54 N.J.R. 771(a)

VOLUME 54, ISSUE 9, MAY 2, 2022
RULE PROPOSALS

Reporter
54 N.J.R. 771(a)
NJ - New Jersey Register  >  2022  >  MAY  >  MAY 2, 2022  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement 

INTERESTED PERSONS 
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal. 
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of  N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register. 
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at      N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code. 
Agency


LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > STATE BOARD OF PHARMACY

Administrative Code Citation


Proposed New Rules: N.J.A.C. 13:39-4A
Text

 Remote Processing of Prescriptions
Authorized By: New Jersey State Board of Pharmacy, Anthony Rubinaccio, Executive Director.
Authority: N.J.S.A. 45:14-47 and 48.
Calendar Reference: See Summary for explanation of exception to calendar requirement.
Proposal Number: PRN 2022-059.
Submit comments by July 1, 2022, to:

Anthony Rubinaccio
New Jersey State Board of Pharmacy
124 Halsey Street
PO Box 45013
Newark, New Jersey 07101

or electronically at:
http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.

The agency proposal follows:
Summary
The State Board of Pharmacy (Board) is proposing new rules setting forth the requirements to allow a pharmacy to have licensed pharmacists and registered pharmacy technicians perform limited pharmaceutical functions at a location other than on the premises of a pharmacy. For example, pharmacists and pharmacy technicians may perform data entry of prescription medication information and refill authorizations. The Board believes that the proposed new rules will provide pharmacies greater flexibility in managing prescription processing operations. The proposed new rules, however, do not allow the storing or dispensing of any medication from a remote location. The proposed new rules will ensure that any prescription processing functions performed at a remote location (that is, other than on the premises of a pharmacy) are performed by qualified and appropriately trained individuals pursuant to safeguards designed to protect the confidentiality of prescription and patient information.
From 2004 through February 2020, in accordance with N.J.S.A. 45:14-48.b(10), pursuant to the pilot programs, the Board approved three pharmacies to allow certain pharmaceutical functions to be performed at remote locations. Additionally, as a result of the COVID-19 pandemic and State of Emergency, there are another 124 pharmacies participating in these remote pilot programs. As the intent of the statute is for these pilot programs to be temporary, unless and until formally recognized by regulation, the Board is promulgating proposed new rules based upon its experience with these pilot programs, taking into consideration the regulations of 12 other states that allow for the remote processing of prescriptions, and input from members of the regulated community. New N.J.A.C. 13:39-4A sets forth the rules governing remote processing of prescriptions.
N.J.A.C. 13:39-4A.1 sets forth the definitions for the subchapter. The Board defines "remote location" to specify that the location must be in New Jersey or another state, territory, or possession of the United States that is a member of the National Association of Boards of Pharmacy (NABP). The Board believes that including the requirement that the United States territories and possessions are NABP members will ensure that the licensed pharmacists who are involved with and supervise the pharmaceutical functions performed at a remote location are subject to consistent standards with respect to examination for licensure that assesses competency.
The proposed definition of "remote processing of prescriptions" at N.J.A.C. 13:39-4A.1 explicitly excludes the storage or dispensing of any medications. In addition, the proposed definition of "remote processing of prescriptions" excludes circumstances in which two or more pharmacies are involved with the pharmaceutical functions because, in accordance with N.J.A.C. 13:39-4.19, the pharmacies are subject to the requirements for centralized prescription handling.
N.J.A.C. 13:39-4A.2 sets forth the rules governing the remote processing of prescriptions by a New Jersey pharmacy. Subsection (a) provides that a pharmacy may engage in the remote processing of prescriptions provided that the pharmacy complies with the requirements of Subchapter 4A. Subsection (b) requires a pharmacy that engages in the remote processing of prescriptions to notify the Board and provide the name of the pharmacist-in-charge who will be responsible for ensuring and attesting to compliance with the requirements of Subchapter 4A. Such notification shall be made on a form supplied by the Board. As set forth at subsection (c), as part of the annual permit renewal process, a pharmacy engaging in the remote processing of prescriptions must have the permit holder and pharmacist-in-charge attest to compliance with the provisions of Subchapter 4A.
