New Senate bill seeks to reduce restrictions on telemedicine use

While the Senate’s efforts to repeal and replace the Affordable Care Act imploded last week, that hasn’t stopped lawmakers from introducing bills that would make tweaks to the healthcare system in smaller ways. One such bill, sponsored by Reps. Doris Matsui, (D-California), and Bill Johnson, (R-Ohio), would expand the use of telemedicine to reduce costs.

The bill, the Evidence-Based Telehealth Expansion Act of 2017, was introduced late last week and would give the Health and Human Services secretary the authority to waive Medicare restrictions on the kinds of telemedicine it covers — as long as the actuary at the Centers for Medicare and Medicaid Services concludes it would indeed save money.

Restrictions that would be lifted include any geographic limitations, as well as limitations on the use of store-and-forward technologies. Store-and-forward technologies are where patient healthcare data and digital images — such as radiologic images — are captured, packaged as a case file, and transferred via telecommunication services to a clinician who then responds with a diagnosis and any relevant therapeutic recommendations.

Additionally, the bill seeks to lift limitations on the types of healthcare providers who can offer these sorts of telemedicine services, with the caveat that they be a Medicare-enrolled provider. The bill would also remove limitations on on specific codes designated as telehealth services.

The waivers would come with certain restrictions. In addition to the CMS actuary rubber-stamping the waivers’ net reduction in spending, the HHS secretary would have to determine that the waivers reduce spending without reducing the quality of care; improve care quality without increasing spending; and wouldn’t deny or limit the coverage or provision of benefits for any given individual.

According to Politico, neither Republicans or Democrats see much chance in big telemedicine changes being attached to larger bills, such as the CHIP reauthorization act slated for later this year, but they remain open to opportunities.

High-tech vest that measures lung fluid could benefit those with heart faiure

Doctors at The Ohio State University Richard M. Ross Heart Hospital are testing a high-tech vest which measures fluid inside the lungs from outside a person’s clothing. It could potentially be a new way to prevent repeated trips to the hospital for the nearly six million Americans living with heart failure.

The SensiVest, created by Sensible Medical, uses radar technology that was first used by the military and rescue teams to see through walls and rubble in collapsed buildings.

“Now the technology has been miniaturized and put into a form that allows the radar to go through the chest wall and get an accurate measurement of water inside the lungs,” said Dr. William Abraham, director of the Division of Cardiovascular Medicine at Ohio State Wexner Medical Center. “With heart failure, the heart isn’t strong enough to keep up with the body’s needs and fluid stays in the lungs. Too much fluid makes it hard to breathe.”

Until now, cardiologists hadn’t concocted a non-invasive way of proactively monitoring for fluid changes. The M.O. has generally been to rely on patients weighing themselves daily and reporting symptoms such as swelling or shortness of breath. By then, it could be serious enough to require treatment in the hospital.

“We’ve learned these methods don’t catch the disease progression early enough, and that’s why hospitalization and rehospitalization rates for heart failure have changed very little in the last 20 to 30 years,” said Abraham.

Doctors are testing the vest in a national, randomized clinical trial to see if it effectively monitors and manages lung fluid, reduces hospitalizations and improves quality of life. Abraham leads the trial that includes approximately 40 sites across the country.

All patients enrolled in the trial receive a high standard of care for heart failure. Those randomized to the treatment group will also use the lung fluid monitor at home to take daily readings. The vest is worn over clothing and a reading takes about 90 seconds. The data is then uploaded to a secure server, where the patient’s cardiologist or nurse can review it.

Doctors can then use that data to see when the lungs are trending toward being too wet, and make adjustments to the medication on an outpatient basis or over the phone. The goal is to keep the patient within a normal range — and out of the hospital.

A previous (and small) observational study compared hospitalizations before and after using the vest. That study showed an 87 percent reduction in heart failure hospitalizations with vest lung fluid monitoring.

Patients in the trial will be followed for up to nine months.

FDA roundup: Dictum Health, Philips, Osprey Medical, VitalConnect

Over the last month, several digital health companies have wound their way through the FDA clearance process. Although the details on some of these clearances are still emerging, the following is a snapshot of some of what the agency has been up to.

Dictum Health’s telemedicine platform

Dictum Health, which makes an end-to-end telehealth platform, receieved clearance to add spirometry to the capabilities of its “virtual exam room,” which can already handle Sp02, blood pressure, height and weight, temperature, and ECG. The device takes the form of a tablet that connects to a variety of health device peripherals and it is cleared for use both in hospitals and in the home. Through the tablet, patients and doctors can conduct a secure, HIPAA-compliant video visit and beam vitals data directly to the clinician.

Founded in 2013, Dictum now operates in hospitals (including an ongoing pilot at UC Davis), schools, and skilled nursing facilities. The company received its original Class 2 clearance in 2015. Spirometry will allow the device to be used in monitoring and diagnosing chronic respiratory conditions like asthma and COPD.

Philips’ eCareCoordinator

Philips received an additional FDA clearance for eCareCoordinator, a telehealth application that was originally cleared in October 2014. With eCareCoordinator, clinicians can access daily summaries for each patient so that they can prioritize which patients to reach out to and what care plans they need to adjust. The app collects data from connected devices that measure health metrics including blood pressure, vital signs, and weight, but the app also gathers more subjective data from questionnaires and communication with the patient’s care team.

We’ve reached out to the company for more information on this particular clearance and we’ll update if they respond.

Osprey Medical’s DyeVert System

Osprey Medical is a company focused on a product called DyeVert, which helps reduce the risk of kidney damage to patients undergoing certain surgeries, including angiograms, stent placements, balloon angioplasties. Contrast dye is injected into patients’ bloodstreams to improve the effectiveness of X-Rays and CT scans. It’s safe for most patients but can cause problems in patients with kidney failure. Osprey’s DyeVert system uses a Bluetooth-equipped smart syringe and an associated monitor to track exactly how much dye is being used and halt the injection at a threshhold that could potentially harm the patient.

The DyeVert system recieved FDA clearance in March, but the company received another clearance for just the smart syringe component at the beginning of July. We’ve reached out to the company for details about the new clearance and will update if they reply.

VitalConnect’s VitalWatch

VitalConnect actually recieved this FDA clearance back in April, but the summary just became available. The remote monitoring company makes a disposable peel-and-stick health sensor called VitalPatch that can measure a range of biometric data including single lead ECG, heart rate, heart rate variability, respiratory rate, skin temperature and even posture (which can detect falls). Via Bluetooth, the sensors send the data to either a connected app or hub, then onwards to a cloud-based server where it can be accessed by the user’s care providers.

The new clearance is for VitalWatch, which is described as a software user interface that can serve as a secondary, adjunct monitor for VitalConnect data. According to the company’s trademark application, it seems likely that VitalWatch will be a mobile app.

The company declined to provide details, telling MobiHealthNews the clearance is part of a larger, upcoming announcement for the company, but did confirm that it is not an application for the Apple Watch.

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