The Future of 340B in 2016

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Considering that policies and procedures are ever-changing within our industry, it is crucial that experts like those at PBIRx have staff dedicated to industry changes bringing opportunities to their clients on a continuum. Continuing to place our focus on the 340B Drug Pricing Program, the latest news and updates suggest that 2016 is going to be quite a year, with changes and new initiatives on the way. Below, we want to share a few key points that we have compiled through our research on predictions about 340B for this year:

1. In September of 2016, it is expected that HRSA will publish their final 340B Program “mega-guidance.” For those of you who are unaware, their first “mega-guidance” was published in August of 2015, however, concerns and a federal court decision led to the need for a second edition.
2. New rules regarding monetary penalties for drug manufacturers that overcharge covered entities under the 340B program, such as hospitals, will be put into place. These rules are expected to be brought into the public eye in May of 2016.
3. Also in May of 2016, we can expect to see HRSA propose a new rule surrounding the 340B Program’s administrative dispute resolution process. It is said that this proposal will apply to both the drug manufacturers and covered entities.

In addition to the above, our research also states that the HHS Office of Inspector General (OIG) also has plans for this year that involve the 340B Program. One plan of action is to take a look at Medicaid managed care organizations that pay for drugs purchased through the program and determine the risk of duplicate discounts for them. An explanation on the efforts that will be taken to prevent this is also said to be on the horizon.

To learn more about the expected future for 340B in 2016, check out the full article from Health Care Law Today here. 

At PBIRx, we are heavily involved with the 340B Program and offer our own independent compliance audits along with ongoing management, which include monthly compliance audits and updates to Policies and Procedures documents.    These services ensure that our clients will maintain their 340B status. For more information about this service, as well as our participation with the program, please visit www.pbirx.com or call (888) 797-2479.

What Is The 340B Drug Pricing Program?

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

In the world of pharmacy benefits, there are a multitude of programs, policies and laws that must be completely understood by the parties involved. However, a particular program that must not be overlooked is the 340B Drug Pricing Program. Here at PBIRx, we recognize the significance and value of this program, which is why we have made it a priority to offer independent third party 340B compliance audits as one of our services. But, if you are unsure of what the 340B Drug Pricing Program is to begin with, then you may not be clear on how our services can help you. Below is summarized information on the 340B Drug Pricing Program:

340B Drug Pricing Program

Ultimately, the 340B Drug Pricing Program is a program that the United States federal government created in 1992 in order to ensure that certain discounts are offered to eligible healthcare organizations and covered entities. But before we can truly understand how and why the program was developed, it is important to briefly touch on the Medicaid Rebate Program, which was implemented by Congress two years prior in 1990.

The Medicaid Rebate Program was designed so that drug manufacturers had to “pay rebates to state Medicaid programs for covered outpatient drugs, as defined in the Medicaid rebate statute.” However, the American Action Forum explains that although this was enacted to reduce Medicaid costs, the results that followed eventually caused providers such as hospitals with low-income patients to absorb some of the remaining costs of providing drugs. Thus, the 340B program was implemented to make sure that those healthcare providers who serve low-income patients would also receive certain discounts. 340Bhealth.org explains that according to the Congressional report, the ultimate purpose of the program is to “enable covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive service.”

Who Is Eligible?

In order to be eligible to participate in the 340B Drug Pricing Program, covered entities must fall into one of the following categories:

1. Hospitals, including:

- Disproportionate Share Hospitals

- Children's Hospitals

- Cancer Hospitals

- Sole Community Hospitals

- Rural Referral Centers

- Critical Access Hospitals

2. Health Centers, including:

- Federally Qualified Health Centers and Federally Qualified Health Center Look-Alikes

- Native Hawaiian Health Centers

- Tribal/Urban Indian Health Centers

3. Ryan HIV/AIDS Program Grantees

4. Specialized Clinics, including:

- Black Lung Clinics

- Comprehensive Hemophilia Diagnostic Treatment Centers

- Title X Family Planning Clinics

- Sexually Transmitted Disease Clinics

Though, there are other qualifications that must be met - contact PBIRx for the specifics.

PBIRx’s Role in the 340B Program

Here at PBIRx, it is our goal to ensure that our eligible clients maintain their 340B status, which is why we provide on-site audits that not only prepare a covered entity for an actual HRSA audit, but also identify changes that must be made to be compliant with a HRSA audit. Our 340B dedicated staff of experts works diligently with each client to review their policies and procedures surrounding 340B medications, verify their internal controls meant to prevent diversion and duplicate discounts, and test any transactions that have to do with 340B medications. But that is certainly not all! We also review contract pharmacy data, offer quarterly compliance meetings, provide an ORA report, and offer information about the latest policy changes, depending on the client’s level of service.

For more information about the 340B Drug Pricing Program and the services PBIRx provides in all areas of the program, please visit us at www.pbirx.com or call (888) 797-2479 today.