EDU-48-15-00009-EP Extension and Expansion of the Collaborative Drug Therapy Management (CDTM) Demonstration Program for Pharmacists

12/2/15 N.Y. St. Reg. EDU-48-15-00009-EP

NEW YORK STATE REGISTER

VOLUME XXXVII, ISSUE 48

December 02, 2015

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

EMERGENCY/PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. EDU-48-15-00009-EP

Filing No. 999

Filing Date. Nov. 17, 2015

Effective Date. Dec. 13, 2015

Extension and Expansion of the Collaborative Drug Therapy Management (CDTM) Demonstration Program for Pharmacists

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Proposed Action:

Amendment of section 63.10 of Title 8 NYCRR.

Statutory authority:

Education Law, sections 207(not subdivided), 6504(not subdivided), 6507(2)(a) and 6801-a; L. 2015, ch. 238; L. 2011, ch. 21

Finding of necessity for emergency rule:

Preservation of public health and general welfare.

Specific reasons underlying the finding of necessity:

The proposed amendment to the Regulations of the Commissioner of Education is necessary to implement Chapter 238 of the Laws of 2015, which amended Education Law section 6801-a in relation to the Collaborative Drug Therapy Management (CDTM) Demonstration Program enacted in 2011 for physicians and pharmacists working under the auspices of a teaching hospital, by extending the CDTM program for an additional three year period and expanding CDTM to general hospitals and nursing homes with an on-site pharmacy staffed by a licensed pharmacist. 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.

Because the Board of Regents meets at fixed intervals, the earliest the proposed amendment can be presented for adoption on a non-emergency basis, after expiration of the required 45-day public comment period provided for in the State Administrative Procedure Act (SAPA) section 202(1) and (5), would be the February 22-23, 2016 Regents meeting. Furthermore, pursuant to SAPA section 203(1), the earliest effective date of the proposed amendment, if adopted at the February meeting, would be March 9, 2016, the date a Notice of Adoption would be published in the State Register. However, the provisions of Chapter 238 of the Laws of 2015 will become effective December 13, 2015.

Emergency action is necessary for the preservation of the public health and general welfare in order to enable the State Education Department to immediately establish requirements and otherwise conform the Commissioner’s Regulations to timely implement the provisions of Chapter 238 of the laws of 2015, so that the CDTM program can be expanded to general hospitals and nursing homes with an on-site pharmacy staffed by a licensed pharmacist.

It is anticipated that the proposed amendment will be presented for adoption as a permanent rule at the February 22-23, 2016 meeting of the Board of Regents, after publication in the State Register and expiration of the 45-day comment period on proposed rule makings required by the State Administrative Procedure Act.

Subject:

Extension and expansion of the Collaborative Drug Therapy Management (CDTM) Demonstration Program for Pharmacists.

Purpose:

To implement chapter 238 of the Laws of 2015 to extend and expand the CDTM program for pharmacists.

Text of emergency/proposed rule:

Section 63.10 of the Regulations of the Commissioner of Education is amended, effective December 13, 2015, to read as follows:

(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.]

(b) Definitions. As used in this section:

(1) Board means the State Board of Pharmacy as established by section 6804 of the Education Law.

(2) Clinical services means the collection and interpretation of patient data for the purpose of initiating, modifying and monitoring drug therapy with associated accountability and responsibility for outcomes in a direct patient care setting.

(3) Collaborative drug therapy management means the performance of clinical services by a pharmacist relating to the review, evaluation and management of drug therapy to a patient, who is being treated by a physician for a specific disease or associated disease states, in accordance with a written agreement or protocol with a voluntarily participating physician and in accordance with the policies, procedures, and protocols of the facility.

(4) Facility means:

(i) a teaching hospital or general hospital, including any diagnostic center, treatment center, or hospital-based out-patient department as defined in section 2801 of the Public Health Law; or

(ii) a nursing home with an on-site pharmacy staffed by a licensed pharmacist; provided, however, for the purposes of this section the term facility shall not include dental clinics, dental dispensaries, residential health care facilities and rehabilitation centers.

