By Linda Rouse O’Neill
HIDA supported language included in Federal Spending Bill
You may have read back in December that the U.S. Congress passed a $1.1 trillion omnibus spending bill to fund nearly all of the federal government through September 30. Not reported as heavily, yet carrying significant implications for long-term care customers and patients, is a provision requiring the Centers for Medicare and Medicaid Services (CMS) to conduct a study within 90 days to measure Medicare’s Competitive Bidding program’s impact on enteral patients in skilled nursing facilities (SNFs), nursing homes, and intermediate care facilities.
Specifically, CMS will look at how the Competitive Bidding program has affected patient treatment, including impacts on patient health, whether product access has been reduced, and if costs have increased due to new suppliers unfamiliar with the clinical demands associated with enteral care. For years, HIDA has advocated these settings and enteral nutrition formulas and supplies are not well suited for competitive bidding, and it appears our message has been heard. The requested study reflects these concerns and is a noteworthy win for the extended care market.
Also worth mentioning: the bill includes $5.4 billion to help the government fight the recent Ebola crisis, while also allowing the U.S. to prepare for and respond to future infectious disease outbreaks. HIDA and our members worked directly with the Department of Health and Human Services (HHS) as well as other stakeholder organizations over the past several months to coordinate the supply chain response. HIDA continues to communicate regularly with HHS as the industry works on lessons learned and how to improve response and coordination efforts moving forward. HIDA also monitors and collects personal protective equipment guidance and news of interest for distributors via our Ebola Resource Center.
FDA bends on traceability enforcement
Pharmaceutical manufacturers, wholesalers, and repackagers must comply with national prescription drug traceability requirements effective January 1, outlined in Phase 1 of the Drug Quality and Security Act (DQSA). Since our last update on key DQSA topics and questions to discuss with your customers, however, the Food and Drug Administration (FDA) announced its intention to exercise discretion when enforcing certain aspects of the track and trace law until May 1, 2015.
What this means is that the FDA has essentially given manufacturers, repackagers, and wholesale distributors a four-month grace period to comply with the DQSA’s new Transaction Information, Transaction History, and Transaction Statement (TI/TH/TS) requirements. The FDA does not intend to take enforcement action against trading partners that fail to provide or capture product tracing information, but the agency still reserves the right to enforce the law for egregious offenders.
Overall, this is welcome news for pharmaceutical trading partners still refining TI/TH/TS systems or transitioning processes to online formats. Regardless, this underscores the short window of time organizations have to become compliant with the DQSA before facing possible penalties.
As always, if you or your customers have additional questions about the DQSA, Ebola, or Medicare’s Competitive Bidding program, please contact us at HIDAGovAffairs@HIDA.org.