Durable Medical Equipment (DME) billing remains a significant target of the government with regard to compliance risks. The insights and strategies in this blog offer guidance to help health systems avoid exposure and losses from DME fraud. 

Recently, CMS announced that 11 DME companies have been barred from receiving future Medicare Advantage (MA) Part C and D payments. The CMS decision is based on suspected fraudulent billing to the tune of $3.4 billion. 

The suspicious activity was based on the following where the company: 

• Submitted no claims prior to 2025 
• Used improper billing practices for their claims 
• Billed for medical equipment to patients who were already deceased 
• Supplied equipment to patients who either never requested it or received it 

The companies are known as DMEPOS suppliers: durable medical equipment, prosthetics, orthotics and supplies.   

These 11 organizations and the resulting issues aren’t the only examples of DME dollars at risk of fraud, waste and abuse.  

Health Systems Not Immune to Exposure from DME Risks 

While DME fraud often originates with third-party suppliers, health systems are subject to direct operational and financial exposure. Compliance leaders who actively combat these schemes protect organizational revenue, preserve physician credentials, and prevent costly administrative disruptions.  

Proactive fraud mitigation ensures seamless patient care while shielding health systems from aggressive federal audit scrutiny. It involves many goals that are already within the compliance mission: 

• Protecting physician credentials and NPI integrity 
• Fulfilling strict recordkeeping and order requirements 
• Safeguarding patient care and trust 
• Reducing downstream audit burden 
• Ensuring Medicare Advantage network integrity 

For example, fraudulent suppliers routinely harvest physician National Provider Identifiers (NPI) to generate fake orders for items like catheters, orthotics and glucose monitors. Proactive oversight prevents unauthorized order generation using health system provider credentials and protects clinicians from CMS sanction lists. 

Other Areas of Government Focus: Catheter Audit Example 

In addition to wide sweeping announcements like the one above about the 11 DME companies, other government agencies are focusing on specific types of supplies that might be vulnerable to fraud, waste and abuse.   

For example, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) published the results of an audit they performed related to Medicare payments for intermittent urinary catheters.   

Intermittent urinary catheters are covered under the Medicare Part B benefit for prosthetic devices for people who have permanent impairment of urination (i.e., permanent urinary incontinence), involuntary loss of urine, or permanent urinary retention (inability to voluntarily empty the bladder or pass urine). A treating practitioner orders catheters for an enrollee, and a supplier fulfills the order. 

OIG Audit Finds $35+ Million in Improper Catheter Payments 

OIG audited a period during which Medicare paid $303 million for these types of catheters. Based on the error rate in the sample used for the audit, OIG estimated that Medicare improperly paid $35.1 million for the catheters.   

They cited examples where medical records didn’t support enrollees’ eligibility for curved-tip catheters or sterile catheter kits. For other claims in their sample, suppliers didn’t meet Medicare requirements for catheter refills, proof of delivery, or a standard written order. 

Stopping Medical Device Scams at the Patient Level 

Beyond this auditing work, OIG also issued a Consumer Fraud Alert for Urinary Catheter Scams. The fraud alert informs patients that scammers are targeting Medicare enrollees through phone calls, internet ads, and text messages with offers of free services, medical equipment, or gift cards after confirming their personal information and eligibility for specific Medicare services.  

Often, the enticement for the individual is that they are “qualified” for items “at no cost” or “free.” Once the scammers obtain the enrollee’s personal information, monthly billing to Medicare will begin for medically unnecessary urinary catheters that may or may not actually be sent to the enrollee. 

Three Areas to Monitor to Avoid DMEPOS Fraud 

OIG has demonstrated their commitment to addressing fraud, waste and abuse challenges in the DME sector. In this white paper, “The Nation’s Challenge to Combat Durable Medical Equipment Fraud in Medicare,” OIG presents actions that CMS and others can take to stop bad actors from exploiting Medicare.   

It focuses on three key elements that bad actors need to commit DMEPOS fraud: 

1. Medicare-enrolled DMEPOS supplier 

2. Physician order for DMEPOS product

3. Medicare enrollee’s identification number 

1. How to Combat Medicare-enrolled DMEPOS Supplier Fraud 

Maintaining strict referral standards prevents regulatory non-compliance and protects payer contract relationships. Health systems and affiliated provider networks must screen against the CMS Preclusion List and verify supplier enrollment. 

Actions that OIG suggests CMS should take: 

• Strengthen on-site inspections to prevent bad actors from enrolling in Medicare. 

This could include additional unannounced on-site inspections to ensure bad actors can’t predict when site visits will occur. 

• Improve detection of unreported changes of ownership and straw owners. This might include using AI or other technologies on an ongoing basis to identify changes in ownership that have not been reported to CMS. 
• Ban suppliers from using paper applications to circumvent oversight. 
• Increase oversight of newly enrolled DMEPOS suppliers. This could include CMS implementing a period of enhanced oversight of newly enrolled DMEPOS suppliers and those that recently changed ownership. 
• Reassess and potentially update surety bond requirements to better deter fraud. 
• Require all DMEPOS suppliers that bill Medicare Advantage to enroll in Medicare. 

2. How to Combat Fraud in Physician Orders for DMEPOS  

When CMS or OIG audits target improper supplier claims, health systems must produce matching clinical documentation to avoid administrative claw backs and penalties. Federal regulations require ordering physicians to maintain clinical records supporting medical necessity for seven years. 

Actions that OIG suggests CMS should take: 

• Engage ordering physicians in fraud-fighting efforts. CMS could develop an electronic verification method for physicians to confirm orders before certain claims are paid. Or CMS could issue reports to physicians detailing the DMEPOS they ordered and request that physicians review the information and report any fraudulent billing. 
• Harness new technologies and analytic tools to better detect and stop payments for fraudulent DMEPOS claims. OIG recommends that CMS explore the potential for using AI in this area. 
• Enhance the use of payment suspensions. 
• Expand medical reviews to prevent fraud. 
• Work with secondary payers to stop fraudulent billing. CMS recently began sharing payment suspension information with secondary payers to help them prevent payments to potentially fraudulent suppliers. 
• Require Medicare Advantage organizations to submit the identification number for physicians who order DMEPOS. 

3. How to Combat Fraud in Medicare Enrollee ID Numbers 

Schemes that target patients with unsolicited, unnecessary or low-quality equipment disrupt care plans and harm patient trust. Robust compliance workflows ensure discharge planners and care coordinators connect patients exclusively with legitimate, Medicare-enrolled suppliers. 

Actions that OIG suggests CMS should take: 

• Discontinue or better protect enrollee lookup tools. 
• Prohibit DMEPOS suppliers from all types of unsolicited contact with enrollees. 
• Partner with social media companies to prevent sale of enrollee identification numbers on their platforms. 
• Engage Medicare enrollees in the fight against fraud. 

Needless to say, DME is an area fraught with fraud, waste and abuse risk, and government enforcement agencies are focusing more on DME, not less. If your organization participates in this space, make sure your compliance program is preparing against the various DME compliance risks we’ve talked about here and others as they arise. 

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About the author 

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 What Health Systems Need to Know about DME Billing Fraud:  Three Areas to Watch  first appeared on YouCompli.

Everyone has someone they report to, and for the OIG, one of those bosses is the U.S. Congress. Twice a year, the OIG submits a report to “the boss”, summarizing some of their significant activities and tooting their own horn, so to speak.  

OIG Reveals Impressive Return in Expected Recoveries and Receivables 

In a recent report, the OIG announced a $12.70 return in expected recoveries and receivables for every $1 invested, an ROI any of us would love to have.

For the most recent six-month period, OIG also reported substantial financial and enforcement activity to Congress.

Report Reveals Advance Insights into OIG Game Plan

The report also provides insight into areas OIG may plan to target. These four areas are especially worth watching for compliance professionals.

1. Criminal and Civil Enforcement Highlights 

OIG highlighted many cases, but a couple are especially likely to catch compliance professionals’ attention: 

Wound Graft False Claims Fraud Results in Prison, Restitution and Settlement 

The owners of several wound graft companies were sentenced to prison, ordered to pay restitution, and agreed to pay a settlement to resolve False Claims Act liabilities. OIG reported that these individuals ran a nationwide scheme targeting Medicare patients that resulted in orders for medically unnecessary, oversized skin grafts. They also accepted millions of dollars in illegal kickbacks and directed nurse practitioners to apply unwarranted grafts, resulting in more than $1.2 billion in fraudulent claims submitted to Federal health care programs.  

Convicted Physician Excluded from Federal Health Programs for 50 Years 

A rheumatologist was excluded from participating in Federal health care programs for 50 years after being convicted of health care fraud involving more than $118 million in false claims. Specifically, the OIG reported that the doctor falsely diagnosed patients with chronic illnesses to bill for tests and treatments that were medically unnecessary. These false diagnoses led patients to receive unnecessary treatments, including injections, infusions and X-rays.  

2. OIG Financial Integrity Efforts Target Improper Payments 

Knowing the possible OIG focus areas helps compliance professionals when they are performing risk assessments, auditing and monitoring. You can get a sense of where OIG is looking and where you might need to assess and prepare.  

Relating to financial integrity, the OIG highlighted areas of their work designed to prevent and detect improper payments. Noteworthy examples included: 

Autism Services 

OIG determined that two states (Maine and Colorado) made improper Medicaid payments for applied behavior analysis (APA), which is a behavioral therapy often used to help individuals with autism.  

Maine made an estimated $45.6 million ($28.7 million Federal share) in improper payments and an estimated $22.4 million ($14.2 million Federal share) in potentially improper payments. Colorado made an estimated $77.8 million ($42.6 million Federal share) in improper payments and an estimated $207.4 million ($112.5 million Federal share) in potentially improper payments.  

Durable Medical Equipment (DME) 

OIG looked at payments for a 7-year period for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) that were provided during inpatient stays. They found that $22.7 million in Medicare payments to suppliers should not have been paid.  

The overpayments were a result of system edits to CMS’s claims processing system for Medicare Parts A and B that were not working properly to prevent or detect such overpayments.   

Managed Care Enforcement 

OIG continues to emphasize concerns with potential overpayments in Medicare Managed Care. In addition to their publishing the Industry Segment-Specific Compliance Program Guidance for Medicare Advantage, they also highlighted two large settlements. 

The first was a $556 million settlement with five Kaiser Permanente affiliates to resolve False Claims Act allegations that they systematically submitted invalid diagnosis codes for Medicare Advantage enrollees to receive inflated payments.   

The second settlement was with Aetna, which agreed to pay $117.7 million to resolve allegations under the False Claims Act that it submitted, or failed to retract inaccurate Medicare Advantage diagnosis codes to inflate payments from CMS. The insurer certified and maintained false and unsupported patient diagnoses, including for morbid obesity and chart review coding, resulting in overpayments.  

3. Patient Safety Gets Continued Emphasis in OIG Plan 

Compliance professionals know that over recent years, the OIG has emphasized patient safety in much of their guidance. In their report to Congress, OIG again highlights activities around protecting people from harm.  

Examples 

• A physician in Michigan who was excluded from participating in Federal health care programs for 60 years based on convictions of criminal sexual misconduct. 
• Work overseeing improper use of antipsychotic medications in nursing homes. 
• 64% of nursing homes received a serious deficiency within three years of graduating from the CMS Special Focus Facility program, which is supposed to address quality problems at the poorest performing nursing homes with track records of serious noncompliance.  
• Nursing home owners in New Jersey were excluded from Federal health care programs for cost-cutting activity that resulted in facility residents being neglected, abused, receiving inadequate medical care and residing in unsanitary conditions. 
• A nursing facility CEO was sentenced to prison for diverting funds for personal enrichment when those funds were intended for resident care. With the resulting lack of funds for care, the facility was understaffed and unsafe. 

4. Integrity of Grants and Contracts Puts Millions at Risk 

HHS offers a significant number of grants and enters into many contracts, and OIG is looking at compliance with requirements associated with grants and contracts.  

