Mobile phlebotomy marketing: CLIA, EKRA and privacy

Mobile phlebotomy services send a trained person to a patient’s home, workplace or care facility to draw blood or collect other specimens, then deliver the specimens to a laboratory. The business looks simple from the outside, but its marketing touches several federal rules at once: what counts as a laboratory, when Medicare pays for a home draw, how the service may be paid by labs and referral sources, and what happens to the health information a booking form collects.

This guide is for owners of mobile draw companies, practices that add home draws, and labs that work with them. It covers what your website and ads can say about testing, Medicare and partners, which payment arrangements federal law treats as referral payments, and the privacy questions behind online booking. For selling lab tests straight to consumers, see our guide to direct-to-consumer lab testing marketing. For how labs market to ordering physicians, see clinical lab marketing to physicians.

This is general information, not legal advice. Sources cited were checked on November 1, 2026: 42 CFR 493.2, 493.3, 493.15 and 493.35, 45 CFR 160.103 and 45 CFR 102.3 in the eCFR version up to date as of October 29, 2026; 42 USC 1395l(h)(3), 42 USC 1320a-7b(b), 42 USC 1320a-7a(a), 18 USC 220, 18 USC 24(b), 15 USC 45(a) and 15 USC 52 in the Cornell LII text of the U.S. Code; and the OIG Special Fraud Alert on Laboratory Payments to Referring Physicians (June 25, 2014). We did not read the Medicare Claims Processing Manual, Medicare Administrative Contractor guidance, OIG advisory opinions, case law, ad platform policies or any state law for this guide. State law may also license phlebotomists, regulate specimen collection stations or limit who may order tests; we did not read state rules.

The short version

Collecting is not testing. Under the CLIA rules, a facility that only collects or prepares specimens, or only acts as a mailing service, and does not perform testing is not a laboratory (42 CFR 493.2). Do not call yourself a lab, or “CLIA-certified”, unless you hold a CLIA certificate.
If you run tests on site, CLIA applies. A laboratory needs a CLIA certificate that covers the tests it performs (42 CFR 493.3(a)), and a waived-test laboratory that moves between sites may be covered under the certificate of its home base (42 CFR 493.35(b)(1)).
Medicare’s travel fee is narrow. The statute provides a nominal collection fee and a separate travel fee, and the travel fee is limited to homebound individuals and inpatients of a facility other than a hospital (42 USC 1395l(h)(3)).
Per-specimen pay from a lab is a red flag. EKRA makes it a crime to solicit or receive remuneration for referring patients to a laboratory, for services paid by any public or private health care benefit program (18 USC 220(a)). OIG has warned about labs paying per specimen for collection and processing (Special Fraud Alert, June 25, 2014).
Booking forms collect health information. Whether HIPAA applies to you depends on the definitions in 45 CFR 160.103, and it affects which tracking tools belong on your booking pages.

Collecting is not testing: what CLIA means for your website

The federal laboratory rules in 42 CFR part 493 define a laboratory as a facility that examines materials from the human body to provide information for diagnosis, prevention or treatment, or to assess health. The same definition says: “Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories” (42 CFR 493.2).

For a draw-only service, that has two consequences for marketing. First, the tests your patients receive are performed by someone else, so a page that says “our lab”, “we test your blood” or “lab results from our team” misstates who does the work. Second, “CLIA-certified” describes a certificate held by a laboratory. If you are not a laboratory, you do not hold one. Wording that stays accurate: “we collect your sample and deliver it to the laboratory your clinician ordered from”, or, where true, “samples are tested by [named partner lab], which holds a CLIA certificate”. Check the partner’s certificate before you say so, and keep the claim current if you change labs.

Some mobile services also run quick tests at the visit, such as a glucose check. Once you examine specimens to give health information, you are performing testing, and 42 CFR 493.3(a) requires a laboratory to hold a current certificate (of waiver, registration, compliance, provider-performed microscopy procedures or accreditation) that covers the category of tests it performs, unless an exception applies. A certificate of waiver is limited to the waived tests listed in or added under 42 CFR 493.15. For waived-test laboratories that move between sites, 42 CFR 493.35(b)(1) lets laboratories “that move from testing site to testing site, such as mobile units” be covered under the certificate of a designated primary site or home base, using its address. Your service pages should only list on-site tests your certificate covers.

Medicare home draws: what the fee covers and who qualifies

Medicare Part B provides two collection-related payments in the statute. 42 USC 1395l(h)(3)(A) provides “a nominal fee to cover the appropriate costs in collecting the sample” for a clinical diagnostic laboratory test paid under Part B, with no more than one such fee for samples collected in the same encounter. 42 USC 1395l(h)(3)(B) provides a fee for the transportation and personnel expenses of trained personnel who travel to the individual’s location to collect the sample, but only “with respect to an individual who is homebound or an inpatient in an inpatient facility (other than a hospital)”.

