Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 1 of 16 1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON AT SEATTLE 9 10 11 B. E. and A. R., on their own behalf and on behalf of all similarly situated individuals, 12 13 14 15 16 NO. 2:16-cv-227 Plaintiffs, v. DOROTHY F. TEETER, in her official capacity as Director of the Washington State Health Care Authority, COMPLAINT (CLASS ACTION) Defendant. 17 I. 18 INTRODUCTION 19 Plaintiffs are Medicaid enrollees who have contracted Hepatitis C, a 20 communicable disease that afflicts millions of Americans. There is a cure for Plaintiffs 21 and thousands of others, but the Washington State Health Care Authority does not cover 22 curative, breakthrough drugs for all Medicaid beneficiaries for one impermissible 23 reason: they are expensive. It is unlawful to withhold prescription drugs that cure a 24 disease from Medicaid beneficiaries based on the cost of those drugs. Plaintiffs ask this 25 Court to order the Health Care Authority to cover these drugs so they and others 26 similarly situated may be cured. COMPLAINT (CLASS ACTION) – 1 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 2 of 16 II. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 1. B.E. Plaintiff B.E. is a resident of Seattle, Washington. Ms. E. is eligible for and enrolled in Medicaid, which is administered by the Washington state Health Care Authority (“WHCA”). Ms. E. is diagnosed with Hepatitis C virus (“HCV”). Her treating provider prescribed Harvoni®, ledipasvir-sofosbuvir (“Harvoni”), a prescription drug that effectively cures the disease in more than 90% of the individuals who are treated with it. When she attempted to fill her prescription through her Medicaid coverage, WHCA denied Ms. E.’s request because Harvoni is expensive. WHCA did not offer Ms. E. any other medication as an alternative to treat her HCV. 2. A.R. Plaintiff A.R. is a resident of Lakewood, Washington. Mr. R. is also eligible for and enrolled in Medicaid. He is also diagnosed with HCV for which his treating medical provider has prescribed Harvoni. WHCA also denied Mr. R.’s request for Harvoni for the same reason it denied B.E.’s request. WHCA did not offer Mr. R. any other medication as an alternative to treat his HCV. 3. Dorothy F. Teeter. Defendant Dorothy F. Teeter is the Director of the Washington State Health Care Authority. WHCA is the designated single state agency for Washington’s Medicaid programs. Ms. Teeter is responsible for ensuring that the Medicaid program is administered in a manner consistent with all state and federal laws, including the Medicaid Act. Ms. Teeter is sued in her official capacity only. All alleged acts by Ms. Teeter and WHCA were made under color of state law. III. JURISDICTION AND VENUE 21 22 23 24 25 26 PARTIES 4. Jurisdiction. Jurisdiction of this Court arises under 28 U.S.C. § 1331 because this action arises under the laws of the United States, and 28 U.S.C. § 1343(3) and (4), which confer on the federal district courts original jurisdiction over all claims asserted pursuant to 42 U.S.C. § 1983 to redress deprivations of rights, privileges or immunities guaranteed by Acts of Congress and the United States Constitution. COMPLAINT (CLASS ACTION) – 2 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 3 of 16 5. 1 Venue. Venue is proper pursuant to 28 U.S.C. § 1391(b). A substantial part 2 of the events or omissions giving rise to plaintiffs’ claims occurred in the Western District 3 of Washington, and defendants may be found here. 4 IV. NATURE OF THE CASE 6. 5 Plaintiffs’ Need for Treatment with Harvoni. Both Ms. E. and Mr. R. have 6 been diagnosed with Hepatitis C (“HCV”). Both seek treatment with Harvoni, one of 7 several direct-acting antiviral medications (“DAAs”) recommended for nearly all 8 patients diagnosed with chronic HCV infection by the American Association for the 9 Study of Liver Diseases and the Infectious Diseases Society of America. Treatment 10 results in a more than 90% cure rate. There is no alternative medication or medical 11 intervention that would provide Ms. E. or Mr. R. with equally beneficial results. 7. 