March 14, 2001 Mr. Michael Mangano Acting Inspector General Department of Health & Human Services 330 Independence Avenue, S.W. Washington, D.C. 20201 Dear Mr. Mangano: I am writing on behalf of the members of The American Health Quality Association (AHQA), representing the national network of private Medicare Peer Review Organizations (PROs). AHQA appreciates having the opportunity to comment on your draft report titled, "The Medicare Beneficiary Complaint Process: A Rusty Safety Valve" (OEI-01-00-00060). The OIG has performed a valuable public service in raising the level of debate concerning the Medicare complaint process. In response, AHQA has led the PRO community through active consideration of the criticisms in the draft report, including several meetings with consumer representatives, HCFA officials, and groups of PROs. AHQA recommends a thorough restructuring of the complaint program. We have concluded that HCFA and its PRO contractors can and should do more to make the beneficiary complaint program better known, as well as more responsive to the consumer. While some of the deficiencies in the report can be addressed directly by the PROs, the resources currently invested in this program by the federal government are insufficient to respond to the many challenges noted in your report. AHQA has sent recommendations to HCFA to accomplish reforms identified in your report and by others with whom we discussed your findings. Role of the PROs In Improving Health Quality. The draft OIG report makes some suggestions to remake the PRO beneficiary complaint function into a traditional enforcement program that investigates complaints, fixes blame, and publicly names names. The history of the PRO program suggests there is a better way to use taxpayers' dollars to improve quality. The Medicare beneficiary complaint program was created in the mid-1980s, at a time when the PRO program was built on reviewing thousands of individual patient medical records, looking for quality failures that may require some form of punishment. The notion prevailing at that time was that bad quality results from bad doctors and bad hospitals. Under this approach, when bad actors were found, punishment would be meted out, and the government or its contractors would publicize the names of those found to have failed quality standards. In 1990, the National Academy of Sciences' Institute of Medicine published an extensive study, urging the Medicare program to invest its quality oversight resources more effectively to address the majority of quality shortcomings in our medical care system. By that time, a great deal of evidence had accumulated that quality problems occur in all settings and in all clinical practice settings, and affect vastly larger numbers of people than those treated by "bad doctors" or "bad hospitals." In 1993, clinical quality improvement of the health care commonly provided to older and disabled Americans became the goal of the Medicare PRO program. The PRO program was reshaped to constantly and measurably improve the quality of health care services routinely provided to all Medicare beneficiaries, rather than going after the small number of quality problems resulting from the actions of individual substandard caregivers. HCFA assigned the PROs to serve a new and previously neglected function: clinical quality improvement. Even today, as noted in the draft OIG report, most quality assurance programs are devoted to enforcement of minimum standards. Except for the Medicare PRO and End State Renal Disease (ESRD) Networks (the latter focused on care provided in ESRD facilities), there are still no HHS or State programs with clinical quality improvement as their primary focus. Most Federal and State programs Ñincluding scores of Medicare/Medicaid health facility inspection teams, hundreds of state health professional licensure boards, and innumerable state courts adjudicating malpractice suitsÑ continue to enforce minimum standards of care and impose punishment where bad caregivers are found. OIG identifies numerous shortcomings in the programs and functions that use punitive methods to enforce quality standards, and improvement may well be needed there, but this is not a reason to force the PROs into taking on their role. In fact, many State health professional licensure boards are considering a move to a quality improvement mode of action precisely because they have discovered what HCFA and the PROs discovered in 1993: that case-by-case enforcement of quality standards is a costly and ineffective means of improving the quality of health care provided to consumers. In our comments, we make the point that the beneficiary complaint program has not been updated nor integrated into the PRO quality improvement program established in 1993. We recommend that HCFA reconfigure the program and its funding so that quality improvement Ñincluding follow up by the PRO to help ensure sustained improvementÑ become routine attributes of an up-to-date, more effective PRO complaint program. This change will ensure that consumers can rely on the PRO complaint program to ensure that problems they experienced will not happen to anyone else. Peer Review and Public Disclosure. We agree with the draft report recommendation calling for disclosure of aggregate information on complaints investigated and their resolution. This approach provides information on the types and dispositions of complaints, and ensures public accountability of the PRO program without violating confidentiality protections essential to the peer review process The term "peer review" in the name of Medicare Peer Review Organizations has specific meaning in the Federal law establishing these organizations, and in the usage of this term in State laws governing medical peer review, generally. Peer review is an internal process to secure improved quality by having qualified professionals honestly evaluate and assist one another in improving quality. Peer review committees generally, and the PROs in particular, conduct their work in confidence, without disclosure of their findings. Federal law specifically prohibits disclosure of PRO data and findings. This is an ideal arrangement for conducting the "safe, confidential" quality review advocated by the Institute of Medicine and most investigators of "medical errors" and "patient safety." The peer review approach recruits those who are both most knowledgeable and most able to improve clinical processes Ñdoctors and other health professionalsÑ to help find adverse events and understand their root causes. PROs report that many complainants are not satisfied with this approach, and many prefer to pursue punitive action with public disclosure of the findings of complaint investigations. We believe the PROs should explain to complainants, at the time when a complaint is filed, that the PROs are focused on preventing quality problems from recurring, rather than figuring out who is responsible for what failings and then punishing people for these failings. PROs should ensure that complainants know their choices, so they may choose instead to rely on a licensing board or the courts for punitive action, should they be seeking punishment or need financial compensation for their injuries. Sometimes, the peer review process at PROs and elsewhere discovers an individual who should no longer provide a particular service, or who should no longer practice as a health professional. When these individuals are found, the PROs take action to protect the public, up to and including recommending that such individuals be excluded from the Medicare program. The need for such action is rare. In most cases, the calling of such persons to appear at a formal hearing to consider exclusion from Medicare is sufficient to motivate improvement in those who had previously resisted the PRO's recommendations. Make Complaints a Higher Priority. Complaint investigations should be given a higher priority, with designation as a separate task under the PRO contract to better correspond to the importance of the work. PROs report current funding supports about 2 hours per complaint, but experience indicates about 14 hours are needed (and much more if several care settings are involved in the case, as is common in Medicare+Choice complaints). Increase Outreach. Most consumers are unaware of the PRO complaint process. We concur with the recommendation in the draft OIG report that HCFA request increased resources for outreach in the 7th contract cycle. We believe the PROs and also HCFA itself should conduct education of beneficiaries about this program. Several PROs have reported that both outreach and publicity increase the number of hotline inquiries and complaints submitted for investigation. HCFA should estimate the effect of increased outreach on the volume of complaints. Our discussions with PROs suggest that outreach efforts typically create an immediate local 10-25% increase in hotline and complaint inquiries in communities visited by outreach workers. A wider and more sustained outreach effort will produce a persistent increase in intake and case review volume. Ensure Full Disclosure of PRO Role. Complainants should be informed promptly that the emphasis of the PRO work on their complaint will be quality improvement, rather than assignment and apportionment of blame among the health care providers and practitioners involved in a case. The possibility of sanction in egregious cases should be explained, as well as other aspects of the process to be undertaken by the PRO. If this approach is not what the complainant is seeking, the PRO staff should provide basic information regarding the complainant's other options (e.g., licensure board). Utilize a Case Management Approach. PROs should be funded to place trained case management workers on complaint investigations that are formally opened. PROs indicate this, along with full early disclosure of the process they use, improves beneficiary satisfaction with the process. The key to this approach is to assign cases to individual PRO employees (generally RNs), who then stay in contact with the complainant and manage follow up action on the complaint. PROs using this method report a manageable workload is about 20-25 cases per RN at any given time, and estimate an increase in costs of 50-100% over a traditional complaint process. In addition, some PROs have had great success using social workers to interview complainants (who frequently include angry family members). AHQA is willing to coordinate with HCFA to provide a forum during our annual Technical Conference for appropriate training and process improvement by PRO caseworkers. Expand Fact Finding. The draft OIG report cites the rarity of PROs pulling additional medical records when they are investigating complaints, to see if quality problems involving a provider or practitioner are more widespread than the original case, and to look for root causes of a problem. OIG notes that the legal authority to obtain and review these charts is already in place. AHQA agrees with this recommendation, but it is important to provide the resources to examine additional records. At present, PROs have the authority, but not the budget, needed to pull additional charts, analyze them, and include them in the extensive security systems PROs have in place. One of the early lessons learned by congressional investigators in the 1980s is that funding does not automatically follow new work assigned to the PROs by HCFA or by Congress. Create a Mediation Option. AHQA disagrees with the draft report's assertion that mediation is not ready for implementation. Mediation is a powerful tool to address complaints when the consumers have not been fully informed, or have misunderstood important information. Consumers typically leave mediation knowing that their concerns were heard. In PRO pilot projects, consumer complainants demonstrated a strong interest in mediation, but practitioners were unfamiliar with the new process and reluctant to join mediation. However, in the pilot projects, little time and energy could be devoted to outreach to the providers and practitioners to explain the mediation option. AHQA recommends HCFA establish a mediation option under the complaint program, with significant and ongoing outreach to provider and practitioner organizations to increase its use. Follow up Findings with Quality Improvement. Follow up of validated complaints is essential. The current program is constrained by resources and by a limited range of options for follow-up action. AHQA recommends the beneficiary complaint process include quality improvement interventions when the PRO identifies opportunities for improvement. At present, when a complaint is validated, PROs send an "educational letter" to practitioners, indicating areas in which improvement is needed. PROs also have the option of directing a specific corrective action, and, in egregious cases, they may pursue sanctions to exclude an individual from Medicare. However, educational letters are seldom followed up, and most validated complaints do not involve quality problems warranting directed correction or sanction. Working in a more focused and sustained way with providers and practitioners enhances follow up, helps ensure changes in practice are sustained, and gives PROs a means of meaningfully addressing a larger proportion of complaints. HCFA should also fund local quality improvement projects to address problems PROs find in the course of complaint work. Analyze Complaint Data. Complaints should be categorized and analyzed for patterns, at the state and national level. Solutions found for common problems should be shared with other PROs, in a manner similar to bulletins sent to providers by the Institute for Safe Medication Practices. HCFA needs new resources to create a national database, built from the ground up with the participation of experienced individuals working on beneficiary complaints at the PROs. Thank you for your willingness to receive suggestions from the PRO community. Cordially, David G. Schulke Executive Vice President