proposed amendment, that it will not have an adverse impact on jobs and
employment opportunities.
PROPOSED RULE MAKING
NO HEARING(S) SCHEDULED
Prescription Monitoring Program
I.D. No.
HLT-25-13-00017-P
PURSUANT TO THE PROVISIONS OF THE State Administrative Pro-
cedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of Part 80 of Title 10 NYCRR.
Statutory authority:
Public Health Law, sections 3333, 3343-a and 3371
Subject:
Prescription Monitoring Program.
Purpose:
Reporting requirements to the prescription monitoring program
registry by pharmacies and dispensing practitioners.
Substance of proposed rule (Full text is posted at the following State
website: www.health.ny.gov):
Pursuant to recent amendments to Article
33 of the Public Health Law, the proposed regulations set forth the duty of
practitioners to consult the Prescription Monitoring Program Registry
(PMP), the duty of pharmacies to update the PMP in real time, the ability
of pharmacists to consult the PMP, and the ability of practitioners and
pharmacists to appoint designees to access the PMP on their behalf, as
well as exceptions to such duties.
These proposed regulations would require practitioners to consult the
PMP for the purpose of reviewing a patient.s controlled substance history
prior to prescribing for or dispensing to that patient any controlled
substance listed on schedule II, III, or IV. Such history would be required
to be obtained from the PMP no more than 24 hours prior to the practi-
tioner prescribing or dispensing any controlled substance to that patient.
Confirmation of such consultation or the reason for failing to consult
would be noted in the patient.s medical chart by the practitioner.
The amendments include exceptions to the duty to consult:
1. veterinarians;
2. a practitioner dispensing pursuant to Public Health Law section
3351(3);
3. a practitioner administering a controlled substance;
4. a practitioner prescribing or ordering a controlled substance for a
patient of an institutional dispenser for use on the premises of or an emer-
gency transfer from the institutional dispenser;
5. a practitioner prescribing a controlled substance in the emergency
department of a general hospital, provided that the quantity of controlled
substance prescribed does not exceed a five-day supply if the controlled
substance were used in accordance with the directions for use;
6. a practitioner prescribing a controlled substance to a patient under
the care of a hospice;
7. a practitioner when:
a. it is not reasonably possible for the practitioner to access the PMP
in a timely manner;
b. no other practitioner or designee authorized to access the PMP is
reasonably available; and
c. the quantity of controlled substance prescribed does not exceed a
five-day supply if the controlled substance were used in accordance with
the directions for use;
8. a practitioner acting in circumstances under which consultation of
the PMP would result in a patient's inability to obtain a prescription in a
timely manner, thereby adversely impacting the medical condition of such
patient, provided that the quantity of the controlled substance does not
exceed a five-day supply if the controlled substance were used in accor-
dance with the directions for use;
9. a situation where the PMP is not operational or where it cannot be ac-
cessed by the practitioner due to a temporary technological or electrical
failure; or
10. a practitioner to whom the commissioner has granted a waiver from
the requirement to consult the PMP. A waiver could be issued by the com-
missioner based upon a showing by a practitioner that his or her ability to
consult the PMP is unduly burdened by:
a. technological limitations that are not reasonably within the control
of the practitioner; or
b. other exceptional circumstance demonstrated by the practitioner.
These proposed regulations also provide that a practitioner may autho-
rize a designee to consult the PMP on his or her behalf, provided that the
ultimate decision as to whether or not to prescribe or dispense a controlled
substance remains with the practitioner and is reasonably informed by the
relevant controlled substance history information obtained from the PMP.
A practitioner could only appoint a designee if:
1. such designee is located in the state of New York when accessing the
PMP;
2. 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;
3. the practitioner takes reasonable steps to ensure or has actual knowl-
edge that such designee is sufficiently competent in the use of the PMP
and that such designee is aware of and conforms to all relevant federal and
state privacy statutes;
4. the practitioner remains responsible for ensuring that access to the
PMP by the designee is limited to authorized purposes and occurs in a
manner that protects the confidentiality of the information obtained from
the PMP, and remains responsible for any breach of confidentiality; and
5. the practitioner selects and maintains all active designees authorized
to access the PMP.
