Pennsylvania Department of Health (DOH)

On Fox’s In the Weeds blog, associate Richard Holzworth discussed the influx of patients registering for the Pennsylvania Medical Marijuana Program, and provided an overview of key policy and procedure updates that PA’s healthcare facilities, including hospitals and long-term care providers, should adopt:

Illustration of Rod of Asclepius on marijuana leafDespite Pennsylvania’s medical marijuana industry being in its infancy, more than 17,000 patients have registered for the program, and more than 4,000 already have received their medical marijuana card from the Department of Health. Now that cannabis products have burst onto the scene, hospitals and other residential healthcare facilities are struggling with what to do when patients present medical marijuana cards and attempt to use marijuana in the facilities. Indeed, it is high time for the healthcare providers to update their policies and procedures to address these growing concerns.

Policy Considerations

In developing a medical marijuana policy, it is important for healthcare administrators to remember that medical marijuana, although legal in most states, is still classified by the federal government as a Schedule I Controlled Substance. With medical marijuana laws varying from state to state, hospitals, healthcare associations, and other stakeholders have developed and implemented a wide range of policies addressing the use and possession of medical marijuana products. These policies range from strict, categorical prohibitions to sanctioned self-therapy during hospital admission. Regardless of a healthcare facility’s philosophy (either from a political or medicinal perspective) on medical marijuana, it is important for each institution to develop and implement a comprehensive set of policies and procedures to address the inevitable circumstance of a patient presenting with a medical marijuana ID card or cannabis products in hand.

Due to the large volume of patient registrants to the Commonwealth’s medical marijuana program, PA physicians and their staff may see local healthcare facilities make changes to their policies and procedures with respect to medical marijuana in the coming months.

We invite you to read Richard’s full informative piece and stay tuned for our coverage of further developments.

This piece originally appeared in the February 2018 issue of the Allegheny County Medical Society Bulletin.

Richard L. Holzworth writes:

In April 2016, Gov. Tom Wolf signed into law Pennsylvania’s compassionate medical cannabis legislation (Act 16), effectively legalizing medical marijuana in the Commonwealth. Since that time, the Pennsylvania Department of Health (DOH) has awarded 12 licenses to grow medical marijuana and 27 licenses to operate medical marijuana dispensaries. It is anticipated that the grow operations and dispensaries will be open for business in early 2018. Although the proponents of medical marijuana have enjoyed widespread support (as evidenced by the 29 states that have enacted a medical marijuana law, including six since 2016), those in the industry are left to trust that Pennsylvania physicians will register with the DOH and send patients to the dispensaries. In other words, now that the legal medical marijuana system is in place, the onus is on physicians to ensure that patients have access to treatment.

Patient and physician registration

It is important for medical professionals to understand that they are not permitted to “prescribe” medical cannabis products. Rather, physicians who have met the registration requirements of Act 16 are permitted to issue “certifications” to patients who qualify for medical marijuana treatment.

In order for a patient to qualify for medical marijuana treatment, the patient must obtain a certification from a registered physician stating that the patient suffers from one of the 17 “serious medical conditions” identified in Act 16. These conditions include:

  • Amyotrophic Lateral Sclerosis;
  • Autism;
  • Cancer;
  • Crohn’s Disease;
  • Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity;
  • Epilepsy;
  • Glaucoma;
  • HIV/AIDS;
  • Huntington’s Disease;
  • Inflammatory Bowel Disease;
  • Intractable Seizures;
  • Multiple Sclerosis;
  • Neuropathies;
  • Parkinson’s Disease;
  • Post-Traumatic Stress Disorder;
  • Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective; and
  • Sickle Cell Anemia.

Once a patient obtains a certification, then the patient must apply for a medical marijuana ID card through DOH. If the application is accepted, the patient (or a qualified, registered caregiver) may take the medical marijuana ID card to a state-licensed dispensary to obtain marijuana products.

In order for physicians to issue medical marijuana “certifications,” they must register with the DOH and complete a four-hour training course offered by DOH-approved providers. The DOH training course covers the following areas:

  • Summary of Act 16;
  • General information about medical marijuana under state and federal law;
  • Scientific research on medical marijuana;
  • Recommendations for medical marijuana, including pain management, risk management, palliative care, misuse of opioids and medical marijuana, and informed consent.

Physicians also are required to be licensed to practice medicine in Pennsylvania and be qualified, by training or experience, to treat at least one of the 17 serious medical conditions.

Once registered, the DOH will place the physician’s name, business address and medical credentials on the physician medical marijuana registry. The registry does not include contact information (telephone numbers or email addresses).

Importantly, registered physicians are not permitted to advertise that they are credentialed to certify patients for medical marijuana use. The DOH regulations have not provided much guidance in the way of what constitutes “advertising” or what is actually permitted, including whether physicians may list medical cannabis certification on their “menu” of services.

Continue Reading A Physician’s Guide to Navigating Medical Marijuana Registration

As previously reported on our Physician Law Blog (see our post here), the Pennsylvania Department of Health issued draft “temporary” regulations regarding physician registration and certification of medical marijuana on April 11, 2017.   Following a brief comment period, the Department finalized its “temporary” regulations in the June 3, 2017 issue of the PA Bulletin.  A copy of the final regulations can be viewed here.

