Subscribe Now
Forgot Password?

Weekly News, Analysis, and Commentary

Legal & Regulatory Feature

Image created by RRY Publications, LLC / Source: Wikimedia
Image created by RRY Publications, LLC / Source: Wikimedia

The Shutdown and Orthopedics

Walter Eisner • Tue, October 1st, 2013

Print this article

What does the government shutdown mean for the orthopedic community?

Not much for now. The shutdown won’t impact Medicare, Medicaid, Social Security or any of the essential government services required to protect the borders, public health and other mandatory functions, including Obamacare.

During the 1995–1996 government shutdown, Medicare continued to pay physicians and hospitals according to prevailing payment rates, since claims are made out of the Medicare trust funds and not current appropriations.

While a government shutdown for any period of time could result in delays in claims processing, audits, and other administrative functions, most essential functions of Medicare, Medicaid, and ACA (Affordable Care Act) implementation will continue to operate under emergency and mandatory funding.

Regulatory Consequences

But there may be regulatory consequences.

According to a statement posted on September 27, 2013 by the U.S. Department of Health and Human Services (HHS), FDA “would continue limited activities related to its user fee funded programs.” The statement said out of a total of 14,779 FDA employees, 6,620 would be furloughed, leaving 8,180 (55%) retained.

FDA would have the staff in place to “continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues…Carryover funding from user fees paid by industry” might also support FDA in a shutdown, continued the statement.

However, HHS said “routine establishment inspections,” some “compliance and enforcement activities,” the “majority” of its laboratory research testing, and the “majority” of its food safety and nutrition testing would not be carried out.

What about regulations and guidance documents ordinarily released by FDA on a regular basis?

The Federal Register Office said that in the event of a government shutdown, it would only publish “documents directly related to the performance of governmental functions necessary to address imminent threats to the safety of human life or protection of property.” FDA would be charged with making this determination for its own documents.

Most of its non-essential staff will be out of the office, so it seems unlikely that the FDA would be publishing regulatory or guidance documents.

Here is where we stand now. The House passed a bill to defund Obamacare. The Senate rejected it, the House then passed another version that would have abolished the devices tax and delay Obamacare for a year. When the Senate rejected that, the House passed another bill that would have delayed the individual mandate and revoked health insurance subsidies for congressional staffers. After the Senate said no to that, the clock ran out and the government shut down. The House has now asked for private negotiations in a conference committee. The Senate said no.

Send to a Friend

The article link will be sent to the email address you provide

Your Name (required)

Your Email (required)

Friend's Email (required)

Comments

One Response to “The Shutdown and Orthopedics”

  1. Thomas Fleckenstein says:

    The government shutdown will affect the orthopaedic industry in a pretty significant way. With the FDA shutdowns OEM’s are not seeing progress on submissions and trials. Those awaiting 510(k) clearance in order to get their product to market could potentially suffer large financial setbacks.

Leave a Reply

Name

Email Address (will not be published)

Website

Comment: