Legal Document

538 U.S. 644 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAv.WALSH, ACTING COMMISSIONER, MAINE DEPARTMENT HUMAN SERVICES, ET AL. No. 01-188. Supreme Court of United States. Argued January 22, 2003. Decided May 19, A State participating in Medicaid must have a medical assistance plan approved by the Secretary Health and Human Services (HHS). In response to increasing expenditures for prescription drugs, Congress enacted cost-saving measure 1990 that requires drug companies pay rebates States on their purchases. since supplemental rebate programs achieve additional cost savings purchases other needy citizens. The purpose "Maine Rx" Program is reduce prices state residents. Under program, Maine will attempt negotiate with manufacturers. If company does not enter into agreement, its sales be subjected "prior authorization" procedure agency approval qualify doctor's reimbursement. Petitioner, an association nonresident manufacturers, challenged program before commencement date, claiming it pre-empted Act violates negative Commerce Clause. Without resolving any factual issues, District entered preliminary injunction preventing statute's implementation, concluding, inter alia, obstacle, no matter how modest, federal program's administration sufficient establish pre-emption. First Circuit reversed. Held: judgment affirmed. 249 F. 3d 66, JUSTICE STEVENS delivered opinion respect Parts I, II, III, VI, concluding petitioner has carried burden showing probability success merits Clause claims. Its arguments — requirement constitutes impermissible extraterritorial regulation discriminates against interstate commerce order subsidize in-state retail are unpersuasive. Unlike price control statute invalidated Baldwin v. G. A. Seelig, Inc., 294 U. S. 511, affirmation struck down Healy Beer Institute, 491 324, Rx regulate out-of-state transaction express terms or inevitable effect. Nor impose disparate competitors. manufacturer cannot avoid obligation opening production facilities would receive benefit from even if did so; payments local pharmacists provide special competitors rebate-paying West Lynn Creamery, Inc. Healy, 512 186, distinguished. Pp. 668-670. STEVENS, joined SOUTER, GINSBURG, BREYER, concluded IV VII: 1 (a) answer question whether petitioner's was support Court's determine validity Maine's further proceedings may lead another result. Moreover, view as amendment Plan his becoming effective. As case comes this Court, there mere existence. Therefore, presumption valid, asked shouldered overcoming presumption. 660-662. 2 (b) At stage litigation, P. 670. 3 SOUTER Part V insufficient finding pre-empts insofar threatens coerce manufacturers reducing non-Medicaid sales. Petitioner claims potential interference benefits without serving prohibited statute. However, show serves such goal. fact, serve Medicaid-related purposes providing persons curtailing State's costs. While these basis upholding severely curtailed recipients' access, erred assuming modest impediment access invalidate program. gives substantial discretion choose proper mix amount, scope, duration limitations coverage long care services provided best interests. Alexander Choate, 469 287, 303. That decision curtail been motivated policy unrelated limit scope broad define package finance. See Beal Doe, 432 438. pre-emption designed foster public health force when appears, decided contrary, two governments pursuing common purposes. proceeding, severity patient's her choice conjecture. Thus, correctly resolved issue. 662-668. 4 BREYER obtain simply minimal quite harm though offered evidence countervailing benefit. Proper determination demand more careful balancing harms than undertook. technical misstatement legal standard should overlooked. Vacating also help ensure takes account Secretary's views proceedings, which important HHS administers better able court assemble relevant facts make predictions, law grants significant weight conclusions about consistent Medicaid's objectives. Act, those files approval. addition, "refer" under doctrine "primary jurisdiction," seeks produce informed uniform rulings allowing courts take advantage agency's specialized knowledge, expertise, central position within regulatory regime. Where, here, certain conditions satisfied, see Far East Conference States, 342 570, 574-575, raise own motion. then stay allow party initiate review. Even chooses own, desirability having consider "public interest" often factors 670-674. 