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Second Request for Reconsideration for Refusal to …...ESSENTIALS LIST (STATE OF MICHIGAN)." Letter...

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United States Copyrig.ht Office l 1brary ot Congress . 101 Independence A,enue SE · Washington, DC 20559-6000 www.cop)right.gov Ri chard A. Hennan, Esq. 30850 Telegraph, Suite 250 Bingham Fanns. M1 48025 March 16, 20 17 Re: Second Request for Reconsideration for Refusal to Register 2015 EIDM Essentials List; Correspondence ID : 1-l GLHJER; SR # l-2061432731 Dear Mr. Herman: The Review Board of the United States Copyright Office ( .. Board"') has consid ered EHl M' s second request for reconsideration of th e Registrati on Progr am's refusal to register a text claim in the work tit led ·'2015 EHIM Essentials List" ("Work"). After reviewing the applicati on, deposit copy, and relevant correspo nd ence, along with the arguments in the second request for reconsideration, the Board affirms the Registration Program· s denial of registration. I. DESC RI PTION OF THE WORK The Work is 636 pages of text consisting of several introductory paragraphs foll owed by schedules of pharmaceutical products organized in alphabetical order by state. The introductory paragraphs are identical to those included in the work titled ··EHL\1 ESSENTIALS LIST (STATE OF MJCHIGAN)," registered on December 18, 20 14 under the registration number TXu 1-934-686. Within each state schedule, the pharmaceutical products are listed fi rst alphabetically according to type. For example, under the schedule fo r the State of Alabama, the first category is ··Analgesics - Nonsteroidal Anti-Inflammatory Drugs." Nineteen specific pharmaceutical products are listed under this cat egory, not in al ph abetical o rd er. but according to some other methodology. An excerpt of the Work is included in Appendix A. II. ADMI ISTRATI VE RECORD On January 15, 2015, EHIM fi led an application to register a copyright claim in the Work. ln a July 27, 2015 letter, a Copyright Office registration specialist refused to register the claim, finding that ·'the material deposited represents less than the required minimum am oun t of original authorship on which to base a claim." Letter from Duke Latkovic, Senior Registration Specialist. to Richard Hennan (July 27. 2015).
Transcript
Page 1: Second Request for Reconsideration for Refusal to …...ESSENTIALS LIST (STATE OF MICHIGAN)." Letter from Stephanie Mason, Attorney Advisor, to Richard Herman (Mar. 3, 2016). In a

United States Copyrig.ht Office l 1brary ot Congress . 101 Independence A,enue SE · Washington, DC 20559-6000 • www.cop)right.gov

Richard A. Hennan, Esq. 30850 Telegraph, Suite 250 Bingham Fanns. M1 48025

March 16, 2017

Re: Second Request for Reconsideration for Refusal to Register 2015 EIDM Essentials List; Correspondence ID: 1-l GLHJER; SR # l -2061432731

Dear Mr. Herman:

The Review Board of the United States Copyright Office ( .. Board"') has considered EHlM' s second request for reconsideration of the Registration Program's refusal to register a text claim in the work titled ·'2015 EHIM Essentials List" ("Work"). After reviewing the application, deposit copy, and relevant correspondence, along with the arguments in the second request for reconsideration, the Board affirms the Registration Program· s denial of registration.

I. DESCRIPTION OF THE WORK

The Work is 636 pages of text consisting of several introductory paragraphs followed by schedules of pharmaceutical products organized in alphabetical order by state. The introductory paragraphs are identical to those included in the work titled ··EHL\1 ESSENTIALS LIST (STATE OF MJCHIGAN)," registered on December 18, 2014 under the registration number TXu 1-934-686. Within each state schedule, the pharmaceutical products are listed fi rst alphabetically according to type. For example, under the schedule for the State of Alabama, the first category is ··Analgesics - Nonsteroidal Anti-Inflammatory Drugs." Nineteen specific pharmaceutical products are listed under this category, not in alphabetical order. but according to some other methodology.

An excerpt of the Work is included in Appendix A.

II. ADMI ISTRA TIVE RECORD

On January 15, 2015, EHIM fi led an application to register a copyright claim in the Work. ln a July 27, 2015 letter, a Copyright Office registration specialist refused to register the claim, finding that ·'the material deposited represents less than the required minimum amount of original authorship on which to base a claim." Letter from Duke Latkovic, Senior Registration Specialist. to Richard Hennan (July 27. 2015).

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Richard A. Herman, Esq. - 2 - March 16, 2017

In a letter dated October 7, 2015, EHIM requested that the Office reconsider its initial refusal to register the Work. Letter from Richard A. Herman to U.S. Copyright Office (Oct. 7, 2015) ("First Request") . After reviewing the Work in light of the points raised in the First Request, the Office re-evaluated the claims and again concluded that the Work "does not contain any new textual authorship to support a second copyright registration," noting that "the text contained in [the Work] was the same as the text registered in EHIM ESSENTIALS LIST (STATE OF MICHIGAN) ." Letter from Stephanie Mason, Attorney­Advisor, to Richard Herman (Mar. 3, 2016).

In a letter dated May 31, 2016, EHIM requested that, pursuant to 37 C.F.R. § 202.5(c), the Office reconsider for a second time its refusal to register the Work. Letter from Richard A. Herman to U.S. Copyright Office (May 31, 2016) ("Second Request"). In that letter, EHIM admitted that ''the introductory text is, in fact, the same." Id at 1. However, EHIM argued that "a minimum amount of originality and creativity exists, apart from the introductory text, to support registration," and that "[w]hile certain information and facts may not be copyrightable, compilations containing such information/facts may still contain that amount of originality necessary for registration." Id at 2.

