The New York State Department of Labor (the “DOL”) issued an emergency regulation clarifying its minimum-wage rules regarding home care employees. The emergency regulation provides that sleep and meal times for home care aides who work shifts of 24 hours or more are not counted as hours worked. Recently, there has been a ringing dissonance between the DOL and decisions set forth by the New York State Appellate Divisions, First and Second Departments, regarding whether home care workers should be paid for an entire 24-hour shift, including sleep and meal time. In fact, the DOL expressly cited the fact that the emergency regulation is being promulgated in direct reaction to decisions issued by the New York State Appellate Divisions. For reference, the decisions triggering the emergency regulation are: Moreno v. Future Care Health Servs., Inc., 2017 N.Y. App. Div. LEXIS 6462 (2d Dept Sept. 13, 2017); (2d Dep’t Sept. 13, 2017); Andreyeyeva v. New York Health Care, Inc., 2017 N.Y. App. Div. LEXIS 6408 (2d Dep’t Sept. 13, 2017); and Tokhtaman v. Human Care, LLC, 149 A.D.3d 476 (1st Dep’t Apr. 11, 2017).

The above-referenced decisions effectively flipped the New York home care industry on its head, each holding, in sum, that home care workers were entitled to pay for all 24 hours worked, including sleep and meal time. Enter the DOL, on October 5, 2017, who quickly put any remaining ambiguity to rest once and for all stating “that hours worked may exclude meal periods and sleep times for home care aides who work shifts of 24 hours or more”. The DOL reasoned that “[t]his regulation is needed to preserve the status quo, prevent the collapse of the homecare industry, and avoid institutionalizing patients who could be cared for at home, in the face of recent decisions by the State Appellate divisions that treat meal periods and sleep time [as hours worked]”.

The emergency regulation is expected to return the home care industry back to normalcy and prevent home care agencies from ceasing to provide “vital, lifesaving care” to thousands of New Yorkers who depend on it. The DOL explained that this “emergency adoption amends the relevant regulations to codify the Commissioner’s longstanding and consistent interpretations that such meal periods and sleep times do not constitute hours worked for purposes of minimum wage and overtime requirements”. And so, the longstanding rule about sleeping on the job still stands: you won’t get paid for it in New York.

Note:  Special thanks to our law clerk, Nicholas G. Moneta, for his assistance in drafting this blog post.

In our previous post, Medical Marijuana 103: Patient and Practitioner Regulations in New York State, we discussed that patients certified for medical marijuana use can designate up to two caregivers. Caregivers can assist patients who are unable to pick up medical marijuana at a dispensing facility or are unable to administer medical marijuana to themselves properly.

Previously the Medical Marijuana Program only allowed for designated caregivers to be natural persons. On October 5, 2017, however, the New York State Department of Health (“DOH”) issued emergency regulations that expand the definition of caregiver to allow certain facilities to be designated caregivers. By expanding the definition in this way, patients who are located in or reside at certain facilities can designate their facility as their caregiver, thus making it easier for such patients to obtain medical marijuana.

The new regulations define a designated caregiver as either a natural person or a facility. The term “facility” is further defined as, among others, hospitals, adult day care facilities, community mental health residences, and private and public schools. In addition, each division, department, component, floor or other unit of a parent facility may be designated as a “facility” for purposes of being designated a caregiver.

Just like natural persons, facilities will need to register with the DOH in order to be designated a caregiver for purposes of the Medical Marijuana Program. Once registered with the DOH facilities will be authorized to lawfully possess, acquire, deliver, transfer, transport and/or administer medical marijuana to certified patients residing in, or attending, that facility.

The DOH considered alternatives prior to issuing the emergency regulations, stating:

The Department could have chosen to keep the status quo and not allow patients to designate facilities as designated caregivers. The Department could have also allowed certified patients to designate an individual within the facility to be a caregiver. However, these options are not viable since patients in facilities may be cared for by multiple staff members in the course of a day. Certified patients have severe debilitating or life-threatening conditions and the regulatory amendments would help to prevent adverse events associated with abrupt discontinuation of a treatment alternative that may be providing relief for certified patients in these facilities.”

