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HCV Treatment Access Restrictions - HCV Can Be Eradicated !
  from Jules: following 2 months of me generating my commentaries that criticized some medicaids, not all, that are implementing severe harsh restrictions to patient access to treatment, 3 organizations/coalitions released announcements of objections to restrictions. The announcement by the 2 HIV/ID Doctor Groups did not go far enough only mentioning restriction that only hepatitis doctors can treat HCV, and the announcement by the advocacy group NVHR did touch on all the restrictions, see these announcements below following this link to all my commentaries over the past 6-8 weeks. As well, a publication by Brian Edlin (see below) offers similar criticisms. Ongoing in NYC yesterday & today Sept 12/13 is the AASLD/EASL Special HCV Conference where many discussions have included these restrictions. Today at the open microphone 3 individuals spoke out including myself. One person said the lawyers will start to sue these medicaid's and in fact that appears to be in the works & the director of a national medicaid association actually said if sued I think we would lose.....http://natap.org/2014/HCV/081814_02.htm. The HCV Guidelines committee included in their recent update a controversial recommendation that patients with F3/F4 should be prioritized for treatment, but they say they did this because of the payer/medicaid restrictions, that with these payer restrictions & thus limited access at least through medicaid underscore that we should prioritize these most sick with advanced disease patients, however they hope that over the near term these restrictions will go away because as doctors they would treat any patient who walks in their door who wants to be treated, with early or late disease, so I think they should issue a separate announcement saying this, that these restrictions are too onerous & harsh, that all patients should have access to be treated, its a decision between doctor & patient regardless of disease stage.
Medicaid HCV Treatment Restrictions Denying Care & Treatment, which HCV Guidelines Committee Supported - (09/11/14)
restrictions say: ......we will only treat patients with advanced HCV disease (F3/F4).......will not treat drug users.......California requires a urinalysis.......only hepatitis experts can treat the disease........medicaid gets a minimum 24% discount/rebate which is negotiable, that reduces price to perhaps $63,000 or less, the VA gets a 44% discount/rebate, commercial payers behind the scenes negotiate for discounts and receive them. The Social Security Medicaid Rebate Law says in return for a 23% rebate state medicaid is to provide treatment, there is no mention of permissible restrictions.....http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Medicaid-Drug-Rebate-Program.html......the costs these medicaids claimed were hyper inflated, they were projections, they discussed the millions of patients who would be treated & their projected costs were based on those projections, they over-inflated their costs, but Only 70,000 this year......this year have been treated with Sovaldi nationwide, when telaprevir & boceprevir were approved only 100,000 were treated in the first year, our healthcare system is such that patients are not all treated at once, it takes time to process through the system........Healthcare should not be based on the one-year budget system ......Commercial payers are required to provide access to treatment.....its time for a new model for healthcare evaluation.......New Models for Healthcare Funding Needed ........ In fact United HealthCare says HCV treatment is cost effective http://www.natap.org/2014/HCV/062514_07.htm.
ALTHOUGH, these HIV medical/doctor groups released this press release with a criticism of a medicaid objection, the medicaid restriction that only hepatitis expert doctors could provide treatment, the press release did NOT say a word about the other medicaid restrictions, which are in some ways more onerous to patients, that drug users can t be treated unless & until they enter a drug treatment rehab, that only patients with advanced disease could be treated (F3/F4). Still, their complaint is very valid: resifting HIV doctors from treating HIV/HCV coinfected patients is outrageous and another of the 4 horrible restrictions put on patients by some of the medicaids.
HIV Medical Associations Challenge Insurer Restrictions to HCV Treatment - IDSA/ HIVMA/AAHIVM - (09/03/14)
Community Leaders Call For End To Hepatitis C Treatment Access Crisis
Community Leaders Call For End To Hepatitis C Treatment Access Crisis

Urge HHS Secretary Burwell to ensure lifesaving treatment is available for everyone living with the chronic, infectious, life-threatening disease.
