PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Proposed Action:
Amendment of section 80.138 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 3309
Finding of necessity for emergency rule:
Preservation of public health.
Specific reasons underlying the finding of necessity:
The regulatory revisions are necessary for emergency implementation to safeguard the lives and well-being of New Yorkers who are otherwise at increasing risk for opioid-associated harm including death.
In New York State substantial mortality is associated with opioids. In 2012, there were 875 deaths where the toxicology reports indicated opioid analgesics. In addition, 478 overdose deaths occurred that year associated with heroin and 150 deaths for which the toxicology report indicated an unspecified opioid. The heroin-related deaths for 2012 represent an almost-threefold increase from two years earlier. Although there are not yet consolidated reports for more recent years, there is reason to believe, based on information shared by local jurisdictions as well as from legislative hearings, that this trend has not only continued, but has grown at an alarming rate.
Similarly, costly hospitalizations in which opioids have been identified among the diagnostic codes have risen substantially. In 2012, there were more than 75,000 hospital discharges in which opioids were identified. This is an increase of approximately 4,000 from four years earlier. Although a broad range of opioid-related diagnoses is represented in these figures, they indicate the growing problem associated with this class of drugs.
There is a broad-based interest in—and commitment to—resolving New York State’s opioid crisis. Part of that response includes providing law enforcement and firefighting personnel with the training and the naloxone necessary to save lives when they are the first to arrive on the scene of a suspected overdose. The Division of Criminal Justice Services, working with the Department of Health, Albany Medical Center, the Harm Reduction Coalition, local health departments and other community partners has initiated training of law enforcement officers, with a goal of 5,000 trained in the first year. There have been immediate benefits from these trainings, including overdose reversals successfully carried out within hours of a training. This initiative is currently severely hampered in its implementation by a requirement that each officer have his or her own rescue kit and that the officer cannot share it with colleagues. The revised regulation will address that. The revised regulation allowing for non-patient specific prescriptions of naloxone—something now authorized under the law—will eliminate the de facto requirement that prescribers be physically present every time that naloxone is furnished or dispensed. This will provide immediate relief not only in training public safety personnel, but also for more community-oriented programs, in which prescriber availability is extremely limited.
Subject:
Opioid Overdose Programs.
Purpose:
Modification of the rule consistent with new statutory language and with the emergency nature of opioid overdose response.
Substance of emergency/proposed rule (Full text is posted at the following State website:www.health.ny.gov):
The regulatory changes accomplish the following:
• authorize clinical directors and affiliated prescribers to prescribe an opioid antagonist to trained overdose responders, and for those prescriptions to be either patient-specific or non-patient-specific;
• require clinical directors to designate those individuals by name or by description who will be furnishing or dispensing naloxone pursuant to a non-patient specific prescription;
• allow for trained overdose responders to have shared access to, and use of, an opioid antagonist so long as the following conditions are met: they are trained in accordance with the regulations; they have a common organizational or workforce bond; and there are policies and procedures in place within that organization or workforce that ensure orderly, controlled access to an opioid antagonist by an identifiable pool of trained overdose responders;
• expand the organizations which may have regulated opioid overdose prevention programs to include the following: public safety agencies, state agencies and pharmacies;
• add a reporting requirement, so that the department will know on a quarterly basis how many overdose responders each program trains as well as how many doses of naloxone each program furnishes;
• require public safety and firefighting personnel to have their overdose reversals reported directly to the department by their agencies;
• require the maintenance and provision of masks or other similar barriers only for those programs which incorporate rescue breathing in their curriculum;
• acknowledge the curriculum approved by the Division of Criminal Justice Services as acceptable for trained overdose responders who are public safety personnel, and acknowledge that a comparable curriculum approved by the Department of Health may be used for firefighters;
• require that registered programs maintain and furnish instructional material to participants, including how to recognize symptoms of an opioid overdose; the steps to be taken in responding to an opioid overdose; and how to access the Office of Alcoholism and Substance Abuse Services (OASAS) through both a toll-free number and its website;
• require that documentation be furnished at the time naloxone is dispensed pursuant to a non-patient specific prescription that indicates the following: that naloxone has been furnished pursuant to a non-patient specific prescription; the name of the prescriber; the opioid antagonist being prescribed; the date of the furnishing or dispensing; and the name of the person receiving the opioid antagonist; and
• acknowledge that prescribers unaffiliated with registered programs may issue patient-specific prescriptions for an opioid antagonist to individuals in their care at risk of an opioid overdose.
This notice is intended:
to serve as both a notice of emergency adoption and a notice of proposed rule making. The emergency rule will expire May 6, 2015.
