(a) General--
(1) Statutory
authority.
Title 10, U.S. Code, Section
1074g requires that the Department of Defense establish an effective,
efficient, integrated pharmacy benefits program for the Military
Health System. This law is independent of a number of sections of
Title 10 and other laws that affect the benefits, rules, and procedures
of TRICARE, resulting in changes to the rules otherwise applicable
to TRICARE Prime, Standard, and Extra.
(2) Pharmacy
benefits program.
(i) Applicability.
The pharmacy
benefits program, which includes the uniform formulary and its associated
tiered co-payment structure, is applicable to all of the uniformed
services. Geographically, except as specifically provided in paragraph
(a)(2)(ii) of this section, this program is applicable to all 50
states and the District of Columbia, Guam, Puerto Rico, and the
Virgin Islands. In addition, if authorized by the Assistant Secretary
of Defense (Health Affairs) (ASD(HA)), the TRICARE pharmacy benefits
program may be implemented in areas outside the 50 states and the
District of Columbia, Guam, Puerto Rico, and the Virgin Islands. In
such case, the ASD(HA) may also authorize modifications to the pharmacy
benefits program rules and procedures as may be appropriate to the
area involved.
(ii) Applicability
exception.
The pharmaceutical benefit
under the TRICARE smoking cessation program under Sec. 199.4(e)(30)
is available to TRICARE beneficiaries who are not entitled to Medicare
benefits authorized under Title XVIII of the Social Security Act.
Except as noted in Sec. 199.4(e)(30), the smoking cessation program,
including the pharmaceutical benefit, is not applicable or available
to beneficiaries who reside overseas, including the U. S. territories
of Guam, Puerto Rico, and the Virgin Islands, except that under
the authority of Sec. 199.17 active duty service members and active
duty dependents enrolled in TRICARE Prime residing overseas, including
the U. S. territories of Guam, Puerto Rico, and the Virgin Islands,
shall have access to smoking cessation pharmaceuticals through either
an MTF or the TMOP program where available.
(3) Uniform
formulary.
The pharmacy benefits program
features a uniform formulary of pharmaceutical agents as defined
in Sec. 199.2.
(i) The
uniform formulary will assure the availability of pharmaceutical
agents in the complete range of therapeutic classes authorized as
basic program benefits.
(ii) As
required by 10 U.S.C. 1074g(a)(2) and implemented under the procedures
established by paragraphs (e) and (f) of this section, pharmaceutical
agents in each therapeutic class are selected for inclusion on the
uniform formulary based upon the relative clinical effectiveness
and cost effectiveness of the agents in such class. If a pharmaceutical
agent in a therapeutic class is determined by the Department of
Defense Pharmacy and Therapeutics Committee not to have a significant,
clinically meaningful therapeutic advantage in terms of safety, effectiveness,
or clinical outcome over other pharmaceutical agents included on
the uniform formulary, the Committee may recommend it be classified
as a non-formulary agent. In addition, if the evaluation by the Pharmacy
and Therapeutics Committee concludes that a pharmaceutical agent
in a therapeutic class is not cost effective relative to other pharmaceutical
agents in that therapeutic class, considering costs, safety, effectiveness, and
clinical outcomes, the Committee may recommend it be classified
as a non-formulary agent.
(iii) Pharmaceutical
agents which are used exclusively in medical treatments or procedures
that are expressly excluded from the TRICARE benefit by statute
or regulation will not be considered for inclusion on the uniform formulary.
Excluded pharmaceutical agents shall not be available as non-formulary
agents, nor will they be cost-shared under the TRICARE pharmacy
benefits program.
(b) Definitions.
For most definitions applicable
to the provisions of this section, refer to Sec. 199.2. The following
definitions apply only to this section:
(1) Clinically
necessary.
Also referred to as clinical
necessity. Sufficient evidence submitted by a beneficiary or provider
on behalf of the beneficiary that establishes that one or more of
the following conditions exist: The use of formulary pharmaceutical
agents is contraindicated; the patient experiences significant adverse
effects from formulary pharmaceutical agents in the therapeutic
class, or is likely to experience significant adverse effects from formulary
pharmaceutical agents in the therapeutic class; formulary pharmaceutical
agents result in therapeutic failure, or the formulary pharmaceutical
agent is likely to result in therapeutic failure; the patient previously responded
to a non-formulary pharmaceutical agent and changing to a formulary
pharmaceutical agent would incur an unacceptable clinical risk;
or there is no alternative pharmaceutical agent on the formulary.
(2) Therapeutic
class.
A group of pharmaceutical agents
that are similar in chemical structure, pharmacological effect,
and/or clinical use.
(3) Over-the-counter
drug.
A drug that is not subject
to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)(1)).
(c) Department
of Defense Pharmacy and Therapeutics Committee--
(1) Purpose.
The Department of Defense Pharmacy
and Therapeutics Committee is established by 10 U.S.C. 1074g to
assure that the selection of pharmaceutical agents for the uniform
formulary is based on broadly representative professional expertise concerning
relative clinical and cost effectiveness of pharmaceutical agents
and accomplishes an effective, efficient, integrated pharmacy benefits
program.
(2) Composition.
As required by 10 U.S.C. 1074g(b),
the committee includes representatives of pharmacies of the uniformed
services facilities and representatives of providers in facilities
of the uniformed services. Committee members will have expertise
in treating the medical needs of the populations served through
such entities and in the range of pharmaceutical and biological
medicines available for treating such populations.
(3) Executive
Council.
The Pharmacy and Therapeutics
Committee may have an Executive Council, composed of those voting
and non-voting members of the Committee who are military or civilian
employees of the Department of Defense. The function of the Executive
Council is to review and analyze issues relating to the operation
of the uniform formulary, including issues of an inherently governmental
nature, procurement sensitive information, and matters affecting
military readiness. The Executive Council presents information to
the Pharmacy and Therapeutics Committee, but is not authorized to
act for the Committee.
(d) Uniform
Formulary Beneficiary Advisory Panel.
As required
by 10 U.S.C. 1074g(c), a Uniform Formulary Beneficiary Advisory
Panel reviews and comments on the development of the uniform formulary.
The Panel includes members that represent non-governmental organizations
and associations that represent the views and interests of a large
number of eligible covered beneficiaries, contractors responsible
for the TRICARE retail pharmacy program, contractors responsible
for the TRICARE mail-order pharmacy program, and TRICARE network providers.
The panel will meet after each Pharmacy and Therapeutics Committee
quarterly meeting. The Panel’s comments will be submitted to the
Director, TRICARE Management Activity. The Director will consider
the comments before implementing the uniform formulary or any recommendations
for change made by the Pharmacy and Therapeutics Committee. The
Panel will function in accordance with the Federated Advisory Committee
Act (5 U.S.C. App. 2).
(e) Determinations
regarding relative clinical and cost effectiveness for the selection
of pharmaceutical agents for the uniform formulary--
(1) Clinical
effectiveness.
(i) It is presumed
that pharmaceutical agents in a therapeutic class are clinically
effective and should be included on the uniform formulary unless
the Pharmacy and Therapeutics Committee finds by a majority vote
that a pharmaceutical agent does not have a significant, clinically meaningful
therapeutic advantage in terms of safety, effectiveness, or clinical
outcome over the other pharmaceutical agents included on the uniform
formulary in that therapeutic class. This determination is based
on the collective professional judgment of the DoD Pharmacy and
Therapeutics Committee and consideration of pertinent information
from a variety of sources determined by the Committee to be relevant
and reliable. The DoD Pharmacy and Therapeutics Committee has discretion
based on its collective professional judgment in determining what
sources should be reviewed or relied upon in evaluating the clinical
effectiveness of a pharmaceutical agent in a therapeutic class.
(ii) Sources of information
may include but are not limited to:
(A) Medical
and pharmaceutical textbooks and reference books;
(B) Clinical literature;
(C) U.S. Food and Drug
Administration determinations and information;
(D) Information from
pharmaceutical companies;
(E) Clinical
practice guidelines, and
(F) Expert
opinion.
(iii) The
DoD Pharmacy and Therapeutics Committee will evaluate the relative
clinical effectiveness of pharmaceutical agents within a therapeutic
class by considering information about their safety, effectiveness,
and clinical outcome.
(iv) Information
considered by the Committee may include but is not limited to:
(A) U.S. Food and Drug
Administration approved and other studied indications;
(B) Pharmacology;
(C) Pharmacokinetics;
(D) Contraindications;
(E) Warnings/precautions;
(F) Incidence and severity
of adverse effects;
(G) Drug
to drug, drug to food, and drug to disease interactions;
(H) Availability, dosing,
and method of administration;
(I) Epidemiology and
relevant risk factors for diseases/conditions in which the pharmaceutical
agents are used;
(J) Concomitant
therapies;
(K) Results
of safety and efficacy studies;
(L) Results of effectiveness/clinical
outcomes studies, and
(M) Results
of meta-analyses.
(2) Cost effectiveness.
(i) In considering
the relative cost effectiveness of pharmaceutical agents in a therapeutic class,
the DoD Pharmacy and Therapeutics Committee shall evaluate the costs
of the agents in relation to the safety, effectiveness, and clinical
outcomes of the other agents in the class.
(ii) Information considered
by the Committee concerning the relative cost effectiveness of pharmaceutical agents
may include but is not limited to:
(A) Cost
of the pharmaceutical agent to the Government;
(B) Impact on overall
medical resource utilization and costs;
(C) Cost-efficacy studies;
(D) Cost-effectiveness
studies;
(E) Cross-sectional
or retrospective economic evaluations;
(F) Pharmacoeconomic
models;
(G) Patent
expiration dates;
(H) Clinical
practice guideline recommendations, and
(I) Existence of existing
or proposed blanket purchase agreements, incentive price agreements,
or contracts.
(3) Special rules for best
clinical effectiveness. (i) Under the authority
of 10 U.S.C. 1074g(a)(10), the Pharmacy and Therapeutics Committee
may recommend and the Director may, after considering the comments
and recommendations of the Beneficiary Advisory Panel, approve special
uniform formulary actions to encourage use of pharmaceutical agents
that provide the best clinical effectiveness to covered beneficiaries
and DoD, including consideration of better care, healthier people,
and smarter spending. Such special actions may operate as exceptions
to the normal rules and procedures under 10 U.S.C. 1074g(a)(2),
(5) and (6) and the related provisions of this section.
