As we’ve discussed in previous blog posts, marijuana, whether used for medicinal or recreational purposes, is classified as a Schedule 1 drug under the Controlled Substances Act (CSA). The CSA prohibits the manufacturing, distributing, dispensing or possession of certain controlled substances, including marijuana and marijuana-based products and services. In addition, the CSA makes it unlawful to sell, offer for sale or use any facility of interstate commerce to transport illegal substances, including marijuana.

In August 2017, U.S. Senator Cory Booker (D-NJ) and Representative Barbara Lee (D-CA) introduced bills to both chambers of Congress – the Marijuana Justice Act of 2017 – that seek to remove marijuana completely from the list of controlled substances, making it legal at the federal level.

Last year U.S. Senator Ron Wyden (D-CA) was the first senator to co-sponsor the Marijuana Justice Act. On Wednesday, February 14, 2018, New York Senator Kirsten Gillibrand announced that she is also co-sponsoring the Marijuana Justice Act to end the federal prohibition on marijuana.

“Legalizing marijuana is a social justice issue and a moral issue that Congress needs to address, and I’m proud to work with Sen. Booker on this legislation to help fix decades of injustice caused by our nation’s failed drug policies,” Gillibrand said in a statement.

The Marijuana Justice Act aims to implement a number of reforms relating to marijuana. The most significant reform would be the removal of marijuana from the list of controlled substances in the CSA. Such a reform would effectively end the federal criminalization of marijuana.

Other reforms proposed by the Marijuana Justice Act include: (1) providing incentives to states to reduce racial disparities in connection with arrests made for marijuana; (2) expunging federal convictions relating to marijuana possession; (3) allowing individuals serving time in federal prison for marijuana-related offenses to petition the court for resentencing; and (4) developing a community reinvestment fund to invest in communities most impacted by the failed War on Drugs, such as by providing in-job training programs, educational opportunities, public libraries and community centers.

There is growing support for removal of marijuana as a Schedule I drug under the CSA, especially as courts have recently held that only the Drug Enforcement Agency (“DEA”) can make such a change.

Most recently, on February 26, 2018, U.S. District Judge Alvin Hellerstein in Manhattan ruled dismissed a lawsuit seeking to overturn the United States’ prohibition of marijuana on the grounds that the ban was unconstitutional. Judge Hellerstein ruled that the lawsuit must be dismissed because the plaintiffs had failed to use administrative procedures within the DEA to challenge the ban. Judge Hellerstein said his decision “should not be understood as a factual finding that marijuana lacks any medical use in the United States,” but, rather, that the authority to make that decision lies with the DEA, not with the court.

As of now the Marijuana Justice Act has not seen much movement in Congress. Since its introduction it has been read twice and then referred to the Committee on the Judiciary. It will be interesting to see if additional senators act to support the Marijuana Justice Act as the debate over the decriminalization of marijuana continues.

Filefax, Inc. (“Filefax”), an Illinois company that intimately handled sensitive Personal Health Information (“PHI”), paid $100,000 to the Department of Health and Human Services (“HHS”) to settle potential violations of the Health Insurance Portability and Accountability Act (“HIPAA”). The payment stemmed from, when still in business, Filefax allegedly improperly disclosing the PHI of approximately 2,150 people when not properly securing such information in an unlocked truck on Filefax property, as well as granting access to PHI to people who should not have been granted access. Pursuant to the Resolution Agreement, the court appointed receiver for Filefax did not admit liability on behalf of Filefax but, however, did agree to enter into a Corrective Action Plan to help mitigate potential exposure.

On its face, the Filefax case may appear to be just like other settlements with HHS resulting from a HIPAA violation, but this case is different for one critical reason—Filefax is no longer in business!

Yes, Filefax, a company no longer operating and which was involuntarily dissolved on August 11, 2017, settled these potential violations of HIPAA, making it clear that, just because the doors close, HIPAA still applies. Roger Severino, director of the Office of Civil Rights (“OCR”), the HHS enforcement arm of HIPAA, stated “[c]overed entities and business associates need to be aware that OCR is committed to enforcing HIPAA regardless of whether a covered entity is opening its doors or closing them. HIPAA still applies.”

