[Federal Register Volume 69, Number 124 (Tuesday, June 29, 2004)]
[Notices]
[Pages 38898-38906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14673]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-5025-N]
RIN 0938-ZA51


Medicare Program; Medicare Replacement Drug Demonstration

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

ACTION: Notice.

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SUMMARY: This notice announces the implementation of a demonstration 
that would pay through December 31, 2005 under Medicare Part B for 
drugs and biologicals that are prescribed as replacements for existing 
covered Medicare drugs and biologicals described in section 
1861(s)(2)(A) or 1861(s)(2)(Q), or both, of title XVIII of the Social 
Security Act. Under this demonstration certain self-injected or oral 
drugs that are not normally covered under Medicare Part B would be 
covered if they were a replacement for a non self-administered drug or 
biological normally provided in a physician's office. The statute 
requires cost sharing in the same manner as Medicare Part D. No more 
than 50,000 patients may be covered under the demonstration and total 
funding is limited to $500 million.

ADDRESSES: Mail: Written inquiries regarding this demonstration must be 
submitted by mail to the following address: Centers for Medicare & 
Medicaid Services, Attn: Jody Blatt, Division of Payment Policy 
Demonstrations, Office of Research, Development, and Information, 
Centers for Medicare & Medicaid Services, C4-15-27, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850. Please allow sufficient time 
for mailed information to be received in a timely manner in the event 
of delivery delays.
    E-mail: Inquiries may be sent to the following e-mail address: 
[email protected]. Because of staffing and resource 
limitations, we cannot accept applications by facsimile (FAX) 
transmission.

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FOR FURTHER INFORMATION CONTACT: Jody Blatt, (410) 786-6921 or 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 641 of the Medicare Prescription Drug, Improvement and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173) provides for a 
demonstration that would pay under Medicare Part B for drugs and 
biologicals that are prescribed as replacements for existing covered 
Medicare drugs and biologicals described in section 1861(s)(2)(A) or 
1861(s)(2)(Q), or both, of title XVIII of the Social Security Act (the 
Act).
    For example, under this demonstration certain oral or self-injected 
drugs that are not normally covered under Medicare Part B would be 
covered if they were a replacement for a non-self-administered drug or 
biologic that is normally provided in a physician's office or an oral 
chemotherapeutic drug or biologic agent that is currently covered by 
Medicare under Part B. The legislation requires cost sharing in the 
same manner as Medicare Part D. No more than 50,000 patients may be 
covered under the demonstration and total funding is limited to $500 
million. The demonstration is to commence with the acceptance of 
applications in July 2004 for coverage starting in September or October 
2004. The demonstration will terminate December 31, 2005. In 2006, 
these drugs will be covered under Part D of Medicare for all those 
beneficiaries who elect to enroll in Part D.

II. Provisions of the Notice

A. Covered Drugs

    In order to determine what drugs shall be covered under the 
demonstration, we established an inter-agency panel of clinicians to 
determine the criteria for defining what constitutes a ``replacement'' 
drug as provided in section 641 of the MMA. An initial set of criteria 
were shared with the public at an Open Door Forum held at CMS. Based on 
feedback received at this forum and subsequently in writing, the 
criteria have been modified. We are adopting the criteria proposed by 
this interagency panel as modified and have determined that, to be 
covered under this demonstration, a drug/biological must meet all of 
the following criteria:
    1. A drug or biological covered under this demonstration must meet 
the statutory requirement of being a replacement by eliminating the 
concurrent need for a currently covered drug or biological for a 
currently covered indication.
    2. Coverage of the drug or biological in the demonstration is 
limited to FDA approved indications and, for any drug with an existing 
FDA approved indication, any additional indication if such additional 
indication is being reviewed by the FDA; and the requester has received 
documentation from the FDA that no filing issues remain.
    3. The drug must be at least of equal efficacy to the covered drug 
for which it is a replacement.
    4. Use of the drug represents an advantage in terms of access and/
or convenience for patients compared to the currently covered drug.
    5. Drugs are not eligible for coverage under this demonstration if 
the drug they are replacing is not commonly provided incident to a 
physician service (for example, anti-hypertensives, antibiotics, oral 
hypoglycemics, etc.).
    These criteria are consistent with the statutory requirement under 
section 641(a) of the MMA that the demonstration include only drugs and 
biologicals that are replacements for drugs currently covered under 
Part B. Although the statute does not explicitly require us to cover 
all drugs and biologicals prescribed as replacements for drugs 
currently covered under Part B, we nevertheless considered doing so. 
However, in light of the legislative directives limiting funding for 
the demonstration to $500 million and enrollment in the demonstration 
to 50,000 beneficiaries, we concluded that this demonstration's limited 
resources should be allocated so as to maximize the aggregate benefit 
to the Medicare population. We believe the criteria set forth above 
achieves this by focusing resources on those drugs or biologicals that 
have proven efficacy for the conditions indicated as well as 
significantly improve access to important medications for severely ill 
beneficiaries. Using these criteria, we have identified the following 
drugs/biologicals as covered under this demonstration for the following 
conditions:

     Drugs Covered Under the Medicare Replacement Drug Demonstration
------------------------------------------------------------------------
                                          Drug/biological--compound name
    Demonstration covered indication               (brand name)
------------------------------------------------------------------------
Rheumatoid Arthritis...................  Adalimumab (Humira).
                                         Anakinra (Kineret).
                                         Etanercept (Enbrel).
Multiple Sclerosis.....................  Glatiramer acetate (Copaxone).
                                         Interferon beta--1a (Rebif,
                                          Avonex).
                                         Interferon beta--1b
                                          (Betaseron).
Osteoporosis (patient must be            Calcitonin--nasal (Miacalcin--
 homebound).                              nasal).
Pulmonary Hypertension.................  Bosentan (Tracleer).
Secondary Hyperparathyroidism..........  Doxercalciferol (Hectoral).
Paget's Disease........................  Alendronate (Fosamax).
                                         Risedronate (Actonel).
Hepatitis C............................  Pegylated interferon alfa-2a
                                          (Pegasys).
                                         Pegalated interferon alfa-2a
                                          (PEG-Intron).
CMV Retinitis..........................  Valcyte (Valganciclovir).
Anti-Cancer
    Cutaneous T-cell Lymphoma..........  Bexarotene (Targretin).
    Non-small cell lung cancer.........  Gefitinib (Iressa).
    Epithelial ovarian cancer..........  Altretamine (Hexalen).
    Chronic Myelogenous Lymphoma.......  Imatinib Mesylate (Gleevec).
    GI Stromal Tumor...................  Imatinib Mesylate (Gleevec).
    Anaplastic astrocytoma.............  Temozolomide (Temodar).
    Multiple Myeloma...................  Thalidomide (Thalomid).
    Breast Cancer......................  Hormonal therapy.
        Stage 2-4 only.................  Anastrozole (Arimidex).
                                         Exemestane (Aromasin).

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                                         Letrozole (Femara).
                                         Tamoxifen (Nolvadex).
                                         Toremifene (Fareston).
------------------------------------------------------------------------

    We will consider covering additional drugs if they meet the 
criteria specified above and if the enrollment and/or funding limit for 
the demonstration has not been reached or is projected to be reached 
before the end of the demonstration.
    If you believe that another drug/biological should be considered 
for coverage under this demonstration, please submit your request, 
along with all required supporting documentation, in writing as 
specified below.
    Requests for consideration must explicitly list the drug/biological 
to be covered (trade and generic names), manufacturer, FDA approved 
indication(s), intended disease(s) and/or patient populations for the 
demonstration project (including a reference to the applicable 
treatment guideline, for example, the National Comprehensive Cancer 
Network (NCCN) guideline), typical dosing pattern in each relevant 
patient population, the Part B covered drug/biological that will be 
replaced, and how it meets each of the criteria noted above. 
Additionally, you must submit information describing the projected 
average annual cost of the medication following typical dosing patterns 
and any savings that Medicare might realize as a result of using this 
drug/ biological as a replacement. Those requesting inclusion of a drug 
or biological that has not yet received FDA approval for the proposed 
indication but otherwise meets all of the criteria must submit a letter 
from the FDA verifying that the FDA has received all of the data it 
needs to complete its review and that no further filing issues remain.

