IN THE UNITED STATES DISTRICT COURT WESTERN DISTRICT OF MISSOURI CENTRAL DIVISION

J.E.M., et al., v.

Plaintiffs,

BRIAN KINKADE, in his official capacity as Director of the Missouri Department of Social Services, et al.,
Defendants.

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Case No. 16-cv-04273-SRB

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ORDER

Before the Court is Plaintiffs’ Motion for Preliminary Injunction. (Doc. #2). For the

reasons stated below, the motion is granted in part.

Plaintiffs J.E.M. and J.L.M, Medicaid beneficiaries with Hepatitis C virus (“HCV”), seek

a preliminary injunction against Defendant Brian Kinkade in his official capacity as Director of

the Missouri Department of Social Services, and Joe Parks, M.D., in his official capacity as

Director of the MO HealthNet Division, enjoining them from applying certain Hepatitis C drug-

treatment policies and prior-authorization criteria that Plaintiffs argue exclude them from

medically-necessary, direct-acting antiviral treatment (“DAAs”). With the Defendants’

agreement, the Court grants Plaintiffs’ request for a preliminary injunction prohibiting

Defendants from requiring three months of negative drug and alcohol screens prior to submitting

requests for DAA approval. The Court finds, however, that an evidentiary hearing is necessary

before the Court can rule on the Plaintiffs’ request for a preliminary injunction prohibiting

Defendants from applying policies and prior authorization criteria regarding fibrosis scores

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because a material factual dispute exists regarding the medical necessity of treating all HCV patients with DAAs regardless of fibrosis score.
I. Procedural History
Plaintiffs are low-income Missouri Medicaid beneficiaries who are infected with HCV, a life-threatening, infectious, blood-borne disease. Defendants are officials who are in charge of the state’s Medicaid program called MO HealthNet. Plaintiffs filed their Complaint on October 18, 2016, including three claims for relief: 1) a 42 U.S.C. § 1983 claim for failure to provide medically-necessary prescription drugs in violation of 42 U.S.C. §§ 1396a(a)(10)(A) and 1396d(a); 2) a 42 U.S.C. § 1983 claim for violation of the Medicaid Act’s “comparability” requirement at 42 U.S.C. § 1396a(a)(10)(B); and 3) a 42 U.S.C. § 1983 claim for violation of the Medicaid Act’s “reasonable promptness” requirement at 42 U.S.C. § 1396a(a)(8).1 The case was originally assigned to Judge Nanette Laughrey.
Plaintiffs filed their Motion for Preliminary Injunction on October 18, 2016, and briefing was completed on December 2, 2016. On December 15, 2016, Judge Laughrey held a teleconference regarding scheduling related to the Motion for Preliminary Injunction. The Minute Entry states in part:
The parties presented argument on the need for an evidentiary hearing. Defendants argued an evidentiary hearing is required for the Court to determine the community standard of care for Hepatitis C treatment. Defendants also argued for an evidentiary hearing so that they can cross-examine Plaintiffs’ experts on their opinions, which Defendants are challenging. Plaintiffs argued that no evidentiary hearing is required because all issues can be resolved on the law.
1 Defendants filed a Motion to Dismiss on January 3, 2017, arguing that Plaintiffs’ claims are not cognizable under 42 U.S.C. § 1983. The Court denied the Motion to Dismiss in a separate order.
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(Doc. #28). Also on December 15, 2016, Judge Laughrey set the motion for oral argument, and the case was transferred to the undersigned Judge. Upon transfer, oral argument was re-set to coordinate with the Court’s schedule. A motion hearing was held on January 6, 2017, during which the Court heard oral argument from both sides.
II. Legal Standard
“A plaintiff seeking a preliminary injunction must establish that (1) he is likely to succeed on the merits, (2) he is likely to suffer irreparable harm in the absence of preliminary relief, (3) the balance of equities tips in his favor, and (4) an injunction is in the public interest.” Hiltibran v. Levy, No. 10-CV-4185-NKL, 2010 WL 6825306, at *2 (W.D. Mo. Dec. 27, 2010) (citing Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 129 S.Ct. 365, 374 (2008); Dataphase Sys., Inc. v. C.L. Sys., Inc., 640 F.2d 109, 113 (8th Cir. 1981)). “An evidentiary hearing is required prior to issuing a preliminary injunction only when a material factual controversy exists.” United Healthcare Ins. Co. v. AdvancePCS, 316 F.3d 737, 744 (8th Cir. 2002) (citing Movie Sys., Inc. v. MAD Minneapolis Audio Distribs., 717 F.2d 427, 432 (8th Cir. 1983)).
III. Factual Background
Missouri participates in the federal Medicaid program and accepts federal matching funds for its program expenditures. Where a state accepts federal Medicaid funds, it must comply with federal Medicaid law. See 42 U.S.C. § 1396a. Missouri’s Medicaid program provides health services only to the “categorically needy,” including Plaintiffs. 42 U.S.C. § 1396a(a)(10)(A); Mo. Rev. Stat. § 208.151. Missouri elects to provide prescription drug benefits to participants pursuant to Mo. Rev. Stat. § 208.152(7) and 13 C.S.R. 70-20.030.
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Missouri has established a Preferred Drug List (PDL) and prior authorization program as a condition of coverage or payment for DAAs. To initiate the process, health care providers must submit a prior authorization request to MHD for DAAs for a Medicaid participant with HCV and provide sufficient information to satisfy the criteria associated with the drug requested. For all DAA requests, MO HealthNet’s Approval Criteria require “negative urine alcohol and illicit drug screen results submitted for [the] most current 3 months[.]” (Doc. #22, Ex. B). Depending on the specific drug requested and HCV genotype, MO HealthNet’s Approval Criteria require a fibrosis score of at least F2 or F3. Id. MO HealthNet’s “Denial Criteria” include: “Positive alcohol and illicit drug urine screen[;]” “Metavir fibrosis score of less than F3 for genotypes 1, 2 or 4[;]” and “Metavir fibrosis score of less than F2 for genotype 3[.]” Id. A fibrosis score, indicated by F0 through F4, represents the amount of fibrosis or scarring of the liver. F0 indicates no fibrosis while F4 represents cirrhosis.
J.E.M.’s and J.L.M.’s health care providers prescribed DAA treatments to treat and potentially cure their chronic HCV. MO HealthNet denied Plaintiffs’ requests for treatment at least in part because their fibrosis scores were lower than F3. J.E.M. received a letter stating, “MO HealthNet Division has denied the request because the information submitted did not meet the criteria established to obtain authorization for this drug.” (Doc. #2-5, p. 4).
IV. Discussion
Plaintiffs’ suit challenges MO HealthNet’s Approval Criteria based on three months of negative urine alcohol and drug screens, and fibrosis score. Plaintiffs argue the challenged criteria have no impact on the medical necessity of DAAs for HCV patients, and by applying the criteria, Mo HealthNet is failing to provide medically-necessary prescription drugs in violation of 42 U.S.C. §§ 1396a(a)(10)(A) and 1396(d)(a). Plaintiffs further argue that application of the
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challenged criteria violates the Medicaid Act’s “comparability” requirement at 42 U.S.C. § 1396a(a)(10)(B) and “reasonable promptness” requirement at 42 U.S.C. § 1396a(a)(8).
A. Negative Alcohol and Drug Screens
As stated in their proposed order submitted to the Court, Defendants agree Plaintiffs are entitled to a preliminary injunction prohibiting the application of Mo HealthNet’s Approval Criteria requiring three-months of negative alcohol and illicit drug screens before submission of a request for DAA treatment. Upon review of the parties’ filings and evidence submitted in support, as well as the oral arguments made at the January 6 hearing, the Court finds Plaintiffs have established their right to a preliminary injunction on this point. Plaintiffs have established: 1) they are likely to succeed on the merits of this issue; 2) they are likely to suffer irreparable harm in the absence of preliminary relief; 3) the balance of equities tips in their favor; and 4) an injunction is in the public interest. See Hiltibran, 2010 WL 6825306, at *2 (citations omitted). Accordingly, the Court grants Plaintiffs’ request for a preliminary injunction prohibiting Defendants from requiring three months of negative drug and alcohol screens prior to submitting requests for DAA approval.
B. Fibrosis Score
Upon review of the parties’ filings and the evidence submitted in support, the Court finds that at least two, material, factual controversies exist requiring that the Court conduct an evidentiary hearing before issuing an order on this point. First, MO HealthNet’s published Approval Criteria and corresponding Denial Criteria indicate that a health care provider’s request for DAA treatment will be denied if the HCV patient’s fibrosis score is below either F2 for genotype 3 or below F3 for genotypes 1, 2, and 4. In contrast, Defendants submitted evidence
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through affidavit testimony that some patients with fibrosis scores below the published thresholds are approved for DAA treatment based on a case-by-case review that happens in response to every DAA prior authorization request submitted by a healthcare provider. (Doc. #22, Ex. D, ¶12). MO HealthNet’s published criteria and Defendants’ stated procedures are in conflict, and the Court finds an evidentiary hearing is required on this issue.
Second, in support of their argument that an HCV patient’s fibrosis score has no impact on whether DAA treatment is medically necessary, Plaintiffs directed the Court to several pieces of persuasive evidentiary support, including: 1) their expert affidavits; 2) treatment guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America stating DAAs should not be reserved for only individuals with F3 or F4 fibrosis scores; and 3) the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services’ Medicaid Drug Rebate Program Notice: Release No. 172 criticizing some states’ practice of restricting DAA treatment based on fibrosis score. To counter Plaintiffs’ evidence that medical necessity of DAA treatment is not related to fibrosis score, Defendants submitted their own experts’ affidavits, one of whom opines, “There are many medically and clinically recognized and accepted contraindications to immediate and aggressive treatment. . . . Treating every diagnosis of HCV exposes the individual to the possibility of adverse effects or worse damage to bodily organs that may only show up years in the future.” (Doc. #22, Ex. D, ¶19). The Court finds that Defendants’ experts’ affidavits are sufficient to create a factual controversy regarding the medical necessity of DAA treatment regardless of fibrosis score, requiring a hearing.
The Court informs the parties that based on the present record, it is inclined to grant Plaintiff’s requested preliminary injunction preventing Defendants from considering an HCV
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patient’s fibrosis score in deciding whether to approve DAA treatment, particularly given that on-point, case-law precedent, although not binding on this Court, weighs in favor of the preliminary injunction. See B.E. v. Teeter, No. 16-227-JCC, 2016 WL 3033500 (W.D. Wash. May 27, 2016) (grating preliminary injunction prohibiting the Washington State Health Care Authority from considering fibrosis score in making DAA treatment decisions). However, given the Court’s inclination to grant Plaintiffs’ requested preliminary injunction on this issue as well as the fact that Defendants specifically requested an evidentiary hearing in order to be allowed an opportunity to cross-examine Plaintiffs’ experts, the Court will conduct an evidentiary hearing before issuing its ruling.
V. Conclusion
Accordingly, it is hereby ORDERED:
1) Plaintiffs’ Motion for Preliminary Injunction (Doc. #2) is granted in part; 2) The Court enters a preliminary injunction prohibiting Defendants from requiring three
months of negative drug and alcohol screens prior to submitting requests for DAA approval; 3) Defendants are directed to file a status report with the Court regarding implementation of this injunction within thirty (30) days of the date of this Order; and 4) The Court will contact the parties to schedule an evidentiary hearing regarding Plaintiffs’ request for a preliminary injunction prohibiting Defendants from considering an HCV patient’s fibrosis score in deciding whether to approve or deny a healthcare provider’s request for DAA treatment.
IT IS SO ORDERED.
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Dated: February 2, 2017

/s/ Stephen R. Bough STEPHEN R. BOUGH UNITED STATES DISTRICT JUDGE

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 U.S. District Court Western District of Missouri (Jefferson City) CIVIL DOCKET FOR CASE #: 2:16−cv−04273−SRB

CLOSED,PHV

J.E.M. et al v. Kinkade et al Assigned to: District Judge Stephen R. Bough Cause: 28:1983 Civil Rights
Plaintiff J.E.M.

Date Filed: 10/18/2016 Date Terminated: 11/20/2017 Jury Demand: Defendant Nature of Suit: 440 Civil Rights: Other Jurisdiction: Federal Question
represented by Abigail Coursolle 3701 Wilshire Blvd Suite 750 Los Angeles, CA 90010 (310) 736−1652 Email: coursolle@healthlaw.org LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED
Joel D Ferber Legal Services of Eastern Missouri, Inc. 4232 Forest Park Blvd. St. Louis, MO 63108 (314) 256−8702 Fax: (314) 534−1028 Email: jdferber@lsem.org LEAD ATTORNEY ATTORNEY TO BE NOTICED
John J. Ammann St. Louis University Legal Clinic St. Louis University School of Law 100 North Tucker St. Louis, MO 63101 (314) 977−2796 Fax: (314) 977−1180 Email: ammannjj@slu.edu LEAD ATTORNEY ATTORNEY TO BE NOTICED
Martha Jane Perkins 200 North Greensboro Street Suite D−13 Carrboro, NC 27510 (919) 968−6308 Email: perkins@healthlaw.org LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED
Jamie Rodriguez Legal Services of Eastern Missouri, Inc. − StL 4232 Forest Park Blvd. St. Louis, MO 63108 (314) 256−8773 Fax: 314−534−1028 Email: jlrodriguez@lsem.org ATTORNEY TO BE NOTICED

Plaintiff J.L.M.
Plaintiff H. L. O
V. Defendant Brian Kinkade Director TERMINATED: 02/14/2017
Defendant Joe Parks, M.D. TERMINATED: 02/14/2017

represented by Abigail Coursolle (See above for address) LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED
Joel D Ferber (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
John J. Ammann (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Martha Jane Perkins (See above for address) LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED
Jamie Rodriguez (See above for address) ATTORNEY TO BE NOTICED
represented by Abigail Coursolle (See above for address) LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED
Joel D Ferber (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
John J. Ammann (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
represented by Colleen Joern Vetter Missouri Attorney General's Office−StL 815 Olive Street Suite 200 St. Louis, MO 63101 314−340−7861 Fax: 314−340−7029 Email: colleen.vetter@ago.mo.gov TERMINATED: 09/21/2017 LEAD ATTORNEY ATTORNEY TO BE NOTICED
represented by Colleen Joern Vetter (See above for address)

Defendant Jennifer Tidball, Acting Director of Missouri Department of Social Services TERMINATED: 06/06/2017
Defendant Jay Ludlam Director of MO HealthNet Division
Defendant Steven Corsi in his official capacity as Director of the Missouri Department of Social Services

TERMINATED: 09/21/2017 LEAD ATTORNEY ATTORNEY TO BE NOTICED
represented by Colleen Joern Vetter (See above for address) TERMINATED: 09/21/2017 LEAD ATTORNEY ATTORNEY TO BE NOTICED
Dean John Sauer Missouri Attorney General's Office−JC P.O. Box 899 Jefferson City, MO 65102 573−751−8807 Fax: 573−751−2203 Email: john.sauer@ago.mo.gov LEAD ATTORNEY
Michael D. Quinlan Missouri Attorney General's Office−JC P.O. Box 899 Jefferson City, MO 65102 573−751−8833 Fax: 573−751−9456 Email: michael.quinlan@ago.mo.gov LEAD ATTORNEY ATTORNEY TO BE NOTICED
represented by Colleen Joern Vetter (See above for address) TERMINATED: 09/21/2017 LEAD ATTORNEY ATTORNEY TO BE NOTICED
Dean John Sauer (See above for address) LEAD ATTORNEY
Michael D. Quinlan (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
represented by Colleen Joern Vetter (See above for address) TERMINATED: 09/21/2017 LEAD ATTORNEY ATTORNEY TO BE NOTICED
Dean John Sauer (See above for address) LEAD ATTORNEY
Michael D. Quinlan (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

Date Filed 10/18/2016 10/18/2016
10/18/2016 10/18/2016 10/18/2016 10/18/2016
10/18/2016 10/19/2016
10/19/2016 10/19/2016 10/19/2016 10/19/2016

# Docket Text
1 COMPLAINT against defendants Kinkade and Parks filed by Joel Ferber on behalf of All Plaintiffs. Filing fee $400, receipt number 0866−5028533. Service due by 1/20/2017. (Attachments: # 1 Civil Cover Sheet Civil Cover Sheet)(Ferber, Joel) Modified on 10/18/2016 (Russel, Jeri). (Entered: 10/18/2016)
2 MOTION for preliminary injunction filed by Joel Ferber on behalf of All Plaintiffs. Suggestions in opposition/response due by 11/4/2016 unless otherwise directed by the court. (Attachments: # 1 Exhibit Plaintiff's List of Exhibits in Support of Motion for Preliminary Injunction, # 2 Exhibit Exhibit 1, # 3 Exhibit Exhibit 2, # 4 Exhibit Exhibit 3, # 5 Exhibit Exhibit 4, # 6 Exhibit Exhibit 5, # 7 Exhibit Exhibit 6, # 8 Exhibit Exhibit 7, # 9 Exhibit Exhibit 8, # 10 Exhibit Exhibit 9, # 11 Exhibit Exhibit 10, # 12 Exhibit Exhibit 11, # 13 Exhibit Exhibit 12, # 14 Exhibit Exhibit 13)(Ferber, Joel) (Entered: 10/18/2016)
3 MOTION for leave to file excess pages filed by Joel Ferber on behalf of All Plaintiffs. Suggestions in opposition/response due by 11/4/2016 unless otherwise directed by the court. (Ferber, Joel) (Entered: 10/18/2016)
4 MOTION for order to proceed with the use of initials filed by Joel Ferber on behalf of All Plaintiffs. Suggestions in opposition/response due by 11/4/2016 unless otherwise directed by the court. (Ferber, Joel) (Entered: 10/18/2016)
5 SUGGESTIONS in support re 2 MOTION for preliminary injunction filed by Joel Ferber on behalf of Plaintiffs J.E.M., J.L.M.. (Related document(s) 2 ) (Ferber, Joel) (Entered: 10/18/2016)
6 NOTICE OF INCLUSION FOR MEDIATION AND ASSESSMENT PROGRAM (MAP). REVIEW NOTICE AND MAP GENERAL ORDER CAREFULLY FOR IMPORTANT CHANGES, DEADLINES AND REQUIREMENTS.
Notice of MAP assignment to United States Magistrate Judge William A. Knox. (Attachments: # 1 MAP General Order)(Russel, Jeri) (Entered: 10/18/2016)
SUMMONS ISSUED as to Brian Kinkade, Joseph Parks. (Watson, Olivette) (Entered: 10/18/2016)
7 ORDER entered by Judge Nanette Laughrey. Plaintiffs' Motion for Leave to File Excess Pages, Doc. 3 , is granted. Plaintiffs' Suggestions in Support of their Motion for Preliminary Injunction may not exceed 25 pages. Plaintiffs' Motion for Order to Proceed with the Use of Initials, Doc. 4 , is granted. Plaintiffs may proceed in this matter with the use of their initials in order to preserve their privacy. It is further ordered that Defendants shall not publicly disclose Plaintiffs' names or personally identifying information. All parties shall file any documents with this Court redacted of Plaintiffs' names and other personally identifying information. This is a TEXT ONLY ENTRY. No document is attached.(Specker, Suzanne) (Entered: 10/19/2016)
8 Motion to allow Abigail Koelzer Coursolle to appear pro hac vice (Pro Hac fee $50 receipt number 0866−5030446) filed by Joel Ferber on behalf of All Plaintiffs. (Ferber, Joel) (Main Document 8 replaced with petition only on 10/20/2016) (Lock, Tania). (Entered: 10/19/2016)
9 Entry of Appearance filed by Jamie Rodriguez on behalf of All Plaintiffs. (Attorney Jamie Rodriguez added to party J.E.M.(pty:pla), Attorney Jamie Rodriguez added to party J.L.M.(pty:pla))(Rodriguez, Jamie) Modified on 10/19/2016 to correct event (Lock, Tania). (Entered: 10/19/2016)
10 ORDER ON PRETRIAL PROCEDURES. Service must be obtained on all defendants within forty (40) days of the date of this Order unless otherwise authorized by the Court. Signed on 10/19/16 by District Judge Nanette K. Laughrey. (Matthes Mitra, Renea) (Entered: 10/19/2016)
11 NOTICE of appearance by John J. Ammann on behalf of All Plaintiffs (Attorney John J. Ammann added to party J.E.M.(pty:pla), Attorney John J. Ammann added to party J.L.M.(pty:pla))(Ammann, John) (Entered: 10/19/2016)

10/21/2016 10/24/2016 10/24/2016 10/25/2016 10/25/2016 10/26/2016
11/02/2016 11/02/2016 11/03/2016 11/21/2016 11/21/2016 11/23/2016

