Articles and Blogs

CMS Letter to Clinicians – E/M Documentation Update

[11/09/18]

Posted on November 9, 2018 in Health Law News

Published by: Hall Render

On November 8, 2018, CMS released a letter to clinicians regarding E/M documentation and coding reform. This follows the CY 2019 Medicare Physician Fee Schedule Final Rule intentions to reduce burden on clinicians in furtherance of the agency’s “Patients Over Paperwork” initiative. Effective January 1, 2019, CMS will: Simplify the documentation of history and exam for…Read More

FDA Issues New Draft MOU for 503A Compounders Governing Cross-Border Dispensing and Comments Related to CGMP Compliance for Outsourcing Facilities

[11/02/18]

Posted on November 2, 2018 in Health Law News

Published by: Hall Render

On September 7, 2018, the United States Food and Drug Administration (“FDA”) issued a revised draft Memorandum of Understanding (“MOU”) that would govern interstate dispensing and distribution of “inordinate amounts” of compounded prescription drugs by certain compounding physicians and pharmacies. The concept of this MOU first appeared in the Compliance Policy Guidance issued by the…Read More

Health Provider News – November 2, 2018

[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 overhaul…Read More

Department of Homeland Security and FDA Collaborate to Address Medical Device Cybersecurity

[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 addresses…Read More

When a Deadline Isn’t a Deadline: Fifth Circuit Rules FCA Appeal Deadlines Turn on Government’s Intervention

[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] after…Read More

Whistleblower’s Dismissal with Prejudice Not the End of the Road for Qui Tam Action

[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. v….Read More

Civil Monetary Penalties Inflation Adjustment for 2018

[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 publication,…Read More

Newly Enacted Opioid Law: How Does It Impact Providers?

[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 House…Read More

Health Provider News – October 26, 2018

[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: Paying…Read More

Health Provider News – October 19, 2018

[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 opened…Read More