Wellness device companies can make significant revenue from cash payments. But depending on such payments can artificially limit a company’s growth. If your device addresses a genuine medical need, it may be able to obtain insurance coverage and reimbursement, which enables far more individuals to benefit from the device.
A requirement for obtaining coverage is to identify the correct medical billing code for your device. Medical billing codes have strict requirements that must be met fully, as we discuss here. It is trickier than it might appear to match a wellness device to a medical billing code, but some devices have succeeded.
Close but no cigar: codes that wellness devices struggle to meet
There are CPT codes like 99454 for remote physiologic (e.g., weight, blood pressure, heart rate) monitoring, which may sound like they fit certain wellness devices. But CPT code 99454 has strict requirements. It can be used only if all the following requirements are met:
1. The device is a medical device as defined by the FDA
2. The services were ordered by a physician or other qualified health care professional
3. The services include supply of the device
4. The device must provide daily recordings or programmed alert transmissions for at least 16 days in a 30-day period
That is, the code requires the device to be regulated by FDA and track objective parameters specifically ordered by a clinician to manage a condition or disease such as congestive heart failure or severe respiratory disease. Collecting lifestyle metrics for consumer curiosity or general wellness optimization does not meet these requirements.
Wellness devices that have successfully obtained codes
This is not to say that a wellness device cannot obtain medical billing codes. Wellness devices can and have qualified for CPT and HCPCS codes when they are shown to address a particular disease or condition and meet all requirements of the code.
For example, Apple Watches and Fitbits can support reimbursement under CPT code 93040, which is for a rhythm electrocardiogram with interpretation and report. The code requires a clinician to order the test based on an event supported by documentation in the patient’s medical record (such as palpitations, chest pain, or shortness of breath) to help diagnose the presence or absence of arrhythmia. The clinician must also interpret the test results and provide a signed, written report. These requirements can be met when an individual presents to a clinician with symptoms such as palpitations or suspected arrhythmias, the clinician orders rhythm monitoring using the Apple Watch, and the clinician interprets and reports on the results.
Similarly, continuous glucose monitors can be used not only for general metabolic optimization, which retail buyers still need to pay out-of-pocket for, but also as reimbursable biosensors under HCPCS code E2103 (for nonadjunctive continuous glucose monitors or receivers) or CPT code 95250 (for continuous glucose monitoring with equipment that a clinician provides, manages, and trains the patient to use). The differentiator is clinical purpose: when prescribed by a physician to actively guide therapeutic decisions and replace routine fingerstick testing for patients with diagnosed diabetes or metabolic dysfunction, the sensor can qualify for a medical billing code.
How can the HcFocus team help?
HcFocus takes clients from strategy through execution, with decades of experience in market access and deep payer relationships. We work closely with innovators to obtain payer coverage and maximize reimbursement for medical technology, including medical devices and laboratory-developed tests. Reach out to schedule a strategy call.