§484.50 Condition of participation: Patient rights.

Interpretive Guidelines §484.50

Ensuring that patients (and representative, if any) are aware of their rights and how to exercise them is vital to quality of care and patient satisfaction. HHAs must inform patients of their rights and protect and promote the exercise of these rights, e.g., by informing the patient how to exercise those rights.

The manner and degree of noncompliance identified in relation to the standard level tags for §484.50 may result in substantial noncompliance with this CoP, requiring citation at the condition level.

Survey Procedures: §484.50

When there is a team surveying the HHA, survey of the Patient rights Condition should be coordinated by one surveyor. However, each surveyor, as they conduct their survey assignments, should assess the HHA’s compliance with the Patient rights regulatory requirements. It is particularly important for the surveyor who will be conducting home visits to observe how the HHA’s actions protect and promote those patients’ exercise of their rights.

• Determine whether the HHA provides patients (or their representatives, if any), with notice of their rights, consistent with the standards under this condition. Review documents in the home provided by the HHA to the patient if the patient (or authorized representative) can provide them.

• Determine whether the HHA promotes the patients’ exercise of their rights (or their representatives, as applicable), consistent with the standards under this condition. Interview the patient (or authorized representative) to assess whether they were informed that they are entitled to certain rights.

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.

Interpretive Guidelines §484.50(a)(1)(i)

We expect HHA patients to be able to confirm, upon interview, that their rights and responsibilities, as well as the transfer and discharge policies of the HHA, were understandable and accessible.

To ensure patients receive appropriate notification:

• Written notice to the patient or their representative of their rights and responsibilities under this rule should be provided via hard copy unless the patient requests that the document be provided electronically.

• If a patient or his/her representative’s understanding of English is inadequate for the patient’s comprehension of his/her rights and responsibilities, the information must be provided in a language or format familiar to the patient or his/her representative.

• Language assistance should be provided using competent bilingual staff, staff interpreters, contracts or formal arrangements with local organizations providing interpretation, translation services, or technology and telephonic interpretation services.

• All agency staff should be trained to identify patients with any language barriers which may prevent effective communication of the rights and responsibilities. Staff that have on-going contact with patients who have language barriers, should be trained in effective communication techniques, including the effective use of an interpreter.

See §484.50(f) for discussion on communication of rights and responsibilities with patients who have disabilities that may hinder communication with the HHA.

Interpretive Guidelines §484.50(a)(1)(iii)

Use of the OASIS Privacy Notice is required under the Federal Privacy Act of 1974 and must be used in addition to other notices that may be required by other privacy laws and regulations. The OASIS privacy notice is available in English and Spanish on the CMS website. The OASIS Privacy Notice must be provided at the time of the initial evaluation visit.

Survey Procedures: §484.50(a)(1)(iii)

Patient interview and clinical record review should confirm that the required privacy notice was provided.

Survey Procedures: §484.50(a)(2)

Clinical record review should confirm that the required written notice of patient rights and responsibilities was provided to the patient. Note if the patient/legal representative’s signature was obtained as required.

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.

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.

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 verbal, mental, sexual, or physical and includes abuse facilitated or enabled through the use of technology.

“Verbal abuse” refers to abuse perpetrated through any use of insulting, demeaning, disrespectful, oral, written or gestured language directed toward and in the presence of the client.

“Mental abuse” is a type of abuse that includes, but is not limited to, humiliation, harassment, and threats of punishment or deprivation, sexual coercion and intimidation (e.g. living in fear in one’s own home).

“Sexual abuse” is a type of abuse that includes any incident where a beneficiary is coerced, manipulated, or forced to participate in any form of sexual activity for which the beneficiary did not give affirmative permission (or gave affirmative permission without the mental capacity required to give permission), or sexual assault against a beneficiary who is unable to defend him/herself.

“Physical abuse” refers to abuse perpetrated through any action intended to cause physical harm or pain, trauma or bodily harm (e.g., hitting, slapping, punching, kicking, pinching, etc.). It includes the use of corporal punishment as well as the use of any restrictive, intrusive procedure to control inappropriate behavior for purposes of punishment.