(5) Teaching hospital means a hospital licensed pursuant to Article 28 of the Public Health Law that is eligible to receive direct or indirect graduate medical education payments pursuant to Article 28 of the Public Health Law.

(6) Physician means the physician selected by or assigned to a patient, who has primary responsibility for the treatment and care of the patient for the disease and associated disease states that are the subject of the collaborative drug therapy management.

(7) Written agreement or protocol means a written document, pursuant to and consistent with an applicable state or federal requirements, that addresses a specific disease or associated disease states and that describes the nature and scope of collaborative drug therapy management to be undertaken by the pharmacists, in collaboration with the participating physician in accordance with the requirements of this section.

(c) Requirements. A pharmacist seeking to engage in collaborative drug therapy management shall submit his or her credentials, in a form determined by the department, to the department for review. Those pharmacists who the department determines to meet the requirements of paragraph (3) of this subdivision and who are employed by or otherwise affiliated with a facility shall be permitted to enter into a written agreement or protocol with a physician authorizing collaborative drug therapy management, subject to the limitations set forth in this section, within the scope of such employment or affiliation, and shall be identified as being so authorized by a designation determined by the department.

(1) As used in section 6801-a(2)(b) of the Education Law, 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 with which the pharmacist is employed or affiliated.

(3) A participating pharmacist shall:

(i)(a) have been awarded either a master of science in clinical pharmacy or a doctor of pharmacy degree;

(b) maintain a current unrestricted license; and

(c) have a minimum of two years experience, of which at least one year of such experience shall include clinical experience in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation, and such clinical experience shall be gained within the three years immediately preceding the pharmacist’s submission of his or her credentials to the department for review; or

(ii)(a) have been awarded a bachelor of science in pharmacy;

(b) maintain a current unrestricted license; and

(c) within the last seven years, have a minimum of three years experience, of which at least one year of such experience shall include clinical experience in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation, and such clinical experience shall be gained within the three years immediately preceding the pharmacist’s submission of his or her credentials to the department for review; and

(iii)(a) have residency training in a program accredited or accreditation-pending by a nationally recognized accreditation body acceptable the department; or

(b) have board certification awarded by a certification body acceptable to the department and shall include baseline and ongoing competency assessments; and

(iv) meet additional experience provisions as follows:

(a) for pharmacists seeking to engage in collaborative drug therapy management by satisfying the requirements of clauses (a) though (c) of subparagraph (i) of this paragraph, if he or she seeks to utilize residency training to satisfy the one year of clinical experience requirement, the second year of required experience shall also be clinical experience, unless such pharmacist possesses board certification that satisfies the requirements of clause (b) of subparagraph (iii) of this paragraph.

(b) for pharmacists seeking to engage in collaborative drug therapy by satisfying the requirements of clauses (a) through (c) of subparagraph (ii) of this paragraph, if he or she seeks to utilize residency training to satisfy the one year of clinical experience requirement, an additional year’s experience of the three years required shall also be clinical experience, unless such pharmacist possesses board certification that satisfies the requirements of clause (b) of subparagraph (iii) of this paragraph.

(d) Requirements for collaborative drug therapy management written agreements or protocols. A physician who is a party to a written agreement or protocol to authorize collaborative drug treatment shall be employed by or otherwise affiliated with the same facility with which the pharmacist is also employed or affiliated and their written agreement or protocol may include, and shall be limited to, the following:

(1) Adjusting or managing a drug regimen of a patient, pursuant to a patient specific order or protocol made by the patient’s physician, which may include adjusting drug strength, frequency of administration or route of administration. Adjusting the drug regimen shall not include substituting or selecting a different drug which differs from that initially prescribed by the patient’s physician unless such substitution is expressly authorized in the written order or protocol. The pharmacist shall be required to immediately document in the patient’s medical record changes made to the patient’s drug therapy and shall use any reasonable means or method established by the facility to notify the patient’s other treating physicians with whom he or she does not have a written agreement or protocol regarding such changes. The patient’s physician may prohibit, by written instruction, any adjustment or change in the patient’s drug regiment by the pharmacist;

(2) Evaluating and, only if specifically authorized by the protocol and only to the extent necessary to discharge the responsibilities set forth in this section, ordering disease state laboratory tests related to the drug therapy management for the specific disease or disease state specified within the written agreement or protocol; and

(3) Only if specifically authorized by the written agreement or protocol and only to the extent necessary to discharge the responsibilities set forth in this section, ordering or performing routine patient monitoring functions as may be necessary in the drug therapy management, including the collecting and reviewing of patient histories, and ordering or checking patient vital signs, including pulse, temperature, blood pressure and respiration.

