Policy & Compliance

Expert Analysis

• What To Expect After FDA Warnings To GLP-1 Compounders

  

  The U.S. Food and Drug Administration's recent warning letters to companies advertising compounded versions of GLP-1 medications raise questions not just about the enforcement outlook for marketing such products, but also about the future of drug compounding as a whole, say attorneys at Spencer Fane.

• How Financial Cos. Can Prep As NYDFS Cyber Changes Loom

  

  Financial institutions supervised by the New York State Department of Financial Services can prepare for two critical cybersecurity requirements relating to multifactor authentication and asset inventories, effective Nov. 1, by conducting gap analyses and allocating resources to high-risk assets, among other steps, say attorneys at Pillsbury.

• How Courts May Interpret Data-Driven Healthcare Fraud Suits

  

  As the U.S. Department of Justice and other agencies increasingly turn to data mining as an enforcement tool, courts will have to determine how far data alone can take a fraud case, and sound theory, clinical expertise and institutional context will play an important role, say Jaime Jones at Sidley and Andrée-Anne Fournier and Atang Gilika at Analysis Group.

• How Gov't Shutdown Will Affect Federal Health Agencies

  

  Federal health agencies' contingency plans indicate that many major programs will remain insulated from disruption during the ongoing government shutdown, but significant policy proposals will likely be delayed and the Trump administration's emphasis on reduction-in-force plans distinguishes this shutdown from past lapses, says Miranda Franco at Holland & Knight.

• Assessing Legal, Regulatory Hurdles Of Healthcare Offshoring

  

  The offshoring of administrative, nonclinical functions has emerged as an increasingly attractive option for healthcare companies seeking to reduce costs, but this presents challenges in navigating the web of state restrictions on the access or storage of patient data outside the U.S., say attorneys at McDermott.

• 5 Years In, COVID-19 Fraud Enforcement Landscape Is Shifting

  

  As the government moves pandemic fraud enforcement from small-dollar individual prosecutions to high-value corporate cases, and billions of dollars remain unaccounted for, companies and defense attorneys must take steps now to prepare for the next five years of scrutiny, says attorney David Tarras.

• Courts Keep Upping Standing Ante In ERISA Healthcare Suits

  

  As Article III standing becomes increasingly important in litigation brought by employer-sponsored health plan members under the Employee Retirement Income Security Act, several recent cases suggest that courts are taking a more scrutinizing approach to the standing inquiry in both class actions and individual matters, say attorneys at Crowell & Moring.

• Calif. Bill May Shake Up Healthcare Investment Landscape

  

  If signed by the governor, newly passed California legislation would significantly expand the Office of Health Care Affordability's oversight of private equity and hedge fund investments in healthcare companies and management services organizations, and raise several questions about companies' data confidentiality and filing burdens, say attorneys at Ropes & Gray.

• Pharma Copay Programs Raise Complex Economic Questions

  

  The growing prevalence of copay accumulator and maximizer programs in the pharmaceutical industry is drawing increased scrutiny from patients, advocacy groups, lawmakers and courts, bringing complex questions about how financial responsibility for prescription drug purchases is determined and complicating damages assessments in litigation, say analysts at Analysis Group.

• When AI Denies, Insurance Bad Faith Claims May Follow

  

  Two recent rulings from Minnesota and Kentucky federal courts signal that past statements about claims-handling practices may leave insurers using artificial intelligence programs in claims administration vulnerable to suits alleging bad faith and unfair trade practices, say attorneys at Cozen O'Connor.

• Health Insurance Kickback Cases Signal Greater Gov't Focus

  

  A series of recent indictments by federal prosecutors in California suggests that the Eliminating Kickbacks in Recovery Act is gaining momentum as an enforcement tool against illegal inducement of patient referrals in the realm of commercial health insurance, say attorneys at BakerHostetler.

• FDA Transparency Plans Raise Investor Disclosure Red Flags

  

  The U.S. Food and Drug Administration’s recently announced intent to publish complete response letters for unapproved drugs and devices implicates certain investor disclosure requirements under securities laws, making it necessary for life sciences and biotech companies to adopt robust controls going forward, say attorneys at Arnold & Porter.

• With Obligor Ruling, Ohio Justices Calm Lending Waters

  

  A recent decision by the Ohio Supreme Court, affirming a fundamental principle that lenders have no duty to disclose material risks to obligors, provides clarity for commercial lending practices in Ohio and beyond, and offers a reminder of the risks presented by guarantee arrangements, says Carrie Brosius at Vorys.