HF 657

1st Engrossment - 89th Legislature (2015 - 2016) Posted on 03/10/2015 07:57am

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; changing
payment rates for certain drugs covered under medical assistance and allowing
retrospective billing for certain facilities; amending Minnesota Statutes 2014,
sections 151.58, subdivisions 2, 5; 256B.0625, subdivisions 13, 13e.

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 boarding care home licensed under sections 144.50 to 144.58 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 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 new text begin , unless the filled cassettes, canisters, or containers have been provided
by a repackager registered with the United States Food and Drug Administration new text end ; 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, as provided under subdivision 13e, paragraph (b) 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.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2016, or upon federal
approval, whichever is later.
new text end

Sec. 4.

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

Subd. 13e.

Payment rates.

(a) The basis for determining the amount of payment
shall be the lower of the actual acquisition costs of the drugs or the maximum allowable
cost by the commissioner plus the fixed dispensing fee; or the usual and customary price
charged to the public. The amount of payment basis must be reduced to reflect all discount
amounts applied to the charge by any provider/insurer agreement or contract for submitted
charges to medical assistance programs. The net submitted charge may not be greater
than the patient liability for the service. The pharmacy dispensing fee shall be $3.65 new text begin
for legend prescription drugs new text end , except that the dispensing fee for intravenous solutions
which must be compounded by the pharmacist shall be $8 per bag, $14 per bag for cancer
chemotherapy products, and $30 per bag for total parenteral nutritional products dispensed
in one liter quantities, or $44 per bag for total parenteral nutritional products dispensed in
quantities greater than one liter. new text begin The pharmacy dispensing fee for over-the-counter drugs
shall be $3.65, except that the fee shall be $....... for retrospectively billing pharmacies
when billing for quantities less than the number of units contained in the manufacturer's
original package. new text end Actual acquisition cost includes quantity and other special discounts
except time and cash discounts. The actual acquisition cost of a drug shall be estimated
by the commissioner at wholesale acquisition cost plus four percent for independently
owned pharmacies located in a designated rural area within Minnesota, and at wholesale
acquisition cost plus two percent for all other pharmacies. A pharmacy is "independently
owned" if it is one of four or fewer pharmacies under the same ownership nationally. A
"designated rural area" means an area defined as a small rural area or isolated rural area
according to the four-category classification of the Rural Urban Commuting Area system
developed for the United States Health Resources and Services Administration. Effective
January 1, 2014, the actual acquisition cost of a drug acquired through the federal 340B
Drug Pricing Program shall be estimated by the commissioner at wholesale acquisition
cost minus 40 percent. Wholesale acquisition cost is defined as the manufacturer's list
price for a drug or biological to wholesalers or direct purchasers in the United States, not
including prompt pay or other discounts, rebates, or reductions in price, for the most
recent month for which information is available, as reported in wholesale price guides or
other publications of drug or biological pricing data. The maximum allowable cost of a
multisource drug may be set by the commissioner and it shall be comparable to, but no
higher than, the maximum amount paid by other third-party payors in this state who have
maximum allowable cost programs. Establishment of the amount of payment for drugs
shall not be subject to the requirements of the Administrative Procedure Act.

(b) new text begin Pharmacies dispensing prescriptions to residents of long-term care facilities
using an automated drug distribution system meeting the requirements of section 151.58,
or a packaging system meeting the packaging standards set forth in Minnesota Rules, part
6800.2700, that govern the return of unused drugs to the pharmacy for reuse, may employ
retrospective billing for prescriptions dispensed to long-term care facility residents. A
retrospectively billing pharmacy must submit a claim only for the quantity of medication
used by the enrolled recipient during the defined billing period. A retrospectively billing
pharmacy must use a billing period not less than one calendar month or 30 days.
new text end

new text begin (c) new text end An additional dispensing fee of $.30 may be added to the dispensing fee paid to
pharmacists for legend drug prescriptions dispensed to residents of long-term care facilities
when a unit dose blister card system, approved by the department, is used. Under this type
of dispensing system, the pharmacist must dispense a 30-day supply of drug. The National
Drug Code (NDC) from the drug container used to fill the blister card must be identified on
the claim to the department. The unit dose blister card containing the drug must meet the
packaging standards set forth in Minnesota Rules, part 6800.2700, that govern the return
of unused drugs to the pharmacy for reuse. deleted text begin The deleted text end new text begin A new text end pharmacy provider new text begin using packaging
that meets the standards set forth in Minnesota Rules, part 6800.2700, subpart 2, new text end will be
required to credit the department for the actual acquisition cost of all unused drugs that are
eligible for reuse new text begin , unless the pharmacy is using retrospective billing new text end . The commissioner
may permit the drug clozapine to be dispensed in a quantity that is less than a 30-day supply.

deleted text begin (c) deleted text end new text begin (d) new text end Whenever a maximum allowable cost has been set for a multisource drug,
payment shall be the lower of the usual and customary price charged to the public or the
maximum allowable cost established by the commissioner unless prior authorization
for the brand name product has been granted according to the criteria established by
the Drug Formulary Committee as required by subdivision 13f, paragraph (a), and the
prescriber has indicated "dispense as written" on the prescription in a manner consistent
with section 151.21, subdivision 2.

deleted text begin (d) deleted text end new text begin (e) new text end The basis for determining the amount of payment for drugs administered in
an outpatient setting shall be the lower of the usual and customary cost submitted by
the provider, 106 percent of the average sales price as determined by the United States
Department of Health and Human Services pursuant to title XVIII, section 1847a of the
federal Social Security Act, the specialty pharmacy rate, or the maximum allowable cost
set by the commissioner. If average sales price is unavailable, the amount of payment
must be lower of the usual and customary cost submitted by the provider, the wholesale
acquisition cost, the specialty pharmacy rate, or the maximum allowable cost set by the
commissioner. Effective January 1, 2014, the commissioner shall discount the payment
rate for drugs obtained through the federal 340B Drug Pricing Program by 20 percent. The
payment for drugs administered in an outpatient setting shall be made to the administering
facility or practitioner. A retail or specialty pharmacy dispensing a drug for administration
in an outpatient setting is not eligible for direct reimbursement.

deleted text begin (e) deleted text end new text begin (f) new text end The commissioner may negotiate lower reimbursement rates for specialty
pharmacy products than the rates specified in paragraph (a). The commissioner may
require individuals enrolled in the health care programs administered by the department
to obtain specialty pharmacy products from providers with whom the commissioner has
negotiated lower reimbursement rates. Specialty pharmacy products are defined as those
used by a small number of recipients or recipients with complex and chronic diseases
that require expensive and challenging drug regimens. Examples of these conditions
include, but are not limited to: multiple sclerosis, HIV/AIDS, transplantation, hepatitis
C, growth hormone deficiency, Crohn's Disease, rheumatoid arthritis, and certain forms
of cancer. Specialty pharmaceutical products include injectable and infusion therapies,
biotechnology drugs, antihemophilic factor products, high-cost therapies, and therapies
that require complex care. The commissioner shall consult with the formulary committee
to develop a list of specialty pharmacy products subject to this paragraph. In consulting
with the formulary committee in developing this list, the commissioner shall take into
consideration the population served by specialty pharmacy products, the current delivery
system and standard of care in the state, and access to care issues. The commissioner shall
have the discretion to adjust the reimbursement rate to prevent access to care issues.

deleted text begin (f) deleted text end new text begin (g) new text end Home infusion therapy services provided by home infusion therapy
pharmacies must be paid at rates according to subdivision 8d.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2016, or upon federal
approval, whichever is later.
new text end