Specialty pharmacy and patient support program marketing

Specialty pharmacies and the patient support programs that sit around expensive medicines do a great deal of patient-facing communication. They explain benefits checks, enroll patients in copay help, call to arrange deliveries, offer nurse support and send refill reminders. Much of that work is useful to patients. Some of it is also marketing, and a few pieces of it touch federal rules that carry criminal penalties, not just a stern letter.

This guide is for owners and marketing staff at specialty pharmacies, the teams that design manufacturer support programs and hub services, and the agencies that write their materials. It covers copay coupons and Medicare and Medicaid patients, independent charity assistance, support services that drift into promotion, and the HIPAA rules for patient data in these programs. It names no brands or drugs and gives no figures about any program. For retail pharmacies, see our guide to independent pharmacy marketing.

The short version

• Copay coupons are remuneration. OIG says manufacturer copay coupons implicate the anti-kickback statute when the drug is paid for by a federal health care program, and pharmacies that accept them for those patients may face sanctions too.
• Charity assistance must stay independent. A manufacturer may donate to an independent charity, but it must not steer how the charity defines its disease funds or learn which patients used its products.
• Support services can be promotion. Material about a drug that a manufacturer or someone acting for it hands out is generally treated as labeling or advertising, with the fair balance rules that come with it.
• Patient data needs the right HIPAA route. Refill reminders for a drug a patient already takes are not marketing under HIPAA, but paid messages about other products and sales of patient data need the patient’s written authorization.

Who is who in a patient support program

Support programs involve several parties, and the rules depend on which one is speaking. Getting this map right first saves arguments later:

• The manufacturer makes the drug, often funds the program and usually controls the brand’s patient materials.
• A hub or support services vendor runs benefits checks, enrollment, case management and nurse calls under contract with the manufacturer.
• The specialty pharmacy dispenses the drug, bills the patient’s plan and usually runs its own patient care and adherence program. It is a HIPAA covered entity.
• The prescriber’s office sends the prescription and clinical documents and often helps with prior authorization. It is also a covered entity.
• An independent charity may help eligible patients with cost sharing from disease funds supported by donors, including manufacturers.

A message that is fine from one party can be a problem from another. A pharmacy reminding its own patient about a refill is routine. The same reminder written and paid for by a manufacturer and sent from the pharmacy’s patient list is a different arrangement with different rules.

Copay coupons and federal program patients

The OIG bulletin on copayment coupons defines them broadly: print and electronic coupons, debit cards and direct reimbursements that manufacturers offer insured patients to reduce or remove out-of-pocket costs for a specific drug. OIG states that these coupons are remuneration offered to consumers to induce the purchase of specific items, and that when the drug is payable by a federal health care program, including Medicare Part D, the anti-kickback statute is implicated (42 USC 1320a-7b(b)). It adds that a claim resulting from a kickback violation is a false claim under the False Claims Act.

The bulletin notes that coupons typically say they may not be used by federal program beneficiaries, and it puts the duty to make that work on the manufacturer: failing to take appropriate steps to keep coupons from inducing purchases paid for by these programs may be evidence of intent to induce them. It also says pharmacies that accept manufacturer coupons for copayments owed by federal program beneficiaries may be subject to sanctions under the anti-kickback statute, the beneficiary inducement civil monetary penalty and the False Claims Act. The beneficiary inducement provision (42 USC 1320a-7a(a)(5)) covers remuneration that is likely to influence a Medicare or Medicaid beneficiary to choose a particular provider, practitioner or supplier, which can include a pharmacy.

What that means for marketing copy:

• Put the eligibility limit where people see it, not only in the fine print of the terms. Pages, emails, texts and call scripts that offer copay help should say that patients with Medicare, Medicaid or other federal coverage are not eligible for the manufacturer coupon.
• Ask about coverage before enrolling a patient, and record the answer. A pharmacy’s intake and the hub’s enrollment script should both do this.
• Do not describe copay help as something every patient gets. “Pay as little as” claims need the conditions, the eligibility rules and any program maximum next to them.
• Do not promote a coupon as a reason to choose your pharmacy over another for federal program patients.

Pharmacies that run their own discount offers face the same inducement question from a different angle. Our guides to prescription discount card marketing and to price matching and competitor coupons cover those.

Independent charity assistance

OIG’s copay coupon bulletin points to another route: manufacturers that want to help federal program beneficiaries who cannot afford their cost sharing can donate to independent charities that help patients without regard to which drug they use. The 2014 supplemental bulletin on independent charity patient assistance programs explains what keeps that route independent, and much of it comes down to communication and data:

• No donor control. OIG repeats its earlier position that manufacturers and their affiliates should not exert direct or indirect influence or control over the charity or its programs, and should not influence how disease funds are identified.
• Broad disease funds. OIG is concerned about funds defined so narrowly that a donor’s donations end up subsidizing its own products, and lists approaches such as funds defined by specific symptoms, severity, stage of a disease or type of drug treatment as examples of improper narrowing.
• Aggregate reports only. OIG describes charities certifying that donors receive only aggregate data, such as the number of applicants, the number who qualified and the amount paid out, so a donor cannot correlate its donations with use of its own products. OIG adds that donor efforts to make that correlation may indicate an intent to channel support to its own products.

For marketing teams this has practical effects. A manufacturer’s patient materials can tell patients that independent charities exist and how to find them, but should not imply that a charity will fund its product, should not route patients to a single fund as if it were part of the brand program, and should not ask the charity or a hub for reports that link donations to the brand’s patients. A specialty pharmacy that helps patients apply to charities should present the options neutrally.

