MEMORANDUM & ORDER

Jack B. Weinstein, Senior United States District Judge.

In October 2015, this court stayed class certification in the above-captioned cases and referred the critical issue of an appropriate definition of " flushable" wipes and related matters to the Federal Trade Commission (" FTC" ). See Belfiore v. Procter & Gamble Co., 311 F.R.D. 29 (E.D.N.Y. 2015), reconsideration denied, 140 F.Supp.3d 241 (E.D.N.Y. 2015); Order Staying Cases 14-CV-1142, 15-CV-2909, 15-CV-2910, 15-CV-2928, and 15-CV-4579, Oct. 9, 2015.

Motions to reconsider and lift the stay were denied in order to provide the FTC with time to reach, in its discretion, a national " flushable" wipes definition applicable to manufacturers and retailers--and protective of consumers nationwide. See Belfiore v. Procter & Gamble Co., 140 F.Supp.3d 241, 246 (E.D.N.Y. 2015) (" Referral to the FTC in the present case is appropriate. The FTC is specifically granted broad power to regulate advertising and should be afforded the opportunity to determine a uniform definition of 'flushable' applicable on a national, and perhaps international, basis" ); Kurtz v. Kimberly-Clark Corp., No. 14-CV-1142, 2015 WL 8481833, at *3-4 (E.D.N.Y. Dec. 10, 2015). It was noted that " allowing the FTC to develop a common definition of 'flushable' reduces the substantial risk of inconsistent judgments and facilitates the prospect of an injunctive class settlement, aiding manufacturers, retailers, and the public." Belfiore, 140 F.Supp.3d at 246; see also Belfiore, 311 F.R.D. at 78-79.

The cases before us are individual consumer cases. There is a larger issue of possible liability to, and protection of, waste disposal plant operations by municipalities and others, not before this court. See, e.g., City of Perry, Iowa v. Procter & Gamble Co., et al., __ F.Supp.3d __, 2016 WL 2939511 (S.D.N.Y. May 19, 2016).

At the time of this court's December 10, 2015 memorandum and order in the case of Kurtz v. Kimberly-Clark Corp., the FTC had entered into a final consent decree with Nice-Pak Products, Inc. (" Nice-Pak" ), concerning its " flushable" wipe product. See Kurtz, 2015 WL 8481833 at *4. The agency was apparently continuing to investigate additional manufacturers of " flushable" wipes, including two of the defendants in actions currently before this court. See id.

On June 10, 2016, the Administrative Conference of the United States adopted a recommendation providing guidance to administrative agencies " on the use of aggregation techniques to resolve similar claims in adjudications." See Aggregation of Similar Claims in Agency Adjudication, 81 Fed.Reg. 119, 40259-61 (June 21, 2016) (attached to this order). It recognized " aggregation as a useful tool to be employed in appropriate circumstances." Id. at 40260. Although the recommendation is non-binding, the Administrative Conference recognized a federal agency's broad discretion to aggregate cases:

The Administrative Procedure Act (APA) does not provide specifically for aggregation in the context of adjudication, though it also does not foreclose the use of aggregation procedures. Federal agencies often enjoy broad discretion, pursuant to their organic statutes, to craft procedures they deem " necessary and appropriate" to adjudicate the cases and claims that come before them. This broad discretion includes the ability to aggregate common cases, both formally and informally.

Id. (footnotes omitted).

The newly adopted recommendation presents an important route that will be carefully considered by administrative and other agencies, as well as by the Bench, the Bar, and academia, in connection with mass actions that should be aggregated. See Michael Sant'Ambrogio & Adam Zimmerman, Inside the Agency Class Action (June 15, 2016) (unpublished manuscript) (on file with the court and attached to this order) (analyzing the use of aggregate procedures in administrative agencies as well as the challenges and benefits of aggregate agency adjudication); see also Michael Sant'Ambrogio & Adam Zimmerman, Administrative Conference of the United States, Aggregate Agency Adjudication (June 9, 2016), available at https://www.acus.gov/report/aggregate-agency-adjudication-final-report.

The captioned cases may be particularly appropriate for aggregate agency resolution. The parties are encouraged to explore the opportunity for aggregate adjudication of their claims before the FTC pursuant to the new federal recommendation by the Administrative Conference of the United States.

SO ORDERED.

Abstract

Federal agencies in the United States adjudicate hundreds of thousands of cases each year. Yet even with this high volume of cases, agencies have not widely deployed tools used in federal court to efficiently resolve large groups of claims, such as class actions and other complex litigation procedures.

A handful of federal administrative programs, however, have quietly bucked this trend--employing class action rules, collective claim handling, and even the kinds of " trials by statistics" once embraced by federal judges around the United States. The Equal Employment Opportunity Commission, for example, created an administrative class action procedure, modeled after Rule 23 of the Federal Rules of Civil Procedure, to resolve " pattern and practice" claims of discrimination by federal employees before administrative judges. Since the early 1990s, the National Vaccine Injury Compensation Program has used " Omnibus Proceedings," which resemble federal multidistrict litigation, to pool together common claims that allege a vaccine injured large groups of children. And facing a backlog of hundreds of thousands of claims, recently the Office of Medicare Hearings and Appeals announced a new " Statistical Sampling Initiative" --a pilot program that will use trained and experienced experts to resolve hundreds of common medical claims at a time by statistically extrapolating the results of a few hearing outcomes.

These efforts to employ the tools of aggregation in administrative proceedings have received little examination. Consequently, very little is known about: (1) how agencies choose cases or claims appropriate for aggregation, (2) which aggregation tools these agencies use, (3) the successes and failures of these programs, and (4) the other types of proceedings in which different aggregation tools might facilitate more expeditious, consistent, and fair handling of large groups of claims.

Based on our examination of recent efforts by federal agencies to aggregate administrative proceedings and dozens of interviews with the key policymakers involved, we identify the types of agency adjudications in which aggregate procedures have the greatest potential, the challenges and obstacles to greater use of aggregation, and broader lessons about what aggregation procedures mean for adjudications conducted by federal agencies.

Table of Contents

Introduction
I. Aggregation in Judicial and AdministrativeProceedings
A. The Costs and Benefits of Aggregate Adjudicationin Court
B. The Legal Framework for Aggregation in AgencyAdjudications
II. Aggregate Agency Adjudication
A. The Equal Employment Opportunity Commission (EEOC)
1. EEOC Class Actions in Administrative Proceedings
2. EEOC Class Action Procedures: Similarities andDifferences from
Federal Rules
3. Values Served by EEOC Class Actions
4. Challenges of EEOC Class Actions
B. The National Vaccine Injury Compensation Program(NVICP)
1. The Origins of the Omnibus Proceeding
2. Challenges of Omnibus Proceedings
C. Office of Medicare Hearings and Appeals (OMHA)
1. The Backlog in OMHA Appeals
2. OMHA's Power to Aggregate Appeals
3. OMHA's Statistical Sampling Initiative
4. OMHA's Settlement Conference FacilitationInitiative
D. Challenges and Benefits of Aggregate AgencyAdjudication
1. Aggregate Adjudication Can Pool Information, ReachConsistent
and Efficient Outcomes, and Improve Legal Access
2. Addressing Concerns of Efficiency, Legitimacy, andAccuracy
Aggregate Agency Adjudication
III. The Forms and Limits of Adjudication
A. Agencies Themselves Constitute a Form ofAggregation
B. The Law's Resistance to Aggregation inAdjudication
C. The Resistance of Policymakers to EnablingLitigation
Conclusion

INTRODUCTION

A crisis is brewing in Medicare. In 2003, Congress created the Office of Medicare Hearings and Appeals (OMHA)--a specialized administrative court designed to resolve billing disputes between the federal government and hospitals, nursing homes, medical equipment providers, and others. But after six years of relative normalcy, case filings at OMHA began to spiral out of control. By 2014, OMHA's backlog had spiked to almost 500,000 cases. Worse yet, average wait times for benefit decisions mushroomed to over 600 days in 2015. Even though OMHA is required to make such decisions, by law, in 90 days, its workload became so heavy that at one point it took almost five to six months just to enter new cases onto its docket.

Medicare's problems are hardly unique in the administrative state. The number of claims languishing on administrative dockets and in other specialized courts has become a new crisis -- producing significant backlogs, arbitrary outcomes and new barriers to justice. Last week, the Department of Education acknowledged that over 20,000 students with similar claims for loan forgiveness currently sit on growing waitlists with the agency, a year after the for-profit Corinthian Colleges collapsed under the weight of several state and federal fraud investigations. The Department of Veteran's Affairs recently admitted that veterans face average wait times of four years to obtain their disability benefits. Even as Congress tries to create similar administrative programs to resolve claims more quickly than the federal courts, they often meet the same Kafkaesque fate.

But what made OMHA unique was its response. Last year, OMHA announced that it would adopt a fascinating new pilot program that allows medical providers with large numbers of similar claims to conduct " trials by statistics." Dubbed the " Statistical Sampling Initiative," a medical provider with more than 250 similar claims would have the option to try a small sampling of those claims before an administrative law judge and extrapolate the average result to the rest. To do so, a hospital, doctor or other medical provider would meet with one of Medicare's " trained and experienced statistical expert[s]" to develop the " appropriate sampling methodology" and randomly select the sample cases to be extrapolated to the whole. Following a pre-hearing conference, all of the pending claims would be consolidated in front of a single Administrative Law Judge to hear all of the sample cases selected by the OMHA statistical expert. The results of the sample cases would then be applied to all of the remaining cases.

Although OMHA's Statistical Sampling Initiative is just in its initial stages, it is notable for two reasons. First, it diverges from the Supreme Court's approach in the federal courts, which appeared to reject such " trials by formula." The Supreme Court has worried that the " novel" use of statistical sampling could stretch hearing procedures too far under the Rules Enabling Act by " abridging, enlarging or modifying" the substantive rights of the parties in such a mass action. To the extent this remains a problem for federal courts, the decision does not bind federal agencies. Federal agencies often enjoy more discretion under their own statutes to craft procedures they deem " necessary and appropriate" to adjudicate the claims that come before them. OMHA's program thus illustrates agencies' comparative freedom over federal courts to create innovative procedures that respond to problems in mass adjudication.

Second, it is very rare that agencies exercise this freedom. Federal agencies and specialized courts in the United States adjudicate hundreds of thousands more cases each year than our federal court system. But they have long avoided tools used by courts to efficiently resolve large groups of claims, like class actions and other complex litigation procedures. Unlike federal courts--where almost 40 percent of all cases now proceed in some form of organized litigation --most agencies and specialized courts do not use class actions or otherwise coordinate multiparty disputes. Consequently, in a wide variety of cases, such programs risk wasting resources in repetitive adjudication, reaching inconsistent outcomes for the same kinds of claims, and denying individuals access to the affordable representation that aggregate procedures promise.

Part of the reason for agencies' restrained, individualized approach to adjudication stems from the perceived limits of what courts and administrative judges can do to resolve claims brought by large groups of people. For years, the Supreme Court and scholars have said that legislative bodies--not judges--should respond to problems of mass harm. Policymakers can resolve cases raising the same complicated factual and legal issues more legitimately and efficiently by relying on a legislative process to establish uniform criteria. Judges, by contrast, should avoid such " poly-centeric disputes" because they lack the capacity to hear and resolve such claims among large groups of people. Indeed, commentators have criticized aggregate settlements as " privatized administrative schemes" designed to compensate victims like " public administrative agencies."

That same line between the appropriate role of courts and legislative bodies also exists inside administrative agencies. Before the Administrative Procedure Act (APA), agencies combined investigation, policymaking, and adjudication in the same department. Following a political battle over the implementation of New Deal programs, the APA separated the practice of " adjudication" from the agencies' broad policymaking powers using rulemaking and enforcement, establishing distinct rules for each type of agency activity. Going forward, formal individualized adjudications would be conducted by independent administrative law judges (ALJs) insulated from undue political influence. Few rules existed in the APA, however, for ALJs to resolve cases that fell in between the formal categories of rulemaking and adjudication--such as when adjudicative proceedings systematically affected groups of people in the same way.

A handful of federal administrative programs, however, have quietly bucked this trend--employing class action rules, collective claims handling and even the kinds of " trials by statistics" embraced by innovative federal judges around the United States. The Equal Employment Opportunity Commission (EEOC), for example, created an administrative class action procedure, modeled after Rule 23 of the Federal Rules of Civil Procedure, to resolve " pattern and practice" claims of discrimination by federal employees before federal administrative judges (AJs). Since the early 1990s, the National Vaccine Injury Compensation Program (NVICP) has used " Omnibus Proceedings," which resemble federal multidistrict litigation, to pool together common claims that allege a vaccine injured large groups of children. And, as discussed above, the Office of Medicare Hearings and Appeals (OMHA) recently began two pilot programs utilizing aggregation tools: (1) a " Statistical Sampling Initiative" that will use trained and experienced experts to resolve thousands of common medical claims at a time by statistically extrapolating the results of a few hearing outcomes; and (2) a Settlement Conference Facilitation program that provides a formal framework for encouraging the settlement of large numbers of similar cases.

Although commentators and courts frequently hold up public administrative schemes as an efficient alternative to group litigation in court, each of these efforts suggest agencies sometimes cannot avoid using the same aggregation procedures themselves. Indeed, such efforts appear to be on the rise. In January 2016, plaintiffs petitioned the Federal Maritime Commission to hear a multi-million dollar antitrust class action after the federal government fined several companies for violating the Shipping Act of 1984. A week later, the federal government conceded for the first time that a specialized-veteran court could hear class action claims by veterans in " appropriate cases." And in June 2016, the Department of Education proposed a new " group process" loosely modeled on federal class action rules to make it easier for students to obtain loan forgiveness when they attend predatory colleges that commit fraud. All of these examples suggest that simply moving groups of similar cases out of courts and into administrative programs cannot fix problems inherent in case-by-case adjudication. Agencies and specialized courts themselves also may require aggregate procedures to overcome long backlogs, inconsistent results, and obstacles to justice for those without access to legal and technical expertise.

To date, no study has examined these nascent efforts to employ the tools of aggregation in administrative proceedings. Indeed, there has been little attention to how agencies may draw upon the lessons of the federal courts in adjudicating claims by large groups of people. Consequently, very little is known about: (1) which cases are appropriate for aggregation, (2) which aggregation tools these agencies use, (3) the successes and failures of these programs, and (4) the other types of proceedings in which aggregation tools might facilitate more expeditious and fair handling of large groups of claims.

Our project begins to fill this gap by taking a look inside some of the few agencies that experiment with aggregate adjudication. After examining recent efforts by federal agencies to aggregate administrative proceedings and interviewing the key policymakers involved, we identify the types of agency adjudications in which aggregate procedures have the greatest potential, the challenges and obstacles to greater use of aggregation, and broader lessons about what aggregation procedures mean for adjudication by federal agencies.

This Article proceeds in three parts. Part I sets out the legal framework for adopting aggregate litigation procedures in federal courts and administrative agencies. Federal courts have long enjoyed authority to aggregate large groups of similar cases in one of two ways. First, courts may formally aggregate claims by, for example, permitting one party to represent many others in a single lawsuit. Second, courts may informally aggregate claims. In informal aggregation, different claimants with very similar claims each retain separate counsel and advance a separate lawsuit, but in front of the same adjudicator or on the same docket in an effort to expedite cases, conserve resources, and assure consistent outcomes. Agencies similarly enjoy broad authority to aggregate common cases, formally and informally.

Part II describes different approaches to formal and informal aggregate adjudication with a focus on three federal programs--EEOC's use of class actions, the NVICP's use of " omnibus proceedings," which centralize many individual cases raising similar claims before the same adjudicator, and OMHA's use of consolidation, statistical sampling, and mediation to resolve thousands of similar cases in the same proceeding. Those case studies illustrate that aggregate adjudication techniques raise unique challenges. The sheer number of claims in aggregate agency adjudication may: (1) create " diseconomies of scale" --inviting even more claims that stretch adjudicators' capacity to administer justice to many people; (2) impact the perceived " legitimacy" of the process and challenge due process; and (3) increase the consequence of error. In other words, just like many kinds of administrative systems, aggregate adjudication struggles to deal with many different kinds of constituencies feasibly, legitimately, and accurately.

But, as we detail below, each program has sought to ameliorate these concerns by adopting aggregate procedures cautiously and responsibly. Among other things, they have responded to challenges of aggregation by (1) slowly rolling out aggregate procedures to avoid replacing old backlogs with new ones; (2) relying on panels of adjudicators to reduce allegations of bias or illegitimacy or providing additional opportunities for individuals to meaningfully participate in the process; and (3) allowing cases raising scientific and novel factual questions to " mature" --that is, putting off aggregation until the agency has the benefit of several opinions and conclusions from different adjudicators about how a case may be handled expeditiously. As a result, aggregate adjudication has permitted agencies to take advantage of the benefits of aggregation--pooling information about recurring problems, achieving greater equality in outcomes than individual litigation, and securing expert assistance at a critical stage in its own decisionmaking process--while minimizing their potential dangers.

Part III considers the broader implications for adjudication by federal courts and agencies. Courts and commentators frequently view administrative programs as more legitimate than aggregation in federal or state court. However, those same agency adjudicators face their own legitimacy crisis when they cannot aggregate and actively manage cases themselves. Rather than building formal walls between policymaking and court-procedures to avoid illegitimate decisionmaking, in some cases, we must do the opposite--allow adjudicators to integrate rulemaking and other managerial tools into their proceedings to promote " the presentation of proofs and reasoned argument."

I. Aggregation in Judicial and Administrative Proceedings

Civil and administrative proceedings begin with the premise that every person deserves her or his own " day in court." Plaintiffs in civil court receive personalized hearings to sort out private disputes with others. Agencies similarly must provide citizens with " some kind of hearing" to challenge government acts that threaten their lives, property, or liberty.

Both systems, however, have exceptions--grouping together and resolving large groups of similar claims, or what we call " aggregation." In some ways, a central tenet of all legal systems is to aggregate. Policymakers and judges create and interpret substantive rules to account for recurring problems and treat " like cases in a like manner." It is the reason why common law judges must consider the precedential impact of their decisions on similar cases and why legislators create agencies with specific missions to create rules for, and adjudicate, particular kinds of cases. One theory posits that administrative agencies represent a public counterpart to class action lawsuits--another form of aggregation--because Congress delegates them authority to pursue ends that benefit broadly defined interest groups against those who violate the law.

But federal courts use other procedures to group together large numbers of cases. As noted above, the most famous kind of " aggregate lawsuit" is the class action--a single lawsuit that includes claims or defenses held by many different people. Other kinds of formal aggregations include derivative lawsuits by a shareholder on behalf of a corporate organization, lawsuits by and against organizations in bankruptcy, trustee actions commenced on behalf of many beneficiaries, and parens patriae actions by state attorneys general. What all formal aggregations have in common is that a single person, or a single proceeding, may bind others to the outcome, even if those others never directly participate.

Courts also group together civil claims in far more informal ways. Courts frequently " informally aggregate" cases--channeling individually represented parties into the same courthouse, before the same judge, or onto a specialized docket. In civil litigation, the most well-known form of administrative aggregation is the multidistrict litigation, where a panel of judges may assign a large number of similar claims filed around the country to the same judge to streamline discovery, manage motion practice, coordinate counsel and, in many cases, expedite settlement. Since its creation in 1968, the Judicial Panel on Multidistrict Litigation has centralized almost half a million civil actions for pretrial proceedings. Other forms of administrative aggregation in civil law include specialized dockets--like those designed to expedite patent claims filed in the Eastern Districts of Virginia and Texas --or inter-district rules designed to ensure that a single judge hears all " related claims" in the same district.

A. The Costs and Benefits of Aggregate Adjudication in Court

Aggregate procedures in federal court seek to provide more access, efficiency, and consistency than individualized litigation. Aggregate litigation in federal and state courts has long sought to provide more legal access by enabling the resolution of claims that otherwise would not be brought individually. Formal aggregate procedures are thought to enable litigation when damages are too small for individuals to justify the high costs of retaining counsel. Informal aggregation also streamlines large-scale litigation, while encouraging parties to participate, through bellwether trials, steering committees of plaintiff that collect and manage claimant input, and judicial oversight of attorney conduct. In both cases, large cases hold defendants accountable for wide and diffuse harms that are too costly to be prosecuted through individual litigation.

Aggregate procedures also seek more efficient resolutions than piecemeal individual adjudication. Aggregation hopes to avoid the duplicative expenditure of time and money associated with traditional one-on-one adjudications, which otherwise may involve months or years of the " same witnesses, exhibits and issues from trial to trial."

Finally, aggregate procedures seek more uniform application of law. At bottom, aggregate proceedings and settlements seek consistency and distributive fairness--to treat like parties in a like manner. Otherwise, in cases seeking injunctions or declaratory relief, a court may never hear from plaintiffs with competing interests in the final outcome, or over time, subject defendants to impossibly conflicting demands. And, in cases seeking monetary relief, the first claimants to bring lawsuits might receive astronomical awards, while other victims receive nothing.

But large cases also create new risks. Class actions require judicial review, for example, to ensure class counsel faithfully represent absent class members, to provide a forum to hear from dissenting interest groups, and to ensure that the final settlement adequately reflects the underlying merits and the public interest. Thus, even as they aspire to promote more efficiency, consistency, and legal access, class action lawsuits struggle to (1) promote efficiency when processing large volumes of cases; (2) ensure legitimacy when clients lack input and control over the outcome and when attorneys serve disparate interests (or their own); and (3) achieve accuracy when group-wide outcomes or settlements blur characteristics or overlook the merits of many different kinds of cases.

Informally aggregated cases may also complicate legitimacy and accuracy. First, lawyers experience conflicts when they settle individual cases in informal aggregations, particularly because the success of any one case often depends on the same lawyer or judge resolving hundreds of similar claims. Informally aggregated civil cases may also compromise individual parties' control over the outcome, as a small number of lawyers, special masters, or magistrates, make decisions about common questions of discovery, motion practice, or other " common benefit work." According to the American Law Institute's Principles of Aggregate Litigation, informal aggregations " afford participants some important powers, but deny them others" :

For example, they continue to be represented by their own attorneys, and they can accept settlement offers or reject them. But, in important respects they are also at the mercy of others. They cannot escape aggregation, even when it occurs against their wishes, and ... they must accept services from and pay fees to lawyers and other persons they have little power to control.

Second, informal aggregation can compromise accuracy--particularly when the same plaintiff and defense counsel settle large groups of cases in bulk. This is sometimes a result of perverse incentives created by the ways parties must organize themselves to process large volumes of claims. For example, plaintiffs and defendants have complained that multidistrict litigation favors volume over knowledge: attorneys often receive coveted and lucrative positions on steering committees based on the sheer number of clients they retain in the litigation. Those incentives may, in turn, delay and discourage lawyers from investing limited resources to develop the facts of individual cases before reaching a global settlement.

In other words, like many kinds of bureaucratic systems, formal and informal aggregate litigation struggles to govern many different kinds of constituencies feasibly, legitimately, and accurately. As set forth below, agencies also enjoy power to formally and informally aggregate claims. When they have exercised this power, they have sought to adopt tools that take advantage of the benefits of aggregation while minimizing the potential dangers.

B. The Legal Framework for Aggregation in Agency Adjudications

Congress regularly creates administrative courts in which the adjudicators do not enjoy the life tenure and salary protections provided to federal judges by Article III of the Constitution. When Congress vests adjudicatory power in such " non-Article III courts," it usually employs one of its enumerated powers in Article I, in combination with the Necessary and Proper Clause. Such non-Article III courts include both administrative agencies that adjudicate cases and what are sometimes called " Article I" or " legislative courts."

When Congress creates non-Article III courts, it both defines their jurisdiction and typically grants them substantial discretion to prescribe rules of practice and procedure to carry out their statutory mandates. For example, in CFTC v. Schor, the Supreme Court rejected the lower court's conclusion that the Commodity Futures Trading Commission (CFTC) lacked the power to join counterclaims. The Supreme Court based its holding, in part, on the " the sweeping authority Congress delegated to the CFTC." In particular, the Supreme Court relied on statutory language that permits the CFTC to " make and promulgate such rules and regulations as, in the judgment of the Commission, are reasonably necessary" to accomplish the purposes of the statute authorizing its existence.

Where an agency's organic statute does not set forth any specific procedural requirements, the Administrative Procedure Act (APA) provides certain minimum procedural requirements for different types of agency action. But the Supreme Court has repeatedly prohibited courts from imposing additional procedural requirements on agencies, reasoning that agencies " should be free to fashion their own rules of procedure and to pursue methods of inquiry capable of permitting them to discharge their multitudinous duties."

For this reason, in FCC v. Pottsville, the Supreme Court rejected a challenge to the FCC's authority to consolidate three licensing applications for the same facility in a single hearing so as to consider the applications " on a comparative basis." The Court held that when Congress gave the Commission authority to grant, modify, or revoke broadcast licenses as " public convenience, interest, or necessity" require:

the subordinate questions of procedure in ascertaining the public interest, when the Commission's licensing authority is invoked--the scope of the inquiry, whether applications should be heard contemporaneously or successively, whether parties should be allowed to intervene in one another's proceedings, and similar questions--were explicitly and by implication left to the Commission's own devising.

Accordingly, the Court recognized that the Commission possessed this discretion regardless of whether it chose to promulgate a rule of procedure or created an ad hoc rule tailored to a specific case.

Similarly, there is nothing in the APA that would prevent an agency from using aggregation in adjudicatory proceedings in appropriate cases. Indeed, prohibiting aggregation mechanisms under the APA would be at odds with the substantial flexibility the Supreme Court has granted agencies when choosing the best procedural format for decisions that affect large groups of people.

In some ways, federal agencies enjoy more power to develop procedural rules than Article III courts. The Rules Enabling Act states that Article III courts may only " prescribe general rules of practice and procedure" that do not " abridge, enlarge or modify any substantive right." By contrast, administrative agencies generally have no such limitation because Congress creates most administrative agencies precisely because Congress wants them to make substantive law. Even legislative courts that most closely resemble the Article III courts generally are not subject to the same restrictions under the Rules Enabling Act.

The recognition by federal courts that Congress generally vests administrative agencies with considerable procedural flexibility reflects a basic feature of administrative law: agencies must have the authority to shape their own rules and, when appropriate, to adapt those rules to the types of cases and claims that they hear. This means that absent an express statutory prohibition or other clear indication of congressional intent to the contrary, administrative agencies may use aggregate procedures to handle their cases more expeditiously, consistently, and fairly than would be possible with individual, case-by-case adjudication.

II. Aggregate Agency Adjudication

As we note above, most agencies have resisted using class actions and other complex procedures like federal courts. But agencies not only have power, but, on rare occasions, have used that power to aggregate claims formally and informally. Relying on general grants of authority to adopt their own procedures, we have identified more than forty administrative agencies and other non-Article III courts that have promulgated rules permitting the consolidation of cases to hear claims. The complete list is included in Appendix A. Some of these non-Article III tribunals have promulgated formal class actions rules. Examples include the Bankruptcy Courts, EEOC, the Consumer Product Safety Commission (CPSC), and the Personnel Appeals Board.

The EEOC's experience, discussed more fully below in Section II.A., is illustrative. Congress vested the EEOC with the power to hear discrimination claims brought by federal employees and " to issue such rules, regulations, orders and instructions as it deems necessary and appropriate to carry out its responsibilities under this section." Relying on that language, in 1992, the EEOC adopted a class action procedure.

In 2004, the Postal Service challenged EEOC's class action rule. The Office of Legal Counsel (OLC) for the Department of Justice (DOJ) rejected that challenge and confirmed the EEOC's broad authority to use class actions to aggregate claims. Observing that class actions were " procedural in nature," the OLC concluded that the EEOC could properly adopt class action rules under its congressional directive to issue " such rules . . . as it deems necessary and appropriate to carry out its responsibilities."

In addition, like Article III courts, which aggregate with different levels of formality, many Article I courts and administrative agencies also aggregate claims and cases without adopting a formal procedure to do so. For example, the Office of Special Masters (OSM) in the NVICP has not promulgated a rule on aggregation. But, for some two decades, the OSM has relied instead on its general authority to " determine the format for taking evidence [and] . . . hearing argument[,]" and to " apply [its] expertise" from one case to another. Thus, as discussed more fully below in Section II.B, when faced with large numbers of claims for compensation, the OSM developed " omnibus proceedings" to more efficiently process claims involving the same alleged vaccine-related injury. In an " omnibus proceeding," a single special master hears evidence and makes a decision on a theory of general causation--for example, whether a vaccine can cause chronic arthritis and, if so, under what circumstances. The " general causation" evidence is then available for application in individual cases.

In addition to the techniques described above, some agencies have used their formal power to consolidate enforcement actions against large groups of defendants to efficiently dispose of common claims. In other cases, administrative agencies have coordinated enforcement actions for settlement. For example, the EPA often enters what some call " industry-wide" settlements, brokering coordinated individual deals as part of a systemic response to an ongoing policy or problem. In one well-known case, the EPA in 2005 offered qualified animal feeding operations (AFOs)--over 2,500 agribusinesses that produce pork, dairy, turkey and eggs across the country--to enter into a global settlement to resolve their liability under the Clean Water Act. Much like a private aggregation, each individual AFO would enter into a separate, but otherwise identical, agreement with the EPA. Each AFO would agree to pay a civil fine (categorically based only on the size of the AFO) to fund a nationwide study on monitoring AFO emissions and, if requested, help the EPA to monitor emissions from the AFO. In return, the EPA agreed not to sue the participating AFOs for past and ongoing violations while the study was undertaken.

Agencies also may employ many different forms of informal aggregation to streamline certain categories of claims. The Executive Office for Immigration Review--which hears all cases involving detained aliens, criminal aliens, and aliens seeking asylum--offers one example of this kind of informal aggregation. In the past year, it has created special " surge courts" to respond to over 2,000 Central American asylum cases pending in West Texas.

Although we do not address all of these forms of aggregation, the three case studies below illustrate a range of aggregate techniques used to resolve large groups of cases in administrative programs, the challenges each has faced, and potential lessons for the future.

A. The Equal Employment Opportunity Commission (EEOC)

The EEOC is the nation's lead government enforcer of federal civil rights laws prohibiting discrimination in employment based on race, color, sex, religion, national origin, age, disability, and genetic information, as well as reprisal for protected activity. The EEOC's specific role and responsibilities depend on the nature of the employer involved. In the case of private employers, the EEOC has authority to file a lawsuit in federal court to protect the rights of individuals and the interests of the public. Alternatively, if the EEOC finds there is no discrimination or finds there is discrimination, is unable to settle the charge, and decides not to file a lawsuit, the EEOC will issue the employee a Notice of Right to Sue, which allows the complainant to sue the private employer in federal court. In the case of state and local employers, the EEOC refers the matter to DOJ, which has authority to file a lawsuit in federal court.

The process is somewhat different for federal government employees. Federal employees must first file a complaint with the EEO Office of their federal employer. When the agency's investigation is completed, the employee may then either ask for a final decision from the agency or request a hearing before an EEOC AJ.

More than 100 AJs work in EEOC regional offices around the country in order to adjudicate disputes between federal employees and their federal employers. After conducting an evidentiary hearing on the record, the AJ issues a decision and may order appropriate relief. Once the AJ hands down a decision, the agency has 40 days to issue a final order, which either accepts or rejects the decision of the AJ. If the agency does not accept the decision or disagrees with any part of the decision, the agency may file an appeal with the EEOC's Office of Federal Operations. Similarly, an employee who is unhappy with an agency's final order may appeal the order to the Office of Federal Operations.

Although federal employees must generally go through the administrative complaint process, there are several different points during the process at which the employee may quit the process and file a lawsuit in federal court, including after the agency's decision on the employee's complaint, so long as no appeal has been filed with the EEOC, and after the EEOC's decision on an employee's appeal from a final order.

1. EEOC Class Actions in Administrative Proceedings

The EEOC's regulations grant EEOC AJs the power to certify and hear class actions against federal employers in administrative proceedings. Even though Congress never explicitly conferred power on the EEOC to create a class action rule, the EEOC has long asserted authority to create a class action procedure based on its jurisdiction to hear discrimination claims against federal employers. As noted above, the Office of Legal Counsel accepted the EEOC's argument, finding the EEOC's decision to create the procedure was entitled to Chevron deference.

The EEOC's use of class action procedures--which are loosely modeled after Rule 23 of the Federal Rules of Civil Procedure--makes the EEOC something of an outlier in our federal administrative state. Some agencies are specifically empowered to hear class actions in cases involving workplace disputes--like the Merit Systems Protections Board and the Personnel Appeals Board--where employees claim a government employer's " pattern and practice" violates their rights. And a number of other agencies have promulgated rules permitting the certification of class actions in their administrative proceedings, but they almost never use the power. For example, the Board of Governors of the Federal Reserve System and the Consumer Financial Protection Bureau both theoretically may pursue class actions in their own administrative proceedings against financial businesses that violate the Equal Credit Opportunity Act, but according to our correspondence with both agencies, neither has invoked that authority.

Three other agencies have formally considered, and rejected, class action procedures, reasoning that they lack the capacity, authority, or good reason to do so. First, just last year, the Federal Communications Commission (FCC) considered and then rejected a proposal to hear class actions in its own adjudications for alleged violations of the Federal Communications Act. Among other things, the FCC worried that the procedure would " needlessly divert" the resources of its lone ALJ to adjudicating extremely " fact-intensive and complex" cases, that can just as easily be filed in federal court. The FCC also believed that it could more efficiently complement federal court class action practice by resolving any outstanding legal questions referred to the FCC by invoking the doctrine of an agency's " primary jurisdiction" to settle a contested interpretation of federal statutes or regulations.

Second, the CFTC similarly considered and rejected the use of class actions for its own adjudication process involving broker-dealer disputes. It likewise questioned whether its adjudicators could handle complex class action cases, as well as whether it need do so, given that parties could always pursue class actions in federal court.

Finally, the Court of Appeals for Veterans Claims (CAVC) recognized the value of consolidating similar disability claims by veterans, but rejected class actions without more explicit authority to do so. The CAVC is the only non-Article III court we are aware of that has said it expressly lacks authority to hear class actions under its general powers to craft rules of procedure.

In contrast, the EEOC has heard petitions for class actions for over three decades. Even in the four years following the Supreme Court's decision in Walmart v. Dukes -- which some argue severely limits class actions in federal court--federal employees have filed over 125 class action claims with the EEOC. And the EEOC has kept up its practice of hearing class action claims even though, like the FCC and CFTC, federal employees may also pursue class action claims in federal court.

Based on our review of EEOC class actions filed over the past four years, they most commonly involve workplace discrimination claims based on race (28), sex (26), disability (24), and age (18). Of those cases, many follow the same pattern that class actions follow in federal court. A majority of cases were dismissed or remanded as untimely filed or on the merits. Twenty-two cases have settled. Of twenty-five actions where adjudicators considered whether or not to certify them as class actions, adjudicators rejected eighteen and certified seven for trial.

2. EEOC Class Action Procedures: Similarities and Differences from Federal Rules

EEOC class action procedures mostly track Rule 23(a) of the Federal Rules of Civil Procedure, with one important difference. Like federal courts, EEOC AJs hear class actions based on a petition, typically filed by lawyers from a highly specialized bar, demonstrating (1) that the proposed class is so numerous that a consolidated complaint of the members of the class is impractical; (2) that there are questions of fact common to the class; (3) that the claims of the agent of the proposed class are typical of the claims of the class; and (4) that the class or representative will fairly and adequately protect the interests of the class. As a result, EEOC AJs, like their federal counterparts, may require class wide discovery; appoint liaison counsel or certify class actions on the condition that parties obtain more experienced counsel; hear complex statistical evidence involving company-wide practices; and sometimes, sub-class to ensure parties with distinct interests are adequately represented at trial, or more commonly settlement.

But EEOC class actions have no equivalent to Rule 23(b) of the Federal Rules of Civil Procedure. That has at least two important consequences. First, unlike federal damage class actions, federal employees cannot " opt out" of an EEOC class action. After the EEOC certifies a class, and renders a class wide decision, employees only retain an individual right to challenge damages in " mini-trials" required by federal regulations.

Second, unlike some federal class actions, see Fed.R.Civ.P. 23(b)(3), EEOC class actions do not require that common questions " predominate" over individual issues before certifying a class action. This " predominance" requirement is often a difficult hurdle for parties to meet in federal court. Among other things, federal courts have rejected class actions that raise too many questions of law, vexing causation questions, and in rare cases, highly individualized damages because of a fear that individual issues among class members will overwhelm the common ones. As one influential scholar has described the 23(b)(3) " predominance" requirement:

[w]hat matters to class certification . . . is not the raising of common 'questions'--even in droves--but, rather, the capacity of a class-wide proceeding to generate common answers apt to drive the resolution of the litigation. Dissimilarities within the proposed class are what have the potential to impede the generation of common answers.

Other EEOC class action regulations resemble federal class actions under Rule 23(b)(2), which permit class actions for declaratory or injunctive relief where " the party opposing the class has acted or refused to act on grounds generally applicable to the class." EEOC cases involving structural reforms or declaratory relief tend to be less controversial because an injunction usually impacts all class members in the same way.

3. Values Served by EEOC Class Actions

In our conversations with EEOC AJs, they described two important values associated with the EEOC class action procedure. First, class actions permit the EEOC to consistently apply decisions to groups of claimants working for the same employer. Second, AJs saw the class action procedure as a way to pool information about employers' policies and assess their lawfulness--to identify patterns that otherwise might escape detection in an individual proceeding. In some cases, the scale and visibility of an EEOC class action itself attracts the attention of government agencies, leading to workplace reforms. For example, after an EEOC class of disabled applicants challenged the State Department's " world-wide" availability requirement for foreign-service workers--a policy that rejected candidates for promotion unless they could work without accommodation--the State Department was alerted to a systematic problem in its hiring practices.

Indeed, the design of the EEOC class action process appears to promote collaborative reform. Following an EEOC AJ's decision on the merits, the federal employer is given time to " accept, reject, or modify" the AJ's recommendations and final report. The employee then decides whether to appeal to the EEOC's Office of Federal Operations from the final agency decision.

Class actions before the EEOC rarely encourage the filing of what some call " negative value" claims--claims where the cost of litigation itself outweighs any potential award. There appears to be no shortage of claims filed against federal employers--and some of them are filed pro bono. The AJs we interviewed recognized that class actions can be time-consuming--observing that some class actions they had overseen had lasted for several years. However, they viewed their ability to hear class actions as important (1) to afford legal access to many similarly affected parties, (2) to enhance the EEOC's capacity to identify discriminatory policies by federal employers and consistently enforce substantive law, and (3) to assure the EEOC's continued ability to implement anti-discrimination policy in the wake of Supreme Court decisions that have limited employment class actions in federal court.

4. Challenges of EEOC Class Actions

Despite the AJ's generally positive view of EEOC class actions, they also identified some of the same challenges associated with complex litigation in state and federal courts, including concerns with diseconomies of scale, accuracy, and participation. First, EEOC class action proceedings are time-intensive. They may take years of motion practice, class discovery, appeals, and fairness hearings to determine the reasonableness of settlements. This means that before certifying a class AJs must ensure that a class action is feasible and likely to resolve the claims more efficiently than individual adjudications.

Second, AJs cited accuracy concerns associated with managing complex statistical evidence and other expert testimony. As a result, EEOC AJs may rely on procedures like Daubert hearings to screen out unreliable expert testimony and hold workshops in which they share insights on handling complex expert testimony.

Third, some AJs expressed concern about meaningful participation, given the fact that class members cannot opt-out of the class proceeding. They worried about the due process rights of absent class members who could not directly participate in or exit the action, and accordingly, felt additional pressure to assure that counsel adequately represented their interests before certifying the class action. The EEOC AJs have addressed this challenge by making extra efforts to ensure that attorneys representing a class with absent class members have sufficient experience, resources, and skill to adequately represent large groups of similar claims.

B. The National Vaccine Injury Compensation Program (NVICP)

Congress created the NVICP in 1986 to provide people injured by vaccines with a " no-fault" alternative to lawsuits in federal court. Under the program, claimants file a claim for compensation with the " Office of Special Master" (OSM), established for the purpose within the U.S. Court of Federal Claims, while serving the Secretary of Health and Human Services (HHS). Claimants are then entitled to a decision within 240 days based on a showing that the vaccine caused the injury. By mandating that people first file their vaccine injury claims with the NVICP, Congress hoped to reduce lawsuits against physicians and manufacturers, while providing those claiming vaccine injuries an expedited claim process and a reduced burden of proof. Claimants under the NVICP, unlike those who sue, do not have to prove negligence, failure to warn, or other tort causes of action; they must only prove that a covered vaccine caused their injury. A seventy-five cent excise tax for each dose of vaccine sold goes to a trust, which in turn, funds awards and the administrative costs of the Program.

Generally a petitioner can get compensation under the vaccine injury program in two ways. In a " table" case, the petitioner has an initial burden to prove an injury listed in the Vaccine Injury Table. Upon satisfying this initial burden, the petitioner earns a " presumption" that the vaccine caused his or her injury. The burden then shifts to HHS to prove that a factor unrelated to the vaccination actually caused the illness, disability, injury, or condition. Petitioners can also get compensation for " off-table" cases. The petitioner in an off-table case has the burden to prove the vaccination in question " caused" a particular illness, disability, injury, or condition. The NVICP originally covered vaccines against seven diseases: diphtheria, tetanus, pertussis, measles, mumps, rubella (German measles), and polio. Congress has since extended coverage to a total of sixteen vaccines.

OSM adjudicators possess an interesting mix of powers--falling somewhere in between Article I judges and agency adjudicators. On the one hand, Congress expressly considered--and then rejected--creating a new department within HHS to hear claims arising out of the vaccine program. Moreover, the OSM sits in the U.S. Court of Federal Claims, and parties may appeal their decisions to the court. On the other hand, the OSM must follow special procedures created specifically for the vaccine program, lacks formal authority to hear class actions or use other multi-party procedures, and receives as much weight and deference for the medical and scientific findings as other agency adjudicators--their decisions may only be set aside on appeal if found " arbitrary and capricious."

Like most benefit programs, many vaccine claims proceed one at a time. However, sometimes, this small office of eight adjudicators has had little alternative but to find ways to streamline the disposition of large groups of cases--particularly those raising similar scientific questions. Relying on its inherent authority to use " specialized knowledge" to resolve common scientific questions in a consistent and informed way, the OSM has relied upon combinations of procedures that loosely resemble multidistrict litigation, bellwether hearing procedures, and creative case-management techniques to efficiently resolve cases that raise common scientific questions, in ways designed to increase public participation and input.

1. The Origins of the Omnibus Proceeding

One way that the OSM has handled large groups of claims raising similar scientific questions is through the " omnibus proceeding." In an omnibus proceeding, a single adjudicator or set of adjudicators will hear claims that raise the same general scientific question of causation. Even though the Act that created the vaccine program contains no provision for class action suits (or anything like it), special masters developed the concept of the omnibus proceeding because the " same vaccine and injury often involve the same body of medical expertise." Counsel representing large groups of individual claimants often use an omnibus proceeding to answer questions of " general causation," like whether a particular vaccine is capable of causing a specific injury. The hope is that the issue of whether a vaccine did so in a specific case can then be resolved more expeditiously.

Special Masters have pointed to two sources of informal authority to justify this procedure. First, they point to the broad discretion afforded Special Masters in the adjudication of claims that arise out of the program. Among other things, the Vaccine Act permits special masters to make evidentiary findings without following the formal rules of evidence, and gives them broad license " to determine the format for taking evidence and hearing argument." Second, the OSM has pointed to their expertise as a rationale to democratize and open up the hearing process when the same cases raise similar questions of scientific causation. As Chief Special Master Vowell observed:

The Court of Federal Claims has noted that " instead of being passive recipients of information, such as jurors, special masters are given an active role in determining the facts relevant to Vaccine Act petitions," and that " the special masters have the expertise and experience to know the type of information that is most probative of a claim." The U.S. Court of Appeals for the Federal Circuit has commented on the " virtually unlimited" scope of the Special Master's authority to inquire into matters relevant to causation, and the deference properly accorded to their fact-finding. Notably, federal district court judges have similarly relied on their discretion to control evidence and their familiarity with complex scientific questions to justify similar forms of procedural innovation.

The use of omnibus proceedings dates back to 1992, when Special Master George Hastings decided an omnibus proceeding involving 130 cases that alleged a rubella vaccine caused chronic arthritis and other related problems. In that case, he observed early on that a large number of similar claims presented the general question over whether or not rubella could cause chronic arthopathy, and sua sponte, encouraged plaintiffs' attorneys who had filed such claims to form a steering committee to coordinate the presentation of expert evidence on the condition. Special Master Hastings found that " each case has an issue in common with the other cases, i.e., whether it can be said that it is 'more probable than not' that a rubella vaccination can cause chronic or persistent [arthropathy]." The Special Master thus conducted an inquiry into this " general" question for the benefit of each of the related cases " with the hope that knowledge and conclusions concerning the general causation issue . . . could be applied to each individual case."

At the time, there was " only a very, very limited amount of data directly applicable" because " this issue really ha[d] not been scientifically studied." Accordingly, the Special Master gave petitioners a great deal of time to develop general causation evidence. At the general causation hearing, Special Master Hastings then evaluated a range of evidence that applied to this " general causation" question--including several isolated cases of chronic arthritis following the rubella vaccination, a study that discussed several cases of chronic joint pain, certain evidence of pathological markers, and formal expert testimony. At the end of the hearing, Special Master Hastings conceded that the evidence, while " not overwhelming" generally supported a causal link between the rubella vaccine and chronic arthritis. He then entered a case management order requiring individual parties to put forward evidence consistent with his findings--acute onset of arthritis, no history of pre-existing conditions, as well as other evidence--to qualify for compensation.

The general proceeding helped expedite the evaluation of a common, as well as still-evolving scientific question of general causation. In addition, the proceeding made otherwise " small dollar" claims for joint pain worthwhile. " Following the 1993 Decision, over 130 related cases were either resolved or voluntarily dismissed based upon the Special Master's findings." Moreover, by forcing the parties to pool together common scientific evidence on the issue, he raised the attention of an issue that, up to that time, had escaped the attention of HHS as well as Congress. Shortly after the decision, the Vaccine Injury Table was administratively modified, consistent with Special Master Hastings' decision, to include " chronic arthritis" as a Table injury associated with the rubella vaccine. As a condition of establishing a table injury for chronic arthritis, a petitioner must demonstrate that a physician observed actual arthritis (joint swelling) in both the acute and chronic stages.

The Vaccine Program uses two types of omnibus proceedings. The first involves hearing evidence on a general theory of causation--like whether or not, as Special Master Hastings' considered, a rubella vaccine causes chronic arthritis or other categories of joint problems. The Special Master makes findings based on that evidence and orders the parties to file papers establishing the extent to which the facts of individual cases fit within the court's general findings. For example, counsel representing a large number of petitioners and counsel for respondent may file expert reports and medical journal articles to support the theory that the rubella vaccine is associated with chronic arthritis. The special master then (1) conducts a hearing in which the medical experts testify, (2) publishes an order setting forth the conclusions, and (3) files it in each of the rubella cases. If he or she finds sufficient evidence that the rubella vaccination could cause chronic arthropathy under certain conditions, the Special Master may order individual petitioners seeking compensation to establish those conditions in a separate filing. Alternatively, the omnibus proceeding applies evidence developed in the context of one individual case to other cases involving the same vaccine and the same or similar injury, much like an issue class action.

According to Chief Special Master Vowell, however, most omnibus proceedings work like bellwether trials in federal district court--organizing individual cases that raise similar issues in front of the same adjudicator, in the hopes that the outcome in one or a few cases will help other similarly situated parties understand the strengths and weaknesses of their cases, thereby facilitating the settlement of the remaining cases:

Most omnibus proceedings . . . have involved hearing evidence and issuing an opinion in the context of a specific case or cases. Then, by the agreement of the parties, the evidence adduced in the omnibus proceeding is applied to other cases, along with any additional evidence adduced in those particular cases. The parties are thus not bound by the results in the test case, only agreeing that the expert opinions and evidence forming the basis for those opinions could be considered in additional cases presenting the same theory of causation.

Special Masters adopted this approach in the " Omnibus Autism Proceeding," which was established in order to determine whether a causal link existed between childhood vaccines and autism. Between 2005 and 2006, over 5,000 cases alleging an association between autism and either the MMR vaccine (which does not contain thimerosal) or vaccines containing the preservative thimerosal, or both, have been filed with the NVICP. Three special masters structured discovery, motion practice, and expert testimony to hear three separate " test cases" on this theory of general causation.

In so doing, the special masters in each case considered a wealth of scientific evidence common to every case. As Chief Special Master Vowell observed: " The evidentiary record in this case . . . encompasses, inter alia, nearly four weeks of testimony, including that offered in the Cedillo and Hazlehurst cases; over 900 medical and scientific journal articles; 50 expert reports (including several reports of witnesses who did not testify); supplemental expert reports filed by both parties post-hearing, [and] the testimony of fact witnesses on behalf of [the injured child and his] medical records." Although non-binding, the findings in those three cases--which found no causal connection between vaccines and autism--helped the remaining claimants evaluate the strength and merits of their claims in the vaccine program.

2. Challenges of Omnibus Proceedings

There are drawbacks associated with omnibus proceedings. First, some agencies use ALJs who are assigned randomly to each individual case to reduce allegations of bias or gamesmanship. Such agencies would have to take greater care to ensure that ALJs were randomly assigned as much as possible.

Second, omnibus proceedings raise interesting questions about the legitimacy of using an adjudication process to settle complex scientific questions. Many plaintiffs in the Omnibus Autism Proceeding were anxious about commencing cases together, as were members of the public health community, who " found it unsettling that the safety of vaccines must be put on trial before three " special masters" in an obscure vaccine court. Said one: " the truth about scientific and medical facts is not, ultimately, something than can be decided either by the whims of judges or the will of the masses." Others, however, found that the ability to hear common cases together led to deliberations that represented a " comparatively neutral exhaustive examination of the available evidence."

Finally, Special Masters and staff had to invest substantial resources tracking, assessing attorney's fees for, and closing individual cases still pending long after the court resolves common questions involving the Omnibus Autism Proceeding. To alleviate these problems, the Special Master's office may in the future require those who agree to participate in future omnibus proceedings to be bound by the outcome of such " test cases."

C. Office of Medicare Hearings and Appeals (OMHA)

The Office of Medicare Hearings and Appeals (OMHA) operates in HHS and hears appeals involving Medicare benefits. OMHA was created by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the Medicare Modernization Act). Before 2003, ALJs in the Social Security Administration (SSA) heard Medicare appeals under a Memorandum of Understanding between SSA and HHS. The Medicare Modernization Act addressed concerns that SSA ALJs lacked guidance to handle the distinct issues raised in Medicare appeals.

OMHA is the third of four levels of administrative appeals available in the Medicare health insurance program--Medicare Parts A, B, C, and D. Medicare Parts A & B (or " Original Medicare" ) include Hospital Insurance (Part A) and Supplementary Medical Insurance (Part B). Part A helps pay for inpatient care in a hospital or skilled nursing facility (following a hospital stay) and some home health care and hospice care. Part B helps pay for doctors' services and other medical services, equipment, and supplies that are not covered by hospital insurance.

The Medicare appeals process varies depending on which Part is involved, but Medicare Parts A and B are most relevant to OMHA's use of aggregation. Under Medicare Parts A and B, the reimbursement process generally begins with a provider or supplier submitting a bill to Medicare for a service they performed for a covered beneficiary. In order to validate payment of the claim, Medicare uses private contractors called Medicare Administrative Contractors (MACs) to determine that the claim is covered or reimbursable and the amount that is payable by Medicare. These contractors then notify the claimant of the amount recoverable and administer payment. If the claimant disagrees with the decision, the claimant can request a redetermination by the MAC. The redetermination is processed by the same MAC, but by a different individual in the MAC than the person who processed the original claim.

If the claimant is not satisfied with the redetermination by the MAC, it can initiate a Level 2 appeal, which will be reviewed by a Qualified Independent Contractor (QIC) retained by CMS, who reconsiders the medical necessity of the services provided to the covered beneficiary. If the claimant is not satisfied with the QIC's decision, the claimant may appeal the QIC's determination to OMHA.

Parties may appeal the decision of OMHA under any Part to the Medicare Appeals Council, which is part of the Departmental Appeals Board of HHS and independent of OMHA and its ALJs. The decisions of the Medicare Appeals Council are themselves subject to review in federal district court if the amount in controversy is at least $1,350.

1. The Backlog in OMHA Appeals

The OMHA appeals process began to experience significant backlogs in 2012. The number of appeals received by OMHA grew from 59,600 in 2011 to 117,068 in 2012, 384,151 in 2013, and 473,563 in 2014. Put differently, the number of claims increased 800% from 2006 to 2014. Meanwhile, the number of appeals decided by OMHA only grew from 53,864 in 2011 to 61,528 in 2012, 79,377 in 2013, and 87,270 in 2014. Thus, despite the increased productivity of OMHA's ALJs and the total number of appeals decided each year, OMHA could not keep pace with the huge number of new cases coming in the door. As a result, average wait times for the processing of appeals grew from 121 days in 2011 to 603 days in 2015.

Most of the increased number of appeals involved claims under Medicare Part A and Part B. The dramatic surge in these appeals was caused primarily by stepped up efforts to recover excess billing under several post-payment audit programs conducted by private contractors and more active Medicaid State Agencies. In addition, there was a larger beneficiary population during this period.

It is important to note, however, that appeals by individual beneficiaries receive priority processing. Thus, most of the parties suffering from the delays caused by the backlogs were businesses--often service providers or medical suppliers--with sometimes hundreds or thousands of similar appeals on behalf of different Medicare beneficiaries.

Faced with an existential crisis, OMHA began to explore ways to reduce the backlog and process a much larger number of appeals without adding more ALJs. Among several initiatives, OMHA introduced two pilot programs using aggregation mechanisms to resolve large groups of claims in a single proceeding: (1) the Statistical Sampling Initiative; and (2) the Settlement Conference Facilitation.

2. OMHA's Power to Aggregate Appeals

Section 931 of the Medicare Modernization Act directs the Secretary of HHS to establish " specific regulations to govern the appeals process." The Secretary has utilized her broad discretion to develop administrative procedures to promulgate regulations authorizing OMHA ALJs to consolidate two or more cases in one hearing at the request of the appellant or on " his or her own motion," " if one or more of the issues to be considered at the hearing are the same issues that are involved in another hearing or hearings pending before the same ALJ." The purpose, as described in the regulations, is " administrative efficiency." After the hearing, the ALJ may issue either a consolidated decision and record or separate decisions and records for each claim.

Although OMHA ALJs rarely formally consolidate appeals, ALJs often informally combine appeals to be heard in the same proceeding even without a formal consolidation order or process, when the appeals involve the same organization, issues of law or fact, or the same representative. Consider the following three examples:

(1) Same appellant and related issues. A large durable medical equipment provider appeals claims for oxygen, continuous positive airway pressure supplies, and inhaled medications. Although an ALJ may hear separate fact specific arguments on each case, " there are efficiencies in having one proceeding, with procedural statements, witness introductions, oaths, and waiver of counsel done once at the beginning." Also, there are common arguments that can be made at the start of the hearing or in the first case with that particular issue and not repeated. The documents are often common and can be explained once if there are any questions.

(2) Same appellant and common issues of law and fact. When a lab provides DNA testing of cancer cells to determine appropriate chemotherapy treatment, there may be a question about whether the procedure is " investigational" or " experimental" (and therefore not covered by Medicare). The case will often involve the review of medical literature and physician testimony. The entire group of appeals assigned to the ALJ can be heard together. The ALJ may review the records in a few files, but there are typically no individualized factual determinations. In such cases, an ALJ may still offer the appellant the right to present on all of the cases, but the parties " typically rest on the more general arguments and waive the right to separate hearings in each case."

(3) Same representative appearing on behalf of multiple appellants with no testimony or participation by the appellant's employees. A law firm or other organization represents hospitals in cases in which overpayments were assessed after a RAC review. The issue in all of the cases is whether the services should have been billed as inpatient (Part A) or outpatient/observation (Part B, which generally have a lower payment). The RAC will often appear as a party (they are paid a contingent fee based on the recovery), and other Medicare contractors may also appear as participants or parties. OMHA would typically schedule these cases in groups by representative and RAC.

3. OMHA's Statistical Sampling Initiative

(a) Background on Statistical Sampling in the Medicare Program Aside from the kinds of group procedures described above, the Medicare program has used statistical sampling since 1972 to estimate Medicare overpayments in light of the enormous administrative burden of auditing businesses on an individual claim-by-claim basis. In Chaves County Home Health Servs. v. Sullivan, the U.S. Court of Appeals for the District of Columbia Circuit approved the use of statistical sampling to determine Medicare overpayments, reasoning that even though the Medicare Act did not expressly authorize its use, the D.C. Circuit would defer to the Medicare program's adoption of statistical sampling as a " judicially approved procedure that can be reconciled with existing requirements" under the principles set forth in Chevron U.S.A. Inc. v. NRDC. In so doing, the D.C. Circuit also pointed to longstanding uses of statistical sampling in other contexts. Nevertheless, the D.C. Circuit distinguished the use of statistical sampling in post-payment review from individualized pre-payment claim review.

Courts have also consistently rejected claims that statistical sampling in the Medicare and Medicaid programs violates due process under the Mathews v. Eldridge balancing test, reasoning that the private interest " at stake is easily outweighed by the government interest in minimizing administrative burdens."

The use of statistical sampling and other aggregation techniques in Medicare appeals, as opposed to the CMS auditing program, emerged " organically" in the late 1990s. SSA ALJs began using them to manage Medicare disputes that involved large numbers of similar claims before the same adjudicator. Both ALJs and the parties themselves would propose the use of statistical sampling to expedite such claims. Statistical sampling was advantageous to providers who did not want to spend the significant time necessary to produce documentation for every claim for which they sought reimbursement. As a matter of policy, OMHA often required that parties consent before performing statistical sampling, reasoning that the use of statistics could save time and resources from relitigating similar issues at OMHA.

(b) Statistical Sampling Pilot Program

As the number of Medicare Part A and Part B appeals spiked, OMHA formally adopted the Statistical Sampling Initiative (SSI) as a way to formalize and systematize the process that had begun with individual ALJs. OMHA proceeded cautiously in designing the pilot program, concerned that its backlog elimination efforts might create new backlogs. OMHA also had to address concerns of DOJ and CMS about allowing companies with a history of fraud or wrongdoing to participate in the pilot program.

OMHA attorneys, ALJs, and statisticians developed criteria for piloting the new program on a limited basis. The pilot program was restricted to appellants with at least 250 claims on appeal that fell into certain specified categories of Part A or Part B claims and were currently assigned to an ALJ or filed within a 3-month period in 2013, but not yet scheduled for a hearing. Although appellants may request statistical sampling of their own accord, none have done so to date. Rather, OMHA has invited certain appellants to participate in the program. In order to identify claims appropriate for statistical sampling, OMHA used its own database to identify large numbers of appeals from the same provider. Based on these " data runs," OMHA made offers to eight providers to participate in the sampling program. Seven parties agreed to participate in the program and one party declined.

Most of the eligible participants in the program to date are providers of medical supplies and equipment. Notably, a single diabetic supplies proceeding would account for 17,134 claims, dwarfing the other statistical trials, which only resolve caseloads of 400 to 600 cases at a time. Our interviewees suggested that these cases lend themselves to sampling because the claims involved are more similar than inpatient provider care, which is more varied and individualized.

Although OMHA ALJs rotate randomly, a small number of ALJs have committed to be randomly selected within the statistical sampling program. This allows OMHA to take advantage of their expertise in handling such matters. OMHA is guided special policies on statistical sampling. In short, a statistician selects the sample from the universe of claims, the ALJ makes decisions based on the sample units, and the statistician then extrapolates the results to the universe of claims.

(c) Challenges of the Statistical Sampling Initiative

Although OMHA plans to expand the statistical sampling program, OMHA identified a number of challenges. First, OMHA adjudicators and staff were mindful that aggregation risks creating diseconomies of scale--they strongly hoped to avoid aggravating backlogs and claims by creating an unmanageable aggregate litigation process, particularly given limited staff and large caseloads. Second, OMHA sought to ensure adjudicators possessed sufficient expertise to hear large complex disputes, given that ALJs ordinarily hear individual cases. Third, service providers and other appellants expressed legitimacy concerns; they worried that aggregate proceedings in front of the wrong adjudicator or with the wrong methodology could jeopardize their day in court. Finally, some worried that there was not enough information about the statistical sampling methodology that would be used in the SSI.

OMHA addressed the question of efficiency by taking a very conservative approach to the pilot program so as not to create a new backlog while attempting to deal with its existing backlog. The pilot program was initially confined to appeals already assigned to ALJs or filed during a single quarter of 2013. In addition, the ALJs participating in the pilot did so on a voluntary basis, and their work in the pilot program is in addition to their regular workload.

The pilot program addressed the challenge of expertise by selecting ALJs to participate with experience in statistical sampling. This, of course, is in some tension with the random assignment of ALJs, as it creates a smaller pool from which an ALJ is drawn.

After providers expressed concern with having one ALJ hear large numbers of their claims, OMHA began outreach efforts to bolster the legitimacy of the pilot program, but it plans to do more on this front in the future. In addition to addressing the " all eggs in one basket" concern, OMHA may want to be mindful of other challenges as it expands the program.

(d) Expansion of the Statistical Sampling Initiative

OMHA is currently considering expanding the program beyond the limited universe of appeals eligible to participate in the pilot program. In connection with the expansion, OMHA is weighing additional outreach efforts, increased staffing levels, and restructuring the adjudication process to make the program more appealing to medical providers who are otherwise unfamiliar with the use of sampling.

An expanded statistical sampling program may use multiple ALJs to hear different parts of a sample of claims. For example, instead of a single ALJ hearing a sample of 100 cases, ten ALJs might each hear ten cases from the sample. This would help to allay appellants' concern that statistical sampling before a single ALJ risks a bad decision being extrapolated across the entire universe of claims. Many Medicare claims appellants are repeat players who have positive or negative opinions about particular ALJs. Indeed, our interviewees suggested that some appellants already try to exploit the power of ALJs to consolidate appeals to " ALJ shop." For example, an appellant with multiple appeals pending before different ALJs might request that all its cases be consolidated with the ALJ the appellant believes will provide it with the most favorable decision. Spreading the sample among more than one randomly selected ALJ will help alleviate the concern that the entire universe of claims will be decided by an ALJ that the party hopes to either avoid or obtain.

Expanding the statistical sampling program may also help overcome challenges faced by many mass government benefits programs. Agencies frequently struggle to consistently hear cases in mass adjudication systems, like OMHA, where appellants continually file appeals involving similar legal and factual issues, and even on the same issue for the same beneficiary with a different service date. However, consolidating large numbers of appeals in a smaller number of proceedings using statistical sampling may make it easier to track these decisions.

Moreover, aggregating large numbers of appeals in a smaller number of proceedings using statistical sampling may make it easier for the Secretary to coordinate the work of OMHA with other agencies and departments. The relationship between CMS and OMHA can make it difficult to implement uniform policy. OMHA may approve a payment on appeal and the next day CMS can deny the same provider's claim on behalf of the same beneficiary for the same DME, with only a different date of service. Indeed, even the Medicare Appeals Council, which issues the Secretary of HHS's final decision in these appeals, does not bind OMHA and CMS beyond the appeals that it reviews. Aggregate adjudication provides agency heads with an opportunity to take a thoughtful first crack at important questions of law and policy by the agency's most experienced and expert adjudicators, with the benefit of a fully developed record and competent counsel.

Along the same lines, agency aggregation may increase the ability of the political branches to ensure agency accountability. Policymakers are rarely concerned with the outcomes of individual adjudications beyond the provision of constituent services by individual representatives. But aggregated cases, like Medicare's recent billion dollar settlement with over 1,900 hospitals, can generate significant interest in Congress.

4. OMHA's Settlement Conference Facilitation Initiative

In addition to statistical sampling, OMHA has begun to experiment with an aggregate settlement initiative. CMS has always had discretion to settle disputes with Medicare providers and suppliers, but the Settlement Conference Facilitation (SCF) Pilot represents an effort by OMHA to provide a formal framework for encouraging the settlement of large numbers of cases.

The SCF Pilot began in June 2014. Once again mindful of avoiding the creation of new backlogs, the SCF Pilot was limited to groups of at least 20 appeals or appeals comprising at least $10,0000 in the aggregate filed in 2013 and that met certain specified criteria. To qualify for the program, claims must be part of the Medicare Part B program, which usually involves durable medical equipment (DME), but also can involve outpatient therapy, physical services, and other more individualized forms of treatment. Appeals run the gamut of Part B DME claims (e.g., prosthetics, robotics), skilled nursing services (these are usually under Part A, but appellants can get a reduced amount under Part B), outpatient rehabilitation services (Part B or Part A), and even some drugs and biologicals.

The claims must be for the " same" or sufficiently " similar" items or services to qualify for the SCF pilot program. OMHA takes a " common sense" approach to the meaning of " same" or " similar." For example, all wheelchairs, whether electronic or manual, or nutritional supplies for people with digestive troubles, including both the nutritional supplements and the device to deliver them, would be the " same" or " similar" items. But wheelchairs and diabetes test strips are not related, even if stemming from the same illness, and would not be the " same" or " similar."

Under the pilot program, OMHA facilitates a discussion between CMS and the appellant regarding potential resolution through settlement. OMHA devoted one attorney trained in facilitation, working full-time along with four other trained facilitators working on a rotating basis. This attorney and a second mediator attend each settlement conference as a team. If the parties reach an agreement, a settlement agreement is drafted by OMHA and signed by the parties. OMHA then dismisses the appeals. If no agreement is reached, the appeals return to their prior status and positions in the appeals queue.

OMHA has found that many appellants are more comfortable with mediation, particularly given the plethora of courthouse programs designed to promote alternative dispute resolution. OMHA received twenty-five requests for settlement conferences in connection with the pilot project. OMHA did not itself invite any parties to participate in the pilot program (in contrast to the statistical sampling initiative) because enough parties applied on their own, and OMHA has limited resources to devote to the pilot.

Phase I resolved 2,400 appeals. Most of the settlements resolved something in the range of 200 appeals. A few resolved 500 to 700 appeals. This is equal to the number of cases typically resolved by two ALJ teams working for one year. Each ALJ team is composed of four to six people, including the ALJ, attorneys, paralegals, and other staff assistants. Phase I of the SCF Pilot was staffed by the attorney trained in facilitation, a program analyst, a management assistant, and five facilitators.

As OMHA expands the cases eligible for the SCF program, it has sought to eliminate the risk of uncommon, unclear and cherry-picked cases that undermine aggregation. First, only after determining that the appellant has appeals appropriate for the SCF program based on their similarity, does OMHA invite the appellant to apply to participate in the program. Second, the claims appealed must be ascertainable. They may not involve items or services billed under unlisted, unspecified, unclassified, or miscellaneous healthcare codes. These claims are difficult to settle because they do not have an approved reimbursement amount.

Third, settlement discussions must be comprehensive. The request must include all of the party's pending appeals for the same items or services that are eligible for SCF. For example, if an appellant has fifty wheelchair appeals pending that meet the SCF requirements, the appellant must request SCF for all fifty wheelchair appeals. In addition, appellants may not request SCF for some but not all of the items or services included in a single appeal. This prevents parties from submitting their weakest appeals to the settlement process and going to hearings with their strongest appeals.

D. Challenges and Benefits of Aggregate Agency Adjudication

Each case study illustrates the unique benefits and challenges offered by aggregate agency adjudication. Like federal courts, each tribunal has used aggregate adjudication to pool information about common and recurring problems, as well as to eliminate the duplicative expenditure of time and money associated with traditional one-on-one adjudication. They have also sought more consistent outcomes in similar cases than possible with case-by-case adjudications. Finally, aggregation has proved to be an important method to improve access to legal and expert assistance by parties with limited resources, so that individuals can pursue claims that otherwise would be difficult to pursue on an individual basis.

But, as also illustrated above, aggregate agency adjudication raises unique challenges and costs of its own by: (1) potentially creating " diseconomies of scale" --inviting even more claims that stretch courts' capacity to administer justice to many people; (2) impacting the perceived " legitimacy" of the process and challenging due process; and (3) increasing the consequence of error. In other words, just like many kinds of administrative systems, aggregate adjudication struggles to deal with many different kinds of constituencies feasibly, legitimately, and accurately.

Nevertheless, each program has responded to these concerns by adopting aggregate procedures responsibly. They have cautiously piloted aggregate procedures to avoid replacing new backlogs with old ones. Where appropriate, they have also relied on panels of adjudicators to reduce allegations of bias and provided additional opportunities to assure individuals voluntarily participate in the process. Finally, some have developed guidance to standardize the use of statistical evidence, while others require cases raising novel factual or scientific questions to mature before centralizing claims before a single decisionmaker. This part summarizes the benefits of aggregation and the ways that these agencies have attempted to respond to their challenges.

1. Aggregate Adjudication Can Pool Information, Reach Consistent and Efficient Outcomes, and Improve Legal Access

As set out above, when used effectively, aggregate agency adjudication may fulfill important goals of efficiency, consistency and access in adjudication.

Promoting Efficiency.

The efficiencies afforded by aggregation can be especially helpful in the administration and review of large benefit programs, such as those reviewed by the NVICP and OMHA. For example, when over 5,000 parents claimed that a vaccine additive called thimerosal caused autism in children, the NVICP used a national Autism Omnibus Proceeding to pool all the individual claims that raised the same highly contested scientific questions. In the words of one Special Master, omnibus proceedings have " turned out to be a highly successful procedural device," facilitating settlement of individual cases and allowing those cases that proceed to a hearing to be resolved " far more efficiently than if we had needed a full blown trial, with multiple expert witnesses, in each case." Similarly, both of OMHA's programs have been so successful that medical providers are urging OMHA to expand opportunities to aggregate and settle large numbers of claims.

Promoting Consistency.

Aggregate procedures can provide uniform and consistent application of the law, particularly in cases seeking indivisible relief, like injunctions or declaratory relief. Absent a class action, a court may never hear from plaintiffs with competing interests in the final outcome, or over time, subject defendants to impossibly conflicting demands. The EEOC, for example, has long claimed its class action procedure was important to consistently resolve " pattern and practice" claims of discrimination by federal employees. The EEOC deems the process important in light of the volume of claims it processes each year, the potential for inefficient and inconsistent judgments, and the otherwise limited access to counsel. OMHA adjudicators have similarly observed that aggregate procedures have been vital to ensure hospitals and medical suppliers with hundreds of the same claims, sometimes for the same beneficiary, were reimbursed consistently.

Promoting Legal Access and Generating Information.

Finally, aggregate agency adjudications illustrate how aggregate proceedings can foster legal access, while pooling information about policies and patterns that otherwise might escape detection in individualized trials. The EEOC, for example, observed its " class actions . . . are an essential mechanism for attacking broad patterns of workplace discrimination and providing relief to victims of discriminatory policies or systemic practices." In some cases, the scale and visibility of an EEOC class action itself attracts the attention of government agencies, leading to workplace reforms.

Similarly, the NVICP's omnibus proceedings allow any party alleging a vaccine-related injury to benefit from the record developed in test cases and general causation hearings by the most qualified experts and experienced legal counsel. In one of the NVICP's first omnibus proceedings, the parties pooled common scientific evidence on the issue of whether a rubella vaccine caused chronic arthritis. As a result, the proceeding raised the profile of an issue that, up to that time, had not been in focus for the HHS as well as Congress. As noted above, shortly after the decision, the Vaccine Injury Table was administratively modified, consistent with the decision, to include chronic arthritis as an injury generally associated with the rubella vaccine.

As these examples illustrate, aggregation procedures may offer agencies another way to efficiently and consistently expand access to agency tribunals, while improving the caliber of representation and information provided to them.

2. Addressing Concerns of Efficiency, Legitimacy, and Accuracy in Aggregate Agency Adjudication

Even as agencies adopt aggregate procedures, they confront long acknowledged concerns about aggregation in federal court, including fears of inefficiency, legitimacy and accuracy.

Efficiency .

First, agency adjudicators and staff observed that aggregating claims raises the possibility of diseconomies of scale--inviting more backlogs and claims difficult to manage with limited staff and large caseloads. OMHA adjudicators and personnel acknowledged they hoped to avoid creating " a backlog to another backlog" when it developed a formal program to use statistical evidence to resolve large groups of common claims commenced by a single provider or supplier. AJs with the EEOC, all with decades of experience hearing class actions, observed that class action proceedings involved substantial time and resources, sometimes requiring extensive motion practice and complex statistical proofs to establish unlawful patterns of discrimination. Even more informal aggregation, like the NVICP's Omnibus Proceedings, has required adjudicators to invest resources tracking and closing individual cases still pending long after the court resolves common questions involving a particular vaccine.

In each case, however, adjudicators have responded to concerns about inefficiency by using aggregate tools cautiously, through active case management; relying on experienced counsel and special masters to avoid duplicative motions; and where appropriate, by encouraging settlement. OMHA, for example, rolled out its pilot statistical sampling program for a very limited category of claims, those filed before 2013; actively identified cases, using its database, to find appellants with large volumes of identical claims; and proceeded on a voluntary basis, with the consent of the parties. Special Masters in NVICP rely on steering committees of private lawyers to organize and manage common discovery. They also often allow evolving scientific and novel factual questions to " mature" --putting off centralizing novel cases involving a single vaccine until receiving the benefit of several opinions and conclusions from different Special Masters about how a case should be handled expeditiously. EEOC AJs similarly rely on experienced bar and active judicial management to expedite cases for trial and, in many cases, settlement.

Still, an overly cautious approach can also limit the full value of agency aggregation. For example, OMHA's Statistical Sampling Initiative is hindered in what it can achieve by both the limited pool of eligible claims and its decision to require the parties' affirmative consent to participate in the program. At this point, not enough parties have been willing to consent to statistical sampling for it to make a significant dent in the backlog. As long as it remains an entirely voluntary program, OMHA will need to build greater trust among appellants to realize the program's full potential as an aggregation mechanism.

Legitimacy .

Adjudicators and staff also highlighted concerns about legitimacy--particularly given that the model for administrative adjudication typically imagines individualized hearings in which each claim has its day in court before a neutral decisionmaker. EEOC AJs, for example, noted that the inability of parties to opt-out of class actions seeking damages was an additional source of " pressure" for adjudicators to make appropriate decisions and narrowly define the class. Some hospitals and medical suppliers reported that they resisted OMHA's statistical sampling program out of a fear that a single adjudicator's view about the medical necessity of a small sampling of claims would be extrapolated to thousands of others. Even omnibus proceedings raise interesting questions about the legitimacy of using an adjudication process to settle complex scientific questions. Many plaintiffs in the Autism Omnibus Proceedings were anxious about commencing cases together, as were members of the public health community, who as noted above " found it unsettling that the safety of vaccines must be put on trial before three 'special masters'" in an obscure vaccine court.

Each of these systems have responded to these concerns by diversifying decisionmaking bodies, assuring adequate representation, and increasing opportunities for individual participation and control in the aggregate proceeding. Special Masters in the Vaccine Program, for example, relied on a panel of three adjudicators in the Autism Omnibus Proceeding to allay concerns about bias. As OMHA considers expanding its statistical sampling initiative, some of its members have said they will consider permitting multiple adjudicators to hear sampled cases. Finally, the EEOC relies on many rules adopted from the Federal Rules of Civil Procedure to increase legitimacy and participation, scrutinizing and screening class counsel to ensure they adequately represent class members; holding " fairness hearings" where class members can voice their concerns with any proposed resolution or settlement; and, in a departure from the federal rules, requiring mini-trials to test individual claims and defenses remaining in adjudications involving damages.

Accuracy .

Finally, each case study illustrates how the efficiency with which aggregation resolves large numbers of claims puts pressure on the ability of adjudicators to achieve accurate decisions, when concentrating many cases before the same judge. As noted, many appellants before OMHA worried about the accuracy of any final statistical extrapolation. EEOC AJs observed that unlike federal judges, who benefit from the Reference Manual of Scientific Evidence, no similar guidance exists for EEOC judges tasked with deciding statistical or other technical evidentiary questions frequently raised in EEOC proceedings. Special Masters in the NVICP exist precisely because Congress assumed that over time they would develop expertise in the complex medical and scientific questions frequently raised in the program; and yet, in proceedings where groups allege new theories of general causation for large numbers of vaccines, decisionmakers warned of the importance of getting the science right in a single adjudication.

Agencies have responded to these concerns, as well, by requiring that aggregated claims are sufficiently similar to avoid distorting outcomes and by developing guidelines and screens to address complex statistical evidence. OMHA, for example, relies on its database of billing codes to ensure that claims are sufficiently similar to warrant aggregation, and uses statistical experts along with detailed guidelines for statistical evidence. Special Masters in NVICP wait for cases to mature before treating them in groups, which helps assure that hasty decisions do not adversely impact other related claims; adjudicators also afford attorneys additional time to assure their experts have time to develop and understand the relationship between a vaccine and a new disease. EEOC AJs, like the federal courts, still carefully screen complex evidentiary issues common to the class, relying on guidelines long-established in federal court under Daubert v. Merrell Dow Pharmaceuticals, Inc.

III. The Forms and Limits of Agency Adjudication

The EEOC, NVICP, and OMHA demonstrate the potential of aggregation to improve agency adjudication in a variety of ways. But most administrative proceedings remain highly individualized. Even most informal adjudications, which are not governed by any of the structural protections of the Administrative Procedure Act, often proceed in a traditional, individualized, case-by-case manner. Our own surveys and interviews with lawyers, adjudicators and staff from more than 25 agencies found very few ever considered the use of class actions or other multiparty procedures.

So what explains the limited use of aggregation by federal agencies to date? And what, if anything, can it tell us about how agencies and policymakers view the relationship between adjudication, rulemaking and enforcement?

We explore three explanations below. First, agencies may resist aggregate adjudication because they believe Congress or agency policymakers may better resolve large groups of claims through prospective legislation or a rulemaking process. Second, and related, agencies may resist aggregate procedures to avoid stretching adjudication beyond their appropriate limits. Third, agencies may resist aggregation in order to insulate adjudication from renegade private attorneys general. All of these explanations arise out of perceived limits of what courts and administrative judges can do to resolve claims brought by large groups of people.

A. Congressional Legislation and Rulemaking Constitute a Form of Aggregation

The resistance of some agencies to aggregation might stem from the fact that adjudicatory agencies themselves already represent a form of aggregation. When policymakers channel cases raising similar legal and scientific issues into a specialized system, before adjudicators with expertise in the area, and resolve them according to uniform criteria, they aggregate cases in ways that resemble class actions settlements. Indeed, commentators often call class action settlements a privatized, administrative system" that compensates victims like " public administrative agencies."

Yet shifting the resolution of certain categories of cases from the Article III courts to administrative tribunals does not eliminate the common issues of law and fact that must be repeatedly resolved in case-by-case adjudication, nor the need for parties to harness expertise and adequate counsel to represent them in complex cases.

To be sure, when agencies have the authority and the ability, they can resolve common questions by other means, most prominently rulemaking. Rulemaking can resolve common issues of law or fact that arise in adjudications uniformly and definitively in a single proceeding, relieving adjudicators of the burden of repeatedly addressing the same issues in individual cases.

Nevertheless, rulemaking has not proved to be an effective tool for resolving all common issues of law or fact in agency adjudications. First, the law generally disfavors retroactive rulemaking. Therefore, it is less effective for addressing administrative backlogs or high volumes of filed claims such as those faced by OMHA or the NVICP discussed above.

Second, as the Supreme Court has observed, " problems may arise in a case which the administrative agency could not reasonably foresee, problems which must be solved despite the absence of a relevant rule." Just as legislation leaves gaps for agencies to fill with rules, rules leave gaps that agency adjudicators must fill. For example, the Social Security Administration's medical-vocation guidelines--an example of rulemaking used to address inefficiency and inconsistency in repeated fact finding concerning the same issues in SSA adjudications--does not address claimants with mental or psychiatric conditions. Similarly, the NVICP was confronted with claims that were not anticipated by the Vaccine Injury Table, but nevertheless had to be resolved. And the EEOC, which has no power to issue substantive regulations interpreting Title VII, is frequently confronted with new issues raising discrete civil rights claims by federal employers.

Third, the beneficiaries of many administrative programs most impacted by agency adjudications often have the least access to the rulemaking process. While rulemaking is often a " top-down" proceeding, initiated and managed by the agency's political leaders and influenced by organized interests with significant resources, aggregation can provide a " bottom-up" remedy, in which the individuals most impacted by adjudications play a role in crafting discrete, retrospective forms of relief. Federal employees bring previously unnoticed civil rights violations to light, persons injured by vaccines provide evidence on whether a particular vaccine causes a particular type of injury, and medical service providers highlight common problems in reimbursement

In sum, aggregating certain cases or claims within an agency, even one with rulemaking power, does not eliminate the usefulness of aggregation as a tool in certain circumstances. Even agency adjudicators may need flexibility, in the trenches, to aggregate " all the way down." In particular, agencies may prefer aggregate adjudication to rulemaking when the relief sought is (1) retroactive, (2) responds to backlogs of already filed claims, (3) involves discrete problems, and (4) where parties' concerns may not be easily heard or represented by sophisticated representatives or counsel.

B. The Law's Resistance to Aggregation in Adjudication

The fact that most agencies have not adopted aggregate procedures to manage large groups of common claims may reflect the conceptual line that the law has long drawn between the adjudication of bi-lateral disputes, on the one hand, and policymaking in response to more diffuse harm, on the other.

Lon Fuller famously defined the " essence" of adjudication as the right of affected parties to participate in the proceeding by " presenting proofs and legal arguments" to the decisionmaker. He suggested that adjudication was not well suited to handling what he described as " polycentric" problems. He was not particularly precise about what made problems polycentric. " [I]t is not merely a question of the huge number of affected parties, significant as that aspect of the thing may be." Rather, polycentric disputes might have different repercussions on different sets of parties depending on how they are resolved. He analogized to a spider web, in which

[a] pull on one strand will distribute tensions after a complicated pattern throughout the web as a whole. Doubling the original pull will, in all likelihood, not simply double each of the resulting tensions but will rather create a different complicated pattern of tensions. This would certainly occur, for example if the doubled pull caused one or more of the weaker strands to snap. This is polycentric situation because it is " many centered" -- each crossing of strands is a distinct center for distributing tensions.

Fuller cited the example of the U.S. government's regulation of prices and wages during World War II by the War Manpower Commission, the Office of Price Administration and the War Production Board.

[T]he forms of adjudication cannot encompass and take into account the complex repercussions that may result from any change in prices or wages. A rise in the price of aluminum may affect in varying degrees the demand for, and therefore the proper price of thirty kinds of steel, twenty kinds of plastics, an infinitude of woods, other metals etc. Each of these separate effects may have its own complex repercussions in the economy. In such a case it is simply impossible to afford each affected party a meaningful participation through proofs and arguments.

Fuller believed that such polycentric problems--involving many different parties with interdependent interests--were better handled outside the courts, through private bargaining or political elections. Nor did he see a solution in assigning such disputes to administrative agencies to be resolved through adjudication:

If we survey the whole field of adjudication and ask ourselves where the solution of polycentric problems by adjudication has most often been attempted, the answer is: in the field of administrative law. The instinct for giving the affected citizen his 'day in court' pulls powerfully toward casting exercises of governmental power in the mold of adjudication, however inappropriate that mode may turn out to be.

Fuller's framework turned out to be very persuasive in administrative law. Formal rulemaking under the APA, which shares many of the characteristics of adjudication, fell out of favor in the post-war period for the reasons Fuller suggested. It is neither necessary nor practical to use formal adjudicatory procedures to resolve issues that require more fluid negotiation and politically accountable policy choices. At the same time, there was a marked shift in regulatory decisionmaking from formal adjudication to informal rulemaking, with scholars and courts routinely criticizing agencies that used adjudication rather than informal rulemaking to decide policy questions. Indeed the negative view of policymaking through adjudication was so strong that the Supreme Court had to repeatedly remind the lower courts that agencies were not precluded from deciding broad policy questions in the context of adjudication.

This division is reflected in the APA itself, which provides distinct sets of rules and procedures for " adjudication" and agencies' broader policymaking powers using rulemaking and enforcement. Adjudicatory decisions are rendered after a hearing on the record conducted by ALJs insulated from agency policymakers, while policymakers using rulemaking operate in a distinct and much less procedurally constrained world. The APA does not seem to contemplate cases falling in between the formal categories of rulemaking and adjudication--such as when agency proceedings systematically affected groups of people in the same way.

Fuller's concern with judicial handling of polycentric disputes also underlies some of the criticism of the federal class action. It manifests itself in concerns over the ability of courts to adequately protect absent class members whose interests may diverge from those of the named plaintiffs before the court. In Amchem Products, Inc. v. Windsor, for example, the Court was troubled by the impact of a proposed settlement on parties who had not yet filed claims, had distinct interests, and did not have their own representatives:

[T]he interests of those within the single class are not aligned. Most saliently, for the currently injured, the critical goal is generous immediate payments. That goal tugs against the interest of exposure-only plaintiffs in ensuring an ample, inflation-protected fund for the future. ... The settling parties ... achieved a global compromise with no structural assurance of fair and adequate representation for the diverse groups and individuals affected.

One can almost hear the echo of the " pull" on Fuller's spider web in the " tugs" of Justice Ginsburg's opinion.

Although the courts' concern with adequate representation of absent class members may be less acute in the context of injunctive relief, skepticism remains over the judiciary's ability to resolve these types of polycentric disputes. Particularly when class actions attempt to reform federal government programs, the Supreme Court has exhibited discomfort with allowing courts to decide what it views as essentially political decisions. Even though scholars and judges have critiqued Fuller's analysis for failing to capture the many ways that judges actively managed and oversaw fluid forms of relief, like structural reform efforts, there is no denying that Fuller's framework has deeply influenced the way we think about when courts, Congress or private parties should resolve disputes.

The response to Fuller's concerns is often to re-direct these types of polycentric issues to the administrative state. The rationale is that agencies can more efficiently and legitimately handle these types of mass adjudicatory problems and are more politically accountable than courts and entrepreneurial plaintiffs' attorneys. Among other things, agencies are not bound by Article III " case or controversy" requirements or the Federal Rules of Evidence; can develop more expertise in specialized areas; and can rely on " notice and comment" rulemaking to resolve common issues of fact or law. For this reason in Amchem the Court suggested that " a nationwide administrative claims processing regime would provide the most secure, fair, and efficient means of compensating victims of asbestos exposure."

What our study illustrates, however, is that even as cases move from the judiciary to administrative agencies, adjudicators must continue to engage in the kind of bargaining and active case management that Fuller viewed as inconsistent with adjudication. Without the ability to consolidate and aggregate cases, rely on steering committees, subclass interest groups, and turn to statistical consultants, agency adjudicators could not efficiently hear and consistently resolve large groups of cases within already aggregated systems. Far from being inconsistent with adjudication--as the APA and legal process theorists like Lon Fuller have long posited--tools that allow judges to actively organize and manage cases have proven to be an essential part of an adjudicative process that must rely on " the presentation of proof and reasoned argument." Adjudicators may rely on such tools to encourage litigants to invest resources developing information needed to resolve the underlying dispute and resolve persistent questions in a " just, speedy, and inexpensive" manner.

Consider the NVICP, which Congress established to create a no-fault alternative for children injured by a particular vaccine. This represents a policy choice by Congress allocating costs and benefits stemming from vaccination in a polycentric system, where many bilateral disputes between injured parties and vaccine manufacturers have repercussions for public health writ large. Congress also believed that a group of specialized adjudicators could resolve difficult questions of causation more efficiently, consistently, and fairly than courts. But when confronted with an influx of claims that the same vaccine caused the same type of injury among a large group of claimants, the NVICP special masters turned to the very same tools used by the courts in mass-tort cases. The NVICP special masters created an ad hoc system to pool claims before the same adjudicator and form steering committees of claimants' counsel, who then coordinated to offer the best expert testimony they could in support of their clients' claims. Even after Congress consolidated vaccine cases before a specialized tribunal under the Vaccine Act, the tribunal could not avoid using aggregation to meaningfully resolve its own large influx of similar claims.

OMHA is coming to the same realization in the context of Medicare appeals. In 2003, Congress moved all Medicare disputes from the Social Security Administration to OMHA, another specialized tribunal with unique expertise resolve very complicated medical disputes. Now facing an " existential" test, OMHA has turned to aggregation to handle a deluge of appeals regarding similar types of claims by the same parties.

Specialized administrative courts, including the Vaccine Court, have recently come under scrutiny for failing to deliver the promised expeditious and rationalized compensation decisions. Our study similarly finds that specialization, expertise, and informal procedures may not be enough for administrative agencies and other non-Article III courts to address these concerns. In some sense, advocates may underestimate the expertise of Article III judges and overestimate the expeditiousness and informality of agency procedures. But our study suggests that just like Article III courts, when confronted with large numbers of similar cases, agencies may need to turn to aggregation to resolve similar claims consistently, rationally, and legitimately.

C. The Resistance of Policymakers to Enabling Litigation

With the possible exception of the EEOC, the turn to aggregation by the agencies we studied was motivated primarily by a desire to resolve rather than enable claims. The NVICP developed its omnibus proceedings in response to an influx of cases, not to make it easier for injured parties to file cases. OMHA was established to resolve the inevitable disputes that arise in the administration of a mass benefits program while affording beneficiaries due process. The EEOC, by contrast, turned to the class action in order to enhance the ability of plaintiffs to act as private attorneys general in furtherance of federal anti-discrimination policy. It was not responding to any type of backlog. It is noteworthy that the EEOC's administrative class action mimics the class actions brought by employees against private employers in federal court.

Indeed, other agencies that have specifically considered and rejected using aggregate adjudication have cited concerns with enabling more claims. As noted above, the FCC rejected a proposal to hear class actions in its own adjudications of alleged violations of the Federal Communications Act because, among other reasons, it would " needlessly divert" the resources of its lone ALJ to adjudicating extremely " fact-intensive and complex" cases, that can just as easily be filed in federal court. The CFTC similarly rejected the use of class actions in the adjudication of broker-dealer disputes due to fears of burdening its adjudicators as well as the availability of class actions in federal court. Finally, the Department of Education recently proposed creating an optout class action proceeding to resolve thousands of claims by student borrowers, but declined to allow private parties to aggregate themselves. Under the proposed rule, only the DoE would be able to commence the action.

This is interesting because one function of the class action is to enable claims that would otherwise not be brought in individual litigation because the damages are too small for individuals to justify the costs of litigation. Even with the money at stake in OMHA appeals and vaccine injury claims, the low value of many individual Medicare claims and the challenges to recovery faced by plaintiffs suing for vaccine injuries suggests that aggregation could have some effect as a device to enable claims that might otherwise not be brought or not succeed. Indeed, it seems even more likely that aggregation could play such a role in the contexts in which agencies have specifically rejected it, such as the types of consumer claims regulated by the FCC and CFTC.

Perhaps agencies are disinclined to use aggregation to enable litigation because agencies typically have their own enforcement powers and worry that an unaccountable private attorney general might upset an agency's carefully calibrated enforcement regime. The Court has recognized that state enforcers can undermine federal enforcers. Perhaps agencies avoid promoting private litigation for the same reason.

This seems inconsistent with the way that many agencies have recently touted class actions in federal court--a private complement to otherwise overburdened, government actors unable to respond to fraudulent investment schemes, unconscionable consumer contracts, and predatory for-profit colleges. And certainly, in many cases, aggregate agency adjudication represents less of a threat to control of enforcement by federal authorities than private class actions in federal court. Unlike in federal court, the agency's political appointees typically have final decisionmaking authority in the cases adjudicated by ALJs and other agency adjudicators. The agency head may interpret the law without regard to the decision below and may even overturn the ALJ's findings of fact under certain circumstances. This should enable agencies to block plaintiffs from successfully advancing overly innovative legal theories.

Yet again, an agency might dispute " the notion that all laws warrant enforcement to the letter in all instances." An agency's formidable control over a proceeding may not be enough to prevent plaintiffs from bringing what are in fact meritorious claims, but which agency enforcers nevertheless judge as unnecessary and possibly even counter-productive. As Richard Nagareda once observed, " the question here is: [I]f the function of the class action today is indeed to operate in parallel with public regulation, then can that function achieve fruition without supplanting the institutional boundaries on regulatory power?"

We do not take a position on whether agencies should make greater use of aggregation as a tool to complement their own enforcement regimes with private attorney generals. But, agency resistance to using private attorney generals in their adjudicatory proceedings may underscore the power of aggregation as an enforcement mechanism. Just as scholars have long examined the rise of " private attorney generals" in our federal and state courts, the use of private attorneys general in agency adjudications is an issue that bears examination. Federal agencies have only begun to explore the forms and limits of aggregation in their adjudicatory proceedings.

Conclusion

Moving cases involving large groups of people to administrative agencies does not solve the risks inherent in individual adjudication of such cases: long backlogs, inconsistent results, and obstacles to justice for those without access to legal and technical expertise. But agencies have shown they can respond to such problems by using their existing authority to aggregate cases themselves--with proper attention to avoiding diseconomies of scale and ensuring the legitimacy and accuracy of their decisions.

More broadly, aggregate agency adjudication raises broader questions about the way we think about the nature of adjudication. Rather than building formal walls between policymaking and adjudication to make adjudication legitimate--which we have done in both class action law and within the administrative state--some judicial proceedings require integrating rulemaking and other managerial tools to ensure the legitimacy of adjudication itself. The central question raised by such cases turns not on any abstract concept of adjudication or policymaking, but instead, how to best adapt procedure to " fairly insure[] the protection of the interests" at stake.

A class action may be maintained if Rule 23(a) is satisfied and if: (1) prosecuting separate actions by or against individual class members would create a risk of: (A) inconsistent or varying adjudications with respect to individual class members that would establish incompatible standards of conduct for the party opposing the class; or

(B) adjudications with respect to individual class members that, as a practical matter, would be dispositive of the interests of the other members not parties to the individual adjudications or would substantially impair or impede their ability to protect their interests; (2) the party opposing the class has acted or refused to act on grounds that apply generally to the class, so that final injunctive relief or corresponding declaratory relief is appropriate respecting the class as a whole; or (3) the court finds that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy.

1. They have at least 250 claims on appeal, all of which fall into only one of the following categories: (i) pre-payment claim denials; (ii) post-payment (overpayment) non-RAC claim denials; or (iii) post-payment (overpayment) RAC claim denials from one RAC. 2. The claims must be currently assigned to an ALJ or filed between April 1, 2013 and June 30, 2013, but no hearing on the claims has been scheduled or conducted. 3. The appellant must be a single Medicare provider or supplier, but providers or suppliers with multiple National Provider Identifiers (NPIs) owned by a single entity may proceed under one provider number by agreement of the appellant's corporate office. 4. There can be no outstanding request for Settlement Conference Facilitation for the same claims.

1. groups of at least 20 appeals or appeals comprising $10,000 in aggregate claims; 2. filed by a Part B provider or supplier in 2013; 3. under the same NPI; 4. that have not yet been assigned to an ALJ for a hearing; and 5. are not the subject of an outstanding request for statistical sampling.