Lidia Rodriguez-Hupp, 340B Compliance Officer & Senior Vice President at Sentry and well-respected 340B thought leader, offered her views on what she considered the most provocative topics addressed at the 20th Annual 340B Coalition Conference last month. For Rodriguez-Hupp, the biggest announcement came when Office of Pharmacy Affairs (OPA) Captain Krista Pedley updated attendees on the agency’s plans to finalize the proposed mega-guidance.
Prior to the conference, HRSA said to expect final guidance in December. However, rumors were circulating that the Health Resources and Services Administration (HRSA)’s 340B Program Omnibus Guidance, commonly referred to as the “mega-guidance,” would be pushed off indefinitely or wouldn’t be issued in a final form at all. Even during Capitol Hill visits, many staffers indicated a likelihood that nothing would be final this year. Captain Pedley put all that to rest when she announced HRSA would, in fact, release the mega-guidance in December 2016.
“If the mega-guidance is issued in its entirety, covered entities that currently do not use a technology solution will have a hard time adhering to it without the ability to pinpoint and analyze some of the data required for compliance,” said Rodriguez-Hupp. “For instance, it would be difficult for a covered entity without a technology solution to tell that a prescription written post-discharge was based upon an outpatient encounter – and these are the only prescriptions that can be filled on a retail level under 340B as stipulated in the mega-guidance”
“Consider a person who visits the ER and is then discharged from there,” Rodriguez-Hupp continued. “It wouldn’t be hard to know where the patient’s prescription came from, but if that same patient gets sent to an inpatient floor, say cardiology, for observation, and is admitted and then discharged, that person isn’t eligible. If we consider yet another scenario in which the patient goes back down to observation from the cath lab and is then discharged, it’s considered an outpatient service, so the prescription becomes eligible.”
A topic from the conference that should have raised concern and that Rodriguez-Hupp feels many failed to pick up on, is that according to Pedley, OPA will take over direct management of 340B audits from HRSA beginning with the next fiscal year on Oct. 1. “Current HRSA audits are performed by HHS field staff – accountants and other groups of individuals with whom organizations have become familiar over the last couple of years, and individuals who have become very familiar with the nuances of 340B,” Rodriguez-Hupp noted. “What we have learned is that this task will be completed by a federal government contractor currently under selection by HRSA.”
Pedley acknowledges that although the details are still being worked out, the entities involved should see no change to their current processes. Rodriguez-Hupp replied, “HRSA has said this change won’t mean anything to hospital end users, but I run a team that has been onsite to support our customers in more than 100 audits, and I can tell you this will be a big change. It’ll be like it was back when audits first started.”
The conference also highlighted specialty pharmacies, increasing drug prices and the increased efforts of covered entities to improve patient care through combating prescription drug abuse. The event concluded with a focused discussion on how different states handle 340B and Medicaid Managed Care (MMC) to avoid duplicate discounts. Just a month earlier, on June 8th, the HHS Office of Inspector General released a report that said the Centers for Medicare & Medicaid Services should require states to change the way they identify 340B program drugs to avoid duplicate discounts in the Medicaid program (112 HCDR, 6/10/16).
“The OIG provided a summary of their report and recommendations to improve the 340B program further by increasing transparency and clarifying program rules to avoid duplicate discounts,” explained Rodriguez-Hupp. “This is one area that could be easily addressed by states utilizing unique identifiers. Representing the state of Oregon, Rich Holsapple provided Oregon Medicaid’s best practices for other states to consider as they look to improve their processes in collaborating with all stakeholders to strengthen the intersection of the Medicaid rebate program and 340B. There are solutions to improve transparency.”
One thing’s for certain. Technology is absolutely essential for 340B tracking, but not all solutions deliver the same capabilities. Antiquated first- and second-generation billing solutions, often referred to as “split-billing,” were not typically built for 340B compliance, and are not capable of delivering the necessary requirements to maintain 340B program integrity. Newer solutions, powered by rules-based compliance engines, provide a significantly improved opportunity for regulatory compliance and compliant capture of 340B benefits.