Increased Coverage, Reduced Cost-Sharing Amounts, or Reduced Premium Amounts Offered by Health Plans -- 43

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, 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 [No comparable exception; ambulatory surgery centers Safe harbor for payments on an investment interest in ASC exempt under, not a designated health service] 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. 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 preoperational 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 [No comparable exception; ambulatory surgery centers exempt under, not a designated health service] 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. 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. 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. Ambulatory Surgery Centers: Multi-Specialty ASCs [No comparable exception; ambulatory surgery centers exempt under, not a designated health service] 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. 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 [No comparable exception; ambulatory surgery centers exempt under, not a designated health service] 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. 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. Ambulatory Surgery Centers: Surgeon-Owned ASCs [No comparable exception; ambulatory surgery centers exempt under, not a designated health service] 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. At least 1/3 of each surgeon investor's medical practice income from all sources for the previous fiscal year or previous 12 month period must be derived from the surgeon's performance of procedures that require an ASC or hospital surgical setting in accordance with Medicare reimbursement rules. Cooperative Hospital Service Organizations [No comparable exception] Safe harbor for payments between a cooperative hospital service organization (CHSO) and its patron hospital Both the CHSO and the patron hospital are described in 501(e) of the Internal Revenue Code and are tax-exempt under 501(c)(3.) The CHSO is wholly owned by two or more patron hospitals. If the patron hospital makes a payment to the CHSO, it must be for the purpose of paying for the bona fide operating expenses of the CHSO; or for the purpose of paying a distribution of net earnings required to be made under 501(e)(2) of the Internal Revenue Code.

Non-Monetary Compensation Up to $300 exception to the referral prohibition related to [No comparable safe harbor] compensation arrangements for nominal non-monetary compensation to physicians Items or services (not including cash or cash equivalents) that do not exceed an aggregate of $300 per year. The compensation is not determined in any manner that takes into account the volume or value of referrals or other business generated by the referring physician. The compensation may not be solicited by the physician or the physician's practice (including employees and staff members). The compensation arrangement does not violate the Federal anti-kickback statute or any Federal or State law or regulation governing billing or claims submission. The annual aggregate nonmonetary compensation limit is adjusted each calendar year to the nearest whole dollar by the increase in the Consumer Price Index--Urban All Items for the 12-month period ending the preceding September 30. CMS displays after September 30 each year both the increase in the CPI-U for the 12-month period and the new nonmonetary compensation limit on the physician self-referral website. Where an entity has inadvertently provided nonmonetary compensation to a physician in excess of the limit, such compensation is deemed to be within the limit if-- (i) The value of the excess nonmonetary compensation is no more than 50 percent of the limit; and (ii) The physician returns to the entity the excess nonmonetary compensation (or an amount equal to the value of the excess nonmonetary compensation) by the end of the calendar year in which the excess nonmonetary compensation was received or within

180 consecutive calendar days following the date the excess nonmonetary compensation was received by the physician, whichever is earlier. This option may be used by an entity only once every 3 years with respect to the same referring physician. In addition to nonmonetary compensation up to the limit, an entity that has a formal medical staff may provide one local medical staff appreciation event per year for the entire medical staff. Any gifts or gratuities provided in connection with the medical staff appreciation event are subject to the limit. Discounts: Buyers Who Submit Claims and Sellers Thereto [No comparable exemption] Safe harbor for discounts received by a buyer, which submits a claim for payment for the good or service for which payment is made under any federal or state health care plan and sellers to such buyers The buyer is an individual or entity (which is not an HMO or competitive medical plan or a buyer which reports its costs on a cost report) in whose name a claim or request for payment is submitted for the discounted item or service and payment may be made, in whole or in part, under a federal or state health care program. The discount must be made at the time of the sale of the goods or service or the terms of the rebate must be fixed and disclosed in writing to the buyer at the time of the initial sale of goods or services. The buyer, (if submitting the claim) must provide, upon request, to the Secretary of HHS or a state agency, the information required to be provided to a buyer by a seller. Where the seller submits a claim or request for payment on behalf of the buyer and the item or service is separately

claimed, the seller must provide, upon request by Secretary of HHS or a state agency information request to be provided to a seller by an offeror. Where the buyer submits a claim, the seller must a) fully and accurately report such discount on the invoice, coupon or statement submitted to the buyer; b) inform the buyer of its obligations to report such discount and to provide information upon request; and c) refrain from doing anything that would impede the buyer from meeting its obligations. [Note that discount "offerors" have similar requirements to sellers; an offeror is an individual or entity who is not a seller but promotes the purchase of an item or service to a buyer]. Discounts: Buyers Who Submit Cost Reports and Sellers Thereto [No comparable exception] Safe harbor for discounts received by a buyer which submits a cost report and sellers to such buyers The buyer is an entity which reports its costs on a cost report required by the Department of HHS or a state health care program. The discount must be earned based on purchases of that same good or service bought within a single fiscal year of the buyer. The buyer must claim the benefit of the discount in the fiscal year in which the discount is earned or the following year. The buyer must fully and accurately report the discount in the applicable cost report. The buyer must provide, upon request, by the Secretary of HHS or a state agency, the information required to be provided to a buyer by a seller. The seller must a) fully and accurately report such discount on the invoice, coupon or statement submitted to the buyer; b) ; b) inform the buyer of its obligations to report such

discount and to provide information upon request; and c) refrain from doing anything that would impede the buyer from meeting its obligations. If the value of the discount is not known at the time of sale, the seller must a) fully and accurately report the existence of a discount program on the invoice, coupon or statement submitted to the buyer; and when the value of the discount becomes known, provide the buyer with documentation of the calculation of the discount identifying the specific goods or services purchased to which to discount will be applied. [Note that discount "offerors" have similar requirements to sellers; an offeror is an individual or entity who is not a seller but promotes the purchase of an item or service to a buyer]. Bona Fide Employment Relationships exception to the referral prohibition related to Safe harbor for employment relationships compensation arrangements for bona fide employment relationships with physicians (or an immediate family member of the physician) The employment is for identifiable services. The employment is a bona fide employment relationship with the employer. The amount of the remuneration under the employment is: a) consistent with the fair market value of the services; and b) is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician. Subparagraph b) herein does not prohibit payment of remuneration in the form of a productivity bonus based on services performed personally by the physician (or immediate family member of the physician). The remuneration is provided under an agreement that would be commercially reasonable even if no referrals were made to the employer.

Fair Market Value Compensation exception to the referral prohibition related to [No comparable safe harbor] compensation arrangements for fair market value compensation The arrangement is between an entity and a physician (or an immediate family member) or any group of physicians (regardless of whether the group meets the definition of a group practice) for the provision of items or services (other than the rental of office space) by the physician (or an immediate family member) or group of physicians to the entity, or by the entity to the physician (or an immediate family member) or a group of physicians. The arrangement is in writing, signed by the parties, and covers only identifiable items or services, all of which are specified in the agreement. The writing specifies the timeframe for the arrangement, which can be for any period of time and contain a termination clause, provided that the parties enter into only one arrangement for the same items or services during the course of a year. An arrangement made for less than 1 year may be renewed any number of times if the terms of the arrangement and the compensation for the same items or services do not change. The writing specifies the compensation that will be provided under the arrangement. The compensation must be set in advance, consistent with fair market value, and not determined in a manner that takes into account the volume or value of referrals or other business generated by the referring physician. Compensation for the rental of equipment may not be determined using a formula based on-- (i) A percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services performed or business generated

through the use of the equipment; or (ii) Per-unit of service rental charges, to the extent that such charges reflect services provided to patients referred between the parties. The arrangement is commercially reasonable (taking into account the nature and scope of the transaction) and furthers the legitimate business purposes of the parties. The arrangment does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission. The services to be performed under the arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates a Federal or State law. Certain Group Practice Arrangements With a Hospital exception to the referral prohibition related to [No comparable safe harbor] compensation arrangements for certain arrangements between a hospital and a group practice under which designated health services are provided by the group but are billed by the hospital With respect to services provided to an inpatient, the arrangement is pursuant to the provision of inpatient services under 42 U.S.C. 1395x(b)(3) (diagnostic or therapeutic items or services as are ordinarily furnished to inpatients). The arrangement began before December 19, 1989, and has continued in effect without interruption since that date. With respect to the designated health services covered under the arrangement, at least 75 percent of these services furnished to patients of the hospital are furnished by the group under the arrangement.

The arrangement is pursuant to an agreement that is set out in writing and that specifies the services to be provided and the compensation for the services provided. The compensation paid over the term of the agreement is consistent with the fair market value. The compensation per unit of service is fixed in advance and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties. The compensation is provided pursuant to an agreement which would be commercially reasonable even if no referrals were made to the entity. Group Purchasing Organizations [No comparable exemption] Safe harbor for payments made by a vendor of goods or services to a group purchasing organization (GPO) The GPO must have a written agreement with each individual or entity for which items or services are furnished. The agreement provides for either of the following: a) the agreement states that participating vendors from which the individual or entity will purchase goods or services will pay a fee to the GPO of 3 percent or less of the purchase price of the goods or services provided by that vendor. or b) in the event the fee paid to the GPO is not fixed at 3 percent or less of the purchase price of the goods or services, the agreement specifies the amount (or if not known, the maximum amount) the GPO will be paid by each vendor (where such amount may be a fixed sum or a fixed percentage of the value of purchases made from the vendor by the members of the group under the contract between the vendor and the GPO).

Where the entity which receives the goods or service from the vendor is a health care provider of services, the GPO must disclose in writing to the entity at least annually, and to the Secretary upon request, the amount received from each vendor with respect to purchases made by or on behalf of the entity. The term group purchasing organization means an entity authorized to act as a purchasing agent for a group of individuals or entities who are furnishing services for which payment may be made in whole or in part under Medicare or a State health care program, and who are neither whollyowned by the GPO nor subsidiaries of a parent corporation that wholly owns the GPO (either directly or through another wholly-owned entity). Physician Incentive Plan exception to the referral prohibition related to [No comparable safe harbor] compensation arrangements for incentive plans between an entity and a physician The arrangement meets the requirements for of the personal services safe harbor but the compensation may be determined in a manner (through a withhold, capitation, bonus, or otherwise) that takes into account directly or indirectly the volume or value of any referrals or other business generated between the parties. No specific payment is made directly or indirectly under the plan to a physician or a physician group as an inducement to reduce or limit medically necessary services furnished with respect to a specific individual enrolled with the entity. Upon request of the Secretary of HHS, the entity provides the Secretary with access to information regarding the plan

(including any downstream subcontractor plans), in order to permit the Secretary to determine whether the plan is in compliance with this section. In the case of a plan that places a physician or a physician group at substantial financial risk as defined in Sec. 422.208, the entity (and/or any downstream contractor) complies with the requirements concerning physician incentive plans set forth at Sec. 422.208 and Sec. 422.210 of this chapter. Investments in group practices [No comparable exception] Safe harbor for any payment that is a return on an investment interest made to a solo or group practitioner investing in his own practice or group practice The equity interests in the practice or group must be held by licensed health care professionals who practice in the practice of the group. The equity interests must be in the practice or group practice itself and not a subdivision of the practice or group. In the case of a group practice, the practice must be a group practice and be a unified business with centralized decisionmaking, pooling of expenses and revenues, and a compensation/profit distribution system that is not based on satellite offices operating substantially as if they were separate enterprises or profit centers. Revenues from ancillary services, if any, must be derived from "in-office ancillary services as defined in section 1877(b)(2) of the Social Security Act. Joint Ventures in Underserved Areas

