[Federal Register Volume 67, Number 44 (Wednesday, March 6, 2002)]
[Proposed Rules]
[Pages 10293-10296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5130]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 403

[CMS-4032-ANPRM]
RIN 0938-AL30


Medicare Program; Medicare-Endorsed Prescription Drug Discount 
Card Assistance Initiative for State Sponsors

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: This advance notice of proposed rulemaking cross-references 
the proposed rule entitled ``Medicare Program; Medicare-Endorsed 
Prescription Drug Card Assistance Initiative'', published elsewhere in 
this Federal Register issue. This advance notice of proposed rulemaking 
describes how States could partner with private discount card sponsors 
under that proposed rule, and outlines additional steps that the 
Department of Health and Human Services (HHS) is considering to propose 
in support of current State efforts to make more readily available 
affordable prescription drugs to Medicare beneficiaries, including 
efforts to help low income Medicare beneficiaries access lower prices 
for prescription drugs.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on May 6, 2002.

ADDRESSES: In commenting, please refer to file code CMS-4032-ANPRM. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. Mail written comments (one original and 
three copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-4032-ANPRM, P.O. Box 8013, Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be timely 
received in the event of delivery delays.
    If you prefer, you may deliver (by hand or courier) your written 
comments (one original and three copies) to one of the following 
addresses: Department of Health and Human Services, Hubert H. Humphrey 
Building, 200 Independence Avenue, Room 443-G, Washington DC 20201, or 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Room 
C5-16-03, Baltimore, MD 21244-1850.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and could be considered late.
    For information on viewing public comments, see the beginning of 
the Supplementary Information section.

FOR FURTHER INFORMATION CONTACT: Debbie Van Hoven, (410) 786-8070.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: Comments 
received timely will be available for public inspection as they are 
received, generally beginning approximately 3 weeks after publication 
of a document, at the headquarters of the Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, 
Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule 
an appointment to view public comments, telephone (410) 768-7197.

I. Background

    In a related proposed rule entitled, ``Medicare Program; Medicare-
Endorsed Prescription Drug Card Assistance Initiative'', published 
elsewhere in this Federal Register issue, we propose providing 
assistance and education to all Medicare beneficiaries, and especially 
those without prescription drug coverage, to lower their out-of-pocket 
prescription drug costs. We would provide a Medicare endorsement to 
reputable and high quality private sector prescription drug discount 
card programs, based on requirements designed to make the best use of 
the strengths of the private sector. We would also educate 
beneficiaries about the private sector tools these programs would use, 
so that beneficiaries who could benefit from a prescription drug 
discount card would be able to compare and understand which Medicare-
endorsed card would best meet their needs. While it would be possible 
for States to cooperate and partner with

[[Page 10294]]

