MEXICO CITY – Mexico is updating its medical device classification process, allowing the deregulation of more than 2,000 products considered low risk. The country’s Federal Commission for Protection against Sanitary Risks (COFEPRIS) said that by deregulating the lower-risk devices, it will be able to focus on enabling earlier access for innovative devices. The announcement marks the third deregulatory listing for medical devices, following the deregulation of 1,669 in the first stage and 573 in the second stage, according to BMI Research. The revised device classification is a move toward harmonization with international standards. Mexico is the leading exporter of medical devices in Latin America, and it ranks eighth internationally, according to COFEPRIS.
WASHINGTON – Telehealth industry leaders are applauding President Trump for signing into law a bill that includes the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act.
S.870 will accomplish several goals of telehealth advocates, including: expanding telehealth options for people enrolled in Medicare Managed Care plans; giving Accountable Care Organizations more freedom to use telemedicine; allowing a patient’s home dialysis facilities to count as a recognized originating site for telehealth visits; and expanding the use of virtual care for stroke patients.
“The passage of CHRONIC means more options and flexibility for both providers and patients, including better access to lifesaving treatments, tailored care for beneficiaries coping with multiple chronic health conditions, healthier patients and lower health care costs,” said Gary Capistrant, chief policy officer of the American Telemedicine Association, in a press release.
The act was part of a spending bill that was passed by Congress following a five-hour government shutdown on February 9. It was introduced last May by Sen. Orrin Hatch, R-Utah.
The act also expands and extends the Independence at Home Demonstration of the Centers for Medicare & Medicaid Services. The demo allows seniors with multiple and complex chronic conditions to receive specialized care at home from health care providers.
In a letter jointly signed by health groups like the Alliance for Connected Care, the American Heart Association, the Connected Health Initiative and the Personal Connected Health Alliance, industry leaders urged the signing of the act.
Citing the “significant body of evidence demonstrating that telehealth can reduce costs, improve outcomes and expand access to care for seniors,” the groups wrote that “now is the time to act to ensure that seniors are able to realize the benefits of digital technologies to manage their health care.”
WASHINGTON – The U.S. Department of Agriculture Rural Development has awarded more than $4.5 million in grants for telehealth projects involving virtual physician visits, remote patient monitoring, chronic health management and telestroke.
The grants were part of more than $23 million in Distance Learning and Telemedicine Grants to organizations and agencies in 29 states to improve access to telehealth for rural and underserved areas, and to establish distance learning programs.
The Oneida-Lewis Chapter of The Arc, a nonprofit human-services agency that provides advocacy and services for people with intellectual and developmental disabilities in New York, received a grant of $474,258 for its Non-Virtual Individualized Telehealth Experience, which uses video technologies to deliver health care.
“This will help us eliminate existing barriers to quality health care for people living in rural areas,” said Karen Korotzer, CEO of Arc Oneida-Lewis.
The grant will be used to purchase telemedicine equipment to connect a hub in Utica with 25 residential and day service sites in Oneida and Lewis counties. The investment will provide access to specialized medical professionals and services, as well as eliminate travel from rural areas to urban medical centers. The NVITE project serves about 2,500 individuals with disabilities, said Korotzer.
The University of Alabama at Birmingham received a $495,000 grant to expand its telehealth network to hospitals and medical centers across the state by purchasing videoconferencing technologies, connected medical devices and other infrastructure. The UAB plans to equip a total of 50 sites by the end of 2018.
Dr. Eric Wallace, medical director of telehealth at UAB, said technology like telehealth is critical to keeping rural patients connected with their caregivers without having to travel hundreds of miles for an office visit.
That thinking is in line with the motivations of the USDA in awarding the grants.
“Connecting rural Americans to quality health care services is an innovative and important tool in our efforts to facilitate economic growth, job creation and quality of life in rural America,” said Anne Hazlett, assistant to the secretary for rural development, in a statement.
‘This may open a whole new business model for telehealth’
CHICAGO – Patients in 29 states can now receive telehealth services from licensed nurses through an Enhanced Nurse License Compact.
The eNLC allows the recognition of nursing licenses between member states.
“This may open a whole new business model for telehealth,” said Candy Campbell, a registered nurse at the University of San Francisco School of Nursing and Health Professions.
Licensing standards are aligned in member states to ensure that all nurses applying for a multistate license are required to meet the same standards, which include a federal and state criminal background check.
Campbell believes the compact will help address the national shortage of nurses, especially in rural communities, through the use of technology.
“Allowing seamless entry from one state to another will certainly defray the shortage of nurses,” she said. “RNs and licensed, certified nurse practitioners can expect to have new opportunities to serve clients virtually.”
Dr. Latisha Rowe, founder of The Rowe Network, an online specialty medical group that provides telemedicine to patients around the world, said the eNLC will expand options for nurses to treat patients in their homes or other settings closer to home.
