A Guide to Complying With Stark Physician Self-Referral Rules

Table of Contents

Introduction to the Physician Self-Referral Prohibition

The General Prohibition on Self-Referrals and Associated Billing and Payment

Designated Health Services (DHS)

• Clinical Laboratory Services
• Physical Therapy, Occupational Therapy, and Speech-Language Pathology Services
• Audiology Services
• Radiology and Other Imaging Services
• Radiation Therapy Services and Supplies
• Durable Medical Equipment and Supplies
• Parenteral and Enteral Nutrients, Equipment, and Supplies
• Prosthetics, Orthotics, and Prosthetic Devices and Supplies
• Home Health Services
• Outpatient Prescription Drugs
• Inpatient and Outpatient Hospital Services

Stark Law Exceptions

• General Exceptions
• Physician Services Exceptions
• In-Office Ancillary Services Exception
• Academic Medical Center Exception
• Other General Exceptions
• Permitted Ownership and Investment Interests
• Direct and Indirect Ownership Interests
• Equity-Based Compensation
• Exceptions
• Ownership or Investment in Retirement Plans
• Permitted Compensation Arrangements
• Direct and Indirect Compensation
• ‘Stand in the Shoes’ Concept
• ‘Fair Market Value’
• Asset Transaction or Service Agreement
• Rental Property
• Safe Harbor for Fair Market Hourly Compensation
• ‘Commercially Reasonable’
• ‘Volume or Value of Referrals’
• ‘Other Business Generated’
• ‘Set-in-Advance’ Requirement
• Signature Requirements
• Conditioning Compensation on Referrals
• Compensation Exceptions
• Leasing of Space and Equipment
• Bona Fide Employment Relationships
• Personal Services Arrangements
• Physician Recruitment and Retention
• Isolated Transactions
• Remuneration Unrelated to the Provision of DHS
• Group Practice Arrangements with a Hospital
• Payments by a Physician for Items and Services
• Charitable Donations by a Physician
• Non-Monetary Compensation Up to $300
• Medical Staff Incidental Benefits
• Fair Market Value Compensation
• Risk-Sharing Arrangements
• Compliance Training
• Indirect Compensation Exception
• Referral Service Arrangements
• Obstetrical Malpractice Subsidies
• Professional Courtesy
• Community-Wide Health Information Systems
• Donations of Technology and Training Services
• Electronic Prescribing Exception
• Electronic Health Records Exception
• ‘Innocent Entity’ Exceptions and Related State-of-Mind Issues

Reporting, Compliance and Enforcement

• Reporting Requirements and Document Retention
• Advisory Opinions
• Sanctions for Violations of the Stark Law Prohibitions
• Payment Penalties
• Improper Claims
• Circumvention Schemes
• Civil Money Penalty Proceedings
• Settlements; Recovery of Penalties; Notifications
• Internal Investigations and Voluntary Disclosure
• Protocols for Self-Disclosure
• The False Claims Act and Qui Tam Actions
• Elements of a Violation
• Damages
• Theories of Liability and Recovery
• Settlements

Special Issues Affecting Hospital-Physician Arrangements

• Equity Investment by a Physician in a Hospital
• Personal Service Arrangements
• Employment Arrangements between a Physician and a Hospital
• Rental Arrangements
• Physician Recruitment and Retention Arrangements
• Use of ‘Under Arrangements’ Agreements
• Indirect Compensation Arrangements
• Gainsharing

Special Issues Affecting Physician Compensation

Special Issues Affecting Medical Group Practices

• Qualification as a ‘Group Practice’
• Unique Exceptions

Special Issues Affecting Other Health Care Entities

• Physician-Owned and Specialty Hospitals
• PPACA Requirements
• Disclosure Requirements
• Academic Medical Centers
• Exceptions
• Faculty Compensation Arrangements
• AMC Relationships with Third Parties
• Ambulatory Surgery Centers
• Services Reimbursed Outside the Composite Rate
• ASC-Specific Exceptions
• Clinical Laboratories
• Equity Investment by a Physician
• Compensation Arrangements
• Other Payments
• End-Stage Renal Disease (ESRD) Facilities
• Services Reimbursed Outside the Composite Rate
• Physician Compensation Arrangements
• Physician Ownership of or Investment in ESRD Facilities
• ESRD Laboratory Arrangements
• Outpatient Rehabilitation Services
• Scope of Activities Constituting a Referral
• Key Exceptions
• Joint Ventures and Other Collaborative Arrangements
• Medical Imaging
• Medical and Radiation Oncology Arrangements
• Pharmaceutical and Medical Device Industries
• Managed Care Arrangements
• Health Plans and Managed Care Organizations As DHS Entities
• Prepaid Plan Exception
• Risk-Sharing Arrangements
• Physician Incentive Plans

Appendices

• Statutory Language
• Regulatory Language
• Preambles to the Regulations (on the CD only)
• Stark Law Advisory Opinions
• OIG Anti-Kickback Advisory Opinions
• Self-Disclosure Protocols and Other Guidance

Written By

A Guide to Complying With Stark Physician Self-Referral Rules is written by a team of experienced health care attorneys, and overseen by Francie Fernald, J.D., managing editor of AIS's diverse line of looseleaf services. Francie has decades of experience covering complex tax, business and financial matters, as well as other regulatory issues.

Written For

• Physicians and medical group managers
• Hospital and health systems executives
• Health plan managers
• Providers of designated health services
• Clinical labs
• PT
• Occupational therapy
• DME
• Home health
• Radiology
• Radiation therapy
• Parenteral & enteral
• Prosthetics & orthotics
• Outpatient Rx drugs
• Hospital services
• Attorneys and Consultants

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