Category: Florida

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Florida’s New Medical Marijuana Law: What Physicians and Entrepreneurs Need to Know

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The Legislation implementing the medical marijuana amendment Florida voters approved last fall is on its way to the Governor.  On June 9, 2017,  during a special session, the Florida Legislature passed SB 8A and SB 6A, implementing Article X, section 29 of the Florida Constitution.  Florida Governor Rick Scott is expected to sign both bills into law and new laws will become effective immediately upon signature.

The following are among the key provisions in Florida’s new medical marijuana use law:

  • Qualifying Medical Conditions. To qualify for medical marijuana, a patient must be certified by a licensed Florida physician as having at least one of the following qualifying conditions:
    • Cancer
    • Epilepsy
    • Glaucoma
    • HIV/AIDS
    • PTSD
    • ALS
    • Crohn’s Disease
    • Parkinson’s Disease
    • Multiple Sclerosis
    • A condition of the “same kind or class” (though the precise meaning of this phrase is not further defined)
    • Patients also qualify if they have chronic pain related to a qualifying condition or are terminally ill
  • Physician Certification. To recommend medical marijuana, a physician must diagnose a patient with a qualifying condition and conclude the medical use of marijuana would likely outweigh the potential health risks to the patient. The physician must be physically present in the same room as the patient when conducting this examination.  Click here for our prior discussion of Florida medical marijuana and telemedicine examinations.
  • Re-Certification and Exams. Once the initial certification is issued, the physician must re-evaluate the existing qualified patient at least once every 30 weeks (210 days) before issuing a new certification.
  • No Waiting Period. The 90-day waiting period previously required under the 2014 Compassionate Use law no longer applies.  A qualifying patient may receive a medical marijuana certification during his or her first visit with a physician.
  • Informed Consent. A certifying physician must obtain the patient’s informed written consent for medical use of marijuana each time the physician issues a certification for the patient.
  • 70-Day Supply. Patients can obtain a marijuana certification for a 70-day supply, with two refills (i.e., a maximum supply of 210 days).  The law requires the Florida Department of Health to issue regulations that quantify a daily dose amount when calculating that 70-day supply.  Once the patient has exhausted his or her supply, the patient must obtain a new physician certification.
  • Medical Marijuana Use Registry. The Department of Health will create an online medical marijuana use registry for physicians and patients.  Physicians are responsible for checking the registry to ensure their patient is listed in the registry and must document in the registry that the patient has been certified for medical marijuana use.
  • Patient Registration; Identification Cards. Before obtaining medical marijuana, patients must: 1) provide proof of Florida residency, 2) be registered with the Department of Health in the medical marijuana use registry, and 3) possess a medical marijuana use registry identification card.  No later than October 3, 2017, the Department of Health will issue medical marijuana use registry identification cards for qualified patients.  These cards must be renewed annually.
  • No Smoking. The law prohibits the administration of marijuana in a form for smoking, seeds, or flower (except for flower in a sealed, tamper-proof receptacle for vaping), but allows for edibles and vaping.
  • Pregnant Women and Minors. A physician may only issue low-THC cannabis to a patient who is pregnant.  If a patient is younger than 18 years of age, a second physician must concur with the certification for medical marijuana to be dispensed to the patient.
  • Tax Exempt. Like other medications in Florida, purchases of medical marijuana and marijuana delivery devices will be exempt from state sales-tax.
  • Physician Course and Examination. Before being qualified to certify patients for medical marijuana, a physician must complete a two-hour course and exam administered by the Florida Medical Association or the Florida Osteopathic Medical Association.  Physicians who have already taken a medical marijuana course under the former Compassionate Use law must still take this new course and examination within 90 days of the course becoming available.
  • No Financial Interest. Physicians who certify patients for medical marijuana cannot be employed by, or have any direct or indirect economic interest in, a medical marijuana treatment center or marijuana testing lab.
  • Emergency Rules. The Florida Department of Health will adopt emergency rules necessary to implement the new law.  According to Amendment 2, the Department of Health has until July to issue rules.

It is important to note federal law still criminalizes the possession, use, and sale of marijuana.  The new Florida law does not immunize violations of such federal law or any non-medical use, possession or production of marijuana.  We will continue to monitor changes to Florida regulations on this issue.

For more information on other developments in health care laws affecting physicians, hospitals, and other providers, including the team, publications, and other materials, visit Foley’s Health Care practice.

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Florida’s New Medical Marijuana Law and Telemedicine Exams

Following a special session, the Florida Legislature on June 9, 2017 passed two important bills regarding medical marijuana in the Sunshine State: SB 8A and SB 6A. Together, these bills implement Article X, section 29 of the Florida Constitution, which was added after voters approved Amendment 2, expanding the medical use of marijuana for qualifying patients.  Florida Governor Rick Scott is expected to sign both bills into law.  The new laws would become effective immediately upon signature.

