EDU-40-11-00001-E Collaborative Drug Therapy Management
12/28/11 N.Y. St. Reg. EDU-40-11-00001-E
NEW YORK STATE REGISTER
VOLUME XXXIII, ISSUE 52
December 28, 2011
RULE MAKING ACTIVITIES
EDUCATION DEPARTMENT
EMERGENCY RULE MAKING
I.D No. EDU-40-11-00001-E
Filing No. 1363
Filing Date. Dec. 13, 2011
Effective Date. Dec. 13, 2011
Collaborative Drug Therapy Management
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of sections 63.7 and 63.10 of Title 8 NYCRR.
Statutory authority:
Education Law, sections 207(not subdivided), 6504(not subdivided), 6507(2)(a), 6508(1), 6801-a, 6827(4); and L. 2011, ch. 21
Finding of necessity for emergency rule:
Preservation of general welfare.
Specific reasons underlying the finding of necessity:
The proposed amendment of section 63.7 and addition of section 63.10 of the Commissioner's regulations is necessary to conform the Commissioner's regulations to Chapter 21 of the Laws of 2011. The legislation was signed by the Governor on May 17, 2011, and adds a new section 6801-a of the Education Law authorizing the Collaborative Drug Management Therapy Demonstration Program for physicians and pharmacists working under the auspices of a teaching hospital. The new law, which sunsets three years from its effective date, restricts collaboration to pharmacists who meet specified education and experience requirements. In addition, the statute provides that pharmacists participating in CDTM complete five hours of relevant continuing education. The legislation authorizes the Commissioner to develop regulations necessary to implement the new law.
Consistent with the statute, the proposed amendment will add a new section 63.10 and amend section 63.7 of the Commissioner's Regulations to establish requirements necessary for implementation of Chapter 21 of the Laws of 2011. Because the Board of Regents meets at scheduled intervals, the earliest the proposed amendment could be presented for regular adoption, after publication of a Notice of Proposed Rule Making in the State Register and expiration of the 45-day public comment period prescribed in the State Administrative Procedure Act (SAPA), is at the December 12-13, 2011 meeting of the Board of Regents. If adopted at the December Regents meeting, the earliest the amendment could become effective pursuant to SAPA is December 28, 2011, the date of publication of the Notice of Adoption in the State Register. However, Chapter 21 of the Laws of 2011 takes effect on September 14, 2011, and directs that any rule or regulation necessary for the law's implementation be made and completed on or before such effective date.
Emergency action is necessary for the preservation of the public health and general welfare to immediately conform the Commissioner's regulations to Chapter 21 of the Laws of 2011, and thereby ensure that the Collaborative Drug Management Therapy Demonstration Program is implemented in a timely manner and consistent with statutory requirements.
Emergency action is also necessary to ensure that the emergency rule that was adopted at the September Regents meeting remains continuously in effect until it can be adopted as a permanent rule. The proposed rule was adopted as an emergency action at the September 2011 Regents meeting, effective September 14, 2011. A Notice of Proposed and Emergency Rule Making was published in the State Register on October 5, 2011. The September emergency rule will expire on December 12, 2011 and the permanent rule will not become effective until January 4, 2012. Therefore, emergency action is necessary to ensure that the emergency rule remains continuously in effect until such time as it can be adopted as a permanent rule.
Subject:
Collaborative drug therapy management.
Purpose:
Establish requirements to implement the Collaborative Drug Management Therapy Demonstration Program.
Text of emergency rule:
1. Subparagraph (i) of paragraph (2) of subdivision (b) of section 63.7 of the Regulations of the Commissioner of Education is amended, effective December 13, 2011, as follows:
(i) [Exemptions. The following licensees shall be exempt from the continuing education requirements, as prescribed in subdivision (c) of this section:
(a) licensees for the triennial registration period during which they are first licensed to practice pharmacy in New York State, exclusive of those first licensed to practice pharmacy in New York State pursuant to an endorsement of a license of another jurisdiction;
(b) licensees whose first registration date following January 1, 1997 occurs prior to January 1, 1998, for periods prior to such registration date; and
(c) licensees] Exemption. Licensees who are not engaged in the practice of pharmacy, as evidenced by not being registered to practice in New York State, shall be exempt from the continuing education requirements, as prescribed in subdivision (c) of this section, except as otherwise provided in paragraph (c)(2) of this section to meet the education requirements for the resumption of practice after a lapse in practice for a licensee who has not lawfully practiced continuously in another jurisdiction throughout such lapse period.
