Health Care

On March 28, 2024, the Biden-Harris Administration released final rules intended to lower health care costs and protect consumers from being induced into purchasing so-called “junk insurance” policies (the “Final Rules”).[1] According to the press release, the Final Rules are intended to close loopholes that have permitted “junk insurance” issuers to mislead consumers into buying highly restricted and discriminatory plans that provide inadequate coverage when consumers need it the most. The Final Rules primarily realign federal definitions with intended scopes of coverage and increase transparency to allow consumers to make informed, beneficial choices about their health coverage for enhanced
Continue Reading Closing the Loopholes: The Biden-Harris Administration’s Action Against “Junk Insurance”

Last month, the Federal Trade Commission (“FTC”) hosted its annual PrivacyCon event, featuring an array of experts discussing the latest in privacy and data security research. This post, covering healthcare privacy issues, is the first in a two-part series on PrivacyCon’s key takeaways for healthcare organizations. The second post will cover topics on artificial intelligence in healthcare.
Continue Reading Healthcare Highlights from FTC’s 2024 PrivacyCon

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug and biosimilar competition. In the case, Teva asserts that Amneal’s Abbreviated New Drug Application (“ANDA”) for an asthma inhaler infringes upon five patents it has listed in the FDA’s Orange Book–a challenge that under FDA regulations triggers a 30-month stay of FDA’s approval of the generic inhaler. Amneal’s counterclaims assert that the Teva patents, which relate to the inhaler device and dose counter, rather than
Continue Reading FTC’s Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

On March 28, 2024, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced that it is extending the temporary special enrollment period (the Unwinding SEP) for prior beneficiaries of Medicaid and Medicaid-expansion Children’s Health Insurance Programs (CHIP) to enroll in the Health Insurance Marketplace (Marketplace). The Unwinding SEP was previously scheduled to terminate on July 31, 2024, but now the end date is extended to November 30, 2024. This 4-month extension will help millions maintain insurance coverage as they navigate their new post-pandemic eligibility statuses.
Continue Reading Continuity in Coverage: CMS Extends the Unwinding SEP & Issues Final Rule for Medicaid and CHIP Enrollment

The research is clear. A good decision with a bad outcome is likely to be viewed – by others and by the decision-makers themselves – as a bad decision in hindsight. Equally so, a bad decision with a good outcome is likely to be viewed as a good decision in hindsight. Both views, however, are wrong – and, if allowed to persevere unchecked, can lead to all manner of flawed decisions going forward.

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Continue Reading Organizational Integrity Shorts: Good Plans that go Awry or why we Conflate Bad Outcomes with Bad Decisions

“The American people deserve to know that the insurance companies receiving more than $700B annually in taxpayer funds are working to ensure you receive effective, high-quality care. Remember, you have rights and options to ensure you receive the care you deserve.”
Continue Reading OIG Sparks Public Excitement about Managed Care and Alludes to Incoming Enforcement Guidance

Let’s say you’re a publicly traded manufacturer of a popular medical device, which you sell commercially as well as to a number of VA hospitals. You receive an anonymous internal hotline complaint alleging that certain unauthorized, reverse-engineered components were used in the manufacturing process and that certain quality tests were skipped in the interest of “efficiency.” You triage the complaint, do your preliminary diligence, determine the complaint isn’t frivolous, and launch a privileged internal investigation.
Continue Reading Organizational Integrity Shorts: Don’t Just Let the Dominoes Fall; Understand the Paths They Might Take

I. Alabama Legislation Following LePage

On March 7th, the Alabama Legislature passed SB159 (“SB159” or the “bill”), as a means of granting certain protections to IVF clinics and providers in the wake of the LePage v. Center for Reproductive Medicine decision. The bill among other things, grants civil and criminal immunity to any individual or entity in connection with death or damage to an embryo when providing or receiving services related to in vitro fertilization (“IVF”). The protections afforded by SB159 apply to (i) manufacturers of goods used to facilitate the IVF treatments and (ii) individuals engaged in the transportation of the
Continue Reading IVF Caught in the Crosshairs: The Aftermath of the LePage Decision

The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2 (Part 2).
Continue Reading HHS Announces 42 Part 2 Final Rule to Align with HIPAA

On March 5, 2024, the Federal Trade Commission (“the FTC”) hosted a public workshop titled “Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care”, which covered the impact of private equity investment on the health care system. The workshop included panelists from the FTC, the Department of Justice (“the DOJ”), the Department of Health and Human Services (“HHS”) (together, “the Agencies”), academic thought-leaders, and health care professionals. On the same day as the workshop the Agencies launched a “Cross-Government Inquiry on Impact of Corporate Greed in Health Care,” issuing a Request for Information (“RFI”)
Continue Reading The FTC Hosts Workshop on Private Equity in Health Care

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) concerning pharmaceutical manufacturers’ offers of cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries. The opinion under review was Advisory Opinion No. 22-19,[1] which we previously wrote about[2] and in which the OIG advised that if pharmaceutical manufacturers offered the proposed cost-sharing subsidies to Part D beneficiaries via PCPA, they could be subject to
Continue Reading District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

Too often people argue as though they are in front of a judge, or some other cosmic arbiter of correctness, rather than asking ourselves what might move our opponent. In this edition of OIG Shorts, the Sheppard Mullin Richter & Hampton LLP Organizational Integrity Group explains that to increase our chances of moving our opponent, we need to recalibrate our goals, rethink our strategy, and reframe the discussion.
Continue Reading Organizational Integrity Shorts: The Science of Persuasion

On Tuesday, January 9, 2024, the Centers for Medicare & Medicaid Services (“CMS”) approved a request from New York State (“NYS”) to amend its Medicaid section 1115(a) demonstration (the “Demonstration Amendment”),[1] which will allow for important expansion of the NYS Medicaid program, including:
Continue Reading 2024 Brings Expansion to Medicaid in New York State

Investigations are stressful for an organization’s leadership. But what is often overlooked is that they are stressful for an organization’s employees as well. The need-to-know nature of internal investigations usually restricts knowledge of the investigation’s character, scope, and potential consequences to a relatively small circle of senior management. But the employees who fall within the scope of the investigation will often know little about what’s going on, which can generate anxiety, impair morale, and create tensions in the workplace, further leading to negative repercussions for the organization that persist long after the investigation has been closed.
Continue Reading The Close-Out Debrief