80_FR_44412 80 FR 44269 - Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: TRICARE Pharmacy Benefits Program

80 FR 44269 - Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: TRICARE Pharmacy Benefits Program

DEPARTMENT OF DEFENSE
Office of the Secretary

Federal Register Volume 80, Issue 143 (July 27, 2015)

Page Range44269-44274
FR Document2015-18290

This final rule implements new authority for an over-the- counter (OTC) drug program, makes several administrative changes to the TRICARE Pharmacy Benefits Program regulation in order to conform it to the statute, and clarifies some procedures regarding the operation of the uniform formulary. Specifically, the final rule: Provides implementing regulations for the OTC drug program that has recently been given permanent statutory authority; conforms the pharmacy program regulation to the statute (including recent statutory changes contained in the Carl Levin and Howard P. ``Buck'' McKeon National Defense Authorization Act for Fiscal Year 2015) regarding point-of-service availability of non-formulary drugs and copayments for all categories of drugs; clarifies the process for formulary placement of newly approved drugs; and clarifies several other uniform formulary practices.

Federal Register, Volume 80 Issue 143 (Monday, July 27, 2015)
[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Rules and Regulations]
[Pages 44269-44274]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18290]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[Docket ID: DOD-2012-HA-0049]
RIN 0720-AB57


Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS)/TRICARE: TRICARE Pharmacy Benefits Program

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

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule implements new authority for an over-the-
counter (OTC) drug program, makes several administrative changes to the 
TRICARE Pharmacy Benefits Program regulation in order to conform it to 
the statute, and clarifies some procedures regarding the operation of 
the uniform formulary. Specifically, the final rule: Provides 
implementing regulations for the OTC drug program that has recently 
been given permanent statutory authority; conforms the pharmacy program 
regulation to the statute (including recent statutory changes contained 
in the Carl Levin and Howard P. ``Buck'' McKeon National Defense 
Authorization Act for Fiscal Year 2015) regarding point-of-service 
availability of non-formulary drugs and copayments for all categories 
of drugs; clarifies the process for formulary placement of newly 
approved drugs; and clarifies several other uniform formulary 
practices.

DATES: This final rule is effective August 26, 2015.

FOR FURTHER INFORMATION CONTACT: Dr. George E. Jones, Jr., Chief, 
Pharmacy Operations Division, Defense Health Agency, telephone 703-681-
2890.

SUPPLEMENTARY INFORMATION:

A. Executive Summary

1. Purpose of Regulatory Action

    The final rule is necessary to incorporate new statutory authority 
for a permanent OTC program, make several administrative changes to the 
TRICARE Pharmacy Benefits Program regulation to conform to the statute 
(10 U.S.C. 1074g), and clarify some procedures regarding the uniform 
formulary.
    Legal authority for this final rule is 10 U.S.C. 1074g.

2. Summary of the Final Rule

    a. It establishes the process for identifying select OTC products 
for coverage under the pharmacy benefit program and the rules for 
making these products available to eligible DoD beneficiaries under the 
new authority enacted in section 702 of the National Defense 
Authorization Act for Fiscal Year 2013 (NDAA-13). In general, approved 
OTC pharmaceuticals will comply with the mandatory generic policy as 
stated in 32 CFR 199.21(j)(2) and will be available under terms similar 
to generic prescription medications, except that the need for a 
prescription and/or a copay may be waived in some circumstances.
    b. It conforms the regulation to the statute regarding the point of 
service where non-formulary drugs are available. They would be 
generally available in the mail order program, except that if validated 
as medically necessary, they would be available from military treatment 
facility pharmacies and from retail pharmacies (at the formulary copay 
level) as well.
    c. It clarifies the process for formulary placement of newly 
approved innovator drugs brought to market under a New Drug Application 
approved by the Food and Drug Administration (FDA), giving the Pharmacy 
and Therapeutics Committee up to 120 days to recommend tier placement 
on the uniform formulary. During this period, new drugs would be 
assigned a classification pending status; they would be available under 
terms comparable to non-formulary drugs, unless medically necessary, in 
which case they would be available under terms comparable to formulary 
drugs.
    d. As a ``housekeeping'' change, it conforms the rule to the new 
statutory specifications for copayment amounts in 10 U.S.C 1074g.

3. Costs and Benefits

    The benefits of this final rule are that it will more closely 
conform the regulation to the statute and facilitate more effective 
administration of the

[[Page 44270]]

TRICARE Pharmacy Benefits Program. The final rule will provide savings 
to the Department of a low-end estimate of $18.4 million and the high-
end estimate of $26 million per year based on OTC program savings and 
estimated potential savings resulting from being able to offer non-
formulary drugs through the most cost-effective venue. Revenue from 
implementation of copay changes resulting from statutory changes 
contained in the Carl Levin and Howard P. ``Buck'' McKeon National 
Defense Authorization Act for Fiscal Year 2015 is a low end estimate of 
$183.1 million annually and a high end estimate for $198.7 million 
annually. With respect to these statutory changes, this rule simply 
makes ``housekeeping'' amendments to conform to the specific statutory 
requirements. DoD has no administrative discretion on this matter.

B. Background

    In 1999, Congress enacted 10 U.S.C. 1074g to, among other things, 
establish a uniform formulary program to incentivize the use of more 
cost-effective pharmaceutical agents and points of service. There are 
four points of service under the Pharmacy Benefits Program--military 
facility pharmacies, retail network pharmacies, retail non-network 
pharmacies, and the TRICARE mail order pharmacy program (TMOP)--and 
three uniform formulary tiers--First Tier for generic drugs, Second 
Tier for preferred brand name drugs (also referred to as ``formulary 
drugs''), and Third Tier for non-preferred brand name drugs (also 
referred to as ``non-formulary drugs''). In addition to establishing 
procedures for assigning drugs to one of the three tiers, the statute 
includes several other specifications, including that formulary drugs 
are generally available in all three points of service. Until very 
recently, the statute also provided that non-formulary drugs would be 
available in at least one point of service. TRICARE's regulations 
implementing this statute, issued in 2004, established or continued 
prior rules for, among other things: Assigning drugs to a formulary 
tier based on clinical and cost-effectiveness, and point of service 
availability for the respective tiers. Although the statute required 
Third Tier drugs to be available in only one point of service, the 
regulations made them available in two. Under section 702 of the Carl 
Levin and Howard P. ``Buck'' McKeon National Defense Authorization Act 
for Fiscal Year 2015 (NDAA-15), non-formulary drugs are now generally 
limited to the mail order pharmacy point of service (unless there is a 
validated medical necessity for the drug).
    TRICARE's administration of the Pharmacy Benefits Program has 
achieved some improvements in cost-effectiveness through the retail 
refund program, increased utilization of formulary management tools 
such as step-therapy and prior authorizations, and increased copays. 
The final rule will provide savings to the Department of a low-end 
estimate of $18.4 million and the high-end estimate of $26 million per 
year based on a combination of the savings from the current OTC 
demonstration program and estimated potential savings resulting from 
being able to offer non-formulary drugs through the most cost-effective 
venue. Revenue from implementation of copay changes resulting from 
statutory changes contained in the Carl Levin and Howard P. ``Buck'' 
McKeon National Defense Authorization Act for Fiscal Year 2015 is a low 
end estimate of $183.1 million annually and a high end estimate for 
$198.7 million annually. As a ``housekeeping'' matter, this rule 
includes the necessary changes to conform to the new statutory 
specifications over which DoD has no administrative discretion. 
However, overall costs of the TRICARE Pharmacy Benefits Program have 
continued to increase substantially, from approximately $2 billion in 
fiscal year 2001, to approximately $7 billion for fiscal year 2012. 
Like other large health plans, DoD is experiencing rising pharmacy 
costs due to new expensive products, shorter hospital stays, and in 
some cases higher drug prices. DoD also has an expanded beneficiary 
population, which now includes ``TRICARE-for-Life'' beneficiaries and 
some members of the Selected Reserves and their families. Retail 
prescription co-payments reflect the cost for up to a 30-day supply of 
the prescription, while mail order co-payments cover up to a 90-day 
supply. This difference is part of the incentive for beneficiaries to 
use the more cost-effective mail order program, as is the recent 
elimination of copayments for mail order generic drugs. Encouraging 
increased use of DoD's more cost-effective points of service (i.e., the 
mail order pharmacy or a military treatment facility pharmacy) and more 
cost-effective pharmaceutical products (i.e., those on First Tier and 
Second Tier) continues to be a TRICARE program objective.