Ill. DISCUSSION

A. The Legal Framework: Originality

A work may be registered if it qualifies as an "original work[] of authorship fixed in any tangible medium of expression." 17 U.S.C. § 102(a). In this context, the term "original" consists of two components: independent creation and sufficient creativity. See Feist Pub! 'ns, Inc. v. Rural Tel. Serv. Co. , 499 U.S. 340, 345 (1991 ). First, the work must have been independently created by the author, i.e., not copied from another work. Id. Second, the work must possess sufficient creativity. Id. Only a modicum of creativity is necessary, but the Supreme Court has ruled that some works (such as the alphabetized telephone directory at issue in Feist) fail to meet even this low threshold. Id. The Court observed that "[a]s a constitutional matter, copyright protects only those constituent elements of a work that possess more than a de minimis quantum of creativity." Id. at 363. It further found that there can be no copyright in a work in which ''the creative spark is utterly lacking or so trivial as to be virtually nonexistent." Id. at 359.

The Office's regulations implement the longstanding requirement of originality set fo rth in the Copyright Act and described in the Feist decision. See, e.g., 37 C.F.R. § 202. l(a) (prohibiting registration of " [w]ords and short phrases such as names, titles, slogans; familiar symbols or designs; [and] mere variations of typographic ornamentation, lettering, or coloring"); id. § 202.l O(a) (stating ''to be acceptable as a pictorial, graphic, or sculptural work, the work must embody some creative authorship in its delineation or form"). Some combinations of common or standard design elements may contain sufficient creativity with respect to how they are juxtaposed or arranged to support a copyright. Nevertheless, not every combination or arrangement will be sufficient to meet thi s test. See Feist, 499 U.S. at 358 (finding the Copyright Act " implies that some ' ways' [ of selecting, coordinating, or

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Richard A. Herman, Esq. -3- March 16, 2017

arranging uncopyrightable material] will trigger copyright, but that others will not"). A determination of copyrightability in the combination of standard design elements depends on whether the selection, coordination, or arrangement is done in such a way as to result in copyrightable authorship. Id; see also Atari Games Corp. v. Oman, 888 F.2d 878 (D.C. Cir. 1989).

A mere simplistic arrangement of non-protectable elements does not demonstrate the level of creativity necessary to warrant protection. For example, the United States District Court for the Southern District of New York upheld the Copyright Office's refusal to register simple designs consisting of two linked letter "C" shapes "facing each other in a mirrored relationship" and two unlinked letter "C" shapes "in a mirrored relationship and positioned perpendicular to the linked elements." Coach, Inc. v. Peters, 386 F. Supp. 2d 495, 496 (S.D.N.Y. 2005). Likewise, the Ninth Circuit has held that a glass sculpture of a jellyfish consisting of clear glass, an oblong shroud, bright colors, vertical orientation, and the stereotypical jellyfish form did not merit copyright protection. See Satava v. Lowry , 323 F.3d 805, 811 (9th Cir. 2003). The language in Satava is particularly instructive:

It is true, of course, that a combination of unprotectable elements may qual ify for copyright protection. But it is not true that any combination of unprotectable elements automatically qualifies for copyright protection. Our case law suggests, and we hold today, that a combination of unprotectable elements is eligible for copyright protection only if those elements are numerous enough and their selection and arrangement original enough that their combination constitutes an original work of authorship.

Id. (internal citations omitted).

B. Analysis of the Work

After carefully examining the Work and applying the legal standards discussed above, the Board finds that the Work does not contain the requisite separable authorship necessary to sustain a claim to copyright.

EHIM has already acknowledged that the introductory text on the first page of the Work is identical to that prefacing the work "EHIM ESSENTIALS LIST (ST A TE OF MICHIGAN)," registered on December 18, 2014 under registration number TXu 1-934-686. Therefore, the Board considers only the lists of pharmaceutical products on pages 2 through 636.

EHIM does not seek to register a copyright claim in the name of each pharmaceutical product, of course, but solely in the selection and arrangement of these product names. See Second Request at 2. It argues that the compilations of pharmaceutical product names are "original works of authorship, maintaining the requisite amount of creativity in and of themselves." Id. It is undisputed that uncopyrightable elements may be protectable if selected and combined " in a distinctive manner indicating some ingenuity." Atari Games Corp., 888 F.2d at 883. And EHIM correctly notes that "compilations containing ...

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Richard A. Herman, Esq. -4- March 16, 2017

information/facts may still contain that amount of originality necessary for registration." Second Request at 2.

However, here the Board finds that the selection, coordination, and arrangement of the Work's basic elements----<)ategories of medications and names of medications-is insufficient to render the Work original. These are concededly unprotectable facts, and, as the Ninth Circuit stated in Satava, "a combination of unprotectable elements is eligible for copyright protection only if those elements are numerous enough and their selection and arrangement original enough that their combination constitutes an original work of authorship." 323 F.3d 805 at 811. Here, the alphabetical listing of states, within which are alphabetical listings of medication categories, with sub-categories also listed alphabetically, are arranged in as commonplace a manner as possible. EHIM states that "the compilation and selection of the medications were chosen by EHIM to be included, [and] the order in which they are placed was created by EHIM." Second Request at 2. However, EHIM does not demonstrate what it is about the compilation, selection, and order of placement of the medications that constitutes creative authorship. There is no indication that EHIM selected, based on any independent criteria, only certain medications to place in each sub-category, nor that the categories and sub-categories themselves are anything more than descriptive facts. While it is true that the medications are not listed within each sub-category in alphabetical order, EHIM presents no evidence that the order of listing embodies any creativity or is based on any organizing principle. Instead, the entire Work is merely a statement of the following fact, without more: EHIM's pharmacy benefits cover the drugs listed in the Work. See COMP£ :DIUM (THIRD) § 707 (listing facts as an example of a work that does not satisfy the requirements of section 102(a) of the Copyright Act).

Accordingly, the Board finds that the Work's selection, coordination, and arrangement of unprotectable facts and information do not demonstrate the creative authorship necessary for copyright registration.

IV. CONCLUSION

For the reasons stated herein, the Review Board of the United States Copyright Office affirms the refusal to register the copyright claim in the Work. Pursuant to 37 C.F.R. § 202.S(g), this decision constitutes final agency action in this matter.