Upon relinquishment or termination of employment or authorization as
a designee, a designating practitioner would be required to immediately
notify the Department of the revocation of the designee.s authorization to
access the PMP on the designating practitioner.s behalf.
These proposed regulations would also allow a pharmacist to consult
the PMP in order to review the controlled substance history of an individ-
ual for whom one or more prescriptions for controlled substances is pre-
sented to such pharmacist. A pharmacist would also be able to designate
another pharmacist or a pharmacy intern to consult the PMP on the
pharmacist.s behalf, provided that:
1. such designee is located in the state of New York when accessing the
PMP and is employed by the same pharmacy or is under contract with
such pharmacy; and
2. the designating pharmacist selects and maintains all active designees
authorized to access the PMP.
Upon relinquishment or termination of employment or authorization as
a designee, a designating pharmacist would be required to immediately
notify the Department of the revocation of the designee.s authorization to
access the PMP on the designating pharmacist.s behalf.
The amendments would require real-time reporting of prescription
information. Pharmacists and dispensing practitioners within New York
State would be required to file information regarding controlled substances
and the patient with the Department via the Bureau of Narcotic Enforce-
ment within 24 hours of the substance being delivered. A waiver allowing
such filings within a longer period of time could be issued by the commis-
sioner based upon a showing of economic hardship, technological limita-
tions that are not reasonably within the control of the pharmacy or practi-
tioner; or other exceptional circumstance. Pharmacies delivering
prescriptions by mail or licensed express delivery services would be
required to file the prescription information not later than 72 hours after
the substance was shipped from the pharmacy.
These proposed regulations would also require, when applicable,
pharmacies and dispensing practitioners to file a zero report, which is a
report that no controlled substances were dispensed by a pharmacy or
dispensing practitioner during the relevant period of time. A zero report
would be required no later than 14 days following the most recent previ-
ously reported dispensing of a controlled substance, the submission of a
prior zero report, or the termination of a waiver of the requirement to file a
zero report. A waiver of the requirement to file a zero report could be is-
sued by the commissioner based upon a showing that a pharmacy or prac-
titioner does not dispense controlled substances within the state of New
York.
These proposed regulations also provide for the sharing of confidential
patient information with other select entities including the deputy attorney
general for the Medicaid fraud control unit or his or her designee, local
health departments, medical examiners or coroners, and to an individual
(to provide the individual his or her own controlled substance history) and
law enforcement under certain circumstances.
Text of proposed 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.state.ny.us
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:
Section 3308(2) of the Public Health Law authorizes and empowers the
Commissioner to make any regulations necessary to supplement the provi-
sions of Article 33 of the Public Health Law in order to effectuate their
purpose and intent. In addition, regulations with regard to the Prescription
Monitoring Program Registry (PMP) are authorized by Public Health Law
§ 3343-a(9). The Department proposes amendments to the regulations that
would effectuate the changes in § 3333 and § 3371 of the Public Health
NYS Register/June 19, 2013 Rule Making Activities
9
Law and the addition of § 3343-a to the Public Health Law resulting from
Chapter 447 of the Laws of 2012.
Legislative Objectives:
Article 33 of the Public Health Law, officially known as the New York
State Controlled Substances Act, was enacted in 1972 to govern and
control the possession, prescribing, manufacturing, dispensing, administer-
ing and distribution of controlled substances within New York. The
legislative purpose of Article 33 is to allow the legitimate use of con-
trolled substances in health care, including palliative care, veterinary care,
research and other uses authorized by the law while combating the illegal
use of and trade in controlled substances. The proposed amendments are
required by changes to Article 33 of the Public Health Law pursuant to
Chapter 447 of the Laws of 2012.
