The heady challenge facing the program was summed up by App Association President Morgan Reed, who attended workshops shaped around the pilot program earlier this year, in an interview with MobiHealth News:
"We have a situation where the manner in which the FDA is reviewing software is going to have to match the way our industry makes software, and so that was a big part of this discussion."
Another challenge and talking point regarding the program has been making it fair for companies of any size. The nine in the program span relatively small companies to IT and medtech giants, so it's understandable why this has been a source of discussion."
One goal of the pre-certification program was to set up a regulatory framework for software as a medical device so that companies with established, tried and tested quality assurance would be able to update their products faster. It puts the onus on the company and their quality control measures rather than focusing on each product update they execute.
The Group - led by by ACT | The App Association - noted that CMS had taken a step in the right direction with the 2018 Physician Fee Schedule by unbundling CPT 99091 ("physician/healthcare professional collection and interpretation of physiologic data stored/transmitted by patient/caregiver"). The action separated the code from more restrictive telehealth guidelines and enables, with "several limitations," providers to be reimbursed for collecting patient-generated health data through RPM platforms to monitor patients at home.
In the letter, the group is urging CMS to keep the unbundled code active, as well as "release and study related claims data that will yield important and unique insights on how these services are being employed."
At the same time that CMS unbundled 99091, the American Medical Association's CPT Editorial Panel approved three new codes that focus on RPM. The AMA has the sole authority to create CPT codes, though CMS doesn't have to approve reimbursement for them.
Morgan Reed, president of ACT | The App Association, stressed that remote patient monitoring isn’t just reimbursable, it’s potentially going to be one of the best ways for providers to get full value from MIPS.
“Under this program, if a physician requests that a patient provide them with patient-generated health data and then they review that data, that counts as an improvement activity under MIPS,” he said. “And why that’s important is this is the highest quality score for an improvement activity. It means money in their pockets through the bonus from the MIPS program.”
Reed said CMS expects a quarter of a million claims to be made under the new code next year. And the existence of the code will likely have trickle down effects for private payers as well.
“In short, the whole field of remote patient monitoring and patient engagement has had a chicken or egg problem,” Reed said. “We could build the software, but if it wasn’t economically or, from a liability perspective, good for the physician, they wouldn’t buy it. Physicians would request it, but if there weren’t enough physicians out there requesting it, than we wouldn’t build it. So the important part of what’s happened is it’s a marriage of the two aspects you need. The support from the physicians to make it worthwhile for them to buy our software, and that makes it worthwhile for us to write the code so they can start utilizing these capabilities.”
Of course there is further still to go for reimbursement, Reed said.
“The other thing that I think will need to be done is ensuring that for certain remote monitoring devices you can get a portion of the cost of those devices reimbursed through your HSA or FSA,” he said. “Right now you can go get your bottle of aspirin covered as long as your doctor writes you a prescription for it. If the physician writes you a prescription to say ‘I need to monitor your a-fib,’ you should be able to use your HSA or FSA to cover the cost of a remote patient monitoring device that you might wear on your wrist.”
Experts say that lack of clarity is holding back start-ups and big companies alike in their attempt to bring new technologies to health. That includes Apple's plans to use its smartwatch to detect irregularities with the heart's rhythm and notify users if they need a medical consultation.
"I know developers who sat in my office and told me they didn't build a life-saving feature because they didn't know if it would be regulated or not," said Morgan Reed, president of an app developers' interest group called ACT.
Three documents from the FDA remove some doubts by describing various types of medical software and what sorts of claims would be regulated.
Reed said it's now clear that if a doctor makes the decision and diagnosis, and uses software to make more informed decisions about treatment, that software would not be regulated.
It would be regulated, however, if the software makes a diagnosis. For instance, if it notifies a user that they have a specific medical condition.
Reed said this category of software is so important as it takes some of the guesswork out of medicine.
Morgan Reed, executive director of ACT | The App Association’s Connected Health Initiative, called the CDS guidance an “important first step” in providing a pathway for innovative tools to assist physicians.
“For years, our members have developed clinical and patient decision support software, but their solutions will not be adopted, nor their benefits felt, absent a clear regulatory framework,” Reed said in an emailed statement. “Today’s guidance focuses regulatory intent on the safety and effectiveness of software that independently analyzes patient data, rather than on software that supports doctors’ ability to use data to make treatment decisions."
The FDA also made several notable changes to the way it regulates mobile applications, as required under the 21st Century Cures Act. Through draft guidance, the agency proposed changes to previously published regulatory guidelines covering general wellness and mobile medical apps that pose a low risk for patients. The FDA also elected to move apps that allow patients to interact with ONC-certified EHRs out of its initial list of apps that require enforcement.
