Enforcement Actions: Sanctions and penalties for hiring excluded individuals in healthcare. Why is it crucial to avoid the risk of hiring excluded individuals? List of Excluded Individuals/Entities (LEIE)
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Compliance helps healthcare organizations mitigate risk by building strong relationships and leading through influence for effective regulatory change management
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If you have ever been new to a particular field of the workforce, such as healthcare compliance, you know all too well that the language used by coworkers can sound foreign, like gibberish, or “alphabet soup.” As we continue to work in the field though, we too, start speaking the language. However, while that may be ok for conversing in the compliance department, it still be confusing if we are trying to communicate with, or to educate, other functional areas of the healthcare organization. Without knowing the terminology, the message we are trying to convey is unlikely to be understood when received.
Alphabet Soup
Take a look at an example of terminology just starting with the letter “A” from the Office of the Inspector General Work Plan (reference below):
Say I am talking to another seasoned compliance professional in front of a new employee. Using the above “A” acronyms only, the conversation may sound something like this,
“Based on the billing audit, I see we are not receiving contracted AWP reimbursement under our AI/AN contract for ALF patients with AMD.”
As you can imagine, a new employee might be confused by the acronyms and terms communicated instead of using common business English. Sometimes just saying the entire word instead of the abbreviation is a good place to start, so instead of saying AWP say average wholesale price.
Repetitive Communication
In order to improve communication between seasoned compliance professionals and other members of the organization, it is important to use repetitive teaching strategies. In addition to saying the entire compliance term and the abbreviation, be repetitive and write out the compliance term in addition to the abbreviation in written communications. That way staff become more familiar with compliance terminology and it becomes a part of their daily vocabulary.
Knowledge in Practice
When it comes to any industry, including healthcare, it is easy to throw around acronyms and jargon that is familiar and efficient. However, it is important to be aware of who you are talking to, and therefore make sure they clearly understand whatever it is you are communicating. Translate and reword industry terminology in emails, policies and teaching materials where necessary in order to improve communication and understanding. Better compliance will ultimately be the result.
PRACTICE TIP:
RESOURCES:
Health Care Compliance Association (HCCA) Compliance Dictionary found at https://www.hcca-info.org/publications/compliance-dictionary
Health and Human Services (HHS), Office of the Inspector General (OIG), Work Plan Appendix B: Acronyms and Abbreviations found at https://oig.hhs.gov/publications/workplan/2011/wp09-appx_b_acronyms.pdf
Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and 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.
Compliance departments, generally speaking, guide staff and boards of directors to comply with the requirements, laws and regulations that govern the organization’s business. They also monitor for compliance via internal audits. Risk departments, on the other hand, address ways to mitigate risk to an organization through such activities as the evaluation and purchase of insurance policies. Given the broad nature of the scope of these two departments within the organization, when is compliance and risk collaboration permissible?
Possible collaborations
Collaborations to vet and evaluate permissibility
Goal
All organizations should work to develop a culture where permissible collaborations between compliance and risk occur. They should also make certain that staff feel comfortable calling the compliance or risk department with potential concerns while ensuring the staff not crossing any lines when it comes to compliance or risk department confidential matters or conflicts of interest.
PRACTICE TIP:
Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and 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.
YouCompli enables the compliance officers to assign ownership and oversight of tasks to different department heads, functional leaders, or specialists. The solution prompts users to accept, reject, or reassign the task by a stated deadline. Manage the rollout and accountability of new requirements with the best workflow in the business.
I recently heard the term “moral rebel” while listening to an SCCE Compliance Perspectives podcast. This piqued my curiosity because I wanted to know if a moral rebel was perceived as a positive. In the podcast, Amherst College Professor Catherine Sanderson explained that a moral rebel feels comfortable standing up to a crowd and will call out bad behavior. Similarly, Scott A McGreal in Psychology Today wrote moral rebels have a strong sense of moral identity and are more likely to act morally under pressure. Politics aside, I think we could use more moral rebels right now, especially in our compliance departments. So, how can moral rebels assist our organizations with compliance? Let’s look at a hypothetical case scenario to find out…
Case Scenario – Chaperone policy
Your organization has chaperone policy which requires a chaperone to accompany the provider and patient for any sensitive examinations involving the genitalia, rectum, groin, buttocks or breasts. The policy states the chaperone may be a nurse or medical assistant.
From a compliance and risk perspective, the policy has been implemented to protect the patient, the provider and the organization from potential allegations of inappropriate touching. Education should be done with the providers to ensure the policy is followed regardless of patient and provider gender. The policy is written this way because the anatomical gender may not reflect the gender a patient ascribes to, relates to, or identifies as.
If a sensitive examination needs to be performed, a chaperone must be present during the examination and their name should be documented in the visit note. If, however, after being educated about the need for a chaperone during the sensitive examination the patient declines a chaperone, this should be witnessed by the provider and another staff member and documented in the visit note by the provider including the name of the staff member who witness chaperon declination.
Potential non-compliance with the chaperone policy
Jesse is a medical assistant who works in a pediatric and adolescent clinic. Jesse observes a provider who identifies as male take a patient who identifies as female into an examination room alone. Since Jesse prepped the patient’s chart the night before, Jesse knows the patient is here for abdominal cramps and irregular menstrual bleeding. Moreover, Jesse prepared the exam room to ensure the provider had a speculum and gel available for a vaginal exam. During the patient’s visit, Jesse is never called into the room. While accompanying another patient to the lab for a blood draw, Jesse sees the female patient checking out at the front desk. Jesse wonders who chaperoned the patient’s visit because the only other medical assistant is on lunch break.