Business owners, especially those that handle PHI on a day-to-day basis, must continue to take seriously the rules and guidelines HHS sets forth with respect to HIPAA and are on notice that penalties may still apply even if you are no longer conducting business. The Filefax case should serve as a stark warning to all business owners that you cannot escape liability and/or penalties under HIPAA by closing your doors.

Spurred in large part by the changing landscape of medicine, more and more medical professionals are seeking to become a part of something bigger. Often, they are under the misassumption that they can set up and run their practice like any other business – until New York State’s strong prohibition of the corporate practice of medicine comes knocking on their door.


According to a 1998 report from a meeting of the New York State Board of Regents, “[p]rofessional services can be offered only by a licensed person or an organization otherwise authorized by law.” Under New York State law, this means that professional services can only be offered within a professional service corporation (“PC”) or a professional limited liability company (“PLLC”). Article 15 of the New York Business Corporation Law permits the formation of a professional service corporation only if all shareholders (1) are licensees of one profession (Section 1503) and (2) practice only such profession (Section 1506). The prohibition of the corporate practice of medicine extends beyond medical doctors to include an array of licensed professionals, such as dentists, dental hygienists, optometrists, chiropractors, podiatrists, pharmacy, nursing, ophthalmic dispensing, speech-language pathology, audiology, respiratory therapy (and technology), occupational therapists (and assistants) and physical therapists (and assistants).

One area that is a common pitfall for professionals is the sharing of profits or “fee-splitting.” The prohibition of the corporate practice of medicine, codified in 8 CRR-NY 29.1, prevents professionals from directly or indirectly sharing profits or splitting fees with non-licensed professionals.   Most often this comes up in an arrangement where the PC or PLLC employs a management services organization to run its company in exchange for a percentage of revenue.[1] Such an arrangement runs afoul of the prohibition and, in order to comply, all services that the PC or PLLC receives should be paid at fair market value.


A violation of the prohibition on the corporate practice of medicine can result in prosecution, fines and penalties. As articulated by Eric T. Schneiderman, Attorney General of the State of New York, in In the Matter of Aspen Dental Management, Inc. (Assurance No: 15-103), the theory underlying the prohibition is that “medical and dental decisions should be made by licensed providers using their best clinical judgment, and should not be influenced by management companies’ shared interest in potential profits.” In Aspen Dental, the management organization – which was not a professional organization – was required to restructure so that it no longer received percentage of gross profit, no longer employed clinical staff, and no longer had discretion over how the individual offices were run. Moreover, Aspen Dental was required to pay a $450,000 civil penalty and pay an independent monitor to oversee the implementation of the settlement for three years.



It remains to be seen what, if any, changes are made to the prohibition on the corporate practice of medicine in New York as the world shifts to value based reimbursement; however, for the time being professionals should remain cautious, not only when structuring their corporate entities but also when engaging with outside service providers.


[1] Note also that for some providers, fee splitting may result in STARK and anti-kickback violations, among others.

The Department of Justice issued two memoranda at the start of 2018 that may have important effects on health care fraud investigations and prosecutions under the False Claims Act.

The first, Factors for Evaluating Dismissal Pursuant to 31 U.S.C. 3730(c)(2)(A), was issued by Michael Granston, Director of the DOJ Commercial Litigation Branch, Fraud Section, and encourages DOJ attorneys to seek dismissal of a relator’s complaint if the government is declining to intervene in the case.  The memorandum describes the statute authorizing dismissal as “an important tool to advance the government’s interests, preserve limited resources, and avoid adverse precedent”, and it provides a non-exhaustive list of factors that DOJ attorneys should use as a basis for dismissal:

  • Does the qui tam complaint lack merit, whether based on an inherently defective legal theory or frivolous factual allegations?
  • Does the qui tam action duplicate a pre-existing government investigation and add no useful information?
  • Does the qui tam action threaten to interfere with an agency’s policies or the administration of its programs?
  • Is dismissal necessary to protect the government’s litigation prerogatives?
  • Is dismissal necessary to safeguard classified information?
  • Are the government’s costs in monitoring or participating in a qui tam action continued by the relator likely to exceed any expected gain?
  • Do the relator’s actions frustrate the government’s efforts to conduct a proper investigation?

