Is Wearable Health Tech Poised to Play a Bigger Role in Washington?

High costs. Disparities. Limited accessibility.  Everyone agrees that there are a lot of things wrong with the US health care system right now.  Fortunately, lawmakers, administration officials, and stakeholders are beginning to coalesce around wearable health technology as a possible solution because of its potential to tackle many health care problems.  For example, wearable tech can address:

  • High health care costs by allowing clinicians to monitor patients and intervene before a health condition becomes worse, thereby saving the health care system money.
  • Health disparities by helping practitioners monitor and treat conditions like hypertension, which are more prevalent in communities of color. 
  • Limited access to health care providers in rural areas by allowing practitioners to remotely track patients without worrying about geographic constraints.

Given the obvious benefits of wearable tech, what are policymakers and providers doing to promote it?

Congressional Action

The House Republican Healthy Future Task Force Modernization Subcommittee issued its recommendations for modernizing the health care system on June 1.  A key policy area focuses on development of patient-centered technologies – i.e., wearable tech – while protecting privacy and allowing interoperability. 

There have been legislative proposals on wearable tech, too.  Last year, Rep. David Schweikert (R-AZ) introduced the Advanced Safe Testing at Residence Telehealth (A-START) Act to advance the use of wearable technology.  It would work by establishing Medicare Advantage, Medicaid, and Veteran Affairs demonstration programs to test the efficacy and potential use of modern telehealth tools like wearable tech by allowing patients access to these tools approved by the Food and Drug Administration (FDA). 

Administration Action

While the Biden administration does not seem to have a specific initiative to promote the use of wearable health technology, review of wearable tech has been a regular practice of the federal government for several years.  In 2016, for instance, the FDA issued guidance on regulating “general wellness products” that help monitor health, nutrition, and fitness.  Additionally, the FDA issued numerous emergency use authorizations (EUAs) for wearable devices during 2020 to help patients access providers during the COVID-19 public health emergency (PHE).

However, the promise of wearable tech is not lost on the Biden administration.  During an April 28 congressional hearing, Health and Human Services (HHS) Secretary Xavier Becerra agreed with Rep. Schweikert that wearable tech can help reduce health care costs.  If the momentum on crafting policy around wearable tech on Congress continues, lawmakers probably wouldn’t have a tough time finding allies in the White House.

Stakeholder Action

Health care providers are getting on board with wearable tech, too.  In May, a group of health care providers, drug manufacturers, and universities launched the Digital Health for Equitable Health (DHEH) Alliance.  Initial members of the group include the American Cancer Society, Otsuka Pharmaceuticals, and the Howard University College of Medicine.  The new organization’s goal is to promote digital health policies like wearable tech to eliminate health disparities and barriers to high quality care.  However, the DHEH Alliance has yet to announce a specific policy agenda.

What Happens Next?

Wearable health technology may be starting to gain ground, but current proposals pertaining to wearable tech are still in their infancy.  First, there’s not a lot of legislation introduced around this topic, aside from Rep. Schweikert’s bill and the GOP task force’s recommendations.  Second, wearable tech doesn’t seem to be a prominent part of the administration’s agenda, even though a top administration official agrees on the promise of the use of these health tools.  Third, industry stakeholders who want to promote wearable health tech have yet to assemble a policy agenda on how they plan to reach their goals.

It’s also worth noting that none of the currently proposed policies address the important issue of how wearable health technology will be reimbursed.  This is related to the broader argument of how the government will pay for health technology services like telemedicine after the COVID-19 PHE ends.

Thus, proponents of wearable tech shouldn’t expect movement on current proposals in the near-term, as Congress will probably be occupied with appropriations and other must-pass items through the end of 2022.  However, things could change next year.   

Republicans are widely expected to take control of at least one branch of Congress in this fall’s midterm election, and in anticipation of their victory, GOP lawmakers have been busy crafting an agenda that steers clear of large, sweeping packages that will be difficult to pass, like another attempt at repealing and replacing the Affordable Care Act (ACA).

