Lanton Law Blog

Learn about the latest trends and activities through our blog posts.

Georgia Supreme Court Sets Data Breach Precedent

In 2016, the Athens Orthopedic Clinic in Georgia was hacked by an anonymous hacking group called the “Dark Overlord.” The group’s action caused a major data breach and affected approximately 200,000 patients. The information obtained involved social security numbers, health insurance information, birth dates, and addresses.

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Pharmacy Times Recaps Lanton Law's NASP Presentation on the FDA Biosimilars Action Plan

During the 2019 National Association of Specialty Pharmacy Annual Meeting and Expo, Ron Lanton III, Esq, reviewed the FDA Biosimilars Action Plan, its implications for the biosimilar marketplace, recent legislation set to influence the biosimilar pathway and drug accessibility, and the future of the biosimilar market.

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Federal Privacy Laws Are Currently in the Making

In preparation for 2020, Lanton Law is forecasting that it is more likely than not that some form of federal privacy legislation will become law in 2020. One proposed legislative candidate for privacy in 2020 is the Consumer Online Privacy Rights Act (COPRA).

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Texas v. United States (An ACA Ruling)

On December 18, 2019 the industry witnessed the U.S. Court of Appeals for the 5th Circuit issue its ruling, which found that while the individual mandate is unconstitutional, the federal district court must decide on whether the remaining portion of the ACA could remain intact.

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What Will Happen to Biosimilars in the USMCA Agreement in 2020?

Back in August I started an analysis of how biosimilars will be impacted in the new United States-Mexico-Canada Agreement (USMCA). To refresh, in a follow up on a 2016 campaign promise to renegotiate the North American Free Trade Agreement (NAFTA), the Administration has been engaging Mexico and Canada in an effort to create and ratify the USMCA. 

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New Draft Importation Rule Released

A new pilot program that allows states to import from Canada and allow manufacturers to voluntarily import has been announced via a draft rule through HHS and the FDA. The program would give states and nonfederal government entities the ability to import from Canada by applying to the FDA. Higher priced drugs such as biologics are not included in the draft rule.

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CMS Star Ratings: Will Biosimilars Benefit?

The Centers for Medicare and Medicaid Services (CMS) star ratings system was created in 2007 for insurance plans operating under both the Medicare Advantage and Part D. This 1 to 5 system (with 5 being the highest rating) is a way for CMS to measure the value of a plan and determine whether to continue to allow it to be part of the program. However, it’s more than just the plan, since the plan’s providers play a key role in how CMS evaluates each plan.

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More Data Oversight on the Horizon

No matter what, technology will always move faster than the law. With this maxim and our ever increasing reliance on convenient information, we have seen technology companies try to bring us what we want to see while also collecting a staggering amount of information on consumers. With regulations scant on personal data, Congress is slowly becoming more active in making policy governing technology. 

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New PBM Legislation Advances in Congress

Congresswoman Amy Spanberger (D-VA) has sponsored H.R. 2115 titled “Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act.” This is important for healthcare stakeholders, as this proposed legislation requires greater transparency for discounts provided by manufacturers. This bill also proposes to include real-time benefit information as part of a prescription drug plan’s electronic prescription program under Medicare. 

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