QIO Conference - Narrative of Proceedings

A working conference convened by the Center for Medicare Advocacy, Inc., supported by the Commonwealth Fund, a New York City-based private foundation, and AARP

On January 19, 2007, the Center for Medicare Advocacy, Inc. convened a working conference to formulate a model for resolving Medicare beneficiaries’ complaints about quality of care. The Commonwealth Fund supported the conference, with additional support from AARP.

The Center’s conference was triggered in part by the Institute of Medicine’s comprehensive study of Medicare’s beneficiary quality of care complaint process, operated under contract with Quality Improvement Organizations (QIOs). [Institute of Medicine, March, 2006][1] As a result of its findings, the IoM recommended removing from QIOs the function of performing quality of care complaint investigations. The IoM recommendation would allow QIOs to focus on assisting health care providers in quality improvement. The 2006 IoM report builds on earlier recommendations for improving the complaint resolution function. The IoM and others have on many occasions called for a beneficiary-focused complaint review process to address the concerns of beneficiaries about quality of care. Central to this call has been a finding that the QIOs are primarily provider-focused, assisting providers in quality improvement activities, rather than beneficiary-focused.

Medicare beneficiaries and their advocates are concerned that the current (QIO) process for resolving beneficiary complaints about quality of care has not been effective in providing fair and timely resolution of complaints. Concerns about the process include an inadequate resolution of beneficiary complaints about poor quality, a lack of information about proper care protocols, and the failure to provide expedited review of denials of care.

The Center’s QIO conference provided an opportunity to obtain analytical papers about the problems with the current Medicare quality complaint system and to consider possible solutions. The conference itself provided a forum for key stakeholders to discuss these matters and to begin to develop a blueprint for change.

Prior to the conference, the Center commissioned three background papers to provide a framework for discussing the topics at hand. The first paper, written by senior attorneys from the Center for Medicare Advocacy, presented a brief history and an overview of the current Medicare beneficiary complaint process. The second paper, written from the perspective of a physician, examined and assessed the attributes of an ideal complaint process, regardless of the entity performing the review function. The third paper, written from an and academic legal perspective, explored possible alternative entities that might handle the complaint process function, including existing entities and a potential new entity. The papers were made available to the conference participants one week prior to the conference. Participants were asked to read the papers as part of their preparation for the conference.

Further, the background papers and other materials were made available on a dedicated page of the Center’s website, providing conference participants ready access to background materials, including a summary of the IoM report, relevant chapters from the report, information about the conference and its participants, and suggested readings.

Forty-two invited experts from across the country participated in the working conference. Participants came from a diverse set of disciplines: beneficiary advocates, professors of law and public policy, attorneys, medical doctors, policy researchers, industry representatives, government officials, Congressional staff members, and representatives of various agencies that handle complaints.

The day-long conference was divided into four sessions. The first session provided an overview and an opportunity for the authors to present their papers.

The first presentation was given by Sally Hart, J.D., M.B.T., attorney with the Center for Medicare Advocacy. She and Toby S. Edelman, Ed.M., J.D., attorney with the Center for Medicare Advocacy, wrote a short paper that summarized the current complaint process. Ms. Hart presented the history of the complaint process, with a particular emphasis on the governing statute. She reminded participants that changes to the complaint process entity and its responsibilities would require statutory changes.

Ms. Hart also presented information about past critiques of the QIOs’ performance, including two reports from the IoM and two reports from the Department of Health and Human Services’ Office of the Inspector General. She concluded her presentation with a discussion of the responses to the 2006 IoM report from the Centers for Medicare & Medicaid Services (CMS) and from the American Health Quality Association (AHQA), the group that represents QIOs.

2. Elements and Considerations for Developing a Medicare Beneficiary Complaint Process to Address Quality of Care Concerns: Medical Perspective

Peter A. Hollmann, M.D., geriatrician and assistant Clinical Professor in Family Medicine at Brown University; and medical director of Blue Cross Blue Shield of Rhode Island, presented his paper. Dr. Hollmann offered four conclusions: (1) Conference participants should set realistic expectations; (2) No current entity has all of the desired attributes; (3) Alternative Dispute Resolution (ADR) should have a place in the complaint system; and (4) Fragmentation in the system creates waste and reduces efficacy. Dr. Hollmann examined the various components of a complaint system, including access, investigative capacity, timeliness, interventions and follow-through, quality improvement, responsiveness, substantive information, confidentiality, availability of, and process for, an ADR option, objectivity, accountability, and efficiency. He also stressed that the system should not demand a specific number of complaints or sanctions against doctors, a provision that would be unacceptable to the provider community.

Diane E. Hoffmann, J.D., M.S., Professor of Law, Associate Dean for Academic Programs, and Director of the Law and Health Care Program, University of Maryland School of Law, and Virginia Rowthorn, Esq., director of Health Law Externships, coordinator for the Law and Health Care program, and Lecturer in Law at the University of Maryland School of Law, presented their paper. Ms. Rowthorn presented structural details about the current complaint system, including a flow chart of how the complaint process proceeds generally.

Dean Hoffmann presented slides to the group about potential alternative entities to handle the beneficiary complaint review function. She examined state survey agencies (SAs) and state medical boards (SMBs) in detail and contrasted each entity with the QIOs in terms of how effective they would be at the complaint review function. She also described how a joint effort between the two entities might look. Dean Hoffmann presented three conclusions: (1) As the IoM report stated, there is a need for a “new home” for the beneficiary complaint response function; (2) The proposed alternative takes advantage of the expertise of the SAs and SMBs in responding to patient/consumer complaints; and (3) Neither the QIOs nor the proposed alternatives represent an “ideal” process.

In the second session, information about beneficiary knowledge about health care and health access and cultural literacy was presented, with particular attention to the characteristics of those likely to use the complaint system. Ms. Edelman introduced the session. She asked the group to consider that the complaint process system should be uniform and consistent while also being sensitive and flexible to diverse beneficiaries.

Joyce Dubow, senior advisor in AARP’s Office of Policy and Strategy, gave the first presentation. She presented demographic information about Medicare beneficiaries including a profile of current beneficiaries, and data about the ethnic distribution of beneficiaries, their financial means, and their health status. Ms. Dubow also spoke about health literacy and beneficiary knowledge of the Medicare system. She noted that many Medicare beneficiaries admit that they know little about the Medicare program as a whole, let alone complaint processes. She asked that any new complaint system take into account the issues she raised and that materials use simple language and be “age-appropriate.”

Ho Luong Tran, M.D., M.P.H., President and CEO of the Asian and Pacific Islander American Health Forum, was the second presenter. She works closely with the Asian-American community and described some of her experiences as a physician and advocate in that community. She said that she asked her client community if they were aware of the Medicare quality of care complaint process and whether they would use it. Dr. Tran reported that 90% of the people she asked did not know of the complaint system. Furthermore, of those who did know such a system was available, many said they would be unlikely to use it. Several reasons for not using it were given, including fear of retaliation, poor English fluency and lack of translators, and cultural constraints that suggest that complaining is disrespectful to those in authority.

Dr. Tran used two stories to illustrate her points about cultural issues and cultural literacy. The first related to when she was living in Chicago. One snowy night a Vietnamese man showed up at Dr. Tran’s door with his mother on his back. He did not know what to do or whether his mother’s heath situation was critical. When Dr. Tran asked why he had not called an ambulance, he said he did not speak English well enough. Later, when Dr. Tran went to visit the man’s mother in the hospital, she found the woman crying. When Dr. Tran asked why she was crying, the woman replied that she had felt hungry all week because she did not know whether she should eat the hospital food and her son had been at work when the food was delivered. Dr. Tran asked the conferencees if the hospital’s failure to rectify this individual’s concern about eating their food was something that could be considered a “quality of care” complaint.

Dr. Tran’s second story involved a person who was dually eligible for Medicare and Medicaid and in a Medicare Part D prescription drug plan. The plan sent the beneficiary a letter which she put unopened in her closet. The letter, written in English without translation, was to inform her that her co-payments were rising from $2 to $3. She did not open the letter because she could not read it, although later she brought it to someone who could read and translate the letter for her. Dr. Tran asked the group to consider cultural issues and beneficiaries’ concerns when drafting a complaint model. Her question - “Are we ready to answer a phone call in Vietnamese?”

Diane F. Paulson, Esq., senior attorney with the Medicare Advocacy Project of Greater Boston Legal Services, was the next speaker. Ms. Paulson represents poor Medicare beneficiaries. She agreed with Dr. Tran’s comments, although she noted that for many of her clients, language is not the issue. Her clients are not aware of the complaint system, and for similar reasons to Dr. Tran’s associates, her clients will not complain. Ms. Paulson said that her clients, although English-speaking, are still unable to comprehend the letters that are sent to them. She closed by saying that we need a complaint system that will work and be user-friendly.

The third session allowed for discussion among all participants about the nature of the complaint review process, what it should entail, and which entity should be in charge of it. Alfred J. Chiplin, J.D., MDiv., attorney with the Center for Medicare Advocacy, moderated this discussion. The agenda of the session was laid out in a document with the same name as that of the session. Prior to the conference, participants were asked to review this document and to think about the questions it presented. Several participants were also asked to give particular attention to one of the main topics so as to facilitate discussion. The resulting discussion is incorporated below and divided into sections based on the topic to which the comments related.

