The Stark II Regulations

I.

INTRODUCTION

A.

Overview

B.

Statutory and Regulatory History

C.

Effective Dates

D.

Comment Period on "Phase II Rule"

E.

Major Changes in Final Phase I Rule

II.

THE BASIC PROHIBITION

A.

Financial Relationship

B.

Covered Referrals for Designated Health Services

III.

GENERAL EXCEPTIONS PROTECTING OWNERSHIP, COMPENSATION OR BOTH

A.

Physician Services

B.

In-Office Ancillary Services

1.

The Performance Test.

2.

The Site-of-Service Test.

3.

The Billing Test.

4.

Enteral and Parenteral Nutrition and Durable Medical Equipment.

5.

Special Rules for Home Care Physicians.

C.

Prepaid Health Plans

D.

Services Paid Under a Composite Rate

E.

Academic Medical Centers

F.

Implants in an ASC

G.

EPO and Other Drugs Furnished in or by an ESRD Facility.

H.

Preventive Screening Tests, Immunizations, and Vaccines

I.

Eyeglasses and Contact Lenses

IV.

BONA FIDE GROUP PRACTICES FOR PURPOSES OF STARK

A.

Single Legal Entity

B.

Two Physician Test

C.

Full Range of Services Test

D.

Substantially All Services Test

E.

Distribution of Income and Expenses

F.

Unified Business Test

G.

Compensation Test

H.

Patient Encounters Test

V.

COMPENSATION EXCEPTIONS INCLUDED IN THE PHASE I FINAL RULE

A.

Non-Monetary Compensation up to $300

B.

Fair Market Value Compensation

C.

Medical Staff Incidental Benefits

D.

Risk Sharing Arrangements

E.

Compliance Training

F.

Indirect Compensation

VI.

OTHER KEY DEFINITIONS

A.

1.

Clinical Laboratory Services.

2.

Durable Medical Equipment.

3.

Home Health Services.

4.

Inpatient and Outpatient Hospital Services.

5.

Outpatient Prescription Drugs.

6.

Parenteral and Enteral ("P&E") Nutrients, Equipment and Supplies.

7.

Physical Therapy, Occupational Therapy and Speech-Language Pathology Services.

8.

Prosthetics, Orthotics and Prosethetic Devices and Supplies.

9.

Radiation Therapy Services and Supplies.

10.

Radiology and Certain Other Imaging Services.

B.

1.

Consultation.

2.

Fair Market Value.

3.

Employee.

4.

Immediate Family Member.

5.

"Incident to".

6.

Patient Care Services.

7.

Referral and Referring Physician.

VII.

CERTIFICATION OF NEED FOR HOME HEALTH SERVICES