The Department of Health (DOH) received the following comments, which are summarized below with responses:

COMMENT: Many comments from practitioners, pharmacists and professional organizations were supportive of DOH’s Prescription Monitoring Program Registry (PMP).

COMMENT: Several comments were received from the pharmacy community related to the 24-hour controlled substance reporting requirement. Requests were made to change the 24-hour reporting requirement to “within one business day”. Operational details related to this requirement were also requested.

RESPONSE: Representatives of DOH met with pharmacy associations, representing both chain pharmacies and independent pharmacies, to assess the feasibility of 24-hour controlled substance reporting to the PMP. DOH representatives were assured that a 24-hour reporting period was feasible. In addition, the 24-hour reporting period was also suggested by the workgroup established by the Internet System for Tracking Over-Prescribing Act (I-STOP), Chapter 447 of the Laws of 2012. Operational requirements have been posted on the DOH, Bureau of Narcotic Enforcement’s web site.

COMMENT: Several comments were received related to the zero controlled substance reporting requirements for pharmacies. A commenter stated that this requirement required a change in software and requested an expanded time frame (six months) for implementation of the zero reporting requirement.

RESPONSE: The zero reporting requirement utilizes the same reporting requirements currently in existence for the reporting of controlled substance data in NYS. DOH acknowledges that minimal changes in software may be necessary. This is not expected to impact the majority of pharmacies in NYS.

COMMENT: Comments were received related to the submission of dispensing data based on the date the prescription was delivered. Multiple comments suggested that this is a new standard. Commenters requested that DOH allow for the option to report to the PMP from “either…the date filled or from the point of sale” with an indication of which date was used or to change the requirement all together to the date filled.

RESPONSE: There was no change in the regulation related to the submission of data based on the date the controlled substance was delivered. The current regulation does not provide for information to be submitted based on date filled, and the change proposed in these regulations is only related to the time frame (i.e., 24 hours) in which reporting must occur. The definition of “deliver” in regard to controlled substances may be found in Article 33 of the Public Health Law, Section 3302.

COMMENT: Comments were received regarding the time frame for the submission of corrections of pharmacy data submissions.

RESPONSE: Time frames related to error correction reporting were not addressed in this regulation.

COMMENT: Comments were received related to unattended or automated reporting of pharmacy controlled substance data and requests were made to “have an unattended reporting tool for an automatic uploading of data to enable them to submit their daily information to the PMP.”

RESPONSE: Unattended reporting of pharmacy controlled substance data was not addressed in this regulation, and there is nothing in statute or regulation prohibiting it. Although it is not available yet, DOH is actively working on this tool for pharmacy data submissions.

COMMENT: Comments were received inquiring about access to the PMP by a health care plan pharmacist and whether or not a physician employed by a health care plan could access the PMP information and delegate the information to others.

RESPONSE: The proposed regulations only relate to each of these questions within the context of a customer presenting a valid prescription to a pharmacist or a patient being treated by a physician.

COMMENT: A comment was received requesting “state specific penalties for practitioners or pharmacists whose practices access a person’s information when not done in the course of patient care.”

RESPONSE: These regulations did not establish any new penalties. However, there are multiple statutes that provide penalties for willful violations of the NYS Public Health Law.

COMMENT: A number of comments were received that explained certain types of practices and scenarios that the commenters believed warranted specific exceptions to the duty to consult or report to the PMP, and one suggested that self-monitoring would be sufficient if practitioners were given access to the PMP. A comment was received asking why, in a pharmacy setting, access to the PMP as a designee is limited to pharmacists and pharmacy interns. A number of comments included fact-specific information regarding why consultation of the PMP or reporting (or zero reporting) to the PMP would be difficult, costly, or create negative unintended consequences and requesting that an exception be made or waiver granted.

RESPONSE: The issue that all of the types of comments have in common is that they are based on objections to requirements in I-STOP. While these requirements are included in the proposed regulations as well, they are statutory requirements that cannot be undone by regulation. Specific exceptions were included in I-STOP, and it must be presumed that the Legislature intended to provide exceptions only in those instances and that any group or scenario that was not specifically exempted by the Legislature in I-STOP was intended to comply with the statute and subsequent regulations. In the instances where specific facts regarding individual offices, companies or practices were provided, the commenters may wish to request a waiver in compliance with the I-STOP regulations upon adoption of such regulations.

COMMENT: One comment was received requesting access to the PMP by out-of-state pharmacists filling prescriptions that were written in New York.

RESPONSE: That issue is not mandated in I-STOP and was not addressed in the proposed regulations.

COMMENT: A number of comments have requested grace periods for certain groups or in general and/or a delay in implementation of the proposed regulations. One comment, in particular, noted that the possibility of the proposed regulations becoming effective so close to the implementation date results in a “very narrow timeline [that] does not provide adequate time to develop and implement policies and procedures at the institution that will be sufficient to meet the requirements outlined in the final regulations.”

RESPONSE: I-STOP does not provide for a grace period or any delay in implementation.