BY: Chris Weston Copyright Office Review Board

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Richard A. Herman, Esq. -5 - March 16, 2017

APPENDIX:

Excerpt (pages 1-10) of "2015 EHIM Essentials List"

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• .... . -Effective Date : 1/ 1/ 2015

A pharmacy plan that utilizes an Out--0f-Pocket (OOP) maximum shall be calculated based on therapy classes that are considered Essential Health Benefits (EHBs) under healthcare law.

Only out--0f-pocket expenses for prescriptions that are included on this Essentials List AND covered within a group's plan design will accumulate towards the 2015 OOP Maximum. Medications that are not included in this list may be covered by the prescription program however the out--0f-pocket costs will not accumulate toward your out--0f-pocket maximum.

Please refer to the Prescription Benefit Handbook for a detailed description of your actual plan design & copay levels.

Some of the medications included in this list will be subject to your specific plan design and formulary requirements. Clinical management, such as Step Therapy, Prior Authorization, and/or Quantity Limits and may be utilized before a drug can be covered by your prescription program.

This list applies to FDA-approved generic drugs, even if those drugs are not specifically listed as generic at the lime of distribution.

This list is subject to change at any time without notice.

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State {or Territory) : ALABAMA Effective Date : 1 / 1/ 2015

ALABAMA

ANALGESICS • NONSTEROIDAL ANTI-INFLAMMATORY DRUGS

IBUPROFEN DICLOFENAC SODIUM NABUMETONE SUUNDAC

NAPROXEN ETODOLAC OXAPROZIN DIFLUNISAL

MELO XI CAM INDOMETHACIN PIROXICAM FENOPROFEN

KETOPROFEN MEFENAMIC ACID TOLMETIN

'ANALGESICS - OPIOID ANALGESICS, LONG-ACTING MORPHINE SULFATE SR

!ANALGESICS· OPIOID ANALGESICS, SHORT-ACTING

TRAMADOL

!ANESTHETICS • LOCAL ANESTHETICS UDOCAINE CREAM UDOCAINE/PRILOCAINE UDOCAINE PATCH

DICLOFENAC POTASSIUM KETOROLAC SALSALATE FLURBIPROFEN

!ANTI-ADDICTION/SUBSTANCE ABUSE TREATMENT AGENTS • ALCOHOL DETERRENTS/ ANn-CRAVJNG

DISULFIRAM CHANTIX CAMPRAL

!ANTI-ADDICTION/SUBSTANCE ABUSE TREATMENT AGENTS • OPIOID ANTAGONISTS BUPRENORPHINE NALOXONE

!ANTI-ADDICTION/SUBSTANCE ABUSE TREATMENT AGENTS • SMOKING CESSATION AGENTS

BUPROPION NICOTROL PATCH

!ANTIBACTERIALS • AMINOGLYCOSIDES GENTAMICIN TOBRAMYCIN AMIKACIN TOBI

KANAMYCIN

!ANTIBACTERIALS • ANnBACTERIALS, OTHER TRIMETHOPRIM NITROFURANTOIN

CHANTIX

NEOMYCIN PAROMOMYON

NITROFURANTOIN MACROCRYST ALS

CLINDAMYCIN HCL CLINDAMYCIN PHOSPHATE MUPIROCIN NEO/POLY/GRAMODIN TRIMETHOPRIM/POLYMYXJN B THERMAZENE VANDAZOLE METHENAMINE ZIANA (VELTIN)

!ANTIBACTERIALS - BETA·LACTAM, CEPHALOSPORINS

CEPHALEXIN CEFUROXIME CEFADROXIL CEFPROZIL CEFPODOXIME CEFACLOR CEDAX SUPRAX CEFOTETAN CEFOXITIN

!ANTIBACTERIALS - BETA-LACTAM, OTHER MEROPENEM INVANZ

!ANTIBACTERIALS- BETA-LACTAM, PENICILLINS PENIOLUN V AMOXICILLIN DICLOXACJWN PENIOLUN G OXACIWN PIPERACILLIN

!ANTIBACTERIALS - MACROLIDES AZITHROMYCIN ERYTHROMYCIN BASE

CLARITHROMYCIN

CEFAZOLIN CEFEPIME

AZACTAM

AMOXICIWN CLAVULANATE NAFCILLIN

ERYTHROMYCIN STEARATE

AK-TOB STREPTOMYCIN

METRONIDAZOLE

NEO/POL Y / BAC/HC BACITRACIN VANCOMYCIN

CEFDINIR CEFDITOREN PIVOXJL CEFTRIAXONE CEFTAZIDIME

AMPICILUN AMPICILUN/SULBACTAM

EYRTHROMCYIN ETHYLSUCCINATE

Tli1 documlrt n1 l'10 dlla n11o< inb1Nlion ccnlanod ii Hs '*>cl.moot ('1Mr!Nllon1 n - by EHi!. k contaN logat/ p:Mlogod CONlde,,tial nl propnetay nlonnalion - - P'"'*1Y al EltM Illa ,s ~mncilcloan l'rough ll!lJNffllffl(s} llldlor lilln11111roqoa• h roc,ponlto keep h lnlormallon conldenli& Tllelnlonnaion maync>1bo roproduood, chcl>sed, IIMCI and.a<,_ upon. 11- . or r, p-t _ ... pmrWltlln c:on.wt al EHJl,l nu lnlcrmaon is also mocxlod soiol\<"" .. ,..,.. and/or ..... dKlciz8d by EllM 1o ......... it "YO<J •• not h nll<ldod cec:ipiont. .... ncify EHIM and irMMdaloll' -----~t,o- ArryllUIJ1hariz»d 19produc:lion, disd>ol.n, 1COHS..,. atd/cr aclion11..a.nc.ontio lnlorm*"1 isA,cdy~ andmoyonitto EHlMtolegal and/or ..-...-anddnagos.

