In this episode of the Diagnosing Health Care Podcast:  In celebration of the 50th episode of our Diagnosing Health Care podcast, we’re looking at how the past 50 years of health law will impact health care in the next 50 years.

On this episode, Epstein Becker Green attorneys Mark LutesLynn Shapiro SnyderTed Kennedy, Jr.; and Nivedita Patel talk about the past, present, and future solutions to a fundamental question: How can the United States manage health care spending while continuing to provide access to high-quality health care products and services?

Continue Reading <em>Video:</em> Health Care’s Past, Present, and Future – <em>Diagnosing Health Care Podcast</em>

In September of this year, New York City Councilwoman Julie Menin announced her plan to introduce a series of bills that would create further price transparency requirements for hospitals, with noncompliance resulting in high financial penalties.

The bill package would create an office of hospital accountability that would inform the public as to how much hospitals are charging for various services via a price transparency information portal, where hospitals would be required to provide certain key pricing information to the public. Currently, such pricing data is not typically available for public access, and patients typically have little knowledge regarding how much they will be charged for services. Continue Reading Pending New York City Legislation Would Create Further Price Transparency Requirements for Hospitals, and Impose Severe Penalties for Noncompliance

It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute. Continue Reading Four Years After EKRA: Reminders for Clinical Laboratories

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: Continue Reading DOJ Further Revises Corporate Criminal Enforcement Policies: Focusing on Individual Accountability, Corporate Responsibility, and Additional Demands on Chief Compliance Officers

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. Continue Reading Unpacking Averages: Using Natural Language Processing to Extract Quality Information from MDRs

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?

Continue Reading <em>Podcast:</em> Hot Areas in COVID-19 Enforcement, Testing, and Funding – <em>Diagnosing Health Care</em>

In this episode of the Diagnosing Health Care Podcast:  Since the beginning of 2022, prices for construction services and materials have seen significant increases. How have these increases impacted the advancement of both new and ongoing health care construction projects?

On this episode of our Owner’s Outlook series, hear from special guest Clint Russell, Vice President of Capital Deployment – Construction and Equipment at HCA Healthcare.

Continue Reading <em>Podcast:</em> Owner’s Outlook: HCA’s Clint Russell on Health Care Construction Pricing and Innovation – <em>Diagnosing Health Care</em>

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.

Continue Reading No More Exceptions: What to Do When the California Privacy Exemptions for Employee, Applicant and B2B Data Expire

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? Continue Reading Unpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on Imports

Now on the Diagnosing Health Care Podcast:  The COVID-19 pandemic kicked off a pivot in health care construction and design, and acute care facilities have been rapidly renovating to adapt their spaces to evolving public health care needs.

Continue Reading <em>Podcast:</em> Owner’s Outlook: Maximize and Safeguard Reimbursement Through Design – <em>Diagnosing Health Care</em>