Six Capabilities Needed to Drive Scalable Change Management  

For healthcare compliance leaders, the challenge isn’t just lack of information. It’s a lack of time. 

When a new regulation or update is enacted, the clock starts ticking toward its inevitable effective date and another compliance deadline. Regulatory change management is a moving target with constant deadlines and uncertain task status. 

Without the right tools and systems, all that many compliance leaders can hope for is a link to a government website buried in your inbox from a listserv, or a lengthy regulation that needs reviewed to get started. 

That’s why a modern regulatory change management (RCM) system should do more than just notify you when regulatory changes occur.  

To be truly useful, RCM software needs to transform complex regulations into actionable tasks that clinical and administrative teams can execute without needing law degrees or spending a lot of time extracting all the need-to-implement details.  

Beyond the Regulation: 6 Non-Negotiables for Regulatory Change Management Software 

The shift from uncertainty and static reading material to active management and confident compliance is critical for any modern healthcare system. 

If you’re evaluating a regulatory change management (RCM) solution, look for these six essential capabilities to move your team from “reading” to “doing.” 

Top Requirements for Regulatory Change Management Processes: 

1. Expert-Led Analysis for Continuous Regulatory Intelligence and Monitoring 

2. Efficient Relevance Identification and Assessment Saves Time 

3. Automated Assignment Mapping to Departments, Assignees and Monitors 

4. Workflow Accountability and Oversight for Defensible Audit Trail  

5. Proactive Notification and Escalation Reduce Manual Steps 

6. On-Demand Analytics and Reporting for Actionable Data 

1. Expert-Led Analysis for Continuous Regulatory Intelligence and Monitoring 

Many compliance solutions just offer a link to a government website. That’s not enough for healthcare teams that are already stretched and overworked. Asking a pharmacy director or a head of nursing to read a hundred-page statute on drug pedigree requirements isn’t a sustainable compliance strategy. 

Can It Do the Heavy Lifting? 

A true regulatory change management solution does the heavy lifting for you. A best-in-class solution provides not only the source regulations, but analysis for those regulatory changes relevant to your organization or department.  

This analysis serves as a bridge between the legal language of the regulators and the daily operations of the hospital. Model procedures outline updated provisions of regulatory changes, that is – the requirements, in an operational way.  

From “Legalese” to “Actionable” 

For instance, if a new rule regarding patient privacy in telehealth is released, your software shouldn’t just notify you of the change. The tool should provide a comprehensive overview of what’s included in those changes for you to operationalize. The overview provides all the need-to-know information combined with workflow to assign work and track that it gets done.  

By clearly presenting these tasks, the system reduces the cognitive load on your department heads and ensures nothing is overlooked in the transition from “legalese” to “actionable.” When your team knows exactly what they need to do, the risk of non-compliance drops significantly. 

2. Efficient Relevance Identification and Assessment Saves Time 

Not every regulatory change applies to every organization. Identifying if a regulation or part of one that applies to your organization can take time, resources, and effort to read and see if, how and what applies. A regulatory change management solution should facilitate identification of what’s relevant. Then you can put a quick focus on regulatory changes that specifically impact your organization.  

Capabilities That Reduce Effort Spent Reading Regulations 

Regulation Relevance Check: Your software should guide you through a relevance check and allow you to quickly (within a minute or less), identify if a regulation is relevant or not. 

The “Don’t Know” Button: If a user is unsure of how to answer a question to determine relevance, the software should provide the ability to assign questions to additional staff who have information needed to answer yes or no. Look for a workflow solution that allows you to reach out if you’re unsure of the answer. 

Once the subject matter expert provides their response, you decide if the requirement is relevant as assisted by the question tips. These walk you through the relevance decision-making process.  

The workflow process ends at Step One for requirements that aren’t relevant. It progresses to task assignment and review only for the regulatory work your organization actually needs to get done.  

3. Automated Assignment Mapping to Departments, Assignees and Monitors 

In a busy health system, the person doing the work isn’t always the person who needs to verify that it was done. That creates blind spots and broken workflows. 

Regulatory change management (RCM) software avoids this by allowing you to: 

• Automate Assignments by Department: Assign requirements based on staff department (e.g., pharmacy, radiology, professional fee revenue cycle). 

• Differentiate Roles: Software distinguishes between an Assignee (the person doing the work) and a Monitor (the person providing oversight/cc’d). 

• Set Audit Trails: Every comment and status change should be time-stamped with the username to ensure a defensible record for future audits. 

RCM software reflects your organization’s reality through distinct user roles and automated workflows to them. These roles define who has the hands-on responsibility and who has oversight responsibility, creating a clear chain of command. 

The Role of the Monitor 

The monitor role is an essential feature of modern change management software. Think of this as a structured “cc” function. A department director might need to see that a change is occurring without being the one to upload proof of completion. This keeps leadership informed and accountable without cluttering their daily task lists.  

For instance, a Chief Nursing Officer might want to monitor the progress of a new patient safety protocol across multiple departments without being responsible for each individual task. This separation of duties is a hallmark of a mature compliance program. 

Smart Duplication for Scalable Efficiency 

Also look for “smart duplication” in regulatory change software. For example, if you manage five different hospitals, you shouldn’t have to manually create five identical tasks. An “Assign to All” feature lets you create unique, trackable requirements for each location simultaneously.  

Each hospital administrator receives their own task, but the corporate compliance office can see the progress of all five locations in a single view.  

This maintains centralized oversight while ensuring local accountability. This feature is particularly useful for large health systems that need consistency across dozens of locations and departments while allowing for local execution. 

4. Workflow Accountability and Oversight for Defensible Audit Trail 

The saying goes that if it wasn’t documented, it didn’t happen, and sometimes that applies to healthcare audits. An effective audit trail should be able to reconstruct the entire decision-making process for any given regulation. 

Your software shouldn’t just track completion status. It should capture the entire story of your compliance efforts, providing a clear path for auditors to follow.  

Centralized Commenting Backs Up Workflow Decisions 

Centralized commenting is a key part of a defensible audit trail. Compliance leaders can move away from fragmented check-in emails and internal chat threads. Instead, all discussions regarding a specific regulation live inside a dedicated task workspace.  

This creates a time-stamped, unalterable record of: 

• Who made decisions 
• What questions were asked 
• When work was completed 

If an auditor asks why a certain policy was changed six months ago, you can provide the exact thread of discussion that led to that decision. This level of transparency builds trust with regulators and simplifies the audit process. 

5. Proactive Notification and Escalation Reduce Manual Steps 

Compliance shouldn’t be a surprise. Proactive notification and escalation ensure that deadlines are known and met. A good compliance management system sends automated reminders well before an effective date passes.  

If a task remains untouched as a deadline approaches, the software should trigger a proactive escalation to supervisors. This ensures potential gaps are addressed before they become regulatory violations.  

Automated escalations remove the need for compliance officers to manually follow up with department heads, saving time and reducing friction between departments.  

Proactive Notifications Improve Efficiency 

A static dashboard is where compliance tasks go to die. Instead, look for a dynamic, proactive system that pushes information to your team. With email integration, direct links from an email notification take users straight to their requirement and task workspace in the software. 

6. On-Demand Analytics and Reporting for Actionable Data 

The Analytics Dashboard is designed for what healthcare compliance leaders need to see: 

• What’s overdue?  
• Where do I need to focus?  
• What do we need to do? 

With one click, see everything happening in the workflow, then export important information into spreadsheets or slides for sharing or presenting.  

The outcomes of using a dashboard to manage compliance workflow are: 

• Efficient, reliable access to real-time, high-quality data 
• Simplicity and ease of use save time 
• Visibility and transparency lead to peace of mind 

The ROI of tools like the YouCompli Analytics Dashboard comes from actionable, on-demand information to reduce the risk of noncompliance, fines, and reputational damage. Further value comes from efficient, centralized documentation for details of dashboard information and insights into completed work. 

Next Steps in Your Software Journey: Look for a Partner, Not a PDF Repository 

When evaluating software vendors, ask if the solution actually helps you do the work or does it just give you more things to read. The right regulatory change management software doesn’t stop at sending notifications of regulatory changes. Instead, it actively manages your workload.  

By prioritizing expert analysis, intelligent relevance filtering, and clear role definitions, a good software tool can move your compliance department from an underappreciated burden to a streamlined operational partner.  

A truly effective solution empowers your staff and provides peace of mind to executive leadership. The goal is a culture of compliance where every team member knows exactly what is expected of them and has the tools to achieve it. We share that goal. Reach out if you’d like to know what regulatory change management software can do for you. 

About the Author 

Amy Laufmann, MBA, Client Success Manager at YouCompli, has 10+ years of experience in healthcare compliance leadership and operations in the Pacific Northwest and is passionate about helping healthcare organizations demonstrate the immense value compliance teams provide the healthcare organizations they serve. In her current role, she works with clients to ensure they get the most value out of the YouCompli software and supports compliance leaders nationwide to continuously improve the services and support YouCompli provides. 

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The post What to Look for in Regulatory Change Management Software for Healthcare Compliance  first appeared on YouCompli.

Ensuring medical necessity for services or supplies isn’t just about getting paid. It’s a safeguard against unnecessary or duplicative services that increase the risk of patient harm or medical errors. That’s reason enough for this to be an important topic for compliance leaders. 

This is the first article in a series on medical necessity — an area that many compliance programs struggle with. In this piece, we explain the medical necessity compliance risk in general, while subsequent articles highlight specific examples of enforcement actions experienced by medical providers such as hospitals and health systems. 

Impact of Denial Rates and Medical Necessity on Payer Costs  

Data suggests that medical necessity is becoming a primary way for payers to manage costs, making it even more worthy of leadership attention. The “State of Claims 2025” Report found that 54% of providers agree claim denials are increasing faster than they can appeal. 

A data accuracy gap also contributes to the problem. Roughly 41% of healthcare organizations report at least 1 in 10 claims is denied, often due to “bad data” at intake or lack of clinical justification. 

All of this creates further justification for the need to better understand medical necessity from a compliance standpoint. 

Role of Clinician Review in Determining Medical Necessity 

Medical necessity isn’t an easy compliance risk to tackle, especially when OIG recommendations bump up against front-line reality. Sometimes, clinicians view medical necessity as their bailiwick.   

Of course, their expertise is the basis for medical decision making. Generally speaking, clinicians are making their decisions based on what they believe is medically necessary. They are the clinically trained professionals and should know when something is medically necessary or not, right?  

However, from a compliance standpoint, medical necessity often really means “covered” by a third-party payor. If something is considered “not medically necessary,” it may actually mean it does not meet payor coverage requirements. 

OIG on Clinical Review of Medical Necessity in Claims Audits 

In their General Compliance Program Guidance document (GCPG), the Department of Health and Human Services (HHS) Office of Inspector General (OIG) emphasized the importance of ensuring claims submitted to government payors are medically necessary. 

Specifically, they note:  

“Medicare requires, as a condition of payment, that items and services be medically reasonable and necessary. Therefore, entities should ensure that any claims reviews and audits include a review of the medical necessity of the item or service by an appropriately credentialed clinician. Entities that do not include clinical review of medical necessity in their claims audits may fail to identify important compliance concerns relating to medical necessity.” 

Considerations for Compliance Risks in NCD and LCD 

Other entities have also emphasized medical necessity as coverage criteria. For example, Medicare publishes National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs). These are, in essence, coverage criteria for a specific service.  

Though generally accepted medical guidelines or medical practice may suggest a certain treatment plan is appropriate, the LCD might not cover the service for a particular condition or diagnosis or might not allow the service at a particular cadence or frequency. 

Example: Meeting LCDs for Pain Injection Procedures 

LCDs addressing pain injection procedures are a good example of this. A Medicare LCD might state that before Medicare considers a spinal injection “medically necessary” (think “covered”), the patient needs to have failed four months of conservative therapy (e.g., lifestyle changes, physical therapy, etc.)   

Or the LCD might state a total of four injections in a twelve-month period is the maximum number of injections they will allow. Additionally, an LCD might require that a patient has a certain condition (represented by an ICD-10 or diagnosis code i.e., diagnosis code) before considering a service covered.   

There is potential compliance risk in all these areas if coverage criteria are not met and documented in the medical record or if codes are reported to ensure coverage, but the medical record does not support the diagnosis code reported. 

Overlap with Patient Safety 

Medical necessity can also overlap with patient safety issues. If a physician exaggerates the severity of a condition to make it look like the services should be covered, a patient could undergo a procedure that was not appropriate or medically necessary to perform in the first place.  

This raises patient safety issues for subjecting a patient to certain risks when the service does not appropriately meet clinical standards or indications for performance. 

How Medical Necessity Compliance Is Enforced 

The government utilizes various tools for enforcing medical necessity compliance.  These include the False Claims Act (FCA), typically used by the U.S. Department of Justice (DOJ), and the Civil Monetary Penalties Law (CMPL) utilized by the OIG. 

The DOJ can investigate allegations of medically unnecessary services when credible information is brought to its attention by whistleblowers (qui tam relators). A qui tam relator is a private individual or entity who files a lawsuit on behalf of the government under the FCA against companies or individuals committing fraud. Or the DOJ can investigate on their own, typically because of data analytics they proactively perform. 

How OIG Pursues Financial Penalties and Program Exclusion 

The OIG is authorized to pursue monetary penalties and exclusion through a variety of civil authorities, most notably the CMPL. Under the CMPL, OIG can seek assessments in lieu of damages, Civil Monetary Penalties (CMP), and exclusion from participation in federal health care programs.   

According to the OIG, one example of conduct that could lead to CMP liability is presenting a claim for a pattern of medical or other items or services that a person knows or should know are not medically necessary. 

Medical Necessity Risk Tied to Clinical Services 

There isn’t a one-size-fits-all risk profile when it comes to medical necessity. Each organization’s risk is going to be tied to the clinical services it offers or orders. Organizations and their compliance programs should undertake risk assessments tailored to their particular situation.  

Via the GCPG document, the OIG recommends that when conducting risk assessments, organizations should “ensure that medical necessity, patient safety, and other quality compliance issues are included in the risk universe.” 

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Coming Articles: Details of Recent Enforcement Actions 

In subsequent articles in this series, we’ll take a closer look at the details of recent enforcement actions involving allegations that submitted claims lacked medical necessity. This information will help compliance leaders stay on top of situations and reduce risks in their own organizations.  

