Becker's Spine Review

42 PRACTICE MANAGEMENT Stark Law under the spotlight as CMS seeks to ease self-referral regulatory burden, MedPAC cracks down on PODs By Laura Dyrda C hanges could be coming to Stark Law. On June 20, CMS began seeking input on reducing the regulatory burden of Stark Law to allow for more care coordination between organizations. e June 2018 Med- PAC report also addressed potential Stark Law changes, focused on tightening the lan- guage to prohibit physician self-referral asso- ciated with physician-owned distributorships. e MedPAC report suggests revising Stark Law to eliminate the "per unit of service" rule for PODs and making PODs an entity of the Department of Human Services. Under this change, physicians would not be able to re- fer patients to PODs they had ownership in, with few exceptions. MedPAC also aims to have PODs identified as PODs in the Open Payments reporting program, which requires companies to disclose provider payments. "e goal of any change to the Stark Law would not be to ban PODs per se, but rather to prohibit physician self-referral involving PODs," the report states. But when it comes to self-referral related to care collaboration, CMS is seeking ideas to reduce the regulatory burden and allow pro- viders to collaborate more closely. e agency solicited comments about areas of high reg- ulatory burden, and more than 2,600 com- ments mentioned Stark Law compliance as one of those areas. CMS reviewed existing regulations and in coordination with HHS Deputy Secretary Eric Hargan, the agency is collecting input to better understand and ad- dress provider concerns about Stark Law. "Removing unnecessary government obsta- cles to care coordination is a key priority for this administration," said Mr. Hargan. "We need to change the healthcare system so that it puts value and results at the forefront of care, and coordinated care plays a vital role in this transformation." In particular, CMS is looking for input on structuring arrangements between parties that participate in alternative payment mod- els and other new financial arrangements to revise Stark Law or add as an exception. e public comment period runs through Aug. 24, 2018. "We are looking for information and bold ideas on how to change the existing regu- lations to reduce provider burden and put patients in the driver's seat," said CMS Ad- ministrator Seema Verma. "Dealing with the burden of the physician self-referral law is one of our top priorities as we move towards a healthcare system that pays for value rather than volume." n 2 orthopedic practices under HHS investigations for recent security breaches By Mackenzie Garrity H HS is currently investigating cybersecuri- ty breaches at two orthopedic clinics that occurred in June and July. Port Charlotte, Fla.-based Advanced Orthopedic Center was hit with a hacking and information technology incident in July. HHS believes the cybersecurity breach affected the orthopedic group's network server. AOC has two locations in Florida. It is estimated more than 1,600 individuals may have been af- fected by the security breach. Metropolis, Ill.-based Orthopaedic Institute Sur- gery Center faced a hacking and IT incident back in June. The security breach affected emails. The HHS investigation also determined 2,000 individuals may have been affected from the email breach. n Crystal Clinic faces backlash from residents over $100M clinic proposal: 4 takeaways By Mackenzie Garrity R esidents in Akron, Ohio, are taking legal action after city officials approved a Cleveland-based Crystal Clinic project to build a $100 million clinic, according to the Akron Beacon Journal. Here are four takeaways: 1. Some Akron residents are upset over the traffic, noise and pol- lution potential from the new clinic. They filed an appeal with the Summit County Pleas Court in Akron over the city's approval of a conditional use permit for the project; the complaint, however, did not include a specific reason for the appeal. 2. Crystal Clinic plans to develop a 60-bed hospital for orthopedic and plastic surgery. The new hospital is expected to be one of the tallest buildings in the city. 3. The Akron Planning Commission approved Crystal Clinic's plans May 10. It is uncommon for residents to file appeals over a Planning Com- mission decision, according to Fairlawn Law Director R. Bryan Nace. 4. The new hospital is expected to open in mid-2020. n

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