(ii) Actions
under paragraph (e)(3)(i) of this section may include a complete
or partial exclusion from the pharmacy benefits program of any pharmaceutical
agent the Director determines provides very little or no clinical effectiveness
relative to similar agents to covered beneficiaries and DoD. A partial
exclusion under this paragraph may take the form (as one example)
of a limitation on the clinical conditions, diagnoses, or indications
for which the pharmaceutical agent may be prescribed. A partial
exclusion may be implemented through any means recommended by the
Pharmacy and Therapeutics Committee, including but not limited to
preauthorization under paragraph (k) of this section. In the case
of a partial exclusion, a pharmaceutical agent may be available
on the non-formulary tier of the uniform formulary for limited purposes
and for other purposes be excluded.
(iii) Actions under paragraph
(e)(3)(i) of this section may also include giving preferential status
to any non-generic pharmaceutical agent of the uniform formulary
by treating it for purposes of cost-sharing as a generic product.
(f) Evaluation
of pharmaceutical agents for determinations regarding inclusion
on the uniform formulary.
The DoD Pharmacy and Therapeutics
Committee will periodically evaluate or re-evaluate individual pharmaceutical
agents and therapeutic classes of pharmaceutical agents for determinations
regarding inclusion or continuation on the uniform formulary. Such
evaluation or re-evaluation may be prompted by a variety of circumstances
including, but not limited to:
(1) Approval of a new
pharmaceutical agent by the U.S. Food and Drug Administration;
(2) Approval
of a new indication for an existing pharmaceutical agent;
(3) Changes in the
clinical use of existing pharmaceutical agents;
(4) New information
concerning the safety, effectiveness or clinical outcomes of existing
pharmaceutical agents;
(5) Price
changes;
(6) Shifts
in market share;
(7) Scheduled
review of a therapeutic class; and
(8) Requests from Pharmacy
and Therapeutics Committee members, military treatment facilities,
or other Military Health System officials.
(g) Administrative
procedures for establishing and maintaining the uniform formulary--
(1) Pharmacy
and Therapeutics Committee determinations.
Determinations
of the Pharmacy and Therapeutics Committee are by majority vote
and recorded in minutes of Committee meetings. The minutes set forth
the determinations of the committee regarding the pharmaceutical
agents selected for inclusion in the uniform formulary and summarize the
reasons for those determinations. For any pharmaceutical agent (including
maintenance medications) for which a recommendation is made that
the status of the agent be changed from the formulary tier to the
non-formulary tier of the uniform formulary, or that the agent requires
a pre-authorization, the Committee shall also make a recommendation
as to effective date of such change that will not be longer than
180 days from the final decision date but may be less. The minutes
will include a record of the number of members voting for and against the
Committee’s action.
(2) Beneficiary
Advisory Panel.
Comments and recommendations
of the Beneficiary Advisory Panel are recorded in minutes of Panel
meetings. The minutes set forth the comments and recommendations
of the Panel and summarize the reasons for those comments and recommendations.
The minutes will include a record of the number of members voting
for or against the Panel’s comments and recommendations.
(3) Uniform
formulary final decisions.
The Director of the TRICARE
Management Activity makes the final DoD decisions regarding the
uniform formulary. Those decisions are based on the Director’s review
of the final determinations of the Pharmacy and Therapeutics Committee
and the comments and recommendations of the Beneficiary Advisory
Panel. No pharmaceutical agent may be designated as non-formulary
on the uniform formulary unless it is preceded by such recommendation
by the Pharmacy and Therapeutics Committee. The decisions of the
Director of the TRICARE Management Activity are in writing and establish
the effective date(s) of the uniform formulary actions.
(4) Transition
to the Uniform Formulary.
Beginning in Fiscal Year 2005,
under an updated charter for the DoD P&T Committee, the committee
shall meet at least quarterly to review therapeutic classes of pharmaceutical
agents and make recommendations concerning which pharmaceutical
agents should be on the Uniform Formulary, the Basic Care Formulary
(BCF), and Extended Core Formulary (ECF). The P&T Committee
will review the classes in a methodical, but expeditious manner.
During the transition period from the previous methodology of formulary management
involving only the MTFs and the TMOP Program, previous decisions
by the predecessor DoD P&T Committee concerning MTF and Mail
Order Pharmacy Program formularies shall continue in effect. As
therapeutic classes are reviewed under the new formulary management
process, the processes established by this section shall apply.
(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) Obtaining
pharmacy services under the retail network pharmacy benefits program.
(1) Points
of service.
There are four outpatient pharmacy
points of service:
(i) Military
Treatment Facilities (MTFs);
(ii) Retail network
pharmacies: Those are non-MTF pharmacies that are a part of the
network established for TRICARE retail pharmacy services;
(iii) Retail non-network
pharmacies: Those are non-MTF pharmacies that are not part of the
network established for TRICARE retail pharmacy services, and
(iv) the TRICARE Mail
Order Pharmacy (TMOP).
(2) Availability
of formulary pharmaceutical agents.
(i) General.
Subject to paragraphs (h)(2)(ii)
and (h)(2)(iii) of this section, formulary pharmaceutical agents
are available under the Pharmacy Benefits Program from all points
of service identified in paragraph (h)(1) of this section.
(ii) Availability
of formulary pharmaceutical agents at military treatment facilities
(MTF).
