homeinfusiontherapymanual

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Home Infusion Therapy Services Manual

To print this manual, right click your mouse and choose "print". Printing the manual material found at this website for long-term use is not advisable. Department Policy material is updated periodically and it is the responsibility of the users to check and make sure that the policy they are researching or applying has the correct effective date for their circumstances.

Update Log

Publication History

This publication supersedes all previous Home Infusion Therapy Service
handbooks. Published by the Montana Department of Public Health & Human
Services, June 2004.

Updated May 2008, April 2012, September 2014, January 2016, December 2016, September 2017, January 2020 and July 2021.

Update Log

07/01/2021

The Other Departments section of the Introduction Chapter was revised by removing references to BCBS.

01/01/2020

Cost Share references removed and Cost Share section changed to "Co-Payments section.
Term "Medicaid" replaced with "Montana Healthcare Programs" throughout the manual.
Term "Patient" changed to "Member".

09/26/2017
Home Infusion Therapy Services Manual converted to an HTML format and adapted to 508 Accessibility Standards.

01/06/2017
In summary, The cost share section of the Billing Procedures Chapter was revised and the entire manual was revised to incorporate the initial 508/ADA adaptations agreed upon at the September 2016 Manuals committee meeting including the removal change bars, non-essential pictures, and empty pages. The date on the cover page was also revised.

12/31/2015
Home Infusion Therapy, January 2016, HELP Plan Related Updates and Others

03/02/2015
Home Infusion Therapy, September 2014: Entire Manual

04/13/2012
Home Infusion Therapy, April 2012: Covered Services

End of Update Log Chapter

Key Contacts and Key Websites

Hours for Key Contacts are 8:00 a.m. to 5:00 p.m. Monday through Friday (Mountain Time), unless otherwise stated. The phone numbers designated only “In-state” will not work outside Montana. For additional contacts and websites, see the Contact Us link in the left menu on the Provider Information website.

Key Contacts:

Licensure Bureau

(406) 444-2676 Phone
(406) 444-1742 Fax

Quality Assurance Division
DPHHS
2401 Colonial Drive, 2nd Floor
P.O. Box 202953
Helena, MT 59620-2953

Prior Authorization Unit
For prior authorization requests or for authorization for therapy requests not included in the Medicaid fee schedule:

800-395-7961
406-443-6002 Helena

Mail backup documentation to:

Mountain-Pacific Quality Health
3404 Cooney Drive
Helena, MT 59602

Fax backup documentation to:

800-294-1350
406-513-1928 Helena

Key Websites:

Health Resources Division - https://dphhs.mt.gov/hrd

The Health Resources Division (HRD) administers Medicaid Physician, Acute and Hospital/Clinic healthcare services for low-income and disabled Montanans and oversees the benefits of the Healthy Montana Kids plan. HRD provides administration, policy development, and reimbursement for primary and acute portions of the Medicaid program.

Medicaid Mental Health and Mental Health Services Plan (MHSP) - https://dphhs.mt.gov/bhdd/mentalhealthservices/index

Mental health services information for Medicaid and MHSP.

End of Key Contacts and Key Websites Chapter

Introduction

Thank you for your willingness to serve members of the Montana Healthcare Programs and other medical assistance programs administered by the Department of Public Health and Human Services.

Rule References

Providers must be familiar with all current rules and regulations governing the Montana Healthcare Programs. Provider manuals are to assist providers in billing Montana Healthcare Programs; they do not contain all Montana Healthcare Programs rules and regulations. Rule citations in the text are a reference tool; they are not a summary of the entire rule. In the event that a manual conflicts with a rule, the rule prevails. Links to rules are available on the Provider Information website. Paper copies of rules are available through the Secretary of State’s office. See the Contact Us link in the left menu on the Provider Information website.

Providers are responsible for knowing and following current Montana Healthcare Programs rules and regulations.

In addition to the general Montana Healthcare Programs rules outlined in the General Information for Providers manual, the following rules and regulations are also applicable to the home infusion therapy program:

Code of Federal Regulations (CFR)
- 42 CFR 440.70
Social Security Act (USC)
- 42 USC 1396r – 8(G)
Montana Codes Annotated (MCA)
- MCA 50-5-101 – 50-5-213, 17-6-103
Administrative Rules of Montana (ARM)
- ARM 37.86.1501 – 37.86.1506 Home Infusion Therapy
- ARM 37.106.2401 – 2433 Home Infusion Therapy Agency

Claims Review (MCA 53-6-111, ARM 37.85.406)

The Department is committed to paying Montana Healthcare Programs providers’ claims as quickly as possible. Montana Healthcare Programs claims are electronically processed and usually are not reviewed by medical experts prior to payment to determine if the services provided were appropriately billed. Although the computerized system can detect and deny some erroneous claims, there are many erroneous claims that it cannot detect. For this reason, payment of a claim does not mean that the service was correctly billed or the payment made to the provider was correct. The Department performs periodic retrospective reviews, which may lead to the discovery of incorrect billing or incorrect payment. If a claim is paid and the Department later discovers that the service was incorrectly billed or paid or the claim was erroneous in some other way, the Department is required by federal regulation to recover any overpayment, regardless of whether the incorrect payment was the result of Department or provider error or other cause.

Manual Organization

This manual provides information specifically for providers of home infusion therapy services. Additional essential information for providers is in the separate General Information for Providers manual. Providers are responsible for reviewing both manuals.

A table of contents and an index allow you to quickly find answers to most questions. For a list of key contacts and key websites, see the previous chapter and the Contact Us link in the left menu on the Provider Information website. The margins contain important notes with extra space for writing notes. There is also space on the inside of the front cover to record your National Provider Identifier (NPI) for quick reference when calling Provider Relations.

Manual Maintenance

In order to remain accurate, manuals must be kept current. Changes to manuals are provided through provider notices and replacement pages, which are posted on the Provider Information website. When replacing a page in a paper manual, file the old pages and provider notices in the back of the manual for use with claims that originated under the old policy.

Getting Questions Answered

The provider manuals are designed to answer most questions; however, questions may arise that require a call to a specific group (such as a prior authorization contractor or Provider Relations). For a list of key contacts and key websites, see the previous chapter and the Contact Us link in the left menu on the Provider Information website. Montana Healthcare Programs manuals, provider notices, replacement pages, fee schedules, forms, and more are available on the Provider Information website.

