Year after year, federal spending on poverty programs has been going up, but we still see more and more people who have no margin to guard against unexpected expenses or job loss. At the same time, for different reasons, Americans who are not impoverished have seen their wealth decline sharply. Expert Ron Haskins, co-director of the Center on Children and Families, says the problems are growing deeper, despite increased federal spending on programs to assist the poor. Haskins says everyone must sacrifice, but also says, that people in general, who finish high school, get a job, and get married and delay having children until age 21 are better off.

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• Solutions to Poverty's Rise in America

There are now more than 335 Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP) in 47 states, DC, and Puerto Rico. Early results show that most Medicare ACOs are succeeding at meeting their quality benchmarks, but only about a quarter of MSSP participants have been able to reduce their spending enough below projected financial targets to qualify for shared savings. While these results are encouraging, especially given the financial and practice transformation necessary to succeed as an ACO, they also suggest that more work is needed from both CMS and the providers to ensure continued sustainability of the MSSP ACOs.

Given that the first three year cycle of MSSP ends in 2015 and more providers will likely be entering the MSSP in the coming years , the Centers for Medicare and Medicaid Services (CMS) has indicated that they intend to release a Notice of Proposed Rulemaking (NPRM) that will establish the rule for participation in the Medicare ACO program. In anticipation of these coming changes, the Engelberg Center for Health Care Reform released an issue brief that identifies the "Top Eight ACO Challenges" to encourage further discussion and considerations for ensuring the continued success of ACOs. These potential policy alternatives build on discussions with ACO Learning Network members and other related stakeholders implementing accountable care across the country and include the following issues.

These issues, and many others, will be a focus of the discussions at the upcoming Fifth National ACO Summit later this week.

Top Eight Medicare ACO Challenges

1. Make Technical Adjustments to Benchmarks and Payments
In order for ACOs to qualify for shared savings, they must be able to hold spending below a financial benchmark set using historical spending patterns and meet a certain threshold of person and population-level quality metrics. A number of issues should be considered that affect the ACO’s chances of being able to attain shared savings and have more predictability about their performance: benchmark calculation methodology, how to adjust for regional variation in performance, and risk adjustment.

2. Transition to More Person-Based Payments
The ultimate goal of an ACO is to improve quality at the patient and population level and control the growth of health care costs. In order to successfully achieve this mission, ACOs must over time make a transition to payments that involve the assumption of more risk by the provider organization with a reward for better health outcomes for groups of patients. ACOs must have a clear transition path for increasing accountability and assumption of more risk for patient health outcomes.

3. Increase Beneficiary Engagement
Patients can play a critical role in helping to achieve the goals of an ACO. Health outcomes are determined by whether patients follow prescribed therapies. Increasing beneficiary engagement holds the potential to make patients more activated members of the ACO who can contribute to its success. A number of issues should be considered to improve beneficiary engagement, including adjusting attribution methods, creating more incentives for patients to seek care within the ACO, and finding opportunities to activate patients as part of the care team.

4. Enhance and Improve Alignment of Performance Measures
A central tenet of Medicare ACOs is delivering high quality health care as determined by performance on 33 measures established by CMS. ACOs must meet performance benchmarks in order to be eligible for shared savings, ensuring that these organizations are delivering high value, rather than simply cheaper, care. A number of barriers exist to achieving better performance measurement, including administrative burdens, lack of measure alignment among payers, lack of rewards for quality improvement, and concerns about measure selection.

5. Enable Better and More Consistent Supporting Data
In order to succeed as an ACO, organizations must be able to effectively collect, interpret, and use clinical and claims data to transform care of their patients. ACOs need to adopt new health IT systems and other technologies in order to collect and use the growing amount of data. ACOs currently struggle with reconciling data between different sources, dealing with patients who opt out of data sharing, lack of timeliness for receiving data, difficulty of tracking patients through the health system, and delays in performance feedback.

6. Link to Additional Value-Based Payment Reforms
ACOs are just one of many payment reforms that health care organizations across the country are implementing to improve quality and reduce costs. Aligning the vision and components of these other initiatives with ACO reforms has the potential to reinforce the shared goals and fundamentally change the health system. However, there are barriers to achieving this alignment such as lacks of linkages to bundled payments and other new payment models, multi-payer ACOs with different payment systems, and inability for organizations to participate in multiple CMS payment innovations.

7. Develop Bonus Payments and Other Incentives to Participate
In order to effectively transform clinical practice, ACOs must create or procure significant financial and human capital, as well as transform their information technology and delivery infrastructure. A recent survey estimates the average start-up cost for creating an ACO to be $2 million, with some ACOs investing significantly more in their first few years. Many ACOs, especially smaller ones, struggle to find sufficient start-up capital, are uncertain if they can assume the level of risk required for an ACO, and need significant staff and clinical change to effectively transform care.

8. Support Clinical Transformation
Becoming and succeeding as an ACO is a vast undertaking that requires immediately beginning to transform practice, finance, and operations. However, many providers, particularly those that are less experienced at systemic practice transformation, need more support in undertaking clinical transformation.

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• Issue Brief: Improving the Medicare ACO Program

Contributors: Alice M. Rivlin and Christine Dang-Vu

Recent data suggest that Accountable Care Organizations (ACOs) are improving important aspects of care and some are achieving early cost savings, but there is a long way to go. Not all ACOs will be successful at meeting the quality and cost aims of accountable care. The private sector has to date allowed more flexibility in terms of varying risk arrangements—there are now over 250 accountable care arrangements with private payers in all parts of the country—with notable success in some cases, particularly in ACOs that have been able to move farther away from fee-for-service payments. Future growth of the Medicare ACO program will depend on providers having the incentives to become an ACO and the flexibility to assume different levels of risk, ranging from exclusively upside arrangements to partial or fully capitated payment models.

Given that the first three year cycle of Medicare ACOs ends in 2015 and more providers will be entering accountable care in the coming years, the Centers for Medicare and Medicaid Services (CMS) has indicated that they intend to release a Notice of Proposed Rulemaking (NPRM) affecting the Medicare ACO program.

In anticipation of these coming changes, the Engelberg Center for Health Care Reform has identified the "Top Eight ACO Challenges" that warrant further discussion and considerations for ensuring the continued success of ACOs across the country. To support that discussion, we also present some potential alternatives to current Medicare policies that address these concerns. These findings build on the experiences of the Engelberg Center’s ACO Learning Network members and other stakeholders implementing accountable care across the country.  In some cases, the alternatives might have short-term costs, but could also improve the predictability and feasibility of Medicare ACOs, potentially leading to bigger impacts on improving care and reducing costs over time.  In other cases, the alternatives could lead to more savings even in the short term. In every case, thoughtful discussion and debate about these issues will help lead to a more effective Medicare ACO program.

Top Eight ACO Challenges

1. Make technical adjustments to benchmarks and payments
2. Transition to more person-based payments
3. Increase beneficiary engagement
4. Enhance and improve alignment of performance measures
5. Enable better and more consistent supporting data
6. Link to additional value-based payment reforms
7. Develop bonus payments and other incentives to participate
8. Support clinical transformation

Downloads

• Issue Brief: Improving the Medicare ACO Program

Please note that this Engelberg Center for Health Care Reform Health Policy Issue Brief first appeared in the Health Affairs Blog on July 31, 2014. Click here for the Health Affairs Blog version.

Abstract

Individual patient expanded access is a process by which patients can obtain investigational drugs that have not been approved by the Food and Drug Administration (FDA) outside of a clinical trial setting from biopharmaceutical companies when no other alternative therapy is available. Currently, no industry-wide structural principles exist to help companies navigate this process while balancing the needs of getting a drug to the market as quickly as possible with providing potentially life-saving treatment to individual patients. The Engelberg Center convened a stakeholder group to identify common themes and identify common principles related to expanded access, as none currently exist. The result was 4 A’s - Anticipation, Accessibility, Accountability, and Analysis – to help assist patients, providers, and companies with expanded access. Process and capacity building recommendations for the FDA also were proposed to assist companies with sustaining expanded access programs.