[No comparable exception] Safe harbor for payments that constitute return on an investment interest, such as dividend or interest income, made to an investor in an entity that possesses investment interests that are held by either active or passive investors No more than 50% of the value of the investment interests of each class of investments may be held in the previous fiscal year or previous 12 month period by investors who are in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity. The terms on which an investment interest is offered to a passive investor, if any, who is in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity must be no different from the terms offered to other passive investors. The terms on which an investment interest is offered to an investor who is in a position to make or influence referrals to or generate business for the entity must not be related to the previous or expected volume of referrals, or the amount of business generated from the investor to the entity. Passive investors are not be required to either make referrals to, or otherwise generate business for the entity as a condition for remaining as an investor. The entity or any investor must not market or furnish the entity's items or services to passive investors differently than to non-investors. At least 75% of the dollar volume of the entity's business in the previous fiscal year or previous 12 month period must be derived from the service of persons who reside in an underserved area or are members of medically underserved populations. The entity or any investor must not loan funds to or guarantee a loan for any investor who is in a position to make or influence referrals to or generate business for the entity if

the investor uses any part of the loan to obtain the investment interest. The amount of the payment to an investor in return for the investment must be directly proportional to the amount of the capital investment. Isolated Transactions exception to the referral prohibition related to [No comparable safe harbor] compensation arrangements for isolated financial transactions with a physician, such as a one-time sale of property or a practice The amount of the remuneration under the transaction is consistent with the fair market value of the services. The amount of remuneration under the transaction is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician or other business generated between the parties. The remuneration is provided under an agreement that would be commercially reasonable even if the physician made no referrals. There are no additional transactions between the parties for 6 months after the isolated transaction, except for transactions which are specifically excepted under the other provisions of the regulations and except for commercially reasonable post- closing adjustments that do not take into account (directly or indirectly) the volume or value of referrals or other business generated by the referring physician. Equipment Leases exception to the referral prohibition related to compensation arrangements for rental of equipment between Safe harbor for payments made by a lessee to a lessor for the use of equipment

an entity and a referring physician A rental or lease agreement is set out in writing and signed by the parties and specifies the equipment covered by the The lease agreement is set out in writing and signed by the parties. lease. The equipment rented or leased does not exceed that which is reasonable and necessary for the legitimate business purposes of the lease or rental and is used exclusively by the The lease covers all of the equipment leased between the parties for the term of the lease and specifies the equipment covered by the lease. lessee when being used by the lessee and is not shared with or used by the lessor or any person or entity related to the lessor. The lease provides for a term of rental or lease of at least 1 year. If the agreement is terminated during the term with or without cause, the parties may not enter into a new agreement during the first year of the original term of the agreement. A holdover month-to-month rental for up to 6 If the lease is intended to provide the lessee with use of the equipment for periodic intervals of time, rather than on a fulltime basis for the term of the lease, the lease specifies exactly the schedule of such intervals, their precise length, and the exact rent for such interval. months immediately following an agreement of at least 1 year will satisfy this paragraph, provided the holdover rental is on the same terms and conditions as the immediately preceding agreement. The rental charges over the term of the agreement are set in The term of the lease is for not less than one year. advance, are consistent with fair market value, and are not determined (i) In a manner that takes into account the volume or value of any referrals or other business generated between the parties; or (ii) Using a formula based on (A) A percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services performed on or business generated by the use of the equipment; or (B) Perunit of service rental charges, to the extent that such charges reflect services provided to patients referred between the parties. The lease would be commercially reasonable even if no referrals were made between the parties. The aggregate rental charge is set in advance, is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated

between the parties for which payment may be made in whole or in part under Medicare or a State health care program. The aggregate equipment rental does not exceed that which is reasonably necessary to accomplish the commercially reasonable business purpose of the rental. The term fair market value means the value of the equipment when obtained from a manufacturer or professional distributor, but shall not be adjusted to reflect the additional value one party (either the prospective lessee or lessor) would attribute to the equipment as a result of its proximity or convenience to sources of referrals or business otherwise generated for which payment may be made in whole or in part under Medicare or a State health care program. Space Leases exception to the referral prohibition related to compensation arrangements for rental of office space Safe harbor for payments made by a lessee to a lessor for the use of space between an entity and a referring physician The agreement is set out in writing, is signed by the parties, and specifies the premises it covers. The term of the agreement is at least 1 year. To meet this requirement, if the agreement is terminated during the term with or without cause, the parties may not enter into a new The lease agreement is set out in writing and signed by the parties. The lease covers all of the premises leased between the parties for the term of the lease and specifies the premises covered by the lease. agreement during the first year of the original term of the agreement. A holdover month-to-month rental for up to 6 months immediately following an agreement of at least 1 year that met the conditions of this paragraph (a) will satisfy this paragraph (a), provided the holdover rental is on the same terms and conditions as the immediately preceding agreement. The space rented or leased does not exceed that which is If the lease is intended to provide the lessee with access to

reasonable and necessary for the legitimate business purposes of the lease or rental and is used exclusively by the lessee when being used by the lessee (and is not shared with or used by the lessor or any person or entity related to the the premises for periodic intervals of time, rather than on a full-time basis for the term of the lease, the lease specifies exactly the schedule of such intervals, their precise length, and the exact rent for such intervals. lessor), except that the lessee may make payments for the use of space consisting of common areas if the payments do not exceed the lessee's pro rata share of expenses for the space based upon the ratio of the space used exclusively by the lessee to the total amount of space (other than common areas) occupied by all persons using the common areas. The rental charges over the term of the agreement are set in The term of the lease is for not less than one year. advance and are consistent with fair market value. The rental charges over the term of the agreement are not determined-- (i) In a manner that takes into account the volume or value of any referrals or other business generated between the parties; or (ii) Using a formula based on (A) A percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services performed or business generated in the office space; or (B) Per-unit of service rental The aggregate rental charge is set in advance, is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare or a State health care program. charges, to the extent that such charges reflect services provided to patients referred between the parties. The agreement would be commercially reasonable even if no referrals were made between the lessee and the lessor. The aggregate space rented does not exceed that which is reasonably necessary to accomplish the commercially reasonable business purpose of the rental. The term fair market value means the value of the rental property for general commercial purposes, but shall not be adjusted to reflect the additional value that one party (either the prospective lessee or lessor) would attribute to the property as a result of its proximity or convenience to sources of referrals or business otherwise generated for which payment may be made in whole or in part under Medicare or a State health care program. Practitioner Recruitment

exception to the referral prohibition related to compensation arrangements for physician recruitment Safe harbor for payments by an entity to induce a practitioner to relocate a practice into a Health Professional Shortage Area (HPSA) for his/her specialty area The remuneration, provided by a hospital to recruit a physician, is paid directly to the physician and is intended to induce the physician to relocate his or her medical practice to the geographic area served by the hospital in order to become a member of the hospital's medical staff. The arrangement is set out in writing and signed by both parties. The payments are to induce a practitioner who has been practicing within his or her current specialty for less than one year to locate, or to induce any other practitioner to relocate, his or her primary place of practice into a HPSA for his or her specialty area that is served by the entity. The arrangement is set forth in a written agreement signed by the parties that specifies the benefits provided by the entity, the terms under which the benefits are to be provided, and the obligations of each party. The arrangement is not conditioned on the physician's referral of patients to the hospital. If a practitioner is leaving an established practice, at least 75 percent of the revenues of the new practice must be generated from new patients not previously seen by the practitioner at his or her former practice. The hospital does not determine (directly or indirectly) the amount of the remuneration to the physician based on the volume or value of any actual or anticipated referrals by the physician or other business generated between the parties. The benefits are provided by the entity for a period not in excess of 3 years, and the terms of the agreement are not renegotiated during this 3-year period in any substantial aspect; provided, however, that if the HPSA to which the practitioner was recruited ceases to be a HPSA during the term of the written agreement, the payments made under the written agreement will continue to satisfy this paragraph for the duration of the written agreement (not to exceed 3 years). The physician is allowed to establish staff privileges at any other hospital(s) and to refer business to any other entities (except as referrals may be restricted under a separate employment or services contract). There is no requirement that the practitioner make referrals to, be in a position to make or influence referrals to, or otherwise generate business for the entity as a condition for receiving the benefits; provided, however, that for purposes of this paragraph, the entity may require as a condition for receiving benefits that the practitioner maintain staff privileges at the entity. In the case of remuneration provided by a hospital to a The practitioner is not restricted from establishing staff

physician either indirectly through payments made to another physician practice, or directly to a physician who joins a physician practice, the following additional conditions must be met: (a) the written agreement also signed by the party to whom the payments are directly made; (b) except for actual costs incurred by the physician practice in recruiting the new physician, the remuneration is passed directly through to or remains with the recruited physician; (c) in the case of an income guarantee of any type made by the hospital to a recruited physician who joins a physician practice, the costs allocated by the physician practice to the recruited physician do not exceed the actual additional incremental costs attributable to the recruited physician. With respect to a physician recruited to join a physician practice located in a rural area or HPSA, if the physician is recruited to replace a physician who, within the previous 12-month period, retired, relocated outside of the geographic area served by the hospital, or died, the costs allocated by the physician practice to the recruited physician do not exceed either-- (1) the actual additional incremental costs attributable to the recruited physician; or (2) the lower of a per capita allocation or 20 percent of the practice's aggregate costs; (d) records of the actual costs and the passed-through amounts are maintained for a period of at least 5 years and made available to the Secretary of HHS upon request; (e) the remuneration from the hospital under the arrangement is not determined in a manner that takes into account (directly or indirectly) the volume or value of any actual or anticipated referrals by the recruited physician or the physician practice (or any physician affiliated with the physician practice) receiving the direct payments from the hospital; (f) the physician practice may not impose on the recruited physician practice restrictions that unreasonably restrict the recruited physician's ability to practice medicine in the geographic area served by the hospital; and (g) the arrangement does not violate the antiprivileges at, referring any service to, or otherwise generating any business for any other entity of his or her choosing.

kickback statute or any Federal or State law or regulation governing billing or claims submission. Recruitment of a physician by a hospital located in a rural area to an area outside the geographic area served by the hospital is permitted under this exception if the Secretary of HHS determines in an advisory opinion that the area has a demonstrated need for the recruited physician and all other requirements for recruiting are met. These requirements apply to remuneration provided by a federally qualified health center or a rural health clinic in the same manner as it applies to remuneration provided by a hospital, provided that the arrangement does not violate the anti-kickback statute or any Federal or State law or regulation governing billing or claims submission. The amount or value of the benefits provided by the entity may not vary (or be adjusted or renegotiated) in any manner based on the volume or value of any expected referrals to or business otherwise generated for the entity by the practitioner for which payment may be made in whole or in part under Medicare, Medicaid or any other Federal health care programs. The practitioner agrees to treat patients receiving medical benefits or assistance under any Federal health care program in a nondiscriminatory manner. At least 75 percent of the revenues of the new practice must be generated from patients residing in a HPSA or a Medically Underserved Area (MUA) or who are part of a Medically Underserved Population (MUP). The payment or exchange of anything of value may not directly or indirectly benefit any person (other than the practitioner being recruited) or entity in a position to make or influence referrals to the entity providing the recruitment payments or benefits of items or services payable by a

Federal health care program. Waiver of Beneficiary Coinsurance and Deductible Amounts [No comparable exception] Safe harbor for reduction or waiver of a federal or state health program beneficiary's obligation to pay coinsurance or deductible amounts If the coinsurance or deductible amounts are owed to a hospital for inpatient hospital services for which Medicare pays under the prospective payment system, the hospital must comply with all of the following three standards: a) the hospital must not later claim the amount reduced or waived as a bad debt for payment purposes under Medicare or otherwise shift the burden of the reduction or waiver onto Medicare, a State health care program, other payers, or individuals; b) the hospital must offer to reduce or waive the coinsurance or deductible amounts without regard to the reason for admission, the length of stay of the beneficiary, or the diagnostic related group for which the claim for Medicare reimbursement is filed; c) the hospital's offer to reduce or waive the coinsurance or deductible amounts must not be made as part of a price reduction agreement between a hospital and a third-party payer (including a health plan), unless the agreement is part of a contract for the furnishing of items or services to a beneficiary of a Medicare supplemental policy. If the coinsurance or deductible amounts are owed by an individual who qualifies for subsidized services under a provision of the Public Health Services Act or under titles V or XIX of the Social Security Act to a federally qualified health care center or other health care facility under any Public Health Services Act grant program or under title V of the Act, the health care center or facility may reduce or waive the coinsurance or deductible amounts for items or services for

which payment may be made in whole or in part under part B of Medicare or a State health care program. Warranties [No comparable exception] Safe harbor for any payment or exchange of anything of value under a warranty provided by a manufacturer or supplier of an item to the buyer The buyer must fully and accurately report any price reduction of the item (including a free item), which was obtained as part of the warranty, in the applicable cost reporting mechanism or claim for payment filed with the Department or a State agency. The buyer must provide, upon request by the Secretary of HHS or a State agency, the information required to be provided by the manufacturer or supplier. The manufacturer or supplier must fully and accurately report the price reduction of the item (including a free item), which was obtained as part of the warranty, on the invoice or statement submitted to the buyer, and inform the buyer of its obligations; and/or where the amount of the price reduction is not known at the time of sale, the manufacturer or supplier must fully and accurately report the existence of a warranty on the invoice or statement, inform the buyer of its obligations, and, when the price reduction becomes known, provide the buyer with documentation of the calculation of the price reduction resulting from the warranty. The manufacturer or supplier must not pay any remuneration to any individual (other than a beneficiary) or entity for any medical, surgical, or hospital expense incurred by a beneficiary other than for the cost of the item itself. The term warranty means either an agreement made in accordance with the provisions of 15 U.S.C. 2301(6), or a

manufacturer's or supplier's agreement to replace another manufacturer's or supplier's defective item (which is covered by an agreement made in accordance with this statutory provision), on terms equal to the agreement that it replaces. Personal Services and Management Contracts exception to the referral prohibition related to compensation arrangements for personal services or Safe harbor for remuneration from an entity under an personal service arrangement or management contract management The arrangement is set out in writing, is signed by the parties, and specifies the services covered by the arrangement. The agency agreement covers all of the services the agent provides to the principal for the term of the agreement and specifies the services to be provided by the agent. The arrangement(s) covers all of the services to be furnished by the physician (or an immediate family member of the physician) to the entity. This requirement is met if all separate The agency agreement covers all of the services the agent provides to the principal for the term of the agreement and specifies the services to be provided by the agent. arrangements between the entity and the physician and the entity and any family members incorporate each other by reference or if they cross-reference a master list of contracts that is maintained and updated centrally and is available for review by the Secretary of HHS upon request. The master list must be maintained in a manner that preserves the historical record of contracts. A physician or family member can "furnish" services through employees whom they have hired for the purpose of performing the services; through a whollyowned entity; or through locum tenens physicians (as defined at Sec. 411.351, except that the regular physician need not be a member of a group practice). The aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement(s). If the agency agreement is intended to provide for the services of the agent on a periodic, sporadic or part-time basis, rather than on a full-time basis for the term of the agreement, the agreement specifies exactly the schedule of such intervals, their precise length, and the exact charge for such intervals.

The term of each arrangement is for at least 1 year. To meet The term of the agreement is for not less than one year. this requirement, if an arrangement is terminated during the term with or without cause, the parties may not enter into the same or substantially the same arrangement during the first year of the original term of the arrangement. The compensation to be paid over the term of each arrangement is set in advance, does not exceed fair market value, and, except in the case of a physician incentive plan (as defined at Sec. 411.351 of this subpart), is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties. The aggregate compensation paid to the agent over the term of the agreement is set in advance, is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare or a State health care program. The services to be furnished under each arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates any Federal or The services performed under the agreement do not involve the counselling or promotion of a business arrangement or other activity that violates any state or federal law. State law. A holdover personal service arrangement for up to 6 months following the expiration of an agreement of at least 1 year that met all of the above conditions satisfies the requirements, provided that the holdover personal service arrangement is on the same terms and conditions as the immediately preceding agreement. The aggregate services contracted for do not exceed those which are reasonably necessary to accomplish the commercially reasonable business purpose of the services. Sale of Practice [No comparable exception] Safe harbor for payments made to a practitioner by another practitioner where first practitioner is selling a practice to the second practitioner The period from the date of the first agreement pertaining to the sale to the completion of the sale is not more than one

year. The practitioner who is selling his or her practice will not be in a professional position to make referrals to, or otherwise generate business for, the purchasing practitioner for which payment may be made in whole or in part under Medicare or a State health care program after one year from the date of the first agreement pertaining to the sale. Remuneration under this provision does not include any payment made to a practitioner by a hospital or other entity where the practitioner is selling his or her practice to the hospital or other entity, so long as the following four standards are met: a) the period from the date of the first agreement pertaining to the sale to the completion date of the sale is not more than three years; b) the practitioner who is selling his or her practice will not be in a professional position after completion of the sale to make or influence referrals to, or otherwise generate business for, the purchasing hospital or entity for which payment may be made in whole or in part under Medicare or a State health care program; c) the practice being acquired must be located in a Health Professional Shortage Area (HPSA), as defined in Departmental regulations, for the practitioner's specialty area; d) commencing at the time of the first agreement pertaining to the sale, the purchasing hospital or entity must diligently and in good faith engage in commercially reasonable recruitment activities that may reasonably be expected to result in the recruitment of a new practitioner to take over the acquired practice within a one year period and will satisfy the conditions of the practitioner recruitment safe harbor. Referral Services exception to the referral prohibition related to compensation arrangements for referral services Safe harbor for payments between an individual or entity ("participant") and another entity serving as a referral source

("referral service") Remuneration that meets all of the conditions in the antikickback safe harbor for referral services. The referral service does not exclude as a participant in the referral service any individual or entity who meets the qualifications for participation. Any payment the participant makes to the referral service is assessed equally against and collected equally from all participants, and is only based on the cost of operating the referral service, and not on the volume or value of any referrals to or business otherwise generated by either party for the other party for which payment may be made in whole or in part under Medicare or a State health care program. The referral service imposes no requirements on the manner in which the participant provides services to a referred person, except that the referral service may require that the participant charge the person referred at the same rate as it charges other persons not referred by the referral service, or that these services be furnished free of charge or at reduced charge. The referral service makes the following five disclosures to each person seeking a referral, with each such disclosure maintained by the referral service in a written record certifying such disclosure and signed by either such person seeking a referral or by the individual making the disclosure on behalf of the referral service: a) the manner in which it selects the group of participants in the referral service to which it could make a referral; b) whether the participant has paid a fee to the referral service; c) the manner in which it selects a particular participant from this group for that person; d) the nature of the relationship between the referral service and the group of participants to whom it could make the referral; and e) the nature of any restrictions that would exclude such an individual or entity from continuing as a participant.

Price Reductions Offered to Health Plans [No comparable exception] Safe harbor for a reduction in price a contract health care provider offers to a health plan for the sole purpose of furnishing to enrollees items or services that are covered by the health plan, Medicare, or a State health care program There is a written agreement between the parties. If the health plan is a risk-based health maintenance organization, competitive medical plan, or prepaid health plan under contract with CMS or a State agency under a Federal statutory demonstration authority, or under other Federal statutory or regulatory authority, the contract health care provider must not claim payment in any form from the Department or the State agency for items or services furnished in accordance with the agreement except as approved by CMS or the State health care program, or otherwise shift the burden of such an agreement to the extent that increased payments are claimed from Medicare or a State health care program. If the health plan is a health maintenance organization, competitive medical plan, health care prepayment plan, prepaid health plan, or other health plan that has executed a contract or agreement with CMS or a State health care program to receive payment for enrollees on a reasonable cost or similar basis, the health plan and contract health care provider must comply with all of the following four standards: a) the term of the agreement between the health plan and the contract health care provider must be for not less than one year; b) the agreement between the health plan and the contract health care provider must specify in advance the covered items and services to be furnished to enrollees, and the methodology for computing the payment to the contract health care provider; c) the health plan must fully and accurately report, on the applicable cost report or other claim

form filed with the Department or the State health care program, the amount it has paid the contract health care provider under the agreement for the covered items and services furnished to enrollees; and d) the contract health care provider must not claim payment in any form from the Department or the State health care program for items or services furnished in accordance with the agreement except as approved by CMS or the State health care program, or otherwise shift the burden of such an agreement to the extent that increased payments are claimed from Medicare or a State health care program. If the health plan is not described in two paragraphs above and the contract health care provider is not paid on an at-risk, capitated basis, both the health plan and contract health care provider must comply with all of the following six standards: a) the term of the agreement between the health plan and the contract health care provider must be for not less than one year; b) the agreement between the health plan and the contract health care provider must specify in advance the covered items and services to be furnished to enrollees, which party is to file claims or requests for payment with Medicare or the State health care program for such items and services, and the schedule of fees the contract health care provider will charge for furnishing such items and services to enrollees; c) the fee schedule contained in the agreement between the health plan and the contract health care provider must remain in effect throughout the term of the agreement, unless a fee increase results directly from a payment update authorized by Medicare or the State health care program; d) the party submitting claims or requests for payment from Medicare or the State health care program for items and services furnished in accordance with the agreement must not claim or request payment for amounts in excess of the fee schedule; e) the contract health care provider and the health plan must fully and accurately report on any cost

report filed with Medicare or a State health care program the fee schedule amounts charged in accordance with the agreement and, upon request, will report to the Medicare or a State health care program the terms of the agreement and the amounts paid in accordance with the agreement; and f) the party to the agreement, which does not have the responsibility under the agreement for filing claims or requests for payment, must not claim or request payment in any form from the Department or the State health care program for items or services furnished in accordance with the agreement, or otherwise shift the burden of such an agreement to the extent that increased payments are claimed from Medicare or a State health care program. If the health plan is not described in the first two paragraphs above, and the contract health care provider is paid on an atrisk, capitated basis, both the health plan and contract health care provider must comply with all of the following five standards: a) the term of the agreement between the health plan and the contract health provider must be for not less than one year; b) the agreement between the health plan and the contract health provider must specify in advance the covered items and services to be furnished to enrollees and the total amount per enrollee (which may be expressed in a per month or other time period basis) the contract health care provider will be paid by the health plan for furnishing such items and services to enrollees and must set forth any copayments, if any, to be paid by enrollees to the contract health care provider for covered services; c) the payment amount contained in the agreement between the health care plan and the contract health care provider must remain in effect throughout the term of the agreement; d) the contract health care provider and the health plan must fully and accurately report to the Medicare and State health care program upon request, the terms of the agreement and the amounts paid in accordance with the agreement; and e) the

