The Federal Communications Commission released a list of healthcare providers that were approved for funding through its COVID-19 Telehealth Program authorized by the CARES Act. Conway Medical Center, formally known as Conway Hospital, is the first hospital in South Carolina to received funding through this program. Click the link below for more details.
The U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing. Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit. These tests have been authorized under separate, individual EUAs. Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home collection kit.
“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”
Today’s EUA for the Everlywell COVID-19 Test Home Collection Kit permits testing of a sample collected from inside the patient’s nose using the authorized self-collection kit that contains nasal swabs to collect a sample and a tube filled with saline to transport the sample back to a specified lab. Once patients self-swab to collect their nasal sample, they will ship the sample overnight to a specific CLIA-certified lab that is running one of the in vitro diagnostic molecular tests authorized under a separate EUA for use with the Everlywell at-home sample collection kit. The labs authorized to test specimens collected using the Everlywell at-home collection kit are Fulgent Therapeutics and Assurance Scientific Laboratories. Results will be returned to the patient through Everlywell’s independent physician network and their online portal.
This announcement follows two recent EUAs for diagnostic tests that also use at-home specimen collection: one that uses a sample collected from the patient’s nose with a nasal swab and transported in saline and another that permits testing of a saliva sample collected by the patient at home. Everlywell’s EUA request leveraged data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group to demonstrate stability of specimens during shipping. The data from these studies are freely available to support other EUA requests, alleviating each test developer of the burden of recreating the same study.
The Everlywell home-collection kit is currently the only authorized COVID-19 at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests. The kit and associated tests are available by prescription only.
Today’s authorization is limited to the Everlywell COVID-19 test for at-home collection of nasal swab specimens for analysis by COVID-19 diagnostic tests specifically authorized under separate EUAs for use with specimens collected with the Everlywell at-home collection kit. It is important to note that this is not a general authorization for at-home collection of patient samples using other collection kits, swabs, media, or tests, or for tests fully conducted at home.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
– With the coronavirus pandemic putting a strain on mental health services, a group of lawmakers is asking Congress to give telehealth more time to prove itself.
In a May 21 letter to Congressional leadership, 32 House members are asking that ongoing emergency efforts to relax telehealth regulations during the pandemic be continued “for a reasonable transition period following the COVID-19 emergency period to collect appropriate data to provide an adequate amount of time to determine which of those flexibilities should be continued permanently.”
The order would be included in the next COVID-19 relief bill, the lawmakers said.
(For more coronavirus updates, visit our resource page, updated twice daily by Xtelligent Healthcare Media.)
“Telehealth is proving to be an extremely successful approach in ensuring that patients are receiving mental health and addiction care during this trying and unprecedented time, and we applaud the Centers for Medicare and Medicaid Services (CMS) for expanding behavioral telehealth flexibilities, and ultimately increasing access to these essential services,” the letter states. “In particular, we are grateful that CMS is providing broader coverage of behavioral telehealth services, which has helped expand access to many individuals in rural and medically underserved areas, and allowed individuals to receive these services in their home.”
To meet the rising demand for telemental health services, federal and state agencies have enacted a number of emergency declarations since March to expand access to and coverage of connected health platforms. While expanding the number of providers able to use telehealth and including locations such as the home as distant sites for telehealth, they’ve also expanded coverage to audio-only phone and some video chat platforms that had previously been banned.
These relaxed rules are set to expire when the national emergency is declared over, but there’s a groundswell of support to extend some of the declarations so that the healthcare industry can continue to expand telehealth. Advocates also want more time to build a body of evidence to support telehealth adoption.
“The mental health of each American is vital to the overall health of our nation. Without proper access to care, we are doing a disservice to those most in need,” US Rep. Tom Emmer (R-MN), who drafted the letter with US Rep Paul Tonko (D-NY), said in a press release. “The mental telehealth care offered during the COVID-19 pandemic is an important step towards providing more access and quality care for individuals in need, and it’s important that these services continued to be offered following this high-stress time. Telehealth is the future of health care, and we must begin to integrate it when appropriate in order to serve everyone where they are.”
In particular, the lawmakers are asking that CMS continue to cover audio-only phone services to help people living in areas with poor internet connectivity or without access to smartphones or video-based online platforms.
“Without regular access to behavioral health services, we are concerned that thousands of individuals will be seeking emergency care, with many turning to substance misuse or suicide risks,” the letter concludes. “Telehealth is proving to be a successful means in bridging this gap of care, and it is critical that once the COVID-19 pandemic subsides, access to behavioral health services does not.”