Other Department Programs

The Montana Healthcare Programs home infusion services in this manual are not benefits of the Mental Health Services Plan (MHSP), so the information in this manual does not apply to the MSHP program. For more information on the MHSP program, see the mental health manual available on the Provider Information website.

End of Introduction Chapter

Covered Services

General Coverage Principles

This chapter provides covered services information that applies specifically to services provided by home infusion therapy providers. Like all healthcare services received by Montana Healthcare Programs members, services rendered by these providers must also meet the general requirements listed in the General Information for Providers manual, Provider Requirements chapter.

Home infusion therapy is a comprehensive treatment program of pharmaceutical products and clinical support services provided to members who are living in their home, a nursing facility, or any setting other than a hospital. A physician’s authorization (prescription) for home infusion therapy allows Montana Healthcare Programs members to avoid or leave the hospital care setting and receive medical care at home. Under the guidance of the member’s physician, the licensed home infusion therapy provider develops and implements a treatment program to meet the particular requirements of the member.

Services within Scope of Practice (ARM 37.85.401)
Services are covered only when they are within the scope of the provider’s license.

Licensing (ARM 37.86.1502 and ARM 37.85.402)
Home infusion therapy providers must be licensed under Montana’s healthcare service licensing laws. To obtain licensing requirements and procedures, contact the DPHHS Health Care Facility Licensure Bureau. (See Key Contacts.) A provider must be enrolled with Montana Healthcare Programs as a home infusion therapy provider. Providers who are also providing pharmacy services must enroll with Montana Healthcare Programs as a pharmacy provider.

Services for Children (ARM 37.86.2201–2235)
The Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services program is a comprehensive approach to healthcare for Montana Healthcare Programs members ages 20 and under. It is designed to prevent, identify, and then treat health problems before they become disabling. Under EPSDT, Montana Healthcare Programs eligible children may receive any medically necessary covered service, including all home infusion therapy services described in this manual. All applicable Passport to Health and prior authorization requirements apply.

Non-Covered Services (ARM 37.85.207)

The Department determines which therapies are allowed as home infusion therapy services in consultation with the Department's Drug Use Review Board.

Montana Healthcare Programs does not cover the following services:

Medications which can be appropriately administered orally, through intramuscular or subcutaneous injection, or through inhalation;
Drug products that are not FDA-approved or whose use in the non-hospital setting present an unreasonable health risk to the member; or
Services provided to Montana Healthcare Programs members who are absent from the state, with the following exceptions:
- Medical emergency.
- Required medical services are not available in Montana. Prior authorization may be required. See the Passport to Health manual.
- If the Department has determined that the general practice for members in a particular area of Montana is to use providers in another state.
- When out-of-state medical services and all related expenses are less costly than in-state services.
- When Montana makes adoption assistance or foster care maintenance payments for a member who is a child residing in another state.

Verifying Coverage
The easiest way to verify coverage for a specific service is to check the Department’s fee schedule for your provider type. In addition to being listed on the fee schedule, all services provided must also meet the coverage criteria listed in this chapter and in the Provider Requirements chapter of the General Information for Providers manual. Use the fee schedule in conjunction with the detailed coding descriptions listed in the CPT and HCPCS diagnosis coding books. Use the fee schedule and coding books that pertain to the date of service.

Fee schedules are available on the Provider Information website.

Items Included in the Montana Healthcare Programs Rate

The following products and services are included in Montana Healthcare Programs’s per diem rate for home infusion therapy services. These items may not be billed separately to Montana Healthcare Programs. Each per diem represents a 24-hour period.

All business, overhead, and operational expenses.
Home infusion therapy agency staff service.
- Case management activities including coordination of treatment with other healthcare providers.
- Coordination of benefits, care, and services.
- Development of member assessment and member education materials.
- Development and monitoring of nursing care plans.
- Coordination of education, training, and competency of field nursing staff (or sub-contracted agencies).
- Comprehensive 24/7 delivery and pick-up services. Includes 24/7 availability of a dedicated infusion team consisting of pharmacists, nurses, and all other medical professionals responsible for clinical response, problem solving, troubleshooting, question answering, and other professional duties.
- Any other services provided by the agency staff related to the member’s home infusion.
- Infusion therapy equipment and supplies including, but not limited to, the following:
  - Infusion therapy administration devices (e.g., durable, reusable infusion pumps and elastomeric, disposable infusion pumps).
  - Needles, gauze, sterile tubing, catheters, dressing kits, and other supplies necessary for the safe and effective administration of infusion therapy.
  - Infusion access devices both short peripheral vascular devices and subcutaneous access devices, excluding peripherally inserted central catheter (PICC) lines, midlines, and other centrally placed lines.
  - Other applicable supply expenses.
  - Pharmacist professional services.
  - Development and implementation of pharmaceutical care plans.
  - Coordination of care with physicians, nurses, members, member’s family, other providers, and other caregivers.
  - Member/caregiver education.
  - Sterile procedures, including preparation and compounding of infusion medications, clean room upkeep, vertical and horizontal laminar flow hood certification and all other biomedical procedures necessary for a safe environment.
  - Initial and ongoing member assessment and clinical monitoring to include but not limited to:
    - Medication and dosage changes based upon clinical findings.
    - Pharmacokinetic dosing.
    - Monitoring of potential drug interactions.
    - Medication profile setup.
    - Recommend appropriate laboratory monitoring.
    - Review and interpretation of laboratory values and therapy progression and reporting clinical information to the member’s physician and other healthcare providers.
  - 24/7 call status.

Coverage of Specific Services

The Montana Healthcare Programs Home Infusion Therapy program covers all of the drugs used in covered therapies as described in this section. All covered drugs shall be used within the FDA-approval or standard of practice. Any drug outside of these areas may require literature support and Drug Use Review (DUR) Board review. For requests not found here, contact the Prior Authorization Unit. (See Key Contacts.)