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Print Date: December 24, 2014 Page 2 of 636

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Ptt• '" , Int

State ( or Territory) : ALABAMA Effective Date: 1/1/2015

!ANnBACTERIALS - QUINOLONES

CIPROFLOXACIN LEVOFLOXACIN VIGAMOX ZYMAXID

!ANnBACTERIALS - SULFONAMIDES

SMO/TMP SODIUM SULFACETAMIDE

!ANnBACTERIALS - TETRACYCUNES

OFLOXACIN FACTIVE

SULFADIAZINE

AVELOX NOROXIN

TMP/POLYMYXIN

OOXYCYCUNE MINOCYCUNE TETRACYCLINE DEMECLOCYCUNE

!ANncoNVULSANTS - ANTICONVULSANTS, OTHER

LEVET1RACETAM BANZEL

!ANncoNVULSANTS - CALCIUM CHANNEL MODIFYING AGENTS

ZONISAMIDE ETHOSUXIMIDE L YRICA CELONTIN

!ANncoNVULSANTS - GAMMA-AMINOBUTYRIC ACID (GABA) AUGMENTING AGENTS

GABAPENTIN DIVALPROEX VALPROIC ACID PRIMIDONE TIAGIBINE

IANncoNVULSANTS-GLUTAMATE REDUONG AGENTS

LAMOTRIGINE TOPIRAMATE FELBAMATE

!ANnCONVULSANTS - SODIUM CHANNEL AGENTS

PHENYTOIN CARBAMAZEPINE OXCARBAZEPINE APTIOM EPITOL PEGANONE

!ANnDEMENTIA AGENTS - ANnDEMENTIA AGENTS, OTHER

ERGOLOID MESYLATES

IANTIDEMENTIA AGENTS - CHOUNESTERASE INHIBITORS

OONEPEZIL GALANTAMINE RIVASTIGMINE

IANTIDEMENTIA AGENTS - N-METHYL-D-ASPARTATE (NMDA) RECEPTOR ANTAGONIST

NAMENDA

ANTIDEPRESSANTS - ANTIDEPRESSANTS, OTHER

TRAZODONE BUPROPION MIRTAZAPINE NEFAZODONE MAPROTIUNE VII BRYD APLENZIN OLEPTRO

ANTIDEPRESSANTS - MONOAMINE OXIDASE INHIBITORS

PHENELZINE TRANYLCYPROMINE EM SAM MARPLAN

!ANTIDEPRESSANTS - SEROTONIN/NOREPINEPHRINE REUPTAKE INHIBITORS

FLUOXET1NE PAROXETINE SERTRAUNE CITALOPRAM VENLAFAXINE VIIBRYD

ESCITALOPRAM

!ANTIDEPRESSANTS - TRICYCUCS

AMITRIPTYUNE IMIPRAMINE DOXEPIN DESIPRAMINE AMOXAPINE

IANTIEMETICS - ANTIEMETICS, OTHER

DIPHENHYDRAMINE MECUZINE METOCLOPRAMIDE CYCUZJNE

EHIM 0 2014 (800) 311-3446

Print Date: December 24, 2014

TRIMETHOBENZAMIDE CESAMET

www.eh1mrx.com

FLUVOXAMINE

IMIPRAMINE PAMOATE CLOMIPRAMINE

PROCHLORPERAZINE DEXAMETHASONE

CYMBALTA

NORTRIPTYUNE PROTRIPTYUNE

PROMETHAZINE SCOPOLAMINE

Page 3 of636

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state (or Territory) : ALABAMA Effective Date : 1/1/2015

!ANnEMETICS - EMETOGENIC THERAPY AD~UNCTs ONDANSETRON MECLIZINE ANZEMET EMEND

jANnFUNGALS - ANTIFUNGALS

FLUCONAZOLE CLOTRIMAZOLE SELENIUM SULF1DE CICLOPIROX ITRACONAZOLE JUBUA

NYSTATIN/TRIAMCINOLONE MICONAZOLf KETOCONAZOLE CLO TRIM/BET A METH NOXAFlL

jANnGOUT AGENTS - ANTIGOUT AGENTS

METOCLOPRAMIDE

TERB1NAF1NE TERCONAZOLE GRISEOFULVIN FLUCYTOSINE CANCIDAS

ALLOPURINOL COLCRYS PROBENECID PROBENECID/COLCHIONE

ANTI-INFLAMMATORY AGENTS - GLUCOCORnCOIDS

METHYLPREDNISOLONE

GRANISETRON

NYSTATIN ECONAZOLf UNDECYLfNIC ACID VORICONAZOLE AMPHOTERICIN B

ULORIC

[ANTI-INFLAMMATORY AGENTS - NONSTEROIDAL ANTI-INFLAMMATORY DRUGS DICLOFENAC POTASSIUM IBUPROFEN

DICLOFENAC SODIUM NABUMETONE SULINDAC

NAPROXEN ETODOLAC OXAPROZIN DIFLUNISAL

MELOXICAM INDOMETHACIN PIROXICAM FENOPROFEN TOLMETIN KETOPROFEN MEFENAMIC ACID

IANTIMIGRAINE AGENTS - ERGOT ALKALOIDS

DIHYDROERGOTAMINE ISOMETHEPTENE/DICHLORALP HENAZONE APAP

ANTIMIGRAINE AGENTS - PROPHYLACTIC

PROPRANOLOL TIMOLOL TOPIRAMATE

IANTIMIGRAINE AGENTS - SEROTONIN (5-HT) 1B/1D RECEPTOR AGONISTS

SUMATRIPTAN

ANTIMYASTHENIC AGENTS - PARASYMPATHOMIMEncs PYRIDOSTIGMINE GUANIDINE REGONOL

ANnMYCOBACTERIALS - ANnMYCOBACTERIALS, OTHER

DAPSONE MYCOBUTIN

!ANnMYCOBACTERIALS - ANTITUBERCULARS ISONIAZID RI FAM PIN PRimN ISONARIF/RIFAMATE SEROMYCIN TRECATOR

!ANnNEOPLASTics - ALKYLAnNG AGENTS CYCLOPHOSPHAMIDE DACARBAZINE MATULANE LEU KE RAN

!ANnNEOPLASTics - ANTIANGIOGENIC AGENTS

REVUMID THALOMID

!ANnNEOPLASTics - ANTIESTROGENS/MODIFIERS TAMOXIFEN FARESTON

ETHAMBUTOL CAPASTAT

CEENU ALKERAN

EMCYT

KETOROLAC SALSALATE FLURBIPROFEN

GUANFACINE

PYRAZINAMIDE RIFATER

IFOSFAMIDE

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Print Date: December 24, 2014 Page4 of636