N.J.A.C. 13:39-4A.2(d) specifies that a pharmacist performing pharmaceutical functions at the remote location must hold an active New Jersey pharmacist license in good standing. Similarly, a pharmacy technician must hold an active New Jersey pharmacy technician registration in good standing. Additionally, a pharmacist must review and approve all pharmaceutical functions performed by a pharmacy technician at a remote location.
N.J.A.C. 13:39-4A.2(e) specifies that a pharmacist or pharmacy technician performing pharmaceutical functions for a pharmacy at a remote location must be an employee of the pharmacy.
N.J.A.C. 13:39-4A.2(f) requires the pharmacy engaging in the remote processing of prescriptions to have the following: 1) a written policy and procedures manual; 2) a certification by the pharmacist-in-charge that all pharmacy technicians performing pharmaceutical functions at a remote location are registered with the Board; 3) the address of the remote location(s) and a description of the work environment; 4) the security controls to ensure confidentiality of all patient information; 5) names and license or registration numbers of all personnel performing pharmaceutical functions at the remote location; and 6) a certification from each person performing pharmaceutical functions at a remote location that the required training was completed.
N.J.A.C. 13:39-4A.2(g) identifies the distinct pharmaceutical functions that a pharmacist may perform at a remote location. The pharmacist may receive, interpret, and clarify a prescription order received from a prescriber. The Board expects the prescriber to submit the prescription electronically or the patient to present it at a permitted practice site. Consistent with this expectation, subparagraph (g)1i specifies that a patient may not directly present a prescription to a pharmacist at a remote location. In addition, the pharmacist may perform the following pharmaceutical functions: data entry of prescription medication information; prospective drug utilization review; refill authorizations; interventions; product verification; patient counseling; claims submission; and claims resolution and adjudication. Paragraph (g)5 specifies that, although pharmacists may perform product verification, no medications are to be stored at or dispensed from a remote location.
N.J.A.C. 13:39-4A.2(h) provides that a pharmacy technician may perform only the following pharmaceutical functions at a remote location: data entry of prescription medication information; refill authorizations consistent with the requirements at N.J.A.C. 13:39-6.15(a)7; claims submission; and claims resolution and adjudication.
[page=772] N.J.A.C. 13:39-4A.2(i) specifies the responsibilities of the pharmacist-in-charge. The pharmacist-in-charge is responsible for all pharmaceutical functions performed in connection with the remote processing of prescriptions. In addition, the pharmacist-in-charge is responsible for ensuring that medications are not stored at, or dispensed from, a remote location. Additionally, the pharmacist-in-charge is responsible for ensuring that all pharmacists and pharmacy technicians have received adequate training relevant to performing pharmaceutical functions at a remote location and are trained on the pharmacy's policy and procedures manual concerning the remote processing of prescriptions. The pharmacist-in-charge must also make sure that pharmaceutical functions performed by a pharmacy technician at a remote location are reviewed and approved by a New Jersey licensed pharmacist. In addition, the pharmacist-in-charge is responsible for ensuring that the pharmacist or pharmacy technician performing pharmaceutical functions at a remote location has access to the pharmacy's electronic prescription files and that adequate security controls, as described at subsection (k), are in place to ensure the confidentiality of all patient information. The pharmacist-in-charge is also responsible for ensuring that there is a policy and procedures manual with regard to the remote processing of prescriptions that meets the requirements at subsection (j).
