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State Operations Manual
Appendix B - Guidance to Surveyors: Home Health
Agencies
(Rev. 200, 02-21-20)
Transmittals for Appendix B
Regulations and Interpretive Guidelines for Home Health Agencies
Subpart A--General Provisions
§484.1 Basis and scope
§484.2 Definitions
Subpart B--Patient Care
§484.40 Condition of participation: Release of patient identifiable OASIS information.
§484.45 Condition of participation: Reporting OASIS information (a) Standard: Encoding and transmitting OASIS data (b) Standard: Accuracy of encoded OASIS data (c) Standard: Transmittal of OASIS data (d) Standard: Data Format
§484.50 Condition of participation: Patient rights. (a) Standard: Notice of rights (b) Standard: Exercise of rights (c) Standard: Rights of the patient (d) Standard: Transfer and discharge (e) Standard: Investigation of complaints (f) Standard: Accessibility
§484.55 Condition of participation: Comprehensive assessment of patients. (a) Standard: Initial assessment visit (b) Standard: Completion of the comprehensive assessment (c) Standard: Content of the comprehensive assessment (d) Standard: Update of the comprehensive assessment
§484.58 Condition of participation: Discharge planning. (a) Standard: Discharge planning.
(b) Standard: Discharge or transfer summary content.
484.60 Condition of participation: Care planning, coordination of services, and quality of care. (a) Standard: Plan of care (b) Standard: Conformance with physician orders (c) Standard: Review and revision of the plan of care (d) Standard: Coordination of care (e) Standard: Written information to the patient
§484.65 Condition of participation: Quality assessment and performance improvement (QAPI). (a) Standard: Program scope (b) Standard: Program data (c) Standard: Program activities (d) Standard: Performance improvement projects (e) Standard: Executive responsibilities
§484.70 Condition of participation: Infection prevention and control. (a) Standard: Prevention (b) Standard: Control (c) Standard: Education
§484.75 Condition of participation: Skilled professional services. (a) Standard: Provision of services by skilled professionals (b) Standard: Responsibilities of skilled professionals
§484.80 Condition of participation: Home health aide services. (a) Standard: Home health aide qualifications (b) Standard: Content and duration of home health aide classroom and supervised practical training (c) Standard: Competency evaluation (d) Standard: In-service training (e) Standard: Qualifications for instructors conducting classroom and supervised practical training (f) Standard: Eligible training and competency evaluation organizations (g) Standard: Home health aide assignments and duties (h) Standard: Supervision of home health aides (i) Standard: Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit.
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. (a) Standard: Disclosure of ownership and management information
Regulations and Interpretive Guidelines for Home Health Agencies
Subpart A--General Provisions
(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)
§484.1 Basis and scope
§484.2 Definitions
Pseudo patient means a person trained to participate in a role-play situation, or a computer-based mannequin device. A pseudo-patient must be capable of responding to and interacting with the home health aide trainee, and must demonstrate the general characteristics of the primary patient population served by the HHA in key areas such as age, frailty, functional status, and cognitive status.
Simulation means a training and assessment technique that mimics the reality of the homecare environment, including environmental distractions and constraints that evoke or replicate substantial aspects of the real world in a fully interactive fashion, in order to teach and assess proficiency in performing skills, and to promote decision making and critical thinking.
Subpart B--Patient Care
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.40 Condition of participation: Release of patient identifiable OASIS information. The HHA and agent acting on behalf of the HHA in accordance with a written contract must ensure the confidentiality of all patient identifiable information contained in the clinical record, including OASIS data, and may not release patient identifiable OASIS information to the public.
Interpretive Guidelines §484.
An agent acting on behalf of the HHA is a person or organization, other than an employee of the agency that performs certain functions on behalf of, or provides certain services under contract or arrangement. HHAs often contract with specialized software vendors to submit OASIS data and are commonly referred to by the HHA as the Third- Party vendor.
