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Organization Liability: Types of Risk (Part I)

Risk is an important concept for compliance professionals working in the healthcare space to understand. After all, there are many times where risk and liability have crossover to compliance.

For example, in response to a suspected email or electronic health record breach, compliance and risk professionals will need to work together. This work will include:

Evaluating the breach
Reporting to the insurance carrier
Collaborating with a breach coach or legal team to ensure the investigation meets legal requirements and timelines
Collaborating with the information technology team and a forensics firm to ensure risk mitigation strategies are implemented and effective

And so on.

Generally speaking, healthcare compliance professionals should have a good working knowledge of organization risks and liabilities, as well as risk mitigation strategies.

This raises two important questions:

What areas of risk do healthcare organizations face?
What are the potential liabilities related to unmanaged or poorly managed risk?

Areas of Risk for a Healthcare Organization

Areas of risk for a healthcare organization are vast, and can involve injury to persons, property and reputation. Several areas of risk include:

Patient safety risks

These include near misses, which are mistakes which almost make it to the patient, as well as events or incidents that do make it to the patient, causing the patient to experience an unanticipated outcome such as a longer hospital stay, disability or death.
For example, a nurse may realize before giving a vaccine to a child that the adult vaccine and dose was drawn up in the syringe instead of the pediatric vaccine and dosage. This would be a near-miss. Along those same lines, a mistake occurs if the adult vaccine dose is actually administered to the child and an allergic reaction occurs.

Operational risks

These include such things as business interruption or supply chain issues. Business interruption incidents may include fire, flood, or pandemic. If the electronic medical record system goes down, and staff have to chart by hand on paper, this would be a business interruption. Supply chain issues can occur due to higher than normal demand or decrease in output by the manufacturer. If an organization cannot obtain needed supplies – such as hand sanitizer or surgical masks – that would be an example of a supply chain issue.

Legal risks

These typically involve lawsuits filed against the organization. Most commonly, lawsuits result from allegations of inappropriate employment practices or medical negligence or malpractice. For example, if a child had an allergic reaction after receiving an adult dose of a vaccine and unfortunately passed away, the parents may file a lawsuit alleging medical malpractice or negligence on behalf of the organization, the provider or the nurse who administered the incorrect vaccine.

Insurance risks

Insurance risks generally stem from a lack of adequate or appropriate insurance coverage or failure to transfer risk. Insurance risks can also connect to legal risks, which can stem from contracts with inadequate risk transfer or failure to conduct due diligence to vet the vendor. In the case of a pandemic, healthcare and other organizations may not have realized that pandemics and resulting business closures may be excluded from their business interruption insurance policy.

Human capital risks

These encompass the inability to hire, contract or retain appropriately trained staff. A lack of ICU level nurses causing staffing shortages would be an example. Human capital risks can also include professional board or licensing complaints against the organization’s doctors, nurses, therapists, or other licensed staff.

Reputational risks

Reputational risks are often forgotten or invisible to an organization until a bad event happens and it is announced to the public – at which point it is too late.

Reputational risk used to be limited to bad publicity which was published in print or reported on television. However, with the increased acceptance and use of social media, reputational risks are more far-reaching than the local newspaper or evening news program, and could potentially have national reach and negative impact on the organization . A newspaper may not run a story about a child who received an incorrect vaccine, but the child’s mother could post to Facebook or other social media platforms that the organization and providers are terrible and not to be trusted.

Practice Tips:

Schedule a meeting with your insurance broker to evaluate your insurance policies by product line (i.e., general liability, property, cybersecurity, etc.) to ensure the organization is adequately covered to protect against most business losses.
Educate staff to ensure they know how and where to report near-misses and mistakes that occur in the organization.
Work with Risk Management to conduct a risk assessment to evaluate organization risks and implement mitigation plans.

Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and owner of Denise Atwood, PLLC
Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.

Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.

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How Do We Modernize Compliance?