Call to Action: The Importance of Expanded Access Programs

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer. Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage. Such cases included 7-year-old Josh Hardy (brincidofovir from Chimerix for disseminated adenovirus infection), 45-year-old Andrea Sloan (BMN673 from BioMarin for ovarian cancer), 41-year-old Nick Auden (pembrolizumab from Merck for melanoma), and 6-year-old Jack Fowler (intrathecal idursulfase from Shire for Hunter Syndrome). Expanded access requests to the FDA for new patients are increasing, from 1,000 patients nationwide in 2010 to more than 1,200 in 2012.[i] (This is likely an underestimate, since it does not include appeals made directly to companies.)

In the wake of these events, it became clear that many biopharmaceutical companies had varying experiences and policies related to such access. From the domestic regulatory standpoint, the FDA revised its expanded access regulations in 2009, which define criteria that must be met to authorize expanded access, list requirements for expanded access submissions, describe safeguards that will protect patients, and preserve the ability to develop meaningful data about the use of the drug. Biopharmaceutical companies typically face a complex global environment in which legal and regulatory frameworks can differ substantially. At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. Still, the public belief persists that the FDA is the main bottleneck that restricts access. In April 2014, Representative Morgan Griffith (R-VA) proposed H.R. 4475, The Compassionate Freedom of Choice Act of 2014, designed to restrict the FDA’s ability to prevent the use of investigational drugs in terminally ill patients. Similarly, some states have passed “Right to Try” legislation to reduce FDA oversight, but contains no requirement that companies must make drugs available.[ii]

The goal of our meeting was to identify common themes and possibly broad outlines to suggest industry-wide policies related to expanded access, as none currently exist. The group first discussed background issues related to expanded access and agreed on definitions. The meeting then focused on three topics. First, the group participants who play key roles in evaluating expanded access requests were invited to share narrative experiences in specific clinical cases, in an effort to lay the groundwork for trust and open discussion. Second, the group was asked to identify internal industry-specific structural barriers, such as the existence of clear procedures or tracking mechanisms within companies to handle requests. Finally, the participants reflected on situations in which expanded access may not be appropriate, or where regulatory barriers or liability concerns may hinder expanded access. This paper reflects the authors’ observations and assessment of the internal and external landscape, based upon information provided by the meeting participants.

Laying the Groundwork with Shared Experiences

The FDA allows companies to provide drugs and charge individual patients that do not meet the enrollment criteria for clinical trials geared towards regulatory approval through expanded access programs.[iii] These programs are meant to provide the drug directly to treat the patient’s condition, rather than having the primary goal of collecting efficacy or detailed safety data in support of approval. Before 1987, the FDA lacked formal recognition of expanded access, although investigational drugs were provided informally.[iv] Since then, the FDA has instituted novel classes of individual INDs so that a company sponsor or licensed physician can legally obtain treatment access from the FDA to provide a drug while it is still in the approval process.[v] Essentially, this provides companies a legal exception from the law to ship unapproved drugs across state lines, and if they desire, to charge for them. These INDs are designed solely for the potential benefit of desperate patients and not intended to formally collect safety or efficacy data that could potentially inform a regulatory decision, but can have regulatory impact, nonetheless.

At the outset, several participants objected to the term “compassionate use,” since it introduces inherent value decisions, can emotionally charge discussions, and does not recognize that there may be valid and ethically appropriate reasons for denial. The generally agreed upon term “expanded access,” is used throughout this paper. (One participant suggested the term “early access.”) Ideally, the term would make it obvious that this is access to an unapproved drug, in order to temper expectations of favorable results. Somewhat confusingly, the FDA uses the terms “expanded access,” “access,” and “treatment use” interchangeably to refer to the use of a drug, and of which none clearly identify the stage of development.[vi]

Participants shared numerous examples of requests for expanded access and explained that their companies handle anywhere from a handful to several hundred requests per year. The following selected stories illustrate the wide range of experiences and situations that companies encounter when navigating the complex decisions involved in administering an expanded access program. Several other examples were discussed and the specific participants expressed that they would be willing to share these particular examples publicly.

Chimerix, a 54-employee company based in Durham, North Carolina, is developing the drug brincidofovir and previously had created an intermediate expanded access protocol for the drug (CMX001-350) as encouraged by the FDA following over 200 emergency INDs granted for access to brincidofovir.[vii] One such case was for an armed services member with previously undiagnosed acute myelogenous leukemia who developed life-threatening vaccinia infection following smallpox vaccination in 2009.[viii] The patient received the drug from Chimerix through an emergency IND. After two years, the company had not secured FDA approval for the drug and eliminated expanded access in February 2012 in order to focus on studies which would inform a regulatory decision. In March 2014, Chimerix originally rejected an emergency IND request for 7-year old, Josh Hardy, who was critically ill from disseminated adenovirus infection after bone marrow transplantation. A highly public social media campaign targeted the company in the wake of this decision, and the experience was traumatizing for many of the employees. Following discussion with the FDA, Chimerix initiated a new clinical trial for the treatment of adenovirus infection in order to collect safety and efficacy data to support an NDA submission. Hardy was the first patient enrolled in the clinical trial, and his family reported through several media outlets that he recovered from the adenovirus infection and was discharged home.

One biopharmaceutical company representative described receiving a middle-of-the-night telephone call directly at home, with an emergent, time-sensitive request for an experimental therapy for a critically ill child with a rare acute disease in a foreign pediatric intensive care unit, where regulatory standards were different from those in the U.S. The ideal pediatric dosage was unknown, and only limited safety data and clinical details were available. Urgent efforts were made to gather more information and the request was approved, but despite these efforts the patient did not survive.

Bristol-Myers Squibb began a clinical trial for a cancer drug several years ago.[ix] A woman with pancreatic cancer enrolled in the trial and saw that her tumor was no longer growing. After the 3.5 year trial, the study closed because the drug was deemed ineffective for all other patients and was not approved for further development. However, the company continued to provide the drug for the one woman for whom the drug was effective through a single patient IND for an additional 9 years.

To demonstrate the volume of expanded access requests, one participant showed several messages on his mobile device during the half-day discussion, directly from patients who had located his email addresses through on-line searches, to plead for expanded access to an anticancer therapy.

Development of Structural Principles: The Four A's 

Broadly, no specific industry-wide consensus on expanded access procedures exists. As a result, there is significant variation in company policies and procedures. During this phase of discussion, participants shared their own company strategies and suggested possible areas of consensus that might form the basis for shared principles and industry-wide practices. These suggestions fell into four categories, which we termed the 4 “A’s”: Anticipation, Accessibility, Accountability, and Analysis (see Figure 1).

First, the group agreed that large and small companies should anticipate the need for and creation of expanded access programs when developing drugs expected to generate expanded access requests and as part of the drug development plan. This is particularly important for drugs that might be considered for priority or breakthrough designation during FDA approval. In these cases, companies should strongly consider developing a written expanded use policy with clear guidelines for inclusion and exclusion, which would also feature a defined review process, clear decision making criteria, and a defined time frame for response to requests. This also allows companies to plan for the demands that may be placed on their supply chain and staff resources to ensure sufficient supply for investigational and expanded use purposes. Identifying a decision maker within each company and for each disease area/product will also help patients or physicians reach the appropriate contact when requesting a drug, as well as assist the company in gaining expertise in responding to these requests. For example, one large company identifies one point of contact for all expanded access requests regarding each product and posts that individual’s contact information on the website.

In the early stages of drug development, supplies of investigational drugs are extremely limited. This is often because the technically-challenging process of optimizing drug product manufacture takes a considerable amount of time. Low yielding manufacture batches are not uncommon at the early phases of research. Some companies do not approve expanded access requests because they do not have enough of the drug in stock to supply these external requests and meet the needs of investigational study patients and individuals participating in clinical trials, an issue which may be particularly acute for biologics. Smaller companies may have more resource constraints, such as inadequate staff to manage requests or supply chain and logistics issues. One representative suggested that if a company had early transparency from regulators about the final numbers of subjects they would be willing to accept to achieve drug development milestones, it would make it much easier for the company to feel less reservation about its drug supply. (It may be beneficial for companies to analyze their financial ability to provide drugs potentially at no cost or when there is not a large enough supply, ideally in a transparent manner.)

