TITLE:  Merck & Company, Inc., B-295888, May 13, 2005
BNUMBER:  B-295888
DATE:  May 13, 2005
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   Decision

   Matter of: Merck & Company, Inc.

   File: B-295888

   Date: May 13, 2005

   Deneen J. Melander, Esq., and Steven A. Alerding, Esq., Fried, Frank,
Harris, Shriver & Jacobson LLP, for the protester.

   Lynn T. Burleson, Esq., TRICARE Management Activity, Department of
Defense, for the agency.

   Ralph O. White, Esq., and Christine S. Melody, Esq., Office of the General
Counsel, GAO, participated in the preparation of the decision.

   DIGEST

   1.  Government Accountability Office has jurisdiction to review a protest
challenging the terms of a quotation request for a possible blanket
purchase agreement which is being used by the Department of Defense's
TRICARE Management Activity (pursuant to its statutory authority to
establish a pharmacy benefits program, including a uniform formulary) to
inform, and then implement, a TRICARE formulary determination. 

   2.  Decision by the TRICARE Management Activity to consider the cost of
pharmaceutical agents obtained by TRICARE beneficiaries at retail
pharmacies participating in TRICARE's retail pharmacy network as part of
its review of cost effectiveness undertaken to determine whether to add a
pharmaceutical agent to the uniform formulary is reasonable where the
statutory authorization for the pharmacy benefit program requires the
agency to consider the cost effectiveness of pharmaceutical agents as part
of any such determination, and where the record shows that more than half
of TRICARE's expenditures for pharmaceutical agents are incurred for
prescriptions filled by beneficiaries at such retail pharmacies.

   3.  Protester's assertion that the agency is unreasonably obtaining
quotations applicable to only two of the venues where TRICARE
beneficiaries can have their prescriptions filled (military treatment
facilities and the mail order pharmacy), and is using what is, in essence,
a plug number unique to each company (i.e., the Federal Ceiling Price
applicable to certain types of purchases from the Federal Supply Schedule)
for its assessment of the costs that will be incurred in purchasing each
agent from participating retail pharmacies (the third venue where
prescriptions can be filled) is denied where the agency reasonably decided
that it should consider the costs of pharmaceutical agents obtained by
beneficiaries at such pharmacies; where the Secretary of the Department of
Veterans Affairs has determined that the Federal Ceiling Price applies to
TRICARE retail pharmacy purchases; and where the Federal Ceiling Price
will be the actual price paid by TRICARE if the Secretarial determination,
which is being challenged by certain pharmaceutical manufacturers, remains
in place.

   4.  Protester's argument that a request for blanket purchase agreement
price quotations improperly fails to identify the relative importance of
clinical and cost effectiveness that will be used by the TRICARE Pharmacy
& Therapeutics Committee to select pharmaceutical agents for inclusion on
the uniform and basic core formularies is denied where the request is
consistent with the statutory scheme, which does not identify the relative
importance of these two considerations, and which reserves for the
discretion of health care professionals the decision about which agents
will be included on the formulary, and where, even though this request is
limited to vendors submitting quotations for pharmaceutical agents
included on their Federal Supply Schedule contracts, there is no
requirement in the request that vendors select a particular configuration
of their offered products.   

   DECISION

   Merck & Company, Inc. protests the actions of the Department of Defense's
(DOD) TRICARE Management Activity in announcing its first review of
pharmaceutical agents[1] for inclusion in the newly-implemented,
statutorily-based TRICARE uniform formulary.[2]  To announce its
review--which will include the angiotensin II receptor blocker (ARB) drug
class, within which Merck manufactures an agent known as Losartan--TRICARE
posted on its website an open letter to pharmaceutical manufacturers
(dated December 22, 2004) explaining how it would assess the cost
effectiveness of individual pharmaceutical agents in making formulary
determinations.

   In its December 22 letter, the agency simultaneously advised manufacturers
of "an opportunity to provide cost information in the form of a Uniform
Formulary Blanket Purchase Agreement price quotation," and advised how the
DOD Pharmacy & Therapeutics (P&T) Committee would determine costs for any
manufacturer that elected not to provide a price quotation.  Agency Report
(AR), Tab C.3, at 1.  Merck raises five distinct challenges to the request
for price quotations, and to the process TRICARE has chosen to gather
prices for, and implement, its formulary decisions.

   We deny the protest.

   BACKGROUND

   Section 701 of the Fiscal Year 2000 National Defense Authorization Act
required that DOD "establish an effective, efficient, integrated pharmacy
benefits program" within its managed healthcare program, which DOD refers
to as TRICARE.  Pub. L. No. 105-65, Div. A, Title VII, S 701(a)(1), Oct.
5, 1999, 113 Stat. 677 (now codified at 10 U.S.C. S 1074g(a)(1)).  One
part of the program authorized by this recently-enacted statute is the
TRICARE uniform formulary.  As discussed in greater detail below,
TRICARE's uniform formulary is based on concepts and presumptions quite
different from those reviewed in our previous decisions regarding
so-called "formulary procurements"[3]--such as those conducted by the
Department of Veterans Affairs (VA), or even other DOD entities.  See,
e.g., Bristol-Myers Squibb Co., B-294944.2, Jan. 18, 2005, 2005 CPD P 16
(VA formulary); SmithKline Beecham Corp., B-283939, Jan. 27, 2000, 2000
CPD P 19 (VA formulary); Bristol-Myers Squibb Co., B-281681.12,
B-281681.13, Dec. 16, 1999, 2000 CPD P 23 (DOD formulary).