The day ended with a wrap-up session that discussed the points of consensus and outlined next steps to be taken. Judith A. Stein, Esq., Executive Director of the Center for Medicare Advocacy, moderated this session. Ms. Stein guided conferees through a review of what was said during the day and brought participants together on a consensus model of an ideal beneficiary complaint process. That model provides the basis for the rest of this document, beginning with areas of agreement among participants and ending with those issues that were unresolved. The comments that were made during the discussions in Session III are presented below. Comments and discussion have been grouped within the respective topic to which they relate so that the reader has a cohesive picture of the model’s elements, rather than a strictly chronological narrative.

One participant suggested that complaints can be grouped into three categories: qualitative, clinical, and medical error. Qualitative complaints are those where a patient feels that he or she has been shown disrespect or his or her opinion has been discounted. Clinical complaints include matters where the beneficiary feels that the care did not meet appropriate standards, even though he or she experienced no specific, identifiable physical harm. It was pointed out that in most circumstances of this sort, it is difficult, if not impossible, to say what the appropriate care should have been. The third category involves events where the beneficiary was clearly harmed. This category encompasses egregious cases or “never events” (events that should never happen), as well as infections and other major errors.

There was consensus that an ideal system would be able to accept and document the broad array of potential complaints. It would also be flexible enough to allow for an appropriate method of resolving the complaint, based on its severity and other factors.

Participants agreed that anyone should be able to file a complaint. One access barrier in the current system is that someone calling on behalf of a beneficiary is often lost to the complaint process. The Medicare Part D plans and the staff at 1-800-MEDICARE, for example, do not want to talk to family members. To file a complaint, one needs to be able to say, “I’m the guardian,” or “I have health care power of attorney.” Janet Wells, director of Public Policy for the National Citizens’ Coalition for Nursing Home Reform (NCCNHR), also raised the point that many people in nursing homes have dementia or are perceived as having dementia and their complaints are often not taken seriously.

Questions were raised about the need to protect patient confidentiality and for institutions to comply with the Health Insurance Portability and Accountability Act (HIPAA). Dr. Hollmann, for example, mentioned that the provider he works for accepts complaints from family members, but does not provide them with complete details about the case when it involves patient-specific information. Michael Connors, an advocate with California Advocates for Nursing Home Reform, pointed out that in California anyone can file a complaint against nursing homes and the investigator must respond to the complainant and provide documentation of the survey that took place, which becomes part of the public record. One question that was not answered in the California approach concerned the ranking of complaints, i.e., that a complaint filed by a beneficiary would be of more weight than one filed by a family member.

There was agreement that health care workers should be able to file complaints and that they should be able to do so anonymously. State medical boards, for example, receive complaints from pharmacists. Wendy Kronmiller, J.D., Director of the Office of Health Care Quality in the Maryland Department of Health and Mental Hygiene, noted that the Maryland state Survey Agency gets “good information from staff.”

There was consensus that an ideal system would receive and follow through on complaints from beneficiaries, family members, advocates, health care workers, and anyone else with important information. The system would need the means to protect the anonymity of staff and comply with HIPAA.

Drawing on the presentations that were made in Session II, participants agreed that the ability to file a complaint should not be constrained by language, literacy, or technological barriers. Many people in attendance expressed concerns that numerous barriers and obstacles prevent Medicare beneficiaries from filing complaints. Several participants commented that many beneficiaries do not know where to file a complaint and that the requirement that a complaint be in writing poses a serious obstacle for many people in the beneficiary community. Sheila Blackstock, R.N., B.S.N., J.D., Director of the Division of Quality Improvement Program Policy for Acute Care within the Quality Improvement Group at CMS, pointed out that anyone calling 1-800-MEDICARE who wishes to file a complaint will be referred to the appropriate QIO, which will work with the caller over the phone to fill out the written complaint and mail it to the person to sign and return to the QIO.

With respect to the use of the Internet and computer-based complaint processes, there was agreement that such technology has its place but should not be relied upon to the extent that it becomes an access barrier for those who either do not have the technology or lack the skills to use it. Similarly, such systems should be available to people who speak a variety of languages and at all levels of literacy. Also, the complaint process should utilize materials that are age-appropriate, and should recognize that primarily internet-based systems are not effective with the current Medicare beneficiary population.

Participants agreed that the primary goal of the complaint process system should be to address and resolve beneficiary concerns. Currently, the QIOs have two main functions: a feedback management function to allow for provider quality improvement and a beneficiary service function to respond to individuals’ complaints about quality of care. Our focus was implementation of the March, 2006 IoM recommendation to remove the complaint function from QIOs.

