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Lawsuit Successful in Washington State to Remove HCV Restrictions: federal district court Judge Orders State Medicaid to Cover HCV Drugs
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Download the PDF here
Download the PDF here
....[Press Release below following these excerpts I took out of the Order document pdf attached, press release pdf is attached too]
"In conclusion, the Court finds that the Plaintiffs have satisfied all factors necessary to warrant granting a preliminary injunction. The WHCA is hereby ENJOINED from continuing to apply its February 25, 2015 HCV treatment policy, including its exclusion of all treatment based on fibrosis score, and is required to return to providing coverage for prescription medications to treat Hepatitis C virus ("HCV") without regard to fibrosis score, consistent with existing state and federal Medicaid requirements. "
from Jules: I have said for a long time that only a lawsuit or threat of a lawsuit will persuade state Medicaid officials to remove all restrictions. In NYS the Attorney General threatened lawsuit against commercial insurers and 7 commercial insurers were pursuaded to lift restrictions. Medicaid Managed Care (MCOs) in NYS still have restrictions and across the country in most Medicaid programs restrictions to HCV therapies persist.
As soon as the AASLD HCV Guidelines came out a few years ago I told the panel their language that in affect supported restrictions would be used by the Medicaid programs and it was; initially the Panel members all of whom knew me absolutely rejected what I said, refused to budge and pretty much excluded me from their "club". The Guidelines panel over time issued a number of different versions of their Guidelines with each one incrementally adjusting & tweaking the language but still used language supporting the restrictions, until finally last year issuing a new version of the Guidelines stating that 'all patients should be treated', that access to treatment should be unfettered, read below, now state officials can no longer use the language and apparently the new language is used to support the lawsuit:
In the attached Order document [excerpts]: "the use of DAAs such as Harvoni is considered the "standard of care" by the American Association for the Study of Liver Disease ("AASLD") and the Infectious Diseases Society of America ("IDSA")"
"The appropriate legal test is whether Plaintiffs will likely establish that the current WHCA Hepatitis C Treatment Policy deprives Medicaid enrollees from access to a life-saving drug in situations where it is "medically necessary."
"....the Medicaid program must adhere to the Medicaid Act's specific limits regarding prescription drugs. (Id.) (Citing RCW §§ 74.04.055; 74.08.090); see also 42 U.S.C. § 1396a(a)(54). Under § 1396a(a)(10)(A), the Medicaid Act "prohibits states from denying coverage of 'medically necessary' services that fall under a category covered in their Medicaid plans." Alvarez v. Betlach, 572 F. App'x 519, 521 (9th Cir. 2014) (quoting Beal v. Doe, 432 U.S. 438, 444 (1977)). "
"Plaintiffs have provided strong evidence that DAAs are, in fact, "medically necessary," as defined by law, for all enrollees with HCV, regardless of fibrosis score. They submitted a plethora of exhibits showing that providing DAAs to all HCV-infected enrollees is the standard espoused by national liver disease organizations and experts, leading medical officers of major Washington providers and the federal agency responsible for administering Medicaid. These facts "clearly favor" Plaintiffs' claim that the WHCA's Policy excluding monoinfected enrollees with a Fibrosis score of F0-F2 violates Federal law. Stanley at 1319-20. "
"WHCA participates in Medicaid, receiving federal matching funds, and therefore is required to provide payment for FDA-approved, covered prescription drugs to all Medicaid enrollees when the treatment is "medically necessary." Alvarez v. Betlach, 572 F. App'x 519, 520-21 (9th Cir. 2014); see also Armstrong v. Exceptional Child Ctr., Inc., 135 S. Ct. 1378, 1382 (2015) ("Medicaid offers the States a bargain: Congress provides federal funds in exchange for the State's agreement to spend them in accordance with congressionally imposed conditions.").
"...the Medicaid Act requires the WHCA to provide that treatment with "reasonable promptness" in a non-discriminatory manner"
"It is well-established that denying necessary Medicaid services causes irreparable harm. Rodde v. Bonta, 357 F.3d 988, 999 (9th Cir. 2004) (finding that while the injunction would cause the county financial hardship, the plaintiffs met their burden by showing delayed or lack of necessary treatment, increased pain, and medical complications); Beltran v. Myers, 677 F.2d 1317, 1322 (holding that plaintiffs' showing of risk of irreparable injury as a result of denying needed medical care was sufficient to meet this factor for a preliminary injunction)."
