Medicare Program; Medicare Prescription Drug Discount Card; Revision of Marketing Rules for Endorsed Drug Card Sponsors, 52019-52023 [05-17424]
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Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Rules and Regulations
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[FR Doc. 05–17435 Filed 8–31–05; 8:45 am]
BILLING CODE 6560–50–P
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RIN 0938–AN97
Medicare Program; Medicare
Prescription Drug Discount Card;
Revision of Marketing Rules for
Endorsed Drug Card Sponsors
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
SUMMARY: This final rule will revise the
current limitations prohibiting an
endorsed drug card sponsor from
marketing its Part D plans to its drug
card enrollees. This revised rule will
give the current drug card sponsors the
ability to market to their enrollees Part
D plans that are either offered by the
same endorsed drug card sponsor or an
affiliated organization of the same
endorsed drug card sponsor. We are
making these changes after considering
the public comments received regarding
the need to ensure a smooth transition
from the drug card to the Medicare
Prescription Drug Benefit.
DATES: Effective Date: These regulations
are effective on October 1, 2005.
FOR FURTHER INFORMATION CONTACT:
Jennifer Shapiro, (410) 786–7407.
SUPPLEMENTARY INFORMATION:
Availability of Final Rule
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of this document may be downloaded
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• https://www.gpoaccess.gpo/nara/
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I. Background
The Medicare drug discount card
program was established by section 101,
subpart 4, of the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 and is codified in section
1860D–31 of the Social Security Act (the
‘‘Act’’). On December 15, 2003, in
accordance with section 105(c)(1)(C) of
the Act, we published the interim final
rule with comment period (hereafter
referred to as ‘‘interim final rule’’) for
the Medicare drug discount card
program on December 15, 2003 (68 FR
69840).
The interim final rule at § 403.813(a)
addresses marketing limitations
applicable to endorsed discount card
sponsors in accordance with section
1860D–31(h)(7)(B) of the Act. Under
these marketing limitations, an
endorsed sponsor may only market
those products and services offered
under its endorsed program that are
inside the scope of endorsement and
permitted under the HIPAA Privacy
Rule.
After considering the public
comments on these issues we agree with
the commenters that this policy does
not comply with the intent of the
Medicare Modernization Act which
directs the Secretary to facilitate
efficient enrollment into Part D plans.
This final rule allows an endorsed card
sponsor to market information to its
Medicare drug card enrollees
concerning its Part D plans offered by
the endorsed card sponsor or an
affiliated organization. This change will
increase Medicare beneficiaries’
awareness and knowledge of Part D
plans, thereby facilitating a smooth
transition from the Medicare
Prescription Drug Discount Card
Program to the Medicare Prescription
Drug Benefit.
Requirements for Issuance of
Regulations
Section 902 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA)
amended section 1871(a) of the Act and
requires, in part, that the Secretary, in
consultation with the Director of the
Office of Management and Budget
establish and publish timelines for the
publication of Medicare final
regulations based on the previous
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Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Rules and Regulations
publication of a Medicare proposed or
interim final regulation. Section
902(a)(1) of the MMA also states that the
timelines for these regulations may vary
but shall not exceed 3 years after
publication of the preceding proposed
or interim final regulation except under
exceptional circumstances.
Therefore, we believe that the final
rule is in accordance with the
Congress’s intent to ensure timely
publication of final regulations.
II. Discussion of the Provisions of the
Final Rule
A. Provision of the Interim Final Rule
Section 403.813(a)(1) of the December
15, 2003 interim final rule provides that
an endorsed sponsor may only market
those products and services offered
under its endorsed program that are
inside the scope of endorsement as
defined in § 403.806(h) and permitted
under § 403.812(b) (pertaining to the
HIPAA privacy requirements). Section
403.806(h)(2) defines products and
services inside the scope of the
Medicare endorsement as products and
services that are: (1) Directly related to
covered discount card drugs or
discounts for over-the-counter drugs;
and (2) offered for no additional fee
(other than the enrollment fee).
Section 403.813(a) of the interim final
rule provides that an endorsed sponsor
may not request that a drug card
enrollee or an individual seeking to
enroll in its endorsed discount card
program authorize the endorsed sponsor
to use or disclose individually
identifiable health information for
marketing other products or services not
otherwise allowed under § 403.813(a)(1)
(§ 403.813(a)(2)); that an endorsed
sponsor may not commingle any
materials related to the marketing of
products or services allowed under
§ 403.813(a)(1) with other marketing
materials (§ 403.813(a)(3)); and that
following termination of an endorsed
sponsor’s endorsement under
§ 403.820(c), (d) or (e) or termination of
the Medicare Drug Discount Card and
Transitional Assistance Program, a drug
card enrollee’s individually identifiable
health information collected or
maintained by an endorsed sponsor may
not be used or disclosed for purposes of
marketing any product or service
(§ 403.813(a)(4)).
These provisions on marketing
limitations are based on section 1860D–
31(h)(7)(B) of the Act, which states that
an endorsed sponsor may market a
product or service under the program
only if the product or service is directly
related to a covered discount card drug
or a discount price for a non-
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prescription drug, and on section
1860D–31(h)(8) of the Act, which
charges us with protecting and
promoting the interests of discount card
eligible individuals.
In addition to the specific
requirements of the Act that the product
or services be directly related to a
covered discount card drug or a
discount on a non-prescription drug,
§ 403.806(h)(2) of the interim final
regulation further requires that products
and services inside the scope of
endorsement are limited to products or
services offered for no additional charge
because, as we stated in the preamble,
we were concerned that beneficiaries
would be unable to access negotiated
prices and transitional assistance, as
intended by the Congress, if endorsed
sponsors required that they pay
additional fees for optional products
and services. Further, we believed that
permitting endorsed sponsors to charge
additional fees could be confusing to
beneficiaries. Also, if we were to allow
endorsed sponsors to charge additional
fees, we believe beneficiaries might, in
effect, be charged annual enrollment
fees higher than the $30 limit mandated
by section 1860D–31(c)(2)(B) of the Act,
especially if endorsed sponsors were to
condition enrollment in their endorsed
programs on beneficiaries paying these
additional fees.
