Home Drug Infusion Therapy Under

Medicare

May 1992

OTA-H-509

NTIS order #PB92-182112
Recommended Citation:

U.S. Congress, Office of Technology Assessment, Home Drug Infusion Therapy Under

Medicare, OTA-H-509 (Washington, DC: U.S. Government Printing Office, May 1992).
Foreword

Home drug infusion therapy (HDIT) is an example of a mode of treatment that involves

a multitude of new technologies: innovations in medical equipment and supplies, new drugs

and drug protocols, and novel ways of organizing and delivering health care services. The

rapid development and diffusion of HDIT is a product of our time; it has bloomed in an era

in which the United States has searched with increasing intensity for ways to provide both

better and cheaper health care to its citizens.

HDIT holds out the promise of making sophisticated, medically intensive drug therapies

available to Medicare patients in their own homes, but the full consequences of a Medicare

HDIT benefit are unclear. Because of interest in such a benefit and concern about its potential

costs, the Senate Committee on Finance asked OTA to examine Medicare coverage and

payment issues relating to this technology. This report was prepared in response to that

request.

A related OTA report, Outpatient Immunosuppressive Drugs Under Medicare, was

released in August 1991.

~ Director

. . . w
OTA Project Staff—Home Drug Infusion Therapy Under Medicare

Roger C. Herdman, Assistant Director, OTA

Health and L&e Sciences Division

Clyde J. Behney, Health Program Manager

Project Staff

Elaine J. Power, Project Director

Sharon Y. Hamilton, Research Assistant

David P. Reeker, Congressional Fellowl

Leah Wolfe, Analyst

Other Contributing Staff

Frank Gianfrancesco, Senior Analyst2

Arna Lane, Research Assistant

Administrative Staff

Marian Grochowski, Office Administrator

Kim Holmlund, Word Processor Specialist4

Eileen Murphy, P.C. Specialist

Contractors

Tom Grarnnemann, Brookline, MA

Julie Ostrowsky, Chicago, IL

1Until May 1991

2Until August 1990

3Until January 1992

4Since December 1991

iv
Home Drug Infusion Therapy Under Medicare: Discussion of the OTA Draft

List of Workshop Participants

Maredith F. Buco

Consultant

Blue Cross and Blue Shield Association

Chicago, IL

Patrick A. Carmichael

Director of Pharmaceutical Service

Visiting Nurse Service, Inc.

Atlanta, GA

(Representing Visiting Nurse Association

of America)

William A. Dombi

Director, Center for Health Care Law

National Association for Home Care

Washington, DC

Thomas Grannemann

Senior Economist

Systemetrics

Lexington, MA

Craig Jeffiies

Executive Director

Health Industry Distributors Association

Alexandria, VA

Chris M. Kozma

Assistant Professor

University of South Carolina

College of Pharmacy

Columbia, SC

Mary Larkin

Executive Director, CEO

Intravenous Nurses Society

Belmont, MA

Dan Lerrnan

Independent Home Care Consultant

Chicago, IL

Khalid Mahrnud

Director

American Academy of Home Care Physicians

Edina, MN

Alan Parver

President

National Alliance for Infusion Therapy

Washington, DC

Tim Redmon

Director, Home Health Care Regulatory Affairs

National Association of Retail Druggists

Alexandria, VA

Joanne G. Schwartzberg

Director, Department of Geriatric Health

American Medical Association

Chicago, IL

Brian G. Swift

Manager, Jefferson Home Infusion Service

Philadelphia, PA

(Representing American Society of Hospital

Pharmacists)

Alan D. Tice

President, OPIVITA (Outpatient Intravenous

Infusion Therapy Association)

Tacoma, WA

Elisa Tunanidas

Health Care Financing Administration

Baltimore, MD

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop participants.

The workshop participants do not, however, necessarily either endorse or disagree with the findings and conclusions of this

report. OTA assumes full responsibility for the report and the accuracy of its contents.

v
List of Abbreviations

—American Hospital Association

AIDS —acquired immunodeficiency

syndrome

ALOS —average length of stay

—American Medical Association

ASHP —American Society of Hospital

Pharmacists

AWP —average wholesale price

BC/BS —Blue Cross and Blue Shield

Association

BCBS/NCA-Blue Cross and Blue Shield of the

National Capital Area

CFF -Cystic Fibrosis Foundation

CFR -Code of Federal Regulations

CHAMPUS -Civilian Health and Medical

CHF

COP

DHHS

DME

DRG

ESRD

FDA

FI

FR

FTE

GAO

G-CSF

GM-CSF

HCFA

HDIT

Program of the Uniformed Services

-congestive heart failure

-conditions of participation

—U.S. Department of Health and Human

Services

-durable medical equipment

-diagnosis-related group

-end-stage renal disease

—Food and Drug Administration (U.S.

Public Health Service)

—fiscal intermediary

—Federal Register

—full-time equivalent

-General Accounting Office

—granulocyte colony stimulating

factor

—granulocyte microphage-colony

stimulating factor

—Health Care Financing

Administration (DHHS)

—home drug infusion therapy

HHA —home health agency

HMO —health maintenance organization

INS —Intravenous Nurses Society

Iv —intravenous

JCAHO —Joint Commission on the

Accreditation of Healthcare

Organizations

MCCA —Medicare Catastrophic Coverage Act

MCP —monthly cavitation payment

NABP —National Association of Boards of

Pharmacy

NAHC —National Association for Home Care

NAIT —National Alliance for Infusion

Therapy

NLN/CHAP-National League for Nursing’s

Community Health Accreditation

Program

OBRA -Omnibus Budget Reconciliation Act

OIG -Office of Inspector General (DHHS)

OTA -Office of Technology Assessment

(U.S. Congress)

PCA —patient-controlled analgesia

Pharm.D. -doctor of pharmacy

PICC —peripherally inserted central catheter

PPIC —Preferred Physician’s Infusion

Center, Inc.

PRO —peer review organizations

RN —registered nurse

R. Ph. —registered pharmacist

SNF —skilled nursing facility

SSA -Social Security Act

TPN —total parenteral nutrition

VNA —Visiting Nurses Association

VNA-LA —Visiting Nurses Association of Los

Angeles

vi
Contents

Chapter 1.

Chapter 2.

Chapter 3.

Chapter 4.

Chapter 5.

Chapter 6.

Chapter 7.

Page

Summary and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

The Safety and Effectiveness of Home Drug Infusion Therapy . . . . . . . . . . . . . . . . . 27

Home Drug Infusion Therapy Equipment and Semites . . . . . . . . . . . . . . . . . . . . . . . . 45

The Home Drug Infusion Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Quality Assurance in Home Drug Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Covering Home Drug Infusion Therapy: Implications for Medicare . . . . . . . . . . . . . 111

Paying for Home Drug Infusion Therapy Under Medicare.. . . . . . . . . . . . . . . . . . . . 133

Appendix A. Method of the Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Appendix B. Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Appendix C.Home Intravenous Drug Therapy: Proposed Regulations Under the

Medicare Catastrophic Coverage Act.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Appendix D.A Basic Economic Model of Home Drug Infusion Provider Behavior . . . . . . . . 192

Appendix E. Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..** 201

vii
Chapter 1

SUMMARY AND OPTIONS
Contents

Page

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

What Is Home Drug Infusion Therapy? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

The Home Drug Infusion Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Is HDIT Safe and Effective? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Issues and Options for Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Implications of Medicare Coverage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Coverage Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Administrative Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Payment Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Research and Demonstration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Figure

Figure Page

1-1. Three Examples of Potential Relationships Between Providers and Patients

Receiving Both Home Drug Infusion Therapy and Routine Home Health

Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Tables

Table Page

l-1. Existing Medicare Benefits Applicable to Home Drug Infusion Therapy . . . . . . . . . . 7

1-2. Issues and Options for Covering Home Drug Infusion Therapy Under

Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

1-3. Options for Conducting Research and Demonstrations Relating to Home Drug

Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Chapter 1

SUMMARY AND OPTIONS

Introduction

Few changes in the organization and provision of

health care in the United States have been as

dramatic as the shift away from hospital inpatient

care that occurred during the 1980s. The past decade

witnessed tremendous growth in such diverse activities as the establishment of ambulatory surgery

centers, physicians’ office laboratory testing, and

freestanding cancer and cardiac centers (272a). An

especially striking change was the development and

maturation of a system to provide intensive and

highly sophisticated medical treatments to patients

in their own homes. Home drug infusion is one such

medical therapy.

Almost unknown before the late 1970s, home

drug infusion therapy (HDIT) is now a major

industry with net revenues in the billions of dollars

(289,307). Its growth is no accident. Many health

insurers view this technology as a potential costsaver. Providers view it as a welcome way of

enhancing revenues. Market analysts view it as an

investment opportunity. And patients view HDIT as

an opportunity to resume a reasonably normal life

while continuing sophisticated medical treatment.

But the widespread enthusiasm for this novel

mode of medical therapy has been tempered in some

cases by uncertainty about its potential applications

and possible hidden costs. Medicare, the Nation’s

single largest health care insurer, has no benefit that

explicitly covers HDIT. The Medicare Catastrophic

Coverage Act of 1988 (MCCA, Public Law 100-

360), which would have extended coverage to this

benefit, was repealed before it was ever implemented. In 1990, in the context of continued interest

in such a benefit, the Senate Committee on Finance

asked the Office of Technology Assessment (OTA)

to revisit the implications of covering HDIT under

Medicare and to analyze alternative ways of paying

for this therapy. This report was prepared in response

to that request.l

Although the literature on HDIT is considerable,

most of it deals either with specific techniques and

procedures or with the feasibility of providing this

service. To gather information for this study, therefore, OTA relied not only on the published literature

but also on site visits to HDIT providers, discussions

with persons involved in HDIT, and data supplied by

individual insurers and providers (see app. A). The

remainder of this chapter presents a summary of

OTA’s findings and conclusions and contains options for congressional consideration.

Summary and Conclusions

What Is Home Drug Infusion Therapy?

OTA found that HDIT is a medical therapy that

involves the prolonged (and usually repeated) injection of pharmaceutical products, most often delivered intravenously (into a vein) but also sometimes

delivered via other routes (e.g., subcutaneously or

epidurally).2 Some drugs, such as antibiotics, maybe

infused over relatively short periods (e.g., 30 minutes) a few times each day; others, such as analgesics

to relieve extreme pain, maybe administered around

the clock. All of these infusion therapies have in

common the need for specialized equipment and

supplies and skilled nursing care in order to be

administered safely. At present, patients or their

family caregivers3 are usually, although not always,

trained to perform some of these needed skilled

services themselves.

Until the end of the 1970s, drug infusion therapy

was almost always a hospital inpatient procedure.

The components of care associated with this therapy

(e.g., inserting the needle in the vein, regulating the

infusion, monitoring the patient, and changing the

dressing (bandage) around the needle’s entry site)

usually required the meticulous care of trained

nurses to avoid life-threatening infections and allergic reactions. Indeed, these requirements still exist.

During the late 1970s, however, a few hospitals and

1 Aotherreportprepared in response to the same general request OutpatientZmmunosuppressive Drugs Under Medicare, was released in September

1991.

z ~~subutiwusly>! r~ers t. ~jwtiom ~der me s-“epid~~y” refers to injections into the epidund sp~e mo~d tie sP~ ~rd”

3 In this repo~ “family caregivers” refer to both immediate family members and other unpaid individurds (e.g., close fiends) who are trained to

perform some of the nursing-related infusion services.

-3-
4. Home Drug Infusion Therapy Under Medicare

physicians began to train highly selected patients

with prolonged infections (or their caregivers) to

perform some of these procedures themselves at

home (16,188,290,324). In the early 1980s, with the

publication of successful results from some of these

programs and the implementation of payer-induced

constraints on hospital inpatient care, a new mode of

therapy-and a new industry-was born.

This report deals with the drug and biological

infusion treatments (including blood transfusions)

being used in the home but not yet explicitly covered

by Medicare in that setting. Medicare does cover

total parenteral nutrition (TPN) in the home for

individuals with long-term disabilities that prevent

them from being able to digest food.4 TPN has many

similarities to the therapies discussed in detail in this

report, and many providers of HDIT also provide

TPN and other nutritional products and services. In

fact, nutritional therapies still produce a substantial

proportion of the revenues for the home infusion

industry (34,307). However, because the purpose of

this report is to examine other noncovered infusion

therapies, TPN is discussed only as it is relevant to

the issues surrounding HDIT.

Uses and Recipients of Therapy

The number of patients who currently receive

drug infusion therapy at home is unknown but

probably in the vicinity of a quarter of a million

persons per year. A 1987 market analysis estimated

that in the previous year, approximately 39,000 such

patients received home treatment, and it predicted

that over 225,000 would do so in 1990 (289). A more

recent investment report estimated the 1990 market

at roughly 200,000 patients (275). Given that the

market has continued to grow, a 1991 estimate of

between 200,000 and 250,000 persons in HDIT

during the year seems reasonable.5

Most HDIT patients presently served are nonelderly adults. Two HDIT providers with data on

patient age report that the great majority of their

patients are between the ages of 18 and 65 (3,250).

About 15 percent of each provider’s patients are

elderly (age 65 or over), a figure that includes some

patients on nutritional and other infusion therapies

as well as HDIT A survey of six national infusion

specialty firms found that slightly less than 18

percent of patients are age 65 or over (256); again,

this number included patients receiving TPN. Conversations with other providers suggest that many of

them consider elderly patients on HDIT to be

relatively rare. Thus, excluding patients on TPN, a

“best guess” estimate is that about 10 to 15 percent

of current HDIT patients are elderly. Based on these

very rough assumptions, OTA estimates that

between 20,000 and 35,000 elderly individuals

received HDIT in 1991.

HDIT patients fall into a few major groups and

many smaller ones. The first and largest group is

composed of those patients who require intravenous

(IV) drug therapy for infections (e.g., bone infections) that require prolonged treatment and are not

usually susceptible to oral drugs. Persons with

cancer make up another major group; these individuals may need not only antineoplastic drugs to combat

the cancer but also antibiotics, analgesics, hydration,

and other infusion therapies at times. A third

category of HDIT recipients are those with AIDS.

Like persons with cancer, those with AIDS may be

treated with any of a number of therapies (e.g.,

antibiotics, antifungal medications, and blood transfusions) depending on their particular medical

conditions.

Other categories of individuals whose conditions

are sometimes treated with home infusion therapies

include individuals with congestive heart failure,

persons with certain immune disorders, pregnant

women receiving infusions of drugs to prevent

premature labor, and patients with severe anemia or

other blood disorders who need blood transfusions.

Some of these treatments are experimental or are not

yet widely available in the home.

Components of Therapy

Drugs-At present, antibiotics and other antiinfectives are the most common drugs involved in

home infusion therapy. Based on estimates by

market analysts and other sources, it appears that

about two-thirds of current drug orders for HDIT

involve anti-infective drugs (34,193,193a).G Ap4 ~~pm~t=~~~ ~~fem genm~y t. meth~s of ams~ation that bypass the digestive tract. ‘rpN is nutient solution that is ~“ “ tered

intravenously.

5 This number probably includes some individuals receiving outpatient clinic-based rather than home therapy, since the market analyses did not

distinguish clearly between these two settings.

6 Although antibiotics are responsible for about two-thirds of HUT drug orders, only about half of HDIT patients receive antibiotics (193%256).
Chapter 1-—Summary and Options .5

proximately another 15 percent of HDIT drugs are

antineoplastics or pain medications. The diverse

remaining group of drugs makes up somewhere

between 10 and 20 percent of HDIT at present.

Equipment—Whatever the route of administration, HDIT requires two crucial pieces of equipment:

the access device that is inserted into the body (e.g.,

an N catheter), and the Infusion device that controls

the rate of drug flow. The choice of this equipment

depends on the patient’s condition, the length and

type of drug therapy prescribed, and the preferences

of the patient and provider. The methods of access

and infusion control chosen, in turn, can affect the

need for supplies and for nursing care and the overall

cost of the therapy.

The continual emergence of new home infusion

therapy technologies broadens the types of patients

who can be treated at home and changes the

parameters of service delivery. Some recently developed technologies have reduced the amount of

skilled nursing intervention required for patients at

home and made it easier for patients to selfadminister complex drug regimens (see ch. 3).

Nonetheless, despite the development of increasingly sophisticated infusion pumps over the past

decade, less expensive gravity drip systems are still

safe and appropriate for some patients receiving

antibiotic and hydration therapies.

Services-HDIT involves a complex array of

services that must be coordinated with each other.

They also must be coordinated as a unit with any

other home health care services and supplies the

patient receives. Although the responsibilities and

involvement of particular types of personnel vary

greatly among HDIT providers, all HDIT requires

that at least certain core services be provided in some

way.

. Pharmacy services involve, at a minimum,

compounding the drugs to be infused and being

available to respond to emergencies and questions regarding the therapy.7 Pharmacists’ responsibilities often also extend to participating

in patient education, anticipating drug side

effects, dealing with nonemergency issues relating to the therapy, monitoring patients via

conversations with nurses or patients themPhoto credit: Ivion Corp.

New technologies such as this multiple-drug infusion pump

●

●

allow patients to self-administer complex drug

regimens at home.

selves, monitoring laboratory results, and collaborating with physicians on prescription changes.

Nursing services include educating the patient

and family caregiver regarding administration

of the infusion and care of the infusion site,8

dressing and infusion site changes, and inhome monitoring of the patient’s health status.

Nurses may perform a wide variety of other

functions as well, ranging from overseeing the

actual infusion to patient assessment and care

coordination.

Physician services provided by the patient’s

physician include ordering the home care,

prescribing the therapy, overseeing the patient’s progress through patient visits and

monitoring laboratory and clinical reports,

dealing with emergencies, and making changes

in the therapy as needed. In practice, the extent

of physician involvement in HDIT appears to

be highly varied. Some physicians take a very

active role—for example, seeing all patients in

person at least twice a week and holding

extensive telephone conversations with nurses

and pharmacists involved in the therapy—

7 Larger infusion providers often employ pharmacy technicians to assist pharmacists in compounding drugs.

8 Pharmacists, social workers, or other professionals may also be involved in aspects of patient assessment and education.
6. Home Drug Infusion Therapy Under Medicare

●

while others have much less contact with the

patient and professional caregivers during the

course of the therapy.

Laboratory services are necessary to monitor

the patient’s status and response to therapy as

detected through blood samples and other tests.

Most HDIT providers do not have in-house

laboratories.

Based on numerous site visits and conversations

with HDIT providers, patients, and others, it appears

that most HDIT providers are skilled at coordinating

the services specific to the home infusion therapy.

For patients receiving other home care as well,

however (e.g., basic home nursing, physical therapy,

or respiratory therapy), the complex of HDITspecific services must also be coordinated with these

home health care services. Such coordination across

different home care services may be particularly

important for Medicare patients, but it is a service

many HDIT providers are not currently wellequipped to offer.

Many of the tasks necessary for HDIT would be

performed by a skilled nurse in a hospital setting. At

home, however, these tasks can often be performed

by the patient or a family caregiver who has been

taught the proper techniques by a qualified health

professional. Medicare beneficiaries are more

likely than other patients to have disabilities that

limit their ability to learn or perform infusion

techniques and other most basic self-care tasks

(e.g., dressing and bathing). Their spouses may

also have functional limitations. Thus, OTA

concludes, Medicare patients are more likely

than other patients to require paid assistive

services in order to receive medical care such as

drug infusion therapy at home. If the frequency

and intensity of professional services required by a

home infusion patient are great (e.g., a functionally

disabled patient on a 4-dose/day antibiotic regimen

who has no family caregiver available), a skilled

nursing facility (SNF) or other nonhospital institutional setting that offers 24-hour care might be a

more reasonable alternative to hospitalization than

traditional home care.

Current Medicare Coverage of HDIT

Medicare pays for “medically necessary” services and supplies associated with drug infusion when

it takes place in hospitals, outpatient clinics, or

physicians’ offices. (Some of these settings (e.g.,

physicians’ offices) may be subject to locally set

limitations on infusion payments and coverage.)9

Medicare does not have an HDIT benefit; the need

for this therapy when provided at home does not

qualify a beneficiary for Medicare coverage of any

particular items. However, certain components of

HDIT are sometimes covered by Medicare under

existing benefits for beneficiaries in their own

homes.

The core nursing services used in HDIT are

sometimes covered by Medicare under the Part A

home health benefit, while pharmacy services and

supplies are sometimes covered under the Part B

durable medical equipment (DME) benefit (table

1-1).10 The home health benefit covers intermittent

skilled nursing care, and home infusion therapy

patients’ need for such care would also qualify them

for additional home health aide and therapy services.

The Part B DME benefit covers reusable equipment

such as infusion pumps and the supplies associated

with such equipment. Some carriers also cover a

wide variety of drugs when used in an infusion pump

(365) (see ch. 6).

Current coverage of the core HDIT services has a

number of problems. First, it is incomplete and

fragmented; coverage is piecemeal, administratively

split between Part A and Part B fiscal intermediaries

(FIs-Medicare’s administrative contractors), and

highly variable. Some carriers, for example (the Part

B FIs), interpret the DME benefit to include even

coverage for antibiotics administered by gravity drip

(365). Other carriers almost never pay for any drug

through this benefit. Second, there are no guidelines

for who can provide HDIT, and thus there are no

minimum quality standards for such providers under

Medicare.

A third problem with the existing benefit structure

is that it tends to discourage the most independently

functional patients from leaving the hospital. To be

9 ~Sion iS ~w Sometimes provid~ ~ hospic~ @ ~~ed nurs@ fmilities (Sws). Although M~ic~e “covers” the infusion ill th(Xe iIIShIiC~,

payment rates to hospices and SNPS are generally unaffected by whether the service is performed. These providers thus have a strong disincentive to

offer inlision while a patient is served by the hospice or SNF.

10 my the pm B D~ &nefit Someties encompmses ~gs. me pm A D~ benefit tit is Subsumd under the home health care benefit

speeiilcally excludes drugs from coverage.
Chapter l-Summary and Options .7

Table l-l—Existing Medicare Benefits Applicable to Home Drug Infusion Therapy

Components of Selected relevant

Benefit HDIT covered limitations

Part A

Home health services

Hospice

Part B

Durable medical equipment

Laboratory services

Physician services

Hospital outpatient services

Nursing, supplies,durable medical

equipment (DME).

Those components the hospice

chooses to provide to its in-home

patients.

Pumps, other DME, supplies, selected drugs.

Laboratory tests.

Physician visits, some officebased infusion therapy services

provided to home patients.a

On-site outpatient infusion therapy

services provided to home patients. a

Patient must be homebound. Drugs

not covered under home health

DME benefit.

Providing infusion does not affect

hospice’s flat-fee payment rate.

Drug coverage varies greatly by

carrier. Disposable “pumps” not

considered DME.

No payment for administrative responsibilities; may be local limits

on office-based therapy.

—

asome patients, forexanlple, may Url&rtake ttiek own daily routine infusion-related care but return to an OUtpi3hIt

clinic or office for more specialized services such as catheter site changes.

SOURCE: Office of Tdnology Assessment, 1992.

eligible for home health nursing benefits, for example, beneficiaries must be homebound-i.e., unable

to leave their homes without some kind of assistance. And while nearly all carriers at least sometimes pay for infused cancer therapies (analgesics

and antineoplastics) as part of the DME benefit,

considerably fewer pay for antibiotics-and some of

the latter pay only when a patient is so ill as to be

already receiving other infusion therapies.

In addition to the core pharmacy and nursing

components, Medicare routinely pays for the laboratory services associated with HDIT as part of the

standard Part B laboratory benefit (table l-l).

Medicare also routinely pays for physician services,

including physician visits (home or office) to

monitor the status of HDIT patients. However, the

program does not pay for telephone or administrative time of physicians overseeing home care plans.

Because of the level of medical monitoring needed

for HDIT patients, the amount of time spent in these

activities can be substantial. Consequently, the lack

of payment for these services-and the relative

generosity of payment for daily visits to hospitalized

infusion patients—is a disincentive for physicians to

discharge some patients to home care under the

current system.

The Home Drug Infusion Industry

The development and shape of the HDIT industry

has been influenced by two important factors. First,

the development of the industry has followed past

changes in Federal policies. Medicare coverage for

home parenteral and enteral nutrition (begun in

1977) and the implementation of prospective payment for Medicare inpatient services (in 1983) both

contributed to the explosion in the home infusion

industry that occurred during the first half of the

1980s. If Medicare should choose to cover and pay

for HDIT in the future, how it does so may have a

similarly profound impact on the shape of the

industry. Not only could the number of elderly

patients being treated at home expand far beyond the

estimated 20,000 to 35,000 now served, but Medicare’s policies could serve as a model (or a caution)

for other public and private insurance programs.

Second, the growth in the home infusion service

industry-those organizations that provide the nursing and pharmacy services and products directly to

patients—has been enabled by the technologies that

have permitted drug infusion therapy to be selfadministered in the home. Increasingly sophisticated

infusion pumps, administration kits, therapy protocols, venous access devices, and drugs that need be
8. Home Drug Infusion Therapy Under Medicare

Photo credit: CADD-PCA@ Ambulatory Infusion Pump Model 5800,

Pharmacia Deltec Inc., St. Paul, MN

Sophisticated infusion pumps have been developed for

specific segments of the HDIT market. This pump delivers

a constant dose of pain medication, with a special

button that allows the patient to self-administer

occasional larger doses as needed up to a

preprogrammed maximum amount.

administered only once or twice a day have all

contributed to the feasibility of home therapy for an

ever-growing number of patients.

As manufacturers have developed new supplies

and equipment, providers have become adept at

incorporating them and marketing both products and

services to patients, physicians, and payers. Provider

success at encouraging HDIT, in turn, stimulates

even greater effort in developing technologies for

this market.

The present assortment of HDIT providers includes a few large (national or regional) infusion

specialty providers that offer most of the basic

services and products associated with drug infusion

therapy, including pharmacy supplies and services,

equipment and medical supplies, and specialty

nursing. In addition, there are a multitude of smaller

regional and local providers, for most of whom

HDIT is a relatively small proportion of a larger

business. These local providers include home health

agencies (HHAs), community pharmacies, physicians, medical equipment suppliers, and hospitals.

In many cases, smaller providers may offer only

one or two components of the therapy directly. A

patient from a small town who is on HDIT, for

example, might receive infusion-related nursing

from the local HHA, pharmacy products and services from the local pharmacy, and an infusion pump

from the local medical equipment dealer. In fact, it

appears that many HDIT providers contract with at

least one other type of provider to provide some

components of the therapy. Where patients need

routine as well as infusion specialty nursing, the

routine nursing is ah-nest always performed by a

separate agency (except where the HHA itself is also

the primary home infusion provider) (see figure l-l).

The continually expanding revenues and, apparently, relatively high profit margins that have been

enjoyed by the HDIT industry thus far have facilitated and encouraged the entry of new providers into

the marketplace, expanding access to HDIT services

and stimulating the development of new products.

The increasing revenues are in part due to the liberal

reimbursement that these companies have often been

able to garner. Future controls over what companies

can charge Medicare patients for home infusion

therapy might slow the growth of certain sectors of

the marketplace.

Is HDIT Safe and Effective?

Home drug infusion technologies have become

commonplace. Most are effective and can be performed safely in the home when patients are

carefully selected and trained and home care providers have adequate procedures and qualified staff.

However, HDIT is not without substantial risks.

When those qualifications are not met, OTA believes that patients on home therapy can be at a high

risk of adverse events, including severe infection,

shock, and even death.

In a few cases, the effectiveness of the drug itself

used in HDIT is open to question. For example,

existing studies on long-term dobutamine, a drug

sometimes used to treat severe congestive heart

failure in the home, suggest that this use of the drug

may actually be harmful for some patients (see ch.

2). Immune globulin is an example of a product that

has some clearly indicated uses, but that is also

finding use in a variety of conditions where its

effectiveness is less well established (and its costs

high).
Chapter 1—Summary and Options .9

Figure l-l—Three Examples of Potential Relationships Between Providers and

Patients Receiving Both Home Drug Infusion Therapy (HDIT) and

Routine Home Health Services

Example 1

Laboratory

:;-< ~ .

Home health agency

(routine home health services)

Physician

Example 2

Home health agency

Pharmacy (HDITnursing, routine home DME supplier

health services)

?-y‘

Physician

Example 3

Pharmacy

(HDITpharmacy and DME)

Laboratory / 1

PATlENT

>-i

Home health agency

(HDITnursing, routine home

Physician

\ health services) I

SOURCE: Office of Technology Assessment, 1992.

Infusion therapy carries some risks regardless of

the setting in which it occurs. Although most

complications (e.g., vein irritation at the catheter

entry site) are minor if recognized and treated

immediately, conditions such as sepsis (systemic

infection) and shock (from drug allergic reactions)

can be life-threatening. Mechanical complications

of the infusion (e.g., air entering the vein) and

equipment malfunctions can also cause serious

medical problems.

Some risks (e.g., the risk of acquiring g serious

secondary infections) are probably lower when

patients are home than when they are in the hospital.

On the other hand, in the hospital, constant nursing

supervision and rapid access to sophisticated emergency care ameliorates many of the other risks of

infusion therapy. In the home, there is rarely

continuous professional monitoring, and emergency

care is not available on site. Consequently, the most

clearly appropriate drugs for the home are those in

297-913 0 - 92 - 2
10. Home Drug Infusion Therapy Under Medicare

which life-threatening side effects or complications

are rare, and those in which most side effects are

apparent when the first dose is given (which can be

monitored in a hospital or physician’s office). Many

antibiotics fit this description. Although infused

analgesics and antineoplastics require more care to

be used safely at home, the need for these therapies

lifelong by many patients may justify their use in this

setting.

OTA found that, in addition to the choice of drug,

patient selection and provider procedures are crucial

to making the level of risk at home comparable to

that in the hospital. Patients who are medically

unstable (e.g., have a very high fever) are not

appropriately discharged from the hospital. In addition, patients who have no supportive family

caregivers, who are unable to understand and

carry out infusion therapy procedures, or who

are unwilling to continue therapy at home are at

high risk of complications and are poor candidates for home care. Provider procedures, such as

performing rigorous patient selection, requiring

special pharmacist and nurse training, carrying

anaphylaxis treatment kits, and requiring 24-hour

on-call pharmacist and nurse availability, minimize

risk. Physician involvement is also critical to the

safe and effective delivery of HDIT services.

The relationship between patient suitability, provider procedures, and medical risk in HDIT warrants

quality assurance efforts on the part of the Federal

Government in the event of Medicare coverage.

Quality assurance efforts should include some level

of case review to monitor instances of possible

poor-quality patient care. They should also include

explicit and stringent conditions of participation that

HDIT providers must meet to receive Medicare

reimbursement. Such conditions can assure that

although some direct patient care services may be

performed under contract, certain functions (e.g.,

initial patient assessment, service coordination,

periodic drug regimen review, clinical recordkeeping, and providing an ongoing and emergency

point-of-contact for patient) remain the responsibility of the “primary” HDIT provider. This “primary” provider is the one that undertakes the

responsibility for coordinating the HDIT and that

subcontracts or arranges with others to provide those

HDIT services it does not provide in-house.

Issues and Options for Medicare

Implications of Medicare Coverage

Substantial numbers of Medicare patients are

currently receiving HDIT, although the exact number is unknown. As described above, OTA estimates

that roughly 20,000 to 35,000 persons age 65 and

over will receive this therapy in 1991, and of elderly

persons the great majority is eligible for Medicare.

In addition, some disabled Medicare beneficiaries

probably receive HDIT

Many of the Medicare beneficiaries receiving

HDIT at present have other insurance (e.g., private

insurance or Medicaid) that presumably pays for the

therapy. However, as described above, despite the

lack of an explicit Medicare HDIT benefit, some

beneficiaries do receive Medicare coverage for some

of the components of HDIT some of the time. The

frost decision regarding Medicare coverage of HDIT

is whether to pass a comprehensive benefit.

Considerations regarding whether an HDIT benefit should be enacted are addressed in option

below. Options 1 through 9 (summarized in table

1-2) then discuss some of the different forms such a

benefit might take. Finally, options 10 through 19

present possible research and demonstration projects that might inform Federal policymakers regarding various aspects of HDIT These options, which

could be implemented in either the presence or

absence of a Medicare HDIT benefit, are summarized in table 1-3.

Option O: Enact a home drug infusion benefit

under Medicare.

Many patients would prefer to receive drug

infusion therapy at home rather than in the hospital,

and when appropriate precautions are in place they

receive good quality care. At present, however,

existing “back door” mechanisms through which

specific components of HDIT are currently covered

result in fragmented and inconsistent coverage in

which there are no qualifications required by Medicare for HDIT providers and no quality control of the

overall set of services received by the patient. Thus,

a Medicare HDIT benefit would offer enhanced

patient benefits compared with the current policy.

The cost implications of extending Medicare

coverage are less straightforward. In the short run,

the addition of this benefit would almost certainly
Chapter 1—Summary and Options . 11

Table l-2—issues and Options for Covering Home Drug Infusion Therapy (HDIT) Under Medicare

Basic Issue: Should Medicare cover HDIT?

Option O: Enact a home drug infusion benefit under Medicare.

(If so:)

issue 1: What routes of drug admlnlstratlon shouldbe covered?

Option 1A: Cover only intravenously administered drugs.

Option 1 B: Cover both intravenous and other routes of parenteral

administration.

Issue 2: What drugs and conditions should be covered?

Option 2A: Cover drugs and conditions specified on a list devised

by the Health Care Financing Administration (HCFA).

Option 2B: Permit fiscal intermediaries to determine specific

covered drugs and conditions, based on general coverage

categories and guidelines from HCFA.

Issue 3: Who should be eligible for the benefit?

Option 3A: Cover only patients who can self-administer their

therapies (after initial instruction) or who have family caregivers to perform this service.

Option 3B: Extend coverage to all patients who can be safely

treated at home, including patients who need assistance with

their infusion-related or other home health care.

Option 3C: Extend coverage to patients who cannot selfadminister, but limit the amount of assistive services such

patients may receive.

Issue 4: Who should be able to provide and bill for HDIT?

Option 4A: For patients needing only HDIT, permit providers of

different components of this therapy (e.g., pharmacy and

nursing services) to bill separately for their respective components.

Option 4B: For patients needing only HDIT, require that a single

certified home infusion therapy provider bill for all services

received by that patient.

Option 4C: For patients needing both infusion and other home

health services, permit a certified home infusion provider and

the home health agency provider to bill separately for their

respective services.

Option 4D: Require that the primary provider for patients needing

both infusion therapy and other home services-i.e., the

provider who coordinates services and submits a bill to

Medicare-be a certified home health agency.

Issue 5: Where should a benefit be placed In Medicare’s

structure?

Option 5A: Make HDIT a Part A benefit.

Option 5B: Make HDIT a Part B benefit.

Option 5C: Make HDIT a benefit under both Parts A and B,

depending on the patient’s circumstance and concordant

benefits.

Issue 6: Should benefit administration be consolidated?

Option 6: Require that the benefit be administered through a few

regional fiscal intermediaries.

issue 7: What level of case review should be required, and by

whom?

Option 7A: Do not require preauthorization for HDIT.

Option 7B: Require Peer Review Organizations (PROS) to

preauthorize some or all HDIT patients.

Option 7C: Require fiscal intermediaries to preauthorize HDIT

patients.

Option 7D: Require PROS to retrospectively review some home

infusion patient claims.

issue 8: How should providers be paid for HDIT?

Option 8A: Pay for the various components of an HDIT benefit

under existing payment mechanisms that apply to home

health, durable medical equipment, and other benefits.

Option 8B: Pay for HDIT on the basis of actual costs, with a cap

on the total costs allowed.

Option 8C: Pay a prospective per-diem rate for HDIT services.

issue 9: How should physicians be paid for HDIT-related

services?

Option 9A. Pay physicians for their additional supervisory time in

HDIT cases on the basis of existing fee-for-service methods.

Option 9B. Pay supervisory physicians a fixed rate (e.g., per

patient or per day) for patients on HDIT.

Option 9C. Do not pay physicians for supervisory and advisory

activities related to oversight of HDIT.

SOURCE: Office of Technology Assessment, 1992.

raise program costs, because Medicare cannot immediately recoup the financial benefits of shorter

hospital stays. In the long run such a benefit could be

cost-saving to the program, particularly if it were

limited to independent patients who, when trained,

needed little additional paid assistance. The benefit

could be cost-raising in the long run, however, if

Medicare were to pay for more costly home care in

order to improve the quality of life during treatment

for beneficiaries who need assistance to receive

HDIT. The extent of long-run cost savings also

depends on the ability of Medicare to bargain for low

rates from providers, and its ability to identify

patients who would be more costly at home and

ensure that these patients are treated in alternative

settings.

Covering HDIT would affect not only the Medicare program and HDIT providers and payers but

also many facilities that are alternative sites of

infusion therapy: skilled nursing facilities (SNFs),

outpatient infusion providers, and hospitals. Outpatient clinics may be more appropriate settings than

acute-care hospitals for some Medicare patients who

need assistance with their infusion therapy, and

SNFs may be more appropriate for many patients

who need other assistive care as well. At present,

however, SNFs have high occupancy rates and few

empty beds, and most SNFs do not usually retain the
12. Home Drug Infusion Therapy Under Medicare

Table 1-3-Options for Conducting Research and

Demonstrations Relating to Home Drug Infusion

Therapy (HDIT)

Clinical studies

Option 11: Provide provisional or augmented coverage for drugs

administered by HDIT providers participating in certain clinical

studies.

Cost studies

Option 12. Examine the resource costs of providing HDIT and the

economic characteristics of the HDIT industry.

Option 13. Examine the relative costs of providing drug infusion

therapy in home and outpatient settings.

Option 14. Examine the use of basic home health services, and

the need for infusion assistance, among elderly patients on

HDIT

Payment studies

Option 15. Examine different potential methods of paying for

HDIT.

Option 16. Examine the feasibility and effects of paying hospitals

less than the full inpatient rate for patients subsequently

discharged to HDIT.

Option 17. Examine alternative methods of paying for drug

infusion therapy in skilled nursing facilities and hospital swing

beds.

Option 18. Examine the effects of an HDIT benefit on rural and

inner-city hospitals.

Quality studies

Option 19: Examine the outcomes of HDIT under various

conditions (e.g., different types of patients and therapies) to

determine which measures might be appropriately used as

indicators of good- or poor-quality care.

SOURCE: Office of Technology Assessment, 1992.

in-house expertise to provide drug infusion therapy.

They may be unwilling to accept drug infusion

patients, or to treat existing patients in the nursing

home, either due to lack of expertise or lack of

reimbursement to cover the expense of intensive

drug therapy.

For hospitals, covering HDIT would lead to lower

payments in the future for some diagnosis-related

groups (DRGs), to account for shorter average

lengths of hospital stays and lower average costs in

these DRGs. Hospitals unable to discharge patients

home (e.g., due to the lack of a qualified home care

provider in the area) would be disadvantaged despite

their best efforts. This disadvantage will be minimized if these hospitals have “swing beds’ ’11 to

which they can discharge patients needing only drug

infusion therapy and associated skilled nursing, and

if they are adequately reimbursed for that care.

If current policies are unchanged, Medicare is

likely to find itself paying for a substantial amount

of HDIT in the future even in the absence of a

defined benefit. Under current DME and home

health rules, the actual coverage is increasing and

will probably continue to do so, as Medicare’s FIs

use their discretion to cover drugs as well as the

associated equipment, supplies, and nursing care.

This coverage, however, will continue to be fragmented, uncoordinated, and inconsistent across areas.

The absence of a coordinated benefit limits the

ability of Medicare to assess, monitor, or influence

the safety, quality, and effectiveness with which

home infusion services are delivered.

Thus, OTA concludes that covering HDIT and

placing defined requirements on providers and

patients is likely to improve the quality of home

care that Medicare patients receive. It may not

save costs, however; to the contrary, it could

easily increase Medicare spending. Program cost

savings are probably more likely if the benefit

places some restrictions on those who can use it.

Coverage Options

If Congress should decide to make HDIT a

Medicare benefit, it must first decide what and who

should be covered. Options 1 through 3 present

possible alternative decisions regarding three coverage issues:

1.

2.

3.

whether coverage should extend beyond IV

administration to other forms of parenteral

drug administration;

what drugs and medical conditions should be

covered and how these coverage decisions

should be made; and

whether patients who need assistance with

their care (and have no family caregiver)

should be eligible

benefit.

Route of Administration

Option 1A: Cover only

tered drugs.

Option IB: Cover both

for the home infusion

intravenously

IV and other

parenteral administration.

adminisroutes of

11 sag beds me ~ute-c~e MS desi~ted by a hospital to provide either acute or long-term care services. Medicine and Medicaid pay fOr care

provided to swing-bed patients in qual@ng rural hospitals.
Chapter 1-Summary and Options ● 13

Most drugs infused at home (e.g., most antibiotics) are administered intravenously. However, depending on the drug and the condition of the patient,

drugs may also be infused into an artery (intraarterially), under the skin (subcutaneously), into the

muscle (intramuscularly), into the abdomen (intraperitoneally), or into the areas around the spinal

cord (epidurally or intrathecally).

In some cases, one of these latter modes of

delivery is used because the drug itself is most

effective, or causes the least complications, if

administered in that manner. In a few cases, a drug

may usually be most effective when administered

intravenously, but a patient maybe unsuitable for IV

therapy (e.g., because the veins are very fragile).

Such a patient might instead get the drug by the next

most favorable route (e.g., subcutaneously) .12

Choosing to cover drugs only if they are administered intravenously (as would have been the case

under the MCCA) has the virtue of applying a rule

that is unambiguous, simple to administer, and

applicable to many of the drugs most amenable to

home therapy (e.g., most antibiotics). Its drawback

is that it will also exclude many drugs and patients

that would otherwise be equally qualified for home

therapy. It would also inhibit the use of drugs that

might in the future be found equally effective and

safer if given by some route other than IV.

In contrast, covering a broad general category of

infused drugs in statute gives much greater latitude

to the Health Care Financing Administration (HCFA)

(or its FIs) to cover drugs delivered by means other

than IV when such coverage is deemed appropriate

at home. The great virtue of this option is its

flexibility and adaptability to future changes in drug

and device technology that make alternative delivery modes attractive. Its drawback is that it could be

interpreted to include a wide variety of drugs and

patients that were not intended to be included in a

benefit. “Infusion,” for example, might be applied

to slowly administered liquid oral medications, or to

drugs administered through a rapid injection as a

one-time ‘‘shot. ’

One strategy to address this drawback would be to

define “infusion” carefully in statute, either by

specifying excluded categories (e.g., fluids administered into the digestive tract) or included categories

(e.g., intravenously and subcutaneously administered fluids injected over a period of at least 10

minutes). A second strategy would be to leave the

definition of “infusion” and the delivery routes it

encompasses up to HCFA.

Drugs and Conditions Covered

Option 2A: Cover drugs and conditions specified

on a list devised by HCFA.

Option 2B: Permit fiscal intermediaries to determine specific covered drugs and conditions,

based on general coverage categories and

guidelines from HCFA.

Drug-level coverage decisions-whether to cover

particular types of drugs for particular conditions or

organisms-can theoretically be made at almost any

level. The potential decisionmakers range from

Congress, which could specify particular drugs in

statute, to physicians, who could be permitted to

prescribe (and receive payment for) any drug for any

condition they deemed appropriate.

Greater levels of regulatory intervention in the

decisionmaking process are associated with both

greater checks on imprudent physician prescribing

and less flexibility to accommodate new, effective

drugs and treatment protocols. The choice of who

should designate the drugs and conditions covered,

therefore, becomes one whose point of compromise

depends on the degree to which one values flexibility at the expense of oversight and consistency.

It is unlikely that Congress would choose to take

upon itself the burden of identifying specific drugs

and conditions to be reimbursed under Medicare. It

is also unlikely that Congress would want Medicare

to pay for all physician prescriptions. Option 2 thus

outlines two intermediate alternatives. Option 2A

exercises the greatest regulatory control, permitting

coverage only for drugs determined by HCFA to be

safe and effective in the home. In option 2B, the

basic decision regarding what drugs are generally

effective when delivered at home is left to the

FIs-those contractors (usually private insurance

companies) who would administer the benefit at the

local or regional level on Medicare’s behalf.

Federal-level decisionmaking would result in the

greatest coverage consistency. HCFA has little

experience in drug evaluation and is not currently

involved in any drug approval process. If HCFA is

IZ Mtemtively, a patient witi fra~e ve~ rni@t have a central catheter surgically implanted to avoid the need for repeated venous puIIctures.
14. Home Drug Infusion Therapy Under Medicare

required to approve drugs for home infusion use,

either the agency must retain additional advisory

personnel who have clinical experience, or another

agency with such expertise (e.g., the Agency for

Health Care Policy and Research, or the Food and

Drug Administration) must be directed to assist

HCFA in thiS task.

Local decisionmaking offers more adaptability

but less consistency across locales (and, thus,

presumably somewhat less equity across patients).

Many FIs already have some familiarity with home

infusion therapy in the context of either their

Medicare or their private business, and they have

medical advisory structures in place. If option 2B is

chosen, administering an HDIT benefit through a

few regionalized FIs might enhance coverage consistency (see option 6).

In addition to (or instead of) covering a basic

defined set of drugs (whether set by HCFA or FIs),

Congress could choose to provide provisional or

augmented coverage for drugs that were part of

specified demonstration projects. This possibility is

discussed in option 11 below.

Patient Eligibility

Option 3A: Cover only patients who can selfadminister their therapies (after initial instruction) or who have family caregivers

trained to perform this service.

Option 3B: Extend coverage to all patients who

can be safely treated at home, including patients who need assistance with their infusionrelated or other home health care.

Option 3C: Extend coverage to patients who

cannot self-administer, but limit the amount of

assistive services such patients may receive.

Many beneficiaries who would prefer HDIT over

hospital infusion might require assistance with their

infusion or other health care needs in order to go

home. However, providing assistive health services

greatly increases the costs of care for a patient on

HDIT, and the extent to which Medicare covers

these services for HDIT beneficiaries would greatly

affect Medicare expenditures.

Under option 3A, Medicare would cover HDIT

only for patients who can demonstrate the capacity

to administer the infusion without the assistance of

a paid caregiver. 13 This alternative would restrict the

benefit to a small number of patients and offers the

surest opportunity to achieve program cost savings.

However, it restricts the ability of disabled homebound patients, or those who (with assistance) might

be able to avoid hospitalization altogether, to receive

HDIT from a professional caregiver.

Under option 3B, any patient meeting basic

medical appropriateness criteria could make use of

the benefit. However, it would permit unlimited use

of assistive home services, no matter how expensive,

unless adjunct policies were also in place to limit

these services.

Option 3C permits any patient to be eligible for

HDIT but restricts the covered benefits that patient

can receive. For example, the HDIT benefit might

include coverage of daily nursing to accommodate

patients with needs for occasional nurse-administered infusions (e.g., up to 10 visits or 20 hours of

home skilled nursing per week). To avoid unwittingly paying for assistive services through the home

health benefit in this example, HDIT patients could

be disqualified from concurrent eligibility for that

benefit. This alternative eliminates the possibility of

paying for home care for patients who need very

extensive services, but it could prevent some patients who currently qualify for home care services

from receiving their infusion at home as well.

Alternatively, the HDIT benefit could be very

limited in its coverage of assistive services but

beneficiaries could be permitted (if they qualified) to

retain home health benefit eligibility at the same

time. Under this scenario, home health coverage for

these dual-coverage patients could be limited to

restrain utilization of assistive services. For example, HDIT patients who were homebound could be

permitted concurrent coverage for home health

services up to a stated maximum limit.14 This

alternative would allow for some assistance while

providing an incentive for home providers to accept

patients only if their anticipated assistive needs were

few. However, it might also result in some underservice or rehospitalization of patients whose assis13 F~~ ~mple, ~ @ySic~m@t & rqfi~ to Ce@ tit the patient or family mem~r could p~orm the ~ion w a prerqukite for eligibility

for the benefit.

14 For emple, coverage for ~oncwmthome h~thben#lts co~d ~ limit~ to a dol~ amo~t CXI@ to some yr~n~ge Of the average per-patient

home health payment in that area.
Chapter 1—Summary and Options . 15

tive needs were eventually greater than originally

anticipated.

Option 3C might be somewhat complex to administer, since it presumes that the FIs involved can

monitor HDIT and home health benefits simultaneously. Its implementation would be most straightforward if both benefits were administered by the same

intermediary so that concurrent benefit eligibility

could be detected easily (see option 5).

Administrative Options

The choice of how an HDIT benefit is to be

administered can be made by Congress, or it can be

left to HCFA to decide. Traditionally, the responsibility for administrative decisions has been primarily the purview of the executive branch of the

government. Some administrative aspects of an

HDIT benefit, however, have broad implications for

the shape of the benefit itself. In these cases,

Congress may want to provide HCFA with either

statutory or nonbinding language to indicate how

HCFA should address these issues.

Options 4 through 7 address some of the major

decisions that must be made regarding administration of a home drug infusion benefit. These include:

1.

2.

3.

4.

how the primary provider responsible for the

home benefit is specified;

whether an HDIT benefit should be placed

administratively under part A or part B of the

Medicare program;

whether the administration of the benefit

should be consolidated under a few regional

Medicare FIs; and

who should conduct appropriate case approval

and review activities.

Provider Designation and Service Integration

Option 4A: For patients needing only HDIT,

permit providers of different components of

this therapy (e.g., pharmacy and nursing

services) to bill separately for their respective

components.

Option 4B: For patients needing only HDIT,

require that a single certified home infusion

therapy provider bill for all services received

by that patient.

Option 4C: For patients needing both infusion

and other home health services, permit a

certified home infusion provider and the HHA

provider to bill separately for their respective

services.

Option 4D: Require that the primary provider

for patients needing both infusion therapy and

other home services-i.e., the provider who

coordinates services and submits a bill to

Medicare--be a certified HHA.

Some Medicare patients will need only HDIT and

no additional assistive services in order to continue

their medical treatment at home. (In fact, under

option 3A above, only these patients would be

eligible for the benefit.) For these patients, Congress

could permit providers to bill Medicare as they

sometimes do other payers, with one or many

providers submitting bills according to the specific

components of therapy they provide.

However, Congress may wish to ensure service

integration and provider accountability by requiring

that a single provider bill Medicare for all HDIT

services provided to that patient. As was the case

under the Medicare Catastrophic Coverage Act, the

primary HDIT provider could be required to meet

detailed criteria, as outlined in regulations, to be

certified as a qualified HDIT provider.

Many Medicare patients medically stable enough

to go home on HDIT, however, may need basic

home health assistive services in order to function in

this setting. Many (if not most) of the major HDIT

providers are not Medicare-certified HHAs and do

not provide basic home nursing, therapy, and home

health aide services. For these patients, Medicare

could permit separate billing by the respective HDIT

and HHA providers (option 4C), with one or the

other required to coordinate the two types of

services; or, Medicare could require a certified HHA

to bill for and coordinate all in-home health services

provided to a given patient, including HDIT (which

might be provided under contract to the HHA)

(option 4D).

The coordination of infusion and other home

health services is an important issue for beneficiaries, providers, and the Medicare program alike.

For beneficiaries, dealing with two separate providers of home care services might mean duplications

and gaps in services, with no single source of contact

for coordinating or discussing the overall care with

the patient. If a single HHA provider is responsible

for both sets of services, coordination of these
16. Home Drug Infusion Therapy Under Medicare

services would be done by that HHA. If separate

HDIT and HHA providers were recognized (as in

option 4C), Medicare might want to require one of

the providers (or an outside case manager) to

undertake the coordination responsibilities.

For providers, permitting separate HDIT and

HHA billing has the advantage of leaving the billing

for a service to that provider with the most background in that service. There would be little need for

HHAs to learn new HDIT-related billing and oversight responsibilities unless they undertook them

voluntarily. Separate billing is preferred by many

HDIT providers, because most are not currently

certified by Medicare as HHAs (and some reportedly

cannot do so because of certificate-of-need laws in

their States that restrict new HHAs).

The Medicare program, on the other hand, might

find single HHA-based billing simpler once HHAs

learned the necessary procedures. Single billing

would also reduce the difficulty of identifying and

avoiding duplicate payment for HDIT and other

home nursing services. Since home health is a Part

A service unless the beneficiary has no Part A

coverage, Medicare Part A intermediaries (rather

than Part B carriers) would be the logical administrators to deal with claims if only HHA single-billing

were permitted. However, this option might require

considerable training of HHAs to familiarize them

with HDIT and the necessary billing procedures.

Note that even if single HHA billing were

required for patients receiving both HDIT and other

home health services, Medicare could still permit

HDIT-only providers to bill for infusion-only patients. In this case, claims might be handled by either

Part A or Part B FIs, depending on the intent of

Congress and the Medicare program (see option 5).

Administrative Placement

Option 5A: Make HDIT a Part A benefit.

Option 5B: Make HDIT a Part B benefit.

Option 5C: Make HDIT a benefit under both

Parts A and B, depending on the patient’s

circumstance and concordant benefits.

The choice of administrative placement for an

HDIT benefit affects who administers it and how

easily it can be integrated with other Medicare

benefits. Medicare Part A generally covers hospital,

SNF?, home health, and hospice care and is administered through one set of FIs. Medicare Part B covers

physician and laboratory services, hospital outpatient and ambulatory surgical services, and DME

and is administered through a separate set of FIs. The

Parts A and B FIs are private insurance companies,

but only rarely does the same company fill both roles

in its given locality.

At present, both Part A and Part B benefits overlap

somewhat with a potential home drug infusion

benefit. Existing home health benefits are usually

under Part A and administered by 10 regional FIs,

but home health services are also a Part B benefit for

beneficiaries not eligible for Part A coverage. (In the

latter case the benefit is still admini stered by the Part

A FIs.) TPN, an existing infusion benefit, is a

prosthetic device benefit under Part B and consolidated under two regional Part B FIs. DME benefits

are usually administered through Part B FIs, but

DME supplied by an HHA as part of the home health

benefit is administered through the 10 Part A home

health FIs. Hospice care, which sometimes includes

home infusion therapy, is a Part A benefit; outpatient

infusion and physician and laboratory services are

Part B benefits.

Thus, the choice of where to place an HDIT

benefit administratively depends in part on how it is

to be integrated with existing benefits. If the benefit

is to be linked with home health benefits, it would be

administratively simplest to place it under Part A. If,

however, it is to be entirely distinct from home

health nursing, it would be simpler to place it under

Part B, where some administrative experience with

reimbursing for the component equipment and drugs

is developing. Finally, it could be administered

under Part A for some patients (e.g., those also

qualifying for home health benefits) and under Part

B for others (e.g., those needing no adjunct services)

(see option 4).

The split of bills for patients receiving infusion

services between Part A and Part B Fls could be

problematic, since it would require all administrative contractors to gain some expertise in handling

infusion claims and would increase variation in that

handling. On the other hand, if home health and

infusion providers were permitted to bill separately,

Medicare might find it difficult to identify duplicate

claims for home health nursing services.

One way to minimize claim-handling variation in

the former case might be by consolidating FIs for the

purposes of administrating this provision (option 6).
Chapter 1—Summary and Options . 17

Fiscal Intermediary Consolidation

Option 6: Require that the benefit be administered through a few regional FIs.

Regardless of whether an HDIT benefit is placed

under Part A, Part B, or both, Congress (or HCFA)

may want to consider consolidating the administration of the benefit under a few regional Medicare

administrative contractors. Such a consolidation has

precedent both under Part A (for home health

benefits) and under Part B (for TPN benefits).

The great advantage of consolidation is that the

few administrative FIs can amass greater experience

in administering the benefit, leading to more consistent coverage decisions, more rapid claims processing, and more information with which to update

coverage decisions or payment amounts. In addition,

the fewer number of administrative organizations

means that the potential for widely varying and

inconsistent coverage policies would be reduced.

The advantage of greater claims experience might be

especially important if the benefit were split between Part A and Part B, depending on the particular

patient and circumstances (see option 5C).

The primary disadvantage of regional FIs is that

the crossing of traditional contractor boundaries

might pose difficulties for peer review organization

(PRO) review, since PROS are located in each local

contractor area. To overcome this disadvantage, the

benefit might need to be overseen by a few regional

PROS, corresponding to the regional intermediaries

or carriers. To date, however, HCFA has relatively

little experience in designating PROS with responsibilities across local contractor lines whose activities

include prior authorizations.

Case Review

Option 7A: Do not require preauthorization for

HDIT.

Option 7B: Require PROS to preauthorize some

or all HDIT patients.

Option 7C: Require FIs to preauthorize HDIT

patients.

Option 7D: Require PROS to retrospectively

review some home infusion patient claims.

A critical element in the safe and effective

delivery of HDIT is patient screening to ensure that

hospital discharge (or, for nonhospitalized patients,

drug therapy) is appropriate. Performing patient

screening is one of the functions of HDIT providers.

If they do it well, Medicare oversight—i.e., preauthorization-of HDIT patients at the onset of home

therapy may not be necessary.

It may be difficult for Medicare to assure itself

that HDIT patients are being appropriately screened,

however, especially in the frost years when there is

little experience with an HDIT benefit. In particular,

Medicare may be justifiably concerned about premature hospital discharge. One detriment to a Medicare

HDIT benefit is the strong financial incentive it

could provide to both hospitals and home care

providers to remove patients from the hospital, even

when home care may be inappropriate or the patient

is unwilling to be discharged. In the case of patients

who are not hospitalized at the time HDIT is

prescribed, Medicare may still wish to be assured

that the patient can be safely treated at home. And in

all cases, Medicare may wish to document who will

be responsible for therapy and assure that the

prescribed infusion therapy meets some basic criteria of medical necessity (e.g., oral drugs are not

effective for the given condition).

There are two logical parties to perform HDIT

preauthorization. First, the FIs who would later

process the claim could conduct the review. Alternatively, PROS could give the preauthorization.

PROS are physician-run private organizations that

contract with Medicare to review the appropriateness and necessity of medical interventions in a

variety of settings, including hospitals. They are

capable of detailed medical assessment and would

probably be the most appropriate reviewers if the

prior review were to involve an extensive discussion

of the patient’s therapy and condition. (The MCCA

required PROS to conduct preauthorization review

of all patients recommended for HDIT. In addition,

HCFA’s proposed regulations required PROS to

approve prescription changes and other alterations

made during the course of therapy, and to conduct

retrospective review of a random sample of HDIT

cases.) The disadvantage of this proposal is that

PROS are poorly organized for quick response (as

would be required where home discharge is imminent), and the extensive review that they are most

qualified to provide is time-consuming, expensive,

and would probably delay patient discharge somewhat.
18. Home Drug Infusion Therapy Under Medicare

FIs, in contrast, have traditionally had relatively

less in-house medical expertise15 but are more

geared to day-to-day decisionmaking and detail. FIs

thus might be more appropriate organizations to

conduct preauthorization if the goal is a less

comprehensive and less expensive check on basic

appropriateness. For example, a FI-based prior

approval mechanism might be simply to tentatively

approve home therapy based on affirmative answers

to a short list of screening questions, with final

approval for payment made retrospectively by

claims personnel on the basis of documentation in

the record for these questions. Since brevity would

be one of the goals of preauthorization in this case,

quick turnaround (e.g., within 24 hours) could also

be a requirement.

If FIs were judged to be the appropriate organizations to conduct prior review, it may still be

desirable for PROS to participate in the development

of the screening questions. Infusion professionals

(e.g., infectious disease physicians, IV specialty

nurses) could also be involved.

Prior authorization of all patients beginning HDIT

may not be necessary, particularly in the long run if

concerns about premature hospital discharge prove

unwarranted. For drugs that are relatively safe (e.g.,

many antibiotics) and for which the indications are

clear, issuing clear instructions to providers and

conducting retrospective review may be sufficient.

Accordingly, in addition to requiring preauthorization of some home care cases, Congress or HCFA

could require PROS to perform a detailed retrospective review of the appropriateness of care of a sample

of claims to identify problems of care.l6 The review

could be a simple random sample of cases (e.g., 10

percent of all claims). The review could be augmented by targeted review of all claims in certain

categories indicative of possible problems (e.g., all

claims associated with a beneficiary complaint; all

claims in which the patient died or was rehospitalized within 30 days after home therapy; all claims

for certain categories of drugs).

Payment Options

The way in which Medicare pays for HDIT would

affect the shape of the industry, the willingness of

providers to offer services to Medicare patients, the

quality of the services provided, and the costs to

Medicare. Options 8 and 9 deal with how Medicare

might pay HDIT providers, whether providers will

be required to accept Medicare assignment to serve

Medicare patients, and the different ways Medicare

might choose to compensate physicians for their

services relating to a course of home infusion

therapy.

Provider Payment Methods

Option 8A: Pay for the various components of an

HDIT benefit under existing payment mechanisms that apply to home health, DME, and

other benefits.

Option 8B: Pay for HDIT on the basis of actual

costs, with a cap on the total costs allowed.

Option 8C: Pay a prospective per-diem rate for

HDIT services.

The potential ways of paying for an HDIT benefit

include both retrospective methods, in which the

amount of payment is determined after the service is

delivered; and prospective payment, in which the fee

is determined before the service takes place. Retrospective methods include cost-based payment (the

current method of paying for home health and

hospital outpatient services) and charge-based payment (which historically has been the method of

paying for DME and physicians’ services). Prospective methods are varied and generally rely on some

form of a fee schedule. Fees maybe established for

each individual item or service, or these services

may be “bundled’ across time into, for example, a

per-diem or per-discharge payment. Fees may either

be set by the payer or be established on the basis of

negotiation or provider competition.

Although any of these methods could theoretically be applied to HDIT, only three are sufficiently

15 Seved Ctitis told OT.A tittheir in-house medic~ expertise has increased over time and is now comparable to that in pROS. OTA k nOt

independently evaluated this claim.

16 Under the MCCA, health maintenance organimations (HMOs) would have been excluded from PRO review for this service. However, HMOS that

provide HDIT may face the same incentives as non-HMO hospitals to discharge patients to home care with inadequate support. Thus, PRO review of

Medicare home infusion patients in HMOS and other capitated plans patients maybe justitled.
Chapter 1—Summary and Options . 19

well developed that they could, if desired, be

implemented immediately. Of these, a method

combining cost- and charge-based reimbursement

would be the simplest to implement. In essence, this

method would simply extend current rules (e.g.,

cost-based payment for home health services and

charge-based payment for drugs, equipment, and

supplies) where they applied and augment the

existing system with refinements where necessary

(e.g., better drug codes, allowances for pharmacy

services). Non-HHA infusion providers might need

to be permitted to bill for nursing (in a manner

analogous to home health nursing visits) when the

nursing visits were for infusion. This method is

easily compatible with a policy that allows different

providers to pay for different components of HDIT.

It would probably have few negative consequences

for quality or access to care, but it also offers the

fewest possibilities for cost control.

All-cost-based reimbursement also offers incentives to provide high-quality, accessible care to

Medicare beneficiaries, but it may be somewhat

inflationary. Placing a capon allowable costs might

reduce cost increases to some extent. All-cost-based

reimbursement would be relatively easy to implement if HHAs were the primary providers, but

HDIT-specialty providers have little experience

with cost reporting. For these providers, this payment method would require some administrative

effort. In any case, this payment method would

probably require that a primary HDIT provider bill

for all HDIT-related services in order for providerspecific Medicare costs to be assessed accurately.

Prospectively set rates (e.g., per-diem rates) for

HDIT have been used successfully by private

insurers, and more information is available to set

rates now than at the time the MCCA was passed.

This method offers the greatest possibility for cost

control, but it could endanger patient access and

quality of care if rates are low and quality of care

cannot be monitored adequately.

If prospectively set rates are chosen as the method

of payment for HDIT, bundling at least nursing

services, supplies, and equipment into a single rate

(or set of rates) may reduce paperwork burdens and

system ‘ ‘gaming. ’ ‘ Continual advances in new

technology and potential tradeoffs between nursing

needs and equipment costs for some technologies

means that, if payment were according to an

itemized fee schedule, Medicare might find it

difficult to keep up with changes in the therapy and

still keep costs under control.

Competitively set prospective rates offer some

advantages over HCFA-designated rates. Since rates

are set according to the market based on provider

bids, the data problems HCFA might otherwise

encounter (e.g., setting rates too high or too low due

to lack of information on provider costs) would be

relatively less important. However, the need to

compete and contract separately in each area of the

country, and the need to monitor quality of care very

closely, might make competitively set rates administratively very burdensome and costly. In addition, if

contracts were awarded to only a few providers, the

market advantage given to these providers might

result in future market concentration. Thus, in later

contracting rounds, there might be fewer providers

bidding for contracts, and higher future payment

rates.

Other payment methods-for example, bundling

the payment for HDIT into the hospital’s DRG

payment—are also possible, but it would be difficult

to implement these methods quickly. Some of these

methods could be tested through demonstration

projects if desired (see below).

Regardless of the payment method chosen, Medicare might want to take measures to limit beneficiary

liability for charges greater than what Medicare

pays. Private insurers have successfully implemented ‘preferred provider’ programs, under which

providers agree to meet quality standards and accept

the insurer’s payment rate as payment in full, in

exchange for the likelihood that more of that

insurer’s patients will use the provider’s services. A

similar program requiring mandatory assignment for

HDIT providers serving Medicare patients would

reduce patients’ risk of being billed for charges in

excess of the Medicare payment rate. A lack of

providers willing to participate could be one indicator that Medicare payment rates were set too low.

Physician Reimbursement

Option 9A: Pay physicians for their additional

supervisory time in HDIT cases on the basis of

existing fee-for-service methods.

Option 9B: Pay supervisory physicians a fixed

rate (e.g., per patient or per day) for patients

on HDIT.
20. Home Drug Infusion Therapy Under Medicare

Option 9C: Do not pay physicians for supervisory

and advisory activities related to oversight of

HDIT.

OTA found that active physician participation in

a patient’s home infusion care enhances the quality

of that care and may help prevent potential untoward

effects. In the hospital, physician involvement takes

the form of frequent (usually daily) visits, each of

which is often separately billable to Medicare. For

patients in home care, however, physicians face

substantially fewer opportunities to bill for services.

Patients have fewer billable physician visits, while

physicians spend time monitoring and adjusting

therapy outside of visits and consulting with pharmacists, nurses, and patients over the telephone.

None of these latter activities are currently reimbursable under Medicare.

Some physicians and home infusion providers

have devised compensation mechanisms to counteract the financial disincentives related to payer

policies. Some infusion providers, for example,

reputedly pay physicians “consulting fees” in

exchange for referrals. In other cases, physicians are

co-owners of an infusion provider and thus share in

profits that arise from referring patients to that

provider. These arrangements may arise out of a

legitimate desire to influence the quality of care

provided and to receive some kind of reasonable

compensation for the physician services associated

with home care. Nonetheless, physicians have a

virtual monopoly on referrals to HDIT providers.

Physician compensation that is linked to the patient

utilization of a particular provider introduces the

possibility that physicians will refer patients to a

higher-cost or lower-quality service in order for that

physician to receive financial benefits. Even in a

more benign form, physicians may be less active in

seeking out the best provider for their patients when

they share in the profits from a referral.

Medicare can, if it wishes, prohibit physicians

who are co-owners of an HDIT provider from

receiving payment, and existing Medicare antikickback provisions prohibit payment where physicians gain a fee for referral. If these forms of

compensation are banned, however, many physicians will continue to be financially penalized for

referring patients to home care. To avoid such a

penalty, Medicare could pay physicians more comprehensively for the services they provide to HDIT

patients.

Although there are many possible permutations

on physician payment, one possibility is to permit

physicians to bill for the time they spend in certain

activities relating to overseeing the care of HDIT

patients. Under this option, for example, physicians

might be permitted to bill for the time spent in

telephone consultation during a patient’s course of

home therapy. The advantage of this option is its

simplicity and compatibility with current billing

methods. Its primary disadvantage is its ‘‘blank

check’ characteristic; there are few ways to confirm

that the time billed was actually spent on issues

relating to a particular patient’s HDIT. This option

also sets a precedent for billing for telephone

services and home care oversight generally, which

could substantially increase Medicine costs.

A second option is to pay physicians a flat fee for

the management of patients on HDIT. This fee could

be a nominal one intended to cover only the average

costs of oversight time exceeding what would be

normally expected of a home care patient. Alternatively, the fee could be intended to cover all

physician services relating to the infusion therapy

during the course of therapy, including office and

home visits. The amount could be set per day or per

episode of therapy; it could vary depending on the

type of therapy, the expected or actual duration of

therapy, or other factors. There is a precedent for

such a payment method; under the Medicare EndStage Renal Disease program, physicians overseeing the dialysis treatment receive a flat monthly fee

per patient. Additional billing is permitted for

services performed for unrelated conditions (e.g.,

treating a broken arm).

A potential drawback of a flat comprehensive fee

(rather than a daily fee) is the financial incentive to

underprovide services. Under a comprehensive fee,

fewer visits do not bring commensurately less

revenue. Medicare could choose to assume that this

problem would be minimal due to physicians’

desires to provide good care to their patients, and

their desire to avoid legal liability for poor care. Or,

Medicare could set a mandatory minimum number

of visits to ensure at least a basic level of service.

Fees could vary depending on the type of therapy

involved and whether the patient was on multiple

therapies under the direction supervision of several

physician specialists.
Chapter 1—Summary and Options .21

Research and Demonstration Options

A great many things that Medicare might want to

know about HDIT are unknown or the subject of

controversy. Areas of uncertainty range from clinical questions about the use of specific therapies in

the home to questions about the needs of elderly

HDIT patients and questions of costs and payment

for HDIT. Many of these uncertainties could be

addressed through specific research or demonstration projects aimed at investigating the particular

issue.

Options 11 through 19 present examples of

possible studies. Although this list is by no means

exhaustive, it includes some of the major areas of

controversy or uncertainty in which the findings

could have a significant effect on the policies

Medicare might choose to pursue. These projects

could be undertaken to refine an existing basic HDIT

benefit that had already been put in place. Alternatively, demonstration projects could predate a benefit, with the findings used to determine the shape of

a later national HDIT Medicare policy.

Clinical Studies

Option 11: Provide provisional or augmented

coverage for drugs administered by HDIT

providers participating in certain clinical studies.

Medicare does not usually cover experimental

drugs or procedures. Given the uncertainty about

home use even for some drugs commonly used in

hospitals, however, Medicare could choose to develop a framework to investigate drugs for their

appropriateness in HDIT and their eligibility for

Medicare coverage in that setting.

For example, Congress could authorize provisional coverage for drug infusion therapies for which

insufficient evidence on home use in the Medicare

population exists, but for which there are a priori

reasons to think that the drug is likely to be effective

in this setting and this population. Provisional

coverage could be limited to drugs that had already

received Food and Drug Administration (FDA)

approval for use in the hospital, and participation in

an organized research protocol (with enhanced data

collection) that had been approved by HCFA could

be required of providers for reimbursement during

the provisional period. Such studies could gather

economic as well as clinical information.

Congress could also choose to authorize provisional coverage for some projects involving drugs

with greater clinical uncertainties. Such projects

might be used to address the relative effectiveness of

an approved drug for a new use that was likely to be

long-term and applicable to the home setting. For

example, a project might provisionally cover dobutamine while collecting and examining the evidence

that this drug actually does improve health when

used as an intermittent long-term therapy. This type

of project involves greater potential for provisionally funding drugs that will eventually be proven

ineffective, however. Congress might wish to distinguish between studies of drugs that have previously

been proven effective for a particular use in the

hospital, and those for which effectiveness for the

use itself is still in doubt.

Cost Studies

Option 12: Examine the resource costs of providing HDIT and the economic characteristics of

the HDIT industry.

An important problem in determining an appropriate method and level of Medicare payment for

HDIT is that the true costs of providing HDIT are

unknown. Existing studies of the “costs” of HDIT

often rely on provider charges to estimate costs.

However, charges (i.e., provider-assigned prices)

and costs (the true resource costs faced by the

provider) are by no means the same and may vary

across therapies, patients, and providers. Differences

in provider-specific costs would be especially useful

for Medicare to understand, so that payment rates

can accommodate those differences where desired

without unnecessarily increasing Medicare expenditures.

Option 13: Examine the relative costs of providing drug infusion therapy in home and outpatient settings.

Although the focus of this report is home therapy,

drug infusion therapy is also sometimes provided in

outpatient clinics. Proponents of outpatient therapy

argue that it enables better quality control, greater

physician involvement, and greater economic efficiencies because there is no need to send a nurse to

every patient’s home. If these arguments are valid

for at least some patients and providers, Medicare

may want to be especially careful not to put in place

an HDIT benefit that would unintentionally discourage patients from outpatient infusion therapy where
22. Home Drug Infusion Therapy Under Medicare

it is available. Understanding the relative costs and

uses of outpatient and home therapy would help

inform such a policy.

Option 14: Examine the use of basic home health

services, and the need for infusion assistance,

among elderly patients on HDIT.

As mentioned above, an HDIT benefit could be

limited to patients who (with family caregiver

assistance) were capable of self-care. Many other

beneficiaries, however, might also prefer HDIT to

institutional treatment. A major question for Medicare is the extent of this potential demand, the

characteristics of the patients who would use adjunct

services, and the costs of the home health services

involved.

A demonstration project could examine this

question either generally or for one or more groups

of beneficiaries of particular interest to Medicare.

Groups of potential interest, for example, might be

homebound beneficiaries currently receiving home

health services who develop a need for infusion

therapy; patients needing help with the actual

infusion but no other home health assistance; and

patients for whom it is anticipated that inpatient

hospitalization for drug therapy could be avoided if

HDIT and other home health services were available.

Payment Studies

Option 15: Examine different potential methods

of paying for HDIT.

Although cost- and charge-based payment methods could be applied to HDIT with relatively modest

administrative effort, other methods are more difficult or rely on less certain information. Per-diem

methods, for example, are feasible at present, but the

information on which appropriate rates could be

based is scanty. A demonstration project testing a

preliminary rate for its effects on provider participation and quality of care would add greatly to that

information base. Other payment methods that could

be tested include:

●

●

competitive bidding methods;

per-diem methods in which components were

“bundled’ in various ways (e.g., the per-diem

rate might include or exclude such items as

DME, nursing services, pharmacy services, and

laboratory services);

●

●

per-patient prospective payment methods based

on episodes of care; and

hospital-based payment, in which the hospital

might receive the HDIT payment as a DRG

add-on and be responsible for providing or

arranging for all care, whether inpatient or

outpatient.

Option 16: Examine the feasibility and effects of

paying hospitals less than the full inpatient

rate for patients subsequently discharged to

HDIT.

A major barrier to Medicare program savings in

the first years of an HDIT benefit is the fact that

hospitals are entitled to receive the full DRG-based

payment for all patients in that DRG, even if a

patient is discharged to HDIT after a few days. One

possible solution to reduce expenditures would be to

pay hospitals less than the full DRG amount for

patients discharged to HDIT. For example, if the

discharge destination on a patient’s hospital bill is

recorded as HDIT, the inpatient stay might be treated

as a transfer, with the “transferring” hospital

receiving a prorated amount depending on the actual

inpatient length of stay.

A philosophically troublesome aspect of such a

“transfer” policy is that it contradicts the basic

theoretical structure of Medicare’s hospital payment

system, which is intended to reward hospitals that

behave efficiently (e.g., by discharging patients

quickly). In addition, the actual effects of such a

policy on hospital discharge behavior and Medicare

expenditures are unclear. For example, hospitals

might simply encourage physicians to discharge

such patients only at the point where the hospital had

recouped the full DRG payment. On the other hand,

such a policy might have some effect on expenditure

reduction even in the event of such hospital behavior.

Option 17: Examine alternative methods of paying for drug infusion therapy in SNFs and

hospital swing beds.

Where patients are medically stable but need

continual supervision or substantial assistive care in

addition to their drug infusion therapy, institutional

care that is less intensive than hospital inpatient care

may be the most appropriate and least expensive. At

present, however, there appear to be considerable

staffing-related problems and some financial disincentives to providing drug infusion therapy in SNF
Chapter 1—Summary and Options .23

and swing-bed settings. Other methods of paying for

such therapy in these settings warrant investigation.

Option 18: Examine the effects of an HDIT

benefit on rural and inner-city hospitals.

If an HDIT benefit is put in place, most hospitals

will be able to discharge relevant patients to a home

care provider in their area. These hospitals will

benefit financially by doing so, because they receive

the full DRG payment for each patient regardless of

the actual length of the inpatient stay.

Some hospitals, however, may not be able to

discharge patients easily. Some rural hospitals, for

example, may be located in areas with no qualified

HDIT provider. Inner-city hospitals may serve

patients who live in high-crime areas that local

providers may be unwilling to serve. Thus, it is

possible that hospitals in these categories may be

financially disadvantaged, through no fault of their

own, by their inability to discharge patients to HDIT

and lower their costs. A study of hospitals that are

potentially at risk of being disadvantaged could

determine whether Medicare policies needed to

accommodate this factor.

Quality Studies

Option 19: Examine the outcomes of HDIT under

various conditions (e.g., different types of

patients and therapies) to determine which

measures might be appropriately used as

indicators of good- or poor-quality care.

Medicare’s ability to monitor the quality of care

provided under an HDIT benefit is crucial. Participating providers, for example, might be required to

show that their record on care quality was acceptable

before being able to renew their Medicare certification. Indicators of poor quality could be used to

screen cases for more in-depth retrospective review.

And certain payment systems, particularly prospective payment systems with fixed rates, include

incentives to underprovide care, making Medicare’s

ability to detect and censure poor-quality care even

more critical.

Despite their importance, measures of the quality

of HDIT are not well-studied and reported in the

literature. Examples of measures that deserve study

include:

●

●

●

●

average complication rates (e.g., the rate of

catheter-related infection) among different types

of patients and therapies;

differences in complication rates, rehospitalization rates, and other factors that are related to

different drug delivery systems (e.g., whether

patients on simple gravity drips experience

more complications of therapy than patients

using more sophisticated infusion devices);

the different factors that affect patient satisfaction with therapy; and

whether provider-specific factors (e.g., contracting v. providing in-house services) are

consistently related to other possible quality

measures.

Because HDIT technologies have been changing so

rapidly, even professional associations that establish

care standards (e.g., the frequency with which

catheters should be changed to avoid infection) are

hard-pressed to keep their recommendations in pace

with technological change.

The Federal Government could fund studies to

examine various outcome measures to determine

which measures can most appropriately be used to

monitor the quality of HDIT care provided to

Medicare beneficiaries. Such studies could be done

in conjunction with a new HDIT benefit or as part of

a larger demonstration study of HDIT.
Chapter 2

THE SAFETY AND EFFECTIVENESS OF

HOME DRUG INFUSION THERAPY
Contents

Page

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Considerations in Oral v. Parenteral Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Routes of Parenteral Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Conditions Treated With HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

The Safety of HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Considerations and Risks of Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Factors Affecting Complication Rate and Severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Relative Risks: Home v. Hospital Drug Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . 34

The Effectiveness and Use of HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Antineoplastic Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Analgesics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Other Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Emerging Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Tables

Table Page

2-1. Some Characteristics of Common Routes of Drug Administration . . . . . . . . . . . . . . . . 30

2-2. Relative Prevalence of Conditions Treated With Home

or Outpatient Intravenous Antibiotic Therapy in Two Programs . . . . . . . . . . . . . . . . . . . 31

2-3. Potential Complications of Intravenous Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

2-4. The Home Drug Infusion Market, 1989 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2-5. Percentage of Intravenous Antibiotics Used in Home Treatment

in Two States, 1989 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2-6. Complications of Infusion Therapy Reported by One Home Infusion Provider . . . . . 36

2-7. Toxicity of Antineoplastic Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

2-8. Examples of Special Considerations in Administering Intravenous (IV)

Antineoplastics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Chapter 2

THE SAFETY AND EFFECTIVENESS OF

HOME DRUG INFUSION THERAPY

Overview

Introduction

There is no well-established or formal definition

of home drug infusion therapy (HDIT). In this

report, HDIT describes treatment that consists of

prolonged (or continuous) injections of drugs that

are administered in the home, usually repeatedly.