The government has sought to dismiss declined qui tam complaints in the past, but more often has allowed the relator to go ahead with the case.  The Granston Memorandum emphasizes the advantages to the government in ending non-intervened qui tam cases early, particularly for saving government resources and avoiding adverse decisions from the Court.  If aggressively followed, this policy may result in less False Claims Act cases proceeding to litigation.

The second memorandum, Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases, was issued by former Associate Attorney General Rachel Brand, and follows a November 2017 memorandum from Attorney General Sessions that prohibited DOJ components from issuing guidance documents that would effectively bind the public without undergoing the rulemaking process.  The Brand Memorandum extends this concept to government False Claims Act theories based on a failure to follow agency guidance documents.  “Department litigators may not use noncompliance with guidance documents as a basis for proving violations of applicable law” in affirmative civil enforcement cases.  The policy seeks to avoid allowing guidance documents to create binding requirements that do not exist by statute or regulation.  The government must prove noncompliance with the statute or regulation, and cannot use noncompliance with an agency guidance document as a substitute.  The Brand Memorandum will limit government theories of False Claims Act liability that are based on the violation of agency guidance documents as opposed to the relevant statute or regulation.

New York is currently taking steps to investigate the possible legalization of recreational marijuana in New York.

In July 2017 we talked about the Marijuana Regulation and Taxation Act (“MRTA”), S.3040B/A.3506B, in Medical Marijuana 101: The State of the Law in NY. At that time, the bill, which seeks to regulate the growth, taxation, and distribution of recreational marijuana in New York, was sitting idly in the Senate Finance Committee. On January 11, 2018, however, the New York State Assembly Standing Committees on Codes, Health, and Alcohol and Drug Abuse held a public hearing to discuss the MRTA. The hearing reviewed the potential for allowing the regulated sale and adult possession of marijuana in New York and how it would affect public health and the criminal justice systems. A transcript and video recording of the hearing can be found here.

The hearing was held just days before Governor Andrew Cuomo’ annual budget address on January 16, 2018. During his budget address Governor Cuomo stated that New York should undertake a study of the possible impacts of legalizing recreational marijuana. The study would be undertaken by the NYS Department of Health, with input from state police and other state agencies, to determine the health and economic impacts of legalizing the drug.

“New Jersey may legalize marijuana. Massachusetts already has. On the other hand, Attorney General Sessions says he’s going to end marijuana in every state. So you have the whole confluence of different information,” Cuomo said during his presentation to the Legislature.  “I think we should fund [the Department of Health] to do a study. Let them work with state police and other agencies. Look at the health impact and economic impact,” he said during his address.

This is a change from Governor Cuomo’s position from last February in which he told reporters that he remained “unconvinced on recreational marijuana.”

This change of heart, however, shouldn’t come as a surprise to most New Yorkers. Momentum for marijuana reform has been building steadily in New York since the passage of the Medical Marijuana Act in 2014. A poll of New York voters released in late 2017 showed that over 62% of New Yorkers support making marijuana use legal in New York for adults over the age of 21. In addition, more than 60% of those polled stated that they prefer using revenue from a legal marijuana market to address New York’s budget deficit over other options such as increasing sales taxes, increasing highway and bridge tolls and cutting public service funds.

The recreational use of marijuana is already legal in a growing number of states, including Washington, Oregon, Nevada, California, Alaska, Colorado, Maine, Massachusetts and the District of Columbia.

In New Jersey, newly elected Democratic governor Phil Murphy stated in his inauguration speech that his vision for a “stronger and fairer New Jersey … includes a process to legalize marijuana.” He aims to legalize marijuana within his first 100 days in office.

In Massachusetts, Gov. Charlie Baker signed a bill legalizing recreational marijuana on July 28, 2017. The law permits adults over the age of 21 and who are not participating in the state’s medical marijuana program to legally grow up to six plants and to possess personal use quantities of marijuana up to one ounce and/or up to 5 grams of concentrate. The regulations also allow for the licensing of commercial marijuana production and retail sales. Regulations with regard to the commercial marijuana market will go into effect on July 1, 2018.

