TABLE C
OVERLAPPING
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Description of |
Sources: 42 U.S.C. § 1320a-7b(b) and 42 C.F.R. § 1001.952 |
Stark General Exception Sources: 42 U.S.C. § 1395nn and 42 C.F.R. § 411.350 et seq. |
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1. Investment Interests in Specified Types of Entities 42 C.F.R. § 411.356(c) |
No specific safe harbor, but see safe harbor for Investment Interests in Small Entities (Item 1 in Table B) and Physician Investments in Their Own Practices (Item 2 in Table B). |
Returns
on investments in: A.
Hospitals located in B. Rural providers (as defined under the Social Security Act); or C. Hospitals located outside
of i. referring physician is authorized to perform services at the hospital; and ii. investment interest is in hospital itself and not subdivision. |
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2. Remuneration Unrelated to Provision of Designated Health Services 42 U.S.C. § 1395nn(b)(4)
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No safe harbor, but still defensible if remuneration was not willfully paid or received to induce referrals. |
Not defined by regulations and vague. |
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3. Isolated Transactions 42 C.F.R. § 411.357(f)
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No safe harbor except for Sale of Practice, but still defensible if remuneration was not willfully paid or received to induce referrals. |
All of the following three standards:
i. remuneration is not related to referrals, except for productivity bonus for services personally performed; ii. remuneration would be commercially reasonable even if no referrals; iii. no additional transactions between parties for six months except for other transactions excepted from Stark. |
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4. Payments by Physician 42 C.F.R. § 411.357(i) |
No safe harbor, but still defensible if remuneration was not willfully paid or received to induce referrals. |
A. To laboratory for clinical laboratory services; or B. To an entity as compensation for other items or services furnished at price consistent with fair market value. |
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5. Group Practice Arrangements With Hospitals In Effect Since 1989. 42 C.F.R. § 411.357(h) |
No safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals. |
Value received where group practice provides services but the hospital does billing pursuant to certain arrangements, provided such arrangements have been in effect without interruption since December 19, 1989. |
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6. Academic Medical Centers 42 C.F.R. § 411.355(e)
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No safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals. |
Services provided by an academic medical center if: i. the referring physician has a bona fide full- or substantial part-time employment relationship with a component of the medical center (e.g., an affiliated medical school, a teaching hospital, etc.); ii. the physician’s total compensation is set in advance, does not exceed fair market value or take into account the volume or value of referrals or other business generated, and does not violate the anti-kickback statute; and iii. the academic medical center meets certain conditions (relating to its composition and the relationships among its components). |
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7. Fair Market Value Compensation Exception 42 C.F.R. § 411.357(l)
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No specific safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals. |
Any commercially reasonable business transaction between a physician (or immediate family member) and an entity which furthers a legitimate business purpose if:
i. the agreement is in writing, signed by the parties, and covers identifiable items and services; ii. the agreement specifies the time frame, which can be for any period, provided the parties can only enter one agreement for the same item or services during the course of one year; iii. the agreement specifies the compensation that will be provided under the arrangement which has been set in advance, is consistent with fair market value, and does not take into account the volume or value of any referrals or other business generated by the referring physician; and iv. the agreement does not violate the anti-kickback statute. |
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8. Non-Monetary Compensation Up to $300 42 C.F.R. § 411.357(k)
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No specific safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals. |
Non-cash items of up $300 per year if: i. the compensation is not determined in a way that takes into account the volume or value of the physician’s referrals; ii. the compensation is not solicited by the physician; and iii. the compensation does not violate the anti-kickback statute. |
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9. Medical Staff Incidental Benefits 42 C.F.R. § 411.357(m)
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No specific safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals.
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Incidental benefits (e.g., free parking, discounted cafeteria meals, etc.) provided by hospitals to their medical staff if: i. they are offered to all members of the medical staff without regard to the volume or value of referrals; ii. they are used only on the hospital’s campus; iii. they are reasonably related to the delivery of medical care at the hospital; iv. they are consistent with what comparable hospitals offer; and v. they are of low value (less than $25) with respect to each occurrence of the benefit. |
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10. Compliance Training 42 C.F.R. § 411.357(o)
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No specific safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals. |
Training provided within the local community by a hospital to a physician regarding the basic elements of a compliance program or specific training regarding the requirements of federal health care programs (including billing, coding and documentation). |
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11. Indirect Compensation Arrangements 42 C.F.R. § 411.357(p) |
No specific safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals. |
Indirect compensation arrangements between physicians (or their immediate family members) and DHS providers to whom they refer if: i. the compensation received by the referring physician is fair market value and does not take into account the volume or value of any referrals or other business generated by the referring physician to the DHS provider; ii. the compensation arrangement is in writing, signed by the parties, and specifies the services covered by the arrangement; and iii. the compensation arrangement does not violate the anti-kickback statute or any laws or regulations governing billing or claims submission. |
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12. Preventive Screening Tests, Immunizations and Vaccines 42 C.F.R. § 411.355(h) |
No specific safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals. |
These services are excluded provided the arrangement does not violate the anti-kickback statute or any laws or regulations governing billing or claims submission. |
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13. Eyeglasses and Contact Lenses 42 C.F.R. § 411.355(i)
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No specific safe harbor, but still defensible if remuneration not willfully paid or received to induce referrals. |
These items are excluded provided the arrangement does not violate the anti-kickback statute or any laws or regulations governing billing or claims submission.
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NOTE: This site includes a summary of certain compliance issues facing
health care providers today. This site does not, and is not intended to, give
legal advice. Reference should be made to full text of the statutes and
regulations for complete analysis. Consultation with competent counsel is
strongly recommended.