(e) Additional provisions relating to collaborative drug therapy management written agreements and protocols.

(1) The existence of a written agreement or protocol on collaborative drug therapy management and the patient’s right to choose to not participate in collaborative drug therapy management shall be disclosed to any patient who is eligible to receive collaborative drug therapy management. Collaborative drug therapy management shall not be utilized unless the patient or the patient’s authorized representative consents, in writing, to such management. If the patient or the patient’s authorized representative consents, it shall be noted on the patient’s medical record. If the patient or the patient’s authorized representative who consented to collaborative drug therapy management chooses to no longer participate in such management, at any time, it shall be noted in the patient’s medical record. In addition, the existence of the written agreement or protocol and the patient’s consent to such management shall be disclosed to the patient’s primary care physician and any other treating physician or healthcare provider.

(2) Participation in a written agreement or protocol authorizing collaborative drug therapy management shall be voluntary, and no patient, physician, pharmacist, or facility shall be required to participate.

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 February 14, 2016.

Text of rule and any required statements and analyses may be obtained from:

Kirti Goswami, State Education Department, Office of Counsel, State Education Building, Room 148, 89 Washington Ave., Albany, NY 12234, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Office of the Professions, Office of the Deputy Commissioner, State Education Department, State Education Building 2M, 89 Washington Ave., Albany, NY 12234, [phone], email: [e-mail]

Public comment will be received until:

45 days after publication of this notice.

This rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.

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 practices 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.

Section 6801-a of the Education Law establishes the Collaborative Drug Therapy Management (CDTM) Demonstration Program.

Section (5) of Chapter 21 of the Laws of 2011 authorizes and directs the promulgation of any rule or regulation necessary for the implementation of the CDTM Demonstration Program.

Chapter 238 of the Laws of 2015 extends and expands the provisions that were enacted by Chapter 21 of the Laws of 2011 by extending the CDTM Demonstration Program for an additional three years and expanding CDTM to general hospitals and nursing homes with an on-site pharmacy staffed by a licensed pharmacist.

Section (4) of Chapter 238 of the Laws of 2015 authorizes and directs the promulgation of any rule or regulation necessary for the implementation of the extension and expansion of the CDTM Demonstration Program.

2. LEGISLATIVE OBJECTIVES:

The proposed amendment carries out the intent of the aforementioned statutes and will conform the Regulations of the Commissioner of Education to Chapter 238 of the Laws of 2015, which amended Education Law section 6801-a, as added by Chapter 21 of the Laws of 2011.

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 CDTM Demonstration Program for physicians and pharmacists working under the auspices of a teaching hospital. This law, which was scheduled to sunset three years from its effective date, restricted collaboration to pharmacists who meet specified education and experience requirements. CDTM authorizes collaboration between medication prescribers and pharmacists for the purpose of improving therapeutic outcomes from medication therapies.

In 2011, the Board of Regents added section 63.10 to the Regulations of the Commissioner of Education to implement this law by establishing the standards for the experience required for a pharmacist to participate in CDTM and amended section 63.7 of the Regulations of the Commissioner of Education to revise the continuing education requirements to reflect the statutory provisions of Chapter 21 of the Laws of 2011 for pharmacists engaging in CDTM.

On September 14, 2015, Governor Cuomo signed into law Chapter 238 of the Laws of 2015, which extends and expands the provisions that were enacted in 2011 by extending the CDTM program for an additional three years and expanding CDTM to general hospitals and nursing homes with an on-site pharmacy staffed by a licensed pharmacist. Chapter 238 of the Laws of 2015 also directs the Department to prepare a report on the expanded CDTM program at least four months prior to the program’s expiration.