5 SCALIA statutory claim rejected ground remedy failure comply obligations set forth itself: termination funding Secretary. seek enforcement authority relief only denial arbitrary, capricious, abuse discretion, otherwise unlawful. C. § 706(2)(A). 674-675. 6 THOMAS Act. premise "an obstacle accomplishment execution full objectives Congress." Hines Davidowitz, 312 52, 67. represents delicate balance between competing interests, e. g., cost. It prior authorization, consideration role administering forecloses claim. provides complete list restrictions place coverage. 42 1396r-8(d)(1). stricture authorization compliance procedures, 1396r-8(d)(5). 1396r-8(d)(1) effect grant subject drugs 1396r-8(d)(5)'s limitations. light credible conflict Given administer interpret can prevail renders void Supremacy unambiguous directly addressed Chevron Natural Resources Defense Council, 467 837, 842. Act's text read way. Indeed, adopted interpretation preclude negotiating Obstacle pre-emption's very expressly displaced therefore spoken question. where charged statute, imposes perhaps-insurmountable barrier 675-683. 7 J., announced REHNQUIST, O'CONNOR, KENNEDY, JJ., joined, VII, V, joined. filed concurring part judgment, post, p. SCALIA, 674, THOMAS, 675, opinions judgment. dissenting part, 684. 8 CERTIORARI TO THE UNITED STATES COURT APPEALS FOR FIRST CIRCUIT. 9 Carter Phillips argued cause petitioner. With him briefs were Kathleen M. Sullivan, Daniel Price, Marinn Carlson, Bruce Gerrity, Ann R. Robinson. 10 Deputy Solicitor General Kneedler amicus curiae urging reversal. brief Olson, Assistant Attorney McCallum, Lisa Schiavo Blatt, Mark B. Stern, Davies, Alex Azar Sheree Kanner, Henry Goldberg, Janice L. Hoffman. 11 Andrew Hagler, Maine, respondents. Steven Rowe, General, Paul John Brautigam, Cabanne Howard.* 12 join, GINSBURG join. 13 drugs,1 Over last several years, legislatures well made 2000, primarily intended discounted uninsured citizens but open all residents State. fund reduced participants. procedure. 14 case, constitutionality Program, alleged denies patients meaningful excluded market Maine. Instead, contends recipients requiring circumstances valid purpose, effectively regulates commerce. sustained both challenges implementation Appeals reversed, we granted certiorari because questions presented national importance. 536 956 (2002). 15 * created 1965 adding Title XIX Social Security Act.2 authorizes financial reimburse costs treatment persons. participate (Secretary). 1396a(b).3 defines categories individuals eligible specific kinds covered. §§ 1396a(a)(10), (17). "categorically needy"4 and, at option, cover "medically needy."5 16 Prior 1990, specifically address outpatient regulations guidelines "set upper limits each aggregate drugs."6 plans Secretary, some administered formularies, listing they cover. employed programs" required See, e.g., Dodson Parham, 427 Supp. 97, 100-101 (ND Ga. 1977) ("Georgia historically `formulary' or, words, restricted provider pharmacists. included reimbursed unless [the administrator Georgia program]"); Cowan Myers, 187 Cal. App. 968, 974-975, 232 Rptr. 299, 301-303 (1986) (describing 1982 California covered after authorization). These governed regulations, rather aided controlling costs.7 17 ratified practice approving containing requirements contained Omnibus Budget Reconciliation (OBRA 1990).8 new had basic parts. First, imposed general that, payments, agreements either authorized individual drugs.9 "single source drug" "innovator multiple difference manufacturer's average "best price," 15.1% price, whichever greater. U.S.C. 1396r-8(c)(1), (2). 11.1% price. 1396r-8(c)(3). 18 Second, once enters complies one exclusion restriction provisions 1396r-8(d). For example, exclude "[a]gents ... used cosmetic hair growth." 1396r-8(d)(2)(C). 19 Most allowed "as condition payment drug," 1396r-8(d)(5), require dispensed. OBRA except narrow category drugs,10 "[a] 1396r-8(d)(1)(A), so (1) telephone telecommunication device 24 hours request (2) listed excludable dispensing least 72-hour supply emergency situation, 20 1993,11 amended use formularies strict stated 24-hour formularies.12 1993 reenacted omitting, however, exception drugs. II 21 Legislature established "to State." Me. Rev. Stat. Ann., Tit. 2681 (West 2002). "the [shall] act pharmacy manager affordable qualified residents, thereby overall promoting healthy communities protecting welfare." 