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United States District Court, D. Columbia.
May 23, 2014
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA, Plaintiff,v.UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants
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Re Document Nos.: 3, 24, 25, 26 29, 32.
For Pharmaceutical Research And Manufacturers of America, Plaintiff: Jeffrey L. Handwerker, ARNOLD & PORTER LLP, Washington, DC USA.
For United States Department of Health And Human Services, Mary K Wakefield, in her official capacity as Administrator for the Health Resources and Services Administration, Health Resources And Services Administration, Kathleen Sebelius, in her official capacity as Secretary of Health and Human Services, Defendants: Jean-Michel Voltaire, LEAD ATTORNEY, U.S. DEPARTMENT OF JUSTICE, Washington, DC USA; Carol Federighi, U.S. DEPARTMENT OF JUSTICE, Civil Division, Federal Programs Branch, Washington, DC USA.
For Safety Net Hospitals For Pharmaceutical Access, National Rural Health Association, Americas Essential Hospitals, Movants: Barbara Straub Williams, LEAD ATTORNEY, POWERS, PYLES, SUTTER & VERVILLE, PC, Washington, DC USA; Ronald S. Connelly, LEAD ATTORNEY, POWERS, PYLES, SUTTER & VERVILLE, Washington, DC USA.
For American Hospital Association, Amicus: Diane M. Signoracci, LEAD ATTORNEY, BRICKER & ECKLER, LLP, Columbus, OH USA.
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Granting Plaintiff's Motion for an Injunction; Granting Plaintiff's Motion for Summary Judgment; and Disposing of All Other Pending Motions in This Case
RUDOLPH CONTRERAS, United States District Judge.
Orphan drugs are drugs that treat rare diseases or conditions, and are so-named because efforts to research, invest in, and produce them would otherwise be abandoned if not for the incentives Congress has provided pharmaceutical manufacturers to do so. While orphan drugs can only be designated as such to treat rare diseases or conditions, they can also be used to treat non-rare diseases or conditions.[1] For example, Prozac (generically named Fluoxetine) is designated an orphan drug for the treatment of autism and body dysmorphic disorder in children and adolescents, but is commonly prescribed for depression, a non-orphan condition. See Orphan Drug Designation and Approvals List as of March 3, 2014, at 72; [2] see also Amicus Curiae Brief of Safety Net Hospitals for Pharmaceutical Access, et al. 11, ECF No. 29-1 (" Safety Net Amicus Brief" ). Rituxan,[3] designated an orphan drug for treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis, non-Hodgkin's B-cell lymphoma, and immune thrombocytopenic purpura, is commonly prescribed to treat the non-orphan conditions of rheumatoid arthritis, multiple sclerosis, and autoimmune anemia. See Orphan Drug Designation and Approvals List as of March 3, 2014, at 254, see also Safety Net Amicus Brief at 9. The plaintiff in this case, Pharmaceutical Research and Manufacturers of America (" PhRMA" ), challenges a final rule promulgated by the Secretary (" Secretary" )
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of Health and Human Services (" HHS" ) addressing the uses for which an orphan drug must be offered at a discounted price, as specified in section 340B of the Public Health Service Act (" PHSA" ). Because the Court concludes that HHS lacks the statutory authority to engage in such rulemaking, the Court will vacate the final rule, and grant the plaintiff's motion for an injunction and motion for summary judgment.
A. The Orphan Drug Act
The Orphan Drug Act was passed in 1983 as an amendment to the Federal Food, Drug, and Cosmetic Act, " to facilitate the development of drugs for rare diseases and conditions . . . ." See Pub. L. 97-414, 96 Stat. 2049 (January 4, 1983). The Federal Food, Drug, and Cosmetic Act (" FFDCA" ) defines a " rare disease or condition" as " any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available . . . a drug for such disease or condition will be recovered from sales . . . of such drug." 21 U.S.C. § 360bb(a)(2).
Congress passed the Orphan Drug Act in part because it found that " because so few individuals are affected by any one rare disease or condition, a pharmaceutical company which develops an orphan drug may reasonably expect the drug to generate relatively small sales in comparison to the cost of developing the drug and consequently to incur a financial loss." 96 Stat. 2049 § 1(b)(4). To encourage the development of such drugs, the Orphan Drug Act provides the following incentives to pharmaceutical manufacturers of those drugs: (1) a seven-year market exclusivity period for the orphan drug (as opposed to a two-year period for regular drugs), see 21 U.S.C. § 360cc(a); (2) a clinical tax credit for any expenses incurred in developing an orphan drug, see 26 U.S.C. § 45C; (3) research grants for clinical testing, see 21 U.S.C. § 360ee, and (4) an exemption from new drug application fees, see 21 U.S.C. § 379h(a)(1)(F).
B. 340B Program
The 340B Program began in 1992 when Congress enacted it as part of the Veterans Health Care Act, codified as section 340B of the Public Health Service Act (" PHSA" ) at 42 U.S.C. § 256b. Section 340B of the PHSA " imposes ceilings on prices drug manufacturers may charge for medications sold to specified health care facilities." Astra USA, Inc. v. Santa Clara Cnty., Cal., 131 S.Ct. 1342, 1345, 179 L.Ed.2d 457 (2011). Under this program, manufacturers are required, as a condition to Medicaid covering their products, to enter into a pricing agreement with the Secretary of HHS. See 42 U.S.C. § 256b(a). Under those pricing agreements, certain covered entities, ( i.e., black lung clinics, hemophiliac diagnostic treatment centers, Native Hawaiian Health Centers, see 42 U.S.C. § § 256b(a)(4)(F)-(H)) can get pharmaceutical medications at a discounted price " if such drug is made available to any other purchaser at any price." Id. § 256b(a)(1).
Under the original 340B statute, covered entities were generally disproportionate share hospitals--hospitals that serve indigent populations. See id. § 256b(a)(4)(L). However, as part of the Patient Protection and Affordable Care Act (" ACA" ), Congress added several categories to the covered entities list that became (M), (N), and (O) under 42 U.S.C. § 256b(a)(4): children's hospitals excluded from the Medicare prospective payment system, free-standing
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cancer hospitals excluded from the Medicare prospective payment system, critical access hospitals, rural referral centers, and sole community hospitals. See Pub. L. 111-148 § 7101(a) (March 23, 2010), codified at 42 U.S.C. § 256b(a)(4)(M)-(O).
The Health Care and Education Reconciliation Act (" HCERA" ) also made several changes to the 340B Program, including excluding orphan drugs from 340B discount pricing available to the newly-added covered entities. This particular change is the critical statutory provision at issue in this case and goes as follows: " For covered entities described in subparagraph (M), (N), or (O) of subsection (a)(4), the term 'covered outpatient drug' shall not include a drug designated by the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or condition. " Pub. L. 111-152 § 2302(4), codified at 42 U.S.C. § 256b(e) (emphasis added). Thus, under the new orphan drug exclusion, the newly-added covered entities can get their pharmaceutical medications at a discounted price, except for orphan drugs, for which they must pay full price. But, as set forth below, the parties take opposing views as to whether these entities must pay full price for orphan drugs when used for a non-orphan indication.
C. Orphan Drug Exclusion Rule
In response to numerous letters from drug manufacturers and covered entities alike asking for clarification on the orphan drug exclusion promulgated under the ACA/HCERA, the Secretary of HHS published a notice of proposed rulemaking to " (1) provid[e] clarity in the marketplace, (2) maintain[] the 340B savings and interests to the newly-eligible covered entities; and (3) protect[] the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act as intended by Congress." See Notice of Proposed Rulemaking, Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program, 76 Fed. Reg. 29,183, 29,184 (May 20, 2011). HHS provided a 60-day comment period and received 50 comment letters raising a variety of issues from members of Congress, manufacturers, 340B entities and providers, and other 340B stakeholders. See Final Rule, Exclusion of Orphan Drugs for Certain Covered Entities under 340B Program, 78 Fed. Reg. 44,016, 44,017 (July 23, 2013). HHS then published the final rule on July 23, 2013. See id.
The Final Rule establishes, inter alia, that with respect to the newly-designated covered entities, " a covered outpatient drug does not include orphan drugs that are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which that orphan drug was designated under section 526 of the FFDCA. A covered outpatient drug includes drugs that are designated under section 526 of the FFDCA when they are transferred, prescribed, sold, or otherwise used for any medically-accepted indication other than treating the rare disease or condition for which the drug was designated under section 526 of the FFDCA." See 42 C.F.R. § 10.21(a) (emphasis added).
The practical effect of this rule is that the discounted 340B price is not available to newly-added covered entities when purchasing orphan drugs for their intended orphan use. When a covered entity purchases the orphan drug for a non-orphan use, however, it does receive the 340B discount price. For instance, as explained by amicus Safety Net Hospitals for Pharmaceutical Access, in the case of Prozac, " an affected hospital could purchase the drug at 340B discounts if it were used to treat depression, its common purpose, but
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an affected hospital would have to purchase the drug outside the 340B program [and therefore, not at a discounted rate] if it were used to treat either of its two orphan indications." See Safety Net Amicus Brief at 11.
The Final Rule also imposes duties on the covered entities to maintain records of compliance. Specifically, the rule states that " [a] covered entity listed in paragraph (b) of this section is responsible for ensuring that any orphan drugs purchased through the 340B Program are not transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drugs are designated under section 526 of the FFDCA. " 42 C.F.R. § 10.21(c)(1) (emphasis added). If the covered entity " cannot or does not wish to maintain auditable records sufficient to demonstrate compliance with this rule, [it] must notify HRSA [4] and purchase all orphan drugs outside of the 340B Program regardless of the indication for which the drug is used." Id. § 10.21(c)(3). The rule also explains that " [f]ailure to comply with this section shall be considered a violation of sections 340B(a)(5) and 340B(e) of the PHSA, as applicable." Id. § 10.21(f).
D. Preliminary Housekeeping issues
The plaintiff brought suit against HHS in this action, alleging that the rule contravenes the plain language of the statute, and is therefore invalid. Pending before the Court are the plaintiff's motion for a preliminary injunction and motion for summary judgment, see ECF Nos. 3 & 25, and the defendants' motion to dismiss, or in the alternative for summary judgment. See ECF No. 24. Also pending before the Court are: (1) the plaintiff's motion for judicial notice, see ECF No. 26, (2) an unopposed motion for leave to file an Amicus Curiae Brief by Safety Net Hospitals for Pharmaceutical Access (" Safety Net" ), see ECF No. 29, and (3) the plaintiff's motion to strike the extra-record material included in the amicus brief submission, see ECF No. 32.
The Court will address the latter three issues first, as they can be quickly disposed of. With respect to the plaintiff's motion for judicial notice, the plaintiff asks this Court to take judicial notice of the " Frequently Asked Questions" page related to orphan drug designation and development posted on the U.S. Food and Drug Administration's (" FDA" ) website. See ECF No. 26. Federal Rule of Evidence 201 provides that " [t]he court may judicially notice a fact that is not subject to reasonable dispute because it can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned." Fed. R. Ev. 201(b)(2). A court may also take judicial notice " at any stage of the proceeding." Fed. R. Ev. 201(d). Courts in this jurisdiction have frequently taken judicial notice of information posted on official public websites of government agencies. See Cannon v. District of Columbia, 717 F.3d 200, 205 n.2, 405 U.S. App.D.C. 141 (D.C. Cir. 2013) (taking judicial notice of document posted on the District of Columbia's Retirement Board website); Carik v. Dep't Health & Human Svcs., No. 12-272(BAH), 4 F.Supp.3d 41, 2013 WL 6189313, *4 n.4 (D.D.C. Nov. 27, 2013) (taking judicial notice of information on the FDA's website); Hyson v. Architect of Capitol, 802 F.Supp.2d 84, 90-91 n. 4 (D.D.C. 2011) (taking judicial notice of description on U.S. Office of Personnel Management's website). As such, this Court will grant the plaintiff's motion and take judicial notice of the Frequently Asked
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Questions page for " Developing Products for Rare Diseases and Conditions." [5]
The Court will also grant Safety Net's unopposed motion for leave to file an Amicus Curiae Brief. See ECF No. 29. The Court notes that in resolving the motions for summary judgment pending in this case, it has considered Safety Net's Amicus Curiae brief.[6]
A. Legal Standard: Motion to Dismiss & Summary Judgment
The plaintiff originally filed a motion for a preliminary injunction in this case, asking this Court to enjoin HHS from implementing the final rule scheduled to take effect October 1, 2013. See ECF No. 3. However, the parties jointly requested that the Court grant a motion to consolidate the hearing on the merits of this action with the hearing on the plaintiff's application for a preliminary injunction under Federal Rule of Civil Procedure 65(a)(2). See ECF No. 16. The Court granted that motion on October 25, 2013. See ECF No. 17. Because the Court decides that on the merits of the case, the plaintiff is entitled to a permanent injunction, it need not decide the preliminary injunction.
1. Motion to Dismiss
The Federal Rules of Civil Procedure require that a complaint contain " a short and plain statement of the claim" in order to give the defendant fair notice of the claim and the grounds upon which it rests. Fed.R.Civ.P. 8(a)(2); accord Erickson v. Pardus, 551 U.S. 89, 93, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007) (per curiam). A motion to dismiss under Rule 12(b)(6) does not test a plaintiff's ultimate likelihood of success on the merits; rather, it tests whether a plaintiff has properly stated a claim. See Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974). A court considering such a motion presumes that the complaint's factual allegations are true and construes them liberally in the plaintiff's favor. See, e.g., United States v. Philip Morris, Inc., 116 F.Supp.2d 131, 135 (D.D.C. 2000).
Nevertheless, " [t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell A. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). This means that a plaintiff's factual allegations " must be
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enough to raise a right to relief above the speculative level, on the assumption that all the allegations in the complaint are true (even if doubtful in fact)." Bell A. Corp. v. Twombly, 550 U.S. 544, 555-56, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citations omitted) (parenthetical in original). " Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements," are therefore insufficient to withstand a motion to dismiss. Iqbal, 556 U.S. at 678. A court need not accept a plaintiff's legal conclusions as true, see id., nor must a court presume the veracity of the legal conclusions that are couched as factual allegations. See Twombly, 550 U.S. at 555.
2. Summary Judgment
Typically, a court may grant summary judgment when " the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). But when assessing a summary judgment motion in an APA case, " the district judge sits as an appellate tribunal." Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083, 348 U.S. App.D.C. 77 (D.C. Cir. 2001). In a case such as this, the " complaint, properly read, actually presents no factual allegations, but rather only arguments about the legal conclusion to be drawn about the agency action." Marshall Cnty. Health Care Auth. v. Shalala, 988 F.2d 1221, 1226, 300 U.S. App.D.C. 263 (D.C. Cir. 1993). " The entire case on review is a question of law, and only a question of law." Id. The district court's review " is based on the agency record and limited to determining whether the agency acted arbitrarily or capriciously[,]" Rempfer v. Sharfstein, 583 F.3d 860, 865, 388 U.S. App.D.C. 226 (D.C. Cir. 2009), or in violation of another standard set out in section 10(e) of the APA, see 5 U.S.C. § 706 (2012).
B. APA Standard of Review
Under the APA, a reviewing court " shall hold unlawful and set aside agency action, findings, and conclusions found to be in excess of statutory jurisdiction, authority, or limitations, or short of statutory right." 5 U.S.C. § 706(2)(C). " It is axiomatic that an administrative agency's power to promulgate legislative regulations is limited to the authority delegated by Congress." Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208, 109 S.Ct. 468, 102 L.Ed.2d 493 (1988); see also Atl. City Elec. Co. v. FERC., 295 F.3d 1, 8, 353 U.S. App.D.C. 1 (D.C. Cir. 2002) (" In the absence of statutory authorization for its act, an agency's action is plainly contrary to law and cannot stand." ) (internal quotation marks and citations omitted). " To determine whether the agency's action is contrary to law, we look first to determine whether Congress has delegated to the agency the legal authority to take the action that is under dispute." Michigan v. EPA, 268 F.3d 1075, 1081, 348 U.S. App.D.C. 6, 348 U.S. App.D.C. 7 (D.C. Cir. 2001); see also id. at 1082 (" Agency authority may not be lightly presumed." ).
Judicial review of an agency's interpretation of its guiding statute usually follows a two-step process. The familiar Chevron two-step goes as follows: " First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress." Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-43, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). However, if " Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation."
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Id. at 843 (footnote omitted). In this latter situation, a court instead proceeds to step two of the Chevron framework: " [I]f the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute." Id. At this stage of the analysis, " a court may not substitute its own construction of a statutory provision for a reasonable interpretation made by the administrator of an agency." Id. at 844.
In United States v. Mead, the Supreme Court elaborated on when Chevron deference applies, holding that " administrative implementation of a particular statutory provision qualifies for Chevron deference when it appears that Congress delegated authority to the agency generally to make rules carrying the force of law, and that the agency interpretation claiming deference was promulgated in the exercise of that authority. " 533 U.S. 218, 226-227, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001) (emphasis added). Scholars coined this inquiry " Chevron Step Zero--" a threshold question as to whether Chevron deference even applies at all. See generally Cass R. Sunstein, Chevron Step Zero, 92 Va. L. Rev. 187 (2006). The question of whether Chevron applied to an agency's interpretation of the scope of its regulatory authority--its jurisdiction--was left unanswered by the Supreme Court. Or, to the extent that question was answered, it resulted in confusion in the lower courts about what the standard of review should be. See id. at 234-236.
