CMS-10539 Supporting Statement - Updated 07-09-15

Supporting Statement for the Paperwork Reduction Act Submission,
Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies

A. Background
The purpose of this package is to request Office of Management and Budget (OMB) approval of
the collection of information requirements for the proposed conditions of participation (CoPs) that
home health agencies (HHAs) would be required to meet to participate in the Medicare program.
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) (42 U.S.C. 1395x). These
services must be furnished by, or under arrangement with, an HHA that participates in the
Medicare program, and be provided on a visiting basis in the beneficiary's home. They may
include the following:
•
•
•
•
•
•
•

Part-time or intermittent skilled nursing care furnished by or under the supervision of a
registered nurse.
Physical therapy, speech-language pathology, or 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 (SNFs), or rehabilitation centers when they
involve equipment too cumbersome to bring to the home.

Section 1861(o) of the Act (42 U.S.C. 1395x) specifies certain requirements that a home health
agency must meet to participate in the Medicare program. (Existing regulations at 42 CFR
440.70(d) specify that HHAs participating in the Medicaid program must also meet the Medicare
CoPs.) In particular, section 1861(o)(6) of the Act requires that an HHA must meet the CoPs
specified in section 1891(a) of the Act and such other CoPs as the Secretary finds necessary in the
interest of the health and safety of its 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.
Under the authority of sections 1861(o), 1871 and 1891 of the Act, the Secretary proposes to
establish in regulations the requirements that an HHA must meet to participate in the Medicare
program. These requirements would be set forth in 42 CFR Part 484 as Conditions of
Participation for Home Health Agencies. The CoPs apply to an HHA as an entity as well as the
services furnished to each individual under the care of the HHA, unless a condition is specifically
limited to Medicare beneficiaries.
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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 generally conduct surveys of HHAs to determine whether they are
complying with the CoPs.
B. Justification
1.

Need and Legal Basis

The information collection requirements for which we are requesting OMB approval are listed
below. These requirements are among other requirements classified as (or known as) the CoPs
which are based on criteria prescribed in law and are standards designed to ensure that each HHA
safely and effectively delivers care to all patients. The information collection requirements
described herein are needed to implement the Medicare CoPs for Medicare- and Medicaidparticipating HHAs. We believe many of the requirements applied to these HHAs would impose
no burden since a prudent institution would self-impose them in the course of doing business.
Additionally, these particular standards reflect comparable standards developed by industry
organizations such as The Joint Commission and the Community Health Accreditation Program.
Section 1861(o) of the Act (42 U.S.C. 1395x) specifies certain requirements that an HHA must
meet to participate in the Medicare program. (Existing regulations at 42 CFR 440.70(d) specify
that HHAs participating in the Medicaid program must also meet the Medicare CoPs.) In
particular, section 1861(o)(6) of the Act requires that an HHA must meet the CoPs specified in
section 1891(a) of the Act and such other CoPs as the Secretary finds necessary in the interest of
the health and safety of its 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.
Under the authority of sections 1861(o), 1871 and 1891 of the Act, the Secretary proposes to
establish in regulations the requirements that an HHA must meet to participate in the Medicare
program.
2.

Information Users

The primary users of this information will be State agency surveyors, the regional home health
intermediaries, CMS, and HHAs for the purpose of ensuring compliance with Medicare CoPs as
well as ensuring the quality of care provided to HHA patients.
3.

Use of Information Technology

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HHAs may use various information technologies to store and manage records as long as they are
consistent with the existing confidentiality in record-keeping regulations at 42 CFR 485.638. This
regulation in no way prescribes how the HHA should prepare or maintain these records. HHAs are
free to take advantage of any technological advances that they find appropriate for their needs.
4.

Duplication of Efforts

There is no duplication of information.
5.

Small Business Impact

This information collection affects small businesses. However, the requirements are sufficiently
flexible for providers to meet them in a way consistent with their existing operations.
6.

Less Frequent Collection

CMS does not collect information directly from home health agencies on a scheduled basis.
Rather, HHAs are expected to maintain their own records in a timely fashion. With less frequent
collection, CMS would not be able to ensure compliance with HHA CoPs.
7.

Special Circumstances Leading to Information Collection

There are no special circumstances for collecting this information.
8.

Federal Register Notice/Outside Consultation

The 60-day Federal Register notice published on April 24, 2015. This information collection request is
associated with Home Health Agency Conditions of Participation (0938-AG81) which published
October 9, 2014.
9.

Payments or Gift to Respondents

There are no payments or gifts to respondents.
10. Confidentiality
We do not pledge confidentiality of aggregate data. We pledge confidentiality of patient-specific
data in accordance with the Privacy Act of 1974 (5 U.S.C. 552a).
11. Sensitive Questions
There are no questions of a sensitive nature associated with this information collection.