2681(1). enable buy pharmacies discount roughly equal 2681(4). 22 "labeler"13 selling through publicly supported "shall agreement" Commissioner (Commissioner). 2681(3). directed efforts calculated pursuant 1990. Rebates paid Commissioner, distributed compensate them prices. 2681(6). 23 do agreements, consequences: nonparticipation information Department release providers public." 2681(7). importantly our purposes, "department shall Title, permitted law, [nonparticipating] labelers." Ibid. department adopt implementing rules. 2681(14). rules proposed who "not comparable superior plan."14 explain intends appoint "Drug Utilization Review Committee," composed physicians evaluate manufactured declined agreement decide clinically appropriate authorization.15 "certainly single-source fulfills unique therapeutic function process" agreement.16 "whether particular based firmly upon considerations necessity, responsibilities Program."17 III 25 Several months 1, 2001, date Kevin Concannon, sent form letter enclosing agreement.18 Although 27 elected executing petitioner, Pharmaceutical Research Manufacturers America, representing "account 75 percent brand name States,"19 responded bringing action challenging complaint accompanied motion injunction, seven affidavits. 26 Four affidavits describe nature companies' methods distribution, emphasizing fact resident distributors, occur outside Maine.20 Three comment operation private managed organizations, describing actual adverse impact patients. executive stated: "Imposition [(PA)] curtails sharply reduces drug's share sales, PA causes shift PA. Because procedural burdens prescribing it, diminish goodwill helped over produced physician patient loyalty perhaps permanently."21 Another affidavit described organization Nevada four SmithKline's Augmentin, treat bacterial infections, 49% 18% six imposed.22 third affidavit, Dr. Howell SmithKline Beecham Corporation expressed never "for influencing pricing behavior program," use, "without regard safety efficacy, being prescribed less safe efficacious."23 Respondents' opposition Concannon's doctors. They dispute assertions concerning shares, instead Medical Director, Clifford, explained "[p]hysicians already acquainted extensive HMO/Insurance collectively nearly half state's residents" taken steps "ensure always prescribe safest most efficacious patients."24 second doctor, Richardson, he Augmentin line drug, amoxicillin effective treating ear infections 80%-85% time, "3 times expensive" amoxicillin.25 composition committee "make final clinical appropriateness recommendation Rebate Agreement."26 28 injunction. Relying 336 (1989), first held power transactions out Recognizing distributors threatened nonparticipating holding, assumed "`Department deny single recipient therapy indicated circumstances.'"27 court's view, nevertheless point added just passed might law. actually altered purposes."28 alteration served pre-emption: "No amounts (the parties disagree obstacle), Director dispensed...."29 29 disagreed analysis issue three reasons. found "no structure purpose." (CA1 2001). 24- conditions, motivation imposing irrelevant. given absence conflict, "fails advance program" "inflicting `strong medicine' preemption" Id., 76. Third, relevance motivation, furthers aim whose `income resources meet necessary services,' 1396, poor enough Medicaid." making accessible keep off minimizing expenditures. 30 reviewed "fall short establishing inflict probable harm" patients, thus pre-emption-based facial challenge. 78. did, concern affect quality subtle ways, inconveniencing physicians. preserved right renew challenge "should harmed `as applied.'" violation dormant vacated temporary stayed mandate pending review case. 31 us abused Doran Salem Inn, 422 922, 931-932 (1975). By means finally Program. conduct evidentiary hearing resolve disputes raised parties. Accordingly, contrary 32 possibility becomes effective.30 petition pending, recommending review, clarify issues. cautioned adoption rule prohibiting whenever operate population, suggested tailored Medicaid-eligible goals.31 brief, Federal Government's regardless need, goals invalid. Like interlocutory judicial assume understanding modification briefs. events, confront issues record dispositive ruling 