Hub services, nurse support and promotion

Support services are sold to patients as help, and much of the time they are. But when a manufacturer or a vendor acting for it provides material about its drug, FDA’s rules on drug labeling and advertising are in play. Under 21 CFR 202.1(l)(2), brochures, mailing pieces, letters, sound recordings, literature and similar printed, audio or visual matter describing a drug, supplied by the manufacturer and disseminated by or on its behalf, are labeling. Prescription drug advertisements must present a fair balance between effectiveness and risk information under 21 CFR 202.1(e)(5)(ii). For the broader picture, see our guide to prescription treatment advertising rules from FDA and FTC.

Where support programs tend to slip:

• Welcome kits and emails that describe how well the drug works, with no risk information, because they were written as “service” content.
• Nurse educator scripts that move from injection training and side effect reporting into benefit claims or uses that are not in the approved labeling.
• Program names and websites that read like brand ads. If the program site is part of the brand’s promotion, review it the way you would review the brand site.
• Free goods and services to prescribers’ offices that go beyond the program’s own administration, such as staff time doing general office work. Those raise the same kickback questions as any other gift to a referral source; see gifts and meals for referring physicians.

Send support program materials through the same medical, legal and regulatory review as other brand materials, and keep scripts for clinical staff limited to the approved labeling and the program’s operations.

Patient data in support programs

Support programs run on patient information: prescriptions, insurance details, prior authorization documents, refill history. The HIPAA Privacy Rule applies to the covered entities in the chain (pharmacies, prescribers and health plans), and it decides what they may share with a manufacturer or hub and what they may send to patients.

Two parts of the rule matter most for marketing:

• The marketing definition. Under 45 CFR 164.501, marketing means a communication about a product or service that encourages recipients to buy or use it. The definition excludes refill reminders and other communications about a drug or biologic currently prescribed for the individual, as long as any payment the covered entity receives for sending them is reasonably related to its cost of sending them.
• Authorizations. Under 45 CFR 164.508(a)(3), a covered entity needs the patient’s authorization to use or disclose protected health information for marketing, apart from face-to-face communication and promotional gifts of nominal value. If a third party pays the covered entity for the marketing, the authorization must say so. Under 164.508(a)(4), a sale of protected health information also needs an authorization.

Applied to a specialty pharmacy, this means a reminder about a patient’s current therapy is usually not marketing, even if a manufacturer helps fund it, provided the payment only covers the cost of the communication. A message, funded by a manufacturer, that suggests a different or additional product is marketing and needs authorization. Selling or licensing patient-level data to a manufacturer needs authorization that covers a sale. Manufacturers that want patient-level data from a hub usually get it through an authorization signed at enrollment, so the enrollment form, its plain-language explanation and the consent records are part of your marketing compliance. Our guide to HIPAA marketing rules explains the definition and its exceptions in more detail.

An illustration

Take a hypothetical specialty pharmacy that wants to grow its share of patients on a therapy for a chronic condition. Its draft campaign offers a “$0 copay for every patient” banner on its website, a text message to all patients with the condition encouraging them to ask about a newer drug, and a monthly report to the manufacturer listing which patients started the drug and which charity fund paid their cost sharing.

Each piece needs work. The banner overstates the coupon and does not say federal program patients are not eligible, so it becomes a clear statement of conditions and eligibility, with coverage asked at intake. The text message is about a product the patients are not taking; if a manufacturer pays for it, it is marketing that needs authorization, so it becomes a general message about the pharmacy’s services or is dropped. The report links named patients to a charity fund and a manufacturer’s product, which runs against the independence OIG describes and may be a disclosure that needs authorization, so it is cut back to what the program’s contracts, authorizations and OIG guidance allow.

Checklist

• Copay coupon offers state that patients with federal health care program coverage are not eligible, and intake records each patient’s coverage.
• Savings claims show the conditions, eligibility rules and any program limits next to the claim.
• Charity information is neutral, names no single fund as part of a brand program, and no one asks for reports linking donations to a brand’s patients.
• Support materials that describe a drug go through medical, legal and regulatory review and carry fair balance where required.
• Nurse and call center scripts stay within the approved labeling and program operations.
• Refill reminders cover only current therapy, and any payment for them is limited to the cost of sending them.
• Messages about other products, and any sale of patient data, rely on a signed HIPAA authorization that states any payment.
• Enrollment forms explain in plain language what data goes to the manufacturer or hub, and consent records are kept.

How we help

We build websites, content and lead generation for health companies, pharmacies and practices, and for pharmacies and support programs we write offers with the eligibility rules in view and keep patient data out of the marketing stack unless the right authorization is in place. See our lead generation service, our guides to compounding pharmacy marketing and online pharmacy advertising rules, or the full list of guides for health companies.

Sources

• 42 USC 1320a-7b: Criminal penalties for acts involving Federal health care programs (anti-kickback statute, (b))
• 42 USC 1320a-7a: Civil monetary penalties ((a)(5) beneficiary inducement)
• OIG Special Advisory Bulletin: Pharmaceutical Manufacturer Copayment Coupons (September 2014)
• OIG Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs (79 FR 31120, May 30, 2014)
• 21 CFR 202.1: Prescription-drug advertisements ((e)(5), (l)(2))
• 45 CFR Part 164: 164.501 (marketing definition) and 164.508(a)(3) and (a)(4)

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