Health Law Advisor

On April 2, 2019, FDA issued a press release featuring a statement from FDA Commissioner Scott Gottlieb announcing the Agency’s latest enforcement actions taken against companies engaging in unlawful marketing of cannabidiol (CBD) products.  Coming just days before Gottlieb’s anticipated departure from the Agency, this news otherwise is unsurprising given recent events on the federal and state level.  In a December 2018 press release issued on the heels of the Farm Bill’s passage, FDA forecast its intention to step up enforcement against CBD products, and earlier this year ...

The importance of the Domain Name System (DNS) to your organization’s cybersecurity cannot be understated. Communications between computers on the Internet depend on DNS to get to their intended destination. Network communications begin with a query to DNS to resolve the human readable domain name to a numeric Internet Protocol (IP) address required by computers to route the transmission. A malicious party who is able to exploit a weakness in DNS can re-route sensitive traffic, including Protected Health Information (PHI), Personally Identifiable Information (PII) and ...

As employers are wrapping up their reporting under the Affordable Care Act (“ACA”) for the 2018 tax year (filings of Forms 1094-B/C and 1095-C/B with the IRS are due by April 1, 2019, if filing electronically), they should start preparing for new reporting obligations for the 2019 tax year.

After a string of failed efforts to repeal the ACA, Congress, through the Tax Cuts and Jobs Act of 2017 (“TCJA”), reduced the federal individual shared responsibility payment assessed (with limited exceptions) against individuals who failed to purchase health insurance to $0 beginning ...

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery ...

The information letter issued by the Department of Labor (the “DOL”) on February 27, 2019 (the “Information Letter”) provides a reminder to plan sponsors about the importance of disclosing the procedure for appointing authorized representatives in the benefit claim and appeal procedures for employee benefit plans subject to the Employee Retirement Income Security Act of 1976 (“ERISA”), as amended and also about the extent of the authority of the authorized representative. The Information Letter was in response to a query as to whether an entity that acts as a patient ...

On March 15, 2019, the Centers for Medicare & Medicaid Services (CMS) released proposed changes to its methodology for calculating Civil Money Penalties (CMPs) for Medicare Advantage (MA) and Part D Prescription Drug Plan (MA and Part D) sponsors.  The proposed changes would impact both the calculation methodology for 2019 as well as the CMP amounts for 2019 and beyond in an effort to increase plan accountability.  CMS is accepting comments on these proposed changes until April 15, 2019 at 11:59 PM ET.

Though CMS has exercised its statutory and regulatory authority to impose CMPs on MA ...

Despite recent welcome news to the home health agency (“HHA”) industry in Florida, Illinois, Michigan, and Texas following an end to Centers for Medicare & Medicaid Services’ ("CMS’s") long-standing HHA provider enrollment moratoria, CMS subsequently announced that it would place some newly enrolled HHAs in a provisional period of enhanced oversight. The purpose of the enhanced oversight period and the corresponding additional restrictions placed on certain HHAs is to help CMS address and closely monitor fraud, waste, and abuse concerns in the HHA industry, thus ...

On March 18, 2019, New Jersey Governor Phil Murphy signed a bill amending the New Jersey Law Against Discrimination (LAD) to prohibit contractual provisions that result in the wavier of a right or remedy provided under the LAD or prevent the disclosure of information pertaining to claims of discrimination, retaliation or harassment.   The amendment, which is immediately effective, prohibits any provision in an employment agreement, other than a collective bargaining agreement, that:

• Waives any substantive or procedural right or remedy relating to a claim of discrimination ...

The healthcare industry is still struggling to address its cybersecurity issues as 31 data breaches were reported in February 2019, exposing data from more than 2 million people.  However, the emergence of artificial intelligence (AI) may provide tools to reduce cyber risk.

AI cybersecurity tools can enable organizations to improve data security by detecting and thwarting potential threats through automated systems that continuously monitor network behavior and identify network abnormalities.  For example, AI may offer assistance in breach prevention by proactively ...

Our colleague David A. Clark at Epstein Becker Green was recently quoted in The New York Times, in “Did Your Doctor Disappear Without a Word? A Noncompete Clause Could Be the Reason,” by Michelle Andrews. Read more about the article here.