[Federal Register Volume 79, Number 196 (Thursday, October 9, 2014)]
[Proposed Rules]
[Pages 61164-61213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23895]



[[Page 61163]]

Vol. 79

Thursday,

No. 196

October 9, 2014

Part III





Department of Health and Human Services





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Centers for Medicare and 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; Proposed Rule

  Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / 
Proposed Rules  

[[Page 61164]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

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

[CMS-3819-P]
RIN 0938-AG81


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

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would revise the current conditions of 
participation (CoPs) that home health agencies (HHAs) must meet in 
order to participate in the Medicare and Medicaid programs. The 
proposed requirements would focus on the care delivered to patients by 
home health agencies, reflect an interdisciplinary view of patient 
care, allow home health agencies 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: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on December 8, 2014.

ADDRESSES: In commenting, please refer to file code CMS-3819-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the instructions under 
the more search options tab.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3819-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3819-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original) before the close of the 
comment period to either of the following addresses: a. Room 445-G, 
Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, 
DC 20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal Government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    Submission of comments on paperwork requirements. You may submit 
comments on this document's paperwork requirements by following the 
instructions at the end of the ``Collection of Information 
Requirements'' section in this document.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:
    Danielle Shearer (410) 786-6617.
    Jacqueline Leach (410) 786-4282.
    Maria Hammel (410) 786-1775.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Introduction

    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 proposing to revise 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. We have 
developed a proposed set of fundamental requirements for Home Health 
Agency (HHA) services that would encompass patient rights, 
comprehensive patient assessment, and patient care planning and 
coordination by an interdisciplinary team. Overarching these 
requirements would be a quality assessment and performance improvement 
program that would build on the philosophy that a provider's own 
quality management system is key to improved patient care performance. 
The objective would be to achieve a balanced regulatory approach by 
ensuring that a HHA furnished health care that met essential health and 
quality standards, while ensuring that it monitored and improved its 
own performance.

[[Page 61165]]

Health Disparities

    In 1985, the Secretary of the Department of Health and Human 
Services issued a landmark report which revealed large and persistent 
gaps in health status among Americans of different racial and ethnic 
groups and served as an impetus for addressing health inequalities for 
racial and ethnic minorities in the U.S. This report led to the 
establishment of the Office of Minority Health (OMH) within the 
Department of Health and Human Services (HHS), with a mission to 
address these disparities throughout the Nation. National concerns for 
these differences in health outcomes between populations, termed health 
disparities, and the associated excess mortality and morbidity rates 
have been expressed as a high priority in national health status 
reviews, including Healthy People 2000, 2010, and 2020. In 2011, HHS 
also issued the HHS Action Plan to Reduce Racial and Ethnic Health 
Disparities (found at http://www.minorityhealth.hhs.gov/npa/templates/content.aspx?lvl=1&lvlid=33&ID=285).
    Since this time, research has extensively documented the 
pervasiveness of disparities in health care and has led to the 
acknowledgement of disparities as a national problem, expansion of 
populations identified as vulnerable, development of programs and 
strategies to reduce disparities for vulnerable populations, and the 
emergence of new leadership to address these disparities. Vulnerable 
populations include groups of people who have systematically 
experienced greater obstacles to health based on their racial or ethnic 
groups; religion; socioeconomic status; gender; age; mental health; 
cognitive, sensory, or physical disability; sexual orientation or 
gender identity; geographic location; or other characteristics 
historically linked to discrimination or exclusion. We are aware that 
other populations at risk may include pregnant women, infants, persons 
with limited English proficiency (LEP), and persons with disabilities 
(for example, visual, hearing, cognitive or perceptual impairments) or 
special health care needs.
    Although there has been much attention at the national level given 
to ideas for reducing health disparities in vulnerable populations, we 
remain vigilant in our efforts to improve health care quality for all 
persons by improving health care access and by eliminating real and 
perceived barriers to care that may contribute to less than optimal 
health outcomes for vulnerable populations. Despite the long-term 
implementation of some strategies like providing oral interpretation 
services to persons with LEP in hospitals, effective communication and 
its impact on health care outcomes continues to be in the forefront of 
the national discussion.
    We believe some aspects of this proposed rule, such as requiring 
patient rights to be explained to a patient in the language and manner 
that he or she understands, would address the needs of vulnerable 
populations and contribute to eliminating health disparities. We are 
specifically requesting comments in regard to how our proposed 
requirements could be used to address disparities.

II. Background

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, an HHA that 
participates in the Medicare or Medicaid programs, and are provided on 
a visiting basis in the beneficiary's home. Services 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 education 
program.
     Services at hospitals, skilled nursing facilities, or 
rehabilitation centers when they 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 
Social Security Act (the Act) describes an HHA for purposes of 
participation in the Medicare program in broadly descriptive terms. All 
the requirements are stated generally as applicable to the HHA's 
overall activity, and not specifically to the Medicare patient. This 
provision, which was reaffirmed by Congress in the 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 conditions of participation.

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,

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rehabilitation, social, and discharge planning needs.
    We also issued an interim final rule with comment period on January 
25, 1999 (64 FR 3748) that required HHAs to use the Outcome and 
Assessment Information Set (OASIS) data collection instrument that 
standardizes parts of the assessment. This rule also required HHAs to 
transmit the data to CMS. Section 1891(c)(2)(C) and section 1891(d)(1) 
of the Social Security Act (the Act) 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) in order to implement this statutory requirement.
    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 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 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.

C. Transforming the HHA Conditions of Participation

    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.
    Based on these principles, we are proposing new HHA CoPs that would 
revise or eliminate many current requirements and would focus provider 
efforts on the services delivered to the patient, the quality of care 
furnished by the HHA, and quality assessment and performance 
improvement efforts. We propose to establish the following four CoPs 
(in addition to retaining the current requirements at Sec.  484.55, 
Comprehensive assessment of patients):
    [ssquf] ``Patient rights'' would emphasize a HHA's responsibility 
to respect and promote the rights of each home health patient.
    [ssquf] ``Care planning, coordination of services, and quality of 
care'' would incorporate the interdisciplinary team approach to provide 
home health services focusing on the care planning, coordination of 
services, and quality of care processes.
    [ssquf] ``Quality assessment and performance improvement'' (QAPI) 
would charge each HHA with responsibility for carrying out an ongoing 
quality assessment, incorporating data-driven goals, and an evidence-
based performance improvement program of its own design to affect 
continuing improvement in the quality of care furnished to its 
patients.
    [ssquf] ``Infection prevention and control'' would require HHAs to 
follow accepted standards of practice to prevent and control the 
transmission of infectious diseases and to educate staff, patients, and 
family members or other caregivers on these accepted standards. The HHA 
would be required to incorporate an infection control component into 
its QAPI program.
    In the revised CoPs, we propose to retain and/or include process-
oriented requirements that are predictive of ensuring desired outcomes. 
We propose to eliminate many of the process details from the current 
requirements where they do not achieve this goal. For example, we 
propose to remove the process requirement under current Sec.  484.12(c) 
that a HHA and its staff comply with accepted professional standards 
and principles. Instead, we propose to modify this requirement by 
referencing current clinical practice guidelines and professional 
standards specific to home care (for example, the ANA Scope and 
Standards of Practice for Home Health Nurses) as factors to be 
considered in the HHA's overall QAPI program. We are not proposing to 
incorporate by reference any specific clinical practice guidelines or 
professional standards of practice. The HHA would be responsible for 
identifying its own performance problems through its QAPI program, 
addressing them, and continuously striving to improve the quality of 
clinical care, patient outcomes and satisfaction, as well as efficiency 
and economy. We also propose to remove the requirements that the HHA 
send a summary of care to the attending physician at least once every 
60 days, that the HHA have a group of professional personnel to advise 
its operation, and that the HHA conduct a quarterly evaluation of its 
program via chart reviews.
    We believe that the proposed CoPs, which are based on the 
principles of continuous and ongoing quality assessment and performance 
improvement, reflect a fundamental change in our regulatory approach--a 
change that to a large extent establishes a shared commitment between 
CMS and HHA providers to achieve improvements in the quality of care 
furnished to HHA patients. This approach has already been implemented 
through the Conditions of Participation/Conditions for Coverage (CoPs/
CfCs) for end-stage renal disease suppliers, hospitals, hospices, 
transplant centers, and organ procurement organizations.

[[Page 61167]]

The proposed HHA CoPs would prompt HHAs to invest internally in their 
responsibility to continuously improve performance, rather than relying 
solely on an external approach in which prescriptive federal 
requirements are enforced through the survey process. We anticipate 
that this patient-centered, outcome-oriented approach will result in an 
enhanced working relationship between state survey agencies and HHAs. 
These requirements would provide a basis for improved performance that 
will help to ensure that quality home health care is provided to all 
patients.
    These proposed regulations contain two critical improvements that 
would support and extend our focus on patient-centered, outcome-
oriented surveys. First, the proposed regulations are designed to 
enable surveyors to look at outcomes of care, because the regulations 
would specify that each individual receive 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 would not only stimulate the HHA to 
continuously monitor its performance and find opportunities for 
improvement, it would also afford the surveyor the ability to assess 
how effectively the provider was pursuing a continuous quality 
improvement agenda. All of the changes would be directed toward 
improving patient-centered outcomes of care, and engaging the patient, 
family and physician in the care planning and care delivery processes. 
We believe that the overall approach of the proposed CoPs would provide 
HHAs with greatly enhanced flexibility. At the same time, the proposed 
requirement for a program of continuous quality assessment and 
performance improvement would increase performance expectations for 
HHAs, in terms of achieving needed and desired outcomes for patients 
and increasing patient satisfaction with services provided.

III. Provisions of the Proposed Rule

A. Overview

    Under our proposal, the HHA CoPs would continue to be set forth in 
regulations under 42 CFR part 484. However, since many of the current 
requirements in part 484 would be revised, consolidated with other 
requirements, or eliminated, this proposed rule would make extensive 
changes in the current organizational scheme. The most significant 
change would be grouping together all CoPs directly related to patient 
care and place them near the beginning of part 484. Regulations 
concerning the organization and administration of a HHA would follow in 
a separate subpart titled ``Organizational Environment.'' This format 
would be better in keeping with the patient-centered orientation of 
these regulations, and would reinforce our view that patient 
assessment, care planning, and quality assessment and performance 
improvement efforts are central to the delivery of high quality care.

B. Proposed Subpart A, General Provisions

    We propose to reorganize this section to clarify the basis and 
scope of this part. Specifically, Sec.  484.1 would set out the 
statutory authority for these regulations. Part 484 is based on 
sections 1861(o) and 1891 of the Act, which establish the conditions 
that a 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. Currently, Sec.  484.1(a)(3) refers to section 1895 of the 
Act, which serves as the basis for the establishment of a prospective 
payment system for home health services covered under Medicare. This 
section of the Act is already cited at Sec.  484.200 as the basis for 
subpart E of this part, Prospective Payment System for Home Health 
Agencies, therefore, we propose to delete Sec.  484.1(a)(3).
    At Sec.  484.2, we propose to clarify some of the definitions for 
terms used in the HHA CoPs. The definition for ``branch office'' would 
be modified 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. The supervision and administrative control 
would have to assure that the quality and scope of items and services 
provided was of the highest practicable level for all patients, so as 
to meet their medical, nursing, and rehabilitative needs. Though the 
definition would no longer require the branch office to be 
``sufficiently close,'' the parent agency would have to be 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 propose minor changes in the language of the current 
definitions for ``clinical note,'' ``parent home health agency,'' 
``proprietary agency,'' and ``subdivision.'' These changes would 
achieve greater clarity within these definitions and achieve 
consistency with the other definitions contained in this section.
    We also propose to eliminate current definitions of the terms 
``bylaws'' and ``supervision.'' We believe the meanings of these terms 
are self-evident, and would provide sub-regulatory guidance on them in 
the future, should there be a need for such guidance. We are proposing 
to eliminate the definition for ``home health agency'' because its 
definition is set out by statute at section 1861(o) of the Act. We 
propose to delete the term ``progress notes'' because notations in the 
clinical record and more typically referred to as ``clinical notes,'' a 
term that is well defined and understood in the HHA industry.
    We propose to delete the term ``subunit'' because the distinction 
between the requirements that the parent HHA and a subunit must meet 
are minor. Currently, a subunit must be able, independently, to meet 
the CoPs. The distinction between a ``subunit'' of a HHA and an 
independent HHA is that a ``subunit'' may share the same governing 
body, administrator, and group of professional personnel with its 
parent HHA. In practice, the requirement that a ``subunit'' must 
independently meet the CoPs renders this distinction moot, and we 
believe that an entity operating for all intents and purposes as a 
distinct HHA should be treated as such. Therefore, upon finalization of 
this rule, existing subunits, which already operate under their own 
provider number, would be considered distinct HHAs and would be 
required to independently meet all CoPs without sharing a governing 
body or administrator. We propose to delete the requirements for the 
group of professional personnel; therefore it would no long matter if 
this group was shared among HHAs. Based on state-specific laws and 
regulations, this federal regulatory change would permit a subunit to 
apply to become a branch of its existing parent HHA if the parent 
provided ``. . . direct support and administrative control'' of the 
branch. The state survey agency and CMS Regional Office are responsible 
for approving a HHA's application for a branch office, in accordance 
with current CMS guidance as set out in various survey and 
certification letters

[[Page 61168]]

and section 2182.4B of the State Operations Manual. No new subunits 
would be approved upon implementation of this regulation, only ``branch 
offices.''
    Finally, we propose to add definitions for the terms ``in 
advance,'' ``quality indicator,'' ``representative,'' ``supervised 
practical training,'' and ``verbal order.'' We would add a definition 
for the term ``quality indicator'' because the use of quality 
indicators is central to a HHA's successful implementation of a quality 
assessment and performance improvement program. HHAs already have 
numerous quality indicators available to them through the OASIS. The 
OASIS data set provides empirical data to measure the quality of care a 
Medicare patient receives from an HHA, including care delivery, patient 
outcomes, and potentially avoidable events. The data are able to 
demonstrate trends across time. The OASIS data and the measures 
calculated from that data are indicators of quality that can be used 
for internal quality improvement efforts, in the survey process, and in 
the consumer decision-making process. However, the HHA quality 
indicators would not be limited to data gathered by the OASIS 
instrument or even measures calculated by CMS. HHAs may also identify 
quality indicators from outside sources such as research projects, 
collaborative QIO endeavors, and accrediting bodies, to name a few.
    We propose to define the term ``representative'' in a patient-
centered manner that enables patients to choose their representatives, 
if they wish to do so. We believe that the patient receiving services 
should be involved in the person-centered care planning process, and 
recognize that there are times when patients may want to involve other 
people in that process to assist in making decisions. Likewise, 
patients may also choose to designate another person to make all 
decisions on the patient's behalf. We believe that defining a 
``representative'' in a manner that recognizes patient choice, both in 
who the representative is and in the role that the representative will 
play, would be beneficial to patients. We also propose to explicitly 
recognize legal guardians in situations where the patient has one. If a 
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 would 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. ``In advance'' and ``supervised practical training'' 
would be defined to provide clarity for clinical care purposes.
    As discussed in detail in section III.D.4 of this preamble, we are 
proposing modifications to the current personnel qualifications 
requirements. Therefore, we would not retain the provisions of current 
Sec.  484.4, ``Personnel qualifications,'' under proposed subpart A, 
General Provisions. These modifications would be set forth under 
proposed Sec.  484.80, ``Home health aide services,'' and proposed 
Sec.  484.115, ``Personnel qualifications.''
    We are also proposing 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 Outcome and Assessment Information 
Set (OASIS) Information (Proposed Sec.  484.40)
    At Sec.  484.40, we propose 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 propose to include most of the current requirements 
of Sec.  484.20, which relate to the electronic reporting of the OASIS 
data. We propose to replace the current 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. This requirement does not reflect current technology; 
therefore, we believe that it is no longer appropriate. Instead, we 
propose 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 propose to re-designate and modify the patient 
rights provisions that are found at current Sec.  484.10. Section 
1891(a)(1) of the Act states a HHA must protect and promote the rights 
of each individual under its care. Currently, the patient rights 
provisions are organized into the following six standards: (1) Notice 
of rights; (2) Exercise of rights and respect for property and person; 
(3) Right to be informed and to participate in planning care and 
treatment; (4) Confidentiality of medical records; (5) Patient 
liability for payment; and (6) the Home Health hotline.
    In this rule, we propose to reorganize patient rights 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. While the proposed patient rights 
provisions retain much of the basic focus of the current provisions, we 
believe our proposal presents a clearer and more organized view of our 
expectation of how HHAs should promote patient rights by focusing on 
ensuring patient safety and improving patient outcomes.
    The current ``Notice of rights'' standard states only that the HHA 
must provide written notice of the patient's rights in advance of 
furnishing care, and that the HHA must maintain documentation 
demonstrating compliance. In proposed Sec.  484.50(a), we state that 
each patient and patient representative (if the patient has one), has 
the right to be informed of his or her rights in a language and manner 
the individual understands. More specifically, under proposed Sec.  
484.50(a)(1), we propose 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. 
The patient's representative, who could be a family member or friend 
who accompanies the patient, 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 representative would not need to be the patient's legal 
representative.
    If a patient is unable to effectively communicate directly with HHA 
staff, then the HHA may effectively communicate patient rights 
information to the patient's representative. Communications with the 
representative would be required to be

