Stark
Stark exception related to both ownership/investment and compensation

Anti-Kickback
[No comparable safe harbor

The preventive screening tests, immunizations, and vaccines must be covered by Medicare and must be listed as eligible for this exception on the List of CPT/HCPCS Codes.

The preventive screening tests, immunizations, and vaccines are subject to CMS-mandated frequency limits.

The arrangement for the provision of the preventive screening tests, immunizations, and vaccines does not violate the anti-kickback statute.

All billing and claims submission for the preventive screening tests, immunizations, and vaccines does not violate any federal or state law or regulation governing billing or claims submission.

Stark
Stark exception related to both ownership/investment and compensation

Anti-Kickback
[No comparable safe harbor]

The eyeglasses and contact lenses are covered by Medicare when furnished to patients following cataract surgery.

The eyeglasses or contact lenses are provided in accordance with the coverage and payment provisions set forth in Sec. 410.36(a)(2)(ii) and Sec. 414.228.

The arrangement for the furnishing of the eyeglasses or contact lenses does not violate the federal anti-kickback statute.

Billing and claims submission for the eyeglasses or contact lenses complies with all federal and state laws and regulations.

Stark
Stark exception related to both ownership/investment and compensation

Anti-Kickback
[No comparable safe harbor

The EPO and other dialysis-related drugs are furnished in or by an ESRD facility. " EPO and other dialysis-related drugs" means certain outpatient prescription drugs that are required for the efficacy of dialysis and identified as eligible for this exception on the List of CPT/HCPCS Codes; and "furnished" means that the EPO or dialysis-related drugs are administered to a patient in the ESRD facility, or, in the case of EPO or Aranesp (or equivalent drug identified on the List of CPT/HCPCS Codes) only, are dispensed by the ESRD facility for use at home.

The arrangement for the furnishing of the EPO and other dialysis-related drugs does not violate the anti-kickback statute.

All billing and claims submission for the EPO and other dialysis-related drugs does not violate any Federal or State law or regulation governing billing or claims submission.

This exception does not apply to any financial relationships between the referring physician and any entity other than the ESRD facility that furnishes the EPO and other dialysis-related drugs to the patient.

Stark
Stark exception related to both ownership/investment and compensation

Anti-Kickback
[No comparable safe harbor]

Implants are furnished by an ambulatory surgery center and include, but are not limited to, cochlear implants, intraocular lenses, and other implanted prosthetics, implanted prosthetic devices, and implanted DME.

The implant is implanted by the referring physician or a member of the referring physician's group practice in a Medicare-certified ASC with which the referring physician has a financial relationship.

The implant is implanted in the patient during a surgical procedure paid by Medicare to the ASC as an ASC procedure.

The arrangement for the furnishing of the implant does not violate the federal anti-kickback statute.

All billing and claims submission for the implants does not violate any federal or state law or regulation governing billing or claims submission.

This exception does not apply to any financial relationships between the referring physician and any entity other than the ASC in which the implant is furnished to, and implanted in, the patient.

Stark
Stark exception related to both ownership/investment and compensation for services provided by an academic medical center

Anti-Kickback
[No comparable safe harbor]

The referring physician a) is a bona fide employee of a component of the academic medical center on a full-time or substantial part-time basis. (A ``component'' of an academic medical center means an affiliated medical school, faculty practice plan, hospital, teaching facility, institution of higher education, departmental professional corporation, or nonprofit support organization whose primary purpose is supporting the teaching mission of the academic medical center. The components need not be separate legal entities); b) is licensed to practice medicine in the State(s) in which he or she practices medicine; c) has a bona fide faculty appointment at the affiliated medical school or at one or more of the educational programs at the accredited academic hospital; and d) provides either substantial academic services or substantial clinical teaching services (or a combination of academic services and clinical teaching services) for which the faculty member receives compensation as part of his or her employment relationship with the academic medical center. Parties should use a reasonable and consistent method for calculating a physician's academic services and clinical teaching services. A physician will be deemed to meet this requirement if he or she spends at least 20 percent of his or her professional time or 8 hours per week providing academic services or clinical teaching services (or a combination of academic services or clinical teaching services). A physician who does not spend at least 20 percent of his or her professional time or 8 hours per week providing academic services or clinical teaching services (or a combination of academic services or clinical teaching services) is not precluded from qualifying.

The total compensation paid by all academic medical center components to the referring physician is set in advance and, in the aggregate, does not exceed fair market value for the services provided, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated by the referring physician within the academic medical center.

All transfers of money between components of the academic medical center must directly or indirectly support the missions of teaching, indigent care, research, or community service.

The relationship of the components of the academic medical center must be set forth in written agreement(s) or other written document(s) that have been adopted by the governing body of each component. If the academic medical center is one legal entity, this requirement will be satisfied if transfers of funds between components of the academic medical center are reflected in the routine financial reports covering the components.

All money paid to a referring physician for research must be used solely to support bona fide research or teaching and must be consistent with the terms and conditions of the grant.

The referring physician's compensation arrangement does not violate the anti-kickback statute, or any federal or state law or regulation governing billing or claims submission.

The "academic medical center" consists of: a) an accredited medical school (including a university, when appropriate) or an accredited academic hospital (as defined at Sec. 411.355(e)(3)); b) 0ne or more faculty practice plans affiliated with the medical school, the affiliated hospital(s), or the accredited academic hospital; and c) one or more affiliated hospital(s) in which a majority of the physicians on the medical staff consists of physicians who are faculty members and a majority of all hospital admissions are made by physicians who are faculty members.

A faculty member is a physician who is either on the faculty of the affiliated medical school or on the faculty of one or more of the educational programs at the accredited academic hospital. Faculty from any affiliated medical school or accredited academic hospital education program may be aggregated, and residents and non- physician professionals need not be counted. Any faculty member may be counted, including courtesy and volunteer faculty.

An accredited academic hospital means a hospital or a health system that sponsors four or more approved medical education programs.