Times change and compliance, like all businesses and business operations, needs processes that keep up. However, there are a lot of challenges that we as compliance professionals face when it comes to modernizing our practice. Modernizing compliance means adapting or incorporating requirements, adherence methods and technology to align with current times or requirements.

For example, this could mean learning to effectively audit electronic, instead of paper, health records. Many compliance professionals have also had to adapt to working with a remote workforce, such as billing and coding professionals, as formerly onsite staff have been transitioned out, in favor of a contracted workforce for a third-party company.

With these, and many other, challenges in mind, how do we proactively modernize compliance?

Enterprise Risk Management Planning

One way is to ensure compliance is part of the organization’s enterprise risk management (ERM) plan and business strategy. It is commonly, but incorrectly, believed that an ERM plan only involves the risk management department. An effective and comprehensive ERM plan has to include human capital, operational, financial and strategic domains, as well as addressing legal, regulatory and compliance related domains and issues.

For example, HIPAA or cyber breaches involving PII or PHI can have significant risk to the organization, including reputational, regulatory and financial consequences. Evaluating these compliance-related risks should be part of the ERM planning process, as should the development of strategies in the ERM to mitigate or manage these risks.

Compliance and Education Plans

Another way to modernize compliance is to ensure compliance and education plans are informative, yet easy to understand and follow. Gone are the days where the compliance plan can be over 30 pages long and written in a dense format with little white space. Let’s be honest: other than people in the compliance department, most employees won’t read a 30-page regulatory document which consists of nothing but text.

Compliance Plan

The compliance plan should be developed and laid out in an easy to read format. Graphs and other graphical elements should be included to aid in engagement and learning. And, when including the regulatory language, also include a clear, concrete example of how that applies to the employee.

For example, we all know that HIPAA requires staff to maintain patient privacy. While at work, this includes conversations — so we should not be discussing patients or patient information with co-workers in the elevator or bathroom. Similarly, if a person calls asking about a patient, staff must check the registration or admission system to ensure the patient wants their admission shared with callers or visitors.

If you really want your employees to follow the compliance plan, then craft it with that as your intent. Get two to three volunteers from other departments to review and edit the document with you so you ensure you met your goal to educate employees and modernize the compliance plan.

Education Plan

Education plans need to be developed that align with the compliance plan, but also must be informative and fresh. Employees are no longer interested in sitting down for a half-day session of watching PowerPoint presentations. Select annual mandatory compliance education modules that are engaging and can be completed in 10-15 minutes at one time. Ensure the format is varied with some reading, videos and multiple-choice options which enhance learning. Try incorporating in-person education throughout the year so that your co-workers are updated on any compliance policy updates or regulatory changes. But keep the education to around 10 minutes at a time in an easy to understand and engaging format, so employees see compliance as a resource instead of a department that only delivers bad news or wastes their time.

Data Analytics Processes

To modernize compliance, it is also important to create agile and contemporary data analytics processes. We can’t track all healthcare related regulations on paper or spreadsheets anymore. There are simply too many requirements to follow and too many changes to track.

The COVID-19 pandemic is a perfect recent example. Governors from many states were executing executive orders (EO) on a frequent basis to address COVID-19 related matters. These executive orders addressed such topics as whether elective surgery could or could not be performed, what restrictions were lifted with regards to telehealth visits, and what professional licensing requirements were relaxed. For organizations who have facilities in multiple states, tracking EO alone would be an incredible burden in a paper- or spreadsheet-driven department.

And, regardless of EO, there can be compliance issues related to telehealth visits and the ability to bill for those visits. For example, if a provider tries to deliver an annual Medicare visit via telehealth from California for a new patient in Connecticut.

Technology and Automation

It probably goes without saying, but modernizing compliance fundamentally includes incorporating the use of current technology and automation tools to assist with regulatory compliance and education. There are a number of electronic learning systems which automate compliance education assignment and monitoring. These systems allow compliance professionals to assign required annual training, as well as remedial education, by employee type (nurse, doctor, coder, food service, volunteer, therapist, information technologist, etc.).

