Remarks to the Hemophilia Alliance

---

by HRSA Administrator Mary K. Wakefield

Baltimore, MD
September 14, 2010

---

Thank you for inviting me to be here with you today.  I’ve been told that I’m the first HRSA administrator to participate in your meeting, and I want you to know that I’m very pleased to share this time with you.  

As both the HRSA administrator and as a nurse, the focus of your work is clearly important and I value the opportunity that we have at HRSA to strengthen our partnership, on behalf of individuals and families that cope with these serious conditions.

I know you represent Hemophilia Treatment Centers that receive grants through our Maternal and Child Health Bureau.  And since your centers are eligible to receive 340B discount drugs through our Healthcare Systems Bureau’s Office of Pharmacy Affairs, you know HRSA from that angle, too.

While these are direct links between our programs and your centers, I’d also like to take a few minutes to tell you about the rest of HRSA’s major programs and activities.  You may be surprised about the range of HRSA’s reach, and hopefully you’ll see potential avenues for collaboration with some of our other programs and people.  At least indirectly, many of them touch or care for individuals with hemophilia.

HRSA is an agency of the U.S. Department of Health and Human Services, with a budget of $7.8 billion. We are the primary federal agency responsible for improving access to health care services for people who are uninsured, isolated, in rural areas, or medically and economically vulnerable.

• Our network of 1,100 community health center grantees across the nation – one of them, Mark, in your city of Fargo – provides primary health care at more than 7,900 sites, ranging from large medical facilities to clinics and mobile vans. Health centers serve nearly 19 million patients, about 40 percent of whom have no health insurance. Charges for services are set according to income, and only nominal fees are collected from the poorest patients.  People with hemophilia are, of course, welcome to seek treatment at health centers for their primary care needs.  Health center staff often works in consultation with appropriate sub-specialists in cases requiring additional resources.
• We also administer the Ryan White HIV/AIDS Program, whose 900 grantees provide top-quality care to more than a half-million low-income and uninsured people living with HIV/AIDS.  That’s about half of all people in the United States living with this disease, and we work through local programs and every state, including, of course, the states each of you hails from.
• We help ensure the adequacy of the health care workforce – physicians, nurses, dentists, etc. – by supporting curriculum development and through scholarship and loan repayment programs offered by our Bureau of Health Professions.  And, through our National Health Service Corps, we place primary care professionals in medically underserved areas, where they're needed most. The Corps provides scholarships and student loan repayments worth up to $50,000 in exchange for two or more years of service in shortage areas, both urban and rural.
• We also house the Office of Rural Health Policy, which funds efforts to bolster rural hospitals and coordinate health care among coalitions of rural providers and linkages between rural and urban providers.
• We work to increase and improve the use of telehealth to meet the needs of underserved people, especially those living in rural and remote areas.  We define telehealth as the use of electronic information and telecommunications technologies to support long-distance clinical health care, health-related education, public health and health administration.  For many of our communities, this technology has improved and, going forward, can help to markedly improve access to health care services – potentially in service to the patients for whom you care, for example.
• We also oversee the nation’s Poison Control Centers; federal Organ Procurement and Donation efforts; and the National Vaccine Injury Compensation Program, among many other programs.

Today at HRSA we’ve acquired a new important focus, and that’s the implementation of provisions of the Affordable Care Act, the historic health care reform legislation President Obama signed in March.  HRSA is the lead agency overseeing more than 50 different authorizations under the Act, and the co-lead agency on 16 others.

We believe the legislation helps Americans both immediately and in the longer term on many levels.  And many of the elements that make the Act so valuable to the general public are particularly significant to members of the hemophilia and bleeding disorders community.

• For example, as of later this month (as early as September 23, 2010), insurance companies will be prohibited from imposing lifetime dollar limits on essential benefits like hospital stays.  This key consumer protection will be especially beneficial to the people you serve.
• Starting this year, job-based health plans and new individual plans won’t be allowed to deny or exclude coverage for children (under age 19) based on a pre-existing condition, including a disability.  What a relief to families!  And in 2014, these same plans won't be allowed to deny or exclude anyone or charge more for a pre-existing condition – including a disability.

There are many more benefits of the legislation:

• Starting as early as this month (September 2010), people with children under age 26 can generally insure them if their policy allows for dependent coverage. The only exception is if your children can get their own job-based coverage.
• Insurance plans must develop guidelines to provide preventive care and screenings for infants, children, and adolescents, and these plans may not impose any cost-sharing requirements on those services.  One important message of HRSA’s Bright Futures initiative is that children with special health care needs still need all of the well-child and preventive care that every other child should have, even when the immediate treatment focus is on a particular disease such as hemophilia.
• Starting in 2014, if your income is less than the equivalent of about $88,000 for a family of four today, and your job doesn’t offer affordable coverage, you may get tax credits to help pay for insurance.

You can get this and much more information on the Affordable Care Act online, through the www.healthcare.gov portal.  I go there to get the facts on the legislation, and I suggest you go there, too.

But it’s much more than a source on the Affordable Care Act.  You can go to healthcare.gov to compare the value of insurance plans available in your state, to compare the performance of nearby hospitals, and to learn about ways to stay healthy.  The site is totally geared to the needs of consumers, and it’s remarkably easy to navigate.  In addition, it has been structured to evolve and expand as consumers use it and comment to Website administrators on ways to improve it.  Remember: www.healthcare.gov.

Children have especially benefited from initiatives advanced during President Obama’s now 20 months in office.  Beyond the gains I just mentioned, we learned recently that a record number of children have health insurance, thanks mainly to the expansion of the Children’s Health Insurance Program that the President signed soon after he took office.  That action extended coverage to an additional 2.6 million children during FY 2009, and it was the primary reason the percentage of children without health insurance dropped from 10 percent in 2008 to about 8.2 percent last year.  That percentage of uninsured kids is the lowest level ever.

As I indicated a minute ago, HRSA has been given broad responsibilities under the Affordable Care Act.  Let me touch on some of our major new tasks.  Most prominently, the Act provides $11 billion over the next five years for the operation, expansion and construction of health centers throughout the nation. This followed the $2 billion infusion of funds for health centers in last year’s Recovery Act, which was a just-in-the-nick-of-time infusion, given the economic downturn with job losses and associated losses of health insurance coverage for individuals and families.  We expect the expansion of sites and services under the Affordable Care Act to nearly double by 2015 the number of patients currently receiving care at health centers.  

In addition, the Affordable Care Act continues and expands investments in the health care workforce, particularly in primary health care.  For the National Health Service Corps alone, the Act authorizes and appropriates $1.5 billion through 2015.  This follows the $300 million invested in the NHSC in the Recovery Act.  These additional funds are adding thousands of nurse practitioners, oral hygienists, psychologists, dentists and physicians to the ranks of the NHSC.
HRSA also is investing Affordable Care Act funds totaling more than $200 million from the Prevention and Public Health Fund in health professions training programs to counter projected workforce shortages.  These funds, when added to the $200 million invested in health professions under the Recovery Act, will produce thousands of new nurses, nurse practitioners, primary care physicians, physician assistants and others by 2015.

The new legislation also extends HRSA’s current Family-to-Family Health Information Centers program by appropriating $5 million each year through FY 2012.  These centers are non-profit organizations that help families of children and youth with special health care needs and the professionals who serve them.  The new funding will help families:

• Learn about and secure adequate insurance coverage and benefits;
• Navigate the health care system ; and
• Understand the information needed to discuss needs with their health care providers.

As with other HRSA programs, these could be important organizations to help extend the reach of your work.

As these and many more investments from the Affordable Care Act take hold, they will increase access to health care providers and health care services – not just for people with hemophilia and bleeding disorders, but for all Americans.  People in large and small communities across the country will enjoy far greater access to high-quality primary health care available at HRSA-supported health centers, and the health professions investments will go a long way to meeting higher demand for their services as health insurance becomes more accessible for everyone.

Finally, I imagine you know that the Affordable Care Act altered our oversight of the 340B drug pricing program by expanding the definition of covered entities to include:

• Children’s Hospitals
• Critical Access Hospitals
• Free Standing Cancer Hospitals
• Rural Referral Centers and:
• Sole Community Hospitals.

To date, HRSA has enrolled approximately 200 newly eligible hospital sites in the 340B program.  We expect to enroll thousands of new hospital and health center sites.

Also related to the 340B program, HRSA is charged with implementing provisions regarding pricing integrity, data accuracy, and the ability to resolve pricing issues more efficiently and effectively.  

One of the requirements that will impact 340B covered entities directly is the new annual recertification mandate.  We’re early in that process, but rest assured that we will work with you and consult with you as things move forward.

Even before President Obama signed the Affordable Care Act, we’ve worked to increase patient access to 340B medications by allowing multiple contract pharmacies.  The policy that formerly limited 340B sites to a single pharmacy was changed in March of this year.  As a result, we’ve seen contract pharmacies grow from 2,650 in April to 3,436 in September, an increase of 30 percent in just 4 months.  This expansion by the Administration will allow patients greater and more convenient access to drug therapy, resulting in improved drug utilization and better health outcomes.

Specific to Hemophilia Treatment Centers, HRSA’s 340B prime vendor, Apexus, has been working with the Hemophilia Alliance to help participating centers secure sub-340B pricing through the Prime Vendor Program.

Apexus and the Alliance are collaborating to ensure that covered entities serving the hemophilia community have access to the best possible products and pricing through specialized contract expertise and supplier relationships.  The partnership takes advantage of both the Hemophilia Alliance’s unique expertise within the blood factor market and niche suppliers, and the unique expertise Apexus has in contract negotiation and administration in the 340B market.

I understand Apexus has secured sub-340B pricing with two blood product suppliers and is in negotiations with a third.   Out of the 103 Hemophilia Treatment Centers registered for 340B, 43 have signed up for the Prime Vendor Program.  Collective contract savings for these 43 Centers will exceed $2 million this year.  The savings for blood products equates to 3 percent below 340B pricing.

Apexus will be soliciting a bid for IVIG this fall and continues to work with the Hemophilia Alliance in securing other blood products and drugs that treat hemophilia-related conditions.  (Note: IVIG, or intravenous immune globulin, is a blood product widely used in HTCs for blood disorders.)

I pose to you this question: If 43 treatment centers save a collective $2 million this year through the Prime Vendor, shouldn’t we push to make sure that more centers enrolled in 340B also take advantage of Prime Vendor savings?  And for that matter, why are only 103 of the 132 centers enrolled in 340B?  Virtually all of the Centers should be participating, shouldn’t they?  I really hope we can get the Hemophilia Alliance together with HRSA staff in the Office of Pharmacy Affairs and the Maternal and Child Health Bureau to make this happen.

Speaking of Hemophilia Treatment Center grantees, we expect to announce in November or December a new competitive cycle of FY 2011 awards totaling about $4.8 million.  These four-year agreements will continue our support of your work.  In this cycle, we’ll ask grantees to focus on a number of priorities:

• First, to strengthen communication and collaboration among individuals, families and primary care providers, and among public health, hematologic and genetic medicine experts;
• Second, to evaluate project outcomes.  One big element of the Affordable Care Act is its emphasis on evidence-based health care.  To maximize quality care and cost-effective care, we need to understand what works and then we have to disseminate those ‘best practices’ wherever they can and should be applied.
• Third, we want grantees to begin the process of using telehealth to improve outreach in rural areas.  Some Hemophilia Treatment Centers currently use this technology, but we are encouraging more of you to use it to connect with patients in rural areas and lower the cost per patient served.  As I mentioned earlier, this expertise resides in HRSA.  Let your program officer put you in touch with HRSA’s telehealth staff.  They’ll be happy to help you.

As your program and the 340B program continue and evolve in the wake of the Affordable Care Act, we’ll be present with resources to help.  For example, last Thursday (9/9) we convened a technical assistance call between the 12 Regional Centers and Office of Pharmacy Affairs staff regarding 340B recertification.

And we are proceeding with a technical assistance call to grantees – now scheduled for October – that will cover topics such as the MCHB performance measures, the use of a Life Course approach to health care, and evaluation techniques.

Let me conclude by mentioning one more HRSA initiative – the Patient Safety and Clinical Pharmacy Services Collaborative, led by HRSA’s Office of Pharmacy Affairs.  This initiative focuses on changing features of health care delivery to high-risk patients across the nation.  Its aim is to improve patients’ health by eliminating adverse drug events through increased clinical pharmacy services.

Teams participating in the Collaborative have reduced rates of potential adverse drug effects by 60 percent and adverse drug effects by 49 percent.

The Collaborative is entering its 3rd year and more than 130 community-based teams are now participating.  We value these teams as our partners to improve health outcomes and patient safety, and we invite the Hemophilia Alliance and Hemophilia Treatment Centers to be part of this initiative.

So if you are interested in joining what we call PSPC 3.0, email us at patientsafety@hrsa.gov. Krista Pedley and Jae Choi in the Office of Pharmacy Affairs will gladly get you up to speed for the upcoming learning year.

Thank you for listening and, on behalf of HRSA and this Administration, sincere thanks to each of you for everything you do on behalf of the health of the nation.  We greatly appreciate your efforts and our ability to support you and partner with you.

I’ll be happy to answer any questions you may have.