The regulations were published in the New York State Register on October 25, 2017. The DOH will accept comments from the public for a minimum of 45 days following the date of publication. After publication in the Register and receipt of public comment, the agency may either adopt, revise or withdraw the proposal. This change is just one of the latest revisions implemented by the DOH in an attempt to strengthen and expand New York’s struggling Medical Marijuana Program.

Few, if any, in the medical industry are unfamiliar with the federal Anti-Kickback Statute (“AKS”).  Under AKS, those giving or receiving compensation for referrals for items or services reimbursed by the federal healthcare programs are subject to criminal prosecution.  The statute is intended to prevent exploitation of the federal healthcare system, avoid unnecessary inflation of program costs and encourage fair competition in the industry.

AKS prohibits, among other things, the knowing and willful payment or receipt of any form of compensation to induce or reward referrals involving any item or service payable by federal healthcare programs.  “Federal healthcare programs” include more than just Medicare and Medicaid – “any plan or program providing health care benefits, whether directly through insurance or otherwise, that is funded directly, in whole or part, by the United States government (other than the Federal Employees Health Benefits Program), or any state health care program” is included.  This means that remuneration for referrals in connection with items and services that are reimbursable under TRICARE, the Veterans Administration, Federal Employees’ Compensation Act, and block grant programs are all subject to prosecution under AKS.

 

Where items or services are not reimbursable by a federal healthcare program, providers and referring parties are not subject to AKS prosecution.  However, due to an emerging trend in prosecution, the absence of reimbursement from federal healthcare programs should no longer leave providers and referral sources with a sense of security that they cannot be prosecuted for kickback arrangements.

 

Prosecutors are increasingly bringing charges against payers and recipients of remuneration for referrals in the medical arena under the Travel Act.  The Travel Act criminalizes the use of the United States mail and interstate or foreign travel for the purpose of engaging in certain specified criminal acts.  The Travel Act typically enforces two categories of state laws – laws prohibiting commercial bribery (i.e. corrupt dealings to secure an advantage over business competitors) and laws addressing illegal remuneration, including specific provisions regarding improper payments in connection with referral for services.

 

In two very recent high profile cases, prosecutors brought charges against those allegedly involved in kickback schemes under the both AKS and the Travel Act – Biodiagnostic Laboratory Services in New Jersey and Forest Park Medical Center in Texas.  Both cases have resulted in several plea bargains, yet both have charges under AKS and the Travel Act that are still pending.  While no court has directly ruled on the merits of prosecuting kickback schemes for medical services and items under the Travel Act, it is noteworthy that, in the Forest Park Medical Center case, the charges under the Travel Act survived a motion to dismiss at the district court level just last month.

 

All parties involved in referral arrangements for medical items or services should be on heightened alert as a result of this development.  Whereas AKS can only be used to prosecute parties to a kickback arrangement where federal healthcare program funds are at issue, the use of the Travel Act may broaden prosecutors’ reach to the private payor sector, even where federal healthcare programs are not involved.

This blog post is the fifth in a series of articles discussing the current state of the law in New York regarding medical marijuana. To read the latest post in the series, Medical Marijuana 104: Responsibilities of Health Insurers, click here.

As you may recall from our first post in this series, medical marijuana in New York was legalized through the passage of the New York Compassionate Care Act (“CCA”) in 2014. The CCA also created new anti-discrimination protections for medical marijuana users. Namely, the CCA provides that patients who are certified for medical marijuana use shall not be subject to “disciplinary action by a business” for exercising their rights to use medical marijuana. The CCA further provides that being a certified patient is the equivalent of having a disability for purposes of the New York State Human Rights Law (“NYSHRL”).

Together the CCA and NYSHRL provide that New York employers with four or more employees are prohibited from terminating or refusing to employ an individual on the basis of his/her status as a certified medical marijuana patient. In addition, employers must provide reasonable accommodations to certified patients as a result of his or her disability. Accordingly, an employer may be subject to a discrimination claim if it fires or disciplines an employee for lawfully consuming marijuana under the CCA.

The CCA does contain two exceptions to the above general rules. First, the CCA does “not bar the enforcement of [an employer’s] policy prohibiting an employee from performing his or her employment duties while impaired by a controlled substance.” Second, the Act does “not require any person or entity to do any act that would put the person or entity in violation of federal law or cause it to lose a federal contract or funding.”

The Americans with Disabilities Act (“ADA”), which became law in 1990, is a civil rights law that prohibits discrimination against individuals with disabilities in all areas of public life, including jobs, schools, transportation, and all public and private places that are open to the general public. The purpose of the law is to make sure that people with disabilities have the same rights and opportunities as everyone else.

Marijuana in any form and for any use is illegal at the federal level under the Controlled Substances Act (“CSA”). The ADA provides that a person’s illegal use of drugs is grounds for denying employment or firing from employment. The ADA defines “illegal use of drugs” as follows: “the use of drugs, the possession or distribution of which is unlawful under the Controlled Substances Act. Such term does not include the use of a drug taken under supervision by a licensed health care professional, or other uses authorized by the Controlled Substances Act or other provisions of Federal law.”

For the most parts court have, to date, agreed that, because the CSA does not allow medicinal use of marijuana, a medical professional cannot legally, as a matter of federal law, supervise medical marijuana use so as to bring an employee under the ADA’s protection. See, e.g., James v. City of Costa Mesa, 2010 U.S. Dist. LEXIS 53009, at *8-11 (C.D. Cal. Apr. 30, 2010); Barber v. Gonzales, 2005 U.S. Dist. LEXIS 37411, at *2-5 (E.D. Wash. July 1, 2005); Johnson v. Columbia Falls Aluminum Co., 2009 WL 865308, at *4 (Mont. Mar. 31, 2009).

Case law in this area is developing and uncertainty remains as state laws clash with federal requirements.

In 2015, for example, the Colorado Supreme Court unanimously held that employers may still terminate employees who use medical marijuana – even though medical marijuana use is specifically authorized by the Colorado Constitution and Colorado law protects employees’ lawful off-duty conduct.  The Court held that marijuana use (whether for medicinal or recreational use) remains unlawful under federal law and therefore medical marijuana use cannot be deemed “lawful” under the state’s off-duty conduct law.

On the other hand, the Massachusetts Supreme Judicial Court provided that the plaintiff, a patient who qualified for the medical use of marijuana and had been terminated from her employment because she tested positive for marijuana, could seek a civil remedy against her employer through claims of handicap discrimination in violation of Massachusetts laws.

Similarly, the Superior Court of Rhode Island in 2017 held that an employer’s enforcement of its neutral drug testing policy to deny employment to an applicant because she held a medical marijuana card violated the anti-discrimination provisions of the state medical marijuana law.

In New York, the Taxi & Limousine Commission (“TLC”) filed a petition seeking the revocation of the respondent taxi driver’s TLC Driver License because the driver tested positive for marijuana. New York City’s Office of Administrative Trials & Hearings (“OATH”) disagreed and recommended that the petition be dismissed, finding that revocation solely because of the driver’s status as a certified medical marijuana patient would violate New York City and State laws.  The TLC adopted the OATH decision.

In our next post we’re going to continue our review of important parties that play a role in the medical marijuana industry. To be sure not to miss the article when it comes out we invite you to subscribe to the Farrell Fritz New York Health Law Blog.

In our July 10, 2017 post, Concierge Medicine – Is it for you?, we cautioned that Medicare compliance concerns do not fall away when moving to a concierge or direct-pay model.  HHS has determined that concierge-style agreements are permitted as long as Medicare requirements are not violated.  Unless a physician has opted out of Medicare, the predominant requirement is that an access or membership fee cannot be charged to a Medicare patient for services that are already covered by Medicare.  But how does a concierge physician know where to draw the line?  The relevant authorities have issued very limited guidance in this area.

