HF 657

as introduced - 89th Legislature (2015 - 2016) Posted on 02/05/2015 01:58pm

A bill for an act
relating to health; expanding the use of automated drug distribution systems;
modifying the amount of over-the-counter medications covered by medical
assistance if dispensed by an automated drug distribution system; amending
Minnesota Statutes 2014, sections 151.58, subdivisions 2, 5; 256B.0625,
subdivision 13.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2014, section 151.58, subdivision 2, is amended to read:

Subd. 2.

Definitions.

For purposes of this section only, the terms defined in this
subdivision have the meanings given.

(a) "Automated drug distribution system" or "system" means a mechanical system
approved by the board that performs operations or activities, other than compounding or
administration, related to the storage, packaging, or dispensing of drugs, and collects,
controls, and maintains all required transaction information and records.

(b) "Health care facility" means a nursing home licensed under section 144A.02;
a housing with services establishment registered under section 144D.01, subdivision 4,
in which a home provider licensed under chapter 144A is providing centralized storage
of medications; new text begin a board and care home licensed under section 144.56 that is providing
centralized storage of medications; new text end or a Minnesota sex offender program facility operated
by the Department of Human Services.

(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
is responsible for the operation of an automated drug distribution system.

Sec. 2.

Minnesota Statutes 2014, section 151.58, subdivision 5, is amended to read:

Subd. 5.

Operation of automated drug distribution systems.

(a) The managing
pharmacy and the pharmacist in charge are responsible for the operation of an automated
drug distribution system.

(b) Access to an automated drug distribution system must be limited to pharmacy
and nonpharmacy personnel authorized to procure drugs from the system, except that field
service technicians may access a system located in a health care facility for the purposes of
servicing and maintaining it while being monitored either by the managing pharmacy, or a
licensed nurse within the health care facility. In the case of an automated drug distribution
system that is not physically located within a licensed pharmacy, access for the purpose
of procuring drugs shall be limited to licensed nurses. Each person authorized to access
the system must be assigned an individual specific access code. Alternatively, access to
the system may be controlled through the use of biometric identification procedures. A
policy specifying time access parameters, including time-outs, logoffs, and lockouts,
must be in place.

(c) For the purposes of this section only, the requirements of section 151.215 are met
if the following clauses are met:

(1) a pharmacist employed by and working at the managing pharmacy, or at a
pharmacy that is acting as a central services pharmacy for the managing pharmacy,
pursuant to Minnesota Rules, part 6800.4075, must review, interpret, and approve all
prescription drug orders before any drug is distributed from the system to be administered
to a patient. A pharmacy technician may perform data entry of prescription drug orders
provided that a pharmacist certifies the accuracy of the data entry before the drug can be
released from the automated drug distribution system. A pharmacist employed by and
working at the managing pharmacy new text begin , or at a pharmacy under the same ownership as the
managing pharmacy, new text end must certify the accuracy of the filling of any cassettes, canisters, or
other containers that contain drugs that will be loaded into the automated drug distribution
system; and

(2) when the automated drug dispensing system is located and used within the
managing pharmacy, a pharmacist must personally supervise and take responsibility for all
packaging and labeling associated with the use of an automated drug distribution system.

(d) Access to drugs when a pharmacist has not reviewed and approved the
prescription drug order is permitted only when a formal and written decision to allow such
access is issued by the pharmacy and the therapeutics committee or its equivalent. The
committee must specify the patient care circumstances in which such access is allowed,
the drugs that can be accessed, and the staff that are allowed to access the drugs.

(e) In the case of an automated drug distribution system that does not utilize bar
coding in the loading process, the loading of a system located in a health care facility may
be performed by a pharmacy technician, so long as the activity is continuously supervised,
through a two-way audiovisual system by a pharmacist on duty within the managing
pharmacy. In the case of an automated drug distribution system that utilizes bar coding
in the loading process, the loading of a system located in a health care facility may be
performed by a pharmacy technician or a licensed nurse, provided that the managing
pharmacy retains an electronic record of loading activities.

