OIG issued Advisory Opinion 09-08 allowing Requestor–“a pharmaceutical and healthcare company that develops, manufactures, and markets pharmaceutical products–to develop a Program “that will make available at no charge certain of its drug products to indigent patients without prescription drug coverage.” The OIG determined that the Program falls under the umbrella of a Bulk Replacement Model, […]
OIG permitted joint venture of Ambulatory Surgery Center (ASC) by a hospital and LLC. In its Advisory Opinion 09-09 released yesterday, the Office of Inspector General (OIG) analyzed a situation in which a Hospital and an LLC (Surgeon LLC), owned by seven orthopedic surgeons (Surgeon Investors), would jointly own a company that will own and […]
This article is the second part of a 2 part series addressing recent federal regulatory action targeting diagnostic imaging arrangements. Part 1 (published in the January/February 2009 issue of Radiology Management) focused solely on some of the more significant changes to the federal Stark regulations. Part 2 will summarize some of the significant regulatory actions […]
In recent years, the diagnostic imaging services industry has been intensively scrutinized by the federal government, as evidenced by heightened regulatory action targeting certain diagnostic imaging arrangements, such as changes to the federal Stark Law (that restrict the flexibility of structuring diagnostic imaging arrangements), expansion of the federal anti-markup prohibition, changes to the independent diagnostic […]
Recent legislative initiatives to restrict (or eliminate) the Stark Law’s In-Office Ancillary Services Exception (IOASE) are by no means a new phenomenon. Rather, over the last few years, the Centers for Medicare and Medicaid Services (CMS) has introduced several significant proposals targeting the provision of diagnostic imaging (and other ancillary services) in the physician office […]
According to the 2010 Proposed Physician Fee Schedule (PPFS), as of January 1, 2012, the Center for Medicare and Medicaid Services (CMS) proposes that Medicare payment be made only for the technical component (TC) of advanced diagnostic imaging services to suppliers who have met the accreditation requirements set forth by the Secretary. According to CMs, […]
An Office of Inspector General (OIG) Advisory Opinion, OIG Advisory Opinion No. 09-06, was released addressing the issue of whether or not “expanding an existing program that provides free oral nutritional supplements to malnourished end-stage renal disease patients who are on dialysis” would violate the civil monetary penalty provision or the anti-kickback statute. The Requestor […]
An Office of Inspector General (OIG) Advisory Opinion, OIG Advisory Opinion No. 09-06, was released addressing the issue of whether or not “an existing arrangement in which a hospital has agreed to share with a cardiology group, a vascular surgical group, and an interventional radiology group a percentage of the hospital’s cost savings arising from […]
Doctors, say goodbye to your free vacations, mugs, and even pens you get from pharmaceutical companies. If you live in Massachusetts or Vermont, the state has passed regulations banning physicians from receiving gifts from pharmaceutical companies. In Vermont, getting a free meal is also banned while Massachusetts limits it. This regulation grows out of a […]
Health Law Partners Adrienne Dresevic and Carey F. Kalmowitz published an article in Link, the American Healthcare Radiology Administrators (AHRA) member newsletter, which discusses current application of the Federal Stark law. The article addresses the In-Office Ancillary Services Exception (IOASE), which many office-based diagnostic imaging arrangements rely upon to enable referring physicians to provide ancillary […]
Health Law Attorney Blog