Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE; Coverage of Phase II and Phase III Clinical Trials Sponsored by the National Institutes of Health National Cancer Institute, 35389-35391 [06-5432]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 118 / Tuesday, June 20, 2006 / Rules and Regulations
is estimated to vary from 0.5 hour to 4
hours per response, with an average of
1.25 hours per response, including time
for reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing the collection
of information. Because reports are filed
4 times per year, 54,000 responses
annually are expected. Thus, the total
annual respondent burden of the survey
is estimated at 67,500 hours (13,500
respondents times 4 times 1.25 hours
average burden). This estimate is the
same as the burden hours currently
carried for this collection in the OMB
inventory.
Comments regarding the burden
estimate or any other aspect of this
collection of information should be
addressed to: Director, Bureau of
Economic Analysis (BE–1), U.S.
Department of Commerce, Washington,
DC 20230, fax: 202–606–5311; and the
Office of Management and Budget,
O.I.R.A., Paperwork Reduction Project
0608–0004, Attention PRA Desk Officer
for BEA, via the Internet at
pbugg@omb.eop.gov, or by fax at 202–
395–7245.
Regulatory Flexibility Act
The Chief Counsel for Regulation,
Department of Commerce, has certified
to the Chief Counsel for Advocacy,
Small Business Administration, under
the provisions of the Regulatory
Flexibility Act (5 U.S.C. 605(b)), that
this rule will not have a significant
economic impact on a substantial
number of small entities. The factual
basis for the certification was published
in the proposed rule and is not repeated
here. No comments were received
regarding the economic impact of the
rule. As a result, no final regulatory
flexibility analysis was prepared.
List of Subjects in 15 CFR Part 806
International transactions, Economic
statistics, U.S. investment abroad,
Penalties, Reporting and recordkeeping
requirements.
Dated: May 26, 2006.
J. Steven Landefeld,
Director, Bureau of Economic Analysis.
For the reasons set forth in the
preamble, BEA is amending 15 CFR part
806 as follows:
I
wwhite on PROD1PC61 with RULES
PART 806—DIRECT INVESTMENT
SURVEYS
1. The authority citation for 15 CFR
part 806 continues to read as follows:
I
Authority: 5 U.S.C. 301; 22 U.S.C. 3101–
3108; E.O. 11961 (3 CFR, 1977 Comp., p. 86),
as amended by E.O. 12318 (3 CFR, 1981
VerDate Aug<31>2005
15:58 Jun 19, 2006
Jkt 208001
Comp., p. 173); E.O. 12518 (3 CFR, 1985
Comp., p. 348).
§ 806.14
[Amended]
2. Section 806.14 (e) is amended by
removing ‘‘$30,000,000’’ and adding
‘‘$40,000,000’’ in its place.
I
[FR Doc. E6–9608 Filed 6–19–06; 8:45 am]
BILLING CODE 3510–06–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket No. DoD–2006–HA–0143]
RIN 0720–0057
Civilian Health and Medical Program of
the Uniformed Services (CHAMPUS)/
TRICARE; Coverage of Phase II and
Phase III Clinical Trials Sponsored by
the National Institutes of Health
National Cancer Institute
Office of the Secretary, DoD.
Final rule.
AGENCY:
ACTION:
SUMMARY: The final rule allows the
Department of Defense to waive normal
requirements so that covered
beneficiaries can participate in Phase II
and Phase III clinical trials sponsored or
approved by the National Institutes of
Health National Cancer Institute (NIH
NCI). This waiver authority is expected
to promote beneficiary access to
promising new treatments and
contribute to the development of such
treatments.
DATES:
This rule is effective July 20,
2006.