Among those supporting the letter are Mental Health America, the National Association for Behavioral Health, the National Council for Behavioral Health, the American Psychological Association, the American Society of Addiction Medicine and the American Foundation for Suicide Prevention.
Enabling access to care during the pandemic is our main priority at BlueCross BlueShield of South Carolina. According to recent data from the Blue Cross Blue Shield Association, 75% of Americans with behavioral health conditions are continuing therapy services during the COVID-19 pandemic because of the prevalence of telehealth and other digital health services.
“We have seen our members embrace telehealth options when seeking care for mental health conditions and, by adding more than 800 behavioral health providers to our telehealth network, we have significantly expanded our telehealth access to behavioral health services.” — Dr. Matthew Bartels, MD, CPE, FAAP, vice president and chief medical officer at BlueCross BlueShield of South Carolina
– The Federal Communications Commission has approved funding from the COVID-19 Telehealth Program for an additional 43 healthcare providers, though some lawmakers are questioning when any of those providers will get the money.
The latest group of award recipients – the seventh such group – brings the total to 132 providers in 33 states and Washington DC. To date, the FCC has earmarked a little more than $50 million from the $200 billion fund in roughly one month.
During the COVID-19 crisis, there has been unprecedented interest in the use of telehealth as its unique qualities make it an invaluable tool when faced with a highly infectious disease. Pre-COVID-19 telehealth policy barriers have been removed at a rapid rate, however, these changes are temporary. Once the initial reaction to the temporary waivers had passed, the next question on many people’s minds is, “What policy changes will stay after COVID-19?”
What follows is not based upon any “inside” information or discussions with policymakers. It is only CCHP’s assessment of what temporary policy changes are likely to remain and what issues policymakers may wish to pursue further action.
Many of the waivers during the public health emergency (PHE) addressed reimbursement policy. Pre-COVID-19, the majority of established telehealth related policies centered on reimbursement. Reimbursement policy is usually structured around four specific questions:
- Where was the patient located when the telehealth interaction took place?
- Who was providing the services?
- What services are covered?
- What modality was used to deliver the service?
There is a good possibility changes related to all of these issues will remain after the PHE or at least be of further discussion for policymaking. Specifically, the home will likely continue to be an eligible location where a patient may receive services. There will still be a good portion of the population that will continue to minimize their activities outside of the home, some out of necessity as they may be particularly vulnerable to COVID-19. They will still need to receive services so allowing the home to be a continued eligible originating site will likely remain.
Pre-COVID-19 the home was allowed as an eligible originating site in Medicare and some Medicaid programs, but only for very specific services. If the home is to continue to be an eligible originating site, the types of services provided in the home will need to be expanded from what was allowed pre-COVID-19. Therefore, the expansion of the types of services covered when delivered via telehealth will likely remain in some form. Where Medicare is concerned, this is also one area where they would not need a statutory change to allow for more services to be reimbursed if delivered via telehealth. The Centers for Medicare and Medicaid Services (CMS) is only required by law to have a process in place to decide what services should be reimbursed if delivered via telehealth. Therefore, CMS could easily let the expanded COVID-19 list of codes stand.
Additionally, CMS has some flexibility on what is an eligible originating site, geographically. Federal law requires it to be in a “rural” area, but there is no definition given in statute to “rural” as it applies to telehealth. CMS does have it within their powers to have a definition that would geographically encompass more locations than what was eligible pre-COVID-19 by defining “rural” more broadly. There is also precedent for CMS taking such action as it was redefined in 2014.
It is also possible that the expanded list of what is an eligible provider may remain. During this time, it became quite apparent that many eligible, but necessary providers were left off the list of what practitioners were eligible to provide services via telehealth and be reimbursed. Federally Qualified Health Centers (FQHCs), Rural Health Clinics (RHCs) and allied health professionals such as physical and occupational therapists were notably missing pre-COVID-19. In both Medicare and many Medicaid programs, allowing these providers to be eligible providers is a temporary change that will only last during the PHE. However, there has been recognition that these practitioners are needed to provide services if patients continue to limit their activities outside of the home. This will likely be a change that remains, especially if the types of services that can be provided via telehealth also expands.
During COVID-19, recognizing not everyone has access to the technology in their home, policymakers made allowances for audio-only phone to be a means in which to provide services. It is less clear if this change will remain, but what it has brought to many policymakers’ attention is that there is a digital divide that exists in the population. As we navigate the post-COVID-19 world and if telehealth becomes more ubiquitous, this disparity will need to be addressed less we leave segments of the population behind, unserved and vulnerable.
