Compliance

Published on: November 9, 2026

Is Medicare Opt-Out Right for Your Practice?

As Medicare reimbursement continues to decrease while the administrative burden of accepting Medicare only increases, many physician practices and other healthcare professionals are left wondering if there is a better, more efficient way to serve their patients. Add in Medicare’s endless regulatory changes, intrusive and poorly-conducted audits, and arbitrary enforcement actions, and a practice’s decision to take Medicare can quickly become more trouble than it is worth.

A possible solution may be to turn back the clock and return healthcare to a matter between the physician and the patient, without an insurance company or government agency intruding on that relationship and attempting to direct treatment through its power over reimbursement. While accepting payments directly from patients can avoid many of the obstacles presented by billing third-party payors, it is not a decision that should be taken lightly or haphazardly, especially where Medicare is involved.

In general, healthcare providers that furnish Medicare-covered items or services to Medicare-eligible patients are required to submit claims for those services to the Medicare program. A practice that charges cash to Medicare patients for Medicare-covered services may be in violation of federal law for doing so, unless the practice has “opted out” of Medicare. Medicare “opt out” is the process by which a physician or practitioner formally withdraws from participation in the Medicare program and establishes private contracts with patients to furnish items or services that would otherwise be covered by Medicare. The opt-out itself requires a specific regulatory filing, and the private contracts with patients are also required to meet certain criteria. Not all healthcare provider types have the ability to opt out, and once a provider opts out of Medicare, it can be difficult to undo or reverse the opt out.

Published on: October 19, 2026

Medicare Overpayments: When Does a Billing Error Become a False Claims Act Problem?

by Wachler & Associates, P.C.

Most healthcare providers understand that Medicare billing mistakes can result in repayment. The more difficult question is what happens when a provider discovers—or reasonably should discover—that it has been overpaid. That question matters because Medicare’s overpayment rules can intersect with the federal False Claims Act (FCA), creating consequences that extend well beyond repayment of an individual claim.

An overpayment is defined broadly as an amount paid to a provider that exceeds what was due and payable under applicable laws and regulations. Common alleged causes include incorrect coding, insufficient documentation, medical-necessity errors, and administrative or processing problems.

For Medicare Parts A and B providers and suppliers, the central rule is familiar: an identified overpayment generally must be reported and returned by the later of 60 days after identification or the applicable cost-report due date. Federal regulations also establish a six-year lookback period for identifying overpayments. The critical word is “identified.” Typically, an overpayment is identified when a provider has, or through reasonable diligence should have, determined that it received an overpayment and quantified the amount.

Published on: October 5, 2026

Incident-to Billing Under Medicare: A Compliance Trap for Otherwise Compliant Practices

by Wachler & Associates, P.C.

For many physician practices, “incident-to” billing can look like a straightforward way to structure care delivered by non-physician practitioners (NPPs). But the Medicare rules are more nuanced than simply having a physician somewhere in the practice. When the requirements are not satisfied, a practice can face claim denials, repayment demands, and potentially broader compliance concerns.

Under Medicare Part B, services furnished by certain NPPs may be billed as “incident to” a physician or other qualifying practitioner when specific requirements are met. In general, the services must be an integral part of the patient’s normal course of treatment, the physician or other practitioner must have personally performed the initial service and remain actively involved in the course of treatment, and the service must satisfy supervision and additional requirements.

One of the most important requirements is supervision. For traditional incident-to services, CMS requires direct supervision by a physician or other listed practitioner, meaning the supervising practitioner must meet the applicable supervision standard when the service is furnished. CMS also states that only the practitioner who provides the required supervision may bill the incident-to service. That requirement can create operational problems for otherwise well-run practices.

Published on: September 14, 2026

Medicare Denials as Compliance Intelligence: Turning Appeals Data Into a Risk-Management Tool

by Wachler & Associates, P.C.

For many healthcare organizations, a Medicare denial is treated as a financial nuisance: the claim was rejected, staff appeal it, and everyone moves on. That approach leaves valuable information on the table.

Medicare denials can function as an early-warning system for broader compliance problems. When analyzed systematically, denial data can help physicians and healthcare business leaders identify weaknesses in documentation, coding, medical necessity, utilization, training, and internal controls before those weaknesses become larger financial or regulatory problems. CMS uses multiple contractors and review programs to evaluate Medicare claims. Medical review contractors assess whether claims satisfy Medicare’s coverage, coding, payment, and billing requirements, and CMS explains that review activity may be driven by data analysis and identified vulnerabilities.

That same concept can be applied internally. Suppose a physician practice receives a handful of denials involving insufficient documentation. Viewed individually, each denial may seem routine. But if the same issue appears repeatedly across physicians, locations, or service lines, the organization may have identified a process problem rather than a collection of unrelated claim or documentation errors.

