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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

Living with cancer takes a toll on anyone, but it can be especially devastating for uninsured and low-income patients. That’s why the 340B Drug Pricing Program is such an important issue. Congress created this program in 1992 to help improve access to medical services for this population. The program works by providing discounted prescription drugs to hospitals and clinics that serve high numbers of uninsured, low-income patients. Since the program’s creation, however, concerns have grown about whether the 340B program has strayed from its original purpose.

Putting patients first is one of the core ideas that guide the Colon Cancer Alliance’s mission. The 340B program was designed with this idea in mind, so we advocate a return to that intent. Currently, the program works by providing discounts to eligible treatment facilities – there is no requirement that those facilities reinvest the cost savings into services for needy patients, so hospitals can benefit greatly from 340B’s discounted drugs. Treatment and prescription decisions, though, should always be made with a focus on the patient’s best interest, not the financial interest of the treatment facility.

The 340B program must be held to a greater standard of accountability. Improving transparency and increasing oversight of the program would go a long way toward that goal. The number of facilities participating in 340B has grown 93% over the past decade, however the number of Health Resources and Services Administration (HRSA) staff overseeing the program has decreased by 9% since 2008. HRSA currently relies heavily on program participants self-policing, which is hardly adequate. Furthermore, participating facilities should be required to fully and transparently account for the cost savings gained from 340B discounts, so that those resources can be verifiably reinvested in care for uninsured, low-income patients.

Clarifying the eligibility requirements to participate in 340B would be another good step. For instance, there are currently contract pharmacies that are able to use the 340B discounts. These for-profit entities reap the benefit of the discounts for their bottom line rather than passing the savings along to patients. It has also become evident that the majority of 340B hospitals are providing less charity care than the national average, which includes for-profit establishments.The regulations should be tightened so that 340B drugs are dispensed only to eligible patients, rather than to any patient of an eligible facility.

Implementing any of these changes would help refocus the 340B Drug Pricing Program toward its original intent of increasing access to care for needy patients. It is of great importance to our patient community that the program be reformed to benefit the people who really need it – patients. To learn more about this issue, visit www.340breform.org.

Eric Hargis
CEO, Colon Cancer Alliance

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Eric Hargis
CEO, Colon Cancer Alliance

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Mr. Eric Hargis joined the Colon Cancer Alliance as CEO in January 2014.  Hargis has more than 35 years of relevant leadership experience in national health organizations and has a proven track record of supporting these entities through strategic growth. Hargis has a proven track record of being a transformational leader.  Nationally, he has successfully led the development of numerous programs, partnerships, events and fundraising initiatives.

Daily, Hargis beats the drum that colon cancer is largely preventable and a unique cancer that we can actually do something about.  His passionate approach is intentionally driving the mission of the Colon Cancer Alliance to the forefront of a national health movement.  He is active in FDA committee hearings advocating for innovations in screening, meeting with congressional representatives to provide supportive insight and securing national corporate partnerships. 

Hargis graduated with a degree from the University of San Diego.  He lives in Maryland with his wife and two children.

The Colon Cancer Alliance’s mission is to knock colon cancer out of the top three cancer killers. This mission is being accomplished by championing prevention, funding cutting-edge research and providing the highest quality patient support services. Learn more at ccalliance.org.

 

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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

Affordability and accessibility to lifesaving medicines is something we can all agree is important, especially among low income Americans and the indigent care population.

The federal 340B program, enacted in 1992, to address this issue, has helped countless uninsured and vulnerable patients gain access to the vital treatments needed to live healthy and happy lives. As a way to improve and ensure access to prescription drugs for Medicaid patients, the program requires prescription drug manufacturers to provide discounts to specified facilities as a condition for their participation in the Medicaid program.

However, since the 340B program’s inception the program has undergone changes and has increased in terms of both size and scale. We believe Congress is right to question whether the program is still meeting the intended goals as outlined in its creation more than 20 years ago.

We remain concerned that the stated goals of the program are not presently being met and are supportive of efforts for reviewing the 340B program to ensure patients who depend on these lifesaving medicines are not only receiving them but can afford them as well. A recent AIR340B report took note of the fact charity care represents less than 1 percent or less of the total cost of providing care to patients at about one-quarter of 340B hospitals. Further, less than a third of 340B hospitals are providing more charity care than the average for all hospitals combined, including for-profit hospitals. This statistic, coupled with the fact that two-thirds of 340B hospitals provide less charity care than the average U.S. hospital should raise alarm bells.

Our organization recently signed a letter with other leading Texas medical associations recommending the 340B program establish clearer oversight, accountability, and transparency. We noted:

At the end of the day there are far too many individuals who depend on this vital program to receive their medicines at an affordable rate. We owe them a better program and the keeping of the promise of 340B’s original intent. 

Texas BioAlliance
Partner, 340B Contributor

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Texas BioAlliance
Partner, 340B Contributor

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Texas BioAlliance is assisting entrepreneurs and researchers in all therapeutic areas in creating commercially viable companies that can take promising technologies from the bench-top to the bedside.

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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

Life science companies are creating a better Kentucky.  Not only are they creating jobs and building companies, but they do so while producing products that literally save Kentucky lives.  From Owensboro to Lexington, Universities to the private sector, we work together to make a difference in the commonwealth.  Whether it is a nurse in a rural clinic, a doctor in a major urban hospital, or a biotech researcher in a lab, they are all working to make people healthier. However, as is too often the case, good intentions are trumped by competition for the all-mighty dollar.

That is what is going on with a little-known but important drug pricing program called 340B, which Congress created in 1992 to ensure that pharmaceutical companies shared in the cost of providing care to the uninsured. For the last 20 years, the federal 340B has helped biopharmaceutical companies and hospitals partner to share treatments and medicines at a discounted price with those who could not otherwise afford them.  The program has helped millions of uninsured and vulnerable patients gain access to the treatments necessary to lead fuller — healthier lives.

However, the existing 340B program lacks an effective oversight mechanism to ensure the discounted treatments are reaching their intended recipients. The lack of oversight has led to an explosion in growth in the program – but not necessarily to the benefit of patients. As noted in the recent AIR340B report, charity care represents less than 1 percent or less of the total cost of providing care to patients at about one-quarter of 340B hospitals and less than a third of 340B hospitals are providing more charity care than the average for all hospitals combined, including for-profit hospitals.

The 340B program provides funding to share in the cost of treating patients. But the devil lives in the details, and 340B can and should be improved. This good government program — originally intended to serve a limited number of hospitals — has exploded beyond its intent to become a major profit driver for thousands of hospitals across the country.

And the kicker is that while some hospitals can reap massive profits from participating in this program, patients, whether insured or not, often receive no direct benefit in terms of lower cost.

Unfortunately, lax government oversight has led to abuse by some hospitals and the large chain pharmacies with whom they contract. The federal Health Resources & Services Administration (HRSA), which administers the program, has traditionally provided little oversight for key program elements, including how hospitals report whether a patient is actually qualified to receive indigent care.

This means hospitals are paying the significantly reduced 340B rate for most of their outpatient drugs while charging insured patients’ insurance companies the full amount and then keeping the difference as profit.

Caring for the uninsured population costs hospitals a tremendous amount of money and they deserve help from others in the healthcare industry, like pharmaceutical companies. At the same time, America’s biotech research companies lead the way in innovation to create medicines that treat illnesses and cure disease and need the necessary funding to continue their critical work as well.

In order to make the 340B program sustainable and fair, we need oversight, transparency, and a recognition that the way it is operating now is just not right. Surely there’s a way to achieve this, serve the poor, and improve this part of America’s health care system.

 

Kyle Keeney
Ph.D., KLSC

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Kyle Keeney
Ph.D., KLSC

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An inveterate explorer and educator, Dr. Keeney has over 20 years experience as an entrepreneur and executive in Silicon Valley, NYC, and Kentucky. Educated at Georgetown College, Baylor University, with a Ph.D. in complexity modeling from Temple University, Dr. Keeney is a visionary leader able to balance market context, academic rigor, and solid innovation with organizational capacity and constraints. Unbound by conventional thinking, He leads organizations down new and rewarding avenues to meet objectives for revenue and growth. Dr. Keeney has a long and distinguished client list including working with the American Management Association, Applied Materials, Bayer, Eli Lilly, IBM, Johnson & Johnson, Sun Microsystems, USAF, and the Pentagon.

Kyle’s other passions include painting, yoga and fly fishing. Occasionally, he is known to put on the hats of a university professor in epistemology and corporate strategy consultant.

With dreams of a cabana in Latin America, Dr. Keeney makes his home in Louisville, KY with his wife, raising their two daughters. He can be reached at kylekeeney@usa.net.

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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

The good news is that lawmakers in Washington are now taking steps to ensure that this program works as it was intended to. And with 15 percent of the population in the United States – some 24 percent in Texas – lacking health insurance, let's hope these policymakers are successful.

The idea of 340B is a noble one. Drugs are an incredibly effective way to improve patient health. But even with passage of the Affordable Care Act and Medicare Part D, many Americans still lack access to medicines. The poverty rate for Texans, 17 percent, is higher than the national average. For this group of Americans, 340B is critical.

Unfortunately, there is no guarantee that 340B is helping those who need it most. Given the loose guidance around how the program works, hospitals that participate in 340B can purchase medicines at deeply discounted prices, resell them to patients at full price and pocket the difference.

The Health Resources and Services Administration (HRSA) recently released the results of the first-ever audits of 340B. Officials found that 51 participating hospitals aren't actually eligible. Three major providers admitted to benefiting from discounts they didn't qualify for and agreed to reimburse drug manufacturers. Last year, HRSA de-certified over 350 entities from participating in the program because they no longer qualified.

Despite its massive structural flaws, 340B has been expanded significantly in recent years. Over the last eight years, the number of hospitals enrolled in the program has tripled. Today, one-third of our nation's hospitals now participate.

Meanwhile, recent tweaks to 340B have also allowed participating hospitals to expand the number of outside "contract" pharmacies they use to distribute drugs. Between 2010 and 2013, the ranks of such pharmacies grew by nearly 700 percent. In theory, one might consider this expansion a way to reach more people.  But many of these pharmacies serve communities that are mostly affluent and insured. Just like some of the participating hospitals, some of these contractors frequently sell 340B drugs at full price to uninsured patients and pocket the difference.

Texas Nurse Practitioners is dedicated to promoting and supporting quality health care through leadership, education and advocacy.  We strongly support the mission of the 340B program.  In practice, however, it has gone awry.  Fortunately, a group of federal lawmakers is stepping up to the plate to fix the program.  We applaud this effort, as they have called on HRSA to immediately improve oversight and ensure the 340B program assists those it is meant to serve.

Michael Hazel
President, Texas Nurse Practitioners

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Michael Hazel
President, Texas Nurse Practitioners

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Michael Hazel, DNP, APRN, FNP-BC, is the president of Texas Nurse Practitioners (TNP), of which he has been a member for the past ten years. For the last five years, Hazel served on the executive board of TNP in various roles including Treasurer, Vice President and President-Elect.

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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

The Coalition of Texans with Disabilities has been advocating on behalf of people with disabilities since 1978. We believe individuals with disabilities should be able to participate fully in all aspects of society. This includes employment, transportation, and healthcare. We have been working hard to ensure these individuals are able to continue to contribute to and be a part of society.

There are, however, many roadblocks to achieving this goal. Many with disabilities have medical costs that exceed those of the average individual. Disabilities can also hinder job opportunities. According to statistics from the U.S. Department of Labor, the unemployment rate among Americans with disabilities is approximately double that of the national average. These individuals have higher costs and fewer job opportunities.

The federal 340B program was designed to help lower healthcare costs considerably by offering discounted drugs to healthcare institutions that would pass on the discounts to individuals who could not afford treatment. Many of the individuals who receive this benefit are those with disabilities. We want to protect the sustainability of this program because it helps to defray the healthcare costs of Americans living with disabilities.

This program is extremely important to vulnerable patients. However, the program has greatly veered from its original intent, which was to ensure that necessary, affordable medicines reach those who otherwise would not have access. The passage of the Affordable Care Act has increased the number of healthcare facilities operating under 340B. A report recently issued by the Alliance for Integrity and Reform of 340B (AIR340B), however, has found that 69 percent of the facilities operating under 340B have charity care rates below the national average of all hospitals.

Even with ACA coverage for more Americans, 340B is expected to grow exponentially – and not necessarily to the benefit of vulnerable patients.  Recently, questions have been raised about the program and whether it is meeting the goals Congress outlined for it over 20 years ago, namely to ensure uninsured indigent patients gain better access to prescription medicines.  Given the value and importance of the 340B program, it is important to reform it. However, reform should not come in the form of lower quality services or higher prices to patients. The 340B program needs more oversight to ensure that the healthcare facilities are protecting access and passing along discounts to the intended recipients. Abuses of 340B can endanger access – and that is unacceptable.

With 22 percent of the facilities providing approximately 80 percent of the charity care, we also need to clarify the qualifications needed to become a 340B facility. We need to reform 340B to return it to its original intent. By providing more oversight we will cut costs, but not patient benefits. By keeping the patient benefits in place we will help to ensure that disabled individuals can continue to work, live, learn, play and participate fully in society.  Abuses of 340B can endanger access--and that is not acceptable.

CTD
Partner, 340B Contributor

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CTD
Partner, 340B Contributor

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Founded in 1978, the Coalition of Texans with Disabilities is the oldest and largest member-driven disability advocacy organization in the state. We take a multi-front approach to making Texas a leader in disability-related public policy and culture.  Our work revolves around legislative advocacy, public awareness events and activities, and professional services.

 

CTD envisions a future where all Texans with disabilities can work, live, learn, play, and participate fully in the community of their choice.

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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

The Society for Women’s Health Research is the nation’s only nonprofit organization whose mission is to improve the health of all women through research, education and advocacy. We believe that the 340B program is vital to ensuring that indigent women in the United States have access to quality health care and medications. SWHR is concerned that a recent report seriously calls into question whether that mission is being realized.

More than half of the 37 million Americans living in poverty today are women and approximately 18 million women lived in poverty last year. Additionally, an estimated 44 percent of those women lived in extreme poverty, meaning that they have income levels that are at or below 50 percent of the federal poverty level. These women rely on charity care to receive the appropriate medical care for themselves and their families.

To that end, SWHR finds it extremely discouraging that, as referenced in the report, charity care represents less than 1 percent or less of the total cost of providing care to patients at about one-quarter of 340B hospitals and less than a third of 340B hospitals are providing more charity care than the average for all hospitals combined, including for-profit hospitals. These findings directly contrast with the program’s original intentions.

The 340B program was established as a very important safeguard for indigent Americans, especially women, to receive the care they need. SWHR believes the 340B program should be reformed to reflect the original intent of Congress and to ensure that patients who qualify under the program retain access to the health care and medications they need. We strongly encourage 340B hospitals to re-examine their charity care practices to achieve this goal.

 

 

SWHR
Society for Women’s Health Research, 340B Contributor

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SWHR
Society for Women’s Health Research, 340B Contributor

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The Society for Women’s Health Research (SWHR) is the thought leader in research on biological differences in disease and is dedicated to transforming women’s health through science, advocacy, and education.

Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that uniquely affect women. Thanks to SWHR’s efforts, women are now routinely included in most major medical research studies and scientists are considering gender as a variable in their research.Read the full history.

Today, SWHR advocates for greater public and private funding for women’s health research and the study of biological differences that:

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How can we assure that the 340B program provides access to discounted medicines to the indigent and vulnerable patients the program was designed to serve?

The North Carolina State Grange has been an advocate for rural North Carolina since 1929. We believe that all citizens should have access to quality healthcare that is affordable. We further believe that lower income individuals should receive financial assistance with acquiring needed medications. The 340B program enacted by Congress was intended to provide the necessary support for the vulnerable and uninsured to have access to medications. However, a study conducted by Avalere Health Alliance for Integrity and Reform 340B Coalition suggests that many hospitals enrolled in the 340B program may not be fulfilling the intent of the program.

The report entitled “An Analysis of Charity Care Provided by 340B Hospitals” found that a large percentage of hospitals have charity care rates that are below the national average for all hospitals. More specifically, the national average for charity care rates is 3.3%. The report found that 69% are serving fewer charity cases than the national rate.

The NC State Grange is concerned that so many 340B hospitals appear to be providing such a small amount of mandated charity care. We are further concerned that hospitals may be profiting from the 340B program because they are serving a low population of needy individuals. These health care institutions are able to purchase medicines at a deeply discounted rate through the 340B program, but it appears that a large portion of these drugs are sold at full price.

We are thankful that we have quality hospitals to serve our citizens, and we recognize that profits are necessary in order to remain in business. However, the NC State Grange wants to ensure that patients are being properly served through the 340B program and that there are no abuses to the system. We do not want patients to experience increased costs or experience any other barriers that could prevent qualifying individuals from access to the program.

It is imperative for hospitals to be completely transparent regarding their care rates and profits associated with the 340B program. We further urge Congress to provide scrutiny and consider an overhaul of eligibility requirements for hospitals in order to eliminate problems.

The North Carolina State Grange
Contributor, The North Carolina State Grange

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The North Carolina State Grange
Contributor, The North Carolina State Grange

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The North Carolina State Grange serves as a family-oriented organization committed to serving its members through a variety of programs and services. The Grange promotes agriculture as an essential industry for our economy. Grassroots involvement in governmental issues is promoted through the development of legislative policy and through the encouragement of political participation.

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