Patient Advocate Foundation Survey: Patient and Consumer Views of Brown Bagging and Mandatory Vendor Imposition Report Prepared by The Lewin Group, Inc. January 24, 2003
Patient Advocate Foundation Survey: Patient and Consumer Views of Brown Bagging and Mandatory Vendor Imposition January 24, 2003 This report of the Patient Advocate Foundation survey was prepared by Clifford Goodman and Umi Chong of The Lewin Group.
BACKGROUND Health care costs have grown at an accelerating rate in the last several years, including an 8.7% increase to $1.4 trillion in 2001. While hospital spending contributed the most to overall increases in 2001, prescription drug spending grew faster than any other major spending category. Drug costs increased 15.7% in 2001, following 16.4% in 2000 and 19.7% in 1999. 1 In this environment, health insurers, managed care organizations, and other health plans continue to implement and modify a variety of mechanisms to manage prescription drug costs, including higher multi-tiered copayments, greater emphasis on generic drugs, prior authorization, and use of third-party pharmacy benefit managers (PBMs). Two of the newer approaches used by insurers to manage drug costs that have particular relevance to cancer chemotherapy and supplemental care agents administered by physicians are commonly known as brown bagging and mandatory vendor imposition. While intended to restrain costs and streamline claims processing, these policies could have undesirable consequences for patient access to safe and effective treatments and the potential for adverse health outcomes. Brown bagging refers to the requirement by some health insurers that patients obtain drugs used in their cancer treatment not from their physician s office, but from a retail pharmacy designated by their insurer. Patients pick up the drugs themselves or receive them via mail delivery, and carry them to their physician s office for administration. By designating the source of the drugs, insurers seek to exert greater control on the costs and management of chemotherapy. However, physicians, patients, and others have multiple concerns about drug safety and effectiveness associated with brown bagging. Among these are safety and security of transportation, proper storage, correct mixing procedures, and timeliness of providing medication. Many cancer chemotherapies, including some that are hazardous materials, require special handling to retain their purity and potency. One of the first drugs to be subject to brown bagging was Procrit (Epoetin alfa), used to treat anemia-related fatigue associated with chemotherapy. 2 The potential for mishandling of medications raises concerns about liability action. In some cases, physicians have refused to treat patients who are enrolled in health plans that have brown bag requirements. 3 Citing patient safety, quality of care, and liability concerns, some oncology practices have persuaded payers to withdraw brown bagging requirements, and other practices are considering similar resistance to this practice. 4 Brown bagging is becoming a more prominent and controversial issue in several states, including New York, Missouri, and Florida. In Florida, one major insurance carrier has implemented a brown bag policy and others are following suit. Some smaller plans have begun to institute the practice in New York. 1 CMS. Report details national health care spending increases in 2001. January 8, 2003. www.cms.gov/media/press/release.asp?counter=693 2 Coletti M. Presentation at State Advocates Strategic Session, Patient Advocate Foundation, November 6, 2002. Washington, DC. 3 Bullen N. Presentation at State Advocates Strategic Session, Patient Advocate Foundation, November 6, 2002. Washington, DC. 4 Albertson JB. Uniting to defeat brown bagging. Oncology Issues 2003;January-February:46. Patient Advocate Foundation 1
Mandatory vendor imposition is a similar type of arrangement sometimes referred to as drug replacement programs or chemotherapy drug management programs by health plans. This requires that physicians receive drugs and medical supplies only from a single vendor (such as a PBM) designated by that plan for the care of patients enrolled in that plan. 5 In doing so, health plans intend to secure lower prices and expedite claims processing for the drugs and supplies used by their beneficiaries. For example, this policy is being implemented by UnitedHealthcare plans in Florida, Texas, Ohio, and elsewhere, and by John Deere Health Plan in Iowa. The vendor for injectible drugs designated by the John Deere Health Plan, McKesson Specialty Pharmaceutical, takes responsibility for beneficiary eligibility and bills John Deere Health Plan directly. Through this program, physicians order injectible drugs one dose at a time. 6 This type of policy limits physicians alternatives regarding pharmacy vendors from which to acquire their medications. Since implementation of this policy, some health plans have modified the mandatory requirement, providing physicians with the option of not using the single designated vendor. However, physicians who purchase chemotherapy drugs from vendors of their choice (such as their current supplier) may receive lower reimbursement from these health plans. When faced with the choice of having an imposed source of medications versus the financially difficult option of opting out and receiving reduced reimbursement, physicians may refuse to accept beneficiaries of the health plan. In part to balance the lower payment rates, some payers have indicated that they are increasing payment levels for the procedure codes for administration of chemotherapy drugs by physicians who participate in the health plan. 7 Certain recent events have drawn public attention to the potential for mishandling of critical medications, particularly cancer chemotherapies. One such instance, noted by many respondents to the present survey, is the widely publicized case in Kansas City in which treatment of cancer patients was jeopardized when a pharmacist diluted their chemotherapy drugs. 