   As an overview, we note that TRICARE's authorizing statute and regulations
presume the clinical efficacy of pharmaceutical agents for inclusion on
the uniform formulary unless and until the agency reaches a different
decision.  In addition, a TRICARE formulary decision generally does not
limit a beneficiary's access to a pharmaceutical agent.  Instead, a
decision to include a given agent on the formulary establishes a lower
level of co-payment for beneficiaries; these co-payments also fluctuate
depending upon the venue in which the prescription is filled--i.e., at a
military treatment facility, via the mail order pharmacy, or at a retail
pharmacy.  Further, under TRICARE's formulary scheme, a committee of
health care professionals makes the decision about both the clinical and
cost effectiveness of pharmaceutical agents under consideration, and the
committee may elect to make that decision without using any dedicated
procurement vehicle whatsoever--meaning that the committee can simply
import pricing information from existing Federal Supply Schedule
contracts, and other relevant pricing information, to inform its formulary
decisions. 

   Statutory and Regulatory Framework for TRICARE's Uniform Formulary

   The TRICARE program provides services to approximately 9.1 million
beneficiaries, including active duty service members, their families,
military retirees, and their eligible family members and survivors. 
Contracting Officer's (CO) Statement, Mar. 7, 2005, at 2.  A central
element of the newly-authorized TRICARE pharmacy benefit is establishment
of a uniform formulary of pharmaceutical agents.  10 U.S.C. S
1074g(a)(2).  Under this program, TRICARE expects to dispense almost $5
billion in pharmaceutical agents annually.  AR, Tab C.40, at 6. 
Expenditures for the ARB drug class at issue here have become one of the
10 largest drug class expenditures in the military healthcare system.  P&T
Committee Minutes, Feb. 16, 2005, at 18.

   TRICARE's uniform formulary process anticipates that individual
pharmaceutical agents will be selected for inclusion on the formulary
based on their relative clinical and cost effectiveness within their drug
class.  10 U.S.C. S 1074g(a)(2)(A).  Nonetheless, under the TRICARE
system, all appropriate pharmaceutical agents must be presumed clinically
effective unless DOD's P&T Committee finds that an agent "does not have a
significant, clinically meaningful therapeutic advantage in terms of
safety, effectiveness, or clinical outcome over other drugs included on
the uniform formulary."  10 U.S.C. S 1074g(a)(2)(B). 

   The P&T Committee also evaluates the costs of agents within a given drug
class in relation to their safety, effectiveness, and clinical outcomes. 
10 U.S.C. S 1074g(a)(2)(C).  Both the evaluation of cost and clinical
effectiveness are to be made pursuant to procedures developed by the
Secretary, which are now set forth at 32 C.F.R. S 199.21 (2004).  10
U.S.C. S 1074g(a)(2)(D).

   In considering the clinical effectiveness of a pharmaceutical agent,
TRICARE's regulations advise that the P&T Committee has discretion based
on its collective professional judgment about what sources should be
reviewed, or relied upon, to make its determinations.  32 C.F.R. S
199.21(e)(1).  The regulations identify in detail the types of sources and
types of information that may be included in such a review, but do not
limit the review to the sources and information identified.  Id.

   In considering the cost effectiveness of a pharmaceutical agent, TRICARE's
regulations advise that the P&T Committee's review may include, but is not
limited to, nine types of information.  32 C.F.R. S 199.21(e)(2)(ii). 
These are:  (1) cost of the agent to the government; (2) impact on
resource utilization and costs; (3) cost-efficacy studies; (4)
cost-effectiveness studies; (5) cross-sectional or retrospective economic
evaluations; (6) pharmacoeconomic models; (7) patent expiration dates; (8)
clinical practice guideline recommendations; and (9) "existence of
existing or proposed blanket purchase agreements, incentive price
agreements, or contracts."  Id.

   In addition to the above-described decisions about whether to include a
pharmaceutical agent on the formulary, there is another component of the
TRICARE pharmacy benefit program that must be reflected here--i.e., the
three venues where a TRICARE beneficiary can have prescriptions filled.  A
beneficiary's choice of prescribing venue has an effect on the cost of the
prescription to the beneficiary.  (There are also requirements for
stocking one of these venues with pharmaceutical agents that are relevant
here.)  Finally, a beneficiary's choice of a prescribing venue also has an
effect on the cost of the prescription to TRICARE, which we will address
below.        

   The first, and least expensive, of the three venues available to TRICARE
beneficiaries seeking to obtain prescription drugs is the military
treatment facility (MTF).  An MTF is a direct care facility where a
beneficiary receives his or her prescription without any cost share.  CO's
Statement at 2.  DOD explains that there are more than 536 dispensing
facilities in 121 MTFs.  AR, Tab C.40, at 6.  Although MTFs dispense drugs
directly to beneficiaries, the stock of drugs available at an MTF is
likely more limited than the stock at other venues; this is because MTFs
are only required to stock drugs consistent with the scope of health care
services offered by an MTF.  10 U.S.C. S 1074g(a)(2)(E)(i).  In
recognition of this characteristic of an MTF, TRICARE has developed the
concept of the basic core formulary, which is a subset of the uniform
formulary, and constitutes the mandatory minimum set of pharmaceutical
agents that must be stocked at each MTF pharmacy.[4]  32 C.F.R. S
199.21(h)(2)(ii).