Read Part Two Here

About the Author 

CJ Wolf, MD, M.Ed. is a healthcare compliance professional with over 27 years of experience in healthcare economics, revenue cycle, coding, billing, and healthcare compliance. He has worked for Intermountain Healthcare, the University of Texas MD Anderson Cancer Center, the University of Texas System, an international medical device company and a healthcare compliance software start up. Currently, Dr. Wolf teaches and provides private healthcare compliance and coding consulting services as well as training.   

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The post Medical Necessity: A Guide for Healthcare Compliance Leaders  first appeared on YouCompli.

Why Managing Compliance Risk Is Like Eating Spinach 

The overwhelming pace and complexity of healthcare regulatory change have become so routine that the constant grind now poses a distinct compliance risk to the organization it’s intended to protect. 

Yet, many hospitals still treat regulatory change as a routine monitoring activity, failing to adopt the systems thinking and discipline necessary to truly mitigate the risk.  

This article by a top healthcare compliance expert explains what it takes to make that transformation. (She also explains what spinach has in common with compliance risk assessment.) 

Beyond Spinach: A Systems Thinking View of Regulatory Change  

’Tis the season! Compliance risk assessment season, that is.  

Many healthcare organizations are in the middle of this annual “eat your spinach” preventative exercise, with compliance folks wandering the halls asking executives what keeps them up at night.  

This year, a CFO for one of my hospital clients raised a significant risk that is so ever-present it’s often treated as a constant rather than a risk. The pace and complexity of regulatory change in healthcare are so familiar that they’re easy to overlook as a distinct risk.  

Regulatory Change Complexity as Permanent Risk  

For those who do recognize and record risk, this one almost certainly hits near the top of the scoring index. Regulatory change in healthcare isn’t an occasional disruption. It’s a permanent condition of the operating environment.  

Despite recognizing it as a top risk year after year, many organizations still manage regulatory change as a monitoring activity rather than applying systems thinking. Updates are tracked. Summaries are circulated.  

But when change actually occurs, the organization is left to work out (often manually and inconsistently) what the change means and what to do next.  

Systems Thinking Brings Structure to Reducing Compliance Risk 

From a systems-thinking perspective, this is a structural failure, not an execution problem.  

A persistent, high-scoring risk should not rely on individual effort, institutional memory, or ad hoc judgment calls to be managed effectively. It should be supported by infrastructure that reliably converts inputs into outputs.  

In this case, the input is regulatory change. The needed outputs are: 

• Applicability analysis 
• Operational decisions 
• Documented rationale 
• Accountable follow-through 

Failing to Operationalize Compliance Leaves You Open to Risk 

That’s where many regulatory compliance programs feel the strain. The risk isn’t failing to notice regulatory change. The risk is failing to operationalize it in a consistent, defensible way, especially across multiple departments, leaders, and decision points.  

From Effort-Based Compliance to System-Based Compliance 

Coming out of risk assessment season, this creates an opportunity to ask a more fundamental question: Do we actually have a system for managing regulatory change, or do we just know it’s a problem?  

Seen this way, the value isn’t the technology itself. It’s the shift from effort-based compliance to system-based compliance. And with systems and technology, you can do all this in a way that is repeatable and reviewable.  

In short, “eating your spinach” and doing annual assessments is good discipline. Relying on systems is how you stay healthy the rest of the time.  

About the Author 

As principal for AlloImpact LLC, Lisa Estrada provides Strategic Interim Compliance Leadership to hospitals, health systems, health industry vendors, and other healthcare organizations when a leadership vacancy or transition creates an inflection point—turning the moment into an opportunity to pivot, strengthen, and systematize.  

Whether bridging a CCO gap, stabilizing during mergers or growth, responding to heightened regulatory scrutiny, or modernizing a program that’s outgrown its practices, she helps teams build frameworks and cultures that endure. 

Lisa’s work centers on building systems that make compliance durable. By designing and helping teams implement repeatable, resilient processes that scale and stand under scrutiny, Lisa helps organizations move beyond heroics, so compliance keeps working even when key people change. 

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The post From Manual to Scalable: How to Manage Healthcare Compliance Risk  first appeared on YouCompli.

A good healthcare compliance program is all about reducing risk, both in patient care and in financial reimbursement. This detailed blog by compliance expert, CJ Wolf, will bring you up to date on the compliance risks associated with certain anesthesia services.   

The OIG just published audit results and report (July 31, 2025) outlining the issues in this area. This article is a summary of that report, along with what it might mean for compliance professionals.  

The implications can be huge. For example, OIG concluded that Medicare paid $45.7 million for anesthesia services provided during the SPM procedure sessions that were at risk for noncompliance with Medicare requirements.  

What to Know About Anesthesia, Compliance and the Latest OIG Audit 

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently released a nationwide audit report highlighting potential improper payments for anesthesia services provided during select spinal injection procedures  

It is only under rare circumstances that Medicare Part B covers the cost of anesthesia during certain spinal pain management (SPM) procedures. In fact, a prior OIG audit found that 27% of billed anesthesia services during SPM procedures did not have supporting medical documentation that would justify the use of anesthesia.  Given these circumstances, the OIG decided to perform the more recent nationwide audit and publish its findings. 

Goal of OIG Audit Regarding Medicare Part B Payments 

The OIG’s goal in the audit was to identify Medicare Part B payments to physicians for anesthesia administered during selected SPM procedures that were at risk for noncompliance with Medicare requirements. 

The specific SPM procedures included in the audit were: 

• Facet-joint injections 
• Facet-joint denervation (aka radiofrequency ablation) 
• Epidural steroid injections 
• Sacroiliac joint injections 

Medicare Coverage Only in Rare Circumstances 

As mentioned, it is only in rare circumstances that Medicare covers the cost of certain anesthesia services provided during SPM procedures. The types of anesthesia services that could potentially be covered under these rare circumstances include: 

• Moderate sedation: Administration of a drug-induced depression of consciousness during which a patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain the enrollee’s airway, and spontaneous ventilation is adequate. 

• General anesthesia: Administration of a drug-induced loss of consciousness during which a patient is not arousable, even by painful stimulation. The ability to independently maintain breathing is often impaired. The patient often requires assistance in maintaining an open airway that allows for adequate airflow and proper oxygenation of the lungs. Positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. 

• Monitored anesthesia care: This is a specific anesthesia service for a diagnostic or therapeutic procedure. Indications for monitored anesthesia care include the need for deeper levels of analgesia (i.e., the inability to feel pain) and sedation than can be provided by moderate sedation. Monitored anesthesia care falls between moderate sedation and general anesthesia. 

MAC LCDs Published for Select SPM Procedures 

Medicare Part B claims are adjudicated and paid by Medicare Administrative Contractors (MAC).  MACs are charged with ensuring proper payment of claims.  They are to safeguard Medicare funds against improper medical coding and billing, fraud and abuse. One way they do this is by publishing local coverage determinations (LCDs) which outline when certain services are, or are not, covered. 

The MAC LCDs for the selected SPM procedures explain that the use of moderate sedation, general anesthesia, and monitored anesthesia care is usually unnecessary or rarely indicated for these procedures. However, individual consideration may be given in rare cases when documentation clearly established the need for such anesthesia. 

Audit to Confirm Compliance with Limited Coverage Rules 

The OIG wanted to confirm compliance with these limited coverage rules for anesthesia services billed along with the SPM procedures. To do so, they identified an audit period consisting of claims for SPM procedure dates of service between May 2, 2021, and August 31, 2023, during which Medicare paid for 3.9 million sessions of SPM procedures.   

For this audit period, physicians billed for anesthesia services nearly 18% of the time. The MACs paid $46.2 million for the anesthesia services or 99.5% of the time that anesthesia was billed during the same SPM procedure session. 

Then, the OIG identified and selected a nonstatistical sample of 28 sessions where both anesthesia and the selected SPM procedures were billed. To verify compliance, the OIG obtained the supporting medical documentation for these sessions and had an independent medical reviewer determine whether the anesthesia was medically necessary and met the rare circumstances when Medicare would cover the anesthesia service.  

Medical Records Fail to Document Necessity 

For 20 of the 28 sampled sessions, the medical reviewer determined the supporting medical records did not document a rare circumstance in which administering anesthesia was reasonable or necessary for the specific SPM procedure.   

One such example included a session where a physician administered moderate sedation to a patient during an epidural steroid injection session. The medical records provided by the physician stated that this type of anesthesia was administered because of the patient’s anxiety, which is not a medically necessary indication meeting coverage criteria according to the LCD. The medical records also did not have evidence of failed oral sedation, which could have necessitated moderate sedation. 

The OIG stated they could not provide an overall estimate of improper payments for the entire audit period because the sample they used was a nonstatistical sample. However, they concluded that Medicare paid $45.7 million for anesthesia services provided during the SPM procedure sessions that were at risk for noncompliance with Medicare requirements. 

OIG Recommendations Include Provider Education 

One of the more significant recommendations the OIG made for CMS and the MACs is to  

• Educate providers on the coverage criteria 
• Review claims for improper billing of anesthesia services 

For providers, this means your MAC may begin auditing such claims. 

Compliance Tip for Anesthesia Billing 

Compliance professionals should assess how often their organizations bill anesthesia services at the same time as the SPM procedures and review the medical records to determine if the sessions meet the rare circumstances found in the LCD requirements for coverage of both services. 

More Resources about Compliance Risks 

Continue learning about the complexities of Medicare reimbursement and compliance in these other piece by CJ Wolf. 

Compliance Risks Associated with Outlier Payments 

In some circumstances, payers like Medicare, for example, will reimburse additional amounts beyond the prospective payment rate. These additional payments are called “outlier payments.” Outlier payments provide additional reimbursement for cases of exceptionally costly treatments.   

How to Avoid Compliance Risk in Peripheral Vascular Reimbursement   

Peripheral vascular disease (PVD) reimbursement is fraught with potential compliance pitfalls. This expert-written blog addresses the pressing concern of compliance risks in PVD reimbursement. It provides insights into regulatory trends, recent investigations and best practices. It provides insights into regulatory trends, recent investigations and best practices. 

CJ Wolf, MD, M.Ed. is a healthcare compliance professional with over 22 years of experience in healthcare economics, revenue cycle, coding, billing, and healthcare compliance. He has worked for Intermountain Healthcare, the University of Texas MD Anderson Cancer Center, the University of Texas System, an international medical device company and a healthcare compliance software start up. Currently, Dr. Wolf teaches and provides private healthcare compliance and coding consulting services as well as training.   

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The post Know the Compliance Risk for Certain Anesthesia Services  first appeared on YouCompli.

In this blog, experts offer the real scoop on audit readiness in healthcare. Learn the unfiltered truth about compliance audits and what audit etiquette means. Get essential tips on preparing for audits, the role of healthcare compliance auditors, and what to do (and what not do) during an audit.  

What Does Audit Readiness Mean? 

Let’s say a regulator shows up at your door tomorrow. What’s the first thing your team scrambles to find? Is it evidence of task completion? Maybe a list of applicable regs? Updated policies? How about proof of communication to stakeholders? We saw a post this week asking for a current audit preparedness playbook because so many organizations think they’re ready, until they aren’t. 

Raw Truth about Compliance Audits 

Here’s the raw, unfiltered truth; no organization is ever ready for an external auditor or inspector. Ever. If you were, no one would panic when the FDA shows up at the door unannounced, or the state shows up in your lobby. “The state showed up the other day, and I knew why they were coming so I wasn’t unprepared.”  

The truth is you do your best, and you also expect the worst because they’re an auditor or inspector. Duh. It’s what they do.  

It’s like when you hear a funny rattle in your car. You take it to the mechanic. You know he’s gonna find SOMETHING. That’s his job. If you didn’t hear the rattle, you wouldn’t have taken it to him. You’re just hoping it is a minor repair rather than a total overhaul. Same with your audit, your auditor, and the rattle in your compliance practices. 

What to Know About the Healthcare Compliance Auditor 

Auditing is a formal, independent way to investigate regulatory compliance of a system or process within an organization. In accordance with regulations or industry best practices, an auditor assesses the adherence, adequacy and absence of certain processes.  

What a Healthcare Compliance Auditor Does 

• Identifies errors, omissions and irregularities.  
• Investigates the intent of possible wrongdoings. 
• Provides information regarding auditing procedures.  
• Submits reports to investigating authorities. 

Okay, A Compliance Audit Is Scheduled – What to Do? 

Once you know an audit is coming, use these five steps to prepare your organization. 

1. Make sure you can have as many of your team members available for the audit as possible, in case the auditor wants to schedule interviews with them.  
2. Provide a few date options for the auditor to choose from. A regulatory body like CAP, CLIA or FDA does not have to give warning of an audit and can arrive unannounced, but most audits are not unannounced. You have time to prep. Use it.  
3. Ask for an audit agenda as soon as you can. Review it.  
4. Alert the team that an audit will occur. This allows time to prepare any project-specific documents that may not be complete.  
5. About a week out from the audit, do a facility walkthrough to make sure there is nothing out of place. Do it two days out and then the day before. Yes, this much. You have people in your office. They move things.  

Once you have these steps under control, preparation becomes a case of do’s and don’ts. In other words, audit etiquette. 

What Is Audit Etiquette? Best Practices for Compliance Behavior 

Audit etiquette covers all the best practices required to facilitate smooth external audits. These vary slightly based on the health system’s existing compliance processes and experience facilitating them.  

In most cases though, following these techniques for what to do and what to avoid will drive positive, less stressful outcomes.  

What to Do in a Compliance Audit 

• Do listen to an auditor’s question and think before responding.  
• Do answer only the question that is asked. Stop talking.  
• Do ask for clarification if you don’t understand the question.  
• Do answer only those questions relative to your job.  
• Do be honest and pleasant. 
• Do treat the auditor with respect and courtesy at all times.  
• Do dress in business casual attire. 
• Do prepare to talk to the auditor and anticipate questions. 
• Do have quality obtain copies of taped conversations. 
• Do provide well-ordered, clear documents. 
• Do understand your policies and procedures. 
• Do keep computers locked when away. 
• Do close security-controlled doors. 
• Do keep paperwork organized and out of sight when possible. 
• Do escort the auditor at all times while on the premises. 

What Not to Do in a Compliance Audit 

Don’t guess. Say you don’t know or that you need to consult an SOP or defer to someone who is more suitable to answer the question. If you want to consult an SOP, describe the procedure in general terms with the auditor and then walk them through the details. Just saying “I have to consult my SOP” gives the impression that you aren’t trained. 

Here are other things NOT to do in an audit:  

• Don’t try to answer for someone else. 
• Don’t answer for another department or specialty. 
• Don’t offer additional information. Again, stop talking.  
• Don’t elaborate – answer only what is asked. 
• Don’t use hedge words (examples: I think, usually, normally). 
• Don’t guess when asked a question. 
• Don’t sign anything without legal approval.  
• Don’t argue with the auditor or inspection. Clarify anything the auditor misunderstood.  
• Don’t be rude or disrespectful to the auditor. 
• Don’t huddle. 
• Don’t panic. 
• Don’t lie. 

Practice Compliance Audit Etiquette with Confidence 

Regulatory bodies will give a report prior to leaving the audit. Ensure you engage with the necessary teams to give sufficient responses and have a plan for any noted observations. The observations and responses in a report will generally be the first items looked at in the next audit. Make sure you stay on top of these action plans and complete the items you have committed to. 

Also remember that auditors may be experts or novices based on the type and scope of the audit being performed. Do not assume you are the smartest person in the room when communicating with an auditor. Understand that the inherent authority of the auditor is dictated by the interested party they are advising. Their ability to influence a decision (that may have a significant impact on your organization) is the foundation of a desired outcome for you. That’s one reason why we recommend practicing good audit etiquette. 

More Resources about Compliance and Audit Readiness 

• Three Strategies to Align Compliance with Revenue Cycle 
• Audit Expectations and Challenges 
• Healthcare Audit? Stay Ready. Don’t Get Ready. 
• How to Use TPE Plans for Compliance Auditing and Monitoring 

John R. Nocero, Ph.D., and Andrea L. Bordonaro, MAT, blog on LinkedIn as “The Q-Kids,” discussing everything related to clinical research education, inspiration, and professional connection. 

Andrea has taught first grade in Willoughby, Ohio for 27 years in the same classroom that she attended school as a child. She earned a Bachelor of Science in elementary education with a minor in language arts from John Carroll University and a Master’s Degree in the Art of Teaching and Education from Marygrove College. 

John builds and fixes quality departments, while currently thriving as the Administrator & Director of Quality, Risk Management and Compliance at River Vista, a behavioral hospital in Columbus, Ohio.

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The Q-Kids – John R Nocero and Andrea L Bordonaro – are experts at everything quality, regulatory, education training and compliance and love sharing their knowledge on YouCompli.

Follow them on LinkedIn – for more quality content or send them a message – they’d love to hear from you.

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A conflict of interest (COI) in healthcare occurs when a person or organization involved in medical decision-making, such as a doctor, researcher or healthcare administrator, has a secondary interest (financial, professional or personal) that could compromise or influence their objectivity and clinical judgment.  

This secondary interest has the potential to affect decisions about diagnosis, treatment, or research in a way that’s not aligned with the best interests of the patient or public health.  

Key Components of a Conflict of Interest 

Key elements of a conflict of interest include: 

• Financial ties, such as relationships with pharmaceutical companies or medical device manufacturers 
• Personal or professional relationships that can bias medical decision making 
• Institutional interests that influence financial or strategic decisions 

Why COI Must Be Addressed 

The identification and mitigation of COI in healthcare is critically important because they directly affect the quality of patient care, the integrity of medical research, and the overall trust in healthcare systems.  

Here’s why it’s essential to avoid conflicts of interest: 

1. Protect Patient Health and Safety 

When a healthcare provider has financial or personal incentives that conflict with the patient’s best interests, it could lead to recommendations for unnecessary treatments or suboptimal care. This can directly harm patients, either through unnecessary side effects, prolonged treatments, or missed opportunities for better outcomes.   

Patients trust healthcare providers to make decisions based on their health needs, not on external incentives. If a physician is influenced by financial or personal gain, it undermines this trust and can result in patient harm. 

2. Ensure Clinical Objectivity and Best Practices with Evidence-Based Decisions 

In healthcare, clinical decisions should be grounded in the best available scientific evidence. COI can distort clinical judgment, leading to decisions based on profit motives or personal interests, rather than sound evidence or best practices. 

When decisions are made objectively, based on the best evidence and clinical standards, it ensures optimal outcomes for patients and trust in the system. 

3. Reducing Healthcare Costs by Avoiding Unnecessary Procedures 

COI can lead to overutilization of tests, procedures and treatments that are not medically necessary, inflating healthcare costs for individuals and insurance systems. Unnecessary treatments contribute to the rising cost of healthcare and can create financial burdens on patients, insurers and the healthcare system as a whole.  

Mitigating COI can lower costs by ensuring that treatments are based on necessity and effectiveness, not financial incentives. 

4. Preventing Fraud and Abuse in Healthcare Through Ethical Integrity 

COI can open the door to fraudulent practices, such as billing for unnecessary services, overprescribing medications, or manipulating patient data for personal gain.  

Addressing COIs protects the integrity of the healthcare system, ensuring that resources are used appropriately and that the system is not exploited for financial gain. 

Impact of Conflicts of Interest on Healthcare Systems 

Role of Compliance Officer in COI Management 

The compliance officer helps ensure transparency, ethical decision-making, and accountability, thereby protecting patients and maintaining system integrity. The compliance officer’s role in mitigating COI risk involves: 

Monitoring: Ensuring healthcare professionals and organizations disclose any potential COI, particularly financial or personal interests, that could influence decisions. 

Policy Enforcement: Implementing and enforcing clear COI policies and procedures, including guidelines for recusal or divestment when conflicts arise. 

Education and Training: Providing ongoing education to staff about identifying and managing COI to maintain ethical standards.  

Auditing and Reporting: Regularly auditing practices for compliance with COI regulations and reporting any violations to ensure corrective actions. 

An Unfortunate Example of a Deliberate COI 

In 2015, Dr. Farid Fata was sentenced to 45 years in a federal prison by U.S. District Judge Paul Borman. Dr. Fata, who had built an empire of upscale cancer clinics, intentionally misdiagnosed patients and illegally billed Medicare for the treatment.  

He grossly over-treated, under-treated, and misdiagnosed hundreds of patients by telling them they had cancer when they did not. He administered too much or improper treatment to others who did have cancer and continued to give chemotherapy to terminal patients who no longer needed it.  

Over $34M in Billings from Fraudulent Treatments 

About 550 patients have been identified as victims, with 34.7 million in billings to patients and insurance companies, and 17.6 million paid for work Dr. Fata admitted was unnecessary. Prosecutors say Dr. Fata was notorious for treating all his patients personally and keeping other medical professionals away.

The U.S. Attorney’s office said Dr. Fata, “is the most egregious fraudster in the history of the country, measured not only by the millions of dollars he stole but by the harm he inflicted on his victims.”   

This case is one of the most extreme, but it highlights a powerful conflict of interest where financial incentives result in harmful over-treatment of patients. Financial pressure or incentives, whether directly or indirectly tied to volume of procedures, can lead some physicians to recommend unnecessary treatments. These actions exploit the trust of patients, who rely on the expertise of their doctors for decisions that can affect their health, safety, and financial well-being.¹

Conflicts Embedded in Medical Guidelines and Standards 

A unique and mind-blowing aspect of COI in healthcare that few people realize is how deeply conflicts can be embedded in medical guidelines and “evidence-based” standards themselves, shaping the very definition of disease and thresholds for treatment in ways that drive profit more than health. 

