Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Rules and Regulations 38177 

of the Social Security Act (42 U.S.C. 

1396, et seq.) through employment, by 

law, through membership in an 

organization, or as a student, or through 

the purchase of a private insurance or 

health plan, shall be recouped following 

the procedures in paragraph (f) of this 

section. If the other plan has not made 

payment to the beneficiary or provider, 

the contractor shall first attempt to 

recover the overpayment from the other 

plan through the contractor’s 

coordination of benefits procedures. If 

the overpayment cannot be recovered 

from the other plan, or if the other plan 

has made payment, the overpayment 

will be recovered from the party that 

received the erroneous payment from 

TRICARE. Nothing in this section shall 

be construed to require recoupment 

from any sponsor, beneficiary, provider, 

supplier and/or the Medicare Program 

under Title XVIII of the Social Security 

Act in the event of a retroactive 

determination of entitlement to SSDI 

and Medicare Part A coverage made by 

the Social Security Administration as 

discussed in § 199.8(d) of this part. 

* * * * * 

Dated: June 20, 2012. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2012–15508 Filed 6–26–12; 8:45 am] 

BILLING CODE 5001–06–P 

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. 

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 offlabel 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 offlabel 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 offlabel 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 


emcdonald on DSK67QTVN1PROD with RULES
38178 Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Rules and Regulations 

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] 

■ 1. The authority citation for part 199 

continues to read as follows: 

Authority: 5 U.S.C. 301; 10 U.S.C. chapter 

55. 

■ 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: 

§ 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. 

* * * * * 

■ 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: 

§ 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 § 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 


emcdonald on DSK67QTVN1PROD with RULES