Health Law Policy Matters

Written by:  Heidi Lawson and Scott Rader William Gallagher Associates, a Boston-based insurance broker, has announced the rollout of a new policy to cover Ebola-related losses at hospitals and other healthcare providers involved in primary care emergency treatment.  Styled as Pandemic Disease Business Interruption Insurance and provided by the Ark Syndicate at Lloyd’s, this policy will provide insurance coverage to healthcare providers … Read more

Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 patient admissions by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the False Claims Act (FCA). Life Care Centers is accused of billing … Read more

Written by: Nili S. Yolin Last month, a woman sued a health plan, claiming that she was intentionally misled about which physicians were participating providers in the company’s online health insurance exchange established under the Affordable Care Act.  The petitioner alleged that the plan displayed the names of the physicians on its website, and that she … Read more

Yesterday morning, the U.S. Supreme Court announced its decision in the much anticipated Burwell v. Hobby Lobby case, holding that closely-held corporations are protected by the Religious Freedom Restoration Act of 1993 (“RFRA”), and therefore cannot be required to pay for employee health plans that cover contraceptives if the corporation’s owners have religious objections. The Affordable Care Act requires … Read more

The most recent Office for Civil Rights (“OCR”) HIPAA enforcement action serves as an important reminder to health care providers of the security risks associated with a mishandled medical records custody transfer and the risks of leaving paper records in the driveway.  The enforcement action and ensuing settlement – an $800,000 fine and corrective action plan – … Read more

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B Program operations.  But then, as I posted late last month, a federal district court invalidated HRSA’s earlier rulemaking involving the 340B … Read more

The year 2014 looks to be a year of major developments for the 340B Drug Discount Program.  We have seen (1) a first in terms of the Health Resources and Services Administration (HRSA) imposing sanctions on audited entities, (2) written arguments in a lawsuit over the rules governing 340B access to orphan drugs, and (3) … Read more

Since 2009, the HHS Office for Civil Rights (“OCR”) has posted all large data breaches – those that involve 500 or more individuals – online on its so-called “Wall of Shame.”  In 2013, 160 large data breaches were reported to OCR and posted on the Wall of Shame.  Taken together, these breaches involved the unsecured protected health information … Read more

The Office for Civil Rights (OCR) is closing out 2013 with a reminder of the importance of an effective HIPAA compliance program.  On December 26, 2013, OCR announced a resolution agreement with a Massachusetts physician practice to settle violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy, security and breach notification rules. The … Read more

Written By: Kimberly Gold With the September 23, 2013 compliance date for the HIPAA Omnibus Rule only one week away, the Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) have developed model Notices of Privacy Practices (“NPP”) to help health care providers and health plans ensure compliance with the HIPAA … Read more