N.J.A.C. 13:39-4A.2(j) requires a pharmacy engaging in the remote processing of prescriptions to operate in accordance with the pharmacy's written policy and procedures manual. Paragraph (j)1 sets forth the minimum procedures that must be included in the written policy and procedures manual. The policy and procedures manual must include security controls; work environment for the remote location; responsibilities of the pharmacist-in-charge; and criteria for selecting and training of personnel to engage in the remote processing of prescriptions. In addition, the policy and procedures manual must provide for reporting to the Board within seven days of violations of maintaining patient confidentiality and any incidents of other compliance issues with this subchapter that negatively impact patient safety. The policy and procedures manual must also include methods to ensure that a State-licensed pharmacist reviews and approves all pharmaceutical functions performed at a remote location by a pharmacy technician and that access to patient medical and medication records is limited to authorized personnel.
N.J.A.C. 13:39-4A.2(j)2, 3, and 4 specify the record-retention requirements for the policies and procedures of operation. Specifically, the pharmacy must have methods for ensuring the retention of each change to the policies and procedures of operation for at least two years after it is made. The policy and procedures manual must be reviewed at least annually and updated, if necessary. In addition, each remote location must have a copy of the written policy and procedures manual, and must provide it, upon request, to the Board for review and inspection.
N.J.A.C. 13:39-4A.2(k) provides that the security controls for ensuring the confidentiality of all patient information shall include at least a two-factor positive authentication of the authorized user, encryption of all data exchanged between the equipment located at the remote location and the remote processing pharmacy, and measures designed to prevent unauthorized storage or transfer of patient information. In addition, the security controls must include measures designed to ensure that patient information cannot be captured, copied, downloaded, printed, reproduced, retained, or stored at a remote location.
N.J.A.C. 13:39-4A.2(l) provides that the work environment must be conducive to providing quality patient treatment decisions, private counseling, or other pharmaceutical functions permissible pursuant to the proposed new rules. In particular, the proposed new regulation specifies that an individual engaging in the remote processing of prescriptions out of a home environment is required to perform such work in a designated space and, when performing this work, access to the space must be limited and not actively used as the individual's primary living, household, or family space. Additionally, when not in use, process-related documentation or materials and work equipment must be properly secured. The space used for the remote processing of prescriptions must also be open and accessible for Board inspection.
N.J.A.C. 13:39-4A.2(m) states that a pharmacist and pharmacy technician engaging in the remote processing of prescriptions must comply with all laws, rules, and regulations for ensuring the confidentiality of patient information. Subsection (n) provides that a pharmacy engaging in the remote processing of prescriptions must comply with the audit trail requirements at N.J.A.C. 13:39-7.6.
N.J.A.C. 13:39-4A.2(o) states that the remote location shall be considered part of the pharmacy, and that the remote location and any equipment and/or devices used in connection with the remote processing of prescriptions shall be subject to Board inspection. N.J.A.C. 13:39-4A.2(p) specifies that no medications shall be stored at, or dispensed from, the remote location.
Proposed N.J.A.C. 13:39-4A.3 sets forth the rules governing the remote processing of prescriptions by an out-of-State pharmacy registered with the Board. An out-of-State pharmacy registered with the Board may engage in the remote processing of prescriptions that are shipped, mailed, distributed, or delivered to New Jersey, provided that remote processing is authorized under the pharmacy laws, rules, and regulations in the jurisdiction where the out-of-State pharmacy is located. In addition, the pharmacist or pharmacy technician who engages in the remote processing of prescriptions must be licensed or registered and adequately trained as required by the law of the out-of-State jurisdiction.
The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
Social Impact
The Board believes that the proposed new rules will have a positive social impact on licensees, registrants, and permit holders without having a negative impact on the welfare of the public. The proposed new rules provide pharmacies greater flexibility in managing prescription processing operations, which, as observed during the COVID-19 pandemic, is particularly useful to reduce transmission of communicable diseases. In addition, the proposed new rules help ensure that any prescription processing functions performed at a location other than on the premises of a pharmacy are performed by qualified and appropriately trained individuals pursuant to safeguards designed to protect the confidentiality of prescription and patient information. Additionally, the proposed new rules may have a positive social impact on licensees and registrants to the extent it reduces the need to commute and incur transportation costs.