Professional physician and nursing services provided in the physician’s office are to be billed to Montana Healthcare Programs by those providers, not the home infusion therapy provider. Nursing services provided by licensed nurses employed by the home infusion therapy agency will be reimbursed to the agency as specified in the home infusion therapy fee schedule. Home nursing services for infusion/specialty drug administration are not billable when the home infusion therapy program is provided in a skilled nursing facility.

The following table lists home infusion therapy covered services, criteria, and whether the service requires prior authorization. (See the Prior Authorization chapter in this manual.) All covered drugs, solutions, or durable medical equipment (DME) which are not included in the per diem are billed separately by the pharmacy or DME provider unless otherwise stated.

Home Infusion Therapy Covered Services

Service: Alpha 1 proteinase inhibitor
Criteria: Treatment of congenital alpha-1 antitrypsin deficiency. Infusion pump is always required.
Y

Service: Anticoagulant therapy
Criteria: Continuous anticoagulant infusion therapy (e.g., heparin). Low molecular weight heparin is not covered as an infusion therapy.
Prior Authorization: Y

Service: Antiemetic therapy
Criteria: Intermittent or continuous IV infusion of antiemetic therapy that prevents or alleviates intractable nausea and vomiting.
Prior Authorization: Y

Service: Anti-infective therapy
Criteria: Intravenous administration of antibacterial, antiviral or antifungal medications appropriately constituted and admixed with an IV solution. Treatment normally requires an infusion pump, especially if more than one anti-infective is being infused or if prescribed for a pediatric member.
Prior Authorization: Y

Service: Antispasmodic therapy
Criteria: Infusion of antispasmodic agents, which prevents or alleviates muscle spasms. Typically this requires an infusion pump.
Prior Authorization: Y

Service: Anti-tumor necrosis factor
Criteria: Infusion of anti-tumor necrosis factor-alpha for an FDA-approved use. Typically this therapy requires an infusion pump.
Prior Authorization: Y

Service: Catheter care
Criteria: Occasionally a member will require care of a catheter other than simple flushing supplies, which the member shall complete independently. Covered catheter care shall include catheter declotting and catheter repair supply kit. Simple maintenance flushing of a catheter shall not be routinely covered under a per diem procedure; extenuating circumstances may be
negotiated with the Prior Authorization Unit.
Prior Authorization: N

Service: Chelation (desferal therapy)
Criteria: Therapy that is used parenterally to reduce the iron stored in the body in members with hemochromatosis, acute iron poisoning, or abnormal storage of iron due to multiple blood transfusions.
Prior Authorization: Y

Service: Chemotherapy
Criteria:

Antineoplastic/cytotoxic agents. Any agent that destroys or prevents the development, growth or proliferation of malignant cells. This group of compounds is most often used in cancer chemotherapy.
Other drugs used for the treatment of a cancer diagnosis must meet one of the following criteria in order to be presented for review by the DUR Board:
- The drug must be FDA-approved for the diagnosis.
- The drug must be standard of practice for treatment of the diagnosis.
Parenteral administration of antineoplastic medications appropriately reconstituted and possibly admixed with an IV solution and requiring cytotoxic precautions in preparation, administration, and disposal of supplies.
Often requires an infusion pump or specialized delivery system.
Continuous administration is defined as that which occurs without interruption over a period of 24 hours or more. Intermittent administration is for chemotherapy administered for a period of less than 24 hours.

Prior Authorization: Y

Service: Corticosteroid therapy
Criteria: Anti-inflammatory treatment with various steroid hormones used to control acute or chronic symptoms such as those of multiple sclerosis.
Prior Authorization: N

Service: Epoprostenol therapy
Criteria: Intravenous administration of epoprostenol therapy for the treatment of pulmonary hypertension. Always requires an infusion pump.
Prior Authorization: N

Service: Hydration
Criteria:

Parenteral administration of combinations of dextrose or its derivative and/or saline solution, or lactated ringer’s solution and possibly electrolytes to correct or prevent dehydration.
Treatment may require an infusion pump.

Prior Authorization: N

Service: Immunomodulating agents
Criteria: Treatment involving the modification of the functioning of the immune system by the action of a substance that increases or reduces the ability to produce antibodies.
Prior Authorization: Y

Service: Inotropic agents
Criteria:

Intravenous administration of sympathomimetic/inotropic (e.g., dobutamine) medications to improve cardiac performance.
Therapy requires the use of an infusion pump due to the potential for adverse cardiac effects.

Prior Authorization: Y

Service: Pain management
Criteria:

Intravenous or subcutaneous administration of narcotic analgesics admixed in IV solutions with individualized dosage units and delivery systems per member-specific needs.
Always requires an infusion pump.
The fee applies regardless of the method of delivery or the number of cassettes used per week.

Prior Authorization: Y

Service: Tocolytic therapy (preterm labor prevention)
Criteria: Subcutaneous or intravenous administration of tocolytic drugs for prevention and control of preterm uterine contractions.
Prior Authorization: N

Service: Total parenteral nutrition (TPN)
Criteria:

Providing complete nutritional requirements intravenously by carefully controlling the composition of fluid given with respect to total calories derived from protein hydrolysate and dextrose, as well as fats, electrolytes, minerals, and vitamins.
Any IV solution including amino acids and one or more non-protein sources of calories plus electrolytes, minerals, vitamins, insulin, or other medications for a member who is unable to take or absorb food orally. Always requires an infusion pump.
The basic parenteral nutrition solution containing standard TPN elements as defined below are included in the per diem rate:
- Non-specialty amino acids
- Concentrated dextrose solutions
- Sterile water
- Electrolytes (e.g., CaCl2, KCL, KPO4, MgSo4, NaAc, NaCl, NaPO4)
- Standard multi-trace element solutions
- Standard multivitamin solutions
- Insulin
Not included in the TPN per diem are the following items to be coded separately:
- Specialty amino acids for renal failure; hepatic failure; high-stress conditions; with concentrations of 15% or more when medically necessary for fluid restricted members
- Lipids
- Added trace elements not from a standard multi-trace solution
- Added vitamins not from a standard multivitamin solution
- Products serving non-nutritional purposes (e.g., other drugs, heparin, H2 antagonists)

Prior Authorization: Y

Service: Other infusion therapies
Criteria: Anticipating that new infusion therapies will be developed or that a current therapy has been overlooked, the Department will consider authorization of other therapies on an individual basis. These special requests may require literature documentation, peer review, and review by the DUR Board. In addition, the request will require cost information for setting a per diem rate. Contact the Prior Authorization Unit. (See Key Contacts.)
Prior Authorization: Y

End of Covered Services Chapter

Prior Authorization

Prior Authorization Requirements

Many services require prior authorization before they may be provided. These requirements have been established after consultation with the Department’s DUR Board. Criteria listed for each therapy are derived from reviews completed by the University of Montana’s School of Pharmacy and approved by the DUR Board. Prior Authorization requests are reviewed for medical necessity. When seeking prior authorization, keep in mind the following:

Prior Authorization for Retroactively Eligible Members

When submitting claims for retroactively eligible members in which the date of service is more than 12 months earlier than the date the claim is submitted, attach a copy of the Provider Notice of Eligibility (Form 160-M). To obtain Form 160-M the provider needs to contact the member’s local Office of Public Assistance and request the form. For a list of local Offices of Public Assistance, see the DPHHS website, https://dphhs.mt.gov/hcsd/OfficeofPublicAssistance.

Prior Authorization Criteria for Specific Services

Service: Alpha 1 proteinase inhibitor (Prolastin)
Criteria: Alpha 1 antitrypsin deficiency must be documented via laboratory information.

Service: Anticoagulant therapy
Criteria:

Member must not be a candidate for low molecular weight heparin therapy, either due to therapy failure, member status, or diagnosis.
A plan for oral therapy must be submitted, if appropriate.

Service: Antiemetic therapy
Criteria: Member must have failed all other forms of antiemetic therapy including oral, rectal, and intermittent subcutaneous injection.

Service: Anti-infective therapy (antibiotics/antifungals/antivirals)
Criteria:

IV antibiotic therapy for two weeks or less will be authorized upon request.
IV antibiotic therapy for more than two weeks will be considered on an individual basis depending on diagnosis and member condition.
IV antibiotic therapy using IV fluoroquinolones or metronidazole has not been found to have any therapeutic advantage over oral therapies and also requires prior authorization.

Service: Antispasmodic therapy
Criteria: Member must have failed oral forms of antispasmodic therapy.

Service: Anti-tumor necrosis factor (Remicaid)
Criteria: The indication must be FDA-approved or have good published studies supporting the indication for use.

Service: Chemotherapy
Criteria:

The indication must be FDA-approved or have good published studies supporting the indication for use.
The drugs must not be considered vesicants, which cause severe local necrosis (tissue damage) and should not be given in the home; extravasation (leaking out of the vein into local tissue) needs to be recognized and treated immediately. Too dangerous a side-effect for the home administration.

Service: Chelation (desferal therapy)
Criteria: Documentation of hemochromatosis, acute iron poisoning, or abnormal storage of iron due to multiple blood transfusions.

Service: Immunomodulating agents
Criteria:

Prior authorization is required for the use of any intravenous immunoglobulin (IVIG) products.
Must be a diagnosis of one of the following:
- Primary immunodeficiency disorders with a history of recurrent infections
- Idiopathic thrombocytopenic purpura (ITP):
  - Children with newly diagnosed ITP who are not a risk for serious hemorrhage
  - Chronic ITP
  - Adult-onset ITP in those members who do not respond to initial corticosteroid therapy
- Allogeneic bone marrow transplantation
- Symptomatic pediatric HIV infection and CD4 lymphocyte count greater than 200
- Chronic lymphocytic leukemia with a history of at least one serious bacterial infection
- Guillain-Barre syndrome
- Kawasaki syndrome

Service: Inotropic agents (dobutamine therapy)
Criteria: Must be a diagnosis of chronic refractory CHF which meets these criteria:

Member shows no clinical improvement (FC-III or FC-IV) despite treatment with maximum or near-maximum tolerated doses of standard oral therapy for CHF (unless allergic or intolerant).
Member is clinically stable on the dosage to be administered at home prior to discharge from the hospital.
Member demonstrates either an improvement in FC from IV to III or an improvement in symptoms (less dyspnea, improved diuresis, improved renal function, and/or reduction in weight) and hemodynamic parameters (at least 20 percent increase in cardiac output, decreased pulmonary artery pressure, and/or a decrease in pulmonary capillary wedge pressure, measured invasively within six months prior to the initiation of therapy).
Member demonstrates a clinical dependence on the inotrope as evidenced by deterioration in clinical status when the drug is tapered or discontinued.

Service: Pain management
Criteria:

All other forms of pain therapy must have failed, including but not limited to oral, sublingual, rectal, or topical.
The member must not be a candidate for or member of hospice services.

Service: Total parenteral nutrition (TPN)
Criteria:

Recertification is required at 3 months, 9 months, and 24 months after the initiation of therapy. After 2 years, authorization will be determined on a case-by-case basis. If, at any time, there is a break in service to the member of two consecutive months, the entire review process will begin again.
Members must meet the following criteria:
- A member must be unable to meet nutrient requirements via the GI tract safely and adequately. Adequate nutrition cannot be completely possible by dietary adjustment, oral supplements, or tube enteral nutrition.
- The member’s GI tract must be severely diseased, preventing absorption of adequate nutrients to maintain weight and strength consistent with the member’s overall status. TPN must be necessary to sustain the member’s life. Examples of conditions and/or functional impairments that may qualify for coverage include, but are not limited to:
  - Massive small bowel resection
  - Crohn’s disease
  - Sprue disease
  - Short bowel syndrome
  - Radiation enteritis
  - Malabsorption documented by a physician
  - GI tract mechanical obstruction
  - A total caloric intake of 20–35 kcal/kg (of ideal body weight)/day constitutes nutritional dependence.
- Peripheral parenteral nutrition may be used in selected members to provide partial or total nutrition support for up to 2 weeks in members who cannot ingest or absorb adequate oral or enteral tube-delivered nutrients, or when central-vein parenteral nutrition is not feasible.
- The member should not have pulmonary edema, congestive heart failure (New York Heart Association Functional Class 3 or 4), or any other medical condition that would increase the risk of home administration.
- Central-vein parenteral nutrition support, including support via a PICC line, is provided when parenteral feeding is indicated for longer than 2 weeks, peripheral venous access is limited, or nutrient needs are large or fluid restriction is required.

Service: Other therapies
Criteria: Anticipating that new infusion therapies will be developed or that a current therapy has been overlooked, the Department will consider authorization of other therapies on an individual basis. These special requests may require literature documentation, peer review, as well as review by the DUR Board. In addition, the request will require cost information for setting a per diem rate. Contact the Prior Authorization Unit. See Key Contacts.

End of Prior Authorization Chapter

Coordination of Benefits

When Members Have Other Coverage

Montana Healthcare Programs members often have coverage through Medicare, workers’ compensation, employment-based coverage, individually purchased coverage, etc. Coordination of benefits is the process of determining which source of coverage is the primary payer in a particular situation. In general, providers should bill other carriers before billing Montana Healthcare Programs, but there are some exceptions. (See Exceptions to Billing Third Party First in the General Information for Providers manual.) Please note that Medicare is processed differently than other sources of coverage. For additional information on what to do when a member has TPL, see the section titled When a Member Has TPL (ARM 37.85.407) in the General Information for Providers manual.

When a Member Has Medicare

Medicare claims are processed and paid differently than other non-Montana Healthcare Programs claims. The other sources of coverage are called third party liability (TPL), but Medicare is not.

Medicare Part B Crossover Claims
Home infusion therapy services may be covered under Medicare Part B. The Department has an agreement with the Medicare Part B carriers for Montana (Noridian) and the Durable Medical Equipment Regional Carrier (DMERC) under which the carriers provide the Department with a magnetic tape of CMS-1500 claims for members who have both Medicare and Montana Healthcare Programs coverage. Providers must tell Medicare that they want their claims sent to Montana Healthcare Programs automatically and must have their Medicare provider number on file with Montana Healthcare Programs.

When members have both Medicare and Montana Healthcare Programs covered claims, and have made arrangements with Medicare and Montana Healthcare Programs, Part B services need not be submitted to Montana Healthcare Programs. When a crossover claim is submitted only to Medicare, Medicare will process the claim, submit it to Montana Healthcare Programs, and send the provider an Explanation of Medicare Benefits (EOMB). Providers must check the EOMB for the statement indicating that the claim has been referred to Montana Healthcare Programs for further processing. It is the provider’s responsibility to follow up on crossover claims and make sure they are correctly billed to Montana Healthcare Programs within the timely filing limit. (See the Billing Procedures chapter in the General Information for Providers manual.)

Submit Medicare Part B crossover claims to Montana Healthcare Programs only when necessary.

Providers should submit Medicare crossover claims to Montana Healthcare Programs only when:

The referral to Montana Healthcare Programs statement is missing. In this case, submit a claim and a copy of the Medicare EOMB to Montana Healthcare Programs for processing.
The referral to Montana Healthcare Programs statement is present, but you do not hear from Montana Healthcare Programs within 45 days of receiving the Medicare EOMB. Submit a claim and a copy of the Medicare EOMB to Montana Healthcare Programs for processing.
Medicare denies the claim, you may submit the claim to Montana Healthcare Programs with the EOMB and denial explanation (as long as the claim has not automatically crossed over from Medicare).

All Part B crossover claims submitted to Montana Healthcare Programs before the 45-day Medicare response time will be returned to the provider.

When submitting electronic claims with paper attachments, see the Billing Electronically with Paper Attachments section of the Billing Procedures chapter in the General Information for Providers manual.

When submitting a claim with the Medicare EOMB, use Montana Healthcare Programs billing instructions and codes. Medicare’s instructions, codes, and modifiers may not be the same as Montana Healthcare Programs’s. The claim must also include the NPI and Montana Healthcare Programs member ID number. It is the provider’s responsibility to follow-up on crossover claims and make sure they are correctly billed to Montana Healthcare Programs within the timely filing limit. (See the Billing Procedures chapter in the General Information for Providers manual.)

End of Coordination of Benefits Chapter

Billing Procedures

Claim Forms

Services provided by the healthcare professionals covered in this manual must be billed either electronically or on a CMS-1500 claim form. CMS-1500 forms are available from various publishing companies; they are not available from the Department or Provider Relations.

Member Co-Payment (ARM 37.85.204)

Effective for all claims paid on or after January 1, 2020 copayment will not be assessed.

Coding Tips

Standard use of medical coding conventions is required when billing Montana Healthcare Programs. Provider Relations or the Department cannot suggest specific codes to be used in billing for services. The following suggestions may help reduce coding errors and unnecessary claim denials:

Use the correct CPT, HCPCS, and ICD diagnosis coding books.
Always read the complete description and guidelines in the coding books. Relying on short descriptions can result in inappropriate billing.
Attend classes on coding offered by certified coding specialists.
Use the correct units measurement on the claim. See Per Diem Rates and Units in this chapter.

Using the Montana Healthcare Programs Fee Schedule

When billing Montana Healthcare Programs, it is important to use the Department’s fee schedule for your provider type in conjunction with the detailed coding descriptions listed in the CPT and HCPCS coding books. In addition to covered services and payment rates, fee schedules often contain helpful information such as appropriate modifiers and prior authorization indicators. Fee schedules are available on the Provider Information website.

Using Modifiers

Review the guidelines for using modifiers in the CPT, HCPCS, or other helpful resource.
Always read the complete description for each modifier; some modifiers are described in the CPT manual while others are in the HCPCS book.
The Montana Healthcare Programs claims processing system recognizes three pricing modifiers and one informational modifier per claim line. Providers are asked to place any modifiers that affect pricing in the first two modifier fields.
Modifiers SH and SJ must be used when billing for multiple concurrent therapies. The per diem rate of multiple concurrent therapies are discounted 20% off the per diem rate for the second concurrently administered therapy and 25% for the third or more concurrently administered therapy. The discounts may be applied to the lower cost therapy.
Use modifier SH for the second concurrently administered therapy.
Use SJ for the third or more concurrently administered therapy.
Use SS to indicate when home infusion services are provided in the infusion suite of the IV therapy provider.

Per Diem Rate and Units

The term “per diem” represents each day that a member is provided access to a prescribed therapy, beginning the day therapy is initiated and ending with the day the therapy is permanently discontinued. Each day represents a 24-hour period. The expected course and duration of therapy is determined by the plan of care as prescribed by the ordering physician with pharmacist evaluation.

The number of units billed represents a 24-hour period. When a prescription is written in a number of doses, per diem units are calculated by dividing the total prescribed doses by the daily dosing schedule rounded up to the nearest day.

When dosing is given less frequently than every 24 hours (e.g., 48 or 72 hours), the per diem unit count starts with dose 1 and ends with the last dose counting only days in which the therapy was provided.

Billing Tips for Specific Providers

Home Health Agency
Nursing services provided by a Montana Healthcare Programs-enrolled home health agency must be billed by that agency and not by the home infusion therapy provider. Nursing services are billed in accordance with home health program procedures. (See the Home Health provider type page on the website.)

Home Infusion Therapy Agency
Nursing services provided by licensed nurses employed by the home infusion therapy agency will be reimbursed to the agency as specified in the home infusion therapy fee schedule. Home nursing services for infusion/specialty drug administration are not billable when the home infusion therapy program is provided in a skilled nursing facility.

Agencies must use the following codes for billing Montana Healthcare Programs for home infusion therapy services provided by a registered nurse employed by the agency. Passport provider approval is required for these services. See the Passport to Health manual on the Passport to Health page and applicable provider type pages on the Provider Information website.

Home Infusion Therapy Nursing Codes

Code: 99601 Description: Home infusion, specialty drug administration, per visit up to 2 hours

Code: 99602 Description: Home infusion, specialty drug administration, each additional hour

Providers are responsible for maintaining documentation to support all nursing services billed. The Quality Assurance Division periodically verifies billed nursing services.

Pharmacy Providers
All pharmaceuticals associated with the delivery of an infusion therapy are billed through the Pharmacy Program using the individual product National Drug Code (NDC). Pharmacy providers that are also Montana Healthcare Programs-enrolled home infusion therapy services providers should refer to the Prescription Drug Program manual for billing instructions.

End of Billing Procedures Chapter

How Payment Is Calculated

Overview

Although providers do not need the information in this chapter in order to submit claims to Montana Healthcare Programs, the information allows providers to understand how payment is calculated and to predict approximate payment for particular claims. Examples are for the July 1, 2013 fee schedule and may not apply at other times.

Many Montana Healthcare Programs payment methods are based on Medicare, but there are differences. In these cases, the Montana Healthcare Programs method prevails.

How Payment Is Calculated on TPL Claims

When a member has coverage from both Montana Healthcare Programs and another insurance company, the other insurance company is often referred to as third party liability (TPL). In these cases, the other insurance is the primary payer (as described in the Coordination of Benefits chapter of this manual), and Montana Healthcare Programs makes a payment as the secondary payer. For example, a member receives 30 units of antiemetic therapy (S9351) and 30 days of pain management therapy (S9327) during a 30-day period. The third party insurance is billed first and pays $5,000.00. The Montana Healthcare Programs allowed amount for these services totals $6,900.00. The amount the insurance paid ($5,000.00) is subtracted from the Montana Healthcare Programs allowed amount ($6,900.00), leaving a balance of $1,900.00, which Montana Healthcare Programs will pay if all prior authorization criteria is satisfied.

How Payment Is Calculated on Medicare Crossover Claims

When a member has coverage from both Montana Healthcare Programs and Medicare, Medicare is the primary payer as described in the Coordination of Benefits chapter of this manual. Montana Healthcare Programs then makes a payment as the secondary payer. For home infusion services covered in this manual, Montana Healthcare Programs’s payment is calculated so that the total payment is either the Montana Healthcare Programs allowed amount less the Medicare paid amount or the sum of the Medicare coinsurance and deductible, whichever is lower. This method is sometimes called lower of pricing.

Other Factors That May Affect Payment

When Montana Healthcare Programs payment differs from the fee schedule, consider the following:

The Department pays the lower of the established Montana Healthcare Programs fee or the provider’s charge
Modifiers SH and SJ reduce payment on multiple concurrent therapies.
The member may have an incurment amount that must be met before Montana Healthcare Programs will pay for services. (See the Coverage for the Medically Needy section in the Member Eligibility and Responsibilities chapter of the General Information for Providers manual.)
Date of service; fees for services may change over time.
Medicare, and/or TPL payments, which are shown on the remittance advice.

End of How Payment is Calculated Chapter

Appendix A - Forms

These forms are available on the Forms page of the Provider Information website.

Request for Medicaid Home Infusion Therapy Authorization
Individual Adjustment Request
Paperwork Attachment Cover Sheet

End of Appendix A Chapter

Definitions and Acronyms

This section contains definitions and acronyms specific to this provider type. For additional definitions and acronyms, choose the Definitions and Acronyms link in the left menu on the Provider Information website.

Bolus

A small volume of drug, which is administered directly into the vein, usually over a time period of 3–5 minutes.

Continuous

A controlled method of prolonged drug administration that includes the ability to control the delivery rate. This system permits the drug to be available to the body at a constant level.

Infusion

A parenteral solution administered intravenously or subcutaneously over an extended period of time. Typically requires an infusion pump, but may be accomplished by gravity feed.

Infusion Device/Infusion Pump

Electronic or mechanical device designed to provide continuous, intermittent, circadian, cyclical and/or bolus delivery of medications or nutrients via parenteral. Infusion pumps are generally considered to be closed systems, which helps to prevent inadvertent contact with sterile solutions. Infusion devices may be disposable or reusable. All are covered within the per diem.

Intravenous (IV)

Injection of a solution directly into the vein, usually the cephalic or median basilica vein of the arm.

National Drug Code (NDC)

An 11-digit number the manufacturer assigns to a pharmaceutical product and attaches to the product container at the time of packaging that identifies the product’s manufacturer, dose form and strength, and package size.

Parenteral

Denoting any medication route other than the alimentary canal, such as intravenous, subcutaneous, intramuscular, or mucosal.

Subcutaneous

Infusion of solutions into the subcutaneous tissue beneath the skin.

End of Definitions and Acronyms Chapter

Index

Previous editions of this manual contained an index.

This edition has three search options.

1.Search the whole manual. Open the Complete Manual pane. From your keyboard press the Ctrl and F keys at the same time. A search box will appear. Type in a descriptive or key word (for example "Denials". The search box will show all locations where denials discussed in the manual.

2.Search by Chapter. Open any Chapter tab (for example the "Billing Procedures" tab). From your keyboard press the Ctrl and F keys at the same time. A search box will appear. Type in a descriptive or key word (for example "Denials". The search box will show where denials discussed in just that chapter.

3.Site Search. Search the manual as well as other documents related to a particular search term on the Montana Healthcare Programs Site Specific Search page.

End of Index Chapter

End of Home Infusion Therapy Services Manual

Update Log

Publication History

This publication supersedes all previous Home Infusion Therapy Service
handbooks. Published by the Montana Department of Public Health & Human
Services, June 2004.

Updated May 2008, April 2012, September 2014, January 2016, December 2016, September 2017, January 2020, and July 2021.

Update Log

07/01/2021

The Other Departments section of the Introduction Chapter was revised by removing references to BCBS.

01/01/2020

Cost Share references removed and Cost Share section changed to "Co-Payments section.
Term "Medicaid" replaced with "Montana Healthcare Programs" throughout the manual.
Term "Patient" changed to "Member".

09/26/2017
Home Infusion Therapy Services Manual converted to an HTML format and adapted to 508 Accessibility Standards.

01/06/2017
In summary, The cost share section of the Billing Procedures Chapter was revised and the entire manual was revised to incorporate the initial 508/ADA adaptations agreed upon at the September 2016 Manuals committee meeting including the removal change bars, non-essential pictures, and empty pages. The date on the cover page was also revised.

12/31/2015
Home Infusion Therapy, January 2016, HELP Plan Related Updates and Others

03/02/2015
Home Infusion Therapy, September 2014: Entire Manual

04/13/2012
Home Infusion Therapy, April 2012: Covered Services

End of Update Log Chapter

Table of Contents

Key Contacts and Key Websites

Hours for Key Contacts are 8:00 a.m. to 5:00 p.m. Monday through Friday (Mountain Time), unless otherwise stated. The phone numbers designated only “In-state” will not work outside Montana. For additional contacts and websites, see the Contact Us link in the left menu on the Provider Information website.

Key Contacts:

Licensure Bureau

(406) 444-2676 Phone
(406) 444-1742 Fax

Quality Assurance Division
DPHHS
2401 Colonial Drive, 2nd Floor
P.O. Box 202953
Helena, MT 59620-2953

Prior Authorization Unit
For prior authorization requests or for authorization for therapy requests not included in the Medicaid fee schedule:

800-395-7961
406-443-6002 Helena

Mail backup documentation to:

Mountain-Pacific Quality Health
3404 Cooney Drive
Helena, MT 59602

Fax backup documentation to:

800-294-1350
406-513-1928 Helena

Key Websites:

Health Resources Division - https://dphhs.mt.gov/hrd

The Health Resources Division (HRD) administers Medicaid Physician, Acute and Hospital/Clinic healthcare services for low-income and disabled Montanans and oversees the benefits of the Healthy Montana Kids plan. HRD provides administration, policy development, and reimbursement for primary and acute portions of the Medicaid program.

Medicaid Mental Health and Mental Health Services Plan (MHSP) - https://dphhs.mt.gov/bhdd/mentalhealthservices/index

Mental health services information for Medicaid and MHSP.

End of Key Contacts and Key Websites Chapter

Introduction

Thank you for your willingness to serve members of the Montana Healthcare Programs and other medical assistance programs administered by the Department of Public Health and Human Services.

Rule References

Providers must be familiar with all current rules and regulations governing the Montana Healthcare Programs. Provider manuals are to assist providers in billing Montana Healthcare Programs; they do not contain all Montana Healthcare Programs rules and regulations. Rule citations in the text are a reference tool; they are not a summary of the entire rule. In the event that a manual conflicts with a rule, the rule prevails. Links to rules are available on the Provider Information website. Paper copies of rules are available through the Secretary of State’s office. See the Contact Us link in the left menu on the Provider Information website.

Providers are responsible for knowing and following current Montana Healthcare Programs rules and regulations.

In addition to the general Montana Healthcare Programs rules outlined in the General Information for Providers manual, the following rules and regulations are also applicable to the home infusion therapy program:

Code of Federal Regulations (CFR)
- 42 CFR 440.70
Social Security Act (USC)
- 42 USC 1396r – 8(G)
Montana Codes Annotated (MCA)
- MCA 50-5-101 – 50-5-213, 17-6-103
Administrative Rules of Montana (ARM)
- ARM 37.86.1501 – 37.86.1506 Home Infusion Therapy
- ARM 37.106.2401 – 2433 Home Infusion Therapy Agency

Claims Review (MCA 53-6-111, ARM 37.85.406)

The Department is committed to paying Montana Healthcare Programs providers’ claims as quickly as possible. Montana Healthcare Programs claims are electronically processed and usually are not reviewed by medical experts prior to payment to determine if the services provided were appropriately billed. Although the computerized system can detect and deny some erroneous claims, there are many erroneous claims that it cannot detect. For this reason, payment of a claim does not mean that the service was correctly billed or the payment made to the provider was correct. The Department performs periodic retrospective reviews, which may lead to the discovery of incorrect billing or incorrect payment. If a claim is paid and the Department later discovers that the service was incorrectly billed or paid or the claim was erroneous in some other way, the Department is required by federal regulation to recover any overpayment, regardless of whether the incorrect payment was the result of Department or provider error or other cause.

Manual Organization

This manual provides information specifically for providers of home infusion therapy services. Additional essential information for providers is in the separate General Information for Providers manual. Providers are responsible for reviewing both manuals.

A table of contents and an index allow you to quickly find answers to most questions. For a list of key contacts and key websites, see the previous chapter and the Contact Us link in the left menu on the Provider Information website. The margins contain important notes with extra space for writing notes. There is also space on the inside of the front cover to record your National Provider Identifier (NPI) for quick reference when calling Provider Relations.

