Compliance Perspectives

Post By: Adam Turteltaub

Emmelyn Kim is AVP, Research Compliance & Privacy officer of Northwell Health in Lake Success, New York. She is also the authors of the chapters Clinical Research:  Financial Conflicts of Interest and Clinical Research: Human Research Protections for the new HCCA Complete Healthcare Compliance Manual.

Like the chapters themselves, the conversation in this podcast ventured well outside of the lab into some of the broader issues affecting research, the pandemic and both vaccine distribution and use patterns.

We began with a discussion of the Environmental, Social & Governance (ESG) movement that has grown quickly from an ideal to actual compliance requirements already in many countries. Europe leads in this movement for now, but with so much money at stake it’s increasingly like that businesses in the US, including those in healthcare, will be measured on ESG metrics. At that point, ESG may become a compliance requirement.

Accelerating the trend, arguably, is the overlap in interests between ESG, diversity, equity and inclusion efforts, #MeToo, the Black Lives Matter movement and more recently efforts to stem anti-Asian hate crimes.

In addition, health equity is increasingly seeing scrutiny and concern, with the pandemic having different impacts when assessed by race.

She sees compliance playing a central role in the organizational response to these issues, serving as eyes and ears. Plus, compliance is best suited to spot ethical lapses and respond to them.

Listen in to learn more in this provocative podcast.

Post By: Adam Turteltaub

During the second half of 2020 Gartner Research evaluated the compliance spending of 117 organizations, and the company recently released the interesting findings. Brian Lee, Managing Vice President in the Gartner Legal and Compliance Practice explains in this podcast that their research showed that after three years of strong increases spending plateaued in 2020, no doubt due to the pandemic and ensuing budget freezes and reevaluations.

Of course, he points out, the risks didn’t freeze. In fact, the pandemic created additional risks and came with new requirements in areas like privacy and data security, which led to greater internal collaboration.

Looking deeper into the numbers Gartner found that companies made a shift in how they allocated their budgets. Personnel expenses were roughly the same but companies invested heavily in outsourced solutions, with a 15% increase in spending on technology and a 13% increase on communication and training vendors.

What else has Gartner found? Listen in as we discuss:

* An increased focus on supplier continuity and increased third-party due diligence

* An increase in the use of liaisons to supplement the compliance team

* Privacy spending increasing, and the relationship between privacy and compliance changing

New opportunities for compliance to affect and lead corporate culture.

Post By: Adam Turteltaub

Corporate Integrity Agreements (CIAs) and Integrity Agreements (IAs) are recurring features on the healthcare compliance landscape. To help sort them out and provide a bit of a primer on the topic we spoke with Veronica Xu, Chief Compliance Officer, Sabre Healthcare Group. Veronica is also co-author with Dr. Cornelia Dorfschmid and Nicole Caucci of the article “Government Settlements:  Corporate Integrity Agreements and Integrity Agreements” in the Complete Healthcare Compliance Manual.

A typical CIA has the following requirements, she explains:

* A compliance officer

* A compliance committee

* Policies and procedures

* An education program

* Disclosure mechanism/hotline

* Independent review

* Reporting obligations

In each case these elements of the CIA are customized to the organization and the incident that led to the CIA.

An IA differs in several ways. First IAs are more likely to be called for with smaller, simpler organizations. The length of the term is typically shorter (3 years vs. 5 for CIAs), and the level of monitoring and frequency of review are markedly different.

The relationship with the monitor, regardless of the type and scope of the agreement, is extremely important. The monitor’s job is, as the name says clearly, to monitor the organization’s efforts to the meet the requirements of the agreement. They also review reportable events and other notifications mandated by the agreement.

The level of involvement by the monitor differs widely. In some cases, it may be just a monthly call.  In other cases, the monitor may be much more active, not just monitoring but also providing feedback and pushing the organization to improve its efforts.

The key to a successful relationship with the monitor, Veronica explains, is to be open minded, collaborative, receptive, respectful and transparent. Take a constructive, positive approach and the monitorship can be much easier and leave the compliance program and the organization as a whole in a much stronger place.

To avoid backsliding after the monitorship ends, she advices continuing the relevant practices in the CIA or IA, but don’t keep them static. Make sure they continue to evolve as your risk profile and compliance programs do.

Listen in to learn more, including the importance of celebrating.

Post By: Adam Turteltaub

The playing field for anticorruption never stops changing, with new laws and new risks constantly arising. To help sort things out, and to gain his insight into other compliance challenges, we sat down with Gary Kalman, Director of the US office of Transparency International.

One of the biggest changes in the landscape, he explains is the enactment of a new law in the US, effective January 1, 2021, which implemented a new ultimate beneficial owner (UBO) regime designed to make it harder for individuals to hide behind holding companies.  That law will have three key impacts, he reports:

* It will increase the ability of organizations to understand who they are dealing with in their supply chain

* Aid law enforcement, particularly in the areas of pirated and counterfeit goods

* Make it more difficult for fraudsters to make artificially low bids on government contracts that they have no real plan to fulfill, thereby squeezing out legitimate businesses

He also sees new legislation in Congress that he believes is likely to pass and have an impact on anticorruption efforts. The Foreign Extortion Prevention Act, if passed, will extend anti-bribery prohibitions to the demand side of the equation. The FCPA, of course, is focused on the supply side. The CROOK Act, which stands for Countering Russian and Other Overseas Kleptocracies, would create a fund to help foreign states fight public corruption and develop structures designed to promote the rule of law.

This proposed legislation comes at a time in which corruption has increased as a result of the pandemic. A dramatic rise in government spending has led to an increased number of public tenders globally, with the consequent increase in opportunities for both fraud and corruption.

In sum, it’s a challenging time, and there are reasons for optimism and pessimism. Listen in to see to which side you lean and how you should prepare for what may come next.

Post By: Adam Turteltaub

While the CARES Act provided much needed funding, it wasn’t a handout for healthcare providers. There are strings attached, explains Stephen Shaver, an attorney with Wachler & Associates and author of the Chapter “Revenue Cycle: CARES Act Relief Funds” in the new HCCA Complete Healthcare Compliance Manual.

There are key restrictions under the Provider Relief Fund (PRF) on how the dollars may be used: only to prevent, prepare for and respond to coronavirus. Healthcare providers also may not use any PRF payments for an expense that another funding source has already reimbursed or is required to reimburse.

The risks don’t stop there, Stephen explains. Poor documentation and comingling of the funds can cause compliance issues. To mitigate the risk, he recommends having an adequate paper trail and for compliance team to coordinate their activities with accounting and finance to ensure that there are adequate internal controls in place.

Healthcare providers should also take the time to read the terms and conditions. They are rather specific and contain elements that might not be expected, such as on the use of chimpanzees.

Finally, he warns not to shrug off the power of enforcement authorities. There is potential liability under the False Claims Act and the US Government has vowed aggressive response to misuse of the funding. In addition to the Office of Inspector General at Health and Human Services and the US Department of Justice, Congress created a Special Inspector General for Provider Relief.

Listen in to learn more, and be sure to read the Chapter “Revenue Cycle:  CARES Act Relief Funds” in the new HCCA Complete Healthcare Compliance Manual.

Post By: Adam Turteltaub

The Agencie Francaise Anticorruption, popularly known as the AFA, recently recorded a podcast with us to give insights into its work.

Maria Lancri, a partner at the Paris law firm of Squair joins us in this podcast to provide further light on the activities of the AFA.

As she explains the recently released guidelines reflect both the AFA’s learning and a great deal of input from the private sector. They represent a substantial evolution from the first guidelines, moving from a more theoretical document to one significantly more practical in its approach. The elements of a compliance program have been organized into three pillars:

* Commitment of senior management

* Using risk mapping

* Management of the identified risks

Based on her reading of the guidelines and AFA actions there are several key takeaways that she shares. First is the importance of commitment by senior management. There must be involvement in the program, the board must be overseeing it, and the budget must be meaningful.

Second, the AFA is willing to recognize that a program can be deemed sufficient and worthy of recognition, even if it does not follow the guidelines precisely.

Third, multiple levels of controls are essentials. The AFA even provides a list of potential controls for an organization to consider.

Listen in to learn more of her insights into the expectations and actions of the AFA.

Post By: Adam Turteltaub

As we move ever forward in compliance, sometimes it’s good to stop, look back, and understand the history of compliance programs.

Seth Whitelaw, President and CEO of Whitelaw Compliance Group knows the roots of compliance programs well.  He covers them in this podcast an in the chapter “Healthcare Compliance Programs: From Murky Beginnings to Established Expectation” in the new HCCA Complete Healthcare Compliance Manual.

In our conversation, we start at the beginning for compliance with the birth of the Defense Industry Initiative (DII), which was formed in the wake of the procurement scandals of the 1980s. Today’s commonplace tools such as codes of conducts and helplines can all trace their lineage back to the DII.

