Reimbursement of Biotherapy: Present Status, Future Directions -Perspectives of the Office-Based Oncology Nurse Deanna Xistris Economic forces are stimulating cost sensitivity and the need for clinical efficiency in medicine. The federal government has led the way with Medicare reform, and costcontainment efforts are evident in all health care payer programs. More and more, the office-based oncology nurse is involved in reimbursement issues as both a colleague and a patient advocate. Creative solutions to the challenges of reimbursement require knowledge of the issues, familiarity with patient-specific therapies, and recognition of unique cost and billing issues. Biologic agents frequently used in office-based oncology practice are easy targets for reimbursement denials because of regulations against their investigational status, “off-label” use, method of administration, and relatively high cost. Such agents include interferon, erythropoietin (EPO), granulocyte and granukxzyte-macrophage colonystimulating factors (G-CSF and GM-CSF, respectively), and interleukin-2 (IL-2). Reimbursement decisions are often characterized by inconsistency and uncertainty, and rulings are based not only on law, but also on interpretation. The need for clarification often opens a window for negotiation for the complex reimbursement issues associated with biotherapy. In addition to thoroughly determining cost and accurately assigning appropriate Current Procedural Terminology (CPT) codes, office-based oncology nurses can pursue various strategies to help their patients and practices obtain reimbursement of biotherapy. Chief among these is educating third-party payers on the appropriateness and necessity of newer treatment modalities. In individual cases, documentation of the scientific data, clinical outcomes, and cost benefits supporting a treatment decision almost always gains reimbursement. Office-based oncology nurses can also participate with professional societies to set standards of care that differentiate between state-of-the-art and experimental therapy. Copyright 0 1992 by W. B. Saunders Company.

CONOMIC FORCES are stimulating cost sensitivity and increasing the need for clinical efficiency throughout the health care system. The federal government has led the way with Medicare reform, and cost-containment efforts are evident in all health care payer programs, eg, diagnostic-related groups (DRGs) and managed care.

E

From the P.C. Bennett Cancer Center, Stamford, CT. Address reprint requests to Deanna Xistris, RN, MSN, Clinical Specialist, Oncology Hematology Oncology, PC, 34 Shelburne Rd, Stamford, CT 06902. Copyright 0 1992 by W.B. Saunders Company. 0749-2081/92/0804-1007$05.00/O

8

seminem

Although budgets and cost containment are not new to nurse administrators and hospital managers, helping obtain reimbursement generally has not been perceived as a nursing role. However, in present day nursing practice, financial awareness has filtered down to permeate all staff levels and settings. Responsibility for billing and reimbursement has been cited as part of the job description for office-based oncology nurses.’ For the officebased practitioner, the perspective on reimbursement is one of urgency and daily challenge. Office-based oncology nurses must help ease the distress of patients who face choices of state-ofthe-art therapy and its financial consequences. At the same time, they must resolve the professional dilemma of securing reimbursement for nursing services through a system defined primarily for physician-rendered care (Medicare “B”). Creative solutions to these challenges require knowledge of reimbursement issues, familiarity with patient-specific therapies, and recognition of cost and billing issues unique to oncology practice, particularly in the office-based setting. REIMBURSEMENT ISSUES SPECIFIC TO BIOTHERAPY

Biotherapy, like many aspects of cancer care, does not fit neatly into categories designed for reimbursement. Although state-of-the-art oncology care may mandate biotherapy, biologic agents frequently used in the office setting are easy targets for reimbursement denials because of regulations against their investigational status, “offlabel” use, method of administration, and relatively high cost. Investigational

Status

Investigational status applies to any medication not yet approved by the Food and Drug Administration (FDA). Of-Label

Use

Off-label use is defined as the use of a drug(s) for a specific disease that is not listed in the package insert as an indication for therapeutic usage in Oncology

Nursing,

Vol8,

No 4, Suppl

1 (November),

1992:

pp 8-l 2

PERSPECTIVES

OF THE OFFICE

or, alternatively,

ONCOLOGY

NURSE

not listed in all three compendia

PATIENT-SPECIFIC

THERAPIES

(Drug Evaluations by the American Medical Association; American Hospital Formulary Service Drug Information 1992; or The United States Pharmacopeia Dispensing Information) as an ac-

Biotherapeutic agents commonly used in office-based oncology practices are listed below.

ceptable indication.