   The second of the three venues available for filling prescriptions is
TRICARE's national mail-order pharmacy (TMOP), which, DOD explains, is one
of the largest mail-order prescription operations in the nation.  AR, Tab
C.40, at 6.  Using this option, beneficiaries can receive up to a 90-day
supply of a pharmaceutical agent with a $3 co-payment per prescription for
generic agents, a $9 co-payment per prescription for brand-name formulary
agents, or a $22 co-payment for brand-name non-formulary agents.  32
C.F.R. S 199.21(i)(2)(v).

   The third of the three venues available are retail pharmacies, and in
particular, retail pharmacies that participate in the TRICARE retail
pharmacy network (the "retail network pharmacies").  The agency advises
that there are now over 54,000 retail network pharmacies.  AR, Tab C.40,
at 6.  At retail network pharmacies, pharmaceutical agents are available
to beneficiaries at the same co-payment as at the TMOP, although each
prescription is limited to no more than a 30-day supply.[5]  32 C.F.R. S
199.21(i)(2)(ii).  (In the event a beneficiary has a medical need for a
non-formulary agent, both the TMOP and retail network pharmacies must
provide the agent at the $9 co-payment applicable to formulary agents.  32
C.F.R. S 199.21(i)(3)(i).)

   As indicated above, a beneficiary's selection of one of the three
prescribing venues also has cost implications for TRICARE.  Specifically,
MTFs and the TMOP are able to purchase pharmaceutical agents using the
"Big Four" Federal Supply Schedule (FSS), operated by the General Services
Administration (GSA).[6]  AR, Tab C.3, at 1.  As a result, TRICARE pays a
standard government price, established in advance, for pharmaceutical
agents purchased by MTFs and the TMOP. 

   Retail network pharmacies, however, because of their nature as
private-sector entities, are not able to purchase pharmaceutical agents
from the FSS, and thus are not able to obtain government discounts.  Id. 
The practical implication of this situation for TRICARE is that it will
not know how many drugs have been purchased from retail network pharmacies
(or the price at which those drugs were purchased by the beneficiary),
until it receives a request for payment from the retail network pharmacy
for the difference between the purchase price and the applicable
co-payment.  These underlying and basic differences in the relationships
between TRICARE and the prescribing venues are significantly related to
Merck's protest issues. 

   TRICARE's Actions Related to its Request for Price Quotations for Agents
in the ARB Drug Class

   By letter dated December 22, 2004, and posted to the TRICARE website, the
agency advised pharmaceutical manufacturers of the process by which the
cost of pharmaceutical agents would be determined for purposes of deciding
whether to include those agents on TRICARE's uniform formulary.  AR, Tab
C.3, at 1.  The letter directed manufacturers to the website of the DOD's
Pharmacoeconomic Center (http://www.pec.ha.osd.mil/PT_Committee.htm) for
specific information about the drug classes to be reviewed in a February
2005 meeting of the P&T Committee. 

   The December 22 letter advised that the cost of a pharmaceutical agent for
the formulary review would be determined "based on consideration of the
cost of the agent under each of the three DOD venues for dispensing agents
to TRICARE beneficiaries, i.e., [MTFs]; the [TMOP]; and the TRICARE Retail
Pharmacy Program."  Id.  The letter also directed manufacturers to
additional information, posted elsewhere on the website, titled "Uniform
Formulary Blanket Purchase Agreement Information" (hereinafter, "Uniform
Formulary BPA Information").  AR, Tab C.8.  This posting sets forth
general instructions for pharmaceutical manufacturers considering
submitting price quotations for use in formulary determinations.  In
addition, the Uniform Formulary BPA Information reiterates that formulary
reviews will consider the cost of a pharmaceutical agent under all three
dispensing venues, and advises that the cost of those agents dispensed by
non-network pharmacies will not be considered in making formulary
determinations.  AR, Tab C.8, at 1.

   With respect to the cost of pharmaceutical agents dispensed by retail
network pharmacies, both the December 22 letter (AR, Tab C.3, at 1) and
the Uniform Formulary BPA Information (AR, Tab C.8, at 2) advise that
TRICARE will look to the "Federal Ceiling Price" applicable to drugs
purchased by DOD under depot contracting systems, again pursuant to 38
U.S.C. S 8126.[7]  Both also explain that the Federal Ceiling Price was
recently extended to the TRICARE retail pharmacy program by determination
of the Secretary of the VA, which was distributed to pharmaceutical
manufacturers via letter dated October 14, 2004.  In its protest, Merck
explains that the VA decision to consider the TRICARE retail pharmacy
program a virtual depot contracting system is disputed by pharmaceutical
manufacturers.[8] 

   With respect to the cost of agents dispensed by the MTFs and the TMOP,
both the December 22 letter and the Uniform Formulary BPA Information
advise that manufacturers can elect to offer a reduction from their FSS
prices, which will then be reflected in a BPA.  Absent such a quotation,
the letter advises that TRICARE will use the "Big Four" FSS price to
determine the cost of dispensing an individual agent at the MTFs and the
TMOP.  AR, Tab C.3, at 1.  The Uniform Formulary BPA Information further
explains that the cost of brand name pharmaceutical agents for formulary
determinations will be based on the lowest of the following:  (1) the
Federal Ceiling Price; (2) the "Big Four" FSS price; (3) the BPA price
quotation, if any; and (4) the price specified in any existing price
agreement applicable to the MTF and TMOP dispensing venues.  AR, Tab C.8,
at 1-2.  In addition, it advises that price quotations for upcoming drug
class reviews must be submitted via an attached template, and that the
"P&T Committee will not accept multiple, conditional or marketshare based
[quotations] at this time."  Id. at 2.

