Flu shot clinic marketing: free shot wording, patient incentives and referral rules

Every fall, practices, urgent care centers and pharmacies run some version of the same campaign: walk in or book online, get your flu shot, often at no cost to you. It is one of the simplest pieces of marketing a practice does all year, and most of it is routine. But a flu shot campaign touches more rules than its size suggests, because the vaccine is a covered preventive service for many patients, because Medicare and Medicaid patients are a large part of the audience, and because practices like to sweeten the offer.

This guide covers the parts that cause trouble: saying “free” accurately, giving shots or gifts to Medicare and Medicaid patients, offering free shots to people who send you patients, reminder messages under HIPAA, and how to talk about the vaccine itself. It does not cover clinical questions such as which vaccine a patient should get. Those belong to the clinician and the current CDC recommendations, not to an ad.

“Free flu shot”: say what the coverage rule actually says

Most “free flu shot” ads lean on a coverage rule, not on the practice giving anything away. The rule is real, but it has conditions, and the ad should carry them.

For Medicare patients, the Medicare.gov coverage page for flu vaccines says Part B covers the seasonal flu vaccine, usually once each flu season, and that the patient pays nothing “if your doctor or other health care provider accepts assignment for giving the vaccine.” So the accurate version of the offer is tied to assignment. If your practice accepts assignment, you can say that Medicare patients pay nothing for the flu shot. If some of your clinicians do not, the ad should not imply that everyone pays nothing.

For patients with private coverage, 45 CFR 147.130(a)(1)(ii) requires group health plans and health insurance issuers subject to the rule to cover, without cost sharing, immunizations that have a recommendation in effect from the CDC’s Advisory Committee on Immunization Practices (ACIP), once that recommendation has been adopted by the CDC Director. Paragraph (a)(3)(i) adds that, with limited exceptions, a plan with a network is not required to cover those services from an out-of-network provider, and may impose cost sharing when it does. So “no cost with most insurance” is a claim you cannot check for every patient. “No cost for many insured patients when we are in your plan’s network” is one you can. Our guide to primary care practice marketing covers the preventive services rule in more detail.

Then there is the FTC’s guide on the word “free”, 16 CFR 251.1. It was written for retail offers, but its central point carries over to any “free” health offer. Under 251.1(c), all the terms, conditions and obligations on which a free offer depends “should be set forth clearly and conspicuously at the outset of the offer,” and the rule says a footnote reached by an asterisk next to the offer is not disclosure at the outset. For a flu shot ad, the conditions are things like which insurance you bill, whether the patient must be an existing patient, age limits, and what an uninsured patient pays. Put them next to the word, not under it.

Wording that tends to hold up:

• “Flu shots at no cost to Medicare Part B patients. We accept assignment.” (Only if that is true for the clinicians giving the shots.)
• “No cost for many insured patients when we are in your plan’s network. Call or check your plan to confirm.”
• “No insurance? Flu shots are [your price].” (Your actual self pay price, stated plainly.)
• “Walk in or book online. Existing and new patients welcome.” (Only if new patients really can walk in.)

Giving the shot away to Medicare and Medicaid patients

Some practices go further and give the shot itself for free, without billing anyone. That is generous, and for patients without federal coverage it is mostly a question of honest advertising. For Medicare and Medicaid patients it raises a different question.

Under 42 U.S.C. 1320a-7a(a)(5), a person who “offers to or transfers remuneration” to a Medicare or state health care program beneficiary, which the person knows or should know is likely to influence the beneficiary to order or receive from a particular provider, practitioner or supplier any item or service payable by those programs, can face civil monetary penalties. The OIG’s December 7, 2016 policy statement notes that the statute defines remuneration to include “transfers of items or services for free or for other than fair market value.”

A free shot is therefore something of value in the eyes of this law. Whether it is a problem depends on what it is likely to influence. A free shot offered at a community event with no tie to anything else is a different case from a free shot offered to bring Medicare patients into the office for billed visits. That is a judgment for counsel, and our guide to health fairs and free screening events walks through the same question for screenings.

Gift cards and other incentives for getting vaccinated

Incentives are where flu campaigns most often drift. A coffee card for every shot, a raffle for patients who book by a certain date, a branded water bottle. For Medicare and Medicaid patients, two parts of the rules matter.