HHAs and their agents must develop and implement policies and procedures to protect the security of all patient identifiable information contained in electronic format that they create, receive, maintain, and transmit. The agreements between the HHA and OASIS vendors must address policies and procedures to protect the security of such electronic records in order to:
- Ensure the confidentiality, integrity, and availability of all electronic records they create, receive, maintain, or transmit;
- Identify and protect against reasonably anticipated threats to the security or integrity of the electronic records;
- Protect against reasonably anticipated, impermissible uses or disclosures; and,
- Ensure compliance by their workforce
The HHA is ultimately responsible for compliance with these confidentiality requirements and is the responsible party if the agent does not meet the requirements. (See also §484.50(c)(6) Patient Rights)
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.45 Condition of participation: Reporting OASIS information. HHAs must electronically report all OASIS data collected in accordance with §484.55. Interpretive Guidelines §484. The OASIS data collection set must include the data elements listed in §484.55(c)(8) and be collected and updated per the requirements under §484.55(d).
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.45(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. Interpretive Guidelines §484.45(a)
“CMS system” means the national Quality Improvement Evaluation System, Assessment Submission and Processing (QIES ASAP) system.
“Encode” means to enter OASIS information into a computer.
“Transmit” means electronically send OASIS information, from the HHA directly to the CMS system.
§484.45(c)(2) Successfully transmit test data to the QIES ASAP System or CMS OASIS contractor.
Interpretive Guidelines §484.45(c)(2)
The purpose of making a test transmission to the QIES ASAP system or CMS OASIS contractor is to establish connectivity. Prior to the initial certification survey, HHAs must demonstrate connectivity to the OASIS QIES ASAP system by—
- Testing transmission of start of care or resumption of care OASIS data that passes CMS edit checks to the QIES ASAP System or CMS OASIS contractor; and
- Receiving validation reports back from the QIES ASAP system confirming successful transmission of the test data that is verified on-site during the survey.
NOTE: the process for establishing test connectivity is detailed in the QIES technical support and the OASIS Submission Users Guide.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.45(c)(3)Transmit data using electronic communications software that complies with the Federal Information Processing Standard (FIPS 140-2, issued May 25,
- from the HHA or the HHA contractor to the CMS collection site.
Interpretive Guidelines §484.45(c)(3)
HHAs may directly transmit OASIS data (to the national data repository) via jHAVEN (i.e., the Home Assessment Validation and Entry System, which is an application that allows providers to collect and maintain agency, patient and OASIS assessment data) or other software that conforms to the FIPS 140-2.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.45(c)(4)Transmit data that includes the CMS-assigned branch identification number, as applicable.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.45(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.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§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.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(a) Standard: Notice of rights. The HHA must-
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(a)(1) Provide the patient and the patient’s legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: Interpretive Guidelines §484.50(a)(1)
The term “in advance” is defined at §484.2. “In advance” means that HHA staff must complete the task prior to performing any hands-on care or any patient education.
A “legal representative” is an individual who has been legally designated or appointed as the patient’s health care decision maker. When there is no evidence that a patient has a legal representative, such as a guardianship, a power of attorney for health care decision- making, or a designated health care agent, the HHA must provide the information directly to the patient.
The initial evaluation visit is the initial assessment visit that is conducted to determine the immediate care and support needs of the patient.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(a)(1)(i) Written notice of the patient’s rights and responsibilities under this rule, and the HHA’s transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities;
Interpretive Guidelines §484.50(a)(1)(i)
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(a)(2) Obtain the patient’s or legal representative’s signature confirming that he or she has received a copy of the notice of rights and responsibilities.
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(Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20)
§484.50(a)(3)
[Removed and reserved, see 84 FR 51732, at 51825 (Sept. 30, 2019)]
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(a)(4) Provide written notice of the patient’s rights and responsibilities under this rule and the HHA’s transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(b) Standard: Exercise of rights.
§484.50(b)(1) If a patient has been adjudged to lack legal capacity to make health care decisions as established by state law by a court of proper jurisdiction, the rights of the patient may be exercised by the person appointed by the state court to act on the patient’s behalf.
§484.50(b)(2) If a state court has not adjudged a patient to lack legal capacity to make health care decisions as defined by state law, the patient’s representative may exercise the patient’s rights.
§484.50(b)(3) If a patient has been adjudged to lack legal capacity to make health care decisions under state law by a court of proper jurisdiction, the patient may exercise his or her rights to the extent allowed by court order.