C. Summary of the Final Rule

    This final rule establishes the process for selecting OTC products 
for coverage under the TRICARE pharmacy benefits program and would 
provide the guidelines for making selected OTC products available to 
eligible DoD beneficiaries. The OTC drugs demonstration project began 
through the TRICARE Mail Order Pharmacy program in May 2007 and in the 
TRICARE Retail Pharmacy program in October 2007. Due to the brevity of 
the demonstration, particularly in the retail pharmacy venue, in June 
2009 an interim report to Congress was submitted with preliminary cost 
savings estimates and positive beneficiary feedback. In order to 
validate the initial results and identify areas for improvement to the 
program, the Department of Defense (DoD) extended the program through a 
Federal Register notice published on December 16, 2009. The 
demonstration program was due to terminate November 4, 2012. The DoD 
extended the OTC demonstration for another 2 years through publishing a 
Federal Register notice, while awaiting permanent legislative 
authority. A report to Congress in 2012 stated that DoD saved 
approximately $62M during the course of the OTC demo. Section 702 of 
NDAA-13 amended subsection (a)(2) of section 1074g of title 10, United 
States Code, providing permanent authority to place selected over-the-
counter drugs on the uniform formulary.
    The new legislation authorizes DoD to place selected OTC drugs on 
the uniform formulary and make such drugs available to eligible covered 
beneficiaries (eligibility specified in 32 CFR 199.3). The basic 
criteria regarding selection of OTC products for consideration are 
cost-effectiveness and patient access. DoD will consider and approve an 
OTC drug for inclusion in the uniform formulary only if it is expected 
to reduce government costs relative to a clinically comparable 
alternative drug that would otherwise be consumed and/or if an OTC 
product provided access to care not otherwise met by prescription-only 
products (e.g., Plan B contraceptive). An OTC drug may be included on 
the uniform formulary only if the Pharmacy and Therapeutics (P&T) 
Committee finds that the OTC drug is both cost effective and clinically 
effective. Clinical effectiveness is judged by the criteria found in 32 
CFR 199.21(e)(1)(i-ii) while cost effectiveness is determined based on 
criteria found in 32 CFR 199.21(e)(2). This cost-effectiveness standard 
is reinforced by the requirement for physician supervision through 
issuance of a prescription for the OTC drug. This requirement applies 
unless it is waived based on a recommendation of the Pharmacy and 
Therapeutics Committee for the use of the drug for certain medical 
situations, such as emergency care treatment.

[[Page 44271]]

    The selected OTC drugs would be placed in First Tier with the 
corresponding copays applicable to the point-of-service involved. 
Alternatively, based on the recommendation of the Pharmacy and 
Therapeutics Committee and approval of the Director, DHA, the retail 
copay may be waived and $0.00 copay established for the particular OTC 
drug in all points of service. No cost sharing is required at any of 
the three points of service for a uniformed service member on active 
duty.
    This final rule also makes several administrative changes to the 
TRICARE Pharmacy Benefits Program regulation to conform more closely to 
the statute (10 U.S.C. 1074g) and to clarify some procedures regarding 
the uniform formulary. One change aligns the regulation with the 
statute regarding the point of service where non-formulary drugs are 
generally available. Until very recently, the statute required 
availability in one of the three primary points of service (military 
facility, retail network, and mail order program). The current 
regulation specifies that non-formulary (Third Tier) drugs are 
generally unavailable in military facilities and generally available in 
the retail network and by mail order. The proposed rule would have 
revised this to state that non-formulary drugs would generally be 
available in the retail network or by mail order, but the Pharmacy and 
Therapeutics Committee could recommend and the DHA Director could 
approve limiting the drug to only one venue based on determinations 
that there is no significant clinical need and there is a significant 
additional government cost for access to both venues. However, since 
publication of the proposed rule, Congress has amended the statute to 
specify that non-formulary drugs will only be generally available in 
the mail order program. This removes any DoD discretion on the matter. 
Therefore, this final rule states that non-formulary drugs are 
generally available only in the mail order program. It should be noted 
that existing statutory and regulatory provisions allowing an exception 
to this in cases of medical necessity for the non-formulary drug remain 
in effect. Therefore, when medically necessary, non-formulary drugs are 
available at military treatment facility pharmacies and also from 
retail pharmacies. In the latter case, the copay will be the same as is 
applicable to formulary drugs.
    This change will reinforce DoD policy, which encourages use of more 
cost-effective drugs and points of service. A beneficiary always has 
the option of asking the health care provider to change the 
prescription to a comparable formulary drug, or, in cases of medical 
necessity, obtaining approval for dispensing the non-formulary drug at 
the formulary copayment amount. Like all other health plans with 
formularies, physicians make professional decisions regarding formulary 
alternatives, often in consultation with the pharmacist in light of the 
individual patient's circumstances. Under DoD's policy, when a 
physician provides written justification stating why the non-preferred 
drug is expected to have better clinical outcomes than the preferred 
drug, the non-formulary drug may be obtained at the formulary copay. 
This process is clearly explained to the provider by the Pharmacy 
Benefit manager through telephone or fax when the situation occurs. 
Another option for most prescriptions when the beneficiary prefers a 
non-formulary drug is to have the prescription transferred to the mail 
order program, which has a lower co-payment for a 90-day supply of a 
non-formulary drug ($46) than the retail point of service would have 
for three 30-day prescriptions for a formulary drug (3 times $20).
    Another administrative change in this final rule clarifies the 
process for formulary placement of innovator drugs newly approved by 
the Food and Drug Administration. Current practice for brand name drugs 
is that they are placed in the Second Tier the day FDA approves the 
drug. This practice has not led to the most cost-effective placement of 
these newly approved drugs and has the potential for confusion among 
patients and physicians if the drug is soon thereafter moved to Third 
Tier. DoD proposes that newly approved drugs be evaluated for their 
relative clinical benefit and relative cost, as compared to other drugs 
in the same class, at the next quarterly meeting of the Pharmacy and 
Therapeutics (P&T) Committee following FDA approval. A recommendation 
will then be made to the Director of the Defense Health Agency for tier 
placement of the drug.
    The current statute and regulation do not specifically address the 
status of the drug from the date of FDA approval to the date the P&T 
Committee's recommendation is eventually implemented. This final rule 
addresses this by considering the newly approved drug to be in a 
classification pending status and covered by TRICARE under terms 
applicable to Third Tier drugs, and by providing a period of up to 120 
days for the P&T Committee to make a final determination with respect 
to formulary classification. Tier classification will normally occur at 
the next quarterly meeting following FDA approval, but in cases when 
the FDA approval happens too close to a scheduled meeting for the 
necessary research to be done, the drug would be considered at the 
following meeting. The 120-day time period accommodates this. During 
the period prior to a decision on tier placement, the newly approved 
drug will be covered by TRICARE under Third Tier terms.
    Under the current rule, new drugs are immediately placed on the 
Second Tier (formulary brand-name drugs). Once the new drug is properly 
reviewed and compared to all other drugs in its class, it is often 
moved to the Third Tier (non-formulary), i.e., no clinical or cost 
advantage. Under this final rule, very briefly deferring tier placement 
pending a review would not require a ``tier move'' if the review finds 
no clinical or cost advantage. Movement of drugs between the tiers is 
always confusing to beneficiaries even though they are notified in 
writing of the change. The change to the rule will lessen the 
likelihood of a tier move for the new product.
    This final rule also incorporates into the regulation several 
details of current practice. While the current regulation provides that 
a uniform formulary drug that is not a generic drug may be grouped for 
copayment purposes with generic drugs if it is judged to be as cost 
effective as generic drugs in the same drug class, this final rule adds 
that a generic drug may be classified as non-formulary if it is less 
cost-effective than non-generic formulary drugs in the same drug class. 
The Uniform Formulary process requires the P&T committee to make 
recommendations to the Director, Defense Health Agency who approves or 
disapproves each recommendation after reviewing comments from the 
Beneficiary Advisory Panel on the recommendations. In the case of all 
generic drugs, the beneficiary copayment amount for any prescription 
may not exceed the total charge to TRICARE for that prescription.
    Finally, this final rule makes a ``housekeeping'' change to the 
paragraph on cost sharing amounts to make it conform to the current 
statutory specifications established by NDAA-13 and NDAA-15. In the 
current regulation, copays were calculated based on the previous 
statute that stated that the Third Tier copay could be no more than 20% 
for active duty dependents or 25% for retirees and their dependents of 
the cost of the drug. The NDAA-13 legislation provided specific set 
dollar amounts for copays from January 2014 through January 2023. NDAA-
15 adjusted several of these amounts by $3 per prescription and

[[Page 44272]]

generally eliminated availability of non-formulary drugs at the retail 
pharmacy point of service. This has rendered the text of the current 
regulation out of date and no longer accurate. The new text of the 
regulation matches the current statutory specifications. The final rule 
also reissues without change paragraphs (h)(4) and (i)(2)(ii)(D) to 
clarify agency intent and correct a technical misstatement in a 2011 
Federal Register publication.

D. Summary of and Response to Public Comments

    The proposed rule was published in the Federal Register (79 FR 
56312) September 19, 2014, for a 60-day comment period. We received 
three comments on the proposed rule from three commenters. We 
appreciate these comments, which are summarized here, along with DoD's 
response.
    Comment: One comment expressed concern regarding limiting the 
availability of non-formulary pharmaceuticals to one point of service 
based on Pharmacy and Therapeutics Committee recommendations and 
approval by the Director, Defense Health Agency. The commenter's 
concern was specific to limiting the availability of compounded 
medications to one point of service.
    Response: This final rule is not addressing compounded medications 
and the rule is doing nothing more that conforming with the current 
statutory specification (based on NDAA-15) that non-formulary drugs are 
generally only available through the mail order point of service. 
(Existing regulatory provisions at 32 CFR 199.21(h)(3)(iv) stating that 
with validated medical necessity, non-formulary drugs are provided at 
formulary drug copays remain in effect.)
    Comment: One commenter objected to the proposed rule provision that 
newly approved drugs will be maintained for a brief administrative 
review period in a ``classification pending'' status and be available 
under terms comparable to Third Tier drugs. The commenter expressed the 
view that this is contrary to the statute, which establishes the 
default position for brand name drugs at the Second Tier, and could 
impair prompt access to important new drugs.
    Response: DoD believes this change does not conflict with the 
statute, which does not address the issue of status pending the first 
opportunity of the Pharmacy and Therapeutics Committee to consider the 
appropriate tier placement of the drug. TRICARE is trying to minimize 
the beneficiary confusion associated with tier changes. This 
administrative review period is very short. It will last not more than 
120 days, and often a shorter period. And perhaps most importantly, in 
any case in which there is a validated medical necessity for the newly 
approved drug, it will be available on the same terms as apply to Tier 
Two drugs. Thus, DoD is adopting this brief administrative review 
period for initial tier placement of newly approved brand name drugs.
    Comment: One commenter expressed support for the proposed 
provisions on over-the-counter drugs, but recommended that a preamble 
summary of the provision and inclusion of an example of emergency 
contraception be written into the regulatory text.
    Response: DoD acknowledges the commenter's agreement with the 
policy, but sees no need to revise the regulatory language. It 
correctly states the intended policy, and providing an example of a 
particular drug DoD expects to be covered by that policy is more 
appropriate for a preamble summary than regulatory text.