Last year, however, the Supreme Court clarified the standard of review that governs " an agency's interpretation of a statutory ambiguity that concerns the scope of its regulatory authority (that is, its jurisdiction) . . . ." City of Arlington, Tex. v. F.C.C., 133 S.Ct. 1863, 1866, 185 L.Ed.2d 941 (2013) (parenthetical in original). The Court explained that whatever the inquiry, Chevron deference applies: " the distinction between 'jurisdictional' and 'nonjurisdictional' interpretations is a mirage. No matter how it is framed, the question a court faces when confronted with an agency's interpretation of a statute it administers is always, simply, whether the agency has stayed within the bounds of its statutory authority. " Id. at 1868 (emphasis in original). It went on to explain:
[J]udges should not waste their time in the mental acrobatics needed to decide whether an agency's interpretation of a statutory provision is 'jurisdictional' or 'nonjurisdictional.' Once those labels are sheared away, it becomes clear that the question in every case is, simply, whether the statutory text forecloses the agency's assertion of authority, or not.
Id. at 1870-71; accord Verizon v. FCC, 740 F.3d 623, 635, 408 U.S. App.D.C. 92 (D.C. Cir. 2014) (" As the Supreme Court has recently made clear, Chevron deference is warranted even if the Commission has interpreted a statutory provision that could be said to delineate the scope of the agency's jurisdiction." ) (citing City of Arlington, 133 S.Ct. at 1874).
However, not all agency interpretations are accorded Chevron deference. Where an agency's interpretation lacks the force of law, it is " beyond the Chevron pale." Mead, 533 U.S. at 234; accord Christensen v. Harris Cnty., 529 U.S. 576, 587, 120 S.Ct. 1655, 146 L.Ed.2d 621 (2000). Instead, courts may afford some deference to a non-binding agency interpretation of its guiding statute to the extent the interpretation has the " power to persuade." See Skidmore v. Swift & Co., 323 U.S. 134, 140, 65 S.Ct. 161, 89 L.Ed. 124 (1944) (" We consider that the rulings, interpretations and opinions
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of the Administrator under this Act, while not controlling upon the courts by reason of their authority, do constitute a body of experience and informed judgment to which courts and litigants may properly resort for guidance." ). " [I]nterpretive rules . . . enjoy no Chevron status as a class." Mead, 533 U.S. at 232; see also Bamonte v. City of Mesa, 598 F.3d 1217, 1228 (9th Cir. 2010) (explaining that " Chevron deference is reserved for legislative rules that an agency issues within the ambit of the authority entrusted to it by Congress," whereas an agency rule or decision " not within an area of express delegation of authority or [that] does not purport to have the force of law" is entitled to Skidmore deference).[7]
C. HHS's rulemaking authority under the PHSA
The plaintiff's first argument, and ultimately the dispositive one in this case, is that HHS lacks statutory rulemaking authority to promulgate the orphan drug rule at issue here. See Pl.'s Mot. Summ. J. 13-18, ECF No. 25-1. As articulated above, " the question a court faces when confronted with an agency's interpretation of a statute it administers is always, simply, whether the agency has stayed within the bounds of its statutory authority. " City of Arlington, 133 S.Ct. at 1868 (emphasis in original); see id. at 1874 (" for Chevron deference to apply, the agency must have received congressional authority to determine the particular matter at issue in the particular manner adopted." ); see also Adams Fruit Co., Inc. v. Barrett, 494 U.S. 638, 649-50, 110 S.Ct. 1384, 108 L.Ed.2d 585 (1990) (" A precondition to deference under Chevron is a congressional delegation of administrative authority." ) (citation omitted).
The plaintiff argues that HHS lacks the statutory authority to implement 340B(e) rulemaking, relying largely on Gonzales v. Oregon, 546 U.S. 243, 126 S.Ct. 904, 163 L.Ed.2d 748 (2006). Gonzales involved a challenge to an Interpretive Rule implemented by the Attorney General under the Controlled Substances Act (" CSA" ), which he issued in response to Oregon passing the " Death with Dignity Act," which exempted from civil or criminal liability state-licensed physicians who prescribed a lethal dose of drugs upon request of a terminally ill patient. See id. at 249. Congress had given the Attorney General rulemaking power to fulfill his or her duties in two specific areas: (1) " to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals [under 21 U.S.C. § 821]" and (2) " [to] promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter." Id. at 259. Congress did not delegate authority to the Attorney General " to carry out or effect all provisions of the CSA." Id. Invoking those two specific
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provisions for rulemaking authority, the Attorney General implemented an Interpretive Rule concerning physician assisted suicide explaining that " [a]ssisting suicide is not a legitimate medical purpose within the meaning of 21 CFR 1306.04 (2001), and [] prescribing, dispensing, or administering federally controlled substances to assist suicide violates the Controlled Substances Act." Id. at 254. The Supreme Court found that the Attorney General's rule exceeded his statutory rulemaking authority because, inter alia, " [t]he CSA does not grant the Attorney General this broad authority to promulgate rules." Id. at 259. The Court elaborated that the two specific grants of rulemaking authority could not be stretched to include such broad, expansive rulemaking authority. Id. at 267 (" The idea that Congress gave the Attorney General such broad and unusual authority through an implicit delegation in the CSA's registration provision is not sustainable." ). The Court went on to find that even under the Skidmore standard of deference,[8] the Attorney General's position did not pass muster. Id. at 268-69.
The D.C. Circuit has similarly taken the position that " [w]here Congress prescribes the form in which an agency may exercise its authority . . . [the court] cannot elevate the goals of an agency's action, however reasonable, over that prescribed form." Amalgamated Transit Union v. Skinner, 894 F.2d 1362, 1364, 282 U.S. App.D.C. 322 (D.C. Cir. 1990). In Amalgamated Transit Union, the Urban Mass. Transportation Administration (" UMTA" ) " issued regulations to require recipients of federal mass transit funds to implement an anti-drug program for [federal] employees who perform sensitive safety functions." Id. at 1363. In promulgating the rule, UMTA relied on § 22 of the Urban Mass. Transportation Act which authorized the Secretary of Transportation to " investigate conditions in any facility, equipment, or manner of operation financed under this chapter which the Secretary believes creates a serious hazard of death or injury. " Id. at 1365 (emphasis added). If the Secretary determines that such conditions create a hazard, " he shall require the local public body which has received funds . . . to submit a plan for correcting or eliminating such condition" and may even withhold funding from that local public body. Id. " Based on the premise that the use of any controlled substance has the potential to degrade safety performance, UMTA proposed regulations that would detect and deter drug use among mass transportation workers performing sensitive-safety functions." Id. The court found that the language of § 22 " does not . . . confer authority upon UMTA to define initially through rulemaking the precise terms of that [local] plan and condition receipt of federal money on compliance with those specific terms, prior to any dialogue with local agencies (and their unions) that must begin by the submission of a locally-developed plan." Id. at 1369 (parenthetical in original). Importantly, the court noted, Congress had given UMTA specifically delegated authority " to investigate safety hazards . . . in a manner that requires case-by-case development of local solutions to those hazards." Id. (emphasis added). Accordingly, UMTA's " prophylactic rulemaking," see id. at 1368, was unauthorized agency action, and the court reversed and remanded the case to the
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district court to vacate the anti-drug program rule. Id. at 1372.
The D.C. Circuit did the same in Motion Picture Ass'n of America v. FCC, 309 F.3d 796, 353 U.S. App.D.C. 405 (D.C. Cir. 2002). That case involved Congress's enactment of the Telecommunications Act of 1996, which amended the Communications Act, and the provision that specifically dealt with closed captioning and video description technologies employed to enhance television watching for hearing and visually impaired individuals. Id. at 798. The Telecommunications Act required the FCC to " complete a closed captioning inquiry and to report its findings to Congress," and " to prescribe closed captioning regulations and establish[] compliance deadlines." Id. With respect to video descriptions, however, Congress only " required the FCC to prepare a report to Congress." Id. The FCC nevertheless implemented rules mandating television programming with video descriptions, and the court vacated the rules because " the FCC can point to no statutory provision that gives the agency authority to mandate visual description rules." Id. at 807; see also Am. Library Ass'n v. FCC, 406 F.3d 689, 708, 365 U.S. App.D.C. 353 (D.C. Cir. 2005) (" categorically" rejecting the FCC's argument that " it possesses plenary authority to act within a given area simply because Congress has endowed it with some authority to act in that area" ) (emphasis in original); Cal. Indep. Sys. Op. Corp. v. FERC, 372 F.3d 395, 396, 401, 362 U.S. App.D.C. 28 (D.C. Cir. 2004) (vacating a FERC order replacing the governing board of a public benefit corporation because " Congress's specific and limited enumeration of FERC's power over corporate governance in section 305 [of the Federal Power Act] is strong evidence that section 206(a) confers no such authority on FERC" to resolve conflicts of interest among the directors of public utilities by altering the corporate governance structure of public utilities.); United Mine Workers of America v. Mine Safety & Health Admin., 823 F.2d 608, 617-19, 262 U.S. App.D.C. 200 (D.C. Cir. 1987) (invalidating a regulation implemented by the Secretary of Labor regarding interim relief for mining companies because there was no statutory grant of authority for the Secretary to do so, and there was strong evidence that " Congress did not intend to authorize the Secretary to grant temporary relief from mandatory health and safety standards as a matter of course under section 101(c)" ); cf. Sutton v. United Air lines, Inc., 527 U.S. 471, 479, 119 S.Ct. 2139, 144 L.Ed.2d 450 (1999), overturned due to legislative action by Pub. L. 110-325 (2009) (finding that various agencies' interpretations of the word " disability" under the ADA did not deserve deference for various reasons, including that " no agency has been delegated authority to interpret the term 'disability.'" ).
