Skip to main content
Monthly Archives

July 2021

Medicare Proposes New Changes for Telehealth Services in 2022

By News
Thomas (T.J.) Ferrante

Thomas (T.J.) Ferrante

Board Certified Health Law Attorney at Foley & Lardner LLP

Editor’s Note: This article is the third of a four-part series discussing specific telemedicine and digital health features in the 2022 Medicare Physician Fee Schedule proposed rule. Read part 1 of this series here and read part 2 here.

On July 13, 2021, the Centers for Medicare and Medicaid Services (CMS) released an advance copy of the calendar year (CY) 2022 Medicare Physician Fee Schedule (PFS) proposed payment rule, to be published on July 23, 2021. While the proposed rule introduces some new virtual care services (including Remote Therapeutic Monitoring), CMS rejected all requests to permanently add new telehealth services next year.

This article discusses: 1) the current state of Medicare telehealth services; 2) requests for new telehealth services; 3) extending the timeframe for Category 3 temporary codes; 4) a new permanent code for virtual check-ins longer than 10 minutes; and 5) whether CMS should continue allowing direct supervision via telemedicine.

Medicare Telehealth Services Post-COVID

Telemedicine and digital health technology is becoming an established part of medical practice and is very likely to persist after the COVID-19 pandemic. According to CMS data, before the Public Health Emergency (PHE), 15,000 Medicare patients each week received a telemedicine service. By April 2020, that number grew to nearly 1.7 million Medicare patients each week. Nearly half of all Medicare primary care visits in April 2020 were telehealth encounters, a level consistent with health care encounters more broadly. Between mid-March and mid-October 2020, over 24.5 million patients (approximately 40% of all Medicare patients) had received a telemedicine service. The data reveals how providers have begun to successfully integrate telemedicine into traditional health care delivery approaches.

The current list of Medicare-covered telehealth services includes approximately 270 services, with 160 services added on a temporary basis (including service categories such as emergency department visits, initial inpatient and nursing facility visits, and discharge day management services) and covered through the end of the PHE.

No New Telehealth Services Proposed For 2022

CMS received several requests to permanently add various services to the Medicare telehealth services list effective for CY 2022. Unfortunately, none of the requests met CMS’ criteria for permanent addition to the Medicare telehealth services list. The requested services are listed in the table below.

No alt text provided for this image

CMS found that the codes did not meet the criteria for addition to the Medicare telehealth

Virtual Access to Doctors During the Pandemic Changed the Lives of Patients With Disabilities. Now That Care Is in Jeopardy.

By News

Telemedicine opened up new possibilities for patients with disabilities and chronic conditions.

Three years ago, at age 14, my sister was diagnosed with a rare chronic connective tissue disorder. Her illness makes it extremely difficult—and sometimes dangerous—for her to sit up, walk, ride in a car, and do many other everyday activities. It also means that in order to receive treatment, she has to see specialists who live in other states two or more hours away from our small Vermont town. Even going to see her primary care doctors, ironically, means potentially jeopardizing her health in the process. “It feels like a risk/reward calculation every time we go,” she says.

The pandemic, despite all of its difficulties, did bring some blessings for her: All of her medical appointments shifted online and she was suddenly able to get the care she needed without the risk that going to the doctor would make her condition even worse.

While this shift to telehealth made health care easier and more accessible to everyone, it has had even bigger benefits for many people who suffer from chronic illnesses or have disabilities.

Kiki Christensen, who has suffered from a multi-system illness called Ehlers-Danlos syndrome for 45 years since the age of 10, was able to virtually access 13 new care providers—including two specialists who practice far away from her home in California—who helped her with the many multi-system side effects of her illness. She was also able to save energy during the pandemic by continuing to meet with her regular doctors virtually. 

“Telehealth enabled me to assemble the care team that I’ve always needed,” she says over email. “Instead of the energy deficit required to cross town in a car, I was able to see doctors at home. This enabled me to save enough energy and strength to continue daily at home physical therapy, and to access an online Qigong class that helps me very much. I was also able to knock out my migraines due to the experts at USC Keck. I never would have seen them if it was only in-person because I could not drive to Keck in the past.” 

This change has made a world of difference for Christensen. “I went to Disneyland with my cousin last month,” she says. “I totally shocked myself with how much strength I had gained.”