   The template for price quotations (also available at the website) collects
limited information from manufacturers, who must represent that they hold
existing FSS contracts for their drug, and agree that they will hold the
quotation open for 180 days.  AR, Tab C.9, at 2-3.  The template permits
manufacturers to submit separate quotations by dosage form and strength,
with separate prices depending on whether the agent is dispensed by an MTF
or the TMOP if the agent is included on the uniform formulary, and a
separate MTF price if the agent is also selected for inclusion on the
basic core formulary (the mandatory minimum list of pharmaceutical agents
that all MTFs must stock).  Id. at 3.

   In addition to the general documents described above, TRICARE also posted
specific information related to the P&T Committee's intended review of the
ARB drug class.  AR, Tab C.7.  This document identified each of the seven
agents within the class (including Merck's Losartan) and their respective
dosing strengths, and advised that price quotations could be submitted
until February 7, 2005.  Id. at 1.  Further, this document advised that
the agents selected for the uniform formulary would form the pool of
agents to be considered for the basic core formulary, for which, at least
one, but not more than three, agents would be selected.  Id. at 2. 

   Shortly before the February 7 due date for submission of price quotations,
Merck filed a protest with our Office challenging what it terms
"improprieties and other defects in a Request for Blanket Purchase
Agreement Price Quotes (RFQ) issued by [DOD/TRICARE]."  Initial Protest,
Feb. 4, 2005, at 1.  Despite the filing of Merck's protest, the P&T
Committee went forward with its planned review of the pharmaceutical
agents within the ARB drug class for inclusion on the uniform formulary. 

   In the minutes of the P&T Committee review, which were subsequently posted
on the website of the DOD's Pharmacoeconomic Center, the Committee
explained that it would identify its conclusions, present them to the
Director of the TRICARE Management Activity for approval, but not proceed
with the award of a BPA until our Office ruled on the protest.  P&T
Committee Minutes, supra, at 21.  During its review, the Committee
selected six of the seven pharmaceutical agents in the ARB drug class,
including Merck's Losartan, for inclusion on the uniform formulary; the
Committee selected one of those six agents, not Merck's Losartan, for the
basic core formulary.  Id. at 20, 22.

   DISCUSSION

   Merck raises five distinct challenges to the above-described TRICARE
actions, all of which are based on a theory of standard procurement
policies and instruments.  In our view, Merck's challenges ignore unique
and basic underlying differences between the actions at issue here, and
those at issue in the procurements Merck cites.  Rather than paraphrase
Merck's arguments--which, necessarily, begins the process of answering
them--we set forth below each of Merck's contentions in its own words:   

   1.  The RFQ improperly provides that the cost of pharmaceutical agents in
the TRICARE Retail Pharmacy Network will be included in the DOD's
evaluation of the cost effectiveness of agents for inclusion on the
Uniform Formulary;

   2.  The RFQ improperly provides that the cost of pharmaceutical agents in
the TRICARE Retail Pharmacy Network will be considered to be the Federal
Ceiling Price for purposes of the DOD's evaluation of the cost
effectiveness of agents for inclusion on the Uniform Formulary;

   3.  The DOD's methodology under the RFQ for calculating the weighted
average cost per day of therapy is flawed because it is based upon
historical usage data that is unreliable due to the limited usage of newer
pharmaceutical agents;

   4.  The RFQ fails to adequately explain the relative importance of
clinical effectiveness and cost effectiveness, and the relative importance
of the various clinical factors, in the evaluation; and

   5.  The DOD's refusal to accept alternative price quotes under the RFQ is
unreasonable and inconsistent with the [Federal Acquisition Regulation's]
"best value" mandate.

   Initial Protest, Feb. 4, 2005, at 2.

   Jurisdiction

   Shortly after Merck's protest was filed, TRICARE requested partial
dismissal of three of the bases of this protest, specifically the
arguments numbered 1, 2, and 3 above, on the ground that our Office lacks
jurisdiction to review its actions related to the selection of
pharmaceutical agents for TRICARE's uniform formulary.  TRICARE contends
that the statute which governs its uniform formulary is not a procurement
statute, and points out that even if it canceled its request for BPA price
quotations, it could continue with its planned decision about which agents
to include on the formulary. 

   As an initial matter, our review of government actions is limited to
procurements of goods or services by a federal agency.  31 U.S.C. S
3551(1) (2000).  In our view, the agency's actions here clearly constitute
a procurement.  Specifically, TRICARE has requested quotations leading to
the establishment of one or more BPAs for purchasing selected
pharmaceutical agents.[9]   The selection of these agents will be done by
TRICARE under its pharmacy benefits statute.  That selection decision, in
turn, will trigger significant procurements of the pharmaceutical agents
selected.[10]

