1. Medical Device Industry Update Overview of the Stark Laws
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Medical Device Industry Update
Overview of the Stark Laws
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2. Purpose of Stark Laws
Hospital
Doctor
Device Company
The Stark Laws address consulting and professional relationships among doctors, hospitals and companies.
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3. Additional Information
The Stark Laws and the business relationships between doctors, hospitals and medical device providers are complex. Accordingly, appropriate legal counsel should be consulted for opinions on specific situations.
Interim Final Rule-Federal Register; Friday, March 26, 2004;16054 – 16146
Correction of Errors to Interim Final Rule-Federal Register; April 6, 2004; 17933
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4. Helpful Websites www.complianceland.com
(for fee web site)
Law firms with health care practices web sites frequently contain newsletters and/or other information.
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5. Stark Laws History Stark Law I
Enacted in 1989 and effective January 1, 1992
Self referral ban for clinical laboratory services
Prohibited entities from a making a claim for payment under the Medicare program for clinical laboratory services furnished pursuant to a prohibited referral.
Stark Law II
1993 expansion of Stark Law I, effective January 1, 1995
Expanded to cover additional health care services
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6. Stark Laws History Stark Law II, Phase II
Addresses comments received on phase I and provided final regulations
Interim Final Rule issued March 26, 2004
Effective July 26, 2004
Stark Law II, Phase III
Final rules required within three years of Phase II rules
Will address comments on Phase II
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7. Stark Laws Basic Prohibitions (A Physician Cannot)
Make a referral
To an entity
For the furnishing of “designated health services”
The may be payable by Medicare or Medicaid (or insurance companies in some states)
If the physician (or the immediate family member of the physician)
Has a direct or indirect financial relationship with the entity
Unless an exception to the Stark laws applies
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8. What Is A Referral?
A physician’s request for, ordering of, or certifying the need for, any “designated health service”…,
A physician’s request that includes the provision of any designated service, the establishment of a plan of care that includes the provision of a designated health service or the certifying or recertifying of the need for such a designated health service.
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9. Examples of Designated Health Services
Clinical laboratory services
Physical therapy, occupational therapy and speech language pathology
Radiology and certain other imaging services
Radiation therapy and supplies
Durable medical equipment and supplies
Prosthetics, orthotics and prosthetic devices and supplies
Home health services
Inpatient and outpatient hospital services
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10. What is a Direct or Indirect Financial Relationship?
A direct or indirect “ownership or investment interest” in the entity that furnishes designated health services
A “compensation arrangement” between the physician and the entity
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11. Requirements for “Personal Services Exemption”
Requirements for personal services exemption = provisions of an agreement with a physician that must be included.
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12. Requirements for “Personal Services Exemption
Cover all of the services to be furnished and be in writing, be signed by the parties to the agreement and specify the services covered by the agreement.
Cover all of the services to be furnished by the physician under the arrangement. If some services are covered in another agreement, the agreements must cross-reference each other or the entity furnishing the designated health service must maintain a master list of agreements.
Cover aggregate services that do not exceed those that are reasonable and necessary for the legitimate purposes of the arrangement.
(Requirements continued)
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13. Requirements for “Personal Services Exemption”-Continued
Be for a term of at least one year. If the agreement terminates before the end of the first year, the parties cannot enter into another arrangement for the substantially same services during the first year of the original term of the agreement.
Provide for compensation to be set in advance, does not exceed “fair market value,” and not be determined by the volume or value of any referrals or other business generated between the parties.
Not involve counseling or promotion of a business arrangement or other activity that violates any state or federal law, such as the federal Anti-kickback Statute.
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14. What is “Fair Market Value”
The value in arm’s length transactions, consistent with the general market value”.
General market value means “the compensation that would be included in a service agreement as the result of bona fide bargaining between well-informed parties to an agreement who are not otherwise in a position to generate business for the other party” at the time of the agreement.
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15. FMV of Hourly Payments
An hourly payment for personal services is considered to be “fair market value” if the payment is established using either of the following two methodologies:
The hourly rate is less than or equal to the average hourly rate for emergency room physician services in the relevant physician market, provided that there are at least three hospitals providing emergency room services in the market.