Needs and Benefits:
These amendments are required to facilitate the changes and the addi-
tions to the Public Health Law enacted by Chapter 447 of the Laws of
2012 which, among other things, require real-time reporting to the PMP
by pharmacies and dispensing practitioners and add a duty to consult the
PMP by practitioners who are prescribing controlled substances.
Benefits of the proposed amendments include ensuring that practitioners
are aware of other prescriptions that their patients have recently received
which could discourage .doctor shopping. and avoid over-prescribing of
controlled substances, as well as assisting in avoiding harmful drug
interactions. The proposed amendments will implement the recent changes
to Article 33 of the Public Health Law made by Chapter 447 of the Laws
of 2012. A more specific description of the benefits provided by the
amendments follows.
The current regulations require prescription information from pharma-
cies and dispensing practitioners for certain controlled substances to be
filed electronically with the New York State Department of Health on a
monthly basis. The amendments specify the new .real time. reporting
requirement added by Chapter 447 of the Laws of 2012 as .24 hours after
the substance was delivered.. The amendments also specify a new report-
ing time frame for mail or licensed express delivery services of .not later
than 72 hours after the substance was shipped from the pharmacy. and a
waiver process to allow pharmacies to make such filings within a longer
period of time. Additionally, the amendments create a requirement for
.zero reporting. when no controlled substances have been dispensed by a
practitioner or pharmacy to ensure that at least every 14 days the Bureau
of Narcotic Enforcement has been informed that no controlled substances
have been dispensed. The amendments provide for a waiver of the zero
reporting requirement when appropriate. Also, the amendments authorize
pharmacists to access the PMP .in order to review the controlled substance
history of an individual for whom one or more prescriptions for controlled
substances is presented to such pharmacist., as well as providing for the
authorization of designees to access the PMP on the pharmacist.s behalf.
New York State has collected controlled substance dispensing informa-
tion since 1973. Since February of 2010, a portion of the data contained
within the PMP has been made available to all DEA-licensed practitioners
throughout New York State, free-of-charge. Although the PMP has been
in existence for decades, practitioners have never been required to consult
it, and very few have used it. From February of 2010 through March of
2013, out of approximately 115,000 practitioners, only about 4,400 had
used the PMP for a total of approximately 407,000 searches. Pursuant to
Chapter 447 of the Laws of 2012, and as specified in the amendments,
practitioners will be required to consult the PMP .[p]rior to prescribing
for or dispensing to a patient any controlled substance listed on schedule
II, III, or IV...for the purpose of reviewing that patient.s controlled
substance history. and to use as a deciding factor regarding .whether or
not to prescribe or dispense a controlled substance [to the patient.]. This
consultation must occur .no more than 24 hours prior to the practitioner
prescribing or dispensing any controlled substance to that patient.. There
are enumerated exceptions, as well as a waiver process from this duty to
consult. There is also a provision for the authorization of designees to ac-
cess the PMP on the practitioner.s behalf.
These proposed amendments promote the safe and effective use of pre-
scription drugs while attempting to curb the diversion of such drugs.
Requiring real-time updates of the PMP and consultation of the PMP by
practitioners has the potential to minimize medication errors and reduce
the possibility of .doctor shopping. and over-prescribing. This should
lead to enhanced patient care and safety.
The use of data from the PMP will help practitioners make a more
informed decision when deciding whether to prescribe a controlled
substance to a patient. Similarly, a review of the PMP will serve to further
inform pharmacists about their patient presenting a prescription for a con-
trolled substance. The use of the PMP will present a clearer picture of a
person.s controlled substance history to the practitioner or pharmacist
before prescribing or dispensing controlled substances in schedules II
through IV. Some members of the medical community and particular
professional societies have expressed concerns with these new
requirements. Some of the expressed concerns have been the impact to
practitioners. work-flow and the expressed belief that practitioners, instead
of checking the database, would choose to not treat a patient who might
otherwise be an appropriate candidate for a controlled substance
prescription. As noted above, these amendments contain exceptions which
address those concerns, detailing circumstances when a waiver is appropri-
ate and restating various patient safety exceptions.
