Insights

On March 27, 2025, HHS announced a “dramatic restructuring” of its various agencies and offices in accordance with President Trump's Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” HHS also published a Fact Sheet.

The United States Court of Appeals for the First Circuit issued a pivotal ruling earlier this week, finding that in order to establish falsity in a False Claims Act (“FCA”) case premised on Anti-Kickback Statute (“AKS”) liability, the kickback must have been the “but-for” cause of the submission of the claim. The court’s decision hinged on the meaning of the phrase “resulting from” within the 2010 amendment to the AKS, which provided that a claim that includes items or services “resulting from” a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA. The meaning of “resulting from” for purposes of establishing such FCA liability has been hotly debated by courts. The First Circuit now joins the Sixth and Eighth Circuits in adopting this stricter but-for standard, while the Third Circuit has opted for a much looser approach.

On May 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) published a Final Rule that, for the first time, imposes national minimum nurse staffing requirements for nursing homes. Specifically, the standard adopted by CMS requires minimum staffing of 3.48 hours per resident day (“HPRD”), as discussed in more detail below. CMS estimates that the new requirements will cost facilities $43 billion over the next 10 years, which is more than the $40.6 billion cost that CMS estimated for Proposed Rule of 3.0 HPRD. Some industry sources estimate that less than 25% of nursing facilities across the country currently meet the full scope of staffing standards laid out in CMS’ Final Rule due to a myriad of factors including labor shortages and increasing wage pressures. Indeed, the impact and cost of these staffing requirements will vary significantly by state. For example, CMS reported that at least one state will need to increase certain staff by nearly 96% to meet the minimum standards, while other states already meet the requirements.

The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective compliance program that health care entities have long relied upon. The new guidance also includes recommendations to conduct annual internal risk assessments, to consider quality of care as a component of the compliance program, and to emphasize the importance of a board’s and executive leadership’s oversight of compliance.

An amendment to New York’s Certificate of Need (CON) law, set to go into effect on June 22, 2023, will require every CON application to include a “health equity impact assessment.”  The new law, N.Y. Public Health Law § 2802-b, requires an assessment be prepared by an independent entity that addresses whether, and if so how, “a project will improve access to hospital services and health care, health equity and reduction of health disparities.” The assessment must also make “particular reference to members of medically underserved groups, in the applicant’s service area.” Importantly, this new requirement does not apply to CON applications filed before June 22, 2023. To date, the Department of Health (DOH) has not yet issued implementing regulations.

On July 29, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates Medicare payment policies and rates for skilled nursing facilities (SNFs) and enacts changes to the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program beginning in FY 2023.

Last week, the Centers for Medicare & Medicaid Services (CMS) released data—for the first time—reporting on mergers, acquisitions, consolidations, and changes of ownership of Medicare enrolled hospitals and nursing homes over the past six years. This data, expected to be updated on a quarterly basis moving forward, has been lauded as an important step in improving transparency around nursing facility ownership and enhancing nursing home safety and quality of care. In conjunction with the release of CMS’ data, HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a related report analyzing the data and examining trends in changes of ownership over the past six years. In its report, ASPE also offers preliminary insights into how the data on ownership changes can support implementing policies bolstering competition in health care as well as ensuring program integrity in Medicare and Medicaid.

The 11th Circuit upheld a decision to unseal “embarrassing internal communications” between members of the United Network for Organ Sharing (“UNOS”) relating to its new policy directing liver transplants to go to the sickest patients within a certain radius of the donor.

The Federal Circuit affirmed a finding of indefiniteness based on a patent owner’s materially conflicting positions adopted during prosecution on the scope of its claims.

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a formal work plan this November that includes a review in the 2021 fiscal year aimed at determining the extent to which nursing homes are complying with regulatory requirements relating to facility-initiated discharges.

On June 30, 2020, in U.S. Patent and Trademark Office v. Booking.com, the Supreme Court of the United States held 8-1 that “Booking.com” can function as a trademark eligible for federal registration because consumers perceive the term to identify the hotel-reservation services available at that domain name. The Court affirmed the Fourth Circuit holding that the term is not, as the United States Patent and Trademark Office (USPTO) had previously found, “a generic name for online hotel-reservation services.”

