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Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to health care organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Read Monica A. Wallace's full bio.

New Guidance on Medicare Payment Rule Enforcement


By , , , and on Dec 5, 2019
Posted In Other Notable Enforcement Actions

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and Medicaid Services (CMS). The memo expressed OGC’s views on the impact of the Supreme Court’s Azar v. Allina Health Services, et. al., No....

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Stark Law Proposed Change Affects Group Practice Special Rules for Productivity Bonuses, Profit Shares


By , , , , , and on Oct 22, 2019
Posted In Stark

On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to the Stark Law, and the proposed rule includes an important clarification affecting certain group practices’ compensation models. CMS proposes to revise...

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HHS Proposes Substantial Changes to the Stark Law and the Anti-Kickback Statute Regulations


By , , , , and on Oct 9, 2019
Posted In Anti-Kickback Statute / Stark Law, Stark

On October 9, 2019, the US Department of Health and Human Services (HHS) published proposed changes to the physician self-referral law (Stark Law) (Stark Proposed Rule) and the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Civil Monetary Penalty Law (CMPL) (AKS Proposed Rule). The proposed rules represent some of the most significant potential changes to...

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OIG Seeks Comments on Anti-Kickback Statute and Beneficiary Inducements as Part of its Regulatory Sprint to Coordinated Care


By , , , , , and on Aug 27, 2018
Posted In Anti-Kickback Statute / Stark Law, Compliance Developments

On August 24, 2018, the Office of Inspector General (OIG), Department of Health and Human Services (HHS) published a request for information, seeking input from the public on potential new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement prohibition in the Civil Monetary Penalty (CMP) Law to remove impediments to care...

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Health Care Enforcement Quarterly Roundup | Q2 | July 2018


By , , , , , , , , , , , , and on Jul 18, 2018
Posted In Compliance Developments, Other Notable Enforcement Actions

How will key trends and developments in health care policy and enforcement impact future litigants? In the latest Health Care Enforcement Quarterly Roundup, we address this question in the context of: Continued interpretations of the landmark Escobar case The latest guidance from US Department of Justice (DOJ) leadership regarding enforcement priorities The uptick in state...

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CMS Seeks Comments on Stark Law Reforms Needed to Reduce Obstacles to Innovation


By , , , , , and on Jul 3, 2018
Posted In Stark

On June 25, 2018, the Centers for Medicare and Medicaid Services (CMS) published a request for information, seeking input from the public on how to address any undue regulatory impact and burden of the physician self-referral law (Stark Law) on value-based and other coordinated care arrangements designed to improve quality and lower cost. While the...

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OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements


By , , and on Dec 14, 2016
Posted In Anti-Kickback Statute / Stark Law

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary inducement prohibition in the civil monetary penalty rules. Effective January 6, 2017, the Final Rule modifies certain existing safe harbors...

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‘Tis the Season for Giving: OIG Updates Policy on Gifts of Nominal Value to Medicare and Medicaid Beneficiaries


By , , and on Dec 12, 2016
Posted In Anti-Kickback Statute / Stark Law

On December 7, 2016, the Office of the Inspector General (OIG) of the US Department of Health and Human Services (HHS) issued a policy statement increasing its thresholds for gifts that are considered “nominal” for purposes of the patient inducement provisions of the civil monetary penalties law (section 1128A(a)(5) of the Social Security Act) (CMP...

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Old Dog, New Tricks: Fraud and Abuse in the Age of Payment Reform


By and on Nov 1, 2016
Posted In Anti-Kickback Statute / Stark Law, Stark, State Law Claims

The good, reassuring news about that “old dog” fraud and abuse as it enters an age of payment reform is that criminal liability for fraud still requires a specific intent to defraud the federal health care programs, anti-kickback liability still requires actual knowledge of at least the wrongfulness, if not the illegality, of the financial...

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