The final rule includes reimbursement changes suggested by the App Association’s Connected Health Initiative in February. A new improvement activity performance category, weighted as “high,” rewards physicians that leverage digital tools and devices that collect patient-generated health data including “patient engagement and outcomes tracking platforms, cellular or web-enabled bidirectional systems, and other devices that transmit clinically valid objective and subjective data back to care teams.”
CMS states that devices must use an “active feedback loop” to provide data in real or near-real time. A separate improvement activity category incentivizes providers to use remote monitoring tools like blood glucose logs or home blood pressure monitors fed through a certified EHR.
In an emailed statement to FierceHealthcare, Morgan Reed, the executive director of the Connected Health Initiative, said prior CMS regulations “created serious disincentives for doctors to consider using new technologies,” but the new rule offers an opportunity for innovators to collaborate with physicians.
“These new rules are an important step forward for America’s connected health innovators, doctors, and most importantly patients,” Reed said. “Until now, connected health technologies have been effectively locked out of the most important part of America’s healthcare system, Medicare and Medicaid.”
Read more here.
The rules drew praise from the Connected Health Initiative, which had lobbied CMS for RPM incentives this past February.
"These new rules are an important step forward for America’s connected health innovators, doctors and, most importantly, patients,” CHI Executive Director Morgan Reed said in a statement. “Until now, connected health technologies have been effectively locked out of the most important part of America’s healthcare system, Medicare and Medicaid."
“Previous CMS rules created serious disincentives for doctors to consider using new technologies,” Reed added. “Together with our advisory board, CHI pushed for newly enacted rules that finally level the playing field for innovators, giving doctors and patients the chance to take advantage of the best technologies available.”
Read more here.
Some, including Connected Health Initiative Executive Director Morgan Reed, were pleased with the changes. He praised CMS’ efforts regarding enabling doctors to utilize remote patient monitoring tools. In a statement, Reed noted:
These new rules are an important step forward for America’s connected health innovators, doctors, and most importantly patients. Until now, connected health technologies have been effectively locked out of the most important part of America’s healthcare system, Medicare and Medicaid.
Previous CMS rules created serious disincentives for doctors to consider new technologies. Together with our advisory board, CHI pushed for newly enacted rules that finally level the playing field for innovators, giving doctors and patients the chance to take advantage of the best technologies available.
Read more here.
CONNECTED HEALTH INITIATIVE
Senator Thad Cochran announced that the University of Mississippi Medical Center (UMMC) was awarded the U.S. Department of Health and Human Services’ Health Resources and Services Administration (HRSA) Telehealth Center of Excellence.
Morgan Reed, Executive Director of ACT | The App Association’s Connected Health Initiative shared the following praise for UMMC:
“We commend the UMMC Center for Telehealth for this well-deserved recognition. For more than a decade, the Center for Telehealth has been serving remote and underserved communities with their forward-thinking approach to telehealth. Telehealth solutions are not only vital to the treatment of chronic illnesses, but they also provide innovative means to improve patient outcomes and lower medical costs. We hope UMMC’s award serves as a signal for medical centers across the country to use telehealth to bring effective, low cost, high result healthcare solutions to the Americans who need them most.”
Read more here.
CONNECTED HEALTH INITIATIVE
Connected Health Initiative (CHI) Submits Letter for the Record at the Senate Finance Committee Hearing on the CHRONIC Care Act
CHI Executive Director Morgan Reed writes:
"We applaud your leadership in bringing forward the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017, which would take crucial steps to remove barriers to the use of telehealth, and we commit to work with you to move the country towards a more efficient and effective healthcare system."
"We urge you to consider further opportunities to improve the lives of countless Americans with chronic conditions by leveraging connected health innovations. Specifically, we urge you to consider incorporating key provisions of the recently reintroduced Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, which has been spearheaded by Senators Schatz, Wicker, Cochran, Thune, Cardin, and Warner, into the CHRONIC Care Act. The CONNECT for Health Act provides a carefully-crafted approach to helping countless Medicare recipients realize the benefits of connected health technology by lifting arduous limitations on the use of telehealth, as well as empowering Medicare physicians to utilize remote monitoring technologies."
To read the full letter, please click here.
CONNECTED HEALTH INITIATIVE
Statement by Morgan Reed on Senate Reintroduction of the CONNECT for Health Act
Representing leaders from across the connected health ecosystem, ACT | The App Association’s Connected Health Initiative (CHI) supports the Senate’s reintroduction of the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, led by Senators Schatz, Wicker, Cochran, Thune, Cardin, and Warner. CHI Executive Director Morgan Reed issued the following statement:
“The CONNECT for Health Act provides a carefully-crafted approach to begin helping countless American Medicare recipients realize the benefits of connected health technology. By lifting arduous limitations on the use of telehealth and empowering Medicare physicians to utilize innovative remote monitoring technologies, responsible and secure connected health solutions may be introduced more broadly throughout the continuum of care to improve patient health outcomes.
