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.   

Download our Latest Whitepaper

Sign-up for our Weekly Newsletter

Schedule a quick overview

Download our Latest Whitepaper

Sign-up for our Weekly Newsletter

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

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.   

Download our Latest Whitepaper

Sign-up for our Weekly Newsletter

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.

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.   

Download our Latest Whitepaper

Sign-up for our Weekly Newsletter

Schedule a quick overview

• 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
• Transforming Compliance to a Department of Yes  by Lisa Herota, RHIA, CHC, CHPS, CCS Compliance & Privacy Officer
• 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
• Navigating Compliance Responsibility: A Foundation… by Amy Laufmann, MBA
• New Regulation– Now What? Step-by-Step Guide to… by Amy Laufmann, MBA

The post How to Avoid Compliance Risk in Peripheral Vascular Reimbursement   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

---

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

Without a good employee education program, your quality program can suffer. And without a good quality program, patient care can suffer. Compliance can partner with quality to mitigate legal and reputational risks through good education practices. 

This expert-written blog explains how to improve quality education programs and prepare employees to meet quality and compliance goals. To make the lesson stick, quality education is metaphorically compared to nail polish – an unlikely pairing but one that drives home the message brilliantly and memorably.  

Nail It Using These Timely Principles 

According to Wikipedia, nail polish is a lacquer applied to a human’s fingernails or toenails for various reasons, including suppressing cracking, looking and feeling your best, and highlighting your unique style.  

But there’s more to nail polish than a snappy color shade. When evaluating the quality of nail polish, good products should provide full coverage with fewer coats, have quality ingredients and protect your nails with shine.  

What does an educational program have to do with quality nail polish? Actually, several things. We compare quality management with this popular beauty regimen to reveal common principles to make your organization look and feel its best.  

• Full Coverage – Good for Nails and for Quality Education 
• Commit to Continuous Improvement in Education Program 
• Use Quality Ingredients for Quality Education and Quality Polish 
• Quality Training Covers and Protects, Like Good Polish 
• Make Quality Education Shine – Like Your Nails 

Self-Care – Good for Nails and Healthcare Organizations 

When people paint their nails, the result both looks and feels good. In fact, we can make a case that getting a manicure is a form of self-care.  Similarly, having a quality management program is a form of organizational self-care. Now, we would venture to guess that many businesses operate without a quality management program, and those businesses are obviously not concerned about future prosperity or being here 50 years from now. You probably are. It’s why you are reading this. And building a quality education program is part of a long-term strategy nurturing a more sustainable, resilient organization. 

High-quality nail polish should provide full coverage with fewer coats. Compliance and quality education programs should do the same. Comprehensive training should be designed to address the significant risks health care organizations face, which includes patient safety and quality of care.  

Commit to Continuous Improvement in Quality Training 

If you don’t have a continuous improvement program, you stagnate or you get worse, while your competitors who are focusing on quality get better.  

The main mission of quality is to standardize systems and processes, so the organization delivers repeatable, efficient outcomes and the highest quality of patient care. Without standard operating procedures (SOPs), a workforce operates as it sees fit without any form of documented control. Even worse is when all training is done by word of mouth. And when one of those trainers leaves, that essential training knowledge and skill go with them.  

Not sure how to organize a good, ongoing education program? We recommend you do what is doable, and you can read more about that in this article. Basically, it suggests that you simply identify the actions you can take and follow through on them.  

In developing your compliance education strategy, focus on the easiest opportunities first and establish reliable practices that don’t easily chip, like janky, low grade nail polish. This list could include training in reviewing data, handling incident reports, engaging in leadership meetings, and managing daily tasks.  

Acknowledge the situation, create a solid plan, prepare for unavoidable interruptions and make the most of your efforts. Commit to your training plan over time. Consistently show up and aim for gradual improvements. 

Use Quality Ingredients for Quality Education 

Good nail polish should resist chipping and fading for an extended period and add an extra layer of protection to what you do. The ingredients used in the lacquer play a role in delivering this result. 

Similarly, your education program should be based on solid ingredients for compliance-related training that doesn’t fade or chip. This is one of the ingredients of a quality management program, along with: 

• Written policies and procedures 
• Compliance program leadership and oversight 
• Effective lines of communication with compliance officer and disclosure programs 
• Enforcing standards with consequences and incentives 
• Risk assessments, auditing and monitoring, and responding to detected offensives   
• Development of corrective action initiatives 

These elements come directly from the Office of Inspector General of the US Department of Health and Human Services General Compliance Program Guidance (November 2023). The OIG’s stated purpose in issuing this information was to provide a reference guide for the healthcare compliance community and other healthcare stakeholders. It also covers other interesting information such as applicable laws and regulations, and compliance adaptations for large and small healthcare providers.  

Quality ingredients. Quality results. In both compliance and nail polish. 

Quality Training that Protects and Shines 

For quality nail care, you want a finish that adds shine and protects your nails. We recommend Color Street, which features patented technology with a base, color and topcoat all in one, while easily removable with polish remover. According to their web site, they are transforming the nail polish industry with salon-quality manicures in minutes, to have you looking and feeling your best, while rejuvenating nails and cuticles.  

For quality in training and education, you want the same end result. Your education program protects and shines when it is focused on the activities and risks of the organization. This training begins with learning about the role of the compliance officer, governing board, code of conduct and where to find information on compliance policies and procedures as well as non-retaliation provisions. 

Do we need to tell you again about the benefits of an effective education program and how it protects and makes your organization shine?  

Exactly.  

Make Compliance Education a Big, Shiny Deal 

Remember, while looks aren’t everything, the way you look is often part of any first impression that you give. Many people notice your face and hands initially, just as many employees will notice your onboarding and other educational programs first.  

Unkempt nails may lead people to think the rest of your life is just as messy. The same is true for educational programs. Lackadaisical training may lead people to think compliance isn’t that big a deal.  

Make a great impression and pay attention to the amount of care you give to your body and to your organization. A good compliance education program should provide full coverage with fewer sessions, draw on good ingredients, and protect your organization with confidence. 

Try the YouCompli system as a centralized hub for tracking compliance and quality processes throughout the areas of your organization. 

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

John is the Director of Quality at River Vista in Columbus, Ohio. He has worked in clinical research since 2003 and is inspired by the Irish professional wrestler Becky Lynch, whose personal and professional story centers on achievement, tenacity, grit, and overcoming adversity.  

Andrea has taught first grade in Willoughby, Ohio for 25 years. She earned a Bachelor of Science in elementary education from John Carroll University and a Master’s Degree in the Art of Teaching and Education from Marygrove College. 

Download our Latest Whitepaper

Sign-up for our Weekly Newsletter

Schedule a quick overview

The post Polish Your Quality Education Program  first appeared on YouCompli.

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

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

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

Tech Failure Leads to “Minor” Exclusion Screening Lag 

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

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

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

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

Billings Accrue for Excluded Individual Over 11 Months 

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

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

A Perfect Storm of Compliance Failure 

What followed was a perfect storm: 

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

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

Exclusion Screening as Compliance Practice and Risk Protection 

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

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

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

1. It’s a Legal Requirement. 

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

2. Non-Compliance = Massive Penalties 

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

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

3. Exclusions Are Not Always Obvious. 

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

4. Exclusions Can Happen at Any Time. 

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

5. It Protects Patients and Upholds Trust. 

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

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

So, What Happened at ABC Health? 

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

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

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

How to Avoid Exclusion Screening Problems 

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

Reference Material:   

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

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

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

Download our Latest White Paper

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

Our in-house team works tirelessly to monitor U.S. regulators, carefully read the regulations in their entirety, and translate the information into simple regulatory intelligence you can use. We deliver model procedures and expert tools that can be used to fulfill your business requirements. Everything is validated by a third-party law firm.   

Sign up for our Weekly Newsletter

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

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

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

How to Incorporate Quality and Safety into Compliance Practices 

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

1. Build a Strong Compliance Committee 

2. Provide Safe Reporting for Safety/Quality Concerns 

3. Get Your Governing Board Involved with Quality of Care 

4. Nurture Relationships with Quality and Safety Leaders 

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

1. Build a Strong Compliance Committee 

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

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

2. Provide Safe Reporting for Safety and Quality Concerns 

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

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

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

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

 

3. Get Your Governing Board Involved with Quality of Care 

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

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

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

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

4. Nurture Relationships with Quality and Safety Leaders 

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

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

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

Compliance, Quality and Safety — Together for Common Good 

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

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

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

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

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

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

---

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

---

Download our Latest Whitepaper

Sign-up for our Weekly Newsletter

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

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

The U.S. opioid epidemic holds important lessons for compliance professionals. This public health crisis is characterized by the widespread misuse of opioid drugs, leading to addiction, overdose deaths and a profound social and economic toll.  

This epidemic has evolved over the past few decades, and while there are many contributing factors, the role of pharmaceutical companies, particularly in the early stages, is widely seen as a critical element. 

The crisis began in the late 1990s, when prescription opioids such as oxycodone (OxyContin), hydrocodone, and morphine were increasingly prescribed to treat pain, which was often overestimated as being safely manageable. Opioids, while effective at managing pain, are highly addictive. 

