United States: Giving Telemedicine More Room To Breathe: Recent And Pending State And Federal Actions In The World Of Online Prescribing

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the "Haight Act") came into law as the federal government's first attempt to address the public health risks associated with online pharmacies – such risks including the dispensing of drugs (including addictive drugs to be used recreationally) without a valid prescription, and the dispensing of adulterated drugs, counterfeit drugs, and/or expired drugs, all of which could result in significant harm to individuals who may have been looking for an easy way to obtain prescribed medications at a lower price.

The Haight Act's weapons of choice against risks of questionable online pharmacy practices include (i) a requirement that online pharmacies can only dispense medications after receipt of a written prescription from the ordering patient's treating physician; and (ii) a requirement that prescriptions can only be written by a physician after an in-person patient examination.

Although the Haight Act, as the first federal online pharmacy law, was generally considered a good first step to reign in dangerous practices associated with online pharmacies, changes in healthcare policy and priorities, and the advancement of healthcare technology since 2008, have resulted in a growing realization that the online prescribing hurdles constructed by the Haight Act in 2008 require much-needed adjustment.

The Haight Act: An Origin Story

The dangers of Internet pharmacies were making headlines well before the Haight Act was introduced in the Senate on March 23, 2007. As noted above, the dangerous practices of Internet pharmacies that have grabbed, and continue to grab, the public's attention include the easy online availability of prescription drugs, including opioids, with no prescriptions required. To address the prescription issue without making it harder for consumers to access drugs, some online pharmacies made customers complete online health questionnaires to be reviewed by a physician or other medical practitioner as part of the drug ordering process. The questionnaires were intended to be a quick, efficient, and customer-friendly substitute for an in-person medical examination by a treating physician who, at the end of the exam, still might not prescribe medication.

In practice, the questionnaires were no substitute for an actual medical exam and prescription. Completed questionnaires were usually approved without any communication between prescriber and customer and there certainly was no interaction that remotely resembled the provision of healthcare. Thus, online pharmacies became known for what they often were: an easy way to get prescription medications, including medications that were frequently used on a recreational basis, without the hassles of getting a legitimate prescription from a healthcare professional.

In response to abuses like the above, the Haight Act was written to sharply limit the ability of healthcare practitioners to prescribe controlled substances to patients without a prior in-person medical examination. For example, the Haight Act amended Section 309 of the Controlled Substances Act (21 U.S.C. §829) to include the following excerpted language:

(e) CONTROLLED SUBSTANCES DISPENSED BY MEANS OF THE INTERNET. —

  1. No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.
  2. As used in this subsection:

    1. The term 'valid prescription' means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—

      1. a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or
      2. a covering practitioner.
    1. (i) The term 'in-person medical evaluation' means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals....

Notwithstanding the above language that seems to make "in-person medical evaluations" an unavoidable necessity, the Haight Act also includes seven exceptions that allow telemedicine providers to prescribe medications without having to meet with the patient in-person. Unfortunately, given the narrow application of these exceptions, the exceptions have not alleviated the burdens of the Haight Act on the further development and expansion of telemedicine. For example, two of the exceptions only apply to emergency medical care, and two other exceptions require that the patient being seen by a telemedicine provider be in the physical presence of a provider or practitioner registered with the Drug Enforcement Administration ("DEA"). A fifth exception applies to circumstances established by regulation. As of the date of this writing, there are no circumstances established by regulation.

In summary, the narrowness of the exceptions for telemedicine has generally left telemedicine providers without the ability to prescribe controlled substances for their patients. Therefore, telemedicine supporters maintain that the Haight Act's in-person encounter requirements have negatively affected the potential usefulness of the telemedicine medium for patients who may have difficulty reaching a practitioner's physical location.

Has Telemedicine Made the "In-Person Medical Evaluation" Requirement Obsolete?

Because of post-1998 developments in communication and other technology, the telemedicine industry and its practitioners maintain that telemedicine allows patients and remotely-located physicians to rely on virtual medical visits that are substantially equivalent to an in-person physician/patient encounter and bear little to no relationship to the pre-Haight Act online questionnaire-based pharmacy model. Current technology allows a physician to both (i) hear patient responses to questions about medical history, present illness, and other routine components of a traditional in-person physician/patient examination, and (ii) make visual observations regarding a patient's physical condition through the video and imaging features embedded within a telemedicine system's hardware and software components. As can be expected, the telemedicine industry and practitioners are very vocal about their shared belief that telemedicine technology has successfully addressed Haight Act concerns about distant physicians who prescribe medications to unseen patients with whom they have no real contact and no legitimate doctor/patient relationship.

