United States: The SUPPORT Act Of 2018: New All-Payor Anti-Kickback Provisions; Broader Telehealth And Other Coverage

On October 24, 2018, the President signed a far-reaching bill addressing issues related to opioid use and abuse—the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 ("SUPPORT Act"). The SUPPORT Act is a combination of seventy unique bills, and consequently includes a broad array of provisions affecting the healthcare industry. Among other things, they encompass new and revised Medicaid, Medicare, FDA, and Controlled Substance Act ("CSA") laws that seek to address the opioid crisis by expanding Medicaid and Medicare coverage for substance use disorder services; promoting the use of telehealth services; adding program integrity measures in the form of new all-payor anti-kickback provisions; and expanding "sunshine" disclosure requirements on pharmaceutical and device manufacturers' arrangements with ancillary health care providers.

The full Congressional summary of the SUPPORT Act is available here. We summarize below some of the changes most significant for the health care industry at large.

New All-Payor Anti-Kickback Provisions Increase Risk Around Referrals for Recovery Home, Clinical Treatment Facilities, and Clinical Laboratories.

Section 8122 of the SUPPORT Act, known as Eliminating Kickbacks in Recovery Act of 2018 ("EKRA"), establishes an all-payor anti-kickback prohibition that extends to arrangements with recovery homes, clinical laboratories, and clinical treatment facilities.

EKRA includes a number of statutory exceptions, and directs agencies to develop further exceptions. Current exceptions in some cases reference and in others differ from the federal Anti-Kickback Statute ("AKS") safe harbors:

General Discounts EKRA excepts from the prohibition discounts obtained by providers or entities under a health care program, if the discounts are disclosed and reflected in the provider's or entity's costs or charges.
Special Discounts EKRA mirrors the federal AKS safe harbor for Medicare coverage gap drug discounts.
Individual Compensation EKRA's compensation exception applies to both employees and contractors, unlike the AKS, which has different safe harbors for employees and for contractors. The EKRA exception requires that compensation not be determined by, or vary with, referrals to a facility, the number of tests or procedures performed, or the amount billed or received from the health care benefit program. Until regulatory guidance is developed, organizations will need to consider, for example, the use of percentage-based compensation, particularly for non-employed sales personnel.
Organizational Compensation EKRA adopts, through cross-reference, the AKS's personal services and management contracts safe harbor.
Patient Copayments or Coinsurance EKRA excepts copayment waivers that are not routinely provided and are provided in good faith. This thematically reflects the Department of Health and Human Services Office of Inspector General's ("OIG") guidance on waivers for copayments under Medicare.
Transfers to Federally Qualified Health Centers that Service Medically Underserved Populations EKRA adopts, through cross-reference, the AKS's federally qualified health center remuneration exception for the transfer of goods, items, services, donations, or loans set out in writing that are medical or clinical in nature and contribute meaningfully to the health center's ability (among other requirements) to serve a medically underserved population.
Alternative Payment Models Payments made as part of an alternative payment model (the shared savings program under Section 1899 of the Social Security Act ("SSA"), a model created by the Center for Medicare and Medicaid Innovation other than a health care innovation award, a demonstration under the Health Care Quality Demonstration Program (Section 1866C of the SSA), or a demonstration required by federal law), or any alternative payment model used by a state, health insurance insurer or group health plan if approved by the U.S. Department of Health and Human Services ("HHS") as necessary for care coordination and value-based care. This exception does not currently have a direct federal statutory AKS counterpart.
Any Other AG-determined Exceptions EKRA allows the Attorney General, in consultation with the Secretary of HHS, to add any other payments, remuneration, discounts, or reduction by regulation.

Significantly, the prohibitions apply with respect to the soliciting or receipt of remuneration for any referrals to recovery homes, clinical treatment facilities, or clinical laboratories, whether or not related to treating substance use disorders. Further, the prohibitions cover the payment or offer of remuneration to induce a referral to, or in exchange for, an individual using the services of, such providers. That is, of course, particularly relevant for any health care provider that has arrangements with these providers premised on existing fraud and abuse laws—those must now be reassessed in light of the new kickback prohibitions. Organizations will, for example, need to assess how these laws apply to inducements provided to patients and interact with the beneficiary inducement provisions of the Civil Monetary Penalties Law. Moreover, compensation arrangements that these homes, facilities, and clinical laboratories have with their sales force will need to be reviewed for compliance with the applicable employee and independent contractor exceptions.

Telehealth Provisions Provide Greater Medicaid and Medicare Reimbursement Opportunities

Medicare currently provides coverage for telehealth services only in geographic regions that are experiencing provider shortages and, even in those areas, requires that beneficiaries receive telehealth services in a designated originating site, such as a physician's office, hospital, rural health clinic, or critical access hospital. The SUPPORT Act eliminates these restrictions for certain services as of July 1, 2019, authorizing Medicare coverage for telehealth services furnished to beneficiaries with substance use disorders wherever they receive services.

Apart from Medicare, Congress has signaled expanded Medicaid coverage for telehealth services involving substance-use disorder treatment, directing the Centers for Medicare and Medicaid Services ("CMS") to issue guidance to states by October 2019 on reimbursement for various substance use disorder services delivered via telehealth. The SUPPORT Act requires CMS to address federal financial participation for Medicaid expenditures related to telehealth services associated with substance use assessment, medication-assisted treatment, counseling, medication management, and adherence to prescribed medication regimes.

The SUPPORT Act also requires the Attorney General to promulgate, prior to October 2019, final regulations under the CSA specifying the limited circumstances in which a special registration may be issued to physicians, nurse practitioners, and other providers to prescribe controlled substances via telemedicine. The regulations would side-step in-person exam and other narrow telemedicine setting requirements contained in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 ("Haight Act"). To date, the Drug Enforcement Administration had not issued final rules under the Haight Act on the application process for such special telemedicine registration.

New Provider Opportunities: Medicare Coverage Expansion for Opioid Treatment Programs and Medicaid Demonstration Project

In addition to the broader coverage for telehealth services described above, the SUPPORT Act expands Medicare coverage to include opioid treatment programs ("OTPs") that deliver medication-assisted treatment to Medicare beneficiaries. Under the expanded coverage, Medicare will pay outpatient OTPs a bundled payment for the furnishing of FDA-approved opioid agonist and antagonist treatment medications, substance use counseling, individual and group therapy sessions, toxicology testing and other items and services authorized by the Secretary of HHS (but not including things like meals or transportation). In the past, beneficiaries of OTPs had to pay out-of-pocket for many of these services, adversely affecting access for Medicare beneficiaries to substance use treatment at OTPs.

The law also directs CMS to carry out a demonstration project aimed at establishing long-term sustainable provider networks to treat substance use disorders treatment and recovery services. Under the demonstration project, CMS must choose ten states and provide a significant federal match of state dollars spent on substance use disorder treatment or recovery services. Overall, this should increase beneficiary access to substance use treatment and recovery services and Medicaid spending for those services.

Expansion of Sunshine Act Reporting Requirements Increases Risks for Manufacturers

The SUPPORT Act expands reporting requirements for pharmaceutical and medical device manufacturers under the Physician Payments Sunshine Act ("Sunshine Act"). The SUPPORT Act requires that, as part of submissions required on or after January 1, 2022, manufacturers report on the Open Payments system any transfer of value to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. This means that, beginning in the 2021 reporting year, pharmaceutical and device manufacturers will need to broaden their recording and reporting systems, while physicians and teaching hospitals will need to expand their Open Payments tracking.

* * *

The SUPPORT Act presents both new opportunities and risks for health care entities. Hospitals and health systems, clinical laboratories, clinical treatment facilities, recovery homes, and physicians. Precise ramifications will become clearer when various agencies promulgate implementing guidance.

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.

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
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.


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.


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