The amendments also provide for the sharing of confidential patient in-
formation with other select entities including, the Deputy Attorney for the
Medicaid Fraud Control Unit or his or her designee, local health depart-
ments, medical examiners or coroners, and to an individual (to provide the
individual his or her own controlled substance history) and law enforce-
ment under certain circumstances.
Costs:
Costs for the Implementation of, and Continuing Compliance with the
Regulation to the Regulated Entity:
Pharmacies and dispensing practitioners may incur costs related to
programming associated with the implementation of the more frequent
reporting requirement of controlled substance data to the Department. As
pharmacies and dispensing practitioners currently are required to report to
the Department on a monthly basis, costs should be limited to initial
programming changes related to the 24-hour reporting requirement. Most
pharmacies are expected to use existing software applications and/or exist-
ing vendors to meet this requirement. A survey of existing chain pharma-
cies and vendors that support independent pharmacies indicated program-
ming costs associated with implementation of the reporting requirement
could be up to approximately $15,000. Other vendors indicated that they
are currently able to meet the requirement with minimal lead time and
costs. Dispensing practitioners that currently utilize the existing online
manual data reporting system will be able to continue to utilize this
Department-supported reporting system with no additional costs
anticipated. There is no fee, tax, or transactional cost associated with creat-
ing a Health Commerce System account or accessing the PMP. In addi-
tion, the amendments include a waiver process to allow pharmacies and
practitioners to report within a longer period of time.
Costs to State and Local Government:
The proposed rule does not require local government to perform any
additional tasks as governmental entities, but will result in additional
administrative tasks by the Department of Health as discussed below.
Therefore, it is not anticipated to have an adverse fiscal impact on local
government, but the Department of Health anticipates increased adminis-
trative costs as discussed below. It should be noted that 95 pharmacies
throughout the State are owned by government entities and costs will be
incurred by those government-owned pharmacies in the same manner as
independent and chain pharmacies. Real-time updates and consultation of
the PMP with regard to controlled substances could reduce the number of
incidents of diversion and will likely reduce the volume and negative
impacts of over-prescribing and the associated costs to the State. Therefore,
the regulations may have a positive fiscal impact in that regard.
Costs to the Department of Health:
The Department of Health staff time will be necessary to implement the
amendments allowing practitioner designees to access the PMP, as well as
pharmacists and their designees. The Department will need to review
Health Commerce System account applications and create user accounts
for these new designees and pharmacists. It is estimated that 40,000
practitioners and an unknown number of designees to approximately
90,000 practitioners will require user account set-up. In addition, while
not mandated, the potential exists for approximately 22,000 pharmacists
and an unknown number of their designees to request user accounts. In ad-
dition, computer program development is needed to implement these new
functionalities, including linking a practitioner.s/pharmacist.s account to
that of a designee. In addition, several computer programmers have been
assigned to update the current data collection system and add additional
functionalities to the PMP, allowing pharmacies to report information in
.real-time. in a more secure and user-friendly fashion.
Local Government Mandates:
The proposed rule does not impose any new programs, services, duties
or responsibilities upon any county, city, town, village, school district, fire
district or other specific district, except where pharmacies are owned by
local governments as described above.
Paperwork:
There is paperwork and process associated with obtaining authorization
to access the PMP. Each practitioner or pharmacist, if they wish to consult,
will be required to obtain a Health Commerce System account, if they do
not currently have one, and if the practitioner or pharmacist chooses to ap-
point designees then that information will have to be entered into the
system by the practitioner or pharmacist. It is anticipated that these activi-
ties will primarily occur initially upon implementation of the amendments.