E. Regulatory Procedures

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

    Executive Order (EO) 12866 and 13563 require that a comprehensive 
regulatory impact analysis be performed on any economically significant 
regulatory action, defined primarily as one that would result in an 
effect of $100 million or more in any one year. The DoD has examined 
the economic, legal, and policy implications of this final rule and has 
concluded that it is not an economically significant regulatory action 
under Section 3(f)(1) of the EO. The rule has been reviewed by the 
Office of Management and Budget.

Congressional Review Act, 5 U.S.C. 801, et seq.

    Under the Congressional Review Act, a major rule may not take 
effect until at least 60 days after submission to Congress of a report 
regarding the rule. A major rule is one that would have an annual 
effect on the economy of $100 million or more or have certain other 
impacts. For this purpose we note that the budget savings identified in 
this preamble are mostly associated with ``housekeeping'' changes to 
the Code of Federal Regulations to conform to specific statutory 
requirements, with respect to which DoD has no administrative 
discretion.

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

    This rule does not contain a Federal mandate that may result in the 
expenditure by State, local and tribunal governments, in aggregate, or 
by the private sector, of $100 million or more (adjusted for inflation) 
in any one year.

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

    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. 
This final rule does not have a significant impact on a substantial 
number of small entities.

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

    This final rule contains no new information collection requirements 
subject to the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-
3511).

Executive Order 13132, ``Federalism''

    This final rule does not have federalism implications, as set forth 
in Executive Order 13132. This rule does not have substantial direct 
effects on the States; the relationship between the National Government 
and the States; or the distribution of power and responsibilities among 
the various levels of Government.

List of Subjects in 32 CFR Part 199

    Claims, Health care, Health insurance, Military personnel, Pharmacy 
Benefits.

    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 199.21 is amended by:
0
a. Adding paragraph (b)(3));
0
b. Adding paragraph (g)(5);
0
c. Revising paragraphs (h)(3)(i) and (ii);
0
d. Republishing paragraph (h)(4);
0
e. Adding paragraph (h)(5);
0
f. Revising paragraphs (i)(2)(ii) through (v), and (i)(2)(x); and
0
g. Adding paragraphs (i)(2)(xii) and (j)(4) and (5).
    The additions and revisions read as follows:


Sec.  199.21  TRICARE Pharmacy Benefits Program.

* * * * *
    (b) * * *
    (3) Over-the-counter drug. A drug that is not subject to section 
503(b)(1) of the

[[Page 44273]]

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)).
* * * * *
    (g) * * *
    (5) Administrative procedure for newly approved drugs. In the case 
of a newly approved innovator drug, other than a generic drug, the 
innovator drug will, not later than 120 days after the date of approval 
by the Food and Drug Administration, be added to the uniform formulary 
unless prior to that date the P&T Committee has recommended that the 
agent be listed as a non-formulary drug. If the Director, DHA 
subsequently approves that recommendation, the drug will be so listed. 
If the Director, DHA disapproves the recommendation to list the drug as 
non-formulary Third Tier, the drug will be then classified per the 
Director's decision. If, prior to the expiration of 120 days, the P&T 
Committee recommends that the agent be added to the uniform formulary 
and the recommendation is approved by the Director, DHA, that will be 
done as soon as feasible. Pending action under this paragraph (g)(5), 
the newly approved pharmaceutical agent will be considered to be in a 
classification pending status and will be available to beneficiaries 
under Third Tier terms applicable to all other non-formulary agents.
* * * * *
    (h) * * *
    (3) Availability of non-formulary pharmaceutical agents.--(i) 
General. Non-formulary pharmaceutical agents are generally not 
available in military treatment facilities or in the retail point of 
service. They are available in the mail order program.
    (ii) Availability of non-formulary pharmaceutical agents at 
military treatment facilities. Even when particular non-formulary 
agents are not generally available at military treatment facilities, 
they will be made available to eligible covered beneficiaries through 
the non-formulary special approval process as noted in this paragraph 
(h)(3)(ii) when there is a valid medical necessity for use of the non-
formulary pharmaceutical agent.
* * * * *
    (4) Availability of vaccines/immunizations. A retail network 
pharmacy may be an authorized provider under the Pharmacy Benefits 
Program when functioning within the scope of its state laws to provide 
authorized vaccines/immunizations to an eligible beneficiary. The 
Pharmacy Benefits Program will cover the vaccine and its administration 
by the retail network pharmacy, including administration by pharmacists 
who meet the applicable requirements of state law to administer the 
vaccine. A TRICARE authorized vaccine/immunization includes only 
vaccines/immunizations authorized as preventive care under the basic 
program benefits of Sec.  199.4 of this part, as well as such care 
authorized for Prime enrollees under the uniform HMO benefit of Sec.  
199.18. For Prime enrollees under the uniform HMO benefit, a referral 
is not required under paragraph (n)(2) of Sec.  199.18 for preventive 
care vaccines/immunizations received from a retail network pharmacy 
that is a TRICARE authorized provider. Any additional policies, 
instructions, procedures, and guidelines appropriate for implementation 
of this benefit may be issued by the TMA Director.
    (5) Availability of selected over-the-counter (OTC) drugs under the 
pharmacy benefits program. Although the pharmacy benefits program 
generally covers only prescription drugs, in some cases over-the-
counter drugs may be covered and may be placed on the uniform 
formulary.
    (i) An OTC drug may be included on the uniform formulary upon the 
recommendation of the Pharmacy and Therapeutics Committee and approval 
of the Director, DHA, based on a finding that it is cost-effective and 
clinically effective, as compared with other drugs in the same 
therapeutic class of pharmaceutical agents. Clinical need is judged by 
the criteria found in paragraph (e)(1)(i) and (ii) of this section. 
Cost effectiveness is determined based on criteria found in paragraph 
(e)(2) of this section.
    (ii) OTC drugs placed on the uniform formulary, in general, will be 
treated the same as generic drugs on the uniform formulary for purposes 
of availability in MTF pharmacies, retail pharmacies, and the mail 
order pharmacy program and other requirements. However, upon the 
recommendation of the Pharmacy and Therapeutics Committee and approval 
of the Director, DHA, the requirement for a prescription may be waived 
for a particular OTC drug for certain emergency care treatment 
situations. In addition, a special copayment may be established under 
paragraph (i)(2)(xii) of this section for OTC drugs specifically used 
in certain emergency care treatment situations.
    (i) * * *
    (2) * * *
    (ii) For pharmaceutical agents obtained from a retail network 
pharmacy there is a:
    (A) $20.00 co-payment per prescription required for up to a 30-day 
supply of a formulary pharmaceutical agent.
    (B) $8.00 co-payment per prescription for up to a 30-day supply of 
a generic pharmaceutical agent.
    (C) $0.00 co-payment for vaccines/immunizations authorized as 
preventive care for eligible beneficiaries.
    (iii) For formulary and generic pharmaceutical agents obtained from 
a retail non-network pharmacy there is a 20 percent or $20.00 co-
payment (whichever is greater) per prescription for up to a 30-day 
supply of the pharmaceutical agent.
    (iv) For pharmaceutical agents obtained under the TRICARE mail-
order program there is a:
    (A) $16.00 co-payment per prescription for up to a 90-day supply of 
a formulary pharmaceutical agent.
    (B) $0.00 co-payment for up to a 90-day supply of a generic 
pharmaceutical agent.
    (C) $46.00 co-payment for up to a 90-day supply of a non-formulary 
pharmaceutical agent. (D) $ 0.00 co-payment for smoking cessation 
pharmaceutical agents covered under the smoking cessation program.
* * * * *
    (x) The per prescription co-payments established in this paragraph 
(i)(2) may be adjusted periodically based on experience with the 
uniform formulary, changes in economic circumstances, and other 
appropriate factors. Any such adjustment must be approved by the 
Assistant Secretary of Defense (Health Affairs). These additional 
requirements apply:
    (A) Beginning January 1, 2016, the amounts specified in this 
paragraph (i)(2) shall be increased annually by the percentage increase 
in the cost-of-living adjustment by which retired pay is increased 
under 10 U.S. Code section 1401a for the year, rounded down to the 
nearest dollar. However, with respect to any amount of increase that is 
less than $1 or any amount lost in rounding down to the nearest dollar, 
that amount shall be carried over to, and accumulated with, the amount 
of the increase for the subsequent year or years and made when the 
aggregate amount of increases carried over for a year is $1 or more.
    (B) Effective January 1, 2023 (unless otherwise provided by law), 
the Assistant Secretary of Defense for Health Affairs may adjust the 
amounts specified in this paragraph (i)(2) as considered appropriate. 
Between January 1, 2016, and January 1, 2023, the only adjustments 
allowed are the cost of living adjustments described in paragraph 
(i)(2)(x)(A) of this section, unless otherwise provided by law.
* * * * *
    (xii) Special copayment rule for OTC drugs in the retail pharmacy 
network.

