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>

From the Diagnosing Health Care PodcastHow 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.

Continue Reading <em>Podcast:</em> Interoperability: Information Blocking Claims and Enforcement – <em>Diagnosing Health Care</em>

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. Continue Reading OIG Approves Gift Cards for Medicare Managed Care Enrollees Who Complete Online Education

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.

Continue Reading <em>Podcast:</em> Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act – <em>Diagnosing Health Care</em>

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]

Continue Reading Biden Administration Seeks to Clarify Patient Privacy Protections Post-<em>Dobbs</em>, Though Questions Remain

From the Diagnosing Health Care Podcast:  Over the last 12–24 months, Critical Access Hospitals (CAHs) have seen steep cost escalation in their expansion and renovation plans, with expense increases exceeding 10 percent. Combined with nationwide staffing shortages, CAHs are at a crossroads as to how to proceed.

On this episode of our Owner’s Outlook series, hear from special guest Eric Shell, Chairman of Stroudwater Associates, a national advisory firm that designs solutions for rural and community hospitals.

Continue Reading <em>Podcast:</em> Owner’s Outlook: Renovating and Expanding Critical Access Hospitals in a Volatile Market – <em>Diagnosing Health Care</em>