In promulgating the final rule at issue here, HHS relied upon five statutory authorizations of rulemaking authority. Specifically, HHS relied upon: (1) Section 340B of the PHSA, 42 U.S.C. § 256b, as amended, (2) Section 215 of the PHSA, 42 U.S.C. § 216, as amended, (3) Section 526 of the FFDCA, 21 U.S.C. § 360bb, as amended, (4) Section 701(a) of the FFDCA, 21 U.S.C. § 371(a); and (5) Section 1927 of the Social Security Act, 42 U.S.C. § 1396r-8, as amended. See 78 Fed. Reg. at 44,027. Ultimately, the Court finds that the statutory provisions HHS has strung together to give it rulemaking authority are much like the provisions in Gonzales and Amalgamated Transit Union, in that they are specific grants of authority that do not authorize the orphan drug rule implemented here. As such, the Court " must give effect to the unambiguously expressed intent of Congress," and vacate the final rule under Chevron step
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one. See City of Arlington, 133 S.Ct. at 1868.
1. Non-section 340B rulemaking authority
The last four statutory provisions relied upon by HHS clearly do not confer any rulemaking authority upon HHS for the orphan drug rule issued here, because they do not arise under the PHSA or the 340B program. As such, HHS has acted beyond " the bounds of its statutory authority," see id., and is not entitled to Chevron deference. 42 U.S.C. § 216(b) gives the Surgeon General, with the approval of the Secretary, authority to " promulgate all other regulations necessary to the administration of the [Public Health] Service, including regulations with respect to uniforms for employees, and regulations with respect to the custody, use, and preservation of the records, papers, and property of the Service." While such a section does confer general rulemaking authority on the Secretary, the statute is clear that the regulations she may issue pursuant to that grant must pertain to the " administration of the [Public Health] Service," [9] not the implementation of the Public Health Service Act. Though the Health Resources and Services Administration (" HRSA" ) is considered a component of the U.S. Public Health Service,[10] the rulemaking authority clearly applies to administrative issues such as regulations regarding uniforms, record-keeping, etc.--not implementation of any and all statutes related to the public health. That statutory provision thus cannot be read to grant the Secretary the authority to issue the orphan drug rule at issue here.
The second rulemaking provision upon which HHS relies also does not confer rulemaking authority on the Secretary to issue the rule under the 340B Program. 21 U.S.C. § 360bb(d) provides that " [t]he Secretary shall by regulation promulgate procedures for the implementation of subsection (a) of this section." Subsection (a), meanwhile, provides for orphan drug designation by the Secretary, specifying that " [t]he manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition." 21 U.S.C. § 360bb(a). The procedures for implementation therefore, clearly refer to the process for orphan drug designation in the first instance--which is handled by the FDA--not the HRSA under the 340B Program.[11] Importantly, Title 21 of the United States Code pertains to the FFDCA; the 340B Program, meanwhile is part of Title 42 and the PHSA--an entirely different statute. A limited grant of rulemaking authority in an entirely different statute, therefore, cannot carry the day for the rulemaking here. Cf. Sutton, 527 U.S. at 478-79 (explaining that the EEOC's authority to issue regulations under Title I of the ADA did not give it the authority to then interpret the term " disability," which fell outside Title I of the ADA); Kelley v. EPA, 15 F.3d 1100, 1105, 304 U.S. App.D.C. 369 (D.C. Cir. 1994)
Page 41
(explaining that " [a]lthough the mandate of section 105 [of CERCLA] does provide the EPA with broad rulemaking authority . . . it is hardly a specific delegation of authority to EPA to interpret section 107." ) (internal citation omitted).
HHS also relies on another provision within Title 21 (again, the FFDCA), 21 U.S.C. § 371(a), which states that " [t]he authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary." The chapter referred to is Chapter 9 of the Federal Food, Drug, and Cosmetic Act. The rule issued here is found in Chapter 6 of the Public Health Service Act--again, an entirely different statute altogether.
Finally, HHS also relies upon 42 U.S.C. § 1396r-8, which pertains to Medicaid payment for covered outpatient drugs, and authorizes the Secretary to " by regulation, periodically update the list of drugs or classes of drugs described in paragraph (2) or their medical uses, which the Secretary has determined, based on data collected by surveillance and utilization review programs of State medical assistance programs, to be subject to clinical abuse or inappropriate use." 42 U.S.C. § 1396r-8(d)(3) (emphasis added). Paragraph (2), meanwhile, lists the drugs that may be excluded from Medicaid coverage, or otherwise restricted, such as drugs used for anorexia, weight loss, or weight gain, drugs used to promote fertility, and several other categories of which orphan drugs are not a part. 42 U.S.C. § 1396r-8(d)(2).[12] Again, this limited, specific, grant of rulemaking authority does not confer upon HHS authority to issue the rule here, which arises under section 340B of the PHSA.[13]
2. Section 340B rulemaking authority
The provisions within section 340B of the PHSA upon which HHS rely for its authority require more analysis. Within section 340B, Congress specifically authorized rulemaking in three places: (1) the establishment of an administrative dispute resolution process, (2) the " regulatory issuance" of precisely defined standards of methodology for calculation of ceiling prices, and (3) the imposition of monetary civil sanctions. The Court analyzes each in turn.
HHS first relied on the following provision regarding the establishment of an administrative dispute resolution process in promulgating the final rule here:
the Secretary shall promulgate regulations to establish and implement an administrative process for the resolution of claims by covered entities that they have been overcharged for drugs purchased under this section, and claims by manufacturers . . . of violations of subsections (a)(5)(A) or (a)(5)(B) . . . .
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42 U.S.C. § 256b(d)(3)(A) (emphasis added).
HHS argues that it " promulgated the present regulation to clarify the law in advance instead of waiting for an adjudicatory proceeding," and " [b]ecause of the confusion in the marketplace, the agency's jurisdiction to adjudicate would necessitate its deciding--at least in adjudications--to what drugs the exception applies." Fed.-Def.'s Mot. Summ. J. 16, ECF No. 24-1. HHS relies on National Petroleum Refiners Association v. FTC for the proposition that " courts are recognizing that use of rule-making to make innovations in agency policy may actually be fairer to regulated parties than total reliance on case-by-case adjudication." 482 F.2d 672, 681, 157 U.S. App.D.C. 83 (D.C. Cir. 1973). While that court recognized rulemaking as preferable to " adjudication for development of new agency policy," see id. at 683, it did so in the context of a statute that conferred broad rulemaking authority on the agency to carry out its adjudicatory and other functions. For instance, section 5(b) of the Trade Commission Act (which established the Federal Trade Commission) directed the Commission to accomplish its statutory goal of preventing unfair methods of competition " by means of issuance of a complaint, a hearing, findings as to the facts, and issuance of a cease and desist order." Id. at 675. Meanwhile, section 6(g) of the Trade Commission Act empowered the Commission to " make rules and regulations for the purpose of carrying out the provisions of [ inter alia], Section 5 [of the Act]." Id. at 676-77, 676 n.7. The court therefore found that " under the terms of its governing statute and under section 6(g) . . . in particular, the Federal Trade Commission is authorized to promulgate rules defining the meaning of the statutory standards of the illegality the Commission is empowered to prevent." Id. at 698 (citations omitted) (emphasis added).