contract health care provider must not claim or request payment in any form from the Department, a State health care program or an enrollee (other than copayment amounts described in (b) and the health plan must not pay the contract care provider in excess of the amounts described in (b) for items and services covered by the agreement. Medical Staff Incidental Benefits exception to the referral prohibition related to [No comparable safe harbor] compensation arrangements from a hospital to a member of its medical staff The compensation is in the form of items or services (not including cash or cash equivalents) from a hospital to a member of its medical staff when the item or service is used on the hospital's campus. The compensation is provided to all members of the medical staff practicing in the same specialty (but not necessarily accepted by every member to whom it is offered) without regard to the volume or value of referrals or other business generated between the parties. Except with respect to identification of medical staff on a hospital Web site or in hospital advertising, the compensation is provided only during periods when the medical staff members are making rounds or are engaged in other services or activities that benefit the hospital or its patients. The compensation is provided by the hospital and used by the medical staff members only on the hospital's campus. Compensation, including, but not limited to, Internet access, pagers, or two-way radios, used away from the campus only to access hospital medical records or information or to access patients or personnel who are on the hospital campus, as well as the identification of the medical staff on a hospital web site or in hospital advertising, will meet the "on

campus" requirement. The compensation is reasonably related to the provision of, or designed to facilitate directly or indirectly the delivery of, medical services at the hospital. The compensation is of low value (that is, less than $25) with respect to each occurrence of the benefit (for example, each meal given to a physician while he or she is serving patients who are hospitalized must be of low value). The $25 limit in this paragraph (m)(5) will be adjusted each calendar year to the nearest whole dollar by the increase in the Consumer Price Index-Urban All Items (CPI-U) for the 12-month period ending the preceding September 30. CMS intends to display as soon as possible after September 30 each year both the increase in the CPI-U for the 12-month period and the new limits on the physician self- referral Web site. The compensation is not determined in any manner that takes into account the volume or value of referrals or other business generated between the parties. The compensation arrangement does not violate the antikickback statute or any federal or state law or regulation governing billing or claims submission. Other facilities and health care clinics (including, but not limited to, federally qualified health centers) that have bona fide medical staffs may provide compensation under this paragraph on the same terms and conditions applied to hospitals. Risk Sharing Arrangements [No comparable safe harbor] exception to the referral prohibition related to a compensation arrangement that is a risk- sharing arrangement (including, but not limited to, withholds, bonuses, and risk pools) The arrangement is between a managed care organization or

an independent physicians association and a physician (either directly or indirectly through a subcontractor) for services provided to enrollees of a health plan. The arrangement does not violate the federal anti-kickback statute or any law or regulation governing billing or claims submission. "Health plan" and "enrollees" have the meanings ascribed to those terms in the anti-kickback regulations. Compliance Training exception to the referral prohibition related to a [No comparable safe harbor] compensation arrangement for compliance training The training is provided by an entity to a physician (or to the physician's immediate family member or office staff) who practices in the entity's local community or service area. The training is held in the local community or service area. "Compliance training" means training regarding the basic elements of a compliance program (for example, establishing policies and procedures, training of staff, internal monitoring, or reporting); specific training regarding the requirements of Federal and State health care programs (for example, billing, coding, reasonable and necessary services, documentation, or unlawful referral arrangements); or training regarding other Federal, State, or local laws, regulations, or rules governing the conduct of the party for whom the training is provided. "Compliance training'' also includes programs that offer continuing medical education credit, provided that compliance training is the primary purpose of the program. Indirect Compensation Arrangements exception to the referral prohibition related to a [No comparable safe harbor] compensation arrangement for indirect compensation

arrangements The arrangement is an indirect compensation arrangement. The compensation received by the referring physician (or immediate family member) described in 411.354(c)(2)(ii) is fair market value for services and items actually provided and not determined in any manner that takes into account the volume or value of referrals or other business generated by the referring physician for the entity furnishing DHS. Compensation for the rental of office space or equipment may not be determined using a formula based on-- (A) A percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services performed or business generated in the office space or to the services performed or business generated through the use of the equipment; or (B) Per-unit of service rental charges, to the extent that such charges reflect services provided to patients referred between the parties. The indirect compensation arrangement is set out in writing, signed by the parties, and specifies the services covered by the arrangement, except in the case of a bona fide employment relationship between an employer and an employee, in which case the arrangement need not be set out in a written contract, but must be for identifiable services and be commercially reasonable even if no referrals are made to the employer. The compensation arrangement does not violate the antikickback statute or any laws or regulations governing billing or claims submission. Ambulance Restocking: All [No comparable exception] Safe harbor for ambulance restocking programs The ambulance that is replenished must be used to provide

emergency ambulance services an average of three times per week, as measured over a reasonable period of time. Drugs and medical supplies (including linens) initially used by a first responder and replenished at the scene of the illness or injury by the ambulance provider that transports the patient to the hospital or other receiving facility will be deemed to have been used by the ambulance provider.. Under no circumstances may the ambulance provider (or first responder) and the receiving facility both bill for the same replenished drug or supply. Replenished drugs or supplies may only be billed (including claiming bad debt) to a Federal health care program by either the ambulance provider (or first responder) or the receiving facility. All billing or claims submission by the receiving facility, ambulance provider or first responder for replenished drugs and medical supplies used in connection with the transport of a Federal health care program beneficiary must comply with all applicable Federal health care program payment and coverage rules and regulations. Compliance with this paragraph will be determined separately for the receiving facility and the ambulance provider (and first responder, if any), so long as the receiving facility, ambulance provider (or first responder) refrains from doing anything that would impede the other party or parties from meeting their obligations under this paragraph. The receiving facility or ambulance provider, or both, must: a) maintain records of the replenished drugs and medical supplies and the patient transport to which the replenished drugs and medical supplies related; b) provide a copy of such records to the other party within a reasonable time (unless the other party is separately maintaining records of the replenished drugs and medical supplies); and c) make those records available to the Secretary of HHS promptly upon request. A pre-hospital care report (including, but not limited

to, a trip sheet, patient care report or patient encounter report) prepared by the ambulance provider and filed with the receiving facility will meet the requirements of this paragraph, provided that it documents the specific type and amount of medical supplies and drugs used on the patient and subsequently replenished. For purposes of this paragraph, documentation may be maintained and, if required, filed with the other party in hard copy or electronically. If a replenishing arrangement includes linens, documentation need not be maintained for their exchange. If documentation is not maintained for the exchange of linens, the receiving facility will be presumed to have provided an exchange of comparable clean linens for soiled linens for each ambulance transport of a patient to the receiving facility. Records required under this section must be maintained for 5 years. The replenishing arrangement must not take into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under any Federal health care program (other than the referral of the particular patient to whom the replenished drugs and medical supplies were furnished. The receiving facility and the ambulance provider otherwise comply with all Federal, State, and local laws regulating ambulance services, including, but not limited to, emergency services, and the provision of drugs and medical supplies, including, but not limited to, laws relating to the handling of controlled substances. The arrangement must satisfy all of the standards in one of three categories: general replenishing, fair market value replenishing, or government-mandated replenishing. A receiving facility is a hospital or other facility that provides emergency medical services. An ambulance provider is a provider or supplier of ambulance transport services that

provides emergency ambulance services. The term does not include a provider of ambulance transport services that provides only non-emergency transport services. A first responder includes, but is not limited to, a fire department, paramedic service or search and rescue squad that responds to an emergency call (through 911 or other emergency access number) and treats the patient, but does not transport the patient to the hospital or other receiving facility. An emergency ambulance service is a transport by ambulance initiated as a result of a call through 911 or other emergency access number or a call from another acute care facility unable to provide the higher level care required by the patient and available at the receiving facility. Medical supplies includes linens, unless otherwise provided. Ambulance Restocking: General Replenishing [No comparable exception] Safe harbor for ambulance restocking programs The arrangement meets all of the requirements for applicable to all ambulance restocking arrangements. The receiving facility must replenish medical supplies or drugs on an equal basis for all ambulance providers that bring patients to the receiving facility in any one of the following categories: a) all ambulance providers that do not bill any patient or insurer (including Federal health care programs) for ambulance services, regardless of the payor or the patient's ability to pay (i.e., ambulance providers, such as volunteer companies, that provide ambulance services without charge to any person or entity); b) all not-for-profit and State or local government ambulance service providers (including, but not limited to, municipal and volunteer ambulance services providers); or c) all ambulance service providers. A receiving facility may offer replenishing to one or more of

the categories and may offer different replenishing arrangements to different categories, so long as the replenishing is conducted uniformly within each category. For example, a receiving facility may offer to replenish a broader array of drugs or supplies for ambulance providers that do no not charge for their services than for ambulance providers that charge for their services. Within each category, the receiving facility may limit its replenishing arrangements to the replenishing of emergency ambulance transports only. The replenishing arrangement must be conducted in an open and public manner. A replenishing arrangement will be considered to be conducted in an open and public manner if one of the following two conditions are satisfied: a) a written disclosure of the replenishing program is posted conspicuously in the receiving facility's emergency room or other location where the ambulance providers deliver patients and copies are made available upon request to ambulance providers, Government representatives, and members of the public (subject to reasonable photocopying charges). The written disclosure can take any reasonable form and should include the category of ambulance service providers that qualifies for replenishment; the drugs or medical supplies included in the replenishment program; and the procedures for documenting the replenishment. No written contracts between the parties are required; or b) the replenishment arrangement operates in accordance with a plan or protocol of general application promulgated by an Emergency Medical Services (EMS) Council or comparable entity, agency or organization, provided a copy of the plan or protocol is available upon request to ambulance providers, Government representatives and members of the public (subject to reasonable photocopying charges). While parties are encouraged to participate in collaborative, comprehensive, community-wide EMS systems to improve the delivery of EMS in their local communities, nothing in this paragraph

shall be construed as requiring the involvement of such organizations or the development or implementation of ambulance replenishment plans or protocols by such organizations. Disclosure of confidential proprietary or financial information related to the replenishing arrangement (including, but not limited to, information about cost, pricing or the volume of replenished drugs or supplies) to ambulance providers or members of the general public is not required. Ambulance Restocking: Fair Market Value Replenishing [No comparable exception] Safe harbor for ambulance restocking programs The arrangement meets all of the requirements for applicable to all ambulance restocking arrangements The ambulance provider must pay the receiving facility fair market value, based on an arms-length transaction, for replenished medical supplies. If payment is not made at the same time as the replenishing of the medical supplies, the receiving facility and the ambulance provider must make commercially reasonable payment arrangements in advance. Ambulance Restocking: Government Mandated Replenishing [No comparable exception] Safe harbor for ambulance restocking programs The arrangement meets all of the requirements for applicable to all ambulance restocking arrangements. The replenishing arrangement is undertaken in accordance with a State or local statute, ordinance, regulation or binding protocol that requires hospitals or receiving facilities in the area subject to such requirement to replenish ambulances that deliver patients to the hospital with drugs or medical

supplies (including linens) that are used during the transport of that patient. Physician Services exception to the referral prohibition related to both [No comparable safe harbor ownership/investment and compensation arrangements for certain physician services The services are physicians' services, including diagnosis, therapy, surgery, consultations, and home, office, and institutional calls. The services are provided a) personally by another physician who is a member of the referring physician's group practice or is a physician in the same group practice as the referring physician; or b) under the supervision of another physician who is a member of the referring physician's group practice or is a physician in the same group practice as the referring physician, provided that the supervision complies with all other applicable Medicare payment and coverage rules for the physician services. "Physician services'" includes only those "incident to" services ( the services or supplies are furnished as an integral, although incidental, part of the physician's personal professional services in the course of diagnosis or treatment of an injury or illness) that are physician services. All other "incident to'" services (for example, diagnostic tests, physical therapy) are outside the scope of this section. Increased Coverage, Reduced Cost-Sharing Amounts, or Reduced Premium Amounts Offered by Health Plans [No comparable exception] Safe harbor for increased coverage, reduced cost-sharing amounts, or reduced premium amounts offered by health plans

