Court Opinion

ID: 213504
Source: CourtListenerOpinion
Date Created: 2011-03-29 14:25:58+00
Date Added: 2024-06-11T17:28:15.960834
License: Public Domain

(Slip Opinion)              OCTOBER TERM, 2010                                       1

                                       Syllabus

         NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
       being done in connection with this case, at the time the opinion is issued.
       The syllabus constitutes no part of the opinion of the Court but has been
       prepared by the Reporter of Decisions for the convenience of the reader.
       See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.

SUPREME COURT OF THE UNITED STATES

                                       Syllabus

  ASTRA USA, INC., ET AL. v. SANTA CLARA COUNTY, 

                    CALIFORNIA 

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
                  THE NINTH CIRCUIT

   No. 09–1273. Argued January 19, 2011—Decided March 29, 2011
Section 340B of the Public Health Services Act imposes ceilings on
  prices drug manufacturers may charge for medications sold to speci
  fied health care facilities (340B or covered entities), dominantly, local
  providers of medical care for the poor. The §340B ceiling-price pro
  gram (340B Program) is superintended by the Health Resources and
  Services Administration (HRSA), part of the Department of Health
  and Human Services (HHS). It is tied to the earlier-enacted, much
  larger Medicaid Drug Rebate Program, under which manufacturers
  gain Medicaid coverage for their drugs. To qualify for participation
  in this program, a manufacturer must enter into a standardized
  agreement with HHS undertaking to provide rebates to States on
  their Medicaid drug purchases. The amount of the rebates depends
  on a manufacturer’s “average” and “best” prices, as defined by legisla
  tion and regulation. The 340B Program, like the Medicaid Rebate
  Program, uses a form contract as an opt-in mechanism. The 340B
  Program also draws on the larger scheme’s pricing methodology. In
  the 340B Program’s contract, called the Pharmaceutical Pricing
  Agreement (PPA), manufacturers agree to charge covered entities no
  more than predetermined ceiling prices, derived from the “average”
  and “best” prices and rebates calculated under the Medicaid Rebate
  Program.
     HRSA may require a manufacturer who overcharges a covered en
  tity to reimburse that entity. HRSA may also terminate the manu
  facturer’s PPA, which terminates as well the manufacturer’s eligibil
  ity for Medicaid coverage of its drugs. Currently, HRSA handles
  overcharge complaints through informal procedures, but the 2010 Pa
  tient Protection and Affordable Care Act (PPACA) directs the Secre
2            ASTRA USA, INC. v. SANTA CLARA COUNTY

                                 Syllabus

    tary to develop formal procedures. Once those procedures are in
    place, HRSA will reach an “administrative resolution,” which will be
    subject to judicial review under the Administrative Procedure Act
    (APA). In addition to authorizing compensation awards to over
    charged entities, the PPACA provides for the imposition of monetary
    penalties payable to the Government.
       Respondent Santa Clara County (County), operator of several 340B
    entities, filed suit against Astra and eight other pharmaceutical com
    panies, alleging that they were overcharging 340B entities in viola
    tion of the PPAs. Asserting that 340B entities are the PPAs’ in
    tended beneficiaries, the County sought compensatory damages for
    breach of contract. The District Court dismissed the complaint, con
    cluding that the PPAs conferred no enforceable rights on 340B enti
    ties. Reversing, the Ninth Circuit held that, while 340B entities have
    no right to sue under the statute, they could proceed against drug
    manufacturers as third-party beneficiaries of the PPAs.
Held: Suits by 340B entities to enforce ceiling-price contracts running
 between drug manufacturers and the Secretary of HHS are incom
 patible with the statutory regime. As the County has conceded, cov
 ered entities have no right of action under §340B itself. Congress
 vested authority to oversee compliance with the 340B Program in
 HHS and assigned no auxiliary enforcement role to covered entities.
 Nonetheless, the County maintains that the PPAs are contracts en
 forceable by covered entities as third-party beneficiaries. This argu
 ment overlooks that the PPAs simply incorporate statutory obliga
 tions and record the manufacturers’ agreement to abide by them.
 The agreements have no negotiable terms. Like the Medicaid Rebate
 Program agreements, the PPAs provide the means by which drug
 manufacturers opt into the statutory scheme. A third-party suit to
 enforce an HHS-drug manufacturer agreement, therefore, is in es
 sence a suit to enforce the statute itself. Telling in this regard, the
 County based its suit on allegations that the manufacturers charged
 more than the §340B ceiling price, not that they violated an inde
 pendent substantive obligation arising from the PPAs.
    The Ninth Circuit reasoned that suits like the County’s would
 spread the enforcement burden instead of placing it entirely on the
 Government. But spreading the enforcement burden is hardly what
 Congress contemplated when it made HHS administrator of the in
 terdependent Medicaid Rebate Program and 340B Program. Suits by
 340B entities would undermine the agency’s efforts to administer
 these two programs harmoniously and uniformly. Notably, the Medi
 caid Rebate Program’s statute prohibits HHS from disclosing pricing
 information that could reveal the prices a manufacturer charges for
 its drugs. Had Congress meant to leave open the prospect of third
                     Cite as: 563 U. S. ____ (2011)                  3

