Commissioner Monica Bharel, MD, MPH

January 5, 2017

Commissioner Monica Bharel, MD, MPH

Massachusetts Department of Public Health

250 Washington Street

Boston, MA 02108

Dear Commissioner Bharel:

On behalf of the Massachusetts Senior Care Association (MSCA), which represents approximately 400 nursing homes, we thank the Department of Public Health (Department) for the opportunity to present testimony and comments in response to the Department’s proposed amendments to the following regulation: 105 CMR 725.000: Implementation of An Act for the Humanitarian Medical Use of Marijuana regulations.

Mass Senior Care has identified a number of issues of concern to the nursing home provider community, including: (1) the conflict that exists for providers and employees with federal law that considers the use of marijuana (for medical and/or recreational use) illegal; 2) the lack of operational guidance and/or clarification from the Department for the use of medical marijuana in long term care facilities; and 3) the potential cost implications/administrative burden for long term care facilities to register as Caregiving Institutions and register employees as Institutional Caregivers.

Conflict with Federal Law:

Despite the passage of the Massachusetts Medical Marijuana Law, marijuana remains classified as a Schedule 1 drug under the Federal Controlled Substances Act (CSA). Controlled Substances generally as well as their prescription by physicians, are regulated by the Drug Enforcement

Administration (DEA), under the CSA.[1] As a Schedule 1 controlled substance under the CSA, it means that marijuana has a “high potential for patient abuse, there is no currently accepted medical use in treatment in the United States, and there is a lack of accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug under medical supervision.”[2] Schedule 1 substances may not be prescribed by physicians under federal law.[3]

Since marijuana is still considered illegal under federal law, it raises specific federal liability issues for long term care facilities and their staff who may be individually registered to provide services to a Medicare beneficiary.

Medicare certified institutional providers are required to file an annual cost report (CMS Form 2540). The cost report includes a broad certification that requires an officer of the long term care facility to certify that he or she is “familiar with the laws and regulations regarding the provision of the health care services, and that the services identified in this cost report were provided in compliance with such laws and regulations.” These requirements are also tied to a healthcare facility’s state licensure requirements as the DPH licensure regulations cite compliance with applicable federal law and regulations pertaining to the specific facility type. Therefore, permitting or dispensing of an illegal drug under federal rules could be read to be a violation of “laws and regulations regarding the provision of health care services.” Mass Senior Care is concerned that if a long term care facility permits or participates in the medical use of marijuana through an institutional caregiver on its premises, then state law will have allowed a provider to be in violation of the federal provisions which could jeopardize a long term care facility’s participation in the federal Medicare and Medicaid program.

DPH, as the state surveyor for CMS, would also create a problem for itself as the Department would be required to enforce federal requirements while also allowing a conflicting state regulation.

In addition, facility staff may be hesitant to take on the role of an Institutional Caregiver as they could be subject to the same federal liability issues as long term care facilities.

Lack of Operational Guidance and/or Clarification:

The proposed revisions do not provide operational guidance and/or clarification to long term care facilities for the use of medical marijuana in their facilities. Although the proposed revisions do include requirements on maintaining records on all marijuana received by the institution on behalf of a registered qualifying patient and the administration of such marijuana to the registered qualifying patient, they do not however contain guidance related to acquisition, storage, inventory control, administration, dosage and form of marijuana, observation, disposal of unused marijuana, etc.

Mass Senior Care recommends the Department investigate regulations and guidelines on the use of medical marijuana in long term care facilities in the other 28 states that currently allow its use for the purpose of providing guidance.

For example, in the state of Maine, nursing facilities may voluntarily participate in the Medical Marijuana Program. For those that do participate, Rules Governing the Maine Medical Use of the Marijuana Program, Section 11 Inpatient Hospice and Nursing Facilities regulations specifically provides operational guidance including acquisition, storage, inventory control, assisting in the administration of marijuana, confidentiality, dosage and use documentation, observation, discharge of a resident, disposal of unused marijuana and protected conduct for nursing facilities and staff.

Potential Cost Implications/Administrative Burden for Long Term Care Facilities to Register as Caregiving Institutions and Register Employees as Institutional Caregivers:

In the presentation provided to the Public Health Council on September 14, 2016, the rationale for creating separate categories of caregivers and their employing institutions was to address the operational realities of facilitating the medical use of marijuana in an institutional setting and in a manner more akin to the administration of prescription medication for residents. Since prescription medications are only allowed to be administered by nurses in long term care facilities, Mass Senior Care is requesting clarification from the Department that nurses are the only staff that may administer and/or assist in the administration of medical marijuana in long term care facilities.

Mass Senior Care also requests clarification from the Department on the following questions related to 725.021: Registration of Caregiving Institution and 725.022 Registration of Institutional Caregivers:

1)  Does the certificate of registration as a caregiving institution require renewal on an annual basis or is it a permanent certificate of registration?

2)  Is the certificate of registration as a caregiving institution transferable upon change of ownership?

3)  Is it a one-time fee for registering as a Caregiving Institution?

4)  Is the registration fee for Institutional Caregivers per facility or per individual filed on the application?

5)  Since the registration card for an institutional caregiver is valid for only one year from the date of issue, and must be renewed annually, would there be a fee for subsequent annual renewal?

Mass Senior Care is concerned about the burden that will be placed on long term care facilities regarding 725.024 (C) which states “A caregiving institution must notify the Department no more than one business day after an institutional caregiver ceases to be associated with the caregiving institution.” There is a relatively high turnover of licenses nurses in nursing facilities. Based on a 2016 survey conducted by Mass Senior Care, only 70% of nursing staff (RN, LPN) are still employed at a long term care facility after one year. To reduce the unnecessary administrative burden on long term care facilities, Mass Senior Care recommends revising the proposed regulation to be similar to the State of Maine where the facility is the “designated” caregiver. Maine’s regulation still requires the facility to register individuals but requires the facility to keep staff registration cards locked in a secure location and no staff member can remove his or her card from the facility. Mass Senior Care recommends a bi-annual reconciliation of the registered staff and return of the staff registrations for those staff members no longer employed at the facility.

MSCA welcomes the opportunity to work with the Department in amending regulations to ensure access to high quality long term care and to protect the rights of both patients and providers.

Sincerely,

Tara M. Gregorio

President

800 South Street, Suite 280, Waltham, MA 02453 Tel: 617.558.0202 Fax: 617.558.3546 www.maseniorcare.org

[1] See U.S.C. §§ 801-971.

[2] 21 U.S.C. § 812(b)(1).

[3] 21 U.S.C. §§ 801-812; Pearson v. McCaffrey, 139 F. Supp. 2d 113, 121 (D.D.C. April 19, 2001).