8 SURVEY PURPOSE In efforts to inform discussion and policy development on these issues, The Patient Advocate Foundation (PAF), in collaboration with other access and provider organizations, developed a 14- question survey of patient and consumer awareness and attitudes regarding these polices. The survey was posted on PAF s website November 27, 2002, and distributed via email to members of PAF s listserv on December 2, 2002. The survey was removed from PAF s website December 18, 2002. All surveys received by PAF by December 18, 2002, were included in this analysis. As of that deadline, PAF received 2,881 completed surveys, including 476 electronic and 2,405 hardcopy (paper) ones. Not included in this compilation were more than 1,000 surveys received by PAF 5 Berger ES, Stevenson C. Revenge of the bean counters? Hematology Oncology News & Issues. January 2003:14-17. 6 Steffens B. John Deere Health. McKesson Specialty Pharmaceutical Injectable Drug Delivery Program. November 20, 2002. (Memorandum to healthcare providers) 7 UnitedHealthcare. Communications to physicians and oncology practices in Florida and Ohio. June 2002, August 2002, December 2002. 8 CBS News. Drug-diluting pharmacist gets 30 years. December 5, 2002. https://publish.cbsnews.com/stories/2002/02/25/national/main330499.shtml Patient Advocate Foundation 2
after the deadline. Other than state of residence, the survey questions did not request other descriptive information about respondents. The survey form is available from PAF. The Lewin Group was contracted by PAF to compile and present the survey results in this brief report. The Lewin Group was not involved in drafting or dissemination of the survey. PAF transmitted the survey data to The Lewin Group. MAIN RESULTS Surveys were received from respondents in 38 states. The five states with the highest numbers of responses were: Texas (24.5% of responses), Oklahoma (12.3%), Virginia and Florida (both 9.4%), and Nevada (7.4%). These five states accounted for more than 60% of the total number of responses. Notably, two of these five states, Texas and Florida, are among the states in which mandatory vendor imposition has been implemented. Another, Iowa (3.4%), ranked tenth among the states in number of survey responses. As a group, the respondents were familiar with chemotherapy. About half of respondents (51%) reported having had chemotherapy currently or in the past. Nearly three-fourths (73%) reported that a friend or family member has had or was currently receiving chemotherapy. For those having direct or indirect experience with chemotherapy, 72% reported that the principal place where the chemotherapy was administered was the physician office or community cancer center. Another 26% reported that the chemotherapy was administered in the hospital outpatient setting. Concerns with Brown Bagging Among all respondents, the survey results indicate that few patients report having had direct experience with brown bagging, but nearly all have multiple concerns about the implications of this policy. Only 3% reported being required to pick up chemotherapy and/or supportive care drugs at an outside pharmacy and take them to their physician for administration. However, when posed with the possibility of having to brown bag their chemotherapy, or having already experienced this, 83% of respondents answered that they would be concerned and another 9% would be somewhat concerned. Only 7% of respondents answered that they would be neutral or unconcerned regarding this situation. Among those 92% of respondents who reported that they would be concerned or somewhat concerned with mandatory vendor imposition, the great majority indicated that they would have each of the following multiple concerns among those listed in the survey. Potential danger that the drugs could be harmed during transport (90%) Inconvenience of going to the pharmacist before going to place of treatment (88%) Uncertainty about how to properly handle drug while in one s possession (85%) Financial responsibility for payment at time of picking up the drug (83%) Interference with the physician-patient relationship (78%) Patient Advocate Foundation 3
Potential risk of receiving compromised drugs (74%) Uncertainty about disposal of hazardous waste (73%) Concerns with Mandatory Vendor Imposition Similar to the responses for brown bagging, only 3% of the respondents reported knowing that their physician was mandated to use a designated pharmacy carrier. Half of the respondents did not know whether their physician was subject to mandatory vendor imposition. Approximately 45% of the respondents did not think their physicians were subject to this policy. When posed with the possibility of having their physician being required to obtain medical supplies and medications from a designated third-party vendor, 75% of respondents answered that they would be concerned and another 12% would be somewhat concerned. Only 12% of respondents answered that they would be neutral or unconcerned regarding this situation. Among those 87% of respondents who reported that they would be concerned or somewhat concerned with mandatory vendor imposition, more than 80% indicated that they would have each of the following multiple concerns among those listed in the survey. Potential delay in treatment due