Health Article: Stark Phase II Final Rule - Summary and Analysis
4/14/2004
On March 26, 2004, the Department of Health and Human Services ("HHS") Center for Medicare & Medicaid Services ("CMS") released the long-awaited second phase of the final regulation (the "Final Rule") for the physician self-referral statute known as the "Stark Law."
The Stark Law prohibits a physician from referring a Medicare or Medicaid patient to an entity for certain "designated health services" ("DHS") if the physician (or an immediate family member) has a financial relationship with the entity unless the financial relationship falls completely within one of several exceptions.
This Summary and Analysis discusses various sections of the rule thematically and devotes separate sections to the important exceptions. The content is organized as below.
- Highlights of Phase II
- Comments and Changes to General Prohibition and Key Statutory Terms From Phase I
- Comments and Changes to Phase I Definitions of Designated Health Services
- Comments and Changes to Phase I Indirect Compensation Definition and Exception
- Comments and Changes to Phase I Exceptions Related to Physician Compensation
- Comments and Changes to Phase I Definition of Group Practice and In-Office Ancillary Services Exception
- Comments and Changes to Phase I Managed Care Prepaid Plans and Risk-Sharing Exceptions
- Comments and Changes to Phase I Exception for Academic Medical Centers
- Comments and Changes to Phase I Exceptions Related to Both Ownership and Compensation, Including New Phase II Exception
- Ownership and Investment Interest Exceptions (Phase II)
Statutory Compensation Exceptions (Phase II) - Comments and Changes to Phase I Compensations Exceptions, Including New Phase II Regulatory Compensation Exceptions
- Reporting Requirements and Sanctions (Phase II)
- Differences Between the Stark Law and the Federal Ant-Kickback Statute
The article is authored by Mintz Levin attorneys Thomas S. Crane, Hope S. Foster, Ellen L. Janos, Theresa C. Carnegie, Io C Cyrus, Karen S. Lovitch, Sarah L. Whipple, and Jennifer E. Williams, with assistance from and Ethan C. Eddy, who is in his third year of the JD/Masters in Public Health concurrent degree program at Northeastern University School of Law and Tufts University School of Medicine and is a full time intern with the law firm for the spring semester.
This article appeared in the Health Care Fraud Report, Vol. 08, No. 08, April 14, 2004, and is re-published here with the publication's permission.
