Although the 340B drug pricing program was intended to lower out-of-pocket costs for patients, changing dynamics in the medical field have raised concerns among health care providers about whether the plan is working.
Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus Conference conducted research to understand how program operations have changed over time and how effective this effort is in reducing costs. highlighted the controversies surrounding the 340B drug pricing program, including the gaps in drug pricing. .
The session began with a brief history of the 340B program, summarizing its establishment in 1992 as part of the Public Health Service Act. The program requires manufacturers who sell covered outpatient drugs to other entities to charge a price that does not exceed an amount determined based on a statutory formula. Average discounts off list prices can exceed 50% and vary by drug.
Organizations eligible for this program include children’s hospitals, critical access hospitals, disproportionate share hospitals (DSHs), freestanding cancer hospitals, regional referral centers, sole community hospitals, as well as several grant recipients and Includes clinics (such as Native Hawaiian Health Centers). , sexually transmitted disease clinics, tuberculosis clinics).
In 1992, eligible entities were allowed to contract with a single pharmacy, and the program was very simple, says Roberts, president and CEO of the National Pharmaceutical Council and editor of the magazine. John M. O’Brien, Ph.D., MPH, who is also a member of the committee, explained. American Managed Care Journal®. Since then, companies have had to develop relationships not only with multiple pharmacies, but also with manufacturers, wholesalers, third-party administrators, pharmacy benefit managers, and pharmacy switching vendors, creating more complex systems and programs. It has generated controversy over growth, the certainty and clarity of its mechanisms. , lack of transparency regarding its mechanisms, and economic impact on various stakeholders.
DSH accounted for most of the 340 billion increase. Last year, the 340B generated $52 billion in savings and revenue, an increase of about $42 billion from 2015, but DSH accounted for 78% of that increase. However, there are many concerns about 340B transparency, making it difficult to conduct research for the program.
Dr. Donald E. Nichols, chief of Genentech’s Health Policy and Systems Research Division, said there was no guidance on how discounts would be reflected in eligible patient care and services, and no requirements on how to use them. They pointed out that there is no comprehensive understanding of whether discounts apply or not. The patient benefit portion of the program is working.
One study on patient discount sharing in the 340B program found that patient out-of-pocket (OOP) costs were reduced by approximately 92% within 1.4% of 340B eligible pharmacy claims using a 340B discount card. Although discounts can be shared at the point of sale at contract pharmacies, most eligible patients do not directly benefit from the program.
Another study on 340B eligibility expansion found that by adopting a more liberal continuum of care approach, the model estimates the potential to double sales of branded 340B drugs, while It was also shown that questions have arisen regarding purchasing behavior for generic drugs.
Nichols said health care providers are concerned about providing more charity care, increasing the amount and variety of medications and offering free vaccinations. However, empirical evidence shows that while there is mixed evidence of increases in charity care and medicine access services, there has been no increase in total community benefit spending or uncompensated care.
He said more research is needed to better understand how patients benefit from 340B and whether discounts are being systematically applied to vulnerable patients by: I pointed out.
- Reduce OOP costs
- Patient assistance program
- Services for vulnerable patients
- Less aggressive pursuit of debt
- more appropriate care
- Improving medication adherence
- better health outcomes
