About the Medical Necessity Series 

This is the third in our series of articles on medical necessity. In the first, we described the compliance risks associated with submission of claims for medically unnecessary services.   

In the second, we highlighted a case where an organization of long-term care hospitals were alleged to have violated the Federal False Claims Act (FCA) for holding patients in the hospital longer than medically necessary to increase reimbursement from Medicare. 

In this next article, we spotlight another recent example of a healthcare provider entity agreeing to pay a six-figure sum to resolve allegations of submission of claims for medically unnecessary services¹.  This time, the providers consisted of three affiliated skilled nursing facilities (SNF) that were alleged to have submitted claims for medically unnecessary rehabilitation services.   

False Claims Act Metrics Make Significance Clear 

The Department of Justice has reported that False Claims Act settlements and judgments reached $6.8 billion in Fiscal Year 2025. Over $5.7 billion of that total was derived entirely from the healthcare sector. Most of these healthcare recoveries stem from whistleblower lawsuits targeting corporate billing schemes, upcoding, and medically unnecessary services. 

Case Involves SNF Reimbursement Dispute Over Therapy Services 

For the period in question, skilled nursing facilities (SNFs) were reimbursed for therapy services based on a patient’s resource utilization group (RUG). The RUG was determined by the amount of services the patient received, such as: 

•  Physical therapy 
• Occupational therapy  
• Speech pathology services 

In short, the more services provided, the higher the reimbursement.  However, as discussed in our two prior articles, if the services don’t meet medical necessity requirements, they should not have been performed or billed in the first place. 

Whistleblower Lawsuit Triggers Investigation 

As is frequently the case, these allegations were first brought forth through a qui tam, or whistleblower, lawsuit. The whistleblower, or relator, claimed the defendants implemented a five-pronged scheme to fraudulently bill for unnecessary “Ultra High Rehab,” (the most intensive therapy provided by SNFs) and to keep patients in Ultra High Rehab for longer than necessary. 

The five prongs of the alleged scheme were: 

1. Pressure to perform excessive, unnecessary services: The organization’s leadership exerted pressure on therapy staff to administer excessive Ultra High Rehab and to do so for longer than necessary.   

This pressure was exerted not only by administrators who oversaw SNF operations, but also by regional directors of operations who managed the facility administrators. Such pressure was also exerted by directors of rehab (DOR) who managed therapists at each facility, and regional managers who directly managed the DORs.  

In other words, management, from top to bottom, spoke to therapists and staff in one voice: increase Ultra High Rehab, regardless of patient need. 

2. Financial vs. medical reasons to provide care:  Instead of letting therapists determine the appropriate level of therapy needed based on their professional evaluation, leadership insisted that each patient’s level of therapy be at least in part determined by whether the patient qualified for lucrative Medicare Part A benefits. 

3. Care for functional patients: The organizations pressured therapists to continue providing therapy to patients who were fully functional and in no way required intensive therapy. A scheme called “Bridge to Success” was employed which mandated an additional week of Ultra High Rehab be tacked on even after patients were ready for discharge. 

4. Too sick for care: The organizations pressured therapists to provide therapy to patients who were too sick to benefit from therapy and even to patients who were actually harmed by it.  

Since therapy minutes were dictated by management and not assigned based on the professional opinion of evaluating therapists, patients ended up receiving more therapy than they could tolerate, including instances where therapy was forced on patients about to pass away. 

5. Maximizing minutes: The focus on maximizing therapy minutes to hit therapy goals also resulted in leadership encouraging an array of fraudulent billing practices. 

This included: 

• Billing non-therapeutic minutes as therapy  
• Allowing therapists to bill for therapy without actually providing it 
• Encouraging therapists to bill evaluation sessions as therapy. 

Widespread Occurrences Involve $14.6+ Billion in Alleged Intended Losses 

Federal enforcement actions emphasize the commonality of these practices. The 2025 National Health Care Fraud Takedown alone resulted in criminal charges against 324 defendants nationwide, involving over $14.6 billion in alleged intended losses tied to fraudulent billing and medical necessity abuses. 

The most compelling argument for compliance leaders is that medical necessity fraud carries dual liability: 

• Financial Risk: Organizations face mandatory treble damages (three times the government’s actual loss) plus steep statutory penalties for every individual false claim submitted. 
• Human Risk: Unlike administrative billing errors, medical necessity fraud directly compromises patient care. Overutilization exposes vulnerable patients to unnecessary, exhausting or potentially harmful procedures simply to satisfy corporate revenue targets. 

Three Takeaways from Medical Necessity Cases 

Much can be learned from the themes of these allegations, even if your organization isn’t an SNF or doesn’t provide therapy services. Medical necessity requirements are common across most healthcare organizations. 

Key lessons from this case include: 

1. Decisions about billing for medical care provided need to be based on clinical and regulatory requirements, especially coverage requirements from Medicare and Medicaid, for example.   Such requirements often include statutes about: 

• Medicare coverage 
• Medicare manuals 
• National Coverage Determinations  
• Regional Medicare Administrative Contractors’ Local Coverage Determinations (LCD)  

2. Regular, focused compliance coding and billing audits may identify aberrant practices. This is especially true for services whose corresponding medical documentation doesn’t support compliance with coding or billing rules.   
    
   For example, Medicare reimbursement rules state that routine, non-skilled services aren’t separately reimbursable. In this case, it was alleged that one therapy assistant was coached to include in therapy minutes the time it took him to arrive at a patient’s room starting with the moment he left the therapy department. 
    

3. Use data analytics to identify outliers. Most whistleblower cases alleging medically unnecessary services are brought by an individual with knowledge from inside the organization. Many times, the individual is a physician, nurse or other clinician with medical expertise.   
    
   This case was different. It was filed by a private analytics firm using publicly available data. Though rare, these cases do exist. If a private firm using public data could find the alleged aberrations, one would hope the organization’s own compliance professionals would be able to find similar aberrations if given the resources to look.  Additionally, the government is using data analytics to identify cases they want to pursue as well. 