33 is, course, different hearing, Plan. event, presumptively valid. us, existence We start Davies Warehouse Co. Bowles, 321 144, 153 (1944), ask 34 centerpiece attack allegedly threat recipients. argues, held, delivery accepting argument, relied heavily failed identify "Medicaid purpose" requirement. appears unnecessary what done. 35 argues could assumption erroneous, State, insisting necessary, To extent relying waiver theory, reliance inappropriate represented program; need offer one. Regardless bore establishing, clear showing, merits. Mazurek Armstrong, 520 972 (1997) (per curiam); cf. Benten Kessler, 505 1084, 1085 (1992) curiam) (requiring movant demonstrate likelihood merits). goal Rx. burden, face clearly goals, follow evaluation rested erroneous predicate. persuaded plainly present 36 identified interests successful become available individuals. needy" AFDC SSI benefits. There nonneedy persons, inclusive thinks be, nullify neediest segment population.32 enabling borderline aged infirm earlier, expenses reduced. members group purchase medicine, worsen, causing hardship likely end up expensive treatment. 37 obvious fostered refuses participate. demonstrates, organizations typically protect prescriptions encourage cost-effective medications diminishing efficacy."33 No doubt why States' ability amendments 1990.34 purchasing large volumes apparent manufacturers' shares results Florida. America Meadows, 304 1197 (CA11 2002).35 Avoiding obviously Government 38 costs, Cf. 1396a(a)(19) (State assure "in manner recipients"). was, incorrect impediment, "[n]o modest," expense Civ. 00-157-B-H, Pet. Cert. 68. 39 "gives coverage, `the interest recipients.'" 303 (1985). brought class handicapped Tennessee number annual days inpatient hospital 14, change beneficiaries "meaningful access" services. 302, 306. 14-day limitation fully 95% satisfied standard. 40 finding, [sic] circumstances."36 gave credence behalf reasoning Alexander, reflects 41 438 (1977), despite plaintiffs' submission nontherapeutic abortions dangerous childbirth, Pennsylvania's encouraging normal childbirth adequate justification abortion permissible contains categorical prohibition itself fashioning contours retains "considerable latitude" characterizes optional participation jointly financed program.37 health, Hillsborough County Automated Laboratories, 471 707, 715-718 (1985), "common purposes," New York Dept. Servs. Dublino, 413 405, 421 (1973). employment continued eligibility went beyond requirements. Commenting York's citizens, wrote: 43 "To Work Rules embody promote self-reliance civic responsibility, limited welfare funds spent genuinely incapacitated cope fiscal hardships enveloping many governments, lightly interfere. problems confronting society areas severe, cooperation Government, considerable latitude attempting resolution." 413. 44 nonfederal pre-emption, left possible conflicts resolution proceedings. 422-423. Similarly, government entire 45 agree impediment. refuse, Drug Committee authorization. determines required, result prescribed, conclude patients' needs indeed, adversely affected. 46 administrative transfer business products doctors produces affects proved. doctors' familiarity sector, seems unlikely. 47 Appeals' us. again reiterate sought go Along same lines, disapprove it. disallow fails Based CMS September 18, 2002,38 Until does, predict ultimate fate holding accordingly. VI 48 Whereas focused effects refusal focuses understand challenge, completely voluntary product coercion. first, regulation, second, Neither argument persuasive. 49 Writing 521 (1935), Justice Cardozo classic observation "New project legislation Vermont regulating milk acquired there." proposition majority's conclusion 324 Massachusetts beer sold neighboring cases applies elsewhere. But, stated, unlike statutes, transaction, insist sell wholesaler tying prices." F.3d, 81-82 (footnote omitted). applied accordingly applicable 50 186 (1994), assessment fluid dealers retailers proceeds dairy farmers. two-thirds assessed farmers while farmers, tax producers invalid discriminatory analogous protective tariff taxes goods imported similar locally. 51 entirely consumers. situation Lynn, VII 52 And risk irreparable harm, equities, alter request. 