EDU-11-14-00002-E Interpretation and Translation Services for Limited English Proficient (LEP) Individuals by Mail Order Pharmacies

4/16/14 N.Y. St. Reg. EDU-11-14-00002-E

NEW YORK STATE REGISTER

VOLUME XXXVI, ISSUE 15

April 16, 2014

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

EMERGENCY RULE MAKING

 

I.D No. EDU-11-14-00002-E

Filing No. 260

Filing Date. Mar. 28, 2014

Effective Date. Mar. 30, 2014

Interpretation and Translation Services for Limited English Proficient (LEP) Individuals by Mail Order Pharmacies

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

Action taken:

Amendment of section 63.11 of Title 8 NYCRR.

Statutory authority:

Education Law, sections 207 (not subdivided), 6504 (not subdivided), 6507(2)(a), 6810(1) and 6829(4); and L. 2012, ch. 57, part V

Finding of necessity for emergency rule:

Preservation of public health and general welfare.

Specific reasons underlying the finding of necessity:

The purpose of the proposed amendment is to implement Education Law section 6829(4), as added by Section 3 of Part V of Chapter 57 of the Laws of 2012, which establishes interpretation and translation requirements for all mail order pharmacies conducting business in New York State. The proposed amendment implements the provisions of section 6829(4) of the Education Law that, effective March 30, 2014, requires all mail order pharmacies sending prescriptions to individuals in New York State to provide interpretation and translation services for Limited English Proficient (LEP) individuals. It also subjects mail order pharmacies to the same interpretation and translation services requirements as are now required for covered pharmacies within the state. The information for which competent oral interpretation and translation services shall be provided will be prescription medication labels, warning labels and other written materials.

Because the Board of Regents meets at fixed intervals, the earliest the proposed amendment can be presented for adoption as a permanent rule, after expiration of the required 45-day public comment period provided for in State Administrative Procedure Act (SAPA) section 202(1) and (5), would be the May 19-20, 2014 Regents meeting. Furthermore, pursuant to SAPA section 203(1), the earliest effective date of the proposed amendment, if adopted at the May meeting, would be June 4, 2014, the date a Notice of Adoption would be published in the State Register. However, the provisions of Education Law section 6829(4) become effective on March 30, 2014.

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 to timely implement Education Law section 6829(4), as added by Section 3 of Part V of Chapter 57 of the Laws of 2012, so that LEP individuals can receive competent oral interpretation services and translation services from the mail order pharmacies that fill their prescriptions.

It is anticipated that the proposed amendment will be presented for adoption as a permanent rule at a subsequent Regents meeting, after publication of the proposed amendment in the State Register and expiration of the 45-day public comment period prescribed by the State Administrative Procedure Act.

Subject:

Interpretation and translation services for Limited English Proficient (LEP) individuals by mail order pharmacies.

Purpose:

To implement section 6829(4) of the Education Law, as added by part V of chapter 57 of the Laws of 2012.

Text of emergency rule:

1. Paragraph (7) of subdivision (a) of section 63.11 of the Regulations of the Commissioner of Education is added, effective March 30, 2014, to read as follows:

(7) Mail order pharmacy shall mean a pharmacy that dispenses most of its prescriptions through the United States postal service or other delivery system.

2. Subdivision (b) of section 63.11 of the Regulations of the Commissioner of Education is amended, effective March 30, 2014, as follows:

(b) Provision of competent oral interpretation services and translation services. Except as otherwise provided in subdivision (e) of this section:

(1) For purposes of counseling an individual about his or her prescription medications or when soliciting information necessary to maintain a patient medication profile, each covered pharmacy and mail order pharmacy shall provide free, competent oral interpretation services and translation services in such individual’s preferred pharmacy primary language to each LEP individual requesting such services or when filling a prescription that indicates that the individual is limited English proficient at such covered pharmacy or mail order pharmacy, unless the LEP individual is offered and refuses such services.

(2) With respect to prescription medication labels, warning labels and other written materials, each covered pharmacy and mail order pharmacy shall provide free, competent oral interpretation services and translation services to each LEP individual filling a prescription at such covered pharmacy or mail order pharmacy in such individual’s preferred pharmacy primary language, unless the LEP individual is offered and refuses such services or the medication labels, warning labels and other written materials have already been translated into the language spoken by the LEP individual.

(3) Translation and competent oral interpretation shall be provided in the preferred pharmacy primary language of each LEP individual, provided that no covered pharmacy or mail order pharmacy shall be required to provide translation or competent oral interpretation of more than seven languages.

(4) The services required by this subdivision may be provided by a staff member of the covered pharmacy or mail order pharmacy or a third-party contractor. Such services shall be provided on an immediate basis but need not be provided in-person or face-to-face.

3. Paragraph (1) of subdivision (c) of section 63.11 of the Regulations of the Commissioner of Education is amended, effective March 30, 2014, as follows:

(1) In accordance with Education Law section 6829(3), each covered pharmacy shall conspicuously post a notice to inform LEP individuals of their rights to free, competent oral interpretation services and translation services. Such notice shall include the following statement in English and in each of the pharmacy primary languages: "Point to your language. Language assistance will be provided at no cost to you." With each initial transaction with patients seeking mail order services, mail order pharmacies shall provide printed materials in English and in each of the pharmacy primary languages, explaining the availability of competent oral interpretation services and translation services. In addition, mail order pharmacies that are nonresident establishments shall provide any required information pursuant to section 63.8(b)(6) of this Part in English and in each of the pharmacy primary languages.

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-11-14-00002-P, Issue of March 19, 2014. The emergency rule will expire June 25, 2014.

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]

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 and the practice of the professions.

Subdivision (1) of section 6810 of the Education Law, as amended by section 2 of Part V of Chapter 57 of the Laws of 2012, provides that all prescription drug labels shall conform to rules and regulations as promulgated by the Commissioner pursuant to section 6829 of the Education Law.

Subdivision (4) of section 6829 of the Education Law, as added by section 3 of Part V of Chapter 57 of the Laws of 2012, requires the Commissioner, in consultation with the Commissioner of the Department of Health (DOH), to promulgate regulations, effective March 30, 2014, requiring all mail order pharmacies conducting business in New York State to provide free, competent oral interpretation services and translation services to persons filling a prescription through such mail order pharmacies whom are identified as Limited English Proficient (LEP) individuals. Specifically, Education Law § 6829(4) requires the regulations to address the concerns of affected stakeholders and reflect the findings of a thorough analysis of issues including: (a) how persons shall be identified as LEP individuals, in light of the manner by which prescriptions are currently received by mail order pharmacies; (b) which languages shall be considered; (c) the manner and circumstances in which competent oral interpretation services and translation services shall be provided; (d) the information for which competent oral interpretation services and translation services shall be provided; (e) anticipated utilization, available resources, and cost considerations; and (f) standards for monitoring compliance with the regulations and ensuring the delivery of quality competent oral interpretation services and translation services.

2. LEGISLATIVE OBJECTIVES:

The proposed amendment carries out the intent of the aforementioned statutes, particularly section 3 of the Part V of Chapter 57 of the Laws of 2012 that amended Article 137 of the Education Law by adding a new section 6829, which, inter alia, requires mail order pharmacies sending prescriptions to individuals in New York State to provide interpretation and translation services to LEP individuals. The proposed amendment subjects mail order pharmacies to the same interpretation and translation requirements that have been required for covered pharmacies within New York State since 2013. Specifically, the proposed amendment requires that with each initial transaction with patients seeking mail order pharmacy services, in addition to English, mail order pharmacies provide printed materials in Chinese, Italian, Russian and Spanish, explaining the availability of competent oral interpretation services and translation services. Persons will be identified as LEP individuals when they request such oral interpretation services and translation services or when such mail order pharmacy fills a prescription that indicates that the individual is a LEP individual. The manner and circumstances in which competent oral interpretation services and translation services will be provided is by a staff member of the mail order pharmacy or third-party contractor and services will be provided on an immediate basis but need not be provided in-person or face-to-face. The information for which competent oral interpretation and translation services shall be provided will be prescription medication labels, warning labels and other written materials. With respect to anticipated utilization, available resources, and cost considerations, based upon experience with the existing requirements for translation services in the New York City metropolitan area, the proposed requirements should prove to be neither costly nor logistically difficult for mail order pharmacies. Additionally, regarding standards for monitoring compliance with the regulations and ensuring the delivery of quality competent oral interpretation services and translation services, as in all such matters, complaints of non-compliance will be investigated and since out-of-state pharmacies require registration with the Department, they are also subject to the Department’s professional discipline processes.

