Vol. 79 Thursday, 

No. 196 October 9, 2014 

Part III 

Department of Health and Human Services 

Centers for Medicare and Medicaid Services 

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

Medicare and Medicaid Program: Conditions of Participation for Home 

Health Agencies; Proposed Rule 

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61164 Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Proposed Rules 

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. 

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. 

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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 CMSapproved 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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61166 Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Proposed Rules 

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: 

D 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. 

D 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. 

D 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. 

D 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 § 484.55, 

Comprehensive assessment of patients): 

D ‘‘Patient rights’’ would emphasize a 

HHA’s responsibility to respect and 

promote the rights of each home health 

patient. 

D ‘‘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. 

D ‘‘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. 

D ‘‘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 

§ 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. 

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

§ 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 § 484.200 as the basis 

for subpart E of this part, Prospective 

Payment System for Home Health 

Agencies, therefore, we propose to 

delete § 484.1(a)(3). 

At § 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 statespecific 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 

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61168 Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Proposed Rules 

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 § 484.4, 

‘‘Personnel qualifications,’’ under 

proposed subpart A, General Provisions. 

These modifications would be set forth 

under proposed § 484.80, ‘‘Home health 

aide services,’’ and proposed § 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 

§ 484.40) 

At § 484.40, we propose to recodify 

the current requirements of § 484.11, 

which require an HHA and its agents to 

ensure the confidentiality of all patientidentifiable information in the clinical 

record, including the OASIS data. 

2. Reporting OASIS Information 

(Proposed § 484.45) 

In this CoP, we propose to include 

most of the current requirements of 

§ 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 § 484.50) 

At § 484.50, we propose to redesignate and modify the patient rights 

provisions that are found at current 

§ 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 § 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 

§ 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 

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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 § 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 

§ 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-PatientAssessment-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 § 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 § 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 § 484.50(b), ‘‘Exercise of 

rights’’ and at § 484.50(c), ‘‘Rights of the 

patient.’’ Under proposed § 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, patientdirected 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 § 484.50(c) would set forth 

the explicit rights of each home health 

patient. At § 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 § 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 § 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 § 484.50(c)(4), patients and 

their representatives would also have 

the right to participate in, be informed 

about, and consent or refuse care. 

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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 § 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 § 484.60. HHAs would be 

required at § 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 

§ 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 

§ 484.10(d), which concern the patient’s 

right to the confidentiality of his or her 

clinical records, under proposed 

§ 484.50(c)(6). In order to maintain 

confidentiality within the patient’s 

home, as we are proposing at 

§ 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 § 484.50(c)(7), would retain 

the requirements of the current standard 

at § 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 

§ 411.408(d)(2) and § 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 nonMedicare 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 § 489.53(a)(2). 

At proposed § 484.50(c)(8), we would 

retain the basic concept of the 

requirement at current § 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 § 484.10(f), regarding the home 

health hotline at proposed 

§ 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 tollfree 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 § 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 § 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 § 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 

§ 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 § 484.50(d)(1), if the care 

needs of a patient exceeded the HHA’s 

ability to provide services, the HHA 

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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 § 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 

§ 484.50(e), ‘‘Investigation of 

complaints,’’ that would expand upon 

the current complaint investigation 

requirements at § 484.10(b)(5). Proposed 

§ 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 § 484.50(e)(1)(ii) would 

require the HHA to document both the 

existence and the resolution of the 

complaint, while § 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 § 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 § 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 § 484.55) 

We propose to retain the majority of 

the substantive requirements of current 

§ 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 § 484.55(d), with one change. 

Currently § 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 

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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 

§ 484.55(d)(2) to allow for a physicianordered 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 

§ 484.60) 

Current regulations concerning the 

plan of care are set forth at § 484.18, 

‘‘Acceptance of patients, plan of care, 

and medical supervision.’’ We propose 

to revise that requirement, as well as 

current § 484.14(g), ‘‘Coordination of 

patient services,’’ by creating a new 

condition of participation, ‘‘Care 

planning, coordination of services, and 

quality of care’’ at § 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 § 484.60(a); (2) 

conformance with physician orders at 

§ 484.60(b); (3) review and revision of 

the plan of care at § 484.60(c); (4) 

coordination of care at § 484.60(d); and 

(5) discharge or transfer summary at 

§ 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 § 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 § 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 § 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 § 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/article

render.fcgi?artid=1637042) The shared 

decision making model has been 

embraced in literature (‘‘Decisionmaking 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, patientspecific 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 

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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.homehealth

quality.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 § 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 § 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 § 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 § 484.60(b)(2). 