[[Page 61169]]

in the representative's primary or preferred language and in a manner 
that he or she can understand. Whether communicating with a patient or 
representative, HHA staff would be required to provide language 
assistance services or auxiliary aids and services at no cost, and 
provide notice of the availability of assistance, when necessary, to 
ensure effective communication between patients, representatives, and 
HHA staff. We note that the requirement to provide assistance and aids 
already exists as part of relevant statutes (for example, Title VI of 
the Civil Rights Act of 1964) and the regulations that implement these 
statutes (see 45 CFR parts 480, 405, and 490), and that HHAs agree to 
abide by these regulations as part of the provider agreement that they 
sign in order to participate in Medicare (see 42 CFR part 489). 
Compliance with the existing statutes, regulations, and sub-regulatory 
guidance documents would satisfy the intent of this proposed provision.
    If the patient or representative prefers using an interpreter of 
his or her own, he or she may do so. The HHA must ensure that the 
communication via the interpreter of choice is effective. HHAs may wish 
to document the offer and refusal of a professional interpreter in the 
patient's clinical record as evidence of compliance with the 
requirements of this section. A professional interpreter is not 
considered to be a patient's representative. Rather, it is the 
professional interpreter's role to pass information from the HHA to the 
patient.
    We also propose to require that the patient be provided a written 
copy of the patient rights information. This could be provided in 
English or in the patient's primary or preferred language for present 
or future reference. 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 have 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.
    While we propose these requirements under the authority of sections 
1861(o) and 1891 of the Act, Title VI of the Civil Rights Act of 1964 
(42 U.S.C. 2000d et seq.) and Section 504 of the Rehabilitation Act of 
1973 also apply to HHAs, as well as other health care providers. Our 
proposed requirement has been designed to be compatible with guidance 
related to title VI of the Civil Rights Act of 1964. The Department of 
Health and Human Services' (HHS) guidance related to Title VI, 
``Guidance to Federal Assistance Recipients Regarding Title VI 
Prohibition Against National Origin Discrimination Affecting Limited 
English Proficient Persons'' (August 8, 2003, 68 FR 47311) applies to 
those entities that receive federal financial assistance from HHS, 
including HHAs that participate in Medicare and Medicaid. This guidance 
may assist HHAs in ensuring that patient rights information is provided 
in a language and manner the patient understands.
    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 so 
that patients and caregivers can ask questions about the care being 
provided.
    We are also proposing 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. The OASIS privacy notice would inform the 
patient why the OASIS information was being collected and describe the 
rights of the patient regarding the collection of this information. The 
OASIS privacy notice is available in English and Spanish, and can be 
found at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/OASIS/Regulations.html. Use of the OASIS Privacy 
Notice is required by the Federal Privacy Act of 1974, and must be 
used, in addition to other notices that may be required by other 
privacy laws and regulations. There is additional discussion of the use 
of the OASIS Privacy Notice in the Dec. 23, 2005 rule (70 FR 76199, 
76201), where we referred to a variety of provisions governing the 
privacy and security of the Federal automated information systems.
    Finally, at Sec.  484.50(a)(4), we would require that the HHA 
obtain the patient's or representative's signature confirming that he 
or she has received a copy of the notice of rights and 
responsibilities.
    The current standard at Sec.  484.10(b) sets out requirements for 
the exercise of patient rights and respect for property and person as 
one standard. We have stressed the importance of these two individual 
concepts by proposing to separate the requirements into 2 standards at 
Sec.  484.50(b), ``Exercise of rights'' and at Sec.  484.50(c), 
``Rights of the patient.'' Under proposed Sec.  484.50(b), 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. We propose these provisions in recognition 
of the complexities of representation. There are many circumstances 
under which representatives may be used, and the extent of such 
representation varies from one patient to another. Some patients may 
require total representation because they are unable to communicate and 
advocate for themselves. Others may be able to participate in their 
care to a certain degree and require representation as a supportive 
mechanism. Still other patients may wish to hand off decision-making 
and advocacy responsibilities to another person even though these 
patients are fully capable of fulfilling this role themselves. Our goal 
is to provide guidance to HHAs regarding how to address these 
situations and intricacies in the most patient-centered, patient-
directed way possible. We specifically seek public comment on ways to 
assure that patient choice is respected and upheld, while also 
balancing the need to assure patient safety.
    Proposed Sec.  484.50(c) would set forth the explicit rights of 
each home health patient. At Sec.  484.50(c)(1), we propose 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 propose 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. If an injury of unknown source is 
identified, we would expect the HHA to investigate the injury in order 
to determine its cause and take action to prevent further injuries 
related to that source. 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 or refuse care.

[[Page 61170]]

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. We expect 
that this assessment would focus on goals and preferences that are 
specific to the delivery of home health care. Additionally, each 
patient would have the right to participate in and be informed about 
the care that the HHA will furnish 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 to be kept in his or 
her home, 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 would 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 propose 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). In 
order to maintain confidentiality within the patient's home, as we are 
proposing at Sec.  484.50(c)(4)(iii), we would expect an HHA to educate 
a patient and family about how to store the copy of the patient's plan 
of care in the patient's home.
    Proposed Sec.  484.50(c)(7), would retain the requirements of the 
current standard at Sec.  484.10(e), Patient liability for payment. 
Patients would be informed about which services would be covered, which 
services might or might not be covered, and the patient's 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 propose 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.
    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 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).
    At proposed Sec.  484.50(c)(8), we would retain the basic concept 
of the requirement at current Sec.  484.10(e) regarding patient payment 
liabilities. 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 propose to revise this 
current requirement by cross-referencing the regulations regarding 
expedited reviews, found at 42 CFR part 405, subpart J. These 
requirements protect patients from unexpected bills for usually covered 
care, which may not be covered by Medicare in a particular instance, 
and ensures patient access to the expedited review process.
    We would retain the current standard found at Sec.  484.10(f), 
regarding the home health hotline at proposed Sec.  484.50(c)(9). The 
home health hotline provides an important avenue for patients to 
register complaints against, or pose questions about, an HHA. Patients 
would still retain the right to be informed of the availability of the 
toll-free home health hotline in their state, including the telephone 
number and the hours of operation. The 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. HHAs should select agencies that have a public 
service mission and provide assistance free of charge, such as area 
Agencies on Aging, Aging and Disability Resource Centers, legal service 
programs, State Health Insurance Programs, and Adult Protective 
Services. HHAs would have the discretion to select, for inclusion in 
the list, those local agencies and organizations that are likely to be 
most appropriate for the needs of each HHA's unique patient population.
    We also propose 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, such as those advocacy and protection agencies described above. 
Examples of discrimination or reprisal may include a reduction of 
current services or a complete discontinuation of services and 
discharge from the HHA.
    Finally, we propose 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 believe that making auxiliary aids and language 
services available to patients, to facilitate an understanding of their 
rights and to facilitate the provision of care throughout the care 
planning and care delivery process will improve the quality and 
effectiveness of the care that is delivered, and will improve the 
patient's experience of care as a whole.
    We propose 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. This proposed standard would list the criteria by which an 
HHA could discharge or transfer a patient. The proposed criteria are 
designed to help prevent the untimely discharge of home health patients 
and ensure that patients are discharged or transferred only under 
appropriate circumstances. This proposed standard would require that 
the HHA inform its patients of its policies governing admission, 
transfer, and discharge in advance of the HHA providing care. Under 
this proposed standard, an HHA could only transfer, discharge, or 
terminate care for the following reasons: (1) When 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) 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; (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

[[Page 61171]]

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. There are no regulations in the current CoPs that 
address these issues. However, this provision is consistent with the 
decision in Lutwin v. Thompson 361 F.3d 146 (2nd Cir. 2004) regarding 
the provision of notice when services are reduced or terminated.
    Likewise, although current CMS guidance (Pub. L. 100-02, Chapter 7, 
Section 10.10, Discharge Issues) allows discharge for cause, there are 
no regulations in the current CoPs that address these issues. We are 
proposing to add Sec.  484.50(d)(5) to permit discharge for cause if 
the patient's (or other persons in the patient's home) behavior is so 
disruptive, abusive, or uncooperative that the delivery of care to the 
patient or the ability of the HHA to operate effectively and safely is 
seriously impaired. Before discharging a patient for cause, the HHA 
would be required to advise the patient, the representative (if any), 
the physician who is responsible 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 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 propose that the HHA would be required to provide the 
patient and representative (if any), with contact information for other 
agencies or providers who may be able to provide care following the 
discharge. 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.
    Given the vulnerability of home health patients and in the interest 
of patient safety, we propose a standard at Sec.  484.50(e), 
``Investigation of complaints,'' that would expand upon the current 
complaint investigation requirements at Sec.  484.10(b)(5). Proposed 
Sec.  484.50(e)(1)(i) would require the HHA to investigate complaints 
made by patients, representatives, caregivers, and families regarding 
treatment or care that is (or fails to be) furnished, is furnished 
inconsistently, or is furnished 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/or misappropriation of patient property 
by anyone furnishing services on behalf of the HHA. This requirement 
would clarify that all patient complaints should be investigated by 
HHAs. 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. We believe that HHAs should be permitted the flexibility 
to establish their own policies and procedures for documenting and 
resolving complaints, and we would expect HHAs to consistently adhere 
to these policies and procedures.
    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 administrator 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. Since HHA staff is in a unique position to recognize signs of 
patient abuse in the home, this proposed requirement would serve to 
further ensure the health and safety of home health patients. 
``Appropriate authorities'' may include, but are not limited to, state 
and local law enforcement, health care ombudsmen, and State survey 
agencies.
    To address effective communication with patients who are LEP or 
have disabilities, we are proposing a new standard at Sec.  484.50(f), 
``Accessibility.'' We propose that information that is provided to 
patients would be provided in plain language, and in a manner that is 
both accessible and timely to the individual. For people with 
disabilities, providing access includes the use of accessible Web sites 
and the provision of auxiliary aids and services, such as qualified 
interpreters and alternate formats. For persons with LEP, providing 
access includes providing oral interpretation and written translations.
4. Comprehensive Assessment of Patients (Proposed Sec.  484.55)
    We propose to retain the majority of the substantive requirements 
of current Sec.  484.55, with significant reorganization. We propose to 
retain the requirement that each patient be required to receive a 
patient-specific comprehensive assessment. We also propose 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 propose 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 propose 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 propose new content requirements, such as an 
assessment of psychosocial and cognitive status, which we believe would 
provide for a more holistic patient assessment. We propose 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, functional, 
and cognitive 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;
     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; and
     The patient's representative (if any).
    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 propose to retain the majority of the content of the 
requirements of current Sec.  484.55(d), with one change. Currently 
Sec.  418.55(d)(2) generally requires that an update of the 
comprehensive assessment must be completed within 48 hours of a patient 
returning home after a hospital admission. This fixed requirement does 
not allow ordering physicians to modify the time frame for the HHA to 
resume

[[Page 61172]]

its care. We believe that it is in the best interest of patients to 
allow for more physician discretion so that physicians can tailor the 
resumption of home health care to the specific needs of a patient. 
Therefore, we propose to revise Sec.  484.55(d)(2) to allow for a 
physician-ordered resumption of care date as an alternative to the 
fixed 48 hour time frame.
5. Care planning, Coordination of Services, and Quality of Care 
(Proposed Sec.  484.60)
    Current regulations concerning the plan of care are set forth at 
Sec.  484.18, ``Acceptance of patients, plan of care, and medical 
supervision.'' We propose to revise that requirement, as well as 
current Sec.  484.14(g), ``Coordination of patient services,'' by 
creating 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. We propose five standards under this CoP, 
which we believe reflect and encourage the interdisciplinary approach 
to home health care delivery. We would reorganize the current standards 
to place the events in the care planning process in sequential order: 
(1) Plan of care at Sec.  484.60(a); (2) conformance with physician 
orders at Sec.  484.60(b); (3) review and revision of the plan of care 
at Sec.  484.60(c); (4) coordination of care at Sec.  484.60(d); and 
(5) discharge or transfer summary at Sec.  484.60(e).
    In this CoP, we propose to require 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. A copy of 
this individualized plan would be provided to each patient and 
representative (if any), in accordance with the proposed patient rights 
requirements at Sec.  484.50(c)(4)(iii). We believe that providing each 
patient with a copy of his or her plan of care will improve HHA-patient 
communications and enable patients to more thoroughly understand the 
care that they are to receive. We also believe that part of providing 
this information is teaching patients and their families how to protect 
the information in order to ensure their right to a confidential 
record, as would be required in proposed Sec.  484.50(c)(6). The 
individualized plan of care would be revised or added to at intervals 
as necessary to continue to meet patient care needs.
    We also propose that the plan of care include the patient-specific 
measurable outcomes which the HHA anticipates would result from its 
implementation. As described in proposed Sec.  484.50(c)(4), the 
patient has the right to participate in his or her care planning, 
including the establishment of goals and outcomes of care. We would 
expect the plan of care to be reflective of the improvement, 
maintenance, and/or prevention goals and outcomes specific to each 
patient's condition. As noted in a recent update to the Medicare 
Benefit Policy Manual (CR 8458, http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R179BP.pdf), consistent with 
the settlement agreement in the case of Jimmo v. Sebelius, 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. All 
services furnished by the HHA for all purposes would be provided in 
accordance with accepted standards of practice.
    Under proposed Sec.  484.60(a)(1), Plan of care, we propose 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. 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, would provide a basis for the development 
of the optimal plan of care and goals. Patients participating in the 
shared decision-making model, where there is a mutually respectful 
exchange that recognizes the individuality of the patient and a process 
in which responsibility is divided among the patient, physician, and 
agency acting on physician orders, will better understand the goals of 
treatment. These patients are more likely to actively participate in 
the treatment process and achieve better treatment outcomes. (``A 
typology of preferences for participation in healthcare decision 
making,'' http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1637042) The shared decision making model has 
been embraced in literature (``Decision-making in the physician-patient 
encounter: revisiting the shared treatment decision-making model'', 
http://www.sciencedirect.com/science/article/pii/S0277953699001458; 
``Four Models of the Physician-Patient Relationship,'' JAMA (1992).; 
``Physician Recommendations and Patient Autonomy: Finding a Balance 
between Physician Power and Patient Choice,'' http://annals.org/article.aspx?articleid=710110), and the Institute of Medicine has 
recommended including it in medical school curricula as a mechanism to 
improve care (Institute of Medicine, ``Improving Medical Education: 
Enhancing the Behavioral and Social Science Content of Medical School 
Curricula'' (2004)) (See also brown.edu/.../Mod2SharedDecMaking/Teachingmats/Handout1SDMDefined.doc). This standard would require that 
each patient's home health services be furnished under a written, 
patient-specific plan of care that would identify patient-specific 
measurable outcomes and goals selected jointly by the HHA and the 
patient.
    We are soliciting public comments regarding methods to engage 
patients and the physicians who are responsible for their plans of care 
in the care planning and management process. Specifically, we are 
interested in ways to maximize the level of involvement of the 
physician who is most involved in the patient's care prior to admission 
to the home health agency, and who is responsible for overall treatment 
of the condition(s) that led to the need for home health care. We 
believe that the continual involvement of physicians may facilitate 
better transitions of care, improve patient outcomes, and reduce acute 
care admissions by clearly establishing (and updating) treatment goals 
and plans, and effectively delivering care that meets those goals. We 
are also interested in ways to facilitate communication between the HHA 
and other physicians and practitioners (such as nurse practitioners and 
physician assistants) who may be furnishing care for issues that are 
not directly connected to the issues being addressed by the HHA. 
Additionally, we are interested in ways

[[Page 61173]]

to facilitate communication with those physicians and practitioners who 
will be responsible for managing the patient's care after the patient 
is discharged from the HHA. We believe that actively soliciting input 
from these clinicians may help improve the transitions into and out of 
home health care.
    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. We note that it is important for HHAs to 
consider the social determinants that may contribute to poor health 
outcomes, as many current approaches to prevention, treatment, and 
disease control are limited to an individual's diagnosis and related 
risk factors. There is often a lack of awareness and/or assessment of 
the factors that may enhance or create a barrier to good health 
outcomes. Factors such as low income, lack of access to a primary care 
practitioner, poor nutrition due either to poor choices and/or lack of 
availability of healthy and affordable food items (for example, ``food 
deserts''), and other environmental, social, and/or emotional issues 
may affect compliance and/or adherence with medical care and treatment. 
The HHA staff must be aware of the social and/or economic circumstances 
in which people are born, grow up, live, work, and age, as well as what 
are in place for their overall health care. This contributes to the 
HHAs ability to identify state, local, and/or federal resources the 
patient may need in order to design a holistic plan of care that may 
result in improved health outcomes, care, and treatment results. For 
example, if an elderly, low income, insulin dependent diabetic patient 
is not able to afford regular meals, the home health agency staff may 
refer to local resources such as a food bank, meals on wheels, or other 
resource. Diabetic patients must have regular meals for blood sugar 
control. Lack of awareness and intervention related to this factor may 
result in a poor outcome for the patient. The Underserved Populations 
(UP) Network provides resources, tools, and webinars for agencies via 
http://www.homehealthquality.org/UP.aspx focused on improving outcomes.
    In order to implement the individualized physician-prescribed plan 
of care, agencies often develop a discipline-oriented plan, wherein 
each specific service being provided (for example, physical therapy, 
occupational therapy, and speech-language pathology) sets out findings, 
treatment goals, and interventions planned in order to achieve those 
goals in compliance with the physician's orders.
    If HHA services are initiated following a patient's hospital 
discharge, we propose to require that the HHA must include an 
assessment of the patient's level of risk for hospital emergency 
department visits and hospital re-admission. In order to establish the 
patient's risk level, we believe that HHAs would identify the patient's 
specific risk factors. We propose 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 those 
identified risk factors that contribute to the HHA's establishment of a 
particular risk level for a patient. Resources to assist HHAs in 
assessing re-hospitalization risks are available at http://www.homehealthquality.org.
    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, a requirement that is currently set forth at Sec.  484.18(c). 
This proposed standard also would reflect the vaccination policies of 
the final rule with comment period published in the Federal Register on 
October 2, 2002 (67 FR 61808), also set forth at Sec.  484.18(c). That 
rule provided an exception from the physician order requirement for the 
administration of influenza and pneumococcal polysaccharide vaccines. 
The current requirement allows influenza and pneumococcal 
polysaccharide vaccines to be administered based on a HHA policy 
developed in consultation with a physician, and after an assessment for 
contraindications. We propose to retain this requirement at Sec.  
484.60(b)(2). Proposed Sec.  484.60(b)(4) 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 would maintain the intent of the current 
requirement at Sec.  484.18(c) by proposing at Sec.  484.60(b)(5) that 
a registered nurse (RN) or other qualified practitioner who is licensed 
to practice by the state must document the order in writing in the 
patient's clinical record, with a signature, time, and date. As 
described in the definitions section, for purposes of this rule, verbal 
orders are those physician orders that are spoken to qualified medical 
personnel. Verbal orders would also have to be recorded in the 
patient's plan of care. Reliance on a HHA to maintain physician orders 
in written form would protect patients by ensuring that the plan of 
care incorporated all services and treatments ordered by the physician 
who is responsible for the home health plan of care. If a physician 
faxed orders or otherwise transmitted them through other electronic 
methods from his or her office, those orders would be required to be 
included in the patient's clinical record and plan of care. The 
proposed rule would provide an opportunity for an HHA to establish 
policies defining who is authorized to accept physicians' verbal 
orders. The categories of practitioners identified as being authorized 
to accept physicians' verbal orders by the HHA would be required to be 
consistent with state requirements.
    We would also require, under proposed Sec.  484.60(b)(5), that 
verbal orders be authenticated, dated, and timed by the physician 
according to the HHA's internal policies and applicable state laws and 
regulations. Many states in their licensure requirements, and HHAs in 
their policies, have established timeframes for physician 
countersignature of verbal orders in accordance with the agency's risk 
tolerance, legal liability, and logistical concerns. Although 
timeframes may vary, we support state requirements and HHA flexibility 
in this regard, and do not propose a separate timeframe requirement for 
physician countersignature for verbal orders for HHA providers. In 
addition to all applicable state requirements and agency policies, HHAs 
should also be aware of CMS payment reimbursement requirements, which 
state that a final claim for each episode of care may not be submitted 
until all orders are signed.
    Under proposed Sec.  484.60(c), ``Review and revision of the plan 
of care,'' we propose that the individualized plan of care be reviewed 
and revised by the physician who is 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. While the provision would require review 
and revision at least every 60 days, we