   As relevant to this case, our Office is authorized to decide bid protests
"concerning an alleged violation of a procurement statute or regulation." 
31 U.S.C. S 3552(a) (2000), amended by the Ronald W. Reagan National
Defense Authorization Act for Fiscal Year 2005, Pub. L. No. 108-375, S
326, 118 Stat. 1811 (2004).  Although protests usually involve alleged
violations of statutes that are indisputably procurement statutes, such as
CICA, we will hear protests alleging violations of other statutes or
regulations when those statutes or regulations bear directly on federal
agency procurements.  Sam Gonzales, Inc.--Recon., B-225542.2, Mar. 18,
1987, 87-1 CPD P 306 at 2 (provision of the Bankruptcy Act prohibiting
discrimination against debtors did not bear directly on a federal agency
procurement for purposes of determining jurisdiction, although GAO issued
a decision on the merits at the request of the agency and the Bankruptcy
Court); Solano Garbage Co., B-225397, B-225398, Feb. 5, 1987, 87-1 CPD P
125 at 3, recon. denied, B-225397.2, B-2253978.2, June 5, 1987, 87-1 CPD P
571 (jurisdiction exists over protest alleging violation of 42 U.S.C. S
6961, part of the Resource Conservation and Recovery Act of 1976, because
interpreting the statute at issue "does not change the fundamental nature
of the dispute as one requiring us to decide, under CICA, whether a
'solicitation, proposed award, or award complies with statute and
regulation'").  See also Peter N.G. Schwartz Cos. Judiciary Square Ltd.
Partnership, B-239007.3, Oct. 31, 1990, 90-2 CPD P 353 at 4 (jurisdiction
exists over protest alleging violation of 40 U.S.C. S 490(h), a provision
related to GSA's lease authority, because the statute will "directly bear
upon federal agency procurements").

   With respect to the statutory grant of authority to TRICARE to establish a
uniform formulary, we agree with the agency that the central purpose of
this statute is to task TRICARE with providing pharmacy benefits to its
beneficiaries, and with establishing a process for making pharmaceutical
agents available to beneficiaries at each of the possible prescription
dispensing venues.  See generally 10 U.S.C. S 1074g.  For purposes of
determining whether our Office has authority to review this protest,
however, we believe that the TRICARE pharmacy benefits statute is
appropriately viewed as a procurement statute as well.  It is abundantly
clear that formulary decisions made by TRICARE (at least for MTFs and the
TMOP) will lead to the purchase of pharmaceutical agents using the
FSS--that is, to procurements of goods by a federal agency.  This is
precisely the kind of statute which bears directly on a federal agency
procurement, even though the statute exists primarily for other purposes. 
As a result, we have jurisdiction to consider whether the agency is
reasonably complying with the TRICARE pharmacy benefits statute, and is
conducting the procurement fairly. 

   The Substance of Merck's Challenges

   We turn first to Merck's initial contention that the RFQ[11] here
improperly provides that the cost of pharmaceutical agents in retail
network pharmacies will be included in the evaluation of cost
effectiveness that will be made to determine whether to include an agent
on the uniform formulary.      

   In reviewing the reasonableness of TRICARE's solicitation for the purchase
of pharmaceutical agents for its formulary, we note first the statutory
directive that TRICARE's selection of agents for inclusion on its uniform
formulary must consider the relative clinical and cost effectiveness of
those agents.  10 U.S.C. S 1074g(a)(2)(B).  In addition, the regulations
that implement this statute provide that one of the elements that may be
considered as part of a determination of cost effectiveness is the cost of
the pharmaceutical agent to the government.  32 C.F.R. S
199.21(e)(2)(ii). 

   While Merck correctly points out that there is no requirement within the
statute to consider the cost of pharmaceutical agents dispensed at each of
the venues available to beneficiaries for filling prescriptions, we note,
as does Merck, that the record shows that 31 percent of all TRICARE
prescriptions are filled at retail network pharmacies, and that these
prescriptions represent 52 percent of TRICARE's expenditures for
prescription drugs.  AR, Tab C.40, at 6.  Given the significant proportion
of TRICARE prescriptions filled at network retail pharmacies, together
with the statutory and regulatory mandate to consider the cost
effectiveness of these agents when considering whether to include them on
the uniform formulary, we see nothing unreasonable in the agency's
decision to consider their cost when they are obtained by beneficiaries at
retail network pharmacies.  In addition, and for the same reasons, we
think this decision is well within the discretion given TRICARE
authorities, and can, in no way, be termed a violation of the pharmacy
benefit statute.

   We also disagree with Merck's contention that the decision to evaluate the
cost of agents dispensed via retail network pharmacies in making formulary
decisions in some way renders invalid the request for price quotations, or
the anticipated BPA.  In Merck's view, considering the cost of agents
dispensed at retail network pharmacies "creates a fundamental disconnect
between the requirements covered by the RFQ and the costs to be included
in the evaluation."  Protester's Comments, Mar. 21, 2005, at 20.

   The problem with Merck's characterization of this situation is that the
agency's requirements here, as discussed below, are broader than the
subset of purchases encompassed by this quotation request.  Moreover, we
think Merck's implicit suggestion that the "award decision" should be
based only on information solicited by the quotation request ignores the
limited purpose of both the quotations requested, and any BPA that
results. 

   The agency here has a requirement to provide ARBs to TRICARE
beneficiaries, and it meets this requirement through three distinct
dispensing venues--only two of which (MTFs and the TMOP) can purchase
pharmaceutical agents using the FSS.  In addition, the agency seeks to
quantify the costs associated with dispensing agents from all three of
these venues as part of deciding which agents it will include on its
formulary--a goal we view as reasonable, and consistent with the statute's
mandate to consider costs.  The quotation request used here simply imports
pricing information (from manufacturers willing to provide it) to inform
that formulary decision, and the BPA that results, if any, provides a
mechanism to obtain for MTFs and the TMOP the prices that were used to
make the formulary selection decision. 