III. Analysis of and Response to Public
Comments
A. Overview of Comments
We received 49 public comments
concerning the Medicare drug discount
card program. Of these comments, 8
timely comments were received that
addressed issues on marketing and
information and outreach in two
separate areas. A summary of the major
issues and our responses are as follows:
Comment: Of the 8 comments related
to marketing, 4 of the comments
expressed the need to minimize the
potential for beneficiary confusion and
encouraged us to allow sponsors to
provide enrollees with valuable health
education and other information. One
commenter encouraged us to ensure that
the regulation reflect the intent of the
conferees that there be a seamless
transition between the drug card
program and the Medicare Prescription
Drug Benefit. The other commenters
encouraged us to create guidelines
concerning marketing materials and
fairness in marketing. None of the
comments were opposed to us issuing
additional guidelines.
Response: We agree with the
commenters’ concerns regarding the
need to minimize beneficiary confusion
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by allowing endorsed sponsors to
distribute certain important and
valuable information to beneficiaries,
including information which will
promote a smoother transition for drug
card enrollees from the Medicareapproved prescription drug discount
card program to the Medicare
Prescription Drug Benefit. The Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 Conference
Report clearly articulates this intent
where the report discusses the history of
the drug card program and its original
purpose as an interim step toward
prescription drug coverage for Medicare
beneficiaries. Furthermore, a separate
discussion appearing in the Conference
Report addressing Part D emphasizes
the need to facilitate outreach to
beneficiaries to ensure participation in
Medicare prescription drug coverage
and to reduce barriers associated with
marketing to minimize the potential for
confusion and to facilitate enrollment
into the Medicare Prescription Drug
Benefit.
We agree with the commenter that
encouraged us to ensure that the
regulation reflect the intent of the
conferees that there be a seamless
transition between the drug card
program and the Medicare Prescription
Drug Benefit. As we move toward
implementation of the Medicare
Prescription Drug Benefit, it has become
evident that certain aspects of the
interim final rule are creating
unintended consequences for Medicare
beneficiaries and endorsed card
sponsors. Specifically the marketing
limitations at § 403.813(a) contradict
Congressional intent for the Medicare
prescription drug discount card program
to serve as a transitional program to the
Medicare Prescription Drug Benefit. As
previously mentioned, the provisions in
the interim final rule prevent an
endorsed drug card sponsor from
marketing its Part D plans to its drug
card enrollees. Moreover, we agree that
clarifications and modifications to the
marketing limitation rules would reduce
beneficiary confusion as the drug card
program concludes and the Medicare
Prescription Drug Benefit begins.
Finally, it is crucial that Medicare
beneficiaries have complete and
accurate information on the forthcoming
Medicare Prescription Drug Benefit. We
agree with all comments that expressed
an important aspect of ensuring that
beneficiaries receive this information is
by allowing a beneficiary’s drug card
sponsor, an entity with which the
beneficiary is familiar and has an
existing relationship to provide
educational and related information
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about the transition to the Medicare
prescription drug benefit and the Part D
plans that will be offered by the
endorsed sponsor or its affiliated
organizations. Allowing endorsed
sponsors to provide information to their
members about certain Part D plans
available to them is a component of the
Secretary’s strategy for meeting his
obligation under sections 1851(d)(1) and
1860D–1(c) of the Act to promote an
active, informed selection by
beneficiaries among their Medicare
coverage options.
As a result, this final rule amends
§ 403.813(a)(1) to allow an endorsed
card sponsor to market to its drug card
enrollees not only items and products
offered within the scope of
endorsement, but also Part D plans
offered by the endorsed sponsor or an
affiliated organization of the endorsed
sponsor.
Section 1860D–31(h)(7)(B) of the Act
provides that endorsed sponsors may
only market products or services ‘‘under
the program’’ if they directly relate to
either a covered discount card drug or
discount prices available for over-thecounter drugs. We believe products or
services marketed ‘‘under the program’’
include not only those within the scope
of endorsement, but also Part D plans.
Because information about Part D plans
offered by an endorsed sponsor or its
affiliated organizations would reinforce
the purpose of the Medicare
prescription drug discount card program
to serve as a transitional program to the
Medicare prescription drug benefit, we
believe marketing of such Part D plans
constitutes marketing of a product or
service under the Medicare prescription
drug discount card program. In
addition, we believe Part D plans are
directly related to covered discount card
drugs, as evidenced by the fact that the
statutory definition of a covered drug
under section 1860D–31(a)(4)(a) of the
Act cross-references the definition of
covered Part D drug under section
1860D–2(e) of the Act, and thus is
identical to the definition of covered
Part D drug.
