Dorsey Health Law Blog

Is Data the Next Frontier in ERISA Litigation?

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Health and retirement benefit plans subject to the Employee Retirement Income Security Act (“ERISA”) have troves of personal information regarding plan participants and their beneficiaries—e.g., participants’ age, marital status, personal assets, medical and prescription drug claim data, and medical history. Although the Health Insurance Portability & Accountability Act (“HIPAA”) regulates treatment of protected health information,...

Coronavirus Lawsuits Against Healthcare Providers are on the Rise

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Among its many impacts, the coronavirus pandemic has already spawned hundreds of employment and health-related lawsuits, with even more litigation likely as businesses continue to bring back workers and increase operations.  Many of these lawsuits have been aimed at employers in the healthcare sector and relate to workplace safety, retaliation, and wrongful termination or wrongful...

The Regulatory Sprint Catches up to HIPAA: New Proposed HIPAA Rules

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Today, the Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) which proposes significant changes to the Health Insurance Portability and Accountability Act (“HIPAA”) and to the Health Information Technology for Economic and Clinical Health Act (“HITECH”) Privacy Rule (the “Privacy Rule”).  The NPRM includes...

OIG Skeptical of Medical Device and Pharmaceutical Speaker Programs

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The Department of Health and Human Services Office of Inspector General (“OIG”) has issued a Special Fraud Alert to highlight what it views as inherent risks associated with speaker programs that pharmaceutical and medical device companies organize and fund. These programs are typically company-sponsored events at which one or more physicians or other health care...

Much-Anticipated Final Rules to Revise Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP Regulations Released under “Regulatory Sprint to Coordinated Care”

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On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their much-anticipated final rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and regulations under the...

2020’s a Bust, but HIPAA Enforcement Is on a Roll!

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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been actively enforcing HIPAA regulations this year, including a series of seven settlements under OCR’s Right of Access Initiative to enforce patients’ rights to timely access their medical records at a reasonable cost. This year, OCR has recorded...

Finalized Rule to Remove Disincentives to Living Organ Donation

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On September 22, 2020, the Department of Health and Human Services (“DHHS”) finalized a new rule to expand the scope of qualified reimbursable expenses incurred by living organ donors to include lost wages, child-care expenses, and elder-care expenses. The new rule goes into effect on October 22, 2020, and is a win for living organ...

CMS Issues Interim Final Rule to Enforce COVID-19 Reporting Requirements

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The Centers for Medicare and Medicaid Services (“CMS”) published an Interim Final Rule in the Federal Register on September 2, 2020 to supplement and strengthen the agency’s enforcement of COVID-19 reporting requirements.  The final rule also modifies various aspects of Medicare reimbursement methodologies for health plans, physicians, and other providers.  This post summarizes each of...

DOJ Demonstrates Continued Focus on Opioid Crisis with $600 Million Criminal and Civil Settlement Against Indivior Solutions, Indivior Inc., and Indivior plc

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The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. We would like to thank Vanessa J. Szalapski for the following post...

Is Your Compliance Program More than a Paper Program? DOJ Issues Revised Guidance for Evaluating Corporate Compliance Programs

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On June 1, 2020, the Department of Justice (“DOJ”) issued an updated version of its “Evaluation of Corporate Compliance Programs” (the “DOJ Guidance”), available here. The DOJ Guidance is an update to guidance first issued by the DOJ in February 2017 (which we described in our prior blog post), and was last updated by the...