Duplication:
The requirements of this proposed regulation do not duplicate any other
state or federal requirement.
NYS Register/June 19, 2013
Rule Making Activities
10
Alternatives:
Changing the regulations was required by virtue of amendments to state
statute. There were no significant alternatives to be considered during the
regulatory process.
Federal Standards:
The regulatory amendments do not exceed any minimum standards of
the federal government. There is no federal equivalent to the PMP nor are
there any federal standards regarding state PMPs.
Compliance Schedule:
The proposed rule requires real-time reporting by pharmacies and
consultation of the PMP by practitioners in compliance with Part A of
Chapter 447 of the Laws of 2012 which will be effective August 27, 2013.
Regulatory Flexibility Analysis
Effect of Rule:
This proposed rule will affect New York State practitioners who pre-
scribe and dispense prescriptions for controlled substances and New York
State pharmacies and pharmacists. Records retrieved from the Education
Department.s Office of the Professions show that as of January 7, 2013
there were a total of 115,032 practitioners (physicians, dentists, physician
assistants, podiatrists, midwifes and nurse practitioners) registered in the
State of New York. Records retrieved from the Education Department.s
Board of Pharmacy show that as of January 7, 2013, there were a total of
5,044 registered pharmacies and there were 18,958 registered pharmacists
in the State of New York. Of these totals, approximately 2,573 represent
small business establishments and 95 are owned by government entities,
accounting for 51% and 1.9% respectively of the total number of
pharmacies.
Compliance Requirements:
These amendments are required to facilitate the changes and the addi-
tions to the Public Health Law enacted by Chapter 447 of the Laws of
2012 which, among other things, require real-time reporting to the PMP
by pharmacies and dispensing practitioners and add a duty to consult the
PMP by practitioners who are prescribing controlled substances.
Under current regulations, pharmacies and dispensers are required to
report controlled substance dispensing data to the Department on a
monthly basis. The proposed amendments would require more frequent
reporting of controlled substance dispensing data (i.e., within 24 hours af-
ter the substance was delivered). The proposed regulations also require a
new reporting time frame for mail or licensed express delivery services of
.not later than 72 hours after the substance was shipped from the
pharmacy.. Additionally, the amendments create a requirement for .zero
reporting. when no controlled substances have been dispensed by a practi-
tioner or pharmacy to ensure that at least every 14 days the Bureau of
Narcotic Enforcement has been informed that no controlled substances
have been dispensed. The amendments provide for waivers of these
requirements when appropriate. These requirements may necessitate com-
puter programming services initially.
Professional Services:
The proposed amendments would require pharmacies to report con-
trolled substance dispensing information to the Department of Health
within 24 hours of delivering the controlled substance. Previously,
dispensers were required to report once a month. This change will likely
require additional computer programming development by the dispenser
or their contracted vendor. A survey of existing chain pharmacies and
vendors that support independent pharmacies indicated programming costs
associated with implementation of the reporting requirement could be up
to approximately $15,000. Other vendors indicated that they are currently
able to meet the requirement with minimal lead time and costs. Dispens-
ing practitioners that currently utilize the existing online manual data
reporting system will be able to continue to utilize this Department-
supported reporting system with no additional costs anticipated. Practitio-
ners will need to obtain a Health Commerce System account, as well as
internet service for themselves and/or their designees.
Compliance Costs:
Costs to Private Regulated Parties:
For pharmacies and dispensers to meet the reporting requirements speci-
fied in this rule, an estimate of no cost to approximately $15,000 can be
anticipated. These costs are reflective of associated computer program-
ming necessitated by the more frequent reporting of controlled substance
data to the Department. There is no fee, tax, or transactional cost associ-
ated with creating a Health Commerce System account or accessing the
PMP.
Costs to State Government and Local Government:
The proposed rule does not require local government to perform any
additional tasks as governmental entities, but will result in additional
administrative tasks by the Department of Health as discussed below.