Therefore, we amend the marketing
limitations in § 403.813(a)(1) by
explicitly stating that Part D plans
offered by an endorsed sponsor or its
affiliated organization may be directly
marketed by the endorsed sponsor to its
enrollees. We will not otherwise change
the marketing limitation provisions of
the interim final rule because we
maintain that section 1860D–31(h)(8) of
the Act charges us with protecting and
promoting the interests of Medicare
beneficiaries who may be unable to
access negotiated prices and transitional
assistance, as intended by the Congress,
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if endorsed sponsors require that they
pay additional fees for optional
products and services, such as Part B
supplies. Furthermore, permitting
endorsed sponsors to charge additional
fees for products and services outside
the scope of the endorsement could be
confusing to beneficiaries. Also, if we
were to allow endorsed sponsors to
charge additional fees, we believe
beneficiaries might, in effect, be charged
annual enrollment fees higher than the
$30 limit mandated by section 1860D–
31(c)(2)(B) of the Act, especially if
endorsed sponsors were to condition
enrollment in their endorsed programs
on beneficiaries paying these additional
fees. The amendment to allow
marketing of Part D plans makes sense
in this instance because in this context
it does not negate the intent or practice
of the original restriction (for example,
regarding Part B supplies). We believe
that this amendment is consistent with
the intent of the Congress, which would
reduce confusion and facilitate a smooth
transition to the Medicare Prescription
Drug Benefit which protects and
promotes interests of all Medicare
beneficiaries. Also, this exception will
not affect the enrollment fee.
We will require information and
outreach (marketing) materials
discussing Part D plans that are
disseminated by endorsed drug card
sponsors or their affiliated organizations
to the endorsed sponsors’ drug card
enrollees to be approved through the
Medicare Prescription Drug Benefit
review process as described under
§ 423.50 as opposed to the drug card
review process. This change addresses
comments that CMS should create
guidelines concerning marketing
materials and fairness in marketing, and
comments that we should endeavor to
reduce beneficiary confusion. Using a
single review process, with consistent
guidelines specifically developed for
Part D materials, is the optimal process
for ensuring adherence to guidelines
and reducing beneficiary confusion.
Therefore, we are amending
§ 403.806(g)(5) to state that all materials
related to Part D plans being offered by
the same endorsed sponsor or its
affiliated organization must comply
with the requirements described in
§ 423.50.
We are cognizant that constraints and
clarifications must be made about
whose products an endorsed card
sponsor may provide marketing
materials about to its drug card
enrollees. An endorsed drug card
sponsor may market a Part D plan
offered by it or its affiliated
organization. By allowing an endorsed
card sponsor to market Part D plans
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52021
offered by an affiliated organization of
the endorsed sponsor, we are treating
Part D plans offered by an affiliated
organization of the endorsed sponsor as
a product or service under the program.
Allowing such treatment gives practical
effect to the Congressional intent of a
smooth transition between the drug card
program and the Medicare Prescription
Drug Benefit because it recognizes that
rather than offer Part D plans through
the same legal entity, organizations may
have legitimate business and legal
reasons for offering Part D plans through
another legal entity, or may offer Part D
plans through different legal entities
based on geography (for example, Part D
plans in region A offered through legal
entity A, Part D plans in region B
offered through legal entity B). We do
not want to constrain an organization’s
ability to offer its Part D plans through
the legal entities that make the most
sense given other business and legal
considerations. A Part D Plan is not
offered under the program, however, if
the plan is offered by an organization
that is not the endorsed sponsor or an
affiliated organization of the endorsed
sponsor.
Therefore, we are adding a definition
of affiliated organization to § 403.802.
This definition would allow an
endorsed drug card sponsor to market to
its enrollees a Part D plan of an
affiliated organization if the
organization is legally separate and at
least one of the following conditions is
met:
(1) Both the affiliated organization
and the endorsed drug card sponsor are
under common control (common
control exists if another entity has the
power, directly or indirectly, to
significantly influence or direct the
actions or policies of the affiliated
organization and the endorsed drug card
sponsor);
(2) The affiliated organization is
under the control of the endorsed drug
card sponsor or the affiliated
organization controls the endorsed drug
card sponsor (control exists if an entity
has the power, directly or indirectly, to
significantly influence or direct the
actions or policies of another entity); or
(3) The affiliated organization
possesses an ownership or equity
interest of 5 percent or more in the
endorsed drug card sponsor on both:
The date on which the endorsed drug
card sponsor markets the affiliated
organization’s Part D plan; and the date
on which the endorsed drug card
sponsor signed its endorsement contract
with us. This is to ensure that the entity
is currently affiliated with the endorsed
sponsor and ensures that a Part D plan
does not acquire a drug card sponsor
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Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Rules and Regulations
after publication of this rule in order to
gain access to the sponsors’ drug card
enrollees.
We will not permit endorsed sponsors
to market to their drug card enrollees
Part D plans offered by unaffiliated third
parties (as described by this new
section) because an endorsed sponsor’s
marketing of a Part D plan offered by a
third party generally is prohibited by
the HIPAA privacy rule absent
authorization from the individual.
As important, information that is
provided by a drug card sponsor about
its or its affiliate’s Part D plan will, we
believe, be more likely to promote a
smoother transition to Part D since the
beneficiary is familiar with the endorsed
sponsor, and we anticipate that there
will be similarities between the
Medicare drug discount card and the
Part D plan (for example, similar
pharmacy network, similar formulary).
Furthermore, under certain
circumstances, HIPAA may prohibit an
endorsed sponsor’s marketing of Part D
plans offered by certain affiliated
entities. Thus, any use or disclosure of
enrollee’s protected health information
by an endorsed card sponsor must
comply with all Federal laws, including
the HIPAA Privacy Rule.
IV. Provisions of the Final Regulations
Except as mentioned below, this final
rule incorporates the marketing and
information and outreach provisions of
the interim final rule. This rule creates
a definition at section 403.802
pertaining to the requirements that must
be met before an organization will be
considered an affiliated organization to
an endorsed drug card sponsor.
We are also revising § 403.813 to
permit an endorsed card sponsor to
market to its drug card enrollees a Part
D plan offered by the endorsed sponsor
or an affiliated organization of the
endorsed sponsor.
We will require information and
outreach (marketing) materials provided
by an endorsed drug card sponsor that
are discussing Part D plan offerings to
be approved through the Medicare
Prescription Drug Benefit review
process as described under § 423.50.
V. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
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VI. Regulatory Impact
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) and Executive Order 13132.
Executive Order 12866 directs
agencies to assess all costs and 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). This rule does not reach
the economic threshold and thus is not
considered a major rule.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations, and small
governmental agencies. Most hospitals
and most other providers and suppliers
are small entities, either by nonprofit
status or by having revenues of $6
million to $29 million in any 1 year.
Individuals and States are not included
in the definition of a small entity. We
are not preparing an analysis for the
RFA because we have determined that
this rule will not have a significant
economic impact on a substantial
number of small entities.
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 that may result in expenditure in
any 1 year by State, local, or tribal
governments, in the aggregate, or by the
private sector, of $110 million. This rule
will have no consequential effect on the
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governments mentioned 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.
Since this regulation does not impose
any costs on State or local governments,
the requirements of E.O. 13132 are not
applicable.
In accordance with the provisions of
Executive Order 12866, this regulation
was not reviewed by the Office of
Management and Budget.
List of Subjects in 42 CFR Part 403
Grant programs—health, Health
insurance, Hospitals, Intergovernmental
relations, Medicare, Reporting and
recordkeeping requirements.
I For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV, as set forth below:
PART 403—SPECIAL PROGRAMS AND
PROJECTS
1. The authority citation for part 403
continues to read as follows:
I
Authority: 42 U.S.C. 1359b–3 and secs.
1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
2. In Subpart H, § 403.802 is amended
by adding in alphabetical order the
definitions of ‘‘Affiliated organization’’
and ‘‘Part D plan’’ to read as follows:
I
Subpart H—Medicare Prescription
Drug Discount Card and Transitional
Assistance Program
§ 403.802
Definitions.
*
*
*
*
*
Affiliated organization means an
organization that is a legally separate
entity from the endorsed drug card
sponsor and meets one of the following
conditions:
(1) The organization and the endorsed
drug card sponsor are under common
control. Common control exists if
another entity has the power, directly or
indirectly, to significantly influence or
direct the actions or policies of the
organization and the endorsed drug card
sponsor.
(2) The organization is under the
control of the endorsed drug card
sponsor or the organization controls the
endorsed drug card sponsor. Control
exists if an entity has the power,
directly or indirectly, to significantly
influence or direct the actions or
policies of another entity.
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(3) The organization possesses an
ownership or equity interest of 5
percent or more in the endorsed drug
card sponsor on both the date on which
the endorsed drug card sponsor markets
the organization’s Part D plan, and the
date on which the endorsed drug card
sponsor signed its endorsement contract
with CMS.
*
*
*
*
*
Part D plan has the meaning given the
term at § 423.4.
*
*
*
*
*
I 3. Section 403.806(g)(5) is amended
by—
I A. Revising paragraph (g)(5)(i).
I B. Revising paragraph (g)(5)(iii).
I C. Adding paragraph (g)(5)(vi).
The revisions and addition read as
follows:
Dated: July 8, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: August 10, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05–17424 Filed 8–29–05; 11:58 am]
§ 403.806 Sponsor requirements for
eligibility for endorsement.
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*
Medicare Program; Establishment of
the Medicare Advantage Program
*
*
*
*
(g) * * *
(5) * * *
(i) Comply with the Information and
Outreach Guidelines published by CMS
except as provided in paragraph
(g)(5)(vi) of this section.
*
*
*
*
*
(iii) If CMS does not disapprove the
initial submission of information and
outreach materials within 30 days of
receipt of these materials, the materials
are deemed approved under paragraph
(g)(5)(ii) of this section.
*
*
*
*
*
(vi) All materials related to products
and services that are Part D plans must
comply with the requirements specified
in § 423.50 of this chapter.
*
*
*
*
*
I 4. Section 403.813 is amended by
revising paragraph (a)(1) to read:
§ 403.813 Marketing limitations and record
retention requirements.
(a) Marketing limitations. (1) An
endorsed sponsor may only market the
following:
(i) Those products and services
offered under the endorsed program that
are inside the scope of endorsement
defined in § 403.806(h) and permitted
under § 403.812(b).
(ii) A Part D plan offered by the
endorsed sponsor or an affiliated
organization of the endorsed sponsor.
*
*
*
*
*
(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)
VerDate Aug<18>2005
14:19 Aug 31, 2005
Jkt 205001
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 422
[CMS–4069–F3]
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correcting
amendment; partial stay of
effectiveness.
AGENCY:
SUMMARY: This document corrects
technical errors that appeared in the
final rule published in the Federal
Register on January 28, 2005 entitled
‘‘Establishment of the Medicare
Advantage Program.’’ It also stays
several amendments made in the
previous rule.
EFFECTIVE DATES: This final rule is
effective March 22, 2005. Sections
422.152(a)(1) and (c), 422.156(b)(7),
422.316, and 422.527 are stayed from
September 1, 2005 until January 1, 2006.
FOR FURTHER INFORMATION CONTACT:
Christopher McClintick, (410) 786–
4682.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 05–1322 of January 28,
2005 (70 FR 4588), there were several
errors that we identify in the ‘‘Summary
of Errors’’ section and correct in the
‘‘Correction of Errors’’ section below.
The provisions in this correcting
amendment are effective as if they were
included in the final rule published
January 28, 2005. Accordingly, the
corrections are effective retroactive to
March 22, 2005, the effective date of
most of the provisions of the January 28,
2005 final rule, except for those
provisions that are specifically
designated in the EFFECTIVE DATES
section as being stayed effective
September 1, 2005 until January 1, 2006.