[[Page 61174]]

expect that physicians and agency staff would communicate more 
frequently if a patient's condition warranted it. To ensure patient 
health and safety, we propose 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 propose 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. It would be the HHA's responsibility to make certain that all 
aspects of the revised plan of care were implemented.
    Furthermore, we propose 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 propose 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. We believe that 
communicating with the patient and those who will be continuing to 
furnish services to the patient after home health services are 
discontinued regarding changes related to plans for discharge prior to 
the discharge would allow time for important discussions, preparations, 
and coordination activities. We note that 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 may be a specialist, a nurse practitioner, a physician assistant, 
or another type of medical service. In proposed Sec.  484.60(d), 
``Coordination of care,'' we propose 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. 
It is our goal to support and foster collaboration and communication 
among the professional disciplines responsible for caring for a 
patient. It would be the agency's responsibility to determine the 
degree of coordination necessary to meet the needs of the patient, and 
to develop an approach that best implemented the coordination of the 
patient's care. It would also be the agency's responsibility to 
determine the most appropriate and effective way to provide evidence 
during a survey that these care coordination activities were occurring 
on a continual basis for every patient, and that the agency was 
assessing the impact of care coordination activities on patient care 
utilizing the HHA's quality assessment and performance improvement 
program, if appropriate.
    Finally, under proposed Sec.  484.60(d)(3), we propose 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. This proposed requirement is consistent with 
those in the current payment-related regulations at Sec.  409.42(c)(1). 
Ongoing patient training and education includes all periods of time 
that the patient is receiving care from an HHA, from admission through 
the day of discharge. The training would include educating the patient 
about his or her post HHA discharge care duties and the need (as 
appropriate) to follow-up with 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. The HHA 
would be required to ensure that each patient and caregiver receives 
any training necessary to achieve the patient-specific measurable 
outcomes outlined in the plan of care, which are 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.
    Under Medicare's home health benefit, when applicable, HHAs are 
expected to provide education and training to their patients. For 
instance, HHAs are expected to provide education and training to help 
insulin dependent diabetes mellitus (IDDM) patients and other diabetic 
patients self-manage their diabetes. Many homebound patients with 
diabetes require short-term management for skilled observation, 
assessment, teaching, and training activities. If the patient is unable 
to learn to self-manage, including self-administer medication, the HHA 
would be expected to provide the teaching and training to a care-giver 
or family member. We also encourage HHAs to take advantage of the help 
and support available from organizations that teach innovative 
techniques associated with diabetes self-management training (DSMT). 
Collaborating with these organizations may allow HHAs to achieve 
greater success in enabling patients and/or their caregivers to better 
achieve self-management, and may provide the HHAs with innovative care 
suggestions regarding their patients.
    At Sec.  484.60(e), Discharge or transfer summary, we propose that 
HHAs would 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 will assist in post-
discharge or transfer continuity of care, or that is requested by the 
receiving practitioner or facility.
    We propose to include these elements in the discharge or transfer 
summary to provide the clear and comprehensive summary that is 
necessary for effective and efficient follow-up care planning and 
implementation as the patient transitions from HHA services to another 
appropriate health care setting.

[[Page 61175]]

6. Quality Assessment and Performance Improvement (QAPI) (Proposed 
Sec.  484.65)
    Beginning with the 1999 Institute of Medicine (IOM) report entitled 
``To Err is Human: Building a Safer Health System,'' the focus in 
health care changed from an incident-based, after-the-fact quality 
improvement focus to a pre-emptive, proactive quality assessment and 
performance improvement focus. CMS evaluated and responded to the 
recommendations in the IOM report through a coordinated effort called, 
``Doing What Counts for Patient Safety: Federal Actions to Reduce 
Medical Errors and Their Impact.'' 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). Overall, this proposed 
QAPI CoP is consistent with the QAPI program requirements for end stage 
renal disease facilities (Sec.  494.110), hospitals (Sec.  482.21), 
hospices (Sec.  418.58), organ procurement organizations (Sec.  
486.348), and transplant centers (Sec.  482.96).
    We believe that the proposed QAPI CoP would provide an opportunity 
for HHAs to develop a program that would enable them to identify areas 
for improvement which would help to ensure quality care and patient 
safety. In addition, we are emphasizing that the HHA would be required 
to take actions to prevent and reduce medical errors as part of their 
overall QAPI program. 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.
    The current CoPs rely on a problem-oriented, external, after the 
fact (occurrence) approach to resolve patient care issues. The proposed 
QAPI CoP would require proactive performance monitoring through an 
effective, ongoing, agency-wide, data-driven QAPI program that is under 
the supervision of the home health agency governing body.
    In proposed Sec.  484.65(a), ``Program scope,'' we propose 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 propose, at Sec.  484.65(b), ``Program data,'' that a 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 a 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 propose that the HHA's 
governing body would be responsible for approving the frequency of, and 
level of detail to be used in data collection. This level of 
flexibility would allow HHAs to establish data collection and analysis 
policies and procedures that reflect currently accepted standards and 
practices.
    At Sec.  484.65(c), Program Activities, we would require a 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 propose 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 propose 
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.
    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. High-
risk and high-volume areas will vary based on a HHA's patient 
population and other unique characteristics. For example, wound care 
could be a high-risk area for a HHA because the HHA does not perform 
the care very often, and thus may not be up-to-date on the latest 
techniques. Likewise, wound care could be a high-volume area for 
another HHA with a large number of patients requiring wound care 
services, increasing the likelihood of a problem occurring due to the 
sheer number of wound care visits that would occur. Data gathered 
either through the OASIS data set or through other measurement data 
collection tools, and subsequent analysis of the data, would be used to 
identify these areas. Within this standard, we also propose 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. In the opening paragraph of Sec.  484.65 we also propose to 
require the HHA to maintain documentary evidence of its QAPI program 
and to demonstrate its operation to CMS during the survey process.
    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 propose that the governing body establish clear 
expectations for patient safety. We also propose that the governing 
body would appropriately address any findings of fraud or waste in 
order to assure that

[[Page 61176]]

resources are appropriately used for patient care activities and that 
patients are receiving the right care to meet their needs.
    We believe small and mid-size HHAs would be able to effectively 
implement this condition as easily as larger HHAs. The proposed QAPI 
CoP would provide HHAs with enough flexibility to implement the quality 
assessment and performance improvement process without inordinate 
expenditure of capital or human resources. An HHA could also use 
outside resources to assist in development and support of its QAPI 
program. Each HHA's QAPI program should be individualized to reflect 
the size, scope, and complexity of its services and patient population. 
Therefore, we do not believe there is a need to differentiate our 
expectations for QAPI between small-to-mid-size HHAs and larger HHAs.
    We have also chosen not to be prescriptive in this requirement 
because every HHA is different, and mandating ``a one-size-fits-all,'' 
process-oriented quality assessment and performance improvement program 
would not be beneficial to the patients or the HHA. Each HHA would be 
expected to conduct its QAPI program in a way that best meets its needs 
and the needs of that HHA's patients. HHAs would be able to utilize 
data from the OASIS data set through the risk-adjusted outcome-based 
quality improvement (OBQI), outcome-based quality management (OBQM), 
and process based quality improvement (PBQI) reports. Case-mix-adjusted 
outcome reports give agencies a ``snapshot'' of their individual 
agency's performance. The OASIS data set provides much of the necessary 
data items for CMS and HHAs to measure outcomes, potentially avoidable 
events, and patient/agency risk adjustment factors and for CMS to 
generate OBQI, OBQM, and PBQI reports. (The Outcome-Based Quality 
Improvement (OBQI) Manual (September 2002) and CASPER Reporting 
Application are located in the download section of CMS' HHQI OASIS OBQI 
Web page at http://www.cms.gov/HomeHealthQualityInits/16_HHQIOASISOBQI.asp#TopOfPage and http://www.cms.gov/HomeHealthQualityInits/18_HHQIOASISOBQM.asp#TopOfPage. The PBQI Manual 
(May 2010) is located in the ``downloads'' section of CMS'OASIS PBQI/
Process Measures Web page section at http://www.cms.gov/HomeHealthQualityInits/15_PBQIProcessMeasures.asp#TopOfPage). The OBQI, 
OBQM, and PBQI reports can be used to assess the quality of care at 
HHAs and provide information to assist them in ongoing quality 
improvement.
    In addition to these resources, there are other existing resources 
already in place through http://www.homehealthquality.org that support 
issues addressed in this proposed CoP. The Home Health Quality 
Initiative (HHQI) is part of the Quality Improvement Organization 
program established by CMS. Established in 2007, its goal is to improve 
the quality of home care services patients receive as measured by 
improvement in selected publicly reported and other clinical measures. 
Participation in the HHQI is free to all Medicare-participating HHAs. 
Participating HHAs have access to many resources that may aide in their 
QAPI efforts, such as best practice intervention packages that offer 
practical applications of quality improvement strategies to improve 
performance, individualized data reports via a secure online portal to 
assist with measuring progress, networking and educational 
opportunities via webinars scheduled at least monthly, and prompt 
assistance to address needs and questions. In particular, the HHQI 
provides resources related to falls prevention, flu and pneumonia 
vaccinations, oral medication management, and patient self-management.
    Through the survey process, we intend to assess whether HHAs have 
all of the components of a QAPI program in place. Surveyors would 
expect HHAs to demonstrate, with the objective data from the OASIS data 
set and other sources available to the HHA, that improvements had taken 
place with respect to actual care outcomes, processes of care, patient 
satisfaction levels and/or other quality indicators. Additionally, 
surveyors would expect the HHA to demonstrate that all disciplines are 
involved in its QAPI program, consistent with the requirements of 
proposed Sec.  484.75(c), below.
    We believe that physician involvement in efforts to improve the 
outcome of patient care is vital and, as previously noted, we have 
addressed this issue by proposing the physician involvement requirement 
at proposed Sec.  484.60, ``Care planning, coordination of services, 
and quality of care.'' We have also addressed this issue by requiring 
all HHA skilled professionals, which would include physicians employed 
by or under contract with the HHA, to participate in the HHA's QAPI 
program (see proposed Sec.  484.75). Likewise, we encourage each HHA to 
consider the voluntary input of physicians who are not employed by or 
under contract with the HHA in designing, implementing, and evaluating 
its QAPI program. Physicians not employed by or under contract with the 
HHA may be in a unique position to provide a HHA's management and care 
delivery team with structured feedback and insight on ways that 
performance could be improved. We believe it would be overly burdensome 
and beyond the scope of these regulations to require non-employee and 
non-contract physicians to participate in specific QAPI activities. 
However, in developing an effective QAPI program, HHAs have found that 
including a physician in the planning and organization phase has helped 
to focus and refine the QAPI program.
7. Infection Prevention and Control (Proposed Sec.  484.70)
    In the current HHA CoPs, there is no requirement for an HHA-wide 
infection control program; however the current regulation at Sec.  
484.12(c) states that the HHA and its staff must comply with accepted 
professional standards and principles that apply to professionals 
furnishing services in an HHA. Infection control practices are part of 
accepted professional standards and principles, and thus should not be 
new to HHAs. We are proposing to establish a new CoP at Sec.  484.70, 
``Infection prevention and control,'' because we believe that it is 
appropriate to address this important issue as a distinct part of the 
regulatory process. We would organize this new condition under the 
following three standards: (1) Prevention, (2) control, and (3) 
education.
    The effects of infectious and communicable diseases on patient 
health are significant. In response to this issue, the health care 
industry developed guidelines and recommendations for managing 
infection control programs that include health care settings. 
(``Requirements for infrastructure and essential activities of 
infection control and epidemiology in out-of-hospital settings: A 
Consensus Panel report'' Association of Professionals in Infection 
Control (APIC) and the Society for Healthcare Epidemiology of America 
(SHEA), American Journal of Infection Control 27 (1999)) Additionally, 
accreditation organizations such as the Joint Commission responded to 
the issue of infection control by designing new infection control 
standards for, among others, home care providers. Other accrediting 
bodies have also chosen to include infection control requirements in 
their home care standards as well. Because of the negative impact on

[[Page 61177]]

patient health and safety posed by infectious and communicable 
diseases, and the significant amount of attention generated by this 
issue, we believe that HHAs need to address infection prevention and 
control in a more comprehensive manner.
    We recognize that a HHA cannot be entirely responsible for the 
maintenance of a completely infection-free environment in an 
individual's home (where there are variables beyond the control of the 
HHA). However, by following ``current best practices'' (for example, 
following the standard precaution of wearing gloves when handling blood 
or blood products) in implementing the plan of care, the potential 
risks of infectious and communicable diseases can be greatly reduced 
for patients, families, and staff. We propose 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. (Also see ``Definitions for 
Surveillance of Infections in Home Health Care,'' February 2008, http://www.apic.org/AM/Template.cfm?Section=Search&section=Surveillance_Definitions&template=/CM/ContentDisplay.cfm&ContentFileID=9898.) Many states have rules 
requiring reporting of certain communicable diseases to the department 
of health. In turn, the department of health typically conducts 
investigations. We would expect HHAs to work in conjunction with their 
respective health departments, who work in conjunction with the CDC, 
when developing and implementing their programs.
    Additionally, under this proposal, the program would be expected to 
be an integral part of the agency's QAPI program. As part of the QAPI 
program, the infection prevention and control program would identify 
infectious and communicable disease problems that affect the provision 
of home health services, track patterns and trends, establish a 
corrective plan, and monitor for improvement and effectiveness of 
corresponding interventions.
    Because infection prevention and control education is crucial to 
preventing the spread of communicable diseases, we are proposing 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. This could be accomplished through in-service 
training for staff, and through the use of printed material, 
instructional videos, and in-home demonstration for patients and their 
families/caregivers. The training provided to patients and caregivers 
should be specific to their individual needs, such as safe practices 
for performing assisted monitoring of blood glucose as part of typical 
diabetes management. (See Infection Prevention during Blood Glucose 
Monitoring and Insulin Administration at http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html). The exact content and 
frequency of staff, patient, and caregiver education would be left to 
the discretion of individual HHAs, as established in their policies and 
procedures.
    The proposed condition would allow the HHA flexibility in meeting 
its prevention, control, and education standards. For example, the 
amount of staff education time needed for infection control would 
depend on both staff experience and the patient population. While we 
would expect ``current best practices'' to be followed, we are not 
proposing any specific approaches to meeting this requirement; readers 
should visit the CDC Web site at http://www.cdc.gov/HAI/settings/outpatient-care-guidelines.html for more information about core 
infection control practices that apply to all outpatient health care 
settings.
    We believe that this proposed infection control CoP follows, and is 
consistent with, the functions of infection control as defined in the 
APIC/SHEA Consensus Panel report. The report recommended that health 
care providers intervene directly to prevent infections; obtain and 
manage critical data and information, including surveillance for 
infections; develop and recommend policies and procedures; and educate 
and train health care workers, patients, and nonmedical caregivers. 
Further, we believe that the three-pronged approach of prevention, 
control, and education, as outlined in the proposed standards under 
this CoP, would accomplish the three principal goals of infection 
control as presented in the Consensus Panel report. These three goals 
are: (1) Protect the patient; (2) protect the health care worker (and 
others in the health care environment); and (3) accomplish the previous 
two goals in a manner that is timely, efficient, and cost-effective 
whenever possible. By maintaining an effective infection prevention and 
control program that is also an integral part of a QAPI program, a HHA 
would provide clear evidence of its efforts to minimize the spread of 
infectious and communicable diseases.
8. Skilled Professional Services (Proposed Sec.  484.75)
    This proposed new condition would consolidate and revise current 
conditions at Sec.  484.30, ``Skilled nursing services''; Sec.  484.32, 
``Therapy services''; and Sec.  484.34, ``Medical social services''; 
and set forth the requirements for skilled professional services. 
Instead of specifically identifying tasks, we would broadly describe 
the expectations of the skilled professionals who participate in the 
interdisciplinary team approach to home health care delivery. 
Specifically, we would reduce the regulation's focus on administrative 
agency process requirements and shift the focus to outcomes of care. 
Skilled professionals, within this context, would provide services to 
HHA patients directly as employees of the HHA or under a contractual 
agreement. We propose that skilled professionals actively participate 
in the coordination of all aspects of care where appropriate. By doing 
so, they would become more aware of the need to function as part of an 
interdisciplinary team.
    We have organized this proposed condition into three areas: (1) 
Provision of services by skilled professionals; (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. This is consistent with the 
description of the home health services under the hospital insurance 
benefits at part 409, subpart E. 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 propose 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);

[[Page 61178]]

     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.

