When a new drug is approved in the United States, it is virtually impossible to know all of the risks that a population may encounter when using that product. Even though the U.S. Food and Drug Administration (FDA) requires drug manufacturers to meet rigorous standards demonstrating the drug’s safety and effectiveness for its intended use, once approved, drugs can be used by many more patients than were studied in clinical trials. This may include patients with unique clinical conditions, differing health status, ethnicity, age, or other characteristics which were not well-represented before the drug’s approval. Further, the drugs themselves can be used in different ways and in different settings than were studied. Until recently, FDA did not have the necessary tools and data access to rapidly and consistently track the risks of serious side effects of regulated drugs after approval. Recognizing this challenge, FDA has developed a pilot system to make the best use of available electronic health data using a new data and research network capable of evaluating the safety of medical products in the U.S. 

Authorized by the Food and Drug Administration Amendments Act (FDAAA) of 2007, this pilot is known as Mini-Sentinel, and is part of FDA’s larger Sentinel Initiative. Sentinel was envisioned as a national electronic system to track the safety of regulated medical products, through the use of existing health insurance claims and electronic clinical data that are generated as part of routine care. In the four years since its inception, Mini-Sentinel has made tremendous progress toward developing this system. Mini-Sentinel is comprised of insurance claims and clinical data from 18 participating data-partners, including some of the largest private health plans in the United States. In order to best protect patient privacy, the data from each partner is maintained behind each individual health plan fire-wall. This “distributed data” approach allows a single coordinating center to distribute FDA safety questions in the form of “queries,” to each of the participating data partners to be run against their own data. Aggregated summary results are then sent back to the coordinating center for final analysis. This process allows FDA to access data that can help in addressing safety questions in near real-time.  

Through Mini-Sentinel, FDA has the capability to better understand the safety outcomes using electronic health care data of approximately 169 million covered lives. This accumulation of data represents the capture of 382 million person-years of observation time and billions of prescription dispensings.[1] Examples of the types of safety questions that have already been addressed by Mini-Sentinel include the following:

• Safety concerns with drugs used to treat high blood pressure and the incidence of angioedema;
• Safety concerns with a new diabetes treatment and the incidence of heart attacks; and
• Impact of FDA regulatory actions (i.e. drug label changes) intended to mitigate serious risks of drugs.

The Mini-Sentinel pilot has demonstrated substantial progress and has proven to be a very useful tool for FDA, largely due to the strong partnerships developed between FDA, collaborating academic institutions, and private health plans. However, in order to ensure continued progress and long-term sustainability, it will be critical for progress to continue in several key areas. 

First, continued methods development and data understanding will be necessary to ensure FDA has access to the most innovative tools. The field of pharmacoepidemiology and drug safety surveillance is still young and the continued development of better study designs and analytic tools to quantify risks of serious adverse events, while accounting for many confounding factors that are inherent on observational data, will be critical. Further, as health reforms impact that way health care is delivered and financed (e.g., development of accountable care organizations and increased use of bundled payments), the electronic health data will change. It will be important to focus efforts on understanding how these changes will impact data used for safety evaluations. 

Second, it is clear that Sentinel’s contributions may extend well beyond FDA’s medical product assessments. The tools and infrastructure that have been developed by FDA over the last four years could be used as a platform to establish a national resource for a more evidence-based learning health care system. This system will enable a better understanding of not only the risks, but also benefits and best uses, of drugs in the post-market settings. 

FDA has initiated steps to ensure the long-term sustainability and impact of Sentinel infrastructure and tools. Within the next few years, FDA has proposed that Sentinel be transitioned into three main components: the Sentinel Operations Center, the Nation Resource Data Infrastructure, and the Methodological Resource for Medical Product Surveillance using Electronic Healthcare Databases. FDA has indicated that while the Sentinel Operations Center will continue to serve as FDA’s portal to the distributed database, the Nation Resource Data Infrastructure could potentially be used by other groups to support broader evidence generation. Potential groups with interest in improving our understanding of the impact of medical products and who could benefit from this framework include the National Institutes of Health, the Regan-Udall Foundation, the Patient Centered Outcomes Research Institute, and other possible stakeholder groups, such as the private industry. 

Collectively, these components will ensure that FDA continues to have the tools to engage in medical product surveillance, while ensuring the long-term sustainability of the system. In just four years, the Sentinel Initiative has laid the groundwork to transform how FDA, and the nation, benefits from electronic health care data. This network continues to foster a community of stakeholders committed the evidence generation, which will ultimately contribute to a learning health care system.

For more information on these issues, including discussion by leaders from Sentinel stakeholders, please visit the Sentinel Initiative Public Workshop event page. There you will find archived video, presentations, and further reading.

Video

• New Advances in Medical Records Reflects the Realities of the U.S. Healthcare System

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.

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In many policy-related situations, the states can be useful laboratories to determine the most appropriate federal actions. Variations across states in health care programs, earned income credit rules, minimum wages, and other policies have helped inform debates about federal interventions.

