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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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.

It amazes us how many healthcare facilities don’t always store records appropriately. Check that. People don’t store records properly.  

Just this week, I was in a colleague’s office. Literally, it looked like Staples puked up aisle 3. I asked her what everything was, because you couldn’t make heads or tails of any of it. She explained that it was patient records that she didn’t know what to do with.  

I asked her, “Well, what does the process say to do?”  

“Process?” she said. Nice girl, means well, greener than a pepper tree.  

After helping her re-organize everything, I was motivated to put together some ideas to help others in her situation. Here are some record retention best practices in the event you have hoarded up some claptrap and now have to figure out what to do with it.  

What Records Do You Have? Archival or Data? 

First step, take an assessment of everything you have. Samples? Materials? Records?  

Archival storage should be for all original records, including source data and metadata, which are generated, recorded, calculated or transcribed at the time of an activity. This data allows full and complete reconstruction and evaluation of the activity.  

Data storage may be written, printed electronically, scanned image, photographic, or other form for later reference. Raw data obtained from measurement, testing, processing, direct observation or computer, and instrument printouts should be represented exactly as captured at its source without transformation, aggregation or calculation.  

Responsible Parties and Retention Periods 

All personnel should be responsible for handling, submitting or returning records to the archive in the same conditions in which they were found.  

Keep in mind that different items are governed by different regulations, so you need to check retention periods. The retention period begins when all work with samples or records is complete. Specified retention periods supersede any other retention requirements unless explicitly noted. 

Factors Influencing Retention Period Requirements 

• State and federal laws: State laws are the primary source for retention periods, which can range from three to over ten years. Federal laws, like those from CMS for Medicare, may also have specific requirements.  
• Patient age: Records for minors often require longer retention periods, usually extending past the age of majority.  
• Type of record: Different types of records can have different retention requirements. For instance, some states require longer retention for certain records like mammography images.  
• Legal and regulatory changes: Laws and regulations can change, so it’s important to stay updated on current requirements. 

Scope of Work in Healthcare Records Retention Process 

Generally, quality or project management takes the lead on records retention. The scope of work involves: 

• Archiving, filing, retaining, organizing and retrieving records 
• Maintaining security and integrity of records in archives if stored on-site 
• Collecting and cataloging records, including: 
• Assigning archival numbers 
• Preparing archive labels, updates to archival forms 
• Making copies of any supporting electronic data  
• Handling off-site storage as applicable.  

On-Site and Off-Site Record Storage Locations 

For healthcare records, you have two storage choices: on-site or off-site.  

If you store records on-site, storage must be access-controlled, and all records must be stored appropriately to ensure integrity and preservation, minimize deterioration and facilitate timely retrieval. All original paper records should be stored in secure, fireproof filing cabinets or appropriate containers, like folders, binders, weather-proof envelopes, cases or boxes. 

If you decide to store records off-site, make sure to use a qualified contractor specializing in off-site medical records storage. Quality should be involved in sending records off-site. All records should be assigned a unique number or other appropriate identifiers which your site must maintain.  

Records should be sent off-site appropriately grouped by record type. This is important because at some point, you might need to retrieve them. And you generally don’t have much notice to retrieve something. It’s generally an immediate need or within 24-48 hours, so if you don’t know where the records are or how they are organized, you won’t be able to produce them as you need to. That’s a problem.  

General Guidelines to Reduce Risk in Records Retention 

Healthcare record retention is governed by federal and state laws, requiring that records be kept for a specific period for patient access, legal protection, and compliance.  

Your organization should operate under the basic requirements for retaining records unless otherwise specified. Use these general guidelines to ensure your processes are set up for retention compliance: 

• Without a specified retention period, a minimum period of 10 years should be used.  
• Once the defined retention period is reached, samples and records may continue to be maintained, returned, transferred to the appropriate owner, or destroyed.  
• Do not destroy anything without appropriate approval from the functional owner.  
• Record destruction must be appropriately documented to denote the end of the life cycle. 

What’s Your Next Step? 

When you have these processes and practices in place, records retention will be a lot more efficient and a lot less stressful.  

Want more ideas for optimizing compliance and quality? You’ll find guidance in these popular articles. 