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
Statutory Authority:
Chapter 413 of the Laws of 2005, effective April 1, 2006, added Section 3309 of the Public Health Law to provide for opioid overdose prevention programs in New York State (NYS). Pursuant to PHL Section 3309(1), as amended by Chapters 34 and 42 of the Laws of 2014, the Commissioner of Health is authorized to establish standards for approval of opioid overdose prevention programs.
Legislative Objectives:
This legislation was enacted in order to reduce the incidence of fatal opioid overdoses by making possible the timely, appropriate and safe administration of life-saving medication on an emergency basis to individuals who experience opioid drug overdoses. To achieve this objective, the revised regulations address the issuance of non-patient specific prescriptions for an opioid antagonist, something that is permitted for the first time under the 2014 revisions to PHL Section 3309. The regulations also authorize a practice implicit in the statute: the shared access to—and use of—an opioid antagonist by trained overdose responders. To further address the law’s objective of reducing the incidence of fatal overdoses, the regulations support a broader range of qualified organizations in becoming registered opioid overdose prevention programs by including public safety agencies, state agencies and pharmacies as eligible organizations. The law and the regulations also mandate that the furnishing or dispensing of naloxone be accompanied by information on recognizing the symptoms of an opioid overdose, on what steps to take in the course of an overdose, on how to access the HOPE Line maintained by the Office of Alcoholism and Substance Abuse Services (OASAS); and on how to access the OASAS website.
Needs and Benefits:
Overdose is a preventable cause of death in the majority of cases involving opioids. Opioids include heroin as well as prescribed analgesics such as morphine, codeine, methadone, oxycodone (Oxycontin, Percodan, Percocet) and hydrocodone (Vicodin). In an opioid overdose, the user becomes sedated and gradually loses the urge to breathe, leading to death from respiratory depression. Naloxone is an opioid receptor antagonist that can be used to reverse an opioid overdose, generally within 1-2 minutes of administration. An untreated opioid overdose may result in death over the course of 1-3 hours. Approximately half of all injection drug users (IDUs) experience at least one nonfatal overdose during their lifetime.
According to the Centers for Disease Control and Prevention (CDC) drug overdose deaths are now the leading cause of accidental death in the United States for people aged 25-64, Of the 22,134 deaths relating to prescription drug overdose nationally in 2010, 16,651 (75%) involved opioid analgesics (also called opioid pain relievers or prescription painkillers). In 2011, drug misuse and abuse caused about 2.5 million emergency department (ED) visits. Of these, more than 1.4 million ED visits were related to pharmaceuticals.
In New York State, substantial mortality is associated with opioids. In 2012, there were 875 deaths where the toxicology reports indicated opioid analgesics. In addition, 478 overdose deaths occurred that year associated with heroin and 150 deaths for which the toxicology report indicated an unspecified opioid.
In 2013, there were 115,000 admissions to OASAS-certified treatment programs where heroin or other opioids was the primary, secondary, or tertiary substance of abuse. This was an increase of 23% from 88,000 such admissions in 2004.
Most overdoses are not instantaneous and the majority of them are witnessed by others. Therefore, many overdose fatalities are preventable. Prevention measures include education on risk factors (such as polydrug use and recent abstinence), recognition of the overdose and an appropriate response. Response includes contacting emergency medical services (EMS) and providing resuscitation while awaiting the arrival of EMS. Resuscitation may also include the administration of naloxone which immediately reverses the effects of an opioid overdose. Naloxone is an opioid antagonist with no abuse potential and no effect on a recipient who has not taken opioids. Provision of naloxone has been recommended for many years and is being offered in a variety of settings in a growing number of jurisdictions throughout the United States. Complications of naloxone in the medical setting are rare.
Opioid overdose prevention programs, including those regulated by the current regulation, have proven effective in preventing unnecessary deaths. As of June 30, 2014, more than 140 programs have registered as Overdose Prevention Providers and more than 75,000 naloxone kits have been distributed by NYSDOH. As of that same date, there were 918 reports of overdose reversals with the naloxone kits. Seventy-one percent of the people who received naloxone because of a drug overdose were between the ages of 18-45; the vast majority had injected heroin; and frequently opioids were used in combination with alcohol and other drugs. The largest number of reversals have been reported from New York (Manhattan) (208, 22.7%), Erie (175, 19.1%) and Bronx (157, 17.1%) counties.
The amendment to the rule achieves the following: 1) health care providers are authorized to issue patient specific and non-patient specific prescriptions for naloxone; 2) in instances when regulated programs will be using non-patient specific prescriptions for naloxone, the clinical director must delegate those individuals who will be carrying out the dispensing; 3) shared access to—and use of—naloxone among trained overdose responders is now permitted so long as: a) these responders are trained in accordance with the regulations; b) there is a common organizational or workforce bond among them; and c) there are policies and procedures in place within that organization or workforce that ensure orderly, controlled access to an opioid antagonist by an identifiable pool of trained overdose responders; 4) provider eligibility has been expanded to include public safety agencies, state government agencies and pharmacies; 5) registered programs will now be required to report on a quarterly basis the number of doses provided to trained overdose responders and the number of responders trained; and 6) all naloxone distribution is to be accompanied by information on how to recognize an opioid overdose, how to respond to an opioid overdose; and how to access OASAS, both through its HOPE Line as well as through its website.
