Wisconsin Health Lawyer

Archive for the ‘Ambulatory Surgery Centers’ Category

By John Fisher, JD, CHC, CCEP

A Tennessee based ambulatory surgery center company has agreed to pay damages to a former employee who filed a suit alleging that physician investments in local surgery center entities violated the Anti-kickback Statute.  The case highlights some of the unique kickback issues that are present in ambulatory surgery center structure.  Specifically, the case demonstrates how investment terms that are intended to assure compliance with the safe harbor regulations under the Medicare Anti‑Kickback Statute (42 U.S.C. § 1320a-7b(a)-(b)) can create evidence of non-compliance if the initial terms of the offering relate, in whole or in part, to the volume or value of expected referrals from the investor in the ASC venture.

In order to comply with safe harbor requirements, ASCs must generally require investing physicians to use the facility as an extension of their medical practices.  However, if the terms of the investment are based on the volume or value of referrals, those same requirements become evidence that referrals are being required in exchange for remuneration.  In the Tennessee case, the ASC management company purchased controlling interests in local surgery center entities at a high multiple of earnings.  Physicians who were referral sources were offered investments at less than 1/3 of the

Read more here: Health Law Blog

By John Fisher, JD, CHC, CCEP

Expanding Physician Owned Hospitals – Stark Law Approval Process

The Stark Law prohibits physicians from owning interests or having financial relationships with entities that provide “designated health services,” including hospital services, unless an exception exists.  The Stark Law contained an exception that permitted investment in a “whole hospital” but that exception was seriously limited under the Affordable Care Act.  Physician-owned hospitals must now obtain CMS approval of any expansion projects.  CMS regulations define the process and requirements for obtaining CMS approval of expansion projects.

I posted an article on the Health Law Blog that summarizes some of the requirements for obtaining approval for expansion of a physician-owned hospital.

Read more here: Health Law Blog

CMS Regulations Would Eliminate Need For Staff Radiologist In ASC

Just a few days ago, CMS released a proposed regulation that contains a number of regulatory items that is considers to be unnecessary and overly burdensome on providers and in need of elimination.  One item that was proposed is the elimination of the requirement that Ambulatory Surgery Centers maintain a radiologist on staff.  This requirement makes little sense to most Ambulatory Surgery Centers because radiologic services are normally limited to services that are provided contemporaneous with a surgical service.  In these cases, the surgeon must be qualified to perform the procedure, including the use of the radiology component.

In most cases, having a Radiologist on staff at an Ambulatory Surgery Center is not necessary and in fact creates credentialing and other costs.  Arrangements with Radiologists also raise potential liability concerns for the Radiologist who has responsibility to review material that was not intended as part of a diagnosis but was rather only part of a procedure.  Many radiologists have become concerned about potential “line of site” issues that could be present and which they could be liable for by being responsible for oversight of radiology services at the Ambulatory Surgery Center.

Under the proposed regulations, ASCs would be limited to providing radiologic services that are integral to the procedures being performed at in the facility.  Surgeons would need to demonstrate competency in using radiology in the performance of the surgical procedure.  A general member of the Medical Staff could be put in charge of radiology oversight, thus reducing the expense involved with credentialing and compensating a radiologist to be on staff at the ASC.

This change was just proposed a few days ago as part of a series of rule changes aimed at cutting unnecessary regulatory burdens on providers.  There is currently no reason to believe that the change will not eventually be adopted in a final regulation.  Until final adoption of the regulation, Ambulatory Surgery Centers must continue to comply with current conditions of participation which include the necessity of having a radiologist on staff.

You can find the regulations at the following Link.  CMS ASC Radiology Rule