compliance program Archives - OF DIGITAL INTEREST

DOJ’s Enforcement Activity Against Individuals: Acute Focus on Telemedicine

by Amandeep S. Sidhu, James A. Cannatti III and Theodore Alexander | May 6, 2019 | Telehealth

DOJ’s focus on individual accountability is particularly important with respect to telemedicine. Telemedicine is a burgeoning field, with a projected market increase of 18 percent annually over the next six years, reaching $103 billion in 2024. In light of this recent surge in profitability, DOJ has begun paying extra attention to telemedicine, with at least one recent HHS-OIG report asserting that more than one-third of all telemedicine claims are improper.

The report’s claim is further supported by a recent increase in telemedicine prosecutions. In April 2019, DOJ announced charges against 24 defendants, including owners of various telemedicine companies, for their alleged involvement in a health care fraud scheme resulting in $1.2 billion in loss. This scheme involved the payment of kickbacks and bribes by durable medical equipment (DME) companies to medical professionals working with telemedicine companies, in exchange for the referral of Medicare beneficiaries. DOJ alleges that the defendants paid doctors to prescribe medically unnecessary DME without ever seeing patients or after only a brief telephone conversation. The prosecution involves charges in at least seven districts across the United States, including New Jersey, Florida, Texas, Pennsylvania, and California. Additionally, DOJ prosecuted several other individuals in connection with unrelated telemedicine schemes in late 2018 (see the agency’s press releases here, here and here). In light of this recent trend, companies should exercise extreme caution and consult with regulatory experts prior to opening telemedicine practices. Companies can expect to see increased scrutiny and further prosecution of telemedicine companies moving forward.

Practice Note: DOJ has recently re-emphasized its willingness to exercise significant discretion and reward companies that invest in strong compliance programs. Looking forward, health care companies should maintain detailed and up-to-date documentation of all compliance programs, in case such an FCA case should arise. A lawyer should be consulted if an updated compliance program is needed.

This blog post was originally published in McDermott’s Health Care Enforcement Quarterly Roundup | Q1 2019. Click here to view the full report.

Maximizing the Value of Big Data in Digital Health

by McDermott Will & Emery | Aug 16, 2018 | Big Data, Data Privacy

The interest in leveraging the value of big data in digital health has become a focus of health care industry mainstays and newcomers alike. Within a challenging regulatory landscape, it is critical for those looking to play in this space to be proactive in planning their data strategy, with an eye towards compliance planning and solid due diligence to maximize its value. In this Q&A, big data thought leaders Bernadette Broccolo and Sarah Hogan, both partners in McDermott Will & Emery’s Health Industry Advisory group, discuss the challenges and opportunities that health industry stakeholders face when stepping into the world of big data.

For information on this topic and to hear the full Q&A with Bernadette and Sarah, listen to the newest episode of the Of Digital Interest podcast. You can access the full episode at here or subscribe to the podcast on iTunes, Pocket Casts or Soundcloud.

Q. Where is the value in big data in digital health? Who is seeing value today and what are their motivations?

BB: The best short answer is that everybody is seeing value – both long standing industry players and newcomers. The real value in big data comes not from raw data or just having a lot of data, but in the ability to use it and mine it, to have it in a form that’s analyzable. What’s very surprising too, in addition to the speed with which the interest in big data has escalated, is who is interested. In the past, one certainly expected academic medical centers and universities that have major research initiatives and clinical trial initiatives to be interested. But now others like molecular lab testing organizations, CLIA regulated laboratories and entrepreneurs are interested in capturing data.

SH: I think one of the surprising players is actually the pharma companies. It may sound odd to say that, but they have a lot of data – including a lot of clinical data – that they’re looking at mining to determine how they can target their therapeutics in a way that helps patients more efficiently. They are looking at themselves and asking “What does the 21st century pharma company look like?” (more…)

Cybersecurity Update: U.S. Sanctions on the Horizon for Malicious Cyber-Attackers

by McDermott Will & Emery and Amy C. Pimentel | Apr 21, 2015 | Cybersecurity

Executive Order 13694 is the Obama Administration’s latest tool to combat cybersecurity threats. On April 1, 2015, President Obama declared a national emergency to address the “increasing prevalence and severity of malicious cyber-enabled activities” originating from outside the United States that “constitute an unusual and extraordinary threat to the national security, foreign policy and economy of the United States.”

The order authorizes the U.S. Secretary of the Treasury, in consultation with the Attorney General and the Secretary of State, to impose sanctions, including asset freezes and travel bans, on those persons and entities determined to be responsible for, or complicit in, malicious cyber-enabled activities that have the purpose or effect of:

Harming or significantly compromising the provision of services by entities in a critical infrastructure sector;
Significantly disrupting the availability of a computer or network or computers; or
Causing a significant misappropriation of funds or economic resources, trade secrets, personal identifiers or financial information for commercial or competitive advantage or private financial gain.

Although the order does not define “malicious cyber-enabled activities,” the Department of Treasury, in its online FAQs, anticipates that the order will cover “deliberate activities accomplished through unauthorized access to a computer system, including by remote access; circumventing one or more protection measures, including by bypassing a firewall; or compromising the security of hardware or software in the supply chain.”

This strategic move by the administration is intended to address situations where, for jurisdictional or other issues, certain significant malicious cyber actors may be beyond the reach of other authorities available to the U.S. government. This sanction program does not target nation states, individuals acting on behalf of those nation states, or victims of malicious cyber activities.

Executive Order 13694 in Practice

The Department of Treasury FAQs and the White House Office of the Press Secretary’s Fact Sheet explain how the program will work. According to the literature, the Treasury’s Office of Foreign Assets Control (OFAC), in coordination with other U.S. government agencies, will identify individuals and entities whose conduct meets the criteria set forth in the order. These individuals and entities will then be designated for sanctions and added to OFAC’s list of Specially Designated Nationals and Blocked Persons (SDN List).

Once OFAC determines the specific entities and individuals that are subject to sanctions under the order, all U.S. citizens and permanent resident aliens, all persons and entities within the United States, and all U.S.-incorporated entities and their non-U.S. subsidiaries or branches will be prohibited from engaging in trade or any other transactions with these individuals or entities owned by these individuals.

OFAC cautions that individuals or firms that “facilitate or engage in online commerce are responsible for ensuring that they do not engage in unauthorized transactions of dealings with persons named on the sanctions list or operate in jurisdictions targeted by comprehensive sanctions programs.” At this point, it is unclear how the Treasury will enforce the order and what, if any, penalties will be levied against those not in compliance.

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