12 Motion to allow Martha Jane Perkins to appear pro hac vice (Pro Hac fee $50 receipt number 0866−5033692) filed by Joel Ferber on behalf of All Plaintiffs. (Ferber, Joel) (Main Document 12 replaced with petition for pro hac only on 10/24/2016. Original ECF registration forms should be submitted by mail, not filed on ECF ) (Lock, Tania). Modified on 10/24/2016 (Lock, Tania). (Entered: 10/21/2016)
13 RETURN OF SERVICE of complaint executed by All Plaintiffs. Brian Kinkade served on 10/20/2016, answer due 11/10/2016. (Ammann, John) (Entered: 10/24/2016)
14 RETURN OF SERVICE of complaint executed by All Plaintiffs. Joe Parks, M.D. served on 10/20/2016, answer due 11/10/2016. (Ammann, John) (Entered: 10/24/2016)
15 Amended Petition for Admission Pro Hac Vice for Martha Jane Perkins filed by Joel Ferber on behalf of All Plaintiffs. Suggestions in opposition/response due by 11/14/2016 unless otherwise directed by the court. (Ferber, Joel) Modified on 10/26/2016 to correct event type (Lock, Tania). (Entered: 10/25/2016)
16 Amended Petition for Admission Pro Hac Vice for Abigail K. Coursolle filed by Joel Ferber on behalf of All Plaintiffs. Suggestions in opposition/response due by 11/14/2016 unless otherwise directed by the court. (Ferber, Joel) Modified on 10/26/2016 to correct event type (Lock, Tania). (Entered: 10/25/2016)
17 ORDER granting 15 & 16 amended motions to appear pro hac vice entered by Clerk of Court. Attorney Martha Jane Perkins and Abigail Coursolle for J.E.M. and J.L.M. allowed to appear pro hac vice. This entry will serve as authorization for the pro hac participation by the attorney.
Western District of Missouri Local Rule 5.1 requires documents to be filed electronically. If pro hac vice counsel has not already done so, counsel is directed to immediately register for a CM/ECF account. This will enable counsel to electronically file documents and receive electronic notification of filings. Please return the original completed ECF Registration Form to 80 Lafayette Street, Jefferson City, Missouri 65101.
Signed on 10/26/2016 by Clerk of Court. This is a TEXT ONLY ENTRY. No document is attached.(Lock, Tania) (Entered: 10/26/2016)
18 NOTICE of appearance by Colleen Joern Vetter on behalf of Brian Kinkade, Joe Parks, M.D. (Attorney Colleen Joern Vetter added to party Brian Kinkade(pty:dft), Attorney Colleen Joern Vetter added to party Joe Parks, M.D.(pty:dft))(Vetter, Colleen) (Entered: 11/02/2016)
19 MOTION for extension of time to Respond to Plaintiffs' Motion for Preliminary Injunction and to File a Responsive Pleading filed by Colleen Joern Vetter on behalf of Brian Kinkade, Joe Parks, M.D.. Suggestions in opposition/response due by 11/21/2016 unless otherwise directed by the court. (Vetter, Colleen) (Entered: 11/02/2016)
20 ORDER entered by Judge Nanette Laughrey. Defendants' Motion for Extension of Time, Doc. 19 , is granted. Defendants' responses to Plaintiffs' Motion for Preliminary Injunction, Doc. 2 , are due on or before 11/21/2016. Defendants' responses to Plaintiffs' Complaint, Doc. 1 , are due on or before 1/2/2017. This is a TEXT ONLY ENTRY. No document is attached.(Specker, Suzanne) (Entered: 11/03/2016)
21 MOTION for leave to file excess pages filed by Colleen Joern Vetter on behalf of Brian Kinkade, Joe Parks, M.D.. Suggestions in opposition/response due by 12/8/2016 unless otherwise directed by the court. (Vetter, Colleen) (Entered: 11/21/2016)
22 SUGGESTIONS in opposition re 2 MOTION for preliminary injunction filed by Colleen Joern Vetter on behalf of Defendants Brian Kinkade, Joe Parks, M.D.. Reply suggestions due by 12/8/2016 unless otherwise directed by the court (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H)(Related document(s) 2 ) (Vetter, Colleen) (Entered: 11/21/2016)
23 ORDER entered by Judge Nanette Laughrey. Defendants' motion for leave to file excess pages, Doc. 21 , is granted. Defendants' response to Plaintiffs' motion for preliminary injunction may not exceed 25 pages.This is a TEXT ONLY ENTRY. No

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document is attached.(Specker, Suzanne) (Entered: 11/23/2016)
24 REPLY SUGGESTIONS to motion re 2 MOTION for preliminary injunction filed by Joel Ferber on behalf of Plaintiffs J.E.M., J.L.M.. (Related document(s) 2 ) (Ferber, Joel) (Entered: 12/02/2016)
25 ORDER. A Telephone Conference set for 12/13/2016 at 04:00 PM concerning scheduling related to Plaintiffs' motion for preliminary injunction, Doc. 2 . The parties shall call conference number: 877−336−1828, access code: 8503666 to participate. Signed on 12/13/16 by District Judge Nanette K. Laughrey. This is a TEXT ONLY ENTRY. No document is attached. (Matthes Mitra, Renea) (Entered: 12/13/2016)
26 AMENDED ORDER. The teleconference conference previously set for 12/13/2016 is RESET for 12/14/2016 at 11:00 AM concerning scheduling related to Plaintiffs' motion for preliminary injunction, Doc. 2. The parties shall call conference number: 877−336−1828, access code: 8503666 to participate. Signed on 12/13/16 by District Judge Nanette K. Laughrey. This is a TEXT ONLY ENTRY. No document is attached. (Matthes Mitra, Renea) Modified on 12/13/2016 to correct the date of the teleconference (Matthes Mitra, Renea). (Entered: 12/13/2016)
27 SECOND AMENDED ORDER. The teleconference conference previously set for 12/14/2016 is RESET for 12/15/2016 at 9:00 AM concerning scheduling related to Plaintiffs' motion for preliminary injunction, Doc. 2. The parties shall call conference number: 877−336−1828, access code: 8503666 to participate. Signed on 12/13/16 by District Judge Nanette K. Laughrey. This is a TEXT ONLY ENTRY. No document is attached. (Matthes Mitra, Renea) (Entered: 12/13/2016)
28 MINUTE ENTRY. Teleconference held before the Hon. Nanette K. Laughrey on 12/15/2016 about scheduling related to Plaintiffs' motion for preliminary injunction. Oral argument on the motion for preliminary injunction is set for 12/30/2016 at 11:00 a.m. by phone. The Court took under advisement whether an evidentiary hearing is needed. The parties presented argument on the need for an evidentiary hearing. Defendants argued an evidentiary hearing is required for the Court to determine the community standard of care for Hepatitis C treatment. Defendants also argued for an evidentiary hearing so that they can cross−examine Plaintiffs' experts on their opinions, which Defendants are challenging. Plaintiffs argued that no evidentiary hearing is required because all issues can be resolved on the law. Appearances: Plaintiffs by Joel Ferber, Abigail Coursolle, and John Ammann. Defendants by Colleen Joern Vetter. Court Reporter: None. Minutes prepared by Suzanne Specker. (Text entry only.) (Specker, Suzanne) (Entered: 12/15/2016)
29 ORDER. Oral Argument on Plaintiffs' Motion for Preliminary Injunction, Doc. 2 , will be presented by Telephone Conference on 12/30/2016 at 11:00 AM. The parties shall call conference number: 877−336−1828, access code: 8503666 to participate. Signed on 12/15/16 by District Judge Nanette K. Laughrey. This is a TEXT ONLY ENTRY. No document is attached. (Matthes Mitra, Renea) (Entered: 12/15/2016)
30 ORDER entered by Judge Nanette Laughrey. This case is transferred to the Hon. Stephen R. Bough, with his consent. The Clerk of Court is directed to reassign this case to Judge Bough.This is a TEXT ONLY ENTRY. No document is attached. (Specker, Suzanne) (Entered: 12/15/2016)
31 ORDER TRANSFERRING CASE. Case reassigned to District Judge Stephen R. Bough for all further proceedings. District Judge Nanette K. Laughrey no longer assigned to case. Please make a note of the new case number: 16−04273−CV−C−SRB. Signed on 12/15/16 by Clerk of the Court. This is a TEXT ONLY ENTRY. No document is attached. (Diefenbach, Tracy) Modified on 12/15/2016 to correct transferring signature. Notice regenerated. (Diefenbach, Tracy). (Entered: 12/15/2016)
32 ORDER setting hearing on motion 2 MOTION for preliminary injunction Hearing set for 1/6/2017 01:30 PM in Courtroom 7B, Kansas City (SRB) before District Judge Stephen R. Bough. Telephone Conference set for 12/30/16 at 11:00 a.m. is cancelled. Signed on 12/16/16 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached. (Diefenbach, Tracy) (Entered: 12/16/2016)
33 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by Colleen Joern Vetter on behalf of Brian Kinkade, Joe Parks, M.D.. Suggestions in

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opposition/response due by 1/17/2017 unless service is made pursuant to FRCP 5 or as otherwise directed by the court. (Vetter, Colleen) (Entered: 01/03/2017)
34 SUGGESTIONS in support re 33 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by Colleen Joern Vetter on behalf of Defendants Brian Kinkade, Joe Parks, M.D.. (Related document(s) 33 ) (Vetter, Colleen) (Entered: 01/03/2017)
35 Minute Entry. Proceedings held before District Judge Stephen R. Bough: MOTION HEARING held on 1/6/2017 re 2 MOTION for preliminary injunction filed by J.E.M., J.L.M.. Court hears argument. Matter taken under advisement. Order to be entered. Counsel appearing for Plaintiff(s): Abigail Coursolle, Joel Ferber, John Ammann, Jamie Rodriguez. Counsel appearing for Defendant(s): Colleen Joern Vetter. Time in court: 1:30 pm to 3:05 pm. To order a transcript of this hearing please contact Gayle Wambolt, 816−512−5641. This is a TEXT ONLY ENTRY. No document is attached. (Diefenbach, Tracy) (Entered: 01/06/2017)
36 RULE 16 NOTICE. Proposed scheduling order due by 2/24/2017. Scheduling Conference set for 3/10/2017 09:00 AM via telephone conference before District Judge Stephen R. Bough. Conference call information emailed to counsel. Signed on 1/12/17 by District Judge Stephen R. Bough. (Diefenbach, Tracy) (Entered: 01/12/2017)
37 SUGGESTIONS in opposition re 33 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M.. Reply suggestions due by 1/27/2017 unless otherwise directed by the court. (Related document(s) 33 ) (Ammann, John) (Entered: 01/13/2017)
38 REPLY SUGGESTIONS to motion re 33 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by Colleen Joern Vetter on behalf of Defendants Brian Kinkade, Joe Parks, M.D.. (Related document(s) 33 ) (Vetter, Colleen) (Entered: 01/27/2017)
39 NOTICE OF INCLUSION FOR MEDIATION AND ASSESSMENT PROGRAM (MAP). REVIEW NOTICE AND MAP GENERAL ORDER CAREFULLY FOR IMPORTANT CHANGES, DEADLINES AND REQUIREMENTS.
Notice of MAP assignment to an outside mediator−MU. (Geiser, Angel) (Additional attachment(s) added on 1/30/2017: # 1 MAP General Order) (Geiser, Angel). (Entered: 01/30/2017)
40 ORDERED: 1) Plaintiffs' Motion for Preliminary Injunction (Doc. #2) is granted in part; 2) The Court enters a preliminary injunction prohibiting Defendants from requiring three months of negative drug and alcohol screens prior to submitting requests for DAA approval; 3) Defendants are directed to file a status report with the Court regarding implementation of this injunction within thirty (30) days of the date of this Order; and 4) The Court will contact the parties to schedule an evidentiary hearing regarding Plaintiffs request for a preliminary injunction prohibiting Defendants from considering an HCV patients fibrosis score in deciding whether to approve or deny a healthcare providers request for DAA treatment. Signed on 2/2/17 by District Judge Stephen R. Bough. (Diefenbach, Tracy) (Entered: 02/02/2017)
41 ORDERED that Defendants' Motion to Dismiss (Doc. #33) is DENIED. Signed on 2/2/17 by District Judge Stephen R. Bough. (Diefenbach, Tracy) (Entered: 02/02/2017)
42 NOTICE OF HEARING − This is the official notice for this hearing. This is a TEXT ONLY ENTRY. No document is attached. Evidentiary Hearing set for 3/10/2017 01:30 PM in Courtroom 7B, Kansas City (SRB) before District Judge Stephen R. Bough. Scheduling Conference set for 3/10/17 at 9:00 a.m. is reset for 3/10/2017 01:30 PM in Courtroom 7B, Kansas City (SRB) before District Judge Stephen R. Bough. (Diefenbach, Tracy) (Entered: 02/09/2017)
43 MOTION to substitute party filed by Colleen Joern Vetter on behalf of Brian Kinkade, Joe Parks, M.D.. Suggestions in opposition/response due by 2/28/2017 unless otherwise directed by the court. (Vetter, Colleen) (Entered: 02/14/2017)

02/14/2017
02/15/2017 02/16/2017 02/17/2017
02/21/2017 02/22/2017 02/24/2017 03/03/2017 03/03/2017 03/06/2017 03/10/2017

44 Before the Court is Defendants' Motion for Substitution of Parties. (Doc. #43). For good cause stated the motion is GRANTED. Jennifer Tidball as the Acting Director of Missouri Department of Social Services is hereby substituted for Defendant Brian Kinkade, and Jay Ludlam as the Acting Director of MO HealthNet Division is hereby substituted for Defendant Joe Parks, M.D. Signed on 2/14/17 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached.(Diefenbach, Tracy) (Entered: 02/14/2017)
45 MOTION for extension of time to file answer re 1 Complaint, filed by Colleen Joern Vetter on behalf of Jay Ludlam, Acting Director of MO HealthNet Division, Jennifer Tidball, Acting Director of Missouri Department of Social Services. Suggestions in opposition/response due by 3/1/2017 unless otherwise directed by the court. (Related document(s) 1 ) (Vetter, Colleen) (Entered: 02/15/2017)
46 ORDER: Before the Court is Defendants' Motion for Extension of time to Answer Plaintiffs' Complaint (Doc. #45). For good cause shown, the motion is granted. Defendants shall file an answer or other responsive pleading on or before February 21, 2017. Signed on 2/16/2017 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached.(Travis, Kendra) (Entered: 02/16/2017)
47 ELECTRONIC TRANSCRIPT of Oral Arguments held January 6, 2017, before Judge Stephen R. Bough. Court Reporter: Gayle Wambolt, 816−512−5641, gayle_wambolt@mow.uscourts.gov. Number of pages: 68. NOTICE RE: REDACTION OF TRANSCRIPTS: Within 7 calendar days of this filing, each party shall inform the Court, by filing a Notice of Redaction, of the parties' intent to redact personal data identifiers from the electronic transcript of the court proceeding. The policy is located on our website at www.mow.uscourts.gov. Please read this policy carefully. NOTICE: Attorneys must contact the court reporter for copies during this 90 day period. Notice of Intent to File Redaction of Transcripts due by 2/24/2017 unless otherwise directed by the court. Release of Transcript Restriction set for 5/15/2017.(Wambolt, Gayle) (Entered: 02/17/2017)
48 ANSWER to 1 Complaint, with Jury Demand on behalf of Jay Ludlam, Acting Director of MO HealthNet Division, Jennifer Tidball, Acting Director of Missouri Department of Social Services.(Vetter, Colleen) (Entered: 02/21/2017)
49 NOTICE of appearance by Dean John Sauer on behalf of Jay Ludlam, Acting Director of MO HealthNet Division, Jennifer Tidball, Acting Director of Missouri Department of Social Services (Attorney Dean John Sauer added to party Jay Ludlam, Acting Director of MO HealthNet Division(pty:dft), Attorney Dean John Sauer added to party Jennifer Tidball, Acting Director of Missouri Department of Social Services(pty:dft))(Sauer, Dean) (Entered: 02/22/2017)
50 REPORT of Rule 26(f) planning meeting. (Ammann, John) (Main Document 50 replaced on 2/27/2017) (Geiser, Angel). (Entered: 02/24/2017)
51 STATUS REPORT by Jay Ludlam, Acting Director of MO HealthNet Division, Jennifer Tidball, Acting Director of Missouri Department of Social Services. (Attachments: # 1 Exhibit A)(Vetter, Colleen) Modified on 3/6/2017 at the request of counsel attachment 1 replaced with revised exhibit only. NEF regenerated to all parties.(Travis, Kendra) (Entered: 03/03/2017)
52 MOTION for extension of time for Evidentiary Hearing filed by Colleen Joern Vetter on behalf of Jay Ludlam, Acting Director of MO HealthNet Division, Jennifer Tidball, Acting Director of Missouri Department of Social Services. Suggestions in opposition/response due by 3/17/2017 unless otherwise directed by the court. (Attachments: # 1 Exhibit A, # 2 Exhibit B)(Vetter, Colleen) (Entered: 03/03/2017)
53 Before the Court is Defendants' Motion to Expand Time for Evidentiary Hearing. (Doc. #52). The motion is granted in part. The Court will allow one additional hour for the March 10, 2017, hearing for a total hearing time of three hours. The hearing will begin at 1:00 p.m., thirty minutes earlier than originally scheduled in Courtroom 7B, Kansas City. Signed on 3/6/17 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached.(Diefenbach, Tracy) (Entered: 03/06/2017)
54 Minute Entry. Proceedings held before District Judge Stephen R. Bough: EVIDENTIARY HEARING held on 3/10/2017. Time in court: 1:15 p.m. to 4:45 p.m.. To order a transcript of this hearing please contact Reggie Lambrecht, 816−512−5623.

03/13/2017 03/13/2017 03/17/2017 03/20/2017 03/29/2017
04/05/2017 04/24/2017 04/24/2017
04/25/2017 04/25/2017
05/15/2017 05/19/2017

(Diefenbach, Tracy) (Entered: 03/10/2017)
55 NOTICE of filing Evidentiary Hearing Exhibits by Jay Ludlam, Acting Director of MO HealthNet Division, Jennifer Tidball, Acting Director of Missouri Department of Social Services (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C)(Vetter, Colleen) (Entered: 03/13/2017)
56 NOTICE of filing of Exhibits by J.E.M., J.L.M. (Attachments: # 1 Exhibit 14, # 2 Exhibit 15, # 3 Exhibit 16, # 4 Exhibit 17, # 5 Exhibit 18, # 6 Exhibit 19, # 7 Exhibit 20, # 8 Exhibit 21, # 9 Exhibit 22, # 10 Exhibit 23a, # 11 Exhibit 23b)(Ammann, John) (Entered: 03/13/2017)
57 NOTICE of filing Evidentiary Hearing Exhibit by Jay Ludlam, Acting Director of MO HealthNet Division, Jennifer Tidball, Acting Director of Missouri Department of Social Services (Attachments: # 1 Exhibit D)(Vetter, Colleen) (Entered: 03/17/2017)
58 NOTICE of filing by J.E.M. (Attachments: # 1 Exhibit, # 2 attachment, # 3 attachment, # 4 attachment, # 5 attachment, # 6 attachment, # 7 attachment)(Ferber, Joel) (Entered: 03/20/2017)
59 ELECTRONIC TRANSCRIPT of Evidentiary Hearing held March 10, 2017 before Judge Stephen R. Bough. Court Reporter: Reggie Lambrecht, 816−512−5623, regina_lambrecht@mow.uscourts.gov. Number of pages: 158. NOTICE RE: REDACTION OF TRANSCRIPTS: Within 7 calendar days of this filing, each party shall inform the Court, by filing a Notice of Redaction, of the parties' intent to redact personal data identifiers from the electronic transcript of the court proceeding. The policy is located on our website at www.mow.uscourts.gov. Please read this policy carefully. NOTICE: Attorneys must contact the court reporter for copies during this 90 day period. Notice of Intent to File Redaction of Transcripts due by 4/5/2017 unless otherwise directed by the court. Release of Transcript Restriction set for 6/26/2017.(Lambrecht, Regina) (Entered: 03/29/2017)
60 DESIGNATION OF MEDIATOR naming James Levin(Ammann, John) (Entered: 04/05/2017)
61 ORDER: Plaintiffs Motion for a Preliminary Injunction (Doc. #2) asking the Court to enjoin Defendants from considering Missouri Medicaid beneficiaries fibrosis scores in deciding whether to approve DAA treatments, is denied. Signed on 4/24/17 by District Judge Stephen R. Bough. (Diefenbach, Tracy) Modified on 4/24/2017 to unseal as directed in Document 62. (Diefenbach, Tracy). (Entered: 04/24/2017)
62 ORDER: On April 24, 2017, the Court entered an order denying the remaining portion of Plaintiffs' Motion for Preliminary Injunction. (Doc. #61). The Order was filed under seal in error. Therefore, the Court hereby directs the Clerk of the Court to unseal the April 24 Order. Signed on 4/24/17 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached. (Diefenbach, Tracy) (Entered: 04/24/2017)
63 RULES OF TRIAL Signed on 4/25/17 by District Judge Stephen R. Bough. (Diefenbach, Tracy) (Entered: 04/25/2017)
64 SCHEDULING ORDER: Discovery due by 8/22/2017. Dispositive Motions due by 10/23/2017. Pretrial Conference set for 1/26/2018 10:00 AM Courtroom 7B, Kansas City (SRB) before District Judge Stephen R. Bough. Bench Trial set for 2/5/2018 09:00 AM in Courtroom 7B, Kansas City (SRB) before District Judge Stephen R. Bough. Dispositive Motions due by 10/23/2017. Signed on 4/25/17 by District Judge Stephen R. Bough. (Diefenbach, Tracy) (Entered: 04/25/2017)
65 CERTIFICATE OF SERVICE OF INITIAL RULE 26 DISCLOSURES filed by Colleen Joern Vetter on behalf of Defendants Jay Ludlam, Acting Director of MO HealthNet Division, Jennifer Tidball, Acting Director of Missouri Department of Social Services.(Vetter, Colleen) (Entered: 05/15/2017)
66 CERTIFICATE OF SERVICE OF INITIAL RULE 26 DISCLOSURES filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M..(Ammann, John) (Entered: 05/19/2017)