“Injury of unknown” source is an injury that was not witnessed by any person and the source of the injury cannot be explained by the patient.

“Misappropriation of property” is theft or stealing of items from a patient’s home. The HHA staff must investigate and take immediate action on any allegations of misappropriation of patient property by HHA staff and refer to authorities when appropriate.

Neglect means a failure to provide goods and/or services necessary to avoid physical harm, mental anguish or mental illness.

Survey Procedures: §484.50(c)(2)

Examine the extent to which the HHA has a system in place to protect patients from abuse, neglect, and misappropriation of property of all forms, whether from staff or from other persons. Determine the extent to which the HHA addresses the following issues:

• How does the HHA staff conduct themselves in the patient’s home in regards to demonstrating respect for persons and property?

• Does the HHA have policies and procedures for investigating allegations of abuse, neglect and misappropriation of property?

• Interview staff to determine if staff members know what to do if they witness abuse, neglect or misappropriation of property.

• Ask the HHA if it has had any allegations of patient abuse or neglect from any source during the past year. If it has, ask the HHA to provide the files and to describe how the matter was handled. Review the HHA records to see if the appropriate agencies were notified in accordance with State and federal laws regarding incidents of substantiated abuse and neglect.

Interpretive Guidelines §484.50(c)(3)

The HHA should have written policies and procedures that address the acceptance, processing, review, and resolution of patient complaints, including complaint intake procedures, timeframes for investigations, documentation, and potential outcomes and 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.

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 take 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 way 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.

Survey Procedures: §484.50(c)(5)

Clinical record review and patient interview should confirm that the HHA is providing the services identified in the patient’s individualized plan of care (see also §484.60(a)).

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, and Breach Notification Rules, as applicable, including consulting appropriate counsel as necessary.

Survey procedures §484.50(c)(6)

Verify that the agency staff maintain the confidentiality of protected health information that they transport and use.

Survey Procedures §484.50(c)(7)

Ask the patient or legal representative (if any) about whether the HHA informed them if there were any services that may not be covered by Medicare and, if so, how that would be addressed. If a notice of Medicare non-coverage was provided to the patient, confirm that it was received prior to the care being provided. Surveyors are not to advise the patient about finances, or coverage, or payment issues, but rather confirm if the HHA provided this information.

Interpretive Guidelines §484.50(c)(8)

§405.1200 through §405.1204 describe the expedited determination process, which is a right that Medicare beneficiaries may exercise to dispute the termination of Medicare-covered services in certain settings including home health.

Survey Procedures §484.50(c)(8)

Surveyors are not to advise the patient about finances, or coverage, or payment issues, but rather confirm if the HHA provided this information.

Survey Procedures §484.50(c)(9)

Determine if the patient is aware of the state home health hotline to lodge a complaint if dissatisfied with the care provided by the HHA. Inquire if the patient filed any complaints directly with the HHA and if the care and services were negatively affected by this action (see also §484.50(c)(11)).

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 after 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 after receipt by the HHA of a patient complaint, without a medical justification for the change of services or discharge.

Survey Procedures §484.50(c)(11)

Inquire if the patient filed any complaints directly with the HHA and if the care and services were negatively affected by this action. Determine if the patient is aware of the state HHA hotline to lodge a complaint if dissatisfied with the care provided by the HHA (§484.50(c)(9)).

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 or allowed practitioner 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. (As noted in §484.2, “allowed practitioner” means a physician assistant, nurse practitioner, or clinical nurse specialist as defined at this part.) 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 the discharge planning requirements at §484.58 and the requirements at §484.110(a)(6)(ii) regarding time frame for the transfer summary.

Interpretive Guidelines §484.50(d)(4)

A patient who occasionally declines a service is distinguished from a patient who refuses services altogether, or who habitually declines skilled care visits. It is the patient’s right to refuse services. It is the agency’s responsibility to educate the patient on the risks and potential adverse outcomes that can result from refusing services. In the case of patient refusals of skilled care, the HHA must document its communication with the physician or allowed practitioner who is responsible for the patient’s home health plan of care, as well as the measures the HHA took to investigate the patient’s refusal and the interventions the HHA attempted in order to obtain patient participation with the plan of care.

The HHA may consider discharge if the patient’s decision to decline services compromises the agency’s ability to safely and effectively deliver care to the extent that the agency can no longer meet the patient’s needs.

Interpretive Guidelines §484.50(d)(5)

“Disruptive, abusive behavior” includes verbal, non-verbal or physical threats, sexual harassment, or any incident in which agency staff feel threatened or unsafe, resulting in a serious impediment to the agency’s ability to operate safely and effectively in the delivery of care.

“Uncooperative” is defined as the patient’s repeated declination of services or persistent obstructive, hostile or contrary attitudes to agency caregivers that are counterproductive to the plan of care.

The HHA must document in the patient’s clinical record the behaviors and circumstances that warranted patient discharge for cause as well as the HHA’s efforts to resolve the problems.

Interpretive Guidelines §484.50(d)(5)(i)

The HHA must notify the patient, his or her representative (if any), the physician(s) or allowed practitioners(s) 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 can 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.

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.

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.

Survey Procedures §484.50(e)(1)(ii)

Obtain the complaint log (or other format used for documenting complaints) to verify that the HHA is tracking complaints received from receipt of complaint through resolution.

Interpretive Guidelines §484.50(e)(1)

The HHA should have systems in place to record, track and investigate all complaints. Written policies and procedures on the acceptance, processing, review, and resolution of patient complaints should be developed and communicated to staff. These policies should include intake procedures, timeframes for investigations, documentation, and outcomes and actions that the HHA may take to resolve patient complaints. Complaint investigations should be incorporated into the agency’s Quality Assurance Performance Improvement program.

The HHA should be able to produce documentation for each complaint received that confirms that an investigation was conducted and records the investigation findings as well as the ultimate resolution of the complaint. The documentation should also describe any actions taken by the HHA to remove any risks to the patient while the complaint was being investigated.

Interpretive Guidelines §484.50(e)(2)

Immediately means reporting without delay, as soon as possible following the discovery. States commonly have mandatory reporting requirements for providers, suppliers, and individuals making them legally responsible to report suspicions of abuse and neglect to appropriate State authorities. These entities and individuals should follow existing mandatory reporting requirements in their State in addition to any applicable Federal requirements. Action or inaction on the part of a provider or supplier to follow mandatory reporting requirements does not preclude an employee from fulfilling their reporting obligations.

Interpretive Guidelines §484.50(f)

“Plain language” (also referred to as “Plain English”) is communication the patient and/or his or her representative (if any) can understand the first time they read or hear it. Language that is plain to one set of readers may not be plain to others. Written material is in plain language if the audience can:

• Find what they need; • Understand what they find; and • Use what they find to meet their needs.

Section 504 of the Rehabilitation Act and the Americans with Disabilities Act protect qualified individuals with disabilities from discrimination on the basis of disability in the provision of benefits and services. Concerns related to potential discrimination issues under 504 should be referred to the Office of Civil Rights for further review.

“Auxiliary aids and services” for individuals who are deaf or hard of hearing include services and devices such as, but not limited to: qualified interpreter services (on-site or through video remote interpreting (VRI)); note takers; real-time computer-aided transcription services; written materials; exchange of written notes; telephone handset amplifiers; assistive listening devices; assistive listening systems; telephones compatible with hearing aids; closed caption decoders; open and closed captioning, including real-time captioning; voice, text, and video-based telecommunications products and systems, including text telephones (TTYs), videophones, and captioned telephones, or equally effective telecommunications devices; videotext displays; and accessible electronic and information technology. Auxiliary aids and services for individuals who are blind or have low vision include services and devices such as: qualified readers; taped texts; audio recordings; Braille materials and displays; screen reader software; magnification software; optical readers; secondary auditory programs (SAP); large print materials; and accessible electronic and information technology.

The patient’s clinical record should include evidence that the HHA facilitated the availability of needed auxiliary aids and language services.