53 ordered. Notes: Briefs ofamici reversal Chamber Roberts, Jr., Catherine E. Stetson, Robin Conrad; International Patient Advocacy Association et al. Bert W. Rein; Long Term Care Pharmacy Alliance David Todd; Pacific Legal Foundation Deborah J. La Fetra; Washington Popeo Richard Samp. amici affirmance Thomas Reilly, Massachusetts, Linda Tomaselli Peter Leight, Attorneys respective jurisdictions follows: Botelho Alaska, Janet Napolitano Arizona, Pryor Arkansas, Bill Lockyer California, Earl I. Anzai Hawaii, Steve Indiana, Miller Iowa, Albert Chandler Kentucky, Ieyoub Louisiana, Joseph Curran, Maryland, Jennifer Granholm Michigan, Mike Hatch Minnesota, Moore Mississippi, Jeremiah (Jay) Nixon Missouri, McGrath Montana, Philip T. McLaughlin Hampshire, Patricia Madrid Mexico, Eliot Spitzer York, Drew Edmondson Oklahoma, Hardy Myers Oregon, D. Michael Fisher Pennsylvania, Sheldon Whitehouse Rhode Island, Charlie Condon South Carolina, Barnett Dakota, Cornyn Texas, William H. Sorrell Vermont, Christine O. Gregoire Washington, Darrell V. McGraw, Virginia, Anabelle Rodríguez Puerto Rico; AARP Sarah Lenz Lock, Vignery, Schuster, Robert Hayes; Council Senior Citizens Arn Pearson Bradley; National Legislatures Ruda James Crowley. Toubman Organizations Representing Beneficiaries curiae. From 1980 1989, increased 179% 134%. Between 1988, "increased rate 9.5 ..., component sector." Ford, Congressional Service Report Congress, Medicaid: Reimbursement Outpatient Prescription Drugs, CRS-15 (Mar. 7, 1991) (hereinafter Ford) 79 343, amended, 1396et seq. Centers Medicare & (CMS) groups include cash Aid Families Dependent Children (AFDC) aged, blind, disabled security income (SSI) benefits, low-income pregnant women children entitled poverty-related 1396a(a)(10)(A)(i) nonfinancial inclusion Medicaid, exceed categorically eligibility. 1396a(a)(10)(C). Individuals "entitled medically protection resources, deducting incurred expenses, falls[sic] below standards." House Subcommittee Environment Energy Commerce, Source Book: Background Data Analysis, 103d Cong., 1st Sess., 167 (Comm. Print 1993). CRS-1 "Before routinely costs.... enacting Section 1396r-8 intend upset practice." Brief Opposition asAmicus Curiae 14-15. 104 1388-143 availability essential beneficiaries, rating Food Administration, doctor obtained use. 1396r-8(a)(3) "A restrict biological Administration enactment section, period approval." 1388-150, 1927(d)(6) 107 613 paragraph (5) formulary paragraph." 1396r-8(d)(4) "labeler" person receives repackages later sale. 2681(2)(C) 317. "qualified residents," 2681(1) 2002), "who enrollment card," 2681(2)(F). provides: "It intention discourage employers offering paying employees replace employer-sponsored subchapter." respondents state: economically irrational Rx, mistakenly attempts so, [the] it." Respondents 268, 278 149. Seeid., 62-74. (Complaint ¶ 6). 50, 53, 76-77, 87. 57 (affidavit George Bilyk Janssen Pharmaceutica, Inc.). 112 Moules Corp.). 103-104. "Prior (`MCOs') enforce usually professionals. MCOs professionals MCO high severe life threatening side and/or interactions; (3) efficacy." 102-103. 149-150. 154. 167. 00-157-B-H (D. Me., Oct. 26, 2000), 68 observed: "If leverage easily put highway bridge construction school funding." note CMS, acting n. 3,supra, 2002, directors. letter, establishment secure rebates, discounts populations expect submit process." Amicus 48a. 9, ("A discount, give significantly decrease chance Medicaid-eligible"). estimated almost nonelderly come families 200% poverty level. Kaiser Commission Uninsured, Uninsured: Primer 2001) 23,supra. "As current option safeguard utilization efficiency, economy, care." H.R. Rep. 101-881, 98 (1990) "The Florida exempts `prior authorization' preferred list, call pharmacist course procedure, informs (usually list) value expensive. phone calls tend relatively minutes length), first-choice guaranteed 100 cases, she call. During approximately 55 resulted list. Naturally, profitable ones, favored pharmaceutical lawsuit." 1198 (internal quotation marks omitted) "There allocating free level amount devotes program."King Smith, 392 309, 318-319 (1968) (footnotes 30,supra. 54 I join I-III plurality's opinion. V's conclusion. entry posed "`[n]o modest,'" realizing goals. Ante, 659 (majority opinion) (emphasis added). plurality, believe italicized phrase understates strength make. 667. 