12 WHCA Limits Coverage for Harvoni and other DAAs for Fiscal Reasons 13 Only. WHCA, pursuant to a uniform coverage policy, will not approve plaintiffs’ 14 treatment with Harvoni. WHCA has put in place internal coverage restrictions that 15 impermissibly restrict DAA coverage. Specifically, WHCA rations HCV treatment, 16 excluding all coverage except to its insureds who are most severely ill. The restrictions 17 on coverage do not have a clinical purpose, but are imposed solely due to WHCA’s fiscal 18 concerns. 8. 19 WHCA’s Uniform Policy Risks the Lives and Health of Medicaid 20 Enrollees. WHCA’s restrictive internal coverage criteria require that infected 21 individuals wait for treatment – potentially for years – until they demonstrate serious 22 scarring or cirrhosis of the liver from HCV infection. In the meantime, Ms. E., Mr. R. and 23 others are forced to live with a chronic inflammatory disease, including the pain, fatigue, 24 depression, deteriorating health and increased risk of cancer and death that accompany 25 it. 26 COMPLAINT (CLASS ACTION) – 3 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 4 of 16 1 9. WHCA’s Restrictive Coverage Criteria Violate the Medicaid Act. This 2 lawsuit seeks to end WHCA’s improper exclusion of Harvoni and other DAAs for the 3 treatment of HCV for certain enrollees. It seeks legal and equitable remedies against 4 WHCA on behalf of plaintiffs and the class they seek to represent. It also seeks a court 5 order declaring WHCA’s internal categorical exclusionary criteria illegal, void, and 6 inconsistent with its obligations to provide reasonably prompt coverage of medically 7 necessary prescription drugs to all Medicaid enrollees to whom they are prescribed. The 8 lawsuit further seeks an injunction to prevent any future or ongoing efforts by WHCA 9 to use and enforce any policies or practices that impermissibly deny, exclude or limit its 10 insureds’ access to medically necessary prescription drugs to treat HCV, in addition to 11 ensuring that both coverage and corrective notice be provided to its insureds. 12 V. FACTUAL AND LEGAL FRAMEWORK 13 14 HCV TREATMENT 10. HCV Is Widespread. HCV is a chronic, life-threatening, communicable, 15 blood-borne viral disease. It is estimated that approximately five million individuals in 16 the United States are living with HCV, accounting for over 1% of the population. The 17 Washington Department of Health estimates over 100,000 Washington residents are 18 infected with HCV. 19 11. HCV Is a Serious Disease. In addition to the baseline manifestation of 20 chronic inflammation throughout the body, HCV can lead to severe liver damage, 21 infections, liver cancer, and death. Nearly 20,000 people in the United States die each 22 year due to liver disease caused by HCV. 23 Statistics/index.htm (last visited 1/25/16). Even before the advanced stages of the 24 disease, individuals with HCV can suffer from heart attacks, fatigue, joint pain, 25 depression, sore muscles, arthritis and jaundice. Statistics from the Centers for Disease 26 Control and Prevention indicate that up to 70% of those with HCV will develop chronic COMPLAINT (CLASS ACTION) – 4 See http://www.cdc.gov/hepatitis/ SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 5 of 16 1 liver disease, 20% will develop cirrhosis, and 5% will develop liver cancer. HCV is the 2 leading 3 http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm (last visited 2/3/16). 4 12. indication for liver transplants in the United States. See Severity of HCV Is Measured by a Fibrosis Score. Liver health for those 5 who are infected with HCV is graded according to the level of liver scarring under a 6 fibrosis score. The scoring ranges from a score of F0 (mild scarring or scarring absent) 7 to F4 (significant liver damage; cirrhosis). 8 13. Prior Treatments Were Expensive, Often Ineffective and Accompanied by 9 Significant Side Effects. Until DAAs were approved, the standard of care for the 10 treatment of HCV was a three-drug treatment containing boceprevir, interferon and 11 ribavirin. The treatment only provided at most a 70% cure rate, and was accompanied 12 by significant adverse side effects such as anemia, insomnia, anxiety, depression, nausea, 13 bone pain, muscle, liver failure, joint pain, memory loss and death. On information and 14 belief, WHCA covered the three-drug treatment for any Medicaid beneficiary who was 15 HCV irrespective of the person’s Metavir Fibrosis score. 