“The nursing compact will allow nurses to have more flexibility in supplying the needs of ‘health care deserts’ and to support multiple states virtually with video-based mobile apps,” she said.
eNLC member states are Arizona; Arkansas; Colorado; Delaware; Florida; Georgia; Idaho; Iowa; Kentucky; Maine; Maryland; Mississippi; Missouri; Montana; Nebraska; New Hampshire; New Mexico; North Carolina; North Dakota; Oklahoma; South Carolina; South Dakota; Tennessee; Texas; Utah; West Virginia; Wisconsin and Wyoming.
Legislation is pending in seven other states.
WASHINGTON – A bill headed to the President’s desk will help remove regulatory barriers to telehealth, allowing the Veterans Affairs to use technology to shift health care for veterans out of hospitals and into their homes.
Congress passed a bill last fall that removed a location requirement, paving the way for the VA to treat veterans anywhere in the country using telehealth technology. A similar bill passed this week in the Senate.
“This brings telehealth solutions to the forefront,” said David Shulkin, secretary of Veterans Affairs. “Whenever possible, our goal is to deliver health care to veterans in their homes, safely, because it’s in their best interest.”
The VA has developed a robust telehealth program, which includes home telehealth for veterans who have chronic conditions like diabetes, chronic heart failure, COPD and others. With “Anywhere to Anywhere VA Health Care,” which was introduced last fall, VA providers treat veterans anywhere in the country using telehealth technology, no matter where the provider practices. In the past, veterans using telehealth had to travel to a clinic to be seen by a provider at another clinic or facility.
Shulkin said the expanded access to telehealth will allow for an increase in remote patient monitoring and evaluations, which can be done in the home by health care professionals who use tablets and other devices.
As the barriers to telehealth are removed, Shulkin said the future is bright for veterans who want to live independently at home as they age.
“We’re able to integrate the use of technology with the ability to deliver care in person, and when you combine that with home visits, you start to develop an environment where you can care for veterans wherever they live,” he said.
WASHINGTON – Health experts are optimistic about the U.S. Food and Drug Administration’s guidance documents on digital health oversight released in December.
“These guidance documents take us one step closer to seeing a full integration of digital health into our lives,” said Kevin Madagan, a partner in Reed Smith LLP’s Life Sciences Health Industry Group.
The three guidance documents—two draft and one final—cover clinical decision support, changes to medical software policy based on congressional mandates in the 21st Century Cures Act, and Software as a Medical Device.
The draft guidance on clinical decision support, which has been six years in the making, clarifies which types of clinical decision support and patient decision support software the FDA defines as a medical device in need of agency oversight.
In a nutshell: Analytics technology intended to support clinical diagnoses that provides room for a physician to independently review the basis of the software’s recommendations would not be regulated by the FDA; however, software that analyzes medical images or laboratory or medical tests would remain regulated.
“This guidance, even in draft form, removes significant ambiguity,” said Madagan. “Until now, we didn’t know where the FDA would draw the line on CDS functions it would regulate, or whether they would ever agree to enforcement discretion for PDS.”
The other draft guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices. Among them: certain mobile apps.
“We’re making clear that certain digital health technologies—such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of the FDA’s guidance,” said Scott Gottlieb, FDA Commissioner, in a statement.
The final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.
Though the FDA guidance documents provide more clarity on digital health, Madagan said there is much work left to do.
“With advancements in digital applications being integrated into medical devices, and now even drugs, the digital oversight and real-time tracking of our health is just beginning,” he said. “And this doesn’t even account for the potential of artificial intelligence.”
WASHINGTON – The Federal Communications Commission’s repeal of net neutrality rules could have a big impact on home health care, according to several experts.
“Telehealth doesn’t work if you don’t have that connectivity,” said Mei Wa Kwong, interim executive director at the Center for Connected Health Policy. “It’s an essential element of telehealth and if you price people out, they aren’t going to be able to use it.”
The net neutrality rules, approved by the FCC in 2015, were intended to keep the Internet open and fair by prohibiting Internet service providers from speeding up or slowing down traffic from specific websites and apps. Under the repeal, the FCC would do away with those rules, as well as eliminate a rule barring ISPs from prioritizing their own content.
While experts fear that a repeal of net neutrality rules will negatively impact those who have been underserved by the health care system—low-income people and others—the FCC believes that lifting the ban on paid prioritization will spur innovation and ensure that health information will have priority over other Internet traffic. Bennett Ross, a partner with Wiley Rein LLP law firm, agrees.
“These apocalyptic claims are misguided,” he said. “Even if permitted to offer prioritization services, it is not clear that ISPs will actually do so.”
And if they do? Ross believes that health care is one industry that will actually benefit from the ability of an ISP to prioritize traffic because the quality and accessibility of medical care could be improved if medical service providers had the option to pay for priority services to make sure patient medical information is delivered quickly and reliably.