Once an expanded access policy is anticipated and developed, the second key principle the group identified was making the policy accessible to all individuals who may qualify. First, for patients, with guidance from their treating physician, the company making the drug should always steer the patient to enter a clinical trial (if they meet eligibility criteria). If the contacted company cannot accommodate the patient, they should steer them to other open trials if possible, even if sponsored by another company. Many of our participants noted that this already occurs.

The group was particularly cognizant of the disparity in access to drug companies and their expanded access programs: patients with savvy social media strategies are more likely to succeed in navigating across organizational constraints than without similar sophistication. The group believes that increased accessibility would assist in making opportunities for expanded access more equitable. In addition, these policies could help educate patients and physicians about submitting legitimate expanded access requests and help decrease the costs of reviewing inappropriate requests on the company (for example, if there are other proven therapies or the situation is not life threatening).

If the patient is ineligible for a trial, the patient should be able to easily access the written expanded access policy online. For example, both large and small companies like Pfizer, Bristol-Myers Squibb, Shire, and Merck post their expanded access policies on their websites, though the terminology may in some cases be complex. In addition, Janssen has developed a video explaining their policies in non-technical terms. Ideally, such policies should be available in some web based or public facing platform to both patients and physicians and written in a clear manner that is jargon free and accessible to individuals at various education levels. Most participants felt strongly that requests for expanded access should originate from a medical provider, not from a patient, since expertise is needed to first screen appropriate candidates. This is consistent with current FDA regulations for an IND, in which a physician or qualified medical expert must sponsor an IND or serve as an investigator under an existing IND for expanded access.

Third, companies should have accountability to the requesting party for expanded use requests that they receive and review them within a specified, transparent amount of time. If the request could not be approved, the company should consider clear communication and provide an explanation of why the request was turned down. In these cases, some participants suggested that the company might also consider instituting an appeals process by which a patient can receive an additional review if not approved, potentially from a non-binding third party such as an independent, multidisciplinary body or a regulatory agency like the FDA. (Two participants, however, were uncomfortable with any third party review.)

The final principle would encourage companies to release timely analysis of data from expanded access patients. In addition to tracking communication, companies should keep a database of the number of requests and outcomes, in a manner that doesn’t slow getting drugs to needy patients rapidly. One company refined its internal tracking tools to determine who was requesting drugs, for what conditions, and where they lived. Where possible, companies might be encouraged to share anecdotal or preliminary safety or efficacy data from expanded access in peer-reviewed or other refereed venues in a prudent time frame following collections, if this is available or known. This is not always possible, because emergency INDs do not require provision of safety or outcome data to the company.

There are several challenges associated with operationalizing this in the current model, namely the appropriateness of anecdotal data, the level of detailed safety and efficacy data currently available through expanded access, suitability for publication, and funding for these activities in the current budget climate. One potential approach to address this is funding from federal or state regulatory agencies or payers for the reasonable costs of follow-up and reporting outcomes.

Regulatory Considerations

The participants then discussed the types of risks, including regulatory and financial, that may affect companies’ expanded access policies. When a company is considering expanded access requests, they consider the risks-benefits of providing the drug outside of a clinical trial as well as the potential for any regulatory issues in an era of litigation and an increased threshold for demonstration of safety. While a company’s provision of a drug for expanded access is voluntary, the FDA does require the company to collect and report safety data. Notably, none of the representatives felt that the FDA is a major regulatory barrier to processing and approving expanded access requests once the sponsor has reviewed the request, assessed the benefit-risk, and determined the request meets FDA requirements and evidentiary standards. In addition, the attendees felt that adverse effects and related liability risk were not of particular concern given that the drugs are assessed on a risk-benefit analysis.

However, companies that make drugs in particularly limited markets with small numbers of patients (for example, for unusual diseases with less than 200,000 patients nationwide which may justify a special designation called “orphan status”) may be more concerned about restrictive labeling if an unusual adverse event occurred even in one or two patients during expanded access of an orphan or small market therapy. However, there is no data of which participants were aware and no public reports that an adverse event during expanded access has harmed regulatory approval.[x] The group opinion was that that safety data would be available eventually in any event and an FDA “safe harbor” provision would not necessarily affect companies’ willingness to accept more requests for expanded access. A final concern was that there is no regulatory mechanism to consider data from expanded access in the evidence generation process for approval.

An Expanded Role for the FDA

While the FDA may not serve as a strong barrier to expanded access, the group considered strategies to promote equitable and fair access. For example, some argued that the breakthrough or priority review categories for FDA review might identify products that could have high potential for expanded access requests. This designation expedites “the development and review of drugs for serious or life-threatening conditions.”[xi] As of mid-April 2014, the FDA had received nearly 180 requests for breakthrough designation, with 44 requests granted.[xii] By hastening the drug development process, the FDA has already begun to bring drugs that have a reasonable expectation of benefit to the market faster. In order to receive breakthrough therapy designation, current legislation might be amended so companies could be asked to provide evidence that the 4 A’s are being followed in some capacity.

The FDA might also assist companies in establishing expanded access programs during open clinical trials in two main areas: process and capacity building. First, in terms of process, the FDA could be asked to create a defined path for regulatory approval with provisions that would encourage companies, both large and small, to include plans for expanded access programs when developing a drug. While FDA’s draft guidance related to INDs notes that larger expanded access programs could threaten enrollment in clinical trials,[xiii] and some participants agreed that this was a significant issue, not all companies have had difficulties enrolling patients in both clinical trials and expanded access programs. For example, one large pharmaceutical company left a Phase 1 clinical trial open for a promising therapy while concurrently enrolling individuals who didn’t qualify for open clinical trials into an expanded access program, without appreciable leakage of enrollees in their advanced phase trials that might affect the key development pathway.

Second, the FDA could support convening around capacity building and sharing best practices with companies. With the understanding that there are many small biotechnology or pharmaceutical companies with limited budgets and staff, the FDA could foster a partnership of large and small companies. This partnership could be achieved by convening meetings where companies share their experiences in creating and sustaining expanded access programs. This could be supported by creating a database for these shared ideas, as well as any expanded access data that can be made legally available, such as how many requests are granted or patient outcomes.

To ensure equitable, consistent, and transparent review of requests, some companies suggested the use of an impartial external advisory board. Similar to an unbiased review from an institutional review board (IRB), this committee could have an advisory or decision making function. Companies with supply constraints may feel that if they cannot give the drug to everyone who requests it, then they should give it to no one. This committee could help the company triage the patients who would benefit the most, and would be protected from liability.

Next Steps

The most efficient and equitable way to make new effective treatments to the largest number of needy patients is regulatory approval, accelerated or otherwise, following successful demonstration of efficacy and safety for a given indication in a specific population. Until that process is complete, access to an experimental therapy is by definition an additional risk, as the agreed necessary safety and efficacy have not yet been demonstrated. True informed consent in this setting is difficult to obtain (i.e. studies have shown that severely ill patients, such as those with life-threating circumstances requesting expanded access, had less retention of information discussed in the informed-consent process and less-clear understanding of the risks of therapy compared to healthier patients[xiv]).

One position companies and regulators can consider is that the default answer to expanded access requests should be affirmative, unless there are compelling reasons for not approving requests to patients with life-threatening illnesses. (Such reasons, for example, might include limited treatment supply or lack of reasonable expectation of benefits versus risks.) Such a position would require, however, that there be broader industry, clinician, regulatory, and patient advocacy agreement of shared principles. This paper outlines the experiences, structural principles, and regulatory considerations of a small group, but further meetings may convene a broader group of stakeholders to build upon these concepts. Such consensus-based approaches might lead to durable systems that meet the needs of desperate patients who have run out of options—while allowing innovation to continue to benefit those who may come afterwards.