If the health plan is a risk-based health maintenance organization, competitive medical plan, prepaid health plan, or other health plan under contract with CMS or a State health care program and operating under a Federal statutory demonstration authority, or under other Federal statutory or regulatory authority, it must offer the same increased coverage or reduced cost-sharing or premium amounts to all Medicare or State health care program enrollees covered by the contract unless otherwise approved by CMS or by a State health care program. If the health plan is a health maintenance organization, competitive medical plan, health care prepayment plan, prepaid health plan or other health plan that has executed a contract or agreement with CMS or with a State health care program to receive payment for enrollees on a reasonable cost or similar basis, it must comply with both of the following two standards: a) the health plan must offer the same increased coverage or reduced cost-sharing or premium amounts to all Medicare or State health care program enrollees covered by the contract or agreement unless otherwise approved by CMS or by a State health care program; and b) the health plan must not claim the costs of the increased coverage or the reduced cost-sharing or premium amounts as a bad debt for payment purposes under Medicare or a State health care program or otherwise shift the burden of the increased coverage or reduced costsharing or premium amounts to the extent that increased payments are claimed from Medicare or a State health care program. Obstetrical Malpractice Insurance Subsidies exception to the referral prohibition related to Safe harbor for obstetrical malpractice insurance subsidies compensation arrangements for obstetrical malpractice insurance subsidiaries

Payments to a referring physician that meet all of the conditions in the anti-kickback safe harbor for obstetrical malpractice insurance subsidiaries; OR all of the following: The payment is made by a hospital or other entity to another entity that is providing malpractice insurance (including a selffunded entity), where such payment is used to pay for some or all of the costs of malpractice insurance premiums for a practitioner (including a certified nurse- midwife) who engages in obstetrical practice as a routine part of his or her medical practice in a primary care health professional shortage area ("HPSA"). The payment is from a hospital, federally qualified health center, or rural health clinic that is used to pay for some or all of the costs of malpractice insurance premiums for a physician who engages in obstetrical practice as a routine part of his or her medical practice. The physician s medical practice is located in a rural area, a primary care HPSA, or an area with demonstrated need for the physician s obstetrical services as determined by the Secretary in an advisory opinion; or at least 75 percent of the physician s obstetrical patients reside in a medically underserved area or are members of a medically underserved population. The payment is made in accordance with a written agreement between the entity paying the premiums and the practitioner, which sets out the payments to be made by the entity, and the terms under which the payments are to be provided. The practitioner must certify that for the initial coverage period (not to exceed one year) the practitioner has a reasonable basis for believing that at least 75 percent of the practitioner's obstetrical patients treated under the coverage of the malpractice insurance will either: a) reside in a HPSA or medically underserved area ('MUA"); or b) be part of a medically underserved population ("MUP"). Thereafter, for each additional coverage period (not to exceed one year), at least 75 percent of the practitioner's obstetrical patients treated under the prior coverage period (not to exceed one year) must have: a) resided in a HPSA or MUA; or b) been part of a MUP. The arrangement is set out in writing, is signed by the physician and the hospital, federally qualified health center, or rural health clinic providing the payment, and specifies the There is no requirement that the practitioner make referrals to, or otherwise generate business for, the entity as a condition for receiving the benefits. payments to be made by the hospital, federally qualified health center, or rural health clinic and the terms under which the payments are to be provided. The arrangement is not conditioned on the physician s referral of patients to the hospital, federally qualified health center, or rural health clinic providing the payment. The practitioner is not restricted from establishing staff privileges at, referring any service to, or otherwise generating any business for any other entity of his or her choosing.

The hospital, federally qualified health center, or rural health clinic does not determine (directly or indirectly) the amount of the payment based on the volume or value of any actual or anticipated referrals by the physician or any other business generated between the parties. The amount of payment may not vary based on the volume or value of any previous or expected referrals to or business otherwise generated for the entity by the practitioner for which payment may be made in whole or in part under Medicare, Medicaid or any other Federal health care program. The physician is allowed to establish staff privileges at any hospital(s), federally qualified health center(s), or rural health clinic(s) and to refer business to any other entities (except as The practitioner must treat obstetrical patients who receive medical benefits or assistance under any Federal health care program in a nondiscriminatory manner. referrals may be restricted under an employment arrangement or services contract). The payment is made to a person or organization (other than the physician) that is providing malpractice insurance (including a self-funded organization). The insurance is a bona fide malpractice insurance policy or program, and the premium, if any, is calculated based on a bona fide assessment of the liability risk covered under the insurance. The physician treats obstetrical patients who receive medical benefits or assistance under any Federal health care program in a nondiscriminatory manner. (viii) The insurance is a bona fide malpractice insurance policy or program, and the premium, if any, is calculated based on a bona fide assessment of the liability risk covered under the insurance. Costs of malpractice insurance premiums means: a) for practitioners who engage in obstetrical practice full-time, any costs attributable to malpractice insurance; or b) for practitioners who engage in obstetrical practice on a parttime or sporadic basis, the costs: attributable exclusively to the obstetrical portion of the practitioner's malpractice insurance and related exclusively to obstetrical services provided in a primary care HPSA. For each coverage period (not to exceed 1 year), at least 75 percent of the physician s obstetrical patients treated under the coverage of the obstetrical malpractice insurance during the prior period (not to exceed 1 year)-- (1) Resided in a rural area, HPSA, medically underserved area, or an area with a demonstrated need for the physician s obstetrical services as determined by the Secretary in an advisory opinion issued in accordance with section 1877(g)(6) of the Act; or (2) Were part of a medically underserved population. For the initial coverage period (not to exceed 1 year), the requirements of will be satisfied if the physician certifies that he or she has a

reasonable expectation that at least 75 percent of the physician's obstetrical patients treated under the coverage of the malpractice insurance will (1) Reside in a rural area, HPSA, medically underserved area, or an area with a demonstrated need for the physician s obstetrical services as determined by the Secretary in an advisory opinion; or (2) Be part of a medically underserved population. The arrangement does not violate the anti-kickback statute of the Act), or any Federal or State law or regulation governing billing or claims submission. The costs of malpractice insurance premiums means: (i) For physicians who engage in obstetrical practice on a full-time basis, any costs attributable to malpractice insurance; or (ii) For physicians who engage in obstetrical practice on a parttime or sporadic basis, the costs attributable exclusively to the obstetrical portion of the physician's malpractice insurance, and related exclusively to obstetrical services provided-- (A) In a rural area, primary care HPSA, or an area with demonstrated need for the physician s obstetrical services, as determined by the Secretary in an advisory opinion; or (B) In any area, provided that at least 75 percent of the physician's obstetrical patients treated in the coverage period (not to exceed 1 year) resided in a rural area or medically underserved area or were part of a medically underserved population. Referral Agreements for Specialty Services [No comparable exemption] Safe harbor for specialty service referral agreements The agreement is for one party to refer a patient to the other party for the provision of a specialty service payable in whole or in part under Medicare or a State health care program in return for an agreement on the part of the other party to refer that patient back at a mutually agreed upon time or

circumstance. The mutually agreed upon time or circumstance for referring the patient back to the originating individual or entity is clinically appropriate. The service for which the referral is made is not within the medical expertise of the referring individual or entity, but is within the special expertise of the other party receiving the referral. The parties receive no payment from each other for the referral and do not share or split a global fee from any Federal health care program in connection with the referred patient. Unless both parties belong to the same group practice, the only exchange of value between the parties is the remuneration the parties receive directly from third-party payors or the patient compensating the parties for the services they each have furnished to the patient. Price Reductions Offered by Contractors With Substantial Financial Risk to Managed Care Organizations [No comparable exception] Safe harbor for price reductions offered by contractors with substantial financial risk to managed care organizations This safe harbor is too long to reprint. Click on the link above to go directly to the regulatory language. Price Reductions Offered to Eligible Managed Care Organizations. [No comparable exception] Safe harbor for price reductions offered by contractors with substantial financial risk to managed care organizations This safe harbor is too long to reprint. Click on the link above to go directly to the regulatory language. Large Investment Interests

exception to the referral prohibition related to Safe harbor for certain investment interests ownership or investment interests The ownership of must be of investment securities (including shares or bonds, debentures, notes, or other debt instruments) that at the time the designated health service referral was made could be purchased on the open market. The investment is in an entity with more than $50,000,000 in undepreciated net tangible assets (based on the net acquisition cost of purchasing such assets from an unrelated entity) related to the furnishing of health care items and services. The investment securities are a) listed for trading on the New York Stock Exchange, the American Stock Exchange, or any regional exchange in which quotations are published on a With respect to an investment interest that is an equity security, the equity security must be registered with the Securities and Exchange Commission. daily basis, or foreign securities listed on a recognized foreign, national, or regional exchange in which quotations are published on a daily basis; or b) traded under an automated interdealer quotation system operated by the National Association of Securities Dealers. The investment securities are in a corporation that had stockholder equity exceeding $75 million at the end of the corporation's most recent fiscal year or on average during the previous 3 fiscal years. "Stockholder equity" is the difference in value between a corporation's total assets and total liabilities. The investment interest of an investor in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity must be obtained on terms (including any direct or indirect transferability restrictions) and at a price equally available to the public when trading on a registered securities exchange, such as the New York Stock Exchange or the American Stock Exchange, or in accordance with the National Association of Securities Dealers Automated Quotation System. The entity or any investor must not market or furnish the entity's items or services (or those of another entity as part of a cross referral agreement) to passive investors differently than to non- investors. The entity or any investor (or other individual or entity acting on behalf of the entity or any investor in the entity) must not loan funds to or guarantee a loan for an investor who is in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity if

the investor uses any part of such loan to obtain the investment interest. The amount of payment to an investor in return for the investment interest must be directly proportional to the amount of the capital investment of that investor. Mutual Funds exception to the referral prohibition related to [No comparable safe harbor] ownership or investment interests for mutual funds Investment or ownership of shares in a regulated investment company as defined in section 851(a) of the Internal Revenue Code of 1986, if the company had, at the end of its most recent fiscal year, or on average during the previous 3 fiscal years, total assets exceeding $75 million. Investment Interests in Entity With Investment Interests Held by Either Active or Passive Investors [No comparable exception] Safe harbor for certain investment interests The investment is in an entity which possesses investment interests that are held by either active or passive investors. No more than 40 percent of the value of the investment interests of each class of investment interests may be held in the previous fiscal year or previous 12 month period by investors who are in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity. Equivalent classes of equity investments may be combined, and equivalent classes of debt instruments may be combined. The terms on which an investment interest is offered to a passive investor, if any, who is in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity must be no

different from the terms offered to other passive investors. The terms on which an investment interest is offered to an investor who is in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity must not be related to the previous or expected volume of referrals, items or services furnished, or the amount of business otherwise generated from that investor to the entity. There is no requirement that a passive investor, if any, make referrals to, be in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity as a condition for remaining as an investor. The entity or any investor must not market or furnish the entity's items or services (or those of another entity as part of a cross referral agreement) to passive investors differently than to non- investors. No more than 40 percent of the entity's gross revenue related to the furnishing of health care items and services in the previous fiscal year or previous 12-month period may come from referrals or business otherwise generated from investors. The entity or any investor (or other individual or entity acting on behalf of the entity or any investor in the entity) must not loan funds to or guarantee a loan for an investor who is in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity if the investor uses any part of such loan to obtain the investment interest. The amount of payment to an investor in return for the investment interest 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.