Apply These Takeaways to Your Own Regulatory Compliance Program 

False Claims Act allegations alleging a lack of medical necessity can take many forms. The kind of service or type of provider may also vary, but these key themes appear in many cases. The astute compliance professional will learn from them and apply the principles to the operations and services provided at their own healthcare organization. 

The claims resolved by the settlement are allegations only, and there has been no determination of liability. 

The post Lessons from the Frontlines: A Case Study in Medical Necessity Enforcement  first appeared on YouCompli.

Compliance risks associated with medical necessity happen when providers fail to show clinical evidence that a service is essential for a patient’s health. This often leads to legal, financial and operational consequences. 

This article uses a specific example to explore the implications of medical necessity for healthcare systems. 

Recent False Claims Act Complaint Hinges on Medical Necessity  

Recently we wrote an introductory article discussing in general terms the compliance risks associated with medical necessity. That was first in a series on medical necessity. Now this article introduces a specific example.   

In this case, the U.S Department of Justice (DOJ) filed a False Claims Act complaint against a hospital group and three long-term care hospitals. They allege the False Claims Act was violated because some of the care provided (for which the hospital was reimbursed) wasn’t medically necessary. 

Three Ways Medical Necessity Impacts Performance 

Medical necessity remains a serious compliance risk for providers, including hospitals and health systems. It impacts these organizations in several significant ways: 

• Performance and Efficiency 
• Financial and Compliance Risk 
• Patient Outcomes and Quality 

1. Performance and Efficiency 

Administrative Burden: Research shows that “medical necessity” serves as a primary tool for allocating resources, but varying definitions across payers create administrative churn. Studies indicate that managing these requirements increases the revenue cycle workload, leading to delayed payments and reduced efficiency. 

Operational Streamlining: Conversely, some evidence suggests that when medical necessity is effectively operationalized (e.g., integrated into EHRs), it can increase the speed of diagnosis by eliminating redundant or non-essential tests.  

2. Financial and Compliance Risk 

Denial Management: A major area of study involves “medical necessity” as a driver of claim denials. Research by organizations like AAPC indicates that failure to validate medical necessity can lead to revenue loss, recoupments, and payer audits. 

Regulatory Exposure: Inadequate documentation of medical necessity is a leading cause of False Claims Act allegations, representing a high-stakes legal and compliance risk for health systems.  

3. Patient Outcomes and Quality 

Care Appropriateness: Studies suggest that medical necessity standards help align clinical care with evidence-based guidelines, which can improve patient safety by reducing exposure to unnecessary, potentially harmful procedures. 

Equity and Access: Research into determinants of health system performance warns that restrictive criteria can limit access to essential care for vulnerable populations if based on cost-containment instead of individual patient needs.  

Allege Longer Stays to Increase Medicare Reimbursement 

The example covered here reflects some of these negative impacts. In this False Claims case, the DOJ alleges that the hospitals held patients in the hospital longer than medically necessary in order to increase Medicare reimbursement.  

Long-term care hospitals (LTCHs) provide inpatient services for patients whose medically complex conditions require long hospital stays and programs of care. Medicare reimburses LTCHs based, in part, on a patient’s length of stay.   

By allegedly delaying discharge of certain patients, even when their course of treatment had been completed or when they could have been transferred to a lower level of care, the hospital received higher payments than they should have. 

The DOJ did not discover this issue on their own. The lawsuit was originally filed by a former employee of one of the hospitals through the qui tam or whistleblower provisions of the False Claims Act.  

How Internal Concerns Become Full-Blown Investigations 

Though allegations of medically unnecessary care may be a common reason such lawsuits are filed, understanding the details of a specific case is important.  

It can help compliance professionals see how concerns, potentially first reported internally, can develop into full blown investigations or additional complaints being filed with the court by the DOJ, as in this example. 

Manipulating Qualifying Patient Stays for Higher Reimbursement 

In the complaint, the DOJ alleges that the defendants illegally inflated their Medicare payments by holding patients who were ready for discharge until they reached a certain threshold date that, once reached, would trigger increased reimbursement.  

Certain Medicare patients who meet an average length of stay over the twenty-five days that LTCHs must maintain are referred to as a Qualifying Patient. The Government claimed the defendants also inappropriately held Qualifying Patients long enough to meet the 25-day average length of stay requirement to maintain their LTCH status and be paid at the higher LTCH rate.  

In the court document filed by the DOJ, it’s alleged that one executive told her employees, “No one is leaving early. We lose money.” Unfortunately, this wasn’t the only example of their alleged poorly handled medical necessity determinations. 

Ignored Alternatives Could Have Been Fraction of the Cost 

According to the complaint, many of these patients could have been discharged earlier and received care at home or in a nursing facility for a fraction of the cost to Medicare.   

The complaint also states that when employees raised concerns about the practices to one of its executives, the executive dismissed them, noting they would make money even if Medicare denied some medically unnecessary claims.  

Compliance Responsible for Appropriate Processes 

Compliance programs should ensure that appropriate processes exist to confirm the appropriate clinical criteria are met when it comes to admission and discharge actions.  According to the government, LTCHs specifically must have a documented process that: 

“screens patients prior to admission for appropriateness of admission to a long-term care hospital, validates within 48 hours of admission that patients meet admission criteria for long-term care hospitals, regularly evaluates patients throughout their stay for continuation of care in a long-term care hospital, and assesses the available discharge options when patients no longer meet such continued stay criteria.” 

The government states that in 2017, CMS observed that LTCHs appeared to be improperly holding patients beyond the key time threshold to obtain the full payment, which resulted in potentially improper delays in patient discharges other than solely for medical reasons.  

As a result, in fiscal year 2018, CMS revised the payment methodology to reduce LTCHs’ financial incentive to delay patient discharges until after the threshold. 