06/03/2017 06/03/2017 06/05/2017 06/06/2017
06/06/2017 06/14/2017 06/15/2017
06/20/2017 06/20/2017
06/21/2017 06/23/2017 06/29/2017 06/30/2017 06/30/2017 06/30/2017 06/30/2017

67 MOTION to amend/correct Complaint filed by Joel D Ferber on behalf of All Plaintiffs. Suggestions in opposition/response due by 6/19/2017 unless otherwise directed by the court. (Attachments: # 1 Exhibit Proposed Amended Complaint)(Ferber, Joel) (Entered: 06/03/2017)
68 SUGGESTIONS in support re 67 MOTION to amend/correct Complaint filed by Joel D Ferber on behalf of Plaintiffs J.E.M., J.L.M.. (Related document(s) 67 ) (Ferber, Joel) (Entered: 06/03/2017)
69 CERTIFICATE OF SERVICE by All Plaintiffs filed by Joel D Ferber on behalf of Plaintiffs J.E.M., J.L.M..(Ferber, Joel) (Entered: 06/05/2017)
70 Before the Court is Motion for Leave to File an Amended Complaint. (Doc. #67). Pursuant to Federal Rule of Civil Procedure 15 and considering the lack of opposition by Defendants, the motion is granted. Plaintiffs are directed to file their First Amended Complaint on or before June 7, 2017. Signed on 6/6/17 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached.(Diefenbach, Tracy) (Entered: 06/06/2017)
71 AMENDED COMPLAINT against All Defendants filed by Joel D Ferber on behalf of All Plaintiffs.(Ferber, Joel) (Entered: 06/06/2017)
72 Consent MOTION for leave to file excess pages filed by Colleen Joern Vetter on behalf of All Defendants. Suggestions in opposition/response due by 6/28/2017 unless otherwise directed by the court. (Vetter, Colleen) (Entered: 06/14/2017)
73 ORDER: Before the Court is Defendants' Motion to Exceed Page Limits on Motion to Dismiss. (Doc. #72). For good cause stated the motion is granted. Defendants are granted leave to file a motion to dismiss in a length up to twenty (20) pages. Signed on 6/15/2017 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached.(Travis, Kendra) (Entered: 06/15/2017)
74 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by Colleen Joern Vetter on behalf of All Defendants. Suggestions in opposition/response due by 7/5/2017 unless otherwise directed by the court. (Vetter, Colleen) (Entered: 06/20/2017)
75 SUGGESTIONS in support re 74 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Brian Kinkade, Jay Ludlam, Joe Parks, M.D., Jennifer Tidball, Acting Director of Missouri Department of Social Services. (Related document(s) 74 ) (Vetter, Colleen) (Entered: 06/20/2017)
76 CERTIFICATE OF SERVICE by All Plaintiffs of Plaintiffs' Designation of Experts filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 06/21/2017)
77 CERTIFICATE OF SERVICE by All Defendants filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Brian Kinkade, Jay Ludlam, Joe Parks, M.D., Jennifer Tidball, Acting Director of Missouri Department of Social Services.(Vetter, Colleen) (Entered: 06/23/2017)
78 NOTICE of appearance by Michael D. Quinlan on behalf of Steven Corsi, Jay Ludlam (Attorney Michael D. Quinlan added to party Steven Corsi(pty:dft), Attorney Michael D. Quinlan added to party Jay Ludlam(pty:dft))(Quinlan, Michael) (Entered: 06/29/2017)
79 NOTICE to take deposition of Jay Ludlam filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 06/30/2017)
80 NOTICE to take deposition of Jennifer Tidball filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 06/30/2017)
81 NOTICE to take deposition of Stephen Calloway filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 06/30/2017)
82 NOTICE to take deposition of Mark Roaseau filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 06/30/2017)

06/30/2017 07/03/2017
07/07/2017
07/07/2017
07/12/2017 07/12/2017 07/12/2017 07/12/2017 07/17/2017
07/18/2017 07/18/2017 07/21/2017 07/21/2017 07/24/2017
08/02/2017 08/02/2017 08/02/2017 08/02/2017

83 CERTIFICATE OF SERVICE by All Plaintiffs filed by Joel D Ferber on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ferber, Joel) (Entered: 06/30/2017)
84 SUGGESTIONS in opposition re 74 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by Abigail Coursolle on behalf of Plaintiffs J.E.M., J.L.M., H. L. O. Reply suggestions due by 7/17/2017 unless otherwise directed by the court. (Related document(s) 74 ) (Coursolle, Abigail) (Entered: 07/03/2017)
85 CERTIFICATE OF SERVICE by Steven Corsi, Jay Ludlam Objections and Responses to Plaintiff's First Request for Production of Documents filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/07/2017)
86 CERTIFICATE OF SERVICE by Steven Corsi, Jay Ludlam First Supplemental Objections and Responses to Plaintiffs' First Request for Production of Documents filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/07/2017)
87 NOTICE to take deposition of Dr. Blair Thedinger filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/12/2017)
88 NOTICE to take deposition of J.L.M. filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/12/2017)
89 NOTICE to take deposition of J.E.M. filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/12/2017)
90 NOTICE to take deposition of H.L.O. filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/12/2017)
91 REPLY SUGGESTIONS to motion re 74 MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Brian Kinkade, Jay Ludlam, Joe Parks, M.D., Jennifer Tidball, Acting Director of Missouri Department of Social Services. (Related document(s) 74 ) (Vetter, Colleen) (Entered: 07/17/2017)
92 NOTICE to take deposition of Dr. Bruce R. Bacon filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/18/2017)
93 NOTICE to take deposition of Dr. Jaquelyn Fitch Fleckenstein filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/18/2017)
94 ORDER: Defendants Motion to Dismiss Plaintiffs Amended Complaint (Doc. #74) is hereby DENIED. Signed on 7/21/2017 by District Judge Stephen R. Bough. (Travis, Kendra) (Entered: 07/21/2017)
95 CERTIFICATE OF SERVICE by All Plaintiffs filed by Joel D Ferber on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ferber, Joel) (Entered: 07/21/2017)
96 CERTIFICATE OF SERVICE by Steven Corsi, Jay Ludlam Defendants' First Supplemental Disclosures and Expert Witness Disclosure filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 07/24/2017)
97 Amended NOTICE to take deposition of Jay Ludlam filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 08/02/2017)
98 Amended NOTICE to take deposition of Steve Calloway filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 08/02/2017)
99 Amended NOTICE to take deposition of Mark Roaseau filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 08/02/2017)
100 Amended NOTICE to take deposition of Jennifer Tidball filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 08/02/2017)

08/03/2017
08/04/2017
08/04/2017 08/08/2017 08/09/2017 08/09/2017 08/09/2017
08/19/2017 08/19/2017 08/30/2017 09/08/2017 09/21/2017 09/21/2017
10/19/2017 10/19/2017

101 Consent MOTION for protective order filed by Colleen Joern Vetter on behalf of Steven Corsi, Jay Ludlam. Suggestions in opposition/response due by 8/17/2017 unless otherwise directed by the court. (Attachments: # 1 Exhibit A deleted per administrative orders in regards to proposed orders )(Vetter, Colleen) (Entered: 08/03/2017)
NOTICE OF DOCKET MODIFICATION. A modification has been made to the document filed on 08/03/2017 as Document No. 101−1, Exhibit. The proposed order attached to the motion has been deleted. Per Administrative Procedures any proposed orders are to be emailed to the Courtroom Deputy in Word format. This is a text entry only − no document is attached. (Geiser, Angel) (Entered: 08/04/2017)
102 PROTECTIVE ORDER Signed on 8/4/17 by District Judge Stephen R. Bough. (Diefenbach, Tracy) (Entered: 08/04/2017)
103 NOTICE of filing Notice of Deposition by Steven Corsi, Jay Ludlam (Vetter, Colleen) (Entered: 08/08/2017)
104 NOTICE to take deposition of Kevin Costello filed by Colleen Joern Vetter on behalf of Defendants Steven Corsi, Jay Ludlam.(Vetter, Colleen) (Entered: 08/09/2017)
105 MOTION for extension of time to complete discovery for Purpose of Taking Depositions filed by Colleen Joern Vetter on behalf of Steven Corsi, Jay Ludlam. Suggestions in opposition/response due by 8/23/2017 unless otherwise directed by the court. (Vetter, Colleen) (Entered: 08/09/2017)
106 Before the Court is Consent Motion to Extend Discovery Deadline for Purpose of Taking Depositions. (Doc. #105). For good cause stated the motion is granted. The current discovery deadline of August 22, 2017, is extended until and including August 31, 2017. All other deadlines set by the Scheduling Order remain unchanged. Signed on 8/9/17 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached.(Diefenbach, Tracy) (Entered: 08/09/2017)
107 NOTICE to take deposition of Dr. Ronald Koretz filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 08/19/2017)
108 Amended NOTICE to take deposition of Dr. Ronald Koretz filed by John J. Ammann on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ammann, John) (Entered: 08/19/2017)
109 CERTIFICATE OF SERVICE by All Plaintiffs filed by Joel D Ferber on behalf of Plaintiffs J.E.M., J.L.M., H. L. O.(Ferber, Joel) (Entered: 08/30/2017)
110 Defendants' ANSWER to 71 Amended Complaint on behalf of Steven Corsi, Jay Ludlam.(Quinlan, Michael) (Entered: 09/08/2017)
111 MOTION to withdraw as attorney filed by Colleen Joern Vetter on behalf of Steven Corsi, Jay Ludlam. Suggestions in opposition/response due by 10/5/2017 unless otherwise directed by the court. (Vetter, Colleen) (Entered: 09/21/2017)
112 Before the Court is Motion to Withdraw. (Doc. #111). For good cause stated the motion is granted. Attorney Colleen Joern Vetter is hereby removed as co−counsel of record for Defendants Steven Corsi and Jay Ludlam. Defendants Corsi and Ludlam will continue to be represented by attorneys Dean Sauer and Michael Quinlan of the Missouri Attorney Generals Office. Signed on 9/21/17 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached.(Diefenbach, Tracy) (Entered: 09/21/2017)
113 Consent MOTION for extension of time to File Dispositive Motions filed by Michael D. Quinlan on behalf of Steven Corsi, Jay Ludlam. Suggestions in opposition/response due by 11/2/2017 unless otherwise directed by the court. (Quinlan, Michael) (Entered: 10/19/2017)
114 Before the Court is Consent Motion to Extend Deadline for the Filing of Dispositive Motions. (Doc. #113). For good cause stated the motion is granted. The parties are granted an extension of time until and including November 2, 2017, to file dispositive motions. Signed on 10/19/17 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached.(Diefenbach, Tracy) (Entered: 10/19/2017)

11/01/2017 11/02/2017 11/02/2017
11/07/2017 11/20/2017 11/20/2017

115 CERTIFICATE OF SERVICE by Steven Corsi, Jay Ludlam filed by Michael D. Quinlan on behalf of Defendants Steven Corsi, Jay Ludlam.(Quinlan, Michael) (Entered: 11/01/2017)
116 MOTION for summary judgment filed by Michael D. Quinlan on behalf of Steven Corsi, Jennifer Tidball, Acting Director of Missouri Department of Social Services. Suggestions in opposition/response due by 11/24/2017 unless otherwise directed by the court. (Attorney Michael D. Quinlan added to party Jennifer Tidball, Acting Director of Missouri Department of Social Services(pty:dft))(Quinlan, Michael) (Entered: 11/02/2017)
117 MOTION for summary judgment Suggestions in Support and Statement of Uncontroverted Material Facts filed by Michael D. Quinlan on behalf of Steven Corsi, Jennifer Tidball, Acting Director of Missouri Department of Social Services. Suggestions in opposition/response due by 11/24/2017 unless otherwise directed by the court. (Attachments: # 1 Exhibit Ex A − Steve Calloway Declaration, # 2 Exhibit Ex A1, # 3 Exhibit Ex A2, # 4 Exhibit Ex A3, # 5 Exhibit Ex A4, # 6 Exhibit Ex A5, # 7 Exhibit Ex B − Mark Roaseau Declaration, # 8 Exhibit Ex B1, # 9 Exhibit Ex B2, # 10 Exhibit Ex B3, # 11 Exhibit Ex B4, # 12 Exhibit Ex B5, # 13 Exhibit Ex B6, # 14 Exhibit Ex B7, # 15 Exhibit Ex C − Dr Bacon Testimony, # 16 Exhibit Dc D − Mark Roaseau Deposition)(Quinlan, Michael) (Entered: 11/02/2017)
118 CERTIFICATE OF SERVICE by Steven Corsi, Jay Ludlam of Fourth Sup Rsp to Ps RFP and Third Sup Disclosures filed by Michael D. Quinlan on behalf of Defendants Steven Corsi, Jay Ludlam.(Quinlan, Michael) (Entered: 11/07/2017)
119 MOTION to dismiss case filed by Abigail Coursolle on behalf of All Plaintiffs. Suggestions in opposition/response due by 12/4/2017 unless otherwise directed by the court. (Coursolle, Abigail) (Entered: 11/20/2017)
120 Before the Court is Plaintiffs' Motion to Dismiss Without Prejudice. (Doc. #119). The motion is granted, and this case is dismissed without prejudice with each party to bear its own costs and fees. Further, the pending motions (Doc. ##116, 117) are denied as moot. Signed on 11/20/17 by District Judge Stephen R. Bough. This is a TEXT ONLY ENTRY. No document is attached. (Diefenbach, Tracy) (Entered: 11/20/2017)

 
 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF MISSOURI
CENTRAL DIVISION

J.E.M., J.L.M.

)

Plaintiffs,

)

)

v.

)

)

)

BRIAN KINKADE, in his official capacity )

as Director of the Missouri Department of )

Social Services; and

)

JOE PARKS, M.D., in his official

)

capacity as Director of the MO HealthNet )

Division,

)

)

Defendants.

)

Case No. 2:16-cv-04273

COMPLAINT ________________________________________________________________________
I. PRELIMINARY STATEMENT 1. This case challenges the policies of the Missouri Department of Social Services which result in the denial of medically necessary treatment for Plaintiffs J.E.M., J.L.M., and numerous other Medicaid beneficiaries infected with the Hepatitis C virus (HCV), a serious and communicable disease that can cause severe liver scarring, liver damage, cancer, and death. 2. This case is filed on behalf of enrollees in the Missouri Medicaid program, also known as MO HealthNet, who are infected with HCV, who meet the FDA’s standards for coverage of curative Hepatitis C medication, but who are denied coverage for medically necessary treatment because of the Defendants’ arbitrary and improper policies that restrict treatment only to the sickest beneficiaries. Without this treatment, damage to enrollees’ livers grows more severe and the risk of complications from the disease increases.

Case 2:16-cv-04273-SRB Document 1 Filed 10/18/16 Page 1 of 19

II. JURISDICTION AND VENUE

3. This action arises under Title XIX of the Social Security Act. The Court has

jurisdiction pursuant to 28 U.S.C. § 1331, which gives district courts original jurisdiction over all

civil actions arising under the Constitution, laws, or treaties of the United States, and 28 U.S.C.

§§ 1343(a)(3) and (4), which give district courts original jurisdiction over suits to redress the

deprivation under color of state law of any rights, privileges, or immunities guaranteed by the

Constitution or acts of Congress.

4. This Court has jurisdiction over this action for declaratory relief pursuant to 28

U.S.C. § 2201 and Rule 57 of the Federal Rules of Civil Procedure. Injunctive relief is

authorized by 28 U.S.C. § 2202, 42 U.S.C. § 1983, and Rule 65 of the Federal Rules of Civil

Procedure.

5. Venue is proper under 28 U.S.C. § 1391(b).

III.

PARTIES

Plaintiffs

6. Plaintiff J.E.M. is a 45-year-old Medicaid recipient living alone in Imperial,

Missouri. He suffers from a variety of medical conditions, including Hepatitis C, pancreatitis,

spinal osteoarthritis, and high blood pressure. Because of his Hepatitis C, J.E.M. has experienced

a significant decrease in energy and motivation. He also experiences anxiety regarding his

disease’s progress and the potential fatal effect of the infection, which recently took the life of

his father. His doctor has prescribed Harvoni®, ledipasvir-sofosbuvir (“Harvoni”), a drug that

will likely cure his Hepatitis C. MO HealthNet denied his prior authorization request for

Harvoni.

