, speech-language pathology services, and occupational
therapy, as specified in Sec. 409.44 of this chapter, and physician
and medical social work services as specified in Sec. 409.45 of this
chapter. Skilled professionals who provide services to HHA patients
directly or under arrangement must participate in the coordination of
care.
(a) Standard: Provision of services by skilled professionals.
Skilled professional services are authorized, delivered, and supervised
only by health care professionals who meet the appropriate
qualifications specified under Sec. 484.115 and who practice according
to the HHA's policies and procedures.
(b) Standard: Responsibilities of skilled professionals. Skilled
professionals must assume responsibility for, but not be restricted to,
the following:
(1) Ongoing interdisciplinary assessment of the patient;
(2) Development and evaluation of the plan of care in partnership
with the patient, representative (if any), and caregiver(s);
(3) Providing services that are ordered by the physician as
indicated in the plan of care;
(4) Patient, caregiver, and family counseling;
(5) Patient and caregiver education;
(6) Preparing clinical notes;
(7) Communication with all physicians involved in the plan of care
and other health care practitioners (as appropriate) related to the
current plan of care;
(8) Participation in the HHA's QAPI program; and
(9) Participation in HHA-sponsored in-service training.
(c) Supervision of skilled professional assistants. (1) Nursing
services are provided under the supervision of a registered nurse that
meets the requirements of Sec. 484.115(k).
(2) Rehabilitative therapy services are provided under the
supervision of an occupational therapist or physical therapist that
meets the requirements of Sec. 484.115(f) or (h), respectively.
(3) Medical social services are provided under the supervision of a
social worker that meets the requirements of Sec. 484.115(m).

Sec. 484.80 Condition of participation: Home health aide services.

All home health aide services must be provided by individuals who
meet the personnel requirements specified in paragraph (a) of this
section.
(a) Standard: Home health aide qualifications. (1) A qualified home
health aide is a person who has successfully completed:
(i) A training and competency evaluation program as specified in
paragraphs (b) and (c) respectively of this section; or
(ii) A competency evaluation program that meets the requirements of
paragraph (c) of this section; or
(iii) A nurse aide training and competency evaluation program
approved by the state as meeting the requirements of Sec. 483.151
through Sec. 483.154 of this chapter, and is

[[Page 4584]]