B. Implementation

    We have entered into a contract with TrailBlazer Health 
Enterprises, L.L.C. (TrailBlazer) to handle eligibility determination, 
enrollment and claims processing for this demonstration. Under this 
arrangement, TrailBlazer will subcontract with Advance PCS, a Caremark 
Company (Caremark), to provide pharmacy benefit management (PBM) 
services.
    Starting July 6, 2004, TrailBlazer will begin accepting 
applications to participate in this demonstration. Applications may be 
downloaded from our Web site: http://www.cms.hhs.gov/researchers/demos/drugcoveragedemo.asp or obtained by calling 1-866-563-5386 any time 
after 8 a.m. Eastern time on July 6, 2004. Calls prior to that time 
will not be accepted. Applications must be received by 5 p.m. Eastern 
time September 30, 2004. Applications received by August 16, 2004 will 
be eligible for an early selection process for coverage under the 
demonstration effective September 1, 2004.
    Applications will be considered under two categories: (1) Those 
seeking coverage for a covered cancer drug and (2) those seeking 
coverage for any other replacement drug covered under the 
demonstration. The purpose of creating two enrollment categories is to 
insure that at least 40 percent of the available funding goes toward 
oral cancer treatments as specified in the Medicare Modernization Act 
of 2003 ``Conference Agreement.'' If more persons submit applications 
than we believe we can accommodate because of the limits for either or 
both of the enrollment categories specified, participants will be 
chosen on a random basis among all completed applications received. 
Notification to applicants of their status regarding participation in 
the demonstration will be sent out by October 13, 2004. For those 
participating in the demonstration, coverage will be effective October 
18, 2004.
    If fewer applications are received than the maximum number of 
enrollees permitted or than can be covered within the projected funding 
limits, then all eligible beneficiaries who have submitted applications 
by the deadline will be enrolled in the demonstration with an effective 
date of October 18, 2004. To the extent that enrollment slots remain 
unfilled and we project available funding for additional participants, 
additional applications will be considered on a rolling basis after 
that date, although we do not anticipate this will occur.
    Those selected to participate will receive a ``welcome packet'' 
from Caremark including information on how to fill their prescriptions 
as well as supplemental information about their demonstration pharmacy 
benefit.

C. Eligibility

    In order to be eligible for participation in this demonstration, a 
beneficiary must meet the following criteria:
     The beneficiary must have Part A and Part B.
     Medicare must be the beneficiary's primary health 
insurance.
     The beneficiary must reside in one of the 50 states or the 
District of Columbia.
    Beneficiaries who are members of Medicare Advantage or other 
Medicare coordinated care health plans as well as those covered under 
the traditional Medicare Fee-For-Service program are eligible to 
enroll.
    Because a primary purpose of this demonstration is to increase 
access to important medications in advance of the full implementation 
of the Medicare Part D drug benefit in 2006, those beneficiaries who 
already have a comprehensive drug coverage plan will not be eligible to 
enroll. This includes beneficiaries who are covered under Tricare, the 
PACE program under section 1894 of the Act, and most Medicaid and SCHIP 
plans, as well as those who are covered under a comprehensive Medicare 
Advantage plan or an employer or union sponsored retiree plan. However, 
beneficiaries without any drug coverage and beneficiaries with more 
limited drug coverage, such as that offered by Medicare supplemental 
(employer-sponsored prescription drug coverage (or other alternative 
coverage)) plans and some Medicare Advantage or other Medicare 
coordinated care health plans, are eligible to apply for participation. 
Beneficiaries who are eligible for VA benefits are also eligible to 
apply for this demonstration if they do not use their VA benefits to 
pay for medications. Beneficiaries with questions about eligibility may 
contact 1-866-563-5386. Beneficiaries who have a Medicare sponsored 
discount drug card may participate in the demonstration, but they may 
not use the card to pay for drugs or biologicals covered under the 
demonstration. A separate demonstration specific card will be issued to 
beneficiaries participating in this demonstration.
    In order to apply for this demonstration, a beneficiary must