                               Syllabus

  party beneficiary suits by 340B entities, it likely would not have
  barred them from obtaining the very information necessary to deter
  mine whether their asserted rights have been violated.
    The Ninth Circuit noted that HHS’s Office of the Inspector General
  has reported on HRSA’s inadequate enforcement authority. But
  Congress did not respond to the reports of lax enforcement by invit
  ing 340B entities to launch lawsuits. Instead, Congress opted to
  strengthen and formalize HRSA’s enforcement authority, to make the
  new adjudicative framework the proper remedy for covered entities’
  complaints, and to render the agency’s resolution of those complaints
  binding, subject to judicial review under the APA. Pp. 5–10.
588 F. 3d 1237, reversed.

   GINSBURG, J., delivered the opinion of the Court, in which all other
Members joined, except KAGAN, J., who took no part in the considera
tion or decision of the case.
                       Cite as: 563 U. S. ____ (2011)                              1

                            Opinion of the Court

    NOTICE: This opinion is subject to formal revision before publication in the
    preliminary print of the United States Reports. Readers are requested to
    notify the Reporter of Decisions, Supreme Court of the United States, Wash­
    ington, D. C. 20543, of any typographical or other formal errors, in order
    that corrections may be made before the preliminary print goes to press.

SUPREME COURT OF THE UNITED STATES
                                  _________________

                                  No. 09–1273
                                  _________________

  ASTRA USA, INC., ET AL., PETITIONERS v. SANTA 

         CLARA COUNTY, CALIFORNIA 

 ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF 

            APPEALS FOR THE NINTH CIRCUIT

                               [March 29, 2011] 

   JUSTICE GINSBURG delivered the opinion of the Court.
   Section 340B of the Public Health Services Act, 42
U. S. C. A. §256b (Oct. 2010 Supp.), imposes ceilings on
prices drug manufacturers may charge for medications
sold to specified health care facilities. Those facilities,
here called “340B” or “covered” entities, include public
hospitals and community health centers, many of them
providers of safety-net services to the poor. The §340B
ceiling-price program (340B Program) is superintended by
the Health Resources and Services Administration
(HRSA), a unit of the Department of Health and Human
Services (HHS). Drug manufacturers opt into the 340B
Program by signing a form Pharmaceutical Pricing
Agreement (PPA) used nationwide. PPAs are not transac­
tional, bargained-for contracts. They are uniform agree­
ments that recite the responsibilities §340B imposes,
respectively, on drug manufacturers and the Secretary of
HHS. Manufacturers’ eligibility to participate in state
Medicaid programs is conditioned on their entry into PPAs
for covered drugs purchased by 340B entities.
   It is conceded that Congress authorized no private right
2        ASTRA USA, INC. v. SANTA CLARA COUNTY

                     Opinion of the Court

of action under §340B for covered entities who claim they
have been charged prices exceeding the statutory ceiling.
This case presents the question whether 340B entities,
though accorded no right to sue for overcharges under the
statute itself, may nonetheless sue allegedly overcharging
manufacturers as third-party beneficiaries of the PPAs to
which the manufacturers subscribed. We hold that suits
by 340B entities to enforce ceiling-price contracts running
between drug manufacturers and the Secretary of HHS
are incompatible with the statutory regime.
   Congress placed the Secretary (acting through her
designate, HRSA) in control of §340B’s drug-price pre­
scriptions. That control could not be maintained were
potentially thousands of covered entities permitted to
bring suits alleging errors in manufacturers’ price calcula­
tions. If 340B entities may not sue under the statute, it
would make scant sense to allow them to sue on a form
contract implementing the statute, setting out terms
identical to those contained in the statute. Though labeled
differently, suits to enforce §340B and suits to enforce
PPAs are in substance one and the same. Their treat­
ment, therefore, must be the same, “[n]o matter the cloth­
ing in which [340B entities] dress their claims.” Tenet v.
Doe, 544 U. S. 1, 8 (2005).
                              I