currently listed in good standing on the state nurse aide registry; or
(iv) The requirements of a state licensure program that meets the
provisions of paragraphs (b) and (c) of this section.
(2) A home health aide or nurse aide is not considered to have
completed a program, as specified in paragraph (a)(1) of this section,
if, since the individual's most recent completion of the program(s),
there has been a continuous period of 24 consecutive months during
which none of the services furnished by the individual as described in
Sec. 409.40 of this chapter were for compensation. If there has been a
24-month lapse in furnishing services for compensation, the individual
must complete another program, as specified in paragraph (a)(1) of this
section, before providing services.
(b) Standard: Content and duration of home health aide classroom
and supervised practical training. (1) Home health aide training must
include classroom and supervised practical training in a practicum
laboratory or other setting in which the trainee demonstrates knowledge
while providing services to an individual under the direct supervision
of a registered nurse, or a licensed practical nurse who is under the
supervision of a registered nurse. Classroom and supervised practical
training must total at least 75 hours.
(2) A minimum of 16 hours of classroom training must precede a
minimum of 16 hours of supervised practical training as part of the 75
hours.
(3) A home health aide training program must address each of the
following subject areas:
(i) Communication skills, including the ability to read, write, and
verbally report clinical information to patients, representatives, and
caregivers, as well as to other HHA staff.
(ii) Observation, reporting, and documentation of patient status
and the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection prevention and control procedures.
(v) Basic elements of body functioning and changes in body function
that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and the knowledge of instituting
emergency procedures and their application.
(viii) The physical, emotional, and developmental needs of and ways
to work with the populations served by the HHA, including the need for
respect for the patient, his or her privacy, and his or her property.
(ix) Appropriate and safe techniques in performing personal hygiene
and grooming tasks that include--
(A) Bed bath;
(B) Sponge, tub, and shower bath;
(C) Hair shampooing in sink, tub, and bed;
(D) Nail and skin care;
(E) Oral hygiene;
(F) Toileting and elimination;
(x) Safe transfer techniques and ambulation;
(xi) Normal range of motion and positioning;
(xii) Adequate nutrition and fluid intake;
(xiii) Recognizing and reporting changes in skin condition; and
(xiv) Any other task that the HHA may choose to have an aide
perform as permitted under state law.
(xv) The HHA is responsible for training home health aides, as
needed, for skills not covered in the basic checklist, as described in
paragraph (b)(3)(ix) of this section.
(4) The HHA must maintain documentation that demonstrates that the
requirements of this standard have been met.
(c) Standard: Competency evaluation. An individual may furnish home
health services on behalf of an HHA only after that individual has
successfully completed a competency evaluation program as described in
this section.
(1) The competency evaluation must address each of the subjects
listed in paragraph (b)(3) of this section. Subject areas specified
under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section
must be evaluated by observing an aide's performance of the task with a
patient. The remaining subject areas may be evaluated through written
examination, oral examination, or after observation of a home health
aide with a patient.
(2) A home health aide competency evaluation program may be offered
by any organization, except as specified in paragraph (f) of this
section.
(3) The competency evaluation must be performed by a registered
nurse in consultation with other skilled professionals, as appropriate.
(4) A home health aide is not considered competent in any task for
which he or she is evaluated as unsatisfactory. An aide must not
perform that task without direct supervision by a registered nurse
until after he or she has received training in the task for which he or
she was evaluated as ``unsatisfactory,'' and has successfully completed
a subsequent evaluation. A home health aide is not considered to have
successfully passed a competency evaluation if the aide has an
``unsatisfactory'' rating in more than one of the required areas.
(5) The HHA must maintain documentation which demonstrates that the
requirements of this standard have been met.
(d) Standard: In-service training. A home health aide must receive
at least 12 hours of in-service training during each 12-month period.
In-service training may occur while an aide is furnishing care to a
patient.
(1) In-service training may be offered by any organization and must
be supervised by a registered nurse.
(2) The HHA must maintain documentation that demonstrates the
requirements of this standard have been met.
(e) Standard: Qualifications for instructors conducting classroom
and supervised practical training. Classroom and supervised practical
training must be performed by a registered nurse who possesses a
minimum of 2 years nursing experience, at least 1 year of which must be
in home health care, or by other individuals under the general
supervision of the registered nurse.
(f) Standard: Eligible training and competency evaluation
organizations. A home health aide training program and competency
evaluation program may be offered by any organization except by an HHA
that, within the previous 2 years:
(1) Was out of compliance with the requirements of paragraphs (b),
(c), (d), or (e) of this section; or
(2) Permitted an individual who does not meet the definition of a
``qualified home health aide'' as specified in paragraph (a) of this
section to furnish home health aide services (with the exception of
licensed health professionals and volunteers); or
(3) Was subjected to an extended (or partially extended) survey as
a result of having been found to have furnished substandard care (or
for other reasons as determined by CMS or the state); or
(4) Was assessed a civil monetary penalty of $5,000 or more as an
intermediate sanction; or
(5) Was found to have compliance deficiencies that endangered the
health and safety of the HHA's patients, and had temporary management
appointed to oversee the management of the HHA; or
(6) Had all or part of its Medicare payments suspended; or
(7) Was found under any federal or state law to have:
(i) Had its participation in the Medicare program terminated; or

[[Page 4585]]

(ii) Been assessed a penalty of $5,000 or more for deficiencies in
federal or state standards for HHAs; or
(iii) Been subjected to a suspension of Medicare payments to which
it otherwise would have been entitled; or
(iv) Operated under temporary management that was appointed to
oversee the operation of the HHA and to ensure the health and safety of
the HHA's patients; or
(v) Been closed, or had its patients transferred by the state; or
(vi) Been excluded from participating in federal health care
programs or debarred from participating in any government program.
(g) Standard: Home health aide assignments and duties. (1) Home
health aides are assigned to a specific patient by a registered nurse
or other appropriate skilled professional, with written patient care
instructions for a home health aide prepared by that registered nurse
or other appropriate skilled professional (that is, physical therapist,
speech-language pathologist, or occupational therapist).
(2) A home health aide provides services that are:
(i) Ordered by the physician;
(ii) Included in the plan of care;
(iii) Permitted to be performed under state law; and
(iv) Consistent with the home health aide training.
(3) The duties of a home health aide include:
(i) The provision of hands-on personal care;
(ii) The performance of simple procedures as an extension of
therapy or nursing services;
(iii) Assistance in ambulation or exercises; and
(iv) Assistance in administering medications ordinarily self-
administered.
(4) Home health aides must be members of the interdisciplinary
team, must report changes in the patient's condition to a registered
nurse or other appropriate skilled professional, and must complete
appropriate records in compliance with the HHA's policies and
procedures.
(h) Standard: Supervision of home health aides. (1)(i) If home
health aide services are provided to a patient who is receiving skilled
nursing, physical or occupational therapy, or speech-language pathology
services, a registered nurse or other appropriate skilled professional
who is familiar with the patient, the patient's plan of care, and the
written patient care instructions described in Sec. 484.80(g), must
make an onsite visit to the patient's home no less frequently than
every 14 days. The home health aide does not have to be present during
this visit.
(ii) If an area of concern in aide services is noted by the
supervising registered nurse or other appropriate skilled professional,
then the supervising individual must make an on-site visit to the
location where the patient is receiving care in order to observe and
assess the aide while he or she is performing care.
(iii) A registered nurse or other appropriate skilled professional
must make an annual on-site visit to the location where a patient is
receiving care in order to observe and assess each aide while he or she
is performing care.
(2) If home health aide services are provided to a patient who is
not receiving skilled nursing care, physical or occupational therapy,
or speech-language pathology services, the registered nurse must make
an on-site visit to the location where the patient is receiving care no
less frequently than every 60 days in order to observe and assess each
aide while he or she is performing care.
(3) If a deficiency in aide services is verified by the registered
nurse or other appropriate skilled professional during an on-site
visit, then the agency must conduct, and the home health aide must
complete a competency evaluation in accordance with paragraph (c) of
this section.
(4) Home health aide supervision must ensure that aides furnish
care in a safe and effective manner, including, but not limited to, the
following elements:
(i) Following the patient's plan of care for completion of tasks
assigned to a home health aide by the registered nurse or other
appropriate skilled professional;
(ii) Maintaining an open communication process with the patient,
representative (if any), caregivers, and family;
(iii) Demonstrating competency with assigned tasks;
(iv) Complying with infection prevention and control policies and
procedures;
(v) Reporting changes in the patient's condition; and
(vi) Honoring patient rights.
(5) If the home health agency chooses to provide home health aide
services under arrangements, as defined in section 1861(w)(1) of the
Act, the HHA's responsibilities also include, but are not limited to:
(i) Ensuring the overall quality of care provided by an aide;
(ii) Supervising aide services as described in paragraphs (h)(1)
and (2) of this section; and
(iii) Ensuring that home health aides who provide services under
arrangement have met the training or competency evaluation
requirements, or both, of this part.
(i) Standard: Individuals furnishing Medicaid personal care aide-
only services under a Medicaid personal care benefit. An individual may
furnish personal care services, as defined in Sec. 440.167 of this
chapter, on behalf of an HHA. Before the individual may furnish
personal care services, the individual must meet all qualification
standards established by the state. The individual only needs to
demonstrate competency in the services the individual is required to
furnish.

Subpart C--Organizational Environment

Sec. 484.100 Condition of participation: Compliance with Federal,
State, and local laws and regulations related to the health and safety
of patients.

The HHA and its staff must operate and furnish services in
compliance with all applicable federal, state, and local laws and
regulations related to the health and safety of patients. If state or
local law provides licensing of HHAs, the HHA must be licensed.
(a) Standard: Disclosure of ownership and management information.
The HHA must comply with the requirements of part 420 subpart C, of
this chapter. The HHA also must disclose the following information to
the state survey agency at the time of the HHA's initial request for
certification, for each survey, and at the time of any change in
ownership or management:
(1) The names and addresses of all persons with an ownership or
controlling interest in the HHA as defined in Sec. 420.201, Sec.
420.202, and Sec. 420.206 of this chapter.
(2) The name and address of each person who is an officer, a
director, an agent, or a managing employee of the HHA as defined in
Sec. 420.201, Sec. 420.202, and Sec. 420.206 of this chapter.
(3) The name and business address of the corporation, association,
or other company that is responsible for the management of the HHA, and
the names and addresses of the chief executive officer and the
chairperson of the board of directors of that corporation, association,
or other company responsible for the management of the HHA.
(b) Standard: Licensing. The HHA, its branches, and all persons
furnishing services to patients must be licensed, certified, or
registered, as applicable, in accordance with the state licensing
authority as meeting those requirements.

[[Page 4586]]

(c) Standard: Laboratory services. (1) If the HHA engages in
laboratory testing outside of the context of assisting an individual in
self-administering a test with an appliance that has been cleared for
that purpose by the Food and Drug Administration, the testing must be
in compliance with all applicable requirements of part 493 of this
chapter. The HHA may not substitute its equipment for a patient's
equipment when assisting with self-administered tests.
(2) If the HHA refers specimens for laboratory testing, the
referral laboratory must be certified in the appropriate specialties
and subspecialties of services in accordance with the applicable
requirements of part 493 of this chapter.

Sec. 484.102 Condition of participation: Emergency preparedness.