In sum, participants agreed that there is no obvious entity that works solely in the interest of advocating for the beneficiary in the quality of care process; such an entity is needed.

2. Secondary Goal: Identifying Provider Opportunities for Quality Improvement

In addition to focusing on the beneficiary, participants also recognized the importance of utilizing complaint information to identify problems, particularly those that are systemic. Mark Yessian, Ph.D., a recently retired researcher and investigator at the Department of Health and Human Services’ Office of the Inspector General (OIG), posed the following question to the group: “How important is a complaint system?” This centrally important question brought forth a variety of views. In sum, it was agreed that the complaint system is an overarching part of a system’s quality control and a key to the proper function of any system that delivers a service.

In a report written while he was with the OIG, Dr. Yessian called the Medicare quality complaint process a “safety valve.” He reiterated this term at the meeting and the group agreed with this analogy. Moreover, the group noted that a complaint system that is well-executed can unearth important issues about quality. David Schulke, Executive Vice President of the American Health Quality Association (AHQA), the national organization that represents QIOs, supported Dr. Yessian’s point, adding that the issues that beneficiaries complain about often turn out to be key predictors of real problems. Ms. Kronmiller agreed, adding that her agency has found significant systems problems as a result of beneficiary complaints. Mr. Schulke also quoted a study which found that roughly 30% of complaints were about negligence and 70% were about systemic flaws.

In summary, the participants agreed that a well-publicized complaint system that keeps detailed records can serve two purposes: (1) It can help identify problems with specific providers and (2) It can identify areas where a specific provider or all providers can improve their quality.

Participants agreed that a principal problem with the current complaint process is that few beneficiaries are aware of it. Moreover, when beneficiaries do complain, they are not provided ongoing or updated information on their claim or help in finding or navigating their way through the complaint system. Ms. Stein suggested that there should be a single point-of-entry for beneficiaries—one number for beneficiaries to call regardless of where they live. She suggested that it could be a system similar to other government-run phone numbers like “3-1-1” in New York City or “2-3-3” in Connecticut. Participants were not able to agree on whether a new or existing entity should provide this service.

Chad Boult, M.D., M.P.H., M.B.A., Director of the Lipitz Center for Integrated Health Care and Professor of Public Health at the Johns Hopkins Bloomberg School of Public Health, suggested a “Patient Advocate Link,” or PAL, as an instrument for navigating the complaint system. This would be a new entity that would provide customer service to Medicare beneficiaries seeking to file a complaint about the quality of Medicare-covered services. The PAL would be in local offices and would not duplicate the functions of other helper entities, such as the ombudsman program. Rather, the PAL would be an outlet for the beneficiary for purposes of advice about options or assistance in making preliminary inquiries about quality of care concerns and to facilitate provider feedback Many participants felt that the PAL and ombudsman functions were essentially the same. It was noted that the PAL would not investigate and would not make decisions of right and wrong, but would make referrals, listen to the beneficiary, and keep the beneficiary informed of the progress of the complaint. Dr. Boult likened the proposed system to the customer service systems of many businesses, including the renowned Marriott system.

The PAL idea was well received. Nonetheless, some participants pointed out that the PAL system sounded like functions performed by organizations such as the broad network of local State Health Insurance Assistance Programs (SHIPs) or Health Insurance Counseling Programs (HICAPs) and Area Agencies on Aging (AAA), all of which provide one-on-one counseling and assistance to Medicare beneficiaries. It was also pointed out that there is a 1-800-MEDICARE, which is already well-publicized.

Many participants felt, however, that existing organizations do not perform the patient-advocate function envisioned for a PAL, and could not unless additional and more extensive training and funding is provided. Ms. Dubow commented that the PAL-type system should be consistent and uniform for all Medicare beneficiaries regardless of where the beneficiary lives. She also pointed out that some states have better programs than others but that a federal law should act as a common floor.

Concerns raised about the funding of a PAL, or other, single point of entry system and whether it would be effective if it did not have regulatory capacity. Eric Carlson, J.D., an attorney at the National Senior Citizens Law Center, found the idea appealing but likened it to the SHIPs (or HICAPS) or the Medicare Ombudsman. Mr. Carlson said that the PAL is a good idea, in theory, but he had concerns that it would not be effective in practice. The PALs could talk to the provider, but if the provider ignored the PALs, there needs to be some recourse or consequence.

Dr. Boult agreed that the PAL program would need to have teeth to make it effective. Eleanor Kinney, J.D., M.P.H., Professor of Law, Indiana University School of Law – Indianapolis, suggested folding administrative medical malpractice review into the system, as that would give the complaint managers some authority.