Economic Impact
The proposed new rules may have an economic impact to the extent that pharmacies that choose to engage in the remote processing of prescriptions may incur costs to establish the required security controls to ensure the confidentiality of all patient information. The costs will vary depending upon the pharmacy's technological systems and capabilities. Permit holders may also incur costs to create, review, and update the policy and procedures manual governing the remote processing of prescriptions. The Board believes that any such costs are outweighed by the interest of protecting public health and safety and in protecting the confidentiality of prescription and patient information.
Federal Standards Statement
Requirements at N.J.A.C. 13:39-4A.2(l) require compliance with all Federal laws, rules, and regulations, including the Federal Health Insurance Portability and Accountability Act of 1996, P.L. 104-191, concerning confidentiality of patient information. There are no other Federal laws or standards applicable to the proposed new rules, which are governed by N.J.S.A. 45:14.
Jobs Impact
The Board does not anticipate that the proposed new rules will result in an increase or decrease in the number of jobs in the State. The proposed new rules provide existing businesses with more flexibility to determine where certain pharmaceutical functions are performed.
Agriculture Industry Impact
The Board does not anticipate that the proposed new rules will have any impact on the agriculture industry in the State.
Regulatory Flexibility Analysis
Currently, the Board licenses approximately 18,800 pharmacists, registers 17,340 pharmacy technicians, and issues permits to approximately 2,248 in-State pharmacies and 1,023 out-of-State [page=773] pharmacies. If Board licensees, registrants, and/or permit holders are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.
For those permit holders, licensees, and pharmacy technicians who participate in the remote processing of prescriptions, the proposed new rules will impose various reporting, recordkeeping, and compliance requirements, as discussed in the Summary above. No additional professional services will be needed to comply with the proposed new rules. The costs of compliance with the proposed new rules are discussed in the Economic Impact above. The Board believes that the proposed new rules should be uniformly applied to all licensees, pharmacy technicians, and permit holders who choose to engage in the remote processing of prescriptions in order to ensure the health, safety, and welfare of the general public in the provision of pharmaceutical services and, therefore, no differing compliance requirements for any licensees, permit holders, or pharmacy technicians are provided based upon the size of the business.
Housing Affordability Impact Analysis
The proposed new rules will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed new rules would evoke a change in the average costs associated with housing because the proposed new rules concern the remote processing of prescriptions.
Smart Growth Development Impact Analysis
The proposed new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed new rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed new rules concern the remote processing of prescriptions.
Racial and Ethnic Community Criminal Justice and Public Safety Impact
The Board has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.
Full text of the proposed new rules follows:
SUBCHAPTER 4A. REMOTE PROCESSING OF PRESCRIPTIONS
13:39-4A.1 Definitions
(a) For purposes of this subchapter, the following words shall have the following meanings, unless the context clearly indicates otherwise:
"Remote location" means a location where the pharmaceutical functions specified in this subchapter are performed, other than on the premises of a pharmacy. The remote location must be located in New Jersey or in another state, territory, or possession of the United States whose regulatory body overseeing the practice of pharmacy is a member of the National Association of Boards of Pharmacy (NABP).
"Remote processing of prescriptions" means the performance of pharmaceutical functions specified in this subchapter at a remote location as defined in this section. "Remote processing of prescriptions" does not:
1. Include the storing or dispensing of any medication; or
2. Involve more than one licensed pharmacy.
13:39-4A.2 Remote processing of prescriptions by a New Jersey pharmacy
(a) A pharmacy may engage in the remote processing of prescriptions, provided that the pharmacy complies with the requirements of this subchapter.