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
52023
II. Summary of Errors
In the January 28, 2005 final rule, on
page 4588, we inadvertently omitted
from the list of provisions that will
become effective January 1, 2006, the
following provisions relating to changes
in the quality improvement provisions
in subpart D: §§ 422.152(a)(1) and (c),
and 422.156(b)(7). These provisions
implement changes to section 1852(e) of
the Social Security Act (the Act) that,
under section 722(c) of the MMA, apply
to contract years beginning on and after
January 1, 2006. Sections 422.152(a)(1)
and (c) concern the requirement that an
MA organization must have a chronic
care improvement program for each
plan it offers. In order to clarify that
these provisions of the quality
improvement requirements do not apply
to contracts previous to contract periods
beginning January 1, 2006, and to
comply with the Act, we are staying the
effective dates of §§ 422.152(a)(1) and
(c) until January 1, 2006. We are also
staying § 422.156(b)(7), a quality
improvement provision concerning
deemable requirements and Part D
prescription drug programs offered by
MA programs. We also inadvertently
omitted from the list of provisions that
will become effective January 1, 2006,
the following provisions relating to
arrangements with federally qualified
health centers: §§ 422.316 and 422.527.
Section 237(c) of the MMA provides
that these changes apply to services
provided on or after January 1, 2006,
and contract years beginning on or after
that date. In order to clarify the effective
dates of these provisions and to bring
our regulations into conformance with
the statute, we are also staying the
effective dates of §§ 422.316 and
422.527 until January 1, 2006.
On page 4676, we clarify that an MA
organization and not a practitioner is
responsible for providing a written
notice to the beneficiary when an
adverse decision is made in an office
setting. In other words, if an enrollee
requests an explanation of a
practitioner’s denial of an item or
service, in whole or in part, the MA
organization is responsible for giving
the enrollee a written notice. We are
making a corresponding change to
§ 422.568(d) of the regulation text.
On page 4681, we inadvertently
specified 72 hours as the timeline for
the expedited grievance process MA
organizations must establish for
complaints involving certain procedural
matters in the appeals process. In that
discussion, we were referring to 42 CFR
422.564(d), which we redesignated in
the final rule as § 422.564(f), but did not
otherwise change. The timeline, as
E:\FR\FM\01SER1.SGM
01SER1
]]>Agencies
[Federal Register Volume 70, Number 169 (Thursday, September 1, 2005)]
[Rules and Regulations]
[Pages 52019-52023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17424]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 403
[CMS-4063-F]
RIN 0938-AN97
Medicare Program; Medicare Prescription Drug Discount Card;
Revision of Marketing Rules for Endorsed Drug Card Sponsors
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule will revise the current limitations
prohibiting an endorsed drug card sponsor from marketing its Part D
plans to its drug card enrollees. This revised rule will give the
current drug card sponsors the ability to market to their enrollees
Part D plans that are either offered by the same endorsed drug card
sponsor or an affiliated organization of the same endorsed drug card
sponsor. We are making these changes after considering the public
comments received regarding the need to ensure a smooth transition from
the drug card to the Medicare Prescription Drug Benefit.
DATES: Effective Date: These regulations are effective on October 1,
2005.
FOR FURTHER INFORMATION CONTACT: Jennifer Shapiro, (410) 786-7407.
SUPPLEMENTARY INFORMATION:
Availability of Final Rule
Electronic Copies: An electronic copy of this document may be
downloaded using a modem and suitable communications software. Internet
users may reach CMS's Web page at
https://www.cms.hhs.gov/regulations;
https://www.regulations.gov; or
https://www.gpoaccess.gpo/nara/.
Order Copies: To order copies of the Federal Register containing
this document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954.
Specify the date of the issue requested and enclose a check or
money order payable to the Superintendent of Documents, or enclose your
Visa or Master Card number and expiration date. Credit card orders can
also be placed by calling the order desk at (202) 512-1800 (or toll-
free at 1-888-293-6498) or by faxing to (202) 512-2250. The cost for
each copy is $10.
Photocopies: As an alternative, you can view and photocopy the
Federal Register document at most libraries designated as Federal
Depository Libraries and at many other public and academic libraries
throughout the country that receive the Federal Register.
I. Background
The Medicare drug discount card program was established by section
101, subpart 4, of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 and is codified in section 1860D-31 of the
Social Security Act (the ``Act''). On December 15, 2003, in accordance
with section 105(c)(1)(C) of the Act, we published the interim final
rule with comment period (hereafter referred to as ``interim final
rule'') for the Medicare drug discount card program on December 15,
2003 (68 FR 69840).
The interim final rule at Sec. 403.813(a) addresses marketing
limitations applicable to endorsed discount card sponsors in accordance
with section 1860D-31(h)(7)(B) of the Act. Under these marketing
limitations, an endorsed sponsor may only market those products and
services offered under its endorsed program that are inside the scope
of endorsement and permitted under the HIPAA Privacy Rule.
After considering the public comments on these issues we agree with
the commenters that this policy does not comply with the intent of the
Medicare Modernization Act which directs the Secretary to facilitate
efficient enrollment into Part D plans. This final rule allows an
endorsed card sponsor to market information to its Medicare drug card
enrollees concerning its Part D plans offered by the endorsed card
sponsor or an affiliated organization. This change will increase
Medicare beneficiaries' awareness and knowledge of Part D plans,
thereby facilitating a smooth transition from the Medicare Prescription
Drug Discount Card Program to the Medicare Prescription Drug Benefit.
Requirements for Issuance of Regulations
Section 902 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and
requires, in part, that the Secretary, in consultation with the
Director of the Office of Management and Budget establish and publish
timelines for the publication of Medicare final regulations based on
the previous
[[Page 52020]]
publication of a Medicare proposed or interim final regulation. Section
902(a)(1) of the MMA also states that the timelines for these
regulations may vary but shall not exceed 3 years after publication of
the preceding proposed or interim final regulation except under
exceptional circumstances.