WHY THE EARLIEST POSSIBLE HCV TREATMENT IS NECESSARY:
"An experience endured by a Medicaid enrollee provides a clear example of the substantial risk of deteriorating health and death presented by the Policy. L.B., a Washington Medicaid enrollee, was prescribed Solvaldi, a DAA, in July 2014. (Dkt. No. 23 at 1-2.) His request was denied. (Id. at 2.) The WHCA's letter on August 21, 2014 states that because L.B. did not have a fibrosis score of "F3 or greater," the treatment was not "medically necessary." (Dkt. No. 23-1 at 5.) Soon after, in October 2014, Harvoni was approved by the FDA and L.B.'s provider submitted his prescription to WHCA. (Dkt. No. 23 at 2.) His provider noted that his "cirrhosis and renal function [were] worsening. [He n]eeds HCV treatment ASAP" and that [w]ithout it, [he will] likely die." (Id.) Again, his request was denied.1 (Id). While he awaited a hearing on his Medicaid administrative appeal, "his kidneys deteriorated so significantly that his provider could no longer recommend Harvoni." (Id. at 2-3.) In other words, the window of L.B.'s ability to seek a cure for his HCV has likely closed. This is not speculative harm. It is concrete evidence that under the Policy, an enrollee suffered such severe liver damage that DAA treatment may no longer be an available option. "
"The Ninth Circuit holds that "the balance of hardship favors beneficiaries of public assistance who may be forced to do without needed medical services over a state concerned with conserving scarce resources." M.R. v. Dreyfus, 697 F.3d 706, 737-38 (9th Cir. 2012). The Ninth Circuit also noted the strong public interest in protecting access to health care for Medicaid enrollees, those deemed by Congress as "the most needy in the country." Id. (quoting Schweiker v. Hogan, 457 U.S. 569, 590 (1982)). "........"The Court agrees. "[H]aving government officials act in accordance with law . . . invokes a public interest of the highest order." Seattle Audubon Soc. v. Evans, 771 F. Supp. 1081, 1096 (W.D. Wash. 1991). Furthermore, as Plaintiffs emphasize, an injunction is an important matter for the public because it deals with the treatment and management of a communicable disease. (Dkt. No. 18 at 27.) "
"The WHCA argues that the injunction would double the State's Medicaid outpatient Pharmacy budget and cause them to reduce Medicaid enrollments, benefits, or provider rates to compensate for the increased expenditure in HCV treatment. (Dkt. No. 29 at 22.) The Ninth Circuit has also addressed the question of balancing the risk of irreparable harm with the risk of financial hardship for the enjoined institution. Posed with this question, the Ninth Circuit held that when "[f]aced with such a conflict between financial concerns and human suffering, we have little difficulty concluding that the balance of hardships tips decidedly in plaintiffs' favor." Lopez v. Heckler, 713 F.2d 1432, 1437 (9th Cir. 1983). "
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LAWSUIT CHALLENGE SUCCESSFUL - WASHINGTON STATE MEDICAID MUST NOW OFFER TREATMENT TO HEPATITIS C PATIENTS
Federal Court Orders Washington State Medicaid to Cover HCV Curative Treatment
SEATTLE, Wash. - May 27, 2016 - Today federal district court Judge John C. Coughenour handed patients diagnosed with Hepatitis C virus (HCV) an unmitigated victory, ordering the state Medicaid agency, the Washington Health Care Authority, to cover treatment for curative therapy for Hepatitis C. A copy of the Order is attached.
The patients had sued the Washington State Health Care Authority to get treatment with new HCV medications that cure more than 90% of patients. But the Health Care Authority limited access to the cure to only patients whose liver had been seriously damaged by the disease, even though scientific evidence shows that earlier treatment results in higher cure rates and better long-term health results. The plaintiffs' attorneys argued that forcing Medicaid enrollees to wait until their health worsens violates the federal Medicaid Act, which promises that low-income patients on the program may have access to medically necessary treatment. Well-established clinical guidelines of the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommend treatment for nearly all patients: "[C]linicians should treat HCV-infected patients with antiviral therapy with the goal of achieving an SVR [sustained virologic response or cure], 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 (emphasis added).
Judge Coughenour ordered that the Health Care Authority immediately stop applying its rationing policy and return to providing coverage for prescription medications to treat HCV without regard to the extent of a patient's liver damage.
HCV is an infectious disease that causes chronic inflammation throughout the body of those infected and can lead to serious liver damage, infections, liver cancer and death. At least 20,000people in the United States die each year due to causes related to HCV. Even before the advancedstate of the disease, individuals with HCV can suffer from diabetes, lymphoma, fatigue, joint pain, depression and arthritis.
With this ruling, Washington State Medicaid joins a growing list of national health insurers who have removed such restrictions on coverage of HCV medications. For example, Premera Blue Cross, Aetna, Cigna, United Healthcare and Blue Shield of California all recently removed restrictions related to severity of liver disease, having recognized that such limitations on coverage are not supported by clinical evidence.
"The clinical evidence is crystal clear," said Michael Ninburg, Executive Director of the Hepatitis Education Project in Seattle, Washington. "New curative therapies for HCV are medically necessary. Patients should not have to wait to get sick, sometimes irreversibly, before they can receive treatment."
"This Order will save lives," said Rick Spoonemore of Sirianni Youtz Spoonemore Hamburger, one of the plaintiffs' counsel in the case. "The State's exclusionary policy was put in place for one reason only - to save money. But saving money should never come at the expense of the health and lives of any patient, even if they are low-income and on Medicaid."
This is likely to be the first of many such lawsuits against state Medicaids around the country. "Medicaid programs should consider Judge Coughenour's Order and change their practices before they also get sued," said Kevin Costello of the Center for Health Law and Policy Innovations at Harvard Law School. "Rationing policies like the one used by the Washington Health Care Authority are in place in dozens of states across the country. All of those policies are likely improper as well."
END
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