56 prevail, ultimately "seriously compromise interests." Arkansas Elec. Cooperative Corp. Pub. Serv. Comm'n, 461 375, 389 (1983). Rosado Wyman, 397 397, 422-423 (1970). consequently "modest" benefit, 687-688 (O'CONNOR, part). language, all, permits programs, 1396r-8(d)(1), believed general, generating savings. ante, 651-653, opinion). forbid virtually per se i.e., slight recognize justified stronger E.g., 57, Amici 14. Yet nonetheless rests premises subsequent developments unrealistic. thing, initial argue matter, objectives, degree. 663-665 (plurality another, (whose highly infra page) somewhat prove 660-661, opinion); Letter Theodore K. Suter, Clerk (Jan. 10, 2003). result, now FERC, 495 490, 506 (finding "would disturb embodied [a] considered determination"). postentry considerations, along importance question, convince me overlook standard, affirm vacating 58 involve renewed so. (HHS) Institutionally speaking, (e.g., regarding caused patients) predictions furtherance goals). U.S.A. 837 (1984); Skidmore Swift Co., 323 134 (1944). 680-681 (THOMAS, judgment). 59 sets method views. file 1396. promptly reflect "[m]aterial changes organization, policy, program." CFR 430.12(c) said like "significant plan" expected amendment. 60 jurisdiction" Western 352 59, 63-65 (1956). fixed formula exists" doctrine's application. 64. Rather, instance raises "issues conventional experience judges," purview responsibilities; "limited functions judiciary rationally exercised, resort" "better equipped courts" instance; word, reference working relationship primary jurisdiction facilitate. 574-575 (1952); supra, 63-65. Pierce, Administrative Law 14.4, 944 (2002) (relatively frequent application cases). 61 Where little here Williams Pipe Line Empire Gas Corp., 76 F.3d 1491, 1496 (CA10 1996). Stein, Mitchell, Mezines, 47.01[1], pp. 47-5 47-6 (2002); Procedure: Lawyers Edition 2:337, 373 (2003). 64; Wagner Brown ANR Pipeline F.2d 199, 206 (CA5 1988) (stay duration). Lower sometimes preserve status quo. Wheelabrator Chafee, 455 1306, 1316 (CADC 1971). And, my consider, 672, issue, see, MacDonald Chicago Park District, 132 355, 357 (CA7 1997); 11A Wright, Miller, Kane, Practice Procedure 2948, 131-133 (1995). But Rosado, U.S., 406. 62 reasons, concur major 63 64 reject negative-Commerce-Clause neither facially nor (as explains, 668-670) hitherto grounds; because, elsewhere, Clause, foundation Constitution lending invalidation action, extended nondiscriminatory precise sort invalidated. 209-210 (1994) (opinion 65 agreed undertake Blessing Freestone, 329, 349 (SCALIA, concurring); Pennhurst School Hospital Halderman, 451 (1981), Services, 1396c. "arbitrary, accordance law." 66 67 plurality write separately "further result," 660, reasoning. preemption merit. Court. "stands (1941). agrees succeed "that Rx." 662. Both O'CONNOR embodying abstract generalized inconsistent depth. complex belies distill purpose. 69 cost, mandates flexibility, oversight discretion. principally relies 1396a(a)(19), "provide safeguards provided, recipients," pursues arguably control, 1396a(a)(30), affording Mfrs. Thompson, 259 2d 39, 72 (DC 2003) Research) (noting tension "`best interests'" recipients). 70 silent "severely curtai[l] drugs," 665, ignores complexity. Services' 71 begin Medicaid. Importantly, says drug." 1396r-8(d)(1)(A). placed enumerated Undoubtedly, "purpose" This reading confirmed near-neighbors. 1396r-8(d) allows (beyond authorization) "covered accepted indication," 1396r-8(d)(1)(B)(i), specified 1396r-8(d)(2). includes, "anorexia gain," 1396r-8(d)(2)(A), "cosmetic growth," 1396r-8(d)(2)(C), barbiturates, 1396r-8(d)(2)(I). Furthermore, 1396r-8(d)(6), limitations, class, minimum maximum quantities waste...." fine-tuning stands stark contrast confirm meant area explicitly. 73 uses, reason,1 illustrates futility discerning If, curtailed," 1396r-8(d)(2) empowers believes precisely opposed beneficiaries. illustration compromises demonstrates impossibility defining "purposes" statutes abstraction concomitant danger invoking arbitrary selection others. 