Spurred by public- and private-sector policies that

have encouraged alternatives to hospital inpatient

care, HDIT has become a widespread mode of

therapy affecting hundreds of thousands of people.

Market analysts have estimated that between 1986

and 1990 alone, the number of patients treated

outside the hospital with drug infusion therapy grew

from approximately 39,000 to between 200,000 and

225,000 (275,289). These numbers may overestimate the number of patients actually treated at home,

since they probably include some patients treated in

outpatient clinics.

HDIT encompasses an increasingly wide variety

of specific drugs and therapies, each with its own

characteristics and considerations. Accordingly, this

chapter describes how the drugs used in HDIT are

delivered, the patients who use this therapy, the

drugs they use, and the safety and effectiveness of

those drugs when infused in the home.

Properly speaking, HDIT should include only

drug therapy. In this report, however, it is often also

used for the sake of simplicity to include some

therapies other than drugs (e.g., hydration and blood

transfusions) that are not usually covered by Medicare when administered in the home. Another related

therapy, total parenteral nutrition (TPN), is currently

covered; it is discussed in this report only as a

separate form of infusion therapy and is not considered part of HDIT.

●

Summary of Conclusions

Most prescriptions for HDIT are for antiinfective drugs. However, the mumber and

variety of drugs that are being infused in the

home are large and increasing.

-27-

●

●

●

In general, HDIT can be provided safely and

effectively if adequate precautions are taken

against side effects of the therapy and potential

adverse drug reactions. The safety and effectiveness in any given situation, however, depends critically on the particular drug and the

condition of the patient receiving it. The safety

and effectiveness of anti-infective drugs in

individuals who are healthy in all respects

except the infection being treated are wellestablished. Therapies used in patients with

cancer and acquired immunodeficiency syndrome (AIDS) are also well-established, but

their use in the home requires special caution

because of the disabilities of the patients

treated, the multitude of therapies these patients

may require, and the potential toxicity of many

of the drugs they receive.

The ability to deliver infused drugs safely in the

home HDIT has enabled the use of therapies in

ways that might rarely have been tried if,

instead, the patient had to be continually

hospitalized. HDIT thus can sometimes make

new, more powerfully effective drug protocols

more attractive to try. However, it also may

encourage the rapid transfer of new drugs and

new protocols into the relatively unmonitored

home setting without a thorough testing of their

effectiveness in this setting or an appreciation

of their costs. Dobutamine, for example, is

being infused at home despite evidence suggesting that long-term therapy increases mortality rates in some patient groups. Immune

globulin infusion is likewise a small but

growing home technology whose effectiveness

has been documented in a few cases but whose

actual uses are expanding extremely rapidly

and whose costs may be extremely high.

Even among well-established home infusion

therapies, questions exist that can probably

only be answered by research and experience

that involve home patients. For example, despite the fact that most HDIT in the United

States involves drugs administered intravenously, recent studies from Europe and Britain
28. Home Drug Infusion Therapy Under Medicare

suggest that some therapies (e.g., pain management, heparin, immune globulin) may be administered more simply, safely, and effectively

subcutaneously.

Drug Administration

Considerations in Oral v. Parenteral

Administration

From both the patient’s and the physician’s

perspective, the most desirable route of administration is the one that is easiest, most effective, and

poses the lowest risk of side effects and potential

complications. Oral administration often fullfills

these criteria and is the route of choice for most

drugs. Sometimes, however, oral administration is

inadequate or inappropriate, necessitating parenteral drugs (i.e., drugs not administered into the

digestive tract). Factors that can lead to a preference

for parenteral over oral administration include the

drugs’s absorption and metabolic characteristics, its

side effects, its predictability, and the condition of

the patient.

Drug Absorption

To perform their intended functions, drugs must

be delivered to the relevant tissues of the body.

Orally administered drugs are first absorbed from

the digestive tract and then carried in the blood to the

tissues. The absorption of drugs from the digestive

tract is highly variable. Some drugs (e.g., aspirin) are

almost completely absorbed into the blood. Others,

such as the aminoglycosides (a class of antibiotic),

pass through the entire digestive system with less

than 1 percent absorption (129).

Drugs that are not adequately absorbed cannot

attain blood levels sufficient to treat the particular

condition and must, therefore, be administered

parenterally. The factors that determine the absorption of a particular drug include its physical and

chemical properties (e.g., its volubility), the presence of other substances in the digestive tract, the

relative acidity of the digestive tract, and the time it

takes the stomach to empty (11).

Even if a particular drug is eventually completely

absorbed, the rate of absorption may be too slow to

produce a therapeutic concentration in the blood

(i.e., the concentration that is necessary to treat that

condition). Or, the absorption rate may be so rapid

that high concentrations of the drug cause adverse

reactions (11).

Drug Metabolism

The degree of metabolism that a drug undergoes—

i.e., its biological decomposition-also influences

the route of administration. While many drugs can

be given orally with little loss of biologic activity,

others are metabolized by digestive enzymes and

their potency either reduced greatly or lost entirely.

Human immune globulin, for example, is a

naturally occurring substance composed of antibodies produced by a particular kind of white blood cell.

Immune globulin has been used to supplement the

deficiency of normal antibodies in certain individuals with rare diseases (e.g., severe combined immunodeficiency syndrome) whose bodies are unable to

manufacture their own (54). If given orally, immune

globulin would be digested and biologically destroyed. Consequently, it must be administered

parenterally in order to retain its function.

Side Effects

Many drugs can be administered effectively either

orally or parenterally, but the side effects they

produce may vary depending on the route of

administration. Orally administered drugs often can

cause nausea and vomiting, which limit the amount

of that drug that can be given by mouth.

Methotrexate, for example, can be given either

orally or intravenously-i. e., directly into a vein.

When used in small doses to treat diseases such as

psoriasis and rheumatoid arthritis, oral methotrexate

is usually well-tolerated and has minimal side

effects (216). When used as an antineoplastic agent

to treat certain cancers, however, the dose of the drug

that is required to be effective would produce severe

digestive upset if administered orally. Thus, for this

use it is usually administered intravenously.

Predictability of Parenteral Administration

Parenterally administered drugs are subject to far

less variability of absorption than oral drugs, and the

amount of delivered drug that reaches therapeutic

concentration is far more predictable. Consequently,

drugs that have a narrow ‘therapeutic window,’ the

range in which a drug is effective but does not

produce toxic effects, are often administered parenterally so that the amount absorbed can be better

controlled. In addition, intravenously administered

medication is essentially completely absorbed, be-
Chapter 2—The Safety and Effectiveness of Home Drug Infusion Therapy .29

cause it goes directly into the blood. This characteristic usually leads not only to more predictable but

to higher drug levels than those produced by any

other route.

Erythromycin, for example, is a common antibiotic used to treat a variety of infections. After a

single oral dose of 500 mg, peak concentration of

active drug in the bloodstream ranges from 0.3 to 1.9

ug/ml, depending on the particular preparation used.

The same 500-mg dose administered intravenously,

however, results in a peak blood level of approximately 10 ug/ml, a level 5 to 30 times greater than

that obtained by oral administration (129).

Patient Condition

The choice of oral v. parenteral administration

depends not only on the characteristics of the drug

but also on the condition for which it is being used.

Urinary tract infections, for example, are usually

susceptible to oral antibiotics, while bone infections

are not. In the past, parenteral administration has

been the only feasible way of administering sufficient antibiotic to achieve adequate concentrations

of the drug in the bone. A recently developed class

of antibiotic, however, the fluoroquinolones, can

now be used orally to treat some bone infections

(125).

A patient’s physical condition can also affect the

route of drug administration. A patient with oral

cancer, for example, may be unable to swallow oral

analgesics and may require parenteral narcotics even

for mild to moderate pain (37).

Routes of Parenteral Drug Administration

Most commonly, drugs that cannot be administered orally and must be infused over a period of time

are administered intravenously. For certain drugs,

however, or for patients in whom access to the vein

is for some reason compromised, drugs may be

infused into the body through other routes. Some

antineoplasticl drugs, for example, may be infused

into an artery (intraarterially), which carries the

drug directly to the site of the tumor. Intraperitoneal

drugs, administered into the peritoneal (abdominal)

cavity, are also occasionally used for certain cancers.

Drugs used to manage pain in terminal cancer may

be infused in the epidural or intrathecal spaces

surrounding the spinal cord, where they are absorbed

directly into the central nervous system. Some drugs

may be infused under the skin (subcutaneously)

rather than by other routes, either because the drug

is best absorbed that way, because of a reduced risk

of serious infection, or because the patient’s veins

are not adequate to sustain venous infusion.

As with the choice of oral v. parenteral drugs, the

choice of which parenteral route of drug administration to use depends heavily on the characteristics of

the drugs and its limitations (table 2-l). For example, some drugs (e.g., many antibiotics) are effective

when given either intravenously or intramuscularly

(injected into the muscle). Intramuscular injection,

however, can cause severe pain and discomfort if the

drug must be administered gradually, frequently, or

in large doses. In such cases, intravenous (IV)

administration is usually preferred.

The preferred route of parenteral administration

can change over time with new evidence. Two recent

reports, for example, suggest that heparin-usually

administered intravenously when used as extended

therapy for deep-vein thrombosis2-can be safely

and effectively administered subcutaneously as well

(165,271). Furthermore, one of these reports suggests that subcutaneous administration reduces the

need for continual laboratory monitoring and dose

adjustment, enhancing the drug’s attractiveness for

home use (271).

Conditions Treated With HDIT

Individuals on HDIT may be treated for any of a

wide variety of diverse medical conditions, ranging

from high-risk pregnancy to congestive heart failure.

The most common conditions treated with HDIT,

however, fall into three general categories: infections, cancer, and AIDS. Each of these conditions

and the home infusion therapies that may be used to

treat it are described below.

Infections

The classic candidate for HDIT is the patient who

has an infection requiring a long course of IV

antibiotics, but who has no other complicating

conditions. These patients are likely to have two of

the characteristics that allow for home IV administration and make this form of drug delivery an

1 Antineoplastic drugs act against cancerous tumors.

z ~Pveti ~om~sis is tie fomtion of a clot in a b vein of the ti or extremities, Mbit@ blood flow.
30. Home Drug Infusion Therapy Under Medicare

Table 2-l-Some Characteristics of Common Routes of Drug Administration’

Route Absorption pattern Special utility Limitations and precautions

Oral ingestion .

Intravenous .

●

Subcutaneous .

●

Intramuscular .

●

Variable, depends on many ●

factors

●

Absorption circumvented ●

Potentially immediate effects ●

●

Prompt (from aqueous solution) ●

Slow and sustained (from

repository preparations)

Prompt (from aqueous solution) .

Slow and sustained (from

repository preparations)

Most convenient and

economical

Usually safer than other

methods

Valuable for emergency use

Permits titration of dosage

Suitable for large volumes and

for irritating substances, when

diluted

Suitable for some insoluble

suspensions and for

implantation of solid pellets

Suitable for moderate volumes,

oily vehicles, and some irritating

substances

●

●

●

●

●

●

●

●

●

Requires patient cooperation

Availability potentially erratic and

incomplete for drugs that are poorly

soluble, slowly absorbed, unstable, or

extensively metabolized by the liver

Increased risk of adverse effects

Must inject solutions slowly, as a rule

Not suitable for oily solutions or insoluble

substances

Not suitable for large volumes

Possible pain or necrosis from irritating

substances

Precluded during anticoagulant

medication

May interfere with interpretation of

certain diagnostic tests- (e.g., creatnine

phosphokinase) . , r

Wther routes include topical, transdermal, otic, sublingual, buccal, intranasal, rectal, occular, intraarterial, epidural, and intrathecal.

SOURCE: Adapted from A.G. Gilman, L.S. Goodman, R.W. Rail, et al., Goodman and Gihnan’s The Phannaco/ogica/ 6asis of 7herapeufks (New YorlG NY:

McMillan Publishing Co., 1985).

attractive alternative. First, many of these patients

have stable medical conditions and require little

additional medical attention besides their course of

antibiotics. Second, as discussed later in this chapter, most IV antibiotics are relatively free from

serious side effects and adverse reactions, making

them less dangerous than other IV therapies. Consequently, antibiotics and other anti-infectives make

up about two-thirds of the HDIT market (34).

Osteomyelitis (infection of the bone) was one of

the earliest conditions to be treated at home with IV

antibiotics (see, e.g., 16). This condition occurs

when bacteria invade the bone, such as after a

compound fracture that opens the broken bone to the

outside environment. Long courses of therapy with

high concentrations of antibiotics are often required

to treat this condition; treatment of 4 or more weeks

duration is common (106,148,325). In published

studies of home and outpatient IV antibiotic use,

high proportions of the patients studied-over half

in some reports-had osteomyelitis (16,136,148,267).

The condition remains a popular one for treating

with outpatient or home antibiotics. A recent report

of drug infusion therapy in one large outpatient

practice found that 32 percent of the patients treated

had osteomyelitis (340).

Cellulitis (infection of the skin and surrounding

tissue) is another condition frequently treated with

home IV antibiotics. This condition, often found in

persons with impaired immune systems, can result

when bacteria enters a break in the skin and the

body’s immune system is unable to fend off the

invading organisms. Persons with diabetes, for

example, often have poorly functioning immune

systems, and even a minor local infection can

develop into a life-threatening problem. Other infections sometimes treated with home IV antibiotic

therapy when oral drugs are insufficient include

respiratory infections (e.g., pneumonia and bronchitis), urinary tract infections, pelvic inflammatory

disease, and endocarditis (infection of the heart

valves). Examples of the relative prevalence of these

conditions in programs that treat patients with home

or outpatient IV antibiotics are presented in table

2-2.

The relative prevalence of conditions treated

varies considerably among providers. For example,

in contrast to the two programs represented in the

table 2-2, the National Alliance for Infusion Therapy

reports that in a sample of its members, Lyme

disease (which was not even separately listed in the

reports of the programs represented in table 2-2)

accounted for 13 percent of patients treated with

antibiotics (256).

Sometimes, IV antibiotics are used to combat

repeated infections in persons with underlying

disorders that predispose them to these diseases.

Persons with cystic fibrosis, for example, are espe-
Chapter 2—The Safety and Effectiveness of Home Drug Infusion Therapy ● 31

Table 2-2—Relative Prevalence of Conditions Treated

With Home or Outpatient Intravenous Antibiotic

Therapy in Two Programs

Percent of patients with condition

Type of infection Poretz, 1989 Tice, 1991

Bone and joint.. . . . . . . . . 38 41

Skin/skin structure . . . . . . 22 18

Respiratory . . . . . . . . . . . . 13 2

Urinary tract . . . . . . . . . . . 8

Endocarditis . . . . . . . . . . . 2 :

Gynecologic . . . . . . . . . . . 3 19

Other . . . . . . . . . . . . . . . . . 12 16

Total . . . . . . . . . . . . . . . 100’ 100

aTotal may not add to exaetly 100 due to rounding.

SOURCES: D.M. Poretz, “Home Management of Antibiotic Therapy,”

Current Clinical Topics in infectious Diseases 10:27-42, 1989;

A. D. Tice, “AnOffice Model of Outpatient Parenteral Antibiotic

Therapy,” Reviews of Infectious Diseases13(Suppl2):S184-

8, 1991.

cially susceptible to certain respiratory infections

(64). Traditionally, these individuals required frequent hospitalizations to treat the infections. A

number of studies published since the mid-1970s,

however, have documented safe and effective home

treatment of cystic fibrosis patients with IV antibiotics (128,290,328,400).

More recently, investigators have begun testing

prophylactic (i.e., preventive) IV antibiotic regimens for persons with cystic fibrosis (88,102). The

long-term effectiveness of these regimens in preventing infections, however, is still uncertain.

Cancer

Individuals with cancer make up another large

group of patients utilizing HDIT. Many cancer

treatment protocols require frequent administration

of antineoplastics, toxic antitumor drugs that must

be delivered directly into the bloodstream due to

their inherently caustic properties. One of the

therapeutic regimens for metastatic3 breast cancer,

for example, involves the continuous infusion of

vinblastine, an antineoplastic drug, every 3 weeks

for a 5-day period (1 16). Rather than returning to the

hospital for each successive round of treatment,

some patients on this (and other) protocols are

receiving their treatment in the home. The particular

antineoplastic that is used, more than the type of

cancer being treated, determines the appropriateness

of home IV use (35).

Unlike patients with simple infections, cancer

patients may receive a number of different infusion

therapies simultaneously. In addition to antineoplastics, persons with cancer may at sometime during the

course of their disease receive:

parenterally administered narcotic analgesics

to relieve severe pain;

TPN or hydration4 to help to minimize the

anorexia and physical deterioration caused by

the disease and by the drugs used to treat it;

blood transfusions necessitated by the anemia

that results from both the therapy and the

underlying disease;5 and

IV antibiotics to combat infection. (The suppression of bone marrow that results in anemia

also makes cancer patients susceptible to infection).

All of these therapies are sometimes administered

at home. In addition, the patient may receive other

drugs, such as antinausea drugs, that are administered as periodic rapid injections (rather than as slow

infusions).

AIDS

Like persons with cancer, those with AIDS often

require a multitude of parenteral therapies to combat

the disease and the secondary effects of some of the

medications used to treat it. Characteristic infusion

therapies that might be administered in the home

include:

. Anti-infective drugs such as gancyclovir (an

antiviral agent) and amphotericin (an antifumgal drug) to treat opportunistic infections;

● TPN to maintain in adequate weight and nutrition;

and

. Blood transfusions to treat the anemia that

results from both the underlying disease and the

3 Metas~tic dis~e is the sp~d of a malignant cancer to distitp- Of the body.

4 TPN (total parenteralnutrition) is the administration of nutrients directly into the bloodstream. Hydration is the adrmms “ “ trationof simple fluids (e.g.,

dextrose solutions).

5 Antineoplastic drugs act by inhibiting the growth of rapidly dividing cells, such as those in the tumor. However, they also inhibit the division of

normal cells that divide rapidly, such as the blood preeursor cells in bone marrow, causing anemia (a lack of red blood cells). The cancer itselfean also

enter the bone marrow and inhibit normal growth in these cells.
32. Home Drug Infusion Therapy Under Medicare

drugs used to treat it.6 Azidothymidine, for

example, was until very recently the only drug

approved by the Food and Drug Administration

(FDA) to treat the infection that causes AIDS.

A major side effect of this drug, as with

antineoplastic drugs, is its toxic effect on the

blood precursor cells in bone marrow. Gancyclovir and amphotericin also produce anemia.

Pain medication and adjunct injectibles, such as

antinausea drugs, are also sometimes used by

individuals with AIDS. (Aerosolized pentamidine,

an inhaled drug sometimes prescribed for pneumonia in AIDS patients, is widely used in this

population and is often also supplied by HDIT

providers.)

The Safety of HDIT

Considerations and Risks Infusion Therapy

All medical therapies carry some degree of risk.

Although drug infusion therapy has been a routine

inpatient procedure for many years and is generally

safe, adverse outcomes do occur, even in closely

monitored hospital settings. Each year almost 1.5

million patients of the 17 to 24 million that receive

IV therapy (mostly as inpatients) experience some

form of complication (345). Of these, about 3,000

die from complications of IV therapy (93).

Complications of infusion therapy fall into two

general categories: local and systemic (i.e., not

confined to a specific area of the body). Table 2-3

summarizes some of these potential complications,

the more common of which are described briefly

below. Although the complications described are

applicable to most types of infusion therapy, IV

therapy is the most common, and complications are

described in this context.

Local Complications

Phlebitis--Perhaps the most frequently encountered complication of any infusion therapy is phlebitis-inflammation at the site of the catheter insertion. (If there is also a blood clot at the IV site, the

condition is termed thrombophlebitis.) Depending

on the situation, this complication has been estimated to occur in 3.5 to 70 percent of all patients

receiving IV medication (61). Phlebitis can result

Table 2-3-Potential Complications of

Intravenous Therapy

Local complications

Phlebitis, thrombosis, thrombophlebitis

(inflammation and/or blood clot of a vessel)

Suppurative thrombophlebitis

(infected blood clot in a blood vessel)

Infiltration and extravasation

(seepage of infusate into surrounding tissue)

Cellulitis

(infection of the soft tissue)

Nerve, tendon, or ligament damage

Hematoma

(accumulation of blood within tissues)

Collapsed blood vessel

Venous spasm

Pain

Systemic complications

Septicemia, bacteremia, pyrogenic reation

(diffuse, blood-bome infection)

Embolism

(obstructIon of a Hood vessel)

Pneumothorax, hemothorax, hydrothorax

(air, blood, or fluid in the chest cavity)

Hypersensitivity/allergic reaction

SOURCE: Adapted from C.W. Delaney and M.L. Lauer, Intravenous

T3erqy; A Guids ?0 Qua/ify Care (Philadelphia, PA: J.B.

Uppincott Co., 1988).

from chemical (e.g., a highly irritating drug), mechanical (e.g., catheter-caused irritation), and biologic causes (e.g., contamination of the drug container). Careful attention to proper procedure can

reduce the rate of infection (see ch. 3). If left

untreated, infectious thrombophlebitis has the potential to cause more severe complications, including septicemia and death (see below).

Infiltration-Venous catheters that are improperly placed or have dislodged from the vein deliver

the infused solution into the tissue around the vein

rather than into the vein itself. This complication can

be extremely painfull, especially if the infusate (the

infused solution) consists of some kind of irritant. In

the case of ant.ineoplastic therapy for cancer patients,

an IV infusion that has infiltrated can be particularly

devastating. Antineoplastic drugs are, by nature,

very caustic, and infiltration of these agents into soft

tissue can cause widespread tissue destruction,

necessitating tissue debridement, skin grafting, and

other surgical procedures (398).

c The need for blood transfusions maybe reduced somewhat with the introduction on the market of the drug erythropoei~ recently approved by

the FDA to treat anemia in AIDS patients.

7 Septicemia is the presence of disease-causing bacteria in the bloodstream.
Chapter 2—The Safety and Effectiveness of Home Drug Infusion Therapy .33

Systemic Complications

Sepsis--One of the causes of phlebitis is infection

at the site of IV catheter insertion. Untreated

infectious thrombophlebitis can lead to severe consequences. If the patient’s immune system is unable

to destroy the invading organism, it can continue to

multiply and infect virtually all recesses of the body.

This condition, known as sepsis, can be fatal; each

year 20,000 to 30,000 patients die from catheterrelated sepsis (79). Careful attention to early signs of

catheter infection or even early sepsis can mitigate

the impact of this devastating condition.

Embolism—Particulate matter that is introduced

into the venous system by an IV catheter (the

embolus) becomes lodged in small vessels and stops

circulation (embolism). If the tissue supplied by that

blood vessel does not have adequate collateral

circulation, it dies. The consequence of this complication depends on where the embolus lodges.

Because of the dynamics of circulation, an embolus

from a venous catheter usually ends up in the lung,

causing a variable amount of destruction-and even

death-depending on the size of the embolus.

Embolic material maybe of several sources. The

most frequent form of catheter-associated embolism

is a blood clot that has formed at the site of

thrombophlebitis, then broken loose and lodged

elsewhere in the bloodstream (93). Improperly

inserted catheters can also break off or dislodge and

form a source of embolic material. Air, if mistakenly

introduced into the catheter, can also serve as an

embolic source (93).

Allergic Reaction—Almost all IV drugs have the

capacity to produce an allergic reaction. The manifestation of that reaction, however, can range from a

mild skin eruption to circulatory shock and death.

Unless there is a prior history of drug allergy in the

particular patient, allergic reactions are not predictable. Safe administration of parenteral drugs thus

requires prompt identification and early treatment of

reactions.

Drug allergies are relatively common. For example, about 2 percent of the population is allergic to

penicillin (387), and an estimated 400 to 800 deaths

in this country are attributable to this cause (320).

Elderly patients (who may have more exposure to a

drug and, therefore, more chance to develop an

allergy to it), patients with a history of other

allergies, patients with a history of a prior drug

reaction, and patients with certain underlying conditions all represent groups at risk for drug allergy.

Certain biological and chemical characteristics of

the drug also affect the frequency with which it

causes allergic reactions in those exposed to it.

Other Drug Reactions-Besides allergic reactions, drugs can cause a variety of other problems.

Some of these are predictable occurrences and are

frequent, recognized side effects of the drugs that are

used. Other complications are less predictable and

are termed idiosyncratic. For example, patients

treated with the antibiotic chloramphenicol have a

small but distinct chance of developing complete

destruction of their bone marrow. Only about 1 out

of 30,000 patients will develop this complication,

but the mortality rate in those patients who do

develop it is quite high (129). The consequences of

many idiosyncratic drug reactions can be minimized

if the reaction is identified early. Thus, prevention of

serious complications from many drug reactions

relies on prompt recognition and early intervention.

Factors Affecting Complication

Rate and Severity

The frequency and severity of complications in

patients receiving infusion therapy depends heavily

on the clinical characteristics of the patient, the

therapy given, and the clinical competence of the

provider.

Of these factors, the patient’s underlying condition is probably the most fundamentally important.

Comorbid conditions that predispose individuals to

complications significant.ly affect the outcome of

patients treated with infusion therapy (131). An

AIDS patient treated for bacterial pneumonia, for

example, would be expected to be at a far greater risk

for complications than would another pneumonia

patient without the underlying problem of AIDS.

The specific diagnosis for which any particular

drug infusion therapy is employed also influences its

safety. For example, a patient treated for cellulitis

with IV antibiotics can tolerate the complications

associated with that therapy much better than a

patient with meningitis treated with the same

therapy; the patient with meningitis has an inherently less stable condition and is more at risk for

poor outcome should any drug side effect occur. For

this as well as many other reasons, the cellulitis

patient might be treated at home, but the meningitis

patient would remain in the hospital for therapy.
34. Home Drug Infusion Therapy Under Medicare

Some categories of therapeutics are inherently

more risky than others. Antineoplastic drugs, for

instance, are usually more toxic than are antiinfectives. Within each category, however, is a

hierarchy of toxicities; some anti-infectives have the

potential for more serious side effects than some

antineoplastics. Amphotericin B, a drug used to treat

severe fungal infections, for example, causes “potentially dangerous reactions in most patients” (11)

and can be fatal if inadequately administered and

monitored. In contrast, the side effects of leupride, a

hormone used in the management of prostatic

cancer, include bone pain, hot flashes, nausea, and

impotence (11). Although these side effects are

unquestionably unpleasant, they are far less potentially lethal than those seen with amphotericin B.

Similarly, the choice of vascular access device8

can affect the types and rates of complications that

arise. Central venous catheters, which lie near major

vessels, nerves, and organs, have the potential to

cause more severe consequences if infiltrated or

inserted improperly than a standard peripheral IV

catheter, and the long-term implantation and direct

vascular access of central catheters makes them

more susceptible to potentially dangerous infections

(see ch. 3).

The provider also plays a major factor in the

outcome of patients treated with infusion therapy.

Adherence to published guidelines for the proper

care of infusions and infusion devices reduces the

frequency and severity of complications (311). Strict

aseptic technique, regular changing of the site where

a peripheral catheter is inserted, and careful attention

to any early sign or symptom of an infusion-related

complication is required of any home care provider

(312). (The role of quality review to ensure the

competency of providers is explored in chapter 5.)

Relative Risks: Home v. Hospital Drug

Infusion Therapy

None of the complications of infusion therapy

described above is setting-specific. The consequence of these problems, however, may differ

depending on whether the therapy is given in the

home or in a medical setting.

The degree of monitoring that occurs in the

standard inpatient setting is usually greater than can

occur in the home, because of the use of electronic

monitoring in many patients and because nurses and

physicians are on site. One tradeoff to home

administration of infusion therapy, therefore, is a

potentially higher frequency of unrecognized and/or

untreated complications from the drugs themselves.

Infection at the catheter site, for example, can

potentially be recognized at an earlier stage by

trained personnel in the hospital and be treated

effectively by IV site rotation. The same catheter site

infection may not be recognized as early at home and

a more extensive infection may ensue.

Alternatively, there are certain complications that

can actually be worse in the hospital setting than if

they were encountered in the outpatient (or home)

setting. Catheter site infections that occur in the

outpatient setting, for example, are usually caused

by organisms that are fairly susceptible to most

antibiotics. Those acquired in the hospital, on the

other hand, are usually caused by more aggressive,

less sensitive organisms which can be more difficult

to treat. In one survey of a hospital-based home

infusion therapy program, nosocomial (hospitalacquired) infections were seen in approximately 14

percent of hospitalized patients compared with

almost no infections in the patient group being

treated as outpatients (15). Some of this difference is

undoubtedly due to the presence of more stable

patients in the outpatient group, but some is probably also due to the reduced exposure of outpatients

to potentially significant nosocomial infections.

Any patient who is starting a new drug is at risk

of experiencing an unpredictable allergic reaction or

other drug-related complications. Thus, even when

home infusion is otherwise feasible and safe, the first

dose of any infused drug is usually administered

under medical supervision, in the hospital, physician’s office, or outpatient clinic, where personnel

have access to needed resources should a dangerous

reaction occur (15,131). Similarly, when the drug is

changed during the course of home therapy (e.g.,

when a more sensitive antibiotic is substituted to

achieve better therapeutic results), many providers

believe the patient should return to a supervised

setting for the initial dose (15).

Whether the elderly are, on average, at greater risk

of infusion-related complications than younger patients is not entirely clear. One the one hand, elderly

individuals are more likely to have other disabilities

8 See chapter 3 for a discussion of venous access devices.
Chapter 2—The Safety and Effectiveness of Home Drug Infusion Therapy ● 35

that may affect their health state, and they may be

more likely to develop allergic reactions to a drug

due to a greater chance of past exposure. On the other

hand, there is no clear evidence that well-screened

elderly patients on HDIT are at higher risk of

complications. The single study in the literature on

the topic found no difference in the therapeutic

outcome of elderly and nonelderly patients treated

with home IV antibiotic therapy when similar

clinical and social inclusion criteria were used for

both groups (65). It may be that fewer elderly than

nonelderly patients would meet strict screening

criteria, but that once those criteria are met the risks

of HDIT in the two groups are comparable.

The Effectiveness and Use of HDIT

Reports on home use of a multitude of drug

infusion therapies can be found in the literature. By

far, the most common category of drugs is antibiotics and other anti-infectives. Based on estimates by

market analysts and other sources, it appears that

about two-thirds of current HDIT involve antiinfective drugs (34,193) (table 2-4). Approximately

another 15 percent of HDIT drugs are antineoplastics or pain medications. The diverse remaining

group of drugs makes up somewhere between 10 and

20 percent of HDIT at present. Although small and

encompassing many unrelated drugs, this “other”

group appears to be have grown rapidly (364).

Estimates based on drug orders and drug revenues

may not reflect exactly the actual distribution of

patients on different therapies. One investigator, for

example, reports that antibiotics accounted for about

two-thirds of drug orders but only about one-half of

patients in his study (193a). A recent survey of the

records of 35,000 patients served primarily by large

infusion specialty companies likewise found that

just over one-half (52 percent) of drug infusion

patients were on antibiotics, another 21 percent were

receiving either antineoplastics or pain medications,

and over 5 percent were receiving more than one

type of drug infusion therapy (256).

Antibiotics

Antibiotic and other anti-infective drugs constitute the bulk of HDIT for good reason. Their safety

and efficacy when provided in nonhospital settings

has been demonstrated in a number of studies

(106,148,267,325). In virtually all of these studies,

home patients achieved cure rates as good as or

better than those attained in the inpatient setting.

Table 2-4-The Home Drug Infusion Market, 1989

Total revenues

Millions Percent of

Therapy of dollars market

Antibiotic therapy . . . . . . . . . . 600.0 69.6

Pain management . . . . . . . . . 91.1 10.6

Antineoplastic therapy. . . . . . 125.8 5.1

Other therapies . . . . . . . . . . . 484.2 14.6

Total . . . . . . . . . . . . . . . . . . . . 1.301.1 100.0’

Wumbers do not add to exactly 100 due to rounding.

SOURCE: Adapted from Biomedical Business International, Santa Ana,

CA, “Home Infusion Therapy Markets,” 1989.

Table 2-5-Percentage of Intravenous Antibiotics Used

in Home Treatment in Two States, 1989

Drug North Carolina Florida

Amphotericin . . . . . . . . . . . . . 6.5

Cefazolin . . . . . . . . . . . . . . . . 3.2

Cefotetan . . . . . . . . . . . . . . . . 8.1

Ceftazidime . . . . . . . . . . . . . . 8.1

Ceftriaxone. . . . . . . . . . . . . . . 25.8

Gentamicin . . . . . . . . . . . . . . . 8.1

Tobramycin . . . . . . . . . . . . . . 3.2

Vancomycin . . . . . . . . . . . . . . 12.9

All other drugs . . . . . . . . . . . . 22.8

—

16.7

—

2.7

11.1

6.9

8.3

15.3

35.9

SOURCE: Adapted from C. Kozma and J. Glaze, “Impact of Home LV.

Benefits on Beneficiary Utilization of Services,” interim paper

prepared for Health Care Financing Administration, Baltimore,

MD, Cooperative Agreement No. 17-C-9957/4-01, April 1990.

Home antibiotic therapy is reported to be effective in

over 90 percent of cases (148,325).

The frequency with which a particular compound

or class of compounds finds use in HDIT is related

to the severity of associated complications. More

aggressive and potentially complicated drugs are

used less often.

Cefazolin and ceftriaxone, two members of a class

of antibiotics known as cephalosporins, account for

about half of all home IV antibiotics (table 2-5).

Cephalosporins are relatively new antibiotics that

share a number of characteristics that make them

attractive for use in the home setting. In general, they

are comparatively safe and act on a fairly broad

spectrum of disease-causing organisms. Additionally, they require little monitoring and fairly infrequent administration. Ceftriaxone, for example, is

usually administered only once or twice a day (11).

Its infrequent administration makes it much more

convenient for home use than penicillin, which has

a similar spectrum of action but must be given much

more frequently to be effective.

Unfortunately, ceftriaxone may not be particularly effective against Staphylococcus aureus, a
36. Home Drug Infusion Therapy Under Medicare

common organism that is frequently encountered in

the kinds of infections seen in the home care setting

(148,317). Other antibiotics, such as cefazolin and

methicillin, appear to be more effective and can be

used in the home to treat infections from this

organism, although they require a more frequent

dosing schedule (317).9

Another consideration in choosing a particular

antibiotic for use in the home is the stability of the

compound once the drug is mixed. Several antibiotics that are used extensively in hospitals, such as

ampicillin and trimethoprim-sulfamethoxizole, have

a very short period of stability when prepared for an

IV infusion. Thus, they are rarely used in the home,

where drugs and supplies are often delivered no

more than once every week or two to minimize costs

(3,317,364).

Complications

The incidence of complications arising from

home IV antibiotic use is small. Although no drug is

entirely safe, antibiotics, in general, are relatively

safe and without significant adverse side effects

when compared with other classes of drugs. Specific

complication rates documented in published studies

and in data provided to the Office of Technology

Assessment (OTA) range from 6 to 20 percent

(106,148,250,267). Almost none of the complications encountered were unique to the home setting

but were inherent to IV therapy per se. A detailed

record review performed by one HDIT provider

found an IV-related complication rate of 10 percent

(250) (table 2-6).

One complication unique to the home setting is an

“antabuse” type of reaction10 seen with certain

cephalosporins. When a patient treated with these

drugs also consumes alcoholic beverages, the combination can produce symptoms that include severe

flushing, nausea and vomiting, chest pain, marked

uneasiness, weakness, and confusion. Hospitalized

patients do not usually consume alcohol and are not

prone to developing this side effect. Patients at

home, on the other hand, have free access to alcohol

and thus have the potential for developing this drug

interaction (106). The severity of the reaction is

Table 2-6-Complications of Infusion Therapy

Reported by One Home Infusion Provider

Complications presumed related to infusion therapy

Catheter infection

HIVa infection complication

(resulting in immunosuppression)

Diarrhea/dehydration

Respiratory distress

Increased wound infection symptoms

Fever of unknown origin

Central venous catheter replacement

Sepsis

Exacerbation of condition

(possibly drug related)

Bacteremia

Proportion of all home infusion patients experiencing

complication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10.1%

aHIV - human immunodefieieney virus.

SOURCE: H. O’Keiff, Barnes Home Health Ageney, Inc., St. Louis, MO,

letter to the Office of Technology Assessment, Feb. 28, 1991.

roughly proportional to the amount of alcohol

ingested (11).

Antineoplastic Therapy

The goal of antineoplastic therapy is to selectively

inhibit or destroy the rapidly dividing cells of a

malignant tumor, while leaving the patient’s normal

cells intact. Different classes of antineoplastic drugs

accomplish this goal in a variety of ways, with no

single therapy universally applicable to all forms of

cancer. Often, multiple antineoplastic agents are

combined in a regimen to take advantage of the

different modes of action while minimizing the

varied toxicities.

Several trials and pilot studies have demonstrated

the efficacy and safety of home IV antineoplastic

therapy (116,201,263,294). In practice, a wide

variety of agents are employed. One home infusion

provider, for example, supplied seven different

antineoplastics and related services to home patients

in 1989 (250).11

Antineoplastic agents are frequently accompanied by serious side effects (table 2-7). The drugs

find use despite these side effects because the

underlying condition being treated has such a grim

prognosis. Nonetheless, antineoplastic therapy presents a particular concern for safety in the home,

g There is not complete agreement on the relative effectiveness of these drugs; some physicians maintain that ceftriaxone maybe nearly as effective

as eefazolin against this organism (340a).

10 ~s ~emtion is identi~ t. tit seen in pati~ts ~g the ~g ~~~~ (~~buse), a ~g u~d w m adjwct to &w@ dlKMlk alcoholism

(129), and has, therefore, been termed the ‘%ntabuse reaction.”

11 me ~gs Wae fitom~one, v~bl~~e, metho~mte, flu~ro~acfl, doxorubic~ ~clophosp~de, ~d vincristine.
Chapter 2—The Safety and Effectiveness of Home Drug Infusion Therapy .37

Table 2-7—Toxicity of Antineoplastic Drugs

Major acute toxicity Major delayed toxicity

Diarrhea/ Hypersensitivity Bone

Chills/ nausea/ Local irritant/ reactions and

Drug

marrow

fever vomiting local pain anaphylaxis Othera depression Othera

Asparaginase . . . . . . . . . . . . . . . . . . X

Bleomycin . . . . . . . . . . . . . . . . . . . . . . X

Carmustine . . . . . . . . . . . . . . . . . . . . .

Cisplatin. . . . . . . . . . . . . . . . . . . . . . . X

Cyolosphosphamide . . . . . . . . . . . . .

Cytarabine, cytosine arabinoside . . . X

Dacarbazine . . . . . . . . . . . . . . . . . . .

Dactinomycin . . . . . . . . . . . . . . . . . . .

Daunorubicin . . . . . . . . . . . . . . . . . . .

Doxorubicin , . . . . . . . . . . . . . . . . . . .

Floxuridine (FUDR) . . . . . . . . . . . . . .

Fluorouracil (5-FU) . . . . . . . . . . . . . .

Mechlorethamine . . . . . . . . . . . . . . .

Methotrexate . . . . . . . . . . . . . . . . . . .

Mitomycin . . . . . . . . . . . . . . . . . . . . . .

Plicamycin . . . . . . . . . . . . . . . . . . . . .

Streptozocin/streptozotocin . . . . . . .

Thioquanine . . . . . . . . . . . . . . . . . . .

Thiotepa . . . . . . . . . . . . . . . . . . . . . . .

Vinblastine . . . . . . . . . . . . . . . . . . . . .

Vincristine . . . . . . . . . . . . . . . . . . . . . .

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x x

x

x x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

a~tother” amte toxi~ties in~~e r~ urine, elWtrm~iWram &anges, and orthostatic hypotension. “Other” delayed toxicities include such side eff~~ as

hair loss, liver and kidney damage, oral ulcers, stomatitis, neurological defects, and thrombocytopenia.

SOURCE: Based on T.M. Speight (cd.), Avery’s Drug Treatment (Auckland, New Zealand: ADIS Press Ltd., 1987).

where both the ability to deal with the side effects

and the system to dispose of the toxic drugs

themselves are less available.

Many antineoplastic agents are vesicants and can

cause severe irritation to the vein. When administered through a peripheral catheter, the incidence of

thrombophlebitis is much higher than for most

antibiotics and other nonvesicant drugs. To minimize the damage done to the vein, antineoplastic

agents are frequently administered directly into a

large, central vein to dilute the drug and diminish its

toxicity. Table 2-8 lists some examples of IV

antineoplastic agents and the requirements for administration.

Depending on the particular kind and location of

the cancer, some antineoplastic drugs can be given

directly into the artery that supplies it with blood. By

delivering a more concentrated dose of a drug to the

tumor, the potential for side effects can be minimized. Thus, intraarterially delivered antineoplastics produce fewer systemic side effects than they

would if given intravenously. The tradeoff, in this

instance, is the potential problems associated with

intraarterial drug administration.

The advent of continuous infusion therapy has

expanded the number and kinds of antineoplastic

agents that may be delivered in the home setting

(201,297). To achieve effective concentrations when

given intermittently, a drug may need to be given at

such high dosage that it causes serious side effects.

As a continuous infusion, however, the concentration required for efficacy is often not as great and

some adverse consequences can be avoided. Thus,

the toxic effects of certain antineoplastic agents can

be reduced by utilizing a longer exposure to a lower

dose without losing any of the clinical efficacy.

The appropriateness of home antineoplastic therapy for a particular patient depends heavily on the

underlying condition of that patient. Cancer patients

are often weakened or incapacitated by the devastating effects of the disease and the therapies used to

treat it. Unless these patients have sufficient in-home

help in the form of a family member or other

caregiver, home IV antineoplastic therapy is often

not possible. Patients who are unwilling to learn the

techniques, have an inadequate support system, or

are physically unable to master the skills required

thus represent poor risks for home IV therapy (35).

Even if help and support are available, the tremendous demands frequently presented by cancer pa-
38. Home Drug Infusion Therapy Under Medicare

Table 2-8-Examples of Special Considerations in Administering Intravenous (IV) Antineoplastics

Drug Special considerations

Asparaginase . . . . . . . . . . Life-threatening anaphylaxis can occur. Skin testing and desensitization recommended before administration.

During administration, a physician/life support equipment and epinephrine, antihistamine, and

corticosteroids should be available; monitor blood pressure.

Bleomycin sulfate. . . . . . . Increased incidence of anaphyiaxis in lymphoma patients; give test dose. Give acetaminophen and

antihistamine 30 min. before chemotherapy to prevent fever and chills.

Carmustine . . . . . . . . . . . . Pain, burning at IV site and facial flushing may occur secondary to alcohol diluent; if this occurs decrease rate,

increase volume in which drug is diluted.

Cisplatin . . . . . . . . . . . . . . Before and during treatment, hydration and raised urinary output are essential to prevent nephotoxicity. Shorter

infusion time may be associated with increased risk of kidney toxicity. Avoid the use of needles containing

aluminum, as it reacts with Platinol to create a black precipitate and loss of potency. Anaphyiactic reactions

may be controlled by epinephrine and corticosteroids.

Cyciophosphamide . . . . . To prevent hemorrhagic cystitis, patient should drink 3 to 4 liters of fluid per day and void frequently. Dizziness,

rhinorrhea, sneezing and diaphoresis have been reported with doses of greater than 500 mg when given

quickly.

Etoposide . . . . . . . . . . . . . Hypotension and wheezing may occur if given too rapidly (in less than 30 min.). Stop infusion if wheezing

occurs; antihistamines may be helpfull.

SOURCE: Based on C.B. Hughes, “Giving Cancer Drugs IV: Some Guidelines,” American Journal of Nursing 86:34-38, 1986.

tients can easily overwhelm the support system,

requiring inpatient hospitalization.

Analgesics

Pain is a dominant feature of many disease

conditions. Up to 70 percent of cancer patients suffer

severe pain (401). Pain can usually be managed

effectively with oral medication, but certain circumstances preclude this form of therapy. Patients with

oral, esophageal, or other cancers which prevent

normal swallowing, patients with breakthrough pain

despite high doses of oral narcotics, and patients

who suffer side effects related to the high doses of

oral narcotics often required to control pain are

candidates for parenteral analgesics (185).

Parenteral narcotic analgesics include meperidine, morphine, and hydromorphone. Their use in

parenteral pain management varies widely; in one

survey, the average duration of pain management

therapy for different drugs ranged from 2 to 240 days

(193). This variation probably reflects the relatively

few patients on this therapy represented in the

survey and the heterogeneous conditions for which

pain control is used. IV narcotic pain relief has even

been reported in a 2-year-old child being treated at

home for advanced cancer of the brain (286).

While IV narcotic administration for pain control

has been available for many years, the concept of

home administration is fairly new. Two recent

developments have been particularly important to

enabling home parenteral pain control in many

patients. First has been the development of infusion

pumps with a patient-controlled analgesia feature.

This feature allows patients to optimize pain relief

but minimize drug side effects, by combining a

constant preprogrammed baseline level of relief with

the option to self-administer larger boluses of

medicine when pain is particularly severe (265).

Second, subcutaneous administration of narcotics

has become a more accepted alternative that avoids

some of the potential complications of IV therapy. In

fact, subcutaneous pain management is considered

by some to be superior to IV administration because

of its equivalent effectiveness in many patients and

its technical advantages (227).

Additionally, intrathecal and epidural administration of narcotics have been used for several years

and are being increasingly considered as options for

the home. A number of reports of parenteral pain

management through one of these routes have been

published (316,326,327), and HDIT providers report

having provided them (250). However, intraspinal

administration of narcotics is associated with complications including urinary retention, nausea and

vomiting, and respiratory depression (202). Narcoticinduced respiratory depression, which is especially

dangerous, can be detected by using an apnea

monitor and can be counteracted by infusing an

antagonistic agent (e.g., for morphine, Narcan is the

antagonist) (202). Because respiratory complications may not present for up to 22 hours after

epidural narcotics administration (309), these patients require extended monitoring and therefore can

pose additional challenges for home care.
Chapter 2—The Safety and effectiveness of Home Drug Infusion Therapy .39

One concern unique to home parenteral narcotics

administration is the potential for abuse of the drugs

on the part of patients or family caregivers.12

Providers of this therapy report such measures as

hospitalizing patients with a history of IV drug

abuse, rather than treating them at home, to minimize the opportunity for abuse; and discontinuing

home therapy when it became apparent that a family

member was diverting drugs intended for the patient

(364). Special measures, such as using infusion

pumps that enable the drug cassette to be locked and

replaced only by a visiting nurse, may be required

for home parenteral narcotic administration to be a

safe option.

Other Therapies13

Dobutamine

Patients with congestive heart failure (CHF)

suffer from an inability of the heart to pump a

sufficient amount of blood to the vital organs.

Dobutamine, which acts by increasing the force of

contraction of the heart, has been used conventionally as a temporary measure in patients with

underlying CHF whose heart needs assistance to

deal with additional stress (e.g., an acute viral

infection) (198). Dobutamine can only be administered intravenously, and until recently it was only

administered in the hospital. In 1977, however,

researchers discovered that 72-hour intermittent

infusions of dobutamine improved cardiac function

for prolonged periods (196). Subsequent studies

confirmed these findings and furthered the idea that

periodic outpatient admini stration of IV dobutamine

may add to the treatment options for patients with

CHF (205,348,349).

While the hemodynamic benefits of outpatient

dobutamine are encouraging, the unexpected finding

of increased mortality in these patients is not. One

controlled study of the treatment found that despite

significant improvement in symptoms during the

study, 15 of 37 dobutamine patients (40 percent)

died, while only 5 of 23 placebo-treated patients (22

percent) did so (94). The increased mortality was

subsequently attributed to cardiac arrhythmias (irregular heartbeats). A recent study of an oral drug

related to dobutamine likewise found that, despite

the drug’s predicted benefits, long-term therapy

actually increased morbidity and mortality in patients with severe CHF (251).

Some researchers believe that many of the patients at risk of death during dobutamine treatment

could be identified by means of pretreatment cardiac

monitoring (322). The poor record of this and related

drugs in existing studies, however, suggests that

they do not merit long-term use in the home unless

effectiveness in specific patient groups can be

demonstrated.

One final argument favoring the use of IV

dobutamine is that it may enable a patient with CHF

who is a heart transplant candidate to survive until

a suitable organ becomes available. Dobutamine is

prescribed by some physicians for this purpose

(73,365). Given the current evidence described

above, this strategy may not really enhance a given

individual’s chance of receiving a transplant. Even

if it does, it cannot increase the total number of

people who ultimately can receive a new heart,

because the number of heart transplants is limited by

the supply of donor organs. The number of persons

on the waiting list for heart transplants exceeds the

number of transplants by about 30 percent (385a).

Immune Globulin

Human immune globulin was first used to treat

patients whose bodies were naturally deficient in

this substance in 1952 (52). Early administration

consisted of periodic intramuscular injections (54).

Intravenous preparations became available in the

United States in 1981, and they are generally

preferred for long-term therapy because they are less

painful to receive and enable much larger doses to be

given (54).

The clearest and most accepted indications for

immune globulin therapy are for treating patients

with severely impaired antibody-producing capacity

(54). These patients may have any of a number of

rare primary immunodeficiency diseases, such as

severe combined immunodeficiency. Many of these

conditions are chronic, and some individuals with

12 6CF~y~m~vem!! me d~m~ ~ this ~pfi ~ cme@rms who are close friends or relatives of the patient and who gene~ly receive no f~cial

compensation for their services.

13 ~ addition t. tie therwies de~fibed here, the list of ~gs some~es infused at home includes tocolytic drugs to prevent preterm labor (e.g.,

terbutaline and ritodrine); anticoagulant drugs (e.g., heparin); certain autiulcer drugs; and chelating drugs to rid the body of toxic levels of metals (e.g.,

deferoxarnine).
40. Home Drug Infusion Therapy Under Medicare

them conditions require IV immune globulin therapy for life.

IV immune globulin is also sometimes used to

bolster the immune systems of persons whose

immunodeficiencies are secondary to another condition (e.g., those who have received immunosuppressive drugs in connection with their cancer treatment)

(54,235). Recently, immune globulin has been

shown to be effective in reducing the incidence of

infections in children with AIDS (234) and in

patients with chronic lymphocytic leukemia (77).

The therapy is also gaining acceptance in treating

other disorders that involve the immune system in

some way, such as immune thrombocytopenic

purpura, Kawasaki syndrome, and steroid-dependent asthma (323). Some have suggested that it may

be successful in treating intractable seizure disorders, but it has not been tested for this use in a

controlled study (235).

As IV immune globulin therapy has become used

to treat a wide variety of diseases, questions have

been raised about its cost. The charge for a single

infusion of immune globulin has been reported

anecdotally to be $125 to $250, making the annual

charge for therapy for a typical adult requiring

regular infusions over $25,000 for the drug alone

(54). In some hospitals, immune globulin has

become one of the top four drug expenditures (323).

Some researchers have calculated the cost of prophylactic IV immune globulin for chronic lymphocytic leukemia to be $6 million for every qualityadjusted year of life gained (394).

The high cost of IV immune globulin therapy in

the hospital, the fact that many patients are on

therapy indefinitely, and the fact that many of these

patients are children make home therapy attractive.

A number of studies have shown that IV immune

globulin therapy can indeed be provided safely in the

home, with an effectiveness comparable to hospital

therapy (17,190,191,247). Home use, however, will

not reduce the costs of the drug itself.

Immune globulin therapy is not entirely free from

the possibility of adverse events associated with the

infusion of this substance. Mild reactions include

nausea, fatigue, and headache; more serious reactions include severe chest pain, abnormal heartbeat,

and mental confusion (122,235). These reactions can

occur during or within minutes of treatment and may

require immediate countermeasures (122). One recent study found that, of three methods of administering home immune globulin (intramuscular injection, IV infusion, or rapid subcutaneous infusion),

rapid subcutaneous infusion resulted in the fewest

adverse events while retaining its effectiveness

(122). The results of this study, which was carried

out in Sweden, suggest that more examination of

subcutaneous administration in U.S. patients on

long-term immune globulin therapy is warranted.

Blood Transfusions

The prototypical home transfusion patient is one

who is anemic because of a chronic, debilitating

condition, such as cancer or AIDS, and for whom

transportation to a hospital or outpatient clinic

would cause great difficulty (3,7,223,261). Anemia,

by definition, is a reduction in the volume of red

blood cells, and anemic patients usually have

insufficient oxygen-carrying capacity in the blood

(262). In addition to cancer- and AIDS-related

anemias, certain other anemias (e.g., sickle-cell

anemia) also may require transfusions of red blood

cells14 and might occasionally be treated in the

home.

Individuals with thrombocytopenia (platelet deficiency), which impairs blood clotting at the site

where a blood vessel is injured, may be candidates

for home platelet transfusions. Thrombocytopenia

can be caused by many different mechanisms, such

as a bacterial infection or secondary to certain types

of liver disease and bone marrow disorders (184).

Transfusion therapy poses certain risks unique to

this form of infusion. It requires strict patient

selection criteria and rigid transfusion procedures

due to the potential severity of the body’s reaction to

foreign blood components.

The most serious reactions result from an incompatibility between antigens of the transfused blood

component and the patient’s antibodies. The consequence of this incompatibility is hemolysis, the vast

destruction of red blood cells (7,184). Hemolysis can

be fatal. Clinical symptoms include fever, chills,

back pain, and possible shock. Proper followup and

good patient records are imperative to ensure that

donor and recipient blood are appropriately

14 r-r~m~ blind &-iom “My ~wayS involve tisio~ of o~y c-ex~ct~ blood components. patients in ned Of whole blood

transfusions usually are those in need of urgent and intensive care (e.g., trauma patients) who are therefore unsuitable for home therapy.
Chapter 2—The Safety and effectiveness of Home Drug Infusion Therapy ● 41

matched; all home acute hemolytic reactions are due

to clerical errors.

Febrile, non-hemolytic reactions are usually due

to antibodies that cause clumping of the white blood

cells that poison or destroy cells. Such a reaction

usually occurs within the frost 1 or 2 hours of the

transfusion. Characterized by chills and fever, nonhemolytic reactions usually can be treated successfully with aspirin or acetaminophen. However, a

non-hemolytic reaction may signal a hemolytic

reaction; symptoms must be considered potentially

life-threatening until a hemolytic reaction can be

ruled out (7,184).

Emerging Therapies

The broad acceptance of home drug infusion

makes it likely that new and future drugs that must

be given parenterally may find application in the

home. Following are some examples of drugs that

have recently begun to be used in this setting, or

which might be provided in this setting in the future.

Granulocyte colony stimulating factor(G-CSF)

—A bioengineered version of a natural substance that regulates the growth and development of certain white blood cells, G-CSF has

recently been approved by the FDA for use in

cancer patients with low white blood cells

counts and fever (15 1). Because it is a protein

and subject to degradation by digestive enzymes, G-CSF must be administered parenterally (either IV or subcutaneously). It is

administered as a daily injection for up to 2

weeks in conjunction with the patient’s antineoplastic therapy cycle (14a). Because many

patients are now receiving their antineoplastic

therapy at home, G-CSF is also sometimes

administered concomitantly at home (176).

Granulocyte microphage-colony stimulating

factor (GM-CSF)-Closely related to G-CSF,

GM-CSF plays a similar biological role in

acting to raise the white blood cell count. It also

has been recently approved by the FDA for use

in patients with Hodgkin’s disease, rlOrlHodgkin>s lymphoma, and acute lymphoblastic

leukemia who undergo bone marrow transplant

(151). GM-CSF must be administered parentedally and may be used in the home by posttransplant patients. In addition, it has possible

uses in cancer and AIDS patients who are at risk

of infections (302).

Post-transplant immunosuppressive drugs—

Transplant recipients must usually take drugs

that suppress their immune systems, preventing

the body from rejecting the grafted organ. Most

drugs currently used for long-term posttransplant immunosuppression are oral drugs

such as cyclosporine. One FDA-approved drug,

however-Orthoclone OKT-3—is an IV drug.

Although its prophylactic use thus far has taken

place while the patient is still hospitalized after

the transplant (91), this and any future parenteral immunosuppressives might move home as

part of strategies to reduce the hospital stays of

transplant patients.

Interleukin-2-Still under development, interleukin-2 holds promise as a future treatment for

kidney cancer (282). The drug is not yet

approved by the FDA for use in the United

States, but its mode of administration (subcutaneous or IV) and the long-term nature of the

disease it treats make it a likely candidate for

home therapy if it should receive marketing

approval.

297-913 0 - 92 - 4
Chapter 3

HOME DRUG INFUSION THERAPY

EQUIPMENT AND SERVICES
Contents

Page

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Vascular Access Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Infusion Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Techniques and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Services and Staffing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Patient Screening and Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Ongoing HDIT Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Boxes

Box Page

3-A. Aseptic Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

3-B. Controversy Over Catheter Flushing Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

3-C. Staffing and Organization of Home Drug Infusion Therapy Services:

Two Contrasting Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

3-D. Patient Screening Criteria for One Home Intravenous (IV) Antibiotic

Therapy Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

3-E. Screening Criteria for Home Transfusion Therapy Patients . . . . . . . . . . . . . . . . . . . . . . 61

3-F. The Peripherally Inserted Central Catheter (PICC Line):

New Technology and Nursing Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

3-G. Home Blood Transfusion Services: Special Considerations . . . . . . . . . . . . . . . . . . . . . . 66

Tables

Table Page

3-1. Typical Supplies in a Delivery by One Company for Four Types of Home

Infi.mien Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

3-2. Recommended Routine Frequency of Selected Catheter Maintenance Procedures

Performed for Home Infusion Therapy Patients, by Type of Vascular Access

Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

3-3. Average Number of Nursing Visits Per Week for Home Infusion Therapy Patients,

by Selected Types of Vascular Access Device, Type of Therapy, and Functional

Status of Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Chapter 3

HOME DRUG INFUSION THERAPY EQUIPMENT AND SERVICES

Overview

Introduction

The home infusion therapy industry today is the

product of technological and medical advancements

achieved primarily during the past two decades, and

it is still evolving in response to continuing changes

in both these areas. Twenty years ago, home drug

infusion therapy (HDIT) without round-the-clock

nursing services would have been unthinkable.

Today, programmable infusion devices with built-in

safety mechanisms and safer, more comfortable

vascular access devices that can remain in place for

longer periods of time have enabled even bedridden

patients on complex therapeutic regimens to go

home.

Skills as well as equipment have advanced, and

many nurses and pharmacists now specialize in the

particular professional skills needed in HDIT (e.g.,

placement of a peripherally inserted central catheter,

drug regimen review). But not all HDIT techniques

demand such a high level of skill. Some (e.g., simple

wound care, drug administration) can be performed

by trained family caregiversl or by patients themselves. This chapter describes the variety of equipment and supplies used, the broad range of techniques and services involved, and the skilled and

nonskilled caregivers who provide HDIT in the

1990s.

●

Summary of Conclusions

The services and supplies needed for HDIT

vary significantly depending on the route of

administration, type of vascular access device, type of therapy, and rate of administration. For example, patients with peripheral

venous access require more ongoing skilled

nursing visits than patients with central venous

access. Patients with central access, however,

may need more intense training, more early

supervisory visits, and more phone support

until they become comfortable caring for their

catheter and administering their medication.

Patients who self-administer antibiotics three

times a day may require 20 times as many

●

●

intravenous (IV) administration supplies as

patients on continuous-infusion antineoplastic

therapy or pain management.

Although infusion devices have become increasingly sophisticated during the last decade, less expensive gravity drip systems are

still safe and appropriate for many therapies. Most antibiotic therapy and hydration

therapy can be delivered via gravity drip or

special disposable infusion devices, provided

patients (or their caregivers) are capable of

operating these devices. In-home gravity drip

systems often include special devices that

enhance safety and ease of operation by patients. Factors that may necessitate the use of

programmable infusion pumps include: cognitive or functional limitations of patients/

caregivers; extremely high or low dose volume;

therapies of long or otherwise inconvenient

duration; therapies requiring frequent administration; intraarterial infusions; and need for

carefully controlled rate of administration.

While some of the specific techniques used in

HDIT require the skills of specially trained

registered nurses (RNs), many tasks can be

performed by the patient or by a family member

who has been taught the proper techniques by

a qualified health professional. However, because Medicare beneficiaries are likely to be

sicker than other patients and they and their

spouses are more likely to have functional

limitations than younger patients, they are

more likely to need paid assistive services in

order to receive infusion therapy at home. If

the frequency and intensity of professional

services required by a home infusion patient are

great (e.g., a functionally disabled patient on a

4-dose per day antibiotic regimen who has no

informal caregiver available), a skilled nursing

facility (SNF) or other nonhospital institutional

setting that offers 24-hour supervision might be

a more reasonable alternative to hospitalization

than traditional home care.

● Within the nursing and pharmacy professions,

home infusion specialization is based primarily

1 k MS reW~ the tem “f@y ~e@er” refers to a mend or family member who assists an HDIT patient in self-care talcs on a nonptid bmk.

-45-
46. Home Drug infusion Therapy Under Medicare

on experience and has not yet achieved separate

recognition by professional organizations. Increasing availability of formal training in

infusion therapy techniques, however, is expanding the pool of qualified personnel. Although HDIT providers may occasionally have

difficulty recruiting qualified staff, available

evidence does not suggest a critical shortage of

qualified personnel.

The continual emergence of new HDIT technologies constantly broadens the types of

patients who can be treated at home and

changes the parameters of service delivery.

Each new device involves the use of new

techniques that must be learned by nurses,

pharmacists, and patients and caregivers. Some

recently developed technologies have reduced

the amount of skilled nursing intervention

required for patients at home and made it easier

for patients to self-administer complex drug

regimens.

Equipment

The two fundamental items of equipment used in

HDIT are the vascular access device2 (the path

through which a drug enters the bloodstream) and

the infusion device (the means of controlling the rate

of an infusion). Advances in vascular access and

infusion technology during the past two decades are

what have made HDIT possible, and the range of

patients who can receive therapy at home continues

to expand as new technologies emerge.

Vascular Access Devices

Twenty years ago, the most common mode of

parenteral administration was a steel needle inserted

into a vein in the hand or arm (peripheral vein).

Today, an increasingly broad array of vascular

access devices is available, ranging from peripheral

catheters (thin tubes inserted into a hand or forearm

vein) to totally implantable catheters that access the

centralmost vein of the body. The type of vascular

access device used in HDIT has implications for

both the amount of skilled nursing intervention

required and the nature and extent of certain

therapy-related risks for infusion patients.

The choice of a vascular access device depends on

the drug(s) to be infused, the route of administration,

the duration of therapy, and the physical condition of

the patient. Data from a recent survey of specialty

HDIT providers show that peripheral catheters are

used most frequently for antibiotic therapy, while

central catheters are more common for antineoplastic therapy, pain management, and patients on

multiple therapies (256). Most vascular access

devices can be used for more than one route of

administration. For example, tunneled catheters and

subcutaneous ports (see below) can be used for

intravenous, intraarterial, epidural, intrathecal, or

intraperitoneal administration; and peripheral catheters can be used for intravenous or intraarterial

therapy.

Peripheral Catheters

Many drugs (e.g., most antibiotics) can be infused

into a vein in the arm by way of a small catheter

inserted into the blood vessel. Peripheral catheters

are particularly appropriate in patients who require

relatively short-term therapy (e.g., 1 to 3 weeks) and

whose veins are healthy and can withstand repeated

punctures (145). Maintenance of peripheral routes of

administration requires frequent skilled nursing

intervention. Although able-bodied patients can

often manage the dressing changes (periodic replacement of bandages covering the catheter exit

site) with the assistance of family caregivers,3

catheter insertion requires professional skills.

Peripheral catheters must be changed frequently

to prevent swelling and irritation at the entry site that

can lead to infection. When this is done, the old

catheter is discarded and a new one inserted, usually

at a different site in the vein. Catheter change must

be performed by a nurse or physician skilled in

peripheral catheter insertion technique (174). Although the Intravenous Nurses Society (INS) standards of practice recommend that peripheral venous

sites be changed every 48 hours (174), recent studies

suggest that, barring other complications, peripheral

venous catheters can often remain in place for up to

72 hours (206). The 72-hour rotation schedule has

been widely adopted by HDIT providers (364). For

peripheral arterial catheters, the INS recommends

z my observerswo~d categorize vascular access devices as “supplies,” since they are generally intended for one-time use, but they are considered

equipment hem to distinguish them from the routine disposable HDIT supplies discussed later.

3 Assistance maybe required for dressing changes on peripheral catheters because the exit site is typically on the lower arm, precluding the use of

one of the patient’s hands.
Chapter 3-Home Drug Infusion Therapy Equipment and Services .47

less frequent site rotation (every 96 hours) due to the

more limited number of arterial access sites (174).

Certain factors may necessitate more frequent site

rotation for peripheral catheters. For example, a

patient receiving a particularly irritating drug may

experience painful swelling at the catheter site after

only a small number of doses (390). Some elderly

patients with poor venous access may experience

more rapid site deterioration than younger, healthier

patients (364).

Most peripheral catheters today are made of rigid

TeflonTM rather than steel. The rigidity of the

material sometimes contributes to mechanical phlebitis, an inflammation caused by irritation of the

surrounding tissues (154). Some newer peripheral

catheters are made of a polymer that expands to the

required diameter after it is in the vein, making

insertion less painful (141). The reported increased

comfort and lower risk of complications associated

with these catheters may reduce the frequency with

which they must be replaced (84,154,330).

This new technology highlights the difficulty of

adjusting protocols quickly to reflect new products

and techniques. Some home infusion companies are

hesitant to use the new catheters; others use them but

replace them at the recommended intervals for

TeflonTM catheters; and at least one large home

infusion company reportedly has protocols that

allow the new catheters to be left in place for up to

14 days if there are no complications (84,141 ).4

For HDIT patients, it is generally the nurse who

is responsible for deciding when peripheral catheters

should be changed. The decision to leave a catheter

in place for a longer or shorter period than the

recommended standard is based on an assessment

that includes consideration of the condition of the

current catheter site, availability of new sites,

condition of the patient’s skin, type of drug, and

expected duration of therapy (141).

Central Catheters

Drugs that are potentially toxic or irritating to a

vein must be introduced into a large volume of

blood, to dilute the drug and reduce the likelihood of

blood vessel damage. These drugs are delivered by

way of a catheter whose tip rests in a large central

vein such as the subclavian vein or the superior vena

cava (which feeds directly into the heart). Central

catheters require especially meticulous care by the

patient or caregiver to prevent infection at the open

site where the catheter enters the body, but they

usually require less frequent skilled nursing intervention than peripheral catheters. Routine site changes

are not necessary with central catheters, and patients

can use both hands for catheter care procedures.

Another advantage of central over peripheral catheters is that patients are spared the discomfort of

repeated venipuncture, because central catheters can

remain in place much longer (145). The implantation

of a traditional central catheter is a minor hospital

surgical procedure that must be performed by a

physician (161). Placement of the tip of the catheter

must be confirmed by x-ray.

Central catheters may be appropriate not only for

drugs requiring greater dilution, but for long-term

infusions of other drugs, for patients needing infusions of multiple drugs,5 for patients likely to need

repeated episodes of infusion, and for patients with

peripheral veins unsuitable for repeated puncture

(140,145).

The two traditional types of central catheters are:

●

●

Nontunneledcatheters (e.g., Hohn, subclavian),

which are inserted through an opening in the

neck or shoulder directly into the vasculature

(blood system). The tip of the catheter rests in

a large vein near the heart-either the subclavian vein or the superior vena cava.

Tunneled catheters (e.g., Corcath, Hickman,

Broviac), which are inserted into the chest wall

and are tunneled through the skin several

inches before entering the vasculature.

Tunneled catheters are used commonly in home

patients because they are associated with a lower

risk of infection and are easier to care for (260).

A relatively recent addition to the menu of

catheter choices is the peripherally inserted central

catheter (PICC line), which is being used increasingly in the home setting (50). The PICC line is an

alternative to both surgically placed central catheters

and traditional peripheral venous access. In this

4 The use of these new catheters has not yet been reflected in recognized standards of practice, which still state that peripheral lines should be changed

every 48 hours (174).

5 Centrrd catheters come in single- or multiple-lumen styles. Each lumen is a separate path tiough which a drug can be administered. Multiple-lumen

catheters facilitate multiple infusions and, in some cases, allow for continuous venous pressure monitoring during and between therapy (264).
48. Home Drug Infusion Therapy Under Medicare

case, a long catheter is inserted into a small vein,

usually in the forearm, and threaded up the vein

toward the heart (50). The catheter is anchored with

a suture or special tape at the exit site in the arm; like

the exit site of a surgically placed central catheter,

this site requires meticulous care to prevent infection

(140,145). Unlike other modes of central venous

access, placement of the PICC line does not necessarily have to be performed by a physician; in most

States, specially trained nurses can insert it. Because

the specific point of placement of a PICC line is

crucial, proper placement should be confirmed by

x-ray (50,174).

PICC lines are sometimes favored over traditional

peripheral catheters because they allow for greater

dilution of the drug and do not have to be changed

as often. Complications of PICC line insertion can

include tendon or nerve damage, bleeding, cardiac

arrhythmias, chest pain, respiratory distress, catheter

embolism, and malposition of the catheter (50).

However, many consider these complications to be

fewer and less severe than those associated with

traditional central catheter implantation and use

(50). Furthermore, the risk of an air embolism (see

ch. 2) is decreased because the line is maintained

below the heart.

The quality and safety of PICC line use in the

home setting depends on the skill of the health

professional who inserts and maintains the device

PICC. Safety also depends on the ability of the

health professional, patient, and/or caregiver to

properly care for the PICC line and recognize related

complications.

For some medications, the peripherally inserted

catheter need only be threaded up to the large vein

in the upper arm to achieve adequate dilution. When

this method of placement is used, the catheter is

referred to as “midline’ and radioscopic confirmation of placement is not usually necessary (50). As

with the PICC line, midline insertion can be

performed either by a physician or (in most States)

a nurse specialist at the patient’s bedside (174).

Although midline catheters allow for greater dilution of the drug than traditional peripheral catheters

and are frequently left in place for considerably

longer periods of time (141), they are still considered

peripheral lines by the INS for purposes of maintenance and replacement (i.e., INS recommends replacement every 48 to 72 hours) (174).

PICC lines and midline catheters are made of one

of three materials: polyurethane, which is rigid but

softens once in the vein; silicone elastomer, which is

very soft and must be inserted through a needle or

another TeflonTM catheter; and elastomeric hydrogel, which is rigid but both softens and expands once

in the vein (140).

Totally Implantable Catheters

Because they exit through an opening in the skin,

all of the above types of central catheters are

accompanied by the risk of infusion-related phlebitis

and infection. To reduce these risks, totally implantable catheters were developed for patients on

long-term infusion therapy (396).

Totally implantable catheters, also known as

subcutaneous ports, consist of a small reservoir that

is surgically implanted under the skin and tunneled

to a catheter. The catheter itself may lead to a central

vein, a large artery, or into the intrathecal or epidural

space (174). The side of the port facing the skin

consists of a self-sealing septum. The port is

accessed by a special needle designed for this

purpose which is inserted through the patient’s skin

into the septum. If desired, the needle can remain in

place up to 7 days at a time, at which point it is

changed by the patient or a nurse to minimize the

risk of contamination (174). The drug is infused

through the needle into the port and thence into the

catheter (80,145).

Like other central catheters, subcutaneous ports

are appropriate for patients on long-term therapies

and those for whom peripheral infusion is unsuitable

(145). One disadvantage is that the patient’s skin

must be punctured at least once a week. Also,

although the need for surgical replacement due to

catheter site infection is reduced, the port itself must

be replaced approximately every 2,000 punctures

(about once every 5 years if punctured once a day)

(145).

Access Devices for Other Modes of Drug Delivery

For patients with relatively short-term needs for

infusion, or who for some reason are unsuitable for

alternative modes of access, some drugs may be

infused by way of a needle that is simply inserted

under the skin. Subcutaneous infusion is limited to

drugs that require administration of a relatively low

volume of fluid over any given period of time (see

ch. 2). Narcotics to manage pain in patients with

advanced cancer, for example, can be administered
Chapter 3-Home Drug Infusion Therapy Equipment and Services ● 49

by continuous subcutaneous infusion. When infusion is continuous, needles should be changed every

48 hours (174).

Narcotics to manage pain may also be delivered

directly into the epidural or intrathecal spaces

surrounding the spinal cord. In either case, a catheter

is inserted between the vertebrae and threaded

several inches up along the spinal cord in a minor

surgical procedure (326). The procedure is performed by a physician and may be done in the

hospital or in an ambulatory surgical setting. As with

central venous catheters, epidural and intrathecal

catheters may be connected to a subcutaneous port

or tunneled under the skin to an exit on the side of the

body. Patients with intrathecal catheters intended for

long-term use may have the catheter connected to a

implanted infusion pump, requiring no external

apparatus at home at all and greatly reducing the risk

of infection (326).

For a given HDIT provider, the proportion of

patients with a particular type of vascular access

device is a function of both patient needs and

characteristics and the provider’s preference for and

expertise in the use of certain devices. For example,

providers who serve pimarily terminal cancer and

parenteral nutrition patients may use surgically

implanted central catheters almost exclusively, while

providers of shorter-term antibiotic therapies may

use peripheral catheters more frequently (364).

PICC lines have become the device of choice for

some providers, while others do not use them

because their staff are not trained in PICC line

insertion and maintenance (364).

Infusion Devices

Any drug infusion requires some kind of device

that controls the rate at which the drug enters the

body. Infusion devices used in home therapy today

range from simple gravity drip systems to highly

sophisticated programmable electronic pumps. The

choice of an infusion device depends on both

therapy and patient characteristics. Some IV therapies can be delivered safely and effectively through

gravity drip systems, while others require the

increased control, positive pressure, and greater flow

rate range offered by electronic pumps.

Gravity Drip Systems

The simplest infusion device is the “gravity

drip”: the bag or bottle is hung on a hook or pole

above the level of the patient, and fluid flows by

gravity down the line and into the catheter. The rate

of flow in a simple gravity drip system is controlled

primarily by a special clamp or valve on the line that

can be manually adjusted to permit the prescribed

amount of fluid to flow through (usually described

in drops per minute). These devices range in

complexity and ease of operation from roller and

slide clamps to more sophisticated rotating valves.

Compared with slide and roller clamps, rotating

valves are less awkward to manipulate and provide

a more consistent flow rate (264). Even the most

sophisticated manual drip valve, however, cannot

offer precise flow control, because the viscosity of

the solution being infused (the infusate) affects the

volume of each drop and hence the rate of flow

(264). The size of the needle at the end of the line,

through which the fluid flows into the catheter,

offers a second flow control; the smaller the needle,

the slower the maximum rate of flow into the body.

Controllers can provide an added measure of

security against uneven or ‘‘runaway’ flow of

infusate in a gravity drip system (264). These

electronic devices use a drop sensor to monitor flow

rate and can detect infiltrations and malpositioning

of the catheter or IV tubing by measuring backflow.

An alarm sounds when flow rate is altered or when

backflow is detected (264).

The gravity drip is conceptually simple, cheap,

and requires less equipment than most other infusion

systems. In the home setting, however, it has some

limitations. First, it is difficult to maintain a constant

infusion rate in a gravity drip system due to factors

such as the decreasing volume of fluid in the bag

(i.e., the infusion rate will decrease as the bag

empties) and changes in the shape of the tubing

around the clamp (264). Consequently, a gravity

system may provide insufficient flow control for

drugs that require a very slow, very precise, or very

long infusion time, such as antineoplastic (103).

Second, errors in using the gravity drip that remain

unnoticed can result in serious complications. For

example, if the clamp malfunctions or the flow rate

is improperly set, a drug may flow virtually unrestricted into the body, giving rise to severe adverse

drug reactions and other complications.
50 ● Home Drug Infusion Therapy Under Medicare

In addition, a gravity drip system may be an

inappropriate choice for certain patients due to

functional limitations of the patients or their caregivers. Because the IV bag is suspended well above

the catheter site in this system, patients with

decreased mobility may have difficulty changing the

bag. Ambulatory patients on continuous infusion

may also find gravity drip frustrating because the

system is not easily portable.

Despite the drawbacks of this traditional method

of IV administration, it does maintain some important fuctional advantages over more the expensive

electronic infusion devices discussed below. Because the drugs are forced into the vein under the

pressure of gravity alone, there maybe less irritation

at the catheter site, especially peripheral catheter

sites (390). Gravity drip systems may also be

preferred for patients who are confused by and

resistant to learning how to use more complex,

computerized drug delivery systems.

Infusion Pumps

The availability of an electronically controlled

device that could deliver constant and precise

amounts of fluid over time was a major technological advance in infusion therapy. Although many

therapies can be delivered safely and effectively via

gravity drip systems, others require the highly

precise and constant flow rate offered by electronic

infusion devices (103). For example, intraarterial

infusions usually require positive pressure pumps

because the back pressure is higher in arteries than

in veins (397).

Most infusion pumps work by peristaltic action—

i.e., by alternately squeezing and releasing the tube

containing the fluid to force the fluid through at a

predetermined rate. A second type of pump uses a

syringe-type pushing action to force the drug down

the tubing. Most infusion pumps used in HDIT are

modern, sophisticated versions of one of these two

types of pumps (103).

With the advent of home infusion therapies in the

1980s has come the development of small, portable

pumps with specialized uses for particular types of

therapies and adaptations for use by nonprofessionals. Because computerized pumps can deliver medication at a wide range of dose frequencies and

intensities, they broaden the scope of therapies that

can be safely and effectively administered at home.

Pumps specifically for the infusion of narcotics to

treat cancer-related pain, for example, may have

adaptations that provide a low level of ongoing

infusion but also permit patients to dose themselves

with bursts of medication when pain becomes

intense, up to a preprogrammed number of such

extra doses per day (215). Other pumps, designed for

the volume of fluid typical of most antibiotic

therapy, can be preprogrammed to deliver infusions

at standard intervals (e.g., 4 times per day), thus

enabling patients to sleep undisturbed while receiving therapy (215). Pumps used for long-term IV

nutrition administration, on the other hand, may be

designed to administer the large volume of fluid

required for the overnight infusions typical of

patients receiving this therapy (103,283). One syringetype pump permits the simultaneous administration

of several different therapies at different intervals,

with dosages and administration regimens preprogrammed on a microchip which fits in the back of the

pump (86).

Pumps currently available for home use range in

complexity and sophistication from very simple,

single-medication stationary infusion pumps to fully

programmable, ambulatory pumps that can deliver

multiple medications and are equipped with a

variety of alarms, bells, and other ‘failsafe’ mechanisms (103). While stationary pumps may be appropriate for patients who are bedridden or whose

medications are delivered over shorter periods of

time, ambulatory pumps provide greater independence for patients on continuous, frequent, or longterm therapy regimens. For example, ambulatory

pumps enable patients to receive antineoplastic

therapy continuously while engaging in normal

daily tasks. Many pumps also have automatic

“piggyback” mechanisms that control secondary

infusions at an independent rate, decreasing the

nursing time required for multiple infusions (103).

