Editorial Note on Part 460
Editorial Note: Nomenclature changes to part 460 appear at 67 FR 61504, Oct. 1, 2002.

§ 460.82 Marketing. ( a ) *Information that a PACE organization must include in its marketing materials.* ( 1 ) A PACE organization must inform the public about its program and give prospective participants the following written information: ( i ) An adequate description of the PACE organization's enrollment and disenrollment policies and requirements.
( ii ) PACE enrollment procedures.
( iii ) Description of benefits and services.
( iv ) Premiums.
( v ) Other information necessary for prospective participants to make an informed decision about enrollment.
( 2 ) Marketing information must be free of material inaccuracies, misleading information, or misrepresentations.
( b ) *Approval of marketing information.* ( 1 ) CMS must approve all marketing information before distribution by the PACE organization, including any revised or updated material.
( 2 ) CMS reviews initial marketing information as part of an entity's application for approval as a PACE organization, and approval of the application includes approval of marketing information.
( 3 ) Once a PACE organization is under a PACE program agreement, any revisions to existing marketing information and new information are subject to the following: ( i ) *Time period for approval.* CMS approves or disapproves marketing information within 45 days after CMS receives the information from the organization.
( ii ) *Deemed approval.* Marketing information is deemed approved, and the organization can distribute it, if CMS and the State administering agency do not disapprove the marketing material within the 45-day review period.
( c ) *Special language requirements.* A PACE organization must furnish printed marketing materials to prospective and current participants as specified below: ( 1 ) In English and in any other principal languages of the community, as determined by the State in which the PACE organization is located. In the absence of a State standard, a principal language of the community is any language that is spoken in the home by at least 5 percent of the individuals in the PACE organization's service area.
( 2 ) In Braille, if necessary.
( d ) *Information on restriction of services.* ( 1 ) Marketing materials must inform a potential participant that he or she must receive all needed health care, including primary care and specialist physician services (other than emergency services), from the PACE organization or from an entity authorized by the PACE organization.
( 2 ) All marketing materials must state clearly that PACE participants may be fully and personally liable for the costs of unauthorized or out-of-PACE program agreement services.
( e ) *Prohibited marketing practices.* A PACE organization must not use the following marketing practices, which are prohibited: ( 1 ) Discrimination of any kind, except that marketing may be directed to individuals eligible for PACE by reason of their age.
( 2 ) Activities that could mislead or confuse potential participants, or misrepresent the PACE organization, CMS, or the State administering agency.
( 3 ) Gifts or payments to induce enrollment, unless the gifts are of nominal value as defined in CMS guidance, are offered to all potential enrollees without regard to whether they enroll in the PACE program, and are not in the form of cash or other monetary rebates.
( 4 ) Marketing by any individual or entity that is directly or indirectly compensated by the PACE organization based on activities or outcomes unless the individual or entity has been appropriately trained on PACE program requirements, including but not limited to, subparts G and I of this part. ( i ) PACE organizations are responsible for the activities of contracted individuals or entities who market on their behalf.
( ii ) PACE organizations that choose to use contracted individuals or entities for marketing purposes must develop a method to document training has been provided.
( 5 ) Unsolicited door-to-door marketing or other unsolicited means of direct contact, including calling or emailing a potential or current participant without the individual initiating the contact.
[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25674, June 3, 2019]