[[Page 44274]]

As a general rule, OTC drugs placed on the uniform formulary under 
paragraph (h)(5) of this section will have copayments equal to those 
for generic drugs on the uniform formulary. However, upon the 
recommendation of the Pharmacy and Therapeutics Committee and approval 
of the Director, DHA, the copayment may be established at $0.00 for any 
particular OTC drug in the retail pharmacy network.
    (j) * * *
    (4) Upon the recommendation of the Pharmacy and Therapeutics 
Committee, a generic drug may be classified as non-formulary if it is 
less cost effective than non-generic formulary drugs in the same drug 
class.
    (5) The beneficiary copayment amount for any generic drug 
prescription may not exceed the total charge for that prescription.
* * * * *

    Dated: July 21, 2015.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2015-18290 Filed 7-24-15; 8:45 am]
 BILLING CODE 5001-06-P



                                                                Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Rules and Regulations                                            44269

                                            14, 2008), the Consumer Product Safety                   § 1120.4 Standards incorporated by                    A. Executive Summary
                                            Commission amends 16 CFR part 1120                       reference.
                                                                                                                                                           1. Purpose of Regulatory Action
                                            to read as follows:                                      *     *    *     *   *
                                                                                                       (c) * * *                                              The final rule is necessary to
                                            PART 1120—SUBSTANTIAL PRODUCT                              (4) UL 817, Standard for Cord Sets                  incorporate new statutory authority for
                                            HAZARD LIST                                              and Power-Supply Cords, 11th Edition,                 a permanent OTC program, make
                                                                                                     dated March 16, 2001, as revised                      several administrative changes to the
                                            ■ 1. The authority citation for part 1120                                                                      TRICARE Pharmacy Benefits Program
                                                                                                     through February 3, 2014 (‘‘UL 817’’),
                                            continues to read as follows:                                                                                  regulation to conform to the statute (10
                                                                                                     IBR approved for § 1120.3(d).
                                                Authority: 15 U.S.C. 2064(j).                                                                              U.S.C. 1074g), and clarify some
                                                                                                       Dated: July 22, 2015.
                                            ■ 2. In § 1120.2, add paragraph (e) to                                                                         procedures regarding the uniform
                                                                                                     Todd A. Stevenson,
                                            read as follows:                                                                                               formulary.
                                                                                                     Secretary, Consumer Product Safety                       Legal authority for this final rule is 10
                                            § 1120.2    Definitions.                                 Commission.                                           U.S.C. 1074g.
                                                                                                     [FR Doc. 2015–18294 Filed 7–24–15; 8:45 am]
                                            *      *    *      *    *                                                                                      2. Summary of the Final Rule
                                               (e) Extension cord (also known as a                   BILLING CODE 6355–01–P

                                            cord set) means a length of factory-                                                                              a. It establishes the process for
                                            assembled flexible cord with an                                                                                identifying select OTC products for
                                            attachment plug or current tap as a line                                                                       coverage under the pharmacy benefit
                                                                                                     DEPARTMENT OF DEFENSE                                 program and the rules for making these
                                            fitting and with a cord connector as a
                                            load fitting. Extension cords are used for                                                                     products available to eligible DoD
                                                                                                     Office of the Secretary                               beneficiaries under the new authority
                                            extending a branch circuit supply of an
                                            electrical outlet to the power-supply                                                                          enacted in section 702 of the National
                                                                                                     32 CFR Part 199                                       Defense Authorization Act for Fiscal
                                            cord of a portable appliance, in
                                            accordance with the National Electrical                                                                        Year 2013 (NDAA–13). In general,
                                                                                                     [Docket ID: DOD–2012–HA–0049]                         approved OTC pharmaceuticals will
                                            Code.® For purposes of this rule, the
                                            term applies to extension cords that are                                                                       comply with the mandatory generic
                                                                                                     RIN 0720–AB57                                         policy as stated in 32 CFR 199.21(j)(2)
                                            equipped with National Electrical
                                            Manufacturer Association (‘‘NEMA’’) 1–                                                                         and will be available under terms
                                                                                                     Civilian Health and Medical Program of
                                            15, 5–15 and 5–20 fittings, and that are                                                                       similar to generic prescription
                                                                                                     the Uniformed Services (CHAMPUS)/
                                            intended for indoor use only, or for both                                                                      medications, except that the need for a
                                                                                                     TRICARE: TRICARE Pharmacy
                                            indoor and outdoor use. The term                                                                               prescription and/or a copay may be
                                                                                                     Benefits Program
                                            ‘‘extension cord’’ does not include                                                                            waived in some circumstances.
                                            detachable power supply cords,                           AGENCY:  Office of the Secretary,                        b. It conforms the regulation to the
                                            appliance cords, power strips and taps,                  Department of Defense (DoD).                          statute regarding the point of service
                                            and adaptor cords supplied with                          ACTION: Final rule.                                   where non-formulary drugs are
                                            outdoor tools and yard equipment.                                                                              available. They would be generally
                                            ■ 3. In § 1120.3, add paragraph (d) to                   SUMMARY:    This final rule implements                available in the mail order program,
                                            read as follows:                                         new authority for an over-the-counter                 except that if validated as medically
                                                                                                     (OTC) drug program, makes several                     necessary, they would be available from
                                            § 1120.3 Products deemed to be                           administrative changes to the TRICARE                 military treatment facility pharmacies
                                            substantial product hazards.                             Pharmacy Benefits Program regulation                  and from retail pharmacies (at the
                                            *      *     *     *     *                               in order to conform it to the statute, and            formulary copay level) as well.
                                               (d) Extension cords that lack one or                  clarifies some procedures regarding the                  c. It clarifies the process for formulary
                                            more of the following specified                          operation of the uniform formulary.                   placement of newly approved innovator
                                            characteristics in conformance with                      Specifically, the final rule: Provides                drugs brought to market under a New
                                            requirements in sections 2, 9, 16, 19, 20,               implementing regulations for the OTC                  Drug Application approved by the Food
                                            21, 26, 30, 31, 32, 84, and 105 of UL 817                drug program that has recently been                   and Drug Administration (FDA), giving
                                            (incorporated by reference, see                          given permanent statutory authority;                  the Pharmacy and Therapeutics
                                            § 1120.4):                                               conforms the pharmacy program                         Committee up to 120 days to
                                               (1) Minimum wire size requirement in                  regulation to the statute (including                  recommend tier placement on the
                                            sections 2, 20, 21, and 30 of UL 817;                    recent statutory changes contained in                 uniform formulary. During this period,
                                               (2) Sufficient strain relief requirement              the Carl Levin and Howard P. ‘‘Buck’’                 new drugs would be assigned a
                                            in sections 20, 30, and 84 of UL 817;                    McKeon National Defense Authorization                 classification pending status; they
                                               (3) Proper polarization requirement in                Act for Fiscal Year 2015) regarding                   would be available under terms
                                            sections 9, 19, 20, 30, 31, and 32 of UL                 point-of-service availability of non-                 comparable to non-formulary drugs,
                                            817;                                                     formulary drugs and copayments for all                unless medically necessary, in which
                                               (4) Proper continuity requirement in                  categories of drugs; clarifies the process            case they would be available under
                                            sections 16, 20, 30, and 105 of UL 817;                  for formulary placement of newly                      terms comparable to formulary drugs.
                                               (5) Outlet cover requirement (for                     approved drugs; and clarifies several                    d. As a ‘‘housekeeping’’ change, it
                                            indoor 2-wire parallel extension cords                   other uniform formulary practices.                    conforms the rule to the new statutory
                                            with polarized parallel-blade and -slot                                                                        specifications for copayment amounts in
                                            fittings) in sections 20 and 26 of UL 817;               DATES: This final rule is effective August
                                                                                                                                                           10 U.S.C 1074g.
tkelley on DSK3SPTVN1PROD with RULES




                                            or                                                       26, 2015.
                                               (6) Jacketed cord requirement (for                    FOR FURTHER INFORMATION CONTACT: Dr.                  3. Costs and Benefits
                                            outdoor use extension cords) in section                  George E. Jones, Jr., Chief, Pharmacy                    The benefits of this final rule are that
                                            30 of UL 817.                                            Operations Division, Defense Health                   it will more closely conform the
                                            ■ 4. In § 1120.4, add paragraph (c)(4) to                Agency, telephone 703–681–2890.                       regulation to the statute and facilitate
                                            read as follows:                                         SUPPLEMENTARY INFORMATION:                            more effective administration of the


                                       VerDate Sep<11>2014   16:00 Jul 24, 2015   Jkt 235001   PO 00000   Frm 00019   Fmt 4700   Sfmt 4700   E:\FR\FM\27JYR1.SGM   27JYR1


                                            44270               Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Rules and Regulations

