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[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Rules and Regulations]
[Pages 38177-38178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15510]

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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[DOD-2008-HA-0090]
RIN 0720-AB23

TRICARE; Off-Label Uses of Devices; Partial List of Examples of 
Unproven Drugs, Devices, Medical Treatments, or Procedures

AGENCY: Office of the Secretary, Department of Defense (DoD).

ACTION: Final rule.

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SUMMARY: The Department of Defense is publishing this final rule to 
revise the definition of ``unlabeled or off-label drug'' to ``off-label 
use of a drug or device.'' This provision codifies the coverage of 
those medically necessary indications for which there are 
demonstrations from medical literature, national organizations, or 
technology assessment bodies that the off-label use is safe and 
effective and in accordance with nationally accepted standards of 
practice in the medical community. Additionally, this rule removes the 
partial list of examples of unproven drugs, devices, and medical 
treatments or procedures proscribed in TRICARE regulations. We are 
removing the partial list from the regulation but will maintain the 
partial list in the TRICARE Policy Manual at www.tricare.mil.

DATES: Effective Date: This rule is effective July 27, 2012.

FOR FURTHER INFORMATION CONTACT: Ms. Elan Green, TRICARE Management 
Activity, Medical Benefits and Reimbursement Branch, telephone (303) 
676-3907.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of August 31, 2009 (74 FR 44797-44798), the 
Office of the Secretary of Defense published for public comment a 
proposed rule that revised the definition of ``unlabeled or off-label 
drug'' to ``off-label use of a drug or device.'' In addition this 
proposed rule removed the partial list of examples of unproven drugs, 
devices, and medical treatments or procedures proscribed under Section 
199.4(g)(15).

Off-Label Uses of Devices

    On January 6, 1997, the Office of the Secretary of Defense 
published a final rule in the Federal Register (62 FR 627-631) 
clarifying the TRICARE exclusion of unproven drugs, devices, and 
medical treatments or procedures and adding the TRICARE definition of 
unlabeled or off-label drugs. This rule also added the provision for 
coverage of unlabeled or off-label uses of drugs that are Food and Drug 
Administration (FDA) approved drugs that are prescribed or administered 
by a health care practitioner and are used for indications or 
treatments not included in the approved labeling. We are now modifying 
the definition of ``unlabeled or off-label drug'' to ``off-label use of 
a drug or device,'' which includes a drug, biologic or device under the 
regulatory authority of the FDA. However, this proposed rule does not 
present new agency policy. Rather, it corrects an error and omission 
from the current rule. Coverage is limited to those indications for 
which there are demonstrations from medical literature, national 
organizations, or technology assessment bodies that the off-label use 
is safe and effective and in accordance with nationally accepted 
standards of practice in the medical community. In addition, the off-
label use must be reviewed for medical necessity.
    In general, good medical practice and the best interests of the 
patient require that physicians use legally available drugs, biologics, 
and devices, including combination products, according to their best 
knowledge and judgment. When providers use a product for an indication 
not in the approved labeling, they have a responsibility to be well 
informed about the product, to base its use on firm scientific 
rationale and on sound medical evidence. Limiting CHAMPUS cost-sharing 
to those off-label uses for which there are demonstrations from medical 
literature, national organizations, or technology assessment bodies 
that the off-label use is safe, effective, and in accordance with 
nationally accepted standards of practice in the medical community will 
help to ensure there is sufficient scientific evidence supporting the 
off-label use, without being overly onerous, while still promoting 
innovations in medical practice that benefit patients.
    In reviewing the proposed rule, we discovered that we had 
inadvertently incorporated the TRICARE reliable evidence standard (as 
defined in 32 CFR 199.2) as the threshold for reviewing coverage for 
off-label or unlabeled use. The intent was not to make the standard of 
review more onerous but rather to expand the application of the 
existing provision regarding the cost-sharing of off-label use of drugs 
to also include the off-label use of devices and biologics. As a 
result, we are withdrawing the changes to the third paragraph of the 
Note to paragraph (g)(15)(i)(A) in section 199.4 with the exception of 
replacing the term ``unlabeled or off-label uses of drugs'' with ``off-
label uses of drugs and devices,'' with an appropriate reference back 
to the definition of the term in 199.2. ``Off-label uses of drugs and 
devices'' includes off-label uses of drugs, biologics, devices, and 
combination products.
    Although most biological products meet the definition of ``drugs'' 
under the Federal Food, Drug and Cosmetic Act, and are also regulated 
under that law, biological products are approved for marketing under 
the Public Health Services Act by means of a biologics license 
application. Thus, the definition of ``off-label use of a drug or 
device'' has been revised to acknowledge both the Federal Food, Drug 
and Cosmetic Act and the Public Health Services Act as sources of the 
FDA's regulatory authority over the marketing of these products.

