340B Compliance Made Easy with Diplomat MFT

by | Sep 27, 2021

The value and utility of managed file transfer software is everywhere, if you know what to look for. And when we find such cases, they serve as useful illustrations of how trusting a vital, repetitive business process to a secure, automated platform like our Diplomat MFT software works.

One such case is the 340B drug pricing program that was adopted by the U.S. federal government in 1992 under the purview of the Health Resources & Services Administration (HRSA). The government spends a lot of money on medicines through programs like Medicare and Medicaid, and 340B was created to help control those costs and keep prices low for individuals in those programs.

New Life for an Old Regulation
Because of the pandemic and the large sums of money being spent in response to the public health crisis, 340B compliance is a regulation that has taken on renewed interest for healthcare organizations and drug manufacturers. In May of this year, HRSA sent letters to six pharmaceutical companies notifying them that they were found to be out of compliance with 340B. It seems that in the chaos surrounding COVID-19 mistakes were made. But regulations exist for a reason, and compliance is necessary to ensure a program’s goals are met. When we learned of this, however, it turns out there is a lot more to 340B than simply mandating that drug makers keep prices low for patients enrolled in federal insurance programs.

Eligibility and compliance with 340B is a complicated matter, as you might guess. There’s a 43-page handbook on 340B compliance, in fact. Simply put, organizations that want to (or have to) participate in the program are required to provide documentation to the HRSA’s Office of Pharmacy Affairs of all related transactions. For example, if you are the administrator of a critical access hospital, pharmacy, Federally Qualified Health Center (FQHC), or other affected health care provider delivering medical services to rural or underserved communities, and many of your patients are enrolled in Medicare or Medicaid, you must file paperwork on a regular basis as your part in tracking the information and keeping everyone honest.

Complexities and Compliance
Often, due to the complexities of 340B compliance, there is a third-party 340B program administrator sitting between the health services provider and the HRSA. 340B program administration services provide specific expertise to manage the paperwork and minimize the risk of compliance failures. Due to the nature of the data being shared, the medical privacy regulation HIPAA-HITECH is in play, and so these 340B program management organizations use SFTP as a secure, HIPAA-compliant mechanism to send files between their customers and HRSA.

For organizations already operating on tight budgets, and where everyone from the CEO to the receptionist is expected to wear many hats in order to meet the health needs of the community as well as the administrative needs of the many state and federal agencies that are involved, it can get hectic. Under those conditions, mistakes are common. People are being pulled in different directions and doing the best they can, but something goes wrong and a deadline is missed or a step in the process is overlooked. That’s where Diplomat MFT comes into play. Diplomat MFT uses SFTP and PGP encryption to secure files in transit, creates an audit trail of all file transfers to prove compliance, and uses business process automation to ensure all steps required to collect and transfer data are done as prescribed.

Business process automation is a good way to reduce the risk of human error and remain compliant with programs like 340B. Rather than ask someone to assemble all the files required, encrypt them, prepare them for transfer, document the process, and confirm that everything happened on time, you can program a managed file transfer platform like Diplomat MFT to do it automatically, on whatever schedule is required. Then, even if someone is sick, new to the job and not yet trained, or just having a bad day, you can have confidence that your 340B filings are taken care of.

Rely on a Proven Platform
And Diplomat MFT can also handle sending insurance processing paperwork and whatever other sensitive files that need to be sent safely and reliably to a government agency, business partner, or other link in your administrative supply chain.

If you are a healthcare organization worried about the constant and increasing burden of sensitive data transfers that are required for all of the health, financial, and administrative regulations that exist today, or if you are a 340B program administrator looking for a secure, reliable, and cost-efficient platform for managing all the sensitive file transfers between your clients and HRSA, give Coviant Software a call. We can help you establish a simple, low-cost, secure, and reliable process to automatically take care of those critical data transfers.

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