A. Background
The purpose of this package is to request Office of Management and Budget (OMB) approval of the revision of collection of information requirements for the conditions of participation (CoPs) that home health agencies (HHAs) are required to meet to participate in the Medicare program (OMB control number 0938-1299).
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.
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.
On September 30, 2019, CMS published a final rule Medicare and Medicaid Programs;
Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (51836 FR Vol. 84 No. 189). This rule added a new Discharge Planning CoP at §484. 58. This new CoP requires HHA’s develop and implement an effective discharge planning process. The revision to requirements and burden hours are outlined below.
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 Medicaid-participating 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
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
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.
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.
Number of Medicare-participating HHAs nationwide |
11,744 |
Number of Medicare-participating HHAs that are accredited |
4,388 |
Number of HHA patients in Medicare- participating HHAs nationwide |
17,751,840 |
Number of HHA patients in Medicare-participating, accredited HHAs |
6,634,656 |
Number of Medicare beneficiaries in HHAs |
3,333,965 |
Average number of new HHAs per year |
388 |
Average number of new, non-accredited HHAs per year |
36 |
Average number of patients per HHA per year |
1,512 |
Hourly rate of HHA office employee* |
$38 |
Hourly rate of administrator* |
$98 |
Hourly rate of QAPI coordinator** |
$70 |
*Estimate from the Bureau of Labor Statistics, Healthcare Occupations, September 2020; includes 100 percent benefits and overhead package.
**Based on a registered nurse fulfilling this role.
§484.45 Reporting OASIS Information
Section 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 internet Quality Improvement & Evaluation
System (iQIES) System, 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 iQIESSystem or the CMS OASIS contractor. While this requirement is subject to the PRA, the burden is currently approved under the following OMB control number, 0938-1279.
§484.50 Patient Rights
Section §484.50 implements the patient rights provisions of section 1891(a)(1) of the Act. The purpose is to recognize certain rights to which home health patients are entitled, and protect their rights. HHAs are required to inform each patient of their rights. In §484.50, we require HHAs to inform patients about the expected outcomes of treatment and the factors that could affect treatment. The HHAs are asked to devote efforts to improve patient’s health literacy, which lead to an increased comprehension of diagnosis and treatment for both patients and family. Increased comprehension allows patients to remain active and make the best possible decisions for their medical care. We require the following:
An HHA must provide the patient and representative (legal or patient-selected) with an oral and a written notice of the patient’s rights in a manner that the individual can understand. The HHA must also document that it has complied with the requirements of this section.
An HHA must document the existence and resolution of complaints about the care furnished by the HHA that were made by the patient, representative, and family.
An HHA must advise the patient in advance of the disciplines that will furnish care, the plan of care, expected outcomes, factors that could affect treatment, and any changes in the care to be furnished.
An HHA must advise the patient of the HHA's policies and procedures regarding the disclosure of patient records.
An HHA must advise the patient of his or her liability for payment.
An HHA must advise the patient of the number, purpose, and hours of operation of the state home health hotline.
An HHA must advise the patient of the names, addresses, and telephone numbers of specified State-funded and federally funded entities.
An HHA must advise the patient of the right to access auxiliary aids and language services, and how to access these services.
We believe that HHAs have developed a standard notice of rights to fulfill the requirements contained in §484.50(a) of this section. A copy of the signed notice serves 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 288 hours (8 hours per HHA x 36 HHAs). The estimated cost associated with this requirement is $784 per HHA and $28,224 for all new non-accredited HHAs, annually. .
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 (76) 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 (7,356) would be 6 hours per HHA(76 investigations x .08333). The total annual cost for all HHA’s $3,089,520 (46,136 hours x $70)
We believe that the requirements of standard (f), “Accessibility,” related to providing information to patients in a manner that can be understood would not impose a burden because all HHAs have already attested to CMS that they are in compliance with the requirements of Title VI of the Civil Rights Act of 1964, the Americans With Disabilities Act, and section 504 of the Rehabilitation Act. Since HHAs have already attested that they are in compliance with these longstanding requirements, and since the requirements of this rule are not intended to go beyond these statutes, no new burden would be imposed.
§484.55 Comprehensive Assessment of Patients
Section 484.55 requires the HHA to conduct, document and update, within a defined timeframe, a patient-specific comprehensive assessment that identifies the patient’s need for HHA care and services, and the patient’s need for physical, psychosocial, and emotional care. The information collection burden associated with the OASIS data set, which comprises the core of the patient assessment, is currently approved under OMB control number 0938-1279. The current expiration date is December 31, 2021
§484.58 Discharge Planning
On September 30, 2019, CMS published a final rule Medicare and Medicaid Programs;
Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (51836 FR Vol. 84 No. 189). This rule added a new Discharge Planning CoP at §484. 58. This new CoP requires HHA’s develop and implement an effective discharge planning process. Specifically, at § 484.58(b), Discharge or transfer summary content, we require that the HHA send necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care.
