Recently, in United States ex rel. Hart v. McKesson Corp., the Second Circuit clarified the standard for acting “willfully” under the federal anti-kickback statute (AKS). False Claims Act relator Adam Hart alleged that the defendant violated the AKS by providing business management tools to its customers, without charge, to induce those customers to purchase drugs from them.  The tools helped providers to maximize profits and mitigate the risk that reimbursement rates would fall below the cost of the drugs to them.  One tool, the Margin Analyzer, compared profit margins for drugs con ..read more

On January 9, 2024, the federal Centers for Medicare and Medicaid Services (CMS) finally approved New York State’s 1115 waiver amendment to establish the New York Health Equity Reform (NYHER) Program. That application, which is the successor to the state’s Delivery System Reform Incentive Payment (DSRIP) Program that expired in March 2020, was first described in a concept paper issued by the Department of Health (DOH) in August 2021, and was filed with CMS in September 2022. The approved waiver amendment, which expires on March 31, 2027, includes most of the features included in the ..read more

As we head into a new calendar year, in the healthcare space it is worth reflecting on the events of the last few years, as a means of predicting what is likely to come.  Last year, the focus in healthcare policy was very much on what will come after COVID; this year, we finally have the opportunity to review what that is.  And we can confidently say that 2024 is likely to see a continuation of many of the trends in healthcare policy that we saw in 2023. Probably the most significant will, paradoxically, be a continued focus on things outside of, but nonetheless important to, healthc ..read more

The Supreme Court will hear argument next week in two consolidated cases that will decide what standard applies when a doctor asserts a good faith defense to a criminal prosecution for unlawful drug distribution.  The argument on Tuesday, March 1, will address the convictions of two doctors accused of running “pill mills” and seeking to profit in the midst of the national opioid crisis.  According to the Government, “the petitioners simply cloaked themselves in medical garb while acting as drug dealers, lining their own pockets by dispensing addictive, dangerous, and lethal drugs, aw ..read more

On March 31, 2021, Governor Andrew Cuomo signed the Marihuana Regulation & Taxation Act (MRTA) legalizing adult-use cannabis in New York State. In doing so, New York became the 15th state in the United States to legalize cannabis use. As  a result of the enactment of the MRTA, New York established the Office of Cannabis Management (OCM). The OCM will regulate and control the cultivation, processing, manufacture, distribution, transportation, and sale of cannabis in New York. This includes medical cannabis, adult-use or “retail” cannabis and cannabinoid hemp. Below we’ve gathered key ..read more

SDNY Judge Jed Rakoff rejected Northwell Health’s bid for insurance coverage for its increased costs and business losses related to the COVID-19 pandemic in a recent decision.  As the COVID-19 pandemic unfolded, Northwell was inundated with new patients, had increased cleaning costs, and stopped offering outpatient care services and elective procedures.  In the ruling, Judge Rakoff held that Northwell was not entitled to coverage under two all-risks commercial property insurance policies. The federal government declared a COVID-19 emergency on March 13, 2020, and New York State issue ..read more

By legislation enacted last month, on June 9, 2021, amending the New York Finance Law, Mental Hygiene Law and Executive Law, New York State established an opioid settlement fund (“OSF”).  Finance Law §99-nn(1).  The purpose of the OSF and the OSF advisory board created by the statute is to ensure that all opioid settlement monies are dedicated to the prevention and treatment of substance use disorders, and the recovery of substance use victims.  OSF will include money paid to NYS as the result of (i) the settlement or other resolution of litigation against manufacturers, distrib ..read more

In continuing efforts to address problems exposed by the COVID-19 pandemic, on June 18, 2021, the Governor signed legislation (S.1168-A/A.108-B) into law to address an urgent public policy priority related to clinical staffing in hospitals licensed pursuant to Article 28 of the New York State Public Health Law.  This legislation requires the establishment of clinical staffing committees to create plans to more effectively distribute staff throughout general hospitals.  The staffing committees must consist of at least fifty percent (50%) of registered nurses, licensed practical nurses ..read more

In recent months, there has been a lot of attention on decisions made during the height of the COVID-19 pandemic in New York State in regard to nursing homes.  Some of that attention has focused on an order issued in the early days of the pandemic requiring nursing homes to readmit COVID-positive residents previously referred to hospitals, at a time when one of the State’s primary concerns was potential hospital overcrowding.  Even more attention has been paid to the fallout from that order, including not only the consequent outbreaks in impacted nursing homes and resulting deaths, b ..read more

As policymakers have responded to the COVID pandemic, they have implemented a variety of changes that create tremendous opportunities in the post-COVID world.  Perhaps the most significant of these is in the area of telehealth.  The remote delivery of healthcare and health-related services has tremendous implications for patient access to care and quality of outcomes, and stakeholders across the country are actively examining how best to leverage telehealth technology to achieve those goals. Nowhere is this truer than in New York State.  Before COVID, New York, like many states ..read more