Bill Text: NC H675 | 2013-2014 | Regular Session | Enrolled
Bill Title: Amend Pharmacy Laws
Spectrum: Bipartisan Bill
Status: (Passed) 2013-07-29 - Ch. SL 2013-379 [H675 Detail]
Download: North_Carolina-2013-H675-Enrolled.html
GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2013
HOUSE BILL 675
RATIFIED BILL
AN ACT AMENDING LAWS PERTAINING TO THE REGULATION OF PHARMACY TECHNICIANS, pharmacy audits, and prescriptions for schedule ii substances.
The General Assembly of North Carolina enacts:
SECTION 1. G.S. 90‑85.3 is amended by adding a new subsection to read:
"(q3) "Certified pharmacy technician" means a pharmacy technician who (i) has passed a nationally recognized pharmacy technician certification board examination, or its equivalent, that has been approved by the Board and (ii) obtains and maintains certification from a nationally recognized pharmacy technician certification board that has been approved by the Board."
SECTION 2. G.S. 90‑85.15A reads as rewritten:
"§ 90‑85.15A. Pharmacy technicians.
(a) Registration.Registration,
Generally. – A registration program for pharmacy technicians is established
for the purposes of identifying those persons who are employed or are
eligible for employment as pharmacy technicians. The Board must maintain a
registry of pharmacy technicians that contains the name of each pharmacy
technician, the name and location of the a pharmacy in which the
pharmacy technician works, the pharmacist‑manager who employs the
pharmacy technician, and the dates of that employment.
(a1) Registration
of Noncertified Pharmacy Technicians. – The Board must register a pharmacy
technician who pays the fee required under G.S. 90‑85.24G.S. 90‑85.24,
is employed by a pharmacy holding a valid permit under this Article, and
completes a required training program.program provided by the supervising
pharmacist‑manager as specified in subsection (b) of this section. A
pharmacy technician must register with the Board within 30 days after the date
the pharmacy technician completes a training program conducted provided
by the pharmacy technician's supervising pharmacist‑manager.
The registration must be renewed annually by paying a registration fee.
(a2) Registration of Certified Pharmacy Technicians. – The Board must register a certified pharmacy technician who pays the fee required under G.S. 90‑85.24 and provides proof of current certification. The registration must be renewed annually by paying a registration fee and providing proof of current certification.
(b) Responsibilities of Pharmacist‑Manager.Pharmacist‑Manager
to Noncertified Pharmacy Technicians. – A pharmacist‑manager may hire
a person who has a high school diploma or equivalent or is currently enrolled
in a program that awards a high school diploma or equivalent to work as a
pharmacy technician. Pursuant to G.S. 90‑85.21, a pharmacist‑manager
must notify the Board within 30 21 days of the date the pharmacy
technician began employment. The pharmacist‑manager must provide a
training program for a pharmacy technician that includes pharmacy terminology,
pharmacy calculations, dispensing systems and labeling requirements, pharmacy
laws and regulations, record keeping and documentation, and the proper handling
and storage of medications. The requirements of a training program may differ
depending upon the type of employment. The training program must be provided
and completed within 180 days of the date the pharmacy technician began employment
unless the pharmacy technician is registered with the Board. If the pharmacy
technician is registered with the Board, then the completion of the training
program is optional at the discretion of the pharmacist‑manager.employment.
(b1) Responsibilities of Pharmacist‑Manager to Certified Pharmacy Technicians. – A pharmacist‑manager may hire a certified pharmacy technician who has registered with the Board pursuant to subsection (a2) of this section. Pursuant to G.S. 90‑85.21, a certified pharmacy technician shall notify the Board within 10 days of beginning employment as a pharmacy technician. The supervising pharmacist‑manager and certified pharmacy technician shall be deemed to have satisfied the pharmacy technician training program requirements of subsection (b) of this section.
(c) Supervision. – A
pharmacist may not supervise more than two pharmacy technicians unless the
pharmacist‑manager receives written approval from the Board. The Board
may not allow a pharmacist to supervise more than two pharmacy technicians
unless the additional pharmacy technicians have passed a nationally
recognized pharmacy technician certification board exam, or its equivalent,
that has been approved by the Board.are certified pharmacy technicians.
The Board must respond to a request from a pharmacist‑manager to allow a
pharmacist to supervise more than two pharmacy technicians within 60 days of
the date it received the request. The Board must respond to the request in one
of three ways:
(1) Approval of the request.
(2) Approval of the request as amended by the Board.
(3) Disapproval of the request. A disapproval of a request must include a reasonable explanation of why the request was not approved.
(d) Disciplinary Action. – The Board may, in accordance with Chapter 150B of the General Statutes and rules adopted by the Board, issue a letter of reprimand or suspend, restrict, revoke, or refuse to grant or renew the registration of a pharmacy technician if the pharmacy technician has done one or more of the following:
(1) Made false representations or withheld material information in connection with registering as a pharmacy technician.