16 14. FDA Approves Harvoni and other DAAs as a “Breakthrough Therapy.” 17 Fortunately for Ms. E., Mr. R. and others like them, the federal Food and Drug 18 Administration (“FDA”) has approved DAAs, a class of curative pharmaceutical drug 19 treatments for HCV. One such DAA, Harvoni, was approved on October 10, 2014. It 20 has a success rate over 90% and is accompanied by few, if any, side effects. Harvoni was 21 designated a “breakthrough therapy” by the FDA, a classification reserved for drugs that 22 have proven to provide substantial improvement over available therapies for patients 23 with serious or life-threatening diseases. 24 15. Harvoni and Other DAAs Are Recommended for Nearly All Patients with 25 HCV, Without Regard for Fibrosis Score. Harvoni and other DAAs are the standard of 26 medical care for the treatment of all HCV. This includes treatment of all individuals COMPLAINT (CLASS ACTION) – 5 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 6 of 16 1 irrespective of fibrosis score. 2 Association for the Study of Liver Diseases and the Infectious Diseases Society of 3 America (“AASLD/IDSA”) confirm that Harvoni and other DAAs should not be 4 reserved 5 http://hcvguidelines.org/ (last visited 1/25/16). Rather, the standard of care is treating 6 “all patients with chronic HCV infection, except those with short life expectancies that 7 cannot be remediated by treated HCV, by transplantation, or by other directed therapy.” 8 See http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy (last 9 visited 1/25/16). Treating nearly all HCV patients is the standard of care in the 10 11 for only Treatment guidelines approved by the American individuals with fibrosis scores of F3 and F4. See community. 16. There Is No Equally Effective Alternative Medication or Medical 12 Intervention. DAAs are the only medication or medical intervention for HCV that 13 produce a sustained virologic response (“SVR”) in more than 90% of patients. SVR 14 status means that the virus is virtually undetectable in a patient; this is considered to be 15 a cure of the infection. The prior intervention offered to HCV patients, treatment with 16 boceprevir, interferon and ribavirin, only produced SVR in approximately 70% of 17 patients, resulted in a host of adverse side effects. Without treatment, Medicaid enrollees 18 infected with chronic HCV will never rid themselves of the inflammatory disease, 19 placing these Medicaid enrollees at significantly higher risk for extrahepatic symptoms, 20 liver disease, liver cancer, and even death. 21 17. People with HCV Can Transmit It. HCV is a communicable disease. The 22 CDC lists people known to be at increased risk for HCV infection. See 23 http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm (last visited 2/3/16). Among those at 24 risk are health care workers after needle-sticks involving HCV-positive blood, and 25 infants born to HCV-positive mothers. WHCA’s policy of restricting DAAs ignores the 26 public health risks associated with not curing HCV. COMPLAINT (CLASS ACTION) – 6 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 7 of 16 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 THE MEDICAID ACT REQUIRES COVERAGE OF DAAs TO TREAT HCV. 18. The Medicaid Act Includes Prescription Drug Coverage. The Medicaid Act requires participating state programs (known as “State Medicaid Plans”) to make medical assistance available to qualified individuals for certain services. 42 U.S.C. § 1396a(a)(10)(A). The State Medicaid Plan has the option to make medical assistance available for other specified services, including prescription drugs. 42 U.S.C. § 1396d(a)(12). Once the state chooses to provide medical assistance prescription drugs, it must comply with the requirements of § 1396r–8(k) for payments of covered outpatient drugs. 42 U.S.C. § 1396a(a)(54). Washington state has chosen to provide prescription drug coverage as part of its State Medicaid Plan. 19. All of the Requirements for Coverage Of DAAs Under Washington’s State Medicaid Plan Are Met. State Medicaid plans, including Washington’s, are generally required to provide coverage for any covered outpatient drug that is medically necessary once the drug manufacturer enters into a rebate agreement and the medicine is approved by the FDA and prescribed by a provider. Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 652, 123 S. Ct. 1855 (2003) (“PHARMA”); 42 U.S.C. §§ 1396r-8(a)(1), 1396r-8(d)(B), 1396r-8(k)(2)(A); (6). WHCA covers DAAs, including Harvoni, under the Washington State Medicaid Plan, but only for the most severely ill individuals with HCV. WHCA refuses to cover the medication for Medicaid enrollees with less severe liver damage or other symptoms of HCV, even though the medications will likely cure them. 20. Covered Prescription Drugs, Including DAAs, Must Be Provided When Medically Necessary, with “Reasonable Promptness,” for All Comparable Medicaid Enrollees. Since Harvoni and other DAAs meet the standard for coverage under Washington’s Medicaid program, the Medicaid Act requires coverage of the medicine when it is medically indicated. 42 U.S.C. §§ 1396a(a)(10)(A); 1396r-8. See also WAC 182-500-0070 (defining “medical necessity” in Washington’s Medicaid program). Under COMPLAINT (CLASS ACTION) – 7 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 8 of 16 1 Washington’s Medicaid program, if the treatment is covered and medically necessary, it 2 must also be provided with “reasonable promptness,” typically within 90 days. 3 42 U.S.C. § 1396a(a)(8); Doe v. Chiles, 136 F.3d 709, 714 (11th Cir. 1988). In addition, 4 medically necessary prescription drug coverage, including access to Harvoni and other 5 DAAs, cannot be made available in a lesser amount, duration or scope than the coverage 6 made available to any other individual eligible under the State Medicaid Plan. 42 U.S.C. 7 § 1396a(a)(10)(B); 42 C.F.R. § 440.240. This is known as Medicaid’s “comparability” 8 requirement. See Jenkins v. Washington Department of Social and Health Services, 162 Wn. 9 2d 287, 296-97 (2007). WHCA’s coverage criteria for HCV treatment must comply with 10 all three of these Medicaid Act requirements. 11 12 WHCA’S UNIFORM EXCLUSIONARY COVERAGE CRITERIA 21. WHCA Has Adopted Coverage Criteria for Harvoni and Other DAAs. 13 WHCA has adopted a uniform coverage approach with respect to when and under what 14 conditions it will approve Harvoni and other similar DAAs for coverage under 15 Washington’s Medicaid program. A copy of WHCA’s Coverage Criteria is attached as 16 Appendix 1. 17 22. WHCA Does Not Provide Coverage for All Its HCV-infected Insureds. 18 WHCA’s coverage criteria generally exclude coverage for Harvoni and other DAAs for 19 Medicaid enrollees with fibrosis scores of F0, F1 and F2 where no other conditions are 20 present. 21 23. WHCA’s Coverage Criteria Are Inconsistent With Accepted Medical 22 Practice. WHCA has no clinical or medical basis to deny treatment to Medicaid 23 enrollees who have a fibrosis score of F0, F1 or F2. On the contrary, the HCV Guidelines 24 provide that “[b]ecause of the myriad benefits associated with successful HCV 25 treatment, clinicians should treat HCV-infected patients with antiviral therapy with the 26 goal of achieving an SVR, preferably early in the course of their chronic HCV infection COMPLAINT (CLASS ACTION) – 8 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 9 of 16 1 before the development of severe liver disease and other complications.” See 2 http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy 3 visited 1/25/16) (emphasis added). Treatment of HCV even in patients with mild or no 4 liver disease decreases complications and death rate due to liver disease and prevents 5 transmission of HCV to others. 6 24. (last WHCA’s Coverage Criteria Put Medicaid Enrollees at Risk of Multiple 7 HCV Complications, Including Death. WHCA’s Medicaid enrollees who meet the 8 standards set forth by the American Association for the Study of Liver Diseases and the 9 Infectious Diseases Society of America, but who are excluded under WHCA’s coverage 10 criteria, are put at risk. They are needlessly exposed to health conditions caused by 11 HCV, including cirrhosis, cancer, fatigue, joint pain, depression, sore muscles, arthritis, 12 avoidable liver transplants, jaundice and even death. In addition, the lack of treatment 13 of infected individuals increases the chance that members of the insured’s household 14 and the public will be exposed to and contract HCV. 15 25. WHCA Has Publicly Stated Its Coverage Position. WHCA’s coverage 16 position is publicly posted on WHCA’s website. 