54208 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 422 and 423 

[CMS 4131–F] 

RIN 0938–AP24 

Medicare Program; Medicare 

Advantage and Prescription Drug 

Benefit Programs: Final Marketing 

Provisions 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

Medicare Advantage (MA) program (Part 

C) and Medicare Prescription Drug 

Benefit Program (Part D). The regulation 

contains new regulatory provisions 

regarding marketing processes for both 

programs. The revisions to the Part C 

and Part D programs are based on 

lessons we have learned since 2006, the 

initial year of the prescription drug 

program and the revised MA program. 

DATES: Effective Date: The provisions of 

this regulation are effective September 

18, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Chevell Thomas, 410–786–1387. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Overview of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 

The Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Pub. L. 108–173) was 

enacted on December 8, 2003. The 

MMA established the Medicare 

Prescription Drug Benefit Program (Part 

D) and made revisions to the provisions 

in Medicare Part C, governing what is 

now called the Medicare Advantage 

(MA) program (formerly 

Medicare+Choice). The MMA directed 

that important aspects of the new 

Medicare Prescription Drug Benefit 

Program under Part D be similar to and 

coordinated with regulations for the MA 

program. 

The MMA also directed 

implementation of the prescription drug 

benefit program and revised MA 

program provisions by January 1, 2006. 

The final rules for the MA and Part D 

prescription drug programs appeared in 

the Federal Register on January 28, 

2005 (70 FR 4588 through 4741 and 70 

FR 4194 through 4585, respectively). 

Many of the provisions relating to 

applications, marketing, contracts, and 

the new bidding process, for the MA 

program, became effective on March 22, 

2005, 60 days after publication of the 

rule, so that the requirements for both 

programs could be implemented by 

January 1, 2006. All of the provisions 

regarding the new Part D prescription 

drug program became effective on 

March 22, 2005. 

As we have gained more experience 

with the MA and the Part D programs, 

we are revising areas of both programs. 

Many of these revisions clarify existing 

policies or codify current guidance for 

both programs. We believe that these 

changes will help plans understand and 

comply with our policies for both 

programs and aid MA organizations and 

Part D plan sponsors in implementing 

their health care and prescription drug 

benefit plans. 

B. Relevant Legislative History and 

Overview 

The Balanced Budget Act of 1997 

(BBA), Public Law 105–33, established 

a new ‘‘Part C’’ in the Medicare statute 

(sections 1851 through 1859 of the 

Social Security Act (the Act)) which 

provided for a Medicare+Choice (M+C) 

program. Under section 1851(a)(1) of the 

Act, every individual entitled to 

Medicare Part A and enrolled under 

Medicare Part B, except for most 

individuals with end-stage renal disease 

(ESRD), could elect to receive benefits 

either through the Original Medicare 

program or an M+C plan, if one was 

offered where he or she lived. 

The Medicare, Medicaid, and SCHIP 

Balanced Budget Refinement Act of 

1999 (BBRA), Public Law 106–111, 

amended the M+C provisions of the 

BBA. Further amendments were made 

to the M+C program by the Medicare, 

Medicaid, and SCHIP Benefits 

Improvement and Protection Act of 

2000 (BIPA) (Pub. L. 106–554), enacted 

December 21, 2000. 

As noted above, the MMA was 

enacted on December 8, 2003. Title I of 

the MMA added a new ‘‘Part D’’ to the 

Medicare statute (sections 1860D–1 

through 1860D–42) creating the 

Medicare Prescription Drug Benefit 

Program, the most significant change to 

the Medicare program since its 

inception in 1965. 

Sections 201 through 241 of Title II of 

the MMA made significant changes to 

the M+C program which was 

established by the Balanced Budget Act 

of 1997 (BBA) (Pub. L. 105–33). Title II 

of the MMA renamed the M+C program 

the MA program and included new 

payment and bidding provisions, added 

authority for new regional MA plans 

and special needs plans, reestablished 

authority for medical savings account 

(MSA) plans that had been provided in 

the BBA on a temporary basis, and made 

other changes to the provisions of Part 

C. Title I of the MMA created 

prescription drug benefits under 

Medicare Part D, and a new retiree drug 

subsidy program. 

Both the MA and prescription drug 

benefit regulations were published 

separately, as proposed and final rules, 

though their development and 

publication were closely coordinated. 

On August 3, 2004, we published in the 

Federal Register proposed rules for the 

MA program (69 FR 46866 through 

46977) and the Medicare Prescription 

Drug Benefit Program (69 FR 46632 

through 46863). In response to public 

comments on the proposed rules, we 

made several revisions to the proposed 

policies for both programs. For further 

discussion of these revisions, see the 

respective final rules (70 FR 4588–4741) 

and (70 FR 4194–4585). 

Based on what we learned in program 

experience subsequent to the 

promulgation of the initial regulations 

implementing the MMA, on May 16, 

2008, we proposed additional revisions 

to the Part C and D regulations that 

proposed to incorporate certain existing 

policies into the regulations, and make 

some revisions to policies based on 

program experience (73 FR 28556). The 

proposals in this May 16, 2008, notice 

of proposed rulemaking (proposed rule) 

included proposals addressing the 

marketing of Part C and Part D plans to 

Medicare beneficiaries. While the 

proposed rule also included a wide 

range of other proposals, in this final 

rule, we are only finalizing certain 

proposals in the May 16, 2008, proposed 

rule relating to marketing. 

The Medicare Improvements for 

Patients and Providers Act of 2008 

(MIPPA), Public Law 110–275 was 

enacted on July 15, 2008, and amended 

titles XVIII and XIX of the Social 

Security Act to make various revisions 

to the Medicare statute intended to 

improve the Medicare program. Section 

103 established new statutory 

prohibitions and limitations for MA 

plans and Medicare Prescription Drug 

plans (PDPs) on certain sales and 

marketing activities. Many of these new 

statutory marketing provisions were 

similar (or identical) to provisions that 

we proposed in our May 16, 2008, 

proposed rule. For example, MIPPA 

specifically prohibits, while performing 

marketing activities to promote or sell 

MA plans or PDPs, any unsolicited 

means of direct contact with 

beneficiaries, cross-selling of non-health 

related products, and providing meals. 

It also prohibits sales and marketing 


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Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Rules and Regulations 54209 

activities in health care settings 

(excluding common areas) and at 

educational events. 

MIPPA also places limits on other 

marketing activities. Specifically, it 

limits the following: the scope of the 

discussion during an appointment set 

with a beneficiary to discuss an MA 

plan or PDP to what was agreed upon 

with the beneficiary in advance; the 

ability to use names and logos of cobranded network providers on plan 

membership and marketing materials; 

the value of gifts and promotional items 

provided to beneficiaries; and the 

compensation paid by plans to agents 

for selling MA and Part D products. In 

addition, it requires the training and 

testing of agents and brokers selling MA 

and Part D products. MIPPA also 

requires plans and CMS to collaborate 

and share information with the States. 

The above MIPPA provisions enact 

into statute provisions we proposed 

through our authority to establish 

marketing rules through rulemaking, 

and thus effectively would supersede 

our regulatory proposals. Pursuant to 

MIPPA, the marketing prohibitions 

provisions mentioned above apply to 

the plan year beginning on January 1, 

2009. In keeping with statutory intent 

and based on policy concerns related to 

inappropriate marketing activity, we 

believe that regulations setting forth 

important protections for beneficiaries 

should be in effect before the 2009 plan 

year marketing campaign begins this fall 

on October 1, 2008. We are finalizing 

our May 16, 2008 proposals in these 

areas in this final rule so that the 

marketing rules in question can be 

effective for the 2009 benefit year 

marketing campaign, beginning October 

1, 2008. These provisions are set forth 

in this final rule at § 422.2268, 

§ 423.2268, 422.111(b) and 423.128(b). 

Specifically, this final rule finalizes 

six new marketing provisions and 

modifies the disclosure and 

dissemination of Part D information 

provisions and the file and use 

provision set forth in the May 16, 2008, 

proposed rule. The remaining proposals 

in the proposed rule either were 

superseded by statutory provisions that 

we will reflect in the regulations as part 

of an interim final rule, or will be 

finalized in a future final regulation in 

which we will respond to any public 

comments on those proposals in the 

May 16th proposed rule that were not 

superseded by MIPPA provisions. 

II. Provisions of the Proposed 

Regulations 

Because this final rule finalizes only 

the recodification and modification of 

existing sections of the marketing 

regulations at § 422.80, § 423.50, 

§ 422.111, and § 423.128 and finalizes 

only six of the new provisions from the 

proposed rule, we shall only discuss 

these aspects of the May 16, 2008 

proposed rule here. The following table 

displays how the proposed rule 

proposed to recodify existing marketing 

provisions, and the bullets that follow 

the table set forth those proposals in the 

May 16, 2008 proposed rule that we are 

addressing in this final rule. 

TABLE 1—PROVISIONS AFFECTING BOTH THE PART C AND PART D PROGRAMS

Provision Part 422—subpart Part 422 

CFR section Part 423 subpart Part 423 CFR section 

Marketing: Definitions ........................ Subpart V (all marketing sections) ... 422.2260 Subpart V (all marketing sections) ... 423.2260 

Review and Distribution of Marketing 

Materials.

........................................................... 422.2262 ........................................................... 423.2262 

Guidelines for CMS Review .............. ........................................................... 422.2264 ........................................................... 423.2264 

Deemed Approval ............................. ........................................................... 422.2266 ........................................................... 423.2266 

Marketing: Standards for MA/Part D 

marketing.

........................................................... 422.2268 ........................................................... 423.2268 

Marketing: Licensing of marketing 

representatives and confirmation 

of marketing resources.

........................................................... 422.2272 ........................................................... 423.2272 

Marketing: Employer group retiree 

marketing.

........................................................... 422.2276 ........................................................... 423.2276 

Disclosure requirements and Dissemination of Part D information.Subpart C ......................................... 422.111 Subpart C ......................................... 423.128 

• § 422.2262(b) and § 423.2262(b)— 

we proposed to eliminate the file and 

use eligibility process. 

• § 422.2268(b) and § 423.2268(b)— 

we proposed to prohibit the offering of 

gifts to potential enrollees unless the 

gifts are of nominal value, and prohibit 

providing meals to beneficiaries while 

conducting marketing activities. We are 

only finalizing the prohibition on meals 

in this final rule, and thus are separating 

these two prohibitions. The nominal 

gifts provision will be addressed in a 

separate rule that implements the 

requirement that new MIPPA rules be in 

place no later than November 15, 2008. 

• § 422.2268(d) and § 423.2268(d)— 

we proposed to extend the prohibition 

against door-to-door solicitation to 

include other instances of unsolicited 

direct contact including outbound 

telemarketing without the beneficiary 

initiating contact. 

• § 422.2268(f) and § 423.2268(f)—we 

proposed to prohibit the cross-selling of 

non-health care related products during 

any sales, marketing, or presentation for 

an MA plan or PDP. 

• § 422.2268(k) and § 423.2268(k)— 

we proposed to prohibit conducting 

sales presentations or distributing and 

accepting plan applications in provider 

offices or other places where health care 

is delivered. 

• § 422.2268(l) and § 423.2268(l)—we 

proposed to prohibit conducting sales 

activities, distributing, or collecting 

applications at education events. 

• § 422.2272(c) and § 423.2272(c)— 

we proposed that plans must appoint 

and use only State licensed 

representatives to conduct direct 

marketing activities in accordance with 

applicable State appointment laws. 

• § 422.111 and § 423.128—we 

proposed that plans must disclose the 

information specified in §§ 422.111(b) 

and 423.128(b) to its members both at 

the time of enrollment and at least 

annually thereafter, 15 days before the 

annual coordinated election period. 

III. Analysis of and Response to Public 

Comments 

We received a total of 405 timely 

comments on the May 16, 2008 

proposed rule, and will only address 

here those comments that pertain to the 

proposals we are finalizing in this final 

rule. We received comments from 

managed care organizations and other 

insurance industry representatives, 

pharmacy benefit management firms, 


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54210 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Rules and Regulations 

pharmacies and pharmacy education 

and practice-related organizations, 

beneficiary advocacy groups, 

representatives of health care providers, 

States, employers and benefits 

consulting firms, members of Congress, 

beneficiaries, and others. The comments 

ranged from general support or 

opposition to the proposed provisions to 

very specific questions or comments 

regarding the proposed changes. 