In January 2018 Vermont became the first state in the country to legalize marijuana by legislation rather than through a citizen referendum. The new law, H. 511, takes effect on July 1, 2018. Similar to the regulations passed in Massachusetts, the Vermont law authorize adults over the age of 21 to legally possess up to one ounce of marijuana, and/or to privately cultivate up to six marijuana plants. The regulations also impose new civil penalties for consuming marijuana while driving, and imposes additional penalties for those who operate a motor vehicle impaired with a minor in the vehicle.

What happens in New York remains to be seen, but it is clear that the debate over whether to legalize the recreational use of marijuana is just getting started.

2018 Government Shutdown

Just as everyday Americans were preparing their lives for a second United States government shutdown since the turn of the New Year, President Donald J. Trump signed into law a bipartisan (well, as bipartisan as it gets with this Congress) budget deal, focusing on some of the core issues facing us today and, in particular, those directly impacting healthcare.

While pundits, analysts and deficit hawks will argue back and forth about the excessive spending and items that Congress and the administration missed on this deal, one issue that Congress finally started allocating resources to and which hits home for so many people is the opioid crisis—allocating $6 billion to help combat this tragic public health emergency.  Enough is enough when more than 110 babies have tragically died since 2010 due to either being born dependent on opioids or for lack of care from their parents.

Some other important items, among others, in the budget deal include:

  • Re-authorizing community health centers, which serve over 25 million people, for an additional 2 years with approximately $7 billion in funding;
  • Allocating $4 billion to help Veterans Administration hospitals provide the care that our veterans rightfully deserve; and
  • Extending the Children’s Health Insurance Program (CHIP) for 10 years.

Just after reaching the deal, House Speaker Paul Ryan said “[u]ltimately, neither side got everything it wanted in this agreement, but we reached a bipartisan compromise that puts the safety and well-being of the American people first.” Even though it took a second, but brief, government shutdown and many continuing resolutions to light a fire under Congress to pass a budget, the budget they passed is an important step forward for our Country, especially when it comes to improving our healthcare system.

As discussed in our January 5th blog post, the Cole Memorandum was rescinded by Attorney General Jeff Sessions on January 4th of this year.   The Cole Memorandum had served to formally announce the DOJ’s policy that it would not interfere with medicinal marijuana legalized under state law, despite marijuana’s continued illegality for all purposes under federal law. With the rescission of the Cole Memorandum, federal prosecutors are now free to determine to what extent they will enforce federal law against the state-legalized medical marijuana industry.

However, the effect of the change in policy reaches further than to just the cultivators, manufacturers and distributors of medicinal marijuana products. Pursuant to the Controlled Substances Act, not only is it illegal to manufacture, distribute or dispense marijuana for any purpose – but it is also illegal to aid someone in doing so. Therefore, the DOJ is now free to prosecute anyone “aiding” in a medical marijuana business, for example, giving legal advice.

Probably of greater practical concern to attorneys than criminal prosecution is the tremendous amount of uncertainty as to how the change in policy will impact the ethics surrounding the representation of medical marijuana clients. Most, if not all, states have ethical rules that specifically prohibit a lawyer from assisting a client in illegal conduct. These rules do not distinguish between conduct that is illegal under federal law but expressly permitted under state law.

New York Rule of Professional Conduct 1.2 provides that “[a] lawyer shall not counsel a client to engage, or assist a client, in conduct that the lawyer knows is illegal or fraudulent, except that the lawyer may discuss the legal consequences of any proposed course of conduct with a client.” While it is generally undisputed that an attorney may advise a client about what state law provides – for example, filing requirements – an attorney arguably would be violating the Rules of Professional Conduct by, for example, assisting a client in negotiating a marijuana distribution contract.

Ethics boards in some states, including New York, have used the Cole Memorandum as the decisive factor to conclude that providing legal advice related to legalized medical marijuana businesses does not violate ethics rules. To a lesser extent, some states, including New York, have also relied on the theory that state ethics rules are intended to promote state policy – and by approval of the state medicinal marijuana law, a state has expressed its state policy on the matter, yielding no ethical violation.