“The bottom line is that the FCC’s recent order removes heavy-handed regulation of the Internet, which allows the industry to innovate without government permission,” said Ross. “The health care industry should embrace, not fear, such innovations.”
MOUNTAIN VIEW, Calif. – HealthLoop, Wellpepper and Livongo are working with the Centers for Medicare & Medicaid Services to raise awareness of how patient generated health data and digital engagement tools can play critical roles in improving the quality of care and outcomes.
Executives from the three companies also participated in the CMS PGHD Round Table in Washington, D.C., this month to further the understanding of the value of PGHD in patient care.
“Patient generated health data is a valuable tool in patient care,” said Anne Weiler, co-founder and CEO of Wellpepper, a clinically validated platform for patient engagement that provides personalized, digital patient treatment plans delivered via mobile devices, SMS, email, web and interactive voice interfaces, in a statement. “We’re pleased that CMS has recognized this, and is enabling the collection and analysis to be used in demonstrating quality patient care.”
Beginning in 2018, physicians and other health care providers participating in the Merit Based Incentive Program of the Medicare Access and CHIP Reauthorization Act can qualify for reimbursement for using clinically endorsed digital health tools to remotely guide and monitor patients outside of the clinical encounter.
The new CMS MIPS Improvement Activity, entitled “Engage Patients and Families to Guide Improvement in the System of Care,” enables health care providers to be reimbursed for the remote monitoring, review and interpretation of patient generated health data gathered through clinically endorsed mobile patient engagement applications.
“This new rule is an important step forward for physicians and patients using digital engagement tools,” said Dr. Ben Rosner, CMIO of HealthLoop, a software solution that enables care teams to engage all patients before and after clinical encounters through automated daily check-ins, in a statement. “Financial incentives aside, engaging with patients is the right thing to do. Practices using automated patient engagement solutions see reduced readmission and complication rates, lower call center volume, better online ratings for physicians, and, most important, happier, healthier patients.”
Michael Sturmer, senior vice president of health services at Livongo, said the new rule will connect digital health with providers and care practices.
“It is a significant advancement in making digital health part of the fabric of the health care experience,” he said. “It is better for patients and providers, and that’s better for all of us.”
‘This change is a big step in the right direction’
BALTIMORE – The recent decision by the Centers for Medicare and Medicaid Services to expand reimbursement for telehealth is encouraging news for health care providers and a step in the right direction for its wider acceptance, experts say.
“It is definitely gaining steam,” said Gary Buss, associate vice president of Hoefer Wysocki Architects, which includes in its list of clients several clinics and health care facilities. “We are already seeing an increased interest in virtual consults, remote diagnostics, virtual sitters and a much more cost-effective solution for some home health monitoring. Additional funding will increase the adoption of these technologies.”
Beginning next year, CMS will increase support for health care providers who use remote monitoring tools and patient-generated health data to care for patients. The agency also created new codes to cover telehealth in lung cancer care, health risk assessments and chronic care management, among others.
Drew Schiller, CEO of health care data platform provider Validic, said remote patient monitoring programs faced challenges in the traditional fee-for-service world, with no mechanism for reimbursement for proactive care.
“This change is a big step in the right direction toward covering proactive RPM programs,” Schiller said.
Miranda Felde, vice president of patient safety at The Doctors Company, a physician-owned medical malpractice insurer, said CMS’s decision is good news not only for health care providers, but also their patients.
“The scalability of telehealth technology helps physicians and health care providers deliver value to patients,” she said. “Telehealth helps them provide direct and critical health care services by eliminating distance barriers, reducing delays in specialty referrals and improving patient convenience.”
SILVER SPRING, Md. – The U.S. Food and Drug Administration has announced the names of the companies selected to participate in its Pre-cert pilot program aimed at streamlining the agency’s approach toward digital health technology.
The pilot participants include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsun, Tidepool, and Verily.
“These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement.
The goal of the Pre-cert program is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to pre-certify it.
With the information gleaned through the pilot, the agency hopes to determine the key metrics and performance indicators for pre-certification and identify ways that pre-certified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program.
The FDA is also considering, as part of the pilot program, whether and how, pre-certified companies may not have to submit a product for pre-market review in some cases.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said Gottlieb. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.”
The FDA received interest in the program from more than 100 companies. In selecting the participants, the agency considered several factors including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product. The FDA’s selection process identified companies that represent different perspectives and unique approaches to digital health technology development.
“We are extremely appreciative of the tremendous interest in participating in the FDA Pre-cert pilot program,” said Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, in a statement. “The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health.”
As part of the Pre-cert pilot program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including ways they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system.
The FDA plans to share public updates about the Pre-cert pilot program via the pilot program webpage, as well as through stakeholder meetings, including a January 2018 workshop.