3. NEEDS AND BENEFITS:

The purpose of the proposed rule is to ensure that, similar to covered pharmacies, mail order pharmacies that conduct business in New York State provide LEP individuals with specified translation and interpretation services. The proposed amendment is necessary to conform the Regulations of the Commissioner of Education to Section 3 of Part V of Chapter 57 of the Laws of 2012.

As required by statute, the proposed rule is also needed to establish the requirements for the provision of interpretation and translation services by mail order pharmacies that send prescriptions to the LEP individuals within New York State.

4. COSTS:

(a) Costs to State government. The proposed rule implements statutory requirements and establishes standards as directed by statute, and will not impose any additional costs on State government beyond those imposed by the statutory requirements.

(b) Costs to local government. There are no additional costs to local governments.

(c) Cost to private regulated parties. The proposed rule does not impose any additional costs on regulated parties beyond those imposed by statute.

(d) Cost to the regulatory agency. The proposed rule does not impose any additional costs on the Department beyond those imposed by statute.

5. LOCAL GOVERNMENT MANDATES:

The proposed rule implements the requirements of section 6829(4) of the Education Law, as added by Section 3 of Part V of Chapter 57 of the Laws of 2012. It does not impose any program, service, duty, or responsibility upon local governments.

6. PAPERWORK:

The proposed rule imposes no new reporting requirements.

7. DUPLICATION:

The proposed amendment is necessary to implement Section 3 of Part V of Chapter 57 of the Laws of 2012. There are no other State or Federal requirements on the subject matter of this amendment. Therefore, the proposed amendment does not duplicate other existing State or Federal requirements.

8. ALTERNATIVES:

The 2012 New York State budget legislation included certain amendments to the Education Law which are commonly referred to as the SafeRx Law (L. 2012, c. 57, Part V). This law, which generally became effective March 30, 2013, includes provisions to assist LEP individuals who need interpretation and translation services when filling prescriptions at covered pharmacies. Effective May 30, 2013, the Board of Regents approved regulations affecting those covered pharmacies located within New York State. Following a series of open forums and consultations with stakeholders, the Regents accepted the recommendation that the entire State be considered a single “region.” In accordance with the statutory requirements and the analysis of census data, this determination resulted in a requirement that interpretation and translation services be provided in four languages, in addition to English. Other regional determinations were rejected since most led to fewer languages being covered in almost all upstate localities. Therefore, covered New York State pharmacies must now provide competent oral interpretation services and translation services in Chinese, Italian, Russian and Spanish.

The 2012 legislation also required the Commissioner of Education, in consultation with the Commissioner of DOH, to promulgate regulations, effective March 30, 2014, to establish translation and interpretation requirements for mail order pharmacies. The proposed amendment is needed to conform the Regulations of the Commissioner of Education to Section 3 of Part V of Chapter 57 of the Laws of 2012.

Consideration was given to information gathered as part of the aforementioned open forums and consultations with stakeholders, as well as experience with the existing interpretation and translation services requirements for covered pharmacies, and ultimately it was decided, consistent with the above rationale for covered pharmacies, that mail order pharmacies shall be subject to the same interpretation and translation requirements that have been required for covered pharmacies within New York State since 2013. Within this context, there were no significant alternatives to the proposed amendment and none where considered.