Sarah Lock, Esq., Senior Attorney/Manager with AARP Foundation Litigation, suggested three qualifications for a review entity. She suggested that the entity must (1) be independent; (2) have sufficient resources; and (3) be sustainable. Other participants suggested a system similar to one used in the corporate world, where employers hire a for-profit organization that has advocates who maintain a caseload and help employees with problems.

Setting aside the question of what entity would serve as a point of contact for a beneficiary complaint process, participants considered the important features that would comprise a complaint process as follows:

The first function would be to conduct intake and to review the information. Participants agreed that the first person to answer the phone has to be one of the most capable staff members. Intake specialists must be efficient, respectful, culturally competent, and patient. A key problem with 1-800-MEDICARE is that the people who answer the phones give information from predetermined scripts. Ms. Kronmiller noted that her staff has two intake specialists and they are best at conducting intakes and triage.

The next step in the process would be the referral of the case by an intake specialist. The referral of the case must be to the appropriate person or entity for investigation and resolution. It may be appropriate to refer the complaint to the state survey agency or the state medical board. If a case involves abuse, the intake specialist might contact the appropriate law enforcement agency. The discussion focused on state survey agencies and on medical boards because these entities, while not perfect, were the primary resources identified by Dean Hoffmann and Ms. Rowthorn, in the preparation of the background paper on legal issues, as having more of the relevant expertise and capacity to receive and evaluate complaints about quality of care.

Participants supported the idea of having each beneficiary assigned a case manager and given the case manager’s direct-dial number. In addition, each complaint would be tagged with a confirmation/identification number. This would allow the beneficiary to get updates about the status of the case and also maintain the relationship with the case manager. The case manager would make sure the complaint is directed to the appropriate agency and would work to assure that the complainant does not fall through the cracks. Mr. Connors wanted to make sure that the case manager was not a substitute for an investigator.

The complaint information should be entered in a centralized database. All of the participants agreed that this would be a valuable tool in identifying patterns and trends. Many participants questioned why this kind of information is not already available. Ms. Blackstock informed the group that CMS reviews the data that it receives from QIOs, but that compiling and analyzing this information has proven difficult.

As to the question of access to the database information, there was disagreement about how much information should be disclosed and to what person or entity. There was also disagreement about preserving provider anonymity and to what extent. In addition, there was not agreement on whether the database information should be available to consumers and for what purposes, including reviewing the complaint history of a certain provider.

The majority of the day’s discussion focused on what entity or entities should be ultimately responsible for investigating and resolving beneficiary complaints. Suggestions ranged from the use of one clearly defined entity that is in charge of investigating complaints and imposing appropriate sanctions to a combination of multiple entities, each of which would be available for different tasks based on its particular strengths. The entities that were suggested included physicians or other clinicians, state agencies, state medical boards, QIOs. Other potential entities also exist or could be developed as an overall review entity or as an entry point for individual concerns.

Participants who favored a single entity responsible for handling all complaints considered it important to have someone who was ultimately accountable. Mr. Connors, for example, said that he would like to see a primary investigative agency that has the appropriate resources and tools. He preferred this approach to using multiple agencies that might argue about jurisdiction or other issues and thus slow down overall complaint response time. Mr. Connors also felt there is no need to harmonize all separate entities just because they exist. Carol Jimenez, Esq., attorney from California, had reservations about a single, federal complaint process. She asked the group to keep in mind that a broad federal program might discourage many of the positive state programs that are currently in effect.

Robert Berenson, M.D., senior fellow at the Urban Institute and former official at what is now called the Centers for Medicare & Medicaid (CMS), and Dr. Yessian agreed that the majority of complaints currently go to medical providers. Ms. Dubow pointed out that it is often simplest for a patient to complain to his or her doctor or insurance plan because of the frequency of patient contact. In her view, the responsibility to respond to beneficiary complaints should remain with the doctor or plan. Dr. Berenson agreed and suggested that the complaint process, within insurance plans and hospitals, is closely monitored, perhaps by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), now “The Joint Commission.” Moreover, Dr. Berenson ventured that this process would be difficult to execute for small physician practices as they do not meet Medicare Conditions of Participation. Kenneth Dardick, M.D., family physician from Connecticut, asked participants to consider that, in his experience, insurance companies are not very responsive to beneficiaries or physicians. Dr. Dardick felt that a neutral, third-party entity, would be more successful in handling the complaint system.

Participants also considered the SAs as a potential entity for complaint resolution. State agencies receive a broader range of complaints although Ms. Kronmiller said that the majority of complaints received by her office are “quality of care” complaints. It was identified that one of the best attributes of SAs is that in cases where a complaint requires an immediate response, the SA can investigate the complaint quickly—within two days of receiving it in the State of Maryland, Ms. Kronmiller’s state. She, nonetheless, was concerned that a collaborative effort might hinder the agency’s ability to investigate within two days. Further, she noted that SAs are already being asked to investigate groups of providers that are beyond their original scope, and that SAs do not have funding for these additional tasks.

