Choose an RPM device vendor by checking that each device meets the FDA section 201(h) device definition and is clinically accurate, that data arrives on enough days without patient effort (cellular usually beats Bluetooth), that readings flow into your EHR with alert tracking, and that the contract has a BAA, data export, and an exit if 2027 Medicare rules change.
Choose an RPM device vendor on four things in this order: whether each device meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act and is accurate enough for the clinical decision you will make; whether data actually arrives on enough days without patient effort; whether the data reaches your clinicians in a usable form; and whether the contract survives a change in Medicare rules. Software features come after those, and so does price.
Does the device qualify?
CMS requires the device used for RPM and RTM to meet the section 201(h) definition of a device (CY2024 physician fee schedule final rule). Ask the vendor for each device's FDA status, such as the 510(k) clearance number where applicable, and confirm it yourself in FDA's public databases. For blood pressure, look for devices validated for clinical accuracy; CPT's self-measured blood pressure codes use that phrase, and CMS proposed in 2026 to value RPM setup by reference to them. A consumer wellness tracker that is not a device in this sense will not support an RPM claim.
Will data arrive without patient effort?
Medicare RPM device supply depends on days of data: 2 to 15 days (CPT 99445) or 16 to 30 days (99454) per 30-day period. Connectivity drives those days more than anything else.
- Cellular devices transmit on their own once powered on. They suit older patients and patients without home internet. Ask which carriers and what coverage in your patients' ZIP codes.
- Bluetooth devices depend on a paired phone or hub. They cost less and fail more often when the phone is away, updated or replaced.
- Hubs can collect from several devices, which helps patients with more than one, but remember that only one practitioner may bill device supply per patient per 30 days regardless of device count.
Ask for adherence data from comparable programs: share of patient-months reaching 16 days, and how it changes after month three.
How does the data reach clinicians?
- Integration with your EHR, so readings and alerts sit in the chart rather than a separate portal.
- Configurable alert thresholds per patient, set by your clinicians, not defaults.
- A record of who reviewed each alert and when.
- Time tracking for the interactive communication and treatment management, with the communication itself logged.
- Reports by patient and by month that show all three RPM components, so you can catch the pattern OIG found in 43 percent of enrollees. See what OIG found.
Which contract terms matter?
- BAA. The vendor stores PHI for you; it needs a business associate agreement meeting 45 CFR 164.504(e).
- Data ownership and export. You own the readings; you can export them in a usable format at any time and at termination.
- Device logistics. Who ships, who replaces broken or lost devices, who handles returns at discharge, and what each costs.
- Term and exit. CMS's CY2027 proposed rule (91 FR 43842) would, if finalized, pay for RPM only when clinical staff are direct employees of the billing practice, and floated replacing current codes with four G-codes. Keep the term short or include a termination right tied to a change in Medicare payment rules. See the direct employee proposal.
- Service versus software. If the vendor also supplies nurses or care coordinators, separate that in the contract. Under the 2027 proposal, that service is the part most at risk.
Which pricing models deserve a lawyer's look?
Common models include a monthly fee per active device, a one-time device purchase plus software subscription, and a share of collections. A fee that rises with the number of Medicare patients enrolled, or a vendor that offers to recruit patients and run the program in exchange for a share of reimbursement, can raise federal anti-kickback questions under 42 U.S.C. 1320a-7b(b) and state fee-splitting issues. Patient-facing extras, such as gift cards for enrolling, raise beneficiary inducement questions. Have counsel review the model before you sign.
How should you run a pilot?
- Twenty patients across your actual demographics, for 60 days.
- Days of data per patient-month, by device type.
- Time from reading to alert to clinician review.
- Staff minutes per patient per month for management and outreach.
- Device failure and replacement rate.
- Patient complaints and drop-off.
Our RPM Program Setup ($5,950) includes vendor evaluation against these criteria; device and vendor fees are separate. See the RPM setup checklist and pricing.
Common questions
- Do RPM devices have to be FDA cleared?
- CMS requires RPM and RTM devices to meet the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act. Ask each vendor for the FDA status of every device, such as a 510(k) number where applicable, and confirm it in FDA's databases.
- Are cellular or Bluetooth RPM devices better?
- Cellular devices transmit without a phone, which usually means more days of data, especially for older patients. Bluetooth devices cost less but depend on a paired phone or hub and miss readings when that link breaks.
- Can an RPM vendor be paid a share of Medicare reimbursement?
- Percentage or per-enrollee arrangements, especially when the vendor also recruits patients, can raise federal anti-kickback and state fee-splitting concerns. Have counsel review any pricing model tied to Medicare volume or reimbursement before signing.
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