TRICARE Management
Activity (TMA), Medical Benefits and
Reimbursement System, 16301 East
Centretech Parkway, Aurora, CO 80011–
9066
FOR FURTHER INFORMATION CONTACT:
Debra Hatzel, Medical Benefits and
Reimbursement Systems, TMA,
telephone (303) 676-3572. Questions
regarding payment of specific claims
under TRICARE should be addressed to
the appropriate TRICARE contractor.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
This final rule implements Title 10,
United States Code, section 1079(a)(13)
which provides for a waiver of the
general prohibition on coverage of
unproven medical treatments or
procedures in connection with clinical
trials sponsored or approved by the
National Institutes of Health National
Cancer Institute. This waiver is
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
35389
contingent upon the Secretary of
Defense’s determination that a waiver
will promote access to promising new
treatments and contribute to the
development of such treatments. Based
on the improved beneficiary access to
these trials, and the contributions to the
development of such treatments, it is in
the best interest of the Department and
its beneficiaries to continue to provide
access through an authorized waiver as
outlined in the proposed rule.
Clinical trials are the major avenue for
discovering, developing, and evaluating
new cancer therapies, and clinical trial
participants are among the first to
receive new cancer prevention or
treatment methods before they are
widely available. Many significant
medical discoveries in this field have
occurred as a direct result of clinical
trial participation. For example, because
of survival improvements seen in an
NCI-sponsored clinical trial, early
initiation of hormonal therapy has
become the standard of care in nodepositive prostrate cancer patients. Even
when they do not lead to new therapies,
clinical trials often answer important
questions and help move research
forward so that others may prevent or
survive this disease.
Cancer treatment trials may include
testing new drugs, new approaches to
surgery or radiation therapy, new
combinations of treatments, or new
methods such as gene therapy. Studies
that involve drugs or invasive
procedures are categorized by phase.
Phase I trials evaluate new cancer drugs
to determine what dose is safe, how a
new agent should be administered (by
mouth, injected into a vein, or injected
into the muscle), and how frequently
the treatment should be given. After
safety parameters have been established,
Phase II trials are conducted to assess
the effectiveness of an agent or
intervention against a specific type of
cancer. Phase III trials compare effective
treatments from Phase II studies to
conventional cancer treatments. Clinical
trials offer high quality care for cancer
prevention and treatment, and no
patient ever receives a placebo
(substance with active ingredients)
when effective care exists.
The Department of Defense (DoD) and
the National Cancer Institute (NCI)
established a partnership in 1994 to
conduct a demonstration project that
allowed patients with breast cancer to
participate in NCI-sponsored bone
marrow transplant clinical trials. This
demonstration project expanded in 1996
to include all cancers and NCIsponsored Phase II and III cancer
treatment clinical trials. The DoD–NCI
demonstration partnership was further
E:\FR\FM\20JNR1.SGM
20JNR1
wwhite on PROD1PC61 with RULES
35390
Federal Register / Vol. 71, No. 118 / Tuesday, June 20, 2006 / Rules and Regulations
expanded on June 21, 1999 to include
clinical trials related to prevention,
screening and early detection of cancer.
Because of the inherent safety risks and
unproven clinical benefits associated
with toxicology studies, Phase I clinical
trials were not included in this
demonstration.
Between January 1996 and July 2004,
approximately 350 TRICARE
beneficiaries have participated in NCIapproved clinical trials conducted in
doctors’ offices, community hospitals
and clinics, cancer centers, other
medical centers, and veterans’ and
military hospitals across the United
States. Healthcare costs for the DoD–NCI
demonstration have ranged from $5.8
million to $16 million per year, and
research has indicated that patient-care
costs associated with cancer clinical
trials are only slightly higher than the
costs associated with treating similar
patients outside of trials.
The Department of Defense hopes that
his permanent benefit will heighten the
awareness among our cancer patients
that clinical trials are a promising
treatment option and encourage them to
consider Phase II and Phase III clinical
trial participation. Participation in
clinical trials related to prevention,
screening, and early detection of cancer
will contribute to the growing base of
medical knowledge in these areas and
may lead to more effective treatments in
the future. Phase I trials will continue
to be excluded from coverage; also,
TRICARE will continue to deny
coverage for any items or services that
are already covered under the
investigational protocol. Only those
supplies and services that TRICARE
otherwise would have covered during
the normal course of treatment (to
include costs for screening tests to
determine clinical trial eligibility) will
be eligible for cost-sharing. This
continues the coverage policy which
was previously established for the DoD–
NCI cancer trials demonstration.
This final rule was previously
published in the Federal Register on
January 31, 2001 (66 FR 8365–8366).