We believe that an interdisciplinary approach is crucial for meeting 
the needs of home health patients.
    In addition to the requirements for licensed professional services 
described above, we propose to include a requirement governing the 
supervision of skilled professional assistants at Sec.  484.75(c). This 
would require a RN identified by the HHA to supervise the care provided 
by nurses such as licensed vocational nurses and licensed practical 
nurses. We also propose 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 MSW-prepared social worker who meets the 
requirements of Sec.  484.115.
9. Home Health Aide Services (Proposed Sec.  484.80)
    Section 1891(a)(3)(D) of the Act requires the Secretary to 
establish minimum standards for home health aide training and 
competency evaluation programs. Section 1861(m)(4) of the Act requires 
Medicare-covered home health aide services to be furnished only by 
individuals who have successfully completed a training program approved 
by the Secretary. Currently, the CoP concerning home health aide 
services is set forth at Sec.  484.36. In this rule, we propose to 
retain the current requirements while making clarifying and 
organizational changes to Sec.  484.36. As part of our reorganization, 
this revised condition would be re-located at proposed Sec.  484.80.
    We also propose to incorporate into this new CoP the provisions 
concerning the qualification requirements for becoming a home health 
aide, currently located at Sec.  484.4. In this proposed rule, these 
requirements would now be organized as nine standards under proposed 
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.
    As noted above, provisions concerning the qualifications for home 
health aides are set forth at current Sec.  484.4, Personnel 
qualifications. We believe these specific qualifications would be more 
appropriately located in the section covering home health aide 
services. 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 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 (State review and approval of nurse aide training 
and competency evaluation programs) 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).
    In light of the high turnover rate within the home health aide work 
force, we believe that flexibility in qualification requirements would 
enable HHAs to recruit qualified aides from a wider pool of employee 
prospects. While the duties of nurse aides and home health aides are 
quite similar, the main difference is the environment in which the 
aides perform the services. An agency's internal policies and 
procedures would govern the home health aide orientation training to 
reflect the differences in duties, and the environments in which the 
duties are performed. HHAs would be free to add additional aide 
training requirements as desired in order to address any specialized 
needs within the HHA's patient population (for example, additional 
skills related to dealing with pediatric patients for HHAs that have 
pediatric programs).
    Under proposed Sec.  484.80(a)(2), we would retain the intent of 
the current requirement at Sec.  484.4, and specify when a home health 
aide is deemed to have completed a program (as specified in proposed 
Sec.  484.80(a)(1) above). 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).
    In this rule, we propose to retain the requirements for content and 
duration of training from current Sec.  484.36(a). However, we have 
clarified this section. We propose, at Sec.  484.80(b), to set forth 
the requirements for training content and its duration, training 
methods (classroom and practical), and training documentation. Proposed 
Sec.  484.80(b)(1) and (2) regarding home health aide classroom and 
practical training instructor and duration requirements would be the 
same as in the current rule. The current regulation at Sec.  484.36(a) 
contains provisions regarding qualifications for instructors of home 
health aide training and specifies which organizations are eligible to 
provide training. We would retain and reorganize these two provisions 
into two separate standards at Sec.  484.80(e) and Sec.  484.80(f), 
respectively. In addition, we would remove the definition for 
``supervised practical training'' which appears in the current 
standard, and move it to a more appropriate place under Sec.  484.2, 
Definitions.
    The current requirement at Sec.  484.36(a)(1)(i) requires that 
``communication skills'' be part of the content of training for home 
health aides. Since home health aides are members of the 
interdisciplinary team and often visit a patient multiple times each 
week, they are in a position to observe changes in a patient's status 
and note the needs that are crucial and relevant to future treatment 
decisions for that patient. As such, home health aides should be able 
to report and document these changes in an appropriate manner to ensure 
that observations of a patient's status are described accurately to 
ensure optimal care. Therefore, in this proposed rule,

[[Page 61179]]

we would require at Sec.  484.80(b)(3)(i) that communication skills 
include the aide's ability to read, write, and verbally report clinical 
information to patients, representatives, and caregivers, as well as to 
other HHA staff. The intent of this proposed change is to ensure that 
home health aides would be able to communicate effectively with 
patients, caregivers, and HHA staff. We would not specify the primary 
language for employees of HHAs because we recognize that many languages 
may exist within a community. However, we believe that it is important 
that the HHA attempt to match patients with staff relative to their 
abilities to communicate with one another.
    We propose to add a new skill requirement related to recognizing 
and reporting changes in skin condition, including pressure ulcers. 
Home health aides are often the staff members who have the most 
frequent in-person contact with patients, and are therefore more likely 
to be in a position to notice changes in skin condition and early stage 
pressure ulcers. Early identification and reporting by home health 
aides would enable early intervention by the HHA to treat and reverse 
such changes. We believe that this early intervention would be 
beneficial to patients.
    At Sec.  484.80(b)(4), we propose to retain the current provision 
at Sec.  484.36(a)(3) with minor revisions. This provision would 
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. Similarly, we propose to retain the 
HHA documentation requirement currently set out at Sec.  484.36(b)(5), 
which requires the HHA to document that the requirements for both the 
competency evaluation and in-service training have been met. However, 
as noted above, we are now proposing to reorganize the current standard 
at Sec.  484.36(b) into two separate standards, Sec.  484.80(c) 
Competency evaluation, and Sec.  484.80(d) In-service training. 
Therefore, we propose to incorporate a documentation provision, which 
would require the HHA to document that the requirements of the standard 
have been met.
    We propose to address various requirements for the competency 
evaluation of home health aides in Sec.  484.80(c). We propose 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.
    As noted in the previous section, we propose to better define the 
term ``communication skills,'' and would now require communication 
training as part of the home health aide training program (Sec.  
484.80(b)(3)(i)). We also propose to include this skill among the 
subject areas which would be evaluated by observation of the home 
health aide performing the tasks.
    An effective way to assess aide competency is by observing the 
performance of the aide with a patient. Direct observation of the aide 
providing services to a patient would provide assurance that the aide 
has knowledge and understanding of the task at hand. We believe it 
would be acceptable to conduct aide training on a mannequin, and to 
conduct a competency evaluation on a ``pseudo-patient.'' However, the 
pseudo-patient for the competency evaluation would have to be an 
individual, such as another aide or volunteer, whose age is 
representative of the primary population served by the HHA. The 
following skills would be evaluated: Communication skills, reading and 
recording vital signs, personal hygiene techniques, safe transfer 
techniques, and normal range of motion and positioning criteria 
(specified under paragraphs (b)(3)(i), (b)(3)(iii), (b)(3)(ix), 
(b)(3)(x), and (b)(3)(xi)). The skills would be evaluated by observing 
the aide's performance carrying out the task with a patient or 
volunteer. The task would be required to be carried out to completion 
to assure that the aide was capable of performing tasks thoroughly, 
correctly, and independently. In accordance with proposed Sec.  
484.80(c)(2), the competency evaluation described in this paragraph may 
be offered by any organization, except an HHA that has been subject to 
certain corrective actions as described in proposed paragraph (f) of 
this section.
    Section 484.80(c)(3) would maintain the current requirement that a 
RN must perform the competency evaluation. In addition to the RN, we 
are now proposing that the competency evaluation be done in 
consultation with other skilled professionals, as appropriate, since we 
believe it is essential that a home health aide's competency be 
demonstrated in each specific task performed. However, we continue to 
believe that it is necessary that a RN actually perform the competency 
evaluation. Since we depend upon a RN to provide the foundation of home 
health aide training, it is necessary to use a RN to evaluate the 
skills learned in that training.
    This rationale for the use of a RN in performing the competency 
evaluation is also the basis for the proposed change to the current 
regulation at Sec.  484.36(b)(4)(i), which requires 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 a RN) until he or 
she achieves an evaluation of ``satisfactory.'' We would modify this 
requirement at Sec.  484.80(c)(4) by requiring that the task be 
performed under the supervision of a RN, not a licensed practical 
nurse.
    In the current rule, at Sec.  484.36(b), the provisions regarding 
in-service training and competency evaluations of home health aides are 
combined. We believe that these requirements should be separated into 
two standards: Competency evaluation, as discussed above, at proposed 
Sec.  484.80(c), and in-service training at proposed Sec.  484.80(d). 
Creating two standards would emphasize the importance of each of these 
areas. 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. We continue to believe that 
requiring 12 hours of training in a 12-month period would not place an 
unreasonable burden on the resources of the organization furnishing the 
training. Using the 12-month period would allow HHAs considerable 
flexibility in scheduling and in providing training. We would expect 
that the start dates for the 12-month in-service training period would 
be the aides' dates of hire or calendar year, as defined by the HHA.
    The proposed requirements for the home health aide competency 
evaluation discussed above, when coupled with this proposed requirement 
for in-service training, as well as ongoing aide supervision (as 
proposed in Sec.  484.80(h)), would provide an environment conducive to 
safe and appropriate patient care. Further, by continuing to emphasize 
ongoing in-service training, HHAs would have the opportunity to develop 
programs that would promote aide understanding of selective aspects of 
care and advance aide competency in general. 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. Because each HHA is unique and serves various populations, 
the proposed standard would allow a HHA to tailor its in-service 
training to the unique needs of the population it serves.
    We would retain the requirements in this proposed rule that aide 
in-service

[[Page 61180]]

training could be offered by any organization, and that the training 
would be required to be supervised by a RN. We propose to relocate the 
requirement that the RN 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, since this is 
the foundation of an aide's education in patient care. Supplemental 
education, such as in-service training, could be adequately handled by 
qualified RNs who may not possess as much experience. For some basic 
aide training, however, individuals other than a RN may be able to 
provide instruction. When other individuals provide instruction to home 
health aides, classroom and practical training would be required to be 
under the general supervision of a 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 propose to retain the current requirements at Sec.  
484.36(a)(2)(i) regarding organizations that offer aide training 
(generally, HHAs), with some revision and reorganization under a new 
standard at Sec.  484.80(f), ``Eligible training and competency 
evaluation organizations.'' We propose 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. When selecting 
an outside organization to provide aide training, we encourage HHAs to 
select organizations with demonstrated knowledge and experience related 
to the subject matter(s) being taught.
    We propose, at Sec.  484.80(g), Home health aide assignments and 
duties, to set forth aide responsibilities and duties, and are 
retaining most of current Sec.  484.36(c), Assignment and duties of the 
home health aide. However, we would make revisions to further support 
an interdisciplinary approach to care (as typified here and in Sec.  
484.60, Care planning, coordination of services, and quality of care).
    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). This proposed revision 
reflects an interdisciplinary team approach by adding the opportunity 
for additional skilled professionals to designate home health aide 
assignments. To the extent possible, we believe that there should be 
consistent assignment of aides to patients in order to facilitate 
continuity of care and communication. Currently, under Sec.  
484.36(c)(1), an appropriate skilled professional responsible for the 
supervision of the home health aide may provide only written patient 
care instructions for the home health aide. A RN is solely responsible 
for the assignments of home health aides to specific patients. However, 
we believe, for example, that if a patient is receiving physical 
therapy services, then the appropriate skilled professional (for 
example, a physical therapist) should be allowed to assign an aide to 
this patient. This is consistent with the current requirement at Sec.  
484.36(c) which require that the written patient care instructions for 
the home health aide be prepared by the appropriate professional 
responsible for the supervision of that home health aide. The ability 
to assess patients and take into account the many aspects of the 
patient's functioning would allow the RN or other skilled professional 
to identify patient needs, and match the skills of a particular home 
health aide to those needs.
    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. Home health 
aides could not furnish services outside of their scope of practice as 
defined by local and state laws, and the HHA's internal policies. In 
Sec.  484.80(g)(3), we propose 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 propose a requirement that home health 
aides be members of the interdisciplinary team, must report changes in 
the patient's condition to a RN or other appropriate skilled 
professional, and must complete appropriate records in compliance with 
the HHA's policies and procedures. As part of the interdisciplinary 
team, home health aides would be required to communicate to a RN or 
qualified therapist observations and experiences when caring for 
patients. Home health aides may observe changes in patient needs that 
are crucial to future treatment decisions, and these changes should be 
reported to the appropriate HHA professional in order to implement 
effective and appropriate changes in care. Under proposed Sec.  
484.80(g)(4), our intention is to reflect an interdisciplinary approach 
to care. In this case, the provision would emphasize the home health 
aide's role as a member of the interdisciplinary team. Because an aide 
may be the member of the home health team who is most often in the home 
with the patient, the aide may be the one most likely to note changes 
in a patient's condition. As observation skills are a required content 
area in aide training (see Sec.  484.80(b)(3)(ii)), we would expect 
that aides be taught to identify any changes that may need to be 
reported to the RN or other skilled professional.
    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 propose 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, 
and would be allowed to increase the number of home health aide-patient 
interaction observations as necessary to assure a full assessment of

[[Page 61181]]

the aide's patient care knowledge and skills.
    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 health aide while he or she is 
performing care.
    Irrespective of the 14-day and 60-day requirements, the agency 
would be responsible for maintaining appropriate supervision of a home 
health aide, and could utilize more frequent supervision at its 
discretion (for example, when a home health aide learns new skills). 
The HHA would also be expected to increase supervisory oversight for 
those home health aides for whom a request for supervision had been 
made either by the patient, representative, caregiver, or a family 
member.
    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. This 
proposed requirement would allow agencies to re-teach and reassess 
important home health aide skills to ensure that the home health aide 
provided safe and effective care to all patients at all times.
    We also propose 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.
    We would not set forth a specific requirement relative to the 
method of documenting the supervisory visit, but we expect that the HHA 
would develop a method of documentation that best fit its needs. 
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 propose 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. Placing this requirement 
within the HHA CoPs would afford protections to all individuals served 
in that setting, regardless of payer source. The requirements are 
designed to protect the patient, and are consistent with Sec.  
440.167(a), which states that patients receiving personal care services 
in their home are required to have a physician's authorization in 
accordance with a plan of treatment or a service plan approved by the 
state. Changes in the overall language of this provision would be made 
for the sake of clarity. 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 propose 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)
    Provisions concerning compliance with federal, state, and local 
laws are presently located at current Sec.  484.12, ``Condition of 
Participation: Compliance with Federal, State and local laws, 
disclosure and ownership information, and accepted professional 
standards and principles.'' We propose to retain most of the provisions 
contained in this condition with minor changes, which are discussed 
below. This proposed condition would now be set forth at Sec.  484.100.
    We propose to incorporate the standard at current Sec.  484.12(a) 
into the general opening statement of the condition at Sec.  484.100. 
At proposed Sec.  484.100(a), we would 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. Section 1126(b) of the 
Act, codified in regulations at Sec.  420.201 of our rules, specifies 
that the term ``managing employee'' means an individual, including a 
general manager, business manager, administrator, or director, who 
exercises operational or managerial control over the entity, or who 
directly or indirectly conducts the day-to-day operations of the 
entity. Accordingly, for purposes of this rule, ``director'' would 
refer to a corporate director and not a medical director or nursing 
director. Section 420.201 defines an ``agent'' as any person who has 
been delegated the authority to obligate or act on behalf of a 
provider. In this rule, we would intend an ``officer'' to be any person 
who is responsible for the overall management of the operation of the 
HHA; we also would require that the HHA provide information on all 
individuals who are officers of the HHA under the law of the state in 
which the HHA is incorporated. Because the business address of an 
agency is self-explanatory, the additional address we would request in 
the standard would refer to a residential address for all individuals 
to whom the rule applies. A Post Office Box address would not be 
considered a business or residential address and would not be 
satisfactory for purposes of compliance with this proposed requirement.
    We propose to remove the provisions regarding state licensure from 
current paragraph Sec.  484.12(a) and incorporate them into the 
proposed state licensure standard at Sec.  484.100(b). Under the 
provisions of proposed Sec.  484.100(b), a 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. In addition, the Act at Sec.  1861(o)(4) requires that a 
HHA, which would include a branch, must be licensed, or approved as 
meeting the standards established for licensing, in any state in which 
state or local law provides for the licensing or other approval of HHAs 
and their subsidiaries. If a state requires a HHA to have a license, 
then we would require that the provider be in compliance with that 
state's law or regulation. In addition, state licensure requirements 
are enforced at the state level and would

