Health Law Advisor

Building on attempts in recent years to strengthen the Department of Justice’s (DOJ’s) white collar criminal enforcement, on September 15, 2022, Deputy Attorney General Lisa Monaco announced revisions to DOJ’s corporate criminal enforcement policies. The new policies, and those that are in development, further attempt to put pressure on companies to implement effective compliance policies and to self-report if there are problems. Notably, the new DOJ policies set forth changes to existing DOJ policies through a “combination of carrots and sticks – with a mix of incentives and deterrence,” with the goal of “giving general counsels and chief compliance officers the tools they need to make a business case for responsible corporate behavior” through seven key areas:

Over the spring and summer, I did a series of posts on extracting quality information from FDA enforcement initiatives like warning letters, recalls, and inspections.  But obviously FDA enforcement actions are not the only potential sources of quality data that FDA maintains.  FDA has what is now a massive data set on Medical Device Reports (or “MDRs”) that can be mined for quality data.  Medical device companies can, in effect, learn from the experiences of their competitors about what types of things can go wrong with medical devices.

The problem, of course, is that the interesting data in MDRs is in what a data scientist would call unstructured data, in this case English language text describing a product problem, where the information or insights cannot be easily extracted given the sheer volume of the reports.  In calendar year 2021, for example, FDA received almost 2 million MDRs.  It just isn’t feasible for a human to read all of them.

That’s where a form of machine learning, natural language processing, or more specifically topic modeling, comes in.  I used topic modeling last November for a post about major trends over the course of a decade in MDRs.  Now I want to show how the same topic modeling can be used to find more specific experiences with specific types of medical devices to inform quality improvement.

In this episode of the Diagnosing Health Care Podcast:  While the COVID-19 pandemic seems to be moving into our rearview mirror, government investigations and enforcement actions targeting COVID-19-related fraud are just starting to heat up.

What can businesses do to prevent or mitigate potential civil and criminal charges in this area?

The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) gives consumers increasingly more control over their personal information when collected by businesses subject to the law. We have previously discussed the compliance requirements of these data privacy laws on organizations doing business in California.[1] Significantly, CCPA/CPRA defines the term “consumer” to mean any California resident; which from a business perspective, such a broad definition encompasses not only the business’s individual customers, but also its employees, job-applicants or even business-to-business (B2B) contacts.  With the moratoriums currently in place for B2B and employee/applicant data sunsetting on January 1, 2023 and not likely to be extended, and the prospect for federal data privacy legislation with wide preemptive effect of state law looking less likely, businesses should be actively preparing to meet these expanded statutory obligations.

A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region.  Such a government initiative would significantly deter investments in the companies doing the importing.  Turns out, the agency was not.  The FDA’s recent activities in the region were well within their historical norms.

But the project got us thinking, what does the agency’s enormous database on import actions tell us about the agency’s enforcement priorities more generally?  There are literally thousands of ways to slice and dice the import data set for insights, but we picked just one as an example.  We wanted to assess, globally, over the last 20 years, in which therapeutic areas has FDA been enforcing the 510(k) requirement most often?

From the Diagnosing Health Care Podcast:  How have complaints of information blocking been submitted to the Office of the National Coordinator (ONC), and by whom? What does government enforcement action really look like?

In this episode of our special series on interoperability, hear from ONC attorneys Cassie Weaver and Rachel Nelson.

On August 19, 2022, the Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 22-16 (“AO 22-16”) to its website, a favorable opinion concluding that the OIG would not impose sanctions in connection with a program that offered $25 gift cards to Medicare Advantage (“MA”) plan enrollees who completed an online educational program about the potential risk, benefits, and expectations related to surgery. AO 22-16 is the latest in a string of recent OIG advisory opinions addressing arrangements involving remuneration to Federal health care program beneficiaries - the ninth such advisory opinion in 2022 alone.

The company that requested this advisory opinion contracts with Medicare Advantage Organizations (“MAOs”) to offer the educational program to MA plan enrollees and charges the MAOs a per-member, per-month fee for the program. MA plan enrollees who take the educational program and complete a survey receive a $25 gift card, which may be for a big box store or online retailer that offers a wide variety of items. The company that offers the educational program sends mailings and email correspondence to MA plan enrollees about the educational program but does not advertise or market the program to individuals who are not enrollees of a MA plan that has contracted with the company. The MAOs are prohibited by their contract with the company from including information about the gift cards offered under the program in marketing materials to prospective enrollees.

As we reported, the Los Angeles City Council approved a new healthcare worker minimum wage ordinance, increasing the minimum wage for healthcare workers at private healthcare facilities in Los Angeles to $25.00 per hour. Similarly, the Downey City Council approved its own citywide healthcare worker minimum wage ordinance. For the moment, however, both ordinances are on pause. The Los Angeles ordinance would have gone into effect on August 13, 2022, and the Downey ordinance would have become effective on August 11, 2022.

In this episode of the Diagnosing Health Care Podcast:  For years, pharmacy advocates have urged policymakers to make changes to state scope of practice laws that would permit pharmacists to prescribe and administer certain tests and vaccines at the pharmacy. How has COVID-19 impacted these efforts?

Hear from special guest Will Chang, Chief Legal Officer of UpStream.

On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]