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During recent debates about the healthcare crisis in the United States, an argument often presented is that individuals lacking insurance overuse (or abuse) emergency room departments in order to obtain care. The presumption is that individuals without health insurance will avoid seeing a primary care doctor and then either wait until symptoms are very severe, or even visit the emergency room for routine complaints and care. Unlike other countries where ill patients can be turned away at the door, in the United States everyone must be treated regardless of insurance status or the ability to pay for their care. This seemingly merciful policy can pose a financial burden to hospitals, however, and has raised concern amongst some political commentators and anti-immigration proponents.

In the heated political debates leading up to the 2012 presidential election, anti-Obama-care activists brought up the example of uninsured, illegal immigrants racing to the ER to give birth to their babies without ever having received prenatal care or counseling. Some communities in Arizona have complained about this type of behavior – even claiming that non-US residents rush over the border to give birth in US hospitals where they must be treated. The argument then goes that US taxpayers carry the burden for this type of emergency room use. Labor and delivery can certainly be considered emergency conditions (especially in the case of severe complications), but other complaints for which patients may present themselves at the ER department may not be as severe. These so-called “non-urgent emergency room visits” have been associated in the popular mindset with both overcrowding and increased healthcare costs for everyone.

Contrary to what most people believe, however, the “non-urgent” care costs of a typical emergency room are quite small compared to the total overall costs of running an emergency department. That means that the greater the number of non-urgent cases which present to an ER, the lower the total cost for each will be [1]. It’s also helpful to keep in mind that more minor ailments, such as treatment for a urinary tract infection, will not occupy nearly as much time or analysis from the department as would a major intervention like trauma surgery or treatment for pulmonary embolism (a blood clot in the lungs). So it’s not entirely true that non-urgent visits are a source of huge expenditures for emergency departments.

There is a good reason for patients to limit their use of emergency departments in non-urgent situations, however, and this is because physicians must evaluate anyone who presents in the ER with a complaint. According to a law called the Emergency Medical Treatment and Active Labor Act, which was enacted in 2003, a physician may never discharge or refer a patient elsewhere without first providing what is called “an appropriate medical screening examination”[2]. The medical examination determines whether the patient is truly suffering from an emergency medical condition. While it is likely designed to protect patients and ensure everyone gets access to care, in practice this law means that anyone – even someone with no complaints at all – could walk into an emergency department and request to be seen. The triage nurses and doctors would have no choice but to examine the patient.

All of us should recognize an important point: the more non-urgent cases that appear in the emergency department, the less time physicians will have to adequately treat and care for the severely ill. Thus it is best for everyone if patients avoid seeking emergency care unless they are truly suffering a life-threatening condition or if they are unable to withstand their symptoms long enough to see a general practitioner or their family doctor. As discussed in this article, it is not so much the financial burden of non-urgent emergency room visits that is worrisome – it is the time burden on physicians and nurses in emergency departments.

Useful References

[1] Durand AC, Gentile S, Devictor B, Palazzolo S, Vignally P, Gerbeaux P, and Sambuc, R. ED patients: how nonurgent are they? Systematic review of the emergency medicine literature. The American Journal of Emergency Medicine 2011; 29:333-345.

[2] Emergency Medical Treatment and Active Labor Act (EMTALA), codified as amended at 42 U.S.C. 1395dd, 1990; Heath Care Financing Administration EMTALA Regulations, 42 C.F.R. Parts 488, 489, 1003, 1994.

If you’d like to learn more about the law mentioned in this article, consult the two references provided above. To learn more about urgent care jobs and emergency medicine jobs, visit PhysEmp.com or look for us on Facebook and Twitter.

The MDUFA stands for Medical Device User Fee and Modernization Act. This term is quite self-explanatory. It means the fee the FDA collects from medical device manufacturers to review medical devices and drugs before they get approved to enter the market.

For medical devices, the FDA has made three classes -Class I, Class II and Class III. Class I devices are those that don’t need FDA approval; Class II devices need premarket notification and Class III devices need premarket approval.

Why charge fees?
Now, we have put this question into perspective. A common query that arises in relation to this is that when classes of medical devices that need FDA approval are sent to the FDA for approval, where is the need for the FDA to collect fees for doing its stated objective and duty?

The answer to this question lies in the definition of the term itself -Medical Device User Fee and Modernization Act. As this expansion illustrates, the FDA collects fees both for approval and modernization from medical device and drug makers. It collects fees from medical device and drug manufacturers -varying according to the complexity of the product for which approval is sought -as a means to sustain itself and develop programs for its and the industry’s well-being.

Rates of user fees
The FDA’s charges range between a little over $22,000 for a large manufacturer and $55,000 for a company whose gross receipts are under $30 million. As for 510 (K) submissions for a low-risk medical device, the fee is from just over $2,000 for a small manufacturer to a fraction above $4,000 for a large manufacturer.

Period for approval
Nine-tenths of the submissions are cleared in three months or less. It is for complex devices that more time is usually taken.

Budget allocation and spending
The FDA usually allots budgets under the MDUFA for periods of five years. Its allocated budget is at between $500 million and $600 million for every five years. The main source by which this money is spent is on preparing vital guidance documents. These documents are meant to make the approval process of complex drugs and devices easier. Hence, this is more of a development program budget for the FDA, which uses these funds for the eventual good of the industry and the public.

Industry support and expectations
In this budget, only about a fifth comes from the FDA. The rest is from the drugs and devices industry. These industries sponsor this approval process in return for lesser hassles in approval of their products. The industry also expects the FDA to be more translucent and less bureaucratic in its approval process. It would also want the process to be more predictable, which will help industry players to stick to set processes that make approvals easier and faster. Other expectations from the industry include more streamlined FDA guidance about the approval process, training and professional development for the person or organization that has applied for the review, more reporting on the performance of the program, more interactions that facilitate smoother working between the agency and the organization, and so on.