The broad access to telehealth across state lines was made possible by states waiving medical licensure requirements as a part of emergency orders during the pandemic. These made it possible for health care providers to have appointments with patients in other states.

Now that emergency orders are being lifted, the future of telehealth is unclear.

“One of the big benefits of what happened during the pandemic was an expansion, but it was also a sense of clarity,” said Ateev Mehrotra, a healthcare policy researcher at Harvard, in a late June symposium on telehealth. “We’re about to enter a time where it’s very, very confusing because everyone’s going to potentially have a different set of rules. And for a telehealth provider, that makes things 10 times worse because you have 10 sets of rules for every state you’re in.” 

Now, providers may have to give up their newer virtual patients or jump through a lot of hoops to keep them. And patients who were able to see doctors from the comfort and safety of their homes may have to again make those risk/reward calculations about whether it’s worth traveling to receive care.

The good news is that a number of organizations and states are taking measures to preserve the freedom of care that telehealth has enabled. 

The Interstate Medical Licensure Compact is an agreement among 30 U.S. states that streamlines the complex licensure requirements for medical providers who want to offer telehealth care across state lines. Eligible physicians can use one application to qualify for licenses from all participating states. A similar compact, Psypact, exists for mental health providers. 

Legislators in Connecticut, Arizona, and Delaware have recently passed bills that will allow out-of-state providers to continue to provide telehealth services to those in their states.

There are also two federal bills in progress in the House and Senate that aim to reduce barriers to telehealth. The Senate bill would remove all federal geographic requirements for digital health appointments. 

“Remote access to healthcare was suddenly available for all of us during the pandemic,” says Christensen. “It should have always been available, as soon as the technology permitted. Certainly, we can’t take it away now for the most vulnerable among us.” 

To Tackle the Digital Divide, A Program Teaches Seniors How to Use Telehealth

By News

A pilot program in South Carolina is addressing the digital divide by teaching seniors in rural counties how to use telehealth technology.

By Eric Wicklund

July 26, 2021 – A pilot program in South Carolina is tackling the digital literacy divide with a program that teaches seniors how to use telehealth technology.

Supported by the South Carolina Department on Aging and the national non-profit Rural Local Initiatives Support Corporation (Rural LISC), the program equips seniors in rural communities with a tablet and free cellular service for up to a year. The seniors attend classes on digital literacy at local community centers, building a comfort level with devices that are fast becoming a portal to connected health in underserved communities.

“It is our hope that this pilot program will be a model of one approach to closing the digital divide in South Carolina,” Kathy Schwarting, CEO of Palmetto Care Connections (PCC), told the South Carolina-based Statehouse Report.

PCC, a state-wide non-profit connected health organization that co-chairs the South Carolina Telehealth Alliance with the Medical University of South Carolina (MUSC), conducted the program, which involved roughly 100 seniors in rural Barnwell and Allendale counties. The pilot program will expand to three more counties soon, with hopes of becoming statewide.

“They loved it,” Schwarting said of the seniors, who learned how to use tablets not only for virtual visits with their care providers but also for communicating with family and friends, playing games and accessing other online resources.

Digital literacy – or a lack thereof – is considered a social determinant of health, and a considerable barrier to telehealth adoption in rural and remote parts of the country. People won’t use telehealth if they’re not comfortable with the technology, and if they can’t afford or access it easily, they have little opportunity to become familiar with it.

The shift to telehealth during the coronavirus pandemic cast the digital literacy gap in a harsh light, and prompted healthcare organizations and telehealth advocates – including the American Medical Association and the Telehealth Equity Coalition, launched this past February – to study how to address that gap.

“With the pandemic we’re creating a bigger digital divide,” says Luis Belen, CEO of the National Health IT Collaborative for the Underserved (NHIT), a public-private partnership launched in 2008 to engage underserved populations in the use of health information technology. “We need to start having conversations that focus on creating equity.”

Another health system tackling the divide is Jefferson Health. After receiving funding last year to expand its telehealth network to address COVID-19, the Philadelphia-based network created a task force to make sure those expanded resources would be used.

“You can’t just hand someone a device and expect they’re going to be on a telehealth visit the next day,” said Kristin Rising, MD, MS, an associate professor and director of the Center for Connected Care. “Many people aren’t comfortable using telehealth. You have to find out why … and help them.”

“Telehealth has the potential to decrease our digital divide,” she added. “But we need to know how to use it first.”

