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Erica Kraus is a partner in the Corporate Practice Group in the firm's Washington, D.C. office.

As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation often includes a combination of a base salary with a variable bonus component tied to performance metrics, with the metrics being chosen based on overarching organizational goals, such as improving quality of care and managing costs. With these aims in mind, hospitals and health systems often base bonus achievement on meeting certain objective metrics, such as patient satisfaction scores, productivity measures, adherence to clinical guidelines, cost-saving measures, or other quality indicators most applicable to the department or physician group involved.Continue Reading Navigating Gainsharing Pitfalls in Value-Based Models

With only two weeks remaining in the year, Congress is considering a government funding deal (the “Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025” or the “Bill”) that includes a welcome holiday gift for health care providers and patients – an expansive health care package that would extend certain telehealth flexibilities promulgated during the COVID-19 public health emergency (“PHE”) for an additional two years. The extended telehealth flexibilities are currently set to expire on December 31, 2024. This extension would generally allow providers to continue to serve Medicare patients via telehealth consistent with the current practices.Continue Reading Congress Extends Telehealth Flexibilities for Two More Years

Yesterday, the OIG released a Special Fraud Alert related to: (1) marketing arrangements between Medicare Advantage Organizations (“MAOs”) and health care professionals (“HCPs”), and (2) arrangements between HCPs and MA plan agents and brokers. In the Alert, OIG states that these types of arrangements may implicate the Federal anti-kickback statute (the “AKS”) and could result in unfair competition and improper steering of Medicare beneficiaries. Despite flagging these concerns, the Alert fails to offer specific, practical guidance on the types of arrangements that would or would not violate the law, and therefore does little to alleviate industry-wide confusion as to how to compliantly engage in beneficiary outreach and support.Continue Reading Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable by Medicare. Although the majority of telehealth waivers enacted during the COVID-19 public health emergency (the “PHE”) are set to expire at the end of 2024 in the absence of legislative action, CMS has proposed to leave certain key flexibilities in place, including the allowance for physicians and other practitioners to furnish remote “direct supervision” through their immediate availability via audio-video technology.Continue Reading Key Telehealth Updates in the CY 2025 Physician Fee Schedule Proposed Rule

Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed payments set by Medicare, as well as, in some cases, significant additional payments from health plans. Concerned over the potential for abuse, these arrangements have been the subject of Congressional scrutiny and an enforcement priority for both the Department of Justice (“DOJ”) and the Department of Health and Human Services Office of the Inspector General (“HHS OIG”). The Biden Administration and the Centers for Medicare & Medicaid Services (“CMS”) are tackling this issue head-on in a recently published final rule that addresses both marketing tactics and compensation methodologies used by Medicare Advantage organizations (“MAOs”) to pay MA agents or brokers.[1]Continue Reading Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space

Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the bona fide employee exception and safe harbor to the federal Anti-Kickback Statute (the “AKS”). The opinion highlights flexibility for healthcare providers seeking to compensate employees in ways that align incentives with their employers, and particularly for physician practices to align employed physicians with use of the practices’ ambulatory surgery center (“ASC”) capabilities.Continue Reading OIG Confirms the Broad Protection of Employee Safe Harbor

On February 13, 2023, the Centers for Medicare and Medicaid Services (CMS) published the revised List of Telehealth Services for Calendar Year (CY) 2023 (List). The List includes the services that are payable under the Medicare Physician Fee Schedule when furnished via telehealth.Continue Reading CMS Updates List of Telehealth Services for CY 2023

On August 19, the Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable advisory opinion, AO 22-16, with respect to the provision of gift cards to Medicare Advantage (“MA”) plan enrollees who complete certain steps in an online patient education program. This opinion underscores potential flexibility for with Medicare Advantage Organizations (“MAOs”) and their vendor partners to offer incentives to patients to engage in learning and health care engagement activities that may improve health outcomes without inappropriately steering patients toward particular providers or MA plans.Continue Reading OIG Blesses Gift Cards for Patient Engagement with Education Tool

On June 24, 2022, the United States Supreme Court issued its opinion on Dobbs v. Jackson Women’s Health Organization, No. 19-1392 (2022), holding that the United States Constitution provides no basis for a right to abortion. In its opinion, the Court further states that the right to abortion is not in the text of the Constitution, not a part of this nation’s fundamental history or concept of ordered liberty, that abortion restrictions are subject to rational basis review, and that the authority to regulate abortions lies with the 50 individual states. This decision, which is consistent with the draft opinion leaked in May, overrules both Roe v. Wade (1973) and Planned Parenthood v. Casey (1992), which have served as precedent on abortion issues and rights for the past 50 years.Continue Reading Supreme Court Decision in Dobbs v. Jackson Women’s Health Organization Overturns 50 Years of Precedent on Abortion Laws and Rights

Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here. EKRA prohibits, among other things, the exchange of remuneration for referrals of patients or patronage to a clinical laboratory, or an individual’s use of the services of a clinical laboratory. The law, however, leaves key terms undefined, including “referral”, “patronage”, and “use of services.” This ambiguity leaves unclear exactly which forms of conduct are prohibited by EKRA. Further, EKRA contains exceptions that overlap imperfectly with safe harbors under the Anti-Kickback Statute (AKS) and states, confusingly, that EKRA “shall not apply to conduct that is prohibited” by the AKS. The latter provision imperils the status of conduct that is within an AKS safe harbor, but which does not meet the requirements of an EKRA exception. No implementing regulations have been published to alleviate any of these ambiguities.Continue Reading California District Court Finds that EKRA Applies to Compensation Methodologies for Labs’ Employed Marketers Who Market to Physicians