Interpretive Guidelines §484.50(b) The HHA should obtain official documentation of: (1) any adjudication by a court that indicates that a patient lacks the legal capacity to make his or her own health care decisions; and (2) the name of any person identified by the court who may exercise the patient’s rights.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(c) Standard: Rights of the patient. The patient has the right to—
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50 (c)(1)Have his or her property and person treated with respect; Interpretive Guidelines §484.50(c)(1)
Respect for Property: The patient has the right to expect the HHA staff will respect his or her property and person while in the patient’s home. The HHA must ensure that during home visits the patient’s property, both inside and outside the home, is not stolen, damaged, or misplaced by HHA staff.
Respect for Person: The HHA must consider and accommodate any patient requests within the parameters of the assessment and plan of care, and the patient must be treated by the HHA as an active partner in the delivery of care. The HHA should make all reasonable attempts to respect the preferences of the patient regarding the services that will be delivered, such as the HHA visit schedule, which should be made at the convenience of the patient rather than of the agency personnel. The HHA must keep the patient informed of the visit schedule and timely and promptly notify the patient when scheduled services are changed.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property;
Interpretive Guidelines §484.50(c)(2)
The patient has a right to be free from abuse from the HHA staff and others in his or her home environment. The HHA should address any allegations or evidence of patient abuse to determine if immediate care is needed, a change in the plan of care is indicated, or if a referral to an appropriate agency is warranted. (State laws vary in the reporting requirements of abuse. HHAs should be knowledgeable of these laws and comply with the reporting requirements.) In addition, the HHA should intervene immediately if, as indicated by the circumstances, any injury is the result of an HHA staff member’s actions. The HHA should also immediately remove staff from patient care if there are allegations of misconduct related to abuse or misappropriation of property.
“Abuse” means the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish. Abuse may be
actions that the HHA may take to resolve patient complaints. See also §484.50(e) Investigation of complaints.
The HHA should record, in both the clinical record and the patient’s home folder, that the patient was provided with information regarding his or her right to lodge a complaint to the HHA.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(c)(4) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to –
(i) Completion of all assessments;
(ii) The care to be furnished, based on the comprehensive assessment;
(iii) Establishing and revising the plan of care;
(iv) The disciplines that will furnish the care;
(v) The frequency of visits;
(vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits;
(vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished.
Interpretive Guidelines §484.50(c)(4)
The patient’s informed consent on the items (i)-(viii) is not intended to be recorded on a single signed form. Informed consent and patient participation takes place on an ongoing basis as the patient’s care changes and evolves during his or her episodes of care. There must be evidence in the patient’s medical record that, both initially and as changes occur in the patient’s care, the patient was consulted and consented to planned services and care.
“Participation” means that the patient is given options regarding care choices and preferences. For example, patient preferences should be respected in encouraging the patient to choose between a bath and a shower, unless there are physical restrictions or medical contraindications that limit patient choice. “Informed” means that all aspects of the planned care and services, and the manner in which the care and services will be delivered, are reviewed by HHA staff with the patient and that, during such review, HHA staff solicits the patient’s agreement or disagreement.
When there is a change to the plan of care, whether initiated by the HHA/physician or at the request of the patient, documentation in the clinical record should indicate whether the patient was informed of and agreed to the changes.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(c)(5) Receive all services outlined in the plan of care.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(c)(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.
Interpretive Guidelines §484.50(c)(6)
45 CFR Part 160 and 164 pertain to requirements of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The HIPAA Privacy Rule (45 CFR Part 160 and Subparts A and E of Part 164), Security Rule (45 CFR Part 160 and Subparts A and C of Part 164), and Breach Notification Rule (45 CFR §§ 164.400–414) protect the privacy and security of health information and provide individuals with certain rights regarding their health information as follows:
- The Privacy Rule sets national standards for covered entities (health plans, health care clearinghouses, and health care providers that conduct certain health care transactions electronically) and their business associates, including appropriate safeguards to protect the privacy of protected health information (PHI) and the limits and conditions under which PHI is permitted or required to be used or disclosed;
- The Security Rule specifies safeguards that covered entities and their business associates must implement to protect the confidentiality, integrity, and availability of electronic protected health information (ePHI)
- The Breach Notification Rule requires covered entities and their business associates to notify affected individuals, U.S. Department of Health & Human Services (HHS), and in some cases, the media of a breach of unsecured PHI. The HIPAA Privacy Rule also gives certain patients’ rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections.