That limit matters for ads. A headline such as “Medicare pays for your home blood draw” aimed at every Medicare patient overstates the statute, because the travel fee is tied to homebound status or a non-hospital inpatient stay, and coverage of the test itself depends on Medicare’s own criteria. More accurate wording: “We accept Medicare for eligible home draws. Medicare pays a travel fee only for patients who are homebound or living in a facility such as a nursing home. We check eligibility before your visit.” The detailed billing rules sit in the Medicare Claims Processing Manual and contractor guidance, which we did not read for this guide; have your biller confirm them before you publish coverage wording.

If you charge self-pay patients a travel or convenience fee, show it with the draw price instead of adding it at checkout. Our guide to advertising cash prices covers how to present a base price and add-on fees.

Getting paid by labs: EKRA and the anti-kickback statute

A mobile phlebotomy business often sits between patients, ordering clinicians and laboratories, and that position is exactly what referral payment laws look at.

EKRA. The Eliminating Kickbacks in Recovery Act, 18 USC 220(a), applies to services covered by a health care benefit program. It makes it a crime to knowingly and willfully solicit or receive any remuneration “in return for referring a patient or patronage to a … laboratory”, or to pay or offer remuneration to induce a referral of an individual to a laboratory or in exchange for an individual using its services. The penalty is a fine of not more than $200,000, imprisonment of not more than 10 years, or both, for each occurrence. “Laboratory” has the CLIA meaning (18 USC 220(e)(4)), and “health care benefit program” has the meaning in 18 USC 24(b), which covers private plans as well as government programs. EKRA is not limited to Medicare and Medicaid patients.

EKRA lists exceptions in 18 USC 220(b). The one for payments to employees and independent contractors applies only if the payment “is not determined by or does not vary by” the number of individuals referred, the number of tests or procedures performed, or the amount billed to or received from the health care benefit program (18 USC 220(b)(2)). A lab that pays a draw company per specimen it delivers, per patient it steers, or a share of what the lab collects on those patients is offering the kind of pay that exception does not cover.

Anti-kickback statute. For federal health care program business, 42 USC 1320a-7b(b) makes it a felony to knowingly and willfully offer, pay, solicit or receive remuneration to induce or reward referrals, with a fine of not more than $100,000, imprisonment of not more than 10 years, or both. The civil monetary penalties law adds a penalty of not more than $100,000 for each such act plus up to 3 times the remuneration (42 USC 1320a-7a(a)). That amount is adjusted for inflation each year; 45 CFR 102.3 lists $127,973 for 2025.

What OIG has said about specimen collection payments. In its June 25, 2014 Special Fraud Alert, OIG addressed labs that pay physicians, “either directly or indirectly (such as through an arrangement with a marketing or other agent)”, to collect, process and package patients’ blood specimens. It noted that these payments “typically are made on a per-specimen or per-patient-encounter basis” and that Medicare already pays for this work through the specimen collection fee and bundled payments. The alert is written about payments to referring physicians, but its reasoning about per-specimen pay from labs is a useful test for any draw service that takes money from a lab.

None of this means a lab can never pay a draw company. It means the pay should be for services actually needed, at fair market value, set in advance, and not tied to the number of specimens or patients the draw company sends. Have health care counsel review any lab contract before you sign it, and before you advertise a lab partner on your site. For how liaisons and account reps are paid, see our guide to physician liaison programs.

Paying for patients: marketers, referral partners and perks

The same laws apply in the other direction, when you pay to get patients. Arrangements to review with counsel before you start them:

Marketing agencies or call centers paid per booked draw for patients whose tests are paid by Medicare, Medicaid or a private plan. EKRA and the anti-kickback statute both look at whether pay varies with referrals.
Referral fees to home health agencies, assisted living staff or clinics that send you patients, including gift cards, meals or free draws for staff.
Free or discounted services to ordering clinicians, such as free draws for their self-pay patients in exchange for their insured referrals.
Patient incentives, such as a gift card for booking an insured draw.

Paying a flat, advance fee for advertising that reaches the public, such as search ads or a mailer, is a different structure from paying per patient delivered. Our guide to home health agency marketing covers relationships with agencies and facilities in more detail.

Booking forms and privacy

A booking form for a blood draw collects names, addresses, test orders and sometimes insurance details. Whether HIPAA applies to your business turns on the definitions in 45 CFR 160.103. A covered entity includes “a health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter”, such as an electronic claim. A health care provider includes “any other person or organization who furnishes, bills, or is paid for health care in the normal course of business”. The same section defines a business associate as a person who, on behalf of a covered entity, creates, receives, maintains or transmits protected health information for certain functions. Which of these describes you depends on how you bill and for whom you work, so ask counsel.

Either way, a booking page that reveals which tests a person ordered is sensitive. Be careful with tracking pixels and remarketing tags on booking and confirmation pages; see our guides to tracking pixels on practice websites and healthcare remarketing ads. Do not describe your site or your service as “HIPAA-compliant”; describe the specific safeguards you use instead.

