How to Address Beneficiary Inducement Questions During COVID-19

McDermott Will & Emery
Contact

McDermott Will & Emery

OVERVIEW


In the midst of the Coronavirus (COVID-19) pandemic, healthcare providers and suppliers will need to make decisions on how to ensure compliance with existing federal fraud and abuse laws while taking swift action to avoid disruptions in the normal delivery of care. While the US federal government has begun to issue limited guidance, there remain a number of outstanding questions. In this On The Subject, we explore scenarios and options that can help providers maintain good “compliance hygiene.”

IN DEPTH


In this unprecedented public health emergency, many healthcare providers and suppliers are facing new questions on how to address compliance with existing federal fraud and abuse laws, such as the anti-kickback statue (AKS; see 42 U.S.C. § 1320a-7b(b)) and beneficiary inducement provisions of the Civil Monetary Penalty Law (Beneficiary Inducement Statute, or BIS; see 42 U.S.C. § 1320a-7a(a)(5)), in the middle of a pandemic that requires swift action to avoid extreme disruption in the normal delivery of care.

For example, how do providers handle patients in financial need with little time to conduct a financial need assessment? How do providers find ways to deliver care to patients while protecting their workforce and those same patients during a time of social distancing that could last weeks?

The government has begun to address some of these issues. On March 17, 2020, the Department of Health and Human Services Office of Inspector General (OIG) issued a policy statement permitting routine waiver of copays for telehealth services (Policy Statement). Otherwise, there is not much precedent or guidance on applying these laws to the many ways this unusual situation is impacting the industry and beneficiaries.

However, there is some existing flexibility within these laws to address many of these questions and situations. While many of these issues are more specifically covered in BIS exceptions than under AKS safe harbors, OIG’s AKS analysis is consistently similar to its BIS analysis. Many situations may not clearly fit within a BIS exception or an AKS safe harbor, but that is not the end of the analysis. Now is the time to review the facts and circumstances and think about how common sense and reasonable mitigation steps can be applied to maintain compliance and also meet patient needs during a crisis. We address the basic framework for this analysis and the most applicable exceptions here.

Is There a Beneficiary Inducement in the First Place?

The BIS prohibits any person from paying or offering any remuneration to a Medicare or Medicaid beneficiary that the offeror knows or should know is likely to influence the beneficiary’s selection of a particular provider or supplier of Medicare- or Medicaid-payable items or services.

Existing Patients

If the patient is a long-established patient of the provider, and the remuneration is geared towards enabling the patient to continue to see that provider during a time when social distancing is recommended or mandated (such as home visits to avoid patients coming into crowded waiting areas), then there is a question about whether the BIS is truly implicated. In other words, is the remuneration being offered in a manner that the provider knows or should know is likely to influence the beneficiary’s selection of a particular provider or supplier to continue to receiving care from that provider? Or, alternatively, is the remuneration being offered to promote social distancing or another societal benefit intended to combat the spread of Coronavirus (COVID-19)?

Similarly, the AKS prohibits remuneration to induce a person, including a patient, to refer others or themselves to someone for the furnishing of items of services paid by federal healthcare programs. Again, if the patient is a long-established patient and the remuneration involved is intended to promote control of COVID-19, there is more likely to be an argument that there is no inducement triggering the AKS.

Also, keep in mind that OIG has also interpreted the BIS prohibitions to exclude offers of inexpensive items or services with a retail value of no more than $15 per item or $75 in the aggregate per patient on an annual basis. (See 81 FR 88368; prior to December 7, 2016, the limits were $10 per item or $50 in the aggregate per patient on an annual basis.) Therefore, remuneration below these thresholds generally requires no further analysis.

New Patients

As to new patients, the analysis under the BIS and AKS may become somewhat more complex, as the risks that the remuneration will be viewed as an incentive to the patient to seek care from the provider become greater. In such scenarios, providers should evaluate the arrangements from both the perspective of the provider and the perspective of the patient. For example, if the provider intends for the remuneration to motivate a new patient to seek care from the provider over another provider based on the remuneration offered, rather than based on the underlying COVID-19-related goals, the arrangement is likely to implicate both the BIS and AKS. Alternatively, if the provider is offering the remuneration with the intention to incentivize behavior that is intended to mitigate COVID-19 for all patients, both new and established, rather than to attract new patients, the risks may be lower.

For example, if the provider is implementing a new care-delivery protocol practice-wide to promote social distancing, such as offering home visits to all patients who may have greater risk of contracting the virus, then there may be an argument that there is no intent to induce the patient to seek care from that provider over another because the practice has changed the way it operates in light of the unusual circumstances posed by the pandemic.

Has the Copay or Deductible Waiver Already Been Granted by OIG?

First, we note that many diagnostic tests do not carry Medicare copays. Further, recent legislation has removed copays for COVID-19 tests. In addition, OIG’s Policy Statement notified physicians and other practitioners that they will not be subject to administrative sanctions for reducing or waiving any cost-sharing obligations federal healthcare program beneficiaries may owe for telehealth services for arrangements that satisfy both of the following conditions:

  1. A physician or other practitioner reduces or waives cost-sharing obligations (i.e., coinsurance and deductibles) that a beneficiary may owe for telehealth services furnished consistent with the then-applicable coverage and payment rules.
  2. The telehealth services are furnished during the time period subject to the COVID-19 national emergency declaration.

