Archive for September, 2008

U.S. Policy Regarding Pandemic-Influenza Vaccines

Monday, September 15th, 2008

The emergence of H5N1, or “avian flu,” motivated the Department of Health and Human Services’ 2005 plan to prepare for and combat an influenza pandemic. Three years ago domestic manufacturers were unable to rapidly produce enough vaccine to protect the more than 300 million people living in the United States. That remains the case today. With current technology, a pandemic could circle the globe more quickly than vaccines could be produced.

HHS’s plan has enlarged the role of the federal government in the influenza vaccine market, and the paper released by CBO today examines that increasingly prominent role — in developing new vaccines, expanding the capacity of the industry to manufacture them, and procuring stockpiles of prepandemic vaccines.

HHS’s plan has multiple objectives, including to:

  • Increase manufacturing capacity by refurbishing and expanding plants that produce vaccines using traditional egg-based processes (developed in the 1940s) and increasing more costly cell-based manufacturing technology.
  • Make vaccines available more quickly. The plan takes two approaches to this objective. First, stockpile a relatively small amount of prepandemic vaccines that could blunt the worst effects of a pandemic by protecting particularly vulnerable groups and first responders. Second, develop so-called next-generation vaccines that can be produced more rapidly than currently available vaccines to more efficiently  meet long term needs.

Ongoing research has changed the environment in which HHS’s plan was originally formulated in at least one important regard. Adjuvants—substances that may be added to influenza vaccines to reduce the amount of active ingredient (called antigen) needed per dose of vaccine—are showing promise in clinical trials in the United States; some of them have been approved for limited uses in Europe. That promise may offer a basis on which to make adjustments to HHS’s plan.

 Specifically, CBO reached the following conclusions:

  • The manufacturers of currently approved vaccines made in the United States cannot produce vaccines of sufficient effectiveness, in sufficient quantities, or in the time required to meet public health needs in the event of an influenza pandemic.
  • In the short term, adjuvanted vaccines offer the best hope for achieving HHS’s goal of having enough vaccine to protect 300 million people within six months of the outbreak of an influenza pandemic.
  • CBO estimates that it would cost between $1.2 billion and $1.8 billion to build new facilities for producing adjuvanted cell-based vaccines and between $7.6 billion and $11.4 billion to build new production facilities for cell-based vaccines without adjuvants.
  • Manufacturing capacity needed to produce pandemic-influenza vaccine exceeds that necessary to make seasonal vaccine; ongoing federal support may be required to meet and maintain necessary capacity.

Adjuvants developed since 2005 could substantially reduce the amount of antigen needed per dose, raising the question about whether HHS’s current policy is the most cost-effective approach to meeting its vaccine production goals. In light of this, the report briefly examines several other options to consider if adjuvanted vaccines prove successful, including reducing capacity targeted for manufacturing cell-based influenza vaccines while expanding resources available to support development of next-generation vaccines, entering into advance supply agreements (an approach used by several European nations that allows countries to make advance payments to manufacturers in exchange for a guaranteed supply of vaccine in the event of a pandemic); and modifying the size of the planned vaccine stockpile.
 

Loan guarantees for auto manufacturers

Friday, September 12th, 2008

Last year, the Congress authorized the Department of Energy to make $25 billion in loans to auto manufacturing firms and suppliers of automotive components. Manufacturers could use those loans to reequip or establish facilities to produce “advanced technology vehicles” that would meet certain emissions and fuel economy standards; component suppliers could borrow funds to retool or build facilities to produce parts for such vehicles.

Subsequent funding was required before such loans could be made, and that funding has not yet been provided.  The budgetary cost for such loans, based on the rules in the Federal Credit Reform Act of 1990, reflects the expected cost to the government of any subsidy, not the face value of the loans.

Several recent press reports have incorrectly suggested that CBO has estimated a 15 percent subsidy cost for loans to the automakers, so that $25 billion in loans would cost $3.75 billion.  CBO’s analysis, however, suggests a 30 percent subsidy cost for such loans under the conditions specified in the authorizing legislation.  The resulting subsidy cost would imply a budget cost of $7.5 billion for $25 billion in loans.  (Early this year, CBO had informally suggested a 15 percent subsidy cost.   Since then, however, credit conditions for the auto manufacturers have deteriorated markedly — the market interest rates on their outstanding debt, for example, have risen dramatically.)

