Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Warranties

Warranties – Current as of March 2021

Stark [No comparable exception]	Anti-Kickback Safe harbor for warranties 42 CFR 1001.952(g)
	Any payment or exchange of anything of value under a warranty provided by a manufacturer or supplier of one or more items and services (provided the warrant covers at least one item) to the buyer of the items and services
	The buyer (unless the buyer is a Federal health care program beneficiary) must fully and accurately report any price reduction of the item or service (including a free item or service), that was obtained as part of the warranty, in the applicable cost reporting mechanism or claim for payment filed with the Department or a State agency.
	The buyer must provide, upon request by the Secretary of HHS or a State agency, the information required to be provided by the manufacturer or supplier.
	The manufacturer or supplier must fully and accurately report the price reduction of the item or service (including a free item or service), that the buyer obtained as part of the warranty, on the invoice or statement submitted to the buyer, and inform the buyer of its obligations under the safe harbor; and/or where the amount of the price reduction is not known at the time of sale, the manufacturer or supplier must fully and accurately report the existence of a warranty on the invoice or statement, inform the buyer of its obligations, and, when the price reduction becomes known, provide the buyer with documentation of the calculation of the price reduction resulting from the warranty.
	The manufacturer or supplier must not pay any remuneration to any individual (other than a beneficiary) or entity for any medical, surgical, or hospital expense incurred by a beneficiary other than for the cost of the items and services subject to the warranty.
	If the manufacturer or supplier offers a warranty for more than one item or one or more items and related services, the federally reimbursable items and services subject to the warranty must be reimbursed by the same Federal health care program and in the same Federal health care program payment.
	The manufacturer or supplier must not condition a warranty on a buyer's exclusive use of, or a minimum purchase of, any of the manufacturer's or supplier's items or services.
	The term warranty means either a) any written affirmation of fact or written promise made in connection with the sale of an item or bundle of items, or services in combination with one or more related items, by a manufacturer or supplier to a buyer, which affirmation of fact or written promise relates to the nature of the quality of workmanship and affirms or promises that such quality or workmanship is defect free or will meet a specified level of performance over a specified period of time; b) Any undertaking in writing in connection with the sale by a manufacturer or supplier of an item or bundle of items, or services in combination with one or more related items, to refund, repair, replace, or take other remedial action with respect to such item or bundle of items in the event that such item or bundle of items, or services in combination with one or more related items, fails to meet the specifications set forth in the undertaking which written affirmation, promise, or undertaking becomes part of the basis of the bargain between a seller and a buyer for purposes other than resale of such item or bundle of items; or c) A manufacturer's or supplier's agreement to replace another manufacturer's or supplier's defective item or bundle of items (which is covered by an agreement made in accordance with this safe harbor, on terms equal to the agreement that it replaces.

Jump to Page