Proposed § 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 

§ 484.18(c) by proposing at 

§ 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 § 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 § 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 

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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 § 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 patientspecific 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 § 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 § 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 

§ 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 

§ 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 followup 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 selfadminister 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 § 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 followup 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. 

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6. Quality Assessment and Performance 

Improvement (QAPI) (Proposed 

§ 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, afterthe-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, 

§ 484.16, ‘‘Group of professional 

personnel,’’ and § 484.52, ‘‘Evaluation of 

the agency’s program,’’ with a single, 

new CoP, at § 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 (§ 494.110), 

hospitals (§ 482.21), hospices (§ 418.58), 

organ procurement organizations 

(§ 486.348), and transplant centers 

(§ 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 problemoriented, 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 § 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 § 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 § 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 § 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 highvolume. 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 upto-date on the latest techniques. 

Likewise, wound care could be a highvolume 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 § 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 § 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 

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61176 Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Proposed Rules 

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 outcomebased quality improvement (OBQI), 

outcome-based quality management 

(OBQM), and process based quality 

improvement (PBQI) reports. Case-mixadjusted 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 § 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 

§ 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 § 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 § 484.70) 

In the current HHA CoPs, there is no 

requirement for an HHA-wide infection 

control program; however the current 

regulation at § 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 § 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 

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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 § 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 § 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§ion=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 § 484.70(c). 

HHAs would be expected to provide 

education on ‘‘current best practices’’ to 

staff, patients, and caregivers. This 

could be accomplished through inservice 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/bloodglucose-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 § 484.75) 

This proposed new condition would 

consolidate and revise current 

conditions at § 484.30, ‘‘Skilled nursing 

services’’; § 484.32, ‘‘Therapy services’’; 

and § 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 

§ 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 

§ 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 § 484.115, 

‘‘Personnel qualifications,’’ and who 

practice according to the HHA’s policies 

and procedures. 

We propose in § 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); 

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• 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 HHAsponsored 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 

§ 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 

§ 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 § 484.115. 

9. Home Health Aide Services (Proposed 

§ 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 

§ 484.36. In this rule, we propose to 

retain the current requirements while 

making clarifying and organizational 

changes to § 484.36. As part of our 

reorganization, this revised condition 

would be re-located at proposed 

§ 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 § 484.4. In this proposed rule, 

these requirements would now be 

organized as nine standards under 

proposed § 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 

§ 484.4, Personnel qualifications. We 

believe these specific qualifications 

would be more appropriately located in 

the section covering home health aide 

services. At proposed § 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 

§ 484.80(b) and § 484.80(c); or (2) a 

competency evaluation program that 

meets the requirements described in 

§ 484.80(c); or (3) a nurse aide training 

and competency evaluation program 

that is approved by the state as meeting 

the requirements of § 483.151 through 

§ 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 § 484.80(b) 

and § 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 § 484.80(a)(2), we 

would retain the intent of the current 

requirement at § 484.4, and specify 

when a home health aide is deemed to 

have completed a program (as specified 

in proposed § 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 

§ 484.80(a)(1). 

In this rule, we propose to retain the 

requirements for content and duration 

of training from current § 484.36(a). 

However, we have clarified this section. 

We propose, at § 484.80(b), to set forth 

the requirements for training content 

and its duration, training methods 

(classroom and practical), and training 

documentation. Proposed § 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 

§ 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 § 484.80(e) and § 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 § 484.2, 

Definitions. 

The current requirement at 

§ 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, 

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we would require at § 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 § 484.80(b)(4), we propose to retain 

the current provision at § 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 § 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 § 484.36(b) into two 

separate standards, § 484.80(c) 

Competency evaluation, and § 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 

§ 484.80(c). We propose to retain the 

requirement currently found at 

§ 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 (§ 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 § 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 

§ 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 

§ 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 § 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 § 484.80(c), and inservice training at proposed § 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 § 484.80(h)), would provide an 

environment conducive to safe and 

appropriate patient care. Further, by 

continuing to emphasize ongoing inservice 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 

§ 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 inservice training to the unique needs of 

the population it serves. 

We would retain the requirements in 

this proposed rule that aide in-service 

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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 § 484.36(a)(2)(i) 

regarding organizations that offer aide 

training (generally, HHAs), with some 

revision and reorganization under a new 

standard at § 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 § 484.80(g), Home 

health aide assignments and duties, to 

set forth aide responsibilities and 

duties, and are retaining most of current 

§ 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 § 484.60, Care 

planning, coordination of services, and 

quality of care). 

