Law Exceptions and Safe Harbors Price Reductions Offered to Health Plans [No comparable exception] Safe harbor for a reduction in price a contract health care provider offers to a health plan for the sole purpose of furnishing to enrollees items or services that are covered by the health plan, Medicare, or a State health care program There is a written agreement between the parties. If the health plan is a risk-based health maintenance organization, competitive medical plan, or prepaid health plan under contract with CMS or a State agency under a Federal statutory demonstration authority, or under other Federal statutory or regulatory authority, the contract health care provider must not claim payment in any form from the Department or the State agency for items or services furnished in accordance with the agreement except as approved by CMS or the State health care program, or otherwise shift the burden of such an agreement to the extent that increased payments are claimed from Medicare or a State health care program. If the health plan is a health maintenance organization, competitive medical plan, health care prepayment plan, prepaid health plan, or other health plan that has executed a contract or agreement with CMS or a State health care program to receive payment for enrollees on a reasonable cost or similar basis, the health plan and contract health care provider must comply with all of the following four standards: a) the term of the agreement between the health plan and the contract health care provider must be for not less than one year; b) the agreement between the health plan and the contract health care provider must specify in advance the covered items and services to be furnished to enrollees, and
the methodology for computing the payment to the contract health care provider; c) the health plan must fully and accurately report, on the applicable cost report or other claim form filed with the Department or the State health care program, the amount it has paid the contract health care provider under the agreement for the covered items and services furnished to enrollees; and d) the contract health care provider must not claim payment in any form from the Department or the State health care program for items or services furnished in accordance with the agreement except as approved by CMS or the State health care program, or otherwise shift the burden of such an agreement to the extent that increased payments are claimed from Medicare or a State health care program. If the health plan is not described in two paragraphs above and the contract health care provider is not paid on an at-risk, capitated basis, both the health plan and contract health care provider must comply with all of the following six standards: a) the term of the agreement between the health plan and the contract health care provider must be for not less than one year; b) the agreement between the health plan and the contract health care provider must specify in advance the covered items and services to be furnished to enrollees, which party is to file claims or requests for payment with Medicare or the State health care program for such items and services, and the schedule of fees the contract health care provider will charge for furnishing such items and services to enrollees; c) the fee schedule contained in the agreement between the health plan and the contract health care provider must remain in effect throughout the term of the agreement, unless a fee increase results directly from a payment update authorized by Medicare or the State health care program; d) the party submitting claims or requests for payment from Medicare or the State health care program for items and services furnished in accordance with the agreement must
not claim or request payment for amounts in excess of the fee schedule; e) the contract health care provider and the health plan must fully and accurately report on any cost report filed with Medicare or a State health care program the fee schedule amounts charged in accordance with the agreement and, upon request, will report to the Medicare or a State health care program the terms of the agreement and the amounts paid in accordance with the agreement; and f) the party to the agreement, which does not have the responsibility under the agreement for filing claims or requests for payment, must not claim or request payment in any form from the Department or the State health care program for items or services furnished in accordance with the agreement, or otherwise shift the burden of such an agreement to the extent that increased payments are claimed from Medicare or a State health care program. If the health plan is not described in the first two paragraphs above, and the contract health care provider is paid on an atrisk, capitated basis, both the health plan and contract health care provider must comply with all of the following five standards: a) the term of the agreement between the health plan and the contract health provider must be for not less than one year; b) the agreement between the health plan and the contract health provider must specify in advance the covered items and services to be furnished to enrollees and the total amount per enrollee (which may be expressed in a per month or other time period basis) the contract health care provider will be paid by the health plan for furnishing such items and services to enrollees and must set forth any copayments, if any, to be paid by enrollees to the contract health care provider for covered services; c) the payment amount contained in the agreement between the health care plan and the contract health care provider must remain in effect throughout the term of the agreement; d) the contract health care provider and the health plan must fully and
