“Five years ago, as the result of an accrediting survey, we found there was a lack of primary source verification for some of our employees,” said a pharmacy director for a large health system in the South Atlantic region. “At that time, for accreditation, we relied on a teammate who captured information with a homegrown system, paper, and computer spreadsheets.”
Nearly every healthcare CFO whose organization participates in the 340B Drug Pricing Program is familiar with (and understands) the risks associated with non-compliance. What most misunderstand is the severity of the cost of non-compliance. For example, the U.S. Health Resources & Services Administration requires 340B Program participants to ensure pharmaceutical makers aren’t giving duplicate discounts on drugs provided to 340B covered entities. If a 340B covered entity unwittingly submitted such claims the organization would have to pay back, potentially, millions of dollars to the drug maker. A penalty hurts for two reasons: 1) the possible size of the repayment, especially since most covered entities run on a thin profit margin, hovering around three percent, and 2) the time lapse between the claim error and discount repayments (i.e., the covered entity has generally closed its books… Read More »Do you have real-time situational awareness of 340B financial risks?
Whether you’re a veteran 340B Program manager or entering the field, the 340B landscape is complex and constantly changing. Keeping up with new requirements, regulations, and technology is one part of the job. Accounting for the status of an organization’s level of compliance is another piece. But monitoring 340B compliance status should not be a manual process. If that’s happening, 340B Program managers can fall behind on what really matters–directing their team, spotting risks, and finding opportunities for the program. Sectyr’s SectyrHub 340B software serves as the “air traffic control” for a 340B compliance program. With ever-changing 340B Program requirements, a 340B Program team can be overwhelmed by handling paperwork and records to maintain compliance. Increased scrutiny of the 340B Program by media, Congress, and drug makers only makes keeping up with requests and, potentially,… Read More »How to take the complexity out of 340B Program compliance
When asked what’s top of mind for a 340B Drug Pricing program manager, she said, “Knowing if I’m compliant today and if I would survive a HRSA audit without issue if that occurred next week.” The program manager went on to say that “Maintaining and protecting our 340B benefit is extremely important to our profitability.” Maintaining compliance every day and guarding profitability takes a complex balance of foresight and fortitude. Navigating the requirements requires equal parts insight and resources. To help bring that insight, we’re launching a 10-part blog series today that aims to examine not only the challenges to complying with the 340B Program but also strategies and tactics for making it easier to do so. Continually complying with the U.S. Health Resources and Services Administration requirements is a linchpin for avoiding the financial… Read More »The 340B Program problem: Achieving around-the-clock compliance
To say the link between Medicaid and 340B is complicated would be an understatement. By federal law, a covered entity’s 340B program and Medicaid program get discounted drugs for patients with Medicaid, but only one entity can legally receive the discounted drug. This leads to, among other things, administrative stress because covered entities must ensure drug makers aren’t charged two discounts for one drug, otherwise known as duplicate discounts. Everyone from physicians to lawmakers seem to be weighing in on this issue. In December 2022, Pennsylvania distributed a medical assistance bulletin effective Jan. 1, 2023, that seems to indicate the commonwealth will no longer offer Medicaid reimbursements for 340B drugs dispensed by contract pharmacies. Specifically, the bulletin states, “The MA [medical assistance] Program is unable to identify 340B-purchased drugs dispensed by contract pharmacies, therefore, contract… Read More »Tackling 340B Duplicate Discounts
For pharmacists, pharmacy technicians, and other staff, a clock is counting down to November 1, 2023, and revisions to USP 797. That’s the date by which the United States Pharmacopeia Convention, or USP, has set for implementing changes to USP Chapter 797. USP 797 outlines requirements and procedures for compounding sterile drugs – among the riskiest duties undertaken by pharmacists on behalf of their patients. The convention first put in place USP 797 on January 1, 2004. The chapter sets forth a standard of practice for pharmacists. And the authors originally wrote this section to “prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.” Industry pundits say there are mixed feelings among pharmacy professionals for the latest revisions.… Read More »Pharmacies prepare for revisions to USP 797
Last spring, the American Society of Health-System Pharmacists released findings from a survey that noted a severe shortage of pharmacy technicians. While healthcare shortages are well publicized, the extent to which administrators are tapping pharmacists to help is noteworthy. Ninety percent of hospital and health-system pharmacy administrators said they had asked pharmacists to perform tasks usually handled by technicians. With a lack of technicians, pharmacists and other team members must juggle additional roles and/or work longer hours. Technology can play a role in helping time-strapped pharmacies automate the management of accreditations and document compliance activities like adhering to USP 797 and USP 800. Pharmacy administrators owe it to themselves to consider which technologies could shoulder some of the work to help pharmacists, staff, and patients. Younger generations rethinking primary care Hospitals and health-system pharmacies aren’t… Read More »Tapping the right technology frees time-strapped pharmacists to focus on healthcare
Sectyr, a leader in SaaS based compliance software for healthcare, has been named to Inc. magazine’s annual Best Workplaces list. Featured in the May/June 2022 issue, hitting newsstands on May 17, 2022, and prominently featured on Inc.com, the list results from a comprehensive measurement of American companies that have excelled in creating exceptional workplaces and company culture, whether operating in a physical or virtual facility.
The move will result in an expansion of the SectyrHub® compliance platform bringing expanded functionality to customers and furthering the company’s mission of helping customers achieve Continuous Program Compliance®.
At the recommendation of a leading 340B consulting firm, Fatimah investigated SectyrHub 340B compliance software and moved forward with implementing the tool in 2018. Saint Peter’s recognized how the solution provided oversight and organization for their complex program and appreciated how it addressed 340B-specific elements with guided workflows.