Proposed § 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 § 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 § 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 § 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 § 484.80(g)(3), we propose to retain 

the inclusive listing of duties for home 

health aides currently under 

§ 484.36(c)(2). 

At § 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 § 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 § 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 

§ 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 § 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 

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the aide’s patient care knowledge and 

skills. 

In proposed § 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 § 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 § 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 § 484.80(h)(5) would 

retain, with minor revisions, the current 

requirements found under § 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 § 484.80(i), Individuals 

furnishing Medicaid personal care aideonly services under a Medicaid personal 

care benefit, we propose to retain the 

requirements at current § 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 § 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 § 440.170 in 

the current regulation at § 484.36(e)(2) is 

incorrect; it should read § 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 

§ 484.100) 

Provisions concerning compliance 

with federal, state, and local laws are 

presently located at current § 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 

§ 484.100. 

We propose to incorporate the 

standard at current § 484.12(a) into the 

general opening statement of the 

condition at § 484.100. At proposed 

§ 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 § 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 selfexplanatory, 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 § 484.12(a) and incorporate 

them into the proposed state licensure 

standard at § 484.100(b). Under the 

provisions of proposed § 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 § 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 

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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 § 484.14(j), 

Laboratory services, to § 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 selfadministered testing equipment, such as 

glucometers, in lieu of a patient’s selfadministered 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 selfadministered 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 selfadministered 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 § 484.105) 

This proposed CoP on organization 

and administration of services would 

revise current regulations at § 484.14, 

‘‘Organization, services, and 

administration.’’ As previously 

discussed, the current regulation at 

§ 484.14(g), ‘‘Coordination of patient 

services,’’ would be relocated and 

revised under proposed § 484.60. In 

addition, the current regulations found 

at § 484.38, ‘‘Qualifying to furnish 

outpatient physical therapy or speech 

pathology services,’’ would be relocated 

to § 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 § 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 § 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 § 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 § 484.75 is 

available during all operating hours. 

The current State Operations Manual 

(Pub 100–7, Appendix B, http://

cms.hhs.gov/Regulations-andGuidance/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 

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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 predesignated 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 § 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 § 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 § 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 § 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 parentbranch 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 § 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 statespecific 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 

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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 § 484.14(h) governing 

services under arrangement would be 

retained with a minor revision in the 

proposed standard at § 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 crossreference citation for the United States 

Code. 

We propose to move the current 

standard at § 484.14(a), ‘‘Services 

furnished,’’ to § 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 parttime 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 § 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 § 484.12(c), 

‘‘Compliance with accepted professional 

standards and principles,’’ at 

§ 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 § 484.38, ‘‘Qualifying to 

furnish outpatient physical therapy or 

speech pathology services,’’ to 

§ 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 § 484.14(i) and as 

required for HHAs under § 1861(z) of 

the Act. We would retain this standard 

at § 484.105(h) without any revisions. 

3. Clinical Records (Proposed § 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 § 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 § 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 outcomeoriented approach to patient care. 

Specifically, at proposed § 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, 

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services, and responses to those 

interventions, which would be dated 

and timed in accordance with the 

requirements of proposed § 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 

§ 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 § 484.110(c), we 

would revise the current requirements 

under § 484.48(a), ‘‘Retention of 

records.’’ With proposed § 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 

§ 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 § 484.110(d) to incorporate 

into this condition the requirement 

under current § 484.48(b), ‘‘Protection of 

records,’’ relative to the safeguarding of 

information. At proposed § 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 § 484.48(b), concerning the 

release of clinical record information, is 

best incorporated into the proposed 

standard at § 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 § 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 HIEfocused 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, 

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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/policyresearchers-implementers/standardsand-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 (§ 170.314(b)(1) and 

§ 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 postacute 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® 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 

§ 484.115) 

Currently, provisions concerning the 

qualifications of HHA personnel are 

located at § 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, 

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we propose revisions to the organization 

of the ‘‘Personnel qualifications’’ CoP. 

Many other provider types crossreference the HHA personnel 

requirements, and we are proposing 

conforming amendments accordingly. 

Under our proposed reorganization of 

part 484, personnel qualifications would 

be located at § 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 § 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 § 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 

§ 484.30, § 484.32, and § 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 § 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 § 484.105(a), the governing body 

would be responsible for appointing a 

qualified administrator, subject to the 

proposed requirements at § 484.115(a). 

If the governing body believed 

additional qualifications were required 

for an administrator, it could include 

these in its hiring criteria. 

At § 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 speechlanguage 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. 

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61188 Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Proposed Rules 

Current CoPs Revised CoPs 

§ 484.1, Basis and scope ....................................................................... Revised at § 484.1. 

§ 484.2, Definitions ................................................................................. Revised at § 484.2. 

§ 484.4, Personnel qualifications .......................................................... Revised at § 484.115. 

Home health aide qualifications ............................................................... Revised at § 484.80. 

§ 484.10, Patient rights ........................................................................... § 484.50, Patient rights. 

484.10(a) .................................................................................................. Revised at § 484.50(a). 

484.10(b) .................................................................................................. Revised at §§ 484.50(b), (c), and (e). 

484.10(c) ................................................................................................... Revised at § 484.50 (c). 

§ 484.10(d) ................................................................................................ Revised at § 484.50(c). 

§ 484.10(e) ................................................................................................ Revised at § 484.50(c). 

§ 484.10(f) ................................................................................................. Revised at § 484.50(c). 

New standard at § 484.50(d), Transfer and discharge. 

New standard at § 484.50(e), Investigation of complaints. 

§ 484.11, Release of patient identifiable OASIS information ............. § 484.40, Release of patient identifiable outcome and assessment 

information set (OASIS) information. 

§ 484.12, Compliance with Federal, State, and local laws, disclosure and ownership information, and accepted professional 

standards and principles.

§ 484.100, Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. 

§ 484.12(a) ................................................................................................ Revised at § 484.100 and § 484.100(b). 

§ 484.12(b) ................................................................................................ Redesignated at § 484.100(a). 

§ 484.12(c) ................................................................................................ Revised at § 484.60, § 484.70, and § 484.105(f). 

§ 484.14, Organization, services, and administration ......................... § 484.105, Organization and administration of services. 

§ 484.14(a) ................................................................................................ Revised at § 484.105(f). 

§ 484.14(b) ................................................................................................ Revised at § 484.105(a). 

§ 484.14(c) ................................................................................................ Revised at § 484.105(b). 

§ 484.14(d) ................................................................................................ Revised at § 484.75(d), § 484.105(b), and § 484.105(c). 

§ 484.14(e) ................................................................................................ Revised at § 484.75(b) and § 484.115. 

§ 484.14(f) ................................................................................................. Revised at § 484.105(e). 

§ 484.14(g) ................................................................................................ Revised at § 484.60(d) and § 484.105(c). 

§ 484.14(h) ................................................................................................ Revised at § 484.105(e). 

§ 484.14(i) ................................................................................................. Revised at § 484.105(h). 

§ 484.14(j) ................................................................................................. Revised at § 484.100(c). 

§ 484.16, Group of professional personnel .......................................... Deleted, see § 484.65, Quality assessment and performance improvement (QAPI). 

§ 484.18, Acceptance of patients, plan of care, and medical supervision.§ 484.60, Care planning, coordination of services, and quality of 

care. 

§ 484.18(a) ................................................................................................ Revised at § 484.60(a). 

§ 484.18(b) ................................................................................................ Revised at § 484.60(c). 

§ 484.18(c) ................................................................................................ Revised at § 484.60(b). 

§ 484.20, Reporting OASIS information ................................................ § 484.45, Reporting OASIS information. 

§ 484.30, Skilled nursing services ........................................................ § 484.75, Skilled professional services. 

§ 484.32, Therapy services .................................................................... § 484.75, Skilled professional services. 

§ 484.34, Medical social services .......................................................... § 484.75, Skilled professional services. 

§ 484.36, Home health aide services .................................................... § 484.80, Home health aide services. 

§ 484.36(a)(1) ........................................................................................... Revised at § 484.80(b). 

§ 484.36(a)(2)(i) ........................................................................................ Revised at § 484.80(f). 

§ 484.36(a)(2)(ii) ....................................................................................... Revised at § 484.80(e). 

§ 484.36(a)(3) ........................................................................................... Revised at § 484.80(b). 

§ 484.36(b)(1) ........................................................................................... Revised at § 484.80(c). 

§ 484.36(b)(2)(i) ........................................................................................ Revised at § 484.80(c). 

§ 484.36(b)(2)(ii) ....................................................................................... Revised at § 484.80(h). 

§ 484.36(b)(2)(iii) ....................................................................................... Revised at § 484.80(d).

