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NEW JERSEY REGISTER
VOLUME 41, ISSUE 13
ISSUE DATE: JULY 6, 2009
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS

Proposed Amendments: N.J.A.C. 13:45A-27.3, 27.7, 27.8 and 27.9

New Jersey Uniform Prescription Blanks Program
NJPB Required for Prescriptions; Manufacture and Distribution by Approved Vendors; Withdrawal or Termination from NJPB Program; NJPB Printing Specifications; Vendor Requirements

Authorized By: David Szuchman, Director, Division of Consumer Affairs.

Authority: P.L. 2007, c. 244 (N.J.S.A. 45:14-59).

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2009-208.
Submit comments by: September 4, 2009 to:

David Szuchman, Director
New Jersey Division of Consumer Affairs
124 Halsey Street
P.O. Box 45027
Newark, New Jersey 07101

The agency proposal follows:

Summary

The Division of Consumer Affairs is proposing amendments to the rules governing the New Jersey Uniform Prescription Blanks Program at N.J.A.C. 13:45A-27. The rules in N.J.A.C. 13:45A-27 set forth standards for the use of New Jersey Prescription Blanks (NJPBs) by New Jersey licensed prescribers, healthcare facilities and pharmacies, and for the manufacture and distribution of NJPBs by vendors approved by the Division. N.J.S.A. 45:14-59, which requires the Division to establish the format for NJPBs, was amended as part of P.L. 2007, c. 244, to provide that, effective May 23, 2008 , NJPBs for each prescriber and healthcare facility must be numbered consecutively and, if the prescriber or healthcare facility has a National Provider Identifier (NPI), the NPI number must appear on the NJPB.

Consistent with P.L. 2007, c. 244, the Division is proposing to amend the NJPB printing specifications set forth at N.J.A.C. 13:45A-27.8(e) to require that NJPBs be pre-printed with consecutive or serialized numbers. The Division is also proposing to delete N.J.A.C. 13:45A-27.8(k)6, which currently permits NJPBs to be pre-printed with consecutive numbers at the request of a licensed prescriber or healthcare facility, because pre-printed, consecutively numbered or serialized NJPBs will become mandatory upon the effective date of the proposed amendments to N.J.A.C. 13:45A-27.8(e).

The Division is also proposing to amend N.J.A.C. 13:45A-27.8(e) to require that NJPBs be pre-printed with the prescriber or healthcare facility NPI, if the provider or healthcare facility has obtained an NPI number. The NPI was adopted by the Federal government in 2005 as the standard unique identifier that must be used by healthcare providers and facilities that are covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§201 et seq., for health claim reimbursement. Not all healthcare providers are required to obtain a NPI number. Providers and healthcare facilities that have obtained an NPI number, however, will be required to have the NPI number pre-printed on the NJPB upon the effective date of the proposed amendments to N.J.A.C. 13:45A-27.8(e).

Because of the practical difficulties that approved vendors have encountered in processing the significant number of requests for new NJPBs that conform to the new statutory requirements for consecutive numbering and NPI numbers, the Division has advised licensed prescribers and healthcare facilities that, presently, they may comply with the new requirements by writing in or stamping consecutive numbers and the provider or healthcare facility NPI number, if an NPI number has been obtained, onto their NJPBs. Upon the effective date of the proposed [page=2625] amendments to N.J.A.C. 13:45A-27.8(e), however, NJPBs must be pre-printed with consecutive numbers and with the licensed provider or healthcare facility NPI number, if one has been obtained.

In light of these proposed amendments, the Division is also proposing amendments to N.J.A.C. 13:45A-27.3(b), which permits a licensed prescriber affiliated with a licensed healthcare facility to use the NJPB of the licensed facility provided certain information appears on the blank. Specifically, paragraph (b)2 requires the name and license number of the prescriber to be written, typed or stamped to the NJPB. Proposed amendments to paragraph (b)2 will now require the prescriber's NPI number, if he or she has obtained one, to also be written, typed or stamped on the healthcare facility blank.

The Division is also proposing an amendment to N.J.A.C. 13:45A-27.3(e), which currently exempts a prescriber from the requirement to use an NJPB if he or she transmits a verbal or electronic prescription, provided the prescriber provides certain information at the time of transmission. The proposed amendment will require a prescriber to provide his or her NPI number, if one has been obtained, at the time of transmission.

