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Congress Explores Surprise Medical Bill Legislation to Reduce Impact on Patients

By Helaine I. Fingold & Sidra S. Zaidi on August 21, 2019

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Federal lawmakers are debating legislation to address surprise medical bills that, if passed in its current form, would significantly impact how hospitals, physicians and insurers negotiate payment for the provision of certain out-of-network services. A bipartisan coalition led by Senator Lamar Alexander (R-Tennessee), Chairman of the Senate Health, Education, Labor and Pension Committee, and Senator Patty Murray (D-Washington) aims to present to the President for signature a bill to curb surprise billing practices by the…

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August 21 Effective Date for New EPA Standards for Management of Hazardous Waste Pharmaceuticals

By John S. Linehan & Christopher Smith on August 16, 2019

We recently outlined key provisions of the Environmental Protection Agency’s (EPA’s) Final Rule modifying the standards governing industry management of hazardous waste pharmaceuticals, which become effective August 21, 2019. Client Alert Impacted industries must immediately comply with the nationwide ban on the sewering of hazardous waste pharmaceuticals as of the August 21st effective date. The ban applies to a wide range of stakeholders, including, but not limited to reverse distributors, pharmacies, hospitals, and wholesalers. Additional…

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What’s New in E-Cigarette Regulation?

By Bonnie Scott on August 14, 2019

There is little question that youth e-cigarette use has been on the rise. In 2018, an estimated 3.6 million kids reported “current use” of e-cigarettes (defined as use on at least one day in the past 30 days), up from just 220,000 kids reporting such use in 2011 (See National Youth Tobacco Survey findings). Although youth e-cigarette use raises public health concerns, there’s also a public health upside to e-cigarettes, as they have been…

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Up in Smoke: The Countdown on Vape Enforcement Discretion Begins

By Matthew Sprankle & Audrey Davis on August 13, 2019

On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco products on the market as of the August 8, 2016 deeming rule that extended FDA’s regulatory jurisdiction to include all…

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Feds Exhibit Continued Interest in Prosecuting Illegal Relationships Between Laboratories and Marketers

By Clay Lee on July 17, 2019

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On July 8, 2019, Anthony Camillo, owner of Allegiance Medical Laboratory and AMS Medical Laboratory, was sentenced to 30 months in prison by a federal judge in the Eastern District of Missouri. He was ordered to pay $3.4 million in restitution for violations of the anti-kickback statute, associated conspiracy charges, and illegal kickbacks related to various health care fraud schemes to defraud federal health care benefit programs. Those operating in the clinical laboratory testing space…

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Privacy Concerns Loom as Direct-to-Consumer Genetic Testing Industry Grows

By Brian Hedgeman & Alaap Shah on June 28, 2019

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The market for direct-to-consumer (“DTC”) genetic testing has increased dramatically over recent years as more people are using at-home DNA tests. The global market for this industry is projected to hit $2.5 billion by 2024. Many consumers subscribe to DTC genetic testing because they can provide insights into genetic backgrounds and ancestry. However, as more consumers’ genetic data becomes available and is shared, legal experts are growing concerned that safeguards implemented by U.S. companies…

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Whether Worth Less or Worthless, Quality of Care Issues Under the FCA Are Worth Noting

By Audrey Davis & Clay Lee on June 6, 2019

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On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following: (1) administer medications as prescribed, (2) provide standard infection control resulting in urinary tract and wound infections, (3) attend to…

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FDA Hosts Long-Awaited Cannabis Public Hearing

By Megan Robertson, Lauren A. Farruggia & Brian Hedgeman on June 4, 2019

On May 31, 2019, the U.S. Food and Drug Administration (“FDA”) hosted its much-anticipated public hearing titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” (discussed in our prior blog post). The day-long hearing presented an opportunity for FDA panel members to engage directly with stakeholders on the regulatory future of cannabis or cannabis-derived products within the scope of FDA’s jurisdiction. Acting FDA Commissioner Ned Sharpless, M.D., kicked off discussions, reminding…

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The Role of Patient Preference in Medical Device Evaluation

By Bonnie Scott on May 23, 2019

When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in? On May 3, 2019, FDA established a docket to collect public input on a proposed list of patient preference-sensitive areas for medical device review, and posed certain related questions (comments are due July 2,…

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FDA Declines to Ban Breast Implants, Will Require Full MDR Reporting by Manufacturers

By Brian Hedgeman on May 16, 2019

Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants. The March 26, 2019,…

Health Law Advisor

Thought Leaders on Laws and Regulations Affecting Health Care and Life Sciences

Blog Authors

Congress Explores Surprise Medical Bill Legislation to Reduce Impact on Patients

August 21 Effective Date for New EPA Standards for Management of Hazardous Waste Pharmaceuticals

What’s New in E-Cigarette Regulation?

Up in Smoke: The Countdown on Vape Enforcement Discretion Begins

Feds Exhibit Continued Interest in Prosecuting Illegal Relationships Between Laboratories and Marketers

Privacy Concerns Loom as Direct-to-Consumer Genetic Testing Industry Grows

Whether Worth Less or Worthless, Quality of Care Issues Under the FCA Are Worth Noting

FDA Hosts Long-Awaited Cannabis Public Hearing

The Role of Patient Preference in Medical Device Evaluation

FDA Declines to Ban Breast Implants, Will Require Full MDR Reporting by Manufacturers

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