Investment Interests in Entity Located in a Rural or Underserved Area exception to the referral prohibition related to Safe harbor for certain investment interests ownership or investment interests An investment or ownership interest in an entity that furnishes substantially all (not less than 75 percent) of the designated health services that it furnishes to residents of a The investment is in an entity which possesses investment interests that are held by either active or passive investors and is located in an underserved area. rural area and, for the 18-month period beginning on December 8, 2003 (or such other period as Congress may specify), is not a specialty hospital. A rural area is an area that is not an urban area as defined in Sec. 412.62(f)(1)(ii) of this chapter. No more than 50 percent of the value of the investment interests of each class of investments may be held in the previous fiscal year or previous 12-month period by investors who are in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for, the entity. Equivalent classes of equity investments may be combined, and equivalent classes of debt instruments may be combined. The terms on which an investment interest is offered to a passive investor, if any, who is in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity must be no different from the terms offered to other passive investors. The terms on which an investment interest is offered to an investor who is in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity must not be related to the previous or expected volume of referrals, items or services furnished, or the amount of business otherwise generated from that investor to the entity. There is no requirement that a passive investor, if any, make referrals to, be in a position to make or influence referrals to,

furnish items or services to, or otherwise generate business for the entity as a condition for remaining as an investor. The entity or any investor must not market or furnish the entity's items or services (or those of another entity as part of a cross-referral agreement) to passive investors differently than to non- investors. At least 75 percent of the dollar volume of the entity's business in the previous fiscal year or previous 12-month period must be derived from the service of persons who reside in an underserved area or are members of medically underserved populations. The entity or any investor (or other individual or entity acting on behalf of the entity or any investor in the entity) must not loan funds to or guarantee a loan for an investor who is in a position to make or influence referrals to, furnish items or services to, or otherwise generate business for the entity if the investor uses any part of such loan to obtain the investment interest. The amount of payment to an investor in return for the investment interest 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. If an entity that otherwise meets all of the above standards is located in an area that was an underserved area at the time of the initial investment, but subsequently ceases to be an underserved area, the entity will be deemed to comply with this section for a period equal to the lesser of: a) the current term of the investment remaining after the date upon which the area ceased to be an underserved area; or b) three years from the date the area ceased to be an underserved area. Hospital Investment or Ownership

exception to the referral prohibition related to [No comparable safe harbor] ownership or investment interests for certain hospital investments NOTE: This exception has been significantly changed by the Patient Protection and Affordable Care Act. Review the changes Investment or ownership in a hospital if: a) the referring physician is authorized to perform services at the hospital; b) effective for the 18-month period beginning on December 8, 2003 (or such other period as Congress may specify), the hospital is not a specialty hospital; and c) the ownership or investment interest is in the entire hospital and not merely in a distinct part or department of the hospital. Preventive Screening Tests, Immunizations, and Vaccines exception related to both ownership/investment and [No comparable safe harbor compensation The preventive screening tests, immunizations, and vaccines must be covered by Medicare and must be listed as eligible for this exception on the List of CPT/HCPCS Codes. The preventive screening tests, immunizations, and vaccines are subject to CMS-mandated frequency limits. The arrangement for the provision of the preventive screening tests, immunizations, and vaccines does not violate the anti-kickback statute. All billing and claims submission for the preventive screening tests, immunizations, and vaccines does not violate any federal or state law or regulation governing billing or claims submission. Eyeglasses and Contact Lenses Following Cataract Surgery

exception related to both ownership/investment and [No comparable safe harbor] compensation The eyeglasses and contact lenses are covered by Medicare when furnished to patients following cataract surgery. The eyeglasses or contact lenses are provided in accordance with the coverage and payment provisions set forth in Sec. 410.36(a)(2)(ii) and Sec. 414.228. The arrangement for the furnishing of the eyeglasses or contact lenses does not violate the federal anti-kickback statute. Billing and claims submission for the eyeglasses or contact lenses complies with all federal and state laws and regulations. EPO and Other Dialysis-Related Drugs Furnished in or by an ESRD Facility exception related to both ownership/investment and [No comparable safe harbor compensation The EPO and other dialysis-related drugs are furnished in or by an ESRD facility. " EPO and other dialysis-related drugs" means certain outpatient prescription drugs that are required for the efficacy of dialysis and identified as eligible for this exception on the List of CPT/HCPCS Codes; and "furnished" means that the EPO or dialysis-related drugs are administered to a patient in the ESRD facility, or, in the case of EPO or Aranesp (or equivalent drug identified on the List of CPT/HCPCS Codes) only, are dispensed by the ESRD facility for use at home. The arrangement for the furnishing of the EPO and other dialysis-related drugs does not violate the anti-kickback statute. All billing and claims submission for the EPO and other

dialysis-related drugs does not violate any Federal or State law or regulation governing billing or claims submission. This exception does not apply to any financial relationships between the referring physician and any entity other than the ESRD facility that furnishes the EPO and other dialysisrelated drugs to the patient. Implants in an ASC exception related to both ownership/investment and [No comparable safe harbor] compensation Implants are furnished by an ambulatory surgery center and include, but are not limited to, cochlear implants, intraocular lenses, and other implanted prosthetics, implanted prosthetic devices, and implanted DME. The implant is implanted by the referring physician or a member of the referring physician's group practice in a Medicare-certified ASC with which the referring physician has a financial relationship. The implant is implanted in the patient during a surgical procedure paid by Medicare to the ASC as an ASC procedure. The arrangement for the furnishing of the implant does not violate the federal anti-kickback statute. All billing and claims submission for the implants does not violate any federal or state law or regulation governing billing or claims submission. This exception does not apply to any financial relationships between the referring physician and any entity other than the ASC in which the implant is furnished to, and implanted in, the patient. Academic Medical Centers

exception related to both ownership/investment and [No comparable safe harbor] compensation for services provided by an academic medical center The referring physician a) is a bona fide employee of a component of the academic medical center on a full-time or substantial part-time basis. (A ``component'' of an academic medical center means an affiliated medical school, faculty practice plan, hospital, teaching facility, institution of higher education, departmental professional corporation, or nonprofit support organization whose primary purpose is supporting the teaching mission of the academic medical center. The components need not be separate legal entities); b) is licensed to practice medicine in the State(s) in which he or she practices medicine; c) has a bona fide faculty appointment at the affiliated medical school or at one or more of the educational programs at the accredited academic hospital; and d) provides either substantial academic services or substantial clinical teaching services (or a combination of academic services and clinical teaching services) for which the faculty member receives compensation as part of his or her employment relationship with the academic medical center. Parties should use a reasonable and consistent method for calculating a physician's academic services and clinical teaching services. A physician will be deemed to meet this requirement if he or she spends at least 20 percent of his or her professional time or 8 hours per week providing academic services or clinical teaching services (or a combination of academic services or clinical teaching services). A physician who does not spend at least 20 percent of his or her professional time or 8 hours per week providing academic services or clinical teaching services (or a combination of academic services or clinical teaching services) is not precluded from qualifying. The total compensation paid by all academic medical center

components to the referring physician is set in advance and, in the aggregate, does not exceed fair market value for the services provided, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated by the referring physician within the academic medical center. All transfers of money between components of the academic medical center must directly or indirectly support the missions of teaching, indigent care, research, or community service. The relationship of the components of the academic medical center must be set forth in written agreement(s) or other written document(s) that have been adopted by the governing body of each component. If the academic medical center is one legal entity, this requirement will be satisfied if transfers of funds between components of the academic medical center are reflected in the routine financial reports covering the components. All money paid to a referring physician for research must be used solely to support bona fide research or teaching and must be consistent with the terms and conditions of the grant. The referring physician's compensation arrangement does not violate the anti-kickback statute, or any federal or state law or regulation governing billing or claims submission. The "academic medical center" consists of: a) an accredited medical school (including a university, when appropriate) or an accredited academic hospital (as defined at Sec. 411.355(e)(3)); b) 0ne or more faculty practice plans affiliated with the medical school, the affiliated hospital(s), or the accredited academic hospital; and c) one or more affiliated hospital(s) in which a majority of the physicians on the medical staff consists of physicians who are faculty members and a majority of all hospital admissions are made by physicians who are faculty members.

A faculty member is a physician who is either on the faculty of the affiliated medical school or on the faculty of one or more of the educational programs at the accredited academic hospital. Faculty from any affiliated medical school or accredited academic hospital education program may be aggregated, and residents and non- physician professionals need not be counted. Any faculty member may be counted, including courtesy and volunteer faculty. An accredited academic hospital means a hospital or a health system that sponsors four or more approved medical education programs. Services Furnished by an Organization to Enrollees exception related to both ownership/investment and [No comparable safe harbor] compensation The services are furnished by an organization (or its contractors or subcontractors) to enrollees of one of the following prepaid health plans (not including services provided to enrollees in any other plan or line of business offered or administered by the same organization): a) an HMO or a CMP in accordance with a contract with CMS, which set forth qualifying conditions for Medicare contracts; enrollment, entitlement, and disenrollment under Medicare contracts; Medicare contract requirements; and change of ownership and leasing of facilities: effect on Medicare contracts; b) a health care prepayment plan in accordance with an agreement with CMS; c) an organization that is receiving payments on a prepaid basis for Medicare enrollees through a demonstration project; d) a qualified HMO; e) a coordinated care plan offered by an organization in accordance with a contract with CMS; f) a managed care organization (MCO) contracting with a State; g) a prepaid inpatient health plan or prepaid ambulance health plan

contracting with a State; h) a health insuring organization (HIO) contracting with a State; and i) an entity operating under a demonstration project under sections 1115(a), 1915(a), 1915(b), or 1932(a) of the Act. In-Office Ancillaries exception related to both ownership/investment and [No comparable safe harbor] compensation for in-house ancillary services NOTE: This exception has been modified by the Patient Protection and Affordable Care Act. Review the changes. Services are all designated health services and can include certain items of durable medical equipment (DME), and infusion pumps that are DME (including external ambulatory infusion pumps), but excluding all other DME and parenteral and enteral nutrients, equipment, and supplies (such as infusion pumps used for PEN)) The services are furnished personally by one of the following individuals: a) the referring physician.; b) a physician who is a member of the same group practice as the referring physician; or c) an individual who is supervised by the referring physician or by another physician in the group practice, provided the supervision complies with all other applicable Medicare payment and coverage rules for the services They are furnished in one of the following locations: The same building, but not necessarily in the same space or part of the building, in which one of the following conditions are satisfied: a. The referring physician or his or her group practice (if any) has an office that is normally open to the physician's or group's patients for medical services at least 35 hours per