Infusion pumps do have certain disadvantages. If

patients, caregivers, or even health professionals

find the level of sophistication of these pumps

confusing, the patients’ safety could be jeopardized

through misuse of equipment (103). Many patients,

and the nurses who instruct and care for them, might

prefer simpler models that are easier to operate. Even

many hospital nurses are unfamiliar with or unaware

of sophisticated features of pumps they use on a

regular basis (103). Highly sophisticated pumps cost

more and often require considerably more training

for both the health professional and the patient than

simpler models (283).
Chapter 3-Home Drug Infusion Therapy Equipment and Services .51

New types of electronic infusion pumps are

constantly evolving, widening the menu from which

providers must choose and which patients and health

professionals must learn to operate. For example,

one recently developed pump uses a built-in scanner

to self-program, based on a bar code on the bag of

infusate, thereby eliminating the extra step of

manually programming the pump (40). Another

device currently under development is a watch-sized

delivery system for low-volume therapies such as

pain management and antineoplastics (228).6

Elastomeric Infusers

Elastomeric infusers are recently developed devices that can be used as substitutes for infusion

pumps. These infusers consist of disposable containers with inner elastic bladders that can be filled with

the medication. The devices are sold empty and are

filled by the pharmacist through a port at the top of

the bladder (28,29,40). The drug flows through an

opening at the base of the bladder membrane and

into the tube leading to the patient. The force of the

flow, and thus the rate of infusion, is determined by

the elasticity of the bladder (which pushes inward,

delivering the drug under positive pressure) and the

concentration of the drug in the infusate, regardless

of whether the bladder is above, below, or on level

with the IV site (28,29,40). Different drugs and

dosages require devices of differing size and bladder

membrane composition.

Most devices currently on the market are designed

for either antibiotic or antineoplalstic therapy administration. They can be used for IV, intraarterial,

and subcutaneous administration of drugs (28). A

patient on a twice-a-day regimen of home IV

antibiotics would use two infusers per day, while a

patient on continuous antineoplastic therapy might

use a single device for several days at a time (28).

Some devices allow patient-controlled administration of bolus doses above and beyond the continuous

infusion rate. A disadvantage to the use of these

devices for patient-controlled analgesia is the lack of

a memory function that can record the frequency of

patient-requested bolus doses, like that found in

some electronic infusion pumps (see above). Bladder devices are also not appropriate for multiple drug

regimens.

According to one home infusion provider, the

availability of disposable elastomeric infusion devices has increased the feasibility of home-based

care for disabled elderly patients (249). Like sophisticated electronic infusion pumps, these devices can

deliver a precise dose over a specific period of time.

However, because they are self-contained and much

simpler to operate, they may be less confusing for

patients who are uncomfortable with high-tech

equipment. The patient or caregiver need only hook

the device to the catheter at dosing time and

disconnect and dispose of it when the dose has been

completed.

Implantable Pumps

Some therapies that require very small drug

dosages can be administered by way of totally

implantable pumps. Examples include insulin delivery, continuous epidural morphine administration

for chronic pain management, and continuous venous antineoplastic therapy infusion for liver cancer

patients (the catheter is threaded into the portal vein

leading to the liver). Due to the limited range of

conditions for which they are currently used and the

much lower intensity of services required, however,

they are not discussed further in this report. The only

service directly related to infusion therapy for these

devices is refilling of the pump’s reservoir, which

may be done weekly or even less frequently in a

medical outpatient or home setting (260).

Techniques and Supplies

The supplies and skills needed for HDIT depend

on the type of therapy being administered, the

vascular access device, and the infusion device. This

section describes procedures associated with the use

of different types of home infusion equipment and

the supplies required for those procedures.

Some supplies are needed by nearly all patients on

HDIT, although specific amounts vary depending on

the patient (table 3-l). Examples of general HDIT

supplies include such items as special soaps, swabs,

catheter clamps, and sterile gloves.

Other supplies relate to specific HDIT procedures

(table 3-1).7 A patient receiving antineoplastic

therapy, for example, needs special containers to

6 The system includes a miniature progr ammable pump that operates electrolytically rather than by peristaltic orsyringe-pump action. A weak electric

current causes gas in a tiny reservoir to expand, thereby expelling the drug from a neighboring chamber into the catheter (228).

7 The specitlc supplies listed in the table reflect the practice of this particular infusion company. Other providers may use different supplies.
52 ● Home Drug Infusion Therapy Under Medicare

Table 3-l—Typical Suppliesa in a Delivery by One Company for Four Types of Home Infusion Therapy

Type of therapy

Central catheter Peripheral catheter

Pain Continuous infusion Antibiotic Hydration

managementb

antineopiastic therapybtherapy therapyb

Suppliesa(1 dose/5 days) (1 dose/5 days) (2 doses/day) (1 dose/day)

Drug administration

Intravenous (IV) pump (monthly rental) . . . . . .

Pump cassette (100 ml) (5-day) . . . . . . . . . . . .

Battery, 9VC . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Disposable elastomeric pump. . . . . . . . . . . . . .

Gravity drip flow regulator (disposable) . . . . . .

IV pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

IV administration set, 96 inch . . . . . . . . . . . . . .

IV administration set, 66 inch . . . . . . . . . . . . . .

IV in-line filter set, 1.2 micron . . . . . . . . . . . . . .

Extension set, 6 inch . . . . . . . . . . . . . . . . . . . . .

Extension set, 30 inch . . . . . . . . . . . . . . . . . . . .

Extension set, 36 inch . . . . . . . . . . . . . . . . . . . .

Catheter clamp . . . . . . . . . . . . . . . . . . . . . . . . . .

Peripheral catheter kitd 

. . . . . . . . . . . . . . . . . . .

IV catheter, 22 gaugee 

. . . . . . . . . . . . . . . . . . . .

Click lock needles. . . . . . . . . . . . . . . . . . . . . . . .

Needles, 21 gauge X 1 . . . . . . . . . . . . . . . . . . .

1

7

4

1

7

4

—

—

—

7

7

—

—

—

—

2

—

—

8

—

—

—

—

—

— 56

28

1

28

—

.

—

—

—

—

—

— —

7

7

2

—

—

—

—

4

—

—

— 4

8 —

— 56 28

Catheter/site care

Alcohol preps (box) . . . . . . . . . . . . . . . . . . . . . .

lodine preps (box) (central line only) . . . . . . . .

Antiseptic hand cleanser, 8 oz. bottle . . . . . . . .

Sterile gloves . . . . . . . . . . . . . . . . . . . . . . . . . . .

Antiseptic table wipes (for work area) . . . . . . .

Disposable sterile work surface . . . . . . . . . . . .

Dressing change kit (central line only) . . . . . . .

Tegaderm dressing medication . . . . . . . . . . . . .

Tape, plastic 1 inch wide (roll) . . . . . . . . . . . . . .

SASH kits (for catheter flushing)f 

. . . . . . . . . . .

Injection caps, click lock. . . . . . . . . . . . . . . . . . .

Other

10 cc syringe with needle (for drawing blood) .

Sharps container/disposal . . . . . . . . . . . . . . . . .

Anaphylaxis kit . . . . . . . . . . . . . . . . . . . . . . . . . .

Chemo spill emergency kitg . . . . . . . . . . . . . . .

Chemo waste bag . . . . . . . . . . . . . . . . . . . . . . .

Chemo protection kith.... . . . . . . . . . . . . . . . . .

1

1

1

8

7

7

12

12

1

7

12

1

1

1

8

7

7

12

12

1

7

12

1 1 —

1

56

56

56

—

1

28

28

28 —

9 to 12

1

56

9 to 12

—

9 to 12

1

28

9to12

4

1

1

4

1

1

1

2

1

4

2

1

4

1

—

— —

—

asupplies may va~ depending on individual patient characteristics and needs. Does not include drugs or therapeutics.

bsuwlies list~ are for a j-month r~imen of the following therapies: pain rnanagemenf-rnorphine sulfate approximately 100 mg *se *iM

antibioti~efobid 1 g twice daily; hydrath+dextrose 0.45 percent in 1 liter saline once daiiy; chemotherqy+luorouracil 2500 mg/50 ml every 5 days

continuous infusion.

~he antineoplastic therapy and pain management pumps need 9-volt batteries for backup power.

d[n~~esallsupplies rquir~todothree [Vrestarts (~theter, SASH kit, n~d[es, etc,).Theseare usuallype~orm~ every Sdays, although antibiotic patients

may require more frequent restarts due to irritation.

eFor hydration therapy, the full peripheral catheter kit is not rSCIUirSd.

fSASH -saline.administration-saline-hepa~n. These are prepa~ag~ ~ts us~ for period~ flushing of ~theters. Some infusion therapy providers choose

to use heparin alone rather than a SASH kit (see box 3-B).

91ndudes special towels, goggles, warning signs, etc. in the event of a spill.

hus~ by nurse, patient, or other caregiver who administers antineoplastic therapy.

SOURCE: S. Wyremski, Abel Health Management Services, Inc., Great Neck, NY, personal communications, Jan. 18 and 22, 1991.

ensure that the wastes associated with the therapy with a 7-day cassette for continuous antineoplastic

are suitably disposed of. A patient with a small, therapy. A patient with a subcutaneous port requires

ambulatory pump may not require an IV pole to hang specially designed needles that do not puncture the

the pump, but he or she may need the special base of the port.

drug-containing pump cassettes. A patient on a

2-dose-per-day course of antibiotics needs 14 times Most supplies fall into two categories: those used

as many dose administration supplies as a patient to prevent infection, and those needed to actually
Chapter 3-Home Drug Infusion Therapy Equipment and Services .53

Box 3-A—Aseptic Technique

To minimize the risk of infectious contamination in home infusion therapy, aseptic technique must be used

each time the catheter site is exposed or the catheter or tubing is accessed. Examples include dressing changes, IV

administration set changes, drug administration, and catheter care procedures (e.g., catheter flushing). The aseptic

technique requires:

. A clean, disinfected work area (disposable sterile work surfaces can be used for extra protection).

● Meticulous handwashing with a disinfect soap before performing any home infusion therapy procedure.

● Care in handling syringes so the hands do not come in contact with the sterile needle or the lower part of

the syringe plunger.

. Care in use of needles. When needles are used to access catheters or administration sets via external or

subcutaneous injection ports, or are inserted directly into the skin for subcutaneous infusions, they must be

fully engaged up to the hub and taped securely to the patient to prevent in-and-out motion of the needle from

introducing bacteria into the vascular system.

* Disinfection and cleaning of injection ports (if they are used) prior to access with a needle.

. Use of sterile gloves for catheter site care and dressing change.

. Metculous care of the catheter site, which should be cleaned three times in an outward circular motion with

an alcohol swab, using a new swab each time, and then with three providone-iodine swabs in the same

pattern. Sterile gauze can be used to gently pat the site dry. After applying the new dressing, catheter tubing

should be resecured with tape to prevent motion.

SOURCES: A.L. Plumer, “Baeterial,Fung@ and Particulate Contamma“ tiom” inPrinciplesandPractice ofIntravenowr Therapy, 4th Ed., A.L.

Plumer and F. Cosentino (eds.) (New YorlG NY: Little, Brown and Co., 198’7); National Medieal Care, Inc., Homeeare Division,

Central Line Catheter Care: Patient Znfomation Guiak (WalthauL MA: National Medieal Care, IQC., 1989).

administer the drug. These are discussed in more aseptic technique requires ample backup supplies,

detail below.8

Infection Control

The three main sources of microbial (bacterial and

fungal) contamination that can cause infusionrelated infection are the skin, the air, and the blood

(264). Although risk of infusion-related infection

can be reduced by minimizing exposure of the

catheter site, the administration set, and the container of infusate to these sources, exposure cannot

be eliminated. To further reduce the risk of contamination, additional steps must be taken.

The most important method of controlling the risk

of infection, whether at home or in the hospital, is the

aseptic technique (see box 3-A). This technique

must be applied to all procedures that involve

exposure of any part of the infusion administration

assembly (catheter site, catheter lock, tubing, etc.) or

of any infused substances to the environment (264).

These procedures include drug compounding and

mixing, drug administration, peripheral site changes,

catheter flushing, dressing changes, and administration set changes (see below). Strict adherence to the

because if a piece of sterile equipment (e.g., administration set tubing, catheter cap, injection port,

syringe plunger) is accidentally contaminated it

must be discarded and replaced with a new one.

Another factor that can increase the risk of

infusion-related infection is the use of multiple-dose

vials of drugs for home administration. Because

multiple-dose vials must be accessed repeatedly,

they increase the risk of contamination from environmental sources. They may also be more susceptible to tampering by patients or other individuals who

handle them (207). To minimize the risk of infection

and tampering, some hospitals and home infusion

companies use single-dose vials of drugs that are

discarded after each administration (207,364). Inline bacterial and particulate filters and simplified

catheter flushing procedures are additional infection

control measures (see below).

Drug Administration

The supplies used in drug administration depend

on the delivery system being used.9 Most patients

have separate tubing-the administration set—that

8 Although peripheral and midline catheters are treated in this chapter as equipment, they are usually considered supplies because they are not

reusable.

9 patien~ who use elastomeric bladder devices may not need additional administration tubing because the bladder pump comes with ~bing.
54 ● Home Drug Infusion Therapy Under Medicare

connects the infusion device to the catheter. Administration sets, which come in varying lengths and

configurations, must be changed on a regular basis

to prevent infection, clogging, and harmful drug

decomposition or interaction (174). Some administration sets have special extensions for ‘piggyback’

infusions, where a second drug is administered

through a Y-gap at the patient’s end of the administration set, thereby avoiding mixture of the two

drugs in the tubing. Many electronic infusion

devices require administration sets that are designed

specifically for that pump (103). Extension tubing is

also available to increase the patient’s mobility

during drug administration.

The INS recommends that administration sets be

changed at least every 48 hours (174). However,

some types of drugs and drug regimens require that

tubing be changed with every new drug administration (15).10

Injection ports are rubber caps that are attached to

the administration set or directly to the catheter and

are used for the periodic injection of drugs or other

solutions into the vascular system (174). Ports that

are integral to the administration set are changed

whenever the administration set is replaced. Ports

attached to peripheral catheters should be replaced

whenever the catheter is changed, and ports on

central catheters should be changed at least every 7

days (174).

In-line filters may be attached to administration

sets to prevent air, particulate matter, or bacteria

from entering the vascular system and causing

infection or other complications. The costeffectiveness of using in-line filters has been the

subject of some debate (5,107,117,147,277), and

practices vary among HDIT providers (3,15). INS

standards, however, advocate their use inmost cases

(174).

The type of filter needed varies depending on the

therapy. A small (0.2 micron) filter is recommended

for routine use in most IV therapy because it

prevents bacteria as well as air and particulate matter

from entering the vein (174). Transfusion of blood

and blood products requires special falters, with a

separate filter used for each unit of blood product

transfused so that signs of contamination can be

traced to a specific unit. Special surfactant-free

filters are required for intraspinal infusion of any

medication (174).

Some in-line falters are add-ens that must be

attached to the IV administration set; others are

integral to the infusion device or the IV administration set itself. The INS recommends that in-line

falters be changed each time the administation set is

changed (every 48 hours) (174). A recent study,

however, found that some disposable in-line antimicrobial filters lose their ability to retain bacteria after

24 hours (27), indicating that more frequent change

might be appropriate.

Catheter and Site Care

Patients with either central or peripheral vascular

access must care for their catheters and the site

where their catheter exits the body in order to

minimize risk of catheter malfunction (e.g., clogging

or breakage), site irritation, and secondary infection.

The following are typical methods used to accomplish this care.

●

●

●

Catheter protection—To protect a catheter

from contamination between doses, special

cannula caps are used. The INS recommends

that these caps be replaced whenever they are

removed to minimize risk of infection (174).

Catheter site care—The INS recommends that

the bandages (dressings) that cover the exit site

of a catheter be changed at least every 48 hours

or whenever they are soiled, wet, or loose (174).

Dressing changes can be conveniently performed by the patient or caregiver at the same

time as administration set changes. When

dressing change coincides with rotation of a

peripheral IV site, it may be performed by the

skilled nurse. For subcutaneous ports, dressings need only remain in place when the port is

accessed by a needle.

Catheter flushing-AIl catheters are susceptible to clogging either by the patient’s own

blood or by other deposits (174,396). For this

reason, most catheters are flushed periodically,

most commonly with saline (salt solution) or

with heparin, an anticoagulant.11 Catheters are

10 For eqle, when two incompatible drugs are infused through the same catheter, the admirds-tion Set mUSt be C~ged between ~gs (174).

Also, some drugs with limited periods of stability may form precipitates after a certain number of hours (15). When these drugs are being infused, IV

administration tubing must be changed with every new drug admns ‘ “ tration (15).

II Hepfi is used because it is the only soluble anticOa@ant.
Chapter 3-Home Drug Infusion Therapy Equipment and Services ● 55

Box 3-B-Controversy Over Catheter Flushing Methods

The issue of saline v. heparin v. SASH (saline-administration-saline-heparin) flushing is one of considerable

debate, and literature exists to support the relative efficacy and cost-effectiveness of each method (18,72,104,124,144,

166,245,337). There is as yet no consensus on which method is most appropriate, and practices vary among

providers (36). Current published standards suggest that the SASH method should be the exception rather than the

rule (174). However, some home infusion providers use the SASH method with every type of therapy because they

believe it results in decreased complications (36,402).

One argument against the use of the SASH procedure (as opposed to heparin or saline alone) as a default for

catheter flushing is that it increases the risk of infection because it necessitates multiple accesses to the catheter lock

(36). Risk of conlamination may also be increased when catheter flushing substances are provided to the patient in

multiple-use vials. Although some home infusion therapy providers supply patients with a larger vial of heparin

solution from which they fill their own syringe for each flushing procedure (181), most providers use prefilled

syringes to avoid increased risk of contamination and to simplify the procedure for the patient (181,402). One

medical equipment company has recently introduced a closed, 3-chamber SASH flushing system that reduces to

one the number of catheter accesses required (40). Some catheters are pre-heparinized or have special valves at each

end that minimize the backflow of blood into the catheter, decreasing the need for flushing (138,260). 1

lfih~catheters eanonly be used inpatients whoarenot sensitive to hoparirtandwith heparin-canpatibledr ugs. ‘lMwecatheters

may be routinely flushed with saline alone (260).

generally flushed after each administration of

medication and after the drawing of a blood

sample. When two incompatible drugs are

administered through the same catheter, or

when the drug being administered is incompatible with heparin, a special flushing procedure

called the SASH (saline-administration-salineheparin) method is often used. In this procedure, the catheter is flushed with saline before

and after administration of the drug to avoid

any contact with the heparin solution (174).

Catheter flushing supplies are often delivered

to the patient in prepackaged kits. There is

considerable variation among providers in the

flushing methods they recommend to patients

(see box 3-B).

. Catheter clearance—The risk and expense of

surgically replacing a clogged central catheter

can sometimes be avoided by using urokinase,

an enzyme that helps degrade clots and restore

catheter patency (2). The urokinase is injected

into the catheter using a syringe and allowed to

sit for several minutes before the catheter is

aspirated to remove the clot (2). This procedure

must be performed by a skilled nurse or a

physician (260).

Table 3-2 describes variation in the frequency of

procedures required by HDIT patients with different

types of vascular access devices and therapeutic

regimens.

Certain therapies require special techniques and

supplies. For example, home transfusion patients

may need special warmers to bring blood products to

normal body temperature prior to infusion (174).

Patients on antineoplastic therapies need special

supplies to protect them from exposure to these toxic

drugs when performing routine catheter maintenance or drug administration (174). Patients on

intraspinal therapy need special diluent solutions

and in-line filters because many preservatives,

stabilizing agents, antioxidants, and surfactants12

typically found in dilutents and filters can cause

nerve damage if they enter the intraspinal area

(100,202).

Services and Staffing

HDIT involves a broad range of services, including patient screening and assessment; patient training; and ongoing medical, pharmacy, nursing, laboratory, delivery, and coordination services. These

services, in turn, are performed by a variety of health

professionals, including registered nurses (RNs),

RN specialists (e.g., IV, oncology, and critical care

12A surfaetant is a substance added to a solution to redu~ surface tension of the fluid. The use of Surfactant-containing antimicrobial or pticUlate

filters on intraspinal adxninistration sets is strictly contraindicated because surfactants often contain alcohol (202).
56. Home Drug Infusion Therapy Under Medicare

Table 3-2—Recommended Routine Frequency of Selected Catheter Maintenance Procedures Performed for

Home Infusion Therapy Patients, by Type of Vascular Access Devicea

Procedure

Catheter Needle Catheter Dressing Administration

Vascular access device Changeb Changecflushingdchangeeset Changef

Peripheral catheter

Venous . . . . . . . . . . . . . . . . . . . ● 48 hours NA Variable 48 hours 48 hours

Arterial . . . . . . . . . . . . . . . . . . . ● 96 hours NA Variable 48 hours 48 hours

Midline catheter . . . . . . . . . . . . . ● 48 hours NA Variable 48 hours 48 hours

Central venous catheter

Tunneled catheter . . . . . . . . . . NA NA Variable 48 hours 48 hours

Nontunneled catheter . . . . . . . NA NA Variable 48 hours 48 hours

Peripherally inserted central

venous catheter . . . . . . . . . NA NA Variable 48 hours 48 hours

Totally implanted catheter . . . . NA 7 days Variable NA NA

Subcutaneous Infusion . . . . . . NA ● 48 hours NA 48 hours 48 hours

NOTE: NA = not applicable. Asterisks (*) indicate that this procedure can only be performed by a qualified health professional-usualiy a registered nurse.

Some procedures may be performed by a nonskilled person (e.g., patient orcaregiver). In manycaaes, the functional ability of the patient determines

whowill perform thetask. In eomecaaea,the patient’smedical condition may besuchthatskilled personnel are requiredtoperform what would normally

be nonskilled functions (e.g., a dressing change if the catheter site shows signs of infection). Nonskilled procedures may also be performed by skilled

staff in conjunction with skilled procedures (e.g., a dressing change when a peripheral catheter site is rotated).

aFrquen~W refl=t r~mme~ations of the Intravenous Nurs~ ~iety in i~ revis~ standa~ of practice for intravenous nursing (both in inpatient and

outpatient settings). Actual frequency of procedures may vary among providers.

%atheters other than peripheral or midline are not routinely changed, but change maybe necessary if an infection or malfunction occurs.

~he needles on implanted catheters can remain in placs for up to 7 days, and all infusions and heparin flushing can be achieved through that needle.

%athetersaregenerally flushed after each administration of medication andafterabloodsample isdrawn; hence, flushing could occuras infrequentfyaaonce

aweekfor patients on continuous infusion or as often as fourtimes a day for patients on four times a day antibiotics. Frequency and type of flushing depends

on type of catheter and drug being used. When not in use, catheters require less frequent flushing.

eDressinW must also be changed whenever they become Soiied, Wet, or loose.

fForpatients on~ntinuous infusion of chemotherapy via an Infusion pump with a multipleday drug reservoir, set can be left in @aOe until re$ervoir is ~an9$d.

SOURCES: Intravenous Nurses Society, Intravenous Nursing Standards of Practice (revised 1990), Joumaf of Mravenous IVursirw Supplement 1990, APril . .

1990; OTAsite visits to providers, 1990-91. -

nurses), licensed practical nurses, nurses’ aides,

pharmacists,pharma cy technicians, and other on-thejob trained personnel. Because HDIT is a relatively

new mode of practice, providers generally look for

employees with extensive hospital infusion therapy

or pharmacy experience and rely heavily on in-house

training to prepare their staff for the specific

demands of HDIT patients (364). For some nurses

and pharmacists, HDIT practice is an attractive

career choice because it allows them to gain

independence and further their career in ways that

practice in other settings does not (364).

The distribution and coordination of responsibilities among HDIT staff depend on the organizational

structure of the home infusion provider, the capabilities of individual staff, limitations of State licensure

and practice acts, and size of the geographic service

area. For example, pharmacy-based providers often

utilize clinical pharmacists for patient assessment,

education, and clinical monitoring tasks (see box

3-C), while nursing-based providers place these

responsibilities in the hands of nurses.13 Small

providers with limited staff and a small service area

may have one pharmacist and one nurse as the sole

providers of services. Other providers may contract

with home health agencies or visiting nurses associations to provider nursing services to patients in

more remote areas (see ch. 4). Large, full-service

providers in concentrated metropolitan areas may

organize their many nursing personnel into teams

responsible for the care of a defined group of patients

and rely heavily on central coordination staff to

ensure that services are delivered properly and in a

timely fashion (box 3-C).

The next section describes in more detail the

specific services involved in HDIT and the qualifications, abilities, and availability of the staff who

provide those services.

13 See ch. 4 for a description of the different types of HDI’I’ pmvidem.
Chapter 3--Home Drug Infusion Therapy Equipment and Services .57

Box 3-C-Staffing and Organization of Home Drug Infusion Therapy Services:

Two Contrasting Models

Anne Arundel General Hospital Outpatient IV Therapy Services Program, Annapolis, MD

Outpatient specialists are pharmacy technicians with a minimum of 3 years’ hospital experience. Under the

supervision of pharmacist staff, they are responsible for patient training, care coordination, and preparation of all

IV medication in the outpatient center pharmacy facility.

The RN specialist, a registered nurse (RN) with extensive experience in hospital IV therapy, is responsible for

the initial patient assessment, some patient training, and all peripheral catheter insertions and changes. The RN

specialist also plays an active role in training outpatient specialists and any other health professionals who may

become involved in home IV therapy services (e.g., home health nurses who see homebound patients).

Clinical pharmacists are Pharm.D.s with hospital pharmacy experience and a minimum of 2 years’ experience

in a clinical setting. They are responsible for designing and monitoring therapy and examining patients in the

outpatient center three times per week, Although the pharmacists do not diagnose and treat patients, they do examine

patients and report any concerns immediately to the physician for further investigation. Pharmacists are also directly

involved in developing and prescribing therapy regimens, under the supervision of staff physicians.

The microbiologist performs and/or coordinates IV therapy-related laboratory work which is generally done

at the referring hospital.

Physicians see patients at least once a week in their offices or in the outpatient center and consult with the

pharmacist and other staff about patient progress, therapeutic changes and response, etc. A medical director is on

staff at the center.

ABEL Health Management Services, Inc., Great Neck, NY

Field nurses are primarily RNs with strong clinical skills and experience, although some are licensed practical

nurses (LPNs). Field nurses are organized in teams depending on their qualifications and availability. Each patient

is assigned a team of field nurses who share call duty. Each field nurse is equipped with a 4-wheel-drive vehicle,

car phone, fax machine, and 24-hour beeper. Field nurses average 6 to 8 patients per day overall, but the number

for any one nurse depends on geography and patient needs.

Patient education specialists are baccalaureate-prepared RNs who do initial patient assessments and initiate

the patient training process (field nurses finish it). They also train other staff in home infusion techniques.

Nursing care coordinators (NCCs) are baccalaureate-prepared RNs who serve as the point persons for all

communication from nursing, pharmacy, lab, and patients. They generally do not perform clinical functions.

Nurse managers are baccalaureate-prepared RNs who are responsible for overseeing the activities of NCCs

and managing and monitoring any problems that may arise.

Clinical pharmacists are registered pharmacists (R.Ph.s). They are responsible for coordination of all clinical

functions of pharmacy service, including receiving physicians’ telephone prescriptions, maintaining patient

medication profiles and checking for possible drug interactions, providing drug information to other nursing and

pharmacy staff, and reviewing patient lab work. They are recruited from both retail and hospita1 settings and undergo

8 to 10 weeks of initial training in infusion therapy techniques before assuming full staff responsibility.

Staff pharmacists are R.Ph.s who are primarily responsible for drug preparation and compounding.

Pharmacy liaisons are on-the-job trained personnel who act as support staff for staff and clinical pharmacists,

aiding in the preparation of drugs and facilitating communication between nurses, physicians, pharmacists, and

patients +

Other staff include customer service representatives (responsible for distribution of drugs, supplies, and

equipment), armed escorts for staff who serve patients in dangerous neighborhoods, and others.

SOURCES: Anne Arundel GeneraI Hospital Outpatient IV Therapy Services Prow Annapolis, MD, informational visit with O’J14 staff, Oct.

25, 19X$ ABEL Health Management Services, Inc., Great Neck NY, informational visit with OTA staff, Nov. 9, 1990.

297-913 0 - 92 - 5
58. Home Drug Infusion Therapy Under Medicare

Patient Screening and Assessment

Patient screening is perhaps the most critical

element in the decision of whether or not to

administer HDIT (see ch. 2), and it is the first service

an HDIT provider renders to a prospective patient. In

determining candidacy for HDIT, the provider must

consider the patient’s medical condition, the patient’s and caregiver’s willingness and ability to

perform self-care, and the environmental characteristics of the home setting. These considerations must

be balanced against both the demands and associated

risks of the prescribed HDIT regimen and the level

of services the provider itself is capable of delivering. At a minimum, patient assessment includes a

visit to the patient in the hospital prior to discharge,

in which the patient’s medical stability is evaluated

and where the patient is questioned about other

relevant aspects of the home and family environment. In addition, it may include a visit to the

patient’s home to confirm that the home environment is suitable (24). Patients who are referred from

outpatient care may receive their assessment visits in

a physician’s or provider’s office.

Although the actual assessment is usually performed by a nurse (364), other professionals (e.g.,

physician, social worker, clinical pharmacist, dietitian) may also participate (24,270,335). Box 3-D

provides an example of criteria that one home IV

antibiotic therapy program uses to screen patients.

Patient Characteristics

The overall condition—medical, physical, mental

-of a patient will affect the level and nature of care

required. Specific conditions that typically affect

administration of IV therapy in the elderly include

cardiovascular disease, poor venous access, thinning

of the skin and underlying tissues, diabetes, joint

disease, paralysis, effects of long-term use of certain

drugs, and poor response to acute disease processes

(62). Therapeutic decisions and patient safety may

also be complicated when a patient is taking other

drugs in addition to the prescribed therapy. HDIT

can only be safe and effective if the nurse and

pharmacist are aware of the patient’s individual

needs and (in conjunction with daily caregivers) can

anticipate and handle related complications.

Some elderly patients are fully capable of performing self-care and need only periodic skilled

nursing services to receive HDIT. Other patients

who normally require no assistance may have

Box 3-D—Patient Screening Criteria for

One Home Intravenous IV) Antibiotic

Therapy Program

Disease Criteria

. Infection responded clinically/clinically stable

. Has not had a fever for at least 5 days prior to

discharge

● Only in hospital for IV therapy

Treatment Criteria

. Good venous access

● Received and tolerated IV antibiotics in hospital

Patient Criteria

● Alert

● Cooperative

. Average intelligence

● Good motivation

. Reliable

. Emotionally stable

● Acceptable lifestyle/home environment

. Likelihood of compliance

● No history of mental problems or substance

abuse

. Understands therapy and gives consent

. Patient and one family member taught

. patient’s family agrees to therapy

● Adequate support system at home

● Completed IV training session

● Proficiency in IV techniques

● Can care for venous catheter and reliably

self-administer antibiotics

● Telephone and refrigerator at home

. Access to health area

● Transportation available

SOURCE: K. be and J.I). Andrews, “Assessment of the Need

for a Home Intravenous Antibiotic PrograuL” Canadian Journal of Hospital Pharmacy 41(6):295-301,

307, Deeember 1988.

specific fictional or cognitive problems that limit

their ability to perform the specific self-care procedures associated with HDIT. These patients require

more supportive services to make HDIT feasible and

safe.

Still other patients require assistance with normal

activities of daily living even without infusion

therapy due to certain conditions that are especially

prevalent among this population. For example:

● Eighty-six percent of elderly persons have one

or more chronic conditions, compared with 50

percent of the general population (361).
Chapter 3-Home Drug Infusion Therapy Equipment and Services .59

●

●

●

●

●

●

Dementia, which can limit both cognitive and

functional capacity, affects an estimated 15

percent of persons of 65 years of age or over,

compared with approximately 1 percent of

younger persons (336,339).14

Depression, which can also cause cognitive and

functional impairment, affects 2 to 10 percent

of the elderly (39,139).

Visual and auditory impairment, which can

limit a patient’s ability to learn and perform

self-care functions, are common among the

elderly. Nine percent of persons 65 years of age

or older are visually impaired, and 32 percent of

elderly persons are hearing impaired (4).

Orthopedic impairments or deformities, which

can limit a patient’s ability to perform self-care,

are present in 13 percent of the elderly compared with 8 percent of the general population

(361).

Within the population with chronic conditions,

the rate of functional limitations is much higher

for the elderly: 18 percent of elderly people

with chronic conditions reported limitation in a

major normal activity of daily living,15 compared with 4 percent of the general population

with such conditions (361).

Two-fifths of community-dwelling elderly 65

years of age and over report limitation in a

major normal activity of daily living, compared

with 14 percent of the total noninstitutionalized

population (361).

The patient’s role in HDIT will vary depending on

the type of therapy, venous access device, and drug

delivery device. Some drug delivery systems and

access devices require considerable manual dexterity and physical mobility to operate. For example, a

patient on a gravity drip system must be able to reach

the bag, remove it from the IV pole or hanger,

change the bag, and assemble anew set of tubing. A

bedridden patient with debilitating arthritis would be

incapable of performing these tasks. In the absence

of a capable caregiver, the patient could be put on an

automatic drug delivery system (e.g., a fully programmable infusion pump) that would greatly reduce the amount of effort required on the part of the

patient. Some patients, however, would be too

debilitated to operate even the simplest infusion

pump and would require assistance in drug administration either by an informal caregiver or a nurse.

A patient who is willing and physically able to

administer HDIT may still be unable to do so due to

cognitive barriers. For example, an impaired patient

who is instructed in central catheter care and

administration of his or her specific drug regimen

may be able to repeat the required procedures

perfectly right after training but may be unable to

repeat them on the following day.

If a patient is incapable of performing the required

self-care, a capable and reliable home caregiver must

be available for HDIT to be feasible. Even when the

patient is capable of self-care, an additional trained

caregiver can be an important backup mechanism

should the patient become temporarily or permanently unable to perform certain tasks (24,209,335).

For patients who require 24-hour attention (e.g.,

some terminal cancer patients), more than one home

caregiver maybe required for the safe administration

of therapy (246). Dysfunctional patients with no

available caregiver may be able to receive HDIT if

the risks of that therapy are not life-threatening, but

these patients will require considerably more paid

nursing visits (table 3-3).

Regardless of their clinical stability and objective

ability to perform the required tasks, some patients

may simply be unwilling to undergo treatment in the

home setting due to fear or discomfort with the

therapy, equipment, or associated risks. Unwillingness is an absolute contraindication to HDIT;

providers and the published literature unanimously

agree that safe and effective home therapy cannot be

provided to patients (or by caregivers) who do not

want to be on it. The right of the patient (or the

caregiver) to decline treatment in the home setting in

spite of the urging of other interested parties is an

issue of quality assurance as well as of patient rights.

Home Environment

In order to safely and effectively carry out HDIT,

a home must have certain basic features. These

include running water, electricity, refrigerator space

for drug and supplies storage, a clean area where

aseptic catheter and simple wound care can be

performed, and, perhaps most importantly, access to

a telephone for emergency and routine communica14 Includes moderate and severe dementia.

15 For example, hous&eeptig.
60. Home Drug Infusion Therapy Under Medicare

Table 3-3-Average Number of Nursing Visits Per Week for Home Infusion Therapy Patients, by Selected Types of

Vascular Access Device, Type of Therapy, and Functional Status of Patienta

Number of other nursing or assistive service

visits per week if patient/caregiver.c

Number of skilled can perform all cannot perform any

nursing visits drug administration drug administration

Type of vascular access device and therapy per weekband self-care tasks or self-care tasks

Peripheral or midline venous catheter

Hydration therapy once a day... . . . . . . . . . . . . . . .

Antibiotics three times a day. . . . . . . . . . . . . . . . . .

Tunneled or nontunneled central catheter or

peripherally Inserted central catheter

Hydration therapy once a day... . . . . . . . . . . . . . . .

Antibiotics three times a day . . . . . . . . . . . . . . . . . .

Continuous chemotherapy or pain

management with infusion pump. . . . . . . . . . . . .

Totally Implanted catheter

Hydration therapy once a day. . . . . . . . . . . . . . . . . .

Antibiotics three times a day . . . . . . . . . . . . . . . . . .

Continuous chemotherapy or pain

management with infusion pump. . . . . . . . . . . . .

Totally implanted pump . . . . . . . . . . . . . . . . . . . . . . .

Continuous subcutaneous morphine

Infusion with Infusion pump . . . . . . . . . . . . . . .

2 to 3 0 7

2 to 3 0 21

1 0 7

1 0 21

1 to 2d o 2 to 3

1 0 7

1 0 21

1 to 2d o 2 to 3

1 0 0

3 to 4 0 0

aRepre~nts the average minimum num~r of r~mme~~ nursing visits per week for drug administration, catheter care, and dressing dlan9e bas~ on

recognized standards of infusion therapy practice and actual practice of current home infusion therapy providers. Nursing visits maybe more frequent toward

beginning of therapy as patient is still becoming familiar with sekare techniques. Number of visits will vary depending on medical condition of patient and

occurrence of infusion therapy-related complications.

b~e~ not indu~ initiai as%=ment ~~ tmining ~sits. ~s not incfu& additional skiii~ nursing ~sits (up to thr~ per week) required for drawing ~OOd

sampies for laboratory monitoring. The minimum of one skiileci nursing visit for ail types of patients and therapies is for ongoing skiiied assessment and

monitoring of patient’s condition.

CDO= not imiu~ Sepamte Suwiies ~iivevv~its. ~s not refl~t r~wtion in nonskilled visits due to performa~e of nonstiiled tasks during skiiied nursing

visits.

dDepends on capacity of pump’s drug resewoir.

SOURCE: Office of Ttinology Assessment, 1992. Based on information from: /nfravenous Nurses Soa.eCy, /ntiavenous Nursing Sfandatds of Practke

(revised 1990), Jourrra/ of Intravenous Nursing Supplement 1990, April 1990; A.L. Piumer and F. Cosentino (eds.), Pnk@/es and Practice ot

Mravenous 7%erqy4fh Edition (New York, NY: Littie, Brown and Company, 1987); Perivascuiar Nurse Consultants, Rockiedge, PA, information

on frequency and cost of infusion therapy nursing visits, provided to OTAJan. 18, 1991; L.C. Hadaway, “An Overview of Vascuiar Access Devices

Inserted vfathe Antecubitai Area,” Journa/of/nfravenous Nursing 13(5):297-306, September/October 1990; information provided to OTAby home

drug infusion therapy providers, manufacturers, and others, 1990-91.

tion between the patient and home infusion therapy

staff (24,364). In certain instances, some of these

features may not be necessary (e.g., some drugs need

no refrigeration). Generally, however, the HDIT

provider must ascertain during initial patient assessment whether the patient’s home is adequately

equipped for the patient’s particular therapy needs

(24).

Other characteristics of the home environment

can also pose problems for HDIT For example,

large pets or small children may tamper with the

drug delivery system (tubing, buttons on a computerized infusion device), potentially interrupting a

dose or causing more serious harm to the patient.

Proximity to Service Provider

Accessibility of needed services, drugs, equipment, and supplies is another important consideration in the patient screening process. In an urban

area, patients may be close enough to an HDIT

provider to obtain emergency drugs, supplies, equipment, or services within a short time. Patients in

areas more remote from the provider, however, may

have to wait longer to obtain the supplies or services

they need.

This problem can be addressed in part by the

decentralized provider model. For example, an

infusion company in an urban location may contract

with a local home health agency to provide skilled

nursing care to a patient in an outlying area. Because

there is no guarantee that the local home health

agency nurses possess the knowledge and skills

required for HDIT maintenance, the infusion company may have to provide special training to these

nurses before releasing a patient to their care. For

patients who are either very ill and require intensive

services or who are in an area where skilled home
Chapter 3-Home Drug Infusion Therapy Equipment and Services ● 61

Box 3-E—Screening Critetia for Home Transfusion Therapy Patients

In order to be accepted for home transfusion therapy, the American Association of Blood Banks (AABB)

recommends that patients meet all of the following criteria:

. They are not ambulatory (mobile patients are more appropriately treated in hospital or outpatient facilities);

 They have a stable cardiorespiratory status (i.e., no recent history of acute angina or congestive heartfailure);

 The patient’s transfusion history has been carefully screened, paying special attention to reactions (if

present) and appropriate chronic diagnoses;

 They did not experience a reaction during the administration of their last transfusion;

● They are cooperative and able to respond to verbal commands;

● They we able to detect and respond appropriately to body symptoms;

. A responsible adult is present during the duration of the transfusion (this does not include the nurse),

presumably to assist in getting emergency services to the patient in the event of a situation that requires the

nurse to give the patient undivided attention;

● A working telephone is available during the transfusion; and

● The patient’s medical condition is suitable for home transfusion. (Diagnoses the AABB considers

potentially appropriate for home transfusion therapy include chronic gastrointestinal bleeding, anemia in the

presence of chronic renal disease, anemia with bone marrow failure, anemia associated with malignancies,

sickle cell anemia, and thalassemia).

SOURCE: American Association of Blood Banks, Improving Trarq%sion Practice: The Role of QuulityAssurance, S. Kurtz, S. Summers, and

M. Km&all (eds.) (Arlingto~ VA: American Association of Blood Banks, 1989).

nursing services are simply not available, HDIT may Home blood transfusion patients also require

not be a reasonable alternative.

Disease- and Therapy-Specific Considerations

Some patients-either due to complications

stemming from their medical condition or other

factors (environmental and social) that can interfere

with the safe and successful administration of

infusion therapy-will require special consideration

and attention by HDIT providers. Acquired immunodeficiency syndrome (AIDS) patients, for example, are highly susceptible to infections, which may

affect decisions regarding their treatment (e.g.,

which kind of catheter to use) (238).16 AIDS patients

on HDIT who have a history of IV drug abuse will

require close monitoring to assure that they are not

using their venous access devices for selfadministration of illicit drugs. Also, patients with

AIDS-related dementia may be unable to understand

or perform self-care functions adequately (238).

Although the patient may be able to perform

self-care initially, he or she is likely to lose that

ability as the dementia progresses. Ongoing nursing

assessment is key in determiningg the specific home

infusion therapy needs of AIDS patients.

special consideration. The American Association of

Blood Banks (AABB) has published specific criteria

that patients should meet before they can receive

in-home transfusion (see box 3-E).

Ongoing HDIT Services

All HDIT involves at some level medical, pharmacy, nursing, laboratory, and coordination services. Although the exact responsibilities of each of

the types of service personnel (e.g., nurses or

pharmacists) varies among infusion providers (see

box 3-C), all of the basic services must be available

for HDIT to take place. The setting in which specific

services are delivered varies depending on both the

provider and the patient (see ch. 4). Some patients

receive all services in their home; others receive

some services in an outpatient center but administer

the drugs themselves at home; still others receive

their infusions in a physician’s office or outpatient

center and have no home care or self-care responsibilities at all. The following describes existing

variation in how certain HDIT services are provided

and by whom. It does not attempt to define optimum

arrangements.

16 Stidies su~est that tunneled central catheters present a lower risk of site infection than surgically implanted ports or Permtieomly ~ert~

eathetem (238).
62. Home Drug Infusion Therapy Under Medicare

Medical Services

All professional services provided to HDIT patients must be overseen by the patient’s physician,

who prescribes the therapy and orders the home care.

The physician has primary responsibility for informing the patient about the anticipated results and

potential complications of therapy, and the physician is consulted in the case of emergency or lesser

complications of therapy. The physician also receives the results of laboratory tests and orders any

necessary changes in the therapy, based on the

results of those tests and on the patient’s visits to the

physician during the course of the therapy.

The extent of physician involvement during the

course of HDIT can range from an arm’s-length role

(e.g., endorsing prescription changes suggested by

the home infusion pharmacist) to a highly interactive

one (e.g., seeing patients several times a week and

initiating any therapy changes). Physician involvement is affected by both clinical and nonclinical

considerations. Some medical conditions routinely

demand frequent physician contact (either over the

telephone or an actual patient encounter), while

others can be followed by a skilled nurse who reports

patient progress and complications back to the

referring physician. Patients in poor physical health

may need to see a physician more frequently than

otherwise healthy patients on HDIT. Some programs

recommend weekly physician visits for patients on

antibiotic therapy, to confirm patient response to

therapy and monitor progress in the resolution of

infection, but this practice is apparently not universal (96,364).

organizational characteristics of an HDIT provider can also influence the frequency of physicianpatient or physician-staff contacts. A center-based

provider, for example, has patients come to an

outpatient center for their supplies, catheter site

changes, physician visits, and other professional

services (15). Other HDIT providers play a less

active role in ensuring patient-physician contact;

many leave the scheduling and frequency of followup visits entirely to the discretion of the referring

physician (203,364).

Patient Training

Patient education is required before a particular

patient begins home therapy. At a minimum, this

service includes a visit to the patient in the hospital

prior to discharge, where the patient’s ability to

perform the needed infusion-related functions are

affirmed (24). In addition, patient education maybe

continued once the patient has returned home.

Patients are instructed in infusion techniques, site

care, the nature and risks of their therapy, drug

storage and stability, equipment maintenance and

use, recognition of signs and symptoms of possible

complications, and recordkeeping (134,209). This

instruction may be performed by one or more of a

number of professionals, including nurses, pharmacists, and medical equipment personnel proficient in

the use of a particular infusion pump. Written

instructional materials should be provided for reference and reinforcement of skills (209,364).

The time required for instruction varies depending

on the level of complication involved in that care and

patient factors (209,364). Sometimes the initial

training visit must be followed up with one or more

additional visits to ensure that the patient is indeed

capable of and comfortable performing the necessary procedures (240,364). All instruction should be

documented in the patient record (209). Many

providers have patients sign forms stating that they

have been instructed in and are capable of performing the requisite self-care (209,364).

Pharmacy Services

At the least, HDIT pharmacy services involve

compounding the drugs to be infused, educating

nurses and patients regarding potential drug interactions and side effects, monitoring the patient’s drug

regimen, and being available to respond to concerns

regarding the therapy. Pharmacist responsibilities

may also extend to participating in patient education

regarding self-care technique; monitoring patients

via conversations with nurses or patients themselves; monitoring laboratory results; collaborating

with physicians in establishing drug regimens and

making prescription changes; and, in some cases,

educating physicians about which therapies are

safest and most effective in the home setting (14,24).

Home infusion pharmacists also monitor patients

during therapy and consult with the referring physician on patient progress (24,364). The degree to

which a pharmacist talks on the telephone or visits

the patient in his or her home varies depending on

the provider.

An infusion pharmacy differs dramatically from

most retail pharmacies. While retail pharmacies

generally dispense only oral medication, infusion

pharmacies must have the equipment necessary to
Chapter 3-Home Drug Infusion Therapy Equipment and Services .63

safely prepare and store parenteral solutions. These

usually include laminar flow hoods to reduce risk of

contamination,17 modified storage areas for certain

drugs, and additional supplies and equipment needed

for mixing solutions (364).

How a parenteral drug is prepared depends on: 1)

the specific drug prescribed, 2) the dosage, and 3) the

type of drug delivery system (149). Preparation can

include mixing or titrating to the proper concentration. Some therapies, such as hydration therapy,

require little preparation because the solutions come

in premixed bags with varying dilutions of dextrose.

Other therapies require more extensive preparation

either in-pharmacy (e.g., an antineoplastic drug must

be prepared in a special vertical flow cabinet) or in

the patient’s home.

Some infusion delivery systems require specialized in-pharmacy computer hardware. One type of

infusion pump sometimes used for multiple drugs,

for example, has a removable microchip that must be

programmed in the pharmacy. Another newly developed pump requires a barcode labeler in the pharmacy (40).

Some pharmacy-based providers delegate drug

compounding tasks to pharmacy technicians who

are supervised by managerial pharmacists (149).

Others use only registered pharmacists for drug

compounding (see below) (3).

Pharmacist Training and Recruitment—

Although some formal training in infusion pharmacy is available, it is not a nationally recognized

specialty .18 The pharmacy profession includes baccalaureate-prepared registered pharmacists (R. Ph.s),

who undergo a 5-year training program, and doctorallevel pharmacists (Pharm.D.s), who complete 6

years of training (385).19 Either one of these degrees

is required for Iicensure in all States (385). Residency training in hospital pharmacy, clinical pharmacy, and a variety of other specialties is also

available (385). A 1989 survey of the 74 schools of

pharmacy in the United States20 found that 42

offered some form of instruction specific to home

infusion therapy (224). Of those 42, only 13 had a

course primarily devoted to home infusion therapy,

and only 2 schools required all their students to take

that course.

Home infusion pharmacists are quite different

from retail (’‘community drug store’ pharmacists,

who usually have comparatively little experience in

infusate compounding techniques or the pharmacokinetic21 aspects of infusion therapy (14). Existing

standards for home infusion therapy providers make

explicit a wide range of proficiencies that a community pharmacist must have in order to be an

accredited infusion therapy provider (see ch. 5)

(179,237). Although most States do not have a

separate license category for infusion pharmacists,

an increasing number of States license and regulate

pharmacies that prepare drugs for infusion (210).

These laws act as a “back door” regulatory mechanism for the practice of home infusion pharmacy by

mandating certain physical plant characteristics and

staff proficiencies.

Thus, although some pharmacists may receive

formal training in home infusion therapy techniques,

the majority of training takes place on the job. Many

HDIT providers rely on hospitals as both recruitment

and training grounds for their pharmacists, requiring

anywhere from 1 to 3 years previous hospital

pharmacy experience (364). Additional training,

both initial and ongoing, is provided to these

pharmacists on the job (364).

Physician acceptance of the pharmacist in an

expanded clinical role varies. Some physicians value

pharmacists’ contributions greatly and rely upon

them extensively for advice in drug therapy decisions, while others consider pharmacists’ involvement an encroachment on physician’s clinical decisionmaking (177,329). Physicians coming out of

training today are more likely than their predecessors to have had interdisciplinary training experiences and hence may be more aware of and

17 Some fiion Pbcies ~ve ~eciauy comtruct~ positive pressure “cleanrooms” for the preparation of parenteral SOlutiOnS. While these do

provide an additional level of protection against contamimm“01.L they are costly to build and are not required in existing infusion pharmacy standards

(178331,237).

18 ~aemecm~y~=mtio~ymcognizedpharmacy specialties: nuclearpharmacy, pharmacotherapy, ~dnutritiotip harmacy. Theknericrm

Society of Hospital Pharmacists is proposing two new specialties, psychopharmacy and oncology pharmacy (14).

19 Bo~ pm- include baccalaureate ~u~tio~

m M 74 schools responded to the survey.

21 ~ or ~-t. cbt~stic ~tmtiom of a ~g ~d tie body in t- of its &soI@o~ &tributio~ me~bofi~ and excretion (393).
64. Home Drug Infusion Therapy Under Medicare

accepting of the capabilities of the clinical pharmacist (177).

Pharmacy Technician Training and Recruitment—Larger infusion providers often employ

pharmacy technicians to assist pharmacists in compounding drugs. Pharmacy technicians are trained

either on the job or in 2-year certificate programs

(14,385). The American Society of Hospital Pharmacists (ASHP) accredits technician training programs in hospitals and community and vocational

colleges (14). In 1988 there were 68 formal training

programs in 19 States, of which 11 were accredited

by ASHP (385).

The degree to which HDIT providers use pharmacy technicians to compound drugs depends on

State practice acts and licensure mechanisms. Four

States (Illinois, Massachusetts, Michigan, and New

Hampshire) offer certification exams for pharmacy

technicians, and three States (Illinois, Nevada, and

Washington) require licensing (385). In some States

(e.g., California and Arizona), pharmacy technicians

in retail pharmacies cannot compound or otherwise

prepare drugs (186). This may explain the fact that,

although pharmacy technicians can be found in

hospitals in all States, 9 States have no pharmacy

technicians in retail pharmacies (385).

Nursing Services

HDIT services that must be provided by a skilled

nurse (usually an RN) include:

●

●

●

●

●

●

patient education regarding administration of

the infusion and care of the infusion site,22

periodic monitoring of the catheter exit site for

signs of infection or other complications,

peripheral catheter site changes,

peripherally inserted central catheter placement,

drawing blood samples for laboratory tests, and

general monitoring of the patient’s health

status.

Many other tasks (e.g., dressing changes, drug

administration, general catheter maintenance) can

be performed by less highly skilled personnel under

the direct or indirect supervision of IV nurse

specialists. These personnel (including licensed

practical nurses, nurse aides, and home health aides)

can play an especially important role for patients

with limited self-care ability. They may also be

involved in ongoing service coordination activities,

acting as liaisons between patients and staff.

The amount and skill level of nursing services

required by an HDIT patient varies dramatically

depending on the route of administration, type of

drug delivery system, type of therapy, and functional

status of the patient (see table 3-3). For example, a

patient with a peripheral catheter who receives

antibiotics 4 times a day will need a skilled nursing

visit every 2 to 3 days for catheter site changes. At

the other extreme, a patient with a totally implanted

catheter may need only weekly visits. Skilled

nursing visits for these latter patients generally

consist of catheter site inspection and other monitoring activities. Patients unable to perform self-care

procedures may need additional paid assistive services on a daily basis if no family caregiver is

available.

Additional skilled visits may be needed for

patients who require frequent laboratory tests (see

ch. 2). Drawing blood, either directly from a vein or

through a catheter, is a skilled procedure that must

be performed by or under the direction of a skilled

nurse or phlebotomist.

Placement of peripheral catheters (including

midline catheters) must be performed by an RN with

training and experience in this procedure (174,291).

The procedure usually takes from 10 to 20 minutes

to perform, although it may take longer if the patient

has poor venous access or other complicating

conditions (291). Peripheral lines and midlines are

usually inserted in the patient’s home (291,364).

Insertion of a PICC line is a more involved and

highly skilled procedure that takes from 1 to 2 hours

to perform (see box 3-F) (291). In order to place a

PICC line, an RN must have special training and

experience (174,291). INS standards require radiographic confirmation of PICC line placement (174),

which is most convenient to perform in a hospital or

outpatient setting where x-ray facilities are available. However, some nurses reportedly perform

PICC line insertions in the patient’s home either

with or without portable x-ray equipment (291). The

ability of RNs to perform PICC line insertion is

limited by availability of training and by State nurse

practice acts (see box 3-F). Although this particular

area of specialty practice has yet to be officially

recognized and is even prohibited in some States,

n Pharmacists may also participate in patient education activities.
Chapter 3-Home Drug Infusion Therapy Equipment and Services .65

Box 3-.F—The Peripherally Inserted Central Catheter (PICC Line):

New Technology and Nursing Practice

The PICC line is an example of how recent technological advances innfusion therapy are shaping new areas

of nursing specialty practice. Insertion of a PICC line is a highly skilled procedure that can be performed only by

a physician or by registered nurse with special training (174,291). The procedure involves:

* measuring the patient to determine the length of catheter required;

* aseptic/ antiseptic preparation of the catheter entry site;

. insertion and threading of the catheter

. radiographic confirmation of catheter placement; and

. suturing and dressing of the exit site (50,291).

Although training in PICC line insertion technique is widely available, the quality of training programs varies

tremendously (291). Some courses are 8 hours long and involve no practice on live subjects. other courses are longer

and require numerous supervised and documented successes on live subjects. Some programs present “certificates”

to participants on completing the course, but them is no officially recognized “certification’ in PICC line insertion

or any other specific nursing skill (e.g., peripheral catheter insertion, catheter repair). To date, no nationally

recognized accrediting bodies accredit PICC line insertion training programs (291).

State nurse practice acts sometimes limit the ability of nurses to perform PICC line insertions, From 60 to 70

percent of States’ nurse practice acts can be interpreted as allowing PICC line insertion by an RN (291). In some

States, however, the wording of the acts suggests that such a skill would not be approved, and in a few States,

language has been adopted that specifically prohibits nurses from performing PICC line insertions (291). As the use

of PICC lines in both home and hospital settings grows, the role of the registered nurse in PICC. line insertion will

likely be increasingly recognized at both the State and national level through standardization of training and further

modification of nurse practice acts.

IAlt.hoUghpraCtiee on live subjects is preferable from a quality of tmining standpoin~ it poses legal risks and has b@m the SUbjCCtof some

controversy among trainers and practitioners (291).

many home infusion providers employ nurses with settings is high (291), home infusion providers have

this skill (364).

Nurse Training and Recruitment—HDIT providers generally look for nurses with extensive

experience in infusion therapy nursing (364). Nurses

with national certification in certain areas of advanced practice (e.g., IV nurses, critical care nurses,

oncology nurses) are more likely to have the skills

and experience needed for home infusion practice,

although certification is not a guarantee of proficiency in particular skills (291,364). The burden is

therefore upon the employer to determine, through

testing, practice, and knowledge of educational and

training background, whether an individual is proficient in those skills. Providers often recruit hospital

nurses who have done infusion therapy in cardiac

care units, critical care units, or emergency rooms.

Although demand for skilled nurses in hospital

been successfull in drawing some nurses out of these

settings because they offer greater autonomy of

practice and, in some cases, more opportunities for

career advancement (364).23 Nurses who specialize

in or are skilled in transfusion therapy are also

increasingly being sought by home infusion providers as the demand for home blood transfusion

expands (box 3-G).

Home infusion companies that provide nursing

services through contractual arrangements often

must take additional steps to ensure that the nurses

are qualified to perform the required services.

Contract nurses in visiting nurses associations and

home health agencies, or nursing personnel in

skilled nursing facilities or other nonhospital institutional settings, may not be familiar with particular

HDIT equipment and techniques. To address this

23 For ~xaple, one home infusion provider has a five-step “career ladder” for its field nurses based on qualitlcatio~ expertise, and specialty

certification (3). Nurses can move up the career ladder by seeking outside continuing professio~ education or wrtificatio~ or by participating in

in-house continuing education and certification pro-. Five factors considered in the career ladder are: 1) antineophtic therapy skills/certMcatiou

2) blood transfusion skills, 3) PICC line insertion skills, 4) catheter repair skiUS, and 5) degr~ of dfilculty of venous across the nurse is capable of

handling (3).
66. Home Drug Infusion Therapy Under Medicare

Box 3-G-Home Blood Transfusion Services: Special Considerations

Home blood transfusion is a relatively new service in the home infusion therapy market, and it involves

intensive, specialized nursing services and careful coordination with suppliers of blood products (e.g., local blood

banks). The great risks associated with blood transfusion therapy demand that home providers develop distinct and

stringent protocols that address the unique aspects of this therapy.

According to the American Association of Blood Banks (AABB), in-home transfusions should be performed

by a registered nurse (RN) with formal training and extensive knowledge and skills relating to IV therapy generally.

During the nurse’s initial visit 24 to 48 hours before the actual transfusion, a blood sample for type and crossmatch

is drawn, carefully labeled, and delivered to the blood bank for compatibility testing. The blood bank must keep

an accurate record of the physician’s orders, informed consent form, laboratory results, nurse’s notes, and a

transfusion flow chart for each patient transfused.

On the day of the transfusion, the crossmatched and inspected units of the relevant blood component are picked

up by the nurse, who reinspects them for gas formation, streaking, and color. The blood is transported in a

quality-controlled insulated cooled container. At the patient’s home, the nurse doublechecks the patient’s

identification and checks each unit to be given for compatibility.

The nurse then reviews the physician’s orders, evaluates the patient’s condition, administers any prescribed

premedications (e.g., antihistamines to avoid mild allergic reactions), and starts the infusion therapy. During the

infusion, the nurse monitors vital signs and other signs of the patient’s reaction every 30 minutes. once the

components have been infused, the nurse discontinues the transfusion, the IV line is kept open, and the nurse remains

with the patient in order to watch for adverse reactions and take the 30-minute posttransfusion vital signs. Before

leaving, the nurse gives the patient and any caregiver present posttransfusion instructions and collects equipment

and contaminated supplies. The nurse returns the day after the transfusion for a followup visit that includes tests

such as hemotocrit, platelet count, and coagulation test. In the event of a medical emergency during the transfusion

procedure, the patient’s residence must be easily accessible. AABB guidelines for procedures in event of a reaction

are as follows:

●

●

●

Mild reaction (e.g., rash or itching): The transfusion is stopped and the physician is notified. Usually

antihistamines are given and, if the reaction ceases, the nurse will continue with the transfusion while

monitoring the patient closely.

Severe reaction (symptoms including rash, increased heart rate, fever, chills): The transfusion is stopped,

the physician is notified, and the nurse administers appropriate medications as ordered by the physician. The

blood units, administration set, a fresh urine specimen (to inspect for free red blood cells), and a blood

sample (to regroup and crosshatch to donor blood, and to perform a Coombs test for hemolytic antibodies)

are sent to the blood bank. The nurse stays with the patient until the patient is stabilized, or makes

arrangements for transportation of the patient to the hospital.

Life-threatening reaction (symptoms include red urine, unexplained bleeding, fever, chills): The transfusion

is stopped and another person present contacts the emergency number while the nurse attempts to stabilize

the patient (performing resuscitation if necessary). The patient is immediately transported to the nearest

hospital.

Under all of the above circumstances, there remaining blood components and administration set are returned to the

blood bank for crossmatching. A transfusion reaction report, completed by the nurse, is also required.

Safe disposal of equipment, such as empty blood bags, IV tubing, blood-soaked gauze, needles, and other

contaminated objects is a major concern. The nurse must collect all such materials in special biohazard containers

and return then-i to the blood bank for proper disposal.

If blood warming in the home is desired either for patient comfort or clinical considerations, only approved

electric blood warmers should be used because overheated blood can lead to hemolysis (rupture of red blood cells)

and protein precipitation.

SOURCES: ArnMWMIAssoci.ationof Blood Banks, Howe Transjhsion Therapy, E.L. Snyder and J.E. Menitove (eds.} @i.ngto% VA: American

Association of BlmdBanks, 1986); American Association of Blood Banks, Improving Transfusion Practice: The Role uf Qwdity

Assurance, S, Kortz, S. S urn.mers, and M Krusl@ (eds.) (Arlingtoa VA: Arn@can Association of Blood Banks, 1989); M. Monks,

“Home Transfusion Therapy,” Journal of Intravenous Nurses 11(6):389-3%, November-December 1988; P.C. Nldler, ‘Wine

Blood C!oq)onent The~y: AII Alternatw“ e,” NllX 9:213-217, May-June 1986.
Chapter 3-Home Drug Infusion Therapy Equipment and Services .67

problem, some HDIT companies have highly specialized nurses on staff who train personnel in

contracting agencies before they are allowed to serve

patients (364).

Delivery Services

In HDIT, all drugs, equipment, and supplies must

reach the patient at home in a timely manner. In

some cases, a pharmacist or nurse may deliver the

supplies directly in the course of a patient visit.

Larger providers may deliver supplies to patients’

homes in a truck or van. Occasionally, patients may

be responsible for collecting their own home supplies (e.g., at each visit to an outpatient clinic).

Most supplies are delivered to patients on a

monthly basis in quantities great enough to allow a

comfortable margin for the accidental contamination

of sterile products by the patient (see box 3-A) and

for accidental loss or damage. Additional supplies

are brought by visiting nurses as needed.

The drugs themselves must sometimes be delivered more frequently, with frequency depending on

the drug prescribed (209). Some require weekly, and

some monthly delivery (149). Some parenteral

solutions can be stored safely at room temperature or

in a refrigerator for days, while others lose their

potency after several hours (364) (ch. 2).

For some highly unstable drugs, delivery to the

home setting may be unsafe or impractical. For

others, increased frequency of delivery from the

pharmacy or patient involvement in drug preparation

can make home infusion feasible. New technological developments can also affect drug storage life in

the home environment. For example, 5-fluorouracil

has been found to remain stable for 16 weeks when

stored at low temperatures in either polyvinyl

chloride drug reservoirs used in electronic infusion

pumps or in elastomeric bladder devices (276).

Laboratory Services

Most HDIT requires some degree of laboratory

monitoring, either to keep track of the level of

infused drugs in a patient’s bloodstream or to

monitor the patient’s bodily reactions to the therapy.

Laboratory results are used by the physician and

pharmacist to monitor the effects of the chosen

therapy and to alter the dosage level or change the

therapy when necessary.

Specimens (e.g., blood samples) are usually taken

by a nurse during a home or outpatient visit and sent

to a laboratory, which reports the results back to the

pharmacist and the physician. The pharmacist and

the physician, and often the attending nurse, then

discuss any changes in therapy that maybe indicated

based on those results. It is generally the nurse who

implements the prescribed therapeutic changes by

reprogr amming the rate of the infusion pump or

instructing the patient in a different dosing schedule.

Although a few HDIT providers operate their own

laboratories, most rely on an outside, independent

laboratory for analyses (364).

Coordination Services

Centralized coordination services are critical to

HDIT, but the extent and type of coordination and

the staff who perform these services vary tremendously among providers. Coordination exists on two

levels. First, the various HDIT-related services

themselves must be coordinated: the appropriate

supplies must reach the patient in a timely manner,

the appropriate nurse must visit the home on the

appropriate day and time, and emergencies, complications, and patient questions must be dealt with.

Second, the infusion services must be coordinated

with other services the patient may be receiving,

such as basic home nursing, physical therapy, or

respiratory therapy. If the patient is receiving

separate care for medical conditions not related to

the infusion therapy, the HDIT provider must

maintain communication with other care providers

to ensure that their efforts are not duplicative or in

any way harmful to the patient.

Coordination services are often performed by a

nurse who acts as case manager (see box 3-C), but

some organizations employ nonnurse personnel to

perform some of the coordination functions (364). In

very small organizations, such as an independent

pharmacy provider, the pharmacist may perform

some coordination functions as well as pharmacy

service (391).
Chapter 4

THE HOME DRUG INFUSION

INDUSTRY
Contents

Page

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................7 1

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

History and Growth of the Home Drug Infusion Marketplace . . . . . . . . . . . . . . . . . . . . . . . . 71

Medicare and the Shape of the Home Infusion Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Home Drug Infusion Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Hospital-Based Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Home Health Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Community Pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Medical Equipment Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Specialty Home Infusion Therapy Providers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Physician-Owned Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Other HDIT Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*. 79

Economic Characteristics of the Home Drug Infusion Marketplace . . . . . . . . . . . . . . . . . . . 79

Market Concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Providers’ Scale and Scope of Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Ease of Entry Into the Market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Alternatives to HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Boxes

Box Page

4-A. Example of a Hospital-Based Provider: Anne Arundel General Hospital

Outpatient Intravenous (IV) Therapy Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

4-B. Home Health Agency-Based Providers: Two Examples . . . . . . . . . . . . . . . . . . . . . . . . . . 75

4-C. Example of a Pharmacy-Based Provider: Vital Care, Inc. . . . . . . . . . . . . . . . . . . . . . . . . 77

4-D. Example of a Medical Equipment Company-Based Provider: Mediq, Inc. . . . . . . . . . 77

4-E. Example of Home Infusion Therapy Specialty Provider: HMSS, Inc. . . . . . . . . . . . . . 78

4-F. Example of a Physician-Based Outpatient Infusion Therapy Provider:

Infections Limited, P.S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

4-G. Specialized Home Infusion Therapy Providers: Cystic Fibrosis Foundation

Home Health Services, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

4-H. Alternatives to Service-Intensive Infusion Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Tables

Table Page

4-1. Medicare-Certified Home Health Agencies (HHAs) by Ownership,

Selected Years, 1974-90 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

4-2. Relative Share in the Home Infusion Market of Eight National Proprietary

Providers, Estimated 1988 and Projected 1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80-
Chapter 4

THE HOME DRUG INFUSION INDUSTRY

Overview

Introduction

The home infusion industryl is evolving rapidly,

and its characteristics will inevitably have an impact

on how Medicare policies regarding home drug

infusion therapy (HDIT) play out. This chapter

describes some of the more important of those

characteristics and their implications.

The chapter first describes the history and growth

of the HDIT marketplace and how past Medicare

policies have helped to shape it. It then describes the

different providers of HDIT and the implications of

some of their similarities and differences. Next, the

chapter discusses the economic characteristics of the

HDIT marketplace: market concentration, ease of

entry of new providers into the market, and the scope

and scale of services of different providers. Finally,

it describes some of the alternatives to HDIT-the

choices available to physicians and patients when

deciding on the mode and setting of therapy.

●

●

Summary of Conclusions

Federal policies have played a significant role

in the development of the home drug infusion

industry thus far. Medicare coverage for home

enteral and total parenteral nutrition (TPN)2

(begun in 1977) and the implementation of

prospective payment for Medicare inpatient

services in 1983 both contributed to the rapid

growth of the home infusion industry during

the 1980s. Broadening Medicare coverage of

home infusion therapies would have a similarly

profound impact on the future shape of the

industry.

The diverse nature of providers that constitute

the current home drug infusion marketplace

present unique challenges for Medicare in

developing possible future coverage, payment,

and quality assurance policies. Although some

providers offer directly the full range of supplies and services needed by HDIT patients,

●

●

many provide one or more aspects of the

therapy by contracting with another entity (e.g.,

a home health agency (HHA), pharmacy, or

medical equipment supplier).

With the exceptions of hospitals and HHAs that

have entered the HDIT business, most providers have limited experience with Medicare

beneficiaries due to the current limited Medicare coverage for this therapy. Medicare beneficiaries, because they are on average less well

and less capable of performing self-care tasks

than younger patients, may require special

consideration and additional supportive services.

Future controls over what companies can

charge Medicare patients for HDIT may slow

the growth of certain sectors of the marketplace. The revenue growth and seemingly

comfortable profit margins that have been

enjoyed by the HDIT industry thus far have

facilitated and encouraged the entry of new

providers into the marketplace, expanding access to home infusion therapy services. The

comfortable profit margins are in part due to the

fact that these companies have often been able

to charge anything short of inpatient charges for

similar therapies and still sell their services to

hospitals, physicians, and patients.

History and Growth of the Home Drug

Infusion Marketplace

The home infusion providers of the 1970s were

largely hospitals providing TPN solutions for patients who were individually treated and whose

supplies came by way of the hospital pharmacy

(288). Technologic advances during the decade were

still diffusing; during the period 1970-78, a registry

of TPN patients documented a total of 469 such

patients discharged home, or an average of only

slightly more than 50 patients a year (308). But in the

late 1970s, two events sparked the changes that

would form the home infusion industry of the 1980s.

1 Most providers in the home infusion industry offer parenteral nutrition as well as drug infusion therapies.

2 In enteral nufritio~ nutrients are delivered direetly into the digestive tract (commonly referred to as “tube feeding”). In total parenteral nutritio~

the digestive tract is circumvented and nutrients me delivered directly into the bloodstream.

-71-
72. Home Drug Infusion Therapy Under Medicare

The first of these events was a decision by

Medicare in 1977 to cover TPN solutions and

supplies for disabled persons receiving the solutions

at home. At the time, the Health Care Financing

Administration (HCFA) did not anticipate home

TPN to be a major expense; it was expected that only

about 10 Medicare-eligible patients per year would

need home coverage and that most of these patients

would not live long (359). On the grounds that TPN

solutions and associated equipment and supplies

were a replacement for the digestive tract, HCFA

declared these components of TPN therapy to be

eligible for reimbursement as a prosthetic device

(45).3

The second event was the startup of a new

company. In 1979, a private firm, Home Health Care

of America, entered the market as a specialist

supplier of home infusion equipment, supplies, and

services (189). In doing so, it established a model for

serving TPN and other patients at home through a

nonhospita1 provider. In addition, its rapid growth—

with stock prices rising from $7.75 per share in 1979

to $30 per share in 1983 (189,288)-drew attention

to home infusion therapy as a potentially profitable

enterprise.

By 1983, the home infusion industry was sufficiently developed to draw the attention of investment analysts. A report by the investment research

firm Hambrecht & Quist separated the market into

three types of players: the large hospital supply

companies, which manufactured and distributed

home infusion solutions and supplies and had an

estimated 24 percent of the market; smaller and more

diverse companies with backgrounds in such areas

as medical equipment and pharmacy services, which

occupied another 22 percent; and hospitals and other

providers, including the large hospital management

companies, which shared the remainder (288).

Therapies included primarily TPN and enteral nutrition, with intravenous (IV) antibiotics and antineoplastics a distant third and fourth (288). That same

year, Medicare instituted prospective payment for

hospital inpatients, drawing attention to the relative

financial benefits of providing nonhospital care.

Between 1983 and 1990 the home infusion

industry exploded, from an infant industry with

estimated revenues of $265 million to a sophisticated and highly competitive market worth nearly $2

billion (288,307). The industry’s high rate of growth

continues to be one of its most prominent characteristics. Total market revenues for home infusion

supplies and services (including TPN and HDIT)

have increased by an estimated 5 to 10 times their

1983 level (34,289,307). Although market analysts

disagree somewhat on the exact total revenue

volume of the market, all agree that growth rates in

the mid-1980s were over 30 percent per year and

were still predicted to be over 25 percent in 1991

(307).

One consequence of this enormous expansion has

been that new players have been able to enter the

market with the expectation of realizing profits

fairly quickly. Many of the marketing efforts of

home infusion providers during the 1980s were

aimed not at drawing patients from competitors but

in enlarging the total demand by convincing physicians to refer their patients to home care (364). As

the industry growth amply demonstrates, this effort

has been successful.

Medicare and the Shape

of the Home Infusion Industry

Despite the lack of a direct benefit for HDIT,

Medicare coverage and payment policies helped

form the fabric from which the home drug infusion

industry is made. Probably the most important

influence Medicare had on the industry was the

decision to cover the products associated with TPN

in the 1970s. Because TPN was covered as a

prosthetic device, and because only supplies and

equipment were covered, supplying TPN and enteral

nutrition products became the province of the

medical equipment and supply industry. Companies

that manufactured the nutritional components (e.g.,

Baxter) also moved into the retail side of the TPN

business, and a few entrepreneurs such as Home

Health Care of America actually created high-tech

home care businesses around the core of TPN, with

its secure reimbursement.

The decision to cover only the products associated

with TPN had a secondary effect: it inhibited HHAs,

which are service- rather than product-oriented,

s Medicare does not ~ver partial parenteral nutritio~i.e., for patients who Mve a wholly or parti~y functioning digestive tract-in the home

setting.
Chapter 4—The Home Drug Infusion Industry .73

from entering the TPN business. Although most

HHAs rely heavily on Medicare business, the

patients they serve are traditionally and by definition

relatively dependent on nursing and assistive services; Medicare patients must be homebound and

require periodic skilled nursing visits to be eligible

for home health benefits (see ch. 6). In contrast, the

lack of Medicare coverage for services associated

with TPN meant that most TPN patients were quite

independent. TPN patients had to be able to selfadminister their solutions unless they were also

homebound and thus eligible for some supplementary home health benefits. Thus, the history of

Medicare reimbursement for infusion therapy (i.e.,

TPN) has resulted in home infusion therapy equipment and supplies, on the one hand, and home

nursing, on the other hand, being entirely distinct

from one another.

As providers of home infusion therapy looked for

new sources of revenue, they began to apply their

expertise in pharmaceutical preparation and equipment/

supply distribution to drug therapies. Private insurers began reimbursing for some of these therapies

when convinced of their ability to avoid hospitalrelated charges by covering self-administered home

therapy. Medicare began covering a few speci.tied

drugs under the durable medical equipment benefit

when those drugs were used in an infusion pump (see

ch. 6), further reinforcing the relationship between

home infusion therapy and the medical supply and

pharmaceutical industries.

With the continually expanding opportunities for

increasing revenue through providing new kinds of

home infusion therapies, the growing industry has

attracted providers from all directions. Hospitals,

physicians, pharmacists, HHAs, dialysis providers,

and a diverse variety of other health care providers

have branched into the home infusion therapy

business. Some provide a number of different

components of HDIT; some provide only one or two

components. Each provider type brings with it its

own particular bias in the organization of therapy,

the kinds of patients it serves, and its relationships

with other providers of the therapy. The following

section describes some of these provider-specific

characteristics.

Home Drug Infusion Providers

HDIT providers vary in three basic ways:

1.

2.

3.

Home-based v. center-based models—Homebased models provide all aspects of therapy in

the patient’s home. Center-based providers

usually train patients for basic self-care (e.g.,

dressing changes), but provide needed skilled

nursing services (e.g., catheter site changes)

and delivery of supplies to the patient in an

outpatient center.

Pharmacy-based v. nursing-based models—

Most home infusion therapy has historically

been pharmacy-based-i.e., the focus has been

on pharmacy-related services, with nursing

services provided or contracted as needed. For

patients capable of full self-care, these have

been only occasional nursing visits. As more

persons with multiple nursing needs (e.g.,

persons with AIDS)4 have been served, as

more complicated therapeutic regimens have

been transferred to the home setting, and as

HHAs have diversified into infusion therapy,

more nursing-based models have arisen. (Examples of the different staffing responsibilities

between the two models can be found in

chapter 3, box 3-B).

Ownership and orientation—The ownership,

parent company, and original mission of the

infusion provider can dramatically affect how

it provides services, what it offers, and who it

serves.

Seven basic types of providers, and their individual

strengths and weaknesses, are described below.

Hospital-Based Providers

The intensive nature of HDIT and the fact that it

is often an extension of, or a replacement for,

hospital care has made the service attractive to many

hospitals. For some, providing home infusion services is simply an extension of the services of a

pre-existing hospital-based HHA; for others, it is an

entirely new venture into home care (see box 4-A).

The total number of hospitals currently providing

HDIT services, either through special outpatient

infusion therapy units or their own HHAs, is

unknown. However, recent survey data suggest that

4 Acquired immunodeficiency syndrome.

297-913 0 - 92 - 6
74 . Home Drug Infusion Therapy Under Medicare

Box 4-A—Example of a Hospital/Based

Provider: Anne Arundel General Hospital

Outpatient Intravenous (IV)

Therapy Services

The Anne Arundel General Outpatient IV Therapy Services Program, started in 1978, is an

outpatient department of Anne Arundel General

Hospital, a 330-bed facility near Annapolis, MD.

The hospital, which previously had been discharging some patients in need of home infusion therapy

to proprietary providers, decided to start its own

program because none of the proprietary providers

offered antibiotic therapy. As of 1990 the program

provided only antibiotic therapy, but it planned to

begin offering IV antineoplastic therapy, pain

management, and total parenteral nutrition.

All patients are referred from the parent hospital.

Most start their infusions as inpatients and receive

their training while still in the hospital The few

who start as outpatients are trained in the outpatient

center. Because the typical course of IV antibiotics

requires infusions two to three times a &y, most

patients administer the drugs themselves at home

and come into the outpatient center several times a

week to see a nurse and clinical pharmacist and at

least once a week to see a physician. During these

visits, patients pick up their drugs and supplies,

receive any required skilled services (e.g., catheter

site changes), and are checked for possible complications of therapy. If a patient is homebound, care

is provided through the hospital’s hospice/home

health department but is still coordinated by the

outpatient IV therapy team. Home health nurses

involved in care of homebound patients are trained

by the center staff. All staff involved in patient care

meet on a weekly basis to review each patient’s

progress.

SOURCE: Anne Arundel General Hospital Outpatient Intravenous Therapy Serviees, Annapolis, MD, site visit by

O’IA Stt%ff, Oct. 25, 1990.

a growing number of hospitals are providing these

services either directly or indirectly. According to

the American Hospital Association, 31 percent of

nonfederal hospitals provided some kind of home

health services in 1988 (10). A 1990 survey of

hospitals with home care programs5 found that 62

percent of these hospitals directly provide home IV

therapy and 23 percent provide home medical

equipment (197). By comparison, a 1982 survey of

243 Medicare-certified hospital-based HHAs6 found

that only 29 percent offered some kind of home IV

therapy (120).