Example of Inappropriate Intent to Maximize Revenue 

The DOJ’s complaint contains statements that appear to imply they have emails or other documentation that show the intent to delay discharge. For example, an executive allegedly emailed a broad group of staff to praise them for getting “patients discharged on their correct discharge day to maximize our revenue.”   

Reportedly, the same executive also developed a bonus plan for a case manager in 2018 that required her to discharge 90 percent of patients on the “ideal discharge date” to receive a bonus. The ideal discharge date was a date calculated in a way (and reported on a dashboard) to lengthen the stay to meet higher reimbursement goals. 

Of course, the claims asserted in the complaint filed by the DOJ are allegations only.  However, most of the time the DOJ is not going to file a complaint if they do not believe they have or will obtain the evidence they need to either pursue the case further in court or lead to a mutually agreed upon financial settlement. 

Requirements for Medical Necessity Determinations 

Medical necessity determinations tend to be circumstance-specific. Auditing and monitoring for medical necessity will also typically require the involvement of a professional with clinical training or background.   

At times, it may be appropriate (if there are no conflicts of interest) to have a medical director from the organization be involved in such determinations. At other times, it may be a better idea to seek independent expertise from someone outside your organization. 

Learn from Examples of Medical Necessity Problems 

Watch for the next article in this series when we take another deep dive into an example of medical necessity in healthcare. In the meantime, browse these curated selections. 

Find More Advice and Ideas in These Related Articles 

• Introductory Article: Understanding Medical Necessity Compliance Risks The first post in this series, covering the foundational definitions and general compliance risks healthcare providers face today. 
• The False Claims Act: A Guide for Healthcare Leaders A deeper look into how inadequate documentation can trigger False Claims Act allegations and the resulting legal stakes for health systems. 
• Strategies for Reducing Claim Denials and Revenue Loss Practical insights into how medical necessity acts as a driver for claim denials and how to improve your revenue cycle workload. 
• Aligning Clinical Care with Evidence-Based Guidelines Learn how to leverage medical necessity standards to improve patient safety and ensure care appropriateness across your organization. 

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 When Compliance Risk Is Driven by Medical Necessity Problems  first appeared on YouCompli.

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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Qualified compliance professionals do the heavy lifting for you, simplifying regulatory change management  

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.

For healthcare compliance leaders, financial literacy is not optional. Compliance risk often hides in the fine print of financial data, making literacy a prerequisite for effective oversight.  

To identify anomalies or potential regulatory “red flags,” compliance officers must move beyond a high-level view of healthcare finance and understand how clinical operations translate into financial entries. 

What does a compliance leader need to understand? Things like: 

• Budgeting and capital planning 
• Internal controls and risk 
• Grant and research compliance  
• Key performance indicators (KPIs) 
• Communication between CFO and compliance officer 

Familiarity with the 14 steps of the revenue cycle is also valuable for mitigating risks associated with reimbursements and 340B compliance. (This topic is covered later in the blog.) 

Where Do Healthcare Compliance and Finance Intersect? 

Regulatory compliance and healthcare finance overlap in multiple ways. Compliance-related areas with a financial angle include: 

• Medicare, Medicaid reimbursement 
• 340B drug pricing 
• Stark Law and anti-kickback statutes 
• Charity care 
• Financial assistance requirements  

What Should Compliance Leaders Understand About Financial Statements? 

To build fiscal literacy, let’s start with some foundational concepts – financial statements. Compliance officers should have a basic understanding of these types of statements: 

1. Balance Sheet 
2. Income Statement 
3. Cash Flow Statement 

1. The Balance Sheet: Assessing Financial Integrity Through a “Snapshot” 

The balance sheet provides a snapshot of an organization’s financial health at a specific point in time, detailing its assets, liabilities and equity. 

Why Compliance Should Care: Monitoring the balance sheet helps ensure that assets are properly recorded, and that liabilities like these are appropriately disclosed: 

• Potential legal settlements 
• Debt obligations 
• Medicare overpayments 

2. The Income Statement: Monitoring Operational Risk Over Time 

Unlike the balance sheet snapshot, the income statement tracks revenue and expenses over a specific period, such as a month or a fiscal year. The income statement puts a focus on total revenue and expenses, and the difference between them, while distinguishing between operating and non-operating items. Those two concepts are compared in the chart below. 

In an income statement, it’s important to distinguish between accrual-basis accounting (matching revenue to period it was earned) and cash-basis accounting (recording transactions only when money changes hands). 

Why Compliance Should Care: By comparing current monthly performance against previous years, compliance officers can spot outliers in revenue or sudden spikes in expenses that could indicate billing errors, “upcoding,” or improper financial arrangements under the Stark Law. 

3. The Cash Flow Statement: Ensuring Operational Sustainability 

The cash flow statement tracks the actual movement of cash into and out of the organization, categorized by: 

• Operating activities 
• Investing activities 
• Financing activities 

Why Compliance Should Care: Understanding cash flow is vital for making sure the organization has liquidity to maintain compliance standards even during times of financial strain. A significant discrepancy between reported net income and actual cash flow can signal deep-seated issues with revenue cycle integrity.  

Revenue Cycle as Regulatory Roadmap 

For a prepared healthcare compliance leader, the revenue cycle isn’t just a financial process; it’s a regulatory roadmap. From initial patient interaction to final collection, each step presents a unique set of compliance risks that can lead to audits, fines or loss of reimbursement if not managed with understanding. 

What Compliance “Trapdoors” to Watch for in the Revenue Cycle 

The revenue cycle is full of complexity, largely fueled by the impact of different hospital types (PPS, critical access, disproportionate share, and tribal hospitals) on Medicare and Medicaid rates. 