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jANnNEOPLASTICS - ANnMETABOUTES

HYDROXYUREA MERCAPTOPURINE

[ANnNEOPLASTICS - ANnNEOPLASTICS, OTHER

AMIFOSTINE BLEOMYCIN COSMEGEN MITOMYCIN

IANnNEOPLASTICS - AROMATASE INHIBITORS, 3RD GENERAnoN

ANASTROZOLE LETROZOLE EXEMESTANE

IANTINEOPLASTICS - ENZVME INHIBITORS

TARCEVA GLEEVEC IR ESSA

!ANnNEOPLASTICS - MOLECULAR TARGET INHIBITORS

TARCEVA IRESSA

AFINITOR JAKAFI

SUTENT TASIGNA

!ANTINEOPLASncs - MONOCLONAL ANnBODIES

HU MIRA CIMZIA

!ANTINEOPLASncs - REnNOIDS TRETINOIN PANRETIN

!ANTIPARAsmcs - ANTHELMINncs PYRIMETHAMINE MEBENDAZOLE

!ANTIPARASmcs - ANTIPROTOZOALS HYDROXYCHLOROQUINE DAPSONE PRJMAQUINE QUINIDINE GLUCONATE COARTEM DARAPRIM

!ANnPARASmcs - PEDICULICIDES/SCABICIDES

PERMETHRIN UNDANE EU RAX STROMECTOL

[ANnPARKINSON AGENTS - ANnCHOLINERGICS

GLEEVEC NEXAVAR TYKERB

TARGRETIN

STROMECTOL

CHLOROQUINE QUALAQUIN FANSIDAR

MALATHION

BENZTROPINE RIVASTIGMINE GALANTAMINE

ANnPARKINSON AGENTS - ANnPARKINSON AGENTS, OTHER

COMTAN STALEVO TASMAR

ANnPARKINSON AGENTS - DOPAMINE AGONISTS

State (or Territory) : ALABAMA Effective Date: 1/ 1/ 2015

DACTINOMYCIN

INLYTA SPRYCEL VOTRJENT

MEFLOQUINE ATOVAQUONE/PROGUANIL MEPRON

NATROBA

ROPINIROLE PRAMIPEXOLE BROMOCRIPTINE APOMORPHINE

!ANnPARKINSON AGENTS - DOPAMINE PRECURSORS/L-AMINO ACID DECARBOXYLASE INHIBITORS

CARBIDOPNLEVODOPA LO DO SYN

!ANnPARKINSON AGENTS - MONOAMINE ox1DASE B (MAO-B) INHIBITORS

SELEGIUNE AZILECT

!ANnPsvcHoncs - 1ST GENERATION/TYPICAL

CHLORPROMAZINE TRIFLUOPERAZINE LOXAPINE

EHIM ()2014 (800) 311-3446

Print Date: December 24, 2014

HALOPERIDOL THI0R1DAZINE ORAP

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PROCHLORPERAZINE FLUPHENAZINE

THIOTHIXENE PERPHENAZINE

Page 5 of 636

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State ( or Territory) : ALABAMA Effective Date : 1/ 1/ 2015

jANTIPSYCHOTICS - 2ND GENERATION/ ATYPICAL R1SPERID0NE CLOZAPINE LATUDA

QUETIAPINE INVEGA

IANTIPSYCHOTICS - TREATMENT-RESISTANT ABILIFY

OLANZAPINE ABILIFY

jANTISPASTICITY AGENTS - ANTISPASTICITY AGENTS

CYCL0BENZAPR1NE BACLOFEN TIZANIDINE

!ANTIVIRALS - ANTl·CYTOMEGALOVIRUS {CMV) AGENTS

GANCICLOVIR VALCYTE

!ANTIVIRALS - ANTIHEPATITIS AGENTS INTRON A PEGASYS RIBAVIRIN EPIVIR HBV COPEGUS TYZEKA

!ANTIVIRALS - ANTIHERPETIC AGENTS ACYCLOVIR DENAVIR

VALACYCLOVIR

RIBAPAK HEPSERA VICTRELIS

FAMCICLOVIR

ZIPRASIDONE SAPHRIS

DANTROLENE

R1BASPHERE BARACLUDE INCIVEK

TRIFLURIDINE

!ANTIVIRALS - ANTI-HIV AGENTS, NON•NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS SUSTIVA ATRJPLA INTELENCE VI RAMU NE RESCRIPTOR

ANTIVIRALS - ANTI-HIV AGENTS, NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

ZIDOVUDINE COMBIVIR

VIREAD EPZICOM

EPIVIR TRIZIVIR

DIDANOSINE STAVUDINE VIDEX

!ANTIVIRALS - ANTI-HIV AGENTS, OTHER ISENTRESS SELZ ENTRY FUZEON

!ANTIVIRALS - ANTI-HIV AGENTS, PROTEASE INHIBITORS KALETRA PREZISTA REYATAZ APTIVUS CRIXIVAN

INVIRASE

!ANTIVIRALS· ANTI-INFLUENZA AGENTS

VIRACEPT

AMANTADINE TAMI FLU RELENZA

jANXIOL YTICS - ANXIOL YTICS, OTHER

EMTRIVA TRUVADA

LEXIVA NORVIR

BUS PIRONE CHLORDIAZEPOXlDE CHLORDIAZ/CLIDIN MEPROBAMATE

ANXIOLYTICS-SSRIS/SNRIS (SELECTIVE SEROTONIN REUPTAKE INHIBITORS/SEROTONIN AND NOREPINEPHRINE REUPTAKE INHIBITORS)