The Home Health Agency (HHA) must comply with all applicable
Federal, State, and local emergency preparedness requirements. The HHA
must establish and maintain an emergency preparedness program that
meets the requirements of this section. The emergency preparedness
program must include, but not be limited to, the following elements:
(a) Emergency plan. The HHA must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least annually.
The plan must do all of the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified
by the risk assessment.
(3) Address patient population, including, but not limited to, the
type of services the HHA has the ability to provide in an emergency;
and continuity of operations, including delegations of authority and
succession plans.
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation, including documentation of the HHA's efforts to
contact such officials and, when applicable, of its participation in
collaborative and cooperative planning efforts.
(b) Policies and procedures. The HHA must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least annually. At a minimum, the policies and
procedures must address the following:
(1) The plans for the HHA's patients during a natural or man-made
disaster. Individual plans for each patient must be included as part of
the comprehensive patient assessment, which must be conducted according
to the provisions at Sec. 484.55.
(2) The procedures to inform State and local emergency preparedness
officials about HHA patients in need of evacuation from their
residences at any time due to an emergency situation based on the
patient's medical and psychiatric condition and home environment.
(3) The procedures to follow up with on-duty staff and patients to
determine services that are needed, in the event that there is an
interruption in services during or due to an emergency. The HHA must
inform State and local officials of any on-duty staff or patients that
they are unable to contact.
(4) A system of medical documentation that preserves patient
information, protects confidentiality of patient information, and
secures and maintains the availability of records.
(5) The use of volunteers in an emergency or other emergency
staffing strategies, including the process and role for integration of
State or Federally designated health care professionals to address
surge needs during an emergency.
(c) Communication plan. The HHA must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least
annually. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, or local emergency
preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the HHA's
staff, Federal, State, tribal, regional, and local emergency management
agencies.
(4) A method for sharing information and medical documentation for
patients under the HHA's care, as necessary, with other health care
providers to maintain the continuity of care.
(5) A means of providing information about the general condition
and location of patients under the facility's care as permitted under
45 CFR 164.510(b)(4).
(6) A means of providing information about the HHA's needs, and its
ability to provide assistance, to the authority having jurisdiction,
the Incident Command Center, or designee.
(d) Training and testing. The HHA must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least annually.
(1) Training program. The HHA must do all of the following:
(i) Initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing
services under arrangement, and volunteers, consistent with their
expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(ii) Demonstrate staff knowledge of emergency procedures.
(2) Testing. The HHA must conduct exercises to test the emergency
plan at least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based or
when a community-based exercise is not accessible, an individual,
facility-based. If the HHA experiences an actual natural or man-made
emergency that requires activation of the emergency plan, the HHA is
exempt from engaging in a community-based or individual, facility-based
full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based or
individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a
facilitator, using a narrated, clinically-relevant emergency scenario,
and a set of problem statements, directed messages, or prepared
questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
HHA's emergency plan, as needed.

[[Page 4587]]

(e) Integrated healthcare systems. If a HHA is part of a healthcare
system consisting of multiple separately certified healthcare
facilities that elects to have a unified and integrated emergency
preparedness program, the HHA may choose to participate in the
healthcare system's coordinated emergency preparedness program. If
elected, the unified and integrated emergency preparedness program must
do all of the following:
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively using the unified and integrated emergency preparedness
program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2), (3), and (4) of this section. The
unified and integrated emergency plan must also be based on and include
all of the following:
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for
each separately certified facility within the health system, utilizing
an all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.

Sec. 484.105 Condition of participation: Organization and
administration of services.

The HHA must organize, manage, and administer its resources to
attain and maintain the highest practicable functional capacity,
including providing optimal care to achieve the goals and outcomes
identified in the patient's plan of care, for each patient's medical,
nursing, and rehabilitative needs. The HHA must assure that
administrative and supervisory functions are not delegated to another
agency or organization, and all services not furnished directly are
monitored and controlled. The HHA must set forth, in writing, its
organizational structure, including lines of authority, and services
furnished.
(a) Standard: Governing body. A governing body (or designated
persons so functioning) must assume full legal authority and
responsibility for the agency's overall management and operation, the
provision of all home health services, fiscal operations, review of the
agency's budget and its operational plans, and its quality assessment
and performance improvement program.
(b) Standard: Administrator. (1) The administrator must:
(i) Be appointed by and report to the governing body;
(ii) Be responsible for all day-to-day operations of the HHA;
(iii) Ensure that a clinical manager as described in paragraph (c)
of this section is available during all operating hours;
(iv) Ensure that the HHA employs qualified personnel, including
assuring the development of personnel qualifications and policies.
(2) When the administrator is not available, a qualified, pre-
designated person, who is authorized in writing by the administrator
and the governing body, assumes the same responsibilities and
obligations as the administrator. The pre-designated person may be the
clinical manager as described in paragraph (c) of this section.
(3) The administrator or a pre-designated person is available
during all operating hours.
(c) Clinical manager. One or more qualified individuals must
provide oversight of all patient care services and personnel. Oversight
must include the following--
(1) Making patient and personnel assignments,
(2) Coordinating patient care,
(3) Coordinating referrals,
(4) Assuring that patient needs are continually assessed, and
(5) Assuring the development, implementation, and updates of the
individualized plan of care.
(d) Standard: Parent-branch relationship. (1) The parent HHA is
responsible for reporting all branch locations of the HHA to the state
survey agency at the time of the HHA's request for initial
certification, at each survey, and at the time the parent proposes to
add or delete a branch.
(2) The parent HHA provides direct support and administrative
control of its branches.
(e) Standard: Services under arrangement. (1) The HHA must ensure
that all services furnished under arrangement provided by other
entities or individuals meet the requirements of this part and the
requirements of section 1861(w) of the Act (42 U.S.C. 1395x (w)).
(2) An HHA must have a written agreement with another agency, with
an organization, or with an individual when that entity or individual
furnishes services under arrangement to the HHA's patients. The HHA
must maintain overall responsibility for the services provided under
arrangement, as well as the manner in which they are furnished. The
agency, organization, or individual providing services under
arrangement may not have been:
(i) Denied Medicare or Medicaid enrollment;
(ii) Been excluded or terminated from any federal health care
program or Medicaid;
(iii) Had its Medicare or Medicaid billing privileges revoked; or
(iv) Been debarred from participating in any government program.
(3) The primary HHA is responsible for patient care, and must
conduct and provide, either directly or under arrangements, all
services rendered to patients.
(f) Standard: Services furnished. (1) Skilled nursing services and
at least one other therapeutic service (physical therapy, speech-
language pathology, or occupational therapy; medical social services;
or home health aide services) are made available on a visiting basis,
in a place of residence used as a patient's home. An HHA must provide
at least one of the services described in this subsection directly, but
may provide the second service and additional services under
arrangement with another agency or organization.
(2) All HHA services must be provided in accordance with current
clinical practice guidelines and accepted professional standards of
practice.
(g) Standard: Outpatient physical therapy or speech-language
pathology services. An HHA that furnishes outpatient physical therapy
or speech-language pathology services must meet all of the applicable
conditions of this part and the additional health and safety
requirements set forth in Sec. 485.711, Sec. 485.713, Sec. 485.715,
Sec. 485.719, Sec. 485.723, and Sec. 485.727 of this chapter to
implement section 1861(p) of the Act.
(h) Standard: Institutional planning. The HHA, under the direction
of the governing body, prepares an overall plan and a budget that
includes an annual operating budget and capital expenditure plan.
(1) Annual operating budget. There is an annual operating budget
that includes all anticipated income and expenses related to items that
would,

