Joan Polacheck Joan Polacheck

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Joan Polacheck advises clients on a variety of health care compliance and regulatory issues, including fraud and abuse, Stark law, Anti-Kickback Law and Medicare reimbursement issues. She represents a broad range of health care industry clients, including hospitals, suppliers, and drug and device companies. Read Joan Polacheck's full bio.

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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Third Circuit Perpetuates Tuomey’s Controversial Stark Law “Volume or Value” Standard


By , , and 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 , , , , , 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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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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False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors


By , and on Jun 9, 2017
Posted In Anti-Kickback Statute / Stark Law, Corporate Integrity Agreements

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments...

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Is the Stark Law’s “Signed Writing” Requirement Material to Payment: One Federal Court Says Yes


By , , , and 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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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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CMS Proposes Stark Law Amendments, Requests Comments on Whether Stark Law Is Barrier to Health Care Reform


By , , , , , and on Jul 22, 2015
Posted In Stark

The Centers for Medicare & Medicaid Services (CMS) recently published a notice of proposed rulemaking to amend its regulations implementing and interpreting the Stark Law. CMS also used this proposed rule to state its positions on certain questions of Stark Law interpretation and application, and to solicit comments from the industry on whether the Stark...

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Recent DOJ and OIG Actions Show Growing Federal Scrutiny of Physician Financial Arrangements


By , , , and on Jul 1, 2015
Posted In Compliance Developments

Over the last month the Office of Inspector General (OIG) of the Department of Health and Human Services and the Department of Justice (DOJ) have each taken actions that suggest an increasing appetite to examine the financial relationships between physicians and recipients of those physicians’ referrals under the federal Anti-Kickback Statute (AKS). By announcing new...

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