An advantage to hospitals of developing their own

home infusion programs is the ability to keep

patients within the hospital-based system, rather

than losing revenues to other providers once a

patient is discharged. The on-site physician and

pharmacy resources of hospital-based home infusion

programs may also confer some advantages on these

programs. However, HDIT is not simply a transplantation of hospital infusion to a home setting; it

requires additional skills on the part of nurses and

pharmacists, and it often requires much closer

communication between pharmacists and patients

than hospital pharmacists may be accustomed to (see

ch. 3). Additionally, hospital-based programs may

raise concerns about anticompetitive behavior if

hospital patients are routinely referred to the hospital’s own program rather than enabling them to

choose among competing providers in the community. Large hospitals are generally in a better

position to implement a successful HDIT program

because they are more likely than small (e.g., under

200-bed) hospitals to have a sufficient patient base

and the specialized staff needed to support such

services (364).

Home Health Agencies

HHAs view HDIT as an extension of the home

nursing and associated services they provide. HHAs

may opt to become full-service HDIT providers

themselves, either acquiring necessary pharmaceutical expertise in-house or contracting outside for

pharmacy services (see box 4-B). Alternatively, an

HHA may act as a contractor to another provider to

supply only the nursing (or nursing and equipment)

components of a home infusion service. For example, an HDIT provider located in a major city but

with patients in a more distant town might contract

with an HHA in that town to provide nursing and

other infusion-related services to local patients.

Although no hard data are available, the National

Association for Home Care (NAHC) estimates that

at least 75 percent of HHAs nationally are involved

at some level in home infusion therapy. About half

of these act as primary providers, while the remain5 The survey was mailed to 1,983 hospitals with home care programs in May 1990. ‘lhe response rate was 41 percent (197).

h The response rate was 73.7 percent.
Chapter 4—The Home Drug Infusion Industry . 75

Box 4-B—Home Health Agency-Based Providers: Two Examples

Visiting Nurses Association of Los Angeles

In 1986, the Visiting Nurses Association of Los Angeles (VNA-LA), a Medicare-certified home health agency

(HHA), expanded its business to include home infusion therapy by entering into a partnership with an established

pharmacy, which provides clinical pharmacy expertise and parenteral drug compounding services. VNA-LA viewed

home infusion therapy as a potentially profitable enterprise, especially given the high number of AIDS patients they

were already serving at the time.

Since the partnership was formed, VNA-LA has become a key competitor in the Los Angeles home infusion

therapy market, marketing its services to abroad range of providers including physician group practices, hospitals,

and local health maintenance organizations. Unlike some other HHA-based providers, VNA-LA provides directly

the full range of drugs, supplies, and services.

Handmaker Home Health Services, Tucson, AZ

Handmaker Home Health Services, Inc., also a Medicare- certified HHA, is an offshoot of a Jewish geriatric

center. For the last 9 years, Handmaker has provided home infusion therapy services to patients referred from its

geriatric center, from a nearby local hospital, and from local physicians familiar with its services. The majority of

Handmaker’s business is antibiotic therapy, although it has provided antineoplastic therapy and parenteral nutrition

on occasion. All nursing and coordination services are provided by a single staff nurse specialist. Most parenteral

solutions and associated supplies are obtained from a nearby hospital pharmacy whose staff provide 24-hour

pharmacy coverage. Durable medical equipment (e.g., pumps) are obtained through an outside supplier.

Handmaker’s home infusion therapy business is very small---no more than 25 patients at any given time-due

to limited staff and the intensity of services required by most of its patients. Almost all clients are over 65 years of

age, all are confined to their homes, and few of them are capable of self-administering; thus, the nurse must make

a home visit for each drug administration.

SO~CES: L.J. l%y and SF. Grigsby, “Visiting Nurse HOW ~: A suecesti Home l%muwy Venture,” Caring, May 1990, pp.

28-32; site visit by O’lA staff to Handmak or Home Health Services, Inc., fic~ AZ, May 2, 1991. /

der participate as subcontractors to other providers They already have systems in place for providing

for a limited portion of home infusion therapy

services (97).7

Although a growing number of Medicarecertified HHAs are proprietary, most are still nonprofit (e.g., many visiting nurses associations) and

some are associated with government agencies (e.g.,

public health departments) (table 4-1) (372). Consequently, the kinds of patients HHAs see may differ

considerably from those seen by other home infusion

therapy providers. Based on conversations with

providers, it appears that HHA infusion patients are

more likely to have additional disabilities (e.g., be

homebound) and less likely to have private insurance than the infusion patients seen by other

providers (364). Medicare-certified HHAs see Medicare patients, while other HDIT. providers may not.

A strength of HHAs is that, since they provide a

variety of home services in addition to infusion

therapy, they are in a good position to coordinate

services for patients with multiple health problems.

medical equipment, and their experience with treating patients at home may translate into a greater base

of expertise for patient evaluation and monitoring in

the home setting and identification of the kinds of

environmental and emotional barriers that can impede effective home care.

A drawback for HHAs providing HDIT is that

they usually have no in-house pharmacy services,

making the availability of 24-hour communication

with pharmacists familiar with a particular patient’s

condition and treatment of greater challenge and

concern. In addition, some HHAs lack the specialized nursing skills needed to support HDIT services.

A few HHAs do specialize in HDIT and have the full

range of services in-house (347).

Community Pharmacies

HDIT’s attraction for community pharmacies lies

in the ability to extend the scope of pharmacy

services beyond those of the traditional ‘comer drug

7 Based on informal surveys conducted in 1990 by NAHC (97).
76. Home Drug Infusion Therapy Under Medicare

Table 4-l—Medicare-Certified Home Health Agencies (HHAs) by Ownership,

Selected Years, 1974-90

Number of HHAs

Type of HHA 1974 1979 1989 1990

Visiting nurses association . . . . . . . . . . . . . . . .

Combined government and voluntarary . . . . . . .

Official (government) . . . . . . . . . . . . . . . . . . . . .

Rehabilitation facility-based.. . . . . . . . . . . . . .

Hospital-based . . . . . . . . . . . . . . . . . . . . . . . . . .

Skilled nursing facility-based.. . . . . . . . . . . . . .

Proprietary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Private nonprofit . . . . . . . . . . . . . . . . . . . . . . . .

Otherb

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

532

52

1,298

NA

269

NA

NA

NA

178

2.329

528

65

1,298

NA

363

NA

197

461

61

2.973

478

45

974

8

1,466

102

1,870

714

5,721

478

45

952

8

1,508

102

1,918

710

NA

5,721

NOTE: NA - not applicable. See footnote b.

aAvoluntaryorganization (e.g., a~siting nurses association) that receives some operational funding from 90vernment

sources.

bln 1974, ‘Cothef’ ind~es rehabilitation faality and skilled nursing faality-based HHAs, proprietary HHAs, and Private

nonprofit HHAs. In 1979, “other” includes rehabilitation facility and skilled nursing faality-based HHAs. In 1989 and

1990, each type of HHA is counted as a separate category.

SOURCE: U.S. Department of Health and Human Services, Health Care Financing Administration, Bureau of Data

Management and Strategy, Office of Statistics and Data Management, April 1991.

store.” Pharmacists may view the expansion into

home infusion services as not only a new source of

revenue but a way to enhance the pharmacy’s

reputation as a health care provider (364). Some

pharmacies are independent providers of home

infusion therapy; others operate their home infusion

service as a franchise of larger home infusion

company (see box 4-C). Pharmacy-based home

infusion providers may contract with other providers

(e.g., an HHA) for the nursing component of the

service if they do not have skilled nurses in-house.

Alternatively, a community pharmacy may provide

only the drugs and pharmaceutical services under

contract to another home infusion provider.

Community pharmacies, like HHAs, have the

advantage of being familiar, local sources of services. They may be an especially valuable source of

HDIT in small communities with no alternative local

providers, where they often cooperate with local

hospitals or nursing agencies to provide the full

spectrum of necessary services (see box 4-C). They

may also be in a better position than larger providers

to provide continuity of care, since community

pharmacists may have ongoing familiarity with their

patients’ health care needs.

On the other hand, few such pharmacists routinely

employ nurses, and many may not see a sufficient

number of patients to make the startup and ongoing

costs associated with providing high-quality infusion services feasible. Another disadvantage is that

most existing community pharmacists entered practice before most pharmacy schools routinely trained

students in the variety and depth of skills necessary

for home infusion therapy (see ch. 3). Such pharmacists must receive substantial additional training

before they are qualified to provide these services.

Medical Equipment Suppliers

Many hospital-based agencies, HHAs, and community pharmacies that provide home infusion

therapy also provide medical equipment and supplies as part of their broader array of services.

Conversely, companies that specialize in providing

medical equipment and supplies may expand their

services to include home infusion therapy. They do

so either by acquiring nursing and pharmaceutical

expertise in-house or by contracting with other home

infusion providers to supply patients with the drugs

and services necessary for their conditions (see box

4-D).

The role of contractor to provide deliveries

directly to the patient is a natural one for many

equipment suppliers, since it is a relatively minor

extension of services they already provide. Acquiring sufficient in-house expertise to become a fullservice home infusion therapy provider is a much

larger venture; it may require a greater investment in

new areas of expertise for medical equipment

suppliers than for most other providers expanding

into this service area. Some medical equipment

suppliers have entered the home infusion marketplace by offering coordination services.
Chapter 4—The Home Drug Infusion Industry .77

Box 44—Example of a Pharmacy-Based

Provider: Vital Care, Inc.

Vital Care, Inc., based in Livingston, AL, is a

network of parenteral and enteral service suppliers

locally owned and operated by independent community pharmacists. The network began with three

sites in 1986 and by 1990 had grown to 61 sites in

Alabama, Mississippi, Florida, Kentucky, Georgia,

Tennessee, and Louisiana. Each franchise operation

is capable of providing the full range of home

infusion therapies, including enteral and parented

nutrition, antibiotic therapy, antineoplastic therapy,

pain management, and hydration therapy.

Vital Care, Inc. provides franchisees with a

complete initial training program at the franchise

location. It also offers centralized billing and

collection, patient training materials, quality assurance standards, operation protocols and forms,

phone consultation, ongoing training in home

infusion techniques, and technical assistance in a

variety of other areas.

All drugs and supplies required for therapy are

provided in-house. Each site has at least a registered

pharmacist, and some have registered nurses on

staff. Generally, if nursing services are required,

they are provided by local home health nurses under

contract who have been given additional training by

the Vital Care nurse or pharmacist.

SOURCE: J. Hindmaq Director of Marketing, Vital Care, Inc.,

Livingston AL, personal communicdioIL Aug. 30,

1990.

Specialty Home Infusion Therapy Providers

Whatever their origins, a number of organizations

have specialized in home infusion therapy to the

extent that they have become independent full-range

providers of this service. Most of the largest players

in the national marketplace fall more or less into this

category; nearly all are for-profit companies. Some

are subsidiaries of a larger corporation, while others

are smaller companies that specialize primarily or

exclusively in home infusion therapy (see box 4-E).

Some are national companies that operate through

branches in various States and localities, while

others serve a more limited geographic area. The

primary characteristic of all of these HDIT providers

is that they provide most or all of the nursing,

pharmacy, coordination, and equipment-related services themselves. (Laboratory services are still usually performed in outside clinical laboratories.)

Box 4-D—Example of a Medical Equipment

Company-Based Provider: Mediq, Inc.

Mediq is a medical equipment supply company

that branched into the home services market via

respiratory therapy in 1975, providing the equipment and supplies as well as the respiratory

therapist and other consultative services. In 1984

the company branched into infusion therapy on a

similar model. Mediq provides the equipment and

medical supplies, trains health personnel in their

maintenance and use, and coordinates the services

of all entities involved in home infusion therapy. It

contracts with or helps to coordinate the services of

independent and hospital pharmacies for pharmaceutical supplies and services (e.g., require the

pharmacist to be on call 24 hours a day). Local

nurses and patients are trained in home infusion

therapy techniques by Mediq personnel. Mediq’s

own specialty nurses are on call and go to patients’

homes should problems arise.

The company’s goal is to provide continuity of

care to patients by utilizing existing resources in the

community. It believes its model maybe especially

appropriate in smaller communities where it makes

more sense to utilize local providers than to have a

large specialist company.

SOURCE : L.M. Ferry, ~IliVfXSd Management Systems, k.,

NewtorI Squarq Pi% personal communicatio~ Oct.

22, 1990.

The major strength of providers in this category is

their ability to coordinate in-house three central

HDIT services: nursing, pharmacy, and supplies.

Specialization may also enable such providers to

operate at a level of economic efficiency that

providers with smaller caseloads and other functions

cannot match. Potential drawbacks of these providers are that they may not find it efficient to provide

services in areas of sparse population, and since

most such companies are for-profit they may be

more reluctant to provide charity care than smaller

organizations with broader missions and local reputations to maintain. Also, companies that specialize

in home infusion therapy may be poorly positioned

to coordinate the diversity of other home care

services that some patients—for example, homebound elderly patients-need.

Physician-Owned Providers

Some physicians (or groups of physicians) have

started their own home infusion therapy services

outside of the hospital setting. These providers may
78. Home Drug Infusion Therapy Under Medicare

Box 4-E-Example of Home Infusion

Therapy Specialty Provider: HMSS, Inc.

HMSS, Inc. is a specialized home infusion

company with 28 locations in 15 States (as of 1989).

The majority of its business (55 percent) is in

parenteral antibiotic therapy, with the remainder in

total parenteral nutrition (20 percent) and other

therapies (25 percent). HMSS sites typically provide skilled nursing, pharmacy, and medical equipment and supplies in-house, with laboratory and

general home health nursing services provided

under contract. All billing is done through the

HMSS central office in Houton, Texas.

Although only a small proportion (7 percent) of

the company’s total revenues nationally are from

Medicare and Medicaid, individual sites may see a

greater proportion of Medicare patients. Some

HMSS sites have sought Medicare home health

agency certification, while others serve Medicare

home health patients under contract to certified

providers, For example, 30 percent of patients seen

by a Medicare-certified HMSS site in Phoenix, AZ

have Medicare coverage.

Referrals come mostly from national contracts

with national health care or insurance companies

and from local physicians to whom HMSS branches

market their services. HMSS targets its marketing

efforts to surgeons, general and family practitioners, and infectious disease specialists.

SWRCES: i@neHea2thLi#e, VOL XVI, p. 109, Mm. 27, 1991;

HMss, w., I%3m& AZ site visit by OTA staff,

May 3,1991.

specialize in therapies relevant to their area or

speciality practice. For example, an oncologistowned group might provide primarily home antineoplastic therapy and pain management, while a

company owned by infectious disease specialists

provides mostly antibiotic therapy (see box 4-F).

Some groups may specialize in treatment for a

particular condition, such as Lyme disease (see

below). Alternatively, physician-based companies

may provide a wider range of infusion therapies and

market their services to a large number of physicians.

Like other providers, the range of services that

physician-owned companies provide in-house varies. Some may provide only the physician services

directly; others also have in-house pharmacy and

nursing. Physician-owned companies may be either

Box 4-F—Example of a Physician-Based

Outpatient Infusion Therapy Provider:

Infections Limited, P.S.

Started in 1981 as part of a clinical investigation

of the use of the antibiotic ceftiaxone for the

treatment of ostomyelitis, Infections Limited, P.S.,

is now a full-fledged outpatient parenteral antibiotic

program offering a wide range of antibiotic therapies. The program is based in the office of a group

of five infectious disease specialists who employ

five intravenous (IV) therapy nurses, a pharmacist,

a pharmacist technician, microbiologists, and other

support personnel.

Patients are trained either in the hospital or in the

outpatient center by an IV nurse from the center.

They receive all skilled services in the outpatient

center, where they are seen by an IV nurse every 3

to 4 days and by a physician at least weekly. Most

patients self-administer their antibiotics at home,

although a few prefer to come into the outpatient

center to have them administered. Medicare patients are only infused in the outpatient center

because the cost of the drugs is not covered if they

self-administer. The outpatient center is open 7 days

per week and staff are available by phone 24 hours

a day.

Currently, the program serves an average of 30

patients each day. Patients are referred either by one

of the group’s own physicians, all of whom consult

at local hospitals, or by other physicians who are

familiar with the program’s services.

SOURCE: A.I). Tice, “An Office Model of Outpathmt Parmteral Antibiotic Therapy,” Reviews # I#ecfioza

~iseuses 13(Suppl. 2):S184-188, 1991+

office-based, where patients visit the office or center

for most of their HDIT needs; or home-based, where

nurses provide all needed services at the patient’s

home.

Potential advantages to physician-owned and

-operated infusion companies include increased

communication between physicians (both inside and

outside the company) and other health professional

staff, and increased frequency of physician contact

with patients. Physician-owned providers also enjoy

the potential for local market monopolization

through self- and peer-referral networks. Although

these providers might view such monopolization as

an advantage, payers might not (see ch. 7).
Chapter4—The Home Drug Infusion Industry .79 .

Box 4-G-Specialized Home Infusion

Therapy Providers: Cystic Fibrosis

Fondation Home Health Services, Inc.

The Cystic Fibrosis Foundation (CFF) entered

the home infusion therapy business in January 1990

as a nonprofit organization that provides intravenous drugs and supplies to cystic fibrosis patients

on home therapy. CFF seined approximately 300

patients in its first year of operation, averaging

about 20 patients at any one time.

CFF provides pharmacy services in-house and

mails the drugs overnight to its patients. Nursing

services are provided by local nursing agencies

under contract, and physician consultation is available from physician specialists in the national

office. Transportation, which is used for marketing

and for travel to inservice training at local nursing

agencies, accounts for a significant proportion of

the program’s costs. In some large cities where they

expect to have at least some patients, staff do

inservice training prospectively at visiting nurses

associations or other home health agencies (HHAs);

in other cases, they must travel to a previously

unidentified HHA in a new city after a patient has

been identified.

Because cystic fibrosis patients are the only

clients, CFF’s inservice training is more diseasefocused than that provided by other home infusion

companies. Local nurses are trained not only in

infusion technique but also in how to monitor

patients for other potential conditions not immediately related to infusion therapy that might signal

changes in the well-being of patients or in the

course of their disease.

SOURCE: X3. Pax- Vice Pmsideng Cystic Fibrosis RxmdationHmneHealth Services, Rockville, MD, personal

cQImmmi@m‘ m TAX. 4, 1990.

Other HDIT Providers

Although most HDIT providers fall into at least

one of the above categories, other types of organizations may also expand their services to include

HDIT if they see sufficient demand in their service

population. The Cystic Fibrosis Foundation, for

example, in 1990 began providing home infusion

therapy to patients with this disorder across the

country (see box 4-G). The advantage for patients in

this case is the provision of low-cost services that are

coordinated by individuals with in-depth knowledge

about the underlying disorder. Disadvantages are

that the scope of services may be limited and there

may be logistical difficulties in providing services to

patients in distant locations.

One very recent example of a specialized provider

is Women’s Homecare, Inc., a network of physicianowned women’s home obstetrical and gynecological

health care providers (164). This new company is a

joint venture of Tokos Medical Corp., a company

that manufactures home uterine monitoring devices

and operates 70 company-owned home uterine

monitoring locations nationwide, and T2 Medical,

Inc., a national company that owns or manages

approximately 145 physician-based home infusion

therapy providers. Women’s Homecare locations

will combine home uterine monitoring and associated IV therapies to serve high-risk obstetric patients. In the future it may branch out to provide

home IV antibiotic therapies for a wider range of

gynecological indications (164).

Another specialized physician-based provider,

Preferred Physicians Infusion Center, Inc. (PPIC), is

the result of a recent joint venture between the

national home infusion company Preferred Homecare of America, Inc. and a local physician specialty

group in Monmouth County, NJ (162). PPIC, a

clinic-based infusion center, specializes in IV antibiotic therapy for patients with Lyme disease. It was

developed to serve the growing need for such

therapy in Monmouth County, which reportedly has

the Nation’s highest incidence of Lyme disease

(162).

Economic Characteristics of the Home

Drug Infusion Marketplace

Market Concentration

The home infusion market is characterized by a

few large firms that dominate the national market, a

number of midsized companies that individually

have very small national market shares but strong

shares in certain regions of the country, and many

small providers. Table 4-2 presents one estimate of

the relative national market shares of eight of the

largest home infusion providers in 1988. Caremark

had by far the largest share of any single provider in

that year, with other major providers holding shares

ranging from 1 to 6 percent. Between one-third and

two-thirds of the total market, on the other hand, was

in the hands of small providers, most of whom

individually had less than 1 percent of the national

market (289,307).
80. Home Drug Infusion Therapy Under Medicare

Table 4-2—Relative Share in the Home Infusion Market

of Eight National Proprietary Providers, Estimated

1988 and Projected 1991a

Company 1988 1991

Caremark . . . . . . . . . . . . . . . . . . . . . . . . . . .

New England Critical Careb 

. . . . . . . . . . . . .

Home Nutritional Servfces . . . . . . . . . . . . . .

HMSS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

National Medical Carec. . . . . . . . . . . . . . . . .

Care Plusb 

. . . . . . . . . . . . . . . . . . . . . . . . . . .

Continental Affiliates. . . . . . . . . . . . . . . . . . .

T

2 d

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37.3%

4.1

4.0

3.0

2.5

1.9

2.8

2.8

41.9

29.3%

7.1

4.2

4.7

4.2

2.4

2.2

2.7

43.3

aind~es revenues from tOtf31 pfirded WhftiOfI.

b]n Feb~ary ISW, after these projections were made, New England

Cntieal Care merged with Care Plus to form Critical Care of America, Inc.

clnci~ revenue projections for Infusion Care, acquired by National

Medical Care in January 1989.

dw~ on estimat~ revenues of the partnerships it manages.

SOURCE: Prudential-Bache Securities, Inc., New Eng/and Critica/ Care

Company F@oti(New Yo~ NY: Prudential-8ache Seeurfties,

Inc., 1990).

Consolidations among the larger providers and

new entry by small providers have been the rule in

the past few years. Caremark, for example, is the

product of two major acquisitions of other companies during the 1980s by Baxter-Travenol, a major

manufacturer of medical equipment and supplies.

Recently, New England Critical Care purchased

Care Plus, a move which will most likely position it

solidly in second place behind Caremark (161).

At the other end of the spectrum, a growing

number of community pharmacists are expanding

into the home infusion business, as evidenced by the

rapid growth of pharmacy franchise companies.

Vital Care, Inc., for example, expanded its number

of franchise pharmacies from 3 in 1986 to 61 in 1990

(see box 4-C) (158). O.P.T I.O.N. Care, which has

been growing at a rate of 20 or 30 franchises per year

for the last 4 years, currently has 182 franchises

throughout the country (272). The Parenteral and

Alimentation Provider’s Alliance, an association of

independent pharmacies that have cooperative group

purchasing arrangements, increased in size from 3

participating pharmacies in 1987 to 30 in 1990

(109).

As with pharmacies, HHAs view home infusion

as a natural and profitable expansion of their

businesses. For most HHAs, infusion is only a small

part of their total home nursing and supply business,

but where HHAs are large even this small proportion

may amount to a large total number of patients and

a significant source of revenues. For example,

Kimberly Quality Care, a large home health services

provider with 409 branches throughout the country,8

served 2,941 home infusion therapy clients9 in 1990,

but these patients made up only 0.7 percent of its

total national client population for that year (333).

Providing nursing services for home infusion

patients has been a natural extension of the general

home nursing done by HHAs, and most HHAs have

probably now served at least some such patients. A

number of HHAs, however, are establishing teams

of IV nurses and even in-house pharmacies to

become more comprehensive providers of infusion

services, placing them in direct competition with the

home infusion speciality companies (see box 4-B)

(338,347,390). In some cases, high concentrations of

AIDS patients in the HHAs’ vicinities have served

as a catalyst for expansion into full-scope home

infusion therapy services (163,338).

Hospital-based home infusion services are common as well, although there seems to be little

indication that these providers are increasing in

number as fast as other market participants (307,

364).

Although individually each of the many small

home infusion providers represents a negligible

share of the total national market, they can have a

substantial share of the local markets in which they

operate. Hospitals, HHAs, and community pharmacies are often locally well-established and wellknown, and they may be successful in luring many

infusion patients-and the physicians who refer

them-away from the larger national companies.

Some companies have capitalized on this local

advantage. Vital Care and O. P.T.I.O.N. Care, for

example, concentrate on marketing their franchise

operations to community pharmacies in small- to

medium-sized towns, where patients and physicians

often have strong loyalties to the familiar local

pharmacies and where the advantages of the larger,

more centralized national companies are lessened

(158,272).

8 As of January 1990, 170 of these branches offered full-service home infusion therapy services (333).

g Excludes ent~ nutrition patkslts.
Chapter 4—The Home Drug Infusion Industry .81

Providers’ Scale and Scope of Services

Although small providers often have the advantage of local reputation, the large national home

infusion providers have the advantages that accompany economies of scale. Large companies with high

patient volume can afford to invest in specialized

personnel, so that nurses with particular expertise

(e.g., in antineoplastic therapy) can be assigned to

patients with relevant problems. In addition, large

companies can recruit young pharmaceutical and

nursing staff with recent clinical and infusion

experience, eliminating much of the need for reeducation that some retail pharmacists and home

care nurses must undergo before entering the infusion therapy field (364).

The centralized billing capability of many large

providers also has distinct advantages; since home

infusion therapy is still a relatively young field,

many insurers do not have clear rules regarding how

and what to pay for, and those that do differ in their

guidelines and billing requirements (364). Personnel

who can devote their full time to learning the

intricacies of different payers’ policies are probably

much more successful in getting the claims paid.

The advantages that attend some of these economies of scale explain the popularity in the industry

of organizations that fulfill some of these functions.

Pharmacy franchises and purchasing associations in

particular example the match between local businesses and access to central billing, educational, and

marketing expertise.

The home infusion industry may also have some

economies of scope. Few providers offer only home

infusion services. The great majority branched into

home infusion services or products as an extension

of previous business in pharmaceuticals, medical

supplies, home nursing, or other health care services.

For large providers, such as Caremark, the other

business of the parent company-in this case, supply

manufacturing-can provide low-cost inputs into

the infi.mien business, while the experience in home

infusion can in turn provide ready feedback on

technological innovations in supplies. For small

providers, such as HHAs and community pharmacies, the basic business of home nursing, retail

pharmacy, or medical equipment supply also provides the stable source of revenue that could be

endangered by low and volatile patient volume in the

infusion business.

The advantages of providing complementary

services are often great enough to encourage infusiononly providers to branch into related areas. For

example, Abel Health Management Services, Inc., a

privately owned firm in New York, began as a small

home infusion company in 1985. Its separate divisions now include not only a pharmacy and an

infusion nursing service but also a medical equipment supply company, a long-term nursing care

service, and a diagnostic laboratory (3).

Ease of Entry Into the Market

During the 1980s home infusion was a fastgrowing industry, and the prospect of profits has

drawn a multitude of new providers. In hard

immediate dollars, the costs of starting up a home

infusion business have been relatively low for many

small providers; some companies have reported

startup costs of as little as $100,000 (153). Contracting for or cooperatively providing services not

provided in-house (e.g., pharmacy or nursing services) lowers fixed startup costs and is undoubtedly

why such arrangements are common among smaller

providers. (Because of the travel costs associated

with home delivery and nursing, however, even

large companies often contract for some services in

areas distant from their central facilities.)

The greatest startup costs for most new providers

are probably the acquisition of resources (i.e.,

personnel and equipment) and the costs of marketing

the service to get referrals (364). Relevant pharmacy, nursing, and management expertise in home

infusion therapy differs from that in other areas of

health care, and it must be acquired either by hiring

(or consulting with) personnel who already have it or

by spending the money to train those who do not.

Marketing costs can be high, especially if the

groundwork has not been laid by existing home

infusion providers and the new entrant must take on

the task of educating the physicians and hospital

personnel regarding the possibilities and advantages

of home therapy. The importance of expertise and

marketing as components of startup costs mean that

ways to reduce these costs-e. g., through purchasing marketing and expertise through a franchise

arrangement-are a mechanism to ease entry into

the market.

The prospect of profits to be made in the industry

have attracted new entrants despite some of these

startup costs. Because home infusion is still largely
82. Home Drug Infusion Therapy Under Medicare

Box 4-H—Alternatives to Service-Intensive Infusion Therapy

The traditional alternatives to infused drugs are oral drugs, which when appropriate are usually both simpler

and cheaper to administer. When parenteral drugs are preferred, the reason is usually greater drug effectiveness; the

usual reason for prescribing intravenous antibiotics, for example, is that oral antibiotics have proven (or are expected

to be) insufficient to get rid of the infection (see ch. 2).

New, more potent forms of oral drugs, however, can sometimes compete with intravenous (IV) drugs. For

example, oral ciprofloxin, one of the recently developed fluoroquinolone antibiotics, is often effective in treating

osteomyelitis caused by certain ● organisms (126). The drug is, with good reason, regarded by the home infusion

industry as a competitor to IV antibiotics for this use (289).

Changes in equipment technologies have broadened the range of drug infusion alternatives available for some

conditions, HDIT, as described in this report, uses external infusion devices and is often service-intensive. For

antineoplastic therapies, in which total liquid drug volume is small, tiny infusion pumps that are surgically

implanted in the body, and replenished with the drug at the physician’s office, are an alternative to similar drugs

administered by an external infusion pump that the patient must operate.

Other technological advances may result in alternatives to HDIT in the future. Medicated patches that gradually

release a drug absorbed through the skin, for example, could replace other forms of administration for some drugs.

A transdermal patch for an analgesic, fentanyl, was recently introduced in the United States for management of pain

in cancer patients, offering an alternative to IV analgesics for some patients (275). Slow-release implanted drugs

(e.g., the recently approved contraceptive Norplant) could offer another, similar “infusion” alternative to the

service-intensive kind of HDIT described here.

viewed as an alternative to hospital care, and associated revenues—within the hospital’s domain.

because hospital charges are relatively high, home

infusion providers have probably often been able to

charge prices considerably higher than their actual

costs (see ch. 6). Payers have apparently been

relatively insensitive to differences in prices among

home providers as long as these providers can

convince payers that total home charges will be less

than total hospital charges. Lower profit margins, as

payers become more discriminating, may discourage some new entrants.

Alternatives to HDIT

The demand for HDIT and the growth of the

industry depend in part on the existence of alternatives. Some alternatives take the form of new, less

service-intensive ways administering the therapy

(box 4-H). When service-intensive infusion therapy

is necessary, however, there are four basic alternatives to home care as the site of therapy: hospitals,

outpatient clinics, physicians’ offices, and nursing

homes.

At present, the home infusion industry still views

its main “competitors” as hospitals and has devoted

most of its efforts to wooing patients away from

these institutions. One result has been to encourage

some hospitals to enter the home infusion market

themselves in order to keep their patients-and the

Despite this incentive, and despite the relative

advantages of having in-house trained clinical pharmacy and infusion nursing staff, hospitals appear to

be less successful than some other types of providers

in making the transition to providing HDIT unless

they have previous experience with home care (e.g.,

an in-house HHA), or they can successfully combine

HDIT with hospital outpatient-based nursing services (15,177,307).

Other sites of care, however, may develop as

future competitors. Physicians’ unwillingness to

refer patients away may result in increasing amounts

of infusion care being provided in physicians’

offices and outpatient clinics, where concomitant

billable physician visits can also take place (see box

4-F). These sites have the advantage of greater

professional oversight of infusion and lower provider costs associated with travel. Because physicians control referrals, however, these arrangementsand others where physicians are co-owners of the

HDIT providers-can result in market monopoly, as

mentioned above.

In a typical outpatient HDIT setting (either a

hospital outpatient center or a physician’s office),

patients come to the center for the professional

services they require (e.g., peripheral catheter rotation, laboratory work) and perform the remainder of
Chapter4—The Home Drug Infusion Industry .83

tasks (drug administration, catheter flushing) by

themselves at home (15,335) (see box 4-F). An

advantage to this type of arrangement is that

outpatient settings provide greater access to the

professional resources required to address specific

therapy-related problems than in the home setting.

For example, if a nurse in an outpatient center

notices site imitation in a patient, he or she can

immediately involve other health professionals (e.g.,

a physician or clinical pharmacist) in determining an

appropriate course of action to treat the problem and

avoid serious infection.

Another advantage to the outpatient clinic as the

setting for routine professional services for HDIT is

health system cost. For patients who are ambulatory,

who only need to be seen professionally every

several days, and who live reasonably near an

outpatient center, extra professional costs associated

with home visits (transportation, reimbursement for

travel time, additional paperwork, and interprofessional communication) can be avoided.10

Nursing homes may also become more significant

players in providing infusion therapy if cost constraints imposed by health insurers make this setting

relatively attractive. Some health maintenance organizations, for example, refer infusion patients to

nursing homes if they expect the costs in this setting

to be less than home care costs (389).

Some nursing homes may be better equipped to

provide the required services than others. Currently,

nursing home patients who require infusion therapy

usually have to be transferred back to an acute-care

hospital because the nursing facility lacks the

resources to provide skilled infusion therapy services. A 1985 study of one nursing home found that

17 percent of its patients had to be admitted to the

hospital during a l-year period (344). The study

estimated that one-third of these transfers could have

been avoided if the nursing home had had the staff

and other resources required to administer infusion

therapy (344).

Some skilled nursing facilities (SNFs) have responded by implementing infusion therapy training

programs for their staff and establishing special

infusion therapy units to handle the needs of patients

who would otherwise have to be readmitted (62).

Other SNFs purchase the specialized services of

home infusion companies, who send nurses and/or

pharmacists to the facility as much as they would if

it were the patient’s own home (see ch. 4). In some

cases, home infusion companies themselves train

staff at the nursing facility to perform skilled tasks

associated with infusion therapy (364). Home infusion companies may even operate SNFs (158).

10 ~~t ~o~ ~be fo~d in r~~t c-es in Medicare policy regarding mode of service delivery for home dialysis patients. h 1990, H@A

stopped paying for home health aide services for home dialysis patients after Congress agreed that dialysis scxvices were more cost-effective wheu

delivered in an outpatient center (Public Law 101-239).
Chapter 5

QUALITY ASSURANCE IN

HOME DRUG INFUSION THERAPY
Contents

Page

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Quality Issues in HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Patient Screening and Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88’

Patient and Family Caregiver Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Patient Rights and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Clinical Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Staff Qualifcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

The Role of the Physician ● . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Service Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Existing Standards for HDIT Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Standards Issued by National Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Standards Issued by Health Insurers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Developing Quality Indicators for HDIT Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

State Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

The Federal Role in HDIT Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Current Medicare Quality Assurance Efforts Relevant to HDIT . . . . . . . . . . . . . . . . . . . 96

Proposed Requirements Under the MCCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Determining Provider Compliance With Conditions of Participation . . . . . . . . . . . . . . . 101

Case Review: Role of Medicare Peer Review Organizations and Fiscal

Intermediaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Quality Assurance for Beneficiaries Who Receive Care Through Risk-Based

Contracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Boxes

Box Page

5-A. Blue Cross and Blue Shield of the National Capital Area Standards

for Participating Home Care Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

5-B. Quality Assurance in Home Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

5-C. The Medicare Peer Review Organization (PRO) Review Process . . . . . . . . . . . . . . . . 104

5-D. Proposed Scope of PRO Review for Home IV Drug Therapy Services Under

the Medicare Catastrophic Coverage Act of 1988 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Tables

Table Page

5-1. Factors Affecting Compliance in Home Intravenous (IV) Antibiotic Therapy

Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

5-2. Examples of Home Infusion Nurse and Pharmacist Skills . . . . . . . . . . . . . . . . . . . . . . . 91
Chapter 5

QUALITY ASSURANCE IN HOME DRUG INFUSION THERAPY

Overview

Introduction

As described in previous chapters, home drug

infusion therapy (HDIT) is a high-technology,

invasive service that can pose considerable risk to

patients. Complications of therapy are potentially

more serious in the home than in the hospital,

because health personnel are not be immediately

available to recognize and treat them. HDIT is

further complicated in that it requires the coordination of multiple services (medical, pharmacy, nursing, laboratory, and supply) that are often provided

by separate entities. If Medicare were to provide

coverage for HDIT services, it would want to

implement some measures to protect beneficiaries

from inappropriate and substandard care. This chapter examines what measures might be possible.

The chapter first discusses key issues in HDIT

quality assurance at the provider level and reviews

existing standards for HDIT Next, it reviews past

and present Federal quality assurance efforts in

home care generally and in home infusion therapy

specifically. Finally, the chapter examines the potential Federal role in assuring the quality of HDIT

services provided to Medicare beneficiaries.1 In this

last task, the chapter reviews and critiques some of

the requirements that might have been imposed upon

providers in the wake of the Medicare Catastrophic

Coverage Act of 1988 (MCCA)2 (which was repealed before proposed regulations could be made

final). It also examines potential roles for Medicine

peer

●

review organizations (PROS).

Summary of Conclusions

The complicated and invasive nature of HDIT,

the limited knowledge about the safety and

effectiveness of some therapies in the home

setting, and the comparatively frail health

status of some Medicare beneficiaries warrant

rigorous Federal oversight of HDIT quality

assurance at least at the outset of a Medicare

benefit, if not on a continuing basis.

The degree to which Medicare can rely on State

licensure and certification as a means of

assuring HDIT quality is extremely limited.

State regulation of HDIT providers is still

absent in most States and inconsistent among

States where it does exist. Federal policy could

help to focus and standardize State HDIT

regulatory efforts.

The most consistent measures of HDIT provider quality currently available are standards

published by the Joint Commission on the

Accreditation of Healthcare Organizations

(JCAHO) and the National League for Nursing’s Community Health Accreditation Program (NLN/CHAP). However, accreditation

through these channels can be costly to obtain,

and many existing providers have not sought it.

Thus, Medicare should rely on State agencies,

acting under explicit and consistent guidelines,

to determine initial and continuing compliance

with any conditions of participation (COPS)

that Medicare develops. This will undoubtedly

mean that some providers will need to seek

multiple certification (e.g., compliance with

JCAHO standards for private insurer reimbursement, State licensure requirements for

facility operation, and an additional set of

COPS for Medicare reimbursement), which

many will find burdensome. Eventually, JCAHOand NLN/CHAP-accredited HDIT providers

could be granted “deemed status” if accreditation standards were commensurate with Medicare’s COPS.

Individual case review at some level is critical

to assuring safety, appropriateness, and consistency in HDIT PROS could conduct at least

retrospective review of a random sample of

HDIT cases. Prior authorization by PROS for

100 percent of HDIT claims would be administratively costly and may not be necessary. As an

10TA defines “quality of health care” as the evaluation of the performancee of health care providers according to the degree to which the process

of care increases the probability of outcomes desired by patients and reduces the probability of undesired outcomes, given the state of medical knowledge.

Which elements of patient outcomes predominate depends on the patient condition (363).

2 fib~c ~w l(_)&360.

-87-
88. Home Drug Infusion Therapy Under Medicare

●

●

●

●

alternative, prior authorization, performed by

either PROS or fiscal intermediaries (FIs),3

could be reserved for certain therapies or

certain patients who are determined to be at

increased risk.

Physician involvement is key to safe and

effective delivery of HDIT services. To ensure

appropriate physician oversight in the event of

a Medicare benefit, HCFA could develop

specific requirements or incentives and could

charge PROS with reviewing compliance at the

case level.

Although many patient care services may be

performed under contract rather than directly

by an HDIT provider, certain functions should

remain the primary responsibility of the provider. These functions include: initial patient

assessment; quality assurance; maintaining clinical records; periodic drug regimen review;

coordinating all HDIT services; guaranteeing

24-hour a day, 7-day a week availability of

emergency services; and serving as the initial

point of contact for patients in the event of

questions, concerns, requests for supplies, and

any emergencies.

Because many of these functions require the

expertise of a professional nurse well-versed in

HDIT practice, an HDIT provider should employ directly at least one registered nurse (RN)

whose training and prior experience qualify

him or her to assume these responsibilities. In

addition, an HDIT provider should have a

qualified pharmacist either on staff or hired on

a consulting basis.

In the event of an HDIT benefit, Federal

policies could help both patients and providers

protect themselves from adverse outcomes and

potential legal consequences of those outcomes. For example, providers could be required to ensure that patients understood their

responsibilities for HDIT and consented to

them in writing. Providers could also be

required to give patients a single telephone

number they can call in the event of any

complication or emergency and be assured an

immediate personal response.

Quality Issues in HDIT

Only the provider can ensure that good quality

HDIT is provided on a day-to-day basis for each

individual patient. As discussed later, many external

standards are aimed at ensuring that providers have

internal procedures for addressing quality-of-care

issues. This section discusses some of the areas

where provider procedures for quality assurance are

especially critical.

Patient Screening and Assessment

Appropriate patient screening is the first and most

important step in HDIT quality assurance the

provider takes. For Medicare beneficiaries, who are

more likely than other individuals to have fragile

health conditions and limited functional capacity,

careful assessment is crucial. As discussed in

chapter 3, screening requires a thorough assessment

of medical and nonmedical characteristics that

render a patient appropriate or inappropriate for

HDIT. These characteristics include stability of the

patient’s medical condition, willingness of the

patient to undergo home therapy, knowledge and

ability of patient (or caregiver) to perform self-care,

equipment used, type and toxicity of drug, and

environmental characteristics of the home setting

(25).

But a thorough initial assessment also requires

that the provider consider what types of services it is

capable of delivering in a safe and efficient manner.

If a patient requires services that a provider cannot

deliver directly, the provider must either refer the

patient elsewhere or make contractual arrangements

to provide those services. The complicated nature of

HDIT and the variety of factors that can influence

ultimate patient outcome demand that patient screening be a multidisciplinary effort involving physicians, nurses, pharmacists, and other health professionals as necessary (e.g., a social worker) (131,270).

Patient and Family Caregiver4 Training

Home care in general poses challenges for quality

assurance because many patient care factors are not

under the direct control of the provider. Procedures

as critical as catheter flushing and intravenous (IV)

3 M~c~e fiw~ h~mfi= include FM B carriers and Part A intermediaries who contract with the Health tie FtiCiIIS ~“ - tration to

process claims and perform other administrative tasks associated with the Medicare program.

4 “Family caregiver” refers hereto a family memba or friend who assists the patient in self-care responsibilities on an unpaid basis. It does not

include paid caregivers such as home health aides, for whose actions the employing agency is legally responsible.
Chapter 5-Quality Assurance in Home Drug Infusion Therapy .89

drug administration are often performed by the

patient without any supervision. A broad range of

factors can affect the degree to which a patient is able

or willing to comply with self-care instructions

(table 5-l).

Providers exercise control over the quality of

self-care techniques through comprehensive training

of the patient and family caregiver. These techniques

are not trivial to learn. In a recent survey, 92 percent

of primary care physicians felt that patients and

family members could be taught general self-care,

but only 47 percent felt their patients could be taught

the complex level of self-care required for HDIT

(342). Medicare beneficiaries with fictional or

cognitive limitations may find it especially difficult

to perform certain procedures safely (134). In these

cases, additional skilled nursing services may be

necessary to ensure good-quality care (134) (see ch.

3).

Providers can undertake some specific measures

to assure the quality of patient education. These

include:

●

●

●

●

The use of standardized teaching and reference

materials (210,296). Patient instruction manuals should be written on a level that patients can

understand (90,240,296).

Continuity in training with equipment and

supplies. If a patient is trained on one infusion

pump and sent home with another, for example,

he or she might not know how to start or stop

the pump (390).

Continuity among instructors in patient instruction (e.g., dressing changes and aseptic

technique). Teaching different ways of undertaking self-care techniques can cause confusion, leading to poor performance of self-care

tasks (210).

Beginning patient training before hospital

discharge (for patients whose therapy is initiated in the hospital) (240,296,364). Ideally, to

ensure that the patient can transfer what he or

she has learned to the home setting, a nurse or

pharmacist would visit the home to observe that

patient or family caregiver administer the frost

home dose (240,364).

Patient Rights and Responsibilities

Existing standards for HDIT providers all require

that the primary provider assume legal responsibility

for the quality of any services provided to its patients

297-913 0 - 92 - 7

Table 5-l-Factors Affecting Compliance in Home

Intravenous (IV) Antibiotic Therapy Patients

Physiologlcal factors

Age

Physical disabilities

Arthritis

Paralysis

Amputation

Decreased or poor vision

Cast requiring crutches, walker, or wheelchair

Neuromuscular dysfunction, multiple sclerosis, Parkinson’s

disease

Neuropathy secondary to diabetes mellitus

Diagnosis: duration and severity of disease

Dosing frequency and length of therapy

Pain

Lack of fine motor skills

Decreased strength and dexterity

Side effects of medications

Poor venous access requiring central line placement

Psychosocial factors

Education

Lack of care partner

Desire to go home

External locus of control

Socioeconomic status

Home environment

Community resources

Storage/refrigeration space

Fear/isolation

Decreased socialization (especially with multiple IV antibiotics

and frequent dosing)

Cost/Insurance coverage

Sleep deprivation from frequent dosing

Other family responsibilities (e.g., mother with small children, ill

spouse or parent, work, school)

Altered body image due to heparin Iock/central line

Denial of diagnosis requiring IV antibiotic therapy

Inaccessible floor plan in home

Nursing/rnaditxl support

Lack of adequate patient education program

Unclear understanding of rationale of therapy

Inaccessibility to nursing personnel on a 24-hour basis

Poor home followup by home care agency

SOURCE: Adapted from M.S. Neiderpruem, “Factors Affecting Compliance in the Home IV Antibiotic Therapy Client,” Journal of

/intravenous Nursing 12(3):136-142, May/June 1989.

on a contractual basis. They also require that the

provider have written policies describing what

specific services it is capable of providing and under

what types of arrangements it provides them (178,

230,237). Most standards require nurses or other

health personnel to document that patient training in

self-care techniques has been completed satisfactorily (42,178,237).

The nurse’s documentation does not itself constitute a patient’s assertion of shared risk-i.e., that the

patient understands his or her responsibility for

self-care to reduce the risk of adverse health events.

To effect such an assertion, the HDITprovider could
90 ● Home Drug Infusion Therapy Under Medicare

be required to detail in writing those aspects of care

for which the patient is responsible and have the

patient acknowledge that responsibility by reading

and signing an agreement.

Cost to the patient has been cited as a factor that

can affect patient compliance in HDIT (240) (see

table 5-l). To minimize patient concern about

unexpected costs associated with therapy, providers

could be required to inform patients before therapy

starts about which specific items and services are

covered, which are not, and what the patient’s cost

share will be.

Clinical Considerations

One of the greatest risks of infusion therapy is risk

of secondary infection. Strategies for minimizing

this risk in the home include:

careful aseptic preparation of drugs and fluids

to be infused;

using the aseptic technique (see ch. 3, box 3-A)

each time the line is accessed or the catheter

exit site is exposed (e.g., during drug administration, dressing changes, catheter care);

minimizing the number of times the patient’s

catheter, the administration set, or the container

of infusate are exposed or changed (since each

exposure increases the potential for contamination);

periodically replacing devices or parts of the

equipment that are subject to contamination

(e.g., peripheral catheters, administration sets,

falters, injection caps); and

utilizing in-line antimicrobial filters (unless

their use is contraindicated-see ch. 3) to

eliminate possible contaminants from the infusate before it enters the vascular system.

To ensure that all these steps are followed, all

patients, family caregivers, and patient care staff

must be instructed in and be able to demonstrate the

requisite techniques and precautionary measures.

Although patients may be expected to perform

routine tasks associated with their therapy, they

must have access to emergency assistance should

any complications arise. The invasive nature and

potential risks of HDIT demand that emergency

services be available on a 24-hour a day, 7-day a

week basis (174,178,230,240,248). This means that

infusion provider staff (e.g., nurses and pharmacists)

and the patient’s physician must always be within

reach by phone and able, if necessary, to see the

patient personally or deliver emergency supplies

immediately. To avoid patient confusion, providers

may give the patient a single number to call in order

to report any kind of emergency or problem. The

staff person who answers that call can then immediately contact the appropriate staff, contract employees, or, if necessary, the physician, to respond to the

situation.

Staff Qualifications

Regardless of how well organized and coordinated the services of an HDIT provider are, the

quality of patient care will suffer if the individual

staff members who provide those services are not

adequately qualified to do so. HDIT involves a

variety of skilled techniques with which the average

nurse and pharmacist are not likely to be familiar

(see table 5-2).

As discussed in chapter 3, formal training and

certification in certain areas of specialty practice

may be reasonably good indicators of staff capability and experience, but they do not guarantee

proficiency in any given skill area. For example, a

certified advanced practice RN may have difficulty

inserting traditional peripheral catheters, while a

basic RN who has pursued special training may be

proficient in a technique as advanced as PICC

(peripherally inserted central catheter) line placement. State pharmacy regulations in some cases act

as indirect controls over general pharmacist qualifications, but they rarely offer a direct mechanism for

assessing specific proficiencies (63). The burden

therefore falls upon the employer to determine staff

proficiency through employment screens, educational requirements, and on-the-job training in

specific techniques.

In addition to knowing certain requisite techniques, skilled staff must be receptive and adaptive

to the constant stream of new technologies that

quickly become state-of-the-art in HDIT Recent

technological advancements in home care have led

home health agencies HHAs) and other home care

providers to seek more highly skilled staff and to

offer more in-service training in the use of new

techniques and equipment (12,182). A 1987 study of

287 HHAs, for example, found that venipuncture,

physical assessment, patient teaching, and IV therapy management skills were among the most highly

ranked qualifications sought in agency nursing staff
Chapter 5-Quality Assurance in Home Drug Infusion Therapy .91

Table 5-2—Examples of Home Infusion Nurse

and Pharmacist Skillsa

Nurse skills

●

●

●

●

●

●

●

●

●

●

Traditional peripheral catheter insertion

Peripherally inserted central catheter (“PICC line”)

placement

Catheter maintenance and repair

Familiarity with equipment and supplies used in drug

administration

Awareness of potential side effects of specific therapeutic

regimens

Ability to recognize and treat infusion therapy-related

complications

Ability to practice autonomously

Patient training

Ability to communicate effectively with the patient,

pharmacist, and other staff

Ability to assess infusion-associated emergencies and

undertake appropriate steps

Pharmacist skills

● Compounding drugs for infusion

. Thorough knowledge of infusion drug stability and

compatibility

● Thorough knowledge of potential infusion drug side effects

. Knowledge of therapeutic alternatives in the event of

complications

. Familiarity with equipment and supplies used in drug

administration

● Ability to communicate effectively with physicians, nurses,

and other staff

. Ability to communicate effectively with patients directly

. Ability to assess infusion-associated emergencies and

undertake appropriate steps

aSki119 ty@=l& bated with home infusion therapy provision. Not all

home infusion nurses and pharmacists need to be profident in all skills

listed. Larger home infusion providers maydivideresponsibilities between

staff who specialize in one or more skill.

SOURCE: Office of Technology Assessment, 1992.

(182). Similarly, pharmacists must be up to date on

newly emerging home therapies in order to advise

physicians, nurses, and patients of therapeutic risks

and alternatives.

The HDIT provider can help to maintain the

proficiency of its staff by encouraging, mandating,

and even providing ongoing education in new

therapies, technologies, and techniques. The Federal

Government can help ensure staff quality by requiring providers to offeror facilitate staff access to such

training and by requiring that providers evaluate and

document staff proficiency on a regular basis. A

precedent under Medicare is the requirement that

certified HHAs provide in-service education and

competency evaluations for home health aides (SSA

sec. 1891(a)(3)). Regulations issued by HCFA

specify requirements for the curricular content of

home health aide training programs (54 F.R. 155).

The Role of the Physician

The referring physician is the critical gatekeeper

in HDIT. It is the physician who is responsible for

prescribing the therapy, ordering all services provided to a patient, and consulting with HDIT staff in

the event of any complications (121,178,237). The

patient’s physician must also be readily available for

both emergency and routine consultation (e.g., to

discuss lab results or changes to the therapy).

Because the physician bears responsibility for the

plan of care, safe and effective delivery of HDIT

services by the provider depends on the physician’s

understanding of the services and willingness to

participate in care. However, the Office of Technology Assessment’s (OTA’s) discussions with physicians and HDIT providers suggest that physicians

vary in their understanding of HDIT services and

their willingness to play an active role in patient

monitoring. Ideally, physician abilities should include home health care patient assessment skills;

knowledge of home care therapies and technologies;

knowledge of when to recommend specific nonphysician home health services; ability to play an

active and effective role in home health care; and

ability to evaluate the efficacy of home health care

services and contribute to home health care quality

assurance efforts (12).

Legal, financial, and professional concerns can

impede physician involvement in home care (12).

Physicians cite fear of malpractice, lack of compensation, and lack of faith in the quality and supervision of home care personnel as deterrents to referring

their patients to home care (203,342). To date, legal

concerns of physicians regarding home care have

been largely theoretical, since few if any legal

actions have been taken by home patients (12).

Because HDIT services are generally delivered by

licensed nonphysician health professionals who,

along with their employers, assume legal liability for

the care they provide, a physician’s legal risks from

referring a patient to HDIT may be no greater than

those associated with referral to an acute-care

hospital (248). However, the potential for physician

liability-particularly where high-technology home

care is involved-continues to be of concern,

particularly where the physician feels he or she has

little control over the conduct of the patient care

received in the home (12,108,248). In a recent

national survey of 1,100 primary care physicians,
92. Home Drug Infusion Therapy Under Medicare

over 60 percent felt there were significant differences in quality of care offered by different HDIT

providers (342). Sixty-four percent of the physicians

surveyed preferred providers who could offer both

HDIT and general, comprehensive home health care

services (342).

In the event of an HDIT benefit under Medicare,

several strategies would be available to encourage

adequate physician involvement in HDIT. For example:

●

●

●

Regulations could require a minimum frequency of physician-patient and physicianprovider contact. The appropriate frequency

would probably vary depending on the type of

therapy and the patient’s overall medical condition.

Medicare could provide financial reimbursement for the time physicians spend monitoring

their HDIT patients (see ch. 7).

Physicians could be involved in the development and periodic review of providers’ intro-d

quality assurance programs. This activity might

increase physicians’ sense of control over the

quality of home services they prescribe for their

patients.

Service Coordination

The decentralized nature of HDIT services poses

an additional challenge for quality assurance. OTA’s

discussions with HDIT providers and patients strongly

suggest that communication between the patient,

referring physician, all HDIT staff, and any other

parties either directly or indirectly involved in the

patient’s care are key to goodquality care and

favorable outcome of therapy. Communication and

coordination may be of particular concern to providers who subcontract pharmacy or nursing services.

Furthermore, some elderly patients require home

care services beyond those generally required by

younger, healthier patients on HDIT (e.g., home

health aide services) (see ch. 3). Coordinating HDIT

with general home health services (e.g., making sure

home health aide staff are aware of the patient’s

HDIT regimen) can improve quality of care, reduce

confusion for the patient, and cut overall costs of

care by eliminating unnecessary duplication of

services.

Many existing specialized HDIT providers have

limited experience with elderly patients who require

additional home services (see ch. 4). Of the various

types of HDIT providers, Medicare-certified HHAs

are probably the most likely to have had experience

in coordinating these services because they provide

the full range of Medicare-covered home care.

Under anew Medicare benefit, Federal policy could

address these issues by establishing explicit requirements for coordination of services between all

agencies or individuals involved in patient care.

Existing Standards for HDIT Providers

Standards Issued by National Organizations

Standards developed by national organizations

often serve as models for Medicare provider requirements. Existing published standards for HDIT providers or services, which vary in scope and detail,

address areas such as:

● protocols and procedures for patient assessment and care,

● equipment and facility standards,

. staffing requirements and qualifications,

. the physician’s role, and

. internal quality assurance program requirements.

Some of these standards are issued as guidelines

for voluntary accreditation; others, for purposes of

general reference and guidance. The two organizations currently offering accreditation for HDIT

providers are JCAHO and NLN/CHAP (237). Other

organizations that have issued advisory or model

standards applicable to HDIT include the National

Alliance for Infusion Therapy (NAIT)5 (230), the

Intravenous Nurses Society (INS) (174), and the

National Association of Boards of Pharmacy (231).

Most of these standards have been developed during

the past few years and have undergone frequent

revisions.

Although an increasing number of HDIT providers are obtaining accreditation, others have not

pursued it. As of September 1991, JCAHO had

accredited approximately 920 home infusion providers, including freestanding infusion companies,

hospital-based providers, and visiting nurses associations that provide HDIT under contract (33).

NLN/CHAP, which began offering accreditation for

5 Fo~erly he i+lj.i~~ for Medical Nutrition.
Chapter 5-Quaility Assurance in Home Drug Infusion Therapy .93

HDIT in late 1989, had accredited a total of 38

providers as of November 1991 (95).

It is impossible to determine the actual proportion

of existing home infusion providers that are accredited because of differences in the way providers are

counted. Depending on the organization of a multisite provider and the way in which it seeks accreditation, JCAHO and NLN may accredit the parent

organization as a whole or each individual branch or

franchise separately (95). Furthermore, because both

NLN and JCAHO have a 3-year accreditation cycle,

some providers accredited only for noninfusionrelated home health care may have begun to offer

infusion therapy services in the interim. These

providers, although accredited, are not accredited

specifically for HDIT.

Standards Issued by Health Insurers

Some private third-party payers that cover HDIT

services have developed specific standards or guidelines for providers that wish to obtain reimbursement. The purpose of these guidelines is both to

assure quality and to contain costs.

Blue Cross and Blue Shield of the National

Capital Area (BCBS/NCA), for example, has issued

participation guidelines for home health care providers that specifically address HDIT services delivery

(see box 5-A). Although the BCBS/NCA guidelines

do not specify core staffing requirements, they do

require that a single provider assume responsibility

for the provision of all services. They also require

that the primary provider hire, on at least a consulting basis, a licensed pharmacist proficient in infusion therapy practice. Under the guidelines, HDIT

providers must have written policies and procedures

regarding frequency of physician and staff contact,

patient selection criteria, and monitoring requirements for each type of therapy they provide.

Providers who deliver infusion antineoplastic therapy and total parenteral nutrition services must meet

some additional requirements (42).

While many standard-both national standards

and those issued by health insurers-require providers to implement an ongoing internal quality assurance program (178,230,237), few offer specific

guidelines for structuring such a program. BCBS/

NCA is an exception (see box 5-A) (42).

Developing Quality Indicators

for HDIT Providers

Most HDIT providers operating today have some

form of internal quality assurance program, although

the degree of effort varies considerably (364). Most

providers focus on structural and process measures

of quality (see box 5-B). These include such

measures as reading and recording of patient vital

signs during each nursing visit, completion of

required continuing education by provider staff, and

documentation of patient training activities.

Although structure and process measures can

provide a strong quality assurance framework for the

operations of an HDIT provider, specific quality of

care problems may go unnoticed if patient outcome

criteria are not also examined regularly (96). Potential criteria that can be examined in an ongoing

internal quality assurance program are as numerous

as the provider’s list of written protocols for patient

care. If performance of every protocol is documented in the patient records, then those records can

be examined for compliance in every aspect of

patient care. Depending on the number of patients

served by a provider, review can be performed on all

or on a sample of patient records. Specific outcome

criteria that might be helpful to monitor include:

rate of equipment malfunction (103);

rate of nonroutine infusion restarts and reasons

for these restarts (81);

level of patient satisfaction with HDIT services

and specific reasons for dissatisfaction (this

could be accomplished through periodic retrospective patient satisfaction questionnaires)

(219);

specific patient complaints (e.g., request for a

different professional caregiver) (219);

rate of infusion therapy-related complications

(e.g., phlebitis, infection, catheter occlusion, air

embolism, infiltration) (96);

rate of early detection and treatment of drug

side effects (e.g., laboratory testing performed

and results reported according to protocols,

appropriate followup by physicians and nurses)

(96); and

effectiveness of HDIT (therapeutic goals achieved;

no recurrence of condition noted 6 months after

last treatment) (96).

Studying outcomes of HDIT is useful not only for

the identification of noncompliance with specific
94. Home Drug Infusion Therapy Under Medicare

Box 5-A—Blue Cross and Blue Shield of the National Capital Area Standards

for Participating Home Care Providers

Blue Cross and Blue Shield of the National Capital Area has published standards for home infusion providers

who wish to obtain reimbursement from the plan. These standards address areas such as:

. licensure, organization, governance, and management;

 development of written policies and procedures for all treatment modalities;

● monitoring frequency of physician contact;

. professional training and continuing education for nurses and pharmacists;

 coordination of services;

● 24-hour availability of services;

. testing and maintenance of equipment;

* patient assessment and training;

● arrangements for collection, analysis, and reporting of laboratory test results; and

. availability of social work services to patients as needed.

In addition, the standards set the following specifications for an ongoing internal quality assurance program:

1. There is evidence of an ongoing quality assurance program supported by the provider to monitor the quality

and appropriateness of patient care and services provided. The program includes, but is not limited to:

 assessment of the competency of personnel providing services, including the appropriateness of

responsibilities assigned to each individual;

. appropriate execution of physician orders;

* effective emergency response to patient or caregiver problems;

● evaluation of services including review of provider policies and procedures;

* ongoing, concurrent review of any infections, complications, adverse reactions, and therapeutic failures;

* review of the records of maintenance, repairs, and faulty supplies for all equipment;

* evaluation of the effectiveness of the patient and caregiver training and education program; and

● hiring a fully licensed pharmacist as a consultant to the staff of the infusion therapy program to participate

in the development of educational programs, policies and procedures, and ongoing quality assurance

activities.

2. Assessment of documentation within the medical record includes, but is not limited to:

 designation of the attending physician primarily responsible for the patient’s therapy at home;

* initial and ongoing physical and psychosocial assessments;

● evidence that the patient and/or caregiver has completed training;

 presence of a plan of treatment;

 signed and dated progress notes for each home visit and telephone contact noting: treatment administration,

response to therapy, complications or adverse reactions, modification in prescription, patient/caregiver

compliance, condition of infusion site, and catheter site changes.

 appropriate and complete diagnostic and therapeutic orders signed by the attending physician;

● relevant laboratory test determinations and procedure findings;

* pharmacy dispensing record including date and time; solution type, volume, and lot number, medication

additives; and dose and infusion rate;

 documentation of ongoing contact with the attending physician and other agencies/vendors providing

patient services;

● supplies and equipment used; and

 a summary statement at termination of therapy which includes results of therapy, complications, outcomes,

and disposition or status of the patient upon discharge from care.

SOURCE: Blue Cross and Blue Shield of the National Capital ~‘ ‘Guidelines for Participation of Home Care Providers,” Washingtotq DC,

Fdxuary 1989.

protocols, but also for gaining a general base of rational coverage and delivery policies. Some proknowledge about the problems associated with viders have already begun to incorporate specific

HDIT and how to resolve them. As HDIT evolves, outcome measures into their quality assurance

careful documentation of patient problems and programs. NLN/CHAP accreditation surveys for

outcomes will be crucial to the development of home infusion providers also incorporate outcome
Chapter 5—Quality Assurance in Home Drug Infusion Therapy .95

Box 5-B-Quality Assurance in Home Care

Quality assessment is the measurement and evaluation of the quality of health care provided to individuals or

to groups of patients. Quality assurance is the conduct of activities that safeguard or improve the quality of health

care by correcting deficiencies found through quality assessment (363).

Quality assessment involves the application of structural, process, and outcome measures (98). Structural

measures assess whether the availability and organization of resources (e.g., quality of personnel, equipment,

facilities, and coordination of services) are adequate to assure a certain standard of quality. Process measures

examine the amount of careprovided and the performance of health professionals who deliver it by comparing actual

care delivered with accepted standards. Outcome measures assess the relative effectiveness of structure and process

in determining quality of care by looking at specific patient outcomes (e.g., health status, incidence of

complications, satisfaction with care). While structural and process standards can measure the capacity to deliver

quality care, only outcome measures can determine whether providers are in fact meeting that capacity (292,293).

Quality assessment and assurance methods for ambulatory and home care are less developed than those for

inpatient care (48,192,252,253,292,395). Quality assurance efforts in home care to date have focused on structural

and process measures rather than patient outcomes, which are less well-researched and designed. State licensure,

accreditation, and Medicare certification are the three primary quality assurance mechanisms used in home health

care today (292).

However, sophisticated and more narrowly defined home services such as infusion therapy may be conducive

to outcomes assessment in a way that other home health services are not. For example, IV antibiotic therapy outcome

can be measured by resolution of the infection within a given time period and by nonrecurrence of that infection

for a specific time period following completion of therapy. In contrast, “outcomes” of ongoing home health

services for a chronic arthritis patient are less tangible.

Even the most sophisticated and comprehensive quality assurance program cannot guarantee successful patient

outcomes, because factors other than quality of care can affect these outcomes (25,47,293). This maybe particularly

true in the home setting where many of the factors that can affect patient outcomes are beyond the provider’ control

(25). Thus, screening patients for some of these potentially problematic factors (e.g., ability to perform self-care

tasks adequately) becomes key in HDIT quality assurance.

and consumer-oriented measures of quality (237), settings, however, is limited (352). The requireand JCAHO has put together a task force to examine ments set forth by States vary considerably in depth

outcome-oriented quality indicators for HDIT (229). and scope, and some States have no regulations at all

State Regulation for certain types of providers (e.g., HHAs and

hospices) (352). As of March 1991, for example, 11

Medicare sometimes looks to State regulatory States still had no licensure requirements for Medimechanisms as one means of assuring the level and care-certified HHAs, and 20 States had no licenquality of services offered by participating provid- sure requirements for non-Medicare-certified HHAs

ers. Generally, if a State has applicable licensure or (233). 7

certification laws, Medicare requires that a provider— To the extent that HHAs are involved in any whether it be a physician, a hospital, or an HHA-be

licensed or certified according to those laws in order aspect of HDIT, Medicare regulation and existing

State regulation of HHAs could serve as an indirect to qualify for reimbursement from the program

(74). 6 means of assuring the quality of those HDIT

services. At present, however, Federal regulation of

The extent to which State licensure and certifica- Medicare-certified HHAs does not directly address

tion laws can serve as reliable and consistent quality assurance issues unique to HDIT or other

measures of quality for nonhospital health care high-technology home services (352). The extent to

G The same rule was to apply under the proposed regulations for home IV drug therapy providers issued pursuant to the MCCA (54 F.R. 172—see

appendix C).

7 Medicare began covering services provided by HHAs that met its conditions of participation in 1966. Initially, private HHAs were allowed to

participate inthe Medicare program only if they were licensed pursuant to State law (74). In 1981, requirements were relaxed to allow for the participation

of private agencies in States with no licensing mechanism (74).
96. Home Drug Infusion Therapy Under Medicare

which State HHA regulations specifically address

HDIT services is unknown, but since many States

have used Medicare COPS as a model for their own

HHA regulations (232,233,292,352), it may be

presumed that it is very limited. For new services

such as HDIT, it may be years before States develop

specific licensure or certification mechanisms, if

they develop them at all.

Most of the existing State regulations for HDIT

providers have been developed and implemented by

State boards of pharmacy. A May 1989 survey of all

50 State boards of pharmacy found that 15 States had

published some relevant regulations and an additional 18 States were planning to do so (210). The

scope of these regulations varies considerably from

State to State, however. Some apply only to preparation of parenteral drugs, while other States define

and regulate a broader role for pharmacies in HDIT

provision:

● At least two States require separate licensure

for home infusion therapy pharmacy providers

(366). Regulations in Washington State address

the full scope of home infusion therapy services, including nursing, pharmacy, delivery,

coordination, and physician involvement. Washington has even designed and implemented

special training programs for inspectors of

home infusion pharmacies/providers (210). Regulations in New Jersey are more limited in

scope (295).

. An additional 20 States claim to have some

form of home infusion therapy regulations in

place, but OTA found that most of these

regulations address only the preparation and

labeling of parenteral solutions rather than the

broader range of home infusion therapy services (366). Regulations typically address areas

such as physical plant, staffing, procedures,

internal quality assurance, and recordkeeping

(63,366). Most States have specific regulations

for the handling and preparation of cytotoxic

drugs (e.g., antineoplalstic drugs) (63,366).

Regulations vary, however, in their description

of the scope of pharmacist responsibilities for

patient care (63).

● AS many as 28 States claim they do not

currently regulate home infusion pharmacies.

Of these, eight claim that such regulations are

currently under development (210,366). However, some of these States may actually regulate

parenteral drug preparation at a level commensurate with that of States that claimed they do

regulate home infusion pharmacy (366).

The Federal Role in HDIT

Quality Assurance

The high level of coordination and skill involved

in the provision of HDIT services raises concerns

that, under Medicare, all providers might not offer a

consistent acceptable level of quality services.

Under a separate HDIT benefit, Medicare could

exercise control over the quality of HDIT services

by:

1.

2.

3.

4.

establishing COPS for providers, implementing survey and certification procedures to

ensure compliance with those COPS, and

applying penalties for noncompliance;

conducting case-by-case review (both prior

and retrospective), either through FIs or PROS;

developing a list of covered drugs that are

generally safe and appropriate for home delivery; and

creating a system of payment that provides

appropriate incentives for the referral of patients to HDIT and for the participation of

qualified health professionals (nurses, pharmacists, and physicians) in the conduct of that

care.

The following section focuses on the first two

mechanisms. Coverage and payment considerations

are discussed in chapters 6 and 7 of this report,

respectively.

Current Medicare Quality Assurance Efforts

Relevant to HDIT

Under Medicare, all qualifying providers8 must

comply with certain conditions set forth by the

Secretary of the Department of Health and Human

Services in order to obtain reimbursement for their

services (42 CFR 417). These conditions are Medicare’s most systematic method of assuring quality of

care at the provider level.

Existing Medicare coverage for HDIT is limited

and fragmented. The key sources of coverage are the

a ~~hovidms~~ ~der M~~ me defm~ to include the following: hospi~, skilled nursing f-ties, comprehensive Outpatient rehabfitation

facilities, home health agencies, hospices, and providers of outpatient physical therapy or speech pathology services (42 CFR 417,416).
Chapter 5-Quality Assurance Home Drug Infusion Therapy ● 97

Part A home health care benefit and the Part B

durable medical equipment (DME) benefit (see ch.

6). Existing COPS for HHAs are broad and do not

address many of the quality assurance concerns

specific to HDIT. DME suppliers, because they are

suppliers of equipment rather than providers of

services, are not subject to any direct Medicare

quality control measures in spite of the fact that they

are another major source of Medicare-covered

HDIT.9

Under Part A, certified HHAs are required to

comply with specific COPS that include staff qualifications and annual program evaluation by a group

composed of HHA staff and consumers (42 CFR

484). These COPS, discussed in more detail later in

this chapter, are for home health services generally

and do not specifically address HDIT quality concerns. Medicare PRO oversight of home health

services, also discussed later in the chapter, has been

limited and indirect.

Drugs and other fluids administered via an

infusion pump are occasionally covered under the

Part B DME benefit along with the pump (see ch. 6)

(365). Direct Medicare quality assurance efforts are

. virtually nonexistent, however, because DME suppliers who bill Medicare are not subject to any

specific COPS or conditions of coverage (74). They

are required by law to provide instruction in the

operation of DME, but the degree to which they do

so is currently not documented or regulated, and in

some cases it may consist merely of including

written manufacturers’ instructions in an equipment

delivery (156).

The Safe Medical Devices Act of 1990 requires

that device user facilities10 report medical device

malfunction events that contributed to the death or

serious illness or injury of a patient to either the

manufacturer or the Secretary of the Department of

Health and Human Services within 10 days of their

occurrence (Public Law 101-629).11 Such reports

could be useful for identifying and monitoring the

use of potentially harmful HDIT devices (e.g., an

infusion pump prone to malfunction).

Because current Medicare coverage for the components of HDIT is very fragmented, a comprehensive HDIT quality assurance program is not

possible at present. The responsibility for quality

assurance is therefore implicitly relegated to the

prescribing physician, who often has little control

over the services provided to HDIT patients. Some

carriers (the Part B FIs) have been reluctant to cover

drugs under the DME benefit because they perceive

the lack of a defined ‘infusion provider’ ‘—and the

qualifications that such a designation might requireas a quality problem (365). Some carriers go so far

as to require preauthorization of all claims involving

payment for drugs under the DME benefit (365).

Proposed Requirements Under the MCCA

If a Medicare HDIT benefit were created, COPS

would probably need to be established specifically

for providers of this service. Fortunately, HCFA has

already given considerable thought to developing

COPS for HDIT providers, because the nowrepealed MCCA was to have included home IV drug

therapy .12 Proposed regulations issued pursuant to

the MCCA specified detailed COPS for qualified

providers (see app. C). The proposed COPS addressed:

●

●

●

●

●

●

●

●

●

●

●

●

compliance with Federal, State, and local laws,

governing body and administration,

patient selection,

plan of care and physician review,

maintenance and handling of central clinical

records,

core staff and services,

nursing services,

pharmacy services,

patient and family caregiver evaluation and

instructions,

written protocols and policies,

provider quality assurance activities, and

infection control (54 F.R. 172).

g Medicare also covers total parenteral nutritio~ another form of home infusion therapy, under the Part B prosthetic devices benefit (see ch. 6).

Coverage is limited to nutrients, equipmen~ and supplies. Medicare has no structural quality assuran ce requirements for total parented nutrition (TPN)

providers.

10 Devi~userf~ilities ~clude hospi~, ~b~atory ,su@calfacilities, nursing homes, or outpatient treatmentfacilities that arenotphysicians offices

(e.g., HHAs, DME suppliers) (Public Law 101-629).

11 Repo~ ~ovisiom of tie Stie Mdicd Devices Act of 1990 were eff~tive as of NOV. 2% 191.

12 ~ dwelop tie cops, Ha’ sought gui~ce ~m in&@y represen~tives, h~~ pmfessio~s, pmfessio~ ~soc~tions, orgtitions tit

currently aamxlit or publish standards for home IV drug therapy providers, and other knowledgeable parties (54 F.R. 172).
98. Home Drug Infusion Therapy Under Medicare

Although the proposed rules were never made

final, they generated mostly positive comments from

responding organizations (167). The remainder of

this section focuses on specific areas of the proposed

COPS that deserve additional attention if a new

benefit were to be implemented.

Routes of Drug Administration

The MCCA benefit was to cover IV therapy alone.

If Congress were to develop an HDIT benefit that

also covered other routes of administration (e.g.,

subcutaneous, intraspinal), relevant COPS and other

regulations would need to address the attendant

differences in intensity of services, required equipment and supplies, and specific techniques used. For

example, the proposed conditions issued pursuant to

the MCCA required that peripheral catheters be

changed at least every 3 days (54 F.R. 172).

Although existing standards support the 3-day

rotation of peripheral venous catheters, peripheral

arterial catheters are generally changed less frequently, and subcutaneous infusion needles are

changed every 48 hours (see ch. 3) (174).

Patient Care Policies and Physician Review

The proposed regulations specified that it would

be the referring physician’s responsibility to initially

determine whether home IV therapy is appropriate

for the patient and to prescribe the drug regimen for

that patient. In addition, they required the referring

physician to review the plan of care at least every 30

days (54 F.R. 172).

The proposed rules made no specific requirements

for frequency of contact between patient and physician during the course of therapy, however. For a

substantial proportion of HDIT patients, a 30-day

minimum review requirement might mean that their

plan of care would undergo only initial review,

leaving the possibility that some complications or

side effects of therapy would go unnoticed. More

frequent physician contact during therapy may be

especially appropriate for elderly patients with

multiple health problems. Specific requirements for

patient-physician or provider-physician contact could

even be established by type of therapy or type of

condition. For example, some programs recommend

weekly physician visits for patients on antibiotic

therapy (91). In addition, HCFA could require more

frequent comprehensive review of the plan of care

by the referring physician.

Patient Selection

The proposed rule required that a provider screen

each patient before acceptance, and that this screening be performed by a multidisciplinary team of

experts in home IV therapy. Both medical criteria

(e.g., the patient’s clinical status) and nonmedical

criteria (e.g., patient’s ability to undertake self-care)

were to be considered in patient selection (54 F.R.

172).

The proposed conditions did not provide specific

screening criteria to use in determiningg that patients

“have a clinical status that allows IV drugs to be

safely administered at home. ” Although it is ultimately the physician’s responsibility to determine

whether a patient’s medical condition is sufficiently

stable for HDIT, additional requirements might aid

providers or other parties involved in initial determination of appropriateness of HDIT (e.g., PROS or

FIs). As discussed below, the MCCA mandated

PROS to perform prior authorization on all home IV

therapy claims. Presumably, each PRO would develop its own screening criteria to determine safety

and appropriateness. Separate criteria in each PRO

jurisdiction, however, could lead to inconsistency in

coverage and quality of care.

In addition, if a new Medicare benefit were to

cover HDIT for patients not capable of self-care,

more explicit patient selection and provider services

requirements would need to be developed.

Staffing and Services

The Health Care Financing Adminis tration(HCFA)

proposed that home IV therapy providers meet

certain staffing and service requirements. Specifically, the proposed regulations stated that:

. Home IV providers must directly employ at

least one full-time-equivalent (FTE) nurse or

pharmacist.

. The home IV provider must perform the following services directly:

-developing, supervising, and coordinating

all nursing and pharmacy services;

—assuring that only qualified personnel provide home IV services;

-consulting with pharmacists involved in

patient care to coordinate the plan of care

with the physician; and

—performing quality assessment activities including drug regimen review.
Chapter 5-Quality Assurance in Home Drug Infusion Therapy ● 99

There was extensive debate both before and after

publication of the proposed rule regarding core

staffing requirements (167) (52 F.R. 172). The

rationale behind the proposed requirement for either

a full-time nurse or a full-time pharmacist was that

HDIT involves both nursing and pharmacy services,

and that a provider should therefore have at least one

of either of these professionals within its direct

employ. A nurse or a pharmacist alone, however,

would not have been able to provide all of the

proposed core services. For example, a nurse would

not be capable of drug regimen review, and a

pharmacist would not be capable of developing and

supervising nursing services. HCFA had initially

considered requiring that both a nurse and a pharmacist be employed directly, but professional provider

organizations objected on the grounds that this

would disenfranchise many existing providers (e.g.,

HHAs with no in-house pharmacy) (54 F.R. 172)

(167).

A possible solution to this problem would be to

require that providers who have only an RN under

direct employ maintain a consulting contract with a

pharmacist who is experienced in HDIT. This

pharmacist would assist the HDIT provider on an

ongoing basis with development, coordination, and

evaluation of pharmacy services and with periodic

drug regimen review. (This model is similar to that

used by BCBS/NCA (42)).

Nursing Service-The proposed rule required

that all nurses providing home IV services be RNs

who had at least 2 years’ experience in patient

assessment and infusion therapy. Nurses were required to be proficient in all procedures directly

related to IV therapy and the insertion of all types of

needles and catheters commercially available (52

F.R. 172).

The comprehensiveness of these proposed skill

requirements may be unrealistic in the existing

specialized HDIT market. HDIT providers—

especially those with numerous staff-tend to divide

patient care responsibilities among nursing staff

according to individual nurses’ skill levels (see ch.

3, box 3-C). For example, one nurse may specialize

in PICC line placement, performing it on all of the

providers’ patients, while another may be responsible for placement, maintenance, and repair of

standard peripheral catheters. Still other nurses may

specialize in the care of patients with central access

devices.

