Stark
Stark exception related to compensation arrangements for charitable donations

Anti-Kickback
[No comparable safe harbor]

The donations are bona fide charitable donations made by a physician (or immediate family member) to an entity.

The charitable donation is made to an organization exempt from taxation under the Internal Revenue Code (or to a supporting organization).

The donation is neither solicited, nor offered, in any manner that takes into account the volume or value of referrals or other business generated between the physician and the entity.

The donation arrangement does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission.

Stark
Stark exception related to compensation arrangements for professional courtesies

Anti-Kickback
[No comparable safe harbor]

Professional courtesy that is offered by an entity with a formal medical staff to a physician or a physician's immediate family member or office staff.

The professional courtesy is offered to all physicians on the entity's bona fide medical staff or in such entity's local community or service area without regard to the volume or value of referrals or other business generated between the parties.

The health care items and services provided are of a type routinely provided by the entity.

The entity has a professional courtesy policy that is set out in writing and approved in advance by the entity's governing body.

The professional courtesy is not offered to a physician (or immediate family member) who is a Federal health care program beneficiary, unless there has been a good faith showing of financial need.

The arrangement does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission.

Stark
Stark exception related to compensation arrangements for health information systems

Anti-Kickback
[No comparable safe harbor]

Items or services of information technology are provided by an entity to a physician to allow access to, and sharing of, electronic health care records and any complementary drug information systems, general health information, medical alerts, and related information for patients served by community providers and practitioners, in order to enhance the community's overall health.

The items or services are available as necessary to enable the physician to participate in a community-wide health information system, are principally used by the physician as part of the community-wide health information system, and are not provided to the physician in any manner that takes into account the volume or value of referrals or other business generated by the physician.

The community-wide health information systems are available to all providers, practitioners, and residents of the community who desire to participate.

The arrangement does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission.

Stark
Stark exception related to compensation arrangements for retention payments in underserved areas

Anti-Kickback
[No comparable safe harbor]

Remuneration is provided by a hospital directly to a physician on the hospital's medical staff to retain the physician's medical practice in the geographic area served by the hospital.

The physician has a bona fide firm, written recruitment offer or offer of employment from a hospital, academic medical center or physician organization that is not related to the hospital making the payment, and the offer specifies the remuneration being offered and requires the physician to move the location of his or her medical practice at least 25 miles and outside of the geographic area served by the hospital making the retention payment.

In lieu of a bona fide written offer, the physician furnishes to the hospital before the retention payment is made a written certification that the physician has a bona fide opportunity for future employment by a hospital, academic medical center or physician organization that requires the physician to move the location of his or her medical practice at least 25 miles and outside the geographic area served by the hospital and the certification contains at least the following-- (A) Details regarding the steps taken by the physician to effectuate the employment opportunity; (B) Details of the physician's employment opportunity, including the identity and location of the physician's future employer or employment location or both, and the anticipated income and benefits (or a range for income and benefits); (C) A certification that the future employer is not related to the hospital making the payment; (D) The date on which the physician anticipates relocating his or medical practice outside of the geographic area served by the hospital; and (E) Information sufficient for the hospital to verify the information included in the written certification; and the hospital takes reasonable steps to verify that the physician has a bona fide opportunity for future employment that requires the physician to relocate outside the geographic area served by the hospital.

All requirements of the Stark exception for physician recruitment are met.

Any retention payment is subject to the same obligations and restrictions, if any, on repayment or forgiveness of indebtedness as the written recruitment offer or offer of employment. This requirement does not apply in the case of a certification of employment.

In the case of a bona fide written offer, the retention payment does not exceed the lower of-- (A) The amount obtained by subtracting the physician's current income from physician and related services from the income the physician would receive from comparable physician and related services in the written recruitment or employment offer, provided that the respective incomes are determined using a reasonable and consistent methodology, and that they are calculated uniformly over no more than a 24-month period; or (B) The reasonable costs the hospital would otherwise have to expend to recruit a new physician to the geographic area served by the hospital to join the medical staff of the hospital to replace the retained physician.

In the case of a certification of employment, the retention payment does not exceed the lower of-- (A) An amount equal to 25 percent of the physician's current income (measured over no more than a 24-month period), using a reasonable and consistent methodology that is calculated uniformly; or (B) The reasonable costs the hospital would otherwise have to expend to recruit a new physician to the geographic area served by the hospital to join the medical staff of the hospital to replace the retained physician.

The physician's current medical practice is located in a rural area or HPSA (regardless of the physician's specialty) or is located in an area with demonstrated need for the physician as determined by the Secretary of HHS in an advisory opinion; or (B) At least 75 percent of the physician's patients reside in a medically underserved area or are members of a medically underserved population.

The hospital does not enter into a retention arrangement with a particular referring physician more frequently than once every 5 years.

The amount and terms of the retention payment are not altered during the term of the arrangement in any manner that takes into account the volume or value of referrals or other business generated by the physician.

The arrangement does not violate the anti-kickback statute or any federal or state law or regulation governing billing or claims submission.