The hourly rate is determined by averaging the 50th percentile national compensation level for physicians with the same physician specialty in a survey divided by 2,000 hours.
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16. Physician Compensation Surveys
Sullivan, Cotter & Associates, Inc.-Physician Compensation and Productivity Survey-
Hay Group-Physician Salary Survey Report-
ECS Watson Wyatt-Hospital and Health Care Management Compensation Report-
William. M. Mercer-Integrated Health Networks Compensation Survey-
Hospital and Healthcare Compensation Services-Physician Salary Survey Report
Medical Group Management Association-Physician Compensation and Productivity Survey
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17. Stock Options and Stock Ownership
Options received as compensation are compensation-and not an ownership interest-until they are exercised.
The past granting of options is not a problem if the entire compensation arrangement fits within the exception applicable to personal service exemption.
Once the options become exercised, they become an ownership interest.
The only Stark exceptions for ownership are:
Publicly traded securities.
Mutual funds.
Certain providers (rural providers, a hospital in Puerto Rico, and a whole hospital-not a department or part thereof.
In-office ancillary services.
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18. FMV of a Stock Option Difference between FMV and exercise price.
Black-Scholes and similar methodologies are difficult to apply for nonpublic companies
Annual report footnote on accounting policies- Weighted average fair value of options granted during the year for employees=$.xx for 200x and 200x.
Annual report footnote on stock option plans-At December 31, 200x, the fair market value was less than the exercise price (of $.00) and, therefore, no compensation expense was recorded for options.
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19. Situations Where Stock Options Are a Problem
Physicians total compensation from the company, including the stock options, is not at fair market value.
Valuation does not take into consideration all relevant factors-for example, granting stock options if the Board has recently approved a plan to go public can affect the value of an option.
A physician whose hospital is a larger customer is granted stock options, while a physician whose hospital is a smaller customer does not receive stock options, even though the physicians perform the same consulting work for the company.
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20. Reporting Requirements
Information that can be requested (by CMS or OIG):
The name and identification of each physician who has a reportable financial relationship with the entity
The name and identification of each physician who has an immediate family member who has a reportable financial relationship
The covered services furnished by the entity
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21. Documentation Requirements
Entities and physicians relying upon the fair market value safe harbors for payment for a physician’s personal services should document compliance with the safe harbor.
Parties entering into personal service arrangements must be documenting all separate arrangements between the parties either by incorporation by reference or maintaining a master list of the contracts.
Parties that fall out of temporary compliance with and exception should document the reasons for the temporary non-compliance3 and the actions taken to rectify the situation
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22. Penalties Associated With Violations
Repayment of all amounts billed to the Medicare and Medicaid program that violate the Stark Law
Civil penalty of $15,000 for each claim submitted plus two times the reimbursement claimed
Monetary penalties up to $100,000 per scheme if an arrangement is found to have its principal purpose the intent to ensure physician referrals
Exclusion from the Medicare and Medicaid programs
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23. Penalties Associated with Violating the Federal Anti-kickback Statute
Civil penalties
Monetary penalty of $50,000 per violation
Assessment of up to three times the remuneration involved
Exclusion from participation in all Federal healthcare programs
Criminal violation
Five years in prison
Fine up to $25,000
Mandatory exclusion from participation in all federal health care programs
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24. Other Risks Liability under the U.S. False Claims Act
Liability under states “mini Stark Laws”, which prohibit self-referrals for reimbursements by any payer, not just the Medicare and Medicaid programs
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25. Tips On Complying Consult your legal counsel
Key company personnel should have an understanding of Stark Laws
Executive management should evaluate all business relationships with health care professionals
Company should adopt a Code of Ethics on interactions with health care professionals
Documentation policy should be established
Establish a program for monitoring compliance
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26. Disclaimers
The information in this presentation is believed to be correct but no assurances are provided that the information is correct.
Issues may exist that are significant that are not mentioned in this report.
This information is not intended to provide legal advice.
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