   As Merck recognizes, nothing about this price quotation request, or any
BPA that results from it, can provide private-sector retail network
pharmacies the right to order pharmaceutical agents using the government's
FSS contracts with manufacturers, including the government's FSS contract
with Merck.  For this reason, nothing about this quotation request is
legally invalid or improper because it does not solicit a quotation from
manufacturers for the cost of these agents when procured by beneficiaries
via retail network pharmacies (in fact, if TRICARE had solicited such a
quotation, it would, under current circumstances, essentially be
meaningless).  We also see nothing invalid about this request simply
because the evaluation the P&T Committee undertakes to make a formulary
determination will consider other costs (i.e., those paid at retail
network pharmacies), and a host of other information not solicited here. 
In short, we see nothing improper about TRICARE's approach of soliciting
quotations to inform its formulary decision about the costs that will be
incurred in two of the three applicable dispensing venues, and not
soliciting quotations for the retail network pharmacy portion of the cost
equation. 

   Merck next argues that, in the event our Office agrees that TRICARE can
consider the cost of pharmaceutical agents dispensed via retail network
pharmacies in making formulary decisions--and we do--we should nonetheless
determine that TRICARE's use of the Federal Ceiling Price of such agents
for its determination is improper. 

   Given our view that TRICARE's decision to consider the cost of
pharmaceutical agents dispensed via retail network pharmacies was within
its discretion to implement its statutory mandate to establish a uniform
formulary, we think the agency also enjoys reasonable discretion in its
attempt to quantify what these costs might be.  Again, as with the
decision to consider such costs, Merck correctly points out that there is
nothing in the statute or the implementing regulations that requires
TRICARE to consider the Federal Ceiling Price in its review of cost
effectiveness.  Nonetheless, we begin by noting that the statute delegates
to the agency the discretion to develop appropriate procedures in its
implementing regulations.  10 U.S.C. S 1074g(a)(2)(D).  These regulations
identify the information that may be reviewed, but do not limit the
information that can be considered to that identified.  32 C.F.R. S
199.21(e)(2)(ii).  Within these regulations, the very first type of
information identified as appropriate in a cost effectiveness review is
the cost of the agent to the government.  Id.

   In this regard--and in a decision with far broader consequences than
simply the determination of what pharmaceutical agents will be selected
for the uniform formulary--the Secretary of the VA has issued a written
finding that, in his view, certain provisions of the Veterans Health Care
Act of 1992 (which are now codified at 38 U.S.C. S 8126(h)(3)) apply to
the prescriptions filled under TRICARE's Retail Pharmacy Program.  AR, Tab
C.3, at 2, C.21.  As explained by both TRICARE and Merck, DOD has begun
using this authority to seek refunds from pharmaceutical manufacturers for
the costs paid by TRICARE for beneficiaries' prescriptions that exceed the
amount of the Federal Ceiling Price.  The VA decision is under challenge
elsewhere by Merck and other pharmaceutical manufacturers.

   That said, our bid protest forum is not the venue to litigate decisions of
the VA Secretary extending the applicability of the Veterans Health Care
Act to the TRICARE Retail Pharmacy Program.  For our review is the far
more limited issue of whether TRICARE acted unreasonably in deciding to
use the Federal Ceiling Price as an estimate of the cost it will pay for
prescriptions filled by beneficiaries at network retail pharmacies in
making its formulary determination.  While the VA Secretary's decision may
be the subject of litigation elsewhere, unless and until the decision is
overturned, we are not sure TRICARE reasonably could have acted in a
manner inconsistent with this decision.  In addition, since the decision,
if upheld, will result in the Federal Ceiling Price being the actual price
that TRICARE will pay for these prescriptions, we cannot see how the
decision to use this figure as an estimate of future costs for the limited
purpose of selecting agents for the uniform formulary was unreasonable.

   With respect to Merck's third basis of protest--i.e., that the agency is
planning to rely on flawed historical dosing data in assessing cost for
purposes of determining whether to include an agent on the formulary--we
agree with TRICARE's response that Merck is blurring the distinction
between evaluations made in a standard procurement, and the deliberations
of the P&T Committee here.  As indicated earlier, TRICARE posted specific
information related to the P&T Committee's review of the ARB drug class. 
AR, Tab C.7.  This document advised that the committee would rely on
historical utilization data to compute an overall weighted average cost
per day of therapy with each agent.  Id. at 2.  Merck complains that the
use of historical data here could result in misleading results because
newer pharmaceutical agents may not have acquired usage in all relevant
patient profiles, and thus may have more limited dosing ranges. 

   While we are aware that there are newer agents within the ARB drug class,
as well as recent developments in the use of certain agents in this class
for the treatment of conditions other than high blood pressure,[12] we are
not prepared to conclude that the P&T Committee's reliance on historical
usage data is unreasonable.  In addition, while we recognize that the VA,
in a recent ARB procurement which was restricted to only two of the agents
in the ARB drug class, decided not to rely on its historical usage data,
see Bristol-Myers Squibb Co., supra, at 5, we do not think the VA's
approach there mandates a conclusion that the DOD approach here is
unreasonable.  In this regard, we note that the VA was procuring two ARBs
for the purpose of treating diabetic nephropathy, and was concerned that
the historical usage data would reflect the use of these agents to treat
simple hypertension.  Id.  Here, there is no suggestion that the future
use of these drugs will be limited in the same way VA limited it, so that
it is less clear that past usage might differ from usage in the future. 
In any event, it is not appropriate for us to substitute our judgment for
that of the P&T Committee about what the future usage of these drugs might
be.