§ 484.36(b)(3)(i) ........................................................................................ Revised at § 484.80(c) and (d). 

§ 484.36(b)(3)(ii) ....................................................................................... Revised at § 484.80(c) and (d). 

§ 484.36(b)(3)(iii) ....................................................................................... Revised at § 484.80(c).

§ 484.36(b)(4) ........................................................................................... Revised at § 484.80(c). 

§ 484.36(b)(5) ........................................................................................... Redesignated at § 484.80(c). 

§ 484.36(b)(6) ........................................................................................... Deleted. 

§ 484.36(c) ................................................................................................ Revised at § 484.80(g). 

§ 484.36(d) ................................................................................................ Revised at § 484.80(h). 

§ 484.36(e) ................................................................................................ Revised at § 484.80(i). 

§ 484.38, Qualifying to furnish outpatient physical therapy or 

speech pathology services.

Revised at § 484.105(g). 

§ 484.48, Clinical records ....................................................................... § 484.110, Clinical records. 

§ 484.48(a) ................................................................................................ Revised at § 484.110(c). 

§ 484.48(b) ................................................................................................ Revised at § 484.110(d). 

New standard at § 484.110(a), Contents of clinical record. 

New standard at § 484.110(b), Authentication. 

New standard at § 484.110(e), Retrieval of clinical records. 

§ 484.52, Evaluation of the agency’s program .................................... Deleted, see § 484.65, Quality assessment and performance improvement and § 484.70, Infection prevention and control. 

§ 484.55, Comprehensive assessment of patients .............................. § 484.55, Comprehensive assessment of patients. 

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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 nationwide .................................................................................................... 17,751,840 

Number of HHA patients in Medicare participating, accredited HHAs ................................................................................................... 7,440,000 

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, Therapist) * ................................................................................................................. $76 

* 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 (§ 484.45) 

Proposed § 484.45 states that HHAs 

must electronically report all OASIS 

data in accordance with § 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 (§ 484.50) 

Proposed § 484.50 would implement 

the patient rights provisions of section 

1891(a)(1) of the Act, which are 

currently specified in § 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 § 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 § 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 

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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 § 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 Medicareapproved, 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 

§ 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 × 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 (§ 484.55) 

Proposed § 484.55 would require the 

HHA to conduct, document and update, 

within a defined timeframe, a patientspecific 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 disciplinespecific licensure requirements. 

D. ICRs Regarding Condition of 

Participation: Care Planning, 

Coordination of Services, and Quality of 

Care (§ 484.60) 

The proposed requirements in this 

section would reflect an 

interdisciplinary, coordinated approach 

to home health care delivery. Proposed 

§ 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 § 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 § 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 × 

5 minutes]/60 minutes per hour). 

Proposed § 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 § 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 

§ 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 

§ 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. 

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E. ICRs Regarding Condition of 

Participation: Quality Assessment and 

Performance Improvement (QAPI) 

(§ 484.65) 

Proposed § 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 

§ 484.16, ‘‘Group of professional 

personnel,’’ and § 484.52, ‘‘Evaluation of 

an agency’s program.’’ 

The first standard under § 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 

§ 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 × 6,930 nonaccredited HHAs), and an industry-wide 

cost of $1,746,360 (27,720 hours × $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 (§ 484.70) 

Proposed § 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 § 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 § 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 careacquired 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 (§ 484.75) 

We propose to consolidate current 

provisions governing skilled nursing 

services at § 484.30, therapy services at 

§ 484.32, and medical social services at 

§ 484.34, under one new condition, 

§ 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 § 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 

§ 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 § 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 (§ 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 § 484.36, but place them in a 

new condition of participation at 

§ 484.80. We would also add the 

provisions from § 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 

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qualifications as specified in proposed 

§ 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 × 2 aides per HHA]/60 minutes 

per hour × 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 × $26/ 

hour). 

Proposed § 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 § 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 × 2 aides per HHA]/ 

60 minutes per hour × 11,930 HHAs). 

The cost burden associated with this 

requirement is $51,688, based on an 

office employee completing the 

documentation ($26/hour × 1,988 

hours). 

Proposed § 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 § 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 × 2 aides per HHA]/ 

60 minutes per hour × 11,930 HHAs). 

The cost burden associated with this 

requirement is $51,688, based on an 

office worker completing the 

documentation ($26/hour × 1,988 

hours). 

Proposed § 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 × 4 trainings per year × 6 aides]/ 

60 minutes per hour). The estimate total 

annual burden for this requirement is 

23,860 hours (2 hours per HHA × 11,930 

HHAs). 