Recommended readings from the Journal of Economic Perspectives

Thursday, September 11th, 2008

Tim Taylor has always struck me as wise. And not just because of this section from his most recent “Recommendations for Further Reading” in The Journal of Economic Perspectives:

CBO and the Health Care System

Our national debate over reform of the nation’s health care system would be vastly improved if all participants familiarized themselves with recent Congressional Budget Office reports on the subject. Here are some examples:

“The Long-Term Outlook for Health Care Spending” describes factors that will drive health care costs over the next 75 years. “[I ]n the absence of changes in federal law: Total spending on health care would rise from 16 percent of gross domestic product (GDP) in 2007 to 25 percent in 2025, 37 percent in 2050, and 49 percent in 2082. Federal spending on Medicare (net of beneficiaries’ premiums) and Medicaid would rise from 4 percent of GDP in 2007 to 7 percent in 2025, 12 percent in 2050, and 19 percent in 2082.” November 2007. The Long-Term Outlook for Health Care Spending

A February 2008 report discusses “Geographic Variation in Health Care Spending.” “Per capita health care spending varies widely across the United States. In 2004, as an example, per capita spending ranged from roughly $4,000 in Utah to $6,700 in Massachusetts. The variation is even greater among smaller geographic units and among individual medical providers. Among large hospitals in California from 1999 to 2003, Medicare spending per patient in the last two years of life ranged more than fourfold, from less than $20,000 to almost $90,000. Researchers affiliated with the Dartmouth Atlas of Health Care estimate that among groups of Medicare beneficiaries who are otherwise similar, individuals who live in highspending areas receive approximately 60 percent more in services than do those who live in low-spending areas.” Geographic Variation in Health Care Spending

A January 2008 report explores the connections between “Technological Change and the Growth of Health Care Spending.” “Technological innovation can theoretically reduce costs and, for many types of goods and services, often does. Historically, however, the nature of technological advances in medicine and the changes in clinical practice that followed them have tended to raise spending . . . .Breaking down the long-term growth in spending into its various components leaves much of the increase unaccounted for by measurable factors such as the aging of the population or rising personal income. Table 2 shows estimates from three studies of the contributions of selected factors to the long-term growth of health care spending in the United States. Overall, those factors [aging of the population, changes in third-party payment, personal income growth, prices in the health care sector, administrative costs, defensive medicine and supplier-induced demand] appear to account for no more than half of that growth. Analysts generally attribute the rest of the growth to increases in the technology-related changes in medical practice.” Technological Change and the Growth of Health Care Spending

“Research on the Comparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal Role” explains: “More recently, the Agency for Health Care Research and Quality (AHRQ) has been the most prominent federal agency supporting various types of research on the comparative effectiveness of medical treatments. Established in 1989, . . . [i]t currently has a staff of about 300 and an annual budget of over $300 million, which primarily funds research grants to and contracts with universities and other research organizations covering a wide range of topics in health services.” December 2007. Research on the Comparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal Role

“Evidence on the Costs and Benefits of Health Information Technology” arrived in May 2008. “Many analysts and policymakers believe that health IT [information technology] is a necessary ingredient for improving the efficiency and quality of health care in the United States. Despite the potential of health IT to increase efficiency and improve quality, though, very few providers—as of 2006, about 12 percent of physicians and 11 percent of hospitals—have adopted it.” Evidence on the Costs and Benefits of Health Information Technology

Update to the budget and economic outlook

Tuesday, September 9th, 2008

CBO released the annual summer update to the Budget and Economic Outlook for Fiscal Years 2008 to 2018 today. (Today’s report updates the Budget and Economic Outlook published in January 2008.)

Today’s report makes it challenging to avoid playing the dismal economist, which I generally dislike doing. The budget deficit has risen substantially over the past year. And according to CBO’s updated economic forecast, the economy is likely to experience at least several more months of weakness. (Whether this period will ultimately be designated a recession or not is still uncertain, but the increase in the unemployment rate and the pace of economic growth are similar to conditions during previous periods of mild recession.) Finally, the Treasury and Federal Housing Finance Agency have announced significant steps regarding Fannie Mae and Freddie Mac, which carry important implications for how the operations of those entities should be reflected in the federal budget.  The estimates presented in the report CBO released today do not reflect the specific details of those actions.