There are also a variety of internet-based due diligence platforms to ensure potential vendors and contractors are appropriately vetted before the organization does business with them. And, there are many systems available that track regulatory changes and regulatory activity within your organization. There’s no longer a good reason to not explore the options, and see which tools are a good fit for your department and organization.

Practice Tip:

Depending on the size of your organization, get 3-6 volunteers to review and provide input on your compliance plan and compliance education materials.
Evaluate current technology and automation platforms such as youCompli to help meet your organization’s compliance needs.

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Emergency Preparedness Revisited

Emergency preparedness has always been one of the top concerns of hospital administrators and medical staff, but never has it been more critical. As the the coronavirus pandemic continues to impact the United States, and facilities are struggling to maintain levels of personal protective equipment (PPE) and ventilators, administrators and compliance professionals should also review the updated federal emergency preparedness requirements, published by the Centers for Medicare and Medicaid Services (CMS) in the Federal Register on September 30, 2019.

We previously blogged about these requirements in 2017, but the requirements have changed in the past few years. Here are the four core elements of a hospital’s emergency preparedness plan to handle natural and man-made disasters — and a look at how they are impacted by last year’s final rule revision by CMS:

Risk Assessment and Planning

Commonly referred to as the emergency plan, CMS requires such a strategy to be developed and then updated at least once a year. It is based on certain risk assessments and uses an “all-hazards” approach that focuses on hospital capacities and capabilities, care-related emergencies, equipment and power failures, communication interruptions (including cyberattacks), and interruptions to water, food, and medication supply chains.

A major change to this element involves hospital climate control and power. Facilities are no longer required to heat and cool the building evenly. However, safe temperatures are to be maintained in areas deemed necessary to protect patients, other people in the facility, and provisions stored in the facility during the course of an emergency, as determined by a risk assessment. If a hospital is unable to maintain safe temperatures, it should follow an established plan for a timely relocation/evacuation that avoids patient exposure to harmful conditions. Additionally, hospitals are required to have an essential electric system with a generator that complies with the NFPA 99 – Health Care Facilities Code.

Like before, the plan must include strategies for addressing emergency events and include a process to work in conjunction with local, tribal, regional, state, and federal emergency preparedness officials. But the key change to the all-hazards approach — and this is crucial in light of recent events — is that all participating hospitals must be prepared for emerging infectious disease (EID) threats, such as the coronavirus. EIDs may require modification to standard facility protocols to protect the health and safety of patients and personnel, such as isolation and PPE usage.

Communication Plan

This element received additional fine-tuning. Participating hospitals still must develop a communication plan that complies with local, state, and federal laws and the plan must be reviewed and updated annually. It should now also include the names and contact information of key hospital personnel for local, tribal, regional, state, and federal emergency preparedness officials. And, it should detail how patient care is coordinated within the facility, across healthcare providers, and with local and state public health departments and emergency management systems.

Policies and Procedures

Hospital policies and procedures still must be based on the emergency plan, risk assessment, and the communication plan, and must be reviewed and updated at least once a year. They should address a broad range of topics and situations, including subsistence needs (water, food, medical supplies) of patients and staff, emergency staffing strategies, tracking the location of on-duty staff and patients during emergencies, sheltering-in-place plans, and patient relocation/evacuation plans.

Training and Testing Program

This revised element the result of an additive process. Program development is based on the emergency plan, the risk assessment, the communication plan, and the policies and procedures. As before, the final rule states the program must detail who needs to be trained, describe the frequency of training, how knowledge is assessed, and document how the training was conducted.

During the course of normal events, hospitals are required to annually conduct a mock disaster drill that is either a full-scale, community-based or individual facility-based exercise. In addition, hospitals must also hold a discussion-based tabletop exercise with its senior staff to discuss hypothetical emergency scenarios and reassess policies and procedures. But recent years have not been normal.

Along with the coronavirus outbreak, many parts of the country have suffered from an increase in natural disasters or mass shootings. The final rule revision acknowledges this wide spectrum of emergencies. If there is an event that activates a hospital’s emergency plan, that facility is exempt from holding its annual mock disaster drill for one year following the incident, provided it has written documentation. If a hospital activates its emergency plan twice in one year, it is exempt from both the mock disaster drill and tabletop exercise for one year following the actual events. Again, written documentation of these events and procedures is required.