The first is nominal value. In the same December 7, 2016 policy statement, OIG says it interprets nominal value as “a retail value of no more than $15 per item or $75 in the aggregate per patient on an annual basis,” and that the items may not be cash or cash equivalents. A gift at or below those amounts does not need to fit an exception. Remember that the annual total counts everything a patient receives from you during the year, not only flu season gifts. Our guide to marketing to Medicare patients covers nominal value and the other exceptions in full.

The second is the preventive care exception in 42 CFR 1003.110. It allows incentives “to promote the delivery of preventive care services where the delivery of such services is not tied (directly or indirectly) to the provision of other services” reimbursed by Medicare or a state health care program. The incentive may not be cash or an instrument convertible to cash, and may not be disproportionately large compared with the value of the preventive care service. The same section defines preventive care for this exception as a prenatal service, a post-natal well-baby visit, or “a specific clinical service described in the current U.S. Preventive Services Task Force’s Guide to Clinical Preventive Services,” that is also reimbursable by Medicare or a state health care program.

Notice that this definition points to the Task Force, while 45 CFR 147.130 lists Task Force recommendations and ACIP immunizations as separate categories. Do not assume a vaccine fits the preventive care exception just because it is preventive in the everyday sense. If you want to offer anything above nominal value to Medicare or Medicaid patients for getting vaccinated, get a written answer from counsel first. The simplest plan is to keep any gift within nominal value and never use cash or anything that works like cash.

Free shots for the people who send you patients

A common fall offer is aimed not at patients but at partners: free flu shots for the staff of a nursing facility, a home care agency, a physician office or a pharmacy that sends you patients. That is a different law.

Under the federal Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b)(2), it is a crime to knowingly and willfully offer or pay “any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind” to induce someone to refer an individual for an item or service payable by a federal health care program, or to arrange for or recommend such items or services. Free vaccines and free administration for a referral source’s staff can be remuneration in kind. Whether the purpose is to induce referrals is a question of fact, which is why the safest course is not to offer free services to referral sources at all unless counsel has approved the arrangement in writing. Our guide to patient and physician referrals covers the statute and its safe harbors.

An on-site flu clinic for an employer that pays a fair price for the service is a different arrangement from free shots for a referral partner. Price it as you would any other contracted service, put it in writing, and keep it separate from any referral relationship.

Reminders, recall and HIPAA

Flu season reminders are usually the most effective part of the campaign, and usually the least risky under HIPAA. Under 45 CFR 164.501, a communication made for the treatment of an individual by a health care provider is excluded from the definition of marketing, and so is a communication describing a health-related product or service that the practice itself provides. A message telling your own patients that flu shots are available at your office generally fits those exclusions.

The answer changes when someone else pays. If a vaccine manufacturer, distributor or other third party pays the practice to send the reminder, and the message encourages the patient to use that party’s product, it becomes marketing involving financial remuneration. Under 45 CFR 164.508(a)(3), that requires the patient’s prior written authorization, and the authorization must state that remuneration is involved. Our guide to HIPAA marketing rules covers the definition and its exclusions, and our patient recall guide covers how to run reminder lists.

HIPAA is not the only rule for the channel. Texts and calls have their own consent rules; our guides to text message appointment reminders and healthcare email marketing cover them.

Children who qualify for the federal Vaccines for Children program get flu vaccine under separate rules on eligibility, administration fees and how you describe the vaccine as no cost. Those rules are in our guide to Vaccines for Children provider marketing.

Talking about the vaccine itself

A flu shot ad is a health claim, even when it is short. The FTC Health Products Compliance Guidance (December 2022) says that, as a general rule, claims about the health benefits or safety of drugs and other health-related products “require substantiation in the form of competent and reliable scientific evidence.” A practice is unlikely to have its own studies, so in practice the evidence is what public health authorities have published. When flu or another illness is in the news, our guide to advertising during an outbreak covers claims for services other than the vaccine, emergency pricing and texts.