In addition, we are also including a requirement at § 484.58(b)(2) for HHAs to comply with requests for additional information as may be necessary for treatment of the patient made by the receiving facility or health care practitioner. To meet both the requirements to assist patients in selecting follow-up post-acute care providers and to develop a discharge or transfer summary for each patient, we estimate that it will take an HHA approximately 10 minutes (0.167 hours) per patient. Thus, for the 11,744 HHAs, we estimate that complying with this requirement will require 2,964,557 burden hours ( 17,751,840 patients × 0.167 hours) at an approximate cost of $207,518,990 million (2,964,557 burden hours × $70 average hourly salary for a registered nurse (RN)).
§484.60 Care Planning, Coordination of Services, and Quality of Care
Section 484.60 requires that each patient’s written plan of care specify the care and services necessary to meet the patient-specific needs identified in the comprehensive assessment. Additionally, the written plan of care is 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. Additionally the plan of care must also specify the patient and caregiver education and training specific to the patient’s care needs. We believe compliance with certain plan of care requirements, such as addressing each patient’s psychosocial status and interventions to address readmission risk factors, will impose a burden of 10 minutes per patient, per plan of care. A typical HHA patient will have one plan of care. We believe that most HHAs are already addressing these areas during the care planning process as they are usual and customary practices in delivering high quality care. For purposes of this analysis only, we assume that 90 percent of HHAs are already complying with these requirements, and that 10 percent will need to comply. We estimate that the 1,174 HHAs that are not already addressing these new factors in their care planning process will use 296,440 hours (1,512 patients per HHA x 0.167 hours per patient x 1,174 HHAs) at a cost of $20,750,800 for a nurse to document the new required information in the plan of care.
Section 484.60(a) requires that each patient’s written plan of care be established and periodically reviewed by a physician or allowed practitioner. While HHAs average 1,512 home health patient admissions per year, 302 of those are Medicare patients. Having a doctor or allowed practitioner 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 requirement. This requirement would not impose a burden for those 302 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 or allowed practitioner. We estimate that this would take 5 minutes per admission for a total estimated burden of 101 hours per HHA ([1,210 non-Medicare admits per year x .0833). The total burden hours for all HHA’s 1,186,144 (101 x 11,744) with the total annual cost for all HHA’s $45,073,472 (1,186,144 x $38).
Section 484.60(a)(4) and (b)(1) require HHAs to conform and fulfill all medical orders issued in writing or telephone (and later authenticated) by a patient’s physician or allowed practitioner. We believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3 (b) (2). Issuing orders for patient care is one of the most fundamental tasks performed by physicians or allowed practitioners. Likewise, documenting and adhering to physician or allowed practitioners orders is one of the most fundamental tasks performed by the physician, allowed practitioners 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.
Section
484.60(c) requires an HHA to review, revise and document the plan on
a timely basis. The
burden associated with these requirements is the time and effort
associated with reviewing, revising, and maintaining the plan of
care. For purposes of this analysis only, we assume that 90% of all
existing HHA’s are already providing these updates and 10% of
HHA’s are not. There are an average of 1,512 patient per HHA.
We believe compliance with maintaining the plan of care will impose a
burden of 5 minutes per patient, per updated plan of care. Assuming
that a typical HHA patient will have one update to the plan of care,
we estimate that all HHAs will use 147,332 hours (1,512 patients per
HHA x 0.083 hours per patient x 1,174 HHAs). With a total cost or
$10,313,240 for a nurse to document the required information in the
plan of care (147,322 x $70).
Section 484.60(e) requires the HHA to provide written instructions to the patient and care giver outlining visit schedule including frequency of visits, medication schedule/instructions, treatments administered by HHA personnel and personnel acting on the behalf of the HHA, pertinent instructions related to patient care, and the name and contact information of the HHA clinical manager. Giving written instruction to the patient and care giver outlining the medication schedule/instructions, visit schedule, pertinent instruction related to the patient’s care and treatments and contact information of the HHA has been a long standing practice in the home health industry and is one of the most fundamental elements in patient education. For purposes of this analysis only, we assume that 90 percent of HHAs are already providing this information and 10 percent are not. We estimate that it would take 20 minutes to provide a patient with this written information and that each patient will receive written information twice while under the HHA’s care. Based on these assumptions, we estimate that this provision will impose 1,183,274 hours of burden for all HHA’s to provide this education twice per patient at a cost of $ 82,829,180 for a nurse to provide the written information (1,512 x .3333 hours per patient x 1,174 HHA’s x $70).