While the full revenue cycle has 14 distinct stages, compliance officers should pay particular attention to these “trapdoors” where financial operations must meet strict federal regulations: 

• Front-End Integrity (Scheduling and Registration): Accuracy is paramount to ensure Medicare and Medicaid reimbursements aren’t jeopardized by incorrect patient data or lack of prior authorization. 
• Clinical Documentation and Coding: This is a high-density risk area. Compliance must make sure that coding reflects the actual services provided to avoid allegations of “upcoding” or “unbundling,” which can trigger False Claims Act investigations. 
• 340B Drug Pricing Program: If an organization participates in 340B, the revenue cycle needs rigorous internal audits to establish compliance with drug diversion and duplicate discount prohibitions. The stakes will be even higher if the program undergoes potential changes regarding payment models. 
• Billing and Claims Submission: Errors in this stage directly impact the Clean Claim Rate. More importantly, consistent billing errors for federal healthcare programs can lead to significant liability under Anti-Kickback Statutes or the Stark Law if improper financial relationships are found. 

Monitoring Denial Management at Back End of Revenue Cycle 

A robust compliance program monitors the back end of the revenue cycle as closely as the front. Analyzing denials can reveal systemic issues in documentation or billing practices that, if left unaddressed, represent both financial loss and compliance vulnerability. 

What KPIs Should Compliance Watch as Part of Financial Oversight? 

For a healthcare compliance officer, financial data is more than just a reporting requirement. It’s a proactive tool for risk assessment. By monitoring specific KPIs, compliance teams can move from reactive auditing to strategic oversight and identify operational stressors before they escalate into violations. 

The “Big Four” Financial KPIs for Compliance Officers 

Comprehensive financial oversight should track these four metrics: 

• Operating Margin: This measures whether the organization’s core clinical mission is profitable after all operating and overhead costs are paid. A shrinking margin often leads to “cutting corners” in staffing or documentation, which directly increases compliance risk. 
• Days Cash on Hand: This indicates liquidity. How many days can an organization operate using its current cash reserves if all revenue stopped? Higher liquidity provides the financial “breathing room” to maintain compliance and quality standards even during economic downturns. 
• Clean Claim Rate (CCR): A high CCR (ideally 95% or higher) indicates that claims are being submitted without errors the first time. A low rate is a red flag for systemic billing or documentation errors that could trigger federal audits under the False Claims Act. 
• Payer Mix: It’s critical to understand the percentage of revenue coming from Medicare, Medicaid and private insurance. In many healthcare models, Medicare functions as a “break-even” payer, while Medicaid reimbursements often fall below the actual cost of care, placing additional pressure on revenue integrity. 

What to Know about Budgeting and Internal Controls 

Compliance officers should also distinguish between the Operating Budget (daily/annual clinical operations) and the Capital Budget (typically reserved for long-term investments or items over $10,000). 

To prevent fraud and ensure financial integrity, a compliance program must enforce strict segregation of duties. This assures that no single individual has control over all aspects of a financial transaction, serving as a primary defense against embezzlement and improper financial reporting. 

Using the SBAR Tool to Structure CFO and Compliance Communication 

The most effective healthcare compliance programs are those where the Chief Compliance Officer (CCO) and Chief Financial Officer (CFO) operate as strategic partners.  

However, communicating complex compliance risks in a way that aligns with financial priorities requires a structured approach. This is where the SBAR tool (Situation, Background, Assessment, Recommendation) becomes invaluable for justifying financial decisions and resource allocation. (Download a helpful SBAR template at the end of this article)

Four-Step Method for Financial Advocacy 

Use this four-step method to present compliance needs to your finance team: 

• Situation: Clearly state the immediate financial or regulatory issue.  
  Example: “We have identified a 15% discrepancy in our 340B drug pricing audits.” 

• Background: Provide the necessary context and data.  
  Example: Current Medicare reimbursement rates for these drugs are subject to strict transparency requirements. 
   
• Assessment: Offer your professional analysis of the risk.  
  Example: Failure to rectify this documentation gap poses a significant risk to operating margin and regulatory standing and could trigger a federal audit. 
   
• Recommendation: Propose a specific, data-backed solution.  
  Example: “I recommend an immediate investment in automated tracking software as part of the next capital budget cycle.” 

How Compliance Can Secure a “Seat at the Table” 

By confidently speaking the language of finance with terms like liquidity, capital planning and debt financing, compliance officers move beyond being seen as a “cost center” and the “Department of No.”  

Instead, compliance can become a guardian of the organization’s financial sustainability, ensuring that compliance is integrated into every high-level discussion, from annual budgeting to long-term strategic growth.  

Ready to drive more compliance value? Reach out to see how YouCompli can help.  

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The post Financial Literacy: The “Superpower” Every Modern Compliance Leader Needs  first appeared on YouCompli.

In this blog, learn how to go on offense following a regulatory compliance audit or inspection, so you’re well-prepared for the next one. Using sports training analogies, the authors present a better way to handle ongoing inspections and audits in healthcare systems.  

If you play us in basketball, we’re going to run the fast-break transition offense at you, and we will tell you right now; you don’t want to play us two on two. We know our biggest strength – namely that conditioning kills. Savage speed plus unlimited endurance equals an unstoppable force.  

The fast-break transition offense we use is inspired by the 1990 UNLV Running Rebels basketball team. This high-tempo strategy aims to score before the defense can get set. It involves pushing the ball down the court immediately after gaining possession and creating scoring opportunities through numerical advantages and defensive mismatches.  

You can apply the same strategies when managing audits and inspections.  

What Drives Healthcare Audits and Inspections? 

Audits and inspections are regular occurrences in healthcare systems. A number of factors influence how often and what kind. 

• Internal vs. External: Healthcare organizations conduct their own internal audits monthly, quarterly or annually. 
• Regulatory Bodies: Government agencies conduct their own audits, with the number depending on things like budget and staff. 
• Risk and Regulation: Frequency may increase if issues are discovered or when major changes are made to regulations. 
• Organization Size: Larger organizations often have more complex auditing needs, potentially driving more frequent audits. 
• Staff Turnover: High turnover can trigger more frequent audits to ensure consistency. 