OTHER POLICY ISSUES
COVID-19 raised other telehealth policy issues unrelated to reimbursement, but significantly impacting telehealth. While the temporary measures related to these issues are less likely to remain intact with what was done to address COVID-19, the issues have been elevated and we may find policymakers more interested and invested in exploring and creating policy to address them than they were pre-COVID-19. These issues are:
- Broadband – Not having adequate connectivity contributes to the aforementioned digital divide issue. While broadband and licensure (discussed below) have always been significant issues raised when discussing telehealth even in pre-COVID-19 times, the discussion may be pushed to a much higher priority now.
- Licensure – One significant development during COVID-19 that may have made policymakers more interested in discussing licensure issues is the personal impact they may have felt. For example, college campuses closed down and students were sent home. However, some of those students were receiving services from their student health program on campus. Yet, if the student went home to another state, they were unable to access the continued services of that student health provider even if that provider was able to utilize telehealth, because it was unlikely that provider would be licensed in the student’s home state. There is the possibility that some lawmakers have experienced this first hand or knew of someone who did. These types of examples of personal experience may make policymakers more open to significant discussions regarding licensure.
- HIPAA/Privacy – It is unlikely the temporary discretion exercised on fining for HIPAA violations will remain, but this temporary waiver may spur discussions on whether telehealth-specific policies in HIPAA are needed. Currently, there is nothing in HIPAA that specifically relates to telehealth. Policymakers may decide that this needs to change in a post-COVID-19 world.
- Prescribing – During the PHE, one of the exceptions to allowing telehealth to be used to prescribe a controlled substance without the prescribing practitioner having conducted an in-person exam of the patient was activated. It will go away once the PHE is declared over, leaving the same narrow exceptions telehealth faced pre-COVID-19. One of those exceptions was creation of a registry which was to have happened at the end of 2019, but the Drug Enforcement Agency (DEA) have yet to issue their proposed regulations. There could be increased pressure on the DEA to at least create the registry if not a re-examination of how and when to use telehealth in prescribing controlled substances.
One thing we are certain of, the telehealth landscape is unlikely to revert back to the way it was. Too many consumers have been exposed and utilized telehealth and it will be difficult to take it away once people have experienced it. COVID-19 has significantly impacted all aspects of our lives and will continue to do so for the foreseeable future. Telehealth will play a part in what that future will look like.
Mei Kwong is the Executive Director for the Center for Connected Health Policy (www.cchpca.org) which is the federally designated National Telehealth Policy Resource Center.
Deep divides in internet infrastructure across South Carolina persist, but with new data and a refreshed call to action brought by the COVID-19 pandemic, improvements seem more likely than ever.
Research commissioned by state health organizations show for the first time where residents can’t buy a reliable internet plan. The analysis found 193,000 households, or nearly one in 10 in South Carolina, don’t have a good connection.
BAMBERG, SC—Palmetto Care Connections (PCC) Chief Executive Officer Kathy Schwarting announces that Scott Moody has joined PCC as director of finance.
In his role, Moody oversees the financial operations of PCC including implementing financial policies, overseeing financial records, and completing assessments, reports, annual budgets and financial projections.
“In the past, PCC has contracted with an independent entity for financial services and audits, but as our organization continues to grow, it became more advantageous for PCC to establish more financial operations in-house,” said Schwarting. “Scott’s experiences and expertise in health care finance and management are tremendous assets to Palmetto Care Connections and we’re excited to have him on our team.”
Moody has more than twenty-five years of management, consulting and leadership experience in the areas of hospitals, non-profits, ambulatory surgery centers, large group physician practices and outpatient diagnostic centers. Prior to joining PCC, Moody was owner of Integritas, LLC, 2018 to present; director of practice operations for Surgical Specialists of Charlotte 2014-2017; practice management consultant for Mecklenburg Foot & Ankle Associates of Charlotte, 2013-2014; chief executive officer of Urology Center of Spartanburg and Lowcountry Urology Clinics, 2006-2014; practice management consultant Carolina Eyecare Physicians of Charleston 2005-2006; administrator, Trident Health System Ambulatory Surgery Centers in Walterboro and Charleston, 2000-2005; and executive director Lowcountry Area Health Education Center – MUSC, 19932000.
Moody received his Master in Health Administration degree from the Medical University of SC in Charleston and a Bachelor of Arts degree in political science from the College of Charleston.
Originally from Walterboro, S.C., Moody has lived the Spartanburg area for a total of more than ten years. He and his wife, the late Lynn Moody, have two grown children, son Marshall Scott Moody Jr. who is a student at the University of South Carolina – Upstate, and daughter Janice Elizabeth Moody who is a student at Converse College.