17 medicaid/pharmacy/Documents/hepatitis_c_treatment_policy.pdf 18 02/02/16). It is known by many doctors treating Medicaid enrollees. 19 26. See http://www.hca.wa.gov/ (last WHCA’s Coverage Criteria Impermissibly Ration Care. visited WHCA’s 20 coverage criteria are not tied to the requirements of the Medicaid Act, or to WHCA’s 21 regulations governing coverage of medically necessary prescription medications. 22 Rather, WHCA’s denial of coverage is an effort to ration care because of its concern over 23 the perceived expense of Harvoni and other DAAs. As stated by Donna L. Sullivan, 24 M.S., Pharm. D., HCA’s Chief Pharmacy Officer, the real reason that HCA continues to 25 employ the excessively restrictive coverage criteria is a political one: 26 COMPLAINT (CLASS ACTION) – 9 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 10 of 16 I’ve had discussions with Dr. Lessler, with Charissa and with the specialists in the community with the Department of Corrections as well as Labor and Industries, and I can guarantee you that all of us agree that everyone should be treated whether they are at stage 2, stage 3, stage 4. However, we have received funding only based on the criteria that we gave for F3. So we are having discussions with the Office of Financial Management with legislative staff. We have requested a supplemental budget to expand our coverage criteria to F3, but we can’t just open up our doors right now and do that. … It’s out of our hands. None of us would argue that we should not expand it, that it’s not the right thing to do, but we live in a political environment as a state that I have to operate within the resources and rules around those resources that have been given to us. 1 2 3 4 5 6 7 8 9 10 11 12 See http://www.hca.wa.gov/pdp/ptmeetingdocuments/Transcript_102115.pdf, p. 64 (emphasis added). These concerns cannot usurp WHCA’s obligations under the Medicaid Act. 13 PLAINTIFFS E. AND R. REQUIRE HARVONI TO TREAT HCV. 14 15 16 17 18 19 20 21 22 23 24 25 26 27. Plaintiffs Are Enrolled in Medicaid. During certain time periods on and after October 10, 2014, Plaintiffs E. and R. have been, are or will be enrolled in Washington state’s Medicaid program, which is administered by WHCA. Both are “qualified individuals” as defined in 42 U.S.C. § 1396a(a)(10)(A). 28. Treatment With Harvoni Is Recommended and Prescribed for Both Plaintiffs. Plaintiffs E. and R. both are diagnosed with HCV. Plaintiffs both have a Metavir Fibrosis Score of F0. Both plaintiffs had Harvoni prescribed by their treating medical providers. 29. Treatment With Harvoni Is “Medically Necessary” for Plaintiffs B.E., R.A. and Similarly Situated Others Under the WHCA Definition of Medical Necessity. Treatment with Harvoni is “medically necessary” for plaintiffs and similarly situated others under the established definition of “medically necessary” located in WAC 182-500-0070, and established by the consent order in Mead v. Burdman, No. 818663 COMPLAINT (CLASS ACTION) – 10 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 11 of 16 1 (King Cty. Sup. Ct., J. Hunter, March 20, 1978). Harvoni and other similar DAAs are 2 likely to cure plaintiffs E., R. and other similarly situated individuals. There is no equally 3 effective, less costly alternative prescription drug or medical intervention, and WHCA 4 has offered none. WHCA apparently takes the position that treatment may be delayed 5 because the adverse health effects of chronic HCV can be reversed until a Metavir 6 Fibrosis Score of F3 or F4 is reached. This position is inconsistent with clinical studies of 7 HCV treatments, the AASLD/ISDA Treatment Recommendations and the standard of 8 care for treatment of HCV in Washington state. 