Acknowledgements: We are grateful for the participation of the following representatives in the roundtable: Jeff Allen (Friends of Cancer Research), Michelle Berrey (Chimerix), Renzo Canetta (Bristol-Myers Squibb), Anne Cropp (Pfizer), Joseph Eid (Merck), Aaron Kesselheim (Harvard Medical School), Howard Mayer (Shire), Jeffrey Murray (FDA), Lilli Petruzzelli (Novartis), Amrit Ray (Janssen), and Robert Truog (Harvard Medical School). We thank Mark McClellan (Brookings Institution) for helpful discussions of this topic and comments on the manuscript, and to the Richard Merkin Foundation for support. The views and opinions expressed in this article were interpreted and organized by the staff of the Brookings Institution. They do not necessarily reflect the official policy or position of any individual roundtable representative, their companies, or their employers.

References

Downloads

• The Four A's of Expanded Patient Access

The Centers for Medicare and Medicaid Services (CMS) recently reported more optimistic news about the Medicare Accountable Care (ACO) Program, which began in 2012.  CMS released final first year financial and quality results for the Medicare Shared Savings Program (MSSP) ACOs and preliminary year two financial and quality results for the Pioneer ACO Model (Pioneer ACOs).

Financial Results: To date, the two programs have generated savings of $817 million—$372 million of which has been saved by Medicare and another $445 that has been returned to the ACOs through shared savings. While these savings are not final calculations, they suggest that both programs have produced modest savings in the first two years with some variability across ACOs.

Pioneer ACOs: Pioneers, generally considered more advanced ACOs, were able to generate more total program savings in year two than in year one ($96 million vs. $87 million), while also qualifying for shared savings payments of $68 million. The Medicare Trust Fund saved approximately $41 million in year two of the Pioneer program. In total, Pioneer ACOs were able to achieve an approximately 1% lower spending trend overall for the Medicare population than fee-for-service (1.4 vs. 0.45 percent lower per capita growth). Seventeen of the 23 Pioneer ACOs had positive or neutral financial performance, eleven of which were able to slow health spending enough to share in savings. On average, those ACOs saved $4.2 million in 2013, up from $2.7 million in 2012; shared savings grew from $1.2 million to $13 million. Six Pioneers generated losses, three of which were significant enough to require those Pioneer ACOs to share in the losses. While remaining Pioneers have been able to attain bigger savings in year two of the program, almost a third of original participants have left the program—some have moved to the lower risk MSSP, while others have focused on commercial ACO contracts or higher levels of risk in MA programs.

MSSP ACOs: MSSP ACOs were likewise able to reduce overall cost trend by slightly less than 1 percent. Of the 220 MSSP ACOs that started in 2012 or 2013, roughly one-quarter (53) were able to reduce spending enough to qualify for total shared savings of over $300 million. An additional 52 ACOs reduced spending compared to their benchmarks, but not enough to qualify for shared savings. One ACO that opted for track two (two-sided financial risk) overspent its benchmark by $10 million and owed shared savings of $4 million. MSSP ACOs as a whole were able to reduce spending by $652 million below their financial benchmarks and saved the Medicare Trust Fund $345 million, including repayment for the track 2 ACO losses.

Quality Results
Medicare ACOs continue to improve significantly on overall quality scores.  Both Pioneer ACOs and MSSPs have been able to attain higher average performance than quality benchmarks and better performance than Medicare fee-for-service on measures with data, such as colorectal screening, tobacco cessation, and depression screening.

Pioneer ACOs: All 23 Pioneer ACOs that remain in the program out of the initial 32 successfully reported their quality measures in their first two years.  The mean quality scores for Pioneer ACOs increased by 19 percent, from 71.8 percent in 2012 to 85.2% in 2013. Pioneer ACOs increased average improvement by 14.8 percent across all quality measures and overall improvement on 28 of 33 quality measures. Patients also report a positive experience receiving care from Pioneer ACOs—the ACOs improved average performance scores for patient and caregiver experience across 6 out of 7 measures.

MSSP ACOs: MSSP ACOs, as a group, posted even more improvement in quality scores than the Pioneer ACOs. MSSP ACOs starting in 2012 and 2013 were able to improve 30 of 33 quality measures, including measures such as patients’ rating of clinicians’ communication, beneficiaries rating of doctors, health promotion and education, screening for tobacco use and cessation, and screening for high blood pressure. In total, MSSP ACOs are experiencing higher CAHPS patient experience survey scores than Medicare fee-for-service, suggesting that patients are engaged and satisfied with being a part of an ACO. Additionally, MSSP ACOs achieved higher average performance rates on 17 of 22 Group Practice Reporting Option (GPRO) Web Interface measures reported by other large physician group fee-for-service providers.  Over 125,000 eligible providers or supplier members of ACOs qualified for incentive payments through PQRS (Physician Quality Reporting System) in 2013. Unfortunately, nine MSSP ACOs failed to successfully report their quality scores, four of which would have otherwise qualified for shared savings.

Digging Deeper into the Results
While program level analysis of financial performance is meaningful, a deeper analysis of the data and organizational characteristics of those MSSP ACOs that earned shared savings reveals some interesting trends. A little over half of those earning shared savings were physician-led ACOs (26/49) and more than a third of these physician led ACOs operate in Florida (10/26). The continued success of physician-led ACOs is consistent with previous findings that these ACOs may be better positioned than institutionally-based ACO to reduce overall costs. In addition, analysis by The Center for Medicare and Medicaid Innovation (CMMI) found that there is no relationship between savings/loss performances and whether the ACO included a hospital. Hospital-led ACOs were overall less likely to share in savings than physician-led ACOs. These two findings together suggest that ACOs can experience success even without an official hospital affiliation, paving the way for more physician practices to join and excel at accountable care.

Interesting regional trends are beginning to emerge from the data. Florida and Texas had the highest concentration of ACOs sharing in savings. Of the 30 Florida-based MSSP ACOs, more than a third (11) were able to share in savings, while almost half (7/15) Texas-based MSSP ACOs qualified for shared savings. Furthermore, the top two earning MSSP ACOs were from Texas (Memorial Herman with $28.34 million) and Florida (Palm Beach ACO with $19.34 million), respectively. The concentration of shared savings in these two states raises important questions about what is driving the high level performance. Are these MSSPs more likely to succeed because of a higher financial benchmark based on disproportionately greater regional Medicare spending? Do these ACOs have a leg up from the start because of their patient population and historical spending trend? Are physician ACOs more likely to form and succeed in these higher-cost areas? The success of these programs should not be understated, but further analysis may be needed to better understand performance drivers so appropriate program adjustments may be considered to level the playing field among MSSP ACOs across all regions.

Next Steps
While these latest Medicare ACO results are encouraging, more work needs to be done. The Pioneer Program recently lost its tenth program participant, Sharp Healthcare, bringing the total number of Pioneers down to 22. Like some other Pioneers that have exited the program, Sharp was dissatisfied with the benchmark and payment methodology and was no longer willing to assume financial risk that they felt was too great. This is just one among many policy and implementation issues with which Medicare ACOs are struggling. In June, we published a set of recommendations to ensure the long-term sustainability of the Medicare ACO program by addressing eight major ACO challenges. These results seem to reinforce the need for several of these recommendations for change in the Medicare ACO Program.

CMMI, which administers the Pioneer ACO Program, has recognized some of these challenges and has begun giving ACOs some greater flexibility in operating within the program. These changes include allowing them to move to population-based payments, waiving the 3-day hospitalization rule to allow ACOs to directly admit qualified patients to skilled nursing facilities, and experimenting with “voluntary alignment” to allow beneficiaries to attest to a primary care physician to offset some of the limitations of the existing attribution process. These are moves in the right direction; however CMS must continue to engage providers across the country to make sure the program remains viable.