What’s Your Playbook for Regulatory Inspections and Audits? 

Most healthcare systems have good reason to believe that a regulatory inspection, sponsor audit or other scrutiny could appear at any time, announced or unannounced. It’s accepted that the standard technique for managing these visits is ongoing vigilance.  

At her presentation on “How to Be Your Own Internal Monitor: A Guide to Monitoring Your Own Studies” at the ACRP 2025 conference, Ann-Marie Jacobson, CCRP, Senior Research Affairs Specialist at Tufts University School of Dental Medicine, said “Because of the unknowns about inspections and audits of in-progress or completed clinical trials, it is important to make sure that all study materials are always kept accurate, current, and explanative of the study activities to date.”

“You always need to be asking yourself, if the Food and Drug Administration (FDA), sponsor, or IRB came in right now and selected a current or recently closed study for examination, would everything be ready?”  

She explained that at her institution, study coordinators “regularly conduct audits of regulatory binders, subject folders, case report forms (CRFs), payment logs, and enrollment/screening logs. These are coordinators who are separate from the clinical team, to ensure that fresh perspectives are always present.” 

We don’t disagree with her, but we wouldn’t call that a fresh approach. Rather, we think that ongoing vigilance should be the standard in healthcare compliance, like a basketball team needs the fundamentals of solid shooting, dribbling and passing.  

Changing Audit Landscape Requires a New Game Plan 

The current healthcare audit landscape is shifting and shifting quickly. Back in late 2024 and even earlier this year, federal and state auditors would arrive and investigate one complaint at a time. They’d come in specifically for one reason or to investigate a particular incident, talk with a couple of staff members, and then summarize their findings and leave.  

Now, we’re hearing differently. Just this week at one of our collegial facilities, an investigator came in to investigate about 10 complaints in various areas, from documentation, to patient care and the like.  

To diligently investigate complaints of this type and volume, the auditor or inspector is probably going to be there on-site for a week or more. They will gobble up valuable conference room space, staff time and basically throw your whole operation into a tizzy due to the heightened emotional state.  

What’s your game plan for audit readiness now? 

Fast Break Offense for Compliance Audit Readiness 

How do you combat this? Well, if you use the key principles of a fast break offense, you will be prepared and conditioned. We’ve adapted these three techniques to the compliance game, to make champions of your team. 

1 – Push the Pace 

In basketball, coaches encourage players to maintain a fast pace and recognize when to initiate the first trigger. In an audit, this means anticipating what the auditor is going to ask and getting ahead of it before they bring it up.  

Pre-audit prep meetings and ongoing reviews of your events make this work, but you can’t just do a pre-audit meeting when an inspection is scheduled. You need to regularly schedule pre-audit meetings, so you’re always prepared.  

I know most organizations don’t do this. But we do. Which is why we have covered things so thoroughly that we can go quickly and get the auditor what they need and then move on to the next question.  

2 – Strength in Numbers 

In sports, we recognize numerical advantages, such as 2-on-1’s, 3-on-2’s or 4-on-3’s and then capitalize on these circumstances through drive-and-kick sequences. Drive the ball to the basket and when the defense collapses on the person with the ball, you kick the ball out to an open teammate to hit a jump shot.  

Within audits, scoring means answering auditors’ questions with the best players you have. You create a numerical advantage by bringing in multiple people to meet with the auditor at the same time and kicking facts around like you would move the ball to score.  

3 – Continuously Practice Good Habits Across the Team 

Lastly, you need elite conditioning habits in sports and in compliance. To run the fast break effectively, you can’t get tired. Imagine unleashing an endless barrage of offense and staying so diligent to this effort that teams know it’s coming and still can’t stop it.  

The team with the most dialed-in offense is usually the most capable, but you need to have players who can react “lag-free” or win their first three steps to capitalize on numerical advantage. The only way to get good at this is to continually work on it.  

Quality and compliance preach continuous improvement, but how often do you do make the effort? How often do you stay late at work, just because? How often do you run more meetings or make everything tighter?  

Chances are zero times, but I will tell you right now that we do. So, if you get into an audit with me, by Day 4, I am still working with a full gas tank, but the auditor isn’t because they went home and “Netflixed“ while I slept. Get your whole team committed to elite habits, and you are unstoppable.  

Prepare Your Compliance Program for the Win 

By reinforcing these principles and working on conditioning and decision making, teams can create more scoring opportunities. And just as a prepared team can force the defense into difficult situations, a well-prepared compliance team can “force” the auditor into zero-findings and more quality inspections.  

Download a PDF Version of the Tip Sheet

Create Compliance Scoring Opportunities 

If you’re interested in more ideas for building a strong compliance program, read these resources next. A strong compliance culture is the foundation of a strong program. 

10 Tips for Building a Compliance Culture in Healthcare 

Earning recognition as a value creator and establishing a healthy culture can be challenging. Yet as these 10 tips show, you can successfully shape culture to help the larger organization better manage and control risk. 

Healthcare Compliance Culture Means Doing the Right Thing at All Levels 

A culture of compliance isn’t just a platitude. It really does exist. Those organizations with a strong culture of compliance and an effective compliance program are the ones with engaged clinical and operational leaders. 

A Culture of Compliance Through Proactive Decision-making 

A culture of compliance is critical to effective regulatory change management. Find three steps to help your leaders make decisions more proactively.   

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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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.

Visit Now

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The post With Compliance Audits, The Best Defense is a Good Offense  first appeared on YouCompli.

In every organization there is a moment where the quality department becomes either the trusted operational partner or the operational roadblock. The difference tween the two comes from how you communicate, assign responsibility and how you follow through. This blog explains how to adopt the OG style for more effective quality programs in healthcare. 