Source: mHealth Intelligence

NEW for 7/23: Pilot telehealth program for seniors; Tax reform

By News

These Allendale County seniors participated in the pilot digital literacy training recently.  On the back row are, from left, Enoch Robinson, Georgia Williams, Henry Singleton, Glinda Smith and Bernice Gill. In front are Jannette Bennett, Mamie Peeples, Geraldine Cohen, Helen Bowers, Mary Edwards and Lavonia Brodus. Photo via PCC.

By Al Dozier, special to Statehouse Report  |  For many seniors in rural areas, getting online is virtually  learning a new language.  But it could vastly improve their health.

Elderly residents in rural areas of Barnwell and Allendale counties recently completed a “literacy learning” program conducted by Palmetto Care Connections (PCC), a statewide, non-profit telehealth organization.

The program was part of a pilot project funded by the Rural Local Initiatives Support Corporation (LISC) and the S.C. Department on Aging to help 100 seniors who live in rural communities with digital literacy training. The program provides each with a free digital tablet plus a free cellular service for 12 months.

Participants took classes at a local senior citizens center where they were provided with the free digital tablet, something many have rarely used.  It’s that table-top device the grandkids are always playing with.

There was some doubt in the beginning about seniors taking on something like digital learning.  But PCC officials said the opposite was true.


“They loved it,” said Kathy Schwarting, CEO of PCC, which is located in Orangeburg.

Some of the participants gave positive comments about the class in a recent news release posted by PCC.

“I enjoyed the class, liked the people and could follow the instructions they gave,” said Leslie Dowling of Blackville. I learned about sending and receiving emails, which is something I didn’t know. It makes me feel real good.”

“I’m planning on using telehealth,” said Harry Singleton of Allendale. “It’s good to have the opportunity to talk to my doctor without having to go to his office.”

Helping seniors connect with health care providers was considered the most important issue, but Schwarting said the program also offered the opportunity to learn how to email friends and family, which was very important to many of the participants.  Some even learned how to play games on the computer.

Senior service organizations throughout the state are familiar with the program.

Shawn Hege, director of Senior Services at Generations Unlimited in Barnwell and Blackville, said: “This program was amazing—a great service to our seniors, especially those who need more interaction. Seeing their faces light up when they connected with family and friends was incredible.”

Soon after the first sessions were offered, Schwarting said many participants asked for longer sessions. Some wanted more classes. She said PCC agreed to those requests.

A statewide model?

The  accomplishments of the program promise change for the state, Schwarting said.

“It is our hope that this pilot program will be a model of one approach to closing the digital divide in South Carolina,” she said.

Seniors from Clarendon, lower Richland and Williamsburg counties are slated to complete the training in the coming weeks as part of the initial pilot program. PCC plans to expand the training for senior and underserved populations throughout the state.

PCC co-chairs the South Carolina Telehealth Alliance, along with the Medical University of South Carolina, serving as an advocate for rural providers and partnering with organizations to improve health care access and delivery for all South Carolinians.

Rural areas are always short-handed for medical needs, according to state officials. They typically have fewer health care resources than other areas — fewer physicians and other providers, fewer facilities and fewer hospitals, if there is one at all. When there is a hospital, it may have fewer, or less intensive, services.

That’s why PCC officials say “literacy learning” has become a critical need.

Ehrhardt Pharmacist Named 2021 Pharmacist of the Year

By News

Ehrhardt, S.C.–Ehrhardt Pharmacy owner and pharmacist Donna Avant, R.Ph., was recently named 2021 Pharmacist of the Year by the South Carolina Pharmacy Association in appreciation for exemplary leadership.

“Donna Avant is truly an extraordinary pharmacist,” said Kathy Schwarting, CEO of Palmetto Care Connections (PCC), a non-profit telehealth network headquartered in Bamberg, S.C. “Donna consistently goes above and beyond to serve the health care needs of Ehrhardt and the surrounding communities not only with prescriptions, but health screenings, chronic disease education and outreach.”

“In 2020, Ehrhardt Pharmacy partnered with PCC to offer telehealth services for their customers,” said Schwarting. “Bamberg Family Practice is currently providing telehealth visits to their patients at Ehrhardt Pharmacy, and Low Country Health Care System as well as S.C. Department of Mental Health plan to begin telehealth services at Ehrhardt Pharmacy soon. The telehealth program is just one example of Donna’s outside of the box thinking and dedication to helping her customers get the health care services they need. On behalf of the PCC Board of Directors and the PCC team, we congratulate Donna on the tremendous honor of being named South Carolina Pharmacist of the Year.”