74 dissent fail (and many) makes determining interests" contemplated curtai[l]" touchstone "conflict" 665). Otherwise rendered leaves internal conflict. reasons "safeguar[d] utilization," 685 part) omitted), explains ends.2 points nothing suggests associated merely asserts follows ipse dixit Post, 688-689 turns frustrated dissent's focus subjective intent legislature targeted asks irrelevant B implications delegated type pre-emptive approve 1396a, 1396a(b), withhold deems noncompliant, 1396c.3 acknowledging "may effective," potentially approval, discuss logical consequences 77 According forbidden necessarily, correct, reviewing step inquiry 842-843 (1984), unambiguous.4 Smiley Citibank (South Dakota), N. A., 517 735, 739 (1996). "has issue." Chevron, foregoing discussion unambiguously prohibit indicate "does prices, including purchases." Dir. Center Operations, Dirs. (Sept. 48a.5 preemption's "directly spoken" 78 offer, petitioner's, reach numerous 1396a(a), Among these, discussed [Medicaid] recipients." 1396a(a)(19). maintain examine plan, isolation. conduct, greater expertise courts, upsets Congress' delegation perform task precludes federal-court intervention bar performing duty adjudge contemplates necessary. decision, done approved. 69-72 C reached speculation advances "Medicaid-related goals" much disagreement aptly freewheeling undercut[s] principle Gade Solid Wastes Management Assn., 88, 111 (KENNEDY, D 80 Spending "is contract." (1981). contract analogy serious sue otherwise. 349-350 concurring). here) breach "intended beneficiary" contract. Restatement (Second) Contracts (1979) promise creates promisor beneficiary promise, duty"). When wishes intent. precedents, employ 1983 implied "unambiguously conferred right." Gonzaga Univ. 273, 283 satisfy bring lawsuit third-party advanced raised, enforced action. 81 Petitioner's met, "[t]he Constitution, sense, proved unworkable application." Camps Newfound/Owatonna, Town Harrison, 564, 610 dissenting). dissent) purpose-based they. value, care, judgments See,e.g., 1396r-8(d)(2)(B) (fertility drugs), 1396r-8(d)(2)(C) (cosmetic purposes). Again, begs why, growth requirements, Rx's head. pre-emption? find odd turn recited rationale indicates 1396a(a). 1396c reasonable notice opportunity supervising subchapter, finds "(1) changed longer section 1396a title; "(2) substantially provision; notify until comply." meaningfully interpreted laws, terms, laws concludes pose "purpose." 1396a(a)'s defunded congressional directive pre-empt I-D, infra. exists, deviate sanctions ambiguous ordinarily prevent pre-empted. rejection atChevron's step, reasonable. 843. upheld ColumbiaPharmaceutical court. whom CHIEF KENNEDY part. opinion, enjoining Before "point[ed] prior-authorization original). surprising. rich poor. purport population wholly related objectives" uphold basis, respectfully IV, Our analyzing scheme whole."Gade J.). look "`the whole object policy.'" (quoting Pilot Life Ins. Dedeaux, 481 41, (1987)). 96. exerted attained, character considering supreme enactments subject." 70. 1396r-8(d); 652. restriction. 1396r-8(d)(5) require, indication." definition, beneficiaries' "safeguard[ing] assur[ing] economy (1990). (1973) ("Where coordinate exist complementary framework, pursuit persuasive one" added)). not, generate revenue using accomplish inherent recognized, permit "highway funding," presumably took absurd "enabl[e] far practicable furnish dependent individuals, services." Consistent resource (IV), (VI), (VII); 1396b(f). reinforced afforded flexibility tailoring seeAlexander establishes prerequisites 1396a(a)(1)-(65). Two here. contain "safeguard utilization" "payments 1396a(a)(30)(A). initiatives stretching greatest Program's provision advancing "nonparticipating" dispensed 2681(7) need. 2681(1), (2)(F). erect concedes survive hold demonstrated bears out. State," accomplishes (2)(F), (7) justify An appellate confined reveals speculates [Maine Rx] successful." 663. "will `medically needy' [Aid Children] [Supplemental Income] benefits." "there reduced." posits "whenever participate," "[a]voi[d] 663, 664. Asserting "plainly Program," sua sponte constituted predicate" disagree. say met Cfante, 662-665. Each post-hoc justifications predicates record. predicate assumptions behind classified "borderline infirm" impossible discern reap populations. purchased out-of-pocket self-evident. advocating attenuated causal chain, hardly divining grounds. assertion necessarily unsupportable. imposition tied efficacy cost-effectiveness drug. sole trigger labeler would, worst delay inhibit medication. essentially rejects, hand, possibility. doing, distorts (1975) ("[W]hile district deciding plaintiff stringent, issuance discretion"). concrete On suggesting Finding circumstances, preliminarily requirement, reverse remand

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