Maintain Compliance with CMS

Being compliant with the September 30, 2019 final rule is a requirement for your facility’s Condition of Participation (CoP) / Condition for Certification (CfC) with CMS. Failure to comply, even during a pandemic, could thus have significant impact on your organization. The youCompli compliance management software is a powerful tool to help mitigate risk and enable your hospital to effectively implement these, and many other, regulatory requirements. The software is easy to use and quick to deploy, and can be a powerful means to drive efficiencies through your compliance department.

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COVID-19 Testing: New Federal Clarifications for Employers

You’ve probably heard of recent federal legislation affecting insurance coverage for COVID-19 testing and related services, such as the Families First Coronavirus Response (Families First) Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The federal government has taken steps to require certain kinds of insurance plans to provide coverage for testing (and related services) without cost-sharing, prior authorizations, or other medical management requirements.

New Guidance Issued

On June 23, three federal departments — the Department of Health and Human Services (HHS), the Department of the Treasury, and the Department of Labor — issued a second round of guidance on implementing these provisions.

The Centers for Medicare & Medicaid Services (CMS) has published an FAQ specifically related to the Families First Act which contains some useful information related to this guidance. (Click here to read the full document.)

CMS has confirmed that the Families First Act does not require employers and insurers to pay for COVID-19 testing that is not used for diagnostic purposes. This includes back to work purposes or general screening. And there are no exceptions for the uninsured or those receiving Medicaid coverage.

In the case of diagnostic testing, the law allows for quite a broad range of coverage. Tests must be approved by HHS (which includes tests approved by the Food and Drug Administration (FDA) on an emergency or temporary basis). But as long as one of these approved tests is ordered by an attending health care provider, “where medically appropriate for the individual,” then insurers must pay for it. And that’s even if there are multiple tests ordered.

COVID-19 Tests Not Covered

However, for tests that are not for diagnostic purposes, things get more complicated. If employers require their employees to have clean COVID-19 tests before returning to work, there are basically two options, neither of which insurance is required to help with under this legislation:

Pick up the tab for testing themselves, or
Ask employees to either cover it (which can be very expensive) or line up at one of the free public testing sites.

Implications for Compliance

As with most of the regulatory changes related to the pandemic, the devil is in the details here. Staying up to date on the latest guidance and clarification is the only way to be sure that you are providing the correct information to the rest of your organization.

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Understanding and Managing the HIPAA Security Rule

Protecting the privacy of patients is of paramount concern to healthcare organizations today. Data breaches and/or hacking attempts are happening more frequently. Regulatory requirements are constantly changing. And the pace of technology innovations keeps increasing. The penalties, both financial and reputational, can be disastrous for any organization — and its compliance team — that is not prepared and in the know at all times

For example, recently a healthcare institution mailed hundreds of patient statements, containing names, account numbers and payments due, to wrong addresses. The organization believed that, for most of these statements, this was not a reportable breach, because there was no patient diagnosis, treatment information, or other medical information listed.

This was not correct. And the failure to understand the rule and its nuances resulted in a $2 million settlement.

The HIPAA Security Rule is the hedge against that kind of disaster — so grasping its complexity is crucial.

The regulations that comprise the Security Rule are often the most difficult to understand and implement, as every security compliance measure must be carefully monitored and reported. Not only are all healthcare organizations required to meet the standards and legal requirements in the Security Rule, there can also be implementation specifications which include provide detailed instructions and steps needed for compliance.

From an administrative perspective, HIPAA requires a documented framework of policies and procedures. These policies and procedures detail exactly what your organization does to protect key information. For example, policies can outline the requirements for training for all employees, including those who do and do not have direct access to vital patient information.

The documents that outline the policy and procedure framework must be retained for at least six years (although state requirements may mandate longer retention periods). As policies change, so must your accompanying documentation. And to further ensure your compliance, periodic reviews of policies and responses to changes in the electronic patient health information environment are also recommended.