Brief summaries of each proposed 

provision, a summary of the public 

comments we received, and our 

responses to the comments are set forth 

below. 

Medicare Advantage and Prescription 

Drug Program Marketing Requirements 

(Proposed New Subparts V) 

A. General 

In order to implement standards 

consistent with ‘‘fair marketing’’ 

practices in accordance with sections 

1851(h) and 1860D–1(b)(1)(B)(vi) of the 

Act, and to ensure beneficiaries receive 

the necessary information to make 

informed choices during the annual 

election period, we proposed to amend 

and expand our marketing regulations 

for both the MA and the Part D 

programs. Moreover, due to the 

proposed addition of new marketing 

provisions and the need to clarify 

current marketing regulations, we 

proposed to remove §§ 422.80 and 

423.50 of subpart B, which currently 

specify the requirements related to the 

approval of marketing materials and 

instead include this core of our 

marketing requirements in a new 

subpart V at 42 CFR parts 422 and 423 

specific to the marketing regulations for 

each program. 

Comment: We received several 

comments recommending changes to 

the content of the existing requirements 

contained in § 422.80 and § 423.50. 

Response: In the proposed rule we 

made no changes to the requirements in 

§§ 422.80 and 423.50 other than to 

include them in a new subpart V 

(§§ 422.2260 and 423.2260). Because we 

did not propose modifications to the 

content of this section in the proposed 

rule other than relocating the text to a 

new subpart, the comments are beyond 

the scope of this regulation. However, 

there is one exception. A commenter 

requested that we remove the second 

sentence at §§ 422.2268(a) and 

423.2268(a) because it creates ambiguity 

with respect to the prohibition outlined 

in the first sentence. We agree and are 

removing the sentence. 

Comment: One commenter expressed 

concern about the time frame for 

implementing certain provisions prior 

to the annual election period (AEP) and 

open enrollment period (OEP) and 

recommended that the effective date of 

any provisions of the final regulations 

be effective after the 2009 AEP and OEP 

(April 1 or later). Other commenters 

expressed their desire for the provisions 

to be effective no sooner than 2010. 

Response: This final rule contains the 

six provisions from the May 2008 

proposed rule that we believe should be 

implemented prior to October 1, 2008, 

the beginning of the marketing period 

for contract year 2009, in order to 

protect beneficiaries during the annual 

election period. These six provisions are 

in accordance with requirements 

contained in section 103 of MIPPA that 

will take effect by operation of statute 

on January 1, 2009. In light of our 

program experience, we believe that the 

beneficiary protections in these six 

provisions should be put into effect 

before the 2009 benefit year marketing 

campaign and annual election period. 

Other provisions from the May 2008 

proposed rule will be addressed in 

separate regulations, one will reflect 

other statutory provisions in MIPAA, 

and one will respond to comments on 

the other provisions in the May 2008 

proposed rule that were not addressed 

in MIPAA. We will consider this 

comment in relation to the latter 

remaining provisions. 

Comment: A few commenters 

requested clarification of the extent to 

which the proposed marketing 

requirements apply to cost plans or 

employer group plans; recommending 

that, if the proposed marketing 

requirements do not apply to cost plans 

or employer group plans, CMS modify 

the regulations to apply the proposed 

marketing requirements to such plans. 

Response: Cost plans are subject to 

provisions found in § 417.28 and the 

guidance contained in the Medicare 

Marketing Guidelines for: Medicare 

Advantage Plans, Medicare Advantage 

Prescription Drug Plans, Prescription 

Drug Plan, 1876 Cost Plans. Employer 

group plans are MA and Part D plans. 

Additional guidance on employer group 

plans will be forthcoming in chapter 9 

of the Medicare Managed Care Manual. 

The statutory provisions that the 

provisions of this final rule mirror only 

apply to MA plans under Part C and 

PDPs under Part D. 

B. Review and Distribution of Marketing 

Materials: File and Use (§ 422.2262(b), 

§ 423.2263(b)) 

In addition to moving our 

requirements concerning the approval of 

marketing materials and election forms 

to §§ 422.2262 and 423.2262 of the Part 

C and Part D program regulations, 

respectively, we are proposing to 

modify the ‘‘file and use’’ review 

process. 

While the statute requires the 

submission of marketing materials to 

CMS for a 45 day period of CMS review, 

based on years of program experience 

CMS recognized that some MA 

organizations consistently met all 

marketing standards, and that their 

marketing materials warranted less 

scrutiny. CMS accordingly established a 

file and use policy that was designed to 

streamline the marketing materials 

approval process for these MA plans. 

Under this file and use policy, Medicare 

health plans that demonstrated to the 

satisfaction of CMS that they 

continually met a particular high 

standard of performance were able to 

publish and distribute certain marketing 

materials within 5 days of submission to 

CMS under section 1851(h)(1), without 

waiting for a response from CMS. 

In effect, these materials were deemed 

approved by CMS after 5 days based on 

CMS’s prior review of earlier materials. 

The criteria in order to be eligible for 

the original file and use policy were that 

a contracting entity had to have 

submitted at least eighteen months of 

marketing materials for CMS review, 

and at least ninety percent of the 

materials submitted within the past six 

months had to meet applicable 

marketing standards. 

In the regulations implementing the 

MMA, CMS adopted a separate file and 

use policy that was based on the nature 

of the marketing materials in question, 

rather than the track record of the MA 

organization or PDP sponsor. Under this 

policy, an MA organization or PDP 

sponsor certifies that it is using either 

model language already reviewed and 

approved by CMS, or types of marketing 

materials that CMS has identified as not 

containing substantive content. As with 

the original policy that focused on the 

organization, the materials covered by 

this new file and use certification policy 

could be used 5 days after submission, 

without any explicit approval from 

CMS. In the case of MA organizations, 

this certification is made at the time of 

submission, while PDP sponsors are 

permitted to so certify in their contracts. 

In order to level the playing field 

among contractors, eliminate 

redundancies, and focus resources on 

materials that have content that 

warrants CMS scrutiny, we are 

proposing to eliminate file and use 

status based on an organization’s track 

record, and apply a uniform policy of 

applying the file and use policy to 

marketing materials that either use 

model language without substantive 

modification, or materials that are 


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identified by CMS as not containing 

substantive content warranting CMS 

review. The same approach to certifying 

that these types of materials are being 

used would apply for both MA 

organizations and Part D sponsors. We 

would include the proposed file and use 

provision in § 422.2262(b) and 

§ 423.2262(b) of the MA and Part D 

programs, respectively. 

Comment: There were several general 

comments on the CMS review process 

for marketing materials, including a 

request for further definition of 

‘‘substantive content.’’ 

Response: Over the past 2 years CMS 

has implemented several mechanisms to 

enhance the consistency of our review 

process, and we will continue to refine 

our processes. We consider the 

suggestion to make more materials 

eligible for file and use a good one, and 

we have done so recently and may 

continue to do so in the future. A list 

of materials CMS has identified as ‘‘not 

containing substantive content’’ and 

eligible for file and use is available in 

the Health Plan Management System 

(HPMS) marketing module. With respect 

to shortening the review period to 30 

days, the statute requires the submission 

of marketing materials to CMS for a 45- 

day period of review. Materials that are 

not deemed eligible for the 5-day file 

and use policy must be submitted for a 

45-day review period. Finally, CMS will 

take under consideration suggestions to 

clarify the review process for plans that 

operate in more than one geographic 

area, and to allow such plans to submit 

materials to the lead office only for 

review. 

Comment: One commenter agrees 

with the 45-day rule for marketing 

materials, but suggests that CMS attach 

the civil monetary penalty (per enrollee 

affected) as penalty for violating the 

certification without exceptions. 

Response: CMS may impose a civil 

monetary penalty (CMP) on an 

organization when the organization’s 

conduct adversely affects or has the 

substantial likelihood of adversely 

affecting one or more enrollees. One of 

the violations for which a CMP can be 

assessed is that the organization 

substantially fails to comply with 

marketing requirements 

(§§ 422.510(a)(12) and 423.509(a)(9)). If 

CMS determines an organization’s 

substantial failure to adhere to 

marketing requirements has adversely 

affected or has the substantial likelihood 

of adversely affecting one or more 

enrollees, CMS may impose a CMP. It is 

important to note that CMS has other 

enforcement options, such as marketing 

and enrollment sanctions, for 

organizations that fail to adhere to 

marketing requirements. Under these 

sanctions, CMS may restrict a plan from 

marketing during marketing season or 

from accepting new enrollments for a 

period of time. For example, since 

marketing season begins on October 1st 

of every year, CMS may decide to 

impose a sanction against a plan for a 

marketing violation that prevents the 

plan from marketing until a later date, 

such as October 15th or November 1st. 

Similarly, CMS may prohibit a plan 

from accepting new enrollments for 

several months. 

Comment: We received several 

comments in support of this rule 

change, and one comment opposing our 

elimination of the file and use policy for 

marketing materials. 

Response: Section 423.2262 does not 

eliminate the file and use process, it 

only eliminates the file and use status 

based on an organization’s track record. 

Instead a uniform policy will be 

applied, so that all contractors are 

eligible to submit any material deemed 

file and use qualified. 

Comment: CMS received one 

comment that this change will over 

burden CMS and could lead to a 

negative impact on members. CMS must 

release models in time for document 

preparation and review time to be 

allowed. 

Response: The elimination of file and 

use based on status will not increase the 

number of documents that CMS must 

review through the 45-day review 

process—model documents previously 

eligible for file and use will remain 

eligible for file and use. In addition, 

CMS is moving towards more 

standardization of certain model 

documents, which will then increase 

the number of documents eligible for 

file and use, thereby significantly 

shortening the amount of time required 

for CMS review. CMS has successfully 

released several model documents for 

plan review and modification earlier in 

the year, and will continue towards that 

goal. 

Comment: Several comments 

suggested that CMS should add a 

requirement that plan sponsors file 

marketing materials with State 

regulators, so that States will be able to 

differentiate between CMS-approved 

and unapproved material and take 

action accordingly. 

Response: It is not necessary for plans 

to file marketing materials with State 

regulators. All CMS approved marketing 

materials contain a unique material 

identification number. If anyone has a 

question about the legitimacy of plan 

marketing material, they can report it to 

CMS and it will be verified. If CMS 

determines that the material was not 

reviewed and approved prior to use, we 

will initiate a compliance action. If CMS 

determines that the material was 

appropriately submitted and approved, 

but determines as a result of a complaint 

that there is a problem with the 

material, it will contact the plan to have 

the material taken out of use. 

C. Standards for MA and PDP Marketing 

(§§ 422.2268, 423.2268) 

We proposed making an 

organizational change for this section, 

consistent with our proposal to create a 

new subpart V at 42 CFR part 422 and 

part 423 specific to marketing 

regulations. We are redesignating 

§§ 422.80 and 423.50 as §§ 422.2268 and 

423.2268, respectively. 

Comment: We received several 

comments requesting that we clarify 

that pharmacies are not obligated to 

distribute plan information to 

beneficiaries for Part D plans with 

which they do not have contracts. One 

commenter stated they do not believe 

that pharmacies should be prevented 

from providing comparative Part D plan 

information to patients if they do not 

accept and display marketing materials 

from all Part D sponsors. A commenter 

stated that some pharmacies may not 

contract with some Part D plans, and as 

a result may not be familiar with their 

terms and conditions nor have ready 

access to those plans’ marketing 

materials. Some commenters also stated 

that the regulatory language in proposed 

§ 422.2268(j) was not consistent with 

§ 423.2268(j). Commenters stated that 

the final Part D technical rule that 

published April 15, 2008, (73 FR 20486) 

modified 42 CFR 423.50(f) requiring 

providers such as a pharmacy provider 

to display and distribute comparative 

plan marketing materials only from 

plans with which the provider 

contracts. One commenter 

recommended that CMS retain the 

recently amended § 423.50(f) and 

remove the language proposed in 

§ 422.2268(j) and § 423.2268(j). There 

were also some commenters that 

opposed the existing provision. 

