|August 12, 2014|
Previously published on August 6, 2014
If voters pass Amendment 2 in November, the use of marijuana will be permitted for certain medical purposes. As a result, the Florida legislature and regulatory agencies will be charged with developing statutes and regulations that create a new type of health care provider and that alter the practice of medicine as we know it. Because Florida Amendment 2, unlike the Colorado law, is only seeking to authorize marijuana for medical use, its passage will create yet another regulated “health care” provider in an already highly regulated Florida health care industry.
Even before voters have the opportunity to decide whether to vote on Amendment 2, the use of a non-euphoric strain of medical marijuana (Charlotte’s Web) has already been legalized in Florida. But the law has such restrictive terms (e.g., it can only be ordered for individuals with cancer or seizure disorders and only 5 nurseries can produce it that have been in operation for 30 continuous years) which is not likely to have a meaningful effect on health care as Amendment 2.
The concept of medical marijuana has created a lot of media attention and has even spawned the creation of new legal focus groups. But it is just another day for lawyers who regularly advise in the health care industry. Health lawyers are constantly studying new health laws and are advising clients how to structure their business plans to comply with these laws. If Amendment 2 passes, health lawyers will also use their industry knowledge to advise on the interplay between the medical marijuana law and other health laws and regulations.
Board certified health lawyer Erin Aebel and attorney Rachel Goodman, both at Shumaker, Loop & Kendrick, LLP in Tampa, have identified at least 5 important health law issues for potential medical marijuana providers to consider if Amendment 2 becomes law.
1. Insurance requirements.
Since insurers are not likely to cover medical marijuana, at least initially, it will be a cash business. But what about those patients who are Medicare or Medicaid beneficiaries or who receive private insurance coverage? Regulations govern the steps providers must take before they can charge a Medicare or Medicaid beneficiary cash for medical services. Also, many private insurance companies require physicians under contract with them to notify a patient in advance and in writing before they charge a health plan member for a non-covered item.
2. Privacy laws and patient rights.
A patient receiving medical marijuana treatment may want to limit access to health information concerning their treatment. If HIPAA applies to a marijuana treatment provider, a patient will have the right to restrict some access to that information. For example, under HIPAA, a patient who pays cash for a health care service may have the right to restrict the release of that treatment information to their health plan.
3. How does a physician certification differ from a prescription?
If Amendment 2 passes, medical marijuana will become legal under Florida law, but it still will not be approved by federal law. Prescription drugs are regulated on the federal level by the Food and Drug Administration and the Drug Enforcement Agency. Because medical marijuana is not federally approved, the proposed Florida law allows for “physician certifications” instead of prescriptions. What is unclear at this point is what standard of care the physician must meet prior to issuing a certification and whether this is different from the various Florida and federal laws regulating a physician’s prescribing practice. Regulations may be issued that clarify the standards.
4. Standard or alternative medicine?
If medical marijuana is approved and regulated in Florida, will it be considered standard medicine or an alternative therapy? Florida law already requires that physicians provide certain patient disclosures and record keeping when providing alternative therapies.
5. How will existing fraud and abuse laws apply to the relationships between certifying physicians and marijuana treatment centers?
A number of criminal and civil laws restrict or carefully regulate a physician’s ability to profit off of the physician’s referral of a patient for a health care item or service. How will that affect the relationship between the certifying physician and the marijuana treatment center? Must the certifying physicians be independent of the treatment centers or can they be employed by them or have another type of financial relationship with the center?
No one will know for sure how all of these issues and the many other regulatory health care issues raised by medical marijuana will be resolved unless and until Amendment 2 passes and Florida legislature and the regulatory agencies develop statutes and regulations.