Therefore, it is not anticipated to have an adverse fiscal impact on local
government, but the Department of Health anticipates increased adminis-
trative costs as discussed below. It should be noted that 95 pharmacies
throughout the State are owned by government entities and costs will be
incurred by those government-owned pharmacies in the same manner as
independent and chain pharmacies. Real-time updates and consultation of
the PMP with regard to controlled substances could reduce the number of
incidents of diversion and will likely reduce the volume and negative
impacts of over-prescribing the associated costs to the State. Therefore,
the regulations may have a positive fiscal impact in that regard.
A cure period is not required to be incorporated in the amendments pur-
suant to Chapter 524 of the Laws of 2011 insofar as the proposed amend-
ments do not involve the establishment or modification of a violation or of
penalties associated with a violation.
Economic and Technological Feasibility:
There are expected to be initial costs to dispensers to meet the 24-hour
reporting requirement. After initial programming is completed, it is
expected that these changes will reduce the amount of time spent by em-
ployees reviewing and submitting controlled substance data to the
Department.
The current PMP has been operating on-line for approximately three
and a half years, and is currently available to all DEA-licensed practitioners
within New York State. In an attempt to encourage use, the Department is
investing resources in updating the current system to make it more user-
friendly and to provide additional functions.
The technological requirements to access the PMP are minimal.
Practitioners, pharmacists, and their designees will need access to the
internet and a Health Commerce System account. The proposed amend-
ments also provide for waivers of these requirements when appropriate.
There is no fee, tax, or transactional cost associated with creating a Health
Commerce System account or accessing the PMP.
Minimizing Adverse Impact:
To minimize any undue burden on a particular practitioner, the amend-
ments provide for the use of a designee and PMP program functionalities
to allow for multiple searches at one time to aid in potential work flow
changes. The amendments also provide for a waiver process for practitio-
ners to be exempted from the duty to consult the PMP based upon
technological limitations that are not reasonably within the control of the
practitioner or other exceptional circumstance demonstrated by the
practitioner. Additionally, the amendments provide for a reporting waiver
process for pharmacies and practitioners.
Small Business and Local Government Participation:
During the drafting of these amendments, the Department consulted
with the State Education Department.s Board of Pharmacy. The Depart-
ment also consulted with representatives from the Pharmaceutical Society
of the State of New York, the membership of which consists of pharmacists
and others who have an interest in the practice of pharmacy, including
owners of small businesses, vendors, employees of pharmacies and em-
ployees of private and government institutions, and the New York Chapter
of the American Society of Consultant Pharmacists, the membership of
which consists of pharmacists who provide consulting services to private
or government owned residential health care facilities. Issues and com-
ments relevant to dispensing, record keeping, and consulting were
discussed at open forums such as the New York State Pharmacy Confer-
ence meetings and the Pharmacy Advisory Committee (PAC) meetings.
Pharmacy conferences are held quarterly for the purpose of sharing infor-
mation among stakeholders in the practice of pharmacy, including
representatives from the colleges of pharmacy in New York State, govern-
ment agencies, regulatory agencies, and all pharmacy practice settings.
The PAC acts as an advisory body to the Department of Health on
pharmacy issues related to the Medicaid Program. The Department also
consulted with the National Association of Chain Drug Stores, an organi-
zation dedicated to advancing the interests and objectives of the chain
community pharmacy industry, and with various other pharmacy leaders
and stakeholders. The amendments were drafted taking into consideration
the pharmacy community.s comments and suggestions with respect to the
current laws and regulations and how the amendments would affect the
overall dispensing process.