Instead, Republicans in Congress are likely to use their majority to advance smaller, less-controversial health care policies that stand a better chance at becoming law, like the House Republican Healthy Future Task Force Modernization Subcommittee’s recommendations on health care technology.  With Republicans likely in control of the House and/or the Senate in the next Congress, momentum on wearables tech could be poised to surge.

The Uncertain Future for Telehealth

April 16, 2022.  That’s the date the current public health emergency (PHE) is set to expire.  The Department of Health and Human Services (HHS) initially promised to provide 60 days’ notice to states and health care organizations before ending the PHE.  However, the Biden administration has been mum on its plans regarding the PHE and has given no indication on whether they will extend the PHE again, leaving stakeholders in doubt as to what will happen to the many temporary health policies that are tied to the PHE.

Background: HHS declared a PHE for the COVID-19 pandemic on January 31, 2020.  Since then, the PHE has been renewed by HHS eight times in 90-day increments with the most recent renewal being on January 14,

The conversation over whether to renew the PHE couldn’t be timelier, as a growing number of federal and state officials have been discussing plans to loosen COVID-19 restrictions as the US shifts to treating COVID-19 as an endemic than a pandemic.  For example, Dr. Anthony Fauci, Chief Medical Advisor to the President, recently commented that the US is exiting the “full-blow” pandemic phase of the COVID-19 crisis, and a number of blue states and cities have begun to announce plans to roll-back certain pandemic requirements like indoor masking.  Additionally, over 70 Republican members of Congressman sent a letter to HHS Secretary Xavier Becerra last week requesting for a concrete timeline on when the PHE will come to an end. 

However, ending the PHE is no simple matter.  That’s because numerous temporary policies related to telehealth, COVID-19 treatments and vaccines, and Medicaid are specifically tied to the PHE.  In this blog post, we’ll focus on telehealth, while COVID-19 treatments and Medicaid will be covered in future installments. 

The CARES Act notably expanded Medicare coverage of telehealth services to make it easier for beneficiaries to access health care services while minimizing the exposure to COVID-19.  These temporary changes include:

  • Waiving Medicare’s geographic site originating requirement to allow beneficiaries to access telehealth in all settings.
  • Allowing audiologists, physical therapists, occupational therapists, speech-language pathologists, and other providers to provide telehealth services under Medicare.
  • Coverage of telehealth services conducted through audio-only technology like telephones and audio-visual technology like smartphone in more instances.
  • Reimbursement of 238 telehealth services, compared to 202 prior to the PHE.
  • Coverage of telehealth services without a pre-existing doctor-patient relationship.

However, all these temporary changes and waivers will expire once the PHE ends.  While members of Congress have put forth multiple legislative proposals to extend Medicare’s temporary telehealth provisions beyond the PHE, few have gained traction.  Adding to the uncertainty is the administration’s lack of communication on whether to renew the PHE another 90 days leaving both providers and beneficiaries in limbo over the status of temporary telehealth flexibilities.   

That’s why stakeholders are pushing for the PHE to stick around after April.  On February 10, the Federal of American Hospitals sent a letter to HHS requesting that the PHE be extended “well beyond” its current expiration date in two months’ time.  FAH argued that an abrupt end to PHE-authorized operations like telehealth run the risk of “destabilizing fragile health care networks” as these temporary measures have been in place for about two years allowing for patients to rely on their care.

And over the course of the past two years, telehealth usage has surged to the point that it now plays a vital role in the way people access health care.  According to HHS, telehealth utilization saw a 63-fold increase in 2020.  The adoption of telehealth in behavioral health was particularly noticeable, which saw about a third of its visits done remotely in 2020.  While telehealth usage has declined somewhat since 2020 and outpatient visits have returned to pre-pandemic levels, overall telehealth utilization remains elevated compared to 2019 levels, and patients and providers don’t  want to give up this health care tool that benefited so many patients.    