Examples 

• Compliance With Federal Contracting Requirements–Administration for Children and Families (ACF) 
• Gaps in National Institutes of Health (NIH) oversight put millions in funding for “Other Transactions” at greater risk of fraud, waste or abuse. 
• A cancer institute agreed to pay $15 million to settle False Claims Act allegations that it caused the submission of false claims to NIH related to scientific grants. The institute admitted that between 2014 and 2024, it used NIH funding to support cancer research publications containing misrepresented, duplicated, rotated, magnified or stretched images, often depicting different experimental conditions or timepoints across 14 journal articles tied to six NIH grants.  

Compliance Leaders Can Find Clues in OIG Plan 

As you assess your organization’s compliance risks, look for clues in these four areas and others included in the OIG plan submitted to Congress. With their impressive return on investment, the OIG is likely to continue to receive the resources they need to prevent, detect and enforce compliance, and their plan likely shares some of their roadmap. 

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 Where Does the Recent OIG Plan Focus? Highlights of Note  first appeared on YouCompli.

Are you keeping up on your reading from the FY 2027 hospital inpatient prospective payment system (IPPS) Final Rule? True, it is close to 900 pages of Federal Register fine print, (https://www.govinfo.gov/content/pkg/FR-2026-08-04/pdf/2026-15833.pdf ) but there are four areas that prepared compliance professionals should be aware of. This blog takes you through the highlights of those important sections. 

What Does the Final Rule Mean for Your Organization? 

This release updates Medicare payment rates and policies for acute care and long-term care hospitals, with some starting as soon as January 1, 2027, so it’s definitely time to start paying close attention. 

1: Expansion of Comprehensive Care for Joint Replacement (CJR) Model 

The original CJR Model ran from April 2016 through December 2024 and according to CMS, it produced the needed results. The most recent evaluation of performance years six and seven (2021-2023) showed that the CJR Model produced an estimated $112.7 million in net savings while maintaining quality of care. 

Now, the CMS Innovation Center is expanding the model nationally, including in U.S. Territories, starting January 1, 2028. The expanded model, called CJR-X, will focus on improving care and reducing spending for Medicare beneficiaries undergoing lower extremity joint replacement (LEJR) procedures.  

CJR-X Mandatory Requirements for Some Acute Care Hospitals 

Participating hospitals will be held accountable for spending and quality of care during an inpatient stay or hospital outpatient procedure and for the 90 days following hospital discharge.  With some exceptions, the CJR–X Model will be mandatory for acute care hospitals paid under IPPS and Outpatient Prospective Payment Systems (OPPS).  

Multiple Modifications to CJR Model 

CJR–X also includes modifications to the CJR Model. The Final Rule confirms multiple policies for CJR-X.  These include: 

• January 1, 2028 start date 
• Acute care hospitals as participant and accountable entity 
• LEJR as the episode of care 
• Five quality measures and a composite quality score (CQS) to assess quality performance  
• Regional risk-adjusted target prices that include capped normalization and trend factors 
• Pricing-specific policies for certain hospitals, such as low-volume and safety net hospitals 
• Provider and beneficiary overlap permitted with most models 
• Allows participant hospitals to have financial arrangements 
• Waives certain Medicare program requirements 
• Permits beneficiary-identifiable and regional aggregated data sharing 
• Options for Alternative Payment Model (APM) participation  

Though compliance professionals aren’t likely to be named the implementation lead of these efforts at their hospital, they should still be aware of how these changes will affect reimbursement, quality reporting and allowances for financial arrangements. 

To learn more now and in the future about the CJR-X Model, stay tuned at https://www.cms.gov/priorities/innovation/innovation-models/cjr-x 

2: Organ Acquisition Costs 

Compliance professionals working in or with organizations providing organ acquisition services need to be aware of these changes and ensure policies, procedures and any auditing activity is adjusted accordingly. 