Pharmaceutical agents included
on the uniform formulary are available through facilities of uniformed
services, consistent with the scope of health care services offered
in such facilities and additional determinations by the P&T
Committee of the relative clinical effectiveness and cost effectiveness,
based on costs to the Program associated with providing the agents
to beneficiaries. The BCF is a subset of the uniform formulary and
is a mandatory component of formularies at all full-service MTF
pharmacies. The BCF contains the minimum set of pharmaceutical agents
that each full-service MTF pharmacy must have on its formulary to
support the primary care scope of practice for Primary Care Manager enrollment
sites. Limited-service MTF pharmacies (e.g., specialty pharmacies
within an MTF or pharmacies servicing only active duty military
members) are not required to include the entire BCF on their formularies,
but may limit their formularies to those BCF agents appropriate
to the needs of the patients they serve. An ECF may list preferred agents
in drug classes other than those covered by the BCF. Among BCF and
ECF agents, individual MTF formularies are determined by local P&T
Committees based on the scope of health care services provided at
the respective MTFs. All pharmaceutical agents on the local formulary
of full-service MTF pharmacies must be available to all categories
of beneficiaries.
(iii) Pharmaceutical
agents prescribed for smoking cessation are not available for coverage
when obtained through a retail pharmacy. This includes network and
non-network retail pharmacies.
(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.
(iii) Availability
of clinically appropriate non-formulary pharmaceutical agents to
members of the Uniformed Services.
The pharmacy
benefits program is required to assure the availability of clinically
appropriate pharmaceutical agents to members of the uniformed services,
including, where appropriate, agents not included on the uniform formulary.
Clinically appropriate pharmaceutical agents will be made available
to members of the Uniformed Services, including, where medical necessity
has been validated, agents not included on the uniform formulary. MTFs
shall establish procedures to evaluate the clinical necessity of
prescriptions written for members of the uniformed services for
pharmaceutical agents not included on the uniform formulary. If
it is determined that the prescription is clinically necessary,
the MTF will provide the pharmaceutical agent to the member.
(iv) Availability
of clinically appropriate pharmaceutical agents to other eligible
beneficiaries at retail pharmacies or the TMOP.
Eligible
beneficiaries will receive non-formulary pharmaceutical agents at
the formulary cost-share when medical necessity has been established
by the beneficiary and/or his/her provider. The peer review provisions
of Sec. 199.15 shall apply to the clinical necessity pre-authorization
determinations. TRICARE may require that the time for review be
expedited under the pharmacy benefits program.
(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)
Cost-sharing
requirements under the pharmacy benefits program--
(1) General.
Under 10 U.S.C. 1074g(a)(6),
cost-sharing requirements are established in this section for the
pharmacy benefits program independent of those established under
other provisions of this Part. Cost-shares under this section partially
defray government costs of administering the pharmacy benefits program
when collected by the government for prescriptions dispensed through
the retail network pharmacies or the TRICARE Mail Order Pharmacy.
The higher cost-share paid for prescriptions dispensed by a non-network
retail pharmacy is established to encourage the use of the most
economical venue to the government. Cost-sharing requirements are
based on the classification of a pharmaceutical agent as generic,
formulary, or non-formulary, in conjunction with the point of service
from which the agent is acquired.
(2) Cost-sharing
amounts.
Active duty members of the
uniformed services do not pay cost-shares or annual deductibles.
For other categories of beneficiaries, after applicable annual deductibles
are met, cost-sharing amounts prior to October 1, 2016, are set
forth in this paragraph (i)(2):
(i) For pharmaceutical
agents obtained from a military treatment facility, there is no
cost-sharing or annual deductible.
(ii) For
pharmaceutical agents obtained from a retail network pharmacy, the
cost share will be as provided in 10 U.S.C. 1074g(a)(6), except
that there is a $0 cost-share for vaccines/immunizations authorized
as preventive care for eligible beneficiaries.
(iii) For formulary
and generic pharmaceutical agents obtained from a retail non-network
pharmacy, except as provided in paragraph (i)(2)(vi) of this section,
there is a 20 percent or $20.00 cost-share (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,
the cost share will be as provided in 10 U.S.C. 1074g(a)(6), except
that there is a $0 cost-share for smoking cessation pharmaceutical
agents covered under the smoking cessation program.
(v) [Reserved]
(vi) For TRICARE Prime
beneficiaries there is no annual deductible applicable for pharmaceutical
agents obtained from retail network pharmacies or the TRICARE mail-order
program. However, for TRICARE Prime beneficiaries who obtain formulary
or generic pharmaceutical agents from retail nonnetwork pharmacies,
an enrollment year deductible of $300 per person and $600 per family
must be met after which there is a beneficiary cost-share of 50 percent
per prescription for up to a 30-day supply of the pharmaceutical
agent.
(vii) For TRICARE Select
beneficiaries the annual deductible which must be met before the
cost-sharing amounts for pharmaceutical agents in paragraph (i)(2)
of this section are applicable is as provided for each category
of TRICARE Select enrollee in Sec. 199.17(l)(2).
(viii) For TRICARE
beneficiaries not otherwise qualified to enroll in TRICARE Prime
or Select, the annual deductible which must be met before the cost-sharing
amounts for pharmaceutical agents in paragraph (i)(2) of this section are
applicable is as provided in Sec. 199.4(f).
(ix) The TRICARE catastrophic
cap limits apply to pharmacy benefits program cost-sharing.