COMMENT: One comment asserted that the current PMP does not allow providers to identify designees, and that there will be a wait time of approximately two to three weeks after implementation before this becomes possible.

RESPONSE: This comment addresses concerns about implementation rather than concerns or suggestions regarding the proposed regulations. However, it should be noted that this assertion is inaccurate, and providers have been able to identify designees since July 8, 2013. There will be no wait time regarding the identification of designees on the PMP for providers who have the necessary Health Commerce System (HCS) account.

COMMENT: Additionally, one comment stated that when I-STOP is effective, many prescribers may not yet have obtained the required HCS account or have “obtained approval for designated support staff to facilitate the duty to consult the [PMP].”

RESPONSE: Practitioners have been authorized to access the PMP through an HCS account since February of 2010, and the upcoming duty to consult the PMP was specified in I-STOP, which was signed into law on August 27, 2012. The proposed regulations were not the initiator of a practitioner’s need to access to the HCS system. Additionally, the only “approval” that is necessary to designate support staff is that of the practitioner, who exhibits his/her approval by signing into his/her HCS account, accessing the PMP, and adding the support staff member as a designee – no additional approval is required in I-STOP or the proposed regulations.

COMMENT: Comments were submitted requesting exceptions from the requirement to document in a patient’s chart whether or not the PMP was consulted and, if not, the specific exception that would authorize the decision not to consult the PMP. The exceptions were being sought for instances such as where opioids are administered to inpatients, asserting that this requirement would be burdensome, or when an exception would regularly apply such as physicians in emergency departments.

RESPONSE: I-STOP and the proposed regulations provide multiple exceptions to the duty to consult the PMP. The I-STOP workgroup recommended that practitioners document whether or not they have consulted the PMP and, if they have not consulted, the specific exception relied on by the practitioner in choosing not to consult the PMP. That recommendation was incorporated into the proposed regulation. This documentation could be as simple as a checkbox in the patient’s chart – especially in instances where the exception is regularly utilized. This provision will serve to protect practitioners who will, undoubtedly, have instances where they will have to answer questions about their treatment of specific patients. Rather than having to rely on memory or reconstruct their thought process at a given time, practitioners will have documentation regarding their consultation of – or reason to not consult – the PMP.

COMMENT: A comment was submitted requesting “clarification permitting hospital-employed practitioners/prescribers to utilize hospital administrative personnel who work with their practices as designees.”

RESPONSE: This issue is addressed in the proposed § 80.63(c)(3)(ii), specifying that a practitioner may appoint a designee if “the designee is employed by the same professional practice or is under contract with such practice. For purposes of this subparagraph, professional practice shall include, but not be limited to, an institutional dispenser where the designating practitioner is employed, under contract, or otherwise has privileges or authorization to practice”. Therefore, a practitioner who is not within the same practice, in the traditional sense, as a hospital’s administrative personnel may still be authorized to designate such personnel to access the PMP on his/her behalf.

COMMENT: A number of commenters presented questions or suggestions specific to implementation. For example, questions about how to utilize the system, where and how often information must be uploaded and electronic prescribing (which is not the subject of these regulations). Also, comments were received suggesting that DOH continue to alert pharmacies of missing or incorrect data and allow them to send in corrections within a reasonable timeframe, as well as providing written guidance to hospice program directors.

RESPONSE: This is not the proper forum to address these implementation issues, and the commenters are encouraged to contact the Bureau of Narcotic Enforcement directly with any questions or concerns regarding implementation and the PMP system. Additionally, DOH will consider all suggestions that have been submitted whether or not they apply to the proposed regulations.

COMMENT: Comments were received requesting that practitioners be allowed to use PMP data obtained more than 24 hours before a prescription is issued. Citing practitioner’s workflow, these requests included a 36-hour time frame or at the time of admission for a prescription issued to inpatients upon discharge.

RESPONSE: The 24-hour window allows practitioners or their designees to obtain a patient’s history outside of patient hours, yet ensures the data is still timely. This timeframe was recommended by the I-STOP workgroup.

COMMENT: Multiple comments were received asking that residents be allowed direct access to the PMP rather than accessing it as designees of a practitioner.

RESPONSE: The definition of “practitioner” within Article 33 does not include unlicensed residents, therefore precluding them from having direct access to the PMP. Unlicensed residents may access PMP information as a designee, receive it from a supervising physician or colleague or from administrative staff, providing teaching institutions with multiple options for disseminating this information. Residents who are licensed through the State Education Department may independently access the PMP. Moreover, the proposed regulations are also consistent with the supervised and limited practice of medicine engaged in by residents.

COMMENT: Comments were received concerning a practitioner’s responsibility when she/he cannot access the PMP due to various technological failures.

RESPONSE: These concerns were addressed in the proposed regulations. Proposed section 80.63(2)(ix) would exclude practitioners from the duty to consult the registry on an occasion “when [the] registry is not operational…or where it cannot be accessed by the practitioner due to a temporary technological or electrical failure.”