• The Final Rule outlines payment policies for organ acquisition and reasonable cost, as well as reimbursement appeals for Independent Organ Procurement Organizations (IOPOs) and Histocompatibility Laboratories (HCLs).   
• The Final Rule solidifies the proposal to clarify and codify certain longstanding policies on allowable costs under Medicare’s reasonable cost principles for all provider types, including public education for organ procurement organizations.  
• Additionally, it finalizes the proposal to clarify and codify Medicare’s longstanding policies for allocating overhead costs across all provider types.  
• Lastly, the final rule codifies the CMS administrator’s discretionary review of reimbursement appeals for IOPOs and HCLs.  

As HHS OIG states in their General Program Compliance Guidance, “One of the best ways to identify fraud and abuse risks is to follow the money.” Understanding the flow of money related to organ acquisition is one of those areas to add to the list for “following the money.” 

3. Quality, Quality, Quality. 

Quality of care is another area that the HHS OIG has been shining a light on for compliance professionals in recent years. Though it’s unlikely compliance professionals will take over quality of care programs in hospitals, OIG expects tight partnerships. Also expected is a general understanding by compliance departments of the work that hospitals’ quality of care teams perform. 

Specifically, OIG said, “Entities should incorporate quality and patient safety oversight into their compliance programs. Integrating quality and patient safety oversight into compliance processes can alert the entity of quality and patient safety concerns and enable the entity to mitigate risk of patient harm.” 

Quality Reporting and Compliance Impact 

The IPPS Final Rule has a lot to say about quality reporting. Although compliance professionals aren’t on the front line for some changes, they should ensure quality teams are aware and have a plan to address any potential impact.  

Quality-related highlights include: 

1. Adoption of three new measures: 

• Excess Days in Acute Care After Hospitalization for Diabetes measure beginning with the FY 2029 payment determination 
• Hospital Harm-Postoperative Venous Thromboembolism electronic clinical quality measure (eCQM) beginning with the FY 2030 payment determination 
• Advance Care Planning eCQM beginning with the FY 2030 payment determination 

2. Removal of three measures, beginning with FY 2030 payment determination:  

• Venous Thromboembolism Prophylaxis eCQM 
• Intensive Care Unit Venous Thromboembolism Prophylaxis eCQM 
• Discharged on Antithrombotic Therapy eCQM 

3. Modifications to three measures beginning with the FY 2028 payment determination. All are related to Excess Days in Acute Care after Hospitalization for: 

• Acute Myocardial Infarction 
• Heart Failure 
• Pneumonia 

4. Five modified mortality measures beginning with the FY 2028 payment determination.  Each relates to the Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate following: 

• Acute Myocardial Infarction Hospitalization  
• Heart Failure Hospitalization 
• Pneumonia Hospitalization  
• Chronic Obstructive Pulmonary Disease Hospitalization  
• Coronary Artery Bypass Graft Surgery  

4: Promoting Interoperability of Certified Electronic Health Record Technology 

The Medicare Promoting Interoperability Program encourages eligible hospitals and critical access hospitals to adopt, implement, upgrade and demonstrate meaningful use of certified electronic health record technology (CEHRT). 

In this Final Rule, CMS confirmed policies to: 

• Remove and revise certain criteria to align with proposals made by the Office of the National Coordinator for Health IT 
• Remove certain attestations  
• Delay removal of the following two measures: (i) Support Electronic Referral Loops by Sending Health Information and (ii) Support Electronic Referral Loops by Receiving and Reconciling Health Information  
• Modify the Electronic Prior Authorization measure as an optional bonus measure for the EHR reporting period in CY 2027 and mandatory beginning with the EHR reporting period in CY 2028 
• Add the Unique Device Identifiers for Implantable Medical Devices measure  
• Adopt two new eCQMs beginning with the FY 2030 payment determination in alignment with the Hospital Inpatient Quality Reporting Program 
• Remove three eCQMs beginning with the FY 2030 payment determination in alignment with the Hospital Inpatient Quality Reporting Program  

Build Business Knowledge to Anticipate Non-Compliance Risks 

Most compliance professionals are unlikely to be the assigned project lead on any of these announcements within their individual hospitals. But good compliance professionals need to understand their organization’s business lines and operations to anticipate where non-compliance could most likely occur. 