In March 2004, an OIG Alert was issued reminding Medicare participating providers that they may not charge Medicare patients fees for services already covered by Medicare.  OIG used, as an example, a case involving physician’s charge of $600 for a “Personal Health Care Medical Care Contract” that covered, among other things, coordination of care with other providers, a comprehensive assessment and plan for optimum health, and extra time spent on patient care.  Because some of these services were already reimbursable by Medicare, the physician was found to be in violation of his assignment agreement and was subjected to civil money penalties.  The physician entered into a settlement with OIG and was required to stop offering these contracts.

In 2007, OIG settled another case involving a physician engaged in a concierge-style practice.  There, the physician, who also had not opted out of Medicar, asked his patients to enter into a contract under which the patients paid an annual fee. Under the contract, the patient was to be provided with an annual comprehensive physical examination, coordination of referrals and expedited referrals, if medically necessary, and other service amenities.  The physician was similarly found to have violated the Civil Monetary Penalties Law by receiving additional payment for Medicare-covered services and agreed to pay $106,600 to resolve his liability.

As demonstrated by these settlements, violations of a physician’s assignment agreement results in substantial penalties and exclusion from Medicare and other Federal health care programs.  It would behoove a concierge physician to tailor contracts offered to Medicare patients.  Fees charged under such contracts should relate only to noncovered services and amenities.  For example, fees could relate to additional screenings by the concierge physician that are not covered by Medicare or amenities such as private waiting rooms.

According to the GAO’s 2005 Report on Concierge Care Characteristics and Considerations for Medicare, HHS OIG has not issued more detailed guidance on concierge care because its role is to carry out enforcement, not to make policy.  However, physicians with specific concerns regarding the structure of their concierge care agreements or practices may request an advisory opinion from HHS addressing their concerns.  Advisory opinions are legally binding on HHS and the party so long as the arrangement is consistent with the facts provided when seeking the opinion.

Next week, look for the release of Medical Marijuana 105, the fifth post in a series of posts discussing the current state of law in New York regarding medical marijuana.  To read the latest post in the series, Medical Marijuana 104:  Responsibilities of Health Insurers, click here.

This blog post is the third in a series of articles discussing the current state of the law in New York regarding medical marijuana. To read the latest post in the series, Medical Marijuana 102: NYS Registered Organizations and Dispensaries, click here.

In today’s post we’re going to be reviewing the requirements imposed by New York’s Medical Marijuana Program upon patients and certifying practitioners. As of August 22, 2017, 1,184 practitioners have registered with the NYS Department of Health (“DOH”) for the purpose of certifying patients for medical marijuana use and 28,077 patients have been certified for such use.

The DOH authorizes physicians, nurse practitioners and physician assistants to certify patients for medical marijuana use. As we mentioned in Medical Marijuana 101, New York’s Medical Marijuana Program is available only to patients who suffer from one of the following severe, debilitating or life-threatening conditions: cancer, positive status for HIV or AIDS, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, inflammatory bowel disease, neuropathy, chronic pain, or Huntington’s disease. Patients must also have one of the following associated or complicating conditions: cachexia or wasting syndrome, severe or chronic pain, severe nausea, seizures, or severe or persistent muscle spasms.

Practitioners who wish to certify patients to use medical marijuana must meet four general criteria. First, the practitioner must be qualified to treat patients who suffer from one or more of the serious conditions listed above.

Second, the practitioner must be either (1) a licensed physician who is in good standing as a physician and practicing medicine in New York State, (2) a certified nurse practitioner who is in good standing as a nurse practitioner and practicing in New York State, or (3) a licensed physician assistant who is in good standing as a physician assistant and practicing in New York State under the supervision of a physician registered with the New York State Medical Marijuana Program.

Third, the practitioner must have completed a four-hour course approved by the NYS Health Commissioner. The course must include the following course content: the pharmacology of marihuana; contraindications; side effects; adverse reactions; overdose prevention; drug interactions; dosing; routes of administration; risks and benefits; warnings and precautions; abuse and dependence; and such other components as determined by the commissioner. Currently the Commissioner has only approved two providers, TheAnswerPage and The Medical Cannabis Institute, to offer the course. The course is available to all interested parties, meaning that you can take the course even if you are not in the medical field and/or not looking to certify patients for medical marijuana use.

