HF 410

as introduced - 86th Legislature (2009 - 2010) Posted on 02/09/2010 01:37am

A bill for an act
relating to health; requiring coverage for plasma protein therapies and home
nursing services; requiring medical assistance coverage of plasma protein
therapies; amending Minnesota Statutes 2008, section 256B.0625, by adding a
subdivision; proposing coding for new law in Minnesota Statutes, chapters 62Q;
151.

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

Section 1.

new text begin [62Q.82] COVERAGE OF PLASMA PROTEIN THERAPIES AND
HOME NURSING SERVICES.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For the purposes of this section, the terms defined in
this subdivision have the meanings given.
new text end

new text begin (b) "Home nursing services" has the meaning given in section 151.58, subdivision 1.
new text end

new text begin (c) "Plasma protein therapy" has the meaning given in section 151.58, subdivision 1.
new text end

new text begin Subd. 2. new text end

new text begin Home treatment. new text end

new text begin Any health plan offered by a health plan company must
provide coverage for home nursing services associated with primary immunodeficiency
diseases, alphal-antitrypsin deficiency, and von Willebrand disease.
new text end

new text begin Subd. 3. new text end

new text begin Drug formulary. new text end

new text begin If a health plan company maintains a drug formulary,
including a formulary relating to specialty pharmaceutical therapies, all FDA-approved
plasma protein therapies shall be included in the formulary.
new text end

new text begin Subd. 4. new text end

new text begin Preauthorization. new text end

new text begin If a health plan company requires preauthorization or
preapproval of a plasma protein therapy before the product can be dispensed, preapproval
or preauthorization shall be completed within 24 hours or one business day, whichever is
later. If the circumstances are deemed urgent by the treating physician, preapproval or
preauthorization shall be administered upon the request of the treating physician.
new text end

new text begin Subd. 5. new text end

new text begin Multiple pharmacies. new text end

new text begin A health plan company shall provide an enrollee
who has been diagnosed with a primary immunodeficiency disease, an alphal-antitrypsin
deficiency, or von Willebrand disease with the option of receiving covered services at
more than one pharmacy that meets the requirements in section 151.58 and the rules
adopted by the board under section 151.58.
new text end

new text begin Subd. 6. new text end

new text begin Medical screening for von Willebrand disease. new text end

new text begin (a) A health plan
company may require a physician to perform a medical screening for von Willebrand
disease and other bleeding disorders before providing coverage for an invasive uterine
surgical procedure for menorrhagia. This requirement must meet the guidelines established
by the National Heart, Lung, and Blood Institute of the National Institutes of Health.
new text end

new text begin (b) A health plan company shall provide coverage for the medical screening required
in paragraph (a), including physician's fees and clinical laboratory services.
new text end

Sec. 2.

new text begin [151.58] PHARMACIES PROVIDING PLASMA PROTEIN THERAPIES.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the terms defined in
this subdivision have the meanings given.
new text end

new text begin (b) "Assay" means the amount of a particular constituent of a mixture or of the
biological or pharmacological potency of a drug.
new text end

new text begin (c) "Ancillary infusion equipment and supplies" means the equipment and supplies
required to infuse a plasma protein therapy into a human vein including, but not limited
to, syringes, needles, sterile gauze, field pads, gloves, alcohol swabs, numbing creams,
tourniquets, medical tape, sharps or equivalent biohazard waste containers, and cold
compression packs.
new text end

new text begin (d) "Plasma protein therapy" means a medicine manufactured from human plasma
or recombinant biotechnology techniques, approved for distribution by the federal Food
and Drug Administration, that is used for the treatment and prevention of symptoms
associated with alpha1-antitrypsin deficiency, primary immunodeficiency diseases, and
von Willebrand disease.
new text end

new text begin (e) "Home nursing services" means specialized nursing care provided in the home
setting to assist a patient in the reconstitution and administration of plasma protein
therapies.
new text end

new text begin (f) "Home use" means infusion or other use of a plasma protein therapy in a place
other than a hemophilia treatment center, hospital, emergency room, physician's office,
outpatient infusion facility, or clinic.
new text end

new text begin (g) "Pharmacy" means a pharmacy that provides patients with plasma protein
therapies and ancillary infusion equipment and supplies.
new text end

new text begin Subd. 2. new text end

new text begin Rules for standards of care. new text end

new text begin The Board of Pharmacy shall promulgate
rules that govern standards of pharmaceutical services for individuals needing plasma
protein therapies. The rules shall include when feasible the standards established by the
medical advisory committees of the patient groups and professional societies representing
individuals with primary immunodeficiency diseases, alphal-antitrypsin deficiency, and
von Willebrand disease. The rules shall include safeguards to ensure the pharmacy
provides:
new text end

new text begin (1) all brands of plasma protein therapies needed by the patients served that are
approved by the federal Food and Drug Administration in all available assays and vial
sizes;
new text end

new text begin (2) the shipment of prescribed plasma protein therapies to the patient within:
new text end

new text begin (i) two business days or less, for established patients once coverage is verified;
new text end

new text begin (ii) three business days or less for new patients in nonemergency situations; and
new text end

new text begin (iii) in cases of emergency, within the time necessary to meet the patient's need;
new text end

new text begin (3) all necessary ancillary infusion equipment and supplies for administration of
plasma protein therapies;
new text end

new text begin (4) coordination of pharmacy services with home nursing services when home
nursing services are deemed necessary by the treating physician;
new text end

new text begin (5) patients who have received plasma protein therapies with a designated contact
telephone number for emergency refills and for reporting problems with a delivery or
product; and
new text end

new text begin (6) patients with notification of recalls and withdrawals of plasma protein therapies
and ancillary infusion equipment within 24 hours of receipt of the notification.
new text end

new text begin Subd. 3. new text end

new text begin Standards for processing prescription orders. new text end

new text begin Notwithstanding section
151.21, a pharmacy shall dispense all prescriptions of plasma protein therapies as written
by the prescribing physician. No changes or substitutions shall be made without prior
approval of the prescribing physician. If the prescription does not indicate a specific brand
name of product, the provider must contact the prescribing physician to determine the
product that should be dispensed.
new text end

new text begin Subd. 4. new text end

new text begin Consent. new text end

new text begin The plasma protein therapy and infusion technique may not be
changed without the consent of the treating physician and the patient.
new text end

Sec. 3.

Minnesota Statutes 2008, section 256B.0625, is amended by adding a
subdivision to read:

new text begin Subd. 53. new text end

new text begin Plasma protein therapies. new text end

new text begin (a) For patients diagnosed with conditions
reliant on plasma protein therapies, medical assistance covers:
new text end

new text begin (1) home delivery of plasma protein therapies and ancillary infusion equipment and
supplies, including emergency deliveries of the therapy when medically necessary;
new text end

new text begin (2) medically necessary ancillary infusion equipment and supplies required to
administer the plasma protein therapies; and
new text end

new text begin (3) in-home assessments conducted by a pharmacist, nurse, or local home health
care agency trained in plasma protein therapies when deemed necessary by the patient's
treating physician.
new text end

new text begin (b) For purposes of this section, "plasma protein therapy" has the meaning given
in section 151.58.
new text end