The rule was withdrawn on February 7,
2001 (66 FR 9199) because it was
determined that it should not have been
published in accordance with the
Regulatory Review Plan. We are
reissuing this final rule with only minor
changes (‘‘CHAMPUS’’ changed to
‘‘TRICARE’’ where appropriate; minor
changes to paragraph numbers to reflect
current regulations); however, we are
repeating the entire final rule here for
the benefit of the public.
VerDate Aug<31>2005
16:35 Jun 19, 2006
Jkt 208001
II. Public Comments
The proposed rule was published in
the Federal Register on May 31, 2000
(65 FR 34627). No public comments
were received. The final rule is
consistent with the proposed rule.
III. Regulatory Procedures
Executive Order (EO) 12866 requires
that a comprehensive regulatory impact
analysis be performed on any
economically significant regulatory
action, defined as one which would
result in an annual effect of $100
million or more on the national
economy or which would have other
substantial impacts. This is not a
significant regulatory action under EO
12866 and has been reviewed by the
Office of Manpower and Budget.
The Regulatory Flexibility Act (RFA)
requires that each Federal agency
prepare, and make available for public
comment, a regulatory flexibility
analysis when the agency issues a
regulation which would have a
significant impact on a substantial
number of small entities. We certify that
this final rule will not significantly
affect a substantial number of small
entities.
This final rule will not impose
additional information collection
requirements on the public under the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 55).
List of Subjects in 32 CFR Part 199
Administrative practice and
procedure, Claims, Fraud, Healthcare,
Health insurance, Military personnel.
Accordingly, 32 CFR part 199 is
amended as follows:
I
PART 199—[AMENDED]
1. The authority citation for part 199
continues to read as follows:
I
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
55.
2. Section 199.4 is amended by adding
new paragraph (e)(26) and revising
paragraph (g)(15) introductory text to
read as follows:
I
§ 199.4
Basic program benefits.
*
*
*
*
*
(e) * * *
(26) National Institutes of Health
clinical trials. By law, the general
prohibition against CHAMPUS costsharing of unproven drugs, devices, and
medical treatments or procedures may
be waived in connection with clinical
trials sponsored or approved by the
National Institutes of Health National
Cancer Institute if it is determined that
such a waiver will promote access by
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
covered beneficiaries to promising new
treatments and contribute to the
development of such treatments. A
waiver shall only be exercised as
authorized under this paragraph.
(i) Demonstration waiver. A waiver
may be granted through a demonstration
project established in accordance with
Sec. 199.1(o) of this part.
(ii) Continuous waiver. (A) General.
As a result of a demonstration project
under which a waiver has been granted
in connection with a National Institutes
of Health National Cancer Institute
clinical trial, a determination may be
made that it is in the best interest of the
government and CHAMPUS
beneficiaries to end the demonstration
and continue to provide a waiver for
CHAMPUS cost-sharing of the specific
clinical trial. Only those specified
clinical trials identified under
paragraph (e)(26)(ii) of this section have
been authorized a continuous waiver
under CHAMPUS.
(B) National Cancer Institute (NCI)
sponsored cancer prevention, screening,
and early detection clinical trials. A
continuous waiver under paragraph
(e)(26) of this regulation has been
granted for CHAMPUS cost-sharing for
those CHAMPUS-eligible patients
selected to participate in NCI sponsored
Phase II and Phase III studies for the
prevention and treatment of cancer.
(1) TRICARE will cost-share all
medical care and testing required to
determine eligibility for an NCIsponsored trial, including the
evaluation for eligibility at the
institution conducting the NCIsponsored study. TRICARE will costshare all medical care required as a
result of participation in NCI-sponsored
studies. This includes purchasing and
administering all approved
chemotherapy agents (except for NCIfunded investigational drugs), all
inpatient and outpatient care, including
diagnostic and laboratory services not
otherwise reimbursed under an NCI
grant program if the following
conditions are met:
(i) The provider seeking treatment for
a CHAMPUS-eligible patient in an NCI
approved protocol has obtained preauthorization for the proposed treatment
before initial evaluation; and,
(ii) Such treatments are NCI
sponsored Phase II or Phase III
protocols; and,
(iii) The patient continues to meet
entry criteria for said protocol; and,
(iv) The institutional and individual
providers are CHAMPUS authorized
providers.