SMBs were also considered as a potential entity. Lisa Robin, Vice President of Government Relations, Policy, and Education for the Federation of State Medical Boards, explained that medical boards were the primary investigative agency at one point and that many are frustrated because they believe they do not receive the reports that they should and cannot take action unless they get a report. She noted too that SMB personnel are usually a mix of people with law enforcement skills and medical knowledge. Participants generally agreed that this mix of skills strikes a proper balance.

Ignatius Bau, J.D., Director of Culturally Competent Health Systems at the California Endowment, pointed out that SMBs are an important way in to the individual physician’s office but that there is a challenge in utilizing this entity because the SMBs are not federally regulated. He felt that it would be difficult to create national standards across states, and that investigators from the SMBs would not have the authority to impose federal sanctions. Ms. Hart opined that standards could be imposed on all physicians if the standard were a condition of participation in the Medicare program.

Mr. Schulke pointed out that the QIOs are not able to promote their own telephone hotlines and that this has weakened their ability to inform people of their services. Ms. Stein commented that the Connecticut QIO goes by the name “Qualidigm” which makes it difficult for beneficiaries to know what service it is that this QIO provides. While acknowledging Ms. Stein’s point, many participants agreed that the QIOs serve a valuable purpose in assisting providers with quality improvement efforts.

Representatives from AHQA pointed out several times that a majority of medical errors are the result of systemic problems, and that addressing systems errors is a major part of what QIOs are designed to do. It was suggested that a hybrid approach with multiple entities might include the QIOs, particularly as an entity that receives referrals to assist providers after an investigation of the complaint is completed.

Participants also considered other entities as potential complaint investigators, including the recently-created Office of the Medicare Ombudsman. Ms. Blackstock informed the group that the office is rather small at the moment. Ms. Lock suggested that the office could be expanded and could conceivably take on the role of handling beneficiary complaints.

Dean Hoffmann suggested a hybrid approach that would combine many of the entities that already exist. Dr. Yessian supported a hybrid approach, commenting that it would be successful if each entity focused on its respective specialty.

Mr. Schulke and others liked the idea of a hybrid approach. There was not enough time, however, for the details of how such a system might function in practice. In addition, there was not agreement in favor of such a system. Mr. Connors and Mr. Carlson, for example, were concerned that dividing the duties might dilute the weight of the authority of a particular entity in resolving complaints and thus ultimately hinder complaint investigations. They were concerned that continuing to focus on quality improvement was distracting from the primary goal of resolving a beneficiary’s complaint.

Dr. Yessian commented that the United States has a highly-fragmented health care delivery system and an increasingly diverse population, with a heavy reliance on the private sector. He asked the group not to expect rationality from a complaint process in this system where multiple levels of redundancy and variations across states can be positive attributes. He agreed, however, that there could be an important role for the PAL or another such entity to help the beneficiary navigate this system. Mr. Chiplin suggested that a demonstration project might be appropriate and could be funded by CMS.

Participants agreed that the data that are gathered by the complaint system should be used for quality improvement purposes, something that the QIOs are best suited to handle. Ms. Edelman pointed out that the primary purpose of the complaint system is to respond with a satisfactory answer to the beneficiary and that quality improvement should be secondary. Dean Hoffmann argued, however, that taking corrective actions is more important than the response itself.

Participants agreed that incorporating and sharing data in one large, accessible repository is important to identify providers that need assistance and/or sanctions. Mr. Connors also commented that the data should be made available to the public. Dr. Hollmann suggested that the database have multiple points of entry so that different entities can access and input information.

Participants reached consensus that the complaint system itself should be regularly evaluated. Dr. Hollmann noted that QIOs attempt to improve the quality of their performance. He cited the need for standards and performance measures so that there can be external validation of the work that is being done. One of the key standards that participants agreed on was timeliness.

Ms. Lock noted that many complaints involve trying to get a person into a particular facility or to get appropriate care, which often requires an immediate decision. Ms. Blackstock felt that it might be unwise to force beneficiaries to make decisions in rigid timeframes that they are not ready to do, while Ms. Paulson commented that timeframes are needed for decision-makers. Participants agreed that the system should examine its own interagency communication mechanisms. They also agreed that the system needs to be able to know how satisfactorily it resolves problems both from a beneficiary perspective and that of state and federal regulators. Everyone agreed that there needs to be meaningful feedback from those who use the system, but the details about how this feedback would be evaluated were not discussed due to a lack of time.