A few habits keep vaccine messaging accurate:

• Quote or link the current CDC or ACIP recommendation instead of paraphrasing it, and date the page you link to. Recommendations change from season to season.
• Do not put effectiveness percentages in ads. They vary by season, by age group and by study, and a number that was right last year can be wrong this year.
• Do not name vaccine products in ads. Which product a patient receives depends on their age, health and what is in stock, which is a clinical decision made at the visit.
• Avoid fear appeals and guarantees. “Do not get the flu this year” promises an outcome no vaccine can promise.
• Keep eligibility claims general and accurate. “Ask us whether a flu shot is right for you” is better than a list of who should get one copied from an old flyer.

Shingles, pneumococcal and RSV vaccines for adults have their own coverage rules and a federal recommendation that is in court; our guide to adult vaccine outreach covers those pages.

What the booking page should say

Most flu shot campaigns end on a booking page or a walk-in page. That page does more work than the ad, and it is where the conditions from the sections above belong.

• Dates, hours and locations. Including whether walk-ins are accepted and whether new patients can come in.
• Cost and insurance. Medicare assignment, the plans you are in network with, and the self pay price.
• What to bring. Insurance card, a list of current medications and any questions for the clinician.
• The vaccine information sheet. Under 42 U.S.C. 300aa-26(d), a provider who gives a vaccine listed in the Vaccine Injury Table must give the patient, or a child’s legal representative, the federal vaccine information materials before giving the vaccine. Saying on the page that you will provide it, and linking to the current CDC sheet, sets expectations.
• Privacy. A booking form that collects health information is not a place for advertising tags. Our guide to tracking pixels on practice websites explains why.

Your Google Business Profile is often the first place a patient looks for flu shot hours. Keep hours accurate and use posts for clinic dates; our guide to Google Business Profile for doctors covers the listing rules.

Illustration: one practice’s fall campaign

Illustration only; this practice is invented. A family practice with two locations wants to increase flu vaccination among existing patients and attract some new ones.

1. The offer.“Flu shots at both offices, weekdays and two Saturday clinics. No cost to Medicare Part B patients; we accept assignment. Many insured patients pay nothing when we are in network. Self pay [your price].” All of it sits next to the headline, not under an asterisk.
2. The reminder.A text and email to existing patients, sent by the practice about its own service, with no third party paying for it. It links to the booking page and honors patients who have asked to be contacted another way.
3. The incentive.None for Medicare and Medicaid patients beyond a sticker and a printed care card, both far below nominal value. No gift cards.
4. The partners.The practice is asked to give free shots to the staff of a nearby facility that sends it patients. It declines and offers a priced, written on-site clinic instead, after checking with counsel.
5. The claims.The ads link to the current CDC flu vaccine page and do not state effectiveness numbers or product names.

A short checklist before the campaign starts

• Every “no cost” claim names the condition (Medicare assignment, in-network plans) right next to it.
• The self pay price is published.
• Gifts to Medicare and Medicaid patients stay within $15 per item and $75 per patient per year in total, and are never cash or cash equivalents.
• No free shots or services for staff of referral sources without written approval from counsel.
• Reminders describe your own service, and no third party pays you to send them.
• Ads link to the current CDC recommendation and carry no effectiveness numbers or product names.
• The booking page lists hours, cost, what to bring and the vaccine information sheet, and has no advertising tags.

How we help

We are a marketing studio, not a law firm, and we do not give clinical advice. For flu season, our patient acquisition work builds the reminder and recall campaigns for your own patients, our Google Ads for practices service runs local flu clinic ads with the conditions in the ad text, and our medical website design work builds booking pages that state the cost and keep advertising tags off forms. 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 do not promise a number of bookings.

Frequently asked questions

Sources

• Medicare.gov: Flu vaccines (coverage, costs and assignment)
• 45 CFR 147.130: Coverage of preventive health services
• 16 CFR 251.1: Guide Concerning Use of the Word “Free” and Similar Representations
• 42 U.S.C. 1320a-7a: Civil monetary penalties (beneficiary inducement)
• 42 CFR 1003.110: Definitions (remuneration exceptions, preventive care)
• OIG Policy Statement Regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries (December 7, 2016)
• 42 U.S.C. 1320a-7b: Criminal penalties for acts involving federal health care programs (Anti-Kickback Statute)
• 45 CFR 164.501: Definitions (marketing)
• 45 CFR 164.508: Uses and disclosures for which an authorization is required
• 42 U.S.C. 300aa-26: Vaccine information
• FTC: Health Products Compliance Guidance (December 2022)

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