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7. Plaintiff J.L.M. is a 36-year-old Medicaid recipient living with her two teenage daughters in Foley, Missouri. She has Hepatitis C and also fibromyalgia. Because of her Hepatitis C, J.L.M.’s underlying fibromyalgia pain and fatigue has worsened. She also experiences continual anxiety and fear that she may inadvertently infect her children. Her doctor has prescribed Epclusa®, sofosbuvir-velpatasvir (“Epclusa”), a drug which will likely cure her Hepatitis C. MO HealthNet denied her prior authorization request for Epclusa.
Defendants 8. Defendant Brian Kinkade is the Director of the Missouri Department of Social Services (“DSS”) and, as such, is responsible for the administration and implementation of laws concerning the social welfare of the people of the State of Missouri, including the Medicaid program. Defendant Kinkade is the chief administrative officer of DSS and is responsible for administration of the single state agency for the Missouri Medicaid program. Defendant Kinkade is charged with the ultimate control and administration of DSS, including the duty to administer the Missouri Medicaid program in compliance with the Medicaid Act. He is sued in his official capacity. His principal office is located in Jefferson City, Missouri. 9. Defendant Joe Parks, M.D., is the Director of MO HealthNet, a division of DSS, and, as such, is responsible for the administration of the Missouri Medicaid program with the exception of determining eligibility. Defendant Parks holds ultimate administrative power within the MO HealthNet Division, subject to the supervision of Defendant Kinkade. He is sued in his official capacity. His principal office is located in Jefferson City, Missouri.
IV. TREATMENT STANDARDS OF CARE FOR HEPATITIS C 10. HCV is a chronic, life-threatening, communicable, blood-borne viral disease. The Missouri Department of Social Services estimates that 13,000 Missouri Medicaid beneficiaries
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are infected with HCV. 11. In addition to the baseline manifestation of chronic inflammation throughout the
body, HCV can lead to severe liver damage, infections, liver cancer, and death. Nearly 20,000 people in the United States die each year due to liver disease caused by HCV. See http://www.cdc.gov/hepatitis/Statistics/index.htm (last visited 1/25/16). Even before the advanced stages of the disease, individuals with HCV can suffer from heart attacks, fatigue, joint pain, depression, sore muscles, and arthritis. Up to 70% of those with HCV will develop chronic liver disease, 20% will develop cirrhosis, and 5% will develop liver cancer. HCV is the leading indication for liver transplants in the United States. See http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm (last visited 2/3/16).
12. The severity of HCV is measured by a fibrosis score, which assesses the health of the liver according to the level of liver scarring. The scoring ranges from a score of F0 (mild scarring or scarring absent) to F4 (significant liver damage; cirrhosis).
13. Until recently, the standard of care for the treatment of HCV was a three-drug treatment containing boceprevir, interferon and ribavirin. The treatment only provided at most a 70% cure rate, and was accompanied by significant adverse side effects such as anemia, insomnia, anxiety, depression, nausea, bone pain, muscle pain, joint pain, memory loss and death.
14. On November 22, 2013, the U.S. Food and Drug Administration (“FDA”) approved a new direct acting antiviral (DAA) treatment for HCV: a single-pill treatment containing simeprevir sold by Janssen Pharmaceutical under the trade name Olysio®. The FDA designated Olysio® a “breakthrough treatment” because it showed potential to provide a substantial improvement over existing therapies. Since approving Olysio®, the FDA has
4 Case 2:16-cv-04273-SRB Document 1 Filed 10/18/16 Page 4 of 19

approved seven other DAA treatments for HCV: Solvaldi®, Harvoni®, Viekira Pak®, Daklinza®, Technivie®, Zepatier®, and Epclusa®. All of the approved DAA treatments for HCV have been granted breakthrough status by the FDA. Clinical studies of each DAA treatment find that the treatment cures HCV in upwards of 90% of cases.
15. DAAs are the standard of medical care for the treatment of nearly all those with HCV, regardless of fibrosis score. Treatment guidelines approved by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (“AASLD/IDSA”) provide that DAAs should not be reserved for only individuals with fibrosis scores of F3 and F4. See http://hcvguidelines.org/ (last visited 10/14/16). Rather, the standard of care is treating “all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy.” See http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy (last visited 10/14/16). Treating nearly all HCV patients is the standard of care in the community.
16. There are no equally effective alternative medications or medical interventions to the use of DAAs. DAAs are the only medication or medical intervention for HCV that produce a sustained virologic response (“SVR”) in more than 90% of patients. Without treatment with DAAs, individuals infected with chronic HCV will never rid themselves of the inflammatory disease, thus placing them at significantly higher risk for extrahepatic symptoms, liver disease, liver cancer, and even death.
17. HCV is a communicable disease. The CDC lists groups of people known to be at increased risk for HCV infection, including health care workers after needle-sticks involving HCV-positive blood and infants born to HCV-positive mothers. See http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm (last visited 2/3/16).
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V. STATUTORY AND REGULATORY FRAMEWORK Medicaid
18. Title XIX of the Social Security Act, codified at 42 U.S.C. §§ 1396–1396w-2 (“Medicaid Act”), establishes the Medicaid program. The objective of the Medicaid Act is to enable each State to furnish medical assistance to families with children and to aged, blind, or disabled individuals whose incomes and resources are insufficient to meet the costs of necessary medical services and to furnish “rehabilitation and other services to help such families and individuals attain or retain capability for independence or self-care.” 42 U.S.C. § 1396-1.
19. Medicaid is a cooperative federal-state program. Participation in the Medicaid program is not mandatory for the states, but once they choose to participate, they must operate their programs in conformity with federal statutory and regulatory requirements. 42 U.S.C. § 1396a.
20. Each state choosing to participate in the Medicaid program must designate a single state agency which is responsible for administering the program. 42 U.S.C. § 1396a(a)(5).
21. The Medicaid Act requires participating states to “provide for making medical assistance available . . . to [all eligible individuals].” 42 U.S.C. § 1396a(a)(10)(A). “Medical assistance” is defined as “payment of part or all of the cost of . . . care and services” included in an enumerated list of twenty-nine general categories of assistance. 42 U.S.C. § 1396d(a). Some of the categories of assistance are mandatory and must be included within a state’s Medicaid plan, whiles others are optional. See 42 U.S.C. § 1396a(a)(10)(A).
22. States have the option to cover prescription drugs. 42 U.S.C. § 1396d(a)(12). Missouri has chosen to provide prescription drug coverage as part of its State Medicaid Plan.
23. Among other things, the Medicaid Act requires states’ coverage of prescription
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drugs to comply with the requirements of 42 U.S.C. § 1396r-8. With limited exceptions not

relevant here, Missouri must cover the drugs that are manufactured by companies that have

entered into rebate agreements with the Secretary of the U.S. Department of Health and Human

Services for their “medically accepted indications.” A medically accepted indication means any

use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic

Act or a use that is supported by one of three congressionally-approved drug compendia. 42

U.S.C. §§ 1396a(a)(54), 1396d(a)(12), 1396r-8(d), 1396r-8(k)(6).

24. All of the manufacturers of the drugs at issue here have entered into rebate

agreements, and the U.S. Food and Drug Administration (FDA) has approved use of the drugs

for treatment of Hepatitis C.

25. Under the federal Medicaid Act, the state can impose utilization review

techniques on drugs, as long as the state ensures access to drugs for their medically accepted

indications. 42 U.S.C. § 1396r-8(d)(5).

26. In November 2015, the Centers for Medicare & Medicaid Services (“CMS”), the

federal Medicaid agency, issued policy guidance for states on the outpatient drug coverage

requirements for direct-acting antiviral (“DAA”) treatment for HCV treatments, such as Harvoni

and Epclusa. CMS, Assuring Medicaid Beneficiaries Access to Hepatitis C (HCV) Medications

(2015),

https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-

Topics/Benefits/Prescription-Drugs/Downloads/Rx-Releases/State-Releases/state-rel-172.pdf.

After specifying the limited circumstances in which states may exclude or restrict coverage of an

FDA-covered drug, CMS advised states that they “are required to provide coverage” for FDA-

approved drugs once the manufacturer enters into the rebate agreements described in the Act

“when such drugs are prescribed for medically accepted indications, including the new DAA

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drugs.” Id. at 2-3 (emphasis added). While noting that states have the discretion to establish utilization controls on the coverage of these drugs, such as preferred drug lists and use of prior authorization processes, CMS underscored that the practices must be consistent with the Act, and that states’ “limitations should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections.” Id. at 3.
27. Defendants cover DAAs, including Harvoni and Epclusa, under the Missouri State Medicaid Plan, but only for the most severely ill individuals. Defendants refuse to cover the medication for Medicaid enrollees with less severe liver damage or other symptoms of HCV, even though the coverage is for a medically accepted indication as recognized by the FDA and the medications will likely cure them. Since DAAs meet the standard for coverage under the Medicaid program, the Medicaid Act requires coverage of the medicine when it is for a medically accepted indication. 42 U.S.C. §§ 1396a(a)(10)(A), 1396r-8.
28. Covered prescription drugs, including DAAs, must be made available to Medicaid beneficiaries when medically necessary, with “reasonable promptness,” for all comparable Medicaid enrollees. 42 U.S.C. § 1396a(a)(8).
29. The prescription drug coverage, including access to Harvoni, Epclusa, and other DAAs, that is made available to an individual eligible under the State Medicaid Plan cannot be less in amount, duration or scope than the coverage made available to any other such individual. 42 U.S.C. § 1396a(a)(10)(B), 42 C.F.R. § 440.240, 42 C.F.R. § 440.230(b) (requiring states to ensure that the amount, duration, and scope of coverage are reasonably sufficient to achieve the purpose of the service). This is known as Medicaid’s “comparability” requirement.
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30. Controlling Eighth Circuit precedent requires the State to cover all nonexperimental, medically necessary services, within a covered Medicaid category. Lankford v. Sherman, 451 F.3d 496 (8th Cir. 2006); Weaver v. Reagen, 886 F.2d 194, 198 (8th Cir. 1989). “[A] state’s failure to cover non-experimental, medically necessary services within a covered Medicaid category is both per se unreasonable and inconsistent with the stated goals of Medicaid.” 451 F.3d at 511.
31. The Eighth Circuit has previously rejected restrictions on prescription drugs that, “reflect . . . inadequate solicitude for the applicant’s diagnosed condition, the treatment prescribed by the applicant’s physicians and the accumulated knowledge of the medical community.” Weaver, 886 F.2d at 200 (quoting Pinneke v. Preisser, 623 F.2d 546 (8th Cir. 1980) (emphasis added)).
VI. MISSOURI’S COVERAGE CRITERIA FOR HEPATITIS C 32. The State of Missouri has elected to participate in the Medicaid program and has designated DSS as the single state Medicaid agency. DSS is a department of state government. 33. The federal government shares the cost of the Missouri Medicaid program by providing funding to the State of Missouri. The federal government pays approximately 63 cents of each dollar spent on Medicaid services in Missouri. 79 Fed. Reg. 71428 (Dec. 2, 2014). 34. The MO HealthNet Division indicated on June 23, 2016 that it “agrees with the AASLD/IDSA recommendation that ALL patients should be treated” and that it welcomes the opportunity for every HCV infected patient to have the chance to be “cured.” 35. However, Defendants have adopted coverage criteria with respect to when and under what conditions it will approve Harvoni and other similar DAAs for coverage under Missouri’s Medicaid program that are more restrictive than the national standards of care.
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Missouri Pharmacy Program Preferred Drug List Hepatitis C Therapy (Effective 8/01/2005, Revised 10/1/2015, http://dss.mo.gov/mhd/cs/pharmacy/pdf/hepatitis-c-therapy.pdf.)
36. Defendants have presented these coverage criteria to the MO HealthNet Oversight Committee, a statutorily-created body that advises Missouri’s Medicaid program. http://dss.mo.gov/mhd/oversight/pdf/150217-hepatitis-c-therapy.pdf
37. Defendants do not provide coverage for all Medicaid beneficiaries with HCV. Defendants’ coverage criteria exclude coverage of DAAs for Medicaid enrollees with HCV genotypes 1, 2, and 4 with fibrosis scores of F0, F1 and F2; and exclude coverage of DAAs for Medicaid enrollees with HCV genotype 3 at fibrosis scores of F0 and F1.
38. Defendants report that they have approved “some participants” for coverage of DAAs with fibrosis scores of less than F3 based on other specifics of their condition, but their published prior authorization criteria do not reflect this practice. Defendants’ criteria do not include specific factors under which individuals with these lower scores can seek to qualify for coverage of DAAs.
39. Fibrosis score is not an acceptable medical reason for denying access to medically necessary DAAs. Plaintiffs were denied DAAs because they did not have fibrosis scores of F3 or F4.
40. Defendants prioritize treatment for Hepatitis C patients who they believe “most urgently need it” rather than provide it to patients for whom such treatment is medically necessary. Defendants’ policy is to “defer” treatment until a patient reaches a more advanced stage of liver disease, as measured by fibrosis requirements. The deferral policy has resulted in Plaintiff J.L.M. waiting over three months, so far, and Plaintiff J.E.M waiting over seven months, so far, for coverage.
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41. Defendants’ coverage criteria are inconsistent with accepted medical practice. Defendants have no clinical or medical basis to deny treatment to Medicaid enrollees who have a fibrosis score of F0, F1 or F2. On the contrary, the HCV Guidelines provide that “[b]ecause of the myriad benefits associated with successful HCV treatment, clinicians should treat HCVinfected patients with antiviral therapy with the goal of achieving an SVR, preferably early in the course of their chronic HCV infection before the development of severe liver disease and other complications.” See http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy (last visited 10/14/16). Treatment of HCV even in patients with mild or no liver disease decreases complications and death rate due to liver disease and prevents transmission of HCV to others.
42. Medicaid enrollees who meet the standards set forth by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, but who are excluded under Defendants’ coverage criteria, are at risk. They are needlessly exposed to health conditions caused by HCV, including cirrhosis, cancer, fatigue, joint pain, depression, sore muscles, arthritis, avoidable liver transplants, jaundice and even death. In addition, the lack of treatment of infected individuals increases the chance that members of the insured’s household and the public will be exposed to and contract HCV.
43. Defendants’ authorization criteria also deny DAAs to anyone who has tested positive for alcohol or illicit drug use. Patients must undergo three months of “abstinence” testing (which means they must test negatively for drug and alcohol use three times over three months) before MO HealthNet will consider an authorization request for DAAs.
44. This abstinence requirement is inconsistent with AASLD/IDSA guidelines, which do not require abstinence as precondition for treatment. This requirement further delays
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medically necessary treatment to infected patients, allowing their liver disease to progress unnecessarily, and placing them at additional risk. Denying access to DAAs for individuals who test positive for drug use means that such individuals are more likely to spread the disease through sharing of needles.
45. Defendants’ coverage criteria are not based on requirements of the Medicaid Act. Rather, Defendants’ denial of coverage is an effort to ration care because of its concern over the cost of DAAs. The Defendants’ coverage policies result in long delays for medically necessary services, and they exclude some Medicaid enrollees with HCV from medically necessary DAA treatment while providing the same treatment to other Medicaid enrollees with HCV.
Plaintiffs Require DAAs to Treat Their HCV 46. Plaintiffs are enrolled in the Missouri Medicaid program. Both individuals qualify for Medicaid because they meet requirements of 42 U.S.C. § 1396a(a)(10)(A). 47. Plaintiffs have been diagnosed with HCV. Plaintiffs seek treatment with DAAs, which are recommended for nearly all patients diagnosed with chronic HCV infection by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, and have been prescribed by their treating physicians. There is no alternative medication or medical intervention that will provide Plaintiffs with equally beneficial results.
Plaintiff J.E.M. 48. J.E.M. is 45 years old and lives alone in Imperial, Missouri. 49. J.E.M. has been diagnosed with Hepatitis C for approximately five years. He also suffers from pancreatitis, spinal osteoarthritis, and high blood pressure.
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50. Because of his disabilities, J.E.M. is unable to work. He receives Supplemental Security Income of $733 per month and approximately $190 in food stamps. He has Medicaid coverage based on his disabilities.
51. Because of his Hepatitis C, J.E.M. has experienced a significant decrease in energy and motivation. He is concerned about the possibility of infecting others and takes daily precautions to ensure he does not pass the disease on to others.
52. J.E.M.’s father recently passed away due to his Hepatitis C and resulting liver cancer. J.E.M. is especially concerned about the effects additional liver damage will have on his life due to this first-hand experience witnessing the impact it had on his father. Because Defendants’ policies require his liver to incur more damage before he can be cured, J.EM. feels he is in a hopeless situation.
53. J.E.M.’s treating physician has prescribed Harvoni to cure his Hepatitis C. J.E.M.’s doctor wrote a prescription to Premier Pharmacy Services on March 3, 2016.
54. Prescriptions for Harvoni require prior authorization approval from MO HealthNet. However, before MO HealthNet will consider approval, it requires three clean “drug screens.”
55. Abstinence from drugs or alcohol is not a condition for the receipt of antiviral drugs according to the standard of care for DAA treatment.
56. J.E.M. underwent urine testing on March 25, 2016; May 19, 2016; and June 16, 2016. All of his tests were “clean,” showing no non-prescription drug or alcohol use.
57. On or about July 6, 2016, Premier submitted a prior authorization request to MO HealthNet for J.E.M.’s Harvoni.
58. On July 6, 2016, MO HealthNet denied this request.
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59. MO HealthNet letter sent a letter to J.E.M. stating that the request was denied because “the information submitted did not meet the criteria established to obtain authorization for this drug.”
60. A denial notice sent to J.E.M.’s doctor stated that “the patient does not meet Mo HealthNet’s criteria for a fibrosis score of F3 or greater. The patient’s fibrosis score is F2 [F1F2].”
61. MO HealthNet did not offer J.E.M. any other medication as an alternative to treat his Hepatitis C.
62. Waiting for his fibrosis to progress from F2 to F3 means J.E.M. will have to incur further irreversible organ damage before his disease can be cured.
Plaintiff J.L.M. 63. Plaintiff J.L.M. is 36 years old and lives with her two teenage daughters in Foley, Missouri. 64. J.L.M. was diagnosed with Hepatitis C in April 2016. She also has a diagnosis of fibromyalgia. 65. Because of her disabilities, J.L.M. is unable to work. She is a widow and receives $768 in Social Security survivor’s benefits each month. J.L.M. is covered by Medicaid based on her disabilities. 66. Because of her Hepatitis C, J.L.M.’s fibromyalgia has worsened, and she experiences frequent pain and fatigue. Her preexisting anxiety has also increased significantly. 67. J.LM. lives in constant fear of inadvertently infecting her children. She takes many safety precautions in her home, including bleaching her bathtub each time she shaves her legs. She is also afraid of infecting strangers and worries about what might happen if she were
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hurt in public and a stranger stopped to help her and then also became infected. J.L.M. is reluctant to leave her home because she is afraid of putting others in danger.
68. J.L.M.’s treating nurse practitioner has prescribed Epclusa® to cure her Hepatitis C. J.L.M.’s nurse practitioner wrote a prescription to Walgreens Specialty Pharmacy on July 19, 2016.
69. Prescriptions for Epclusa® require prior authorization approval from MO HealthNet. Walgreens submitted a prior authorization request to MO HealthNet for J.L.M.’s Epclusa.
70. J.L.M. underwent urine testing on June 8, 2016; July 7, 2016; and July 22, 2016. All of her tests were “clean,” showing no non-prescription drug or alcohol use.
71. On August 26, 2016 MO HealthNet denied the prior authorization request for Epclusa.
72. J.L.M. did not receive a letter explaining the reason for this denial. 73. Walgreens sent a fax to J.L.M.’s doctor that stated the request was “denied Epclusa due to low F-score. At this point there are no other options in which to proceed as she has MO Medicaid. She will need to advance to F3/F4 in order for MO Medicaid to approve her.” 74. A denial notice sent to J.L.M.’s nurse practitioner stated that “the patient does not meet Mo HealthNet’s criteria for a fibrosis score of F3 or greater. The patient’s fibrosis score is F0.” 75. MO HealthNet did not offer any other medication as an alternative to treat her Hepatitis C. 76. Waiting for her fibrosis to progress from F0 to F3 means that J.L.M. will have to incur further irreversible organ damage before her disease can be cured.
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Other Plaintiff Facts 77. Treatment with DAAs is “medically necessary” for Plaintiffs and others, as determined by their treating physicians, and is consistent with the standard of care in the medical community. 78. Defendants take the position that Plaintiffs’ treatment may be delayed until a fibrosis score of F3 or F4 is reached. This position is inconsistent with clinical studies of HCV treatments, the AASLD/IDSA Treatment Recommendations and the standard of care for treatment of HCV in Missouri. 79. At all times relevant, Defendants have acted under color of state law in failing and refusing to provide coverage of medically necessary DAAs for Plaintiffs. 80. There is no plain, adequate, or complete remedy at law to prevent or redress the harm suffered by Plaintiffs as a result of Defendants’ failure and refusal to provide coverage of medically necessary Hepatitis C drugs. 81. Plaintiffs are suffering and will suffer irreparable harm as a result of Defendants’ ongoing unlawful failure to cover medically necessary drugs for treating Hepatitis C.
VII. CLAIMS FOR RELIEF First Claim for Relief: Violations of Medicaid Entitlement to Appropriate Amount,
Duration, and Scope of Treatment 82. Plaintiffs restate and incorporate by reference paragraphs 1 through 81 above. 83. Plaintiffs are entitled to declaratory and injunctive relief pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 because Defendants are violating Title XIX of the Social Security Act by excluding Medicaid beneficiaries from medically necessary treatment as required by 42 U.S.C. §§ 1396a(a)(10)(A) and 1396d(a)(12).
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Second Claim for Relief: Violations of Medicaid Comparability 84. Plaintiffs restate and incorporate by reference paragraphs 1 through 83 above. 85. Plaintiffs are entitled to declaratory and injunctive relief pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 because Defendants, by discriminating among similarly situated Medicaid beneficiaries on the basis of categorical restrictions that are not based upon prevailing clinical standards, are violating Medicaid Act comparability requirements, 42 U.S.C. § 1396a(a)(10)(B)(i).
Third Claim for Relief: Violations of Reasonable Promptness 86. Plaintiffs restate and incorporate by reference paragraphs 1 through 85 above. 87. Plaintiffs are entitled to declaratory and injunctive relief pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 because Defendants are violating the “reasonable promptness” requirement of Title XIX of the Social Security Act, 42 U.S.C. § 1396a(a)(8), by implementing a policy that de facto rations coverage for Medicaid enrollees seeking HCV treatment, thereby requiring Plaintiffs and those like them to wait until they have developed severe liver damage before receiving medically necessary treatment.
REQUEST FOR RELIEF A. Assume jurisdiction over this action; B. Issue a declaratory judgment holding that Defendants may not apply policies or practices that exclude or impermissibly limit treatment of HCV with Harvoni®, Epclusa®, or other similar DAAs pursuant to coverage criteria that are inconsistent with the current AASLD/IDSA Treatment Guidelines; C. Grant preliminary and permanent injunctions that prohibit Defendants from implementing and enforcing the current HCV Treatment Policy (dated October 1, 2015) or
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otherwise impermissibly limiting access to medically necessary DAAs, and from refusing to
provide Medicaid coverage of medically necessary Hepatitis C drugs for Plaintiffs as determined
by their physicians;
D. Require Defendants to provide corrective notice to all Medicaid
beneficiaries including Plaintiffs, denied coverage under DSS’s current HCV Treatment Policy,
informing them of a state-based procedure that will be developed, implemented, and available to
them for determining whether they qualify for DAAs pursuant to revised criteria that are
consistent with the current AASLD/IDSA Treatment Guidelines;
E. Award Plaintiffs their reasonable attorneys’ fees and costs; and
F. Grant such other and further relief as may be just and proper.
Respectfully submitted,
/s/ Joel Ferber Joel Ferber # 35165 Jamie L. Rodriguez # 64323 Legal Services of Eastern Missouri, Inc. 4232 Forest Park Avenue St. Louis, Missouri 63108 (314) 534-4200 telephone (314) 534-1028 facsimile jdferber@lsem.org jlrodriguez@lsem.org
/s/ John J. Ammann John J. Ammann # 34308 Saint Louis University Legal Clinic 321 N. Spring Street St. Louis, Missouri 63108 (314) 977-2778 telephone (314) 977-1180 facsimile ammannjj@slu.edu
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/s/ Abigail K. Coursolle Abigail K. Coursolle M. Jane Perkins National Health Law Program, Inc. 3701 Wilshire Blvd, Suite #750 Los Angeles, CA 90010 (310) 204-6010, Ext. 107 telephone (213) 368-0774 facsimile coursolle@healthlaw.org perkins@healthlaw.org ATTORNEYS FOR PLAINTIFFS
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 IN THE UNITED STATES DISTRICT COURT WESTERN DISTRICT OF MISSOURI CENTRAL DIVISION

J.E.M., et al., v.

