Marketing calls to patients: TCPA, Do Not Call and the TSR

A recall call about a cleaning that is due is one thing. A call offering a new laser package to everyone who visited in the last two years is another. Federal law treats the two very differently, and the difference turns on whether the call tries to sell something, how it is dialed, whether a recording speaks, and what kind of line it reaches. Three sets of rules apply: the Telephone Consumer Protection Act and the FCC rules under it, the national Do Not Call rules that the FCC and the FTC both enforce, and the FTC’s Telemarketing Sales Rule.

This guide covers voice calls a practice or health company places to sell a service or product. Texts, ringless voicemail and recording a call each have their own guide: see business texting rules for medical practices, ringless voicemail for medical practices and call recording consent. For reminders that do not sell anything, see text message appointment reminders and our patient recall system guide. Calls bought from a pay-per-call network raise their own kickback questions; see our guide to pay-per-call in healthcare. To keep one stop list across calls, texts and email, see patient opt-outs for email, text and calls. Faxed ads follow their own rules; see junk fax rules for healthcare.

The short version

• A call that tries to sell a product or service is telemarketing under 47 CFR 64.1200(f)(13). A call that only confirms an appointment or reports a result is not.
• A telemarketing call to a cell phone made with an autodialer or a prerecorded or artificial voice needs the person’s prior express written consent: a signed agreement naming the seller and the phone number. A prerecorded telemarketing call to a home line needs the same.
• A live person dialing by hand does not need written consent, but a live sales call to someone outside the rule’s exceptions may not go to a number on the national Do Not Call registry, or be placed before 8 a.m. or after 9 p.m. at the called person’s location.
• Anyone who asks your office to stop calling goes on your own do-not-call list. The FCC rule says the request must be honored within 10 business days and kept for 5 years.
• From November 25, 2026, a caller may name one of three methods as the exclusive way to revoke consent to robocalls and robotexts, if it discloses that method on the call or in the text.
• The FTC’s Telemarketing Sales Rule adds Do Not Call, calling time, disclosure and recordkeeping duties for campaigns that involve more than one interstate call.

Is your call telemarketing?

The FCC rule defines telemarketing at 47 CFR 64.1200(f)(13) as the initiation of a telephone call or message for the purpose of encouraging the purchase or rental of, or investment in, property, goods, or services. An advertisement, under 64.1200(f)(1), is any material advertising the commercial availability or quality of any property, goods, or services. A call offering a cosmetic treatment, a membership plan, a hearing aid trial, a supplement or a paid wellness program fits these definitions. A call that confirms Tuesday’s appointment, tells a patient a prescription is ready or asks them to call about a result does not try to sell anything.

Calls in the middle are the ones to plan for. A recall call for an exam that is due, which also mentions a new teeth whitening offer, has a sales purpose for part of its length. The rule looks at purpose, so a script that adds an offer to a reminder makes the reminder a telemarketing call. Keep reminder scripts free of offers, and run offers as a separate campaign with its own consent and Do Not Call checks.

HIPAA asks a separate question. Under 45 CFR 164.501, marketing means a communication about a product or service that encourages the recipient to purchase or use it, with exclusions that include describing the covered entity’s own health-related products and services and communications for treatment, unless the covered entity receives financial remuneration for making the communication. 45 CFR 164.508(a)(3) requires a written authorization to use protected health information for marketing. A call about your own services may fall outside HIPAA’s marketing definition and still be telemarketing under the FCC rule. The two tests do not line up, so check both. Our guide to HIPAA marketing rules covers the HIPAA side.

Robocalls: autodialers and recorded voices

The strictest TCPA rules apply to calls made with an automatic telephone dialing system or an artificial or prerecorded voice. Under 47 CFR 64.1200(f)(2), an autodialer is equipment that has the capacity to store or produce telephone numbers to be called using a random or sequential number generator and to dial such numbers. The rule names the autodialer and the artificial or prerecorded voice as alternatives, so a recorded message is covered whatever dialing method places the call.

