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Growth of 340B program triggers ‘battle over big money’
The 340B Drug Pricing Program makes life-saving treatments available to low-income, uninsured and underinsured patients at extreme discounts.
Proponents contend the program — created as part of the 1992 Public Health Service Act — greatly improved access to comprehensive cancer care.
“When the program first started, the original intentions were pure and meant to help indigent patients in need,” Michael Diaz, MD, director of patient advocacy at Florida Cancer Specialists and Research Institute, told HemOnc Today.
Yet, critics suggest 340B has expanded well beyond its intended scope, increasing the costs of insurance and pharmaceuticals while inadvertently providing financial windfalls to eligible hospitals, which can retain the difference between a drug’s discounted price and its market value when the agent is administered to well-insured patients.
Michael Diaz
As debate rages about whether 340B simply provides participating hospitals with the resources necessary to better serve all patients or has created a loophole through which large medical centers can abuse the system, calls for reform to 340B have intensified.
“To return to how the program was initially intended, the definition of ‘patient’ and eligibility should ensure that patients can be treated in the best setting geographically available to them,” Diaz said. “In my opinion, the benefit should be attached to the patients, and not necessarily the institution.”
HemOnc Today spoke with several health care policy experts about how the 340B program has affected the hematology and oncology communities; the strain it has created between institution-based cancer centers, industry and independent oncology practices; and the ways in which the federal government may try to modify the program.
Good intentions
Under the 340B Drug Pricing Program, pharmaceutical manufacturers must provide certain outpatient drugs to eligible nonprofit hospitals at discounts ranging from 20% to 50%. The goal is to help institutions provide more services and treat more patients — particularly vulnerable populations — during an era of limited government funding.
“As is the case with many administrative approaches, the initial intent of 340B was meritorious and would help offset the cost of hospital-based care of populations of patients who often have great needs and consume considerable resources,” Donald L. Trump, MD, FACP, president and CEO of Roswell Park Cancer Institute and HemOnc Today’s associate editor for medical oncology, said in an interview.
Sandra M. Swain
Without 340B, MedStar Washington Hospital Center would not have its cancer center, Sandra M. Swain, MD, FACP, medical director of Washington Cancer Institute at MedStar Washington Hospital Center and past president of ASCO, told HemOnc Today.
“This is a very meaningful charity care policy that helps us offset our uncompensated care, the costs of which are pretty high here,” Swain said. “We’re able to take care of more patients because of the program.”
The 340B program does not require participating facilities to pass along reduced drug prices to patients.
Safety Net Hospitals for Pharmaceutical Access (SNHPA), a nonprofit organization that advocates for more than 1,000 health systems and hospitals that participate in the 340B program, conducted a survey of its members in February 2011. Sixty percent of SNHPA members responded to the survey.
Results showed 74% of member safety net hospitals used the discounts to reduce drugs prices in their outpatient pharmacies. All of the hospitals surveyed reported that the savings derived from the 340B program were important to their operations, and 83% of respondents indicated the savings helped maintain broader operations, including nonpharmaceutical services. The hospitals surveyed saved an average of $5.2 million in 2010 with 340B.
Hospitals should have to declare how much money they made through the 340B Drug Pricing Program and what they have done to provide services to benefit underinsured and uninsured patients, said Jeffery C. Ward, MD, medical oncologist at Swedish Cancer Institute Edmonds.
Source: Photo courtesy of Jeffery C. Ward, MD
However, many physicians question whether the benefits derived by hospitals surpass 340B’s original intentions.
“The program was initially developed, depending on who you talk to, to either help pay for the care of the indigent patient, or to help the hospital that takes care of a lot of indigent patients be able to provide services,” Jeffery C. Ward, MD, medical oncologist at Swedish Cancer Institute Edmonds, said in an interview. “That is a sticking point between hospitals and pharma.”
Others say hospital-based benefits are an integral part of the 340B program.
“It was created by a bipartisan Congress to help hospitals and other safety net providers that serve large numbers of low-income, vulnerable patients stretch their resources to help their vulnerable patient population,” Robert A. Chapman, MD, director of the Josephine Ford Cancer Institute of the Henry Ford Health System in Detroit, told HemOnc Today. “It was never intended solely as a pass-through to the uninsured. To limit the program in this way would effectively kill it.”
Critics, however, suggest the financial benefits are a key contributor to the rapidly rising popularity of 340B. The number of participating hospitals nearly tripled in the past decade, increasing from 591 in 2005 to 1,673 — or one-third of all US hospitals — in 2011, according to ASCO’s policy statement on 340B.
The Affordable Care Act (ACA) also expanded the definition of 340B-eligible entities to include free-standing cancer, community and critical access hospitals on the basis of their disproportionate share hospital (DSH) percentage. The total number of covered entities reached 16,572 in 2011, a twofold increase from 2001.
Due to the ACA’s expanded Medicaid rolls in certain states — a factor in the DSH percentage — many more hospitals might meet eligibility criteria.
“There will be fewer uninsured patients to take care of, and more qualifying hospitals to reap rewards based on their Medicaid DSH percentage,” said Ward, who chaired ASCO’s Payment Reform Workgroup when ASCO developed its 340B statement. “In theory, there will be less need for 340B, and more hospitals that qualify.”
Mergers and acquisitions
The availability of 340B drug discounts has dramatically altered oncology care in the United States.
“Oncologists work in a myriad of settings, including national oncology practices, private practices, hospital-based practices and academia,” Ward said. “Some oncologists are able to work because of 340B, and some of them feel very threatened by 340B. But the real battle brewing is between qualifying hospitals and pharma, and it’s a battle over big money.”
Hospitals that participate in 340B often acquire community-based cancer centers to extend their discounts within these sites.
A report published by Berkley Research Group, a consulting firm for pharmaceutical companies, indicated the number of physician-based oncology practices acquired by 340B hospitals and registered to the Office of Pharmacy Affairs database increased from 79 in 2009 to 166 in 2012.
“Some hospital systems have used 340B for the acquisition of practices in order to make money on the margin from this pricing program,” Samuel M. Silver, MD, PhD, MACP, FASCO, professor of internal medicine at the University of Michigan and HemOnc Today’s Health Policy and Value of Care section editor, said in an interview. “It was a business opportunity, and it is certainly an attractive economic driver for practice acquisitions that continues today.”
According to the Berkley report, 340B chargebacks for oncology-related products increased 250% between 2009 and 2012 due to acquisitions, new covered entity enrollments and increased prices. Further, 89% of acquired sites were located in areas with higher median income than the 340B hospital.
These data have prompted some to question whether acquiring hospitals are looking for profit.
“I don’t think 340B hospitals by and large are poaching practices,” Ward said. “Hospitals are not deliberately seeking out oncology practices in wealthy communities to buy. Those practices had already chosen to be in wealthy areas. You don’t find private oncology practices in low-income and distressed communities. You find them where the practice would do well.”
There may be positives on both sides of the equation, Diaz said.
Physician-based practices face financial strain due to lower reimbursements from the Medicare Modernization Act (MMA), cuts from CMS based on reductions in physician fee schedules, and sequestration.
“Hospitals may not want to have patients treated in an oncology clinic if it was not profitable through 340B,” Diaz said. “On the other hand, it’s becoming progressively more challenging to operate an economically viable independent medical oncology practice. As hospitals acquire independent medical oncology practices, these acquisitions allow the practice to function and bill as part of their new 340B hospital owner.”
Although some suggest 340B has been the driving force behind oncology mergers and acquisitions, there are other possible explanations.
“This is a critical time in oncology, yet it’s hard to practice medicine because of so many regulatory requirements,” Swain said. “Many physicians feel they’d rather come into a situation where someone else is dealing with the administrative work. Without these responsibilities, physicians are able to actually see their patients.”
Chapman agreed the health care system, not 340B, is forcing mergers and acquisitions.
“Integration of community-based physician practices and institutional providers has a long history that has been propelled by fundamental changes in our nation’s health care system,” Chapman said. “Managed care, integrated delivery systems, capitation and, more recently, accountable care organizations have all created financial and clinical incentives for physicians and hospitals to work more closely together, and these incentives have nothing to do with the 340B program.”
Roswell Park Cancer Institute is not eligible for 340B discounts, yet the institution still seeks to join forces with local clinics, Trump said.
“We are pursuing partnerships in our region with some success, and in our situation, it’s completely independent of any 340B considerations,” Trump said. “If you argue that 340B is the only reason such mergers happen, the fact that we are doing it argues against that. There are multiple reasons to look at different models for provision of care and organization, but it would be naive to suspect that 340B has no effect at all.”
Access to care
The trend toward acquisitions has prompted many physicians to question the effects on access to cancer care.
“There are many oncologists with great interest in the maintenance of purely private, independent practitioners, and they provide excellent care,” Trump said. “But as cancer care gets more complicated, and as patients rightly expect more coordinated and multidisciplinary care, a lot can be said for the development of cancer program systems. Consolidations and partnerships can enhance the quality of care.”
Ward, who used to be in private practice, shared a similar sentiment.
“I am in the same community as I was when I was in private practice, taking care of the same patients with the same staff, in a beautiful new hospital-based cancer center,” Ward said. “In western Washington, we were hurt hard by the MMA, and now there are only two oncology practices left that are in a truly private practice setting. But no communities have lost oncologists.”
Yet, Diaz — who practices in the largest independent hematology/oncology practice in the United States — said the 340B program may strain a practice’s ability to remain independent.
“There are private practices that are staying financially viable and are able to continue, yet there may be a 340B institution next door that says, ‘We want to develop a fully integrated oncology program. If you can, come work for us, otherwise we’re going to hire our own medical oncologists,’” Diaz said. “Sometimes oncologists may believe that they don’t have many options other than to join the hospital.”
As care continues to shift from clinics to hospitals, data indicate costs are increasing.
An IMS Institute for Healthcare Informatics report, published earlier this year, found reimbursement levels for drug administration costs increased 189% in hospital outpatient facilities compared with physician offices.
A Berkley Research Group white paper, released in June, estimated that Medicare paid an additional $23.29 million and Medicare beneficiaries paid an additional $4.05 million due to the increased cost of chemotherapy claims in hospital outpatient departments vs. physicians’ offices.
“When community oncology clinics are closed, they are frequently replaced with a more expensive hospital-based system,” Diaz said. “In some instances, those without the 340B capability to offset costs are letting the practices they’ve acquired go because they aren’t able to run them at a profit. We may see the repercussions of this downstream, and unfortunately it may result in more centralized care.”
Patients with benign hematologic conditions also need to be considered, Silver said. 340B has a special category for the inclusion of hemophilia, AIDs and other specialized clinics.
“Before we do reform, it is essential we understand how 340B impacts other vulnerable patients, such as hemophiliacs, those with Von Willebrand’s disease or patients with chronic immunodeficiency,” Silver said. “It’s important that hemophilia clinics and infusion centers consider how 340B fits into their practices because these patients are not on treatment for months, like cancer patients who receive chemotherapy. These patients receive very expensive drugs for decades.”
Although costs may be increasing on average, more patients receive care.
“We take care of patients who have no money, who basically don’t pay anything or who are on Medicaid, and who wouldn’t be taken care of in a private practice,” Swain said. “I don’t know where these patients would go if we didn’t have the ability to take care of them with 340B.”
‘Mega-Reg’ reform
The Department of Health and Human Services’ so-called “Mega-Reg” outlining potential 340B reforms was expected in June. However, it was delayed because Congress determined HHS did not have authority to implement a proposed provision that would have allowed the use of orphan drugs at discounted prices for non-orphan indications.
This ruling may mean that HHS releases less expansive rules, but changes are still expected, Diaz said. Many physicians hope increased regulation is a key component in the reform effort.
“There need to be more guidelines in place, the lack of which has prompted the criticism of the program,” Swain said. “There is no clear guidance, especially with regard to the satellite offices of 340B hospitals. Are the people in practice treating underserved patients? Are they giving uncompensated care?”
The first audit of participating hospitals did not occur until 2012. Of the 51 hospitals audited that year, 24 received sanctions. Some of those sanctions ordered hospitals to repay manufacturers. Of the 19 hospitals audited in 2013, two received sanctions.
ASCO’s statement also called for revisions to program oversight.
“The hospital should have to declare how much money they have made through the program, and what they have done to provide services to benefit the underinsured and uninsured patients,” Ward said.
Reform also likely will redefine the term “qualified patient.” Critics say the current definition — which states the patient must have established care with the covered entity — is tenuous.
“Some hospitals are casting a very broad net as to how they define which patients from whom they can collect 340B drug prices,” Ward said. “An example is a patient who has an ER visit, but their primary and oncology care is provided by clinics not affiliated with the hospital. Does that hospital have the right to collect 340B funds on that patient? I don’t think so. But according to the rules, there is nothing to say they cannot.”
Stringent reform may address the DSH percentage to determine hospital eligibility. Critics suggest there is incongruity between the formula — which is based on Medicare inpatients — and the program intended for outpatient care.
“This is a flawed metric that allows the opportunity for a hospital to qualify for 340B and collect money on all of their paying patients while they continue to send all of their indigent care elsewhere for therapy,” Ward said. “This hasn’t been rampant in the program, but there have been anecdotal accounts of this happening.”
However, others say the DSH percentage is the appropriate measure to determine hospital eligibility.
“Congress created the 340B program to lower drug costs for safety net hospitals and other providers that serve large numbers of low-income, vulnerable patients, including Medicaid patients and low-income Medicare patients,” Chapman said. “Disproportionate share hospitals must have a DSH adjustment percentage greater than 11.75% to be in 340B, which roughly translates to about 30% of a hospital’s case load being Medicaid or low-income, elderly Medicare beneficiaries who qualify for the Supplemental Security Income program.”
Reformers should be cautious, Swain said.
“If you cut the program, this will deeply affect a lot of people with cancer,” Swain said. “Lawmakers need to look at this very carefully and consider how many vulnerable Americans need these cancer services that the 340B program has made possible.”
Because the 340B program as currently structured allows hospitals to profit from their participation, there may be few cases where criticism is warranted, Ward said.
Nevertheless, such loopholes heighten the calls for reform.
“It’s fair to question whether the original intent of the 340B pricing program is currently carried out,” Silver said. “People all the time in business, whether in hospitals or other entities, regularly make use of loopholes as part of their business plan. This is typical US business. When we start to see these loopholes causing unintended consequences, then it’s time to relook at the laws and redefine them.” — by Alexandra Todak
Click here to read a Letter to the Editor regarding the debate on the 340B program
References:
Alliance for the Integrity and Reform of 340B. Unfilled expectations: An analysis of charity care provided by 340B hospitals. Available at: 340breform.org/userfiles/Final%20AIR%20340B%20Charity%20Care%20Paper.pdf. Accessed Aug. 1, 2014.
Berkley Research Group. 340B covered entity acquisitions of physician-based oncology practices. Available at: www.brg-expert.com/publications-vandervelde-340B-oncology.html. Accessed Aug. 1, 2014.
Berkley Research Group. Impact on Medicare payments of shift in site of care for chemotherapy administration. Available at: www.brg-expert.com/media/publication/454_Site_of__Care_Chemotherapy.pdf. Accessed Aug. 1, 2014.
CMS. Federal Register. Available at: www.ober.com/files/FedReg2013-10234.pdf. Accessed Aug. 1, 2014.
IMS Institute for Healthcare Informatics. Innovation in cancer care and implications for health systems: Global oncology trend report. Available at: www.imshealth.com/portal/site/imshealth/menuitem.762a961826aad98f53c753c71ad8c22a/?vgnextoid=f8d4df7a5e8b5410VgnVCM10000076192ca2RCRD. Accessed Aug. 1, 2014.
Mitchell JM. N Engl J Med. 2013;369:1629-1637.
Safety Net Hospitals for Pharmaceutical Access. Demonstrating the value of the 340B program to safety net hospitals and the vulnerable patients they serve. Available at: www.snhpa.org/images/uploads/340B_Value_Report_06-29-11.pdf. Accessed Aug. 1, 2014.
Tomkins JE. J Oncol Pract. 2014;doi:10.1200/JOP.2014.001432.
For more information:
Robert A. Chapman, MD, can be reached at Henry Ford Hospital, 2799 W. Grand Blvd., Detroit, MI 48202.
Michael Diaz, MD, can be reached at Florida Cancer Specialists, 1201 Fifth Ave. North, #505, St. Petersburg, FL 33705.
Samuel M. Silver, MD, PhD, MACP, FASCO, can be reached at 4118 Med Sci 1, SPC 5624, 1301 Catherine St., Ann Arbor, MI 48109-5624; email: msilver@umich.edu.
Sandra M. Swain, MD, FACP, can be reached at Medstar Washington Hospital Center 110 Irving St. NW, Washington, DC 20010; email: sandra.m.swain@medstar.net.
Donald L. Trump, MD, FACP, can be reached at Roswell Park Cancer Institute, Elm & Carlton Streets, Buffalo, NY 14263.
Jeffery C. Ward, MD, can be reached at Swedish Medical Center Edmonds, 21632 Highway 99, Edmonds, WA 98026.
Disclosure: Chapman, Diaz, Silver, Swain, Trump and Ward report no relevant financial disclosures.
Has the 340B program increased costs of cancer care for patients?
The widespread use of the program likely inflates the prices of oncology drugs for all consumers.
Rena M. Conti
As a larger number of drug sales become eligible for 340B discounts — and thus fewer drugs are sold at full price — drug manufacturers likely will seek to increase drug list prices for all purchasers. Drugs used to treat cancer are an increasingly important group of drugs being purchased through the 340B program and also are major revenue producers for drug manufacturers. Thus, drugs used to treat patients with cancer likely are targets of 340B-related price increases. This increases national spending on cancer care.
I have two other concerns about how the 340B program is implemented.
First, the program likely produces substantial profit disparities between oncologists and other medical providers who do and do not qualify for the discounts. One report suggested profits generated through the prescribing of a single medical oncologist practicing at 340B hospital-affiliated outpatient clinic could reach $1 million per year. Purchasing cancer drugs is a major cost center for outpatient oncology practices and profits derived from using these drugs are critical to practice sustainability. Consequently, the disparity between 340B “haves” and “have nots” may act to reduce the availability and accessibility of cancer care in some communities.
Second, the program’s benefits may create an impetus for some 340B entities to strategically expand into caring for affluent, well-insured patient populations, enhancing the profitability of participating hospitals while eroding the core goals of the program. The incentive most likely is operative among Disproportionate Share Hospitals, where strategic merger and affiliation activities would allow them to generate profits off distributing drugs to affluent, well-insured patients without jeopardizing their qualification for the program under current rules. In a recent study, myself and coauthor Peter B. Bach, MD, MAPP, provide the first empirical evaluation of this contention. We use nationally representative data on 340B program participants matched to US Census Bureau data on local communities’ socioeconomic characteristics in 2012. Our results strongly suggest that increasingly the affiliated clinics of 340B-registered Disproportionate Share Hospitals and affiliated clinics are serving affluent and well-insured communities.
Given this, I believe policy makers have two options to provide support for medical providers serving the most vulnerable patients while eliminating the 340B program’s unintended consequences. Hospitals and their clinic affiliates could be limited to providing drugs they obtain at 340B discounts to only those patients who are poor, uninsured or underinsured. Alternatively, hospitals and their clinic affiliates could be required to pass on their savings from drug purchases to patients and their insurance providers.
Rena M. Conti, PhD, is an assistant professor of health economics and policy in the University of Chicago’s departments of pediatrics and health studies. She can be reached at rconti@uchicago.edu. Disclosure: Conti reports no relevant financial disclosures.
References:
Conti RM. JAMA. 2013;309:1995-1996.
Pollack A. Drug Industry says 340B Discount program is being abused. Available at: www.nytimes.com/2013/02/13/business/dispute-develops-over-340b-discount-drug-program.html?emc=eta1. Accessed Aug. 1, 2014.
Section 340B of the Public Health Service Act (Pub. L. 102-585). 340B Drug Pricing Program & Pharmacy Affairs Program Requirements. Available at: www.hrsa.gov/opa/programrequirements/phsactsection340b.pdf. Accessed Aug. 1, 2014.
Multiple factors other than the 340B Drug Pricing Program impact the total cost of cancer care and patient costs.
They include cancer type, stage, site of care, diagnostic and treatment modalities, co-morbidities, health care provider requirements, regional variations in care, inadequately designed payment models and coverage disparities.
When discussing cancer care costs, it is important to consider:
The evolving environment.
The Medicare Modernization Act, beginning in 2005, decreased drugs and increased administration reimbursement for community-based oncology providers, resulting in a cancer care shift to consolidated physician networks or integrated health systems.
The Affordable Care Act also brought changes with Medicaid expansion, health insurance mandates and new ACO Medicare payment models, with provisions to expand to other payers. ACOs are compensated through an arrangement that combines payment with financial incentives to reduce costs and improve quality.
Payment reforms continue for both Medicare and commercial payers exploring bundled payments. These models bring providers and insurers together rather than being on opposing teams.
The value of integrated care and improving data transparency and research.
During the past decade, health systems adopted evidence-based cancer guidelines, as well as shared decision-making regarding treatment and end-of-life care, to reduce costs and improve patient outcomes and quality of life. In addition, they have adopted use of health information systems and exchanges aimed at improving communication among providers, enhancing safety, and reducing duplication of testing and inadequate treatment selection.
Variations in patient costs.
Some of the causes of increased costs of care include cancer treatments that require surgery, adjunct therapies that require hospitalization, the use of highly toxic medications and therapy complications that require additional treatment. Variations in care cost for patients also are tied to personal care decisions, insurance benefit design and regional and practitioner variations in care.
Some recent publications try to blame hospitals for increased out-of-pocket costs for patients who need cancer care, but they lack sufficient evidence across payers and fail to acknowledge other factors at play. Politicians, patient advocates, health plans, health systems, physician practices and others are exploring ways to improve access and quality while reducing costs.
Value of innovation.
While evolving drug therapies and tele-monitoring offer potential to decrease costs and increase effectiveness of cancer management — including the feasibility of safely managing patients in their homes — new medication costs may be higher.
So, what’s the truth? There’s no doubt that cancer costs are increasing, with many drug treatments costing up to $10,000 per month or more. However, it seems surprising that the 340B program is being singled out for increasing the costs of cancer care, including patient costs, when there are clearly a number of forces responsible.
Health care is continually evolving; thus, rather than finger-pointing at times of transition between models of care, stakeholders should come together to develop strategies to continue to make quality care accessible and affordable to patients while maintaining financial sustainability.
Holly Russo, RN, BSMHR, MSN, MS, is chief nursing officer of Sentry Data Systems. She can be reached at hrusso@sentryds.com. Disclosure: Russo reports no relevant financial disclosures. The opinions expressed are hers and do not necessarily reflect the views of Sentry Data Systems.
References:
Cantlupe J. HealthLeaders Media. Bundled payments come to cancer care. Available at: http://www.healthleadersmedia.com/page-5/FIN-289965/Bundled-Payments-Come-to-Cancer-Care##. Accessed Aug. 4, 2014.
Goodman D. Trends and Variations in End of Life Care for Medicare Beneficiaries. Available at: http://www.dartmouthatlas.org/downloads/reports/EOL_Trend_Report_0411.pdf. Accessed Aug. 1, 2014.
IMS Institute for Healthcare Informatics. Innovation in cancer care and implications for health systems: Global trend report.
Medicare Payment Advisory Commission. Accountable Care Organizations. Available at: http://www.medpac.gov/chapters/Jun09_Ch02.pdf. Accessed Aug. 4, 2014.
Shea AM. Duke Clinical Research Institute. Chemotherapy after the Medicare modernization act: have changes in reimbursement policy affected access to care. Available at: http://www.npaf.org/sites/all/themes/NPAF/images/pdfs/final_duke_study-chemotheray_after_the_mma_sept2007.pdf. Accessed Aug. 4, 2014.
US Department of Health and Human Services. The HMO Cancer Research Network. National Cancer Institute.
Wang L. Turning Tides: Trends in Oncology Market Access. Campbell Alliance. Available at: http://www.campbellalliance.com/articles/Campbell%20Alliance%20-%20Turning%20Tides%20-%20August%202012.pdf. Accessed Aug. 1, 2014.
Warren I. J Natl Cancer Inst. 2008;100:888-897.
Perspective
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Instead, some hospitals are abusing the program as a profit source. PhRMA remains committed to the original goal of helping patients gain better access to medicines; however, the program should be recalibrated to ensure it remains sustainable for the patients who need it. Research has shown that many 340B hospitals are providing very little charity care to the uninsured and yet they are accessing 340B discounts, raising questions about how some entities are using the discounts for purposes other than improving access and expanding services for uninsured and vulnerable patients.
What’s more, in the last 3 years, the number of contract pharmacies participating with 340B hospitals has grown by 700 percent. However, there is no empirical evidence that these pharmacies improve access for uninsured, indigent patients. In fact, evidence shows that the majority of these pharmacies do not know at the time of dispensing whether a patient is eligible for the 340B discount, meaning the uninsured patients are likely not being provided access to discounted medicines in most contract pharmacies.
In the past 10 years, the 340B program has doubled in size, and despite the Affordable Care Act increasing the number of insured Americans, the program is still expected to continue to grow at historical rates — all while a growing body of research shows that the 340B program has deviated from its core goal of serving the uninsured and vulnerable. As former Health and Human Services Secretary Kathleen Sebelius noted, the program has “expanded beyond its bounds,” and it is time for congressional and administrative oversight and reform. We look forward to working with stakeholders to strengthen the program for those it was intended to help: uninsured and vulnerable patients.