(2) TRICARE will not provide
reimbursement for care rendered in the
National Institutes of Health Clinical
E:\FR\FM\20JNR1.SGM
20JNR1
Federal Register / Vol. 71, No. 118 / Tuesday, June 20, 2006 / Rules and Regulations
Center or costs associated with nontreatment research activities associated
with the clinical trials.
(3) Cost-shares and deductibles
applicable to CHAMPUS will also apply
under the NCI-sponsored clinical trials.
(4) The Director, TRICARE (or
designee), shall issue procedures and
guidelines establishing NCI-sponsorship
of clinical trials and the administrative
process by which individual patients
apply for and receive cost-sharing under
NCI-sponsored cancer clinical trials.
(g) * * *
(15) Unproven drugs, devices, and
medical treatments or procedures. By
law, CHAMPUS can only cost-share
medically necessary supplies and
services. Any drug, device, or medical
treatment or procedure, the safety and
efficacy of which have not been
established, as described in this
paragraph (g)(15), is unproved and
cannot be cost-shared by CHAMPUS
except as authorized under paragraph
199.4(e)(26) of this part.
*
*
*
*
*
Dated: June 9, 2006.
L.M. Bynum,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 06–5432 Filed 6–19–06; 8:45 am]
BILLING CODE 5001–06–M
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[CGD07–06–074]
RIN 1625–AA09
Drawbridge Operation Regulations;
Welch Causeway (SR 699) Bridge, Gulf
Intracoastal Waterway, Mile 122.8,
Madeira Beach, Pinellas County, FL
Coast Guard, DHS.
Temporary final rule.
AGENCY:
wwhite on PROD1PC61 with RULES
SUMMARY: The Coast Guard is
temporarily changing the regulations
governing the operation of the Welch
Causeway (SR 699) Bridge, Gulf
Intracoastal Waterway mile 122.8,
Madeira Beach, Pinellas County,
Florida. This rule is needed to provide
vehicular traffic relief during heavy
vehicular traffic periods as well as
meeting the reasonable needs of
mariners during the construction of
nearby bridges. This bridge will open on
the hour and half hour, Friday, 2 p.m.
until 6 p.m., Saturday, Sunday and
Federal holidays from 10 a.m. until 6
p.m. until October 29, 2006.
VerDate Aug<31>2005
Regulatory Information
We did not publish a notice of
proposed rulemaking (NRPM) for this
regulation. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists
for not publishing an NPRM. Publishing
an NPRM was impracticable and
contrary to the public interest, because
the rule is needed to provide for
vehicular traffic relief during
construction of bridges and provides
provisions for vessels to transit through
the area on a twice an hour schedule
during heavy vehicular traffic periods.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after Federal Register publication.
This rule provides for scheduled bridge
openings for vessels to transit through
the bridge.
Background and Purpose
33 CFR Part 117
ACTION:
This rule is effective from June
20, 2006 until October 29, 2006.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket CGD07–06–
074 and are available for inspection or
copying at Commander (dpb), Seventh
Coast Guard District, 909 S.E. 1st
Avenue, Room 432, Miami, FL 33131,
between 7:30 a.m. and 4 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: Mr.
Barry Dragon, Project Officer, Seventh
Coast Guard District, Bridge Branch, at
(305) 415–6743.
SUPPLEMENTARY INFORMATION:
DATES:
16:35 Jun 19, 2006
Jkt 208001
The Welch Causeway (SR 699) bridge,
Gulf Intracoastal Waterway mile 122.8,
Madeira Beach, Pinellas County, Florida
currently opens on signal; except that,
from 9:30 a.m. to 6 p.m. on Saturdays,
Sundays, and Federal holidays, the
draw need be opened only on the hour,
20 minutes after the hour, and 40
minutes after the hour. This bridge is in
close proximity to other bridges
currently under construction. The
bridge provides vehicular access on and
off the coastal barrier islands.