9. FEDERAL STANDARDS:

Since, there are no applicable federal standards for the provision of interpretation and translation services to LEP individuals by mail order pharmacies, 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 Section 3 of Part V of Chapter 57 of the Laws of 2012. Mail order pharmacies conducting business in New York State must comply with the interpretation and translation services requirements for LEP individuals on the effective date of the authorizing statute, March 30, 2014. It is anticipated that licensees will be able to comply with the proposed rule by the effective date so that no additional period of time will be necessary to enable regulated parties to comply.

Regulatory Flexibility Analysis

The purpose of the proposed amendment is to implement the provisions of section 6829(4) of the Education Law, as added by Section 3 of Part V of Chapter 57 of the Laws of 2012 that, effective March 30, 2014, require all mail order pharmacies sending prescriptions to individuals in New York State to provide interpretation and translation services for Limited English Proficient (“LEP”) individuals. The proposed amendment also subjects mail order pharmacies to the same interpretation and translation services requirements as are now required for covered pharmacies within the State. Specifically, pursuant to the proposed amendment, with each initial transaction with individuals seeking mail order pharmacy services, in addition to English, mail order pharmacies will provide printed materials, in Chinese, Italian, Russian and Spanish, explaining the availability of competent oral interpretation services and translation services. Persons will be identified as LEP individuals when they request such oral interpretation services and translation services or when such mail order pharmacy fills a prescription that indicates that the individual is a LEP individual. The manner and circumstances in which competent oral interpretation services and translation services will be provided is by a staff member of the mail order pharmacy or third-party contractor and services will be provided on an immediate basis but need not be provided in-person or face-to-face. The information for which competent oral interpretation services and translation services shall be provided will be prescription medication labels, warning labels and other written materials.

The proposed amendment applies the same translation and interpretation requirements to mail order pharmacies that were established for covered pharmacies in 2013 and does not impose any additional costs on regulated parties beyond those required under the statute. Additionally, based upon experience with the existing requirements for translation services in the New York City metropolitan area, the proposed amendment should prove to be neither costly nor logistically difficult for mail order pharmacies.

The proposed amendment will affect all mail order pharmacies registered by the State Education Department (Department). The Department estimates that there are 5,044 registered pharmacies in New York State and 535 non-resident pharmacies are also registered to ship prescriptions into New York State. The Department estimates that fewer than 50 of these registered pharmacies are considered to be mail order pharmacies under the statutory definition and, of these pharmacies, none are small businesses. The proposed rule establishes translation and interpretation requirements for mail order pharmacies. It will not impose any new reporting, recordkeeping, or other compliance requirements, or have 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 NUMBER OF RURAL AREAS:

The proposed amendment 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 5,044 pharmacies registered by the State Education Department (“Department”) and the 535 non-resident registered pharmacies, the Department estimates that fewer than 50 of these registered pharmacies are considered to be mail order pharmacies under the statutory definition. Of these mail order pharmacies, one mail order pharmacy reports its permanent address of record is in a rural county.

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

The proposed amendment will apply to all mail order pharmacies conducting business in New York State. The proposed amendment implements the provisions of section 6829(4) of the Education Law, as added by Section 3 of Part V of Chapter 57 of the Laws of 2012 that, effective March 30, 2014, requires all mail order pharmacies sending prescriptions to individuals in New York State to provide interpretation and translation services for Limited English Proficient (LEP) individuals. It also subjects mail order pharmacies to the same interpretation and translation services requirements as are now required for covered pharmacies within the state. Specifically, with each initial transaction with individuals seeking mail order pharmacy services, in addition to English, mail order pharmacies will provide printed materials, in Chinese, Italian, Russian and Spanish, explaining the availability of competent oral interpretation services and translation services. Persons will be identified as LEP individuals when they request such oral interpretation services and translation services or when such mail order pharmacy fills a prescription that indicates that the individual is a LEP individual. The manner and circumstances in which competent oral interpretation services and translation services will be provided is by a staff member of the mail order pharmacy or third-party contractor and services will be provided on an immediate basis but need not be provided in-person or face-to-face. The information for which competent oral interpretation services and translation services shall be provided will be prescription medication labels, warning labels and other written materials.