(x)
For
any year after 2027, the cost-sharing amounts under this paragraph
shall be equal to the cost-sharing amounts for the previous year
adjusted by an amount, if any, determined by the Director to reflect
changes in the costs of pharmaceutical agents and prescription dispensing,
rounded to the nearest dollar. These cost changes, if any, will
consider costs under the TRICARE pharmacy benefits program calculated
separately for each of the following categories based on prescriptions
filled in the most recent period for which TRICARE cost data are available,
updated to the current year, if necessary, by appropriate industry
data:(A) Generic
drugs in the retail point of service;
(B) Formulary drugs in the
retail point of service;
(C) Generic drugs in the
mail order point of service;
(D) Formulary drugs in the
mail order point of service;
(E) Non-formulary drugs.
(xi) For a Medicare-eligible
beneficiary, the cost-sharing requirements may not be in excess
of the cost-sharing requirements applicable to all other beneficiaries
covered by 10 U.S.C. 1086.
(xii) Special
copayment rule for OTC drugs in the retail pharmacy network.
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.
(3) Special
cost-sharing rule when there is a clinical necessity for use of
a non-formulary pharmaceutical agent.
(i) When there is a
clinical necessity for the use of a non-formulary pharmaceutical
agent that is not otherwise excluded as a covered benefit, the pharmaceutical
agent will be provided at the same co-payment as a formulary pharmaceutical
agent can be obtained.
(ii) A
clinical necessity for use of a non-formulary pharmaceutical agent
is established when the beneficiary or their provider submits sufficient
information to show that one or more of the following conditions
exist:
(A) The use of formulary
pharmaceutical agents is contraindicated;
(B) The patient experiences
significant adverse effects from formulary pharmaceutical agents,
or the provider shows that the patient is likely to experience significant
adverse effects from formulary pharmaceutical agents;
(C) Formulary pharmaceutical
agents result in therapeutic failure, or the provider shows that
the formulary pharmaceutical agent is likely to result in therapeutic
failure;
(D) The
patient previously responded to a non-formulary pharmaceutical agent
and changing to a formulary pharmaceutical agent would incur unacceptable
clinical risk; or
(E) There
is no alternative pharmaceutical agent on the formulary.
(iii) Information to
establish clinical necessity for use of a non-formulary pharmaceutical
agent should be provided to TRICARE for prescriptions submitted
to a retail network pharmacy.
(iv) Information to
establish clinical necessity for use of a non-formulary pharmaceutical
agent should be provided as part of the claims processes for non-formulary
pharmaceutical agents obtained through non-network points of service,
claims as a result of other health insurance, or any other situations
requiring the submission of a manual claim.
(v) Information to
establish clinical necessity for use of a non-formulary pharmaceutical
agent may be provided with the prescription submitted to the TMOP
contractor.
(vi) Information
to establish clinical necessity for use of a non-formulary pharmaceutical
agent may also be provided at a later date, but no later than sixty
days from the dispensing date, as an appeal to reduce the non-formulary
co-payment to the same co-payment as a formulary drug.
(vii) The process of
establishing clinical necessity will not unnecessarily delay the
dispensing of a prescription. In situations where clinical necessity
cannot be determined in a timely manner, the non-formulary pharmaceutical agent
will be dispensed at the non-formulary co-payment and a refund provided
to the beneficiary should clinical necessity be established.
(viii) Peer review
and appeal and hearing procedures. All levels of peer review, appeals,
and grievances established by the Contractor for internal review
shall be exhausted prior to forwarding to TRICARE Management Activity
for a formal review. Procedures comparable to those established
under Secs. 199.15 and 199.10 of this part shall apply. If it is
determined that the prescription is clinically necessary, the pharmaceutical
agent will be provided to the beneficiary at the formulary cost-share.
TRICARE may require that the time periods for peer review or for
appeal and hearing be expedited under the pharmacy benefits program.
For purposes of meeting the amount in dispute requirement of Sec.
199.10(a)(7), the relevant amount is the difference between the
cost shares of a formulary versus non-formulary drug. The amount
for each of multiple prescriptions involving the same drug to treat
the same medical condition and filled within a 12-month period may
be combined to meet the required amount in dispute.
(j) Use
of generic drugs under the pharmacy benefits program.
(1) The designation
of a drug as a generic, for the purpose of applying cost-shares
at the generic rate, will be determined through the use of standard pharmaceutical
references as part of commercial best business practices. Pharmaceutical
agents will be designated as generics when listed with an “A” rating
in the current Approved Drug Products with Therapeutic Equivalence Evaluations
(Orange Book) published by the Food and Drug Administration, or
any successor to such reference. Generics are multisource products
that must contain the same active ingredients, are of the same dosage
form, route of administration and are identical in strength or concentration.
(2) The
pharmacy benefits program generally requires mandatory substitution
of generic drugs listed with an “A” rating in the current Approved
Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
published by the FDA and generic equivalents of grandfather or Drug
Efficacy Study Implementation (DESI) category drugs for brand name
drugs. In cases in which there is a clinical justification for a
brand name drug in lieu of a generic equivalent, under the standards
and procedures of paragraph (h)(3) of this section, the generic
substitution policy is waived.
(3) When a blanket
purchase agreement, incentive price agreement, Government contract,
or other circumstances results in a brand pharmaceutical agent being
the most cost effective agent for purchase by the Government, the
Pharmacy and Therapeutics Committee may also designate that the
drug be cost-shared at the generic rate.
