Articles Posted in Fraud & Abuse

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently updated its Work Plan, adding several new audits and reviews. The OIG Work Plan forecasts the projects that the OIG plans to implement over the foreseeable future. These new initiatives are a signal of which areas the OIG views as warranting heightened scrutiny,  and providers in these areas should take note of the OIG’s actions.

One of the most notable projects on the OIG Work Plan focuses on auditing Medicare claim lines for which the payment exceeds the actual charge. CMS contracts with various Medicare Administrative Contractors (MACs) to, among other things, process and pay claims submitted by providers for items and services covered under Medicare Part B. Generally, Part B payments are based on a fee schedule, prospective payment system, or some other method, rather than a cost or charge basis. In most cases, a healthcare provider’s billed charges exceed the amount that Medicare pays for Part B items and services. Under this Work Plan item, the OIG is focused on Medicare payments that exceed the billed charges, which can be overpayments. Providers should keep a close watch on their Medicare remittance advices or explanation of benefits to be aware of any payments that exceed the corresponding billed charge.

In terms of specific healthcare services, the OIG is turning its attention to hyaluronic acid injections, commonly used to treat knee osteoarthritis. While these injections are widely used for joint pain, there are ongoing questions about whether they are worth the cost and being used appropriately. The OIG’s audit will review Medicare reimbursements for these treatments and whether providers are following proper billing procedures.

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Simply put, Medicare rarely audits dentists because Medicare generally does not cover or pay for dentistry. However, doctors of dental surgery and doctors of dental medicine may perform far more complex surgical procedures than the examinations, cleanings, and fillings that are in the common perception of what a dentist does. Where Medicare does cover and subsequently audits services provided by dentists, the issues raised are generally complex and nuanced. Dentists who bill Medicare should be familiar with the Medicare claims appeal process and some of the issues specific to Medicare coverage of dental services.

The Medicare claims appeal process is a lengthy and complex 5-step process. After the provider receives a determination of claim denials and demand to repay an alleged overpayment, the first appeal step is Redetermination, often before the same Medicare contractor that issues the initial claim denials. Second is Reconsideration before a different Medicare contractor. Third is review by an Administrative Law Judge (ALJ), which may include a hearing – often telephonic – where the provider can present evidence and testimony. Fourth is appeal to the Medicare Appeal Council, the highest adjudicatory body within the Department of Health and Human Services. Fifth is appeal to federal court, which is often limited in scope and may not be appropriate in every case. It can take several months, if not years, for a case to fully work its way through the Medicare claims appeal process, depending on the circumstances.

Medicare audits of services provided by dentists nearly always involve the “dental services exclusion.” By law, the Medicare program does not cover services performed in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting the teeth, which is generally considered to include the periodontium. Procedures on other parts of the mandible or maxilla may be covered where they are medically necessary and meet other coverage criteria. Because of the key distinction between procedures in connection with the teeth and structures directly supporting the teeth, dentists who bill Medicare may consider how they document procedures to clearly document procedures which may not be subject to the coverage exclusion. Procedures on the teeth and periodontium may also be covered where they are inextricably linked to a primary covered service. Further, Medicare contractors may mistakenly interpret the statutory coverage exclusion to mean that Medicare never covers any services provided by a dentist, simply because they are performed by a dentist. However, this assertion is generally inconsistent with the Social Security Act and Medicare guidance.

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On July 31, 2024, the Centers for Medicare & Medicaid Services (CMS) published the Calendar Year 2025 Physician Fee Schedule (PFS) Proposed Rule. Among other changes, the 2025 PFS Proposed Rule includes additional proposed changes to the so-called “60-day rule” regarding returning identified overpayments. Initially established by the 2010 Affordable Care Act, the 60-day rule requires healthcare providers to report and return Medicare and Medicaid overpayments within 60 days of identifying such overpayments. The potential consequences for failing to comply with the 60-day rule are severe, and can result in the imposition of a civil monetary penalty or an alleged violation of the Federal False Claims Act. Providers should pay close attention to the potential changes to the 60-day rule included in the 2025 PFS Proposed Rule.

