Code of Federal Regulations Title 42. Public Health § 42.512.110 Definitions

For purposes of this part, the following terms are defined as follows unless otherwise stated:

Beneficiary means an individual who is enrolled in Medicare FFS.

Change in control means any of the following:

(1) The acquisition by any “person” (as this term is used in sections 13(d) and 14(d) of the Securities Exchange Act of 1934) of beneficial ownership (within the meaning of Rule 13d–3 promulgated under the Securities Exchange Act of 1934), directly or indirectly, of voting securities of the model participant representing more than 50 percent of the model participant's outstanding voting securities or rights to acquire such securities.

(2) The acquisition of the model participant by any individual or entity.

(3) The sale, lease, exchange or other transfer (in one transaction or a series of transactions) of all or substantially all of the assets of the model participant.

(4) The approval and completion of a plan of liquidation of the model participant, or an agreement for the sale or liquidation of the model participant.

Covered services means the scope of health care benefits described in sections 1812 and 1832 of the Act for which payment is available under Part A or Part B of Title XVIII of the Act.

Days means calendar days.

Descriptive model materials and activities means general audience materials such as brochures, advertisements, outreach events, letters to beneficiaries, web pages, mailings, social media, or other materials or activities distributed or conducted by or on behalf of the model participant or its downstream participants when used to educate, notify, or contact beneficiaries regarding the Innovation Center model. The following communications are not descriptive model materials and activities:  Communications that do not directly or indirectly reference the Innovation Center model (for example, information about care coordination generally);  information on specific medical conditions;  referrals for health care items and services;  and any other materials that are excepted from the definition of “marketing” as that term is defined at 45 CFR 164.501.

Downstream participant means an individual or entity that has entered into a written arrangement with a model participant under which the downstream participant engages in one or more Innovation Center model activities.

Innovation Center model means the RO Model implemented under subpart B or the ETC Model implemented under subpart C.

Innovation Center model activities means any activities impacting the care of model beneficiaries related to the test of the Innovation Center model under the terms of this part.

Medically necessary means reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body member.

Model beneficiary means a beneficiary attributed to a model participant or otherwise included in an Innovation Center model under the terms of this part.

Model participant means an individual or entity that is identified as a participant in the Innovation Center model under the terms of this part.

Model-specific payment means a payment made by CMS only to model participants, or a payment adjustment made only to payments made to model participants, under the terms of the Innovation Center model that is not applicable to any other providers or suppliers.

Provider means a “provider of services” as defined under section 1861(u) of the Act and codified in the definition of “provider” at § 400.202 of this chapter.

Supplier means a supplier as defined in section 1861(d) of the Act and codified at § 400.202 of this chapter.

U.S. Territories means American Samoa, the Federated States of Micronesia, Guam, the Marshall Islands, and the Commonwealth of the Northern Mariana Islands, Palau, Puerto Rico, U.S. Minor Outlying Islands, and the U.S. Virgin Islands.