Ethics and Epidemics Lead to Conflicts of Interest 

Pharmaceutical companies have played a significant role in the opioid epidemic, both in the development and marketing of opioids and in their sometimes-misleading promotion. In the 1990s, Purdue Pharma, the maker of OxyContin, introduced a new form of oxycodone with claims that it was less addictive than other opioids.  

Purdue and other pharmaceutical companies pushed doctors to prescribe opioids more freely for a wide range of pain, even for conditions that were not necessarily severe. They used misleading advertising and aggressive sales tactics to promote these drugs, minimizing risks and overemphasizing benefits. Pharmaceutical companies provided financial incentives to doctors through gifts, speaking fees and other perks, encouraging them to prescribe opioids.

This created a conflict of interest, as doctors were incentivized to prescribe these medications despite the risks of addiction. The overprescription of opioids led to millions of people becoming addicted to prescription painkillers, which contributed to the subsequent heroin and fentanyl crises. 

HHS OIG Investigations and Audits Drive Accountability 

The Department of Health and Human Services Office of Inspector General (HHS OIG) plays a critical role in investigating and enforcing actions related to the abuse and diversion of prescription opioids. The HHS OIG is tasked with overseeing and ensuring the integrity of various health-related programs, including Medicare and Medicaid, and ensuring that organizations, such as pharmaceutical companies, comply with federal regulations. In the context of the opioid epidemic, the HHS OIG’s responsibilities are multi-faceted, including fraud and abuse enforcement, corporate accountability, audits of pharmaceutical practices, and civil and criminal penalties.  

By holding pharmaceutical companies, healthcare providers, and individuals accountable for their roles in opioid abuse and diversion, the HHS OIG contributes to efforts to curb the crisis and prevent further harm. Their work, often in collaboration with other agencies, ensures that federal programs and public health initiatives are not inadvertently supporting the misuse of opioids, and they play a key role in enforcing regulations aimed at protecting public health. 

The Purdue Pharma and McKinsey Case 

The Purdue Pharma and McKinsey & Company settlement case was a significant development in the opioid epidemic, highlighting the roles that both the pharmaceutical company and its consulting firm played in fueling opioid misuse. Purdue Pharma, the maker of OxyContin, faced numerous lawsuits for its deceptive marketing practices, including downplaying the addictive nature of its product and aggressively promoting its use to doctors.  

According to court documents, in May 2013, Purdue Pharma engaged McKinsey & Company, a global consulting firm, to recover lost OxyContin sales. Purdue retained McKinsey to conduct a rapid assessment of the underlying drivers of OxyContin performance, identify key opportunities to increase near-term OxyContin revenue, and develop plans to capture priority opportunities.  

This 2013 effort was called Evolve to Excellence, or “E2E,” and included McKinsey advising Purdue on how to “turbocharge” the sales pipeline for OxyContin by, among other strategies, intensifying marketing to High Value Prescribers.  

Charges and Legal Action Lead to Historic Settlement 

In 2020, Purdue Pharma reached a historic $8 billion settlement with the U.S. Department of Justice, admitting to criminal charges of conspiring to mislead the public and healthcare providers about the risks of OxyContin. As part of the settlement, Purdue also filed for bankruptcy and agreed to restructure itself into a public-benefit corporation, with proceeds from its future profits going toward opioid addiction treatment and prevention efforts. 

McKinsey & Company faced legal action for its role in advising Purdue Pharma on sales strategies that prioritized increased opioid prescriptions. Martin Elling, a former senior partner at McKinsey & Company, waived his right to indictment and pleaded guilty to one count of knowingly destroying records with the intent to impede, obstruct, and influence the investigation and proper administration of a matter within the jurisdiction of the Department of Justice (DOJ).  

As announced in January, McKinsey & Company agreed to pay $650 million to resolve criminal and civil investigations into the firm’s consulting work with opioids manufacturers, including Purdue Pharma, LP. The VA OIG, Food and Drug Administration Office of Criminal Investigations, FBI, HHS OIG, and Office of Personnel Management OIG investigated this case, with assistance from the Department of Justice Computer Crimes and Intellectual Property Section. 

McKinsey & Company’s lack of integrity in its role as a healthcare consultant during the opioid crisis has had profound social, ethical, and public health consequences. The company’s actions serve as a cautionary tale about the dangers of placing profit motives over moral responsibility and the long-lasting impact such decisions can have on society. 

Implications and Impact for Healthcare Compliance Leaders 

This case has significant implications for healthcare compliance officers as well as consulting advisors. These professionals are responsible for ensuring that healthcare organizations and their business partners operate within the bounds of legal and ethical standards, protecting public health and avoiding harmful practices. The lessons learned from the Purdue and McKinsey cases underscore the critical importance of integrity, oversight, and accountability in both healthcare organizations and the consulting industry. 