The FDA approved interferon alfa for the treatment of hairy cell leukemia in 1986 and acquired immunodeficiency syndrome (AIDS)-related Kaposi’s sarcoma in 1989. For patients with these diseases, the reimbursement difficulty is simply: no Medicare reimbursement for self-administered medications. To avoid considerable out-of-pocket expense, individuals with Medicare coverage must have interferon administered in the physician’s office. However, private insurers generally defray costs of self-administered drugs, particularly when the policy includes prescription coverage. Interferon alfa and/or beta are also effective against other neoplasms,2 among them hematologic malignancies such as chronic myelogenous leukemia, mycosis fungoides, multiple myeloma, and low-grade non-Hodgkin’s lymphoma, and solid tumors such as renal cell carcinoma, malignant melanoma, and superficial bladder cancer. For this patient population, the reimbursement problem is compounded by the issue of off-label use.

Method of Administration Biotherapy agents (hematopoietic growth factors, colony-stimulating factors [CSFs], interferon) are typically self-administered. Self-administered medications are definitely not reimbursed by Medicare. However, private-payer programs that cover prescription drugs do reimburse for self-administered CSFs and interferon.

Relatively High Cost Biotherapy agents are high-technology, highcost items. The approximate cost for a lo-day treatment cycle of CSFs is $1,350, when self-administered, and $1,396, when administered in the office and the allowable $4.64 Medicare administration charge for a daily therapeutic injection is added. A l-month supply of interferon at the modest total dose of 10,000 U administered three times a week averages $1,080. In cost-effective analysis, interferon is compared with other primary treatment modalities. However, CSFs are used as supportive therapy, aimed at preventing and mitigating life-threatening side effects of chemotherapy. Should such costly agents be reimbursed when they are given to prevent sepsis and hospitalization that may, but is not certain to, occur? For a given individual, the answer is always, “Yes, this is my life!” However, the rising cost of such treatment is one of the many factors that has caused the govemment and private insurers to rethink the regulation and financing of medical care. Decisions on reimbursement of biotherapy are often characterized by inconsistency and uncertainty. State Medicare rulings, however well intentioned, are based not only on federal law, but on interpretation. Medicare and private-payer programs base reimbursement on guidelines and policy, which then must be applied to a specific client/patient. The need for clarification often opens a window for negotiation for the complex reimbursement issues associated with biotherapy.

Interferon

EPO This agent is potentially useful in the treatment of significant anemia(s) due to chemotherapy, cancer, and AIDS. However, the chronic nature of therapy and the need to modify dosage to achieve and maintain response bring about frequent challenges to and denials of reimbursement. Medicare generally reimburses for EPO once it has been shown effective for a given patient and when it is administered in the physician’s office. Private insurers also defray EPO when it is self-administered, as it can be by subcutaneous injection,

CSFs Granulocyteand granulocyte-macrophage CSFs (G-CSF and GM-CSF, respectively) have clinical use as a critical supportive therapy for patients receiving aggressive and potentially curative chemotherapy. Initially approved for use in bone marrow transplantation programs, the “growth factors” quickly found their way into

DEANNA

10

routine practice because of their ability to reduce the degree and duration of neutropenia and the number of episodes of fever and hospitalizations for treatment of infections. The high cost, subcutaneous route of administration, and magnitude of usage of these agents have brought CSF therapy to the forefront of the reimbursement dilemma. Third-party payer, clinician, and patient have been confronted with the very high financial cost of a therapy to prevent a potentially fatal infection that may result from chemotherapy. Initially, Medicare required at least one documented episode of febrile neutropenia before reimbursing for G-CSF. The moral dilemma posed by such a dictum outraged many health care providers. Currently, Medicare often will defray G-CSF when documentation of a patient’s risk of neutropenia is provided. Increasingly, most private payers also are reimbursing for GCSF, when furnished with documentation. Reimbursement for GM-CSF remains more variable because of difficulty in documenting distinctions between its role and that of G-CSF. IL-2