HHAs have unique concerns and risks regarding staff and contractors who transport documents and/or electronic devices containing PHI, such as during their visits to patient’s homes. Compliance with §484.50(c)(6) is evidenced by documentation of HIPAA training for all staff and monitoring HIPAA compliance to manage the risk of inappropriate PHI disclosure or unsecured ePHI. Each covered entity and business associate is responsible for ensuring its compliance with the HIPAA Privacy, Security,
§484.50(c)(10) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides:
(i) Agency on Aging
(ii) Center for Independent Living
(iii) Protection and Advocacy Agency,
(iv) Aging and Disability Resource Center; and
(v) Quality Improvement Organization.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(c)(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.
Interpretive Guidelines §484.50(c)(11)
“Discrimination or reprisal against a patient for exercising his or her rights or for voicing grievances” is defined as treating a patient differently from other patients subsequent to receipt by the HHA of a patient complaint, without a medical justification for such different treatment.
Examples of discrimination or reprisal include, but are not limited to, a reduction of current services, a complete discontinuation of services, or discharge from the HHA subsequent to receipt by the HHA of a patient complaint, without a medical justification for the change of services or discharge.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(c)(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.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d) Standard: Transfer and discharge.
The patient and representative (if any), have a right to be informed of the HHA’s policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if:
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(1) The transfer or discharge is necessary for the patient’s welfare because the HHA and the physician who is responsible for the home health plan of care agree that the HHA can no longer meet the patient’s needs, based on the patient’s acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA’s capabilities;
Interpretive Guidelines §484.50(d)(1) When a patient’s care needs change to require more than intermittent services or require specialized services not provided by the agency, the HHA must inform the patient, patient representative (if any), and the physician who is responsible for the patient’s home health plan of care that the HHA cannot meet the patient’s needs without potentially adverse outcomes. The HHA should assist the patient and his or her representative (if any) in choosing an alternative entity by identifying those entities in the patient’s geographic area that may be able to meet the patient’s needs based on the patient’s acuity. Once the patient chooses an alternate entity, the HHA must contact that entity to facilitate a safe transfer. The HHA must ensure timely transfer of patient information to the alternate entity to facilitate continuity of care, i.e., the HHA must ensure that patient information is provided to the alternate entity prior to or simultaneously with the initiation of patient services at the new entity.
Also see §484.110(a)(6)(ii) regarding time frame requirement for the transfer summary.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(2) The patient or payer will no longer pay for the services provided by the HHA;
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(3) The transfer or discharge is appropriate because the physician who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician who is responsible for the home health plan of care agree that the patient no longer needs the HHA’s services;
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(5)(i) Advise the patient, representative (if any), the physician(s) issuing orders for the home health plan of care, and the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered;
Interpretive Guidelines §484.50(d)(5)(i) The HHA must notify the patient, his or her representative (if any), the physician issuing orders for the home health care and the patient’s primary care practitioner that the HHA is considering a discharge for cause. If the HHA is able to identify other health care professionals who may be involved in the patient’s care after the discharge occurs, then the HHA should notify those individuals of the discharge when discharge becomes imminent.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(5)(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;
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(5)(iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and
Interpretive Guidelines §484.50(d)(5)(ii) and (iii)
The clinical record should reflect:
- Identification of the problems encountered;
- Assessment of the situation;
- Communication among HHA management, patient caregiver, legal representative and the physician responsible for the plan of care;;
- A plan to resolve the issues; and
- Results of the plan implementation.
Only in extreme situations when there is a serious imminent threat of physical harm to HHA staff, the HHA may take immediate action to discharge or transfer the patient without first making efforts to resolve the underlying issue.
Evidence in the record should document that the HHA provided the patient and his or her representative (if any) with information including contact numbers for other community
resources and names of other agencies or providers that may be able to provide services to the patient.
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(5)(iv) Document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records;
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(6) The patient dies; or
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(d)(7) The HHA ceases to operate.
Interpretive Guidelines §484.50(d)(7)
The agency must provide sufficient notice of its planned cessation of business to enable patients to select an alternative service provider and to enable the HHA to facilitate the safe transfer of its patients to other agencies.
§484.50(e) Standard: Investigation of complaints. (Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
§484.50(e)(1) The HHA must—
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
(i) Investigate complaints made by a patient, the patient’s representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics:
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(Rev. 182, Issued: 09-28-18, Effective: 09-28-18, Implementation: 09-28-18)
(i)(A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; and