§484.65 Quality Assessment and Performance Improvement (QAPI)
Section 484.65 requires HHAs to develop, implement, maintain and evaluate an effective, data-driven quality assessment and performance improvement program. We have not prescribed the structures and methods for implementing this requirement and have focused the condition toward the expected results of the program. This provides flexibility to the HHA, as it is free to develop a creative program that meets the HHA’s needs and reflects the scope of its services.
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 conduct performance improvement projects that reflect the scope, complexity, and past performance of the HHA’s services and operations, and document these projects.
We believe the updating 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 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 updating 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 updating the internal policies would be an average of 1 hours annually per HHA, for an industry-wide total of 7,356 hours. (1 hours per HHA x 7,356 non-accredited HHAs), and an industry-wide cost of $514,920 ( 7,356 hours x $70/hour).
HHAs accredited by the Joint Commission, the Community Health Accreditation Partner, and the Accreditation Commission for Health Care are already required by their accrediting bodies to undertake and document performance improvement projects. In the absence of accreditation requirements, we believe that most HHAs already document the quality projects that they have undertaken as part of standard business practice. For purposes of this analysis only, we assume that 10 percent of non-accredited HHAs would use additional resources to document their quality projects. We estimate that the affected HHAs would use 1 hour per quarter to document performance improvement project activities and that the QAPI coordinator would perform this function, for a total of 2,942 hours (0.1 x 7,356 non-accredited HHAs x 1 hour per quarter x 4 quarters per year) at a cost of $205,940 (2,942 hours X $70) .
§484.70 Infection Prevention and Control
Section 484.70 requires an HHA to maintain and document an infection control program with the goal of preventing and controlling infections and communicable diseases. Specifically, §484.70(b) states that the HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s QAPI program. Section 484.70(c) also requires that each HHA provide infection control education to staff, patients, and caregivers. Since health care-acquired infections have been a source of significant research, education, and training efforts by both the public and private health care sectors for more than a decade, we believe that all HHAs already have infection prevention and control programs. The burden associated with the infection prevention and control program would be the time necessary to document the program. We estimate that each HHA will spend 1 hour per quarter documenting its infection prevention and control program, for a total of 46,976 hours (11,744 HHAs x 1 hour per quarter x 4 quarters) at a cost of $3,288,320 (46,976 x $70) for a nurse to complete the documentation.
§484.75 Skilled Professional Services
Section 484.75 requires skilled professionals who provide services to HHA patients as employees or under arrangement to participate in all aspects of care. This includes, but is not limited to, participation in the on-going patient assessment process; development and maintenance of the interdisciplinary plan of care; patient, caregiver, and family counseling; patient and caregiver education; and communication with other health care providers. Section 484.75 also requires skilled professionals to be actively involved in the HHA's QAPI program and participate in HHA in-service trainings. Furthermore, §484.75 requires 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. Therefore, the burden associated with the requirement is not subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). In addition, the aforementioned requirements would in all likelihood exist in the absence of federal regulations.
§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 §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 37 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. The literature shows that the aide turnover rate in 2019 has significantly increased to 36.5%. However, the average number of aides employed per HHA remains at 6 with 2 additional hires per year.
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 1,957 annual burden hours .1667 x 11,744 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 $74,366 (1,957 hours x $38/hour).
Section 484.80(b)(1) through (3) discuss the content and duration of the home health aide classroom and supervised practical training. With respect to the recordkeeping requirements, §484.80(b)(4) states that an HHA is required to maintain documentation that demonstrates that the requirements of this standard have been met. The burden associated with this requirement would be the time and effort necessary to document the information and maintain the documentation as part of the HHAs records. We estimate that it would take each of the 11,744 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 1,957 hours ([.1667 hour x 11,744 HHAs). The cost burden associated with this requirement is $74,366, based on an office employee completing the documentation ($38/hour x 1,957 hours).
Section 484.80(c) contains the standard for competency evaluation. An individual could furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. With respect to the recordkeeping requirements, §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 is 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 11,744 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 1,957 hours ([.1667 hour x 11,744 HHAs). The cost burden associated with this requirement is $74,366, based on an office employee completing the documentation ($38/hour x 1,957 hours).
