As the regulation of artificial intelligence (AI) tools in healthcare settings rapidly evolves, state medical boards and related agencies are at the forefront of development and enforcement. While some states have taken...more
Signaling a possible future approach to regulating Schedule II-V prescribing via telemedicine in lieu of in-person examinations, on January 17 the DEA issued a notice of proposed rulemaking regarding its next iteration of...more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also...more
The Artificial Intelligence in Healthcare Services Bill, signed into law by Governor Gavin Newsom, imposes new requirements on California healthcare providers that use generative artificial intelligence tools to generate...more
The Centers for Medicare & Medicaid Services (CMS) published its Final Rule today to implement a minimum staffing “floor” for nursing homes in the United States, as first announced on April 22. The Final Rule, which as...more
As noted in our recent LawFlash, the US Department of Justice’s (DOJ’s) COVID-19 Fraud Enforcement Task Force (CFETF) recently released its annual compilation report of its efforts to combat fraud related to pandemic relief...more
While private equity (PE) investments in healthcare have long been subject to scrutiny, as PE investment in healthcare has grown sizably over the last decade, so too has the concern from federal and state regulatory bodies...more
The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued long awaited updates to the regulations at 42 CFR Part 2...more
The Medicare program is broken down into four parts. Part A covers the cost of healthcare items and services provided during inpatient hospital stays as well as skilled nursing facility, hospice, and some home health care....more
If you have had a loved one suffer from dementia, you know the emotional, physical, and financial toll of this terrible disease. With advancements in dementia treatment, however, there is renewed hope on addressing this...more
The US Department of Justice (DOJ) Civil Division released its annual fraud statistics on February 22, highlighted by False Claims Act (FCA) settlements and judgments exceeding $2.68 billion in fiscal year 2023. DOJ released...more
The Health Care Fraud and Abuse Control Program (HCFAC), an annual report jointly issued by the US Department of Justice (DOJ) and Department of Health and Human Services (HHS), can be helpful in predicting DOJ and HHS...more
Digital health—that is, medical care enhanced or made possible by the use of technology—has changed the landscape of healthcare in America. Innovation in this sector is at an all-time high and 2024 will no doubt see greater...more
The US Centers for Medicare & Medicaid Services (CMS) has implemented a final rule, effective November 13, 2023, designed to enhance the oversight of hospice providers throughout the United States and increase regulatory...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently released Advisory Opinion No. 23-07, in which OIG approved a proposed arrangement to pay employed physicians bonuses based on net...more
The US Drug Enforcement Administration (DEA) issued a temporary rule on October 6, 2023 extending COVID-19–era flexibilities through December 31, 2024. With this extension, the DEA will continue to waive provisions under the...more
If your organization has faced a Medicare audit in the last decade, you may have experienced a significant delay in the Medicare appeals process due to a monumental backlog of claims pending in front of administrative law...more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
Healthcare providers are scrambling to understand the impacts of the May 11 expiration of the COVID-19 public health emergency (PHE). Luckily for most telehealth providers, the outlook of their operations post-PHE is...more
Key provisions that provided flexibility to long-term care providers and helped alleviate administrative burdens will expire May 11, 2023. Long-term care facilities (LTCs), skilled nursing facilities (SNF), and nursing...more
Throughout the COVID-19 pandemic and related public health emergency (PHE), the US Department of Health and Human Services, Office for Civil Rights (OCR) issued four Notifications of Enforcement Discretion (referred to as...more
COVID-19 significantly affected home-based care providers, such as home health agencies (HHAs) and hospices, whose staff had to overcome both physical and mental burdens of going into patients’ homes to deliver care,...more
In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more
The Consolidated Appropriations Act of 2023 (CAA), the massive $1.7 billion spending bill signed into law on December 29, 2022, had a number of important healthcare “gems” included. A critical provision for substance use...more