When a physician prescribes a statin or a glucose-lowering drug, it feels like a purely clinical decision. But that decision is based on guidelines often crafted by panels with financial ties to drug manufacturers. Even physicians who believe they’re making objective decisions may be following protocols shaped behind the scenes by corporate influence. 

Medical guidelines—the foundation of diagnosis and treatment—are often written by experts who have financial ties to pharmaceutical or device companies whose products benefit from more liberal definitions of disease.   

The assumption is that practitioners and patients need guidance for medical decision making. But in many cases, it’s the interests of pharmaceutical and medical device companies subtly shaping the physician’s practice by influencing how diseases are defined. It seems like medicine is in control, but often, industry tailors the rules of the game through guideline panels, research funding and educational influence. 

Workforce Awareness Needed to Reduce COI 

Members of a healthcare organization’s workforce need to understand what constitutes a Conflict of Interest. COI occur when personal, financial, or professional interests interfere with objective decision-making that affects patient care, research, or organizational integrity.  

The workforce also needs to be aware of disclosure requirements, because they must disclose any potential COI to the compliance officer or management, especially financial relationships with outside entities. Workforce members have an ethical responsibility to prioritize patient welfare, transparency and integrity over external interests in all decisions. 

How Employees Should Respond to COI Suspicions 

If an employee suspects a COI might be an issue, they should promptly report suspicions to the compliance officer, management or through confidential reporting channels. If they are uncertain, the workforce member can seek advice on whether a situation constitutes a COI and how to proceed. This ensures accountability and maintains ethical standards in the organization. 

A solid conflict of interest mitigation process is crucial for a healthcare organization because it ensures patient safety, maintains ethical decision-making, prevents financial exploitation, and preserves public trust. Without it, the integrity of care is compromised, risks to patient health increase, and the organization’s reputation and legal standing are jeopardized. 

1. https://www.justice.gov/archives/opa/pr/detroit-area-doctor-sentenced-45-years-prison-providing-medically-unnecessary-chemotherapy  ︎

Susan is a healthcare compliance leader with over four decades working in a variety of administrative and managerial capacities, including strategic planning, regulatory oversight, revenue cycle risk mitigation, denial and appeal management, privacy and information security, healthcare advocacy, clinical department leadership, provider practice administration, risk management, and quality outcomes.  Currently, Susan provides compliance and privacy consulting services to a variety of healthcare organizations, including program implementation, policy and procedure development, compliance and privacy training, and regulatory oversight administration.  

Susan is a Certified Internal Auditor (CIA), Certified Healthcare Compliance (CHC), Certified Professional Coder (CPC) and holds a Certification in Risk Management (CRMA).  

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The post Mitigating Conflicts of Interest that Drive Profit Over Health  first appeared on YouCompli.

With its emphasis on risk management, compliance training is pivotal in protecting both employees and organizations from legal and ethical pitfalls. By having a good understanding of compliance, employees help safeguard the company against lawsuits and reputational damage.  

In this practical blog, two experts – one in education and one in compliance – offer advice and analogies to improve your compliance education practices.   

Compliance orientation educates new staff members about company policies, procedures, and various regulations that govern their specific roles. Ongoing compliance training ensures that as regulations evolve, all employees are appropriately educated on implications and requirements. Read on to learn what it takes to consistently hit the mark with all your compliance education.  

Make Employees Fit to Perform with Training and Orientation 

Training and orientation requirements are very much like starting an exercise program. All too often, people want to try the double-split; train twice a day; and eat nothing but cucumbers, fish and broccoli for months on end, when you haven’t worked out since high school. Yo, since high school, bro – and you want to jump into the bodybuilding lifestyle like it’s the deep end of the pool? 

The most important thing really is to not think too hard on any of it because the basic point remains the same: Eat a lot of healthy food and train everything really hard. Eat more and do recovery stuff if you are under-recovering and eat less if you are getting fluffier than you would like. Then do it for years and years and years. 

What Compliance Training and Physical Training Have in Common 

A full employee training program should promote a comprehensive understanding of regulatory compliance and safety, along with continuing education and professional development. Then do it for years and years and years – just like physical training.  

Initial training is the introduction to an employee’s duties, with some sort of competency assessment, if needed. Ongoing courses are typically basic information that employees must complete to finish any job-related training. 

Why Do Orientation Programs Fail? Isn’t it Obvious?  

We’ve explained why training and education for new employees are similar to phys ed programs. So, much like your exercise program, why doesn’t your compliance orientation strategy always work? There are multiple reasons why programs fail. Do any of these sound similar? 

1. Too Much, Too Fast 

Your orientation plan gets done because you have to do one. As we’ve talked about before, these sessions are often “death by PowerPoint” and didactic lectures, and newcomers have no idea what’s going on. There’s so much information being thrown at them rather than interacting that after several days in a classroom, new employees feel like they’re drinking from a fire hose instead of being onboarded appropriately.  

2. Where’s My Stuff? 

We shouldn’t have to say this reason, but it’s true. Sometimes the employee doesn’t even have a defined workspace or workstation when they arrive. Once, when we got to work, the laptop we were supposed to have was still in use by the person we were replacing. We were like, well, how am I supposed to learn then if they’re still working on the computer that I’m going to use? HR was like, just watch them over their shoulder and do that they do.  

All of that left us feeling extremely disillusioned. If you didn’t even plan for us to be there, not to mention, if you can’t provide the basic work equipment, we’ll spend more time trying to find it than actually being productive.  

3. Poor Coordination 

Lastly, a lot of great ideas exist only on paper but are never fully implemented effectively on the ground. For example, you want all the leadership team to present during orientation, but you didn’t really check everyone’s schedule for orientation week.  

Now you have a huge gap in the day when the Director of Healthcare Informatics is supposed to teach, but they’re meeting with the VP of Corporate Compliance regarding consenting best practices. You didn’t know that because you didn’t check, and now you have a lull in the agenda, or you scramble to have other presenters move up, giving them very little time in their work schedule to be ready to present.  

Don’t do this. It’s a knee-jerk reaction that makes you look horribly disorganized, to the point where the employee says, “Why do I want to work here again?” 

What to Do Instead for Strong Compliance Training: Three Tips 

1. Concretely define responsibilities.  

In other words, who is doing what. These duties have to be set in stone. For example, the hiring manager will be responsible for ensuring appropriate training and competency assessments of staff; ensuring all essential staff are trained on appropriate Standard Operating Procedures (SOPs) before performing any work; providing notifications to appropriate departments that a new employee is starting; creating and maintaining job descriptions and ensuring all direct reports are current on all training requirements. We’ve actually seen some hiring managers become responsible for identifying and conducting appropriate competency testing for their employees.  

Yes, you need to get this specific. Otherwise, this won’t work.  

2. Have the organization prepared for their arrival. 

We can’t stress this one enough. For example, before a new employee starts, HR should work with all relevant departments to make sure they’re set up on all applicable electronic systems, such as an Outlook e-mail set up. IT or a reasonable designee needs to be responsible for ensuring the computer set-up is completed; an ID badge is already created, and all applicable accounts are accessible and ready before the employee starts.  

It’s a little thing but it goes a long way.  