For those working with or for hospitals, the Hospital IPPS Final Rule is always a good place to review upcoming changes to hospital reimbursement, government policies and data reporting requirements.  

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.   

Stay Informed on Medical Necessity and More 

Read other blogs by Dr. CJ Wolf on YouCompli to stay current on information compliance leaders need. He covers these and other topics:  

• Regulatory and Enforcement Updates: Breaks down OIG Work Plan priorities, CMS policy updates, and healthcare regulatory changes. 
• Compliance Auditing and Risk: Offers practical advice on risk assessments, internal auditing, and building effective compliance programs. 
• Billing and Documentation Integrity: Examines compliance strategy related to coding integrity, medical necessity, and operational oversight. 

Here are a couple of articles to get you started. 

Don’t Let Pain Injections Cause Regulatory Compliance Pain 

The regulatory compliance landscape around SI joint injections is dynamic and significant. It’s worth paying attention to those devilish details.   

Four Areas of Noncompliance in SI Joint Injection Procedures  

Below are four categories of noncompliance and indications of unmet requirements: How SI Joint Injections Are Covered 

Medical Necessity: A Guide for Healthcare Compliance Leaders 

Ensuring medical necessity for services or supplies is 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 piece explains 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.

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The post Four Things to Know About the FY 2027 IPPS Final Rule  first appeared on YouCompli.

The HHS OIG recently released an audit report in which they concluded that for a recent one-year period, Medicare improperly paid physicians approximately $15.2 million for sacroiliac joint (SI) injections (see: https://oig.hhs.gov/reports/all/2026/medicare-improperly-paid-physicians-an-estimated-152-million-for-sacroiliac-joint-injections/).  

SI injections can help some patients improve their spinal mobility as well as relieve pain. Medicare covers these injections under certain conditions but not others. That’s where confusion can create painful compliance risks. 

Most Recent Audit in Series Related to Spinal Pain Management Services 

This was the most recent audit in a series of audits related to spinal pain management services which the OIG has been performing over many recent years.  

In prior audits of similar spinal services, the OIG found, for example, that Medicare improperly paid physicians for facet-joint interventions for more than 50 percent of sampled services that didn’t comply with one or more of the Medicare requirements:  

• https://oig.hhs.gov/reports/all/2023/medicare-improperly-paid-physicians-an-estimated-30-million-for-spinal-facet-joint-interventions/ 
• https://oig.hhs.gov/documents/audit/9596/A-09-20-03003-Complete%20Report.pdf 
• https://oig.hhs.gov/documents/audit/9602/A-09-20-03010-Complete%20Report.pdf  

They also reported finding improper payments associated with epidural steroid injections: 

• https://oig.hhs.gov/reports/all/2023/medicare-improperly-paid-physicians-for-epidural-steroid-injection-sessions/ 

Audits Continue in Therapeutic Spinal Pain 

In addition, last year, they published audit findings that said Medicare could have saved an estimated $17.7 Million if CMS oversight had prevented at-risk payments for anesthesia administered during spinal pain management procedures: 

• https://oig.hhs.gov/reports/all/2025/medicare-could-have-saved-an-estimated-177-million-if-cmss-oversight-had-prevented-at-risk-payments-for-anesthesia-administered-during-spinal-pain-management-procedures/  

Consequently, it should come as no surprise to healthcare compliance professionals that the audits in the therapeutic spinal pain space continue with the recent report about SI joint injections. 

Background on Crucial SI Joints 

The SI joints connect the lower portion of the spine to the pelvis. 

They support upper-body weight and play an important role in walking and changes in posture or position, such as moving from standing to sitting. These joints become painful for various reasons, including sacroiliac joint dysfunction, which occurs when the joint moves too much or too little, often due to injury, pregnancy or osteoarthritis.  

To improve movement and relieve lower back pain, a physician may administer an SI joint injection. A diagnostic injection is first used to determine whether the SI joint is the source of the pain. Significant immediate pain relief following the injection strongly suggests that the SI joint is responsible.  