“We support the CONNECT for Health Act, and will work to address remaining issues in the path forward. CHI will continue to work to ensure the American healthcare environment is one in which innovative technologies, both available and in development, can reduce costs and improve healthcare for all Americans.”
May 3, 2017
CONNECTED HEALTH INITIATIVE
May 8, 2017
CONNECTED HEALTH INITIATIVE
Statement by Executive Director Morgan Reed on Senate Reintroduction of the CHRONIC Care Act
Following the Senate’s reintroduction of the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act (S.870), Morgan Reed, executive director of ACT |The App Association’s Connected Health Initiative, issued the following statement:
“The Connected Health Initiative (CHI) applauds the Senate Finance Committee’s decision, under the leadership of Senators Orin Hatch, Ron Wyden, Johnny Isakson, and Mark Warner, to reintroduce legislation for the CHRONIC Care Act. We have long advocated the important role healthcare technologies can play in treating the most debilitating illnesses in the most vulnerable populations.
“The reintroduction of this act is a step in the right direction to incorporate telehealth solutions into the treatment of chronic illness, specifically strokes, and help Medicare leverage the use of innovative technologies to improve patient outcomes and lower medical costs. However, Congress has more to do to bring the benefits of connected health technologies to more Americans, including improving the use of remote monitoring in community health centers and rural health clinics.
“Connected health technologies are vital components in the success of our country’s healthcare system, and we will continue to work with Congress to support an environment where more telehealth solutions may be used to improve care for more Americans.”
April 6, 2017
Congress to Revisit Telehealth for Chronic Care Legislation
“The reintroduction of this act is a step in the right direction to incorporate telehealth solutions into the treatment of chronic illness, specifically strokes, and help Medicare leverage the use of innovative technologies to improve patient outcomes and lower medical costs,” CHI Executive Director Morgan Reed said in a statement.
“However, Congress has more to do to bring the benefits of connected health technologies to more Americans, including improving the use of remote monitoring in community health centers and rural health clinics,” Reed added.
A group formed by ACT | The App Association has proposed a definition of 'asynchronous' telehealth, in hopes of settling debates over how it is regulated and reimbursed. Read more.
BECAUSE DEFINITIONS MATTER IN HEALTH CARE: Telemedicine is a field still coming of age; people still argue that telehealth and telemedicine are different things. More nuanced terms like "store and forward" are even squishier. Does it include sending data collected by blood glucose monitors to be analyzed by a nurse? Do self-reported medical histories count? It matters because state regulators need to police what's good and bad telemedicine practice and insurers need to know what they must pay for - and not.
- The Connected Health Initiative - a group of telemedicine-minded individuals convened by ACT | The App Association - is out with its own proposed definition of "store and forward" or "asynchronous" telemedicine: "the sharing of data from one party to another through the use of a device or software that records, stores, and then sends such data via any communications or technological means.
- The group's paper, which includes five use cases, comes as the American Medical Association is working to update its CPT coding system with telemedicine services.
Politico Morning eHealth
TIME TO TURN IN YOUR HOMEWORK: Responses are due today on CMS’s request for information on implementing policies required by the Medicare Access and CHIP Reauthorization Act. Early birds filed their comments Monday. They included the American Medical Informatics Association, which urged CMS to supplant existing process-based measures with more outcomes-based measures. A coalition of telehealth advocates, including ACT | The App Association, called for including “remote monitoring of patient generated health data” as a subcategory of clinical practice improvement activities, and urged Medicare remove telemedicine restrictions for doctors practicing in alternative payment models. Medical societies led by the American Medical Association called for the elimination of administrative burdens and better quality and reporting programs.
“Morgan Reed, executive director for ACT | The App Association, was among AirStrip's supporters.
‘We're proud to see AirStrip take to Apple's big stage today and demo its incredible technology for the Apple Watch,’ Reed said in a statement. ‘The apps take full advantage of the powerful sensors packed inside the Watch, providing doctors and patients with live data on vitals--from anywhere.’'
“Last week, Executive Director of ACT/The App Association Morgan Reed testified at a hearing before the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet on the future of the Internet of Things--and spoke to committee leaders about the promise the technology holds for healthcare.
