NLJ Names Kelly Cleary a Health Care Trailblazer

(Washington, D.C.) – The National Law Journal has selected Akin Gump health care and life sciences partner Kelly Cleary as a 2021 Health Care | Life Science Trailblazer, recognizing those who “have moved the needle in the legal industry.”

In her published profile, Ms. Cleary speaks of serendipity as responsible for her career in health care law, crediting struggles with organic chemistry in college with moving her away from the pre-med track.

Among the trails she has blazed, the profile notes that she served as Deputy GC for the Department of Health and Human Services (HHS), where she was also the lead legal counselor and advisor to the Centers for Medicare & Medicaid Services (CMS) as well as to HHS leadership on federal health care programs.

One of the cases on which she served as lead attorney was Allina v. Azar Health, a case that went before the U.S. Supreme Court and led to changes in CMS’s rulemaking and guidance practices. Of this case, she said, “It was a challenge to how the agency goes about issuing subregulatory guidance. It was a loss, but we used it to make the process more transparent and more along the lines of what Congress had originally intended.”

The profile notes that she served as lead attorney on other initiatives, including involving modernization of anti-kickback and physician self-referral regulations, promotion of interoperability and patient access to health information, and drug pricing.

Contrasting her work at Akin Gump with that at HHS, Ms. Cleary said, “The laws are very complex, and in my role now as outside counsel, we help companies follow the rules. But when I was inside, we were setting up policies and procedures so companies could come in and get some certainty that they were complying with the law.”

Looking forward, she noted that she believes changes in laws and policies will follow the introduction of increasing numbers of digital health care products to the market, saying “Innovative new products are breaking the mold because federal laws regarding how to cover and pay for them were written without these smarter digital technologies in mind. I’m looking forward to helping clients navigate this uncharted territory.”

Akin Gump Strauss Hauer & Feld LLP is a leading international law firm with more than 900 lawyers in offices throughout the United States, Europe, Asia and the Middle East.

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