(Image from page 2 of the OIG report) 

Once the SI joint is confirmed as the pain source, a therapeutic injection may be administered, with pain relief potentially lasting up to six months. 

How SI Joint Injections Are Covered 

Medicare Part B covers SI joint injections when medically reasonable and necessary. Five of seven Medicare Administrative Contractors (MACs) have local coverage determinations (LCDs) outlining requirements for  

• Pain indications 
• Imaging and pain assessment 
• Coverage limits  
• Diagnostic and therapeutic injections 

These LCDs limit coverage to two diagnostic and four therapeutic injection sessions within a rolling 12-month period, whether performed unilaterally or bilaterally.  

Billing and Coding for SI Joint Injection Procedures 

Each MAC also issued billing and coding guidance stating that physicians must add the “KX” modifier to each claim line for diagnostic injections to distinguish them from therapeutic injections. (Appendix C of the OIG Audit report summarizes the MACs, the states they cover, and the specific LCD number and LCD Reference article pertinent to their audit.) 

CPT code 27096 is used for injections made directly into the sacroiliac joint, while CPT code 64451 is used for injections targeting the nerves that innervate the sacroiliac joint. 

OIG Selects 100 Random Samples out of 186,000+ Procedural Sessions 

For the audit report, the OIG selected a random sample of 100 SI joint procedural sessions from a population of 186,842 sessions paid for by five MACs in a one-year period. They requested physicians’ supporting documentation to determine if the claims met Medicare requirements including LCD and LCD Reference Articles.   

Of the 100 sampled sessions, 28 complied with Medicare requirements, and 75 complied with Medicare billing guidance. However, the remaining 72 sessions didn’t comply with Medicare requirements, and 25 didn’t comply with Medicare billing guidance.  

Seventy-two sampled sessions didn’t comply with one or more of the requirements. The OIG report summarizes the noncompliant sessions by the type of noncompliance observed: 

(The total exceeds 72 sessions because 41 sessions had more than one deficiency.) 

Estimated Improper Payments of $15.2 Million in Sample Universe 

OIG then extrapolated their findings across the entire population of 186,842 sessions and calculated overpayments to determine their estimated improper payment amount of $15.2 million for the universe of sessions sampled for the one-year period. 

OIG found that although CMS had systems to identify some billing errors, it didn’t provide enough additional oversight or education to help physicians understand and follow Medicare requirements. CMS relied on MACs to educate physicians, but this wasn’t sufficient.  

As a result, some physicians may not have fully understood the requirements and billing rules. Physicians with billing errors said that more frequent and consistent training would have helped them understand the rules and avoid future errors. 

Other Improper Payments Assumed, Potentially Pushing Total Higher 

As mentioned, the sample universe of SI joint procedural sessions was limited to the five of the seven MACs that had issued LCDs. The other two MACs that didn’t have LCDs paid physicians $12.3 million for sacroiliac joint injection sessions. That accounts for approximately 36 percent of total Medicare payments for sacroiliac joint injections nationwide.   

Since these sessions were excluded from the audit, OIG wrote that this set of payments to physicians may also include improper payments. If true, the estimated $15.2 million in improper payments could potentially be higher. 

Four Areas of Noncompliance in SI Joint Injection Procedures 

Below are four categories of noncompliance and indications of unmet requirements: 

1 – Indications of Pain Requirements Not Met 

• At least three positive findings with provocative maneuvers 
• Low back pain below the L5 vertebra without radiculopathy 
• Low back pain that persists despite a minimum of four weeks of conservative therapies 
• Clinical findings and imaging studies that do not suggest any other diagnosed or obvious cause of the lumbosacral pain such as tumor and fracture 
• Low back pain for at least three months 
• Moderate to severe low back pain primarily experienced over the anatomical location of the sacroiliac joints between the upper level of the iliac crests and the gluteal fold 

2 – Imaging and Pain Assessments Requirements Not Met 

• The sacroiliac joint primary pain level must be measured prior to the injection at the beginning of the session. 
• The post procedure pain level must be measured at the end of the session. 
• The injections must be performed under computed tomography (CT) or fluoroscopy image guidance with contrast unless the patient has a documented contrast allergy so that ultrasound guidance without contrast may be considered. 