Should Payment Parity for Telehealth Continue?

In response to the COVID-19 pandemic, the Centers for Medicare and Medicaid Services issued rulemaking to require Medicare to pay the same rates for telehealth and in-person care for the duration of the public health emergency (PHE).  Now that the end of the pandemic may be in sight, stakeholders are debating whether Medicare should continue offering payment parity for telehealth services post-pandemic.  Since Medicare’s actions often inform what private payers do, stakeholders will be watching closely what the agency decides to do. 

Against Payment Parity

A chief argument against payment parity is that it could lead to overutilization and higher spending.  For patients with the right technology, accessing telehealth can be very convenient, leading health experts to suggest some patients may use telehealth more than necessary.  Corollary to this, some experts are worried about telehealth’s potential to create more opportunities for waste, fraud, and abuse.

Additionally, opponents to payment parity contend that telehealth requires fewer resources and less clinical effort than in-person visits.  For example, a 2017 study from Health Affairs found the average cost of a telehealth visit for an acute respiratory infection was $79 compared to $146 for in-person visits.  Simple virtual check-ins may also require less decision-making, time, and other factors considered “clinical effort” when compared to in-person appointments. 

Furthermore, some worry payment parity in telehealth may propagate low-value care.  For certain conditions, telehealth may prove limiting for providers, and there is no substitute for the type of evaluation physicians can provide through in-person visits.  Parity opponents argue that higher reimbursement rates tied to in-person visits will ensure patients can more regularly receive a full evaluation, thus preventing the likelihood symptoms missed during telehealth visits progress to become more expensive chronic conditions down the road.

For Payment Parity

Those in favor of continuing payment parity post PHE say there is no evidence that telehealth has resulted in overutilization.  Most instances of telehealth usage, parity proponents say, has been to substitute in-person to visits as a result of the COVID-19 pandemic.  According to data from electronic health record company Epic, the number of telehealth visits declined rapidly by summer 2020 following an initial increase in April 2020.  This data suggests that patients are so far not opting for more telehealth visits over in-person visits out of ease or convenience.  Additionally, some physicians argue some diagnoses can require as much clinical effort as in-person visits.  According to a 2020 study from the University of Michigan, surgeons reported spending more time on telehealth than in-person visits.   

Proponents of payment parity also say telehealth services utilize far more resources than patients realize.  While telehealth may not seem to require the same “brick and mortar costs” as in-person visits, providers assert that telehealth requires an investment in technology, both to set-up virtual visits and keep up with changes in technology.  For certain medical conditions, digital monitoring and home-based care products may require additional resources.  Providers also say that some diagnoses can involve just as must clinical effort as do in-person appointments.

Moreover, parity supporters contend that clinical guidelines about when telehealth and in-person care is appropriate can prevent low-value care.  For instance, the American College of Obstetricians and Gynecologists has issued guidance on when patients should require a physical examination. 

What Happens Next?

CMS can continue to pay the same rates or the agency could propose a differential payment rate.  Either way, the decision would be subject to the rulemaking with notice and comment.  For the part of Congress, the legislative branch hasn’t weighed in.  While legislators have introduced a slew of bills to permanently expand telehealth coverage and abolish pre-pandemic restrictions on telehealth, none address how telehealth should be paid for.  A lone exception is H.R. 8308, the Telehealth Coverage and Payment Parity Act.  Introduced by Rep. Dean Phillips (D-MN) in September 2020, the legislation would require commercial insurers to pay the same level for the same level for telehealth services as it would for in-person services.  However, this legislation does not affect Medicare, and as of this writing, the bill has yet to be reintroduced in the 118th Congress.

In their January 2021 public meeting, the members of the Medicare Payment Advisory Commission (MedPAC) suggested that Medicare continue telehealth payment parity for 1-2 years following the end of the PHE as a “pilot program” to evaluate how to telehealth services should be reimbursed permanently.  However, MedPAC’s comments have yet to be taken up in any legislative proposal.