                             A

   The 340B Program is tied to the earlier-enacted, much
larger Medicaid Drug Rebate Program. Adopted by Con­
gress in 1990, the Medicaid Rebate Program covers a
significant portion of drug purchases in the United States.
See GAO, J. Dicken, Prescription Drugs: Oversight of
Drug Pricing in Federal Programs 1 (GAO–07–481T, 2007)
(testimony before the Committee on Oversight and Gov­
                     Cite as: 563 U. S. ____ (2011)                   3

                         Opinion of the Court

ernment Reform, House of Representatives).1 To gain
payment under Medicaid for covered drugs, a manufac­
turer must enter a standardized agreement with HHS; in
the agreement, the manufacturer undertakes to provide
rebates to States on their Medicaid drug purchases. 104
Stat. 1388–143, as amended, 124 Stat. 3290, 42 U. S. C. A.
§1396r–8(a). The amount of the rebates depends on the
manufacturer’s “average” and “best” prices, as defined by
legislation and regulation. §1396r–8(c), (k).
   Calculation of a manufacturer’s “average” and “best”
prices, undertaken by the pharmaceutical company, is a
complex enterprise requiring recourse to detailed informa­
tion about the company’s sales and pricing. §1396r–8(k);
42 CFR §447.500–520 (2010). To enable HHS to calcu-
late the rebate rate for each drug, manufacturers submit
the relevant data to HHS on a quarterly basis. §1396r–
8(b)(3). With exceptions set out in the legislation, HHS is
prohibited from disclosing the submitted information “in a
form which discloses the identity of a specific manufac­
turer . . . [or] prices charged for drugs by such manu­
facturer.” §1396r–8(b)(3)(D).
   Under §340B, added in 1992, 106 Stat. 4967, as
amended, 124 Stat. 823, manufacturers participating in
Medicaid must offer discounted drugs to covered entities,
dominantly, local facilities that provide medical care for
the poor. See §256b(a); §1396r–8(a)(1). The 340B Pro­
gram, like the Medicaid Drug Rebate Program, employs a
form contract as an opt-in mechanism. The 340B Program
also draws on the larger scheme’s pricing methodology. In
their 340B Program contracts with HHS, called Pharma­
——————
   1“In 2004, Medicaid . . . prescription drug spending reached $31 bil­

lion,” GAO, J. Dicken, Prescription Drugs: Oversight of Drug Pricing
in Federal Programs 4 (GAO–07–481T, 2007) (testimony before the
Committee on Oversight and Government Reform, House of Represen­
tatives), while in 2003, 340B entities “spent an estimated $3.4 billion
on drugs,” id., at 5.
4           ASTRA USA, INC. v. SANTA CLARA COUNTY

                         Opinion of the Court

ceutical Pricing Agreements (PPAs), see supra, at 1,
manufacturers agree to charge covered entities no more
than predetermined ceiling prices, derived from the “aver­
age” and “best” prices and rebates calculated under the
Medicaid Drug Rebate Program. §256b(a)(1); see App. to
Pet. for Cert. 165a–171a (PPA §I–II).2
   If a manufacturer overcharges a covered entity, HRSA
may require the manufacturer to reimburse the covered
entity; HRSA may also terminate the manufacturer’s PPA,
§1396r–8(b)(4)(B)(i), (v); App. to Pet. for Cert. 174a (PPA
§IV(c)), which terminates as well the manufacturer’s
eligibility for Medicaid coverage of its drugs, §1396r–
8(a)(1), (5). Currently, HRSA handles overcharge com­
plaints through informal procedures. Manufacturer Audit
Guidelines and Dispute Resolution Process, 61 Fed. Reg.
65412 (1996). The 2010 Patient Protection and Affordable
Care Act (PPACA), Pub. L. 111–148, 124 Stat. 119, pro­
vides for more rigorous enforcement. The PPACA directs
the Secretary to develop formal procedures for resolving
overcharge claims. Id., at 826, 42 U. S. C. A. §256b(d)
(3)(A). Under those procedures, which are not yet in place,
HRSA will reach an “administrative resolution” that is
subject to judicial review under the Administrative Proce­
dure Act (APA), 5 U. S. C. §701 et seq. See 124 Stat. 827,
42 U. S. C. A. §256b(d)(3)(C). In addition to authorizing
compensation awards to overcharged entities, the PPACA
provides for the imposition of monetary penalties pay­
able to the Government. Id., at 824–825, 42 U. S. C. A.
§256b(d)(1)(B)(ii), (vi).
                           B
    Respondent Santa Clara County (County), operator of
——————
    2 The
        340B Program also covers over-the-counter medications for
which there are no Medicaid rebates. 42 U. S. C. A. §256b(a)(2)(B) (Oct.
2010 Supp.). For such drugs, §340B prescribes a substitute calculation
method. §256b(a)(2)(B)(i).
                     Cite as: 563 U. S. ____ (2011)                     5

