Remote patient monitoring marketing rules

Remote patient monitoring lets a practice collect readings such as weight, blood pressure or pulse oximetry from a patient at home and use them to manage a condition between visits. Medicare pays for it under the Physician Fee Schedule, which means a practice that starts a program has to find the right patients, explain the service and get consent. The same service has also drawn attention from federal watchdogs, and the outreach that drew that attention resembles ordinary marketing: phone calls to people who are not patients, internet ads, and offers of a device. This guide covers what CMS says the service is, what CMS has proposed to change for 2027, how to describe the device, and how to invite patients without copying the patterns the government has warned about.

Several related topics have their own guides and are not repeated here. The consent conversation, cost-sharing wording, copay waivers and the federal telephone rules for invitations are covered in our chronic care management outreach guide, and the CMS booklet on that service says remote monitoring can be billed alongside it if time is not counted twice. Unsolicited calls to Medicare patients, purchased leads and third-party marketers are covered in our DME supplier marketing guide. Gifts and the wider beneficiary inducement rule are in our guide to marketing to Medicare patients, and the HIPAA test for patient messages is in portal messages and HIPAA marketing. Monitoring programs for heart failure patients are covered in heart failure clinic marketing.

This is general information, not legal or medical advice. Sources cited were checked on October 30, 2026: the CMS Medicare Learning Network booklet Telehealth and Remote Monitoring (MLN901705, December 2025), the CY 2026 Physician Fee Schedule final rule (90 FR 49266, published November 5, 2025), the CY 2027 Physician Fee Schedule proposed rule (91 FR 43842, published July 16, 2026; we found no final CY 2027 rule in the Federal Register on the check date), the HHS Office of Inspector General report Additional Oversight of Remote Patient Monitoring in Medicare Is Needed (OEI-02-23-00260, issued September 19, 2024), the OIG Consumer Alert on remote patient monitoring (last updated November 21, 2023), 21 U.S.C. 321(h), the FDA guidance General Wellness: Policy for Low Risk Devices (January 2026), 42 U.S.C. 1320a-7a and 1320a-7b(b), 45 CFR 164.501, 47 CFR 64.1200, 15 U.S.C. 45 and 52, and the FTC policy statements on deception and advertising substantiation. Medicare payment rules change each year, so check the current final rule before you publish.

What CMS says remote monitoring is

The CMS booklet uses the term remote monitoring for two code families: remote physiologic monitoring, which is what this guide calls remote patient monitoring, and remote therapeutic monitoring. Every invitation, web page and phone script should describe the service the way the booklet does, because a message that promises something different is describing a service the practice cannot bill. The booklet lists these requirements.

Remote physiologic monitoring requires an established patient relationship.
Only physicians and non-physician practitioners eligible to provide evaluation and management services can bill remote monitoring.
The practice must monitor an acute or chronic condition, and the monitoring must be medically reasonable and necessary.
Data must be collected for 2 to 15 days, or 16 or more days, out of 30, depending on the code. The CY 2026 final rule describes the new codes for fewer than 16 days of data and fewer than 20 minutes of interactive communication a month.
Only one practitioner can bill remote monitoring for a patient in a 30-day period, and remote physiologic monitoring and remote therapeutic monitoring cannot be billed together.
CMS requires patient consent at the time the services are provided.
Physiologic data must be collected electronically and uploaded automatically to a secure location where the billing practitioner can review it.
The device used to collect and send the data must meet the FDA definition of a medical device.
Auxiliary personnel can provide the services under the general supervision of the billing practitioner.

The booklet also describes three components, each building on the one before: patient education and device setup, device supply, and treatment management, which it describes as reviewing patient data to improve the patient’s health. That last component is the point of the service. A program that ships devices and collects readings without a clinician acting on them is not the service CMS describes, and it is the gap the OIG report focused on.

What CMS has proposed for 2027

In the CY 2027 Physician Fee Schedule proposed rule, published July 16, 2026, CMS proposed several changes that would affect how a practice starts and staffs a program. On the date we checked, the final rule had not been published in the Federal Register, so treat these as proposals and check the final rule before you build outreach around them.

An initiating visit: CMS proposed that the billing practitioner furnish a separately reportable face-to-face visit, in person or by telehealth, at the start of remote monitoring, and that if remote monitoring is not discussed at that visit, the visit cannot count as the initiating visit.
Established patients for remote therapeutic monitoring too: CMS proposed extending the established patient requirement to remote therapeutic monitoring.
Employed clinical staff: CMS proposed paying for remote monitoring only when the clinical staff providing it are direct employees of the practitioner or the practice, which it said would not allow contracting the service out to third-party companies, starting January 1, 2027 if finalized.

