Major Changes to Stark Law in 2009 IPPS Regulations
August 2008

Set forth below are the statutes, regulations, and other documentation regarding Medicare and Medicaid fraud and abuse. Information includes the Stark anti-referral requirements and general anti-kickback information.

CMS's Disclosure of Financial Relationships Report
Information and resources the mandatory survey to 500 hospitals on their financial relationships with physicians

The Stark Anti-Referral Laws and Regulations

The Stark Statute 42 U.S.C. 1395nn

Phase II of the Stark II regulations as published in the Federal Register on March 26, 2004. The regulations constitute final rules and became effective on July 26, 2004.
Regulations as published in the Federal Register March 26, 2004
Bricker & Eckler Bulletin on the Phase II Regulations

Phase III of the Stark II regulations as published in the Federal Register on September 5, 2007. The regulations constitute final rules and became effective on December 4, 2007.
Regulations as published in the Federal Register September 5, 2007
Bricker & Eckler Bulletin on the Phase III Regulations

The regulations section by section, including the Phase III amendments
Note that these sections include changes from the 2009 Inpatient Prospective Payment Final Rules published in Federal Register August 18, 2008

• 411.350 Scope
• 411.351 Definitions
• 411.352 Group Practice
• 411.353 Prohibition on Certain Referrals by Physicians and Limitations on Billing
• 411.354 Financial Relationship, Compensation, and Ownership or Investment Interest
• 411.355 General Exceptions to Referral Prohibitions Related to Both Ownership/Investment and Compensation
• 411.356 Exceptions to Referral Prohibitions Related to Ownership or Investment Interests
• 411.357 Exceptions to Referral Prohibitions Related to Compensation Arrangements
• 411.361 Reporting Requirements

Comparison Chart of Stark Exceptions and Anti-Kickback Safe Harbors
Includes the Phase III revisions, effective December 4, 2007
They also include changes from the 2009 Inpatient Prospective Payment Final Rules published in Federal Register August 18, 2008

CMS Clarifies Lithotripsy “Under Arrangements” Contracts: Can Continue to Use Per-Click and Percentage-Based Payments
February 2009
The Centers for Medicare and Medicaid Services has issued a clarification of the Stark law and hospital "under arrangements" contracts for lithotripsy services.

Major Stark Law Changes in the 2009 Medicare IPPS Regulations
August 2008
Bulletin discussing significant changes to the Stark law as contained in the 2009 inpatient prospective payment system regulations.

Anti-Kickback Statutes and Regulations

The Anti-Kickback Statute 42 U.S.C. 1320a-7b

The Anti-Kickback Safe Harbors
Federal regulations at 42 C.F.R. 1001.952

Anti-Kickback Safe Harbors for Electronic Prescribing and Health Records
Effective October 7, 2006

Fraud Alerts and Advisory Opinions
As prepared by the HHS Office of Inspector General

OIG Advisory Opinion 06-22
Approval of Limited Gainsharing Arrangement (November 2006)

OIG Advisory Opinion 05-04
Approval of Limited Gainsharing Arrangement (February 2005)

OIG Advisory Opinion 05-03
Approval of Limited Gainsharing Arrangement (February 2005)

OIG Advisory Opinion 05-02
Approval of Limited Gainsharing Arrangement (February 2005)

OIG Advisory Opinion 05-01
Approval of Limited Gainsharing Arrangement (January 2005)
   Bricker & Eckler Bulletin on the Gainsharing Advisory Opinion

Hospital Discounts Offered to Patients Who Cannot Afford to Pay Their Hospital Bills
OIG Bulletin (February 2004)

Special Advisory Bulletin on Offering Gifts and Other Inducements to Beneficiaries
OIG special advisory bulletin published in the Federal Register on August 30, 2002 dealing with the offering of gifts and other inducements to Medicare beneficiaries.

Frequently Asked Questions Related to OIG Corporate Integrity Agreements
As prepared by the HHS Office of Inspector General