2. Paragraph (1) of subdivision (c) of section 63.7 of the Regulations of the Commissioner of Education is amended, effective December 13, 2011, as follows:
(1) During each triennial registration period, meaning a registration period of three years' duration, an applicant for registration shall complete at least 45 hours of formal continuing education acceptable to the department, as defined in paragraph (4) of this subdivision, provided that no more than 22 hours of such continuing education shall consist of self-study courses. During registration periods beginning on or after September 1, 2003, a licensee shall complete as part of the 45 hours of formal continuing education, or pro-ration thereof, at least three hours of formal continuing education acceptable to the department in the processes and strategies that may be used to reduce medication and/or prescription errors. Any licensee participating in collaborative drug therapy management pursuant to Education Law section 6801-a, shall complete as part of the 45 hours of formal continuing education, or pro-ration thereof, at least five hours of formal continuing education acceptable to the department in the area or areas of practice generally related to any collaborative drug therapy management protocols to which the pharmacist may be subject, provided that such continuing education shall not be completed as self-study. [Any licensed pharmacist whose first registration date following January 1, 1997 occurs less than three years from that date, but on or after January 1, 1998, shall complete continuing education hours on a prorated basis at the rate of one and one-quarter hours of acceptable formal continuing education per month for the period beginning January 1, 1997 up to the first registration date thereafter. Such continuing education shall be completed during the period beginning January 1, 1997 and ending before the first day of the new registration period or at the option of the licensee during any time in the previous registration period.]
3. Section 63.10 of the Regulations of the Commissioner of Education is added, effective December 13, 2011, to read as follows:
§ 63.10 Collaborative drug therapy management.
(a) Applicability. This section shall apply only to the extent that the applicable provisions in Education Law sections 6801 and 6801-a, authorizing certain pharmacists to participate in collaborative drug therapy management, have not expired or been repealed.
(b) Experience requirement for participating pharmacists.
(1) As used in Education Law section 6801-a(2)(b), a year of experience shall mean not less than 1,680 hours of work as a pharmacist within a period of one calendar year.
(2) In order to be counted as a year of experience that includes clinical experience in a health facility, such experience shall include, on average, not less than 15 hours per week of clinical experience which involves consultation with physicians with respect to drug therapy, as determined by the facility that employs or is affiliated with the pharmacist.
This notice is intended
to serve only as a notice of emergency adoption. This agency intends to adopt the provisions of this emergency rule as a permanent rule, having previously submitted to the Department of State a notice of proposed rule making, I.D. No. EDU-40-11-00001-EP, Issue of October 5, 2011. The emergency rule will expire February 10, 2012.
Text of rule and any required statements and analyses may be obtained from:
Mary Gammon, New York State Education Department, 89 Washington Avenue, Room 138, Albany, New York 12234, (518) 473-8296, email: legal@mail.nysed.gov
Regulatory Impact Statement
1. STATUTORY AUTHORITY:
Section 207 of the Education Law grants general rule-making authority to the Board of Regents to carry into effect the laws and policies of the State relating to education.
Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.
Subparagraph (a) of subdivision (2) of section 6507 of the Education Law authorizes the Commissioner to promulgate regulations in administering the admission to the practice of the professions.
Subdivision (1) of section 6508 of the Education Law provides that state boards for the professions shall assist the Board of Regents and Department on matters of professional licensing.
Section 6801-a of the Education Law establishes the Collaborative Drug Therapy Management (CDTM) Demonstration Program.
Subdivision (4) of section 6827 of the Education Law authorizes the Commissioner of Education to promulgate regulations setting standards for coursework that may be used to satisfy continuing education requirements for pharmacists.
Section (5) of chapter 21 of the Laws of 2011 authorizes and directs the promulgation of any rule necessary for the implementation of the CDTM demonstration program.
2. LEGISLATIVE OBJECTIVES:
On May 17, 2011 Governor Cuomo signed into law Chapter 21 of the Laws of 2011, which added a new section 6801-a of the Education Law authorizing the Collaborative Drug Therapy Management (CDTM) Demonstration Program for physicians and pharmacists working under the auspices of a teaching hospital. The new law, which sunsets three years from its effective date, restricts collaboration to pharmacists who meet specified education and experience requirements. In addition, the statute provides that pharmacists participating in CDTM complete five hours of relevant continuing education, and requires the Department, in consultation with the Department of Health, to prepare a report to the legislature on the implementation of the CDTM. The report will review the extent to which CDTM was implemented, and will examine whether, and the extent to which, it contributed to improvement of quality of care for patients, reduced the risk of medication error, reduced unnecessary health care expenditures, and was otherwise in the public interest.
The legislation authorizes the Department to develop regulations necessary to implement the new law. The proposed rule establishes standards for the experience required for a pharmacist to participate in CDTM, and revises continuing education requirements to reflect the new statutory provisions for pharmacists engaging in CDTM.
Concurrently, the proposed rule updates the continuing education regulations for pharmacists by deleting out-dated references.
3. NEEDS AND BENEFITS:
The proposed rule is necessary to implement Chapter 21 of the Laws of 2011, which establishes the Collaborative Drug Therapy Management (CDTM) Demonstration Program.
To date, 46 other states have already authorized collaboration between medication prescribers and pharmacists for the purpose of improving therapeutic outcomes from medication therapies. The purpose of such collaboration is to reduce morbidity and mortality, reduce emergency room visits and hospital admissions, and otherwise reduce health care spending. Included among the many disease states in which such improvements have been documented are asthma, diabetes, and clotting disorders or other indications for anticoagulation.