[[Page 38901]]

obtain certification from their physician stating that the beneficiary 
(1) has a medical condition for which coverage of the demonstration 
drug is allowed under the demonstration and (2) either the physician 
has already written a prescription for the demonstration drug for the 
beneficiary or intends to do so if the beneficiary is enrolled in the 
demonstration. The beneficiary does not need to be taking either the 
demonstration drug or a specific Medicare Part B covered drug in order 
to be eligible for this demonstration. Beneficiaries who are newly 
diagnosed and/or for whom the covered drug is prescribed for the first 
time during the course of the demonstration may apply at that time and 
will be considered for participation in the demonstration to the extent 
new applications can be considered.
    Beneficiaries who participate in the demonstration will retain all 
of their Medicare benefits and should follow their physician's guidance 
regarding any changes in medication and/or treatment that may be 
medically appropriate.

D. Beneficiary Cost Sharing

    In accordance with the requirements of section 641 of the MMA, cost 
sharing under this demonstration must be applied in the same manner as 
the standard prescription drug benefit under Part D that will be 
effective in 2006, as described in section 1860D-2(b) of the Social 
Security Act (the ``Act''). However, because this demonstration will 
not begin covering benefits until September, beneficiary out-of-pocket 
cost sharing for 2004 will be pro-rated to approximately one-third of 
the standard amount to reflect the reduced benefit year. In 2005, the 
full standard cost-sharing amount will be applied.
    Therefore, while beneficiaries will not be required to pay a 
premium for participating in the demonstration, they will be required 
to meet an annual deductible before benefits are paid. This deductible 
will be applied each calendar year a beneficiary is covered, regardless 
of when the beneficiary enrolls in the demonstration.
    In 2005, a standard annual deductible of $250 will be applied. 
After the annual deductible has been reached, the beneficiary must pay 
25 percent coinsurance for the cost of each prescription until the 
beneficiary has received covered replacement drugs totaling $2,250, 
which includes amounts paid out of pocket by the beneficiary (the $250 
deductible plus $500 worth of ``25% coinsurance'' for a total of $750) 
and amounts paid by Medicare under this demonstration. Once the 
beneficiary has received $2,250 in replacement drugs, the beneficiary 
will be responsible for paying 100 percent of all costs of the covered 
replacement drug until the beneficiary has paid an additional $2,850 
for a total of $3,600 out-of-pocket. Covered replacement drug costs 
paid by an individual (such as a family member) or a state pharmacy 
assistance plan on the beneficiary's behalf, and low-income assistance 
paid by Medicare under the demonstration on behalf of beneficiaries 
eligible for such assistance (see II E. below), count toward the 
beneficiary's $3,600 ``out-of-pocket limit''. Under the demonstration, 
in some cases, funds provided by charitable organizations may also 
count toward the beneficiary's out-of-pocket limit. However, costs for 
which the beneficiary is reimbursed through insurance or otherwise, a 
group health plan, or other third-party payment arrangement do not 
count toward the $3,600 out-of-pocket limit. Once the $3,600 ``out-of-
pocket limit'' has been reached, the beneficiary will pay the greater 
of 5 percent of the cost of the covered replacement drug or a fixed co-
payment of $2 for generic or preferred brand drugs that are multiple 
source drugs (as defined in section 1927(k)(7)(A)(i)) or $5 for all 
other drugs.
    As noted above, due to fact that the demonstration is not starting 
in 2004 until approximately two-thirds of the calendar year has passed, 
out-of-pocket costs for beneficiaries who enroll in 2004 will be 
reduced by approximately two-thirds. The annual deductible will be 
reduced from $250 to $85. This deductible will be applied regardless of 
when in 2004 a beneficiary enrolls. Once the beneficiary has met the 
deductible, s/he will pay 25% of the next $660 in allowable costs until 
s/he has paid an additional $165 out-of-pocket. The beneficiary will 
then be responsible for paying 100 percent of the allowed cost of the 
covered replacement drug until the beneficiary has paid an additional 
$950 for a total of $1,200 out-of-pocket ($85 deductible plus $165 at 
the 25% coinsurance level plus $950 at the 100% coinsurance level). The 
table below summarizes the out-of-pocket costs under the demonstration 
for 2004 and 2005.

