Health Law Advisor

As discussed in an earlier blog post, the New York state Stop Hacks and Improve Electronic Data Security Act (or “SHIELD Act”), was signed into law on July 25, 2019.  A potential unintended side effect of the SHIELD Act may require health care companies to provide notification to the NY Attorney General for events that occurred well before its enforcement date. While the SHIELD Act’s data security requirements, which are covered under §4, will not come into effect until March 21, 2020, all other requirements, including the breach notification requirement, became effective on October 23, 2019.  The notification enforcement date is important for any Covered Entity, as defined by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), that has suffered a Breach, as defined by HIPAA, involving fewer than 500 individuals (“Minor HHS Breach”), was a breach of computerized data, and involved a New York resident.

Delaware is reminding its employers that a safe, drug-free workplace can pay.  On February 1, the state’s Department of Insurance (the “Department”) amended its regulations to emphasize the availability of workers’ compensation insurance discounts of up to 19 percent for employers who participate in the Delaware Workplace Safety Program (the “Program”), and who implement a drug-free workplace program at their worksites.  The amended regulations took effect on February 11, 2020.

The Workplace Safety Program

First implemented in 1989, the Program offers an ...

On January 28, 2020, the Department of Health & Human Services (“HHS”) Office for Civil Rights (“OCR”) addressed a federal court’s January 23rd invalidation of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) rule relating to the third-party requests for patient records. In Ciox Health, LLC v. Azar,[1] the court invalidated the 2013 Omnibus Rule’s mandate that all protected health information (“PHI”) maintained in any format (not just that in the electronic health record) by a covered entity be delivered to third parties at the request of an individual, as well as the 2016 limitation on fees that can be charged to third parties for copies of protected health information (“PHI”).

As enacted, HIPAA’s Privacy Rule limits what covered entities (or business associates acting on behalf of covered entities)[2] may charge an “individual” requesting a copy of their medical record to a “reasonable, cost-based fee”[3] (the “Patient Rate”). The Privacy Rule did not, however, place limitations on the fees that can be charged to other requestors of this information, such as other covered entities that need copies of the records for treatment purposes or for disclosures to attorneys or other third parties.  In order for some of these third parties to obtain the records, the patient would have to provide the covered entity with a valid HIPAA authorization.  

We have written extensively on mandatory vaccination policies and employers’ obligations to accommodate requests for exemption based on religious or disability grounds.  The Fifth Circuit Court of Appeals has issued a recent decision that provides helpful guidance to employers who mandate vaccinations.  In Horvath v. City of Leander, No. 18-51011 (5^th Cir. Jan. 9, 2020), the Fifth Circuit held that the defendant City of Leander did not violate a firefighter’s religious freedom when it discharged the firefighter after he refused to choose either of two accommodations to the ...

January 28th marks Data Privacy Day which commemorates the signing of the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data.  This international treaty is the first of its kind to address privacy and data protection.

Strong privacy and cybersecurity safeguards are paramount to the success of companies and the consumers they serve.  These issues are so critical they took center stage at the annual Consumer Technology Association’s Consumer Electronics Show (CES) held earlier this month where tech companies of all sizes promoted ...

Sponsors of health plans have long known that the only constant in life is change. In 2020, that is surely to remain true.

Ding-Dong! The Cadillac Tax Is Dead!

On December 20, 2019, as part of the year-end appropriations bill, the Affordable Care Act’s (ACA) so-called 40% “Cadillac Tax” on high-cost health plans was finally, after much lobbying and other efforts by sponsors and health care payers, put to an end with a full repeal. The “Cadillac Tax” was currently scheduled to take effect in 2022 (after two delays), and would have taxed employer-sponsored plans worth more than ...

Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act (“FCA”) for fiscal year (“FY”) 2019. An increase over the $2.9 billion recovered in FY 2018, FY 2019 reflected the ninth highest amount of recoveries in the past 30 years. The accompanying statistics released by DOJ reflect several themes related to FCA enforcement concerning the health care and life sciences industry.

The Health Care and Life Sciences Industry Accounted for Approximately 87 Percent of FY 2019 Recoveries

Consistent with previous years, fraud actions involving the health care and life sciences industries continue to drive DOJ’s FCA recoveries. Health care-related fraud recoveries alone have now exceeded $2 billion for 10 consecutive years. In FY 2019, health care-related matters generated approximately $2.6 billion in recoveries, or 85 percent of recoveries from all sectors combined, which does not include recoveries from state-based Medicaid actions with which DOJ may have assisted. The $71 million increase in recoveries from health care-related matters between FY 2018 and FY 2019 marks the third consecutive year of increasing health care-related recoveries. Notably, recoveries from health care-related cases brought directly by DOJ increased from $568 million to $695 million between FY 2018 and FY 2019, the second highest amount recovered in 30 years.

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and consolidation in 2020.  These predictions for 2020 are largely based on the increasing confluence of the following three key “drivers” of health industry transformation that is substantially underway:

1. The ongoing national imperative of reducing the cost of health care, via disease prevention and detection, and cost-effective, quality treatment, including more efficient care in ambulatory and retail settings;
2. Extraordinary advances in technologies which enhance disease prevention, detection and cost-effective treatment (e.g., artificial intelligence (AI)-driven diagnosis and treatment, virtual care, electronic medical record (EMR) systems, medical devices, gene therapy, and precision medicine); and
3. The aging baby-boomer population, with tens of millions of Americans entering into their 70s, 80s, and above.

A bill to amend the New Jersey Millville Dallas Airmotive Plant Loss Job Notification Act, also commonly referred to as the New Jersey WARN Act (“NJ WARN Act”), which the New Jersey Senate passed on December 16, 2019, if enacted, will create significant financial liability for covered New Jersey employers that undergo a mass layoff, or a transfer or termination of operations, by requiring the employer pay severance to both full-time and part-time employees.

The NJ Warn Act, enacted in 2007, requires New Jersey private employers with 100 or more full-time workers to provide 60-day ...

On December 19, 2019, New Jersey enacted legislation amending the New Jersey Law Against Discrimination (“NJLAD”) to add a definition for “Race” - which has always been a protected category under the NJLAD – and for the term “Protective hairstyle.”  The Amendment, referred to as the “CROWN Act” (short for “Create a Respectful and Open Workspace for Natural Hair Act”), amends the NJLAD to add the following to the statute’s list of definitions:

“Race” is inclusive of traits historically associated with race, including, but not limited to, hair texture ...