Meanwhile, the MSSP will add another round of participants in January 2015 and CMS is expected to release a notice of proposed rulemaking that will amend the current operating requirements for the MSSP program later this year. The scope and nature of changes could dramatically impact the interest of new organization, as well as the continued participation of current MSSP and Pioneer ACOs.  Medicare ACOs will likely be encouraged to continue innovating to improve quality and reduce costs in the Medicare program, but the Medicare ACO program must continue to evolve to meet provider and beneficiary needs to ensure continued success.

Note: This blog has been corrected since its original posting on September 22 to reflect more accurate data.

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In our latest 21st Century Capitalism initiative paper, "What must corporate directors do? Maximizing shareholder value versus creating value through team production," author Margaret M. Blair explores how the share value maximization norm (or the “short-termism” malady) came to dominate, why it is wrong, and why the “team production” approach provides a better basis for governing corporations over the long term.

Blair reviews the legal and economic theories behind the share-value maximization norm, and then lays out a theory of corporate law building on the economics of team production. Blair demonstrates how the team production theory recognizes that creating wealth for society as a whole requires recognizing the importance of all of the participants in a corporate enterprise, and making sure that all share in the expanding pie so that they continue to collaborate to create wealth.

Arguing that the corporate form itself helps solve the team production problem, Blair details five features which distinguish corporations from other organizational forms:

1. Legal personality
2. Limited liability
3. Transferable shares
4. Management under a Board of Directors
5. Indefinite existence

Blair concludes that these five characteristics are all problematic from a principal-agent point of view where shareholders are principals. However, the team production theory makes sense out of these arrangements. This theory provides a rationale for the role of corporate directors consistent with the role that boards of directors historically understood themselves to play: balancing competing interests so the whole organization stays productive.

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Now that that the initial revelations regarding the VW scandal have sunk in it’s time to begin assessing the larger significance of those revelations. While the case and, we predict, VW, will continue for years (we are only at the end of the beginning, and far from the beginning of the end), we are far enough along to see five large questions emerging. These questions will tell us much about the economic, corporate and cultural future of VW and German enterprise. 

1) VW was an integral component of Germany's industrial reputation in Europe, across the Atlantic in the United States, and around the world. Now, that hard-won reputation is at risk. How broad will the damage be to German businesses' reputation not just for quality, but for "premium quality?"

2) Turning from the German business sector to the German economy as a whole, the VW scandal has many ironies, not least of which is that the company was a key driver (so to speak) of the famous German Wirthschaftswunder. Economic health propelled a vanquished Germany to the forefront of Europe’s post-WWII recovery and then made post-Cold War reunification a success. Does the VW scandal have the potential to slow down the overall growth of the German economy, and what are the European and global implications of that at a time when the Chinese economy is also sputtering?

3) From a corporate governance perspective, the scandal represents some of the most boneheaded thinking ever. Following disclosure of the fraud, €14bn (£10bn; $15.6bn) was wiped off VW's stock market value. Whoever knew/orchestrated the scheme thought they would get away with it, but did they really not foresee the consequences or even the likelihood of getting caught? We will long be studying the abnormal “fraud psychology" of this case.

4) Germany ranks among the top ten countries for low corruption according to Transparency International. Yet VW is not alone among German companies in making major headlines with massive ethics failures in recent years, joining Siemens, Bayer, Deutsche Bank, and many others. What does this mean for the future of Germany’s role as a force for anti-corruption at home and internationally?

5) Former VW CEO Winterkorn resigned but claimed he knew nothing about the scandal. What does this say about the structure and management culture of Germany’s largest companies? How widespread is “plausible deniability” in German business culture--and in all business culture everywhere? If so, what are the dangers of this going forward, and what should be done to address them?

In 2005, billionaire hedge fund manager Eddie Lampert acquired a large portion of Sears Holdings, the parent company of Sears and Kmart, among other brands. In 2008, Lampert reorganized the company into 30 autonomous business units that would operate like independent businesses, with their own IT contracts, marketing officers, and most importantly, annual financial statements. The idea was that having each unit compete for resources would drive better decision-making and boost profits overall. The exact opposite happened. The divisions turned against one another, making decisions that benefited their divisions at the expense of others. In the year after Lampert’s acquisition of Sears, the company thrived, but two years later, profits tanked, the share price plummeted, and hundreds of stores were closed. As Jillian Popadak explains in a new paper about corporate culture and firm value, erosion of corporate culture may be to blame.

It’s not the case that decentralization is always bad—some large technology companies take this approach—but in Sears’s case, the reorganization changed the norms and culture for employees, dis-incentivizing collaboration at the expense of the overall firm. Popadak notes that former Sears employees speak to this: they said the change created a “warring-tribes culture” that lacked cooperation, and “the result was confusing to the customer.” Media accounts tell a similar story. Accounts detail managers cutting floor staff to save money, intense rivalries over the space in the weekly circular, resulting in nonsense product combinations, and a paltry one percent investment in capital expenditures. Popadak argues this is an example of how important implicit norms can be when they are working to create value at the company. When the explicit emphasis on performance was introduced, it “overpowered the implicit values to collaborate, satisfy the customer, and not act selfishly.”

How can you tell if a firm’s culture creates long-term value, or even measure something so seemingly unquantifiable? Popadak argues that while corporate governance measures are designed to change the explicit rules at a company, the culture is a set of implicit rules that govern employee behavior: the expectations employees have about what it takes to be successful at the firm. In her paper, Popadak collected millions of reviews from job sites like Glassdoor.com, Payscale.com, and CareerBliss.com by year and firm, and then used the text of the reviews to create measures of firm culture based on six categories: adaptability, collaboration, customer-orientation, detail-orientation, results-orientation, and integrity. She then assessed how these measures changed when a firm underwent a governance change.

Popadak writes of this graphic, “The figure shows that firms with stronger shareholder governance exhibited statistically significant increases in results-orientation but decreases in customer-orientation, integrity, and collaboration in the year following the governance change.” In the short term, a move to results-orientation boosts sales growth and payout in the short term, but in the long term, there are “significant declines in intangible value, customer satisfaction and brand value.” Ultimately, Popadak concludes that sacrificing corporate culture for short-term payoff may not be worth it.

Introduction

Many American workers do not have access to employer-sponsored payroll deduction plans for retirement saving. Groups with low rates of access include younger workers, members of minority groups, and those with low-to-moderate incomes. 1 Small business employees are especially at risk. Only about 14 percent of businesses with 100 or fewer employees offer their employees a retirement plan, leaving between 51 and 71 percent of the roughly 42 million people who work for a small business without access to an employer-administered plan (Government Accountability Office 2013).

Lack of access makes it difficult to build retirement wealth. A study by the Employee Benefit Research Institute (2014) shows that 62 percent of employees with access to an employer-sponsored plan held more than $25,000 in saving balances and 22 percent had $100,000 or more. In contrast, among those without access to a plan, 94 percent held less than $25,000 and only three percent hold $100,000 or more. Although workers without an employer-based plan can contribute to Individual Retirement Accounts (IRAs), very few do.2 But employees at all income levels tend to participate at high rates in plans that are structured to provide guidance about the decisions they should make (Wu and Rutledge 2014).

With these considerations in mind, many experts and policy makers have advocated for increased retirement plan coverage. While a national approach would be desirable, there has been little legislative progress to date. States, however, are acting. Three states have already created state-sponsored retirement saving plans for small business employees, and 25 are in some stage of considering such a move (Pension Rights Center 2015). John and Koenig (2014) estimate that 55 million U.S. wage and salary workers between the ages of 18 and 64 lack the ability to save for retirement through an employer-sponsored payroll deduction plan. Among such workers with wages between $30,000 and $50,000 only about one out of 20 contributes regularly to an IRA (Employee Benefit Research Institute 2006).

This paper highlights a variety of issues that policymakers will need to address in creating and implementing an effective state-sponsored retirement saving plan. Section II discusses policy design choices. Section III discusses management issues faced by states administering such a plan, employers and employees. Section IV is a short conclusion.

Note: this paper was presented at a October 7, 2015 Brookings Institution event focused on state retirement policies.