Comparing Two Styles of Quality Performance 

There are two guys – let’s call them Young Buck and OG. The Young Buck is probably 30, limitless energy, the one-man wrecking machine. You know that guy. Full of passion or some other nonsense. All gas and no brakes. Runs through the facility on a crusade to save the world. All alone. Takes on all the tasks but somehow, really accomplishes nothing except annoying everyone else on the team with his constant question of “Need anything?” 

OG is a bit different. Older. Works like he is 30 with the wisdom that comes from being 20 years older. Shaved head, salt-and-pepper beard. Dresses as he wants because he has the street cred and knowledge to back it up, so no one cares. Works as an individual contributor but has a connection to everyone on the leadership team. Can tell you about all their strengths. Kills every audit, understands the entire operation. Has paid his dues, knows who he is and does not chase anyone’s validation except his own. 

Operational Partner or Quality Roadblock? 

The OG knows a thing or two about operational improvements that matter. He goes beyond simple efficiency improvements such as how units are staffed or cost-cutting initiatives like slashing overtime because the team is over hours.  

The OG embraces the philosophy that all aspects of the organization work harmoniously to deliver maximum value to customers, while minimizing waste and variation in processes (Six Sigma, 2025). It’s simple execution like this, isn’t it?  

• The organization develops systems that promote problem-solving at all levels. 
• Best practices are the norm not the exception  
• Cultivate culture where improvement is habitual, not exceptional.  
• Discipline and consistency are staples that override passion and enthusiasm. 

The operational roadblock is not always the guy who says no, at least not in this scenario. What we are describing is far too common. This roadblock doesn’t know what he doesn’t know and is too focused on short-term results (his own) than on long-term gains (the team’s). He’s in favor of acting but instead of evolving his processes thoughtfully, he wants to make significant changes to the way an organization operates. What this does is create bottlenecks, upset the status quo and build employee resistance. 

OG or bottleneck? Take your choice:  

• Long-term investment or short-term expense?  
• Streamlined processes or maximized rework? 
• Improved quality control or weakened inventory management?  

Us, too. The difference is how you communicate, how you assign responsibility and how you follow through. 

Three Ways to Partner like a Pro 

Want to be more like the OG? Here are some tips for more effective quality operations: 

1 – Communication: Be clear. Be direct. Know what you want to say before you actually say it. Think it out and then say it. Don’t be monologuing at people like Carson on The Tonight Show. You don’t need people to necessarily like you. It helps but it helps more if they respect you. The only way to get that is to tell them what needs to be said, say it and then follow up when needed. 

2 – Responsibility: Assign tasks to people for things they can be responsible for and actually succeed in. Read that again. It is selected delegation. Holding people responsible for things that they cannot perform is a recipe for disaster. In cliched terms, hold your people accountable. 

3 – Follow Through: So simple it only takes one sentence. Do what you say you are going to do, how you said you’d do it, when you said, over and over again. Period. That’s it. All you need to do. 

OG Your Way to Effective Quality and Compliance 

You don’t need to “young buck” your way through quality and compliance. The only way to be the OG is to become respected, highly regarded, skilled and authentic in what you do. Your team and organization will thank you. 

Ready to Learn More? 

We’ve got more resources on quality and compliance in healthcare. Have a look at these three selections: 

White Paper: How Compliance Drives Healthcare Quality and Safety 

Effective compliance management directly supports quality care, operational efficiency, and financial stability. Read the white paper for practical ways to leverage compliance as a strategic asset, transforming regulatory obligations into opportunities for excellence in patient care and organizational success. 

Blog: Four Ways to Integrate Compliance with Safety/Quality Efforts 

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. 

Blog: Building a Quality Education Program That’s Good Enough 

It’s essential that you build a quality education program that works. Doing that right means covering the basics well, not adding fancy bells and whistles. This blog explains what will lead to training sustainability for you and the organization.   

Download Tip Sheet Below

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
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• Navigating Compliance Responsibility: A Foundation… by Amy Laufmann, MBA

The post Healthcare Quality Leadership: How to Be an Operational Partner, Not a Roadblock first appeared on YouCompli.

On a daily basis, compliance officers are asked to find solutions to a variety of operational requirements. For example, consider a regulatory change requiring the organization to adjust an operational process in order to bill for a particular service. In this case, the solution must be compliant and operational-friendly, but who’s responsible for making that happen? 

While supporting operations in finding compliant solutions is part of our role, becoming the de facto fixer of what constitutes “operationally friendly” is beyond our scope. That piece must be owned by operations.  

The challenge then becomes how to get operational leaders to take ownership for resolving their own compliance challenges. 

Five Strategies to Help Operational Leaders Take Responsibility 

These five strategies will help your operational leaders take responsibility for their particular compliance issues, while preserving your role as a trusted advisor. 

#1 Use a “Coach” Mindset, Not a “Gotcha” One 

If you want your leaders to take more ownership of their own compliance challenges, then position yourself as a coach who helps them think through problems and find solutions—not as a person who catches mistakes. 

To pull this off, you need to be intentional about the types of questions you ask. More specifically, you want to ask curiosity-based questions, not judgmental ones. Here are some examples of guiding questions you can ask as you’re helping them find a solution:  

• What challenges are you facing right now? 
• Is there a part of this new regulatory change that feels uncertain to you? 
• What steps do you think you need to take to address this issue? 
• What’s one small step you could take today to move forward? 
• What options or solutions have you considered? 

Know When to Step In and When Not To 

Having a coach mindset also means knowing when to step in—and when not to. For example, your role is to escalate compliance risk when appropriate (e.g. a deadline looks like it’s going to get missed), but it’s not to do the operational work for them (e.g., following up with a subject matter expert for their input).  

If a leader doesn’t take action despite your support, then resist the urge to fix it yourself. Instead, document it and elevate appropriately within your organizational structure to bring about resolution. 