A graduate of the University of South Carolina College of Pharmacy with a Bachelor of Science degree in Pharmacy, Avant has worked as a pharmacist for more than thirty-three years. Her work history includes pharmacist for Eckerd Drug in Walterboro, S.C.; Wal-Mart Pharmacy, filling where needed at various S.C. locations; Winn Dixie Pharmacy in Hampton, S.C., serving as district manager for more than 35 stores in three states; and pharmacist in charge at Wal-Mart Pharmacy in Barnwell, S.C.

In November of 2013 Avant became the sole owner and operator of Ehrhardt Pharmacy, LLC, a rural independent pharmacy in Ehrhardt, S.C. The pharmacy offers soda fountain with hand-dipped ice cream and home-made milkshakes, gift shoppe, home medical supplies, full-service pharmacy, and drive-thru. In addition, Donna and her staff provide a myriad of community services including: Summer children’s reading/crafting/lunch programs; HIV screenings; immunizations; blood pressure checks; hypertension counseling; free community vitamin program; and lifestyle change classes for individuals with diabetes and pre-diabetes.

For more information about telehealth at Ehrhardt Pharmacy contact the pharmacy staff at 803-267-2121.

Established in 2010, PCC is a non-profit organization that provides technology, broadband, and telehealth support services to health care providers in rural and underserved areas in S.C. PCC received the National Cooperative of Health Network Association’s 2021 Outstanding Health Network of the Year award.

PCC co-chairs the South Carolina Telehealth Alliance, along with the Medical University of South Carolina, serving as an advocate for rural providers and partnering with organizations to improve health care access and delivery for all South Carolinians.

Lawmakers Seek to Mandate Payer Coverage for Telehealth Services

By News

By Eric Wicklund

– Two Congressmen have re-introduced a bill that would prompt payers to cover any telehealth service that’s also offered in-person.

The bill, unveiled last week by US Reps. Dean Phillips (D-MN) and Steve Chabot (R-OH), joins a steadily growing pool of proposed legislation aimed at establishing long-term connected health policy in the wake of the coronavirus pandemic.

HR 4480 does not yet have attached language, nor have Phillips or Chabot issued a press release on the bill, but the description indicates it would “amend the Public Health Service Act to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for services furnished via telehealth if such services would be covered if furnished in-person.”

The two lawmakers had proposed similar legislation in September 2020, but that bill failed to make it through committee.

It aims to create a level playing field for providers looking to embrace telehealth, while sidestepping the issue of whether those services should be covered at the same rate as in-person services. Several states have enacted some version of payment parity as a means of supporting telehealth adoption, while some states and several payers have argued that payers should be able to negotiate their own reimbursement rates with providers.

Nearly $30 million in grants approved to expand broadband availability in rural SC areas

By News

The South Carolina Office of Regulatory Staff (ORS) has issued almost $30 million in grants for projects to expand broadband internet connection in rural areas.

The ORS has issued notice to proceed to 16 different internet providers in 22 counties across the state of South Carolina.

Projects were awarded to Aiken, Allendale, Bamberg, Barnwell, Beaufort, Berkeley, Calhoun, Clarendon, Chester, Chesterfield, Fairfield, Georgetown, Hampton, Jasper, Kershaw, Lancaster, Lee, Marion, Marlboro, Newberry, Orangeburg, and Williamsburg.

The first construction reports are expected by mid-October and all projects are scheduled to be completed by October 2022.

CMS Expands Telehealth Coverage in Proposed 2022 Physician Fee Schedule

By News

By Eric Wicklund

– The Centers for Medicare & Medicaid Services’ proposed 2022 Physician Fee Schedule offers some good news for telehealth advocates.

The 1747-page draft, released this week, proposes to make permanent some provisions enacted years to address the coronavirus pandemic, while continuing most until at least Dec. 23, 2023 “so that there is a glide path to evaluate whether the services should be permanently added to the telehealth list following the COVID-19 PHE (Public Health Emergency).”