Published on: August 3, 2026

Medicare PPEO Audits

by Wachler & Associates, P.C.

Medicare-certified hospice providers are facing heightened regulatory oversight. In response to ongoing concerns about hospice compliance, as well as fraud, waste, and abuse within the hospice industry, both the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of Inspector General (“OIG”) have expanded their use of audits, investigations, and enforcement actions targeting hospice providers. Among these enforcement tools are Provisional Period of Enhanced Oversight (“PPEO”) audits, which apply to certain Medicare-enrolled hospice agencies. Providers should recognize that a PPEO audit can carry significant consequences, even where the perceived compliance issues appear relatively minor.

CMS introduced PPEO audits to address concerns surrounding hospice program integrity and regulatory compliance. Under the PPEO initiative, beginning in mid-2023, CMS has required audits of all “newly enrolled” hospice providers located in Arizona, California, Nevada, and Texas. Georgia and Ohio were added in late 2025. For purposes of the program, the term “newly enrolled” extends beyond providers entering the Medicare program for the first time. It also includes hospices that have undergone a Change of Ownership (“CHOW”), as defined by Medicare regulations, providers that have experienced a 100% ownership transfer, and agencies reactivating Medicare enrollment after a period of deactivation.

PPEO audits are sometimes likened to Targeted Probe and Educate (“TPE”) reviews because both processes may involve multiple rounds of claim review during which providers can receive feedback and, in some cases, an opportunity to correct identified deficiencies. That comparison, however, is limited, and in practice the two review processes differ substantially. TPE audits typically involve three rounds of review, and occasionally a fourth. CMS guidance requires the reviewing contractor to provide education to the provider and to allow time between review rounds so the provider can implement corrective measures and improve compliance. In addition, providers generally are not referred to CMS for administrative sanctions unless they fail three consecutive rounds of review by demonstrating persistently high error rates throughout the TPE process. Although TPE audits can ultimately result in revocation of Medicare billing privileges, that outcome generally occurs only after repeated unsuccessful review cycles.

Published on: July 7, 2026

OIG Focusing on Clinical Laboratories

by Wachler & Associates, P.C.

The HHS Office of Inspector General (OIG) recently updated its work plan to announce two new initiatives directed towards clinical laboratories billing Medicare for laboratory tests. The OIG work plan includes the various projects, audits, evaluations, and reviews that OIG is planning or that are currently underway. Medicare providers often experience the downstream effects of OIG projects or are directly the subject of OIG projects, and should therefore be aware of OIG’s enforcement priorities.

First, OIG intends to review trends and vulnerabilities in genetic tests covered under Medicare Part B. OIG noted the steady increase in Medicare expenditures on genetic tests, as well as the higher average per-test payment amount of these tests when compared to other laboratory tests under Part B. OIG asserted that it had identified genetic testing fraud schemes involving deceptive telemarketing campaigns and kickbacks. Pursuant to this project, OIG will examine avenues for strengthening oversight of genetic tests covered under Part B, including identifying tests that may be vulnerable to fraud, waste, and abuse; assessing trends among laboratory test providers; and examining whether geographic variations exist, particularly between jurisdictions that do and do not participate in the Molecular Diagnostic Services Program.

Second, OIG intends to review Medicare payments to providers for some expanded laboratory panels. OIG noted that expanded panels (those that can detect six or more pathogens) result in higher Medicare payments than targeted panels (those that can detect up to five pathogens). OIG stated it has concerns that providers have been administering expanded laboratory panels when targeted laboratory panels would be sufficient, resulting in significantly higher Medicare payments to those providers. OIG intends to determine whether Medicare has paid providers for some selected expanded panels that are not medically necessary, do not meet Local Coverage Determination (LCD) requirements, or otherwise do not meet Medicare requirements.

Published on: January 15, 2026

Continued Extension of Telemedicine Controlled Substance Prescribing Through 2026

by Wachler & Associates, P.C.

On December 31, 2025, the Drug Enforcement Administration (DEA) released a fourth temporary rule extending certain controlled substance prescribing flexibilities through December 31, 2026. The Rule creates an exception to the 2008 Ryan Haight Act, which requires providers to conduct an in-person examination before prescribing Schedule II–V controlled substances. This temporary rule immediately follows a November 2024 extension that expired on December 31, 2025. The extension of telehealth flexibilities, which policymakers originally invoked in response to the COVID-19 public health emergency, prevents an abrupt end to telehealth services for providers and patients. The Rule allows patients in rural and underserved communities, the elderly, and patients with mobility challenges to maintain continuous, uninterrupted access to care and necessary controlled medications without an in-person visit.

Regulators have taken several steps to make portions of the telehealth flexibilities permanent. In March 2023, the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued two notices of proposed rulemaking: “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation” and “Expansion of Induction of Buprenorphine via Telemedicine Encounter.” Together, these notices generated more than 38,000 comments, many of which recommended varying degrees of change.