The 2025 PFS Proposed Rule is not the first time that CMS has proposed changes to the 60-day rule, and it likely will not be the last. In December 2022, CMS published a proposed rule that would amend the regulations regarding the standard for an “identified overpayment” under the Medicare program. Specifically, the December 2022 Overpayment Proposed Rule proposed to remove the existing “reasonable diligence” standard and adopt by reference the Federal False Claims Act definition of “knowing” and “knowingly.” To date, CMS has not finalized these proposals with respect to identified overpayments under the Medicare program.

In the 2025 PFS Proposed Rule, CMS states that it is retaining the proposals published in the December 2022 Overpayment Proposed Rule, and proposes further changes to revise the regulations regarding the timeframe for reporting and returning overpayments. Currently, the applicable regulations require that an overpayment be reported and returned by the later of:  (1) the date which is 60 days after the date on which the overpayment was identified; or (2) the date any corresponding cost report is due, if applicable. However, under the 2025 PFS Proposed Rule, the deadline for returning a reported overpayment would be suspended under specified circumstances. The 2025 PFS Proposed Rule would create an entirely new regulatory provision to suspend the deadline for reporting and returning overpayments for up to 6 months to allow time for providers to investigate and calculate overpayments. Previously, in 2016 rulemaking regarding reporting and returning of overpayments, CMS discussed that under the “reasonable diligence” standard, providers would be allowed a 6-month period in which to conduct a good-faith investigation of credible information of a potential overpayment. At the time of the 2016 rulemaking, CMS had not proposed to implement this 6-month period into the applicable regulations.

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The US Department of Justice (DOJ) recently filed its first criminal drug distribution prosecutions related to telemedicine prescribing through a digital health company.  The indictments accused Done Global, Inc., its founder and CEO, its clinical president, and several other persons associated with the company of participating in a scheme to distribute Adderall over the internet, conspire to commit health care fraud in connection with the submission of false and fraudulent claims for reimbursement for Adderall and other stimulants, and obstruct justice. This case is highly instructive for those seeking to structure both telemedicine arrangements and payment arrangements with healthcare providers.

Specifically, DOJ alleged that Done operated a business model wherein it charged monthly subscription fees to patients and facilitated telemedicine visits with prescribers for the treatment of ADHD, including prescribing Adderall. DOJ alleged that the business model limited the information available to prescribers, instructed Done prescribers to prescribe Adderall and other stimulants even if the patient did not qualify, mandated that initial encounters would be under 30 minutes, included an auto-refill function that allowed patients to automatically request a refill each month, did not compensate prescribers for follow-up visits or consults after the initial consults, and compensated prescribers solely based on the number of patients who received prescriptions. DOJ alleged that these practices led to false and fraudulent claims for medically unnecessary services being submitted to Medicare, Medicaid, and commercial insurers.

In addition to allegations regarding the business model, DOJ also alleged that the company had been made aware that material was posted on online social networks about how to use Done to obtain easy access to Adderall and other stimulants, but that Done allegedly sought to conceal this information and made fraudulent statements to the media regarding it. The indictments of the individual officers of the corporation are also consistent with federal law enforcement’s emphasis on holding individuals, rather than just the corporation, responsible for alleged healthcare fraud.

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Private equity (PE) and venture capital firms have been expending their involvement and acquisitions in the healthcare industry for years. Many physicians, physician practices, other healthcare provider types, or their employees who are approached by PE regarding an acquisition may have questions regarding the proposed deal or some of the issues that may arise.

In general, a PE firm will approach a physician practice or other provider type and propose some sort of arrangement. The PE firm may seek to buy a controlling interest in the practice, where state law allows non-physician ownership of a practice, or to set up a management services organization which contracts with and manages the practice. Either way, the PE firm acquires control over most or all of the operations of the practice. The PE firm may persuade the practice to enter the arrangement with promises that the PE firm will provide some form of management expertise, industry experience, or unique support structures that will make the practice more profitable or efficient.

