Elizabeth O’Connell

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FDA Publishes Guidance on Off-Label Use Communications

By Elizabeth O’Connell and Lee H. Rosebush on March 9, 2017 Posted in Uncategorized

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the FDA’s response to years of conflict between drug makers, which contend they have a first amendment right to communicate off label or information … Continue Reading

Hold the Phone! The Joint Commission Reinstates Ban on Texting Orders

By Elizabeth O’Connell and Vimala Devassy on February 7, 2017 Posted in Uncategorized

The Joint Commission (TJC) and the Centers for Medicare & Medicaid Services (CMS) took a firm stance against physicians texting patient orders in a recent joint statement, clarifying that it is not acceptable for physicians or licensed independent practitioners to text orders for patient care, treatment or services to hospitals or other healthcare providers. Instead, computerized … Continue Reading

IRC Section 501(r): An ACA Provision That’s Likely Here to Stay

By Laurice Rutledge Lambert and Elizabeth O’Connell on December 23, 2016 Posted in Uncategorized

For tax-exempt hospitals, the Section 501(r) Internal Revenue Code (IRC) requirements of the Affordable Care Act are “old news” by now. However, despite the recent focus on repeal of the ACA, it is worth noting that this provision is likely here to stay. Sen. Charles Grassley (R-IA), a long-time advocate for low-income, uninsured, and underinsured … Continue Reading

Nursing Home Arbitration Ban: There’s a Line in the Sand – But the Tide May Still Come In

By Emily Crosby and Elizabeth O’Connell on November 29, 2016 Posted in Uncategorized

On November 7, 2016 a federal judge in Mississippi granted a request to temporarily enjoin CMS from implementing a federal rule, scheduled to take effect November 28, 2016, banning the use of mandatory pre-dispute arbitration agreements by federally-funded skilled nursing facilities (Rule). Despite noting the potential public policy arguments for the Rule, the court found that … Continue Reading

ONC Contracting Guide Aims to Restore Balanced Bargaining Between Providers and EHR Vendors

By Vimala Devassy and Elizabeth O’Connell on October 27, 2016 Posted in Uncategorized

The HHS Office of the National Coordinator for Health Information Technology (ONC) recently published a contracting Guide to assist healthcare providers when entering into electronic health record (EHR) contracts with EHR vendors. Issued in response to provider complaints that EHR contracts often contain hidden fees and restrictions that prevent sharing of patient health records with other providers, … Continue Reading