                                            TRICARE Pharmacy Benefits Program.                          TRICARE’s administration of the                    beneficiaries. The OTC drugs
                                            The final rule will provide savings to                   Pharmacy Benefits Program has                         demonstration project began through the
                                            the Department of a low-end estimate of                  achieved some improvements in cost-                   TRICARE Mail Order Pharmacy program
                                            $18.4 million and the high-end estimate                  effectiveness through the retail refund               in May 2007 and in the TRICARE Retail
                                            of $26 million per year based on OTC                     program, increased utilization of                     Pharmacy program in October 2007. Due
                                            program savings and estimated potential                  formulary management tools such as                    to the brevity of the demonstration,
                                            savings resulting from being able to offer               step-therapy and prior authorizations,                particularly in the retail pharmacy
                                            non-formulary drugs through the most                     and increased copays. The final rule                  venue, in June 2009 an interim report to
                                            cost-effective venue. Revenue from                       will provide savings to the Department                Congress was submitted with
                                            implementation of copay changes                          of a low-end estimate of $18.4 million                preliminary cost savings estimates and
                                            resulting from statutory changes                         and the high-end estimate of $26                      positive beneficiary feedback. In order
                                            contained in the Carl Levin and Howard                   million per year based on a combination               to validate the initial results and
                                            P. ‘‘Buck’’ McKeon National Defense                      of the savings from the current OTC                   identify areas for improvement to the
                                            Authorization Act for Fiscal Year 2015                   demonstration program and estimated                   program, the Department of Defense
                                            is a low end estimate of $183.1 million                  potential savings resulting from being                (DoD) extended the program through a
                                            annually and a high end estimate for                     able to offer non-formulary drugs                     Federal Register notice published on
                                            $198.7 million annually. With respect to                 through the most cost-effective venue.                December 16, 2009. The demonstration
                                            these statutory changes, this rule simply                Revenue from implementation of copay                  program was due to terminate
                                            makes ‘‘housekeeping’’ amendments to                     changes resulting from statutory                      November 4, 2012. The DoD extended
                                            conform to the specific statutory                        changes contained in the Carl Levin and               the OTC demonstration for another 2
                                            requirements. DoD has no                                 Howard P. ‘‘Buck’’ McKeon National                    years through publishing a Federal
                                            administrative discretion on this matter.                Defense Authorization Act for Fiscal                  Register notice, while awaiting
                                                                                                     Year 2015 is a low end estimate of                    permanent legislative authority. A
                                            B. Background
                                                                                                     $183.1 million annually and a high end                report to Congress in 2012 stated that
                                               In 1999, Congress enacted 10 U.S.C.                   estimate for $198.7 million annually. As              DoD saved approximately $62M during
                                            1074g to, among other things, establish                  a ‘‘housekeeping’’ matter, this rule                  the course of the OTC demo. Section
                                            a uniform formulary program to                           includes the necessary changes to                     702 of NDAA–13 amended subsection
                                            incentivize the use of more cost-                        conform to the new statutory                          (a)(2) of section 1074g of title 10, United
                                            effective pharmaceutical agents and                      specifications over which DoD has no                  States Code, providing permanent
                                            points of service. There are four points                 administrative discretion. However,                   authority to place selected over-the-
                                            of service under the Pharmacy Benefits                   overall costs of the TRICARE Pharmacy                 counter drugs on the uniform formulary.
                                            Program—military facility pharmacies,                    Benefits Program have continued to
                                            retail network pharmacies, retail non-                                                                            The new legislation authorizes DoD to
                                                                                                     increase substantially, from
                                            network pharmacies, and the TRICARE                                                                            place selected OTC drugs on the
                                                                                                     approximately $2 billion in fiscal year
                                            mail order pharmacy program (TMOP)—                                                                            uniform formulary and make such drugs
                                                                                                     2001, to approximately $7 billion for
                                            and three uniform formulary tiers—First                                                                        available to eligible covered
                                                                                                     fiscal year 2012. Like other large health
                                            Tier for generic drugs, Second Tier for                  plans, DoD is experiencing rising                     beneficiaries (eligibility specified in 32
                                            preferred brand name drugs (also                         pharmacy costs due to new expensive                   CFR 199.3). The basic criteria regarding
                                            referred to as ‘‘formulary drugs’’), and                 products, shorter hospital stays, and in              selection of OTC products for
                                            Third Tier for non-preferred brand name                  some cases higher drug prices. DoD also               consideration are cost-effectiveness and
                                            drugs (also referred to as ‘‘non-                        has an expanded beneficiary                           patient access. DoD will consider and
                                            formulary drugs’’). In addition to                       population, which now includes                        approve an OTC drug for inclusion in
                                            establishing procedures for assigning                    ‘‘TRICARE-for-Life’’ beneficiaries and                the uniform formulary only if it is
                                            drugs to one of the three tiers, the                     some members of the Selected Reserves                 expected to reduce government costs
                                            statute includes several other                           and their families. Retail prescription               relative to a clinically comparable
                                            specifications, including that formulary                 co-payments reflect the cost for up to a              alternative drug that would otherwise be
                                            drugs are generally available in all three               30-day supply of the prescription, while              consumed and/or if an OTC product
                                            points of service. Until very recently,                  mail order co-payments cover up to a                  provided access to care not otherwise
                                            the statute also provided that non-                      90-day supply. This difference is part of             met by prescription-only products (e.g.,
                                            formulary drugs would be available in at                 the incentive for beneficiaries to use the            Plan B contraceptive). An OTC drug
                                            least one point of service. TRICARE’s                    more cost-effective mail order program,               may be included on the uniform
                                            regulations implementing this statute,                   as is the recent elimination of                       formulary only if the Pharmacy and
                                            issued in 2004, established or continued                 copayments for mail order generic                     Therapeutics (P&T) Committee finds
                                            prior rules for, among other things:                     drugs. Encouraging increased use of                   that the OTC drug is both cost effective
                                            Assigning drugs to a formulary tier                      DoD’s more cost-effective points of                   and clinically effective. Clinical
                                            based on clinical and cost-effectiveness,                service (i.e., the mail order pharmacy or             effectiveness is judged by the criteria
                                            and point of service availability for the                a military treatment facility pharmacy)               found in 32 CFR 199.21(e)(1)(i–ii) while
                                            respective tiers. Although the statute                   and more cost-effective pharmaceutical                cost effectiveness is determined based
                                            required Third Tier drugs to be available                products (i.e., those on First Tier and               on criteria found in 32 CFR 199.21(e)(2).
                                            in only one point of service, the                        Second Tier) continues to be a TRICARE                This cost-effectiveness standard is
                                            regulations made them available in two.                  program objective.                                    reinforced by the requirement for
                                            Under section 702 of the Carl Levin and                                                                        physician supervision through issuance
                                            Howard P. ‘‘Buck’’ McKeon National                       C. Summary of the Final Rule                          of a prescription for the OTC drug. This
tkelley on DSK3SPTVN1PROD with RULES




                                            Defense Authorization Act for Fiscal                       This final rule establishes the process             requirement applies unless it is waived
                                            Year 2015 (NDAA–15), non-formulary                       for selecting OTC products for coverage               based on a recommendation of the
                                            drugs are now generally limited to the                   under the TRICARE pharmacy benefits                   Pharmacy and Therapeutics Committee
                                            mail order pharmacy point of service                     program and would provide the                         for the use of the drug for certain
                                            (unless there is a validated medical                     guidelines for making selected OTC                    medical situations, such as emergency
                                            necessity for the drug).                                 products available to eligible DoD                    care treatment.


                                       VerDate Sep<11>2014   16:00 Jul 24, 2015   Jkt 235001   PO 00000   Frm 00020   Fmt 4700   Sfmt 4700   E:\FR\FM\27JYR1.SGM   27JYR1


                                                                Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Rules and Regulations                                           44271