[[Page 61182]]

be subject to state jurisdiction. Therefore, the provisions of this 
proposed rule would not affect providers that have been granted waivers 
of state requirements.
    State surveyors are not, and have never been, responsible for 
citing HHAs for violating the rules of regulatory bodies other than the 
State or CMS. When a HHA is found to be out of compliance with a 
federal, state, or local law by another regulatory agency with 
jurisdiction and authority to cite noncompliance (for example, OSHA or 
the Department of Justice), CMS decides whether that violation should 
also constitute a violation of the HHA CoPs. Both the title of this 
proposed CoP and its introductory paragraph would refer to only those 
federal, state, and local laws and regulations which were ``related to 
the health and safety of patients.'' We would cite agencies when the 
violation of federal, state, or local laws or regulations could 
potentially affect the health and safety of the HHA's patients, and the 
rights and well-being of patients.
    Finally, we propose to move the current requirements at Sec.  
484.14(j), Laboratory services, to Sec.  484.100(c). Because this 
standard covers compliance with a federal regulation, we believe that 
it would be better suited under this proposed CoP governing compliance 
with federal, state, and local laws rather than under its current 
location at the end of the CoP covering organization, services, and 
administration of an HHA. Section 484.100(c) would 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 part 493 
(Laboratory Requirements).
    This section would also prohibit HHAs from substituting their own 
self-administered testing equipment, such as glucometers, in lieu of a 
patient's self-administered testing equipment when assisting a patient 
in administering the test. We propose this requirement to ensure that 
patients have access to their test results on their own equipment that 
is maintained in their home. This would allow patients to track their 
results over time and better understand the impact of their behaviors 
and choices upon their test results. Such understanding is an important 
step in fostering patient independence and positive patient outcomes. 
Agencies may use their own self-administered testing equipment as a 
complement to a patient's self-administered testing equipment when 
assisting a patient in administering the test when there is reason to 
believe that the patient's self-administered testing equipment is 
inaccurate. In this situation, we would expect the HHA to assist the 
patient in obtaining accurate testing equipment for future use. 
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.
    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). We are not proposing to alter the intent or meaning of this 
provision.
2. Organization and Administration of Services (Proposed Sec.  484.105)
    This proposed CoP on organization and administration of services 
would revise current regulations at Sec.  484.14, ``Organization, 
services, and administration.'' As previously discussed, the current 
regulation at Sec.  484.14(g), ``Coordination of patient services,'' 
would be relocated and revised under proposed Sec.  484.60. In 
addition, the current regulations found at Sec.  484.38, ``Qualifying 
to furnish outpatient physical therapy or speech pathology services,'' 
would be relocated to Sec.  484.105. The proposed new condition would 
simplify the structure of the current requirements, and focus on both 
essential organizational structures and performance expectations for 
the administration of HHA operations. With the diffusion of home health 
organization and management structures (currently, there are 2,660 
branches distributed among 1,301 parent HHAs nationwide), this proposed 
rule would help to ensure accountability by assisting agencies in 
setting performance expectations that we believe would lead to a higher 
level of quality for patients. The overall goal of the proposed 
condition is to produce a clear, accountable organization, management, 
and administration of a HHA's resources to attain and maintain the 
highest practicable functional capacity for each patient's medical, 
nursing, and rehabilitative needs, as indicated in the plan of care. 
Attaining and maintaining the highest practicable functional capacity 
for each patient is the primary goal of HHA services based on the 
premise that the role of the HHA is to assist each patient in 
overcoming any deficits that lead to his or her need for home health 
services. HHAs provide services, supplies, and education to patients, 
making every effort to encourage and support patient autonomy, self-
care, self-management, and ultimately discharge from the HHA.
    Under the current requirements found at Sec.  484.14(b), we would 
expect the governing body to be able to assess the HHA's financial 
needs and to assume responsibility for effectively managing its 
financial resources. We would maintain the intent of this requirement, 
at proposed Sec.  484.105(a), ``Governing body,'' and would expand the 
responsibilities of the governing body to 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, in addition to responsibility for the agency's 
fiscal operations, as retained from the current regulations.
    Proposed Sec.  484.105(b), ``Administrator,'' would describe the 
role of the administrator and provisions for when the administrator is 
not available. We propose 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. The 
current State Operations Manual (Pub 100-7, Appendix B, http://cms.hhs.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_b_hha.pdf) describes the concept of being available during 
operating hours as being on the premises of the HHA or by reachable via 
telecommunications. HHA management would have discretion to structure 
the implementation of this concept to suit the organization's needs. In 
addition, the current State Operations Manual also describes the 
concept of ``operating hours'' as all hours that staff from the agency 
is providing services to patients. Because HHAs are already familiar 
with these concepts, we are not proposing to change our 
interpretations.
    While we would expect the administrator to be available during all 
operating hours to take an active role in

[[Page 61183]]

the daily operations of the HHA, we recognize that there are times when 
the administrator cannot be available. We propose 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. The pre-designated person may be the same skilled professional 
described above. We note that, in addition to this requirement, we also 
propose personnel requirements for the administrator at Sec.  
484.115(a). The administrator, and the pre-designated person, would be 
required to meet these personnel requirements.
    In addition to the overall management of the HHA by the governing 
body and the administrator, we propose 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. Oversight of the services provided to 
patients would include, but would not be limited to, assigning 
clinicians to patients; coordinating care provided to patients by the 
various patient care disciplines; coordinating referrals within the 
HHA; assuring that patient needs are continually assessed; and assuring 
that patient plans of care are developed, implemented, and updated. We 
believe that the clinical manager role is essential for managing the 
complex, interdisciplinary care of home health patients, and that the 
responsibilities included in this new standard are not currently 
fulfilled. Six of the 20 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 is not being 
sufficiently planned, coordinated, and implemented to ensure the 
highest quality care for all HHA patients at all times. We believe that 
having a designated clinical manager will address this need while 
assuring that agency personnel standards are upheld.
    In Sec.  484.105(d), we propose a new standard, Parent-branch 
relationship. As discussed previously in the ``Definitions'' section of 
this preamble, we would change the definition of ``branch'' in Sec.  
484.2 to define a branch office as a location or site from which a HHA 
provides services within a portion of the total geographic area served 
by the parent agency. We would delete the portion of the definition 
referring to a branch location that is ``sufficiently close'' to the 
parent agency, because section 506(a)(1) of the Medicare, Medicaid and 
State Children's Health Insurance Program Benefits Improvement and 
Protection Act of 2000 (Pub. L. 106-554) (BIPA) mandated that neither 
time nor distance between a parent office of the HHA and a branch 
office shall be the sole determinant of a HHA's branch office status. 
However, both time and distance can still be considered as factors in 
conjunction with other considerations.
    We believe that the focus should be 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. The decision to approve a branch is based on 
the HHA's ability to assure that the quality and scope of items and 
services provided to all patients from the branch meets each patient's 
medical, nursing, and rehabilitative needs. Thus, we would expect that 
the lines of authority and professional and administrative control be 
clearly delineated in the HHA's organizational structure and in 
practice. The HHA parent should be aware of the staffing, patient 
census and any issues/matters affecting the operation of the branch. 
Furthermore, the administrator of the HHA must be able to maintain an 
ongoing liaison with the branch to ensure that staff is competent and 
able to provide appropriate, adequate, effective and efficient patient 
care so as to ensure that any clinical and/or other emergencies are 
immediately addressed and resolved. The HHA parent must be able to 
monitor branch activities (clinical and administrative) and the 
management of services, as well as personnel and administrative issues, 
including providing ongoing in-service training to ensure that all 
staff is competent to provide care and services. The HHA parent is 
responsible for any contracted arrangements with other individuals or 
organizations, even when the contracted services are used exclusively 
by the branch. We would also expect the HHA to be able to demonstrate 
its ability to ensure that patients being served by all offices 
consistently receive all necessary and appropriate care and services 
described in the plans of care. As part of the decision-making process, 
we will also consider an HHA's past compliance history and all relevant 
state issues and recommendations. These and other considerations in 
governing parent-branch relationships were previously included in a 
Survey and Certification memorandum (Requests for Home Health Agency 
Branch Office Approval and the Use of a Reciprocal Agreement, S&C-02-
30, issued May 10, 2002), and will inform future CMS subregulatory 
guidance on this topic.
    We provide guidance for approving a branch office in Sec.  2182.4B 
of the State Operations Manual. In addition, we assign identification 
numbers to every existing branch of a parent HHA and subunit. The 
identification system is implemented nationally, and uniquely 
identifies every branch of every HHA certified to participate in the 
Medicare home health program. It also links the parent to the branch. 
The branch identification number is also required on the OASIS 
assessments. This allows a HHA access to outcome reports that help it 
differentiate and monitor the quality of care delivered down to the 
branch level. (We note that although this information is available to 
HHAs, information is not broken down by branch when generating Home 
Health Compare results that are available to the general public.) 
Through this method of monitoring how services are furnished by its 
branches, the parent HHA can strengthen the parent-branch relationship 
and further ensure the quality of care delivered to its patients. We 
would also add to our regulations the requirement that HHAs report 
their branch locations to the state survey agency at the time of a 
HHA's initial certification request, at each survey, and at the time 
any proposed additions or deletions were made. This proposed rule would 
eliminate the ``subunit'' designation. An existing subunit currently 
operates under a distinct Medicare provider number and would be 
considered to be a distinct HHA upon implementation of this final rule, 
with its own governing body and administrator that is not shared with 
another HHA. Depending on state-specific laws and regulations, this 
regulatory change may allow a subunit to apply to become a branch 
office of a parent HHA if the parent could provide ``. . . direct 
support and administrative control of the branch.''
    In accordance with section 1861(m) of the Act, a HHA may provide 
its services directly and/or under arrangement with

[[Page 61184]]

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 debarred from participating in any government program. Therefore, 
the current requirement at Sec.  484.14(h) governing services under 
arrangement would be retained with a minor revision in the proposed 
standard at Sec.  484.105(e), Services under arrangement. We propose 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 would 
correct a typographical error in the cross-reference citation for the 
United States Code.
    We propose to move the current standard at Sec.  484.14(a), 
``Services furnished,'' to Sec.  484.105(f)(1). According to section 
1861(o) of the Act, for purposes of participation in the Medicare 
program, a HHA is defined as being ``primarily engaged in providing 
skilled nursing services and other therapeutic services,'' without 
reference to the services being provided on a part-time or intermittent 
basis as provided in the current regulation. Although certain payment-
related requirements make reference to the intermittent nature of HHA 
services, the phrase ``part-time or intermittent'' is not used in the 
statutory definition of an HHA. In order to more closely align with the 
statutory definition, we propose to delete it from this standard. 
However, the use of the term ``part-time or intermittent'' would 
continue to exist under the coverage and eligibility requirements for 
home health services.
    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. This is a current requirement and would 
be retained. Other services could be offered under arrangement with 
another agency or organization. It should be noted that while HHAs may 
provide other services such as continuous nursing care either directly 
or under arrangement, those additional services might not be eligible 
for coverage under the Medicare program.
    Additionally, we propose to retain the requirements of current 
Sec.  484.12(c), ``Compliance with accepted professional standards and 
principles,'' at Sec.  484.105(f)(2). We would continue to require that 
HHAs furnish all services in accordance with accepted professional 
standards of practice. We would also propose to require that all HHA 
services be provided in accordance with current clinical practice 
guidelines. We believe that this addition is necessary to ensure that 
HHA patients receive care that is based on clinical evidence, where 
available, and up-to-date medical practices.
    Within this proposed CoP, we are moving current Sec.  484.38, 
``Qualifying to furnish outpatient physical therapy or speech pathology 
services,'' to Sec.  484.105(g). We believe that this requirement would 
be more appropriately codified as a standard (now titled ``Outpatient 
physical therapy or speech-language pathology services'') following the 
``Services furnished'' standard under this proposed CoP. We propose to 
make no other changes to this standard.
    Finally, we propose to retain the ``Institutional planning'' 
standard currently located at Sec.  484.14(i) and as required for HHAs 
under Sec.  1861(z) of the Act. We would retain this standard at Sec.  
484.105(h) without any revisions.
3. Clinical Records (Proposed Sec.  484.110)
    In this section of the preamble we describe: (A) Changes to the 
conditions of participation related to clinical record requirements; 
and (B) the HHS policy priority to accelerate interoperable health 
information exchange including through the use of certified electronic 
health record technology.
    (A) Changes to the conditions of participation related to clinical 
record requirements. This proposed section would retain, with some 
additional clarification, many of the long-standing clinical record 
requirements currently found at Sec.  484.48. In this condition, we 
propose to retain only those process requirements which provide 
essential patient health and safety protection.
    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 propose 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 information could be maintained electronically. 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. Consistency would be reflected in the appropriate link between 
patient assessment information and the services and treatments ordered 
and furnished in the plan of care. In light of the decentralized nature 
of HHAs (that is, patient care is not furnished in a single location), 
we believe that members of the interdisciplinary team must have access 
to patient information in order to provide quality services. Many HHAs 
maintain electronic records, and we recognize that this technological 
change in home health care industry can provide all members of the 
interdisciplinary team access to important patient care information on 
an ongoing basis.
    Proposed Sec.  484.110(a), ``Contents of clinical record,'' 
contains several elements that are part of the current clinical record 
requirement. We propose to retain the requirement that the record 
include clinical notes, plans of care, physician orders, and a 
discharge summary. To give HHAs flexibility in maintaining clinical 
records, we propose to no longer specifically require that the name of 
physician and drug, dietary, treatment, and activity orders be included 
in a dedicated part of the clinical record, since these items would 
already have been made part of the plan of care, and thus would already 
be included in the clinical record. We also propose to add requirements 
to this standard that reflect our outcome-oriented approach to patient 
care. Specifically, at proposed Sec.  484.110(a), we would 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,

[[Page 61185]]

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 believe that these timeframes are necessary to assure that 
providers assuming responsibility for the care of discharged patients 
have timely information about the patient's recent care, services, and 
medications. We request public comment regarding these timeframes. 
Specifically, we would like to know if these timeframes are adequate to 
assure a smooth transition of care. We would also like to know whether 
current HHA record systems are capable of producing a discharge summary 
in a shorter period of time, such as the same day that a patient is 
discharged.
    We believe that these requirements are the minimum necessary for a 
meaningful clinical record, and that they would still provide the HHA 
with flexibility in maintaining the clinical record while ensuring that 
the record contains information necessary for providing high quality 
patient care. HHAs may choose to maintain additional information in the 
record which reflects activity pertinent to the patient and his or her 
care.
    We propose to add a new standard at Sec.  484.110(b) to require 
authentication of clinical records. We would require that all entries 
be legible, clear, complete, and appropriately authenticated, dated, 
and timed. Appropriate authentication refers to the process of 
identifying the person who has made an entry into the clinical record 
and that person's acknowledgement, by a signature and a title, or use 
of an electronic identifier, that he/she is responsible for the 
content, accuracy, and completeness of the entry. Authentication for 
every entry would be required to include a signature and a title, or a 
secured computer entry by a unique identifier, of a primary author who 
had reviewed and approved the entry. This provision would allow HHAs to 
establish clear policies about clinical record entries and corrections. 
It is preferred that the original clinician make any necessary 
corrections to his or her entries to ensure continuity and consistency 
within the clinical record. In cases where the original clinician is 
unable to correct his or her entry, we would expect to see 
documentation of communication with the original clinician regarding 
modifications to the original entry. We believe it is important to 
retain flexibility to accommodate the variation in types of 
documentation and decision making used throughout the industry, and the 
need to allow HHAs to innovate and improve documentation, including 
using electronic record formats, without unnecessary restrictions.
    Under proposed Sec.  484.110(c), we would revise the current 
requirements under Sec.  484.48(a), ``Retention of records.'' With 
proposed Sec.  484.110(c)(1), we would revise the provision regarding 
the timing of the 5-year clinical record retention period. We do not 
believe that the current provision, which predicates the beginning of 
the 5-year retention period on when the cost report is filed with the 
intermediary, ensures patient safety. Therefore, we have simplified the 
provision to now require that clinical records be retained for 5 years 
after the discharge of the patient, unless state law stipulates a 
longer period of time. In addition to these proposed clinical record 
retention requirements, HHAs would be expected to continue to comply 
with other Medicare or Medicaid record requirements for payment 
purposes.
    We would continue to require, in Sec.  484.110(c)(2), that HHA 
policies provide for retention of records even if the HHA discontinues 
operations. However, we also propose that the HHA would be required to 
notify the state agency as to where the agency's clinical records would 
be maintained. We also propose at Sec.  484.110(d) to incorporate into 
this condition the requirement under current Sec.  484.48(b), 
``Protection of records,'' relative to the safeguarding of information. 
At proposed Sec.  484.110(d), we would require that clinical records, 
their contents, and the information contained therein, be safeguarded 
against loss or unauthorized use. We believe that the requirement under 
current Sec.  484.48(b), concerning the release of clinical record 
information, is best incorporated into the proposed standard at Sec.  
484.50(e), Right to confidentiality of clinical records, as noted 
earlier in this preamble.
    Finally, under this clinical records condition, we would add a new 
standard at Sec.  484.110(e), Retrieval of clinical records. We propose 
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 
to those outside of the HHA would be required to be in compliance with 
the rules regarding personal health information set out at 45 CFR parts 
160 and 164.
    We note that 45 CFR 164.512 provides for certain ``disclosures 
required by law'' without the permission of the patient. We believe 
that this standard is necessary for two main reasons. First, we believe 
that the prompt retrieval of patient records is essential to assuring 
communication, continuity and quality of care within the HHA, as well 
as between the HHA and other health care entities furnishing care to 
the patient. Second, in order to enable state surveyors to effectively 
assess HHA compliance with these regulations, and to enable the quality 
improvement organizations to fulfill their role in the beneficiary 
complaint process, timely retrieval of clinical records is essential.
    (B) HHS Policy Priority to Accelerate Interoperable Health 
Information Exchange, including Use of Certified Electronic Health 
Record Technology.
    HHS believes all patients, their families, and their healthcare 
providers should have consistent and timely access to their health 
information in a standardized format that can be securely exchanged 
between the patient, providers, and others involved in the patient's 
care. (cite: HHS August 2013 Statement, ``Principles and Strategies for 
Accelerating Health Information Exchange.'') The Department is 
committed to accelerating health information exchange (HIE) through the 
use of electronic health records (EHRs) and other types of health 
information technology (HIT) across the broader care continuum through 
a number of initiatives including: (1) Alignment of incentives and 
payment adjustments to encourage provider adoption and optimization of 
HIT and HIE services through Medicare and Medicaid payment policies, 
(2) adoption of common standards and certification requirements for 
interoperable HIT, (3) support for privacy and security of patient 
information across all HIE-focused initiatives, and (4) governance of 
health information networks. These initiatives are designed to improve 
care delivery and coordination across the entire care continuum and 
encourage HIE among all health care providers,

