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Policy Watch

Volume 25, December 18, 2013
Policy Watch is a newsletter for state and territorial health department staff that provides updates, analysis and highlights on the impact of national politics on HIV and viral hepatitis programs. Please visit NASTAD’s website at www.NASTAD.org for more information or contact Oscar Mairena or Emily McCloskey.

Legislative Updates
 
Bipartisan Budget Act of 2013
Congress passed and the President is expected to sign the Bipartisan Budget Act of 2013, a budget deal that establishes spending limits for FY2014 and FY2015 and partially replaces sequestration cuts for these years. The deal raises the spending level for non-defense discretionary funding by approximately $22 billion in FY2014. The law seeks to establish “regular order” for the appropriations process, allowing lawmakers to begin writing FY2014 appropriations bills.
 
Specifically, the Bipartisan Budget Act:
  • Divides sequestration relief evenly between defense spending and non-defense discretionary spending
  • Does not change sequestration cuts on or call for any reforms in mandatory spending and entitlement programs
  • Increases revenue through fees (e.g., airline traveler fees, user fees, federal employee pension contributions)
  • Does not address sequestration cuts from FY2016 to FY2021
It is still unclear what this deal will mean for HIV and viral hepatitis programs in FY2014. House and Senate appropriators have begun work on a funding package, but it is uncertain if the Labor, Health and Human Services, Education and Related Agencies (LHHS) bill will be funded as a continuing resolution (CR) or as part of an omnibus spending bill. If LHHS is funded as a CR, funding levels may be similar to FY2013. If it is funded as part of an omnibus, appropriators will have flexibility to target spending increases and cuts.  
 
PEPFAR Reauthorization
On World AIDS Day, the President signed into law S1545, the PEPFAR Stewardship and Oversight Act of 2013, which extends the President’s Emergency Plan for AIDS Relief Program (PEPFAR)’s funding authorities, limitations and allocations. In addition, the law calls for an oversight report on global HIV efforts and a study of treatment providers. The reauthorization of PEPFAR shows the United States’ commitment to continue global efforts. Additionally, the President also announced his continued commitment to contribute to the Global Fund to Fight AIDS, TB and Malaria and urged other world leaders to match the United States’ contribution.
 
HIV Organ Policy Equity (HOPE) Act
On November 22, 2013, President Obama also signed S330, the HIV Organ Policy Equity (HOPE) Act.  The law will permit organs donated by people who died who were HIV-positive to be used for transplantation into HIV-positive patients or for research purposes. The law, which passed the House and the Senate unanimously, calls on HHS and the Organ Procurement Transplant Network to develop and implement standards for research on HIV-positive organ transplantation to increase understanding of the safety and effectiveness of these procedures. 
 
REPEAL HIV Discrimination Act
This month, Senator Chris Coons (D-DE) introduced the Repeal Existing Policies that Encourage or Allow Legal (REPEAL) HIV Discrimination Act. The REPEAL Act calls for laws and policies that demonstrate a public health-oriented, evidence-based, medically-accurate and contemporary understanding of HIV transmission, risks of transmission based on means of exposure, current health implications of living with HIV and the benefits of treatment and comprehensive support services. This is the first time the REPEAL Act has been introduced in the Senate. For more on the REPEAL Act, see NASTAD’s blog.
 
Viral Hepatitis Testing Act
This month, Representatives Bill Cassidy, MD (R-LA), Charlie Dent (R-PA) and Brett Guthrie (R-KY) introduced HR3723, the Viral Hepatitis Testing Act. The bill seeks to increase resources for viral hepatitis testing, education, linkage to care and surveillance. However, the bill does not increase the Centers for Disease Control and Prevention’s (CDC) budget authority and proposes the use of the Secretary’s Evaluation Transfer, which currently funds a number of other public health programs. In the past, the Viral Hepatitis Testing Act has been introduced with bipartisan support, however, this iteration is, thus far, only supported by one party.
 
For a complete list of HIV-related legislation, please click here.
For a complete list of viral hepatitis-related legislation, please click here.
 
Administration Updates

HIV Research Initiative
In his World AIDS Day remarks, the President announced a redirection of $100 million within the National Institutes of Health (NIH) for a new HIV cure and vaccine research initiative. The President said the new initiative would seek to find a new generation of therapies that could eliminate HIV or put it into remission. 
 
HIV Care Continuum Initiative Report
The White House Office of National AIDS Policy (ONAP) released a report outlining the first recommendations and action steps from the HIV Care Continuum Initiative (the Initiative). In October, NASTAD provided comments and recommendations to ONAP and the Office of HIV/AIDS and Infectious Diseases Policy (OHAIDP) at the Department of Health and Human Services (HHS) on the Initiative. The ONAP report’s action steps include:
  • Supporting, implementing and assessing innovative models to more effectively deliver care along the care continuum 
  • Tackling misconceptions, stigma and discrimination to break down barriers to care 
  • Strengthening data collection, coordination and use of data to improve health outcomes and monitor use of Federal resources 
  • Prioritizing and promoting research to fill gaps in knowledge along the care continuum 
  • Providing information, resources and technical assistance to strengthen the delivery of services along the care continuum, particularly at the state and local levels.
Federal Agency Progress Updates
CDC published online the National HIV Prevention Progress Report and Progress At-a-Glance, a one-page companion. This new report describes progress toward achieving CDC’s key HIV prevention goals and the challenges that continue to threaten our success. The report highlights the continued need to address HIV among gay, bisexual and other men who have sex with men (MSM). The Health Resources and Services Administration (HRSA) released an infographic on the success of their Increasing Access to HIV Care and Treatment (IAHCT) initiative in surpassing its goal of enrolling and reengaging people into HIV care.
 
FDA Drug Approvals for Chronic HCV
The Food and Drug Administration (FDA) has approved two new drugs for chronic hepatitis C (HCV) infection. Janssen’s Olysio (simeprevir) is the third protease inhibitor to treat HCV in combination therapy. Gilead’s Sovaldi (sofosbuvir) is a first-in-class nucleotide polymerase inhibitor and the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Sovaldi also attained an HIV co-infection indication by the FDA and NASTAD’s ADAP Crisis Task Force will, therefore, negotiate with Gilead for sub-340 pricing for ADAPs. These drugs have a very high price and NASTAD is working in coalition with the Hepatitis Fair Pricing Coalition to address affordability and access issues with manufacturers. Both Gilead and Janssen, however, have generous patient assistance programs (PAPs) for these drugs.

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