                                               The selected OTC drugs would be                       comparable formulary drug, or, in cases               approval, but in cases when the FDA
                                            placed in First Tier with the                            of medical necessity, obtaining approval              approval happens too close to a
                                            corresponding copays applicable to the                   for dispensing the non-formulary drug                 scheduled meeting for the necessary
                                            point-of-service involved. Alternatively,                at the formulary copayment amount.                    research to be done, the drug would be
                                            based on the recommendation of the                       Like all other health plans with                      considered at the following meeting.
                                            Pharmacy and Therapeutics Committee                      formularies, physicians make                          The 120-day time period accommodates
                                            and approval of the Director, DHA, the                   professional decisions regarding                      this. During the period prior to a
                                            retail copay may be waived and $0.00                     formulary alternatives, often in                      decision on tier placement, the newly
                                            copay established for the particular OTC                 consultation with the pharmacist in                   approved drug will be covered by
                                            drug in all points of service. No cost                   light of the individual patient’s                     TRICARE under Third Tier terms.
                                            sharing is required at any of the three                  circumstances. Under DoD’s policy,                       Under the current rule, new drugs are
                                            points of service for a uniformed service                when a physician provides written                     immediately placed on the Second Tier
                                            member on active duty.                                   justification stating why the non-                    (formulary brand-name drugs). Once the
                                               This final rule also makes several                    preferred drug is expected to have better             new drug is properly reviewed and
                                            administrative changes to the TRICARE                    clinical outcomes than the preferred                  compared to all other drugs in its class,
                                            Pharmacy Benefits Program regulation                     drug, the non-formulary drug may be                   it is often moved to the Third Tier (non-
                                            to conform more closely to the statute                   obtained at the formulary copay. This                 formulary), i.e., no clinical or cost
                                            (10 U.S.C. 1074g) and to clarify some                    process is clearly explained to the                   advantage. Under this final rule, very
                                            procedures regarding the uniform                         provider by the Pharmacy Benefit                      briefly deferring tier placement pending
                                            formulary. One change aligns the                         manager through telephone or fax when                 a review would not require a ‘‘tier
                                            regulation with the statute regarding the                the situation occurs. Another option for              move’’ if the review finds no clinical or
                                            point of service where non-formulary                     most prescriptions when the beneficiary               cost advantage. Movement of drugs
                                            drugs are generally available. Until very                prefers a non-formulary drug is to have               between the tiers is always confusing to
                                            recently, the statute required availability              the prescription transferred to the mail              beneficiaries even though they are
                                            in one of the three primary points of                    order program, which has a lower co-                  notified in writing of the change. The
                                            service (military facility, retail network,              payment for a 90-day supply of a non-                 change to the rule will lessen the
                                            and mail order program). The current                     formulary drug ($46) than the retail                  likelihood of a tier move for the new
                                            regulation specifies that non-formulary                  point of service would have for three 30-             product.
                                            (Third Tier) drugs are generally                         day prescriptions for a formulary drug                   This final rule also incorporates into
                                            unavailable in military facilities and                   (3 times $20).                                        the regulation several details of current
                                            generally available in the retail network                   Another administrative change in this              practice. While the current regulation
                                            and by mail order. The proposed rule                     final rule clarifies the process for                  provides that a uniform formulary drug
                                            would have revised this to state that                    formulary placement of innovator drugs                that is not a generic drug may be
                                            non-formulary drugs would generally be                   newly approved by the Food and Drug                   grouped for copayment purposes with
                                            available in the retail network or by                    Administration. Current practice for                  generic drugs if it is judged to be as cost
                                            mail order, but the Pharmacy and                         brand name drugs is that they are placed              effective as generic drugs in the same
                                            Therapeutics Committee could                             in the Second Tier the day FDA                        drug class, this final rule adds that a
                                            recommend and the DHA Director could                     approves the drug. This practice has not              generic drug may be classified as non-
                                            approve limiting the drug to only one                    led to the most cost-effective placement              formulary if it is less cost-effective than
                                            venue based on determinations that                       of these newly approved drugs and has                 non-generic formulary drugs in the same
                                            there is no significant clinical need and                the potential for confusion among                     drug class. The Uniform Formulary
                                            there is a significant additional                        patients and physicians if the drug is                process requires the P&T committee to
                                            government cost for access to both                       soon thereafter moved to Third Tier.                  make recommendations to the Director,
                                            venues. However, since publication of                    DoD proposes that newly approved                      Defense Health Agency who approves or
                                            the proposed rule, Congress has                          drugs be evaluated for their relative                 disapproves each recommendation after
                                            amended the statute to specify that non-                 clinical benefit and relative cost, as                reviewing comments from the
                                            formulary drugs will only be generally                   compared to other drugs in the same                   Beneficiary Advisory Panel on the
                                            available in the mail order program.                     class, at the next quarterly meeting of               recommendations. In the case of all
                                            This removes any DoD discretion on the                   the Pharmacy and Therapeutics (P&T)                   generic drugs, the beneficiary
                                            matter. Therefore, this final rule states                Committee following FDA approval. A                   copayment amount for any prescription
                                            that non-formulary drugs are generally                   recommendation will then be made to                   may not exceed the total charge to
                                            available only in the mail order                         the Director of the Defense Health                    TRICARE for that prescription.
                                            program. It should be noted that existing                Agency for tier placement of the drug.                   Finally, this final rule makes a
                                            statutory and regulatory provisions                         The current statute and regulation do              ‘‘housekeeping’’ change to the
                                            allowing an exception to this in cases of                not specifically address the status of the            paragraph on cost sharing amounts to
                                            medical necessity for the non-formulary                  drug from the date of FDA approval to                 make it conform to the current statutory
                                            drug remain in effect. Therefore, when                   the date the P&T Committee’s                          specifications established by NDAA–13
                                            medically necessary, non-formulary                       recommendation is eventually                          and NDAA–15. In the current
                                            drugs are available at military treatment                implemented. This final rule addresses                regulation, copays were calculated
                                            facility pharmacies and also from retail                 this by considering the newly approved                based on the previous statute that stated
                                            pharmacies. In the latter case, the copay                drug to be in a classification pending                that the Third Tier copay could be no
                                            will be the same as is applicable to                     status and covered by TRICARE under                   more than 20% for active duty
                                            formulary drugs.                                         terms applicable to Third Tier drugs,                 dependents or 25% for retirees and their
tkelley on DSK3SPTVN1PROD with RULES




                                               This change will reinforce DoD                        and by providing a period of up to 120                dependents of the cost of the drug. The
                                            policy, which encourages use of more                     days for the P&T Committee to make a                  NDAA–13 legislation provided specific
                                            cost-effective drugs and points of                       final determination with respect to                   set dollar amounts for copays from
                                            service. A beneficiary always has the                    formulary classification. Tier                        January 2014 through January 2023.
                                            option of asking the health care provider                classification will normally occur at the             NDAA–15 adjusted several of these
                                            to change the prescription to a                          next quarterly meeting following FDA                  amounts by $3 per prescription and


                                       VerDate Sep<11>2014   16:00 Jul 24, 2015   Jkt 235001   PO 00000   Frm 00021   Fmt 4700   Sfmt 4700   E:\FR\FM\27JYR1.SGM   27JYR1


                                            44272               Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Rules and Regulations

                                            generally eliminated availability of non-                days, and often a shorter period. And                 expenditure by State, local and tribunal
                                            formulary drugs at the retail pharmacy                   perhaps most importantly, in any case                 governments, in aggregate, or by the
                                            point of service. This has rendered the                  in which there is a validated medical                 private sector, of $100 million or more
                                            text of the current regulation out of date               necessity for the newly approved drug,                (adjusted for inflation) in any one year.
                                            and no longer accurate. The new text of                  it will be available on the same terms as
                                                                                                                                                           Public Law 96–354, ‘‘Regulatory
                                            the regulation matches the current                       apply to Tier Two drugs. Thus, DoD is
                                            statutory specifications. The final rule                 adopting this brief administrative                    Flexibility Act’’ (5 U.S.C. 601)
                                            also reissues without change paragraphs                  review period for initial tier placement                The Regulatory Flexibility Act (RFA)
                                            (h)(4) and (i)(2)(ii)(D) to clarify agency               of newly approved brand name drugs.                   requires that each Federal agency
                                            intent and correct a technical                              Comment: One commenter expressed                   prepare and make available for public
                                            misstatement in a 2011 Federal Register                  support for the proposed provisions on                comment, a regulatory flexibility
                                            publication.                                             over-the-counter drugs, but                           analysis when the agency issues a
                                                                                                     recommended that a preamble summary                   regulation which would have a
                                            D. Summary of and Response to Public                     of the provision and inclusion of an
                                            Comments                                                                                                       significant impact on a substantial
                                                                                                     example of emergency contraception be                 number of small entities. This final rule
                                               The proposed rule was published in                    written into the regulatory text.                     does not have a significant impact on a
                                            the Federal Register (79 FR 56312)                          Response: DoD acknowledges the                     substantial number of small entities.
                                            September 19, 2014, for a 60-day                         commenter’s agreement with the policy,
                                            comment period. We received three                        but sees no need to revise the regulatory             Public Law 96–511, ‘‘Paperwork
                                            comments on the proposed rule from                       language. It correctly states the intended            Reduction Act’’ (44 U.S.C. Chapter 35)
                                            three commenters. We appreciate these                    policy, and providing an example of a                   This final rule contains no new
                                            comments, which are summarized here,                     particular drug DoD expects to be                     information collection requirements
                                            along with DoD’s response.                               covered by that policy is more                        subject to the Paperwork Reduction Act
                                               Comment: One comment expressed                        appropriate for a preamble summary                    (PRA) of 1995 (44 U.S.C. 3501–3511).
                                            concern regarding limiting the                           than regulatory text.
                                            availability of non-formulary                                                                                  Executive Order 13132, ‘‘Federalism’’
                                            pharmaceuticals to one point of service                  E. Regulatory Procedures
                                                                                                                                                             This final rule does not have
                                            based on Pharmacy and Therapeutics                       Executive Order 12866, ‘‘Regulatory                   federalism implications, as set forth in
                                            Committee recommendations and                            Planning and Review’’ and Executive                   Executive Order 13132. This rule does
                                            approval by the Director, Defense Health                 Order 13563, ‘‘Improving Regulation                   not have substantial direct effects on the
                                            Agency. The commenter’s concern was                      and Regulatory Review’’                               States; the relationship between the
                                            specific to limiting the availability of                    Executive Order (EO) 12866 and                     National Government and the States; or
                                            compounded medications to one point                      13563 require that a comprehensive                    the distribution of power and
                                            of service.                                              regulatory impact analysis be performed               responsibilities among the various
                                               Response: This final rule is not                                                                            levels of Government.
                                                                                                     on any economically significant
                                            addressing compounded medications
                                                                                                     regulatory action, defined primarily as
                                            and the rule is doing nothing more that                                                                        List of Subjects in 32 CFR Part 199
                                                                                                     one that would result in an effect of
                                            conforming with the current statutory                    $100 million or more in any one year.                   Claims, Health care, Health insurance,
                                            specification (based on NDAA–15) that                    The DoD has examined the economic,                    Military personnel, Pharmacy Benefits.
                                            non-formulary drugs are generally only                   legal, and policy implications of this
                                            available through the mail order point of                                                                        Accordingly, 32 CFR part 199 is
                                                                                                     final rule and has concluded that it is               amended as follows:
                                            service. (Existing regulatory provisions                 not an economically significant
                                            at 32 CFR 199.21(h)(3)(iv) stating that                  regulatory action under Section 3(f)(1)               PART 199—[AMENDED]
                                            with validated medical necessity, non-                   of the EO. The rule has been reviewed
                                            formulary drugs are provided at                          by the Office of Management and                       ■ 1. The authority citation for part 199
                                            formulary drug copays remain in effect.)                 Budget.                                               continues to read as follows:
                                               Comment: One commenter objected to
                                            the proposed rule provision that newly                   Congressional Review Act, 5 U.S.C. 801,                 Authority: 5 U.S.C. 301; 10 U.S.C. chapter
                                                                                                                                                           55.
                                            approved drugs will be maintained for                    et seq.
                                            a brief administrative review period in                     Under the Congressional Review Act,                ■  2. Section 199.21 is amended by:
                                            a ‘‘classification pending’’ status and be               a major rule may not take effect until at             ■  a. Adding paragraph (b)(3));
                                            available under terms comparable to                      least 60 days after submission to                     ■  b. Adding paragraph (g)(5);
                                            Third Tier drugs. The commenter                          Congress of a report regarding the rule.              ■  c. Revising paragraphs (h)(3)(i) and
                                            expressed the view that this is contrary                 A major rule is one that would have an                (ii);
                                            to the statute, which establishes the                    annual effect on the economy of $100                  ■ d. Republishing paragraph (h)(4);
                                            default position for brand name drugs at                 million or more or have certain other                 ■ e. Adding paragraph (h)(5);
                                            the Second Tier, and could impair                        impacts. For this purpose we note that                ■ f. Revising paragraphs (i)(2)(ii)
                                            prompt access to important new drugs.                    the budget savings identified in this                 through (v), and (i)(2)(x); and
                                               Response: DoD believes this change                    preamble are mostly associated with                   ■ g. Adding paragraphs (i)(2)(xii) and
                                            does not conflict with the statute, which                ‘‘housekeeping’’ changes to the Code of               (j)(4) and (5).
                                            does not address the issue of status                     Federal Regulations to conform to                        The additions and revisions read as
                                            pending the first opportunity of the                     specific statutory requirements, with                 follows:
                                            Pharmacy and Therapeutics Committee                      respect to which DoD has no
tkelley on DSK3SPTVN1PROD with RULES