Plaintiffs,

BRIAN KINKADE, in his official capacity as Director of the Missouri Department of Social Services, et al.,
Defendants.

)

)

)

)

)

Case No. 16-cv-04273-SRB

)

)

)

)

)

)

)

ORDER

Before the Court is Defendants’ Motion to Dismiss. (Doc. #33). For the reasons stated

below, the motion is denied.

I. Background

Plaintiffs J.E.M. and J.L.M, Missouri Medicaid beneficiaries with Hepatitis C virus (“HCV”), bring this suit against Defendant Brian Kinkade in his official capacity as Director of the Missouri Department of Social Services, and Joe Parks, M.D., in his official capacity as Director of the MO HealthNet Division, alleging Plaintiffs are being denied medically-necessary, direct-acting antiviral treatment (DAAs) in violation of the Medicaid Act. Plaintiffs’ Complaint includes three claims for relief: 1) a 42 U.S.C. § 1983 claim for failure to provide medicallynecessary prescription drugs in violation of 42 U.S.C. §§ 1396a(a)(10)(A) and 1396(d)(a); 2) a 42 U.S.C. § 1983 claim for violation of the Medicaid Act’s “comparability” requirement at 42 U.S.C. § 1396a(a)(10)(B); and 3) a 42 U.S.C. § 1983 claim for violation of the Medicaid Act’s “reasonable promptness” requirement at 42 U.S.C. § 1396a(a)(8).

Case 2:16-cv-04273-SRB Document 41 Filed 02/02/17 Page 1 of 5

Plaintiffs’ suit challenges MO HealthNet’s published Approval Criteria requiring three
months of negative urine alcohol and drug screens before submitting a request for DAA
approval, and a fibrosis score of at least F2 or F3 depending on the patient’s genotype. Plaintiffs
argue the challenged criteria have no impact on the medical necessity of DAAs for HCV
patients, and by applying the criteria, Mo HealthNet is failing to provide medically-necessary
prescription drugs in violation of 42 U.S.C. §§ 1396a(a)(10)(A) and 1396d(a). Plaintiffs further
argue that application of the challenged criteria violates the Medicaid Act’s “comparability”
requirement at 42 U.S.C. § 1396a(a)(10)(B) and “reasonable promptness” requirement at 42
U.S.C. § 1396a(a)(8).
Defendants ask the Court to dismiss Plaintiffs’ Complaint in its entirety for failure to
state a claim. Defendants argue:
[T]he crux of all three of Plaintiffs’ claims is methodology, i.e. that DAAs are medically necessary for all participants diagnosed with HCV, thus according to MHD’s published prior authorization criteria, which appear to restrict DAAs to those participants with fibrosis scores of F3 or F4, some participants must wait until their liver disease has progressed to the level of F3 to receive DAAs. . . .
[S]uch a challenge must be brought under the Act’s reasonable-standards requirement at 42 U.S.C. § 1396a(a)(17) (requiring participating states to “include reasonable standards . . . for determining eligibility for and the extent of medical assistance under the plan which (A) are consistent with the objectives of this title . . .”) (emphasis added). It follows then that Plaintiffs’ claims for relief actually arise as § 1983 challenges to an alleged violation of § 1396a(a)(17).
(Doc. #34, p. 6). Defendants further argue that Plaintiffs’ claims must be dismissed because
“[t]here is no individualized federal right to reasonable Medicaid standards enforceable under 42
U.S.C. § 1983.” (Doc. #34, p. 4).
Plaintiffs counter that they may choose their causes of action, and their Complaint does
not include a claim under 42 U.S.C. § 1396a(a)(17). Plaintiffs further argue, “Plaintiffs do not
challenge Defendants’ right to limit access to prescription drugs using a preferred drug list, prior
2
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authorization, or utilization review, but they do maintain that under the service availability, comparability, and reasonable promptness provisions of the Medicaid Act, the specific limits Defendants have placed on DAAs are illegal.” (Doc. #37, p. 5).
II. Legal Standard
Pursuant to Fed. R. Civ. P. 12(b)(6), a claim may be dismissed for “failure to state a claim upon which relief can be granted.” The Court must consider all facts alleged in the Complaint as true when considering a motion to dismiss. See Data Mfg., Inc. v. United Parcel Service, Inc., 557 F.3d 849, 851 (8th Cir. 2009) (noting “[t]he factual allegations of a complaint are assumed true and construed in favor of the plaintiff, even if it strikes a savvy judge that actual proof of those facts is improbable”). “To survive a motion to dismiss [for failure to state a claim], 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 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)) (internal citations omitted); Zink v. Lombardi, 783 F.3d 1089, 1098 (8th Cir. 2015). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678; Ash v. Anderson Merchs., LLC, No. 14–3258, 2015 WL 4978701, at *1 (8th Cir. 2015).
III. Discussion
The Court agrees with Plaintiffs that they are the “masters of their complaint” and may choose their causes of action. See Johnson v. MFA Petroleum Co., 701 F.3d 243, 247 (8th Cir. 2012) (stating plaintiff may avoid federal jurisdiction by choosing to allege only state-law claims). Furthermore, Defendants mischaracterize Plaintiffs’ allegations. Plaintiffs do not allege
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that the challenged Approval Criteria are merely “unreasonable.” Rather, Plaintiffs allege that the challenged Approval Criteria are illegal and in effect deny, rather than just restrict, medically necessary treatment to Missouri Medicaid patients with HCV. (Doc. #1, ¶37). While Defendants challenge Plaintiffs’ allegations, these factual challenges are not appropriate considerations at the motion to dismiss stage.
Defendants rely primarily upon Weaver v. Regan, 886 F.2d 194, 198 (8th Cir. 1989), in support of their argument that “this is a reasonable standards claim and is not privately enforceable.” (Doc. #38, p. 2). Defendants refer the Court to the sentence that states, “This provision [42 U.S.C. § 1396a(a)(17)] has been interpreted to require that a state Medicaid plan provide treatment that is deemed ‘medically necessary’ in order to comport with the objectives of the Act.” Id. Defendants’ reliance on this single statement ignores that in deciding Weaver the Eighth Circuit affirmed the district court’s ruling that was based on 42 C.F.R. §§ 440.230(b), 440.230(b), and 42 U.S.C. § 1983.
The Eighth Circuit stated, “The trial court held that defendants’ rule limiting Medicaid coverage of AZT to only those recipients who meet certain diagnostic criteria or conditions violated federal Medicaid law, 42 C.F.R. §§ 440.230(b), 440.240(b), and 42 U.S.C. § 1983.” Weaver, 886 F.2d at 197. Section 440.230(b) provides, “Each service must be sufficient in amount, duration, and scope to reasonably achieve its purpose.” Section 440.240(b) provides, “The plan must provide that the services available to any individual in the following groups are equal in amount, duration, and scope for all beneficiaries within the group: (1) The categorically needy.” These Code of Federal Regulations sections correspond to the Medicaid Act provisions upon which Plaintiffs’ claims are based. Accordingly, Weaver supports denial of Defendants’ motion.
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Notably, Defendants do not argue that Plaintiffs’ service availability, comparability, and reasonable promptness claims are not privately enforceable under 42 U.S.C. § 1983. As a result, the Court need not address the issue.
IV. Conclusion Accordingly, for the foregoing reasons it is hereby ORDERED that Defendants’ Motion to Dismiss (Doc. #33) is DENIED. IT IS SO ORDERED.

Dated: February 2, 2017

/s/ Stephen R. Bough STEPHEN R. BOUGH UNITED STATES DISTRICT JUDGE

5 Case 2:16-cv-04273-SRB Document 41 Filed 02/02/17 Page 5 of 5

 
 IN THE UNITED STATES DISTRICT COURT WESTERN DISTRICT OF MISSOURI CENTRAL DIVISION

J.E.M., et al.,

)

)

Plaintiffs,

)

)

v.

)

)

)

JENNIFER TIDBALL, in her official capacity )

as Acting Director of the Missouri Department of )

Social Services, et al.,

)

)

Defendants.

)

Case No. 16-cv-04273-SRB

ORDER

Before the Court is Plaintiffs’ Motion for Preliminary Injunction (Doc. #2) asking the

Court to enjoin Defendant Jennifer Tidball, in her official capacity as Acting Director of the

Missouri Department of Social Services, and Defendant Jay Ludlum, in his official capacity as

Acting Director of MO HealthNet Division, from applying certain state-imposed, drug-treatment

policies that deny some Medicaid beneficiaries with Hepatitis C virus the direct-acting antiviral

treatment (“DAAs”) prescribed by their doctors, at least in part, based on fibrosis score. Upon

consideration of the record, including but not limited to the evidence submitted during the

evidentiary hearing held on March 10, 2017, the motion is DENIED.

I. Procedural and Factual Background

Plaintiffs J.E.M. and J.L.M are Medicaid beneficiaries with Hepatitis C virus (“HCV”). Plaintiffs’ Complaint includes three claims for relief: 1) a 42 U.S.C. § 1983 claim for failure to provide medically-necessary prescription drugs in violation of 42 U.S.C. §§ 1396a(a)(10)(A) and 1396d(a); 2) a 42 U.S.C. § 1983 claim for violation of the Medicaid Act’s “comparability”

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requirement at 42 U.S.C. § 1396a(a)(10)(B); and 3) a 42 U.S.C. § 1983 claim for violation of the Medicaid Act’s “reasonable promptness” requirement at 42 U.S.C. § 1396a(a)(8).
The Court ruled previously on a portion of Plaintiffs’ Motion for Preliminary Injunction. On February 2, 2017, the Court entered an order granting Plaintiffs’ request for a preliminary injunction enjoining Defendants from requiring three months of negative drug and alcohol screens prior to submitting requests for DAA approval. At that time, the Court deferred its ruling on the fibrosis score issue. The Court stated, “The Court finds, however, that an evidentiary hearing is necessary before the Court can rule on Plaintiffs’ request for a preliminary injunction prohibiting Defendants from applying policies and prior authorization criteria regarding fibrosis scores because a material factual dispute exists regarding the medical necessity of treating all HCV patients with DAAs regardless of fibrosis score.” (Doc. #40, pp. 1-2).
An evidentiary hearing was held on March 10, 2017. Plaintiffs presented evidence through the testimony of Dr. Bruce R. Bacon, and Defendants presented evidence through the testimony of Dr. Ronald L. Koretz and Steven Michael Calloway, R.Ph. Dr. Bacon is a professor of internal medicine at St. Louis University and served previously as the director of the division of gastroenterology. Dr. Bacon is a high-volume provider who sees patients with all types of liver disease including HCV. Dr. Koretz is presently an Emeritus Professor of clinical medicine at David Geffen-UCLA School of Medicine, and up until his retirement in 2006, he served as the Chief of Gastroenterology at the Olive View-UCLA Medical Center. Stephen Michael Calloway is the Director of Pharmacy with Mo HealthNet and has held the job since January 2015. Both Plaintiffs and Defendants admitted new exhibits during the course of the evidentiary hearing. The Court has considered the entirety of the evidentiary record in reaching its decision that
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Plaintiffs have not established their entitlement to a preliminary injunction prohibiting Defendants from considering fibrosis scores in deciding whether to approve DAA treatments.
a. HCV and Fibrosis Scores
HCV is a blood-borne virus that predominately affects the liver. Patients with HCV for more than six months are said to have chronic HCV. Patients with chronic HCV can progress to have cirrhosis of the liver or liver cancer, but not all patients with HCV will progress to that point. The parties presented conflicting evidence regarding the percentage of chronic HCV patients whose condition will progress to the point of cirrhosis or liver cancer. Dr. Bacon testified that 20% - 50% of chronic HCV patients will progress to end stage liver disease while Dr. Koretz testified the number is closer to 15%. Even so, all witnesses agreed that not all chronic HCV patients will progress, and it is impossible to predict which patients will progress, with the caveat that patients who consume alcohol or those with certain comorbidities such as HIV or co-infectional Hepatitis B are more likely to progress.
One symptom of HCV is fibrosis, the scarring of the liver caused by inflammation. The level of fibrosis is measured by a fibrosis score. The term “fibrosis score” as used throughout this Order refers to Metavir fibrosis score, one of the most commonly used scoring systems for measuring liver disease. A fibrosis score ranges from F0 (mild or no scarring) to F4 (significant liver damage/cirrhosis). The demarcation between fibrosis levels is not a bright line, but rather, progression is based on a continuum. HCV is divided into six distinct types, called genotypes.
The rate of progression varies, but on average it will take decades for an HCV patient to progress from F0 to F4. There is no strong correlation between fibrosis progression and symptoms. Some HCV patients with a low fibrosis score may have severe symptoms while other
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patients with a higher fibrosis score may have no symptoms. Any cirrhosis of the liver is generally irreversible.
b. DAA Treatments
DAAs were first introduced in late 2013, and there are presently four or five different regimens available. Approximately 90%-95% of HCV patients who take DAAs will achieve a sustained virologic response (“SVR”), which refers to the lack of the virus in the patient’s bloodstream during a three-month follow-up period after completion of a twelve-week treatment regimen. The primary side effects of DAAs include headache and fatigue, although one study showed that in a very few patients co-infected with Hepatitis B, DAA treatments caused an activation of their Hepatitis B.
Dr. Bacon referred to an SVR as a “cure” while Dr. Koretz challenged the use of the term. Dr. Koretz testified that patients think “cure” means the virus is gone, it will never come back, and any liver disease will not progress. However, Dr. Koretz testified SVR has not been shown to meet those criteria, in part because no long-term randomized studies have been conducted. Dr. Koretz testified that some studies have shown even in a patient who has achieved SVR, it is possible that HCV-RNA still exists in the peripheral mononuclear cells.
c. Evidence Regarding the Standard of Care
Dr. Bacon testified that treating all HCV patients with DAAs regardless of fibrosis score is the standard of care, at least amongst high-volume providers. Dr. Koretz countered that a more restrictive approach is the standard of care in many areas, and a restrictive approach is appropriate for two, primary reasons: 1) by treating all patients, even those at F0 or F1, you will
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necessarily be treating patients whose fibrosis would never have progressed; and 2) the medical
community does not yet know what kind of long-term side effects will occur.
Plaintiffs relied on the fact that in 2014, the American Association for the Study of Liver
Disease (AASLD) and the Infectious Disease Society of America (IDSA) issued treatment
guidelines stating that DAAs should not be reserved for only patients with fibrosis scores of F3
and F4. Dr. Koretz challenged the AASLD/IDSA guidelines on the grounds they were adopted
by a panel whose member majority had conflicts of interest with the pharmaceutical industry.
Plaintiffs also relied on the fact that the Medicare system no longer considers fibrosis scores in
approving DAA treatments for Medicare recipients. Plaintiffs further relied on the November 5,
2015, release by the Centers for Medicare and Medicaid Services of the U.S. Department of
Health and Human Services which states:
CMS is concerned that some states are restricting access to DAA HCV drugs contrary to the statutory requirements in section 1927 of the Act by imposing conditions for coverage that may unreasonably restrict access to these drugs. For example, several state Medicaid programs are limiting treatment to those beneficiaries whose extent of liver damage has progressed to metavir fibrosis score F3, while a number of states are requiring matavir fibrosis scores of F4. . . .
While states have the discretion to establish certain limitations on the coverage of these drugs, such as preferred drug lists and use of prior authorization processes, such practices must be consistent with the requirements of section 1927(d) of the Act to ensure appropriate utilization.
As such, the effect of such limitations should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections. States should, therefore, examine their drug benefits to ensure that limitations do not unreasonably restrict coverage of effective treatment using the new DAA HCV drugs.
(Doc. #2-13, pp. 2-3). Defendants argued Missouri’s Approval/Denial criteria are in line with
the CMS release because Missouri does not limit treatment to only HCV patients with a fibrosis
5
Case 2:16-cv-04273-SRB Document 61 Filed 04/24/17 Page 5 of 14

score of F3 or F4, but rather, as will be shown in part I.e. below, Missouri conducts an individualized review of every request for DAA treatment.
Defendants argued their policy is in line with the majority of state Medicaid systems. After the hearing and at the Court’s request, Mr. Calloway compiled and submitted a chart showing the DAA treatment approval policy as it relates to fibrosis score for each state and the District of Columbia. Plaintiffs responded by submitting an affidavit of Kevin Costello, Litigation Director, Center for Health Law & Policy Innovation at Harvard Law School, which challenged four designations in Mr. Calloway’s chart. Giving Plaintiffs the benefit of the doubt with respect to their challenges, the information shows fourteen states presently do not take fibrosis score into account in deciding whether to approve DAA treatment. Conversely, the information shows thirty-six states and the District of Columbia consider fibrosis score in some respect, although not all in the same way as Missouri, in deciding whether to approve DAA treatments.
d. Plaintiffs J.E.M. and J.L.M.
J.E.M.’s and J.L.M.’s doctors prescribed DAA treatment, which was denied by Mo HealthNet. At the time Mo HealthNet reviewed the prescriptions and prior authorization requests, J.E.M. had an F2 fibrosis score, and J.L.M. had an F0 fibrosis score. Neither J.E.M. nor J.L.M requested administrative review of the denials.
J.E.M. submitted an affidavit attesting that he has been a Missouri Medicaid recipient for four years due to his disabilities, including arthritis of the spine, pancreatitis, high blood pressure, and HCV. J.E.M. further attested that Hepatitis C has negatively affected his quality of life in that he is drained of all energy and in daily physical pain, and he is no longer able to participate in activities he once enjoyed. J.E.M. is fearful he will transmit the disease to friends
6 Case 2:16-cv-04273-SRB Document 61 Filed 04/24/17 Page 6 of 14

and family and takes extra precautions around his home as a result. J.E.M.’s father had HCV and died of liver cancer, and J.E.M. is fearful the same will happen to him.
J.L.M. submitted an affidavit attesting that she is a Missouri Medicaid recipient due to her disabilities, including fibromyalgia and Hepatitis C. J.L.M. further attested that her HCV has aggravated her fibromyalgia, and her body aches more. J.L.M. suffers anxiety as a result of her diagnosis. J.L.M. is also fearful she will transmit the disease to her family and takes extra precautions around her home as a result.
e. Current Missouri Approval/Denial Criteria for DAA Treatments
After the Court granted part of Plaintiffs’ motion for preliminary injunction on February 2, 2017, but before the evidentiary hearing on March 10, 2017, MO HealthNet revised its DAA Preferred Drug List for DAAs and the associated Approval Criteria. (Doc. #51-1). The Approval Criteria now provide that DAAs will be approved for HCV patients with genotype 1, 2, or 4, who have a fibrosis score equal to or greater than F3 or who have a fibrosis score of F0-F2 with certain comorbidities. The Approval Criteria further provide that DAAs will be approved for HCV patients with genotype 3 who have a fibrosis score equal to or greater than F2 or who have a fibrosis score of F0-F1 with certain comorbidities. The corresponding Denial Criteria provide that DAAs will be denied to patients with either a “fibrosis score of less than F3 for genotypes 1, 2, or 4” or a “fibrosis score of less than F2 for genotype 3[.]” (Doc. #51-1, p. 8). A footnote applicable to both Denial Criteria states, “In addition to Metavir fibrosis score, Clinical Consultant will review all therapy requests for documentation of comorbidities that may result in approval.” (Doc. #51-1, p. 8).
The previous version of the Approval Criteria and Denial Criteria provided that DAAs would only be approved for HCV patients with a fibrosis score of F3 or greater for genotypes 1,
7 Case 2:16-cv-04273-SRB Document 61 Filed 04/24/17 Page 7 of 14