Section 484.80(d) states that an HHA is required to maintain documentation that all home health aides have received at least 12 hours of in-service training during each 12-month period. The burden associated with this requirement is the time and effort necessary to document and maintain records of the required in-service training. We assume that it would require 5 minutes per aide to document the in-service training, and that these trainings would be conducted on a quarterly basis, for a total of approximately 2 hours per HHA, annually, to meet this requirement (0.0833 hours per aide per training x 4 trainings per year x 6 aides] = 2 hours per HHA and 23,488 hours for all HHA’s (2 x 11,744) The estimated total cost for all HHA’s is is $892, 544 ( 23,488 hours x x $38).
Section 484.80(g) states that a registered nurse or other appropriate skilled professional must prepare written patient care instructions for a home health aide. The burden associated with this requirement is the time and effort necessary for a registered nurse or other skilled professional to draft written patient care instructions for a home health aide. Providing written patient care instructions is a usual and customary business practice in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Home health aide licensure standards require aides to practice under the direction of a nurse or other qualified medical professional. Likewise, the scope of practice for nurses and other qualified medical professionals includes the preparation of patient care instructions.
At §484.80(h) we require that HHAs document the supervision of home health aides in accordance with specified timeframes. Supervising employees to ensure the safe and effective provision of patient care is standard business practice throughout the health care community. Likewise, documenting that this supervision has occurred for internal personnel, accreditation, and state and federal compliance purposes constitutes a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulation of the PRA at 5 CFR 1320.3(b)(2).
§484.100 Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients
At §484.100(a), the HHA is required to disclose to the state survey agency, at the time of the HHA’s initial request for certification, the name and address of all persons with an ownership or control interest in the HHA, the name and address of all officers, directors, agents, and managers of the HHA. This also includes 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. we estimate that it would require new HHAs 1 hour to develop a disclosure statement, for a total of 388 annual hours industry wide each year (1 hour per new HHA x 388 new HHAs) for a total of $38,024 for all HHA’s (388 x $98).
§484.105 Organization and Administration of Services
We 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 do not impose a burden on HHAs. For example, §484.105(d)(1) states that the parent HHA is responsible for reporting all branch locations of the HHA to the state survey agency at the time of the HHA’s request for initial certification, at each survey, and at the time the parent proposes to add or delete a branch. Similarly, §484.105(e)(2) states that an HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA’s patients. We believe the burden associated with the aforementioned will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Paragraph (h) of this section, Institutional Planning, imposes a minimal burden of the time required by new HHAs to develop the initial plan and by existing HHAs to review and revise the existing plan. We estimate the burden for developing a new plan at 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 3,678 hours (7,356 existing non-accredited HHAs x 30 minutes] / 60 minutes per hour) for a total of $360,444. The estimated annual burden for anticipated new HHAs is 54 hours (1.5 hours per HHA x 36 new HHAs) at a cost of $5,292 (54 hours X $98).
§484.110 Clinical Records
This section requires that clinical records contain pertinent past and current findings, and that they be maintained for every patient who is accepted by the HHA for home health services. All entries in the clinical record are authenticated, dated and timed, which is usual and customary clinical practice and does not impose a burden. Clinical records must be retained for 5 years after the month the cost report for the records is filed with the intermediary. HHAs are required to have written procedures that govern the use and removal of records, and the conditions for release of information. This section contains longstanding provisions that are specifically required in section 1861(o) of the Act, and are necessary to preserve the patient’s privacy and the quality of care. The aforementioned documentation and record retention requirements are considered usual and customary business practices; therefore the burden associated with those requirements will not be subject to the PRA in accordance with the implementing regulation of the PRA at 5 CFR 1320.3(b)(2).
At §484.110(a)(5) HHAs are required to send a copy of a patient’s discharge or transfer summary to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA, or the facility, if the patient leaves HHA care to enter a facility for further treatment. We estimate that an HHA would spend 5 minutes per patient sending the discharge or transfer summary to the patient’s next source of health care services, for a total of 1,479,152 hours for all HHAs annually (.0833 x 1,512 patients] x 11,744 HHAs) = at a cost of $56,207,776 for an office employee to send the required documentation ($38 per hour x 1,479,152 hours).
Furthermore, an HHA must make available a patient’s clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). The burden associated with this requirement is the time and effort required to disclose a clinical record to an appropriate authority. Making clinical records available to the appropriate authority is part of the survey and certification process, and we believe compliance with this requirement will constitute a usual and customary business practice. Therefore, the burden associated with this requirement will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Furthermore, we do not believe that this requirement would alter the frequency or scope of requests stemming from other appropriate authorities such as law enforcement.