In addition, although some HDIT-related procedures are skilled procedures that mu@ be performed

by an RN (e.g., venipuncture), other tasks (e.g.,

dressing changes and central catheter care) may be

performed by other staff who have been trained

properly and who work under the supervision of an

RN. Some providers use licensed practical nurses to

perform noninvasive catheter care and drug administration procedures (3).13 Greater flexibility in staff

skill requirements could improve the ability of

providers to recruit qualified staff. For example,

most home infusion provider nursing staff today are

not proficient in inserting PICC lines, a type of

“commercially available” catheter (see ch. 3).

Although the level of proficiency and experience

described in the proposed conditions is not reasonable to require of each individual nurse involved in

HDIT, it is reasonable to require it of at least one

nurse who is employed directly by the provider.

Pharmacy Services-HCFA did not address the

qualifications pharmacists, despite the fact that

home infusion pharmacy requires expertise and

knowledge as specific as that in infusion nursing. In

the future, specific experience in relevant aspects of

HDIT phamacy (e.g., drug compounding, patient

education, drug therapy monitoring, drug regimen

review) could be required of pharmacists whose

responsibilities included such activities.

HCFA’s proposed standards for drug preparation

were also inconsistent in some areas with existing

private standards for home infusion pharmacies. For

example, the proposed regulations would have

allowed either clean work benches or laminar flow

hoods for the preparation of IV drugs (54 F.R. 172).

In contrast, JCAHO, NLN/CHAP, NAIT, and American Society of Hospital Pharmacists (ASHP) standards all require the use of laminar flow hoods to

protect against microbial and particulate contamination (178,199,230,237).

Patient and Family Caregiver

Assessment and Training

Proposed COPs required that an RN perform

patient and family caregiver evaluation and educa13 HCFA*S exp~ence that “none of the entities [it] contict~ allowed anyone but a registered nurse to furnish nursing services connattd with N

drug therapy” (54 F.R. 172) may have been influenced by the fact tba~ at the time the proposed rule was published, it had contacted mostly proprietary

home IV drug therapy providers (167).
100. Home Drug Infusion Therapy Under Medicare

tion. This requirement would have been problematic, for two reasons. First, patient and family

caregiver evaluation is often a multidisciplinary

effort that involves not only the nurse but the

referring physician, pharmacist, and other health

professionals such as a nutritionist or social worker.

Second, some aspects of patient/family caregiver

instruction (e.g., discussion of side effects of therapy, use of infusion devices, self-care techniques)

may sometimes be appropriately given by pharmacists or other types of health personnel, such as

specially trained pharmacy technicians (see box

3-C) (15). Future COPS for HDIT providers could

reflect this practice by allowing a broader range of

health professionals to perform some of these

functions, perhaps under the supervision and coordination of a qualified RN. Also, any future COPs

might want to specifically address patient responsibilities in HDIT.14

Protocols and Policies

First-Dose of Medication—Proposed COPS required that the first dose of any IV therapy be given

under the direct supervision of a physician or nurse

who is equipped with resuscitation medication and

equipment to treat anaphylaxis (54 F.R. 172).

Alternatively, under a new benefit, HCFA might

require that the first dose of infused drugs with a

known potential for allergic reaction or other complications always be delivered under a physician’s

supervision.

The nature of the supervision could vary depending on the setting in which the initial dose is given.

For example, patients who are discharged to HDIT

from the hospital could be required to receive their

first dose in the hospital where physicians are readily

available. For outpatient-initiated therapy, patients

could be required to receive the first dose in a

physician’s office or hospital outpatient setting. For

outpatients who are homebound, special exceptions

could be made or, alternatively, a physician home

visit could be required for the initial dose.

Catheter Care-Catheter care requirements in

the proposed rule were generally consistent with

recognized standards of infusion nursing practice

(174,199,237). In light of the rapid pace of technological innovation and change in HDIT, however,

rigid standards such as those proposed might have

required frequent updating to stay abreast of current

practice. For example:

●

●

The proposed rule required that the sites of all

peripheral catheters be rotated by a nurse at

least every 3 days (54 F.R. 172). Some newer

catheters can remain in place longer than 3 days

(see ch. 3) (364). Alternatively, HCFA could

require that the catheter site be inspected by a

nurse at least every 3 days and changed as

necessary.

The proposed rule required that IV administration sets be changed at least every 24 hours (54

F.R. 172). Although support for this requirement may be found in existing standards or

professional literature, the appropriate frequency of administration set change varies with

the particular therapy and dosing fiquency.

For example, patients on continuous infusion

may only change their administration set every

5 to 7 days, while patients using disposable

infusion devices may change their administration sets up to 4 times a day by default, because

the administration set is integral to the device.

A less rigid requirement for administration set

change could thus be appropriate.

Air-Elimination Filter and Catheter Testing—

As an additional measure of quality control, HCFA

proposed that nurses routinely collect a random

sample of discarded catheters and air-elimination

falters and send them to a laboratory for analysis of

particulate and microbial contamination (54 F.R.

172). Both ASHP and the Association for Practitioners in Infection Control objected to this condition on

the grounds that the catheters and falters could easily

become contaminated between the time they were

removed from the patient and the time they were

examined in the laboratory (1,199). Both these

groups recommended culturing the catheter or filter

only when there were clinical signs of possible

infection (1,199).

Drug Therapy Review—The proposed rule required that the pharmacist review the prescribed

combination of IV drugs and equipment for appropriateness before therapy began. In addition, the

pharmacist was to be required to review the appropriateness of drug therapy at least every 3 days and

M For emple, the patien~f~y c~egivm might be instructed and required to document on a chart each drug and 501Ution admiIIi5t@i0n Or d.b

HDIT-related procedure (e.g., catheter flushing, administration set change, dressing change) and note any attendant difficulties they experienced. These

charts could be incorporated into the central clinical record to complement nurse and physician notes.
Chapter 5—Quality Assurance in Home Drug Infusion Therapy . 101

report significant findings to the physician (54 F.R.

172).

Review every 3 days may not be necessary in all

cases, and it may sometimes be logistically difficult

if the pharmacist must meet with the patient’s nurse

in order to review appropriateness. Some providers

have most staff on site and can hold regular meetings

(e.g., routine drug regimen review once a week)

attended by all members of the provider staff.

Providers who send staff to patients’ homes and/or

subcontract for pharmacy services, however, may

have to resort to other modes of communication

(e.g., telephone, facsimile, extensive patient encounter notes) to accomplish the conferencing necessary

for ongoing drug regimen review. HCFA might

instead require pharmacists to review appropriateness of therapy at least once a week and whenever

requested to do so by patient care staff.

Patient Rights and Responsibilities-The proposed conditions specified that treatment should

begin only if the provider is capable of furnishing

care at the level of intensity required by the patient.

In addition, providers were to inform patients of

their responsibilities and rights in writing upon

initiation of therapy. The proposed rule also required

providers to establish procedures for patient complaints (54 F.R. 172).

Under anew benefit, HCFA might want to further

require that written consent be obtained from

patients before therapy begins. For instance, providers could be required to obtain signed statements

from patients documenting that they fully understand and are able and willing to perform all aspects

of required self-care, that they are aware of the risks

associated with their therapy, and that they understand what their share of costs for the services are

expected to be.

Provider Quality Assurance Activities

The proposed conditions required home IV providers to maintain ongoing, systematic quality

assurance programs to evaluate the quality and

appropriateness of patient care, correct deficiencies,

and improve patient care (54 F.R. 172). A written

evaluation plan was to include scope and objectives

of quality assurance activities, specific activities to

be monitored, methods for evaluation and reporting

of results, mechanisms for corrective action, and

staff responsibilities for each activity. Home IV

providers were to be required to collect and analyze

data at least annuully on the length of therapy by

diagnosis and treatment; patient complications and

rehospitalizations; and the nutritional status of

patients. In addition, providers would have been

required to determine that activities had been carried

out appropriately (e.g., that delivery of drugs and

equipment was timely, that any peripheral catheter

patient had their catheter rotated by a nurse every 3

days, etc.) (54 F.R. 172).

The proposed quality assurance standards lacked

specificity in some areas. For example, they failed to

specify whether the quality assurance activities (e.g.,

collecting data on negative outcomes) should be

applied to all cases or to a sample of cases. Also,

although the proposed COPS required the provider to

specify “staff responsibilities for each activity in the

quality assurance program,” they did not specify

where activities should involve both nursing and

pharmacy Staff.

Nor did the rule specify a role for the patient in the

ongoing quality assurance program. Providers could

have been required to conduct an exit interview with

a sample of patients (or with all patients), for

example, to verify that care documented in the

clinical record was in fact performed.

Determining Provider Compliance With

Conditions of Participation

Activities of State Survey Contractors

To determine compliance with its COPS, HCFA

generally relies on a State agency (usually a department of health or department of aging) with whom

it contracts to conduct periodic surveys of all

facilities in the State (351). State surveyors are given

guidelines and, in some cases, specific assessment

tools, to use in the survey process for each type of

facility.

Because the proposed COPS for home IV therapy

providers were never implemented, mechanisms for

determining provider compliance were never tested.

However, past experiences with HHAs can shed

light on potential problems in determiningg compliance with any future Medicare COPS for HDIT

providers.

In order to qualify for reimbursement through the

Medicare program, HHAs must comply with COPS

that address the following two general areas:
102. Home Drug Infusion Therapy Under Medicare

administration (acceptance of patients, plan of

care, patient rights, medical supervision, disclosure of information, organization and administration of services, policy review), and

furnishing of services (staff qualifications and

training, maintenance of clinical records, program evaluation, survey and certification process) (42 CFR 484).

Compliance for both initial and continuing certification is determined by surveyors15 from a State

agency who make an unannounced visit to the HHA

at least once every 15 months. On each visit, a

‘‘standard survey’ is conducted that assesses compliance with a specified subset of the COPS. The

survey visit can include review of a random sample

of medical records,16 review of written patient care

protocols, verification of staff qualifications and

training, site visits to patients’ homes t. witness

the direct provision of care and interview patients

regarding their satisfaction with the HHA services.

Based on the standard survey, the surveyor makes a

judgment as to whether the HHA seems to be

providing standard or substandard care. If it is

judged substandard, the State conducts an extended

survey that assesses compliance with the exhaustive

list of COPS. If the HHA fails the extended survey,

sanctions can be applied.

The Omnibus Budget Reconciliation Act of 1987

(OBRA-87) 17 mandated that quality of care measures based on patient outcomes be incorporated into

the HHA survey procedure. Measures such as death

or readmission to a hospital or nursing home during

or shortly after termination of treatment are among

those to be used to detect problems (42 CFR 484).

OBRA-87 also mandated that visits to the homes of

HHA patients be included in the survey process to

enable direct observation of care currently being

provided, and to ensure that procedures documented

in the patient record were actually performed (351).

Accordingly, HCFA has published revised COPS for

HHAs (42 CFR 484) and has issued instructions to

State survey agencies on how to conduct outcomesoriented surveys (370).

Because the outcomes-oriented survey and certification mandates did not go into effect until March

1991 (132), it is too early to know whether they are

in fact improving the quality of HHA care. However,

a 1989 study by the U.S. General Accounting Oftlce

(GAO) found numerous problems with the conduct

of HHA surveys by State agencies prior to implementation of the new provisions. These included:

inadequate guidance and oversight by HCFA

on conduct of surveys;

inconsistent interpretation by State surveyors

of requirements for compliance with Medicare

COPS;

inconsistency in scope of surveys and methods

used to select samples of records for review;

lack of coordination between State survey

agencies, FIs, and Medicare PROS;

18 and

lack of personnel training standards for hightechnology services such as infusion therapy

(351).

Although some of these problems have been addressed in the new instructions issued by HCFA

(132), it remains to be seen whether they will be

resolved.

If future HDIT coverage under Medicare entails a

new class of certified providers, similar problems

could arise. Problems might be avoided by improving the clarity of the conditions themselves, offering

more thorough and consistent guidance to the State

agencies that conduct the surveys, and mandating

and facilitating cooperation between all organizations involved in HDIT quality of care review (e.g.,

PROS, FIs, and relevant State licensing agencies)

(351).

Reliance on Standards Issued by National

Accrediting Bodies

Section 1865 [a] of the Social Security Act permits

HCFA to grant “deemed status’ ’-i.e., to consider

certain health facilities as meeting any or all of

Medicare’s COPS for that type of facility-to

facilities accredited by a national accreditation

program (SSA, sees. 1864, 1865[a]). Deeming

authority is monitored through a validation review

process in which a small sample (5 percent) of

providers are surveyed directly by HCFA to test how

15 ~~eyors are always registered n~es.

16 smle She dewnds on he s~e of tie agency ~k defm~ u a f~ed n~ber of r~ords mtier - a percentage (132).

17 Public Law 100-203.

16 pROs me r~~ by law to coordinate their efforts with other levix bodies.
Chapter 5—Quality Assurance in Home Drug Infusion Therapy . 103

well the accrediting organization’s standards continue to reflect Medicare’s COPS (55 F.R. 51434).

Until last year, HCFA had extended deemed

status only to hospitals accredited by JCAHO

(127).19 In October 1991, HCFA granted deemed

status to HHAs accredited by NLN/CHAP. JCAHO

has also applied to HCFA for recognition as a

deeming authority for HHAs, but authority has not

yet been granted.

It is unlikely that Medicare could initially rely on

“deeming authority” as a mechanism for certification of HDIT providers due to inherent limitations of

the standards themselves and the accreditation

processes. First, accreditation surveys performed by

national organizations may not be as good a measure

of compliance with COPS as surveys by State

agencies, because they tend to be conducted less

frequently and are generally scheduled in advance,

giving providers the forewarning they need to get

“Up to speed.” To date, JCAHO has conducted full

surveys once every 3 years and has given providers

a minimum of 4 weeks’ formal notice (179).20

NLN/CHAP also operates on a 3-year accreditation

cycle, but it conducts abbreviated annual surveys in

interim years and all of its site visits are unannounced (237).

Also, the cost of obtaining accreditation through

JCAHO or NLN/CHAP may deter some smaller

providers from seeking it. JCAHO’s average fee for

a single-site HDIT provider is approximately $4,800

for the full three-year accreditation period (33). The

1992 NLN/CHAP fee for a medium-sized single-site

provider whose net revenue was under $1 million

would be roughly $13,000 over a 3-year period

(95).21

Case Review; Role Of Medicare Peer Review

Organizations and Fiscal Intermediaries

While Medicare relies on State and national

survey and certification processes to determine

compliance with specific COPs, it generally relies

on PROS to assess the quality and appropriateness of

care at the individual case level. Mandated under the

Tax Equity and Fiscal Responsibility Act of 1982

(Public Law 97-248), PROS have the authority to

deny Medicare payment for inappropriate or unnecessary services and to discipline and/or sanction

providers and practitioners to correct any unacceptable medical practices (363).

Because HDIT is a complicated service to deliver,

and an HDIT benefit might be prone to overutilization if Medicare did not cover other outpatient

prescription drugs (see ch. 6), some level of PRO

review of claims would be warranted. A minimal

level of PRO review would be retrospective review

of a random sample of claims within each PRO

jurisdiction. (Even this form of review is currently

not required for Medicare home health services

claims.) The most rigorous level of review, which

was to be required under the MCCA benefit until

1993, would be prior review and authorization of all

HDIT claims.

Current PRO Activities

To date, PROS have been involved primarily in

review of claims for hospital and physician services.

Due to the large volume of Medicare claims, review

is usually conducted retrospectively on a random

sample of claims. However, prior review is currently

required for a few select procedures. (See box 5-C

for a description of PRO prior and retrospective

review processes.) PROS also review cases where

quality of care has been brought into question, but

this mechanism is limited by the ability and willingness of beneficiaries, providers, and health professionals to recognize and report suspected deficiencies or problems.

Because the initial PRO claims review is usually

performed by individuals (usually nurses) who are

not experts in the particular type of care provided, a

key element to the prior review process is explicit

review criteria for the service in question (183). At

present, Medicare instructs each PRO to develop its

own criteria for care, diagnosis, and treatment based

19 Unti 19s4, ~owmcefor “deemed status” was limited to hospitals, skilled nursing facilities, and HHAs. Legislation in 1984 @blic hw 98-369)

expanded the allowance to include rural health clinics; psychiatric hospitals; ambulatory surgical ~ters; clinical laboratories; hospices; comprehensive

outpatient rehabilitation facilities; and clinic, rehabilitation agency, or public health agency providers of occupational therapy, speech pathology, or

physical therapy services. This expanded authority has not been us~ in part due to lack of relevant national accrediting bodies (127).

m J~O has a&eed to perfOrXII -qunannounced surveys as required under OBRA-87 if granted deeming authority by HCFA for HHA

certification (287).

21~1~f= ~o~~cludes ~~fees ~~~ on net revenue wording to a sfi~fee s~e), cost of the initial visit (2 Stdf On-Site fOr 3

days), plus the cost of two additional survey visits (appro ximately half the cost of the initial visit) (95).
104. Home Drug Infusion Therapy Under Medicare

Box 5-C-The Medicare Peer Review Organization (PRO) Review Process

Prior Review

The physician or provider contacts the appropriate PRO for preauthorization, furnishing the plan of care and

any additional documentation required for the review process (183). The first level of review, generally conducted

by nurses, involves the application of explicit review criteria that have been developed by the PRO for the particular

procedure or service. If the request for authorization fails to meet the initial explicit review criteria, it is referred

to a physician reviewer who subjects it to implicit criteria based on his or her own clinical judgment and on

professionally recognized standards of care. During this second level of review, the physician reviewer may request

additional information from the referring physician. If the request fails second level review (after affording the

physician and/or provider an opportunity to discuss the case), authorization is denied (183).

Retrospective Review

Each record identified for retrospective review undergoes five different basic reviews: generic quality screen,

admission, discharge, invasive procedure and items/services coverage, and DRG (diagnosis-related group)

validation. First-1evel reviewers (usually nurses) use explicit criteria to determine potential quality-related or

utilization problems, If initial review uncovers a potential problem the records are referred to a PRO physician

adviser for further review (105). Potential quality problems not detected by one of the five reviews (e.g.,

mismanagement of the case) maybe discovered by the initial nurse reviewer based on his or her medical judgement.

In this case, the medical record would also be refereed to a physician adviser. If the initial reviewer can determine

that a case failing one of the generic quality screens is not actually a quality problem, the case is not referred to a

physician adviser (357).

A physician reviewer conducts a more in-depth examination of the medical record, based on his or her clinical

judgment, to determine whether there actually is a problem. The review process also allows the attending physician

and hospital an opportunity to discuss the specifics of the case in question. These discussions often reveal unique

characteristics of the case that explain why it may have failed the initial screens. Most cases of potential problems

are resolved this way (92).

If the physician reviewer determines after the discussions that the care provided was not medically necessary

or that it should have been provided in another setting, a payment denial notice is sent by the PRC) tn the beneficiary,

physician, provider, and fiscal intermediary. If the physician reviewer identifies a quality of care problem that is

not cleared up after discussing the case with the patient’s physician, the PRO will initiate appropriate interventions.

These interventions may include physician education through a continuing medical education program, a corrective

action plan, intensified review of the physician and hospital, or the initiation of a sanction review (357).

on typical patterns of practice within its geographic denials, mortality, and confirmed quality problems.

area or, where appropriate, on national criteria (374).

The retrospective review process uses separate

quality screens that focus on potential problem areas

and the overall appropriateness of care provided.

The quality screens used to review the intervening

HHA care received by readmitted hospital patients,

for example, address such issues as the adequacy of

patient screening and education, the provider’s

response to any changes in the patient’s health

condition, whether any deaths occurred within 48

hours of transfer to the hospital, and documentation

of the plan for appropriate followup care (375).

Based on the information collected in medical

record reviews, PROS produce physician and hospital “profiles” containing information on claims

The profiles are used to identify patterns of care that

deviate from the norm for particular types of

providers or deviate from established criteria and

standards (350). The identification of an aberrant

pattern of care may trigger a PRO’s evaluation of a

larger sampling of records from the physician or

hospital in question. If PROS were to be involved in

reviewing HDIT claims, the development and use of

such profiles for HDIT providers might be an

additional mechanism for safeguarding the quality

and appropriateness of HDIT services.

At present, PROS’ only involvement in quality

assurance for home health is through hospital

readmission review and beneficiary complaints

(Public Law 99-509).22 The PRO takes a 25 percent

~ They do not review intervening care rendered inaphysician ofllce setting, emergency room, or any other sett@, alt.houghemergency mom set-s

are proposed to be included as an intervening care review setting in the fourth contract cycle for PROS (53).
Chapter 5—Quality Assurance in Home Drug Infusion Therapy ● 105

sample of all hospital readmission for a given year.

From that sample, it reviews 20 percent of those

readmission that received intervening care in a

hospital outpatient clinic, HHA, or skilled nursing

facility, obtaining relevant clinical records from the

intervening care setting to determine whether the

care provided was adequate and appropriate (53).

The sampling method and small sampling size,

however, limit the usefulness of these data in

assessing quality at the individual provider level.

Even the Keystone PRO in Pennsylvania, which was

the first to review intervening care claims and has

had the most experience with the process, had

reviewed an average of only one patient per HHA

per year in the State as of 1990 (53).

PROS also review HHA claims involving beneficiary complaints, but the flow of complaints to date

has been highly inconsistent among States (53). This

may be due to lack of beneficiary awareness of the

availability of the PRO to investigate such complaints (44). Confidentiality provisions that prevent

the PRO from informing the beneficiary of the

results of such an investigation may also serve as a

disincentive for beneficiaries to lodge formal complaints (53).

Proposed PRO Activities Under the MCCA Benefit

The MCCA called for extensive PRO involvement in oversight of home IV drug therapy services

to ensure that care was being provided safely to an

appropriate set of patients. Regulations and instructions issued pursuant to the MCCA articulated six

areas of direct PRO involvement (54 F.R. 173).

Prior authorization:

1.

2.

3.

Prior review of 100 percent of home IV therapy

claims until 1993.23 PROS were to complete

review prior to initiation of services for

inpatient starts, and within 1 working day of

service initiation for outpatient starts.

Review of all requests for continuation of

home IV therapy beyond the date or number of

days specifed in the original request. These

reviews were to be completed within 3 working days of the original termination date.

Review of all requests for changes of home IV

drug therapy during the specified course of

treatment, to be completed within 1 working

day of the prescribed therapy change.

Retrospective review:

4.

5.

6.

Postpayment review of a random 5 percent

sample of all paid home IV therapy claims to

determine provider and physician compliance

with professionally recognized standards of

care.

Periodic validation reviews of a random sample of claims in which initial approval was

granted after the PRO had reviewed medical

information via telephone but had not reviewed actual medical records, to validate the

accuracy of information given verbally.

Prepayment review of any cases where PRO

initial authorization was required but had not

been completed.

Universal prior authorization for HDIT may not

be necessary. The rationale for this requirement

under the MCCA was to ensure safety and appropriateness of a relatively new and complicated mode of

service delivery through a front-end mechanism.

However, as the range of therapies that can be safely

and effectively provided in the home setting expands

and the volume of claims increases, it may no longer

be practical for PROS to perform prior authorization

on all claims. Furthermore, some therapies (e.g.,

certain antibiotic therapies) pose relatively little

serious risk to patients. Claims for these might be

handled through retrospective review unless HCFA

felt there were a potential for mis- or overutilization

of home IV antibiotic therapy (e.g., if oral drugs

were usually sufficient for the condition but were not

covered by Medicare).

Requiring PROS to perform prior authorization

for all drug changes during the course of HDIT.

services also may be unnecessary. As one alternative, Medicare could implement more limited safeguards, such as requiring additional patient instruction as to potential complications and mandating

professional supervision during administration of

the first dose of a new drug. Targeted retrospective

review of drug changes by either a PRO or an FI

could identify problems with particular drugs (or

particular providers).

In some circumstances, there may be a need for

ongoing review of a patient’s HDIT to ensure that

the course of treatment continues to be safe and

effective for that patient. In the event of future

Medicare coverage for HDIT, an appropriate regula-

~ PRO Pfior revi~ of w home IV claims was mandated under the MCCA until 1993 and left at HCFA’S discretion thereafter (~).

297-913 0 - 92 - 8
106 ● Home Drug Infusion Therapy Under Medicare

Box S-D—Proposed Scope of PRO Review for Home IV Drug Therapy Services

Under the Medicare Catastrophic Coverage Act of 1988

From the time it received a request for review of home IV drug therapy services from either a physician or a

health care facility, a PRO was to have 8 working hours to determine whether the services were reasonable,

appropriate, and necessary for treatment of the patient’s condition. Before approving home IV drug therapy service,

the PRO was to have determined or to have been assured that:

* the patient’s condition was such that inpatient hospitalization was not justified either:

1) as a continuation of an existing hospitalization, or

2) as a medically necessary and appropriate admission;

 the patient met the selection criteria specified in the regulations (see appendix C);

● the patient and/or caregiver had been or would be sufficiently trained to administer the drugs safely and

effectively in the home;

. the patient or caregiver would independently administer at least one dose of the drug under supervision;

* the plan of care developed by the referring physician had enough information to support coverage of home

IV drug therapy services;

. the covered drug was being used for one of the indications approved by the Secretary of the U.S. Department

of Health and Human Services;

 the drug was medically indicated for treatment of the patient’s condition;

 the prescribed dosage of the drug was correct for the patient’s height, body weight, and other considerations;

● appropriate periodic monitoring had been or would be performed;

● the drug was not contraindicated;

● the home IV drug therapy services prescribed met professionally recognized standards of care; and

. the intavenous route of administration was the only safe and effective route for the patient.

SOtXtC!ES: 1%0 Review of Home IV Drug Thwapy !%rviees, guidelines issued to PROS by the Health Standards and QwdityB-Health

Care Fkumcing Adm.inistratio& September 1989; 54F.R. 173, Sept. 8, 1989.

I

tory body might want to identify specific drugs or tively, prior review could be made the responsibility

conditions that warrant a more intense level of

ongoing review and require that PROS or FIs

perform such reviews.

Finallly, prior authorization of HDIT cases requires the ability for rapid response, since lack of

responsiveness can delay hospital discharge or the

initiation of therapy. Prior authorization of all HDIT

claims within 1 working day might present serious

administrative challenges to PROS. FIs might be an

alternative body that could evaluate the appropriateness of HDIT on a prior, case-by-case basis. FIs have

some experience with current HDIT coverage under

the Part B DME benefit and the Part A home health

benefit (365) (see ch. 6). Prior review might even be

divided between PROS and FIs depending on type of

therapy and the potential for its overuse. For

example, prior review for therapies with which FIs

have limited experience might be placed initially

within the domain of PROS until a sufficient base of

experience has been obtained to develop explicit

review criteria. At that point, responsibility could be

transferred to the FI, who could either continue prior

review or resort to retrospective review. Alternaof FIs from the start, with PROS reviewing only a

random sample of claims retrospectively. FIs might

also be a more appropriate choice than PROS for

conducting change-of-therapy review in cases where

HCFA deems this necessary.

Before the MCCA was repealed, HCFA had

proposed generic quality screens to be used by PROS

in prior review of home IV therapy claims (see box

5-D), as well as retrospective quality of care screens

(53,167,376). HCFA had also developed diagnostic

testing and other special criteria specific to the type

of therapy and diagnosis to be used by PROS for

review purposes (376).

If Congress were to create a new HDIT benefit,

the work begun by HCFA in developing guidelines

and screening criteria for prior and retrospective

review of home IV therapy could serve as a starting

point for the development of final screening criteria.

New criteria would be needed, however, if the

benefit were to cover alternative routes of parenteral

administration, additional drugs, and/or beneficiaries who were not capable of self-care procedures.
Chapter 5—Quality Assurance in Home Drug Infusion Therapy . 107

Quality Assurance for Beneficiaries Who

Receive Care Through Risk-Based Contracts

Under the proposed regulation, HCFA intended

not to extend PRO review (either prior or retrospective) to home IV drug therapy services delivered to

beneficiaries in risk-based health maintenance organizations (HMOs) or competitive medical plans

(CMPs) (54 F.R. 173).24 HCFA reasoned that:

[B]ecause risk-based HMOs/CMPs already have

the clear incentive to prevent unnecessary utilization

of covered health care services, it would be largely

duplicative and, therefore, wasteful to have PROS

use their limited resources to make the same

determinations (54 F.R. 173).

Although PRO utilization review activities may

have been duplicative of existing HMO/CMP initiatives, it is not clear that PRO quality review would

have been duplicative. Because HMOs and CMPs

are paid on a per capita basis for the services they

render to Medicare beneficiaries, they have incentives to control the utilization of potentially costly

services such as HDIT. They do not have as direct an

incentive to control the quality of services delivered.

In 1985, Congress mandated PRO review of

quality of inpatient and outpatient services provided

to these beneficiaries after January 1987 (Public

Law 99-272).25 A recent study by GAO found

serious deficiencies in PRO external review of

quality of care provided in risk-based HMOs, citing

data collection and sampling problems as the major

barriers to adequate oversight (355). The GAO study

also found that HCFA does not adequately assess the

effectiveness of HMO internal quality assurance

programs. Although PRO case-by-case review of

HMO quality of care is mandated, PRO review of

HMOs’ internal quality assurance programs is optional and most HMOs have chosen not to subject

their programs to PRO review (355). The increasing

enrollment of Medicare beneficiaries in risk-based

HMOs in recent years (355) makes it all the more

important to extend any Medicare HDIT quality

assurance efforts (including PRO review) to these

plans.26

u ~enm~ of M~cme&neficfies ~11~ inrisk-wHM@ more than doubled between 1985 ~d 1990 (from 383,480 to 1,238,479) (355).

See 42 CFR part 417 for a description of Medicare contmcts with risk-based HMOs/CMPs.

~ ~blic IAW 99-509 arnend~ this Provisioxq a.llowing HMOS to contract with organizations other than PROS for quality review and _the

effective date of mandated PRO review to April 1,1987. As of Septemba 1990, despite the allowance of Public Law 99-509, all risk-based HMO quality

of care review was being conducted by 30 Me&are PROS (355).

~ H@A has r=nfly propo~ mjor c~es in the PRO review process for HMO/CMP enrollees. The changes, which would bC implemented

sometime during 1992 or 1993 if approved, include a move away from inpatient hospital claims review toward a more comprehensive review of all care

delivered over a 12-month period for a random sample of enrollees (46). HCFA has also proposed tbat PROS conduct a more focused review of records

of deceased beneficiaries (46).
Chapter 6

COVERING HOME DRUG INFUSION

THERAPY: IMPLICATIONS

FOR MEDICARE
Contents

Page

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Costs of Home Drug Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provider Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Payer Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Patient Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Costs to the Health Care System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HDIT Coverage by Non-Medicare Payers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Private Insurers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Medicaid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAMPUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Current Medicare Coverage of HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Applicable Existing Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Extent of Current Medicare Coverage of Home-Infused Drugs . . . . . . . . . . . . . . . .

Impact of Extending Coverage for HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Implications for Medicare Expenditures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Implications for Hospitals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Implications for Technological Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Issues in Extending Coverage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Making Drug Coverage Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HDIT Eligibility and Home Health Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

111

111

111

112

112

113

114

115

116

116

117

117

118

118

122

123

123

124

125

126

126

129

Boxes

Box Page

6-A. The NAIT Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

6-B. Home Infusion Therapy in the Colorado Medicaid Program . . . . . . . . . . . . . . . . . . . . 117

6-C. Defining “Homebound” Under the Medicare Home Health Benefit . . . . . . . . . . . . . 119

6-D. Services and Supplies Covered Under the Medicare Hospice Benefit . . . . . . . . . . . . 121

Table

Table Page

6-1. Prices for Ambulatory Infusion Pumps: Examples From Two Manufacturers,

1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Chapter 6

COVERING HOME DRUG INFUSION THERAPY:

IMPLICATIONS FOR MEDICARE

Overview

Introduction

Medicare, the Federal Government’s insurance

program for the elderly and disabled, does not have

a home drug infusion therapy (HDIT) benefit. No

part of the Medicare insurance plan states that

Medicare will pay for the prolonged administration

of drugs in the home. Yet Medicare does indeed pay

for many of the components of HDIT some of the

time, and during the brief period when the Medicare

Catastrophic Coverage Act (MCCA) was law, it was

explicit Federal policy to extend coverage to HDIT

more generally. The repeal of that act has permitted

a second look at the implications of such a benefit.

As with most other aspects of HDIT, there is little

direct and unambiguous evidence to shed light on

what would happen if Medicare covered the therapy.

This chapter draws on small studies, the health

economics literature, the experiences of private

payers and Medicare carriers, the experiences and

statements of providers, and the findings of previous

chapters of this report to examine the scenario of

Medicare coverage and the various ways it might

play out.

To do so, the chapter first examines the costs (and

benefits) of HDIT from the perspective of the

different actors involved-patients, providers, thirdparty payers, and the health care system as a

whole-and discusses some of the factors that affect

those costs. It then describes the extent to which

Medicare currently covers components of HDIT and

related services. Finally, the chapter discusses some

of the issues and implications of extending Medicare

coverage for the program, its beneficiaries, providers, and technological change.

Summary of Conclusions

. Most patients who have been treated with

HDIT find it preferable to hospital inpatient

treatment. For them, any additional patientrelated burdens of home treatment (in time,

travel, etc.) are more than offset by the advantages of a more normal home and work life.

HDIT can be expensive to provide. Nonetheless, it is widely believed to be cost-saving to

patients, third-party payers, and the health care

system alike. For the kind of patient most likely

to be on such therapy in the past-typically, a

relatively young patient on antibiotic therapy

who has no need of medical or assistive care

other than the infusion-related care-this belief

probably holds true much of the time.

Under other circumstances, however, HDIT is

probably often not less costly to the health care

system than institutional alternatives. These

circumstances are more likely to occur if the

patient is unwilling to bear the responsibilities

of home therapy; if the patient has additional

medical problems or disabilities besides those

that necessitate the infusion therapy; if there is

no unpaid caregiver able to assist the patient at

home; or if the patient’s discharge forces a

hospital bed to lie empty.

Despite the lack of a benefit for HDIT, a

substantial amount of it appears already to be

paid for in some way by Medicare, but this

indirect coverage is neither coordinated nor

equitably applied. Existing coverage is so

fragmented and variable that its extent is

impossible to describe with any accuracy.

Nonetheless, under current rules, the actual

coverage is increasing and will probably continue to do so in the near future, as Medicare’s

administrative contractors use their discretion

to cover drugs as well as the associated

equipment, supplies, and nursing care.

The absence of a coordinated benefit for HDIT

limits the extent of the services that are

provided. It also limits the ability of Medicare

to assess, monitor, or influence the safety,

quality, and effectiveness with which HDIT

services are delivered.

Medicare patients are much more likely than

other patients to have social or medical circumstances that would require a paid caregiver to

administer HDIT. They are also more likely to

need additional assistance with daily living

activities. Thus, while some Medicare patients

-111-
112. Home Drug Infusion Therapy Under Medicare

are ideal and self-sufficient candidates for

HDIT, many would probably have total home

care costs that exceed institutional costs.

Medicare coverage of HDIT would offer opportunities for enhanced quality of life during

treatment for many beneficiaries. It is possible

(though by no means certain) that in the long

run such a benefit might also be cost-saving to

the program. In the short run, however, the

addition of this benefit would raise program

costs significantly, because Medicare cannot

immediately recoup the financial benefits of

shorter hospital stays. The extent of the added

short-run costs, and the likelihood of long-term

cost savings, would depend on the breadth of

the benefit and its administration.

Decisions regarding the exact drugs and conditions to be covered under an HDIT benefit

could be made at the statutory, regulatory,

fiscal intermediary (FI),1 or individual physician level. Of these, decisionmaking placed at

the regulatory or FI level are the most consistent with existing Medicare coverage decisions.

Compared with FI decisionmaking, coverage

decisionmaking at the regulatory level permits

more consistency but less rapid accommodation of new drugs and drug protocols that might

be appropriate for home use.

The Costs of Home Drug Infusion

The costs of HDIT depend on the perspective of

those paying them. For the provider, costs are the

costs of inputs-supplies, services, equipment, drugs,

and administrative overhead. For payers, costs are

payments for the service and administrative time for

the benefit. For patients, costs—and benefits-are in

dollars, time, and ability to participate in other

activities. For the health care system as a whole,

costs are overall resource and opportunity costs.

HDIT is frequently cited as being cost-saving (see

below), but the extent to which it is so depends very

much on the context in which it takes place and the

perspective from which cost savings are analyzed.

On its face, the literature regarding the costs and

cost-effectiveness of HDIT is extremely positive.

With very few exceptions, published studies conclude that HDIT is less expensive than institutional

therapy for presumably equivalent benefit. Since

1978, when the first two reports appeared, at least 17

studies have reported that charges for antibiotic

infusion patients treated at home were less than

those for hospital-treated patients (16,78,101,106,

106a,119,136,148,182a,187,188,267,268,278,324,325,

335). The average reported savings per home patient

in these studies ranged from $510 to $22,232 (22).

A problem in using these studies to infer costeffectiveness of HDIT is that most use only provider

charges, rather than resource costs, for their comparisons of home and hospital therapy. In addition, in

many of the studies, hospital and home patients were

apparently unmatched except for the general type of

therapy. Hospital charges often included surgery and

other inpatient procedures that had no home equivalents, and in some cases, hospital charges were

simply rough estimates.

A more rigorous study of once-a-day intravenous

(IV) antibiotic administration for osteomyelitis was

published in 1986 (101). It, too, found that HDIT

resulted in lower per-patient expenditures. Patients

in the study were assumed to be entirely selfadministering; no allowance was made for outpatient nursing. Collectively, then, the existing literature shows that, for carefully selected patients,

charges for home care can average considerably less

than charges for hospital care.

The actual resource costs of care, however, do not

necessarily bear any relationship to charges. In fact,

it is the difference in the perception of what costs are

relevant, and changes in who is receiving home care,

that explains why HDIT has not diffused even more

rapidly despite the extensive literature on its savings

potential. The

factors.

HDIT is not

following section discusses these

Provider Costs

inexpensive to provide. It requires

special expertise on-the part of nurses; it requires

substantial amounts of pharmaceuticals and clinical

pharmacy services; and it may require equipment

rental as well as a multiplicity of supplies. Once

begun, it cannot be abandoned without institutionalizing the recipient or endangering the patient’s

health. Thus, placing a patient on HDIT requires a

substantial financial commitment on the part of the

provider. There are no studies of actual provider

1 Fiscal intermediaries (part A intermediaries or Part B carriers) are Medicare’s local administrative agents.
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare ● 113

costs of finishing this service; only anecdotal

information is available. One HDIT provider, for

instance, believes its average costs of providing all

drugs, services, and supplies for IV antibiotic

therapy to be roughly $4,000 per month (367).

Costs probably vary considerably among providers. Health care worker wages, for example, are

usually higher in urban than in rural areas (48 F.R.

39752). Wages for nursing services also vary among

providers depending on the qualifications the provider requires of the nurses. The exclusive use of

registered nurses (RNs) with extensive IV therapy

experience, for example, is more costly (and possibly of higher quality) than the use of RNs with

limited experience who perform both IV and other

home health nursing services, because the more

highly skilled nurses command higher salaries

(364). One survey of infusion specialty companies

found that their specialist nurses earned an average

of $17.44 to $20.15 per hour, depending on experience (256).

Costs of supplies and equipment can also vary

considerably among providers for any given therapy. Some providers, for example, use infusion

pumps for almost all the therapies they provide

(364). Others use less expensive gravity drip systems to deliver many antibiotics (364). Even among

pumps, there can be great variation in costs (table

6-l), with the choice of which pump to use

dependent on type of therapy, provider experience,

purchasing arrangements, physician and patient

preference, and patient characteristics.

Providers’ drug costs vary tremendously as well,

even within a single category of drugs such as

antibiotics. Different antibiotics can have dramatically different average prices. Even for a single drug,

providers’ costs of acquiring the drug vary depending on their purchasing power (60,331).

The kinds of patients seen will affect both supply

and nursing costs. Providers with a high cancer or

AIDS2 caseload, for example, may spend more per

patient than other providers because these patients

often require multiple therapies and the administration of highly toxic drugs that require pumps to be

administered safely (see chs. 2 and 3). Similarly,

providers who serve large numbers of elderly or

Table 6-l—Prices for Ambulatory Infusion Pumps:

Examples From Two Manufacturers, 1991

Manufacturer/pump Pump pricea

Pharmacia Deltec

CADD-HFX . . . . . . . . . . . . . . . . . . . . . . . . . .

CADD-PlUS . . . . . . . . . . . . . . . . . . . . . . . . . .

CADD PCA2 . . . . . . . . . . . . . . . . . . . . . . . . .

CADD-TPN pump . . . . . . . . . . . . . . . . . . . . .

CADD-TPN system . . . . . . . . . . . . . . . . . . .

lvion Corp.

Walkmed 300 . . . . . . . . . . . . . . . . . . . . . . . .

Walkmed 410 . . . . . . . . . . . . . . . . . . . . . . . .

Walkmed 420 . . . . . . . . . . . . . . . . . . . . . . . .

Walkmed 430 . . . . . . . . . . . . . . . . . . . . . . . .

Walkmed 440 . . . . . . . . . . . . . . . . . . . . . . . .

lntelliJect@ . . . . . . . . . . . . . . . . . . . . . . . . . .

$2,595

3,395

3,495

3,595

3,995

1,860

2,095

2,695

2,695

3,095

5,400

apri~9 are those quoted to the Office of T=hnology Assessment by the

manufacturers in October 1991. It ispossibtethatthe actual prfees ptdd by

some providers are Iowerthan the prices listed here (e.g., if the providers

obtained discounts from the manufacturers).

SOURCES: M. Moraezewski, Pharmaeia Deltee, St. Paul MN, personal

eommunieation, Oct. 7, 1991; R.P. Nelson, Ivion Corp.,

Broomfield, CO, personal eommunieation, Oct. 7, 1991.

disabled patients are likely to have higher nursing

costs per patient than other providers, because these

individuals may need more assistance with their

therapies and other health and personal care needs

(see ch. 3).

There may be some tradeoff between nursing and

supply costs. The use of a preprogrammed pump, for

example, may allow an elderly patient to go home on

therapy without the need for a paid nurse to

administer each dose. The actual extent to which

more sophisticated drug delivery systems may

reduce nursing costs, and for which patients, is

undocumented and apparently unknown.

Payer Costs

The costs of HDIT to a third-party payer-e.g.,

Medicare, Medicaid, or private insurance-are the

amount that the insurer pays for the therapy and any

associated health care services necessary to provide

it.3 This amount may simply be the providers’

charges for the therapy and associated services,

minus any coinsurance or deductible paid by the

patient. Alternatively, the insurer may pay on some

other basis, such as a fee schedule or a rate

negotiated beforehand with the provider.

Much of HDIT’s early success and rapid diffusion

into the health care system has derived from

2 Acquired immunodeficiency syndrome.

s In some case~.g., in some health maintenance orgsnizstions-the provider and the insurer maybe the same entity. In this case, the insurer’s

costs are simply the costs of providing the service.
114. Home Drug Infusion Therapy Under Medicare

providers’ ability to convince insurers their payments will be less for home than for hospital therapy.

But in 1992 this is not always the case, despite the

evidence that home care charges have historically

been lower.

Insurers’ home care payments are sometimes

higher than hospital payments for two reasons. First,

the most important contributor to the lower historical charges for home infusion is the replacement of

paid room, board, and labor in the hospital with their

unpaid equivalents in the home. All of the studies

that reported lower charges for HDIT required that

home patients be able and willing to carry out their

infusions with the help of a family caregiver. But

HDIT in the 1990s is by no means limited to

self-infusing patients (250,364), and total home

charges for patients who require paid assistance may

exceed hospital charges for equivalent care (204).

This may be particularly true if, in order to substitute

home for hospital care, the patient needs not only

assistance with the infusion but help with other

activities as well (e.g., dressing and bathing).

Second, the relationship between payments and

charges differs for hospital and home therapy.

Medicare, Medicaid, and private insurers now often

pay hospitals much less than actual charges.4 But

insurers that pay directly for HDIT often still do so

on the basis of home provider charges, because they

have little other basis for establishing payment rates

(55). Consequently, according to insurers, payment

for HDIT can sometimes exceed payment for

equivalent hospital care even for the most selfsufficient patients.

For example, one insurer told the Office of

Technology Assessment (OTA) that it had received

claims for a patient with Lyme disease in which the

charge for self-administered home IV antibiotic

therapy was over $650 per day. Based on its hospital

payment experience, the insurer believed that hospital care for this patient would have been considerably cheaper than home care at the charged rate

(367).

The difficulty in realizing cost savings to the

payer is particularly acute for third-party payers that

reimburse for hospital inpatient care at a fixed rate

per patient discharged. In this case, the hospital

payment remains the same regardless of whether the

patient is discharged home after a few days or

remains hospitalized for several weeks. From the

payer’s perspective, home care payments simply add

to, rather than substitute for, hospital payments

under such a system (243). Only when hospital care

is averted altogether can the payer reduce its costs.

Patient Costs

Patient-associated costs of HDIT fall into three

categories. First, and most obvious, are direct

medical costs. In the extreme, when no third-party

coverage applies, these costs include the purchase

prices for all of the products and services directly

related to the therapy. Because these costs are very

high for most patients, HDIT is probably rarely

provided to such patients except as charity care.

When the patient’s insurer does cover home therapy,

the patient’s direct medical costs include any insurance copayments (i.e., coinsurance and deductibles)

and any provider charges uncovered by the insurer

(e.g., charges greater than the payer’s allowed

charge and charges for any luxury or nonprescribed

items).

Nonmedical costs (e.g., food, electricity, and

transportation costs) can be equally important to

home patients. Some of these, such as food, become

“medical costs” and are covered by insurance when

provided in a hospital. Finally, patients on prolonged

infusion therapy also bear indirect costs associated

with the therapy, such as time lost from family

responsibilities and leisure activities, lost income,

family stress, and psychological discomfort.

It is the lessened indirect costs often associated

with HDIT that account for its popularity with

patients. Patients with strict school, work, or home

responsibilities (e.g., caring for another family

member) can be very vocal and articulate in their

preference for HDIT (364). In studies reporting on

patient satisfaction and activities during HDIT, most

home patients were able to resume their normal

activities while on treatment (106,188). Even those

without employment or other outside commitments

may find home infusion attractive because it permits

the patient to engage in outside recreational activities and a normal social life (364). No studies have

4 Medicare and Medicaid have paid less than actual charges for many years. More recently, the increase in managed-care programs such as preferred

provider and health maintenance organimations (which together make up over one-fourth of the group insurance market) (150) means that many private

insurem also receive substantial discounts off of hospitals full charges.
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare . 115

been performed on the extent to which elderly

patients requiring infusion therapy prefer one site of

care over another, but there is no reason to think they

would value the relative freedom of home care less

than most other patients.

Costs to the Health Care System

Whether paying for HDIT costs more or less to the

overall health care system than not paying for this

service cannot be answered by examining either

provider, payer, or patient costs in isolation. HDIT

is cost-saving to the system if (and only if) the net

health care resources required to provide this service, and any adjunct services needed at home, are

fewer than those required to provide equivalent

therapy and services in alternative settings.

The comprehensiveness of this requirement is

critical. It is the total package of care required by a

patient in order to be treated at home just the

infusion therapy-that must be compared with care

in alternative settings in an evaluation of relative

health system costs. If a patient needs help with

bathing and N site dressing (bandage) changes in

order to be treated at home, the costs of providing

those home services must be counted as part of the

costs of being able to receive HDIT. Depending on

the way benefits are defined and paid, HDIT can be

cost-saving to any individual payer without necessarily saving health system resources overall, and

vice versa.

The three basic settings for drug infusion therapy

that are alternatives to the home are hospitals, while

the patient is an inpatient; ambulatory care settings,

such as outpatient clinics and physician offices; and

skilled nursing facilities (SNFs) (including selfdefined subacute care facilities). There are no

studies of the resource costs of providing drug

infusion therapies in any of these settings. However,

it is possible to explore some of the factors that

influence relative costs under different circumstance.

Need for Professional Services

In the extreme, if a patient needs 24-hour skilled

nursing in order to be able to receive drug infusion

therapy at home, the home is highly unlikely to be a

cost-saving setting for treatment. In this instance, the

nurse can care for only a single patient, a situation

that is very resource-intensive and that can be more

expensive than most hospital care (204,362a).

In contrast, the home is likely to be a relatively

efficient setting for a patient who requires no

professional care at all except for the initial training.

Since the training itself is a resource cost not

incurred by institutionalized patients, the relative

cost savings for such patients increases with the

length of time on therapy. This potential for great

savings over time for independent and relatively

healthy patients was one of the spurs behind the

decision by Medicare in 1977 to pay for home

therapy for patients requiring long-term total parenteral nutrition (TPN) (359).

Cost of Travel and Care Coordination

Home therapy, in contrast to inpatient- or clinicbased therapy, requires a considerable amount of

provider time spent in activities other than direct

patient care, such as travel between patients and

coordination among relevant providers (physician,

pharmacist, nurse, etc.). Where the costs of conducting these activities are high, home care may be

relatively more resource-intensive. For example, if

a patient needs professional supervision for a

4-times-a-day infusion regimen, requiring multiple

daily trips by the nurse, home care may be more

costly to the health care system than equivalent care

provided in an SNF. Patients with many complex

health care needs, of which infusion therapy is only

one, may be similarly less expensive to care for in a

health care setting that can offer the array of needed

services on-site.

Providers of clinic-based outpatient infusion therapy maintain that this setting is more efficient than

home care for treating many patients (340,340a).

The ability of outpatient clinics to maintain all

needed services on site, with personnel in constant

communication, suggest that this assertion may well

be true for at least some patients.

Institutional Occupancy Rates

Treating patients at home rather than in the

hospital cannot be cost-saving to the health care

system if hospitals are unable to either eliminate

beds and associated services or put the beds and

services to better use (e.g., by transferring into the

now-open bed a patient previously being treated in

the intensive care unit). Where hospitals have

unoccupied beds and underutilized staff, continuing

treatment in the hospital may well be less expensive
116 ● Home Drug Infusion Therapy Under Medicare

Box 6-A—The NAIT Survey

The National Alliance for Infusion Therapy (NAIT), an association of “providers and manufacturers of home

infusion services, equipment, and products,” sponsored a survey of data from nine of its members in 1990. The

survey’ goal was to "identify types of available data and obtain preliminary information about industry and patient

characteristics.’ It included the following components:

1. National patient census. The contractor performing the survey (Coopers & Lybrand) collected

cross-sectional data for March and September 1990 to obtain a complete census of all home infusion therapy

patients considered “on service” at that time in eight participating companies. This census (42,700 patients

on Sept. 30, 1990) was then analyzed according to variables of interest (e.g., geographic location).

2. Patient-specific data sample. From a stratified sample of 86 branch offices of companies participating in

the survey, the contractor then sampled 2,506 patient records to identify patient-specific demographic,

clinical, service, and therapy information. Patients were selected for the sample only if they received one

or more of the following infusion therapies during the 2-week sample period: antibiotics, antineoplastics,

pain management, total parenteral nutrition, and enteral nutrition.

3. Patient education survey. The contractor separately surveyed a small sample of previously hospitalized

patients who were receiving services from participating companies regarding the infusion-related education

and training they received in the hospital before discharge.

4. Site visits to four branches of three companies and one corporate office to obtain operation and service

delivery information.

5. A review of the published literature regarding home infusion therapy services, costs, and wages for skilled

employees.

6. Longitudinal data for a subset of all previously surveyed patients who were discharged from home infusion

service during the period Sept. 9, 1990 through May 31, 1991. (Late reporting and incompleteness made

these data of questionable reliability.)

SOURCE: A.K. Parwx and K. Lir@ National A1.lianeefor IofusionTherapy, WasbingtoQ DC, memorandum to E. Power, Off3ce of ‘Ikdmology

Assessment oet. 30,1991.

to the health care system than treating that patient at Private Insurers

home (at least in the short run). Conversely, if

institutional beds are fully occupied, home care Most HDIT is paid for through private insurance.

becomes a relatively more efficient setting, because Several providers who specialize in home drug

the alternative is to build more institutional beds. infusion (as opposed to TPN) report anecdotally that

over three-fourths of their patients have private

third-party coverage (83,343).5 The NAIT survey

HDIT Coverage by Non-Medicare Payers found that almost 64 percent of patient records

sampled listed private insurance as the payer and an

Most health care third-party payers cover HDIT at

additional 14 percent had a combination of private

insurance and Medicare (256).

least some of the time. Coverage increased substantially during the 1980s, as the technology became Similarly, most private insurers cover HDIT to at

more developed, providers became more adept at least some extent. A 1987 survey of coverage for

convincing payers of its worthiness, and payers home IV antibiotic therapy found that of 50 Blue

became more familiar with it. In a 1990 survey of Cross/Blue Shield programs, 47 covered this servrecords of some infusion companies that are mem- ice, although 34 required that it receive prior

bers of the National Alliance for Infusion Therapy authorization before coverage commenced (21).

(NAIT), less than 4 percent of patients had no This survey likewise found that most commercial

third-party coverage of any kind for their therapy insurers and all of the 19 responding health mainte-

(257). (Box 6-A describes the NAIT survey.) nance organizations covered this therapy, with about

5 Because Medicare covers TPN, providers specializing in this form of infusion therapy would be expected to have a higher proportion of Medicare

patients (and a lower proportion of privately insured patients) than those specializing in HDIT
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare . 117

half of each group requiring prior authorization (21).

These results, now 4 years old, probably understate

current coverage; the continued expansion and

financial well-being of the HDIT industry suggests

that coverage for the therapy is widespread.6

Medicaid

Medicaid is a federally aided, State-administered

program that provides medical assistance to roughly

26 million low-income people (114). Although the

Federal Government sets some minimum standards,

the actual services offered by individual State

Medicaid programs vary widely among the programs.

All State Medicaid programs cover the basic

components of HDIT in some fashion (although they

do not necessarily pay generously). Durable medical

equipment (DME) and home care services for adults,

for example, are federally mandated benefits under

the program. Prescription drugs are optional, but as

of 1990 all 50 States and the District of Columbia

covered them (373).

More comprehensive coverage of HDIT, however, is not so universal. A 1987 survey of the 50

State Medicaid programs, sponsored by HoffmannLa Roche, found that 48 of the 50 States paid for

home IV antibiotic therapy (21). Of these 48

programs, 29 required that the service receive prior

approval before it would be covered. At least one

Medicaid program has documented that HDIT has

been cost-saving to the program (box 6-B).

CHAMPUS

The Civilian Health and Medical program of the

Uniformed Services (CHAMPUS), operated by the

Department of Defense, is an example of another

government health care program that covers HDIT

in at least some cases. CHAMPUS pays for the

medical care needed by dependents of active and

retired military personnel when that care cannot be

obtained from a military hospital. The program

covers home infusion therapy both under its basic

benefit package and through two ongoing home

health care demonstration projects. Coverage is

generally broad, but it is probably somewhat erratic

Box 6-B—Home Infusion Therapy in the

Colorado Medicaid Program

A review of claims for home infusion therapy

submitted to Colorado’s Medicaid program found

satisfactory results of this coverage for that program. Researchers found that 61 patients were

treated at home, based on claims submitted over a

26-month period. Most of these patients were

treated with anti-infective drugs. The remainder

received either other infused drugs or total parenteral nutrition (TPN) (85).

program savings for the period were estimated to

be at least $125,000 (1988 dollars). The program

resulted in a significant shift of Medicaid resources,

from hospital spending (which decreased by au

estimated $430,000 due to the program) to expenditures for nonhospital pharmacy services (which

increased by nearly $100,000). Anti-infective therapy was the greatest overall contributor to savings,

due to its large share of patients, while pain

management resulted in the greatest per-patient

savings. In this study, home TPN was found to

result in little or no program cost savings (i.e., it did

not reduce Medicaid expenditures) (85).

in its implementation due to the individualized

nature of many coverage decisions.

CHAMPUS basic home health benefits include

medical equipment, skilled nursing care, drugs and

medical supplies, and physician visits. The program

has little formal policy regarding what types of home

infusion therapies are covered; all decisions are

made on a case-by-case basis, and informal coverage

policies (mostly in the form of specific exclusions)

are based on accumulated claims experience (20).

However, coverage for HDIT appears fairly broad.

Except for beneficiaries requiring custodial care (to

whom limits on nursing services apply), unlimited

home health visits to CHAMPUS beneficiaries are

covered if they are medically necessary and if the

patient is either “homebound” or services are

otherwise determined to be needed in the home.7

Infused drugs are covered, but only if they are

approved by the Food and Drug Administration

G The f~cid well-being of the ~~ market is suggested by the fact tha~ according to market analyst estimates, industry revenues grew by over

30percentper year between 1986 and 1988 and were predicted to continue to grow by over 25 percent per year through IW1 (275). Companies likewise

continue to perceive the HDIT industry as a growing one, and of the top 10 companies in the home care industry (defined by total revenue), 7 derive

at least a quarter of their revenue fium home infusion therapy, including HDIT (392).

7 CHAMPUS has no working deftition of “homebound,’ and fiscal intermediaries may be applying the restriction rather liberally (20).
118. Home Drug Infusion Therapy Under Medicare

(FDA) for both the particular route of administration

and the particular condition (19).8

In contrast, under the ongoing demonstration

projects, drugs may (on a case-by-case basis) be

covered for unapproved uses if they are widely used

for those purposes (269).9 In general, the demonstration projects require that a patient have an alternate

caregiver in order to receive home infusion therapy.

However, CHAMPUS has paid for additional assistive services on occasion (269).

Current Medicare Coverage of HDIT

Applicable Existing Benefits

Medicare, the Federal Government’s health insurance program for aged and disabled individuals, has

no defined benefit that covers HDIT. Infusion

therapy of any kind has been considered in the past

to be an institutional rather than a home service.

Even TPN, which has been covered by Medicare

since 1977, is covered under the prosthetic device

benefit (as a replacement for the digestive system)

rather than as a home infusion therapy benefit.

Nonetheless, there are a number of existing

benefits under which patients can get certain components of drug infusion therapy covered at home. The

total number of Medicare patients who receive some

coverage for home infusion therapy is unknown but

probably extensive. However, the coverage that

exists is also highly fragmented, nearly always

incomplete, and varies enormously depending on the

location and circumstances of the patient.

Medicare is separated into two parts: Part A,

which covers hospital, skilled nursing facility, home

health, and hospice care; and Part B, which covers

physician and related services, hospital outpatient

services, nonhospital laboratory services, and medical equipment and supplies.10 Existing benefits that

currently serve as “back door” mechanisms for

HDIT coverage include:

1. Part B DME benefit,

2. Part A home health benefit,

3. Part B diagnostic laboratory services benefit,

4. Part B physician services benefit,

5. Part B hospital outpatient benefit, and

6. Part A hospice benefit.

Each of these benefits and its relation to HDIT is

described below.

Part B Durable Medical Equipment

The Medicare DME benefit is the most broadly

available mechanism through which Medicare covers some of the components of HDIT. To be eligible

for this benefit, a beneficiary usually need only have

a physician certify that the equipment: 1) is furnished to that person in his or her home,11 and 2) is

medically necessary to ameliorate illness or injury or

to improve functioning of a malformed body part.

Infusion pumps and IV poles qualify as DME.

Medicare also covers medical supplies and accessories necessary for the proper functioning of the

equipment (74). Thus, supplies such as tubing,

needles, and alcohol swabs would be covered when

a pump is covered.

Equipment must be capable of withstanding

repeated use to qualify as DME. Single-use infusion

control devices (e.g., elastomeric infusers-see ch.

3) do not qualify. Also, equipment with certain

convenience or luxury features are covered in full

only if those features are deemed medically necessary for the patient’s condition (74). Thus, Medicare

presumably would not cover a sophisticated infusion

pump if the drug to be infused could be delivered

safely and effectively through a less expensive

gravity drip system. Furthermore, because a gravity

drip system (with the exception of the IV pole) is not

considered DME, related medical supplies would

usually also be excluded from coverage in this

instance.

The coverage of supplies and accessories related

to the DME explicitly includes “drugs and biologicals that must be put directly into the equipment to

assure proper functioning of the equipment” (74).

8 CHAMPUS does not cover dregs for unapproved uses; for example, the FDA has not approved terbutaline for use in preventing preterm labor, so

it is excluded from CHAMPUS coverage (20). The only exception to this general policy is tbat, under a proposed and soon to be final rule, CHAMPUS

will cover class III investigational cancer drugs listed by the NationaJ Cancer Institute (20).

9 For example, CHAMPUS does cover home-”mi%sed terbutaline for high-risk obstetric patients under the demonstration program. They have

experience with about 60 patients, and staff believe the therapy to be effective in prolonging pregnancy (269).

10 Home he~th stims can alSO be covered under Part B for beneficiaries who are ineligible for ~ A bntilts.

11 For the Pvsm of ~s &#lt, a “home” is def~~ ~ tie patient’s pl~ of residence, but tie definition excludes iIIStit’UtiOIIS Or diSbCt pof institutions that meet the basic defiition of a hospital or a skilled nursing facility.
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare ● 119

Box 6-C—Defining “Homebound” Under the Medicare Home Health Benefit

For much of Medicare’s history, “homebound” was written in the statute as “confined to the home” and

appeared at only two places in the Social Security Act (sections 1814(a) and 1835(a)). Over the years, the Health

Care Financing Administration (HCFA) attempted to clarify the definition through guidelines and examples in the

Medicare Intermediaries’ Manual. The guidelines essentially restricted qualifying beneficiaries to those unable to

leave the house by any means to get medical care, although the manual specified a few exceptions (e.g., trips to

church, trips to the doctor for medical care that couldn’t be delivered at home) (379). Still, intermediaries’

interpretations of “homebound” were apparently highly varied (167).

The omnibus Budget Reconciliation Act of 1987 (Public Law 100-203) attempted to further clarify the

meaning of “homebound” by specifying in statute that:

. . . an individual shall be considered to be ‘confined to his home’ if the individual has a condition, due to an illness

or in., that restricts the ability of the individual to leave his or her home except with the assistance of another

individual or the aid of a supportive device (such as crutches, a cane, a wheelchair, or a walker), or if the individual

has a condition such that leaving his or her home is medically contraindicated. While an individual does not have to

be bedridden to be considered ‘confined to his home,’ the condition of the individual should be such that there exists

a normal inability to leave the home, that leaving home requires a considerable and taxing effort by the individual,

and that absences of the individual from home are infrequent or of relatively short duration, or are attributable to the

need to receive medical treatment” (SSA secs. 1814(a), 1835(a)).

Despite this effort to bring some uniformity to the application of the “homebound” restriction, continued

ambiguity in the definition of “confined to his home’ will most likely lead to continued differences in intermediary

interpretation and practice. HCFA intends to publish regulations that attempt to explain the new statutory language

in more detail (167).

The interpretation of this clause, however, is left to Part A Home Health Services13

the discretion of the FI (i.e., the Part B carrier) (155).

To clarify what drugs might be appropriately cov- The Medicare home health benefit is a source of

ered through this provision, the Health Care Financ- coverage for skilled nursing services associated with

ing Administration (HCFA) inserted language in the home infusion for Medicare beneficiaries. To be

Medicare Carriers Manual that instructs carriers to eligible for Medicare-covered home health services,

cover the cost of external infusion pumps and however, a beneficiary must be “confined to his

associated drugs when used for the administration home’—i.e., unable to leave his home without the

of:

●

●

●

●

deferoxamine to treat acute iron poisoning or

iron overload;

heparin to treat thromboembolic disease and/or

pulmonary embolism (in institutional settings

only);

antineoplastic therapy to treat liver cancer

patients who cannot or will not undergo surgical treatment; and

morphine to treat cancer patients for intractable

pain (378).

assistance of another person or a supportive device

(379). The legislative definition of “confined to his

home’ has been broadened in recent years (see box

6-C). However, it is still both fairly restrictive and

somewhat ambiguous, and there is still variation

among Medicare intermediaries in interpretation of

the rule (167).

The homebound requirement effectively eliminates a large number of the least disabled patients on

drug infusion therapy from any nursing coverage

offered under the home health benefit. For example,

– 

patients who are otherwise healthy and nondisabled

This language neither requires nor prohibits carriers but require continuation of an 8-week course of

from covering other drugs under this same general antibiotic therapy would not qualify for any home

rubric .12 health services because they are not homebound.

12 HCFA does explicitly prohibit cove~e of extew infusion pumps for the subcutaneous administration of insulin to diabetic patients (378).

13 6’Homeh~thsewices~ * ~cova~~erpmA~ess the ~nefici~ has exhausted his or her Part A coverage, in which case coverage is ~der

Part B (74).
120. Home Drug Infusion Therapy Under Medicare

Beneficiaries eligible for home health benefits

also must be under a physician’s written plan of care

and must be in need of either part-time or intermittent skilled nursing care or skilled physical or speech

therapy services (379). Nearly all patients requiring

home infusion would meet this qualification. Thus,

most infusion patients who were also homebound

would be eligible for other home health benefits not

related to the infusion therapy as well.14

Two home health benefits are especially relevant

to HDIT patients. These are:

Part-time or intermittent skilled nursing services provided by or under the supervision of a

registered nurse (RN) (379). Patients qualify if

they need up to 28 hours per week of skilled

nursing and home health aide services combined at less than 8 hours per day, or up to

full-time (8 hours per day) on a temporary basis

(up to 3 weeks). The need for services up to 35

hours per week of skilled nursing and home

health aide services combined at less than 8

hours per day (or on less than a daily basis) may

be approved on a case-by-case basis (379).

Through this benefit, most skilled nursing

services required for HDIT would be covered.

DME and medical supplies. Covered supplies

include presumptively medical supplies (e.g.,

needles, wound dressing supplies) as well as

ordinarily nonmedical supplies that are deemed

necessary for the patient’s medical condition

(e.g., lotions or soaps that serve a particular

therapeutic purpose). Unlike the part B DME

benefit, drugs and biological are specifically

excluded from DME provided under the home

health benefit (379). Nonetheless, this benefit

permits the rental or purchase cost of an

infusion pump and all HDIT-related medical

supplies except the drugs (e.g., tubing, catheter

The

●

●

●

●

replacements, dressing supplies, alcohol swabs)

to be covered.

home health benefit also covers:

skilled physical, speech, and occupational therapy services,

part-time or intermittent services of a qualifed

home health aide,15

medical social services,16 and

home medical services of residents and interns

in approved teaching programs with which the

home health agency is affiliated (74).

All covered services must be furnished by or under

arrangement with a Medicare-certified home health

agency (HHA) (74).

Part B Diagnostic Laboratory Services

Medicare’s Part B diagnostic laboratory services

benefit covers nonhospital diagnostic laboratory

services that are ordered by a physician, including

laboratory tests to monitor the status of an HDIT

patient (74,378).17 Skilled health professional services required to obtain laboratory specimens (e.g., a

lab technician to draw blood) and travel costs of

laboratory personnel for the purpose of collecting

specimens from homebound persons are also covered (378).

Part B Services Incident to a Physician’s Services

Services and supplies (including drugs and biologicals that cannot be self-administered18) furnished incident to a physician’s professional services are covered under Part B of Medicare. Nonphysician services (e.g., nursing services) covered under

this provision usually must be performed under the

direct supervision of the physician by individuals

under that physician’s employ (378).

M me N~T -wfo~ ~12 ~xmt of w p~ents ~ its -le Wme no~~ato~ (~d thUS mi@ qualify x homebound) (256). The

proportion of elderly patients on HDIT who might quali@ is probably considerably higher, since most patients in the NAIT sample were under age 65.

15‘rhepww of h~meh~th~defiits must~ toprovide~ds-on~rso~ c~e or ~~icesn~es~for the health or fI~tment Of ~ehefiCi~

(e.g., simple dressing changes, assistance with orid medications). !kxvices of a home health aide are not considered reasonable and necessary if there

is a family member or other caregiver available and willing to perform thexw however, it is customary to presume that no caregiver is available unless

the beneficiary or a family member indicates otherwise or the home health agency has knowledge to the contrary (379).

16 ~wples of m~~ SWM s~ims include: counseling services, community resource identiilcatiou assessment of resource COOrdiMtiOU md

assessment of social and emotional factors related to the beneficiary’s condition and treatment (379).

17A ctic~~hmtow titis part of a hospiti is comidti an independent laboratory when it provides services to nonpatients (378). If the same

hospital laboratory provides services to the hospital’s outpatients, such services are covered under the Part B outpatient hospital services benefit (74).

1s ~~venomly administer~ drugs are generally not considered by HCFA to b @f-~“ “ tered drugs (378).
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare . 121

In certain unusual circumstances, however, Medicare can waive the direct supervision requirement.19

Specifically, for homebound patients who live in

areas not served by any Medicare-certified HHA,

Medicare will cover a number of skilled services

when provided by nonphysicians, including injections, venipuncture, dressing changes, and patient

training activities (378). HCFA has no information

regarding the extent to which services are billed

under this waiver (76,143). The increase in the

number of certified HHAs (from 2,212 in 1972 to

5,673 in 1990) (353), however, suggests at least that

the need for such a provision has decreased.

Medicare coverage of services furnished incident

to a physician’s services are more commonly

relevant to infusion services in the context of

outpatient infusion. Through this coverage rule,

Medicare covers the nursing services and supplies

for infusions performed in physicians’ offices. Some

carriers apparently restrict such outpatient infusion

coverage, however. For example, an IV antibiotic

provider in the State of Washington reports that its

carrier will cover office-based infusion only for

certain medical conditions (146).

Part B Hospital Outpatient Services

As with physicians’ offices, hospital outpatient

departments already qualify for payment for their

various nursing activities and medical supplies, and

outpatient infusion provided in this setting is reimbursable. Medicare covers laboratory services, durable medical equipment, visits, medications, and

medical supplies provided in hospital outpatient

departments (273). Furthermore, payment for most

services in this setting is on the basis of reasonable

costs, making it potentially financially attractive to

hospitals able to organize and maintain an outpatient

clinic.

Through this mechanism, Medicare may cover

not only infusions performed in the clinic itself but

the costs of visits for skilled nursing services (e.g.,

catheter site changes) when a patient is performing

the daily infusions at home. The extent to which the

benefit is used for either purpose is unknown.

Box 6-D—Services and Supplies Covered

Under the Medicare Hospice Benefit

Supplies and services covered under the Medicare hospice benefit include:

. nursing care;

. medical social services;

● physicians’ services;

. counseling services for the patient and familly

members;

● short-term inpatient hospice care;

. drugs and biological that are used primarily

for pain and symptom control;

. medical equipment and supplies related to pain

and symptom management;

. physical, occupational, and speech therapy;

and

 home health aide and personal care services

(including personal comfort and custodial care

items as necessary).

Nursing and home health aide services are covered

on a 24-hour basis only during periods of crisis.

SOUR~: Commerce Clearing House, Inc., A4edicum und

Medz”ca&.iGzddk (chiC~O, ~:~~,k., 1990).

Part A Hospice Care

Terminally ill patients (those with a life expectancy of 6 months or less) are eligible for the

Medicare hospice benefit. This benefit focuses on

palliative treatment, symptom control, and home

care rather than on curative treatment. When a

beneficiary elects hospice care, he or she becomes

ineligible for most other Medicare benefits.20

Hospice care must be provided by a Medicarecertified hospice program. Hospice care services and

supplies (see box 6-D) are covered by Medicare if

they are reasonable and necessary for the palliation

or management of the patient’s terminal illness and

are included in a written plan of care that is reviewed

periodically by the patient’s physician. The hospice

program must provide all these services directly or

through arrangements with other approved entities.

Any home infusion services provided by the

hospice are covered under a daily rate. Hospices may

19 me s~ic~ must still be provided under general physician supcmision. “General supervision” requires that the service(s) be ordered by the

physiciq that thephysicianmaintain contact with the professionals performing the service(s), and that the physician maintain professional responsibility

for the service(s) (378). (In contras~ “direct supervision” requires that the physician be on site.)

~ Semices of such aphysici~ the patient’s attending physiciam who is not an employee of the hospice continue to be reimbursable wdm Mediae

Part B (74).

297-913 0 - 92 - 9
122. Home Drug Infusion Therapy Under Medicare

be discouraged from providing such services either

because they are too costly, too complicated to

provide, or both (26). Some hospices, for example,

do not accept patients who are on TPN (30).

(Although TPN is covered under the Part B prosthetic device benefit, beneficiaries who have elected

the hospice benefit are no longer eligible for such

coverage.) The bulk of home infusion therapy

provided under the hospice benefit is believed to be

for pain management (26). Pain management administered by infusion pump is considered a “highcost” service by providers, and although hospices

generally prefer less costly alternatives, they will

generally pay for a pump system if it is requested by

the physician (26).21

The Extent of Current Medicare Coverage

of Home-Infused Drugs

The primary means by which Medicare currently

covers HDIT are the home health benefit, which

enables homebound persons to receive coverage for

infusion-related nursing, and the DME benefit,

which permits Medicare beneficiaries who need

them to receive infusion pumps and related supplies.

It is the latter benefit that allows patients to receive

some drugs, with the extent of drug coverage

dependent on the Medicare carrier’s discretion.

These two complementary benefits can, at times,

enable a Medicare patient to receive reasonably

comprehensive (but uncoordinated) home infusion

benefits. The patient, if homebound, may qualify for

the home health benefit through the need for

intermittent infusion-related nursing, while billing

for drugs, equipment, and supplies through the Part

B DME benefit.

To assess the extent to which carriers actually

cover home-infused drugs through the DME benefit,

OTA conducted a survey of all 43 carriers in the

United States.22

As of February 1991, all of these carriers had

policies to cover at least the three drugs explicitly

permitted by HCFA for home treatment of specified

conditions: morphine for intractable cancer pain,

antineoplastic therapies for certain cancers, and

deferoxamin e for iron overload. Seventeen carriers

covered only the drugs and conditions specified by

HCFA, and some placed additional explicit restrictions on coverage (e.g., treatment was covered only

it begun in a health care setting). At the opposite

extreme, however, many carriers covered not only

the drugs permitted by HCFA but a wide variety of

other drugs as well. For example, 24 carriers

reported that they at least sometimes cover analgesics other than morphine; 18 at least sometimes

covered antibiotics; and 3 carriers covered dobutamine (365).

A few carriers even reported covering, through the

DME benefit, certain drugs that are not administered

via infusion pumps. One carrier covered antibiotics

when administered through a gravity drip system,

and one covered hydration therapy in terminally ill

patients when the therapy was administered by

gravity drip (365).23

The results of this survey prompt two conclusions.

First, there is clearly great variability in DME

coverage policy among carriers, from carriers who

cover only the HCFA-listed drugs under the most

stringent conditions to carriers who cover even drugs

not administered through a pump. Second, the

amount of HDIT that is already being covered by

Medicare is significant and is increasing rapidly.

Both the categories of drugs that carriers are willing

to cover and the number of claims for drugs in those

categories appear to be rising.

Antibiotics and dobutamine coverage policies

present striking examples of the rapidity with which

coverage-and claims-are increasing:

●

●

●

Three of the 18 carriers that covered at least

some antibiotics had begun doing so only very

recently, and one noncovering carrier was

considering extending coverage to antibiotics

at the time of the survey.

Seven carriers said that claims for antibiotics

were frequent and submitted in increasing

numbers.

Of the three carriers that said they would cover

dobutarnine at home, one had yet to see a claim

21 me issue of hi~-cost services provided by hospices is currently Waler eJK* tion at Project HOPE as part of a congressionally requested study

(26).

~ ~ese ~~ti~te w of tie carriers covering the United States and the District of Columbia. Attempts to include Puerto Rko’s her ~ tie ~eY

were unsuccessful.

?.3 W. ~emrepfi~~t~eyevacover~ a~oso~Pn~~e under the DMEbenefit. OTAdid not follow up s~eYresPo~es~d so c~ot

confii this.
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare . 123

for it. The other two had both instituted

coverage only very recently; one had seen only

a single claim so far, while the other carrier

estimated that dobutamine already accounted

for 10 percent of its drug claims under the DME

benefit (365).

An interesting characteristic of current coverage

of home-infused drugs is that because changes are

made incrementally at the local level, and because

two of the three drugs sanctioned by HCFA are for

cancer therapy, patients with severe cancer have the

greatest coverage. In the survey, all carriers covered

morphine and some antineoplastics, and most also

covered some other related drugs (e.g., other analgesics). Furthermore, where carriers covered additional categories of drugs, coverage was sometimes

limited to patients already receiving other therapies.

For example, four carriers covered adjunct therapies

(e.g., hormonal therapies) for patients currently

receiving home antineoplastic infusion; two carriers

covered antibiotics only as adjuncts to antineoplastic therapy; and the two carriers that covered

hydration did so only for patients already receiving

infusion therapies (365).

The logic behind such coverage is that patients

who are receiving home antineoplastic therapy

should not be forced back into the hospital simply

because of the need for additional related therapies.

The result, however, is that under the present

system, the sickest patients have the greatest

coverage for HDIT, while the healthiest patients

(e.g., needing only simple antibiotic therapy

administered through a gravity drip) usually

must remain hospitalized for the duration of their

therapy.

Impact of Extending Coverage for HDIT

Extending Medicare coverage to include HDIT

would increase the treatment options available to

Medicare beneficiaries and the market possibilities

for HDIT providers. It would also have more

complex potential implications for Medicare expenditures, hospitals who provide inpatient infusion

therapy, and the development of new health care

technologies. These three issues are described below.

Implications for Medicare Expenditures

Whatever its advantages, an HDIT benefit would

almost certainly raise Medicare expenditures in the

first few years of its implementation. The major

reason for this is that Medicare currently pays for

hospital inpatient services on a per-case basis,

according to a patient’s diagnosis-related group

(DRG). This payment system, as it currently stands,

does not permit hospital payments to decrease in a

given year even if more patients are discharged early

to HDIT. In the longer run some offsetting inpatient

savings might occur, as the hospital inpatient

payment rate schedule is recalibrated to account for

the lower hospital costs of serving these patients and

hospital payments are reduced accordingly.

A 1987 study examined some of the potential

effects on Medicare of extending coverage to home

IV antibiotic therapy. This study included 150 home

patients and 144 hospital patients who met the

clinical criteria for home therapy but were treated in

the hospital.24 All home patients had to be able to

self-infuse and had to be well enough to return home

except for the need for continued therapy (e.g., no

fever) (285).

The study found little difference in outcome

between home and hospital therapy. Therapy was

judged successful in 83 percent of home patients and

88 percent of hospital patients. Of patients for whom

data from laboratory and other tests were available,

results were nearly identical for the two settings

(285).

To estimate potential Medicare expenditures, the

study examined 1984 Medicare data on hospitalized

patients in five DRGs that include an estimated

two-thirds of the Medicare patients on long-term

antibiotic therapy.

25 The researchers then simulated

Medicare expenditures under various assumptions

of the extent of home therapy and the ability of

Medicare to adjust hospital inpatient rates.

In the base model, the researchers assumed that at

equilibrium (i.e., several years after implementation

of home IV antibiotic coverage), only 78 percent of

patients would be hospitalized for their entire course

of therapy. Of the remaining 22 percent, 12 percent

would receive some hospitalization (e.g., for the

initiation of therapy), and 10 percent would avoid

24 B~u~e of me ~lc~~ id@@@ eldmly home patients, some patients in the home poup wme under age 65.

n The DRGs examined were those forendocarditis, cdhditis, celhditis with eomorbidities, osteomyelitis, and osteomyelitis with wound debridement.
124 . Home Drug Infusion Therapy Under Medicare

hospitalization entirely. The researchers also assumed that “treatment shifts” from oral to infused

antibiotics would be minimal. Net savings (including savings from fewer physician visits in the home)

were projected to be $16.9 million under baseline

conditions. Changing baseline assumptions to reflect fewer home patients and fewer patients who

could avoid hospitalization entirely reduced, but did

not eliminate, the projected savings (285).

