Save the Date For Our Annual Meeting: March 8, 2019

The NCBA Health Law Section’s Annual Meeting and CLE Program has a new date and time for 2019. Please plan to join us at the Bar Center in Cary on March 8, 2019.  We received great feedback about the extra networking opportunities at our 2018 program, so we are adding a networking breakfast to the 2019 program to give us all more time to catch up with our colleagues from across the state. If you have suggestions for program topics or speakers (or want to volunteer as a speaker), please contact Sarah Crotts at scrotts@wallbabcock.com.

White House ‘Blueprint to Lower Drug Prices’: Large Aspirations, Little Detail

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By Stephanie Trunk and Erin Atkins

This article first appeared on the Arent Fox LLP Health Care Counsel blog. 

Following delays and much build up, the White House and the Department of Health and Human Services (HHS) have released their plan to address rising pharmaceutical prices and out-of-pocket costs directly impacting patients.  The plan is known as the “American Patients First” program, as outlined in “The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs” (the Blueprint).   As part of this, HHS has published a formal request for information (RFI) seeking public comment on the questions and issues raised in Section V of the Blueprint (summarized below).  Comments are due to HHS on or before July 16, 2018.  We encourage all interested stakeholders to utilize this opportunity to submit feedback to the agency.

One initial impression of the Blueprint is that many of the proposed solutions are not defined in great detail and will take time and agency (and in some cases Congressional) action in order to implement.  In addition, many of the solutions were previously articulated in President Trump’s 2019 budget, and do not reflect novel policy.  Additionally, many of the issues raised in the Blueprint are familiar to those actively engaged in or following the drug industry, but will require active engagement between HHS and the industry to refine and address.

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Overtime, Non-Competes & Employee Medical Records: Three Topics for Employers in the Healthcare Field

By  L. Diane Tindall, Daniel Palmieri and Jenna Borders

PAY AND OVERTIME ISSUES FOR HEALTHCARE WORKERS

The Fair Labor Standards Act (FLSA) is the federal law that mandates the payment of a federal minimum wage and overtime pay to workers who do not fall within a specific FLSA exemption.  The most common of these exemptions under the FLSA are the so-called “white collar” exemptions for employees whose pay and duties reflect their exercise of real managerial or executive authority in the workplace and their ability to better influence their compensation.  In general, in order to be exempt from the minimum wage and overtime provisions under the white collar exemptions of the FLSA, an employee: (1) must be paid at least $455 per week (or $24,300 per year); must be paid on a “salary basis” (with some exceptions); and (3) must perform duties that are consistent with an executive, administrative or professional position (the “duties test”).  To be paid on a salary basis, an employee must receive the same pay each work week in which he or she performs any work (with a very few limited exceptions) without any deduction for the quantity or quality of work performed.

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2018 Health Law Section Annual Meeting and Joint CLE with the Litigation Section

Have you kept up with the General Assembly and proposed legislation that affects the health care industry? If not, no need to worry, we’ve done it for you!

Please join us this Friday, April 27, 2018, to hear Cody Hand provide his annual legislative update at the Health Law and Litigation Sections’ joint CLE program at the Greensboro Marriott Downtown, with presentations by N.C. Department of Health and Human Services Secretary Mandy Cohen, Attorney General Josh Stein and many other great speakers!

You’ll receive 6 total CLE credits, including 1.0 hour ethics/professional responsibility, and 1.0 hour substance abuse/mental health.  Click here to learn more and to register.

2018 Health Law Section Annual Meeting and Joint CLE With the Litigation Section

Have you heard of the opioid epidemic, but don’t know much about it? Or, perhaps you’ve heard of it and have been wondering what North Carolina is doing to address it – either way, we’ve got you covered at the Health Law Section Annual Meeting & Joint CLE with the Litigation Section! Come hear N.C. Attorney General Josh Stein speak about the opioid epidemic in North Carolina and beyond, including the scope of the problem, prevention strategies for physicians and other health care providers, the STOP Act and the Synthetic Opioid Control Act, supporting treatment and recovery services, and support for law enforcement.