week; and the referring physician or one or more members of the referring physician's group practice regularly practices medicine and furnishes physician services to patients at least 30 hours per week. (The 30 hours must include some physician services that are unrelated to the furnishing of designated health services payable by Medicare, any other federal health care payer, or a private payer, even though the physician services may lead to the ordering of designated health services; or b. the patient receiving the designated health services usually receives physician services from the referring physician or members of the referring physician's group practice (if any) and the referring physician or the referring physician's group practice owns or rents an office that is normally open to the physician's or group's patients for medical services at least 8 hours per week; and the referring physician regularly practices medicine and furnishes physician services to patients at least 6 hours per week. (The 6 hours must include some physician services that are unrelated to the furnishing of designated health services payable by Medicare, any other federal health care payer, or a private payer, even though the physician services may lead to the ordering of designated health services; or c. the referring physician is present and orders the designated health services during a patient visit on the premises or the referring physician or a member of the referring physician's group practice (if any) is present while the designated health service is furnished during

occupancy of the premises; and the referring physician or the referring physician's group practice owns or rents an office that is normally open to the physician's or group's patients for medical services at least 8 hours per week; and the referring physician or one or more members of the referring physician's group practice regularly practices medicine and furnishes physician services to patients at least 6 hours per week. The 6 hours must include some physician services that are unrelated to the furnishing of designated health services payable by Medicare, any other federal health care payer, or a private payer, even though the physician services may lead to the ordering of designated health services. A centralized building that is used by the group practice for the provision of some or all of the group practice's clinical laboratory services; or A centralized building that is used by the group practice for the provision of some or all of the group practice's DHS (other than clinical laboratory services). The services must be billed by one of the following: a) the physician performing or supervising the service; b) the group practice of which the performing or supervising physician is a member under a billing number assigned to the group practice; c) the group practice if the supervising physician is a "physician in the group" under a billing number assigned to the group practice; d) an entity that is wholly owned by the performing or supervising physician or by that physician's group practice under the entity's own billing number or under a billing number assigned to the physician or group practice; e) an independent third party billing company acting as an agent of the physician, group practice, or entity under a billing number assigned to the physician, group practice, or entity,

provided the billing arrangement meets the requirements of Sec. 424.80(b)(6) of this chapter. A group practice may have, and bill under, more than one Medicare billing number, subject to any applicable Medicare program restrictions DME covered by the in-office ancillary services exception means canes, crutches, walkers and folding manual wheelchairs, and blood glucose monitors, that meet the following conditions: The item is one that a patient requires for the purposes of ambulating, uses in order to depart from the physician's office, or is a blood glucose monitor (including one starter set of test strips and lancets, consisting of no more than 100 of each). A blood glucose monitor may be furnished only by a physician or employee of a physician or group practice that also furnishes outpatient diabetes self- management training to the patient. The item is furnished in a building that meets the "same building" requirements in the in-office ancillary services exception as part of the treatment for the specific condition for which the patient-physician encounter occurred. The item is furnished personally by the physician who ordered the DME, by another physician in the group practice, or by an employee of the physician or the group practice. A physician or group practice that furnishes the DME meets all DME supplier standards located in Sec. 424.57(c) of this chapter. The arrangement does not violate the antikickback statute or any federal or state law or regulation governing billing or claims submission. All other requirements of the in-office ancillary

services exception are met. In the case of a referring physician whose principal medical practice consists of treating patients in their private homes, the "same building" requirements are met if the referring physician (or a qualified person accompanying the physician, such as a nurse or technician) provides the designated health services contemporaneously with a physician service that is not a designated health service provided by the referring physician to the patient in the patient's private home. A private home does not include a nursing, long-term care, or other facility or institution, except that a patient may have a private home in an assisted living or independent living facility. Charitable Donations by a Physician exception related to compensation arrangements for [No comparable safe harbor] charitable donations The donations are bona fide charitable donations made by a physician (or immediate family member) to an entity. The charitable donation is made to an organization exempt from taxation under the Internal Revenue Code (or to a supporting organization). The donation is neither solicited, nor offered, in any manner that takes into account the volume or value of referrals or other business generated between the physician and the entity. The donation arrangement does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission. Professional Courtesy

exception related to compensation arrangements for [No comparable safe harbor] professional courtesies Professional courtesy that is offered by an entity with a formal medical staff to a physician or a physician's immediate family member or office staff. The professional courtesy is offered to all physicians on the entity's bona fide medical staff or in such entity's local community or service area without regard to the volume or value of referrals or other business generated between the parties. The health care items and services provided are of a type routinely provided by the entity. The entity has a professional courtesy policy that is set out in writing and approved in advance by the entity's governing body. The professional courtesy is not offered to a physician (or immediate family member) who is a Federal health care program beneficiary, unless there has been a good faith showing of financial need. The arrangement does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission. Community-Wide Health Information Systems exception related to compensation arrangements for [No comparable safe harbor] health information systems Items or services of information technology are provided by an entity to a physician to allow access to, and sharing of, electronic health care records and any complementary drug information systems, general health information, medical alerts, and related information for patients served by community providers and practitioners, in order to enhance

the community's overall health. The items or services are available as necessary to enable the physician to participate in a community-wide health information system, are principally used by the physician as part of the community-wide health information system, and are not provided to the physician in any manner that takes into account the volume or value of referrals or other business generated by the physician. The community-wide health information systems are available to all providers, practitioners, and residents of the community who desire to participate. The arrangement does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission. Retention Payments in Underserved Areas exception related to compensation arrangements for [No comparable safe harbor] retention payments in underserved areas Remuneration is provided by a hospital directly to a physician on the hospital's medical staff to retain the physician's medical practice in the geographic area served by the hospital. The physician has a bona fide firm, written recruitment offer or offer of employment from a hospital, academic medical center or physician organization that is not related to the hospital making the payment, and the offer specifies the remuneration being offered and requires the physician to move the location of his or her medical practice at least 25 miles and outside of the geographic area served by the hospital making the retention payment. In lieu of a bona fide written offer, the physician furnishes to the hospital before the retention payment is made a written

certification that the physician has a bona fide opportunity for future employment by a hospital, academic medical center or physician organization that requires the physician to move the location of his or her medical practice at least 25 miles and outside the geographic area served by the hospital and the certification contains at least the following-- (A) Details regarding the steps taken by the physician to effectuate the employment opportunity; (B) Details of the physician's employment opportunity, including the identity and location of the physician's future employer or employment location or both, and the anticipated income and benefits (or a range for income and benefits); (C) A certification that the future employer is not related to the hospital making the payment; (D) The date on which the physician anticipates relocating his or medical practice outside of the geographic area served by the hospital; and (E) Information sufficient for the hospital to verify the information included in the written certification; and the hospital takes reasonable steps to verify that the physician has a bona fide opportunity for future employment that requires the physician to relocate outside the geographic area served by the hospital. All requirements of the exception for physician recruitment are met. Any retention payment is subject to the same obligations and restrictions, if any, on repayment or forgiveness of indebtedness as the written recruitment offer or offer of employment. This requirement does not apply in the case of a certification of employment. In the case of a bona fide written offer, the retention payment does not exceed the lower of-- (A) The amount obtained by subtracting the physician's current income from physician and related services from the income the physician would receive from comparable physician and related services in the written recruitment or employment offer, provided that the respective

incomes are determined using a reasonable and consistent methodology, and that they are calculated uniformly over no more than a 24-month period; or (B) The reasonable costs the hospital would otherwise have to expend to recruit a new physician to the geographic area served by the hospital to join the medical staff of the hospital to replace the retained physician. In the case of a certification of employment, the retention payment does not exceed the lower of-- (A) An amount equal to 25 percent of the physician's current income (measured over no more than a 24-month period), using a reasonable and consistent methodology that is calculated uniformly; or (B) The reasonable costs the hospital would otherwise have to expend to recruit a new physician to the geographic area served by the hospital to join the medical staff of the hospital to replace the retained physician. The physician's current medical practice is located in a rural area or HPSA (regardless of the physician's specialty) or is located in an area with demonstrated need for the physician as determined by the Secretary of HHS in an advisory opinion; or (B) At least 75 percent of the physician's patients reside in a medically underserved area or are members of a medically underserved population. The hospital does not enter into a retention arrangement with a particular referring physician more frequently than once every 5 years. The amount and terms of the retention payment are not altered during the term of the arrangement in any manner that takes into account the volume or value of referrals or other business generated by the physician. The arrangement does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission.

The above requirements apply to remuneration provided by a federally qualified health center or a rural health clinic in the same manner as it applies to remuneration provided by a hospital. Intra-Family Rural Referrals exception related to both ownership/investment and [No comparable safe harbor] compensation for intra-family referrals in rural areas Services are provided pursuant to a referral from a referring physician to his or her immediate family member or to an entity furnishing designated health services with which the immediate family member has a financial relationship. The patient who is referred resides in a rural area. No other person or entity is available to furnish the services in a timely manner in light of the patient's condition within 25 miles of the patient's residence; except in the case of services furnished to patients where they reside (for example, home health services or in-home DME), no other person or entity is available to furnish the services in a timely manner in light of the patient's condition. The financial relationship does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission The referring physician or the immediate family member must make reasonable inquiries as to the availability of other persons or entities to furnish the designated health services. However, neither the referring physician nor the immediate family member has any obligation to inquire as to the availability of persons or entities located farther than 25 miles from the patient's residence. Unrelated Remuneration

exception related to compensation arrangement for [No comparable safe harbor] unrelated remuneration Remuneration provided by a hospital to a physician that does not relate, directly or indirectly, to the furnishing of designated health services. Remuneration relates to the furnishing of designated health services if it: a) is an item, service, or cost that could be allocated in whole or in part to Medicare or Medicaid under cost reporting principles; b)is furnished, directly or indirectly, explicitly or implicitly, in a selective, targeted, preferential, or conditioned manner to medical staff or other persons in a position to make or influence referrals; or c) otherwise takes into account the volume or value of referrals or other business generated by the referring physician. The remuneration must be wholly unrelated to the furnishing of DHS and must not in any way take into account the volume or value of a physician's referrals. Federally Qualified Health Centers [No comparable exception] Safe harbor for payments and other transfers made to a Federally Qualified Health Center The transfer is made pursuant to a contract, lease, grant, loan, or other agreement that-- (A) is set out in writing; (B) is signed by the parties; and (C) covers, and specifies the amount of, all goods, items, services, donations, or loans to be provided by the individual or entity to the FQHC. The amount of goods, items, services, donations, or loans specified in the agreement may be a fixed sum, fixed percentage, or set forth by a fixed methodology. The amount may not be conditioned on the volume or value of federal health care program business generated between

the parties. The goods, items, services, donations, or loans are medical or clinical in nature or relate directly to services provided by the FQHC as part of the scope of the FQHC section 330 grant (including, by way of example, billing services, administrative support services, technology support, and enabling services, such as case management, transportation, and translation services, that are within the scope of the grant). The FQHC reasonably expects the arrangement to contribute meaningfully to the FQHC's ability to maintain or increase the availability, or enhance the quality, of services provided to a medically underserved population served by the FQHC, and the FQHC documents the basis for the reasonable expectation prior to entering the arrangement. The documentation must be made available to the Secretary upon request. At reasonable intervals, but at least annually, the FQHC must re-evaluate the arrangement to ensure that the arrangement is expected to continue to satisfy the standards, and must document the re-evaluation contemporaneously. The documentation must be made available to the Secretary upon request. Arrangements must not be renewed or renegotiated unless the FQHC reasonably expects the standard to be satisfied in the next agreement term. Renewed or renegotiated agreements must comply with the requirements of this paragraph. The individual or entity making the payment or transfer does not (i) require the FQHC (or its affiliated health care professionals) to refer patients to a particular individual or entity, or (ii) restrict the FQHC (or its affiliated health care professionals) from referring patients to any individual or entity. Individuals and entities that offer to furnish goods, items, or services without charge or at a reduced charge to the FQHC