For cell phones, 64.1200(a)(1)(iii) bars any autodialed or artificial or prerecorded voice call without the called party’s prior express consent, other than an emergency call. For calls that include an advertisement or constitute telemarketing, 64.1200(a)(2) raises the bar to prior express written consent. For home landlines, 64.1200(a)(3) requires prior express written consent for an artificial or prerecorded voice message that includes an advertisement or constitutes telemarketing.

Prior express written consent is defined at 64.1200(f)(9): an agreement, in writing, bearing the signature of the person called, that clearly authorizes the seller to deliver advertisements or telemarketing messages using an autodialer or an artificial or prerecorded voice, and the telephone number to which they may be delivered. A phone number written on an intake form, without that authorization language and a signature, does not meet this definition. If you plan recorded or autodialed offers, collect the agreement separately and keep it.

The rule also covers the messages themselves. Under 64.1200(b), every artificial or prerecorded voice message must state the identity of the business responsible for the call at the beginning, including the name it is registered under with the state, and give a callback number during or after the message. A prerecorded telemarketing message to a home line or cell phone must offer an automated opt-out, by voice or key press, within two seconds of that identification, and a message left on voicemail must give a toll free number that reaches the opt-out mechanism.

The health care message exemption and its limits

Section 64.1200(a)(2) carves out “a call that delivers a ‘health care’ message made by, or on behalf of, a ‘covered entity’ or its ‘business associate’,” using the HIPAA definitions in 45 CFR 160.103. That carve-out lifts the written consent requirement. It does not lift the requirement in 64.1200(a)(1) for prior express consent to autodialed or prerecorded calls to cell phones. For home landlines, 64.1200(a)(3)(v) lets a covered entity or business associate deliver a prerecorded health care message without consent, if it makes no more than one call per day to each patient’s residential line, up to three calls combined per week, and honors opt-out requests under paragraphs (b) and (d).

The FTC’s rule has a parallel provision. 16 CFR 310.4(b)(1)(v)(D) says the TSR’s prerecorded message rules do not apply to an outbound call that delivers a prerecorded healthcare message made by or on behalf of a covered entity or its business associate.

The rule text does not define health care message beyond pointing to HIPAA’s definitions. Read the exemption narrowly. A recorded call that pitches a cash-pay aesthetic package to past patients is hard to describe as a health care message, and a business that is not a covered entity or business associate, such as a supplement brand or a wellness app, cannot use the exemption at all. Plan those campaigns as telemarketing.

Live calls and the Do Not Call rules

A staff member who dials by hand and speaks live is outside the autodialer and prerecorded voice rules, but not outside the Do Not Call rules. The FCC calls these calls telephone solicitations. Under 64.1200(f)(15), a telephone solicitation is a call or message to encourage a purchase, but the term does not include a call to a person with that person’s prior express invitation or permission, a call to a person with whom the caller has an established business relationship, or a call by or on behalf of a tax-exempt nonprofit organization.

For telephone solicitations, 64.1200(c)(1) bars calls to a residential subscriber before 8 a.m. or after 9 p.m., local time at the called party’s location, and 64.1200(c)(2) bars calls to a number on the national Do Not Call registry. Registrations must be honored indefinitely, until the consumer cancels or the number is removed. Under 64.1200(e), these rules apply to telephone solicitations and telemarketing calls or texts to wireless numbers to the extent the FCC’s 2003 TCPA order describes.

The established business relationship is the exception most practices rely on. Under 64.1200(f)(5), it is a relationship formed by a voluntary two-way communication, based on the person’s purchase or transaction with you within the 18 months before the call, or on the person’s inquiry or application about your products or services within the three months before the call, and not ended by either party. A patient’s request not to be called ends it for telemarketing, even if the patient keeps coming to you, and the relationship does not extend to affiliated businesses unless the patient would reasonably expect it to. A patient last seen 18 months and one day ago, or a website inquiry from four months ago, falls outside the exception.