The results of this study imply that, for relatively

independent Medicare patients on antibiotic therapy,

Medicare expenditures would be equal or lower in

the long run if infusion therapy were covered. To

achieve this outcome, however, Medicare must first

withstand greater expenditures in early years (until

hospital payment rates can be readjusted to reflect

the shorter inpatient stays). In addition, there must

be no extra program costs incurred as a result of

inequities among hospitals with differing abilities to

discharge patients early (see below).

One factor not included in this study was dual

coverage-i.e., Medicare beneficiaries who also

have extensive private insurance benefits. Approximately 35 percent of elderly persons26 are covered

by private employer-based health insurance (242).

Although the extent to which these Medicare beneficiaries are currently receiving privately covered

HDIT is unknown, it may be substantial; one

provider, for example, reports that 20 percent of its

privately insured patients (who are 85 percent of

their caseload) are also eligible for Medicare (83).

Any Medicare coverage expansion for HDIT would

probably result in some shift in spending from

private payers to Medicare.

implications for Hospitals

All else equal, implementing an HDIT benefit

should result in reduced average lengths of hospital

stay (ALOS) in the DRGs that include home-treated

patients. The reductions would not apply equally to

all people in those DRGs, however, nor would they

be distributed equally among all hospitals.

Within any individual DRG, the advent of an

HDIT benefit would result in some proportion of

patients being discharged home after a short stay,

while the remaining patients’ stays are unchanged.

Those patients in the first group will have lengths of

stay lower than the average, generally leading to

higher profits for the hospital. Patients in the second

group, however, will often have longer lengths of

stay than the average, and hospitals will lose money

on most of them. Implementing an HDIT benefit

thus would have a natural spiraling effect; as more

patients were discharged early, ALOS in the DRG

would decline, and the remaining sicker patients

would come under ever-increasing pressure to leave

the hospital early.

If there were no counterbalancing pressures or

restrictions, the tendencies of the system could

logically continue the spiral until even the sickest

patients needing continuous care were discharged to

home treatment. Counterbalancing pressures do

exist, of course; they include Medicare payment

restrictions for home care, physician disincentives to

provide home care, home providers’ unwillingness

to accept severely ill patients, and hospitals’ fear of

legal liability for adverse outcomes in severely ill

home patients.

Variability among hospitals’ abilities to discharge

patients to HDIT would prove to be a more serious

and difficult problem to solve. Some hospitals—

those with their own home infusion therapy companies, or with established arrangements with other

providers of such care-are already well-positioned

to take advantage of an HDIT benefit by discharging

as many patients home as possible. Other hospitals

do not yet have such arrangements but can make

them reasonably quickly once a benefit is established. It is likely, however, that a third group of

hospitals also exists: those that cannot discharge

patients home because of the absence of an HDIT

provider in the area they serve, or because the

patients live in homes that are inadequate settings for

such therapy. Furthermore, if these hospitals are

located in very low-income or low-density areas,

there may be little hope of home infusion providers

being established in the future.

Where this is the case, hospitals will be forced to

treat home-eligible patients as inpatients. The more

successful other hospitals are at discharging patients

home, the greater the financial losses of these

hospitals in whom the ALOS remains unchanged

through no fault of their own. The hospitals likely to

suffer the most are those already facing fiscal

M Appro~tely 95 percent of the elderly (age 65 and over) are covered by Mfim.
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare ● 125

difficulties: those that serve primarily rural or poor

populations. 27

For rural hospitals, swing beds may be a solution

for some discharge difficulties related to HDIT.

Medicare permits small rural hospitals to designate

a proportion of their acute-care beds as ‘‘swing

beds” and to receive reimbursement for either

acute-or skilled-nursing-level care provided to patients in those beds. As of 1987, about 1,000

hospitals-roughly half of all eligible hospitals—

had Medicare-certified swing beds (310). In these

hospitals, patients needing only drug infusion therapy could be “discharged’ to long-term care within

the hospital itself and without changing the infusionrelated services provided to the patient. This strategy

might require some guidelines regarding at what

point patients could be “discharged” from acute

care, and it might require some changes in swingbed payment rates, but it would probably relieve

most rural hospitals from the most extreme effects of

having no HDIT provider in their areas.

Urban hospitals serving large numbers of poor

beneficiaries with inadequate homes do not have the

swing-bed option. These hospitals will require

additional payments (e.g., through the disproportionate share adjustment) or other alternative settings to discharge patients (e.g., nursing homes

willing to accept infusion patients) if they are not to

suffer undue losses.

Implications for Technological Change

Unless it is limited to a very few patients,

Medicare coverage of HDIT would affect virtually

every aspect of the home infusion industry. Medicare not only represents an enormous segment of the

user market, but its benefit policies often serve as the

boilerplate for other public and private insurance

programs. In addition, Medicare’s other policies and

the special needs of its population may drive the

market to respond to its own unique characteristics.

Some of the possible areas for technological change

are outlined below.

Development of Drugs and Drug Protocols

Most employer-based insurance policies pay for

oral outpatient prescription drugs (19). At present,

drug development favors oral drugs over other forms

of administration because of their broad patient

acceptance and large market. Developers go to some

lengths to manufacture oral formulations; for example, despite the proven effectiveness of subcutaneous insulin, manufacturers continue to strive for an

effective noninjectable form of the drug (301,303,304).

Medicare, however, does not presently cover most

oral outpatient drugs. If Medicare does begin to pay

for HDIT, it would add substantially to the already

growing demand for parenteral drugs, while the oral

drug market would remain the same. This disparity

in demand by drug type would probably not cause

developers to ignore oral formulations where these

appear easily feasible, but it would make it less

worthwhile to undertake additional research once a

satisfactory parenteral form has been developed.

One possible consequence of this incentive is to

decrease investment in research aimed at oral drug

delivery-the method that is ultimately least expensive for the health care system to deliver.

Medicare HDIT coverage would also probably

fuel the existing trend toward longer, continuous or

intermittent infusions rather than the short, intensive

drug administration that is more suitable to the

hospital. The greater potential market could lead not

only to different protocols for newly developed

parenteral drugs but to new uses of existing drugs

(e.g., broader use of IV immune globulin) (see ch. 2).

Technological Change in Equipment and Supplies

Once a technology of drip bags and simple

peripheral catheters, HDIT now can boast of an

ever-expanding array of medical supplies and devices. Any Medicare coverage expansion is likely to

add to the general incentives to develop new

technologies for the HDIT market. In addition, it

could stimulate technologies aimed more specifically at the special needs of the Medicare population,

within the constraints of Medicare coverage policy.

Many Medicare patients, for example, may not be

able to master or manipulate sophisticated infusion

pumps. The need for simple, easily mastered equipment and supplies among this population is likely to

direct device manufacturers’ resources toward such

areas as one-time, disposable infusion “pumps”;

catheters pretreated with antibiotics to reduce infection; prepackaged and premeasured supplies that

minimize handling needs; and other developments

27 k 1989, sm m~ hospi~ (wi~ fewer k50 beds) and large urban hospitals with a disproportionate number Of pOOr patients had lower toti

hospital fwcial margins than any other hospital types (274).
126. Home Drug Infusion Therapy Under Medicare

that increase supply costs but might reduce the need

for detailed patient training and professional assistance. Alternatively, if Medicare coverage incentives

tended to encourage outpatient rather than home

infusion, manufacturers would probably respond by

developing more devices that could deliver a sophisticated variety of drugs in the home unaided but that

might require intensive nursing attention as often as

once a day.

Issues in Extending Coverage

Making Drug Coverage Decisions

As discussed in chapter 2, many drugs are being

administered safely and effectively at home. However, some drugs are being used for which the

evidence on effectiveness is ambiguous (e.g., dobutamine). Others are effective but may be dangerous

in the home if not closely monitored and administered with proper precautions (e.g., many antineoplastics). Even within categories of relatively safe

drugs there can be drugs that require especially strict

precautions to be administered safely (e.g., the

anti-infective amphotericin B), and drugs that are

extremely costly for the benefit they confer to some

patients (e.g., immune globulin).

Under an HDIT benefit, two basic questions

regarding drug coverage decisionmaking would

arise:

1.

2.

Who should decide what drugs to cover? And

who should decide what limitations to place on

the drugs that are covered?

How should the drug coverage decisions be

made? HOW should the initial set of covered

drugs be determined, and how should future

drugs (or indications for existing drugs) be

incorporated into those decisions?

Policy Under the Medicare Catastrophic

Coverage Act

The MCCA (Public Law 100-360), passed in

1988, would have allowed Medicare to cover drugs

that were safe and effective for IV administration in

the home. The law required coverage for all antibiotics unless the Secretary of Health determined that a

specific antibiotic could not be administered in the

home setting in a safe and effective manner. Drugs

which are not antibiotics were covered only if the

Secretary did determine them to be safe and effective

in the home. The drugs and accompanying diagnoses

for which they were to be covered were published in

the Federal Register in September 1989, just before

the act was repealed. (This notice is reproduced in

appendix C.)

Under the MCCA, Congress took on the responsibility for setting the categories of drugs to be

covered, while delegating the responsibility for

deciding on specific drugs and indications to HCFA.

To produce the list of covered drugs and accompanying indications, HCFA obtained a list of drugs that

were currently approved by the FDA for IV use. This

list was then examined by individuals from HCFA,

with advise from various professional groups and

other sources, to determine the appropriateness of

each particular drug for home infusion (368). Each

drug was evaluated ad hoc and included or excluded

on its own merits; no standardized process for

review was used. Because HCFA has few physicians

or pharmacists on staff, and received little assistance

from FDA clinicians, the evaluators had little

clinical expertise at their disposal.

This system produced a list that was plagued with

seeming inconsistencies. For example, dilantin, an

anticonvulsant agent used to control seizures, was

included on the list of approved drugs despite the

possibility of fatal adverse effects of this drug when

given intravenously (216).28 In contrast, erythromycin, an antibiotic with comparatively minor side

effects, was not included.

The list of conditions for which approved drugs

could be covered showed similar potential inconsistencies. HCFA omitted pulmonary infections from

the list of approved conditions treatable with home

antibiotics, for example, despite the fact that recurrent pulmonary infection related to underlying cystic

fibrosis was one of the first indications for which

home IV drugs were successfully administered

(290).

The list of approved drugs and conditions was to

be updated through a periodic review, with the

timeframe for review unspecified in legislation.

HCFA was prepared to update the list on an annual

or semi-annual basis using a format that was not yet

determined (368). FIs had very little discretion

regarding drug coverage; their main function in this

M ne ~ten~ for the= adve~e effwts me so great that the manufacturer stresses that ‘ ‘continuous monitoring of the electrocardiogram ~d blood

pressure is essential” (216). Practically, this usually means administration of the drag in a hospital intensive care unit.
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare ● 127

regard was to bring new drugs or indications to the

attention of HCFA in order that they be incorporated

to the next update.

Future Policies: Who Should Decide on

Appropriate Drugs?

The final decision of which drugs are approved for

home infusion could theoretically be made at any

point on the regulatory spectrum, from Congress

(through statute) to the individual physician (based

on personal experience and opinion).

Congress could potentially not only establish

categories of drugs to be covered but directly

authorize which drugs and which conditions were

appropriate for HDIT. Setting the drugs to be

covered in statute eliminates ambiguity but makes

updating the list extremely cumbersome. Such a

level of legislative involvement in Medicare coverage decisions is unusual and, given the quantity of

drugs to be considered and the rapidity of technological change in the pharmaceutical industry, probably

undesirable. Congress could, however, set some

general guidelines regarding the relative risks and

benefits that are appropriate for Medicare to underwrite in the home.

HCFA has traditionally undertaken coverage tasks

similar to those involved in HDIT. The list of

procedures that are reimbursable if performed in an

ambulatory surgical center, for example, is established in regulation and has been updated once since

established in 1983 (see 53 F.R. 31468). Under the

MCCA, however, HCFA’s attempt to fill this role

was troubled by a relatively short deadline and a lack

of qualified clinical personnel. HCFA has little

experience in drug evaluation and is not currently

involved in any drug approval process. Requiring

HCFA to approve drugs for home infusion use

means that either HCFA must retain additional

personnel who have detailed knowledge of the risks

and benefits associated with drugs, or that HCFA

must receive assistance from another agency with

such expertise, such as the FDA.

Alternatively, the FDA itself could stipulate what

constitutes safe and effective therapy in the home,

using a similar process to its current approval

process. In effect, this would amount to approval for

labelling the drug for that use. The many drugs not

specifically approved for home use thus could not be

covered.

Fiscal intermediaries could decide what is proper

infusion therapy for home use, making not only

patient-specific decisions on appropriateness but

establishing the general drug coverage categories as

well. Many local medical carriers have already been

involved in this activity to some extent through

making drug decisions as part of the DME benefit,

and some also may perform similar functions for

their private insurance business.

FI-level drug coverage decisions permit relatively

rapid updates to accommodate new therapies. This

flexibility, however, would be purchased at the

expense of some consistency; in contrast to a single

HCFA list, the covered drugs and indications would

probably differ somewhat among carriers depending

on the expertise and practices of providers in their

areas. Some of these differences might be justified;

what can be safely provided at home may well often

depend on provider experience with that drug. Other

difference might be minimized with HCFAmediated communication among carriers.

Finally, coverage could simply be made universally applicable for any drugs that individual physician providers prescribed for use in the home. This

alternative is the most flexible and allows for rapid

incorporation of new drugs and new procedures. On

the other hand, individual provider responsibility for

home infusion would probably result in a tremendous variation of practice which mayor may not be

appropriate to the home setting. This level of

decisionmaking also directly permits payment for

experimental and untested drugs (or existing drugs

being used in novel ways), without making any

provisions that these experimental therapies be

administered as part of an established protocol.

How Should Drug Coverage Decisions Be Made?

The ad hoc decisionmaking under the MCCA

resulted in an irreproducible process that was

heavily susceptible to criticism, and which HCFA

might have been hard-pressed to defend in any legal

challenge. To avoid this problem in the event of a

new benefit, guidelines could be established (e.g., by

Congress or HCFA) that would outline the approval

process and the standard of evidence that a drug

would have to meet to be approved.

Levels of Evidence-Achieving consistency in

drug coverage decisionmaking requires adherence to

an agreed-upon standard of evidence for establishing

the safety and effectiveness of an infused drug in the
128. Home Drug Infusion Therapy Under Medicare

home. This standard would apply regardless of who

actually made the drug-specific coverage decisions.

The most stringent standard would be that required by the FDA for approving the label of any

drugs for marketing. In essence, this standard would

be equivalent to saying that Medicare would pay

only for drugs whose label specified that they were

safe and effective when administration in that form,

for that condition, in the home.

A second level of evidence could require that the

drug be FDA-approved for the condition and that

some data on its use at home be presented. This

approach is entirely feasible, but it prohibits payment for “off-label” use-i.e., use of an FDAapproved drug for an indication not specifically

approved by the FDA for the label. Off-label use is

implicitly reimbursed in hospitalized patients, and a

substantial proportion of the actual use of many

drugs is for off-label use. A recent survey by the

General Accounting Office, for example, found that

nearly half of all cancer patients treated by oncologists receive, as part of their therapy, at least one

drug whose label does not include that particular

type of cancer (354). In the same survey, a number

of oncologists reported having admitted patients to

hospitals solely to have an off-label drug reimbursed

(354). Thus, requiring this level of evidence would

probably affect the actual therapies that physicians

prescribed, and it would probably also result in

fewer patients being treated at home than would

otherwise be the case.

A third level of evidence could be to require that

the drug be FDA-approved and that the particular

indication be listed for that drug in common

reference sources of drug information in order to be

reimbursed. This standard would require less rigorous documentation in supporting the “possible”

effectiveness of a drug and would probably have less

effect on actual prescribing practices than more

stringent standards. There might, however, be some

pressure on the organizations that publish such

reference books to make accommodations to manufacturers in order for a drug to qualify for Medicare

reimbursement.

Finally, the level of evidence required could be

one of a consensus of clinical experts, based on their

personal judgment and knowledge of the literature.

This is a formalized version of the practice of many

local carriers, which use local clinical consultants to

advise them regarding whether a particular procedure, for example, is generally considered safe and

effective (i.e., nonexperimental) (359). This standard would have the least impact on actual prescribing practices but holds the greatest potential for

leading to great variations in coverage decisions

across geographic regions.

Applying Consistent Judgment—Whatever the

stated standard of evidence to which decisionmakers

would adhere, drug coverage decisions would inevitably require judgment on the part of those involved

in the decision. For any given drug, they must decide

whether the risk to patients of delivering a specific

drug in the home is worth the potential benefit. The

fact that a drug is risky does not itself eliminate the

need to make this decision. Even drugs with

unpleasant and sometimes severe side effects (e.g.,

most antineoplastics) are often considered worth

using if the untreated disease is often fatal and there

are few more benign alternatives.

The degree to which an evaluator considers the

level of risk in a drug “acceptable’ is likely to vary

among individuals. Given this, one way to adhere to

a consistent standard of tolerable risk would be to

ensure that the same set of decisionmakers is

responsible for each separate drug coverage decision. Within this group, decisionmakers could make

a conscious attempt to apply individual and group

judgments consistently. Thus, if HCFA were making the coverage decision, applying a consistent

process might mean appointing an outside board of

advisory experts to judge the relative risks and

benefits of various drugs for various indications in

the home. Alternatively, the advisory group might

comprise FDA clinicians, or clinical and other

employees of the Agency for Health Care Policy and

Research. If FIs were to be the decisionmakers, the

clinical advisors to the coverage decision might be

advisory panels composed of local community

physicians, pharmacists, and nurses.

Although clinical experience is not the only

necessary skill to be represented in the group making

the coverage decisions, it is a vital one. Deciding on

an acceptable tolerance of risk requires clinical

input, because it depends on a knowledge of the

alternative treatments for that medical condition.

Since the Medicare population is hugely elderly,

knowledge of the drug’s likely effects in the elderly

population is also a valuable input that requires

clinical experience.
Chapter 6-Covering Home Drug Infusion Therapy: Implications for Medicare . 129

HDIT Eligibility and Home Health Services

Many Medicare beneficiaries who might qualify

medically for HDIT might also need assistive

services-i.e., help with the infusion and any other

needed care-if they were treated at home rather

than in a health care setting. An estimated 40 percent

of elderly persons need assistance with at least one

basic activity of daily living (e.g., eating, dressing)

(see ch. 3). Family caregivers would not necessarily

be available or able to shoulder the burden of

providing assistive health services; of the noninstitutionalized elderly, one-third live alone (386).

Because providing paid assistive health services

increases the payer’s costs of care for a patient on

HDIT, the extent to which Medicare covers these

services for HDIT beneficiaries would greatly affect

Medicare expenditures. One way to affect the

demand for assistive care by HDIT beneficiaries

would be to institute payment mechanisms that

discourage (or encourage) the provision of these

services. Another, more direct alternative would be

to design eligibility and coverage policies for the

HDIT and the home health benefits to affect the use

of such services (or the discharge of patients who

would need such services). Some possible policies,

and their potential implications, are described here.

Atone end of the spectrum, Medicare could cover

HDIT only for patients who can demonstrate the

capacity to administer the infusion without the

assistance of a paid caregiver.29 This alternative

would restrict the benefit to a small number of

patients who were alert and relatively healthy or who

had family or fiends able to perform the administration. In the absence of more information about the

relative costs of home and institutional care, this

alternative offers the surest opportunity to achieve

program cost savings. However, it restricts the

ability of homebound patients, or those who might

be able to avoid hospitalization altogether, to receive

HDIT from a professional caregiver. It would also

eliminate from eligibility for the benefit a large

number of Medicare patients who would prefer to be

treated at home but are unable to take responsibility

for their own care.

At the opposite extreme, Medicare could extend

eligibility for an HDIT benefit to any patient

meeting some basic medical appropriateness criteria

(e.g., the patient requires a parenteral drug and is

medically stable). This criterion would permit the

maximum number of beneficiaries to make use of

the benefit. However, it would permit unlimited use

of assistive home services, no matter how expensive,

unless adjunct policies were also in place to limit

these services.

Policies intermediate to these two extremes also

exist, in which the covered benefits rather than the

eligibility criteria would be restricted. These policies take the form of restricting both the assistive

services covered under the HDIT benefit itself and

the home health care benefits for which the patient

might be concurrently eligible. For example, the

HDIT benefit might include coverage of daily

nursing to accommodate patients with needs for

occasional nurse-administered infusions (e.g., up to

10 visits or 20 hours of home skilled nursing per

week).

This alternative assumes that at some low level of

professional assistance, home care is still less costly

than institutional care. It might be particularly

relevant if relatively low-cost outpatient care or

institutional care in SNFs were not available,

making hospital inpatient care the only real alternative to the home. However, this alternative also

leaves open the possibility that program expenditures may actually increase under this alternative if

the coverage is generous.

To avoid unwittingly paying for assistive services

through the home health benefit in this example,

HDIT patients could be disqualified from concurrent

eligibility for that benefit. Thus, any infusion patient

who also required unrelated skilled nursing care or

other professional therapy or assistive services (e.g.,

physical therapy) could not be discharged home.

This restriction would eliminate the possibility of

paying for home care for patients who need very

extensive services, but it raises the possibility that

many patients might be discharged home and then

rehospitalized (at Medicare’s additional expense) if

they developed a need for occasional additional care.

It might also prevent many terminal or homebound

patients, who currently qualify for home care

services, from receiving their infusion at home as

well. This policy might require that the home

infusion and home health benefits be administered

29 For e=ple, ~ p&&c~mi@t & q~ to ce@ tit ~C patient or family member could perform me infusion as a prerequisite for eligibility

for the benefit.
130. Home Drug Infusion Therapy Under Medicare

by the same FI so that concurrent benefit eligibility

could be detected.

Alternatively, the HDIT benefit could be very

limited in its coverage of assistive services but

beneficiaries could be permitted (if they qualified) to

retain home health benefit eligibility at the same

time. Under this scenario, coverage for concurrent

home health benefits could itself be limited to

restrain utilization of assistive services. For example, HDIT patients who were homebound could be

covered for home health services up to a stated

maximum limit (e.g., 50 percent of the average

per-patient home health payment in that area). This

alternative would allow for some assistance while

providing an incentive for home providers to accept

patients only if their anticipated assistive needs were

few. However, it might also result in some underservice or rehospitalization of patients whose assistive needs were eventually greater than originally

anticipated.
Chapter 7

PAYING FOR HOME DRUG INFUSION

THERAPY UNDER MEDICARE
Contents

Page

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Summary of Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Potential Payment Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Background ..*. *.*. .*. ..*. ... ... o.. ... ..*. . .**. .*** *o*. . **do.....**...**.. 134

Existing Methods of Paying for Drug Infusion Under Medicare . . . . . . . . . . . . . . . . . . . 135

Examples of Potential Payment Models for HDIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Goals and Tradeoffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Cost Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Administrative Feasibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Evaluating Payment Alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Retrospective Charge- or Cost-Based Reimbursement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Competitive Payment Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Noncompetitive Prospectively Set Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Other Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Paying for Drug Infusion Therapy in Skilled Nursing Facilities . . . . . . . . . . . . . . . . . . . . 148

Physician Compensation and Ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Box

Box Page

7-A. HDIT Under Prospective Per Capita Payment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Tables

Table Page

7-1. Medicare Payment Methods for Durable Medical Equipment . . . . . . . . . . . . . . . . . . . 137

7-2. Example of One Insurer’s Prospective Per-Diem Fee Schedule . . . . . . . . . . . . . . . . . . 140

7-3. Presumed Quality Incentives Under Alternative Payment Methods . . . . . . . . . . . . . . . 143
Chapter 7

PAYING FOR HOME DRUG INFUSION THERAPY UNDER MEDICARE

Overview

introduction

The sheer size of Medicare as a purchaser of

health care means that the consequences of its

payment decisions will permeate every aspect of

home drug infusion therapy (HDIT). How the

service is reimbursed will affect the willingness of

providers to offer it, the willingness of physicians

and patients to use it, the content of the care

provided, the setting in which it is offered, the future

structure of the industry, Medicare expenditures,

and, ultimately, health care system costs. The

purpose of this chapter is to briefly describe the

different methods of payment that are possible and

discuss their potential implications if applied to

HDIT.

Summary of Conclusions

There is no single obviously best method by

which to pay for HDIT Three methods, all of

which are currently in use in some form, could

be implemented almost immediately: cost-/

charge-based reimbursement (amplifying on

existing Medicare home benefits and payment

methods); all-cost-based reimbursement; and

prospective, government-set rates per item, per

diem, or possibly per episode of infusion. Two

other possibilities-competitively set rates and

bundling home infusion into hospital inpatient

rates-could be implemented but involve much

greater administrative effort or would require

much more information before implementation.

Of the three payment methods that could be

implemented immediately, cost-/charge-based

reimbursement would be the simplest to implement but offers strong incentives to overprovide care and the fewest possibilities for cost

control. All-cost-based reimbursement offers

incentives to provide high-quality, accessible

care to Medicare beneficiaries, but it also

encourages the provision of costly services and

may be somewhat inflationary. (Placing a cap

on allowable costs might reduce cost increases

to some extent.) Prospectively set rates offer

the greatest possibility for cost control. Pro-

-133-

●

●

●

spective rates for HDIT have been used successfully by private insurers, and more information is available to set rates than was true at

the time the Medicare Catastrophic Coverage

Act (MCCA) was passed. However, this method

could endanger patient access and quality of

care if rates were low and quality of care could

not be monitored adequately.

If prospectively set rates are chosen as the

method of payment for HDIT, bundling at least

nursing and pharmacy services, supplies, and

equipment into a single rate (or set of rates)

might reduce paperwork burdens and system

“gaming.’ ‘ Continual advances in new technology and potential tradeoffs between nursing

needs and equipment costs for some technologies means that, if payment were according to

an itemized fee schedule, Medicare might find

it difficult to keep up with changes in the

therapy and still keep costs under control.

Some private insurers have successfully implemented HDIT “preferred provider’ programs,

under which providers agree to meet quality

standards and accept the insurer’s payment rate

as payment in full, in exchange for the likelihood that more of that insurer’s patients will

use the provider’s services. A similar program

requiring mandatory assignment for HDIT

providers serving Medicare patients would

reduce patients’ risk of being billed for charges

in excess of the Medicare payment rate. A lack

of providers willing to participate would be one

indicator that Medicare payment rates were set

too low.

Good-quality HDIT requires intimate physician involvement. Paying physicians for this

involvement would enhance quality of care and

remove existing physician incentives to either

avoid HDIT or receive “consulting fees’ and

other remuneration from HDIT providers. To

control costs and prevent physician “unbundling’

of services for billing purposes, Medicare could

pay a single rate for physician services related

to a single specified period of time (e.g., per

day, per week, or per episode of infusion

therapy). Separate provisions could be made for

patients on indefinite or multiple therapies.
134 ● Home Drug Infusion Therapy Under Medicare

●

●

Many patients who could be served with HDIT

might be equally well or better served by

infusion therapy provided in a skilled nursing

facility (SNF) or an outpatient facility. Payment for infusion therapy in these settings

deserves study and possible revision concomitantly with consideration of payment for HDIT.

In particular, higher payment for infusion

provided in SNFs may be warranted where it

can be provided with good quality in this

setting. Similarly, rural swing-bed patients on

drug infusion therapy should receive adequate

reimbursement, particularly when the hospitals

are unable to discharge patients due to a lack of

quali.tied HDIT providers.

Physician ownership of drug infusion facilities

presents some troubling issues. Physicians are

the critical source of referrals for HDIT providers, and physician ownership of a provider may

inhibit referrals to other providers even if those

providers offer care of equally high quality and

lower cost. For some physicians, office-based

infusion-in which the actual drug infusion is

performed in the physician’s office-is a direct

extension of the physician’s usual practice.

Although this also represents a “captured”

referral, it raises slightly different issues than

physician co-ownership of other outpatient and

home infusion companies.

Potential Payment Methods

Background

Two basic payment methods are used to pay for

health care services: retrospective methods, in

which the amount of payment is determined after the

services have been provided; and prospective methods, in which the rate is set before the visitor service

actually takes place.

Retrospective Methods

Retrospective cost- and charge-based payment

methods were the original mainstays of Medicare

payment to health care providers. Hospitals, for

example, were originally reimbursed based on their

actual allowable costs of serving Medicare patients

(359). Most home health services continue to be

reimbursed by Medicare in this way (although there

are limits on the amount paid). Charges (rather than

costs) were the historical basis for paying physicians

and for reimbursing for such items as laboratory tests

and home durable medical equipment (DME) (359,

360).

Retrospective cost-based payment creates some

strong financial incentives for providers. First, since

such methods usually allow for recovery of full

average costs, including a return on capital investment, providers with marginal costs that are lower

than average costs make a profit on each service

provided. 1 Thus, they have an incentive to serve as

many patients as possible. Second, for each individual patient, providers have an incentive to offer as

many services as possible (including services that

provide little real benefit to the patient). Third, there

is little incentive for providers to produce services

efficiently, since they can recover any expenses

related to production. And fourth, where cost-based

payment exists side-by-side with other payment

methods, providers are encouraged to use whatever

accounting flexibility they have available to attribute costs to the cost-reimbursed service.

Cost-based payment can lead to poor-quality care

if unneeded services (with their attendant risks,

however minor) are provided. However, it can also

lead to high-quality care if providers choose to

compete on the basis of quality (since competing on

the basis of cost confers no advantage under this

method).

Where actual costs are difficult to determine,

historically Medicare has paid on the basis of

charges. Like cost-based payment, retrospective

charge-based payment contains incentives to increase the number of services as long as the charges

for the service are higher than the costs of providing

the service (as, presumably, they usually are). And,

like costs, charges as the basis of payment tend to be

inherently inflationary, since there are few incentives for providers to reduce them. Because charges

are limited only by the competitiveness of the

marketplace and what providers deem appropriate to

bill, Medicare now pays for few services at their

actual or average charge. However, many items and

services are currently reimbursed at set rates according to a fee schedule, and the level of (and variation

among) rates can often be traced to the average

charges that served as the original basis for the fee

schedule.

1 See p. 196 for deftitions and a discussion of marginal and average costs.
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare . 135

Prospective Methods

In contrast to retrospective methods, prospective

payment involves determiningg payment rates in

advance of service delivery. Because payment is

unchanged by the actual costs of producing that

particular service, providers have an incentive to

reduce costs. Providers may also have an incentive

to reduce service quality as a way to reduce costs

unless there are counterbalancing forces (e.g., competition for referrals or regulatory penalties). Thus,

use of such methods may require enhanced levels of

quality monitoring and assurance. Difficulties in

updating prospective rates can also present problems. Fixed-rate schedules may be less responsive

than competitive approaches to changes overtime in

technology and production processes.

The effect of a given prospectively fried rate

schedule depends on such factors as the level of the

rates and the base units to which the rates apply.

Very high rates encourage inefficient production of

services; very low rates may discourage providers

from participating in Medicare or offering the

service at all. Rates applied to a very detailed level

of service (e.g., a single visitor piece of equipment)

may offer different incentives to under- or overprovide these services than rates that apply to a bundle

of services (e.g., all services provided on a given

day).

Prospective rates may be freed in advance by the

payer and applied equally to all providers with little

direct provider input (e.g., fee schedules determined

by past charges). Alternatively, they can be set

through competitive bidding or negotiation with

providers. For example, the payer may advertise a

contract for providing a certain service to patients

and contract with the provider(s) offering the lowest

price for that service. Or, the payer may enter into

direct negotiations with providers, with different

providers receiving different rates. Such payment

methods have been employed by the Department of

Veterans Affairs and some Medicaid programs for

purchasing home oxygen and other home medical

equipment items (82).

These options avoid some of the difficulty the

payer may otherwise face in determiningg what an

appropriate rate should be, since in this case market

forces determine the payment rate. In order for a

competitive bidding-based system to be effective,

however, there must be sufficient market competition to ensure that all the bids will not be artificially

high. The service must also be sufficiently welldefined to enable it to be specified exactly in the

contract or negotiation process.

Establishing market-based prospective rates may

be a time-consuming and expensive process, particularly if it requires individual negotiation with many

providers. In addition, this method raises the same

need for quality assurance activities as other prospective freed-rate methods.

Existing Methods of Paying for Drug Infusion

Under Medicare

Hospital Inpatient Infusion

Drug infusion therapy provided to hospital inpatients is reimbursed through Medicare’s hospital

prospective payment system, in which rates for the

coming year are set prospectively for each diagnosisrelated group (DRG). Hospitals do not receive

payment specifically for the infusion supplies and

services or associated laboratory tests. Rather, those

costs are lumped with all other costs of treating

patients in each DRG, and the payment for that DRG

is assumed to cover the average costs of all patients

it comprises. Hospitals that can reduce the costs of

treating any one individual (e.g., by using a less

expensive drug, reducing the nursing visits necessary, or discharging a patient early) will maximize

their profit (or minimize their loss) on that individual.

In certain DRGs (e.g., the one that includes

osteomyelitis), patients receiving long-term drug

infusion make up a substantial proportion of all

patients (285). The costs of infusion therapy in these

DRGs is thus a signifcant proportion of total costs,

and changes in the amount of inpatient infusion

would have a major effect on the future reimbursement for all patients in these DRGs. In contrast, in

DRGs for which drug infusion is an infrequent

treatment, or limited to patients with very short-term

needs, discharging patients who are on long-term

infusion would have little effect on future inpatient

payment rates.

Nonetheless, because hospitals receive the same

per-patient payment regardless of whether the patient is discharged early or remains in the hospital,

hospitals have a strong incentive to transfer longterm infusion patients to other settings as rapidly as

possible. This incentive is unchanged by future

lower payment rates in high-infusion DRGs; hospi-
136. Home Drug Infusion Therapy Under Medicare

tals still reduce their costs by discharging infusion

patients as early as they can.

Infusion in Other Facilities

Outpatient Facilities--Medicare payment for

outpatient drug infusion depends on the setting in

which it takes place. If the setting is a hospital

outpatient department, infusion is reimbursed retrospectively on a cost basis (i.e., based on Medicare’s

share of hospital costs actually incurred) for drugs,

services, and most supplies and equipment. If the

setting is a physician’s office, reimbursement is

retrospective and based on the physician’s charges,

within the limits of what Medicare allows. (Beginning in 1992, Medicare is phasing a fee schedule for

physician services, but it is not yet clear how this

will affect office-based infusion services.) In both

cases, providing more infusion results in more

reimbursement to the facility (or physician).

Skilled Nursing Facilities--Drug infusion in

SNFs is covered under the usual prospectively set

daily SNF rate and paid under Medicare Part A.

Hence, these facilities incur costs but receive no

more reimbursement in the short run when infusion

therapy is provided. (In the long run, as with

hospitals, incurring infusion costs in one year may

raise reimbursements in future years, but the return

is not directly related to the service provision for that

individual patient.)

Ancillary Services-For all nonhospital infusion, related laboratory tests are reimbursed separately. Medicare pays the clinical laboratory directly

on the basis of a fee schedule that is limited by a

national cap on maximum fees for specific services.

Medicare pays a separate nominal fee (up to $5) to

cover the costs of specimen collection when skilled

personnel are necessary (e.g., to perform a venipuncture). For beneficiaries who are homebound or who

are inpatients of a nonhospital inpatient facility,

Medicare also pays the transportation costs of

skilled personnel who travel to the patient’s residence to collect such specimens (SSA sec. 1833(h)).

Home Infusion

In the home, unlike other settings, the supplies

and services that make up drug infusion therapy are

generally reimbursed independently in different

ways. In addition, drugs are only occasionally

directly reimbursed by Medicare. (Physician services and laboratory tests are separately reimbursed,

as they would be for any other nonhospital service.)

Equipment-Medicare payment for medical equipment (e.g., infusion pumps, IV poles) and related

supplies under the Part B DME benefit is retrospective, based on the lower of the actual charge or a

local fee schedule amount (SSA sec. 1834). A

separate fee schedule is established for each of six

categories of DME (table 7-l).

Fee schedule amounts were initially determined

by carriers (the Part B fiscal intermediaries, or FIs)

based on local charges for the equipment and have

been updated by inflation. The Omnibus Budget

Reconciliation Act of 1990 (Public Law 101-509)

mandated a transition to a national rather than local

fee schedules for DME, to be fully implemented by

1993.

Home Health Services-Services provided by a

home health agency (ID-IA) are reimbursed on the

basis of retrospective costs. The computed reasonable cost per visit is subject to nationally applied

limits for each type of service2 for freestanding

HHAs.3 Hospital-based HHAs are permitted higher

limits to account for presumed higher administrative

and general costs.

For the purposes of reimbursement, the provision

of any of the covered home health services by a

particular skilled nurse, skilled therapist, or home

health aide on a particular day or at a particular time

of day is considered a visit. For example, a registered

nurse and a physical therapist providing services on

the same day would be considered two visits. Two

separate visits by a nurse on the same day would also

be considered two visits, but if a nurse performs two

separate services during the same visit (e.g., skilled

nursing services and home health aide services) it is

covered only as a single visit.

2

‘IjqMs of services are skilled nursing care, physical therapy, speech pathology, occupational therapy, medical social services, and home health aide

services.

s Although calculated by service, limits are actually applied in the aggregate, permitting HHAs to offset high-cost services with low-cost services

(353). A recent study by the General Accounting OffIce concluded that cost savings are greater when limits are applied by type of visit rather thaQ in

the aggregate, and that the impact on beneficiary access and quality of care would be minimal if HCFA applied limits by type of visit (353).
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare . 137

Table 7-l—Medicare Payment Methods for Durable Medical Equipment (DME)

Category Payment method

Inexpensive rental payments or routinely

purchased DME . . . . . . . . . . . . . . . . . . . . . . . Lump-sum purchase amount or monthly rental payments whose total may not exceed

the lump-sum amount.

Items requiring frequent or substantial

servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monthly rental until the period of medical necessity ends.

Customized items adapted for a particular

patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lump-sum purchase amount determined by the carrier with consideration as to the

equipment’s maintenance and servicing needs.

Prosthetic and orthotic devices. . . . . . . . . . . . . Lump-sum purchase amount for most prosthetic and orthotic devices. Intraocular

lenses; parenteral and enteral nutrition nutrients, supplies, and equipment; and

prosthetic devices that fall into other Medicare coverage categories (e.g., artificial

limbs) are exceptions that are subject to different rules.

Capped rental items . . . . . . . . . . . . . . . . . . . . . . Monthly rental amount that is at the lesser of the actual charge or 10 percent of the fee

schedule amount for the equipment. Payment may not exceed 15 continuous

months of equipment rental. Suppliers must continue supplying rented DME at no

additional charge to the beneficiary after Medicare payments have stopped,

provided that such rental continues to be medically necessary. Maintenance and

servicing fees are calculated separately on a reasonable charge basis for each

item.

Oxygen and oxygen equipment . . . . . . . . . . . . Monthly rental according to a fee schedule specific to the type of equipment.

SOURCE: Office of Technology Assessment. Information from Social Security Act, section 1324 (a).

Drugs-Drugs are rarely explicitly covered in the

home. The single exception is for certain drugs that

are covered under the DME benefit (as part of an

fusion pump; see ch. 6). In these cases, Medicare

usually pays for the drug based on either historical

charges for that drug code for a given carrier or the

listed average wholesale price (AWP) of the drug.

Occasionally, the drug is simply included in the

payment for the infusion pump (365).

With exception of DME-basedpayment, payment

for the drug to be infused must come either directly

from the patient, from the providing pharmacy (as

charity care), or from another interested provider.

Specifically, a hospital may choose to pay for the

drug (or donate the drug) in order to discharge a

Medicare patient from the hospital and reduce

inpatient costs while retaining the full inpatient

payment. Anecdotal accounts of this practice are

widespread, but there are no data on the frequency

with which it occurs.

Hospice Services

Medicare pays for hospice-related infusion services under the prospective fee schedule for hospice

services. Each day of hospice care is classified into

one of four ‘levels of care. ’ Medicare pays hospice

programs at a per diem or an hourly rate, depending

on the level of care to which that day is assigned.

Including infusion services does not change the

daily payment. The four levels of care are:

●

●

●

●

routine (periodic) home care;

continuous home care (at least 8 hours of home

hospice care per day);

general inpatient care (for symptom management or pain control that cannot be provided in

the home setting); and

inpatient respite care for up to 5 days (to

provide respite for family caregivers) (74).

Payment for all hospice services is subject to a cap

on total payment per patient (74). The only covered

services not included in the prospective rates are the

direct patient care services of physicians. For

physicians employed or paid by the hospice, direct

patient care services are reimbursed on the basis of

charges for those services. The services of other

physicians are paid through Part B in the same way

as nonhospice physician services.4

A pa~ents to hospice physici~ are made in addition to the daily rates but are counted toward the overall cap on per patient hospice payment. pm

B payment for physician services is not counted toward the overall cap (74).

297-913 0 - 92 - 10
138. Home Drug Infusion Therapy Under Medicare

Examples of Potential Payment Models

for HDIT

Unbundled Retrospective Payment: The Existing

Medicare Home Benefit Model

Medicare’s existing payment methods for home

nursing and equipment offer the most basic model

for an HDIT payment method. Under this model, the

different components of HDIT would be paid

separately in the same way they are under existing

benefits. Equipment and supplies would be reimbursed according to the present method of paying for

DME and related supplies; payment could be made

either to an HHA or directly to the DME supplier.

Infusion-related nursing services would be paid on

the basis of visit costs under the HHA methodology.

Physician services and laboratory services would be

reimbursed in the same manner as at present.

Drug payment has less precedent under the

current system. Most carriers pay based on their own

charge experience, but the drug codes in the

Medicare coding system are crude and often inadequate (365). Pharmacy services are not explicitly

recognized.

At present, the only well-developed payment

model for home-infused products and related pharmacy services is the existing method of paying for

home total parenteral nutrition (TPN).5 Under the

Part B prosthetic device benefit, payment for nutrients administered in the patient’s home is based on

the reasonable charge for the various solution

components provided to the patient (379). The

charge for the nutrients implicitly includes payment

for related pharmacy services, since these services

are not recognized separately. All TPN bills are

processed and paid by two regional carriers to ensure

consistency in coverage and payment policies. At

the least, extending the TPN payment model (or

almost any other payment model) to drugs requires

the development of much more detailed drug codes.

Prospective Payment for Bundled Services:

The ESRD Model

Like drug infusion therapy, dialysis for patients

with end-stage renal disease (ESRD) can be provided at home and involves a sophisticated mix of

medical equipment, supplies, and services. Existing

payment methods for chronic dialysis thus are

potentially applicable to HDIT as well.

Medicare pays for medical care associated with

home dialysis in one of two ways:

Method l—If a home dialysis patient receives

care from an approved dialysis facility, Medicare pays that facility a monthly rate that

includes all services, supplies, equipment, and

certain laboratory tests associated with dialysis. Separate monthly rates apply to continuous

cycling peritoneal dialysis and intermittent

dialysis (379). Claims are processed by the

Medicare Part A intermediary.

Method 2—If a home dialysis patient obtains

supplies, equipment, and services directly from

the supplier, Medicare pays the beneficiary (or

the supplier) its share of the reasonable cost of

these items. Payment is per item, but total

monthly payments for all items may not exceed

the applicable composite rates under method 1

(Public Law 100-239). Claims are processed by

the Medicare Part B carrier.

The vast majority of Medicare home dialysis

patients are covered under the method 1 composite

rate (74). The new cap on method 2 payments has

been difficult to implement in some areas because

supplies are not billed locally (e.g., a patient on

home dialysis in South Carolina may receive equipment from a supplier in Georgia) (45).

Laboratory tests not included in the method 1

composite rate are paid as any other Part B

diagnostic laboratory services under fee schedule for

those services (379).

All physician’s services that are related to the

continued management of a home dialysis patient

are reimbursed by the carrier under a separate

monthly cavitation payment (MCP). The amount of

the MCP is based on local prevailing charges for

medical specialists’ followup office visits in 1981,

as periodically updated since. In 1988, the MCP for

any given locality was subject to a minimum of $132

and a maximum of $203. Services unrelated to

dialysis management may be billed separately from

the MCP. Payment for self-dialysis training services

provided by a physician is also made separately from

5 There is currently no written policy for TPN paymen~ although the carriers have special instructions from the Health Care Financing Adnums “ “ tration

(HCFA). The OffIce of ‘Ib&nology Assessment (OTA) obtained information about coverage and payment directly from HCl?A’s Bureau of Program

operations.
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare . 139

the MCP amount (at a flat rate of $500 per patient)

(379).

Were infusion drug therapy to be paid according

to the ESRD model, reimbursement would be made

at one or more flat rates per patient, with the rates

including equipment, supplies, and services. The

drugs themselves could be either included or excluded in the composite rate, as could laboratory and

physician services. The ESRD program also provides a possible model for paying for infusionrelated physician services.

Prospective Rates With Participation:

The Blue Cross/Blue Shield Model

A number of private insurance companies have

instituted HDIT benefits (55), and models from

these companies may be applicable to Medicare.

Some insurers have instituted benefits paid in a

manner similar to the “existing home benefit”

model described above; each component is paid

based on costs or charges according to preexisting

benefit policies (55). Other insurers, however, report

satisfaction with a payment model that combines a

prospectively set per-service or per-diem rate with a

process under which eligible providers agree to

become preferred providers if they accept that rate.

In the preferred provider model (used by at least

three Blue Cross/Blue Shield plans), the insurer

defines some provider conditions of participation

and offers a set of rates for a defined set of HDIT

services. Area providers that meet the conditions of

participation can agree to serve the insurer’s patients

at the set rates. In doing so, they agree to “accept

assignment’ and accept the rate as payment in full.

Providers who agree to participate are “preferred

providers ‘‘ in the program; physicians are encouraged to refer patients to them, and patients are

encouraged to use them to avoid extra billing.

Nonparticipating providers may also serve patients,

but they are paid only the set rate and the patient is

liable for any additional billed amount (43,243).

To be successful, the preferred provider model for

HDIT requires four elements:

●

●

●

a well-defined set of services to be provided,

minimum quality standards for chosen providers,

a rate that is high enough to cover necessary

provider costs but lower than at least some

billed charges on the market, and

. enough providers in the market to invite competition for patients.

The rate is especially critical. If it is too high, the

payer loses the advantage of market leverage and

makes unnecessary payments. If the rate is too low,

providers will be unwilling to participate because

they cannot cover their costs; too few providers

mean impaired access for patients.

Two insurers in Arizona and Washington, DC that

use this model set rates and pay in slightly different

ways. In Washington, DC, infused drugs are paid at

a set amount over the listed AWP, based on

pharmacist input regarding the preparation time

needed for different drugs (43). Equipment is paid

according to a rental fee schedule. All other supplies

and services (except laboratory and physician services) are “bundled” and paid at a daily rate that

varies depending on the amount of nursing services

needed that day (table 7-2). The daily rates were

calculated from an amalgam of historical charges,

manufacturers’ list prices, and professional input

(43).

In Arizona, in contrast, rates are established

separately for each individual item, whether it be

equipment, supplies, or services. Drugs are paid at

AWP plus an administrative markup; pharmacy

services are paid per dose, based on judgments of a

pharmacist panel (243).

Both of these insurers report lower costs than

before instituting their respective programs, when

they were paying much higher billed charges. Both

also report substantial participation rates among area

providers, at least in the brief time they have

operated thus far (43,243).

The Medicare Catastrophic Coverage Act Model

After the MCCA was passed, the Health Care

Financing Administration (HCFA) published proposed regulations that outlined in detail how the

home intravenous (IV) drug therapy benefit under

that act was to be paid (see app. C for a summary of

the proposed regulations). Although they were never

made final due to the repeal of the act, these

proposed regulations offer a detailed potential model

for any future similar benefit. In them, HCFA

proposed to pay for home IV drug therapy in two

parts: 1) the drugs, and 2) all other supplies,

equipment, and administrative, pharmacy, and nursing services.
140. Home Drug Infusion Therapy Under Medicare

Table 7-2—Example of One Insurer’s Prospective

Per-Diem Fee Schedulea

Payment

Description per day

Medical suppliesb and nurslng services

Initial home nursing visit for instruction and

assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Supplies only (no professional nursing intervention);

patient is self-administering medication. . . . . . . . .

Supplies and brief (O to 1 hour) professional nursing

intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Supplies and intermediate (more than 1 to 2 hours)

professional nursing intervention . . . . . . . . . . . . . .

Supplies and comprehensive professional nursing

intervention (more than 2 hours) . . . . . . . . . . . . . . .

Additional medical supplies for multiple therapies

(billed in addition to one of above services) . . . . . .

Noninfusion maintenance of central line catheter

(implantable device) . . . . . . . . . . . . . . . . . . . . . . . .

Noninfusion maintenance of central line catheter

(nonimplantable device) . . . . . . . . . . . . . . . . . . . . . .

Blood transfusion and associated nursing visits

(per episode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Equipment rental

IV pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

External ambulatory infusion pump and

administration equipment. . . . . . . . . . . . . . . . . . . .

Stationary infusion pump. . . . . . . . . . . . . . . . . . . . . . .

Patient-controlled analgesia infusion pump . . . . . . . .

Elastomeric infuser . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$200.00

35.00

110.00

160.00

345.00

25.00

30.00

5.00

475.00

1.00

19.00

12.00

16.00

30.00

~his table represents only part of the fee schedule. It does not include

items on the fee schedule that relate to nutritional therapy, aerosolized

therapy, or other services.

bFee a=um= supplies are distributed by the home care protider.

SOURCE: L. Bodenheimer, Blue Cross and Blue Shield of the Nationai

Capital Area, Washington, DC, personal communication, June

28, 1991.

The drugs themselves were to be subject to a

payment rate that depended on the exact drug and

dosage. The rate for a given drug was the lesser of the

actual charge or the calculated payment limit. The

payment limit, in turn, was based on a per-dose

average price for the drug, derived from published

AWPs or HCFA-conducted surveys of drug prices.

The payment limit also included a small administrative allowance for each dose (54 F.R. 37208).

All other supplies, equipment, and services were

to be included in two per diem rates, one for each

general type of covered therapy (i.e., antibiotics and

analgesics). Rates were built up through estimates of

the cost of providing each of the components of the

pharmacy and nursing services and supplies required. Establishing these rates required not only

information on per-unit costs but on assumptions

regarding the services required. A patient on antibiotic therapy, for example, was assumed (on average)

to require a nursing visit and associated catheter

supplies every 3 days, drug delivery every 5 days,

and self-administration of one dose (with associated

per-dose pharmacy preparation time) 2.5 times each

day. Only 10 percent of antibiotic patients were

assumed to require pumps (54 F.R. 46938).

The proposed basic fee for pain management

therapy (not including the drug) was $31.63 per day,

and the basic daily fee for antibiotic drug therapy

was to be $45.44. These amounts would be adjusted

for geographic variation in a wage index and would

be reviewed for updating overtime (54 F.R. 46938).

In addition, providers would receive one-time or

patient-specific allowances for initial patient education and treatment and for patients on multiple drug

regimens. Physician and laboratory services were

outside the fee schedule and would be paid as any

other such services.

Bundling With Hospital Services:

A Hypothetical Model

Linking post-hospital and hospital treatments into

a single payment for all nonphysician services has

never been implemented under the Medicare program, but the idea is not entirely new. In fact,

combining hospital and post-hospital home health

services was one of the potential payment methods

that HCFA considered testing in a demonstration

project in the 1980s (381).

In the context of HDIT, bundling with hospital

inpatient payment could take two forms. First, the

costs of paying for HDIT could actually be included

in the prospective payment rate to hospitals for

relevant DRGs. In essence, the costs of post-hospital

infusion therapy would become for Medicare purposes part of hospital costs, and the calculations of

DRG payment rates would simply be adjusted to

account for them. All hospitals would receive the

new DRG rate, regardless of their actual institutionspecific patient experience.

Alternatively, all hospitals could receive the basic

DRG payment (which might be lower than at

present), and hospitals would receive an additional

add-on payment for each patient discharged to

HDIT. The add-on would be assumed to cover all

costs of the home therapy (except physician services).
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare . 141

In either case, the essential feature is that the

hospital receives the payment for the home therapy.

Thus, the hospital must either provide the therapy

itself (e.g., through its own HDIT service), or pay in

turn the outside provider who does so. Bundling

HDIT and hospital payment would have the great

advantages of reducing hospital incentives for overly

early discharge of patients requiring detailed care,

while encouraging hospitals to use the most costeffective setting for patients appropriately discharged to nonhospital infusion. There would be

strong incentives to control costs, including limiting

the duration of treatment, as payment would essentially be on a per-episode basis.

However, this method would also face substantial

implementation difficulties. To correctly update the

hospital payment rate, or calculate the add-on rate,

the average costs of home infusion patients associated with each DRG would have to be determined.

Doing so would be very difficult, since outside

providers have little incentive to make their perDRG costs known even if they know them themselves. Also, this payment method requires that

hospitals have sophisticated and ongoing relationships with outside home providers, which would

take some time to develop. Fewer than 20 percent of

current HDIT providers are hospitals (193). Hospitals unable to provide such services directly would

need to solicit bids for such services, much as would

be the case with a public-sector agency responsible

for a competitive-bidding-based payment system.

Furthermore, a significant and probably increasing proportion of HDIT patients are not hospital

inpatients at the time they begin therapy. Individual

HDIT providers report that anywhere between O and

23 percent of their patients begin their home

infusions in outpatient settings (195,250,332), and

one provider reports that the proportion increased

from O in 1986 to 20 percent in 1989 (83). Separate

payment methods would still be required for these

patients.

Another “bundled service” model would be to

pay for all HDIT services through HHAs. Under this

model, an HHA providing home health services to a

Medicare patient who also required HDIT would

receive an add-on for supplies and services directly

related to the infusion. Services and supplies by

patients needing only infusion, and no other, home

health services would be paid to the HHA at some

prospective rate slightly higher than the add-on rate.

Box 7-A—HDIT Under Prospective

Per Capita Payment

The most comprehensive “bundle” of services

to which a prospective rate may be applied is the

universe of health care services an individual needs

during a given time period--"per capita” payment.

Here, a provider receives a predetermined fee per

year for every beneficiary enrolled with that provider, regardless of whether the beneficiary actually

uses any services. Payment includes not only

infusion therapy but all other acute and primary care

(and, sometimes, some long-term care as well).

This model is already in place for Medicare

beneficiaries enrolled in health maintenance organizations (HMOs), which receive a capitated rate that

includes all the Medicare benefits to which a patient

is entitled. In essence, for HMOs, payment for

HDIT is “bundled” with payment for all other

health care services.

Some HMOs provide HDIT themselves for those

beneficiaries they deem eligible (389); others contract with outside providers who offer the service.

The outside providers, in turn, may accept either

fees-for-service or a capitated rate for the patient

pool, with the exact number of patients they will

serve unknown at the time the rate is set (186). In

contrast to per capita payment for all basic health

services, there is very little experience yet with per

capita payment to HDIT providers to cover only this

therapy.

The advantages of this model relate less to

cost-effectiveness incentives than to care coordination incentives; patients needing both infusion and

other home health services would have care coordinated within a single provider. Like the hospital

bundling model, this model has the disadvantage

that it requires agencies that do not provide infusion

in-house to have arrangements with other providers.

This disadvantage is not be trivial; at present, it

appears that many HHAs have little direct experience with HDIT.

Goals and Tradeoffs

Any payment method is a compromise to achieve

the best result given a number of competing goals.

Among the major goals of the Medicare system are:

● Access to necessary medical care for Medicare

beneficiaries. This goal can be achieved only if

payments to providers are adequate to induce
142. Home Drug Infusion Therapy Under Medicare

●

●

●

sufficient supply to serve Medicare beneficiaries.

Care of acceptable quality for beneficiaries. To

ensure care of at least minimum quality,

Medicare may provide incentives for providers

to produce care of high quality (e.g., by giving

higher payments or conferring a market advantage to high-quality providers). Alternatively,

Medicare may implement quality monitoring

and assurance systems, under which payment is

denied when certain indicators fall below

acceptable standards.

Equitable treatment of beneficiaries, providers,

and other participants in the health care system.

For beneficiaries, the goal is equity of access

and cost burdens; for providers, the goal is fair

payment and participation rules.

Cost controls that keep program, beneficiary,

and health system costs as low as possible.

Because cost control competes directly with

other objectives, payment systems are usually

designed to achieve appropriate levels of cost,

consistent with other goals, rather than to

achieve the minimum possible costs.

An administratively feasible program that can

be implemented. To be successful a payment

method must be workable for both government

administrators and for providers. Some programs may be very complex and costly to

administer; for others, the information base

needed to implement the program (e.g., to

determine appropriate payment rates) may be

lacking. Programs may also differ in their

acceptability to providers and the costs of

overcoming poor provider participation.

These policy goals are not entirely distinct from

one another. Administrative feasibility, for example,

could be considered a subset of program costs.

Focusing on each separately, however, highlights

the tradeoffs between goals that are inherent to the

different basic payment methods.

Access

Access to care for beneficiaries requires providers

who are willing and able to provide care. Sometimes,

access is endangered because no providers exist—

for example, in a rural area with insufficient

population density to support a home infusion

provider. In other cases, providers may exist but may

be unwilling to serve Medicare patients. Because

willingness to serve patients is often related to

reimbursement for services, Medicare must trade off

the desire for program cost control with the need to

ensure the participation of adequate numbers of

providers in every service area.

For Medicare home health services, which are

reimbursed on a cost basis, provider participation

has not been a problem. Nonetheless, provider

participation could become an important issue if

Medicare adopted a fee schedule that providers

found inadequate. It has been documented that

physician participation in the Medicaid program is

directly related to rates paid (143,152,313). In some

areas, physician willingness to accept assignment

(which implies acceptance of Medicare’s payment

rate) for Medicare patients has also been an issue

(56,180,214). The consensus of research in the past

has been that an increase in payment rates (relative

to physician charges) would increase physician

willingness to accept Medicare assignment (56,

221,255).

If providers cannot control the payment they

receive for services, they can still to some degree

control the types of patients they serve. Nursing

homes, for example, have been thought to select

patients requiring the least costly care in order to

maximize profits under a fixed-rate payment system

(173). HHAs, currently reimbursed for their costs,

have little reason to be selective in serving patients

(though they may try to avoid or terminate particularly troublesome patients who exact an emotional

cost on staff that is not reimbursable). A freed-rate

payment scheme, however, could create incentives

for HHAs to find ways to serve the less costly

patients. This might be accomplished through establishing outreach and referral networks directed

toward low-cost patients, or by encouraging the

transfer of costly patients to other providers.

The payment rate necessary to induce a sufficient

number of providers to offer their services to

Medicare patients may vary among geographic

locations and according to local market conditions.

If access is to be ensured for all, it may be necessary

to tailor rates to market area characteristics. Or, if

uniform rates were to be used, Medicare could allow

rates that are higher than necessary in low-cost areas

to ensure adequate supply in high-cost areas.
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare ● 143

Table 7-3-Presumed Quality Incentives Under Alternative Payment Methods (relative to cost-based reimbursement)

Provider incentives relating to:

Visits

Cost per per time Length of Potential impacts on

Payment method visit period episode quality of care

Rate per visit. . . . . . . . . . . . . . . . . . .

Comprehensive monthly rate . . . . . .

Comprehensive per-episode rate. . .

Bundling payment for hospital and

posthospital services . . . . . . . . . .

Competitive bidding . . . . . . . . . . . . .

Reduce Reduce increase ●

Reduce Reduce increase ●

●

Reduce Reduce Reduce ●

●

●

Reduce Reduce Provide cost-efficient ●

balance of hospital and ●

posthospital services

●

Reduce length of visitor quality of staff

Reduce length of visit or quality of staff

Provide service too infrequently

Reduce length of visit or quality of staff

Provide too few home health services

Discharge prematurely

Reduce length of visit or quality of staff

Provide too few hospital/posthospital

services

Discharge prematurely

Same as above units of payment for any given type of rate, but incentives maybe intensified if rates

based on bidding are lower than rates based on historical costs. Also, possible reduction in access

to services if winning bidders have insufficient capacity and/or losing bidders serve areas not reached

by winning bidders.

SOURCE: U.S. Department of Health and Human Serviees, Health Care Financing Administration, Office of Research and Demonstrations, Demonstrations

and Designs of A/temative F?eimbursement Methods for Home Hea/th Sem”ces, HCFA Pub. No. 03290 (Baltimore, MD: HCFA, September 1989),

table 3-2.

Quality Assurance

The quality and quantity of care provided to

patients receiving home health services can be

affected by the incentives inherent in the way

Medicare pays providers. Incentives can take the

form of higher payments for high quality care.

Where quantity is one measure of quality (e.g.,

frequency of visits), then per-unit payment may

provide good incentives. In other cases, workable

measures of quality must be developed so that high

quality can be rewarded (or low quality censured) by

the payment system.

Competition can also be used to ensure quality.

Even when Medicare payments are uniform across

providers, providers in competitive markets may

have to offer services of acceptable quality to attract

Medicare patients and their physicians.

A 1989 study of alternative payment methods for

home health services under Medicare examined

these issues at the theoretical level (381) .6This study

suggested that, while smaller units of payment (e.g.,

per visit) might result in increased utilization, larger

units of payment (e.g., per episode) could result in

reduced quality of services as providers attempted to

cut costs of service (table 7-3) (381). Competitive

bidding models, because they can have considerable

impact on the caseload, market share, and revenues

of both losing and Winning bidders, also present

serious quality and access concerns (381). These

concerns might be exaggerated for a market as new

and diffuse as HDIT. Nonetheless, these findings

suggest that payment methods that create incentives

for providers to cut costs (e.g., per episode, per diem,

monthly rate, competitive bidding) should be balanced by more vigorous quality assurance and

utilization review efforts (381).

When it is too difficult or costly to include

appropriate incentives in the payment system, it may

be necessary to develop a separate quality monitoring and assurance system. Payment can then be

denied when quality measures fall below accepted

standards. (LOW quality of care can result from too

much service as well as too little service. It is

important to ensure that the system does not induce

use of unnecessary care.)

HDIT services, because they can be more narrowly and specifically defined than home health

services in general, may be more conducive to

focused quality assurance measures. These might

include Federal, State, and provider-level quality

assurance initiatives and controls, implemented

through survey and certification of providers, on an

ongoing and systematic basis through providers’

G Impact could not be examined direetly because the intended projeets to demonstrate them were never implemented.
144. Home Drug Infusion Therapy Under Medicare

internal quality assurance programs, and on an

individual case basis (i.e., through preauthorization

and retrospective review by an outside party).

Equity

Inequity among Medicare beneficiaries could

arise if the payment system failed to ensure access to

services in some geographic areas. It could also arise

if patient cost sharing provisions fell disproportionately on one group or another, or if limits on

coverage duration or scope served to deny benefits

to certain groups of patients.

Inequity among providers may result from payment rates that do not account for differences in cost

outside the provider’s control, or from differences in

the way services are reimbursed that may affect

providers differently. For example, a single payment

rate for all HDIT that was based on average costs

over all types of therapy might disadvantage providers who specialize in a particular type of therapy that

is more expensive than average.

Even if payment is equitable across all HDIT.

providers, equity across different settings of care

may be difficult to achieve. There is little a priori

reason to believe that home care is preferable to

outpatient infusion for mobile patients with access to

an outpatient provider, for instance. The method

(and level) of payment chosen for HDIT, however,

could easily cause an inequity between home and

outpatient providers, resulting in possible unintended incentives to use one rather than the other.

Cost Control

Setting Payment Rates:

Marginal Versus Average Costs

Cost control for the Medicare program, beneficiaries, and the health care system overall requires that

payment is not excessive relative to production

costs. Thus, regardless of the payment method

chosen, the payment rate—i.e., the actual amount

paid, regardless of the method in which it is

calculated-is extremely important. From Medicare’s perspective, the best payment rate is the

lowest one that can be obtained without inducing

undesirable changes in provider behavior (e.g.,

refusing to accept Medicare patients). For any

individual provider, the response to a given payment

rate will depend heavily on whether that rate is

above or below the provider’s marginal cost (the

provider’s own production cost of serving one more

patient) and the provider’s average cost of serving

all patients (i.e., total costs divided by total patients

served). 7

For the great majority of providers, setting rates

below marginal costs would probably lead them to

avoid serving Medicare patients (since they would

take a financial loss on every patient). Exceptions

might be publicly subsidized providers (e.g., public

health departments) or providers that could treat the

service as a “loss leader” to induce patients to also

use other, more lucrative services. (Note that any

given payment rate might be below the marginal cost

for most providers but above marginal cost for

others. The latter providers might still be willing to

serve patients.)

If rates were set above marginal cost but below

average cost, most providers would probably continue to serve Medicare beneficiaries. In this case,

even though the rate fails to cover average cost, the

payment received for each Medicare patient covers

the extra cost that the patient generates and makes

some contribution to the provider’s fixed costs.

If payment just covers marginal costs, providers

may be willing to serve Medicare patients if they are

able to charge other payers more than average costs.

Such cost shilling might raise concerns about the

equitable distribution of cost among payers. A very

simple model of home infusion provider behavior

(app. D), however, suggests that rates between

average and marginal cost would result in lower

profits for providers rather than higher rates for other

payers, so cost-shifting and interpayer equity is not

a major issue.

Interprovider equity may be of somewhat more

concern. In some cases, Medicare rates below

average cost might endanger the financial viability

of providers heavily dependent on Medicare patients. So, rates at this level could have an impact on

access to services in some areas and for some types

of providers.

Rates at or above average cost should be

sufficient to induce providers to serve Medicare

beneficiaries where such service can be efficiently

7 Note that neither marginal nor average costs bear any necessary relation to charges. In fac~ in order for a provider to make a profit in the long ~

charges must be higher than average costs. Payments can be less than charges but still higher than average costs.
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare . 145

provided. They could also be viewed as covering

Medicare’s fair share of provider costs. Although

rates above average costs (including a normal profit

or return to invested capital) might be considered

excessive in a world where all providers faced

similar constraints and similar patients, there are

some circumstances in which rates above measured

average cost might be appropriate.

For example, it maybe necessary to pay more than

the average cost of an efficient-size operation to

ensure that services are provided in areas that cannot

support a provider of efficient size. Also, if the

administrative costs of serving Medicare patients are

significantly greater than such costs for other

patients, then it may be desirable or necessary for

Medicare to pay more than the average cost of

serving all the provider’s patients. Third, cost

structures could differ from those postulated in

appendix D. If marginal cost exceeds average cost

(e.g., due to a limited supply of potential staff) and

particularly if there are barriers to entry of new

providers at an efficient size (e.g., startup costs),

then it maybe necessary to pay marginal costs (more

than average cost) to induce supply

minimum of the average cost curve.

Other Cost Containment Mechanisms

Because Medicare pays hospitals

discharge basis, discharging a patient

beyond the

on a perhome early

would result in temporary double-payment for that

patient if the HDIT were covered. One private

insurer with a payment method similar to Medicare’s

authorizes home infusion only for patients whose

posthospital course of therapy is expected to be at

least 7 days (243). This policy reduces the payer’s

short-term costs, but at the expense of also reducing

hospital cost savings that might be reflected in future

lower hospital payment rates.

Reducing hospital payments by some prescribed

amount at the time an HDIT benefit is implemented

would be another way to reduce the program costs of

short-term double-payment. For example, patients

discharged to HDIT could be treated in the same way

as inter-hospital transfers, with the “transferring”

hospital receiving a proportion of the full DRG rate,

based on the number of days the patient was

hospitalized. As yet, however, Medicare has little

solid information on which to base such a policy.

Unknown factors include the extent to which patients could be discharged sooner in the face of an

HDIT benefit; whether the ability to discharge varies

among hospitals; and how hospitals would behave in

the face of such a policy. The concept also violates

one of the basic premises of Medicare’s inpatient

prospective payment system, which is intended to

reward efficiency (and, where appropriate, short

stays) and penalize inefficiency. A demonstration

project could address the former issues, but the latter

ones require a more fundamental policy change.

Administrative Feasibility

Cost and Complexity of Administration

It is not clear whether prospective payment or

retrospective reimbursement methods are generally

most easily administered. It is likely that the many

HDIT providers who have not used Medicare cost

reports (i.e., most providers that are not hospitals or

HHAs) would find prospective rates easier to adopt

than full cost reporting. On the other hand, administering the geographic and annual adjustments to

prospective rates could be difficult and possibly

costly for the Medicare program to do well.

Competitive processes may be the most administratively costly payment methods, because they

require soliciting bids, making awards, and monitoring quality in every market area. Arizona’s competitivebidding-based Medicaid demonstration program, for

example, has administrative costs equal to 12

percent of medical costs, compared with 4 to 7

percent for most other State Medicaid programs

(212). Since the program showed a modest net

savings overall, however, there may well be some

substitution of administrative costs for medical costs

in competitive bidding systems (212).

Government-set prospective rates may require the

greatest difficulty obtaining accurate information to

establish rates. In contrast to cost reimbursement

methods (where the provider’s actual cost is the rate

paid) and competitive payment methods (where the

competitive process effectively generates its own

information through bidding or negotiation), government-set prospective rates require detailed information, of two types. First, the relevant costs used as

the basis for the rates (e.g., average cost) must be

measured or estimated reasonably accurately. Second, legitimate and acceptable variation in costs

must be accounted for. Developing detailed information on variations and methods to account for

differences, if found, could be complex.
146. Home Drug Infusion Therapy Under Medicare

Administrative burdens (e.g., learning Medicare

cost reporting rules) can also affect provider participation. A generous payment rate may overcome

resistance to paperwork burdens, but it may be

preferable and less costly for the program to find

ways to minimize the required provider documentation. Provider complaints about payment systems

often mention payment delays, the need for multiple

types of claims forms and procedures, unanticipated

claim denials, and unreasonably low payment rates.

To the extent that a payment system can limit these

types of problems, provider participation is likely to

be better.

One possible way to reduce administrative burdens for both Medicare and providers, whatever the

payment method chosen, is to consolidate claims

review and payment for HDIT within a few regional

Fls. Precedents for such consolidation exist. TPN

benefits are administered through only two national

FIs. More recently, home health benefit administration has been consolidated among nine regional FIs.

HCFA appears to be satisfied with the benefits of

administrative consistency that have attended consolidation (399).

A final administrative consideration for Medicare

is whether an HDIT benefit should be administered

under Part A or Part B of Medicare. The question is

not trivial, nor the answer obvious, because the

components of HDIT as they are now covered under

Medicare fall in both. DME and associated drug

benefits are usually administered through Part B,

and the Part B carriers currently have the greatest

experience administering a home drug benefit as a

consequence. On the other hand, home health

services are usually administered through Part A

intermediaries. Thus, if one objective is to ensure

coordination of HDIT and other home health benefits, administration through Part A, or through FIs

that administer both Parts A and B, may be

indicated. Conversely, if HDIT patients were excluded from receiving concurrent home health

benefits, it might make more sense to administer an

HDIT benefit through Part B carriers.

Evaluating Payment Alternatives

The possible choices for HDIT payment are many

and could include any of a number of variations on

the payment models described above. This section

assesses basic methods of payment according to the

tradeoffs they entail in the goals of a payment

system.

Retrospective Charge- or Cost-Based

Reimbursement

Cost- or charge-based reimbursement as a method

of payment for HDIT (e.g., as in the existing

Medicare home services model described above)

offers the advantage of promoting provider participation and providing incentives for high quality

care. This method would be easy to implement, since

it fits with existing methods of payment for home

equipment and services. Restricting payment to

cost-based only would be slightly harder to implement, since many HDIT providers do not have

experience with Medicare’s cost reporting system.

The primary disadvantage of cost- and chargebased reimbursement is the lack of incentives for

cost control. Both have inherently inflationary

tendencies, because providers can recoup full costs

(or, for charge-based reimbursement, greater than

full costs) and thus have little reason to seek the best

possible prices from their suppliers. Provider efforts

to constrain their own costs are likely to occur only

if they have a significant fraction of their business

paid on some other basis. Since it appears that many

(if not most) private insurers currently use some

form of charge-based reimbursement for HDIT, this

is not likely to be the case in the immediate future.

Despite its inflationary nature, cost-based reimbursement would not necessarily be more expensive

to the Medicare program than prospective payment

methods. If HDIT is provided with a common

technology in accordance with well-established

professional standards (for frequency of visits,

necessary equipment, credentials of caregivers, criteria for termination of care, etc.) then there maybe

little room for providers to inflate costs or provide

extra services. If home care costs increased only

slowly, and if prospective rates had to be set high

(e.g., to ensure access in all areas, or because the

ratesetting process was ‘captured’ by the industry),

cost-based rates could be lower than prospectively

set rates. Cost-based reimbursement would also

have relatively low startup administrative costs

compared with most other payment methods. Also,

less quality assurance monitoring would be needed

than with other payment methods.
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare ● 147

Competitive Payment Methods

Competitive bidding approaches could be applied

to HDIT. Services are fairly well defined and in

many markets there are sufficient numbers of

potential providers to allow for a truly competitive

process. It would be possible to contract competitively for delivery of HDIT services to Medicare

beneficiaries in individual markets across the counQ .

The principal advantage of competitive approaches

are that market mechanisms are used to set rates. It

would not be necessary to set rates uniformly high to

ensure access in areas with high costs. Through

competition, rates could be established well below

average cost, probably close to marginal cost,

without impairing the access of Medicare beneficiaries to service. Rates could be revised routinely to

reflect changes in cost and technology.

The principal disadvantage of a competitive

payment method is that the costs of administering

such a system could exceed those for a prospective

payment or cost reimbursement system. Although

some competitive systems (e.g., Arizona’s Medicaid

program) have found that savings from low rates

more than balanced the extra administrative costs in

a comprehensive health care plan, Medicare might

be hard-pressed to meet this standard due to the

small market for HDIT. Competition would probably involve multiple bidding processes to cover the

entire country. Also, as this method would give

providers strong incentives to control costs, the same

approaches to quality assurance would be required

that are necessary with prospective government-set

rates. Studies of existing competitive bidding programs have found that excluding quality as a

criterion for award selection and inadequate monitoring of quality have been problems in some of

these programs (380).

To be successful, this payment method requires

that several providers be available in an area to

compete. This may be a problem in sparsely

populated areas with few providers. In addition, if

the initial ‘winners” in a bid gain sufficient market

advantage, the long-term competitiveness of the

market could be endangered. In particular, winner-takeall bidding may promote market concentration and

make future bidding harder to conduct (380). Longterm program costs could rise as a consequence.

Noncompetitive Prospectively Set Rates

Prospective rate setting offers greater direct government control over rates than is possible with cost

reimbursement or competitive methods. This would

promote efficient operations, but it might also lead

to reduced quality of service (e.g., less reliability,

less qualified staff, lower quality supplies, less

internal quality assurance). The extent to which any

cost saving would accrue to Medicare, rather than to

provider profits, would depend on whether future

rates were adjusted downward to reflect the savings.

Inefficient providers and providers with high costs

not fully adjusted for by a geographic wage index

(e.g., those serving high-crime or low-volume areas)

might find it difficult to continue serving Medicare

patients.

As demonstrated by the proposed regulations

pursuant to the MCCA, data limitations may restrict

the exact form of prospective ratesetting that is

immediately possible. In the proposed regulations,

HCFA acknowledged some of the limitations of the

data used to develop the rates and identified areas

where better data may be needed. Data are most

readily available on average costs (in HHAs) and

charges. Little information is available on true

marginal costs, or even average costs of freestanding

HDIT specialty companies. However, estimates of

average variable costs, which were the focus of the

HCFA rates, may closely approximate marginal

Costs.*

Updating Prospective Rates

Adjusting rates for changes over time may be even

more difficult. Changes in the method of delivery in

response to the new financial incentives or technology may make initial rates obsolete rather quickly.

Much of the data used to establish rates comes from

industry surveys. Once it is known that the surveys

are used to set rates, providers may inflate the

reported costs of providing services.

Under the MCCA, HCFA proposed to adjust rates

among geographic areas using a wage index and to

consider annual inflation adjustments. The adequacy

of such a geographic adjustment depends on the

extent to which the wage index reflects true cost

g Wriable costs are those costs that change as output changes. (In the long m most costs are variable, but in the short run variable costs are those

such as supplies, transportation etc. that change as patient caseload increases or decreases.)
148. Home Drug Infusion Therapy Under Medicare

variations among HDIT. Cost of providing HDIT

may vary with local costs of office space, transportation, and liability insurance as well as wages. There

is no good information on the variation of such costs,

so it is not clear whether the geographic wage

adjustments would have been sufficient to ensure

access of Medicare beneficiaries in all areas. If rates

were based on average total costs, they would be at

least as high as marginal cost even in the high-cost

areas. In this case, the adequacy of an adjustment

may be more of an issue of equity among providers

than one of access.

Prospectively set rates are the basis for four very

different models discussed earlier: the all-service

per-month ESRD model, the per-diem MCCA and

private sector models, the per-item private sector

model, and the per-episode models that bundle home

infusion with hospital or home health services.

These models differ in two basic aspects: how they

bundle services across time (e.g., per diem, per

episode of care), and how extensively they bundle

the various components of therapy (e.g., nursing and

pharmacy services, equipment and supplies, drugs

and ancillary services).

Bundling Across Components of Therapy

Bundling services together for payment, as HCFA

proposed to do (under the MCCA) for HDIT nursing

and pharmacy services, supplies, and equipment,

reduces the incentive to provide extra services in the

course of a visit. Bundling services, supplies, and

equipment also encourages use of the most efficient

combination of services. Its drawback is that it could

also lead providers to skimp on provision of services

if competitive forces or quality assurance procedures

are not effective in ensuring provision of needed

service components.

Bundling other components of therapy (e.g.,

drugs, routine laboratory services) into a single

payment rate is also possible, although the Office of

Technology Assessment (OTA) is not aware of any

payers that currently do so for HDIT. The payment

adjustments that might be necessary to accommodate different drug dosages and patient monitoring

needs could be administratively taxing, at least until

payers gain more experience with this therapy.

Alternatively, payments could be made separately

for nursing care, supplies, equipment, pharmacy

services, and all other components of care. As noted

above, however, this is likely to lead providers to

supply as many such services as possible in order to

maximize payments. Providers might also have an

incentive to use expensive equipment, even if it was

of little additional benefit to the patient. Monitoring

the detailed itemization of supplies and equipment to

preclude paying for unnecessary items could be

administratively costly.

If unbundling was coupled with a diffusion of

provider responsibility (from a single agency to

multiple providers), then the quality of patient care

could suffer from lack of coordination. In such

circumstances it might be necessary to add (and pay

for) a case management role to ensure coordination.

An independent case manager could act to prevent

use of unnecessary or unduly expensive services, but

would probably be more costly than if the case

management function was assumed by a provider.

Bundling Across Time

Any prospective payment method that bundles

services across time creates incentives to cut costs

and quality (e.g., by reducing the number of nursing

visits) unless rates are high and there is strong

competition to provide quality services to attract

Medicare patient referrals. Per-diem rates may

include a mild incentive to overuse services toward

the end of therapy, if rates are higher than the daily

costs of serving the patient, though such action

would require the inattention of the patient’s physician. Compared with per-episode rates, per-diem

rates present less risk to the provider-persons with

unusually long episodes of care will produce greater

payments.