The Government’s Ambitions Plans to Grow Broadband Access

A major barrier to widespread telehealth adoption in the United States is lack of access to broadband internet.  While telehealth utilization has surged since the start of the COVID-19 pandemic, telehealth’s potential for growth is limited by lack of high-speed internet connections for both patients and providers.

However, not all Americans have access to broadband.  A 2019 Federal Communications Commission (FCC) report found 21.3 million Americans, or 6.5% of the population, currently lack access to broadband.  Furthermore, a 2021 survey by BroadbandNow found 42 million Americans are unable to afford broadband without any assistance.  According to the Office of the National Coordinator for Health Information Technology, broadband service provides a higher-level speed of data transmission, which is particular important for live videoconferencing with health care practitioners.  Additionally, broadband allows health care providers to meaningfully use patient information, such as electronic health records, to improve patient outcomes. 

Fortunately, the federal government has taken some steps to boost broadband access. To help patients afford broadband access, the Consolidated Omnibus Appropriations Act, 2021 (P.L. 116-260) provided $3.5 billion to the FCC to establish a program to help low-income Americans get or stay connected to broadband.  The program is required to provide a $50 subsidy for qualified households who must include at least one individual who is eligible for the Lifeline Program, the Supplemental Nutrition Assistance Program, or a Pell Grant.

Providing direct government subsidies to individuals to access broadband looks likely to be part of an upcoming legislative effort to address the nation’s infrastructure needs.  The American Jobs Plan, the Biden Administration’s highly anticipated $2 trillion infrastructure proposal, high-speed broadband to every American, including the 35% of rural Americans who lack high-speed broadband.  Among the ways the Administration plans to achieve this include:

  • Providing individual subsidies to cover internet costs in the short-term and reducing costs through widespread adoption in the long-term.
  • Prioritizing support for broadband networks owned or operated by local governments, non-profits, and cooperatives.
  • Promoting transparency and competition among internet providers and requiring providers to publicly disclose prices their charge.

Direct subsidies are also included in the Leading Infrastructure for Tomorrow’s (LIFT) American Act.  Co-sponsored by all 32 Democrats on the House Energy and Commerce Committee, this proposal will provide a basis for House Democrats’ action on energy and broadband in the Congressional infrastructure bill.  The bill would grow high-speed internet access by:

  • Authorizing an additional $6 billion for the FCC program that provides a discount of up to $50 off the cost of monthly broadband service for eligible households. 
  • Providing $80 billion to develop secure broadband nationwide by funding connections to underserved rural, suburban, and urban communities.
  • Allocating $5 billion in federal funding for low-interest financing of broadband deployment.

While health care providers are already advocating for making permanent some of the Medicare and Medicaid flexibilities for telehealth enacted into law as the result of the coronavirus pandemic, they should be keen to keep an eye out for additional discussion and debate on broadband access.  Both the government’s recent actions to expand broadband and Democratic proposals to boost broadband even further suggest a strong desire to build out an infrastructure that will allow telehealth to flourish in a post-pandemic world.

Amazon Moves to Disrupt Health, Influence Policy

Amazon is primed to disrupt primary care just like the tech giant has done to retail, cloud computing, and package delivery services.  This time, it’s telehealth. 

On March 17, 2021, Amazon took a major step forward in expanding its health care reach by announcing  plans to make Amazon Care, its virtual health service benefit, available to all of its US employees this summer.  Furthermore, Amazon announced its telehealth service will be available to other companies.  Over the next few months, the company also intends to expand its Amazon Care in-person health centers to Washington, DC, Baltimore, and several other cities. 