(f) The automated drug distribution system must be under the supervision of a
pharmacist. The pharmacist is not required to be physically present at the site of the
automated drug distribution system if the system is continuously monitored electronically
by the managing pharmacy. A pharmacist on duty within a pharmacy licensed by the
board must be continuously available to address any problems detected by the monitoring
or to answer questions from the staff of the health care facility. The licensed pharmacy
may be the managing pharmacy or a pharmacy which is acting as a central services
pharmacy, pursuant to Minnesota Rules, part 6800.4075, for the managing pharmacy.

Sec. 3.

Minnesota Statutes 2014, section 256B.0625, subdivision 13, is amended to read:

Subd. 13.

Drugs.

(a) Medical assistance covers drugs, except for fertility drugs
when specifically used to enhance fertility, if prescribed by a licensed practitioner and
dispensed by a licensed pharmacist, by a physician enrolled in the medical assistance
program as a dispensing physician, or by a physician, physician assistant, or a nurse
practitioner employed by or under contract with a community health board as defined in
section 145A.02, subdivision 5, for the purposes of communicable disease control.

(b) The dispensed quantity of a prescription drug must not exceed a 34-day supply,
unless authorized by the commissioner.

(c) For the purpose of this subdivision and subdivision 13d, an "active
pharmaceutical ingredient" is defined as a substance that is represented for use in a drug
and when used in the manufacturing, processing, or packaging of a drug becomes an
active ingredient of the drug product. An "excipient" is defined as an inert substance
used as a diluent or vehicle for a drug. The commissioner shall establish a list of active
pharmaceutical ingredients and excipients which are included in the medical assistance
formulary. Medical assistance covers selected active pharmaceutical ingredients and
excipients used in compounded prescriptions when the compounded combination is
specifically approved by the commissioner or when a commercially available product:

(1) is not a therapeutic option for the patient;

(2) does not exist in the same combination of active ingredients in the same strengths
as the compounded prescription; and

(3) cannot be used in place of the active pharmaceutical ingredient in the
compounded prescription.

(d) Medical assistance covers the following over-the-counter drugs when prescribed
by a licensed practitioner or by a licensed pharmacist who meets standards established by
the commissioner, in consultation with the board of pharmacy: antacids, acetaminophen,
family planning products, aspirin, insulin, products for the treatment of lice, vitamins for
adults with documented vitamin deficiencies, vitamins for children under the age of seven
and pregnant or nursing women, and any other over-the-counter drug identified by the
commissioner, in consultation with the formulary committee, as necessary, appropriate,
and cost-effective for the treatment of certain specified chronic diseases, conditions,
or disorders, and this determination shall not be subject to the requirements of chapter
14. A pharmacist may prescribe over-the-counter medications as provided under this
paragraph for purposes of receiving reimbursement under Medicaid. When prescribing
over-the-counter drugs under this paragraph, licensed pharmacists must consult with
the recipient to determine necessity, provide drug counseling, review drug therapy
for potential adverse interactions, and make referrals as needed to other health care
professionals. Over-the-counter medications must be dispensed in a quantity that is the
deleted text begin lower deleted text end new text begin lowest new text end of: (1) the number of dosage units contained in the manufacturer's original
package; deleted text begin and deleted text end (2) the number of dosage units required to complete the patient's course of
therapy new text begin ; or (3) if applicable, the number of dosage units dispensed from a system using
retrospective billing, including, but not limited to, an automated drug dispensing system
as defined in section 151.58 new text end .

(e) Effective January 1, 2006, medical assistance shall not cover drugs that
are coverable under Medicare Part D as defined in the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, Public Law 108-173, section 1860D-2(e),
for individuals eligible for drug coverage as defined in the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, section
1860D-1(a)(3)(A). For these individuals, medical assistance may cover drugs from the
drug classes listed in United States Code, title 42, section 1396r-8(d)(2), subject to this
subdivision and subdivisions 13a to 13g, except that drugs listed in United States Code,
title 42, section 1396r-8(d)(2)(E), shall not be covered.

(f) Medical assistance covers drugs acquired through the federal 340B Drug Pricing
Program and dispensed by 340B covered entities and ambulatory pharmacies under
common ownership of the 340B covered entity. Medical assistance does not cover drugs
acquired through the federal 340B Drug Pricing Program and dispensed by 340B contract
pharmacies.