FOR IMMEDIATE RELEASE | September 10, 2014
A coalition of leading hepatitis C advocacy organizations and medical experts today called on Health and Human Services Secretary Sylvia Mathews Burwell to take leadership in eliminating harmful and discriminatory barriers to hepatitis C treatment access. The coalition sent a letter expressing alarm over restrictions placed by many public and private payers on access to new effective hepatitis C treatments that have high cure rates and minimal side effects. The coalition also sent a statement signed by over 700 organizations, individuals, and medical providers demanding availability of treatment for everyone living with hepatitis C and calling on all stakeholders, including government, the pharmaceutical industry, and public and private payers to work together on solutions.
"The recent FDA approval of highly effective new treatments brought tremendous hope to the millions of Americans estimated to have chronic hepatitis C," said Ryan Clary, Executive Director of the National Viral Hepatitis Roundtable (NVHR). "However, that hope quickly diminished when public and private payers, including many state Medicaid programs, implemented restrictions that provide access only to the sickest patients and deny access to those with active or recent substance use issues. These barriers undermine the purpose of the Affordable Care Act both to provide quality affordable health care to people regardless of pre-existing conditions and also to eliminate health disparities." Advocates are particularly alarmed by restricted treatment access in many state Medicaids, the safety net health program for low-income Americans. The Center for Health Law and Policy Innovation at Harvard Law School is currently researching state Medicaid polices with respect to accessing these new treatments. Looking specifically at fee for service programs, preliminary analysis indicates that many states are now limiting treatment to individuals with severe liver damage (those with a metavir score of F3 or F4) and are also requiring significant periods of sobriety, usually between 3-6 months, in order to be treatment eligible.
These restrictions contradict recommendations in a recent article published in Antiviral Research by Dr. Brian Edlin and colleague Emily Winkelstein of Weill Cornell Medical College and the National Development and Research Institutes, in which they make the case for achieving hepatitis C eradication in the United States– an achievable goal, but one facing serious challenges. Care and treatment is a critical piece of the six-part strategy outlined by Dr. Edlin, which stresses the need to also enhance and scale up surveillance and epidemiology, prevention, testing, social policy, and research. Such a comprehensive plan can only be realized with solid political will, adequate investment, and robust advocacy.
(in Brian Edlin's publication http://www.sciencedirect.com/science/article/pii/S0166354214002149-
Download the PDF here
"Can hepatitis C be eradicated in the United States?"....he says ....." ......Provide universal access to hepatitis C prevention and treatment services to all persons living in the United States.......Eliminating hepatitis C from the United States is possible, but will require a sustained national commitment to reach, test, treat, cure, and prevent every case. With strong political leadership, societal commitment, and community support, hepatitis C can be eradicated in the United States. If this is to happen in our lifetimes, the time for action is now........Sufficient funding for all of this needs...........All adults should be screened for hepatitis C, but special efforts must focus on groups with increased prevalence through community outreach and rapid testing......Provide testing in community settings, homeless services, correctional facilities, and other criminal justice settings in addition to health facilities......Provide hepatitis C testing wherever HIV testing is available......Government, industry, and payers must work together to assure full access to health services and antiviral drugs for everyone who is infected......Healthcare providers and systems, especially primary care practitioners, need education and training in treating hepatitis C and caring for substance-using populations......Services must be provided to the disadvantaged and stigmatized members of society who bear a disproportionate burden of the epidemic .......Environments must be created where people who use drugs can receive prevention and treatment services without shame or stigma.....Use strategies proven effective for HIV testing such as low-threshold testing and financial incentives in marginalized high-risk populations......Build public health infrastructure where PWID can receive multidisciplinary health services (including prevention and care) without fear of shame or stigma.......Public health agencies must work with penal institutions to provide prevention and treatment services, including antiviral therapy, to those in need in jails and prisons or on probation or parole......Strong and sustained political advocacy will be needed to build and sustain support for these measures. Leadership must be provided by physicians, scientists, and the public health community in partnership with community advocates and people living with or at risk for hepatitis C.......Create a national action plan incorporating public health, public safety, academic, healthcare, industry, and community stakeholders, and sufficient resources, to prevent and treat hepatitis C.....Sustained political advocacy to motivate the above [John Ward says about 50% of those infected with HCV were infected by injection drug use, here in NYC yesterday at a AASLD/EASL HCV workshop he said CDC official numbers say about 3.2 mill have HCV in the USA, 1.5 mill are IDUs].......
"At this watershed moment in the epidemic, just at the moment that we have the tools to eradicate this scourge, it would be a perverse and shameful indictment of our healthcare system if the structure of medication financing in our country were to foil our ability to use them, said Dr. Edlin. "Affordable pricing will assure the largest possible market for the drugs, a win-win arrangement. Government, industry, and payers must work together to reach agreements to assure full access to antiviral drugs for all who need them."
Advocates will continue to call on all stakeholders to develop collaborative solutions to end the hepatitis C treatment access crisis. "Everyone living with hepatitis C deserves lifesaving treatment," said Emalie Huriaux, Director of Federal and State Affairs at Project Inform. "Treatment decisions should be made by people with hepatitis C and their doctors, not by insurance companies. The only way we will end the hepatitis C epidemic in the United States is by assuring access to the cure to everyone."
IDSA, HIVMA Call for State Medicaid Programs to Lift Hepatitis C Prescribing Restrictions from ID and HIV Doctors
Statement from IDSA President Barbara Murray, MD, FIDSA, and HIVMA Chair Joel Gallant, MD, MPH, FIDSA
At a time when curative treatment is available for hepatitis C (HCV), some state Medicaid programs are instituting harmful barriers to the new HCV treatment, including limiting the availability of physicians to treat this growing epidemic by restricting infectious diseases and HIV physicians from prescribing life-saving medications. An estimated 4 million people in the U.S. are infected with HCV and at least 20,000 new infections occur every year.
The Infectious Diseases Society of America (IDSA) and HIV Medicine Association (HIVMA) urge the Centers for Medicare and Medicaid Services (CMS) to carefully review all state restrictions on the new HCV treatment to ensure they are evidenced-based and to bar states from excluding ID and HIV physicians from prescribing the new HCV treatments.
"ID and HIV specialists are on the front lines of hepatitis C research and treatment. Our background in understanding this disease and the therapies approved to treat it give us a level of expertise that may not be available via other medical specialties," said Barbara Murray, MD, President of IDSA. "It is estimated that half of patients infected with hepatitis C are unaware of their status. As increased emphasis on testing and diagnosis is realized, we may be faced with a shortage of physicians available to treat and care for these patients. Now is not the time to place restrictions on the availability of physicians, especially those with some of the most experience treating this disease."
"As many as 25 percent of hepatitis C patients are co-infected with HIV. As an ID and HIV specialist, I am intimately familiar with the mechanisms of action of these advanced therapies, which are similar to those used to treat HIV," said Joel Gallant, MD, Chair of HIVMA. "Due to their understanding of these therapies, my non-ID trained colleagues who are HIV specialists are also well suited to treat co-infected patients and to handle complications that may arise from therapy. Restricting us from providing this care does a great disservice to our patients and to public health."
Recognizing the importance of expanding clinical expertise on hepatitis C, IDSA and the American Association for the Study of Liver Diseases (AASLD), in collaboration with IAS-USA, have led the way in providing timely clinical guidance for the therapy of hepatitis C via www.hcvguidelines.org. This website is a living document that provides timely updates to assist prescribers on treating this patient population. The guidance finds that all individuals with chronic HCV will benefit from treatment, but offers recommendations for prioritization when necessary.
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