9 30. Plaintiffs’ Request for Coverage of Harvoni Was Denied Under WHCA’s 10 Uniform Coverage Criteria. WHCA denied Ms. E.’s preauthorization request for 11 treatment with Harvoni on January 12, 2016 because her Metavir Fibrosis Score was 12 under F3 and she had no qualifying co-morbid condition. WHCA did not offer Ms. E. 13 any other medication as an alternative to treat her HCV. WHCA denied Mr. R.’s 14 pre-authorization request for treatment with Harvoni on June 15, 2015 because his 15 Metavir Fibrosis Score was under F3 without a qualifying co-morbid condition. WHCA 16 did not offer Mr. R. any other medication as an alternative to treat his HCV. Neither 17 plaintiff was provided with notice of the denial that met constitutional due process 18 requirements. Nonetheless, Mr. R. appealed. An administrative hearing was held on 19 September 30, 2015. Mr. R. appeared pro se, and the Administrative Law Judge issued 20 an initial decision, upholding WHCA’s denial. Mr. R. appealed the decision to the 21 WHCA Board of Appeals, which, sua sponte, remanded the case to the Administrative 22 Law Judge for an additional hearing. 23 24 25 26 COMPLAINT (CLASS ACTION) – 11 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 12 of 16 VI. CLASS ALLEGATIONS 1 2 31. (a) 3 5 7 8 9 10 11 (iii) do not meet the coverage criteria for HCV medication adopted by WHCA, as set forth in Appendix 1. 12 13 16 17 18 19 20 21 22 23 24 were, are, or will be enrolled in Washington state Health Care Authority’s Medicaid Program on or after October 10, 2014; (ii) require, or are expected to require treatment for Hepatitis C with Harvoni/ledipasvir-sofosbuvir or other similar direct acting antivirals under the current guidelines adopted by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (see http://www.hcvguidelines.org/full-report/whenand-whom-initiate-hcv-therapy) (last visited 1/25/16); and 6 15 all individuals who: (i) 4 14 Size and Definition of Class. The class consists of: 32. Class Representatives B.E. and A.R. As noted above, named plaintiffs B. E. and A. R. are enrolled in WHCA’s Medicaid Program. Both have HCV and require treatment with Harvoni. Both have been denied coverage of Harvoni because their Metavir Fibrosis Score is under F3 and they have no qualifying co-morbid condition. Both plaintiffs meet the criteria for treatment under the guidelines approved by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Their claims are typical of the claims of the other members of the class, and they will fairly and adequately represent the interests of the class. Neither have any conflicts of interest with the class. 33. Size of Class. The class is sufficiently numerous. WHCA has denied coverage of Harvoni and other DAAs to at least 900 Medicaid consumers since January 1, 25 26 COMPLAINT (CLASS ACTION) – 12 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 13 of 16 1 2015, likely because the enrollees had a Fibrosis Score of F0, F1 or F2.1 WHCA estimates 2 that if it expanded its coverage to include all enrollees with Fibrosis Score of F2, an 3 additional 4700 Medicaid enrollees would be affected.2 As a result, the class numbers in 4 the thousands and is so large that joinder of all members is impracticable. 34. 5 Common Questions of Law and Fact. This action requires a determination 6 of whether WHCA’s coverage criteria that denies, excludes and/or limits coverage of 7 Harvoni and other similar DAAs violates the Medicaid Act. A determination of this 8 issue will in turn determine whether plaintiffs and the class are entitled to declaratory 9 and injunctive relief. 35. 10 WHCA Has Acted on Grounds Generally Applicable to the Class. WHCA, 11 by applying a uniform policy that results in the exclusion of Harvoni and other similar 12 DAAs to plaintiffs and others similarly situated, has acted on grounds generally 13 applicable to the class. Certification is therefore proper under Fed. R. Civ. P. 23(b)(2). 36. 14 15 Class Counsel. Plaintiff has retained experienced and competent class counsel capable of representing the class expertly and without conflict of interest. 16 VII. CLAIMS FOR RELIEF 17 FIRST CLAIM: EXCLUSION OF QUALIFIED INDIVIDUALS FROM COVERED MEDICAL ASSISTANCE UNDER THE MEDICAID ACT 18 19 20 21 22 23 37. Plaintiff re-alleges all of the above paragraphs. 