Medical marijuana in jar lying on prescription form
Copyright: megaflopp / 123RF Stock Photo

The regulations are labeled “temporary” because they were adopted to implement PA’s new Medical Marijuana Program.  As a result, they will expire in two years, unless made permanent by the Department.  However, for the first year of the Program, these regulations will govern the registration of any physician who wishes to certify the use of medical marijuana for his or her patients.  The Department has confirmed in a related press release that the Medical Marijuana Program continues to be on schedule for full implementation in early 2018.

The final physician regulations make a few notable changes to the draft regulations, but also leave physicians with some lingering questions regarding the registration process, advertising their certification services, and charging fees for re-certifying the use of medical marijuana for existing patients.

Notable Changes

1.    The publicly available Practitioner Registry maintained by the Department will include only the practitioner’s name, business address and medical credentials (as opposed to the practitioner’s phone number and/or email address).  [See 28 Pa. Code 1181.25].  As a result, a prospective patient seeking a physician on the Practitioner Registry will need to take the extra step to conduct a web search on the physician in order to locate the physician’s contact information.  While this may encourage physicians registered to certify the use of medical marijuana to ensure that their practice websites clearly advertise their services, physicians should note that the Medical Marijuana Act and these regulations prohibit a physician registered to certify the use of medical marijuana from advertising the physician’s marijuana certification services.  It is unclear to what extent this prohibition will permit practice websites to note that one or more of the practice’s physicians are registered to certify the use of medical marijuana.

2.    A physician’s certification for the patient’s use of medical marijuana will now be required to include a statement as to the length of time (which cannot exceed 1 year) for which the practitioner believes the use of medical marijuana by the patient would be therapeutic and palliative.  [See 28 Pa. Code 1181.27(a)(6)].  The certification will also be required to include the recommendations, requirements or limitations as to the form or dosage of medical marijuana appropriate for the patient or a recommendation that the patient speak only with a medical professional employed by, and working at, the dispensary regarding the appropriate form and dosage of medical marijuana.  [See 28 Pa. Code 1181.27(a)(7)].

3.    Under the final regulations, physicians may not receive or provide medical marijuana product samples, and may not serve as a designated caregiver for a patient for whom the physician has issued a certification for medical marijuana. [See 28 Pa. Code 1181.31].

4.    Under the Act, physicians will be required to complete a 4-hour training course on various aspects of the use of medical marijuana in the treatment of serious medical conditions, in order to qualify for registration.  The Department confirmed in these final regulations that it will maintain on its website a list of approved training providers offering the 4-hour course for reference by physicians seeking registration.  [See 28 Pa. Code 1181.32].

Remaining Questions

As first raised in our prior blog post on the Department’s draft temporary physician regulations, the Act and the draft regulations appeared to leave two key questions unanswered.  First, will the physician registration process be electronic or require paper application?  And second, can a physician accept payment from existing patients for re-certifying the use of medical marijuana for those patients?

The Department failed to answer those questions in the final physician regulations. Regarding the former, we will eventually find out how the Department will operate the registration process when it announces the opening of physician registration.  However, regarding the latter, which arises out of the unclear drafting of the Act and these regulations, an answer may require further inquiry with the Department.

I also note that, as raised above, it is unclear whether registered physicians will be able to list on their websites that they are registered to certify the use of medical marijuana.

Stay tuned to the Fox Rothschild Physician Law Blog for updates on physician registration for certification of the use of medical marijuana in Pennsylvania.

Should you have any questions regarding the registration process or what obligations a registered physician will have under the Act, please contact an experienced healthcare lawyer.

As first posted on our sister blog, “In The Weeds” (Fox Rothschild’s Cannabis Law Blog), the Pennsylvania Department of Health issued its long-awaited proposed temporary regulations regarding physicians on April 11, 2017.  A copy of the temporary regulations can be found here:  PA Temporary Physician Medical Marijuana Regulations

The temporary regulations provide additional detail on the physician registration process, including the required four-hour training session regarding the legal use of medical marijuana and research on its effects, as well as the process for patient certification for use of medical marijuana.

The temporary regulations also propose to maintain (without further modification) the following four existing statutory restrictions on physicians:

  • Physicians may not accept, solicit or offer any form of remuneration from or to any individual or medical marijuana organization (such as a grower/processor or dispensary) to certify a patient’s use of medical marijuana;
  • Physicians may not hold a direct or economic interest in a medical marijuana organization in Pennsylvania;
  • Physicians may not advertise their services as a physician who is registered to certify a patient to receive medical marijuana; and
  • A physician may not issue a certification for the physician’s own use of medical marijuana or for the use of medical marijuana by a family or household member.

[28 Pa. Code 1181.31].

Notably, the temporary regulations do not provide further clarity on certain statutory provisions, such as (i) whether the physician registration process will be electronic or require paper application, and (ii) whether a physician may accept payment from existing patients for consultation regarding certification for the use of medical marijuana after the initial certification is issued.

The Department of Health accepted comments on the proposed temporary regulations until April 20, 2017.  It is unclear when the Department plans to issue its final regulations on physicians and medical marijuana.

Stay tuned to the Fox Rothschild Physician Law Blog for updates.