2, or 4 or for HCV patients with a fibrosis score of F2 or greater for genotype 3. The previous version did not provide for individual consideration and did not allow for approval of DAAs for patients with lower fibrosis scores with comorbidities. Even though the prior criteria did not allow for individual considerations and on their face did not allow approval of DAA treatment for patients with a fibrosis score of less than F2 or F3 depending on genotype, Defendants submitted evidence that in practice an individual review was conducted for every DAA prior authorization request received and many were approved. The new criteria explicitly include this process.
f. Application of the Missouri Approval/Denial Criteria and Resulting Statistics
To obtain prior authorization for DAA treatment, a medical care provider must submit a request for Drug Prior Authorization to Mo HealthNet’s Drug Help Desk. Each request is reviewed by a registered nurse to ensure the request includes all clinical data necessary to make a decision. Once all the necessary information is received, all requests are sent to Mo HealthNet employee Mark McBride Roaseau for a comprehensive review. Mr. Roaseau is a licensed pharmacist with a medical degree. Mr. Roaseau attested in his affidavit, “I consider all information when determining whether a prior authorization request should be approved or denied. Every decision is made individually on a case by case basis upon the latest medical information based upon generally accepted medical and pharmacy practice.” (Doc. #22-4, ¶ 12).
Mo HealthNet estimates there are approximately 13,000 Missouri Medicaid patients with HCV. Since 2013, Mo HealthNet has received approximately 2,400 requests for preauthorization of DAA treatment. Of those 2,400, approximately 56% have been approved. Of those approved, approximately 33% have been HCV patients with a fibrosis score below F3.
8 Case 2:16-cv-04273-SRB Document 61 Filed 04/24/17 Page 8 of 14

II. Legal Standard
“[W]hether a preliminary injunction should issue involves consideration of (1) the threat of irreparable harm to the movant; (2) the state of balance between this harm and the injury that granting the injunction will inflict on other parties litigant; (3) the probability the movant will succeed on the merits; and (4) the public interest.” Dataphase Sys., Inc. v. C.L. Sys., Inc., 640 F.2d 109, 113 (8th Cir. 1981)). “No one factor is dispositive of a request for injunction; the Court considers all the factors and decides whether on balance, they weigh towards granting the injunction.” Grasso Enters., LLC v. Express Scripts, Inc., No. 4:14CV1932-HEA, 2015 WL 10781579, at *2 (E.D. Mo. 2015) (citations and internal quotation marks omitted). “The most important of the Dataphase factors is the . . . likelihood of success on the merits.” Shrink Mo. Gov’t. PAC v. Adams, 151 F.3d 763, 764 (8th Cir. 1998).
“In seeking a mandatory injunction that disrupts the status quo, the [movant] must demonstrate not only that the four requirements for a preliminary injunction are met but also that they weigh heavily and compellingly in their favor.” Grasso Enters., LLC, 2015 WL 10781579, at *2 (citations and internal quotation marks omitted). “In general, a mandatory preliminary injunction at the preliminary stage of the proceedings should be granted only in rare instances where the facts and law are clearly in favor of the moving party, especially if the grant of the temporary injunction would in effect give the plaintiffs the relief which they seek in the main case.” Jackson v. Conway, 476 F. Supp. 896, 902 (E.D. Mo. 1979) (citations omitted).
III. Discussion
Plaintiffs ask the Court to impose a mandatory preliminary injunction prohibiting Defendants from considering fibrosis scores in deciding whether to approve DAA treatments for
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Missouri Medicaid patients with HCV. At this stage in the proceeding and given the heightened standard applicable to a motion for a mandatory preliminary injunction, on balance, the preliminary injunction factors weigh against issuance of a preliminary injunction.
Likelihood of Success on the Merits
a. Count I – Violations of Medicaid Entitlement to Appropriate Amount, Duration, and Scope of Treatment
Missouri, like every other state, has opted to provide prescription drugs, an optional service category, as part of its Medicaid program. 42 U.S.C. § 1396d(a)(12); 13 C.S.R. 7020.030. Because prescription drugs are covered Medicaid services, Defendants must ensure that they are available to Medicaid beneficiaries in “sufficient . . . amount, duration, and scope to reasonably achieve [the] purpose” of the covered service. 42 C.F.R. § 440.230(b); 42 U.S.C. §§ 1396a(a)(10)(A), 1396d(a). “While a state has discretion to determine the optional services in its Medicaid plan, a state’s failure to provide Medicaid coverage for non-experimental, medicallynecessary services within a covered Medicaid category is both per se unreasonable and inconsistent with the stated goals of Medicaid.” Lankford v. Sherman, 451 F.3d 496, 511 (8th Cir. 2006). Accordingly, to succeed on the merits, Plaintiffs must prove that DAA treatments are medically necessary for all HCV patients regardless of fibrosis score.
Plaintiffs argue that the standard of care is to treat all HCV patients with DAAs regardless of fibrosis score. Plaintiffs rely on Dr. Bacon’s testimony, the AASLD/IDSA guidelines, the CMS release, as well as the fact that other organizations such as Medicare and some state Medicaid programs do not consider fibrosis scores in deciding whether to approve DAA treatments. Defendants counter that a more restrictive approach is well within the standard of care for treating HCV patients. Defendants rely on Dr. Koretz’s testimony, the fact that a majority of state Medicaid systems still consider fibrosis scores in some manner in deciding
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whether to approve DAA treatments, and the fact that there are approximately 13,000 Missouri Medicaid patients with HCV but since 2013 only approximately 2,400 requests for DAA treatment approval have been submitted. Defendants also argue they are in compliance with the CMS release because they do not restrict DAA treatments to patients with a fibrosis score of F3 or F4, but rather, Defendants consider each and every request individually. Defendants further point out that approximately 33% of the approvals have been for patients with fibrosis scores lower than F3. Considering all of the evidence, the Court finds Plaintiffs have not shown they are likely to succeed on the merits to a degree necessary to justify the imposition of the mandatory preliminary injunction they seek.
Plaintiffs argue that the cases of B.E. v. Teeter, No. C16-227-JCC, 2016 WL 3033500 (W.D. Wash. May 27, 2016), and Abu-Jamal, et al. v. Kerestes, 3:15-CV-00967, 2016 WL 4574646 (M.D. Penn. Aug. 31, 2016), compel issuance of a preliminary injunction in this case. The Court disagrees. First, the cases are not binding authority on this Court. In addition, the cases were decided on very different evidentiary records than the one before the Court. The Court must base its decision in this case on consideration of the Dataphase factors in the context of the evidentiary record before it.
Plaintiffs also argue that Weaver v. Reagan, 886 F.2d 194, 199 (8th Cir. 1989), requires the finding that DAAs are medically-necessary treatment if a physician prescribes DAAs as has Plaintiffs’ doctor, Dr. Bacon. Plaintiffs argue, “It is improper to interfere with a physician’s judgment of medical necessity by limiting coverage of prescription drugs based on criteria that do not reflect current medical knowledge or practice.” (Doc. #5, p. 20). The Court disagrees that a physician’s prescription will always equate to medical necessity, regardless of the other facts at issue. While Plaintiffs were prescribed DAAs, as were approximately 2,400 other HCV
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Missouri Medicaid beneficiaries, an overwhelming majority of Missouri Medicaid patients were not. In addition, Weaver is distinguishable on the fact. There the Court characterized the Medicaid rule at issue as constituting “an irrebutable presumption that AZT can never be medically necessary treatment for AIDS patients who have neither a history of PCP nor a CD4 count below 200.” Weaver, 886 F.2d at 199. Here, Defendants conduct an individualized inquiry of every DAA authorization request, and of the prescriptions approved, approximately 33% have been for patients with fibrosis scores below F3.
b. Count II – Violations of Medicaid Comparability
The Medicaid Act requires that the “medical assistance made available to any [categorically needy] individual . . . shall not be less in amount, duration, or scope than the medical assistance made available to any other such individual[.]” 42 U.S.C. § 1396a(a)(10)(B). 42 C.F.R. 440.240(a). Plaintiffs argue that because DAAs are medically necessary for all HCV patients and Defendants are not authorizing DAAs for all HCV patients, Defendants are violating this Medicaid provision. Defendants state, “[T]he Defendants are providing coverage not based on medical necessity—which is the same for all patients who contract Hepatitis C—but based on severity of liver damage.” (Doc. #18, p. 23). Because the Court has already found that Plaintiffs failed to establish they are likely to succeed in proving DAAs are medically necessary for all patients regardless of fibrosis score to a degree necessary to justify imposition of a mandatory preliminary injunction, Plaintiffs’ comparability argument fails for the same reasons.
c. Count III – Violations of Reasonable Promptness
The Medicaid Act states that covered services “shall be furnished with reasonable promptness to all eligible individuals.” 42 U.S.C. § 1396a(a)(8). Plaintiffs argue Missouri’s
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Approval/Denial Criteria “leave[] Plaintiffs waiting for medically necessary covered prescription medications well beyond the timeframe for initiation of treatment recommended by their doctors and the professional standard of care[.]” (Doc. #5, p. 24). Again, because the Court has already found that Plaintiffs failed to establish they are likely to succeed in proving DAAs are medically necessary for all patients regardless of fibrosis score to a degree necessary to justify imposition of a mandatory preliminary injunction, Plaintiffs’ reasonable promptness argument fails for the same reasons.
Likelihood of Irreparable Harm to Plaintiffs
Defendants presented evidence and Plaintiffs presented no contradictory evidence, that on average it takes several decades for HCV patients to progress from F0 to F4. The Court is mindful of and sympathetic toward the evidence regarding Plaintiffs’ present physical and mental conditions. Plaintiffs argue, however, that the irreparable harm they will suffer is the likelihood of progression. Plaintiffs argue, “Without a preliminary injunction, the Plaintiffs will not receive the medical treatment that provides them the best chance to prevent their conditions from worsening.” (Doc. #5, p. 26). The issue now, however, is what irreparable harm the Plaintiffs might suffer during the pendency of this case if Plaintiffs are not awarded the preliminary and extraordinary relief they seek. Plaintiffs presented no evidence that they are immediately at threat of progression. The pendency of this case through to completion will be but a short period of time relative to the amount of time it takes an HCV patient’s fibrosis condition to progress. Accordingly, the Court finds Plaintiffs have not shown they are subject to an immediate and irreparable injury to the degree necessary to justify imposition of a mandatory preliminary injunction.
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Balance of Equities and Public Interest
For all the same reasons already discussed, the Court finds the balance of equities favors Defendants. Given that Plaintiffs have not established they are likely to succeed on the merits to the degree necessary to justify imposition of a mandatory injunction and given the irreparable harm Plaintiffs argue will occur is not immediate, the potential consequences to Defendants of being forced to change their Medicaid DAA Approval/Denial Criteria at this early stage of the proceeding weighs in favor of denying the preliminary injunction. Finally, while the public interest in this issue is apparent given Missouri Medicaid estimates 13,000 of its beneficiaries have HCV, the weight of this consideration is not enough to tip the balance of the Dataphase factors in Plaintiffs’ favor given the Court’s findings in relation to the other factors.
IV. Conclusion
For the foregoing reasons, Plaintiffs’ Motion for a Preliminary Injunction (Doc. #2) asking the Court to enjoin Defendants from considering Missouri Medicaid beneficiaries’ fibrosis scores in deciding whether to approve DAA treatments, is denied.
IT IS SO ORDERED.

Dated: April 24, 2017

/s/ Stephen R. Bough STEPHEN R. BOUGH UNITED STATES DISTRICT JUDGE

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 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF MISSOURI
CENTRAL DIVISION

J.E.M., J.L.M., H.L.O

)

Plaintiffs,

)

)

v.

)

)

)

STEVEN CORSI, in his official

)

capacity as Director of the Missouri

)

Department of Social Services; and

)

JAY LUDLAM, in his official

)

capacity as Director of the MO HealthNet )

Division,

)

)

Defendants.

)

Case No. 16-04273-CV-C-SRB

FIRST AMENDED COMPLAINT ________________________________________________________________________
I. PRELIMINARY STATEMENT 1. This case challenges the policies of the Missouri Department of Social Services which result in the denial of medically necessary treatment for Plaintiffs J.E.M., J.L.M., H.L.O., and numerous other Medicaid beneficiaries infected with the Hepatitis C virus (HCV), a serious and communicable disease that can cause severe liver scarring, liver damage, cancer, and death. 2. This case is filed on behalf of enrollees in the Missouri Medicaid program, also known as MO HealthNet, who are infected with HCV, who meet the FDA’s standards for coverage of curative Hepatitis C medication, but who are denied coverage for medically necessary treatment because of the Defendants’ arbitrary and improper policies that restrict treatment only to the sickest beneficiaries. Without this treatment, damage to enrollees’ livers grows more severe and the risk of complications from the disease increases.

Case 2:16-cv-04273-SRB Document 71 Filed 06/06/17 Page 1 of 25

II. JURISDICTION AND VENUE

3. This action arises under Title XIX of the Social Security Act. The Court has

jurisdiction pursuant to 28 U.S.C. § 1331, which gives district courts original jurisdiction over all

civil actions arising under the Constitution, laws, or treaties of the United States, and 28 U.S.C.

§§ 1343(a)(3) and (4), which give district courts original jurisdiction over suits to redress the

deprivation under color of state law of any rights, privileges, or immunities guaranteed by the

Constitution or acts of Congress.

4. This Court has jurisdiction over this action for declaratory relief pursuant to 28

U.S.C. § 2201 and Rule 57 of the Federal Rules of Civil Procedure. Injunctive relief is

authorized by 28 U.S.C. § 2202, 42 U.S.C. § 1983, and Rule 65 of the Federal Rules of Civil

Procedure.

5. Venue is proper under 28 U.S.C. § 1391(b).

III.

PARTIES

Plaintiffs

6. Plaintiff J.E.M. is a 45-year-old Medicaid recipient living alone in Imperial,

Missouri. He suffers from a variety of medical conditions, including Hepatitis C, pancreatitis,

spinal osteoarthritis, and high blood pressure. Because of his Hepatitis C, J.E.M. has experienced

a significant decrease in energy and motivation. He also experiences anxiety regarding his

disease’s progress and the potential fatal effect of the infection, which recently took the life of

his father. His doctor has prescribed Harvoni®, ledipasvir-sofosbuvir (“Harvoni”), a drug that

will likely cure his Hepatitis C. MO HealthNet denied his prior authorization request for

Harvoni.

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7. Plaintiff J.L.M. is a 36-year-old Medicaid recipient living with her two teenage daughters in Foley, Missouri. She has Hepatitis C and also fibromyalgia. Because of her Hepatitis C, J.L.M.’s underlying fibromyalgia pain and fatigue has worsened. She also experiences continual anxiety and fear that she may inadvertently infect her children. Her doctor has prescribed Epclusa®, sofosbuvir-velpatasvir (“Epclusa”), a drug which will likely cure her Hepatitis C. MO HealthNet denied her prior authorization request for Epclusa.
8. Plaintiff H.L.O. is a 27 year old Medicaid recipient living with her three children in Belton, Missouri. H.L.O. was diagnosed with Hepatitis C early in 2017. Her fibrosis score is F0. She has no other chronic diseases. H.L.O.’s doctor has prescribed Viekira Pak™, ombitasvir/paritaprevir/ritonavir plus dasabuvir (“Viekira Pak”) for her, a drug combination that will likely cure her Hepatitis C. MO HealthNet denied her doctor’s request for a prior authorization for the drug.
Defendants 9. Defendant Steven Corsi is the Director of the Missouri Department of Social Services (“DSS”) and, as such, is responsible for the administration and implementation of laws concerning the social welfare of the people of the State of Missouri, including the Medicaid program. Defendant Corsi is the chief administrative officer of DSS and is responsible for administration of the single state agency for the Missouri Medicaid program. Defendant Corsi is charged with the ultimate control and administration of DSS, including the duty to administer the Missouri Medicaid program in compliance with the Medicaid Act. He is sued in his official capacity. His principal office is located in Jefferson City, Missouri. 10. Defendant Jay Ludlam is the Director of MO HealthNet, a division of DSS, and, as such, is responsible for the administration of the Missouri Medicaid program with the
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exception of determining eligibility. Defendant Ludlam holds ultimate administrative power within the MO HealthNet Division, subject to the supervision of Defendant Corsi. He is sued in his official capacity. His principal office is located in Jefferson City, Missouri.
IV. TREATMENT STANDARDS OF CARE FOR HEPATITIS C 11. HCV is a chronic, life-threatening, communicable, blood-borne viral disease. The Missouri Department of Social Services estimates that 13,000 Missouri Medicaid beneficiaries are infected with HCV. 12. In addition to the baseline manifestation of chronic inflammation throughout the body, HCV can lead to severe liver damage, infections, liver cancer, and death. Nearly 20,000 people in the United States die each year due to liver disease caused by HCV. See https://www.cdc.gov/hepatitis/statistics/2015surveillance/commentary.htm (last visited 5/24/17). Even before the advanced stages of the disease, individuals with HCV can suffer from heart attacks, fatigue, joint pain, depression, sore muscles, and arthritis. Up to 70% of those with HCV will develop chronic liver disease, 20% will develop cirrhosis, and 5% will develop liver cancer. HCV is the leading indication for liver transplants in the United States. See http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm (last visited 5/24/17). 13. The severity of HCV is measured by a fibrosis score, which assesses the health of the liver according to the level of liver scarring. The scoring ranges from a score of F0 (mild scarring or scarring absent) to F4 (significant liver damage; cirrhosis). 14. Until recently, the standard of care for the treatment of HCV was a three-drug treatment containing boceprevir, interferon and ribavirin. The treatment only provided at most a 70% cure rate, and was accompanied by significant adverse side effects such as anemia, insomnia, anxiety, depression, nausea, bone pain, muscle pain, joint pain, memory loss and
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death. 15. On November 22, 2013, the U.S. Food and Drug Administration (“FDA”)
approved a new direct acting antiviral (DAA) treatment for HCV: a single-pill treatment containing simeprevir sold by Janssen Pharmaceutical under the trade name Olysio®. The FDA designated Olysio® a “breakthrough treatment” because it showed potential to provide a substantial improvement over existing therapies. Since approving Olysio®, the FDA has approved seven other DAA treatments for HCV: Solvaldi®, Harvoni®, Viekira Pak™, Daklinza™, Technivie™, Zepatier®, and Epclusa®. All of the approved DAA treatments for HCV have been granted breakthrough status by the FDA. Clinical studies of each DAA treatment find that the treatment cures HCV in upwards of 90% of cases.
16. DAAs are the standard of medical care for the treatment of nearly all those with HCV, regardless of fibrosis score. Treatment guidelines approved by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (“AASLD/IDSA”) provide that DAAs should not be reserved for only individuals with fibrosis scores of F3 and F4. See http://hcvguidelines.org/ (last visited 5/24/17). Rather, the standard of care is treating “all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy.” See http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy (last visited 5/24/17). Treating nearly all HCV patients is the standard of care in the community.
17. There are no equally effective alternative medications or medical interventions to the use of DAAs. DAAs are the only medication or medical intervention for HCV that produce a sustained virologic response (“SVR”) in more than 90% of patients. Without treatment with DAAs, individuals infected with chronic HCV will never rid themselves of the inflammatory
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disease, thus placing them at significantly higher risk for extrahepatic symptoms, liver disease, liver cancer, and even death.
18. HCV is a communicable disease. The CDC lists groups of people known to be at increased risk for HCV infection, including health care workers after needle-sticks involving HCV-positive blood and infants born to HCV-positive mothers. See http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm (last visited 5/24/17). HCV can be transmitted through sexual contact, and can also be passed from mother to child during pregnancy. Because of the risk of transmission, individuals infected with HCV are advised to avoid reproduction or unprotected sexual contact.
V. STATUTORY AND REGULATORY FRAMEWORK Medicaid
19. Title XIX of the Social Security Act, codified at 42 U.S.C. §§ 1396–1396w-2 (“Medicaid Act”), establishes the Medicaid program. The objective of the Medicaid Act is to enable each State to furnish medical assistance to families with children and to aged, blind, or disabled individuals whose incomes and resources are insufficient to meet the costs of necessary medical services and to furnish “rehabilitation and other services to help such families and individuals attain or retain capability for independence or self-care.” 42 U.S.C. § 1396-1.
20. Medicaid is a cooperative federal-state program. Participation in the Medicaid program is not mandatory for the states, but once they choose to participate, they must operate their programs in conformity with federal statutory and regulatory requirements. 42 U.S.C. § 1396a.
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21. Each state choosing to participate in the Medicaid program must designate a single state agency which is responsible for administering the program. 42 U.S.C. § 1396a(a)(5).
22. The Medicaid Act requires participating states to “provide for making medical assistance available . . . to [all eligible individuals].” 42 U.S.C. § 1396a(a)(10)(A). “Medical assistance” is defined as “payment of part or all of the cost of . . . care and services” included in an enumerated list of twenty-nine general categories of assistance. 42 U.S.C. § 1396d(a). Some of the categories of assistance are mandatory and must be included within a state’s Medicaid plan, whiles others are optional. See 42 U.S.C. § 1396a(a)(10)(A).
23. States have the option to cover prescription drugs. 42 U.S.C. § 1396d(a)(12). Missouri has chosen to provide prescription drug coverage as part of its State Medicaid Plan.
24. Among other things, the Medicaid Act requires states’ coverage of prescription drugs to comply with the requirements of 42 U.S.C. § 1396r-8. With limited exceptions not relevant here, Missouri must cover the drugs that are manufactured by companies that have entered into rebate agreements with the Secretary of the U.S. Department of Health and Human Services for their “medically accepted indications.” A medically accepted indication means any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act or a use that is supported by one of three congressionally-approved drug compendia. 42 U.S.C. §§ 1396a(a)(54), 1396d(a)(12), 1396r-8(d), 1396r-8(k)(6).
25. All of the manufacturers of the drugs at issue here have entered into rebate agreements, and the U.S. Food and Drug Administration (FDA) has approved use of the drugs for treatment of Hepatitis C.
26. Under the federal Medicaid Act, the state can impose utilization review techniques on drugs, as long as the state ensures access to drugs for their medically accepted
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indications. 42 U.S.C. § 1396r-8(d)(5).