Unfortunately for HHS, the Court's holding in National Petroleum turned on the fact that the FTC had a grant of broad rulemaking authority " to carry out" the provisions of its adjudicatory power, as well as broad rulemaking authority in its governing statute, that are absent here. Here, Congress has given HHS rulemaking power specifically for purposes of administering a dispute resolution process " for the resolution of claims by covered entities that they have been overcharged for drugs purchased under this section, and claims by manufacturers . . . of violations of [the prohibition on duplicate discounts and/or resales] . . . ." 42 U.S.C. § 256b(d)(3)(A). Congress has specifically delineated the scope of HHS's rulemaking authority in that regard to: (1) designating or establishing a decision-making official or decision-making body within the HHS for reviewing and resolving claims by covered entities that they have been overcharged; see id. § 256b(d)(3)(B)(i); (2) establishing deadlines and procedures to make sure claims are resolved fairly, see id. § 256b(d)(3)(B)(ii); (3) establishing discovery procedures for covered entities, see id. § 256b(d)(3)(B)(iii); (4) requiring manufacturers to conduct audits, see id. § 256b(d)(3)(B)(iv); (5) allowing consolidation of claims by more than one manufacturer against the same covered entity, see id. § 256b(d)(3)(B)(v); and (6) allowing joint claims by multiple covered entities against the same manufacturer, see id. § 256b(d)(3)(B)(vi). The rulemaking authority granted HHS by Congress under the 340B program has thus been specifically limited, and HHS has not been granted broad rulemaking authority to carry out all the provisions of the 340B program. Instead, Congress has limited HHS's rulemaking authority to creating a system for resolving disputes between covered entities and manufacturers--not to engaging
Page 43
in prophylactic non-adjudicatory rulemaking regarding the 340B program altogether. While the Court agrees that a prophylactic rule like this seems like the most reasonable way for implementing the orphan drug exclusion, unfortunately, Congress did not delegate to HHS broad rulemaking authority as a means of doing so.[14]
Tied into the regulations HHS is allowed to promulgate for the administrative dispute resolution process is the following language regarding improvements in 340B program integrity, codified at 42 U.S.C. § 256b(d), and referenced in the grant of specific rulemaking authority: " the Secretary shall promulgate regulations to establish and implement an administrative process . . . including appropriate procedures for the provision of remedies and enforcement of determinations made pursuant to such process through mechanisms and sanctions described in paragraphs (1)(B) and (2)(B)" . See id. § 256b(d)(3)(A). Paragraphs (1)(B) and (2)(B), meanwhile, discuss improvements in compliance by manufacturers and covered entities, respectively. With respect to manufacturer compliance, those sections call on the Secretary to " provide for improvements in compliance" by, inter alia, " [t]he development of a system to enable the Secretary to verify the accuracy of ceiling prices," including " [d]eveloping and publishing through an appropriate policy or regulatory issuance, precisely defined standards and methodology for calculation of ceiling prices under [subsection (a)(1)]." Id. § 256b(d)(1)(B)(i)(I) (emphasis added). The Secretary is also tasked with, inter alia, " [p]erforming spot checks of sales transactions," " [c]omparing regularly the ceiling prices calculated by the Secretary with the quarterly pricing data," and " [e]stablish[ing] procedures for . . . issu[ing] refunds." See id. § 256b(d)(1)(B)(i)-(ii). With respect to covered entity compliance, the Secretary is authorized to provide for improvements such as " [t]he development of more detailed guidance describing methodologies and options available to covered entities for billing covered outpatient drugs," and " [t]he establishment of a single, universal, and standardized identification system by which each covered entity site can be identified by manufacturers . . . for purposes of facilitating the ordering . . . ." Id. § 256b(d)(2)(B)(iii)-(iv). Finally, the Secretary is also authorized to establish regulations for imposing civil monetary sanctions. See id. § 256b(d)(1)(B)(vi)(I) (" The imposition of sanctions in the form of civil monetary penalties . . . shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after March 23, 2010." ).
Of all of those compliance improvements delineated above, only two mention the Secretary's ability to issue regulations. One section authorizes the Secretary to develop " through an appropriate policy or regulatory issuance, precisely defined standards and methodology for the calculation of ceiling prices" under subsection (a)(1). See id. § 256b(d)(1)(B)(i)(I) (emphasis added). The government argues that " [i]n order for HHS to define these standards precisely, HHS must define
Page 44
which drugs are 'covered outpatient drugs' for purposes of the 340B Program," citing Krista Pedley's declaration as authority. See Def.'s Opp'n Mot. 18, ECF No. 24-1. However, that does not follow from the text of the statute. The discount price offered to a covered entity--the ceiling price--is set by determining the average manufacturer price (" AMP" ), which is then reduced by the rebate percentage described in 42 U.S.C. § 1396r-8(c).[15] See 42 U.S.C. § 256b(a)(1). 42 U.S.C. § 256b(a)(1) specifies that the Secretary shall require " that the manufacturer offer each covered entity covered outpatient drugs at or below the applicable ceiling price if such drug is made available to any other purchaser at any price." Thus, the only relevance the ceiling price has to the definition of " covered outpatient drugs" is that a covered entity either will get the discount or it will not. Whether the covered outpatient drug gets a discount at all, in other words, is an entirely separate process from the complex calculation involved in determining the ceiling price and the average manufacturer price in the first instance. See Astra, 131 S.Ct. at 1345-46 (explaining that the ceiling price calculation is derived from the average and best prices and rebates calculated under the Medicaid Drug Rebate Program and that " [c]alculation of a manufacturer's 'average' and 'best' prices, undertaken by the pharmaceutical company, is a complex enterprise requiring recourse to detailed information about the company's sales and pricing." ) (citing 42 U.S.C. § 1396r-8(c) & (k)).
Specifically, the Social Security Act defines average manufacturer price as follows: " [subject to certain exclusions], the term 'average manufacturer price' means, with respect to a covered outpatient drug of a manufacturer for a rebate period, the average price paid to the manufacturer for the drug in the United States by (i) wholesalers for drugs distributed to retail community pharmacies; and (ii) retail community pharmacies that purchase drugs directly from the manufacturer." 42 U.S.C. § 1396r-8(k)(1)(A). The statute goes on to list what discounts and payments are excluded from the calculation of the average manufacturer price. See id. § § 1396r-8(k)(1)(B)(i)-(ii) (excluding, for example, customary prompt pay discounts extended to wholesalers, bona fide service fees paid by manufacturers to wholesalers, and certain reimbursements). Moreover, HHS guidance documents enacted as part of the 340B Program explain how the drug price of a covered outpatient drug is calculated:
To determine the price for a covered outpatient drug, the manufacturer shall calculate the average manufacturer price (AMP) for the drug and reduce it by the rebate percentage. Average manufacturer price is the average price paid to the manufacturer for the drug in the United States by wholesalers for the drug distributed to the retail pharmacy class of trade in the calendar quarter . . . . The Medicaid rebate calculation utilizes the Best Price information which considers the lowest price available at which the manufacturer sells the covered outpatient drug to any wholesaler, retailer, nonprofit entity, or governmental entity . . . .
See Guidance Regarding Section 602 of the Veterans Health Care Act of 1992; Limitation on Prices of Drugs Purchased by Covered Entities, 58 Fed. Reg. 27,289, 27,291 (May 7, 1993). Meanwhile, as to the " best
Page 45
price" figure, the text of the Social Security Act reveals that whether a discount is applied to a covered entity is irrelevant to the " best price," and in turn, the ceiling price calculation. See 42 U.S.C. § 1396r-8(c)(1)(C)(i)(I) ( " The term 'best price' means . . . the lowest price available from the manufacturer during the rebate period to any wholesaler, retailer, provider . . . excluding any prices charged . . . to . . . a covered entity described in subsection (a)(5)(B) of this section. . . ." ). The text of all the statutory provisions that determine ceiling price thus show that the classification of a drug as a " covered outpatient drug" is not part of the equation for ceiling price determination. Thus, a drug's classification is not required, " in order for [HHS] to define these standards [for calculating ceiling price] precisely." Pedley Decl. ¶ 16, ECF No. 24-3.[16]
Finally, the specific delineation for regulation regarding civil monetary sanctions also cannot be interpreted to allow for the expansive rule at issue in this case. This specific grant of rulemaking authority is not enough to sustain rulemaking for an entirely different purpose under the statute. See Gonzales, 546 U.S. at 267; Amalgamated Transit Union, 894 F.2d at 1369.
Under Chevron step one, then, all of the foregoing statutory provisions are clear that they do not confer orphan drug rulemaking authority upon the agency. In other words, the agency did not receive congressional authority " to determine the particular matter at issue in the particular manner adopted." City of Arlington, 133 S.Ct. at 1874. Rather, Congress gave HHS a specific delegation of rulemaking authority to establish an adjudication procedure to resolve disputes between covered entities and manufacturers. Though the Court finds the agency's proactive, prophylactic rule to be the most reasonable way of administering the statute, Congress has not given HHS the broad rulemaking authority to do so, and " [w]here Congress has established a clear line, the agency cannot go beyond it . . . ." Id. As such, the Court must vacate the final rule, and grant the plaintiff's motions.