The Division is also proposing an amendment to N.J.A.C. 13:45A-27.7, which provides for the withdrawal or termination of approved vendors from the NJPB program. Subsection (c) currently provides that an approved vendor may be terminated by the Division upon 14 days written notice for any "inability to comply" with the requirements of the subchapter. The Division is proposing to amend subsection (c) to provide that a vendor's approval to participate in the NJPB program may be terminated upon 14 days written notice for any "failure to comply" with the NJPB program requirements, consistent with the requirements currently set forth in subsection (a) of the rule.

The Division is also proposing a technical amendment to N.J.A.C. 13:45A-27.9, concerning vendor requirements, to clarify in paragraph (f)1, that vendors must be capable of producing NJPBs in a single non-erasable and non-reproducible NJPB form. Currently, paragraph (f)1 refers only to a single non-erasable NJPB form. N.J.S.A. 45:14-59, however, provides that such blanks shall be both non-erasable and non-reproducible, and the term NJPB is currently defined in N.J.A.C. 13:45A-27.2 to mean a uniform, non-reproducible, non-erasable safety paper form.

The Division is proposing to amend subsection (h) of N.J.A.C. 13:45A-27.9, which requires vendors to maintain an on-site computerized database of relevant information for licensed prescribers and healthcare facilities, to require the database to also include the provider or healthcare facility NPI number, if one has been obtained by the prescriber or healthcare facility, consistent with the NPI requirement in P.L. 2007, c. 244 and the proposed amendment to N.J.A.C. 13:45A-27.8.

The Division 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 Division believes that the proposed amendments to N.J.A.C. 13:45A-27.8, requiring NJPBs utilized by all licensed prescribers and healthcare facilities in the State to be pre-printed with consecutive numbers will provide an effective mechanism to help combat drug diversion in the State. It will allow stolen prescription blanks to be more readily identified, thus preventing the filling of fraudulent prescriptions. The Division believes that mandatory pre-printing of consecutive numbers and provider or healthcare facility NPI numbers, if applicable, will positively impact prescribers by easing the administrative burden many prescribers currently face by having to write in or ink stamp consecutive numbers and their NPI number on each written prescription they issue.

Economic Impact

The proposed amendments to N.J.A.C. 13:45A-27.8, requiring NJPBs to be pre-printed with consecutive numbers and with the prescriber or healthcare facility NPI number, if the provider or healthcare facility has obtained an NPI number, may have an economic impact upon prescribers and healthcare facilities. Licensed prescribers and healthcare facilities that have unused NJPBs that do not meet the preprinted consecutive numbering and NPI number requirements by the effective date of the proposed amendments will be precluded from using their existing blanks and must order new ones printed in compliance with these requirements.

In addition, the proposed amendment to N.J.A.C. 13:45A-27.9(h) may have an economic impact upon approved vendors to the extent that some vendors may incur costs associated with updating their computerized databases to document the provider or healthcare facility NPI number, if one has been obtained by the prescriber or healthcare facility.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments are governed by P.L. 2007, c. 244, codified as N.J.S.A. 45:14-59, and are not subject to any Federal requirements or standards. The Division notes, however, that the proposed amendment to N.J.A.C. 13:45A-27.8 requiring NPI numbers to be preprinted on all NJPBs for prescribers and healthcare facilities in the State that have obtained NPI numbers will help foster compliance with the Federal NPI standard, set forth in 45 CFR §§162.402 et seq. Federal law requires prescribers and healthcare facilities that are covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§201 et seq., to utilize the NPI number assigned to them for reimbursement purposes.

Jobs Impact

The Division does not believe that the proposed amendments will result in the creation or the loss of jobs in the State.

Agriculture Industry Impact

The Division does not believe that the proposed amendments will have any impact on the agriculture industry of the State.

Regulatory Flexibility Analysis

Currently, the Division licenses approximately 40,000 healthcare practitioners who must utilize NJPBs when writing prescriptions. The Division has contracted with 47 vendors to print NJPBs for licensed prescribers and healthcare facilities in the State. If licensed prescribers and healthcare facilities and approved vendors 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.

The proposed amendments will not impose any reporting requirements upon licensed prescribers, healthcare facilities or approved vendors. The proposed amendments to N.J.A.C. 13:45A-27.8 will impose compliance requirements upon licensed prescribers and healthcare facilities, as well as approved vendors to the extent that the proposed amendments will now require additional information to be imprinted on prescriber and healthcare facility NJPBs. In addition, the proposed amendments to N.J.A.C. 13:45A-27.9 will impose an additional recordkeeping requirement upon approved vendors by requiring the vendor's on-site database to record and maintain the NPI number for licensed prescribers and healthcare facilities that have obtained NPI numbers.

