CMS Pub. 100-11, ch. 3, § 80

42 CFR 460.82(b)

CMS views the following as materials largely designed to get the consumer’s

attention and provide contact information for purposes of requesting more

information. POs must ensure that these materials meet applicable

requirements and should have a system to track, maintain these materials

so that they may be made available to CMS upon request.

These are not subject to CMS review and approval and should not be

submitted in HPMS:

• HIPAA Privacy notices (subject to enforcement by the Office for Civil

Rights within the U.S. Department of Health and Human Services

(DHHS));

• Press releases that do not include any PACE-specific information (e.g.,

information about benefits, premiums, co-pays, deductible, benefits,

how to enroll, networks, etc.);

• Advertising/Promotional Materials (see Appendix 1);

• Banner and Banner-Like ads (see Appendix 1);

• Outdoor Advertising (ODA) (see Appendix 1);

• Certain participant newsletters, unless sections are used to encourage

enrollment or disenrollment;

• Letterhead/fax coversheets that do not include promotional language;

• General health promotion materials that do not include any specific

PO-related information and are educational in nature (e.g., health

education and disease management materials);

• Materials to educate participants, family members/caregivers, and Ad-Hoc Participant Communications Materials (see Appendix 1) that are

not being distributed to prospective participants, or lack PACE-specific

information;

• Participant surveys; and

• Newsletters to professional referral sources to keep them up-to-date

on the PACE program.

• Materials that provide information to current participants, family

members, or caregivers, about their current enrollment in the PACE

program or provide non-PACE-specific health information.

• Items such as billboards, bus or bench ads, etc. that advertise the

PO’s name and provide contact information without providing more

detailed information.

Appendix 1 – Definitions

Ad-hoc Participant Communications Materials

Ad-hoc participant communications materials provide information that is

targeted to current participants or a customized/limited subset of

participants. They do not include information about the PO’s benefit

structure. They apply to specific situations, cover participant-specific

processes, or other operational issues. These materials are not marketing

materials.

Advertising/Promotional Materials

Advertising/promotional materials are primarily intended to attract or appeal

to a prospective participant. Advertising/promotional materials contain less

detail than other marketing materials, and may provide benefit information

at a level to entice a prospective participant to request additional

information.

Alternate Formats

Alternate formats are methods/forms of communication used to convey

information to participants with disabilities (e.g., Braille, large print, and

audio). These materials address reasonable accommodation requirements to

communicate marketing information.

Banner and Banner-Like Ads

Banner ads are typically in television ads and flash information quickly

across a screen with the sole purpose of enticing a prospective participant to

contact the PO to enroll or request more information. A “banner-like” ad is

usually in some media other than television (e.g., outdoor advertising and

internet banner ads), and is intended to be very brief and to entice someone

to call the PO or to alert someone that information is forthcoming. These

types of ads are considered informational and are not considered marketing

materials.

Enrollment Materials

Enrollment materials are used to convey information specific to enrollment

and disenrollment. Enrollment materials that are used prior to enrollment

are considered marketing materials (see Appendix 2).

Health Plan Management System (HPMS)

HPMS is a web-enabled information system that supports the

implementation and ongoing operations of POs. HPMS and its software

modules may be used by POs to enter, track, and maintain marketing

materials submitted to CMS for review and approval.

Marketing Materials

Marketing materials are information POs provide to the public about its

program. Marketing materials can be used to educate prospective

participants. These materials must be approved by CMS and the SAA.

Mobile Applications (Apps)

Mobile apps are programs that are typically downloaded and run on a mobile

device. Mobile apps differ from websites in that a website is accessed via a

device’s web browser.

Nominal Value

Nominal value is currently defined by CMS as being worth $15 or less, based

on the retail value of the item in question. Any promotional activity or item

(i.e., gift) offered by POs, including those that will be used to encourage

retention of participants, must be of nominal value.

Note: CMS sets the maximum, not the minimum, for nominal value.

Outdoor Advertising (ODA)

Outdoor advertising is outdoor marketing intended to capture the attention

of a passing audience (e.g., billboards, signs attached to transportation

vehicles), and to influence them to request more detailed information on the

product being advertised.

Programs of All-inclusive Care for the Elderly (PACE)

PACE is a managed care Medicare/Medicaid program authorized under

sections 1894, 1905(a), and 1934 of the Social Security Act and Chapter 42

of the Code of Federal Regulations, Part 460 (see Appendix 2).

PACE Program Agreement

A PACE program agreement is an agreement between a PO, CMS, and the

SAA for the operation of a PACE program. A PO may only operate in a state

in accordance with a PACE program agreement.

Template Material

A template material is any marketing material that includes placeholders for

variable data to be populated at a later time.

Website Address

A website address is an address that is typed into an internet browser, also

known as a Universal Resource Locator (URL).

Appendix 2 - Related Laws and Regulations

(Rev. 4, Issued: 08-30-13, Effective: 05-08-13, Implementation: 10-29-13)

Chapter 42 of the Code of Federal Regulations Part 460

The PACE regulations can be found at https://www.gpo.gov/fdsys/granule/CFR-

2009-title42-vol4/CFR-2009-title42-vol4-part460

Privacy and Confidentiality

Additional information on the HIPAA Privacy Rule and its use and disclosure

requirements can be found at http://www.hhs.gov/ocr/privacy/

Americans with Disabilities Act

Additional information on the Americans with Disabilities Act can be found at

http://www.ada.gov/

Sections 501 and 504 of the Rehabilitation Act

Additional information on sections 501 and 504 of the Rehabilitation Act can be

found at

http://www.dol.gov/oasam/regs/statutes/sec504.htm and

http://transition.fcc.gov/cgb/dro/504/disability_primer_1.html

HPMS, Connectivity Guide and User Instructional Guides

Additional information can be found at https://www.hpms.cms.gov

Section 508 of the Rehabilitation Act

(Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the

Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998)

All POs that choose to create and maintain an Internet website must ensure that

it is compliant with web-based technology and information standards for people

with disabilities as specified in section 508 of the Rehabilitation Act. For

additional information, please go to the following website address:

http://www.section508.gov

Note: These Federal requirements are extended to all POs through the

requirements for non-discrimination under Federal grants and programs

(29 USC §794).

PACE Enrollment and Disenrollment

Additional information on PACE Enrollment and Disenrollment can be found in

the PACE Manual at http://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-

Items/CMS019036.html

Sections 1894, 1905(a) and 1934 of the Social Security Act

Additional information on the PACE provisions in the Social Security Act can be

found at https://www.socialsecurity.gov/OP_Home/ssact/title18/1894.htm;

https://www.socialsecurity.gov/OP_Home/ssact/title19/1934.htm and

http://www.socialsecurity.gov/OP_Home/ssact/title19/1905.htm