Among the more than 80 pages of legislation, there is one small sentence with big implications for telemedicine and virtual care providers.  Under the new law, the physician issuing a medical marijuana certification must be physically present in the same room as the patient when conducting the certification examination – meaning physicians may not issue a certification for medical marijuana via a telemedicine exam.  For the foreseeable future, Florida residents seeking medical marijuana prescriptions will be limited to in-person examinations.

The statutory language is as follows:

(4) PHYSICIAN CERTIFICATION.—

(a) A qualified physician may issue a physician certification only if the qualified physician:

1. Conducted a physical examination while physically present in the same room as the patient and a full assessment of the medical history of the patient.

Since last year, the Florida Board of Medicine has been considering prohibiting physicians from ordering medical marijuana via telemedicine.  In December 2016, the Board issued a proposed amendment to its telemedicine regulations to clarify that physicians may not order medical cannabis or low-THC cannabis via telemedicine.  The Board subsequently held public hearings on the issue, with a third hearing scheduled for August 4, 2017.  It is unclear how the Board will proceed on its proposed regulation, as the new statute also charges the Department of Health, the Board of Medicine, and the Board of Osteopathic Medicine to adopt rules underneath the law.

Some states, like California, do not prohibit telemedicine-based examinations for medical marijuana, while others, like Colorado, require an in-person examination prior to recommending medical marijuana.  Even in states that allow telemedicine-based examinations for medical marijuana, providers should keep in mind that the examination for the condition for which medical marijuana is being recommended must be an appropriate prior examination and meet the standard of care.

It is also important to note federal law still criminalizes the possession, use, and sale of marijuana.  The new Florida law does not immunize violations of such federal law or any non-medical use, possession, or production of marijuana.  We will continue to monitor changes to Florida regulations on this issue.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.

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Florida Board of Medicine to Hold Another Hearing on Telemedicine and Medical Marijuana Rules

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On August 4, 2017, the Florida Board of Medicine will hold a third public hearing to discuss its proposed amendment to Florida’s telemedicine practice rules regarding medical marijuana. The Board held two prior public hearings, after which it delayed implementation of the rule for further consideration.

Notice of the upcoming public hearing comes only days after state lawmakers failed to pass a medical marijuana bill.  Absent a special session of the Florida Legislature, the Department of Health’s Office of Compassionate Use is now tasked with creating rules to implement Amendment 2.  Amendment 2, passed by voters last Fall, changed the Florida Constitution to allow the medical use of marijuana for individuals with debilitating medical conditions as determined by a licensed Florida physician.  The Department of Health released proposed rules on January 17, 2017, but those rules were criticized by advocates as not aligning with the changes to the Florida Constitution made by Amendment 2.  The Department of Health has until July to issue final regulations.  The Board of Medicine’s proposed rule is distinct from, and does not substitute, the Department’s proposed rule.

What Will the Board’s Proposed Rule Do?

The Board’s proposed rule would prohibit physicians from ordering medical marijuana via telemedicine. The amendment would add a new Section (5) to the Standards for Telemedicine Practice under 64B8-9.0141, F.A.C. If the proposed amendment is finalized, the regulation would state as follows: “(5) Medical cannabis or low-THC cannabis, as defined by s. 381.986, F.S., may not be ordered by means of telemedicine.”

Why is the Hearing and Proposed Rule Important?

Interested physicians, providers, and entrepreneurs may want to attend the public hearing, both to learn more about the Board’s position on medical marijuana and telemedicine, understand the implications if the proposed rule were to be enacted, and to contribute their perspectives to inform the Board’s discussion. Some points of potentially-useful clarification participants might discuss at the hearing include, for example:

  • Whether or not it is appropriate to limit the use of telemedicine based on the physician’s choice of recommended treatment (e.g., medical marijuana vs pharmaceutical prescriptions), rather than based on the applicable standard of care and the patient’s clinical condition(s).
  • Whether or not a physician may conduct a telemedicine-based exam to qualify a patient for Florida’s compassionate use registry (and start the 90 day clock), assuming the physician subsequently conducts an in-person exam prior to ordering medical marijuana.
  • Whether or not a physician may use telemedicine-based exams for follow-up exams or interim consults with patients receiving medical marijuana, in conjunction with in-person exams.
  • Whether or not the Board’s proposed regulation conflicts or complies with the language in the Florida Constitution created by Amendment 2.
  • Whether or not the Board’s proposed regulation conflicts or complies with the forthcoming regulations to be issued by the Department of Health in July (which should be available ahead of the Board’s August hearing).