(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.
(k) Preauthorization
of certain pharmaceutical agents.
(1) Selected
pharmaceutical agents may be subject to prior authorization or utilization
review requirements to assure medical necessity, clinical appropriateness
and/or cost effectiveness.
(2) The Pharmacy and
Therapeutics Committee will assess the need to prior authorize a
given agent by considering the relative clinical and cost effectiveness
of pharmaceutical agents within a therapeutic class. Pharmaceutical
agents that require prior authorization will be identified by a
majority vote of the Pharmacy and Therapeutics Committee. The Pharmacy
and Therapeutics Committee will establish the prior authorization
criteria for the pharmaceutical agent.
(3) Prescriptions for
pharmaceutical agents for which prior authorization criteria are
not met will not be cost-shared under the TRICARE pharmacy benefits
program.
(4) The
Director, TRICARE Management Activity, may issue policies, procedures,
instructions, guidelines, standards or criteria to implement this
paragraph (k).
(l) TRICARE
Senior Pharmacy Program.
Section 711 of the Floyd D.
Spence National Defense Authorization Act for Fiscal Year 2001 (Public
Law 106-398, 114 Stat. 1654A-175) established the TRICARE Senior
Pharmacy Program for Medicare eligible beneficiaries effective April
1, 2001. These beneficiaries are required to meet the eligibility
criteria as prescribed in Sec. 199.3 of this part. The benefit under
the TRICARE Senior Pharmacy Program applies to prescription drugs
and medicines provided on or after April 1, 2001.
(m) Effect
of other health insurance.
The double coverage rules of
section 199.8 of this part are applicable to services provided under
the pharmacy benefits program. For this purpose, the Medicare prescription
drug benefit under Medicare Part D, prescription drug benefits provided
under Medicare Part D plans are double coverage plans and such plans
will be the primary payer, to the extent described in section 199.8
of this part. Beneficiaries who elect to use these pharmacy benefits
shall provide DoD with other health insurance information.
(n) Procedures.
The Director, TRICARE Management
Activity shall establish procedures for the effective operation
of the pharmacy benefits program. Such procedures may include restrictions
of the quantity of pharmaceuticals to be included under the benefit,
encouragement of the use of generic drugs, implementation of quality
assurance and utilization management activities, and other appropriate
matters.
(o) Preemption
of State laws.
(1) Pursuant to 10
U.S.C. 1103, the Department of Defense has determined that in the
administration of 10 U.S.C. chapter 55, preemption of State and
local laws relating to health insurance, prepaid health plans, or
other health care delivery or financing methods is necessary to
achieve important Federal interests, including but not limited to
the assurance of uniform national health programs for military families
and the operation of such programs at the lowest possible cost to
the Department of Defense, that have a direct and substantial effect
on the conduct of military affairs and national security policy
of the United States.
(2) Based
on the determination set forth in paragraph (o)(1) of this section,
any State or local law relating to health insurance, prepaid health
plans, or other health care delivery or financing methods is preempted
and does not apply in connection with TRICARE pharmacy contracts.
Any such law, or regulation pursuant to such law, is without any
force or effect, and State or local governments have no legal authority
to enforce them in relation to the TRICARE pharmacy contracts. However,
the Department of Defense may by contract establish legal obligations on
the part of TRICARE contractors to conform with requirements similar
or identical to requirements of State or local laws or regulations.
(3) The preemption
of State and local laws set forth in paragraph (o)(1) of this section
includes State and local laws imposing premium taxes on health or
dental insurance carriers or underwriters or other plan managers,
or similar taxes on such entities. Such laws are laws relating to
health insurance, prepaid health plans, or other health care delivery
or financing methods, within the meaning of the statutes identified
in paragraph (o)(1) of this section. Preemption, however, does not
apply to taxes, fees, or other payments on net income or profit
realized by such entities in the conduct of business relating to
DoD pharmacy services contracts, if those taxes, fees or other payments
are applicable to a broad range of business activity. For purposes
of assessing the effect of Federal preemption of State and local
taxes and fees in connection with DoD pharmacy services contracts,
interpretations shall be consistent with those applicable to the
Federal Employees Health Benefits Program under 5 U.S.C. 8909(f).
(p) General
fraud, abuse, and conflict of interest requirements under TRICARE
pharmacy benefits program.
All fraud, abuse, and conflict
of interest requirements for the basic CHAMPUS program, as set forth
in this part 199 (see applicable provisions of Sec. 199.9 of this
part) are applicable to the TRICARE pharmacy benefits program. Some
methods and procedures for implementing and enforcing these requirements
may differ from the methods and procedures followed under the basic
CHAMPUS program.
(q) Pricing
standards for retail pharmacy program--
(1) Statutory
requirement.
(i) As required by
10 U.S.C. 1074g(f), with respect to any prescription filled on or
after the date of the enactment of the National Defense Authorization
Act for Fiscal Year 2008, the TRICARE retail pharmacy program shall
be treated as an element of the DoD for purposes of the procurement
of drugs by Federal agencies under 38 U.S.C. 8126 to the extent
necessary to ensure pharmaceuticals paid for by the DoD that are
provided by pharmacies under the program to eligible covered beneficiaries
under this section are subject to the pricing standards in such
section 8126.
