Department of Public Health

The President’s Podium: The Business of Medical Marijuana

Posted in Board of Medicine, Department of Public Health, Health Policy, Medical Marijuana, Public Health on November 7th, 2013 by MMS Communications – 3 Comments

By Ronald Dunlap, M.D., President, Massachusetts Medical Society

It’s been one year since Massachusetts voters approved a ballot question DSC_0003 Dunlap 4x6 color 300 ppi_editedlegalizing the use of medical marijuana, adding the Commonwealth to a growing list of states allowing it to be used as “medicine.”

MMS had vigorously opposed the referendum, on the basis that the drug lacks the rigorous testing as other FDA-approved drugs; that claims for its effectiveness are not scientifically proven; that it poses health risks of toxins and cognitive impairment; and that a physician’s recommendation of any drug should be a medical decision made in the patient’s best interest based on scientific and clinical evidence and not by public vote. Voter approval notwithstanding, we still hold those positions.

Following the vote, the MMS House of Delegates adopted a revised policy, stating our desire to work with the Board of Registration in Medicine (BRM) and the Department of Public Health (DPH) in developing regulations that would address key issues of a medical marijuana program in the state. Among these issues were patient diagnosis, physician certification, implications for occupational safety and health, inclusion in the Prescription Monitoring Program, and adherence to established professional tenets of proper patient care.

That effort proved fruitful. When DPH issued its regulations, our reaction was positive, saying DPH had done a “thoughtful and responsible job overall” and that the regulations “have taken into account many of our concerns, especially those that call for physician judgment in determining what conditions may qualify and the inclusion of the Prescription Monitoring Program in certifying patients.”

We are now, however, seeing a troublesome sign: the emphasis on medical marijuana has turned from patient care to business opportunity. And it goes beyond the investment or ownership opportunities related to dispensaries.

Entrepreneurs and physicians alike have established internet companies offering to match patients with doctors who will certify their need for medical marijuana. These companies will provide consultations and certifications – for fees ranging from a low of around $50 to upwards of $200. “Renewal fees” may also be charged.

I have publicly raised concerns about such sites.  I told The Boston Globe in September such activity is “working around the edges” of the rules, and I elaborated with the Business Journal of Western Massachusetts in October, saying “people that I call internet opportunists are essentially getting a doctor or list of doctors they feel will certify patients, and simply inviting patients to pay them money as a finder’s fee.”

One of the key regulations, sanctioned by the BRM and adopted by DPH at the urging of MMS, was that a physician should have a “pre-existing and ongoing relationship with the patient as a treating physician” before a patient should receive certification.

The proliferation of what I call these “certification centers” is disturbing; it erodes, if not skirts entirely, the “ongoing relationship” regulation and has the potential for abuse.

The experience in Colorado, which approved medical marijuana in 2000, is instructive. A June 2013 report from the Colorado Office of the State Auditor found “evidence suggesting that some physicians may be making inappropriate recommendations.” Twelve physicians had certified half of the 108,000 registered patients, and one had registered more than 8,400.

Despite its legality, many unknowns remain about medical marijuana, including appropriate dosage and frequency of use for conditions, strength of the drug from various sources, and clinical effectiveness. The Massachusetts model does not include any provisions for dosage, administration, or other basic elements that would be contained in a prescription for another medication.

Further, we are uncertain of the liability issues and whether insurers will cover defense costs and judgments in cases involving certifications. The drug also remains prohibited by the federal government, raising more questions about physician licensing by the Drug Enforcement Administration, which, contrary to press reports, has firmly stated that it has not relaxed its policy on medical marijuana.

Each physician, after weighing the risks and reviewing a number of considerations, will make his or her own decision about certifying patients and whether it’s in the best interests of both patient and physician. Some are already doing so.  That is another of the many decisions to be made within the physician-patient relationship.

That the business of medical marijuana has taken hold is no surprise; it was inevitable and likely will always be there. But, as physicians, let’s do what we can to refocus the issue back where it belongs: on patient care and patient safety.

The President’s Podium appears regularly on the MMS Blog, offering Dr. Dunlap’s commentary on a range of issues in health and medicine.

DPH Proposes New Regulations for Prescription Monitoring Program

Posted in Department of Public Health, Drug Abuse, Regulation on February 15th, 2013 by MMS – 8 Comments

Rules May Apply to All Physicians and Prescribers

The Department of Public Health this week presented draft regulations to the Public Health Council to implement changes to the state Prescription Drug Monitoring Program (PMP).

The draft regulations spell out the requirements for review of 12 months of prescribing history in the PMP database by all fully licensed physicians and other professionals for new patients and those who have not been seen in the past 12 months. This requirement appears to be proposed for any patient encounter, regardless of the likelihood of prescribing being indicated.

While there are some exceptions to the requirement listed and more possible in future guidelines, the MMS had hoped the proposed regulations would be more reflective of the demands of clinical practice than the initial draft has proven.

The MMS has engaged the DPH in discussions around the proposed regulations and on recent changes to the drug control registration program done without regulations or public comment and which require submission of email addresses and certification of compliance with the PMP requirements as a condition of receiving a state registration.

The MMS recognizes that limitations of the state database system and federal grant requirements for adherence to specific patient privacy protections have probably had an impact on the DPH in its decisions.

Physicians who cannot meet the new requirements are urged to contact the Department for a waiver of the email requirement. MMS government relations staff is interested in your experiences if you have been subject to a registration recall in 2013. We are also interested in your experiences with the PMP database .

A meeting with DPH staff on the proposed regulations and MMS’s concerns with changes to the drug registration process is scheduled for early March. The MMS continues to investigate options in responding to these initiatives.

There will be a public hearing on the regulations March 22. A final vote is likely at the April Public Health Council meeting.

Physicians are urged to review the proposed regulations and the DPH vision for the PMP program. Future MMS communications will provide more details.

– William Ryder, Esq.