This legislation further authorizes the Department to develop regulations necessary to implement it. The proposed amendment establishes the experience and education requirements for pharmacists seeking to participate in CDTM. It requires such pharmacists to submit an application to the Department for approval to participate in CDTM. The proposed amendment further establishes the requirements for CDTM written agreements and protocols.

3. NEEDS AND BENEFITS:

The proposed amendment is necessary to conform the Regulations of the Commissioner of Education to Chapter 238 of the Laws of 2015, which extends and expands the CDTM Demonstration Program that was established by Chapter 21 of the Laws of 2011.

At least 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 amendment is necessary to implement Chapter 238 of the Laws of 2015 and imposes no additional costs on State government, other than those inherent in the statute.

(b) Costs to local government: The proposed amendment relates solely to the requirements of the CDTM program, including requirements for licensees engaged in the practice of pharmacy, and does not impose any additional costs on local government.

(c) Costs to private regulated parties: The proposed amendment will not increase costs and may provide cost-savings to regulated parties, patients and institutions. Therefore, there will be no additional costs to private regulated parties.

(d) Costs to the regulatory agency for implementation and continued administration of the amendment: The proposed amendment imposes no additional costs on the State Education Department, other than those inherent in the statute.

5. LOCAL GOVERNMENT MANDATES:

The proposed amendment relates solely to the requirements of the CDTM program, including requirements for licensees engaged in the practice of pharmacy, and does not impose any programs, service, duty, or responsibility upon local governments.

6. PAPERWORK:

As required by Chapter 238 of the Laws of 2015, the proposed rule will require pharmacists seeking to participate in CDTM to submit an application to the Department for approval to participate in CDTM. The proposed rule further implements the requirements of Chapter 238 of the Laws of 2015 for CDTM written practice agreements and protocols.

7. DUPLICATION:

The proposed amendment does not duplicate other existing state or federal requirements and is necessary to implement Chapter 238 of the Laws of 2015.

8. ALTERNATIVES:

The proposed rule is necessary to conform the Regulations of the Commissioner of Education to Chapter 238 of the Laws of 2015, which extends and expands the CDTM Demonstration Program that was established by Chapter 21 of the Laws of 2011. There are no viable significant alternatives to the proposed amendment and none were considered.

9. FEDERAL STANDARDS:

Since there are no applicable federal standards, the proposed amendment does not exceed any minimum federal standards for the same or similar subject areas.

10. COMPLIANCE SCHEDULE:

The proposed amendment is necessary to conform the Regulations of the Commissioner of Education to Chapter 238 of the Laws of 2015. Consistent with the statute, the proposed amendment will become effective on December 13, 2015, at which time licensees and participating facilities must comply with the proposed amendments if engaged in CDTM. Participation in CDTM is voluntary and it is anticipated that regulated parties will be able to comply with the proposed amendment by its effective date.

Regulatory Flexibility Analysis

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. This law, which was scheduled to sunset three years from its effective date, restricted collaboration to pharmacists who meet specified education and experience requirements. CDTM authorizes collaboration between medication prescribers and pharmacists for the purpose of improving therapeutic outcomes from medication therapies.

In 2011, the Board of Regents added section 63.10 to the Regulations of the Commissioner of Education to implement this law by establishing the standards for the experience required for a pharmacist to participate in CDTM and amended section 63.7 of the Regulations of the Commissioner of Education to revise the continuing education requirements to reflect the statutory provisions of Chapter 21 of the Laws of 2011 for pharmacists engaging in CDTM.

On September 14, 2015, Governor Cuomo signed into law Chapter 238 of the Laws of 2015, which extends and expands the provisions that were enacted in 2011 by extending the CDTM program for an additional three years and expanding CDTM to general hospitals and nursing homes with an on-site pharmacy staffed by a licensed pharmacist.