Having a coach mindset encourages operational leaders to own their compliance challenges because when leaders feel heard and supported, they’re more motivated and invested in their work to find a solution. Also, by supporting those closest to the work in addressing issues, it leads to more practical (and often) faster solutions. 

#2 Frame Risk as Operational Risk, Not a Compliance Burden 

In my experience, operational leaders are more likely to engage when compliance is framed in business terms and not compliance jargon. For example, instead of reading or citing regulations, explain the operational impact of the requirement to them. Talk about things like billing delays, lost revenue, patient safety, or reputational damage.  

Additional topics to consider when framing risk as operational risk include: 

• Patient care 
• Staffing 
• Operational costs 
• Budget variances 
• Workflow 

Framing risk as operational and not as a compliance burden helps promote ownership in solving compliance challenges for a couple of reasons. First, this approach speaks their language. When you frame risk in terms that operations understand, they’re more likely to grasp the urgency and relevance of the ask.  

Second, it makes the problem theirs—not yours. If the risk is shown to impact their budget, performance metrics, or reputation, they’re more likely to feel responsible for addressing it.  

Finally, presenting risk in this way increases engagement and accountability. When compliance risks are reframed as disruptions to their performance goals—employees naturally step into problem-solving mode and take accountability.   

 
#3 Stay Curious, Not Critical 

In my experience, the most effective way to approach communications with operational leaders when it comes to compliance is one rooted in a curious mindset, not a judgmental one.  

For example, let’s assume a leader did not follow through on something they said they would do. A judgmental way to respond would be: “You said you would do this, but clearly that meant nothing.” On the other hand, if you said, “Tell me what challenges you’re facing in moving this forward?” that comes across less adversarial, and more likely to produce a collaborative discussion.   

To help compare and contrast the two approaches, consider these additional examples: 

Taking a curiosity-based approach helps support leaders in solving their own compliance challenges because it builds psychological safety by inviting open dialogue and new perspectives. In my experience, operational leaders are more likely to think creatively when they don’t feel scrutinized.  

#4 Make It Easy for Leaders to Act 

Like compliance officers, operational leaders face constant pressure, decision fatigue, and competing priorities—all of which leads to cognitive overload. Relatedly, if the problem-solving process feels overly complex or burdensome, leaders are likely to disengage or defer responsibility.  

To that end, making compliance easier for your leaders doesn’t mean dumbing it down—it means removing friction. (YouCompli Software is designed for this.) 

When you need support, free up mental bandwidth demands by simplifying the work. Clearly communicating expectations or removing unnecessary steps frees up their mental bandwidth. In my experience, when leaders feel less overwhelmed, they are more likely to engage with issues and take initiative.  

So how can you make the work easier for them? Here are some examples that may help: 

• Explain compliance language in terms they can understand. 
• Take the initiative to set up and facilitate root cause analysis discussions. 
• Coordinate and facilitate stakeholder calls to discuss solutions. 
• If they’re feeling stuck, suggest a series of smaller goals to achieve the work. 
• Provide templates, decision trees, checklists, or other tools to make compliance easier. 
• Offer potential solutions (but as pointed out above, don’t take on the work involved.) 

Making the work easier for your operational leaders encourages them to solve their own compliance challenges because it makes the process more approachable and less threatening. That, in turn, increases their willingness to participate and take ownership. When leaders feel less overwhelmed, they are more likely to engage with issues and take initiative.  

#5 Recognize and Reward Ownership 

Finally, another way to foster operational ownership is to call out your leaders (publicly or privately)—in a good way of course—when they take the initiative to solve their own compliance issues.  

For example, let’s assume an audit was conducted in a clinical department related to medical necessity documentation. As part of a corrective action plan, monitoring is needed to ensure the documentation is in the patient’s medical record. If the department director proactively develops a tool for monitoring and vets it with you, then in response, you might say:  

“I really appreciate how you took ownership to proactively develop this tool. That kind of initiative supports us in maintaining a strong culture of compliance in the organization.” 

If leaders only get attention when their problems are escalated to you, they learn to seek approval through dependence. Recognizing effective problem-solving flips the script. It signals that ownership and resolution—not escalation—are what gets rewarded. 

Here are some ways you can recognize and reward your leaders:  

• An unexpected handwritten thank you note directly to the leader, or better yet, the leader’s supervisor  
• One-on-one verbal recognition 
• A note sent from the Chief Compliance Officer (if that’s not you) to the leader 
• Public recognition in a department or team meeting 
• Nomination for a leadership award 
• Feature in a compliance or organizational newsletter 

Recognizing and rewarding great work is helpful for motivating leaders to solve their own compliance challenges. It creates a positive feedback loop where those behaviors become self-reinforcing and then contagious to others on the team. 

Compliance work is complex, and compliance work requires human interaction. That is especially true when it comes to getting your operational leaders to find solutions to their own compliance challenges.  

By following the strategies outlined above, you empower operational leaders to manage their own compliance risks. Just keep in mind that it is a process that takes time, but in the long run, an empowering leadership style will improve buy-in to your program and create a more cohesive culture of compliance.

Download a free PDF Tip Sheet Version of this blog below.

Jay is a compliance professional and consultant in Colorado. He is a healthcare lawyer with significant industry knowledge of the U.S. healthcare market. Over the past 20 years, he has worked for large for-profit and non-profit health systems and small physician-owned entities. In tackling the countless regulatory and operational issues for these diverse organization types, he has developed a deep understanding of the business of healthcare and the regulations governing the industry. 

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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.

Visit Now

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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 5 Strategies for Compliance Accountability Across the Organization  first appeared on YouCompli.

Aligning healthcare regulatory compliance with revenue cycle management is critical to mitigating risks and preserving business integrity. This blog explores three effective strategies to foster collaboration between compliance teams and revenue cycle management.  

Some of the most significant compliance risks faced by healthcare organizations today are found in the revenue cycle. The HHS OIG has stated, “One of the best ways to identify fraud and abuse risks is to follow the money.” 