Moody is a member of El Bethel United Methodist Church in Spartanburg where he has served on the administrative board and has worked with the UMC Youth Group.
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 leads the S.C. health care broadband consortium which facilitates broadband connections for health care providers throughout the state. PCC co-chairs the South Carolina Telehealth Alliance, along with the Medical University of South Carolina, partnering with health care organizations and providers to improve health care access and delivery for all South Carolinians.
Four senators are asking Congress to include $2 billion in the next COVID-19 relief package to help rural communities and healthcare providers improve broadband connectivity to fuel telehealth expansion.
While telehealth interests have been broadly served by Coronavirus relief bills to date, a group of lawmakers is looking for more support in the next package.
Led by Senator Brian Schatz (D-HI), a longtime supporter of connected health adoption, a group of senators is lobbying to add $2 billion to the next relief bill for broadband expansion, a key and often overlooked component to nationwide telehealth adoption. They’re calling on Congress to add that money to the Rural Health Care (RHC) Program.
“Congress must do more for our health care providers so that they can meet telehealth needs during the COVID-19 pandemic,” the senators wrote in a letter to Congressional leadership. “This additional support would expand the reach of the RHC Program to enable health care providers at non-rural and mobile health care facilities to engage in telehealth, eliminate administrative red tape that slows down the ability of front-line providers to obtain broadband connectivity, and provide more resources to current health care providers in the RHC Program so they can increase their broadband capacity to effectively treat their patients.”
Comprised of the Telecommunications Program, which makes up for the difference between urban and rural connectivity costs, and the Health Care Connect Fund, which covers as much as 65 percent of those connectivity costs, the RHC Program was established in 1997 and given a $400 million cap. In 2018, with demand for funding outpacing resources, the FCC added money to the fund.
But demand for rural broadband access is still growing, caused in part by an expansion of telehealth programs. To help healthcare providers and others looking to build out their telemedicine and mHealth platforms, the FCC has launched a three-year, $100 million Connected Care Pilot Program and, more recently, the $200 million COVID-19 Telehealth Program, the latter funded by the Cares Act.
Schatz and his colleagues – Senators Lisa Murkowski (R-AK), Angus King Jr. (I-ME) and john Boozman (R-AR) – say the ongoing COVID-19 emergency will add to the pressure on the RHC Program, as more and more providers turn to telehealth to improve access to care and payers ease restrictions during the pandemic to make that happen.
“The coronavirus pandemic has dramatically increased the need to expand telehealth so that health care providers can treat patients safely, without putting themselves or their patients at risk,” the senators said. “As a result, many health care providers are facing connectivity challenges in meeting this new demand for telehealth. It is imperative that Congress act to ensure our front-line responders have the tools they need to combat this deadly virus.”
In the weeks that have seemingly passed very slowly, we have learned these five things relatively quickly from being in public health emergency.
1. Bureaucracy impedes emergency response. Our governmental infrastructure is simply clunky in overly complicated ways. The best intentions behind legislative acts and executive orders have been gummed up by administrative and bureaucratic processes at both federal and state levels. The very system designed to appropriately bestow power has proven impotent amidst the public health emergency.
2. Policy has been out of sync. In a day when people carry around more technology in the palm of their hands than was used to land on the moon, it took COVID-19 to demonstrate that healthcare policy, which drives both reimbursement and access to care, has been running in last place.
3. People are always our best resources. When state and federal stockpiles of PPE came up short, every little old lady (myself included) came to the rescue by pulling out sewing machines and scrap fabric in an effort reminiscent of WWII bandage-making. Likewise, local restaurateurs have kept our COVID units fed even when their own businesses have been shuttered. Acts of charity and kindness, both big and small, have supported healthcare professionals on the front line. It has been a win for humanity.
4. Culture undergirds strategy. Organizations that are team-oriented and encourage collaboration have been more nimble than rigid top-down driven healthcare systems. Any effective emergency response relies not only on skill and training but also on innovation and mission. A healthy culture will stay grounded even when forced to color outside the lines.
5. Our reality has changed. Uncertainty and inconvenience have altered our sense of reality. The perception that we, as a society and as an industry, were unalienable has crumbled. Focusing on the greater common good and acknowledging past vulnerabilities will certainly shape more robust leadership as we move forward.
Of the lessons learned, the ones which have impacted us to our core will be what fuels survival and restored viability. Some of the challenges will remain out of our direct control. For those we will be forced to remain reactive. However, the things that are in our control—how we adjust, lead and serve—can be a positive impetus for any healthcare organization rising from the ashes.