[[Page 61186]]

including professionals and hospitals eligible for the Medicare and 
Medicaid EHR Incentive Programs and those who are not eligible for the 
EHR Incentive Programs. To increase flexibility in the regulatory 
certification structure established by the Office of the National 
Coordinator for Health Information Technology (ONC) and expand HIT 
certification, ONC has proposed a voluntary 2015 Edition EHR 
Certification rule (http://www.gpo.gov/fdsys/pkg/FR-2014-02-26/pdf/2014-03959.pdf) to more easily accommodate HIT certification for 
technology used by other types of health care settings where individual 
or institutional health care providers are not typically eligible for 
incentive payments under the EHR Incentive Programs, such as home 
health agencies, and other long-term and post-acute care and behavioral 
health settings.
    We believe that HIE and the use of certified EHRs by home health 
agencies (and other providers ineligible for the Medicare and Medicaid 
EHR Incentive programs) can effectively and efficiently help providers 
improve internal care delivery practices, support management of patient 
care across the continuum, and enable the reporting of electronically 
specified clinical quality measures (eCQMs). More information on the 
identification of EHR certification criteria and development of 
standards applicable to home health agencies can be found at the 
following locations:
     http://healthit.gov/policy-researchers-implementers/standards-and-certification-regulations
     http://www.healthit.gov/facas/FACAS/health-it-policy-committee/hitpc-workgroups/certificationadoption
     http://wiki.siframework.org/LCC+LTPAC+Care+Transition+SWG
     http://wiki.siframework.org/Longitudinal+Coordination+of+Care
    In 2012, ONC sought public comment on whether it should focus any 
certification efforts towards the health IT used by health care 
providers that are ineligible to receive incentives under the EHR 
Incentive Programs. In the regulations establishing the 2014 Edition of 
health IT standards and EHR certification criteria (http://www.gpo.gov/fdsys/pkg/FR-2012-09-04/pdf/2012-20982.pdf), ONC concluded, ``. . . 
that it makes good policy sense to support interoperability and the 
secure electronic exchange of health information between all health 
care settings. We believe the adoption of EHR technology certified to a 
minimal amount of certification criteria adopted by the Secretary can 
support this goal. To this end, we encourage EHR technology developers 
to certify EHR Modules to the transitions of care certification 
criteria (Sec.  170.314(b)(1) and Sec.  170.314(b)(2)) as well as any 
other certification criteria that may make it more effective and 
efficient for EPs, EHs, and CAHs to electronically exchange health 
information with health care providers in other health care settings. 
The adoption of EHR technology certified to these certification 
criteria can facilitate the secure electronic exchange of health 
information.'' ONC has also published, ``Certification Guidance for EHR 
Technology Developers Serving Health Care Providers Ineligible for 
Medicare and Medicaid EHR Incentive Payments'' (http://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_9-9-13.pdf).
    In 2013, the Department of HHS requested information on how to 
accelerate interoperable health information exchange including with 
long-term and post-acute care providers. The public offered several 
recommendations for the use of EHR certification and the expansion of 
the ONC HIT Certification Program (See http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf. See page 5 for a 
summary of these recommendations). Among the suggested recommendations 
from the public was to make certified EHR technology available to long-
term and post-acute providers (and other providers not eligible for the 
Medicare and Medicaid EHR Incentive Programs).
    In the fall of 2013, ONC requested that the HIT Policy Committee (a 
Federal advisory committee established under the HITECH legislation and 
responsible for advising the National Coordinator for Health 
Information Technology on the development, harmonization, and 
recognition of standards, implementation specifications, and EHR 
certification criteria) to begin exploring the expansion of 
certification under the ONC HIT Certification Program, particularly 
focusing on EHR certification for the long-term and post-acute care and 
behavioral health care settings. The Certification/Adoption Workgroup 
of the HIT Policy Committee is expected to present its recommendations 
to the HIT Policy Committee in the spring of 2014. The full Health IT 
Policy Committee will make recommendations to the ONC in summer 2014.
    As noted, the ONC publishes rules for health IT standards and EHR 
certification criteria. A key standard adopted in the 2014 Edition 
Final Rule was the HL7 Consolidated CDA (CCDA) standard. The CCDA is 
now the single standard permitted for certification and the 
representation of summary care records. This standard is used for the 
exchange of Summary Care Records at times of transition in care (for 
example, discharge) and making available clinical information to 
patients.
    Activities have been undertaken to update the CCDA. The Standards 
and Interoperability Framework, Longitudinal Coordination of Care (S&I 
LCC WG) has worked to address gaps in the CCDA to better support the 
interoperable exchange of documents and content needed at times of 
transitions in care and referrals in care, and for the exchange of care 
plans, including the home health plan of care. The S&I LCC WG is a 
public/private collaboration. Members of this workgroup included 
representatives of the National Association of Home Care, Home Care 
Technology Association of America, the Visiting Nurse Service of New 
York, and many other clinicians, researchers, vendors, and government 
representatives. The updates to the CCDA were balloted by HL7 in the 
fall 2013, and comments have been reconciled. HL7 is expected to 
publish the CCDAr2 in spring 2014.
    On February 26, 2014 ONC published the proposed rule for the 2015 
Edition of Health IT standards and EHR certification criteria. The ONC 
2015 Edition proposed rule proposes an updated version for the CCDA, 
the CCDA[supreg] Release 2 (CCDAr2). The CCDAr2 includes enhancements 
to more completely support interoperability for documents needed at 
times of transitions and referral in care and care plans, including the 
home health plan of care. The CCDAr2 includes new sections for: Goals; 
Health Concerns; Health Status Evaluation/Outcomes; Mental Status; 
Nutrition; Physical Findings of Skin; and many other entries.
    We encourage home health providers to use, and their health IT 
vendors to develop, ONC-certified HIT/EHR technology to support 
interoperable health information exchange with physicians, hospitals, 
other LTPAC providers, and with their patients. We anticipate that the 
use of certified HIT/EHR technology will help improve quality and 
coordination of care, and reduce costs.
4. Personnel Qualifications (Proposed Sec.  484.115)
    Currently, provisions concerning the qualifications of HHA 
personnel are located at Sec.  484.4. This section provides very 
specific credentialing requirements that all staff are required to 
meet. While we are retaining most of these current personnel 
qualification requirements,

[[Page 61187]]

we propose revisions to the organization of the ``Personnel 
qualifications'' CoP. Many other provider types cross-reference the HHA 
personnel requirements, and we are proposing conforming amendments 
accordingly.
    Under our proposed reorganization of part 484, personnel 
qualifications would be located at Sec.  484.115. Personnel 
qualifications would be set out as general qualification requirements 
(which would cover all personnel), and personnel qualifications when 
state licensing laws or state certification or registration 
requirements exist (which would cover the additional requirements to 
practice under and in accordance with state laws, and which would cover 
all personnel where applicable). The proposed personnel qualifications 
CoP is discussed in detail below.
    This proposed standard would consist of all personnel 
qualifications found under current Sec.  484.4, with the exception of 
those for public health nurses. Except as noted below, we propose to 
retain the current personnel qualifications for the following 
professions: Administrator, 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 propose to delete the current qualification category for public 
health nurses because public health nurses are RNs, and the 
qualifications for RN are already included in this section. We also 
propose to replace the term ``practical (vocational) nurse,'' currently 
found in Sec.  484.4, with the more widely used and accepted term, 
``licensed practical nurse.'' The proposed qualifications for a 
licensed practical nurse would be a person who has completed a 
practical nursing program, and who furnishes services under the 
supervision of a qualified registered nurse. Currently, the 
requirements for the supervision of licensed practical nurses, 
occupational therapy assistants and physical therapist assistants, and 
social work assistants are found under Sec.  484.30, Sec.  484.32, and 
Sec.  484.34, respectively. We propose to retain these supervision 
requirements and relocate them under the applicable profession's 
qualifications and as described in this proposed standard.
    We also propose to revise the current personnel qualifications for 
HHA administrators. Our intent with this provision is to give HHAs 
flexibility. Therefore, with this provision we would expand the 
qualifications by which an individual could meet the requirement for an 
administrator. Specifically, proposed Sec.  484.115(a) would set forth 
the requirements that a HHA administrator would be required to be a 
licensed physician, or hold an undergraduate degree, or be a registered 
nurse. We also propose that an administrator would have at least 1 year 
of supervisory or administrative experience in home health care or a 
related health care program. The possession of an undergraduate degree 
would be a new option for establishing the qualifications of an 
administrator that does not exist in the current regulations. We 
believe that this new option will give HHAs additional flexibility in 
selecting an appropriate administrator. However, we do not believe it 
is necessary to specify which undergraduate degree would be necessary 
to qualify for this option. Rather, we propose that the HHA's governing 
body would specify which undergraduate degree an HHA administrator 
would have to possess. In the absence of state requirements, we are not 
proposing to add financial management training as a requirement for HHA 
administrators at this time since HHAs often employ or consult a chief 
financial officer and billing staff, and the provision may place an 
additional burden on current HHAs. We specifically ask for comments on 
this proposal.
    At Sec.  484.105(a), the governing body would be responsible for 
appointing a qualified administrator, subject to the proposed 
requirements at Sec.  484.115(a). If the governing body believed 
additional qualifications were required for an administrator, it could 
include these in its hiring criteria.
    At Sec.  484.115(k) and (l), we propose to retain the current 
requirements for both social work assistants and social workers, 
respectively. Currently, a qualified social worker is an individual who 
has a master's degree in social work (MSW) from an accredited school of 
social work and who has 1 year of social work experience in a health 
care setting. A qualified social work assistant is currently a person 
who has a baccalaureate degree in social work, psychology, sociology, 
or other field related to social work, and who has at least 1 year of 
social work experience in a health care setting. A social work 
assistant is also considered to be qualified under the current home 
health CoPs if he or she 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. However, 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. We believe that these current personnel requirements adequately 
meet the needs of HHA patients. We propose to clarify the requirement 
for a social worker by amending the regulation to state that those who 
hold a doctoral degree in social work would also meet the qualification 
requirements.
    Finally, we propose 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) of the 
Act. We propose 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 such services. To the extent of our knowledge, all states 
license SLPs; therefore all SLPs would be covered by this option. We 
believe that deferring to the states to establish specific SLP 
requirements would allow all appropriate SLPs to provide services to 
beneficiaries. Should a state choose to not offer licensure at some 
point in the future, we propose a second, more specific, option for 
qualification. In that circumstance, we would require that 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 nine 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. These specific requirements are 
set forth in the Act, and we believe that they are appropriate for 
inclusion in the regulations as well.

IV. Home Health Crosswalk (Cross Reference of Current to Proposed 
Requirements)

    The table below shows the relationship between the current sections 
to the proposed.

[[Page 61188]]



------------------------------------------------------------------------
              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.
484.10(a)..............................  Revised at Sec.   484.50(a).
484.10(b)..............................  Revised at Sec.  Sec.
                                          484.50(b), (c), and (e).
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 outcome
                                          and assessment information set
                                          (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.   484.75(d),
                                          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).
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).
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.
------------------------------------------------------------------------


[[Page 61189]]

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection 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 are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs).
Assumptions and Estimates
    We have made several assumptions and estimates in order to assess 
both the time that it would take for a 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...........       11,930
Number of Medicare participating HHAs that are accredited..        5,000
Number of HHA patients in Medicare participating HHAs         17,751,840
 nationwide................................................
Number of HHA patients in Medicare participating,              7,440,000
 accredited HHAs...........................................
Number of Medicare beneficiaries in HHAs...................    3,489,201
Average number of new HHAs per year........................          549
Average number of new, non-accredited HHAs per year........           65
Average number of patients per HHA per year................        1,488
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) *........         $144
Hourly rate of clinician (average of Nurse, Aide,                    $76
 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.

Collection of Information Requirements--Discussion and Summary

A. ICRs Regarding Condition of Participation: Reporting OASIS 
Information (Sec.  484.45)
    Proposed Sec.  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. While 
this requirement is subject to the PRA, the burden is currently 
approved under the following OMB control number, 0938-0760.
B. ICRs Regarding Condition of Participation: Patient Rights (Sec.  
484.50)
    Proposed Sec.  484.50 would implement 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 would 
be required to inform each patient of their rights. In proposed Sec.  
484.50, we would 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 proposed rule include:
     A HHA must provide the patient and representative with an 
oral and a written notice of the patient's rights in advance of 
furnishing care to the patient in a manner that the individual can 
understand. The HHA must also document that it has complied with the 
requirements of this section.
     A 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.
     A 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.
     A HHA must advise the patient of the HHA's policies and 
procedures regarding the disclosure of patient records.
     A HHA must advise the patient of his or her liability for 
payment.
     A 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 propose that HHAs

[[Page 61190]]

must also advise the patient of the following:
     The names, addresses, and telephone numbers of pertinent 
State and local consumer information, consumer protection, and advocacy 
agencies.
     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). 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 proposed in this rule; therefore this rule would 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 520 hours (8 hours per 
HHA x 65 HHAs). The estimated cost associated with this requirement is 
$784 per HHA and $50,960 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 11,930 
hours and a cost of $1,169,140.
    The burden associated with Sec.  484.50(e) would be the time and 
effort necessary to document a patient complaint and its resolution. We 
estimate that, in a 1 year period, a HHA would need to document 
complaints involving about 5 percent (74) of its patients. We estimate 
that the documentation would require 5 minutes per investigation. 
Accredited HHAs are already required by their accrediting bodies to 
adhere to stringent patient rights violation investigation and record-
keeping standards; therefore accredited HHAs would not be burdened by 
this new standard. The total annual burden per non-accredited HHA 
(6,930) would be 6 hours (74 investigations x 5 minutes per 
investigation/60).
    We believe that the requirements of proposed standard (f), 
``Accessibility,'' related to providing information to patients in a 
manner that can be understood would not impose a burden because HHAs 
are already required to comply with these requirements in accordance 
with Title VI of the Civil Rights Act of 1964, the Americans With 
Disabilities Act, and Section 504 of the Rehabilitation Act. HHAs 
should already be in compliance with these longstanding requirements.
C. ICRs Regarding Condition of Participation: Comprehensive Assessment 
of Patients (Sec.  484.55)
    Proposed Sec.  484.55 would require 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. While these requirements are subject to 
the PRA, the associated burden imposed by these requirements is 
considered to be usual and customary medical practice as defined in 5 
CFR 1320.3(b)(2). All health care providers, regardless of their type 
of service, location, or other factors, routinely assess patients to 
determine their current status and care needs in keeping with the basic 
tenets of medical care as well as discipline-specific licensure 
requirements.
D. ICRs Regarding Condition of Participation: Care Planning, 
Coordination of Services, and Quality of Care (Sec.  484.60)
    The proposed requirements in this section would reflect an 
interdisciplinary, coordinated approach to home health care delivery. 
Proposed Sec.  484.60 would require 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 would 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 new section 
incorporates several of the current requirements under 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.
    Proposed Sec.  484.60(a) would require that each patient's written 
plan of care be established and periodically reviewed by a doctor of 
medicine, osteopathy, or podiatry. While HHAs average 1,488 home health 
patient admissions per year, 292 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 would do this in the absence of this 
proposed requirement. Thus this requirement would not impose a burden 
for those 292 Medicare patients per HHA. The anticipated burden 
associated with this requirement involves a member of the office 
support staff who would facilitate interaction with the physician. We 
estimate that this would take 5 minutes per admission for a total 
estimated burden of 100 hours per HHA ([1196 non-Medicare admits per 
year x 5 minutes]/60 minutes per hour).
    Proposed Sec.  484.60(a)(4) and (b)(1) would require 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. While this requirement is subject to the PRA, we believe 
that this is usual and customary medical practice and therefore does 
not add additional burden as specified in 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.
    Proposed Sec.  484.60(c) would require 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. This requirement is 
currently approved under OMB control number 0938-0365. Proposed Sec.  
484.60(e) would require a HHA to develop a discharge summary for each 
patient upon his or her discharge. The standard would describe the 
necessary elements of the discharge summary, but would not require a 
specific form to be used. The current HHA requirements at Sec.  484.48, 
Clinical records, already requires HHAs to develop and file a discharge 
summary for each discharged patient. Therefore, we believe that 
developing a discharge summary is a usual and customary HHA practice 
and does not add additional burden.

[[Page 61191]]

E. ICRs Regarding Condition of Participation: Quality Assessment and 
Performance Improvement (QAPI) (Sec.  484.65)
    Proposed Sec.  484.65 would require HHAs to develop, implement, 
maintain and evaluate an effective, data driven quality assessment and 
performance improvement program. Current requirements for HHAs do not 
provide for the operation of an internal quality assessment and 
performance improvement program, whereby the HHA examines its methods 
and practices of providing care, identifies the opportunities to 
improve its performance and then takes actions that result in higher 
quality of care for HHA patients. 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 would replace the current 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 a 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 
participate in periodic, external quality improvement reporting 
requirements as may be specified by CMS.
    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 27,720 hours. (4 hours per HHA x 6,930 non-accredited HHAs), 
and an industry-wide cost of $1,746,360 (27,720 hours x $63/hour).
    Although there are other QAPI requirements, they do not relate to 
record keeping and, therefore, are not relevant to this section.
F. ICRs Regarding Condition of Participation: Infection Prevention and 
Control (Sec.  484.70)
    Proposed Sec.  484.70 would require and HHA to maintain and 
document an infection control program with the goal of preventing and 
controlling infections and communicable diseases. Specifically, 
proposed Sec.  484.70(b) would state 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. Proposed 
Sec.  484.70(c) would also require that each HHA provide infection 
control education to staff, patients, and caregivers. We believe the 
associated burden for documenting the infection prevention and control 
program is exempt as stated in 5 CFR 1320.3(b)(2). 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, maintaining documents and 
disclosing information pertaining to infection control is generally 
regarded as a usual and customary business practice in the HHA 
community.
G. ICRs Regarding Condition of Participation: Skilled Professional 
Services (Sec.  484.75)
    We propose to consolidate current 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. Rather than having separate CoPs for each discipline, we would, 
in a single CoP, broadly describe the expectations for all skilled 
professionals who participate in the interdisciplinary approach to home 
health care delivery. Proposed Sec.  484.75 would require 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. Proposed 
Sec.  484.75 would also require skilled professionals to be actively 
involved in the HHA's QAPI program and participate in HHA in-service 
trainings. Furthermore, proposed Sec.  484.75 would require skilled 
professional services to be supervised. Clinician involvement in 
patient care, quality improvement efforts, and continuing education are 
all commonly accepted as good medical practice and 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. In addition, the aforementioned 
requirements would in all likelihood exist in the absence of federal 
regulations, thereby exempting the associated burden as stated in 5 CFR 
1320.3(b)(3).
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.
    In this rule we propose to retain, for the most part, the 
requirements at current Sec.  484.36, but place them in a new condition 
of participation at Sec.  484.80. We would also add the provisions from 
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. A HHA is 
required to maintain documentation that each home health aide meets 
these