Bundling services across time for the purposes of

payment may encounter information problems. In

the hypothetical model described above, for example, in which HDIT would be “bundled” with

hospital care, the lack of information regarding how

to estimate per-DRG costs associated with HDIT

might delay implementation of this method.

Other Issues

Paying for Drug Infusion Therapy

in Skilled Nursing Facilities

For patients who require substantial professional

nursing assistance and who cannot be treated as

outpatients, treatment in SNFs is a potential alternative to hospital inpatient care. Medicare already

covers drug infusion therapy in this setting. Despite
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare ● 149

this apparent coverage, SNF-based infusion therapy

may often be discouraged as unavailable, for four

reasons.

First, most SNFs operate at close to capacity. In

1986, the average occupancy rate for SNFs in the

United States was 92 percent (384). In 11 States, the

average occupancy was over 95 percent (384).

Consequently, admitting a patient to an SNF for

extended drug infusion may often be much more

difficult than prescribing home care for that patient.

Second, Medicare reimbursement for SNFs discourages the provision of most expensive therapies.

Current reimbursement policy is to pay SNFs their

costs, but these payment amounts are subject to a

limit of 112 percent of the median costs for similar

SNFs (74). Thus, any individual SNF is heavily

discouraged from specializing in drug infusion

therapy, which increases both supply and nursing

costs.

Parenteral nutrition products provided to SNF

patients are an exception to this reimbursement rule.

When these products are provided by an outside

supplier, who bills Medicare directly, their costs are

not borne by the SNF. SNFs who likewise succeed

in billing some drug infusion costs separately under

Part B may be able to mitigate some of the

disincentives for providing this therapy under Part A

SNF payment.

Third, most SNFs do not have staff qualified to

administer infusion therapy, and if most of a SNF’s

patients require less medically intensive care it has

little incentive to recruit (and pay for) such personnel. Staffing issues may be a greater barrier than

reimbursement to providing infusion therapy in

many SNFs (133).

And fourth, Medicare coverage rules encourage

SNF residents who develop a need for drug infusion

to be rehospitalized for the therapy. By doing so, the

beneficiary can often become re-eligible for Medicare’s limited SNF benefits (133).

If Medicare covers HDIT, it may also wish to

provide more balanced incentives to provide the

therapy in SNFs for patients whose need levels make

them expensive to Medicare to treat at home. Drug

infusion therapy could, like parenteral nutrition, be

recognized as a separate component and either billed

directly by the provider or treated as a SNF

“pass-through,” not subject to the limits. Alternatively, SNFs could be reimbursed in a manner that

was more directly related to the level of care

provided. SNF reimbursement systems that link

payment to patient resource needs are currently

under development (300).

Higher extended-care payments for patients on

drug infusion therapy would also benefit rural

hospitals who must discharge such patients to swing

beds for lack of other nonhospital providers (see ch.

6). Swing-bed care is reimbursed by Medicare at the

average rate that Medicaid pays for SNF-level care

in the different States (298). Swing-bed units might

need higher payments to accommodate the higher

service levels presumably needed to administer drug

infusion therapy safely.

Physician Compensation and Ownership

HDIT requires substantial physician involvement.

Physicians must assess the patient’s medical condition, order the appropriate therapy, monitor the

patient’s ongoing health status at home, manage

complications or changes in prescription needs,

document all medical management, and respond to

any emergencies. Furthermore, greater physician

involvement and cooperation with other HDIT

professionals probably leads to higher quality care

(see ch. 5).

Except for reimbursement related to predischarge

hospital visits and office visits during the course of

therapy, however, physicians generally receive no

compensation for performing these activities. The

lack of direct payment for services that take place

over the telephone or require substantial paperwork

is a disincentive for some physicians to refer patients

to home care generally (6,203). This may be one

cause of the finding that, although the role of home

health services has increased, physicians’ involvement in home health care has decreased (12). The

problem is exacerbated in the case of HDIT by the

extensive and ongoing need for medical advice and

decisionmaking during therapy.

At present, one way for physicians to receive

greater financial rewards for the patients they refer

to HDIT is by receiving some form of compensation

from the home providers themselves. Compensation

may take any of a number of forms. For example,

according to some individuals interviewed by OTA

staff, a physician may receive a “consulting fee”

from the home provider, with the amount of the fee
150. Home Drug Infusion Therapy Under Medicare

linked to the number of patients referred by the

physician.9 Alternatively, the physician may actually share ownership of the home provider itself,

thus receiving a share of the profits of that provider,

which result in part from the number of patients

referred.

Physician ownership of health facilities is a

common phenomenon. Over 8 percent of physicians

who are members of the American Medical Association (AMA) report ownership interest in at least one

health facility, and 6 percent refer patients to that

facility (66). A study by the Office of Inspector

General (OIG) found that 15 percent of physicians

who bill Medicare have some kind of financial

arrangement with a health care entity to which those

physicians refer patients (383). Physician ownership

is similarly common in the home infusion industry.

For example, T2, a home drug infusion company

based in Georgia, is owned primarily by physicians

who own stock in the company. As of 1990, the

company owned 42 centers and managed another51

centers (222). Furthermore, the independently owned

centers managed by the company are themselves

owned by physicians.

Financial inducements are not the only mechanisms by which providers may stimulate referrals.

Hospitals, for instance, may offer physicians gratuities such as free office space in exchange for the

relocation of the physician’s practice to that hospital

(383). The OIG study found that 8 percent of

physicians billing Medicare receive nonfinancial

compensation in exchange for patient referrals, such

as office space rental agreements, employee arrangements, and management service contracts (383).

Inducements can be negative as well as positive.

Hospitals that own HHAs, for example, may pressure physicians with hospital admitting privileges to

refer their patients to the hospital’s agency rather

than to alternative sources of care.

Any business arrangement by which the physician

receives financial compensation for the patients he

or she refers to another provider raises both ethical

and legal issues. Opponents to such arrangements

have argued that they involve an inherent and

unnecessary conflict between the physician’s responsibility for the patient’s well-being and his or

her interest in financial reward (279,280). The

conflicts of interest may be especially strong if the

physician’s financial interest in the referral is not

disclosed to the patient (279,280).

There is some evidence that physician ownership

of health facilities is related to higher use of those

facilities’ services. Government studies of diagnostic imaging centers and clinical laboratories owned

by referring physicians have reported that these

facilities performed more tests, and the referring

physicians ordered more tests, than comparable

physicians and independently owned facilities (356,

383). A study of primary care physicians who owned

their own radiology equipment likewise found that

patients were at least four times as likely to have

diagnostic imaging done if the patient’s prescribing

physician was self-referring, and charges for these

procedures were often relatively high as well (157).

A recent study of physician-owned facilities in

Florida found that results varied somewhat depending on the type of facility (321). This study found the

most problems with clinical laboratories, diagnostic

imaging centers, and physical therapy/rehabilitation

centers. Physician-owned facilities in these categories had clearly increased costs, charges, and/or

utilization, or were associated with greater access or

quality problems, compared with comparable facilities. The report was not able to draw clear conclusions regarding problems with the other four types of

facilities studied (ambulatory surgical centers, DME

suppliers, HHAs, and radiation therapy centers).

HDIT providers were not specifically examined in

thiS study.

There is little consensus among physician associations regarding the acceptability of different ownership and other financial arrangements. The AMA,

for example, holds that physician ownership of

health facilities is both ethical and acceptable (13).

The American College of Surgeons and the American College of Radiology takes the position that

self-referrals are potentially unethical and generally

not in the best interest of the patients (9). The

strongest position on physician ownership has been

taken by the Committee on Implications of ForProfit Enterprise in Health Care (drawn from the

councils of the National Academy of Sciences, the

National Academy of Engineering, and the Institute

of Medicine), which regarded it as unethical and

g Such armngements are not limited to home infusion therapy; for example, hospitals suffering great f~cial losses have offered physicians

compensation disguised as “consulting fees” in order to reeruit staff physicirms (383).
Chapter 7—Paying for Home Drug Infusion Therapy Under Medicare . 151

unacceptable for physicians to have ownership

interests in health care facilities to which they make

referrals or to receive payments for making referrals

(137). The committee recommended the use of

physician compensation systems that break the link

between the decisions physicians make in treating

their patients and the rate of return they earn on

investments in their medical practice.

In some circumstances, compensation for referrals is illegal. The Medicare and Medicaid Antikickback regulations prohibit offering, soliciting, paying, or receiving any remuneration, whether director

indirect, for:

● referring an individual to a provider for the

receipt of an item or service that is covered by

Medicare or Medicaid; or

. purchasing, leasing, or ordering any item or

service that is covered by Medicare or Medicaid.

Under the antikickback law, it is not only unethical but illegal for physicians to refer Medicare or

Medicaid patients to a health care facility in

exchange for remuneration. This provision has been

upheld stringently by the courts. In a 1989 appeals

court decision, the court found that the antikickback

statute is violated unless payments are ‘‘wholly and

not incidently attributable to the delivery of goods

and services. ” (U.S. v. Kats [871 F.2d 105, 9th Cir.

1989]).

In contrast, it is not illegal under present statutes10

for physicians to invest in most kinds of health care

centers and refer their patients to those centers.

Certain types of facilities have been singled out,

however. The Omnibus Budget Reconciliation Act

of 1989 (public Law 101-239) prohibits physicians

who own or invest in clinical laboratories from

referring Medicare patients to these facilities for

laboratory testing. 11 The repealed MCCA would

have prohibited payment for HDIT services provided by a company in which the physician ordering

the services had a financial interest. (This prohibition was repealed along with the act.)

Despite its potential for abuse, physician ownership of health facilities may sometimes be not only

acceptable but desirable. In some places, for example, a physician-owned health care unit maybe the

only such unit available; prohibiting payment for

these services could be a barrier to basic access of

health care.

Although ownership of HDIT providers was the

focus of concern under the MCCA, drug infusion

therapy services provided through a physician’s own

office may be at least as widespread a phenomenon.

Banning this practice is tantamount to banning the

dispensing of drugs in a physician’s office and

affects not only the physician’s freedom to invest at

will but his or her freedom to enter into certain kinds

of personal practice. Ownership in both HDIT

companies and office-based provision of HDIT raise

similar concerns regarding referrals. Office-based

infusion therapy raises a broad range of other issues

as well, however, and policymakers may wish to

distinguish between the two.

1° 42 U.S.C. 1395nn(b)

11 ~~mvision took effect on JZUI~ 1* 1992.
APPENDlXES
Appendix A

METHOD OF THE STUDY

History of the Project

The origins of this study lie in the passage of the

Medicare Catastrophic Coverage Act of 1988 and its

subsequent repeal in 1989. As part of a broad coverage

expansion that would have extended Medicare coverage

to outpatient prescription drugs, that act would have

resulted in greater coverage of outpatient immunosuppressive drugs (now limited to coverage for only 1 year),

and it would have established a home intravenous drug

therapy benefit. With the repeal of that act, these two more

specific coverage expansions once again became issues

before Congress.

In April of 1990, the Senate Committee on Finance

asked the Office of Technology Assessment (OTA) to

revisit these two topics and the relevant coverage and

payment issues they involve. The proposed assessment

was approved by OTA's congressional Technology

Assessment Board in June 1990 and begun the following

month. The assessment was conducted in two parts

leading to two separate reports, one on immunosuppressive drugs and one on home intravenous drugs and other

drugs infused at home.

Conduct of the Home Drug Infusion Therapy

(HDIT) Study

During the fall of 1990 and the frost 6 months of 1991,

OTA staff reviewed the literature on HDIT and interviewed experts in home care, medicine, intravenous

nursing, clinical pharmacy, and infusion equipment

manufacturing. Project staff also met several times with

individuals at the Health Care Financing Administration

to learn from their experience with HDIT coverage after

the Medicare Catastrophic Coverage Act, and with

several private insurance company representatives regarding the experiences of private payers with HDIT.

In the course of the interviews and literature review, it

became clear that objective and detailed information on

many aspects of HDIT was incomplete or lacking entirely.

To gain a more comprehensive understanding of the

therapy and the industry that provides it, OTA made a

number of site visits to providers. The organizations

visited included a spectrum of hospital-, pharmacy-, home

health agency-, and specialty-company-basecl HDIT programs. A list of these organizations appears at the end of

this appendix. In addition, staff met with provider

representatives at OTA and held extensive telephone

interviews. OTA staff also met with individuals from

organizations that include HDIT providers among their

members.

OTA also requested detailed data on such aspects as

provider structure and summary patient information from

the providers contacted. Few providers were able to

supply these data, lending insights into the information

difficulties a Medicare policy might face.

Most major OTA studies have a panel of outside

experts chosen to advise OTA staff on the study and

ensure that all significant points of view are represented.

This study was originally intended to be performed in

coordination with an ongoing study of drug research and

development, with the same advisory panel. It transpired,

however, that the two studies had little directly in

common, and the advisory panel for the earlier study

proved inappropriate for the existing study. Because of

the short timeframe anticipated for this study, it also

proved infeasible to appoint a separate advisory panel at

the point for the current study.

To ensure that sufficient expert advise was obtained

and that all viewpoints were represented, OTA staff took

great care to involve a variety of outside persons in the

review of the draft material. A preliminary draft was sent

to nearly 100 experts in the field, including HDIT

providers, manufacturers, health professional and patient

organizations, health care payers, researchers, and others

with interest and knowledge in the area of HDIT for their

review and comment. Fifteen representatives of the major

organizations concerned with HDIT met at OTA for a

public discussion of the draft on September 10, 1991 (see

p. v of this report). The final draft, incorporating revisions

based on reviewers’ comments and discussion at the

public meeting, was transmitted to the Technology

Assessment Board in October 1991.

Contractors providing material to OTA for this study

were:

Julia T. Ostrowsky, Chicago, IL, survey of Medicare

Part B carriers regarding coverage of and payment for

drugs used in infusion pumps under the durable medical

equipment (DME) benefit, conducted February 1991.

Thomas W. Grannemann, Lexington, MA, “Incentives

and Behavioral Responses to Alternative Payment Methods for Home Intravenous and Immunosuppressive Drug

Therapies Under the Medicare Program,” prepared under

contract to the Office of Technology Assessment, February 1991.

-155-
156. Home Drug Infusion Therapy Under Medicare

OTA Site Visits to HDIT Providers

Anne Arundel General Hospital Outpatient IV Therapy

Services Program

Annapolis, MD

November 1990

Caremark

Columbia, MD

August 21, 1990

Handmaker Home Health Services, Inc.

Tucson, AZ

May 2, 1991

Infusion Care

Columbia, MD

August 2,1990

Jefferson County Department of Health

Birmingham, AL

November 1, 1990

HMSS, Inc..

Phoenix, AZ

May 3, 1991

New England Critical Care

Columbia, MD

August 21, 1990

Jefferson (Hospital) Home Infusion Service

Philadelphia, PA

September 20, 1990

University Medical Center Home Health Services, Inc.

Tucson, AZ

May 2, 1991

Vital Care, Inc.

Livingston, AL

November 2, 1990

Visiting Nurses Association of Washington

Washington, DC

February 4, 1991

Provider Visits to OTA

ABEL Health Management Services, Inc.

November 9, 1990

Arlington Cancer Center

April 25, 1991

Kimberly Quality Care

January 23, 1991
Appendix B

ACKNOWLEDGMENTS

This report was greatly aided by the assistance of many individuals who provided OTA staff with information and

advice over the course of the study. OTA extends particular thanks to those persons who participated in the workshop

discussion of the draft report (see inside front cover) and to the following individuals. (These individuals do not

necessarily either agree or disagree with the findings and conclusions of this report. OTA assumes full responsibility for

the report and the accuracy of its contents.)

Ed Abel

ABEL Health Management Services, Inc.

Great Neck, NY

Carol Anderson

American Association of Blood Banks

Arlington, VA

Tess Angeles

Perivascular Nurse Consultants

Rockledge, PA

Teri Bair

Johnson & Gibbs

Dallas, TX

Joseph Baker

CHAMPUS

Aurora, CO

Paul Barber

American Association of Blood Banks

Arlington, VA

Ira Bates

National Hospice Organization

Alexandria, VA

Katherine Bennett

Advanced Metabolic Systems, Inc.

Washington, DC

Dale Benzine

T

2 Medical, Inc.

Alpharetta, GA

Douglas Berchard

University of Tennessee

Chattanooga, TN

Beverly Black

American Society of Hospital Pharmacists

Bethesda, MD

Flora Blackledge

Jefferson County Department of Health

Birmingham, AL

Donald Blair

State University of New York

Syracuse, NY

Marvin Blitz

Empire Blue Cross Blue Shield

New York, NY

Lori Bodenheimer

National Capitol Area Blue Cross and Blue Shield

Washington, DC

Patricia Booth

Chevy Chase, MD

Diane Boyer

VNA of Washington

Washington, DC

Lisanne Bradley

Health Care Financing Administration

Rockville, MD

Anne Burden

VNA of Washington

Washington, DC

Bart Clark

National Association of Boards of Pharmacy

Park Ridge, IL

Brian Crawford

Vital Care, Inc.

Livingston, AL

Sam Dellavecchia

Health Care Financing Administration

Baltimore, MD

Joanna Dixon

National League for Nursing

New York, NY

Bill Dombi

National Association of Home Care

Washington, DC

Burton Dunlop

Project HOPE

Chevy Chase, MD

Robert Ernst

Home Infusion Services

Pittsburgh, PA

-157 -
158. Home Drug Infusion Therapy Under Medicare

Chuck Faxon

Sun Belt Pharmacare

San Antonio, Tx

Lorraine Ferry

Universal Management Systems, Inc.

Newton Square, PA

Ruth Galten

National Association for Home Care

Washington, DC

John Gans

American Pharmaceutical Association

Washington, DC

Irene Gibson

Health Care Financing Administration

Baltimore, MD

Jade Gong

American Health Care Association

Washington, DC

Sarah Gregg

Baxter Healthcare Corp.

Washington, DC

Stuart Guterman

Prospective Payment Assessment Commission

Washington, DC

Lynn Hadaway

Menlo Care, Inc.

Menlo Park, CA

Susanne Harding

Infections Limited, P.S.

Tacoma, WA

David Higbee

Health Care Financing Administration

Baltimore, MD

Jimmy Hindman

Vital Care

Livingston, AL

Tom Hoyer

Health Care Financing Administration

Baltimore, MD

Charlotte Hughes

Olsten Health Care

Tampa, FL

Brian Hyps

American Pharmaceutical Association

Washington, DC

Sam Jamopolis

Arlington Cancer Center

Arlington, TX

Craig Jeffries

Health Industry Distributors Association

Alexandria, VA

Christian Khung

Blue Cross Blue Shield of Massachusetts

North Quincy, MA

Chris Kozma

University of South Carolina

Columbia, SC

Milt Lehman

Parenteral Alimentation Providers Association, Inc.

Larkspur, CA

Keith Lind

National Alliance for Infusion Therapy

Washington, DC

Sue Masoorli

Perivascular Nurse Consultants

Gaithersburg, MD

Mary Monk

University of Mississippi

University, MS

W. Steven Murray

Healthcare Solutions, Inc.

Torrance, CA

Donna Nemer

Arizona Blue Cross and Blue Shield

Phoenix, AZ

Marsha Nusgart

Health Industry Manufacturers Association

Washington, DC

Helayne O’Keiff

Barnes Home Health Agency

St. Louis, MO

Karen Pace

National Association for Home Care

Washington, DC

Alan Parver

National Alliance for Infusion Therapy

Washington, DC

Jere Paulmeno

IVION Corp.

Denver, CO

Daniel Paxton

Cystic Fibrosis Foundation

Bethesda, MD

Raymond Pontzer

Home Infusion Services

Pittsburgh, PA
Appendix B-Acknowledgments . 159

Lt. Col. Maureen Potter John Swenson

CHAMPUS Valley Medical Center

Aurora, CO Renton, WA

Michael Prime Brian Swift

O.P.T.I.O.N. Care, Inc. Jefferson Home Infusion Service

Chico, CA Philadelphia, PA

Timothy Redmon Keven Thompson

National Association of Retail Druggist National Capitol Area Blue Cross and Blue Shield Alexandria, VA Washington, DC

Steve Richards

Minnesota Blue Shield

St. Paul, MN

Sharon Riser

Perivascular Nurse Consultants

Gaithersburg, MD

Karen Snow Rizzo

UMC Home Health Services, Inc.

Tucson, Arizona

Anne Rooney

Joint Commission on Accreditation of Healthcare

Organizations

Oakbrook Terrace, IL

James Todd

American Medical Association

Chicago, IL

Tim Vanderveen

San Diego, CA

Jolee Verbeke

Pharmacia Deltec, Inc.

St. Paul, MN

Paul Vitale

Anne Arundel Medical Center

Annapolis, MD

William Saunders Mary Weick

Health Care Financing Administration Food and Drug Administration

Baltimore, MD Rockville, MD

Jane Sisk

Dobbs Ferry, NY

Stan Wyremski

ABEL Health Management Services, Inc.

William Slattery Great Neck, NY

ABEL Health Management Services, Inc.

New York, NY Robert Zone

Equicor

Susan Slaughter Nashville, TN

San Diego, CA

OTA also acknowledges the assistance of individuals from the following organizations, without whom the survey

of carrier policy would not have been possible:

Aetna-Arizona and Nevada Arkansas Blue Cross and Blue Shield

Phoenix, AZ Little Rock, AR

Aetna Georgia Indiana Blue Shield

Downer’s Grove, IL Indianapolis, IN

Aetna—Hawaii Blue Cross and Blue Shield of Arkansas-Louisiana

Honolulu, HI Baton Rouge, LA

Aetna-New Mexico/Oklahoma Blue Cross and Blue Shield of Colorado

Albuquerque, NM Denver, CO

Aetna-Oregon and Alaska Blue Cross and Blue Shield of Illinois

Portland, OR Chicago, IL

Alabama Blue Shield Blue Cross and Blue Shield of Kansas City

Birmin gham, AL Kansas City, MO
160. Home Drug Infusion Therapy Under Medicare

Blue Cross and Blue Shield of Michigan

Detroit, MI

Blue Cross and Blue Shield of Montana

Helena, MT

Blue Cross and Blue Shield of North Dakota/Wyoming

Fargo, ND

Blue Shield of Rhode Island

Providence, RI

Blue Shield of Western New York

Binghamton, NY

California Blue Shield

San Francisco, CA

Empire Blue Shield

New York, NY

Equicor-Maho

Boise, ID

Equicor North Carolina

Greensboro, NC

Equicor Tennessee

Nashville, TN

Florida Blue Shield

Jacksonville, FL

General American Life Insurance Co.

St. Louis, MO

Group Health Incorporated

New York, NY

Iowa Blue Shield

Des Moines, IA

Kansas/Nebraska Blue Shield

Topeka, KS

Kentucky Blue Shield

Lexington, KY

King County Medical Blue Shield

Seattle, WA

Maryland Blue Cross and Blue Shield

Timonium, MD

Massachusetts Blue Cross and Blue Shield

Boston, MA

Minnesota Blue Shield

St. Paul, MN

Nationwide Insurance Co.

Columbus, OH

Pennsylvania Blue Shield—New Jersey

Lawrenceville, NJ

South Carolina Blue Shield

Columbia, SC

Texas Blue Shield

Dallas, TX

Transamerica Occidental Life Insurance Co.

Los Angeles, CA

Travelers of Connecticut

Hartford, CT

Travelers of Minnesota

Bloomington, MN

Travelers of Mississippi

Jackson, MS

Travelers of Virginia

Richmond, VA

Utah Blue Shield

Salt Lake City, UT

Wisconsin Physicians’ Service

Madison, WI
Appendix C

HOME INTRAVENOUS DRUG THERAPY: PROPOSED REGULATIONS

UNDER THE MEDICARE CATASTROPHIC COVERAGE ACT

The Medicare Catastrophic Coverage Act of 1988

(Public Law 100-360) included a new Medicare benefit

that would have covered home intravenous drug therapy.

The act, and the benefit, were repealed the following year.

Shortly before the repeal, however, the Health Care

Financing Administration (HCFA) had published proposed regulations to implement this new benefit. Although the proposed rules were never made final, they

generated considerable comment from the industry, and

they represent a potential baseline against which any

future related policies can be compared.

The remainder of this appendix presents exerpts from

the Federal Register that relate to coverage and payment

for home intravenous drug therapy. Exerpts are ordered as

follows:

●

●

●

●

●

list of covered home intravenous drugs (54 F.R.

37239, Sept. 7, 1989);

payment for covered outpatient drugs (54 F.R.

37208, Sept. 7, 1989);

coverage of home intravenous drug therapy services

(54 F.R. 37422, Sept. 8, 1989);

payment for home intravenous drug therapy services

(54 F.R. 46938, NOV. 8, 1989); and

conditions of participation for home intravenous

drug therapy providers (54 F.R. 37220, Sept. 7,

1989).

Specific relevant sections and paragraphs are exerpted

verbatim (including abbreviations), but sections omitted

are not explicitly indicated. Headings and some sections

have been reformatted for publication purposes in this

report.

List of Covered Home IV Drugs (54 F.R. 37239)

This notice sets forth a list of intravenous drugs that we

[HCFA] propose to cover on the basis that they can be

safely and effectively administered in the home. The

notice would implement section 1861(t)(4) of the Social

Security Act as added by section 202(a) of the Medicare

Catastrophic Coverage act of 1988.

Home IV Coverage

Section 202(a) of Pub. L. [Public Law] 100-360

amended sections 1861(s)(2)(J) and (t) of the Act to

provide general coverage for outpatient prescription

drugs under Part B and to authorize Part B coverage of

home IV drugs. In addition, section 203 of Pub. L.

100-360 added sections 1861(jj), 1834(d) and 1835(a)(2)(G)

to the Act and amended other related sections to authorize

coverage of home IV therapy services. For purposes of

this new home IV benefit, under new section 1861(t)(4)(B)

of the Act, we are required to publish, by January 1, 1990

and periodically thereafter, a list of covered home IV

drugs, and their indications, that can be safely and

effectively administered in the home.

It is this list of drugs that we are addressing in this

proposed notice. Proposed rules setting forth regulations

to implement the various other provisions of Pub. L.

100-360 dealing with the outpatient prescription and

home IV drug benefits will be published in separate

documents as follows:

●

●

●

Overall coverage of outpatient prescription drugs

(including drugs used in immunusuppressive therapy and home IV drugs).

Payment methodology for covered outpatient prescription drugs (which will apply also to covered

home IV drugs).

Coverage of home IV drug therapy services.

Conditions of participation for home TV drug therapy

providers.

Fee schedule for home IV drug therapy services.

Deductible and coinsurance amounts and the Part B

cap on out-of-pocket expenses.

Participating pharmacies.

Drug bill processors.

Coverage of catastrophic Part B expenses, outpatient

drug expenses, and respite care benefits for beneficiaries enrolled in pre-pay health plans, such as health

maintenance organizations.

The statute provides specific definitions of “covered

outpatient prescription drugs” and of what constitutes

‘‘covered home IV drugs. In order to be a covered home

IV drug, the drug must first qualify as a covered outpatient

prescription drug as described below.

Section 202(a) of Pub. L. 100-360 amended sections

1861(s)(2)(J) and (t) of the Act by establishing the

following definition of a “covered outpatient drug,”

which includes drugs, biological products, and insulin.

Drugs-A drug that may be dispensed only upon

prescription and that meets one of the following requirements:

The drug is approved for safety and effectiveness as

a prescription drug under sections 505 or 507 of the

FFDCA [Federal Food, Drug, and Cosmetic Act], or

approved under section 505(j) of the FFDCA.

-161-
162. Home Drug Infusion Therapy Under Medicare

. The drug was commercially used or sold in the

United States before the date of enactment of the

Drug Amendments of 1%2 (October 10, 1%2) or it

is identical, similar or related to such a drug, as

defined by 21 CFR 310.6(b)(l). Nevertheless, such

a drug will not be covered if the Secretary has made

a final determination that it is a “new drug’ and has

not been approved under sections 505 or 507 of the

FFDCA, or if it is subject to certain actions brought

by the Secretary to enforce provisions of sections

502(f), or 505(a) of the FFDCA (21 U.S.C. 352(f), or

355(a)).

. The drug is described in section 107(c)(3) of the

Drug Amendments of 1962 and is one for which the

Secretary has determined there is compelling justification for its medical need, or it is identical, similar,

or related to such a drug. Also, the drug must be one

for which the Secretary has not issued a notice to

withdraw approval for marketing, because the Secretary has determined that the drug is less than

effective for all conditions of use represented,

recommended, or suggested on its labeling. These

are the ‘‘DESI’ [Drug Efficacy Study Implementation] drugs.

Biological products—A biological product is considered a “covered outpatient drug” if it is one that may be

dispensed only upon prescription, is licensed under

section 351 of the PHS [Public Health Service] Act (42

U.S.C. 262), and is produced at an establishment licensed

under that Act to produce that product.

Insulin—Insulin is covered if it is certified under

section 506 of the FFDCA (21 U.S.C. 356) for the

strength, quality, and purity necessary to ensure adequate

safety and efficacy of use. In accordance with section

1861(t)(2)(C) of the Act, as amended by Pub. L. 100-360,

insulin would be considered a “covered outpatient drug”

whether or not it is dispensed under a prescription.

In addition, section 202(a)(2)(C) of Pub. L. 100-360

added sections 1861(t)(4)(A) and (B) to the Act to define

“covered home IV drugs” as covered outpatient drugs

that are intravenously administered to individuals in

places of residence that are used as the individuals’

homes. The definition includes:

Antibiotic drugs unless the Secretary has determined, for a specific drug or for the indication for

which it is applied, that the drug cannot generally be

administered safely and effectively in a home

setting; and

Drugs that are not antibiotics, but only if the

Secretary has determined that for a specific drug and

the indications for which the drug is being applied

that it can generally be administered safely and

effectively in a home setting.

Process Followed in Compiling the Drug List

Description of the Process-As noted above, section

202(a)(2)(C) of Pub.L. 100-360 added section 1861(t)(4)(B)

to the Act to require us to develop a list of covered home

IV drugs by January 1, 1990. These drugs must meet

definitions of a “covered outpatient drug” set forth in

new sections 18 61(t)(2) and (2) or the Act and of a

“covered home IV drug” set forth in new section

1861(t)(4)(A) of the Act.

Our task with respect to putting together a proposed list

of covered home IV drugs has been twofold. First, we had

to compile a list of IV drugs (both antibiotics and

non-antibiotics) and their indications. Second, in accordance with section 1861(t)(4) of the Act, we had to

identify from that list those IV drugs that are safe and

effective for use in the home. In accordance with section

1861(t)(4)(A)(ii) of the Act, our rules for including

antibiotics and non-antibiotics differed. We obtained

information about IV drugs based on the following

categories:

. Antibiotic IV drugs, and indications for which each

drug is applied, that can generally be safely and

effectively administered in the home.

. Non-antibiotic IV drugs, and indications for which

each drug is applied, that can generally be safely and

effectively administered in the home. We separated

this category into the following groups:

—Anti-infectives (other than antibiotics);

—Hydration therapy;

—Pain management drugs;

—Antineoplastic drugs; and

-Other drugs.

In determining which drugs may be administered

intravenously, we obtained the following lists from the

FDA:

●

●

●

All IV drugs that are currently approved by the FDA

for marketing,

DESI drugs, [and]

“Compliance Report for DESI-2,” also referred to

as the “B List” of unapproved drugs that are

currently marketed.

The drugs that we considered for our proposed list had

to meet the statutory definition of “covered outpatient

drug” and can be found on one of these FDA generated

lists. Before we reviewed a specific drug for possible

inclusion as a “covered home IV drug,” the drug had to

meet this initial requirement, as set forth in section

1861(t) of the Act.

In listing the drugs, we decided to place together in one

list all those drugs, both antibiotics and non-antibiotics,

that we initially propose as being covered. We believe

setting forth a comprehensive list of covered drugs for
Appendix C-Home lntravenous Drug Therapy:Proposed Regulations Under the Medicare Catastrophic CoverageAct ● 163

purposes of rulemaking will make it easier for the public

to direct their comments appropriately to a specifically

named drug or indication, as opposed to our soliciting

comments on those antibiotics and their indications that

we propose not to cover. As discussed below, we

encountered special problems with unlabeled indications

for antibiotics in this regard. Therefore, [Table C-1] to this

notice contains a list of drugs and indications that we

propose to cover. [Table C-2] contains a list of antibiotics

and indications that we propose not to cover.

We want to emphasize that we do not have the

discretion under the home IV drug benefit to pay for a

drug or an indication that is not on the final list. Section

1861(t)(4)(A) of the Act, as added be section 202(a) of

Pub. L. 100-360, limits coverage of home IV drugs to

those drugs that the Secretary has determined are safe and

effective for use in the home. Any drug or indication not

addressed on the final list to be published after we

consider and evaluate public comments on the attached

proposed list, or any drug or indication not included in a

subsequent update, would not meet this requirement and

payment would not be made for that drug or indication.

To obtain advice in determining whether an IV drug

should be included in our proposed list of IV drugs as

being safe and effective for use in the home, we contacted

the following organizations:

. The U.S. Pharmacopoeia (UPS).

. The American Society of Hospital Pharmacists

(ASHP).

. The American Medical Association (AMA).

● Various home IV providers (recognized in he field of

home IV therapy).

● The pharmaceutical Manufacturers Association.

● Various drug manufacturers.

We requested that these sources submit a list of IV

drugs that, in their opinion, could generally be safely and

effectively administered in the home, and, in addition, any

other information they thought pertinent. Although all of

the organizations we contacted did not respond with

recommendations about drugs suitable for home use, we

did receive specific recommendations based on reviews

by advisory panels, medical and clinical evidence to

support inclusion of certain drugs, lists of IV drugs that

are currently being administered in the home setting, and

recommendations for exclusions.

In addition, we contacted the publishers of the following compendia:

United States Pharmacopoeia Dispensing Information, Volume 1 (Drug Information for the Health

Care Professional)(USP DI);

American Medical Association’s Drug Evaluations

(AMADE): and

. American Hospital Formulary Service Drug Information (AHFS DI).

Based on the information we received from all of these

sources, we constructed an initial list of IV drugs that we

considered for inclusion on the proposed list as being safe

and effective for home use. (At this point, the list included

certain antineoplastic drugs but did not include 12 of the

antibiotic drugs that were included on the master list of IV

drugs submitted to us by the FDA. For reasons discussed

below, neither of these groups of drugs is included in

[table C-l].) We then obtained form the FDA the labeled

indications for these drugs.

For the purpose of determining unlabeled uses of

approved drugs, we relied on the information provided by

the three compendia and the suggestions of the various

home IV providers.

Having put together the list of IV drugs and indications,

we then submitted it to health care professionals recommended to us by the Intravenous Nurses Society and the

AMA [American Medical Association]. We requested

that these individuals examine the list from a clinical

perspective and we received several clinical recommendations.

As noted earlier, our rules for including antibiotic and

non-antibiotic drugs on the proposed list have differed.

The law requires the Secretary to coverall antibiotic drugs

unless the Secretary makes the determination that a

specific antibiotic cannot generally be administered

safely and effectively in the home. The list of IV drugs we

initially obtained from the FDA included identification of

all IV antibiotic drugs that are currently available on the

market. Of those antibiotic drugs, there were 12 antibiotics that we are proposing as not generally being safe and

effective for use in the home.

It is our understanding that the following factors may

prevent these 12 drugs that we propose for exclusion from

being safe or effective when administered in the home

setting:

. Potential serious or life-threatening side effects;

● Stringent monitoring requirements that could not

effectively be performed in the home setting; and

. Stability limitations.

We list these 12 antibiotics below and specifically

solicit comments and information about these drugs and

their indications that might be relevant to a final

determination about their suitability for use in the home.

The drugs are:

1. Chloramphenicol sodium succinate

2. Colistimethate sodium

3. Doxycycline hyclate

4. Erythromycin gluceptate

5. Ervthromvcin lactobionate
164. Home Drug Infusion Therapy Under Medicare

Table C-l—Proposed List of Covered Home IV Drugs and Indications

Approved drug/Approved conditions

Antibiotics

Amdinocillin

Urinary tract infections,

bacterial

Amikacin sulfate

Bone and joint infections

Endocarditis, bacteria

Genitourinary tract infections

Skin and soft-tissue infection

Urinary tract infections, bacterial

Ampicillin sodium

Arthritis, gonococcal

Bone and joint infections

Endocarditis, bacterial

Entercolitis, “Shigella”

Genitourinary tract infections

Gonorrhea

“Hemophilus” infections

Listeriosis

Paratyphoid fever

Skin and soft-tissue infections

Urethritis, gonococcal

Ampicillin sodium and sulbactam sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract injections

Skin and skin structure infections

Azlocillin sodium

Bone and joint infections

Endocarditis, bacterial

Skin and skin structure infections

Urinary tract infections, bacterial

Aztreonam

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Carbenicillin Disodium

Genitourinary tract infections

Skin and soft-tissue infections

Urinary tract infections, bacterial

Cafamandole nafate

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Cefonicid sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Cefoperazone sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Ceforanide

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Approved drug/Approved conditions

Skin and skin structure infections

Urinary tract infections, bacterial

Cefotaxime sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Cefotetan disodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Cefoxitin sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Ceftazidime

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Ceftizoxime sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Ceftriaxone sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Lyme Disease, joint and Central Nervous System (CNS)

Cefuroxime sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Gonorrhea

Cephalothin sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and soft tissue infections

Urinary tract infections, bacterial

Cephapirin sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Cephradine

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial
Appendix C-Home lntravenous DrugTherapy: Proposed Regulations Under the Medicare Catastrophic Coverage Act . 165

Table C-l—Proposed List of Covered Home IV Drugs and Indications-Continued

Approved drug/Approved renditions Approved drug/Approved conditions

Clindarnycin phosphate

Bone and joint infections

Genitourinary tract infections

Skin and soft tissue infections

Gentamicin sulfate

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Listeriosis

Imipenem and Cilastatin Sodium

Bone and joint infections

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Methicilin sodium

Endocarditis, bacterial

Skin and soft tissue infections

Mezlocillin sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Miconazole

Candidiasis, disseminated

Candidiasis, mucocutaneous, chronic

Petriellidiosis

Urinary bladder infections, fungal

Nafcillin sodium

Endocarditis, bacterial

Skin and soft tissue infections

Netilmicin Sulfate

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Oxacillin sodium

Endocarditis, bacterial

Skin and soft tissue infections

Penicillin G Potassium

Arthritis, gonococcal

Diphtheria, prophylaxis

Endocarditis, bacterial

Genitourinary tract infections

Gingivostornatitis, necrotizing

ulcerative

Listeriosis

Lyme disease, joint and CNS

Syphilis

Penicillin G sodium

Arthritis, gonococcal

Diphtheria prophylaxis

Endocarditis, bacterial

Genitourinary tract infections

Gingivostomatitis, necrotizing ulcerative

Listenosis

Lyme disease, joint and CNS

Syphilis

Piperacillin sodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Urethritis, gonococcal

Ticarcillin disodium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and soft tissue infections

Urinary tract infections, bacterial

Ticarcillin disodium and

clavulanate potassium

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Tobramycin sulfate

Bone and joint infections

Endocarditis, bacterial

Genitourinary tract infections

Skin and skin structure infections

Urinary tract infections, bacterial

Listenosis

Vancomycin hydrochloride

Bone and joint infections

Endocarditis, bacterial

Non-antibiotic drugs

Anti-in fectives (other than antibiotics)

Acyclovir sodium

Herpes zoster

Herpes simplex

Pentamidine isethionate

Pneumonia, “Pneumocystis carinii”

Leishmaniasis, visceral

Tryponosomiasis, African

Sulfamethoxazole and trimethoprim

Bone and joint infections

Chancroid

Chlamydial infections

Enterocolitis “Shigella”

Genitourinary tract infections

Gonorrhea

“Hemophils” infections

Lymphogranuloma venereum

Paratyphoid fever

Pneumonia, “Pneumocystis carinii”

Rheumatic fever

Urinary tract infections, bacterial

Hydration Therapy

Intravenous solutions

1. Dextrose in water solutions

2. Sodium chloride solutions

3. Dextrose/sodium chloride solutions

4. Premixed potassium chloride solutions up to concentrations of

40 mEq/Lip

The following limitations apply for all of the above solutions:

a concentration of dextrose in any solution is not to exceed

10%.

b. concentration of sodium chioride in any solution is not to

exceed 0.9°/0.

(continued on next page)
166. Home Drug Infusion Therapy Under Medicare

Table C-l—Proposed List of Covered Home IV Drugs and Indications-Continued

Approved drug/Approved conditions Approved drug/Approved conditions

5. premixed electrolyte solutions, containing any combination of

the following electrolytes in their various salt forms, which are

not intended for parenteral nutrition:

Sodium

Potassium

Calcium

Magnesium

Chloride

Phosphate

The caloric content of these solutions is limited to 340 calories.

Electrolytes

1. Calcium chloride

2. Calcium glumnate

3. Calcium glucepate

4. Magnesium chloride

5. Magnesium sulfate

6. Potassium acetate

7. Potassium chloride

8. Potassium phosphate

9. Sodium acetate

10. Sodium bicarbonate

11. Sodium chloride

12. Sodium phosphate

The indications for drugs in this category are less specific than

for other drugs. After referring to various clinical tests, we have

determined that water depletion, and combined water and

electrolyte depletion, can be the result of many disease and

non-disease states, including but not limited to the following:

Extrarenal losses

1. Gastrointestinal (vomiting, diarrhea, ostomy drainage)

2. Skin losses (sweating, burns)

3. Lung losses (bronchorrhea)

Renal losses

1. Renal disease (chronic renal failure, diuretic phase of acute

renal failure)

2. Diuretic excess

3. Osmotic diuresis (diabetic glycosuria)

4. Mineralcorticoid deficiency (Addison’ s disease, hypoaldosteronism)

There may be other instances when a patient needs hydration

therapy. Patients taking antineoplastic drugs must often be

hydrated to increase urine output to insure the timely excretion of

the drug because of its toxic side effects.

Pain Management Drugs

Indication: for treatment of chronic intractable pain.

Butorphanol tartrate

Hydromorphone hydrochloride

Meperidine hydrochloride

Morphine sulfate

Other

Aminophylline

Asthma, bronchila

Bumetanide

Edema

Cimetidine hydrochloride

Adenoma, multiple endocrine

Bleeding, upper gastrointestinal

Hypersecretory conditions, gastric

Mastocytosis, systeic

Pancreatic insufficiency

Reflux, gastroesophagel

Stress-related mucosal damage

Ulcer, duodenal

Ulcer, gastric

Zollinger-Ellison syndrome

Deferoxamine mesylate

Toxicity, iron chronic

Toxicity, aluminum

Dexamethasone sodium phosphate

Adrenocortical insufficiency, chronic primary (Addison’s)

Adrenomrtical insufficiency, secondary

Adronogenital syndrome (adrenal hyperplasia, congenital)

Anemia, hemolytic, acquired (autoimmune)

Anemia, hypoplastic, congenital (erythroid)

Anemia, red blood cell (erythroblastopenia)

Arthritis, psoriatic

Arthritis, rheumatoid

Bowel disease, inflammatory, including colitis, ulcerative

Bronchitis, asthmatic, acute or chronic

Calcium pyrophosphate deposition disease, acute (pseudogout,

chondrocalcinosis articularis, synovitis, crystal-induced)

Carcinoma, breast

Carcinoma, prostatic

Connective tissue disease, mixed

Dermatitis, exfoliative

Dermitis herpetiformis bullous

Dermatitis, seborrheic, severe

Dermatomyositis, systemic

Dermatoses, inflammatory, severe (Stevens-Johnson

syndrome)

Fever, due to malignancy

Gouty arthritis, acute

Hemolysis

Hypercalcemia associated with neoplasms (or sarcoidosis)

Increased cranial pressure due to malignancy

Leukemia acute or chronic

Lupus erythematosus, systemic

Lymphomas, Hodgkins, or non-Hodgkins

Multiple myelome

Mycosis fungoides

Nausea and vomiting, cancer-chemotherapy induced

Penphigoid

Pemphigus

Polychondritis, relapsing

Polymyalgia, rheumatic

Polyps, nasal

Pulmonary disease, chronic obstructive (not controlled with

theophylline and beta-adrenergic agonists)

Reiter’s disease

Rheumatic fever

Rhinitis, allergic, perennial, or seasonal, severe

Thrombocytopenia secondary in adults

Thrombocytopenia purpura, idiopathic, in adults

Trichinosis

Diphenhydramine hydrochloride

Nausea and vomiting

Famoticine

Adenoma, multiple endocrine

Bleeding, upper gastrointestinal

Hypersecretory conditions, gastric

Mastocytosis, systemic

Pancreatic insufficiency

Reflux, gastroesophageal

Stress-related mucosal damage

Ulcer, duodenal

Ulcer, gastric

Zollinger-Ellison syndrome
Appendix C—Home Intravenous Drug Therapy: Proposed Regulations Under the Medicare Catastrophic Coverage Act . 167

Table C-l—Proposed List of Covered Home IV Drugs and indications-Continued

Approved drug/Approved conditions Approved drug/Approved conditions

Furosemide

Edema

Heparin Calcium

Heparin sodium

Thromboembolism

Hydrocortisone sodium phosphate

Hydrocortisone sodium succinate

Adrenocortical insufficiency, chronic primary (Addison’s)

Adrenocortical insufficiency, secondary

Adrenogenital syndrome (adrenal hyperplasia congenital)

Anemia, hemolytic, acquired (autoimmune)

Anemia, hypoplastic, congenital (erythroid)

Anemia, red blood cell (erythroblastopenia)

Arthritis, psoriatic

Arthritis, rhematoid

Bowel disease, inflammatory, including colitis, ulcerative

Bronchitis, asthmatic, acute or chronic

Calcium pyrophosphate deposition disease, acute (pseudogout,

chondrocalcinosis articularis, synovitis, crystal-induced)

Carcinoma, breast

Carcinoma, prostatic

Connective tissue disease, mixed

Dermatitis, exfoliative

Dermatitis, herpetiformus, bullouss

Dermatitis, seborrheic, severe

Dermatomyositis, systemic

Dermatoses, inflammatory, severe

Enteritis, regional (Crohn’s disease)

Erythema multiform, severe

Fever, due to malignancy

Gouty arthritis, acute

Hemolysis

Hypercalcemia associated with neoplasms (or sarcoidosis)

Increased cranial pressure, due to malignancy

Leukemia, acute or chronic

Lupus erythematosus, systemic

Lymphomas, Hodgkin’s or non-Hodgkin’s

Multiple myeloma

Mycosis fungoides

Nausea and vomiting, cancer chemotherapy induced

Pemphigoid

Penphigus

Polychondritis, relapsing

Polymyalgia, rheumatic

Polyps, nasal

Pulmonary disease, chronic obstructive

Reiter’s disease

Rheumatic fever

Rhinitis, allergic, perennial or seasonal, severe

Thrombocytopena, secondary, in adults

Thrombocytopenia purpura, idiopathic, in adults

Trichinosis

Iron dextran

Iron deficiency anemia

Leucovorin calcium

Methotresate toxicity (antidote to folic acid antagonist)

Mannitol

Premeditation, cancer chemotherapy

Methylprednisolone sodium succinate

Adrenocortical insufficiency, chronic primary (Addison’s)

Adrenocortical insufficiency, secondary

Adrenogenital syndrome (adrenal hyperplasia, congenital)

Anemia, hemolytic, acquired (autoimmune)

Anemia, hypoplastic, congenital (erythroid)

Anemia, red blood cell (erythroblastopenia)

Arthritis, psoriatic

Arthritis, rhematoid

Bowel disease, inflammatory, including colitis, ulcerative

Bronchitis, asthmatic, acute or chronic

Calcium pyrophosphate deposition disease, acute (pseudogout,

chondrocalcinosis articularis, synovitis, crystal-induced)

Carcinoma, breast

Carcinoma, prostatic

Connective tissue disease, mixed

Dermatitis, exfoliative

Dermatitis, herpetiformus, bullouss

Dermatitis, seborrheic, severe

Dermatomyositis, systemic

Dermatoses, inflammatory, severe

Enteritis, regional (Crohn’s disease)

Erythema multiform, severe

Fever, due to malignancy

Gouty arthritis, acute

Hemolysis

Hepatitis, chronic active

Hepatitis, nonalcoholic, in women

Hypercalcemia associated with neoplasms (or sarcoidosis)

Increased cranial pressure, due to malignancy

Leukemia, acute or chronic

Lupus erythematosus, systemic

Lymphomas, Hodgkin’s or non-Hodgkin’s

Multiple myeloma

Mycosis fungoides

Necrosis, hepatic, subacute

Pemphigoid

Penphigus

Polychondritis, relapsing

Polymyalgia, rheumatic

Polyps, nasal

Pulmonary disease, chronic obstructive

Reiter’s disease

Rheumatic fever

Rhinitis, allergic, perennial or seasonal, severe

Thrombocytopenia secondary, in adults

Thrombocytopenia purpura, idiopathic, in adults

Trichinosis

Metoclopramide

Gastroparesis

Nausea and vomiting, cancer chemotherapy induced

Phenytoin Sodium

Epilepsy

Prochlorperazine Edisylate

Nausea and vomiting

Ranitidine hydrochloride

Adenoma, multiple endocrine

Bleeding, upper gastrointestinal

Hypersecretory conditions, gastric

Mastocytosis, systemic

Pancreatic insufficiency

Reflux, gastroesophageal

Stress-related mucosal damage

Ulcer, duodenal

Ulcer, gastric

Zollinger-Ellison syndrome

Biologlcals and Indications

Immune globulin

Immunodeficiency syndrome

Thrombocytopenic purpur~ idiopathic

Alpha-proteinase inhibitor, human

Emphysema panacinar, due to alpha-antitrypsin deficiency
168. Home Drug Infusion Therapy Under Medicare

Table C-2—Proposed List of Non-Covered Home IV

Antibiotic Drugs and Indications

Antibiotic Drugs Not

Proposed for Coverage Conditions

Chloramphenicol sodium Biliary tract infections

succinate Central nervous system

Colistimethate sodium infections

Doxycycline hyclate Intra-abdominal infections

Erythromycin glucepate Respiratory tract infections

Erythromycin Iactobionate Septicemia

Kanamycin sulfate

Lincomycin hydrochloride

Minocycline hydrochloride

Moxalactum disodium

Oxytetracycline hydrochloride

Polymyxin B sulfate

Tetracycline hydrochloride

6. Kanamycin sulfate

7. Lincomycin hydrochloride

8. Minocycline hydrochloride

9. Moxalactum disodium

10. Oxytetracycline hydrochloride

11. Polymyxin B sulfate

12. Tetracycline hydrochloride.

In addition, we want to note that, in our administrative

process of assembling the list of antibiotic drugs (covered

and noncovered), we believe that we have addressed all

antibiotic drugs currently on the market. However, the

introduction of new drugs into the marketplace is an

ongoing occurrence. In addition, it is not inconceivable

that in our process, we may have inadvertently missed an

antibiotic drug. Therefore, we also invite public comment

concerning antibiotics that do not appear in either

appendix.

For non-antibiotic drugs, the Secretary has to make a

determination that a drug can generally be safely and

effectively administered in the home. Therefore, before

and IV drug could be placed on Appendix I, we had to

develop evidence from which that determination could be

made. We derived this list based on consultations with the

USP DI and the AHFS DI, providers of home IV therapy,

and a review of available medical and scientific information.

With respect to the antineoplastic drug subcategory, we

initially considered the following drugs for inclusion on

the list:

1.

2.

3.

4.

5.

6.

7.

8.

Bleomycin sulfate

Cyclophosphamide

Cytarabine

Daunorubicin hydrochloride

Diethylstilbestrol diphosphate

Doxorubicin hydrochloride

Etoposide

Fluorouracil

9. Methotrexate sodium

10. Mitomycin

11. Mitoxantrone hydrochloride

12. Streptozocin

13. Vinblastine sulfate

14. Vincristine sulfate.

Concerns were raised throughout the process of developing and clearing the list about the general safety of this

group of drugs when administered intravenously in the

home setting. A review of the drug labels revealed that of

the 14 drugs in this category, 12 of them had warnings that

specified that the drug should be administered by or under

the supervision of a qualified physician who is experienced in cancer therapy. In addition, several drugs had

additional warnings that patients should have access to or

be treated in a facility with laboratory and supportive

resources sufficient to monitor drug tolerance. We also

reviewed the National Institutes of Health (NH) recommended guidelines for the ‘‘Handling of Parenteral

Antineoplastic Drugs” prepared in collaboration with

oncologists, the clinical center pharmacy (within NIH),

oncology nurses, and National Cancer Institute staff. With

these factors to consider, and mindful also of the extensive

safety requirements these factors could necessitate in the

conditions of participation for home IV drug providers,

we concluded that we are not able to propose, at this time,

that these drugs could be safely and effectively administered intravenously in the home. In order to be consistent

with the approved FDA labeling, we made the decision to

remove these drugs from [table C-l]. Because of the

concern about whether antineoplastics are safe for use in

the home, we have decided to seek further advice form the

Public Health Service on this matter. Coverage of

antineoplastic drugs under the home IV therapy benefit

will accordingly be deferred pending receipt of such

advice.

Use of Compendia—We selected the three compendia

listed above as reliable sources for some of the advice and

information we needed based on the recommendations

contained in the Conference Report accompanying Pub.

L. 100-360 (H.R. Report No. 661, 100th Congress, 2d

Session 192 (1988)). In the report, the three compendia

are suggested for consideration as references for a related

purpose under the new drug benefit, that is, for purposes

of the establishment of standards for covered outpatient

prescription drugs, as required under the new section

1834(c)(5)(B) of the Act (as added by section 202(b)(4)

of Pub. L. 100-360). Since Congress recognized these

compendia as authoritative for one purpose under the new

drug benefit, we believe it is appropriate to rely on them

for a related similar purpose under that benefit.

In addition, the USP DI is sponsored by the USP, and

organization that includes members of schools of medicine and pharmacy, State medical and pharmacy associations, national medicine and pharmacy associations. Its
Appendix C—Home Intravenous Drug Therapy: Proposed Regulations Under the Medicare Catastrophic Coverage Act . 169

listing of drugs includes virtually all drugs approved in

the United States. The USP DI staff prepare monographs

after a literature search and review of FDA approved

labeling. (A monograph is an essay or treatise on the

available data for a specified drug.) These monographs

are reviewed by over 300 additional experts, plus many

schools, associations, pharmaceutical companies, and

government agencies. They are again reviewed by advisory panels until a consensus is developed. Proposed

monographs are then published in the USP DI Review for

general public comment before being published in the

USP DI. The USP DI is republished annually with six

supplements per year and contains individual monographs, most information from the FDA-approved label,

and unlabeled uses of approved drugs.

The AHFS DI is sponsored by the American Society of

Hospital Pharmacists, which represents 22,000 pharmacists. AHFS DI staff prepare monographs after a literature

search and review of FDA labeling. These monographs

are reviewed by over 300 specialists at the doctoral level,

including physicians, pharmacologists, and biochemists

selected form among experts in drug therapy. This review

process continues until a consensus is developed. The

AHFS DI includes individual drug monographs with

some general category statements, full FDA label disclosure, and unlabeled uses of approved drugs. The AHFS DI

is republished annually with three to four supplements per

year.

The ANA DE is sponsored by the AMA, which

represents over 293,000 physicians. The listed drugs

include all drugs approved by the FDA for use in the

United States. AMA staff prepare monographs after a

literature search and review of FDA approved labeling.

These monographs are reviewed by about 400 consultants

followed by approximately 100 designees or members of

the American Society for Clinical Pharmacology and

Therapeutics. The review process continues until a

consensus is developed. The AMA DE includes mostly

general statements with truncated drug monographs

including unlabeled uses of approved drugs. The AMA

DE has been published every 3 years with updates.

However, beginning in late 1989, the AMA plans to

publish this copendium annually with quarterly updates.

Description of the List

[Table C-1] consists of IV drugs and their indications

divided into three main categories. The categories are:

biological, antibiotics and non antibiotics (which is

further broken down as indicated above into the four

subcategories of drugs, excluding for reasons discussed

above antineoplastic drugs). The list is based on our

analysis and evaluation of the recommendations and

information received from the various professional organizations that we contacted. [Table C-2 contains a list] of

the antibiotic drugs and indications not proposed for

coverage.

We recognize that there is wide variation in both the

type of drugs included in [table C-1] as well as the

indications for these drugs. This is due in part to the fact

that the concept of home IV therapy has evolved to treat

diverse types of patients:

Patients who began a course of IV therapy in the

hospital that has not been completed, but who are

stable enough to no longer require hospitalization.

Patients who are terminally ill and require IV

therapy, but whose condition does not warrant

hospitalization.

Other types of patients who require IV therapy but do

not require hospitalization.

We are proposing that all candidates for home IV

therapy meet specific selection criteria as outlined in the

regulations referred to earlier that deal with coverage of

home IV drug therapy services and conditions of participation for home IV drug therapy providers.

While many of the drugs on the proposed list can be

safely and effectively administered in the home setting

and would be covered, such medications are sometimes

taken orally. Payment may be denied if a more appropriate

route of administration is available. When deciding that

the route of administration is appropriate, the Peer Review

Organization (PRO) will carefully review to determine if

another route of administration would be effective (for

example, oral, subcutaneous, etc.). If the PRO makes a

determination that another route would be effective, the

PRO would deny payment. (An example might be: a

physician seeking prior approval for the administration of

intravenous Aminophylline.) Payment is made for home

IV therapy only when it is reasonable and necessary and

there is medical justification for its use.

The proposed list includes some very toxic drugs while

other less toxic drugs are excluded. We note, however,

that in urging us to include virtually all IV drugs on the

list, some organizations we contacted took the position

that “a drug is a drug, and a cell is a cell.” These

organizations believe a drug that can be administered in

a hospital setting can also be administered in the home

setting. We take a different view. There are a variety of

factors that we have considered that play a role in the

determination of whether a drug is safe and effective for

use in the home. These factors include, in addition to the

obvious factor of potential serious or life-threatening side

effects, drug product stability and compatibility characteristics, and the need for close patient monitoring.

The variation of indications for each specific drug is a

reflection of the varying degrees and stages of illnesses

that will be treated in the home setting. We believe that we

must allow flexibility to enable the physician to develop

297-913 0 - 92 - 12
170. Home Drug Infusion Therapy Under Medicare

a plan of treatment appropriate for the specific medical

condition of the patient. Nevertheless, we wish to make

clear that the appearance of an indication for a covered

drug on the listing is not intended to imply that the

indication is approved under the provisions of the

FFDCA.

With respect to the specific working of the indications,

because there are different phrases to describe the same

disease states and conditions, there may appear to be

inconsistencies in our use of medical terminology when

listing indications. According to medical professionals

and medical texts, the following terms are examples of

terms that may be used interchangeably:

. Genitourinary infections with gynecological infections; and

. Skin and soft-tissue infections with skin and skin

structure infections.

Also, there may be times when a specific indication

could be considered as a subset of a larger classification.

Examples of these would include:

● Cystitis as part of urinary tract infections; and

. Gonorrhea as part of genitourinary infections.

Such indications may have been listed separately in

Appendix I because that is the way they appeared in the

recommendations that we received. In addition, because

the practice of medicine is dynamic, it would not be

feasible to list all indications, either labeled or unlabeled,

that are not suitable for treatment in the home. For this

reason, we have listed the indications for each drug that

can generally be treated safely and effectively in the

home. The following indications are proposed for exclusion for all intravenous antibiotics because it is our

understanding that the seriousness of the condition

requires hospitalization.

1.

2.

3.

4.

5.

Biliary tract infections.

Central nervous system infections.

Intra-abdominal infections.

Respiratory tract infections.

Septicemia.

Furthermore, specific labeled indications for certain

drugs have been excluded because it is our understanding

that they could not be safely and effectively treated

intravenously in the home.

One of our proposed subcategories is “hydration

therapy.’ For our purposes and purposes of home IV

therapy, the term is defined as the replacement of fluids

or electrolytes, or both, in the human body when the

physiologic and homeostatic mechanisms, which normally preserve their balance, fail as a result of illness or

disease.

Most of the drugs that appear on the proposed list have

specific dosages or dose ranges and are given at specific

time intervals. For example, Cimetidine, used for hypersecretory conditions has a recommended dosing schedule of 300 mg administered intravenously every 6-8

hours. In comparison, for hydration therapy purposes, a

physician can prescribe any of numerous available

solutions used for this purpose, with the addition of one

or more of the listed electrolytes, in a dose he or she has

determined to be appropriate (for example, dextrose 5

percent in sodium chloride 0.45 percent, 1000 ml with 7

mEq of calcium as the chloride, gluconate or glucepate

salt).

The magnitude of different combinations of ingredients

in this subcategory requires our format for listing drugs in

hydration therapy to differ from the other categories. This

means that the options available to a physician prescribing

a course of hydration therapy for a Medicare beneficiary

would not be limited. The only restrictions on amounts of

ingredients are those placed on solutions. These limitations have been determined to be the upper limits of

commercially available products that would normally be

used for hydration therapy (versus parenteral nutrition).

We are aware that our list will need periodic revision

as new drugs are approved by FDA for entry in the

marketplace. The FDA has informed us that 10-20 new IV

drugs are approved over the course of each year that we

would have to consider for entry on the list. In addition,

if a drug already on the list is removed from the market or

if a drug is no longer considered to be appropriate for

home use, we would delete the drug from the list. We will

update the list at least annually through a notice in the

Federal Register. Updates may occur more frequently,

possible as often as semi-annually.

Regulatory Impact Statement

Executive Order 12291 (E.O. 12291) requires us to

prepare and publish a regulatory impact analysis for any

proposed notice that meets one of the E.O. criteria for a

“major rule”; that is, that would be likely to result in:

●

●

●

An annual effect on the economy of $100 million or

more;

A major increase in costs or prices for consumers,

individual industries, Federal, State, or local government agencies, or geographic regions; or

Significant adverse effects on competition, employment, investment, productivity, innovation, or on the

ability of United States-based enterprises to compete

with foreign-based enterprises in domestic or export

markets.

Also, we generally prepare a regulatory flexibility

analysis that is consistent with the Regulatory Flexibility

Act (REA) (5U.S.C. 601 through 612) unless the Secretary certifies that a proposed notice would not have a
Appendix C-Home lntmvenous Drug Therapy:Proposed Regulations Under the Medicare Catastrophic Coverage Act ● 171

significant economic impact on a substantial number of

small entities. For purposes of the RFA, pharmaceutical

manufacturers and physicians are considered small entities.

As noted earlier in this preamble, this notice addresses

the issues of:

1.

2.

Identifying IV drugs (both antibiotics and nonantibiotics) and their indications that are approved

for marketing by FDA; and

Identifying those IV drugs that are safe and effective

for use in the home. There maybe some economic

or other effects of the proposed list of drugs that may

touch upon other proposed rules implementing

other home IV provisions of the catastrophic

legislation, and some of these effects are addressed

here as well as in the other rules. The purpose of this

duplication is to ensure that the reader may determine the effects of each document without referring

to the other proposed documents.

In addressing the first issue discussed above, all of the

IV drugs listed in this notice may be covered under

Medicare as covered outpatient drugs because they meet

the criteria defined in section 1861(t)(2) of the Act. Thus,

HCFA has exercised no administrative discretion in this

area.

Administrative discretion, however, was required to

identify those IV drugs that are safe and effective for use

in the home. As discussed earlier in this preamble, we

contacted the USP, ASHP, AMA, various home IV

providers, the Pharmaceutical Manufacturers Association, various drug manufacturers and the Intravenous

Nurses Society in making our initial determination as to

whether a certain IV drug could be proposed as safe and

effective for use in the home. We believe that the

information solicited from the compendia along with the

advice of the other organizations constitutes a valid basis

on which to conclude with reasonable assurance that a

particular drug can generally be administered safely and

effectively in a home setting. Furthermore, we believe that

the identification of IV drugs that are safe and effective for

use in the home would not result in any significant effects

on the economy or on small businesses. Our reasons

follow:

Effects on Drug Manufacturers-Drug manufacturers producing IV drugs that are included in this proposed

list would be advantaged in competing for the Medicare

market because their drugs would be covered under

Medicare as home IV drugs. We recognize that manufacturers producing IV drugs that are not included in our

proposed list would be adversely affected in competing

for the Medicare share of the IV drug market. Although

we do not have data available that allow us to determine

the degree to which drug manufacturers would be

affected, we do not believe that will be significantly

affected. This is because IV drugs (except antineoplastics)

currently being prescribed for home use would likely be

included on the proposed list based on the methodology

used in developing this list.

Effects on Beneficiaries-Medicare beneficiaries who

are prescribed an IV drug for home use that is on the

proposed list would benefit by being eligible for Medicare

coverage of that drug. Conversely, beneficiaries for whom

a drug has been prescribed that is not covered by Medicare

for home IV use may have to remain in the hospital to

receive covered IV therapy or may have to incur expenses

for home IV therapy themselves. Since we believe that

most drugs currently prescribed for home IV use are

included on the list, we do not believe beneficiaries would

be significantly affected adversely.

Effects on Physician-If drugs commonly prescribed

by a physician for use in the home are not on the list, the

physician could be influenced to change his or her

prescribing patterns for Medicare patients to ensure that

the patient is prescribed a Medicare covered home IV

drug. However, given that we have consulted with various

professional organizations and compendia in developing

this list, we believe that the list, with the exception of

antineoplastices, contains the most frequently prescribed

home IV therapy drugs. Thus, we believe it unlikely that

physicians’ prescribing patterns would change significantly as a result of this list.

For the reasons discussed above, we believe that this

notice would not meet the $100 million criterion nor do

we believe that it meets the other E.O. 12291 criteria.

Therefore, we have determined that this notice is not a

major rulemaking document under E.O. 12291, and a

regulatory impact analysis is not required. Also, for the

reasons discussed, we have determined, and the Secretary

certifies, that this notice would not have a significant

economic impact on a substantial number of small

entities. Therefore, a regulatory flexibility analysis would

not be required under RFA.

Payment for Covered Outpatient Drugs

(54 F.R. 37208)

This proposed rule sets forth the methodology for

determin ing payment for covered outpatient drugs under

the new catastrophic drug benefit. This proposal would

implement sections 1834 (c)(2), (3), and (4) of the Social

Security Act as added by section 202(b) of the Medicare

Catastrophic Coverage Act of 1988. Coverage of and

payment for these covered outpatient drugs under Part B

of Medicare would be implemented on January 1, 1990

for drugs used in immunosuppressive therapy and covered home intravenous (IV) drugs and on January 1, 1991

for all other drugs.
172. Home Drug Infusion Therapy Under Medicare

Purpose

This subpart implements section 1834(c) of the Act in

part by specifying how payments are made for covered

outpatient drugs under the catastrophic drug benefit.

Definitions

For purposes of this subpart, the following definitions

apply: Average price means the price that is determined

through the use of either published or survey data

concerning amounts pharmacies pay for drug products.

Multiple source drug means a covered outpatient drug for

which there are two or more drug products that meet all

of the following conditions during payment calculation

period:

(a) Therapeutically equivalent. The drug products

are rated as therapeutically equivalent by the Food

and Drug Administration (FDA) in its most recent

publication of “Approved Drug Products with

Therapeutic Equivalence Evaluations. ”

(b) Pharmaceutically equivalent and bioequivalent

(1) Except as provided in paragraph (b)(2) of this

section, the drug products have been determined by FDA to be pharmaceutically equivalent and bioequivalent.

(2) The drug products are not required to meet the

condition concerning pharmaceutically equivalency and bioequivalency as set forth in

paragraph (b)(l) of this section if FDA changes

by regulation (after an opportunity for public

comment of 90 days) the requirement that, for

Purposes of the Approved Drug Products

with Therapeutic Equivalence Evaluations,”

in order for drug products to be rated as

therapeutically equivalent, they must be pharmaceutically equivalent and bioequivalent.

(c) Available for sale or marketing. The drug

products are considered to be available for sale or

marketing. Drug products meet this condition if

they are listed by FDA in its most recent publication of ‘Approved Drug Products with Therapeutic Equivalence Evaluations” (other than in the

Discontinued Drug Product List in the publication)

unless HCFA determines that sale or marketing is

not actually occurring.

Nonmultiple-source drug means a covered outpatient

drug that does not meet the definition of a “multiplesource drug.” Payment calculation period means the

6-month period beginning January 1st of each year or the

6-month period beginning July 1st of each year.

Determination of Amount Payable

(a) General. The amount payable for a covered

outpatient drug under the catastrophic drug benefit

(b)

as described in 410.29 of this chapter is the

applicable payment percent for the drug as determined under 414.514 multiplied by the lesser of:

(1) The actual charge; or

(2) The payment limit determined under 414.506.

Effective date. Payment is determined under the

criteria described in paragraph (a) of this section

for:

(1)

(2)

Drugs dispensed for immunosuppressive therapy after a transplant or covered home IV

drugs on or after January 1, 1990; and

All other covered outpatient drugs dispensed

on or after January 1, 1991.

Determination of the Payment Limit

(a)

(b)

General. To determine the payment limit for a

drug, HCFA uses the procedures set forth in

paragraph (b) or (c) or this section.

Nonmultiple-source drug and multiple-source

drug with a restrictive prescription. For a

nonmultiple-source drug and multiple-source drug

with a restrictive prescription as described in

414.508, the payment limit is determined as

follows:

(1) For drugs dispensed on or after January 1,

1990 and before January 1, 1992, the payment

limit is equal to the sum of:

(i) The amount of the administrative allowance as set forth in 414.512; and

(ii) The product of the number of tablets or

other dosage units dispensed and the

dosage unit average price as determined in

414.510 for the payment calculation period in which the drug is dispensed.

(2) For drugs dispensed on or after January 1,

1992, the payment limit is equal to the lesser

of:

(i)

(ii)

(c) Multiple-source drug without a restrictive preThe amount of the administrative allowance plus the product of number of tablets

or other dosage units dispensed and the

average price per dosage unit determined

under 414.510 for the payment calculation period in which the drug is dispensed;

or

The 90th percentile of actual charges for

a drug for the second previous payment

calculation period or other dosage units

dispensed.

scription. For a multiple-source drug without a

restrictive prescription, the payment limit is equal

to the sum of:
Appendix C—Home Intravenous Drug Therapy:Proposed Regu/ations Under t he Mediicare Catastrophic Coverage Act . 173

(1) The administrative allowance; and

(2) The product of the number of tablets or other

dosage units dispensed and the dosage unit

average price based on the unweighed median

determined under 414.510 for the payment

calculation period in which the drug is dispensed.

Determining Whether a Prescription Is Restrictive:

(a)

(b)

(c)

General. A drug has a restrictive prescription if it

meets the conditions set forth in either paragraph

(b) or paragraph (c)of this section.

Handwritten prescription. In the case of a

written prescription for a drug, only if the prescribing physician (or other person prescribing the

drug) includes in his or her handwriting the phrase

“brand medically necessary.’

Telephoned prescription. In the case of a prescription for a drug that is telephoned to-the

pharmacy, the prescribing physician (or other

legally authorized person who is prescribing the

drug) indicates that the particular drug must be

dispensed by stating the phrase “brand medically

necessary” both:

(1) During the telephone call; and

(2) Within 30 days after the telephone call, in a

written and signed confirmation, in his or her

handwriting to the pharmacy.

Determination of Dosage Unit Average Price

(a)

(b)

(c)

General. HCFA determines the average price on

a per dosage unit basis for purchases in reasonable

quantities, as appropriate, based on prices in effect

on the first day of the previous payment calculation

period. The average price is based on dosage form

and strength for each drug product.

Sources for dosage unit average price. HCFA

obtains the information described in paragraph (a)

of this section from the lower of:

(1) When available, a biannual survey of a

representative sample of direct sellers, wholesalers, or pharmacies as appropriate; or

(2) Prices published in commonly recognized,

comprehensive listings of drug prices.

Performance of surveys.

(1) Nonmultiple-source drugs.

(i) HCFA performs the biannual survey described in paragraph (b)(1) of this section

for those nonmultiple-source drugs that

are commonly prescribed to Medicare

beneficiaries except that this survey does

not have to be performed in:

(A) Any year in which HCFA determines

that a survey is not appropriate for a

(d)

(e)

(f)

specific covered outpatient drug; or

(B) In years subsequent to 1990, any year

in which HCFA determines that there

is a low volume of sales for a drug.

(ii) The dosage unit average price is based on

the median of the surveyed prices.

(2) Multiple-source drugs. HCFA performs the

biannual survey described in paragraph (b)(1)

of this section for multiple-source drugs, but

only if HCFA determines a survey to be

appropriate. The dosage unit average price is

based on the unweighed median of the

surveyed prices.

Use of published prices.

(1)

(2)

Nonmultiple-source drugs and multiplesource drugs with restrictive prescriptions.

The dosage unit average price for nonmultiplesource drugs and multiple-source drugs with

restrictive prescriptions is based on the lowest

published price.

Multiple-source drugs without restrictive prescriptions. The dosage unit average price for

multiple-source drugs without restrictive prescriptions is based on the unweighed median

of published prices.

National determination. The determination of

the dosage unit average price is made on a national

basis unless HCFA makes the determination on a

regional basis to take into account limitations on

the availability of drugs and variations on the

prices among different areas.

Discounts. In determiningg the dosage unit average

price, HCFA does not consider discounts.

Administrative Allowance

(a) For 1990 and 1991. For a drug dispensed on or

after January 1, 1990 and before January 1, 1992,

the administrative allowance for dispensing the

drug is:

(1) $4.50 per prescription for a pharmacy that

meets the requirements under subpart B of part

490 of this chapter for a participating pharmacy; or

(2) $2.50 per prescription for a pharmacy that is

not a participating pharmacy.

(b) For years subsequent to 1991. For each year

subsequent to 1991, the administrative allowance

is the allowance applicable to the previous year

increased by the percentage increase in the implicit price deflator for gross national product over

the 12 month period ending with August of the

preceding year as published by the Department of

Commerce rounded to the nearest penny.
174 ● Home Drug Infusion Therapy Under Medicare

(c) Limitation on administrative allowance for

dispensing insulin.

(1)

(2)

Purchase of a 30 day supply. For insulin that

is available without a prescription, the administrative allowance is made for each purchase

of a reasonable quantity, that is, a 30 day

supply.

Exceptions. An administrative allowance is

made for a purchase of a supply of insulin for

fewer than 30 days in the following circumstances (or if other extenuating conditions

exist):

(i) There is a change in the type of insulin the

beneficiary uses or the insulin regimen is

otherwise modifies; or

(ii) If, because of travel plans, the beneficiary

needs to make smaller purchases or forgets to bring along enough insulin for

duration of the trip.

(d) Exception for drugs dispensed for home IV

drug therapy. No administrative allowance is

paid for dispensing a drug that is to be used in

home IV drug therapy. An allowance for dispensing IV drugs is made under the fee schedule

for payment for services related to home IV drug

therapy under subpart J of part 414.

Amount of the Payment Percent

(a)

(b)

Immunosuppressive and home IV drugs. For

drugs related to immunosuppressive drug therapy

dispensed during the first year after a covered

organ transplant and for home IV drugs, the

payment percent equals 80 percent.

Other drugs. The payment percent for covered

outpatient drugs other than the drugs described in

paragraph (a) of this section equals the following:

(1) In 1990 and 1991,50 percent.

(2) In 1992,60 percent.

(3) In 1993 and subsequent years, 80 percent.

Coverage of Home Intravenous Drug Therapy

Services (54 F.R. 37422)

These proposed regulations would expand coverage

under Medicare Part B to include coverage of home IV

drug therapy services as authorized by section 203 of the

Medicare Catastrophic Coverage Act of 1988. They

include requirements for certification and for review and

approval of the need for the covered services by a peer

review organization, and they place limits on acceptance

of and payments for certain patient referrals for covered

home IV drug therapy services as specified in the statute.

Home IV drug therapy services are covered by Medicare

beginning January 1, 1990.

Basic Rule

Under sections 1834(d) and 1861(jj), Medicare Part B

pays for home intravenous drug therapy services furnished by a qualified home intravenous drug therapy

provider (see part 485, subpart C of this chapter) or by

others under arrangements made by the qualified home IV

drug therapy provider with them, to a patient who is under

the care of a physician, in a place of residence used as the

beneficiary’s home and under a plan of care established

and periodically reviewed by the beneficiary’s referring

physician.

Definitions

For purposes of this subpart:

Home intravenous drug therapy provider or “home

IV provider” means an entity that provides home IV drug

therapy services, has been certified as meeting the

conditions of participation of part 485, subpart C of this

chapter, and has a provider agreement with HCFA.

Home intravenous drug therapy services or “home

IV services” means nursing, pharmacy and related

services (including medical supplies, equipment, intravenous fluids only when used as diluents for covered home

IV drugs, and delivery services) necessary to conduct an

intravenously administered regimen safely and effectively in conjunction with the use of a covered home

intravenous drug. These services are furnished to an

individual who is under the care of a physician, in a place

of residence used as the individual’s home, by a qualified

home IV provider (or by others under arrangements), and

under a plan established and periodically reviewed by the

referring physician.

IV stands for intravenous.

Place of residence used as the individual’s home is

a place in which the beneficiary normally resides and is

not an institution or facility that is defined in section

1861(e)(l), 1819(a) or 1919(a) of the Act.

Referring physician means the physician who prescribed the covered home intravenous drug for which the

services are to be provided or who established the plan of

care for the services or both.

Home IV Drug Therapy Services

(a) Individual services. Particular services included

in the term “home intravenous drug therapy

services’ that are covered under this subpart are

limited to the nursing services and pharmacy

services described in 485.135 and 485.140, respectively, of this chapter and related services described in paragraph (b) of this section that are

necessary for the safe and effective administration

of a covered home IV drug. Separate payment may

not be made for any of these services furnished to
Appendix C-Home lntravenous Drug Therapy:ProposedRegulations Under the Medicare Catastrophic Coverage Act . 175

(b)

(c)

a patient receiving covered home intravenous drug

therapy services.

Related services and supplies. The home IV

provider must furnish the following if they are

necessary for the safe and effective administration

of a covered home IV drug:

(1)

(2)

(3)

(4)

(5)

Medical supplies;

Intravenous fluids for use as diluents for

covered home IV chug;

Training of the patient or his or her caregiver

in the techniques of IV drug therapy;

Equipment such as IV poles and infusion

pumps; and

Delivery of medical items and supplies.

Prohibited payment. Payment may not by made

to a home IV provider for covered home IV drug

therapy services unless the home IV provider

furnishes the covered home IV drug either directly

or under arrangements.

Payment Limitations Concerning Certain

Patient Referrals

(a) Ownership and compensation rules. Payment

may not be made to a home IV therapy provider for

the home IV drug therapy services furnished to a

beneficiary if that beneficiary’s referring physician

or an immediate member of the referring physician’s family has an ownership interest in the

provider or receives compensation from the provider unless an exception under paragraph (b)

through (e) of this section applies. For purposes of

this paragraph, an immediate member of the

family includes the physician’s spouse; natural

and adoptive parents, natural and adopted children; natural, adopted, and adoptive siblings;

stepparents, stepchildren, and step siblings; fathersin-law, mothers-in-law, brothers-in-law, sisters-inlaw, sons-in-law, and daughters-in-law; and grandparents and grandchildren.

(b) Exception applying to limitation on ownership.

(1)

(2)

(3)

Payments may be made if the ownership

interest is the ownership of stock in the home

IV provider that is traded over a publicly

regulated exchange and purchased on terms

generally available to the public.