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12. Burden Estimates (Hours and Wages)
The information collection requirements are shown below with an estimate of the annual reporting
and record keeping burdens. Included in the estimates is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information.
Assumptions and Estimates Used Throughout
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
Number of HHA patients in Medicare-participating, accredited
HHAs

17,751,840
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 HHA office employee*

$26

Hourly rate of administrator*

$98

Hourly rate of QAPI coordinator**

$63

*Estimate from the Bureau of Labor Statistics Occupational Outlook Handbook, 2014-2015
edition; includes 100 percent benefits and overhead package.
**Based on a registered nurse fulfilling this role.
§484.45 Reporting OASIS Information
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, 09380760.
§484.50 Patient Rights

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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 to which home
health patients are entitled, 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. We would require the
following:
•

•
•
•
•
•
•
•

An 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.
An HHA must document the existence and resolution of complaints about the care
furnished by the HHA that were made by the patient, representative, and family.
An HHA must advise the patient in advance of the disciplines that will furnish care, the
plan of care, expected outcomes, factors that could affect treatment, and any changes in the
care to be furnished.
An HHA must advise the patient of the HHA's policies and procedures regarding the
disclosure of patient records.
An HHA must advise the patient of his or her liability for payment.
An HHA must advise the patient of the number, purpose, and hours of operation of the
state home health hotline.
An HHA must advise the patient of the names, addresses, and telephone numbers of
pertinent State and local consumer information, consumer protection, and advocacy
agencies.
An HHA must advise the patient of 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) of this section. A copy of the signed notice would serve as documentation of
compliance. We estimate that an HHA will utilize an administrator to develop the patient rights
form. All newly established HHAs would need to develop a notice of patient rights document. In
order to speed up the process of becoming Medicare-approved, the majority of new HHAs are
choosing to become accredited by a national accrediting organization for Medicare deeming
purposes. The patient rights standards and patient notification requirements of the national
accrediting organizations would meet or exceed those proposed in this rule; therefore this rule
would not impose a burden upon those new HHAs that choose to obtain accreditation status for
Medicare deeming purposes. We estimate that it would take 8 hours for each new non-accredited
HHA 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
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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, an 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 recordkeeping standards; therefore accredited HHAs would not be burdened by this new standard. The
total annual burden per non-accredited HHA (6,930) would be 6 hours (74 investigations x 5
minutes per investigation / 60).
We believe that the requirements of proposed standard (f), “Accessibility,” related to providing
information to patients in a manner that can be understood would not impose a burden because
HHAs are already required to comply with these requirements in accordance with Title VI of the
Civil Rights Act of 1964, the Americans With Disabilities Act, and Section 504 of the
Rehabilitation Act. HHAs should already be in compliance with these longstanding requirements.
§484.55 Comprehensive Assessment of Patients
Proposed §484.55 would require the HHA to conduct, document and update, within a defined
timeframe, a patient-specific comprehensive assessment that identifies the patient’s need for HHA
care and services, and the patient’s need for physical, psychosocial, emotional and spiritual care.
While these requirements are subject to the PRA, the associated burden imposed by these
requirements is considered to be usual and customary medical practice as defined in 5 CFR 1320.3
(b) (2). All health care providers, regardless of their type of service, location, or other factors,
routinely assess patients to determine their current status and care needs in keeping with the basic
tenets of medical care as well as discipline-specific licensure requirements.
§484.60 Care Planning, Coordination of Services, and Quality of Care
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
requirement consists of longstanding requirements that implement statutory provisions found in
§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. This requirement would not impose a burden for those 292 Medicare
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patients per HHA. The anticipated burden associated with this requirement involves a member of
the office support staff who would facilitate interaction with the physician. We estimate that this
would take 5 minutes per admission for a total estimated burden of 100 hours per HHA ([1196
non-Medicare admits per year x 5 minutes] / 60 minutes per hour).
Proposed §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 who 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 an 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.
§484.65 Quality Assessment and Performance Improvement (QAPI)
Proposed §484.65 would require HHAs to develop, implement, maintain and evaluate an effective,
data-driven quality assessment and performance improvement program. We have not prescribed
the structures and methods for implementing this requirement and have focused the condition
toward the expected results of the program. This provides flexibility to the HHA, as it is free to
develop a creative program that meets the HHA’s needs and reflects the scope of its services.
The first standard under §484.65 requires that an HHA’s quality assessment and performance
improvement program 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 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,
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implementation, maintenance, and evaluation of the quality assessment and performance
improvement program, as described in §484.65, will impose a 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 industrywide total of 27,720 hours. (4 hours per HHA x 6,930 non-accredited HHAs), and an industrywide cost of $1,746,360 (27,720 hours x $63/hour).
Although there are other QAPI requirements, they do not relate to record keeping.
§484.70 Infection Prevention and Control
Proposed §484.70 would require an 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 care-acquired infections
have been a source of significant research, education, and training efforts by both the public and
private health care sectors for more than a decade, maintaining documents and disclosing
information pertaining to infection control is generally regarded as a usual and customary business
practice in the HHA community.
§484.75 Skilled Professional Services
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,
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thereby exempting the associated burden as stated in 5 CFR 1320.3(b)(3).
§484.80 Home Health Aide Services
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.
All home health aide services must be provided by individuals who meet the personnel
requirements and training criteria as specified. An HHA is required to maintain documentation
that each home health aide meets these qualifications as specified in 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 HHA 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/assets/1/7/10HC_Stats.pdf ).
Based on an estimate of 5 minutes per newly hired aide and two newly hired aides per agency, per
year, we estimate that there will be 1,988 annual burden hours ([5 minutes per aide x 2 aides per
HHA] / 60 minutes per hour x 11,930 HHAs) for the home health industry. We assume that an
office employee ($26/hour) would perform this function at a cost of $4 per HHA per year. The
total cost for all HHAs is $51,688 (1,988 hours x $26/hour).
Proposed §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 x 2 aides per
HHA] / 60 minutes per hour x 11,930 HHAs). The cost burden associated with this requirement is
$51,688, based on an office employee completing the documentation ($26/hour x 1,988 hours).
Proposed §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
9