                          Opinion of the Court

several 340B entities, commenced suit against Astra and
eight other pharmaceutical companies, alleging that the
companies were overcharging 340B health care facilities
in violation of the PPAs to which the companies sub­
scribed. The County styled its suit a class action on behalf
of both 340B entities in California and the counties that
fund those entities. Asserting that the 340B entities and
the counties that fund them are the intended beneficiaries
of the PPAs, the County sought compensatory damages for
the pharmaceutical companies’ breach of contract.
   The District Court dismissed the complaint, concluding
that the PPAs conferred no enforceable rights on 340B
entities. Reversing the District Court’s judgment, the
Ninth Circuit held that covered entities, although they
have no right to sue under the statute, could maintain the
action as third-party beneficiaries of the PPAs. 588 F. 3d
1237, 1241 (2009).
   We granted certiorari, 561 U. S. ___ (2010),3 and now
reverse the Ninth Circuit’s judgment.
                             II
  As the County conceded below and before this Court, see
588 F. 3d, at 1249; Tr. of Oral Arg. 45, covered entities
have no right of action under §340B itself. “[R]ecognition
of any private right of action for violating a federal stat­
ute,” currently governing decisions instruct, “must ulti­
mately rest on congressional intent to provide a private
remedy.” Virginia Bankshares, Inc. v. Sandberg, 501 U. S.
——————
  3 U. S. Courts of Appeals have divided on the circumstances under

which suits may be brought by alleged third-party beneficiaries of
Government contracts. Compare 588 F. 3d 1237, 1244 (CA9 2009) (case
below) (“Any intended beneficiary has the right to enforce the obligor’s
duty of performance . . . .”), with Grochowski v. Phoenix Construction,
318 F. 3d 80, 85–86 (CA2 2003) (“there is no presumption in favor of a
right to bring suit” as third-party beneficiary of a government contract),
and Dewakuku v. Martinez, 271 F. 3d 1031, 1042 (CA Fed. 2001)
(rejecting third-party suit).
6        ASTRA USA, INC. v. SANTA CLARA COUNTY

                     Opinion of the Court

1083, 1102 (1991). See also Stoneridge Investment Part
ners, LLC v. Scientific-Atlanta, Inc., 552 U. S. 148, 164
(2008); Alexander v. Sandoval, 532 U. S. 275, 286 (2001).
Congress vested authority to oversee compliance with the
340B Program in HHS and assigned no auxiliary enforce­
ment role to covered entities.
   Notwithstanding its inability to assert a statutory right
of action, the County maintains that the PPAs implement­
ing the 340B Program are agreements enforceable by
covered entities as third-party beneficiaries. A nonparty
becomes legally entitled to a benefit promised in a
contract, the County recognizes, only if the contracting
parties so intend. Brief for Respondent 31 (citing Re­
statement (Second) of Contracts §302(1)(b) (1979)). The
PPAs “specifically nam[e]” covered entities as the recipi­
ents of discounted drugs, the County observes; indeed the
very object of the agreements is to ensure that those enti­
ties would be “charge[d] . . . no more than the ceiling
price.” Brief for Respondent 33. When the Government
uses a contract to secure a benefit, the County urges, the
intended recipient acquires a right to the benefit enforce­
able under federal common law. Id., at 30. But see 9 J.
Murray, Corbin on Contracts §45.6, p. 92 (rev. ed. 2007)
(“The distinction between an intention to benefit a third
party and an intention that the third party should have
the right to enforce that intention is emphasized where
the promisee is a governmental entity.”).
   The County’s argument overlooks that the PPAs simply
incorporate statutory obligations and record the manufac­
turers’ agreement to abide by them. The form agree­
ments, composed by HHS, contain no negotiable terms.
Like the Medicaid Drug Rebate Program agreements, see
supra, at 3, the 340B Program agreements serve as the
means by which drug manufacturers opt into the statutory
scheme. A third-party suit to enforce an HHS-drug manu­
facturer agreement, therefore, is in essence a suit to en­
                     Cite as: 563 U. S. ____ (2011)                     7