The proposed amendment to the Regulations of the Commissioner of Education is necessary to implement the extension and expansion of the CDTM program pursuant to Chapter 238 of the Laws of 2015. The proposed amendment establishes the experience and education requirements for pharmacists seeking to participate in CDTM. It requires such pharmacists to submit an application to the Department for approval to participate in CDTM. The proposed amendment further establishes the requirements for CDTM written agreements and protocols.

The proposed amendment 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 amendment that it will not adversely 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 NUMBERS 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 25,535 pharmacists registered by the State Education Department, 3,025 pharmacists report their permanent address of record is in a rural county.

2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:

The proposed amendment is necessary to conform the Commissioner’s Regulations to Education Law section 6801-a, as amended by Chapter 238 of the Laws of 2015. The proposed rule will require pharmacists seeking to engage in collaborative drug therapy management (CDTM) to submit an application to the Department for approval to participate in CDTM. The proposed rule further implements the requirement of Chapter 238 of the Laws of 2015 for CDTM written practice agreements and protocols. The proposed rule does not impose any professional services requirements on entities in rural areas.

3. COSTS:

The proposed rule is necessary to implement Chapter 238 of the Laws of 2015 and does not impose any additional costs on regulated parties, including those in rural areas. The proposed rule will not increase costs, and may provide cost-savings to regulated parties, patients and institutions.

4. MINIMIZING ADVERSE IMPACT:

The proposed amendment is necessary to conform the Commissioner’s Regulations to Education Law section 6801-a, as amended by Chapter 238 of the Laws of 2015. Following discussion, including obtaining input from practicing professionals, the State Board for Pharmacy has considered the terms of the proposed amendment to the Regulations of the Commissioner of Education and has recommended the change. 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, 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. Because of the nature of the proposed rule, alternative approaches for rural areas were not considered.

5. RURAL AREAS 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.

6. INITIAL REVIEW OF RULE (SAPA § 207):

Pursuant to State Administrative Procedure Act section 207(1)(b), the State Education Department proposes that the initial review of this rule shall occur in the fifth calendar year after the year in which the rule is adopted, instead of in the third calendar year. The justification for a five year review period is that the proposed amendment is necessary to implement statutory requirements in Chapter 238 of the Laws of 2015 and therefore the substantive provisions of the proposed amendment cannot be repealed or modified unless there is a further statutory change. Accordingly, there is no need for a shorter review period. The Department invites public comment on the proposed five year review period for this rule. Comments should be sent to the agency contact listed in item 16. of the Notice of Emergency Adoption and Proposed Rule Making published herewith, and must be received within 45 days of the State Register publication date of the Notice.

Job Impact Statement

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. This law, which was scheduled to sunset three years from its effective date, restricted collaboration to pharmacists who meet specified education and experience requirements. CDTM authorizes collaboration between medication prescribers and pharmacists for the purpose of improving therapeutic outcomes from medication therapies.

In 2011, the Board of Regents added section 63.10 to the Regulations of the Commissioner of Education to implement this law by establishing the standards for the experience required for a pharmacist to participate in CDTM and amended section 63.7 of the Regulations of the Commissioner of Education to revise the continuing education requirements to reflect the statutory provisions of Chapter 21 of the Laws of 2011 for pharmacists engaging in CDTM.

On September 14, 2015, Governor Cuomo signed into law Chapter 238 of the Laws of 2015, which extends and expands the provisions that were enacted in 2011 by extending the CDTM program for an additional three years and expanding CDTM to general hospitals and nursing homes with an on-site pharmacy staffed by a licensed pharmacist.

The proposed amendment to the Regulations of the Commissioner of Education is necessary to implement the extension and expansion of the CDTM program pursuant to Chapter 238 of the Laws of 2015. The proposed amendment establishes the experience and education requirements for pharmacists seeking to participate in CDTM. It requires such pharmacists to submit an application to the Department for approval to participate in CDTM. The proposed amendment further establishes the requirements for CDTM written agreements and protocols.

The proposed amendment will not have a substantial adverse impact on job and employment opportunities. Because it is evident from the nature of the proposed amendment 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.