Vicki Gottlich, J.D., L.L.M., attorney with the Center for Medicare Advocacy, asked the group to consider complaints that are related to Medicare Part D. She commented that the Center has heard from many beneficiaries about problems that they have had obtaining their drugs and these complaints are relevant to the discussion.

Participants also considered whether the complaint system might be successful if it were made available to everyone in the country, not just Medicare beneficiaries. Ms. Jimenez and Ms. Hart raised this issue and asked if the system might be a generic feedback process for all patients. It was felt that while this goal would be more costly, it might be worth considering as part of an overall model toward which the group would aspire. It was the sense of the group that this broader approach is less doable in the near term than the development of model standards specific to the Medicare program..

A good portion of the afternoon focused on the potential use of Alternative Dispute Resolution (ADR) within the complaint process. Participants first worked to define ADR. Ms. Lock referred to it as “everything other than litigation,” while Ms. Gottlich described it as a system where both sides come to the table and work to come to consensus. ADR should give equal power to both sides and allow both parties to come away feeling positive about the outcome.

Jackson Williams, a senior policy advisor at AARP’s Public Policy Institute, commented that ADR was a system that was developed to resolve civil disputes where both sides were represented by attorneys. He felt that applying an ADR model to the beneficiary complaint process would pit beneficiaries and their families against doctors and that doctors would have more medical knowledge about the likely outcome of the case, thereby upsetting the balance of power.

Ms. Blackstock informed the group that QIOs currently offer “facilitated resolution,” a form of ADR. It is offered in cases where there are no significant quality of care issues. She noted that this option is the primary approach when the central issue is one of communication. In this forum, she noted, beneficiaries have an opportunity to discuss their perception of what happened and that facilitated resolution has produced systemic changes in some cases. Mr. Connors countered that it would not interest most beneficiaries to engage in ADR once they have been told that their complaint is not significant.

Dr. Hollmann pointed to “Sorry Works” program and health courts as examples of successful mediation. He noted that “Sorry Works” can be a more positive way to approach a problem, even in cases where someone died, allowing for future quality improvement and reducing the “culture of blame.” Ms. Blackstock agreed that mediation allows for more quality improvement opportunities.

Christine A. Bechtel, Vice President of Government Affairs for AHQA, pointed out that beneficiaries are usually very satisfied with mediation. Dr. Berenson commented that medical malpractice health courts can be an expeditious venue to get people compensation and that they provide a robust set of findings and identify errors that would otherwise be missed. He also suggested that these courts allow for the epidemiology of where errors are occurring in the system to locate the individual providers that are problematic.

Other participants felt that ADR might be appropriate in some instances but that it could be a waste of resources that might be better utilized in other areas of the model. In this regard, Dean Hoffmann expressed a concern that it might be difficult to explain to the typical Medicare beneficiary what ADR is and how it would help them. She also thought that many providers might oppose participating because much of ADR is venting by the beneficiary against the provider and the providers would not want to be exposed to such venting.

Mr. Williams proposed that “ADR” or “mediation” might not be appropriate terms for what was being described: a process where there would be no consequences for poor performance or bad behavior but everyone would come away feeling good.

Conference participants were unable to agree on the role of the CMS Medicare ombudsman. As mentioned above, the ombudsman was considered as a possible source for the complaint review process. If it is not the entity responsible for complaint investigation and sanctioning, participants were unsure how the Medicare ombudsman might be involved in the process. Professor Kinney suggested that the ombudsman might help beneficiaries formulate complaints.

Participants also discussed the appropriateness of confidentiality for both providers and patients. Currently, QIOs are protective of provider information as well as any information about the complaint itself that is gathered during the course of an investigation. Ms. Jimenez pointed out that there should be no reason to require a provider’s consent to disclose their name when the beneficiary has already identified the provider. Ms. Blackstock defended the confidentiality policy by saying that the process should encourage full disclosure and not give any reason for a provider not to participate. Ms. Blackstock felt that the current rules on confidentiality prevent any of the information that is gathered in a complaint investigation from being used in court. Ms. Kronmiller, however, informed the group that in Maryland, surveyors’ reports are public documents that can be used in litigation, but that surveyors’ thought processes and notes are not. Ms. Kronmiller stated that this approach allows for public documentation of the findings, but keeps the surveyors out of court, allowing them to continue surveying.

Ms. Edelman pointed out that beneficiaries may want to talk to someone or submit a complaint anonymously because many have a fear of retaliation from the provider. Dr. Hollmann pointed out that this would be feasible for large facilities where chart reviews happen all the time, but at a small practice, it would be difficult for an investigator to preserve anonymity while reviewing the chart. Mr. Schulke suggested that the investigator could conduct a random review of charts, pulling several charts in order to make the process anonymous.