                          Opinion of the Court

force the statute itself. The absence of a private right to
enforce the statutory ceiling price obligations would be
rendered meaningless if 340B entities could overcome that
obstacle by suing to enforce the contract’s ceiling price
obligations instead. The statutory and contractual obliga­
tions, in short, are one and the same. See Grochowski v.
Phoenix Construction, 318 F. 3d 80, 86 (CA2 2003) (when
a government contract confirms a statutory obligation, “a
third-party private contract action [to enforce that obliga­
tion] would be inconsistent with . . . the legislative scheme
. . . to the same extent as would a cause of action directly
under the statute” (internal quotation marks omitted)).
    Telling in this regard, the County based its suit on
allegations that the manufacturers charged more than the
§340B ceiling price, see, e.g., Third Amended Complaint in
No. 3:05–cv–03740 (ND Cal.), ¶1, 65, not that they vio­
lated any independent substantive obligation arising only
from the PPAs.4 Repeatedly, the County acknowledged
that §340B is the source of the contractual term allegedly
breached. See, e.g., id., ¶28 (“[Section] 340B requires
pharmaceutical manufacturers to ensure that §340B
Participants pay no more than the ‘ceiling price’ . . . for
any pharmaceutical product.”); id., ¶36 (“Under both
§340B and the PPA, [drug manufacturers] are required to
ensure that the §340B Participants . . . pay no more for
any product than the §340B ceiling price.”).
——————
  4 Whether   a contracting agency may authorize third-party suits to
enforce a Government contract is not at issue in this case. Cf. Brief for
United States as Amicus Curiae 22. We can infer no such authorization
where a contract simply incorporates statutorily required terms and
otherwise fails to demonstrate any intent to allow beneficiaries to en­
force those terms. Permitting such a suit, it is evident, would “allo[w]
third parties to circumvent Congress’s decision not to permit private
enforcement of the statute.” Id., at 23–24; cf. Brief for United States as
Amicus Curiae in No. 09–15216 (CA9), p. 21 (“In drafting and entering
into [PPAs], HHS never imagined that a 340B entity could bring a
third-party beneficiary lawsuit like [the County]’s.”).
8          ASTRA USA, INC. v. SANTA CLARA COUNTY

                         Opinion of the Court

   The Ninth Circuit determined that “[p]ermitting covered
entities to sue as intended beneficiaries of the PPA is . . .
wholly compatible with the Section 340B program’s objec­
tives” to ensure “that drug companies comply with their
obligations under the program and provide [the required]
discounts.” 588 F. 3d, at 1251. Suits like the County’s,
the Court of Appeals reasoned, would spread the enforce­
ment burden instead of placing it “[entirely] on the gov­
ernment.” Ibid. (citing Price v. Pierce, 823 F. 2d 1114,
1121 (CA7 1987)). But spreading the enforcement burden,
the United States stressed, both in the Ninth Circuit and
in this Court, is hardly what Congress contemplated when
it “centralized enforcement in the government.” Brief for
United States as Amicus Curiae 32; see Brief for United
States as Amicus Curiae in No. 09–15216 (CA9), p. 13
(County’s challenge is at odds with Congress’ unitary
administrative and enforcement scheme).5
   Congress made HHS administrator of both the Medicaid
Drug Rebate Program and the 340B Program, the United
States observed, Brief for United States as Amicus Curiae
33–34, and “[t]he interdependent nature of the two pro­
grams’ requirements means that an adjudication of rights
under one program must proceed with an eye towards any
implications for the other,” id., at 34. Far from assisting
HHS, suits by 340B entities would undermine the agency’s
efforts to administer both Medicaid and §340B harmoni­