Response: We are revising proposed 

§ 423.2268(j) to be consistent with 

§ 423.50(f)(v) as published in the Policy 

and Technical Changes to the Medicare 

Prescription Drug Benefit final rule (73 

FR 20486) to include ‘‘ accept and 

display materials from MA 

organizations or Part D plan sponsors 

with which the provider, provider group 

or pharmacy is contracted.’’ We are also 

modifying the regulatory language in 

§ 422.2268(j) to be consistent with the 

language provided in § 423.2268(j). With 

respect to commenters that opposed the 

provision, as opposed to seeking 


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clarification, these comments are 

outside the scope of this rulemaking. 

Comment: One commenter contended 

that this provision does not reflect 

guidance CMS issued October 30, 2006, 

that allows comparisons to be limited to 

SNPs as long as the remaining MA plans 

are identified. The Commenter 

recommended having this guidance 

explicitly recognized in the new 

regulation. 

Response: The guidance released on 

October 30, 2006, references provider 

affiliation announcements in which 

SNPs may announce an ongoing 

affiliation or arrangement. This 

guidance will be included in the 

updated Medicare Marketing Guidelines 

for: Medicare Advantage Plans, 

Medicare Advantage Prescription Drug 

Plans, Prescription Drug Plan, 1876 Cost 

Plans and other guidance. This 

guidance requires that all affiliated 

plans be listed on affiliation 

announcements. In some cases, a 

disclaimer indicating that other plans 

are available is required. Highlighting 

the affiliated SNP plans within the list 

of all affiliated plans or listing the 

affiliated SNP plans along with the 

disclaimer is consistent with our 

guidance. 

Comment: One commenter requested 

that CMS continue to allow providers to 

use an objective third party to create 

MA health plan benefit comparisons (all 

or a subset) that are distributed to 

beneficiaries/patients consistent with 

the Medicare marketing guidelines. 

Response: This is still allowed. The 

Medicare Marketing Guidelines for: 

Medicare Advantage Plans, Medicare 

Advantage Prescription Drug Plans, 

Prescription Drug Plan, 1876 Cost Plans 

provides specific guidance for materials 

created by third parties. 

D. Employer Group Retiree Marketing 

(§§ 422.2276, 423.2276) 

We proposed an organizational 

change for this section, consistent with 

our proposal to create a new subpart V 

at 42 CFR part 422 and part 423 specific 

to marketing regulations. We are 

redesignating § 422.80(f) as § 422.2276 

and, to be consistent, are adding 

§ 423.2276. 

Comment: We received no comments 

about the reorganization or the addition 

of § 423.2276. The only comments 

received expressed a concern about 

employer group marketing materials not 

being subject to prior review and 

approval. 

Response: We have considered this 

comment and believe that employer 

group marketing is very different from 

marketing individual plans. Therefore, 

we are finalizing the provision without 

modification. 

E. Licensing of Marketing 

Representatives and Confirmation of 

Marketing Resources (§§ 422.2272, 

423.2272) 

In response to questions from the Part 

D industry regarding State licensure of 

marketing representatives, we adopted 

in our Medicare Marketing Guidelines 

for: Medicare Advantage Plans, 

Medicare Advantage Prescription Drug 

Plans, Prescription Drug Plan, 1876 Cost 

Plans the requirement that MA 

organizations and Part D sponsors that 

conduct marketing through employees 

or independent agents use Statelicensed, certified, or registered 

individuals to do so, if a State licenses 

such agents. The use of only Statelicensed marketing representatives 

helps ensure that the marketing 

representatives meet minimum 

standards of integrity and 

professionalism in order to market to 

Medicare-eligible beneficiaries. This 

Medicare requirement permits Medicare 

to benefit from State efforts to deny 

licensure to under-educated, 

unscrupulous or otherwise substandard 

individuals, and helps ensure that 

Medicare beneficiaries are not the 

victims of substandard or inappropriate 

marketing activities. 

Based on the experience we have 

gained since the start of the Part D 

program, and continued experience 

with the Medicare Advantage program, 

we proposed to codify in the regulation 

our existing requirement that MA 

organizations and Part D sponsors 

utilize only State-licensed marketing 

representatives to do marketing in the 

States that license such agents. 

We further proposed to add a 

regulatory requirement to §§ 422.2272 

and 423.2272 that MA organizations and 

PDP sponsors that market through 

agents, not only be required to use 

licensed agents, but would be required 

to report to States that they are using 

such agents, in a manner consistent 

with State appointment laws. State 

appointment laws require MA and PDP 

sponsors to appoint marketing 

representatives before the agent can 

market a plan’s product. Appointment 

laws may require an insurance plan to 

maintain a registry of marketers who 

sell their plans, including maintaining a 

list of license numbers, dates the 

individual began selling policies for the 

insurance company, and stopped selling 

plans for the insurance company. While 

we previously required only that 

licensed agents be used, and did not 

require that the appointment of such 

agents be reported to the State agency 

that regulates agents, we believe this 

latter requirement would enable States 

to monitor the agents’ activities in 

connection with their Medicare 

marketing for the purpose of monitoring 

the agent’s fitness to engage in 

marketing in the State. We believe 

Medicare beneficiaries would benefit 

from this State monitoring. 

We recognize that, under the 

preemption provisions in section 

1856(b)(3) of the Act (incorporated for 

PDPs under section 1860D–12(g)), States 

do not have the authority to regulate the 

marketing of Medicare Part C and D 

plans. However, as noted, any abuses by 

an agent in marketing such plans would 

have direct relevance to the State’s 

oversight of the agent generally, and 

implications for the agent’s marketing of 

products over which the State has 

jurisdiction, and Medicare beneficiaries 

would benefit from having the agents 

who engage in Medicare marketing 

subject to this State oversight. 

In the context of the requirement that 

MA organizations and Part D sponsors 

utilize only State-licensed marketing 

representatives, and report the 

appointment of such agents to States 

consistent with the procedures under 

State appointment laws, it is important 

to discuss the activities that would not 

trigger the need for using State-licensed 

marketing representatives. As standard 

practice, MA organizations and Part D 

sponsors employ customer service 

representatives who answer questions 

and accept enrollments on behalf of 

enrollees who have decided to enroll in 

a particular plan offered by the 

organization. We recognize that plan 

customer service representatives play an 

important role in disseminating 

information by answering factual 

questions posed by beneficiaries, and 

that such an activity is distinguishable 

from the act of steering to a plan 

(‘‘marketing,’’ as defined in the 

Medicare Marketing Guidelines for: 

Medicare Advantage Plans, Medicare 

Advantage Prescription Drug Plans, 

Prescription Drug Plan, 1876 Cost 

Plans). 

Additionally, taking demographic 

information from someone who has 

decided to enroll in the plan, in order 

to complete an application, is not 

steering in that the beneficiary has 

already made a choice to enroll in a 

plan. Accordingly, we believe providing 

factual information, fulfilling a request 

for materials, and taking demographic 

information in order to complete an 

enrollment application at the initiative 

of the enrollee by a customer service 

representative (CSR), are legitimate 

customer service activities that would 


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not trigger the need for using Statelicensed marketing representatives. 

Comment: Many commenters agreed 

with the requirement that MA 

organizations and Part D sponsors that 

conduct marketing through agents must 

use State-licensed, certified, or 

registered individuals. 

One commenter urged that the 

proposed rule on licensed agents 

include clarifying language similar to 

the language in the preamble, and in the 

Medicare Marketing Guidelines for: 

Medicare Advantage Plans, Medicare 

Advantage Prescription Drug Plans, 

Prescription Drug Plan, 1876 Cost Plans. 

Response: We have considered this 

comment and have determined that the 

proposed provision should be finalized 

without modification. The Medicare 

Marketing Guidelines for: Medicare 

Advantage Plans, Medicare Advantage 

Prescription Drug Plans, Prescription 

Drug Plan, 1876 Cost Plans provide the 

clarification requested and we believe 

that the guidelines are the appropriate 

vehicle to do this. 

Comment: A few commenters asked if 

the appointment of agents/brokers was 

warranted for stand-alone prescription 

drug plans (PDPs), because the 

marketing of these plans differs 

significantly from MA and MA–PD 

marketing. 

Response: We believe that while the 

marketing of MA plans may differ from 

PDPs, in accordance with provisions in 

section 103 of MIPPA that will take 

effect on January 1, 2009, we are, in this 

final rule, requiring effective October 1, 

2008, that MA organizations and PDP 

sponsors appoint their marketing 

representatives before the agents can 

begin to market a plan’s product. 

Comment: A few commenters would 

like the requirement for the licensing 

and appointment of independent 

agents/brokers to be effective on January 

1, 2010 or later. 

Response: As we have learned from 

our experience over the past several 

years and in order to better protect 

Medicare beneficiaries from practices 

that could mislead or confuse them, we 

believe that this requirement must be 

implemented before the fall 2008 

marketing period during which plans 

for 2009 are marketed. These provisions 

would take effect by operation of 

MIPAA effective January 1, 2009, even 

if we had not acted to finalize these 

provisions of the proposed rule in this 

regulation. Therefore, we will proceed 

with implementing these rules as final 

and effective October 1, 2008. 

Comment: Many commenters 

suggested that all MA and PDP 

enrollment applications should include 

the National Insurance Producer 

Registry (NIPR) license number. A few 

commenters urged more expansive CMS 

oversight and greater investment of 

resources in enforcement. 

Response: We believe that States 

currently provide appropriate oversight, 

and have the necessary reporting 

mechanisms in place to track and 

monitor agent activity. The intent of this 

requirement is to strengthen our ability 

to collaborate with States in addressing 

fraudulent and inappropriate marketing 

practices. 

Comment: A number of commenters 

requested that CMS develop guidance 

specifying the information that Plans 

must provide to States and establish a 

streamlined process for data 

submission. 

Response: We believe States currently 

provide appropriate oversight and have 

the necessary reporting mechanisms in 

place to track and monitor agent 

activity. The intent of this requirement 

is to provide support to States as they 

exercise their oversight authority and 

we note that the requirement we are 

finalizing is generally in accordance 

with the Medicare Improvements for 

Patients and Providers Act (MIPPA). We 

will consider this comment when 

updating marketing guidance in the 

future. 

Comment: Many commenters noted 

that our proposed regulatory language 

did not clearly state that CMS is 

requiring action that parallels 

information requirements under State 

appointment laws, because the 

regulation did not require compliance 

with all aspects of the State 

appointment process. By preventing the 

application of any State fees pursuant to 

the State appointment process, and 

requiring plans only to report to States 

that they are acting ‘‘consistent with the 

appointment process’’ may undermine 

States’ ability to enforce their own 

appointment laws. 

A few commenters believed CMS 

should revise this section to clarify that 

State agent appointment laws are 

enforceable against MA and Part D plan 

sponsors. 

Response: We have considered these 

comments. Section 103 of MIPPA 

requires that plans pay fees to States 

under appointment laws, effective 

January 1, 2009. 

Comment: A commenter questioned if 

CSRs who respond to beneficiaries’ 

requests for a meeting with an agent 

need to be licensed. 

Response: As discussed in the 

preamble, we recognize that CSRs play 

an important role disseminating 

information by performing activities like 

answering factual questions posed by 

beneficiaries. These activities are 

activities that we distinguish from 

activities that could result in steering a 

beneficiary to a particular plan. In 

keeping with that context, Customer 

Service Representatives (CSRs) 

scheduling agent appointments in 

response to a beneficiary request is not 

an activity that would require a licensed 

agent to fulfill. 

Comment: A commenter asked if a 

CSR could answer questions about plans 

offered by a sponsor. 

Response: Section 422.2272 permits 

CSRs to answer factual questions posed 

by beneficiaries. 

Comment: A few commenters asked 

whether employees of external agents 

and brokers who perform ‘‘customer 

service’’ functions, but are not involved 

in the actual selling of plan products, 

could also do so without being Statelicensed or appointed. 

Response: Individuals performing 

customer service functions such as 

providing factual information, fulfilling 

a request for material, and taking 

demographic information are 

considered CSRs. When performing 

these functions, they do not need to be 

State-licensed or appointed. 