However, most, though not all, PE firms adhere to a business model that prioritizes short-term profitability over other concerns. This model may conflict with the priorities of physicians who also prioritize quality of patient care, sustainment of professional and business relationships, and the long-term viability of a practice. In practice, PE firms often attempt to cut costs by decreasing administrative or clinical support staff, increasing physician workload, renegotiating contractual agreements with the practice’s vendors and employed physicians, or shifting the practice’s business model toward more profitable services and cutting less profitable patient services. While some of these measures may very well increase the efficiency of a practice, physicians should be aware that their priorities may not align with the priorities of the PE firm seeking to take over the practice. Physicians should carefully evaluate the terms and operative models of any such transaction with a PE firm or PE-back entity.

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently announced that it intends to increase scrutiny of fee-for-service peripheral vascular procedures billed to the Medicare program. Although OIG did not describe the specific actions in intends to take, it appears likely that OIG will conduct data analysis of Medicare claims for vascular services, especially atherectomies and angioplasties; conduct audits of specific providers, likely those with high utilization of vascular services or those with prior audit denials or accusations of improper billing; and also review the program integrity measures that CMS and its contractors have taken to address fraud, waste, and abuse in these procedures.

In explaining the motivation for its review, OIG noted that the use of peripheral vascular procedures in the Medicare population has increased over the past decade. In 2022, Medicare paid more than $600 million for atherectomies and angioplasties with and without a stent in peripheral arteries. These minimally invasive surgeries aim to improve blood flow when arteries narrow or become blocked because of peripheral arterial disease but are recommended only after patients have tried medical and exercise therapy, and have lifestyle-limiting symptoms. OIG also asserted that CMS and whistleblower fraud investigations have identified these surgeries as vulnerable to improper payments.

Our firm has significant experience in representing physician groups and other providers in the defense of Medicare audits of vascular procedures. We have seen many instances in which Medicare contractors have misunderstood clinical terminology or other documentation elements relating to vascular procedures and have inappropriately denied claims or even alleged that the provider has committed fraud based only on the contractor’s own mistaken interpretation of the provider’s medical records. Providers who are audited by the Unified Program Integrity Contractors (UPICs), such as CoventBridge Group, should be particularly vigilant in reviewing any findings or claim denials issued by the UPICs. Such denials are generally appealable through the Medicare claims appeal process and may be partially or fully overturned on appeal. Even where a provider prevails on appeal, a contractor’s spurious fraud allegations can have significant detrimental impacts, including delays in payment, Medicare payment suspensions, and further audits from both Medicare and other payors.

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On April 26, 2024, the Department of Health and Human Services (HHS) published a Final Rule introducing compliance changes for reproductive healthcare information under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Titled “HIPAA Privacy Rule to Support Reproductive Health Care Privacy,” the Final Rule prohibits disclosure of protected health information (PHI) related to lawful reproductive healthcare under certain circumstances. HIPAA-covered entities will also be required to update their Notices of Privacy Practices (NPPs), obtain attestations in connection with certain requests for reproductive healthcare information, and update their HIPAA policies and training.

The Final Rule prohibits uses or disclosure of PHI to investigate or impose liability on individuals, healthcare providers, or others who seek, obtain, provide, or facilitate reproductive healthcare that is lawful under the circumstances under which it is provided, or to identify persons for such activities. Notably, the Final Rule includes a presumption, with certain exceptions, that the reproductive healthcare provided by a person other than the covered entity receiving the request was lawful. Covered entities are required to obtain a signed attestation from certain requestors that they do not seek PHI for these prohibited purposes. This requirement applies when PHI is requested for health oversight activities, judicial and administrative proceedings, law enforcement purposes, and disclosure to coroners and medical examiners. The HHS Office for Civil Rights (OCR) has stated that it intends to publish model attestation language. Additionally, covered entities are required to modify their NPPs to support reproductive healthcare privacy.

The Final Rule continues to allow covered healthcare providers to use or disclose PHI for purposes otherwise permitted under the Privacy Rule where the request for the use or disclosure of PHI is not made to investigate or impose liability on any person for the mere act of seeking, obtaining, providing, or facilitating reproductive healthcare. The Final Rule will become effective on June 25, 2024, with a compliance date of December 23, 2024, except for certain requirements pertaining to Notices of Privacy Practices. Covered entities must comply with the NPP provisions of the Final Rule by February 16, 2026.