In explaining that last proposal, CMS cited OIG findings about companies cold calling Medicare patients to solicit them for monitoring they may not need. For marketing, the direction is plain: remote monitoring is meant to start inside an existing relationship, at a visit where the practitioner decides it fits, and not from an ad or a call that reaches a person first.

What OIG and CMS have flagged

The OIG report, issued September 19, 2024, found that use of remote patient monitoring in Medicare increased dramatically from 2019 to 2022 and that about 43 percent of enrollees who received it did not receive all three components. OIG recommended that CMS require remote patient monitoring to be ordered, with information about the ordering provider on claims, and that it identify and monitor companies that bill for it. OIG’s recommendation tracker showed four of the five recommendations still open on the date we checked.

The report and the OIG Consumer Alert describe the outreach pattern behind the fraud concern. The alert says unscrupulous companies sign up Medicare enrollees regardless of medical necessity, making contact through phone solicitations, internet ads or television advertising, and that billing for setup, teaching and monthly monitoring follows whether or not the monitoring happens. The report adds that CMS identified risks from companies cold calling enrollees without information supporting their need for a device, and from companies that provide devices without enough staff to monitor patients or train them.

A legitimate program can avoid looking like this by keeping a few lines clear in its marketing.

Invite your own established patients, chosen by their clinicians, rather than advertising the service to the public as something anyone can sign up for.
Do not ask for a Medicare number in an ad response, a web form or a first phone call. The OIG alert tells patients to be suspicious of anyone who offers free equipment and then asks for their Medicare number.
Do not hand outreach to a company that contacts people who are not your patients. The DME guide linked above covers the federal rule on unsolicited calls.
Make sure the treatment management component exists before you promote the program, with named staff who review readings and a practitioner who acts on them.

Describing the device

The CMS booklet requires the device to meet the FDA definition of a medical device. That definition, in 21 U.S.C. 321(h), covers an instrument, apparatus, machine or similar article intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, or intended to affect the structure or a function of the body. The FDA general wellness guidance, updated January 2026, draws the line from the other side: it says products are not general wellness products when they are intended to measure, estimate or report physiologic values for medical purposes, including monitoring of a disease or condition, and it lists blood pressure monitors and blood glucose measuring devices as examples.

Two marketing points follow. First, do not describe a consumer fitness tracker or a wellness app as part of a remote patient monitoring program unless the device the program actually uses meets the CMS requirement. Second, do not put FDA status words in patient copy. If a patient asks about a device, give them the manufacturer’s own labeling and let the clinical team answer, rather than writing your own description of what FDA has or has not done.

Device names and photos raise the same issue. We do not name device makers in our guides, and we suggest practices describe the device by what it measures and how the patient uses it, which is what the first component of the service, patient education and setup, is about anyway.

Free devices, cost and outside companies

The booklet treats device supply as one of the three components of the service, so the device is part of a billed service and not a gift. Ads that lead with a free blood pressure cuff or a free scale send the message the OIG alert warns patients about. Under 42 U.S.C. 1320a-7a(a)(5), offering remuneration to a Medicare or Medicaid beneficiary that the offeror knows or should know is likely to influence the beneficiary to choose a particular provider can bring civil monetary penalties. Describe what the program is and what it costs the patient, not what the patient gets to keep.

Remote monitoring is a Medicare Part B service paid under the Physician Fee Schedule, so before you write any cost wording, ask your billing team what a patient may owe under their coverage, and do not call the program free to Medicare patients. How to word cost sharing, and why waiving the coinsurance cannot be part of an enrollment offer, are covered in the chronic care management guide linked above, and the same reasoning applies here.

Outside companies are the other risk. The Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), makes it a crime to knowingly and willfully offer or pay remuneration to induce referrals of items or services paid by a federal health care program. A vendor that is paid per enrolled patient, or that pays the practice for each patient it signs up, needs a lawyer’s review before any outreach starts. If CMS finalizes the 2027 staffing proposal, a vendor that provides the monitoring staff may also stop fitting the billing rules, so check the final rule before you sign or renew.

Calls, texts and patient messages

An invitation from a practice to its own patients about a monitoring service the practice provides is a treatment and care coordination communication. The HIPAA definition of marketing in 45 CFR 164.501 excludes communications for treatment, case management and care coordination and descriptions of the provider’s own health-related services, unless the practice is paid by a third party to send them. If a device vendor pays the practice to send the message, that exception changes, and the portal messages guide linked above walks through the test.

Calls and texts follow 47 CFR 64.1200. Automated or prerecorded calls and texts to cell phones need prior express consent, and the health care message exemption has conditions of its own. The chronic care management guide sets out how those rules apply to enrollment invitations, including the FCC rule on revoking consent that takes effect November 25, 2026, and the same approach fits remote monitoring invitations.