accurately report to the Medicare and State health care program upon request, the terms of the agreement and the amounts paid in accordance with the agreement; and e) the contract health care provider must not claim or request payment in any form from the Department, a State health care program or an enrollee (other than copayment amounts described in (b) and the health plan must not pay the contract care provider in excess of the amounts described in (b) for items and services covered by the agreement. Medical Staff Incidental Benefits exception to the referral prohibition related to [No comparable safe harbor] compensation arrangements from a hospital to a member of its medical staff The compensation is in the form of items or services (not including cash or cash equivalents) from a hospital to a member of its medical staff when the item or service is used on the hospital's campus. The compensation is provided to all members of the medical staff practicing in the same specialty (but not necessarily accepted by every member to whom it is offered) without regard to the volume or value of referrals or other business generated between the parties. Except with respect to identification of medical staff on a hospital Web site or in hospital advertising, the compensation is provided only during periods when the medical staff members are making rounds or are engaged in other services or activities that benefit the hospital or its patients. The compensation is provided by the hospital and used by the medical staff members only on the hospital's campus. Compensation, including, but not limited to, Internet access, pagers, or two-way radios, used away from the campus only to access hospital medical records or information or to
access patients or personnel who are on the hospital campus, as well as the identification of the medical staff on a hospital web site or in hospital advertising, will meet the "on campus" requirement. The compensation is reasonably related to the provision of, or designed to facilitate directly or indirectly the delivery of, medical services at the hospital. The compensation is of low value (that is, less than $25) with respect to each occurrence of the benefit (for example, each meal given to a physician while he or she is serving patients who are hospitalized must be of low value). The $25 limit in this paragraph (m)(5) will be adjusted each calendar year to the nearest whole dollar by the increase in the Consumer Price Index-Urban All Items (CPI-U) for the 12-month period ending the preceding September 30. CMS intends to display as soon as possible after September 30 each year both the increase in the CPI-U for the 12-month period and the new limits on the physician self- referral Web site. The compensation is not determined in any manner that takes into account the volume or value of referrals or other business generated between the parties. The compensation arrangement does not violate the antikickback statute or any federal or state law or regulation governing billing or claims submission. Other facilities and health care clinics (including, but not limited to, federally qualified health centers) that have bona fide medical staffs may provide compensation under this paragraph on the same terms and conditions applied to hospitals. Risk Sharing Arrangements [No comparable safe harbor] exception to the referral prohibition related to a compensation arrangement that is a risk- sharing arrangement (including, but not limited to, withholds,
bonuses, and risk pools) The arrangement is between a managed care organization or an independent physicians association and a physician (either directly or indirectly through a subcontractor) for services provided to enrollees of a health plan. The arrangement does not violate the federal anti-kickback statute or any law or regulation governing billing or claims submission. "Health plan" and "enrollees" have the meanings ascribed to those terms in the anti-kickback regulations. Compliance Training exception to the referral prohibition related to a [No comparable safe harbor] compensation arrangement for compliance training The training is provided by an entity to a physician (or to the physician's immediate family member or office staff) who practices in the entity's local community or service area. The training is held in the local community or service area. "Compliance training" means training regarding the basic elements of a compliance program (for example, establishing policies and procedures, training of staff, internal monitoring, or reporting); specific training regarding the requirements of Federal and State health care programs (for example, billing, coding, reasonable and necessary services, documentation, or unlawful referral arrangements); or training regarding other Federal, State, or local laws, regulations, or rules governing the conduct of the party for whom the training is provided. "Compliance training'' also includes programs that offer continuing medical education credit, provided that compliance training is the primary purpose of the program. Indirect Compensation Arrangements
exception to the referral prohibition related to a [No comparable safe harbor] compensation arrangement for indirect compensation arrangements The arrangement is an indirect compensation arrangement. The compensation received by the referring physician (or immediate family member) described in 411.354(c)(2)(ii) is fair market value for services and items actually provided and not determined in any manner that takes into account the volume or value of referrals or other business generated by the referring physician for the entity furnishing DHS. Compensation for the rental of office space or equipment may not be determined using a formula based on-- (A) A percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services performed or business generated in the office space or to the services performed or business generated through the use of the equipment; or (B) Per-unit of service rental charges, to the extent that such charges reflect services provided to patients referred between the parties. The indirect compensation arrangement is set out in writing, signed by the parties, and specifies the services covered by the arrangement, except in the case of a bona fide employment relationship between an employer and an employee, in which case the arrangement need not be set out in a written contract, but must be for identifiable services and be commercially reasonable even if no referrals are made to the employer. The compensation arrangement does not violate the antikickback statute or any laws or regulations governing billing or claims submission.