Includes changes from the 2009 Inpatient …

1 Includes changes from the 2009 Inpatient Prospective Payment Final Rules published in federal Register August 18, 2008 and reference to changes made by the Patient protection and affordable Care Act of 2010. Index to Exceptions and Safe Harbors Academic Medical Centers -- 56 Ambulance Restocking -- 37 Ambulatory Surgery Centers -- 3 Charitable Donations by a Physician -- 64 Community-Wide Health Information Systems -- 65 Cooperative Hospital Service Organizations -- 7 Compliance Training -- 36 Discounts: Buyers Who Submit Claims and Sellers Thereto -- 9 Discounts: Buyers who Submit Cost Reports and Sellers Thereto -- 10 Electronic Health Records Items and Services -- 74 Electronic Prescribing Items and Services -- 72 Employment Relationships -- 11 EPO and Other Dialysis-Related Drugs Furnished in or by an ESRD Facility -- 55 Equipment Leases -- 18 Eyeglasses and Contact Lenses Following Cataract Surgery -- 54 Fair Market Value Compensation -- 12 Federally Qualified Health Centers -- 70 Group Practice Arrangements With a Hospital -- 13 Group Purchasing Organizations 14 Implants in an ASC -- 56 Increased Coverage, Reduced Cost-Sharing Amounts.

2 Or Reduced Premium Amounts Offered by Health Plans -- 43 Indirect Compensation Arrangements -- 36 In-Office Ancillary Services -- 60 Intra-Family Rural Referrals -- 69 Investment Interests -- 48 Investments in Group Practices -- 16 Isolated Transactions -- 18 Joint Ventures in Underserved Areas -- 18 Medical Staff Incidental Benefits -- 34 Non-Monetary Compensation Up to $300 -- 8 Obstetrical Malpractice Insurance Subsidies -- 44 Personal Services and Management Contracts -- 27 Physician Incentive Plans -- 15 Physician Services -- 43 Practitioner Recruitment -- 21 Preventive Screening Tests, Immunizations, and Vaccines -- 54 Price Reductions Offered by Contractors With Financial Risk to Managed Care Organizations -- 48 Price Reductions Offered to Eligible Managed Care Organizations -- 48 Price Reductions Offered to Health Plans -- 31 Professional Courtesy -- 64 Referral Agreements for Specialty Services -- 47 Referral Services -- 29 Retention Payments in Underserved Areas -- 66 Risk Sharing Agreements -- 35 Sale of Practice 28 Services Furnished by an Organization to Enrollees -- 59 Space Leases -- 20 Unrelated Remuneration -- 69 Waiver of Beneficiary Coinsurance and Deductible Amounts -- 25 Warranties -- 26 Ambulatory Surgery Centers: All Stark [No comparable exception.]

3 Ambulatory surgery centers exempt under Stark, not a designated health service] Anti-Kickback Safe harbor for payments on an investment interest in ASC The entity is a certified ambulatory surgery center (ASC) under the Medicare program. The operating and recovery room space is dedicated exclusively to the ASC. patients referred to the ASC by an investor are fully informed of the investor's investment interest in the ASC. The terms on which an investment interest is offered must not be related to previous or expected volume of referrals, services furnished, or the amount of business otherwise generated from the investor to the ASC. The ASC or any investor (or other individual or entity acting on behalf of the entity or any investor) must not loan funds to or guarantee a loan for an investor if the investor uses any part of such loan to obtain the investment interest.

4 The amount of payment to an investor in return for the investment must be directly proportional to the amount of the capital investment (including the fair market value of any pre-operational services rendered) of that investor. All ancillary services for federal or state health care program beneficiaries performed at the ASC must be directly and integrally related to primary procedures performed at the ASC, and none may be separately billed to a federal or state health care program. The ASC and any physician or surgeon or hospital investors must treat patients receiving medical benefits or assistance under any federal or state health care program in a nondiscriminatory manner. Ambulatory Surgery Centers: Hospital/Physician ASCs Stark [No comparable exception; ambulatory surgery centers exempt under Stark, not a designated health service] Anti-Kickback Safe harbor for payments on an investment interest in a hospital/physician ambulatory surgery center All requirements listed under "Ambulatory Surgery Centers: All" are met.

