Health Law Advisor

On January 6, 2025, the U.S. District Court for the District of Massachusetts granted a defendant laboratory’s motion for summary judgment in a False Claims Act (FCA)/Anti-Kickback Statute (AKS) case brought by a physician objecting to the lab’s testing practices and its use of independent contractors paid on commission. Judge Patti B. Saris held that plaintiffs in FCA cases must establish that “but for” the payment of illegal remuneration in violation of the AKS, the claim would not have been submitted. Applying the “but-for” standard, Judge Saris dismissed OMNI Healthcare Inc. v. MD Spine Solutions LLC, et al. because the record did not support that the independent contractor status of some of the lab’s sales representatives or their conduct unduly influenced any provider’s decision to purchase the product.

Adoption of “But-For” Causation in FCA Cases

There is a circuit split regarding whether FCA plaintiffs must prove that “but for” the AKS violation, a claim would not have been submitted. Requiring “but-for” causation poses a significantly greater burden for plaintiffs seeking to advance FCA claims because they must show the kickback actually affected what good, item, or service was provided.

In the U.S. Courts of Appeals for the Sixth and Eighth Circuits, the heightened “but-for” causation must be established. The Third Circuit has adopted a less rigorous standard, requiring only a showing that at least one of the claims sought reimbursement for medical care that was provided in violation of the AKS. Plaintiffs in circuits with no clear precedent often argue for the application of the more plaintiff-friendly standards of the Third Circuit and use that ambiguity as leverage in negotiating settlement agreements.

On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill No. 5159, “An Act enhancing the health care market review process” (“H. 5159”), which was passed by the Massachusetts legislature in the last few days of 2024. The bill, which takes effect April 8, will implement greater scrutiny of certain health care entities and affiliated companies—including private equity sponsors, significant equity investors, health care real estate investment trusts (“REITs”), and management services organizations (“MSOs”)—as well as pharmaceutical companies and pharmacy benefit management companies (“PBMs”) in the Commonwealth. 

The passage of H. 5159 follows debate between the House and Senate earlier in 2024 over similar bills, which failed to pass during the summer legislative session. Notably, similar bills included debt limitations on certain private investor-backed entities and bans of certain private equity investments, as well as significant restrictions on the MSO business model. However, these restrictions (among various others) were stripped from H. 5159.

Although H. 5159 has widespread implications for health care entities in the Commonwealth, a significant portion of the bill is clearly aimed at increasing regulatory oversight of for-profit-backed health care organizations through increased regulatory oversight of certain health care transactions and expanded reporting obligations. The bill also seeks to contain health care costs, including by increasing oversight of pharmaceutical company and PBM arrangements.

On June 11, 2024, U.S. Senators Ed Markey and Elizabeth Warren from Massachusetts, introduced proposed legislation titled The Corporate Crimes Against Health Care Act (“CCAHCA”), aimed at addressing a perceived “looting” of health care systems by for profit private equity investors. According to Sen. Warren, the bill was introduced to “root out corporate greed and private equity abuse in the health care system,” “prevent exploitative private equity practices,” and to specifically ensure that actions such as “looting” do not happen again by addressing trigger events and targeting real estate investment trusts.

The CCAHCA proposes to impose significant criminal penalties, compensation clawbacks, and civil penalties against executives of private equity firms and health care entities that are found to have contributed to the death or injury of a patient through a triggering event. Additionally, the bill imposes certain requirements that impact real estate investments funds (REITs) and would require annual reporting requirements for change of control transactions.

2021 is set to be a landmark year for the number of jurisdictions raising wage floors across the country. According to a National Employment Law Project report, as of January 1, 2021, 20 states and 32 municipalities raised their minimum wage. By the end of 2021, the report tracks that as many as 24 states and 50 municipalities will increase wages for the lowest-paid workers.

Perhaps as a reaction to the steadily growing Fight for $15 movement or in response to the COVID-19 pandemic, 40 cities and counties will have met or exceeded a $15 minimum wage by the end of 2021. Eight states — ...

As discussed in our March 28, 2019 blog post, New Jersey adopted its own individual health insurance mandate, the   New Jersey Health Insurance Market Preservation Act (“NJHIMPA”).  The NJHIMPA requires, with certain qualifying exemptions, New Jersey residents to have minimum essential health coverage. New Jersey employers must verify health coverage information provided by individuals. To assist with employer reporting, New Jersey launched an official website with guidance on the filing requirements.

Recent updates to the official website, which was lasted updated on ...

Consumer privacy protection continues to be top of mind for regulators given a climate where technology companies face scrutiny for lax data governance and poor data stewardship.  Less than a year ago, California passed the California Consumer Privacy Act (CCPA) of 2018, to strengthen its privacy laws.  In many regards, the CCPA served as a watershed moment in privacy due to its breadth and similarities to the E.U. sweeping General Data Protection Regulation (GDPR) law.

Yet, California continues to push the envelope further.  Recently, California State Senator Jackson and Attorney ...

Beginning July 1, 2018, recreational marijuana can be legally sold, taxed, and consumed in Massachusetts—one of nine states, in addition to Washington, D.C., that now permits recreational marijuana use. Massachusetts already is one of 29 states that allow marijuana use for medicinal purposes (and 17 others permit certain low-THC cannabis products for medical reasons).

Background

Legalization of recreational marijuana started in 2016 with a ballot initiative by Massachusetts voters. The Regulation and Taxation of Marijuana Act (“Marijuana Act”), which took effect on ...

Our colleagues Patrick G. Brady and James J. Sawczyn, at Epstein Becker Green, have a post on the Retail Labor and Employment Law blog that will be of interest to many of our readers in the health care industry: “New Jersey’s Appellate Division Finds Part C of the “ABC” Independent Contractor Test Does Not Require an Independent Business”

Following is an excerpt:

In a potentially significant decision following the New Jersey Supreme Court’s ruling in Hargrove v. Sleepy’s, LLC, 220 N.J. 289 (2015), a New Jersey appellate panel held, in Garden State Fireworks, Inc. v. New ...

Connecticut employees using medical marijuana for certain debilitating medical conditions as allowed under Connecticut law for “qualified users” are protected under state law from being fired or refused employment based solely on their marijuana use. Employers who violate those protections risk being sued for discrimination, according to a recent federal district court decision.

Background

In Noffsinger v. SSC Niantic Operation Company (3:16-cv-01938; D. Conn. Aug. 8, 2017), the federal district court ruled that “qualified users” are protected from criminal ...

The U.S. Court of Appeals for the Second Circuit recently clarified that the “motivating factor” standard of causation applies to Family and Medical Leave Act (FMLA) retaliation claims, instead of the “but for” causation standard applied in Title VII and ADEA retaliation cases. The “but for” standard is more onerous for the plaintiff, who must demonstrate that discrimination or retaliation was the determining factor for the adverse employment action, not just one reason among others. The less burdensome “motivating factor” causation standard requires the ...

With flu season quickly approaching, health care employers may be considering mandatory influenza vaccinations for their workforce. Mandatory vaccination policies may dramatically increase patient safety, but they may also cause friction within the workforce when employees object on religious grounds to being vaccinated.

While no federal and few state statutes address the legality of enforcing mandatory vaccination policies, the EEOC and private litigants recently have moved this issue forward in the courts. Under Title VII of the Civil Rights Act of 1964 (“Title ...