Patient-facing claims: speed, comfort, credentials and service area

Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in commerce (15 USC 45(a)), and 15 USC 52 makes it unlawful to disseminate a false advertisement for devices or services, among other products. For a mobile draw service, the claims that most often need support are:

Result timing. “Results in 24 hours” depends on the lab and the test, not on you. Say how long delivery to the lab takes, and that result times depend on the test ordered and the laboratory.
Comfort. “Painless” is a promise about every draw. “Experienced phlebotomists” or “we take time with nervous patients” describes what you control.
Credentials. “Certified” or “licensed” phlebotomists should match a real credential each person holds. State rules on phlebotomist licensing differ; we did not read them for this guide.
Service area and hours. List the areas and hours you actually serve, and show same-day availability only if your schedule supports it. Our guide to house call practice marketing covers service-area listings and staff safety wording.
Test menus. If you list tests, make clear who orders them. A draw service does not decide what is tested, and a test that needs a clinician’s order should say so.

An example (made up)

This illustration is invented to show how the rules fit together. A home draw company’s website says “Our CLIA-certified lab delivers results in 24 hours” and “Medicare covers your home draw.” It is paid by one lab a fixed amount per specimen and pays a marketing firm per booked Medicare patient.

Fixes: the company is draw-only, so the site now names its partner lab and says the lab, not the company, holds the CLIA certificate (42 CFR 493.2). Result timing now reads “we deliver your sample the same day; result times depend on the test and the laboratory.” The Medicare line now limits the travel fee to homebound patients and facility residents (42 USC 1395l(h)(3)(B)). On counsel’s advice, the lab contract moves to a fixed monthly fee for scheduled courier and collection services at fair market value, and the marketing firm moves to a flat monthly fee for ads, so neither payment varies with specimens or patients (18 USC 220(b)(2); 42 USC 1320a-7b(b)).

Checklist

No “our lab” or “CLIA-certified” unless you hold a CLIA certificate (42 CFR 493.2, 493.3).
On-site tests listed only if your certificate covers them; waived-test mobile units may use the home-base certificate (42 CFR 493.35(b)(1)).
Partner lab named accurately, its certificate checked, and the page updated if you change labs.
Medicare wording limits the travel fee to homebound patients and non-hospital inpatients (42 USC 1395l(h)(3)(B)); biller has confirmed coverage wording.
Self-pay prices show travel or convenience fees up front.
No pay from a lab that varies with specimens, tests, patients or amounts billed (18 USC 220(b)(2)); lab contracts reviewed by counsel.
No per-patient fees to marketers, facilities or clinicians for insured referrals without counsel review (18 USC 220; 42 USC 1320a-7b(b)).
HIPAA status worked out under 45 CFR 160.103; no tracking or remarketing tags on booking and confirmation pages without review.
No “HIPAA-compliant”, “painless” or fixed result-time promises; credentials and service areas accurate.

How we help

We build service pages, booking flows and local search listings for health businesses, with claims about labs, Medicare and partners checked against the sources above: website design, healthcare SEO for local service-area searches, and lead generation campaigns priced as flat fees, not per patient. We do not give legal opinions on CLIA status, Medicare billing, referral arrangements or state licensing, and we are not a law firm.

Does a mobile phlebotomy service need a CLIA certificate?

Not if it only collects or prepares specimens and does no testing. 42 CFR 493.2 says facilities that only collect or prepare specimens, or only serve as a mailing service, are not laboratories. If you perform any test on site, 42 CFR 493.3(a) requires a certificate covering the tests you perform, and a waived-test laboratory that moves between sites can be covered under its home base certificate (42 CFR 493.35(b)(1)).

Can we advertise that Medicare covers home blood draws?

Only with the limits in the statute. 42 USC 1395l(h)(3) provides a nominal collection fee and a separate travel fee, and the travel fee applies only to individuals who are homebound or inpatients of a facility other than a hospital. Coverage of the test itself depends on Medicare’s own criteria, so confirm wording with your biller.

Can a lab pay us per specimen we deliver?

That is the pay structure federal law looks at most closely. EKRA’s exception for employees and contractors applies only if pay does not vary with the number of individuals referred, tests performed or amounts billed (18 USC 220(b)(2)), and OIG’s 2014 Special Fraud Alert describes per-specimen collection payments from labs as suspect. Have counsel review any lab arrangement.

Does EKRA apply if our patients are all privately insured?

It can. EKRA covers services paid by any health care benefit program, which 18 USC 24(b) defines to include private plans and contracts as well as government programs. It is not limited to Medicare and Medicaid.

Can we say our booking site is HIPAA-compliant?

We recommend against it. Whether HIPAA applies depends on the definitions in 45 CFR 160.103 and on how you bill and whom you work for, and “compliant” is a broad claim. Describe the specific safeguards you use instead.

Sources

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Mobile phlebotomy marketing: CLIA, Medicare, EKRA and privacy rules