D. Interpretive Rule Theory
In the alternative, HHS asks this Court to uphold the rule as an interpretive, as opposed to a legislative, rule. See Def.'s Opp'n Mot. 21, ECF No. 24-1. HHS relegates one paragraph of its opposition brief to this issue; however, such relief poses a much more nuanced and complicated question than suggested by the parties. As the D.C. Circuit has explained, there are many different formulations for determining whether a rule is legislative as opposed to interpretive. See Community Nutrition Institute v. Young, 818 F.2d 943, 946, 260 U.S. App.D.C. 294 (D.C. Cir. 1987) (" The distinction between legislative rules and interpretive rules or policy statements has been described at various times as 'tenuous,' 'fuzzy,' 'blurred,' and perhaps most picturesquely,
Page 46
'enshrouded in considerable smog.'" ) (per curiam) (citations omitted). Nevertheless, the D.C. Circuit has formulated a well-known four-factor test for determining whether a rule is legislative, and in turn, subject to Chevron deference. Am. Min. Cong. v. Mine Safety & Health Admin., 995 F.2d 1106, 302 U.S. App.D.C. 38 (D.C. Cir. 1993). In American Mining Congress, the Court stated the test as follows:
Accordingly, insofar as our cases can be reconciled at all, we think it almost exclusively on the basis of whether the purported interpretive rule has " legal effect," which in turn is best ascertained by asking (1) whether in the absence of the rule there would not be an adequate legislative basis for enforcement action or other agency action to confer benefits or ensure the performance of duties, (2) whether the agency has published the rule in the Code of Federal Regulations, (3) whether the agency has explicitly invoked its general legislative authority, or (4) whether the rule effectively amends a prior legislative rule. If the answer to any of these questions is affirmative, we have a legislative, not an interpretive rule.
Id. at 1112.[17]
The government's argument is half-hearted, and the Court is inclined to think it is wrong because the rule (1) underwent notice and comment rulemaking--the hallmark of a legislative rule [18]--and (2) it has a " legal effect" on the parties so regulated because the interpretation of " covered outpatient drug," as well as the compliance procedures impose obligations on covered entities and manufacturers alike. See Elec. Privacy Info. Ctr. v. U.S. Dep't of Homeland Sec., 653 F.3d 1, 6-7, 397 U.S. App.D.C. 313 (D.C. Cir. 2011) ( " The practical question inherent in the distinction between legislative and interpretive regulations is whether the new rule effects a substantive regulatory change to the statutory or regulatory regime." ) (internal citation omitted); Gen. Motors Corp. v. Ruckelshaus, 742 F.2d 1561, 1565, 239 U.S. App.D.C. 408 (D.C. Cir. 1984) (" If by its action the agency intends to create new law, rights or duties, the rule is properly considered to be a legislative rule." ).
However, if HHS wishes to pursue the interpretive rule theory further, the Court needs more briefing on why the rule is interpretive, the implications of it being found interpretive, whether parts of the rule can be vacated and others upheld as interpretive, and whether it can be challenged now, or whether HHS must first promulgate the rule as interpretive for it
Page 47
to then be challenged under Skidmore. [19] On the issue before the Court today--whether HHS has substantive rulemaking authority under section 340B of the PHSA to promulgate the orphan drug rule--the Court concludes that HHS does not, and that the final rule must be vacated.
For the foregoing reasons, the plaintiff's motion for an injunction and motion for summary judgment are GRANTED, and the defendants' motion for summary judgment is DENIED. An order consistent with this Memorandum Opinion is separately and contemporaneously issued.
Granting Plaintiff's Motion for an Injunction; Granting Plaintiff's Motion for Summary Judgment; and Disposing of All Other Pending Motions in This Case
For the reasons stated in the Court's Memorandum Opinion separately issued today, plaintiff's motion for an injunction (ECF No. 3) and motion for summary judgment (ECF No. 25) are GRANTED; and defendants' motion to dismiss, or in the alternative for summary judgment (ECF No. 24) is DENIED WITHOUT PREJUDICE. It is hereby ORDERED that the final rule, 42 C.F.R. § 10.21 is VACATED. It is FURTHER ORDERED that
(1) plaintiff's motion for Judicial Notice (ECF No. 26) is GRANTED;
(2) Safety Net is GRANTED leave to file an Amicus Brief (ECF No. 29);
(3) plaintiff's motion to strike (ECF No. 32) is DENIED AS MOOT; and
(4) to the extent the defendants wish to file supplemental briefs on the interpretive rule issue, they shall do so no later than June 13, 2014. SO ORDERED.
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October 22, 2012
CHARLES BROWN, PETITIONER,v.JAMES D. HARTLEY,RESPONDENT.
Petitioner is a state prisoner proceeding pro se with a petition for a writ of habeas corpus pursuant to 28 U.S.C. § 2254. Following a 2007 jury trial and conviction for attempted murder, petitioner was sentenced to ten years in state prison. Petitioner alleges constitutional violations based on the alleged breach of an earlier plea agreement in which petitioner pled guilty to assault in exchange for a sentence of time served. From the record before the court, it appears that the trial court initially approved the plea, but withdrew it at the sentencing hearing in light of new information concerning petitioner's criminal history. See Cal. Penal Code § 1192.5. At petitioner's post-trial sentencing hearing before a different trial judge, petitioner raised this issue. The prosecutor confirmed that, in light of the new information, "the deal didn't go through" and the criminal case against petitioner was dismissed and re-filed with a different case number. 2 RT 565; see also 1 CT 18. This second case proceeded to trial, resulting in the conviction and sentence now challenged by petitioner.
In order to make findings related to the rejection and/or withdrawal of petitioner's original plea to assault, the court requires a record of these proceedings, which appear to have taken place on February 21, 2007 in the Sacramento County Superior Court, Case No. 06F05149. See 1 CT 21. Accordingly, the court will direct respondent to lodge any available records of that case, including a transcript of the sentencing hearing, within 30 days.
IT IS HEREBY ORDERED THAT respondent shall lodge any available records of Sacramento County Superior Court Case No. 06F05149, including a transcript of the February 21, 2007 sentencing hearing, or show good cause why he is unable to do so, within 30 days of this order.
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In the movie Hellboy, a demon is raised by a scientist to be a member of the Bureau of Paranormal Research and Defense, which is charged with the defense of the US public against supernatural menaces. The forces of evil kidnap him, his girlfriend, and another agent after killing the scientist who fathered him. The evildoers then torture his girlfriend until he takes up the mantle of "the destroyer" the demon meant to usher in the apocalypse. In the midst of the torture, Hellboy agrees- and goes to unlock the key to the pit with his own arm- built exactly for this moment, when through the moans of demonic forces ready to attack on the other side of the door, Hellboy hears the other captured agent, "You have a choice, your father gave it to you." He then tosses the crucifix Hellboy's father always wore, and as it burns a cross shape in his hellish hand- Hellboy looks at the evil forces that are making him do this, and fights back. –Jim L. Wilson and Chris Tomlinson
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Vegetarian isn't a byword for healthy, but following a balanced vegetarian diet can help you to lose weight on phentermine. So, whether you want to eat less meat to help weight loss, or you're a vegetarian looking for healthy eating advice, we've put together this guide to following a vegetarian diet on phentermine. Types Of […]Read more
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- Internships /
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- Graphic Design Intern
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Law Student or Paralegal Student - Internship for academic creditLanin Law P.C.
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Graphic Design InternBookmark This
Posted: July 28 2015
Company Location: McDonough, GA
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"I chose to transfer to Lake Superior State University because of the personal attention I would receive. I did not want to attend a large university where I would be a number lost in the masses. The well-rounded curriculum allowed me to obtain my position at John Deere. Having a good balance of theory and hands-on knowledge is critical for my position and Lake State gave me a good foundation in these skills."
Maria DiValentin, Mechanical Engineering 2001
Field Service Representative,
John Deere Power Systems
Waterloo, IA
Jim Sherman received an extra special retirement gift during commencement ceremonies on Saturday at
Lake Superior State University.
The accounting professor of 29 years was selected by his students and colleagues as this year's
recipient of the LSSU Distinguished Teaching Award. The award is kept secret until it is announced at
commencement each year.
"Jim is considered to be highly professional by both students and colleagues," said Don McCrimmon,
Ph.D., LSSU Executive Vice President and Provost, in announcing the award. "He is an expert teacher who
draws upon experience to show students the application of the theory. His philosophy and attitude are
inspirational, and he tends to bring out the best in students."
"He is fair and honest," McCrimmon continued. "He is the most friendly and helpful faculty member in
the College of Business and Economics, and perhaps the University."
One of the students who nominated Sherman for the award called him "...a role model to aspire to"
and said he is considering following Sherman's lead to become an educator so he may have a positive
influence on the lives of students.
An alumnus of Lake State - he attended from 1959-1961 - Sherman received a bachelor's degree in
administration from Northern Michigan University, and a master's degree in accounting from Southern
Illinois University. He is a certified public accountant.
He was hired at LSSU in September 1971 as an assistant professor in the Business Administration
Department, earning tenure in 1976.
"Jim has certainly been a credit to this institution," said LSSU President Robert Arbuckle, Ph.D. "He
has been one of the builders of academics here at Lake State."
Sherman expressed surprise in accepting the award, but said he will forever savor the day and that he
shares the honor with his students.
Sherman and his wife, Judith, have six children. Upon his retirement, they will be leaving Sault Ste.
Marie to settle in eastern Tennessee.