(ii) Under
paragraph (q)(1)(i) of this section, all covered drug TRICARE retail
pharmacy network prescriptions are subject to Federal Ceiling Prices
under 38 U.S.C. 8126.
(2) Manufacturer
written agreement.
(i) A
written agreement by a manufacturer to honor the pricing standards required
by 10 U.S.C. 1074g(f) and referred to in paragraph (q)(1) of this
section for pharmaceuticals provided through retail network pharmacies
shall with respect to a particular covered drug be a condition for:
(A) Inclusion of that
drug on the uniform formulary under this section; and
(B) Availability of
that drug through retail network pharmacies without preauthorization
under paragraph (k) of this section.
(ii) A covered drug
not under an agreement under paragraph (q)(2)(i) of this section
requires preauthorization under paragraph (k) of this section to
be provided through a retail network pharmacy under the Pharmacy
Benefits Program. This preauthorization requirement does not apply
to other points of service under the Pharmacy Benefits Program.
(iii) For purposes
of this paragraph (q)(2), a covered drug is a drug that is a covered
drug under 38 U.S.C. 8126, but does not include:
(A) A drug that is
not a covered drug under 38 U.S.C. 8126;
(B) A drug provided
under a prescription that is not covered by 10 U.S.C. 1074g(f);
(C) A drug that is
not provided through a retail network pharmacy under this section;
(D) A drug provided
under a prescription which the TRICARE Pharmacy Benefits Program
is the second payer under paragraph (m) of this section;
(E) A drug provided
under a prescription and dispensed by a pharmacy under section 340B
of the Public Health Service Act; or
(F) Any other exception
for a drug, consistent with law, established by the Director, TMA.
(iv) The requirement
of this paragraph (q)(2) may, upon the recommendation of the Pharmacy
and Therapeutics Committee, be waived by the Director, TMA if necessary
to ensure that at least one drug in the drug class is included on
the Uniform Formulary. Any such waiver, however, does not waive
the statutory requirement referred to in paragraph (q)(1) that all
covered TRICARE retail network pharmacy prescriptions are subject
to Federal Ceiling Prices under 38 U.S.C. 8126; it only waives the
exclusion from the Uniform Formulary of drugs not covered by agreements
under this paragraph (q)(2).
(3) Refund
procedures.
(i) Refund procedures
to ensure that pharmaceuticals paid for by the DoD that are provided
by retail network pharmacies under the pharmacy benefits program
are subject to the pricing standards referred to in paragraph (q)(1)
of this section shall be established. Such procedures may be established
as part of the agreement referred to in paragraph (q)(2), or in
a separate agreement, or pursuant to Sec. 199.11.
(ii) The refund procedures
referred to in paragraph (q)(3)(i) of this section shall, to the
extent practicable, incorporate common industry practices for implementing
pricing agreements between manufacturers and large pharmacy benefit
plan sponsors. Such procedures shall provide the manufacturer at
least 70 days from the date of the submission of the TRICARE pharmaceutical
utilization data needed to calculate the refund before the refund payment
is due. The basis of the refund will be the difference between the
average non-federal price of the drug sold by the manufacturer to
wholesalers, as represented by the most recent annual non-Federal
average manufacturing prices (non-FAMP) (reported to the Department
of Veterans Affairs (VA)) and the corresponding FCP or, in the discretion
of the manufacturer, the difference between the FCP and direct commercial
contract sales prices specifically attributable to the reported
TRICARE paid pharmaceuticals, determined for each applicable NDC listing.
The current annual FCP and the annual non-FAMP from which it was
derived will be applicable to all prescriptions filled during the
calendar year.
(iii) A
refund due under this paragraph (q) is subject to Sec. 199.11 of
this part and will be treated as an erroneous payment under that
section.
(A) A manufacturer
may under section 199.11 of this part request waiver or compromise
of a refund amount due under 10 U.S.C. 1074g(f) and this paragraph
(q).
(B) During the pendency
of any request for waiver or compromise under paragraph (q)(3)(iii)(A)
of this section, a manufacturer’s written agreement under paragraph
(q)(2) shall be deemed to exclude the matter that is the subject of
the request for waiver or compromise. In such cases the agreement,
if otherwise sufficient for the purpose of the condition referred
to in paragraph (q)(2), will continue to be sufficient for that
purpose. Further, during the pendency of any such request, the matter
that is the subject of the request shall not be considered a failure
of a manufacturer to honor a requirement or an agreement for purposes
of paragraph (q)(4).
(C) In
addition to the criteria established in Sec. 199.11, a request for
waiver may also be premised on the voluntary removal by the manufacturer
in writing of a drug from coverage in the TRICARE Pharmacy Benefit Program.
(iv) In the case of
disputes by the manufacturer of the accuracy of TMA’s utilization
data, a refund obligation as to the amount in dispute will be deferred
pending good faith efforts to resolve the dispute in accordance
with procedures established by the Director, TMA. If the dispute
is not resolved within 60 days, the Director, TMA will issue an
initial administrative decision and provide the manufacturer with
opportunity to request reconsideration or appeal consistent with
procedures under section 199.10 of this part. When the dispute is
ultimately resolved, any refund owed relating to the amount in dispute
will be subject to an interest charge from the date payment of the amount
was initially due, consistent with section 199.11 of this part.
(4) Remedies.