[[Page 4588]]

under generally accepted accounting principles, be considered income
and expense items. However, it is not required that there be prepared,
in connection with any budget, an item by item identification of the
components of each type of anticipated income or expense.
(2) Capital expenditure plan. (i) There is a capital expenditure
plan for at least a 3-year period, including the operating budget year.
The plan includes and identifies in detail the anticipated sources of
financing for, and the objectives of, each anticipated expenditure of
more than $600,000 for items that would under generally accepted
accounting principles, be considered capital items. In determining if a
single capital expenditure exceeds $600,000, the cost of studies,
surveys, designs, plans, working drawings, specifications, and other
activities essential to the acquisition, improvement, modernization,
expansion, or replacement of land, plant, building, and equipment are
included. Expenditures directly or indirectly related to capital
expenditures, such as grading, paving, broker commissions, taxes
assessed during the construction period, and costs involved in
demolishing or razing structures on land are also included.
Transactions that are separated in time, but are components of an
overall plan or patient care objective, are viewed in their entirety
without regard to their timing. Other costs related to capital
expenditures include title fees, permit and license fees, broker
commissions, architect, legal, accounting, and appraisal fees;
interest, finance, or carrying charges on bonds, notes and other costs
incurred for borrowing funds.
(ii) If the anticipated source of financing is, in any part, the
anticipated payment from title V (Maternal and Child Health Services
Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the
Social Security Act, the plan specifies the following:
(A) Whether the proposed capital expenditure is required to
conform, or is likely to be required to conform, to current standards,
criteria, or plans developed in accordance with the Public Health
Service Act or the Mental Retardation Facilities and Community Mental
Health Centers Construction Act of 1963.
(B) Whether a capital expenditure proposal has been submitted to
the designated planning agency for approval in accordance with section
1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations.
(C) Whether the designated planning agency has approved or
disapproved the proposed capital expenditure if it was presented to
that agency.
(3) Preparation of plan and budget. The overall plan and budget is
prepared under the direction of the governing body of the HHA by a
committee consisting of representatives of the governing body, the
administrative staff, and the medical staff (if any) of the HHA.
(4) Annual review of plan and budget. The overall plan and budget
is reviewed and updated at least annually by the committee referred to
in paragraph (i)(3) of this section under the direction of the
governing body of the HHA.

Sec. 484.110 Condition of participation: Clinical records.

