Section 1200-06-03-.20 - ADVERTISING(1) Policy Statement. The lack of sophistication on the part of many in the health care community concerning medical laboratories, the importance of the interests affected by the choosing of a medical laboratory and the foreseeable consequences of unrestricted advertising by medical laboratories which is recognized to pose special possibilities for deception, require that special care be taken by medical laboratories to avoid misleading the health care community. Medical laboratories must be mindful that the benefits of advertising depend upon its reliability and accuracy. Since advertising by medical laboratories is calculated and not spontaneous, reasonable regulation designed to foster compliance with appropriate standards serves the public interest without impeding the flow of useful, meaningful, and relevant information to the health care community.(2) Definitions (a) Advertisement - Informational communication to the health care community in any manner designed to attract attention to the medical laboratories which are licensed to practice in Tennessee.(b) Licensee - Any entity holding a license to operate as a medical laboratory in the State of Tennessee. Where applicable this shall include partnerships and/or corporations.(c) Material Fact - Any fact which a health care provider would need to know or rely upon in order to make an informed decision concerning the choice of medical laboratories to serve its particular needs.(d) Bait and Switch Advertising - An alluring but insincere offer to sell a product or service which the advertiser in truth does not intend or want to sell. Its purpose is to switch consumers from buying the advertised service or merchandise, in order to sell something else, usually for a higher fee or on a basis more advantageous to the advertiser.(e) Discounted Fee - Shall mean a fee offered or charged by a medical laboratory or a product or service that is less than the fee the medical laboratory usually offers or charges for the product or service. Products or services expressly offered free of charge shall not be deemed to be offered at a "discounted fee."(f) Health Care Community - Shall mean hospitals, ambulatory surgical treatment centers, medical practices, individual physicians, and other health care providers with legal authority to order laboratory tests.(3) Advertising Fees and Services (a) Fixed Fees - Fixed fees may be advertised for any service. It is presumed unless otherwise stated in the advertisement that a fixed fee for a service shall include the cost of all professional recognized components within generally accepted standards that are required to complete the service.(b) Range of Fees. A range of fees may be advertised for services and the advertisement must disclose the factors used in determining the actual fee, necessary to prevent deception of the health care community.(c) Discount Fees. Discount fees may be advertised if: 1. The discount fee is in fact lower than the licensee's customary or usual fee charged for the service; and2. The licensee provides the same quality and components of service and material at the discounted fee that are normally provided at the regular, non-discounted fee for that service.(d) Related Services and Additional Fees. Related services which may be required in conjunction with the advertised services for which additional fees will be charged must be identified as such in any advertisement.(e) Time Period of Advertised Fees. 1. Advertised fees shall be honored for those seeking the advertised services during the entire time period stated in the advertisement whether or not the services are actually rendered or completed within that time.2. If no time period is stated in the advertisement of fees, the advertised fee shall be honored for thirty (30) days from the last date of publication or until the next scheduled publication whichever is later whether or not the services are actually rendered or completed within that time.(4) Advertising Content. The following acts or omissions in the context of advertisement by any licensee shall constitute unethical conduct, and subject the licensee to disciplinary action pursuant to T.C.A. § 68-29-127(9) and (10). (a) Claims that the services performed, personnel employed, materials or office equipment used are professionally superior to that which is ordinarily performed, employed, or used, or that convey the message that one licensee is better than another when superiority of services, personnel, materials or equipment cannot be substantiated.(b) The misleading use of an unearned or non-health degree in any advertisement.(c) Promotion of professional services which the licensee knows or should know is beyond the licensee's ability to perform.(d) Techniques of communication which intimidate, exert undue pressure or undue influence over a prospective client.(e) Any appeals to an individual's anxiety in an excessive or unfair manner.(f) The use of any personal testimonial attesting to a quality of competency of a service or treatment offered by a licensee that is not reasonably verifiable.(g) Utilization of any statistical data or other information based on past performances for prediction of future services, which creates an unjustified expectation about results that the licensee can achieve.(h) The communication of personal identifiable facts, data, or information about a patient without first obtaining patient consent.(i) Any misrepresentation of a material fact.(j) The knowing suppression, omission or concealment of any materials fact or law without which the advertisement would be deceptive or misleading.(k) Statements concerning the benefits or other attributes of medical procedures or products that involve significant risks without including: 1. A realistic assessment of the safety and efficiency of those procedures or products; and2. The availability of alternatives; and3. Where necessary to avoid deception, descriptions or assessment of the benefits or other attributes of those alternatives.(l) Any communication which creates an unjustified expectation concerning the potential results of any laboratory test.(m) Failure to comply with the rules governing advertisement of fees and services, or advertising records.(n) The use of "bait and switch" advertisements. Where the circumstances indicate "bait and switch" advertising, the Board may require the licensee to furnish data or other evidence pertaining to those sales at the advertised fee as well as other sales.(o) Misrepresentation of a licensee's credentials, training, experience, or ability.(p) Failure to include the corporation, partnership or individual licensee's name, address, and telephone number in any advertisement. Any corporation, partnership or association which advertises by use of a trade name or otherwise fails to list all licensed laboratory personnel practicing at a particular location shall: 1. Upon request provide a list of all licensed laboratory personnel practicing at that location; and2. Maintain and conspicuously display at the licensee's office, a directory listing all licensed laboratory personnel practicing at that location.(q) Failure to disclose the fact of giving compensation or anything of value to representatives of the press, radio, television or other communicative medium in anticipation of or in return for any advertisement (for example, newspaper article) unless the nature, format or medium of such advertisement make the fact of compensation apparent.(r) After thirty (30) days of the licensee's departure, the use of the name of any licensed laboratory personnel formerly practicing at or associated with any advertised location or on office signs or buildings. This rule shall not apply in the case of a retired or deceased former associate who practiced in association with one or more of the present licensees if the status of the former associate is disclosed in any advertisement or sign.(s) Stating or implying that a certain licensee provides all services when any such services are performed by another licensee.(5) Advertising Records and Responsibility (a) Each licensee who is a principal partner, or officer of a firm or entity identified in any advertisement, is jointly and severally responsible for the form and content of any advertisement. This provision shall also include any licensed professional employees acting as an agent of such firm or entity.(b) Any and all advertisement are presumed to have been approved by the licensee named therein.(c) A recording of every advertisement communicated by electronic media, and a copy of every advertisement communicated by print media, and a copy of any other form of advertisement shall be retained by the licensee for a period of two (2) years from the last date of broadcast or publication and be made available for review upon request by the Board or its designee.(d) At the time any type of advertisement is placed, the licensee must possess and rely upon information which, when produced, would substantiate the truthfulness of any assertion, omission or representation of material fact set forth in the advertisement or public information.(6) Use of Titles in Advertisements. Any medical laboratory licensed by the Board which includes in its advertisements the names of its laboratory personnel must, in every "advertisement" [as that term is defined in rule 1200-06-03-.20(2)(a) ] it publishes, use an appropriate personnel title for each such licensee as authorized by rule 1200-06-01-.03(3) of this rule. Failure to do so may constitute an omission of a material fact which makes the advertisement misleading and deceptive and subjects the medical laboratory to disciplinary action pursuant to T.C.A. § 68-29-126(9), 68-29-126(11), 68-29-126(13), 68-29-127(8), 68-29-127(9), 68-29-127(10), and/or 68-29-129(8).(7) Severability. It is hereby declared that the sections, clauses, sentences and parts of these rules are severable, are not matters of mutual essential inducement, and any of them shall be rescinded if these rules would otherwise be unconstitutional or ineffective. If any one or more sections, clauses, sentences or parts shall for any reason be questioned in court, and shall be adjudged unconstitutional or invalid, such judgment shall not affect, impair or invalidate the remaining provisions thereof, but shall be confined in its operation to the specific provision or provisions so held unconstitutional or invalid, and the inapplicability or invalidity of any section, clause, sentence or part in any one or more instance shall not be taken to affect or prejudice in any way its applicability or validity in any other instance.Tenn. Comp. R. & Regs. 1200-06-03-.20
Original rule filed March 16, 2007; effective May 30, 2007. Amendment filed April 22, 2010; effective July 21, 2010.Authority: T.C.A. §§ 4-5-202, 4-5-204, 63-1-145, 63-1-146, 68-29-105, 68-29-126, and 68-29-129.