   We are also struck, at this juncture, by the difference between the
formulary decisions at issue here, and those reviewed in our prior cases,
including the two cases cited above.  In those cases and others, an agency
used the procurement process to have a price competition between
pharmaceutical agents after making a determination that the agents could
be compared head-to-head, resulting in the selection of only one.  See,
e.g., Bristol-Myers Squibb Co., supra, at 5-7. 

   Here, TRICARE has selected six of the seven agents in the ARB drug class,
including Merck's Losartan, for the uniform formulary.  P&T Committee
Minutes, Feb. 16, 2005, at 20.  Given the inclusion of Merck's agent on
the uniform formulary, Merck's apparent concern about losing out on a
price competition appears to relate only to the decision about which of
these agents should be listed on the basic core formulary.  In recognition
of the fact that the basic core formulary exists to address the expected
scope of treatment to be provided in MTFs, the P&T Committee concluded
that the majority of ARB usage would be for the treatment of simple
hypertension.  Id. at 21.  As a result, the Committee selected a single
ARB based on its efficacy and cost effectiveness in treating
hypertension--not heart failure, and not diabetic nephropathy.  Id. at
22.  Based on this record we see nothing to suggest that Merck's drug
would have fared differently against the one selected for the basic core
formulary even if the historical usage data had been scrapped in some
effort to estimate future usage of newer and more refined agents.  In
short, the results of the P&T Committee review suggest that Merck was not
prejudiced by the agency's reliance on historical usage data to make its
formulary selection decision.

   Merck's fourth basis of protest is that the agency failed to explain the
relative importance of clinical effectiveness and cost in the P&T
Committee's evaluation, and that the relative importance of these two
considerations had to be identified in the request for price quotations. 
We disagree.  The statute authorizing TRICARE's pharmacy benefits program
requires that the agency make decisions about the inclusion of
pharmaceutical agents on its formulary based on a consideration of the
relative clinical and cost effectiveness of the agents.  10 U.S.C. S
1074g(a)(2)(A).  There is nothing in the statutory scheme (or in the
regulations that implement it) that identifies the relative importance of
clinical and cost effectiveness; the statute mandates only that both be
considered. 

   Similarly, there is no requirement under the statutory scheme here that
manufacturers of pharmaceutical agents be advised of the relative
importance of these two considerations.  In this regard, we disagree with
Merck's contention that our decision in COMARK Federal Sys., B-278343,
B-278343.2, Jan. 20, 1998, 98-1 CPD P 34, requires the inclusion of an
evaluation scheme in the request for price quotations used here.  As we
explained in COMARK, when an agency reviews competing vendors' schedule
offerings, but does not shift to vendors the burden of selecting items to
propose, there is no requirement that vendors be given notice of the
agency's needs or the selection criteria; a requirement to identify
selection criteria arises when vendors are called upon to select a
particular configuration among multiple possibilities with no guidance
about how to do so intelligently.  Id. at 4-5. 

   Here, Merck sells its ARB under its FSS contract; admittedly, it sells
this ARB in 25, 50, and 100 mg. tablets.  TRICARE has asked for a price
quotation that could result in additional price reductions (which will be
reflected in a BPA) because the agency assumes that selecting a
manufacturer's ARB for inclusion on the uniform formulary will generate
repetitive purchases.  Merck need consider no configuration of different
products, nor any particular configuration of its tablet sizes; it simply
needs to consider whether a higher volume of sales might provide a basis
to offer a reduction from its existing FSS prices.  We know of no
evaluation criterion it needs to make this assessment.

   Merck's final basis of protest is that the agency has unreasonably
concluded that it will not consider alternative price quotations for its
formulary deliberations.  Again, we disagree. 

   In the December 22 letter to pharmaceutical manufacturers, and in the
generic Uniform Formulary BPA Information (AR, Tabs C.3 and C.8,
respectively) posted on the website, TRICARE advised manufacturers that
the P&T Committee would not accept multiple, conditional, or market
share-based price quotations at this time.  The record here reflects that
TRICARE received requests from Merck, and other manufacturers, that it
reconsider this restriction, and that the agency decided not to do so. 

   As indicated above, the template for submission of price quotations used
here, AR, Tab C.9 at 3, allowed manufacturers to provide both an MTF and a
TMOP price for their agents if included on the uniform formulary;
manufacturers were also allowed to submit a second MTF price if included
on the basic core formulary.  In Merck's view, TRICARE abused its
discretion by not also allowing submission of quotations contingent upon
being the only agent selected for the formulary.    

   In response to Merck's contention, TRICARE submitted an affidavit from one
of its analysts working in support of the P&T Committee.  In the
affidavit, the analyst explains that there was concern within the agency
that the acceptance of multiple price quotations from a single
manufacturer would significantly increase the complexity of the analysis
of the relative cost effectiveness of the agents within this class, and
that doing so would unduly complicate the committee's deliberations. 
Affidavit of Pharmacoeconomic Center Analyst, Mar. 8, 2005, at 4.  There
was also a concern that granting requests for multiple contingent
quotations[13] could require extending the deadline for submission of
price quotations in order to allow the companies additional time, and that
doing so could result in postponing the long-scheduled meeting of the P&T
Committee with a ripple effect on patient appointments with physician
members of the committee.  Id.  To emphasize the importance of this ripple
effect, the affiant explained that more than 700 patient appointments were
not scheduled in order to permit the P&T Committee's physician members to
attend the meeting.  Id.  Finally, the affiant expressed his opinion that
manufacturers faced with only a single price quotation option, in the
midst of substantial competition, might be more inclined to give a better
price than they would if faced with multiple nuanced options.  Id. at 4-5.

