[11/02/18]
Posted on November 2, 2018 in Health Law News
Published by: Hall Render
NATIONAL HHS secretary warns Big Pharma: Lower prices, or ‘you’ll get whatever comes at you’ Amazon’s health-care ambitions shouldn’t be underestimated, says industry veteran HHS Unveils New Plan for Prescription Prices for Medicare Part B Drugs 15 leaders on why hospitals should hire a chief wellness officer Lawmakers ask CMS to reconsider ACO MSSP... READ MORE
[11/02/18]
Posted on November 2, 2018 in Health Law News
Published by: Hall Render
On October 15, 2018, the National Protection and Programs Directorate (“NPPD”) of the U.S. Department of Homeland Security (“DHS”) and the U.S. Food and Drug Administration (“FDA”) entered into a Memorandum of Agreement (“MOA”) that formalizes a long-standing relationship between the agencies and implements a new framework for increased collaboration, information-sharing and coordination that... READ MORE
Tags: CDRH, Center for Devices and Radiological Health, Cybersecurity, Cybersecurity threats and vulnerabilities, FDA, Medical Devices, National Protection and Programs Directorate, NPPD, Privacy
[10/31/18]
Posted on October 31, 2018 in False Claims Act Defense
Published by: Hall Render
Joining the other circuit courts, the Fifth Circuit extends the time to appeal a civil case if the United States was a party. As long as the United States was actively involved in the case prior to the appeal, any party has 60 days to appeal. Background In United States v. Ronald Conner, [1]... READ MORE
Tags: False Claims Act, FCA, Fifth Circuit, United States v. Ronald Conner
[10/30/18]
Posted on October 30, 2018 in False Claims Act Defense
Published by: Hall Render
The Fifth Circuit ruled that a whistleblower’s voluntary dismissal with prejudice cannot affect the Government’s ability to pursue related litigation. When the Government has not yet intervened, and thus is not a yet a party, a case cannot be dismissed with prejudice as to the Government by a whistleblower. Background In Vaughn, ex rel.... READ MORE
Tags: AKS, Anti-Kickback Statute, False Claims Act, FCA, Fifth Circuit, Northern District of Georgia, qui tam, Southern District of Texas, Vaughn ex rel. v. United Biologics, Voluntary Dismissal with Prejudice, whistleblower
[10/26/18]
Posted on October 26, 2018 in Health Law News
Published by: Hall Render
The U.S. Department of Health and Human Services (“HHS”) published in the Federal Register the 2018 updated civil monetary penalties (“CMPs”) adjusted for inflation as required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (§701 of Pub. Law 114-74) (the “Act”). The updated CMPs became effective on the date of... READ MORE
[10/26/18]
Posted on October 26, 2018 in Health Law News
Published by: Hall Render
On October 25, 2018, the president signed a wide-ranging bipartisan legislative package to address the opioid epidemic. The enactment of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act, (the “Act”) follows a lengthy process in both the Senate and... READ MORE
Tags: Centers for Disease Control and Prevention, IMD, Medicaid Institution for Mental Diseases, opioid crisis, Opioid Legislation, Opioids, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, SUPPORT for Patients and Communities Act
[10/26/18]
Posted on October 26, 2018 in Health Law News
Published by: Hall Render
NATIONAL After stalling for months, HHS plans to accelerate 340B changes Hospitals could save $11M per year by streamlining supply chain services Time Magazine: The Health Care 50: Fifty people transforming health care in 2018 OCR Drafts NPRM on ‘Good Faith’ Patient Data Disclosure Rules Consumerism driving hospitals to break down cybersecurity boundaries OIG:... READ MORE
[10/22/18]
Posted on October 22, 2018 in HR Insights for Health Care
Published by: Hall Render
NATIONAL Azar Issues 2nd HIPAA Privacy Rule Waiver in As Many Months Aetna Reaches Settlements with State AGs Over HIPAA Violations CMS signs up 1,547 providers for new bundled payment model Amazon, Walmart patents highlight potential of biometric monitoring Grassley calls for Federal Trade Commission to examine hospital, insurer contracting 39 new ASCs were... READ MORE
[10/19/18]
Posted on October 19, 2018 in Health Information Technology
Published by: Hall Render
On October 15, 2018, the Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced that it had reached a record $16 million settlement with Anthem arising out of alleged violations of the Privacy and Security Rules under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The settlement comes... READ MORE
Tags: cyber attack, Data Breach, ePHI, HIPAA, HIPAA Breach, OCR, Office for Civil Rights
[10/19/18]
Posted on October 19, 2018 in False Claims Act Defense
Published by: Hall Render
The Eleventh Circuit recently held that a qui tam relator cannot intervene in criminal forfeiture proceedings when the Government chooses to criminally prosecute fraud rather than intervene in a qui tam action. In United States v. Couch,[1] a former employee (“Relator”) of a pain management clinic in Alabama tried to recover amounts she believed... READ MORE
Tags: Criminal Forfeiture, Eleventh Circuit, False Claims Act, FCA, qui tam, relator, United States v. Couch