It remains to be seen what impact the rescission of the Cole Memorandum will have on the ethics opinions of various states that are based heavily upon the prior policy of federal non-enforcement. For now, we can still find comfort in the Rohrabacher-Blumenauer amendment to the federal budget, which currently continues in effect until February 8 and maintains that federal funds (including those allocated to the DOJ) cannot be used to prevent states from “implementing their own state laws that authorize the use, distribution, possession or cultivation of medical marijuana.”

It’s flu season again. Your PCP at WPMG is thinking of you!

So began the health care provider’s text message that prompted this month’s Second Circuit decision applying the Telephone Consumer Protection Act to a flu shot reminder, Latner v. Mount Sinai Health System, Inc.

Plaintiff had gone to defendant West Park Medical Group (WPMG) in 2003 for a routine health examination. While there, he provided contact information including his cell phone number, and signed, among other forms, a notification record that consented to defendants using his health information “for payment, treatment and hospital operations purposes.”

In 2011, defendants hired a third party to send mass messages, including flu shot reminder texts for WPMG. In 2014, plaintiff received the text message above, which also stated: Please call us at 212-247-8100 to schedule an appointment for a flu shot. Defendants had sent flu shot reminder texts to all active patients of WPMG who had visited the office within the prior three years. Plaintiff had visited the office in 2011, declining immunizations.

Plaintiff alleged a violation of the Telephone Consumer Protection Act (TCPA), which makes it unlawful to send texts or place calls to cell phones through automated telephone dialing systems, unless the recipient consents or an exemption applies.

The Second Circuit engaged in a two-step process to decide that the defendants did not violate the TCPA. First, the Court held that the flu shot reminder text message was within the scope of an FCC Telemarketing Rule providing that written consent was not needed for text messages that deliver a health care message made by, or on behalf of, a HIPAA covered agency.

The Court next determined that, although the FCC Telemarketing Rule exempts written consent, text messages within the healthcare exception are still covered by the TCPA’s general consent requirement. The Court held, however, that plaintiff had given his prior express consent by providing his cell phone number, acknowledging receipt of privacy notices, and agreeing that defendants could share his information for treatment purposes and to recommend possible treatment alternatives or health-related benefits and services.

The lesson of this case: the pile of forms you sign on the clipboard in the waiting room may lead to texted health care messages down the road.

Despite numerous states having legalized medical marijuana, and a handful of others having legalized marijuana for recreational use, it still remains impossible to obtain a U.S. federal trademark registration for marijuana products or related goods or services.

The U.S. Patent and Trademark Office (USPTO) is the federal agency charged with granting U.S. patents and registering trademarks. The USPTO registers trademarks based on the commerce clause of the Constitution (Article I, Section 8, Clause 3) and registration is governed under various rules of practice and federal statutes.

The USPTO Trademark Manual of Examining Procedure (TMEP) Section 907 explains that under Trademark Rule of Practice 2.69, “[u]se of a mark in commerce must be lawful use to be the basis for federal registration of the mark. . . . Generally, the USPTO presumes that an applicant’s use of the mark in commerce is lawful and does not inquire whether such use is lawful unless the record or other evidence shows a clear violation of law, such as the sale or transportation of a controlled substance.”

As we’ve discussed in previous blog posts, marijuana, whether used for medicinal or recreational purposes, is classified as a Schedule 1 drug under the Controlled Substances Act (CSA). The CSA prohibits the manufacturing, distributing, dispensing or possession of certain controlled substances, including marijuana and marijuana-based products and services. In addition, the CSA makes it unlawful to sell, offer for sale or use any facility of interstate commerce to transport illegal substances, including marijuana.

As a result of the CSA, U.S. trademark applications related to marijuana or marijuana related goods and services will be refused registration under TMEP Section 907. TMEP Section 907 further provides that “[r]egardless of state law, the federal law provides no exception to the above-referenced provisions for marijuana for ‘medical use.’” Recent decisions issued by the USPTO continue to deny the federal registration of trademarks relating to marijuana and related goods and services despite the legality of such products and services under state law.

Trademarks that reference marijuana but that are used in commerce on lawful products, such as clothing, may be registered with the USPTO. For example, the trademark “MARIJUANAMAN” was registered by the USPTO as the mark will be used in connection with books about cannabis. Similarly, the trademark THE MARIJUANA COMPANY was approved in connection with the mark’s use on clothing.

