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.

While marijuana is legal for medical and, in some instances recreational, use under the laws of 29 states plus the District of Columbia, under federal law it remains illegal. Yet, for the last several years, this lingering federal illegality has not seemed to chill entry into the industry – thanks in large part to the Cole Memorandum. On the heels of the January 4 rescission of the Cole Memorandum, as well as two additional memos related to marijuana enforcement policy, all of that might change.

A federal statute, the Controlled Substances Act (the “CSA”) makes it illegal to manufacture, distribute or dispense marijuana for any purpose. Under the CSA, marijuana is a Schedule 1 drug, meaning that under federal law marijuana is believed to have no currently accepted medical use and a high potential for abuse. Moreover, the Schedule 1 classification extends to all elements of the cannabis plant, including extracts and derivatives thereof. No exceptions exist in the CSA for medicinal use or use in states where marijuana has been legalized.

However, in 2013, the U.S. Department of Justice (“DOJ”) issued the Cole Memorandum, which states that its general policy is not to interfere with the medicinal use of marijuana under state law. The Memorandum set forth certain principles underpinning DOJ enforcement of the CSA with respect to marijuana. Although the DOJ said it would continue to prosecute persons or organizations whose conduct interferes with any one or more of these principles, regardless of state law, the memorandum went on to declare that where state law effectively mitigates the concerns of the DOJ, the Department will refrain from prosecution.

Since the change in administration in 2017, there has been an increasing sensitivity to a shift in DOJ policy on enforcing the CSA against “legalized” marijuana businesses. Attorney General Jeff Sessions has publicly discussed his harsh stance on marijuana and the potential for increasing federal enforcement of the federal law regarding marijuana – despite what state law provides. In fact, in May 2017 he sent a letter to certain political leaders advising of his desire to do so.

Sessions has now gone a step further and rescinded the Cole Memorandum, leaving federal prosecutors free to determine to what extent they will enforce the CSA against state-legalized marijuana businesses. A copy of the release can be found here and a copy of the memorandum can be found here.

While likelihood of prosecution will vary from jurisdiction to jurisdiction based upon the position of the particular U.S. Attorney in charge of the district, it is clear that the rescission will have a broader impact than just the potential of prosecution of those involved in the industry. As discussed in our November 27, 2017 post, Cannabis Business? The Impact of Federal Law Might reach Further than You Think, the CSA and federal illegality of marijuana has a far-reaching impact on those setting up or running marijuana businesses that are legal under state law. It is anticipated that the rescission of the Cole Memorandum will, among other things, further impair the ability of those in the marijuana business to obtain leases, financing, and perhaps even legal assistance.

State and federal representatives of several states have already publicized their positions on the January 4 memorandum, with many being unfavorable. It would not be surprising if political leaders mobilized quickly to protect the cannabis industry, which has already injected over $20 billion into the U.S. economy and is expected to increase that number to about $70 billion by 2021. In the short term, those in the industry can continue to find some comfort in the Rohrabacher-Blumenauer amendment to the federal budget, which continues in effect until January 19 and maintains that federal funds cannot be used to prevent states from “implementing their own state laws that authorize the use, distribution, possession or cultivation of medical marijuana.” In the meantime, we will all be waiting with baited breath to see the responses of state and federal leaders.

As we previously discussed in Medical Marijuana 103: Patient and Practitioner Regulations in New York State, practitioners in New York must be registered with the New York State Department of Health (“DOH”) in order to certify patients for medical marijuana use. The DOH maintains a list of registered practitioners on its website, however such list is woefully incomplete. As of the date of this writing there are over 1,360 providers statewide that are registered to certify patients for medical marijuana, but only 32 percent are included on the public list maintained by the DOH.

On Wednesday, November 28, 2017, Governor Andrew Cuomo signed a bill which requires the the DOH to list on its website all practitioners who are certified to recommend medical marijuana to patients.

Sen. Diane Savino (D-Staten Island), the primary sponsor of the bill, stated that one of the biggest complaints from patients in the medical marijuana program was finding a registered doctor.

“People complained that it was difficult to find a doctor near them so they could  be certified as a patient. Because the Department of Health kept the list proprietary, it made it that much harder for patients,” said Senator Savino.

A vote on the bill was held in June 2017, with 62 senators voting in favor of the bill and only 1 senator opposing it. The bill requires that the name, contact information, and other information relating to practitioners registered with the DOH to certify patients for medical marijuana be public information and that the information be maintained on the DOH’s website in searchable form. There is an exception, however – practitioners may still opt-out if they do not wish for their information to be public by informing the DOH in writing. The new requirements will be implemented sixty (60) days after the bill was signed into law by Governor Cuomo.

Sen. Savino was also the main proponent of the bill signed on November 11, 2017 by the Governor which adds post traumatic stress disorder to the list of qualifying conditions treatable with medical marijuana in New York State. The date on which the bill was signed into law is no coincidence, as veterans groups in particular had urged Governor Cuomo to allow those with PTSD to use medical marijuana. According to the Department of Veterans Affairs, about eight million adults suffer from PTSD in any given year, including tens of thousands of Afghanistan and Iraq veterans. Somewhere between 11% and 20% of those vets will suffer from it each year.