3 – Diagnostic or Therapeutic Sacroiliac Joint Injections Requirements Not Met 

• A diagnostic injection must have provided a minimum of 75 percent relief of primary pain before a therapeutic injection is administered 
• A subsequent therapeutic injection is not reasonable and necessary when the prior therapeutic injection did not result in at least 50 percent consistent pain relief or functional improvement for at least three months 

4 – Limitation of Coverage Requirements Not Met 

• Administer other musculoskeletal injections in the lumbosacral spine during the same session as sacroiliac joint injections 
• Perform multiple injections (e.g., epidural steroid injections, facet-joint injections, and trigger point injections) during the same session as sacroiliac joint injections and during the period when the physician is evaluating whether the injection reduced pain (i.e., efficacy assessment period) 

The Audit Details Smart Compliance Professionals Look For 

Like most medical claims’ audits, the “devil is in the details”. To avoid problems, wise compliance professionals will: 

1. Monitor the most recent LCDs from their MAC 
2. Maintain a process to review the LCDs and implement processes to ensure compliance 
3. Perform records audits for both coding and medical necessity  

Some coders might have the requisite medical knowledge to audit for medical necessity. However, it usually requires a clinical background as well as an understanding of Medicare billing requirements such as LCDs. 

The regulatory compliance landscape around SI joint injections is dynamic and significant. It’s worth paying attention to those devilish details.  

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.   

Here are other resources to check out next: 

How to Avoid False Claims Related to Medical Necessity 

This expert blog gives compliance readers actionable steps to avoid civil monetary penalties and False Claims Act scrutiny resulting from documented medical necessity failures. 

Physician Coding and Billing Errors Enforcement: Compliance 

Get more context on enforcement actions stemming from unbundling, modifier misuse, and improper billing during same-day procedures. 

Know the Compliance Risk for Certain Anesthesia Services 

Learn about another recent OIG audit targeting spinal injection procedures and associated anesthesia/sedation coverage limitations. 

Medical Necessity: A Guide for Healthcare Compliance Leaders 

The linked article specifically discusses how MAC LCDs define medical necessity (such as requiring four weeks of conservative therapy prior to approving spinal injections)

The post Don’t Let Pain Injections Cause Regulatory Compliance Pain  first appeared on YouCompli.

About the Medical Necessity Series 

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

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

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

False Claims Act Metrics Make Significance Clear 

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

Case Involves SNF Reimbursement Dispute Over Therapy Services 

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

•  Physical therapy 
• Occupational therapy  
• Speech pathology services 

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

Whistleblower Lawsuit Triggers Investigation 

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

The five prongs of the alleged scheme were: 

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

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

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

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

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

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

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

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

This included: 

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

Widespread Occurrences Involve $14.6+ Billion in Alleged Intended Losses 

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

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

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

Three Takeaways from Medical Necessity Cases 

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

Key lessons from this case include: 

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

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

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

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

Apply These Takeaways to Your Own Regulatory Compliance Program 

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

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

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

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

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

Recent False Claims Act Complaint Hinges on Medical Necessity  

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

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

Three Ways Medical Necessity Impacts Performance 

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

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

1. Performance and Efficiency 

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

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

2. Financial and Compliance Risk 

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

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

3. Patient Outcomes and Quality 

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

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

Allege Longer Stays to Increase Medicare Reimbursement 

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

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

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

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

How Internal Concerns Become Full-Blown Investigations 

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

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

Manipulating Qualifying Patient Stays for Higher Reimbursement 

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

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

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

Ignored Alternatives Could Have Been Fraction of the Cost 

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

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

Compliance Responsible for Appropriate Processes 

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

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

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

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

Example of Inappropriate Intent to Maximize Revenue 

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

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

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

Requirements for Medical Necessity Determinations 

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

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

Learn from Examples of Medical Necessity Problems 

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

Find More Advice and Ideas in These Related Articles 

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

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

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

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.

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.   

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