Therefore, we believe that the final rule is in accordance with the
Congress's intent to ensure timely publication of final regulations.
II. Discussion of the Provisions of the Final Rule
A. Provision of the Interim Final Rule
Section 403.813(a)(1) of the December 15, 2003 interim final rule
provides that an endorsed sponsor may only market those products and
services offered under its endorsed program that are inside the scope
of endorsement as defined in Sec. 403.806(h) and permitted under Sec.
403.812(b) (pertaining to the HIPAA privacy requirements). Section
403.806(h)(2) defines products and services inside the scope of the
Medicare endorsement as products and services that are: (1) Directly
related to covered discount card drugs or discounts for over-the-
counter drugs; and (2) offered for no additional fee (other than the
enrollment fee).
Section 403.813(a) of the interim final rule provides that an
endorsed sponsor may not request that a drug card enrollee or an
individual seeking to enroll in its endorsed discount card program
authorize the endorsed sponsor to use or disclose individually
identifiable health information for marketing other products or
services not otherwise allowed under Sec. 403.813(a)(1) (Sec.
403.813(a)(2)); that an endorsed sponsor may not commingle any
materials related to the marketing of products or services allowed
under Sec. 403.813(a)(1) with other marketing materials (Sec.
403.813(a)(3)); and that following termination of an endorsed sponsor's
endorsement under Sec. 403.820(c), (d) or (e) or termination of the
Medicare Drug Discount Card and Transitional Assistance Program, a drug
card enrollee's individually identifiable health information collected
or maintained by an endorsed sponsor may not be used or disclosed for
purposes of marketing any product or service (Sec. 403.813(a)(4)).
These provisions on marketing limitations are based on section
1860D-31(h)(7)(B) of the Act, which states that an endorsed sponsor may
market a product or service under the program only if the product or
service is directly related to a covered discount card drug or a
discount price for a non-prescription drug, and on section 1860D-
31(h)(8) of the Act, which charges us with protecting and promoting the
interests of discount card eligible individuals.
In addition to the specific requirements of the Act that the
product or services be directly related to a covered discount card drug
or a discount on a non-prescription drug, Sec. 403.806(h)(2) of the
interim final regulation further requires that products and services
inside the scope of endorsement are limited to products or services
offered for no additional charge because, as we stated in the preamble,
we were concerned that beneficiaries would be unable to access
negotiated prices and transitional assistance, as intended by the
Congress, if endorsed sponsors required that they pay additional fees
for optional products and services. Further, we believed that
permitting endorsed sponsors to charge additional fees could be
confusing to beneficiaries. Also, if we were to allow endorsed sponsors
to charge additional fees, we believe beneficiaries might, in effect,
be charged annual enrollment fees higher than the $30 limit mandated by
section 1860D-31(c)(2)(B) of the Act, especially if endorsed sponsors
were to condition enrollment in their endorsed programs on
beneficiaries paying these additional fees.
III. Analysis of and Response to Public Comments
A. Overview of Comments
We received 49 public comments concerning the Medicare drug
discount card program. Of these comments, 8 timely comments were
received that addressed issues on marketing and information and
outreach in two separate areas. A summary of the major issues and our
responses are as follows:
Comment: Of the 8 comments related to marketing, 4 of the comments
expressed the need to minimize the potential for beneficiary confusion
and encouraged us to allow sponsors to provide enrollees with valuable
health education and other information. One commenter encouraged us to
ensure that the regulation reflect the intent of the conferees that
there be a seamless transition between the drug card program and the
Medicare Prescription Drug Benefit. The other commenters encouraged us
to create guidelines concerning marketing materials and fairness in
marketing. None of the comments were opposed to us issuing additional
guidelines.
Response: We agree with the commenters' concerns regarding the need
to minimize beneficiary confusion by allowing endorsed sponsors to
distribute certain important and valuable information to beneficiaries,
including information which will promote a smoother transition for drug
card enrollees from the Medicare-approved prescription drug discount
card program to the Medicare Prescription Drug Benefit. The Medicare
Prescription Drug, Improvement, and Modernization Act of 2003
Conference Report clearly articulates this intent where the report
discusses the history of the drug card program and its original purpose
as an interim step toward prescription drug coverage for Medicare
beneficiaries. Furthermore, a separate discussion appearing in the
Conference Report addressing Part D emphasizes the need to facilitate
outreach to beneficiaries to ensure participation in Medicare
prescription drug coverage and to reduce barriers associated with
marketing to minimize the potential for confusion and to facilitate
enrollment into the Medicare Prescription Drug Benefit.
We agree with the commenter that encouraged us to ensure that the
regulation reflect the intent of the conferees that there be a seamless
transition between the drug card program and the Medicare Prescription
Drug Benefit. As we move toward implementation of the Medicare
Prescription Drug Benefit, it has become evident that certain aspects
of the interim final rule are creating unintended consequences for
Medicare beneficiaries and endorsed card sponsors. Specifically the
marketing limitations at Sec. 403.813(a) contradict Congressional
intent for the Medicare prescription drug discount card program to
serve as a transitional program to the Medicare Prescription Drug
Benefit. As previously mentioned, the provisions in the interim final
rule prevent an endorsed drug card sponsor from marketing its Part D
plans to its drug card enrollees. Moreover, we agree that
clarifications and modifications to the marketing limitation rules
would reduce beneficiary confusion as the drug card program concludes
and the Medicare Prescription Drug Benefit begins. Finally, it is
crucial that Medicare beneficiaries have complete and accurate
information on the forthcoming Medicare Prescription Drug Benefit. We
agree with all comments that expressed an important aspect of ensuring
that beneficiaries receive this information is by allowing a
beneficiary's drug card sponsor, an entity with which the beneficiary
is familiar and has an existing relationship to provide educational and
related information
[[Page 52021]]
about the transition to the Medicare prescription drug benefit and the
Part D plans that will be offered by the endorsed sponsor or its
affiliated organizations. Allowing endorsed sponsors to provide
information to their members about certain Part D plans available to
them is a component of the Secretary's strategy for meeting his
obligation under sections 1851(d)(1) and 1860D-1(c) of the Act to
promote an active, informed selection by beneficiaries among their
Medicare coverage options.
