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
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions