Montana Administrative Register Notice 37-583 No. 12   06/21/2012    
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In the matter of the amendment of ARM 37.86.1501, 37.86.1502, and 37.86.1506 pertaining to home infusion therapy program revisions







TO:  All Concerned Persons


1.  On April 26, 2012, the Department of Public Health and Human Services published MAR Notice No. 37-583 pertaining to the public hearing on the proposed amendment of the above-stated rules at page 868 of the 2012 Montana Administrative Register, Issue Number 8.


2.  The department has amended ARM 37.86.1502 and 37.86.1506 as proposed.


3.  The department has amended the following rule as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:


            37.86.1501  HOME INFUSION THERAPY SERVICES, DEFINITIONS  In ARM 37.86.1501, 37.86.1502, 37.86.1505, and 37.86.1506, the following definitions apply:

            (1) remains as proposed.

            (2)  "Home infusion therapy services" means a comprehensive treatment program for the preparation and administration of parenteral medications or parenteral nutritional services to a recipient who is not receiving infusion therapy as a hospital inpatient or outpatient.  Home infusion therapy services include all pharmacist professional services, all agency staff services and all associated medical equipment and supplies for care required at home or an ambulatory infusion suite (AIS).  Home infusion therapy services do not include professional physician services or drugs.  Drugs are covered under the pharmacy outpatient program.

            (3)  "Home Nursing Services for Infusion/Specialty Drug Administration" means high-tech registered nurse (RN) services provided by an RN with special education, training and expertise in home administration of drugs via infusion, home/AIS administration of specialty drugs, or home nursing management of disease state and care management programs.  Typical services include:

            (a) through (c) remain as proposed.

            (d)  catheter insertion/maintenance; and

            (e) through (5) remain as proposed.


AUTH:  53-2-201, 53-6-113, MCA

IMP:     53-6-101, 53-6-113, MCA


4.  The department has thoroughly considered the comments and testimony received.  A summary of the comments received and the department's responses are as follows:


COMMENT #1:  A commenter suggested additions to the department's proposed rule language defining "Home Infusion Therapy Services" in ARM 37.86.1501.  They asked that the department consider the inclusion of the word "hospital" and add "for care required at home or an ambulatory infusion suite (AIS)" in the proposed rule.  They also asked that a definition for "Alternate Treatment Site (ATS)" and "Ambulatory Infusion Suite (AIS)" be added.  They proposed an ATS be defined as "a treatment location outside of an institution such as a hospital or nursing home.  This includes a patient's home or an ambulatory infusion suite (AIS) of the home infusion therapy provider."  The commenter's suggested definition of AIS was "a treatment location operated as part of the home infusion therapy providers operations."


RESPONSE #1:  The department appreciates the comment submitted and will include "ambulatory infusion suites" as an authorized place of service in ARM 37.86.1501.  The department appreciates the comment submitted asking to add the word hospital and the definitions for AIS and ATS; however, the department will not be adding that language because the Home Infusion Therapy Provider Manual clearly defines the authorized places of service.


COMMENT #2:  A commenter proposed a change to the language defining "Home Nursing Services for Infusion/Specialty Drug Administration" in ARM 37.86.1501 by including the acronym "AIS." The commenter also asked that the department consider the inclusion of the wording "catheter maintenance" as a typical home infusion therapy nursing service in ARM 37.86.1501.


RESPONSE #2:  The department appreciates the comment submitted and will add the suggested language to ARM 37.86.1501.


COMMENT #3:  A commenter asked for clarification of the proposed rule change in ARM 37.86.1501.  They interpreted the proposed change to mean the following: "A licensed certified home health agency cannot provide infusion services/visits in the home because those services have been consolidated into the Home Infusion Therapy Program.  Therefore, the Home Infusion Therapy Program has to provide all the nursing services in the home."  They also asked if a home infusion therapy provider was allowed to contract out that nursing therapy service/visit to a home health agency if they have the qualified registered nurses on staff, and if so, is this patient a home infusion therapy patient?  Finally, the commenter asked: "If this patient has identified home health skilled needs, may this patient be open to both programs?"


RESPONSE #3:  A licensed, certified Home Health Agency can provide infusion services/visits in the home as well as home nursing services as defined in ARM 37.86.1501.  The home infusion nursing services must be provided by a high-tech registered nurse (RN) who will provide typical services to include evaluation and assessment, education and training for the patient or caregiver, inspection and consultation of aseptic home environment, catheter insertion and maintenance, and patient assessment.  Any services outside the scope of this definition will be considered as skilled nursing services for home health and not covered in the Home Infusion Therapy Program.


            5.  These rule amendments are effective July 1, 2012.


/s/ John Koch                                                 /s/ Mary E. Dalton acting for            

Rule Reviewer                                               Anna Whiting Sorrell, Director

                                                                        Public Health and Human Services


Certified to the Secretary of State June 11, 2012


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