Lastly, the practitioner must have registered with the DOH. Practitioners can only register with the DOH if they’ve taken the four-hour course. Once a practitioner has completed the registration process they will then have access to the Medical Marijuana Data Management System which will allow them to issue certifications to qualifying patients.

Qualifying patients suffering from the severe illnesses listed above can learn more about whether medical marijuana may help them by speaking with a practitioner that is registered with the program. To help patients locate a registered practitioner, the DOH keeps an updated list of registered practitioners on its website.

Once patients are certified by a registered practitioner for medical marijuana use, patients must register with the DOH by, among other things, providing documentation to prove their identity and NYS residency. When patients register with the DOH they can also designate up to two caregivers. Those caregivers must also register with the DOH using the same online system as the one used by patients. Pursuant to the Compassionate Care Act there is a $50 application fee but the DOH is currently waiving the $50 fee for all patients and their designated caregivers.

Once a patient or caregiver’s registration is processed, the DOH mails a registry ID card directly to the patient or caregiver. Registrations expire when the certification that was issued by the practitioner expires. At this time, New York State does not accept certifications or registry ID cards from other states. This is not unusual as there are currently only three states (Nevada, Hawaii and Maine) that practice full reciprocity and will legally allow, under certain circumstances, out-of-state patients to make purchases at licensed dispensaries.

Now that we’ve learned about the basic regulations covering patients and practitioners we’re going to turn our attention to other important parties that play a role in the medical marijuana industry. Check back soon for Medical Marijuana 104: Responsibilities of Health Insurers. To be sure not to miss the article when it comes out, we invite you to subscribe to the Farrell Fritz New York Health Law Blog.

This blog post is the second in a series of articles discussing the current state of the law in New York regarding medical marijuana. To read the first post in the series, Medical Marijuana 101: The State of the Law in NY, click here.

One of the biggest questions that people have when discussing medical marijuana in New York is where can patients obtain medical marijuana products.

Before a patient can obtain medical marijuana products, he or she must first be issued a certification for medical marijuana by a practitioner, who is registered with the NYS Department of Health’s Medical Marijuana Program, and obtain a Registry Identification Card. Patients can then use that Registry Identification Card to visit a dispensing facility to obtain medical marijuana products. We’ll dive into the requirements imposed upon patients and certifying physicians in our next post and concentrate today on registered organizations and dispensaries.

Registered organizations are responsible for the manufacturing and dispensing of medical marijuana in New York State. At the time that the medical marijuana program was launched in 2016, New York approved five registered organizations: Columbia Care NY LLC, Etain, LLC, MedMen, Inc. (formerly known as Bloomfield Industries Inc.), PharmaCann LLC and Vireo Health of New York LLC (formerly known as Empire State Health Solutions).

On August 1, 2017, the NYS Department of Health announced that it has licensed five new companies to join the original five: Valley Agriceuticals, LLC, Citiva Medical LLC, PalliaTech NY, LLC, NYCanna LLC and Fiorello Pharmaceutics, Inc.

Valley Agriceuticals and Citiva are authorized to bring dispensaries to Brooklyn, Pallia and NYCanna are expected to open somewhere in Queens, and Fiorello Pharmaceutics is authorized to open a dispensary in Manhattan. Each of the new registered organizations received authority to open dispensing facilities in other delineated areas of New York as well. Under the Compassionate Care Act, each registered organization is authorized to have up to four dispensing facilities, meaning that there could be up to forty dispensing facilities statewide if each registered organization is fully developed.

Registered organizations must manufacture medical marijuana products in an indoor, enclosed, secure facility located in New York State and may only manufacture medical marijuana products in forms approved by the Commissioner of Health. These forms include liquid or oil preparations for metered oromucosal or sublingual administration or administration per tube; metered liquid or oil preparations for vaporization; and capsules for oral administration. Smoking, as of now, is not an approved route of administration. On August 10, 2017, the NYS Department of Health proposed broadening the acceptable forms to include ointments, patches, lozenges and chewable tablets.