Florida State Representative Rice’s
office, on behalf of the citizens of
Madeira Beach, requested the Coast
Guard change the current operation of
the bridge to two openings per hour
during certain periods, while other
bridge construction projects were
underway. The bridge will be required
to only open on the hour and half-hour
Fridays from 2 p.m. until 6 p.m. and
Saturdays, Sundays and Federal
holidays from 10 a.m. until 6 p.m.
Public vessels of the United States, tugs
with tows and vessels in distress shall
be passed as necessary.
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
35391
Discussion of Rule
The regulation was requested by
Florida Representative Rice’s office on
behalf of the residents of Madeira Beach
and will provide temporary relief for
vehicular traffic while other bridge
construction projects are underway,
while continuing to provide for the
reasonable needs of navigation. The
bridge will be required to only open on
the hour and half-hour on Fridays from
2 p.m. until 6 p.m. and on Saturdays,
Sundays and Federal holidays from 10
a.m. until 6 p.m. The draw shall open
as necessary for the passage of tugs with
tows, public vessels of the United States
and vessels in distress.
Regulatory Evaluation
This rule is not a ‘‘significant
regulatory action’’ under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
Order. The Office of Management and
Budget has not reviewed it under that
Order. It is not ‘‘significant’’ under the
regulatory policies and procedures of
the Department of Homeland Security
(DHS). The Coast Guard expects the
economic impact of this rule to be so
minimal that a full Regulatory
Evaluation is unnecessary, because the
rule will allow for bridge openings
during the construction of nearby
bridges.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), we considered
whether this rule would have a
significant economic impact on a
substantial number of small entities.
The term ‘‘small entities’’ comprises
small businesses, not-for-profit
organizations that are independently
owned and operated and are not
dominant in their fields, and
governmental jurisdictions with
populations of less than 50,000.
The Coast Guard certifies under 5
U.S.C. 605(b) that this rule would not
have a significant economic impact on
a substantial number of small entities,
because the regulations provide for
bridge openings, and for the reasonable
needs of navigation.
Assistance for Small Entities
Under section 213(a) of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121),
we want to assist small entities in
understanding this rule so that they can
better evaluate its effects on them and
participate in the rulemaking process. If
this rule would affect your small
business, organization, or governmental
E:\FR\FM\20JNR1.SGM
20JNR1
]]>Agencies
[Federal Register Volume 71, Number 118 (Tuesday, June 20, 2006)]
[Rules and Regulations]
[Pages 35389-35391]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5432]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket No. DoD-2006-HA-0143]
RIN 0720-0057
Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS)/TRICARE; Coverage of Phase II and Phase III Clinical Trials
Sponsored by the National Institutes of Health National Cancer
Institute
AGENCY: Office of the Secretary, DoD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The final rule allows the Department of Defense to waive
normal requirements so that covered beneficiaries can participate in
Phase II and Phase III clinical trials sponsored or approved by the
National Institutes of Health National Cancer Institute (NIH NCI). This
waiver authority is expected to promote beneficiary access to promising
new treatments and contribute to the development of such treatments.
DATES: This rule is effective July 20, 2006.
ADDRESSES: TRICARE Management Activity (TMA), Medical Benefits and
Reimbursement System, 16301 East Centretech Parkway, Aurora, CO 80011-
9066
FOR FURTHER INFORMATION CONTACT: Debra Hatzel, Medical Benefits and
Reimbursement Systems, TMA, telephone (303) 676-3572. Questions
regarding payment of specific claims under TRICARE should be addressed
to the appropriate TRICARE contractor.
SUPPLEMENTARY INFORMATION:
I. Background
This final rule implements Title 10, United States Code, section
1079(a)(13) which provides for a waiver of the general prohibition on
coverage of unproven medical treatments or procedures in connection
with clinical trials sponsored or approved by the National Institutes
of Health National Cancer Institute. This waiver is contingent upon the
Secretary of Defense's determination that a waiver will promote access
to promising new treatments and contribute to the development of such
treatments. Based on the improved beneficiary access to these trials,
and the contributions to the development of such treatments, it is in
the best interest of the Department and its beneficiaries to continue
to provide access through an authorized waiver as outlined in the
proposed rule.
