Health Law Advisor

GenomeDx Biosciences Corp., which markets a genomic test (Decipher®) intended to assess the aggressiveness of prostate cancer, has agreed to pay $1.99 million to the U.S. Department of Justice to resolve allegations that it violated the False Claims Act (31 U.S.C. §§ 3729 et seq.)(“FCA”) by submitting claims to Medicare for tests conducted to evaluate treatment options for men after prostate surgery.

The government and a whistleblower alleged that between September 2015 and June 2017, GenomeDx knowingly submitted Medicare reimbursement claims for the Decipher® test ...

Gummies, brownies, sodas, cookies . . . consumer appetite for food and dietary supplement products containing cannabidiol (“CBD”) has grown over the last few years as states have moved to legalize cannabis for medical or limited recreational use.  With the passage of the 2018 Farm Bill on December 20, 2018, which legalized the cultivation of hemp for certain purposes, the “edibles” industry appeared poised for further expansion.

However, recent developments at both the federal and state level may be putting the “edibles” industry on a diet.  In the past week, bans on the ...

The telehealth industry has experienced constant developments in the regulatory landscape at both the federal and state level over the past several years, and we are confident these changes will continue into 2019 as the utilization of telehealth services continues to evolve and mature. A notable area of activity is how regulators, are approaching the telehealth industry, in particular remote prescribing applications of this platform.

On the federal level, we should expect to see promulgation of regulations by the U.S. Drug Enforcement Administration outlining the special ...

There is a new kid on the block . . . the Chief Data Officer (CDO).  There is no surprise in our data-driven world that such a role would exist. Yet, many organizations struggle with defining the role and value of the CDO. Effective implementation of a CDO may be informed by other historical evolutions in the C-Suite.

Examining the rise of the Chief Compliance Officer (CCO) in the 2000’s mirrors some of the same frustrations that organizations faced when implementing the CCO role. While organizations were accustomed to having legal, HR, and internal audit departments working together to ...

For the first time since 2008, the Advanced Medical Technology Association (“AdvaMed”) has updated its “Code of Ethics on Interactions with Health Care Professionals.”  These updates were announced on January 9, 2019 and will become effective on January 1, 2020.

AdvaMed’s goal in updating the Code was to address the evolving nature of interactions between the medical device industry and health care professionals (“HCPs”), bring existing examples up-to-date, and enhance user-friendliness.  Topics that were previously covered in multiple areas of the Code are now ...

Health care providers and custodial agencies operating in Illinois are now subject to new obligations under the Health Care Violence Prevention Act (210 ILCS 160/1 et seq.)(“HCVPA”), which went into effect on January 1, 2019. The HCVPA, which was enacted in response to two 2017 incidents involving inmates who assaulted hospital nurses, seeks to reduce the growing rates of violence against health care workers.

The HCVPA establishes both preventive and curative measures to protect health care workers. Health care providers are required to create an OSHA-compliant workplace ...

The U.S. Department of Justice reached a January 31, 2019 settlement of an American with Disabilities Act ("ADA") Title III complaint against health care provider Selma Medical Associates relating to provision of medical services to an individual with opioid use disorder ("OUD").  The settlement is notable for health care providers and employers as it makes clear that DOJ considers OUD as a disability under the ADA thereby triggering the full panoply of ADA rights for those with OUD.

The DOJ complaint was premised on the alleged refusal of Selma Medical to schedule a new patient family ...

Data is king!  A robust privacy, security and data governance approach to data management can position an organization to avoid pitfalls and maximize value from its data strategy. In fact, some of the largest market cap firms have successfully harnessed the power of data for quite some time.  To illustrate this point, the Economist boldly published an article entitled “The world’s most valuable resource is no longer oil, but data.”  This makes complete sense when research shows that 90% of all data today was created in the last two years, which translates to approximately 2.5 ...

In a major decision sure to provoke controversy and legislative attempts to overrule it, the en banc Seventh Circuit, by a vote of 8 to 4, has held in Kleber v. CareFusion Corp., (No. 17-1206, Jan 23, 2019), that Section 4(a)(2) of the federal Age Discrimination In Employment Act ("ADEA") does not provide rejected external applicants with a cause of action.

The case was brought by Dale Kleber, a 58 year old applicant who applied for a position at CareFusion. The job description allegedly “required applicants to have ‘3 to 7 years (no more than 7 years)’” of relevant experience.

The ...

On December 11, 2018, the Food and Drug Administrative (“FDA”) issued a draft guidance for comment entitled, “Biomarker Qualification: Evidentiary Framework” (the “Guidance”).  The Guidance provides insight regarding standards for biomarker qualification under the 21^st Century Cures Act (“Cures Act”).

FDA defines the term “biomarker” as a “characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” There are various ...