From a security perspective, HIPAA requires a comprehensive evaluation of the security risks your organization faces, as well as the electronic health record technologies your organization uses. This includes a combination of physical safeguards — such as IT infrastructure, computer systems and security monitoring systems — and technical safeguards — such as risk management software, healthcare management software or regulatory software. These safeguards are designed to both protect patient information and control access to it.

Fortunately, the Security Rule allows for scalability, flexibility and generalization. This means that smaller organizations are given greater latitude in comparison to larger organizations that have significantly more resources. HIPAA’s security requirements are also not linked to specific technologies or products, since both can change rapidly. Instead, requirements focus more on what needs to be done and when, and less on how it should be accomplished.

Managing the complexity of the HIPAA Security Rule can be easier. At youCompli, we help you identify, document and monitor your critical HIPAA information. We understand the time and resource constraints that compliance officers operate under — the need for quickly collecting and accessing quality data and reporting it. Our solutions enable you to remain up-to-date with healthcare regulations — what they mean and how to implement them with precision accuracy in cost-efficient and effective ways. Contact us for more information on how to approach and implement the Security Rule and remain in compliance.

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Legal Challenges and the Benefit of a Comprehensive Compliance Program

The list of compliance and legal challenges facing providers, hospitals and healthcare systems over the next year is long:

Physician arrangements and fair market value;
Mergers and acquisitions;
Quality metrics and risk sharing;
Fraud, waste, and abuse;
Coding and billing transactions;
Reimbursement;
Medical staff issues and burnout;
Labor and employment issues;
HIPAA and HITECH; and
Technology and integrated medical devices.

A list like this can seem daunting. However, a comprehensive compliance program with appropriate resources can help avoid disastrous results related to healthcare compliance and legal challenges.

Labor and Employment Law

The Atlantic reported in January 2018, “Health Care Just Became the U.S.’s Largest Employer In the American labor market.” The growth of the healthcare sector brings increased labor and employment challenges. Although the terms are often used synonymously, labor law focuses on groups of workers (think unions and collective bargaining) while employment law focuses on individual workers, (think discrimination of an individual in a protected class).

A comprehensive compliance program will decrease labor and employment law challenges, by ensuring human resource policies and procedures comply with federal and state laws. Moreover, personnel file audits will demonstrate compliance with those laws.

Transactional Law

Mergers, acquisitions, partnerships, joint ventures and U.S. antitrust law

The Agency for Healthcare Research and Quality (AHRQ) reported in its 2018 National Healthcare Quality & Disparities Report that almost 70% of U.S. hospitals and 43% of primary care physicians are part of consolidated health care systems. Consolidations require an astute compliance and legal team to ensure compliance with antitrust law. These transactions continue to draw scrutiny from the Federal Trade Commission due to monopoly concerns.

The challenge for healthcare organizations is even greater when business crosses state lines. The organization must then comply with multiple state laws simultaneously. As part of a comprehensive compliance program, a compliance professional should work closely with in-house or outside counsel to ensure the business transactions and consolidations include a compliance due diligence perspective, for example reports to the board of directors.

Security Law

HIPAA

Compliance is mandatory; failure to comply is an opportunity to ruin an organization both financially and reputationally. Ransomware attacks on healthcare providers through their computers and medical devices are on the rise. While most IT departments focus on HIPAA security for computers, few address security issues with interconnected medical devices.

A comprehensive compliance program will include recommendations to address the management of cybersecurity for medical devices like those outlined by the U.S. Food and Drug Administration (FDA).

Practice Tips

Use of reports to support legal defense of employment or labor law violations, if needed.
Use of notification and management system to prevent legal challenges by providing up-to-date guidance to support compliance activities.
Conduct an evaluation of medical devices in accordance with the FDA FAQ. Disable the voice recognition feature of smart devices while conducting confidential discussions in a room with a smart TV or speaker.