For many healthcare organizations, this means having a good working relationship with the entity’s revenue cycle team.  

The revenue cycle is the process that starts with a patient’s initial appointment and ends with full payment for services. It encompasses all the administrative and clinical functions that contribute to collecting patient service revenue.  For healthcare organizations that provide services to patients, the revenue cycle is the organization’s financial lifeblood. 

3 Ways Compliance Can Stay Connected with RCM 

If compliance has a good working relationship with revenue cycle management, the two functions can enjoy a fruitful outcome.  

Compliance professionals should consider the following three ways to interact with the revenue cycle team. 

1. Regular Collaboration 

We know from OIG guidance documents that, to be effective, the compliance officer should maintain a degree of separation from the entity’s delivery of healthcare items, services, and related operations.  

Even though this means the compliance officer should not be responsible, either directly or indirectly, for the delivery of healthcare items and services or billing, coding, or claim submission, it does not mean the compliance officer should not be well-versed in these functions through regular communication and collaboration. 

Take Advantage of Compliance Committee Connections 

Regularly collaborating with the revenue cycle team will inform compliance professionals of the specific risks and potential compliance red flags the revenue cycle may be facing.  Many organizations ensure this collaboration by having revenue cycle leadership serve on the organization’s compliance committee.  

In fact, the OIG states the compliance committee “…should be comprised of the relevant leaders of both operational and supporting departments, which could include Billing and Coding, Clinical and Medical, Finance, Internal Audit, IT, HIM, Human Resources, Legal, Quality, Risk Management, Sales and Marketing, and other operational managers.”  Most of the departments suggested by the OIG play a role in the revenue cycle. 

In addition to revenue cycle personnel participating in the compliance committee, collaboration between compliance and revenue cycle can occur on a weekly basis through meetings and sharing of revenue cycle data such as denial rates, reports from electronic claims editors, communications from third party payors and any internal coding and billing monitoring the revenue cycle is performing. 

2. Proactive Claims Auditing  

The OIG tells healthcare providers that they “…should take proactive measures to ensure compliance with program rules, including regular reviews to keep billing and coding practices up to date as well as regular internal billing and coding audits.” 

In organizations that submit claims for services, a sizable number of resources should be dedicated to ensuring the claims they are submitting for reimbursement meet all program requirements.  

The revenue cycle team should have monitoring efforts in place for correct coding and billing.  Also, compliance departments should ensure that independent claims audits are also occurring regularly. 

Assisting Revenue with 60-Day Repayment Rule Requirements  

Even if an entity makes innocent billing mistakes, they have an obligation to repay the money to government third-party payers such as Medicare and Medicaid. The Affordable Care Act included a requirement that entities must report and repay overpayments by the later of: “(A) the date which is 60 days after the date on which the overpayment was identified; or (B) the date any corresponding cost report is due, if applicable.”  Sometimes this is referred to as the 60-day repayment rule. 

If a revenue cycle team’s internal monitoring identifies overpayments, it is critical for compliance departments to know the date of discovery, so the organization does not run afoul of the 60-day repayment rule. If the entity does not monitor the repayment requirements, they could be subject to liability under the Federal False Claims Act. 

3. Training and Education Geared to Job Roles 

Coding and billing rules are regularly updated and can change frequently, and it’s often difficult for busy clinicians to stay on top of the changing regulations. Compliance and revenue cycle teams should work together to ensure those involved in revenue cycle functions are educated on the most current rules. 

The OIG recommends targeting training depending on an individual’s role. Thus, those involved in revenue cycle operations need to provide training and education specific to the nuances of the revenue cycle. The training sessions should cover any compliance risks specific to the learners’ roles and responsibilities.  

Depending on the learners’ roles, these may include: 

• Billing 
• Coding 
• Documentation 
• Medical necessity 
• Beneficiary inducements 
• Gifts 
• Interactions with physicians  
• Other sources or recipients of referrals of federal healthcare program business 

Three Ways to Show You Follow the Money

If healthcare organizations are going to address their biggest compliance risks, they must include the revenue cycle. Compliance professionals can lead in addressing revenue cycle risks by: 

• Driving effective collaboration between compliance and revenue cycle teams 
• Verifying that proper auditing and monitoring of claims are occurring  
• Ensuring those involved in revenue cycle receive targeted training based on their specific role.  

Doing these three things helps show your compliance program is indeed “following the money” as suggested by enforcement agencies such as the OIG. 

About Solutions for Compliance Management and Operations 

Need help keeping track of everything going on in regulatory management? When multiple people and departments are involved, the last thing stretched compliance teams need is more manual work.  

YouCompli compliance solutions keep cross-functional engagement organized, verified and on schedule.  

• Identify and assign specific individuals responsible for completing regulatory requirements. 
• Track progress and on-time completion of all regulatory requirements. 
• Verify that regulatory requirements have been acted upon within the organization. 
• Gauge and quantify potential areas of risk related to incomplete regulatory requirement assignments. 

Detailed reports equip compliance teams with oversight information they need to effectively communicate, act on, monitor, and focus organizational compliance efforts. 

Combine YouCompli solutions with the three best practices in this blog to build productive connections with Revenue and other departments.  

More Resources About Revenue Cycle Management and Compliance 

If you’re interested in learning more about the Revenue angle of healthcare compliance, here are a few additional resources: 

White Paper: Exploring the Four Hot Spots Of the Healthcare Revenue Cycle 

Case Study: Getting It Right: Minimizing Self-identified Overpayments & Maximizing Accurate Billing 

Tips and Tactics: Revenue Cycle Management Compliance: Ensuring Financial Health in Healthcare 

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.   

Download our Latest Whitepaper

Sign-up for our Weekly Newsletter

Qualified compliance professionals do the heavy lifting for you, simplifying regulatory change management  

---

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.

Visit Now

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The post Three Strategies to Align Compliance with Revenue Cycle  first appeared on YouCompli.