E. Standards for MA/Part D Marketing 

(§§ 422.2268 and 423.2268) 

In addition, we also proposed to 

clarify in §§ 422.2268 and 423.2268 

several standards for MA and PDP 

marketing. In §§ 422.2268(d) and 

423.2268(d) we clarify that the 

prohibition on door-to-door solicitation 

includes other instances of unsolicited 

direct contact, such as outbound calling 

without the beneficiary initiating 

contact, calling to confirm that the 

beneficiary is in receipt of mailed 

information, and accepting 

appointments made by third parties or 

independent agents without the 

beneficiary initiating contact; but does 

not include calling existing members. 

Although, plans may not contact former 

members who have disenrolled or are in 

the process of disenrolling. We believe 

this clarification would help prevent 

inappropriate conduct on the part of 

agents in aggressively pursuing the 

marketing of MA plans and PDPs to 

beneficiaries outside of approved 

common areas that may be used for 

marketing displays and presentations 

(for example, approaching beneficiaries 

directly in parking lots). 

We also proposed to clarify in 

§§ 422.2268(l) and 423.2268(l) that 

plans may not engage in sales or 

marketing activities, including the 

distribution or collection of plan 

applications, at educational events. 

These events may be sponsored by plans 

or by outside entities, and are events 


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that are promoted to be educational in 

nature and have multiple vendors, such 

as health information fairs, conference 

expositions, State-or communitysponsored events, etc. In §§ 422.2268(k) 

and 423.2268(k) we clarified that sales 

and marketing activities, including the 

distribution or collection of plan 

applications, are only permitted in 

common areas of health care settings 

(for example, hospital cafeterias or 

conference rooms), and would be 

prohibited in areas where patients 

primarily intend to receive health care 

services (for example, waiting rooms 

and pharmacy counter areas). The term 

‘‘health care setting’’ refers to all 

settings where providers operate, 

including but not limited to pharmacies, 

physicians’ offices, hospitals, and longterm care facilities. In the proposed rule, 

we added § 423.2268(i) to be consistent 

with § 422.2268(i). We received no 

comments on this change. 

We further proposed a regulatory 

requirement in §§ 422.2268 and 

423.2268, providing additional 

protections to ensure beneficiaries are 

not the victims of inappropriate 

marketing techniques. In §§ 422.2268(f) 

and (b) and § 423.2268(f) and (b), we 

proposed to prohibit in any MA or Part 

D sales activity or presentation, the 

provision of meals or the cross-selling of 

non-health care related products to a 

prospective enrollee. 

Comment: Commenters that 

supported the unsolicited contact 

prohibition requested that CMS further 

define cold calls by clarifying if calls are 

permissible to the following: (1) Existing 

membership and beneficiaries that have 

an existing relationship with a 

producer, (2) business reply cards, and 

(3) follow-up calls on plan mailings. 

Response: These clarifications will be 

updated in the Medicare Marketing 

Guidelines for: Medicare Advantage 

Plans, Medicare Advantage Prescription 

Drug Plans, Prescription Drug Plan, and 

1876 Cost Plans and other guidance. 

Comment: Many of the comments 

were not wholly opposed to the 

prohibition on meals, and instead were 

requesting clarification on the definition 

of meals. 

Response: Comments received will be 

taken under consideration when 

updating the Medicare Marketing 

Guidelines for: Medicare Advantage 

Plans, Medicare Advantage Prescription 

Drug Plans, Prescription Drug Plan, and 

1876 Cost Plans and other guidance. 

Comment: Several commenters 

opposed the provision prohibiting 

outbound calls. Some stated that it is 

too restrictive, minimizes growth in the 

program, and is inconsistent with 

common marketing practices. 

Commenters stated that restricting calls 

will prevent beneficiaries from learning 

about their full range of healthcare 

options and is considered 

discriminatory since it creates an 

imbalance with Medigap plans. Some 

commenters stated this provision 

impacts low-income and non-English 

speaking populations where 

communication through mailings has 

been less effective, specifically 

beneficiaries with Medicare and 

Medicaid. Commenters also stated that 

the current CMS rules in the Medicare 

Marketing Guidelines for: Medicare 

Advantage Plans, Medicare Advantage 

Prescription Drug Plans, Prescription 

Drug Plan, 1876 Cost Plans provides 

adequate protection. Commenters that 

supported the provision on unsolicited 

contacts recommended that CMS 

implement reporting requirements to 

identify and prevent unsolicited doorto-door sales and require documentation 

on how an invitation was secured for an 

in-home presentation. 

Response: We believe that this change 

is necessary to ensure the protection of 

beneficiaries from inappropriate or 

fraudulent marketing activities such as 

high-pressure sales tactics or 

inappropriate use of beneficiary 

information. Section 103 of MIPPA 

prohibits unsolicited means of direct 

contact including door-to-door 

solicitation or any outbound 

telemarketing, and therefore we will 

proceed without modification in the 

final regulation. The Medicare 

Marketing Guidelines for: Medicare 

Advantage Plans, Medicare Advantage 

Prescription Drug Plans, Prescription 

Drug Plan, 1876 Cost Plans and other 

guidance are also in the process of being 

updated and will set forth in detail 

requirements for outbound calls to 

existing membership and plan mailings. 

In response to the comment regarding 

reporting requirements for door-to-door 

solicitation and in-home appointments, 

we will consider including detailed 

guidance in the Medicare Marketing 

Guidelines for: Medicare Advantage 

Plans, Medicare Advantage Prescription 

Drug Plans, Prescription Drug Plan, 

1876 Cost Plans and other guidance. 

However, organizations should have 

internal reporting requirements 

established to maintain appropriate 

oversight of these and all marketing 

activities. 

Comment: Some commenters opposed 

the provision that prohibits sales 

activities at educational events. One 

commenter suggested that CMS require 

agents and brokers to register with their 

carrier and CMS at seminars and group 

sales events. Enrollments should be 

allowed to take place as a result of the 

seminar at the end or at a later date. 

Many commenters stated that 

enrollment materials should be 

available for distribution only. 

Commenters supporting the provision 

also suggested that there should be a 

disclaimer provided at education events 

that states, ‘‘This is an education event 

only and no sales activity will be 

conducted, including distribution or 

collection of plan applications.’’ Many 

commenters requested additional 

clarification on the difference between 

sales events and education events. 

Commenters also stated they are 

concerned with CMS’ ability to enforce 

this provision. 

Response: We believe the sole 

purpose of an education event is to 

provide objective information about the 

Medicare program, not steering an 

enrollee towards a specific plan or 

limited number of plans. When a 

beneficiary receives informational 

materials used to promote an 

organization or materials that include 

enrollment information for an 

organization, this is considered a 

marketing activity. Additionally, section 

103 of MIPPA prohibits sales or 

marketing activities for enrollment in 

MA plans in the healthcare setting or at 

educational events except in common 

areas of healthcare settings. Therefore, 

we are finalizing the provision as 

proposed. We will also further clarify 

here that sales activities or sales events 

are marketing activities that steer or 

attempt to steer, an undecided potential 

enrollee towards a plan, or limited 

number of plans, including an effort that 

involves compensation directly or 

indirectly to the party conducting the 

effort if it may lead to enrollment in a 

plan. In response to the disclaimer 

requirement for education events, we 

will consider this requirement when 

updating the Medicare Marketing 

Guidelines for: Medicare Advantage 

Plans, Medicare Advantage Prescription 

Drug Plans, Prescription Drug Plan, 

1876 Cost Plans and other guidance. 

Comment: One commenter suggested 

that CMS develop easy to understand 

educational materials and require plans 

to distribute those materials to 

beneficiaries, regarding the 

disenrollment options available to 

beneficiaries who may have erroneously 

or inappropriately enrolled in an MA– 

PD or a Private-Fee-for-Service Plan. 

Response: We will consider 

additional methods for ensuring 

beneficiaries are aware of their options 

to disenroll if the beneficiary has been 

erroneously or inappropriately enrolled 

in an MA–PD or a Private-Fee-forService Plan. However, CMS currently 

provides several resources that 


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organizations can access to provide 

educational information on the 

Medicare Program. For example, plans 

may refer to the CMS partnership Web 

site for general outreach and education 

information at http://www.cms.hhs.gov/ 

partnerships. Also beneficiaries may be 

referred to 1–800–MEDICARE if they 

have been inappropriately enrolled in a 

health plan. 

Comment: We received several 

comments stating that the provision for 

plan sales activities in a healthcare 

setting is inconsistent with the Medicare 

Marketing Guidelines for: Medicare 

Advantage Plans, Medicare Advantage 

Prescription Drug Plans, Prescription 

Drug Plan, 1876 Cost Plans and is overly 

restrictive. Commenters requested 

clarification on the phrase ‘‘other places 

where healthcare is delivered’’, and 

suggested instead to prohibit such 

activities in ‘‘provider offices, other 

places where a healthcare provider 

delivers healthcare services to a 

Medicare beneficiary’’. One commenter 

suggested that CMS model the language 

included in the recently passed 

Medicare bill (MIPPA). Some 

commenters stated that sales activities 

and applications should be prohibited at 

pharmacies and any part of a retail store 

in which a pharmacy is located. 

Response: We have reviewed this 

comment and will revise §§ 422.2268(k) 

and 423.2268(k) to include the 

following language from section 103 of 

MIPPA ‘‘areas where health care is 

delivered to individuals, except in the 

case where such activities are 

conducted in common areas in health 

care settings.’’ 

Comment: Commenters recommended 

that CMS amend the rule to clarify that 

marketing may not take place in areas 

within healthcare settings where 

individuals receive care, rather than in 

the entire building. 

Response: We have considered the 

comment; however, we will retain the 

provision as proposed. Clarification is 

provided in the Medicare Marketing 

Guidelines for: Medicare Advantage 

Plans, Medicare Advantage Prescription 

Drug Plans, Prescription Drug Plan, 

1876 Cost Plans where we state 

‘‘Common areas, where marketing 

activities are allowed, include areas 

such as hospital or nursing home 

cafeterias, community or recreational 

rooms and conference rooms. If a 

pharmacy counter is located within a 

retail store, common areas would 

include the space outside of where 

patients wait for services or interact 

with pharmacy providers and obtain 

medications.’’ 

Comment: Commenters stated that 

CMS did not address in the preamble or 

proposed regulation sales activities in 

hospitals or skilled nursing facilities. 

Some commenters stated that the 

provisions will impact seniors who are 

hospitalized or living in long-term care 

facilities, and that a waiver should be 

signed to allow marketing in any section 

that is available. Commenters also stated 

that this provision would impact 

beneficiaries that receive care from 

dialysis facilities where they lack 

common areas such as lobbies or 

patient-accessible areas. 

Response: In response to the first 

comment, the Medicare Marketing 

Guidelines for: Medicare Advantage 

Plans, Medicare Advantage Prescription 

Drug Plans, Prescription Drug Plan, 

1876 Cost Plans clarifies that upon 

request by the beneficiary, plans are 

permitted to schedule appointments 

with beneficiaries residing in long-term 

care facilities just as with other 

individuals living in a private residence. 

In response to the comments regarding 

marketing to patients that are 

hospitalized or receiving care in a 

dialysis center, these are areas where 

patients receive care primarily and 

therefore are prohibited areas. The 

preamble provides clarification on 

activities that can be permitted in 

common areas and activities that would 

be prohibited. Furthermore, the 

Medicare Marketing Guidelines for: 

Medicare Advantage Plans, Medicare 

Advantage Prescription Drug Plans, 

Prescription Drug Plan, 1876 Cost Plans 

also provide detail on the requirements 

for plan activities in a healthcare 

setting. 

Comment: One commenter 

recommended that CMS provide 

clarification as to whether providers 

could provide printed materials in 

waiting rooms regarding MA or Part D 

plans, which do not compare or contrast 

different health plans but focus instead 

on a single health plan. 

Response: The clarification is 

provided in the Medicare Marketing 

Guidelines for: Medicare Advantage 

Plans, Medicare Advantage Prescription 

Drug Plans, Prescription Drug Plan, 

1876 Cost Plans where it is stated that 

‘‘providers are permitted to make 

available and/or distribute plan 

marketing materials for all plans with 

which the provider participates.’’ 