these private sector programs under that proposed rule, a State would 
not be allowed to apply directly to us to have its own privately 
administered prescription discount card program endorsed by Medicare. 
This advance notice of proposed rulemaking outlines additional steps 
that the Department of Health and Human Services (HHS) is considering 
to propose in support of current State efforts to make more readily 
available affordable prescription drugs to Medicare beneficiaries, 
including efforts to help low income Medicare beneficiaries access 
lower prices for prescription drugs.
    With limited exceptions, the Medicare benefit package currently 
does not include an outpatient prescription drug benefit. While 
approximately 73 percent of Medicare beneficiaries have drug coverage 
at any given time (under, for example, employer-sponsored retiree 
health plans or Medicaid), an estimated 10 million have no drug 
coverage. Without access to the discounts and rebates that come with 
most kinds of prescription drug coverage, many beneficiaries either pay 
list prices for drugs or have access only to drug discount programs 
that include modest discounts at the pharmacy. These beneficiaries 
often do not have access to many of the valuable services offered by 
some drug benefit and drug assistance programs, including services such 
as drug interaction and allergy monitoring. Further, a substantial 
share of beneficiaries have little experience with choosing among 
prescription drug plans, as envisioned in almost all Medicare drug 
benefit proposals being considered by the Congress. This, along with 
our need to operationalize such a complex benefit, implies a 
substantial ``lead time'' for successful implementation of a 
prescription drug benefit. In his fiscal year 2002 and 2003 budgets, 
the President proposed adding a prescription drug benefit for all 
Medicare beneficiaries. In the interim, before the Medicare drug 
benefit can be enacted and fully implemented, the President believes 
that beneficiaries should have access to rebates or discounts from 
pharmaceutical manufacturers on prescription drugs, as well as to the 
pharmaceutical management services that are commonly available in good 
private insurance plans.
    The objectives of the private sector oriented Medicare-Endorsed 
Prescription Drug Discount Card Assistance Initiative described in the 
proposed rule published elsewhere in this Federal Register issue would 
be to:
     Educate Medicare beneficiaries about private market 
methods available for securing substantial discounts from manufacturers 
and other competitive sources on the purchase of prescription drugs.
     Provide a mechanism for Medicare beneficiaries to gain 
access to the effective tools widely used by pharmacy benefit managers 
and pharmacies to get higher quality pharmaceutical care, for example, 
monitoring for drug interactions and allergies.
     Publicize information (including drug-specific prices, 
formularies, and networks) to facilitate easy consumer comparisons that 
would allow Medicare beneficiaries to choose the best card for them.
     Enhance and stabilize participation of Medicare 
beneficiaries in effective prescription drug assistance programs, 
increasing the leverage and ability of these programs to negotiate 
manufacturer rebates or discounts for Medicare beneficiaries and to 
provide other valuable pharmacy services.
     Enhance the quality and use of Medicare-covered services 
by improving access to prescription drugs.
     Endorse qualified private sector prescription drug card 
programs (either for profit or non-profit), based on structure and 
experience; customer service; pharmacy network adequacy; ability to 
offer manufacturer rebates or discounts (passing through a substantial 
portion to beneficiaries, either directly or indirectly through 
pharmacies), and available pharmacy discounts; and permit endorsed 
entities to market their programs as Medicare-endorsed.
     Provide Medicare beneficiaries a low (in Year One, $25 
maximum) or no-cost opportunity to enroll in a Medicare-endorsed 
prescription drug discount card program.
    To receive a Medicare endorsement, private prescription drug 
discount card program sponsors would be required to apply for 
endorsement, demonstrate that they meet all of the requirements 
concerning: (1) applicant structure, experience and participation in 
the administrative consortium; (2) customer service; and (3) rebates, 
discounts and access; and enter into a formal agreement with us.
    The proposed requirements for Medicare endorsement are tailored to 
reflect the strengths of the private market place to provide Medicare 
beneficiaries with high quality services, as well as to protect the 
integrity of the initiative, beneficiaries, and the Medicare name from 
firms with questionable business practices.
    While we believe that all of these requirements are important to 
assuring best practice in the private sector, we do not believe they 
are all well suited for States that are already sponsoring privately 
administered discount card programs. For example, the definition of a 
regional sponsor includes providing service in at least two contiguous 
states. Clearly a single State would not meet this criterion.
    Private sector drug discount program sponsors also would have to 
agree to abide by the guidelines of, jointly administer, and fund a 
privately run administrative consortium, intended, among other roles, 
to review and approve sponsors' marketing materials. It is not clear 
that a State would be able to participate in and fund such an 
administrative consortium as a full member, as contemplated in the 
proposed rule.
    Additionally, some customer service standards and the specific 
beneficiary confidentiality requirements for private sector sponsors 
may not be appropriate for States, as their infrastructure to support 
the public is designed to serve a myriad of needs, and these 
requirements are intended to protect Medicare beneficiaries, a goal 
already shared and being acted upon by States.
    Also, some State programs may currently enroll other populations, 
as well as Medicare beneficiaries. A State may need flexibility to 
design its program to be more inclusive in order to be consistent with 
its public mission. In particular, some State programs may be targeted 
to people with low incomes, including Medicare beneficiaries. 
Similarly, States may also want flexibility concerning the requirements 
to accept all Medicare beneficiaries and to limit enrollment to only 
Medicare beneficiaries. For example, some States may have prescription 
drug discount programs for some segments of the Medicare population, 
such as only those 65 years old and older, or for larger segments of 
the senior population beyond those eligible for Medicare, such as those 
age 60 and older.
    Under the private sector initiative described in the proposed rule 
published elsewhere in this Federal Register issue, States would be 
able to partner with private discount card program sponsors by 
selecting a Medicare-endorsed program and offering its own endorsement, 
and having a distinct card that reflects the State endorsement. States 
would not be given a Medicare endorsement for a discount card program. 
Rather, States could provide their own endorsement of a private sector 
discount card program that was also endorsed by Medicare, with the 
following restrictions.
    One restriction would be that the private sector program would be 
required to continue to operate for the