A certified patient can go to any dispensing facility of a registered organization in New York. This provides greater options to patients as not every dispensing facility sells the same types of medical marijuana. There are currently two New York State-mandated products for medical marijuana which require set ratios of Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), the two main chemicals used in manufacturing medical marijuana. Those two products must be offered by each registered organization, but a registered organization may also offer other products at the dispensing facility that have varying ratios of THC to CBD. It is expected that other products will be offered over time.

In addition, certified patients who are unable to go to a dispensing facility may designate a caregiver who can go for them. Registered organizations are also permitted to offer delivery services to patients and designated caregivers to help expand access to those who are unable to travel to a dispensing facility.

As you might imagine, dispensing facilities are subject to a number of regulations in order to ensure that patient health is properly protected. Among other requirements, dispensing facilities must (1) have a licensed NYS pharmacist on site to directly supervise the facility when open, (2) not sell items other than medical marijuana products approved by the NYS Department of Health, (3) not allow the consumption of the medical marijuana by the patient at the facility, (4) not allow certified patients or their caregivers to consume any food or beverages at the facility unless necessary for medical reasons, (5) maintain a visitor log, and (6) firmly affix a patient-specific dispensing label approved by the Department of Health that is easily readable and includes a delineated list of items. The regulations allow dispensaries to provide up to a 30-day supply of medical marijuana to a certified patient.

Dispensing facilities, as well as the manufacturing facilities operated by registered organizations, must also meet a number of security regulations. Registered organizations must also provide an electronic report to the NYS Department of Health of all approved medical marijuana products that are dispensed within 24 hours after the medical marijuana was dispensed to the certified patient or designated caregiver.

Now that we have a basic understanding of registered organizations and dispensing facilities, check back soon for Medical Marijuana 103: Patient and Physician Regulations in New York State.

Effective March 1, 2017, the New York State Department of Financial Services promulgated regulations to help protect against cybercriminals and their efforts to exploit sensitive electronic data. These cybersecurity regulations apply to all individuals and entities that “operate under a license, registration, charter, certificate, permit, accreditation or similar authorization under the Banking Law, the Insurance Law or the Financial Services Law”, with a few exceptions.  This will undoubtedly result in insurance companies and other related healthcare entities, which hold sensitive patient health information, beefing up their internal and external rules and policies.  New York’s proactive stance should be taken with the utmost seriousness seeing that there are more than 400 cyberattacks each day over the internet, or almost 3 every minute.

The United States Congress has enacted a similar law to protect health information, the Health Insurance Portability and Accountability Act (“HIPAA”). However, because HIPAA was enacted and modified years prior to cybersecurity becoming a prominent threat to our society, HIPAA does not provide as much protection to patients’ electronic data as the New York regulations do.  HIPAA does provide important guidelines and safeguards to ensure the integrity and confidentiality of protected health information, but does not elaborate on many of the issues presented in New York’s cybersecurity regulations.

New York’s cybersecurity regulations require all “Covered Entities”, as defined in the regulations, to maintain a cybersecurity program to guard the confidentiality of Nonpublic Information, which includes a risk assessment and a comprehensive cybersecurity policy.  In addition, Covered Entities are now required to designate an individual to serve as the Chief Information Security Officer (“CISO”).  The CISO is tasked with overseeing, implementing and enforcing the Covered Entity’s cybersecurity policy, and is required to report, in writing and at least annually, to the Covered Entity’s Board of Directors or similar governing body.  The CISO’s report must include, as applicable, information on “(1) the confidentiality of Nonpublic Information and the integrity and security of the Covered Entity’s Information Systems; (2) the Covered Entity’s cybersecurity policies and procedures; (3) material cybersecurity risks to the Covered Entity; (4) overall effectiveness of the Covered Entity’s cybersecurity program; and (5) material Cybersecurity Events involving the Covered Entity during the time period addressed by the report.”

Compliance with the cybersecurity regulations will be transitioned over a two-year period with full compliance required by March 1, 2019.

