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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You Still Have Time to Sign Up For the NC Society of Health Care Attorneys Conference Oct. 6

It is not too late to join the North Carolina Society of Health Care Attorneys for its annual conference this Friday, Oct. 6, 2017, at the Rizzo Conference Center in Chapel Hill.

This year’s keynote address will be presented by Aaron McKethan, Ph.D., on the topic “Managing Change in Health Policy: State and Federal Perspectives.”

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Triple Canopy and Evolving Standards of Materiality Under the Civil False Claims Act (FCA)

By Joan H. Krause

In Universal Health Services v. United States ex rel. Escobar (UHS), the Supreme Court upheld the Civil False Claims Act (FCA) theory of “implied certification,” under which the submission of a claim for reimbursement “implies” that the claimant is in compliance with the statutes, regulations, and contract provisions necessary for that claim to be paid. Escobar was filed by the parents of a young woman who died after receiving Medicaid-covered mental health treatment from a Massachusetts clinic that violated state licensing and supervision regulations. Her parents alleged that the clinic’s claims were fraudulent because they implicitly (and falsely) represented that the facility was in compliance with the relevant provisions. A district court dismissed the suit, but the First Circuit reversed. In a unanimous opinion written by Justice Thomas, the Supreme Court held that where a defendant “makes specific representations about the goods or services provided, but knowingly fails to disclose . . . noncompliance with a statutory, regulatory, or contractual requirement[,] . . . liability may attach if the omission renders those representations misleading.”  But cautioning that such misrepresentations must be “material to the Government’s payment decision,” the Court reversed and remanded because the First Circuit had applied an impermissibly broad test.

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Health Law Section Charlotte Networking Breakfast Event

As a reminder, on Tuesday, Sept. 12 from 8 to 9 a.m, the NCBA Health Law Section will be hosting a networking breakfast.  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. As you probably know, the Health Law Section is an active chapter, and there are many ways that you can get involved, from CLE planning to pro bono. There are also opportunities for reduced membership dues for law students, so join us to learn more!

The breakfast will be at Robinson Bradshaw’s Charlotte office, located at 101 N. Tryon St., Suite 1900.  Validated parking is available in the 101 Independence Center Garage (120 N. Church St.).

This a great opportunity for Health Law Section members in the Charlotte area.  For any questions and to RSVP, please contact: crogers@robinsonbradshaw.com.  See everyone on Tuesday!


Bioethics Master Strengthens and Expands Health Care Practice

NCBA Health Law Section / N.C. Society of Health Law Attorneys

The Wake Forest Bioethics Graduate program admits attorneys seeking to advance their knowledge of health care ethics and public policy, as well as joint-degree law school students who realize the career flexibility that comes with graduate training in the moral dimensions of health care policy. Bioethics education can deepen a health care lawyer’s understanding of the broader social context of various aspects of the life-sciences industry. In depth study of both classic and emerging bioethical dilemmas can sharpen lawyer’s skills in representing health care clients. Or, a graduate degree can be a springboard for a lawyer looking to move into management or public policy career paths.

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Legislative Update For May 10, 2017

NCBA Health Law Section / N.C. Society of Health Law Attorneys

On behalf of the North Carolina Bar Association Health Law Section’s Legislative Committee,  we are providing the following 2017 post-crossover legislative update.

The North Carolina General Assembly has been considering a substantial number of bills of potential relevance to health law practitioners this session. The Health Law Section’s Legislative Committee, with the help of NCBA staff, has been monitoring these bills on virtually a daily basis.

The General Assembly’s rules provide for a “crossover date” during the legislative session, which this year was April 27. The importance of that date is essentially that, with certain caveats, unless a bill has passed one chamber (House or Senate) by the crossover date, the bill will no longer be considered by the legislature. The following listing provides brief descriptions of current proposed legislation, in two categories.

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