[[Page 61192]]

qualifications as specified in proposed 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 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 1,988 annual burden hours ([5 minutes per aide x 2 aides per 
HHA]/60 minutes per hour x 11,930 HHAs) for the home health industry. 
We assume 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 $51,688 (1,988 hours x $26/hour).
    Proposed Sec.  484.80(b)(1) through (3) would discuss the content 
and duration of the home health aide classroom and supervised practical 
training. With respect to the recordkeeping requirements, proposed 
Sec.  484.80(b)(4) states that an HHA would be 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 11,930 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 1,988 hours ([5 minutes per aide x 2 aides 
per HHA]/60 minutes per hour x 11,930 HHAs). The cost burden associated 
with this requirement is $51,688, based on an office employee 
completing the documentation ($26/hour x 1,988 hours).
    Proposed Sec.  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, proposed Sec.  484.80(c)(5) 
states that an HHA would be 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 
11,930 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 1,988 hours ([5 minutes per aide x 2 aides per HHA]/60 
minutes per hour x 11,930 HHAs). The cost burden associated with this 
requirement is $51,688, based on an office worker completing the 
documentation ($26/hour x 1,988 hours).
    Proposed Sec.  484.80(d) states that a home health agency would be 
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 2 hours per HHA, 
annually, to meet this requirement ([5 minutes per aide per training x 
4 trainings per year x 6 aides]/60 minutes per hour). The estimate 
total annual burden for this requirement is 23,860 hours (2 hours per 
HHA x 11,930 HHAs).
    Proposed Sec.  484.80(g) would state 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 medical practice, and is 
therefore exempt from the PRA under 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 proposed rule at Sec.  484.80(h) would also require 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 is standard practice and thereby 
exempt from the PRA under 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)
    Provisions concerning compliance with federal state, and local laws 
are currently located at Sec.  484.12, ``Compliance with Federal, State 
and local laws, disclosure of ownership information and accepted 
professional standards and principles.'' We propose to retain most of 
the provisions contained in this condition with minor changes, which 
are discussed below. Under the proposed reorganization scheme, 
discussed above, this condition would be set forth at Sec.  484.100.
    As stated in proposed Sec.  484.100(a), the HHA would be 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 current 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 per HHA, for a 
total of 994 hours for the HHA industry as a whole on a one-time basis 
([5 minutes per modification x 11,930 existing agencies]/60 minutes per 
hour). Additionally, we estimate that it would require new HHAs 1 hour 
to develop a disclosure statement, for a total of 549 annual hours 
industry wide each year (1 hour per new HHA x 549 new HHAs).
J. ICRs Regarding Condition of Participation: Organization and 
Administration of Services (Sec.  484.105)
    This proposed section would set forth the organization and 
administration of services provided by a HHA. It would

[[Page 61193]]

state 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. The revised organization and 
administration of services condition would simplify the structure of 
the current requirements, and provide flexibility to the HHA by 
reducing the current focus on organizational structures and focusing on 
new performance expectations for the administration of the HHA as an 
organizational entity. Although there are reporting and documentation 
requirements associated with the proposed requirements, these 
activities are standard business practice and would not impose a burden 
on HHAs. For example, proposed Sec.  484.105(d)(1) would state 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, proposed Sec.  484.105(e)(2) would 
state 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 actions is 
exempt from the PRA under 5 CFR 1320.3(b)(2).
    Paragraph (h) of this section, Institutional planning, would impose 
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 proposed 
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 3,465 hours ([6,930 
existing non-accredited HHAs x 30 minutes]/60 minutes per hour). The 
estimated annual burden for anticipated new HHAs is 98 hours (1.5 hours 
per HHA x 65 new HHAs).
K. ICRs Regarding Condition of Participation: Clinical Records (Sec.  
484.110)
    This section would set 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 would be authenticated, dated and timed, 
which is usual and customary clinical practice and does not impose a 
burden. Clinical records would be retained for 5 years after the month 
the cost report for the records is filed with the intermediary. HHAs 
would be 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. While these requirements are 
subject to the PRA, we believe the associated burden is exempt as 
stated in 5 CFR 1320.3(b)(2). The aforementioned documentation and 
record retention requirements are considered usual and customary 
business practices and impose no additional burden.
    At Sec.  484.110(a)(5) we propose to require a HHA to send a copy 
of a patient's discharge 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 a HHA would spend 5 
minutes per patient sending the discharge summary to the patient's next 
source of health care services, for a total of 124 hours per average 
HHA annually ([5 minutes per patient x 1,488 patients]/60 minutes per 
hour) at a cost of $3,224 for an office employee to send the required 
documentation ($26 per hour x 124 hours). Complying with this provision 
would require 1,479,320 hours (124 hours per HHA x 11,930 HHAs) and 
$38,462,320 ($3,224 per HHA x 11,930 HHAs) for all HHAs, annually.
    Furthermore, a home health agency must make clinical records, 
whether in hard copy or electronic form, readily available on request 
by an appropriately authorized individual or entity. The burden 
associated with this requirement is the time and effort required to 
disclose a clinical record to an appropriate authority. While this 
requirement is subject to the PRA, we believe the associated burden is 
exempt as stated in 5 CFR 1320.3(b)(2). Making clinical records 
available to the appropriate authority is part of the survey and 
certification process, and imposes no additional burden as a usual and 
customary business practice.
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 5 CFR 1320.3(b)(2), these requirements are usual and customary 
business practices. As defined in 5 CFR 1320.3(b)(3), a state 
requirement would exist even in the absence of the federal requirement. 
The associated burden is thereby exempt.

                                 Table 2--Burden and Cost Estimates Associated With Information Collection Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Hourly
                                                                                 Burden per   Total annual    labor cost
      Regulation  section        OMB Control No.   Respondents     Responses      response     burden (in         of       Total cost of    Total costs
                                                                                 (in hours)      hours)       reporting    reporting ($)        ($)
                                                                                                                 ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   484.50(a) *............  0938--New........           65              65            8           * 520           98          50,960          50,960
Sec.   484.50(a) *............  0938--New........       11,930          11,930            1        * 11,930           98       1,169,140       1,169,140
Sec.   484.50(e)..............  0938--New........        6,930         512,820        0.083          42,735           63       2,692,305       2,692,305
Sec.   484.60(a)..............  .................       11,930      14,268,280        0.083       1,189,023           26      36,914,598      36,914,598
Sec.   484.65(e) *............  0938--New........        6,930           6,930            4        * 27,720           63       1,746,360       1,746,360
Sec.   484.80(a)..............  0938--New........       11,930          23,860        0.083           1,988           26          51,688          51,688
Sec.   484.80(b)..............  0938--New........       11,930          23,860        0.083           1,988           26          51,688          51,688
Sec.   484.80(c)..............  0938--New........       11,930          23,860        0.083           1,988           26          51,688          51,688
Sec.   484.80(d)..............  0938--New........       11,930         286,320        0.083          23,860           26         620,360         620,360
Sec.   484.100(a).............  0938--New........       11,930          11,930        0.083             994           98          97,412          97,412

[[Page 61194]]

 
Sec.   484.100(a) *...........  0938--New........          549             549            1           * 549           98          53,802          53,802
Sec.   484.105(h).............  .................        6,930           6,930          0.5           3,465           98         339,570         339,570
Sec.   484.105(h).............  .................           65              65          1.5              98           98           9,604           9,604
Sec.   484.110(a).............  0938--New........       11,930      17,751,840        0.083       1,479,320           26      38,462,320      38,462,320
                                                  ------------------------------------------------------------------------------------------------------
    Total.....................  .................       19,474      32,929,239  ...........       2,786,178  ...........      82,311,495      82,311,495
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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.
    If you comment on these information collection and recordkeeping 
requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this proposed rule; or
    2. Submit your comments to the Office of Information and Regulatory 
Affairs, Office of Management and Budget,

Attention: CMS Desk Officer, CMS-3819-P
Fax: (202) 395-6974; or
Email: [email protected]

VI. Regulatory Impact Analysis

A. Introduction

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the 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 rule is a proposed 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 proposed rule would incorporate 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 proposed new CoPs is estimated to be $148 million 
in year 1 and $142 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 proposed rule would adopt 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 proposing to revise 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 proposed set of fundamental 
requirements for HHA services that would encompass patient rights, 
comprehensive patient assessment, and patient care planning and 
coordination by an interdisciplinary team. Overarching these 
requirements would be a QAPI program that would build on the philosophy 
that a provider's own quality management system is key to improved 
patient care performance.
    These proposed regulations contain two critical improvements that 
would support and extend our focus on patient-centered, outcome-
oriented surveys. First, the proposed regulations are designed to 
enable surveyors to look at outcomes of care, because the regulations 
would specify that each individual receive 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 would not only stimulate the HHA to 
continuously monitor its performance and find opportunities for 
improvement, it would also afford the surveyor the ability to assess 
how effectively the provider was pursuing a continuous quality 
improvement agenda. All of the changes would be directed toward 
improving patient-centered outcomes of care. We believe that the 
overall approach of the proposed CoPs would increase performance 
expectations for HHAs, in terms of achieving needed and desired 
outcomes for patients and increasing patient satisfaction with services 
provided.

C. Summary of Impacts

    Section V 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 
would be required by this proposed rule. That section, in tandem with 
this regulatory impact analysis section, present a full account of the 
burdens that would be imposed by this rule. Because the burdens have 
already been assessed in the Collection of Information Requirements 
section, we

[[Page 61195]]

will not recount them in this RIA section. In addition to analyzing the 
burden hours and associated costs for all burdens related to these 
proposed requirements, we have also assessed the potential savings 
associated with our proposal to remove certain outdated, burdensome 
requirements that exist in the current HHA CoPs. All estimates 
presented in this RIA section are based on the assumptions presented in 
Table 1, located at the beginning of the Section V of this rule, 
Collection of Information Requirements.

                           Table 3--Summary of Estimated Burden for All Proposed CoPs
----------------------------------------------------------------------------------------------------------------
                                                                                                 Annual cost in
                          CoP                                Total time       Total cost  in       year 2 and
                                                              (hours)             year 1           thereafter
----------------------------------------------------------------------------------------------------------------
Burden and Cost Estimates Associated with Information            2,786,178        $82,311,495        $79,291,233
 Collection Requirements...............................
Patient rights.........................................          2,349,960        144,074,520        144,074,520
QAPI...................................................            561,330         26,403,300         22,993,740
Infection prevention and control.......................            540,540         34,054,020         34,054,020
Removal of 60 day summary requirement..................           -887,592        -16,864,248        -16,864,248
Removal of Group of professional personnel requirement.           -192,868        -19,422,040      -19,422,04012
Removal of Evaluation of the agency's program..........         -1,359,953       -102,305,699       -102,305,699
                                                        --------------------------------------------------------
    Total..............................................          3,797,595        148,251,348        141,821,526
----------------------------------------------------------------------------------------------------------------

D. Detailed Economic Analysis

1. Burden Assessment
Reporting OASIS Information (Proposed Sec.  484.45)
    We propose only one change to this current CoP at Sec.  
484.45(c)(3). In this standard we propose to replace the requirement 
that an HHA have a direct telephone connection to transmit the OASIS 
data with a requirement at Sec.  484.45(c) that an HHA 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 proposed 
requirement does not impose a new burden upon HHAs.
Patient Rights (Proposed Sec.  484.50)
    The proposed rule would require that an agency would have to 
provide a patient and a patient's representative (if any) with a 
written notice of rights. 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.
    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, 1,860,000 
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 five 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 93 hours 
(1,116 patients x 5 minutes per patient/60 minutes), at a cost of 
$5,580 (1,116 patients x $5 per patient).
    For non-accredited HHAs, the requirement to provide this verbal 
notice would be a new requirement for all 1,488 patients served in an 
average HHA each year. The total cost of this provision per non-
accredited HHA would be $7,440 (1,488 patients x $5 per patient). The 
total number of hours per non-accredited HHA would be 124 hours (1,488 
patients x 5 minutes per patient/60 minutes). The total cost for all 
HHAs would be $79,459,200 ([$7,440 per non-accredited x 6,930 HHAs] + 
[$5,580 per accredited HHA x 5,000 HHAs]). The total number of hours 
for all HHAs would be 1,324,320 hours ([124 hours per non-accredited 
HHA x 6,930 HHAs] + [93 hours per non-accredited HHA x 5,000 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 1954, Section 504 of the Rehabilitation Act of 1973, the 
Age Discrimination Act of 1975, and ``other pertinent requirements of 
the Office of Civil Rights of HHS.'' HHS guidance, issued in 2003, 
further explains the expected role of translators 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 proposed requirement to communicate with patients in a 
language and manner that the patient understands would not impose a new 
burden on HHAs.
    Proposed Sec.  484.50(e) would require that all patient/family 
complaints be investigated. We estimate that, in a one year period, a 
HHA would need to investigate complaints involving about 5 percent (74) 
of its patients, and that each investigation would take 2 hours to 
complete. The total annual burden per HHA would be 148 hours (74 
investigations x 2 hour per investigation). All national accrediting 
organizations already require their

[[Page 61196]]

accredited HHAs to document, investigate, and resolve patient 
complaints; therefore all 5,000 accredited HHAs would not be burdened 
by this proposed requirement. The total annual burden hours for the 
industry would be 1,025,640 (148 hours per HHA x 6,930 non-accredited 
HHAs). The total annual cost for the QAPI coordinator to complete all 
investigations would be $9,324 per HHA ($63/hour x 148 hours), and 
$64,615,320 for all non-accredited HHAs ($46/hour x 1,025,640 hours).

                                             Table 4--Patient Rights
----------------------------------------------------------------------------------------------------------------
                                                   Time per HHA     Total time
                    Standard                          (hours)         (hours)      Cost per HHA     Total cost
----------------------------------------------------------------------------------------------------------------
Providing notice of rights (annual, non-                  124/93       1,324,320    $7,440/5,580     $79,459,200
 accredited/accredited HHAs)....................
Investigations (annual, non-accredited HHAs)....             148       1,025,640           9,324      64,615,320
                                                 ---------------------------------------------------------------
    Total (annual, non-accredited/accredited)...          272/93       2,349,960    16,764/5,580     144,074,520
----------------------------------------------------------------------------------------------------------------

Comprehensive Assessment of Patients (Proposed Sec.  484.55)
    We propose to retain 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 propose 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 (Proposed 
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,'' would be reorganized 
and revised at proposed Sec.  484.60.
    The change in Sec.  484.18, ``Acceptance of patients, plan of care, 
and medical supervision,'' would require HHAs to provide each patient 
with a written copy of the plan of care, including any additions or 
revisions. The plan of care would include all orders, would specify 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 would include all patient and caregiver education and 
training specific to the patient's needs. The intent of the current 
standard at Sec.  484.12(c) would be retained under this proposed CoP 
with the requirement that services be furnished in accordance with 
accepted standards of practice. No burden is associated with this part 
of the proposed CoP, as these requirements constitute current industry 
practices regarding plans of care.
    Proposed Sec.  484.60(a), ``Plan of care,'' would codify 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, ``Comprehensive 
assessment of patients.'' Therefore, this proposed requirement would 
not present a new burden.
    Proposed Sec.  484.60(b), ``Conformance with physician orders,'' 
would retain 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 would not impose a burden upon HHAs.
    This proposed standard also retains many of the current 
requirements regarding verbal orders with the exception of the proposed 
requirement at Sec.  484.60(b)(5), ``Conformance with physician 
orders,'' which would require 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 proposal.
    Proposed Sec.  484.60(c), ``Review and revision of the plan of 
care,'' would incorporate 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 proposed 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 proposed rule and the new standard would not constitute any new 
burden.
    Proposed Sec.  484.60(d), ``Coordination of care,'' would revise 
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.
Quality Assessment and Performance Improvement (QAPI) (Proposed 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 would further refine current HHA quality 
efforts and bring HHA quality programs in line with their counterparts 
in a variety of other settings, such as hospitals and hospices. 
Likewise, this rule would bring 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, the 
current quality-related standards established by the accrediting 
organizations would, we believe, even exceed those that we propose to 
require in this rule. Since

[[Page 61197]]

accredited HHAs would already have QAPI programs that 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 would provide a 
basic outline of what QAPI is and how we expect it to function in the 
HHA environment. Each HHA would be 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 would not be 
required to approach QAPI in this manner. The QAPI requirement would 
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 would:
    [cir] 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;
    [cir] Develop and revise policies and procedures to ensure that 
data is consistently collected, documented, retrieved, and analyzed in 
an accurate manner; and
    [cir] Educate HHA employees and contractors about the QAPI 
requirement, philosophy, policies, and procedures.
    In phase two, we believe that a HHA would:
    [cir] Enter data into patient clinical records during patient 
assessments;
    [cir] Aggregate data by collecting the same pieces of data from 
patient clinical records and other sources (for example, human resource 
records);
    [cir] 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
    [cir] 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 a HHA would:
    [cir] Identify new domains and measures that may replace or be in 
addition to the domains and measures already being monitored by the 
HHA;
    [cir] Develop and/or revise policies and procedures to accommodate 
the new domains and measures; and
    [cir] 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 would 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, a HHA is not required to 
use this title. For purposes of this analysis only, we assume that a 
HHA would 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 a HHA's resources. In phase one, we anticipate that 
an HHA would 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 would 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 would include the QAPI coordinator, the HHA 
administrator, and a clinical manager. We estimate that the QAPI 
committee would 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 would 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 $5,114,340 ($738 per HHA x 6,930 non-accredited HHAs).
    In addition to selecting measures and developing policies and 
procedures for QAPI activities, we anticipate that HHAs would 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 would 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 
would 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 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 x (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 166,320 (24 hours per average HHA 
x 6,930 non-accredited HHAs) and the total cost is $12,640,320 (166,320 
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 would 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,

[[Page 61198]]

timeliness of delivery of services). We estimate that, in order to 
ensure that the volume of gathered data was manageable, a HHA would 
have to gather its data once a month. A HHA could 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 would choose to gather data from a sample of clinical 
records. Likewise, some HHAs could 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 a 
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 would 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 $8,648,640 ($1,248 per 
HHA x 6,930 HHAs). Following data gathering and organization, a HHA 
would have to analyze the data to identify trends, patterns, anomalies, 
areas of strength and concern. We believe that this data analysis would 
be done by the QAPI committee described previously. In order to 
identify trends and patterns, the committee would need to examine 
several months of data at the same time. Therefore, we assume that the 
committee would 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 new 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 would impose a new burden.
    Performance improvement projects follow all of the data entry, 
gathering, organization, and analysis. A HHA would have to conduct 
projects to improve its performance in areas where a weakness was 
identified. Performance improvement projects would have to reflect the 
HHA's scope, complexity, and past performance. They would also have to 
be data-driven, and affect patient outcomes, patient safety, and 
quality of care. Although this rule would more clearly describe 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 a 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 would 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 such 
improved project efficiency and effectiveness may result in improved 
patient outcomes, 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 a 
HHA already has in place. We estimate that a HHA would use 3 hours a 
year to identify new domains and quality measures, and we believe that 
the QAPI committee would 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 
$1,704,780 ($246 per HHA x 6,930 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          62,370            $738      $5,114,340
Train staff (1st year and on-going).............              24         166,320           1,824      12,640,320
Aggregate data (1st year and on-going)..........              48         332,640           1,248       8,648,640
Update domains and measures (on-going)..........               3          20,790             246       1,704,780
                                                 ---------------------------------------------------------------
    Total 1st year..............................              81         561,330           3,810      26,403,300
                                                 ---------------------------------------------------------------
    Total yearly on-going.......................              75         519,750           3,318      22,993,740
----------------------------------------------------------------------------------------------------------------