ACT's primary goal, Reed said, was to help Congress understand the promise IoT offers. He wants to make sure congressional leaders don't think it's all about having a ’refrigerator on the Internet’--which Reed noted ‘misses just how powerful all of these connective devices can be for helping us live our lives with more control and less waste.’'
Mobi Health News
“Reed, meanwhile, focused his talk entirely on the mobile health segment, describing how, in the future, ’rather than a yearly update on one’s vitals in a doctor’s office, sensors will empower people to share it with a care team, have it incorporated in a cloud-based health record, or shown on a dashboard app in just a few taps.’ Services like Microsoft HealthVault, Apple Health, and Apple ResearchKit are already moving in that direction, he said. Yet as of now, few doctors are willing to prescribe these tools to patients, because of regulatory uncertainty.
‘Questions about privacy, security, reimbursement, and government regulation meet to create an environment where companies are worried about making devices more medically relevant, and physicians worry about the impact on their practices,’ Reed said. ‘Patients and care providers must also know that their information is private and secure. Industry best practices around the treatment of sensitive health data, as well as a commitment from government to support these practices, are important to establish trust and push this industry forward.’'
“There are 50 million definitions out there for eHealth,” jokes Brian Scarpelli, the ACT’s senior policy counsel and a CHI member. More importantly, he says, “there are conflicting messages” within state and federal agencies that affect how eHealth, mHealth, digital health, connected health, telehealth, telemedicine and all those other terms are used.
“It can get very confusing,” adds Alexandra Cooke, a tech policy professional with ACT and fellow CHI member. “In some cases it’s not the word itself [that is confusing], but how it applies to healthcare or how it’s used.”
2014 Fierce Healthcare
The letter also comes on the heels of a new ACT-The App Association report, released in part this week, regarding the mobile app industry which the report states has become a $68 billion industry in only six years, with current revenues expected to hit $4 billion this year and $26 billion in three years. The exponential growth is driving huge job creation, states the report, with 56 percent of app developer companies currently hiring. There is an average of 19.8 openings needing to be filled at those hiring businesses, according to the report.
ACT's Executive Director Morgan Reed said his group is pleased lawmakers are responding so quickly to its requests and are strongly committed to mHealth innovation.
“‘Apple is leaving your HealthKit data on the device and not collecting it,’ said Morgan Reed, executive director at The App Association, a Washington, D.C., nonprofit that works with patient advocates and app developers.
According to Reed, this prevents third-party app developers from selling your health data without your consent.
‘It also means that if an employer wants access to your health care information, they would have to demand that you give it to them,’ he said.”
"But selling wearables as medical devices comes with strings attached.
‘It would be far easier for a product like this to remain in the 'wellness' category,’ said Morgan Reed, executive director at The App Association, a Washington, D.C., nonprofit that works with patient advocates and app developers.”
Politico Morning eHealth
MOBILE HEALTH ON TAP AT THE WHITE HOUSE: ACT, the App Association, brought tech entrepreneurs to the White House Monday to demonstrate mobile health and talk about privacy law. Morgan Reed, executive director of ACT, said his group introduced small businesses driving the mobile health industry to senior White House staffers. “A big part of the discussion was the continuing need for HIPAA to not be a barrier, and how to get incentives realigned,” Reed said. Travis Bond, CEO of CareSync, a startup that gathers medical records in an online portal for patients to access and bring to their doctors on mobile apps, demonstrated the app’s functionality for White House staffers. It was “well-received,” Bond said. Reed and Bond talked with staffers about the ways HIPAA can be used to encourage access to patient records. “Normally we say HIPAA gets in the way, which it does from time to time,” Reed said. Mobile health groups including CareSync, Airstrip and CARES will accompany ACT to brief Senate HELP staffers on interoperability, mHealth and HIPAA today, Reed said.
The privacy developer guidelines that do exist are outdated, said Morgan Reed, director of The App Association, which represents some 50,000 app developers and IT companies.
And hospitals, being extremely risk-averse, will not do business with partners whose technology might not be compliant, making it hard for startups to win new business.
Reed: “Often we talk to developers who have got their first round of funding. They have a good idea that promotes good patient outcomes, but then they get into the development cycle and the sales just aren’t there. There’s a disconnect.”
To begin to address the lack of guidelines, the Office of Civil Rights says it has already held several meetings with The App Association.
Politico Morning eHealth
“Morgan Reed, executive director of the App Association, said the agency had provided ‘much-needed clarity’ around several issues related to cloud computing. But his group would still like clarity in other areas — the agency, Reed said, added some new terms that aren’t quite filled in yet.
NOTES FROM ACT: Your correspondent and his Politico colleagues took a visit to the group’s offices Thursday morning, and wanted to pass on a few notes from our discussion:” …….