• Four Ways to Integrate Compliance with Safety/Quality Efforts 
• Best Practices for Better Training in Healthcare Compliance
• Integrate Self-Awareness into Healthcare Compliance Programs: 18 Tips  

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

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The post Hoarders Need Borders: Quality’s Role in Healthcare Record Storage  first appeared on YouCompli.

Many compliance professionals rely on HHS OIG focus areas as they perform risk assessments and plan subsequent auditing and monitoring activities. In November 2024, the OIG added an item to their Work Plan describing their intention to review Medicare Part B payments for skin substitutes.  

More recently, in September of 2025, the OIG published a data snapshot report that concluded Medicare Part B payment trends for skin substitutes raise major concerns about fraud, waste and abuse.  

This blog explores the implications for compliance and what health systems need to be aware of.  

How Skin Substitutes Are Covered Currently 

Skin substitutes aid in wound healing and redevelopment of skin. Medicare covers skin substitutes that are reasonable and necessary for the treatment of an enrollee’s condition. Local coverage determinations state that Medicare Part B generally covers skin substitutes for treatment of diabetic foot ulcers and venous leg ulcers that have failed to respond to at least four weeks of standard wound care.  

However, no national or local coverage requirements apply for other wound types (e.g., pressure ulcers or trauma wounds), and coverage of skin substitutes for these wounds is determined on a case-by-case basis.  

How Medicare Pays for Skin Substitutes 

Medicare Part B pays for skin substitutes based on the number of service units billed at prices ranging from approximately $100 to more than $1,000 per square centimeter.  

For payment purposes, CMS treats skin substitutes like approved prescription biologics, and skin substitutes are reimbursed in non-institutional Part B settings at 106% of the average sales price (ASP).  ASP Refers to the average price of a drug sold to providers, and it’s used for calculating reimbursement rates.  

From calendar years 2020 through 2023, Medicare Part B payments for skin substitutes increased substantially. In two years, Part B spending on skin substitutes increased 640%, going from $389 million (Q3 2022) to $2.88 billion (Q3 2024). 

What Drives Increases in Skin Substitute Pricing and Utilization? 

The rapid growth in expenditure is driven by both higher prices and increased utilization, and the OIG found concerning trends in both areas. 

Higher Prices Driven by ASP and Incentives 

Some of the factors potentially increasing prices include the ASP and incentives for providers. Manufacturers of skin substitutes can quickly bring new skin substitutes to market compared to typical products paid using ASP.  

By statute, ASP is defined as a manufacturer’s sales of a drug to all purchasers in the United States in a calendar quarter (net of most discounts) divided by the total number of units of the drug sold by the manufacturer in that same quarter. 

Calculating Payments for Billing Codes 

Manufacturers are required to report the ASPs and total sales volume for each of their Part B drugs to CMS within 30 days of the end of every quarter. CMS then uses this data to calculate a payment amount for the billing code representing the drug.  

Because different versions (i.e., dosage amounts, package sizes) of a drug may be included within the same billing code, CMS calculates an overall volume-weighted ASP for the code using the manufacturer-reported sales data. By statute, Part B payment is set at 106% of the volume-weighted ASP.  

In cases in which CMS is unable to calculate a volume-weighted ASP for a code (e.g., a new code for which ASPs have yet to be reported), Medicare Part B contractors typically use Wholesale Acquisition Costs, aka WACs (i.e., list prices) or payment invoices to determine a payment amount.  

Providers Seek More Favorable Payments Based on Spread 

Allowing for the time it takes for manufacturer price reporting and the subsequent CMS validation and calculations, there is a two-quarter lag in the ASP-payment process (e.g., first-quarter 2024 ASPs were used as the basis for third-quarter 2024 payment amounts). 

Part B providers can retain the “spread” between their acquisition cost for a drug and the Medicare payment amount. Previous OIG work found that higher spreads may correlate with increased utilization for certain drugs.  

Under the current payment system, Medicare often pays providers for skin substitutes at amounts much higher than providers’ purchase prices, and providers keep the “spread.” This creates incentives to bill for more and more units of skin substitutes and to choose products with the greatest spreads – the same types of billing trends highlighted in the OIG’s report. 