Lessons learned: 

• Healthcare organizations need to strengthen oversight and monitoring of third-party relationships, ensuring that consultants and contractors act in compliance with the law and adhere to ethical guidelines.  
• Healthcare compliance officers must create and enforce policies that prioritize patient health over profits.  
• Consultants must be prepared to provide ethical guidance, even when it may not align with clients’ short-term financial interests.   
• Consultants must understand the risks and reputational damage that can arise from unethical advice. 

The Purdue Pharma and McKinsey investigation serves as a pivotal case for healthcare compliance officers and consultants, emphasizing the need for ethical guidance, transparency and accountability in all aspects of healthcare operations. Both groups must be vigilant about the potential risks of unethical advice and practices, and they must work to protect patients, safeguard public trust, and prevent further harm. These cases underscore that healthcare professionals, including consultants, have a duty to prioritize the well-being of patients and act in compliance with both legal and ethical standards. 

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).  

Download our Latest White Paper

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

Our in-house team works tirelessly to monitor U.S. regulators, carefully read the regulations in their entirety, and translate the information into simple regulatory intelligence you can use. We deliver model procedures and expert tools that can be used to fulfill your business requirements. Everything is validated by a third-party law firm.   

Sign up for our Weekly Newsletter

The post What Happens When Integrity and Accountability Fail: Lessons for Compliance Professionals  first appeared on YouCompli.

The HHS OIG recently issued its first Industry Segment-Specific Compliance Program Guidance, or ICPG, with many more expected.  This first ICPG covers Skilled Nursing Facilities and Nursing Facilities.  

Let’s review some of the highlights. 

1. Quality of Care and Quality of Life 

For decades, the OIG and other government enforcement agencies have emphasized the importance of the quality of care and quality of life for nursing facility residents.   

When a nursing facility submits a claim to Medicare or Medicaid for reimbursement, it certifies the services were provided in compliance with all applicable statutes, regulations, and rules. If a nursing facility does not provide care consistent with professional standards of quality, or in an environment that promotes quality of life, claims for reimbursement may be considered false.   

The ICPG provides the following examples of quality and related safety concerns that can lead to submission of false claims:  

• providing medically unnecessary or grossly substandard services 
• housing residents in unacceptable or dangerous living conditions 
• failing to provide residents with activities 
• failing to provide residents with needed psychiatric care 

2. Billing Requirements 

The ICPG states, “Ensuring compliance with Medicare and Medicaid billing requirements should be a core function of nursing facility compliance program operations.” 

The OIG expects nursing facilities to be proactive in their oversight of billing compliance. This includes conducting regular reviews to ensure billing and coding practices are current and accurate, as well as performing regular internal billing and coding audits. Even if an entity makes an isolated billing error, that entity still has an obligation to repay the overpayment to avoid False Claims Act liability. 

The ICPG specifically addresses the following risk areas associated with billing requirements: 

• SNF Prospective Payment System (PPS)  
• Value-Based Payment Models and Programs 
•  Medicare Advantage and Medicaid Managed Care  
• Medicare Part D  
• Medicare Health Plan Enrollment for Nursing Facility Residents 

Interestingly, the ICPG for nursing facilities also refers readers to a supplement on understanding reimbursement for nursing facilities, which can be viewed at https://oig.hhs.gov/documents/compliance/10039/nf-icpg-supplement.pdf. 

3. Anti-Kickback Risks 

The OIG’s General Compliance Program Guidance (GCPG) highlighted some of the risks associated with the Federal Anti-Kickback Statute (AKS) in the healthcare industry. The nursing facility ICPG provides many helpful and specific AKS risks to unique to nursing facilities. Among the specific risks highlighted by the OIG are: 

• Free (or Below Fair Market Value) Goods and Services  
• Discounts 
• Arrangements for Services and Supplies  
• Long-Term Care Pharmacy and Consultant Pharmacist Arrangements  
• Hospital Arrangements  
• Hospice Arrangements  
• Care Coordination and Value-Based Care Arrangements  
• Joint Ventures 

The ICPG emphasizes that all referral relationships call for vigilance under the Federal AKS. The discussions in the ICPG not only highlight several risk areas for nursing facilities under this law, but it also provides excellent recommendations for mitigating those risks. OIG also stresses that nursing facilities should scrutinize the listed risk areas as part of their risk assessment, internal review, and monitoring processes. 

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  

The post Breaking Down the OIG’s First Industry-Specific Guidance  first appeared on YouCompli.