United States: 21st Century Cures: Required Exploration Of Telehealth Solutions

Summary



President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including specifically calling out telehealth—the use of electronic information and communication methods to provide patient care when the healthcare professional and patient are not located at the same facility—as a potential means of delivering safe, effective, quality health care services to Medicare beneficiaries, and directs two federal agencies to investigate and report to Congress on its current and potential uses. This On the Subject summarizes Section 4013 of Title IV of the new legislation. Please see our continuing coverage of this legislation for discussion of additional titles and provisions.

In Depth

On December 7, 2016, the US Congress approved the 21st Century Cures Act (Cures Act), substantial legislation intended to accelerate "discovery, development and delivery" of medical therapies by encouraging biomedical research investment and facilitating innovation review and approval processes, among other things. The massive bill specifically calls out telehealth—the use of electronic information and communication methods to provide patient care when the health care professional and patient are not located at the same facility—as a potential means of delivering safe, effective, quality health care services to Medicare beneficiaries, and directs two federal agencies to investigate and report to Congress on its current and potential uses.

President Obama signed the Cures Act on December 13, 2016, after previously expressing his support for the bill.

Overview of Key Telehealth Provisions in Cures Act

The legislation, if enacted, would require the Centers for Medicare & Medicaid Services (CMS) and Medicare Payment Advisory Commission (MedPAC) to report to the committees of jurisdiction in the House and Senate on the current and potential uses of telehealth in the Medicare program, to assist Congress in its ongoing assessment of Medicare coverage of telehealth services with a focus on the "originating site" requirement. The originating site—the site at which the patient is located at the time of the telehealth encounter—must be a certain type of health care facility that is located in a rural area, which significantly reduces the number of Medicare patients receiving care via telehealth.

Notably, Cures Act provides that it is the "sense of Congress" that eligible originating sites should be expanded and any expansion of telehealth services under the Medicare program should:

  • Recognize that telehealth is the delivery of safe, effective, quality health care services, by a health care provider, using technology as the mode of care delivery;
  • Meet or exceed the conditions of coverage and payment with respect to the Medicare program if the service was furnished in person, including standards of care; and
  • Involve clinically appropriate means to furnish such services.

Congress' "sense" statement communicates its desire for the development of a telehealth coverage expansion plan that contemplates the delivery of clinically appropriate types of services to Medicare beneficiaries in light of the applicable "standards of care", which are generally the same whether the patient is seen in person or through telehealth technologies, and other conditions of coverage requirements.

Relevant Background and Impact of Cures Act on Medicare Telehealth Coverage

Currently, Medicare coverage of telehealth is limited to circumstances where the following four categories of requirements are satisfied:

Originating Site. An originating site is the location of an eligible Medicare beneficiary at the time the telehealth service occurs. Medicare beneficiaries are eligible for telehealth services only if they are presented from an originating site located in:

  • A rural Health Professional Shortage Area (HPSA) located either outside of a Metropolitan Statistical Area (MSA) or in a rural census tract; or
  • A county outside of a MSA.

The types of authorized originating sites are the offices of physicians or practitioners, hospitals, critical access hospitals, rural health clinics, federally qualified health centers, certain types of renal dialysis centers, skilled nursing facilities, and community mental health centers.

It is unclear whether Congress' "sense" that the originating site requirement warrants expansion relates to its facility type or geographic components, or both.

Distant Site Practitioner. Practitioners at the "distant site" who may furnish and receive payment for covered telehealth services are physicians, nurse practitioners, physician assistants, nurse-midwives, clinical nurse specialists, certified registered nurse anesthetists, clinical psychologists and clinical social workers, and registered dietitians or nutrition professionals. The practitioner at the distant site must be licensed to furnish the service under state law. Unlike the originating site, there are no geographic or facility-specific requirements applicable to the distant site.

Telehealth Technologies. Only interactive audio and video telecommunications systems that permit real-time communication between the patient at the originating site and the practitioner at the distant site may be used.

Types of Services. While the list of covered telehealth services is expanding (albeit slowly), only a small defined set of services, including consultations, pharmacological management, office visits, and individual and group diabetes self-management training services, are currently covered by Medicare.

These limitations on Medicare coverage have severely limited the ability of health care practitioners to provide and get paid for the delivery of telehealth services to Medicare beneficiaries. To illustrate, in 2015, Medicare paid a total of $17,601,996 for telehealth services—an infinitesimal portion of the Medicare program's $630+ billion budget.

Congress' primary concern with expanding Medicare coverage of telehealth relates to cost. The Congressional Budget Office (CBO) acknowledges the difficulties associated with determining whether Medicare coverage for telehealth services would increase or decrease federal spending, as the extent to which telehealth services would be a substitute for (or reduce the use of) other Medicare-covered services is unclear.

According to CBO, if all or most telehealth services prevented the use of, or served as a substitute for, more expensive services, coverage of telehealth could reduce federal spending. On the other hand, if telehealth services are used in addition to currently covered services, then increased coverage of telehealth services would increase Medicare spending. Because many of the proposals considered by Congress to date focus on expanding Medicare beneficiaries' access to health care services, CBO tends to generally view telehealth as cost prohibitive.

Cures Act directs CMS and MedPAC to gather and analyze the "hard data" necessary for Congress to better understand telehealth's potential to improve patient care to Medicare beneficiaries and its financial impact, and to identify appropriate adjustments to the Medicare program (with a focus on expanding the "originating site" requirements) in light of these findings.

TELEHEALTH RESEARCH ISSUE ASSIGNMENTS UNDER CURES ACT
CMS MedPAC
  • The populations of beneficiaries whose care may be improved most in terms of quality and efficiency;
  • Activities by the Center for Medicare and Medicaid Innovation that examine the use of telehealth services in models, projects, or initiatives;
  • The types of high-volume services that might be suitable for telehealth; and
  • Barriers that might prevent its expansion.
  • The services currently paid for under the Medicare fee-for-service program;
  • The services currently paid for under private health insurance plans; and
  • Ways in which payment for telehealth services might be incorporated into the Medicare fee-for-service program.

The gathering and analysis of this information will assist Congress and CBO to address certain ongoing financial and quality of care concerns about the use of telehealth outside of the narrowly defined "originating site." Addressing these longstanding concerns may help to open doors for the delivery of telehealth services to Medicare patients who are located in non-rural areas or who have conditions that can be managed, treated and/or observed outside of the four walls of a medical facility, such as at home or work.

Considerations for Health Care Providers and Technology Companies

While it is unlikely that Cures Act will have an immediate and significant impact on Medicare's approach to telehealth coverage, Cures Act (and other pieces of federal legislation focused on expanding telehealth services to Medicare beneficiaries) signals Congress' continued consideration of telehealth's ability to lower the costs of health care delivery and improve patient health. In light of this increased legislative activity and the change in administration, health care providers and telehealth technology companies should:

  • Continue exploring ways to tailor their care delivery and revenue models to provide telehealth services to this large (and growing) segment of the population.
  • Consider developing or participating in studies designed to test the efficacy and efficiency of telemedicine programs.
  • Consider engaging with CMS and MedPAC on the issues in order to provide the federal government agencies charged with this investigation the best available industry information.
  • Focus operational goals to achieve cost and value goals that are of concern to the government.

21st Century Cures: Required Exploration of Telehealth Solutions

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.