3. Make sure the training program is ready. 

Ensure all required training is sent to applicable systems for the new employee, so they don’t have to fumble around for it. Ensure all your presenters are ready, and the orientation schedule is adhered to. If it can’t be for whatever reason, think of additional training tasks you can add, such as a facility tour, Q&A with new employees, department-specific training, or shadowing opportunities.  

This keeps new employees eager to learn, while your experienced employees are still involved in onboarding.  

Don’t Take Shortcuts with Compliance Education

Many people take shortcuts with their exercise programs such as doing half-reps or taking fancy, expensive fat burners. Don’t do the same with your compliance training program, such as giving a few presentations and having them sign off on some SOPs and then tossing them into the fire of a busy shift.  

During the first week of employment, your job is to build comfort and confidence within your employees so they can perform the job. Always remember that some things can be covered in a manual, but it takes time on the floors or at your desk for new employees to pick up the ins and outs.  

Develop the Muscle of Knowledge: Optimize Compliance Training 

By actively committing to effective compliance training, health systems mitigate risks and protect their reputation while empowering employees to uphold the highest standards of conduct.  

Reach out for ideas on how to standardize, track and measure compliance education for your organization.  

And in the meantime, if you’d like to learn a little more on your own, we recommend these resources: 

• Building a Quality Education Program That’s Good Enough 

• Best Practices for Better Training in Healthcare Compliance 

• Best Practices for Documenting Compliance Training in Healthcare 

• Five Strategies for Aligning Human Behavior With Your Compliance Program 

John R. Nocero, Ph.D., and Andrea L. Bordonaro, MAT, blog on LinkedIn as “The Q-Kids,” discussing everything related to clinical research education, inspiration, and professional connection. 

Andrea has taught first grade in Willoughby, Ohio for 27 years in the same classroom that she attended school as a child. She earned a Bachelor of Science in elementary education with a minor in language arts from John Carroll University and a Master’s Degree in the Art of Teaching and Education from Marygrove College. 

John builds and fixes quality departments, while currently thriving as the Administrator & Director of Quality, Risk Management and Compliance at River Vista, a behavioral hospital in Columbus, Ohio.

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The Q-Kids – John R Nocero and Andrea L Bordonaro – are experts at everything quality, regulatory, education training and compliance and love sharing their knowledge on YouCompli.

Follow them on LinkedIn – for more quality content or send them a message – they’d love to hear from you.

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• One Compliance Pro’s Regulatory Change Management Process    by Amy Laufmann, MBA
• Five ways to show how healthcare Compliance delivers value by Jerry Shafran
• Revenue Cycle Management Compliance: Ensuring… by Maya Turner, CPMA, CPCO, CFPC, CPC, CPC-I, AAPC
• 12 key metrics for compliance officers looking to… by Kenneth Zeko, JD, CHC
• Three Strategies to Align Compliance with Revenue Cycle  by CJ Wolf, MD
• How the Three Lines Model Strengthens Healthcare Compliance by Kenneth Zeko, JD, CHC
• Mitigating Conflicts of Interest that Drive Profit… by Susan Thomas
• Transforming Compliance to a Department of Yes  by Lisa Herota, RHIA, CHC, CHPS, CCS Compliance & Privacy Officer
• New Regulation– Now What? Step-by-Step Guide to… by Amy Laufmann, MBA
• Navigating Compliance Responsibility: A Foundation… by Amy Laufmann, MBA

The post Three Tips for Strong Compliance Education Practices  first appeared on YouCompli.

The Nurse Who Slipped Through: A Tale of Missed Screenings and Million-Dollar Consequences 

ABC Health, a mid-sized midwestern provider, was thriving. With a regional flagship hospital, six outpatient clinics, a home health division, and a solid reputation for quality care, the CEO had just signed a five-year partnership with a major insurance network.  

There didn’t seem to be any cause for worry. The compliance officer insisted they ran exclusion screenings every quarter—plenty often, the executive claimed. 

Tech Failure Leads to “Minor” Exclusion Screening Lag 

But in Q3, the exclusion screening software glitched. It missed a monthly sync. Then a second. By the third missed month, the compliance officer dismissed it as “a minor lag,” promising the HR department everything would be rerun soon. 

Unfortunately, even a seemingly small glitch can have major consequences for healthcare compliance. 

ABC Health hired a new nurse in October. Her references checked out. She had a glowing record of employment. However, as it turns out, two years ago, she was convicted of Medicaid fraud while working under a different name in the southwest. She was on the OIG Exclusion List under her maiden name. 

But no one screened her for her maiden name at any time. 

Billings Accrue for Excluded Individual Over 11 Months 

The nurse worked at ABC Health for eleven months. In that time, she administered care to over 200 Medicare patients. ABC Health billed CMS more than $1.2 million for services in which she had direct or indirect involvement. 

In August of the following year, a whistleblower complaint hit the OIG hotline. An old colleague recognized the nurse’s face on ABC Health’s website. An investigation followed swiftly. The OIG cross-checked full names and dates of birth, matched alias records, and confirmed: ABC Health had employed an excluded individual. 

A Perfect Storm of Compliance Failure 

What followed was a perfect storm: 

• CMS demanded full repayment of $1.2 million in federal reimbursements. 
• Civil monetary penalties were levied—$20,000 for each false claim filed involving the excluded nurse. 
• The DOJ initiated False Claims Act proceedings, arguing gross negligence in compliance. 
• The state Medicaid program joined the fray, adding $400,000 in additional penalties. 

As this example shows, the fines, penalties, and reputational damage from exclusion failures are significant.  

Exclusion Screening as Compliance Practice and Risk Protection 

The OIG has the authority to exclude individuals and entities from federally funded healthcare programs pursuant to the Social Security Act and maintains a list of all currently excluded individuals and entities called the List of Excluded Individuals/Entities (LEIE). Anyone who hires an individual or entity on the LEIE may be subject to civil monetary penalties (CMP).  

Exclusion screening is critically important for healthcare provider organizations because failing to do it properly can result in severe legal, financial and reputational damage.  

Here are five reasons why you should take a look at your exclusion screening practices: 

1. It’s a Legal Requirement. 

Federal law prohibits payment by Medicare, Medicaid or other federal healthcare programs for any item or service furnished by an excluded individual or entity. This includes not just direct patient care but indirect services (e.g., billing, transportation, administrative work). 

2. Non-Compliance = Massive Penalties 

If your organization hires or contracts with an excluded individual, you must repay all related federal reimbursements. Plus, you could face: 

• Civil Monetary Penalties (CMPs) — up to $20,000 per item/service 
• False Claims Act liability 
• Exclusion from federal healthcare programs, particularly Medicare and Medicaid 

3. Exclusions Are Not Always Obvious. 

Individuals can be excluded under different names, maiden names or aliases. Not all exclusions stem from obvious crimes. Some involve license issues, fraud or administrative findings. 

4. Exclusions Can Happen at Any Time. 

A person not excluded today could be excluded tomorrow. That’s why ongoing, monthly screening is so essential, not just one-time checks during hiring. 

5. It Protects Patients and Upholds Trust. 

Exclusion screening helps prevent unqualified or unethical individuals from delivering care. It’s a cornerstone of patient safety and organizational integrity. 

Regular exclusion screening isn’t just good compliance practice. It’s a regulatory safeguard that protects your organization from fraud, fines and harm to organizational credibility and business integrity. 

So, What Happened at ABC Health? 