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Many American workers do not have access to employer-sponsored payroll deduction plans for retirement saving. Groups with low rates of access include younger workers, members of minority groups, and those with low-to-moderate incomes. Small business employees are especially at risk. Only about 14 percent of businesses with 100 or fewer employees offer their employees a retirement plan, leaving between 51 and 71 percent of the roughly 42 million people who work for a small business without access to an employer-administered plan (Government Accountability Office 2013).

Lack of access makes it difficult to build retirement wealth. A study by the Employee Benefit Research Institute (2014) shows that 62 percent of employees with access to an employer-sponsored plan held more than $25,000 in saving balances and 22 percent had $100,000 or more. In contrast, among those without access to a plan, 94 percent held less than $25,000 and only 3 percent hold $100,000 or more. Although workers without an employer-based plan can contribute to Individual Retirement Accounts (IRAs), very few do. But employees at all income levels tend to participate at high rates in plans that are structured to provide guidance about the decisions they should make (Wu and Rutledge 2014).

With these considerations in mind, many experts and policy makers have advocated for increased retirement plan coverage. While a national approach would be desirable, there has been little legislative progress to date. States, however, are acting. Three states have already created state-sponsored retirement saving plans for small business employees, and 25 are in some stage of considering such a move (Pension Rights Center 2015).

This policy brief, based on John and Gale (2015), highlights a variety of issues that policymakers will need to address in creating and implementing an effective state-sponsored retirement saving plan.

Download "Policy Design and Management Issues for State Retirement Saving Plans" »

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The latest BLS jobs report shows little sign employers are worried about the future strength of the recovery. Both the employer and household surveys suggest U.S. employers have an undiminished appetite for new hires. Nonfarm payrolls surged 242,000 in February, and upward revisions BLS employment estimates for January added almost 21,000 to estimated payroll gains in that month.

The household survey shows even bigger job gains in recent months. An additional 530,000 respondents said they were employed in February compared with January. This follows reported employment gains of 485,000 and 615,000 in December and January. Over the past year the household survey showed employment gains that averaged 237,000 per month. In comparison, the employer survey reported payroll gains averaging 223,000 a month.

These monthly gains are about three times faster than the job growth needed to keep the unemployment rate from climbing. As a result, the unemployment rate has fallen over the past year, reaching 4.9 percent in January. The jobless rate remained unchanged in February because of a continued influx of adults into the workforce. An additional 555,000 people entered the labor force, capping a three-month period which saw the labor force grow by over 500,000 a month. The labor force participation rate continued to inch up, rising 0.2 percentage points in February compared with the previous month. Since reaching a 38-year low in September 2015, the labor force participation rate has risen 0.5 points.

More than half the decline in the participation rate between the onset of the Great Recession and today is traceable to the aging of the adult population. A growing share of Americans are in late middle age or past 65, ages when we anticipate participation rates will decline. If we focus on the population between 25 and 54, the participation rate stopped declining in 2013 and has edged up 0.6 percentage points since hitting its low point. The employment-to-population rate of 25-54 year-olds has increased 3.0 percentage points since reaching a low in 2009 and 2010. Using the employment rate of 25-54 year-olds as an indicator of labor market tightness, we have recovered about 60 percent of the employment-rate drop that occurred in the Great Recession. Eliminating the rest of the decline will require a further increase in prime-age labor force participation.

Two other indicators suggest the job market remains some distance from a full recovery. More than a quarter of the 7.8 million unemployed have been jobless 6 months or longer. The number of long-term unemployed is about 70 percent higher than was the case just before the Great Recession. Nearly 6 million Americans who hold part-time jobs indicate they want to work on full-time schedules. They cannot do so because they have been assigned part-time hours or can only find a part-time job. The number of workers in this position is more than one-third higher than the comparable number back in 2007. Nonetheless, nearly all indicators of labor market tightness have displayed continued improvement in recent months.

February’s surge in employment growth and labor force participation was accompanied by an unexpected drop in nominal wages. Average hourly pay fell from $25.38 to $25.35 per hour. Compared with average earnings 12 months ago, workers saw a 2.2 percent rise in nominal hourly earnings. Because inflation is low, this probably translates into a real wage gain of about 1 percent. While employers may have an undiminished appetite for new hires, they show little inclination to boost the pace of wage increases.

Americans are enjoying longer lifespans than ever before. Living longer affords individuals the opportunity to make more contributions to the world, to spend more time with their loved ones, and to devote more years to their favorite activities – but a longer life, and particularly a longer retirement, is also expensive. The retirement security landscape is evolving as workers, employers, retirees, and financial services companies find their needs shifting. Once, many workers planned to stay with a single employer for most or all of their careers, building up a sizeable pension and looking forward to a comfortable retirement. Today, workers more and more workers will be employed by many different employers.  Additionally, generous defined benefit (DB) retirement plans are less popular than they once were – though they were never truly commonplace – and defined contribution (DC) plans are becoming ever more prevalent.  

Figure 1, below, shows the change from DB to DC that has occurred over the past three decades.

In the past many retirees struggled financially towards the end of their lives, just as they do now, but even so, the changes to the retirement security landscape have been real and marked, and have had a serious impact on workers and retirees alike. DB plans are dwindling, DC plans are on the rise, and as a result individuals must now take a more active role in managing their retirement savings. DC plans incorporate contributions from employees and employers alike, and workers much choose how to invest their nest egg.  When a worker leaves a job for retirement or for a different job he or she will often roll over the money from a 401(k) plan into an Individual Retirement Account (IRA). While having more control over one’s retirement funds might seem on its face to be a net improvement, the reality is that the average American lacks the financial literacy to make sound decisions (SEC 2012).

The Council of Economic Advisers (CEA) expressed concern earlier this year that savers with IRA accounts may receive poor investment advice, particularly in cases where their financial advisors are compensated through fees and commissions. “[The] best recommendation for the saver may not be the best recommendation for the adviser’s bottom line” (CEA 2015). President Obama echoed these concerns in a speech at AARP in February, asking the Department of Labor (DoL) to update its rules for financial advisors to follow when handling IRA accounts (White House 2015). The DoL receives its authority to craft such rules and requirements from the 1974 Employee Retirement Income Security Act (ERISA) (DoL 2015a).

The DoL recently proposed a regulation designed to increase consumer protection by treating some investment advisors as fiduciaries under ERISA and the 1986 Internal Revenue Code (DoL 2015b). The proposed rule has generated heated debate, and some financial advisors have responded with great concern, arguing that it will be difficult or impossible to comply with the rule without raising costs to consumers and/or abandoning smaller accounts that generate little or no profit. Advisors who have traditionally offered only the proprietary products of a single company worry that the business model they have used for many years will no longer be considered to be serving the best interests of clients.

Rather than offering detailed comments on the DoL proposals, this paper will look more broadly at the problem of saving for retirement and the role for professional advice. This is, of course, a well-travelled road with a large literature by academics, institutions and policy-makers, however, it is worthwhile to think about market failures, lack of information and individual incentives and what they imply for the investment advice market.

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With keynote addresses by Federal Reserve Governor Jerome Powell and Counselor to the Treasury Secretary Antonio Weiss

Bond markets are the principal source of credit for businesses and governments in the United States, with almost $40 trillion of outstanding debt. They are also the main mode of investment for pension funds, mutual funds, and many other investors, which is why the safety and efficiency of these markets is, therefore, crucial.

On August 3, the Economic Studies program at Brookings hosted a number of experts to discuss the structure of bond markets in the U.S. and how changes over the last few years are affecting market liquidity, volatility, and overall safety and efficiency. Keynote addresses by Governor Jerome Powell and Counselor Antonio Weiss focused on the Treasury bond market with a panel of experts examining corporate bond markets.

After each session, the speakers and panelists took audience questions.

Antonio Weiss with Jerome Powell and Douglas Elliott (l-r)

Martin Baily with Kashif Riaz, Annette Nazareth, Steve Zamsky and Dennis Kelleher (r-l)

Video

• Keynote Addresses on the U.S. Treasury Markets
• Panel on the Corporate Bond Markets

Audio

• Are there structural issues in U.S. bond markets?