Claims about the program

Claims about monitoring are claims about a health service, so they fall under 15 U.S.C. 45, which prohibits unfair or deceptive acts or practices, and 15 U.S.C. 52, which prohibits false advertisements for services. Under the FTC policy statement on substantiation, an advertiser needs a reasonable basis for an objective claim before making it. Under the deception statement, the test is the net impression on a reasonable consumer.

Monitoring hours: a phrase like round-the-clock monitoring describes staffing. Only use it if someone reviews readings at every hour you claim, and say what happens when a reading is out of range and when it is not.
Response times: if you state how fast the team responds to a reading, that is an objective claim. Keep the staffing records that support it.
Outcomes: do not promise fewer hospital visits, better control of a condition or any other result. That is a health outcome claim, and it needs competent evidence for that specific claim before it is made.
Emergencies: tell patients plainly that the program is not an emergency service and that they should call 911 in an emergency. Readings sent to a monitoring program are not a substitute for that call.

Illustration: one invitation and one web page

Illustration: a family practice decides to offer remote blood pressure monitoring. Its clinicians flag established patients with high blood pressure who they think could benefit, and those patients get a letter from their own practitioner saying the practice offers home monitoring, that the clinician would like to discuss it at the next visit, what the device measures, how readings are reviewed and by whom, what the patient may owe and who to ask about it, and that the program is not for emergencies. The letter does not ask for a Medicare number and does not offer a free device. The decision to start is made at the visit, where consent is taken and recorded.

Illustration: the same practice adds a page to its website that explains remote monitoring for existing patients. It describes the three components in plain words, names the role of the staff who review readings, states the hours readings are reviewed, says patients should call 911 in an emergency, and tells patients to ask their clinician whether the service fits. It has no sign-up form for the public, no device giveaway and no outcome promises.

Checklist

Every message matches the CMS booklet: established patients, an acute or chronic condition, medically necessary monitoring and consent.
Outreach goes to your own patients, flagged by their clinicians, not to the public or a purchased list.
No Medicare number is collected in an ad response, web form or first call.
Treatment management staff and hours exist before the program is promoted.
The device meets the FDA medical device definition, and copy uses no FDA status words.
No free device offers and no free program claims for Medicare patients.
Any vendor paid per enrolled patient has been reviewed by a lawyer.
The CY 2027 final rule has been checked for the initiating visit and staffing proposals.
Monitoring hours and response time claims are backed by staffing records, and no outcome is promised.
Every invitation tells patients the program is not for emergencies.

How we help

We build websites, local search, Google Ads and AI front desk tools for independent practices and health businesses. For a practice starting remote patient monitoring, that means a website page for existing patients that describes the service the way CMS does, invitation letters and phone scripts that send the decision to the visit, and inquiry flows that route questions about devices, readings and cost to the right person on your team without collecting Medicare numbers. 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. We do not sell lead lists and we do not pay for referrals. For the wider rules, see our healthcare marketing rules hub.

Can we advertise remote patient monitoring to the public?

The CMS booklet says remote physiologic monitoring requires an established patient relationship, so the service starts with your own patients. OIG has warned about companies that sign people up through calls and internet ads regardless of need, so outreach that sends the decision to a visit with the patient’s own clinician is the safer pattern.

Can we offer patients a free device?

The CMS booklet treats device supply as part of the billed service. Offering something of value to a Medicare beneficiary that is likely to influence their choice of provider can bring civil monetary penalties under 42 U.S.C. 1320a-7a(a)(5). Describe the program and its cost instead.

Does the monitoring device have to be a medical device?

Yes. The CMS booklet says the device used to collect and send the data must meet the FDA definition of a medical device in 21 U.S.C. 321(h). The FDA general wellness guidance says products intended to monitor a disease or condition are not general wellness products.

Can we use an outside company to run the program?

Under the current booklet, auxiliary personnel can provide the services under the general supervision of the billing practitioner. CMS proposed for 2027 that only clinical staff employed by the practice could provide them, so check the final CY 2027 rule, and have a lawyer review any per-patient payment arrangement under the Anti-Kickback Statute.

Can remote monitoring and chronic care management be billed for the same patient?

The CMS booklet says remote physiologic monitoring or remote therapeutic monitoring, but not both, can be billed concurrently with chronic care management and certain other care management services if time and effort are not counted twice.

Can we say the program reduces hospital visits?

Only with competent evidence for that specific claim. Under 15 U.S.C. 45 and 52 and the FTC substantiation statement, objective health claims need a reasonable basis before they are made. Describe what the service does instead.

Sources

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