The ABC Health board fired the compliance officer; the CEO resigned, and ABC Health declared bankruptcy within six months. The company’s name became a case study in compliance seminars across the country.  

And in a final twist, what happened to the nurse? She vanished before investigators could issue a subpoena. Her exclusion had never expired.  

Moral of the Story: In healthcare compliance, skipping or delaying exclusion screening isn’t just an oversight—it’s a significant risk with high-stake consequences. 

How to Avoid Exclusion Screening Problems 

How can problems like these be avoided? One way is better tracking and management of compliance processes using a tool like YouCompli. Know what the responsibilities are and verify when they are completed. Then confidently manage ongoing compliance processes to avoid situations like what happened to ABC Health.  

Reference Material:   

• U.S. Department of Health & Human Services. Office of Inspector General. Exclusions Program.   
• Background Information.  https://oig.hhs.gov/exclusions/background.asp  
• Exclusions FAQs.  https://oig.hhs.gov/faqs/exclusions-faq/  
• The HIPAA Journal. “What are the HHS OIG Background Check Requirements?”  https://www.hipaajournal.com/hhs-oig-background-check-requirements/  
• U.S. Department of Health & Human Services. Office of Inspector General. Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs. (May 8, 2013).  https://oig.hhs.gov/exclusions/files/sab-05092013.pdf  

Susan is a healthcare compliance leader with over four decades working in a variety of administrative and managerial capacities, including strategic planning, regulatory oversight, revenue cycle risk mitigation, denial and appeal management, privacy and information security, healthcare advocacy, clinical department leadership, provider practice administration, risk management, and quality outcomes.  Currently, Susan provides compliance and privacy consulting services to a variety of healthcare organizations, including program implementation, policy and procedure development, compliance and privacy training, and regulatory oversight administration.  

Susan is a Certified Internal Auditor (CIA), Certified Healthcare Compliance (CHC), Certified Professional Coder (CPC) and holds a Certification in Risk Management (CRMA).  

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The post Exclusion Screening Failure Causes Compliance Nightmare  first appeared on YouCompli.

Traditionally, many healthcare compliance programs have left the work of patient safety and quality to other departments. However, according to the Health and Human Services (HHS) Office of Inspector General (OIG), “Entities should incorporate patient safety/quality oversight into their compliance programs.”   

OIG’s recent emphasis on patient safety and quality is not necessarily a call for compliance programs to take over these efforts. Rather, it’s a reminder that a compliance program should be designed to address the significant risks health care organizations face, which includes patient safety and quality of care.  

How to Incorporate Quality and Safety into Compliance Practices 

How can your compliance program answer the OIG’s call and include patient safety and quality in your oversight efforts? This blog explores four practices to integrate safety/quality concerns into compliance practices. 

1. Build a Strong Compliance Committee 

2. Provide Safe Reporting for Safety/Quality Concerns 

3. Get Your Governing Board Involved with Quality of Care 

4. Nurture Relationships with Quality and Safety Leaders 

Four Ways to Drive Greater Connection Between Compliance and Safety/Quality 

1. Build a Strong Compliance Committee 

Most mature compliance programs have a compliance committee in some form or fashion. To build stronger safety and quality representation, include individuals responsible for quality assurance and patient safety as members of the committee. 

A strong compliance committee should ensure that appropriate auditing and monitoring of patient safety and quality take place on a regular basis. The OIG goes as far as suggesting that “Compliance committees of entities directly furnishing patient care, particularly entities such as hospitals, long-term care facilities, and other entities providing residential care, should also assess staffing for nursing, therapy, and other clinical services to ensure that the entity has the appropriate quantity, quality, and composition of care providers.” 

2. Provide Safe Reporting for Safety and Quality Concerns 

Compliance programs establish lines of communication for reporting concerns, and anyone aware of patient safety or quality concerns must know how to report such incidents or issues. They must also have confidence they won’t face retaliation.  

Awareness of incidents involving safety or quality is often the first step in developing a correction plan, so it’s essential that those who report know how their information is protected. 

Steps have been taken at the federal level to encourage reporting and analysis of medical errors. The Patient Safety Act and Rule provide federal privilege and confidentiality protections for patient safety information called the Patient Safety Work Product (PSWP). PSWP includes data, reports, records, analyses and written or oral statements related to patient safety events.  

More about the types of protections at the federal level can be found here: https://www.hhs.gov/hipaa/for-professionals/patient-safety/index.html  

 

3. Get Your Governing Board Involved with Quality of Care 

Governing boards of healthcare entities have ultimate accountability for ensuring quality of care, and their involvement can also ultimately benefit compliance outcomes.  

There are many resources available to educate your board on their responsibilities related to quality. These include: 

• “Corporate Responsibility and Health Care Quality: A Resource for Health Care Boards of Directors”
• “Driving for Quality in Acute Care: A Board of Directors Dashboard”
• “Driving for Quality in Long-Term Care: A Board of Directors Dashboard” 

Read and share these with board members to help them stay informed more easily.  

4. Nurture Relationships with Quality and Safety Leaders 

Compliance departments aren’t expected to take over the detailed, day-to-day management of quality and patient safety programs. However, it’s essential that compliance leaders develop productive working relationships with leaders and in-house experts within the organization’s quality and patient safety programs. 

One way to develop productive working relationships is to better understand what quality and safety leaders do. A good resource for learning more about the standards, goals and language often used by quality and safety leaders is the Institute for Healthcare Improvement or IHI (https://www.ihi.org/).  

This organization offers both introductory, intermediate and advance learning opportunities for those who want to become better-versed in quality and patient safety topics. The IHI Open School (https://www.ihi.org/education/ihi-open-school) is a great place to start. And for those looking for more formal recognition, the IHI offers certifications, such as the Certified Professional in Patient Safety (CPPS). 

Compliance, Quality and Safety — Together for Common Good 

The call for compliance programs to become more involved in an organization’s patient safety and quality efforts is getting louder from agencies such as the OIG. It’s also smart business practice.  

In summary, this blog has covered four ways to begin the process: 

• Considerations for your compliance committee 
• Ensuring confidentiality of incident reports 
• Involving the governing board  
• Broaden understanding of what safety/quality leaders do 

With these practices in your toolkit, you’ll be on the path to a stronger, more effective compliance program.  

And to help with overall regulatory analysis and operations, learn more about how YouCompli compliance software can support your mission. The tools include capabilities to easily map and track responsibilities across functions.  

CJ Wolf, MD, M.Ed. is a healthcare compliance professional with over 22 years of experience in healthcare economics, revenue cycle, coding, billing, and healthcare compliance. He has worked for Intermountain Healthcare, the University of Texas MD Anderson Cancer Center, the University of Texas System, an international medical device company and a healthcare compliance software start up. Currently, Dr. Wolf teaches and provides private healthcare compliance and coding consulting services as well as training.   

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27 Ungated Resources for Compliance Leaders and Teams 

Compliance professionals sometimes feel undervalued in comparison to other functions in their organization. They think leaders and colleagues don’t really understand what they do.  

These resources will help. Packed with ideas, tips and recommendations, these pieces were written by professionals with many years of compliance experience. 

You can quickly skim for articles that relate to your needs and interests. Bookmark this page as a reference for future questions or projects.

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The post Four Ways to Integrate Compliance with Safety/Quality Efforts  first appeared on YouCompli.