A committee comprised of the five most recent recipients of the award, as well as several graduating
seniors with the highest grade point averages in their class, chooses the current award recipient from
the nominations submitted by LSSU employees and students.
Also during commencement ceremonies, former Lt. Gov. Connie Binsfeld was issued an honorary degree,
alumnus Dan Goodrich of Cedarville received the Paul Ripley Award for Young Alumni, and senior Sophia
Chandauka of Zimbabwe addressed the graduating class.
Exclusive Invitation to Present
Honorable Mention
Lake Superior State University
LSSU was one of five finalists that were invited to present papers at the conference. The other universities that were invited were: Cornell University, Michigan Tech, Air Force Academy, and University of Puerto Rico.
2006 UPADI Pan American Federation of Engineering Societies Convention for Engineers
Design Competition
Sept. 19-22, 2006
Atlanta, Georgia
Learn More...
-Computer Eng.
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text:
ERIC Number: ED245111
Record Type: RIE
Publication Date: 1981-Aug-14
Pages: 31
Abstractor: N/A
Reference Count: 0
Adult Education Guidance and Counselling Services in the United Kingdom. European Network of Interaction Projects in Adult Education.
Frischkopf, A.; Braun, J.
This document is a report of a visit to the United Kingdom in May 1981, to research the types and functions of the adult education guidance and counselling services available there. The report is organized in five sections. The first two sections provide a rationale for educational guidance and counselling for adults and describe the adult education system in Great Britain. Included is information on the legal bases, organizational structure, and participation in adult education. In the third section, the authors describe the situation of guidance services in continuing education in England. They found that there is little government financial support for such services and that political investment and economical resources were lacking in England. The fourth section describes the authors' visit to three further education guidance centers in London, Hatfield, and Bradford. Information is given on the history of each center, its operations, its staff and facilities, services provided, types of clients, and future plans. The final section of the report focuses on continuing education guidance in Sweden, the Federal Republic of Germany, and Denmark as a comparison to the situation of guidance services in the United Kingdom. Appendixes to the report include reports of visits to two institutes of continuing education in London, a directory of educational guidance services for adults, and a list of participants. (KC)
Publication Type: Reports - Research
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: Council for Cultural Cooperation, Strasbourg (France).
Identifiers: Denmark; Sweden; United Kingdom; West Germany
Note: Report of the visit to information, guidance and counselling centres in the United Kingdom (May 18-21, 1981) with an overview of the situation of similar services in Denmark, the Federal Republic of Germany, and Sweden.


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THIS IS A DIRECTORY PAGE. Britannica does not currently have an article on this topic.
Learn about this topic in these articles:
ocean acidification
...at the surface descends with dense, cold water as part of the thermohaline circulation. The acidic lower layers of the ocean are separated from the upper layers by a boundary called the " saturation horizon." Above this boundary there are enough carbonates present in the water to support coral communities. In midlatitude waters and in waters closer to the poles, many so-called...


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Oil Rubbed Bronze Metal Base With A Light Gray Over Wash Accented With Crystal Details. The Tapered Rectangle Hardback Shade Is An Oatmeal Linen Fabric With Natural Slubbing.
The Lamps Vitava Oil Rubbed Bronze Lamp by Uttermost from Becker Furniture World. We proudly serve the Twin Cities, Minneapolis, St. Paul, Minnesota area. Product availability may vary. Contact us for the most current availability on this product.
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Kenny could have survived. He could have crawled into a garbage container(Ben version) while walkers were eating Ben, hence he didn't scream.
Not sure about the Christa version.
Not sure about the Christa version.
This.plaqueconspiracy;731883 said:Lee could walk slowly through a whole horde of walkers with only a cleaver and not get bit once. Maybe Kenny could've tackled some of them and made it out alive somehow.
And maybe he gets bitten like Lee but makes it out alive anyway. He decides to go to the train and there he meets Christa and Omid. BUT, as he said earlier... He don't know if he would've shown his bite if he got bitten...
He doesn't tell them.
dunn dunn duuuunnnn
I think it says he was lost to the herd, not killed by. Even more ambiguity.Ninnuendo;732035 said:The whole Kenny Dying thing is a bit strange. Telltale don't show it, it's left quite intentionally ambiguous and then when the game is finished, a summary comes up saying he died. What was that point?
It is weird that it says "lost to the herd" when Carley was "killed by Lily" and Doug was "killed by walkers". Something's up. Perhaps they did it intentionally just to make you think about it. Maybe they want to show that you sometimes you just never see your close ones again not knowing what happened to them.RedKoolLoops;732044 said:I think it says he was lost to the herd, not killed by. Even more ambiguity.
I personally think he's a goner though. He never went down into the walkers with any intention other than to sacrifice himself saving another. He knew what he was doing.
... then he runs off-screen and you don't see anything else.Rock114;732108 said:Kenny died. In my game he said Kat gave him hell every night for not thinking of others more, and that was right before he jumped down to save Christa. He decided to do what Kat told him, and he thought about someone else first when he jumped down into the room to help Christa. He knew everyone who went to save him would get killed, which is why he shouted for them to go on and save Clem without him. Just because you don't see him die doesn't mean he didn't. There was no way out of that room. It was too dark for him to be able to get through the walkers and find an exit.
There was no way hiding in a trash can would have saved him in the alley. The walkers would have seen him jump in, and still would have killed him. He even says if you tell him that Kat wouldn't want him to do this, he says "Either I save the kid, or I get to see Kat again." He had no intention of leaving that alley alive, at least without Ben. He probably tried to fight off the walkers at first, but realized that there were too many. He used the final bullet in the gun to mercy kill Ben and spare him the pain of being eaten alive, because it's what Kat would have wanted him to do.


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In the UK, around 5,000 teenagers are admitted to hospital every year for alcohol-related reasons and binge drinking among young people has become commonplace. Now new research helps to explain why some teenagers are more proneLying face-downwards. to drinking alcohol than others.
The recent study carried out by King's College London's Institute of Psychiatry (IoP) and published in Proceedings of National Academy of Sciences (PNAS) provides a detailed understanding of those processes of the brain that are involved in teenage alcohol abuse.
Snow sports remain extremely popular winter pastimes and it is estimated that there are currently more than 200 million skiers and 70 million snowboarders in the world. Over recent years awareness of the benefits of wearing a helmet on the slopes has been increasing and new research has now demonstrated that the use of helmets reduces the risk of serious injury and saves lives.
A new initiative has been launched that aims to reduce red tape in public health and social care. Part of the Red Tape Challenge, the government's drive to reduce unnecessary regulation, the scheme invites members of the public and health professionals to comment on more than 500 Department of Health regulations covering a range of areas including the NHS, quality of care and professional standards.
November becomes Movember once again for the moustache growing charity event. The campaign aims to raise funds and awareness for men's health and in particular prostateA gland that surrounds the urethra near the bladder. It produces a fluid that forms part of the semen. and testicularRelating to the testicles. cancerAbnormal, uncontrolled cell division resulting in a malignant tumour that may invade surrounding tissues or spread to distant parts of the body.. By encouraging men to get involved Movember hopes to raise awareness of the health issues that affect men and to ultimately change the face of men's health. Prostate cancer is the most common cancer in men and it causes approximately 10,000 deaths in the UK each year.
Movember 2013 Key Health Messages
In the UK 1 in 6 people suffer from some degree of hearing loss. If this condition is left untreated it can result in feelings of frustration, isolation and even depressionFeelings of sadness, hopelessness and a loss of interest in life, combined with a sense of reduced emotional well-being. Despite the negative impact that hearing loss can have on quality of life, only 1 in 10 sufferers will seek help from the onset, with some waiting for up to 10 years before seeking assistance.
In 1982, world-renowned vet Dr Bruce Fogle, and Lady Beatrice Wright of the Royal National Institute for Deaf People (now called Action on Hearing Loss), introduced to the UK a charity that has gone on to radically change the lives of over 1600 deaf people right across the country.
The scheme was launched following a trip to the USA where Bruce attended an event at Washington State University where he came across the American Hearing Dog Scheme. This scheme involved training dogs to alert deaf people to a range of sounds in the home, workplace, and public buildings.
As the days are at their longest, my sleep is at its shortest and it's got me wondering about how much sleep I actually need. I have often stated that without the recommended 8 hours I am a zombie, but who recommended those magical 8 hours, and are they right for everyone?
Helen Money, Nutritionist
Preparing and cooking food alters nutritional composition. Cooking food does generally lower vitaminEssential substances that cannot be produced by the body and so must be acquired from the diet. content but to varying extents.
This week (30th April - 6th May) is MSmultiple sclerosis Awareness Week and the Multiple Sclerosis Trust are reminding people to Be Bold in Blue in order to raise awareness of this common neurological
Associated with the nervous system and the brain.
condition, the most common condition of its kind in the UK. Senior doctors have warned that not enough is known about MS and that most people in the country do not understand the symptoms of multiple sclerosisA progressive disease of the central nervous system., nor its prognosisAn assessment of the likely progress of a condition. or treatment.