5 At least one investor is a hospital and all of the remaining investors are: a)(i) general surgeons or surgeons engaged in the same surgical specialty, who are in a position to refer patients directly to the ASC and perform surgery on such referred patients ; ii) physicians engaged in the same medical practice specialty who are in a position to refer patients directly to the ASC and perform procedures on such referred patients ; or iii) physicians who are in a position to refer patients directly to the ASC and perform procedures on such referred patients ; b) group practices composed of such physicians; c) surgical group practices; and/or d) investors who are not employed by the ASC or by any investor, are not in a position to provide items or services to the ASC or any of its investors, and are not in a position to make or influence referrals directly or indirectly to the ASC or any of its investors.

6 The ASC does not use space, including but not limited to, operating and recovery room space, or equipment, located in or owned by any hospital investor, unless such space or equipment is leased from the hospital in accordance with a lease that complies with the space or equipment rental safe harbor. The ASC does not use services provided by a investor hospital unless such services are provided in accordance with a contract that complies with the personal services safe harbor. The hospital may not include on its cost report or any claim for payment from a federal or state health care program any costs associated with the ASC (unless such costs are required to be included by a health program). The hospital is not in a position to make or influence referrals directly or indirectly to any investor or the ASC.

7 Ambulatory Surgery Centers: Multi-Specialty ASCs Stark [No comparable exception; ambulatory surgery centers exempt under Stark, not a designated health service] Anti-Kickback Safe harbor for payments on an investment interest in a multi-specialty ambulatory surgery center All requirements listed under "Ambulatory Surgery Centers: All" are met. The investors are a) physicians who are in a position to refer patients directly to the ASC and perform procedures on such referred patients ; b) group practices composed exclusively of such physicians; and/or c) investors who are not employed by the ASC or by any investor, are not in a position to provide items or services to the ASC or any of its investors, and are not in a position to make or influence referrals directly or indirectly to the ASC or any of its investors.

8 At least 1/3 of each physician investor's medical practice income from all sources for the previous fiscal year or previous 12 month period must be derived from the physician's performance of procedures that require an ASC or hospital surgical setting in accordance with Medicare reimbursement rules. At least 1/3 of the procedures that require an ASC or hospital surgical setting in accordance with Medicare reimbursement rules performed by each physician investor for the previous fiscal year or previous 12 month period must be performed at the ASC. Ambulatory Surgery Centers: Single Specialty ASCs Stark [No comparable exception; ambulatory surgery centers exempt under Stark, not a designated health service] Anti-Kickback Safe harbor for payments on an investment interest in a single-specialty ambulatory surgery center All requirements listed under "Ambulatory Surgery Centers: All" are met.

9 The investors are a) physicians engaged in the same medical practice specialty who are in a position to refer patients directly to the ASC and perform procedures on such referred patients ; b) group practices composed exclusively of such physicians; and/or c) investors who are not employed by the ASC or by any investor, are not in a position to provide items or services to the ASC or any of its investors, and are not in a position to make or influence referrals directly or indirectly to the ASC or any of its investors. At least 1/3 of each physician investor's medical practice income from all sources for the previous fiscal year or previous 12 month period must be derived from the physician's performance of procedures that require an ASC or hospital surgical setting in accordance with Medicare reimbursement rules.

10 Ambulatory Surgery Centers: Surgeon-Owned ASCs Stark [No comparable exception; ambulatory surgery centers exempt under Stark, not a designated health service] Anti-Kickback Safe harbor for payments on an investment interest in an surgeon-owned ambulatory surgery center All requirements listed under "Ambulatory Surgery Centers: All" are met. The investors are a) general surgeons or surgeons engaged in the same surgical specialty, who are in a position to refer patients directly to the ASC and perform surgery on such referred patients ; b) surgical group practices composed exclusively of such surgeons; and/or c) investors who are not employed by the ASC or by any investor, are not in a position to provide items or services to the ASC or any of its investors, and are not in a position to make or influence referrals directly or indirectly to the ASC or any of its investors.