[[Page 10295]]

State as it is defined in the private drug discount card program 
sponsor's agreement with us. Specifically, we would allow drug 
formularies and prices to vary geographically, but they could not vary 
among different populations in the same area. Also, the endorsed 
discount card program would only enroll Medicare beneficiaries. 
Further, the card program would have to be available to all Medicare 
beneficiaries in a State, and we would not allow it to be restricted to 
only certain Medicare beneficiaries, such as those age 65 and over, or 
those with certain levels of income. However, different populations 
could be segmented for marketing purposes provided the marketing 
materials would not mislead or intentionally misrepresent to the public 
the nature of the endorsed program, and marketing activities would 
include marketing to beneficiaries with disabilities, beneficiaries 
with End-Stage Renal Disease (ESRD), and beneficiaries age 65 and over.

II. Purpose of Advance Notice of Proposed Rulemaking

    We are aware that a number of States are implementing privately 
administered programs that would lower the out-of-pocket prescription 
drug costs of low income Medicare beneficiaries. Some of these State 
programs parallel the proposed Medicare private sector initiative 
published elsewhere in this Federal Register issue in three important 
aspects--using voluntary market participation, obtaining manufacturer 
rebates or discounts, and administering the programs through private 
enterprise. State programs contain different design elements to secure 
discounts on prescription drugs for Medicare beneficiaries.
    We are particularly interested in exploring cooperative approaches 
we could pursue with the States to support the types of State 
initiatives that, like the proposed Medicare private sector initiative, 
rely on market forces and on the private sector for administration. 
These are structures that underlay Medicare drug benefit proposals 
being seriously considered by the Congress. Concerning market forces, 
we are specifically considering support for State programs in which the 
rebates and discounts are driven by competition for market share rather 
than by mandated levels. The experience gained under these State 
initiatives would inform policy makers as Medicare drug benefit 
proposals are being debated, and would assist beneficiaries, 
government, and the market place in preparing for a Medicare drug 
benefit.
    We invite comments on a possible Medicare endorsement of States 
efforts to lower beneficiaries' out-of-pocket costs for prescription 
drugs, using market-based strategies. For example, one consideration 
regarding State programs is whether the requirement under the private 
initiative to obtain rebates or discounts from drug manufacturers and 
share them with beneficiaries should apply to State efforts as well. We 
are aware that some State drug discount programs, at least initially, 
have not included manufacturer rebates or discounts that are passed on 
to consumers.
    Concerning State partnerships under the proposed private sector 
initiative published elsewhere in this Federal Register issue, we 
invite comments to better understand State-specific circumstances under 
which we would consider a private sponsor's agreement with us to vary 
from the required terms and conditions. Specifically, we would like to 
understand whether we should allow enrollment beyond Medicare 
beneficiaries, for example to include people with low incomes, or allow 
targeting of deeper discounts to low income Medicare beneficiaries, in 
order to help align the terms of our endorsement with the State's 
objectives to assist consumers in lowering their out-of-pocket spending 
on prescription drugs and accessing high quality prescription drug 
services.