Associated with the nervous system and the brain.
Recent television programmes and press articles have highlighted surgeons' concerns regarding metal on metal hip replacements to the point where some say they should no longer be used. Several manufacturers have already withdrawn this type of implant. The metal on metal debate is complex and can be confusing to the lay person as all hip replacements contain at least one metal component.
This site complies with the HONcode standard for trustworthy health information, a regularly monitored ethical standard aimed at offering quality health information.
Continuous improvement requires feedback and your opinions count. Do you have a few minutes to tell us what you think about this site?


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Jean Mallery Lennon, the daughter of Dr. and Mrs. Arthur J. Lennon of Bronxville, N.Y., was married yesterday to Kevin Phillip Weinfurt, the son of Dr. and Mrs. Phillip T. Weinfurt of Brookfield, Wis. The Rev. Daniel C. O'Connell performed the ceremony at Holy Trinity Roman Catholic Church in Washington.
The couple, both 27, are doctoral candidates in Washington, she in developmental psychology at George Washington University and he in general psychology at Georgetown University. Next month, Mr. Weinfurt is to become an assistant professor in psychiatry at the Georgetown University Medical Center.
Mrs. Weinfurt graduated cum laude from Connecticut College. Her father, a cardiologist and geriatrician, is the vice president for medical services at the Isabella Geriatric Center in New York. Her mother, a cardiologist known professionally as Dr. Airlie A. C. Cameron, is the medical director of ambulatory care at St. Luke's-Roosevelt Hospital Center in New York. The bride's parents are also associate professors at the Columbia University College of Physicians and Surgeons.
Mr. Weinfurt graduated summa cum laude from Loyola University in Chicago. His father is the manager of new technology assessment and development at Marquette Medical Systems, a hospital equipment manufacturer in Milwaukee.Continue reading the main story


text:
News By Tag
Industry News
News By Place
Industry News
Health & Safety Jobs on the Go via Convert Recruitment's New Mobile App
Convert Recruitment becomes the first recruitment agency to release a mobile app for health & safety jobseekers.
The app, which has been designed and developed by KeyApps (http://www.keyapps.co.uk)
Features include the ability to upload CVs; browse, search and apply for jobs whilst on the go; receive interview documents and sync interviews with the device's calendar, and keep up to date with the latest news.
"Our app will allow us to interact more effectively with our candidate base. It will enable us to provide active jobseekers with immediate access to the latest jobs as they arrive. The combination of personal profiling and push technology gives an improved level of bespoke and professional service" said Steve Hancock – Co Founder & Director of Convert.
Currently available to download for iPhone and Android, versions for Windows Phone and the iPad will soon be available.
'It's been a pleasure working with Steve and we are excited by the release of the first recruitment agency app dedicated to delivering HSE roles to jobseekers. It gives Convert Recruitment a fantastic advantage in their niche, and we have no doubt their candidates will appreciate having such a user-friendly way of searching for jobs on the go. New versions and updates will be coming soon,' commented Samantha Dawkins, Executive Admin Assistant at KeyApps.
Download for free from the AppStore (https://itunes.apple.com/
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Ordered Pairs
Complete the given ordered pairs so tht each ordered pair satisfies the given equation
X + 2y = 1: (0, ), (-2, ), (2, )
Solution Preview
subsitute the values for x in the equation
when x = 0
0 + 2y = ...
Solution Summary
Ordered paris that satisfy a given equation are found. The solution is detailed and well presented. The response was given a rating of "5/5" by the student who originally posted the question.


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Geomagic Touch Device Drivers is an application which allows you to control Touch Device. Before installing the new Geomagic Touch Device Driver, you must first uninstall any previous versions of the Phantom Device Driver (PDD) that you have installed on your system.
Device driver matching your needs - no matter what windows version you're using. Now you can finally use the same driver update tools used by PC technicians and eliminate any guess work and time waste in the process of updating your drivers. No more headache and no more countless hours looking for help in hardware manufacturer sites.
The AzRockey.exe program installs the newest Rockey4 Device Drivers so EVERKEY programs can access Rockey4 Keys.
This release supports "silent install" so you can suppress all Az-Tech screens and logos. These drivers support all EVERKEY Version 6 programs including the Kechk32.dll and Renew32.exe programs from Version 2.
USB Drivers Download Utility will walk you through updating, backing-up, restoring and deleting drivers. When your drivers are managed properly your PC and hardware can show increased speed, stability, performance and new features. Hardware manufacturers are constantly improving their products and often release several driver updates a year.
Device drivers play a very important role in your system as they allow it to communicate with your physical and virtual devices. So, keeping drivers appropriate and up-to-date is an advisable action you should take to make good use of your PC or laptop. DriverMax is a handy tool that detects your faulty, outdated or missing device drivers, and helps you solve those problems.
Asus Drivers Download Utility is a professional driver updating program which can keep your PC running efficiently and effectively with advanced system drivers. By removing old drivers before installing new drivers you will ensure that your PC will reach its maximal potential and performance.
IBM Drivers Download Utility is a professional driver updating program which can keep your PC running efficiently and effectively with advanced system drivers. By removing old drivers before installing new drivers you will ensure that your PC will reach its maximal potential and performance.
Samsung Drivers Download Utility has been the industry leader in driver update software for years. The software has a huge driver database, has been downloaded millions of times, and is known to be the best product online. Samsung Drivers Download Utility is essential part of your computer.
DriverToolkit is a smart program that makes sure that your drivers are not a cause of problems for your computer. It does that by scanning your system for missing, broken, or outdated drivers and offers you to download and install the needed ones. It can do that even for unknown devices that aren't yet recognized by the system.
DriverEasy is an app that finds drivers for the hardware devices in your computer and updates the existing ones. It scans your computer, tells you what drivers are missing or outdated, then updates them all, in one go. All you have to do is click Update All button, and all drivers will be downloaded and installed automatically.
DriverIdentifier has been created with the exact purpose of detecting the latest drivers for all the connected hardware, even when the infamous "unknown device" situation is encountered.
DriverIdentifier comes with plenty of advantages, including the fact that it's a reliable tool that rarely fails to provide you with the drivers you need.
3DP Chip will enables you to enumerate devices and download the latest device drivers with few simple clicks. You can use it just for enumerate the devices such as CPU, MOBO, Graphic Card, Sound Card and Ethernet Card. The app has an easy-to-use interface.
Driver Support is a fast, powerful and feature-rich driver updating utility that scans your computer for missing or outdated drivers and offers you a solution to download and install the latest releases of the needed drivers with ease, conveniently and quickly.
Drivers For Free - Download the latest Windows 7, Vista and XP drivers for your computer.
Complete Your Drivers For Free Unlimited Registration Now to Update Missing or Outdated Device Drivers on Your Windows Computer.
Access to 27+ million device associated drivers.
Machine-Specific Driver Recommendations.
My-Config.com allows you to detect the configuration of a computer not connected to the Internet, as long as you have access to another computer connected to the Internet. This service is also very convenient for a computer whose network card is not recognized.
Driver Whiz is a program that scans your computer system and hardware devices to locate the most up-to-date drivers from a database of over 11 million drivers. The program checks driver compatibility with your computer's manufacturer to update the correct drivers.
DriverPack Solution is a handy tool meant to take care of various driver-related problems. This application has been created to fix unidentified devices by detecting them and downloading proper drivers that allow you to use these devices as they should.
Driver Magician offers a solution for device drivers backup, restoration, update, and removal in Windows operating system. It identifies all the hardware in the system, extracts their associated drivers from the hard disk and backs them up to a location of your choice.


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July 19, 2012
DEWAYNE PARKER,PETITIONER,v.ON HABEAS CORPUS, RESPONDENT.
ORDER GRANTING PETITIONER'S MOTION TO WITHDRAW PETITION FOR WRIT OF HABEAS CORPUS AND DIRECTING CLERK OF COURT TO CLOSE CASE [Doc. 5]
Petitioner is proceeding pro se with a petition for writ of habeas corpus pursuant to 28 U.S.C. § 2254.
On July 9, 2012, Petitioner filed a motion to withdraw the petition for writ of habeas corpus. Pursuant Federal Rule of Civil Procedure 41(a)(1)(I), a plaintiff may voluntarily dismiss an action without a court order if the notice of dismissal is filed before the opposing party serves either an answer or motion for summary judgment or upon stipulation by all parties. At this stage in the proceedings, Petitioner has the absolute right to dismiss his claims, without prejudice. Duke Energy Trading and Marketing, L.L.C. v. Davis, 267 F.3d 1042, 1049 (9th Cir. 2001). The filing of the notice itself has the effect of closing the action, and the Court no longer has jurisdiction over the claims. Id.
Accordingly, the Clerk of the Court is HEREBY DIRECTED to close this file pursuant to Petitioner's notice of voluntary dismissal filed on July 9, 2012.
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