   Merck correctly points out that there is evidence in this record that
certain officials in the agency believe it might be appropriate to adjust
the format of the template for future formulary deliberations to permit
submission of multiple contingent quotations.  On the other hand, even the
e-mails in the agency record which Merck highlights as evidence of agency
agreement with its position show careful weighing of numerous competing
considerations.  See, e.g., AR, Tab C.31 (earlier e-mail from the affiant
discussed above indicated that TRICARE's decision not to make this change
would likely "leave money on the table").  Our review of these documents
shows a thoughtful consideration of the implications of permitting
multiple contingent quotations, followed by a decision to knowingly opt
for a somewhat conservative approach in this first attempt to complete a
formulary review under the new statute.  We see nothing in these documents
to support a conclusion that the agency was acting arbitrarily, or in any
way unreasonably, by not accepting, at this juncture, multiple,
conditional, or market share-based price quotations. 

   The protest is denied.

   Anthony H. Gamboa

   General Counsel

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

   [1] The statute and regulations at issue here refer to individual drugs
within a drug class as pharmaceutical agents.  We will use this
nomenclature within this decision. 

   [2] Bristol-Myers Squibb Co., a manufacturer of one of the pharmaceutical
agents at issue in this matter, intervened in this protest on a limited
basis in support of Merck.  We permitted this limited intervention
pursuant to our discretionary authority at 4 C.F.R. S 21.3(j) (2005).

   [3] In addition, TRICARE advises, and our review confirms, that its
actions implementing its statutory authorization to create a uniform
formulary have not been previously challenged in any forum on any basis. 
AR at 5.

   [4] There is another subset of the uniform formulary, called the extended
core formulary, which also applies only to MTFs.  Merck advises that the
extended core formulary is not relevant to its challenges here.  Initial
Protest, Feb. 4, 2005, at 9 n.7.  Accordingly, we need not discuss it
further.

   [5] TRICARE beneficiaries may also get their prescriptions filled at
non-network retail pharmacies, but if they do, their co-payment for
generic and formulary agents is $9, or 20 percent of the cost (whichever
is greater), and their co-payment for non-formulary agents is $22, or 20
percent of the cost (whichever is greater).  32 C.F.R. S
199.21(i)(2)(iii)-(iv).

   [6] In certain circumstances, manufacturers of pharmaceutical agents are
required by statute to make their products available under the FSS, and to
provide price discounts to the DOD, the Department of Veterans Affairs
(VA), the Public Health Service (PHS), and the Coast Guard (collectively,
the "Big Four").  38 U.S.C. S 8126.

   [7] The Federal Ceiling Price is the term used to describe certain
discounts anticipated by 38 U.S.C. S 8126(a)(2) (a price that "may not
exceed 76 percent of the non-Federal average manufacturer price. . . ."). 
This price may (but may not always) result in a deeper price discount for
the government than the price of pharmaceutical agents found on the "Big
Four" FSS, and is available to the government for purchases made via a
"depot contracting system," as defined at 38 U.S.C. S 8126(h).

   [8] In support of its assertion, Merck appended to its initial protest, at
attachment L, a January 12, 2005, letter from the American Bar
Association's Section of Public Contract Law to the Director of the Office
of Federal Procurement Policy arguing that the VA decision requires the
use of "notice and comment" rulemaking procedures before it can be
implemented.  Merck also submitted other documents related to this ongoing
dispute during the course of the protest.

   [9] In essence, these orders will be "teed up" by the BPA that results
from this selection decision, so that the agency will be able to place
multiple repetitive orders for the pharmaceutical agents, as anticipated
by FAR S 8.404(b)(4).

   [10] In fact, the requirement that all MTFs stock, and provide with no
co-payment, all pharmaceutical agents placed on the basic core formulary,
see 10 U.S.C. S 1074g(a)(2)(E)(i); 32 C.F.R. S 199.21(h)(2)(ii), will
translate almost immediately to FSS purchases by MTFs. 

   [11] Merck refers to all of the information posted at the DOD's
Pharmacoeconomic Center website collectively as the "RFQ."  In our view,
Merck's use of the term RFQ does not capture the distinction between
general process information disseminated by TRICARE about its approach to
this and subsequent formulary reviews, information related to this
particular review, and information related to the specific BPA anticipated
here.  In the discussion below we will refer to the source of each
disputed provision by name, with a citation to its placement in the agency
report.

   [12] See Boehringer Ingelheim Pharm., Inc., B-294944.3, B-295430, Feb. 2,
2005, 2005 CPD P 32 at 2-3 (two of the seven agents within the ARB drug
class, including Merck's Losartan, have been shown to also be effective in
the treatment of diabetic nephropathy, and two others have been shown to
be effective in the treatment of heart failure); Bristol-Myers Squibb Co.,
B-294944.2, Jan. 18, 2005, 2005 CPD P 16 at 3 (same).  

   [13] For example, one ARB manufacturer, not Merck, asked to be allowed to
submit one price if its agent was the sole ARB on the basic core formulary
(BCF), a slightly higher price if its ARB was one of two selected for the
BCF, and a slightly higher price again if its ARB was one of three
selected for the BCF.  Id. at 3.