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New California HCV Treatment Restrictions.....requires urine-analysis/denies access to drug users unless abstinent for 6 months/requires advanced disease to be treated
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These California restrictions are the latest in a shamefully brutal attempt to deny access to life-saving new HCV treatments as some medicaid's say drug users & patients with early disease cannot get treated. California officials rejected pleas from HCV expert doctors not to use these harsh restrictions:
http://www.natap.org/2014/HCV/081914_01.htm. In the US $10 billion is spent annually on HIV care & treatment ($5 bill by Medicaid & $5 bill by medicare) so why is HCV so different to these medicaids its actually much less expensive to treat & cure HCV. HCV is curable, the 1st virus that can be cured, with 12 weeks therapy without interferon. HIV care & treatment is for a lifetime, over the course of time HIV treatment is $380,000 for a patient & $1 million for care. It is MORE expensive not to treat & cure HCV (http://www.natap.org/2014/HCV/021914_02.htm) (http://www.natap.org/2014/HCV/062514_03.htm). Even United Healthcare says its cost-effective: http://www.natap.org/2014/HCV/062514_07.htm. It is time for the federal govt to step in & design a new model for paying for new innovative life-saving medical treatments: http://www.natap.org/2014/HCV/080614_02.htm. Some observers think medicaid's are drawing a line in the sand here with HCV to set the climate for coming new innovative life-saving treatment for serious diseases like cancers. This is unacceptable & un-American. This flies in the face of the ACA whose underlying principle is to provide care & treatment to sick people & not to deny access.
Lawsuits appear to be coming, in fact Matt Salo, director of a national medicaid organization suggested the courts may overturn these restrictions: http://www.natap.org/2014/HCV/082214_03.htm http://www.natap.org/2014/HCV/081814_02.htm
these restrictive practices may be illegal & Medicaids are misleading the public with deceptive PR campaign intended to scare the public: medicaid's receive 23% discount on HCV drugs, VA 44%, so its not 84k Sovaldi its 60-65k; only 70,000 patients this year have been treated with Sovaldi in the entire nation so their projected cost claims appear over-inflated & were only projections intended to scare the public. These restrictive practices may be illegal, according to the Medicaid Rebate Law it appears to say in return for a discount Medicaid provides treatment & there is no suggestion that restrictions to access are permitted:
Section 1927 of the Social Security Act (actual text of the law establishing the Medicaid drug rebate program):
http://www.ssa.gov/OP_Home/ssact/title19/1927.htm
New California Restrictive HCV Policy - "patients with mild liver disease.....not eligible....all patients should be evaluated for current alcohol & other substance abuse....must have urine toxicology screen....patients with substance use disorder must be abstinent or actively participating in treatment for disorder for 6 months prior to HCV treatment"
Illinois Medicaid recently implemented a similar program.......Interview with Ill Medicaid Medical Directors where he comments: http://www.natap.org/2014/HCV/080814_07.htm
Download the PDF here
New California HCV Treatment Policy Requires Urine Analysis for Substance Use; Denies Access to Drug Users(IDUs) & Patients with Early HCV Disease: patients must have documented advanced HCV disease
California Department of Health Care Services
Utilization and Treatment Policy for Simeprevir and Sofosbuvir
in the Management of Hepatitis C
http://www.dhcs.ca.gov/Documents/Hep_C_Policy.pdf
Download the PDF here
Excerpts:
"For genotypes 1,2, and 3, patients with mild liver disease (equivalent to METAVIR F0-2), except for those with serious extra-hepatic manifestations or post-liver transplant (see Section 5), are not eligible for sofosbuvir- or simeprevir-based regimens."
"For consideration of treatment with sofosbuvir and/or simeprevir as part of a Hepatitis C treatment regimen, all patients must have a documented METAVIR score of F3 (advanced fibrosis) or F4 (cirrhosis) on liver biopsy OR strong clinical suspicion for advanced fibrosis/compensated cirrhosis"
Substance Use
"All patients should be evaluated for current alcohol and other substance abuse, with validated screening instruments such as AUDIT or AUDIT C. All patients considered for treatment with simeprevir or sofosbuvir must have urine toxicology screen at baseline."
"The presence of current heavy alcohol use (>14 drinks per week for men or >7 drinks per week for women), binge alcohol use (>4 drinks per occasion at least once a month), and/or active injection drug use and/or other illicit drug use as documented with a positive urine toxicology screen requires referral to treatment of substance use disorder (preferably to an addiction treatment specialist) before HCV treatment initiation. Patients with a substance abuse disorder must be actively participating in treatment for the disorder or be abstinent for 6 months prior to the initiation of HCV treatment."
Earlier HCV Treatment Reduces Serious Liver Disease Outcomes - (08/12/14)
Medicaids/ Feds Deny HCV Treatment to Poor/Disenfranchised, Those Most Affected by HCV- - (08/19/14)
Medicaid Restrictions, Opoid Replacement Therapy, African-Americans, Depression/Comorbidities....is this legal? A lawsuit- "swift overturn in courts" - (08/18/14)
Medicaids Restrictions Based on Misleading Information: African-Americans/ Opoid Replacement (Methadone) Users SVR Rates, comorbidities - (08/18/14)
HCV Guidelines Questionably Prioritize The Sickest To Be Treated, New Guidelines Section- "WHEN AND IN WHOM TO INITIATE HCV THERAPY" - commentary - (08/12/14)
HCV Treatment, HIV Treatment: public & personal health denied - HCV Cost Burden - commentary - (08/11/14)
Interview with Illinois Medicaid Medical Director Re: their new restrictions on Sovaldi Access - (08/08/14)
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