Recently approved by the FDA for the treatment of renal cell cancer, IL-2 is typically administered as an infusion via a venous access device. As such, reimbursement is not likely to be a problem for the office-based practice. However, preliminary experience with IL-2 as an investigational drug highlighted an emerging new role for office-based oncology practice. InTable Expense Physician Nursing

I.

ldentifvina

and

Allocatina

Item

services services

Drug Drug administration Other services

Costs

CPT Code

Dffice

visit

Minimal

(by level)

office

Chemotherapy Administration Special

Categcq

visit of chemotherapy

procedures

Laboratory Bone marrow Phlebotomy Transfusion Specialized equipment (eg, Huber needles for port access) Patient/family education Follow-up

Equipment

? ?

Table

2.

Strategies

for Obtaining

1. Accurately and thoroughly to the most appropriate Determine

cost

requirements 2.

of drugs

of each

Advise, inform, appropriateness In general: directors,

and

In individual cases: clinical outcomes, treatment 3.

costs

medical

and allocate

them

supplies

therapy (time, specral patient care, and other

therapy)

and educate and necessity

contact medical

Reimbursement

identify CPT code.

Determine costs of administering skills, services and equipment,

XISTRIS

third-party of newer

case managers, directors

payers on the modakties. state

Medicare

help document the scientrfic and cost benefits supporung

data, a

decision

Participate with professional societies to set standards care that differentiate between state-of-the-art and experimental therapy.

of

creasingly, office-based oncology practices participate in clinical trials through cooperative study groups (eg, the Eastern and Southwestern Cooperative Oncology Groups [ECOG and SWOG, respectively]) and the National Cancer Institute Class C drug program. The classification of a patient as “on study” does not automatically pose a reimbursement problem. Experimental drugs are often provided free of charge. However, a therapy such as IL-2, with its many side effects and intense patient care requirements, raises reimbursement difficulties related to specialized staff and room utilization. Furthermore, off-label usage often emerges as a key issue for phase III trial participants. RECOGNITION OF COST AND BILLING ISSUES UNIQUE TO ONCOLOGY PRACTICE

In many practices, the clinical nurse is also the “purchasing agent” and “inventory manager” for drugs and medical supplies and thus is aware of current drug and supply costs. In all practices, the nurse has a thorough understanding of the special skills, services, time, and equipment required to administer each therapy, as well as the predictable needs and care requirements of patients receiving it. For example, the intravenous administration of doxorubicin differs from that of 5-fluorouracil in its risk management; the care requirements of a patient who remains in the office for 1 hour may be greater than those of a patient who remains for 8 hours. A patient receiving interferon, with the predictable side effects of fatigue and fever, requires considerably more

PERSPECTIVES

OF THE OFFICE

Table Company

Drug

Compeny-Sponsored

(in alphabetical

Reimbursement

Cetus Oncology Reimbursement

order)

Biotherapy

Services Agent

Telephone

(Neupogen@) l-800-272-9376

(financial

assistance;

indigent

patient

program) Aldesleukin

Corp. Hotline

Hoechst-Roussel Reimbursement

Roche Inc. (reimbursement

Inc. Service

(ProleukiW)

GM-CSF

(Prokineo)

Interferon

alfa-2a

l -800-PROKINE (Roferon@-A)

assistance)

l-800-443-6676

Program Program

l-800-227-7448 l-800-526-6367

lmmunex

GM-CSF

Reimbursement

(IL-2)

l-600-775-7533

Pharmaceuticals Information

Cost-Assistance indigent Patient

(Leukinem)

Hotline

l-800-32

Ortho Biotech (a subsidiary Procritline (reimbursement Cost-Sharing

of Johnson assistance)