Because the calling hours rule in 64.1200(c)(1) also applies only to telephone solicitations, a call within the established business relationship exception falls outside it under the FCC rule text. The TSR’s calling time rule in 16 CFR 310.4(c), covered below, has no such exception, and state rules may not either, so keep to the hours for every sales call.

The rule also gives a safe harbor for errors. A caller is not liable for a call to a registered number if it shows the call was an error and that, as routine practice, it has written Do Not Call procedures, has trained its staff, keeps a list of numbers it may not call, and uses a version of the national registry obtained no more than 31 days before the call, with records documenting the process, under 64.1200(c)(2)(i).

Your own do-not-call list

Separate from the national registry, 64.1200(d) requires anyone making telemarketing calls to a residential subscriber, or exempt prerecorded calls under 64.1200(a)(3)(ii) through (v), to keep its own do-not-call list and meet minimum standards:

• A written policy for maintaining the list, available on demand.
• Staff who make the calls are trained in the list and how to use it.
• A request not to be called is recorded at the time it is made and honored within a reasonable time, not more than 10 business days.
• The caller gives the name of the individual caller, the name of the business on whose behalf the call is made and a phone number or address for that business.
• A request applies to the business that made the call, and to affiliates only if the person would reasonably expect them to be included.
• A request is honored for 5 years from the time it is made.

If a marketing vendor or call center keeps the list for you, 64.1200(d)(3) says the business on whose behalf the call is made is liable for any failure to honor the request. Make sure requests taken by the vendor reach your own records, and the reverse.

The consent revocation change of November 2026

Consent to robocalls and robotexts can be withdrawn. The current text of 64.1200(a)(10) lets a called party revoke prior express consent, including written consent, by any reasonable method, names methods that count per se, such as replying “stop” to a text or using a key press opt-out on a call, and says a caller may not designate an exclusive means to revoke.

The FCC changed that rule in an order published at 91 FR 67214 on October 26, 2026, effective November 25, 2026. Under the revised 64.1200(a)(10), a caller may designate any of three methods as the exclusive means to revoke consent: an automated voice or key press opt-out on a call, a reply text with one of the standardized words “stop,” “quit,” “end,” “revoke,” “opt out,” “cancel” or “unsubscribe,” or a website or telephone number the caller designates for opt-outs. The caller must clearly and conspicuously disclose the designated method on the call or in the text, and a caller that does so need not process requests made in other ways. Under the revised 64.1200(a)(11), a caller that does not designate an exclusive means must process requests made by any reasonable means. Either way, requests must be honored within a reasonable time, not more than 10 business days.

Two more points in the revised text matter for practices. A revocation in response to an informational call or text, one with no advertising or telemarketing, may be read as applying only to that category of informational calls, so a patient who stops recall messages need not lose appointment confirmations. A revocation in response to a call or text that contains an advertisement or constitutes telemarketing revokes consent to all future advertising and telemarketing calls and texts from that caller. The order says it supersedes the delayed effective date for this part of the rule, which had been extended to January 31, 2027. In a separate notice published the same day, 91 FR 67239, the FCC asked for comment on shortening the time to honor revocations, on two-way texting and on a revoke all method, so check the rule again before you rely on the current deadline.

The FTC’s Telemarketing Sales Rule

The TSR, 16 CFR part 310, applies to telemarketing as it defines the term in 310.2: a plan, program, or campaign conducted to induce the purchase of goods or services by use of one or more telephones and which involves more than one interstate telephone call. A local practice calling local patients may fall outside that definition. A health company calling customers in several states, or a call center placing calls across state lines for a practice, is more likely inside it. The TCPA rules above apply either way.