38. Plaintiffs and the class are entitled to declaratory and injunctive relief pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 that defendant has violated Title XIX of the Social Security Act (also known as the Medicaid Act) by excluding qualified Medicaid recipients from medically necessary treatment as required by 24 25 26 1 See http://www.hca.wa.gov/pdp/ptmeetingdocuments/Hep_C_DUR_1015.pdf, p. 3 (WHCA received 1695 requests for HCV treatment from January-June 2015, and only approved 45% of the requests, denying more than 900 Medicaid enrollees curative treatment). 2 http://www.hca.wa.gov/Documents/budget/2016_PL-2_Hepatitis_C_Treatment_Expansion.pdf. SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 COMPLAINT (CLASS ACTION) – 13 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 14 of 16 1 42 U.S.C. §1396a(a)(10)(A). 2 SECOND CLAIM: VIOLATIONS OF MEDICAID COMPARABILITY 3 39. Plaintiff re-alleges all of the above paragraphs. 4 40. Plaintiffs and the class are entitled to declaratory and injunctive relief 5 pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 because defendant, by 6 discriminating among similarly situated Medicaid recipients on the basis of categorical 7 restrictions that are not based upon prevailing clinical standards, has violated Medicaid 8 Act comparability requirements, 42 U.S.C. § 1396a(a)(10)(B)(i) and (ii); 42 C.F.R. 9 § 440.240. 10 THIRD CLAIM: VIOLATIONS OF REASONABLE PROMPTNESS 11 41. Plaintiff re-alleges all of the above paragraphs. 12 42. Plaintiffs and the class are entitled to declaratory and injunctive relief 13 pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 that defendant has violated 14 the “reasonable promptness” requirement of Title XIX of the Social Security Act, 42 15 U.S.C. § 1396a(a)(8), by implementing a policy that de facto rations coverage for Medicaid 16 enrollees seeking HCV treatment, thereby requiring plaintiffs and the class to wait until 17 they have developed severe liver damage before receiving medically necessary 18 treatment. 19 VIII. DEMAND FOR RELIEF 20 WHEREFORE, plaintiffs request that this Court: 21 (a) Certify this case as a class action, designate the named plaintiffs as class 22 representatives, and designate SIRIANNI YOUTZ SPOONEMORE HAMBURGER, Richard E. 23 Spoonemore and Eleanor Hamburger, COLUMBIA LEGAL SERVICES, Amy L. Crewdson, 24 and CENTER FOR HEALTH LAW AND POLICY INNOVATION, Kevin Costello, as class counsel; 25 26 (b) Declare that WHCA may not apply policies or practices that exclude or impermissibly limit treatment of HCV with Harvoni or other similar DAAs pursuant to COMPLAINT (CLASS ACTION) – 14 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 15 of 16 1 coverage criteria that are inconsistent with the current AASLD/IDSA Treatment 2 Guidelines; 3 4 5 (c) Enjoin WHCA from continuing to implement and apply its current HCV Treatment Policy, attached as Appendix 1; (d) Require WHCA to provide corrective and constitutionally adequate notice 6 to class members, and to reprocess and approve coverage for all class members who 7 were previously denied coverage under WHCA’s current HCV Treatment Policy; 8 9 (e) Award plaintiffs and the class their attorney fees and costs pursuant to 42 U.S.C. § 1988; and 10 (f) Award such other relief as is just and proper. 11 DATED: February 16, 2016. 12 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 13 By: s/ Richard E. Spoonemore By: s/ Eleanor Hamburger Richard E. Spoonemore (WSBA #21833) Eleanor Hamburger (WSBA #26478) 14 15 16 999 Third Avenue, Suite 3650 Seattle, WA 98104 Tel. (206) 223-0303 Email: rspoonemore@sylaw.com ehamburger@sylaw.com 17 18 19 20 COLUMBIA LEGAL SERVICES 21 By: s/ Amy L. Crewdson Amy L. Crewdson (WSBA #9468) 22 711 Capitol Way South, #304 Olympia, WA 98501 Tel. (360) 943-6585, Ext. 214 Email: amy.crewdson@columbialegal.org 23 24 25 26 COMPLAINT (CLASS ACTION) – 15 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246 Case 2:16-cv-00227 Document 1 Filed 02/16/16 Page 16 of 16 HARVARD LAW SCHOOL CENTER FOR HEALTH LAW & POLICY INNOVATION 1 2 By: s/ Kevin Costello Kevin Costello (pro hac vice admission to be sought) 3 122 Boylston Street Jamaica Plain, MA 02130 Tel. (617) 390-2578 Email: kcostello@law.harvard.edu 4 5 6 Attorneys for Plaintiffs 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 COMPLAINT (CLASS ACTION) – 16 SIRIANNI YOUTZ SPOONEMORE HAMBURGER 999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246