mHealth Reimbursement: An Urge or a Regulation
By Dr. Anu Banerjee, System Vice President, Chief Quality and Innovation Officer, Arnot Health And Dr. R A Ramanujan, Physician for Diabetic Care Associates, Arnot Health
mHealth reimbursement is a long pending urge that physicians are appealing CMS to consider. Today many mHealth and telehealth technologies are in place, but do not get reimbursed. The mHealth space in chronic care management is a fast-growing field, with diabetes care one of the larger platforms for innovation. Some mHealth technologies are in practice saving insurance companies and CMS millions of dollars. Endocrinologist Dr. R A Ramanujan, physician for Diabetic Care Associates and The Whiting Spring Hypertension Center, practices treatment methods that provide mHealth solutions to more than 2000 patients out of his 5000+ patients he sees in his practice. Dr. R A Ramanujan has been practicing since last 35 years, and has grown his practice with two other providers to more than 10000 patients. His daily routine consisted of seeing patients on a regular frequency to monitor their clinic blood pressure and modify their medications. Diabetes and hypertension are a silent killer in healthcare today and affects 28 million people in the United States (or 8 percent of the population) and accounts for roughly $245 billion in annual healthcare spending. It is certainly important to know that are there any mHealth technologies that has been approved for reimbursement. According to a study performed by mHealth news, Continuous Glucose Monitoring (CGM) systems may also provide cost savings to the healthcare system by preventing adverse events.
"The mHealth space in chronic care management is a fast-growing field, with diabetes care one of the larger platforms for innovation"
On interviewing, Dr.R A Ramanujan states “Patients now take ownership of their health. It is a cultural change for him to see that continuous monitoring and recording is getting a habit than a hobby.” In his contemporary practice, misdiagnosis of hypertension is very common due to poor standardization of in-office measurements. He adds “He has developed this innovative method of operation to treat his patients, and since then the Health coach sees and monitors over 100s of patients every day. He has also added new patients to this schedule. The time that any new patients or continuing patients had to wait has gone down as well. The patients have been better managing their chronic illnesses. The medication intake has improved, as well as the cost of office visit copays have decreased. One of his patients Carol W quoted “Prior to having the app, I started with a piece of paper, back of an envelope, anything on my kitchen table. Well, then it would get lost so I would have to start over or try to remember but when you are taking it 2,3,5,10 times a day that’s tough to do so I got a little smarter and started putting it in an excel spreadsheet. That was ok but I can’t lug my computer all over the place so I was back to a piece of paper on the kitchen table. The app for me is all encompassing and very easy to use, simple, clean, spot on.” Another patient Nancy C quotes “My vitals are read every day instead of me bringing them in every 2 months.”
Even if the physician currently does not get paid by any insurance companies the physician continues to sees his patients, continues to pay a Health coach to validate data entered by patients, and check on notifications created by abnormal readings. Studies note if reimbursement becomes a focus, then there would be clinicians for whom mHealth will become more prevalent. It also notes that reimbursement is one of the many barriers to overcome in the adoption of mHealth. Some of the major factors to make mHealth successful and sustainable are matter of culture, timing, process and sequencing.
The physician and the healthcare team faces challenges to see multiple patients with mHealth and this practice continues to maintain their health status. One of the biggest challenges is to convince the patients to use the smart technology and ensure that they are getting improved outcomes from their efforts to enter data.
Studies have proved that the challenges to convince patients that mHealth solution provides better outcomes, improve treatment and value compared to traditional services. The study also note that patients may consider paying a premium if time and effort is saved for better care. Value-based reforms are prompting health care organizations to 1) find more efficient ways to improve care while increasing quality; 2) expand care delivery outside the hospital and physician office; 3) facilitate patient-provider connectivity “anytime and anywhere”; and 4) increase patient engagement. Addressing privacy and security concerns, as well as reimbursement approaches and regulatory consistency across jurisdictions, should remove several existing barriers to adoption.
A recent study found that four in 10 U.S. hospitals have adopted telehealth (a broadly defined category which incorporates mHealth). Factors influencing adoption included market features (highly competitive, rural rather than urban), complexity of services, and regulatory oversight such as payment and licensure restrictions.
The U.S. FDA Guidance: Mobile Medical Applications Guidance issued by the FDA in September 2013, suggested that the FDA considers the following to be mobile medical apps subject to regulatory oversight: 1) Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purpose of controlling the device(s) or displaying, storing, analyzing or transmitting patient-specific medical device data. 2) Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens or sensors or by including functionalities similar to those of currently regulated medical devices. Such apps are required to comply with the device classification associated with the transformed platform. 3) Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient specific diagnosis or treatment recommendations. These types of apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.