On January 17, 2025, the DEA published the “Special Registrations for Telemedicine and Limited State Telemedicine Registrations” Notice of Proposed Rulemaking, which proposed a framework for a Special Registration for Telemedicine. Under this proposal, providers who continue to prescribe controlled medications without an initial in-person evaluation would need to comply with additional registration, reporting, and recordkeeping requirements. The DEA received an additional 6,000 comments in response.

Published on: December 4, 2025

Understanding Medicare Revocations: Key Considerations for Providers and Suppliers

by Wachler & Associates, P.C.

Medicare participation offers essential opportunities for providers and suppliers, but it also comes with a framework of regulatory responsibilities and administrative risks. One area that continues to generate questions, as well as significant operational impacts, is Medicare enrollment revocation. While most organizations are familiar with the concept in broad terms, the underlying causes, processes, and potential consequences remain complex. A clearer understanding of the general landscape can help healthcare providers and suppliers maintain compliance and reduce unexpected disruptions.

At its core, a Medicare revocation occurs when the Centers for Medicare & Medicaid Services (CMS) removes a provider or supplier’s enrollment and billing privileges. This action typically arises from situations indicating noncompliance with program requirements or the appearance thereof. In some cases, these may relate to issues such as improper reporting, operational concerns, or other regulatory or medical review findings that signal a need for CMS to reassess a provider’s or supplier’s continued participation. In other cases, a provider’s failure to respond to medical records requests or errors by a contractor can give rise to the appearance that the provider had engaged in conduct that would warrant a revocation.

The revocation process generally begins when CMS or a Medicare Administrative Contractor (MAC) identifies a potential issue. Providers and suppliers are notified in writing and given information about the basis for the action. Although the communication outlines key details, the language can often feel broad or vague, particularly because revocation authorities cover a wide range of scenarios. Regardless of the particular circumstances, receiving a revocation notice should prompt immediate attention and internal review.

Published on: December 2, 2025

Understanding CMS’ New WISeR Program

by Wachler & Associates, P.C.

In a move aimed at addressing the persistent challenge of high healthcare spending, the Centers for Medicare & Medicaid Services (CMS) recently launched a new payment and oversight model called WISeR, short for “Wasteful and Inappropriate Service Reduction.” Set to begin in January 2026 and run through 2031, WISeR is designed to use artificial intelligence (AI) to identify and reduce the provision of services that Medicare deems unnecessary, duplicative, or low value. While its goals are familiar, the model marks a shift in how CMS is approaching prior authorization, technology use, and provider oversight.

For healthcare providers, WISeR represents both a policy change and a shift in operational workflow, especially for those practicing in the six participating states: Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington. Although the model is technically focused on a limited number of outpatient services, including certain spinal procedures, wound care treatments, and pain management interventions, its implications could be far-reaching.

WISeR does not alter Medicare’s coverage or payment rules. Instead, it changes the process through which specific services are reviewed before payment is made. Providers in participating states will face two main options: they can submit prior authorization requests through CMS-approved technology vendors or have claims for selected services reviewed through a more rigorous prepayment review process.

Published on: November 25, 2025

Navigating Medicare Claims Audits: A Strategic Guide for Providers

by Wachler & Associates, P.C.

For healthcare providers participating in the Medicare program, facing a claims audit can be both challenging and time-consuming. Denials are common during these audits, and when they occur, the appeals process can stretch over months or even years. Each step requires careful strategy and timely action.

Typically, a Medicare audit is initiated when a Medicare contractor requests medical records from a provider. At this early stage, it’s crucial to understand the context of the request. Identifying the type of contractor involved, whether it’s a Medicare Administrative Contractor (MAC), Unified Program Integrity Contractor (UPIC), Recovery Audit Contractor (RAC), or Supplemental Medical Review Contractor (SMRC), can provide important insight into what kind of review is being conducted. The nature of the review itself also matters: is it a pre-payment or post-payment audit? Is it part of a Targeted Probe and Educate (TPE) program, a Comprehensive Error Rate Testing (CERT) audit, or a Potential Payment Error Opportunity (PPEO) initiative? Is there a likelihood that the audit includes statistical extrapolation?

The provider’s own history and operational context can also affect the review. For instance, has the provider faced similar audits recently? Was there a recent ownership transfer? Are any necessary records held by another entity? These details may guide the provider’s next steps. Depending on the scope and risk level of the audit, providers might take proactive measures to support their claims. This could include submitting additional documentation, hiring a clinical reviewer to evaluate the claims, engaging directly with the contractor, or preparing a detailed legal response. In other situations, simply submitting the requested records and awaiting a decision may be the most prudent course.