Daniel H. Melvin
Subscribe to Daniel H. Melvin's PostsDaniel H. Melvin counsels clients on Stark, Anti-Kickback and Medicare compliance issues such as physician compensation matters, and assists clients in investigating and addressing potential or alleged violations, including self-disclosures and defense of Stark- and Anti-Kickback-related qui tam actions. He also works with hospitals and physicians on coordinated care and other alternative service delivery models, including bundled payment and cost savings models, providing regulatory and transactional counsel and support. Read Daniel H. Melvin's full bio.
Stark Law Proposed Change Affects Group Practice Special Rules for Productivity Bonuses, Profit Shares
By Chelsea M. Rutherford, Dana Dombey, Daniel H. Melvin, James A. Cannatti III, Monica Wallace, Nicholas Alarif and Tony Maida 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 Daniel H. Melvin, James A. Cannatti III, Joan Polacheck, Monica Wallace, Nicholas Alarif and Tony Maida 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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Third Circuit Perpetuates Tuomey’s Controversial Stark Law “Volume or Value” Standard
By Daniel H. Melvin, Joan Polacheck, Laura McLane and Tony Maida on Oct 2, 2019
Posted In Anti-Kickback Statute / Stark Law
In U.S. ex rel. J. William Bookwalter, III, M.D. et al. v. UPMC et al., the US Court of Appeals for the Third Circuit endorsed two controversial interpretations of the Stark Law’s “volume or value” standard, known as the correlation theory and the practice “loss” theory. Specifically, the court held that the relators had made out...
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OIG Seeks Comments on Anti-Kickback Statute and Beneficiary Inducements as Part of its Regulatory Sprint to Coordinated Care
By Amy H. Kearbey, Daniel H. Melvin, Eric B. Gordon, MD, Jason B. Caron, Joan Polacheck, Monica Wallace and Tony Maida 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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CMS Seeks Comments on Stark Law Reforms Needed to Reduce Obstacles to Innovation
By Amy H. Kearbey, Daniel H. Melvin, Eric B. Gordon, MD, Joan Polacheck, Kelsey Leingang, Monica Wallace and Tony Maida 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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Is the Stark Law’s “Signed Writing” Requirement Material to Payment: One Federal Court Says Yes
By Daniel H. Melvin, Joshua T. Buchman, Joan Polacheck, Rebecca Waltuch and Tony Maida on May 10, 2017
Posted In Anti-Kickback Statute / Stark Law, Knowledge/Scienter, Materiality, Stark
In a case of first impression, a federal court found that the federal physician self-referral law’s (Stark Law) requirement that financial arrangements with physicians be memorialized in a signed writing could be material to the government’s payment decision. This case raises troubling questions about applying the False Claims Act (FCA) to what many in the...
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CMS Reissues Stark Rules Restricting Certain Unit-based Rental Rate Arrangements and Issues Two Stark Updates
By Amanda Enyeart and Daniel H. Melvin on Nov 16, 2016
Posted In Anti-Kickback Statute / Stark Law, Stark
On November 15, 2016, as part of its 2017 Medicare Physician Fee Schedule update, the Center for Medicare and Medicaid Services reissued its prohibition on certain unit-based rental arrangements with referring physicians, adopted updates to the list of CPT/HCPCS codes defining certain of the Stark Law’s designated health services and implemented a minor technical change...
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Old Dog, New Tricks: Fraud and Abuse in the Age of Payment Reform
By Daniel H. Melvin and Monica Wallace 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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Congress Examining Stark Law Reform This Year
By Amanda Enyeart, Daniel H. Melvin and Eric B. Gordon, MD on Jul 19, 2016
Posted In Anti-Kickback Statute / Stark Law, Government investigation, Stark
On July 12, 2016, the US Senate Finance Committee held a hearing to “examine ways to improve and reform the Stark Law” as a follow up to releasing a white paper on June 30 titled Why Stark, Why Now? Suggestions to Improve the Stark Law to Encourage Innovative Payment Models. The white paper summarizes comments...
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Health System Practice ‘Losses’ Make Headlines, Plaintiffs Make New Stark ‘Law’
By Daniel H. Melvin and Eric B. Gordon, MD on Nov 25, 2015
Posted In Stark
Health systems routinely employ physicians, either directly or through corporate affiliates. Media reports and anecdotal evidence suggest such practices routinely, perhaps uniformly, result in net practices losses for the system when measured solely based on physician practice revenues. Does this fact have any legal import under the Stark Law? Read the full article from Bloomberg BNA...
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