27. In November 2015, the Centers for Medicare & Medicaid Services (“CMS”), the

federal Medicaid agency, issued policy guidance for states on the outpatient drug coverage

requirements for direct-acting antiviral (“DAA”) treatment for HCV treatments, such as Harvoni

and Epclusa. CMS, Assuring Medicaid Beneficiaries Access to Hepatitis C (HCV) Medications

(2015),

https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-

Topics/Benefits/Prescription-Drugs/Downloads/Rx-Releases/State-Releases/state-rel-172.pdf.

After specifying the limited circumstances in which states may exclude or restrict coverage of an

FDA-covered drug, CMS advised states that they “are required to provide coverage” for FDA-

approved drugs once the manufacturer enters into the rebate agreements described in the Act

“when such drugs are prescribed for medically accepted indications, including the new DAA

drugs.” Id. at 2-3 (emphasis added). While noting that states have the discretion to establish

utilization controls on the coverage of these drugs, such as preferred drug lists and use of prior

authorization processes, CMS underscored that the practices must be consistent with the Act, and

that states’ “limitations should not result in the denial of access to effective, clinically

appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic

HCV infections.” Id. at 3.

28. Defendants cover DAAs, including Harvoni and Epclusa, under the Missouri

State Medicaid Plan, but only for the most severely ill individuals. Defendants refuse to cover

the medication for Medicaid enrollees with less severe liver damage or other symptoms of HCV,

even though the coverage is for a medically accepted indication as recognized by the FDA and

the medications will likely cure them. Since DAAs meet the standard for coverage under the

Medicaid program, the Medicaid Act requires coverage of the medicine when it is for a

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medically accepted indication. 42 U.S.C. §§ 1396a(a)(10)(A), 1396r-8. 29. Covered prescription drugs, including DAAs, must be made available to Medicaid
beneficiaries when medically necessary, with “reasonable promptness,” for all comparable Medicaid enrollees. 42 U.S.C. § 1396a(a)(8).
30. The prescription drug coverage, including access to Harvoni, Epclusa, and other DAAs, that is made available to an individual eligible under the State Medicaid Plan cannot be less in amount, duration or scope than the coverage made available to any other such individual. 42 U.S.C. § 1396a(a)(10)(B), 42 C.F.R. § 440.240, 42 C.F.R. § 440.230(b) (requiring states to ensure that the amount, duration, and scope of coverage are reasonably sufficient to achieve the purpose of the service). This is known as Medicaid’s “comparability” requirement.
31. Controlling Eighth Circuit precedent requires the State to cover all nonexperimental, medically necessary services, within a covered Medicaid category. Lankford v. Sherman, 451 F.3d 496 (8th Cir. 2006); Weaver v. Reagen, 886 F.2d 194, 198 (8th Cir. 1989). “[A] state’s failure to cover non-experimental, medically necessary services within a covered Medicaid category is both per se unreasonable and inconsistent with the stated goals of Medicaid.” 451 F.3d at 511.
32. The Eighth Circuit has rejected restrictions on prescription drugs that, “reflect . . . inadequate solicitude for the applicant’s diagnosed condition, the treatment prescribed by the applicant’s physicians and the accumulated knowledge of the medical community.” Weaver, 886 F.2d at 200 (emphasis added).
Due Process 33. The Due Process Clause of the U.S. Constitution requires the state Medicaid agency and its agents to provide each Medicaid recipient with adequate written notice and an
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opportunity for an impartial hearing before services are denied, reduced or terminated. U.S. Const. XIV Amend.
34. The state Medicaid agency must provide a Medicaid beneficiary with written notice when it takes the time of any action affecting his or her eligibility or coverage of services. 42 U.S.C. § 1396a(a)(3); 42. C.F.R. §§ 431.206(c)(2), 431.210, 431.220(a)(2)
35. The notice must contain: (a) a statement of what action the State intends to take; (b) the reasons for that action; (c) the specific regulations that support, or the change in Federal or State law that requires the action; (d) an explanation of – (1) the individual’s right to request an evidentiary hearing, if one is available, or a State agency hearing; or (2) in cases of an action based on a change in law, the circumstances under which a hearing will be granted; and (e) an explanation of the circumstances under which Medicaid is continued if a hearing is required. 42 C.F.R. § 431.210.
36. Due Process also requires the Medicaid program to be administered so to insure fairness and to avoid the risk of arbitrary decision making.
37. The state Medicaid program must adopt and implement ascertainable standards and procedures for determining eligibility for and the extent of medical assistance provided.
The Americans with Disabilities Act 38. The Americans with Disabilities Act, codified at 42 U.S.C. §§ 12101-12181 (hereinafter “ADA”) was enacted for the purpose of the “elimination of discrimination against individuals with disabilities.” 42 U.S.C. § 12101(b)(1). 39. Title II of the ADA prohibits discrimination against individuals with disabilities by public entities, including state and local governments, their departments, and agencies. 42 U.S.C. §§ 12131, 12132. “[N]o qualified individual with a disability shall, by reason of such
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disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of a public entity, or be subjected to discrimination by any such entity.” 42 U.S.C. § 12132; 28 C.F.R. §§ 35.130(b)(1)(iv), 35.130(b)(7), 35.130(b)(8), and 35.130(d).
40. Regulations implementing the ADA provide: “A public entity may not, directly or through contractual or other arrangements, utilize criteria or other methods of administration: (i) that have the effect of subjecting qualified individuals with disabilities to discrimination on the basis of disability; [or] (ii) that have the purpose or effect of defeating or substantially impairing accomplishment of the objectives of the entity’s program with respect to individuals with disabilities. . . .” 28 C.F.R. § 35.130(b)(3).
41. The ADA requires state governments and agencies to make reasonable modifications to policies, practices and procedures to avoid discrimination on the basis of disability. 28 C.F.R. § 35.130(b)(7).
VI. MISSOURI’S COVERAGE CRITERIA FOR HEPATITIS C 42. The State of Missouri has elected to participate in the Medicaid program and has designated DSS as the single state Medicaid agency. DSS is a department of state government. 43. The federal government shares the cost of the Missouri Medicaid program by providing funding to the State of Missouri. The federal government pays approximately 63 cents of each dollar spent on Medicaid services in Missouri. 79 Fed. Reg. 71428 (Dec. 2, 2014). 44. The MO HealthNet Division indicated on June 23, 2016 that it “agrees with the AASLD/IDSA recommendation that ALL patients should be treated” and that it welcomes the opportunity for every HCV infected patient to have the chance to be “cured.” 45. However, Defendants have adopted coverage criteria with respect to when and under what conditions it will approve Harvoni and other similar DAAs for coverage under
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Missouri’s Medicaid program that are more restrictive than the national standards of care. Missouri Pharmacy Program Preferred Drug List Hepatitis C Therapy (Effective 8/01/2005, Revised 1/5/2017, http://dss.mo.gov/mhd/cs/pharmacy/pdf/hepatitis-c-therapy.pdf.)
46. Defendants have presented these coverage criteria to the MO HealthNet Oversight Committee, a statutorily-created body that advises Missouri’s Medicaid program. See http://dss.mo.gov/mhd/oversight/pdf/150217-hepatitis-c-therapy.pdf.
47. Defendants do not provide coverage for all Medicaid beneficiaries with HCV. Defendants’ coverage criteria exclude coverage of DAAs for Medicaid enrollees with HCV genotypes 1, 2, and 4 with fibrosis scores of F0, F1 and F2; and exclude coverage of DAAs for Medicaid enrollees with HCV genotype 3 at fibrosis scores of F0 and F1.
48. In January 2017, Defendants reported to the Missouri General Assembly that they have “policies in place that limit treatment to people who have more severe cases of cirrhosis and do not have . . . clinical contraindications to usage.”
49. Defendants report that they have approved “some participants” for coverage of DAAs with fibrosis scores of less than F3 based on other specifics of their condition. Defendants revised these standards on January 5, 2017, to note that: “In addition to Metavir fibrosis score, Clinical Consultant will review all therapy requests for documentation of comorbidities that may result in approval.” http://dss.mo.gov/mhd/oversight/pdf/150217-hepatitis-c-therapy.pdf. The standards do not say which comorbidities will result in approval, however, nor do they allow any other basis for an exception to the fibrosis score requirement.
50. Fibrosis score is not an acceptable medical reason for denying access to medically necessary DAAs. Plaintiffs were denied DAAs because they did not have fibrosis scores of F3 or F4.
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51. Defendants prioritize treatment for Hepatitis C patients who they believe “most urgently need it” rather than provide it to patients for whom such treatment is medically necessary. Defendants’ policy is to “defer” treatment until a patient reaches a more advanced stage of liver disease, as measured by fibrosis requirements. The deferral policy has resulted in Plaintiff J.L.M. waiting over nine months, so far, Plaintiff J.E.M waiting over fourteen months, so far, and Plaintiff H.L.O has waited approximately two months, so far, for coverage.
52. Defendants’ coverage criteria are inconsistent with accepted medical practice. Defendants have no clinical or medical basis to deny treatment to Medicaid enrollees who have a fibrosis score of F0, F1 or F2. On the contrary, the HCV Guidelines provide that “[b]ecause of the myriad benefits associated with successful HCV treatment, clinicians should treat HCVinfected patients with antiviral therapy with the goal of achieving an SVR, preferably early in the course of their chronic HCV infection before the development of severe liver disease and other complications.” See http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy (last visited 5/24/17). Treatment of HCV even in patients with mild or no liver disease decreases complications and death rate due to liver disease and prevents transmission of HCV to others.
53. Medicaid enrollees who meet the standards set forth by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, but who are excluded under Defendants’ coverage criteria, are at risk. They are needlessly exposed to health conditions caused by HCV, including cirrhosis, cancer, fatigue, joint pain, depression, sore muscles, arthritis, avoidable liver transplants, jaundice and even death. In addition, the lack of treatment of infected individuals increases the chance that members of the insured’s household and the public will be exposed to and contract HCV.
54. Previously, Defendants’ authorization criteria also denied DAAs to anyone who
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has tested positive for alcohol or illicit drug use. Patients were required to undergo three months of “abstinence” testing (which means they must test negatively for drug and alcohol use three times over three months) before MO HealthNet would consider an authorization request for DAAs. On February 2, 2017, this Court preliminary enjoined the Defendants from continuing to implement this “abstinence test” requirement. Defendants revised their authorization criteria to remove this abstinence requirement.
55. This abstinence requirement was inconsistent with AASLD/IDSA guidelines, which do not require abstinence as precondition for treatment. This requirement further delayed medically necessary treatment to infected patients, allowing their liver disease to progress unnecessarily, and placing them at additional risk. Denying access to DAAs for individuals who test positive for drug use means that such individuals are more likely to spread the disease through sharing of needles.
56. Defendants’ coverage criteria are not based on requirements of the Medicaid Act. Rather, Defendants’ denial of coverage is an effort to ration care because of its concern over the cost of DAAs. The Defendants’ coverage policies result in long delays for medically necessary services, and they exclude some Medicaid enrollees with HCV from medically necessary DAA treatment while providing the same treatment to other Medicaid enrollees with HCV.
Plaintiffs Require DAAs to Treat Their HCV 57. Plaintiffs are enrolled in the Missouri Medicaid program. Both individuals qualify for Medicaid because they meet requirements of 42 U.S.C. § 1396a(a)(10)(A). 58. Plaintiffs have been diagnosed with HCV. Plaintiffs seek treatment with DAAs, which are recommended for nearly all patients diagnosed with chronic HCV infection by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of
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America, and have been prescribed by their treating physicians. There is no alternative medication or medical intervention that will provide Plaintiffs with equally beneficial results.
Plaintiff J.E.M. 59. J.E.M. is 45 years old and lives alone in Imperial, Missouri. 60. J.E.M. has been diagnosed with Hepatitis C for approximately five years. He also suffers from pancreatitis, spinal osteoarthritis, and high blood pressure. 61. Because of his disabilities, J.E.M. is unable to work. He receives Supplemental Security Income of $733 per month and approximately $190 in food stamps. He has Medicaid coverage based on his disabilities. 62. Because of his Hepatitis C, J.E.M. has experienced a significant decrease in energy and motivation. He is concerned about the possibility of infecting others and takes daily precautions to ensure he does not pass the disease on to others. 63. If he were to attempt to conceive a child, J.E.M. would impose a significant risk of infection on the woman with whom he attempted such conception. J.E.M. takes precautions to avoid conception. 64. J.E.M.’s father recently passed away due to his Hepatitis C and resulting liver cancer. J.E.M. is especially concerned about the effects additional liver damage will have on his life due to this first-hand experience witnessing the impact it had on his father. Because Defendants’ policies require his liver to incur more damage before he can be cured, J.EM. feels he is in a hopeless situation. 65. J.E.M.’s treating physician has prescribed Harvoni to cure his Hepatitis C. J.E.M.’s doctor wrote a prescription to Premier Pharmacy Services on March 3, 2016.
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66. Prescriptions for Harvoni require prior authorization approval from MO HealthNet. However, at the time J.E.M’s doctor wrote the prescription, before MO HealthNet would consider approval, it required three clean “drug screens.”
67. Abstinence from drugs or alcohol is not a condition for the receipt of antiviral drugs according to the standard of care for DAA treatment.
68. J.E.M. underwent urine testing on March 25, 2016; May 19, 2016; and June 16, 2016. All of his tests were “clean,” showing no non-prescription drug or alcohol use.
69. On or about July 6, 2016, Premier submitted a prior authorization request to MO HealthNet for J.E.M.’s Harvoni.
70. On July 6, 2016, MO HealthNet denied this request. 71. MO HealthNet letter sent a letter to J.E.M. stating that the request was denied because “the information submitted did not meet the criteria established to obtain authorization for this drug.” 72. A denial notice sent to J.E.M.’s doctor stated that “the patient does not meet Mo HealthNet’s criteria for a fibrosis score of F3 or greater. The patient’s fibrosis score is F2 [F1F2].” 73. MO HealthNet did not offer J.E.M. any other medication as an alternative to treat his Hepatitis C. 74. Waiting for his fibrosis to progress from F2 to F3 means J.E.M. will have to incur further irreversible organ damage before his disease can be cured.
Plaintiff J.L.M. 75. Plaintiff J.L.M. is 36 years old and lives with her two teenage daughters in Foley, Missouri.
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76. J.L.M. was diagnosed with Hepatitis C in April 2016. She also has a diagnosis of fibromyalgia.
77. Because of her disabilities, J.L.M. is unable to work. She is a widow and receives $768 in Social Security survivor’s benefits each month. J.L.M. is covered by Medicaid based on her disabilities.
78. Because of her Hepatitis C, J.L.M.’s fibromyalgia has worsened, and she experiences frequent pain and fatigue. Her preexisting anxiety has also increased significantly.
79. J.L.M. underwent a tubal ligation to prevent pregnancy. If she reversed her tubal ligation to conceive a child, she would impose a significant risk of infection on her partner, and on any child she conceived.
80. J.LM. lives in constant fear of inadvertently infecting her children. She takes many safety precautions in her home, including bleaching her bathtub each time she shaves her legs. She is also afraid of infecting strangers and worries about what might happen if she were hurt in public and a stranger stopped to help her and then also became infected. J.L.M. is reluctant to leave her home because she is afraid of putting others in danger.
81. J.L.M.’s treating nurse practitioner has prescribed Epclusa to cure her Hepatitis C. J.L.M.’s nurse practitioner wrote a prescription to Walgreens Specialty Pharmacy on July 19, 2016.
82. Prescriptions for Epclusa require prior authorization approval from MO HealthNet. Walgreens submitted a prior authorization request to MO HealthNet for J.L.M.’s Epclusa.
83. J.L.M. underwent urine testing on June 8, 2016; July 7, 2016; and July 22, 2016. All of her tests were “clean,” showing no non-prescription drug or alcohol use.
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84. On August 26, 2016 MO HealthNet denied the prior authorization request for Epclusa.
85. J.L.M. did not receive a letter explaining the reason for this denial. 86. Walgreens sent a fax to J.L.M.’s doctor that stated the request was “denied Epclusa due to low F-score. At this point there are no other options in which to proceed as she has MO Medicaid. She will need to advance to F3/F4 in order for MO Medicaid to approve her.” 87. A denial notice sent to J.L.M.’s nurse practitioner stated that “the patient does not meet Mo HealthNet’s criteria for a fibrosis score of F3 or greater. The patient’s fibrosis score is F0.” 88. MO HealthNet did not offer any other medication as an alternative to treat her Hepatitis C. 89. Waiting for her fibrosis to progress from F0 to F3 means that J.L.M. will have to incur further irreversible organ damage before her disease can be cured.
Plaintiff H.L.O. 90. Plaintiff H.L.O. is a 27 year old Medicaid recipient living with her three children in Belton, Missouri. 91. H.L.O. is a single mother of three children, ages five, six and nine. She survives on $200 a month in child support and financial assistance from her mother. 92. H.L.O. was diagnosed with Hepatitis C early in 2017. Her fibrosis score is F0. She has no other diseases. 93. H.L.O. suffers pain in her abdomen frequently.
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94. H.L.O. is constantly anxious about the risk that her children will be infected with Hepatitis C. She has to ensure that her children don’t touch her tooth brush, razor, or other personal hygiene items. She and the children use hand sanitizer often throughout the day.
95. If H.L.O. attempted to conceive another child, she would impose a significant risk of infection on her partner, and on any child she conceived. H.L.O takes precautions to avoid conception.
96. H.L.O.’s doctor has prescribed Viekira Pak for her, a drug combination that will likely cure her Hepatitis C. On April 11, 2017, MO HealthNet sent H.L.O.’s doctor a notice indicating that his request for prior authorization “could not be processed at this time” without any explanation. Later that same day, MO HealthNet denied her doctor’s request for a prior authorization MO HealthNet for Viekira Pak. The denial notice simply stated, “The patient does not meet MO HealthNet’s criteria.” On April 25, 2017, MO HealthNet denied her doctor’s request for prior authorization a second time, stating the same reason. On May 10, 2017, the MO HealthNet Division sent another notice to her doctor indicating that H.L.O.’s request for prior authorization “could not be processed at this time” because the “patient does not meet MO HealthNet’s criteria.” On May 12, 2017, MO HealthNet again denied her doctor’s request for prior authorization, providing the same rationale for the denial. MO HealthNet did not offer H.LO. any other medication as an alternative to treat her Hepatitis C.
Other Plaintiff Facts 97. Treatment with DAAs is “medically necessary” for Plaintiffs and others, as determined by their treating physicians, and is consistent with the standard of care in the medical community. 98. Defendants take the position that Plaintiffs’ treatment may be delayed until a
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fibrosis score of F3 or F4 is reached. This position is inconsistent with clinical studies of HCV treatments, the AASLD/IDSA Treatment Recommendations and the standard of care for treatment of HCV in Missouri.
99. Defendants’ authorization criteria permit exceptions to its fibrosis score requirement, but do not state the criteria that will be used to evaluate exceptions, or explain when an exception request will be approved. The authorization criteria allow some individuals with a fibrosis score lower than F3 to obtain treatment based on unnamed comorbidities, but do not allow other individuals without these comorbidities to obtain treatment.
100. Defendants’ notices also do not explain the reason that Plaintiffs’ requests for DAA treatment were denied, nor do they provide the factual or legal basis for the denial. They merely state that Plaintiffs did “not meet the criteria established to obtain authorization for this drug.”
101. At all times relevant, Defendants have acted under color of state law in failing and refusing to provide coverage of medically necessary DAAs for Plaintiffs.
102. There is no plain, adequate, or complete remedy at law to prevent or redress the harm suffered by Plaintiffs as a result of Defendants’ failure and refusal to provide coverage of medically necessary Hepatitis C drugs.
103. Plaintiffs are suffering and will suffer irreparable harm as a result of Defendants’ ongoing unlawful failure to cover medically necessary drugs for treating Hepatitis C.
VII. CLAIMS FOR RELIEF First Claim for Relief: Violations of Medicaid Entitlement to Appropriate Amount,
Duration, and Scope of Treatment 104. Plaintiffs restate and incorporate by reference paragraphs 1 through 103 above.
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105. Plaintiffs are entitled to declaratory and injunctive relief pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 because Defendants are violating Title XIX of the Social Security Act by excluding Medicaid beneficiaries from medically necessary treatment as required by 42 U.S.C. §§ 1396a(a)(10)(A) and 1396d(a)(12).
Second Claim for Relief: Violations of Medicaid Comparability 106. Plaintiffs restate and incorporate by reference paragraphs 1 through 105 above. 107. Plaintiffs are entitled to declaratory and injunctive relief pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 because Defendants, by discriminating among similarly situated Medicaid beneficiaries on the basis of categorical restrictions that are not based upon prevailing clinical standards, are violating Medicaid Act comparability requirements, 42 U.S.C. § 1396a(a)(10)(B)(i).
Third Claim for Relief: Violations of Reasonable Promptness 108. Plaintiffs restate and incorporate by reference paragraphs 1 through 107 above. 109. Plaintiffs are entitled to declaratory and injunctive relief pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 because Defendants are violating the “reasonable promptness” requirement of Title XIX of the Social Security Act, 42 U.S.C. § 1396a(a)(8), by implementing a policy that de facto rations coverage for Medicaid enrollees seeking HCV treatment, thereby requiring Plaintiffs and those like them to wait until they have developed severe liver damage before receiving medically necessary treatment.
Fourth Claim for Relief: Ascertainable Standards 110. Plaintiffs restate and incorporate by reference paragraphs 1 through 109 above.
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111. In order to comply with due process, a State Medicaid program must use reasonable, ascertainable, non-arbitrary standards and procedures for determining eligibility for and the extent of medical assistance provided.
112. Defendants’ authorization criteria for DAAs use vague, subjective, arbitrary and secret criteria and procedures for determining which Medicaid beneficiaries with HCV will receive DAA treatment. Defendants’ authorization criteria for DAAs are therefore inconsistent with the Due Process Clause of the Fourteenth Amendment to the U.S. Constitution.
Fifth Claim for Relief: Procedural Due Process 113. Plaintiffs restate and incorporate by reference paragraphs 1 through 112 above. 114. In order to comply with due process, when it denies a beneficiary a requested service, a State Medicaid program must provide notice provides the reason for the denial and the specific laws or regulations that support the agency’s decision. 115. Defendants’ notices that deny Plaintiffs’ access to DAA treatment because they “do not meet criteria” violates Plaintiffs’ due process rights under the Federal Medicaid Act pursuant to 42 U.S.C. § 1396a(a)(3) and under the Due Process Clause of Fourteenth Amendment to the U.S. Constitution, enforceable pursuant to 42 U.S.C. § 1983.
Sixth Claim for Relief: Americans with Disabilities Act 116. Plaintiffs restate and incorporate by reference paragraphs 1 through 115 above. 117. Each of the Plaintiffs is a “qualified individual with a disability” within the meaning of 42 U.S.C. § 12131(2). Each of the Plaintiffs has a disability that significantly limits his or her life activities including the ability to reproduce, and other major life activities. 118. Defendants’ policy of not providing DAA treatment to Plaintiffs treats them differently than other qualified people with disabilities, based solely on the severity of their
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disability. It therefore violates the Americans with Disabilities Act, 42 U.S.C. § 12131-12134, and its implementing regulations, which prohibit discrimination on the basis of disability, and requires that reasonable modifications be made to state programs to avoid discrimination on the basis of disability.
REQUEST FOR RELIEF A. Assume jurisdiction over this action; B. Issue a declaratory judgment holding that Defendants may not apply policies or practices that exclude or impermissibly limit treatment of HCV with Harvoni, Epclusa, Viekira Pak, or other similar DAAs pursuant to coverage criteria that are inconsistent with the current AASLD/IDSA Treatment Guidelines; C. Grant preliminary and permanent injunctions that prohibit Defendants from implementing and enforcing the current HCV Treatment Policy (dated October 1, 2015) or otherwise impermissibly limiting access to medically necessary DAAs, and from refusing to provide Medicaid coverage of medically necessary Hepatitis C drugs for Plaintiffs as determined by their physicians; D. Require Defendants to provide corrective notice to all Medicaid beneficiaries including Plaintiffs, denied coverage under DSS’s current HCV Treatment Policy, informing them of a state-based procedure that will be developed, implemented, and available to them for determining whether they qualify for DAAs pursuant to revised criteria that are consistent with the current AASLD/IDSA Treatment Guidelines; E. Award Plaintiffs their reasonable attorneys’ fees and costs; and F. Grant such other and further relief as may be just and proper.
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Respectfully submitted,
/s/ Joel Ferber Joel Ferber # 35165 Jamie L. Rodriguez # 64323 Legal Services of Eastern Missouri, Inc. 4232 Forest Park Avenue St. Louis, Missouri 63108 (314) 534-4200 telephone (314) 534-1028 facsimile jdferber@lsem.org jlrodriguez@lsem.org
/s/ John J. Ammann John J. Ammann # 34308 Saint Louis University Legal Clinic 321 N. Spring Street St. Louis, Missouri 63108 (314) 977-2778 telephone (314) 977-1180 facsimile ammannjj@slu.edu
/s/ Abigail K. Coursolle Abigail K. Coursolle M. Jane Perkins National Health Law Program, Inc. 3701 Wilshire Blvd, Suite #750 Los Angeles, CA 90010 (310) 204-6010, Ext. 107 telephone (213) 368-0774 facsimile coursolle@healthlaw.org perkins@healthlaw.org
ATTORNEYS FOR PLAINTIFFS
CERTIFICATE OF SERVICE
The undersigned hereby certifies that a copy of the foregoing was filed electronically with the Clerk of Court on June 6, 2017, to be served by operation of the Court’s electronic filing system upon all parties.
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/s/ Joel Ferber
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 IN THE UNITED STATES DISTRICT COURT WESTERN DISTRICT OF MISSOURI CENTRAL DIVISION