Some more details from today’s report include:

Budget projections

  • CBO estimates that the deficit for 2008 will be $407 billion, substantially higher than last year’s $161 billion. As a share of the economy, the deficit is projected to rise to 2.9 percent of GDP this year, up from 1.2 percent of GDP in 2007. That 1.7 percentage point increase as a share of GDP is roughly evenly split between a 0.9 percentage point decline in revenue relative to GDP (reflecting the impact of lower corporate tax revenue and the rebates enacted as part of stimulus legislation this year) and a 0.8 percentage point increase in spending relative to GDP.
  • Since March, the bottom line in CBO’s baseline over the next ten years has worsened by an average of nearly $260 billion per year. Some of that deterioration is due to the weakened economy, near-term inflation, and other economic variables; those factors increased projected deficits (or decreased projected surpluses) by about $85 billion a year. However, the larger component of the changes results from extrapolating into future years the supplemental appropriations enacted in June (in accordance with the rules governing the baseline).
  • Over the longer term, the fiscal outlook continues to depend mostly on the future course of health care costs as well as on the effects of a growing elderly population. CBO estimates that federal spending on Medicare and Medicaid will grow to 6 percent of the GDP in 2018 and 12 percent of the GDP by 2050.

Economic projections

  • An unusual amount of turbulence has roiled the U.S. economy this year, weakening the near-term outlook since CBO’s previous forecast.
  • Specifically, CBO forecasts that GDP will grow by about 1.5 percent in real terms in calendar year 2008 and 1.1 percent in calendar year 2009.
  • Inflation (as measured by change in the CPI-U) is projected to remain high and average 4.7 percent for 2008 but moderate in 2009, falling to an average of 3.1 percent.
  • CBO’s projections beyond the two year horizon indicate real growth averaging 2.8 percent and CPI-U inflation averaging 2.2 percent.

Fannie Mae and Freddie Mac

  • Significant government actions regarding Fannie Mae and Freddie Mac occured as this report went to press. The actions were taken to reduce the risk of a systemic shock to the financial system and to stabilize the mortgage markets.
  • In a letter issued on the topic in July, CBO noted that “a strong argument can be made that if the Treasury used the proposed authority, the GSEs’ operations should be incorporated directly into the federal budget.” CBO concluded that the proposal at that time, especially to the extent it would result in any government acquisition of an equity stake in the GSEs, raised a significant budgetary question. Currently, data on the GSEs are reported along with federal budget information each year, but the activity of those entities is not encompassed within the budget. As CBO noted at the time, “That treatment could change if the federal government’s financial stake or control changes in a significant way.”
  • Given the steps announced by the Treasury Department and the Federal Housing Finance Agency on September 7, it is CBO’s view that the operations of Fannie Mae and Freddie Mac should be directly incorporated into the federal budget. The GSEs’ revenue would be treated as federal revenue and their expenditures as federal outlays, with appropriate adjustments for the manner in which credit transactions (like a mortgage guarantee) are reflected in the federal budget.

Monthly Budget Review

Friday, September 5th, 2008

CBO released its Monthly Budget Review today. CBO estimates that the federal budget deficit was $486 billion in the first 11 months of the fiscal year, $212 billion more than the shortfall recorded over the same period last year.  CBO anticipates that the government will realize a surplus in September, stemming from quarterly payments of estimated income taxes. The result will be a deficit in the vicinity of $400 billion for the fiscal year. CBO will release a new estimate of the 2008 deficit and updated baseline projections for fiscal years 2009-2018 on September 9.

Total receipts for the first 11 months of fiscal year 2008 were about 1.4 percent lower than receipts in the same period in fiscal year 2007, CBO estimates. Individual income taxes showed a decline in receipts of 3 percent, primarily due to tax rebates. Social insurance (payroll tax) receipts grew by about 4 percent, and corporate receipts fell by about 15 percent during the period.