The HHA must maintain a clinical record containing past and current
information for every patient accepted by the HHA and receiving home
health services. Information contained in the clinical record must be
accurate, adhere to current clinical record documentation standards of
practice, and be available to the physician(s) issuing orders for the
home health plan of care, and appropriate HHA staff. This information
may be maintained electronically.
(a) Standard: Contents of clinical record. The record must include:
(1) The patient's current comprehensive assessment, including all
of the assessments from the most recent home health admission, clinical
notes, plans of care, and physician orders;
(2) All interventions, including medication administration,
treatments, and services, and responses to those interventions;
(3) Goals in the patient's plans of care and the patient's progress
toward achieving them;
(4) Contact information for the patient, the patient's
representative (if any), and the patient's primary caregiver(s);
(5) Contact information for the primary care practitioner or other
health care professional who will be responsible for providing care and
services to the patient after discharge from the HHA; and
(6)(i) A completed discharge summary that is sent to the primary
care practitioner or other health care professional who will be
responsible for providing care and services to the patient after
discharge from the HHA (if any) within 5 business days of the patient's
discharge; or
(ii) A completed transfer summary that is sent within 2 business
days of a planned transfer, if the patient's care will be immediately
continued in a health care facility; or
(iii) A completed transfer summary that is sent within 2 business
days of becoming aware of an unplanned transfer, if the patient is
still receiving care in a health care facility at the time when the HHA
becomes aware of the transfer.
(b) Standard: Authentication. All entries must be legible, clear,
complete, and appropriately authenticated, dated, and timed.
Authentication must include a signature and a title (occupation), or a
secured computer entry by a unique identifier, of a primary author who
has reviewed and approved the entry.
(c) Standard: Retention of records. (1) Clinical records must be
retained for 5 years after the discharge of the patient, unless state
law stipulates a longer period of time.
(2) The HHA's policies must provide for retention of clinical
records even if it discontinues operation. When an HHA discontinues
operation, it must inform the state agency where clinical records will
be maintained.
(d) Standard: Protection of records. The clinical record, its
contents, and the information contained therein must be safeguarded
against loss or unauthorized use. The HHA must be in compliance with
the rules regarding protected health information set out at 45 CFR
parts 160 and 164.
(e) Standard: Retrieval of clinical records. A patient's clinical
record (whether hard copy or electronic form) must be made available to
a patient, free of charge, upon request at the next home visit, or
within 4 business days (whichever comes first).

Sec. 484.115 Condition of participation: Personnel qualifications.

HHA staff are required to meet the following standards:
(a) Standard: Administrator, home health agency. (1) For
individuals that began employment with the HHA prior to July 13, 2017,
a person who:
(i) Is a licensed physician;
(ii) Is a registered nurse; or
(iii) Has training and experience in health service administration
and at least 1 year of supervisory administrative experience in home
health care or a related health care program.
(2) For individuals that begin employment with an HHA on or after
July 13, 2017, a person who:
(i) Is a licensed physician, a registered nurse, or holds an
undergraduate degree; and
(ii) Has experience in health service administration, with at least
1 year of supervisory or administrative

[[Page 4589]]