The issue of medical malpractice lawsuits was also raised. Professor Kinney felt that beneficiaries often get unsatisfactory answers from QIOs because QIOs are constrained and do not want to subject the providers to potential litigation. She proposed having medical malpractice cases adjudicated in the Medicare administrative appeals process. This approach would offer Medicare beneficiaries an avenue to seek damages but the process might be more regulated than in regular courts.

Ms. Stein noted that any system that did not include some way to address malpractice issues would be unsuccessful. She felt that providers would not want to enter the process if they thought it would lead to a malpractice case, but, on the other hand, beneficiaries often have a sense of futility and that nothing will happen as a result of their complaints.

Ms. Wells felt that the process should not be tied to the tort system. She did not want to take away a beneficiary’s right to the tort system. From her experience, nursing homes do not listen to the QIOs; they listen to the agency that can sanction them. Ms. Bechtel added that she would not want to see a government-funded litigation system.

The last unresolved issue was budgeting for and the actual implementation of a new complaint process. Ms. Stein reminded the group that the conference was convened to create ideas about what the ideal model should look like. She urged the group not to feel constrained by what might or might not be possible and that such talk would be for later discussion. Ms. Dubow agreed that the model should be “an ideal,” but that she did not want to wait forever. She suggested that proposing new structures is unrealistic and problematic when there is limited funding. Rather, it might be more worthwhile to propose recommendations to fix the problems that exist. Dr. Yessian agreed that more can be done within the current system. Ms. Jimenez agreed with Ms. Stein that it would be best to create a model now and to make compromises from that, not to begin to compromise now.

Participants discussed the amount of money that QIOs are currently given to handle beneficiary complaints. Ms. Bechtel said that it was five percent of the QIO budget or about $15 million per year. She also added that it is not an appropriated amount so the QIOs had to fight with the Office of Management and Budget for the funds. Dr. Boult pointed out that if there is enough political will, there would be a way to find funding and that any changes would require changes to the Medicare statute. Chad Shearer, Legislative Director for Congressman Stark, noted that there might be other ways to pay for the program rather than taking it just from the QIO budget but that some source of funding would have to be found, given the tight budget restrictions in Congress.

Stuart Guterman, Ph.D., Senior Program Director of the Program on Medicare’s Future at the Commonwealth Fund, suggested that this process was not yet at the point where the group needed to be concerned about funding, that there is a problem with how the program is run by the QIOs. He felt that customer service is neglected and that issues of how to repair this function needs to be resolved, including its link to quality improvement. Dr. Guterman urged the group to think more clearly about the elements of the “customer service” function and to whom those functions should be directed.

Mr. Carlson was concerned that the only new initiative would be the proposed “PAL system”. He indicated that any such entity must have some enforcement authority if it is to have leverage with providers. Ms. Stein suggested that the PALs would have ownership over the complaint, and Dr. Yessian added that additional funding would go to SAs, SMBs, and to the creation of a national registry.

Our one day conference provided a remarkably full and productive discussion and preliminary blue print for a Medicare quality review system. The Center for Medicare Advocacy is grateful to the participants for their time and participation, to the Commonwealth Fund for its support, and to the AARP for hosting us. This work will continue as we take the following steps to help move this important quality review discussion forward.

1. Publish this report and conference proceedings in a designated section of the Center for Medicare Advocacy’s website.

2. Prepare a “Beneficiary Quality of Care Complaint Systems” series for the Center’s weekly electronic publication, the “Weekly Alert.” This series will highlight the core elements of the complaint model identified at the Conference and described above. The Center’s “Weekly Alerts” reach a cross-section of the elder rights, health care, and media community, including legislative staff, health policy researchers, Medicare agency staff, academics and researchers, beneficiary advocates, Medicare beneficiaries, and the press.

3. Work with CMS staff to (a) expand its approach to the beneficiary quality of care complaint process to include exploratory models using medical boards and state licensing agencies, at least on a demonstration project bases, to test efficacy and efficiency; and (b) to embrace a set of initiatives to provide more Medicare beneficiary education about the current Medicare beneficiary quality of care complaint process.

4. Work with AHQA pending any movement of the complaint process, to improve their education and outreach efforts toward beneficiaries.

5. Seek funding for a Public Policy legislative “roundtable” targeting Congressional staff to alert members and staff to the issues raised at the conference, highlighting the beneficiary complaint model separate from the functions of the QIO as a viable legislative goal.

[1]The QIO complaint process is mandated by the Medicare statute, 42 U.S.C. § 1320c-3(a)(14). Additional citations and other relevant documents are included in the background papers and other materials that comprise the conference proceedings.