CMS is proposing to eliminate geographic restrictions on telemental health coverage and to make the patient’s home an originating site, as long as patient and telemental health provider meet in-person within six months of beginning telehealth services and at least once every six months after.

“We are seeking comment on whether a different interval may be necessary or appropriate for mental health services furnished through audio-only communication technology,” the agency said in a press release. “We are also seeking comment on how to address scenarios where a physician or practitioner of the same specialty/subspecialty in the same group may need to furnish a mental health service due to unavailability of the beneficiary’s regular practitioner.”

As for audio-only telehealth, CMS is proposing to amend its requirements for interactive telecommunications systems, which now focus on real-time, two-way, audio-visual telemedicine technology, to include audio-only telehealth when used for the diagnosis, evaluation or treatment of mental health issues in the patient’s home.

“CMS is proposing to limit the use of an audio-only interactive telecommunications system to mental health services furnished by practitioners who have the capability to furnish two-way, audio/video communications, but where the beneficiary is not capable of using, or does not consent to, the use of two-way, audio/video technology,” the agency said. “CMS is also proposing to require use of a new modifier for services furnished using audio-only communications, which would serve to certify that the practitioner had the capability to provide two-way, audio/video technology, but instead, used audio-only technology due to beneficiary choice or limitations.”

“CMS is also soliciting comment on: (1) whether additional documentation should be required in the patient’s medical record to support the clinical appropriateness of audio-only telehealth; (2) whether or not we should preclude audio-only telehealth for some high-level services, such as level 4 or 5 E/M visit codes or psychotherapy with crisis; and (3) any additional guardrails we should consider putting in place in order to minimize program integrity and patient safety concerns,” CMS added.

In addition, CMS plans on expanding Medicare coverage for telemental health services delivered by federally qualified health centers (FQHCs) and rural health clinics (RHCs). Neither are designated by CMS as a distant site practitioner for telehealth, but the agency is proposing to allow coverage for mental healthcare services furnished by real-time telecommunication technology, including audio-only telehealth.

As far as remote patient monitoring coverage goes, CMS said it is “engaged in an ongoing review of payment for E/M visit code sets.” Changes highlighted in the CMS press release don’t factor into RPM coverage, and RPM experts are still poring over the document to ascertain whether more coverage is on the horizon.

Comments on the proposed rules are due by September 13.

Kaiser Permanente Study Measures the Impact of Telehealth on the Environment

By News

By Eric Wicklund

A five-year analysis of outpatient visits at a Pacific Northwest health system found that a shift to telehealth helped to dramatically reduce the amount of greenhouse gas emissions.

– New research from a trio of healthcare’s heavy hitters indicates telehealth is also good for the environment.

In what’s being billed as the first large-scale study in the US, researchers from Kaiser Permanente, Brigham and Women’s Hospital and Harvard Medical School are reporting that connected health platforms dramatically reduce greenhouse gas emissions, making those services as healthy for the environment as they are for patients.

The study, published online in The Journal of Climate Change and Health, attributes most of the results to the adoption of telehealth during the coronavirus pandemic, when in-person visits dropped sharply and both providers and payers limited their travel time. But the researchers noted that any telehealth service offers an opportunity to reduce stress on the environment.

“The rapid and widespread adoption of telehealth during the COVID-19 pandemic has had significant environmental health benefits, primarily through reduction in transportation-associated emissions,” the study concluded. “If the US healthcare system were to maintain or expand upon current levels of telehealth utilization, additional reductions in GHG emissions would potentially be achieved through impacts on practice design. Ambulatory visit carbon intensity would be an effective way to measure these changes.”

The researchers focused on Kaiser Permanente Northwest serving some 600,000 people in Oregon and southwest Washington. Working with colleagues from BID and Harvard, they tracked transportation-related greenhouse gas (GHG) emissions for outpatient visits – including primary care, specialty care and mental healthcare – from 2015 to 2020. In all, they charted 15.6 million outpatient visits, a 15.9 percent overall and an average increase of 3.2 percent per year.

That all changed with COVID-19, which saw in-person outpatient visits drop 46.2 percent in 2020, while telehealth visits – which had been growing 39.3 percent each year – surged 108,5 percent.

The researchers pointed out that the reduction in GHG emissions isn’t tied to a decline in healthcare visits, since those visits were still happening online. And they said changes in fuel efficiency or transportation mode share would have a minimal effect.