experience in home health care or a related health care program.
(b) Standard: Audiologist. A person who:
(1) Meets the education and experience requirements for a
Certificate of Clinical Competence in audiology granted by the American
Speech-Language-Hearing Association; or
(2) Meets the educational requirements for certification and is in
the process of accumulating the supervised experience required for
certification.
(c) Standard: Clinical manager. A person who is a licensed
physician, physical therapist, speech-language pathologist,
occupational therapist, audiologist, social worker, or a registered
nurse.
(d) Standard: Home health aide. A person who meets the
qualifications for home health aides specified in section 1891(a)(3) of
the Act and implemented at Sec. 484.80.
(e) Standard: Licensed practical (vocational) nurse. A person who
has completed a practical (vocational) nursing program, is licensed in
the state where practicing, and who furnishes services under the
supervision of a qualified registered nurse.
(f) Standard: Occupational therapist. A person who--
(1)(i) Is licensed or otherwise regulated, if applicable, as an
occupational therapist by the state in which practicing, unless
licensure does not apply;
(ii) Graduated after successful completion of an occupational
therapist education program accredited by the Accreditation Council for
Occupational Therapy Education (ACOTE) of the American Occupational
Therapy Association, Inc. (AOTA), or successor organizations of ACOTE;
and
(iii) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed
and administered by the National Board for Certification in
Occupational Therapy, Inc. (NBCOT).
(2) On or before December 31, 2009--
(i) Is licensed or otherwise regulated, if applicable, as an
occupational therapist by the state in which practicing; or
(ii) When licensure or other regulation does not apply--
(A) Graduated after successful completion of an occupational
therapist education program accredited by the accreditation Council for
Occupational Therapy Education (ACOTE) of the American Occupational
Therapy Association, Inc. (AOTA) or successor organizations of ACOTE;
and
(B) Is eligible to take, or has successfully completed the entry-
level certification examination for occupational therapists developed
and administered by the National Board for Certification in
Occupational Therapy, Inc., (NBCOT).
(3) On or before January 1, 2008--
(i) Graduated after successful completion of an occupational
therapy program accredited jointly by the Committee on Allied Health
Education and Accreditation of the American Medical Association and the
American Occupational Therapy Association; or
(ii) Is eligible for the National Registration Examination of the
American Occupational Therapy Association or the National Board for
Certification in Occupational Therapy.
(4) On or before December 31, 1977--
(i) Had 2 years of appropriate experience as an occupational
therapist; and
(ii) Had achieved a satisfactory grade on an occupational therapist
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service.
(5) If educated outside the United States, must meet both of the
following:
(i) Graduated after successful completion of an occupational
therapist education program accredited as substantially equivalent to
occupational therapist entry level education in the United States by
one of the following:
(A) The Accreditation Council for Occupational Therapy Education
(ACOTE).
(B) Successor organizations of ACOTE.
(C) The World Federation of Occupational Therapists.
(D) A credentialing body approved by the American Occupational
Therapy Association.
(E) Successfully completed the entry level certification
examination for occupational therapists developed and administered by
the National Board for Certification in Occupational Therapy, Inc.
(NBCOT).
(ii) On or before December 31, 2009, is licensed or otherwise
regulated, if applicable, as an occupational therapist by the state in
which practicing.
(g) Standard: Occupational therapy assistant. A person who--
(1) Meets all of the following:
(i) Is licensed or otherwise regulated, if applicable, as an
occupational therapy assistant by the state in which practicing, unless
licensure does apply.
(ii) Graduated after successful completion of an occupational
therapy assistant education program accredited by the Accreditation
Council for Occupational Therapy Education, (ACOTE) of the American
Occupational Therapy Association, Inc. (AOTA) or its successor
organizations.
(iii) Is eligible to take or successfully completed the entry-level
certification examination for occupational therapy assistants developed
and administered by the National Board for Certification in
Occupational Therapy, Inc. (NBCOT).
(2) On or before December 31, 2009--
(i) Is licensed or otherwise regulated as an occupational therapy
assistant, if applicable, by the state in which practicing; or any
qualifications defined by the state in which practicing, unless
licensure does not apply; or
(ii) Must meet both of the following:
(A) Completed certification requirements to practice as an
occupational therapy assistant established by a credentialing
organization approved by the American Occupational Therapy Association.
(B) After January 1, 2010, meets the requirements in paragraph
(f)(1) of this section.
(3) After December 31, 1977 and on or before December 31, 2007--
(i) Completed certification requirements to practice as an
occupational therapy assistant established by a credentialing
organization approved by the American Occupational Therapy Association;
or
(ii) Completed the requirements to practice as an occupational
therapy assistant applicable in the state in which practicing.
(4) On or before December 31, 1977--
(i) Had 2 years of appropriate experience as an occupational
therapy assistant; and
(ii) Had achieved a satisfactory grade on an occupational therapy
assistant proficiency examination conducted, approved, or sponsored by
the U.S. Public Health Service.
(5) If educated outside the United States, on or after January 1,
2008--
(i) Graduated after successful completion of an occupational
therapy assistant education program that is accredited as substantially
equivalent to occupational therapist assistant entry level education in
the United States by--
(A) The Accreditation Council for Occupational Therapy Education
(ACOTE).
(B) Its successor organizations.
(C) The World Federation of Occupational Therapists.
(D) By a credentialing body approved by the American Occupational
Therapy Association; and
(E) Successfully completed the entry level certification
examination for occupational therapy assistants developed and
administered by the

[[Page 4590]]