Infection Prevention and Control (Proposed 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 a 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 proposed regulation would reinforce 
positive infection control practices and would address the serious 
nature, as well as the potential hazards, of infectious and 
communicable diseases in the home health environment. This rule would 
also bring 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

[[Page 61199]]

exceed those that we propose to require in this rule.
    Specifically, the regulation would require 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 would be 
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 would require HHA 
resources, and estimate that an HHA would 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 would 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, we believe that 
such a program would produce benefits for HHAs and their patients. For 
example, such 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, 
thus increasing staff productivity. We do not have adequate data from 
which to create accurate estimates of the potential benefits of this 
proposed 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         540,540          $4,914     $34,054,020
                                                 ---------------------------------------------------------------
    Total.......................................              78         540,540           4,914      34,054,020
----------------------------------------------------------------------------------------------------------------

Skilled Professional Services (Proposed Sec.  484.75)
    We would consolidate current provisions 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 would add 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 agency's QAPI program would impose little or no 
additional burden. We would also add 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 would 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 
would not impose a new burden upon HHAs.
Home Health Aide Services (Proposed Sec.  484.80)
    Home health aide services are an integral part of home health care, 
and the proposed 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 proposed 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 proposed 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 would be imposed by these proposed 
changes.
Compliance With Federal, State, and Local Laws and Regulations Related 
to Health and Safety of Patients (Proposed 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 would also be 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 would remain intact under this proposed rule. The burden 
associated with this provision would be 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 (Proposed Sec.  484.105)
    Several of the requirements currently found at Sec.  484.14, 
``Organization, services, and administration,'' have been reorganized 
and revised under this proposed condition. As previously discussed in 
the preamble to this proposed rule, the current standard at Sec.  
484.14(f), ``Personnel under hourly or per visit contracts,'' would be 
deleted. Additionally, as we have already discussed above in this 
section, the standards currently found at Sec.  484.14(e), ``Personnel 
policies,'' Sec.  484.14(g), ``Coordination of patient services,'' and 
Sec.  484.14(j), ``Laboratory services,'' would be reorganized with 
minor revisions under proposed Sec.  484.60(d), ``Coordination of 
care,'' Sec.  484.100(c),

[[Page 61200]]

``Laboratory services,'' and Sec.  484.105(c), ``Clinical manager,'' 
respectively.
    In order to facilitate compliance with Sec.  484.60(d) and to 
ensure that each patient's care is coordinated, we propose to combine, 
revise, and elaborate on current Sec.  484.14(d) and (e) at proposed 
Sec.  484.105(c), ``Clinical manager.'' This standard would require a 
qualified physician or registered nurse to provide oversight of all 
patient care services and HHA personnel. Oversight would include making 
patient and personnel assignments; coordinating patient care; 
coordinating referrals; assuring the development, implementation, and 
updates of the individualized plan of care; and developing personnel 
qualifications. The clinical manager role in the regulations would be a 
further refinement of the current ``Supervising physician or registered 
nurse'' role found in regulation at Sec.  418.14(d) and in statute at 
1861(o)(2) of the Act; 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 would 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 would be consolidated 
under the clinical manager position and would thus be a realignment of 
current resource allocations, we do not believe that this requirement 
would pose a new burden.
Clinical Records (Proposed Sec.  484.110)
    The current regulation at Sec.  484.48, ``Clinical records,'' would 
be revised, and reorganized under this proposed CoP. We believe that 
the majority of the revisions to the current clinical record 
requirement reflect contemporary professional standards already in 
place in the home health industry. Therefore, no additional burden 
would be imposed. In addition, the proposed requirements would 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 (Proposed Sec.  484.115)
    We would reorganize the personnel qualification requirements 
currently found at Sec.  484.4, ``Personnel qualifications,'' in a new 
CoP dedicated to personnel qualification standards. Within this new 
condition we propose to use the term ``licensed practical nurse'' 
instead of the current term of ``practical (vocational) nurse'' since 
the former is more commonly used and accepted. We also propose that the 
possession of any undergraduate degree would be sufficient for an 
administrator. In addition, we propose to expand 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 propose to defer 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 would create no new burden for HHAs.
2. Deleted Requirements
    We propose to delete three requirements of the current HHA 
regulations in their entirety. First, we would delete 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 currently 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 would save HHAs 
$16,864,248 each year. We would encourage agencies to assist the 
patient in seeking physician follow-up during each certification 
period.
    Second, we would delete Sec.  484.16, ``Group of professional 
personnel,'' because the QAPI requirements would address the same goals 
as are currently required of the group of professional personnel. This 
requirement currently 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 would also alleviate the burden of holding 
meetings with the group of professional 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 would be 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/hour), a therapist ($144), 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 $407 per meeting, or $1,628 per 
HHA per year ($407 per meeting x 4 meetings per year), for a total of 
190,880 hours (16 hours per HHA x 11,930 HHAs) at cost of $19,422,040 
($1,628 per HHA x 11,930 HHAs) per year. Therefore we estimate that the 
total reduction of burden would be 192,868 hours (190,880 hours + 1,988 
hours) and $19,459,812 ($19,422,040 + $37,772).
    Third, we would delete 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

[[Page 61201]]

of continuation of care. Each professional may review the records 
separately, at different times. For purposes of this analysis, we 
assume that a HHA would review a 5 percent sample of its clinical 
records, or an average of 75 clinical records per year per facility. 
Furthermore, for purposes of this analysis, we assume that a registered 
nurse ($63/hour), a therapist ($144/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 113 hours per year to meet this 
requirement, for a total of 1,348,090 hours for all HHAs. The total 
cost per record review is $114, or $8,550 per HHA per year, for a total 
of $102,001,500 for all HHAs. Therefore, we believe that removing this 
requirement would alleviate a total burden of 1,359,953 hours and 
$102,305,699.
3. Impact on Patient Care
    Although the positive effects of these proposed changes cannot be 
quantified, we note that the proposed changes are focused on improving 
the delivery of care to each and every patient. For example, the 
proposed QAPI standard would encourage 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 would 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

    The primary alternative considered for this rule was to not propose 
any changes to the health home conditions of participation and instead 
remain with the current regulations. However, in order to continuously 
improve care that is provided to all patients in the home health 
setting, CMS has chosen to propose the updates to the current 
regulations. If CMS made the decision not to propose these changes, 
there would be a savings of $142 million, annually, that would not be 
incurred by home health agencies because they would not be required to 
change current practices. However, as stated in the impact section of 
this rule, there is the potential for significant benefits, ranging 
from improved patient outcomes to increased staff productivity, which 
may be realized by HHAs as a result of improved practices and a higher 
quality patient care.

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 proposed 
rule for CY 2014.

          Table 7--Accounting Statement: Classification of Estimated Net Costs From FY 2015 to FY 2019
                                                  [in millions]
----------------------------------------------------------------------------------------------------------------
                                                                                       Units
                                                                 -----------------------------------------------
                    Category                         Estimates                     Discount rate      Period
                                                                    Year dollar         (%)           covered
----------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($million/year)........             138            2014               7       2015-2019
                                                             138            2014               3       2015-2019
----------------------------------------------------------------------------------------------------------------

    Although the benefits of these proposed changes cannot be 
quantified, we note that the proposed 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 
$14 million in any 1 year (for details, see the Small Business 
Administration's (SBA) Web site at http://www.sba.gov/sites/default/files/files/size_table_07222013.pdf (refer to the 620000 series). There 
are 11,930 Medicare-certified HHAs with average annual patient census 
of 1,488 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 proposed rule because the cost of this rule on 
a per-HHA basis is minimal (approximately a $20,500 net increase in 
burden per non-accredited HHA in the first year, and a small net 
savings of approximately $100 for accredited HHAs in the first year). 
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 Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 603 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of

[[Page 61202]]

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.

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 2014, that 
threshold is approximately $141 million. It includes no mandates on 
state, local, or tribal governments. The estimates presented in this 
section of the proposed 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 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 proposed regulation is subject to the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress 
and the Comptroller General for review.
    In accordance with the provisions of Executive Order 12866, this 
proposed rule was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 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 proposes to amend 42 CFR Chapter IV as set forth 
below:

PART 409--HOSPITAL INSURANCE BENEFITS

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

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

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
2. 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).

PART 418--HOSPICE CARE

0
3. 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).

PART 440--SERVICES: GENERAL PROVISIONS

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

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

0
5. 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)..................  Sec.   484.14(h).....  Sec.   484.105(e).
Sec.   410.62.................  (a) introductory text  Sec.   484.4.........  Sec.   484.115.
Sec.   418.76.................  (f)(1)...............  Sec.   484.36(a) and   Sec.   484.80.
                                                        Sec.   484.36(b).
Sec.   418.76.................  (f)(2)...............  Sec.   484.36(a).....  Sec.   484.80(a).
Sec.   440.110................  (a)(2) and (b)(2)....  Sec.   484.4.........  Sec.   484.115 of this chapter.
----------------------------------------------------------------------------------------------------------------

PART 484--HOME HEALTH SERVICES

0
6. 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
7. 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 
outcome and assessment information set (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.

[[Page 61203]]

484.75 Condition of participation: Skilled professional services.
484.80 Condition of participation: Home health aide services.
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.
484.105 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), 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 guardian or other person 
who participates in making decisions related to the patient's care or 
well-being, including but not limited to, a person chosen by the 
patient, 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 outcome and assessment information set (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 state agency 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 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. Written notice must be understandable to persons who 
have limited English proficiency and accessible to individuals with 
disabilities; and
    (ii) 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.
    (2) Provide contact information for the HHA administrator, 
including the administrator's name, business address,

[[Page 61204]]

and business phone number in order to receive complaints or questions.
    (3) Provide the OASIS privacy notice to all patients for whom the 
OASIS data is collected.
    (4) Obtain the patient's or representative's signature confirming 
that he or she has received a copy of the notice of rights and 
responsibilities.
    (b) Standard: Exercise of rights. (1) If a patient has been 
adjudged incompetent under 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 incompetent, the 
patient's representative may exercise the patient's rights.
    (3) If a patient has been adjudged to lack legal capacity 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 the comprehensive assessment;
    (ii) The care to be furnished, based on the comprehensive 
assessment;
    (iii) Establishing and revising the plan of care, including 
receiving a copy of it;
    (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 (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 
pertinent, Federally-funded and State-funded, State and local consumer 
information, consumer protection, and advocacy agencies.
    (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 admission, transfer, and discharge in advance of care 
being furnished. 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 ensure 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 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;
    (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 (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 who 
is responsible 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--
    (i) Investigate complaints made by a patient, the patient's 
representative (if any), and the patient's caregivers and family 
regarding the following:
    (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

[[Page 61205]]

    (iii) Take action to prevent further potential violations 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.
    (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;
    (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 five 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 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 that the HHA will provide, 
specific to the patient's care needs. 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

[[Page 61206]]

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) Patient and caregiver education and training to facilitate 
timely discharge;
    (xiii) Patient-specific interventions and education; measurable 
outcomes and goals identified by the HHA and the patient;
    (xiv) Information related to any advanced directives; and
    (xv) Any additional items the HHA or physician may choose to 
include.
    (3) If HHA services are initiated following the patient's discharge 
from a hospital, the individualized plan of care must include a 
description of the patient's risk for emergency department visits and 
hospital re-admission (low, medium, high) and all necessary 
interventions to address the underlying risk factors.
    (4) 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 the 
physician who is responsible for the home health plan of care.
    (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 registered nurse, 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 physician who is responsible 
for the HHA plan of care 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 the physician who is responsible 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, 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).
    (d) Standard: Coordination of care. (1) 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.
    (2) The HHA coordinates care delivery to meet the patient's needs, 
and involves the patient, representative (if any), and caregiver(s), as 
appropriate, in the coordination of care activities.
    (3) The HHA must 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: Discharge or transfer summary. The discharge or 
transfer summary must include--
    (1) A summary of the patient's stay, including the reason for 
referral to the HHA, the patient's clinical, mental, psychosocial, 
cognitive, and functional condition at the time of the start of 
services by the HHA, all services provided by the HHA, the start and 
end date of care by the HHA, the patient's clinical, mental, 
psychosocial, cognitive, and functional condition at the time of 
discharge from the HHA, an updated reconciled list of medications at 
the time of discharge or transfer, and any recommendations for ongoing 
care (for example, outpatient physical therapy);
    (2) The patient's current plan of care, including the latest 
physician orders; and
    (3) Any other documentation that will assist in post-discharge or 
transfer continuity of care, or that is requested by the health care 
practitioner who will be responsible for providing care and services to 
the patient after discharge from the HHA or receiving facility.


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 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 
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

[[Page 61207]]

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. (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 the physician who is responsible for the 
home health 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(j).
    (2) Rehabilitative therapy services are provided under the 
supervision of an occupational therapist or physical therapist that 
meets the requirements of Sec.  484.115(e) or (g), respectively.
    (3) Medical social services are provided under the supervision of a 
social worker that meets the requirements of Sec.  484.115(l).


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. Sec.  483.151 
through 483.154 of this chapter, and is 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

[[Page 61208]]

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, 
including pressure ulcers; 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 l2 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
    (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

[[Page 61209]]

appropriate skilled professional. Written patient care instructions for 
a home health aide must be prepared by a registered nurse or other 
appropriate skilled professional (that is, physical therapist, speech-
language pathologist, or occupational therapist) who is responsible for 
the supervision of a home health aide as specified under paragraph (h) 
of this section.
    (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 
described in paragraph (g) of this section 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 a potential deficiency 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. Sec.  420.201, 
420.202, and 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. Sec.  420.201, 420.202, and 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.
    (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

[[Page 61210]]

in accordance with the applicable requirements of part 493 of this 
chapter.


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 overcoming those deficits that led to the patient's need for 
home health services, for each patient's medical, nursing, and 
rehabilitative needs as indicated by the plan of care. 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 the governing body;
    (ii) Be responsible for all day-to-day operations of the HHA;
    (iii) Ensure that a skilled professional as described in Sec.  
484.75 is available during all operating hours.
    (2) When the administrator is not available, a 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 skilled 
professional as described in paragraph (b)(1)(iii) of this section.
    (3) The administrator or pre-designated individual is available 
during all operating hours.
    (c) Clinical manager. A qualified licensed physician or registered 
nurse 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;
    (5) Assuring the development, implementation, and updates of the 
individualized plan of care; and
    (6) Assuring the development of personnel qualifications and 
policies.
    (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. Sec.  485.711, 485.713, 485.715, 
485.719, 485.723, and 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, 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

[[Page 61211]]

(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 who is responsible 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 and the patient's 
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 completed discharge or transfer summary, as required by Sec.  
484.60(e), 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 7 
calendar days of the patient's discharge; or, if the patient's care 
will be immediately continued in a health care facility, a discharge or 
transfer summary is sent to the facility within 2 calendar days of the 
patient's discharge or 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 personal 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 and appropriately authorized individuals or entities upon 
request.


Sec.  484.115  Condition of participation: Personnel qualifications.

    HHA staff are required to meet the following standards:
    (a) Standard: Administrator, home health agency. A person who:
    (1) Is a licensed physician, a registered nurse, or holds an 
undergraduate degree; and
    (2) Has experience in health service administration, with at least 
one year of supervisory or administrative 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: 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.
    (d) Standard: Licensed practical nurse. A person who has completed 
a practical nursing program, is licensed in the state where practicing, 
and who furnishes services under the supervision of a qualified 
registered nurse.
    (e) 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

[[Page 61212]]

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 assistant 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.
    (f) 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 
(b)(6)(i) 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 National Board for Certification in Occupational 
Therapy, Inc. (NBCOT).
    (ii) [Reserved]
    (g) 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) Graduated after successful completion of a physical therapist 
education program approved by one of the following:
    (i) The Commission on Accreditation in Physical Therapy Education 
(CAPTE).
    (ii) Successor organizations of CAPTE.
    (iii) 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.
    (iv) 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--
    (i) Graduated from a physical therapy curriculum approved by one of 
the following:
    (A) The American Physical Therapy Association.
    (B) The Committee on Allied Health Education and Accreditation of 
the American Medical Association.
    (C) The Council on Medical Education of the American Medical 
Association and the American Physical Therapy Association.
    (ii) [Reserved]
    (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;

[[Page 61213]]

    (ii) Was admitted to registration by the American Registry of 
Physical Therapists; and
    (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.
    (h) 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) 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); 
or
    (2) Passed a national examination for physical therapist assistants 
on or before December 31, 2009, and 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 (b)(8) of this section.
    (iii) 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.
    (iv) 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.
    (i) 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.
    (j) Standard: Registered nurse. A graduate of an approved school of 
professional nursing who is licensed in the state where practicing.
    (k) 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.
    (l) 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.
    (m) 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);
    (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
8. 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)).

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

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

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

0
10. 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.   485.58................  Introductory text....  484.4...............  484.115.
Sec.   485.70................  (c) and (e)..........  Sec.   484.4........  Sec.   484.115.
Sec.   488.805...............  Definition of          Sec.  Sec.   484.4    Sec.  Sec.   484.105(b) and 484.115.
                                ``temporary            and 484.14(c).
                                management''.
----------------------------------------------------------------------------------------------------------------


    Dated: June 17, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.


    Dated: July 11, 2014.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2014-23895 Filed 10-6-14; 4:15 pm]
BILLING CODE 4120-01-P