Likewise, the reduction in GHG emissions caused by a shift to telehealth outweighs any increase in emissions associated with the use of telemedicine equipment, either by patients at home or providers at hospitals and medical offices. And the study may even by underestimating GHG emission reductions, as it didn’t account for providers working from home during the pandemic.

As part of the study, the research team developed a new metric that will help future projects measure an outpatient facility’s environmental footprint.

While touted as the largest study of its kind, it isn’t the first to take into account the environmental benefits of telehealth.  Earlier this year, CommonSpirit Health, a Chicago-based network encompassing some 700 care sites and 142 hospitals in 21 states, issued an Earth Day press release estimating that its connected health platform had reduced announce GHG emissions in a year to equal 250,000 trees planted and more than 3,000 cars removed from roadways.

And in 2017, the American Telemedicine Association launched a task force, organized by then-president Peter Yellowlees, to study how telemedicine might be affecting climate change and global warming. The effort was spurred by a study from the University of California at Davis – where Yellowlees is a professor of clinical psychiatry – that found that its telehealth program saved patients and clinicians 5 million miles of travel over 18 years, amounting to about nine years in travel time and $3 million in costs, and helped UC Davis reduce nearly 2,000 metric tons of carbon dioxide, 50 metric tons of carbon monoxide, 3.7 metric tons of nitrogen oxides and 5.5 metric tons of volatile organic compounds.

“Telemedicine and health information technology help save time, energy, raw materials (such as paper and plastic), and fuel, thereby lowering the carbon footprint of the health industry,” Yellowlees wrote in a 2010 paper titled Telemedicine Can Make Healthcare Greener. “By implementing green practices, for instance, by engaging in carbon credit programs, the health industry could benefit financially as well as reduce its negative impact on the health of our planet.”


Congress Eyes Seniors’ Access to mHealth Tools for Diabetes Care Management

By News

By Eric Wicklund

– A pair of Senators has re-introduced proposed legislation aimed at give seniors better access to mHealth and telehealth tools for diabetes care management.

The Improving Medicare Beneficiary Access to Innovative Diabetes Technologies Act, filed earlier this month by Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), takes aim at the growing field of connected health devices and platforms for those living with diabetes. It would improve Medicare coverage for such things as implantable continuous glucose monitors, insulin dosing systems, mHealth apps and platforms and the artificial pancreas.

According to the American Diabetes Association, some 34.2 million Americans are living with diabetes, including 7.3 million who are undiagnosed. Of that number, 14.3 million, or 26.8 percent, are seniors.

Healthcare innovators have made significant strides in recent years in developing mHealth and telehealth tools that allow those living with diabetes to monitor their health and collaborate with their care providers. The technology allows providers and patients to manage care around the clock, adjusting medications to address trends, avoid serious health concerns like hypoglycemia and hyperglycemia and improve long-term clinical outcomes.

“Technological advances make diabetes easier to manage,” Collins said in a press release. “The market arrival of cutting-edge diabetes technologies, however, does not immediately benefit patients if older Americans are unable to afford them. I have heard from numerous seniors who, when transitioning from employer-provided insurance to Medicare, were shocked to learn that the technologies they have relied upon for years to manage their diabetes are no longer covered. … Our bill would help ensure that outdated Medicare coverage criteria does not impede access to technologies that will improve care and reduce costs to the health care system as a whole.”

The bill, which was introduced in 2019 by Collins and Shaheen but failed to make it out of committee, would create a task force within the Health and Human Services Department to propose policies on coverage and payment for innovative diabetes technologies and services for seniors. It would report annually to the HHS Secretary and Centers for Medicare & Medicaid Services Administrator on:

  • Existing Medicare benefit categories under which innovative diabetes technologies and services should be covered;
  • Changes to Medicare statute and changes to regulations and sub-regulatory guidance for existing benefit categories that would be necessary to accommodate coverage and payment of innovative diabetes technologies and services;
  • The elimination of other unnecessary burdens that impede access to innovative diabetes technologies and services;
  • Proposals for a new benefit category for covering certain technologies and services that cannot otherwise be covered through changes to regulations and sub-regulatory guidance for existing benefit categories and specifications for the new benefit category and
  • Proposals to streamline interagency administrative processes through greater FDA and CMS collaboration that would facilitate prompt approval or clearance and coverage of innovative technologies and services for patients with diabetes.

Source mHealth Intelligence