FLUOXETINE FLUVOXAMINE

PAROXETINE

!BIPOLAR AGENTS - BIPOLAR AGENTS, OTHER R1SPERID0NE QUETIAPINE OXCARBAZEPINE ABILIFY

!BIPOLAR AGENTS - MOOD STABIUZERS LITHIUM VALPROATE SODIUM

EHIM 0 2014 (800) 311-34'46 www.ehimrx.com

Print Date: December 24, 2014

SERTRALINE VENLAFAXINE

OLANZAPINE ZIPRASIDONE

LAMOTRIGINE CARBAMAZEPINE

Page 6 of636

Page 12: Second Request for Reconsideration for Refusal to …...ESSENTIALS LIST (STATE OF MICHIGAN)." Letter from Stephanie Mason, Attorney Advisor, to Richard Herman (Mar. 3, 2016). In a

••• IU r h at

State ( or Territory) : ALABAMA Effective Date: 1/1/ 2015

!BLOOD GLUCOSE REGULATORS - ANTIDIABETIC AGENTS METFORMIN GLIPIZIDE GLIMEPIRIDE PIOGUTAZONE ACARBOSE NATEGLINIDE GLYBURIDE/ METFORMIN PIOGUTAZONE/ METFORMIN PIOGLITAZI NE/ GUMEPIRIDE BROMOCRIPTINE PRANDIMET JANUVIA JENTADUETO AVANDIA AVANDARYL BYETTA

!BLOOD GLUCOSE REGULATORS- GLYCEMIC AGENTS

GLUCAGON PROGL YCEM

!BLOOD GLUCOSE REGULATORS - INSULINS HUMULIN NOVOLIN R NOVOUN N NOVO LOG HUMALOG LEVE MIR NOVOLOG MIX APIDRA

!BLOOD PRODUCTS/MODIFIERS/VOLUME EXPANDERS - ANTICOAGULANTS

WARF ARIN HEPARIN

GLYBURIDE GUPIZIDE/ METFORMIN CHLORPROPAMIDE JANUMET VICTOZA

NOVOLIN 70/ 30 LANTUS

!BLOOD PRODUCTS/MODIFIERS/VOLUME EXPANDERS - BLOOD FORMATION MODIFIERS

PROCRIT EPOGEN GRANIX ARANESP

NEUPOGEN NEUMEGA LEU KI NE

!BLOOD PRODUCTS/MODIFIERS/VOLUME EXPANDERS - COAGULANTS

CYKLOKAPRON

!BLOOD PRODUCTS/MODIFIERS/VOLUME EXPANDERS - PLATELET MODIFYING AGENTS CLOPIDOGREL CILOSTAZOL DIPYRIDAMOLE ANAGRELIDE AGGRENOX EFFIENT XAREL TO PRADAXA

CARDIOVASCULAR AGENTS - ALPHA-ADRENERGIC AGONISTS

CLONIDINE METHYLDOPA METHYLDOPA/HCTZ MIDODRINE

CARDIOVASCULAR AGENTS - ALPHA-ADRENERGIC BLOCKING AGENTS TAMSULOSIN DOXAZOSIN TERAZOSIN PRAZOSI N

'CARDIOVASCULAR AGENTS - ANGIOTENSIN JI RECEPTOR ANTAGONISTS LOSARTAN LOSARTAN/ HCTZ IRBESARTAN EPROSARTAN DIOVAN ATACAND MI CARD IS BENICAR

CARDIOVASCULAR AGENTS - ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS

LISINOPRIL USINOPRILJHCTZ RAMIPRIL QUINAPRIL TRANDOLAPRIL PERINDOPRIL

BENAZEPRIL FOSINOPRIL

CAPTOPRIL MOEXIPRIL

!CARDIOVASCULAR AGENTS - ANTIARRHYTHMICS

AMIODARONE SOTALOL

DI SOPYRAMIDE MEXILETINE

FLECAINIDE QUI NIDINE GLUCONATE

PROPAFENONE QUINIDINE SULFATE

TIKOSYN SO RINE

!CARDIOVASCULAR AGENTS - BETA-ADRENERGIC BLOCKING AGENTS

METOPROLOL TARTRATE CARVEDILOL BYSTOUC PINDOLOL

ATENOLOL LABETALOL ACEBUTOLOL

BISOPROLOL METOPROLOL SUCCINATE BETAXOLOL

PROPRANOLOL NADOLOL TIMOLOL

Tla-and lhl data and,cr inbmalion conuiled in la doc:unont(1nlormaonj n O'Mlld by EHlliol koantii1• "9aly prMogod, ccrddontial and propietay inlormation .-l'lllllloaual pr-1)' ol EHILI NI lapr- tandisd>s&n trcugh • ~•)aidiar las llalrlqlftl>ereciportto keep t,e lnlarmatianconlidontal. n. fnbmmoorr.ar not bo ,.-. disclooed. usod - llhd ._ n- a in pal, wll101.010 pri,r ....,con.,tolEHlliol Tlis lnlonnaMi .. b o inlBndod~ farlhlrec,piert--llJt>onzad by EHILl lo - 11. ttyou .. notlhoinllndod redplonl p1o .. no(fy EHILland inmodialoly -, ,t,oo .-.-deRoy t,e lnlcrmation. Ary lNUlhonzod reproducban. lbaoue. acx:ess, use ardOf action n lllar,ce 011 tle infarrnmOl111 A;cdy prohill1ild ancl ~ onlillt EHILl to legal -...,.,...-.anc1damages.