The Department consulted with the Medical Society of the State of
New York, an organization dedicated to promoting and maintaining high
standards in medical education and in the practice of medicine in an effort
to ensure that quality medical care is available to the public. The Depart-
ment also consulted with the Greater New York Hospital Association and
the New York City Health and Hospitals Corporation. Input was also
received from the Office of Professional Medical Conduct, the New York
Chapter of the American College of Physicians and the workgroup
established under Public Health Law Section 3309-a to provide input re-
lated to the implementation of the PMP. Some practitioners and practi-
tioner professional societies expressed concerns regarding the expected
cost to practitioners as well as technological barriers facing technologi-
cally naï practitioners. The Department is confident that the exceptions
and waiver process provided for in the statute and the regulatory amend-
ments address these concerns.
Rural Area Flexibility Analysis
Types and Estimated Numbers of Rural Areas:
The amendments apply uniformly throughout the state, including rural
NYS Register/June 19, 2013 Rule Making Activities
11
areas. Outside of major cities and metropolitan population centers, the ma-
jority of counties in New York contain rural areas. These can range in
extent from small towns and villages and their surrounding areas, to loca-
tions that are sparsely populated. Rural areas are defined as counties with
a population less than 200,000 and counties with a population of 200,000
or greater that have towns with population densities of 150 persons or
fewer per square mile. According to the Education Department.s Board of
Pharmacy, as of January 7, 2013, there are a total of 2,030 registered
pharmacies and 8,651 registered pharmacists located in rural counties,
which account for 45.6% of the pharmacists and 40.2% of the pharmacies
registered in the State of New York. The total number of DEA registered
practitioners in rural areas (i.e., those with the authority to write a con-
trolled substance prescription) is 43,593, representing 61% of the total
number of DEA registered prescribers. These practitioners include medi-
cal doctors, dentists, nurse practitioners, physician assistants, podiatrists
and midwifes.
Reporting, Recordkeeping and Other Compliance Requirements; and
Professional Services:
These amendments are required to facilitate the changes and the addi-
tions to the Public Health Law enacted by Chapter 447 of the Laws of
2012 which, among other things, require real-time reporting to the PMP
by pharmacies and dispensing practitioners and add a duty to consult the
PMP by practitioners who are prescribing controlled substances. Under
current regulations, pharmacies and dispensers are required to report con-
trolled substance dispensing data to the Department on a monthly basis.
The proposed amendments would require more frequent reporting of con-
trolled substance dispensing data (i.e., within 24 hours after the substance
was delivered). The proposed regulations also require a new reporting
time frame for mail or licensed express delivery services of .not later than
72 hours after the substance was shipped from the pharmacy.. Addition-
ally, the amendments create a requirement for .zero reporting. when no
controlled substances have been dispensed by a practitioner or pharmacy
to ensure that at least every 14 days the Bureau of Narcotic Enforcement
has been informed that no controlled substances have been dispensed.
These requirements may necessitate computer programming services
initially. The amendments provide for waivers of these reporting require-
ments when appropriate. The requirements are identical for both rural ar-
eas and non-rural areas of the State.
Costs:
For pharmacies and dispensers to meet the reporting requirements speci-
fied in this rule, an estimate of no cost to approximately $15,000 can be
anticipated. These costs are reflective of associated computer program-
ming necessitated by the more frequent reporting of controlled substance
data to the Department. The proposed amendments also provide for waiv-
ers of these requirements for economic hardship, technological limitation
that are not reasonably within the control of the pharmacy, or other dem-
onstrated exceptional circumstances. There is no fee, tax, or transactional
cost associated with creating a Health Commerce System account or ac-
cessing the PMP. Estimated costs are not anticipated to be different for ru-
ral areas versus non-rural areas of the State.
Minimizing Adverse Impact:
To minimize any undue burden on a particular practitioner, the amend-
ments provide for a waiver process for practitioners to be exempted from
the duty to consult the PMP based upon technological limitations that are
not reasonably within the control of the practitioner or other exceptional
circumstance demonstrated by the practitioner. Additionally, the amend-
ments provide for a reporting waiver process for pharmacies and
practitioners. It is anticipated that these waiver categories will sufficiently
address the burdens of rural providers.
