[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR422.128]



[Page 1004-1005]

 

                         TITLE 42--PUBLIC HEALTH

 

                    CHAPTER IV--CENTERS FOR MEDICARE

                          & MEDICAID SERVICES,

                        DEPARTMENT OF HEALTH AND

                             HUMAN SERVICES

 

PART 422_MEDICARE ADVANTAGE PROGRAM--Table of Contents

 

             Subpart C_Benefits and Beneficiary Protections

 

Sec. 422.128  Information on advance directives.



    (a) Each MA organization must maintain written policies and 

procedures that meet the requirements for advance directives, as set 

forth in subpart I of part 489 of this chapter. For purposes of this 

part, advance directive has the meaning given the term in Sec. 489.100 

of this chapter.

    (b) An MA organization must maintain written policies and procedures 

concerning advance directives with respect to all adult individuals 

receiving medical care by or through the MA organization.

    (1) An MA organization must provide written information to those 

individuals with respect to the following:

    (i) Their rights under the law of the State in which the 

organization furnishes services (whether statutory or recognized by the 

courts of the State) to make decisions concerning their medical care, 

including the right to accept or refuse medical or surgical treatment 

and the right to formulate advance directives. Providers may contract 

with other entities to furnish this information but remain legally 

responsible for ensuring that the requirements of this section are met. 

The information must reflect changes in State law as soon as possible, 

but no later than 90 days after the effective date of the State law.

    (ii) The MA organization's written policies respecting the 

implementation of those rights, including a clear and precise statement 

of limitation if the MA organization cannot implement an advance 

directive as a matter of conscience. At a minimum, this statement must 

do the following:

    (A) Clarify any differences between institution-wide conscientious 

objections and those that may be raised by individual physicians.

    (B) Identify the state legal authority permitting such objection.

    (C) Describe the range of medical conditions or procedures affected 

by the conscience objection.

    (D) Provide the information specified in paragraph (a)(1) of this 

section to each enrollee at the time of initial enrollment. If an 

enrollee is incapacitated at the time of initial enrollment and is 

unable to receive information (due to the incapacitating condition or a 

mental disorder) or articulate whether or not he or she has executed an 

advance directive, the MA organization may give advance directive 

information to the enrollee's family or surrogate in the same manner 

that it issues other materials about policies and procedures to the 

family of the incapacitated enrollee or to a surrogate or other 

concerned persons in accordance with State law. The MA organization is 

not relieved of its obligation to provide this information to the 

enrollee once he or she is no longer incapacitated or unable to receive 

such information. Follow-up procedures must be in place to ensure that 

the information is given to the individual directly at the appropriate 

time.

    (E) Document in a prominent part of the individual's current medical 

record whether or not the individual has executed an advance directive.

    (F) Not condition the provision of care or otherwise discriminate 

against an individual based on whether or not the individual has 

executed an advance directive.

    (G) Ensure compliance with requirements of State law (whether 

statutory or recognized by the courts of the State) regarding advance 

directives.

    (H) Provide for education of staff concerning its policies and 

procedures on advance directives.

    (I) Provide for community education regarding advance directives 

that may include material required in paragraph (a)(1)(i) of this 

section, either directly or in concert with other providers or



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entities. Separate community education materials may be developed and 

used, at the discretion of the MA organization. The same written 

materials are not required for all settings, but the material should 

define what constitutes an advance directive, emphasizing that an 

advance directive is designed to enhance an incapacitated individual's 

control over medical treatment, and describe applicable State law 

concerning advance directives. An MA organization must be able to 

document its community education efforts.

    (2) The MA organization--

    (i) Is not required to provide care that conflicts with an advance 

directive; and

    (ii) Is not required to implement an advance directive if, as a 

matter of conscience, the MA organization cannot implement an advance 

directive and State law allows any health care provider or any agent of 

the provider to conscientiously object.

    (3) The MA organization must inform individuals that complaints 

concerning noncompliance with the advance directive requirements may be 

filed with the State survey and certification agency.