1. Legislative history of section 1877
2. Recent provisions and how they relate to each other
1. General prohibition
a. Referral, referring physician
b. Designated health services
c. Financial relationship
d. Compensation arrangement, remuneration
3. General Exceptions to the Prohibition on Physician Referrals
a. Exception-physician services
b. Exception-in-office ancillary services
c. Exception-certain prepaid health plans
d. Other exceptions
4. Exceptions That Apply Only to Certain Ownership or Investment Interests
a. Exception-certain investment securities and shares
b. Exception-ownership or investment interest in certain health care facilities
5. Exceptions That Apply Only to Certain Compensation Arrangements
a. Exception-rental of office space
b. Exception-rental of equipment
c. Exception-bona fide employment relationship
d. Exception-personal service arrangements
e. Exception-remuneration unrelated to the provision of designated health services
f. Exception-physician recruitment
g. Exception-isolated transaction
h. Exception-certain group practice arrangements with a hospital
i. Exception-payments by a physician for items and services
6. Requirements Related to the "Substantially All" Test
7. Reporting Requirements
9. Additional Definitions
a. "Clinical laboratory services"
e. "Immediate family member" or "member of a physician's immediate family"
g. "Plan of care"
10. Conforming Changes
11. Editorial Changes
1. Designated health services
a. Clinical laboratory services
b. Physical therapy services (including speech-language pathology services)
c. Occupational therapy services
d. Radiology services, including magnetic resonance imaging, computerized axial tomography scans, ultrasound services, and radiation therapy services and supplies
e. Durable medical equipment and supplies
f. Parenteral and enteral nutrients, equipment, and supplies
g. Prosthetics, orthotics, and prosthetic devices
h. Home health services
i. Outpatient prescription drugs
j. Inpatient hospital services
k. Outpatient hospital services
2. Direct supervision
4. Fair market value
5. Financial relationship
6. Group practice
1. Exception for physician services
2. Exception for in-office ancillary services
a. The site requirement
b. The billing requirement
c. Designated health services that do not trigger the in-office exception
3. Exception for services provided under prepaid health plans
a. Physicians, suppliers, and providers that contract with prepaid organizations
b. Managed care organizations under the Medicaid program
c. Evolving structures of integrated delivery and other health care delivery systems
d. Designated health services furnished under a demonstration project or waiver
1. Exception for ownership in publicly traded securities
2. Exception for hospital ownership
1. A new exception for all compensation arrangements that meet certain standards
2. A new exception for certain forms of "de minimis" compensation
3. The "volume or value of referrals" standard
4. The commercial reasonableness standard
5. The Secretary's authority to create additional requirements
6. Exception for bona fide employment relationships
7. Exception for personal services arrangements
8. Exception for remuneration unrelated to the provision of designated health services
9. Exception for a hospital's payments for physician recruitment
10. Exception for certain group practice arrangements with a hospital
11. Exception for payments by a physician for items and services
1. Which financial relationships must be reported
2. What entities outside the United States must report
1. Who qualifies as a "physician" for purposes of section 1903(s)
2. How the referral prohibition and sanctions affect Medicaid providers
3. How the referral rules apply when Medicaid-covered designated health services differ from the services covered under Medicare
4. How the reporting requirements apply under the Medicaid program
1. Compensation arrangement
What is an "indirect" compensation arrangement?
Which exceptions apply in indirect situations?
What are the characteristics of an "entity" that provides for the furnishing of designated health services?
When is an entity furnishing, or providing for the furnishing of, designated health services?
3. Financial relationship
How do equity and debt qualify as ownership?
Is membership in a nonprofit corporation an ownership or investment interest?
Do stock options and nonvested interests constitute ownership?
4. Group practice
What is the "full range of services" test?
5. Immediate family member or member of a physician's immediate family
How does the prohibition affect a physician's referrals to immediate family members?
If one member of a group practice cannot make a referral to an entity, are all other group practice physicians also precluded?
Do payments qualify as remuneration only if they result in a net benefit?
Does the prohibition apply only if a physician refers directly to a particular related entity?
When is the owner of a designated health services provider considered as equivalent to that provider?
Has a physician made a referral to a particular entity if another individual directs the patient there?
How will HCFA interpret situations in which it is not clear whether a physician has referred to a particular entity?
1. The in-office ancillary exception
Can a physician supply crutches as in-office ancillary services?
2. Exception for services furnished by organizations operating under prepaid plans.
Can a physician refer non-enrollees to a related prepaid organization or to its physicians and providers?
3. Other permissible exceptions for financial relationships that do not pose a risk of program or patient abuse.
Should situations that meet a safe harbor under the anti-kickback statute be automatically excepted?
1. Exception for ownership in publicly traded securities or mutual funds
Does the exception for publicly traded securities apply to stock options?
2. Exception for services provided by a hospital in which a physician or family member has an interest
Can a physician or family member own an interest in a chain of hospitals?
1. Compensation arrangements in general
Can a lease or arrangement for items or services have a termination clause?
Will a physician's referrals be prohibited if an entity pays for certain incidental benefits?
2. Exception for agreements involving the rental of office space or equipment
Can a lessee sublet office space or equipment?
Does the lease exception apply to any kind of lease covering space or equipment?
Can a lease provide for payment based on how often the equipment is used?
3. Exception for personal services arrangements
How does the physician incentive plan exception apply when an enrolling entity contracts with a group practice?
2. Entities, including hospitals