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.Continue Reading Healthcare Policy in 2024: What’s Next?

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, aware all the while that their profit-seeking came at the expense of their patients’ health.”

Yiulu Ruan was convicted in the Southern District of Alabama of conspiring to unlawfully distribute controlled substances, unlawfully distributing controlled substances, and other offenses, and was sentenced to twenty one years and two months imprisonment.  His conviction was affirmed by the Eleventh Circuit.  Shakeel Kahn was convicted in the District of Wyoming of conspiring to dispense and distribute controlled substances resulting in death, unlawfully dispensing controlled substances, and other offenses, and was sentenced to twenty five years imprisonment.  His conviction was affirmed by the Tenth Circuit.
Continue Reading Supreme Court To Hear Argument Addressing Doctors’ Good Faith Defense To Pill Mill Prosecutions

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 facts about New York State’s adult-use and medical cannabis programs. These facts, and more information on the cannabis program in New York, can be found at the websites listed at the end of this post.
Continue Reading CANNABIS IN NEW YORK STATE: JUST THE FACTS

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 issued orders suspending or severely curtailing operations of certain businesses.   In its complaint, Northwell alleged that, while caring for over 100,000 COVID-19 patients, it incurred significant new costs, was forced to cease elective surgeries and close physicians’ practices, and saw fewer hospital admissions and visits.  Northwell alleged that the respiratory droplets carrying the coronavirus were “physical objects, carrying a physical substance, that attach to [and] cause harm to property.”  Examining several different policy provisions, the Court held that Northwell had failed to establish an entitlement to coverage.
Continue Reading Northwell Loses Bid For COVID-19 Insurance Coverage

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, distributors, dispensers or promoters of opioids on claims arising from the manufacture, distribution, dispensing or promotion of opioids and (ii) any judgment, decree or other resolution of claims against those and “related” entities “arising out of activities alleged to have contributed to increases in opioid addiction.”  Finance Law, §99-nn(4).  OSF monies will include the proceeds of these claims, whether the claims were filed or unfiled, actual or potential, legal or equitable.  Id. 

The NYS Comptroller and NYS Commissioner of Taxation will be joint custodians of the OSF.  OSF monies are required to be segregated and not commingled with any other funds held by the Comptroller.  Finance Law §99-nn(2).  OSF expenditures “shall be used to supplement and not to supplant or replace” any other federal or NYS funds which would other otherwise be used for substance use prevention, treatment, recovery and harm reduction services. Finance Law §99-nn(3).  The law specifies that general operating funds or baseline funding for substance use prevention, treatment and recovery will not be reduced due to amounts expended from OSF.  Id.  All amounts received by the OSF will remain there “unless and until directed by statute or appropriation.”  Finance Law, §99-nn(4).  Funding must be disbursed to provide adequate geographic distribution across NYS.  In addition to programs administered by the Office of Addiction Services and Supports (OASAS), OSF dollars may be used for programs of NYS agencies other than OASAS which oversee programs and services that are considered eligible OSF expenditures.  §99-nn(5).  Local governments and school districts may apply for OSF funding to the appropriate NYS agency. Mental Hygiene Law, §25.18(b).
Continue Reading New York Establishes an Opioid Settlement Fund

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, and ancillary staff providing direct patient care, and up to fifty percent (50%) of hospital administrators, including, but not limited to, the chief financial officer, the chief nursing officer, and patient care unit directors or managers or their designees.  The staffing committees shall create staffing plans with guidelines as to how many patients are assigned to each nurse, as well as how each unit is staffed with ancillary staff, based on patient needs and ratios, matrices or grids, which shall be used as the primary component of the general hospital staffing budget, provided that such staffing plans meet or exceed the terms of existing collective bargaining agreements.

The staffing committees are charged with the development of the staffing plans, and hospitals shall then adopt and submit the plans to the New York State Department of Health (“DOH”) by July 1, 2022.  The staffing plans must be reviewed internally semiannually, updated annually by July 1, and implemented thereafter by January 1 of the following year.  In addition, the staffing plans must be posted in publicly conspicuous areas in each patient unit of hospitals, and on the DOH hospital profile website.  The staffing committees are also charged with review, assessment and response to complaints regarding potential violations, staffing variations or other concerns.
Continue Reading New York State Approves Establishment of Clinical Staffing Committees in General Hospitals

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

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,

On June 11, the New York Court of Appeals, in Andrew Carothers, M.D., P.C. v. Progressive Insurance Company, 2019 NY Slip Op 04643, decided that an insurer may withhold payment for services provided by a medical services corporation improperly controlled by non-physicians whether or not the medical services corporation acted fraudulently or with fraudulent