the information and maintain the documentation as part of the HHAs records. We estimate that it
would take each of the 11,930 HHAs 5 minutes per newly hired aide per year to document that the
requirements of this standard have been met. The estimated annual burden is 1,988 hours ([5
minutes per aide x 2 aides per HHA] / 60 minutes per hour x 11,930 HHAs). The cost burden
associated with this requirement is $51,688, based on an office worker completing the
documentation ($26/hour x 1,988 hours).
Proposed §484.80(d) states that an HHA would be required to maintain documentation that all
home health aides have received at least 12 hours of in-service training during each 12-month
period. The burden associated with this requirement would be the time and effort necessary to
document and maintain records of the required in-service training. We assume that it would
require 5 minutes per aide to document the in-service training, and that these trainings would be
conducted on a quarterly basis, for a total of 2 hours per HHA, annually, to meet this requirement
([5 minutes per aide per training x 4 trainings per year x 6 aides] / 60 minutes per hour). The
estimate total annual burden for this requirement is 23,860 hours (2 hours per HHA x 11,930
HHAs).
Proposed §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.
At §484.80(h) we propose that HHAs would be required 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).
§484.100 Compliance with Federal, State, and Local Laws and Regulations Related to the
Health and Safety of Patients
At 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. It
would impose a minimal burden of adding the necessary additional information to the current
10

disclosure used by HHAs. 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).
§484.105 Organization and Administration of Services
We proposed to require that the HHA must organize, manage, and administer its resources to
attain and maintain the highest practicable functional capacity for each patient regarding medical,
nursing, and rehabilitative needs as indicated by the plan of care. Although there are reporting and
documentation requirements associated with the 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 1½ 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).
§484.110 Clinical Records
This section would require that clinical records contain pertinent past and current findings, and
that they would be maintained for every patient who is accepted by the HHA for 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
11

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 an 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 an 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, an HHA 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.
§484.115 Personnel Qualifications
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.
Burden and Cost Estimates Associated with Information Collection Requirements

12

Regulation
Section
*§484.50(a)
*§484.50(a)
§484.50(e)
§484.60(a)
*§484.65(e)
§484.80(a)
§484.80(b)
§484.80(c)
§484.80(d)
§484.100(a)
*§484.100(a)
§484.105(h)
§484.105(h)
§484.110(a)
Total

Respondents
65
11,930
6,930
11,930
6,930
11,930
11,930
11,930
11,930
11,930
549
6,930
65
11,930
19,474

Responses
65
11,930
512,820
14,268,280
6,930
23,860
23,860
23,860
286,320
11,930
549
6,930
65
17,751,840
32,929,239

Burden
per
Response
(in hours)
8
1
0.083
0.083
4
0.083
0.083
0.083
0.083
0.083
1
0.5
1.5
0.083

Total
Annual
Burden
(in hours)
520*
11,930*
42,735
1,189,023
27,720*
1,988
1,988
1,988
23,860
994
549*
3,465
98
1,479,320
2,786,178

Hourly
Labor Cost
of Reporting
($)
98
98
63
26
63
26
26
26
26
98
98
98
98
26

Total Cost
of
Reporting
($)
50,960
1,169,140
2,692,305
36,914,598
1,746,360
51,688
51,688
51,688
620,360
97,412
53,802
339,570
9,604
38,462,320
82,311,495

Total
Costs ($)
50,960
1,169,140
2,692,305
36,914,598
1,746,360
51,688
51,688
51,688
620,360
97,412
53,802
339,570
9,604
38,462,320
82,311,495

*Denotes a one-time information collection requirement.
Total burden hours requested = 2,786,178 hours.
13. Capital Costs
There are no capital costs associated with this information collection.
14. Cost to Federal Government
There are minimal costs associated with these requirements that are accrued at the Federal level
and especially at the regional office (RO) levels. For example, RO staff is responsible for acting
on the information collections requirements discussed in this package as it relates to home health
agency compliance. Once state survey agencies have completed their surveys and if a final
decision to terminate a home health agency for noncompliance is to be made, such decisions are
made by the Central Office and the RO.
15. Changes to Burden
This is a new information collection.
16. Publication and Tabulation Dates
There are no publication or tabulation dates.
17. Expiration Date
This collection does not lend itself to the displaying of an expiration date.

13