III. Objectives of the Advance Notice of Proposed Rulemaking

    We are considering issuing a proposed rule that would provide 
Medicare endorsement for State efforts built on market principles and 
private sector administration to make more readily available affordable 
prescription drugs to Medicare beneficiaries, including efforts to help 
low income Medicare beneficiaries access lower prices for prescription 
drugs, where these efforts also parallel the objectives of the proposed 
Medicare Endorsed Prescription Drug Card Assistance Initiative.
    We believe that the statutory authorities cited in the related 
proposed rule entitled, ``Medicare Program; Medicare-Endorsed 
Prescription Drug Card Assistance Initiative'', published elsewhere in 
this Federal Register issue, would also support an initiative to 
endorse State sponsored efforts that provide access to lower cost 
prescription drugs for Medicare beneficiaries. Access to more 
affordable prescription drugs would assist beneficiaries in receiving 
services under Medicare and other health insurance programs, because 
this access could lead them to more effectively or efficiently use 
Medicare services, such as physician or hospital services. Endorsement 
of State sponsored drug discount programs would also improve 
beneficiary understanding of the various tools and programs available 
for receiving rebates and discounts on prescription drugs and for 
improving the pharmacy services they receive.
    Accordingly, we are considering a proposal to provide Medicare 
assistance in the form of an endorsement for, and beneficiary education 
about, State programs for those States that volunteer to apply for the 
Medicare endorsement and meet the following objectives:
     Educate Medicare beneficiaries about market-based methods 
available for securing substantial discounts from manufacturers and 
other competitive sources on the purchase of prescription drugs.
     Provide a mechanism for Medicare beneficiaries to gain 
access to the effective tools widely used by pharmacy benefit managers 
and pharmacies to get higher quality pharmaceutical care, for example, 
monitoring for drug interactions and allergies.
     Publicize information (including drug-specific prices, 
formularies, and networks) to facilitate easy consumer comparisons that 
would allow Medicare beneficiaries to choose the best card for them.
     Enhance and stabilize participation of Medicare 
beneficiaries in effective drug assistance programs, increasing the 
leverage and ability of these programs to negotiate manufacturer 
rebates or discounts for Medicare beneficiaries and to provide other 
valuable pharmacy services.
     Enhance the quality and use of Medicare-covered services 
by improving access to prescription drugs.
     Endorse qualified State sponsored prescription drug card 
programs that are privately administered and for which lower 
prescription drug prices are driven by competition, using criteria 
concerning: structure and experience; customer service; pharmacy 
network adequacy; ability to offer manufacturer rebates or discounts 
(passing through a substantial portion to beneficiaries, either 
directly or indirectly through pharmacies), and available pharmacy 
discounts; and permit States to market their programs as Medicare-
endorsed.
     Provide Medicare beneficiaries a low (in Year One, $25 
maximum) or no-cost opportunity to enroll in a Medicare-endorsed 
prescription drug discount card program.

[[Page 10296]]

    We invite comments on the appropriateness and adequacy of these 
objectives for States assisting consumers, particularly Medicare 
beneficiaries, in lowering their out-of-pocket costs for prescription 
drugs and improving the accessibility and quality of prescription drug 
services using market based approaches.
    We request comments on the appropriateness of the qualifications 
requirements for selecting States for endorsement concerning: (1) 
Applicant structure, experience, and relationship with the 
administrative consortium; (2) customer service; and (3) rebates, 
discounts, and access, as found in Section I.E of the proposed rule 
cross-referenced in this advance notice of proposed rulemaking, and 
published elsewhere in this Federal Register issue. We also request 
comments on other terms of the proposed initiative described in that 
proposed rule, as they would apply to State sponsored drug discount 
card programs.

IV. Response to Comments

    Because of the large number of comments we normally receive on a 
proposed rule, we are not able to acknowledge or respond to them 
individually. However, we will consider all comments we receive by the 
date and time specified in the Dates section of this advance notice of 
proposed rulemaking, and will address these comments in any proposed 
regulation that results from this advance notice.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: December 18, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.

    Dated: December 18, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 02-5130 Filed 2-28-02; 4:00 pm]
BILLING CODE 4120-01-P