compliant direct mail marketing

How to Reap the Benefits of Direct Mail While Staying Compliant

Direct mail is far from obsolete, with an ROI similar to social media marketing and a response rate far higher than email. This channel is still very relevant and highly useful for healthcare marketers. It has a wide range of uses including:

  • Generating walk-in traffic
  • Hitting a targeted mail list based on internal patient demographic data
  • Nurturing preventive care through healthy reminder and tips
  • Distributing patient testimonials
  • And of course, generating new patients

One of the reasons direct mail is so effective is due to a concept known as “The Rule of Reciprocity.” This rule basically states that when someone receives a gift, in this case something tangible that provides definable value to the recipient such as a newsletter, they feel driven to respond.

But, just as with the other forms of marketing that we discussed in earlier parts of this series, how can this effective tool be utilized in the hyper-regulated healthcare marketing environment? Here are some of the guidelines provided by the agencies that have the most say in what is and is not permissible.

HIPAA Compliance

With HIPAA compliance, it’s important to keep in mind that the privacy rule has very specific definitions on what constitutes “marketing.” If your mailer falls under this heading, then in most cases, permission from the patient must be obtained before sending any materials. A privacy policy must also clearly identify how collected patient data will be used. Review HIPAA guidelines to determine the precise nature of what the Department of Health and Human Services considers marketing and if your organization falls under this rule.

When sending out direct mail, there are several mandates on what must be included on the mailer itself:

  • The marketing communication must clearly and prominently identify the organization making the communication.
  • The communication must disclose whether a covered entity, such as a healthcare provider or partner, has received or will receive direct or indirect remuneration for making the communication.
  • Opt-out instructions must be included, with the exception of mass mailers such as newsletters.
  • A covered entity is required to make a determination prior to distributing the communication that the product or service being marketed may be beneficial to the health of the type or class of individual being targeted.
  • The marketing communication must explain why the individual has been targeted and how the product or service relates to the health of the individual.


The Food and Drug Administration requires that drugs/treatments being marketed should be FDA approved. If they are not, there must be multiple disclosures to this fact included on the mailer. Any claims made on the mailer must be substantiated with scientific evidence.

Drug companies, in particular, must include a “Brief Summary” of risk information and side effects on the drug advertised. One requirement for broadcast ads would also be helpful for direct mail –broadcast advertisers include in the ad a number of sources that can provide a drug’s prescribing information. These sources may include:

  • A health care professional
  • A toll-free telephone number for information
  • The current issue of a magazine that contains a print ad with information
  • A website URL


The Federal Trade Commission also requires that efficacy claims for a healthcare product be proven. The difference is that FTC penalties can be even more severe. Marketers of a dietary supplement called Procera AVH settled for $1.4 million in penalties with the FTC when they claimed their product was “clinically proven” to improve memory, mood, and other cognitive functions on direct mail flyers and other communications. This is just one example of a host of fines levied by the FTC in cases involving healthcare marketing.


Medicare has some common-sense guidelines and some rules that are more complicated. One simple rule is that mailers should clearly state that this is advertising material for the purpose of soliciting business, with any exaggerated claims carefully avoided. Some of the more specific rules focus on Plans/Part D sponsors including a prohibition on marketing for a plan for the upcoming year prior to October 1st,  prohibitions on advertising outside of defined services areas and joint enterprises that market under a single name. Considering the broad nature of this topic, we encourage you to review Medicare guidelines for more information.

All of these topics go much deeper than what we can cover here, and this information should not be considered comprehensive. In addition to Medicare, we encourage to review HHS, FTC and FDA  guidelines and consult a HIPAA lawyer if needed, to provide you with the insight necessary to capitalize on healthcare direct mail in both a legal and effective manner.

Contact us for a free audit of your healthcare direct mail marketing, 

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