Partial List of Examples of Unproven Drugs, Devices, and Medical 
Treatments or Procedures

    By law, TRICARE can cost-share only medically necessary supplies 
and services. Any drug, device, and medical treatment or procedure, the 
safety and efficacy of which have not been

[[Page 38178]]

established, as described in Part 199.4(g)(15), is unproven and cannot 
be cost-shared by TRICARE except as authorized under paragraph 
199.4(e)(26). The current regulation and program policy provide a 
partial list of examples of unproven drugs, devices, and medical 
treatments or procedures that are excluded from benefits. The intent of 
this partial list was to provide information on specific examples of 
emerging drugs, devices, and medical treatments or procedures 
determined to be unproven by TRICARE based on review of current 
reliable evidence. Due to the rapid and extensive changes in medical 
technology it is not feasible to maintain this list in the regulation. 
Removal of this partial list of examples does not change the exclusion 
of unproven drugs, devices, and medical treatments or procedures. 
Removal of the partial list of examples does not change the process 
TRICARE follows in determining for purposes of benefit coverage when a 
drug, device, and medical treatment or procedure has moved from the 
status of unproven to proven medical effectiveness. The intent of this 
revision is to ensure that benefit determinations are made based on 
current reliable evidence rather than relying on outdated regulatory 
and policy provisions. A partial list of unproven drugs, devices, 
medical treatments, or procedures will continue to be published in the 
TRICARE Policy Manual at www.tricare.mil.

II. Public Comments

    We provided a 60-day public comment period following publication of 
the Proposed Rule in the Federal Register (74 FR 44797-44798) on August 
31, 2009. We received no public comments.

III. Regulatory Procedures

Executive Order 12866, ``Regulatory Planning and Review'' and Executive 
Order 13563, ``Improving Regulation and Regulatory Review''

    Section 801 of title 5, United States Code, and Executive Orders 
12866 and 13563 require certain regulatory assessments and procedures 
for any major rule or significant regulatory action, defined as one 
that would result in an annual effect of $100 million or more on the 
national economy or which would have other substantial impacts. It has 
been certified that this rule is not an economically significant rule; 
however, it is a regulatory action which has been reviewed by the 
Office of Management and Budget as required under the provisions of EOs 
12866 and 13563.

Section 202, Public Law 104-4, ``Unfunded Mandates Reform Act''

    Section 202 of Public Law 104-4, ``Unfunded Mandates Reform Act,'' 
requires that an analysis be performed to determine whether any federal 
mandate may result in the expenditure by State, local and tribal 
governments, in the aggregate, or by the private sector of $100 million 
in any one year. It has been certified that this rule does not contain 
a Federal mandate that may result in the expenditure by State, local 
and tribal governments, in aggregate, or by the private sector, of $100 
million or more in any one year.

Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. 601)

    The ``Regulatory Flexibility Act'' (RFA) requires each Federal 
agency to 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. 
This rule will not significantly impact a substantial number of small 
entities for purposes of the RFA.

Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)

    This rule will not impose additional information collection 
requirements on the public under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3511).

Executive Order 13132, ``Federalism''

    This rule has been examined for its impact under E.O. 13132 and 
does not contain policies that have federalism implications that would 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government; 
therefore, consultation with the State and local officials is not 
required.

List of Subjects in 32 CFR Part 199

    Claims, Dental health, Health care, Health insurance, Individuals 
with disabilities, Military personnel.

    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 199.2(b) is amended by removing the definition of 
``Unlabeled or Off-label drugs'' and adding a new definition of ``Off-
label use of a drug or device'' in alphabetical order to read as 
follows:

Sec.  199.2  Definitions.

* * * * *
    (b) * * *
* * * * *
    Off-label use of a drug or device. A use other than an intended use 
for which the prescription drug, biologic or device is legally marketed 
under the Federal Food, Drug, and Cosmetic Act or the Public Health 
Services Act. This includes any use that is not included in the 
approved labeling for an approved drug, licensed biologic, approved 
device or combination product; any use that is not included in the 
cleared statement of intended use for a device that has been determined 
by the Food and Drug Administration (FDA) to be substantially 
equivalent to a legally marketed predicate device and cleared for 
marketing; and any use of a device for which a manufacturer or 
distributor would be required to seek pre-market review by the FDA in 
order to legally include that use in the device's labeling.
* * * * *

0
3. Section 199.4 is amended by revising the third paragraph of the Note 
to paragraph (g)(15)(i)(A), and removing paragraph (g)(15)(iv) as 
follows:

Sec.  199.4  Basic program benefits.

* * * * *
    (g) * * *
    (15) * * *
    (i) * * *
    (A) * * *
    Note: * * *
    CHAMPUS will consider coverage of off-label uses of drugs and 
devices that meet the definition of Off-Label Use of a Drug or Device 
in Sec.  199.2(b). Approval for reimbursement of off-label uses 
requires review for medical necessity and also requires demonstrations 
from medical literature, national organizations, or technology 
assessment bodies that the off-label use of the drug or device is safe, 
effective, and in accordance with nationally accepted standards of 
practice in the medical community.
* * * * *

    Dated: June 20, 2012.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2012-15510 Filed 6-26-12; 8:45 am]
BILLING CODE 5001-06-P
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