EHIM 0 2014 (800) 311-3446 www.ehimf'l<.com ·

mm II Print Date: December 24, 2014 Page 7 of636

Page 13: Second Request for Reconsideration for Refusal to …...ESSENTIALS LIST (STATE OF MICHIGAN)." Letter from Stephanie Mason, Attorney Advisor, to Richard Herman (Mar. 3, 2016). In a

State (or Territory) : ALABAMA Effective Date : 1/1/2015

!CARDIOVASCULAR AGENTS - CALCIUM CHANNEL BLOCKING AGENTS

AMLODIPINE NIFEDIPINE NIMODIPINE

DILTIAZEM FELODIPINE

VERAPAMIL NISOLDIPINE

!CARDIOVASCULAR AGENTS - CARDIOVASCULAR AGENTS, OTHER

NIFEDIPINE ISRADIPINE

PENTOXIFYLUNE EPLERENONE TEKTURNA TEKTURNA HCT

!CARDIOVASCULAR AGENTS - DIUREncs, CARBONIC ANHYDRASE INHIBITORS

ACETAZOLAMIDE METHAZOLAMIDE

!CARDIOVASCULAR AGENTS - DIUREncs, LOOP FUROSEMIDE BUMETANIDE TORSEMIDE EDECRIN

'CARDIOVASCULAR AGENTS - DIUREncs, POTASSIUM-SPARING SPIRONOLACTONE AMILORIDE SPIRINOLACTONE/HCTZ TRIAMTERENE/HCTZ

!CARDIOVASCULAR AGENTS - DIUREncs, THIAZIDE HCTZ CHLORTHAUDONE INDAPAMIDE METOLAZONE CHLOROTHIAZIDE METHYCLOTHIAZIDE

!CARDIOVASCULAR AGENTS - DYSUPIDEMICS, FIBRIC ACID DERIVAnVES FENOFIBRATE FENOFIBRIC ACID

!CARDIOVASCULAR AGENTS - DYSUPIDEMICS, HMG COA REDUCTASE INHIBITORS SIMVASTATIN ATORVASTATIN LOVASTATIN PRAVASTATIN FLUVASTATIN CRESTOR UVALO

'CARDIOVASCULAR AGENTS - DYSUPIDEMICS, OTHER NIACIN CHOLESTYRAMINE COLESTIPOL LOVAZA ZETIA VYTORIN

'CARDIOVASCULAR AGENTS - VASODILATORS, DIRECT-AcnNG ARTERIAL HYDRALAZINE NITROGLYCERIN NITROGLYCERIN

!CARDIOVASCULAR AGENTS - VASODILATORS, DIRECT-ACTING ARTERIAL/VENOUS

JSOSORBIDE MONONITRATE ISOSORBIDE DINITRATE NITROPRUSSIDE

CENTRAL NERVOUS SYSTEM AGENTS - ATIENnON DEFICIT HYPERACTIVITY DISORDER AGENTS, AMPHETAMINES

AMPHETAMINE SALTS DEXTROAMPHETAMINE VYVANSE METHAMPHETAMINE

CENTRAL NERVOUS SYSTEM AGENTS - ATIENnON DEFICIT HYPERACTIVITY DISORDER AGENTS, NON-AMPHETAMINES

METHYLPHENIDATE DEXMETHYLPHENIDATE MODAFINIL STRATTERA

!CENTRAL NERVOUS SYSTEM AGENTS - CENTRAL NERVOUS SYSTEM AGENTS, OTHER AMITRIPTYUNE TRAZODONE CAFFEINE NUEDEXTA

!CENTRAL NERVOUS SYSTEM AGENTS - FIBROMYALGIA AGENTS DULOXETINE LYRICA SAVELLA I CENTRAL NERVOUS SYSTEM AGENTS - MUL nPLE SCLEROSIS AGENTS COPAXONE BETASERON REBIF AMPYRA GILENYA TECFIDERA TYSABRI

EHIM Cl2014 (800) 311-3446 www.ehimrx.com

Print Date: December 24, 2014 Page 8 of 636

Page 14: Second Request for Reconsideration for Refusal to …...ESSENTIALS LIST (STATE OF MICHIGAN)." Letter from Stephanie Mason, Attorney Advisor, to Richard Herman (Mar. 3, 2016). In a

State (or Territory} : ALABAMA Effective Date : 1/1/2015

!DENTAL AND ORAL AGENTS • DENTAL AND ORAL AGENTS CHLORHEX1DINE DOXYCYCUNE TRIAMCINOLONE PASTE OROPHARYNGEAL CEVIUMINE KEPIVANCE LU RIDE

!DERMATOLOGICAL AGENTS • DERMATOLOGICAL AGENTS AMMONIUM LACTATE ERYTHROMYCIN ERYTHROMYCIN/BPO PODOFILOX SOLUTION IMIQUIMOD PROTOPIC