§484.115 Personnel Qualifications
In §484.115, we defer to state certification or state licensure requirements in cases where personnel requirements are not statutory or do not relate to a specific payment provision. As defined in the implementing regulations of the PRA at 5 CFR 1320.3(b)(2), these requirements are usual and customary business practices. In accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(3), we believe this state requirement would exist even in the absence of the federal requirement; therefore, the associated burden is not subject to the PRA.
Regulation Section |
OMB Control No. |
Respondents |
Responses |
Burden per Response (in hours) |
Total Annual Burden (in hours) |
Hourly Labor Cost of Reporting ($) |
Total Cost of Reporting ($) |
Total Costs ($) |
§484.50(a) |
0938-1299 |
36 |
36 |
8 |
288 |
98 |
28,224 |
28,224 |
§484.50(e) |
0938-1299 |
7,356 |
559,056 |
0.083 |
46,136 |
70 |
3,089,520 |
3,089,520 |
§484.58(b)(2) |
0938-1299 |
11,744 |
17,751,840 |
0.167 |
2,964,557 |
70 |
207,518,990 |
207,518,990 |
§484.60(a) |
0938-1299 |
1,174
|
1,775,088
|
0.167 |
296,440 |
70 |
20,750,800 |
20,750,800
|
§484.60(a) |
0938-1299 |
11,744 |
14,210,240 |
0.083 |
1,186,144 |
38 |
45, 073,472
|
45, 073,472
|
§484.60(c) |
0938-1299 |
1,174 |
1,775,088
|
0.083 |
147,322
|
70 |
$10,313,240
|
$10,313,240
|
§484.60(e) |
0938-1299 |
1,174 |
3,550,176
|
0.333 |
1,183,274 |
70 |
8$82,829,180 |
$82,829,180
|
§484.65(e) |
0938-1299 |
7356 |
7,356 |
1 |
7,356
|
70 |
514,920 |
514,920
|
§484.65(d) |
0938-1299 |
736 |
2,942
|
1 |
2,942
|
70 |
205,940 |
205,940
|
§484.70 |
0938-1299 |
11,744 |
46,976
|
1 |
46,976
|
70 |
3,288,320
|
3,288,320
|
§484.80(a) |
0938-1299 |
11,744 |
23,488 |
0.083 |
1,957 |
38 |
74,366 |
74,366 |
§484.80(b) |
0938-1299 |
11,744 |
23,488 |
0.083 |
1,957 |
38 |
74,366 |
74,366 |
§484.80(c) |
0938-1299 |
11,744 |
23,488 |
0.083 |
1,957 |
38 |
74,366 |
74,366 |
§484.80(d) |
0938-1299 |
11,744 |
281,856 |
0.083 |
23,488 |
38 |
$892,544 |
$892,544 |
§484.100(a) |
0938-1299 |
388 |
388 |
1 |
388 |
98 |
38,024 |
38,024 |
|
|
|
|
|
|
|
|
|
§484.105(h) |
0938-1299 |
7,356 |
7,356 |
0.5 |
3,678
|
98 |
360,444
|
360,444 |
§484.105(h) |
0938-1299 |
36 |
36 |
1.5 |
54 |
98 |
5,292 |
5,292 |
§484.110(a) |
0938-1299 |
11,744 |
17,751,840 |
0.083 |
1,479,152
|
38 |
$56,207,776 |
$56,207,776 |
Total |
|
110,738 |
57,790,738 |
|
7,394,066 |
|
$386,266,312 |
$386,266,312
|
Total burden hours requested = 7,394,066 hours.
13. Capital Costs
There are no capital costs associated with this information collection because all documentation can be accomplished with equipment that is already owned by HHAs. Some HHAs may choose to upgrade their current equipment to operate more efficiently, but such upgrades are not necessary to meet these minimum standards.
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
While the number of Medicare participating HHA’s has slightly decreased over the last 3 years, the number of new HHA’s entering the program has almost doubled and the number of HHA patients in Medicare participating HHA’s has remained the same. There is one new burden added at 484.58 Discharge Planning. On September 30, 2019, CMS published a final rule Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (51836 FR Vol. 84 No. 189). This new CoP requires HHA’s develop and implement an effective discharge planning process. This new requirement added over $207 million to the overall burden. The burden hours inceased from 4,462,295 to 7,394,066 from the last approval. Also, the hourly rate of most of the HHA staff noted in this package has significantly increased from 2017.
16. Publication and Tabulation Dates
There are no publication or tabulation dates.
17. Expiration Date
CMS will publish a notice in the Federal Register to inform the public of both the approval and the expiration date. In addition, the public will be able to access the expiration date on OMB’s website by performing a search using the OMB control number.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement For Paperwork Reduction Act Submissions |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2021-01-22 |