In this paper, we reverse that approach. Many state and local governments currently face difficulties financing future pension obligations for their workers. The federal government, however, faced similar circumstances in the 1980s and successfully implemented a substantial reform. We examine the situation the federal government faced and how it responded to the funding challenge. We present key aspects of the situation facing state governments currently and draw comparisons between them and the federal situation in the 1980s. Our overarching conclusion is that states experiencing distress today about the cost and funding of its pension plans could benefit from following an approach similar to the federal government’s resolution of its pension problems in the 1980s.

The federal government retained the existing Civil Service Retirement System (CSRS) for existing employees and created a new Federal Employees’ Retirement System (FERS) for new employees. FERS combined a less generous defined benefit plan than CSRS, mandatory enrollment in Social Security, and a new defined contribution plan with extensive employer matching. Although we do not wish to imply that a “one size fits all” solution applies to the very diverse situations that different states face, we nonetheless conclude that the elements of durable, effective, and just reforms for state pension plans will likely include the major elements of the federal reform listed above.

Section II discusses the federal experience with pension reform. Section III discusses the status and recent developments regarding state and local pensions. Section IV discusses the similarities in the two situations and how policy changes structured along the lines of the federal reform could help state and local governments and their employees.

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In recent weeks, the Obama Administration has taken the two most important steps in nearly a decade to increase access to retirement savings for more than 55 million Americans who currently do not participate in a retirement saving plan.

The Treasury Department's myRA program, launched this month, will help new savers and the self-employed start accounts without risk or fees. And earlier this week, the Department of Labor clarified rules that will make it easier for states to create retirement savings plans for small business employees.

myRA

The new myRAs provide another way for new savers to build small nest eggs. They will also help consultants, contract employees, and part-time workers save for retirement or for emergencies. 

For employees, myRAs are payroll deduction savings accounts designed to meet the needs of new savers and lower income workers.  They have no fees, cost nothing to open, and allow savers to regularly contribute any amount.  Savings are invested in US Treasury bonds, so savers can’t lose principal, an important feature for low-income workers who might otherwise abandon plans if they face early losses.  Those who are not formal employees and thus lack access to an employer-sponsored plan can participate in myRA through direct withdrawals from a checking or other bank account. 

As the growing “gig economy” creates more independent workers, the myRA will be a valuable entry to the private retirement system.  These workers might otherwise retire on little more than Social Security. All workers can build myRA balances by redirecting income tax refunds into their accounts. Because a myRA is a Roth IRA (that is, contributions are made from after-tax income), savers can withdraw their own contributions at any time without penalties or tax liability.  

When a myRA reaches $15,000, it must be rolled into another account, and Treasury may make it possible for workers to transfer these savings into funds managed by one of several pre-approved private providers.  MyRAs won’t replace either state-sponsored plans or employer-related pension or retirement savings plans.  However, they will make it possible for new and lower-income savers as well as the self-employed to build financial security without risk or fees.  

State-Sponsored Retirement Savings Plans

The DOL announcement gave the green light to several state models, including Automatic IRAs, marketplace models, and Multiple Employer Plans.  About two dozen states are considering these plans and, so far, Illinois and Oregon have passed “Secure Choice” plans based on the Automatic IRA, while Washington State has passed a marketplace plan.

DOL’s proposed Automatic IRA rules (open for a 60 day comment period) would let states administer automatic enrollment payroll deduction IRAs provided that the plans meet certain conditions for selecting or managing the investments and consumer protections.  States would also have to require businesses to offer such a plan if they don’t already offer their employees a pension or other retirement savings plan. Companies that are not required to offer an Automatic IRA or other plan, but decide to join the state plan voluntarily could still be subject to ERISA. The Retirement Security Project at the Brookings Institution first designed the Automatic IRA, which was proposed by the Administration before being adopted by some states.

In a separate interpretation, DOL allowed states to offer marketplace plans without being subject to the Employee Retirement Income Security Act (ERISA).  These plans are essentially websites where small businesses may select pre-screened plans that meet certain fee or other criteria.  Under the DOL guidance, these marketplaces may include ERISA plans, but states cannot require employers to offer them.   However, if states sponsor a marketplace model, they could also require employers without other plans to offer Automatic IRAs.

Finally, DOL’s rules let states administer Multiple Employer Plans (MEPs), where individual employers all use the same ERISA-covered model plan.  MEPs are usually simplified 401(k)-type plans. Because the state would be acting on behalf of participating employers, it could assume some functions that would otherwise be the responsibility of the employer. These include handling ERISA compliance, selecting investments, and managing the plan.

The Retirement Security Project has issued a paper and held an event discussing ways states could create small business retirement savings plans. The paper is available here and the event is available here.

Together, the two initiatives—the new MyRA and the state-sponsored plans-- could greatly increase the number of American workers who’ll be able to supplement their Social Security benefits with personal savings.

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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