Rural Area Participation:
During the drafting of these amendments, the Department consulted
with various statewide groups whose constituencies include rural areas,
e.g.: the State Education Department.s Board of Pharmacy, the Pharma-
ceutical Society of the State of New York and the New York Chapter of
the American Society of Consultant Pharmacists. Pharmacy conferences
were also held quarterly for the purpose of sharing information among
stakeholders in the practice of pharmacy, including representatives from
the colleges of pharmacy in New York State, government agencies, regula-
tory agencies, and all pharmacy practice settings. The Department also
consulted with the National Association of Chain Drug Stores, an organi-
zation dedicated to advancing the interests and objectives of the chain
community pharmacy industry in rural and metropolitan areas, and with
various other pharmacy leaders and stakeholders. Input was received from
the workgroup established under Public Health Law Section 3309-a to
provide guidance related to the implementation of the PMP. The amend-
ments were drafted taking into consideration the pharmacy community.s
comments and suggestions with respect to the current laws and regulations
and how the amendments would affect the overall dispensing process.
The Department also consulted with the Medical Society of the State of
New York and the Greater New York Hospital Association.
Job Impact Statement
A Job Impact Statement is not included because the Department has
concluded that the proposed regulatory amendments will not have a
substantial adverse effect on jobs given that the amendments are simply
implementing an underlying requirement imposed by the legislature
through the Public Health Law. The amendments provide for the duty of a
practitioner to consult the PMP, as well as the real-time reporting of
dispensed controlled substances by pharmacies and practitioners, and will
not have a substantial adverse effect upon jobs and employment
opportunities.
Long Island Power Authority
NOTICE OF ADOPTION
LIPA.s Tariff for Electric Service, Including Service
Classification No. 16
I.D. No.
LPA-11-13-00019-A
Filing Date:
2013-05-29
Effective Date:
2013-05-29
PURSUANT TO THE PROVISIONS OF THE State Administrative Pro-
cedure Act, NOTICE is hereby given of the following action:
Action taken:
The Long Island Power Authority adopted a proposal to
modify its Tariff for Electric Service to change the on-peak energy
delivery charge for residential and small commercial service under Ser-
vice Classification No. 16 and make other revisions.
Statutory authority:
Public Authorities Law, section 1020-f(z) and (u)
Subject:
LIPA.s Tariff for Electric Service, including Service Classifica-
tion No. 16.
Purpose:
To change the on-peak energy delivery charge and make other
miscellaneous revisions.
Text or summary was published
in the March 13, 2013 issue of the Regis-
ter, I.D. No. LPA-11-13-00019-P.
Final rule as compared with last published rule:
No changes.
Text of rule and any required statements and analyses may be obtained
from:
Andrew McCabe, Long Island Power Authority, 333 Earle Ovington
Blvd., Suite 403, Uniondale, NY 11553, (516) 222-7700, email:
amccabe@lipower.org
Revised Regulatory Impact Statement
A revised regulatory impact statement is not submitted with this notice
because the rule is within the definition contained in section 102(2)(a)(ii)
of the State Administrative Procedure Act.
Revised Regulatory Flexibility Analysis
A revised regulatory flexibility analysis is not submitted with this notice
because the rule is within the definition contained in section 102(2)(a)(ii)
of the State Administrative Procedure Act.
Revised Rural Area Flexibility Analysis
A revised rural area flexibility analysis is not submitted with this notice
because the rule is within the definition contained in section 102(2)(a)(ii)
of the State Administrative Procedure Act.
Revised Job Impact Statement
A revised job impact statement is not submitted with this notice because
the rule is within the definition contained in section 102(2)(a)(ii) of the
State Administrative Procedure Act.
Assessment of Public Comment
An assessment of public comment is not submitted with this notice because
the rule is within the definition contained in section 102(2)(a)(ii) of the
State Administrative Procedure Act.