These changes under the proposed regulations will result in improved distribution of naloxone in the community and result in reduced incidence of fatal opioid overdoses. The reporting requirement will give the state an improved understanding of the impact of this program. Expanded access to naloxone does not lead to increased drug use. Naloxone is not addictive and does not cause a “high.” It has no potential for abuse, nor does it have a street value associated with diversion.
Costs:
There are no new mandates. This regulation continues to allow, not require, creation of opioid overdose prevention programs. Costs for the implementation and ongoing operations of regulated programs to those parties that elect to establish them will continue to be minimal. As was past practice, no registration fee is being collected. A one-time application process remains in effect in order for an opioid overdose prevention program to receive a certificate of approval. Existing staff can serve as the regulated program’s Program Director. Internal operational policies and procedures, as well as the training of staff, remain as requirements. Reporting requirements are minimal and consistent with Public Health Law.
The state has appropriated and is making funding available for the following activities. The NYSDOH estimates that approximately 48,000 individuals will become trained overdose responders between April 1, 2014 and March 31, 2015 at an estimated annual cost of $3,000,000 for the kits. Training costs will be covered with existing resources within the Department of Health budget. The amount for subsequent years will decrease considerably, in part because of the accrued benefit of train-the-trainer sessions. The estimated annual cost in the years subsequent to the 2014-2015 State Fiscal Year is likely to range between $1,000,000 and $2,000,000. All of these costs are borne with State funding. There is no local funding used for this initiative.
Local Government Mandates:
For purposes of implementing amendments to Section 3309 of the Public Health Law, local government agencies will be made aware of the option to voluntarily offer opioid overdose prevention programs, though in no case is participation in this program mandated. Local EMS will continue to receive information concerning opioid overdose prevention.
Paperwork:
The NYSDOH anticipates a continued simple and streamlined process for eligible organizations to obtain a certificate of approval to establish an opioid overdose prevention program. The record keeping and reporting requirements imposed on the programs are minimal. Only those providers voluntarily participating will be required to provide information to the department.
Duplication:
The proposed amendments to the regulation do not duplicate any existing state or federal law or regulation regarding opioid overdose prevention.
Alternatives:
The proposed amendments to the regulation do not exceed the specific requirements of the legislation. Because offering an opioid overdose prevention program is voluntary, the regulation was designed to encourage eligible individuals and organizations to provide opioid overdose prevention services allowed under law and regulation. The approval process continues to be simple; and the reporting and financial impact of establishing a voluntary opioid overdose prevention program remains minimal. Any other alternatives would require a more complex and more costly approach for both the NYSDOH and volunteer operators of opioid overdose prevention programs.
Federal Standards:
The rule does not exceed any minimum standards of the federal government for the same or similar subject areas.
Compliance Schedule:
Each individual or organization that chooses to establish an opioid overdose prevention program must submit an initial application to the department. Information on approved programs is then used to develop a listing of opioid overdose prevention programs, which is shared with the public. Applications for approval to establish opioid overdose prevention programs will continue to be accepted on an ongoing basis, with review and renewal happening at two-year intervals.
Regulatory Flexibility Analysis
Effect of Rule:
The proposed rule will have minimal impact on small businesses and local governments. The principal goal of the regulatory changes is to ensure improved access to naloxone in the community by allowing non-patient specific prescriptions of naloxone and shared access to—and use of—naloxone by trained overdose responders under specified conditions. The proposed rule also allows for the following additional eligible providers to maintain regulated overdose programs: public safety agencies, state agencies and pharmacies. None of those entities would be required to maintain an overdose prevention program; rather they may voluntarily choose to have such a program. The minimal impact on small businesses and local governments is underscored by the modest nature of opioid overdose prevention programs; no fee is required for approval, ongoing technical assistance is provided at no cost by the Department of Health to these programs, and recordkeeping and reporting are minimal.
Compliance Requirements:
Under the proposed rule, eligible providers that elect to establish opioid overdose prevention programs will continue to report overdose reversal on forms provided by the NYSDOH. There is an additional requirement mandating that the regulated programs report to the department on a quarterly basis the number of doses of naloxone provided to trained overdose responders as well as the number of responders trained. Record keeping mandated of programs is minimal.
Offering of opioid overdose prevention programs remains entirely voluntary.