(b) A pharmacy that engages in the remote processing of prescriptions shall notify the Board that it is engaging in the remote processing of prescriptions and shall provide the name of the pharmacist-in-charge who shall be responsible for ensuring and attesting to compliance with the requirements of this subchapter. Such notification shall be made on a form supplied by the Board.
(c) As part of the permit renewal process pursuant to N.J.A.C. 13:39-4.2, a pharmacy engaging in the remote processing of prescriptions, on an annual basis, shall have the permit holder and pharmacist-in-charge attest to compliance with the provisions of this subchapter.
(d) A pharmacy using remote processing of prescriptions shall ensure that:
1. A pharmacist performing pharmaceutical functions at the remote location holds an active New Jersey pharmacist license in good standing;
2. A pharmacy technician performing pharmaceutical functions at the remote location holds an active New Jersey pharmacy technician registration in good standing; and
3. All pharmaceutical functions performed by a pharmacy technician at a remote location are reviewed and approved by a licensed pharmacist.
(e) A pharmacist or pharmacy technician performing pharmaceutical functions for a pharmacy at a remote location shall be an employee of the pharmacy.
(f) A pharmacy engaging in remote processing of prescriptions shall have the following:
1. A written policy and procedures manual maintained pursuant to this section;
2. A certification by the pharmacist-in-charge that all pharmacy technicians performing pharmaceutical functions at a remote location are registered with the Board pursuant to N.J.A.C. 13:39-6.6;
3. The address of the remote location(s) and a description of the work environment consistent with the requirements at (l) below;
4. The security controls to ensure the confidentiality of all patient information consistent with the requirements at (m) below;
5. The names and license or registration numbers of all personnel performing pharmaceutical functions at the remote location(s); and
6. A certification from each person performing pharmaceutical functions at the remote location(s) that the training described at (i)2 and 3 below has been completed.
(g) A pharmacy may allow a pharmacist at a remote location to perform only the following pharmaceutical functions using technology consistent with (k) below:
1. Receipt, interpretation, and clarification of prescription orders received from a prescriber.
i. Prescriptions shall only be in electronic format subject to the security requirements set forth at (k) below. Prescriptions or other health care information shall not be utilized, maintained, or stored in hard copy format at the remote location;
2. Data entry of prescription medication information;
3. Prospective drug utilization review;
4. Refill authorizations;
5. Product verification provided that there is compliance with the restrictions set forth at (p) below;
6. Interventions;
7. Patient counseling;
8. Claims submission; and
9. Claims resolution and adjudication.
(h) A pharmacy may allow a registered pharmacy technician to perform only the following pharmaceutical functions at a remote location using technology consistent with (k) below:
1. Data entry of prescription medication information;
2. Refill authorizations consistent with the requirements at N.J.A.C. 13:39-6.15(a)7;
3. Claims submission; and
4. Claims resolution and adjudication.
(i) The pharmacist-in-charge shall be responsible for all pharmaceutical functions performed in connection with the remote processing of prescriptions. The pharmacist-in-charge shall be responsible, at a minimum, for ensuring that:
1. No medications are stored at, or dispensed from, a remote location;
2. Prior to performing any services in connection with remote processing, all pharmacists and pharmacy technicians engaged in the remote processing of prescriptions have received adequate training relevant to performing pharmaceutical functions at a remote location;
3. Prior to performing any services in connection with remote processing, all pharmacists and pharmacy technicians are trained in the pharmacy's policy and procedures manual with regard to remote processing of prescriptions;
[page=774] 4. All pharmaceutical functions performed by a pharmacy technician at a remote location are reviewed and approved by a New Jersey licensed pharmacist;
5. The pharmacist or pharmacy technician performing pharmaceutical functions at a remote location has access to the pharmacy's electronic prescription files and that adequate security controls as described at (k) below are in place to ensure the confidentiality of all patient information; and
6. There is a policy and procedures manual with regard to the remote processing of prescriptions that meets the requirements at (j) below.