No additional professional services will be needed to comply with the proposed amendments. The costs of compliance with the proposed amendments are discussed in the Economic Impact above. The Division believes that the proposed amendments must be uniformly applied to all licensed prescribers and healthcare facilities and all approved vendors in order to ensure that NJPBs utilized in New Jersey comply with the requirements of P.L. 2007, c. 244. Therefore, no differing compliance requirements for any licensed prescriber, healthcare facility or vendor is provided based upon the size of the business.

Smart Growth Impact

The Division does not believe that the proposed amendments will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The proposed amendments will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed amendments concern the use of NJPBs by licensed prescribers and healthcare facilities.

[page=2626] Smart Growth Development Impact

The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the 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 amendments concern the use of NJPBs by licensed prescribers and healthcare facilities.

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

13:45A-27.3 NJPB required for prescriptions

(a) (No change.)

(b) A licensed prescriber affiliated with a healthcare facility licensed pursuant to P.L. 1971, [c.136] c. 136 (N.J.S.A. 26:2H-1 et seq.), may use the NJPB of the licensed facility provided that:

1. (No change.)

2. The name and license number of the licensed prescriber,and the prescriber's National Provider Identifier (NPI) number, if the prescriber has obtained an NPI number, is legibly written, typed, stamped[,] or otherwise affixed to the NJPB;

3.-4. (No change.)

(c)-(d) (No change.)

(e) A prescription transmitted verbally or transmitted electronically by telephone, facsimile, modem[,] or other means to a pharmacy by a licensed prescriber shall be exempt from the requirement of utilizing an NJPB if the licensed prescriber provides the pharmacist with his or her license number, [and] DEA number, as appropriate to the particular prescription and NPI number, if the prescriber has obtained an NPI number, at the time of transmission of the prescription, and the pharmacist satisfies the requirements of N.J.A.C. 13:39-5.8, 5.8A or 5.8B.

1. (No change.)

(f) (No change.)

13:45A-27.7 Manufacture and distribution by approved vendors; withdrawal or termination from NJPB program

(a)-(b) (No change.)

(c) [An approved] A vendor's approval to participate in the NJPB program may be terminated by the Division upon 14 days written notice for any [inability] failure to comply with the requirements as set forth in this subchapter or the NJPB program specifications. The Division shall provide the vendor with the opportunity to respond in writing to any allegation of [an inability] a failure to comply with NJPB program requirements. A vendor[that] whose approval to participate in the NJPB program is terminated by the Division shall notify, in writing, within seven days of such termination, each licensed prescriber and healthcare facility that ordered NJPBs from the vendor within the previous six months.

(d)-(g) (No change.)

13:45A-27.8 NJPB printing specifications

(a)-(d) (No change.)

(e) The upper portion of the front side of each NJPB shall include [the batch number, and the prescriber or healthcare facility name, the prescriber or healthcare facility address, which may be an address other than the address of record, but which shall not be a post office box, the license, certification or authorization number of the licensed prescriber, or the provider number of the healthcare facility, which shall all be printed in black ink.] the following information, printed in black ink:

1. The batch number;

2. The consecutive or serialized number;

3. The prescriber or healthcare facility name;

4. The prescriber or healthcare facility National Provider Identifier (NPI) number, if the prescriber or healthcare facility has obtained an NPI number;

5. The prescriber or healthcare facility address, which may be an address other than the address of record, but which shall not be a post office box; and

6. The license, certification or authorization number of the licensed prescriber, or the provider number of the healthcare facility.

(f)-(j) (No change.)

(k) At the request of a licensed prescriber or licensed healthcare facility, NJPBs may be pre-printed with the following:

1.-3. (No change.)

4. The statement "NOT VALID FOR CONTROLLED SUBSTANCES" on the face of the NJPB in black ink; and

5. DEA numbers[; and].

[6. Consecutive numbers (serialized).]

(l)-(o) (No change.)

13:45A-27.9 Vendor requirements

(a)-(e) (No change.)

(f) Vendors shall be capable of producing NJPBs in the following forms:

1. A single non-erasable and non-reproducible NJPB form; and

2.-4. (No change.)

(g) (No change.)

(h) Vendors shall maintain an on-site computerized database, which shall:

1. Include the following data fields for each licensed prescriber and healthcare facility:

i.-vi. (No change.)

vii. National Provider Identifier (NPI) number, if the licensed prescriber or healthcare facility has obtained an NPI number;

Recodify existing vii.-ix. as viii.-x. (No change in text.)

2. (No change.)

 
   
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