The above requirements apply to remuneration provided by a federally qualified health center or a rural health clinic in the same manner as it applies to remuneration provided by a hospital.

Stark
Stark exception related to both ownership/investment and compensation for intra-family referrals in rural areas

Anti-Kickback
[No comparable safe harbor]

Services are provided pursuant to a referral from a referring physician to his or her immediate family member or to an entity furnishing designated health services with which the immediate family member has a financial relationship.

The patient who is referred resides in a rural area.

No other person or entity is available to furnish the services in a timely manner in light of the patient's condition within 25 miles of the patient's residence; except in the case of services furnished to patients where they reside (for example, home health services or in-home DME), no other person or entity is available to furnish the services in a timely manner in light of the patient's condition.

The financial relationship does not violate the anti-kickback statute or any federal or atate law or regulation governing billing or claims submission

The referring physician or the immediate family member must make reasonable inquiries as to the availability of other persons or entities to furnish the designated health services. However, neither the referring physician nor the immediate family member has any obligation to inquire as to the availability of persons or entities located farther than 25 miles from the patient's residence.

Stark
Stark exception related to compensation arrangement for unrelated remuneration

Anti-Kickback
[No comparable safe harbor]

Remuneration provided by a hospital to a physician that does not relate, directly or indirectly, to the furnishing of designated health services. Remuneration relates to the furnishing of designated health services if it: a) is an item, service, or cost that could be allocated in whole or in part to Medicare or Medicaid under cost reporting principles; b)is furnished, directly or indirectly, explicitly or implicitly, in a selective, targeted, preferential, or conditioned manner to medical staff or other persons in a position to make or influence referrals; or c) otherwise takes into account the volume or value of referrals or other business generated by the referring physician.

The remuneration must be wholly unrelated to the furnishing of DHS and must not in any way take into account the volume or value of a physician's referrals.

Anti-Kickback
Safe harbor for payments and other transfers made to a Federally Qualified Health Center

The transfer is made pursuant to a contract, lease, grant, loan, or other agreement that-- (A) is set out in writing; (B) is signed by the parties; and (C) covers, and specifies the amount of, all goods, items, services, donations, or loans to be provided by the individual or entity to the FQHC.

The amount of goods, items, services, donations, or loans specified in the agreement may be a fixed sum, fixed percentage, or set forth by a fixed methodology.

The amount may not be conditioned on the volume or value of federal health care program business generated between the parties.

The goods, items, services, donations, or loans are medical or clinical in nature or relate directly to services provided by the FQHC as part of the scope of the FQHC section 330 grant (including, by way of example, billing services, administrative support services, technology support, and enabling services, such as case management, transportation, and translation services, that are within the scope of the grant).

The FQHC reasonably expects the arrangement to contribute meaningfully to theFQHC's ability to maintain or increase the availability, or enhance the quality, of services provided to a medically underserved population served by the FQHC, and the FQHC documents the basis for the reasonable expectation prior to entering the arrangement. The documentation must be made available to the Secretary upon request. At reasonable intervals, but at least annually, the FQHC must re-evaluate the arrangement to ensure that the arrangement is expected to continue to satisfy the standards, and must document the re-evaluation contemporaneously. The documentation must be made available to the Secretary upon request. Arrangements must not be renewed or renegotiated unless the FQHC reasonably expects the standard to be satisfied in the next agreement term. Renewed or renegotiated agreements must comply with the requirements of this paragraph.

The individual or entity making the payment or transfer does not (i) require the FQHC (or its affiliated health care professionals) to refer patients to a particular individual or entity, or (ii) restrict the FQHC (or its affiliated health care professionals) from referring patients to any individual or entity.

Individuals and entities that offer to furnish goods, items, or services without charge or at a reduced charge to the FQHC must furnish such goods, items, or services to all patients from the FQHC who clinically qualify for the goods, items, or services, regardless of the patient's payor status or ability to pay. The individual or entity may impose reasonable limits on the aggregate volume or value of the goods, items, or services furnished under the arrangement with the FQHC, provided such limits do not take into account a patient's payor status or ability to pay.

The agreement must not restrict the FQHC's ability, if it chooses, to enter into agreements with other providers or suppliers of comparable goods, items, or services, or with other lenders or donors. Where a FQHC has multiple individuals or entities willing to offer comparable remuneration, the FQHC must employ a reasonable methodology to determine which individuals or entities to select and must document its determination.

The FQHC must provide effective notification to patients of their freedom to choose any willing provider or supplier. In addition, the FQHC must disclose the existence and nature of an agreement to any patient who inquires. The FQHC must provide such notification or disclosure in a timely fashion and in a manner reasonably calculated to be effective and understood by the patient.

The FQHC may, at its option, elect to require that an individual or entity charge a referred FQHC patient the same rate it charges other similarly situated patients not referred by the FQHC or that the individual or entity charge a referred FQHC patient a reduced rate (where the discount applies to the total charge and not just to the cost-sharing portion owed by an insured patient).