Ability to stand up / come forward
In the case scenario above, Jesse would be deemed a moral rebel by speaking up and confirming whether the chaperone policy was followed by the provider. If uncomfortable discussing with the provider directly, Jesse may report concerns to the nurse manager for follow up. In an organization where moral rebels are valued the nurse manager would support a culture where moral rebels are not afraid to come forward if organization policies are not being followed or there was potential harm to a patient or another staff member. Moreover, the nurse manager and compliance would ensure there was no retaliation against Jesse.
PRACTICE TIP:
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.
Revised September 2022
It is incredibly difficult to turn off “work brain” after the day is done. Thoughts and questions keep creeping in during off work time, personal time.
For example, did I send the new state law privacy requirements to our IT security team to review? Are the staff following and appropriately documenting for telehealth reimbursement? Or what should be my priorities on Monday morning? These questions all represent potential weaknesses in internal controls. Let’s explore what can be done to mitigate or decrease any vulnerabilities.
It is important to have appropriate internal controls supported by open communication between colleagues, and forthright reporting to both compliance and risk departments in an organization.
Since organizations are still run by humans, there remains the potential that one human sets up a call to discuss a topic (like a regulatory change), and inadvertently forgets to invite all the other humans affected by the change. Having a process in place where an employee discusses a need to meet with his or her supervisor can help ensure you’ve got the right humans at the table.
Internal controls must also be communicated to the staff so they can adhere to the organization’s expectations and policies. This is where education, early and often, that includes the why behind the internal control, can provide the best results to reducing any vulnerabilities.
Top areas of risk to a healthcare organization include weaknesses or vulnerabilities in security, documentation, operations, and staff performance. Let’s consider the following:
Risk mitigation is an organizational strategy to prevent or decrease the impact of mistakes or unanticipated outcomes when they occur. One strategy is to implement organizational controls, such as PPPs along with checklists and tools, to either prevent or decrease organizational risks.
Proactively setting internal controls helps you and your colleagues address mistakes and errors when they inevitably do happen. While there is no failsafe way to ensure 100% compliance with internal controls, or that all employees will do the right thing every time, you’ll be better positioned when staff are educated and equipped to comply with regulations and do the right thing. And in organizations that have an open culture of reporting, both the risk and compliance teams will be aware of the internal control weaknesses so they can implement mitigation strategies early on.
Strong internal controls are critical to effective regulatory change management. YouCompli can enable your collaboration with compliance champions and free your time to focus on relationships and communications. Take a look at our regulatory change management solution today.
Jerry Shafran is the founder and CEO of YouCompli. He is a serial entrepreneur who builds on a solid foundation of information technology and network solutions. Jerry launches, manages, and sells software and content solutions that simplify complex work. His innovations enable professionals to focus on their core business priorities.
Impact of Risk Liabilities
Unmanaged or poorly managed risk can cause devastating effects to the organization from a reputational and financial perspective.
An extreme example of financial risk, coupled with nationwide reputational risks, was the Tylenol case in the 1980’s. The New York Times describes how, in 1982, Extra-Strength Tylenol capsules were tampered with and laced with potassium cyanide. Seven people in the Chicago area died and copycats caused several more deaths across the U.S. As a result of those incidents, tamper-resistant packaging was created and implemented so over-the-counter products, such as Tylenol, could not unknowingly be laced with a poison which could cause injury or death.
Despite the fact that the manufacturer had not introduced the poison, this event led to huge financial and reputational liability for McNeil Consumer Healthcare, the makers of Tylenol. On just the financial side, this cost a considerable amount of money due to decreased sales and increased advertising costs.
As this example demonstrates, financial and reputational risk for an organization in the healthcare field can have disastrous consequences that threaten to bankrupt or put the organization out of business. If the event or incident is sufficiently egregious, the organization could also face loss of accreditation or state licensure. If this happens, they may also lose Medicare and Medicaid contracts.
Risk Mitigation
Proactive risk mitigation strategies include transfer of risk, through such vehicles as contracts and insurance, and early reporting of incidents or events by staff.
Transfer of risk in contracts in typically done with indemnity or hold harmless clause. Transfer of risk via insurance is done by ensuring the organization has adequate coverages and retentions to meet the organization’s needs.
The intent of an indemnity clause is to transfer the risk of financial loss from one party to the agreement to another party to the agreement. Generally, this is financial losses or expenses caused by contract breach or default, negligence, or misconduct by one of the parties.
Hold harmless language in the contract states one party will not hold another party responsible for potential risks or damages. Hold harmless clauses can be unilateral and apply to just one of the parties to the contract or can be bilateral and apply to both parties to the contract. Typically, bilateral hold harmless language is preferred for healthcare organization contracts because each party will assume their own risk and not sue the other party to the contract for the risk which was assumed.
Early reporting by staff is crucial in order to ensure that appropriate action, discussion, documentation and reporting takes place. Most importantly, this is necessary to ensure that risk mitigation strategies can be implemented to eliminate or decrease risk to the organization.
PRACTICE TIP:
Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and 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.
YouCompli enables the compliance officers to assign ownership and oversight of tasks to different department heads, functional leaders, or specialists. The solution prompts users to accept, reject, or reassign the task by a stated deadline. Manage the rollout and accountability of new requirements with the best workflow in the business.
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:
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:
Areas of risk for a healthcare organization are vast, and can involve injury to persons, property and reputation. Several areas of risk include:
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.
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.
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 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.
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 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.
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.
YouCompli enables the compliance officers to assign ownership and oversight of tasks to different department heads, functional leaders, or specialists. The solution prompts users to accept, reject, or reassign the task by a stated deadline. Manage the rollout and accountability of new requirements with the best workflow in the business.
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?
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.
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.
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 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.
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.
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.
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.