------------------------------------------------------------------------
                                2004  (Sept-Dec)       2005  (Jan-Dec)
------------------------------------------------------------------------
Deductible
    Standard Benefit *......   $85           $250
25% Coinsurance Range
     Allowable Cost    660           2,000
     of Drugs.
     25% Out of        165           500
     Pocket.
100% Coinsurance ``Donut''
     100% Out-of-      950           2,850
     Pocket Payments (in
     addition to above).
Catastrophic Limit
    1. Total Allowable Cost    1,695 **      5,100 **
     of Drugs.
    2. Total Out of Pocket     1,200         3,600
     Payments.
------------------------------------------------------------------------
* Some low-income beneficiaries, those with incomes between 135% and
  150% of the Federal Poverty Level, will also have the deductible
  reduced from $50 to $20 in 2004. Other low-income beneficiaries will
  not pay any deductible in either year.
** Because beneficiary cost-sharing under the demonstration that is paid
  for by a group health plan, insurer or otherwise, or similar third
  party payment arrangement will not count toward the annual out-of-
  pocket limit, the total drug spending amount that triggers
  catastrophic coverage may be higher for beneficiaries with these
  alternative sources of coverage.

    Beneficiaries may receive their drugs on a retail or mail order 
basis, but must get them through Caremark, the pharmacy benefit manager 
contracting with TrailBlazer to implement this demonstration. Caremark 
has a national network of pharmacies. More specific information about 
the network and pharmacies available can be obtained by calling 1-866-
563-5386. Upon enrolling in the demonstration, beneficiaries will be 
mailed a complete package of information, including a demonstration 
identification card and instructions on how to fill their prescriptions 
for the demonstration-covered drug. This card may be used

[[Page 38902]]

only for drugs covered under the demonstration.

E. Low-Income Assistance

    Beneficiaries who meet the criteria specified in Part D, section 
1860D-14 of the Act, for low-income assistance will be eligible for 
assistance under this demonstration. Tables 1A and 1B specify the 
different cost sharing requirements for the standard benefit level as 
well as the different low-income options for 2004 and 2005. Table 2 
identifies which benefit levels apply based on a person's annual income 
and available financial resources.
    Beneficiaries, or their authorized representatives, will be 
required to submit an application form attesting to the beneficiary's 
annual income and financial resources in order to be considered for the 
subsidy.