Increased Utilization Has Average Part B Payment Up 153% 

Utilization of skin substitutes has also increased steadily, with more enrollees having skin substitute claims and a higher number of units being billed per enrollee. OIG found that between the first quarter of 2023 and the third quarter of 2024: 

• Number of unique Part B enrollees with skin substitute claim increased by 53%. 
• Total number of units paid under Part B increased by 83%. 
• Average Part B payment amount for each unit of skin substitute increased by 153%. 

In less than two years, the amount paid per Part B enrollee has tripled from $40,051 to $121,501. 

28% Growth in Utilization and Payments in Home Care Settings 

The OIG also found the growth of skin substitute utilization and payments in the home care setting to be particularly notable. By the third quarter of 2024, 28% of enrollees with a paid skin substitute claim under Part B were reportedly being treated in their home. These home care enrollees accounted for more than half of Part B spending on skin substitutes that quarter. 

They also noted that utilization and expenditures for skin substitutes under Medicare Advantage (MA) are just a fraction of utilization and expenditures under original Medicare.   

For example, in the third quarter of 2024, OIG found that only 3,800 Medicare Advantage enrollees were associated with a skin substitute claim, compared to 24,000 enrollees in Part B.  

OIG concluded there were no obvious differences in the enrollee demographics of original Medicare and Medicare Advantage that would explain the massive variance in skin substitute utilization.  

Instead, they suggested variance is likely driven by MA plans’ ability to use numerous reimbursement and utilization management tools to set payment rates and coverage for products such as skin substitutes. 

Urgent Action Needed to Rein in Spending Increases and Fraud 

Based on their data snapshot report, the OIG concluded that action is urgently needed to rein in the massive increases in Medicare Part B spending for skin substitutes in non-institutional settings. They also cited numerous fraud schemes involving skin substitutes. 

Compliance professionals should make sure they are considering their organization’s use of skin substitutes and determine if there are existing risks. If so, they should monitor and audit their organization’s use of skin substitutes to ensure compliance. 

More Resources on Compliance Risk 

Know the Compliance Risk for Certain Anesthesia Services 

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.   

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. 

Exclusion Screening Failure Causes Compliance Nightmare 

Even a seemingly small glitch can have major consequences for healthcare compliance. This blog shares the story of the consequences of an incident when exclusion screening software glitched. 

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 OIG Cites Fraud, Waste and Abuse Concerns with Skin Substitutes  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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Qualified compliance professionals do the heavy lifting for you, simplifying regulatory change management  

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

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.

Peripheral vascular disease (PVD) reimbursement is fraught with potential compliance pitfalls. With increased scrutiny and worrisome statistics about improper payments, healthcare providers must identify and mitigate any PVD compliance risks that could jeopardize their operations.  

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.  

Equip yourself with the knowledge to navigate this complex environment and safeguard your organization’s reputation and financial sustainability. Learn effective strategies to mitigate compliance risks in peripheral vascular reimbursement by focusing on medical necessity and adherence to guidelines. 

What’s your compliance risk when it comes to reimbursement for specific medical procedures like peripheral vascular interventions (PVD)? 

Hospitals, health systems and medical practices providing peripheral vascular procedures should be aware of recent scrutiny of these services by government enforcement agencies. 

What Therapies Target Peripheral Vascular Disease? 

Peripheral vascular disease can result in the narrowing or blockage of arteries in the periphery, such as the lower extremities. There are many different therapies to address PVD, including the typical first-line treatment of lifestyle changes and medications.  Lifestyle changes include quitting smoking, eating a healthy diet low in saturated fats, regular exercise and weight management. Some PVD medications include the statin class of drugs, antiplatelet agents, ACE inhibitors and others.   

If lifestyle changes and medications don’t work, and certain clinical criteria are met, patients can undergo peripheral vascular procedures. These are minimally invasive procedures intended to improve blood flow through the arteries. Angioplasties, atherectomies and placement of stents are types of peripheral vascular procedures. 

OIG Looks at Compliance Risk in PVD Reimbursement  

Enforcement agencies are concerned with the increasing volume of these procedures. The problem relates to suspicions that some clinicians perform these procedures when they’re not medically necessary. 

The HHS OIG has added two different projects to their work plan related to peripheral vascular procedures. The first is “Utilization of Peripheral Vascular Procedures and CMS’s Related Program Integrity Efforts.” They report that in one calendar year, Medicare paid more than $600 million for atherectomies and angioplasties in peripheral arteries with and without a stent.   