The proposed amendment will not impose any additional professional services requirements on entities in rural areas.

3. COSTS:

The proposed amendment does not impose any additional costs on regulated parties beyond those required under the statute.

4. MINIMIZING ADVERSE IMPACT:

In developing the proposed amendment, the Department obtained input from representatives of the professions of nursing, medicine, podiatry, midwifery and dentistry. In addition, it held public hearings in Buffalo, Albany, and New York City. More than 20 public advocacy groups and representatives of the retail pharmacy chains have commented on the proposals. Further discussions were then held with representatives of the advocacy groups and of the retail pharmacy chains. The concerns of those commenting on the proposals were taken into account in modifying the original proposal, and the proposal represented in the proposed regulations was acceptable to both the advocacy groups and the chain retail pharmacies. The proposed regulations make no exception for individuals who live in rural areas, as the legislation did not permit such an exception. Therefore, it is not possible to establish differing compliance or reporting requirements or timetables or to exempt entities in rural areas from coverage by the proposed amendment.

5. RURAL AREAS PARTICIPATION:

Comments on the proposed amendment were solicited from the Department of Health, statewide organizations representing parties having an interest in providing services to LEP individuals and stakeholders in providing more clear direction to patients regarding their medication regimens. Included in this group were representatives of the State Boards of Pharmacy, Medicine, Nursing, Dentistry, Podiatry, and Midwifery, 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 and the New York Chain Pharmacy Association. These groups have representation from rural areas.

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

Pursuant to State Administrative Procedure Act section 207(1)(b), the 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 section 6829(4) of the Education Law, as added by Section 3 of Part V of Chapter 57 of the Laws of 2012, 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 State Education 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 10 of the Notice of Proposed Rule Making published herewith, and must be received within 45 days of the State Register publication date of the Notice.

Job Impact Statement

Section 6829(4) of the Education Law, as added by Section 3 of Part V of Chapter 57 of the Laws of 2012, establishes interpretation and translation requirements for all mail order pharmacies conducting business in New York State. The proposed amendment implements the provisions of section 6829(4) of the Education Law that, effective March 30, 2014, require all mail order pharmacies sending prescriptions to individuals in New York State to provide interpretation and translation services for Limited English Proficient (LEP) individuals. It also subjects mail order pharmacies to the same interpretation and translation services requirements as are now required for covered pharmacies within the state. Specifically, with each initial transaction with individuals seeking mail order pharmacy services, in addition to English, mail order pharmacies will provide printed materials in Chinese, Italian, Russian and Spanish, explaining the availability of competent oral interpretation services and translation services. Persons will be identified as LEP individuals when they request such oral interpretation services and translation services or when such mail order pharmacy fills a prescription that indicates that the individual is a LEP individual. The manner and circumstances in which competent oral interpretation services and translation services will be provided is by a staff member of the mail order pharmacy or third-party contractor and services will be provided on an immediate basis but need not be provided in-person or face-to-face. The information for which competent oral interpretation and translation services shall be provided will be prescription medication labels, warning labels and other written materials.

Because the proposed amendment implements specific statutory requirements and directives, any impact on jobs and employment opportunities created by establishing translation and interpretation requirements for mail order pharmacies sending prescriptions to individuals in New York State is attributable to the statutory requirement, not the proposed amendment, which simply establishes standards that conform to the requirements of the statute. In any event, the same translation and interpretation requirements were established for covered pharmacies in 2013, and the Department is not aware that those requirements significantly affected jobs or employment opportunities in those pharmacies.

Therefore, the proposed amendment will not have a substantial adverse impact on jobs 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 was not prepared.