Proposed § 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 § 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 (§ 484.100) 

Provisions concerning compliance 

with federal state, and local laws are 

currently located at § 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 § 484.100. 

As stated in proposed § 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 § 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 

§ 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 (§ 484.105) 

This proposed section would set forth 

the organization and administration of 

services provided by a HHA. It would 

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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 § 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 § 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 11⁄2

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 

(§ 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 § 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 (§ 484.115) 

In § 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

Regulation 

section 

OMB Control 

No. Respondents Responses 

Burden per 

response 

(in hours) 

Total annual 

burden 

(in hours) 

Hourly labor 

cost of 

reporting 

($) 

Total cost of 

reporting 

($) 

Total costs 

($) 

§ 484.50(a) * .. 0938—New ... 65 65 8 * 520 98 50,960 50,960 

§ 484.50(a) * .. 0938—New ... 11,930 11,930 1 * 11,930 98 1,169,140 1,169,140 

§ 484.50(e) .... 0938—New ... 6,930 512,820 0.083 42,735 63 2,692,305 2,692,305 

§ 484.60(a) .... ....................... 11,930 14,268,280 0.083 1,189,023 26 36,914,598 36,914,598 

§ 484.65(e) * .. 0938—New ... 6,930 6,930 4 * 27,720 63 1,746,360 1,746,360 

§ 484.80(a) .... 0938—New ... 11,930 23,860 0.083 1,988 26 51,688 51,688 

§ 484.80(b) .... 0938—New ... 11,930 23,860 0.083 1,988 26 51,688 51,688 

§ 484.80(c) ..... 0938—New ... 11,930 23,860 0.083 1,988 26 51,688 51,688 

§ 484.80(d) .... 0938—New ... 11,930 286,320 0.083 23,860 26 620,360 620,360 

§ 484.100(a) .. 0938—New ... 11,930 11,930 0.083 994 98 97,412 97,412 

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TABLE 2—BURDEN AND COST ESTIMATES ASSOCIATED WITH INFORMATION COLLECTION REQUIREMENTS—Continued 

Regulation 

section 

OMB Control 

No. Respondents Responses 

Burden per 

response 

(in hours) 

Total annual 

burden 

(in hours) 

Hourly labor 

cost of 

reporting 

($) 

Total cost of 

reporting 

($) 

Total costs 

($) 

§ 484.100(a) * 0938—New ... 549 549 1 * 549 98 53,802 53,802 

§ 484.105(h) .. ....................... 6,930 6,930 0.5 3,465 98 339,570 339,570 

§ 484.105(h) .. ....................... 65 65 1.5 98 98 9,604 9,604 

§ 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: OIRA_submission@omb.eop.gov 

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 patientcentered, 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 

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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

CoP Total time 

(hours) 

Total cost 

in year 1 

Annual cost 

in year 2 

and thereafter 

Burden and Cost Estimates Associated with Information Collection Requirements 2,786,178 $82,311,495 $79,291,233 

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 

§ 484.45) 

We propose only one change to this 

current CoP at § 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 

§ 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 § 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 endstage 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 × $63/ 

hour). The total number of hours per 

accredited HHA would be 93 hours 

(1,116 patients × 5 minutes per patient/ 

60 minutes), at a cost of $5,580 (1,116 

patients × $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 × $5 per 

patient). The total number of hours per 

non-accredited HHA would be 124 

hours (1,488 patients × 5 minutes per 

patient/60 minutes). The total cost for 

all HHAs would be $79,459,200 ([$7,440 

per non-accredited × 6,930 HHAs] + 

[$5,580 per accredited HHA × 5,000 

HHAs]). The total number of hours for 

all HHAs would be 1,324,320 hours 

([124 hours per non-accredited HHA × 

6,930 HHAs] + [93 hours per nonaccredited HHA × 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 § 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 × 2 hour per 

investigation). All national accrediting 

organizations already require their 

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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 × 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 × 148 hours), and $64,615,320 

for all non-accredited HHAs ($46/hour × 

1,025,640 hours). 

TABLE 4—PATIENT RIGHTS

Standard Time per HHA 

(hours) 

Total time 

(hours) Cost per HHA Total cost 

Providing notice of rights (annual, non-accredited/accredited HHAs) ............. 124/93 1,324,320 $7,440/5,580 $79,459,200 

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 § 484.55) 

We propose to retain the requirements 

of current § 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 § 484.60) 

The current regulations at § 484.12(c), 

‘‘Compliance with accepted professional 

standards and principles’’; § 484.14(g), 

‘‘Coordination of patient services’’; and 

§ 484.18 ‘‘Acceptance of patients, plan 

of care, and medical supervision,’’ 

would be reorganized and revised at 

proposed § 484.60. 

