The second phase of Stark self-referral regulations are finally final, and HHS has "simplified" physician deals by issuing another hundred pages of regulations. The March 26, 2004, rulemaking is a behemoth of new exceptions, expansions of existing exceptions, and clarifications of the first phase of the regulation.
To understand what is required, you need to weave together 1998's proposed rules, 2001's first-phase rules, and HHS's new March 26, 2004, regulations. Or you need …
A Guide to Complying With Stark Self-Referral Rules, a service for physicians and medical group managers, hospital and health systems executives, health plan managers, and providers of 11 different "designated health services."
Written by a team of experienced health care attorneys from the law firm of McDermott Will & Emery LLP, this valuable service features:
- Easy-to-follow explanations of the prohibitions and exceptions
- Chapters devoted to the special Stark interests of different stakeholders (e.g., medical groups, hospitals, clinical labs, health plans, etc.)
- Summaries of all Stark Advisory Opinions issued by the OIG
- Copies of regulations (which are cited throughout) and other formal documents
The comprehensive how-to-do-it looseleaf guide also includes quarterly updates (and news summaries) for one year.
Stark rules are extremely complex, apply to a wide range of business deals, and have numerous gray areas that require you to put together the pieces of a complicated 10-year-old puzzle.
When you subscribe to A Guide to Complying With Stark Physician Self-Referral Rules, our team of legal experts will help you identify:
- Compensation and investment deals that meet HHS exceptions
- Business arrangements that will put you at risk if continued
- The types of deals that will require further HHS clarification
Stark is enforced by HHS's Office of Inspector General, one of health care's more aggressive watchdog agencies. With its substantial civil penalties — including Medicare and Medicaid exclusion — Stark presents very serious economic and professional exposure for those who fail to comply. A Guide to Complying With Stark Physician Self-Referral Rules is the best resource there is for making sure your contracts and business deals won't get you into legal trouble.
Table of Contents
Chapter 1: Introduction To The Physician Self-Referral Prohibition
- Environmental Factors Stimulating Self-Referral Growth
- Early Legislative Responses to the Growth of Self-Referrals
- Stark I—The Laboratory Ownership Prohibition
- Additional Challenges to Self-Referrals
- Stark II—The Broad Scale Prohibition against Self-Referrals
Chapter 2: The General Prohibition on Self-Referrals and Associated Billing and Payment
- The Scope of the Ban on Self-Referrals
- Key Terms
Chapter 3: Designated Health Services
- The Scope of Services Considered Designated Health Services
Chapter 4: The Stark Law Exceptions
- General Exceptions
- Ownership and Investment Exceptions—Permissible Investments
- Permitted Compensation Arrangements
- The 'Innocent Entity' Exceptions and Related State of Mind Issues
Chapter 5: Reporting, Compliance and Enforcement
- Reporting Requirements and Document Retention
- Advisory Opinions
- Sanctions for Violations of the Stark Law Prohibitions
- Internal Investigations and Voluntary Disclosure
- The False Claims Act and Qui Tam Actions
Chapter 6: Hospital-Physician Arrangements
- Equity Investment by a Physician in a Hospital
- Personal Service Arrangements
- Rental Arrangements
- Physician Recruitment Arrangements
- Physician Retention Arrangements
- Other Possible Compensation Arrangements
Chapter 7: Special Issues Affecting Physician Compensation
Chapter 8: Special Issues Affecting Medical Group Practices
- Qualification as a ‘Group Practice’ under the Stark Law
- Unique Exceptions Available Only in the Group Practice Context
Chapter 9: Special Issues Affecting Other Health Care Entities
- Specialty Hospitals
- Academic Medical Centers
- Ambulatory Surgery Centers
- Rural Health Care Providers
- Clinical Laboratories
- End-Stage Renal Disease
- Outpatient Rehabilitation Services
- The Stark Law and Medical Imaging
- Medical and Radiation Oncology Arrangements
- Pharmaceutical and Medical Device Industries
Appendicies
- Statutory Language
- Regulatory Language
- Preambles to the Regulations
- Advisory Opinions and Other Guidance
- CMS Guidance
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