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Remuneration? Not If It’s Fair Market Value, Says Eleventh Circuit

Bingham v. HCA, Inc., a recent Eleventh Circuit case, highlights the centrality of fair market value to Anti-Kickback Statute (AKS) analyses. This decision is significant for several reasons and we expect to see Bingham cited...more

CMS Publishes Proposed Amendments to Stark Law Advisory Opinion Regulations

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule, which included substantial changes to the physician self-referral law (Stark Law)...more

Third Time Might Be the Charm: District Court Orders HHS to Clear the Medicare Appeals Backlog by 2022

The US District Court for the District of Columbia issued a mandamus order on November 1 requiring HHS to clear the Medicare administrative appeals backlog by the conclusion of 2022. A dedicated $182.3 million appropriation,...more

Health Care Enforcement Quarterly Roundup - Q3 | September 2018

In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry that we have observed over the past few months. In this issue, we report on the practical...more

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

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...more

Digital Health Opportunities Under Federal Fraud and Abuse Regulatory Reform

The US Department of Health and Humans Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) have launched the Regulatory Sprint to Coordinated Care, a reform effort that will address several key health care...more

CMS Announces New Settlement Initiative Addressing Medicare Appeals Backlog, Enhancing Provider Appeal Options

In a Medicare Learning Network call on January 9, the Centers for Medicare and Medicaid Services provided specifics related to its new “Low Volume Appeals Settlement” initiative, allowing qualifying providers to settle...more

Medicare Appeals Backlog: A Setback and New Opportunities for Providers

As of June 2017, the Office of Medicare, Hearing and Appeals (OMHA) had 607,402 appeals pending with a current estimated wait time of three years for an Administrative Law Judge to process a provider’s appeal. At this rate,...more

CMS Finalizes Stark Law Amendments

On November 16, 2015, the Centers for Medicare and Medicaid Services (CMS) published the 2016 Medicare Physician Fee Schedule final rule with comment period in the Federal Register at 80 Fed. Reg. 70,886, which includes a...more

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

On July 8, 2015, the Centers for Medicare & Medicaid Services (CMS) published a notice of proposed rulemaking to amend its regulations implementing and interpreting the Stark Law (the Proposed Rule). 80 Fed. Reg. 41,686,...more

OIG Proposes Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more

OCR Issues Final Modifications to the HIPAA Privacy, Security, Breach Notification and Enforcement Rules to Implement the HITECH...

On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security...more

HIPAA De-Identification Guidance

Office of Civil Rights has released additional guidance addressing the de-identification of protected health information in accordance with the HIPAA Privacy Rule. Covered entities should review their current...more

Essential Health Benefits Proposed Rule: Additional Detail with Few Surprises

The essential health benefits proposed rule, issued on November 20, 2012, defines the so-called Essential Health Benefits Package, composed of essential health benefits, cost-sharing limitations and actuarial value...more

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