The change in § 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 

§ 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 § 484.60(a), ‘‘Plan of care,’’ 

would codify current industry standards 

of practice through the revision of 

current § 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 

§ 484.55, ‘‘Comprehensive assessment of 

patients.’’ Therefore, this proposed 

requirement would not present a new 

burden. 

Proposed § 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 § 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 § 484.60(c), ‘‘Review and 

revision of the plan of care,’’ would 

incorporate some current requirements. 

Although there has been some revision 

to current § 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 § 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 § 484.60(d), ‘‘Coordination 

of care,’’ would revise current 

§ 484.14(g), ‘‘Coordination of patient 

services,’’ and some elements of current 

§ 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 

§ 484.65) 

The quality assessment and 

performance improvement (QAPI) 

requirement replaces the current 

quality-related requirements of § 484.16, 

‘‘Group of professional personnel,’’ and 

§ 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 qualityrelated standards, and those standards 

far exceed the current Medicare 

regulations. Indeed, the current qualityrelated standards established by the 

accrediting organizations would, we 

believe, even exceed those that we 

propose to require in this rule. Since 

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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 datadriven, 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 nonaccredited HHA. 

In phase one, we believe that an HHA 

would: 

Æ 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 problemprone areas; and track adverse patient 

events; 

Æ Develop and revise policies and 

procedures to ensure that data is 

consistently collected, documented, 

retrieved, and analyzed in an accurate 

manner; and 

Æ Educate HHA employees and 

contractors about the QAPI requirement, 

philosophy, policies, and procedures. 

In phase two, we believe that a HHA 

would: 

Æ Enter data into patient clinical 

records during patient assessments; 

Æ Aggregate data by collecting the 

same pieces of data from patient clinical 

records and other sources (for example, 

human resource records); 

Æ 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 

Æ 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: 

Æ Identify new domains and 

measures that may replace or be in 

addition to the domains and measures 

already being monitored by the HHA; 

Æ Develop and/or revise policies and 

procedures to accommodate the new 

domains and measures; and 

Æ 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 × 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 × 6,930 nonaccredited 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 agencyspecific 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, Medicarecertified HHAs had 242,020 clinician 

FTEs, for an average of 24 clinical FTEs 

per HHA. The cost per HHA is $1,824 

× (1 hour per clinical staff member × 24 

clinical staff members × $76 per hour 

per clinical staff member). The total 

hour for non-accredited HHAs is 

166,320 (24 hours per average HHA × 

6,930 non-accredited HHAs) and the 

total cost is $12,640,320 (166,320 hours 

× $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, 

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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 × 12 months × 

$26/hour) per HHA. The total cost is 

$8,648,640 ($1,248 per HHA × 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 § 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 × $63/hour for 

QAPI coordinator + 1 hour × $98/hour 

for administrator + 1 hour × $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 × 6,930 

HHAs) in year 2 and thereafter. 

TABLE 5—QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT

Standard Time per HHA 

(hours) 

Total time 

(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 § 484.70) 

There is no specific current 

requirement addressing infection 

control in the current HHA CoPs. 

However, current § 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 welldocumented 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 

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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 × 

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 × $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

Standard Time per HHA 

(hours) 

Total time 

(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 

§ 484.75) 

We would consolidate current 

provisions located at § 484.30, ‘‘Skilled 

nursing services’’; § 484.32, ‘‘Therapy 

services’’; and § 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 

§ 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 

§ 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 

§ 484.100) 

The current regulations at § 484.12(a), 

‘‘Compliance with Federal, State, and 

local laws and regulations’’; § 484.12(b), 

‘‘Disclosure of ownership and 

management information’’; and 

§ 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 § 484.105) 

Several of the requirements currently 

found at § 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 

§ 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 § 484.14(e), 

‘‘Personnel policies,’’ § 484.14(g), 

‘‘Coordination of patient services,’’ and 

§ 484.14(j), ‘‘Laboratory services,’’ 

would be reorganized with minor 

revisions under proposed § 484.60(d), 

‘‘Coordination of care,’’ § 484.100(c), 

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61200 Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Proposed Rules 

‘‘Laboratory services,’’ and § 484.105(c), 

‘‘Clinical manager,’’ respectively. 