to late or incorrect drug delivery (92%) Clinical inflexibility, such as waiting for drug delivery before beginning treatment and limited ability to adjust treatment to changes in patient condition (90%) Potential danger that drugs could be harmed prior to receipt by physician (88%) Potential risk of receiving compromised drugs (87%) Potential that physician may no longer be able to treat you (85%) Administrative or financial hardship for clinicians and their practices (84%) Imposition of third party between patients and their clinicians (82%) OVERARCHING IMPACTS AND THEMES When asked to consider the effects of insurance company policies such as brown bagging and mandatory vendor imposition, 87% of respondents indicated that they could interfere with patients access to care and 90% indicated that they could impact the quality of care patients receive. Another 6% and 7%, respectively, indicated that they did not know whether these policies would have these effects. When asked whether insurance companies should pursue such policies, an overwhelming majority, 84%, answered that insurance companies should not. About 9% indicated that they did not know if insurance companies should pursue these policies, and 6% were in favor of such policies. Eighty-six percent of respondents indicated that they would not choose a health insurance company that pursued such policies as brown bagging and mandatory vendor imposition. About 9% said they did not know if this would affect their choice, and 4% said that they would choose an insurer that pursued these policies. Patient Advocate Foundation 4
The surveys included space for comments from respondents. Most of these comments addressed the following four main themes. Interference with patient-physician decision making. Brown bagging and mandatory vendor imposition adversely affect medical decision making and the patient-physician bond. The relationship between patients and physicians must be respected and preserved. Insufficient health plan qualifications; potential conflicts of interest. Insurance companies and other health plans lack the qualifications for, and may have conflicts of interest regarding, imposing requirements that limit physicians ability to provide drugs to their patients. Inconvenience and burden. The greatest burden of brown bagging is inconvenience to cancer patients and their caregivers. Brown bagging and mandatory vendor imposition sap precious time and energy of people who are already very ill and undergoing rigorous and often debilitating treatments. Potential for mishandling and tampering. Patients are not trained or equipped to handle such chemotherapeutic agents, and are very concerned about the possibility of tampering. Given the limited choice of vendors and the decrease of control over the medications by their physician, there is greater likelihood for such adverse scenarios. Illustrative Comments by Main Theme Respondents comments representing each of these main themes are provided below. Interference with patient-physician decision making This proposed Brown Bag Policy represents poor quality medical care for the patient. It also directly interferes with the doctor-patient relationship, which is one of the cornerstones on which our superior American health care system has been based. Acceptance of Brown Bagging will lead to inferior health care I want no part of it. I feel that the insurance companies are crossing the line and interfering with proper medical care and coming between the doctor and patients. Cancer treatments are frightening enough without an outsider imposing on the relationship between patients and their medical support staff. Insufficient health plan qualifications; potential conflicts of interest We pay high premiums for quality insurance. We should have quality insurance without the insurance company dictating the quality of care that is received. The insurance companies need to just let the physicians and nurses do their job and refrain from trying to find ways to weasel out of reimbursement. Please let the doctors prescribe treatment stop insurance companies from practicing medicine. Patient Advocate Foundation 5
I feel that the people making the decisions are not medically in tune to the needs of the patients. Decisions are made by non-medical personnel and often inconsistent. The quality of care is more important than the quantity of care! Treatment and the process should be left to the doctor and the patient. Our rights are being impeded by [the] corporate profit margin. I don t want insurance companies to play doctor. I think we should leave the doctoring to those who know what they are doing. Inconvenience and burden Having cancer and multiple cancer treatments are extremely difficult emotionally, mentally, and physically. The worry, concern, and logistics of all of it are tremendous. To add one more concern and inconvenience could be without being over dramatic, devastating. I feel that it is an obvious decrease in patient care to place more burden and responsibility on these patients who are usually already overwhelmed and ill. It s a shame for insurance companies to ask people that are already ill and at risk, to have them make an extra stop to get drugs that are readily available at the site they are going to. As a daughter of a breast cancer survivor, and because of my work I think that this would make the chemotherapy process harder on the patient and family. It would be an emotional strain on them. And from what I see at our center, it can take time to prepare a solution and the patients do not need this additional stress of worrying whether is has to be refrigerated, can they go pick it up a day before and still be good to use a day later, can it be out in the heat? Some of our patients use public transportation or rely on family members to bring them to chemo, now they would have to find a ride to the pharmacy? Potential for mishandling and tampering I think you are just asking for errors to occur when you split up the pharmaceutical end of treatment from the site of administration. It is poor quality of care and the opens up huge areas for potential lawsuits. As a pharmacist, I can tell you without hesitation that the overwhelming majority of pharmacies would not even order these types of drugs, due to cost, transportation, storage, and dispensing problems associated with them. Just one tainted batch of chemo drug can spell doom for a cancer patient. The safety of our patient would be in great jeopardy. How would a dosage of medication be ordered and given on the same day? The patient would have twice as many office visits so medication could be ordered and then administered when it arrives. What if the medication is damaged in shipment- patient care is again delayed. Patient Advocate Foundation 6
As an oncology nurse and a family member of a cancer patient, I am very concerned about the proposed policies. The situation of the pharmacist in Kansas who diluted drugs can possibly become more widespread as private pharmacists are given more power. Let the physicians order their own drugs and let the physicians be the responsible party for their patients. This make[s] for more secure checks and balances. Chemo is not safe and transporting it in a car is bad practic e, not all [drugs] are stable long enough. Nurses cannot give drugs that are out in the community and they have no control of sterility etc. My father is a pharmacist and believes that there is a substantial risk in off-site preparation of chemotherapy drugs. It certainly diminishes the ability of the nursing staff to check what medication has been added to the IV solution. SUMMARY OBSERVATIONS Brown bagging and mandatory vendor imposition are related types of policies that have been implemented by health plans in an effort to decrease costs and improve the efficiency of claims processing associated with chemotherapy drugs. These are among the more recent of a variety of mechanisms intended to manage health care costs, and pharmaceutical costs in particular. In cooperation with other interested groups, The Patient Advocate Foundation developed and disseminated a survey on these issues during a three-week period in late 2002. Nearly 2,900 surveys from 38 states were completed and returned to PAF by the submission deadline. Half of the survey respondents had personal experience with chemotherapy, and nearly threefourths reported that a friend or family member had received chemotherapy. While only 3% of respondents reported having direct experience with brown bagging, 92% expressed concerns about an actual or potential requirement to brown bag their chemotherapy, with very high response rates to particular concerns such as the danger that drugs could be harmed or mishandled and inconvenience for ill patients. Similarly, only 3% of respondents reported knowing that their physician was subject to mandatory vendor imposition, although half of the respondents did not know whether their physician was subject to this policy. Nearly 90% of respondents expressed concerns about an actual or potential requirement for mandatory vendor imposition, with very high response rates to such particular concerns as delays in treatment, clinical inflexibility, and danger that drugs could be harmed or compromised. Nearly 90% indicated that these policies could interfere with patient access, and 90% indicated that they could affect quality of care. Respondents attitudes about insurers that would implement these policies were decidedly negative; 84% indicated that insurers should not pursue such policies and 86% said that they would not choose a plan that used these policies. Based on respondents answers and written comments, the most common themes of concern across the two chemotherapy management policies were: interference with patient-physician decision making; insufficient health plan qualifications, including potential conflicts of interest; Patient Advocate Foundation 7
inconvenience and burden for patients and caregivers, and potential for mishandling and tampering. The results of the survey provide a snapshot of patient and consumer awareness and attitudes regarding brown bagging and mandatory vendor imposition. As in any survey, the responses represent the views of those who were aware of the survey and chose to respond to it in the available timeframe. Nevertheless, the distribution of responses among these respondents, who as a group had appreciable experience with the burdens associated with chemotherapy, indicates very strong attitudes in opposition to the policies of brown bagging and mandatory vendor imposition, and to health plans who may pursue these policies. It is important to note that the implementation of these policies is relatively recent and in flux. Further, such companies as UnitedHealthcare and John Deere Health Plan have made, or appear willing to make, some modifications to them based, at least in part, on reactions of individual physicians, oncology practices, other providers, and patient groups. This suggests that now is an opportune time to pursue informed, constructive communication among these parties. In this manner, they can meet the considerable challenge of providing cancer chemotherapy that is at once cost-effective and well-managed without compromising patient access, safety, and clinical effectiveness. Patient Advocate Foundation 8