(2) Been found guilty of or plead guilty or nolo contendere to a felony involving the use or distribution of drugs.
(3) Indulged in the use of drugs to an extent that it renders the pharmacy technician unfit to assist a pharmacist in preparing and dispensing prescription medications.
(4) Developed a physical or mental disability that renders the pharmacy technician unfit to assist a pharmacist in preparing and dispensing prescription medications.
(4a) Been negligent in assisting a pharmacist in preparing and dispensing prescription medications.
(5) Willfully violatedFailed
to comply with the laws governing pharmacy technicians, including any
provision of this Article Article or rules adopted by the Board
governing pharmacy technicians.
(e) Exemption. – This section does not apply to pharmacy students who are enrolled in a school of pharmacy approved by the Board under G.S. 90‑85.13.
(f) Rule‑Making Authority. – The Board may adopt rules necessary to implement this section."
SECTION 3. G.S. 90‑85.50(b) is amended by adding the following new subdivisions to read:
"(21) Not to be subject to recoupment on any portion of the reimbursement for the dispensed product of a prescription, unless otherwise provided in this subdivision.
a. Recoupment of reimbursement, or a portion of reimbursement, for the dispensed product of a prescription may be had in the following cases:
1. Fraud or other intentional and willful misrepresentation evidenced by a review of the claims data, statements, physical review, or other investigative methods.
2. Dispensing in excess of the benefit design, as established by the plan sponsor.
3. Prescriptions not filled in accordance with the prescriber's order.
4. Actual overpayment to the pharmacy.
b. Recoupment of claims in cases set out in sub-subdivision a. of this subdivision shall be based on the actual financial harm to the entity or the actual underpayment or overpayment. Calculations of overpayments shall not include dispensing fees unless one of the following conditions is present:
1. A prescription was not actually dispensed.
2. The prescriber denied authorization.
3. The prescription dispensed was a medication error by the pharmacy. For purposes of this subdivision, a medication error is a dispensing of the wrong drug or dispensing to the wrong patient or dispensing with the wrong directions.
4. The identified overpayment is based solely on an extra dispensing fee.
5. The pharmacy was noncompliant with Risk Evaluation and Mitigation Strategies (REMS) program guidelines.
6. There was insufficient documentation, including electronically stored information, as described in this subsection.
7. Fraud or other intentional and willful misrepresentation by the pharmacy.
(22) To have an audit based only on information obtained by the entity conducting the audit and not based on any audit report or other information gained from an audit conducted by a different auditing entity. This subdivision does not prohibit an auditing entity from using an earlier audit report prepared by that auditing entity for the same pharmacy. Except as required by State or federal law, an entity conducting an audit may have access to a pharmacy's previous audit report only if the previous report was prepared by that entity.
(23) If the audit is conducted by a vendor or subcontractor, that entity is required to identify the responsible party on whose behalf the audit is being conducted without having this information being requested.
(24) To use any prescription that complies with federal or State laws and regulations at the time of dispensing to validate a claim in connection with a prescription, prescription refill, or a change in a prescription."
SECTION 4. G.S. 90‑85.52 reads as rewritten:
"§ 90‑85.52. Pharmacy audit recoupments.
(a) Recoupments of any
disputed funds shall occur only after The entity conducting an audit
shall not recoup any disputed funds, charges, or other penalties from a
pharmacy until (i) the deadline for initiating the appeals process established
pursuant to G.S. 90‑85.51 has elapsed or (ii) after the final
internal disposition of an audit, including the appeals process as set forth in
G.S. 90‑85.51, whichever is later, unless fraud or
misrepresentation is reasonably suspected.
(b) Recoupment on an audit shall be refunded to the responsible party as contractually agreed upon by the parties.
(c) The entity conducting the audit may charge or assess the responsible party, directly or indirectly, based on amounts recouped if both of the following conditions are met:
(1) The responsible party and the entity conducting the audit have entered into a contract that explicitly states the percentage charge or assessment to the responsible party.
(2) A commission or other payment to an agent or employee of the entity conducting the audit is not based, directly or indirectly, on amounts recouped."
SECTION 5. G.S. 90‑106(a) reads as rewritten:
"(a) Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance included in Schedule II of this Article may be dispensed without the written prescription of a practitioner. No Schedule II substance shall be dispensed pursuant to a written prescription more than six months after the date it was prescribed."
SECTION 6. This act becomes effective October 1, 2013. Sections 2 and 5 apply to acts occurring, and Sections 3 and 4 apply to audits commencing, on or after that date.
In the General Assembly read three times and ratified this the 25th day of July, 2013.
s/ Tom Apodaca
Presiding Officer of the Senate
s/ Thom Tillis
Speaker of the House of Representatives
_____________________________________
Pat McCrory
Governor
Approved __________.m. this ______________ day of ___________________, 2013