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20150803_bond_markets_transcript
• 20150803_liquidity_kelleher_presentation

With only a few months remaining before the 2004 elections, national party committees continue to demonstrate financial strength and noteworthy success in adapting to the more stringent fundraising rules imposed by the Bipartisan Campaign Reform Act (BCRA). A number of factors, including the deep partisan divide in the electorate, the expectations of a close presidential race, and the growing competition in key Senate and House races, have combined with recent party investments in new technology and the emergence of the Internet as a major fundraising tool to produce what one party chairman has described as a "perfect storm" for party fundraising.¹ Consequently, both national parties have exceeded the mid-year fundraising totals achieved in 2000, and both approach the general election with substantial amounts of money in the bank.

After eighteen months of experience under the new rules, the national parties are still outpacing their fundraising efforts of four years ago. As of June 30, the national parties have raised $611.1 million in federally regulated hard money alone, as compared to $535.6 million in hard and soft money combined at a similar point in the 2000 election cycle. The Republicans lead the way, taking in more than $381 million as compared to about $309 million in hard and soft money by the end of June in 2000. The Democrats have also raised more, bringing in $230 million as compared to about $227 million in hard and soft money four years ago. Furthermore, with six months remaining in the election cycle, both national parties have already raised more hard money than they did in the 2000 election cycle.² In fact, by the end of June, every one of the Democratic and Republican national party committees had already exceeded its hard money total for the entire 2000 campaign.³

This surge in hard money fundraising has allowed the national party committees to replace a substantial portion of the revenues they previously received through unlimited soft money contributions. Through June, these committees have already taken in enough additional hard money to compensate for the $254 million of soft money that they had garnered by this point in 2000, which represented a little more than half of their $495 million in total soft money receipts in the 2000 election cycle.

View the accompanying data tables (PDF - 11.4 KB)

¹Terrence McAuliffe, Democratic National Committee Chairman, quoted in Paul Fahri, "Small Donors Grow Into Big Political Force," Washington Post, May 3, 2004, p. A11.
²In 2000, the Republican national party committees raised $361.6 million in hard money, while the Democratic national committees raised $212.9 million. These figures are based on unadjusted data and do not take into account any transfers of funds that may have taken place among the national party committees.
³The election cycle totals for 2000 can be found in Federal Election Commission, "FEC Reports Increase in Party Fundraising for 2000," press release, May 15, 2001. Available at http://www.fec.gov/press/press2001/051501partyfund/051501partyfund.html (viewed July 28, 2004).

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Super PACs have already spent tens of millions of dollars in the race for the GOP presidential nomination, with more to come. Expert Anthony Corrado says that the unlimited spending by the PACs, made possible by two Supreme Court decisions, is giving wealthy individuals unprecedented influence in the 2012 elections.

Video

• The Influence of Super PACs on the 2012 Elections

Audio

• @Brookings Podcast: The Influence of Super PACs on the 2012 Elections

The Syndrome, the villain in the 2004 animated movie “The Incredibles,” is an ordinary guy who has a plan to put an end to superheroes by making everyone a superhero.

Syndrome’s evil machinations came to fruition on Tuesday, Feb. 5, 2008.

The political parties permit states to hold their presidential nominating contests as early as the first Tuesday in February, with familiar states such as Iowa and New Hampshire given exemptions. Other states jealous of the attention lavished on those early states plotted to make their primaries or caucuses sooner, sometimes even violating party rules and suffering a penalty as a consequence.

To quote Syndrome, when everyone is a super, no one is a super. And so it was with the Super Tuesday states.

Although not intended, a national primary emerged as 24 states fell over one another in a Keystone Kop spectacle by moving up their primaries and caucuses to Feb. 5.

Some argued that this would be good for the political parties in the general election since only a candidate who could run a national campaign would win the nomination.

Ironically, the candidates acted just like they do in a general election, where they concentrate on the competitive battleground states. On Super Tuesday they decided where they could be competitive, where they could pick up delegates, and targeted their scarce resources to those states.

States that thought they would be relevant found themselves irrelevant safe states that the candidates passed by and simply helped run up delegate totals for their favored candidate.

A year ago, the campaigns were focused on building organizations and cultivating supporters in the early contest states of Iowa and New Hampshire. Some candidate strategies were solely focused on jump-starting their campaigns by winning these early states, and others hoped that decisive wins would quickly seal the nomination. Some of the better-financed campaigns could be forward-looking, but they still would not want to spend time and money on Super Tuesday states unless they were sure they would need to.

By the time the nomination process was whittled down to the remaining players and the campaigns could start their Super Tuesday planning, little time was left to advertise, send direct mail and build volunteer organizations. Even where the campaigns decided they could be competitive, too many states were in play for the campaigns to pour in the same resources they did in Iowa and New Hampshire.

The resulting dynamic had a twofold effect on voter participation in this year of high voter interest.

Lack of competition drove down turnout in states such as New York, where Sens. Hillary Rodham Clinton (D-N.Y.) and John McCain (R-Ariz.) were expected to win big victories. Only 19 percent of eligible New Yorkers voted, compared with 53 percent in New Hampshire.

Lack of organization and campaigning drove turnout down across the board, as all primary states combined averaged a turnout rate of 29 percent. Poor organization particularly afflicted the caucuses, which require campaign organizations to mobilize supporters to give up an entire evening. While 16 percent of eligible Iowans attended caucuses, the combined attendance rate for the four states holding caucuses for both political parties was a meager 6 percent.

The silver lining is that continued voter interest buoyed participation where competition and organization failed. Turnout likely would have been much worse if the nominees already had been decided.

As we move forward from Super Tuesday, those states that did not crowd to the front of the line will now find themselves being courted a little more graciously and intensely by the campaigns. This should help increase voter participation. However, the nomination battles are still coming rather fast and furiously, so the campaigns still can’t give the extended engagement they do for the early states. Some campaigns are now facing hard choices as to where they can spend their limited remaining resources. Except for perhaps a few intensely fought competitive states remaining, voter turnout has thus likely peaked in this election cycle.

We expected Super Tuesday to soar into the stratosphere. Instead, it was more of a flop, a cheap imitation of Iowa and New Hampshire. When the dust settles after this primary season and we look back at how the parties nominate their candidates, we will still be searching for a way to have more equitable involvement by voters in all states.

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As the recent primary in Delaware attests, this year's midterm elections continue to offer unexpected twists and raise large questions. Will the Republicans take over the House and possibly the Senate? Or has the Republican wave ebbed? What role will President Obama play in rallying seemingly dispirited Democrats -- and what effect will reaction to the sluggish economy play in rallying Republicans? Is the Tea Party more an asset or a liability to the G.O.P.'s hopes? What effect will the inevitably narrowed partisan majorities have in the last two year's of Obama's first term? And how will contests for governorships and state legislatures around the nation affect redistricting and the shape of politics to come?

On October 4, a panel of Brookings Governance Studies scholars, moderated by Senior Fellow E.J. Dionne, Jr., attempted to answer these questions. Senior Fellow Thomas Mann provided an overview. Senior Fellow Sarah Binder discussed congressional dynamics under shrunken majorities or divided government. Senior Fellow William Galston offered his views on the administration’s policy prospects during the 112th Congress. Nonresident Senior Fellow Michael McDonald addressed electoral reapportionment and redistricting around the country.

Video

• Partisan Gridlock post-Elections?
• GOP Influence over Redistricting, Reapportionment
• Working Within Divided Government
• Good Conditions for GOP in 2010 Midterms

Audio

• Midterm Elections 2010: Driving Forces, Likely Outcomes, Possible Consequences

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20101004_midterm_elections

On March 4, President Obama submitted to Congress his 2015 budget request. Keeping with the spending cap deal agreed last December with Congress, the level of federal R&D will remain flat; and, when discounted by inflation, it is slightly lower. The requested R&D amount for 2015 is $135.4 billion, only $1.7 billion greater than 2014. If we discount from this 1.2% increase the expected inflation of 1.7% we are confronting a 0.5% decline in real terms.

