The final regulations for the Massachusetts medical
marijuana law became effective May 24, 2013. The regulations cover the
activities of physicians, patient eligibility, and rules for the ownership and
operation of medical marijuana dispensaries.
This commentary is provided for informational purposes only.
Readers are strongly encouraged to read the
full text of the regulations (.pdf, 52 pages).
A detailed MMS overview of the physician-related sections is available here.
Federal Law and the
Massachusetts Statute
The MMS thoroughly researched the legal implications of the
new law and how it will work in the context of federal laws and regulations. The
relevant opinion was issued in 2002 by a federal appeals court in the case of Conant v. Walters. That decision protected
a physician’s first amendment right to discuss medical marijuana with their
patients, but it does not create a right for physicians to help patients obtain
cannabis for medical use.
The Role of
Physicians
The narrow federal protection cited above is the reason that
the new Massachusetts law sets up a structure which limits the role of
physicians to providing the DPH with a written certification of potential
patient benefit from marijuana. This will allow a patient to obtain a state
issued registration card and obtain marijuana from a dispensary. This system means
that the physician is not writing a prescription or directly referring a
patient to a source of marijuana, and is consistent with Conant v. Walters. These remain federally prohibited. However, the
Obama administration has indicated that it will not pursue legal action in any
state in which medical marijuana has been legalized.
Requirements for
Physicians
- Certifying physicians must have a full active
license, with at least one established place of business in Massachusetts
- Starting on or after Jan. 1, 2014, physicians
must complete two hours of CME credits on the proper use of medical marijuana
before being permitted to issue certifications
- Physicians must utilize the state Prescription
Monitoring Program before certifying a patient
- Certifications must be submitted after a
clinical visit
- Certifications are valid for no fewer than 15
days and no more than one year
- No certifying physician, physician co-worker or
family member may have a financial relationship with a marijuana dispensary
- Physician may not certify marijuana use for
themselves
- Physicians may not delegate certification to any
other person, or any other health care professional
- A physician’s certification privileges may be
revoked for failure to comply with the regulations.
Bona Fide
Physician-Patient Relationship
The new state law requires a bona fide physician-patient
relationship prior to writing a certification for a patient. Certifying
physicians should document a full assessment of the patient’s medical history
and current medical condition, explain the potential benefits and risks of
marijuana use, and have a role in the ongoing care and treatment of the
patient.
Debilitating Medical
Condition
The law specifies certain diseases but allows certification
for other debilitating conditions as determined by the patient’s physician. The
regulations require that a patient must not only have one of the diseases
included in the referendum but also must suffer debilitating symptoms. The
regulations provide broad physician discretion allowed in the certification
process which, in other states, has led to abuses and threaten the integrity of
the entire process.
Minors
The adopted regulations expanded the draft regulations regarding
access to marijuana by minors during the last six months of life. The final
rules allow the override of the “life-limiting” provision and by changing the
definition of “life-limiting illness” from six months to two years. The
scientific evidence is clear that marijuana use by children is dangerous, as
studies have found toxic effects on the still-developing brains of young
people.
Dual Oversight
Specifically in the law there is a statement that physicians
are not required to participate in certifying patients. Physicians concerned
about accusations of discrimination from advocates for not participating in the
program should be assured by the specific protection for non-participating
physicians in the law, as well as in the general standard of care for
physicians which requires them not to participate in clinical evaluations and
treatments which are beyond or inconsistent with their skills, knowledge and
training.
The Board of Registration in Medicine has clear authority
for conduct in disciplining physicians for unprofessional behavior, but the
Department of Public Health (DPH) has also reserved for itself the right to require
certifying physicians to register with the Department and to revoke such
registrations if physicians commit fraud in certifying patients or submit
certifications without having engaged in the required CME programs.
While disciplinary processes and implications for the Board
of Medicine are well established, the mechanism by which the DPH would conduct
such a process is unclear, as are the implications for physicians regarding the
national practitioner databank, physician licensing here and in other states
and credentialing for participation in insurance and public payment systems
should the DPH revoke a registration. The DPH does not plan to charge physicians
for registering as certifiers.
Supply
The law sets a sixty day supply for a patient a ten ounces.
There is no clinical evidence supporting this level of consumption and some
addiction medicine sources would find serious abuse in a recreational user
consuming an ounce in a month. One
option is for physicians to certify patients for a lesser period. For example,
a 15 day certification would allow one time dispensing of no more than 2.5
ounces.
In contrast, a patient certified for a full year would,
without limitation, be allowed up to ten ounces every 60 days for a total
annual purchase of 3.75 pounds of marijuana. Certifications for short periods
would not protect patients for possession of marijuana charges after the period
expires.
Physicians may specify more than 10 ounces to be dispensed
but may not specify less through any measure other than the time limits. Given
the significant cost per ounce and the effects of consumption, legitimate
patients are unlikely to take full advantage of their option to buy ten ounces
for personal use.
Liability Coverage
Issues
Physicians interested in certifying an
individual patient should carefully review the liability coverage and policies
of the group, facility or setting in which they practice.
Physicians practicing in sites which specialize in marijuana
assessments should carefully review the regulations and their professional
liability policies, to ensure they are practicing within the law and within
their liability coverage which is required as a condition of practice. Practices
that are exclusively certification sites may be operating inconsistently with
the regulations, particularly in the area of the physician-patient relationship.
Prescription
Monitoring Program Requirements
The regulations require use of the state’s Prescription Monitoring
Program prior to issuing a patient certification. The program (or a similar
database), which holds data on all schedule II-V prescriptions, will record on
marijuana certifications and dispensing. It is unclear how such data may be
used, but it should provide physicians with documentation of patient’s
prescription histories. For example, the data could document the patient’s
efforts at pain management which may support the use of marijuana, or it could provide
histories that suggest potential problems for patients.
Confidentiality of Information
Physicians must discuss with patients the extensive
information on diagnosis and dispensing that will be held by the DPH. The DPH’s
intention is to keep patient specific information confidential and will not
share such information with dispensaries.
However, physicians should note that their participation in
the certifying process is not confidential.
Registered Marijuana
Dispensaries
The Public Health Council amended the regulations to refer
to “registered marijuana dispensaries” as the name used to describe the
statutorily created medical marijuana treatment centers. The Council felt that
neither treatment nor medical care was provided at these sites. This is an
important distinction.
Physicians must remember that in certifying a patient as
having a disease from which they might benefit from the use of marijuana,
physicians are enabling a patient to go to a facility of their choice where the
patient will likely receive marijuana, and possibly advice, from individuals who
are not required to have a clinical background.
Additionally, dispensaries should receive no information
directly from physicians on a patient’s medical history. This is completely
different from other referrals in the medical world and the implications are
not clear yet. Physicians are barred from participating in dispensing marijuana
for their patients whom they certify. The DPH will develop educational
materials for patients in dispensaries.