As a result, this final rule amends Sec. 403.813(a)(1) to allow an
endorsed card sponsor to market to its drug card enrollees not only
items and products offered within the scope of endorsement, but also
Part D plans offered by the endorsed sponsor or an affiliated
organization of the endorsed sponsor.
Section 1860D-31(h)(7)(B) of the Act provides that endorsed
sponsors may only market products or services ``under the program'' if
they directly relate to either a covered discount card drug or discount
prices available for over-the-counter drugs. We believe products or
services marketed ``under the program'' include not only those within
the scope of endorsement, but also Part D plans. Because information
about Part D plans offered by an endorsed sponsor or its affiliated
organizations would reinforce the purpose of the Medicare prescription
drug discount card program to serve as a transitional program to the
Medicare prescription drug benefit, we believe marketing of such Part D
plans constitutes marketing of a product or service under the Medicare
prescription drug discount card program. In addition, we believe Part D
plans are directly related to covered discount card drugs, as evidenced
by the fact that the statutory definition of a covered drug under
section 1860D-31(a)(4)(a) of the Act cross-references the definition of
covered Part D drug under section 1860D-2(e) of the Act, and thus is
identical to the definition of covered Part D drug.
Therefore, we amend the marketing limitations in Sec.
403.813(a)(1) by explicitly stating that Part D plans offered by an
endorsed sponsor or its affiliated organization may be directly
marketed by the endorsed sponsor to its enrollees. We will not
otherwise change the marketing limitation provisions of the interim
final rule because we maintain that section 1860D-31(h)(8) of the Act
charges us with protecting and promoting the interests of Medicare
beneficiaries who may be unable to access negotiated prices and
transitional assistance, as intended by the Congress, if endorsed
sponsors require that they pay additional fees for optional products
and services, such as Part B supplies. Furthermore, permitting endorsed
sponsors to charge additional fees for products and services outside
the scope of the endorsement could be confusing to beneficiaries. Also,
if we were to allow endorsed sponsors to charge additional fees, we
believe beneficiaries might, in effect, be charged annual enrollment
fees higher than the $30 limit mandated by section 1860D-31(c)(2)(B) of
the Act, especially if endorsed sponsors were to condition enrollment
in their endorsed programs on beneficiaries paying these additional
fees. The amendment to allow marketing of Part D plans makes sense in
this instance because in this context it does not negate the intent or
practice of the original restriction (for example, regarding Part B
supplies). We believe that this amendment is consistent with the intent
of the Congress, which would reduce confusion and facilitate a smooth
transition to the Medicare Prescription Drug Benefit which protects and
promotes interests of all Medicare beneficiaries. Also, this exception
will not affect the enrollment fee.
We will require information and outreach (marketing) materials
discussing Part D plans that are disseminated by endorsed drug card
sponsors or their affiliated organizations to the endorsed sponsors'
drug card enrollees to be approved through the Medicare Prescription
Drug Benefit review process as described under Sec. 423.50 as opposed
to the drug card review process. This change addresses comments that
CMS should create guidelines concerning marketing materials and
fairness in marketing, and comments that we should endeavor to reduce
beneficiary confusion. Using a single review process, with consistent
guidelines specifically developed for Part D materials, is the optimal
process for ensuring adherence to guidelines and reducing beneficiary
confusion. Therefore, we are amending Sec. 403.806(g)(5) to state that
all materials related to Part D plans being offered by the same
endorsed sponsor or its affiliated organization must comply with the
requirements described in Sec. 423.50.
We are cognizant that constraints and clarifications must be made
about whose products an endorsed card sponsor may provide marketing
materials about to its drug card enrollees. An endorsed drug card
sponsor may market a Part D plan offered by it or its affiliated
organization. By allowing an endorsed card sponsor to market Part D
plans offered by an affiliated organization of the endorsed sponsor, we
are treating Part D plans offered by an affiliated organization of the
endorsed sponsor as a product or service under the program. Allowing
such treatment gives practical effect to the Congressional intent of a
smooth transition between the drug card program and the Medicare
Prescription Drug Benefit because it recognizes that rather than offer
Part D plans through the same legal entity, organizations may have
legitimate business and legal reasons for offering Part D plans through
another legal entity, or may offer Part D plans through different legal
entities based on geography (for example, Part D plans in region A
offered through legal entity A, Part D plans in region B offered
through legal entity B). We do not want to constrain an organization's
ability to offer its Part D plans through the legal entities that make
the most sense given other business and legal considerations. A Part D
Plan is not offered under the program, however, if the plan is offered
by an organization that is not the endorsed sponsor or an affiliated
organization of the endorsed sponsor.
Therefore, we are adding a definition of affiliated organization to
Sec. 403.802. This definition would allow an endorsed drug card
sponsor to market to its enrollees a Part D plan of an affiliated
organization if the organization is legally separate and at least one
of the following conditions is met:
(1) Both the affiliated organization and the endorsed drug card
sponsor are under common control (common control exists if another
entity has the power, directly or indirectly, to significantly
influence or direct the actions or policies of the affiliated
organization and the endorsed drug card sponsor);
(2) The affiliated organization is under the control of the
endorsed drug card sponsor or the affiliated organization controls the
endorsed drug card sponsor (control exists if an entity has the power,
directly or indirectly, to significantly influence or direct the
actions or policies of another entity); or
(3) The affiliated organization possesses an ownership or equity
interest of 5 percent or more in the endorsed drug card sponsor on
both: The date on which the endorsed drug card sponsor markets the
affiliated organization's Part D plan; and the date on which the
endorsed drug card sponsor signed its endorsement contract with us.