A system such as youCompli is a strong addition to a comprehensive compliance program, providing up to date notifications of regulatory change, as well as full insight and audit of the compliance process.

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Audit Expectations and Challenges

When it comes to hospitals providing best-in-class health care, stress comes with the territory. From stabilizing trauma victims, to accurately distributing medications, to physicians and nurses working long shifts, increased demands are everywhere — including operations not directly involved with patient care. One demand that can turn daily routines completely upside-down and compound stress is an audit. A GRC compliance audit can be conducted internally by various hospital committees or externally, often by government-approved contractors.

Internal Audits

An internal audit seeks to determine if a hospital’s financial and operational controls, and their related policies and procedures, meet compliance and risk management demands.

Based on a hospital’s risk assessment, management develops and reviews the scope and goals of an audit. Running the audit is then delegated to a committee, with the most common committees focusing on:

Patient safety
Nursing staffing
Clinical quality
Medical staff

An internal audit involves interviews and evaluating personnel or procedures. Upon the audit’s completion, a report of its findings is prepared by the appropriate committee and shared with management. Corrective recommendations of action to any areas of noncompliance are collaboratively developed, and a finalized report is presented to the hospital’s board of directors, chief compliance officer, and audit and compliance committee.

The ultimate goal of an internal audit is to improve patient care. Who in a hospital wouldn’t want to improve it, right? But the truth is that an audit can diminish quality of care while it’s in progress. That’s because committees are often comprised of physicians, nurses, and technologists who are pulled away from patient-care responsibilities to work on compliance administrative tasks.

External Audits

According to a 2017 AHA report, four federal agencies — the Centers for Medicare & Medicaid Services, the Office of Inspector General, the Office of Civil Rights, and the Office of the National Coordinator for Health Information Technology — are the primary drivers of regulations and compliance costs across eight domains for hospitals:

Hospital conditions of participation
Billing and coverage verification requirements
Meaningful use of electronic health records
Quality reporting
Privacy and security
Fraud and abuse
Program integrity
New models of care

The frequency and pace of regulatory changes implemented by multiple federal agencies are dizzying. Hospitals are often required to comply with regulations in very short timeframes, requiring a significant investment of staff time and finances. What’s more, responding to multiple external audits increases administrative costs, and funds could be tied up in lengthy appeals processes contesting an auditor’s inappropriate determination.

External audits are conservatively estimated at $100 per hour. For example, consider the total costs of a HIPAA audit:

HIPAA Gap Assessment — Identifies gaps and provides remediation plans for those gaps
(40 hours average, $24,000–34,000)
Full HIPAA Audit — Assesses hospitals against all the requirements in the HIPAA Security Rule
(100 hours average, $30,000–60,000)
Validated HITRUST Assessment — Provides the most complete, certifiable framework for HIPAA to mirror PCI compliance (400 hours average, $100,000–160,000 — with costs much higher for larger organizations)

Protect Your Hospital

If your hospital is like most others, it’s spending too much staff time and money dealing with a blizzard of regulations and an avalanche of red tape. Fortunately, there are solutions. youCompli GRC risk management software monitors, reads, and translates complicated regulations into plain English. Our solution enables you to fully understand which rules are pertinent to maintaining compliance, further simplifying the auditing process. And it tracks everything, from end to end, making audits much less painful.

Learn how youCompli regulatory compliance management software protects your hospital.

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Who Needs an “Easy” Button? Regulatory Compliance for Teaching Hospitals and Academic Medical Centers

Nobody chooses to pursue a career in healthcare at a teaching hospital or academic medical center (AMC) so they could process regulatory compliance paperwork. Right?! Nevertheless, health systems spend $39 billion on admin duties to comply with no fewer than 600 regulatory requirements. Most of the time they are juggling these requirements (and a whole lot more) without an effective compliance management system. It’s anybody’s guess what is truly being done to comply.

The regulatory landscape continues to change. It’s even more complex for teaching hospitals and AMCs that have specialized facilities such as children’s hospitals and cancer centers. And it’s nearly impossible to know for sure what is being done to comply with the regs when students and researchers are added to the mix. Compliance oversight is already challenging enough when it includes only clinical and hospital staff, business associates and contractors.