Some states, like California, do not prohibit telemedicine-based examinations for medical marijuana, while others, like Colorado, require an in-person examination prior to recommending medical marijuana. Even in states that allow telemedicine-based examinations for medical marijuana, providers should keep in mind that the examination for the condition for which medical marijuana is being recommended must be an appropriate medical examination and meet the standard of care

What’s Next?

Anyone may attend the Florida Board of Medicine public hearing and request to be heard, ask a question, or make a statement.  The hearing will occur on August 4, 2017, at 8:00 am, at:

The Hyatt Regency Miami
400 SE 2nd Avenue
Miami, Florida 33131

We will continue to monitor changes to Florida regulations on this issue.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.

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Key Takeaways From FHA’s Health Law Summit

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Foley recently co-hosted the Florida Hospital Association’s (FHA) 2017 Health Law Summit, which brought together more than 40 in-house attorneys and compliance officers from FHA member hospitals to discuss the current state and future direction of the health care industry.

Amid so much economic and political uncertainty, we are diligent about keeping our fingers on the pulse of the macro trends impacting providers operating in the U.S. health system. While we know you’ve been paying close attention to these developments as well, following is a brief recap that encapsulates the key takeaways from event speakers and other health care practitioners in attendance.

Telehealth and Destination Medicine

Florida has rapidly become a hotspot for the burgeoning area of destination medicine, and hospitals must account for the movement, lest they lose valuable revenue and patients to specialty competitors. While current laws and regulations are complex, there are avenues to create compliant offerings, including telehealth and online second opinion programs.

Health Care Privacy and Cybersecurity

Managing relationships with vendors, especially those who handle protected health information, is key. Best practices include conducting due diligence and negotiating appropriate contractual protection.

Labor and Employment Law

Laws affecting the workplace are in a state of flux, but changes are on the horizon under the new administration, which is generally viewed as being pro-employer. Hospital executives are eager to see how the DOL will be steered on issues such as overtime, worker safety and collective bargaining, to name a few.

False Claims Act Investigations and Enforcement

Civil Investigative Demands (CID) served by the government must be treated differently than other kinds of subpoenas or demands, and misperceived responses can have an adverse impact. In-house counsel who receive CIDs must have an escalation plan that addresses potential high-risk or high-likelihood scenarios, including investigations, litigation, settlements, liability, damages, insurance and disclosures.

Update on Stark Law and Anti-Kickback Statute

Government enforcement of such violations is expanding at a rapid rate, particularly in Florida. There were several notable public settlements in the state last year, as well as changes made to 11th Circuit case law, so it’s important for in-house counsel to stay abreast of these developments.

Boards and Hospital Governance and Compliance

The Department of Justice is increasingly holding individual leaders responsible for the stewardship of their hospitals. Educating hospital boards is vital to effective compliance, especially related to financial arrangements and quality of care.

 

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Florida Board of Medicine Hearing on Telemedicine and Medical Marijuana

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The Florida Board of Medicine will hold a public hearing on February 3, 2017 to discuss its proposed amendment to Florida’s telemedicine practice rules.  The proposed amendment, published December 8, 2016, is intended to clarify that physicians may not order medical cannabis or low-THC cannabis via telemedicine.

The amendment would add a new Section (5) to the Standards for Telemedicine Practice under 64B8-9.0141, F.A.C.  If the proposed amendment is finalized, the regulation would state as follows: “(5) Medical cannabis or low-THC cannabis, as defined by s. 381.986, F.S., may not be ordered by means of telemedicine.”

Interested physicians and providers may want to attend the public hearing, both to learn more about the Board’s position on medical marijuana and telemedicine, and to contribute their perspectives to inform the discussion.  Some points of potentially-useful clarification to discuss at the hearing may include, for example:

  • Whether or not a physician may conduct a telemedicine-based exam to qualify a patient for Florida’s compassionate use registry (and start the 90 day clock), assuming the physician subsequently conducts and in-person exam prior to ordering medical marijuana?
  • Whether or not a physician may use telemedicine-based exams for follow-up or interim consults with patients receiving medical marijuana?

Some states, like California, do not prohibit telemedicine-based examinations for medical marijuana, while others, like Colorado, require an in-person examination prior to recommending medical marijuana.  Even in states that allow telemedicine-based examinations for medical marijuana, providers should keep in mind that the examination for the condition for which medical marijuana is being recommended must be an appropriate prior examination and meet the standard of care.

What’s Next?

The Florida Board of Medicine public hearing will occur on February 3, 2017 at 8:00 a.m., at:

The Omni Orlando Resort at Championsgate
1500 Masters Boulevard
Championsgate, Florida 33896

We will continue to monitor the proposed rules for when the final version is published.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.

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