This is to ensure that the entity is currently affiliated with the
endorsed sponsor and ensures that a Part D plan does not acquire a drug
card sponsor
[[Page 52022]]
after publication of this rule in order to gain access to the sponsors'
drug card enrollees.
We will not permit endorsed sponsors to market to their drug card
enrollees Part D plans offered by unaffiliated third parties (as
described by this new section) because an endorsed sponsor's marketing
of a Part D plan offered by a third party generally is prohibited by
the HIPAA privacy rule absent authorization from the individual.
As important, information that is provided by a drug card sponsor
about its or its affiliate's Part D plan will, we believe, be more
likely to promote a smoother transition to Part D since the beneficiary
is familiar with the endorsed sponsor, and we anticipate that there
will be similarities between the Medicare drug discount card and the
Part D plan (for example, similar pharmacy network, similar formulary).
Furthermore, under certain circumstances, HIPAA may prohibit an
endorsed sponsor's marketing of Part D plans offered by certain
affiliated entities. Thus, any use or disclosure of enrollee's
protected health information by an endorsed card sponsor must comply
with all Federal laws, including the HIPAA Privacy Rule.
IV. Provisions of the Final Regulations
Except as mentioned below, this final rule incorporates the
marketing and information and outreach provisions of the interim final
rule. This rule creates a definition at section 403.802 pertaining to
the requirements that must be met before an organization will be
considered an affiliated organization to an endorsed drug card sponsor.
We are also revising Sec. 403.813 to permit an endorsed card
sponsor to market to its drug card enrollees a Part D plan offered by
the endorsed sponsor or an affiliated organization of the endorsed
sponsor.
We will require information and outreach (marketing) materials
provided by an endorsed drug card sponsor that are discussing Part D
plan offerings to be approved through the Medicare Prescription Drug
Benefit review process as described under Sec. 423.50.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
VI. Regulatory Impact
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) and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
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). This rule
does not reach the economic threshold and thus is not considered a
major rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
agencies. Most hospitals and most other providers and suppliers are
small entities, either by nonprofit status or by having revenues of $6
million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity. We are not preparing an
analysis for the RFA because we have determined that this rule will not
have a significant economic impact on a substantial number of small
entities.
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 that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. This rule will have no consequential effect on
the governments mentioned 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. Since this regulation does not impose any costs on State
or local governments, the requirements of E.O. 13132 are not
applicable.
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 403
Grant programs--health, Health insurance, Hospitals,
Intergovernmental relations, Medicare, Reporting and recordkeeping
requirements.
0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV, as set forth below:
PART 403--SPECIAL PROGRAMS AND PROJECTS
0
1. The authority citation for part 403 continues to read as follows:
Authority: 42 U.S.C. 1359b-3 and secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and 1395hh).
0
2. In Subpart H, Sec. 403.802 is amended by adding in alphabetical
order the definitions of ``Affiliated organization'' and ``Part D
plan'' to read as follows:
Subpart H--Medicare Prescription Drug Discount Card and
Transitional Assistance Program
Sec. 403.802 Definitions.
* * * * *
Affiliated organization means an organization that is a legally
separate entity from the endorsed drug card sponsor and meets one of
the following conditions:
(1) The organization and the endorsed drug card sponsor are under
common control. Common control exists if another entity has the power,
directly or indirectly, to significantly influence or direct the
actions or policies of the organization and the endorsed drug card
sponsor.
(2) The organization is under the control of the endorsed drug card
sponsor or the organization controls the endorsed drug card sponsor.
Control exists if an entity has the power, directly or indirectly, to
significantly influence or direct the actions or policies of another
entity.
[[Page 52023]]
(3) The organization possesses an ownership or equity interest of 5
percent or more in the endorsed drug card sponsor on both the date on
which the endorsed drug card sponsor markets the organization's Part D
plan, and the date on which the endorsed drug card sponsor signed its
endorsement contract with CMS.
* * * * *
Part D plan has the meaning given the term at Sec. 423.4.
* * * * *
0
3. Section 403.806(g)(5) is amended by--
0
A. Revising paragraph (g)(5)(i).
0
B. Revising paragraph (g)(5)(iii).
0
C. Adding paragraph (g)(5)(vi).
The revisions and addition read as follows:
Sec. 403.806 Sponsor requirements for eligibility for endorsement.
* * * * *
(g) * * *
(5) * * *
(i) Comply with the Information and Outreach Guidelines published
by CMS except as provided in paragraph (g)(5)(vi) of this section.
* * * * *
(iii) If CMS does not disapprove the initial submission of
information and outreach materials within 30 days of receipt of these
materials, the materials are deemed approved under paragraph (g)(5)(ii)
of this section.
* * * * *
(vi) All materials related to products and services that are Part D
plans must comply with the requirements specified in Sec. 423.50 of
this chapter.
* * * * *
0
4. Section 403.813 is amended by revising paragraph (a)(1) to read:
Sec. 403.813 Marketing limitations and record retention requirements.
(a) Marketing limitations. (1) An endorsed sponsor may only market
the following:
(i) Those products and services offered under the endorsed program
that are inside the scope of endorsement defined in Sec. 403.806(h)
and permitted under Sec. 403.812(b).
(ii) A Part D plan offered by the endorsed sponsor or an affiliated
organization of the endorsed sponsor.
* * * * *
(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: July 8, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: August 10, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-17424 Filed 8-29-05; 11:58 am]
BILLING CODE 4120-01-P