National Board for Certification in Occupational Therapy, Inc. (NBCOT).
(ii) [Reserved]
(h) Standard: Physical therapist. A person who is licensed, if
applicable, by the state in which practicing, unless licensure does not
apply and meets one of the following requirements:
(1)(i) Graduated after successful completion of a physical
therapist education program approved by one of the following:
(A) The Commission on Accreditation in Physical Therapy Education
(CAPTE).
(B) Successor organizations of CAPTE.
(C) An education program outside the United States determined to be
substantially equivalent to physical therapist entry level education in
the United States by a credentials evaluation organization approved by
the American Physical Therapy Association or an organization identified
in 8 CFR 212.15(e) as it relates to physical therapists.
(ii) Passed an examination for physical therapists approved by the
state in which physical therapy services are provided.
(2) On or before December 31, 2009--
(i) Graduated after successful completion of a physical therapy
curriculum approved by the Commission on Accreditation in Physical
Therapy Education (CAPTE); or
(ii) Meets both of the following:
(A) Graduated after successful completion of an education program
determined to be substantially equivalent to physical therapist entry
level education in the United States by a credentials evaluation
organization approved by the American Physical Therapy Association or
identified in 8 CFR 212.15(e) as it relates to physical therapists.
(B) Passed an examination for physical therapists approved by the
state in which physical therapy services are provided.
(3) Before January 1, 2008 graduated from a physical therapy
curriculum approved by one of the following:
(i) The American Physical Therapy Association.
(ii) The Committee on Allied Health Education and Accreditation of
the American Medical Association.
(iii) The Council on Medical Education of the American Medical
Association and the American Physical Therapy Association.
(4) On or before December 31, 1977 was licensed or qualified as a
physical therapist and meets both of the following:
(i) Has 2 years of appropriate experience as a physical therapist.
(ii) Has achieved a satisfactory grade on a proficiency examination
conducted, approved, or sponsored by the U.S. Public Health Service.
(5) Before January 1, 1966--
(i) Was admitted to membership by the American Physical Therapy
Association;
(ii) Was admitted to registration by the American Registry of
Physical Therapists; or
(iii) Graduated from a physical therapy curriculum in a 4-year
college or university approved by a state department of education.
(6) Before January 1, 1966 was licensed or registered, and before
January 1, 1970, had 15 years of fulltime experience in the treatment
of illness or injury through the practice of physical therapy in which
services were rendered under the order and direction of attending and
referring doctors of medicine or osteopathy.
(7) If trained outside the United States before January 1, 2008,
meets the following requirements:
(i) Was graduated since 1928 from a physical therapy curriculum
approved in the country in which the curriculum was located and in
which there is a member organization of the World Confederation for
Physical Therapy.
(ii) Meets the requirements for membership in a member organization
of the World Confederation for Physical Therapy.
(i) Standard: Physical therapist assistant. A person who is
licensed, registered or certified as a physical therapist assistant, if
applicable, by the state in which practicing, unless licensure does not
apply and meets one of the following requirements:
(1)(i) Graduated from a physical therapist assistant curriculum
approved by the Commission on Accreditation in Physical Therapy
Education of the American Physical Therapy Association; or if educated
outside the United States or trained in the United States military,
graduated from an education program determined to be substantially
equivalent to physical therapist assistant entry level education in the
United States by a credentials evaluation organization approved by the
American Physical Therapy Association or identified at 8 CFR 212.15(e);
and
(ii) Passed a national examination for physical therapist
assistants.
(2) On or before December 31, 2009, meets one of the following:
(i) Is licensed, or otherwise regulated in the state in which
practicing.
(ii) In states where licensure or other regulations do not apply,
graduated before December 31, 2009, from a 2-year college-level program
approved by the American Physical Therapy Association and after January
1, 2010, meets the requirements of paragraph (h)(1) of this section.
(3) Before January 1, 2008, where licensure or other regulation
does not apply, graduated from a 2-year college level program approved
by the American Physical Therapy Association.
(4) On or before December 31, 1977, was licensed or qualified as a
physical therapist assistant and has achieved a satisfactory grade on a
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service.
(j) Standard: Physician. A person who meets the qualifications and
conditions specified in section 1861(r) of the Act and implemented at
Sec. 410.20(b) of this chapter.
(k) Standard: Registered nurse. A graduate of an approved school of
professional nursing who is licensed in the state where practicing.
(l) Standard: Social Work Assistant. A person who provides services
under the supervision of a qualified social worker and:
(1) Has a baccalaureate degree in social work, psychology,
sociology, or other field related to social work, and has had at least
1 year of social work experience in a health care setting; or
(2) Has 2 years of appropriate experience as a social work
assistant, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that the determinations of proficiency do not apply
with respect to persons initially licensed by a state or seeking
initial qualification as a social work assistant after December 31,
1977.
(m) Standard: Social worker. A person who has a master's or
doctoral degree from a school of social work accredited by the Council
on Social Work Education, and has 1 year of social work experience in a
health care setting.
(n) Standard: 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:
(1) Is licensed as a speech-language pathologist by the state in
which the individual furnishes such services; or
(2) In the case of an individual who furnishes services in a state
which does not license speech-language pathologists:
(i) Has successfully completed 350 clock hours of supervised
clinical practicum (or is in the process of accumulating supervised
clinical experience);

[[Page 4591]]

(ii) 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
(iii) Successfully completed a national examination in speech-
language pathology approved by the Secretary.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
11. The authority citation for part 485 continues to read as follows:

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

0
12. In the table below, for each section and paragraph indicated in the
first two columns, remove the reference indicated in the third column
and add the reference indicated in the fourth column:

Sec. 485.58........................ Introductory text...... and 484.4.............. and 484.115.
Sec. 485.70........................ (c) and (e)............ Sec. 484.4........... Sec. 484.115.
----------------------------------------------------------------------------------------------------------------

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

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

Authority: Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the
Social Security Act, unless otherwise noted (42 U.S.C 1302, 1320a-
7j, 1395aa, 1395bb, 1395hh) and 1395ll.

Sec. 488.805 [Amended]

0
14. In Sec. 488.805, in the definition of ``temporary management'',
remove ``Sec. Sec. 484.4 and 484.14(c)'' and add in its place
``Sec. Sec. 484.105(b) and 484.115''.

Dated: December 8, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.

Dated: December 9, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.

[FR Doc. 2017-00283 Filed 1-9-17; 4:15 pm]
BILLING CODE 4120-01-P