8 Johnson)

l-800-553-385

Program Interferon Information

FOR OBTAINING

alfa-2b

(Introno

A) l-800-52

teaching time than an individual receiving CSFs, even though the drug-administration technique to be taught is the same. Meeting the educational needs of patients and their families is a critical and time-consuming aspect of office-based oncology nursing. Patients receiving biotherapy often must learn technical skills for drug administration, and methods of proper drug storage and drug preparation. Learning to identify and manage side effects is also necessary for both patient and family members. A clear role exists for nurses to help their practices accurately and thoroughly determine costs and allocate these costs to the most appropriate Medicare Current Procedural Terminology (CPT) category3 (Table 1). This can best be accomplished through a collaborative effort with the managing partner and the office manager, to which the nurse can make a crucial contribution. STRATEGIES

1

l-800-441-1366 l-800-447-3437

Corp.

Reimbursement

l-4669

EPO (Procrito)

Program

Financial-Assistance Schering-Plough Interactive

Information

Hotline

Net Program

Hoffmann-La Oncoline

3.

11

NURSE

G-CSF

Amgen Inc. Reimbursement Safety

Programs

ONCOLOGY

REIMBURSEMENT

In addition to thoroughly determining cost and accurately assigning appropriate CPT codes, office-based oncology nurses can pursue various strategies to help their patients and practices obtain reimbursement and to overcome specific obstacles regarding biotherapy (Table 2).

l-7

157

The office-based oncology nurse has a key role in the education of third-party payers on the appropriateness and necessity of newer modalities such as biotherapy. This education can be carried out in general, through workshops, and in patient-specific cases, through contact with case managers. An accurate explanation of how or why a therapy is given is often enough to obtain reimbursement when the therapy is so new that it might be unfamiliar to the insurance reviewer. Likewise, physician contact with insurance company medical directors and state Medicare directors is an effective method of persuading insurers to view treatments as state-of-the-art and justified rather than investigational and unproven. Liaison committees have been established in some states between oncologists and state Medicare directors. Through such joint efforts, criteria can be established for Medicare approval for grey areas such as off-label use. In individual cases, documentation of the scientific data, clinical outcomes, and cost benefits supporting a treatment decision almost always gains reimbursement. For example, the cost effectiveness of EPOs can be documented by a letter outlining the improved quality of life, decreased risks, and savings from the reduced need for transfusions and special equipment, staff, and rooms.

12

A variety of drug company-sponsored reimbursement information services are available via toll-free telephone numbers to assist nurses and other health care professionals (Table 3). Documentation is useful in an initial claim, and vital to the appeal that should be made whenever a claim is rejected. Many private oncology practices now include a billing department to assist patients with claims and appeals. Finally, nurses and physicians must work to define standards of practice that differentiate between state-of-the-art and experimental therapy. Professional organizations such as the American Society for Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) can play a key role in defining accepted practice and target populations so that new technologies can be used to meet patient needs in a cost-effective manner.

DEANNA

XISTRIS

Undoubtedly, even “enlightened” standards and guidelines will be open to criticism as restrictive. However, professionals, patient groups, and legislatures each must help resolve these difficult issues. Office-based oncology nurses have a thorough understanding of both therapies and reimbursement. They therefore have the opportunity to influence and improve the reimbursement system as case managers, patient advocates, and politically aware citizens. REFERENCES

1. Barhamand B: A survey of the role, benefits and realities of the office-based oncology nurse. Oncol Nurs Forum 18:3 l31, 1991 2. Gilyon

L: Office management of the interferon patient. Office Oncol Nurs 3: 1-4, 1989 3. Felts W (ed): CPT-Physicians Current Procedural Terminology. Chicago, IL, American Medical Association, 1991

Reimbursement of biotherapy: present status, future directions--perspectives of the office-based oncology nurse.

Economic forces are stimulating cost sensitivity and the need for clinical efficiency in medicine. The federal government has led the way with Medicar...
451KB Sizes 0 Downloads 0 Views