The Massachusetts Medical Society strongly supports the prescription monitoring program and was instrumental in its establishment in 1992. We also support modernization of the program to allow improvements in clinical care and reductions in the prevalence and profound impact of drug abuse and addiction on our Commonwealth. The MMS strongly supports changes which are already underway to allow prescribers to efficiently gain access to up to date information through enrollment in the program.
The MMS is concerned that over the years since their creation the Prescription Monitoring Program Advisory Council and the Prescription Monitoring Program Medical Review Group have been underutilized and marginalized. The proposed regulations complete this process formally, to the detriment of the public. In Section 700.012 (B) the proposed regulations remove all requirements for there to be an advisory council by substituting "may" for "shall". An identical substitution in 700.012 of may for shall eliminates requirements for the existence of the medical review group.
In Section 700.012 (D), the proposed regulations appear to reduce patient privacy protections by substituting "kept confidential" for "not be disseminated". This is of particular concern since the database now includes sensitive information on mental health treatment prescriptions. Additionally the proposed regulations mandate that the Department shall notify appropriate law enforcement, regulatory and licensing agencies if there is a reasonable cause to believe a violation of law or violation of professional standards may have occurred. This language reflects recent statutory changes which require such actions. However, outreach to non-treatment personnel has always been authorized in regulations through the Medical Review Group (MRG). The regulations should solidify and enhance the role of the MRG as the determiner of whether "reasonable cause to believe a violation" has occurred. The proposed regulations leave intact prior language with an advisory role for the MRG. Since the MRG does not have to exist, as noted above, it isn't clear that this important role in privacy protection will be continued or effective. The MMS is concerned that important procedures for dissemination of patient specific information should be more clearly delineated and formalized. The MRG's role should be expanded with clear membership with set terms and representatives of organizations such as the Massachusetts Medical Society, the Massachusetts Pharmacists Association and other groups representing providers and patients.
The MMS is concerned that the language in section (F) appears to allow direct online access to the confidential database at the discretion of the Commissioner or his designee, without any MRG role. In subsection (F) (2) the authorization extends to personnel listed in subsection (D) (2) (a)-(c).
M.G.L. Chapter 94C Section 24 A reads in part:
"The department shall, upon request, provide data from the prescription monitoring program to the following:-
(1) persons authorized to prescribe or dispense controlled substances, for the purpose of providing medical or pharmaceutical care for their patients;
(2) individuals who request their own prescription monitoring information in accordance with procedures established under chapter 66A;
(3) persons authorized to act on behalf of state boards and regulatory agencies that supervise or regulate a profession that may prescribe controlled substances; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation;
(4) local, state and federal law enforcement or prosecutorial officials working with the executive office of public safety engaged in the administration, investigation or enforcement of the laws governing prescription drugs; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation;
(5) personnel of the executive office of health and human services regarding Medicaid program recipients; provided, however that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation; or
(6) personnel of the United States attorney, office of the attorney general or a district attorney; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug related investigation.
(g) The department may, at its initiative, provide data from the prescription monitoring program to practitioners in accordance with section 24.
This statutory language is well balanced in that it allows investigators engaged in legitimate ongoing investigations to request information about specific subjects of those investigations and requires the DPH to provide such information. The distinctions in the wording of this statutory language between the access of health care providers and all others make it clear that access to the raw data and the database by investigatory personnel listed in the statute is not allowed. The regulations appear to require and authorize such direct access.
The MMS recognizes that requiring the DPH to provide timely assistance to investigations will require the dedication of resources. However, the program is funded by significant fees on health care providers. These fees should be entirely dedicated to the program, thereby providing adequate staffing. The Department could seek funding from investigatory agencies or the legislature to improve its staffing if inadequate to meet demands. The MMS strongly believes that direct access to deeply personal clinical information by individuals not providing or facilitating care of patients is a complete violation of patient confidentiality inconsistent with the standards of patient privacy we have come to expect from this Commonwealth.
One more point on this issue; the statute allows direct access to practitioners, at the Department's discretion. The MMS strongly supports such access. However, as noted above, the statute clearly envisions direct access to the database by practitioners and a much lesser right to request individual specific information be provided by the DPH to law enforcement but no direct access. The regulations do the opposite by giving direct access to any "person" acting on behalf of an investigatory agency but not any person acting on behalf of a prescriber. Medical assistants and other staff are covered by HIPPA; their efficient and regulated access to the information on behalf of prescribers will greatly facilitate use of the program without threatening patient confidentiality.
The MMS strongly supports the DPH in its efforts to make the PMP effective and efficient. We look forward to improved access to information for clinicians and to responsible cooperation between the DPH and enforcement agencies in a way that balances patient privacy protections with the need for effective means to address the abuse of prescription drugs.