Professional Services:
No additional professional services will be required since providers and others will be able to utilize existing staff or can utilize the services of others with whom they have a relationship.
Compliance Costs:
There are no additional costs associated with non-patient specific prescriptions for naloxone nor for the shared access to—and use of—naloxone. In fact, the shared access to naloxone may reduce the burden on organizations whose staff are being trained in opioid overdose.
The additional organizations under the revised regulations that are eligible to operate opioid overdose prevention programs and that seek NYSDOH approval to establish these programs will be provided with application guidelines and technical assistance. The additional organizations are public safety agencies, state agencies and pharmacies. Reporting requirements pertaining to opioid overdose prevention programs will be minimal for those providers that voluntarily elect to establish such opioid overdose prevention programs. The estimated cost of reporting is, at most, $150 per year.
Economic and Technological Feasibility:
Most health care practitioners and organizations that are, or would be, eligible to offer opioid overdose prevention programs have the capacity and expertise to carry out the necessary activities. Small businesses that opt to voluntarily offer opioid overdose prevention programs will be provided with necessary forms and instructions to comply with the approval process and reporting requirements. In large part, these forms and instructions are developed with specific input from regulated parties and NYSDOH resources are being made available to provide instructions and technical assistance.
Minimizing Adverse Impact:
There are no alternatives to the proposed recordkeeping and reporting requirements. NYSDOH has a responsibility to ensure that approved opioid overdose prevention programs conduct activities in a manner that maximizes the impact of this program. It also has a responsibility to collect information consistent with the reports to the Governor and the Legislature that are mandated in Section 3309(5) of the Public Health Law.
Small Business and Local Government Participation:
Small businesses (including small business hospitals, clinics, health care practitioners, drug treatment programs, individual practitioners, and community-based organizations) as well as local health departments had an opportunity to review and comment on the original regulations as well as on subsequent proposed changes. A similar opportunity is being provided with respect to the changes in the regulations now being proposed, particularly with non-patient specific prescriptions for naloxone and shared access to—and use of—naloxone by trained overdose responders. The department has already begun to have conversations with public safety agencies and some registered programs regarding these issues. There will also be discussions with pharmacies and state agencies that are now eligible to maintain registered programs.
Rural Area Flexibility Analysis
Types and Estimated Number of Rural Areas:
Rural areas are defined as counties with a population less than 200,000 and, for counties with a population greater than 200,000, include towns with population densities of 150 persons or less per square mile. There are 43 counties in NYS with a population less than 200,000. Eleven counties have certain townships with population densities of 150 persons or less per square mile. The proposed rule will have minimal impact on practitioners, organizations, local governments and pharmacies in these rural areas.
The additional organizations under the revised regulations that are eligible to operate opioid overdose prevention programs are public safety agencies, state government and pharmacies. In rural areas, those entities most likely to be represented among new registrants are public safety agencies and pharmacies. Registration as an opioid overdose prevention program is entirely voluntary. Potential providers are most likely to be located in urban or suburban, not rural, areas.
Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services:
Under the proposed regulations, reporting, record keeping and other compliance requirements applicable to providers that seek department approval to offer opioid overdose prevention programs are minimal. There is a new reporting requirement that registered programs on a quarterly basis inform the department of the number of doses of naloxone provided to trained overdose responders as well as the number of responders trained. These data are essential for the department to be compliant with mandated reports to the Governor and the Legislature.
Costs:
The department, either directly or under contract, will provide technical and other assistance to organizations and practitioners implementing opioid overdose prevention programs.
Minimizing Adverse Impact:
The program is designed to minimize impact on those who will participate in the following ways: participation is voluntary; the registration process is simple; no fees are charged; and record-keeping and reporting requirements are minimal.
Rural Area Participation:
The department has actively sought to engender increased opportunities for opioid overdose prevention, including in rural parts of the state. That has entailed one-on-one dialog with—and technical assistance provided to—eligible providers in the state’s rural counties. That focus will not change with the amended regulation; however there will be increased opportunities for implementation of the regulated programs in rural areas because new classes of organizations will be eligible: public safety agencies, state agencies and pharmacies.
The mechanisms for engaging rural participation include outreach by department staff, as well as from local health departments and from staff from the Office of Alcoholism and Substance Abuse Services, the Division of Criminal Justice Services, the Harm Reduction Coalition, Albany Medical College and other community partners.
The NYSDOH, since the implementation of the current regulations, has considered input on how they could be improved. The most significant changes in the proposed regulation—including non-patient specific prescriptions; shared access to, and use of, naloxone by trained overdose responders; and expanded eligibility were the product of this input.
Job Impact Statement
A Job Impact Statement is not required. The proposed rule will not have a substantial adverse impact on jobs and employment opportunities based upon its nature, purpose and subject matter.