Editor’s Note: The Work Plan is a guide to OIG priorities around oversight and compliance. By reviewing the Work Plan, health systems can identify potential compliance risks and proactively take action to mitigate them. 

Fraud Concerns Over Vascular Reimbursement Volume 

The OIG also states that both CMS and whistleblower fraud investigations have identified these surgeries as vulnerable to improper payments. This particular project is designed to determine trends in Medicare fee-for-service for surgeries in peripheral arteries over several years and identify paid claims that exhibit questionable characteristics.  

The OIG will also describe program integrity activities that CMS and its contractors have taken to combat fraud, waste and abuse specific to procedures in peripheral arteries. The report is expected to be issued in 2026. 

Understanding Medicare Compliance for Vascular Interventions 

The second work plan project is named “Medicare Payments for Lower Extremity Peripheral Vascular Procedures.” The OIG reports that peripheral vascular procedures in an office setting have increased among the Medicare population over the past decade.  

In fact, OIG says for calendar years 2022 and 2023, Medicare paid approximately $1.16 billion for lower extremity peripheral vascular procedures in office settings. Their concern is that these procedures are generally recommended only after patients have exhausted medical and exercise therapy and have lifestyle-limiting symptoms.  

The OIG plans to analyze Medicare fee-for-service for peripheral vascular procedures for questionable characteristics. They would also like to assess whether these procedures complied with CMS requirements and met applicable treatment guidelines. This report is expected to be released in 2025 under report number W-00-24-35914. 

Whistleblower Fraud Investigations Find Compliance Issues 

The OIG reported that there have been some whistleblower fraud investigations concerning these procedures. One case recently occurred in Florida where the whistleblower was a physician who claimed a vascular center and its providers were performing and billing for medically unnecessary peripheral vascular procedures.   

The government intervened in the case and alleged the providers submitted false claims to Medicare for percutaneous transluminal angioplasties that were not reasonably or medically necessary because they were performed without appropriate diagnostic imaging or clinical justification.   

The case was resolved when the medical providers agreed to pay $810,301, of which $337,625 was restitution. The defendants also agreed to pay $85,000 for the whistleblower’s reasonable expenses, including attorneys’ fees and costs. 

Report: Faster Treatment, Higher Costs with Office Procedures 

The Journal of Vascular Surgery published a report in June 2024 that concluded Medicare patients with peripheral artery disease are treated more quickly but undergo higher cost interventions in office-based laboratories compared to outpatient hospital settings. 

The authors used publicly available Medicare fee-for-service claims data spanning a five-year period that identified all patients undergoing certain peripheral procedures for certain conditions. They then evaluated the associations of patient and procedure characteristics with the site of service. 

Steps for Compliance in Peripheral Vascular Reimbursement 

So, what’s a compliance officer to do?  The first step is to determine the level of involvement the organization has in these particular procedures.  

If found to be significant, it’s probably wise to evaluate the clinical guidelines and policies in place for use of peripheral vascular procedures. Most organizations have a medical director or department chair who could guide a review to determine if procedures are medically necessary.  

Seek Out External Resources about PVD Compliance 

Alternatively, seeking external expertise is also an option. Though professional societies’ clinical practice guidelines are not the “end-all,” it might be useful to reference such guidelines as a starting point.  

These might include: 

• Society of Vascular Surgery

• American College of Cardiology/American Heart Association Joint Committe

• Society of Interventional Radiology

Best Practices for Peripheral Vascular Procedure Compliance  

Most compliance programs only perform medical coding reviews of the procedure documentation, but the OIG suggests including medical necessity audits as well. In their General Compliance Program Guidance (GCPG) document, they state, “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.” 

Given this, compliance professionals shouldn’t ignore the question of medical necessity for peripheral artery procedures. Scrutiny of these services continues to be a priority for the OIG and their work plan as well as the Department of Justice, as evidenced by cases that result either from data analytics or whistleblowers. 

Confident Compliance Starts Now 

YouCompli customers are confident in their approach to compliance challenges like managing PVD reimbursement. Learn more about the unique combination of expert human analysis and digital compliance management tools. 

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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