Clinical trials are the major avenue for discovering, developing,
and evaluating new cancer therapies, and clinical trial participants
are among the first to receive new cancer prevention or treatment
methods before they are widely available. Many significant medical
discoveries in this field have occurred as a direct result of clinical
trial participation. For example, because of survival improvements seen
in an NCI-sponsored clinical trial, early initiation of hormonal
therapy has become the standard of care in node-positive prostrate
cancer patients. Even when they do not lead to new therapies, clinical
trials often answer important questions and help move research forward
so that others may prevent or survive this disease.
Cancer treatment trials may include testing new drugs, new
approaches to surgery or radiation therapy, new combinations of
treatments, or new methods such as gene therapy. Studies that involve
drugs or invasive procedures are categorized by phase. Phase I trials
evaluate new cancer drugs to determine what dose is safe, how a new
agent should be administered (by mouth, injected into a vein, or
injected into the muscle), and how frequently the treatment should be
given. After safety parameters have been established, Phase II trials
are conducted to assess the effectiveness of an agent or intervention
against a specific type of cancer. Phase III trials compare effective
treatments from Phase II studies to conventional cancer treatments.
Clinical trials offer high quality care for cancer prevention and
treatment, and no patient ever receives a placebo (substance with
active ingredients) when effective care exists.
The Department of Defense (DoD) and the National Cancer Institute
(NCI) established a partnership in 1994 to conduct a demonstration
project that allowed patients with breast cancer to participate in NCI-
sponsored bone marrow transplant clinical trials. This demonstration
project expanded in 1996 to include all cancers and NCI-sponsored Phase
II and III cancer treatment clinical trials. The DoD-NCI demonstration
partnership was further
[[Page 35390]]
expanded on June 21, 1999 to include clinical trials related to
prevention, screening and early detection of cancer. Because of the
inherent safety risks and unproven clinical benefits associated with
toxicology studies, Phase I clinical trials were not included in this
demonstration.
Between January 1996 and July 2004, approximately 350 TRICARE
beneficiaries have participated in NCI-approved clinical trials
conducted in doctors' offices, community hospitals and clinics, cancer
centers, other medical centers, and veterans' and military hospitals
across the United States. Healthcare costs for the DoD-NCI
demonstration have ranged from $5.8 million to $16 million per year,
and research has indicated that patient-care costs associated with
cancer clinical trials are only slightly higher than the costs
associated with treating similar patients outside of trials.
The Department of Defense hopes that his permanent benefit will
heighten the awareness among our cancer patients that clinical trials
are a promising treatment option and encourage them to consider Phase
II and Phase III clinical trial participation. Participation in
clinical trials related to prevention, screening, and early detection
of cancer will contribute to the growing base of medical knowledge in
these areas and may lead to more effective treatments in the future.
Phase I trials will continue to be excluded from coverage; also,
TRICARE will continue to deny coverage for any items or services that
are already covered under the investigational protocol. Only those
supplies and services that TRICARE otherwise would have covered during
the normal course of treatment (to include costs for screening tests to
determine clinical trial eligibility) will be eligible for cost-
sharing. This continues the coverage policy which was previously
established for the DoD-NCI cancer trials demonstration.
This final rule was previously published in the Federal Register on
January 31, 2001 (66 FR 8365-8366). The rule was withdrawn on February
7, 2001 (66 FR 9199) because it was determined that it should not have
been published in accordance with the Regulatory Review Plan. We are
reissuing this final rule with only minor changes (``CHAMPUS'' changed
to ``TRICARE'' where appropriate; minor changes to paragraph numbers to
reflect current regulations); however, we are repeating the entire
final rule here for the benefit of the public.
II. Public Comments
The proposed rule was published in the Federal Register on May 31,
2000 (65 FR 34627). No public comments were received. The final rule is
consistent with the proposed rule.
III. Regulatory Procedures
Executive Order (EO) 12866 requires that a comprehensive regulatory
impact analysis be performed on any economically significant regulatory
action, defined as one which would result in an annual effect of $100
million or more on the national economy or which would have other
substantial impacts. This is not a significant regulatory action under
EO 12866 and has been reviewed by the Office of Manpower and Budget.
The Regulatory Flexibility Act (RFA) requires that each Federal
agency prepare, and make available for public comment, a regulatory
flexibility analysis when the agency issues a regulation which would
have a significant impact on a substantial number of small entities. We
certify that this final rule will not significantly affect a
substantial number of small entities.