In the case of the failure
of a manufacturer of a covered drug to honor a requirement of this paragraph
(q) or to honor an agreement under this paragraph (q), the Director,
TMA, in addition to other actions referred to in this paragraph
(q), may take any other action authorized by law.
(5) Beneficiary
transition provisions.
In cases in which a pharmaceutical
is removed from the uniform formulary or designated for preauthorization
under paragraph (q)(2) of this section, the Director, TMA may for
transitional time periods determined appropriate by the Director
or for particular circumstances authorize the continued availability
of the pharmaceutical in the retail pharmacy network or in MTF pharmacies
for some or all beneficiaries as if the pharmaceutical were still
on the uniform formulary.
(r) Refills
of maintenance medications for eligible covered beneficiaries through
the mail order pharmacy program--
(1) In
general.
Consistent with section 702
of the National Defense Authorization Act for Fiscal Year 2015,
this paragraph requires that for non-generic covered maintenance
medications, beneficiaries are generally required to obtain their
prescription through the national mail-order pharmacy program or
through military treatment facility pharmacies. For purposes of
this paragraph, eligible covered beneficiaries are those defined under
sections 1072 and 1086 of title 10, United States Code.
(2) Medications
covered.
The Director, DHA, will establish,
maintain, and periodically revise and update a list of non-generic
covered maintenance medications subject to the requirement of paragraph
(r)(1) of this section. The current list will be accessible through
the TRICARE Pharmacy Program Internet Web site and by telephone
through the TRICARE Pharmacy Program Service Center. Each medication
included on the list will meet the following requirements:
(i) It will be a medication
prescribed for a chronic, long-term condition that is taken on a
regular, recurring basis.
(ii) It
will be clinically appropriate to dispense the medication from the
mail order pharmacy.
(iii) It
will be cost effective to dispense the medication from the mail
order pharmacy.
(iv) It
will be available for an initial filling of a 30-day or less supply
through retail pharmacies.
(v) It
will be generally available at military treatment facility pharmacies
for initial fill and refills.
(vi) It will be available
for refill through the national mail-order pharmacy program.
(3) Refills
covered.
For purposes of the program
under paragraph (r)(1) of this section, a refill is:
(i) A subsequent filling
of an original prescription under the same prescription number or
other authorization as the original prescription; or
(ii) A new original
prescription issued at or near the end date of an earlier prescription
for the same medication for the same patient.
(4) Waiver
of requirement.
A waiver of the general requirement
to obtain maintenance medication prescription refills from the mail
order pharmacy or military treatment facility pharmacy will be granted
in the following circumstances:
(i) There is a blanket
waiver for prescription medications that are for acute care needs.
(ii) There is a blanket
waiver for prescriptions covered by other health insurance.
(iii) There is a case-by-case
waiver to permit prescription maintenance medication refills at
a retail pharmacy when necessary due to personal need or hardship,
emergency, or other special circumstance. This waiver is obtained
through an administrative override request to the TRICARE pharmacy
benefits manager under procedures established by the Director, DHA.
(5) Procedures.
Under the program established
by paragraph (r)(1) of this section, the Director, DHA will establish
procedures for the effective operation of the program. Among these
procedures are the following:
(i) The Department
will implement the program by utilizing best commercial practices
to the extent practicable.
(ii) An
effective communication plan that includes efforts to educate beneficiaries
in order to optimize participation and satisfaction will be implemented.
(iii) Beneficiaries
with active retail prescriptions for a medication on the maintenance
medication list will be notified that their medication is included
under the program. Beneficiaries will be advised that they may receive two
30 day fill at retail while they transition their prescription to
the mail order program.
(iv) Requests
for a third fill at retail will result in 100% patient cost shares
and will be blocked from any TRICARE payments and the beneficiary
advised to call the pharmacy benefits manager (PBM) for assistance.
(v) The PBM will provide
a toll free number to assist beneficiaries in transferring their
prescriptions from retail to the mail order program. With the beneficiary’s
permission, the PBM will contact the physician or other health care provider
who prescribed the medication to assist in transferring the prescription
to the mail order program.
(vi) In
any case in which a beneficiary required under paragraph (r) of
this section to obtain a maintenance medication prescription refill
from national mail order pharmacy program and attempts instead to
refill such medications at a retail pharmacy, the PBM will also
maintain the toll free number to assist the beneficiary. This assistance
may include information on how to request a waiver, consistent with
paragraph (r)(4)(iii) of this section, or in taking any other appropriate
action to meet the beneficiary’s needs and to implement the program.
(vii) The PBM will
ensure that a pharmacist is available at all times through the toll-free
telephone number to answer beneficiary questions or provide other
appropriate assistance.
(6) This program will
remain in effect indefinitely with any adjustments or modifications
required by law.
[69 FR 17048, Apr 1, 2004;
74 FR 11292, Mar 17, 2009; 74 FR 55776, Oct 29, 2009; 74 FR 65438,
Dec 10, 2009; 75 FR 63397, Oct 15, 2010; 76 FR 41065, Jul 13, 2011;
78 FR 13241, Feb 27, 2013; 78 FR 75247, Dec 11, 2013; 80 FR 44272, Jul
27, 2015; 80 FR 46798, Aug 6, 2015; 81 FR 76310, Nov 2, 2016; 82
FR 45457, Sep 29, 2017; 83 FR 63577, Dec 11, 2018]