must furnish such goods, items, or services to all patients from the FQHC who clinically qualify for the goods, items, or services, regardless of the patient's payor status or ability to pay. The individual or entity may impose reasonable limits on the aggregate volume or value of the goods, items, or services furnished under the arrangement with the FQHC, provided such limits do not take into account a patient's payor status or ability to pay. The agreement must not restrict the FQHC's ability, if it chooses, to enter into agreements with other providers or suppliers of comparable goods, items, or services, or with other lenders or donors. Where a FQHC has multiple individuals or entities willing to offer comparable remuneration, the FQHC must employ a reasonable methodology to determine which individuals or entities to select and must document its determination. The FQHC must provide effective notification to patients of their freedom to choose any willing provider or supplier. In addition, the FQHC must disclose the existence and nature of an agreement to any patient who inquires. The FQHC must provide such notification or disclosure in a timely fashion and in a manner reasonably calculated to be effective and understood by the patient. The FQHC may, at its option, elect to require that an individual or entity charge a referred FQHC patient the same rate it charges other similarly situated patients not referred by the FQHC or that the individual or entity charge a referred FQHC patient a reduced rate (where the discount applies to the total charge and not just to the cost-sharing portion owed by an insured patient). Electronic Prescribing Items and Services exception related to compensation arrangements Safe harbor for payments made for electronic prescribing

items and services The remuneration is nonmonetary and consists of items and services in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription information. The items and services are provided by a (i) a hospital to a physician who is a member of its medical staff; (ii) a group practice to a physician who is a member of the group; or (iii) a PDP sponsor or MA organization to a prescribing physician. The remuneration is nonmonetary and consists of items and services in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription information. The items and services are provided by a (i) hospital to a physician who is a member of its medical staff; (ii) group practice to a prescribing health care professional who is a member of the group practice; and (iii) PDP sponsor or MA organization to pharmacists and pharmacies participating in the network of such sponsor or organization and to prescribing health care professionals. The items and services are provided as part of, or are used to access, an electronic prescription drug program that meets the applicable standards under Medicare Part D at the time the items and services are provided. The donor (or any person on the donor's behalf) does not take any action to limit or restrict the use or compatibility of the items or services with other electronic prescribing or electronic health records systems. For items or services that are of the type that can be used for any patient without regard to payor status, the donor does not restrict, or take any action to limit, the physician's right or ability to use the items or services for any patient. Neither the physician nor the physician's practice (including employees and staff members) makes the receipt of the items or services, or the amount or nature of the items or services, a condition of doing business with the donor. Neither the eligibility of a physician for the items or services, nor the amount or nature of the items or services, is determined in a manner that takes into account the volume or value of referrals or other business generated between the parties. The items and services are provided as part of, or are used to access, an electronic prescription drug program that meets the applicable standards under Medicare Part D at the time the items and services are provided. The donor (or any person on the donor's behalf) does not take any action to limit or restrict the use or compatibility of the items or services with other electronic prescribing or electronic health records systems. For items or services that are of the type that can be used for any patient without regard to payor status, the donor does not restrict, or take any action to limit, the physician's right or ability to use the items or services for any patient. Neither the recipient nor the recipient's practice (or any affiliated individual or entity) makes the receipt of items or services, or the amount or nature of the items or services, a condition of doing business with the donor. Neither the eligibility of a physician for the items or services, nor the amount or nature of the items or services, is determined in a manner that takes into account the volume or value of referrals or other business generated between the parties.

The arrangement is set forth in a written agreement that (i) is signed by the parties; (ii) specifies the items and services being provided and the donor's cost of the items and services; and (iii) covers all of the electronic prescribing items and services to be provided by the donor. This requirement will be met if all separate agreements between the donor and the physician (and the donor and any family members of the physician) incorporate each other by reference or if they cross-reference a master list of agreements that is maintained and updated centrally and is available for review by the Secretary of HHS upon request. The master list should be maintained in a manner that preserves the historical record of agreements. The donor does not have actual knowledge of, and does not act in reckless disregard or deliberate ignorance of, the fact that the physician possesses or has obtained items or services equivalent to those provided by the donor. The arrangement is set forth in a written agreement that (i) is signed by the parties; (ii) specifies the items and services being provided and the donor's cost of the items and services; and (iii) covers all of the electronic prescribing items and services to be provided by the donor (or affiliated parties). This requirement will be met if all separate agreements between the donor (and affiliated parties) and the recipient incorporate each other by reference or if they cross-reference a master list of agreements that is maintained and updated centrally and is available for review by the Secretary of HHS upon request. The master list should be maintained in a manner that preserves the historical record of agreements. The donor does not have actual knowledge of, and does not act in reckless disregard or deliberate ignorance of, the fact that the recipient possesses or has obtained items or services equivalent to those provided by the donor. Electronic Health Records Items and Services exception related to compensation arrangements The remuneration is nonmonetary and consists of items and services in the form of software or information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records. The items and services are provided by an entity to a physician. Safe harbor for payments made for electronic health records The remuneration is nonmonetary and consists of items and services in the form of software or information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records. The items and services are provided to an individual or entity engaged in the delivery of health care by (i) an individual or entity that provides services covered by a Federal health care program and submits claims or requests for payment, either directly or through reassignment, to the Federal health care program; or (ii) a health plan. The software is interoperable at the time it is provided to the physician. Software is deemed to be interoperable if a The software is interoperable at the time it is provided to the recipient. Software is deemed to be interoperable if a

certifying body recognized by the Secretary of HHS has certified the software no more than 12 months prior to the date it is provided to the physician. The donor (or any person on the donor's behalf) does not take any action to limit or restrict the use, compatibility or interoperability of the items or services with other electronic prescribing or electronic health records systems. Before receipt of the items and services, the physician pays 15 percent of the donor's cost for the items and services. The donor (or any party related to the donor) does not finance the physician's payment or loan funds to be used by the physician to pay for the items and services. Neither the physician nor the physician's practice (including employees and staff members) makes the receipt of items or services, or the amount or nature of the items or services, a condition of doing business with the donor. Neither the eligibility of a physician for the items or services, nor the amount or nature of the items or services, is determined in a manner that directly takes into account the volume or value of referrals or other business generated between the parties. For purposes of this paragraph, the determination is deemed not to directly take into account the volume or value of referrals or other business generated between the parties if any one of the following conditions is met: (i) the determination is based on the total number of prescriptions written by the physician (but not the volume or value of prescriptions dispensed or paid by the donor or billed to the program); (ii) the determination is based on the size of the physician's medical practice (for example, total patients, total patient encounters, or total relative value units); (iii) the determination is based on the total number of hours that the certifying body recognized by the Secretary of HHS has certified the software within no more than 12 months prior to the date it is provided to the recipient. The donor (or any person on the donor's behalf) does not take any action to limit or restrict the use, compatibility or interoperability of the items or services with other electronic prescribing or electronic health records systems. Before receipt of the items and services, the recipient pays 15 percent of the donor's cost for the items and services. The donor (or any affiliated individual or entity) does not finance the recipient's payment or loan funds to be used by the recipient to pay for the items and services. Neither the recipient nor the recipient's practice (or any affiliated individual or entity) makes the receipt of items or services, or the amount or nature of the items or services, a condition of doing business with the donor. Neither the eligibility of a recipient for the items or services, nor the amount or nature of the items or services, is determined in a manner that directly takes into account the volume or value of referrals or other business generated between the parties. For the purposes of this paragraph, the determination is deemed not to directly take into account the volume or value of referrals or other business generated between the parties if any one of the following conditions is met: (i) the determination is based on the total number of prescriptions written by the recipient (but not the volume or value of prescriptions dispensed or paid by the donor or billed to a Federal health care program); (ii) the determination is based on the size of the recipient's medical practice (for example, total patients, total patient encounters, or total relative value units); (iii) the determination is based on the

physician practices medicine; (iv) the determination is based on the physician's overall use of automated technology in his or her medical practice (without specific reference to the use of technology in connection with referrals made to the donor); (v) the determination is based on whether the physician is a member of the donor's medical staff, if the donor has a formal medical staff; (vi) the determination is based on the level of uncompensated care provided by the physician; or (vii) the determination is made in any reasonable and verifiable manner that does not directly take into account the volume or value of referrals or other business generated between the parties. total number of hours that the recipient practices medicine; (iv) the determination is based on the recipient's overall use of automated technology in his or her medical practice (without specific reference to the use of technology in connection with referrals made to the donor); (v) the determination is based on whether the recipient is a member of the donor's medical staff, if the donor has a formal medical staff; (vi) the determination is based on the level of uncompensated care provided by the recipient; or (vii) the determination is made in any reasonable and verifiable manner that does not directly take into account the volume or value of referrals or other business generated between the parties. The arrangement is set forth in a written agreement that (i) is signed by the parties; (ii) specifies the items and services being provided, the donor's cost of the items and services, and the amount of the physician's contribution; and (iii) covers all of the electronic health records items and services to be provided by the donor. This requirement will be met if all separate agreements between the donor and the physician (and the donor and any family members of the physician) incorporate each other by reference or if they cross-reference a master list of agreements that is maintained and updated centrally and is available for review by the Secretary of HHS upon request. The master list should be maintained in a manner that preserves the historical The arrangement is set forth in a written agreement that (i) is signed by the parties; (ii) specifies the items and services being provided, the donor's cost of those items and services, and the amount of the recipient's contribution; and (iii) covers all of the electronic health records items and services to be provided by the donor (or any affiliate). This requirement will be met if all separate agreements between the donor (and affiliated parties) and the recipient incorporate each other by reference or if they cross-reference a master list of agreements that is maintained and updated centrally and is available for review by the Secretary of HHS upon request. The master list should be maintained in a manner that preserves the historical record of agreements. record of agreements. The donor does not have actual knowledge of, and does not act in reckless disregard or deliberate ignorance of, the fact that the physician possesses or has obtained items or services equivalent to those provided by the donor. For items or services that are of the type that can be used for any patient without regard to payor status, the donor does not restrict, or take any action to limit, the physician's right or The donor does not have actual knowledge of, and does not act in reckless disregard or deliberate ignorance of, the fact that the recipient possesses or has obtained items or services equivalent to those provided by the donor. For items or services that are of the type that can be used for any patient without regard to payor status, the donor does not restrict, or take any action to limit, the recipient's right or

ability to use the items or services for any patient. The items and services do not include staffing of physician offices and are not used primarily to conduct personal business or business unrelated to the physician's medical practice. The electronic health records software contains electronic prescribing capability, either through an electronic prescribing component or the ability to interface with the physician's existing electronic prescribing system that meets the applicable standards under Medicare Part D at the time the items and services are provided. ability to use the items or services for any patient. The items and services do not include staffing of the recipient's office and are not used primarily to conduct personal business or business unrelated to the recipient's clinical practice or clinical operations. The electronic health records software contains electronic prescribing capability, either through an electronic prescribing component or the ability to interface with the recipient's existing electronic prescribing system, that meets the applicable standards under Medicare Part D at the time the items and services are provided. The arrangement does not violate the anti-kickback statute or any Federal or State law or regulation governing billing or claims submission. The donor does not shift the costs of the items or services to any Federal health care program. The transfer of the items or services occurs and all conditions are satisfied on or before December 31, 2013. The transfer of the items and services occurs, and all conditions have been satisfied, on or before December 31, 2013.