4. COSTS:
(a) Costs to State government: The proposed rule is necessary to implement Chapter 21 of the Laws of 2011 and imposes no additional costs on State government, other than those inherent in the statute.
(b) Costs to local government: The proposed rule relates solely to the requirement for licensees engaged in the practice of pharmacy and does not impose any costs on local government.
(c) Cost to private regulated parties: The proposed rule will not increase costs, and may provide cost-savings to regulated parties, patients, institutions and patients. Therefore, there will be no additional costs to private regulated parties.
(d) Costs to the regulatory agency for implementation and continued administration of the rule: The proposed rule imposes no additional costs on the State Education Department, other than those inherent in the statute.
5. LOCAL GOVERNMENT MANDATES:
The proposed rule relates solely to the requirement for licensees engaged in the practice of pharmacy and does not impose any programs, service, duty, or responsibility upon local governments.
6. PAPERWORK:
The proposed rule imposes no new reporting requirements.
7. DUPLICATION:
The proposed rule does not duplicate other existing state or federal requirements.
8. ALTERNATIVES:
The proposed rule is necessary to implement Chapter 21 of the Laws of 2011, which establishes the Collaborative Drug Therapy Management (CDTM) demonstration program. There are no viable alternatives to the proposed rule and none were considered.
9. FEDERAL STANDARDS:
Federal standards do not apply, nor does the proposed rule exceed federal standards.
10. COMPLIANCE SCHEDULE:
Consistent with the statute, the proposed rule would become effective on September 14, 2011, at which time licensees and participating facilities must comply with the proposed amendments if engaged in Collaborative Drug Therapy Management. Participation in CDTM is voluntary and it is anticipated that regulated parties will be able to comply with the rule's provisions by its effective date.
Regulatory Flexibility Analysis
The proposed rule is necessary to implement the Collaborative Drug Therapy Management (CDTM) demonstration program pursuant to Chapter 21 of the Laws of 201, and relates to the practice of pharmacy, defining who and under what conditions certain pharmacists may engage in collaborative drug therapy management with physician prescribers of medications. The proposed rule also revises the continuing education requirements for pharmacists to conform with the CDTM demonstration program and to delete certain outdated provisions. The proposed rule will not impose any reporting, recordkeeping, or other compliance requirements, or any adverse economic impact, on small businesses or local governments. Because it is evident from the nature of the proposed rule that it will not affect small businesses or local governments, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a regulatory flexibility analysis for small businesses and local governments is not required and one has not been prepared.
Rural Area Flexibility Analysis
1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:
The rule will apply to the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less. Of the 22,344 pharmacists registered by the State Education Department, 2,821 pharmacists report their permanent address of record is in a rural county.
2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:
The proposed rule is necessary to implement Chapter 21 of the Laws of 2011, which establishes the Collaborative Drug Therapy Management (CDTM) Demonstration Program. The proposed rule's provisions allow certain pharmacists, practicing within teaching hospitals, to engage in CDTM with physician prescribers of medications. The proposed rule will also delete continuing education provisions that are no longer applicable. The proposed rule will not impose reporting, recordkeeping, or other compliance requirements and will not require the use of additional professional services.
3. COSTS:
The proposed rule is necessary to implement Chapter 21 of the Laws of 2011 and does not impose any additional costs on regulated parties. The proposed rule will not increase costs, and may provide cost-savings to regulated parties, patients, institutions and patients.
4. MINIMIZING ADVERSE IMPACT:
Following discussions, including obtaining input from practicing professionals, the State Board of Pharmacy has considered the terms of the proposed amendments to Regulations of the Commissioner of Education and has recommended the changes. Additionally, the measures have been shared with educational institutions, professional associations, and practitioners representing the profession of pharmacy. The amendments are supported by representatives of these sectors. The proposals make no exception for individuals who live in rural areas. The Department has determined that such requirements should apply to all pharmacists and pharmacies State-wide and regardless of their geographic location, to ensure a uniform standard of practice across the State. Accordingly, it is neither appropriate nor warranted to establish different requirements for entities located in rural areas.
5. RURAL AREA PARTICIPATION:
Comments on the proposed rule were solicited from Statewide organizations representing all parties having an interest in the practice of pharmacy. Included in this group were members of the State Board of Pharmacy, educational institutions, and professional associations representing the pharmacy profession, such as the Pharmacists Society of the State of New York and the New York State Council of Health System Pharmacists. These groups, which have representation in rural areas, have been provided notice of the proposed rule making and opportunity to comment on the regulations.
Job Impact Statement
The proposed rule is necessary to implement the Collaborative Drug Therapy Management (CDTM) demonstration program pursuant to Chapter 21 of the Laws of 2011, and relates to the practice of pharmacy, defining who and under what conditions certain pharmacists may engage in CDTM with physician prescribers of medications. The proposed rule also revises the continuing education requirements for pharmacists to conform with the CDTM demonstration program and to delete certain outdated provisions. The proposed rule will not adversely impact jobs and employment opportunities. Because it is evident from the nature of the proposed rule that it will not affect job and employment opportunities, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.