                                            to consider the appropriate tier                         administrative discretion.                            § 199.21 TRICARE Pharmacy Benefits
                                            placement of the drug. TRICARE is                                                                              Program.
                                            trying to minimize the beneficiary                       Sec. 202, Public Law 104–4, ‘‘Unfunded                *      *    *     *     *
                                            confusion associated with tier changes.                  Mandates Reform Act’’                                    (b) * * *
                                            This administrative review period is                       This rule does not contain a Federal                   (3) Over-the-counter drug. A drug that
                                            very short. It will last not more than 120               mandate that may result in the                        is not subject to section 503(b)(1) of the


                                       VerDate Sep<11>2014   16:00 Jul 24, 2015   Jkt 235001   PO 00000   Frm 00022   Fmt 4700   Sfmt 4700   E:\FR\FM\27JYR1.SGM   27JYR1


                                                                Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Rules and Regulations                                         44273

                                            Federal Food, Drug, and Cosmetic Act                     state law to administer the vaccine. A                   (B) $8.00 co-payment per prescription
                                            (21 U.S.C. 353(b)(1)).                                   TRICARE authorized vaccine/                           for up to a 30-day supply of a generic
                                            *       *    *     *     *                               immunization includes only vaccines/                  pharmaceutical agent.
                                               (g) * * *                                             immunizations authorized as preventive                   (C) $0.00 co-payment for vaccines/
                                               (5) Administrative procedure for                      care under the basic program benefits of              immunizations authorized as preventive
                                            newly approved drugs. In the case of a                   § 199.4 of this part, as well as such care            care for eligible beneficiaries.
                                            newly approved innovator drug, other                     authorized for Prime enrollees under the                 (iii) For formulary and generic
                                            than a generic drug, the innovator drug                  uniform HMO benefit of § 199.18. For                  pharmaceutical agents obtained from a
                                            will, not later than 120 days after the                  Prime enrollees under the uniform HMO                 retail non-network pharmacy there is a
                                            date of approval by the Food and Drug                    benefit, a referral is not required under             20 percent or $20.00 co-payment
                                            Administration, be added to the uniform                  paragraph (n)(2) of § 199.18 for                      (whichever is greater) per prescription
                                            formulary unless prior to that date the                  preventive care vaccines/immunizations                for up to a 30-day supply of the
                                            P&T Committee has recommended that                       received from a retail network pharmacy               pharmaceutical agent.
                                            the agent be listed as a non-formulary                   that is a TRICARE authorized provider.                   (iv) For pharmaceutical agents
                                            drug. If the Director, DHA subsequently                  Any additional policies, instructions,                obtained under the TRICARE mail-order
                                            approves that recommendation, the drug                   procedures, and guidelines appropriate                program there is a:
                                                                                                     for implementation of this benefit may                   (A) $16.00 co-payment per
                                            will be so listed. If the Director, DHA
                                                                                                                                                           prescription for up to a 90-day supply
                                            disapproves the recommendation to list                   be issued by the TMA Director.
                                                                                                                                                           of a formulary pharmaceutical agent.
                                            the drug as non-formulary Third Tier,                       (5) Availability of selected over-the-                (B) $0.00 co-payment for up to a 90-
                                            the drug will be then classified per the                 counter (OTC) drugs under the                         day supply of a generic pharmaceutical
                                            Director’s decision. If, prior to the                    pharmacy benefits program. Although                   agent.
                                            expiration of 120 days, the P&T                          the pharmacy benefits program                            (C) $46.00 co-payment for up to a 90-
                                            Committee recommends that the agent                      generally covers only prescription                    day supply of a non-formulary
                                            be added to the uniform formulary and                    drugs, in some cases over-the-counter                 pharmaceutical agent. (D) $ 0.00 co-
                                            the recommendation is approved by the                    drugs may be covered and may be                       payment for smoking cessation
                                            Director, DHA, that will be done as soon                 placed on the uniform formulary.                      pharmaceutical agents covered under
                                            as feasible. Pending action under this                      (i) An OTC drug may be included on                 the smoking cessation program.
                                            paragraph (g)(5), the newly approved                     the uniform formulary upon the                        *       *     *    *    *
                                            pharmaceutical agent will be considered                  recommendation of the Pharmacy and                       (x) The per prescription co-payments
                                            to be in a classification pending status                 Therapeutics Committee and approval                   established in this paragraph (i)(2) may
                                            and will be available to beneficiaries                   of the Director, DHA, based on a finding              be adjusted periodically based on
                                            under Third Tier terms applicable to all                 that it is cost-effective and clinically              experience with the uniform formulary,
                                            other non-formulary agents.                              effective, as compared with other drugs               changes in economic circumstances,
                                            *       *    *     *     *                               in the same therapeutic class of                      and other appropriate factors. Any such
                                               (h) * * *                                             pharmaceutical agents. Clinical need is               adjustment must be approved by the
                                               (3) Availability of non-formulary                     judged by the criteria found in                       Assistant Secretary of Defense (Health
                                            pharmaceutical agents.—(i) General.                      paragraph (e)(1)(i) and (ii) of this                  Affairs). These additional requirements
                                            Non-formulary pharmaceutical agents                      section. Cost effectiveness is determined             apply:
                                            are generally not available in military                  based on criteria found in paragraph                     (A) Beginning January 1, 2016, the
                                            treatment facilities or in the retail point              (e)(2) of this section.                               amounts specified in this paragraph
                                            of service. They are available in the mail                  (ii) OTC drugs placed on the uniform               (i)(2) shall be increased annually by the
                                            order program.                                           formulary, in general, will be treated the            percentage increase in the cost-of-living
                                               (ii) Availability of non-formulary                                                                          adjustment by which retired pay is
                                                                                                     same as generic drugs on the uniform
                                            pharmaceutical agents at military                                                                              increased under 10 U.S. Code section
                                                                                                     formulary for purposes of availability in
                                            treatment facilities. Even when                                                                                1401a for the year, rounded down to the
                                                                                                     MTF pharmacies, retail pharmacies, and
                                            particular non-formulary agents are not                                                                        nearest dollar. However, with respect to
                                                                                                     the mail order pharmacy program and
                                            generally available at military treatment                                                                      any amount of increase that is less than
                                                                                                     other requirements. However, upon the
                                            facilities, they will be made available to                                                                     $1 or any amount lost in rounding down
                                                                                                     recommendation of the Pharmacy and
                                            eligible covered beneficiaries through                                                                         to the nearest dollar, that amount shall
                                                                                                     Therapeutics Committee and approval
                                            the non-formulary special approval                                                                             be carried over to, and accumulated
                                                                                                     of the Director, DHA, the requirement
                                            process as noted in this paragraph                                                                             with, the amount of the increase for the
                                                                                                     for a prescription may be waived for a
                                            (h)(3)(ii) when there is a valid medical                                                                       subsequent year or years and made
                                                                                                     particular OTC drug for certain
                                            necessity for use of the non-formulary                                                                         when the aggregate amount of increases
                                                                                                     emergency care treatment situations. In
                                            pharmaceutical agent.                                                                                          carried over for a year is $1 or more.
                                                                                                     addition, a special copayment may be
                                            *       *    *     *     *                               established under paragraph (i)(2)(xii) of               (B) Effective January 1, 2023 (unless
                                               (4) Availability of vaccines/                         this section for OTC drugs specifically               otherwise provided by law), the
                                            immunizations. A retail network                          used in certain emergency care                        Assistant Secretary of Defense for
                                            pharmacy may be an authorized                            treatment situations.                                 Health Affairs may adjust the amounts
                                            provider under the Pharmacy Benefits                                                                           specified in this paragraph (i)(2) as
                                                                                                        (i) * * *                                          considered appropriate. Between
                                            Program when functioning within the
                                            scope of its state laws to provide                          (2) * * *                                          January 1, 2016, and January 1, 2023,
                                            authorized vaccines/immunizations to                        (ii) For pharmaceutical agents                     the only adjustments allowed are the
tkelley on DSK3SPTVN1PROD with RULES




                                            an eligible beneficiary. The Pharmacy                    obtained from a retail network                        cost of living adjustments described in
                                            Benefits Program will cover the vaccine                  pharmacy there is a:                                  paragraph (i)(2)(x)(A) of this section,
                                            and its administration by the retail                        (A) $20.00 co-payment per                          unless otherwise provided by law.
                                            network pharmacy, including                              prescription required for up to a 30-day              *       *     *    *    *
                                            administration by pharmacists who                        supply of a formulary pharmaceutical                     (xii) Special copayment rule for OTC
                                            meet the applicable requirements of                      agent.                                                drugs in the retail pharmacy network.


