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.

The doctors argue that the trial courts failed to properly instruct the juries on their good faith defenses.  Ruan concedes that a physician otherwise authorized to prescribe controlled substances may be convicted of unlawful distribution if his prescriptions “fall outside the usual course of professional practice.” United States v. Moore, 423 U.S. 122, 124 (1975).  He argues, however, that he should have been permitted to advance a subjective “good faith” defense, so that he could not have been convicted where in good faith, he “reasonably believed” or “subjectively intended” that his prescriptions fell within the usual course of professional practice.  Ruan argues that a physician may not be convicted unless acting without a good faith medical purpose, meaning that “a physician who believes in good faith that her prescription serves a valid medical purpose may not be convicted simply because her belief proves to be unpopular.”

The Government argues that the Court should not allow a subjective standard to supply the basis for a good faith defense.  The Government’s standard would allow a conviction where the doctor “did not even make an objectively reasonable attempt to ascertain and act within the bounds of professional medicine.”  The Government argues that a doctor cannot have a good faith belief that his practices fall within the usual course of professional practice unless he makes an objectively reasonable “honest effort” to ascertain and adhere to professional medical boundaries, and the “wholly subjective” views of a doctor should not preclude conviction.  Petitioners argue that their trial court jury instructions did not even meet this test, and their cases must be remanded for a new trial even under the Government standard.

The Supreme Court’s decision could be narrowly focused on the specific trial court instructions, or it could set a broader good faith standard either strengthening or seriously hampering Government efforts to prosecute doctors for unlawful drug distribution.  The March 1 argument will be on live audio starting at 10 am on the Supreme Court website.

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.

ADULT-USE MARIJUANA PROGRAM

  • Only adults 21 years of age or older may possess and use recreational cannabis.
  • Adults over 21 can possess up to 3 ounces of cannabis and 24 grams of concentrated cannabis (like vaporization oil or an edible).
  • Cannabis can be purchased only at state licensed dispensaries.
  • Cannabis cannot be consumed when operating a motor vehicle and it remains illegal to operate a vehicle in New York while under the influence of cannabis. Impaired driving can result in a charge of Driving While Ability Impaired By Drugs (DWAI) under Vehicle And Traffic Law Section 1192(4). This section states: “No person shall operate a motor vehicle while the person’s ability to operate such a motor vehicle is impaired by the use of a drug as defined in this chapter.” The world “drug” includes cannabis.
  • The smoking of cannabis is prohibited anywhere smoking tobacco is prohibited. In addition, landlords, property owners and rental companies can ban the use of cannabis on their premises.
  • Employers can enforce policies that prohibit cannabis impairment on the job.
  • Adults over 21 cannot cross state or international borders in possession of cannabis. It is also illegal to possess and use cannabis on federal lands or property.
  • Growing cannabis at home for personal use is not permitted under the new law until the Cannabis Control Board adopts regulations outlining the rules. It is expected that New Yorkers 21 years and older will be able to grow up to six plants in their home for personal use (3 mature plants and 3 immature plants) and a maximum of twelve plants per household (6 mature plants and 6 immature plants), even if there are three or more adults over the age of 21 in the residence. Home cultivated cannabis cannot be sold to anyone and is only intended for personal use.
  • Local municipalities may enact and enforce regulations relating to home cultivation of cannabis, however no municipality may completely ban or prohibit home cultivation.
  • The MRTA establishes three taxes on adult-use cannabis. There is a tax imposed at the distributor tier based on the milligrams (mg) of total THC in the cannabis product. There are different rates of tax depending on the cannabis product form.
  • On the retail sale to the consumer, there are two taxes: 9% state excise tax and 4% local excise tax.
  • All cannabis taxes will be deposited in the New York state cannabis revenue fund to administer the program and implement the law. The remaining funding would be split three ways: 40% to Education; 40% to Community Grants Reinvestment Fund; and 20% to Drug Treatment and Public Education Fund.
  • The MRTA will automatically expunge records for people with previous convictions for activities that are no longer criminalized. Individuals who qualify for expungement are not required to take any further action to have their records expunged.

MEDICAL MARIJUANA PROGRAM

  • New York’s medical cannabis law – Compassionate Care Act – was signed into law on July 5, 2014.
  • Medical marijuana is available for patients that have been diagnosed with one or more of the following severe debilitating or life threatening conditions: cancer, HIV infection or AIDS, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, multiple sclerosis, spinal cord injury with spasticity, epilepsy, inflammatory bowel disease, neuropathy, Huntington’s disease, post-traumatic stress disorder, chronic pain (as defined by 10 NYCRR §1004.2(a)(8)(xi)), pain that degrades health and functional capability as an alternative to opioid use or substance use disorder.
  • The severe debilitating or life-threatening condition must also be accompanied by one or more of the following associated or complicating conditions: cachexia or wasting syndrome, severe or chronic pain, severe nausea, seizures, or severe or persistent muscle spasms, PTSD or opioid use disorder.
  • To obtain medical marijuana, patients must first be certified by a registered practitioner (which includes physicians, physician assistants, and nurse practitioners). A list of registered practitioners can be found at the New York State Department of Health (DOH) Public List of Consenting Medical Marijuana Program Practitioners.
  • Once certified, patients must register with the DOH. Patients may designate up to two caregivers during the registration process. After the patient’s registration is processed, the designated caregiver(s) must then also register with the DOH.
  • Pursuant to the Compassionate Care Act there is a $50 registration fee; the Department is currently waiving the $50 fee for all patients and their designated caregivers.
  • Once a patient or caregiver’s registration is approved, the DOH will issue a registry identification card which patients must bring to a registered organization’s dispensing facility in order to purchase approved medical marijuana products. A list of Registered Organization Locations can be found here.
  • Registered organizations must make available at least one brand that has an equal ratio of THC to CBD, and one brand with a low-THC-high-CBD ratio). Each Registered Organization will also offer other products that have varying ratios of THC to CBD.
  • Prices for medical marijuana products vary widely amongst the registered organizations. The Compassionate Care Act does not mandate a discounted Medical Marijuana pricing program, but allows Registered Organizations to provide discounted products. Some Registered Organizations may offer reduced prices for qualifying certified patients.
  • Like recreational marijuana, medical marijuana products may not be transported outside of New York State.
  • New York State does not accept certifications or registry ID cards from other states.
  • Patients may possess a 30-day supply of medical marijuana. They may refill their 30-day supply seven days before it runs out.
  • The excise tax on medical cannabis is a 7% tax on the gross receipts from medical cannabis sold or furnished by a registered organization to a certified patient or designated caregiver.
  • The tax is imposed on the registered organization, which must pay it to the Tax Department. The tax may not be added as a separate charge or line item on a sales slip, invoice, receipt or other statement or memorandum of the price given to the retail customer.

HELPFUL RESOURCES

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.

Time Element Coverage

The Northwell policies provided “Time Element” coverage for lost earnings from the necessary “suspension” of business activities, if caused by “direct physical loss of or damage to Covered Property … caused by Covered Cause of Loss.”  The Court held there was no coverage under this provision because it required the cost or loss to be caused by direct physical loss or damage.  While Northwell alleged that the respiratory droplets carrying the coronavirus attached to surfaces, the Court concluded that the complaint failed to allege that the coronavirus compromised the physical integrity of objects by harming surfaces and structures, as opposed to harming the people who touched them.  The Court held that (1) the Northwell interpretation would collapse coverage for direct physical loss or damage into “loss of use” coverage; (2) the coronavirus did not “persist” on property, as the property could be usable when sanitized; and (3) the Northwell properties were not unusable, as they did continue to operate with extra precautions.

Interruption by Communicable Diseases Coverage

The Court found that Northwell had satisfied the first two conditions for Interruption by Communicable Diseases coverage, that Northwell ceased or slowed operations because of a governmental authority regulating the spread of a communicable disease.  The Court held that there was no coverage, however, because Northwell failed to allege that the government orders declared portions of its locations “uninhabitable,” as patients continued to “inhabit” hospitals and hospitals were not required to close buildings, although elective procedures were suspended.  “While the Orders certainly restrict access to hospitals, they fall short of ‘prohibiting’ access.”

Civil or Military Authority, Decontamination Costs, and Ingress/Egress Coverage

Judge Rakoff also rejected Northwell’s claims for coverage under the Civil or Military Authority, Decontamination Costs and Ingress/Egress policy provisions.  First, all three required the costs and losses to be caused by “physical loss and damage,” and he had already rejected Northwell’s argument for coverage under this definition.  He also found the claims under these provisions deficient for additional reasons.

Civil or Military Authority coverage requires an order prohibiting access in response to physical loss or damage to nearby property not belonging to the insured.  The Court held that the complaint did not allege nearby properties that caused a prohibition on access to Northwell facilities, and the facts did not support the allegation that any order prohibited access to Northwell facilities.

Decontamination Costs coverage applies to government-mandated costs to remove a virus or infected property, if the presence of an illness-causing agent was caused by physical loss or damage.  The Court held that the presence of COVID-19 was not caused by physical loss or damage, but by infected patients or visitors who released droplets containing the virus into the air.

In addition, the Court held that the Ingress/Egress coverage provision did not apply because it requires “physical obstruction,” and the government orders at issue were legal obstructions rather than physical barriers.

Exclusions to Coverage

Finally, the Court held that, even assuming there were coverage under the provisions above, an exclusion to coverage applied. The policy excluded coverage for a “release, discharge, escape or dispersal” of “contaminants or pollutants,” and defined “contamination” to include disease-causing viruses.  The Court found that there was a discharge or dispersal: “What is a sneeze or cough if not a discharge or dispersal?”  The Court also rejected Northwell’s argument that “discharge” or “dispersal” should be limited to environmental or industrial pollutants and contaminants because the policies specifically defined “contaminants to include viruses.”

Conclusion

Judge Rakoff’s decision addressed many issues concerning insurance coverage for the COVID-19 pandemic, and rejected Northwell’s arguments across the board.  The decision is likely to be appealed by Northwell, so ultimately the Second Circuit may rule on these important coverage issues.

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).

The legislature may appropriate OSF monies for the purposes spelled out in the amended Mental Hygiene Law, which include programs to:

  • Prevent substance abuse disorders through youth-focused and school-focused public health education.
  • Develop public health campaigns to reduce the stigma against individuals with a substance use disorder, and provide information about the risks of substance abuse and how to locate services to treat it.
  • Provide substance use disorder treatment, emphasizing programs that include a continuum of care from screening and assessment, active treatment (such as medication-assisted, psychiatric medication, psychotherapy and family therapy), case management and relapse management for use disorders and co-occurring disorders, and related services such as vocational, literacy and family counseling.
  • Provide harm reduction counseling to reduce adverse health consequences such as overdoses and communicable diseases.
  • Provide housing services for people recovering from substance abuse.
  • Support community-based programs that reduce the likelihood of criminal justice involvement for individuals with substance abuse disorders.
  • Provide programs for pregnant women and new parents who have, or had, a substance abuse disorder, and newborns with neonatal abstinence syndrome.
  • Provide for educational and vocational training for those with or at risk of a substance abuse disorder.

Mental Hygiene Law, §25.18.

The statute creates an opioid settlement board under OASAS to make recommendations on how to allocate OSF funding, and recommendations to the legislature about adding or removing categories of expenditures eligible for funding.  Mental Hygiene Law, §25.18(c). The settlement board will have 19 members, including two appointed by the governor, four by the speaker of the Assembly and president of the Senate, two by the NYS Attorney General, one by the mayor of New York City and seven representing counties throughout NYS, plus the commissioners of OASAS, the Department of Health and the Office of Mental Health as ex officio, non-voting members.  The voting members will serve three-year terms without compensation but with payment of actual and necessary expenses.  Mental Hygiene Law, §25.18(c)(3).  The statute contains conflict of interest prohibitions for members. §25.18(c)(7).  The advisory board will meet quarterly, and make its recommendations for the appropriation of OSF funds on or before November 1 each year, starting this year, to the governor and the legislature, in a written report. §25.18(c)(9).  Beginning one year after the first deposit of amounts into OSF, the relevant agency commissioners, in consultation with the advisory board, are required to provide an annual report on OSF funding detailing, among other things, which entities received funding, the criteria used to make the awards, how the funds were used, and how effectively they were used. Id. 

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.

This legislation also extends investigatory powers to DOH, as well as the ability to issue civil penalties, taking mitigating factors into account, for failure of hospitals to comply with or timely correct violations of the staffing plans.  DOH is also required to submit an annual report by the end of the year, which shall include the number of complaints submitted to DOH, the number of investigations, and the costs for such investigations, if any.  Prior to the submission of the annual report by DOH, it shall be reviewed by a stakeholder workgroup consisting of hospital associations, nursing unions and other ancillary members of frontline workers.

This legislation also requires the creation of an independent advisory commission composed of nine (9) experts in staffing standards and quality of patient care:  three (3) in nursing, three (3) representing nursing unions, and three (3) representing general hospitals, with each group consisting of appointments by the Governor, Speaker of the Assembly and/or the Temporary President of the Senate.  The advisory commission shall meet from time to time to evaluate the effectiveness of the staffing committees, as well as to review the annual report submitted by DOH.  The advisory commission shall submit a report with its recommendations to improve working conditions and quality of care in hospitals.

While this legislation attempts to address claims that hospitals have been understaffed for some time, it does not address the fundamental issue of the acute nurse labor shortage, which has been exacerbated by COVID-19.  There are limited exceptions for “unforeseeable emergency circumstances” (such as officially declared national, state, or municipal emergencies; the activation of disaster plans; or any unforeseen disaster or other catastrophic event that immediately affects or increases the need for health care services), and “special considerations” to avoid unreasonable burdens on critical access hospitals and sole community hospitals, however, the legislation specifically prohibits the defense by hospitals of the inability to secure sufficient staff if the lack of staffing was “foreseeable” and could be “prudently planned for” or involved “routine nurse staffing needs,” such as typical staffing patterns, absenteeism, or time-off requests.

As with other recently enacted healthcare reforms, the long term effects of this legislation, and the ability of hospitals to comply with the staffing plans, remain to be seen.

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, but also on whether or not regulators attempted to hide that information and its potential linkage to the readmission order.

But regulators have not been the only target of this retroactive scrutiny.  Nursing home operators themselves have faced suspicion in regard to such readmissions.  In particular, policymakers have questioned whether they readmitted COVID-positive residents when they knew they could not safely care for them, and whether they provided sufficient staff and equipment to do so even when they could.  The merits of these accusations are arguable – and even if true, are not necessarily true for every provider who accepted a COVID-positive resident.  Notwithstanding, they have resulted in new legislation that fundamentally changes the landscape for nursing home operators.

The 2021-22 New York State Budget includes a change to permanent law limiting nursing home profit margins.  Specifically, effective January 1, 2022, a minimum of 70% of nursing home revenue must be spent on direct resident care, including 40% for resident-facing staffing.  Fifteen percent of costs associated with resident-facing staffing by a registered nurse, licensed practical nurse, or certified nurse aide that is contracted out by a facility shall be deducted from the calculation of the amount spent on resident-facing staffing and direct resident care.  Any nursing home that, on an annual basis, fails to comply with these rules, or whose total operating revenue exceeds expenses by more than 5%, must remit the difference between required spending and actual spending or such excess revenue to the State by November 1 the following year.  Such funds will be used to support the Nursing Home Quality Pool.

Some nursing homes are exempt from these requirements, including continuing care retirement communities and nursing homes primarily serving medically fragile children, people with HIV/AIDS, people requiring behavioral intervention, people requiring neurodegenerative services, and other specialized populations identified by the Commissioner of Health.  The Commissioner is also empowered on a case-by-case basis to waive all these requirements with respect to a nursing home that experienced “unexpected or exceptional circumstances that prevented compliance,” or exclude from revenues and expenses extraordinary revenues and capital expenses incurred due to a natural disaster or other circumstances identified by the Commissioner.  Notice of such waiver must be given to the Long-Term Care Ombudsman and the Chairs of the Senate and Assembly Health Committees and posted on the Department of Health website at least 30 days prior.  The Commissioner of Health is required to issue regulations, seek amendments to the Medicaid State Plan, seek any necessary Medicaid waivers, update applicable forms, and take any other actions necessary to implement these changes.

And this is only the first step.  As of the date of this writing, additional legislation in this area is making its way through the Legislature.  The bill – which is the latest version of legislation that has been debated in Albany for several years – would require the Commissioner of Health to establish minimum staffing levels for nursing homes.  Nursing homes that are out of compliance would be subject to a range of civil penalties reflecting a variety of mitigating factors, including extraordinary circumstances, the frequency and nature of non-compliance, and the existence of an acute labor supply shortage.  At the same time, the Senate Aging Committee chair has announced she is planning a hearing on long term care workforce issues in the near future.  And other legislative activity targeting nursing homes can be expected.

In the months ahead, policymakers will continue to review the State’s response to COVID-19 and enact reforms that are intended to address problems revealed by the pandemic.  These reforms will likely extend far beyond just nursing homes, and have the potential to fundamentally change healthcare delivery in New York State, for better or worse.  The long-term effects of these measures, whether positive or negative, remain to be seen.

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, strictly regulated what services could be delivered via telehealth, which providers and patients could utilize telehealth, and which telehealth modalities were permissible.  While the laws governing telehealth were becoming gradually more permissive, progress was slow.  In contrast, one of the first Executive Orders issued by the Governor in response to the pandemic waived key legislation “to the extent necessary to allow additional telehealth provider categories and modalities, to permit other types of practitioners to deliver services within their scope of practice and to authorize the use of certain technologies for the delivery of health care services to established patients, pursuant to such limitations as the commissioner of [the relevant] agencies may determine appropriate . . . ”  Executive Order 202.1.  At the same time, the Legislature passed and the Governor signed legislation that expanded the list of professionals permitted to utilize telehealth and the list of permissible telehealth modalities, and that provided some additional protections to patients receiving telehealth services.

The general consensus (with some exceptions) seems to be that the expansion of telehealth services was generally effective.  Patients were enabled to access vital services while minimizing risk of COVID exposure, and some of the concerns about remote healthcare delivery (e.g., diminished quality of care, increased opportunity to violate scope of practice or informed consent laws, etc.) seem not to have been a major concern.  Accordingly, the Legislature recently further expanded the permissible uses of telehealth, removing telehealth-specific limitations on the originating and destination sites in telehealth delivery, and further expanding the list of services that can be delivered via telehealth.  In short, New York State policymakers have essentially doubled down on the promise of telehealth.

However, some barriers and concerns remains, particularly including financial barriers.  Inherent here is the recognition that theoretical access to telehealth is meaningless if a patient or provider cannot afford the necessary technology.  Similarly, telehealth will continue to be underused if it is not reimbursed in a manner that makes its use attractive to providers in comparison to in-person interactions.  In order to begin addressing these issues and others, in May 2020, Governor Cuomo appointed members to the Reimagine New York Commission, which is tasked to “focus initially on recommendations to increase opportunity in three essential ways: reducing the digital divide, improving access to healthcare, and creating more and better employment in an increasingly digital economy.”  Included in their work product has been a series of recommendations to further codify and modernize telehealth in New York State.  Based on these recommendations, Governor Cuomo announced the following comprehensive telehealth reform policies, some of which have since been accomplished in whole or in part:

  • Adjust reimbursement incentives to encourage telehealth
  • Eliminate outdated regulatory prohibitions on delivery of telehealth
  • Remove outdated location requirements
  • Address technical unease among both patients and providers through training programs
  • Establish other programs to incentivize innovative uses of telehealth

In addition, to further support telehealth initiatives Governor Cuomo announced a guarantee of affordable internet for low-income families. That legislation requires internet providers to offer $15 per month high speed internet plan for low-income households.

The Legislature is also working to address outstanding issues.  Pending legislation addresses the amount of reimbursement available for telehealth (both by Medicaid and commercial insurers) and permissible modalities (including asynchronous telemedicine).  As more and more providers and entrepreneurs identify more opportunities for the use of telehealth, we can anticipate additional legislative and regulatory measures to authorize such uses.

The full impact of these changes is not yet known.  For instance, if the digital divide between rich and poor persists, it is entirely conceivable that increasing use of telehealth will exacerbate existing disparities in access to care. Similarly, the impact of the use of telehealth on professional malpractice and misconduct will need to be monitored on an ongoing basis.  But in general, COVID has essentially forced policymakers to act on issues that had remained unaddressed for far too long, and has gone a long way toward helping New York State’s regulatory regime catch up to existing technology in the telehealth space.

No matter where you look lately it seems like you can find a store selling CBD-based items or find an article discussing the medical benefits of CBD. In fact a simple Google search of the term “CBD” pulls up an overwhelming 225 million results. This article will cover the basics of CBD so that you can get all of the facts without having to parse through pages and pages of information.

Let’s start right at the beginning. What is CBD? CBD is the abbreviation for cannabidiol. CBD is a nonpsychoactive chemical compound derived from the hemp plant and is the second most prevalent of the active ingredients of marijuana.

CBD is increasing in popularity due to ongoing studies which show that CBD may provide benefits for persons suffering from pain, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, anxiety, depression, infection, cancer and a multitude of other ailments. The U.S. Food and Drug Administration (FDA), which regulates marijuana products under the Food, Drug, and Cosmetic Act (“FD&C Act”) and Section 351 of the Public Health Service Act, has raised concerns over the usage of CBD products, however, as “there has been no FDA evaluation regarding whether they are safe and effective to treat a particular disease, what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.” More than 70% of CBD extracts sold online, for instance, were mislabeled regarding potency, according to a Penn Medicine study in 2017.

While CBD is readily obtainable in most parts of the United States, whether CBD is legal is not a simple yes or no answer.

In December 2018, Congress passed the Farm Bill which legalized hemp – defined in the Farm Bill as cannabis and cannabis derivatives with very low concentrations – less than 0.3 percent – of THC. THC is the chemical compound in cannabis responsible for making a person feel “high.” The Farm Bill allows hemp cultivation broadly, and explicitly allows the transfer of hemp-derived products across state lines for commercial or other purposes.

Many people assume that, because CBD is derived from the hemp plant, CBD is likewise automatically legal at the federal level under the Farm Bill. That assumption is inaccurate, however, and that discrepancy is causing much confusion and uncertainty with respect to the production, distribution and use of CBD products.

While the Farm Bill removes hemp-derived products from its Schedule I status under the Controlled Substances Act, the legislation does not legalize CBD generally. As a result, certain uses of CBD, including the addition of CBD in foods and drinks, remain illegal under federal law.

The FDA is struggling to determine how to regulate CBD. The FDA held a hearing at the end of May 2019 “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” The FDA is also gathering data from the public through the use of a docket that is open for comment until July 16, 2019.

More recently the FDA put out a consumer update entitled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.” In the article the FDA states that it “recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD.”

Because the federal government’s regulation of CBD is lagging, many states have laws legalizing CBD with varying degrees of restriction.

New York has maintained that CBD is legal, however adding CBD to food or drinks has recently been banned in New York City. “As of July 1, 2019, the Health Department is embargoing food and drink products that contain CBD — the products will have to be returned to the supplier or discarded,” the city’s health department said. “Starting October 1, 2019, the Health Department will begin issuing violations to food service establishments and retailers for offering food or drink containing CBD. Violations may be subject to fines, and for food service establishments, violation points may count toward the establishment’s letter grade.”

The legal status of CBD is constantly changing and there will likely be further changes over the next few months as the FDA continues to develop and update its regulations concerning the use of CBD. We will continue to provide updates as new information comes to light.

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 intent.

The Court of Appeals began its decision with a clear and broad statement that the practice of medicine by corporations controlled by non-physicians is prohibited:

“Only licensed physicians may practice medicine in New York.  The unlicensed are not bound by the ethical rules that govern the quality of care delivered by a physician to a patient.  By statute, regulation, and the common law, the corporate form cannot be used as a device to allow nonphysicians to control the practice of medicine.”

A jury in the lower court found that the plaintiff, Andrew Carothers, M.D., P.C. (“Carothers PC”), which provided MRI services, was controlled and operated by Hillel Sher, a non-physician.  Sher owned and controlled companies that held long-term leases for three MRI centers and equipment.  The evidence at trial showed that Sher’s companies:

  • Leased the MRI equipment, which was 10 to 11 years old, to Carothers PC for $547,000 per month, an “exorbitant” amount. One piece of equipment subleased to Carothers PC for $75,000 per month was leased by Sher’s companies for $5,950.  Carothers PC could have purchased another piece of MRI equipment that it subleased for two months’ subrent.  It could have purchased used MRI equipment to replace all of the subleased equipment for less than $600,000.
  • Carothers PC paid $60,000 per year to rent 9 fax machines, although it  could have purchased “scores of new [fax] machines every year for that price.”
  • The leases for the MRI centers gave Sher the right to terminate them for any reason, even if rent was paid and current, on 30 days’ notice. Carothers PC had no right to terminate the leases without cause.
  • The bank account that Carothers PC opened was controlled by an associate of Sher, who Carothers PC hired as its executive secretary. The executive secretary wrote the checks.  Carothers never issued a check from the account.
  • Carothers provided practically no oversight or supervision of the physicians, and did not evaluate or discipline them. He reviewed, at most, 0.2% of the MRI scans performed for Carothers PC’s patients.
  • The salary of Caruther PC’s executive secretary was higher than Dr. Carothers’ salary.
  • Large sums were transferred from the bank account of Carothers PC to the executive secretary’s personal account to pay her personal expenses and Sher’s.  Larger sums were transferred to Sher.  More than $12 million was funneled through Carothers PC to Sher and the executive secretary.

The New York Court of Appeals found that the facts presented in the Carothers PC case were very similar to those in State Farm Mut. Auto. Ins. Co. v Mallela, 372 F3d 500, 503 (2d Cir. 2004):  Non-physicians paid physicians to use their names to established medical service corporations, the non-physicians operated them and billed the physicians nominally in charge at inflated rates so that the profits from the medical practice were channeled to the non-physicians.  In Mallela, the Second Circuit asked the New York Court of Appeals to answer a certified question:  whether a medical service corporation “fraudulently incorporated” under New York law by non-physicians and operated by the non-physicians was entitled to reimbursement for medical services provided by its physicians.  The New York Court of Appeals answered the question no, ruling that a medical provider not solely owned and controlled by physicians was not entitled to insurance reimbursement.

The New York Court of Appeals, in the Carothers case, clarified that the “fraudulently incorporated” language of the Mallela decision, which was part of the Second Circuit’s certified question, did not mean that common-law fraudulent conduct of the medical services corporation’s business or common-law fraudulent intent was required for an insurance company to deny payment.  In Carothers, the finding by the jury “that [Carothers PC] was in material breach of the foundational rule for professional corporation licensure – namely that it be controlled by licensed professionals – was enough to render [Carothers PC] ineligible for reimbursement. . . .”  The insurer could deny payment if the medical services corporation was improperly established and operated by non-physicians, or was properly established but subsequently operated and controlled by non-physicians.  Although Carothers PC attempted to avoid this result by arguing that the improper control by Sher was merely an instance of improper fee splitting of a professional corporation’s profits with a non-physician and should not result in the denial of reimbursement, the jury determined that Carothers POC was controlled by non-physicians and did not merely split fees with it.

Last week, in Washington v. Barr, the Second Circuit addressed a case seeking to strike down the federal government’s classification of marijuana as a Schedule I drug under the Controlled Substances Act (CSA). The Court held that plaintiffs had failed to exhaust their administrative remedies before the Drug Enforcement Administration (DEA). Rather than dismissing the case, however, the Court took the unusual step of holding the case in abeyance and retaining jurisdiction to take “whatever action might become appropriate if the DEA does not act with adequate dispatch.”

The Court majority determined that the case was unusual because the plaintiffs were individuals plausibly alleging a life-or-death threat to their health. Plaintiffs included a businessman seeking to expand his medical marijuana business into whole-plant cannabis products; two children with dreadful medical problems asserting that they had exhausted traditional medical options and marijuana had saved their lives; an Iraq War veteran who had managed his PTSD through medical marijuana; and the Cannabis Cultural Association, an organization focused on the way marijuana convictions have disproportionately affected people of color and prevented minorities from participating in the new state-legal marijuana industry.

Plaintiffs did not first bring their challenge to the Schedule I classification of marijuana to the DEA, the agency that has the authority to reschedule marijuana. Although the CSA does not mandate exhaustion of administrative remedies, the Second Circuit agreed that exhaustion is appropriate and consistent with Congressional intent. Congress intended to implement scheduling decisions under the CSA through an administrative process, and requiring exhaustion is consistent with that intent. The Court determined that the question raised by plaintiffs’ suit—whether developments in medical research and government practice should lead to a reclassification of marijuana—is precisely the sort of question that calls for the application of an agency’s special knowledge. Also, the Court held that none of the recognized exceptions to exhaustion, such as futility, inability to grant adequate relief, or undue prejudice, applied.

The Second Circuit gave credence, however, to plaintiffs’ argument that the administrative process might delay their ordeal intolerably.

But in light of the allegedly precarious situation of several of the Plaintiffs, which at this stage of the proceedings we must accept as true, and their argument that the administrative process may not move quickly enough to afford them adequate relief, we retain jurisdiction of the case in this panel, for the sole purpose of taking whatever action might become appropriate should the DEA not act with adequate dispatch.

Thus, if the plaintiffs seek agency review, and “the agency fails to act with alacrity,” plaintiffs can return to the Court under its retained jurisdiction.

Judge Dennis Jacobs agreed that plaintiffs had failed to exhaust administrative remedies, but dissented from the majority’s decision to hold the case in abeyance in case the DEA failed to act with “adequate dispatch.” He viewed DEA as unlikely to discern the majority’s view of “adequate dispatch” or “alacrity,” and did not anticipate a swift ruling given the need for an assessment of countervailing risks, the pendency of legislation, and the eliciting of opinions on issues of medicine and public health. Judge Jacobs also dismissed the cases the majority had cited in supporting its abeyance determination: “None of these cases supports the idea that a court is permitted to hold a case in abeyance because the court may on contingency gain jurisdiction to hear it, and can bully the agency in the meantime.”

As the New York legislature and other states address the issue of legalization of marijuana, the DEA’s assessment of the scheduling issue-and the speed with which DEA makes or does not make that decision-may come before the Second Circuit again.