Issue link: https://beckershealthcare.uberflip.com/i/790284
47 CFO / FINANCE Trump Administration Withdraws 340B Mega-Guidance: 6 Things to Know By Ayla Ellison T he Trump administration withdrew guidance Jan. 30 on the 340B Drug Pricing Program that was under review at the end of the Obama administration. Here are six things to know about the guidance. 1. HHS' Health Resources and Services Administration released the omnibus guidance on the 340B Drug Pricing Program in August 2015. e 340B Drug Pricing Program allows certain safety-net healthcare organizations to purchase outpatient drugs at discounted prices. 2. e guidance addressed a broad range of topics within the 340B pro- gram, including the definition of patient, contract pharmacy compli- ance requirements, hospital eligibility criteria and eligibility of off-site outpatient locations. 3. On Jan. 30, the White House Office of Management and Budget marked the final guidance document as withdrawn. 4. Although the pharmaceutical drug industry generally supported the guidance, hospitals raised concerns about the proposal. e American Hospital Association previously expressed concern about the guid- ance, arguing that redefining patient eligibility for the 340B program would have inappropriately narrowed the number of drugs that qualify for 340B pricing. 5. On Feb. 1, AHA Executive Vice President Tom Nickels said, "We are pleased that the administration chose not to finalize the Health Resources and Services Administration's guidance, which, if enacted, would have jeopardized hospitals' ability to service vulnerable popu- lations, including low-income and uninsured individuals and patients receiving cancer treatments." 6. For HRSA's guidance to move forward, it would have to be resubmit- ted to the Office of Management and Budget. n Tenet Indictment Signals New Era of Healthcare Fraud Investigations By Ayla Ellison D allas-based Tenet Healthcare agreed to pay approx- imately $514 million last October to resolve allega- tions the company paid kickbacks in exchange for patient referrals. Although Tenet settled the lawsuit, the federal government attached a name to the case when a former Tenet executive was charged for his alleged involve- ment in the scheme. In an indictment filed Jan. 24, John Holland, who previ- ously served as senior vice president of operations for Tenet's Southern States Region and as CEO of North Fulton Medical Center in Roswell, Ga., was charged with one count of healthcare fraud and two counts of major fraud against the United States. According to the Department of Justice, Mr. Holland and his co-conspirators circumvented Tenet's internal account- ing controls to pay illegal kickbacks and bribes to a clinic that referred undocumented pregnant patients to Tenet hospitals for Medicaid-covered deliveries. Federal prosecu- tors allege the illegal scheme helped Tenet bill the Georgia and South Carolina Medicaid programs for more than $400 million. The case against Mr. Holland, who has pleaded not guilty to the charges, highlights the government's interest in hold- ing individuals — not just the organizations they work for — responsible for fraud. Traditionally, healthcare companies were only expected to provide information about the underlying factual situation in a fraud investigation. However, these investigations have become more complicated, as the DOJ has taken a strong stance on pursuing healthcare executives involved in fraud cases to hold them personally responsible. In a memo issued to federal prosecutors in September 2015, the DOJ provided guidance on steps it is taking to strengthen its pursuit of individual corporate wrongdoing. The repercussions of the memo — which has been dubbed the "Yates memo" after former Deputy Attorney General Sally Yates — are significant. One key change is that to be el- igible for any cooperation credit, companies must provide the names of individuals involved in the fraud, no matter where they sit within the company. Although it has been more than a year since the Yates memo was distributed, Linda Baumann, a partner with Arent Fox, told Bloomberg BNA there has been a recent increase in the number of healthcare fraud prosecutions against individu- als. Ms. Baumann attributed the pause between the Yates memo and the ramp-up in individual fraud prosecutions to the time it takes to develop cases against those involved in healthcare fraud. She also said the recent increase may be due to the federal government's desire to finish investiga- tions before the administration changed. n