The Medicaid Fraud Control Unit (MCFU) of the New York State Office of the Attorney General has recently issued restitution demand letters to providers for allegedly entering into percentage-based contracts with their billing agents. The MCFU letters cite the Medicaid Update March 2001, titled “A Message for Providers Using Service Agents as follows:

Billing agents are prohibited from charging Medicaid providers a percentage of the amount claimed or collected. In addition, such payment arraignments, when entered into by a physician, may violate the Education Law and State Education Department’s regulations on unlawful fee-splitting.

A physician will be guilty of misconduct if he or she permits:

any person to share in the fees for professional services, other than: a partner, employee, associate in a professional firm or corporation, professional subcontractor or consultant authorized to practice medicine, or a legally authorized trainee practicing under the supervision of a licensee. This prohibition shall include any arrangement or agreement whereby the amount received in payment for furnishing space, facilities, equipment or personnel services used by a licensee constitutes a percentage of, or is otherwise dependent upon, the income or receipts of the licensee from such practice, except as otherwise provided by law with respect to a facility licensed pursuant to article twenty-eight of the public health law or article thirteen of the mental hygiene law.

See Educ. Law §6530(19)*.

A physician is subject to professional misconduct charges if he or she has

directly or indirectly requested, received or participated in the division, transference, assignment, rebate, splitting, or refunding of a fee for, or has directly requested, received or profited by means of a credit or other valuable consideration as a commission, discount or gratuity, in connection with the furnishing of professional care or service . . .

See Educ. Law §6531.

The prohibition against fee-splitting is related to the state anti-kickback law which prohibits physicians from

[d]irectly or indirectly offering, giving, soliciting, or receiving or agreeing to receive, any fee or other consideration to or from a third party for the referral of a patient or in connection with the performance of professional services . . .

See Educ. Law §6530 (18).

Licensed professionals in New York State must review their contracts to verify that the compensation paid to their agents is not based on a percentage of fees for professional services.

*A similar rule applies to other licensed professionals. See N.Y. Rules of the Board of Regents §29.1(b)(4).

**In addition to the Federal Anti-Kickback Statute at 42 U.S.C. §1320a-7b(b), New York has enacted its own wide-reaching anti-kickback and anti-referral laws and regulations seeking to eliminate fraud and abuse in healthcare on a statewide basis. The state anti-kickback statue is set forth in the Social Services Law (See N.Y. Social Services Law § 366-d). The N.Y. Education Law addresses matters of professional misconduct rather than violations of fraud and abuse laws and regulations.

The Supreme Court recently allowed liability through the implied certification theory of the False Claims Act (FCA), which was raised and upheld in Universal Health Services, Inc. v. United States ex rel. Escobar. The decision provided for a new applicable standard and resolved the split among circuit courts on whether to recognize the theory.

In Escobar, a teenaged patient was receiving health services from a mental health facility. The patient had an adverse reaction to medication prescribed and died of a seizure. The parents later discovered United Health Services sought reimbursement from MassHealth (the Massachusetts State Medicaid Program) for mental health services provided at the facility by individuals who did not meet the standards for licensure and other requirements. The parents then filed a qui tam suit relying on the implied certification theory of liability. The District Court ruled against the parents finding the claims for reimbursement were not expressly false because the facility made no express statement regarding the service providers. United States ex. rel. Escobar v. Universal Health Services, 780 F.3d 504 (1st Cir. 2015). On appeal, the First Circuit rejected the bright line approach and determined that compliance with licensure and other MassHealth regulatory requirements were conditions of payment sufficient to support an FCA suit. United States ex. rel. Escobar v. Universal Health Services., 780 F.3d 504 (1st Cir. 2015)

The Supreme Court held that implied false certification is a proper basis for liability under the False Claims Act where (1) “the claim does not merely request payment, but also makes specific representations about the goods or services provided”, and (2) “the defendant’s failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths.” The Court focused on defining the FCA’s materiality standard as whether the government’s knowledge of the noncompliance “would have” affected their payment decision rather than “could have”. The Court further explained that whether an obligation was a condition of payment relates to, but is not dispositive of, materiality.

Now, after Escobar, FCA plaintiffs must overcome a more demanding materiality standard when relying on implied false certification to establish False Claims Act liability.

Special thanks to Law Clerk Joanna Lima for her assistance in preparing this blog post.