Notwithstanding the acknowledged advances in current telemedicine technology, the Haight Act has left many telemedicine providers without the ability to prescribe controlled substances that meet patients' medical needs as directly observed during medical examinations conducted remotely on a telemedicine platform. New rules, expected to be promulgated later this year by the DEA, may help to mitigate this challenge. Likewise, many states, reacting to the expanding relevance of telemedicine, are relaxing rules that similarly limited telemedicine prescribing. Practitioners who engage in telemedicine should closely follow these developments, which may have a critical impact on the permissible scope of their practice.

Potential for New Federal Rulemaking

Recognizing the expanded reach of and interest in telemedicine, and that the limited Haight Act exceptions for telemedicine have not kept up, the DEA announced in 2016 that it will promulgate regulations to establish a special telemedicine registration process contemplated by the Haight Act, potentially allowing a broad range of practitioners to provide telemedicine services that include controlled substances prescriptions without a preliminary in-person evaluation. Such a change could be a tremendous boon to patients whose location or medical condition makes traveling for in-person visits difficult, while continuing to restrict unscrupulous pharmacies and practitioners from engaging in medically inappropriate prescribing via the Internet. However, the new rule, which the DEA originally expected to publish in January 2017, has not yet been released.

Relaxation of State Laws

State law may also pose an impediment to telemedicine practitioners seeking to prescribe controlled substances needed by their patients. However, several states, whether through new laws or through medical board rules, have moved in the direction of loosening these restrictions, and thereby expanding the opportunity for practitioners to offer more comprehensive care to their patients via telemedicine.

Indiana. Indiana recently amended its telemedicine law that had previously prohibited providers from prescribing controlled substances via telemedicine technology. Under the new law, HB 1337, effective as of July 1, 2017, providers may prescribe certain controlled substances via telemedicine, although only under limited circumstances, including that the patient has been examined in-person by a licensed Indiana healthcare provider who has established a treatment plan that will assist the telemedicine prescriber in diagnosing the patient.

Michigan. Recently enacted SB 213 amends a 2016 statute that prohibited providers from prescribing controlled substances via telemedicine. Michigan's new law provides greater leeway for telemedicine prescribing of controlled substances than does the Indiana law, as no in-person visit with a licensed provider is required. Instead of an in-person visit, SB 213 requires that Michigan prescribers act within their licensed scope of practice, meet applicable requirements for prescribing a controlled substance (including those of the Haight Act), provide patients with referrals for other services if medically necessary, and make him or herself available for follow-up care or refer the patient to another practitioner for follow-up care.

Ohio. This year, the Ohio Medical Board promulgated new rules, O.A.C 4731-11-09 and 7331-11-01, for telemedicine prescribing of controlled substances. These rules require prescribers to follow a series of steps to prescribe any drug via telemedicine. Such steps include obtaining identifying patient information (e.g., the patient's physical location), completing an online medical evaluation meeting minimum standards of care, and providing or recommending follow-up care as needed. To prescribe a controlled substance, the prescriber must also fall within one of six situations, like the Haight Act exceptions described above.

Florida. In 2016, the Florida Board of Medicine amended its rules on telemedicine prescribing by implementing Rule 64B8-9.0141, F.A.C. Previously, the Board had banned any prescription of controlled substances using telemedicine; the new rule allows telemedicine prescribing except in the case of controlled substances prescribed for the treatment of psychiatric disorders.

Delaware and West Virginia. Some other states have already addressed controlled substance prescribing through more comprehensive telemedicine laws. In 2015, Delaware adopted a telemedicine law (HB 69) that allows prescribing of controlled substances via telemedicine after a valid physician-patient relationship is established; no in-person visit is required to establish this relationship. West Virginia adopted a telemedicine law in 2016 (HB 4463) that allows for telemedicine prescribing of certain controlled substances without an in-person exam if certain conditions are met.

This growing trend to expand the circumstances under which practitioners can prescribe controlled substances needed by their patients will continue to increase the permissible scope, and therefore usefulness, of telemedicine services. Particularly in combination with potential new Haight Act rules, these changes at the state level may have an important impact on the care that telemedicine practitioners can offer their patients. Practitioners should devote careful attention to potential developments, at both the state and federal levels, over the next few years.

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
Events from this Firm
14 Aug 2018, Seminar, Los Angeles, United States

August 14, 2018 - Orange County
Embassy Suites Anaheim Hotel - Garden Grove

August 21, 2018 - Pasadena Area
DoubleTree by Hilton Hotel - Monrovia

September 20, 2018 - Los Angeles
Sheraton Gateway Hotel - LAX

15 Aug 2018, Seminar, Los Angeles, United States

August 15, 2018 - Orange County Embassy Suites Anaheim Hotel - Garden Grove

August 22, 2018 - Pasadena Area DoubleTree by Hilton Hotel – Monrovia

21 Aug 2018, Seminar, Pasadena, United States

The annual seminar addressing changes and developments in state and federal wage and hour laws is a unique one-day program and hundreds of California employers, personnel managers, controllers, attorneys, payroll managers, and supervisors attend each year.

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