Includes changes from the 2009 Inpatient Prospective ... · Includes changes from the 2009 Inpatient Prospective Payment Final Rules published in Federal Register August 18, 2008

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

Stark

[No comparable exception; ambulatory surgery centers

exempt under Stark, not a designated health service]

Anti-Kickback

Safe harbor for payments on an investment interest in ASC

The entity is a certified ambulatory surgery center (ASC)

under the Medicare program.

The operating and recovery room space is dedicated

exclusively to the ASC.

Patients referred to the ASC by an investor are fully informed

of the investor's investment interest in the ASC.

The terms on which an investment interest is offered must

not be related to previous or expected volume of referrals,

services furnished, or the amount of business otherwise

generated from the investor to the ASC.

The ASC or any investor (or other individual or entity acting

on behalf of the entity or any investor) must not loan funds to

or guarantee a loan for an investor if the investor uses any

part of such loan to obtain the investment interest.

The amount of payment to an investor in return for the

investment must be directly proportional to the amount of the

capital investment (including the fair market value of any pre-

operational services rendered) of that investor.

All ancillary services for federal or state health care program

beneficiaries performed at the ASC must be directly and

integrally related to primary procedures performed at the

ASC, and none may be separately billed to a federal or state

health care program.

The ASC and any physician or surgeon or hospital investors

must treat patients receiving medical benefits or assistance

under any federal or state health care program in a

nondiscriminatory manner.

Ambulatory Surgery Centers: Hospital/Physician ASCs

Stark



Anti-Kickback

Safe harbor for payments on an investment interest in a

hospital/physician ambulatory surgery center

All requirements listed under "Ambulatory Surgery Centers:

All" are met.

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

Stark



Anti-Kickback


multi-specialty ambulatory surgery center


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

Stark



Anti-Kickback


single-specialty ambulatory surgery center


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


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

Stark



Anti-Kickback

Safe harbor for payments on an investment interest in an

surgeon-owned ambulatory surgery center


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


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

Stark

[No comparable exception]

Anti-Kickback

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

Stark

Stark exception to the referral prohibition related to

compensation arrangements for nominal non-monetary

compensation to physicians

Anti-Kickback

[No comparable safe harbor]

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

Stark

[No comparable exemption]

Anti-Kickback

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


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

Stark


Anti-Kickback

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

Stark


compensation arrangements for bona fide employment

relationships with physicians (or an immediate family member

of the physician)

Anti-Kickback

Safe harbor for employment relationships

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

Stark


compensation arrangements for fair market value

compensation

Anti-Kickback


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

Stark


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

Anti-Kickback


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

Stark


Anti-Kickback

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 wholly-

owned 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

Stark


compensation arrangements for incentive plans between an

entity and a physician

Anti-Kickback


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

Stark


Anti-Kickback

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 decision-

making, 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

Stark Anti-Kickback

[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

Stark


compensation arrangements for isolated financial

transactions with a physician, such as a one-time sale of

property or a practice

Anti-Kickback


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 Stark 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

Stark


compensation arrangements for rental of equipment between

Anti-Kickback

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

lease.

The lease agreement is set out in writing and signed by the

parties.

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

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 covers all of the equipment leased between the

parties for the term of the lease and specifies the equipment

covered by the lease.

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

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.

If the lease is intended to provide the lessee with use of the

equipment 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 interval.

The rental charges over the term of the agreement are set in

advance, are consistent with fair market value, and are not

determined— (i) In a manner that takes into account the


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) Per-

unit of service rental charges, to the extent that such charges

reflect services provided to patients referred between the

parties.

The term of the lease is for not less than one year.

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


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

Stark


compensation arrangements for rental of office space

between an entity and a referring physician

Anti-Kickback

Safe harbor for payments made by a lessee to a lessor for

the use of space

The agreement is set out in writing, is signed by the parties,

and specifies the premises it covers.

The lease agreement is set out in writing and signed by the

parties.

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

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 lease covers all of the premises leased between the

parties for the term of the lease and specifies the premises

covered by the lease.

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

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 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.

The rental charges over the term of the agreement are set in

advance and are consistent with fair market value.

The term of the lease is for not less than one year.

The rental charges over the term of the agreement are not

determined-- (i) In a manner that takes into account the


between the parties; or (ii) Using a formula based on— (A) A


otherwise attributable to the services performed or business

generated in the office space; or (B) Per-unit of service rental

charges, to the extent that such charges reflect services

provided to patients referred between the parties.

The aggregate rental charge is set in advance, is consistent

with fair market value in arms-length transactions and is not





program.

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


a State health care program.

Practitioner Recruitment

Stark


compensation arrangements for physician recruitment

Anti-Kickback

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 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 out in writing and signed by both

parties.

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 anti-

privileges 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


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


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

Stark


Anti-Kickback

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

Stark


Anti-Kickback

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

Stark


compensation arrangements for personal services or

management

Anti-Kickback

Safe harbor for remuneration from an entity under an

personal service arrangement or management contract

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

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 wholly-

owned 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 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 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

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 term of the agreement is for not less than one year.

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


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





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

State law.

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.

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

Stark


Anti-Kickback

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


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

Stark


compensation arrangements for referral services

Anti-Kickback

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 anti-

kickback 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

Stark


Anti-Kickback

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 at-

risk, 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

Stark


compensation arrangements from a hospital to a member of

its medical staff

Anti-Kickback


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 anti-

kickback statute or any federal or state law or regulation


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

Stark

Stark 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)

Anti-Kickback [No comparable safe harbor]

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

Stark


compensation arrangement for compliance training

Anti-Kickback


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

Stark


compensation arrangement for indirect compensation

Anti-Kickback


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


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 anti-

kickback statute or any laws or regulations governing billing

or claims submission.

Ambulance Restocking: All

Stark


Anti-Kickback

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

Stark


Anti-Kickback


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

Stark


Anti-Kickback



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

Stark


Anti-Kickback



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

Stark

Stark exception to the referral prohibition related to both

ownership/investment and compensation arrangements for

certain physician services

Anti-Kickback

[No comparable safe harbor

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

Stark


Anti-Kickback

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


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 cost-

sharing or premium amounts to the extent that increased

payments are claimed from Medicare or a State health care

program.

Obstetrical Malpractice Insurance Subsidies

Stark


compensation arrangements for obstetrical malpractice

insurance subsidiaries

Anti-Kickback

Safe harbor for obstetrical malpractice insurance subsidies

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 self-

funded 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 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 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 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

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.

There is no requirement that the practitioner make referrals

to, or otherwise generate business for, the entity as a

condition for receiving the benefits.

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

referrals may be restricted under an employment

arrangement or services contract).

The practitioner must treat obstetrical patients who receive

medical benefits or assistance under any Federal health care

program in a nondiscriminatory manner.

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 part-

time 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 part-

time 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

Stark


Anti-Kickback

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

Stark


Anti-Kickback

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.

Stark


Anti-Kickback

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

Stark


ownership or investment interests

Anti-Kickback

Safe harbor for certain 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

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.

With respect to an investment interest that is an equity

security, the equity security must be registered with the

Securities and Exchange Commission.

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.


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


services to, or otherwise generate business for the entity if

the investor uses any part of such loan to obtain the



investment interest must be directly proportional to the

amount of the capital investment of that investor.

Mutual Funds

Stark


ownership or investment interests for mutual funds

Anti-Kickback


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

Stark


Anti-Kickback


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.







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,


for the entity as a condition for remaining as an investor.



a cross referral agreement) to passive investors differently


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.










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

Stark


ownership or investment interests

Anti-Kickback


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

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.

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.

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.







investor who is in a position to make or influence referrals to,


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,


for the entity as a condition for remaining as an investor.



a cross-referral agreement) to passive investors differently


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.










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

Stark


ownership or investment interests for certain hospital

investments

Anti-Kickback


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

Stark

Stark exception related to both ownership/investment and

compensation

Anti-Kickback


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

Stark


compensation

Anti-Kickback


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

Stark


compensation

Anti-Kickback


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 dialysis-

related drugs to the patient.

Implants in an ASC

Stark


compensation

Anti-Kickback


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

Stark


compensation for services provided by an academic medical

center

Anti-Kickback


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

Stark


compensation

Anti-Kickback


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

Stark


compensation for in-house ancillary services

Anti-Kickback


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 anti-

kickback 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

Stark

Stark exception related to compensation arrangements for

charitable donations

Anti-Kickback


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

Stark Anti-Kickback


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


claims submission.

Community-Wide Health Information Systems

Stark


health information systems

Anti-Kickback


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.



claims submission.

Retention Payments in Underserved Areas

Stark


retention payments in underserved areas

Anti-Kickback


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 Stark 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.



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

Stark


compensation for intra-family referrals in rural areas

Anti-Kickback


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

Stark

Stark exception related to compensation arrangement for

unrelated remuneration

Anti-Kickback


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

Stark


Anti-Kickback

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

Stark

Stark exception related to compensation arrangements

Anti-Kickback

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.


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 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 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.

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


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.




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 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



parties.





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.



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






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.



that the recipient possesses or has obtained items or


Electronic Health Records Items and Services

Stark

Stark exception related to compensation arrangements

Anti-Kickback

Safe harbor for payments made for electronic health records


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.


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.

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.

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


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


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.

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 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 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.



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


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

Neither the eligibility of a recipient for the items or services,


determined in a manner that directly takes into account the


between the parties. For the purposes of this paragraph, the

determination is deemed not to directly take into account the


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


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


parties.



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








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.



that the physician possesses or has obtained items or




that the recipient possesses or has obtained items or







restrict, or take any action to limit, the recipient's right or

ability to use the items or services for any patient. 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 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 physician's

existing electronic prescribing system that meets the

applicable standards under Medicare Part D at the time the

items and services are provided.

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.


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.

Documents

Includes changes from the 2009 Inpatient Prospective ... · Includes changes from the 2009 Inpatient Prospective Payment Final Rules published in Federal Register August 18, 2008