Payments may be made if the provider is the

sole home IV drug therapy provider in a rural

area.

For purposes of paragraph (b)(2) of this

section, a rural area is one that is not an

urbanized area (as defined by the Bureau of the

Census) and that is designated by the Secretary either:

(i) As an area with a shortage of personal

(c)

(d)

(e)

health services under section 1302(7) of

the Public Health Service Act, or

(ii) As a health manpower shortage area

described in section 332(a)(l)(A) of the

Act because of its shortage of primary

medical care manpower.

(4) For purposes of paragraph (b)(2) of this

section, a sole home IV drug therapy provider

in a rural area is one that is approved as such

by HCFA after the provider:

(i) Designates a particular area;

(ii) Shows that no other home IV provider

furnishes services within that area [and]

(iii) Shows that there are no physicians without an ownership interest in the provider

available to perform certification and

recertification and to write plans of care.

Exception applying to limitation on compensation. Payment may be made under this section if

the compensation is reasonably related to items or

services actually provided by the physician and

does not vary in proportion to the number of

referrals made by the referring physician. This

exception does not apply if the compensation is for

direct patient care services.

Exception applying to uncompensated officer

or director. Payment maybe made if the referring

physician’s or immediate family member’s ownership or financial relationship with the provider is

as an uncompensated officer or director of the

provider.

Exceptions applying to instances in which there

is not substantial risk of program abuse. Payment may be made under this part in those cases in

which the Secretary has specifically determined

that the nature of the ownership or compensation

does not pose a substantial risk of program abuse

involving the following:

(1) Space rental. For purposes of this paragraph,

the term ‘‘fair market value” means the value

of the rental property for general commercial

Purpose (not taking account of its intended

use), but it is not adjusted to reflect the

additional value the prospective lessee or

lessor value would attribute to the property as

a result of its proximity or convenience to the

lessor where the lessor is a potential source of

patient referrals to the lessee. As used in

section 1834(d) of the Act, neither “ownership” nor “compensation” includes payments made by a lessee to a lessor for the use

of premises, as long as:

(i) The lease agreement is set out in writing

and signed by the parties;

(ii) The lease specifies the premises covered
176. Home Drug Infusion Therapy Under Medicare

by the lease;

(iii) If the lease is intended to provide the

lessee with access to the premises for

periodic intervals of time, rather than on

a full-time basis for the term of the lease,

the lease specifies exactly the schedule of

such intervals, their precise length, their

periodicity, and the exact rent for such

intervals;

(iv) The term of the lease is for not less than

1 year; and

(v) The rental charge is consistent with fair

market value in arms-length transactions

and is not determined in a manner that

takes into account the volume or value of

any referrals of business between the

parties for whom the services would be

paid by Medicare or Medicaid.

(2) Equipment rental. For purposes of this paragraph, the term “fair market value” means the

value of the equipment when obtained from a

manufacturer or professional distributor, but it

is not adjusted to reflect the additional value

the prospective lessee or lessor would attribute

to the equipment as a result of its proximity or

convenience to the lessor where the lessor is a

potential source of patient referrals to the

lessee. As used in section 1834(d) of the Act,

neither “ownership” nor “compensation”

includes payments made by a lessee of equipment to the owner (’ ‘lessor’ of the equipment

for the use of the equipment, as long as:

(i) The lease agreement is set out in writing

and signed by the parties;

(ii) The lease specifies the equipment covered by the lease;

(iii) If the lease is intended to provide the

lessee with use of the equipment for

periodic intervals of time rather than on

a full-time basis for the term of the lease,

the lease specifies exactly the schedule of

such intervals, their precise length, their

periodicity, and the exact rent for such

intervals;

(iv) The term of the lease is for not less than

1 year; and

(v) The rental charge is consistent with fair

market value in arms-length transactions

and is not determined in a manner that

takes into account the volume or value of

any referrals of business between the

parties reimbursed under Medicare.

(3) Personal services and management contracts. For purposes of this paragraph, an agent

of a principal is any person, other than a bona

fide employee, who has an agreement to

perform services for, or on behalf of, the

principal. As used in section 1834(d) of the

Act, neither “ownership” nor “compensation” includes payments made by a principal

to an agent as compensation for the services of

the agent, as long as:

(i) The agency agreement is set out in

writing and signed by the parties:

(ii) The agency agreement specifies the services to be provided by the agent;

(iii) If the agency agreement is intended to

provide for the services of the agent on

periodic, sporadic or part-time basis,

rather than on a full-time basis for the

term of the agreement, the agreement

specifies exactly the schedule of such

intervals, their precise length, the periodicity, and the exact charge for such

intervals;

(iv) The term of the agreement is for not less

than 1 year; and

(v) The aggregate compensation paid to the

agent over the term of the agreement is set

in advance, is consistent with fair market

value in arms-length transactions and is

not determined in manner that takes into

account the volume or value of any

referrals of business between the parties

that is reimbursed under Medicare or any

State health care program.

(4) Employees. As used in section 1834(d) of the

Act, neither “ownership” nor “compensation” includes any amount paid by an employer to an employee who has a bona fide

employment relationship with the employer,

for employment in the provision of covered

items or services. For purposes of this paragraph (f)(4), the term “employee” has the

same meaning as it does for purposes of 42

U.S.C. 410(j)(2), part of the statutory definition of “employee‘‘ in the Federal Insurance

Contributions Act; that is, the common law

employment test.

Physician Certification and Plan of

Treatment Requirements

Medicare Part B pays for home intravenous drug

therapy services only if the referring physician certifies,

and recertifies as required under paragraph (b) of this

section, that the requirements described in paragraphs

(a)(1) through (a)(5) of this section are being met.

(a) Certification: Content. The referring physician

must certify, or recertify if applicable, that:

(1) The home intravenous drug therapy services
Appendix C-Home lntravenous DrugTherapy:Proposed Regulations Under the Medicare Catastrophic Coverage Act . 177

(b)

(c)

(2)

(3)

(4)

(5)

are or were required because the individual

needs or needed the services for the administration of a covered home intravenous drug;

A plan for furnishing the services has been

established by the referring physician and is

reviewed periodically by that physician;

The services are or were furnished while the

individual is or was under the care of a

physician;

The services are furnished in a place of

residence used as the patient’s home; and

For services initiated before January 1, 1993,

a PRO has approved the services in accordance

with part 466, subpart E, of this chapter.

Recertification. The referring physician must

recertify that the requirements in paragraph (a) of

this section are still met at least every 30 days.

Plan of care requirements.

(1)

(2)

(3)

Establishment. The referring physician must

establish and sign the plan of care and consult

as necessary with the home IV provider nurse

or pharmacist before the home IV Therapy

begins in accordance with sections 485.135

and 485.140 of this chapter.

Content. The plan of care must contain at least

the information required in section 485.120 of

this chapter.

Review. The physician must review and sign

the plan of care at least every 30 days.

PRO Review of Home IV Drug Therapy Services

(a)

(b)

Statutory basis. Sections l154(a)(16) and

1835(a)(2)(G) of the Act require PROS to review

all home intravenous (IV) drug therapy services

before these services begin; or, in the case of

services first initiated on an outpatient basis,

within one working day (other than in exceptional

circumstances) of the date of initiation of the

services.

Applicability. The regulations in this subpart

apply to reviews, conducted by a PRO and its

subcontractors, of home IV drug therapy services

furnished, or proposed to be furnished to all

Medicare beneficiaries other than those beneficiaries enrolled in HMOs [health maintenance

organizations] or CMPs [competitive medical

plans] that contract with HCFA on a risk-basis as

described in subpart C of 42 CFR part 417.

Effective Dates-All home IV drug therapy services

intended to be furnished to Medicare beneficiaries on or

after January 1, 1990 are subject to the PRO review

requirements of this subpart.

Definitions-As used in this subpart:

Outpatient basis means the patient receives services

other than as an inpatient of a hospital.

Scope of PRO Review—

(a)

(b)

General rule. After a PRO receives a request for

review of home IV drug therapy services from

either the referring physician or the health care

facility, the PRO must determine (in accordance

with the terms of its contract) whether the home IV

drug therapy is reasonable, appropriate, and necessary for the treatment of the illness or injury. This

review includes a determination that the intravenous route of administration is the correct route of

administration and that the home IV drug therapy

services meet professionally recognized standards

of care.

Coordination of sanction activities. In implementing review of home IV drug therapy services,

PROS must carry out the responsibilities specified

in subpart C, part 1004, chapter V of this title,

regarding imposition of sanctions on health care

facilities and practitioners who violate their statutory obligations under Section 1156 of the Act. For

example, a PRO is to refer to the HHS [U.S.

Department of Health and Human Services] Office

of Inspector General a case involving a physician

who exhibits a pattern of not correctly monitoring,

by appropriate laboratory tests, the administration

of a drug.

Notification of PRO Review Procedures-

(a)

(b)

Criteria. The PRO must distribute, at no charge,

the criteria/quality screening guidelines to be used

in screening cases, at a minimum, to all affected

health care facilities and medical societies in the

State.

Information required. Each PRO must give

timely written notification to health care facilities

and physicians in its State the following information:

(1)

(2)

(3)

(4)

(5)

Date. The date upon which the PRO plans to

begin review of home IV drug therapy services.

Manner. The manner in which the referring

physician or health care facility is to seek PRO

review.

Required information. The information to be

furnished to the PRO by the physician and/or

health care facility and the need for expediency in responding to PRO questions.

Validation and quality review. The validation and quality review that the PRO may

conduct on a sample of the cases after the

services are furnished in the home.

Financial liability. A general statement about
178. Home Drug Infusion Therapy Under Medicare

financial liability for charges related to home

IV drug therapy services that are found to be

not reasonable or medically necessary and a

statement that no claims will be paid without

PRO approval.

Responsibilities of Physicians and Health Care

Facilities—

(a)

(b)

Physicians. The referring physician must cooperate (in addition to the requirements in 466.78) in

the

(1)

(2)

conduct of PRO review as follows:

The physician must, in accordance with PROissued procedures, either seek PRO prior

authorization for the drug he or she proposes

to have administered intravenously at home or

assist in providing necessary information in

support of a health care facility that seeks PRO

approval.

The physician must furnish relevant medical

records, upon request, to the PRO for any of

the reviews described in this subpart.

Health care facilities.

(1)

(2)

(3)

(4)

In addition to the general requirements for

health care facilities set forth in 466.78, the

health care facility must cooperate in the

conduct of PRO review (in accordance with

the regulations in this part and PRO-issued

procedures) by obtaining the authorization

number provided by the PRO:

(i) Before beginning the administration of an

IV drug in the patient’s home, except in

cases where the drug is to be started on an

outpatient basis on a weekend (i.e., a

non-workday), the authorization must be

obtained the first working day thereafter;

and

(ii) In certain cases, before continuation of

home IV drug therapy that the PRO has

previously approved as described in 466.216

(C) and (d).

Health care facilities must maintain a written

agreement with the appropriate PRO.

The health care facility must, in accordance

with PRO-issued procedures, either seek PRO

approval of the IV drug therapy services

proposed to be administered at home or assist

in providing necessary information in support

of a referring physician that seeks PRO

approval.

The health care facility must transfer relevant

medical records (including the plan of care

described in 424.28(c)), upon request, to the

PRO for any of the reviews described in this

subpart.

Lack of Cooperation by a Health Care Facility or

Physician—If a health care facility or physician fails to

comply with the requirements for review set forth in this

subpart, the PRO may determine that the health care

facility or physician has failed to comply with the

requirements of subpart C, part 1004, chapter V of this

title concerning failure by providers or practitioners to

meet statutory obligations under section 1156 of the Act

and may report the matter to the Office of Inspector

General.

PRO Designation—

(a)

(b)

(c)

When-home IV drug therapy is proposed for a

currently hospitalized inpatient, the referring physician or health care facility must contact, for prior

authorization, the PRO with whom the hospital has

an agreement.

When home IV drug therapy is proposed for a

patient who has had the drug started on an

outpatient basis, the physician or health care

facility must contact, for authorization, the PRO

for the State in which the home IV drug therapy

provider is located.

For all other reviews, the PRO for the State in

which the home IV drug therapy provider is

located will conduct the review.

PRO Approval—

(a) Before approving the home IV drug therapy

services, the PRO must assured:

(1)

(2)

(3)

(4)

That the patient’s condition is such that

inpatient hospitalization is not justified either

(i) As a continuation of an existing hospitalization; or

(ii) As a medically necessary and appropriate

admission;

Orally, in writing, or from documentation (or

any combination of these three), that the

patient meets the selection criteria outlined in

485.115 of this subpart;

That the patient or caregiver has been or will

be sufficiently trained as to how to administer

the drugs safely and effectively in the home;

and

That the patient or caregiver has or will

independently administer(e-d) intravenously at

least one dose of the drug under supervision.

(b) The PRO must determine that:

(1)

(2)

The plan of care, executed by the referring

physician, has enough information to support

the coverage of home IV drug therapy services;

The drug is being used for one of the stated

indications listed in a Federal Register notice

issued by the Secretary;
Appendix C—Home Intravenous Drug Therapy: Proposed Regulations Under the Medicare Catastrophic Coverage Act . 179

(c)

(d)

(3)

(4)

(5)

(6)

(7)

(8)

The drug is medically indicated for the treatment of the patient’s condition;

The dosage is correct (e.g., adjusted for height

and body weight);

Appropriate diagnostic studies (e.g., culture

and sensitivities, kidney function tests) have

been performed and will be performed as

appropriate while the patient is receiving the

therapy;

Other appropriate periodic monitoring has

been and will be performed;

The drug is not contraindicated (e.g., based

upon abnormal laboratory findings, or drug

interactions); and

The home IV drug therapy services meet

professionally recognized standards of care.

The PRO must also determine that the intravenous

route of administration is the only route of

administration that will be effective.

In performing review, the PRO uses review

coordinators to compare the facts about the

individual case to the criteria/screening guidelines

developed by HCFA, the PRO, or both.

(1)

(2)

(3)

(4)

If the case meets the criteria/guidelines, the

review coordinator issues a PRO approval

number.

If the case does not meet the criteria/

guidelines, the review coordinator refers the

case to a PRO physician.

The PRO physician review either approves the

case (using a PRO approval number) or

questions the case.

If the case is questioned by the PRO physician,

the physician who prescribed the home IV

drug therapy and the health care facility are

immediately given an opportunity to discuss

the case.

(i)

(ii)

(iii)

(iv)

The PRO attempts to contact either the

referring physician or health care facility.

The referring physician may discuss the

case with a PRO physician.

The health care facility may discuss the

case with a PRO representative. If, however, the health care facility designates a

physician representative, the physician

may also discuss the case with a PRO

physician.

For potential quality problems, the PRO

follows the timeframes outlined in its

contract with HCFA.

Timing of Review—

(a) Prior review of continuation of inpatient hospital therapy.

(1) The PRO is required, for all IV drug therapy

(2)

(3)

(4)

continued at home after a hospital stay, to

authorize such use before hospital discharge.

The review must be requested by the referring

physician or the health care facility in accordance with PRO-issued instructions.

The PRO will follow the review process

outlined in 466.214(c).

The PRO must complete the review within one

working day of receipt of a request for review.

(i)

(ii)

(iii)

The date of the request for review is

considered to be the date upon which the

PRO receives all of the information it

needs to complete the review.

In this timeframe, the PRO must give the

health care facility and referring physician an opportunity to discuss the case as

described in 466.214.

Failure of the health care facility and

referring physician to discuss the case

within the time allowed is not a basis that

will prevent the PRO form making its

determination base upon the information

in its possession.

(b) Initial review of IV drugs started on an outpatient basis. In the case of a patient whose IV drug

therapy services are initiated on an outpatient

basis, the referring physician or health care facility

will request PRO approval no later than the first

working day on which the home IV drug therapy

services are prescribed.

(1)

(2)

(3)

(4)

(5)

The PRO has 8 working hours in which to

complete its review after receipt of a request

for review from the referring physician or

health care facility.

The date the PRO receives the request for

review is the date on which the PRO receives

all the information it needs to complete the

review.

PRO review follows a request from the

referring physician or health care facility that

is made in accordance with PRO-issued instructions.

The PRO will follow the review process

outlined in 466.214(c).

The PRO must complete its review within 1

working day of initiation for the home IV drug

services.

(i)

(ii)

This timeframe includes the time the PRO

must give the health care facility and

physician to discuss the case as described

in 466.214.

If the health care facility and physician do

not take advantage of the opportunity to

discuss the review within the time allowed

the PRO may make its determination
180. Home Drug Infusion Therapy Under Medicare

(c)

(d)

based upon the information in its possession.

Subsequent reviews for continuation of drugs.

In accordance with the PRO’s prior approval,

when drugs are to be continued for a period of time

beyond the date or number of days approved by the

PRO, the PRO will periodically review to determine that coverage of the home IV drug therapy

services continues to be appropriate in accordance

with the requirements set forth in 466.214(a) and

(b) of this subpart.

(1)

(2)

(3)

If home IV drug therapy is planned to continue

for a time past the date the PRO has indicated,

the physician or health care facility must

request PRO review no less than 3 working

days before the expiration of the current PRO

approval.

The PRO follows the process outline in

466.214(c).

The PRO must complete subsequent reviews

within 3 working days for the request.

(i) In this timeframe, the PRO must give the

health care facility, if applicable, and

physician an opportunity to discuss the

case as described in 466.214.

(ii) If the health care facility and physician do

not take advantage of the opportunity to

discuss with the tie allowed, the PRO may

make its determination based upon the

information in its possession.

Prior review of change in drug. When the

referring physician proposes a change to the IV

drug therapy, the referring physician or the health

care facility will request PRO approval of the

revision in therapy within one working day of

initiation of the change.

(1)

(2)

(3)

The referring physician or health care facility

must request PRO review in accordance with

PRO-issued instruction.

The PRO will follow the review process

outlined in 466.214(c).

The PRO will complete its review within three

working days of the request.

(i) In this timeframe, the PRO must afford

the health care facility and referring physician an opportunity to discuss the case

as described in 466.214.

(ii) If the health care facility and referring

physician do not take advantage of the

opportunity to discuss the case within the

time allowed, the PRO will make its

determination based upon the information

in its possession.

(e) Retrospective reviews. For retrospective reviews,

the PRO must adhere to the timing of review

requirements found in its contract with HCFA.

Notification—

(a) The PRO must, within the timeframes given in

466.216, provide notification if its determination

as follows:

(1) The PRO notifies the health care facility and

referring physician by telephone as to whether

it has determined that:

(i)

(ii)

(iii)

(iv)

Services are reasonable, appropriate, and

medically necessary. The PRO issues an

approval number and informs the health

care facility, if applicable, and referring

physician of the date by which review

and subsequent approval must be requested for continuation of the IV drug

therapy;

Services are not reasonable, appropriate,

or medically necessary;

Services are medically necessary but

neither the patient nor caregiver meets

the selection criteria; or

The patient should receive the services if

(b)

another setting.

(2) If the PRO does not authorize the services

because they are not reasonable, appropriate

and medically necessary in the home setting,

within 1 working day of the determination it

must, in accordance with the requirements of

section 466.94(c), notify in writing:

(i) The beneficiary;

(ii) The referring physician;

(iii) The health care facility, and

(iv) The fiscal intermediary.

If the PRO determines that the services do not meet

professionally recognized standards of care, the

PRO will notify the referring physician and health

care facility in accordance with the quality intervention plan in the PRO’s contract.

Retrospective Reviews-

(a)

(b)

(c)

Random sampling. The PRO must periodically

review a sample of cases to determine that the

home IV therapy services meet professionally

recognized standards of care and that the conditions in 466.214 are met.

Retrospective review of unapproved cases. On

a retrospective, prepayment (and on an exception

basis, postpayment) basis, the PRO reviews (upon

the request of the physician or health care facility)

any claims for the home IV drug therapy services

for which PRO review was required but never

completed and makes a determination in accordance with 466.214.

Validation reviews. The PRO in the State where

the home IV drug therapy provider is located must
Appendix C-Home lntravenous Drug Therapy:ProposedRegulations UndertheMedicareCatastrophicCoverage Act ● 181

conduct a validation review of a sample of cases in

which approval for home IV drug therapy services

under this subpart was granted by telephone tier

the PRO considered medical information by telephone but did not review actual medical records.

(1)

(2)

(3)

The PRO must be assured that information

provided to the PRO was accurate and that the

home IV drug therapy services met professionally recognized standards of care.

If inaccurate information was given to the

PRO, the PRO must deny payment for the

services if they are found to be uncovered

based upon the correct information.

As a result of this review, the PRO may decide

that future medical information must be submitted in writing.

Liability and Sanctions for Unreviewed Cases—

(a)

(b)

(c)

(d)

Payment contingent upon approval. No payment will be paid for any claim where the PRO has

not approved the services for payment.

Failure of PRO to complete review. If, because

of a PRO administrative error, the review is not

completed within the timeframes outlined in

466.216, the PRO still must complete the review

and issue an approval number or a notice denying

the services.

Financial liability. Financial liability is determined in accordance with provisions of sections

1842(1) and 1879 of the Act and 405.330 through

405.336 of this chapter.

Corrective action.

(1)

(2)

If the review is not completed timely, whether

or not the PRO determines that the home IV

drug therapy is appropriate and the physician

or health care facility (or both) are the cause

of the problem (including failure to make the

request on a timely basis), the PRO must take

whatever corrective actions are necessary to

ensure that future cases are reported to the

PRO for review within the outlined timeframes.

If the information given over the telephone is

found to be inaccurate or misleading, the PRO

may take appropriate corrective actions.

Reconsiderations and Appeals Reconsiderations and

appeals are available under part 473 of this chapter for all

PRO initial denial determinations.

Location for Submitting Requests for Reconsideration—

(c) Expedited reconsideration. A request for an

expedited reconsideration must be submitted directly to the PRO if the denial is a result of:

(1) Preadmission/preprocedure review; or

(2) Review of home intravenous drug therapy

services before the initiation of or during the

period in which the beneficiary is still receiving the services.

Time Limits for Issuance of the Reconsidered

Determination—

(a) Beneficiaries. If a beneficiary files a timely

request for reconsideration of an initial denial

determination, the PRO must complete its reconsidered determination and send written notice to

the beneficiary within the following time limits:

(1) Within 3 working days after the PRO receives

the request for reconsideration if:

(i)

(ii)

The beneficiary is still An inpatient in a

hospital for the stay in question when the

PRO receives the request forreconsideration;

or

The initial determination relates to home

intravenous drug therapy services for

which approval was denied and a request

was submitted timely for an expedited

reconsideration.

(3) Within 30 working days after the PRO receives the request for reconsideration if:

(i)

(ii)

(iii)

The initial determination concerns ambulatory or noninstitutional services;

The beneficiary is no longer an inpatient

in a hospital or SNF [skilled nursing

facility] for the stay in question or no

longer receives home intravenous drug

therapy services for which the PRO

issued a denial determination; or

The beneficiary does not submit a request

for expedited reconsideration timely [sic].

Payment for Home Intravenous Drug Therapy

Services (54 F.R. 46938)

This proposed rule sets forth the methodology for

payment for home IV drug therapy services. This proposal

would implement the provisions of section 1834(d) of the

Social Security Act as added by section 203(c)(1) of the

Medicare Catastrophic Coverage Act of 1988. Coverage

of and payment for home IV drug therapy services under

Part B of Medicare would be implemented on January 1,

1990.

Basis and Scope

(a) Statutory basis. This subpart is based on sections

1834(d)(l) and (2) of the Act which, respectively:

(1) Provide that payment for home IV drug

therapy services is the lesser of the actual

charges or a fee schedule amount; and

(2) Require the Secretary to establish by regulation a per diem fee schedule for those services.
182. Home Drug Infusion Therapy Under Medicare

(b) Scope. This subpart sets forth the methodology

used to determine the per diem fee schedule

amount for home IV drug therapy services, which

are covered under Medicare beginning on January

1, 1990.

Determination of Amount Payable

(a)

(b)

(c)

(d)

(e)

General rule. Medicare payment for home IV

drug therapy services, as defined in section 410.203

of this chapter, is made at 100 percent of the lesser

of:

(1) The actual charge; or

(2) The applicable per diem fee schedule amount

and any applicable additional allowances determined under this subpart.

Separate fee schedules. Two separate fee schedule amounts are calculated; one for pain management drug therapy and one for antibiotic and other

drug therapies.

Basis for calculating fee schedule amounts. The

applicable fee schedule amount for each type of

drug therapy is the per diem allowance for each of

the home IV drug therapy service components

plus, as appropriate, additional allowances applicable in special circumstances.

Service components. HCFA calculates a per diem

fee schedule allowance for each of the following:

(1) Pharmacy services.

(2) Pharmacy supplies.

(3) Pharmacy delivery.

(4) Nursing services and supplies.

(5) Other equipment.

Special circumstances. HCFA calculates additional allowances for each of the following:

(1) Patient education and counseling at the time

IV drug therapy begins in the home

(2) Multiple IV drug regimen.

(3) New drug introduced into existing drug regimen.

Calculation of Per Diem Fee Schedule Allowances

for Calendar Year 1990

(a) Pharmacy services.

(1)

(2)

An average hourly pharmacy rate is calculated

by weighting an average hourly pharmacist

rate based on direct and indirect costs and an

average hourly pharmacy technician rate based

on direct and indirect costs by the estimated

time spent by each in drug preparation.

A per dose cost of preparation is calculated for

each type of drug by multiplying the average

time spent in preparing the drug and evaluating patient outcome by the average hourly

pharmacy rate.

(3) A per diem cost of preparation is calculated for

each type of drug by multiplying the per dose

cost for the drug by the average number of

doses per day.

(4) The per diem allowance for pharmacy services

for each type of drug therapy is equal to the per

diem cost of preparing that type of drug.

(b) Pharmacy supplies.

(1)

(2)

(3)

A per dose cost of pharmacy supplies for each

type of drug therapy is calculated by adding

the cost of all supplies needed for that type of

therapy.

A per diem cost of pharmacy supplies for each

type of drug therapy is calculated by multiplying the per dose cost by the average number of

doses per day.

The per diem allowance for pharmacy supplies

for each type of drug therapy is equal to the per

diem cost for supplies for that type of drug

therapy.

(c) Pharmacy delivery.

(d)

(1)

(2)

(3)

(4)

A per trip nonlabor cost of delivery of drugs is

calculated by multiplying the estimated average mileage per trip by the Federal mileage

allowance divided by the estimated average

number of deliveries per trip.

A per trip labor cost of delivery of drug is

calculated by multiplying the estimated average travel time for each delivery by an average

hourly salary rate for a delivery person based

on direct and indirect costs.

A per diem cost of delivery for each type of

drug is calculated by adding the per trip

nonlabor and labor costs and multiplying the

result by the estimated number of trips per day

for each type of drug.

The per diem allowance for pharmacy delivery

for each type of drug therapy is equal to the per

diem cost of delivery for that type of drug

therapy.

Nursing services and supplies.

(1)

(2)

(3)

A per visit cost for patient care time is

calculated by multiplying the average number

of hours spent with a patient in each visit by

the average hourly salary for a nurse based on

direct and indirect costs.

A per visit cost for travel time is calculated by

multiplying the average travel time per patient

by the average hourly salary for a nurse based

on direct and indirect costs.

The per visit costs calculated in paragraphs

(d)(1) and (d)(2) of this section are adjusted for

area differences in wage levels by a factor

(established by HCFA) reflecting the relative

home health agency wage level in the geo-
Appendix C-Home lntravenous Drug Therapy:Proposed Regulations Under the Medicare Catastrophic Coverage Act . 183

(e)

(4)

(5)

(6)

graphic area of the home IV drug therapy

provider compared to the nation average home

health agency wage level.

A per visit cost for travel is calculated by

multiplying the estimated average mileage per

visit by the Federal mileage allowance.

A per visit cost of nursing supplies is calculated by adding the cost of supplies used in

each visit.

The per diem allowance for nursing services is

calculated by adding the separate adjusted per

visit cost for direct patient care time and travel

time and the per visit costs for travel and

nursing supplies and dividing by the average

number of days between visits.

Other equipment. The per diem allowance for

other equipment is the separate per diem cost of the

equipment not related to either pharmacy or

nursing services calculated for each type of drug

therapy by dividing the cost of the equipment

necessary for the therapy by the average useful life

of the equipment.

[Proposed actual amounts for all above services for

1990 were $45.44 per day for antibiotic therapy and

$31.63 per day for pain management therapy.]

Calculation of Additional Allowances for

Calendar Year 1990

(a)

(b)

Patient education and counseling at the time IV

drug therapy begins in the home. The amount of

the allowance depends on whether the patient had

begun IV drug therapy as a hospital inpatient.

(1)

(2)

Patient begins IV drug therapy while a

hospital inpatient. If the patient begins IV

drug therapy as a hospital inpatient, the

allowance is equal to two times the per visit

cost for nursing services as a calculation by

adding the per visit costs determined in

414.588 (d)(1) through (d)(4).

Patient begins IV drug therapy outside the

hospital inpatient setting. If the patient

begins IV drug therapy in any setting other

than that of a hospital inpatient, the allowance

is equal to three times the per visit cost for

nursing services as calculated by adding the

per visit costs determined in 414.558 (d)(1)

through (d)(4).

Multiple IV drug regimen. A per diem allowance

is made for the additional pharmacy services and

supplies, nursing services, and other equipment

needed for a patient who receives concurrently

more than one IV drug. The per diem allowance is

equal to the sum of the following:

(1)

(2)

(3)

50 percent of the applicable per diem allowance for pharmacy services as calculated in

414.558(a).

100 percent of the applicable per diem allowance for pharmacy supplies as calculated in

414.558(b).

100 percent of the applicable per diem allowance

- for other equipment & calculated in

414.558(e).

(c) Nursing services for initial dose of new drug—

introduced into the drug regimen:

(1)

(2)

Applicability. This allowance is made for

nursing services related to one nursing visit for

the initial dose when a prescription change

introduces an additional covered home IV

drug to the patient’s drug regimen or substitutes a new covered home IV drug for one

already being used.

Amount. This allowance is equal to 50 percent

of the per visit costs for nursing services as

calculated by adding the per visit costs determined in section 414.558 (d)(1) through

(d)(4).

Calculation of Per Diem Fee Schedule

and Additional Allowances for Calendar Years

After 1990

The per diem fee schedule and additional allowances

for calendar years after 1990 are periodically recalculated

to take into account increases in costs of nursing and

pharmacy services, supplies, and delivery, and other

equipment.

Conditions of Participation for Home

Intravenous Drug Therapy Providers

(54 F.R. 37220)

This proposed rule sets forth the conditions of participation that an entity would be required to meet in order to

qualify as a home intravenous drug therapy provider. This

proposal would implement the provisions of section

1861 (jj)(3) of the Social Security Act, which was added

by section 203(b) of the Medicare Catastrophic Coverage

Act of 1988. An entity that meets these conditions of

participation would be eligible for payment from Medicare for covered home IV drug therapy services furnished

to Medicare beneficiaries.

Basis and Scope

This subpart sets forth the conditions that entities must

meet to be approved for participation in Medicare as home

IV drug therapy providers under section 1861(jj) of the

Act and part 489 of this chapter.
184. Home Drug Infusion Therapy Under Medicare

Definitions

As used in this subpart unless the context indicates

otherwise, “home intravenous (IV) drug therapy provider’ “home IV provider” or “provider” means an

entity that:

(a) Incapable of providing covered home IV drugs,

nursing and pharmacy services, and other services

as are necessary for the administration of home IV

drug therapy; and

(b) Meets all the requirements of this subpart.

Condition of Participation; Compliance With

Federal, State, and Local Laws

The home IV provider and all personnel who furnish

services must be in compliance with applicable Federal,

State, and local laws and regulations.

(a)

(b)

(c)

Standard: Compliance with Federal laws. The

home IV provider must be in compliance with

applicable Federal laws related to the health and

safety of patients.

Standard: Licensure of home IV provider. If

State or local law requires licensing, the home IV

provider must be currently licensed or approved as

meeting the standards established for licensure.

Standard: Licensure of personnel. Personnel

who provide services, including individuals who

provide services under arrangements with the

home IV provider, must be licensed, registered,

certified, or meet other applicable standards in

accordance with applicable State and local laws.

Condition of Participation: Governing Body and

Administration

(a) Standard: Governing body. A home IV provider

must have either:

(1) A governing body that assumes full legal

(b)

(c)

responsibility for determining, implementing,

and monitoring policies governing all operations of the home IV provider; or

(2) Individuals who are legally responsible for the

conduct of the home IV provider and who

carry out the governing body functions that are

specified in this section.

Standard: Disclosure of ownership. The home

IV provider must comply with the provisions of

subpart C of part 420 of this chapter, which require

health care providers and fiscal agents to disclose

certain information about ownership and control.

Miscellaneous reporting. The home IV provider

must furnish information relevant to, and participate in, surveys and studies concerning cost-

(d)

(e)

(f)

findings or other issues relating to the efficient

administration of the home IV therapy benefit as

requested by the Secretary under section 1861(jj)(3)(x)

of the Act.

Standard: Chief executive officer. The governing body must appoint a chief executive officer

who meets the following conditions:

(1) Assumes responsibility for the overall management of the facility under the authority

delegated by the governing body.

(2) Assumes responsibility for the day-to-day

operation of the home IV provider.

Standard: Patient care policies. The home IV

provider must have written patient care policies

that govern the services it furnishes. The patient

care policies must include the following:

(1)

(2)

(3)

(4)

(5)

(6)

A description of the services furnished by the

home IV provider’s employees and those

furnished under arrangements.

The diagnostic criteria that identify the patients for whom the services are designed.

Provisions for accepting only those patients

whose needs can be met by the services it

furnishes.

Procedures for the acceptance of a referral,

including the assignment of appropriate staff

to conduct a timely assessment of the patient’s

medical and psychological readiness for home

IV drug therapy services.

Procedures for quickly notifying the referring

physician if the patient does not meet the home

IV provider’s admission criteria.

Procedures for notifying the referring physician of incidence of phlebitis, IV infiltration,

or site infection that occurs after the provider

begins furnishing home IV drug therapy

services.

Standard: Contracted services and professional

management responsibility.

(1) The home IV provider must:

(2)

(i) Retain professional and administrative

responsibility for and control and supervision of contracted services; and

(ii) Ensure that the services are furnished:

(A) In a safe and effective manner by

nurses or pharmacists meeting the

qualifications of this subpart; and

(B) In accordance with the patient’s plan

of care and other applicable requirements of this subpart.

With each contractor that provides arranged

services, the home IV provider must have a

legally binding written agreement that meets

at least the following requirements:

(i) Identifies the services to be provided.
Appendix C-Home lntravenous Drug Therapy: ProposedRegulations UndertheMedicareCatastrophic CoverageAct ● 185

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

Specifies that contracted services are

provided only if directly authorized by

the home IV provider.

Describes the manner in which the

contracted services are coordinated, supervised, and evaluated by the home IV

provider.

Delineates the roles of the home IV

provider and the contractor in the patient care process.

Provides for the preparation of patient

records with progress notes and observations and for the prompt incorporation

of the patient records into the clinical

record of the home IV provider.

Provides that the requirements for the

services furnished under arrangements

and personnel who furnish them are the

same as for the services furnished directly by the home IV provider and the

personnel who furnish them.

Specifies the financial arrangements

that provide for payment to the contractor by the home IV provider for the

provision of covered services.

Specifies that a contractor that furnishes

services under arrangements may not

bill the patient or Medicare for covered

services.

Condition of Participation: Patient Selection

After a patient’s referring physician requests home IV

drug therapy, the home provider makes an assessment of

each patient and his or her needs. For hospital inpatients,

the home IV provider must make this assessment prior to

discharge. The home IV provider furnishes services only

to patients whose needs can be met by its services.

(a) Standard: Medical criteria. A patient must:

(1)

(2)

(3)

(4)

Be under the care of a licensed referring

physician who either prescribed the home IV

drug or established the plan of care, or both,

and who continually monitors the home IV

drug therapy;

Have a clinical status that allows IV drugs to

be safely administered in the home;

Have venous sites available for peripheral IV

catheter or needle placement or have a central

venous catheter or other central venous access

device; and

Be unable, for medical or therapeutic reasons,

to take the provided medication orally or by

other means less intrusive than IV.

(b) Standard: Nonmedical criteria. A patient must:

(1) Be capable of performing safely selfadministration of drugs and self care after

297-913 0 - 92 - 13

(2)

(3)

(4)

adequate patient education (for example, be

able to learn aseptic technique and heparin

lock maintenance and read and understand the

labeling of the home IV drugs) or have a

primary care giver who can perform these

tasks;

Be motivated to use home IV drug therapy

services;

Be psychologically stable (that is, the prospect

for adherence to a disciplined medical regimen

is realistic); and

Have a home environment that is conducive to

the provision of home IV drug therapy services (that is, a clean home with electricity, a

telephone, running water, refrigeration, and

enough space to support home IV drug therapy

services).

Condition of Participation: Plan of Care

For each patient, the referring physician must establish

and periodically review a plan of care.

(a) Standard: Development of the plan of care. A

plan of care must meet the following requirements:

(1)

(2)

(3)

(4)

(5)

The plan of care is developed by the patient’s

referring physician.

The plan of care is implemented by the home

IV provider.

The plan of care is based on the referring

physician’s initial and ongoing individual

patient assessments.

The plan of care is reviewed by the referring

physician as necessary, but at least once every

30 days.

The plan of care includes at least the following

current information about the patient and the

home IV drug therapy services to be provided:

(i)

(ii)

(iii)

(iv)

(v)

(vi)

The patient’s name, gender, age, and lean

body weight.

A narrative description of the appropriate

diagnoses.

The patient’s drug allergies or sensitivities.

The patient’s current drug therapy, including nonprescription drugs, and home

remedies.

The goal of the provision of home IV

drug therapy services for the patient.

The drugs and method of drug therapy

administration to be furnished by the

home IV provider including:

(A)

(B)

(c)

(D)

Amount of dosage and timing of

administration;

Route of administration, either peripheral or central venous line.

Frequency of IV site monitoring; and

Type of IV equipment, related sup-
186. Home Drug Infusion Therapy Under Medicare

plies and other equipment, and fluids

to be administered.

(vii) Identifying physician information, the

physician’s signature, and the date.

(b) Standard: Referring physician review of plan

or care. The referring physician review of the plan

of care must meet the following requirements:

(1)

(2)

The referring physician reviews the patient’s

process in attaining the objectives of the plan

of care at least every 30 days.

The review is based upon appropriate information provided by health professionals, including information furnished by the registered

nurse and pharmacist employed by the home

IV provider.

Condition of Participation: Central Clinical Records

In accordance with accepted principles of practice, the

home IV provider must establish and maintain a clinical

record for all individuals receiving care and services

including those who are not entitled to Medicare. Each

clinical record must be completely, promptly, and accurately documented, readily accessible, and systematically

organized to ease retrieval and compilation of information.

(a) Standard: Content. Each clinical record is a

comprehensive compilation of information of

medical and other data that must contain sufficient

information to identify the patient clearly and to

justify the diagnosis treatment. Entries in the

clinical record must be made for all services

provided directly or under arrangements. Entries

must be made for each treatment performed and

must be signed by the individual who performs the

services. Documentation on each patient must be

consolidated into one clinical record that must

contain the following information:

(1)

(2)

(3)

(4)

(5)

(8)

(7)

Patient identification data.

The initial patient assessment and subsequent

reassessments.

Current plan of treatment.

Consent and authorization forms.

Past and present pertinent medical history.

Complete documentation of all services provided.

Upon completion of treatment, a summary that

includes a-description of patient status relative

to goal achievement, prognosis, and future

treatment considerations.

(b) Standard: Retention and preservation. The

home IV provider must retain-clinical records for

the appropriate time period as specified in this

paragraph. If the requirements of State law are

used to define the time period for maintaining

clinical records, it must be the law of the State in

which the services were provided to the patient.

(1)

(2)

If the State where the services are furnished

has a law that applies to the provider governing the maintenance of clinical records, the

home IV provider must maintain its clinical

records for the time required by that law.

In the absence of an applicable State law, the

(3)

(4)

home IV provider must maintain clinical

records for the time periods provided under

the appropriate statute of limitations concerning medical malpractice in the State.

If there is no applicable State law or State

statute of limitations concerning medical malpractice, the home IV provider must maintain

clinical records for at least 5 years.

In addition, for services furnished to a minor,

the home IV provider must maintain clinical

records for at least 3 years after the individual

attains the age of majority under State law.

(c) Standard: Protection of information. The home

IV provider must-

(l)-

(2)

Safeguard the clinical record against loss,

destruction, or unauthorized use;

Have procedures to govern the use and re-

(3)

(4)

moval-of records, to ensure release of information only to authorized individuals, and to

ensure that unauthorized individuals cannot

gain access to, or alter, patient records;

Obtain the patient’s written consent before

releasing information not required to be released by law; and

Release original records only in accordance

with Federal or State Laws, court orders, or

subpeoneas.

(d) Standard: Patient access. The home IV provider

must permit each patient of his or her legal

representative to inspector obtain copies of his or

her clinical records within 48 working hours after

the provider receives a written request.

Condition of Participation Core Staff, Core Services,

and Full-time Availability of Patient Core Services

A home IV provider must make all necessary nursing

and pharmaceutical services available 24 hours a day, 7

days a week to meet the reasonable needs of its patients

with respect to home IV drug therapy services.

(a)

(b)

Standard: Core staffing requirements. A home

IV provider must employ directly either a full-time

registered nurse or a full-time register pharmacist.

Core services. A home IV provider must perform

the following oversight and supervisory functions

itself (that is, these function may not be furnished

under arrangements);
Appendix C—Home Intravenous Drug Therapy:ProposedRegulationsUndertheMedicareCatastrophic Coverage Act ● 187

(c)

(1)

(2)

(3)

(4)

Assurance that all patient care related nursing

and pharmacy services, whether furnished

directly or under arrangements, are available

on a 24-hour-a-day, 7-day-a-week basis.

Development and coordination of all activities

of nurses and pharmacists including assuring

that only qualified, properly trained individuals furnish these services.

Necessary consultations and coordination concerning a patient’s plan of care with the

patient’s physician and provision of all patient

laboratory test results.

Conduction a quality assessment and assurance program including drug regime review.

Standard: 24-hour availability of patient care

services.

(1) To meet the needs of patients, a home IV

provider may contract for additional nursing

or pharmacy- services to supplement the services directly furnished by the home IV provider. If services directly furnished under

arrangement [sic], the provider must maintain

professional, financial: and administrative responsibility for the services.

(2) A home IV provider must be able to meet the

following time requirements related to care of

a patient:

(i)

(ii)

(iii)

(iv)

The home IV provider must make routine

or urgently needed nursing, pharmacy,

and related services and home IV drugs

and supplies available 24 hours a day, 7

days a week.

The home IV provider must be accessible

to patients at all times. If a patient or

caregiver telephones the home IV provider with a problem concerning the

administration of a drug or malfunctioning equipment, the provider must be able

to make telephone contact with the patient or caregiver within 10 minutes, and

the provider must be able to resolve that

problem as expeditiously as possible

given the nature of the problem.

In an emergency, the provider must be

able to deliver drugs to the patient at least

30 minutes before the drugs are scheduled for use.

The home IV provider must furnish

services in a manner consistent with

accepted standards of medical practice.

Condition of Participation: Nursing Services

(a) General requirements. The home IV provider is

responsible for furnishing nursing services, directly or under arrangements, that are necessary for

the provision of IV drug therapy services. Persons

furnishing the nursing services either as employees

of the home IV provider or of the organization

under contract with the home IV provider must be

either registered nurses, or in States that permit

such practice, physicians or physicians assistants

under the supervision of a physician. (In such

States, the references in this subpart to a “registered nurse” or “nurse” are read to include

physician assistants.) In addition, the home IV

provider must:

(1) Direct and staff nursing services to ensure that

the needs of its patients are met;

(2) Specify the patient care responsibilities of the

nurses; and

(3) Ensure that the requirements of paragraphs (b)

through (d) of this section are met.

(b) Education and experience.

(1) The home IV provider must ensure that each

nurse who furnished home IV drug therapy

services meets the following requirements for

education. experience, and proficiency:

(i)

(ii)

(iii)

(iv)

Education in the principles and practices

of infusion therapy and cardiopulmonary

resuscitation.

Experience in patient assessment and

infusion therapy.

Proficiency in all clinical aspects of IV

therapy with validated competency in

clinical judgment and practice demonstrated by work experiences. For example, each nurse must be able to access

peripheral veins and must be able to

recognize medication and solution incompatibilities.

Ability to perform the following procedures:

(A)

(B)

(c)

(D)

(E)

(F)

Interpret the physician’s order for IV

therapy and administer IV medications as ordered.

Perform venipuncture and insertion

of all types of needles and catheters

commercially available (excluding the

insertion of subclavian, jugular, and

cut-down catheters).

Prepare IV solutions with the addition of medications in the absence of

admixture services.

Initiate, monitor, and terminate IV

solutions and additives.

Evaluate the effectiveness of the dosage, frequency, and route of administration of IV drugs and the patient’s

adherence to the drug regimen.

Set the flow rates established by the

physician for all IV solutions and

medications.
188. Home Drug Infusion Therapy Under Medicare

(c)

(d)

(e)

(G) Maintain and replace sites, tubing,

and dressing in accordance with established policy.

(H) Draw blood.

(v) Thorough knowledge of and proficient

technical ability in the use of the specific

type of IV equipment to be used by a

particular patient so that the nurse is able

to evaluate IV equipment and identify

when maintenance would be necessary.

(vi) Ability to observe and assess all significant reactions related to IV therapy and

initiate appropriate nursing interventions.

Aseptic practices. Each nurse must follow established infection control and aseptic practices.

Physician notification. All significant findings of

the nurse in the course of delivering home IV

services must be communicated to the physician.

Documentation. Each nurse must document in the

patient’s clinical record his or her action associated

with the preparation, administration, and termination of all aspects of IV therapy.

Condition of Participation: Pharmacy Services

The home IV provider must ensure that a registered

pharmacist is responsible for purchasing, preparation,

safe administration, and clinical monitoring of drugs. The

home IV provider may directly furnish necessary pharmacy services or it may enter into arrangements for the

services.

(a) Standard: Pharmacy services management. The

home IV provider must ensure that necessary

pharmacy services, furnished directly or under

arrangements, are furnished in accordance with the

following requirements:

(1)

(2)

(3)

The policies and procedures of the home IV

provider must ensure that pharmacy practice at

all times is consistent with applicable law and

regulations governing professional licensure

and operation of pharmacies.

The home IV provider must maintain and

make available an up-to-date copy of HCFA’s

list of covered home IV drugs and pharmaceutical references that include official pharmaceutical practice as it relates to patient care.

The home IV provider must maintain patient

profiles that include:

 (i)

(ii)

(iii)

(iv)

The patient’s name, age, and lean body

weight;

The patient’s diagnosis or diagnoses;

Clinical information relating to the patient’s initial and ongoing home IV drug

therapy;

Current drug therapy provided to the

patient including nonprescription and home

remedy products; and

(v) A description of the patient’s drug allergies or sensitivities.

(4) A pharmacist reviews each prescription order

before dispensing a drug to ensure that the

drug is a covered home IV drug and that the

correct drug is dispensed to the patient.

(5) A pharmacist assists the physician in determining the appropriate schedule for monitoring the patient through laboratory testing. This

schedule must include identification of tests to

be performed and the Medicare-approved

laboratory that will perform the tests and

frequency of testing and obtaining the results.

(6) A pharmacist supervises support personnel to

ensure adequate quality of the drugs and

pharmaceutical supplies.

(b) Standard: Storage, equipment, and preparation area.

(1) The IV provider must ensure that drugs,

supplies, and equipment are maintained in the

pharmacy in accordance with the following

procedures:

 (i)

(ii)

(iii)

(iv)

(v)

(vi)

Drugs must be stored separately under

proper conditions of sanitation, temperature, light, moisture, ventilation, and

security.

Areas used in the preparation of sterile

products must be constructed to minimize opportunities for particulate and

microbial contaminations and must be

separate from areas used in preparation of

nonsterile products.

Work surfaces are kept free of equipment, supplies, records, and labels unrelated to the preparation of a given prescription.

Work surfaces and equipment must be

disinfected after the preparation of each

prescription.

Clean work benches or laminar flow

hoods must be used in the preparation of

IV drugs and must be inspected at least

annually in accordance with standard

inspection practice.

Both ingredients and final products must

be inspected for the presence of inappropriate particulate matter or signs of deterioration or microbial contamination. The

equipment necessary for such an inspection must be maintained by the pharmacy.

(vii) Drugs must be kept in a locked storage

area.

(vii) Each dosage unit of both a cytotoxic

drug and a Schedule II controlled drug
Appendix C—Home Intravenous Drug Therapy: Proposed Regulations Under the Medicare Catastrophic Coverage Act . 189

(c)

(2)

(3)

(4)

must be accounted for in a distribution

log.

Unless contraindicated, an appropriate aireliminating filter must be employed in the

home for delivery of IV fluids.

Mislabeled or otherwise unusable drugs must

not be made available for patient use.

Outdated drugs must be destroyed.

Standard: Drug labeling. The label on any IV

drug or solution that has been dispensed to a

patient must contain at least the following information:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

The name, address, and telephone number for

the pharmacy and the telephone number of the

home IV provider if the pharmacy services are

furnished under arrangements.

The dates of both preparation and expiration of

the drug.

The pharmacy’s identifying serial number for

the drug order or prescription.

The full name of both the patient and prescribing physician.

The name of the drug, its strength, and the

amount dispensed.

The directions for use including the scheduled

date, time, and rate of administration, and

appropriate space for the patient or caregiver

to add the date and time the solution is started.

These directions must indicate that the IV

fluids must be completely used or discarded

within 24 hours of mixing or unfreezing a

mixture.

The directions for storage.

Cautionary or accessory labels if appropriate.

The lot number or control number of the batch

from which the drug was obtained.

Condition of Participation: Patient and Caregiver

Evaluations and Instructions

To ensure safe home IV therapy for the patient, a

registered nurse who is proficient in the delivery of home

IV drug therapy services evaluates the patient to determine suitability for the provision of home IV drug therapy

services. If the nurse determines that the patient is suitable

for this therapy and the home IV provider can furnish the

necessary therapy, the nurse trains the patient or caregiver

or both, as appropriate, in providing the therapy and in

proper maintenance of the equipment.

(a) Standard: Patient evaluation. The registered

nurse performs the following activities:

(1) Reviews the referring physician’s medical

orders before evaluating a patient for home IV

drug therapy.

(2) Before accepting the patient for care, evaluates

the patient or caregiver for general compe-

(b)

(3)

(4)

tency and specific comprehension of the

particular IV drug therapeutic procedures to be

used. In making this evaluation, the nurse:

(i)

(ii)

(iii)

Discusses possible complications of the

treatment with the patient or caregiver or

both as appropriate.

Explains and demonstrates home IV drug

therapy procedures to the patient or

caregiver.

After the patient or caregiver demonstrates IV drug therapy procedures, including aseptic techniques, evaluates and

documents the competency and proficiency of the patient or caregiver.

May inspect the patient’s home prior to

hospital discharge to ascertain that there is an

area in the home available for storage of drugs

and supplies and an area available for use of

sterile supplies.

Supervises the patient or caregiver when either

starts the first infusion therapy at home to

verify his or her ability to transfer learning

from the provider setting to the home setting.

Standard: Patient and caregiver education and

instructions. The nurse instructs the patient or

caregiver, as appropriate, in home IV drug therapy

procedures, including aseptic techniques and provides written and illustrated instructions.

(1) The written instructions that are prepared for

each different drug class and administration

route must include the following information:

(i)

(ii)

(iii)

(iv)

(2) The

A step-by-step description of the procedures that the patient or caregiver must

follow in administering an IV drug,

including procedures for any probable

emergency that might arise.

Storage procedures.

Procedures for disposal of drugs and IV

equipment.

A telephone number that would enable a

patient to receive assistance at any time.

nurse must instruct the patient or caregiver about the following:

“(i)

(ii)

(iii)

Methods of detecting early signs and

symptoms of IV-related sepsis and complications so that they may be reported

immediately to the home IV provider’s

medical personnel.

When appropriate, use of electronic controlling devices (for example, an infusion

pump) in delivery of home IV drug

therapy so that the patient or caregiver

can recognize any malfunction that

should be reported to the home IV

provider.

Emergency interventions for possible IV
190. Home Drug Infusion Therapy Under Medicare

(iv)

(v)

complications that can be performed by

the patient or caregiver.

Discarding IV needles in an appropriate

receptacle (such as a Sharp’s container)

that is properly labeled and that is removed by the home IV provider staff or

personnel at least every 3 days.

Procedures for recording the administration of IV solutions and drugs so the

information can be given to the home IV

provider and attached to the patient’s

clinical record.

(3) The nurse must discuss the range of physical

activity that is appropriate for the patient.

Condition of Participation: Protocols and Policies

The home IV provider adheres to the following

procedures and has written protocols and policies consistent with respect to the provision of home IV drug therapy

items and services.

(a) Standard: First dose. The first dose of any drug

not previously administered intravenously is administered under the direct supervision of a

physician or nurse who must:

(1) remain in attendance for a time period sufficient to make sure that the patient is stable; and

(2) Have resuscitation medication and equipment

to treat anaphylaxis readily available.

(b) Standard: Venipuncture and catheter care.

(1)

(2)

(3)

(4)

(5)

(6)

The site of a peripheral catheter is rotated by

the nurse at least every 3 days. A catheter

whose tip lies in a central vessel must be

rotated by a physician when appropriate.

IV administration sets are changed at least

every 24 hours by the patient or caregiver.

IV dressings should be changed at least every

48 hours or immediately upon becoming

soiled or wet.

The air elimination filter is routinely changed.

The central line catheter site is inspected by a

nurse at least once each week

Aseptic techniques are practiced during all

venipuncture, dressing changes, catheter care,

and assembly of IV infusion systems.

(c) Standard: Quality of the air elimination filter

and sterility of the catheter.

(1) On a sample of patients, the nurse packages air

(2)

elimination filters that have been removed by

the nurse from the IV tubing and immediately

sends then to an independent laboratory for

analysis of particulate matter and bacterial and

fungal contamination.

On a sample basis, the home IV provider

packages catheters that have been removed

(3)

from patients and immediately sends them to

an independent laboratory for analysis of

sterility.

The home IV provider keeps copies of laboratory results on the testing of both air elimination filters and catheters that are made available for review upon request.

(d) Standard: Drug therapy review.

(1) The pharmacist and nurse must review the

combination of IV drugs and equipment for

appropriateness before drug therapy is initiated.

(2) The pharmacist must conduct ongoing review

(at least once every 3 days) of the drug therapy

and inform the physician of significant findings. As a minimum, this review must include

the appropriateness of the drug regimen and

any instances of therapeutic duplication of

drugs.

(e) Standard: Patient rights and responsibilities.

The home IV provider must ensure that the

following requirements are met:

(1)

(2)

(3)

(4)

(5)

Treatment of a patient begins only if the home

IV provider is capable of furnishing needed

care at the level of intensity required by the

condition of the patient.

Each patient receives care appropriate to his or

her needs in a timely manner.

The patient is informed in a timely manner of

the need for transfer to another medical entity

or level of care and of any appropriate

alternatives.

If the home IV drug therapy is to end without

transfer to another medical entity, the patient

is informed in a timely manner of the impending discharge, continuing care requirements

and other available services, if needed.

Patients’ rights as set forth in this paragraph

(6)

are honored and patients are informed of their

responsibilities, if any, in the care process. The

rights and responsibilities are clearly stated in

documents distributed to patients upon admission to the home IV drug therapy program.

Procedures are established to deal with patient

grievances and patient-recommended changes

without coercion, discrimination, reprisal, or

interruption of services. A patient is informed

at the beginning of home IV drug therapy

about these procedures for making, reviewing,

and resolving complaints.

(f) Standard: Written protocols and policies. The

home IV provider has written protocols and

policies that are consistent with these procedures.
Appendix C—Home Intravenous Drug Therapy:ProposedRegulatjons Under the Medicare Catastrophic Coverage Act . 191

Condition of Participation: Quality Assurance

The home IV provider maintains an ongoing quality

assurance program designed to monitor patient care

objectively and systematically, evaluate the quality and

appropriateness of patient care, resolve identified problems, and pursue other opportunities to improve patient

care, resolve identified problems, and pursue other

opportunities to improve patient care.

(a) Standard: Program objectives. Through an ongoing, planned, and systematic process, the home

IV provider monitors and evaluates the quality and

appropriateness of patient care, including the

performance of employees and other personnel

who furnish services under arrangements with the

home IV provider. The home IV provider includes

at least the following in a written evaluation plan:

(1)

(2)

(3)

(4)

(5)

Scope and objectives of the quality assurance

activities.

Activities identified for monitoring and evaluation.

Methods for implementing the monitoring and

evaluation activities and for reporting the

results.

Mechanisms for taking follow-up action.

Staff responsibilities for each activity in the

quality assurance program.

(b) Standard: Patient care.

(1)

(2)

The monitoring and evaluation of the quality

and appropriateness of patient care by the

home IV provider must include identification

of important aspects of care or service and

focus on high-risk high-volume, or problemprone activities.

The home IV provider collects data about the

following matters:

(i)

(ii)

(iii)

Length of home IV drug therapy by

diagnosis and treatment.

Incidence and causes of patient rehospitalization.

Incidence of:

(A) Phlebitis;

(c)

(3)

(B) Infiltration;

(C) Site infection; and

(D) Other infection.

(iv) Hydration and nutritional status.

The home IV provider analyzes the data it

collects at least annually to determine the

frequency of negative outcomes and prescribes corrective action for negative outcomes.

Standard: Service delivery. The provider determines the following:

(1)

(2)

(3)

(4)

(5)

(6)

Drugs and IV equipment were delivered timely

to the patient.

The patient could read the preparation and

expiration dates on the drug labels.

A nurse visited a patient with a peripheral IV

catheter placement every 3 days and rotated

the peripheral IV injection site.

A nurse visited any patient with a central line

at appropriate intervals for monitoring.

Procedures have been established to enable

patients to make complaints.

The provider found acceptable solutions for

complaints and kept a record of both.

Condition of Participation: Infection Control

The home IV provider must develop infection control

procedures. These procedures must address at least staff

personal hygiene and health status, isolation precautions,

aseptic procedures, cleaning and sterilization of equipment, and methods to avoid transmitting infections. The

home IV provider:

(a)

(b)

Advises staff, patients, and caregivers of any

necessary precautions, including infection control

and personal hygiene and their responsibilities in

the infection control program; and

Develops a system for evaluating, reporting, and

maintaining records of infection related to the care

of service provided among patients and as appropriate, among staff.
Appendix D

A BASIC ECONOMIC MODEL

OF HOME DRUG INFUSION PROVIDER BEHAVIOR1

Basic economic models of health provider behavior

have been applied to hospitals, physicians, nursing

homes, and home health agencies. The models are of two

types: 1) those that assume that providers are profit

maximizing, and 2) models of behavior of not-for profit

organizations.

The first type of model has been applied to both

for-profit and not-for-profit organizations, where it is

assumed that not-for-profit providers face essentially the

same financial incentives as for-profit providers operating

in the same markets. Models of the second type (see, e.g.,

references 89,175,244,258) incorporate some specific

factors thought to affect behavior of not-for-profit organizations. These include the possible desire of managers to

maximize size or prestige of their organization or to

satisfy the desires of special interest groups. These

objectives, in turn, may imply that not-for-profit organizations pay more attention to volume of services, quality,

or their reputation for community service than for-profit

organizations.

The critical issue here, however, is whether there are

differences in the way for-profit and not-for-profit organizations respond to incentives created by alternative

payment methods. This appendix will later discuss some

possible differences, but it assumes thereto be substantial

similarities in the responses of for-profit and not-forprofit organizations; similar interests in the financial

viability of the organization transcend differences in form

of control. For both types of organizations the principal

determinants of the quantity, cost, and quality of services

include:

the cost of inputs,

the technology of production,

the demand for services by patients, and

the level and form of public and private payment for

services.

Assumptions

A model must be based on some assumptions about

provider behavior and the cost structure. This model

begins with an assumption that providers are profit

maximizers, or behave much like profit maximizers

subject to some constraints to be specified. It later notes

differences where they may be important.

The model presumes that providers incur some fixed

costs (e.g. administrative overhead) and have a constant

or near-constant marginal cost for services (for equipment, supplies, and labor). These assumptions are reasonable for home drug infusion therapy providers since most

such providers can hire staff locally without significantly

driving up the market price. Most such providers probably

employ a small share of the suitable employees locally

and represent a small share of the national market for

supplies. Limited short-run supply of staff in small market

areas may, nonetheless, lead to an upward-sloping

marginal cost curve for some providers.

The model presumes that providers serve both Medicare and nonMedicare patients. It also presumes that,

except in cases of patient cost sharing (deductibles and

copayments), the demand of Medicare patients is independent of prices charged, but that at least some other

patients (self payers or those with insurance involving

cost sharing) are sensitive to prices. So the demand of

Medicare patients is perfectly price inelastic and providers face a downward sloping demand curve for services

provided to other patients.

Provider Behavior Under Different

Forms of Reimbursement

Figure D-1 illustrates profit maximization under cost

reimbursement. The demand of private-pay patients is Dp

and the associated marginal revenue curve is MRp. The

provider’s average cost curve is AC. This cost curve

should be viewed as endogenous-costs could be higher

or lower, depending on visit quality and provider efficiency. Pp and Pm represent payment levels from private

patients and Medicare, respectively.

In this mode12the provider maximizes profits by setting

marginal revenue equal to marginal cost, where the

marginal revenue curve is detemined by the (horizontal)

sum of the private patient marginal revenue curve and the

demand of Medicare beneficiaries (MRp + Din). At point

A in figure D-1 the provider supplies Q1 units of service

to private-pay patients and Q2-Q1 units to Medicare

1 This appendix is based on T. Oranne_ ‘‘Incentives and Behavioral Response to Alternative Payment Methods for Home Intravenous and

Immunosuppressive Drug Therapies Under the Medicare Program,’ paper prepared under contract to the OffIce of ‘lkchnology Assessment, Washington

DC, February 1990.

2 See reference 111 for basic models of provider behavior, or reference 254 for a similar model of provider response to limited Medicaid payment

rates.

-192-
Appendix D-A Basic Economic Mode/of Home Drug Infusion Provider Behavior . 193

Figure D-l—Home Drug Infusion Therapy Provider

Behavior: Profit Maximization Under

Cost Reimbursement

cost M RP + Dm

\

Profit

\ P

P m ,

\

\

\

\

\

AC

MC

Q, MRP D Qp 2

Quantity of visits

NOTE: See text for explanation.

SOURCE: T. Grannemann, “Incentives and Behavioral Responses to

Alternative Payment Methods for Home Intravenous and immunosuppressive Drug Therapies Under the Medicare Program,” paper prepared under contract to the Offioe of Technology Assessment, Washington, DC, February 1990.

patients. The profit (or surplus for not-for-profit providers) is shown in the shaded area.

Prospective payment, that is, where providers receive

a predetermined, fixed rate of payment, provides strong

incentives to control costs. In figure D-2, under cost

reimbursement the only gain to the provider from

reducing average cost from AC1 to AC2 is the dark area.

But under prospective payment, the provider could keep

the dotted area as profits as well, thus providing extra

incentive to reduce costs. A shift from cost reimbursement

to prospective payment in such circumstances could give

providers a short-run windfall gain in profit or surplus and

could provide Medicare with an opportunity to lower per

unit payments below the initial level of Pm. Profitseeking providers might be the most responsive to such

incentives, while not-for-profit organizations may be less

interested in additional surplus than in maintaining high

quality at the higher cost. The choices for not-for-profit

organizations nonetheless are expanded by prospective

payment, as they are given an opportunity to use any

savings derived from reduced costs for other purposes,

such as covering care for the poor or providing other

services needed in the community.

Figure D-2—Home Drug Infusion Therapy Provider

Behavior: Profit Maximization Under

Prospective Payment

Pp

P m

MC

l\\

\! \

\

\

\

\

\

\

\ \

Q, MRP D Qp 2

NOTE: See text for explanation.

SOURCE: T. Grannemann, “Incentives and Behavioral Responses to

Alternative Payment Methods for Home Intravenous and lmmunosuppressive Drug Therapies Under the Medicare Program,” paper prepared under oontract to the Offioe of Technology Assessment, Washington, DC, February 1990.

Impacts on Quality of Care

Like quantity, the level of quality a provider chooses to

produce can be viewed as a product of supply and

demand. Fully insured patients who have no cost-sharing

requirements can be expected to demand the highest level

of quality, to the point where extra quality provides no

additional benefit (after accounting for any cost in terms

of patient inconvenience). Cost-reimbursed providers

have every reason to be accommodating to these patient

desires. Providers may, however, provide a uniform

standard of care to all their patients. So a provider’s

quality standards may reflect the best possible accommodation to all patients, insured and uninsured.

The provider’s choice of quantity and quality of visits

is illustrated in figure D-3. This figure shows possible

combinations of quality and quantity. The iso-cost (IC)

curves represent combinations of quality and quantity that

can be attained at a given cost. The Engle curve (E)

represents the patient’s preferred combinations of quality

and quantity, given the relative costs of producing each.

This curve is determined by the point of tangency of

indifference curves with iso-cost curves.
194. Home Drug Infusion Therapy Under Medicare

Qua

Figure D-3—Provider Tradeoffs Between Quality and

Quantity of Visits Under Alternative

Payment Methods

lit y

‘o

%

Pric e

D.

Q* Qo Quantit y

I

I

I

I

D

\ !

I

I

I

Q Qo Quantit y

NOTE: See text for explanation.

SOURCE: T. Grannemann, “Incentives and Behavioral Responses to

Alternative Payment Methods for Home Intravenous and lmmunosuppressive Drug Therapies Under the Medicare Program,” paper prepared under contract to the Office of Technology Assessment, Washington, DC, February 1990.

Point A represents cost reimbursement in which the

patient demands and receives Qo visits-the amount

demanded at zero out-of-pocket cost, shown in the lower

portion of the figure. The quality of visits, determined by

the provider’s standard of care, S, is directly related to the

cost curve discussed above. Lower costs imply lower

quality, though more efficient providers may have lower

costs without sacrificing quality.

Point B in figure D-3 represents the likely result of

per-visit prospective payment that covers at least marginal

cost. The provider has incentives to keep costs lower than

with cost reimbursement and may provide services of

somewhat lower quality. But the provider has no reason

to deviate from the patient’s desired quantity of care,

Qo-since the provider continues to make a profit on each

unit of service.

Point C represents the possible outcome of per-month

or per-episode prospective payment. Providers would

maximize profits by keeping costs as low as possible

subject to the need to maintain patient satisfaction

sufficient to maintain a suitable patient load. Professional

standards, or quality assurance standards imposed by

Medicare, must also be met. Profits can be expressed as:

Profit = N(quality, quantity) * payment - cost(quality,

quantity)

First order conditions for profit maximization require

that the marginal contribution of quality and quantity to

number of patients (N) weighted by the payment rate just

equals their respective marginal contribution to cost.

To maximize profits, then, providers must operate

where the marginal cost due to increased quality (quantity) just equals the marginal benefit in terms of patients

added due to a quality (quantity) increase. Providers thus

must be responsive to patient preferences regarding

quality and quantity mix. It is likely, therefore, that

providers under per-month or per-episode prospective

payment will operate close to the Engle curve in figure

D-3 and on an iso-cost curve lower than would be the case

under cost reimbursement or per-visit prospective payment. If, as shown by point C and the lower portion of

figure D-3, competitive forces lead to a point on the Engle

curve where the quantity equals what would be demanded

by an uninsured patient, then an optimal quantity and

quality would also be achieved in the sense that marginal

cost equals marginal benefit to the patient. One would

therefore expect per-month or per-episode prospective

payment to lead to lower quality and fewer visits per week

than would be found under cost reimbursement.

While incentives would lead providers in this direction,

competitive forces and quality assurance regulations

could counterbalance this effect. If policymakers desire

higher quality and frequency of visits than competitive

forces and professional standards can sustain, then

regulations or other quality assurance systems must be

established.

To summarize the implications of this model:

●

●

●

Cost reimbursement promotes high quality care with

incentives for providers to meet any patient demands

for quantity (frequency) of service.

Per-visit prospective rates promote cost control and

lower quality, without any incentive to reduce

quantity (frequency) of visits.

Per-month or per-episode prospective payments

encourage both cost control and reduction in quantity or frequency of visits.
Appendix D—A Basic Economic Model of Home Drug Infusion Provider Behavior . 195

. Quality assurance mechanisms or regulatory con- quality but not frequency of visits. Under per-month

trols may be used to counter some of the adverse or per-episode rates, controls maybe needed on both

effects of incentives under prospective payment. quality and frequency of visits.

Under per-visit rates, controls may be needed on
Appendix E

GLOSSARY OF TERMS

Access: Potential and actual entry of a population into the

health care delivery system.

Acute care: Services within a hospital setting intended to

maintain patients for medical and surgical episodic

care over a relatively short period of time.

Acute disorder: Characterized by a sudden onset,

marked symptoms, and a short course.

Analgesic drug: A substance causing loss of sensitivity

to pain without loss of consciousness.

Anaphylaxis: An unusual or exaggerated allergic reaction to foreign proteins or other substances.

Anemia: An abnormal decrease in the concentration of

erythrocytes (red blood cells), concentration of hemoglobin, or hematocrit.

Antibiotic drug: Any of a number of substances produced by one microorganism and inhibitory to another

microorganism.

Antineoplastic drug: Substance acting against the formation of a tumor.

Artery: A blood vessel that carries the blood away from

the heart to the various parts of the body.

Aseptic: Free from infection.

Average cost: For a home infusion provider, average

total cost per patient is the sum of all the provider’s

costs of providing services, divided by the number of

patients served. Of total costs, some costs are fixed in

the short run (e.g., capital equipment), while others

vary depending on the number of patients served (e.g.,

dressing supplies). Average variable costs are the sum

of these variable costs, divided by the number of

patients served. In the long run, average variable costs

may approximate marginal costs.

Catheter: In infusion therapy, the tube that is inserted

into the body (e.g., into a vein) so that drugs or other

fluids can be administered.

Cellulitis: Infection of the skin and surrounding soft

tissue.

Central access device: An infusion device in which the

catheter is inserted directly into a large vein near the

heart.

Chronic disorder: A disorder characterized by extended

duration and typically by slow development or a

pattern of recurrence.

Conditions of participation: Requirements that a hospital or other health care facility must meet in order to be

allowed to receive payments for Medicare patients. An

example is the requirement that hospitals conduct

utilization review.

Cystic fibrosis: A genetic disorder that results in

abnormal mucous secretions, including excess mucus

in the lungs. Persons with cystic fibrosis are predisposed to recurrent pulmonary infections.

Cytotoxic drug: A drug that has a specific toxic action

upon cells or special organs.

Diagnosis-related groups (DRGs): Groupings of diagnostic categories drawn from the International Classification of Diseases and modified by the presence of a

surgical procedure, patient age, presence or absence of

significant comorbidities or complications, and other

relevant criteria. DRGs are the case-mix measure

mandated for Medicare’s prospective hospital payment system by the Social Security Amendments of

1983 (Public Law 98-21).

Dialysis: In persons with end-stage renal disease, a

process that rids the body of liquid waste products,

replacing the kidney’s normal function.

Drug regimen: A systematic plan for taking medication

that is designed to improve or maintain the health of a

patient.

Durable medical equipment: Medical equipment that is

capable of withstanding repeated use, generally not

useful to someone in the absence of injury or illness,

and appropriate for home use. Examples include

intravenous poles and infusion pumps.

Elastomeric infuser: An infusion device that consists of

a disposable container with an inner elastic bladder that

can be filled with medication.

Embolus: A detached blood clot, air bubble, or clump of

foreign matter that blocks or occludes a blood vessel.

Enteral nutrition: The intake of nutrients that undergo at

least partial processing in the intestine. Strictly speaking, enteral nutrition includes normal food intake

through the mouth. However, the term is often used to

indicate more specifically the intake of nutrients

through a tube that leads directly to the stomach or the

small intestine.

Epidural drug administration: Entrance of a drug into

epidural space surrounding the spinal cord, so that the

drug is absorbed directly into the spinal cord.

Extravasation: The forcing out of fluid (e.g., an infused

drug) from a proper vessel into the surrounding tissue.

Family caregiver: A family member or friend who

assists the patient in self-care responsibilities on an

unpaid basis.

Febrile: Of or pertaining to fever.

Fiscal intermediary: An organization that acts as an

agent and purchaser of health care insurance or health

care services for an insurer. Medicare’s fiscal intermediaries include Part A intermediaries and Part B

carriers (see Medicare intermediaries or carriers).

Granulocyte: A leukocyte (white blood cell) that contains granules in its cytoplasm.

Gravity drip system: A drug delivery system in which a

bag or bottle is hung on a hook or a pole above the level

-196-
Appendix E-Glossary of Terms . 197

of the patient, and fluid flows by gravity down the line

and into the catheter. The rate of flow in a simple

gravity drip system is controlled primarily by a special

clamp or valve on the line that can be adjusted to

permit the prescribed amount of fluid to flow through.

Health maintenance organization: A health care organization that, in return for prospective per capita

payments, acts as both insurer and provider of comprehensive but specified medical services.

Hemolytic reaction: A process by which erythrocytes

(red blood cells) are destroyed.

Hemophilia: An inherited disease in which the body

lacks blood coagulation (clotting) factors.

Heparin: An anticoagulant drug.

Homebound: Confined to the home.

Home drug infusion therapy: Treatment that consists of

prolonged (or continuous) injections of drugs that are

administered in the home, usually repeatedly.

Home health agency: An organization that delivers

health services to patients in the home setting.

Hospice: A facility or program designed to provide a

caring environment for supplying the physical and

emotional needs of the terminally ill.

Immune globulin: A biological preparation that consists

of proteins from human blood plasma. These proteins

react with foreign proteins to form antibodies that aid

in the body’s defense against infections.

Immune system: The body’s defense method, characterized by a high degree of resistance to specific foreign

substances.

Infiltration: The accumulation in a tissue of substances

not normal to it or in amounts in excess of the normal.

Infusion: In this report, the slow, prolonged injection of

a fluid into the body.

Infusion pump: A device that moves an infused fluid into

the body under positive pressure.

Inpatient services: Care that includes an overnight stay

in a medical facility.

Intravenous drug administration: Entrance of a drug

into the body by way of a vein.

Length of stay (LOS): The number of days a patient

remains in the hospital from admission to discharge.

Licensed practical nurse: A nurse with usually 12

months of practical nursing training and licensure, as

opposed to a registered nurse with a four year

baccalaureate degree and licensure.

Marginal cost: The incremental cost to the provider or

supplier of serving one more patient.

Medicaid: A Federal-State medical assistance program

authorized in 1965 to pay for health care services used

by people who meet income and other requirements.

Eligibility requirements and benefits vary from State

to State.

Medicare: A nationwide, federally administered health

insurance program authorized in 1965 to cover the cost

of services for eligible persons over age 65, persons

receiving Social Security Disability Insurance payments for 2 years, and persons with end-stage renal

disease. Medicare consists of two separate but coordinated programs-hospital insurance (Part A) and

supplementary medical insurance (Part B). Health

insurance protection is available to insured person

without regard to income.

Medicare beneficiary: One who receives coverage for

health services under Medicare.

Medicare intermediaries or carriers: Fiscal agents

(typically Blue Cross plans or commercial insurance

firms) under contract to the Health Care Financing

Administration for administration of specific Medicare

tasks. These tasks include determining reasonable

costs for covered items and services, making payments, and guarding against unnecessary use of

covered services. In this report, intermediaries and

carriers are collectively referred to as fiscal intermediaries.

Metabolism: The totality of chemical processes occurring in a living organism.

Narcotic: A drug that dulls the senses, relieves pain, and

induces profound sleep.

Neoplastic disease: A condition causing or resulting in

tumor formation.

Nosocomial infection: An infection originating in a

hospital.

Osteomyelitis: Infection of the bone.

Outpatient facility: A healthcare facility where medical

services are provided to patients who are not inpatients

of hospitals.

Palliative treatment: Treatment whose goal is patient

comfort rather than cure.

Parenteral drug administration: Entrance of a drug into

the body by means other than through the digestive

tract.

Peer Review Organization: Organizations established in

1982 (Public Law 97-248) with which the U.S.

Department of Health and Human Services contracts to

review the appropriateness of settings of care and the

quality of care provided to Medicare beneficiaries.

Per capita payment: A payment rendered to a provider,

typically on a monthly basis, to cover costs of all care

provided to that patient during a given time period.

Primary care physician: A physician who provides

basic first-line medical care, such as a practitioner,

general pediatrician, obstetrician/gynecologist, and

general internist.

Prospective payment: Payment for medical care on the

basis of rates set in advance of the time period in which

they apply. The unit of payment may vary from

individual medical services to broader categories, such

as hospital case, episode of illness, or person (cavitation).

Prosthetic device: An artificial replacement for a missing

(or nonfunctional) body part.
198. Home Drug Infusion Therapy Under Medicare

Pulmonary embolism: The sudden obstruction of a

blood vessel in the lungs by an abnormal particle

circulating in the blood.

Quality assessment: Measurement and evaluation of the

quality of health care provided to individuals or to

groups of patients.

Quality assurance: Conduct of activities that safeguard

or improve the quality of health care by correcting

deficiencies found through quality assessment.

Retrospective payment: A payment method for health

care services in which hospitals (or other providers) are

paid for services rendered after the service has taken

place. In this country, the term has traditionally

referred to hospital payment, since other providers

have generally been paid on the basis of charges

instead of costs.

Secondary infection: A second infection occurring in a

person already suffering from an infection of another

nature. For example, a person being treated by drug

infusion for a bone infection could become secondarily

infected as a result of organisms entering the body

through a catheter.

Septicemia: The presence of disease-causing bacteria in

the bloodstream.

Skilled nursing facility: A subacute or long-term care

facility that provides skilled nursing care (i.e., care that

requires the expertise of a trained nurse).

Subcutaneous drug administration: Entrance of a drug

into the body by means of a needle or catheter inserted

under the skin.

Swing-bed: Licensed acute-care beds designated by a

hospital to provide either acute or long-term care

services. A hospital qualifying to receive Medicare and

Medicaid reimbursement for care provided to swingbed patients must be located in a rural area (as defined

by the U.S. Bureau of the Census), have less than 100

acute-care beds, and (when applicable) must have

received a certificate of need for the provision of

long-term care services from its State health planning

and development agency.

Third-party payer: Payment by a private insurer or

government program to a medical provider for care

given to a patient.

Thrombocytopenia: A condition that results in a fewer

than normal number of platelets per unit volume of

blood.

Thromboembolic disease: Obstruction of a blood vessel

with thrombotic material carried by the bloodstream

from the site of origin to plug another vessel.

Thrombophlebitis: Inflammation of a vein associated

with thrombus formation.

Thrombus: An aggregation of blood factors, primarily

platelets; a clot. If the clot detaches and moves

elsewhere in the bloodstream, it is termed an embolus.

Total parenteral nutrition: A feeding system that

includes all the nutrients needed by the body and that

is introduced into the body intravenously.

Vascular system: The body’s network of arteries, veins,

and capillaries.

Vein: A vessel that carries blood from various organs or

parts back to the heart.

Vesicant: A substance capable of inducing discharge or

blister.
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