Compliance has evolved considerably over the years, and yet resistance remains. As Seth points out some resist because compliance is perceived as being too expensive to do well.  Others resist because they think they are compliant and ethical.

Anyone in the profession knows that even the best companies still face challenges sooner or later. So, too, does the government.

Through the years the government has helped make that point and strengthened the case for investing in compliance. The Sentencing Guidelines laid out an outline for compliance that does not have to be expensive to be effective. The Office of Inspector General at Health and Human Services has fleshed out the Guidelines for healthcare compliance programs, giving much needed direction for this industry. The evaluation criteria from the US Department of Justice has pushed compliance teams to ask fundamental questions of compliance programs and to see if they truly work.

Looking to the future, provocatively Seth sees two potential trends. First is the shift of compliance to a more independent function, potentially one that is outside of the company. The second will be increased used of data, combined with Artificial Intelligence, to automate many of the manual compliance tasks.

Listen in to learn more about where compliance was, where it is now, and where it may be going.  And be sure to check out the new Complete Healthcare Compliance Manual.

Post By: Adam Turteltaub

Few areas of compliance change as rapidly as export controls. People, companies and even countries move on and off the sanctions list. Adding to the complexity, as Matt Silverman, Senior Manager, Compliance & Export Control at ASML explains, is the challenge that an export control violation isn’t about simply shipping goods to someone or somewhere you shouldn’t. Even a conversation, plant tour or the wrong hire can be a violation.

So, how do you stay on top of this issue?

For one, you need a good source of data on who and what entities are on the sanctions list. There are multiple sources that need to be checked regularly includes the Department of Commerce Bureau of Industry and Security (BIS) and Department of State. Plus you will likely need a good vendor with a database of prohibited persons, along with subscriptions to several email lists. And, it doesn’t hurt, as he has done, to join a network of export compliance pros who share the latest information.

Second, it’s critical to work with the business unit to help them understand both the complexities and the need to proceed with caution. At the same time the compliance team needs to stay involved and utilize creative problem-solving skills.

One other discipline, he explains, has to be involved in managing this risk: HR. Hiring a non-US person to work in the company in a sensitive position may be a deemed export and a violation of law. At the same time, though, the company has to be mindful of anti-discrimination laws.

Listen in to learn more about how to manage this complex, ever-evolving risk area.

Post By: Adam Turteltaub

After this podcast, I will never look at a doctor’s office the same way again, and if you are responsible for Stark Law Compliance, your perspective may well change as well.

Goran Musinovic is Vice President of the Realty Trust Group in Knoxville and co-author with Michael Honeycutt and Gregory Gheen of the Chapter “Contracts with Referral Sources:  Real Estate Compliance” in the new HCCA Complete Healthcare Compliance Manual.

Medical office space rentals can trigger Stark Law issues quite easily, he explains. To ensure that it doesn’t, the lease must adequately describe the property; be at least for a year; the premises size may not exceed what is legitimate, reasonable and necessary; space must be used exclusively the lessee, the rent must be fair market value; and it may not take into consideration any referrals between the lessee and lessor.

And that’s just the start.

In addition, compliance teams need to watch for allowances for improvements that do not make sense economically, who is paying for phone, internet and the removal of medical waste, whether the rent is actually being collected, and, if the space is time-shared, whether it is being shared as agreed.

In sum, there is a lot to track. Listen in to learn more, and be sure to check out the new edition of the HCCA Complete Healthcare Compliance Manual.

Post By: Adam Turteltaub

We all want honesty in our lives, and in our workplaces. It can make for all the difference on both a personal and professional level.

For Ron Carucci, Co-Founder and Managing Partner at Navalent, discovering what led people to tell the truth and behave fairly became a mission. He analyzed over 3200 interviews that took place over fifteen years using Artificial Intelligence and identified four factors that correlated to whether people would behave honestly, which he defines as saying the right thing, doing the right thing and doing the right thing for the right reason.  The four factors he found are:

* Clear identity

Meeting the inherent promise of the values statement of the organization and ensuring actions don’t belie those words

* Accountability

Too often accountability has become a negative: scoring people against the wrong measures and putting them through an odious review process, which leads them to dishonest acts to avoid being penalized

* Governance

Here he means not board governance but organizational governance: how we make decisions, allocate resource and set priorities. It needs to be done in a transparent way with reliable data

* Cross-Functional Relationships

When the organization becomes fragmented and there are soon competing truths, conflicts go unresolved. The relationships need to be solid.

According to his research, get these four factors right and the organization is 16 times more likely to have people be honest.

Listen in to learn more a new way to think about creating a more honest organization.