Reaction of the Research Community

The litany of complaints has started. The President’s Science and Technology Advisor, John Holdren said to AAAS: “This budget required a lot of tough choices. All of us would have preferred more." The Association of American Universities, representing 60 top research universities, put out a statement declaring that this budget does “disappointingly little to close the nation’s innovation deficit,” so defined by the gap between the appropriate level of R&D investment and current spending.

What’s more, compared to 2014, the budget request has kept funding for scientific research roughly even but it has reallocated about $250 million from basic to applied research (see Table 1). Advocates of science have voiced their discontent. Take for instance the Federation of American Societies for Experimental Biology that has called the request a “disappointment to the research community” because the President’s budget came $2.5 billion short of their recommendations.

The President’s Research and Development Budget 2015

Source: OMB Budget 2015

These complaints are fully expected and even justified: each interest group must defend their share of tax-revenues. Sadly, in times of austerity, these protestations are toothless. If they were to have any traction in claiming a bigger piece of the federal discretionary pie, advocates would have to make a comparative case showing what budget lines must go down to make room for more R&D. But that line of argumentation could mean suicide for the scientific community because it would throw it into direct political contest with other interests and such contests are rarely decided by the merits of the cause but by the relative political power of interest groups. The science lobby is better off issuing innocuous hortatory pronouncements rather than picking up political fights that it cannot win.

Thus, the R&D slice is to remain pegged to the size of the total budget, which is not expected to grow, in the coming years, more than bonsai. The political accident of budget constraints is bound to change the scientific enterprise from within, not only in terms of the articulation of merits—which means more precise and compelling explanations for the relative importance of disciplines and programs—but also in terms of a shrewd political contest among science factions.

Policies and initiatives to promote U.S. manufacturing would be well advised to take a value chain perspective of this economic sector. Currently, our economic statistics do not include pre-production services to manufacturing such as research and development or design or post-production services such as repair and maintenance or sales. Yet, manufacturing firms invest heavily in these services because they are crucial to the success of their business. 

In a new paper, Kate Whitefoot and Walter Valdivia offer a fresh insight into the sector’s labor composition and trends by examining employment in manufacturing from a value chain perspective. While the manufacturing sector shed millions of jobs in the 2002-2010 period—a period that included the Great Recession—employment in upstream services expanded 26 percent for market analysis, 13 percent for research and development, and 23 percent for design and technical services. Average wages for these services increased over 10 percent in that period. Going forward, this pattern is likely to be repeated. Technical occupations, particularly in upstream segments are expected to have the largest increases in employment and wages.

In light of the findings, the authors offer the following recommendations: 

• Federal manufacturing policy: Expand PCAST’s Advanced Manufacturing Partnership recommendations—specifically, for developing a national system of certifications for production skills and establishing a national apprenticeship program for skilled trades in manufacturing—to include jobs outside the factory such as those in research and development, design and technical services, and market analysis.
• Higher education: Institutions of higher education should consider some adjustment to their curriculum with a long view of the coming changes to high-skill occupations, particularly with respect to problem identification and the management of uncertainty in highly automated work environments. In addition, universities and colleges should disseminate information among prospect and current students about occupations where the largest gains of employment and higher wage premiums are expected. 
• Improve national statistics: Supplement the North American Industry Classification System (NAICS) with data that permits tracking the entire value chain, including the development of a demand-based classification system. This initiative could benefit from adding survey questions to replicate the data collection of countries with a Value Added Tax—without introducing the tax, that is—allowing in this manner a more accurate estimation of the value added by each participant in a production network.

Whitefoot and Valdivia stress that any collective efforts aimed at invigorating manufacturing must seize the opportunities throughout the entire value chain including upstream and downstream services to production.

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NASA’s Asteroid Initiative encompasses efforts for the human exploration of asteroids—as well as the Asteroid Grand Challenge—to enhance asteroid detection capabilities and mitigate their threat to Earth. The human space flight portion of the initiative primarily includes the Asteroid Redirect Mission (ARM), which is a proposal to put an asteroid in orbit of the moon and send astronauts to it. The program originally contemplated two alternatives for closer study: capturing a small 10m diameter asteroid versus simply recovering a boulder from a much larger asteroid. Late in March, NASA offered an update of its plans. It has decided to retrieve a boulder from an asteroid near Earth’s orbit—candidates are the asteroids 2008 EV5, Bennu, and Itokawa—and will place the boulder on the moon’s orbit to further study it.

This mission will help NASA develop a host of technical capabilities. For instance, Solar Electric Propulsion uses solar electric power to charge atoms for spacecraft propulsion—in the absence of gravity, even a modicum of force can alter the trajectory of a body in outer space. Another related capability under development is the gravity tractor, which is based on the notion that even the modest mass of a spacecraft can exert sufficient gravitational force over an asteroid to ever so slightly change its orbit. The ARM spacecraft mass could be further increased by its ability to capture a boulder from the asteroid that is steering clear of the Earth, enabling a test of how humans might prevent asteroid threats in the future. Thus, NASA will have a second test of how to deflect near-Earth objects on a hazardous trajectory. The first test, implemented as part of the Deep Impact Mission, is a kinetic impactor; that is, crashing a spacecraft on an approaching object to change its trajectory.

The Asteroid Initiative is a partner of the agency’s Near Earth Object Observation (NEOO) program. The goal of this program is to discover and monitor space objects traveling on a trajectory that could pose the risk of hitting Earth with catastrophic effects. The program also seeks to develop mitigation strategies. The capabilities developed by ARM could also support other programs of NASA, such as the manned exploration of Mars.

NEOO has recently enjoyed an uptick of public support. It used to be funded at about $4 million in the 1990s and in 2010 was allocated a paltry $6 million. But then, a redirection of priorities—linked to the transition from the Bush to the Obama administrations—increased funding for NEOO to about $20 million in 2012 and $40 million in 2014—and NASA is seeking $50 million for 2015. It is clear that NASA officials made a compelling case for the importance of NEOO; in fact, what they are asking seems quite a modest amount if indeed asteroids pose an existential risk to life on earth. At the same time, the instrumental importance of the program and the public funds devoted to it beg the question as to whether taxpayers should have a say in the decisions NASA is making regarding how to proceed with the program.

NASA has done something remarkable to help answer this question.

Last November, NASA partnered with the ECAST network (Expert and Citizen Assessment of Science and Technology) to host a citizen forum assessing the Asteroid Initiative. ECAST is a consortium of science policy and advocacy organizations which specializes in citizen deliberations on science policy. The forum consisted of a dialogue with 100 citizens in Phoenix and Boston who learned more about the asteroid initiative and then commented on various aspects of the project.

The participants, who were selected to approximate the demographics of the U.S. population, were asked to assess mitigation strategies to protect against asteroids. They were introduced to four strategies: civil defense, gravity tractor, kinetic impactor, and nuclear blast deflection. As part of the deliberations, they were asked to consider the two aforementioned approaches to perform ARM. A consensus emerged about the boulder retrieval option primarily because citizens thought that option offered better prospects for developing planetary defense technologies.  This preference existed despite the excitement of capturing a full asteroid, which could potentially have additional economic impacts. The participants showed interest in promoting the development of mitigation capabilities at least as much as they wanted to protect traditional NASA goals such as the advancement of science and space flight technology. This is not surprising given that concerns about doomsday should reasonably take precedence over traditional research and exploration concerns.

NASA could have decided to set ARM along the path of boulder retrieval exclusively on technical merits, but having conducted a citizen forum, the agency is now able to claim that this decision is also socially robust, which is to say, is responsive to public values of consensus. In this manner, NASA has shown a promising method by which research mission federal agencies can increase their public accountability.

In the same spirit of responsible research and innovation, a recent Brookings paper I authored with David Guston—who is a co-founder of ECAST—proposes a number of other innovative ways in which the innovation enterprise can be made more responsive to public values and social expectations.

Kudos to NASA for being at the forefront of innovation in space exploration and public accountability.