Manual Maintenance

In order to remain accurate, manuals must be kept current. Changes to manuals are provided through provider notices and replacement pages, which are posted on the Provider Information website. When replacing a page in a paper manual, file the old pages and provider notices in the back of the manual for use with claims that originated under the old policy.

Getting Questions Answered

The provider manuals are designed to answer most questions; however, questions may arise that require a call to a specific group (such as a prior authorization contractor or Provider Relations). For a list of key contacts and key websites, see the previous chapter and the Contact Us link in the left menu on the Provider Information website. Montana Healthcare Programs manuals, provider notices, replacement pages, fee schedules, forms, and more are available on the Provider Information website.

Other Department Programs

The Montana Healthcare Programs home infusion services in this manual are not benefits of the Mental Health Services Plan (MHSP), so the information in this manual does not apply to the MSHP program. For more information on the MHSP program, see the mental health manual available on the Provider Information website.

End of Introduction Chapter

Covered Services

General Coverage Principles

This chapter provides covered services information that applies specifically to services provided by home infusion therapy providers. Like all healthcare services received by Montana Healthcare Programs members, services rendered by these providers must also meet the general requirements listed in the General Information for Providers manual, Provider Requirements chapter.

Home infusion therapy is a comprehensive treatment program of pharmaceutical products and clinical support services provided to members who are living in their home, a nursing facility, or any setting other than a hospital. A physician’s authorization (prescription) for home infusion therapy allows Montana Healthcare Programs members to avoid or leave the hospital care setting and receive medical care at home. Under the guidance of the member’s physician, the licensed home infusion therapy provider develops and implements a treatment program to meet the particular requirements of the member.

Services within Scope of Practice (ARM 37.85.401)
Services are covered only when they are within the scope of the provider’s license.

Licensing (ARM 37.86.1502 and ARM 37.85.402)
Home infusion therapy providers must be licensed under Montana’s healthcare service licensing laws. To obtain licensing requirements and procedures, contact the DPHHS Health Care Facility Licensure Bureau. (See Key Contacts.) A provider must be enrolled with Montana Healthcare Programs as a home infusion therapy provider. Providers who are also providing pharmacy services must enroll with Montana Healthcare Programs as a pharmacy provider.

Services for Children (ARM 37.86.2201–2235)
The Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services program is a comprehensive approach to healthcare for Montana Healthcare Programs members ages 20 and under. It is designed to prevent, identify, and then treat health problems before they become disabling. Under EPSDT, Montana Healthcare Programs eligible children may receive any medically necessary covered service, including all home infusion therapy services described in this manual. All applicable Passport to Health and prior authorization requirements apply.

Non-Covered Services (ARM 37.85.207)

The Department determines which therapies are allowed as home infusion therapy services in consultation with the Department's Drug Use Review Board.

Montana Healthcare Programs does not cover the following services:

Medications which can be appropriately administered orally, through intramuscular or subcutaneous injection, or through inhalation;
Drug products that are not FDA-approved or whose use in the non-hospital setting present an unreasonable health risk to the member; or
Services provided to Montana Healthcare Programs members who are absent from the state, with the following exceptions:
- Medical emergency.
- Required medical services are not available in Montana. Prior authorization may be required. See the Passport to Health manual.
- If the Department has determined that the general practice for members in a particular area of Montana is to use providers in another state.
- When out-of-state medical services and all related expenses are less costly than in-state services.
- When Montana makes adoption assistance or foster care maintenance payments for a member who is a child residing in another state.

Verifying Coverage
The easiest way to verify coverage for a specific service is to check the Department’s fee schedule for your provider type. In addition to being listed on the fee schedule, all services provided must also meet the coverage criteria listed in this chapter and in the Provider Requirements chapter of the General Information for Providers manual. Use the fee schedule in conjunction with the detailed coding descriptions listed in the CPT and HCPCS diagnosis coding books. Use the fee schedule and coding books that pertain to the date of service.

Fee schedules are available on the Provider Information website.

Items Included in the Montana Healthcare Programs Rate

The following products and services are included in Montana Healthcare Programs’s per diem rate for home infusion therapy services. These items may not be billed separately to Montana Healthcare Programs. Each per diem represents a 24-hour period.

All business, overhead, and operational expenses.
Home infusion therapy agency staff service.
- Case management activities including coordination of treatment with other healthcare providers.
- Coordination of benefits, care, and services.
- Development of member assessment and member education materials.
- Development and monitoring of nursing care plans.
- Coordination of education, training, and competency of field nursing staff (or sub-contracted agencies).
- Comprehensive 24/7 delivery and pick-up services. Includes 24/7 availability of a dedicated infusion team consisting of pharmacists, nurses, and all other medical professionals responsible for clinical response, problem solving, troubleshooting, question answering, and other professional duties.
- Any other services provided by the agency staff related to the member’s home infusion.
- Infusion therapy equipment and supplies including, but not limited to, the following:
  - Infusion therapy administration devices (e.g., durable, reusable infusion pumps and elastomeric, disposable infusion pumps).
  - Needles, gauze, sterile tubing, catheters, dressing kits, and other supplies necessary for the safe and effective administration of infusion therapy.
  - Infusion access devices both short peripheral vascular devices and subcutaneous access devices, excluding peripherally inserted central catheter (PICC) lines, midlines, and other centrally placed lines.
  - Other applicable supply expenses.
  - Pharmacist professional services.
  - Development and implementation of pharmaceutical care plans.
  - Coordination of care with physicians, nurses, members, member’s family, other providers, and other caregivers.
  - Member/caregiver education.
  - Sterile procedures, including preparation and compounding of infusion medications, clean room upkeep, vertical and horizontal laminar flow hood certification and all other biomedical procedures necessary for a safe environment.
  - Initial and ongoing member assessment and clinical monitoring to include but not limited to:
    - Medication and dosage changes based upon clinical findings.
    - Pharmacokinetic dosing.
    - Monitoring of potential drug interactions.
    - Medication profile setup.
    - Recommend appropriate laboratory monitoring.
    - Review and interpretation of laboratory values and therapy progression and reporting clinical information to the member’s physician and other healthcare providers.
  - 24/7 call status.