Therefore, if a provider is only 

contracted with one health plan they are 

only obligated to display materials for 

that plan. Otherwise, the provider must 

display information from all plans with 

which the provider contracts. 

Comment: CMS received many 

comments on the prohibition on 

providing meals at marketing events, 

both in favor and opposed. Commenters 

in favor of the prohibition expressed 

that the inclusion of meals as a 

prohibited item would help protect 

beneficiaries by preventing mass 

enrollments without personal attention 

to the appropriateness of the plan. 

Comments opposed to the provision on 

meals were varied. Some stated it is 

overly restrictive, while others stated 

that there is no relationship between 

offering meals at an enrollment event 

and inappropriate sales tactics, and that 

meal settings can allow beneficiaries to 

feel more comfortable and less 

pressured than an in-home visit. 

Commenters stated that hosting meal 

events is a key marketing strategy, and 

the provision will have a significant 

impact on beneficiary attendance in 

marketing seminars. Several 

commenters stated that the current 

marketing guidance is sufficient. Some 

comments requested clarification on the 

term meals and the limitation—for 

example, is it acceptable if the 

beneficiary purchases their own meal or 

if a volunteer association arranges the 

meals, or if the meals are provided at an 

event where no enrollment forms are 

distributed or collected. One commenter 

stated that limiting food to snacks 

would be difficult to enforce. Several 

organizations made recommendations 

on different strategies of 

implementation, including the 

suggestions that organizations should be 

prohibited from advertising that a meal 

will be provided at a plan sponsored 

event, that meals be allowed at events 

where applications are not accepted, 

that a disclaimer be required that the 

meal is not a contingency for signing up 

for a plan, or that organizations should 

be prohibited from spending a dollar 

limit per person on all food and 

beverage items at a given event. 

Comments were received that this 

provision would deny restaurants an 

important source of revenue, and that 

beneficiaries also benefit from the 

opportunity to get free meals. 

Response: Based on oversight 

activities, we believe it is important to 

protect the integrity of the sales and 

marketing process by moving forward 

with this prohibition. Furthermore, 

MIPPA prohibits meals at marketing 

events. Therefore, we adopt the 

prohibition on meals as proposed. The 

Medicare Marketing Guidelines for: 

Medicare Advantage Plans, Medicare 

Advantage Prescription Drug Plans, 

Prescription Drug Plan, 1876 Cost Plans 

and other guidance will provide more 

detail on this requirement. As, noted, 

the issue of gifts will be addressed 

separately. 

Comment: One commenter argued 

that cross-selling of all non-Medicare 


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products should be prohibited, not just 

non-healthcare related products. In this 

commenter’s view, a prohibition on all 

non-Medicare products would ensure 

that beneficiaries focus on Medicare 

related products. Several commenters 

were in agreement with prohibiting the 

marketing of non-health care related 

products during a sale of Medicare 

Products, but similarly recommended 

that regulations governing cross-selling 

be expanded to bar the cross-selling of 

all non-Medicare related products. One 

commenter recommended that plans be 

permitted to cross sell health related 

items on inbound calls when a 

beneficiary has initiated the call. Some 

commenters requested clarification on 

what is considered health related 

products for the purposes of Medicare 

cross-selling requirements. A 

commenter believed that the agent 

oversight would be a huge 

administrative burden, and that the 

prohibition of cross selling would be 

inconvenient for potential members 

who are seeking to purchase other 

products. 

Response: We welcome the support 

for banning the marketing of non-health 

care related products. We are not 

changing this language to refer to nonMedicare related products however, for 

two reasons. First, non-Medicare health 

care coverage is subject to Medigap 

restrictions, and we would not expect 

MA organizations or PDP sponsors to 

attempt to sell non-Medicare health care 

products. Also, Congress has addressed 

the issue of cross-selling in a new 

section 1851(j)(2) that, effective January 

1, 2009, prohibits the sale of ‘‘nonhealth care related products (such as 

annuities and life insurance).’’ We 

believe that our final rule should track 

the statute in this area. 

F. Disclosure of Plan Information 

(§§ 422.111 and 423.128) 

We are finalizing our proposal in our 

May 16, 2008 proposed rule to specify 

in §§ 422.111(a)(3) and 423.128(a)(3) 

that plans must disclose the information 

specified in §§ 422.111(b) and 

423.128(b) of the MA and Part D 

program regulations, respectively, both 

at the time of enrollment and at least 

annually thereafter, 15 days before the 

annual coordinated election period. 

This is essential to ensuring that current 

enrollees receive comprehensive 

information necessary for making an 

informed decision regarding their health 

care options prior to the annual 

coordinated election period. Note that 

MIPPA made a related change affecting 

special needs plans disclosure 

requirements which we will discuss in 

a regulation to be published at or about 

the same time as this final rule. 

Comment: A commenter suggested 

that new enrollees receive 

comprehensive information about their 

benefit package prior to their purchase 

rather than after the sale. The 

commenter stated that more 

comprehensive information is essential 

for the consumer and the agent to know 

ahead of time in order to determine if 

a product is suitable for a particular 

individual. 

Response: We agree that disclosure of 

plan information continues to be an 

important feature that allows 

beneficiaries to make an informed 

decision about their healthcare options. 

MA plans and PDPs are obligated to 

provide details on benefits and rules 

prior to enrollment through preenrollment materials including the 

Summary of Benefits. The Summary of 

Benefits provides comparative 

information of Original Medicare and 

the benefits of the MA plan or PDP. We 

also believe that the Medicare & You 

Handbook along with other information 

channels such as the State Health 

Insurance Assistance Programs (SHIPs) 

and 1–800–MEDICARE provides an 

opportunity for Medicare beneficiaries 

to receive comprehensive information 

prior to enrollment on the choices 

available to them. Therefore, we will 

continue to allow plans the option of 

providing the Annual Notice of Change/ 

Evidence of Coverage (ANOC/EOC) 

prior to enrollment and upon 

beneficiary request. 

Comment: Several commenters 

suggested that CMS articulate penalties 

for plans that do not adhere to the 

disclosure requirement for the ANOC/ 

EOC, since there have been plans that 

have made these disclosures far too late 

in each of the past 3 years. 

Response: Pursuant to §§ 422.752(c) 

and 423.752(c), CMS may impose CMPs 

on an organization for any of the 

determinations at § 422.510(a) (except 

§§ 422.510(a)(4)) or 423.509(a) (except 

§ 423.509(a)(4)) if CMS determines that 

the organization’s conduct has adversely 

affected or has the substantial likelihood 

of adversely affecting one or more 

enrollees. Determinations that would 

justify the imposition of CMPs include 

the MA organization or Part D sponsor 

failing substantially to carry out the 

terms of its contract with CMS, the MA 

organization or Part D sponsor carrying 

out its contract with CMS in a manner 

that is inconsistent with the effective 

and efficient implementation of this 

part, and the MA organization 

substantially failing to comply with the 

marketing requirements at § 422.80 or 

the Part D sponsor substantially failing 

to comply with the dissemination of 

information requirements at § 423.128. 

Therefore, if CMS determines an 

organization’s failure to comply with 

marketing disclosure requirements 

supports a determination pursuant to 

§ 422.510(a) or § 423.509(a) and 

adversely affects or has the substantial 

likelihood of adversely affecting one or 

more enrollees, CMS may consider 

imposing a CMP. 

Comment: One commenter that 

supported the disclosure of plan 

information requested that CMS extend 

the proposal to require that plans 

disclose information 30 days before the 

annual coordinated election period. 

Response: We have reviewed this 

comment and we believe this provision 

will allow beneficiaries adequate time to 

make an informed decision about their 

health care options. Therefore, we will 

proceed with this provision in the final 

regulation without modification. 

Comment: One commenter stated 

thirty days prior to the benefit becoming 

effective is a more appropriate 

requirement with respect to employer 

groups, when the annual coordinated 

period is not specified. 

Response: Employer sponsored ‘‘800 

series’’ plans, Direct Contract plans or 

individual MA plans that are subject to 

Medicare marketing and disclosure 

requirements are subject to any 

applicable timing requirements for 

issuance of annual disclosure materials 

prior to the Annual Election Period 

(AEP). CMS has waived or modified 

applicable timing requirements in 

certain circumstances where a particular 

employer/union sponsor has an open 

enrollment period that differs from 

Medicare’s AEP. Under these 

circumstances, the timing for issuance 

of these materials would be based on the 

employer/union sponsor’s open 

enrollment period. In circumstances 

where there is no specified open 

enrollment period, CMS will clarify in 

the Medicare Managed Care Manual for 

Employer Groups and the Prescription 

Drug Benefits Manual for Employer 

Groups that disclosure materials based 

on the AEP must be received by 

beneficiaries no later than 15 days 

before the beginning of the plan year. 

IV. Provisions of the Final Regulations 

This final rule relocates to the new 

subpart V, sections from subparts B and 

C related to marketing definitions, 

marketing materials, and other 

marketing requirements: 

A. Definitions Concerning Marketing 

Materials (§§ 422.2260, 423.2260) 

We are making an organizational 

change for this section, consistent with 


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Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Rules and Regulations 54217 

our proposal to create a new subpart V 

of 42 CFR parts 422 and 423 specific to 

marketing. We are moving the definition 

of marketing materials to §§ 422.2260 

and 423.2260 of the Part C and D 

program regulations, respectively. 

B. Reviews and Distribution of 

Marketing Materials: File and Use 

(§§ 422.2262, 423.2262) 

• We are making an organizational 

change for this section, consistent with 

our proposal to create a new subpart V 

of 42 CFR parts 422 and 423 specific to 

marketing. We are moving §§ 422.80(a) 

and 423.50(a), which describe the 

review and distribution of marketing 

materials, to §§ 422.2264 and 423.2264, 

respectively, and making the language 

consistent between the two sections as 

423.50 was missing the provision now 

located at § 423.2264(a)(2)(i); allowing 

Part D sponsors to distribute their 

marketing materials 5 days following 

their submission to CMS provided the 

Part D sponsor is deemed to meet 

certain performance requirements 

established by CMS. In addition to 

moving these requirements to 

§§ 422.2262 and 423.2262 of the Part C 

and D program regulations, respectively, 

we proposed to modify the ‘‘file and 

use’’ review process. We are moving 

forward with our proposal to eliminate 

the file and use eligibility process. 

C. Guidelines for CMS (§§ 422.2264, 

423.2264) 

We are making an organizational 

change for this section, consistent with 

our proposal to create a new subpart V 

of 42 CFR parts 422 and 423 specific to 

marketing regulations. We are moving 

§§ 422.80(c) and 423.50(d), which 

describe specific guidelines for CMS 

review of marketing materials and 

election forms, to §§ 422.2264 and 

423.2264, respectively. 

D. Deemed Approval (§§ 422.2266, 

423.2266) 

Consistent with our proposal to create 

a new subpart V of 42 CFR parts 422 

and 423 specific to marketing 

regulations, we are making an 

organizational change for this section. 

We are removing §§ 422.80(d) and 

423.50(e) and adding §§ 422.2266 and 

423.2266, respectively. The provision 

concerns CMS’ deemed approval of the 

distribution of marketing materials. 

E. Standards for MA and PDP Marketing 

(§§ 422.2268, 423.2268) 

This final rule also incorporates six of 

the new provisions from the proposed 

rule and relocates several of the 

provisions that already existed in 

§§ 422.80 and 423.50. The remaining 

provisions from the May 2008 proposed 

rule will be incorporated into 

regulations that will be released later 

this year. There are four provisions of 

this final rule that differ from the May 

16, 2008, proposed rule: 

• Sections 422.2268(a) and 

423.2268(a) in the proposed rule have 

been modified by removing the 

sentence, ‘‘This does not prohibit 

explanation of any legitimate benefits 

the beneficiary might obtain as an 

enrollee of the MA plan, such as 

eligibility to enroll in a supplemental 

benefit plan that covers deductibles and 

coinsurance, or preventive services’’ 

and ‘‘This does not prohibit explanation 

of any legitimate benefits the beneficiary 

might obtain as an enrollee of the Part 

D plan,’’ respectively. This was done 

because each sentence creates ambiguity 

with respect to the prohibition against 

cash inducements in the respective first 

sentence of the provision. 

• Sections 422.2268(b) and 

423.2268(b) have been redesignated as 

§ 422.2268(p) and 423.2268(p), 

respectively. This modification 

separates the prohibition against 

providing meals to prospective enrollees 

at promotional and sales activities from 

the proposed nominal gifts provision. 

The nominal gifts provision will be 

addressed in a separate rule that 

implements the requirement that new 

MIPPA rules be in place no later than 

November 15, 2008. 

• Sections 422.2268(j) and 

423.2268(j) in the proposed rule have 

been revised in this final rule to be 

consistent with each other and with 

§ 423.50(f)(v) published in the April 15, 

2008, Policy and Technical Changes to 

the Medicare Prescription Drug Benefit 

final rule. 

• Sections 422.2268(k) and 

423.2268(k) in the proposed rule have 

been revised in this final rule to be 

consistent with the language in section 

103 of MIPPA. 

F. Licensing of Marketing 

Representatives and Confirmation of 

Marketing (§§ 422.2272, 423.2272) 

We are making an organizational 

change for this section, consistent with 

our proposal to create a new subpart V 

of 42 CFR 422 and 423 specific to 

marketing regulations. We are moving 

§§ 422.80(e)(2) and 423.50(f)(2), which 

describe standards of marketing, to 

§§ 422.2272 and 423.2272, respectively. 

We are adding §§ 422.2272(c) and 

423.2272(c) which require plans to 

appoint and use only State-licensed 

representatives to conduct direct 

marketing activities in accordance with 

State appointment laws. 

G. Employer Group Retiree Marketing 

(§§ 422.2276, 423.2276) 

We are making an organizational 

change for this section, consistent with 

our proposal to create a new subpart V 

of 42 CFR 422 and 423 specific to 

marketing regulations. We are moving 

§§ 422.80(f) to § 422.2276 and adding 

§ 423.2276, which describe 

requirements for employer group retiree 

marketing. 

H. Disclosure of Plan Information 

(§§ 422.111 and 423.128) 

We are finalizing our proposal in our 

May 16, 2008, proposed rule to specify 

in §§ 422.111(a)(3) and 423.128(a)(3) 

that plans must disclose the information 

specified in §§ 422.111(b) and 

423.128(b) of the MA and Part D 

program regulations, respectively, both 

at the time of enrollment and at least 

annually thereafter, 15 days before the 

annual coordinated election period. 

V. Waiver of 30-Day Delay in Effective 

Date 

Section 553(d) of the APA (5 U.S.C. 

section 553(d)) ordinarily requires a 30- 

day delay in the effective date of final 

rules after the date of their publication 

in the Federal Register. This 30-day 

delay in effective date can be waived, 

however, if an agency finds for good 

cause that the delay is impracticable, 

unnecessary, or contrary to the public 

interest, and the agency incorporates a 

statement of the finding and its reasons 

in the rule issued. 

In this case, we believe it is in the 

public interest to implement these 

provisions upon publication in order to 

be effective by October 1, 2008, when 

MA and PDP marketing season begins. 

Failure to implement these provisions 

prior to the beginning of the marketing 

season would hinder CMS’s ability to 

protect its beneficiaries by ensuring that 

they receive the necessary information 

to make informed choices during the 

annual election period. These 

provisions prevent agents and brokers 

from engaging in sales and marketing 

activities that may pressure 

beneficiaries to make plan choices for 

reasons other than those that best meet 

their health care needs. Without this 

waiver, these provisions would not be 

effective until January 1, 2009 as 

specified in MIPPA. 

VI. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

day notice in the Federal Register and 

solicit/public comment before a 

collection of information requirement is 

submitted to the Office of Management 


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and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We solicited public comment on each 

of these issues for the following sections 

of this document that contain 

information collection requirements: 

Section 422.2260 Definitions 

concerning marketing materials. 

Section 422.2260 defines the 

marketing materials that an MA 

organization must provide to Medicare 

beneficiaries. While there is burden 

associated with this requirement, we 

believe the burden associated with these 

requirements is exempt from the 

requirements of the Paperwork 

Reduction Act of 1995 (PRA) as defined 

in 5 CFR 1320.3(b)(2) because the time, 

effort, and financial resources necessary 

to comply with the requirement would 

be incurred by persons in the normal 

course of their activities. 

Section 422.2262 Review and 

distribution of marketing materials. 

Section 422.2262(a)(i) states that at 

least 45 days before the date of 

distribution the MA organization 

submits the material or form to CMS for 

review under guidelines in Section 

422.2264 of this Part. 

The burden associated with this is the 

time and effort put forth by the MA 

organization to submit the material to 

CMS for review. We estimate it would 

take one MA organization 720 minutes/ 

12 hours to comply with this 

requirement. We estimate 670 MA 

organizations would be affected 

annually by this requirement; therefore, 

the total annual burden associated with 

this requirement is 8,040 hours. The 

burden for this requirement is approved 

under OMB#: 0938–0753. 

This section also requires the MA 

organization to certify that in the case of 

these certain marketing materials 

designated by CMS, it followed all 

applicable marketing guidelines or used 

model language specified by CMS 

without modification. 

The burden associated with this 

requirement is the time and effort put 

forth by the MA organization to provide 

such certification. While there is burden 

associated with this requirement, we 

believe the burden associated with these 

requirements is exempt from the 

requirements of the Paperwork 

Reduction Act of 1995 (PRA). 

Section 422.2264 Guidelines for CMS 

review. 

Section 422.2264 states that in 

reviewing marketing material or election 

forms under § 422.2262 of this Part, 

CMS determines that the marketing 

materials (a) provide, in a format (and, 

where appropriate, print size), and 

using standard terminology that may be 

specified by CMS, the following 

information to Medicare beneficiaries 

interested in enrolling: 

(1) Adequate written description of 

rules (including any limitations on the 

providers from whom services can be 

obtained), procedures, basic benefits 

and services, and fees and other charges. 

(2) Adequate written description of 

any supplemental benefits and services. 

(3) Adequate written explanation of 

the grievance and appeals process, 

including differences between the two, 

and when it is appropriate to use each. 

(4) Any other information necessary 

to enable beneficiaries to make an 

informed decision about enrollment. 

(b) Notify the general Public of its 

enrollment period in an appropriate 

manner, through appropriate media, 

throughout its service and if applicable, 

continuation areas. 

(c) Includes in the written materials 

notice that the MA organization is 

authorized by law to refuse to renew its 

contract with CMS, that CMS also may 

refuse to renew the contract, and that 

termination or non-renewal may result 

in termination of the beneficiary’s 

enrollment in the plan. 

(d) Ensure that materials are not 

materially inaccurate or misleading or 

otherwise make material 

misrepresentations. 

(e) For markets with a significant nonEnglish speaking population, provide 

materials in the language of these 

individuals. 

The burden with these guidelines is 

the time and effort put forth by the MA 

organization to provide adequate 

written descriptions of rules, of any 

supplemental benefits and services, 

explanation of the grievance and 

appeals process, and any other 

information necessary to enable 

beneficiaries to make an informed 

decision about enrollment. It also 

requires the MA organization to notify 

the general public of its enrollment 

period in an appropriate manner and 

include in the written materials notice 

that the MA organization is authorized 

by law to refuse to renew its contract 

with CMS. While there is burden 

associated with this requirement, we 

believe the burden associated with these 

requirements is exempt from the 

requirements of the Paperwork 

Reduction Act of 1995 (PRA) as defined 

in 5 CFR 1320.3(b)(2) because the time, 

effort, and financial resources necessary 

to comply with the requirement would 

be incurred by persons in the normal 

course of their activities. 

Section 422.2272 Licensing of 

marketing representatives and 

confirmation of marketing resources. 

Section 422.2272(b) states that an MA 

organization must establish and 

maintain a system for confirming that 

enrolled beneficiaries have, in fact, 

enrolled in the MA plan and understand 

the rules applicable under the plan. 

The burden associated with this 

requirement is the time and effort put 

forth by the MA organization to 

establish and maintain such a system. 

While there is burden associated with 

this requirement, we feel the burden 

associated with these requirements is 

exempt from the requirements of the 

Paperwork Reduction Act of 1995 (PRA) 

as defined in 5 CFR 1320.3(b)(2) because 

the time, effort, and financial resources 

necessary to comply with the 

requirement would be incurred by 

persons in the normal course of their 

activities. 

Section 422.2276 Employer group 

retiree marketing. 

Section 422.2276 describes the 

development of marketing materials for 

employer group retiree marketing. 

While there is burden associated with 

this requirement, we believe the burden 

associated with these requirements is 

exempt from the requirements of the 

Paperwork Reduction Act of 1995 (PRA) 

as defined in 5 CFR 1320.3(b)(2) because 

the time, effort, and financial resources 

necessary to comply with the 

requirement would be incurred by 

persons in the normal course of their 

activities. 

Section 423.2260 Definitions 

concerning marketing materials. 

Section 423.2260 defines the 

marketing materials that a Part D 

Sponsor must provide to Medicare 

beneficiaries. While there is burden 

associated with this requirement, we 

believe the burden associated with these 

requirements is exempt from the 

requirements of the Paperwork 

Reduction Act of 1995 (PRA) as defined 

in 5 CFR 1320.3(b)(2) because the time, 

effort, and financial resources necessary 

to comply with the requirement would 

be incurred by persons in the normal 

course of their activities. 

Section 423.2262 Review and 

distribution of marketing materials. 


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Section 423.2262(a)(1)(i) requires the 

Part D sponsor to submit the marketing 

material or form to CMS for review 

under the guidelines in § 423.2264. 

The burden associated with these 

requirements is the time and effort put 

forth by the Part D sponsor to submit the 

marketing materials to CMS and to 

provide certification. We estimate it 

would take one Part D sponsor (720 

minutes/12 hours) to comply with this 

requirement. We estimate 87 Part D 

sponsors would be affected annually by 

this requirement; therefore, the total 

annual burden associated with this 

requirement is 1044 hours. The burden 

for this requirement is approved under 

OMB#: 0938–0964. 

Section 423.2264 Guidelines for CMS 

review. 

Section 423.2264 reads that in 

reviewing marketing material or 

enrollment forms under § 423.2262, 

CMS determines (unless otherwise 

specified in additional guidance) that 

the marketing materials (a) provide, in 

a format (and, where appropriate, print 

size), and using standard terminology 

that may be specified by CMS, the 

following information to Medicare 

beneficiaries interested in enrolling: 

(1) Adequate written description of 

rules (including any limitations on the 

providers from whom services can be 

obtained), procedures, basic benefits 

and services, and fees and other charges. 

(2) Adequate written explanation of 

the grievance and appeals process, 

including differences between the two, 

and when it is appropriate to use each. 

(3) Any other information necessary 

to enable beneficiaries to make an 

informed decision about enrollment. 

(b) Notify the general public of its 

enrollment period in an appropriate 

manner, through appropriate media, 

throughout its service area. 

(c) Include in the written materials 

notice that the Part D plan is authorized 

by law to refuse to renew its contract 

with CMS, that CMS also may refuse to 

renew the contract, and that termination 

or non-renewal may result in 

termination of the beneficiary’s 

enrollment in the Part D plan. In 

addition, the Part D plan may reduce its 

service area and no longer be offered in 

the area where a beneficiary resides. 

(d) Ensure that materials are not 

materially inaccurate or misleading or 

otherwise make material 

misrepresentations. 

(e) For markets with a significant nonEnglish speaking population, provide 

materials in the language of these 

individuals. 

The burden with these guidelines is 

the time and effort put forth by the Part 

D plan to provide adequate written 

descriptions of rules, of the grievance 

and appeals process, and any other 

information necessary to enable 

beneficiaries to make an informed 

decision about enrollment. It also 

requires the Part D plan to notify the 

general public of its enrollment period 

in an appropriate manner and include 

in the written materials notice that the 

Part D plan is authorized by law to 

refuse to renew its contract with CMS. 