Ever-increasing regulation ushers in more documentation requirements. Satisfying the reporting requirements steals time away from patient care and contributes to burnout. Plus, more regs and more people equals a big compliance headache.

These healthcare systems not only have the pressure to comply with regulations, improve care and cut costs as other hospitals do, but they have the critical mandate to educate future medical professionals and dedicate resources to research.

According to the Association of American Medical Colleges, academic medical centers in the United States contribute $562 billion in annual economic impact. But, what’s even more significant is the impact these facilities have on the health of our society. Medicine moves forward in teaching hospitals and academic medical centers. When people are faced with a health crisis and grasping for innovative treatment and cures, they flock to these systems. Oftentimes this is their last shot at a healthy future. Teaching hospitals and academic medical centers are the epicenter of first breakthroughs. They are also the last resort for patients who have tried everything else. As a result, teaching hospitals have more costly cases and often bear the brunt of safety-net and charity care.

Shouldn’t there be an “easy” button for them?

Academic medical centers and teaching hospitals have a great need for an effective compliance management system. These systems save valuable time and money. But they also make it easy to see what is being done by whom to comply with regs. No more ad-hoc spreadsheets. Thoughtfully applied technology can make regulatory oversight a piece of cake.

The more effective the compliance management system, the more time is freed up for medical professionals to do what they are passionate about—provide the best patient care and focus on their mission of treatment, research and education. And who couldn’t use an “easy” button for compliance regulation?

Are you ready to explore a compliance management system that is easy to use and effective? If you’re ready to transform your regulatory compliance process, schedule a call today!

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Chief Compliance Officers Can Be in the Cross hairs

Chief compliance officers should take note of two recent enforcement actions in the financial sector.

In these cases, the regulators have gone after the compliance officers (in addition to others).

In the 1^st case, the SEC alleges that the chief compliance officer was “carrying out his compliance responsibilities in an extremely reckless manner.” It further alleges that the cco “was required to review and monitor” trading practices “to make sure they were fair and equitable”. It says, other than occasionally “spot checking” trade paperwork the CCO “essentially did nothing” to ensure the firm’s trading policies and procedures were being followed.

Attorney Brian Daly, a partner in the regulatory and compliance and investment management groups of Schulte Roth & Zabel in New York, called the SEC action “pretty extreme.” (Reisnger, 2019) Daly spent a decade as a general counsel and chief compliance officer at several investment firms before joining Schulte, including at Kepos Capital, Raptor Capital Management and The Carlyle Group.

“It’s unusual,” Daly told Corporate Counsel. “It’s one thing to say he [compliance officer] could be sanctioned or censured, but they are accusing him of recklessly not carrying out his duties because of inaction, and of aiding and abetting bad actions.” (Reisnger, 2019)

The 2nd enforcement case accused the chief compliance officer of allegedly engaging in fraud and then making false statements to the National Futures Association.

In May of this year, the CEO of the firm was charged with allegedly misappropriation, fraud and making false statements. This led to the CFTC ordering the firms cco to pay $150,000 ($125,000 in restitution and $25,000 civil penalty) for fraud and false statements.

Philadelphia attorney Mary Hansen, the co-chair of the white-collar defense and corporate investigations practice at Drinker Biddle & Reath, said (about the 2nd case), the case should serve as a warning to chief compliance officers. “In the last couple years, we’ve seen more compliance officers charged,” adding, “and that’s not going away.” (Resinger, 2019)

While not in the healthcare field these cases and others reinforce the on-going need to create effective compliance programs.

youCompli’s regulatory change management software ensures your program is effectively managing ALL regulatory changes. To see a 2-minute video to learn how and hear from one of our customers click below.

See the Video

Reisinger, S. (2019, Sept. 25) Regulators Put Chief Compliance Officers in Their Sights in 2 Financial Fraud Cases Retrieved from http://www.law.com

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