The 340B Drug Pricing Program: Keeping Up with Changes

Staying abreast of changes to the 340B Drug Pricing Program is critical for maintaining program compliance, especially given the increased attention to oversight in the 340B industry.

The intent of the 340B Drug Pricing Program is to permit covered entities “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The guiding principles for maintaining program integrity are to maximize oversight reach and manage compliance risk, and the strategies for meeting these are initial certification, annual recertification, program audits, and site visits.

In a session held at the 2015 American Pharmacists Association (APhA) annual meeting, Michelle Herzog, of the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs, and her 3 co-presenters outlined changes to the 340B Program in 2014, and those expected in 2015.

To help pharmacists keep up with these changes, Herzog answered the following questions via e-mail with Pharmacy Times:

What important changes are being made to the 340B Program?

• In 2015, data integration with other Federal systems (US Centers for Disease Control and Prevention, Office of Population Affairs) will be evaluated and potentially used to improve efficiencies.

• In terms of annual recertification, in 2014, 25,478 providers were certified, and 800 terminated. In the first quarter of 2015, more than 11,000 were recertified, and 314 terminated. In the second quarter, Title X will be added. In the third quarter, hospitals will be added.

• Questions have been added to site visits for Bureau of Primary Health Care grantees. Ryan White grantees will be added at a later date.

What do health-system pharmacists need to know about HRSA audits?

• All covered entity types are considered for risk-based audit selection.

• Risk-based factors are length in program, number of outpatient facilities, number of contract pharmacies, complexity of program, and volume of purchase.

• Targeted audits focus on a specific allegation.

• Audits are conducted by HRSA regional staff.

• A 1-page document on the audit process is available at www.hrsa.gov/opa.

How do pharmacists know when to self-disclose to HRSA?

At the time of initial registration and during the annual covered-entity recertification process, the covered entity’s authorizing official attests to the fact that “the covered entity acknowledges its responsibility to contact HRSA as soon as reasonably possible if there is any ... material breach by the covered entity of any of the foregoing [points of 340B compliance].” We are working to standardize the self-disclosure process, and highlight best practices to assist covered entities in this effort. Our goal is to increase program transparency while ensuring that supporting processes are efficient and effective for all stakeholders.

What do health-system pharmacists need to know about the peer-to-peer program?

• The program showcases high-performing 340B entities to provide practical examples of excellence in 340B integrity and quality.

• It serves as a resource for other entities wishing to raise the standard of their 340B practices.

• All 340B entity types are encouraged to apply.

• Qualified applications are evaluated on a rolling basis (limited spots are available).

• Applicants will be evaluated on 5 key areas:

1. 340B Program integrity

2. Providing access to affordable medications

3. Efficient business practices

4. Outcomes-driven clinical programs

5. Quality assurance programs

• Selected sites receive a stipend and other benefits, such as off-site training, APhA membership, and access to 340B events.

• To apply, go to www.hrsa.gov/opa, click on the “340B Peer-to-Peer” link on the left side of the screen, and click “Apply now” at the bottom of the page to complete the application.

How do savings afforded by the program translate into access to care?

While the law does not specify how 340B Program savings must be used, covered entities have indicated that they use the savings to provide more care to more patients and provide medications to those who may not otherwise be able to afford them. A 2011 Government Accountability Office study confirmed this self-reported data. It found that entities participating in the 340B Program are able to expand the type and volume of care they provide to the most vulnerable patient populations as a result of access to these lower-cost medications.

What else should health-system pharmacists know about the 340B Program?

Through HRSA’s expanding program integrity efforts, the 340B Program will continue to serve its integral role in our country’s health care safety net while remaining accountable to all parties involved. 340B is a tremendous benefit to the safety net and its patients, and we expect those that participate in the program and benefit from its savings to be compliant programs as required by the statute.