State ADAPs use the funds they get from HRSA to make medications to treat HIV disease accessible to individuals who otherwise couldn’t afford them – the cost of AIDS meds can soar to $15,000 and more a year. ADAP funds also may be used to buy medications to prevent or treat other opportunistic infections that could threaten an ADAP patient’s health.

ADAP funding has grown tremendously to keep pace with new medications approved by the Food and Drug Administration that prolong life for those living with HIV/AIDS. Over the past decade HRSA’s ADAP appropriation has increased from $52 million in FY 1996 to $790 million in FY 2006. In FY 2004, 142,653 clients were served through State ADAPs.

Grants are awarded according to a formula based on AIDS prevalence among states and territories. Three percent of the total ADAP appropriation is reserved for supplemental grants to states and territories with demonstrated severe need. And up to 5 percent – and in some cases 10 percent – of ADAP funds may be used for services that improve access to medications, increase adherence to drug regimens, and help clients monitor their progress in taking HIV-related medications. ADAP grants also may be used to buy private health insurance for eligible clients if it includes prescription drug coverage.

In addition to the Federal funds from HRSA, state ADAPs also may receive funds to buy drugs from their respective states and other CARE Act programs. State and local contributions to ADAPs in 2004 totaled approximately $226 million.

States and territories have the autonomy to establish their own criteria for ADAP eligibility. All require that individuals document their HIV status and some require a CD4 count – a blood test that measures the strength of an HIV-positive person’s immune system – of 500 or less. Most ADAP clients have incomes at 200 percent or less of the Federal Poverty Level – another criterion used by several ADAPs.

State and territorial ADAPs also have the autonomy to decide which medications will be made available and how those medications will be distributed to enrollees. State ADAP formularies – or lists of approved drugs – range in size from 17 to 453 drugs. Many programs automatically add medications when they are approved by the Food and Drug Administration. Almost all states cover 30 or more AIDS-fighting drugs.

Five types of HIV antiretroviral medications have been approved by the FDA:

• nucleoside reverse transcriptase inhibitors (NRTIs);
• nucleotide reverse transcriptase inhibitors (NtRTIs);
• non-nucleoside reverse transcriptase inhibitors (NNRTIs);
• protease inhibitors (PIs); and
• fusion inhibitors.

With dramatic decreases in AIDS mortality as a result of treatment advances over the past 15 years, ADAPs are pressed to serve more and more clients whose lives are extended by drug therapies. In states and territories where demand outstrips resources, cost-cutting measures have been adopted. These include capping client enrollment – which results in the creation of waiting lists to access ADAP medications – eliminating drugs from formularies, establishing protocols for accessing certain drugs such as antiretroviral medications, and limiting per patient expenditures.

To help address the problem of waiting lists, President Bush has asked for an additional $70 million in his FY 2007 budget to provide care and medications to those newly diagnosed with HIV or AIDS as a result of increased testing efforts.

With the incidence of new HIV infections staying constant at more than 40,000 a year, ADAPs will continue to be challenged to provide medications to new clients, to cover the cost of new treatments, and to maintain high standards of care.

The good news is that in the third decade of AIDS, people are living with and managing their disease. And with HRSA’s help, life-saving medications are getting into the hands of those who can least afford them and giving them hope for longer, healthier lives.

The legislation intends to trim nearly $100 billion from the Federal budget over the next 10 years. Of that amount, the Congressional Budget Office estimates that savings of $28.3 billion will come from Medicaid as states are given new flexibility to redesign certain aspects of their programs.

Two major changes, both of which took effect March 31, give states more autonomy than they had previously in imposing premiums and cost-sharing, within limits, and in redesigning benefits for Medicaid recipients.

Although the DRA for the first time gives states the option to allow health care providers to deny services to patients who do not pay premiums or co-payments, it limits the impact on existing Medicaid-eligible groups by exempting certain populations, including children, pregnant women and institutionalized persons. Premiums are only permitted for families earning more than 150 percent of the Federal Poverty Level (FPL) and cost-sharing above nominal limits is only permitted for families earning more than 100 percent of FPL.

Similarly, in allowing states to redesign benefits for certain Medicaid recipients who were covered prior to the law’s Feb. 8, 2006, enactment, the DRA holds that the redesigned plans must offer “benchmark” or benchmark-equivalent health coverage. Those include the standard Blue Cross Blue Shield plan within the Federal Employee Health Benefits Program, coverage offered to state employees, and coverage offered by the state’s largest Health Maintenance Organization (HMO).

In both cases, the changes states make to their Medicaid programs as a result of the DRA may impact health centers and other safety-net providers whose income relies heavily on Medicaid reimbursements. If, for example, Medicaid beneficiaries treated at health centers lose coverage when they are unable to pay state-imposed premiums or higher co-payments, health centers would lose revenue. Medicaid payments made up 34.7 percent of centers’ total revenue in 2005.

And states that decide to use their new ability to make rapid changes in Medicaid through “state plan amendments” – instead of seeking exemptions through Federal waivers – could decide to enroll their Medicaid caseload into a “benchmark” HMO. Such a decision could move a significant portion of a health center’s Medicaid patients into the HMO’s closed network of providers.

Fortunately, protections for health centers in the DRA could encourage states to let health centers continue to serve their Medicaid patients with higher reimbursements under the Prospective Payment System. Those higher reimbursements would reflect the more comprehensive and cost-effective array of services that health centers provide.

Two other important changes to Medicaid in the DRA include new citizenship documentation requirements, which become effective July 1, 2006, and emergency room diversion programs, which take effect Jan. 1, 2007.

The DRA will prohibit states from receiving Federal Medicaid matching funds for services to individuals who cannot prove their U.S. citizenship by producing a birth certificate, passport, or other forms of identification specified in the legislation. If, as expected, Medicaid enrollment rates fall as a result of the new requirement, health center grantees will likely lose paying Medicaid patients. They also may gain uninsured patients, as people who were formerly covered under Medicaid seek care at health centers, which must serve everyone regardless of their ability to pay.

The law also gives states the ability to impose higher co-payments on Medicaid recipients who use emergency rooms (ERs) for non-emergency services. The hospital copays apply only if an alternate source of non-emergency care is available and the name and location of the alternative is provided at the emergency room. Health centers could gain Medicaid patients if beneficiaries who go to ERs for non-emergency care are referred to health centers, which then become the patient’s medical home. Community health centers are explicitly cited as an alternate option in the DRA. The DRA provides $50 million over four years for demonstration projects to help organizations develop ER diversion programs.

The April 18 “virtual” seminar, presented by members of Health Management Associates under contract to HRSA, used teleconference technology that allowed HMA experts speaking in Michigan, Florida and Indiana to be seen and heard by staff at HRSA headquarters in Rockville, Md., and by regional staff in Philadelphia and Kansas City.

For additional information on the Deficit Reduction Act, access the actual legislation, a cost estimate from the Congressional Budget Office, and an analysis by the Kaiser Commission on Medicaid and the Uninsured.

THE WHITE HOUSE
WASHINGTON

March 13, 2006

I send greetings to all those observing National Minority Health Month.

America's health care system is the best in the world, and it is helping millions of Americans live longer and better lives. Our Nation is making progress toward groundbreaking cures for diseases, and we will continue to pursue medical research that is ambitious, aggressive, and ethical. By working together, we can advance medicine and bring comfort and hope to those in need.

I believe that access to primary and preventive health care services is critical, especially in medically underserved communities. Since taking office, I have worked to expand the reach of Community Health Centers to better enable them to serve these communities. My Administration has funded more than 800 new or expanded centers and will fund approximately 400 more in the next two years.

My Administration has also been active in addressing health issues of special concern to minority communities. To help lower the high rates of stroke in minority populations, the Office of Minority Health in the Department of Health and Human Services participates in the Community Initiatives to Increase Risk Awareness and Eliminate Stroke. These initiatives support awareness and education campaigns, encourage blood pressure screenings, and emphasize blood pressure control. Similar initiatives are underway to address the risks of diabetes, heart disease, and other issues that affect all Americans, but pose special risks to minority communities in particular.

During my 2006 State of the Union Address, I asked the Congress to reform and reauthorize the Ryan White Act and provide new funding to improve distribution of AIDS medicines in America. We will also lead a nationwide effort to deliver HIV tests to millions, end the stigma of AIDS, and work to end the spread of this disease in our country.

I appreciate all those who promote excellence and integrity in health care. Your efforts improve the health and well-being of our citizens and help make our Nation stronger.

Laura and I send our best wishes.

The employees were placed in the bureaus of Primary Health Care, Health Professions and Healthcare Systems and in the offices of Rural Health Policy, Health Information Technology and Federal Assistance Management (OFAM).

Also on May 1, all grantees whose programs were unfunded began reporting to the Grants Closedown Unit located in OFAM.

The Closedown Unit will have three staff members who will rotate in and out throughout the process.

The closedown period covers the time during which final program and financial reports are due.

On May 16, Dr. Duke hosted a "New Beginnings" party to celebrate the successful completion of the reassignment process.

“The goal of this project was to ensure that the parties that use this tool get timely, accurate access to the data they need to support the program,” according to Sharley Chen, an Office of Pharmacy Affairs (OPA) analyst who helped coordinate the upgrade.

Pharmaceutical manufacturers and wholesalers use the database to verify organizations’ eligibility to receive discounted pharmaceutical products.

The 340B program limits the cost of covered outpatient drugs to safety-net organizations, or “covered entities.” These entities are typically already Federal grantees such as health centers or qualified disproportionate share hospitals. Covered entities achieve significant savings on pharmaceuticals, often in the range of 20 to 50 percent.

Accurate information is crucial to establish eligibility, particularly the covered entity's exact name and street address. It is the responsibility of each covered entity to provide OPA with up-to-date information. Covered entities that are new to the program must contact OPA to register their intent to participate.

Once eligibility is established, covered entities can receive pharmaceuticals at the 340B discounted price beginning with the next calendar year quarter. It is the entity's responsibility to tell its wholesaler or manufacturer that it is registered for 340B discount prices when it places an order.

The database upgrade was in the works for several years and addresses concerns voiced by users regarding their ability to access information in the database. Manufacturers and wholesalers expressed a desire for more timely and accurate information on covered entities participating in the program.

OPA also canvassed a cross-section of people who work with the data for their input on making the database more user-friendly.

The result: more information is available online than ever before. Users can more easily identify information on the site and statistical reports reflecting program data were added for the first time. These reports track growth and changes in the program, giving users a more accurate sense of where the program is going. The improved reports also let manufacturers and wholesalers know why previously covered entities have left the 340B program.

Although the database is more complex and full-featured, it is also easier to use, according to Chen. Users can get the information they want, and exclude what they don’t want, she said. Users can also download historical and current information about 340B-covered entities in Excel and PDF files.

For more information on HRSA’s 340B Drug Pricing program, access their website, or call the HRSA Pharmacy Services Support Center at 800-628-6297.

The HRSA Healthcare Quality Council (HcQC) was established last August to move the agency closer to achieving Goal 3 of HRSA’s 2005-2010 Strategic Plan: improve the quality of health care. The creation of the HcQC reflects the Department’s own emphasis on quality in its strategic plan and a continuing focus on the need to improve quality in health care from the Institute of Medicine and the Institute for Healthcare Improvement, among many other groups.

The HcQC consists of HRSA associate administrators and deputies who meet quarterly to review and respond to reports from three council workgroups: Patient Safety, Clinical Effectiveness and Health Literacy.

The HcQC is organizing its work around the four Goal 3 objectives. In the first objective – promoting the effectiveness of health care services – the council is developing a “Quality Roadmap” to plan how HRSA will integrate quality improvement activities, concepts and strategies into agency programs.

In the second objective – promoting patient safety and improving patient protections – the council is taking inventory of current HRSA-supported human subject research studies, determining their cost, and documenting evidence of Internal Review Board approval of the sponsoring research institutions.

For the third objective – promoting access to, and appropriate use of, health care information – the HcQC is developing a health literacy training for grantees that will be piloted at HAB all-grantee meeting, providing technical assistance to HRSA staff, and working with the HRSA Information Center to distribute appropriate health care information.

In the final objective – promoting the implementation of evidence-based methodologies and best practices – the council is working to identify HRSA-wide, evidence-based, patient-level core clinical performance measures for grantees.

Each of the three workgroups is assessing a different aspect of quality or patient safety. The Patient Safety workgroup will recommend actions that promote patient safety and improve patient protections for HRSA’s vulnerable populations. The Clinical Effectiveness workgroup is developing the core clinical performance measures for grantees and designing the Quality Roadmap. And the Health Literacy workgroup will focus on increasing access to quality care by raising health literacy awareness within HRSA and among external partners.

Currently, the HcQC is reviewing the first round of clinical performance measures. Once approved, the measures will be returned to the Clinical Effectiveness workgroup for implementation.  The first group of measures will be piloted by the Office of Performance Review, which will offer them to grantees to use voluntarily in site visits next year by OPR staff. In June, the HcQC will receive the first draft of the Quality Roadmap and an update on the progress of the workgroups.

The Initiative, announced by the President within two weeks of taking office in 2001, promotes the full participation of people with disabilities in all areas of society by increasing access to assistive and universally designed technologies, expanding educational and employment opportunities, and promoting increased access into community life.

The FY 2006 awards will help improve access to quality, comprehensive and culturally competent care for children and youth with special health care needs (CYSHCN) and their families. An estimated 13 percent of U.S. children have special health care needs, defined as requiring care and services beyond those of most children. HRSA’s Maternal and Child Health Bureau leads the nationwide effort on behalf of CYSHCN under the New Freedom umbrella.

The awards will benefit CYSHCN by:

• helping families partner with health care providers in making medical decisions;
• getting special needs children into a “medical home” for regular medical visits and referrals for specialty care;
• helping provide adequate private or public medical insurance coverage;
• enabling early and ongoing screening and surveillance;
• encouraging easy-to-use community-based services; and
• providing youth with special needs services for transition to adult life.

Six grantees won State Implementation Grants for Integrated Community Systems worth $1.8 million. Grantees will work with state Title V programs to put plans in place to integrate all of the six core objectives listed above into a health care system that makes it easier to serve CYSHCN. Needs assessments and data collection and analysis will aid in the process.

The six awards, each worth $295,500, went to the Navajo Nation in Window Rock, Ariz.; the Maine Department of Health and Human Services; Trustees of Dartmouth College in Hanover, N.H.; Health Research, Inc., through the New York State Department of Health; the North Carolina Department of Health and Human Services; and the Rhode Island Department of Health.

Organizations in six states (Florida, Illinois, Maine, Minnesota, Tennessee and Vermont) will each receive $100,000 grants to support Family-to-Family Health Care Information and Education Centers for Families of Children with Special Health Care Needs. These centers, run by families in partnership with State Title V agencies and other providers, help families navigate the health care and social services systems by offering health and related information to families and providers, assisting families in gaining access to and using community services, and providing leadership training to family members.

President Bush’s FY 2007 budget proposal includes $3 million in grants for the Family-to-Family centers under the Family Opportunity Act of 2000. That legislation allows states to offer middle-income families of children with disabilities the option of buying into Medicaid.

Additionally, national resource centers in Utah and Maine each received $400,000 in cooperative agreements to work with policymakers, community groups, families and state Title V programs to improve services to CYSHCN in community health care systems. The funds also will help CYSHCN access other services to help them live independent lives and enter the adult workforce.

The awards went to the National Resource Center for Inclusive Community Integrated Services at Utah State University and the Healthy and Ready to Work National Resource Center at the Maine Department of Health and Human Services.

The latest effort, Administrator's Handbook: Training & Implementation of BFWHW Physical Activity and Healthy Eating Guides, contains information on how to train health care providers to implement the previous guides in a clinical setting, using a PowerPoint presentation.

The goal of the Bright Futures for Women initiatives is to promote physical, emotional, social and spiritual health and well-being among women across the life span through the use of culturally competent tools. Materials from the series can be found at www.hrsa.gov/womenshealth.