For any free telehealth services furnished during the time period subject to the declaration, OIG will not view the provision of free telehealth services alone to be an inducement or as likely to influence future referrals (i.e., OIG will not view the furnishing of subsequent services occurring as a result of the free telehealth services, without more, as evidence of an inducement).

OIG’s statement leaves open the more pressing question about how to enable patients who do not own the technology to conduct a telemedicine visit to receive telemedicine services when telemedicine may be the safest type of services to provide in light of COVID-19. While OIG did not go so far as to say that providing the technology to engage in telemedicine services could never be an inducement, the Policy Statement also does not say it is always an inducement. As a result, providers contemplating providing technology to patients must look for another exception or rely on a reasonable facts and circumstances analysis and risk assessment.

For other items and services, the BIS and implementing regulations contain an exception to the term “remuneration” for non-routine, unadvertised waivers of copayments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable collection efforts. Many providers have a policy on how to evaluate a patient’s financial need. In care situations that may arise due to COIVD-19, however, there may not be sufficient time to assess the patient’s financial situation under the policy. For example, a hospital may not have the time or staff to evaluate patient financial documentation in the timeframe set forth under the policy. In times of emergency, providers may need to make reasonable decisions about adjusting financial need policy requirements, such as obtaining documentation after care is provided.

Does the Remuneration Fit Within an Existing Safe Harbor?

Promoting Access to Care with Low Risk of Harm

The BIS was amended by the Affordable Care Act (ACA) to add an exception to permit “certain remuneration that poses a low risk of harm and promotes access to care” (see 81 Fed. Reg. 88396 (December 7, 2016)). OIG interprets “promoting access to care” as “improving a particular beneficiary’s, or a defined beneficiary population’s, ability to obtain items and services payable by Medicare or a State health care program.” OIG explained that its interpretation encompasses providing the tools necessary for removing “socioeconomic, educational, geographic, mobility, or other barriers that could prevent patients from seeking care (including preventive care) or following through with a treatment plan.”

OIG defines “care” in “access to care” as “access to items and services that are payable by Medicare or a state health care program for the beneficiaries who receive them.” This means that the exception may not cover remuneration that encourages beneficiaries to access services that could promote general wellness, unless those services are covered by the individual’s Medicare or state healthcare program benefit.

OIG stated that remuneration would pose a low risk of harm to Medicare and Medicaid beneficiaries and the Medicare and Medicaid programs by (i) being unlikely to interfere with, or skew, clinical decision making, (ii) being unlikely to increase costs to federal healthcare programs or beneficiaries through overutilization or inappropriate utilization and (iii) not raising patient safety or quality-of-care concerns.

For example, the temporary loan of a limited-functionality smartphone to enable an existing immunocompromised patient to receive telemedicine services during the national emergency declaration should fall within this exception.

Financial Hardship

The ACA also added a “financial hardship-based” exception to protect the offer or transfer of items or services for free or less than fair market value if (i) the item or service is not advertised or solicited, (ii) the item or service is not tied to the provision of other services reimbursed by Medicare or Medicaid, (iii) there is a reasonable connection between the item or service and the individual’s medical care, and (iv) there is an individualized determination of financial need.

OIG explained that items or services may not be “conditioned on” the patient’s use of other Medicare- or Medicaid-reimbursable services but that the item or service must be reasonably connected to an individual’s medical care from both a medical and financial perspective. Again, while this exception requires a financial-need assessment, timing exigencies unique to this pandemic may dictate conducting that assessment at a later time to avoid delays in providing needed assistance to patients to prevent bad outcomes.

Key Takeaway

In the end, providers are faced with the challenge of making reasoned judgments about how to manage the effective delivery of care in a time of crisis and with limited guidance from the government. Keep in mind that under the existing laws not all offers of remuneration to patients are prohibited. Many arrangements that providers may need to put in place to assist in controlling the spread of COVID-19 may not implicate the BIS or AKS and others may fit within a new waiver or existing safe harbor or exception.

For those arrangements that do not meet any of these exceptions, the existing “facts and circumstances” test will apply. Providers should ensure that they are taking appropriate steps to evaluate arrangements that may involve offers of remuneration to patients, but should not view the BIS and AKS as an absolute barrier to arrangements intended to benefit societal aims in “flattening the curve.”

It is important in this time to remember to maintain good “compliance hygiene” when making these decisions by creating contemporaneous documentation to explain the reasons for and intent behind the arrangement. Eventually, this crisis will end. When it does, the government or relators will inevitably raise issues for inquiry. Actions taken today to memorialize the reasons and thought that went into making these decisions will prepare you for that inquiry.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDermott Will & Emery | Attorney Advertising

Written by:

McDermott Will & Emery
Contact
more
less

McDermott Will & Emery on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.