CMS SOM App. H, Tag V451

§ 494.70 - The dialysis facility must inform patients (or their representatives) of their rights

(including their privacy rights) and responsibilities when they begin their treatment and

must protect and provide for the exercise of those rights.

Interpretive Guidance § 494.70

When they being their treatment at the facility, patients (or their representatives) must be

notified of the rights that protect them, as well as the responsibilities that are expected of them.

To promote patient safety and strengthen the relationship between a patient (and/or their

representative) and their care team, patients should be provided with this information when they

begin their treatments. Information that is provided should be understood and reciprocated. The

patient’s readiness and ability to fully comprehend this information may be impacted by reasons

such as stress and anxiety that some new patients may experience when starting dialysis. For

these situations, the facility should determine an appropriate point in time at the beginning of

their treatment to inform them of their rights and responsibilities. Typically, information should

be provided to the patient and/or their family or caregiver(s) within the first (6) dialysis

treatments. By this time, patients have generally overcome any initial stress and anxieties related

to dialysis initiation.

Informing patients could include providing verbal explanations, audiovisual presentations,

and/or written materials. Documentation should confirm that the required information is

provided to patients.

Patient representative: The HIPAA Privacy Rule establishes a foundation of Federally-protected rights which permit individuals to control certain uses and disclosures of their

protected health information. Along with these rights, the Privacy Rule provides individuals with

the ability to access and amend this information, and the right to an accounting of certain

disclosures. There may be times when individuals are legally or otherwise incapable of

exercising their rights, or simply choose to designate another to act on their behalf with respect

to these rights. Under the Privacy Rule, a person authorized (under State or other applicable

law, e.g., tribal or military law) to act on behalf of the individual in making health care related

decisions is the individual’s “personal representative.” Subject to certain exceptions, the

Privacy Rule at 45 CFR 164.502(g) requires covered entities to treat an individual’s personal

representative as the individual with respect to uses and disclosures of the individual’s protected

health information, as well as the individual’s rights under the Rule. \

All states define an age of majority. Most states have set their age of majority in statute. It varies

between 21 and 18 years of age; in most states in the United States, the age of majority is 18

years old. Persons younger than this age of majority are considered minors, and are under the

care of a parent or guardian unless they are emancipated. For the pediatric dialysis population,

the parent or guardian of a minor is considered to be a “designee” for that child. However,

older youths with decision-making capacity may be included in decision-making with the

parent’s consent.

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For more information on personal representatives and who must be recognized as the

individual’s personal representative, please see OCR guidance for "Personal Representatives".