While there is burden associated with 

this requirement, we believe the burden 

associated with these requirements is 

exempt from the requirements of the 

Paperwork Reduction Act of 1995 (PRA) 

as defined in 5 CFR 1320.3(b)(2) because 

the time, effort, and financial resources 

necessary to comply with the 

requirement would be incurred by 

persons in the normal course of their 

activities. 

Section 423.2272 Licensing of 

marketing representatives and 

confirmation of marketing resources. 

Section 423.2272(b) requires the Part 

D organization to establish and maintain 

a system for confirming that enrolled 

beneficiaries have in fact enrolled in the 

PDP and understand the rules 

applicable under the plan. 

The burden associated with this 

requirement is the time and effort put 

forth by the Part D sponsor to establish 

and maintain such a system. While 

there is burden associated with this 

requirement, we believe the burden 

associated with these requirements is 

exempt from the requirements of the 

Paperwork Reduction Act of 1995 (PRA) 

as defined in 5 CFR 1320.3(b)(2) because 

the time, effort, and financial resources 

necessary to comply with the 

requirement would be incurred by 

persons in the normal course of their 

activities. 

Section 423.2276 Employer group 

retiree marketing. 

Section 423.2276 describes the 

development of marketing materials for 

employer group retiree marketing. 

While there is burden associated with 

this requirement, we believe the burden 

associated with these requirements is 

exempt from the requirements of the 

Paperwork Reduction Act of 1995 (PRA) 

as defined in 5 CFR 1320.3(b)(2) because 

the time, effort, and financial resources 

necessary to comply with the 

requirement would be incurred by 

persons in the normal course of their 

activities. 

As reflected in the table that follows, 

the aggregate burden associated with the 

collection of information section of this 

final rule totals 9,084 hours. 

OMB No. Requirements Number of 

respondents Burden hours 

Total annual 

burden 

(hours) 

Exempt/None .................................................. 422.2260 ........................................................ N/A N/A N/A 

0938–0753 ...................................................... 422.2262(a)(i) ................................................. 670 12 8,040 

0938–0753 ...................................................... 422.2264 ........................................................ N/A N/A N/A 

0938–0753 ...................................................... 422.2272(b) .................................................... N/A N/A N/A 

Exempt/None .................................................. 423.2260 ........................................................ N/A N/A N/A 

0938–0964 ...................................................... 423.2262(a)(1)(i) ............................................ 87 12 1,044 

0938–0964 ...................................................... 423.2264 ........................................................ N/A N/A N/A 

0938–0964 ...................................................... 423.2272(b) .................................................... N/A N/A N/A 

Total Aggregate Burden .......................... ......................................................................... ........................ ........................ 9,084 

We have submitted a copy of this final 

rule to OMB for its review of the 

information collection requirements 

described above. 

VII. Regulatory Impact Statement 

We have examined the impact of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), Executive Order 13132 on 

Federalism, and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Order 12866 (as amended) 

directs agencies to assess all costs and 


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54220 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Rules and Regulations 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). 

The provisions of this final rule require 

plans to submit marketing materials to 

CMS for review. We estimate the total 

cost (MA and Part D programs) of these 

provisions as $197,295. As a result, this 

final rule does not reach this economic 

threshold and thus is not considered a 

major rule. 

We use the figure of $14.68 (based on 

the United States Department of Labor 

(DOL) (http://www.bls.gov/oes2006.htm) 

2006 BLS occupational employment 

statistics for the hourly wages of word 

processors and typists) plus the added 

OMB figures of 12 percent for overhead 

and 36 percent for benefits to represent 

average costs to plans, sponsors and 

downstream entities. (Note that the 

wages cited below include the hourly 

wage + an additional 48 percent to 

reflect overhead, benefit costs for total 

wages of $21.73). The costs for these 

provisions, in the context of each 

program, are as follows: 

• Submission of marketing materials, 

MA program ($21.73 × 8,040 hours = 

$174,709). 

• Submission of marketing materials, 

Part D program ($21.73 × 1,044 hours = 

$22,686). 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses, if a rule has a significant 

impact on a substantial number of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $6.5 million to $31.5 million in any 

1 year. Individuals and States are not 

included in the definition of a small 

entity. MA organizations and Part D 

sponsors, the only entities that will be 

affected by the final provisions, are not 

generally considered small business 

entities. Since they must follow 

minimum enrollment requirements 

(5,000 enrollees in urban areas and 

1,500 enrollees in non-urban areas), the 

revenue generated from enrollment 

generally exceeds the revenue threshold 

required for analysis. While a very small 

rural plan could fall below the 

threshold, we do not believe that there 

are more than a handful of such plans. 

A fraction of MA organizations and 

sponsors are considered small 

businesses because of their non-profit 

status. For an RFA analysis to be 

required, 3–5 percent of the identified 

small entities’ revenue would have to be 

impacted by the final provisions. We do 

not believe that any of these provisions 

meet this threshold. Many of the 

provisions, discussed in section II, 

Analysis of and Response to Public 

Comments, are clarifications of existing 

policy or require minimal costs. 

Therefore, because the rule will not 

have a significant economic impact on 

a substantial number of small entities, 

we are not preparing an analysis for the 

RFA. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 

of the Act because we have determined 

that this rule will not have a significant 

impact on the operations of a substantial 

number of small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year by State, local or tribal 

governments, in the aggregate, or by the 

private sector of $100 million in 1995 

dollars, updated annually for inflation. 

That threshold level is currently 

approximately $130 million. This rule 

will have no consequential effect on 

State, local, or tribal governments or on 

the private sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This rule will not have a substantial 

direct effect on State or local 

governments, preempt States, or 

otherwise have a Federalism 

implication. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects 

42 CFR Part 422 

Administrative practice and 

procedure, Health facilities, Health 

maintenance organizations (HMO), 

Medicare, Penalties, Privacy, Reporting 

and recordkeeping requirements. 

42 CFR Part 423 

Administrative practice and 

procedure, Emergency medical services, 

Health facilities, Health maintenance 

organizations (HMO), Medicare, 

Penalties, Privacy, Reporting and 

recordkeeping. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

chapter IV as set forth below: 

PART 422—MEDICARE ADVANTAGE 

PROGRAM 

■ 1. The authority citation for part 422 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart B—Eligibility, Election, and 

Enrollment 

§ 422.80 [Removed] 

■ 2. Remove § 422.80. 

Subpart C—Benefits and Beneficiary 

Protections 

■ 3. Amend § 422.111 by revising 

paragraph (a)(3) to read as follows: 

§ 422.111 Disclosure requirements 

* * * * * 

(a) * * * 

(3) At the time of enrollment and at 

least annually thereafter, 15 days before 

the annual coordinated election period. 

* * * * * 

■ 4. New subpart V is added to read as 

follows: 

Subpart V—Medicare Advantage Marketing 

Requirements 

Sec. 

422.2260 Definitions concerning marketing 

materials. 

422.2262 Review and distribution of 

marketing materials. 

422.2264 Guidelines for CMS review. 

422.2266 Deemed approval. 

422.2268 Standards for MA organization 

marketing. 

422.2272 Licensing of marketing 

representatives and confirmation of 

marketing resources. 

422.2274 [Reserved] 

422.2276 Employer group retiree marketing. 


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Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Rules and Regulations 54221 

Subpart V—Medicare Advantage 

Marketing Requirements 

§ 422.2260 Definitions concerning 

marketing materials. 

As used in this subpart— 

Marketing materials. Marketing 

materials include any informational 

materials targeted to Medicare 

beneficiaries which: 

(1) Promote the MA organization, or 

any MA plan offered by the MA 

organization. 

(2) Inform Medicare beneficiaries that 

they may enroll, or remain enrolled in, 

an MA plan offered by the MA 

organization. 

(3) Explain the benefits of enrollment 

in an MA plan, or rules that apply to 

enrollees. 

(4) Explain how Medicare services are 

covered under an MA plan, including 

conditions that apply to such coverage. 

(5) May include, but are not limited 

to, the following: 

(i) General audience materials such as 

general circulation brochures, 

newspapers, magazines, television, 

radio, billboards, yellow pages, or the 

Internet. 

(ii) Marketing representative materials 

such as scripts or outlines for 

telemarketing or other presentations. 

(iii) Presentation materials such as 

slides and charts. 

(iv) Promotional materials such as 

brochures or leaflets, including 

materials for circulation by third parties 

(for example, physicians or other 

providers). 

(v) Membership communication 

materials such as membership rules, 

subscriber agreements, member 

handbooks and wallet card instructions 

to enrollees. 

(vi) Letters to members about 

contractual changes; changes in 

providers, premiums, benefits, plan 

procedures etc. 

(vii) Membership or claims processing 

activities (for example, materials on 

rules involving non-payment of 

premiums, confirmation of enrollment 

or disenrollment, or annual notification 

information). 

§ 422.2262 Review and distribution of 

marketing materials. 

(a) CMS review of marketing 

materials. (1) Except as provided in 

paragraph (b) of this section, an MA 

organization may not distribute any 

marketing materials (as defined in 

§ 422.2260 of this part), or election 

forms, or make such materials or forms 

available to individuals eligible to elect 

an MA organization unless— 

(i) At least 45 days (or 10 days if using 

marketing materials that use, without 

modification, proposed model language 

as specified by CMS) before the date of 

distribution the MA organization has 

submitted the material or form to CMS 

for review under the guidelines in 

§ 422.2264 of this Part; and 

(ii) CMS does not disapprove the 

distribution of new material or form. 

(2) [Reserved] 

(b) File and use. The MA organization 

may distribute certain types of 

marketing materials, designated by 

CMS, 5 days following their submission 

to CMS if the MA organization certifies 

that in the case of these designated 

marketing materials, it followed all 

applicable marketing guidelines and, 

when applicable, used model language 

specified by CMS without modification. 

§ 422.2264 Guidelines for CMS review. 

In reviewing marketing material or 

election forms under § 422.2262 of this 

part, CMS determines that the marketing 

materials— 

(a) Provide, in a format (and, where 

appropriate, print size), and using 

standard terminology that may be 

specified by CMS, the following 

information to Medicare beneficiaries 

interested in enrolling: 

(1) Adequate written description of 

rules (including any limitations on the 

providers from whom services can be 

obtained), procedures, basic benefits 

and services, and fees and other charges; 

(2) Adequate written description of 

any supplemental benefits and services; 

(3) Adequate written explanation of 

the grievance and appeals process, 

including differences between the two, 

and when it is appropriate to use each; 

and 

(4) Any other information necessary 

to enable beneficiaries to make an 

informed decision about enrollment. 

(b) Notify the general public of its 

enrollment period in an appropriate 

manner, through appropriate media, 

throughout its service area and if 

applicable, continuation areas. 

(c) Include in written materials notice 

that the MA organization is authorized 

by law to refuse to renew its contract 

with CMS, that CMS also may refuse to 

renew the contract, and that termination 

or non-renewal may result in 

termination of the beneficiary’s 

enrollment in the plan. 

(d) Ensure that materials are not 

materially inaccurate or misleading or 

otherwise make material 

misrepresentations. 

(e) For markets with a significant nonEnglish speaking population, provide 

materials in the language of these 

individuals. 

§ 422.2266 Deemed approval. 

If CMS has not disapproved the 

distribution of marketing materials or 

forms submitted by an MA organization 

with respect to an MA plan in an area, 

CMS is deemed not to have disapproved 

the distribution in all other areas 

covered by the MA plan and 

organization except with regard to any 

portion of the material or form that is 

specific to the particular area. 

§ 422.2268 Standards for MA organization 

marketing. 

In conducting marketing activities, 

MA organizations may not— 

(a) Provide cash or other monetary 

rebates as an inducement for enrollment 

or otherwise. 

(b) [Reserved] 

(c) Engage in any discriminatory 

activity such as, for example, attempts 

to recruit Medicare beneficiaries from 

higher income areas without making 

comparable efforts to enroll Medicare 

beneficiaries from lower income areas. 

(d) Solicit door-to-door for Medicare 

beneficiaries or through other 

unsolicited means of direct contact, 

including calling a beneficiary without 

the beneficiary initiating the contact. 

