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HIV Medical Associations Challenge Insurer Restrictions to HCV Treatment
  Below this press release is the letter sent to CMS-Medicare/Medicaid-
For Immediate Release
HIV Medical Organizations Challenge Insurer Restrictions to HCV Treatment

WASHINGTON, DC - The American Academy of HIV Medicine (AAHIVM) and the HIV Medicine Association (HIVMA), the two largest professional associations representing HIV clinicians in the U.S., are challenging new health plan cost control policies barring many qualified HIV care providers from prescribing certain medications that treat hepatitis C (HCV).
Of the 1.1 million Americans living with HIV, approximately 30 percent are co-infected with HCV. Many of these patients are currently being successfully cared for by an HIV practitioner. Yet some insurers are now enforcing policies to limit or remove HIV care providers' ability to prescribe new HCV medications.
These restrictive insurance policies exclude HIV providers who are not trained as gastroenterologists, hepatologists, or infectious diseases specialists from prescribing some medicines to treat HCV, and create other barriers to providing the best available care to patients with HCV infection.
"There is no medical rationale for excluding some HIV providers from prescribing HCV medications," said Donna Sweet, MD, AAHIVS, chair of the AAHIVM Board of Directors, an internist and HIV specialist. "HIV providers who have been treating HCV/HIV co-infected patients for years are uniquely qualified to manage potential drug toxicities and side effects stemming from combining treatment for HIV and HCV. These restrictive policies not only limit access to the new HCV treatment for many people with HIV but could lead to treatment disruptions and other serious adverse health consequences for patients."
While many new treatments have been developed for HIV patients over the last 20 years,
hepatitis C claims the lives of over 16,000 Americans annually. However, a new drug approved for the treatment of HCV earlier this year offers a significantly improved cure rate over older treatments.
"Thanks to the treatments available today, most of our patients with HIV do not die from AIDS-related illness, but from other conditions, including liver disease," said Joel Gallant, MD, MPH, FIDSA, chair of HIVMA and an infectious diseases and HIV specialist. "Many people co-infected with HIV and HCV have been waiting a long time for more effective and tolerable HCV treatment. Now that a cure is available, it is unconscionable to deny them access to medical providers who are well qualified to administer and manage this treatment."
AAHIVM and HIVMA have received reports of insurers instituting these policies from practicing HIV providers in several states. In an attempt to address the growing trend, AAHIVM and HIVMA have sent letters to insurers urging their immediate discontinuation and re-evaluation of these policies.
LINK to letter sent from IDSA & HIVMA to CMS-Medicare/Medicaid:
Download the PDF here
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August 19, 2014
Marilyn B. Tavenner, RN, Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8013
Baltimore, MD 21244-8013
Re: Medicaid Restrictions on Providers Treating HCV
Dear Administrator Tavenner:
In response to action taken by some State Medicaid programs to restrict the specialties of providers who can prescribe drug therapies to treat hepatitis C virus (HCV), the Infectious Diseases Society of America (IDSA) and the HIV Medicine Association (HIVMA) appeal to the CMS Administrator to recommend that Infectious Diseases (ID) Specialists and other HIV providers1 be covered prescribers of all HCV medications.
IDSA represents more than 10,000 infectious diseases physicians and scientists devoted to patient care, prevention, public health, education and research in the area of ID. The Society's members focus on the epidemiology, diagnosis, investigation, prevention and treatment of infectious diseases in the U.S. and abroad. Our members care for patients of all ages with serious infections, including people living with HCV, HIV and AIDS. Within IDSA, HIVMA represents more than 5,000 clinicians and researchers on the front lines of the HIV/AIDS epidemic whose clinical management and research on common comorbidities of HIV infection includes HCV and hepatitis B co-infection.
ID and HIV specialists are ideally positioned to address this "silent epidemic," leveraging the advances in the treatment of HCV with the emergence of protease inhibitor-based therapies that are similar to HIV treatment. ID specialists are leaders in all aspects of HCV as evidenced below.
A majority of the physician members serving on the FDA Antiviral Drugs Advisory Committee that makes recommendations regarding the approval of new HCV medications are ID specialists.
ID and HIV specialists conduct HCV-related clinical and basic research, and many acquired experience prescribing the new HCV medications to their patients enrolled in clinical trials that generated the evidence base for FDA approval.
ID and HIV specialists are intimately familiar with the mechanisms of action of these advanced therapies that are similar to those used to treat other infectious diseases, including HIV, and are well qualified to manage the complications that may arise with the regimens that call for combining these advanced therapies.
1 See Identifying Providers Qualified to Manage the Longitudinal Treatment of Patients with HIV Infection and Resources to Support Quality HIV Care. Updated March 2013. Online at http://www.hivma.org/Defining-HIV-Expertise.aspx.
Not all hepatologists have experience managing HCV, and many have little experience managing the complex care of HCV and HIV co-infected patients since a majority are cared for by ID or HIV specialists. In addition, HCV is an infectious disease that is eradicated with antiviral therapy. Infectious diseases providers are national leaders in the efforts to use anti-infective agents responsibly (stewardship) and are well positioned to ensure the most cost-effective use of these new medicines, much as they already do for other antimicrobial agents.
In the U.S., nearly 4 million persons are estimated to be infected with HCV and approximately half are unaware of their status. Approximately 20,000 individuals are newly infected each year.2,3 Research supporting the cost effectiveness of HCV screening led the U.S. Preventive Services Task Force's to elevate its HCV screening recommendations and the Centers for Medicare and Medicaid Services (CMS) to incorporate HCV screening coverage into the Annual Wellness Visit. Furthermore, the Department of Health and Human Services' (HHS) action plan for the prevention, care and treatment of viral hepatitis aims to raise awareness of this "silent epidemic" and reduce the number of new HCV infection cases in alignment with the Healthy People 2020 objectives.4
With the large burden of HCV in the general population, efforts to expand the availability and the clinical expertise of providers are an essential complement to more effective screening and in fighting this insidious killer. IDSA, in collaboration with the American Association for the Study of Liver Diseases (AASLD), is leading the way in providing timely clinical guidance (see http://www.hcvguidelines.org/). The guidance is a living document maintained to assist prescribers on the appropriate treatment for specific patient populations that covers or will cover which regimens to use, when and in whom to use them, and how to monitor HCV patients during and after treatment. Many of the guidance panel members are excluded from prescribing the new HCV medications according to the specialty restrictions that some Medicaid programs are implementing.
Given the scope and severity of the HCV epidemic, we consider denial of HCV care provided by ID and HIV specialists to be an unreasonable and unjustified limitation of access to high quality care for those who need it most. Therefore, we strongly urge CMS to support our appeal to state Medicaid programs to include ID and HIV specialists as authorized prescribers of drug therapies to treat HCV.
Barbara E. Murray, MD, FIDSA Joel Gallant, MD, MPH
President, IDSA Chair, HIVMA
2 Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus
infection in the United States, 1999 through 2002. Ann Intern Med 2006;144:705-14.
3 CDC. Surveillance for acute viral hepatitis-United States, 2008. Available at: http://www.cdc.gov/hepatitis/Statistics/2008Surveillance/index.htm.
4 "Combating the Silent Epidemic of Viral Hepatitis: Action Plan for Prevention, Care and Treatment of Viral
Hepatitis." Department of Health & Human Services. May 12, 2011. Accessed on August 4, 2014 at
CC: Cindy Mann, JD, Director, Center for Medicaid and CHIP Services
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