F. Application Instructions

    Starting on or before July 6, 2004, application forms will be 
available from our Web site: http://www.cms.hhs.gov/researchers/demos/drugcoveragedemo.asp. Alternatively, individuals may call 1-866-563-
5386 (TTY: 1-866-5387) any time after 8 a.m. Eastern time on July 6, 
2004 to have an application mailed to them. Calls prior to that time 
will not be accepted.
    Applications must be received by TrailBlazer by 5 p.m. eastern 
time, September 30, 2004. Applications should be sent to the following 
address: Medicare Replacement Drug Demonstration, c/o TrailBlazer 
Health Enterprises, L.L.C., P.O. Box 5136, Timonium, MD 21094.
    The application form consists of two parts. Both parts must be 
filled in completely and submitted by September 30, 2004 in order to be 
considered for the demonstration.
    The first part of the form requests basic demographic information, 
information on the drug being requested and the availability of 
alternative insurance coverage for prescription drugs. Because this 
demonstration is intended to increase access to prescription drugs, 
beneficiaries who have comprehensive, alternative drug coverage through 
Medicaid, SCHIP, the PACE program under section 1894 of the Act, 
Tricare, retiree insurance, or other source are not eligible to enroll. 
However, beneficiaries who have more limited drug coverage such as 
under a Medicare supplement (employer-sponsored prescription drug 
coverage (or other alternative coverage, including Medigap plans)) plan 
are eligible to enroll. Beneficiaries who are enrolled in a Medicare 
Advantage or other Medicare coordinated care health plan are also 
eligible to enroll if they do not have comprehensive drug coverage 
under that plan that would cover the replacement drug.
    The second part of the application form is a certification from the 
physician who is prescribing the replacement drug for the beneficiary. 
The physician must submit this signed statement specifying that he (or 
she) is prescribing or will be prescribing the medication for the 
covered condition.
    Beneficiaries who believe they qualify for low-income assistance 
(see II.E above) must also complete and sign an attestation of income 
and resources. The rules for low-income assistance, including coverage 
levels and determination of eligibility, have been established to be 
consistent with what will be in effect in 2006 when the Medicare Part D 
drug benefit is implemented. Information submitted on the application 
for low-income assistance is subject to formal verification by CMS. 
Enrollment in the demonstration will be determined on a ``need-blind'' 
basis, that is, without regard to whether a beneficiary has also 
submitted an application for the low-income subsidy. Moreover, 
applications for the low-income subsidy may be submitted at any time 
during the duration of the demonstration and will be considered as long 
as funds are available. However, the low-income subsidy will not be 
provided retroactively.

G. Submission of Written Materials

    Those wishing to propose additional drugs/biologicals to be 
considered for coverage under the demonstration must submit written 
information documenting how the proposed drug meets the criteria 
specified in section II(A) of this notice. While the format for this 
information is not prescribed, we are requesting that all of the 
criteria listed above be fully addressed in the materials submitted.
    Written materials may be submitted by mail or e-mail to the 
addresses listed above under ``Inquiries, Registration and Submission 
of Information.''
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III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
notice in the Federal Register and solicit public comment before a 
collection of information requirement is submitted to the Office of 
Management and Budget (OMB) for review and approval. In order to fairly 
evaluate whether an information collection must 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.

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     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.
    Due to the following reasons, CMS requested that OMB grant OMB 
emergency approval of the collection requirements associated with this 
demonstration Section 641 of the MMA: (1) The statute required that 
this demonstration begin 90 days after passage of the legislation, 
which was March 8, 2004; (2) due to the complexities of implementing 
this demonstration, CMS was unable to meet that deadline; and (3) 
because of the importance of this demonstration to beneficiaries with 
serious illnesses and the already delayed time frame, it was urgent 
that there not be further delays.
    Based on the justification referenced above for emergency approval, 
with OMB concurrence, on May 19, 2004 Volume 69, Number 97, Pages 
28894-28895, CMS announced the initiation of procedural requirements 
set forth in 5 CFR 1320.13 to facilitate compliance with Chapter 25 of 
Title 44 of United States Code. As the result, the collection 
requirements associated with this demonstration, ``Application for 
Participation in Medicare Replacement Drug Demonstration'', were 
approved under OMB control number 0938-0924.
    It should be noted that during the 180-day emergency approval 
period, CMS will publish a Federal Register notice announcing the 
initiation of an extensive 60-day public comment period on these 
requirements. Upon completion of the 60-day comment period, we will 
submit the requirements for OMB review and an extension of this 
emergency approval.

    Authority: Section 641 of the Medicare Prescription Drug 
Improvement and Modernization Act of 2003.

(Catalog of Federal Domestic Assistance Program No. 93.778 and No. 
93.774, Medicare--Supplementary Medical Insurance Program)

    Dated: June 4, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-14673 Filed 6-24-04; 3:00 pm]
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