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DOH Issues Temporary Regulations for Patients and Caregivers

September 28, 2017

By: Elizabeth M. Hein

On September 25, 2017, the Pennsylvania Department of Health (“DOH”) continued its efforts toward full implementation of the Pennsylvania Medical Marijuana Program, issuing temporary regulations for patients and caregivers, even as growers and processors have sued the agency over its permit approvals potentially putting the program’s progress at risk.1 See 28 Pa. Code Ch. § 1191.21 et seq. To date, DOH has finalized temporary regulations for Growers and Processors, Dispensaries, Laboratories, Physicians and Practitioners, and Safe Harbor Letters.2 The regulations for patients and caregivers set forth the requirements for consumers of medical marijuana to lawfully obtain the product. DOH will accept comments on the temporary regulations through October 2, 2017, and will publish a finalized form of the temporary regulations in the Pennsylvania Bulletin.

General Requirements for Medical Marijuana Identification Cardholder Applications

Patients - or their caregivers3 - seeking to lawfully obtain medical marijuana must apply to DOH for an identification card.  The application fee is $50, but the fee can be waived for those who demonstrate hardship.4 The application in support of an identification card must include:

  • The name, address, phone number, email address, if available, and date of birth of the patient;
  • The patient’s PA driver’s license number or other Department of Transportation state-issued identification card, if applicable;
  • The name, address, and phone number of the practitioner treating the patient;
  • Documentation from the practitioner that all of the requirements of 35 P.S. § 10231.403(a) (relating to the conditions for issuing a patient certification) have been met;5
  • The patient certification issued by the patient’s practitioner;
  • The name, birth date, address, phone number, and email address, if applicable, of up to two caregivers designated by the patient or the patient’s parent, legal guardian, or spouse;
  • The appropriate fee or proof of financial hardship;
  • The signature of the applicant and date signed;
  • A statement that a false statement made in the application is punishable under 18 Pa. C.S. Ch. 49 (relating to falsification); and
  • Any other information deemed necessary by DOH.6
  • If the application is submitted by the caregiver, the application must include the name, phone number, email address, date of birth, and driver’s license number or Department of Transportation state-issued identification card, if applicable, of the caregiver, and a copy of a criminal background check.7

DOH will review the criminal background check and review the Prescription Drug Monitoring Program (PDMP) database before approving an identification card application filed by a caregiver.8 DOH may deny an identification card application submitted by a caregiver if the caregiver has been convicted of a criminal offense that occurred within the past five years relating to the sale or possession of drugs, narcotics, or controlled substances.9 The regulations do not contain an equivalent requirement of a criminal background check for medical marijuana identification card applications submitted directly by patients.

Denials (and approvals) by the Department of a medical marijuana identification card are considered “adjudications” under the Pennsylvania administrative procedure laws and may be appealed.10

Responsibilities of Cardholder

A medical marijuana cardholder may only obtain medical marijuana from a dispensary holding a DOH-issued permit based on a recommendation in a patient certification that is signed by a practitioner, submitted to and approved by DOH, and accessed by a dispensary through the dispensary’s electronic tracking system. Medical marijuana cardholders cannot possess a different type of medical marijuana product from that indicated on the patient certification, greater than a 30-day supply, or medical marijuana that has not been dispensed by a dispensary.11

A medical marijuana cardholder must immediately contact DOH upon any of the following: (1) change of the cardholder’s name or address; (2) withdrawal of a patient certification by a practitioner; (3) written notification from DOH that the patient’s practitioner has been removed from the practitioner registry; (4) a decision by a patient or legal guardian to discontinue the services of a caregiver; (5) a decision by a caregiver to no longer serve as a caregiver for the patient; or (6) a decision by a patient or legal guardian to obtain medical treatment from another practitioner.12 Failure to contact DOH as required may result in the cardholder being unable to use the identification card at a dispensary.13

Patient and Caregiver Registry

DOH will maintain a confidential list of patients and caregivers to whom it has issued identification cards.14 Importantly, information maintained by DOH related to medical marijuana cardholders is not subject to public disclosure under the Right-to-Know Law (65 P.S. §§ 67.101-67.3104), including information provided in an identification card application, information contained in a patient certification issued by a practitioner, criminal background check information provided as part of an identification card application, information encoded in the 2-D barcode of an identification card, and information relating to a patient’s serious medical condition.15

DOH may revoke or suspend a patient or caregiver’s identification card and remove the patient or caregiver from the patient and caregiver registry under certain circumstances, including if DOH receives notification that the cardholder has been convicted of a criminal offense related to the sale of drugs, narcotics, or controlled substances, or has intentionally, knowingly or recklessly violated any provision of the Medical Marijuana Act, 35 P.S. § 10231.101 et seq., or implementing regulations.16 

Expiration and Renewal

Identification cards expire one year from the date of issuance, or earlier if the patient certification is for a period of less than a year, or if the patient dies.17 Identification cards can be renewed following procedures set forth by DOH. 

