1. Background (page 12)
   1. Legislative and Regulatory History (page 12)
      1. Section 1877 of the Act (page 12)
      2. Section 1903(s) of the Act (page 14)
   2. Regulations History (page 15)      
      1. Regulations Published by HCFA and the Office of the Inspector General (OIG) Relating to Section 1877 of the Act (page 15)
      2. Details about Prior Related Regulations (page 17)

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2. Development of Phase I of this Final Rulemaking (page 23)
   1. Technical Explanation of Bifurcation of the Regulation (page 32)
   2. General Comments Regarding the January 1998 Proposed Rule and Responses (page 15)
3. General Prohibition Under Section 1877 of the Act (page 48)
   1. When Is There a Financial Relationship Between the Physician and the Entity? (page 52)
   2. When Does a Physician Make a Referral? (page 92)
      1. "Referral"(page 96)
      2. "Consultation" (page 106)

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4. Physician Compensation Under Section 1877 of the Act: An Overview (page 121)
5. "Volume or Value" of Referrals and "Other Business Generated" Standards: An Overview (page 126)

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6. Exceptions Applicable to Ownership and Compensation Arrangements (Section 1877(b) of the Act) (page 143)
   1. Physician Services (Section 1877(b)(1) of the Act) (page 143)
   2. In-office Ancillary Services (Section 1877(b)(2) of the Act) (page 153)
      1. Scope of Designated Health Services That Can Be In-office Ancillary Services (page 158)
      2. Direct Supervision (page 179)
      3. The Building Requirements (page 194)
      4. The Billing Requirement (page 229)

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   3. Group Practice Definition (Section 1877(h)(4) of the Act) (page 236)
      1. General Comments (page 245)
      2. Single Legal Entity Requirement (page 249)
      3. Members of the Group (page 268)
      4. The "Full Range of Services Test" (page 290)
      5. The "Substantially All Test"
      6. The "Seventy-five Percent Physician-Patient Encounters Test" (page 302)
      7. Unified Business Test (page 303)
      8. Profit Shares and Productivity Bonuses (page 317)
      9. Group Practice Attestations (page 333)

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   4. Prepaid Plans (Section 1877(b)(3) of the Act) (page 336)

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7. New Regulatory Exceptions (page 364)
   1. Academic Medical Centers (page 364)
   2. Fair Market Value (§411.357(l)) (page 376)
   3. Non-Monetary Compensation up to $300 (and Medical Staff Benefits (§§411.357(k) and (m)) (page 389)

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8. Definitions of the Designated Health Services (page 406)
   1. General Principles (page 406)
   2. General Comment: Professional Services as Designated Health Services (page 415)
   3. Clinical Laboratory Services (page 418)
   4. Physical Therapy Services (page 420)
   5. Occupational Therapy Services (page 429)
   6. Radiology and Certain Other Imaging Services (page 433)
   7. Radiation Therapy (page 456)
   8. Durable Medical Equipment (DME) (page 461)
   9. Parenteral and Enteral Nutrients, Equipment, and Supplies (page 466)
   10. Prosthetics, Orthotics, and Prosthetic Devices and Supplies (page 472)
   11. Home Health Services (page 487)
   12. Outpatient Prescription Drugs (page 493)
   13. Inpatient and Outpatient Services (page 511)

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   14. Other Definitions (page 528)
       1. Consultation (page 528)
       2. Entity (page 528)
       3. Fair Market Value (page 534)
       4. Group Practice (page 545)
       5. Health Professional Shortage Areas (page 545)
       6. Employee (page 546)
       7. Immediate Family Members (page 548)
       8. Referral (page 549)
       9. Remuneration and the Exceptions in Section 1877(h)(1)(C) of the Act (page 549)

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9. Collection of Information Requirements (page 566)

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10. Regulatory Impact Statement (page 570)
    1. Overall Impact (page 570)
    2. Anticipated Effects (page 572)
       1. Effects on Physicians (page 575)
       2. Effects on Other Providers (page 577)
       3. Effects on the Medicare and Medicaid Programs (page 578)
       4. Effects on Beneficiaries (page 579)
    3. Alternatives Considered (page 580)
    4. Conclusion (page 583)

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 Regulations Text (page 586)

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 Attachment (page 656)

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