US Medical - Part 2

The Food and Drug Administration (FDA) is the primary institution tasked with the safety and effectiveness of human and veterinary drugs. It approves products and establishes drug and medical device manufacturing and performance standards. One of the more contentious issues related to drug safety is immunity from prosecution. In 2004, the FDA reversed a federal policy, arguing that FDA premarket approval overrides most claims for damages under state law for medical devices; this was confirmed by the Supreme Court in Riegel v Medtronic in 2008. On 30 June 2006 an FDA ruling went into effect extending protection from lawsuits to pharmaceutical manufacturers even if it was found that they submitted fraudulent clinical trial data to the FDA in their quest for approval; leaving consumers with serious health consequences from drug use with little recourse; in 2007 opposition to the ruling was raised in the US House but the Senate upheld the status quo and on March 4, 2009 the US Supreme Court handed down a decision in Wyeth v Levine asserting that state-level rights of action could not be pre-empted by federal immunity and could provide "appropriate relief for injured consumers." In June 2009 under the Public Readiness and Emergency Preparedness Act, Health and Human Services signed an order extending protection to vaccine makers and federal officials during a declared health emergency related to the administration of the swine flu vaccine. When health care legislation was being written in 2009 the drug companies were asked to support the legislation in return for not allowing importation of drugs from foreign countries; as a result on January 4, 2012 we heard the number of new drug shortages is at a record high and on February 10 the drug Methotrexate Sodium used to cure about 90% of the kids with Leukemia to which there is no alternative is in short supply because the 4 companies that make the low profit drug are having production problems or can’t meet the demand; on February 22 more companies are approved to reduce the shortage.

The Office of the Actuary (OACT) of the Centers for Medicare and Medicaid Services publishes data on total health care spending in the United States, including both historical levels and future projections. In 2007 the US spent $2.26 trillion on health care, or $7,439 per person, up from $2.1 trillion, or $7,026 per capita, the previous year. Growth in spending is projected to average 6.7% annually over the period 2007 through 2017. However, in September 2008 the Wall Street Journal reported that consumers were reducing their health care spending in response to the current economic slow-down. Both the number of prescriptions filled and the number of office visits dropped between 2007 and 2008. In one survey 22% of consumers reported going to the doctor less often and 11% reported buying fewer prescription drugs; this may explain why on January 10, 2012 it was reported that the rise in health care costs was its lowest in 51 years.

The Emergency Medical Treatment and Active Labor Act (EMTALA) of 1986 - is considered a critical element in the "safety net" for the uninsured but it established no direct payment mechanism for such care. Indirect payments and reimbursements through federal and state government programs have never fully compensated public and private hospitals for the full cost of care mandated by EMTALA. Emergency health care is generally more expensive than an urgent care clinic or a doctor's office visit especially if a condition has worsened due to putting off needed care. More than half of all emergency care in the US now goes uncompensated and has contributed to financial pressures on hospitals in the last 20 years causing them to consolidate and close facilities and contributing to emergency room (ER) overcrowding. According to the Institute of Medicine between 1993 and 2003 ER visits grew by 26% while the number of emergency departments declined by 425. Emergency rooms are typically at, near, or over capacity. Long wait times have become a problem nationally and in urban areas some ERs are put on "diversion" on a regular basis, meaning that ambulances are directed to bring patients elsewhere.

Charity care for those who cannot pay is sometimes available and is usually funded by non-profit foundations, religious orders, government subsidies, or services donated by the employees. Massachusetts and New Jersey and the city and county of San Francisco, California have programs for health care when the patient cannot afford to pay (limited to those residents whose incomes and net worth are below an eligibility threshold). Some cities and counties operate or provide subsidies to private facilities open to all regardless of the ability to pay; means testing is applied and some patients may be charged for the services they use. The universal health care system adopted through the Massachusetts 2006 Health Reform Statute in part has earned Massachusetts the #1 spot in the country for its doctor to patient ratio. In July 2009 Connecticut passed SustiNet into law with the goal of achieving health care coverage of 98% of its residents by 2014. In 1997 of the immigrants who became US citizens 18.5% were uninsured, non citizens were 43.6% uninsured and 14.2% of native-born Americans did not have health insurance coverage. Without charity, government subsidies or donated services uninsured people who need care would end up in the more expensive EMTALA care via ERs. A national health care program should reduce the overall cost to hospitals as people would be able to get preventive care via doctor visits and be able to go to urgent care clinic instead of ERs. By doing this we should also be able to provide better and more efficient ERs.