                                       VerDate Sep<11>2014   16:00 Jul 24, 2015   Jkt 235001   PO 00000   Frm 00023   Fmt 4700   Sfmt 4700   E:\FR\FM\27JYR1.SGM   27JYR1


                                            44274               Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Rules and Regulations

                                            As a general rule, OTC drugs placed on                   www.regulations.gov, type the docket                      organizational and conforming
                                            the uniform formulary under paragraph                    number in the ‘‘SEARCH’’ box, and                         amendments. For that reason, the Coast
                                            (h)(5) of this section will have                         click ‘‘Search.’’ If you do not have                      Guard finds it has good cause to issue
                                            copayments equal to those for generic                    access to the Internet, you may view the                  this rule without first giving the public
                                            drugs on the uniform formulary.                          docket online by visiting the Docket                      an opportunity to comment,2 and to
                                            However, upon the recommendation of                      Management Facility in room W12–140                       make the rule effective less than 30 days
                                            the Pharmacy and Therapeutics                            of the ground floor of the Department of                  after publication in the Federal
                                            Committee and approval of the Director,                  Transportation West Building, 1200                        Register.3
                                            DHA, the copayment may be established                    New Jersey Avenue SE., Washington,
                                                                                                                                                               III. Basis and Purpose
                                            at $0.00 for any particular OTC drug in                  DC 20590, between 9 a.m. and 5 p.m.,
                                            the retail pharmacy network.                             Monday through Friday, except Federal                        The legal basis of this rule is found in
                                               (j) * * *                                             holidays.                                                 5 U.S.C. 552(a) and 553; 14 U.S.C. 2(3)
                                               (4) Upon the recommendation of the                    FOR FURTHER INFORMATION CONTACT: If                       and 631–633; 33 U.S.C. 471 and 499;
                                            Pharmacy and Therapeutics Committee,                     you have questions on this final rule,                    and Department of Homeland Security
                                            a generic drug may be classified as non-                 call or email Mr. Paul Crissy, Coast                      Delegation No. 0170.1.
                                            formulary if it is less cost effective than              Guard; telephone 202–372–1093, email                         The purpose of this rule is to provide
                                            non-generic formulary drugs in the same                  Paul.H.Crissy@uscg.mil. If you have                       the public with more accurate and
                                            drug class.                                              questions on viewing the docket, call                     current regulatory information by
                                               (5) The beneficiary copayment                         Ms. Cheryl Collins, Program Manager,                      making technical, organizational, and
                                            amount for any generic drug                              Docket Operations, telephone 202–366–                     conforming amendments to existing
                                            prescription may not exceed the total                    9826.                                                     regulations throughout Title 33 of the
                                            charge for that prescription.                                                                                      Code of Federal Regulations (33 CFR).
                                                                                                     SUPPLEMENTARY INFORMATION:
                                            *       *    *     *     *                                                                                         This rule does not change the impact on
                                                                                                     Table of Contents for Preamble                            the public of any Coast Guard
                                              Dated: July 21, 2015.                                                                                            regulation.
                                                                                                     I. Abbreviations
                                            Patricia L. Toppings,
                                                                                                     II. Regulatory History                                    IV. Discussion of the Rule
                                            OSD Federal Register Liaison Officer,                    III. Basis and Purpose
                                            Department of Defense.                                   IV. Discussion of the Rule                                   Each year, the Coast Guard issues
                                            [FR Doc. 2015–18290 Filed 7–24–15; 8:45 am]              V. Regulatory Analyses                                    technical, organizational, and
                                            BILLING CODE 5001–06–P                                      A. Regulatory Planning and Review                      conforming amendments to existing
                                                                                                        B. Small Entities                                      regulations in 33 CFR. These annual
                                                                                                        C. Assistance for Small Entities                       ‘‘technical amendments’’ provide the
                                                                                                        D. Collection of Information                           public with more accurate and current
                                            DEPARTMENT OF HOMELAND                                      E. Federalism
                                            SECURITY                                                                                                           regulatory information, but do not
                                                                                                        F. Unfunded Mandates Reform Act
                                                                                                        G. Taking of Private Property
                                                                                                                                                               change the impact on the public of any
                                            Coast Guard                                                 H. Civil Justice Reform                                Coast Guard regulation.
                                                                                                        I. Protection of Children                                 The rule makes changes in the
                                            33 CFR Parts 3, 50, 51, 52, 62, 67, 72,                     J. Indian Tribal Governments                           following sections of 33 CFR:
                                            80, 82, 83, 84, 90, 96, 100, 101, 110, 117,                 K. Energy Effects                                         Sections 3.35–1, 3.35–35, 3.40–1(b),
                                            150, 151, 155, 156, 161, 162, 164, 165,                     L. Technical Standards                                 3.40–10: Shift several Seventh and
                                            177, and 183                                                M. Environment                                         Eighth Coast Guard District boundaries
                                                                                                     I. Abbreviations                                          so that they coincide with existing
                                            [Docket No. USCG–2015–0433]
                                                                                                                                                               county political boundaries.
                                            RIN–1625–AC25                                            CFR—Code of Federal Regulations                              Part 50 authority line: Change from
                                                                                                     DHS—Department of Homeland Security                       ‘‘Sec. 8, 18 Stat. 127, as amended, sec.
                                            Navigation and Navigable Waters;                         E.O.—Executive Order                                      302, 58 Stat. 287, as amended; 14 U.S.C.
                                            Technical, Organizational, and                           FR—Federal Register
                                                                                                                                                               92, 38 U.S.C. 693i’’ to ‘‘Sec. 10 U.S.C.
                                            Conforming Amendments                                    NOAA—National Oceanic and Atmospheric
                                                                                                       Administration                                          1554; 14 U.S.C. 92, 633; Department of
                                                                                                     OMB—Office of Management and Budget                       Homeland Security Delegations No.
                                            AGENCY:    Coast Guard, DHS.
                                                                                                     Pub. L.—Public Law                                        0160.1(II)(B)(1), 0170.1(II)(23)’’ to
                                            ACTION:   Final rule.                                    §—Section symbol                                          conform to obsolete statutory references
                                            SUMMARY:  This final rule makes non-                     U.S.C.—United States Code                                 to current equivalents. Specifically, 18
                                            substantive technical, organizational,                                                                             Stat. 127 was superseded by 14 U.S.C.
                                                                                                     II. Regulatory History
                                            and conforming amendments to existing                                                                              92 and 633 in 1949. Section 302 of 58
                                                                                                        This rule is subject to several                        Stat. 287 was codified at 38 U.S.C. 693i;
                                            regulations throughout Title 33 of the                   exceptions from the regulatory
                                            Code of Federal Regulations. These                                                                                 that section was later re-enacted as 10
                                                                                                     procedure requirements of 5 U.S.C. 553.                   U.S.C. 1553 and 1554 in Public Law 85–
                                            changes provide the public with more                     Before issuing this rule, the Coast Guard
                                            accurate and current regulatory                                                                                    857 in 1958.
                                                                                                     did not provide a notice of proposed                         Sections 50.1, 50.3, 50.5, 50.6: Change
                                            information, but they do not change the                  rulemaking, because it is not required to
                                            impact on the public of any Coast Guard                                                                            ‘‘officer’’ to ‘‘member or former
                                                                                                     do so because this rule involves rules of                 member’’ to reflect change to 10 U.S.C.
                                            regulation.                                              agency organization, procedure, or                        1554 authorization for Retiring Review
                                            DATES: This final rule is effective July                 practice.1 Moreover, notice and                           Board.
tkelley on DSK3SPTVN1PROD with RULES




                                            27, 2015.                                                comment is unnecessary because the                           Part 51 authority line: Change from
                                            ADDRESSES: Documents mentioned in                        rule does not change the impact on the                    ‘‘10 U.S.C. 1553; Pub. L. 107–296, 116
                                            this preamble as being available in the                  public of any Coast Guard regulation,                     Stat. 2135’’ to ‘‘10 U.S.C. 1553; 14
                                            docket are part of docket USCG–2015–                     but only makes non-substantive
                                            0433. To view documents mentioned in                                                                                 25    U.S.C. 553(b)(B).
                                            this preamble, go to                                          15   U.S.C. 553(b)(A).                                 35    U.S.C. 553(d)(3).



                                       VerDate Sep<11>2014   16:00 Jul 24, 2015   Jkt 235001   PO 00000    Frm 00024      Fmt 4700   Sfmt 4700   E:\FR\FM\27JYR1.SGM    27JYR1



Document Created: 2018-02-23 09:26:56
Document Modified: 2018-02-23 09:26:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis final rule is effective August 26, 2015.
ContactDr. George E. Jones, Jr., Chief, Pharmacy Operations Division, Defense Health Agency, telephone 703-681- 2890.
FR Citation80 FR 44269 
RIN Number0720-AB57
CFR AssociatedClaims; Health Care; Health Insurance; Military Personnel and Pharmacy Benefits

2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR