Three Proposals to Reform the 340B Drug Discount Program

WHAT IS 340B?

Section 340B of the Public Health Service Act, passed by the Congress in 1992, was intended to provide assistance to medical providers who serve poor, underinsured patients.¹ The 340B Program provides enrolled hospitals and other providers (340B-qualified entities) with deep discounts on the acquisition costs of outpatient drugs, whether those drugs are later administered by physicians or dispensed by pharmacies.² Reports suggest the original program has substantially expanded in recent years via newly qualified entities, affiliated clinics, and contract pharmacy relationships.

Through deep acquisition cost discounts, the original intent of the 340B program was to enable underfinanced medical providers (a variety of safety net clinics and selected hospitals and their affiliated clinics and pharmacies) to purchase otherwise expensive drugs for the outpatient treatment of their patients. By statute, the program does not require 340B entities to pass on the drug discounts to the patients they treat, nor to the insurance plans that cover those patients.² Neither does it require these entities to limit the patients who receive the discounted drugs to those who are poor and in need. Instead, 340B entities, alone or via their contract pharmacies, can dispense discounted drugs to all their patients (except in some cases those insured by Medicaid), and keep the profits they make when they bill insurers and patients for the drugs as if they had purchased them at full price.³ Because the discounts pertain to drugs delivered to all of a qualified entity’s patients, whether they are poor or have terrific insurance, 340B-qualified entities make money by treating patients who reimburse for drugs at rates well above the discounts mandated by the 340B program.

The 340B program is overseen by Health Resources and Services Administration (HRSA), which falls within the purview of the Secretary of HHS. Under current rules, HRSA requires qualified safety net clinics to report the volume of patients served, their vulnerability, and how specific revenue streams are being used to increase access to medical care or improved quality of care. However, other qualified entities—including hospitals and contract pharmacies—that make up the vast majority of the program’s current scope, do not face these same reporting requirements.

WHAT ARE THE PROBLEMS WITH 340B?

Critics speculate that the opportunity to profit from this provision has created an impetus for 340B-qualified hospitals to push the envelope on the program’s intent—by opening outpatient clinics or pursuing affiliations with outpatient clinics in affluent communities where most patients will be well-insured. By so doing, hospitals increase their opportunity to profit from dispensing discounted drugs while being reimbursed at retail rates, but divert from the goal of the program, which is to provide services to the poor. Two of us (Conti and Bach) empirically evaluated this contention, using nationally representative data on program participants in 2012, matched to US Census Bureau data on local communities’ socioeconomic characteristics. We found that 340B-qualified hospitals are expanding their base into communities that tend to be affluent and well-insured, consistent with the most profitable expansion strategy that counters the objectives of the program.⁴ It is uncertain whether these affiliations and mergers improve the outpatient care patients receive. It is clear, however, that these activities drive up costs of providing care—and ultimately, commercial insurance premiums—since hospital outpatient contracts tend to be much more generous than physician office contracts and charge facility fees on top of service charges to payers and patients.

Other work has examined how 340B qualification influences prescription drug dispensing patterns. If 340B hospitals are aiming to conserve resources and deliver high-value, low-cost care, prescribing should favor low-cost (often generic) drugs. But if 340B hospitals are aiming to maximize profits, they will tend to prescribe more expensive (often branded) drugs, because the profits from each prescription are based on the retail cost of the drug, with larger profits coming from more expensive drugs. These studies have shown that, in fact, contract pharmacies for 340B hospitals disproportionately favor branded, patent-protected drugs over generic therapeutic substitutes, overall, and within a therapeutic class—a pattern that does not appear to be driven by a patient’s clinical complexity alone.4 A 2015 Government Accountability Office (GAO) report corroborated these findings. In both 2008 and 2012, GAO estimated per beneficiary Medicare Part B drug spending, including oncology drug spending, was substantially higher at 340B hospitals compared with non-340B hospitals. On average, beneficiaries at 340B hospitals were either prescribed more drugs or more expensive drugs than beneficiaries at other hospitals.⁵

The scope of the program is currently so vast that drug prices are also driven up for all consumers. By definition, branded manufacturers hold monopoly power, and recent consolidation in the generics market has similarly concentrated pricing power. As these manufacturers face significant and expanding demand for discounts on the acquisition prices of these drugs, they are able to pass the costs of these discounts onto other payers.

In August 2015, HRSA released its’ proposed “mega” guidance regarding manufacturer and qualified entity participation in the 340B drug discount program.⁶ The proposal recommends several changes to the program, including tightening the definition of which patients are eligible for treatment with drugs acquired at 340B prices, and which physicians are eligible to administer or prescribe drugs acquired at 340B prices. However, the actual impact of this proposal remains uncertain, particularly because recent court rulings have created doubts regarding HRSA’s authority to implement their new standards.⁷

PROPOSED 340B REFORM STRATEGIES

Given that empiric evidence suggests that the pattern of the program’s expansion has been both, towards affluent populations of patients and more expensive drugs—which run contrary to the program’s goals of enhancing access for poor patients to cost-effective, high-value care—we believe it is a good time to consider revising the program. We have contemplated 3 possible steps that would enhance the program’s function and be more consistent with Congress’ original intent to enhance access for the poor to essential medical services.⁸

1. Redefine 340B qualification for hospitals and affiliated clinics based on the vulnerability of their outpatient population.

This would address the logical contradiction embedded in the current qualification criteria for disproportionate share hospitals and their affiliated clinics, which is that eligibility is based on the insurance status of their inpatient population, but the 340B discounts apply to drugs administered or dispensed in the outpatient setting. This disconnect creates the perverse incentive for hospitals to expand their reach away from poor patients even as they qualify for discounts, and therefore profits, that are intended to help them serve the poor.

2. Pass the 340B discount through to payers and patients, regardless of their insurance status.

The majority of patients currently being treated as outpatients at qualified entities are, in fact, insured. But 340B discounts, enjoyed by these entities, are not translated into discounts for their patients or for payers. If these discounts were passed along to the insurer and to the patient, both would benefit. This reform would improve access, lower patient out-of-pocket expenses, and lower health insurer costs, including those of Medicare. By requiring facilities to pass through the discounts, the profit potential of the program, which is driving rapid program expansion and medical practice consolidation, would be diminished while not disrupting the ability of the hospital to acquire drugs needed to treat poor patients at reduced costs.

3. Limit the distribution of discounted drugs to those patients who are of limited means, irrespective of their medical provider’s qualification for “safety net” status.

This reform would essentially transfer 340B eligibility from providers to patients. Patients could qualify for a 340B discount based on personal economic circumstances, irrespective of whether they are insured. This approach could employ tools currently used to qualify patients for discounted coverage in exchange plans and other types of government or private-assistance programs. Depending on need, the discounted pricing could be coupled to the current patient-level financial assistance in a single program, providing added help to those who need it the most. By tying the benefit to the patient most in need, the benefits could also travel with them, meaning that they would not be constrained to receive care at specified “qualified” providers if other medical providers in their communities are better for them.

EBO

Although the 340B program’s intent was clearly well meaning, and many 340B providers are doubtless pursuing the goals of the program, it is also clear that the program has become a profit center for participating hospitals, clinics, and contract pharmacies, distorting where patients receive care and driving up care costs, without any demonstrated improvement in quality of care. Given the distortions in the market, altering the program in the manners we have described: outpatient eligibility criteria, pass through of the discounts to patients, and portability of eligibility, are all sensible approaches that should be considered by policymakers. Rena M. Conti, PhD, is assistant professor of health policy and economics, Departments of Pediatrics and Public Health Sciences, University of Chicago.

Peter B. Bach, MD, MAPP, is director, Center for Health policy and Outcomes, Memorial Sloan Kettering Cancer Center.

Michael Kolodziej, MD, is national medical director, Oncology Solutions, Aetna.

Address for correspondence

Rena M Conti, PhD

Departments of Pediatrics Hematology/Oncology and Health Studies

The University of Chicago

5841 S Maryland Ave

Chicago, IL 60637

E-mail:

rconti@uchicago.edu

REFERENCES

1. Section 340B Public Health Service Act (Pub. L. 102-585). Health Resources and Services Administration website. http://www.hrsa.gov/opa/programrequirements/phsactsection340B.pdf. Accessed November 10, 2015.

2. US Government Accountability Office. Manufacturer discounts in the 340B Program offer benefits, but federal oversight needs improvement. http://gao.gov/assets/330/323702.pdf. Published September 2011. Accessed November 10, 2015.

3. Conti RM, Bach PB. The 340B drug discount program: hospitals generate profits by expanding to reach more affluent communities. Health Aff (Millwood). 2014;33(10):1786-1792.

4. Clark B, Hou J, Huang E, Chou C, Conti RM. The 340B drug discount program: outpatient prescription dispensing patterns through contract pharmacies in 2012. Health Aff (Millwood). 2014;33(11):2012-2017.

5. US Government Accountability Office. Medicare Part B Drugs. Action needed to reduce financial incentives to prescribe 340B drugs at participating hospitals. http://www.gao.gov/assets/680/670676.pdf. Published June 2015. Accessed November 10, 2015.

6. 340B Drug Pricing Program omnibus guidance. Federal Register website. https://www.federalregister.gov/articles/2015/08/28/2015-21246/340B-drug-pricing-program-omnibus-guidance. Published August 28, 2015. Accessed November 10, 2015.

7. 5 U.S.C. § 706(2)(A). Pharmaceutical Research and Manufacturers of America, Plaintiff, v United States Department of Health and Human Services, et al. No. 1:14-cv-01685-RC at 38. Filed October 14, 2015. Accessed November 10, 2015.

8. Conti RM, Bach PB. Cost consequences of the 340B drug discount program. JAMA. 2013;309(19):1995-1996.

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