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On March 12, 2024, several senators wrote a letter to the Government Accountability Office (GAO) Comptroller General, requesting an investigation into the policies and procedures CMS has in place to prevent Medicare fraud, waste, and abuse. The senators noted that in 2022, GAO estimated there were $47 billion in improper Medicare payments with $1.7 billion being reclaimed, representing a 2.8% recovery rate.

The senators’ letter was likely prompted by a recent investigation from the National Association of Accountable Care Organizations (NAACOS), which uncovered an alleged fraudulent urinary catheter scheme. NAACOS discovered that ten medical device companies went from billing 15 patients for catheters to over 500,000 patients for catheters within a period of two years. This alleged scheme has been estimated to cost CMS over $2 billion and has garnered significant media attention. Of particular concern to the senators is the fact that NAACOS publicly commented on this issue prior to any announcements from CMS.

The senators noted that this alleged scheme highlights “critical vulnerabilities” within CMS’ fraud, waste, and abuse policies. To this point, they requested that the fraud prevention measures of the Medicare Fraud Strike Force, a team with representatives from the Department of Health and Human Services (HHS), Office of Inspector General (OIG), and Federal Bureau of Investigation (FBI), should be investigated by GAO in order to identify weaknesses and areas for improvement.

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As we noted previously, Medicare providers of wound care services continue to be the target of audits by Medicare contractors. Wound care services typically involve the application of allografts, skin substitutes, and related products to promote healing and support recovery. Due to the generally high reimbursement rates and need for frequent reapplication of these types of products, the Medicare program views such products as a high risk for improper payments or alleged fraud. Providers who utilize these products for wound care services or who are subjected to audit should understand the contours of an audit and be aware of their rights in responding to an audit.

The Medicare Unified Program Integrity Contractors (UPICs), such as the CoventBridge Group or Qlarant, typically perform these audits. UPICs are charged with the primary goal of investigating instances of suspected fraud, waste, and abuse in Medicare or Medicaid claims. Historically, UPICs are quick to allege that a provider has committed fraud and deny claims for any supposed non-compliance with coverage or documentation requirements, regardless of how minor the perceived deficiency. Providers should be cognizant that a UPIC’s allegation of fraud or non-compliance may bring about significant adverse consequences, especially when such allegations are not disputed. These allegations may be addressed by a timely and well-developed appeal of claims denied by the UPIC.

Wound care services involving skin substitutes and similar products subject to audit are generally denied for reasons such as the following:

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A recent report by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) may signal even more scrutiny of healthcare providers who received funds from the Provider Relief Fund (PRF). As we have long predicted, while the PRF was intended as a financial lifeline for the country’s healthcare providers during the height of the COVID-19 pandemic, as the pandemic has cooled, it has become a minefield of compliance issues for healthcare providers and fertile ground for government auditors to demand repayments.

The PRF is a $178 billion fund created by Congress through the CARES Act to provide financial relief to healthcare providers during the COVID-19 pandemic. HHS subdivided the PRF into various general and targeted distributions and assigned the Health Resources and Services Administration (HRSA) to administer the PRF. These distributions were paid to providers in several waves between April 2020 and the present. While this infusion of cash was likely a welcome relief at the time, it came with strings attached. Some of these strings included restrictions on which providers were eligible to receive funds, restrictions on how providers could use the funds, and requirements to report on the use of the funds.

The recent OIG investigation looked at PRF payments made to 150 providers during the PRF Phase 2 General Distributions. The Phase 2 General Distributions required providers to apply for payments and submit documentation. HRSA reviewed these applications and calculated the payment amount to make to provider, mostly based on the provider’s patient care revenue as documented in the application. OIG asserted that, for 17 of the 150 providers it reviewed, HRSA had miscalculated amounts due and had overpaid the providers. OIG recommended that HRSA demand these providers return these funds and that HRSA review all other Phase 2 General Distributions for similar errors HRSA may have made.

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