Where the TSR applies, its abusive practices section, 16 CFR 310.4, includes:

• No outbound call to a person who has asked not to receive calls from that seller, or to a number on the FTC’s Do Not Call registry, unless the seller has the person’s express written agreement, with the number and signature, or an established business relationship and no stop request, under 310.4(b)(1)(iii).
• The TSR’s established business relationship, in 310.2(q), runs 540 days from a purchase or transaction and 90 days from an inquiry or application.
• No outbound calls to a person’s residence before 8:00 a.m. or after 9:00 p.m. local time without the person’s prior consent, under 310.4(c).
• In an outbound sales call, the telemarketer must disclose promptly the identity of the seller, that the purpose of the call is to sell goods or services, and the nature of the goods or services, under 310.4(d).
• Caller ID must show the telemarketer’s number, or the seller’s name and a customer service number answered during regular business hours, under 310.4(a)(8).
• No abandoned calls: a call answered by a person must connect to a sales representative within two seconds of the greeting, with a safe harbor for an abandonment rate of no more than 3 percent per campaign under 310.4(b)(4).

Under 310.8, a seller must pay the annual fee for each area code of registry data before calling numbers in that area code, unless it calls only people who gave written agreement or have an established business relationship and does not access the registry for any other purpose. There is no charge for the first five area codes. Under 310.5, sellers and telemarketers must keep records for five years, including copies of each substantially different script, advertisement and prerecorded message and a record of each telemarketing call.

Section 310.6 lists exemptions that matter for practices. Under 310.6(b)(3), calls in which the sale is not completed, and payment is not required, until after a face-to-face sales presentation are exempt from most of the rule, but not from the Do Not Call and calling time rules in 310.4(b) and (c) or the caller ID rule in 310.4(a)(8). A call to book a consultation where the patient decides and pays in your office fits that pattern. Under 310.6(b)(5), calls a customer places in response to an advertisement, other than direct mail, are exempt, except for listed categories and any upselling on the call. So a patient who calls the number in your ad is not a TSR outbound call, but an offer for a second service added during that call is an upsell the exemption does not cover.

A state example: Florida

State laws add their own layer, and 47 USC 227(f)(1) says the TCPA does not preempt more restrictive state rules on intrastate calls. We read Florida’s law as one example. The Florida Telephone Solicitation Act, section 501.059 of the Florida Statutes (2026), defines a telephonic sales call to include a call, text message or voicemail transmission to solicit a sale of consumer goods or services. Under 501.059(1)(k), an unsolicited telephonic sales call is one not made in response to the person’s express request, not primarily about an existing debt or contract, and not to a person with whom the telephone solicitor has a prior or existing business relationship. Section 501.059(8)(a) bars an unsolicited telephonic sales call that uses an automated system for the selection and dialing of telephone numbers, or plays a recorded message, without the called party’s prior express written consent, and 501.059(4) bars unsolicited calls to numbers on Florida’s own quarterly do-not-call listing. Section 501.059(10) lets a called party sue for actual damages or 500 dollars, whichever is greater, with up to three times that amount for willful or knowing violations, and for text messages requires the person to reply “STOP” first and give the solicitor 15 days to stop.

Florida’s Telemarketing Act adds limits on timing. Section 501.616(6) bars a commercial telephone seller or salesperson, as the act defines them, from making commercial telephone solicitation calls before 8 a.m. or after 8 p.m. in the called person’s time zone, and more than three such calls from any number to a person in a 24-hour period on the same subject. Section 501.604 lists exemptions from that part of the statutes, but says they do not reach 501.616(6) and (7). Florida’s evening cutoff is one hour earlier than the federal 9 p.m. limit, so a campaign into Florida that follows only the federal rule can still break the state rule.

What a violation can cost

The TCPA lets the person called sue. Under 47 USC 227(b)(3), a person may recover actual monetary loss or 500 dollars for each violation of the robocall rules, whichever is greater, and a court may increase the award to up to three times that amount for willful or knowing violations. Under 227(c)(5), a person who received more than one call within 12 months by or on behalf of the same entity in violation of the Do Not Call rules may recover actual loss or up to 500 dollars per violation, also up to three times for willful or knowing violations, with an affirmative defense for a caller that has reasonable practices and procedures to prevent such calls.