This final rule will not impose additional information collection
requirements on the public under the Paperwork Reduction Act of 1995
(44 U.S.C. chapter 55).
List of Subjects in 32 CFR Part 199
Administrative practice and procedure, Claims, Fraud, Healthcare,
Health insurance, Military personnel.
0
Accordingly, 32 CFR part 199 is amended as follows:
PART 199--[AMENDED]
0
1. The authority citation for part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
0
2. Section 199.4 is amended by adding new paragraph (e)(26) and
revising paragraph (g)(15) introductory text to read as follows:
Sec. 199.4 Basic program benefits.
* * * * *
(e) * * *
(26) National Institutes of Health clinical trials. By law, the
general prohibition against CHAMPUS cost-sharing of unproven drugs,
devices, and medical treatments or procedures may be waived in
connection with clinical trials sponsored or approved by the National
Institutes of Health National Cancer Institute if it is determined that
such a waiver will promote access by covered beneficiaries to promising
new treatments and contribute to the development of such treatments. A
waiver shall only be exercised as authorized under this paragraph.
(i) Demonstration waiver. A waiver may be granted through a
demonstration project established in accordance with Sec. 199.1(o) of
this part.
(ii) Continuous waiver. (A) General. As a result of a demonstration
project under which a waiver has been granted in connection with a
National Institutes of Health National Cancer Institute clinical trial,
a determination may be made that it is in the best interest of the
government and CHAMPUS beneficiaries to end the demonstration and
continue to provide a waiver for CHAMPUS cost-sharing of the specific
clinical trial. Only those specified clinical trials identified under
paragraph (e)(26)(ii) of this section have been authorized a continuous
waiver under CHAMPUS.
(B) National Cancer Institute (NCI) sponsored cancer prevention,
screening, and early detection clinical trials. A continuous waiver
under paragraph (e)(26) of this regulation has been granted for CHAMPUS
cost-sharing for those CHAMPUS-eligible patients selected to
participate in NCI sponsored Phase II and Phase III studies for the
prevention and treatment of cancer.
(1) TRICARE will cost-share all medical care and testing required
to determine eligibility for an NCI-sponsored trial, including the
evaluation for eligibility at the institution conducting the NCI-
sponsored study. TRICARE will cost-share all medical care required as a
result of participation in NCI-sponsored studies. This includes
purchasing and administering all approved chemotherapy agents (except
for NCI-funded investigational drugs), all inpatient and outpatient
care, including diagnostic and laboratory services not otherwise
reimbursed under an NCI grant program if the following conditions are
met:
(i) The provider seeking treatment for a CHAMPUS-eligible patient
in an NCI approved protocol has obtained pre-authorization for the
proposed treatment before initial evaluation; and,
(ii) Such treatments are NCI sponsored Phase II or Phase III
protocols; and,
(iii) The patient continues to meet entry criteria for said
protocol; and,
(iv) The institutional and individual providers are CHAMPUS
authorized providers.
(2) TRICARE will not provide reimbursement for care rendered in the
National Institutes of Health Clinical
[[Page 35391]]
Center or costs associated with non-treatment research activities
associated with the clinical trials.
(3) Cost-shares and deductibles applicable to CHAMPUS will also
apply under the NCI-sponsored clinical trials.
(4) The Director, TRICARE (or designee), shall issue procedures and
guidelines establishing NCI-sponsorship of clinical trials and the
administrative process by which individual patients apply for and
receive cost-sharing under NCI-sponsored cancer clinical trials.
(g) * * *
(15) Unproven drugs, devices, and medical treatments or procedures.
By law, CHAMPUS can only cost-share medically necessary supplies and
services. Any drug, device, or medical treatment or procedure, the
safety and efficacy of which have not been established, as described in
this paragraph (g)(15), is unproved and cannot be cost-shared by
CHAMPUS except as authorized under paragraph 199.4(e)(26) of this part.
* * * * *
Dated: June 9, 2006.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 06-5432 Filed 6-19-06; 8:45 am]
BILLING CODE 5001-06-M