J.E.M., et al., v.

Plaintiffs,

STEVEN CORSI, in his official capacity as Director of the Missouri Department of Social Services, et al.,
Defendants.

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Case No. 16-cv-04273-SRB

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ORDER

Before the Court is Defendants’ Motion to Dismiss Plaintiffs’ Amended Complaint.

(Doc. #74). For the reasons stated below, the motion is denied.

I. Background

On February 2, 2017, the Court issued an order denying Defendants’ motion to dismiss

Plaintiffs’ original complaint, filed against Defendant Brian Kinkade in his official capacity as

Director of the Missouri Department of Social Services (“MDSS”), and Joe Parks, M.D., in his

official capacity as Director of the MO HealthNet Division (“MHD”), alleging that Defendants’

denial of direct-acting antiviral treatment (‘DAAs”) to some Missouri Medicaid beneficiaries

with Hepatitis C (“HCV”) violates the Medicaid Act. (Doc. #41). That Order and the Court’s

other prior orders set forth the facts of this action, familiarity with which is presumed.

On the same day, the Court also issued an order granting, in part, Plaintiffs' motion for

preliminary injunction and enjoining Defendants from requiring three months of negative drug

and alcohol screens prior to submitting requests for DAA approval. (Doc. #40). Defendants

subsequently revised their authorization criteria to remove the abstinence requirement. (Doc.

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#74, p. 10). On March 10, 2017, the Court held an evidentiary hearing on the medical necessity of treating all HCV patients with DAAs, regardless of their fibrosis score. After considering the record and evidence submitted at the hearing, the Court issued an order on April 24, 2017, denying the remainder of the requested preliminary injunction, determining that Plaintiffs had not established their entitlement to a preliminary injunction prohibiting Defendants from considering fibrosis scores in deciding whether to approve DAA treatments. (Doc. #61).
On June 6, 2017, original plaintiffs J.E.M. and J.L.M., filed an amended complaint, which added plaintiff, H.L.O., and two more claims arising from the same contention that Defendants are improperly refusing DAAs to chronic HCV sufferers who do not have a fibrosis score of F3 or higher. The amended complaint includes six claims for relief: 1) a 42 U.S.C. § 1983 claim for failure to provide medically-necessary prescription drugs in violation of 42 U.S.C. §§ 1396a(a)(10)(A) and 1396(d)(a)(12); 2) a 42 U.S.C. § 1983 claim for violation of the Medicaid Act’s “comparability” requirement at 42 U.S.C. § 1396a(a)(10)(B)(i); 3) a 42 U.S.C. § 1983 claim for violation of the Medicaid Act’s “reasonable promptness” requirement at 42 U.S.C. § 1396a(a)(8); 4) violation of the 14th Amendment Due Process Clause for the lack of "ascertainable standards" regarding which beneficiaries will receive DAAs; 5) a 42 U.S.C. § 1983 claim for violation of Plaintiffs’ procedural due process rights pursuant to 42 U.S.C. § 1396a(a)(3) based on inadequate denial notices; and 6) a claim for violation of the ADA, 42 U.S.C. §§ 12131-12134, and its implementing regulations, for differential treatment of Plaintiffs from other qualified people with disabilities. Defendant Steven Corsi, the new Director of the MDSS, has since been substituted for his predecessors by consent of the parties. (Doc. #61, p. 6).
Defendants now move to dismiss Counts I, II, III, IV, and VI of the amended complaint (constituting all claims except for the alleged violation of Plaintiffs' due process rights due to the
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failure to provide notices adequately explaining MHD’s denial of prior authorization for DAAs). In support of dismissing Counts I-IV, Defendants argue that Plaintiffs are actually relying on another provision of the Medicaid Act, 42 U.S.C. § 1396r-8, and that Plaintiffs have deliberately excluded § 1396r-8 from the complaint to end run their inability to privately enforce it under § 1983. Defendants also contend that Count VI, which asserts a claim for differential treatment of Plaintiffs in comparison to other HCV patients, is duplicative of Plaintiffs' "comparability claim," and is in effect, a challenge to utilization control procedures that must fail because 42 U.S.C. § 1396r-8 is not privately enforceable. Plaintiffs argue that the Court has previously rejected these arguments, and in filing this motion, Defendants are ignoring basic pleading rules that allow plaintiffs to retain control over their pleadings and select their own claims.
II. Legal Standard Pursuant to Fed. R. Civ. P. 12(b)(6), a claim may be dismissed for “failure to state a claim upon which relief can be granted.” The Court must consider all facts alleged in the Complaint as true when considering a motion to dismiss. See Data Mfg., Inc. v. United Parcel Service, Inc., 557 F.3d 849, 851 (8th Cir. 2009) (noting “[t]he factual allegations of a complaint are assumed true and construed in favor of the plaintiff, even if it strikes a savvy judge that actual proof of those facts is improbable”). “To survive a motion to dismiss [for failure to state a claim], 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 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)) (internal citations omitted); Zink v. Lombardi, 783 F.3d 1089, 1098 (8th Cir. 2015). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the
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defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678; Ash v. Anderson
Merchs., LLC, No. 14–3258, 2015 WL 4978701, at *1 (8th Cir. 2015).
III. Discussion
a. Court Cannot Construe Claims as § 1396r-8 Challenge
Defendants recapitulate the arguments made in their prior motion to dismiss, which the
Court previously rejected as follows:
The Court agrees with Plaintiffs that they are the “masters of their complaint” and may choose their causes of action. See Johnson v. MFA Petroleum Co., 701 F.3d 243, 247 (8th Cir. 2012) (stating plaintiff may avoid federal jurisdiction by choosing to allege only state-law claims). Furthermore, Defendants mischaracterize Plaintiffs’ allegations. Plaintiffs do not allege that the challenged Approval Criteria are merely “unreasonable.” Rather, Plaintiffs allege that the challenged Approval Criteria are illegal and in effect deny, rather than just restrict, medically necessary treatment to Missouri Medicaid patients with HCV. (Doc. #1, ¶37). While Defendants challenge Plaintiffs’ allegations, these factual challenges are not appropriate considerations at the motion to dismiss stage.
(Doc. #41, p. 2). The Court finds that this reasoning extends to the subject claims. Defendants’
prior motion was predicated on similar arguments that Plaintiffs should have asserted their
claims under another provision of the Medicaid Act— in the first motion, the "reasonable-
standards requirement" of 42 U.S.C. § 1396a(a)(17), and in the instant motion, 42 U.S.C.
§ 1396r-8 regulations for the prior authorization and rebate coverage of outpatient drugs—for which Defendants argue no individualized right to enforce under 42 U.S.C. § 1983 exists.1
Defendants do not distinguish why the Court’s rationale does not apply here.
“Under the well-pleaded complaint rule, the court allows plaintiff to be master of the
complaint, giving deference to the specific claims which plaintiff has brought and accepting that
1 The Court makes no determination as to whether 42 U.S.C. § 1396r-8 confers a private right of action under the test stated in Blessing v. Freestone, 520 U.S. 329, 340 (1997). The Court recognizes, however, that this Circuit has held that the “reasonable standards” requirement of 42 U.S.C. § 1396a(a)(17) is not privately enforceable, and that a §1983 claim brought under that statute would fail. Lankford v. Sherman, 451 F.3d 496, 509 (8th Cir. 2006).
4
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plaintiff has purposefully avoided those otherwise-actionable claims not alleged.” Henderson v. Vill. of Dixmoor, 99 F. Supp. 2d 940, 943 (N.D. Ill. 2000), aff'd sub nom. Henderson v. Bolanda, 253 F.3d 928 (7th Cir. 2001). As masters of their own complaint, Plaintiffs are permitted to exclude otherwise-actionable claims, plead different legal theories that are supported by the facts, and invoke statutes that are individually enforceable under § 1983. Moreover, the inclusion of allegations that support enforceable Medicaid claims does not “convert” these claims into privately unenforceable ones under the Medicaid Act. See O.B. v. Norwood, 170 F. Supp. 3d 1186, 1193 (N.D. Ill.), aff'd, 838 F.3d 837 (7th Cir. 2016) (court denied motion to dismiss privately enforceable EPSDT and "reasonable promptness" claims, rejecting defendant’s argument that such claims should be dismissed when plaintiffs did not cite proper reimbursement rates provision to circumvent prohibition on its private enforcement under § 1983).
Consequently, the Court rejects Defendants’ arguments that Counts I-IV and VI should be “[c]onsidered through the prism” of 42 U.S.C. § 1396r-8 and be dismissed as privately unenforceable. The Court cannot read § 1396r-8 into Plaintiffs’ claims, when Plaintiffs have not specifically pled a claim under this provision. See, e.g., Henderson, 99 F. Supp. 2d at 943 (“Although the actions …could have given rise to claims under § 1983, the court cannot simply choose to read a separate legal theory into plaintiffs' complaint.”); Wolfe v. Tackett, No. CIV.A. 2:08-01114, 2009 WL 973442, at *5 (S.D.W. Va. Apr. 9, 2009) (“simply because [plaintiff] could have brought a claim under § 1983, does not mean that he did”). Because it is improper for the Court to read into the complaint legal theories that are not asserted, the Court will not construe Plaintiffs’ availability, comparability, reasonable promptness, ascertainable standards, and ADA claims as a challenge to MHD’s utilization control procedures under § 1396r-8.
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Additionally, Defendants do not refer the Court to any valid authority holding that Counts I-IV and VI are precluded or preempted by § 1396r-8’s enforcement scheme2, or that Plaintiffs’ claims do not implicate a private right of action or cannot be asserted as stand-alone claims. In fact, a review of Medicaid cases decided in this jurisdiction suggests the contrary. See, e.g., Lankford, 451 F.3d 496 (Missouri durable medical equipment benefit did not violate the “comparability” requirement, which was permissibly, privately contested through § 1983); Guggenberger v. Minnesota, 198 F. Supp. 3d 973 (D. Minn. 2016) (plaintiffs could assert—and prevailed—on a § 1983 claim that Minnesota violated “reasonable promptness” requirement by placing developmentally disabled Medicaid recipients on waitlist for waiver services); Weaver v. Reagen, 886 F.2d 194 (8th Cir. 1989) (in § 1983 suit, court evaluated whether Missouri’s AZT coverage for Medicaid AIDS patients was sufficient in amount, duration, and scope).
Because the Court declines to treat Counts I-IV and VI as a § 1396r-8 challenge to MHD’s prior authorization procedures, the Court does not find that the subject claims are unenforceable under § 1983. Thus, the motion to dismiss is denied on these grounds.
b. Ascertainable Standards and ADA Discrimination Claims Defendants also argue that Plaintiffs' ascertainable standards claim under the Fourteenth Amendment (Count IV), and claim for relief under the ADA (Count VI), both fail to state a claim as a matter of law. Defendants’ arguments with respect to both claims are unavailing. The parties agree that the standard for determining a 14th Amendment violation is the “absence of any ascertainable standard for inclusion and exclusion.” Smith v. Goguen, 415 U.S. 566, 578 (1974). Defendants contend that “Plaintiffs can prove no violation of the Fourteenth
2 Defendants cite Blessing for their proposition that prescription drug benefits are exclusively subject to the regulatory framework of § 1396r-8. (Doc. #91, p. 7). Blessing considers the separate issue of whether a federal statute creates an individual right, involving factually dissimilar claims under Title IV-D of the Social Security Act; Blessing does not hold that § 1396r-8 forecloses other claims, and is therefore inapposite. 520 U.S. 329.
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Amendment” because MHD’s eight-page, published criteria provides information on its review of therapy requests, its Clinical Consultant’s consideration of documented comorbidities, and a participant’s right to request state fair hearings. (Doc. #84, pp.17-18; Doc. #91, pp. 8-9). These arguments cut to the heart of the substantive merits of Plaintiffs’ claim, i.e. whether the approval criteria are “ascertainable,” rather than analyzing whether Plaintiffs have stated a facially plausible claim. Because Defendants do not address whether this claim is adequately pled under Rule 12(b)(6), and instead attack the merits of the claim, the motion is denied as to Count IV.
In pleading their ADA claim, Plaintiffs refer to Title II of the ADA, 42 U.S.C. § 12131 et seq., which “prohibits qualified individuals with disabilities from being excluded from participation in or the benefits of the services, programs, or activities of a public entity.” Randolph v. Rodgers, 170 F.3d 850, 858 (8th Cir. 1999). To state a prima facie claim under Title II of the ADA, a plaintiff must show: 1) he is a person with a disability as defined by statute; 2) he is otherwise qualified for the benefit in question; and 3) he was excluded from the benefit due to discrimination based upon disability. Id. The Court finds that Plaintiffs pled sufficient factual matter to state a facially plausible ADA claim, and allege the required elements by stating that they are qualified as people with disabilities under the ADA, are otherwise qualified for DAA treatment, and were excluded from treatment because of the severity of their disability,
Defendants argue that Count VI is barred because an ADA suit cannot be based on medical treatment decisions. Burger v. Bloomberg, 418 F.3d 882, 883 (8th Cir. 2005). However, the courts in this district have distinguished Defendants’ authorities from the circumstances of this case. In Postawko v. Missouri Dep't of Corr., No. 2:16-CV-04219-NKL, 2017 WL 1968317, at *13 (W.D. Mo. May 11, 2017), which involves a strikingly similar challenge to the denial of DAA drug treatments to HCV-infected inmates by the Missouri
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Department of Corrections, the court determined that plaintiffs stated a plausible ADA discrimination claim. In so concluding, the court distinguished the cases cited by Defendant from the suit before it, stating that cases barring ADA medical treatment “involve situations where individual plaintiffs simply disagreed with medical treatment decisions and did not challenge a prison's general policy or custom[.]” Id. (distinguishing Dinkins v. Mo. Dep't of Corrs., 743 F.3d 633, 634 (8th Cir. 2014), which held dismissal of ADA claims was proper where inmate challenged individual medical decisions relating to the diagnosis and treatment of his pernicious anemia, rather than a general policy). The distinction defined in Postawko applies to the within case. Here, Plaintiffs contest Defendants’ general policy of denying DAAs to a class of HCV patients, based on their low fibrosis scores and lack of qualifying comorbidities, rather than individual treatment decisions or malpractice committed by their medical providers. Accordingly, Plaintiffs are not barred from bringing Count VI, and the motion to dismiss this claim is denied.
IV. Conclusion In view of the foregoing, Defendants’ Motion to Dismiss Plaintiffs’ Amended Complaint. (Doc. #74) is hereby DENIED. IT IS SO ORDERED.

Dated: July 21, 2017

/s/ Stephen R. Bough STEPHEN R. BOUGH UNITED STATES DISTRICT JUDGE

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