Did we also mention that Pamela Morrison with Coastal Horizons Center in Wilmington will be on hand to make this a substance abuse CLE credit presentation, with a discussion about the treatment of substance use disorders and how legal professionals can help and get help.  Please plan to join the Health Law and Litigation Sections for a joint CLE program Friday April 27, 2018 at the Greensboro Marriott Downtown, with presentations by Attorney General Stein, DHHS Secretary Mandy Cohen, and many other great speakers!  You’ll receive 6 total CLE credits, including 1.0 hour ethics/professional responsibility, and 1.0 hour substance abuse/mental health.  Visit http://gateway.ncbar.org/store/seminar/seminar.php?seminar=109189 to learn more and to register.

2018 Health Law Section Annual Meeting and Joint CLE With the Litigation Section

Want to learn more about the state of health care in North Carolina directly from guest speaker Mandy Cohen, Secretary of NC Department of Health & Human Services? Sec. Cohen will speak about North Carolina’s transition to Medicaid managed care, combating the opioid crisis and improving early childhood health and education. Please plan to join the Health Law and Litigation Sections for a joint CLE program Friday, April 27, 2018 at the Greensboro Marriott Downtown, with presentations by Sec. Cohen, Attorney General Josh Stein, and many other great speakers!

You’ll receive 6.0 hours total CLE credits, including 1.0 hour ethics/professional responsibility, and 1.0 hour substance abuse/mental health.

Learn more and register here.

Final FDA Guidance: Keeping the Surgical Suite from Becoming a Manufacturing Facility

By Justin M. Mann

An early focus of the U.S. Food and Drug Administration (FDA) under the new leadership of FDA Commissioner Scott Gottlieb, MD, has been regenerative medicines, which “hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies.”  One of the areas of regenerative medicine that can be particularly difficult to regulate is treatments with human cells, tissues, and cellular and tissue-based products (HCT/Ps), because these treatments tend to be fairly individualized and there is a fine line of demarcation between medical practice and processes regulated by FDA.

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The UNC Cancer Pro Bono Legal Project Needs You!

If you have already volunteered as a supervising attorney with the UNC School of Law’s Cancer Project, you know how meaningful advance directive documents can be in bringing peace of mind to individuals facing daunting and difficult medical situations. If you have not had the chance to volunteer in this role, you are invited to participate now!

To learn more about this program, and about the substantive law which it provides, please register to attend the UNC Cancer Pro Bono Legal Project CLE, to be held at the UNC School of Law on January 26 at 9 a.m. This CLE will provide an overview of substantive law helpful to attorneys participating in the UNC Cancer Pro Bono Legal Project, a collaborative project sponsored by the UNC School of Law’s Pro Bono Program, N.C. Cancer Hospital, and Legal Aid of North Carolina. The CLE also will include a review of changes to the law surrounding advance directives documents, new for 2018.

While this CLE is provided free of charge — in hopes that you will volunteer (or continue to volunteer!) as a supervising attorney through the program — you will be responsible for paying your own CLE fee to the state bar ($3.50/hour).

Click here to register for the CLE program.

 

 

Fallout From the Sunshine Act 

By Richard S. Saver and MacKenzie Dickerman

All eyes are once again on health care reform. Amidst the present uncertainty, one law seems likely here to stay—the Physician Payments Sunshine Act (“Sunshine Act”). Part of the Patient Protection and Affordable Care Act, the Sunshine Act is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. As the law has moved beyond the implementation phase, with about three and one-half years of data accrued, it is an opportune time to evaluate its progress. In this post, we highlight what the Sunshine Act has revealed and its downstream effects.

Of particular interest to the health law bar, counsel in civil litigation are recognizing that the Sunshine Act serves as an important information resource.

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Asheville Area Members: Join Us For a Mixer At the Grove Park Oct. 18

As a reminder, on Wednesday, Oct. 18 starting at 6 p.m., the NCBA Health Law Section will host a “Mix, Mingle and Network” event at the Presidents Lounge, Omni Grove Park Inn, Asheville.  We are excited for an opportunity for our members and friends of the section to have a way to mingle in person and learn more about our section. The Health Law Section is an active chapter, and there are many ways that you can get involved, from CLE planning to pro bono.

Free parking for this event is available in the Sammons Wing Parking Deck. This a great opportunity for Health Law Section members in the Asheville area. For any questions and to RSVP, please contact: jheath@williamsmullen.com.  See everyone Wednesday, Oct. 18!

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