Conclusion

The regulations for patients and caregivers are fairly straightforward. Practitioners and institutional health care providers may benefit from reviewing and understanding them because a patient or caregiver’s failure to obtain a medical marijuana identification card will be an obstacle to the patient accessing potentially therapeutic care. Physicians who regularly treat patients with “serious medical conditions” should seek further education and training regarding the risks and benefits of medical marijuana, as well as legal guidance to minimize exposure to malpractice liability and other violations of law.

 

Disclaimer: This post does not offer specific legal advice, nor does it create an attorney-client relationship. You should not reach any legal conclusions based on the information contained in this post without first seeking the advice of counsel.

About the Author:

Elizabeth Hein

Elizabeth M. Hein is an Associate in Post & Schell’s Regulated Cannabis and Health Care Practice Groups and Chair of the Healthcare Subcommittee of the Philadelphia Bar Association Hemp and Medical Marijuana Committee. She provides legal services to the Firm’s health care clients in litigation, regulatory and compliance matters.  Ms. Hein’s litigation practice includes assisting in the defense of complex commercial, regulatory and antitrust matters, medical staff litigation, and injunctive proceedings. Her healthcare consulting services include federal and state regulatory compliance, fraud-and-abuse and False Claims Act analysis and consultation, and not-for-profit governance, licensing and accreditation. Learn More >

 

Footnotes:


1 One lawsuit seeks an injunction against DOH requiring it to rescind all awarded permits and start over from scratch.  See “Suit to halt Pa. marijuana program may cause ‘pain, agony, & death’” (September 11, 2017), http://www.philly.com/philly/business/cannabis/suit-to-halt-pa-marijuana-program-may-cause-pain-agony-death-20170911.html (last visited September 26, 2017). 

2 See 28 Pa. Code §§ 1131-1181.  All regulations issued to date are “temporary” and will expire two years following the publication of the temporary regulation.  The Medical Marijuana Advisory Board is responsible for reviewing the regulations and issuing a final written report containing recommendations regarding the regulations and other aspects of the Medical Marijuana Program.  See 35 P.S. § 10231.1107; § 10231.1201(j)(f).

3 Caregivers are appointed for minor patients, and can be a parent, legal guardian or spouse, an individual designated by a parent, legal guardian, or spouse, or an appropriate individual approved by DOH upon a sufficient showing that no parent or legal guardian is appropriate or available.  A practitioner may also recommend that a caregiver by designated for an adult patient.  28 Pa. Code § 1191.22(e)-(f).  An individual can be approved to serve as a caregiver for up to five patients.  28 Pa. Code § 1191.27(d)(7). 

4 28 Pa. Code § 1191.31(a), (d). 

5 In order for a practitioner to issue a certification to use medical marijuana, the following conditions must be met:  (1) the practitioner must have been approved by DOH for inclusion in the physician registry, and have a valid, unexpired, unrevoked, unsuspended Pennsylvania license to practice medicine; (2) the practitioner must have determined that the patient has a serious medical condition and included the condition in the patient’s health care record; (3) the patient is under the practitioner’s continuing care for the serious medical condition, and (4) in the practitioner’s professional opinion and review of past treatments, the practitioner determines the patient is likely to receive therapeutic or palliative benefit from the use of medical marijuana.  35 P.S. § 10231.403(a). 

6 28 Pa. Code § 1191.27(b)(1)-(10). 

7 See 28 Pa. Code 1191.27(d). If the application is submitted by a “third-party caregiver” (i.e., a caregiver who is not a parent, guardian, or spouse), the application must include an authorization to designate a third-party caregiver form, which will be prescribed by the Department.  28 Pa. Code § 1191.27(e). 

8 28 Pa. Code § 1191.27(f). 

9 28 Pa. Code § 1191.29(c). 

10 28 Pa. Code § 1191.33.

11 28 Pa. Code § 1191.23(a)-(c). 

12 28 Pa. Code § 1191.24(a)(1)-(6). 

13 28 Pa. Code § 1191.24(b). 

14 35 P.S. § 10231.302(a).

15 28 Pa. Code § 1191.25(b). 

16 28 Pa. Code § 1191.26(a)(1)-(6). 

17 28 pa. Code § 1191.30(d).