Stemming from the recent drinking water crisis in Flint, Michigan, which has had life-lasting effects for many of its residents, including children, due to unsafe lead-related toxicity levels in the drinking water, New York State Governor, Andrew M. Cuomo, announced that various New York municipalities were awarded $20 million dollars in the aggregate to replace lead service lines as part of the New York Clean Water Infrastructure Act of 2017 (the “Act”). The Lead Service Line Replacement Program (the “LSLRP”), a critical part of the Act, provides $2,445,452 to Long Island, including $611,363 to the City of Glen Cove and $611,363 to the Town of Hempstead. Other awardees include New York City ($5,323,904), Buffalo ($567,492), as well as many other cities, towns and counties throughout the state.  In his press release, Governor Cuomo stated “[t]hese critical improvements to New York’s drinking water infrastructure are vital to protecting public health and to laying the foundation for future growth and economic prosperity in these communities”.

The LSLRP was introduced in 2017 and is intended to provide funding to municipalities to replace residential lead service lines, especially those that have corroded, from the public water system. The program empowers the New York State Department of Health to award funds to certain municipalities determined by the “percentage of children with elevated blood levels, median household income, and the number of homes built before 1939”. In fact, homes built before 1930 are more likely to contain lead in its pipes because at that time the government neither regulated this area nor the applicable construction practices.

In addition to the Act, New York has increased its attention to this cause, especially focused on children, who are most at risk for lead-related negative health effects, by requiring health providers to test every child for lead in his or her blood when reaching 1 and 2 years old. Further, in 2016, Governor Cuomo took a bold step by requiring all public schools to test their water for lead as well as mandating those results be made public.

It appears that Governor Cuomo and the New York State legislature have learned the very valuable lessons their counterparts in Michigan have taught us, and the important steps our government has since taken will help ensure the better health and quality of life for all of us that live in the Empire State.

Everyone involved, or thinking about becoming involved, in the cannabis business is aware of the conflict between the laws of those states legalizing marijuana and the Controlled Substance Act (the “CSA”).  The CSA is a federal law making it illegal to manufacture, distribute or dispense a controlled substance.  For purposes of the CSA, marijuana is classified as a Schedule 1 controlled substance – making it illegal under federal law to be engaged in the marijuana business regardless of what state law provides.

The obvious consequence of this conflict of laws is the potential for federal prosecution for engaging in the marijuana business.  However, the not-so-obvious practical consequences reach further than you might think.  For example,

  • Taxes. Section 280E of the Internal Revenue Code, originally targeted for illegal drug dealers, prohibits cannabis businesses from deducting typical business expenses, such as advertising and rent.
  • Leases.  Most leases have covenants against “illegal activity,” which enables landlords to evict marijuana business tenants.  Moreover, many landlords are unwilling to rent to marijuana businesses, despite their legality under state law, for fear of losing their property in a federal civil asset forfeiture action.
  • Banking. In 2014 the Department of Treasury issued guidance for financial institutions that want to do business with the marijuana industry.  Up until that time, banks were reluctant to deal with the marijuana business due to the Financial Crimes Enforcement Network (FinCEN), which requires banks to investigate their customers and to refrain from negligently or knowingly doing business with bad actors.  Today, banks are safe if they follow some pretty onerous rules.  Many banks choose not do business with the industry rather than comply with the diligence and monitoring requirements set forth by the Department of Treasury.
  • Commercial loans. Commercial loans are difficult to obtain without providing collateral; however, in a marijuana business, banks are not allowed to seize or possess the primary asset of a marijuana business – the marijuana – under federal law. Often a marijuana business will not have many other assets that are valuable enough to act as security for financing.
  • Trademarks. Because marijuana is illegal under the CSA, and because the United States Patent and Trademark Office will not register a mark if the applicant cannot show lawful use of the mark in commerce, it is nearly impossible to secure federal registration of a marijuana-related mark (although marks for ancillary products might be obtained).
  • Federal Water. Many areas in the western United States are served by the Federal Bureau of Reclamation, which manages water and power to farmers.  The Bureau has advised that it will report to the Department of Justice any marijuana farmers who use federal water to irrigate their crops.
  • Bankruptcy. At least two courts have held that marijuana businesses cannot take advantage of federal bankruptcy laws.  The rationale is that, because marijuana is illegal under federal law, granting relief under another provision of federal law for the same activity would be “administering the fruits and instrumentalities of Federal criminal activity.”
  • Access to Federal Courts. If you enter into a contract with a marijuana business and need to sue in federal court, will you be able to?  This question has yet to be answered; however, if the prohibition against bankruptcy relief serves as guidance, the outcome is likely not favorable to marijuana businesses.

It is clear that federal law creates many obstacles to establishing and effectively managing a marijuana business.  Those in the industry should plan carefully and seek legal advice as to how to best mitigate the risks arising from the conflict between state and federal laws.

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 Medicare, 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.