——————
  5 The County notes that in In re Pharmaceutical Industry Average

Wholesale Price Litigation, 263 F. Supp. 2d 172 (Mass. 2003), the
United States urged that the statute establishing the Medicaid Drug
Rebate Program, §1396r–8, does not preempt States from maintaining
state-law fraud claims based on fraudulent reporting of “best prices” to
HHS. Brief for Respondent 22–23. See Brief for United States as
Amicus Curiae in No. 1:01–cv–12257 (D Mass.), pp. 6–9 (observing that
States make their own payments to manufacturers and have long
played a role in identifying and prosecuting Medicaid fraud). We take
no position on this issue.
                     Cite as: 563 U. S. ____ (2011)                     9

                          Opinion of the Court

ously and on a uniform, nationwide basis.6 Recognizing
the County’s right to proceed in court could spawn a mul­
titude of dispersed and uncoordinated lawsuits by 340B
entities. With HHS unable to hold the control rein, the
risk of conflicting adjudications would be substantial.
   As earlier noted, see supra, at 3, the Medicaid Rebate
Program’s statute prohibits HHS from disclosing pricing
information in a form that could reveal the prices a manu­
facturer charges for drugs it produces. §1396r–8(b)(3)(D).7
This ban on disclosure is a further indication of the in­
compatibility of private suits with the statute Congress
enacted. If Congress meant to leave open the prospect of
third-party beneficiary suits by 340B entities, it likely
would not have barred the potential suitors from obtaining
the very information necessary to determine whether their
asserted rights have been violated.8
   It is true, as the Ninth Circuit observed, that HHS’s
——————
   6 Because the Ninth Circuit focused on the 340B Program in isolation,

it failed to recognize that the interests of States under the Medicaid
Drug Rebate Program and covered entities under the 340B Program
may conflict. For example, “average” prices are used both to set the
amount manufacturers must pay in Medicaid rebates and to establish
§340B ceiling prices. §1396r–8(c); §256b(a)(1). Typically, the lower the
“average” price, the lower a product’s price to a 340B entity. Brief for
United States as Amicus Curiae in No. 09–15216, p. 31. But the higher
the “average” price, the more a State Medicaid agency typically receives
in rebates from the manufacturers. Ibid. HHS can use its expertise to
ascertain and balance the competing interests. Id., at 31–32. Courts as
first-line decisionmakers are not similarly equipped to deal with the
whole picture.
   7 HHS interprets this provision, the United States informs us, as pro­

hibiting the agency from disclosing to covered entities the ceiling prices
calculated based on information submitted by the manufacturers. Brief
for United States as Amicus Curiae 28.
   8 Going forward, the 2010 Patient Protection and Affordable Care Act,

Pub. L. 111–148, 124 Stat. 119, in conjunction with the new adminis­
trative adjudication process directed by the Act, will require HHS to
give covered entities access to some of the information submitted by
manufacturers. Id., at 826, 42 U. S. C. A. §256b(d)(3)(B)(iii).
10        ASTRA USA, INC. v. SANTA CLARA COUNTY

                     Opinion of the Court

Office of the Inspector General (OIG) has published re­
ports finding that “HRSA lacks the oversight mechanisms
and authority to ensure that [covered] entities pay at or
below the . . . ceiling price.” 588 F. 3d, at 1242 (quoting
OIG, D. Levinson, Deficiencies in the Oversight of the
340B Drug Pricing Program ii (OEI–05–02–00072, Oct.
2005)). See also 588 F. 3d, at 1242–1243 (citing OIG, D.
Levinson, Review of 340B Prices 11 (OEI–05–02–00073,
July 2006) (estimating that covered entities overpaid $3.9
million in June 2005 alone)). But Congress did not re­
spond to the reports of inadequate HRSA enforcement by
inviting 340B entities to launch lawsuits in district courts
across the country. Instead, in the PPACA, Congress
directed HRSA to create a formal dispute resolution pro­
cedure, institute refund and civil penalty systems, and
perform audits of manufacturers. 124 Stat. 823–827, 42
U. S. C. A. §256b(d). Congress thus opted to strengthen
and formalize HRSA’s enforcement authority, to make the
new adjudicative framework the proper remedy for cov­
ered entities complaining of “overcharges and other viola­
tions of the discounted pricing requirements,” id., at 823,
42 U. S. C. A. §256b(d)(1)(A), and to render the agency’s
resolution of covered entities’ complaints binding, subject
to judicial review under the APA, id., at 827, 42 U. S. C. A.
§256b(d)(3)(C).
                        *    *      *
   For the reasons stated, the judgment of the U. S. Court
of Appeals for the Ninth Circuit is
                                                Reversed.

  JUSTICE KAGAN took no part in the consideration or
decision of this case.