On May 21, 2020 the U.S. Copyright Office published its highly anticipated report about Section 512 of Title 17 of the United States Code. The aim of the report was to determine, in light of the monumental changes the Internet has undergone since the days of dial-up and floppy disks, whether Section 512 continues to work “effectively in achieving its aim of balancing the needs of online service providers (OSPs) with those of creators.” The Copyright Office’s report marks the first time the government has studied the effectiveness of the controversial Section 512 since it was enacted more than 20 years ago. As noted by the Copyright Office, “[t]he proper balance of intermediary safe harbors and liability online is a topic on which few stakeholders have no opinion, and passions (as well as rhetoric) run high on all sides.”

On May 18, 2020, CMS published new guidance to assist with efforts to safely “reopen” nursing homes nationwide. In the context of nursing homes, “reopening” means permitting visitors and other non-essential personnel to enter the nursing facility. For much of the coronavirus pandemic, residents have been separated from family and friends—who often are a source of comfort to residents and integral to their quality of life and psychological well-being. Some facilities have improvised opportunities for connection remotely via social media and other technology platforms. Given the heightened risks COVID-19 presents to frail elderly, however, reopening nursing homes does not appear on the horizon. 

The USPTO announced that it was further extending the deadline for individuals to file certain patent and trademark related documents and to pay certain fees, pursuant to its authority under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

Across the globe, countries scramble to enforce social distancing and other emergency safety measures in attempts to reduce the spread of COVID-19. During this uncertain time, it is important for those who hold worldwide intellectual property portfolios to be aware that the impact of the pandemic on the operations of patent and trademark offices worldwide has varied substantially. While some offices have offered relief to those impacted by the outbreak by automatically extending deadlines, other offices have closed and postponed all operations indefinitely for the duration of the outbreak. Below is a summary of how intellectual property offices around the world will operate amidst the pandemic. This information will be updated to reflect any updates from the intellectual property offices and can be found at Crowell & Moring’s Coronavirus Resource Center.

Last week, the U.S. Court of Appeals for the Federal Circuit, in In Re: Forney Industries, Inc., held that a multicolored mark, when used on product packaging, can be inherently distinctive, and thus eligible for federal trademark registration. The proposed mark consisted of the use of black next to a yellow to red color spectrum as shown below on tools and accessories for welding:

The U.S Patent and Trademark Office (USPTO) announced several initiatives aimed at providing relief for those impacted by the COVID-19 public health emergency.

Hospitals and providers across the country now have greater ability to leverage digital communications technology to provide telehealth services during the COVID-19 public health emergency. The Department of Health and Human Services (HHS) exercised emergency authorities to waive certain restrictions applicable to Medicare and Medicaid under Section 1135 of the Social Security Act. The new waivers issued over the last several days both expand telehealth benefits and allow greater flexibility in the manner telehealth is used by physicians and practitioners to address patient care needs.

On December 30, 2019, New York State Governor Cuomo signed S4278, amending the state’s Business Corporation Law in order to conduct a study of the number of women who serve on boards of directors of business corporations. The New York Department of State, in collaboration with the Department of Taxation and Finance, will now require all domestic and foreign business corporations authorized to do business in the state to report the number of women who serve on their board of directors on their Biennial Statement filed with the Department of State. By February 1, 2022, the Department of State will publish a report on the findings of this study on its website, and continue doing so every four years thereafter. The study will include the number of women directors and the total number of directors that constitute the board of each corporation, an analysis of the change in number of women directors from previous years, and the aggregate percentage of women directors on all such boards of directors.

On December 16, 2019, Governor Cuomo signed into law legislation amending the New York Public Health Law to add a new section (§2803-x) imposing significant reporting obligations on nursing home operators and increasing New York State Department of Health (DOH) oversight over various transactions involving nursing homes.