Abstract
Background. Naturopathic oncology in conjunction with conventional treatment is commonly referred to as integrative oncology (IO). Clinics directed by oncology board certified NDs (Fellows of the American Board of Naturopathic Oncology or FABNOs) provide high-quality data for describing IO therapies, their costs and measuring clinical outcomes. Purpose. To describe the types of IO therapies prescribed to breast cancer patients by ND FABNO physicians. Study participants (n = 324). Women who sought care at 1 of 6 naturopathic oncology clinics in Washington State were asked to enroll in a prospective 5 year observational outcomes study. Methods. Medical records were abstracted to collect treatment recommendations and cost data. Results. More than 72 oral or topical, nutritional, botanical, fungal and bacterial-based medicines were prescribed to the cohort during their first year of IO care. Trametes versicolor was prescribed to 63% of the women. Mind-body therapy was recommended to 45% of patients, and 49% received acupuncture. Also, 26% were prescribed injectable therapy, including mistletoe, vitamin B complex (12%), IV ascorbate (12%), IV artesunate (7%), and IV nutrition and hydration (4%). Costs ranged from $1594/year for early-stage breast cancer to $6200/year for stage 4 breast cancer patients. Of the total amount billed for IO care for 1 year for breast cancer patients, 21% was out-of-pocket. Conclusions. IO care for women with breast cancer consists of botanical and mushroom oral therapies, parenteral botanical and nutrient therapy, mind-body medicine and acupuncture. IO clinic visits and acupuncture are partially paid for by medical insurance companies.
Introduction
More and more people diagnosed with cancer are choosing to supplement their conventional oncology treatment with complementary care provided by licensed complementary and alternative medicine (CAM) providers, including doctors of osteopathy, doctors of traditional Chinese medicine (TCM), and oncology board certified naturopathic oncologists (Fellows of the American Board of Naturopathic Oncology or FABNOs; http://www.fabno.org/), some of whom are co-licensed as acupuncturists. This growing field of medicine is increasingly being referred to as integrative oncology (IO). ND, FABNO consultations and some procedures are reimbursed by medical insurance companies in some states in the United States.
Because of their training and their licensed scope of practice, ND, FABNO are among those able to offer comprehensive whole-person integrative cancer care. For this reason, IO clinics directed by ND, FABNOs are a source of high-quality data for describing these therapies and their costs and measuring clinical outcomes. IO clinics are a rich source of data for cost-effectiveness research. Such care consists of a whole-person-oriented approach, including a variety of evidence-based complementary and integrative medicine practices that include a diversity of nutrient and botanical natural products, diet and exercise plans, acupuncture, hyperthermia, and mind-body medicine. Many of these therapies are based on clinical evidence.1-4 Although cost and cost-benefit analyses of CAM and integrated health care have been conducted5,6 and CAM use among breast cancer patients described, 7 neither IO care nor its costs as it is practiced in community settings has been well described. Description of IO medical services is a required step toward evaluating its impact on disease-free and overall survival in breast cancer as well as measuring its cost-effectiveness.
Washington State provides an ideal environment for our study because IO providers are licensed and regulated by the Washington State Department of Health for all licensed complementary and alternative medicine (CAM) providers and many CAM services such as acupuncture. In Washington State, medical insurers are required to reimburse for visits to licensed CAM providers, including NDs as well as lab tests and imaging studies ordered by NDs. The scope of practice for NDs in Washington State is broad, including the oral, topical, and parenteral prescription of natural substances, including nutrients and botanicals.
The Seattle/Puget Sound area in western Washington State was selected for this study because many women with breast cancer seek care at IO clinics led by experienced ND, FABNOs who treat many breast cancer patients each year. To describe the costs of IO care, we selected a high-volume IO clinic in an academic setting located in the Seattle area of Washington State where there is a large population of breast cancer patients who seek integrative care. The methods used to conduct a matched comparison prospective observational study in CAM community clinics have previously been described. 8 The current article provides a description of breast cancer IO treatments recommended and their costs per year.
Methods
Participants (n = 324)
Each breast cancer patient who sought IO care at any of the participating naturopathic clinical sites between February 2, 2009, and April 14, 2014, was invited to participate in an observational outcomes study of quality of life and clinical outcomes associated with such care. For each patient who consented to participate, a signed medical release of records was also obtained in order to access and abstract each woman’s medical records. Of the 378 cases enrolled in this Bastyr and Fred Hutchinson Cancer Research Center collaborative study, we collected 1 year’s worth of treatment recommendations for 324 women. This cohort of participants was used to describe treatments recommended by ND, FABNOs during the first year of care to women with stage 0 to 4 breast cancer. Contained within this cohort was a nested subset of 287 women who had, at minimum, a second clinic visit within 7 months of their first office call (FOC). Breast cancer patients who received treatment at Bastyr Integrative Oncology Research Center (BIORC) and enrolled in the observational study between February 2, 2009, through January 31, 2015, were used to estimate costs for the cost analysis if they had at least 2 IO clinic visits, and we were able to collect at least 1 year’s worth of data (n = 213).
Collection of Data on Stage and Conventional Oncology Treatments Received
Stage of breast cancer at diagnosis was collected for each participant from the Western Washington Cancer Surveillance System, which is part of the national Surveillance Epidemiology and End Results (SEER) database. Stage of breast cancer at the study enrollment date was obtained from conventional medical charts. Conventional oncology medical charts were searched and abstracted for treatment plans and prescriptions.
Abstraction of Data on IO Care
Medical records were requested at the study-defined time points of 6 months and 1 year post-FOC. Trained staff abstracted each chart for types of IO therapy, and dietary and lifestyle recommendations.
Study data were collected and managed by the Bastyr research team for prospective cancer outcomes studies using REDCap (Research Electronic Data Capture) electronic data capture tools hosted at Bastyr University. REDCap is a secure, web-based application designed to support data capture for research studies, providing an intuitive interface for validated data entry, audit trails for tracking data manipulation and export procedures, automated export procedures for seamless data downloads to common statistical packages, and procedures for importing data from external sources. 9
Chart abstractors identified each IO therapy recorded in the treatment plan. The REDCap data entry form provided the abstractor a checklist of 79 commonly recommended oral and topical CAM therapies, 14 types of injectable therapies, 33 types of dietary recommendations, 10 mind-body medicine therapies, and 8 lifestyle recommendations. This list was generated by the consensus of the lead physicians of the IO clinics. Any therapies not on the checklist were entered into the “other” category and written in as free text. Data gathered included the type and date of physician recommendation. Standard doses and frequencies of doses for each therapy were gathered using a separate physician survey conducted concurrently.
Categorization of IO Treatments
To streamline statistical analyses, some IO treatments that were recommended during conventional standard oncology treatment (eg, surgery, chemotherapy, radiation and hormone, biological and immune therapies) were categorized into 1 of 2 categories. Treatment recommended concurrently with standard oncology treatments were designated as those recommended to the patient while in treatment. Treatment recommendations made to any patient during the year following diagnosis were also designated as being recommended in treatment. Treatment recommendations made during the year following standard therapy were categorized as those being made during survivorship. Results describe therapies recommended during the first year of IO care for each stage of breast cancer.
Data on IO Physician Consultation and IO Procedures
Electronic health records at the IO clinic that contributed the most participants (BIORC) were used to collect data on number and type of clinic visits using Current Procedural Terminology (CPT) codes. Consultations were defined as office visits, with procedure codes indicating interaction with an IO physician.
Cost Data
Costs of outpatient medical care typically fall into 5 categories: office visit consultation (evaluation and management [E&M] CPT codes), procedures, laboratory tests, imaging, and pharmacy. Because most ND, FABNOs use lab and imaging data provided by requesting each patient’s medical oncology records, the largest proportion of IO care falls into 3 categories: office visits (E&M CPT codes), procedures, and natural medicine pharmacy.
Four data sources were used to collect cost data:
BIORC electronic billing records were used to collect data on number and cost of visits and procedures using CPT codes for consultation, E&M office visits, and procedures for each patient.
BIORC fee schedules were used for pharmacy items.
Price data were gathered from commonly used internet websites for typical prices for other natural medicines prescribed to breast cancer patients enrolled in the study (such as the site maintained by Emerson Ecologics, LLC).
The costs of procedure recommendations that are not medical procedures, such as “take a yoga, meditation, tai qi, or qi gong class,” were obtained from a survey of local classes advertised in the Seattle area.
Cost data from these 4 data sources was entered into a relational database for analysis. Visit, procedure, and pharmacy costs were stratified by stage of the patient at the first office visit and whether the treatment recommendations were made during each woman’s primary standard oncology treatment period or during survivorship after completion of initial treatment. Additionally, the percentage of cost covered by insurance and the percentage paid by the patient was also included in the analysis.
Results
Table 1 shows the race, ethnicity, and age for the entire cohort of breast cancer patients who utilized IO care and enrolled in the outcomes study (n = 324).
Demographic Description of 324 Women With Breast Cancer Who Utilized Integrative Oncology Medical Services in 2009-2014. a
Includes cohort 1 patients with a signed medical records release and known diagnosis date enrolled in the study before January 1, 2014. All data are from the Cancer Surveillance System.
Table 2 shows the histological characteristics of the 324 breast cancer patients who received IO care. Most (65%) patients’ tumors were infiltrating ductal carcinoma, and only 6% were lobular carcinoma.
Types of Breast Cancer Diagnosed in 324 Women With Breast Cancer Who Received IO Medical Care 2009-2014 in Western Washington. a
Includes cohort 1 patients with a signed MRR and known diagnosis date enrolled in the study before January 1, 2014. All data are from the Cancer Surveillance System.
Table 3 shows the stage of 324 IO breast cancer patients at their first presentation to a participating IO clinic, who consented to participate on an observational outcomes study. Most (57%) of the women were at stage 1 and 2 when they first presented to the IO clinic. Only 3.7% were stage 4 when they presented to the IO clinic.
Stage of Breast Cancer at Study Enrollment? a
Includes cohort 1 patient with a signed MRR and known diagnosis date enrolled in the study before January 1, 2014. Stage was abstracted from the patient’s medical record at study enrollment. If that was not available, then the Cancer Surveillance System stage at diagnosis was used if time from diagnosis to enrollment was <2 years.
Table 4 presents the number of consultations, the main types of IO therapies prescribed during the first year of IO care, and the recommendations that were made to complement standard oncological treatment, which were prescribed at visits that occurred during each woman’s survivorship period.
Frequency of Office Visits and Types of Integrative Oncology Treatments in a Cohort of Breast Cancer Patients Who Received IO Medical Services. a
Abbreviations: IO, integrative oncology; TCM, traditional Chinese medicine; FOC, first office call.
Includes cohort 1 patients from all sites with a signed MRR and known diagnosis date enrolled in the study before January 1, 2014. Stage is what was abstracted from the patient’s medical record at study enrollment. If that was not available, then the Cancer Surveillance System stage at diagnosis was used. Included are the first 12 months of IO recommendations. Consultations are office visits with procedure codes indicating interaction with an IO physician. Consultations were calculated from Bastyr Integrative Oncology Clinic patients only. “In treatment” refers to any patient <1 year postdiagnosis who has a completed IO treatment eCRF dated before the 1-year diagnosis anniversary. “Survivorship” refers to any patient >1 year postdiagnosis.
Table 4 also presents finer detail regarding the timing of specific IO therapies in relation to standard treatment (chemotherapy/radiation) and during the posttreatment survivorship period. Intravenous (IV) therapies were administered mostly after completion of chemotherapy during survivorship. The number of clinic visits per patient per year ranged widely from 1 to 32. The mean number of visits during the first year of IO care ranged from 6.57 (±7.27) in stage 0 to 4.53 for stage 1 and a mean of 5.88 visits in the first year in stage 4 patients.
Of the entire cohort of 324, most (88%; 287) of the women had at least 2 office visits. Table 4 shows that the most frequently prescribed therapies were botanical and nutritional medicines (supplements); 100% of visits that occurred during conventional primary treatment included prescriptions of orally administered natural substances. The other commonly recommended therapies included acupuncture provided by TCM practitioners. Many (49%) of the 287 women in the nested cohort had a consultation with a TCM provider. Of these, most received acupuncture during their first year of IO care. Acupuncture was more likely to be prescribed during the year of primary oncological treatment compared with the survivorship year. TCM herbs were prescribed less frequently than acupuncture. Dietary recommendations were made to 65% of women and lifestyle modifications to 63%. Some form of exercise was the most common lifestyle recommendation. Mind-body therapy was prescribed to 45% of the patients during both the first year of standard treatment and to a similar percentage of women during survivorship.
Table 5 presents details on specific types and frequencies of therapies recommended to 287 breast cancer patients who had at least 2 visits with an ND, FABNO and who enrolled before January 1, 2014, and had at least 2 office visits. Table 5 includes the list and frequency of recommendations for the recommended treatments abstracted from the patient’s IO records. More than 72 specific oral or topical nutritional-, botanical-, fungal-, and bacterial-based medicines were prescribed to the cohort during their first year of IO care. The most common therapy prescribed was standardized capsules of dried extract of Trametes versicolor, which was prescribed to 63% of the women as a chemotherapy-compatible immune therapy.
Types and Frequency of Integrative Oncology Treatments Prescribed to Breast Cancer Patients.
Abbreviations: DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; GABA, γ-aminobutyric acid; IV, intravenous, PSP, polysaccharide peptide.
Includes cohort 1 patients with a known diagnosis date enrolled in the study before January 1, 2014. Included are the first 12 months of IO recommendations. Only recommendations given for >3% of the participants (n = 10) are included.
Includes cohort 1 patients with a known diagnosis date enrolled in the study before January 1, 2014. Included are the first 12 months of IO recommendations. Only recommendations given for >2% of the participants (n = 7) are included.
Other commonly prescribed therapies, in order of frequency, included vitamin D3 (60%), melatonin (49%), omega 3 fatty acids (45%), curcumin (Curcuma longa) (39%), magnesium (37%), coenzyme Q10 (29%), sea weed poultice and/or vitamin E topically for radiation burn (25%), plant and pancreatic enzymes (23%), bromelain (22%),
Of the 287 women described in Tables 4 to 6, 76 (26%) were prescribed some type of injectable therapy. Injectable IO therapies included subcutaneous injections of mistletoe (Viscum album) and a diversity of parenteral therapies that included vitamin B complex intramuscularly (12%), IV high-dose ascorbate (12%), IV artemisinin (7%), and IV nutrition and hydration (4%). Injectable therapies were used almost exclusively in stage 4 breast cancer patients (data not shown).
Costs of Integrative Oncology Care in Women With Breast Cancer (US$). a
Abbreviations: IO, integrative oncology; TCM, traditional Chinese medicine; FOC, first office call.
Cost of IO care for IO patients with 2 or more IO physician consultations. Includes cohort 1 patients from all sites with a signed MRR and known diagnosis date enrolled in the study before January 1, 2014, and who had had at least 2 consultations with an IO physician. Included are the first 12 months of IO recommendations. Consultations are office visits with procedure codes indicating interaction with an IO physician. “In treatment” refers to any patient <1 year postdiagnosis who has a completed IO treatment eCRF dated before the 1-year diagnosis anniversary. “Survivorship” refers to any patient >1 year postdiagnosis who has a completed IO treatment eCRF dated after the 1-year diagnosis anniversary. Office visit mean cost/patient is for consultations only, based on average cost of $238.52 for a first office visit and $137.04 for a follow-up visit. Office visit costs were calculated from Bastyr Integrative Oncology Clinic patient data.
Whereas some patients (20%) were referred for nutritional counseling by a certified nutritionist, most received dietary advice from the IO physician within the visit. Dietary recommendations included increased green tea as a drink (24%), increased vegetables (17%), broth fast (16%), increased protein (13%), increased water (15%), reduced simple sugars (8%), increased fish (7%), and decreased mammalian fat (5%). Some type of mind-body therapy was recommended to 45% of patients. Meditation was prescribed to 15% of the breast cancer patients by their IO physician. Qi gong was recommended to 8% of the women. Yoga was recommended to 9%. The most common lifestyle recommendations made included walking (29% of patients were asked to walk more each day).
Integrative Oncology Cost Data
Table 6 shows the amount charged for all visits for 1 year of IO care in stages 0, 1, 2, 3, and 4 and those of unknown stage breast cancer. Of the total amount billed for 1 year for 287 breast cancer patients, 21% was out of pocket. Insurance reimbursement paid for 39.1%. The remaining 39.5% was written off by the university. The direct costs of care include medical visits (naturopathic oncology consultation and mind-body medicine visits), procedures (acupuncture), and pharmacy. Pharmacy includes nutritional and botanical medicines administered orally, intravenously, subcutaneously, intramuscularly, or topically. Yearly cost for office visits ranged from $512/year to $1084/year. Stage 3 women had the most visits and the highest visit costs compared with women at other stages of breast cancer at diagnosis.
Visits were subcategorized into 2 types: those made by women during the first year after diagnosis with breast cancer—that is, during the treatment year—compared with the second year after diagnosis, which is for most women the first year of postsurgical, postchemotherapy, and postradiotherapy survivorship.
Table 7 summarizes the fees charged for the most common CPT codes billed by ND, FABNO offices in Washington State for E&M clinic visits and procedures, including acupuncture and IV therapy. In Washington State most medical insurers reimburse for naturopathic and TCM medical visits and acupuncture as a medical procedure. These E&M and procedure fees scheduled are set by insurers. Although the infusion therapies delivered by ND, FABNOs are within the scope of their Washington State license, only those administered for rehydration and nutritional deficiencies are billed to the patient’s medical insurance because they are not considered experimental.
CPT Codes and Fees Used (US$) and Insurance Reimbursement for Integrative Oncology Services in Western Washington State.
Abbreviations: CPT, Current Procedural Terminology; mgmt, management; IV, intravenous; DCA, dichloroacetic acid.
We asked the ND, FABNOs to describe an ideal core protocol for IO care for each stage and type of breast cancer. We then calculated the cost of IO pharmacy for 1 year of care for a stage 4 cancer patient. Table 8 presents an IO core therapy program for 1 year of treatment for a stage 4 breast cancer patient. Total cost of the medicines used in this treatment plan for 1 year is approximately $27 137. Parenteral therapies were the most costly of IO treatments, and few stage 4 breast cancer patients completed such an idealized treatment. Total costs (visits and IO pharmacy and procedures) of 1 year of IO treatment for a women with progressing stage 4 breast cancer is approximately $31 662/year. ND, FABNO visits cost approximately $4525/year (see Table 3). Office visits are reimbursed by medical insurance providers, including Medicaid but not Medicare.
Typical Costs (US$) of 1 Year of Idealized Integrative Oncology Medicine for a Stage 4 Breast Cancer Patient.
Abbreviation: IV, intravenous.
Discussion
Naturopathic oncology provided to women with breast cancer included a wide diversity of evidence-based CAM therapies that included acupuncture, nutritional medicines (vitamin D3, acetyl-
The total costs incurred per year for BIORC participants ranged from $1594/year for early-stage breast cancer to more than $5000/year for stage 3 and 4 breast cancer patients and those who could not be staged at FOC. Costs are highest during the postdiagnosis period when standard oncology treatment is occurring and increases with stage at BIORC first visit. Of the total amount billed for IO care for 1 year for 287 breast cancer patients, 21% was out-of-pocket. Insurance reimbursement paid for 39.1%. The remaining 39.5% was written off by BIORC. This level of institutional write off is not unusual. IO clinics commonly expect at least a 35% difference between what is billed to insurers and what insurers pay.
A comprehensive protocol for stage 4 breast cancer includes IV nutrients and botanicals plus oral and topical natural medicine and costs approximately $32 000/year. Regardless of the stage of breast cancer, IO care is low cost relative to conventional oncology costs. Standard cancer treatments may cost as much as $10 000 to $40 000 per month.10,11 These data are a necessary step toward the calculation of the cost-effectiveness of integrative oncology for breast cancer care as clinical outcome data become available over the next 4 years.
Footnotes
Acknowledgements
The authors acknowledge the assistance of Catherine Bereznay, ND candidate.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by the National Center for Complementary and Integrative Health (R01 AT 5873), the Lotte and John Hecht Foundation, and Bastyr University.