The FTC enforces the TSR as a trade regulation rule. Under 15 USC 45(m)(1)(A), a knowing violation of such a rule can bring a civil penalty of up to 10,000 dollars per violation as written in the statute. The FTC adjusts that figure for inflation each year: 16 CFR 1.98(d) sets 53,088 dollars for penalties assessed after January 17, 2025.

An illustration

This example is invented. [Practice name], a dermatology and aesthetics practice in [city], wants to call past patients about a new body contouring service. Its first plan is a recorded message sent through a dialing platform to every number in its records. Reading 64.1200(a)(2) and (a)(3), the office manager sees that a recorded sales message needs signed written consent for each number, which the practice does not have. The recall exemption does not fit either, because the call sells a cash-pay service.

The practice changes the plan. Staff place live calls by hand, between 9 a.m. and 7 p.m. local time, only to patients seen in the last 18 months who have not asked not to be called. They scrub the list against the national registry downloaded that month, and, as a precaution, against Florida’s list for patients with Florida numbers. The script opens with the staff member’s name, the practice name and the reason for the call, and a stop request goes on the practice’s list the same day. For the future, the practice adds a separate, signed consent line for recorded and text offers to its intake paperwork, with the phone number filled in.

Checklist

• Sort every planned call into reminder or result, telemarketing, or both, and keep offers out of reminder scripts.
• Use live, hand-dialed calls for sales unless you hold signed prior express written consent for recorded or autodialed calls.
• Collect written consent on its own line, naming your practice and the phone number, and store it with the patient’s contact record.
• Scrub sales call lists against the national registry within 31 days of calling, and against each state list that applies.
• Check the 18 month and three month established business relationship windows, and the TSR’s 540 and 90 day windows where the TSR applies.
• Call only between 8 a.m. and 9 p.m. at the called person’s location, or tighter where a state sets tighter hours, such as 8 p.m. in Florida.
• Keep a written do-not-call policy, train staff on it, record stop requests at once and honor them within 10 business days, for 5 years.
• Name your business at the start of any recorded message and provide the opt-out mechanism the rule requires.
• Decide whether to designate an exclusive revocation method once the November 25, 2026 rule takes effect, and disclose it on each call or text if you do.
• Require vendors and call centers to share stop requests with you both ways, and keep the records the TSR asks for.
• Have a health care attorney review the plan, the scripts and the consent language before launch.

How we help

We build websites, local and organic search, Google Ads and lead generation and an AI front desk for independent practices. For calling campaigns, that means keeping reminders and offers apart, writing consent language that names the practice and the number, and setting up the stop request process before the first call goes out. Our tools are built with HIPAA in mind. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We are not a healthcare provider and we do not give legal or medical advice. Read our guide to healthcare marketing rules for the wider picture.

Sources

• 47 CFR 64.1200: Delivery restrictions (eCFR, up to date as of October 29, 2026)
• FCC: Enhancing the Ability of Consumers To Control the Robocalls, 91 FR 67214 (October 26, 2026; effective November 25, 2026)
• FCC: Modernizing the Ability of Consumers To Control Robocalls, proposed rule, 91 FR 67239 (October 26, 2026)
• 47 USC 227: Restrictions on use of telephone equipment (subsections (b)(3), (c)(5), (f)(1))
• 16 CFR part 310: Telemarketing Sales Rule (sections 310.2, 310.4, 310.5, 310.6, 310.8)
• 16 CFR 1.98: Adjustment of civil monetary penalty amounts
• 15 USC 45: Unfair methods of competition unlawful (subsection (m)(1)(A))
• 45 CFR 164.501: Definitions (marketing)
• 45 CFR 164.508: Uses and disclosures for which an authorization is required (paragraph (a)(3), marketing)
• Florida Statutes 501.059: Telephone solicitation (2026)
• Florida Statutes 501.604: Exemptions (2026)
• Florida Statutes 501.616: Unlawful acts and practices (2026)

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