(e) Engage in activities that could 

mislead or confuse Medicare 

beneficiaries, or misrepresent the MA 

organization. The MA organization may 

not claim it is recommended or 

endorsed by CMS or Medicare or that 

CMS or Medicare recommends that the 

beneficiary enroll in the MA plan. It 

may, however, explain that the 

organization is approved for 

participation in Medicare. 

(f) Market non-health care related 

products to prospective enrollees during 

any MA or Part D sales activity or 

presentation. This is considered crossselling and is prohibited. 

(g) [Reserved] 

(h) [Reserved] 

(i) Distribute marketing materials for 

which, before expiration of the 45-day 

period, the MA organization receives 

from CMS written notice of disapproval 

because it is inaccurate or misleading, 

or misrepresents the MA organization, 

its marketing representatives, or CMS. 

(j) Use providers or provider groups to 

distribute printed information 

comparing the benefits of different 

health plans unless the providers, 

provider groups, or pharmacies accept 

and display materials from all health 

plans with which the providers, 

provider groups, or pharmacies contract. 

The use of publicly available 

comparison information is permitted if 

approved by CMS in accordance with 

the Medicare marketing guidance. 

(k) Conduct sales presentations or 

distribute and accept MA plan 


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54222 Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Rules and Regulations 

enrollment forms in provider offices or 

other areas where health care is 

delivered to individuals, except in the 

case where such activities are 

conducted in common areas in health 

care settings. 

(l) Conduct sales presentations or 

distribute and accept plan applications 

at educational events. 

(m) Employ MA plan names that 

suggest that a plan is not available to all 

Medicare beneficiaries. This prohibition 

shall not apply to MA plan names in 

effect on July 31, 2000. 

(n) [Reserved] 

(o) Engage in any other marketing 

activity prohibited by CMS in its 

marketing guidance. 

(p) Provide meals for potential 

enrollees, which is prohibited, 

regardless of value. 

(q) [Reserved] 

§ 422.2272 Licensing of marketing 

representatives and confirmation of 

marketing resources. 

In its marketing, the MA organization 

must: 

(a) Demonstrate to CMS’ satisfaction 

that marketing resources are allocated to 

marketing to the disabled Medicare 

population as well as beneficiaries age 

65 and over. 

(b) Establish and maintain a system 

for confirming that enrolled 

beneficiaries have, in fact, enrolled in 

the MA plan, and understand the rules 

applicable under the plan. 

(c) Employ as marketing 

representatives only individuals who 

are licensed by the State to conduct 

marketing activities (as defined in the 

Medicare Marketing Guidelines) in that 

State, and whom the organization has 

informed that State it has appointed, 

consistent with the appointment process 

provided for under State law. 

§ 422.2274 [Reserved] 

§ 422.2276 Employer group retiree 

marketing. 

MA organizations may develop 

marketing materials designed for 

members of an employer group who are 

eligible for employer-sponsored benefits 

through the MA organization, and 

furnish these materials only to the group 

members. These materials are not 

subject to CMS prior review and 

approval. 

PART 423—VOLUNTARY MEDICARE 

PRESCRIPTION DRUG BENEFIT 

■ 5. The authority citation for part 423 

continues to read as follows: 

Authority: Secs. 1102, 1860D–1 through 

1860D–42, and 1871 of the Social Security 

Act (42 U.S.C. 1302, 1395w–101 through 

1395w–152, and 1395hh). 

Subpart B—Eligibility, Election, and 

Enrollment 

§ 423.50 [Removed] 

■ 6. Remove § 423.50. 

Subpart C—Benefits and Beneficiary 

Protections 

■ 7. Amend § 423.128 by revising 

paragraph (a)(3) to read as follows: 

§ 423.128 Dissemination of Part D Plan 

Information. 

(a) * * * 

(3) At the time of enrollment and at 

least annually thereafter, 15 days before 

the annual coordinated election period. 

■ 8. Add new subpart V to read as 

follows: 

Subpart V—Part D Marketing Requirements 

Sec. 

423.2260 Definitions concerning marketing 

materials. 

423.2262 Review and distribution of 

marketing materials. 

423.2264 Guidelines for CMS review. 

423.2266 Deemed approval. 

423.2268 Standards for Part D marketing. 

423.2272 Licensing of marketing 

representatives and confirmation of 

marketing resources. 

423.2274 [Reserved] 

423.2276 Employer group retiree marketing. 

Subpart V—Part D Marketing 

Requirements 

§ 423.2260 Definitions concerning 

marketing materials. 

As used in this subpart— 

Marketing Materials. Marketing 

Materials include any informational 

materials targeted to Medicare 

beneficiaries which— 

(1) Promote the Part D plan. 

(2) Inform Medicare beneficiaries that 

they may enroll, or remain enrolled in 

a Part D plan. 

(3) Explain the benefits of enrollment 

in a Part D plan, or rules that apply to 

enrollees. 

(4) Explain how Medicare services are 

covered under a Part D plan, including 

conditions that apply to such coverage. 

(5) May include, but are not limited 

to— 

(i) General audience materials such as 

general circulation brochures, 

newspapers, magazines, television, 

radio, billboards, yellow pages, or the 

Internet. 

(ii) Marketing representative materials 

such as scripts or outlines for 

telemarketing or other presentations. 

(iii) Presentation materials such as 

slides and charts. 

(iv) Promotional materials such as 

brochures or leaflets, including 

materials for circulation by third parties 

(for example, physicians or other 

providers). 

(v) Membership communication 

materials such as membership rules, 

subscriber agreements, member 

handbooks and wallet card instructions 

to enrollees. 

(vi) Letters to members about 

contractual changes; changes in 

providers, premiums, benefits, plan 

procedures etc. 

(vii) Membership or claims processing 

activities. 

§ 423.2262 Review and distribution of 

marketing materials. 

(a) CMS review of marketing 

materials. (1) Except as provided in 

paragraph (a)(2) of this section, a Part D 

plan may not distribute any marketing 

materials (as defined in § 423.2260 of 

this Part), or enrollment forms, or make 

such materials or forms available to Part 

D eligible individuals unless— 

(i) At least 45 days (or 10 days if using 

certain types of marketing materials that 

use, without modification, proposed 

model language as specified by CMS) 

before the date of distribution, the Part 

D sponsor submits the material or form 

to CMS for review under the guidelines 

in § 423.2264; and 

(ii) CMS does not disapprove the 

distribution of new material or form. 

(2) [Reserved] 

(b) File and use. The Part D sponsor 

may distribute certain types of 

marketing material, designated by CMS, 

5 days following their submission to 

CMS if the Part D sponsor certifies that 

in the case of these marketing materials, 

it followed all applicable marketing 

guidelines and, when applicable, used 

model language specified by CMS 

without modification. 

§ 423.2264 Guidelines for CMS review. 

In reviewing marketing material or 

enrollment forms under § 423.2262, 

CMS determines (unless otherwise 

specified in additional guidance) that 

the marketing materials— 

(a) Provide, in a format (and, where 

appropriate, print size), and using 

standard terminology that may be 

specified by CMS, the following 

information to Medicare beneficiaries 

interested in enrolling: 

(1) Adequate written description of 

rules (including any limitations on the 

providers from whom services can be 

obtained), procedures, basic benefits 

and services, and fees and other charges; 

(2) Adequate written explanation of 

the grievance and appeals process, 

including differences between the two, 

and when it is appropriate to use each; 

and 

(3) Any other information necessary 

to enable beneficiaries to make an 

informed decision about enrollment. 


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Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Rules and Regulations 54223 

(b) Notify the general public of its 

enrollment period in an appropriate 

manner, through appropriate media, 

throughout its service area. 

(c) Include in the written materials 

notice that the Part D plan is authorized 

by law to refuse to renew its contract 

with CMS, that CMS also may refuse to 

renew the contract, and that termination 

or non-renewal may result in 

termination of the beneficiary’s 

enrollment in the Part D plan. In 

addition, the Part D plan may reduce its 

service area and no longer be offered in 

the area where a beneficiary resides. 

(d) Ensure that materials are not 

materially inaccurate or misleading or 

otherwise make material 

misrepresentations. 

(e) For markets with a significant nonEnglish speaking population, provide 

materials in the language of these 

individuals. 

§ 423.2266 Deemed approval. 

If CMS has not disapproved the 

distribution of marketing materials or 

forms submitted by a Part D sponsor for 

a Part D plan in a Part D region, CMS 

is deemed to not have disapproved the 

distribution of the marketing material or 

form in all other Part D regions covered 

by the Part D plan, with the exception 

of any portion of the material or form 

that is specific to the Part D region. 

§ 423.2268 Standards for Part D marketing. 

In conducting marketing activities, a 

Part D plan may not— 

(a) Provide cash or other 

remuneration as an inducement for 

enrollment or otherwise. 

(b) [Reserved] 

(c) Engage in any discriminatory 

activity such as, for example, attempts 

to recruit Medicare beneficiaries from 

higher income areas without making 

comparable efforts to enroll Medicare 

beneficiaries from lower income areas. 

(d) Solicit door-to-door for Medicare 

beneficiaries or through other 

unsolicited means of direct contact, 

including calling a beneficiary without 

the beneficiary initiating the contact. 

(e) Engage in activities that could 

mislead or confuse Medicare 

beneficiaries, or misrepresent the Part D 

sponsor or its Part D plan. The Part D 

organization may not claim that it is 

recommended or endorsed by CMS or 

Medicare or that CMS or Medicare 

recommends that the beneficiary enroll 

in the Part D plan. The Part D 

organization may explain that the 

organization is approved for 

participation in Medicare. 

(f) Market non-health care related 

products to prospective enrollees during 

any MA or Part D sales activity or 

presentation. This is considered crossselling and is prohibited. 

(g) [Reserved] 

(h) [Reserved] 

(i) Distribute marketing materials for 

which, before expiration of the 45-day 

period, the PDP Sponsor receives from 

CMS written notice of disapproval 

because it is inaccurate or misleading, 

or misrepresents the PDP Sponsor, its 

marketing representatives, or CMS. 

(j) Use providers, provider groups, or 

pharmacies to distribute printed 

information for beneficiaries to use 

when comparing the benefits of 

different Part D plans unless providers, 

provider groups or pharmacies accept 

and display materials from all Part D 

plan sponsors with which the providers, 

provider groups or pharmacies contract. 

The use of publicly available 

comparison information is permitted if 

approved by CMS in accordance with 

the Medicare marketing guidelines. 

(k) Conduct sales presentations or 

distribute and accept Part D plan 

enrollment forms in provider offices, 

pharmacies or other areas where health 

care is delivered to individuals, except 

in the case where such activities are 

conducted in common areas in health 

care settings. 

(l) Conduct sales presentations or 

distribute and accept plan applications 

at educational events. 

(m) Employ Part D plan names that 

suggest that a plan is not available to all 

Medicare beneficiaries. 

(n) [Reserved] 

(o) Engage in any other marketing 

activity prohibited by CMS in its 

marketing guidance. 

(p) Provide meals for potential 

enrollees, which are prohibited, 

regardless of value. 

(q) [Reserved] 

§ 423.2272 Licensing of marketing 

representatives and confirmation of 

marketing resources. 

In its marketing, the Part D 

organization must— 

(a) Demonstrate to CMS’s satisfaction 

that marketing resources are allocated to 

marketing to the disabled Medicare 

population as well as beneficiaries age 

65 and over. 

(b) Establish and maintain a system 

for confirming that enrolled 

beneficiaries have in fact enrolled in the 

PDP and understand the rules 

applicable under the plan. 

(c) Employ as marketing 

representatives only individuals who 

are licensed by the State to conduct 

direct marketing activities (as defined in 

the Medicare Marketing Guidelines) in 

that State, and whom the sponsor has 

informed that State it has appointed, 

consistent with the appointment process 

provided for under State law. 

§ 423.2274 [Reserved] 

§ 423.2276 Employer group retiree 

marketing. 

Part D sponsors may develop 

marketing materials designed for 

members of an employer group who are 

eligible for employer-sponsored benefits 

through the Part D sponsor, and furnish 

these materials only to the group 

members. These materials are not 

subject to CMS prior review and 

approval. 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.778, Medical 

Assistance Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 19, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: August 27, 2008. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E8–21674 Filed 9–15–08; 9:00 am] 

BILLING CODE 4120–01–P 


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