(j) A pharmacy engaging in the remote processing of prescriptions shall operate according to the pharmacy's written policy and procedures manual.
1. The policy and procedures manual shall include, at a minimum, policies and procedures governing the following:
i. Security controls, including measures to ensure that patient information cannot be captured, copied, downloaded, printed, reproduced, retained, or stored at a remote location;
ii. Work environment for the remote location;
iii. Responsibilities of the pharmacist-in-charge;
iv. Reporting to the Board within seven days of the violations of (m) below and any incidents of other compliance issues with this subchapter that negatively impact patient safety;
v. Methods to ensure that a New Jersey licensed pharmacist reviews and approves all pharmaceutical functions performed by a pharmacy technician at a remote location;
vi. Methods to ensure that access to the records of medications and other medical information of the patients maintained by the pharmacy is limited to New Jersey licensed pharmacists or registered pharmacy technicians approved to have access to the records, for the purpose of complying with N.J.A.C. 13:39-7.19;
vii. Criteria for selecting employees to engage in the remote processing of prescriptions; and
viii. Training of all pharmacists and pharmacy technicians engaging in the remote processing of prescriptions.
2. The policy and procedures manual shall set forth methods that shall ensure retention of each amendment, addition, deletion, or other change to the policies and procedures of operation for at least two years after the change is made. Each change shall be signed or initialed by the pharmacist-in-charge and shall include the date on which the pharmacist-in-charge approved the change.
3. The policy and procedures manual shall be reviewed, at least annually, and updated, if necessary.
4. A copy of the written policy and procedures manual adopted pursuant to this section shall be available and immediately accessible at the pharmacy and each remote location. Upon request, the pharmacy shall provide to the Board a copy of the written policy and procedures manual for inspection and review.
(k) Security controls to ensure the confidentiality of all patient information shall include at least a two-factor positive authentication of the authorized user, encryption of all data exchanged between the equipment located at the remote location and the pharmacy, and measures designed to prevent unauthorized storage or transfer of patient information. The security controls must include measures designed to ensure that patient information cannot be captured, copied, downloaded, printed, reproduced, retained, or stored at a remote location.
(l) Remote processing of prescriptions shall be conducted in a work environment that is conducive to providing quality patient treatment decisions, private counseling, or other pharmaceutical functions permissible pursuant to this section. Individuals who engage in the remote processing of prescriptions out of a home environment shall perform the work in a designated space and, when performing this work, access to the space shall be limited and not actively used as their primary living, household, or family space. This space shall be open and accessible for Board inspection. When not in use, process-related documentation or materials and work equipment shall be properly secured.
(m) All pharmacists and pharmacy technicians participating in the remote processing of prescriptions shall ensure the confidentiality of patient information in compliance with all Federal and State laws, rules, and regulations, including the Federal Health Insurance Portability and Accountability Act of 1996, P.L. 104-191.
(n) A pharmacy engaging in the remote processing of prescriptions shall maintain an audit trail that records and documents all pharmaceutical functions performed by a pharmacist or pharmacy technician at a remote location, consistent with the requirements at N.J.A.C. 13:39-7.6.
(o) The remote location shall be considered part of the pharmacy. The remote location and any equipment and/or devices used in connection with the remote processing of prescriptions shall be subject to Board inspection.
(p) No medications shall be stored at, or dispensed from, a remote location.
13:39-4A.3 Remote processing of prescriptions by out-of-State pharmacy
An out-of-State pharmacy registered with the Board pursuant to N.J.A.C. 13:39-4.20 may engage in the remote processing of prescriptions that are to be shipped, mailed, distributed, or delivered to New Jersey, provided that the remote processing of prescriptions is authorized under the pharmacy laws and regulations in the jurisdiction where the out-of-State pharmacy is located, and provided that such functions are performed by a pharmacist or pharmacy technician who is licensed or registered and has been adequately trained, as required by the applicable law of the out-of-State jurisdiction(s).