Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Proposed Rules 44797 

rulemaking, effective on August 31, 

2009. 

Authority and Signature. 

Megan Uzzell, 

Acting Assistant Secretary for Policy. 

[FR Doc. E9–20923 Filed 8–28–09; 8:45 am] 

BILLING CODE 4510–23–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, and Medical 

Treatments or Procedures 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: The Department of Defense is 

publishing this proposed rule to revise 

the definition of ‘‘unlabeled or off-label 

drug’’ to ‘‘off-label use of a drug or 

device.’’ This revision is consistent with 

the regulatory framework under the 

Federal Food, Drug, and Cosmetic Act. 

Additionally, this rule removes the 

partial list of examples of unproven 

drugs, devices, and medical treatments 

or procedures proscribed in TRICARE 

regulations. As it is determined that 

reliable evidence demonstrates that 

previously unproven drugs, devices, 

and medical treatments or procedures 

have proven medical effectiveness, 

TRICARE has removed them from the 

list and authorized medically necessary 

care. This revision removing the partial 

list is necessary as the list will never be 

completely current, and is only a partial 

list of examples. The removal of this 

partial list does not change or eliminate 

any benefits that are currently available 

under the TRICARE program. 

DATES: Written comments received at 

the address indicated below by October 

30, 2009 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number and/or 

Regulatory Information Number (RIN) 

number and title, by either of the 

following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 1160 Defense Pentagon, 

Washington, DC 20301–1160. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: 

Rene ́ L. Morrell, TRICARE Management 

Activity, Medical Benefits and 

Reimbursement Branch, telephone (303) 

676–3618. 

SUPPLEMENTARY INFORMATION: This 

proposed rule revises the definition of 

‘‘unlabeled or off-label drug’’ to ‘‘offlabel use of a drug or device.’’ This 

revision is consistent with the 

regulatory framework under the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq.). Additionally, this proposed 

rule removes the partial list of examples 

of unproven drugs, devices, and medical 

treatments or procedures proscribed 

under § 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’’ to be consistent with 

the regulatory framework under the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 301 et seq.) 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 is reliable 

evidence, as defined in section 199.2, 

sufficient to establish that the off-label 

use is safe, 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. 

Partial List of Examples of Unproven 

Drugs, Devices, and Medical 

Treatments or Procedures 

By law, TRICARE can only cost-share 

medically necessary supplies and 

services. Any drug, device, and medical 

treatment or procedure, the safety and 

efficacy of which have not been 

established, as described in 

§ 199.4(g)(15), is unproven and cannot 

be cost-shared by TRICARE except as 

authorized under § 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. 

Regulatory Procedures 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ 

Section 801 of Title 5, U.S.C., and 

Executive Order (E.O.) 12866 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 E.O. 12866. 

Sec. 202, Public Law 104–4, ‘‘Unfunded 

Mandates Reform Act’’ 

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. 


sroberts on DSKD5P82C1PROD with PROPOSALS
44798 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Proposed Rules 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (5 U.S.C. 601) 

The Regulatory Flexibility Act (RFA) 

requires 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. 

This proposed rule will not significantly 

affect 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 significant 

additional information collection 

requirements on the public under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3511). Existing information 

collection requirements of the TRICARE 

and Medicare programs will be utilized. 

Executive Order 13132, ‘‘Federalism’’ 

This proposed rule has been 

examined for its impact under E.O. 

13132 and it 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 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 

proposed to be amended as follows: 

PART 199—[AMENDED] 

1. The authority citation for 32 CFR 

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 drug or device is legally 

marketed under the Federal Food, Drug, 

and Cosmetic Act. This includes any 

use that is not included in the approved 

labeling for an approved drug or 

approved device; 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 Section 199.2(b). 

Approval for reimbursement of off-label uses 

requires review for medical necessity, and 

also requires demonstrations from reliable 

evidence, as defined in § 199.2, that the offlabel use of the drug or device is safe, 

effective and in accordance with nationally 

accepted standards of practice in the medical 

community. 

* * * * * 

Dated: August 21, 2009. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. E9–20683 Filed 8–28–09; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DoD–2009–HA–0094] 

RIN 0720–AB32 

TRICARE; Diabetic Education 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: The Department of Defense is 

publishing this proposed rule to clarify 

TRICARE coverage for diabetic 

education. This rule introduces new 

definitions and addresses revisions or 

omissions in policy or procedure 

inadvertently missed in previous 

regulatory changes pertaining to 

diabetic education. 

DATES: Written comments received at 

the address indicated below by October 

30, 2009 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number or 

Regulatory Information Number (RIN) 

and title, by either of the following 

methods: 

The Web site: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Mail: Federal Docket Management 

System Office, Room 3C843 Pentagon, 

1160 Defense Pentagon, Washington, DC 

20301–1160. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: Joy 

Saly, Medical Benefits and 

Reimbursement Branch, TRICARE 

Management Activity, telephone (303) 

676–3742. Questions regarding payment 

of specific claims should be addressed 

to the appropriate TRICARE contractor. 

SUPPLEMENTARY INFORMATION: This 

proposed rule introduces new 

definitions and addresses revisions or 

omissions in policy or procedure 

inadvertently missed in previous 

regulatory changes pertaining to 

diabetic education. 

Diabetes self-management training is 

an interactive, collaborative process 

involving beneficiaries with diabetes, 

their physician(s) and their educators. 

The educational process should provide 

the beneficiary with the knowledge and 

skills needed to perform self-care, 

manage crises, and make lifestyle 

changes required to manage the diabetes 

successfully. 

TRICARE had previously classified 

diabetes self-management training as a 

counseling service that was not 

medically necessary. Since all services 

provided under the TRICARE program 

must be medically necessary and 

appropriate, diabetes self-management 

training was excluded from coverage. In 

developing the TRICARE policy on selfmanagement, however, it was 

determined that diabetes educational 

services are consistent with the 

medically necessary and appropriate 

provision and it was decided to conform 

with Medicare’s policy on diabetes selfmanagement training. As such, 

TRICARE removed ‘‘diabetic selfVerDate Nov<24>2008 16:24 Aug 28, 2009 Jkt 217001 PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 E:\FR\FM\31AUP1.SGM 31AUP1

sroberts on DSKD5P82C1PROD with PROPOSALS