In order to facilitate compliance with 

§ 484.60(d) and to ensure that each 

patient’s care is coordinated, we 

propose to combine, revise, and 

elaborate on current § 484.14(d) and (e) 

at proposed § 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 § 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, multidisciplinary 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 § 484.110) 

The current regulation at § 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 

§ 484.115) 

We would reorganize the personnel 

qualification requirements currently 

found at § 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 § 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 § 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 currentlyapproved 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 § 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 × 4 meetings per year), for a 

total of 190,880 hours (16 hours per 

HHA × 11,930 HHAs) at cost of 

$19,422,040 ($1,628 per HHA × 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 § 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 

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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] 

Category Estimates 

Units 

Year dollar Discount rate 

(%) 

Period 

covered 

Costs: 

Annualized Monetized ($million/year) ....................................................... 138 

138 

2014 

2014 

7 

3 

2015–2019 

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 Medicarecertified HHAs with average annual 

patient census of 1,488 patients per 

HHA. An average Medicareparticipating 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 perHHA basis is minimal (approximately a 

$20,500 net increase in burden per nonaccredited 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 

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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 

■ 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 

■ 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 

■ 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 

■ 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). 

■ 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 

§ 409.43 ...................... (a) ................................................................ § 484.18(a) ................................................... § 484.60(a). 

§ 409.43 ...................... (c)(1)(i)(C) .................................................... 42 CFR 484.4 .............................................. 42 CFR 484.115. 

§ 409.43 ...................... (d) ................................................................ § 484.4 ......................................................... § 484.115. 

§ 409.44 ...................... (b)(1) introductory text and (c)(2)(ii) ............ § 484.4 ......................................................... § 484.115. 

§ 409.45 ...................... (c)(4) ............................................................ § 484.4 ......................................................... § 484.115. 

§ 409.46 ...................... (b) ................................................................ § 484.36(d) ................................................... § 484.80(h). 

§ 409.47 ...................... (b) ................................................................ § 484.14(h) ................................................... § 484.105(e). 

§ 410.62 ...................... (a) introductory text ..................................... § 484.4 ......................................................... § 484.115. 

§ 418.76 ...................... (f)(1) ............................................................. § 484.36(a) and § 484.36(b) ........................ § 484.80. 

§ 418.76 ...................... (f)(2) ............................................................. § 484.36(a) ................................................... § 484.80(a). 

§ 440.110 .................... (a)(2) and (b)(2) ........................................... § 484.4 ......................................................... § 484.115 of this chapter. 

PART 484—HOME HEALTH SERVICES 

■ 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. 

■ 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. 

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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 

§ 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. 

§ 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 

§ 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. 

§ 484.45 Condition of participation: 

Reporting OASIS information. 

HHAs must electronically report all 

OASIS data collected in accordance 

with § 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. 

§ 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, 

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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 Statefunded, 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 

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(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. 

§ 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, speechlanguage 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. 

§ 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 

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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. 

§ 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 

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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. 

§ 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). 

§ 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 § 409.44 of this chapter, and 

physician and medical social work 

services as specified in § 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 § 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 § 484.115(j). 

(2) Rehabilitative therapy services are 

provided under the supervision of an 

occupational therapist or physical 

therapist that meets the requirements of 

§ 484.115(e) or (g), respectively. 

(3) Medical social services are 

provided under the supervision of a 

social worker that meets the 

requirements of § 484.115(l). 

§ 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 §§ 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 § 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 

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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 

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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 selfadministered. 

(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 speechlanguage 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 speechlanguage 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 

§ 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 

§ 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 §§ 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 §§ 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 

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in accordance with the applicable 

requirements of part 493 of this chapter. 

§ 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 § 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 predesignated 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 speechlanguage pathology services must meet 

all of the applicable conditions of this 

part and the additional health and safety 

requirements set forth in §§ 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 

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(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. 

§ 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 § 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. 

§ 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 SpeechLanguage-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 § 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 

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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; 

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(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 § 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 speechlanguage 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 speechlanguage 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 

■ 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 

■ 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. 

■ 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 

§ 485.58 .............. Introductory text ............................................ 484.4 ............................................................. 484.115. 

§ 485.70 .............. (c) and (e) ..................................................... § 484.4 ........................................................... § 484.115. 

§ 488.805 ............ Definition of ‘‘temporary management’’ ........ §§ 484.4 and 484.14(c) ................................. §§ 484.105(b) and 484.115. 

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 

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