While hundreds of U.S. hospitals are implementing Ebola training requirements and new patient screening protocols, some are going a step further. One facility recently announced that it will place any employee on paid leave who has “in the last month returned to the U.S. from Guinea, Liberia, Sierra Leone, Nigeria and Senegal.” Other facilities are requesting its vendors refrain from sending representatives for 21 days if they traveled to the regions of West Africa within the last month.
The other day, a new Compliance Officer asked the question, “How would you go about conducting a physician leasing audit, and if you realize there are issues, where should you start fixing them?” That was a huge question! How and where to begin are the questions every new hospital Compliance Officer faces. How do you fix a compliance problem? The answer is, “one bit at a time.” First, we must review the hospital’s policy and procedure on Space Lease and also on Equipment Leases. This is typically in the legal department (ideally, all policies and procedures will be maintained in one accessible location). Make sure the policy and the procedures are written to comply with most recent Stark Law Space and Equipment lease exception:
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At the Health Connect Partners (HCP) Hospital and Healthcare I.T. Conference meeting, we discussed Contracting with Physician-owned Entities and how your compliance program can implement safeguards to ensure that you don’t run afoul of the Anti-Kickback Statue (AKS) and Stark Laws. The Office of Inspector General (OIG) announced that it has moved to evaluating compliance program effectiveness during investigations. So it isn’t enough to have the appropriate policies and procedures in place. Instead we must continually monitor and evaluate the effectiveness of our processes. The Government looks at a number of factors when evaluating agreements with physician-owned companies.
How can we know very little about a patient being treated for Ebola at Emory University in Atlanta, while reporting the details of the patient who died from the disease in Dallas? According to Michelle De Moody, Deputy Director for Consumer Privacy at the Center for Democracy and Technology, covered entities can let individuals know if they have been exposed to the disease through contact or shared space with an infected person.
So your legal department has a process for contracting with physicians or referral sources. Where do you fit in the process?
Last week at the Health Connect Partners (HCP) Hospital and Healthcare I.T. Conference in Chicago, we discussed common contracting issues faced by hospital Directors of Materials Management. Materials Management professionals are central to the contracting process and are extremely vigilant about the laws imposed. The Office of Inspector General (OIG) has warned against substantial fraud and abuse issues with Physician-Owned Entities and Hospitals under the federal Anti-Kickback Statue (AKS) and Stark Laws. AKS makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, referrals of items or services reimbursable by a Federal healthcare program. The Stark Law is a civil statute that prohibits physicians from referring Medicare patients for certain designated health services (DHS) to an entity with which the physician has a financial relationship, unless an exception applies. The OIG considers arrangements with Physician-owned entities inherently suspect because the opportunity for a referring physician to earn a profit from the sale or use of a device could be violate AKS and Stark depending upon the intent and the structure of the deal.