BENZOYL PEROXIDE SELENIUM SULFIDE METRONIDAZOLE ADAPALENE SOLARAZE TRffiNOIN

CUNDAMYCIN TOPICAL SODIUM SULFACETAMIDE TAZORAC CALCIPOTRIENE TRffiNOIN SANTYL

UVADEX EXELDERM VE REGEN FINACEA AVITA CLARAVIS OXSORALEN RE GRAN EX PLEXION

!ENZVME REPLACEMENT /MODIFIERS • ENZVME REPLACEMENT /MODIFIERS

ZEN PEP PANCREASE KUVAN ADAGEN CEREZYME

ALDURAZYME CYSTADANE

BUPHENYL CYSTAGON

FABRAZYME MYOZYME NAGLAZYME

!GASTROINTESTINAL AGENTS • ANnSPASMODICS, GASTROINTESTINAL

ATROPINE/DIPHENOXYLATE DICYCLOMINE ATROPINE DONNATAL HYOSCYAMINE

!GASTROINTESnNAL AGENTS - GASTROINTESnNAL AGENTS, OTHER

ATROPINE/DIPHENOXYLATE LACTULOSE LANSOPRAZOLE TRILYTE XENICAL

'GASTROINTESTINAL AGENTS - HISTAMINE (H2) RECEPTOR ANTAGONISTS

RANmDINE FAMOTIDINE NIZATIDINE

!GASTROINTESTINAL AGENTS - IRRITABLE BOWEL SYNDROME AGENTS

DICYCLOMINE PHENOBARB/HYOSC/ ATROP/S COP

!GASTROINTESTINAL AGENTS - LAXAnVES SENNOSIDES PEG 3350 LACTULOSE

!GASTROINTESTINAL AGENTS - PROTECTANTS SUCRALFATE MISOPROSTOL

!GASTROINTESTINAL AGENTS - PROTON PUMP INHIBITORS OMEPRAZOLE PANTOPRAZOLE LANSOPRAZOLE RABEPRAZOLE ZEGERID

'GENITOURINARY AGENTS - ANTISPASMODICS, URINARY OXYBUTYNIN TOLTERODINE TROSPIUM TOVlAZ VESICARE ENABLEX

!GENITOURINARY AGENTS - BENIGN PROSTAnc HYPERTROPHY AGENTS

TAMSULOSIN FINASTERIDE TERAZOSIN PRAZOSIN JALYN

ALFUZOSIN AVODART

'GENITOURINARY AGENTS • GENITOURINARY AGENTS, OTHER PHENAZOPYRIDINE BETHANECHOL BETHANECHOL

PILOCARPINE

AZELEX CUNDAMYCIN/BPO ULESFIA FLUOROURACIL ELIDEL EURAX ZONALON EPIDUO

NEXAVAR CEREDASE ELAPRASE

GL YCOPYRROLATE

URSODIOL

CIMffiDINE

ESOMEPRAZOLE

OXYTROL

DOXAZOSIN RAPAFLO

Tllll-and "'dala-intlrmationCOl'llanld in lhos doc:a.tnenl("1nlomaion1 ••- by EHllol lCCfltals logalf pririeged, -.i and~ infonn"'°"and,a nolo<*JolproponydEHIMllat 11 fl'o4ldld tom iiodowt tn,ugh .-,.nl(s) andlar - M'*l'*a 1ho r_,i1o keep h lnlorrr.*"1 ~ The 1n1ttMa1icc, may notbo repr0$JC9d, cid>sed. u»d - rtiod upon, 11 v,!lolt, or ii Pa\ -lho pnor - CC111W11 d EHIM. Tllll lnlormalion cs also inllonded sololy Jar llo reai-t .-oe.. amorized by EHIM 1D r-..e d. ff you•• notlho l1llnded r9Cipin. please notfy EHIM and mmociallt,, mm II - . otnd ---de~ 1ho lnlcrmalion. Any INUtlorillod reprO<ldo<,, cisdosre, acooss, uso ll'ld,or _,",....,..on lht lnlonnalon Is $l'ldty P'ohl>ilod and may ent,ie EHIM1D logal endJor ~-anddanagn.

'h••lll'I• y l • ntf h "'•••ftd

EHIM ()2014 (800) 311-3446 www.ehimrx.com

Print Date: December 24, 2014 Page 9 of636

Page 15: Second Request for Reconsideration for Refusal to …...ESSENTIALS LIST (STATE OF MICHIGAN)." Letter from Stephanie Mason, Attorney Advisor, to Richard Herman (Mar. 3, 2016). In a

State ( or Territory) : ALABAMA Effective Date : 1/ 1/ 2015

!GENITOURINARY AGENTS· PHOSPHATE BINDERS

CALCIUM ACETATE RENVELA RENAGEL

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING (ADRENAL) -GLUCOCORTICOIDS/MINERALOCORTICOIDS

HYDROCORTISONE BETAMETHASONE VALERATE BETAMETH DIPROP CLOBETASOL DESONIDE DESOXIMETASONE DIFLORASONE FLUOCINOLONE HYDROCORTISONE BUTYRATE HYDROCORTISONE VALERATE METHYLPREDNISOLONE MOMETASONE ALCLOMETASONE AMCINONIDE AUGMENTED BETAMETHASONE CLOBETASOL E DEXAMETHASONE FLUDROCORTISONE HALOBETASOL PREDNICARBATE CLO BEX CORTISONE SCALACORT

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING {PITUITARY) - HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING (PITUITARY)

DESMOPRESSIN CHORIONIC GONADOTROPIN GENOTROPIN SEROSTIM

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING (PROSTAGLANDINS) - HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING PROSTAGLANDINS)

ALPROSTADIL

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING {SEX HORMONES/MODIFIERS) -ANABOUC STEROIDS

OXANDROLONE ANADROL

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING (SEX HORMONES/MODIFIERS) -ANDROGENS

FIRST-TESTOSTERONE TESTOSTERONE DANAZOL ANDROXY

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING (SEX HORMONES/MODIFIERS) -ESTROGENS

CU MARA ACTIVE LL.A ALORA COMBI PATCH

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING (SEX HORMONES/MODIFIERS) -PROGESTINS

MEDROXYPROGESTERONE MEDROXYPRO ACETATE MEGESTROL PROGESTERONE MICRONIZED

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING {SEX HORMONES/MODIFIERS) -SELECTIVE ESTROGEN RECEPTOR MODIFYING AGENTS

EVISTA

HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING (THYROID) - HORMONAL AGENTS, STIMULANT /REPLACEMENT /MODIFYING (THYROID)

LEVOTHYROXI NE LIOTHYRONINE SYNTHROID

!HORMONAL AGENTS, SUPPRESSANT (ADRENAL) - HORMONAL AGENTS, SUPPRESSANT (ADRENAL)

LYSODREN

HORMONALAGENTS,SUPPRESSANT(PARATHYROID)-HORMONALAGENTS,SUPPRESSANT (PARATHYROID)

SENSIPAR

!HORMONAL AGENTS, SUPPRESSANT (PITUITARY) - HORMONAL AGENTS, SUPPRESSANT (PITUITARY}

CABERGOUNE SOMAVERT SANDOSTATIN

OCTREOTIDE SYNAREL

LEUPROU DE TRE LST AR LA

SOMATUUNE EUGARD

!HORMONAL AGENTS, SUPPRESSANT (SEX HORMONES/MODIFIERS} - ANTIANDROGENS

BICALUTAMIDE FLUTAMIDE NI LANDRON XTANDI 2YTIGA

'HORMONAL AGENTS, SUPPRESSANT (THYROID) - ANTITHYROID AGENTS

METHIMAZOLE PROPYLTHIOURACIL

EHIM C>2014 (800) 311-3446 www.ehimrx.com

Print Date: December 24, 2014 Page 10 of 636


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