Since federal registration is not permitted for trademarks that cover the sale or transportation of marijuana, such trademark applicants must rely on state trademark filings for the registration of their trademarks. This has become an important issue since so many states have now enacted legislation legalizing the medical – and in some cases, recreational – use of marijuana.

State trademark registrations are more limited in scope than federal trademark registrations as they don’t offer national protection or afford a registrant a presumption of ownership and validity of the underlying trademark on a national level. They are relatively inexpensive to obtain, however, and can afford the registrant at least certain benefits under state law. States like Washington, Oregon, Nevada and Colorado already allow for the registration of cannabis-related marks.

Nevada, for example, enacted legislation governing the use of names, logos, signs and advertisements by medical marijuana establishments. Pursuant to NAC 453A.402, any such names, logos, signs and advertisements must be approved by the Administrator of the Division of Public and Behavioral Health. In addition, Nevada has established guidelines which provide design guidelines for medical marijuana establishments. The guidelines specify, among other things, that the overall appearance of the mark or advertisement must not be appealing to minors; not contain cartoon-like figures or illustrations; not contain humor and must avoid script, decorative or gimmicky fonts. The use of of marijuana slang in the mark or advertisement, such as pot or weed, is also strictly prohibited.

Most recently, as of January 1st, 2018, customers may also register cannabis-related marks with the California Secretary of State. In order to register the mark California requires that (1) the mark be lawfully in use in commerce within California; and (2) the mark match the classification of goods and services adopted by the USPTO. To be lawfully using the mark in commerce within California requires that the registrant be licensed by California to provide the goods and services for which he or she is seeking protection and that such goods and services have already been sold to the public. Unlike registration of a trademark at a federal level, California does not have an intent-to-use trademark application. As such, the mark must be in use prior to registering the mark with the Secretary of State.

New York has not yet enacted any special legislation or guidelines relating to the registration of marijuana-related trademarks with the New York Secretary of State. That may soon change, however, as more and more states start to allow state registration of marks relating to marijuana and marijuana-related goods and services.

On January 5, 2018, the United States Department of Health and Human Services released for public comment a draft Trusted Exchange Framework, which seeks to accomplish interoperability with respect to patients’ Electronic Health Information (“EHI”) through the creation of Health Information Networks (“HINs”). The 21st Century Cures Act, which Congress enacted in 2016, has the goal of creating a trusted exchange focusing on streamlining patient EHI and establishing a network designed to “achieve a system where individuals are at the center of their care and where providers have the ability to securely access and use health information from different sources.” The Trusted Exchange Framework is the federal government’s attempt to achieve that goal.

The draft Trusted Exchange Framework is broken down into two parts:

Part A—Principles for Trusted Exchange

Part B—Minimum Required Terms and Conditions for Trusted Exchange

Part A sets forth and relies on six principles:

(1) Standardization (adherence to industry standards and best practices);

(2) Transparency (an open free flowing exchange);

(3) Cooperation and Non-Discrimination (collaboration from all stakeholders);

(4) Privacy, Security, and Patient Safety (data protection and integrity);

(5) Access (conveniently obtain EHI); and

(6) Data-driven Accountability (streamlined process for a cohort of patients to help lower cost of care).

These principles are guidelines qualified HINs need to follow to help build a trusting relationship between participants and patients and, without adherence to this foundation, a new modernized system cannot properly flourish.

Part B sets forth the minimum required terms and conditions participants must adopt and follow to ensure a trusted exchange of EHI. This is accomplished through a trusted exchange framework and common agreement (“TEFCA”). The TEFCA seeks to ensure, among other things, that there is “[c]ommon authentication processes of trusted health information network participants, [a] common set of rules for trusted exchange, and [a] minimum core of organizational and operational policies to enable the exchange of EHI among networks.” A sample TEFCA can be found in the draft Trusted Exchange Framework.

In sum, it is clear that the federal government is finally taking a serious look at how our healthcare system can become more efficient and modernized in our ever-changing society. Putting into place a final Trusted Exchange Framework, with input from all stakeholders, is a great step towards reaching that goal.

The deadline for public comment is February 18, 2018.