In September 2019, the company launched Amazon Care for employees and their families in the Seattle metropolitan area.  Amazon Care offers telehealth as well as in-person primary care visits at patients’ homes or in-office.  Additionally, the service incorporates Amazon Pharmacy, the company’s prescription drug delivery service that launched in November 2018

Amazon Care is not the company’s first foray into health care.  In addition to Amazon Pharmacy, the tech giant teamed up with primary care group Crossover Health in 2020 to launch health care centers near its operations facilities and fulfillment centers in Phoenix, Louisville, and Dallas-Fort Worth, with more facilities planned in 2021.  Notably, the company joined forces with JPMorgan Chase and Berkshire Hathaway in January 2018 to launch a new non-profit venture called Haven.  The new venture was intended to utilize the vast resources of its founding companies to address the complexity of health care coverage and rising health care costs. However, Haven was eventually scuttled in January 2021, with lack of a strategy, leadership turnover, and the enormous scale of problems facing the US health care industry cited as likely culprits. 

As illustrated by Haven, Amazon Care’s success is far from guaranteed.  The service faces stiff competition from other well-funded telehealth services, including Doctor on Demand and PlushCare.  Additionally, there has yet to be any data posted on whether Amazon Care has been successful in reducing costs, which was one of Haven’s initial goals.  However, Amazon Care stands out from its competitors by offering integrated pharmacy services and a potential built-in customer base from the over 150 million Amazon Prime subscribers. 

Through its recent ventures into the health care industry, Amazon may be signaling a desire to use its growing health care clout to influence health care policy.  In March 2021, Amazon Care joined with Intermountain Healthcare, Ascension, and several other providers to launch Moving Health Home, a new coalition aimed at changing the way “policymakers think about the home as a site of clinical service.”

Amazon’s desire to impact home health care policy is reflective its overall efforts to enhance its advocacy capabilities in recent years.  In 2020, the company logged $18.7 million in lobbying expenditures, including on health care matters, a nearly two-fold increase from its $9.4 million total expenditures in 2015.  Amazon also boasts 17 registered lobbyists in addition to the 24 lobbying firms on its retainer.  Former Obama Administration White Press Secretary Jay Carney has served as the company’s Senior Vice President of Global Corporate Affairs since 2015, and the company notably chose the Washington, DC metropolitan area for the site of its highly anticipated second headquarters.

By growing its influence in Washington and demonstrating a wiliness to shape home health and other policy areas, Amazon may be using its newfound efforts in telehealth and primary care as another means to sway health policy and achieve its goal of disrupting health care in America.  

Looking to the Future of Telehealth

Telehealth is here to stay, said participants of a March 12 Axios forum on how technology is impacting the health care system.  However, that doesn’t mean telehealth is without its problems, and the participants separately warned of concerns related to privacy, health disparities, and connectivity going forward.

1)  Patient Data.  Sen. Bill Cassidy (R-LA) explained how increased use of telehealth has the potential to allow for misuse of patient data.  He warned an insurer could hypothetically pull data from a smartwatch belonging to a person in the early stages of Parkinson’s disease and increase premiums based on what the data reveals about the person’s movement.  Alternatively, the Senator theorized a health care provider could use the same smartwatch data to stage an early medical intervention.  Thus, Cassidy emphasized a need to ensure health data is being used to help patients and not for nefarious reasons.

2)  Health Disparities.  Additionally, Deneen Vojta, MD (UnitedHealth Group) pointed out how telehealth has laid bare the extent of health disparities in America.  Moving forward, she predicted providers will “focus relentlessly” on addressing disparities by analyzing health data and encouraging more training on data science.  On a side note, Vojta also suggested policymakers standardize quality reporting for telehealth encounters. 

3)  Fragmentation.  While telehealth has made strides over the past year, Ryan Panchadsaram (US Digital Response) said there is still room for improvement.  Much of the telehealth ecosystem remains fragmented, and Panchadsaram stressed a need to ensure more systems can work with each other by promoting interoperability and transparency.  To break the logjam on flow of health data, Panchadsaram recommended implementing a unique patient identifier, which could be made voluntarily to preemptively address privacy concerns.